Circadiance SmartMonitor 2 PS Assembly Instructions

SmartMonitor 2 PS
Parents’ Guide

© 2015Circadiance, LLC., All rights reserved.

SmartMonitor 2 PS Parents’ Guide iii
Table of ConTenTs
What is the Purpose of the SmartMonitor 2 PS?...............................................................................................................1
Introduction.....................................................................................................................................................................2
About is Manual...............................................................................................................................................2
Indications for Use................................................................................................................................................2
Warnings and Cautions....................................................................................................................................................3
Warnings ..............................................................................................................................................................3
Cautions...............................................................................................................................................................6
How Does e Monitor Work? ........................................................................................................................................7
How the Alarms Operate ......................................................................................................................................7
Symbols...............................................................................................................................................................9
FCC Part 68 Telecom Information .....................................................................................................................12
Registration Number and REN ..........................................................................................................................12
USOC Jack ................................................................................................................................................12
Compliant Accessories................................................................................................................................12
Number of RENs.......................................................................................................................................13
Changes in Service .....................................................................................................................................13
Problems ....................................................................................................................................................13
Repairs.......................................................................................................................................................14
Party Lines .................................................................................................................................................14
Industry Canada Requirements...........................................................................................................................14
IC Abbreviation .........................................................................................................................................14

iv SmartMonitor 2 PS Parents’ Guide
REN ..........................................................................................................................................................15
Industry Canada CS-03 Notice .................................................................................................................15
FCC Part 15 .............................................................................................................................................16
Getting to Know the Monitor ........................................................................................................................................17
SmartMonitor 2 PS Features...............................................................................................................................19
Top Panel Features..............................................................................................................................................19
POWER Button ........................................................................................................................................19
RESET Button...........................................................................................................................................20
Front Panel Features ...........................................................................................................................................21
Display of Values.......................................................................................................................................21
Respiration Lights ......................................................................................................................................22
Heart Lights...............................................................................................................................................22
SpO2 Lights...............................................................................................................................................22
Speaker ......................................................................................................................................................22
System Lights.............................................................................................................................................23
Side Panel Features..............................................................................................................................................24
Self-Test Connector...................................................................................................................................24
Back Panel Features.............................................................................................................................................25
Nurse Call (Institutional/Hospital Use Only).............................................................................................25
Modem (Optional) ....................................................................................................................................25
I/O Connector...........................................................................................................................................26
DC Power ..................................................................................................................................................26
Stand..........................................................................................................................................................26

SmartMonitor 2 PS Parents’ Guide v
Respiration, Heart, and SpO2 Monitoring .....................................................................................................................27
Disposable Self Adhesive Electrodes....................................................................................................................32
Responding to Alarms...................................................................................................................................................37
Patient Alarms ....................................................................................................................................................37
Testing the Alarm ...............................................................................................................................................37
System Alarms ....................................................................................................................................................40
Reducing False Alarms........................................................................................................................................43
Monitoring Your Child ..................................................................................................................................................45
Turning the Monitor On ....................................................................................................................................45
Turning the Monitor O - Sibling Alarm ...........................................................................................................46
Monitoring Your Child’s Breathing.....................................................................................................................47
Respiration Light .......................................................................................................................................47
Apnea Alarm Light.....................................................................................................................................48
Monitoring Your Child’s Heart Activity ..............................................................................................................49
Heart Rate Light/Display...........................................................................................................................49
High Heart Rate Alarm Light.....................................................................................................................50
Low Heart Rate Alarm Light......................................................................................................................51
Monitoring Your Child’s Oxygen Saturation Level..............................................................................................52
SpO2 Light/Display...................................................................................................................................52
High SpO2 Alarm Light ............................................................................................................................53
Low SpO2 Alarm Light..............................................................................................................................54
Portable Operation of the Monitor.................................................................................................................................55
Charging the Monitor.........................................................................................................................................55

vi SmartMonitor 2 PS Parents’ Guide
Transferring the Monitor’s Information ..........................................................................................................................57
Modem Download .............................................................................................................................................57
Modem Auto Dial......................................................................................................................................58
Modem Auto Answer in Communications Mode.......................................................................................60
Modem Auto Answer in Monitor Mode.....................................................................................................61
Transferring the Monitor’s Data to a Memory Card............................................................................................62
Caring for Your Monitor ................................................................................................................................................65
Cleaning Instructions..........................................................................................................................................65
Performing a Functional Self-Test .......................................................................................................................66
Self-Test Troubleshooting ...........................................................................................................................68
Troubleshooting .............................................................................................................................................................69
Specications..................................................................................................................................................................73
Device Size .........................................................................................................................................................73
Electrical Ratings ................................................................................................................................................73
Environmental Conditions .................................................................................................................................73
IEC Classication...............................................................................................................................................74
Disposal..............................................................................................................................................................74
EMC Requirements .......................................................................................................................................................75
Glossary .........................................................................................................................................................................79
SmartMonitor 2 Clinical Summary ................................................................................................................................81

SmartMonitor 2 PS Parents’ Guide 1
What is the PurPose of the smartmonitor 2 Ps?
e SmartMonitor 2 PS is designed to monitor and record breathing (respiration) heart (cardiac) activity and
SpO2levels (functional oxygen saturation). e monitor alerts you if any of these activities exceeds the limits
prescribed by your physician.
Patient alarm limits are set by your home care provider before you receive your monitor. During your
child’s monitoring, when your child’s breathing eort, heart activity and SpO2levels are not within these set
boundaries, an indicator light comes on and an alarm sounds. is manual explains how to set up the monitor,
how to monitor your child, and how to transfer the information. Other auxiliary devices may also be used with
the monitor. If your physician prescribes any of auxiliary devices, your home care provider can discuss them
with you.

2 SmartMonitor 2 PS Parents’ Guide
introduction
about this manual
This manual provides all the information you need to set up and operate the Circadiance SmartMonitor 2 PS
and explains how to use it to monitor your child. Carefully read and understand this manual before using the
system.
indications for use
e SmartMonitor 2 PS is intended for use in the continuous monitoring of respiration, heart rate, and SpO2
levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or
low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or
hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or
adult monitor, it is intended for use in a hospital environment.

SmartMonitor 2 PS Parents’ Guide 3
Warnings and cautions
Please read this section carefully before using the SmartMonitor 2 PS.
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician.
Warnings
A warning indicates the possibility of injury to the user or operator.
• Beforeusingthemonitor,chargetheinternalbatterypack.Connectthepowersupplytothedevice,and
ensure that it is plugged into a functional AC wall outlet for a minimum of 12 hours.
• emonitorwillnotoperatewithouttheinternalbatterypack.Contactyourhomecareproviderifthe
device does not operate properly.
• Placethemonitoronasecureandlevelsurfacetopreventthedevicefromfalling.Donotplacethe
monitor on the oor 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.
• Ifanemergencyoccursandaccesstothetelephoneisrequiredwhilethemonitorisconnectedtothe
telephonewalljack,unplugthephonecordfromthewalljackandconnectaworkingtelephonetothe
jack.
• Donotusethedeviceinthepresenceofaammableanaestheticmixtureincombinationwithoxygenor
air, or in the presence of nitrous oxide.
• Donotdebrillateachildwhoisattachedtothemonitor.
• Donotuseskincreams,electrodegels,oilsorlotionsunderthesensors.

4 SmartMonitor 2 PS Parents’ Guide
• Themonitormaynotbeabletodetectallepisodesofinadequatebreathing.Ifachildhasapneadueto
choking(obstructiveapnea),themonitorcouldmistakemovementcausedbychokingforbreathing.
• TheSmartMonitor2PSisamonitoringdeviceonly.Itdoesnotpreventthelossofbreathingorheart
activity, nor will it restore breathing or heart activity. It will not prevent death.
• AnyoneusingtheSmartMonitor2PSshouldbetrainedincurrentCardiopulmonary Resuscitation (CPR),
which is a proper way to restore breathing and heart activity.
• Donotplacethemonitororexternalpower supply in any position that might cause it to fall on the child.
Do not lift the monitor by the power supply cord or patient cable; use only the handle on the monitor.
• Donotallowthepatient cables, lead wires or power supply cable to become tangled, coiled, crossed, or
wrappedaroundthechild’sneck,arms,orlegs.Thiscouldresultinstrangulation.
• Donotblockthespeakerorplaceitemsinfrontofthespeakerlocatedonthefrontofthedevice.This
could prevent the monitor alarm from being heard.
• Neverusethemonitoronyourchildwhileyourchildisbeingbathed.Thiscouldresultinelectricalshock
to your child.
• DonotconnectthechildtothemonitorifthemonitorisplacedintheCommunications Mode. The apnea
and heart alarmsdonotworkwhenthemonitorisinthismode.
• Donotusethemonitoratthesametimeasotherimpedance monitors. This may cause missed apneas due
to interference.
• Inspectthepower cords and cables often for any signs of damage. Replace a damaged cord or cable
immediately.
• Donotusenon-safetystyleleadwiresandpatientcableconfigurationswiththismonitor.Theirusemay
poseariskofsevereelectricalshockordeath.Refertotheinstructionsinthismanualtoensureproper
connections. Use only Circadiance recommended safety lead wires, patient cables, electrodes and sensors.
•The monitor should be placed in an area out of reach of the patient to minimize the risk of small parts
being inhaled or swallowed and the risk of fingers or flesh being entrapped in the device.
•The monitor shall only be used on one patient at a time.
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