7G-5A Medical Molecular Sieve Generator

User Manual

Before using the product, please read carefully the user manual Contents

1. Safety instructions ...... 1 1.1 Transportation and storage conditions ...... 1 1.2 Technical services and assistance ...... 1 1.3 Scope of liability ...... 1 1.4 Work environment requirements ...... 2 1.5 Operation and user notices ...... 3 1.6 Meanings of graphics and symbols ...... 4 1.7 Operator training ...... 4 1.8 Use scope and purpose ...... 5 1.9 Main performances and technical parameters ...... 5 2. Working principle and explanation ...... 6 2.1 swing (PSA) technology ...... 6 2.2 Oxygen process description ...... 6 2.3 Schematic diagram ...... 6 2.4 Product structure ...... 7 3. Installation instructions ...... 8 3.1 Typical installation schematic: ...... 8 3.2 Installation device description ...... 9 3.3 Device installation ...... 10 3.4 Device grounding protection requirements ...... 10 3.5 Special notes ...... 10 4. Operation instructions ...... 11 4.1 Operation panel ...... 11 4.2 Pre-start check ...... 12 4.3 Start procedures ...... 12 4.4 Operation status scanning ...... 12 4.5 Shutdown procedures ...... 12 4.6 Automatic standby and start ...... 13 4.7 Emergency troubleshooting ...... 13 4.8 Operation precautions ...... 13 4.9 Touch screen description ...... 14 4.10 PLC cabinet layout schematic ...... 17 5. Comprehensive maintenance guide ...... 18 5.1 Maintenance notices ...... 18 5.2 Operation and maintenance prompts ...... 19 5.3 Routine maintenance ...... 19 5.4 Regular maintenance ...... 20 5.5 Regular maintenance items and schedule ...... 21 5.6 Accessories ...... 24 6. Fault diagnosis and troubleshooting ...... 25 6.1 Causes and of common faults ...... 25 6.2 Emergency troubleshooting ...... 28 6.3 Power-off alarm ...... 28 6.4 Emergency measures ...... 28 6.5 Precautions ...... 29 7. Other notes ...... 30 8. After-sales services ...... 31 9. List of annexes ...... 32

The right of technical and appearance changes for the product is reserved, and any change will not be noticed!

1. Safety instructions

1.1 Transportation and storage conditions During the transport and storage processes, the effective measures about anti-inversion, sun-proof, rain-proof, anti-collision, anti-pollution and anti-corruption should be taken for the medical molecular sieve oxygen generator.

Environmental requirement: -40℃ ~ +55℃ Relative : < 80%, no condensation

Atmospheric pressure requirement: 86kPa ~ 106kPa

(1) The medical molecular sieve oxygen generator should be stored in the environment Note: without corrosive gases and strong electromagnetic field. (2) The storage temperature for PLC must be above -20℃, and the storage temperature for the touch screen must be above -10℃.

1.2 Technical services and assistance As the medical molecular sieve oxygen generator user manual from our company, this manual includes our customer service commitments, oxygen generator operation, installation, operation and maintenance and etc. Our purpose is to enable customers to satisfy our products and services, and we expect that this manual can provide you with the appropriate technical assistance. If you can not find the information you need in the manual, or you have other questions about our product, you are welcome to contact us directly. We will be happy to serve you, and give you the fastest response.

1.3 Scope of liability ► The contents contained in the manual are the technical secrets in our company, without the prior written approval from our company, the manual can not be copied or used for purposes outside of the device (product) use guide. ► The technical data, device operation and maintenance instructions contained in this manual cover all the works required for user normal operation and maintenance. But, any large maintenance or repair is not contained in the manual, and it should be performed by the maintenance department or authorized unit from out company. ► Unless otherwise indicated, any content in this manual does no imply any commitment to the product. Any of the terms and conditions related to sales and after-sales services for the product should follow the standard sale terms and conditions of such products, as well as agreement between the user and our company.

Note: The product provided by our company is based on the proven technologies and recognized safety regulations, applies only to the uses under normal circumstances and has achieved the desired design uses. Any improper use of the product may cause an incalculable damage or consequence for the consumer or a third party.

1 Safety instructions

► This product can not be used in the following situations: 1) On places outside the application scope of the device without permission; 2) In unintended use environment or application scopes; 3) Uses with unintended methods; 4) Unapproved parts used on the device; 5) Any safety part or control part is missed or expired; 6) Without permission, the control system or the control valve is changed; 7) Other situations that are non-compliance with safety regulations or requirements.

Note: Before use, operation, maintenance, and maintenance of this device, the user should be sure to carefully read the user manual!

1.4 Work environment requirements ► Environmental temperature range: 5℃ ~ 40℃ Relative humidity range: ≤80%, no condensation range: 86kPa ~106kPa

Note: Our company will not be responsible for any problem occurred during the device operation at outdoor within the temperature range! ► Air feeding requirements: A. The temperature of compressed air fed into the oxygen generator should not be higher than 40℃ or lower than 5℃; if it can not be within this temperature range, the efficiency of oxygen preparation will be reduced, or even the oxygen generator may fail within a certain time; B. It can improve the efficiency of oxygen generator and extend its service life to install a secondary cooling device or a cold and dry machine between the air compressor and the oxygen generator; C. The oil content, moisture content, and scales out from the air compressor should be as little as possible, to ensure the long-time trouble-free operation of the medical molecular sieve oxygen generator. The air compressor is an important part during the oxygen concentrating process, and it should be maintained according to the requirements in its instruction, to ensure that appropriate air quality. ► This device should be installed indoor, with a flat and clean ground and good air, and there should be no flammable, explosive and volatile matters, open fire, grease, flammable and explosive gas and heat sources around the device; ► The device is controlled by microcomputer, and it may not be operated normally in the condition of strong magnetic field interference, so it can not be installed away from the strong magnetic field, and the distance should ensure that the normal operation of the device can not be interfered by the magnetic field; ► Some explosion measures should be taken for the interior lighting and other electrical devices, to avoid any exposed electric spark; ► When the device is installed, there should be a sufficient space of above 0.8m around it, to ensure good ventilation for the device, for the operation, maintenance and repair from the operator; ► The air compressor and cold and dry machine should be kept in a well ventilated place;

2 Safety instructions

► The exhaust port should be placed on outdoor place where humans and animals can not be exposed, in order to avoid the exhaust damage to humans and animals; ► There should be no matters piled at the intake port of the air compressor and the exhaust port of the muffler, to ensure the unobstructed intake and exhaust; ► As the air compressor will generate a lot of heat during its operation, it is recommend to install an air conditioning indoor, to maintain the device operation under the normal environment pressure and temperature.

1.5 Operation and user notices ► The oxygen ball valve should be opened and closed lightly, in order to avoid any fire or explosion due to the adiabatic compression of the oxygen; ► The oxygen in the containers or pipeline can not be released directly toward any body, because the clothes immersed with the oxygen may be ignited by a spark, resulting in an intense burning; ► The supplied for the oxygen generator is relatively high, which may cause an overheating of the too long cable and form a fire near the heat sources of the oxygen generator, so the oxygen generator can not be supplied with the extended cable. It is very important for the safe operation of oxygen generator to use a well-grounded single contactor; ► In some important applications, the oxygen should be reserved, and the oxygen generator can not be directly connected to any oxygen storage device, because it is driven by the electric power system; once the power supply fails, the oxygen will be concentrated, and the reserved oxygen storage device can not also supply successfully the oxygen; ► To prevent the oxygen supply failure due to any downtime caused by a power-off or device failure, when necessary, the integrated supply bus or other oxygen supply devices (such as oxygen bottle, oxygen bag, etc.) can be used for those in urgent need of oxygen and critical patients. ► Prior to delivery, the product has been adjusted under its best status by the manufacturer; after delivery, the valve, control procedure and etc. on the device can not be adjusted, so as not to impact on the device performances; ► Do not frequently start and stop the device, the duration from its power-off to restart should be at least 15min, so as not to start the air compressor under certain pressure, to impact the service life of device; ► Any failure on the oxygen generator must be repaired by the designated personnel from the designated institution, other than the user himself, in order to avoid any damage from improper operation; ► After The device installation is complete, it can not be disassembled, so as not to cause any improper device operation or injury; ► The power supply parts part on the oxygen generator can only be demolished by professionals; ► Do not touch or close to the high-speed rotating parts; ► Any person can not be allowed to stand at the device inlet and exhaust ports, so as to avoid any injury; ► The ball valve and other devices should be switched on/off lightly, to avoid any shock or damage from the excessive pressure; ► During its maintenance process, be sure to pay attention to warning labels on the device.

3 Safety instructions

1.6 Meanings of graphics and symbols The symbols and their meanings about the safety requirements on the device are shown in the following table:

Graphical symbols Meanings Graphical symbols Meanings

NOTE! See the attached Protective grounding document.

Fragile items No raining

Up No upside down

No stacking No smoking

Air flow direction Oxygen flow direction

Exhaust gas Exhaust gas flow direction 93% Oxygen Oxygen storage tank

Any improper use may result Any improper use may result

Note in personal injury or property Warning in personal injury or property damage damage

1.7 Operator training ► After delivery of the device, our company will perform the operation and maintenance training for the operator, and only those have passed the corresponding exam can operate and maintain the device. Our company is not responsible for device damage, personal injury and other losses due to improper operation. ► The training contents are mainly based on this manual and some relevant technical documents; ► After delivery of the device, the operation and maintenance training for the users should include the specific operations, demonstration and other actions to provide the users a good understanding of the contents and requirements in this user manual.

4 Safety instructions

1.8 Use scope and purpose The medical molecular sieve oxygen generator is used as an oxygen source supplied for the oxygen supply system in medical center. The oxygen generator is designed for the medical and health care, with a molecular sieve as its adsorbent and with the pressure swing adsorption (PSA) method for oxygen concentration. The device is mainly used as an oxygen source in construction, expansion and renovation of the central oxygen supply system in hospital, and it can transmit the oxygen source to each indoor oxygen terminal through the pressure relief device and the pipeline for the medical use.

1.9 Main performances and technical parameters ► Product model description:

Design No. Design Number: oxygen output capability (Nm3/h) Medical molecular sieve oxygen concentrator

► Main performance parameters:

Oxygen production: 5Nm3/h Rated power: 11kVA

Oxygen concentration: ≥90% Power frequency: 50Hz ± 1Hz

Power supply voltage: III-phase AC 380V ± 38V, I-phase AC 220V ± 22V

Noise level: ≤85dB (A) Safety Class: Class I

Operation mode: continuous operation Protection class: IPX0

5 2. Working principle and explanation

2. Working principle and explanation

2.1 Pressure swing adsorption (PSA) technology The medical molecular sieve oxygen generator from our company can be used to prepare the oxygen according to the user requirement, and it has low energy consumption, rapid oxygen production, low cost, safe and reliable use, simple operation, easy maintenance and other advantages. With the pressure swing adsorption (PSA) method and with the molecular sieve as the adsorbent, the device can separate the oxygen and the nitrogen in the air, and filter out the harmful substances, to prepare the high purity oxygen in line with the requirements in the medical standards.

2.2 Oxygen concentration process description In the medical molecular sieve oxygen generator, with the air as its raw material, with zeolite molecular sieve as its adsorbent, with the pressure swing adsorption (PSA) technology, the oxygen and the nitrogen in the air can be selectively adsorbed by the zeolite molecular sieve filled with small pores. After the air is compressed by the air compressor, through the processes of dust removal, degreasing and drying, it enters into the air tank, and then into the left adsorption tower; the pressure in the tower is increased, enable the nitrogen molecules in the air to be absorbed in the zeolite molecular sieve and the oxygen that is not adsorbed passes through the absorption bed and into the oxygen buffer tank; the above process is called as the left absorption. After the left absorption process is completed, the compressed air enters into the right adsorption tower, in which the nitrogen in the compressed air is absorbed by the zeolite molecular sieve, and the oxygen enriched enters into the oxygen buffer tank; this process is called as the right absorption. At the same time, the nitrogen absorbed by the zeolite molecular sieve in the left adsorption tower is desorbed and discharged to the atmosphere. Conversely, when the absorption operation is performed in the left tower, the adsorption operation is performed in the right tower; with this continues cycles, the oxygen can be prepared.

2.3 Schematic diagram Drying and Remove the Oil-water cooling impurities Compresse separation Clean air d air Air raw Air separation Nitrogen-oxygen Pre-filter Cooling and material compressor drying machine Precision filter Air tank

Dust removal and sterilization Oxygen Oxygen buffer Adsorption Oxygen tank Filter

Oxygen supply Booster tank tower terminal

Booster Filter Integrated Exhaust gas supply bus

Medical molecular sieve oxygen generator schematic

6 Working principle and explanation

2.4 Product structure The medical molecular sieve oxygen generator is mainly composed of air source, oxygen-nitrogen adsorption and separation system, control system, oxygen detection system and gas filtration system. ► Air source: is composed mainly of air compressor, cooling and drying machine, precision filter and air tank; ► Oxygen-nitrogen adsorption and separation system: is the core of the oxygen generator, and is composed mainly of adsorption towers, control valves and oxygen buffer tank; ► Control system: is the nerve center of the oxygen generator, and is composed mainly of PLC, touch screen, solenoid valves and other electrical parts; ► Oxygen detection system: is composed of glass rotor flowmeter and pressure sensor (also equipped with an oxygen monitor based on the user need); ► Air filtration system: is composed of dust filter and disinfection filter, to achieve the oxygen post-purification.

7 3. Installation instructions

3. Installation instructions

3.1 Typical installation schematic:

Oxygen outlet

A. Screw-type air compressor integrated with cooling and drying functions B. Filter C. Air tank D. Oxygen concentrator E. Oxygen buffer tank F. Oxygen booster pump (booster) G. Oxygen tank

Note: The above installation schematic may vary with different models of oxygen generator and the different customer requirements for oxygen generator.

8 Installation instructions

3.2 Installation device description A. Screw-type air compressor integrated with cooling and drying functions ► The air compressor is the power source of the medical molecular sieve oxygen generator, which is used to provide the raw material for the oxygen generator, i.e. the compressed air, so it consumes a large ratio of the power for the oxygen generator. The selection of an efficient air compressor can save the costs; it the air compressor efficiency is increased by 1%, the annual energy cost can be saved by about 10,000RMB. Compared with the piston type air compressor, the screw type compressor has small volume, energy-saving, low noise, reliable and other advantages, so it is the preferred type configured on the oxygen generator. ► The cooling and drying machine is used to reduce the exhaust temperature from the air compressor, to cool the water vapor into the water, which will be discharged downstream from the gas-water separator. At the same time, a lower air temperature is more conducive to play the adsorption effectiveness of the molecular sieve. B. Filter An excessive amount of oil and water contained in the compressed air would seriously undermine the absorption capacity of the molecular sieve, even loss the absorption capacity, therefore, the compressed air must be cleaned for free of oil and water before entering into the absorption canister. The oxygen generator from our company uses four-level precision filter, with the filtration accuracy of 0.01um, to ensure that the quality of the compressed air can meet the requirements of the air source standards. C. Air tank PSA is a process with different air consumption, and an air tank with a proper capacity is equipped to maintain a quite stable air supply pressure. While the air temperature in the air tank may be reduced appropriately for water vapor condensing, to further optimize the air compositions. D. Oxygen generator The medical molecular sieve oxygen generator uses double-tower PSA process for oxygen concentration and the oxygen generator is the core device of the oxygen concentration system, which uses PSA technology to separate the oxygen from the compressed air, to achieve the oxygen with the purity of 93±3% for use. All solenoid valves are the “Heart” of PSA oxygen generator and they control the operation of the oxygen generator with the predetermined process and time. E. Oxygen buffer tank The oxygen flow from the oxygen generator will change throughout the whole PSA cycle, and an appropriate oxygen buffer tank should be equipped to ensure a smooth oxygen output. F. Oxygen booster pump It is used to improve the oxygen storage pressure inside the oxygen tank, in order to meet various clinical needs of oxygen supply pressure at the oxygen terminals, and it is necessary to equip an appropriate oxygen booster pump for the oxygen supply system. G. Oxygen tank Since there is dramatic change of the hospital oxygen consumption in different duration every day, an oxygen tank with appropriate capacity should be equipped to ensure a stable oxygen supply pressure and a continuous oxygen supply.

9 Installation instructions

3.3 Device installation ► The medical molecular sieve oxygen generator provided by our company should be installed on-site by its manufacturer, cooperated and assisted by the user; after all the devices are installed in place, the connection pipeline among the devices should be installed on base of the on-site configuration. The pipeline should be connected by the construction professionals, to ensure no leakage; ► The company’s personnel should perform the first start of the medical molecular sieve oxygen generator, and check and confirm the product performances according to the requirements; ► After the on-site installation, commissioning and trial operation of the oxygen generator are qualified, it can be delivered to the user for acceptance and use; ► The oxygen generator should be installed according to the requirements in relevant technical standards and the design drawings.

3.4 Device grounding protection requirements ► Grounding protection: When the operator turns on and off the power supply, the grounding protection line must be connected before the power supply is turned on and must be disconnected before the power supply is turned off. ► Grounding protection line requirements: Line diameter requirements: ≥ 10mm2 Color requirements: Standard yellow-green along the whole length

Note: The grounding protection measures should be taken for all metal casings for the electrical parts on the molecular sieve oxygen generator; when the oxygen generator is installed and used, be sure that the total grounding measure of the oxygen generator can be connected reliably to the special grounding device.

3.5 Special notes

Warning: Before this device is used, you must first carefully read all contents in the device manual; only you have comprehensively understood the relevant knowledge, you can install and operate the device. Do not install, use and store the device under the following conditions: ► Water or damp places; ► Places under high-temperature, no-ventilation, sunlight, dust, salty air environment; ► Places where the device may be tilted, vibrated, shocked; ► Places for chemical storage and with corrosive gases; ► Places with more oils and gases; ► Places with strong electromagnetic interference; ► Places with high-traffics; ► Places where the children may access; ► Places where the device may be impacted or damaged.

10 4. Operation instructions

4 Operation instructions

4.1 Operation panel

January 6, 2014 10: 22: 38 Monday

Jiangsu Yuwell Medical Device Co., Ltd.

● Enter the main interface

Operation panel schematic Explanations in the note ① Touch screen ② Emergency stop button (red) ③ Stop button (red) ④ Reset button (blue) ⑤ Start button (green)

11 Operation instructions

4.2 Pre-start check ► Check whether the environmental temperature and humidity can meet the requirements; ► Check whether there is clean and free of foreign matters at intake and exhaust ports on the device and the parts; ► Check whether each drain pipeline is unobstructed; ► Make sure that the power line is connected reliably and all parts are under the normal status; ► Check the piping connections for loosening or disconnection; ► Confirm that the manual valve in pipeline is opened or closed properly.

4.3 Start procedures ► Turn on the power switch; ► Turn the power supply for the air compressor; press the start button on the air compressor to maintain it in standby mode; ► Turn on the power supply on the oxygen booster pump; turn on the start switch on the oxygen booster pump to maintain it in standby mode; ► Turn on the power supply on the oxygen generator; when the green “Start” button on the control panel is pressed, since the control program for all device starts has be set in the system, the air compressor, the oxygen generator and the oxygen booster pump will be started sequentially, the device will enter into the automatic operation mode with the predetermined oxygen production, and the oxygen with concentration of >90% will be provided normally after 30min.

4.4 Operation status scanning ► There is a display on the touch screen of the control panel, to indicate whether the power input is normal; ► When the device is first started, an alarm prompt will be displayed on the touch screen sometimes, you can enter into the alarm information interface for query; for example, the alarm of “the pressure in the oxygen tank is low” indicates that the pressure in the oxygen tank can not meet the requirements, which do not affect the operation of the oxygen generator, and the alarm information will be automatically eliminated after the system operation for some time and the pressure in the oxygen tank is higher than the set alarm pressure; ► The touch screen on the control panel can display the operation status of the air compressor and the oxygen generator and the pressure in the oxygen tank during the oxygen concentration, enable the operator to monitor the system operation status, and timely perform inspection, maintenance, and repair in case of any abnormity.

4.5 Shutdown procedures ► Shut off the output valve on the oxygen tank, to enable the oxygen not to enter into the user terminals; if the oxygen is not used, the above operation can maintain the oxygen in the tank at a constant pressure; ► Store the oxygen under the automatic mode of the medical molecular sieve oxygen generator, to achieve the oxygen pressure in the tank at the set upper pressure limit; ► Press the red “Stop” button on the control panel (or click “Stop” button on the touch screen), the oxygen generator will enter into the shutdown status, to turn off the mains on the oxygen generator; ► Press the stop button on the air compressor, to turn off the power supply for the compressor power;

12 Operation instructions

► Turn off the start switch on the oxygen booster pump, to turn off the power supply for the oxygen booster pump; ► If the medical molecular sieve oxygen generator is not used long-term, turn off the main power switch.

4.6 Automatic standby and start ► Auto standby: When the pressure oxygen tank rises to the set upper limit pressure, the device will stop the oxygen supply to the oxygen tank and automatically enter into the standby mode, without manual operation; ► Automatic start: In standby mode, if the pressure in the oxygen tank drops to the set lower limit pressure, the device will automatically be started, to supply the oxygen to the oxygen tank.

Note: If the device has a downtime due to any abnormity or fault, an alarm message will be displayed on the touch screen, which should be handled by the trained professional in accordance with Exception handling requirements specified by the manufacturer.

4.7 Emergency troubleshooting

Note: If the operator finds a device failure, the following measures should be taken immediately:

1. Click the red “Stop” button on the control panel, and the device immediately enters into the shutdown status; 2. Turn off the power switches on the air compressor and the oxygen booster pump; 3. Turn off the power supply on the control cabinet to enable the device to enter into the shutdown status and then perform the maintenance procedures.

4.8 Operation precautions ► When the device is under the normal operation, it does not require any additional adjustment and operation, the operator is only required to monitor the operation parameters and check the operation of the device; ► A sudden power outage can cause the device downtime; if the operator finds a power outage, he should immediately turn off the power switch, and can re-start the device in accordance with the start procedures after the power supply recovery; ►If the power outage time is longer, the device safety inspection should be performed before re-start; ► Notes about the touch screen: A. Do not use a sharp object to touch the touch screen; B. Keep the touch screen surface clean, and free of any foreign matter. ► Some requirements and regulations for operator: A. The operator must perform the proper operations in strict accordance with the device requirements in the user manual; B. The operator must be familiar with the related fire-fighting knowledge and can properly use the appropriate fire-fighting devices; C. The operator must operate the device carefully and can not be absent from his duty; D. The operator must fill completely in the daily record sheet, to provide a convenience for later maintenance

13 Operation instructions and repair; E. “Device Room” must be kept clean, and the routine maintenance for device must be performed; F. Any unrelated personnel can not enter into or stay in “Device Room”; G. Any debris or flammable material can not stacked in “Device Room”.

4.9 Touch screen description After the main power supply for the medical molecular sieve oxygen generator is turned on, the touch screen will automatically be started, to display the initial interface, as shown in Fig.1:

January 6, 2014 10: 22: 38 Monday

Jiangsu Yuwell Medical Device Co., Ltd.

● Enter the main interface

Fig. 1 - Initial interface ► After waiting for 3s, or manually clicking “Enter the main interface” button (in gray area), to enter the main interface on the oxygen generator, as shown in Fig. 2. The whole functions on the screen can be seen, including six functional blocks of “Device monitor”, “Parameter settings”, “Maintenance and commissioning”, “Alarm inquiry”, “Help” and “About us”.

January 6, 2014

Monday

Maintenance and Unit monitoring Parameter settings debugging

Return Alarm query Help About us

Copyright: Jiangsu Yuwell Medical Device Co., Ltd.

14 Operation instructions

Fig. 2 - Main interface ► If clicking the unit monitor icon on the interface, the screen will enter the monitoring interface of main parts on the oxygen generator, including air compressor, air tank, oxygen generator, booster (oxygen booster pump) , oxygen tank, and integrated supply bus. When air compressor, oxygen generator, booster (oxygen booster pump) are under operation, the corresponding icons should show a high brightness color; when they are shutdown, the corresponding icons should show a low brightness gray color, as shown in Fig. 3.

January 6, 2014 10:21:56 Unit monitoring - Automatic mode Monday

Oxygen tank

Oxygen manifold

Oxygen concentration

Start/stop pressure

Air Oxygen Air tank compr concentra Stop the device: 8.5 kgf tor essor Booster Start the device 5.5 kgf

Return Stop Start Inquiry

Oxygen tank pressure

Fig. 3 - Unit monitoring interface ► If clicking the icons of “Parameter settings” and “Maintenance and commissioning”, the password input box will be popped up, in which the correct password is entered and then the corresponding operation interfaces can be logged into. The two interfaces are used by the manufacturer’s technical personnel for device maintenance and debugging as required, and the users do not need to learn their specific use methods. ► If clicking “Alarm query” icon, the screen enters the alarm query interface of the oxygen generator, as shown in Fig. 4.

January 6, 2014 10:23:32 Alarm query Monday

The emergency stop button is pressed! Prompt: Red The undervoltage time of the compressed air is > 3min! letters indicate an The pressure of the compressed air had a big change! item failure! The air compressor fails! Fault reset The booster pump fails! The intake pressure on the booster pump is too low! The intake pressure on the booster pump is Return too high! monitor The pressure sensor on the oxygen tank fails! The pressure in the oxygen tank is too high! The pressure in the oxygen tank is too low! Return The oxygen concentration is too low! The oxygen concentration sensor fails!

Copyright: Jiangsu Yuwell Medical Device Co., Ltd. 15 Operation instructions

Fig. 4 - System alarm interface When the system fails, the device will send a sound and light alarm and there will be an obvious alarm prompt on the touch screen; if clicking the query button on the touch screen, you can find the detailed alarm information. If pressing the reset button on the control panel, you can clear the fault alarms that have occurred, but can not clear the fault alarm that is occurring. There are 12 alarm indications on the alarm interface, to prompt the problems during the oxygen concentration, including that the emergency stop button is pressed, the undervoltage time of the compressed air is > 3min, the air pressure has a big fluctuation, the air compressor fails, the booster fails, the pressure at the booster pump intake port is too low, the pressure at the booster pump intake port is too high, the pressure sensor on the oxygen tank is abnormal, the pressure in the oxygen tank is too high, the pressure in the oxygen tank is too low, the oxygen concentration is too low and the oxygen concentration sensor is abnormal. Under normal circumstances, all letters are displayed in green, which indicates that the appropriate system indicators are normal. When the system fails, the letters corresponding fault will be displayed in red, and the maintenance personnel can perform the repair according to the alarm fault prompt. After the fault is solved and the device is re-started, the system can be operated normally to concentrate the oxygen.

Note: If each icon displayed on the touch screen is different with the actual display, the actual display should be preferred!

16 Operation instructions

4.10 PLC cabinet layout schematic

PLC cabinet layout schematic of oxygen generator

17 5. Comprehensive maintenance guide

5. Comprehensive maintenance guide

5.1 Maintenance notices ► Do not attempt to modify or enhance the performances of the oxygen generator in any way; ► In order to ensure the product service life and the use conditions, the product and its components should be maintained carefully according to the requirements of the prescribed service intervals, especially when the device is operated in harsh environmental conditions; ►The device should be maintained by the qualified or trained personnel, other than non-qualified or non-trained personnel, in order to avoid any device damage or personal injury; ► During the maintenance and repair period, the device must be shut down and the power supply must be turned off, the air pressure in the pipeline and the device must be relieved, in order to ensure that the device is powered off under zero pressure during maintenance and repair period; ► The device maintenance or repair should be recorded properly; ► Regularly check the grounding condition for the device; any problem, such as corrosion or broken of the grounding line should be solved timely; ► During the whole process from the device delivery to scrap, the routine maintenance should be performed by the trained and qualified personnel designated by the manufacturer; ► The regular maintenance of the large overall device and major parts and the replacement of spare parts and consumables should be serviced by manufacturer; ► A list of some parts and consumables required for replacement in the product service life is implied in “Regular maintenance items and schedule” in Chapter 5.5, which is a list of parts and consumables generally required for maintenance and replacement; there may be other parts or consumables required for replacement, which can not be listed in the manual; for any problem, please consult the manufacturer; ► Without a prior notice, the manufacturer has the right to change or adjust the information about maintenance items, the list of parts and consumables and etc.; ► The wastes and residues should be disposed according to the relevant national laws and provisions.

※ Special notes ► The adsorption capacity and service life of the molecular sieve can be impacted by temperature, humidity and environment, that means, the molecular sieve has a strong oil and water absorption ability; if the molecular sieve has adsorbed the oil and water, its adsorption capacity will be greatly decreased, resulting in the decline of the oxygen output concentration and production, and abnormal oxygen supply, which can meet the requirements for the intended use of the oxygen generator. ► Any improper operation in the device maintenance, cleaning, and repair processes may affect on the adsorption capacity and service life of the molecular sieve, even the molecular sieve should be replaced in advance in order to ensure the normal use of the device.

18 Comprehensive maintenance guide

5.2 Operation and maintenance prompts ► During the normal operation of the device, it does not require any additional adjustment and operations. The operator is only required to monitor the operation parameters and check the device operation. ► During the normal operation of the device, the operator on duty is only required to perform the following works:

Check item Check method Check frequency

Actual load pressure, temperature parameter and associated prompt on Visual inspection 1time/4h the air compressor integrated with cooling and drying functions

Automatic drain conditions for the drain device on the cooling and Visual inspection 1time/4h drying machine

Sewage drain situation of the float ball sewage valve on the precision Visual inspection 1time/4h filter

opened manually and closed Manual drain valve on the precision filter 1time/4h with 3s

Pressure gauge indicators on the air tank, absorption tower in the oxygen Visual inspection 1time/4h generator and the pressure relief valve

Pressure gauge indicators on the booster (oxygen booster pump) and the Visual inspection 1time/4h oxygen tank

5.3 Routine maintenance 1. Routine maintenance contents:

Frequency (times) Item Before the Mont Quarter Requirements Daily weekly first start hly ly Clean the air 1 time Clean, no blockage intake filter Check the belt The belt should be tensioned, 1 time 2 times tension no loose Air Check the cooling 1 time 1 time Within the normal range compressor oil level integrated Control cabinet: The joints should be reliable, with cooling Check all electrical 1 time 1 time no loose and drying joints functions Check the condensation and 6 draining from the Works properly, no leakage times cooling and drying machine Precision Check the sewage 6 Smooth, non-clogging filter pipes times

19 Comprehensive maintenance guide

Check the exhaust Muffle box 1 time Smooth, non-clogging port Clean any Device 1 time Dry and clean dust/oil/water

2. Filter screen cleaning methods: ► Blow the filter screen with an air gun with a low pressure air from the reverse direction, to remove the dust; the compressed air to be used should be clean, dry and free of grease; ► If the dust can not be completely removed, the filter surface should be wiped lightly with a soft brush to remove the dust adhesion; ► It also be placed on the warm water at 35- 40℃ added with an appropriate amount of neutral detergent for washing, and rinsed with the clean water, and then installed into the air compressor until it is completely dried. 3. Device cleaning methods: ► The device can be wiped with a cloth with slight moisture; ► The device can not be cleaned with any corrosive or hot cleaning fluid; ► The device can not be wiped with a too wet cloth, to avoid any water droplet to enter into the interior of the device.

5.4 Regular maintenance ► The regular maintenances and repairs in the warranty scope should be performed by the manufacturer, and others should be performed by the trained and approved personnel designated by the user. ► For the list of regular maintenance items, please see “Regular maintenance items and schedule”. ► For the details about the operation, maintenance and troubleshooting on the air compressor integrated with cooling and drying functions in the oxygen generator, please see “7G-5A medical molecular sieve oxygen generator user manual attaching document”. ► For any problem that is unable to resolve, or not detailed in the both manuals, please contact the manufacturer, and the related personnel from our company will help you to solve the problem.

20 Comprehensive maintenance guide

5.5 Regular maintenance items and schedule

Maintenance items Functional check Quantity Maintenance No. Maintenance after the first Name of spare part/wear part /unit cycle measures operation Cleaning or Air filter 1 unit 3,000 h/time replacement Oil-gas separation filter Replacement 1 unit 6,000 h/time cartridge Oil filter cartridge Replacement 1 unit 3,000 h/time Air compressor cooling Replacement 6,000 h/time oil Checked by Valve KAESER 1 group 12,000h/time engineer Function All electrical joints 1 year/time test/fastening Air compressor Functional integrated with Safety relief valve 1 unit 1 year/time 1 check cooling and Visual drying functions Cooling oil level 1 week/time inspection Visually Drive belt check/adjust 500 h/time ment 12,000h/times (at Air compressor motor Replacement 1 unit least 1 time/3 bearing years) Check and Each 1 Oil cooler and air cooler clean the 1,000 h/time unit filter pad Cleaning or Electronic draining device 1 unit 3,000 h/time replacement Precision filter cartridge Replacement 1 unit 6,000 h/time (AO level) (depending on the Precision filter cartridge Replacement 1 unit use environment; (AA level) Filter (UK if necessary, the 2 Precision filter cartridge Dominique) Replacement 1 unit replacement cycle (ACS level) should be Precision filter (AAR Replacement 1 unit shortened) level) Precision filter (AA level) Replacement 1 unit 6,000 h/time Oxygen 3 Oxygen analyzer Calibration 4,000 h/time analyzer 4 Flowmeter Calibration 1 unit 8,000 h/time

21 Comprehensive maintenance guide

Pressure indicator on air Functional 1 unit 2,000 h/time tank check Pressure indicator on Functional 1 unit 2,000 h/time adsorption tower A check Pressure indicator on Functional 5 Pressure gauge 1 unit 2,000 h/time adsorption tower B check Pressure indicator on Functional 1 unit 2,000 h/time oxygen buffer tank check Pressure indicator on Functional 1 unit 2,000 h/time oxygen tank check Pressure transmission (-1 Functional 1 unit 2,000 h/time Pressure ~ 10bar) check 6 transmission Pressure transmission (0 ~ Functional 2,000 h/time 10bar) check

Maintenance items Functional Maintenance check after No. Maintenance Quantity Name of spare part/wear part cycle the first measures operation Pressure relief Pressure relief Functional 7 valve at oxygen 2 units 2,000 h/time valve check buffer tank outlet Tightness / Safety valve on air 8 Safety valve functional Each 1 unit 2,000 h/time tank / oxygen tank check Float ball auto drain 1 unit 2,000 h/time valve Sewage drain ball Tightness / Sewage drain 1 unit 2,000 h/time 9 valve on air tank functional valve Sewage drain ball check valve on oxygen 1 unit 2,000 h/time tank Tightness / Tightness of 10 functional 4,000 h/time pipeline/valve check Wiring terminal 4,000 h/time Check the Power supply Oxygen function for 11 wiring and 4,000 h/time generator any wiring grounding line loosening Grounding line 4,000 h/time

22 Comprehensive maintenance guide

Check the function for any wiring Hose 2,000 h/time loosening, or clogging Whether there Sewage drain is clogging or 2,000 h/time pipeline not smooth Whether there Exhaust muffle box is clogging or 2,000 h/time not smooth 1st piston ring 2 / unit 2,000 h/time 2nd piston ring 2 / unit 2,000 h/time 1st guide ring 2 / unit 2,000 h/time 2nd guide ring 2 / unit 2,000 h/time Perform the 12 Booster 1st suction valve functional 1 / unit 2,000 h/time bump sheet check; if (VWD0.08/1 2nd suction valve necessary, 1 / unit 2,000 h/time 0, 2 units) sheet replace it Exhaust valve sheet 8 / unit 2,000 h/time Cylinder head pad 2 / unit 2,000 h/time Valve gasket 2 / unit 2,000 h/time Safety valve 1 / unit 2,000 h/time Perform the Single-stage functional 13 oxygen relief check; if 1 / unit 4,000 h/time valve necessary, replace it

Note: The regular inspection cycles and the replacement cycles for parts and wear parts indicated in this manual are the replacement cycles under normal use conditions. “-” indicates no or uncertainty, and “√” indicates that the part must be replaced.

23 Comprehensive maintenance guide

5.6 Accessories For any problem about the oxygen generator provided by our company to users, you can contact us. For air compressor integrated with cooling and drying functions, booster (oxygen booster pump) and other accessories not manufactured by our company, their parts or wearing parts can be purchased directly from the our company’s after-sales service department, and replaced under the guide of the professionals recognized by the manufacturer. Our company will not be responsible for the consequences due to the user’s own purchase, illegal operations and other actions.

24 6. Fault diagnosis and troubleshooting

6. Fault diagnosis and troubleshooting

6.1 Causes and solutions of common faults

Fault symptoms Possible causes Treatment measures

Open the manual ball valve under the air tank, The compressor outlet pressure is too high and relief the air pressure in the pipeline

The touch screen is not reset Press “Reset” button on the touch screen

See the alarm display; any alarm message Device failures and an alarm is sent should be handled by professionals

Pressure transmitter (or pressure sensor) failure Replace the new pressure transmitter

The environment temperature is below 5℃ or Install the air-conditioning to maintain the above 40℃ environmental temperature between 5℃ - 40℃ The system start fails 1. Switch to the integrated supply bus for oxygen supply and wait for the power supply recovery

The power supply is not normal or abnormal trip 2. Check the proper fuse installation and make sure that it is not fused

3. Check the input power for any abnormity, if necessary, troubleshoot it.

After a power outage or abnormal shutdown, the Press the reset button on the air compressor compressor does not reset

1. Clean the air compressor intake filter screen, clean or replace the air filter The operation pressure on the adsorption tower is decreased and the oxygen production is decreased 2. Replace the precision filter cartridge

3. Check the pipe for leaks

1. Open the reserve integrated supply bus The oxygen consumption is excessive 2. Start both oxygen generators The oxygen generator can not stop Pressure transmitter (or pressure sensor) failure Replace the new transmitter

The controller wiring is loose Fasten the controller wiring terminal

Close the oxygen booster pump outlet, check the The oxygen booster pump can not be pressurized boosting speed and the maximum pressure (if equipped) value, or start the other oxygen booster pump

See the alarm display; any alarm message Device failures and an alarm is sent should be handled by professionals

25 Fault diagnosis and troubleshooting

Fault symptoms Possible causes Treatment measures

The alarm indicator is The operator should take immediate measures lit, and the alarm horn The oxygen generator fails for troubleshooting, and notify to the beeps manufacturer if necessary

Check the oxygen pipeline for leaks Check the pipeline The oxygen analyzer Re-calibrate it in accordance with the indication is improper The oxygen analyzer should be re-calibrated requirements

1. Clean the air compressor intake filter screen, The air supply volume from the air source is clean or replace the air filter decreased 2. Replace the precision filter cartridge

Adjust the manual flow control valve to a The oxygen outlet flow is too large predetermined flow value The oxygen Check the pipeline with soapy water, tighten concentration is too low Leaks of the intake or exhaust pipeline bolts on the flange or replace the gasket

The sewage drain valve leaks Stop the device and replace the valve

Observe the displayed corresponding pressure The opening positions of the intake valve and the value and concentration value to correct the exhaust valve are changed opening position of the manual valve

26 Fault diagnosis and troubleshooting

Fault symptoms Possible causes Treatment measures

The operation pressure for the control valve it too low, or the opening and Check the control valve and it pipeline closing speeds for various valves are inconsistent

The switching valve or solenoid valve Check the switching valve or solenoid fails valve

The oxygen concentration is decreased The compressor fails Contact the manufacturer suddenly PLC fails Contact the manufacturer

Sewage drain valve leak Stop the device and replace the valve

Observe the displayed corresponding The opening positions of the intake pressure value and concentration value valve and the exhaust valve are changed to correct the opening position of the manual valve

Check the pipeline for a good seal and The pipelines leaks the flange bolts for fastening, or replace the seal gasket

The switching valve is not sealed, with a Stop the device and replace the valve serious leak

Check the pipeline with soapy water, Leaks of the intake or exhaust pipeline tighten bolts on the flange or replace the gasket

Sewage drain valve leak Stop the device and replace the valve

Observe the displayed corresponding The oxygen concentration drops slowly The opening positions of the intake pressure value and concentration value valve and the exhaust valve are changed to correct the opening position of the manual valve

The molecular sieve is exposed to the atmosphere long-time, leading to Stop the device and replace the excessive water absorption and molecular sieve decreased oxygen concentration and production

27 Fault diagnosis and troubleshooting

6.2 Emergency troubleshooting ► If operator finds a device failure, the following measures should be taken immediately: ■ Press the stop switch on the control cabinet (the device is under the shutdown status); ■ Turn off the power switch on the air compressor integrated with cooling and drying functions; ■ Turn off the power supply on the cabinet and the device enters into the shutdown status; ■ Switch to the backup oxygen generator or integrated supply bus for oxygen supply.

1. When the device is abnormal or fails, the oxygen generator will send a sound and visual Note: alarm, to prompt the operator for an immediate troubleshooting. 2. Troubleshooting method: The trained professional should perform the troubleshooting in accordance with the requirements specified by the manufacturer. 3. After the device stops, it should be re-started manually as necessary.

6.3 Power-off alarm 1. When the power supply is suddenly interrupted, the power alarm will sound; after the power supply is restored, the alarm will automatically shutdown. 2. The power shutdown alarm is embedded with a power storage capacitor and an automatic charging circuit, the charging time is longer than 10min, and the alarm time is longer than 120min. When the alarm sounds, press “Reset” button to temporarily turn off the alarm.

6.4 Emergency measures ► That the oxygen concentration can meet the requirement due to the device failure, can be handled in the following procedures: A. Check whether the oxygen production exceeds the standard production; if exceeded, adjust the flow control valve in the oxygen output pipeline to the standard oxygen production requirements; B. Re-calibrate or correct the oxygen analyzer; C. Switch to the integrated oxygen supply bus; D. After the device resumes to the normal operation, switch from the integrated oxygen supply bus to the original operation mode.

(1) The oxygen concentration in the air should be calibrated as 20.9%, and it can be Note: calibrated accurately with the standard oxygen concentration of 99.5%; (2) Due to the impacts from the environment temperature, the air pressure and relative humidity, a decline in the oxygen concentration can be caused by any deviation from the operation conditions, which is a normal phenomenon.

28 Fault diagnosis and troubleshooting

6.5 Precautions ► Once the device fails and an alarm is sent, immediately stop the device, and then analyze the cause and take appropriate measures; ► After troubleshooting and before re-start, must check the pressure in the tank and the wiring connection in accordance with the foregoing requirements, and then start and operate the device with the start procedures;

Note: At this point, it belongs to a manual start and shutdown after an exception, please press “Reset” button on the touch screen to restore the procedure; If the fault cause can not be determined or the fault can not be solved, please contact the manufacturer in the first time; ► In the period for waiting manufacturer’s technical support personnel, please start the backup oxygen generator or use the integrated supply bus for oxygen supply, so as to avoid other unpredictable consequences due to any abnormal oxygen output! ►During troubleshooting, must observe the following notes: A. To operate the original powered device, first check whether the power supply has been turned off; if necessary, pull down the main switch or disconnect the connection line; B. After the power supply is turned off, please wait for 5min or more, so as not to damage due to the electricity on the device; C. The high-speed rotating parts must completely stop before the cover is opened for any operation; D. The high-temperature parts must be cooled fully to a safe temperature before access for any operation. ► Unless otherwise specified in the user manual or other related documents, in the maintenance and repair, the removed parts should be installed substantially in the reverse order for removal.

Note: It should be avoided that some small parts are installed in the wrong positions, such as bolts, washers, line clamps; In maintenance and repair, the recommended measuring instruments or equivalent should be used.

Warnings: Do not start the device in the following situations:

1. The parts on the device are not installed securely; 2. Whether the removed parts are installed securely in place and the wirings are connected properly are not confirmed; 3. The device cover (for the air compressor integrated with cooling and drying functions, etc.) is not installed securely; 4. Another person is operating the device; 5. Other illegal operations have been performed.

29 7. Other notes

7. Other notes

► The device life is 10 years. When the device is used normally, it should be fully checked and maintained at least twice a year; it the inspection results can meet the requirements, the device can be used continuously; ► The scrapped device should be disposed according to the relevant regulations and requirements from the local environmental protection department; ► When the device is under operation, the local temperature may be increased, so the burns should be avoided during operation, maintenance and repair for the device; ► Please regularly check the intake and exhaust ports for unblocking, the drain valves and pipeline for unblocking, and the grounding line for reliably and securely; ► Please equip the appropriate fire-fighting devices in the machine room according to the relevant fire regulations and requirements,; ► Define the operator rights, to ensure that the operations for violation of safety procedures can not be performed; ► Please store properly the keys to related devices provided by our company, to avoid to be obtained by non-essential personnel; ► For special storage and use conditions for any device, please contact our company before buy it, and our staff will design the special product according to the actual situations. Please do not purchase any other device and perform any improper operation; ► Please attach properly all kinds of warning signs in the device room; ►Please properly store the documents provided by our company in the proper place, for easy reference at any time; ► Please keep purchase invoice, warranty card, contract, and other documents, for use during the maintenance and repair services; ► For any unusual problem, please contact the manufacturer.

Note: The remote control part is optional; for the details, see the remote control manual.

30 8. After-sales services

8. After-sales services

►The device, option items, etc. provided by our company shall be maintained and repaired regularly by the manufacturer. ► The free warranty services should be provided within the warranty period specified the contract or the written agreement signed with the user, and the paid services can be provided by the manufacturer beyond the warranty period. ► Any damage due to normal wear and tear, overload and error operations is not covered in the factory warranty scope, and all details should be performed according to the requirements in the contract or the written agreement signed between the manufacturer and the user. ► Our company is only responsible for warranty of the products on the oxygen concentration system provided by the manufacturer, and is not liable for compensation for other losses due to damage of the oxygen generator. ► For damages in the following cases, our company does not provide any warranty and is not responsible for the consequences. A. Vandalism; B. Operation error; C. Third-party error; D. Damages due to the use of parts or consumables provided by non-manufacturer; E. Force majeure or other unforeseen reasons; F. Beyond the warranty scope specified in the contract.

Note: After the device is delivered, the manufacturer should perform relevant trainings for the operators specified by the user, and maintenance and repair methods for the medical molecular sieve oxygen generator are one part of the training contents.

※ Special notes: If you choose one product from our company, our company will provide a “Contact organization map” to you; if you need to contact out company, you can contact the relevant personnel via the above contact method at any time, we will be happy to service you!

31 9. List of annexes

9. List of annexes

Device annexes are the parts or documents attached on the oxygen generator such as spare parts, manual, warranty card, etc., as follows:

Instructions Each 1 copy (user manual, materials attached on the user manual, contact organization map)

User design documents 1 copy (device layout plan, piping layout, etc.)

Factory test report 1 set

Warranty card (including the certificate) 1 set

Device operation record sheet 1 set of (sample sheet)

Device maintenance/repair record sheet 1 set of (sample sheet)

User satisfaction questionnaire 1 copy (filled by users)

Other documents provided by the company

Other documents and annexes agreed in the contract

※ For more details, please refer to “Device Packing List”.

32

Production license number: (Suzhou Food and Drug Administration Apparatus production license number) SFDAA 0089-2001 Registration No: Suzhou Food and Drug Administration Apparatus (Approved) No. 2540697-2013 Product standard No.: YZB/Su 0380-2009

National free service hotline: 400-8287768 800-8286633 http://www.yuwell.com Stock code: 002223 Jiangsu Yuwell Medical Device Co., Ltd. (Publisher) Registration (Production) Address: Yunyang Industrial Park, Danyang City Tel: 0511-86900833 Fax: 0511-86900878 Shanghai Yuwell Medical Device Co., Ltd. (Distribution) Address: 8th Floor, Sichuan North Road 2261~2263#, Shanghai City Tel: 021-65757288 Fax: 021-65757988 Paper