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
Specications..................................................................................................................................................................73
Device Size .........................................................................................................................................................73
Electrical Ratings ................................................................................................................................................73
Environmental Conditions .................................................................................................................................73
IEC Classication...............................................................................................................................................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 eort, 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.
• Beforeusingthemonitor,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 12 hours.
• emonitorwillnotoperatewithouttheinternalbatterypack.Contactyourhomecareproviderifthe
device does not operate properly.
• Placethemonitoronasecureandlevelsurfacetopreventthedevicefromfalling.Donotplacethe
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.
• Ifanemergencyoccursandaccesstothetelephoneisrequiredwhilethemonitorisconnectedtothe
telephonewalljack,unplugthephonecordfromthewalljackandconnectaworkingtelephonetothe
jack.
• Donotusethedeviceinthepresenceofaammableanaestheticmixtureincombinationwithoxygenor
air, or in the presence of nitrous oxide.
• Donotdebrillateachildwhoisattachedtothemonitor.
• Donotuseskincreams,electrodegels,oilsorlotionsunderthesensors.

4 SmartMonitor 2 PS Parents’ Guide
• Themonitormaynotbeabletodetectallepisodesofinadequatebreathing.Ifachildhasapneadueto
choking(obstructiveapnea),themonitorcouldmistakemovementcausedbychokingforbreathing.
• The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.
• AnyoneusingtheSmartMonitor2PSshouldbetrainedincurrentCardiopulmonary Resuscitation (CPR),
which is a proper way to restore breathing and heart activity.
• Donotplacethemonitororexternalpower 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.
• Donotallowthepatient cables, lead wires or power supply cable to become tangled, coiled, crossed, or
wrappedaroundthechild’sneck,arms,orlegs.Thiscouldresultinstrangulation.
• 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.
• Neverusethemonitoronyourchildwhileyourchildisbeingbathed.Thiscouldresultinelectricalshock
to your child.
• DonotconnectthechildtothemonitorifthemonitorisplacedintheCommunications Mode. The apnea
and heart alarmsdonotworkwhenthemonitorisinthismode.
• Donotusethemonitoratthesametimeasotherimpedance monitors. This may cause missed apneas due
to interference.
• Inspectthepower cords and cables often for any signs of damage. Replace a damaged cord or cable
immediately.
• 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 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.

SmartMonitor 2 PS Parents’ Guide 5
• Pinsofconnectorsidentied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, humidication,
conductive oor 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.
•Explosion hazard. Do not use the monitor in the presence of ammable anesthetics or other ammable
substance in combination with air, oxygen-enrichedenvironments,ornitrous oxide.
• 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.
• ismanual,accessory directions for use, all precautionary information, and specicationsshouldberead
before use.
• Donotusedamagedcables.Donotimmersethecablesinwater,solvents,orcleaningsolutions.(e
cables are not waterproof.)
• e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 site at least every two (2) hours with poorly perfused patients.
• IftheSpO2sensor is damaged in any way, discontinue use immediately.
• Topreventdamage,donotsoakorimmersetheSpO2sensorinanyliquidsolution.
• ElevatedlevelsofCarboxyhemoglobin (COHb) or Methemoglobin (MetHb) may lead to inaccurate SpO2
measurements.
• FailuretoapplytheSpO2sensor properly may cause incorrect measurements.
• Donottouchthemonitorandthechildsimultaneously.
• Donotrockthechildorsleepinthesamebedwiththechildwhilemonitoring.Touchingormovingnear
the child, monitor or cables could cause the monitor to miss apneas.

6 SmartMonitor 2 PS Parents’ Guide
cautions
A caution indicates the possibility of damage to the device.
• Performthefunctionalself-testifthemonitorhasbeenx-rayedbyanairportsecuritycheck.
• Disconnectthepowersupplyduringlightningstormstoreduceriskofelectricalshocktoyourequipment.
e SmartMonitor 2 PS will not download by modem when the power supply and phone line are
disconnected.
• Ifyourchildisbreathingquietlyandtherespiration light ashes more or fewer times than your child
breathes, contact your home care provider for service.
• Donotsendinformationviamodemduringelectricalstorms.Informationcouldbelostorequipment
could be damaged.
• 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.
• Anyforeign matter that gets into the enclosure of the monitor may cause malfunction.
• euseofaccessoriesotherthanthosespecied,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.
• Ifyounoticeanyunexplainedchangesintheperformanceofthisdevice,ifitismakingunusualorharsh
sounds, if the device is dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is
broken,discontinueuseandcontactyourhomecareprovider.
• Checkthemonitor’srespirationlight.Listenwhilethechildbreathes,andwatchtherespirationdetection
lightonthemonitor.Whilethechildisbreathingquietly,thelightshouldashonceandonlyoncefor
eachbreaththechildtakes.Howeverthelightmayashadditionaltimeswhenthechildismoving.Ifthe
childisbreathingquietlyandtherespirationlightashesmoreorfewertimesthanyourchildbreathes,
stop using the device and contact your home care provider.

SmartMonitor 2 PS Parents’ Guide 7
hoW does the monitor Work?
Your child’s breathing is measured simply by placing two electrodes on the sides of the child’s chest under his or
her arms. As the child’s chest moves, during breathing, the impedance between the electrodes will change. e
monitor detects these changes for determining the child’s breathing eort. If the monitor does not detect these
changes in breathing eort, a light will come on and an alarm will sound. e monitor also uses the electrodes
onthechesttomonitorheartactivitybypickinguptheelectricalchangesproducedbytheheart.Ifthemonitor
detects the heart rate outside the range ordered by the physician, a light will come on and an alarm will sound.
e device also monitors blood oxygen levels (SpO2)throughasensorattachedtothechild’stoeornger.Ifthe
monitor detects SpO2values outside the range ordered by the physician, a light will come on and/or an alarm
will sound.
hoW the alarms oPerate
Whenever your child’s breathing eort, heart activity and SpO2levels are not within the limits set by your
physician,anindicatorlightwillcomeonandanalarmwillsound.emonitorhastwotypesofalarms:
patient and system.
PatientAlarms:Abeepingalarmindicatesoneofthefollowingpatientalarmevents:
• Apnea:Child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lowerthanthelimitsetbyyourphysician.
• HighHeartRate:HeartRateishigherthanthelimitsetbyyourphysician.
• LowSpO2:SpO2level is lower than the limit set by your physician.
•High SpO2:SpO2level is higher than the limit set by your physician.

8 SmartMonitor 2 PS Parents’ Guide
SystemAlarms:Aconstantaudiblealarmindicatesoneofthefollowingmonitorconditions:
• Looselead(forbreathingandheartactivity)
•Probe O (for SpO2)
• LowBattery(orVeryLowBattery)
•Memory Full (or Memory Almost Full)
• AccidentalPower-O
•Internal System Error
Lightsonthemonitorindicatewhichoftheseconditionsexists.Seethesections“MonitoringYourChild,”
“RespondingtoPatientAlarms,”and“RespondingtoSystemAlarms”formoreinformationaboutalarms.
CAUTION: The monitor 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 o, 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 home
care provider.

SmartMonitor 2 PS Parents’ Guide 9
symbols
symbol definition
Attention: Read accompanying documents.
0086
European Declaration of Conformity
Separate collection for electrical and electronic equipment per EC Directive 2002/96/EC
European Representative
Type BF Applied Part (also shows Patient Cable Connector location)
RESET Button
POWER O/On Button
Apnea Alarm Light

10 SmartMonitor 2 PS Parents’ Guide
symbol definition
Respiration Light
Low Heart Rate Alarm Light
High Heart Rate Alarm Light
Low Battery Light
Memory Full Light
Loose Lead Light
Heart Rate Light
Power Light
Charger Light
Power Supply Connection
Input/Output Connection
Modem Port

SmartMonitor 2 PS Parents’ Guide 11
symbol definition
Nurse Call Connection (for institutional use only)
SN Serial Number
BPM Beats Per Minute
BrPM Breaths Per Minute
Percent of SpO2
High SpO2Alarm Light
Low SpO2Alarm Light
ESD Warning Symbol
Connector Position
IPX1 Drip Proof Equipment
Class II (Double Insulated)
SpO2Oxygen Saturation

12 SmartMonitor 2 PS Parents’ Guide
fcc Part 68 telecom information
registration number and ren
is monitor’s modem complies with Part 68 of the Federal Communication Commission (FCC) rules. On the
bottom of the monitor 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.eFCCregistrationnumberis:CMVMM05B4000-20.
usoc Jack
emonitor’smodemisdesignedtobeusedonstandarddevicetelephonelines.esuitableUSOCjack
(Universal Service Order Code connecting arrangement) for this modem is RJ11C or RJ11W (single line).
comPliant accessories
etelephonecordandmodularplugprovidedwiththisequipmentarecompliantwithapplicableFederal
CommunicationCommission(FCC)rules.is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.

SmartMonitor 2 PS Parents’ Guide 13
number of rens
e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notringinginresponseto
anincomingcall.Inmostbutnotallareas,thesumofRENsshouldnotexceedve(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 SmartMonitor 2 PS or SmartMonitor 2 PSL 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 le a
complaint with the Federal Communications Commission (FCC) if you believe ling a complaint is necessary.
changes in service
etelephonecompanymaymakechangesinitsfacilities,equipment,operations,orproceduresthatcould
aecttheoperationofthisequipment.Ifthishappens,thetelephonecompanywillprovideadvancenoticein
orderforyoutomakenecessarymodicationstomaintainuninterruptedservice.
Problems
IftroubleisexperiencedwiththisSmartMonitor2PSorSmartMonitor2PSLmodem,pleasecontact
yourhomecareproviderorCircadianceat1-888-825-9640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.

14 SmartMonitor 2 PS Parents’ Guide
rePairs
Norepairsaretobemadebyyou.Wheneveratechnicalproblemoccursthatyoucannothandle,contactyour
home care provider. Unauthorized repairs void registration and warranty.
Party lines
Connection to party line service is subject to state taris. 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 that the installation of
the monitor’s modem does not disable your alarm equipment. If you have questions about what will disable alarm
equipment, consult your telephone company or a qualied installer.
industry canada requirements
ic abbreviation
isequipmentmeetstheapplicableIndustryCanadaTerminalEquipmentTechnicalSpecications.is
isconrmedbytheregistrationnumber.eabbreviation,IC,beforetheregistrationnumbersigniesthat
registration was performed based on a Declaration of Conformity indicating that Industry Canada technical
specicationsweremet.ItdoesnotimplythatIndustryCanadaapprovedtheequipment.eICnumberis:
9141A-400020.