ZS3 Diagnostic Ultrasound System Service Manual (9.x)

©2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

ZONARE, the ZONARE logo, ZS3 and z.onepro are all trademarks of Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. All other trademarks are the property of their respective holders.

The ZS3 Ultrasound Platform and products derived there from (for example, but not limited to, the ZS3 and the z.onepro with and without the SP UI option) is covered by one or more of the following patents: 6,251,073; 6,569,102; 6,618,206; 6,663,567; 6,685,645; 6,733,455; 6,773,399; 6,866,631; 6,866,632; 6,896,658; 6,936,008; 6,980,419; 6,997,876; 7,022,075; 7,087,020; 7,226,416; 7,238,157; 7,352,570; 7,361,145; 7,510,529; 7,627,386; 7,382,309; 7,699,781; 8,002,705; 8,226,561; D461,814; D462,446; D467,002; D469,539; D469,877

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan, Shenzhen, 518057, P.R.China

Shanghai international Holding Corp. GmbH(Europe)

Eiffestraβe 80, 20537 Hamburg, Germany

CAUTION: United States Federal Law restricts this device to sale by or on the order of a licensed physician or licensed veterinarian.

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TABLE OF CONTENTS 1 Introduction ...... 7 Purpose ...... 8 Definitions/Acronyms ...... 8 Documentation Conventions ...... 10 Symbols ...... 10 2 Safety ...... 12 Facility Needs ...... 12 Notes When Returning or Transporting the System, Probes, and Repair Parts ...... 13 Warning & Cautions ...... 13 3 System Specifications ...... 25 General System Specifications ...... 25 Display...... 27 Battery Pack Specifications ...... 28 Standards and Compliance ...... 33 4 System Overview ...... 35 Major System Assemblies ...... 35 User Interface Overview ...... 36 Keyboard Functions ...... 39 On-Screen “Dashboard” System Status ICONs ...... 42 Accessory Components ...... 44 Rear I/O Panel ...... 45 5 System Uncrating & Installation Procedures ...... 46 Product Shipment ...... 46 Electrical Requirements ...... 46 Environmental and Space Requirements ...... 46 Uncrating ...... 46 Mechanical Inspection ...... 50 System Installation ...... 50 ZS3 System Verification ...... 52 6 Setup ...... 55 System ...... 55 Preset Mgmt ...... 56 Calc ...... 57 Annotation ...... 57

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Body Pattern ...... 57 Protocols ...... 58 Stress Echo ...... 58 DICOM ...... 58 Network ...... 59 Keys...... 59 Peripherals ...... 59 Backup/Restore ...... 60 7 Security ...... 61 Access Control ...... 61 Enabling Location Access Control ...... 62 Enabling Account Access Control...... 63 System Login ...... 63 Local Privilege Management ...... 64 LDAP Privilege Management ...... 70 User Field Name ...... 72 Enable Barcode Login ...... 72 Enable Encryption ...... 73 8 Patient Information Management ...... 74 Patient Information ...... 74 New Patient Information ...... 75 Retrieve Patient Information ...... 80 9 DICOM/HL7 ...... 86 DICOM Preset ...... 87 Service Preset ...... 89 DICOM Verifying ...... 103 DICOM Services ...... 104 DICOM Media Storage ...... 110 10 Peripheral ...... 112 Print Service ...... 112 Barcode Reader Configuration ...... 113 Power Save ...... 115 11 Network ...... 117 Network Setup ...... 117 FTP Setup ...... 122

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QPath/QView ...... 123 VPN ...... 125 12 Functional Descriptions ...... 128 System Capabilities...... 128 Major FRUs ...... 128 13 System Diagrams ...... 133 Power Block Diagram ...... 134 Cabling Diagram ...... 135 System Block Diagram ...... 136 14 Peripherals & Accessories ...... 137 Black & White ...... 137 Color Printer ...... 144 Pedal Footswitch ...... 146 Ultrasound Gel Warmer ...... 146 ZS3 Intracavity probe holder ...... 153 15 Software Procedures ...... 158 Backup Operations...... 158 Restore Operations ...... 159 Software Upgrade & Installation ...... 162 Diagnostic Panel Operations ...... 168 16 Care and Maintenance ...... 177 Overview ...... 177 Basic System Care...... 178 Transducer Maintenance ...... 181 System Check ...... 181 17 Preventative Maintenance Forms ...... 189 18 System Troubleshooting...... 193 Diagnostics ...... 194 Troubleshooting ...... 197 System Status LED & Error Code Definitions ...... 207 Battery Performance – Charge Times - Reconditioning ...... 217 How to Obtain MAC Address ...... 218 19 Replacement Procedures ...... 222 Recommended Tools ...... 222 ZS3 Module – Removal/Replacement...... 223

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Casters – Removal/Replacement ...... 227 19” Display – Removal/Replacement ...... 228 Display Arm – Removal/Replacement...... 233 Cart Battery – Removal/Replacement ...... 239 Power Module – Removal/Replacement ...... 243 User Interface – Removal/Replacement ...... 248 Dock Board/SSD - Removal/Replacement ...... 254 Gas Spring – Removal/Replacement ...... 259 20 Parts Catalog ...... 263 System ...... 264 Display...... 264 Accessories ...... 266 User Interface ...... 270 Module & Cart Electronics ...... 271 Internal Cabling ...... 272 Power Module ...... 273 Miscellaneous Cart Items ...... 274 Peripherals ...... 274 Options and Upgrading Package ...... 275 Revision History ...... 295

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1 Introduction

Mindray Contact Information Asia, Europe and ROW Address Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057, P.R.China E-mail [email protected] Website www.mindray.com Telephone +86 755 81888998 Fax +86 755 26582680

United States and Canada Address 800 MacArthur Boulevard, Mahwah, NJ 07430 Telephone 1-800-288-2121, 1-201-995-8000 Technical Support 1-877-913-9663, 1-650-316-3199 Technical Support Email [email protected] Website www.mindraynorthamerica.com

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Purpose This manual provides information to assist service personnel in performing maintenance, and repair procedures that may be required to support ZS3 Ultrasound System (9.x). The Mindray/Zonare ZS3 Ultrasound System is used for ultrasound evaluation of the following applications: Opthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intraoperative (Neuro); Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans- rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel. Users include ultrasound imaging technicians (sonographers) and physicians. Mindray/Zonare Ultrasound Imaging Systems may be used in a hospital (e.g., imaging laboratory, emergency room, patient bedside, and operating room), medical clinic, physician’s office or a mobile imaging center. Please refer to the ZS3 Instructions For Use for more information.

The ZS3 Ultrasound System consists of two major components: 1) Cart; and, 2) Transducer(s). The Cart contains the software driven imaging electronics and user interfaces (keyboard, monitor, handles, etc.). It houses the , memory, amplifiers and power supplies for the microprocessor. It sends electrical currents to and receives electrical pulses from the compatible transducers. The Cart performs the calculations involved in processing the data to produce the displayed ultrasound images. The ZS3 Cart is available in two options: with or without Echocardiography. The Echocardiography option allows users to perform advanced cardiac and intracardiac imaging and related functions beyond what is available without the echocardiography option.

Included with the system are one or more Mindray/Zonare Curvilinear, Endocavity, Linear, or Phased array transducers allowing for many clinical applications. Accessories include, but are not limited to the Mindray/Zonare ZPAK Battery and off-the-shelf components: bar code reader, foot pedal, printers, biopsy guides, ECG cables and a wireless interface. Case studies can be stored to USB memory stick, and other industry standard archiving devices.

Note: The availability of options may be limited based on country or region of use.

Definitions/Acronyms 2D: Two dimensional (B-Mode, Color mode) BMP: Bit MaP C-Mode: Color Flow Mode (Doppler) D-Mode: Doppler (Pulsed Wave) Mode DICOM: Digital Imaging and COmmunication in Medicine

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DSP: Digital Signal Processing ESD: Electro Static Discharge EV: Endo Vaginal FPGA: Field Programmable Gate Array FRU: Field Replaceable Unit LCD: Liquid Crystal Display LED: Light Emitting Diode M: M-Mode (Motion Mode - Tissue) NTSC: National Television Standards Committee (video standard) PAL: Phase Alternation by Line (video standard) PRF: Pulse Repetition Frequency PW: Pulsed Wave Mode (Doppler) Retrospective: Post-processing performed on frozen images from memory DGC: Depth Gain Compensation USB: Universal Serial

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Documentation Conventions The following alert conventions are used in this manual: Symbols The following symbols may be used in this manual or elsewhere in product labeling.

Symbol Description Information that may relate to safety of the patient, the operator, or the equipment

A type BF patient-applied part (B= body, F= floating applied part)

A type CF patient-applied part (C= cardiac, F= floating applied part)

Alternating current (AC)

Direct current (DC)

Date of manufacture

Manufacturer

Caution: ESD sensitive

Recyclable material

V Voltage Hz Cycles per second Waste Electrical & Electronic Equipment Standard Applies to EU Member States only: this system should not be treated as household waste. Mindray meets the WEEE Standard. For more information on returning or recycling this system, please contact Shenzhen Mindray Bio-Medical Electronics Co. or the distributor from whom you purchased the system. Consult the Instructions for Use

Serial number

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Symbol Description Authorized representative in the European Community

Catalog number

Shipping & Storage: Fragile

Shipping & Storage: Keep dry

Shipping & Storage: Temperature limits

Shipping & Storage: This side UP

Shipping& Storage: Do not stack above this container

Shipping & Storage: Humidity limits

Shipping & Storage: Pressure limits

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).

Protected against water immersion - Immersion for 30 minutes at a depth of 1 meter.

This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93 / 42 / EEC concerning Medical Devices. The number adjacent to the CE marking (0123) is the number of the EU-notified body certified for meeting the requirements of the Directive. MR Unsafe – the system is not intended to be used within magnetic resonance (MR) environment.

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2 Safety

Facility Needs Users should prepare for the materials needed in the site, so as to avoid confusion and complete the task in time without any waste of manpower. Follow the checklist in pre-installation to ensure that the required steps are performed. Action Yes No Schedule enough time for installation Ensure that the operating environment meets the requirements Ensure that you have adjusted the lighting environment to adapt to the condition of the system Ensure that the electrical supply conforms to the standard requirements Ensure that the EMI precautions are performed and all the sources that might possibly cause unwanted interference are removed The system is put in a site according to the requirements Ensure that the network, if required, is ready for the system

Before installation, the users should:  Have the required material ready.  Prepare the site for the delivery of the system.

Note:  This equipment must be operated by skilled/trained clinical professionals.  Before delivering the system, ensure that the operating site is clean. Do not put the system on a carpet that might attract dust and create static. In addition, the EMI should also be taken into account during investigation.  It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.  Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.

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Notes When Returning or Transporting the System, Probes, and Repair Parts When returning or transporting the ultrasound system in the original packaging, ensure that:  The ultrasound system should be adjusted to its lowest height and the monitor should be folded in the down position.  The control panel should be placed in the center and locked. Note: When you return the system, ensure that the system is fully decontaminated, and human fluids or blood are removed from the system, parts or probes. This is to protect those who transports, receives or opens this package.

The US Department of Transportation (DOT) has ruled that “items that were saturated and/or dripping with human blood that are now caked with dried blood; or which were used or intended for use in patient care” are “regulated medical waste” for transportation purpose and must be transported as a hazardous material.

Warning & Cautions It is extremely important to read the following definitions of WARNING information, prior to beginning any service on any sub-system within the system. As you see applicability of each of these noted WARNINGs, during the course of the servicing process, be prepared to avoid harm to persons and equipment by proper adherence.

It is not possible to anticipate every condition and situation in which ultrasound system will be used. The following warnings and cautions represent typical situations that require special attention. User knowledge and experience with a specific application and environment must also be taken into consideration in order to help ensure the safety of personnel and equipment.

Safety Standards All Mindray instruments, cables, and diagnostic ultrasound imaging transducers have been designed to meet the essential requirements contained in 93/42/EEC (Medical Device Directive), and all appropriate requirements contained within IEC 60601 -1, AAMI STD ES 60601-1, CSA STD C22.2 NO. 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), IEC 60601-2- 37 (Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment), IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic Compatibility), including limits for

ZS3 Service Manual Page 13 of 296 current leakage and isolation from a primary power line. Testing for compliance with the essential requirements of the Medical Device Directive has been performed.

Warnings • Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case. • Accessory equipment (analog or digital) connected to the ultrasound system must comply with the relevant IEC standards (e.g., IEC 60950 information technology equipment safety standard and IEC 60601-1 medical equipment standard). Furthermore, all configurations must comply with the standard IEC 60601-1. It is the responsibility of the person, who connects additional equipment to the signal input or output ports and configures a medical system, to verify that the system complies with the requirements of IEC 60601-1. If you have any questions regarding these requirements, please consult your sales representative. • When the wireless LAN function is turned on, the ultrasound system may suffer interference from other equipment, even if that other equipment complies with CISPR EMISSION requirements. • Keep at least 20 cm away from the ultrasound system when the wireless LAN function is in use. • Do not connect or disconnect the system’s power cord or its accessories (e.g., a printer or a recorder) without turning OFF the system power first. This may damage the system and its accessories or cause electric shock. • If the system is powered off improperly during operation, it may result in data damage of the system hard disk or system failure. • Please use the ultrasound gel compliant with the relevant local regulations. • The cover contains natural rubber that can cause allergic reactions in some individuals. • In normal diagnostic ultrasound mode, there is no danger of a normal- temperature burn; however, keeping the probe on the same region of the patient for a long time may cause such a burn. • Do not use the system to examine a fetus for a long period of time. • When using intra-cavity probes, do not activate the probe outside the patient’s body. • Power off the system if you will not use the system for a long period of time (including storage/ transportation condition), and you should not allow the system in standby status, otherwise the batteries will be out of power and permanently damaged. • If you will not use the system for a long period of time, please periodically check the battery and ensure that the battery power is sufficient. Otherwise, the battery may permanently be damaged. If any fault is find during checking, please contact Mindray Customer Service Department or sales representative.

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• To dispose of the system or any part, contact Mindray Customer Service Department or sales representative. Mindray is not responsible for any system content or accessories that have been discarded improperly. • DO NOT touch the Signal I/O ports if in contact with the patient; otherwise patient injury may result. • Do not allow the patient to contact the live parts of the ultrasound system or other devices, e.g. signal I / O ports. Electric shock may occur. • When faults occur during installing or leading the outside protective wire, the ultrasound system should be powered by the internal power supply. • Do not remove any of the System covers other than the module cover. Other than the scan module there are no user-serviceable parts internal to the system. Only trained Mindray/Zonare service personnel should access the system’s internal electronics. • The ultrasound systems contain no operator-serviceable components within the enclosures. To avoid electrical shock, do not remove covers. As with any other electrical equipment, always observe care when operating this instrument. For service issues, contact Mindray/Zonare Technical Support. Failure to follow these restrictions may void your warranty or service contract coverage. • To reduce the risk of electric shock, DO NOT connect the ZS3 system input or output connections to equipment that is not properly connected to an Earth ground. • To achieve proper grounding reliability, the ultrasound system power plug must be fully inserted into a receptacle marked “hospital grade.” Do not remove the grounding wire. If there is any question of power outlet or power cord integrity, do not proceed. Obtain qualified assistance • To maintain proper grounding reliability, use only Mindray/Zonare- recommended peripherals and accessories. Use of non-specified peripherals and accessories could result in risk of electrical shock or injury. • The ultrasound systems represent a potential explosion hazard if used in the presence of flammable anesthetics. • The system does not contain a user-serviceable lithium ion battery. • The optional ZPAK cart battery is not a user serviceable item. Contact Mindray/Zonare’s Technical Support group for assistance with the ZPAK battery. • Follow guidelines provided by relevant IEC standards) when connecting peripherals. • The USB Memory Sticks supplied by Mindray/Zonare are the recommended brand, type, and sizes for use in ZS3 Systems. They have been verified for optimum reliability and performance. • No modification of the system is permitted. Modifying the system may subject the operator or patient to hazardous conditions. • The ZS3 ultrasound system represents a potential explosion hazard if used in the presence of flammable gases or oxygen rich environment. • Use only transducers that are specifically approved for the ultrasound system. If the proper identification of a connected transducer is not displayed on screen, do not proceed with its use.

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• Transducers covers may be contaminated and must be handled accordingly. • Inspect the transducer and ZS3 System before each use. Inspect the transducer face, housing, cable, connectors, and cases. Do not use the unit if damage is detected. • Bent, broken, or missing pins on the transducer connector may cause poor image quality, including possible mirror image artifact. Be sure to check pins before connecting transducer to the Mindray/Zonare ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call Mindray/Zonare Technical Support. • To avoid electrical shock, always unplug the ultrasound system AC power cord from wall outlet before cleaning any part. Do not immerse the transducer past the specified cleaning/disinfection level, as specified in Transducer Cleaning and Disinfection. Do not immerse the transducer for longer than the specified cleaning/disinfecting time. Do not use any transducer that has been immersed beyond the maximum limit or has been soaked longer than the maximum specified time. • Do not allow disinfectant to contact metal surfaces. Always use protective eyewear and clothing when cleaning or disinfecting device. • Disinfectant wipes and topical spray products are not FDA cleared high-level disinfectants and do not provide adequate protection should the transducer become cross-contaminated. • The transducer must be removed from patient contact before application of a high-voltage defibrillation. • The system is not intended for use in conjunction with high frequency (HF) surgical equipment (tissue ablation devices). Do not use transducers connected to the ultrasound system on patients while HF surgical devices are in use. • If using relevant standards compliant equipment that was not provided by Mindray/Zonare, it is required that total leakage currents be tested and validated to be below the IEC 60601-1 chapter 16 limits. • This equipment must only be connected to a supply main with protective earth. • Validate that measured and calculated results shown in Calc Package reports reflect the clinical observations. • Auto-Dop Trace is intended to serve as an adjunct to the diagnostic process in evaluating blood flow during PW Doppler examinations. When using the Auto-Dop Trace feature, please evaluate the results to verify that you are in agreement before committing the values to the Calc Report Package. • Always examine transducers for damage, such as cracks, splitting, holes, or fluid leaks. If damage is evident, discontinue use of the transducer and contact Mindray/Zonare. • Prior to initiating any disinfection process, disconnect the transducer from the ultrasound system. • Ensure that any connected external equipment, such as external monitors, printers and peripherals, comply with relevant standards such as IEC60601-1 and IEC60601-1-2.

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• If an external video monitor is connected to the ZS3 system, it is necessary to ensure that an RF ferrite is clamped to the cable as close to the ZS3 system as possible. Use a ferrite such as Fair-Rite Products Corp. • The potential equalization terminal, located by the AC Mains connection, is connected to the system chassis. It can be connected to corresponding terminals on other equipment to eliminate potential differences. Do NOT use it for additional protective grounding. • Damage to the system may cause poor image quality, including possible imaging artifacts sometimes referred to as ‘halo’ or ‘headlight’ artifacts. Regularly inspect the system for damage and know how to recognize imaging artifacts. • There are many types of system use and system error messages that might be displayed during the use of the ZS3 Ultrasound System. If a message is encountered that is not self-explanatory, contact Mindray/Zonare service for assistance. • Do not touch any of the connector contacts while performing a patient examination to prevent the possibility of a hazardous current path. • Do not expose the device to a magnetic resonance (MR) environment.

Warnings - Ocular Imaging • To avoid injury to the patient, use only the Ocular Preset when imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Ocular Preset is selected

Warnings – Battery • To avoid electrical shock, do not touch the battery contact. • To avoid risk of fire, explosion, or burns: − Do not disassemble or alter the battery. − Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects. − Do not heat or discard the battery in a fire. − Do not expose the battery to temperatures above 60° C (150° F). − Do not charge the battery near a heat source. − Do not leave the battery in direct sunlight. − Do not use a damaged battery. − Charge the battery at room temperature. − Inspect the battery for damage before charging or placing the battery in the ZS3 System. − Do not connect battery to an electrical power outlet.

Warnings – ECG • The ECG and the Respirometer functionality are not intended for ECG diagnosis. It must not be used for intraoperative applications of the heart. Use only the recommended patient cable supplied by Mindray/Zonare. Make sure

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that bare parts of the electrodes and the patient do not come in contact with conductive parts, such as metal examination beds, trolleys, and similar items. • Before defibrillation, always disconnect the ECG cable connector from the system and make sure the connector does not come in contact with other persons or conductive surfaces, such as metal examination beds, trolleys, and similar items. • Operating your system with ECG signals below 0.25 mV may cause inaccurate results.

Warnings – TEE Transducer • The multiplane TEE transducer should be used only by a qualified physician who has received appropriate training in proper operation of the probe and in endoscopic techniques as dictated by current relevant medical practices. • Electrical Hazard: Any evidence of damage indicates the probe cannot be used and should be returned to Mindray/Zonare for evaluation and repair. • Biological Hazard: Adequate cleaning and, if necessary, disinfection are carried out to prevent disease transmission. It is the responsibility of the user to verify and maintain the effectiveness of the procedure used. A single-use, sterile disposable sheath for TEE purposes can be used. • Inspect the transducer connector pins for contamination or damaged pins that might interrupt signal flow through the connection. Be sure to check pins before connecting transducer to the Mindray/Zonare ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call Mindray/Zonare Technical Support. • Immediately replace a transducer that exhibits any damage symptoms. • Before introducing the probe, do not rub or spray the tip of the probe with an anesthetic agent. • Avoid forceful manipulations and excessive force in using the probe that could result in patient injury. • Withdraw the probe only with the deflection control in the unlock mode and with the distal end of the probe straight. • The use of a bite guard is mandatory. Failure to use the bite guard may result in damage to the probe, which could result in a safety hazard. Damage to the probe due to biting is not covered by the probe's warranty. • Check if the maximum deflection of the tip is 90° to 120° upward, 60° to 90° downwards and 30° to 45° left/right. If the deflection shows an unwanted amount of free play or exceeds the maximal deflection angles given above, do not use the probe. Contact the service organization to re-adjust the steering of the probe. In this way, the risk of "buckling" or "U-turning" of the probe in the esophagus is minimized. • Avoid damage to the probe by allowing nothing to protrude beyond the case when closing the lid. • Prior to cleaning any device, turn off the system and disconnect power cord from AC power source to avoid electrical shock. • Always use protective eyewear and clothing when cleaning or disinfecting the transducers.

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• Do not allow the disinfectant to come in contact with metal surfaces (transducer connector). Use a soft cloth and warm soapy water to remove any disinfectant that remains on metal surfaces. • Keep the control handle and transducer connector out of any cleaning or disinfection solutions. The control handle and cable may be cleaned with a damp cloth, but only the distal end of the probe up to the 100cm marker on the P8-3 TEE and 70cm marker on the P8-3m TEE shaft may be placed into a disinfection solution. • Do not use other disinfection methods like Iodine, Steam, Heat or Ethylene Oxide. • When servicing the ZS3 System, always be sure to turn the circuit breaker to the OFF position.

Precautions • Transducers are individually licensed according to system configuration. Only the following transducers are available without an advanced feature configuration: L30-8, P7-3c, C12-4lp, C4-1, C6-2, C6-1, C9-3, C9-3sp, C8-3 3D, C10-3, C18-85, E9-3 3D, E9-3, E9-4, L8-3, L10-5, L14-5w, L14-5sp, L20- 5, P4-1c, P8-3TEE and P8-3mTEE. The A2CW and A5CW transducers are enabled if the system is configured with "CW Enabled", and can be used under either the Echocardiology (optional) or the Advanced Vascular Imaging (mandate) mode. Attempting to use any other transducers will result in an error message. • Be aware of the potential hazards associated with the environment where the ultrasound systems will be used. The systems and/or the external equipment can be damaged if signal levels are not appropriate. If peripheral equipment not specifically authorized by Mindray/Zonare is to be connected to the system, it must meet all applicable electrical safety standards that apply to the system in order to maintain Mindray/Zonare’s safety integrity. Any equipment not supplied by Mindray/Zonare must be approved by Mindray/Zonare. Use of non-Mindray/Zonare-approved equipment may result in an unsafe condition, impair operation of the ultrasound system, impair diagnostic capabilities, and void your warranty or service contract coverage. • Mindray/Zonare transducers have a specific range of acceptable application use. Users are advised to restrict each transducer’s use to those applications. Excessive bending, twisting, pulling, dragging, or compression of transducer cables may cause failure or intermittent operation of the system. Avoid rolling the cart wheels over cables. Use of cable hooks is recommended to minimize chance of damage to cables. • If a transducer that has not been approved and licensed for use with the ultrasound system to which it is connected, or if a licensed transducer is not properly connected, the corresponding transducer identification data will not display on the LCD Display. Imaging will be disabled. Resolve this issue before continuing use.

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• The ultrasound system and/or the transducer could be damaged if a non- approved transducer is connected. • Improper cleaning or disinfection of patient applied parts may cause permanent damage. Carefully review the manufacturer’s directions for any component used with Mindray/Zonare ultrasound systems. MINDRAY assumes no liability with respect to single-use devices that are reused, reprocessed, or resterilized and makes no warranties, expressed or implied (including the warranties of merchantability or fitness for a particular use), with respect to such devices. • Use of peripherals or other equipment not provided by Mindray/Zonare may result in system damage or degraded performance. Carefully review the labeling of any such equipment before connecting to the Mindray/Zonare system. • Improper setting of imaging controls may obscure diagnostically valuable information in the display. The factory default preset maps were preselected as appropriate for most imaging circumstances. Improper user configuration of custom presets may obscure diagnostically valuable information. • Mindray/Zonare ultrasound systems are manufactured in compliance with existing electromagnetic immunity (EMI) and electromagnetic compatibility (EMC) requirements. Use of the systems in the presence of an electromagnetic field can cause degradation of the ultrasound image. • Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon. ESD is common in low humidity, which can be caused by heating or air conditioning. ESD shock occurs when electrical energy is discharged from one body, to a differently charged body. To lessen the occurrence of ESD, use antistatic spray on carpets and flooring, and antistatic mats. • To minimize potential ESD damage and electrical contact contamination, avoid touching the metal contacts for the transducer connections, at both the ZS3 port and the transducer connector. • If the ZS3 System has been moved between environments with extremes of temperature and/or humidity, allow the ZS3 System to rest for at least 30 minutes in a controlled environment before using. • Do not use the ultrasound system if any error message displays on the screen. • Do not block airflow to any ventilation holes on the system. • Do not submerge the transducer past the points indicated in ‘Mindray/Zonare Transducers Cleaning and Disinfection’. • Do not spill liquid on the systems or transducers. • Using a non-recommended cleaning or disinfectant solution, incorrect solution strength, or immersing the transducer deeper or longer than indicated can damage the transducer. Damages linked to the use of disapproved chemicals are not covered under product warranty or service contract. • The use of non-shielded cables may result in increased emissions and decreased immunity to external signals • Operating the systems in the presence of external electromagnetic fields can degrade the quality of the ultrasound image. High-frequency devices, such as

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electro-surgical devices, can produce image artifacts. If required, a review of the local electromagnetic environment may be required to minimize the sources of external noise generators. • The use of non-Mindray/Zonare approved cables and accessories may result in increased radiated emissions as well as decreased immunity to external signal fields. • Before beginning to image a new patient, be sure to conclude any in-progress patient exam by pressing the New Patient key. Failure to do so will result in any subsequent storing of images being mistakenly written to the previous patient exam directory. • Some components or devices such as transducer covers used with Mindray/Zonare systems are for single-patient use only. Reuse, reprocessing, or re-sterilization of these devices may compromise their structural integrity. • Any image sets stored on the system, which are not identified by patient name and number, will be stored with a unique number based off of the system ID. • Exercise care in adjusting all settings to avoid obscuring low-level signals that may have diagnostic value. Improper settings can seriously degrade image quality. • Do not touch exposed metal of transducer connector. • Validate all entries in the Measurement Summary. • Ultrasound imaging capabilities can vary from patient to patient. Ultrasound should be used as one component in a comprehensive diagnostic plan. • Never leave a probe in the disinfection solution for more than the specific time by the disinfection manufacturer. Please refer to the instructions for use that came with the disinfectant for minimal required exposure times. Do not forget to rinse the probe directly after disinfection. • Only use water-soluble acoustic coupling gel. Other coupling gels can cause probe damage. • Long-term exposure to ultrasound should be minimized. Although there have been no confirmed adverse effects produced by diagnostic levels of ultrasound, unnecessary patient exposure to ultrasound energy should be avoided, especially in the Doppler mode. • Use of a non-compatible USB Memory Stick may result in file corruption or long file transfer times. Please confirm proper operation of any memory stick prior to attempting to use for clinical data. • Make sure the ZS3 System has fully completed downloading upgrades, importing/exporting, or collecting log data to the USB Memory Stick before removing it from the ZS3 System. Failure to do so will result in loss of data. • Review the ZS3 DICOM conformance statement before integrating with any PACS system. • Validate Structured Report export prior to clinical use. • Use-time from the optional ZS3 battery pack will vary depending on the system usage and battery conditioning. Ensure the battery is adequately charged before starting a procedure without AC main power. • Export patient studies in a timely manner. Do not use the system storage as the sole location of patient studies for an extended period of time.

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• Total Recall Data (TRI) should not be relied on for primary storage of diagnostic data. Use of TRI across software versions is not guaranteed. • The system is not indicated for differentiation between malignant and benign breast lesions.

Precautions – USB Memory Stick USB Memory Sticks that are purchased from outside sources (besides Mindray/Zonare) may not be compatible for use with the system. Precautions – TEE Transducer • TEE: Perform an electrical leakage test prior to each use of the transducer. See the TEE Maintenance Guide or the TEE Leakage Test Quick Reference Guide for details. • TEE: Examine the transducer prior to each use. See the TEE Maintenance Guide or the TEE Quick Reference Guide for details. • TEE: Clean and disinfect after each use. • TEE: Always use a bite guard. • TEE: Always use single-use probe sheath. • TEE: Ensure articulation locks are disengaged and straighten mechanism during device insertion or extraction from patient. • TEE: Remove the transducer from the patient prior to defibrillation. • TEE: Do not store the disinfected transducer in the carrying case. Only use the case for transportation. • TEE transducer is a delicate medical instrument, handle with care. • The multiplane TEE probe is a precision instrument, which must be handled with care. It may be damaged when dropped or abused. In particular, do not allow the ultrasonic window in the tip to come into contact with a sharp object. Do not touch this window unnecessarily. Never exert force onto the acoustic window. • The transducer connector is not watertight, and should always be kept dry. The control handle, although spray-watertight, should not be immersed. • This equipment contains no operator serviceable components. To prevent electric shock, do not remove any covers or panels. • Never manually deflect the distal tip of the probe; use only the deflection control wheels. • Do not kink, tightly coil, or apply excessive force on the probe cable or shaft. Insulation failure may result. • Under normal conditions at full acoustic power the temperature of the tip does not exceed 42.7°C. Be sure to check at least monthly that the temperature increase of the tip is within limits: − Connect the probe to the Ultrasound system. − Adjust the acoustic power to the highest value possible. − Select Color Doppler mode. − Wait for 2 minutes. − Feel at the distal end of the probe if there is a temperature increase that could be harmful for the patient.

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• When a brush is used for cleaning the transducer, use only a soft brush; coarse/stiff-bristle brushes may cause transducer damage. • Keep the control handle and transducer connector out of any cleaning or disinfection solutions. The control handle and cable may be cleaned with a damp cloth, but only the distal end of the probe up to the 100cm (for adult)/70 cm (for pediatric) marker on the shaft may be placed into a disinfection solution. • During immersion disinfection, never immerse the transducers longer than the specific time recommended by the disinfection manufacturer. Damage may occur to the transducer housing and/or components if disinfection times exceed these recommended limits.

Precautions – Panoramic Imaging • Measurements on a panoramic image are limited in accuracy by the acquisition of the image by the user. • Measurements out of plane are potentially less accurate. • A good B Mode/2D image is important for a high-quality panoramic image.

Precautions – 3D/4D Imaging • 3D: Measurements out of plane are potentially less accurate due to movement of tissue. • A good B Mode/2D image is important for a high-quality 3D/4D image.

Precautions - WIRELESS • WIRELESS: The Mindray/Zonare Wireless option device is an RF Receiver and Transmitter, operating using industry standard 802.11 b/g protocols. Use of the wireless option, in the presence of other high energy RF radiating devices may interfere with the transmission of data to the network interfaces. • WIRELESS: The Mindray/Zonare Wireless option device supports several industry standard security protocols and should be enabled to reduce the chance of patient data, transmitted over the wireless interface from the possible undesired interception of the data. • WIRELESS: Data transmission and reception rates are limited to by the bandwidth of the user’s network infrastructure. A Quality of Service (QOS) level is determined by the number of users on the network, the data being transferred by the users, and distance of the Mindray/Zonare system to the wireless access point and other factors.

Electrical Safety

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• Mindray/Zonare systems meet IEC 60601-1, Class I powered equipment requirements. • The ZS3 ultrasound system complies with the applicable medical equipment requirements published in the European Norm (EN) and International Electronics Consortium (IEC) Harmonized Standards. • The transducers, when used with the ZS3 system, are certified to be in compliance with IEC 60601-1 as Type BF or Type CF applied patient parts. Each transducer or port is labeled accordingly.

Contrast Imaging Cardiac rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in the diagnostic range of MI values. See the Instructions For Use that came with contrast agent being used for details. Medical Ultrasound Safety - General Anyone using Mindray/Zonare ultrasound systems for human exams of any kind should thoroughly understand the implications of such use. The American Institute of Ultrasound in Medicine (AIUM) has published a document titled Medical Ultrasound Safety (AIUM 1994). ALARA is an abbreviation for the principle of prudent use of diagnostic ultrasound by obtaining the diagnostic information at a power output that is as low as reasonably achievable. Diagnostic ultrasound is a technique-dependent imaging modality. To obtain the best possible patient care from any ultrasound equipment, the system must be operated by personnel trained in ultrasound image acquisition and interpretation. Users must become familiar with each of their imaging systems. • Always make sure appropriate transducer is used for study being performed • Always make sure active preset is appropriate for study being performed • Know how to recognize acoustic artifacts in image • Consult AIUM recommended protocols & equipment specifications

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3 System Specifications

This section contains system and accessory specifications. For information on the specifications for Mindray/Zonare authorized peripherals, refer to the manufacturers’ documentation. General System Specifications Type Parameter Value Electrical Power requirements 100-240V~, 50-60Hz, 6A max Power consumption (no 180W (616 BTU/hr) peripherals – max) Power consumption (with 470W (1608 BTU/hr) peripherals – max) Environmental Cooling requirements See power consumption above (operating) Air temperature 0-35°C (32 – 95°F) Humidity 15-80% noncondensing Pressure 700-1060 hPa Environmental Air temperature -20-60°C (-4-140°F) (storage) Humidity 15-90%, noncondensing Pressure 500-1060 hPa

Physical ZS3 system ≤79.5 kg (not including probes) (weight) Power cord 0.6 kg (1.4 lbs.) USB printer & bracket 3.4 kg (7.6 lbs.) Battery & bracket 4.1 kg (9.1 lbs.) Operating weight subtotal 73.4 kg (162.1 lbs.) System shipping 41.5 kg (91.6 lbs.) container Total shipping weight 114.9 kg (253.7 lbs.) Physical Height, max (in operating 151 cm (59.4 in.) (dimensions) use) Height, min (in operating 131 cm (51.5 in.) use) Height, min (display 106 cm (41.7 in.) lowered for transport)

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Width 51.5 cm (20.2 in) Depth 72 cm (28.3 in.)

Type Parameter Value IO Ethernet (1 port) RJ-45 – 10/100BaseT connectors USB 2.0 (3 ports) USB-Type A (Vbus 5.0V, 0.5A max) (1 port) eSATAp External Video (1 port) HDMI 1280X1024 +Wireless Manufacturer B&B Electronics / Quatech Option Manufacturer type: ABDN-ER-DP551U Wireless Technology IEEE 802.11b/g, WiFi compliant Wired Interface 10/100 Ethernet (auto sense), RJ-45 Plug Frequency DSSS, CCK, OFDM Modulation Technology DSSS, CCK, OFDM Modulation Type DBPSK, DQPSK, CCK, BPSK, QPSK, 16QAM, 64QAM Network Access Modes Infrastructure, Ad Hoc Channels USA/Canada: 11 channels Europe: 13 channels France: 4 channels Japan: 14 channels (13 channels for 802.11g) Wireless Data Rate 802.11b = 11, 5.5, 2, 1 Mbps 802.11g = 54, 48, 36, 24, 18, 12, 9, 6 Mbps MAC CSMA/CA with ACK, RTS, CTS Network Protocols TCP/IP, ARP, ICMP, DHCP, DHS, HTTP, UDAP Discovery, TFTP, UDP, PING Receive Sensitivity 54Mb/s = -69dBm 6 Mb/s = -86dBm 1Mb/s = -86dBm Wireless Security Disabled, WEP 64 & 128bit, WPA (TKIP), WPA (AES), WPA2 (AES), 802.1x (EAP), Supports WPA & WPA2 Enterprise, EAP- TLS/MSCHAPV2, EAP-TTLS/MSCHAPv2, EAP-TTLS(MD5), EAP-PEAPv0/MSCHAPv2, LEAP

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Type Parameter Value - Zero host security footprint - Supports Certificate, delivery and management Network Addressing ABDN-ER-DP551U, Client Translation (NAT) Bridge ABDN-ER-DP551U, NAT 3 Router Antenna ABDN-ER-DP551U, Client Bridge ABDN-ER-DP551U, NAT 3 Router Regulatory Approvals Worldwide Certificate Support- FCC Part 15 Class B Sub C Modular Approval, IOC, CE, ETSI EN300 328, ETSI 60950-1, ROHS and WEEE Compliant

Display Parameter Value Display size 19” Resolution 1280 x 1024 Pixel pitch 0.294 mm Minimum contrast 600:1 Connectors Mini-HDMI (video), mini-DIN (power) Rotation Left/Right: 90±5 degree Advanced setup Via on-screen system menus

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Battery Pack Specifications Type Parameter Value Electrical Power rating 15.6V, 15Ah = 234 Wh Chemistry NiMh Physical 4kg (10 lb.) (weight) Operational Operating time duration Up to 1.5 hours (fully charged) Physical Height 75 mm (3 in.) (dimensions) Width 260 mm (10 in.) Depth 355 mm (14 in.)

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No Transducer Parameter 1. C10-3 • Penetration Depth: ≥80 mm • Number of Elements: 64 • Field of View: 80 degrees • Radius of Curvature: 16 mm • Ultrasound Bandwidth: 10-3 MHz

2. C9-3 • Penetration Depth: ≥80 mm • Number of Elements: 128 • Field of View: 67 degrees • Radius of Curvature: 33 mm • Ultrasound Bandwidth: 9-3 MHz

3. C9-3sp • Penetration Depth: ≥120 mm • Number of Elements: 128 • Field of View: 67 degrees • Radius of Curvature: 33 mm • Ultrasound Bandwidth: 9-3 MHz

4. C6-2 • Penetration Depth: ≥180 mm • Number of Elements: 128 • Field of View: 65 degrees • Radius of Curvature: 50 mm • Ultrasound Bandwidth: 6-2 MHz

5. C4-1 • Penetration Depth: ≥180 mm • Number of Elements: 64 • Field of View: 80 degrees • Ultrasound Bandwidth: 4-1 MHz

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6. L14-5sp • Penetration Depth: ≥60 mm • Number of Elements: 128 • Field of View: 26 25 mm • Ultrasound Bandwidth: 14-5 MHz

7. L14-5w • Penetration Depth: ≥60 mm • Number of Elements: 192 • Field of View: 55 mm • Ultrasound Bandwidth: 14-5 MHz

8. L10-5 • Penetration Depth: ≥100 mm • Number of Elements: 128 • Field of View: 38 mm • Ultrasound Bandwidth: 10-5 MHz

9. L8-3 • Penetration Depth: ≥100 mm • Number of Elements: 128 • Field of View: 38 mm • Ultrasound Bandwidth: 8-3 MHz

10. E9-4 • Penetration Depth: ≥80 mm • Number of Elements: 128 • Field of View: 135 degrees • Radius of Curvature: 12 mm • Ultrasound Bandwidth: 9-4 MHz

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11. P4-1c • Penetration Depth: ≥180 mm • Number of Elements: 64 • Field of View: 84 degrees • Ultrasound Bandwidth: 4-1 MHz

12. A2CW • Number of Elements: 2 • Ultrasound Frequency: 2.0MHz • Ultrasound Bandwidth: n/a

13. A5CW • Number of Elements: 2 • Ultrasound Frequency: 5.0MHz • Ultrasound Bandwidth: n/a

14. C8-3 (3D) • Penetration Depth: ≥130 mm • Number of Elements: 128 • Field of View: 79 77 degrees • Ultrasound Bandwidth: 8-3 MHz

15. E9-3 (3D) • Penetration Depth: ≥80 mm • Number of Elements: 128 • Field of View: 135 degrees • Ultrasound Bandwidth: 9-3 MHz

16. P8-3TEE • Penetration Depth: ≥80 mm • Number of Elements: 64 • Ultrasound Bandwidth: 8-3 MHz

17. L20-5 • Penetration Depth: ≥50 mm • Number of Elements: 192 • Ultrasound Bandwidth: 20-5 MHz

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18. P8-3mTEE • Penetration Depth: ≥80 mm • Number of Elements: 48 • Field of View: 90 degrees • Ultrasound Bandwidth: 8-3 MHz

19. C18-5 • Penetration Depth : ≥30 mm • Number of Elements: 192 • Field of View: 54 degrees • Radius of Curvature: 41 mm • Ultrasound Bandwidth: 18-5 MHz

20. C6-1 • Penetration Depth: ≥180 mm • Number of Elements: 128 • Field of View: 70 degrees • Radius of Curvature: 62 mm • Ultrasound Bandwidth: 6-1 MHz

21. E9-3 • Penetration Depth: ≥80 mm • Number of Elements: 128 • Field of View: 138 degrees • Radius of Curvature: 12 mm • Ultrasound Bandwidth: 9-3 MHz

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22. P9-3ic • Penetration Depth: ≥60 mm • Number of Elements: 64 • Field of View: 80 degrees • Ultrasound Bandwidth: 9-3 MHz

23. L30-8 • Penetration Depth: ≥30 mm • Number of Elements: 128 • Ultrasound Bandwidth: 8-30 MHz

24. P7-3c • Penetration Depth: ≥180 mm • Number of Elements: 64 • Field of View: 84 degrees • Ultrasound Bandwidth: 3-7 MHz

25. C12-4lp • Penetration Depth: ≥40 mm • Number of Elements: 128 • Field of View (Adjustable): 65° • Ultrasound Bandwidth: 4-12 MHz

Standards and Compliance The ZS3 system has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards. IEC 60601-1: 2012: Medical electrical equipment part 1: General requirements for basic safety and essential performance. IEC 60601-1-2: 2014: Medical electrical equipment part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic disturbances - Requirements and tests. IEC 60601-2-37: 2015: Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment issued by IEC in 2015.

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IEC 60601-1-2: 2014 Certification

Specification Compliance

CISPR 11 – RF emissions Group 1, Class A The ZS3 system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. IEC 61000-3-2 harmonic emissions Class A

IEC 61000-3-3 voltage Complies fluctuations/flicker emissions

IEC 61000-4-2 electrostatic discharge Compliance level: (ESD) ±6 kV contact ±8 kV air Electromagnetic environment guidance: Floors should be wood, concrete, or ceramic tile. If floors are covered with a synthetic material, the relative humidity should be at least 30%. IEC 61000-4-3 Radiated Field Immunity Compliance level: 80MHz - 2.5GHz 3V/m, 80%@2Hz

IEC 61000-4-4 electrical fast transients Compliance level: (EFT) ±2 kV for AC Mains ±1 kV for I/O lines Electromagnetic environment guidance: Main power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-5 surge Compliance level: ±1 kV differential mode ±2 kV common mode Electromagnetic environment guidance: Main power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-6 Conducted Immunity Compliance level: 0.15MHz - 80 MHz 3Vrms @ 2Hz

IEC 61000-4-8 power frequency (50/60 Compliance level: Hz) magnetic field immunity 3A/m, 50/60Hz Electromagnetic environment guidance: Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment. IEC 61000-4-11 voltage dips, short Electromagnetic environment guidance: interruptions, and voltage variations on Main power quality should be that of a typical commercial or power supply input lines hospital environment.

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4 System Overview

Major System Assemblies

Figure 4.1-ZS3 System

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User Interface Overview

Figure 4.2- ZS3 Full Featured User Interface is shown above.

Figure 4.3 - ZS3 Special Procedures User Interface is shown above

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USER INTERFACE FUNCTIONS Note: Not all controls are available on the SP user interface. Features and functions not directly accessible via hard key are still available however via menus. No Sign key Description 1. Setup Used to bring up the SYSTEM SETUP configuration menu.

2. F1 – F8 Function keys, user configurable in System Setup menu.

3. M-mode Press to enter M-mode; Rotate to adjust gain.

4. D-mode Press to enter Doppler mode; Rotate to adjust gain.

5. ZOOM Initiates the variable image magnification process.

6. C-mode Press to enter Color Doppler mode; Rotate to adjust gain.

7. B-mode Press to enter B-mode (2-D); Rotate to adjust gain.

8. Exam Brings up Exam Type/Presets Type configuration menu, and six user Preset setting to OLED display windows. 9. Transduce Used to bring the available r (MTP) transducers to the OLED display windows, for selection of a desired transducer from the 3- Port MTP panel and 1 CW port. 10. Depth Adjusts (Up/Down) the imaging depth of the display.

11. Frequency Enables increasing/decreasing transmit frequency.

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12. Select Toggles between active modes such as dual pane and caliper as well as image manipulation. 13. Store1/2 Press to store the displayed image to the storage device (programmable). 14. Set Provides primary functionality and navigation such as selecting, calculation, setting, moving, or editing etc.

15. Freeze Halts or re-starts active imaging on the display.

16. Optimize Dual function: “ZST” Sound Speed Correction and/or “AutoOpt” (DGC). 17. Caliper Multi-function key: 1) Brings up dynamic caliper (live) or Calc menu (frozen) 2) Toggles on/off the Auto-Dop Trace function, in PW Doppler mode. 18. Calc Brings up the Calculations menu page.

19. Pointer Brings up an arrow pointer which is used to: 1. Operate the menu. 2. Click on thumbnails. 3. Click on soft mode switch control. 4. Click on OLEDs to page, 5. Click on System ICONS. 20. Undo Removes the calculations calipers and return to the Calc menu. 21. Report Displays Report page from the current exam.

22. Used for positioning the cursor, defining size/position of ROI in color mode, positioning measurement tools, reviewing cine-loop images and navigating form/tables/worksheets/reports.

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23. Priority Press to cycle through different menus the Priority key while multiple imaging mode menus are available, for example M, B and Cine modes. 24. DGC DGC Slide pots Changes gain of image at discrete depths (8 Sliders). 25. Print Prints an image to a printer or stores an image or clip to media, depending on

configuration. 26. Dual Mode Activates/deactivates DUAL imaging mode.

27. Annotation Press to display the Annotation softkeys for the selected exam/preset and transducer. 28. Protocol Used to enable controls for Stress Echo or Automatically Tutorial Workflow protocols.

Keyboard Functions

Figure 4.4-ZS3 keyboard keys and function

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Key System Control Description This is a toggle key. The first press will display the Patient 1 NEW PATIENT Information page. The second press will return to the imaging display. If there is an exam in progress, pressing this key will display the in-progress exam's images, most recently stored image displayed 2 CURRENT EXAM first. If there is no exam in progress, pressing this key will have no effect. This key only works when in in-progress exam review or archived exam review. Pressing this key will display the previous image, or 3 PG BACK page of images if in a multi-image display format. Once the first page is reached, the key press will have no effect. This key only works when in in-progress exam review or archived exam review. Pressing this key will display the next image, or 4 PG FWD page of images if in a multi-image display format. Once the last page is reached, the key press will have no effect. This key only works when in in-progress exam review or archived exam review. Pressing this key will toggle between the first stored 5 FIRST LAST image (or first page of images in a multi-image display format) and the last stored image (or last page of images in a multi-image display format). This key only works when in in-progress exam review or archived exam review. When an image has been selected, pressing the Delete key will tag the image for deletion by drawing a red X 6 DELETE through it. If the selected image already has been tagged for deletion (red X) pressing the Delete key will remove the red X, untagging the image. This key only works when in in-progress exam review or archived exam review. Pressing this key will toggle between the following 7 FORMAT image formats: 2 x 2, displaying 2 rows of 2 images (4 images); 3 x 2, displaying 2 rows of 3 images (6 images); and a full-size image. This is a toggle key. The first press will display the Patient 8 ARCHIVE Selection Table. The second press will return to imaging. When an exam is in progress, pressing the End Exam key will 9 END EXAM close the exam. If no exam is in progress, pressing this key will have no effect. This is a toggle key. The first press will display the DICOM Task 10 DICOM QUEUE Management page. The second press will return to imaging. CARDIAC Option Systems ONLY: This is a toggle key. The pressing of this key will activate ECG operation and display the 11 ECG ECG trace on the monitor. A repeat press will turn off this function. This is a dual-function key. A “quick” momentary press is a 12 SERVICE shortcut to bring up the USER DIAGNOSTIC PANEL screen. An

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Key System Control Description “extended” press will trigger a capture of a set of current LOG files to the internal archive This is a toggle key. The first press will display the biopsy needle 13 BX GUIDE path guide. The second press will remove the biopsy needle path guide. This is a cycling key. Pressing the Body Pattern key will display a 14 BODY PATTERN Body Pattern for the Exam Type in use. Pressing the key will cycle through available Body Patterns, including a blank. Pressing Del Text will remove all text annotations and arrow DEL TEXT | DEL graphics displayed. Pressing Shift+Del Word will delete the most 15 WORD recently entered text annotation, whether it be free text, POT, or List entry. Pressing Home will move the text annotation cursor to its default 16 SET | HOME home position. Pressing Shift+Set Home will set the current cursor position as the new Home position. Alternate Graphics. Used in conjunction with the QWERTY 17 ALT GR keyboard, to enable access to international characters. Pressing Text will display the text annotation cursor. Pressing 18 TEXT Text again will remove the text annotation cursor. This is a toggle key. It works when the image is live or frozen. 19 ARROW Pressing the key displays an arrow graphic in the middle of the display. Up to 15 arrow may be displayed simultaneously. This is a cycling key. Pressing this key will cycle between LONG TRANS 20 displaying LONG, TRANS, SAG, and COR, for selection as pre- SAG COR created text annotation. This is a cycling key. Pressing this key will cycle between 21 RT LT displaying RIGHT and LEFT, for selection as pre-created text annotation. This is a cycling key. Pressing this key will cycle between 22 PROX MID DIST displaying PROX, MID, and DIST, for selection as pre-created text annotation.

23 LIST 1 Pressing List1 key will display a list of text items entered in List 1.

24 LIST 2 Pressing List 2 key will display a list of text items entered in List 2.

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On-Screen “Dashboard” System Status ICONs If the system is equipped with the on-board battery option, a battery icon will be displayed in the lower-left hand corner of the LCD display of the ZS3.

Icon Function Status Description Battery System running on AC Power, and Battery Status is fully charged.

Battery System running on AC Power, and Battery Status is currently charging.

Battery Battery is currently undergoing a Status “Reconditioning” process (approx. 12 hours).

Battery Battery status is currently unknown. Status Battery System running on Battery source power Status (more than 25% remaining charge).

Battery System running on Battery source power Status (10%-25% remaining charge).

Battery System running on Battery source power Status (less than 10% remaining charge).

Removable Removable storage media (USB) is being Media initialized. (USB)

USB Local Local USB printer is connected/active. Printer

Network Network connected and active.

Network Network disconnected.

Network Network connecting.

Network Network transfer has an error (Re-Queuing of job, etc.) preventing transfer.

Wireless Wireless network connected and active. Network

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Icon Function Status Description Wireless Wireless Network disconnected. Network

Wireless Wireless Network transfer has an error Network (Re-Queuing of job, etc.) preventing transfer.

Wireless Wireless signal strength: 1% – 33%. Network

Wireless Wireless Network Wireless signal strength: Network 34% – 66%.

Wireless Wireless Network Wireless signal strength: Network 67% –100%.

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Accessory Components

Footswitch Option

An optional remote two-pedal footswitch is available for the ZS3 system. • The footswitch connects to the system using any one of the free USB ports on the cart. • The left and right pedals may be individually configured to one of 72 possibilities including Freeze and Store.

USB Memory Sticks

The ZS3 system uses removable media (e.g., USB memory sticks) for two purposes:

Figure 4.5-ZS3 • Software installer and user preset; system backup • Patient image archive NOTE: You can insert a USB memory stick while the ZS3 system is powered on or off.  To Insert USB Memory Stick 1. Plug the USB memory stick into any available USB port. 2. Make sure the stick is correctly oriented for the port. When a USB memory stick is plugged in to a USB port, a status icon is displayed on the bottom left of the imaging screen.  To Remove USB Memory Stick 1. Make sure the ZS3 system has fully completed downloading upgrades, importing/exporting, or collecting log data to the USB memory stick before removing it. Failure to do so results in loss of data. 2. Firmly grasp the USB memory stick and pull it out all the way. WARNING: The USB memory sticks supplied by Mindray/Zonare are the recommended brand, type, and size for use in ZS3 systems. They have been verified for optimum reliability and performance. If you purchase your own USB memory stick, Mindray/Zonare is not responsible for any errors associated with file corruption or file-transfer time increases.

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Rear I/O Panel

Figure 4.6-ZS3: Rear I/O Panel

FUNCTIONS: I/O CONNECTORS # Function Direction 1 Ethernet 10/100BaseT - (Network) Input/Output 2 Serial Port - eSATAp Input/Output 3 USB Port Input/Output

4 HDMI Connector (video and audio) Input/Output

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5 System Uncrating & Installation Procedures

Product Shipment Shipping containers should be inspected for damages, and the "shock watch" and "tilt watch" indicators for signs of mishandling during shipment. If any problems are found, make notes of any discrepancies and immediately report to the shipping carrier and to Mindray/Zonare’s shipping department representative.

All installation and set-up of equipment should be done following this official Mindray/Zonare product installation procedure. Electrical Requirements Medical Grade Receptacles grounded (3-Prong) 110-120 VAC, 15 amp, 60Hz. wall outlets (or proper 220-240 VAC outlets for systems configured for these power requirements) are required for the ZS3 ultrasound system. Environmental and Space Requirements The ZS3 ultrasound system may be located anywhere within the facility, as long as there is appropriate power outlets and remote network connectivity (at facilities utilizing a DICOM print/storage device hook-up). Uncrating 1. Prior to opening any packaging, inspect the "shock watch" and "tilt watch" indicators (attached to the outside of the main shipping box) for signs that the system has been subjected to shock or tilt conditions during shipment. 2. Also inspect the shipping container for any visual signs of rough handling or abuse during shipment. 3. If any discrepancies from shipment are noted, follow the instructions listed in the “Product Shipment” section above. 4. Remove all banding straps surrounding the cardboard main shipping container.

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Banding strap

Figure 5.1-ZS3 5. Lift off the top cover portion of the main cardboard shipping container, and set aside.

Figure 5.2-ZS3 6. Remove the small boxes containing the transducers (a maximum number of 4) and the small box containing accessories from the inner storage box area (resting atop the ZS3 System).

Figure 5.3-ZS3

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7. Lift the inner storage box upwards, and remove it from the main shipping container. 8. Grasping the sides, slide the cardboard main shipping box upwards, exposing the ZS3 system. Continue lifting until the cardboard box can be completely removed, and set aside.

Figure 5.4-ZS3 9. Remove the protective foam in the back of the display, and pull forward the upper foam of the display

Figure 5.5-ZS3 10. Use Velcro to stick the wooden ramp and the front support board, and put one side of the wooden ramp downward to the ground.

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Velcro

Figure 5.6-ZS3 11. Remove the accessory box, containing front cover and left/right storage box, upon the front support board.

Accessory box

Figure 5.7-ZS3 12. Remove the puller strap around the front support board according to the puller strap indicator label, and remove the front support board.

Puller strap

Figure 5.8-ZS3 13. Inspect the entire ZS3 system for damage, paying close attention to the LCD display on the Cart. 14. Move the ZS3 system to the installation area.

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Mechanical Inspection • Ensure wheels and brakes function properly • Raise and lower the Cart height adjuster (pull release lever located on the right of the system), to verify smooth operation and positive locking. • Ensure the LCD display monitor rotates and adjusts properly • Ensure the ZS3 module is securely attached in the Cart. • Immediately report any mechanical discrepancies to Mindray/Zonare. • The system is shipped with the ZPAK circuit breaker in the “Off” position. If it is not in the “Off” position, push the plunger in before connecting to AC.

Figure 5.9-ZS3 System Installation 1. Check to ensure all peripherals, software level, and serial numbers correspond with sales order. Make note of any missing items or discrepancies, and immediately report to Mindray/Zonare.

WARNING To prevent possible damage to the electronics of the system from condensation, the following warning must be observed: If the system has been subjected to an environment during shipping/transport that differs greatly in temperature and/or humidity, from the environment where it has been moved for installation/intended

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operation, the unit should be allowed to stand for a period of no less than 30 minutes prior to powering on. NOTE: The Module will normally come already installed in the cart when shipped. However if the Module is removed for any reason, the steps below are provided to guide in performing the docking process.

DOCKING MODULE INTO ZS3 ULTRASOUND SYSTEM 1. Place the Module in the docking area on the cart. 2. Slide the module to the back, ensuring the docking connector is properly aligned. 3. Latch in the side locking mechanisms to secure the Module in place. 4. Reinstall the front cosmetic cover. NOTE: the system can’t be powered on without the module and module cover in place.

Figure 5.10-ZS3: Module Docking in Cart

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WARNING To maintain the integrity of the electronic equipment within the ZS3 ultrasound system, it is critically important that a specific sequence be followed at all times, for turning ON or OFF system power. The sequences listed below should always be followed. ZS3 System Verification 1. If the Z-PAK battery pack option is installed, the battery pack circuit breaker located at the back of the battery pack should already be in the closed position. If it is not, gently push the plunger in to close the circuit before applying AC to the cart.

Figure 5.11-ZS3 LED#3 will flash indicating the Cart Power microcontroller is operating.

2. Verify the socket of the AC power cord is fully inserted into the inlet in the back of the cart. 3. Connect the plug of the AC power cord into a Hospital Grade receptacle. 4. Make sure the AC Main Circuit Breaker on the ZS3 System is in the “1” (ON, pushed in on the LEFT) position (see illustration below).

Figure 5.12-ZS3

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LED Status 1. LED #1 should illuminate indicating AC power is present. 2. LED #2 will flash if the cart battery is installed and charging. 3. LED #5 will illuminate indicating the main 24VDC supply is On

NOTE: The ZS3 ultrasound system has the ability to be powered by AC or battery (IF the Z-PAK battery pack “Option” is ordered). When fully charged the battery should allow for normal system operation up to 1.5 hours. 5. Locate the grey power button at the top/right on the module. Press and release the On/Off button to power on the ZS3 ultrasound system (as shown below).

Figure 5.13-ZS3

On/Off Button Status • The Green backlight for the button will begin to flash as the system boots- up. • Once the system is booted, the Green Backlight will be steady On. • Abnormal conditions will be indicated with an Amber colored backlight.

6. Verify that the System is functioning correctly by performing a basic test. This test is comprised of the following: • Attach a transducer (if not already connected) • Verify LCD display is functioning correctly by watching the boot and verifying that normal imaging is displayed after fully booted. • Verify Audio from the Display assembly – Enter PW, turn up the PW Gain and increase volume • Verify that the User Interface keys are functioning correctly • Test USB ports on front of system • Test and Verify Network Connectivity (if applicable)

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• Test and Verify USB Peripheral Connectivity and Functionality (if applicable) 7. Verification is complete – return system to normal operation.

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6 Setup

The Setup function is designed to set the configuration parameters of system operation and user data workflow maintenance. The setup data of the user and system are stored to the hard drive, and should be backed up to USB memory device.

 To enter Setup: Press the key on the keyboard. The following tabs are available for customization.  To exit Setup: Select [Save] in the Setup menu. The parameter settings are saved. Select [Cancel] in the Setup menu or press to close the Setup menu. When you change the system language and click [OK] in the Setup menu, the system automatically shuts down to make the modification effective.  Basic operations The commonly-used setting types are:  Text box: position the cursor over the corresponding field box. Enter the desired value using the keyboard or soft keyboard on the soft menu.  Radio button: click the button to select an item.  Check box: click the checkbox to select one or more options.  Drop-down list: click the arrow beside the list to select an item.

System The system automatically enters the [System] screen after you enter Setup.

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Page Description of Control

Region Enter the hospital name, language, time zone, time format, and system date/time. General Enter patient information, exam setup, patient management, storage, system dormancy, auxiliary output settings etc. Image Enter general parameters in imaging modes (power up, dual, TEE, cine flush, probe change, Doppler, Optimize, cine play, target offset etc.) Application Enter the measurement settings (by exam type) and preferences including AutoTrace. OB Formula Enter relevant information regarding fetal gestational age, fetal growth formula and fetal weight. Audio/Video Enter monitor, audio and external video settings Security Enable/Disable Location Management. Once enabled, users may Verify current location; or Change/Configure Locations by pointing to or clicking on the onscreen Location Management System ICON and following the onscreen prompts. Customize User Account access (Security) • add/delete users • control passwords • edit privileges • LDAP configuration Enable/Disable and set passwords for Exam Data Encryption.

Preset Mgmt

Page Description of Control

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Enable / Disable Select transducer, category and preset combinations that will be available for selection. Exam Type can be disabled independent or transducer/preset. Customization Assign Exam Type and Preset to softkey OLED controls for easy access Delete Select User Presets for deletion by transducer and category. This page is also accessible by pressing the Delete softkey when Exam Type is active. Create/Modify Create or modify presets or define which preset is default by probe. These functions are also available on the softkey OLEDs when the user presses the Exam Type button. Select and follow onscreen prompts.

Calc

Page Description of Control

Calc Select calculations package, calculation menu content, and order of calculations in the display for 2D, M Mode and Doppler (by exam type). Caliper Select measurements, and order of menu items available for 2D, M Mode and Doppler (by exam type) Report Select, modify and create report template for each exam types. Annotation

Page Description of Control Preset Assign pre-defined annotations lists to softkey (OLEDs) by category and Configuration preset. Select arrow and annotation default color. Define Define the name, contents and order of pre-defined annotation lists that will Lists be available for assignment to softkeys (OLED). Body Pattern

Page Description of Control

Define Create body pattern libraries and contents. Assign default libraries available by category and preset.

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Protocols

Page Description of Control Protocols Link protocols to exam types so when an exam type is active and the user presses the Protocol key, specific protocols are available for selection. Create user defined protocols and assignments to presets. Stress Echo

Page Description of Control Protocol Create, edit, import, load, and delete SE protocols Maintenan Select and configure onscreen labels, ROI type, and default WMS type. ce Customize or reset clip triggers.

DICOM Page Description of Control Storage Configure a DICOM destination including AE Title, port, transfer specifics and options, and image/clip specifics and options. Print Configure a DICOM printer destination including AE Title, port, transfer specifics and options, image/clip specifics and options, and print specifics and options. Worklist Configure a MWL source including AE Title, port, and data transfer specifics. MPPS Configure Modality Performed Procedure Step which is used to send exam state information to the configured server. This facilitates the other systems in obtaining the exam progress in time. Storage Configure storage commitment parameters including AE Title, port, Commitment transfer specifics and options.

Query / Retrieve Configure parameters of querying and retrieving patient exam records in a designated server, including AE Title, port, transfer specifics and HL7 Query Configureti network specifics relating to HL7 HL7 refers to the medical information exchange protocol on the seventh layer (application layer) of the Model of the Open System Interconnection published by ISO. It is established by Health Level Seven International in 1987. HL7 is mainly used for standardizing the communication between HIS/RIS system and the other devices, reducing the information interconnection costs among hospitals, and improving the data usability for hospital information system.

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Network

Network Description of Control

Network Configure network specifics including IP address, Gateway, Subnet Mask, MAC address FTP Configure an FTP destination including IP Address, password, port, and data transfer mode.

QPath/ Configure (import, backup, restore, and delete) QPath worksheet linkages Q-View and passwords Configure Q-View, which is a client viewing tool for the server. The primary purpose of Q-View is to provide remote access to Q-Path from the ultrasound system, thereby, allowing the users to complete the exam report on the ultrasound system and submit. VPN Configure a Virtual Private Network (VPN) connection including Server IP, Group, User Name and Password to allow for encrypted transfer.

Keys

Keys Description of Control

Programmab Configure exam category (Cardiac, Abdominal, Obstetrics, Gynecology, le Keys Vascular, Pediatrics, Urology, POC, and Small Parts) specific programmable keys including Function keys, and Footswitches. Selections are also available to configure the B Mode Knob (B Mode or B Mode Home) and trackball speed which are not category specific.

Image Store / Configure capture type (cine/still, image/screenshot), storage destination of Print Buttons Store 1, Store 2, and Print Keys, Reports, and transfer type (exam in progress or end exam).

Store Configure compression level/quality for image storage. Select clip configuration assignment (All Presets or Preset Specific)

Peripherals

Peripherals Description of Control

Print Setup a local printer. Service Barcode Configure a barcode reader i.e. fields to match, worklist options, and Reader barcode reader device assignment. Configuration

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Power Configure system to enter sleep mode and shutdown when on battery and Save external power.

Backup/Restore

Backup / Description of Control Restore To initiate a Backup or Restore of Presets and System data to and from a Backup/Resto USB device. re To restore factory defaults of Preset and System files.

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7 Security

Access Control

The system supports two user types: system administrator and operator.  Administrator The system administrator can access all function modules, and view all patient data, such as patient information, images and reports, etc. Only one administrator is configured by default. The administrator can add or delete operators.  Operator The operator can only access the function modules with assigned privileges (for details about privilege assignment, please refer to "Local Privilege Management" and "LDAP Privilege Management"). Each operator’s access is limited to exams created by him/her and the associated exam information, e.g. patient information, images and reports, etc. The operator does not have access to exam data created by other operators..

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Enabling Location Access Control The “Location” option supports cases where a User has a need to physically move their system from one facility (location) to another on a regular basis. This function addresses cases where this movement includes connecting to a unique network at each location, for sending to DICOM devices, and those network connections consist of different IP addresses and/or target DICOM devices. The “Location” feature allows for simultaneously having multiple configurations saved on the system, and the ability to quickly toggle between those settings by merely changing “Locations” in the menu. The parameters that are saved as a unique “Location” using this feature are as listed below: [Setup] → [System] → [DICOM] page settings (DICOM settings) [Setup] → [System] → [Network] page settings (FTP service) [Setup] → [System] → [Print] page settings (Print service) [Setup] → [System] → [Region] page settings (Institution, language, and time) [Setup] → [System] → [Keys] page settings (Programmable key) [Setup] → [System] → [Network] page settings (QPath/QView service) [Setup] → [System] → [Network] page settings (Network/VPN)

1. Enter [Setup] → [System] → [Security]; 2. Select [Enable Location Management] and click [Save] to exit the preset page; 3. Click the button in the bottom-left corner of the screen; 4. Select [Configure], and select [Add] to bring up the following page;

5. Enter the desired user-defined name to be used for the new "Location", and click [OK].

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Enabling Account Access Control The system administrator can preset the access controls, that is, whether an operator has the right to access data in the system. Access control only can be set by the system administrator. Setting access control: 1. Open the “Access Control” page using the path: [Setup] → [System] → [Security].

2. If is selected, you must be authorized before accessing the data, and you can configure password policy and LDAP, and change password. If unselected, you can access all the data without authorization, and you cannot configure password policy and LDAP, and change password.

3. If is selected, the administrator can edit privileges for emergency users. If unselected, the administrator cannot edit privileges for emergency users. System Login If access control has been set by the system administrator, you can access data in the system only after logging onto the system. You must log in again after system restart or dormancy.  Logging onto the system: 1. The following dialog box appears:

2. Select the logon type (Local or LDAP), and user name in the drop-down list. 3. Enter the password and click [Logon].  To change users:

1. To log out the current user and change to another user, click in the bottom-left corner of the screen to bring up the following dialog box:

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2. Click [Change User] to bring up the Logon dialog box. 3. Select the logon type, and user name in the drop-down list. 4. Enter the password and click [Logon]  Lock the system

1. Click the in the bottom-left corner of the screen to bring up the dialog box. 2. Select [Lock Machine] and the system is locked. You must log on before using the system. Local Privilege Management The system administrator can add and delete users, and assign privileges, while the operator cannot. The privileges can be assigned through the local system or LDAP server.

Adding a User/ assigning privilege Turn on the access control function and log in to the system as Administrator before you add the user.

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1. Open the “Access Control” page using the path: [Setup] → [System] → [Security]. 2. Click [Add] to bring up the dialog box.

3. Enter the user name and password, confirm password, and select or deselect the check box from the privilege list. Users can only access the function module with assigned privilege. 4. Click [OK] to confirm the setting and exit the dialog box. The new user and the privilege will appear in the User List.

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Deleting a User Turn on the access control function and log in to the system as Administrator before you delete the user. 1. Open the “Access Control” page using the path: [Setup] → [System] → [Security]. 2. Select the user to be deleted in the User List. Click [Delete] to delete the selected user.

Editing privilege Turn on the access control function and log in to the system as Administrator before you edit privileges. 1. Open the “Access Control” page using the path: [Setup] → [System] → [Security]. 2. Select a user, click [Edit Privilege] to enter the "Edit user privilege" dialog box, and select or deselect the check box from the privilege list.

3. Click [OK] to confirm the editing and exit the dialog box. The edited privileges will appear in the User List.

Modify Passwords The system administrator can modify all user passwords. The administrator password is empty by factory default. You can set this password. An operator can only modify his/her own password. There are two ways to modify passwords: on the “Security” page or in the “Manage Session” dialog box.  “Security” page (administrators can modify the password) 1. Open the “Security”” page using the path: [Setup] → [System] → [Security]. 2. Select the user name to be modified in User List. Click [Change Password] to open the dialog box.

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3. Enter the current password, new password and confirm the password, then click [OK].  Manage Session page (general operators and administrators can modify the password). When the user has logged onto the system, is visible in the bottom-left corner of the screen. 1. Click in the bottom-left corner to bring up the Manage Session dialog box where you can see the current user’s information. 2. If you want to modify the current password, click [Change Password] to bring up the Change Password dialog box. 3. Enter both the current and new passwords, and confirm the new password in the dialog box. 4. Click [OK] to exit.

Configure password policy Turn on the access control function and log in to the system as Administrator before you configure the password policy. 1. Open the “Security” page using the path: [Setup] → [System] → [Security]. Click [Password Policy Config]:

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Parameter Description Remark Set the maximum time that a For example, assume user can input the wrong that the "Attempts to Attempts to password. If you exceed the login" is set to 5, the login maximum times, your account "Login duration" is set will be locked. to 60, and the "Lockout period" is Set the duration allowed for a Login set to 60. That is, a user to continuously input the duration user inputs the wrong wrong password. password for 5 times within 60 minutes, the account is locked, and the user can log in to the system only Lockout Set the duration after an after 60 minutes. period account is locked. Other users with unlocked accounts can still log in to the system normally. Reset all Reset all locked accounts. / lockout

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Parameter Description Remark Enable strong password to improve security.  If the strong password is enabled and you log in to the system with the account that is added before the strong password is enabled, the system prompts a warning message to inform you whether your password conforms to the password policy.

Enable strong / password

The administrator can change password for administrator or operator via [Setup] → [System] → [Security].  If the strong password is enabled and you add a new user account, the system prompt an error message to inform you that the password is too weak:

Please modify the password according to the error message.

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LDAP Privilege Management Turn on the access control function and log in to the system as Administrator before you edit privileges for the LDAP (Lightweight Directory Access Protocol) users. 1. Enter [Setup] → [System] → [Security] → [LDAP Config].

2. Enter the server address in the field box after accessing the network. 3. Click [Test LDAP server] to test whether the LDAP server is accessible. If the LDAP is accessible, the system prompts the following message "Server test succeeded." Parameter Description It is automatically displayed after the Root DN server is successfully tested. The default domain is the DC name in the Root DN. For example, if Default Domain DC=security1, then input "security1" in the field box of the "Default Domain"

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Parameter Description Set days to keep the cached passwords in the local system Users can log in to the server even without accessing the network within the setting days. Days to keep cached password  Empty: the passwords are kept in the local system permanently.  0: no passwords are kept in the local system.  >1: for example, if it is set to 5, the passwords are kept in the local system for 5 days.

Adding a user 1. Enter [Setup] → [System] → [Security] → [LDAP Config]. 2. Enter the member name, and select or deselect privileges from the drop-down list of "Privilege". 3. Click [Add], and the new members and privileges will appear in the Member of filter list.

Deleting a user 1. Enter [Setup] → [System] → [Security] → [LDAP Config]. 2. Select a member to be deleted, and click [Delete].

Modifying the member name or privileges 1. Enter [Setup] → [System] → [Security] → [LDAP Config]. 2. Select a member to be modified, modify the member name, and select or deselect privileges from the drop-down list of "Privilege". 3. Click [Modify], and the modified member name and privileges will appear in the Member filter list.

Logon test 1. Enter [Setup] → [System] → [Security] → [LDAP Config]. 2. Enter the User name and password in the field boxes of the Authentication test area. 3. Click [Logon Test] to test whether the user is authenticated. After successful authentication, the system prompt the following message:

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User field name 1. Enter [Setup] → [System] → [Security] → [LDAP Config]. 2. Select [Use user field name] to customize the user field name. After that, the members and privileges cannot be edited. 3. Enter the user field name in the field box of the "User field name" (the user field names are configured in the LDAP server. For details, please refer to the LDAP server manual). User Field Name The user field name corresponding to privileges are as follows:

Privilege User field name archive 20=1 exam/store 21=2 export 22=4 network 23=8 restore 24=16 security 25=32 system 26=64 ultrasound 27=128 worklist 28=256 All 20+21+22+23+24+25+26+27+28=511 Note: the privilege items can be combined randomly. For example, if user A is assigned with all the above 9 privileges, the user field name for user A is 1+2+4+8+16+32+64+128+256=511. Enable Barcode Login This function enables users to log in to the ultrasound system through scanning a barcode that complies with the used-defined regular expression (regex) rule. 1. Select [Enable Barcode Login], enter the user-defined regex in the filed box, and click [OK] to exit the preset page.

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2. In the Logon screen, scan a barcode that complies with the regex rule, and the system automatically enters the LDAP Logon page and display the User Name. After that, enter the password, and you can log in to the system.

Enable Encryption This function enables users to encrypt data that is stored in the hard disk. Note: the remaining space of the cartHD should be greater than 103G; otherwise, encryption is not supported. 1. Enter [Setup] → [System] → [Security]; 2. Enter the password and confirm the password in the field box of the "Exam Data Encryption" area; 3. Click [Enable Encryption], and the following message is displayed "System needs to be restarted after enabling encryption. Are you sure you want to proceed"  If there are exam data in the "Archive" menu, the following message is displayed "Please delete all patient exams to enable encryption." Click [OK] to return to the Security screen. Clear the exam data in the "Archive" menu, and repeat steps 1- 3 again.  If there are exam data in the recycle bin, the following message is displayed "The recycle bin is not empty. Please clear it first." Click [OK] to return to the Security screen. Clear the exam data in the recycle bin, and repeat steps 1-3 again. 4. Click [OK], the system prompts the following message "Encrypting exam data may take about 3 minutes or more. Please wait…" 5. After successful encryption, the system prompts the following message "Encryption succeeded!", click [OK], and an automatic reboot is required.

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8 Patient Information Management

You can start a patient exam in the following situations:  New patient information: to start a new patient exam, patient information must first be entered.  New exam: to start a new exam for patient who is already registered, the recorded information can be obtained through either Archive or Worklist.  Restart an exam: to select an exam that has been completed within 24 hours, continue the exam with imported patient information and exam data.  Resume an exam: to select an exam that has been paused within 24 hours, continue the exam with imported patient information and exam data. General procedure for an exam: Enter the patient informationselect an exam mode and probe Choose an imaging mode Start the exam.  The system supports image scanning and measurement without patient information.

Patient Information To start a new patient exam, it is better to type the detailed patient information. The system will set up a unique information database for each patient based on the patient information entered, so that the information of one patient will not be confused with that of another patient. Before examining a new patient, tap the [End Exam] key on the CAUTION: keyboard to end the exam of the previous patient, update the patient ID and information, to avoid mixing data of the next new patient.  To enter the "Patient Info" screen  Press [New Patient] on the keyboard to enter the patient information page.  To exit the Patient Info screen  Exit and save the settings: tap [OK], or Press [New Patient] on the keyboard.  Exit without saving the information: click [Cancel] on patient information page.  Press or to return to the current exam mode.

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 Click [Quick Register] on the screen to save the patient information quickly and return to the main screen.  The system supports image scan and measurement without patient information. New Patient Information The Patient Info screen is shown as follows:

Place the cursor onto the targeted box. The field box is highlighted and a flashing cursor appears. Information can be entered or selected from the options.

You can also change the cursor position by the key on the keyboard.

Information includes: You can select a desired probe, exam, and preset types from the drop-down list. 1. General information  ID ID is generated automatically by the system after starting a new patient, and can be modified manually. The characters “\”, “\”, “*”, “?” are not permitted. The ID can be obtained by the bar code reader as well.  Name

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Enter patient name through the keyboard.  Gender Select Male, Female or Unknown for patient gender in the drop down list.  Date of Birth

Or, click to select the date and click [OK] to finish.  Age  Auto generated age: once the DOB is obtained, the system can display an auto-generated age in the field box, the unit can be “Years”, “Months” or “Days”. If the age is less than one year, the system will automatically calculate the age in months or days.  Also, you can manually enter the age. NOTE: When you enter the date manually, please enter it in the format as that of the system.

2. Exam Type  Exam Application Type You can select among: ABD (Abdomen), OB (Obstetrics), GYN (Gynecology), CARD (Cardiac), VAS (Vascular), URO (Urology), SMP (Small Part), PED (Pediatrics) and BREAST (Breast). Select the exam type tab to enter the exam-specific information.  General information: Study to enter description for each exam. description: Primary to enter the primary indications (reason to perform indications: the exam.) Secondary to enter the secondary indications. indications: CPT4 code: to enter the CPT4 code. CPT4 to enter the CPT4 description. description: Comment Exam-specific explanation or remarks.  Exam specified information: Exam Type Information Description Height / Weight / Abdomen BSA body After the height and weight are inputted, the system will surface automatically calculate the BSA and BMI (Body Mass area Index) based on the formula.

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Exam Type Information Description ALT Alanine transaminase. Height / Weight / Calculate gestation age (GA) and estimated delivery date (EDD) based on last menstrual period (LMP), in vitro fertilization (IVF), basic body temperature (BBT), previous exam date (PRV). Select LMP, IVF, PRV, BBT, or EDD from the drop-down list; or, calculates GA and LMP according to the EDD and entered date.  LMP: After you enter LMP, the system will calculate and display GA and EDD. Calculation  DOC: After you enter DOC, the system will index calculate the GA and EDD.  IVF: After you enter IVF, the system will calculate GA and EDD.  PRV: input the date and GA of the last exam, the system will calculate a new GA and EDD.  BBT: input BBT, the system will calculate the GA Obstetric and EDD.  EDD: after you enter EDD, the system will calculate and display GA and LMP. Gravida: times of / pregnancy. Gravida: times of Times of abnormal pregnancy. e.g. extrauterine abnormal pregnancy pregnancy. Gestations Number of embryos (1, 2, 3, 4) Para: times of / delivery Abort: times of / abortion Ectopic / GYN Height / (Gynecology) Weight /

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Exam Type Information Description LMP (last menstrual / period) Gravida: times of / pregnancy. Para: times of / delivery Gravida: times of Extrauterine pregnancy abnormal pregnancy. Abort: times of / abortion Ectopic / IVF Essential female hormone and ovulation information Height / Weight / BSA body After the height and weight are inputted, the system will surface automatically calculate the BSA based on the formula. area BP (blood Cardiology / pressure) HR / RA Press (Right / Atrium Pressure) Height / Weight / VAS (Vascular) BP(L) (blood Input left blood pressure. pressure)

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Exam Type Information Description BP(R) (blood Input right blood pressure. pressure) Height / Weight / URO Serum / (Urology) PSA PPSA / coefficient Height / Small Parts Weight / PED Height / (Pediatrics) Weight / Height / Breast Weight /

3. Operating Information  Accession: refers to exam number used in DICOM.  Attd. Phys: Diagnostician: people who is responsible for the exam.  Operator: people who is responsible for images collection and scanning.  Ref. Phys: the people who requires the operator to do the ultrasound operation. Tip: if the name has been entered before, then it can be memorized by the system, you can select it in the drop-down list. 4. Functional key  [Pause Exam]: to pause the current exam due to some special causes or system power off.  [Cancel Exam]: to cancel the current exam. NOTE: The cancelled exam can’t be restored.  [New Patient]: click to clear the current patient information in the patient information screen in order to input new patient information.  [New Exam]: click to clear the current exam information in order to create a new exam for the current patient.  [OK]: click to save the patient data entered and exit the screen.  [Cancel]: click to cancel the patient data entered and exit the screen.

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Retrieve Patient Information A. ARCHIVE The patient data can be accessed via the “Archive” of the system or USB memory device. Keyword search is available to locate certain studies.

Patient data includes basic patient information, exam information, image files and reports. Functions within “Archive” include: search, view, backup, send, restore, delete and export of patient data. 1. To enter Archive screen (the screen is shown as follows):  Press < Archive > on the control panel;  Click [Archive] in the "Patient Info" screen;  Click [Archive] in the Review screen.

2. Select the data source Select the data source in the drop-down list of "Data Source". 3. Input the search condition:  Item: Name, ID, DOB, Exam Date, Exam Type, Study Description, Gender, Operator and Diagnosis (comments in the report), the default one is name; then enter a keyword or select the period in accordance with the Item selected.

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 Select “Find in results”, the system will search the keyword based on the existed searched results.  Select "Teaching Exam", the system will search the exam that is send to teaching exam. 4. Select the desired patient information in the list, and the system pops up the following menu.

Button Description Description Review an Click to enter the Review screen. Image Patient Click to enter the Patient Info screen. Information Review Enter diagnostic report screen. Report Delete Delete the selected record. Exam Backup Click to back up the selected patient record to Exam media supported. Restore Click to import the patient data from an external Exam media. Click to send the selected patient data to external Send Exam device, DICOM storage server, FTP, or printer. Restart an Click to continue an exam that has been finished Exam within 24 hours. Resume an Click to continue an exam that has been paused Exam within 24 hours. Delete TRI Click to delete only the TRI data. data

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 Send Exam

The system supports sending data to external memory devices, print, or DICOM. You can use this function to export the exam data to external devices and then import to PC or restore to the ultrasound system to review the data.

Select the patient record, click [Send Exam] in the menu to send exam data or images of the selected record. And then select a destination.

 For external memory devices (e.g. USB memory devices): a) PC format transfer: JPG/ AVI, BMP/ AVI, TIFF/ AVI. Where a single-frame image is exported as JPG, TIFF or BMP, and the cine file exported as AVI. b) DCM format transfer: DCM (including single-frame DCM and multi-frame DCM). If the file is transferred in DCM format, the user can set the compression mode and the compression ratio. c) Select whether to send image. d) Select whether to export reports and select the report type. e) Select whether to hide patient information.  For DICOM Storage or Print server, select the DICOM Storage or Print server.  Select the printer service according to the printer you choose.  FTP: select an FTP server (network storage server).

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 Backup Exam Select the patient record, click [Backup Exam] in the menu to backup exam data or images of the selected record.

1) Select a destination. 2) Select whether to remove from local HD after Backup: if "Remove Exams" is selected, the patient information and images are removed; if "Remove Images" is selected, only the patient images are removed. 3) Select whether to encrypt selected exam data: input the password and confirm password in the field box, and then click [Backup]. A "Patient.7z" compressed package is backed up to the USB device, and you need to input the password to open the package.

NOTE: 1. If the password is forgotten, you cannot open the backup package. 2. The password cannot be multi-language or Chinese characters. 4) Select whether to hide patient info. 5) Select whether to include TRI data.

Other buttons:  [Restart Exam], [Delete], [Send Exam] are the same as those in the above table.  [New Exam]: Click to enter Patient Info screen, meanwhile, the corresponding patient information is also imported to the new exam. After you edit the patient information in the Patient Info screen, select [OK] to start a new exam.

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 [Select All Exams]/ [Deselect All Exams]: click [Select All Exams] to select all the patient data listed. Then the button changes into [Deselect All Exams], you can cancel all the selections by clicking [Deselect All].  [Exit]: click to exit Archive.

B. WORKLIST/HL7 ENQUIRY Tips: worklist is an optional function. Configure DICOM Basic and DICOM WorkList first. When the DICOM basic package is configured and the Worklist server has been set, click [Worklist] in the "Patient Info" screen to query or import the patient data (For details about Worklist server setting, please refer to the DICOM chapter.) The system supports: DICOM and HL7. Basic Operations: 1. Press [New Patient] on the keyboard to enter the patient information page. 2. Click [WorkList] to enter the WorkList page.

3. Guarantee the data source: after select the service type, select the worklist server from the corresponding server (DICOM and HL7 server). 4. Input the searching condition: a) Input the search condition: • Select “DICOM server”. You can search via patient ID, accession, key words, worklist server or exam date.

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• Select HL7 server. Search via patient ID, patient name. b) Click [Query].Scheduled patients found within the search criteria are displayed in the lower part of the screen. • After the first query, you can perform the second query based on the preview results. The scheduled patients in the list will update in real time. • Enter patient ID, patient name, accession # and exam date, the system affords the result in real-time. • Or select the keyword type, enter the keywords and then click [Query] to search. • To reset the criteria, click [Clear] button. • Click [Clear Cache] to clear the Worklist cached data. 5. Select the desired patient from the list. a) Click [Start Exam], the patient information is imported into the system and then an exam is started. b) Click [Edit Pt Information], the patient information is imported into the "Patient Info" screen and it is opened. After you edit the patient information in the "Patient Info" screen, click [OK] to start a new exam. c) Click [Show Detail] to see details of patient data. 6. Click [Exit] to exit the Worklist.

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9 DICOM/HL7

NOTE: Before using DICOM, please review the ZS3 DICOM conformance statement. This chapter is confined to the preset, connection verification and DICOM services of the DICOM-configured ultrasound machine, not including SCP configurations like PACS/RIS/HIS. The DICOM package is optional, so the description here is only applicable for the system configured with the DICOM package. This system supports the following DICOM functions: Verify Connectivity DICOM Storage DICOM Print DICOM WorkList MPPS (Modality Performed Procedure Step) Storage Commitment Query/Retrieve Structured Report DICOM Medium Storage (DICOMDIR Review) DICOM Task Management Workflows of DICOM Preset and Applications are briefly described as follows: a) DICOM preset (network property, DICOM local preset, server and service preset). b) Verify connectivity. c) Services application. d) DICOM task management. Terms Abbreviations Description DICOM Digital Imaging and Communications in Medicine AE Application Entity MPPS Modality Performed Procedure Step PDU Protocol Data Unit SCU Service Class User (DICOM client) SCP Service Class Provider (DICOM server) SOP Service-Object Pair

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DICOM Preset

NETWORK PRESET Refer to "11 Network" for details.

DICOM LOCAL PRESET 1. Enter the DICOM local preset screen using the path: [Setup] [DICOM]. 2. Enter AE Title, Port and PDU according to the actual situation, then click [Save] to exit the screen. Setting items are described in the following table.

Name Description Modality Select a modality from the drop down list. Station DICOM station name, which is set to "ZS3" by default. Name DICOM Select the log level: Local Off: not to export logs. Log Level Summary: export only cached logs. Detail: export all logs.

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Name Description Assign from In the worklist, search for exams with selected modalities. Modality Worklist Verify TLS Verify the effectiveness of the TLS certificates. Certificates Import TLS Import trusted certificates. Certificates Clear TLS Clear all certificates Certificates AE Title Application Entity title. Communication port, DICOM communication port. The general port Port of DICOM port is 2345 by default. Maximum PDU data package size (not need to change), ranging PDU from 16384 to 65536; if the value is less than 16384 or greater than 65536, the system automatically sets it to the value 32768. Device Name of the device supporting DICOM services. IP Address IP address of the server. You can ping the other machines after you entered the correct IP Ping address. Server Besides, you can select a server in the Device list to ping it. Setting Device List Displays the added device. Set DICOM Provides server settings of DICOM service, for details, please refer Service to the following chapters. Add Click to add server (s) to the Device List. Delete Click to delete the selected server (s) in the device list. Server setting procedure: a) Enter the server device name and IP address; click [Ping] to check the connection. b) Click [Add] to add the server to the device list, and its name and address are displayed in the Device List. Tips:  AE Title should be the same with the SCU AE Title preset in the server (PACS/RIS/HIS), for example, if the AE Title of the server preset in the storage server is Storage, and the AE Title of the accepted SCU is preset as Machine, then in the figure above, the AE Title of Local should be Machine, and the AE Title of storage server should be Storage.  The device name can be random. If the server name entered in the Device field matches that of another Device in the DICOM Device List, the following message will appear, “the server added already exits.” Click [Ok] to enter a different Server/Device name.

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 4001, 6000, 3001, 6555 cannot be set as the port.  IP address should be the address of the remote server.

Service Preset The DICOM Service screen is used to set attributes of Storage, Print, WorkList, MPPS, Storage Commitment, and Query/Retrieve, and HL7 Query. When the system is configured with DICOM basic function module, and installed with DICOM WorkList, MPPS, DICOM structured report, and DICOM query/retrieve modules, the corresponding preset can be found in DICOM Service screen.

STORAGE SERVICE PRESET 1. On the DICOM Service screen, click the [Storage] page tab to enter the Storage page. 2. Select a device from the Device drop down list and enter the corresponding AE Title, port, etc. 3. Click [Add] to add the service to the Service List.

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DICOM storage preset items are described as follows: Name Description After you set the server (s) in DICOM Preset screen, the Device name (s) will appear in the drop-down list, select the name of the storage server. Service Name Default is xxx-Storage, user-changeable. Application Entity title. Here, it should be consistent with AE Title that of the storage server. DICOM communication port, 104 is default. Here, the port Port should be consistent with that of the storage server port. Set the maximum retries (0-9). The default value is 3. If Maximum Retries the DICOM task sending to the server fails, the default retry times is 3. Interval Time(Sec) Interval time. Refers to the amount of time after which the system will Timeout (Sec) stop trying to establish a connection to the service. Transport Layer Security. Select whether to encrypt the TLS data during network transportation. Allow Multiframe If SCP supports this function, select it. Configure Select the compression mode: Compression New RLE (the image is not compressed), Service Mode JPEG (lossy compression for the image). Select the JPEG compression ratio: lossless, low, medium, and high. Compression Ratio The compression ratio is inversely proportional to the image quality (reversed function). Select the color mode. If you choose the mixed or the gray, RLE/JPEG is unavailable. If you choose the mixed or gray setting, RLE/JPEG Color Mode compression mode will not be available. The image uses 24 bits when sending the image from the ultrasound device to the server; it depends on the image when choosing the mix. The image uses 8 bits if the image is captured in color mode or the image has a tint. All images use 8 bits when captured in gray scale. Total Select if the TRI data is sent together with other data. Recall/Raw/Data SR Storage Option To enable or disable sending structured report.

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Name Description Set the storage mode for image and cine file: Parallel file: save the current file, and is ready for the Storage mode storage of the next file. Parallel frame: send the current frame, and is ready for sending the next frame. Select if files of images that are saved in DCM format Transducer through DICOM or DICOMDIR contain transducer serial Tracking number information. Select if to encapsulate PDF format report in DICOM Encapsulated PDF standard. It becomes available if SCP supports the function. Tag Image Note/Tag Object Send the tagged image. Selection Document Add data sending rules. The number in the bracket Rules (x) indicate the number of added rules. Select an attribute, and this attribute will not be sent. For Remove attributes. example, if you select (0018, 1063) Frame Time, and the (x) frame data will not be sent. The number in the bracket indicate the number of selected attributes for removal. Add Add the DICOM service to the service list. Cancel Click to cancel parameter setting. Select an item in the service list, change the parameters Update in the above area, and click [Update] to update the item in the service list. Delete Click to delete the selected service in the service list. Set the default server for the storage service. Default Select an item in the service list, click [Default] and you Service List can see “Y” in the Default column. Click to verify if the two DICOM application entities are Verify normally connected. Exit Click to exit the screen. Tip:  If the server software supports the compression algorithm, select JPEG, RLE. Otherwise, original data should be used (RLE is the default method).  RLE, JPEG are not supported by all SCPs. Refer to the SCP's DICOM CONFORMANCE STATEMENT electronic file to check whether SCP supports it or not. Do not select these compression modes if the storage server does not support them.  Images of PW/M/TVM/TVD mode (B image is not frozen) and images other than PW/M/TVM/TVD mode: if “Max Frame rate” is not “Full” and the actual frame

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rate is larger than the set value, the system will save the image files in a frame rate of the set value, and transfer in a frame rate of B mode.  Images of PW/M/TVM/TVD mode (B image is frozen), the system will save/transfer the images files in frame rate of 6.

PRINT SERVICE PRESET 1. On the DICOM Service screen, click the [Print] page tab to enter the Print page. 2. 2. Select a device from the drop down list and enter the corresponding AE Title, port, etc. 3. Click [Add] to add the service to the Service List.

DICOM print preset items are described as follows: Name Description After you set the server (s) in DICOM Preset screen, the Device name (s) will appear in the drop-down list, select the name of the print server. Configure Service Name Default is xxx-Print, user-changeable. New Application Entity title, here, it should be consistent with that Service AE Title of the print server. DICOM communication port, 104 is default. Here, the port Port should be consistent with that of the print server port.

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Name Description Range: 0-9. Number of retries, if it fails to send DICOM task Maximum Retries to the server. The number of retry attempts can be set here. Interval Time Reserved time. (Sec) Timeout (Sec) Refers to timeout during association establishment. Transport Layer Security. Select whether to encrypt the data TLS during network transportation. Refer to copies of printed files. You can select among 1 Copies through 5, or directly enter the numeral. The system supports RGB (color printing) and Settings MONOCHROME2 (black and white printing). Please select the type the printer supports. Film Orientation Select between LANDSCAPE and PORTRAIT. Priority Specify printing task priority among HIGH, MED and LOW. Select film size among the selections listed in the drop-down Film Size list. Specify quantity of printed files, e.g. STANDARD\2, 3 Display Format indicates 6 images are printed for each page. Specify print medium: Paper, Clear Film, Blue Film; select Medium Type Blue Film or Clear Film for black and white printing; select Paper for color printing. Specify whether you want a trim box to be printed around Trim each image on the film: Yes or No. Configuration Enter configuration information in the field. Print Info Properties Min Density Enter the minimum density of the film. Max Density Enter the maximum density of the film. Specify where the file is exposed: MAGAZINE (stored in the Destination magazine), or, PROCESSOR (exposed in the processor). Select how the printer magnifies an image to fit the film. Replicate: interpolated pixels belong to duplicate of adjacent pixels); Magnification Bilinear: interpolated pixels are generated from bilinear Type interpolations between adjacent pixels; Cubic: interpolated pixels are generated from cubic interpolations between adjacent pixels; None: without interpolation. Add Adds the DICOM service to the service list Cancel Click to cancel parameter preset. Select an item in the service list, change the parameters in Update the above area, and click [Update] to update the item in the service list.

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Name Description Delete Click to delete the selected service in the service list. Service Click to verify if the two DICOM application entities are Verify List normally connected. Exit Click to exit the screen.

WORKLIST SETTING 1. Select [Setup][DICOM][Set DICOM Service][Worklist] to enter the “Worklist” page. 2. Select device in the drop-down list, the available devices are DICOM services already set in the system, enter the information about AE, Title and the port.  Click [Add] to add the service to the Service list;  Select an item in the service list, change the parameters in the above area, and click [Update] to update the item in the service list; click [Cancel] to cancel changing.  Select an item in the service list, and click [Delete] to delete the service.  Select an item in the service list, and click [Default] to set the server to be the default service. 3. Select an item in the service list, and click [Verify] to verify the connection.

DICOM service setting for Worklist is described as follows:

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Name NOTE After you set the server (s) in DICOM Server Setting screen, the name (s) will appear in the Device drop-down list, select the name of the Worklist server. Default is server-Worklist, and it can be Service Name modified. Application Entity title. Here, it is consistent AE Title with that of the Worklist server. DICOM communication port, 104 by default. Port Here, the port should be consistent with that of the Worklist server port. Maximum Retries Reserved feature. Interval Reserved feature. Time(Sec) Refers to time after which the system will stop trying to establish a connection to the service. Timeout (Sec) Value: 5-60s, in increments of 5, and 15 by default. Configure new Transport Layer Security. Select whether to service TLS encrypt the data during network transportation. Scheduled Start Select the query start day from the drop down Date list. Select a date type. Currently, only "Sched. Date Type Proc. Start Date" can be selected. Scheduled Select modalities for query. Modality Scheduled Query the exam with a specified AE title. Station AE Title Count=x A number of selected modalities. Automatic Query Set the automatic query time. Type If select, the system performs automatic Query on Display query after entering the Worklist page. Maximum Entries Set the maximum number of cached entries. Cached Clear Cache Clears cache.

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Name NOTE Click to add the Worklist service to the service Add list. Cancel Click to cancel the parameter setting. Select an item in the service list, change the Update parameters in the above area, and click [Update] to update the item in the service list. Click to delete the selected service in the Delete service list. Set the Worklist server as the default. Default server Select an item in the service list, click Service list [Default] and you can see “Y” in the Default column. Click to verify if the two DICOM application Verify entities are normally connected. Exit Click to exit the screen.

MPPS PRESET 1. Select [Setup][DICOM][DICOM Service Setting][MPPS] to enter the MPPS page. 2. Select the device name, and type the information about the AE title, the port. 3. Click [Add]. The entry will be added in the service list. NOTE: Set the MPPS service as the default when using the MPPS.

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MPPS setting items are described as follows: Name NOTE After you set the server (s) in DICOM Server Setting, Device the name (s) will appear in the drop-down list, select the name of the MPPS server. Service Name Default is server-MPPS, and it can be modified. Application Entity title. Here, it should be consistent AE Title with that of the MPPS server. DICOM communication port, 104 by default. Here, the Configure Port port should be consistent with that of the MPPS new server. service Maximum It starts retrying if it fails to send DICOM task to the Retries server. The retry entry times should be this value. Interval Reserved feature. Time(Sec) Value: 5-60s, in increments of 5, and 15 by default. Timeout (Sec) The connection is disabled if there is no message to be sent in 15 seconds after the MPPS being sent. Add Add the DICOM service to the service list.

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Name NOTE Cancel Click to cancel the parameter setting. Select an item in the service list, change the Update parameters in the above area, and click [Update] to update the item in the service list. Delete Click to delete the selected service in the service list Set the Worklist server as the default. Default Select an item in the service list, click [Default] and Service you can see “Y” in the Default column. list Click to verify if the two DICOM application entities are Verify normally connected. Exit Click to exit the screen.

NOTE: Set the MPPS service as the default when using the MPPS.

STORAGE COMMITMENT SETTING 1. Select [Setup][DICOM][DICOM Service Setting][Storage] to enter the storage page. 2. Select the device name, and type the information about the AE title, the port. 3. Click [Add]. The entry will be added in the service list.

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DICOM storage commitment setting items are described as follows: Name NOTE After you set the server (s) in DICOM Server Setting, Device the name (s) will appear in the drop-down list, select the name of the storage commitment server. Service Name Default is server-SC, and it can be modified. Application Entity title. Here, it should be consistent with AE Title that of the storage commitment server. DICOM communication port, 104 by default. Here, the Port port should be consistent with that of the storage commitment server port. Maximum Reserved feature. Retries Configure Interval new Reserved feature. Time(Sec) service Value: 5-60s, in increments of 5, and 15 by default. Timeout (Sec) After image storage commitment is sent, the system will close the connection with the server. Associated The associated storage server is preset before storage Storage commitment, only after the exam is sent out, can Service storage commitment be created. Add Add the DICOM service to the service list. Cancel Click to cancel the parameter setting. Select an item in the service list, change the Update parameters in the above area, and click [Update] to update the item in the service list. Delete Click to delete the selected service in the service list Default Reserved feature. Service Click to verify if the two DICOM application entities are list Verify normally connected. Exit Click to exit the screen.

NOTE:  Set the related server before performing the storage commitment service.  Save SCP port and the IP on SCP corresponds to the port and the IP on DICOM preset page.

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QUERY/RETRIEVE 1. Select [Setup]DICOM][DICOM Service Setting][Query/ Retrieve] to enter query/retrieve page. 2. Select the device name. The select device is from the DICOM server. Type the information about AE Title and the port.  Click [Add] to add the service to the Service list;  Select an item in the service list, change the parameters in the above area, and click [Update] to update the item in the service list; click [Cancel] to cancel changing.  Select an item in the service list, and click [Delete] to delete the service.  Select an item in the service list, and click [Default] to set the server to be the default service. 3. Select an item in the service list, and click [Verify] to verify the connection.

DICOM query/retrieve setting items are described as follows: Name Description Select the name of a device that can be added Device (including the local). Configure new Service Name Default is server-queryRetrieve, and it can be modified. service Application Entity title. Here, it should be consistent with AE Title that of the storage commitment server.

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Name Description DICOM communication port, 104 by default. Here, the Port port should be consistent with that of the storage commitment server port. Maximum Reserved feature. Retries Interval Time(s) Reserved feature. Value: 5-60s, in increments of 5, and 15 by default. The connection is disabled if there is no image and Timeout information retrieving in 15 seconds after the user receiving the information or the image. Add Add the DICOM service to the service list. Cancel Click to cancel parameter preset. Select an item in the service list, change the Update parameters in the above area, and click [Update] to update the item in the service list. Delete Click to delete the selected service in the service list Click to verify if the two DICOM application entities are Verify normally connected. Service list Set the query/retrieve server as the default. Default Select an item in the service list, click [Default] and you can see “Y” in the Default column. Exit Click to exit the setup screen.

HL7 QUERY SERVICE PRESET HL7 refers to the medical information exchange protocol on the seventh layer (application layer) of the Model of the Open System Interconnection published by ISO. It is established by Health Level Seven International in 1987. HL7 is mainly used for standardizing the communication between HIS/RIS system and the other devices, reducing the information interconnection costs among hospitals, and improving the data usability for hospital information system. The protocol version that the ultrasound system supports: V2.3, V2.4, V2.5, V2.6. 1. Select [Setup][DICOM][DICOM Service Setting][HL7] to enter the page. 2. Select device in the drop-down list, the available devices are services already set in the system, enter the information.  Click [Add] to add the service to the Service list;  Select an item in the service list, change the parameters in the above area, and click [Update] to update the item in the service list; click [Cancel] to cancel changing.

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 Select an item in the service list, and click [Delete] to delete the service.  Select an item in the service list, and click [Default] to set the server to be the default service.

HL7 service setting for Worklist is described as follows: Name NOTE After you set the server (s) in DICOM Server Setting screen, the name (s) will appear in the Device drop-down list, select the name of the Worklist server. Default is server-HL7Query, and it can be Service Name modified. Configure Application Entity title. Here, it should be AE Title New service consistent with that of the HL7 server. DICOM communication port, 104 by default. Port Here, the port should be consistent with that of the HL7 server port. Maximum Retries Reserved feature. Interval Time(Sec) Reserved feature.

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Name NOTE Refers to time after which the system will stop trying to establish a connection to the service. Timeout (Sec) Value: 5-60s, in increments of 5, and 15 by default. This function enables the ultrasound system to Listen Mode use the listen port for data receiving. Port for ultrasound system to receive data after the listen mode function is activated. Here, the port should be consistent with that of the Listen Port Worklist server port. For details of listen port setting, refer to settings in the server. Click to add the Worklist service to the service Add list. Cancel Click to cancel the parameter setting. Select an item in the service list, change the Update parameters in the above area, and click [Update] to update the item in the service list. Click to delete the selected service in the Delete service list. Service list Select an item in the service list, click [Default] Default and you can see “Y” in the Default column.

OTHERS You can configure different type of DICOM services in different scenarios.

DICOM Verifying To verify connectivity (not essential), click the [Verify] button on the Storage, Print, Worklist, MPPS, Storage Commitment and Query/Retrievepages respectively. If the verification is successful, the system displays “xxx Verification Succeed.” Otherwise, it displays “xxx Verification Failed.” If verification failed, possible causes may be: wrong IP address; not able to access IP address; remote DICOM server is not running; wrong port; incorrect application (AE) Title.

Tip: Not all SCPs can support verification. See the SCP properties to confirm whether the SCP can support this service. If not, the verification will not be successful.

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DICOM Services If all the DICOM presets on the DICOM Service Preset screen are completed, you are ready for the Storage, Print, Worklist (HL7 Query), MPPS, Storage Commitment and Query/Retrieve applications.

DICOM STORAGE DICOM Storage is used to send images (single-frame or multi-frame) or structured report to the DICOM storage server for storage. Follow the procedures below when setting DICOM storage.

Send images on Archive/Review/main screens (Thumbnail area) (1) Select images  Press to enter the Archive page. Click on a patient or an exam record in the list to select it. Thumbnails are displayed in the thumbnail area in the lower part of the screen, and then click to select a thumbnail or the cine. Or, select an exam or exams from the patient list (there should be images for this exam).  Press to enter the Review screen. Click to select a thumbnail or the cine. (press the left or right key to choose more).  On the main screen, select a thumbnail or the cine. (2) Click in the top-right part or [Send Exam] to bring up the following dialog box.

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(3) Click to select “DICOM” in the Target box on the left side, then select the DICOM storage server in the Storage Server box on the right side, and click [OK]. To send images using a shortcut key You can save single-frame images or multi-frame images to a DICOM server while saving to hard drive using a shortcut key. The procedure is as follows: (1) Define the key (Store 1/Store 2/Print) in [Setup]->[Keys]->[Image Store/Print Buttons]. (2) Set a default storage server: a) Enter the DICOM Service Preset screen via “[Setup][DICOM]  [Set DICOM Service].” b) Select a storage server in the Service List and click [Default]. You will see “Y” marked in the Default column. c) Click [Exit] to exit the page and return to the Setup menu, then click [Save] on the Setup menu to make the preset take effect. (3) Press the key to send the image or the cine to DICOM storage. To send images to storage after an exam ends (1) Enter [Setup]->[Keys]->[Image Store/Print Buttons] and then Set the Image Transfer Mode to "End Exam". (2) Enter DICOM preset page. Click “Storage” to preset the default storage server. (3) Start the ultrasound exam scan. Click [End Exam] to send the image or the cine to DICOM storage automatically. To send images to storage when the exam is in progress (4) Enter [Setup]->[Keys]->[Image Store/Print Buttons] and then Set the Image Transfer Mode to "Exam In Progress". (5) Enter DICOM preset page. Click “Storage” to preset the default storage server. (6) Start the ultrasound exam scan. Click the user-defined key for capturing an image or cine to send the image or the cine to DICOM storage automatically. Structured Report (SR) The system supports OB/GYN structured report, Cardiac structured report, Breast Structured Report, and Vascular structured report, and for OB, GYN, Vascular, Breast, and Cardiac exams, structured report functions are contained in DICOM storage, DICOM storage commitment and DICOM media storage. The SR can be sent with meeting the following procedures:  DICOM structured report option is installed with the corresponding exam mode;  The exam mode is: abdomen, OB, GYN, cardiac, vessel and breast;  Sending in the unit of single exam;  It is unable to send the SR if the state is Cancel or Stop.  Set the storage option to Attach When Store Images, or Only Store SR. Send OB/GYN/Cardiac/Breast/Vessel SR on Archive.

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1. Choose the storage option to Attach When Store Images, or Only Store SR. 2. Create new patient information or load the patient information. 3. Perform obstetric (gynecology, cardiac, breast or vascular) measurements: 4. Save the image or the cine. 5. End an exam 6. Click [Send Exam] on Archive page. The following figure appears:

7. Select DICOM in the storage server list, select a server in the “Storage Server” list. 8. Click [OK], the status of sending task can be viewed in DICOM task management. After successful storage of both image and structured report; you can see the storage commitment mark “√” in the list below in the Archive screen. Encapsulate PDF Encapsulate PDF refers to the PDF file is encapsulated in DICOM IOD. Encapsulated PDF is sent by following the procedures below:  Send in the unit of single exam;  The exam with the state of End, Cancel or Stop cannot be sent as encapsulated PDF.  Check “Encapsulate PDF” in the storage service preset;

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 If there is an exam result in the report template, this type of exam should be performed. Sending the exam or archiving the exam can send the encapsulated PDF file. Unload DCM file The image can be unloaded to DCM format and send to the FTP server. 1. Select the image, and click to enter the page. 2. Select “Target”-“FTP” to export the image in DCM format. See the figure below:

3. Click [OK] to send DCM format file to the external media.

DICOM PRINT DICOM Print is used to send images to the DICOM print server for printing. Perform the following procedures after configuring DICOM print. Print images on Archive/Review/main screens (Thumbnail area) 1. Select the image, the cine and the exam and send them. Operations are the same as for DICOM storage. 2. In the Send To dialog box, select a DICOM print server. (For the dialog box, see DICOM Storage). 3. Click [OK] to send the image and begin printing.

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To send images using a shortcut key You can send single-frame images to a DICOM print server while saving to hard drive using a shortcut key. 1. Define the key (Store 1/Store 2/Print) in [Setup]->[Keys]->[Image Store/Print Buttons]. 2. Set a default printer server. 3. Press the shortcut key to send the image to the hard disk; the system also sends the single-frame file to the printer server. To print images for storage after an exam ends (1) Enter [Setup]->[Keys]->[Image Store/Print Buttons] and then Set the Image Transfer Mode to "End Exam". (2) Set a default print server. (3) Start the scan and obtain the image. Each time is pressed, the system will send the image to the default DICOM print server for printing. To print images for storage when the exam is in progress (1) Enter [Setup]->[Keys]->[Image Store/Print Buttons] and then Set the Image Transfer Mode to "Exam In Progress". (2) Set a default print server. (3) Start the ultrasound exam scan. Click the user-defined key for capturing an image or cine to send the image or the cine to the default DICOM print server for printing.

DICOM WORKLIST/HL7 QUERY For details, refer to "WorkList/HL7 Enquiry".

MPPS MPPS is used to send exam state information to the configured server. This facilitates the other systems in obtaining the exam progress in time. After you preset the Worklist server and MPPS server, if the system obtains the patient information from Worklist server to begin the exam, it will send exam status information to MPPS server of when the exam is undergoing or ended. If the sending fails, the system resend automatically.

STORAGE COMMITMENT Storage commitment is used to confirm whether the images or structured reports are successfully stored on the DICOM storage server. Before using storage commitment, set the associated storage service. Storage commitment after sending images on the Archive screen. 1. Select the image, the cine or the data, and send it. 2. Click to select “DICOM” in the Target box on the left side, and then select the DICOM storage server in the Storage Server box on the right side.

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3. Click [OK] to start sending. The system will send all the images stored in the exam record to the storage server. Meanwhile, it will send storage commitment to the storage commitment server.

QUERY/RETRIEVE The query/retrieve function is used to query and retrieve patient exam records in a designated server. After setting the DICOM query/retrieve server, you can perform the query/retrieve function in the Archive screen. a) Open the Archive screen: press on the control panel. b) Click [Query/Retrieve] to open the screen.

c) Select the server in the “Server and Service” area (both the source and the destination). d) Enter the query information, such as Patient ID, Patient Name, Accession #, Exam Date or key words. Click [Clear] to empty the entered query information. e) Click [Query]. The system performs the query and lists the results in the patient (source) list. You can perform further queries based on the results by entering new query information. f) Select one or more patient records according to the actual situation.

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Click [Select All] to select all the patient records in the list. Click [Deselect All] to deselect all the patient records in the list. g) Click [Retrieve] to retrieve the patient records in the DICOM query/retrieve server to the local machine. h) Click [Exit]. The retrieved patient records are listed in the Archive screen. DICOM Media Storage Patient data in the ultrasound system can be saved on external media in DCM format, while DCM files can be accessed in the ultrasound system. DICOM media storage and DICOMDUR review should meet the following conditions:  There is a DVD disk in the ultrasound device, and it works well.  File system format of CD/ DVD optical file should be ISO9660, and the optical disk should not be damaged.  File system format of DVD optical file should be UDF, and the optical disk should not be damaged.  Normally read/write data from the USB ports on the ultrasound system  File system format of removable device (USB flash drive) is FAT32 and the media should not be damaged. Media Storage 1. Select patient records in the Archive screen. 2. Click [Send Exam] in the menu which appears to open the dialog box.

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3. Select the destination to “DICOM Media” and DICOM compression mode. You can select to delete the exam or the image after the backup. 4. Click [OK]. The image from the current exam is sent to the media in DICOM format. If the backup is successful, a tick will appear in the Backup list in the Archive screen. If not, there will be no tick. There must be no DICOMDIR/DCMIMG/IHE_PDI files on the external storage media of the same name as the one being backed up. Otherwise, the backup cannot proceed. Ensure there is enough storage space, or the backup may fail due to shortage of space. Media review 1. Connect the external media with DCM files to the system. 2. Select the data source in Archive screen, and the visible data will be shown. If there are several types of data on the media, the system will ask you to select the format. Then, click [DICOMDIR].

Data Restore After the DICOM format data are saved to external media, restore the data to the ultrasound system. 1. Connect the external media containing DCM files to the system. 2. In Archive, review the data stored on the external media. 3. Select the data to be restored in Archive.

4. Click on the Archive screen. NOTE: Only system-accessible media can be selected.

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10 Peripheral

Print Service This screen is used to set up the printer and image printing. Enter [Setup]->[Peripheral]->[Print Service] in the preset menu to enter.  Printer setting The printer settings include print service and print driver.

 Print Service Setting  Add Service: click to begin adding print services (only digital image print can be added).  Remove Service: click to delete the selected print service (only digital image print can be deleted).  Rename Service: click to rename the selected print service.  Default print service: click to set the selected print service as the default one.  Property: to preset print service properties.

 Send images to a printer using shortcut keys

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Enter [Setup]->[Keys]->[Image Store/Print Buttons] and then select an appropriate printer service from the drop down list of the Network/USB Printer for the Store1, Store2, and Print buttons. Barcode Reader Configuration Enter [Setup]->[Peripheral]->[Barcode Reader Configuration]

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Name Description Pos indicates the section sequence number of a 2D barcode. For example: Assume that the 2D barcode is composed of 3 sections: Smith, 123456, and Male in order, and the separator is semicolon ";". 1. Set [Multiple] as the default item and input semicolon ";" as the separator in the field box of [Matching Filter]. 2. Input "1" in the field box of "Patient Last Name", "2" in "Patient ID" and "3" in "Patient Gender" under the Pos column. Pos 3. Scan a 2D barcode. 4. The system begins analyzing the barcode and prompt the following message: "Start new exam or update current exam with barcode value?" If you select "New", a new exam is created; if you select "Update", the barcode information is assigned to corresponding items automatically in the Patient Information page. Assume that you select [Update]. 5. The system assigns the first section "Smith" to the field box of "Patient Last Name", second section "123456" to "Patient ID", and third section "Male" to "Patient Gender" under the Pos column. Field Matching item in the Patient Information page. For 2D barcode, if the default field is set to "Multiple", the system will analyze a barcode according to the matching filter setting (regular expression or separator) in the multiple item. For 1D barcode, if the default field is set to any item from "Patient ID" to "Attending Physician". The system will analyze a barcode according to the matching filter setting (regular expression or separator) in the default item. For example, if you select "Patient ID" as the default field, and Default the barcodes fails to be matched after matching the field in the priority order "Patient ID" -> "Patient Last Name" -> "Patient First Name" -> "Patient Gender" -> "Patient DOB" -> "Accession Number" -> "Operator ID" -> "Attending Physician", the obtained data is displayed in the "Patient ID" field. If the default field is set to "None", and the barcode fails to be matched, the obtained data of the barcode is input as a string of characters in the field where the cursor lies. Set the regular expression or wildcard character according Matching filter to the bar code format. Set whether to filter the obtained data by regular Regex expression.

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Name Description Operator ID or Attending Physician can be appended after being checked. For example, after scanning a 1D barcode of an Operator ID or Attending Physician, the obtained data is A, and A will be displayed in the "Operator ID" or “Attending Append Physician” field in Patient page automatically. After scanning a 1D barcode of an Operator ID or Attending Physician for a second time, the obtained data is B, and A will be appended by B in the "Operator ID" or "Attending Physician" field in Patient page automatically. None: create a new exam according to the analyzed barcode. Worklist Cache (if available): create a new exam according Barcode to the analyzed barcode that is matched with the exam in Worklist options the Worklist cache. Worklist Server (if available): create a new exam according to the analyzed barcode that is matched with the exam in the Worklist server. 1. Select a default item for searching the Worklist server. For example, users select "Patient ID" from the drop down list, and the system searches Patient ID in the Worklist Default server. 2. Select "None", and the system searches the Worklist server in the priority order: "Patient ID" -> "Patient Last name" -> "Accession Number". Barcode Select an appropriate Barcode Reader Device. Reader Device None: the barcode is input as a string of characters. Assignment

Power Save Enter [Setup]->[Peripheral]->[Power Save]

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The two different categories of power operation mode configurations in this menu are:

Title Definition Cart Battery Configuration of power saving action when the system is being operated without AC power applied. System will be running off the ZS3’s internal Z-PAK battery. External Power Configuration of power saving action when the system is running off AC wall power.

The two configurable Power Save behaviors offered are: Title Function Sleep when idle for Screen display is “Blanked”, after configured time period has elapsed (range: 1-60 minutes) Shutdown when idle System performs a complete sequenced “Power-Down” for operation, after configured time period has elapsed (range: 1-120 minutes)

For each of the power configurations, select the desired power saving option, and enter the desired time interval, from the menu. NOTE: Unchecking the “Enabled” box, for either option, disables that time-out function.

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11 Network

Network Setup The “NETWORK” configuration menu allows for configuring the TCP/IP networking parameters that will be assigned to define the identity of the system on the hospital’s network. 1. Enters [Setup]-> [Network] -> [TCP/IP].

Using an alpha-numeric keyboard, enter in the required TCP/IP network configuration values/settings in the appropriate fields, as specified in the information previously provided in the “Pre-Installation Site Survey Form”, by the medical facility’s IT System Administrator.

Move the cursor using the trackball to highlight SAVE and press one of the SET keys to save the Network configuration setup, and exit.

Wireless Network Equipment - Setup Mindray/Zonare supports wireless connectivity using the Quatech (brand) AirborneDirect (model) Wireless Ethernet Bridge (supported model is the ABDN-ER-

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DP551U. This is a plug-and-play wireless networking solution that is compatible with all Mindray/Zonare ultrasound systems that support Ethernet connectivity. A special power cable, however, is required to supply power to the Quatech AirborneDirect device from a USB port on the Mindray/Zonare system, for portable operations.

The Quatech AirborneDirect Wireless Ethernet Bridge supports WiFi 802.11b/g/n wireless standards and connects to the Mindray/Zonare system through a 10 Base-T network interface. This device supports WEP (64/128 bit) and WPA encryption standards, PEAP and LEAP for network authentication (LEAP requires that Quatech device be configured with a static 128 bit key; this is known as "migration mode" and is not recommended for long term use due to the static WEP key requirement). Before using it with the Mindray/Zonare system, the Quatech AirborneDirect device must be preconfigured for the user's networking environment – SSID, channel, encryption, and correct addressing scheme (DHCP/static).

Static IP addressing is required in order to be able to display the additional wireless status. When power is applied to a correctly configured Quatech AirborneDirect device that is connected to the Ethernet port on the Mindray/Zonare system, it will require 30 to 60 seconds to detect and then associate with the user's wireless network. Once a wireless network connection is established, the Mindray/Zonare system will reflect the connection state by showing the network ICON on screen, in an uncrossed state.

The configuration of the Wireless Bridge is done on the Network configuration screen. The source information required for wireless device configuration on the ZS3, is the static IP Address assigned (by the IT Administrator at the install site) to the Quatech AirborneDirect device and the Username and Password for the CLI interface (default is dpac for both).

For assistance with the configuration of the local network settings on the ZS3, to support that aspect of a wireless network installation, contact Mindray/Zonare Technical Support.

 Wireless bridge settings 1. Connect the Airborne Direct wireless bridge to the network port and the power cable to the USB port of the ultrasound system for the configuration and ensure the power has been connected to it. 2. Enters [Setup]  [Network]  [TCP/IP].

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3. Select "Use Specified", enter 192.168.2.10 (exclude 192.168.2.100), 192.168.2.1 in the "Gateway IP Address", and 255.255.255.0 in the "Subnet Mask". As shown in the above figure. 4. Click [Save] to save the configuration. 5. Enter [Setup] [Network]  [TCP/IP] again. 6. Click [Logon] to enter the "Wireless Login Configuration" page:

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7. Enter dpac to the field of both the User Name and Password, and then enter 192.168.2.100 to the field of IP Address. Note: the IP address for Bridge is 192.168.2.100, and 192.168.2.1 for Router. 8. Click [OK] and the system prompt the following page:

9. Wait for a few minutes until the "Configure Wireless" and "Reset Password" buttons are highlighted. 10. Click [Configure Wireless] to enter the "Wireless Login Configuration" page.

11. Enter dpac to the field of both the User Name and Password again, and click [OK] to enter the "Wireless Configuration" page, as shown in the following figure:

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12. Enter the wireless parameters assigned by the IT department. 13. Click [OK] to save the parameter configuration. 14. In the TCP/IP page, select "Obtain Automatically (use DHCP)", and click [Save] to exit the preset page. 15. After successful connection, a wireless network icon is displayed at the bottom left corner of the screen.

 Indicator illustration

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FTP Setup Enters [Setup] [Network]  [FTP].

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1. Enter the required FTP configuration values in the fields of Service Name/IP Address/Port/User Name/Password. Parameters specified in the above figure are given as an example. 2. Select [Active] of the Data Transfer Mode. 3. Click [Add], and the FTP Service is displayed in the Service list. 4. Click [Ping]. Until successful ping, the message "Connection succeeded!" is displayed. 5. Click [Update] to update modified configuration values, and click [Delete] to delete the selected FTP Service. 6. Click [Save] to exit.

QPath/QView You can use the ultrasound system to check data on browser directly. After you have ordered storage service of a network website service, you can check data using the website, authorized account and password (provided by the service vendor).You can open the browser to review previously sent DICOM data. 1. Enters [Setup]  [Network]  [QPath/QView].

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The preset procedures are as follows: 1. Select [Enable Q-Path]. 2. Enter the server address in the field box of "Server Address". 3. Select an appropriate item from the drop-down list of "Category" 4. Select an exam mode in the left "Exam Mode" column. 5. Select a worksheet in the right "Worksheets" column. 6. Click [Save] to exit, and the system will shut down.

Parameter Description Sets the sub URLs of "QView full" and "QView lite". Advanced The sub URL is set by default. Users can modify the sub URL and click [Save] to exit the "QView sub URL setting" window. Initial connecting Sets to 30 by default. time out (secs)

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Parameter Description Accelerated Accelerates the movement speed of the trackball. Trackball Move Enable Direct Sets whether to open the Q-Path server through pressing Report the key. Sets whether to directly enter the Worksheet interface Worksheet Only after opening the Q-Path server. Sets whether to display the Signature field box in a worksheet. Press →[WorkSheet] or press → Password On End [Report] → [WorkSheet], enter the worksheet password in Worksheet the field box, and click [OK]. Users can query the corresponding worksheet by searching the worksheet password in the Q-Path server. Password On End Sets whether to input the worksheet password after Exam ending an exam. Password Visible Sets whether the password is visible. Imports a user-defined worksheet template from the USB Import storage (downloaded from the Q-Path server). Backup Backs up worksheets to the USB storage. Restores the backup worksheet template from the USB Restore storage to the ultrasound system. Delete Deletes a worksheet template. Restore Factory Restores the worksheet template to the default state.

VPN 1. Enter [Setup]  [Network]  [VPN].

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2. Enter the server IP in the field box, and click [Test IP] to test the IP address. After successful test, the system prompts the following message "Successfully passed VPN server IP test", and the [LogOn] button is highlighted.

3. Select a group from the drop-down list of "Select Group", enter the user name and password, and click [LogOn]. After successful connection, the system prompt the following message "Successfully connected VPN server", and the VPN Status becomes "Connected".

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12 Functional Descriptions

System Capabilities

• 64-hardware - 128/192-synthetic channel system • Supports B-Mode, M-Mode, Color, Power Doppler, PW, ARFI • 19” full-screen, 1280 x 1024 resolution, Display • Full-sized alpha-numeric user keyboard • Discrete function user controls • Software mode assignable user controls • User programmable keys • Integrated stereo speakers (located in display) • External I/O device connectivity o Ethernet 10/100Base-T o eSata/USB Connector o USB port o HDMI Connector • Internal solid-state drive (image archive) • On-board Z-Pack Battery Module (Option)

Major FRUs

MODULE • P/N 115-051402-00 ZS3 Module Kit(ARFI,Without ECG/9.x) • P/N 115-051400-00 ZS3 Module Kit(ARFI,Aux-ECG/9.x)

Figure 12.1-ZS3

DOCK BOARD WITH CART SSD & CHASIS, P/N: 115-029533-00 • 115-029534-00 Dock Board(FRU) • 115-029532-00 SSD 128G 2.5"(FRU)

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Figure 12.2-ZS3

CART BASE WITH CASTERS, P/N: 115-045914-00 • 115-031746-00 150mm total locking castor • 115-031572-00 150mm direction locking castor

Figure 12.3-ZS3

POWER MODULE ASSY, ZS3 P/N: 115-052756-00 • VCart (power for module), +12V • VDock (Monitor, UI, Printer), +12V • Z-PAK battery charging circuitry • Z-PAK battery fuel gauge • PIC Power Supply Controller logic • External system status LEDs (7)

Figure 12.4-ZS3

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UI-ZS3 NEW-PORT (FRU/9.X) P/N: 115-066353-00 (115-066352-00UI ZS3- SP NEW-PORT (FRU)) • QWERTY keyboard • OLED soft-function displays • Trackball assembly • DGC controls • Discrete functional controls

Figure 12.5-ZS3

DISPLAY, ZS3 P/N: 115-035481-00 • System display • Speakers • Internal MIC

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Figure 12.6-ZS3

DISPLAY SUPPORT ARM KIT, ZS3 P/N: 115-046667-00 • 034-000428-00 19"Display Support arm

Figure 12.7-ZS3

BATTERY KIT, P/N: 115-075674-00

Figure 12.8-ZS3

BRAKE MECHANISM - CASTER The system has 4 casters in 2 different types: 3 total locking casters (the left black one as shown in the following figure) and 1 direction locking caster (the right green one as shown in the following figure).

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Figure 12.9-ZS3  For direction locking caster: when you use your foot to push down the lower black pedal under the upper green pedal, the direction locking caster is locked and the system can be moved only forward. When you use your foot to push down the upper green pedal, the direction locking caster is released from brake and the system can be moved in any direction.  For total locking caster: when you use your foot to push down the lower black pedal, the total locking caster is locked and the system cannot be moved. When you use your foot to push down the upper black pedal, the total locking caster is released from brake and the system can be moved.

HEIGHT ADJUSTMENT MECHANISM The system utilizes a gas spring mechanism that enables the user to optimize the vertical position (height) of the user interface panel and LCD Display for optimum comfort and viewing during operation. To raise or lower the unit, pull inward on the release lever, located on the inside of the right-front handle assembly on the system. This will allow the height of the system to be adjusted. Releasing the lever locks the assembly into the current vertical position.

Figure 12.10-ZS3: Height Adjustment Mechanism

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13 System Diagrams

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Power Block Diagram

Figure 13.1-ZS3: Power Block Diagram ZS3 Service Manual Page 134 of 296

Cabling Diagram

Figure 13.2-ZS3: Cabling Diagram

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System Block Diagram

Figure 13.3-ZS3: Overall System Block Diagram

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14 Peripherals & Accessories

Black & White Printer

The procedure provides instructions to install and setup the UP-D711MD, Sony UP-D897MD, and Sony UP-D898MD_X898MD Black and White printer on the ZS3 system

Figure 14.1-ZS3

Prior to beginning the initial mounting/installation, ensure the system is powered-down (Backlight for power On/Off button should be dark).

UNPACKING AND MOUNTING INSTRUCTIONS 1. Remove the printer and all installation hardware from their packaging. 2. Drop telescoping cover to find preinstalled printer power and USB cables. Cut cable-tie to release their free ends and route them forward, and use the cable ties to fix the ultrasound gel warmer to the original place. Restore telescoping cover.

Cable of the ultrasound gel

Figure 14.2-ZS3

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3. Use a Philips screwdriver to install the four (4) 33104-00 screws that attach the printer/bracket assembly to the user interface base.

Figure 14.2-ZS3: Printer Bracket Mounting to ZS3 Cart

4. NOTE: The printer comes out of the box with M3 Phillips head screws installed in its threaded mounting holes, as placeholders or thread protectors. These screws need to be removed before sliding the printer into the bracket. Place printer into bracket and slide back toward cart column leaving the power and USB connections on right side exposed. Connect USB cable to printer. Connect power cable to printer.

Figure 14.3-ZS3: Cable Connections (UP-D711)

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5. Slide printer forward to its mounting position in the bracket. (Mounting holes in bracket will align with threaded holes in bottom of printer – in centers of round pads.

Figure 14.4-ZS3 6. Using a Philips screwdriver, install the four (4) 33215-00 flat head screws (provided in the kit), through the holes in the mounting bracket and into the four threaded holes in the printer, as shown below.

Figure 14.5-ZS3 7. Place the printer cables inside the printer bracket and secure with the cable-tie (30133), as shown below

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Figure 14.6-ZS3

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Operator Controls

Figure 14.7-ZS3: Operator Controls (UP-D711)

1. Power ON/OFF Switch 2. Printer Lamp – Lights while printing 3. Feed Button – Hold down to feed paper. The paper will only advance while the button is pressed. 4. Paper Lamp – Lights when tray is empty or paper not aligned correctly. 5. Alarm Lamp – Lights when door is open or problem with printer. 6. Open Button – Press to open door or press and hold to open all the way. 7. Printer door w/teeth - cuts paper after image is printed.

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Setup Procedure

1. Connect the USB cable with the symbol facing up into the back of the printer. 2. Connect the DC power cable in to the back of the printer.

3. Secure the cables to the printer bracket with the zip tie PN: 30133 (as shown)

Figure 14.8-ZS3 4. Power-On the system.

5. Turn the printer on by pressing the button. 6. Press and hold the Open button to extend the paper tray.

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7. Place the paper roll into the tray and make sure the paper extends out through the opening.

.

8. Make sure the paper is set straight. High gloss paper is recommended for optimum quality print.

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9. Close the door and press until it locks.

Setup Procedure For details about printer settings, please refer to "Print Service".

Print verification: 1. Power on the system, the printer, and connect a transducer.

2. FREEZE the image. Verify a printed image is produced when the “Print” key is depressed.

NOTE: Refer to the SONY UP-D711MD Operators Manual, for detailed information on proper operation of this device.

Color Printer

INSTALLATION NOTES: SPECIAL NOTE The Sony UP-D25MD Color Printer is oversize and is therefore not a peripheral that can be “mounted” on ZS3 system. A separate external location (rolling cart, tabletop, etc) must be made available for storage of this printer. The system software on the ZS3 system contains the necessary drivers to support operation and printing to the Sony UP-D23MD and UP-D25MD Color Printers. The information provided below covers the basic menu setup, to enable printing to this device.

SETUP PROCEDURE: 1. Identify the dedicated work area, within reach of the system, for placement of the Sony UP-D25MD printer and setup the printer in that location. 2. Power off the system.

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3. Connect the B cable from the Sony UP-D25MD Color Printer to one of the USB ports on the rear of the system 4. Connect the AC power cable to the rear panel power receptor of the UP- D25MD labeled “AC IN.” 5. Apply power to the system and printer. 6. Under the SETUP -> PERIPHERAL-> PRINT SERVICE page, create a new “Local/USB” type printer entry for the Sony UP-25MD printer 7. Enter “Sony UP-D25MD” in the Nick Name field of the printer configuration page. 8. Select the desired printer settings, from those offered in the on-screen menu, and then select “Save” to save the settings. 9. Under SETUP -> KEYS -> IMAGE STORE/PRINT BUTTONS, configure the

“Print” button for triggering a print to the Sony UP-D25MD printer. Check the “Network/USB Printer” box in the Print section then select Sony UP-D25MD from the drop down menu. 10. Connect a transducer to the system. Wait for startup to complete and image to be shown. 11. Press the “FREEZE” key to capture an ultrasound image.

12. Verify a printed image is produced on the UP-D25MD when the “Print” key on the user interface is depressed.

NOTE: Refer to the SONY UP-D25MD Installation Procedure (P/N S00119), or Operator Manual from SONY, for detailed information on proper operation of this device.

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Pedal Footswitch

A remote 2-pedal footswitch is available for purchase as an option for use with the ZS3 system. It connects to the system via any available USB port. The left and right pedals may be individually configured to one of forty-four possibilities including Print and freeze. The two normal user interface buttons/functions used for the optional footswitch control; are as follows:

o Print

o Freeze Ultrasound Gel Warmer

For newly installed gel warmer: Required Tools: Phillips screw driver 1. Drop telescoping cover to paste 70-80mm length of PVC electric insulation tape on the edge of the Stem weldment.

PVC electric insulation tape

Figure 14.9-ZS3 2. Use a screwdriver to install the 1 Pan head screw M4X12 that attaches the Gel warmer cable to the Stem weldment

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Pan head screw M4X12

Gel warmer cable

Figure 14.10-ZS3 3. Remove the eight(8) screws underneath the UI and disconnect and remove the UI, thread the Gel warmer cable through the punch hole of UI interface base and connect 4-pin connector side into the rightmost port of the power distribution strip

Remove the eight (8) screws and the UI

Figure 14.11-ZS3

Gel warmer cable connect port

1

Figure 14.12-ZS3

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4. Wind a circle and tie the tail of the Gel Warmer cable and printer USB cable.

Wind a circle and Tie the tail of the Gel Warmer cable and printer USB cable

Figure 14.13-ZS3 Notes: Screw tightening torque: M4: 6-7 kgf.cm

For upgrade gel warmer Required Tools: Phillips Screw Driver Auxiliary material: Cable Tie, PVC electric insulation tape 1. Drop telescoping cover to find preinstalled printer power and USB cables. Cut cable- tie to release connector ends and route them forward.

Cut cable tie

Figure 14.14-ZS3 2. Paste 70-80mm length of PVC electric insulation tape on the edge of the Stem weldment

Paste PVC tape

Figure 14.15-ZS3 3. Use a screwdriver to install the 1 Pan head screw M4X12 that attach the Gel warmer

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cable to the Stem weldment

Pan head screw M4X12

Gel Warmer cable

Figure 14.16-ZS3

Printer power cable

Gel Warmer cable

Figure 14.17-ZS3 4. Connect Gel power cable to printer power cable. Push them back to the inside of UI interface base. wind a circle and Tie the tail of the Gel Warmer cable and printer USB cable (If there’s no printer installed)

Wind a circle and Tie the Push back into tail of the Gel Warmer the inside of UI cable and printer USB cable (If there’s no printer installed)

Figure 14.18-ZS3

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For newly installed gel warmer holder Required Tools: Phillips screw driver 1. Buckle the upper bracket of Gel warmer into the left side of the user interface base. Upper bracket of Gel warmer

Figure 14.19-ZS3 2. Aligning with the rib of the upper bracket, assemble the bracket cushion onto the upper bracket. Bracket cushion

Align with the rib

Figure 14.20-ZS3 3. Screw the lower bracket into the upper bracket till the marks aligned. (Fig.5C, 5D)

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Punch hole of Gel warmer cable

Lower bracket

Figure 14.21-ZS3

Marks aligned

Figure 14.22-ZS3 4. Thread the Gel warmer cable through the punch hole of the lower bracket, buckle the Gel warmer downward. (Fig.5E, 5F)

Gel warmer

Figure 14.23-ZS3

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Figure 14.24-ZS3 For upgrade gel warmer holder Auxiliary material: Cable Tie, and PVC electric insulation tape 1. Tie Gel warmer cable together with Monitor power cable on front of the Stem weldment. Replace telescoping cover. If printer is optional, tie printer power cable and printer USB cable. Replace telescoping cover

Cut cable tie Cut cable tie

Figure 14.25-ZS3 2. Thread Gel warmer cable through UI hole and connect it to Gel warmer. Use cable tie to fix the Gel warmer cable to cable hanger. Notes: cable tie needs to thread through the mounting hole in connector of Gel warmer cable.

Gel warmer cable Cable tie needs to thread through the mounting hole in connector of Gel warmer

Cable tie

Figure 14.26-ZS3

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ZS3 Intracavity probe holder

The intracavity probe holder is an optional module of the system for supporting the intracavity probe.

OVERVIEW

Figure 14.27-ZS3. Diagram of the installation position of the intracavity probe holder

As shown, the intracavity probe holder is mounted on the upper right side of the control panel base.

The side view of the intracavity probe holder is shown in Figure 14.28. In the figure, 1 is the intracavity probe cup holder part 1, and 2 is the intracavity probe cup holder part 2.

1

2

Figure 14.28-ZS3. Intracavity probe holder bracket side view

The front view of the intracavity probe holder is shown in Figure 14.29. In the figure, 1 is the intracavity probe holder part 1, and 2 is the intracavity probe holder part 2.

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1

2

Figure 14.29-ZS3. Front view of the intracavity probe holder

The top view of the intracavity probe holder is shown in Figure 14.30. In the figure, 1 is the intracavity probe holder part 1, and 2 is the intracavity probe holder part 2.

1

2

Figure 14.30-ZS3. Top view of the intracavity probe holder

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HOW TO INSTALL THE INTRACAVITY PROBE HOLDER 1. Assemble the intracavity probe holder part 2 into the intracavity probe holder part 1 from top to bottom in the direction of the arrow.

Figure 14.31-ZS3. Diagram of the assembly of the intracavity probe holder part 1 and part 2

2. Align the slot 1 and the slot 2 on the intracavity probe holder with the control panel base hook 1 and hook 2, respectively.

Slot 1

Slot 2

Hook 2 Hook

1

Figure 14.32-ZS3. Alignment of the intracavity probe holder bracket and hook

3. Install the probe holder in the direction of the arrow from top to bottom shown in Figure 14.33, so that the clip on the bracket snaps into the base flange of the control panel.

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Flange

Buckle

Figure 14.33-ZS3. Diagram of the assembly of the intracavity probe holder

4. For machine that has been configured with a storage basket, the storage basket pad needs to be first mounted to the basket flange and the basket is secured to the hook of the intracavity probe holder.

Basket pad

Flange

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DISASSEMBLING THE INTRACAVITY PROBE HOLDER Gently push the bracket handle position in the direction of the arrow until the buckle is released from the control panel base flange and then remove the bracket from bottom to top.

Figure 14.34-ZS3. Diagram of the removal of the intracavity probe holder

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15 Software Procedures

Backup Operations

Backing up imaging presets and system configuration:

1. If there are customized imaging presets and system configuration that are desired to be backed up, insert a target USB stick for backup into the USB port on the front or rear of the system. 2. Enter [Setup] → [Back/Restore] to perform "Imaging presets" and "System Configuration" backup operation.

• Imaging Presets:

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Select [Imaging Presets] to enter the "Export Module Data" screen. Select the desired destination from the drop-down list of Drive. File name may be changed as desired. Click OK to begin the backup process.

• System Configuration: The backup SYSTEM operation provides capability for selecting the granularity for the specific parameters that will (or will not) be used during the Backup operation. The selectable options, and a description of what parameters are included in each item, are listed below:  Annotation/Body Patterns (User Annotation and customer Body Markers)  Programmable Keys (Program keys; Image Store/Print button; Store)  Protocols (Including Stress Echo)  Calculation Setup (User Calculation setup parameters)  Location Manager (preset information, including DICOM, FTP, Print etc.)  Network/DICOM (Network, Storage, Print, Worklist, MPPS, Storage Commitment, Query/Retrieve/ HL7Query)  Other System Settings (Region, General, Audio/Video, Security, Print Service etc.)  Custom Worksheets & Linkages (QPath/QView) After selecting the desired items, click [System Configuration: Select items to backup] to backup the selected data. Or you can click [System Configuration All] to backup all the system configuration data. Select the desired destination from the drop-down list of Drive. File name may be changed as desired. Click OK to begin the backup process.

Restore Operations

1. Insert the same USB stick stored with the backed up data. 2. Enter [Setup] → [Back/Restore] to perform "Imaging presets" and "System Configuration" restore operation. • Restore Imaging Presets

1. Restore all:

Select [All] in the "Restore Imaging Presets" region to enter the "Load Data" screen, select the data to be restored, and then the system enters the following page:

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User Presets (3 Options)  Retain customer imaging parameters and incorporate factory enhancements (Suggested)  Keep all customer imaging parameters. Do not incorporate factory enhancement (Recommended)  Retain customer preset names but set ALL imaging parameters to factory setting. Preset linkages: Preset Linkages allow for determining whether specific transducer type/exam type presets are linked directly to specific annotation and custom worksheets/report (or not), as part of the Preset “RESTORE” process. Checking of the box associated with each category will result in Preset Linking configuration being actively restored.

 Annotation/Body Patterns (User Annotation and customer Body Markers (linked))  Custom Worksheets/Reports: (QPath custom worksheets and reports (linked))  Quick Presets (User configuration for exam preset selections assigned to scanner ICONS and ZS3 OLED display)  Presets On/Off State (User configuration of hiding or displaying of User presets in Preset menu)

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2. Restore according to exam type

Select [Exam Type] in the "Restore Imaging Presets" region to enter the "Load Data" screen, select the data to be restored, and then the system enters the following page:

Select a desired transducer and exam types (you can select 1 or more exam types), and then click [Restore] to begin the restoration. (This operation requires an automatic reboot) 3. Restore according to single preset

Select [Single Preset] in the "Restore Imaging Presets" region to enter the "Load Data" screen, select the data to be restored, and then the system enters the following page:

Select a desired transducer, exam type, and preset items (you can select 1 or more user-defined preset items under only 1 exam type), and then click [Restore] to begin the restoration. (This operation requires an automatic reboot) • Restore System

The selectable options for the “RESTORE SYSTEM” operation, and a description of what parameters are included in each item, are listed below:

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 Annotation/Body Patterns (User Annotation and customer Body Markers)  Programmable Keys (Program keys; Image Store/Print button; Store)  Protocols (Including Stress Echo)  Calculation Setup (User Calculation setup parameters)  Location Manager (preset information, including DICOM, FTP, Print etc.)  Network/DICOM (Network, Storage, Print, Worklist, MPPS, Storage Commitment, Query/Retrieve/ HL7Query)  Other System Settings (Region, General, Audio/Video, Security, Print Service etc.)  Custom Worksheets & Linkages (QPath/QView)

After selecting the desired items, click [System Configuration: Select items to restore] to restore the selected data. Or you can click [System Configuration All] to restore all the system configuration data.

• FACTORY Restore

 Click [All] to restore the imaging presets and system configuration to the factory default preset.  Click [FACTORY Presets] to restore the imaging presets to the factory default preset.  Click [FACTORY System Configuration] to restore the system configuration to the factory default preset. Note: Restoring Factory defaults will cause the system to lose custom presets and settings. A backup should be performed before attempting to restore to Factory defaults.

Note: Patient data converted to DCM file is compatible with 9.0 system only for review, not measurement.

Software Upgrade & Installation

Mindray/Zonare periodically releases new software for your system. The upgrade pro- cedure is simple and can be performed by the end user. Total installation time is approximately 15 minutes. The method for accessing system software package: • Standard: A USB stick preloaded with system software provided by Mindray. • Alternate: Direct FTP download (over the Internet) of system software to an installed USB stick using a network connection on the ZS3 system.

For information on the latest software revision level, contact Mindray/Zonare Technical Support.

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Verifying Current System Software Revision

To verify current software revision, press the Service key, and the software revision is displayed in the top left corner of the User Diagnostics Panel.

Installing Software on a ZS3 System at 9.x Software Revision (Factory Clean Install)

NOTE: The following procedure is to perform software installation or upgrade at a system running 9.x software. To upgrade software from 7.x to 9.x revision, skip to next procedure.

1. Plug a USB stick in one of the four USB slots on the ZS3 system.

2. Perform system backups by going into Setup and Backup/Restore menu.

NOTE: Make sure the imaging presets and system configurations are backed up to a USB stick. The software factory clean installation will erase all system and imaging presets. 3. Turn off the system.

4. Press and hold the UNDO key and then turn on the system. Do not let go of the UNDO key until system is at white bootup screen. This will force the system into a RECOVERY mode. 5. If this method does not work and the system boots all the way to imaging screen, go to Service  Maintenance  Service Reboot. Respond “Yes” to reboot. Immediately after pressing Service Reboot, press UNDO key and hold it until the white software boot screen appears. 6. Plug the USB stick with 9.x.xxxx software and DAT file into one of the USB ports. 7. Select the option for ‘Recovery’.

8. When system prompt “Select Reboot to perform an install’, press F4 or select it using the GUI interface. System will reboot back to the white screen. 9. Press Optimize, then press the Caliper/Measure button to get the “Factory Clean Install” option.

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10. Select the option for Factory Clean Install or press the F1 key to initiate the install. 11. Follow the on screen prompts to complete the installation.

12. At the completion of a successful software installation/verification process, a dialogue box with the following message should appear on the LCD Display screen

13. Remove the USB Memory Stick, and press the “ENTER” key on cart again to finalize the software installation. The system should perform an automatic reboot, powering back up in a fully operational condition. 14. Perform Restore operation to restore your system settings and imaging presets.

Upgrading System Software from 7.x to 9.x Revision

NOTE: For system running 7.6.1257D software, upgrade to the latest 7.6 revision first before performing 9.x upgrade.

NOTE: This upgrade requires formatting of the SSD which stores patient data. Be sure to backup all patient studies prior to the upgrade.

NOTE: Studies performed at software revision 7.6 and lower cannot be imported back into the system after the 9.x upgrade.

NOTE: Following hardware is required to support optional ARFI feature. Contact Mindray to order parts or upgrade kit if necessary. • Scan module (for ARFI feature) – PN 115-051400-00 or 115-051402-00 • Power supply (for ARFI feature and improved battery operation) – PN 115- 052756-00 • User interface (with updated keys for 9.x software) – PN 115-052849-00

1. Disconnect Wireless bridge/Ethernet cable from the system. Do not plug in the wireless bridge until the very last step of this procedure.

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2. Perform System and Imaging Preset backups in Setup  Preset Admin

3. Backup Worksheets under Setup  System Setup  Calcs  Usr Worksheets  Backup. 4. Export log files under Service  Store current logs  Export logs  Export all.

5. Take pictures of setup pages to ensure successful setup post upgrade.

a. Setup pages: Network, DICOM, annotations, monitor settings, etc.

b. Service pages: Details, Settings, License info, etc.

6. Format SSD under Service  Maintenance  Service Reboot  Service  Format Cart HD. NOTE: Be sure to backup all patient studies prior to the upgrade. NOTE: Formatting the SSD is highly recommended but is optional. If the SSD is not formatted during the upgrade, part of the SSD storage will be occupied by 7.x exams and won’t be available for 9.x system exams. As a result, space available on SSD for patient data storage will be limited. NOTE: The SSD must be formatted if patient exam data encryption will be enabled. NOTE: Documenting the Encryption password is the sole responsibility of the customer. Mindray cannot recover or provide the password. In the event it is lost, the only way to disable the encryption is to reformat the SSD.

7. If applicable, turn off the system and follow instructions on this service manual to upgrade the hardware. 8. Press and hold the UNDO key and then turn on the system. Do not let go of the UNDO key until system is at white bootup screen. This will force the system into a ‘RECOVERY’ mode. 9. If this method does not work and the system boots all the way to imaging screen, go to Service  Maintenance  Service Reboot. Respond “Yes” to reboot. Immediately after pressing Service Reboot, press UNDO key and hold it until the white software boot screen appears. 10. Plug the USB stick with 9.x software and DAT file into one of the USB ports.

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11. Select the option for ‘Recovery’.

12. When system prompt “Select Reboot to perform an install’, press F4 or select it using the GUI interface. System will reboot back to the white screen. 13. Press Optimize, then press the Caliper/Measure button to get the “Factory Clean Install” option. 14. Select the option for Factory Clean Install or press the F1 key to complete the install.

NOTE: If the upgrade is not successful, downgrade the system to the original software and restore the presets and settings.

15. Perform Cart firmware upgrade under Service  Maintenance  Upgrade Firmware (CartFirmware) 16. Perform Monitor firmware upgrade under Service  Maintenance  Monitor Setup a. Choose the monitor type in the dropdown. b. Click on Update Dock Board and User Settings. c. Exit the page and then go back into Monitor setup and hit ‘Update Dock Board and User Settings’ again. d. Check monitor firmware under Details tab on Service. e. Go to Setup  System Setup  Display  Audio/Video. If settings are OK, press Apply. If a popup reflects a mismatch of settings and the second line of settings on the popup is correct (system configuration), select NO to the popup, and this page will be updated with the ‘second line’ of values from the pop up window (which should match what was just displayed on the Maintenance monitor setup page). NOTE: Changing monitor settings from those specified by the manufacturer is highly discouraged. f. If the popup window shows a mismatch of monitor settings and software and you would like to use the first line of values (these are currently ON the monitor), choose YES and return to the Maintenance page and enter desired values in ‘Custom Category’ to make sure all values match. g. Click ‘Apply’ at the bottom to store the values on this page. 17. Setup system based on pictures taken in Step 5.

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18. Presets are at factory default after the upgrade. If necessary, build presets from scratch for each transducer (to be performed by clinical team). 19. Set correct Date/Time under Setup  Region.

20. Perform system check

a. Check monitor settings are correct – Setup  Audio/Video. b. Connect Ethernet cable and check if DICOM server and Worklist server can be Pinged and Verified. • DICOM server: Setup  DICOM  Set DICOM service  Storage • Worklist: Setup  DICOM  Set DICOM service  Worklist 21. Plug in transducer and make sure you get an image. Switch transducers and test all ports. 22. Pull patient from Worklist, if applicable.

23. Perform a test study.

24. Send to DICOM server, if applicable.

25. Print an image, if applicable.

26. Setup the Wireless bridge a. Power off the system. b. Plug in the wireless bridge. c. Turn on the system and wait for bridge to come back online. d. Make sure the wireless icon and signal bar are displayed in the bottom right corner of the screen. e. Test wireless connectivity by sending a test exam to DICOM storage.

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Diagnostic Panel Operations

The User Diagnostics Panel allows service personnel access to important system information and the ability to perform service support processes.  To access the User Diagnostic Panel 1. While viewing an imaging display, press the Service key on the QWERTY keyboard:

• A single short press activates the User Diagnostics Panel. • An extended press (> 3 sec.) will initiate an immediate manual capture of the system error logs, store the current logs; the system beeps as logs are stored.. 2. Press Service again to return to imaging.

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The Diagnostics menu on the ZS3 offers (or will offer in subsequent software/hardware releases) the following functionality: • Display system serial number • Display system software revision level • Display the revision level of major PC boards • Display system status to log files • Capture current image screen and storing as a BMP file • Transfer the contents of the internal log directory (using an internet connection) to the Mindray/Zonare FTP site • Check (over the internet) for availability of software and firmware (cart) updates from the Mindray/Zonare FTP site • Enable transducer tracking • Enable teaching exam NOTE: The majority of the functions in the User Diagnostics Panel involves the use of an internet connection between the ZS3 system and Mindray/Zonare’s network server for uploading or downloading files. Performing any of these procedures requires contacting Mindray/Zonare Technical Support to received specific information on IP address and log in used to make the connection. The features in the User Diagnostics Panel are described

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Parameter Description

System . The current system software revision and system serial number appear here. . Click the Details button for PC board revision information.

. License info: display the currently configured features and transducers.

. License Update: update a new license through the USB disk containing a license file

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Software Updates . Check FTP for latest available software. . If new version available, then option to download to USB media from FTP site.

Firmware Updates . Check for firmware updates for cart assemblies . Press Maintenance button to perform available updates.

Store Current Logs . Store the logs to local disk

Store Image . Store the image to local disk

Clear Logs . Clear all logs or clear logs by date

Export Logs . Export all logs or export logs by date (this button is active only after an USB disk is inserted to the ultrasound system)

Send System Logs . Send logs to the remote server

Start Capturing . To capture the DICOM logs Network Packets

Access Transducer . Check the transducer operation logs in an exam type. Patient Tracking

Enter Password . Encrypt the patient ID in the transducer operation logs.

Enable Teaching . Enable the teaching exam function. Exam

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The additional functions available beyond the main page of the User Diagnostic Panel, in these three sub-menus, are as defined below: SETTINGS 1. Click Settings on the User Diagnostic Panel. 2. Select the desired settings and click [OK].

Parameter Description

Software Upgrade Options . FTP Address 12.40.200.87, user name ZS3 and password support are supplied by Mindray/Zonare. Click Ping button to test connectivity to software folder on FTP site. . Select the Auto notify of software updates to check FTP server for the latest software revisions and then select the number of days until next check.

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Log Reporting Options . Select to enable sending logs to remote FTP site. . Select Display service key log info dialog. This allows a pop-up box when logs are captured for user to enter a message. . FTP Address 12.40.200.87, user name LOGS and password support are supplied by Mindray/Zonare. Click Ping button to test. . Select Auto Logging to have system automatically send logs. You can select daily, every xx weeks on yy day of the week. . Select Auto Logging Time to have logs automatically sent at a certain time of day. . Select Error Logging to have logs automatically sent when error occurs.

Idle Timeout(Minutes) . Idle interval for "phantom" exam.

Phantom Last Name Regex . a pattern in Last Name field to be identified as "phantom" exam.

FTP Data Transfer Mode . In active mode FTP, the server initiates the data transfer; and in the passive mode FTP, the client initiates the data transfer.

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MAINTENANCE 1. Click Maintenance on the User Diagnostics Panel. 2. Select the desired features and click [OK].

Parameter Description

Cart Power Board . Select Upgrade Firmware (CartFirmware) to update power supply firmware. . Select Recondition Battery to start recondition cycle on cart battery. May take 13+ hours to complete. . Select Battery Status to view cart battery values

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• VWALL:24V +/- 5% (only when AC present) • Battery Voltage: 13-19.5V • Battery Temperature: 27°C / 0 to 40°C • Charging State: o OFF ------0 o SOFT_START ------1 o TOP_OFF ------2 o RAPID_CHARGE ------3 o TRICKLE ------4 o MAINTENANCE ------5 o RECONDITION ------6 o COOL_DOWN ------7 o DRIVE_DONE ------8 o RECONDITION_INIT ------9 • Norminal Capacity (LMD): 12960mAH (162) • Battery Charge 15000 nominal * Below this range would be considered a ‘bad’ (needing replacement) battery. • Above this range should be considered an invalid value.

Enable Debug Console . Allows (if checked) or disables (if unchecked) access to the System Console window (ALT-GR / Shift / Z keys) for entering low-level commands for service. Lock-out offered due to same key combination used for international character text entry during normal use.

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. Displays a linear image format for all transducer types, to Transducer Diagnostics identify possible missing channels/elements. . Pressing the “SET” key will toggle between the two testing segment screens (element 1-64, 65-128), to cover all elements in the transducer under test. . Set the monitor parameters. Monitor Setup

. Reboot and enter the software installation screen. Service Reboot

. To set the bitmap displayed in powering on the system. Vender ID

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16 Care and Maintenance

Overview

This section describes the maintenance, care and service recommended to maintain the ZS3 system in proper operation.

Mindray ultrasound systems are designed to be maintenance free. Our ultrasound systems do not require regular preventative maintenance such as calibration or adjustments to the hardware and transducers. Mindray has developed procedures to allow you to perform annual quality checks designed to support your facilities Quality Control requirements. For customers without the necessary equipment or resources to perform these checks, Mindray can provide this service for a fee.

WARNING: Shock hazards exist if the AC power connection for the ZS3 system or AC adapter are not properly grounded. Equipment must be connected to a hospital grade receptacle. Do not remove the grounding wire. The enclosures contain no operator-serviceable components other than the scanner module. • To avoid electrical shock, do not remove covers other than the scanner module cover. • For servicing, contact Mindray/Zonare Technical Support only. Failure to do so may void your warranty or service contract coverage. To safely use and maintain the system: • To avoid electrical shock, always disconnect the AC power before cleaning any part of the ZS3 system. • Do not immerse the transducer past the cleaning/disinfection level depth specified in “Cleaning and Disinfecting Transducers.” Do not immerse the transducer for longer than specified cleaning/disinfecting time. Do not use any transducer that has been immersed beyond the specified level. Improper cleaning or disinfection of any part of the ZS3 system can cause permanent damage. Follow the cleaning and disinfection instructions.

CAUTION: Do not excessively twist or bend the cables; this can cause failure • Improper cleaning or disinfection of any part of the ZS3 system can cause permanent damage. Follow the cleaning and disinfection instructions.

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• Do not use solvents or abrasives to clean any part of the ZS3 system. • Do not spill liquid on the ZS3 system. • Do not immerse the battery in water or allow it to get wet. • Do not put the battery into a microwave oven or pressurized container. • Use only Mindray/Zonare batteries. • Store the battery between 32F and 120F (0 and 50C). • If the battery leaks, emits odors, emits heat, or is deformed or discolored in any way, immediately stop using the battery.

Basic System Care

LCD Display Cleaning WARNING: Take care not to damage or scratch the glass or LCD panel. Do not apply pressure on the glass or LCD panel. Do not apply or spray liquid directly to the glass, panel, or cabinet as excess liquid can cause damage to internal electronics. Apply the liquid to the cleaning cloth. WARNING: Do NOT use any of the following: • Lye or cleaning solutions containing lye • Acid • Detergents with fluoride • Detergents with ammonia • Detergents with abrasives • Steel wool • Sponge with abrasives • Cloth with thread made of steel • Other coarse tools • Do not autoclave, immerse, or attempt to sterilize the LCD display. CAUTION: Spray cleaning solution on the cloth, NOT on the display. 1. Before cleaning, turn off the AC circuit breaker and pull out the battery plunger on the ZS3 system to remove all power from the unit. 2. Clean the glass using a soft cotton cloth lightly moistened with a watery solution or a mild commercial screen-cleaning product. 3. Wipe dry with a clean, dry, soft, lint-free cloth.

Control Panel Cleaning  Tools: soft dry cloth, soapy water  Method:

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Use a soft dry cloth to clean the surface of the control panel (including the keys, knobs and sliders). If the control panel is dirty, moisten the soft cloth with a little mild soapy water and wipe away any stains. Use another soft dry cloth to remove any moisture and allow all hard surfaces to completely air dry. If the control panel is difficult to clean, remove the knob caps first and then clean it with mild soapy water.

NOTE: The keyboard on the control panel should be cleaned periodically to ensure proper operation of the keyboard.

Exterior Surface Cleaning 1. Before cleaning, turn off the AC circuit breaker and pull out the battery plunger on the ZS3 system to remove all power from the unit. 2. Wipe the ZS3 system surfaces with a safe disinfectant solution such as Sani-Cloth Plus or isopropyl 50% alcohol and follow the disinfectant label instructions for use. 3. Repeat with water moistened soft cloth only. 4. Wipe dry with a clean, dry, soft cloth.

WARNING: Do not expose the exterior surface of the LCD display to any of the following agents: • Cidex • Betadine

WARNING: • Do not use disinfectants (such as gluteraldahyde or hydrogen peroxide) or acetone to clean any surfaces on the ZS3 system or its accessories. • Before cleaning, turn off the AC circuit breaker and pull out the battery plunger on the ZS3 system to remove all power from the unit. • Do not autoclave, immerse, or attempt to sterilize the LCD display or transducers. • Do not spill or spray liquid directly on the control panel, LCD display, battery charger, AC power adapter, or transducer connector.

WARNING: To avoid electrical shock, turn off the AC circuit breaker at the rear of the system before cleaning the ZS3 system. Always use protective eyewear and clothing when cleaning or disinfecting the ZS3 system. • The level of disinfection required for cleaning the ZS3 system is dictated by the type of contaminants the system came in contact with.

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• If using a premixed disinfection solution, check the solution expiration date to ensure that the solution has not expired. Do not used expired solutions.

Module Air Filter Cleaning • Remove the module cover. • To remove the air filter, hold it by the pull tab located centrally on the front of the frame and pull. • Clean the module filter using soft brush to remove lint and dust. • If particulate is still visible, use a can of compressed air to blow it out. • To reinstall the filter, hold it with one hand on each end. Position the filter with a slight downward tilt to engage the clip under the handle. Slowly push

the filter until fully inserted. Use a plastic card to push the filter flap down behind the module handle. • Put the module cover back into place.

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Transducer Maintenance

Check the transducers regularly for signs of wear or damage. WARNING: Bent, broken, or missing pins on the transducer connector can cause poor image quality, including possible mirror image artifact. Be sure to check pins before connecting a transducer to the ZS3 system. If pins are bent, broken, or missing, do not use the transducer and call Mindray/Zonare Technical Support.

Figure 16.1-ZS3

System Check

Follow the procedures below to verify the correct operation of the system.

Mechanical and Visual Inspection 1. Verifying System Display 1.1. Verify the Display is securely mounted to the system.

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1.2. Turn Display left and then right. Verify Display moves freely in both directions. 1.3. Tilt Display up and then down. Verify Display moves freely in both directions.

2. Verifying System Controls 1.1. Pull the lift release handle. Raise and lower the system upper User Control Panel. 1.2. Verify the Control Panel moves up, down, and locks when button released. 1.3. If control panel drifts after releasing the button, or will not release, an adjustment of the control cable may be required. Contact Technical Support.

3. Verifying Wheel & Brake Operation 1.1. Visually inspect the wheels and wheel brake for damage. 1.2. Verify brake operation. Engage the brake on each wheel and verify that they lock. 1.3. Release locks and rotate. 1.4. Verify straight-line wheel track locking by engaging the straight-line wheel locks. 1.5. Roll the cart and ensure the wheels do not swivel.

4. Verifying Cable & Peripheral Connectivity With all System power disconnected, verify the following: 1.1. Check the AC power cord for damage or excessive wear. 1.2. Verify the peripherals are securely attached. 1.3. Verify the peripheral cabling is properly connected.

5. Verifying Probes 1.4. Verify there is no pin-holes or damage on the probe lenses. 1.5. Check the probe head, cable and connector for damage or excessive wear. 1.6. Verify the lock on the probe connector is working properly. 1.7. Visually assess images for vertical shadows and streaks caused by dead elements in the transducer.

System Functionality Check 1. Verifying System Controls 1.1. Power on the System. 1.2. Verify the trackball is working smoothly. 1.3. Verify the operation and backlighting of all the Control Panel buttons.

2. Verifying System Operation 1.1. Verify the System completes the boot sequence. 1.2. Attach a transducer and confirm 2D (B-mode) is enabled and image is displayed on the display.

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1.3. Locate the Depth button beneath the 2-D (B-mode) button. Toggle downward to maximum depth. 1.4. Rotate the outer knob of the 2-D button until the gain equals 100 on the display monitor. The image should be a bright uniform gray image with little if any visible variation. Adjust TGC sliders, if available, to the right. 1.5. Turn on color mode by pressing the Color button. A Region of Interest (ROI) box will appear. Use the trackball to move the box to the upper left corner of the image. Press the set button to lock the location in place. 1.6. Use the trackball to enlarge the ROI to the lower right corner of the image. This will maximize the size of the box. 1.7. Turn the color gain to the maximum value of 100 as displayed on the main monitor. The image inside of the box should be red and blue and looks similar to confetti.

NOTE: The next step involves activating Doppler which may cause the system to emit a loud sound. Be prepared to turn down the volume using the rotary knob beneath the OLED that says “Volume”.

1.8. Press the Doppler (D-mode) button to turn on Doppler mode. The image should reduce its size and a horizontal strip will appear below the ultrasound image. A cursor with a gate will appear in the image. The horizontal strip should be moving from left to right. If the strip is not moving from left to right, then locate the OLED that says “B-Update” and press the button associated with the OLED to activate the horizontal strip. 1.9. Use the trackball to move the cursor from lower right to upper left and visa-versa several times. Each time you move the cursor, the horizontal strip should stop and re-start. Please verify that the strip restarts each time. 1.10. Verify the cart outputs white noise via the display monitor speakers. You may have to adjust the volume located in the right side of the OLED display. 1.11. Press the M-Mode button. Verify that a different but similar horizontal strip appears beneath the ultrasound image. 1.12. Move the cursor from bottom right to top left several times. Ensure that the strip movement is interrupted and restarts each time.

3. Verify Display Performance 1.1. Display the bar pattern using the menu path of Setup  System  Audio/Video  Bar Pattern. 1.2. Verify all the thin lines and gray scale bars/blocks can be clearly distinguished.

4. Verify Network Communication (if applicable) 1.1. Verify the system connecting to the network properly by checking the network icons on the main screen.

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1.2. Verify the DICOM services by going to Setup  DICOM  Set DICOM Service.

5. Verify Battery 1.1. Go to Service  Maintenance  Battery Status. 1.2. Check if the battery voltage is read. 1.3. Connect the machine to AC power to check if the machine is charging the battery.

6. Verify Printers (if applicable) 1.1. Acquire the desired ultrasound image. 1.2. Press the Freeze button to obtain a still image. 1.3. Press the Print button on the cart to trigger a print of the current onscreen image to the Sony B/W printer, or Sony Color Printer. 1.4. If print quality is less than optimal, clean the print head and test again. 1.5. If necessary, adjust the printer settings. Consult the printer manual for more instructions on settings.

7. Verify ECG (if applicable) 1.1. Press the ECG key on the keyboard to display ECG sweep line on the screen. 1.2. Verify there is no noise/artifacts on the ECG sweep line. 1.3. Connect an ECG simulator to verify the ECG signal can be displayed clearly.

8. Verify Footswitch (if applicable) 1.1. Connect the footswitch to the system. 1.2. Verify the foot pedals operate properly as configured in Setup  Keys.

9. Verify Barcode Reader (if applicable) 1.1. Connect the barcode reader to the system. 1.2. Verify the reader operates properly as configured in Setup  Peripheral  Barcode Reader Configuration.

Electrical Safety Inspection Only trained technical professionals or engineers can perform electric safety inspection. Please refer to "Appendix B Electrical Safety Inspection" for details.

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Transducer Imaging Performance Test

Test Requirements: 1. Display: set the contrast and brightness at the clinical application value (or the default status) 2. Operation environment: to enable proper on-screen image evaluation on the LCD display of the ultrasound system, ambient lighting should be maintained at a moderate level during the performance of this procedure. The lighting level should be compatible with traditional ultrasound lab environments.. 3. Electrical requirement: the transducer imaging and imaging performance testing shall be performed in an environment that is free of significant interference noise sources for the ultrasound product. The environment includes avoiding use of AC power outlets on lines shared by other electronic equipment in the vicinity. 4. Scanning techniques: put the probe on the acoustic window of the phantom, without spacing or pressing. NOTE: 1. The phantom images here are for reference only. 2. Refer to "Appendix A Phantom Usage Illustration". Phantom KS107BD is a low frequency phantom and used when probe focus frequency is less than 4MHZ; Phantom KS107BG is a high frequency phantom and used when probe focus frequency is more than 5MHZ. 3. Other quality phantom, such as Gammex 403 GS LE Precision Multi-Purpose Phantom can also be used. Refer to the phantom’s user manual for details.

1. Image Uniformity Verification Image Uniformity The displayed image should be uniform and should not present any artifacts or shadows.

Method of Testing The phantom contains pin targets and objects in different shapes. While scanning the phantom, those objects should be displaced clearly on a black background in the ultrasound image. There should not be any speckles, axial or lateral streaks.

Procedure: 1.1. Select a transducer for verification. 1.2. Select an Exam Type and Preset type. 1.3. Turn off Compounding (“Compounding Off”).

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1.4. Turn off Harmonics (“TH”). 1.5. Adjust TGC sliders, if available, to a straight line in the middle. 1.6. Scan the phantom and position the vertical pin targets in the center of the image. 1.7. Check if the image is displayed in a uniform gray scale and no dark streaks (drop-outs) are displayed.

2. Depth of Penetration Verification Depth of Penetration The maximum depth of penetration should remain constant over time. Variation indicates performance degradation.

Method of Testing The maximum sensitivity or depth of penetration is determined by measuring the depth in the phantom at which the usable echo information in the far field first disappears.

Procedure: 1.1. Select a transducer for verification.

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1.2. Select an Exam Type and Preset type. 1.3. Turn off Compounding (“Compounding Off”). 1.4. Turn off Harmonics (“TH”). 1.5. Using the Frequency paddle switch, select the lowest frequency available. 1.6. Using the Depth control, set the Depth to the maximum value. 1.7. Scan the phantom, positioning the vertical pin targets in the center of the image. 1.8. Press the Freeze key to stop imaging. 1.9. Press the Optimize key to optimize tissue gain levels. 1.10. Using the targets in the ultrasound phantom, determine the Penetration Depth (mm), where the target pins in the far field first disappear, for the selected transducer.

3. Geometric Accuracy Verification Geometric Accuracy Geometric accuracy is the closeness of a measurement on the ultrasound machine to its true value.

Method of Testing The phantom contains pin targets with fixed spacing on horizontal and vertical lines. The distance between 2 pin targets can be measured by the ultrasound machine and compared to the actual value to determine the geometric accuracy.

Procedure: 2.1. Select a transducer for verification. 2.2. Select an Exam Type and Preset type. 2.3. Turn off Compounding (“Compounding Off”). 2.4. Turn off Harmonics (“TH”). 2.5. Using the Frequency paddle switch, select the highest frequency available. 2.6. Scan the phantom and adjust the depth by using the Depth control to position the vertical and horizontal pin targets in the center of the image. 2.7. Press the Freeze key to stop imaging. 2.8. Press the Optimize key to optimize tissue gain levels. 2.9. Press the Measure/Caliper key to display the cursor and measure the distance between 2 target pins on the horizontal and lateral target lines respectively. 2.10. Use the formula below to calculate the axial and lateral accuracy. The acceptable accuracy tolerance is +/- 3%.

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17 Preventative Maintenance Forms

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Ultrasound System PM Report (Standard)

INFORMATION Account Name Model Name Model Serial Number Software Version Work Order Number TEST EQUIPMENT Leakage Tester Make Simulator Make Leakage Tester Model Simulator Model Leakage Tester SN Simulator SN Leakage Tester Cal. Due Simulator Cal. Due

Date Date ELECTRICAL SAFETY Leakage/Patient Ground resistance(ohms) (Probe/ECG Wire) (uA) Leakage/Chas. (uA) FUNCTIONAL / PHYSICAL / MECHANICAL CHECK Power cord, Self diagnosis Pass Fail N/A Pass Fail N/A adapter/breaker Casters, brakes Pass Fail N/A Air filter Pass Fail N/A Control panel Pass Fail N/A Battery Pass Fail N/A Trackball Pass Fail N/A CD/DVD drive Pass Fail N/A Handle, latch, door, etc. Pass Fail N/A ECG Pass Fail N/A Monitor, touch screen Pass Fail N/A Network, USB ports Pass Fail N/A Monitor arm Pass Fail N/A Peripheral devices Pass Fail N/A Scanning operation Pass Fail N/A TRANSDUCERS N/A Functional/Visual Probe Model # Probe Serial # Comments Check Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Corrective Action Required? Yes No If so, description:

Additional Comments

Dat Name Signature e

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Ultrasound System PM Report (Comprehensive)

INFORMATION Account Name Model Name Model Serial Number Software Version Work Order Number TEST EQUIPMENT Leakage Tester Make ECG Simulator Make Leakage Tester Model ECG Simulator Model Leakage Tester SN ECG Simulator SN Leakage Tester Cal. Due ECG Simulator Cal.

Date Due Date Phantom Make Phantom SN Phantom Cal. Due Phantom Model Date ELECTRICAL SAFETY Leakage/Patient Ground resistance(ohms) (Probe/ECG Wire) (uA) Leakage/Chas. (uA) FUNCTIONAL / PHYSICAL / MECHANICAL CHECK Power cord, Self diagnosis Pass Fail N/A Pass Fail N/A adapter/breaker Casters, brakes Pass Fail N/A Air filter Pass Fail N/A Control panel Pass Fail N/A Battery Pass Fail N/A Trackball Pass Fail N/A CD/DVD drive Pass Fail N/A Handle, latch, door, etc. Pass Fail N/A ECG Pass Fail N/A Monitor, touch screen Pass Fail N/A Network, USB ports Pass Fail N/A Monitor arm Pass Fail N/A Peripheral devices Pass Fail N/A Display performance Pass Fail N/A Scanning operation Pass Fail N/A TRANSDUCER #1 Probe Model Probe SN Physical / Mechanical Depth of Pass Fail Check Penetration(cm) Uniformity(element Uniformity(brightness) Pass Fail Pass Fail dropout) Geometric Geometric Pass Fail Pass Fail Accuracy(axial) Accuracy(lateral) TRANSDUCER #2 Probe Model Probe SN Physical / Mechanical Depth of Pass Fail Check Penetration(cm) Uniformity(element Uniformity(brightness) Pass Fail Pass Fail dropout) Geometric Geometric Pass Fail Pass Fail Accuracy(axial) Accuracy(lateral) TRANSDUCER #3

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Probe Model Probe SN Physical / Mechanical Depth of Pass Fail Check Penetration(cm) Uniformity(element Uniformity(brightness) Pass Fail Pass Fail dropout) Geometric Geometric Pass Fail Pass Fail Accuracy(axial) Accuracy(lateral) TRANSDUCER #4 Probe Model Probe SN Physical / Mechanical Depth of Pass Fail Check Penetration(cm) Uniformity(element Uniformity(brightness) Pass Fail Pass Fail dropout) Geometric Geometric Pass Fail Pass Fail Accuracy(axial) Accuracy(lateral) TRANSDUCER #5 Probe Model Probe SN Physical / Mechanical Depth of Pass Fail Check Penetration(cm) Uniformity(element Uniformity(brightness) Pass Fail Pass Fail dropout) Geometric Geometric Pass Fail Pass Fail Accuracy(axial) Accuracy(lateral) TRANSDUCER #6 Probe Model Probe SN Physical / Mechanical Depth of Pass Fail Check Penetration(cm) Uniformity(element Uniformity(brightness) Pass Fail Pass Fail dropout) Geometric Geometric Pass Fail Pass Fail Accuracy(axial) Accuracy(lateral) Corrective Action Required? Yes No If so, description:

Additional Comments:

Name Signature Date

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18 System Troubleshooting

Many malfunctions are caused by a routine problem, such as power disconnection or the maladjustment of basic imaging or peripheral device (LCD display) controls. Before calling Tech Support, please perform the following troubleshooting procedures on the affected component(s). The troubleshooting information in this section is intended to assist in diagnosing potential causes of a variety of system problems. It should be noted that as a result of the advanced level of integration in the electronic circuitry of the ultrasound system, the amount of service/repair that can be performed in the field, is limited to a specific number of FRU’s (Field Replaceable Units).

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Diagnostics

COLLECT VITAL SYSTEM INFORMATION Press the Service key on the control panel. The following information is necessary in order to properly analyze data or images being reported as a malfunction or being returned to the manufacturer: System Serial number (also visible on label on the rear of the system) System Software version Additional information (e.g., Details, “Module”, “Revision”, etc.)

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CHECK POINTS VOLTAGES When the system is connected to AC

#1: SOLID ON; #3: SLOW BLINKING

Figure 18.1-ZS3 When the system is fully booted up.

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#1: SOLID ON; #4-7: SOLID ON AFTER COMPLETE BOOT UP. #3: FAST BLINKING AT FIRST THEN SOLID ON.

Figure 18.2-ZS3

SCREEN CAPTURES AND LOGS For details, please refer to "Diagnostic Panel Operations".

EXPORT LOGS AND SYSTEM DATA Obtain Logs In case you can still enter Doppler user interface. 1. When a problem occurs, press and hold the "Service" key on the keyboard until a beep is heard and a dialogue box appears on the screen. Enter brief problem description and click [OK] to save. 2. Insert a USB stick into the system. 3. Press “Service” key on the keyboard, click Export Logs, select [Export all]. The logs will automatically get exported to the USB stick. 4. Zip the LOGS folder on your PC and send to us.

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In case you can’t enter Doppler user interface. 1. When the system is powered off, insert a USB stick into the system. 2. Turn on the system and press the “Freeze” button repeatedly until you get into BootApp interface as shown as below. 3. Press “Export system Logs”, the logs will be exported in a folder on your USB stick. 4. Zip the LOGS folder on your PC and send to us.

Figure 18.3-ZS3

Troubleshooting

TRANSDUCER PROBLEMS Caution: Bent, broken, or missing pins on the transducer connector may cause poor image quality, including possible mirror image artifact. Be sure to check pins before connecting transducer to the Mindray/Zonare ultrasound system. If pins are bent, broken, or missing, do not use the transducer and call Mindray/Zonare Technical Support.

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Figure 18.4-ZS3 Figure 1: Transducer Connector Pin Damage – (Example) Inspection of Transducers 1. Routinely inspect transducers for the following problems.

• Signs of wear or damage to the housing, cable, etc.

• Cracks in case or transducer face.

• Cuts or gouges on any part of the transducer, including transducer face, case, cable, and connector.

• Buckling or bulging of the lens material on the transducer face.

• Damage to the transducer connector, including bent, broken, deformed, or missing pins.

2. Immediately replace a transducer that exhibits any of the above damage symptoms.

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POWER-ON PROBLEMS System fails to power on 1. Ensure that the AC power is connected to a wall outlet.

2. Ensure the AC power cord is fully seated in the socket on the rear of the cart.

3. Ensure that the circuit breaker (located in the lower-left of the rear panel) is pressed down in the “1” (On) position.

4. With active AC power applied, verify that the LEDs located at bottom/rear of ZS3 system are in the following condition:

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The system cannot boot up

Check: Check AC LED (#1) 1. Power cable is properly N lights normally? connected 2. breaker is switched on.

Y

Press power button, Check: check Interlock LED N the module cover is correctly normally? installed?

Y

Disconnect the AC cable, wait Press power button, N 30s, reconnect the AC cable, check #5/6/7 LED solid? and restart the system.

Y

Press the power button and The monitor works N hold for 5s until the system normally? shuts down, and restart.

Y

Press the power button and System can normally N hold for 5s until the system boot up? shuts down, and restart.

Y

If you still cannot solve the problem, please contact the The system works normally service engineer.

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LED LED STATUS Definition # Solid: System has AC Mains applied and 5V

1 “AC Present” standby is active. OFF: No AC detected, circuit breaker off. OFF: No battery installed, or completely depleted, or system is being used on battery. 2 “Battery” Blinking: Battery charging (or reconditioning) in-process.

Solid: Battery is fully charged. “Controller Slow Blinking: When power button is

Status” pressed 3 Fast Blinking: Scan module is on and is waiting for application software

Solid: System is on and ready for use.

Solid: Module docked and cover “on”. 4 “Interlocks”

Solid: AC/DC 24VDC output is active. 5 “Vwall” OFF: No AC or circuit breaker tripped. Solid: 12V for cart peripherals. 6 “Vcart” OFF: No power to cart assemblies. Solid: 12V for Scan Module. 7 “Vdock” OFF: No power to Scan Module.

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When the cover is off or doesn’t engage the interlock switch, power button LED status is solid amber. When the cover is correctly seated and the cart is not turned on, LED is off.

Figure 18.5-ZS3 Power button LED blinks when the power button is pressed. When the system has booted to imaging, it turns solid green.

When the on/off button was pressed.

Figure 18.6-ZS3

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If either component fails to start up after these steps, contact Mindray/Zonare Tech Support.

PERIPHERAL PROBLEMS  19” Display monitor, no video • Power down the system, then switch off circuit breaker (at rear of system) to remove power to system electronics.

• Remove cover on back of monitor, and inspect/verify the cable connection.

 Sony B/W printer fails to power on • Check the power cord connections.

• Temporarily connect the power cord of the peripheral to a local receptacle, and test for operation of the peripheral.

• If the peripheral fails to power on after these steps, contact Mindray/Zonare Tech Support.

 Sony B/W printer fails to print • Check that the printer has paper available.

• Verify power button on the printer is on.

• Ensure that the USB cable is properly connected on the peripheral device, and connected internally to the USB Hub under the user interface and consult following table.

Lamp Status Cause/remedies

(green) On Printer powered on

PRINT (green) On Printing

Blinks Receiving image data

Blinking slowly Standing by until the thermal head is ready for printing. Wait until the PRINT lamp lights. Printing resumes automatically. PAPER (orange) On Add or reseat paper roll

ALARM (orange) On Door open > close door until it latches. Printer malfunction > Turn the printer off and back on. If error persists, contact

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Sony or Mindray/Zonare Technical Support • If the printer fails to print after these steps, contact Mindray/Zonare Tech Support.

TRANSDUCER PROBLEMS  Transducer not recognized by system (no B-mode imaging) • To ensure a positive connection, disconnect the transducer and reconnect it. • Inspect the metal contact pins on the transducer connector for any residue or damage. • Inspect the scan module port for any residue or damage. • Insert the transducer into a different port on the system. • To determine a problem with the transducer or system, attach a different transducer. • Disconnect the transducer. Power off the system. Power the system back on and reattach the transducer to test for functionality. • If system still fails to operate any transducers, contact Mindray/Zonare Tech Support.

IMAGING PROBLEMS  Poor B-mode image • Switch to a different transducer or probe port to see if the problem is with a particular transducer or system port.

• Ensure that there is an adequate supply of acoustic coupling gel and good patient/transducer contact.

• In the on-screen menu, under the Preset tab, select one of the factory default settings (General, etc.) to determine possible maladjustment of user presets.

• Adjust the various Doppler controls (gain, depth, frequency, etc.) to attempt to resolve the problem.

• Make sure the brightness and contrast settings of the LCD display have not been altered from proper settings. For information about LCD display settings, see LCD Display.

• To ensure the quality of the gray scale resolution of the LCD display, use the gray scale test pattern (via the Diagnostic menu) that is available. Ensure that all shades can be visualized, making small adjustments to brightness and contrast from factory defaults, as required, to see all intensities.

 No/poor Color Mode image or PW Doppler • Make sure the “C” or “D” mode dial turns green upon activation.

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• Make sure the brightness and contrast settings of the LCD display have not been altered from proper settings. For information about LCD display settings, see LCD Display.

• To ensure the quality of the gray scale resolution of the LCD display, use the gray scale test pattern (via the Diagnostic menu) that is available. Ensure that all shades can be visualized, making small adjustments to brightness and contrast from factory defaults, as required, to see all intensities. • Make adjustments to the various Doppler controls (gain, filter, scale) to attempt to resolve the problem.

• Ensure that the scanning angle between the transducer face and the direction of blood flow is optimized.

• In the on-screen menu, under the Preset tab, select one of the factory default settings (General, etc.) to determine possible maladjustment of user presets.

• Ensure that there is an adequate supply of acoustic coupling gel and good patient/transducer contact.

• Switch to a different transducer or probe port to see if the problem is with a particular transducer or system port.

GENERAL OPERATION PROBLEMS  Function (F1-F8) key(s) do not operate • Using the on-screen menu, go to Setup | Keys to access the menu and make sure the keys are correctly programmed.  Unable to modify existing User Preset (grayed out) • Make sure the desired user preset was previously (i.e., before attempting to modify it) selected as the active preset.  System will not communicate with target DICOM” Store” or “Print” device

• Check Networking ICON on upper/left corner of main imaging screen, to verify hardware connection is active (no “X” over ICON). Check hardware cabling, network equipment, and/or configuration, as necessary.

• Press the DICOM Queue key, and inspect for any pending jobs in the Queue. If any jobs pending, delete them and then power cycle System, and then re-test network state.

• Under “Setup | Network” configuration pages, verify the IP address/Gateway/Subnet Mask parameters are entered correctly, and correspond with those assigned to ZS3 ultrasound system by the IT Admin at the install site.

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• Under “Setup | DICOM” verify the AE Title assigned to the ZS3 system is correct.

• Select the Device List for the destination and hit “Ping”. If it fails, check IP address and make sure DICOM server is setup and active on the network. If it still fails, check with IT to confirm information entered is correct.

• Under “Setup | DICOM | DICOM Service | Storage” verify DICOM AE Title and port number are correct. Select the Service list and hit “Verify”. If it fails, check with IT to confirm information entered is correct.

• Under “Setup | DICOM | DICOM Service | Print” verify AE Title and port number are correct. Select the Service list and hit “Verify”. If it fails, check with IT to confirm information entered is correct.

• Using another device (PC, etc.) on same domain on hospital network, perform a “PING” operation to the IP address assigned to the system in the “Network” configuration page, to test for TCP/IP connectivity.

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System Status LED & Error Code Definitions

Rear I/O Panel – System Status Lamps The seven (7) system status indicator lamps located on rear of the system (panel just above the main AC circuit breaker) can be used to assist in troubleshooting problems with the system. The definition of the each lamp is as shown in the table below:

Figure 18.7-ZS3

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LED LED STATUS Definition # Solid: System has AC Mains applied and 5V

1 “AC Present” standby is active. OFF: No AC detected, circuit breaker off. OFF: No battery installed, or completely depleted, or system is being used on battery. 2 “Battery” Blinking: Battery charging (or reconditioning) in-process.

Solid: Battery is fully charged. “Controller Slow Blinking: When power button is

Status” pressed 3 Fast Blinking: Scan module is on and is waiting for application software

Solid: System is on and ready for use.

Solid: Module docked and cover “on”. 4 “Interlocks”

Solid: AC/DC 24VDC output is active. 5 “Vwall” OFF: No AC or circuit breaker tripped. Solid: 12V for cart peripherals. 6 “Vcart” OFF: No power to cart assemblies. Solid: 12V for Scan Module. 7 “Vdock” OFF: No power to Scan Module.

System Error Message Codes Error Code Subsystem Message for Error log User Error Message Action on Action NOTE: Various messages EUSCONTROL ostr.str() from function box 0xa00d0401 Detected Bad Channel In "Detected ADC Error. See 0xa00e0401 DIAGNOSTICS ADC Test. Logs for more errors." Continue "ADC Test Error In Setup: 0xa00e0402 DIAGNOSTICS Checking ADC status Failed Test Aborted." Continue 0xa6010401 CBKEY30A CB Console INIT error "CB Console INIT error” Continue "IOE30A LCD COMM 0xa6020401 CBKEY30A LCD Comm Error ERROR" Continue

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Error Code Subsystem Message for Error log User Error Message Action on Action "IOE30A SMBUS 0xa6030401 CBKEY30A SMBUS Error ERROR" Continue 0xa6040401 CBKEY30A Init Error "IOE30A INIT error" Continue "IOE30A BATT STATUS 0xa6040402 CBKEY30A Batt Status Retrieval Error RETRIEVAL ERROR" Continue "Cart Device Initialization Error. If error persists call 0xaf034005 HSSL_LINK ostr.str service." Continue "System fan Error: THERMALSER Please shutdown 0xaf050401 VICES Fan is stuck system." Stop "System Overheat THERMALSER Warning: Finish exam and 0xaf050403 VICES System Overheat Warning shutdown." Continue "Battery Overheat THERMALSER Warning: finish exam - 0xaf050405 VICES Battery Overheat Warning replace battery." Continue "System Overheat THERMALSER PWR_HV over warning Warning: Finish exam and 0xaf050430 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER PWR_LV over warning Warning: Finish exam and 0xaf050431 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER PWR_TSUPR over warning Warning: Finish exam and 0xaf050432 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER DIG_HYDRA over warning Warning: Finish exam and 0xaf050433 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER DIG_VSUPR over warning Warning: Finish exam and 0xaf050434 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER XMT_V5NA over warning Warning: Finish exam and 0xaf050435 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER XMT_VSUPR over warning Warning: Finish exam and 0xaf050436 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER RCV_AFE over warning Warning: Finish exam and 0xaf050438 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER RCV_CW over warning Warning: Finish exam and 0xaf050439 VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER RCV_LV over warning Warning: Finish exam and 0xaf05043a VICES Temperature Limit shutdown." Continue

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Error Code Subsystem Message for Error log User Error Message Action on Action "System Overheat THERMALSER RCV_VSUPR over warning Warning: Finish exam and 0xaf05043b VICES Temperature Limit shutdown." Continue "System Overheat THERMALSER Multiple Sensors over Warning: Finish exam and 0xaf05043c VICES warning Temperature Limit shutdown." Continue "MTP can't connect. Please disconnect and 0xaf0f0404 ACQCONTROL MPP can't connect reconnect." Continue "MTP can't connect. MPP can't connect. Voltage Please disconnect and 0xaf0f0405 ACQCONTROL Error reconnect." Continue "CW Error. Please CWBoard Current or Voltage disconnect and reconnect 0xaf0f0407 ACQCONTROL Error MTP." Continue

SYSTEM_SERV Watchdog Server: Task Not "Internal System Error 0xe0000401 ICES_EVA Responding has occurred." Restart "Internal System Error 0xe0004005 UNKNOWN Failed to configure FPGAs); has occurred." Restart Fatal Error due to NVASSERT. See above NVASSERT log statement "Internal System Error 0xe0004005 UNKNOWN for details has occurred." Restart "Internal System Error 0xe00a0401 IMAGING PIC is Invalid, No HV support has occurred." Restart HV's not the same when attempting dynamic update "Internal System Error 0xe00a0403 IMAGING of limits has occurred." Restart Failed to reset the PIC HV "Internal System Error 0xe00a0404 IMAGING task has occurred." Restart "Internal System Error 0xe00a0405 IMAGING Failed to set HV limits to PIC has occurred." Restart Failed to set QDAC voltage "Internal System Error 0xe00a0406 IMAGING to target has occurred." Restart "Internal System Error 0xe00a0408 IMAGING Can't Read voltage from PIC has occurred." Restart High Voltage not dumped "Internal System Error 0xe00a0409 IMAGING prior to power up has occurred." Restart "Internal System Error 0xe00a040a IMAGING VBoost error has occurred." Restart "Internal System Error 0xe00a040b IMAGING PFE HW Fault Error has occurred." Restart PIC version is invalid, No HV "Internal System Error 0xe00a040c IMAGING support has occurred." Restart

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Error Code Subsystem Message for Error log User Error Message Action on Action "Internal System Error 0xe00a040e IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a040f IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a0410 IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a0411 IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a0412 IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a0413 IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a0414 IMAGING HV Fault has occurred. " Restart "Internal System Error 0xe00a0415 IMAGING HV Fault - can't identify has occurred. " Restart Power Micro Driver failed to "Internal System Error 0xe00a0420 IMAGING disable HV has occurred. " Restart Power Micro Driver failed to "Internal System Error 0xe00a0421 IMAGING send Set HV message has occurred. " Restart "Internal System Error 0xe00a0422 IMAGING HV1N Not in limits has occurred. " Restart "Internal System Error 0xe00a0423 IMAGING HV1P Not in limits has occurred. " Restart "Internal System Error 0xe00a0424 IMAGING HV2N Not in limits has occurred. " Restart "Internal System Error 0xe00a0425 IMAGING HV2P Not in limits has occurred. " Restart "Internal System Error 0xe00a0426 IMAGING HV0N Not in limits has occurred. " Restart "Internal System Error 0xe00a0427 IMAGING HV0P Not in limits has occurred. " Restart "Internal System Error 0xe00a0428 IMAGING HVCW Not in limits has occurred. " Restart "Internal System Error 0xe00a0429 IMAGING HVPWR Not in limits has occurred. " Restart "Internal System Error 0xe00a042a IMAGING Multiple HV's Not in limits has occurred. " Restart "Internal System Error 0xe00a042b IMAGING EN_HV Inactive has occurred. " Restart "Internal System Error 0xe00a042c IMAGING PWR_GOOD_HV Inactive has occurred. " Restart "Internal System Error 0xe00a042d IMAGING LV_FAULT has occurred. " Restart

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Error Code Subsystem Message for Error log User Error Message Action on Action "Internal System Error 0xe00a042e IMAGING Failed to do CPLD sync has occurred. " Restart HV1N/HV2N/HVCW comparison error (bad "Internal System Error 0xe00a042f IMAGING command inputs) has occurred. " Restart HV limits check failed (bad "Internal System Error 0xe00a0430 IMAGING command inputs) has occurred. " Restart Failed to set DACs "Internal System Error 0xe00a0431 IMAGING (communication error) has occurred. " Restart "Internal System Error 0xe00a0432 IMAGING HV's aren't in regulation has occurred. " Restart Command not allowed in "Internal System Error 0xe00a0433 IMAGING present state has occurred. " Restart Command not allowed in "Internal System Error 0xe00a0434 IMAGING error state has occurred. " Restart "Internal System Error 0xe00a0435 IMAGING HV Alert unknown Error has occurred. " Restart "Internal System Error 0xe00a0436 IMAGING Received PFE Fault has occurred. " Restart Check HVInput - invalid Input parameters, see log "Internal System Error 0xe00a0437 IMAGING statement above has occurred. " Restart Timeout out waiting for In Regulation message after "Internal System Error 0xe00a0439 IMAGING setting HV's has occurred. " Restart PowerMicro timed-out "Internal System Error 0xe00a043a IMAGING waiting for HV in regulation has occurred. " Restart

THERMALSER Thermal Control Sensor "Thermal Sensor Error: 0xef050402 VICES Error shutting down system." Shutdown

THERMALSER Exceeded maximum system "System Temperature 0xef050404 VICES error count Limit exceeded." Shutdown "Battery Temperature THERMALSER Limit Exceeded. Replace 0xef050406 VICES Battery temperature error battery." Shutdown

THERMALSER "System Temperature 0xef050420 VICES PWR_HV over Temperature Limit exceeded." Shutdown

THERMALSER "System Temperature 0xef050421 VICES PWR_LV over Temperature Limit exceeded." Shutdown

THERMALSER PWR_TSUPR over "System Temperature 0xef050422 VICES Temperature Limit exceeded." Shutdown

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Error Code Subsystem Message for Error log User Error Message Action on Action

THERMALSER DIG_HYDRA over "System Temperature 0xef050423 VICES Temperature Limit exceeded." Shutdown

THERMALSER DIG_VSUPR over "System Temperature 0xef050424 VICES Temperature Limit exceeded." Shutdown

THERMALSER XMT_V5NA over "System Temperature 0xef050425 VICES Temperature Limit exceeded." Shutdown

THERMALSER XMT_VSUPR over "System Temperature 0xef050426 VICES Temperature Limit exceeded." Shutdown

THERMALSER "System Temperature 0xef050427 VICES RCV_ZIP over Temperature Limit exceeded." Shutdown

THERMALSER "System Temperature 0xef050428 VICES RCV_AFE over Temperature Limit exceeded." Shutdown

THERMALSER "System Temperature 0xef050429 VICES RCV_CW over Temperature Limit exceeded." Shutdown

THERMALSER "System Temperature 0xef05042a VICES RCV_LV over Temperature Limit exceeded." Shutdown

THERMALSER RCV_VSUPR2 over "System Temperature 0xef05042b VICES Temperature Limit exceeded." Shutdown

THERMALSER Multiple Sensors over "System Temperature 0xef05042c VICES Temperature Limit exceeded." Shutdown

THERMALSER Received Temp Alert with "System Temperature 0xef05043d VICES unknown error Limit exceeded." Shutdown

THERMALSER Failed to Set Temperature "Temperature Limit 0xef050440 VICES Limits Failure." Shutdown

THERMALSER PWR_HV Temperature "System Temperature 0xef050450 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER PWR_LV Temperature "System Temperature 0xef050451 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER PWR_TSUPR Temperature "System Temperature 0xef050453 VICES Sensor Error Sensor Failure." Shutdown

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Error Code Subsystem Message for Error log User Error Message Action on Action

THERMALSER DIG_HYDRA Temperature "System Temperature 0xef050453 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER DIG_VSUPR Temperature "System Temperature 0xef050454 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER XMT_V5NA Temperature "System Temperature 0xef050455 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER XMT_VSUPR Temperature "System Temperature 0xef050456 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER RCV_ZIP Temperature "System Temperature 0xef050457 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER RCV_AFE Temperature "System Temperature 0xef050458 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER RCV_CW Temperature "System Temperature 0xef050459 VICES Sensor Error Sensor Failure." Shutdown

THERMALSER RCV_LV Temperature "System Temperature 0xef05045a VICES Sensor Error Sensor Failure." Shutdown

THERMALSER RCV_VSUPR2 Temperature "System Temperature 0xef05045b VICES Sensor Error Sensor Failure." Shutdown "System Temperature THERMALSER PWR_HV sensor Sensor Communication 0xef050460 VICES communication error Error." Shutdown "System Temperature THERMALSER PWR_LV sensor Sensor Communication 0xef050461 VICES communication error Error." Shutdown "System Temperature THERMALSER PWR_TSUPR sensor Sensor Communication 0xef050462 VICES communication error Error." Shutdown "System Temperature THERMALSER DIG_HYDRA sensor Sensor Communication 0xef050463 VICES communication error Error." Shutdown "System Temperature THERMALSER DIG_VSUPR sensor Sensor Communication 0xef050464 VICES communication error Error." Shutdown "System Temperature THERMALSER XMT_V5NA sensor Sensor Communication 0xef050465 VICES communication error Error." Shutdown

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Error Code Subsystem Message for Error log User Error Message Action on Action "System Temperature THERMALSER XMT_VSUPR sensor Sensor Communication 0xef050466 VICES communication error Error." Shutdown "System Temperature THERMALSER RCV_AFE sensor Sensor Communication 0xef050468 VICES communication error Error." Shutdown "System Temperature THERMALSER RCV_CW sensor Sensor Communication 0xef050469 VICES communication error Error." Shutdown "System Temperature THERMALSER RCV_LV sensor Sensor Communication 0xef05046a VICES communication error Error." Shutdown "System Temperature THERMALSER RCV_VSUPR sensor Sensor Communication 0xef05046b VICES communication error Error." Shutdown

THERMALSER Multiple Temperature Sensor "System Temperature 0xef05046c VICES Error Sensor Failure." Shutdown

THERMALSER Temp Sensor Alert received "System Temperature 0xef05046d VICES with unknown error Sensor Failure." Shutdown

THERMALSER "Temperature Limit 0xef050470 VICES Failed read alert status Failure." Shutdown

THERMALSER "System fan Error: 0xef050480 VICES Fan is stuck Shutting down." Shutdown "Monitor Configuration Error: Please shutdown 0xef070401 DISPLAY DVI configuration failed system." Shutdown

FRONT_END_P "Internal System Error 0xef080401 OWER Low Voltage failure occurred has occurred. " Shutdown

FRONT_END_P Relay Voltage failure "Internal System Error 0xef080402 OWER occurred has occurred. " Shutdown

FRONT_END_P "Internal System Error 0xef080403 OWER 3.3 Voltage failure occurred has occurred. " Shutdown

FRONT_END_P V5_D Voltage failure "Internal System Error 0xef080404 OWER occurred has occurred. " Shutdown "Internal System Error 0xef0e0401 ROUTER Video Memory Test Failed has occurred. " Shutdown DCM LOCK Fault has "Internal System Error 0xef0e0402 ROUTER occurred has occurred. " Restart

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Error Code Subsystem Message for Error log User Error Message Action on Action Pipeline Fault Event "Internal System Error 0xef0f0000 ACQCONTROL Occurred has occurred. " Restart Post Power on check "Internal System Error 0xef0f0401 ACQCONTROL indicates faulty power circuit has occurred. " Restart Acq Programming Timeout Expired: Failed to complete "Internal System Error 0xef0f0403 ACQCONTROL programming sequence has occurred. " Restart "System Temperature 0xef0f0406 ACQCONTROL CW board over temperature Limit exceeded." Restart Operation Called with invalid "Internal System Error 0xef100404 UCM iterator has occurred. " Restart "Internal System Error 0xef100406 UCM Shutdown Imaging System has occurred. " Restart Freeze: Acquisition "Internal System Error 0xef100407 UCM Command has occurred. " Restart "Internal System Error 0xef100408 UCM Load Cine Loop has occurred. " Restart "Internal System Error 0xef100409 UCM Play Cine Frame Loop has occurred. " Restart "Internal System Error 0xef10040a UCM Store Cine Loop has occurred. " Restart "Internal System Error 0xef10040b UCM Get Image has occurred. " Restart Software install failed. Please "Software install failed. Re-install the system Please Re-install the 0xef100410 UCM software system software." Restart Software license expired. "Software license Please Re-install the system expired. Please Re-install 0xef100412 UCM software. the system software." Restart Software license expired. "Software license Please Re-install the system expired. Please Re-install 0xef100412 UCM software. "the system software." Restart Software license not "Software license not authorized for this release authorized for this release level. Contact system level. Contact system 0xef100413 UCM support. support." Restart Installed Software Release "Installed Software does not support cart. Release does not support 0xef100414 UCM Undock Scanner cart. Undock Scanner." Restart Failed to obtain device configuration for DICOM "Internal System Error 0xef104005 UCM image has occurred." Restart

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Battery Performance – Charge Times - Reconditioning

The following information is intended to provide an overview on the battery-driven system operation times and charging intervals for the Z-PAK battery pack. There are a number of variables that impact both the operating time and charge time, that must be taken into consideration when anticipating the performance of a specific battery. Cart battery packs are "consumable" items, and as such should be expected to have a gradual drop-off in performance (system operating time) over their life span. The system operating time numbers listed in this document are in reference to a "new" (optimum) battery. Charging times will be significantly impacted by the temperature of the battery pack at the time of the start of the charging cycle. The intelligent PIC device that manages the charging process will disable, or reduce the rate of charge, as dictated by the battery pack's current temperature. The total time that will be required for a battery to reach a full state of charge is impacted by a number of variables. These include: 1) Operating state of system (transducer in use: HV active) 2) Temperature of battery pack 3) Initial first-charge for Z-PAK:

Cart Battery Pack Performance: Typical system operation interval (on full charge): ...... up to 1.5 Hours Charging: Rapid Charge Rate (5A): ...... 5.0 hours (total) Step #1: ...... 3.0 hours – main charge Step #2: ...... 2.0 hours – final top-off charge

Trickle-Charge Rate (i.e., hot battery state) ...... 16.0 Hours (worst- case) Recondition & Full Charge State: Optimum (battery in cool state, and initial charge level near full) .... 8.0 Hours (total)

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Step #1: ...... 0 to 5 hours - to charge to full Step #2: ...... 2-3 hours - to fully discharge Step #3: ...... 4-6 hours - to fully recharge

Worst-case (battery in hot state, and initial charge level near zero) 14.0 Hours

How to Obtain MAC Address

Tools: None

Implementation: 1. Obtaining the MAC address from system logs Export Log Files 2. Find and open the “PMLogHistory.txt” file in the Log folder 3. The system MAC Address can be found a few lines underneath the “Postmortem” section of the logs (see image below).

I. Obtaining the MAC address from the ultrasound system MAC address is displayed on the Network page. Activate the Cursor and go to Setup in the bottom left corner and then click Network.

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II. Obtaining the MAC address for Wireless Bridge 1. Connect Wireless Bridge to laptop or desktop, open web browser and navigate to: 192.168.2.1. Log in by using: username: “dpac” password: “dpac” 2. MAC address of bridge is located in the Status menu, see image below.

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III. Obtaining the wireless bridge MAC address from product label:

The wireless bridge product lists an “ETH” and “WIFI” mac address, see image below. The “WIFI” MAC address is the one used when configuring the bridge on the customer’s network.

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Figure 18.8-ZS3

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19 Replacement Procedures

The procedures described in this section of the Service Manual should be performed ONLY by a Mindray/Zonare trained service personnel (Service Engineer, Biomed, etc.).

Recommended Tools

Tool Description Size Qty Where used Screwdriver, flat blade, medium tip, std. 3mm blade, 1 General use length 6” shaft, std. thick Screwdriver, Phillips, large tip, std #3, 6” shaft 1 Power supply module length Screwdriver, Phillips, med. tip std #2, 6” shaft 1 General Assembly length Screwdriver or Allen Wrench 4mm, 6” shaft 1 Power supply module, Dock, ZPAK Pliers, Diagonal Cutters, small Small jaws 1 General cutting of tie wraps, etc. Nut-Driver Set (U.S.) Multi-sizes 1 set Display Socket Wrench Set, (10mm, 13mm) Multi-sizes 1 set Gas spring (13mm) Allen Wrench Set (Metric) 2.5mm, 5mm Gas spring 4mm 1 Dock, ZPAK and Power Module Flashlight, Mini-Mag 6” size 1 Illuminating tight access areas Magnetic pick-up tool Telescoping 1 Retrieval of hardware Wrench (042-007605-00) 22mm& 1 Assembling and disassembling 36mm the caster

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ZS3 Module – Removal/Replacement

Identify the process for replacing the ZS3 Module. Overview of Procedure: • Remove Cosmetic Cover • Remove ZS3 Module • Replace ZS3 Module • Reassemble Cosmetic Cover • Verification of System Parts Required: • 115-051402-00 or 115-051400-00 ZS3 Module Equipment / Tools Required: • No Tools Required

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Open Chassis Cosmetics: 1. Ensure the system is powered “OFF”. 2. Place AC circuit breaker, located at the rear of the cart, in the “OFF” position.

Figure 19.1-ZS3 3. Disconnect the main AC power cord from the rear of the cart or unplug from the wall source. Ensure all USB and RJ45 connections removed from back of cart. 4. Ensure the cart wheels are in the locked position. 5. Wrap fingers under both bottom corners of plastic covering and pull until the covering is removed.

Figure 19.2-ZS3 Remove ZS3 Module: 1. Flip open metal flaps on either side of the chassis.

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Figure 19.3-ZS3 2. Turn each flap counterclockwise 90° so that each clasp is released. Move each clasp out of the slots on the sides of the chassis. 3. While holding the handles on the top and bottom of the ZS3 Module, pull until the ZS3 module is removed completely. Note: Place ZS3 Module with transducer ports up on a clean, dry surface. Replace ZS3 Module: 1. Align replacement ZS3 Module so that narrow end is on the bottom and top surface is below the convex plastic tab. 2. Push ZS3 Module into place. 3. Insert the clasps into the slots and tighten by turning the flaps clockwise. 4. Fold the flaps so that they are parallel to the sides of the ZS3 Module and the blue sides of the flaps are facing outward.

Figure 19.4-ZS3 Reassemble Cosmetics: 1. Align plastic covering so that transducer slots are aligned with transducer ports. The concave portion of the plastic covering should be partially covering the convex plastic tab on the cart. 2. Push plastic covering until it clicks into place.

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Verification of System: 1. Reconnect the main AC power cord from the rear of the cart or plug into the wall source. Reconnection and RJ45 connections to back of cart. 2. Place AC circuit breaker, located at the rear of the cart, in the “ON” position.

Figure 19.5-ZS3 3. Ensure the system is docked. 4. Turn the system on. 5. Attach a transducer (if not already connected) 6. Verify that the system is functioning correctly by performing a basic test. This test is comprised of the following: 7. Verify LCD display is functioning correctly by watching the boot and verifying that normal imaging is displayed after unit has fully booted. 8. Verify audio from the Display Assy – Enter PW, turn up the PW Gain and increase Volume. 9. Verify that the User Interface keys are functioning correctly. 10. Test USB ports on Main Board panel. 11. Test and Verify Network Connectivity (if applicable). 12. Test and Verify USB Peripheral Connectivity and Functionality (if applicable). 13. Once verification is complete, return system to normal operation.

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Casters – Removal/Replacement

Required Parts • 115-031572-00 Directional locking • 115-031746-00 Total locking

Required Tools/Equipment • Medium-tip flat blade screwdriver Overview of Procedure • Remove Caster • Set Brake and/or Swivel Lock position • Install Caster Removal of the Caster 1. Ensure the system is powered “OFF”. 2. Place AC circuit breaker, located at the rear of the system, in the “0” (Off) position.

Figure 19.6-ZS3 3. Disconnect the main AC power cord from the rear of the system. 4. Fold the LCD display screen down to a horizontal position, for protection from moving during tilting of Cart. 5. Lock the brake mechanism (front wheels) to keep the Cart from rolling. 6. While supporting the display/display arm from swinging to the side, on a soft surface (carpet, etc.) tilt the Cart forward, until it is horizontal, resting on the two front push handles for support

Caution: The Cart may be heavy and care should be taken while tilting forward, use two people if necessary to avoid injury. 7. Use the wrench in the accessory package to loosen and then remove the total locking caster. Unscrew the two M5 screws to remove the direction locking caster.

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You can use the same tools to replace the old casters with new ones in reverse order.

Figure 19.7-ZS3 Total locking caster removal and replacement

Figure 19.8-ZS3 Direction locking caster removal and replacement 8. Once installation is complete, Tilt the Cart back up onto its wheels, and release the brake mechanism. 9. Verify smooth operation and pivoting of the Cart through all movements. 10. Verify that the brake functions correctly and that each caster locks and the brake functions when it is set.

19” Display – Removal/Replacement

Required Parts

• 115-035481-00 Display Assy, ZS3

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Overview of Procedure

• Removal of Display Assy • Installation of Display Assy • Verification of LCD Display, Speakers, and

Required Tools/Equipment

• 9/32” Nut Driver or wrench • #1 Phillips Screwdriver Removal Procedure 1. Ensure the system is powered “OFF”. 2. Place AC circuit breaker, located at the rear of the system, in the “0” (OFF) position.

Figure 19.9-ZS3: System Circuit Breaker 3. Disconnect the main AC power cord from the rear of the system, or unplug from the wall source. 4. Remove the four (4) Phillips-head screws that are retaining the plastic display hinge back cover, and remove back cover and center insert sleeve.

Cable retention screw Figure 19.10-ZS3: Display Cover

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5. Remove the (6) Phillips-head screws that are retaining the larger plastic display hinge back cover, and remove cover.

Figure 19.11-ZS3 6. Remove the cover. 7. Disconnect the two cables on the upper right hand side (as shown below).

Figure 19.12-ZS3 8. Remove the four (4) 9/32” Nuts with captive washers that attach the display to the metal hinge assembly. Support the Display Assembly while loosening the last bolt. 9. Tilt the top of the display towards the rear of the cart to support the LCD Display while removing the last screw.

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10. Taking weight off the display, slide it off the threaded studs on the metal hinge assy. 11. Set the display aside.

Installation: 1. Reconnect the display cables to the connector on the display. 2. Slide the excess cable under the plastics and route in the same fashion prior to removal. 3. Align the display (4 threaded shafts) with the metal hinge. 4. Reinstall the 9/32” nuts and tighten. Ensure that the display cable is not pinched. 5. Reinstall the larger display cover by tightening the six (6) Phillips-head screws. 6. Reinsert the smaller display hinge plastic cover –

• Insert the bottom piece first, aligning the screw holes and secure the cable.

• Slide the top cover down. 7. Tighten the four (4) Phillips-head screws that are retaining the plastic display hinge back cover. System Verification: 1. Reconnect the main AC power cord from the rear of the system or plug into the wall source. 2. Place AC circuit breaker, located at the rear of the system, in the “1” (On) position.

Figure 19.13-ZS3 3. Ensure the system is docked in the cart. 4. Turn the system on. 5. Verify that the LCD display is functioning correctly by watching the boot sequence and verifying that normal imaging is displayed after system has fully booted. 6. Attach a transducer (if not already connected) and enable PW mode.

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7. Turn PW Gain up to obtain a filled in spectral trace with excess noise (this will generate white noise for the speakers). 8. Turn the Volume up (Clockwise) and verify that the white noise is audible from both speakers. 9. If possible – scanning with actual Doppler flow is ideal, but not required. 10. Once verification is complete, return system to normal operation.

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Display Arm – Removal/Replacement

Required Parts • 115-046667-00 Display Arm w/o Cable • Small tie-wraps (2)

Overview of Procedure • 19” Display - Removal/Replacement • Removal of the Display ARM • Installation of Display ARM • Verification of LCD Display, Speakers, and Microphone Required Tools/Equipment • Long handled flat-blade screwdriver (3mm width blade, 12” shaft, thin blade) • #2 Phillips Screwdriver – Stubby • #1 Phillips Screwdriver • 9/32” Nut Driver or wrench • 7/64” Allen Wrench • Wire Cutters Procedure Opening Chassis Cosmetics: 1. Ensure the system is powered “OFF”.

Figure 19.14-ZS3

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2. To remove the display cable from the netted stretch shielding through which it is routed (with other system cables) slide the netted stretch shielding together down its length, to cause the shielding to expand in diameter sufficiently to slide the Main Board end connectors out of the shielding. 3. Pay special attention to the routing (looping) and retention (cable tie) of the display cable, within the upper area of the main column of the system, in order to reproduce this layout during re-assembly. Display Removal: 1. Remove the four (4) Phillips-head screws that are retaining the plastic display hinge back cover, and remove cover and insert.

Figure 19.15-ZS3 2. Remove the (6) Phillips-head screws that are retaining the plastic display hinge back cover, and remove cover and insert. 3. Remove the tape securing the video cable to the display. 4. Grasp the connector housing and slide back to unlatch the cable from the video board.

Figure 19.16-ZS3

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5. Remove the four (4) 9/32” Nuts with captive washers that attach the display to the metal hinge assembly. Tilt the top of the display towards the rear of the cart to support the LCD Display while removing the last screw (See image below).

Figure 19.17-ZS3 6. Tilt the top of the display towards the rear of the cart to support the LCD Display while removing the last screw. 7. Slowly lift the Display off the metal hinge assy – while supporting it, gently remove the display cable from the display (this may need to be gently pried away with a screwdriver) 8. Once the cable is free, set the display aside and prepare for installation

Display Arm Removal: 1. Remove the four (4) 6mm Allen Head Bolts which hold the display arm to the chassis.

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Figure 19.18-ZS3 2. While gently pulling the video cable free from the system, remove arm assembly.

Display Arm Installation: 1. Route the display cables and ground cable down into the chassis of the system, allowing adequate slack in the required areas. 2. Secure the cables with tie-wraps, as per locations removed previously during the disassembly process. 3. Reinstall the four (4) 6mm Allen Head screws to secure the display arm to the chassis. Display Cables Reconnection

Figure 19.19-ZS3

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1. Reattach the display arm ground cable, and column ground cables to their mounting point on the bottom of the upper support plate, using the retaining screw. 2. Reconnect the Display’s power and video cables to the appropriate connectors on the Dock Board. 3. Secure the connector/cable with tape to the chassis, to ensure it does not come lose. 4. Secure cables in center column as shown below.

Figure 19.20-ZS3 5. Reassemble the Scanner Deck area, by reversing the removal procedure. 6. Slide the chassis cosmetic sleeve and insert panel back into place on their respective spring clips. Verification of Display, Speakers, and Microphone:

1. Reconnect the main AC power cord from the rear of the system or plug into the wall source. 2. Place AC circuit breaker, located at the rear of the system, in the “ON” position.

Figure 19.21-ZS3

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3. Ensure the module is docked in the system. 4. Energize the system. 5. Verify that the LCD display is functioning correctly by watching the boot and verifying that normal imaging is displayed after fully booted. 6. Attach a transducer (if not already connected) and enable PW mode. 7. Turn PW Gain up to obtain a filled in spectral trace with excess noise (this will generate white noise for the speakers) 8. Turn the Volume up (Clockwise) and verify that the white noise is audible from both speakers. 9. If possible – scanning with actual Doppler flow is ideal, but not required. 10. Verification is complete – return system to normal operation.

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Cart Battery – Removal/Replacement

Required Parts

• 115-066616-00 Assy, Battery Pack

Required Tools/Equipment

• #2 Phillips Screwdriver • 4mm Hex Key

Overview of Procedure

1. Removal Battery Pack 2. Re-installation of Battery Pack 3. Verification of system operation

Battery Pack Removal: 1. Place AC circuit breaker, located at the rear of the system, in the “OFF” position.

Figure 19.22-ZS3 2. Disconnect the main AC power cord from the rear of the system. 3. Put the User Interface in the highest position. 4. Set the front caster brakes to prevent system from rolling. 5. The Battery Pack is located under the system. Ensure that the display is in horizontal position. For the easiest access, tilt the entire system forward until is in horizontal position, resting on the front-side handles. Rest the front-side handles on foam or cardboard if available. 6. Remove the four (4) Phillips-head screws that are retaining the Battery Pack to the bottom of the system.

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Remove Second

Remove First

Loosen

Figure 19.22-ZS3 7. Remove the larger screw, located on the right side of the mounting of the Battery Pack to the bottom of the system (leaving the last two (2) screws, on the left side of the battery pack, still in place). 8. Slightly loosen (but DO NOT REMOVE) the remaining two (2) large screws (on the left side of the battery pack), while supporting the weight of the battery pack with your hand. 9. While still supporting the weight of the battery pack, slide it to the right to enable the slotted holes in the cover to come free from the last two mounting screws,

Figure 19.23-ZS3 10. Lower the battery pack slightly to enable access to the connector at the end of the battery pack power cable, and unplug the connector from the power supply on the system. 11. Remove the battery pack.

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Figure 19.24-ZS3 Battery Pack Re-Installation:

1. Insure the main AC power cord to the rear of the system is NOT connected to wall source. 2. While holding the battery pack in position, plug the power connector into the receptacle on the bottom of the power supply. 3. While still supporting the weight of the battery pack attach the power cable to the mating connector on the bottom side of the power supply module on the system.

Figure 19.25-ZS3 Warning: Be very careful to have the proper connector to socket orientation (note the rounded humps on one side, as shown below) when installing this cable. DO NOT FORCE connection, as this will damage connector and internal electronics.

Note rounded “hump” side alignment between connector and socket

4. While still supporting the weight of the battery pack, slide the slotted holes in the left side of the cover onto the two (2) loosened mounting screws on the left side of the power supply module. 5. Reinstall all mounting hardware to complete the installation.

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6. Before powering on the cart, please engage the two circuit breakers as follows: a. Push “in” the circuit breaker on the rear of the ZPAK b. Connect AC cord to cart and wall outlet. c. Flip the cart circuit breaker “on” by pushing in the “1”.

Figure 19.26-ZS3 System Verification: 1. Power on the system and perform a series of basic user operations, to verify normal system functionality. 2. Verify that the battery status ICON, on the upper-left corner of the display of the system, shows a current status. 3. Once verification is complete, return system to normal operation. Z-PAK “RECONDITION”: NOTE After installing a new battery pack, the calibration between the Z- PAK and the fuel gauge in the power supply module should be closely matched, and the time-consuming “Reconditioning” process should not need to be performed to achieve normal battery operated performance on the system. If the Z-PAK battery pack being installed is not a new item (older/reduced capacity cells), or there are any subsequent battery performance concerns after part replacement, perform the “Recondition” procedure described in Chapter 18 of this manual.

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Power Module – Removal/Replacement

Required Parts • P/N: 115-052756-00 Power Supply Module, ZS3

Overview of Procedure

Removal/Replacement of Power Supply Module System verification Required Tools • 4mm Allen Head Wrench • #1 Phillips Screwdriver Procedure Power Supply Module Removal: 1. Ensure the system is powered “OFF”. 2. Place AC circuit breaker, located at the rear of the system, in the “0” (OFF) position. 3. Disconnect the main AC power cord from the rear of the system or unplug from the wall source. 4. Put the User Interface in the highest position. 5. Set the front caster brakes to prevent system from rolling. 6. Cut any plastic tie-wraps that retain the AC power cable to the chassis, and free it from its mounting for later removal with the Power Supply Module. 7. The Power Supply Module is located under the system. Ensure that the display is in horizontal position. For the easiest access, tilt the system so it rests on the front handles, exposing the bottom of the unit. Rest the front-side handles on foam or cardboard if available.

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Remove six (6) of the eight (8) mounting screws as shown below.

Figure19.27-ZS3 8. Partially remove the lower two (2) mounting screws retaining the power module to the bottom of the system and allow them to help support supply while the cables are being disconnected.

Figure 19.28-ZS3 9. Gradually tilt the Power Supply Module approximately 3” to provide access for disconnecting the cabling.

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Figure 19.29-ZS3 10. Reach in and disconnect the five (5) cable connections. Note where each cable connects for reassembly (see figure for assistance).

Figure 19.30-ZS3

Figure 19.31-ZS3 NOTE: The cables marked above have a locking connector. You need to grasp the hood and slide towards you before pulling connector to disconnect.

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Figure 19.32-ZS3 11. Once the cables are free, set the Power Supply Module aside and prepare for installation. Installation: 1. Reconnect the cables to the replacement Power Supply Module. 2. Tuck cables back into chassis and position Power Supply Module for installation. 3. Reinstall the eight (8) screws. Ensure that the Power Supply Module is securely connected. 4. Reattach the AC power cord to the socket at the rear of the Power Supply Module. 5. Install battery per instructions if one exists. 6. Before powering on the cart, please engage the two circuit breakers as follows: a. Push “in” the circuit breaker on the rear of the ZPAK b. Connect AC Cord to cart and outlet c. Flip the cart circuit breaker “on” by pushing in the “1”.

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Figure 19.33-ZS3 7. Tilt system back onto the casters. System Verification: 1. With the ZS3 Module installed, the LEDs should be as follow: LED 1 will be “on” LED 2 will be blinking LED 3 will blink when battery starts charging. 2. Turn on the system. 3. Verify that the LCD display is functioning correctly by watching the boot and verifying that normal imaging is displayed after fully booted. 4. Attach a transducer (if not already connected) and enable PW mode. 5. Turn PW Gain up to obtain a filled in spectral trace with excess noise (this will generate white noise for the speakers) 6. Turn the Volume up (Clockwise) and verify that the white noise is audible from both speakers. 7. If possible – scanning with actual Doppler flow is ideal, but not required. 8. Go to Service page and click on Maintenance button. 9. Click on Cart Battery Status. 10. Verify that the battery is in rapid charge mode.

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User Interface – Removal/Replacement

Required Parts • 115-066351-00 ...... Assy, User Interface, ZS3 (Standard Version 7.6) Or 115-066352-00…………..Assy, User Interface, ZS3 (SP version) Or 115-066353-00………….. Assy, User Interface, ZS3 (Version 9.0) • 86596-00 ...... Trackball Assy (if replaced separately) • 86597-00/115-049358-00 QWERTY, Low profile, ZS3 (if changed separately)

Overview of Procedure

Removal and replacement of User Interface Assy System verification

Required Tools/Equipment

#1 Phillips Screwdriver

Procedure UI Removal/Replacement: 1. Ensure the system is powered “OFF”. 2. Place AC circuit breaker, located at the rear of the system, in the “0” (OFF) position.

Figure 19.34-ZS3 3. Disconnect the main AC power cord from the rear of the system or unplug from the wall source. 4. Remove the eight (8) Phillips screws that secure the UI to the cast UI base. This will need to be accomplished from below using a Phillips screwdriver.

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Figure 19.35-ZS3 M3X14 cross panhead screws(8)

5. While lifting the front of the User Interface up and exposing the underside of the UI, disconnect the USB and power cable from the UI assy.

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USB Cable

Power Cable

Figure 19.36-ZS3 6. Reverse the steps above to install the replacement User Interface.  If replacement of the trackball is required, proceed to Trackball Replacement steps prior to re-installing the User Interface (Refer to section below).  If replacement of the QWERTY keyboard is required, proceed to QWERTY Replacement steps prior to re-installing the User Interface (Refer to section below). Trackball Removal/Replacement: (if changed separately) 1. Ensure the User Interface is removed per steps 1 thru 5 of User Interface Removal Procedure above. 2. Push the 4 hooks inward in the square hole of the metal plate, pick up the trackball, unscrew the screws used for fixing the grounding cable, and then remove the trackball.

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Screw for fixing the Two hooks grounding cables

Two hooks

Figure 19.37-ZS3 3. When installing the trackball, lead the grounding cables through the bottom gap of the metal plate, align the socket interface with the side opening of the metal plate, push down the trackball until it clasps into the square holes of the metal plate, and use screws to fix the grounding cable to the metal plate.

Lead the grounding cable through the bottom gap of the metal plate

Figure 19.38-ZS3 4. Reinstall the User Interface assembly in reverse order of the removal steps listed above and proceed to System Verification.

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QWERTY Keyboard Removal/Replacement: (if changed separately) 1. Ensure the User Interface is removed per previous steps of User Interface Removal Procedure above. 2. Set the user interface (keys facing down) on a surface that will not damage the surface of the User Interface. 3. Disconnect the 2 flat cables and PCBA connection cable from the QWERTY Keyboard, unscrew the 2 screws, remove the backplane and back light, and then remove the QWERTY Keyboard.

Flat cables Connection cable

Screws

QWERTY Keyboard Back light

Backplane

Figure 19.39-ZS3 4. Reinstall in the QWERTY in reverse order. 5. Reinstall the User Interface Assy in reverse order of the removal steps listed above and proceed to System Verification. System Verification: 1. Reconnect the main AC power cord from the rear of the system or plug into the wall source. 2. Place AC circuit breaker, located at the rear of the system, in the “1” (ON) position.

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Figure 19.40-ZS3 3. Turn the system on. 4. Attach a transducer (if not already connected) 5. Verify that the System is functioning correctly by performing a basic test. This test is comprised of the following:

• Verify that the User Interface keys are functioning correctly by testing each of the keys.

• Verify that the Softkey OLED displays are correct and functioning correctly based on the selected mode.

• Verify the trackball functions correctly – testing both the horizontal and vertical axis. 6. Once verification is complete, return system to normal operation.

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Dock Board/SSD - Removal/Replacement

Required Parts

• 115-029534-00 Dock Board(FRU) • 115-029532-00 SSD 128G 2.5"(FRU)

Required Tools/Equipment

• 4mm Allen Head Wrench • Phillips 1 • Torx 10 • Torx 8

Overview of Procedure

Remove Module Open Cosmetics (for chassis access) Remove / Replace Dock Board/SSD System Verification

General Disassembly: 1. Ensure the system is powered “OFF”. 2. Place AC circuit breaker, located at the rear of the system, in the “0” (OFF) position.

Figure 19.46-ZS3

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3. Disconnect the main AC power cord from the rear of the system or unplug from the wall source. 4. The plastic covering and ZS3 Module should already be removed. Note: If the plastic covering and ZS3 Module are not yet removed, see "ZS3 Module – Removal/Replacement" to do so. 5. Firmly pushing the hooked connection at the top of the Dock Board towards the back of the cart. Once the hook is free, the plastic cover can slide up.

Hook

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Screws

Figure 19.47-ZS3 6. Locate the two screws on each bottom corner of the Dock Board. Unscrew the higher one on each side. 7. Unscrew each of the screws in the top corners of the Dock Board. The Dock Board is now free. 8. Disconnect all wires where they connect to the Dock Board. There are five wires in total. Take note of where each wire connects for reassembly

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Figure 19.49-ZS3 9. The Dock Board may now be removed completely from the cart

SSD Removal/Replacement 10. Remove the three Torx 10 screws to open the SSD enclusure.

Figure 19.50-ZS3 Dock board

11. Remove the 4 Torx 10/8 screws that hold the SSD in place.

Figure 19.51-ZS3

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12. Repeat all steps in reverse order to reassemble Dock Board/SSD. Reconnect all five wires as they were (See figure above). Replace ZS3 Module and plastic covering.

System Verification: 1. Reconnect the main AC power cord from the rear of the system or plug into the wall source. 2. Place AC circuit breaker, located at the rear of the system, in the “1” (ON) position.

Figure 19.52-ZS3 3. Ensure the module is docked and the cosmetic cover is on. LED #1 will blink quickly and LED #5 will remain on. 4. Turn the system on. 5. Attach a transducer (if not already connected) 6. Verify that the System is functioning correctly by performing a basic test. This test is comprised of the following:

• Verify LCD display is functioning correctly by watching the boot and verifying that normal imaging is displayed after fully booted.

• Verify Audio from the Display Assy – Enter PW, turn up the PW Gain and increase Volume

• Verify that the User Interface keys are functioning correctly

• Test USB ports on Main Board panel

• Test and Verify Network Connectivity (if applicable)

• Test and Verify USB Peripheral Connectivity and Functionality (if applicable) 7. Once verification is complete, return system to normal operation.

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Gas Spring – Removal/Replacement

Required Parts

• 033-000433-00 Assy, Gas Spring, Gen II Cart (with trigger)

Required Tools/Equipment

• #2 Phillips Screwdriver • 5mm Allen Hex wrench • 13mm socket, used on a ratcheting wrench • 9/32” Nut Driver or wrench

Prerequisite Procedures to Be Performed:

13. Main Power Supply Module - Removal

Overview of Procedure

14. Removal of gas spring 15. Re-installation of above items 16. Verification of system operation

Main Power Supply Removal:

17. Perform Main Power Supply Module Removal (NOTE: Refer to Main Power Supply Replacement Procedure in this manual)

Gas Spring Removal: 1. Using the side of the hand – firmly knock the side of the plastic cosmetic sleeve loose. There are 3 spring clips that retain it at the top. If it does not come free – gently use the flat blade screwdriver to pry the cosmetics loose (use tape on the blade to avoid marring the chassis surface).

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Spring Clips

Figure 19.53-ZS3 2. Slide the plastic cosmetic sleeve downward as far as it will go, letting it slide over the bottom panel insert.

3. Screw upward the stud bolt and screws, skip down the fixed column from the gas spring, remove the two retainer rings from the upper bolt, and remove the upper bolt. In this case, all the upper fixing parts of the gas spring are removed.

Stud bolt

Upper bolt

Fixed column Stud bolt and screws

Figure 19.54-ZS3

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4. Remove the lower bolt and screws from the bottom of the gas spring. In this case, the bottom fixing parts of the gas spring are removed, and the gas spring can be taken out from the stand column.

Lower bolt and screw

Figure 19.55-ZS3 5. Reinstall the gas spring in the reverse steps as shown above. During installation, adjust down the stud bolt of the gas spring and tighten the screws, to realize that the gas spring handle can normally control the up and down function of the system.

Screw

Stud bolt

Figure 19.56-ZS3 Gas spring & Power Supply Module Re-Installation: 1. Reverse all of the previous steps for installing the replacement gas spring, and re-installing the power supply module. System Verification:

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1. Reconnect the main AC power cord from the rear of the system or plug into the wall source. 2. Place AC circuit breaker, located at the rear of the system, in the “1” (ON) position. 3. Operate the lift mechanism through its full range to ensure proper gas spring operation. 4. Power on the system and perform a series of basic user operations, to verify normal system functionality. 5. Once verification is complete, return system to normal operation.

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20 Parts Catalog

1 Display

UI keyboard Accessories cover

Transducers User Interface

Module & Cart Internal Electronics Cabling

Power System Cart Misc

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System

Number Part Number Description

1. 88000-00 ZS3 Ultrasound System

Display

2

3 4

Figure 20.1-ZS3 Number Part Number Description

2. 115-035481-00 Display, 19” w/Overlay, ZS3

3. 009-005932-00 Cable, HDMI-Mini to HDMI-Mini, Latching, with magnet ring

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4. 009-005933-00 Cable, Power, Circular, Shielded, Latching, Cart, G3, L= 1.3m, with magnet ring

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Accessories

6 5 7

8 9

11 10

13 12

Figure 20.2-ZS3 Number Part Number Description

5. 043-004338-00 Tray

6. 043-008258-00 ZS3 Saddlebag(Left)(large)

7. 043-008259-00 ZS3 Saddlebag(Right(large)

8. 043-005873-00 Left gel bottle holder

9. 043-005874-00 Right gel bottle holder

10. 043-005875-00 Left transducer holder

11. 043-005876-00 Right transducer holder

12. 115-066623-00 USB Plug and Air Filter(FRU)

13. 023-001883-00 UI mode button

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Number Part number Description Picture

14. 84002-40 E9-4

15. 84003-30 L10-5

16. 84004-30 P4-1c

17. 84007-30 L8-3

18. 84008-30 L14-5sp

19. 84009-30 C6-2

20. 85222-30 C9-3

21. 86333-30 C4-1

22. 85333-30 L14-5W

23. 86888-30 C10-3

24. 85666-30 E9-3 - 3D Imaging

25. 85999-30 C8-3 – 3D Imaging

P8-3 TEE - 85888-30 26. TransEsophageal

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Number Part number Description Picture

27. 86000-00 A2CW – CW Doppler

28. 86111-00 A5CW – CW Doppler

29. 87222-00 L20-5

30. 87333-00 C9-3sp

31. 87666-00 P8-3m TEE

32. 87777-00 C6-1

33. 87555-00 C18-5

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Number Part number Description Picture

34. 87444-30 E9-3

35. 87150-00 L30-8

36. 89100-00 P7-3c

37. 89200-00 C12-4lp

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User Interface

38

41 42

40

Figure 20.3-ZS3 Number Part number Description 38. 115-066353-00 UI-ZS3 New-Port (FRU/9.x) 115-066352-00 UI ZS3-SP New-Port (FRU) 39. 115-066350-00 UI z.one.pro-SP New-Port (FRU/8.x) 40. 115-031747-00 Assy, Trackball Only, ZS3 41. 115-029536-00 Assy, Power Distribution (under UI) 115-025081-00 or USB HUB USB Hub, ZS3 (under UI) 42. 023-000817-00

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Module & Cart Electronics

50 52

44

Figure 20.4-ZS3 Number Part number Description 43. 115-058353-00 ZS3 Module Kit(ARFI,Without ECG/9.x) 44. 115-058354-00 ZS3 Module Kit(ARFI,Aux-ECG/9.x) 45. 115-066366-00 Scan Module No U-Disk (FRU) 46. 115-066365-00 Scan Module ECG No U-Disk (FRU) 47. 115-029534-00 Assy, Dock Board, ZS3 48. 115-029537-00 Assy, On/Off Board, ZS3 49. 115-029544-00 ON/OFF Button Board (FRU) Module Cover Assembly (FRU, Without 115-045637-00 50. ECG) Module Cover Assembly (FRU, With 115-045638-00 51. ECG) 52. 115-025083-00 Cover, Column, ZS3

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Internal Cabling

58

55 53 57

61 54 60 59

56

Number Part number Description Cable, Pwr Module to Dock Bd, Pwr, 009-004183-00 53. ZS3 Cable, Pwr Module to Dock Bd, Comm, 009-004181-00 54. ZS3 Cable, Pwr Module to On/Off, Comm, 009-004187-00 55. ZS3 Cable, Pwr Module to Pwr Dist Bd 009-004184-00 56. (PDB), Pwr ZS3 (2) 57. 009-004182-00 Cable, Dock Bd to Display, Video, ZS3 58. 009-004179-00 Cable, Dock Bd to UI, Comm, ZS3 59. 009-006119-01 Cable, UI to Printer, Video, ZS3 Cable, Pwr Dist Bd (PDB) to Display, 009-005933-00 60. Pwr, ZS3 Cable, Pwr Dist Bd (PDB) to UI, Pwr, 009-004188-00 61. ZS3

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Power Module

64 63 62

Figure 20.5-ZS3 Number Part number Description 62. 115-052756-00 Assy, Power Supply Module, ZS3 63. 115-032799-01 Cart Power Board(FRU/9.x) POWER SUPPLY BOARD 24V 115-032798-00 64. 250W(FRU)

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Miscellaneous Cart Items

66 65 67

Figure 20.6-ZS3 Number Part number Description 65. 115-031572-00 Straight Line Castor Assembly(ZS3) 66. 115-031746-00 ZS3 Total Locking Castor(FRU) 67. 033-000543-00 Gas Spring

Peripherals

Number Part number Description Pictures

68. 40013-00 SONY, UP-711MD B/W Printer

69. 40011-00 Bar Code Reader

70. 34597-00 USB Foot pedal

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Options and Upgrading Package

Number Part number Description Pictures

71. 115-061341-00 Echocardiography Option (9.x)

Field upgrade to Shared Service 115-061340-00 72. (8.x)

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Appendix A Phantom Usage Illustration

Targets Disposal of Phantom KS107BD A1——A5: Axial resolution target group B: Blind-area target group C: Longitudinal target group D: Horizontal target group E: Mimic tumor F: Mimic sac (diam 10mm) and stone G Mimic sac (diam 6mm) 4. Line Target System There are 8 groups of nylon line targets disposed as shown in the figure. 1.A1——A5: Axial and lateral resolution target group. The distances between the horizontal branch and the acoustic window are 30, 50, 70, 120 and 160mm, the center horizontal distances between two adjacent lines of A1 and A2 groups are 1, 5, 4, 3, 2mm, A3~A5 groups are 5, 4, 3, 2mm. The center longitudinal distances between two adjacent lines of the longitudinal branches are 4, 3, 2, 1mm. 2.B: Blind-area target group. Center horizontal distance of adjacent lines is 10mm, distances to the acoustic window are 10, 9, 8, 7, 6, 5, 4, 3mm. 3.C: Longitudinal target group. 19 target lines with a 10mm center distance between adjacent lines. 4.D: Horizontal target group. 7 target lines with a 20mm center distance between adjacent lines.

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Targets disposal- KS107BD A1——A4 Axial resolution target group B1——B4 Lateral resolution target group C Longitudinal target group D Horizontal target group E1——E3 Mimic sacs with diameters of 2, 4, 6mm 4. Line Target System There are 8 groups of line targets disposed in TM material as shown in the figure. 1.A1——A4: Axial resolution target group. The upmost lines in each target locate at the depth of 10, 30, 50, 70mm, the center longitudinal distances of each group (from the top down) are 3, 2, 1, 0.5mm, and the horizontal distance is 1mm. 2.B1——B4: Lateral resolution target group. Locate at a depth of 10, 30, 50, 70mm, with a center horizontal distance of 4, 3, 2, 1mm in each group. 3.C: Longitudinal target group. 12 target lines with a 10mm center distance between adjacent lines. 4.D: Horizontal target group. Locate at a depth of 40mm, with a 20mm center distance between adjacent lines.

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Appendix B Electrical Safety Inspection

The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations.

All tests can be performed using commercially available safety analyzer test equipment. These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe such as Fluke, Metron, or Gerb may require modifications to the procedure. Follow the instructions of the analyzer manufacturer.

The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step if an approved agency status is to be maintained. The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total current loads.

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ELECTRICAL SAFETY INSPECTION 1- Power Cord Plug

TEST PROCEDURE

 The Power Plug No broken or bent pin. No The Power Plug Pins discolored pins.

No physical damage to the plug The Plug Body body.

No physical damage to the strain relief. No plug warmth for device The Strain Relief in use.

No loose connections. The Power Plug

 The Power Cord No physical damage to the cord. No deterioration to the cord. --For devices with detachable power cords, inspect the The Power Cord connection at the device. --For devices with non-detachable power cords, inspect the strain relief at the device.

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ELECTRICAL SAFETY INSPECTION 2- Device Enclosure And Accessories

TEST PROCEDURE

 Visual Inspection No physical damage to the enclosure and accessories.

No physical damage to meters, switches, connectors, etc.

No residue of fluid spillage (e.g., The Enclosure and water, coffee, chemicals, etc.). Accessories No physical damage to probe head (e.g., crack)

No loose or missing parts (e.g., knobs, dials, terminals, etc.).

 Contextual Inspection

No unusual noises (e.g., a rattle inside the case).

No unusual smells (e.g., burning The Enclosure and or smoky smells, particularly from Accessories ventilation holes).

No taped notes that may suggest device deficiencies or operator concerns.

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ELECTRICAL SAFETY INSPECTION 3- Device Labeling

TEST PROCEDURE Check the labels provided by the manufacturer or the healthcare facility is present and legible.  Main Unit Label  Integrated Warning Labels  Slope and High Voltage Caution Label  Don’t Stress Label

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ELECTRICAL SAFETY INSPECTION 4- Protective Earth Resistance

VOERVIEW

Protective Earth Resistance is measured using the RED test lead attached to the DUT Protective Earth terminal or Protective Earth Metal enclosure or equipotential terminal. Select the test current by pressing SOFT KEY 3 to toggle between 1AMP, 10AMP, and 25AMP. The front panel outlet power is turned off for this test. The following conditions apply: L1 and L2 Open.

TEST PROCEDURE

 Prepare

1) First select the test current that will be used for performing the Protective Earth Resistance test by pressing AMPERES (SOFT KEY 3). 2) Connect the test lead(s) between the RED input jack and the GREEN input jack. 3) Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150 Ohms, it will store the reading and subtract it from all earth resistance readings taken at the calibrated current.

4) If the calibration fails, the previously stored readings will be used until a passing calibration has occurred.

 Warning

During Earth Resistance testing, the DUT must be plugged into the 601PRO front outlet. If the DUT fails Earth Resistance, discontinue tests and label the device defective.

 Perform the Test 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet. 2) Attach the 601PRO RED input lead to the device’s Protective Earth terminal or an exposed metal area.

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ELECTRICAL SAFETY INSPECTION 4- Protective Earth Resistance 3) Press shortcut key 3. The Protective Earth Resistance test is displayed. 4) Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected test current is displayed in the upper right corner of the display.

5) Press START TEST to start the test. The test current is applied while resistance and current readings are taken. This takes approximately 5 seconds. 6) Press the print data key at any time to generate a printout of the latest measurement(s).

 NOTE When "Over" is displayed for Ohms, this signifies that a valid measurement was not obtained because either an open connection was detected or that the measurement was not within range. Readings greater than 9.999 Ohms will be displayed as Over.

 Failure Once it reaches the limitation, stop using equipment. Check the protective earth connection between Protective Earth terminal and Protective Earth Metal enclosure and equipotential terminal; Retest and inform the Customer Service Engineer for analysis and disposal if still fail.

LIMITS

ALL COUNTRIES R = 0.2Ω Maximum

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ELECTRICAL SAFETY INSPECTION 5- Earth Leakage Test

OVERVIEW

Run an Earth Leakage test on the device being tested before performing any other leakage tests. Leakage current is measured the following ways: ♦ Earth Leakage Current, leakage current measured through DUT outlet Earth ♦ Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage current measured through DUT outlet Earth There is no need to attach a test lead; the 601PRO automatically connects the measuring device internally.

TEST PROCEDURE

 Perform the Test 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2) Attach the device's applied parts to the 601PRO applied part terminals if applicable. 3) Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins immediately:

 SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.  SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.  SOFT KEY 3 toggles the DUT outlet from L2 to No L2.  SOFT KEY 4 toggles the AP to Earth to No AP to Earth. 4) Press the print data key at any time to generate a printout of the latest measurement.

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ELECTRICAL SAFETY INSPECTION 5- Earth Leakage Test

Figure 1 Earth leakage test

 Failure Check any short-circuits of the Y capacitor on power unit. Replace a new one if any portion defective. Check any broken of the Power Unit. Replace a new one if any portion defective. Inspect mains wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect mains wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

LIMITS

UL60601-1: 300 μA Normal Condition 1000 μA Single Fault Condition IEC60601-1:: 500 μA Normal Condition 1000 μA Single Fault Condition

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ELECTRICAL SAFETY INSPECTION 6- Patient Leakage Current

OVERVIEW

Patient leakage currents are measured between a selected applied part and mains earth. All measurements may have either a true RMS or a DC-only response.

TEST PROCEDURE

 Prepare

Perform a calibration from the Mains on Applied Part menu. The following outlet conditions apply when performing this test: Normal Polarity, Earth Open, Outlet ON Normal Polarity, Outlet ON Normal Polarity, L2 Open, Outlet ON Reversed Polarity, Outlet ON Reversed Polarity, Earth Open, Outlet ON Reversed Polarity, L2 Open, Outlet ON

 Warning If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only.

 Perform the Test 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2) Attach the applied parts to the 601PRO's applied part terminals. 3) Press shortcut key 6. The Patient Leakage test is displayed, and the test begins immediately.

4) Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current. 5) Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO.

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ELECTRICAL SAFETY INSPECTION 6- Patient Leakage Current 6) Press the print data key at any time to generate a printout of the latest measurement.

Figure 2 patient leakage Current

 NOTE 1, In addition to Probes ,Patient leakage current test should be perform if ECG or PCG parts used; 2, If the current test standard being used does not include Patient Leakage DC readings, or the DC option is not enabled, then DC readings will not be available through the APPLIED PART SOFT KEY selections.

 Failure Check any broken of the Applied parts. Replace any defective one. Check any broken of the ECG/PCG module if used, Replace any defective one. Check any broken of the Power Unit. Replace a new one if any portion defective. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

LIMITS

All countries For BF ECG input and transducer

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ELECTRICAL SAFETY INSPECTION 6- Patient Leakage Current 100μA Normal Condition 500μA Single Fault Condition

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ELECTRICAL SAFETY INSPECTION 7- Mains on Applied Part Leakage

OVERVIEW

The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth. Measurements are taken with the test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions as indicated on the display. The following outlet conditions apply when performing the Mains on Applied Part test. Normal Polarity; Reversed Polarity

TEST PROCEDURE

 Prepare To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2). 1) Disconnect ALL patient leads, test leads, and DUT outlet connections. 2) Press CAL to begin calibration, as shown:

If the calibration fails, the previously stored readings will be used until a passing calibration has occurred. Also, the esc/stop key has no effect during calibration. 3) When the calibration is finished, the Mains on Applied Part test will reappear.  Warning

1) A 2-beep-per-second signal indicates high voltage present at the applied part terminals while a calibration is being performed. 2) High voltage is present at applied part terminals while measurements are being taken.  Performance 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601 2) Attach the applied parts to the 601PRO applied part terminals. 3) Attach the red terminal lead to a conductive part on the DUT enclosure.

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ELECTRICAL SAFETY INSPECTION 7- Mains on Applied Part Leakage 4) Press shortcut key 7. The Mains on Applied Part test is displayed.

5) Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS: 6) Press START TEST (SOFT KEY 1) to begin the test. 7) Press the print data key to generate a printout of the latest measurement.

Figure 3 Mains on Applied part leakage

 NOTE 1, In addition to Probes ,Patient leakage current test should be perform if ECG or PCG parts used; 2, If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only.

 Failure Check any broken of the Applied part. Replace any defective one. Check any broken of the ECG/PCG module if used, Replace any defective one. Check any broken of the Power Unit. Replace a new one if any portion defective. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console.

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ELECTRICAL SAFETY INSPECTION 7- Mains on Applied Part Leakage Inspect wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

LIMITS

All countries: For BF ECG input and transducer: 5000μA

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ELECTRICAL SAFETY INSPECTION 8- Patient Auxiliary Current

overview

Patient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks. All measurements may have either a true RMS or a DC-only response.

TEST PROCEDURE

 Prepare 1) From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2) Attach the patient leads to the 601PRO ECG jacks. 3) Define the Lead Types from the View Settings Option. 4) Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins immediately. Display values are continuously updated until another test is selected.

5) Press SOFT KEYS 1-4 to select leakage tests 6) Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current: 7) Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO: 8) Press the print data key at any time to generate a printout of the latest measurement.

Figure 4 patient Auxiliary Current

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ELECTRICAL SAFETY INSPECTION 8- Patient Auxiliary Current

 NOTE If the current test standard being used does not include Patient Auxiliary Current DC readings, or the DC option is not enabled, then DC readings will not be available through the APPLIED PART SOFT KEY selections.

 Failure Check any broken of the AC cable. Replace a new one if any portion defective. Check any broken of the enclosure. Replace any defective part. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. Inspect wiring for bad crimps, poor connections, or damage. If the leakage current measurement tests fail on a new unit and if situation cannot be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal.

LIMITS

All countries For BF ECG input and transducer 100μA Normal Condition 500μA Single Fault Condition

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ELECTRICAL SAFETY INSPECTION FORM (Class I equipment)

Overall assessment: □ Scheduled inspection Test item: 1, 2, 3 □ Unopened repair type Test item: 1, 2, 3 □ Opened repair type, not modify the power part Test item: 1, 2, 3, 4, 5 including transformer or patient circuit board □ Opened repair type, modify the power part Test item: 1, 2, 3, 4, 5, 6, 7, 8 including transformer or patient circuit board Location: Technician: Equipment: Control Number: Manufacturer: Model: SN: Measurement equipment /SN: Date of Calibration: Pass/Fai INSPECTION AND TESTING Limit l 1 Power Cord Plug 2 Device Enclosure and Accessories 3 Device Labeling 4 Protective Earth Resistance Ω Max 0.2 Ω

____μA Max: Normal condition(NC) NC: 300μA(refer to Earth UL60601-1) * 5 Leakage NC: 500μA(refer to ____μA IEC60601-1) * Single Fault condition(SFC) SFC: 1000μA

Patient Normal condition(NC) □BF___μA Max: 6 Leakage BF applied part: Current Single Fault condition(SFC) □BF___μA NC:100μA, SFC: 500μA Max: 7 Mains on Applied Part Leakage □BF___μA BF applied part: 5000μA Patient Normal condition(NC) □BF___μA Max: Auxiliary 8 BF applied part: Leakage Single Fault □BF___μA NC:100μA, SFC: 500μA Current condition(SFC)

NOTE: The equipment which sell to America shall comply with the requirement of UL60601-1, others shall comply with the requirement of IEC60601-1. Name/ Signature: ______Date:______

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Revision History

Document Title: ZS3 Service Manual

Revision Revision Description of Change (Revision History) Author (s) Date 1.0 Initial Release Jiang Yunjun 2019/01/08 2.0 Adding Echocardiography Option (FRU) Jiang Yunjun 2019/07/05 Updating battery, air filter, USB plug, UI and scan module FRUs; 3.0 Adding procedures on upgrading 6.x/7/x to 9.x; Jiang Yunjun 2019/12/05 Adding instructions on installing intracavitary holders. Adding 3 new probes, and update the recovery 4.0 Jiang Yunjun 2020/01/10 content. 5.0 Updating the new-port UI FRU Jiang Yunjun 2020/04/22 6.0 Updating FRUs Jiang Yunjun 2020/09/30 7.0 Updating the battery module FRU Jiang Yunjun 2020/12/18 8.0 Updating FRUs Jiang Yunjun Document Owner: Manual Team

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P/N: 046-014026-00 (8.0)