Professional Series Parents’ Guide

Warranty Respironics warrants that the monitor will be free from defects in materials and workmanship for a period of two years from the time of purchase. Respironics accessories are warranted free of defects in materials and workmanship for a period of 90 days from the time of purchase. The Respironics equipment and authorized accessories are designed to function as described in the operator’s manual. The user/owner of this equipment shall have sole responsibility and liability for any injury to persons or damage to property (including this equipment) resulting from: Operation not in accordance with supplied operating instructions; Maintenance not in accordance with authorized maintenance/operational instructions; Service by anyone other than a factory authorized service representative; Modification of the equipment or accessories; or Use of damaged or unauthorized components and accessories. THIS LIMITED WARRANTY IS IN LIEU OF ANY AND ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE; TO THE EXTENT THAT STATE OR FEDERAL LAW PROHIBITS EXCLUSIONS OF IMPLIED WARRANTIES, ANY SUCH IMPLIED WARRANTY IMPOSED BY LAW SHALL BE LIMITED TO A PERIOD OF NINETY (90) DAYS FROM THE DATE OF THE INITIAL PURCHASE FROM RESPIRONICS.

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User/Owner Responsibility The Respironics monitor and accessories are designed to work as described in the operator’s manual. The user(s) of this equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. The monitor and its accessories should not be modified. The following list incorporates the owner’s responsibilities: Periodic check and maintenance of equipment; Replacement of components as required for safe and reliable operation; Replacement of ineffective parts with parts supplied by Respironics, Inc.; Equipment that is not functioning properly must not be used until all necessary maintenance has been completed and a factory-authorized service representative has certified the equipment as ready for use; The monitor and any of its accessories should not be modified; As a general rule, the proper performance of the monitor should be verified with a Respironics Model 5000 Simulator according to the Checkout Procedure Manual between each patient use and/or every six to 12 months, whichever is more frequent. Please contact your homecare provider for details. The user of this equipment is responsible for reading, understanding, and following the Warning and Caution statements throughout this manual.

Table of Contents Introduction ...... 1 About this Manual ...... 1 Indications for Use ...... 1 What Is the Purpose of the SmartMonitor 2 PS?...... 1 Warnings and Cautions...... 3 Warnings ...... 3 Cautions ...... 10 How Does the SmartMonitor 2 PS Work?...... 13 How the Alarms Operate...... 14 FCC Part 68 Telecom Information...... 22 Registration Number and REN ...... 22 USOC Jack...... 22 Compliant Accessories...... 22 Number of RENs ...... 22 Caution...... 23 Changes in Service...... 23 Problems ...... 24 Repairs...... 24 Party Lines ...... 24

Caution...... 24 Industry Canada Requirements...... 25 IC Abbreviation...... 25 REN...... 25 Industry Canada CS-03 Notice...... 26 FCC Part 15 ...... 27 Getting to Know the Monitor...... 29 SmartMonitor 2 PS Features...... 31 Top Panel Features...... 31 Front Panel Features ...... 33 Side Panel Features...... 37 Back Panel Features...... 38 Setting Up the SmartMonitor 2 PS for Respiration, Heart, and SpO2 Monitoring...... 40 Responding to Alarms...... 56 Patient Alarms...... 56 Testing the Alarm ...... 56 If an Alarm Sounds: Patient Alarms ...... 58 System Alarms ...... 66 Reducing False Alarms ...... 73

Monitoring Your Baby...... 75 Turning on the SmartMonitor 2 PS...... 75 Turning off the Monitor - Sibling Alarm...... 76 Monitoring Your Baby's Breathing ...... 78 Respiration Light/Display ...... 78 Apnea Light ...... 79 Monitoring Your Baby's Heart Activity ...... 81 Heart Rate Light/Display ...... 81 High Heart Rate Alarm Light ...... 82 Low Heart Rate Alarm Light...... 83 Monitoring Your Baby’s Oxygen Saturation Level ...... 84 SpO2 Light/Display ...... 85 High SpO2 Alarm Light ...... 86 Low SpO2 Alarm Light...... 87 Portable Operation of the SmartMonitor 2 PS...... 89 Charging the SmartMonitor 2 PS ...... 89 Transferring SmartMonitor 2 PS Information ...... 91 Modem Download ...... 91 Modem Auto Dial...... 93 Modem Auto Answer in Communications Mode...... 95 Modem Auto Answer in Monitor Mode...... 97

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Transferring SmartMonitor 2 PS Data to a Memory Card...... 99 Caring for Your SmartMonitor 2 PS...... 103 Cleaning Instructions...... 103 Performing a Functional Self-Test ...... 105 Self-Test Troubleshooting...... 109 Troubleshooting...... 112 Glossary ...... 128 SmartMonitor 2 PS Clinical Summary...... 130 Index ...... 132

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Introduction About this Manual This manual provides all the information you need to set up and operate the Respironics SmartMonitor 2 PS and explains how to use it to monitor your baby. Carefully read and understand this manual before using the system. Words that appear in Bold Italics are defined in the Glossary in the back of this manual.

Indications for Use The SmartMonitor 2 PS is intended for use in continuous monitoring of respiration, heart rate and SpO2 levels of infant patients in home or hospital environments. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.

What Is the Purpose of the SmartMonitor 2 PS? The SmartMonitor 2 PS is an apnea monitor designed to monitor and record your baby's breathing (respiration) heart (cardiac) activity and SpO2 levels (functional oxygen saturation). The monitor alerts you if any of these activities exceeds the limits prescribed by your physician. Patient alarm limits are set by your homecare provider before you receive your SmartMonitor 2 PS monitor. During your baby’s monitoring, when your baby's breathing

1 Introduction

effort, heart activity and SpO2 levels are not within these set boundaries, an indicator light comes on and an alarm sounds. This manual explains how to set up the SmartMonitor 2 PS, how to monitor your baby, and how to transfer the information. Other auxiliary devices may also be used with the SmartMonitor 2 PS: Respironics 930 Masimo Radical Ohmeda OXI Oximeter Oximeter Pulse Oximeter Nellcor N-200 Pulse Nellcor NPB-295 Synectics pH Oximeter Pulse Oximeter Meter Nova Cosmo Nova Cosmo Sandhill pH Meter Oximeter ETC02

If your physician prescribes any of these devices, your homecare provider can discuss them with you.

2 Warnings and Cautions

Warnings and Cautions Please read this section carefully before using the SmartMonitor 2 PS.

Warnings

Caution! U.S. federal law restricts this device to sale by or on the order of a licensed physician.

A warning indicates the possibility for injury to the user or operator. 1. Before using the SmartMonitor 2 PS, charge the internal battery pack. Connect the power supply to the device, and ensure that it is plugged into a functional AC wall outlet for a minimum of six hours. 2. The SmartMonitor 2 PS will not operate without the internal battery pack. Contact your homecare provider if the device does not operate properly. 3. Place the SmartMonitor 2 PS on a secure and level surface to prevent the device from falling. Do not place the monitor on the floor or in any location where the device could become a tripping hazard. Do not place the monitor in a crib, ensuring that the baby cannot roll onto the device’s hard surface. 4. If an emergency occurs and access to the telephone is required while the SmartMonitor 2 PS is connected to the telephone wall jack, unplug the phone cord from the wall jack and connect a working telephone to the jack.

3 Warnings and Cautions

5. Do not use the SmartMonitor 2 PS in the presence of flammable substances such as anesthetics or cleaning agents. 6. Do not defibrillate a patient who is attached to the SmartMonitor 2 PS. 7. Do not use skin creams, electrode gels, oils or lotions under the sensors. 8. SmartMonitor 2 PS may not be able to detect all episodes of inadequate breathing. If a baby has apnea due to choking (obstructive apnea), the monitor could mistake movement caused by choking for breathing. 9. SmartMonitor 2 PS is a monitoring device only. It does not prevent the loss of breathing or heart activity, nor will it restore breathing or heart activity. It will not prevent death. 10. Anyone using the SmartMonitor 2 PS to monitor an infant should be trained in current infant Cardiopulmonary Resuscitation (CPR), which is a proper way to restore breathing and heart activity. 11. The SmartMonitor 2 PS is not intended for use with cardiac or diaphragmatic pacemaker patients. 12. When using the monitor near patients on oxygen, the monitor must be kept at least three (3) feet away from the oxygen tank (source) or other flammable gases to prevent a fire hazard. 13. Do not place the monitor or external power supply in any position that might cause it to fall on the baby. Do not lift the monitor by the power supply cord or patient cable; use only the handle on the monitor. 14. Use only those accessories provided by your homecare provider with this monitor.

4 Warnings and Cautions

15. Do not allow the patient cables, lead wires or power supply cable to become tangled, coiled, crossed, or wrapped around the baby’s neck, arms, or legs. This could result in strangulation. 16. Do not connect to an electrical outlet controlled by a wall switch or dimmer to prevent inadvertently turning the power to the monitor off. 17. Do not block the speaker or place items in front of the speaker located on the front of the device. This could prevent the monitor alarm from being heard. 18. Never use the monitor on your baby while your baby is being bathed. This could result in electrical shock and/or damage to the equipment. 19. Disconnect the power supply and phone line during lightning storms to reduce risk of electrical shock to the baby. The SmartMonitor 2 PS will not download by modem when the power supply and phone line are disconnected. 20. Never use an extension cord with the power supply as this may cause a fire and/or tripping hazard. 21. Be aware of signal interference that can occur from external sources. Electronic signals are required for the SmartMonitor 2 PS to function. Sources of external interference could cause the monitor to miss apnea and heart rate alarms. Even though the monitor contains methods and techniques which can provide protection from external sources of interference, you should operate the monitor as follows: • Keep monitoring equipment, patient, and patient leads at least three (3) feet away from all electrical appliances. Some examples of this include TV sets, electric blankets, air conditioners, microwave ovens, cordless telephones, cellular phones, waterbeds, and home computers.

5 Warnings and Cautions

• Synthetic fabric from draperies or rugs can also cause interference due to static electricity. Touching a conductive material with a grounded path, such as a wall or crib, before handling the patient or the SmartMonitor 2 PS often prevents static build-up problems. • Strong transmitter signals from TV, radio, airport, police, fire, and ambulance stations could be picked up as heart and/or breath signals. If located less than one (1) mile from one or more of these sources, the monitor may be affected. 22. Do not touch the monitor and the baby simultaneously. 23. In some locations, the monitor will not work properly. If the monitor is affected by external interference in the area, you may not be able to use the monitor. Contact your homecare provider for further assistance. NOTE: Use of the third (green – RL) electrode and lead wire is normally not required but may help reduce excessive false low heart rate alarms. 24. If monitoring two or more infants in the same area, keep the monitors, patient, patient cables, and lead wires at least three (3) feet apart. Having the patient cables and lead wires close together may cause missed apneas due to interference. 25. Do not connect the baby to the SmartMonitor 2 PS if the monitor is placed in the Communications Mode. The apnea and heart alarms do not work when the SmartMonitor 2 PS is in this mode. 26. Do not use the SmartMonitor 2 PS at the same time as other impedance monitors. This may cause missed apneas due to interference.

6 Warnings and Cautions

27. If you notice any unexplained changes in the performance of the device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, or if the enclosure is broken, discontinue use. Contact your homecare provider. 28. Inspect the power cords and cables often for any signs of damage. Replace a damaged cord or cable immediately. 29. Do not use non-safety style lead wires and patient cable configurations with this monitor. Their use may pose a risk of severe electrical shock or death. Refer to the instructions in this manual to ensure proper connections. Use only Respironics recommended safety lead wires, patient cables, electrodes and sensors. 30. Pins of connectors identified with the ESD warning symbol should not be touched. Connections should not be made to these connectors unless ESD precautionary procedures are used. Precautionary procedures include methods to prevent build-up of electrostatic discharge (e.g., air conditioning, humidification, conductive floor coverings, and non-synthetic clothing), discharging one’s body to the frame of the equipment or system or to earth or a large metal object, and bonding oneself by means of a wrist strap to the equipment or system or to earth. 31. Explosion hazard. Do not use the monitor in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. 32. If an alarm condition occurs while the alarm silence period is active, the only alarm indications will be visual displays and symbols related to the alarm condition.

7 Warnings and Cautions

33. The monitor is to be operated by qualified personnel only. This manual, accessory directions for use, all precautionary information, and specifications should be read before use. 34. Do not use damaged patient cables. Do not immerse the patient cables in water, solvents, or cleaning solutions. (The patient cable connectors are not waterproof.) Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the directions for use for reusable patient cables.

35. The SpO2 sensor site must be changed every four (4) hours. Note: Exercise extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently moved. Assess the site at least every two (2) hours with poorly perfused patients.

36. If the SpO2 sensor is damaged in any way, discontinue use immediately.

37. To prevent damage, do not soak or immerse the SpO2 sensor in any liquid solution. Do not attempt to sterilize.

38. Intravascular dyes may lead to inaccurate SpO2 measurements. 39. Elevated levels of Carboxyhemoglobin (COHb) or Met hemoglobin (MetHb) may lead to inaccurate SpO2 measurements.

40. Failure to apply the SpO2 sensor properly may cause incorrect measurements.

41. Do not use the SmartMonitor 2 PS or the SpO2 sensor during MRI scanning.

42. Avoid placing the SpO2 sensor on any extremity with an arterial catheter or blood pressure cuff.

8 Warnings and Cautions

43. The conductive parts of electrodes and patient cables should not be in contact with other conductive parts including earth. 44. Do not use during high frequency surgical procedures. 45. The SmartMonitor 2 PS may only be used on one patient at a time. 46. Do not rock the baby or sleep in the same bed with the baby while monitoring. Touching or moving near the baby, monitor, or cables could cause the monitor to miss apneas. 47. Remove the electrode belt and the lead wires when the baby is not being monitored. Long-term wear may be uncomfortable.

9 Warnings and Cautions

Cautions

A caution indicates the possibility of damage to the device. 1. Perform the functional self-test if the SmartMonitor 2 PS has been x-rayed by an airport security check. 2. If your baby is breathing quietly and the respiration light flashes more or fewer times than your baby breathes, contact your homecare provider for service. 3. Do not send information via modem during electrical storms. Information could be lost or equipment could be damaged. 4. Handle the lead wires carefully to prevent them from breaking inside the insulation. Always grasp the lead wire at the strain relief area to remove them from the electrodes or patient cable. 5. Any foreign matter that gets into the enclosure of the SmartMonitor 2 PS may cause malfunction. 6. The use of accessories other than those specified, with the exception of cables sold by the manufacturer of the equipment or system as replacement parts or internal components could degrade signal quality and may result in increased emissions or decreased immunity of the equipment or system. 7. Do not place liquids on or near the SmartMonitor 2 PS. Liquids may damage the electronic components inside the monitor. Should liquid spill onto the monitor, shut the monitor off and contact your homecare provider.

10 Warnings and Cautions

8. Check the monitor’s respiration light. Listen while the baby breathes, and watch the respiration detection light on the monitor. While the baby is breathing quietly, the light should flash once and only once for each breath the baby takes. However the light may flash additional times when the baby is moving. If the baby is breathing quietly and the respiration light flashes more or fewer times than your baby breathes, stop using the device and contact your homecare provider.

How Does the SmartMonitor 2 PS Work?

How Does the SmartMonitor 2 PS Work? Your baby's breathing is measured by simply placing two electrodes on the sides of the baby's chest under his or her arms. As the baby's chest moves during breathing, the impedance between the electrodes will change. The SmartMonitor 2 PS detects these changes for determining the baby's breathing effort. If the SmartMonitor 2 PS does not detect these changes in breathing effort, a light will come on and an alarm will sound. SmartMonitor 2 PS also uses the electrodes on the chest to monitor heart activity by picking up the electrical changes produced by the heart. If the SmartMonitor 2 PS detects the heart rate outside the range ordered by the physician, a light will come on and an alarm will sound. The device also monitors blood oxygen levels (SpO2) through a sensor attached to the baby’s toe or finger. If the SmartMonitor 2 PS detects SpO2 values outside the range ordered by the physician, a light will come on and/or an alarm will sound.

13 How Does the SmartMonitor 2 PS Work?

How the Alarms Operate

Whenever your baby’s breathing effort, heart activity and SpO2 levels are not within the limits set by your physician, an indicator light will come on and an alarm will sound. The SmartMonitor 2 PS has two types of alarms: patient and system. Patient Alarms: A beeping alarm indicates one of the following patient alarm events:

• Apnea: Baby has stopped breathing for longer than the limit set by your physician. • Low Breath Rate: Breath rate is lower than the limit set by your physician. • Low Heart Rate: Heart Rate is lower than the limit set by your physician. • High Heart Rate: Heart Rate is higher than the limit set by your physician. • Low SpO2: SpO2 level is lower than the limit set by your physician. • High SpO2: SpO2 level is higher than the limit set by your physician.

System Alarms: A constant audible alarm indicates one of the following SmartMonitor 2 PS conditions: • Loose lead (for breathing and heart activity) • Loose Probe (for SpO2) • Low Battery (or Drained Battery) • Memory Full (or Memory Almost Full) • Accidental Power-Off • Internal System Error

14 How Does the SmartMonitor 2 PS Work?

Lights on the SmartMonitor 2 PS indicate which of these conditions exists. See the sections on Monitoring Your Baby, Responding to Patient Alarms and Responding to System Alarms for more information about alarms.

The SmartMonitor 2 PS may also alarm if there is an internal system error. If your monitor alarms and the lights are not illuminated, or if all of the lights are blinking on and off, look at the LCD display on the bottom of the device. If there is an internal error, a code will be displayed. Discontinue use of the monitor, and contact your homecare provider.

15 How Does the SmartMonitor 2 PS Work?

Symbols Table

Symbol Definition

Attention: Important information that should be read

Attention: Read accompanying documents

Type BF Applied Part (also shows Patient Cable Connector location)

RESET Button

POWER Off/On Button

16 How Does the SmartMonitor 2 PS Work?

Apnea Alarm Light

Respiration Light

Low Heart Rate Alarm Light

High Heart Rate Alarm Light

Low Battery Light

Memory Full Light

Loose Lead Light

17 How Does the SmartMonitor 2 PS Work?

Heart Rate Light

Power Light

Charger Light

Power Supply Connection

Input / Output Connection

18 How Does the SmartMonitor 2 PS Work?

Modem Port

Nurse Call Connection (for institutional use only)

SN Serial Number

Beats Per Minute

Breaths Per Minute

19 How Does the SmartMonitor 2 PS Work?

Oxygen Blood Saturation

Percent of SpO2

High SpO Alarm Light 2

ESD Warning Symbol

20 How Does the SmartMonitor 2 PS Work?

Power Supply Connector Position

IPX1 Drip Proof Equipment

Class II (Double Insulated)

21 How Does the SmartMonitor 2 PS Work?

FCC Part 68 Telecom Information Registration Number and REN This SmartMonitor 2 PS modem complies with Part 68 of the Federal Communication Commission (FCC) rules. On the bottom of the SmartMonitor 2 PS is a label that contains, among other information, the FCC registration number and the ringer equivalence number (REN) for the modem. If requested, this number must be provided to the telephone company.

USOC Jack The SmartMonitor 2 PS modem is designed to be used on standard device telephone lines. The suitable USOC jack (Universal Service Order Code connecting arrangement) for this modem is RJ11C or RJ11W (single line).

Compliant Accessories The telephone cord and modular plug provided with this equipment are compliant with applicable Federal Communication Commission (FCC) rules. This equipment is designed for connection to the premises wiring and telephone network using a compatible modular jack that is also compliant. See installation instructions for details.

Number of RENs The Ringer Equivalence Number (REN) is used to determine the number of devices that may be connected to a telephone line. Excessive RENs on a telephone line may result in the devices

22 How Does the SmartMonitor 2 PS Work?

not ringing in response to an incoming call. In most but not all areas, the sum of RENs should not exceed five (5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company.

Caution If this SmartMonitor2 PS modem causes harm to the telephone network, the telephone company will notify you in advance that temporary discontinuance of service may be required. But if advance notice is not practical, the telephone company will notify you as soon as possible. Also, you will be advised of your right to file a complaint with the Federal Communications Commission (FCC) if you believe it is necessary.

Changes in Service The telephone company may make changes in its facilities, equipment, operations, or procedures that could affect the operation of this equipment. If this happens, the telephone company will provide advance notice in order for you to make necessary modifications to maintain uninterrupted service.

23 How Does the SmartMonitor 2 PS Work?

Problems If trouble is experienced with this SmartMonitor2 PS modem, please contact your home care provider or Respironics at 1-800-345-6443 for repair or warranty information. If the equipment is causing harm to the telephone network, the telephone company may request that you disconnect the equipment until the problem is resolved.

Repairs No repairs are to be made by you. Whenever a technical problem occurs that you cannot handle, contact your homecare provider. Unauthorized repairs void registration and warranty.

Party Lines Connection to party line service is subject to state tariffs. Contact the state public utility commission, public service commission or corporation commission for information.

Caution If your home has specially wired alarm equipment connected to the telephone line, ensure the installation of the SmartMonitor 2 PS modem does not disable your alarm equipment. If you have questions about what will disable alarm equipment, consult your telephone company or a qualified installer.

24 How Does the SmartMonitor 2 PS Work?

Industry Canada Requirements

IC Abbreviation This equipment meets the applicable Industry Canada Terminal Equipment Technical Specifications. This is confirmed by the registration number. The abbreviation, IC, before the registration number signifies that registration was performed based on a Declaration of Conformity indicating that Industry Canada technical specifications were met. It does not imply that Industry Canada approved the equipment.

REN The Ringer Equivalence Number (REN) for this terminal equipment is 0.3B. The REN is an indication of the maximum number of devices allowed to be connected to a telephone interface. The termination on the interface may consist of any combination of devices subject only to the requirement that the sum of the RENs of all the devices does not exceed five.

25 How Does the SmartMonitor 2 PS Work?

Industry Canada CS-03 Notice

NOTICE: The Industry Canada (IC) label on the SmartMonitor 2 PS identifies certified equipment. This certification means that the equipment meets certain telecommunications network protective, operational and safety requirements as prescribed in the appropriate Terminal Equipment Technical requirements document (s). The Department does not guarantee the equipment will operate to the user’s satisfaction. Before installing the SmartMonitor 2 PS, users should ensure that it is permissible to be connected to the facilities of the local telecommunications company. The equipment must also be installed using an acceptable method of connection. The customer should be aware that compliance with the above conditions might not prevent degradation of service in some situations. The Respironics Service Center should coordinate repairs to certified equipment at 1-800-345- 6443. Any repairs or alterations made by the user to this equipment, or equipment malfunctions, may give the telecommunications company cause to request the user to disconnect the equipment. Users should ensure, for their own protection, that the electrical ground connections of the power utility, telephone lines, and internal metallic water pipe system, if present, are connected together. This precaution may be particularly important in rural areas.

Caution: Users should not attempt to make such connections themselves, but should contact the appropriate electric inspection authority, or electrician, as appropriate.

26 How Does the SmartMonitor 2 PS Work?

FCC Part 15

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Because this equipment generates, uses, and can radiate radio frequency energy, if it is not installed and used in accordance with the instructions, it may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. This can be determined by turning the equipment off and on. If this equipment does cause harmful interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Plug the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.

27 How Does the SmartMonitor 2 PS Work?

This device complies with Part 15 of the FCC rules. Operation of this device is subject to the following conditions:

(1) This device may not cause harmful interference, and (2) this device must accept any interference that may cause undesired operation.

Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Getting to Know the Monitor

When you receive the SmartMonitor 2 PS, make sure that you have all the necessary items and that they are not damaged. Immediately report anything missing or damaged to your homecare provider.

The standard package should include the following:

1. SmartMonitor 2 PS device 2. Soft Carrying Case 3. Power Supply and Power Cord 4. Parents’ Guide 5. ECG Patient Cable 6. Oximeter Patient Cable 7. Electrodes 8. Lead Wires 9. Electrode Belt 10. Handle/Stand and Screws (screws not shown here) 11. Symbol Reference Card (not shown here) 12. Phone Line Splitter (not shown here) 13. Phone Line Cord (not shown here)

29 Getting to Know the Monitor

8 2 9

% SpO2 % 3

4 7 10

4 0 0 5

RA RL LA 6

30 Getting to Know the Monitor

SmartMonitor 2 PS Features

This section describes the physical features of the SmartMonitor 2 PS device.

Top Panel Features POWER Button The gray POWER button turns the SmartMonitor 2 PS on. When you turn the monitor on, all lights and the alarm come on briefly and the monitor performs a system test. After a pause, monitoring will begin. To turn the monitor off do the following: • Press and hold the blue RESET button.

31 Getting to Know the Monitor

• Press and release the gray POWER button. • Wait 2 seconds, and then release the RESET button.

RESET Button The blue RESET button resets the alarm lights on the SmartMonitor 2 PS. It also silences the Memory Full (or Memory Almost Full) and Low Battery warning alarms. For more information, see the section on Responding to Alarms. The RESET button also answers a ringing modem phone call when in monitoring mode.

Remember that the RESET button will not silence patient or loose lead alarms.

32 Getting to Know the Monitor

Front Panel Features

% SpO2 %

33 Getting to Know the Monitor

Patient Input Connectors Two patient input connectors appear on the SmartMonitor 2 PS. The top connector supports connection of the oximeter patient cable. The bottom connector is for the ECG patient cable.

Display of Values Values for heart rate, breath rate and SpO2 level are viewable from the front panel display. The SpO2 level display may also show “OFF” if no SpO2 sensor is installed when the monitor is turned on.

Values will only appear on the display if your homecare provider has enabled this feature.

Respiration Lights The green respiration light blinks with each breath the SmartMonitor 2 PS detects. The red apnea alarm light will come on if the SmartMonitor 2 PS detects a pause in breathing that is longer than the limit set by your physician.

34 Getting to Know the Monitor

Heart Lights The green heart light blinks with each heartbeat the SmartMonitor 2 PS detects. The red high alarm light comes on when the SmartMonitor 2 PS detects a heart rate higher than the limit set by your physician. The red low alarm light comes on when SmartMonitor 2 PS detects a heart rate lower than the limit set by the physician.

SpO2 Lights The SpO2 light will appear green when the probe is connected to the patient and is monitoring the SpO2 level. If the probe is disconnected or not transmitting a signal, the SpO2 light will appear red. The red high light comes on when the SmartMonitor 2 PS detects an SpO2 level higher than the limit set by the physician. The red low light comes on when the SmartMonitor 2 PS detects an SpO2 level lower than the limit set by the physician.

Speaker The SmartMonitor 2 PS speaker allows you to hear any alarm that sounds during monitoring. This speaker uses two internal buzzers, and you may notice two slightly different tones when the device is alarming.

35 Getting to Know the Monitor

System Lights The lights across the bottom of the front panel indicate if the SmartMonitor 2 PS is working properly:

Light Indicates

Power The power to the SmartMonitor 2 PS is turned on.

Charger The power supply is plugged into the SmartMonitor 2 PS. (Blinking if charging battery; solid if battery is fully charged.)

Low battery The battery power is low and needs to be charged.

The SmartMonitor 2 PS memory is full or almost full. Memory full

Loose lead An electrode, cable, or lead wire connection is loose at one of the plug-in-ports or the electrodes are not making good contact with the patient’s skin.

36 Getting to Know the Monitor

Side Panel Features

Self-Test Connector You use the Self-Test Connector when performing a Functional Self-Test to make sure the lead wires, patient cables, and SmartMonitor 2 PS are working properly. See the section, Performing a Functional Self-Test for more information.

37 Getting to Know the Monitor

Back Panel Features

Nurse Call This feature is for institutional use only.

38 Getting to Know the Monitor

Modem (Optional) The SmartMonitor 2 PS may be equipped with a modem to transfer the SmartMonitor 2 PS memory to the baby’s homecare provider. See the section Transferring SmartMonitor 2 PS for more information. See the sections FCC Part 15 and Industry Canada CS-03 Notice for information on connecting the modem to the telephone line.

DC Power Use the DC Power connector with the power supply. Whenever the SmartMonitor 2 PS is not in portable use (on battery power only), it should be connected to the power supply.

I/O Connector This connector connects the SmartMonitor 2 PS with other devices.

Stand The SmartMonitor 2 PS comes with a removable handle. The handle also acts as a stand that elevates the front panel display when the monitor is placed on a flat surface.

insert screws here

Setting Up the SmartMonitor 2 PS for Respiration, Heart, and SpO2 Monitoring After you unpack your SmartMonitor 2 PS and make sure you have all the parts, follow the steps listed below to set it up:

Step 3: Connect the Lead Wires to the ECG Patient Cable. The larger end of the ECG patient cable has three openings, marked LA (black), RL (green) and RA (white). • Insert the white lead wire into the opening marked RA. • Insert the black lead wire into the opening marked LA. • Firmly push each lead wire in until the socket snaps into place.

40 Respiration, Heart and SpO2 Monitoring

Step 2: Connect the ECG Patient Cable to the SmartMonitor 2 PS. • Insert the round end of the ECG patient cable into the bottom round connector found on the front of the SmartMonitor 2 PS. • Line up the notch and arrows on the connector and push, with the arrows facing up, until you feel the connector snap into place. • To remove the ECG patient cable, grasp it at the end of the patient input connector and gently pull back. You should feel the connector body slide back and unlock the connector as you pull.

Do not twist or turn the ECG patient cable to remove it from the SmartMonitor 2 PS as this may damage the ECG patient cable and/or monitor.

The ECG patient cable should not be

4 0 0 5 placed over the top of the crib rail. The RA RL LA cable should be placed between the vertical bars.

41 Respiration, Heart and SpO2 Monitoring

When you need to remove a lead wire, grasp and pull at the strain relief area located near the connecting tip. Do not grasp the wire.

Use of the third (green – RL) electrode and lead wire is normally not required but may help reduce excessive false low heart rate alarms.

42 Respiration, Heart and SpO2 Monitoring

Step 4: Connect the Lead Wires to the Electrodes.

• Insert the black LA lead wire into one electrode. • Insert the white RA lead wire into the other electrode. • Make sure the metal tips of the lead wires are fully inserted into the electrodes.

Your homecare provider may provide you with stick-on electrodes that have the lead wires already attached. In this case, this step is not necessary. Refer to “Disposable Self-Adhesive Electrodes” later in this section.

43 Respiration, Heart and SpO2 Monitoring

Step 5: Attach the Electrodes to the Infant Belt. • Place the electrode belt on a flat surface. • Lay your baby on the belt so that the belt is aligned with the baby’s nipples. (See illustration.) • Place the electrodes, Velcro-side down, on either side of the belt as follows: o Place the electrode with the white lead wire on the baby’s right side. o Place the electrode with the black lead wire on the baby’s left side.

• Place the electrodes far enough apart so that when the belt is wrapped around the baby, the electrode will be located along the mid-line of the side just below or lined up with the nipples. • Be sure the lead wires and ECG patient cable are leading down and away from the baby’s face and neck. (See illustration.)

44 Respiration, Heart and SpO2 Monitoring

Baby’s Baby’s right side left side The white lead wire location is illustrated with a white electrode.

Step 6: Wrap the Electrode Belt Around the Baby. Wrap the belt around the baby’s chest and fasten it with the Velcro tab. The belt should be snug enough so that you can only insert two of your fingers (with your hand lying flat against the baby) between the belt and the baby.

45 Respiration, Heart and SpO2 Monitoring

With newborns and very small babies, you may need to shorten the belt by cutting off a part of the end. Be sure to leave enough room to fasten the belt securely.

46 Respiration, Heart and SpO2 Monitoring

These steps describe only one method for electrode placement and positioning. Your homecare provider may show you another method.

• Insert the black LA lead wire into the Velcro side of one electrode. Place the electrode with the black lead wire on the baby’s left side. • Insert the white RA lead wire into the Velcro side of one electrode. Place the electrode with the white lead wire on the baby’s right side.

47 Respiration, Heart and SpO2 Monitoring

• Wires must be placed on the infant so they are oriented away from the baby’s head and neck.

Note downward wire placement in the above illustration.

Remove the electrode belt and the lead wires when your baby is not being monitored. Long-term wear may be uncomfortable.

Disposable Self Adhesive Electrodes Follow the steps below if you are using disposable electrodes. • Attach lead wires to the Self Adhesive Electrodes if not pre-attached. • Ensure that the infant’s skin is clean and dry. • Place the electrode with the white lead wire on the baby’s right side, along the mid-line of the side, two finger widths below or lined up with the nipples. • Place the electrode with the black lead wire on the baby’s left side, along the mid-line of the side, two finger widths below or lined up with the nipples. • An electrode belt is not needed with disposable electrodes.

48 Respiration, Heart and SpO2 Monitoring

Use of the third (green – RL) electrode and lead wire is not normally required but may help reduce excessive false low heart rate alarms. Place the green electrode along the outside of the baby’s upper thigh.

Do not use oils, lotion, or powder on the area of skin on which the electrodes will be placed.

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Step 7: Connect the Oximeter Patient Cable to the SmartMonitor 2 PS. • Insert the round end of the oximeter patient cable into the top round connector found on the front of the SmartMonitor 2 PS.

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• Line up the notch (identified by the red dot) on the connector, and push until you feel the connector snap into place. • To remove the oximeter patient cable, grasp it at the base of the patient input connector and gently pull back. You should feel the connector body slide back and unlock the connector as you pull.

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Do not twist or turn the oximeter patient cable to remove it from the SmartMonitor 2 PS as this may damage the oximeter patient cable and/or monitor.

The oximeter patient cable should not be placed over the top of the crib rail. It should be placed between the vertical bars.

If the oximeter patient cable or probe is not connected when the monitor is turned on, the % (percent) display will show “OFF” and SpO2 alarms will not sound. If the sensor is connected while the monitor is on, the SpO2 function will resume normal operation from that point including SpO2 alarms.

Step 8: Connect the Sensor to the Oximeter Patient Cable; Connect the Sensor to the Baby. The SmartMonitor 2 PS can be used with one of three compatible Masimo sensors for use in monitoring patients’ SpO2 levels: • LNOP NeoPt – Neonatal Preterm Single Patient Adhesive Sensor • LNOP Neo – Neonatal Single Patient Adhesive Sensor • LNOP Pdt – Pediatric/Slender Digit Single Patient Adhesive Sensor

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Please see the instructions packaged with the sensors for directions.

Step 9: Connect the Power Supply. • Insert the connector of the power supply into the socket on the back panel of the SmartMonitor 2 PS. (See Illustration.) • The flat side of the connector faces upward. • Push until the connector is fully inserted. A gentle tug on the connector will confirm that it is locked in place. • Plug the power cord into the power supply. • Plug the power supply into a power outlet. The green charge light on the monitor will now come on.

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The power supply connector must be plugged into the SmartMonitor 2 PS DC power input as shown to the left.

• To remove the power supply from the SmartMonitor 2 PS, grasp the power supply connector at its base and gently pull back. You should feel the connector body slide back and unlock the connector as you pull. Do not twist or turn the power cable to remove it from the monitor as this may damage the power supply and/or monitor.

54 Respiration, Heart and SpO2 Monitoring

When the SmartMonitor 2 PS is not being used portably, keep the power supply connected and plugged into an AC outlet at all times. Ensure that the AC outlet has been installed to conform to the National Electrical Code―i.e., a licensed electrician. The batteries cannot be overcharged. The green charger light stays on as long as the charger is connected.

Do NOT use the device if the power cord is damaged. Contact your homecare provider.

Responding to Alarms Patient Alarms

A patient alarm indicates that your baby’s breathing, heart activity or SpO2 level is outside the limits prescribed by your physician. The information in this section can help you respond appropriately to patient alarms. Read this section carefully. If you have any questions, please contact your homecare provider.

Testing the Alarm

Before you use the monitor, test to see if you can hear the alarm in different rooms while there is noise in your house.

Caution: Be aware that the alarm sound is very loud.

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• Always keep the area in front of the speaker clear. • Turn the monitor on (without the baby attached) to sound the alarm. Make sure you can hear the alarm in different areas of your home.

The SmartMonitor 2 PS contains two buzzers internal to the device that produces the alarm sounds. Due to normal variation in these buzzers, you may notice two slightly different alarm tones as these buzzers are alternated. Intermittent alarm sounds alternate buzzers between beeps, while continuous alarm sounds alternate buzzers every second to produce a continuous sound. If the alarm sound changes such that one of the two buzzers no longer functions, contact your homecare provider immediately.

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If an Alarm Sounds: Patient Alarms

If an alarm sounds while you are monitoring your baby, check your baby first. Then follow the instructions below to respond to lights and alarms. Always check your baby’s skin color. Is it normal? Always check to see if your baby is breathing. If your baby is not breathing, intervene and provide stimulation as you have been instructed.

Light Alarms Check Baby’s Respond Like This Condition Red Apnea Intermittent Skin color is pale Respond as instructed by your physician and/or Low (1 beep/ or blue. Baby is or in your CPR class. (Heart) sec) not breathing or is An example of your response could be choking. as follows: • Gently pat the baby. The baby may start breathing and correct the cause of the alarm on his/her own. • If the baby does not start breathing start physical stimulation immediately.

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Light Alarms Check Baby’s Respond Like This Condition • If the baby starts breathing, note it on your log sheet. • Press the RESET button to reset any alarm lights.

Red Apnea Intermittent Baby is • Wait for a few seconds. Watch to see and/or Low (1 beep/ sec.) responsive and is if the baby’s breathing and color (Heart or breathing. remain normal. Color is good. • If the alarm continues, see section SpO2 ) Reducing False Alarms. • Check the monitor to see which light is on. Note it on your log sheet. • Check the sensors. Red High Intermittent Baby is crying. • If the baby has frequent high heart (Heart) (2 beeps/ rate alarms not associated with sec.) crying, notify the physician. • Calm the baby. • Check the monitor to see which light is on. Note the light on your log sheet.

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Light Alarms Check Baby’s Respond Like This Condition Red Low SpO2 Intermittent Skin color is pale Use response under apnea/low heart (1 beep/sec) or blue. Baby is rate above. not breathing or choking.

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Light Alarms Check Baby’s Respond Like This Condition

Skin color is pale Observe the baby closely and respond or blue. Baby is as instructed by the physician or in your breathing. CPR class. If the condition does not improve, notify the physician or EMS.

Check oxygen cannula and oxygen delivery device. Increase oxygen as ordered by the physician. Notify the physician or EMS immediately if the condition does not improve or recurs frequently. Record alarm on log sheet.

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Light Alarms Check Baby’s Condition Respond Like This Red Intermittent Skin color is pale or Use response under apnea/low heart rate Low (1 blue. Baby is not above. SpO 2 beep/sec) breathing or choking.

Skin color is pale or blue. Baby is breathing. Observe the baby closely and respond as instructed by the physician or in your CPR class. If the condition does not improve, notify the physician or EMS. If the baby is receiving supplemental oxygen. Check oxygen cannula and oxygen delivery device. Increase oxygen as ordered by the physician. Notify the physician or EMS immediately if the condition does not improve or recurs frequently. Record alarm on log sheet.

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Light Alarms Check Baby’s Respond Like This Condition Skin color is Wait a few seconds. Watch to see if the baby’s pink, baby is breathing and color remains normal. If the alarm breathing. continues, see the section “Reducing False Alarms.” Check the sensors. Skin color is pink, baby is breathing.

Red Intermittent Skin color is Note the alarm on the log sheet and report to the High (2 beeps/ pink, baby is homecare provider or physician as instructed. breathing. SpO2 sec)

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Light Alarms Check Baby’s Respond Like This Condition Red Loose Continuous Baby is breathing • Check the connections between the Lead and is responsive. electrodes, lead wires, ECG patient cable, Color is good. and the monitor. • If something has come loose, reconnect it and press the RESET button. The alarm should stop. • If the alarm continues, see the section “Performing a Functional Self Test.” Red Loose Continuous Baby is breathing • If the monitor passed the Functional Self Lead and is responsive. Test, turn off the monitor. Then, check the Color is good. following items: • The electrodes − They should be clean and there should be no cracks on the surface..

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Light Alarms Check Baby’s Respond Like This Condition • The baby’s skin − Make sure that where the electrodes are placed is clean and free from oil, lotions, and perspiration. • The electrode belt − Make sure it is snug and is keeping the electrodes in place.

Red Continuous Baby is breathing Check the connections between the SpO2 SpO2 and is responsive. probe, oximeter patient cable and monitor. If Light Color is good. something has come loose, reconnect it and press the RESET button. The alarm should stop.

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System Alarms

A system alarm indicates that the monitor may not be functioning properly or at optimum capacity. The information in this section will help you respond appropriately to system alarms. When a SmartMonitor 2 PS system alarm occurs, one of the lights on the front panel will come on.

If this And this condition It means... light is exists on Power Continuous green Normal operation. The green power indicator light will come on light, no alarm and stay on for as long as the monitor is on. Charger Continuous or Normal operation. The green charger light will come on and blinking green blink when the battery is charging and stay on when the battery light, no alarm is fully charged while the power supply is plugged into an active outlet and connected to the SmartMonitor 2 PS.

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If this And this condition It means... light is exists on Low Flashing yellow This is a warning that the battery voltage is very low and should Battery light, continuous be recharged soon. (See “Charging the Battery” in this alarm manual.) Press the RESET button to temporarily silence the alarm. The alarm will resound in two minutes if the monitor has not been plugged in. The yellow light will continue to flash.

This is a warning that the battery is too low for the Continuous yellow SmartMonitor 2 PS to operate properly. The SmartMonitor 2 PS light, continuous must be recharged. Turn the monitor off. Then, recharge the alarm battery. (See “Charging the Battery” in this manual.) If you do not reconnect the power supply, the system will automatically shut down.

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If this And this condition It means... light is exists on Memory Flashing yellow When the SmartMonitor 2 PS’s Memory Almost Full parameter Full light, continuous is reached, the Memory Full light will flash. The alarm will alarm sound continuously. (The alarm will sound only if your homecare provider programs your SmartMonitor 2 PS to do so at the 50% full or at 80% full). Press the RESET button to Flashing yellow silence the alarm. The light will blink every second. light, no alarm

Memory Almost Full is a warning condition. You can continue monitoring. Please contact your homecare provider to resolve the alarm. Note: the Memory Almost Full alarm will sound every time the monitor is powered off and back on.

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If this And this condition It means... light is exists on Memory Continuous yellow SmartMonitor 2 PS memory is 100% full. Press the RESET Full light, continuous button to silence the alarm. The light will stay on continuously. alarm Then contact your homecare provider to download the data

from the monitor.

The Memory Full alarm will sound every time the monitor is powered off and then back on.

The alarm will sound only if your homecare provider programs your SmartMonitor 2 PS to do so.

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If this And this condition It means... light is on exists Loose Continuous yellow The yellow loose lead light and the alarm may sound Lead light and continuously when there is a problem with any of the following: continuous alarm • Lead wires • Electrodes • Electrode belt • Patient cable, or • Connections between the baby’s skin, and the electrodes, the lead wires, the patient cable, and the SmartMonitor 2 PS.

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If this And this condition It means... light is on exists

Loose Continuous yellow If you correct the problem, the alarm will stop. However, the light and no alarm yellow light remains on until you press the RESET button. Lead

Power Continuous green Check the display on the bottom of the monitor for error light, continuous messages.

alarm, with no If there are no error messages, the SmartMonitor 2 PS was other lights lit turned off improperly causing a sibling alarm. To resolve: • Press and hold the blue RESET button. • Press and release the gray POWER button. • Wait two seconds, and then release the RESET button.

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If this And this condition It means... light is on exists

All Lights All lights are Check the display on the bottom of the monitor for error blinking and the messages. If there is an error message, enter it in on your log alarm sounds sheet. intermittently Turn the monitor off and then back on. If the monitor functions normally continue to use the monitor. If your monitor does not function normally, contact your homecare provider to service the monitor.

SpO2 Continuous Check that the SpO2 probe has not become dislodged from the red/orange light patient or that the probe has not been disconnected from the and continuous monitor or the oximeter patient cable. If you correct the alarm (if problem, the alarm will stop. However the red light remains on enabled) until you press the RESET button.

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Reducing False Alarms

Proper electrode placement will minimize false alarms.

• Make sure the electrodes are placed along the mid-line of the side, two finger widths below or lined up with the nipples. • If using the black reusable electrodes with the Velcro belt, make sure that the belt is quite snug. Place the electrodes far enough apart so that when the belt is wrapped around the baby, the electrode will be located along the mid-line of the side, two finger widths below or lined up with the nipples. • The skin should be clean and dry; if the skin is unusually dry, you may add a few drops of moisture (water) to the baby’s skin prior to electrode belt placement. • When using the black reusable electrodes, make sure that the electrode surface is clean. • Use of the third (green – RL) electrode and lead wire is normally not required but may help reduce excessive false low heart rate alarms. Place the green electrode along the outside of the baby’s upper thigh.

• Check for correct placement of the SpO2 (oxygen) sensor.

Do not place electrodes on the top of your baby’s chest. This may result in false alarms.

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Baby’s Baby’s

right side left side

The white lead wire location is illustrated, above, with a white electrode.

Monitoring Your Baby Turning on the SmartMonitor 2 PS

You have properly set up your SmartMonitor 2 PS, and understand how the monitor functions and how to respond to alarms. You are now ready to begin monitoring your baby's breathing, heart activity, and SpO2 level according to the schedule prescribed by the physician.

Push the POWER button. The SmartMonitor 2 PS performs a system check. The lights on the front of the SmartMonitor 2 PS will come on briefly and the alarm will beep twice. Within 10 seconds, the green respiration and heart lights begin to blink. If the lights do not blink, check that you have attached the electrode belt properly to the baby, that the lead wires are pushed in, and that the cables are connected. The SpO2 light will change from red to orange to green.

Once your baby is properly connected to the SmartMonitor 2 PS and the power is on, the following should occur: • The green (battery) charger light is on (solid or blinking). • The green power light is on. • The green respiration light and green heart light are blinking. The SpO2 light is on (green). • LEDs display numeric values when the display is enabled. • All other lights should be off. • If the lights do not blink, refer to the steps found in the Setting up the SmartMonitor 2 PS section in this manual. Be sure you have followed all instructions.

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• If the alarm does not beep twice or all LEDs do not turn on after the POWER button is pushed, contact your homecare provider immediately.

Turning off the Monitor - Sibling Alarm

The SmartMonitor 2 PS has a built-in safety feature called a sibling alarm. If the monitor is not turned off in a specific sequence, the green power light will remain on and the alarm will sound continuously. This safety feature makes sure the power is not accidentally turned off. To turn the SmartMonitor 2 PS off: • Press and hold the blue RESET button. • Press and release the gray POWER button. • Wait two seconds, and then release the RESET button.

When the SmartMonitor 2 PS is turned off without pushing the RESET button first, the green power light will remain on and the Sibling Alarm will sound. To silence the Sibling Alarm: • Press the POWER button, and make sure that the power light is illuminated. • Press and hold the blue RESET button. • Press and release the gray POWER button. • Wait two seconds, and then release the RESET button. • To resume monitoring, press the gray POWER button.

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Turning off the Monitor – System Alarms

If there is an error code number displayed on the bottom LCD of the monitor, this may indicate an internal software error. In this case, a special power off procedure is required.

Press and hold the RESET button. While still holding down the RESET button, press and hold the POWER button. Hold both buttons down for five seconds. Release the POWER button; continue to hold the RESET button until the monitor turns off.

This power-off procedure is also required if the battery is drained.

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Monitoring Your Baby's Breathing

Respiration Light/Display The green respiration light will blink in rhythm with each breath that the Respiration Light SmartMonitor 2 PS detects. The light should blink only once for each SpO % breath, although it may flash more 2 % times when your baby is moving.

Your baby’s average respiration rate will appear on the front panel display above BrPM, when the display is enabled.

Listen and watch your baby breathe. If the respiration light flashes more times or fewer times than your baby breathes, contact your homecare provider immediately.

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Apnea Alarm Light When the SmartMonitor 2 PS detects a pause in breathing longer than the limit set by your physician, the following will % SpO occur: 2 %

The red apnea light will come on, and the alarm will beep once every second. When the SmartMonitor 2 PS detects breathing again, the beeping alarm stops. The red light will stay on until you press the RESET button.

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Low Breath Rate. Your homecare provider may have set your SmartMonitor 2 PS to signal Low Breath Rate. If so, the following will occur: • The breath rate falls below the setting, but pauses are short and do not cause an apnea alarm. • The apnea light will blink twice each second, and the alarm will beep once each second. During a Low Breath Rate alarm, if the SmartMonitor 2 PS detects a pause in breathing longer than the limit set by your physician, the apnea light will change from flashing to constant.

Contact your homecare provider immediately if apnea alarms occur while the baby is breathing.

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Monitoring Your Baby's Heart Activity

% SpO2 %

Heart Rate Display Heart Rate Light/Display The green light marked heart blinks with each heartbeat the SmartMonitor 2 PS detects.

The patient’s average heart rate will appear on the front panel display above BPM when the display is enabled.

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High Heart Rate Alarm Light SmartMonitor 2 PS determines if your baby’s heart rate is higher than the limit set by your physician. The monitor will alert you by the following: • The red light marked high will come on and the alarm beeps twice each second. • The beeping alarm stops when that condition no longer exists.

The red light will stay on until you press the blue RESET button.

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Low Heart Rate Alarm Light When the SmartMonitor 2 PS determines that your baby’s heart rate is lower than the limit set by your physician, the following will happen: • The red light marked low heart rate will come on. • The alarm beeps once every second. • The beeping alarm stops when that condition no longer exists.

The red light stays on until you press the blue RESET button.

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Monitoring Your Baby’s Oxygen Saturation Level

84 Monitoring Your Baby

SpO2 Light/Display The SpO2 light will appear solid green when the probe is connected to the patient and is monitoring the SpO2 level. If the probe is disconnected or not transmitting a signal, the SpO2 light will appear solid red/orange. This light may briefly change to orange when the sensor is first applied or adjusted. Your baby’s average SpO2 level will appear on the front panel display above % when the display is enabled.

If you are not monitoring oxygen saturation levels, the LCD display shows “OFF.”

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High SpO2 Alarm Light When the SmartMonitor 2 PS determines that the baby’s SpO2 level is higher than the limit set by the physician, the following will happen:

• The red light marked High SpO2 Alarm Light will come on, and the alarm beeps twice each second. • The beeping alarm stops when the condition no longer exists.

The red light stays on until you press the blue RESET button.

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Low SpO2 Alarm Light When the SmartMonitor 2 PS determines that the baby’s SpO2 level is lower than the limit set by the physician, the following will happen:

87 Monitoring Your Baby

• The red light marked Low SpO2 Alarm Light will come on, and the alarm beeps once each second. • The beeping alarm stops when the condition no longer exists.

The red light stays on until you press the blue RESET button.

Portable Operation of the SmartMonitor 2 PS The SmartMonitor 2 PS is designed for portable use. When the power supply is not used, the monitor relies on the previously charged internal battery for power. The green charger light will be off during portable operation.

Respironics recommends that the SmartMonitor 2 PS be used with the power supply whenever possible. However, when the monitor is used without the power supply, the SmartMonitor 2 PS is fully functional. All alarms are operational. With a fully charged battery, the monitor will run for 15 hours. The amount of time to completely recharge a fully depleted battery is six hours.

Charging the SmartMonitor 2 PS

Battery: As a rule, a fully charged battery can operate for 15 hours. This may vary, however, depending on the level of use, number of alarms, and other factors. When the low battery light comes on, you should recharge the battery immediately. A fully drained battery should be recharged for six hours. When you need to recharge the SmartMonitor 2 PS battery, follow the steps below:

• Insert the connector of the power supply into the socket on the back panel of the SmartMonitor 2 PS. (See illustration.) The flat side of the connector faces upward. • Plug the power supply into a power outlet. The green charger light comes on solid if the battery is fully charged or blinks if the battery is charging.

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Fully drained batteries need about 6 hours to recharge.

If the SmartMonitor 2 PS is turned on, the yellow low battery light blinks until the minimum charge level is reached. Then, the yellow light goes off.

Only use Respironics batteries. The power supply connector must be plugged into the SmartMonitor 2 PS DC power input as shown in the illustration above.

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Transferring SmartMonitor 2 PS Information The SmartMonitor 2 PS contains a memory system that automatically records information about each monitoring session. This information can be transferred (or downloaded) to a computer to be reviewed by your physician. You may be involved in the download if your monitor is equipped with a modem or memory card. Whatever method you use, you must transfer data when you get a memory 100% full condition. You may choose to transfer data at any time or whenever you are instructed to do so by your homecare provider or physician.

Modem Download

SmartMonitor 2 PS must be plugged into the electrical outlet and must be powered ON during modem downloads.

There are three ways to download with a modem. The first choice involves the modem automatically calling your baby’s homecare provider. This is called Modem Auto Dial. This doesn’t involve any action on your part other than connecting the monitor to the phone line and electrical outlet. The monitor must be turned on and monitoring your baby for the download to occur. It is important to know that the modem inside the unit may use your phone line. If your homecare provider is going to use this feature, he or she will give you more specific instructions.

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The second choice is called Modem Auto Answer When in Communications mode. With this option, the baby is not being monitored and the device is in Communications mode when the homecare provider calls.

The third option involves the homecare provider calling to the modem built inside the monitor while the baby is being monitored. This is called Modem Auto Answer When Monitoring. The homecare provider will contact you when it is time to transfer the data through the modem. All three methods of modem download appear next.

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Modem Auto Dial

SmartMonitor 2 PS must be plugged into the electrical outlet and must be powered on during modem downloads.

To have SmartMonitor 2 PS call the computer for a download it must be programmed with a host phone number, which is the phone number to be called to connect with the computer as well as the date and time to call. If this feature is going to be used, your homecare provider will have programmed these before you receive the monitor. When the preset time for download approaches or when the memory full light illuminates, follow these instructions:

If there is an emergency and access to the telephone is required while the modem is in use, remove the phone cord from the modem slot and use a working phone.

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• Plug the telephone wire into the modem connector on the back of the SmartMonitor 2 PS. (See illustration.) • Plug the other end of the phone wire into the wall phone jack. • The SmartMonitor 2 PS will continue to monitor your baby during the download. All alarms are functional. • Double-check to make sure that the monitor is plugged into an electrical outlet, and that the power light and charging light are on.

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The monitor will continue calling every 30 minutes, for four hours, until it connects with the computer. If no connection is made, the monitor will try again the next day at the pre-selected time. For example, when the modem is programmed to call at 7 a.m. but fails to make a connection after eight attempts, it will stop trying. The next day at 7 a.m., it will try again. This will continue until a connection is made and the modem has completed a successful download.

Modem Auto Answer in Communications Mode

SmartMonitor 2 PS must be plugged into the electrical outlet and must be powered on during modem downloads.

1. Connect a phone cord from the wall jack to the modem connector on the back of the SmartMonitor 2 PS. 2. Make sure that the monitor is plugged into an electrical outlet and that the charging light is on. 3. To allow the SmartMonitor 2 PS to work with the modem, place the monitor in Communications Mode:

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• Press and hold the blue RESET button. • Press and release the POWER button to turn the SmartMonitor 2 PS on. • Wait until the monitor alarms. • Release the RESET button. Briefly press and release the RESET button again. The SmartMonitor 2 PS bottom display will read “Monitor is in Communication Mode”. • The SmartMonitor 2 PS beeps every 10 seconds whenever it is in the Communications Mode. This is a reminder that the SmartMonitor 2 PS is powered on for working with the computer or modem, but NOT for monitoring the baby.

Do not connect the infant to the SmartMonitor 2 PS when in the Communications Mode; the apnea and heart rate alarms are not operational in this mode.

• The homecare provider should now call to retrieve the information. The phone may ring, but do not answer. The modem answers the call and connects the SmartMonitor 2 PS to the computer through the phone line.

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4. The amount of time to transfer the information will vary. When the transfer is complete, the SmartMonitor 2 PS will beep 5 times. After the transfer, you may disconnect the phone line from the monitor and the phone will work normally. Turn the monitor off in the normal way. • Press and hold the blue RESET button. • Press and release the gray POWER button. • Wait two seconds, and then release the RESET button. • You may now reconnect the baby and resume monitoring.

Modem Auto Answer in Monitor Mode

SmartMonitor 2 PS must be plugged into the electrical outlet and must be powered on during modem downloads.

If there is an emergency and access to the telephone is required while the modem is in use, remove the phone cord from the modem slot and use a working phone.

1. Connect the phone cord from the wall jack to the modem connector on the back of the SmartMonitor 2 PS. 2. Make sure that the monitor is plugged into an electrical outlet and that the charging light is on.

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3. To allow the SmartMonitor 2 PS to work with the modem when the monitor is in monitor mode (the baby is being monitored): • When the homecare provider calls for a download and the phone rings, you should press and hold down the blue RESET button. • Hold down the RESET button until the phone stops ringing indicating the monitor has answered the call. • The amount of time to transfer the information will vary. When the transfer is complete, the SmartMonitor 2 PS will beep 5 times. • After the transfer, disconnect the phone line from the monitor and the phone will work normally.

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Transferring SmartMonitor 2 PS Data to a Memory Card The memory card is a credit-card-sized electronic memory transfer device that transfers monitor data.

All data in the memory card at the time of a download will be overwritten. When you are ready to use the Memory Card to transfer SmartMonitor 2 PS data, follow the steps below: • Make sure the SmartMonitor 2 PS is off. • Unscrew the single screw on the right of the LCD display cover. • Remove cover. • With the Memory Card facing you slide the card into the slot provided on the side panel of the SmartMonitor 2 PS. The location of the memory card logo will be on the bottom edge and facing you. (See illustration.)

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• Press the POWER button ON. After a short delay, the display will read: • INITIALIZING PLEASE WAIT Then, MENU MODE? ENTER PROPER KEY SEQUENCE • Press the keys in the following sequence within 10 seconds: • Press the ENTER button. • The display will read SMARTMONITOR 2 MENU SELECTION.

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• Press the u arrow until you see “Move Data To Card?” • Press the ENTER button. The word NO will begin to blink. To select YES press either arrow button. • Press the ENTER

button. The display will now show “Transferring Data.” Once the transfer is complete the display will change to “Data Transferred.”

Closeup of LCD display on the bottom of the SmartMonitor 2 PS.

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• Turn the monitor power OFF. Press and hold blue RESET button. Press and release gray POWER button. Continue to hold blue RESET button. Once the monitor is powered off, press the black RELEASE button by the memory card to remove it from the monitor.

102

Caring for Your SmartMonitor 2 PS Use the information in this section to care for your SmartMonitor 2 PS.

Use only approved accessories with the SmartMonitor 2 PS.

When necessary, dispose of the SmartMonitor 2 PS and accessories in accordance with local regulations.

Cleaning Instructions Turn the monitor OFF, unplug it from the electrical outlet, and disconnect all accessories before you begin cleaning. Never immerse the monitor or any of the accessories in water or spray cleaner directly on them. Apply water or cleaner to a soft cloth and gently wipe the components to clean them.

• Use a clean cloth and any of the following to clean these Monitor, Power components: Supply and Safety Unscented dishwashing detergent. Lead Wires 3% hydrogen peroxide solution (the kind found in most stores) to clean the monitor. 91% Isopropyl alcohol (the kind found in most stores). 10% bleach solution. Germicidal cloth.

103 Caring for Your Monitor

Electrodes • Do not attempt to clean the disposable style electrodes. • Clean the carbon electrodes with a mild soap and water. • They must be rinsed well to remove any traces of soap film. Soap film can prevent heart and breathing signals from being picked up clearly from the monitor. • Ensure that the electrodes are completely dry before using.

Electrode Belt Wash by hand with a mild soap and water. Rinse thoroughly and air- dry only.

Soft Carrying Case • Although the care label in the carrying case suggests machine washing in warm water, the appearance of the carrying case will change noticeably after washing.

• Respironics recommends that you wipe the case with a damp cloth

or sponge using a light detergent, if necessary. Air-dry only. • Sensors • Follow the instructions packaged with the sensors for information on cleaning.

104 Caring for Your Monitor

Performing a Functional Self-Test The SmartMonitor 2 PS functional self-test checks that all the features of the device are functioning properly. You should perform a functional self-test at least once a week or according to the instructions given by your homecare provider. You should also perform the test: • after a lead wire is changed • after one of the patient cables is changed • when the monitor has been scanned by airport x-ray machines.

To perform the functional self-test, follow the steps listed below:

105 Caring for Your Monitor

• Insert the ECG patient cable into the socket located on the front of the monitor.

• Connect the lead wires to ! the ECG patient cable. Insert the white lead wire into the opening labeled RA. Insert the black lead wire into the opening

labeled LA.

A L

A • Connect the lead wires to R 40 the functional self-test 05 socket on the side panel of the SmartMonitor 2 PS. Insert the white lead wire into the RA opening and then the black lead wire into the LA opening.

• Insert the oximeter patient cable into the socket located on the front of the monitor. • Connect the SpO2 sensor to the oximeter patient cable and place the sensor over your finger.

106 Caring for Your Monitor

• Turn on the monitor. You will hear two short beeps and the lights on the front come on briefly, and then go off. • After all the alarm lights go out, the green power and charger lights remain on and the green heart and respiration lights are blinking. All three numeric displays will begin displaying values. • The heart and respiration lights continue to blink for about 30 seconds. • When the green lights stop blinking, the red low heart light will come on within about seven seconds and the alarm beeps once every second.

• Next, the red apnea light comes on (the amount of time before the red apnea light comes on is determined by the apnea delay parameter selected at the time the monitor was set up) and the low (heart) light remains on. (There should be no green heart or respiration light flashes during this time).

• Remove the SpO2 sensor from your finger. The SpO2 light will turn red and the SpO2 display will show dashes.

• Reapply the SpO2 sensor to your finger. • Follow the instructions in the Self-Test Troubleshooting section, if necessary.

107 Caring for Your Monitor

• Remove the lead wires from the functional self-test socket. To remove the lead wires, grasp and pull the strain relief area located near the connecting tip. Do not grasp the wire. • The loose lead light will come on, and the alarm changes from beeping to continuous. This lets you know the SmartMonitor 2 PS, patient cables, and lead wires are working properly. • Now turn the monitor off. • Press and hold the blue RESET button. • Press and release the gray POWER button. • Wait two seconds, and then release the RESET button.

108 Caring for Your Monitor

Self-Test Troubleshooting Follow the instructions given if any of the described conditions occur. Start the test over once the problem has been corrected. Alarm Condition Solution Low If the low battery light • Turn the monitor off using the correct power off Battery stays on longer than half procedure described in the Turning the Monitor off a minute, the batteries – System Alarms section in this manual. are completely discharged. • Make sure the power supply is plugged into a live power outlet and is properly connected to the monitor. (See Charging the Battery for more information).

• Plug the monitor in for 30 minutes to allow the monitor to charge. This will provide sufficient charge to allow use of the monitor while it continues to charge. (The monitor should remain plugged into an electrical outlet.)

• Allow the SmartMonitor 2 PS battery to recharge for six hours. If the monitor cannot be used

109 Caring for Your Monitor

Alarm Condition Solution because the battery is completely discharged contact your homecare provider.

• To operate the monitor and recharge battery, follow the procedures as described in the next Troubleshooting section under the Condition “No power, battery drained.”

110 Caring for Your Monitor

Alarm Condition Solution

Memory The SmartMonitor 2 PS Press the RESET button to silence the alarm. The Full full memory setting has SmartMonitor 2 PS memory needs to be transferred been reached. and cleared. Contact your homecare provider for specific instructions. Loose Indicates loose or bad Check all connections and/or replace lead wires first, Lead lead wires and/or patient then the patient cable if necessary. cable.

The SmartMonitor 2 PS lights and alarms should respond as just described. If not, contact your homecare provider before monitoring your baby.

Do not use your monitor if the alarm sounds weak or does not activate twice upon initial startup.

111

Troubleshooting Whenever a technical problem occurs which you cannot handle, contact your homecare provider. Do not try to fix the SmartMonitor 2 PS. The following are some common problems:

Problem Possible Cause Instructions Monitor will not Monitor disconnected Plug power supply into monitor and outlet. Operate. from power supply, batteries discharged. No power at outlet. Locate an outlet with power.

Defective power supply. Contact your homecare provider.

Internal part failure. Contact your homecare provider.

112 Troubleshooting

Problem Possible Cause Instructions All lights will Internal error condition If an error number is displayed on the LCD (the flash together detected by LCD is located on the bottom of the monitor), and the alarm SmartMonitor 2 PS. record this information. Contact your homecare will beep in provider. unison with the If there is an internal software error, a special flashing lights. power off procedure is required. Pressing the • Press and hold the RESET button. While still RESET button holding down the RESET button, press and will not silence hold the POWER button. Hold both buttons alarm. down for 5 seconds. • Release the POWER button and continue to hold the RESET button until the monitor turns off.

113 Troubleshooting

Problem Possible Cause Instructions Alarm Sound Incorrect power-off • Press the POWER button, and ensure that Continuous, No sequence. the power light is illuminated. Lights. • Press and hold the RESET button. Press and release the POWER button. Wait two seconds. Then release the RESET button.

Internal part failure. Contact your homecare provider. Alarm Sound No power, battery Connect the power supply. Use Power-Off to Continuous, drained. silence the alarm. Low Battery • Press and hold the blue RESET button. Light remains • Press and hold the gray POWER button. on. Wait five seconds. Then release the POWER button. Prior to use, allow the battery to charge approximately 30 minutes. You may then operate the monitor while it is plugged in. Allow the battery to charge for six hours before using the monitor on battery power. Alarm sounds Internal part failure. Contact your homecare provider. weak. Low battery. Charge battery.

114 Troubleshooting

Loose lead. Connections between Verify that Continuous electrode/sensor lead (a) baby’s skin underneath the alarm; light wires and patient electrodes/sensors is clean, remains on. cables are not properly (b) electrodes/sensors are clean, and made. (c) lead wires are fully inserted into the electrodes/sensors and patient cables.

Replace lead wires, and perform a Functional Self- Defective lead wires. Test. Defective patient Replace patient cables, and perform a Functional cables. Self-Test.

115 Troubleshooting

Unable to AC power not Plug the SmartMonitor 2 PS into an electrical outlet download via connected to during downloads, and make sure charger light is modem. SmartMonitor 2 PS. on. Make sure monitor is not plugged into an outlet operated by a light switch.

Check power supply for damage. Replace power Defective power supply. supply. Connect the phone cord to the modem and to the Phone line not wall phone jack. connected to modem or wall jack. Remove the splitter. Connect the phone cord directly to modem and to wall phone jack. Phone splitter not working.

116 Troubleshooting

SpO2 light Connections between Check all connections. remains red or the sensor, oximeter Verify that orange when patient cable and (a) baby’s skin underneath the sensor is clean, connected to monitor have not been (b) sensor is clean, baby. made properly. (c) connector is fully inserted into the oximeter patient cable, and (d) sensor light is properly aligned.

Defective sensor. Replace sensor. Contact homecare provider.

117 Specifications

Specifications Device Size

Dimensions 5.72 cm x 18.42 cm x 22.86 cm Weight 1.35 kg

Electrical Ratings

AC Power Consumption 100-240VAC 50/60Hz 36W DC Power Consumption 12VDC 3.0Amps max. Li Ion Rechargeable Battery Pack 7.4VDC 4.4AH or greater

Environmental Conditions

Operating Temperature 5°C to 40°C Operating Humidity 15 to 95% non-condensing Storage Temperature -20°C to 60°C Storage Humidity 15 to 95% non-condensing Battery Charge Temperature 5°C to 40°C

118 Specifications

IEC Classification

This device is designed to conform to the following standards: IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment IEC/EN 60601-1-2:2001 (2nd Edition) Immunity for Medical Electrical Equipment The SmartMonitor 2 PS system is classified as follows:

Type of protection against electric shock Class II/Internally Powered Degree of protection against electric shock Type BF Applied Part Degree of protection against ingress of water IPX1 – Drip Proof Mode of operation Continuous

EMC Requirements

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance

119 Specifications

RF emissions Group 1 This device RF emissions are uses RF CISPR 11 energy only for its internal function. Therefore, its very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions Class B This device is suitable for use in all CISPR 11 establishments, including domestic establishments and those directly connected Harmonic emissions Class A to the public low-voltage power supply IEC 61000-3-2 (not applicable) network that supplies buildings used for domestic purpose. Voltage fluctuations/flicker Complies emissions IEC 61000-3-3

120 Specifications

Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environment - Level Guidance Electrostatic ±6V contact ±6V contact Floors should be wood, concrete or Discharge ±8V air ±8V air ceramic tile. If floors are covered with (ESD) synthetic material, the relative IEC 61000-4-2 humidity should be at least 30%. Electrical fast ±2kV for ±2kV for supply Mains power quality should be that of Transient/burst power supply mains a typical home or hospital IEC 61000-4-4 lines environment. ±1kV for ±1kV for input/output input/output lines lines Surge ±1kV ±1kV differential Mains power quality should be that of IEC 61000-4-5 differential mode a typical home or hospital mode environment. ±2kV common ±2kV common mode mode

121 Specifications

Voltage dips, <5% UT <5% UT Mains power quality should be that of short (>95% dip in (>95% dip in UT ) a typical home or hospital interruptions UT ) for 0.5 for 0.5 cycles environment. If the user of the device and voltage cycle 40% UT requires continued operation during variations on 40% UT (60% dip in UT) for power mains interruptions, it is power supply (60% dip in 5 cycles recommended that the device be input lines UT) 70% UT (30% dip in powered from an uninterruptible IEC 61000-4-11 for 5 cycles UT) for 25 cycles power supply or a battery. 70% UT (30% <5% UT (>95% dip dip in UT) for in UT) for 5 sec 25 cycles <5% UT (>95% dip in UT) for 5 sec Power 3 A/m 3 A/m Power frequency magnetic fields frequency should be at levels characteristic of a (50/60 Hz) typical location in a typical home or magnetic field hospital environment. IEC 61000-4-8

Note: UT is the AC mains voltage prior to application of the test level.

122 Specifications

Guidance and manufacturer’s declaration – electromagnetic immunity The SmartMonitor 2 PS is intended for use in the electromagnetic environment specified below. The user of the SmartMonitor 2 PS should make sure that it is used in such an environment. Immunity test IEC 60601 test Compliance level Electromagnetic environment - guidance level (FDA) Portable and mobile RF communications equipment should be used no closer to any part of the monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance

Conducted RF 3 Vrms 3 V IEC 61000-4-6 150 kHz to 80 d = 1.2 P MHz outside ISM a Bands

10 Vrms 10 V 150 kHz to 80 d = 1.2 P 80 MHz to 800 MHz MHz in ISM bandsa d = 2.3 P 800 MHz to 2.5 GHz Radiated RF 10 V/m 10 V/m IEC 61000-4-3 80 MHz to 2.5 where P is the maximum output power rating of

123 Specifications

GHz the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,c should be less than the compliance level in each frequency range.d Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHZ to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b The compliance levels in the ISM frequency bands between 150 kHz and MHz and in the frequency range 80 MHz and 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an individual factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. c Field strength fro fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SmartMonitor 2 PS is used exceeds the applicable RF compliance level above, the SmartMonitor 2 PS should be observed to verify normal operation. If abnormal performance is observed, additional measures mat be necessary, such as re-orienting or relocating the SmartMonitor 2 PS. d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

124 Specifications

Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Device The Device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user of the Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Device as recommended below, according to the maximum output power of the communications equipment. Separation Distance According to Frequency of Transmitter (meters) Rated 150 kHz to 150 kHz to Maximum 80 MHz 80 MHz 80 MHz to Output 800 MHz to 2.5 GHz Power of outside in ISM 800 MHz Transmitte ISM bands bands d = 2.3 P r (Watts) d =1.2 P d =1.2 P d =1.2 P 0.01 0.12 0.12 0.12 0.23 0.1 0.38 0.38 0.38 0.73 1 1.2 1.2 1.2 2.3 10 3.8 3.8 3.8 7.3 100 12 12 12 23

125 Specifications

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power of the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz and 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

126

Functional Self-Test - A user-performed Glossary test to verify that the SmartMonitor 2 PS, Apnea – The cessation of breathing patient cables, and lead wires are working (respiration). properly. Central apnea – No respiratory effort, Heart rate – The number of heart beats per caused when the brain fails to send the minute. appropriate signals to the breathing Impedance - The opposition offered by an muscles to initiate respirations. electrical circuit to the flow of an alternating Obstructive apnea – Cessation of current, measured by the ratio of the airflow into or out of the mouth or nose effective applied voltage to the effective although efforts to breathe continue. current. This is the method used by Such obstructions may result from a SmartMonitor 2PS to detect your baby’s spasm of the larynx, reflux, or other respiration. causes. LA Connection - The opening on the ECG Cardiopulmonary Resuscitation (CPR) - patient cable marked LA is the connector for A procedure used after cardiac arrest in the black lead wire. which cardiac massage, mouth-to-mouth Modem - A device that allows the homecare resuscitation, and drugs are used to restore provider or hospital to work with a monitor breathing. through telephone lines. Electrode - A conductor used to establish Oximeter – A photoelectric device that electrical contact between the monitor and measures the amount of oxygen and other the baby’s skin. fluids in the blood.

128 Glossary

% (Percent) SpO2 – a measurement of how much oxygen is contained in the blood. Usually measured via a finger, toe, or ear sensor. RA Connection - The opening on the ECG patient cable marked RA is the connector for the white lead wire. Respiration - The act of inhaling and exhaling air. RL connection - Use of the third (green – RL) electrode and lead wire is normally not required but may help reduce excessive false low heart rate alarms. This is placed on the outer thigh of the infants left leg.

SpO2 Levels – A measurement of how much oxygen is contained in the blood. Strain Relief Area - Located at the connecting tip of the lead wires or cables, this area has added insulation surrounding the wires to prevent breakage when handled. This area is to be grasped when removing lead wires.

129

SmartMonitor 2 PS Clinical Summary

NOTE: The following study involved the SmartMonitor 2 predicate device and is being used as the basis for performance evaluation of the SmartMonitor 2 PS.

The SmartMonitor 2 was evaluated in a clinical study according to the most recent FDA recommendations. These recommendations are available in the “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA,” released in 2002.

The study was completed with babies less than one year of age who were in need of an apnea monitor. The recorded information was analyzed to identify the number of 10-second apnea events detected by the monitor. The same events were then scored by a physician. SmartMonitor 2 sounded an alarm for 51 of 100 apnea events scored by the physician and did not alarm for 49 scored apnea events. Out of every 100 alarms, 54 sounded when the baby was breathing normally. Forty-six alarms actually indicated apnea. On average, the monitor sounded a false alarm once every 67 minutes.

With all apnea monitors, you can expect a certain amount of false alarms. Often times, these false alarms are caused by the baby’s movement and the amount of contact made by the electrodes on the baby’s skin. In the home environment, your baby’s apnea monitor will be set to detect and alarm for apneas that are greater than 15 to 20 seconds rather than the 10 seconds used in the clinical study. When an apnea event occurs that is longer than 15 to 20

130 Clinical Summary

seconds, often the baby’s heart rate will slow down. As an added safety feature, SmartMonitor 2 also detects and alarms for this slowdown in the baby’s heart rate.

If you would like additional clinical information about the function of the monitor prescribed for your baby, contact your homecare provider or your physician.

131

Index

AC, 3, 55, 116, 122 apnea events, 130 accessories, 5, 11, 103 apnea light, 34, 79, 80, 107 accessory, 9 apnea monitor, 1, 130 Accidental Power-Off, 15 apneas, 7 air conditioners, 6 arterial catheter, 10 air conditioning, 8 attention, 16 air-dry, 104 batteries, 55, 109, 112 airport, 7 battery, 66, 89 airport security check, 11 battery charge temperature, 118 airport x-ray machines, 105 battery pack, 3, 118 alarm, 2, 5, 9, 13, 31, 35, 58, 65, 67, 68, 79, black lead wire, 44, 48, 106 83, 107, 108, 130 bleach, 103 alarm lights, 59 blood oxygen levels, 13 alarms, 7, 15, 75, 89, 94, 96 blood pressure cuff, 10 All Lights, 72 breath rate, 34 ambulance, 7 breathing, 11, 13, 34, 56, 58, 60, 62, 64, 75, anesthetics, 4 79, 104 apnea, 4, 6, 60, 62, 96, 130 breathing effort, 2, 13 Apnea, 14 Breaths Per Minute, 19 apnea alarm, 80 BrPM, 78 apnea delay parameter, 107 buzzers, 57

132 Index

cannula, 61, 62 computers, 6 Carboxyhemoglobin (COHb), 10 conductive floor coverings, 8 cardiac, 1 conductive material, 6 Cardiopulmonary Resuscitation (CPR), 4 conductive parts, 10 carrying case, 104 Connector Position, 21 Carrying Case, 29 connectors, 8 caution, 11 cordless telephones, 6 cellular phones, 6 CPR, 58, 61, 62 charger, 107 crib, 6 Charger, 66 crying, 60 charger light, 75, 89 DC Power, 39 Charger Light, 18 death, 4 charging the battery, 89 defibrillate, 4 choking, 4, 58, 60, 62 dishwashing detergent, 103 cleaning, 103 disposable electrodes, 48 cleaning agents, 4 download, 94, 99 cleaning instructions, 9 downloads, 116 cleaning solutions, 9 draperies, 6 clinical study, 130 Drip Proof Equipment, 21 Communication Mode, 96 earth, 8, 10 Communications Mode, 7, 95 ECG patient cable, 34, 40, 45, 64, 106 compliance, 119, 121 ECG Patient Cable, 29 components, 11 ECG patient cables, 9 computer, 91, 93, 96 electric blankets, 6

133 Index

electrical appliances, 6 ESD Warning Symbol, 20 electrical outlet, 5, 91, 94, 97, 103, 109, 116 ethylene oxide, 9 electrical shock, 5, 8 Explosion hazard, 8 electrical storms, 11 extension cord, 6 electrician, 55 false alarm, 130 electrode, 36, 43, 47 false alarms, 73 electrode belt, 44, 65, 73, 75 FDA, 130 Electrode belt, 70 fire, 6 Electrode Belt, 29 fire hazard, 5 electrode gels, 4 flammable anesthetics, 8 electrodes, 8, 10, 11, 13, 44, 64, 73, 104, flammable gases, 5 130 flammable substance, 8 Electrodes, 29, 70 flammable substances, 4 electromagnetic emissions, 119 flicker emissions, 120 electromagnetic environment, 119, 121 foreign matter, 11 electronic components, 12 front panel, 36, 66 emergency, 3, 93, 97 front panel display, 34, 78, 81, 85 emissions, 11 functional oxygen saturation, 1 emissions test, 119 functional self test, 105 EMS, 61, 62 Functional Self Test, 64 ENTER button, 100, 101 functional self-test, 11, 105 error messages, 71 Functional Self-Test, 37 error number, 113 Germicidal cloth, 103 ESD warning symbol, 8 grounded path, 6

134 Index

handle, 5 immunity test, 121 Handle, 29 impedance, 7, 13 harmonic emissions, 120 Input / Output Connection, 18 harsh sounds, 7 input connector, 51 heart, 81, 104, 107 input connectors, 34 heart activity, 56, 75 input/output, 121 heart light, 35, 75 insulation, 11 heart rate, 1, 6, 13, 34, 81, 82, 96, 131 interference, 6, 7, 73 heartbeat, 35, 81 Internal error, 113 HF surgical procedures, 10 internal software error, 113 high, 82 internal system error, 15 high heart rate, 60 Internal System Error, 15 High Heart Rate, 14 Intravascular dyes, 9 High SpO2, 14 irradiation, 9 High SpO2 Alarm Light, 20, 86 Isopropyl alcohol, 103 homecare provider, 1, 2, 3, 5, 7, 11, 15, 29, LCD, 113 34, 39, 43, 47, 55, 56, 63, 68, 72, 76, 78, LCD display, 15, 101 80, 91, 93, 96, 98, 105, 109, 111, 112, lead wire, 7, 36, 42, 43, 47, 105 131 lead wires, 5, 7, 11, 48, 64, 75, 106, 108, hospital, 121 111 host phone number, 93 Lead wires, 70 humidification, 8 Lead Wires, 29 hydrogen peroxide, 103 LNOP Neo, 52 immunity, 11 LNOP NeoPt, 52

135 Index

LNOP Pdt, 52 Memory Full, 15, 32, 68 log sheet, 59, 61, 62, 63, 72 memory full light, 93 loose lead, 32 memory transfer device, 99 Loose lead, 14 Met hemoglobin (MetHb), 10 Loose Lead, 70 microwave ovens, 6 loose lead light, 70, 108 modem, 5, 11, 32, 39, 91, 93, 96, 97, 116 Loose Probe, 15 Modem Auto Answer When in lotion, 49 Communications mode, 92 lotions, 4, 65 Modem Auto Answer When Monitoring, 92 Low Battery, 15, 32, 67 Modem Auto Dial, 91 low battery light, 89, 90, 109 modem connector, 94, 97 Low Breath Rate, 14, 80 modem downloads, 97 low heart light, 107 Modem Port, 19 low heart rate, 7, 42, 49, 60, 62, 73, 83 monitor maintenance, 103 Low Heart Rate, 14 monitoring mode, 32 Low SpO2, 14 MRI, 10 Low SpO2 Alarm Light, 88 National Electrical Code (NEC), 55 mains, 121 Nellcor N-200 Pulse Oximeter, 2 manufacturer, 11 Nellcor NPB-295 Pulse Oximeter, 2 Masimo, 52 newborns, 46 Masimo Radical Oximeter, 2 nipples, 44, 73 memory, 36, 39, 91, 111 nitrous oxide, 8 Memory Almost Full, 68 noise, 56 memory card, 91, 99 non-synthetic clothing, 8

136 Index

Normal operation, 66 phone cord, 4, 95, 97, 116 Nova Cosmo ETC02, 2 phone line, 91, 96 Nova Cosmo Oximeter, 2 Phone line, 116 numeric displays, 107 phone number, 93 obstructive apnea, 4 Phone splitter, 116 Ohmeda OXI Pulse Oximeter, 2 physician, 1, 2, 13, 34, 56, 58, 61, 62, 79, oil, 65 80, 83, 86, 87, 91, 131 oils, 4, 49 police, 7 operating humidity, 118, 119 portable use, 39, 89 operating temperature, 118, 119 powder, 49 oximeter patient cable, 34, 50, 65, 72, 106 power, 36, 107 Oximeter Patient Cable, 29 Power, 66, 71 oxygen delivery, 61, 62 POWER button, 71, 75, 76, 96, 97, 100, oxygen tank, 5 102, 108, 113 oxygen-enriched environments, 8 POWER Button, 31 pacemaker, 4 power cord, 8, 53, 55 patient alarm, 56 power light, 75, 76 Patient Alarms, 14 power off procedure, 109, 113 patient cable, 5, 11, 111, 117 Power Off/On Button, 16 Patient cable, 70 power outlet, 53, 89, 109 patient cables, 5, 7, 10, 16, 37, 105, 108 power supply, 3, 5, 36, 39, 53, 54, 66, 89, Percent of SpO2, 20 109, 112, 118, 120, 121 performance, 7 Power Supply, 29 perspiration, 65 Power Supply Connection, 18

137 Index

power supply connector, 54, 90 Self-Test Connector, 37 pressure necrosis, 9 sensor, 59, 85, 117 radio, 7 sensors, 4, 8, 53, 63, 104 Red Apnea, 58 sibling alarm, 71, 76 Red High, 60 side panel, 99, 106 red high light, 35 signal interference, 6 Red High SpO2, 63 signal quality, 11 Red Loose Lead, 64 silence, 111 Red Low SpO2, 60, 62 skin, 65 Red SpO2 Light, 65 skin color, 58 RELEASE button, 102 Skin color, 60, 62, 63 Remote Alarm Connection, 19 skin creams, 4 replacement parts, 11 skin erosion, 9 RESET button, 16, 31, 65, 67, 68, 71, 76, SmartMonitor 2 contents, 29 79, 82, 86, 88, 96, 98, 102, 108, 111, 113 SmartMonitor 2 features respiration, 1, 107 top panel, 31 respiration light, 11, 34, 75, 78 SmartMonitor 2, turning it off, 76 respiration rate, 78 SmartMonitor 2, turning it on, 75 Respironics 930 Oximeter, 2 soap, 104 RF emissions, 120 solvents, 9 RF energy, 120 speaker, 5, 35, 57 rugs, 6 specifications, 9 Sandhill pH Meter, 2 SpO2, 52, 56, 72 Self Adhesive Electrodes, 48 SpO2 probe, 65

138 Index

SpO2 alarms, 52 system check, 75 SpO2 display, 107 system test, 31 SpO2 level, 3, 34, 75, 85, 87 telephone, 3, 93, 97 SpO2 levels, 1, 14, 52 telephone wire, 94 SpO2 light, 35, 75, 85, 107 third (green – RL) electrode, 49, 73 SpO2 probe, 72 transfer data, 91 SpO2 sensor, 9, 34, 106 transmitter signals, 7 static build-up, 6 tripping hazard, 6 static electricity, 6 TV, 6 steam, 9 Type BF Applied Part, 16 storage humidity, 118, 119 Velcro, 44, 45, 73 storage temperature, 118, 119 voltage, 67 strain relief area, 11, 42 voltage dips, 122 strangulation, 5 voltage fluctuations, 120, 122 supplemental oxygen, 62 wall jack, 3, 97, 116 Symbol Reference Card, 29 wall phone jack, 94 Synectics pH Meter, 2 warning, 3, 67 Synthetic fabric, 6 water, 9 system alarm, 66 waterbeds, 6 system alarms, 14 white electrode, 45, 74 System Alarms, 14 white lead wire, 44, 48, 74, 106 system alarms, responding to, 66 wrist strap, 8

139

1015939 [JW 10/20/04]