HeartCheck PEN User manual

Follow these six steps to properly measure and record your heart rhythm.
Step 1 - Preparation
Follow these instructions carefully for each device use. Failure to comply with any
of these instructions will result in an inaccurate measurement.
• Ifyourskinisverydry,useamoisturizer.
• Aer each use, carefully disinfect the contact electrodes only with a
disinfectant swab or equivalent.
Step 2 - Take a Measurement
Hand Measurement
1. Press the POWER button to turn on the device.
2. Sitinacomfortableposition,yourbackstraightandkeepyourngersand
arms in a relaxed position for full duration of the measurement.
3. Ensuretheelectrodesareindirectcontactwithyourskin(ngers)asshown
withyourleandrightindexngersonthetopelectrodes,andyourleand
rightthumbsonthesideelectrodes.
4. PresstheSTARTbuttontobeginameasurement.
5. e device will display a 6 second countdown, and then it will start the
recording.
6. Duringthe30secondrecording,aheartwillashonthescreenandachime
willsoundforeachdetectedheartbeat.Aashingclockiconindicatestime
remainingin therecording.escreenwilldisplayaHR waveformifthe
deviceisunlocked(referto“EnableHeartRhythmDisplay”below).
7. Remainstill,anddonotexormoveyourngersorarmsuntilthe30second
recordingiscomplete.Ifthedevicesensespoorcontactorthemeasurement
isinterruptedbyahandadjustment,youwillneedtorepeattherecording.
Chest Measurement
Ifahandmeasurementisnotideal,usethedeviceto
takeachestmeasurement.Holdthedevicewithyour
righthandandplace theotherelectrodeagainstthe
lesideofyourchestonbareskinabout5cm(2in)
belowthelenipple.
Aerthe measurementis complete,thedevice will displaytheheart rate,anda
ndingof‘StableWaveform’or‘UnexpectedHR’.Tosavethemeasurementinthe
device’smemory,pressthePOWERbutton.
IfyouseeUnexpectedHR,repeatthepreparationandmeasurementstepsabove.
Ifyouhavefollowedall measurementinstructionsinthisguide,andcontinueto
receive“UnexpectedHR”messages,considerconsultingaphysicianoruploading
therecordingthrough GEMSTMHomeforan on-linemedical review. ecause
foranUnexpectedHRmaybeapoorqualityrecordingorthepresenceofafastor
slow heart rate.
CAUTION!
e HeartCheck™ PEN device is not designed for medical diagnosis. Always
consultyourphysicianifyounoticeanychangeinyourhealth,regardlessofthe
measurementresults.If youfeel yourmedical conditionhas changed,consulta
physician even if “Stable Waveform” is displayed as the measurement result,
especiallyifyouhavebeendiagnosedwithapriorheartcondition.
Step 4 - Save the Measurement
Aerameasurementiscomplete,pressthePOWERbuttontosavetherecording.
OncesavedthedisplaywillreturntotheMainMenu.edevicewillsaveupto20
recordings,andwillreplacetheoldestrecordingswiththenewestifmorethan20
records are attempted to be saved.
Step 5 - Review the Measurement Recordings
1. Select“HRRecordings”inthemainmenuscreen,andpressthePOWER
button to enter.
2. ScrollthroughtherecordsusingtheLEFTorRIGHTButton.
3. PressthePOWERbuttontodisplaytheselectedrecordingdata.
Eachrecordingcontainsthefollowinginformation:
erecordingnumber.
Numberofrecordingsonthedevice.
Indicatesastablewaveformrecording.
Measuredheartrate.
(bottomofdisplay)Dateandtimeoftherecording.
Step 6 - Replay your Measurement Recordings *Unlocked devices only*
NOTE: Only unlocked HeartCheckTM PEN devices can replay Heart Rhythm
waveforms (ECGs). If your device is locked, refer to “Enable Heart Rhythm
Display”below.
Ifyourdeviceisunlocked,followthesestepstoreplaytheHeartRhythm,.
1. Selecttherecordingyouwishtoview,andpressthePOWERbutton.
2. e animated replay will pause aer a moment. Scroll through the
remainder of the recording using the RIGHT and LEFT buttons. e
measurementcontains19windows toscrollthrough,andthe topleof
thedisplayshowsthewindowinview(eg:01-02/19istherstwindow).
3. Toexit,pressandholdthePOWERbutton.
4. Toadjustthespeedofthereplay;referto“OtherSettings”.
Smart Monitoring
Pen Device
Powered by CardioComm Solutions, Inc.
The HeartCheck
TM
(8) START:Pressbuttontotakeameasurement.
(9) LethumbElectrode.
(10) LeindexngerElectrode.
(11) Batterycover.
(12) ClothingClip.
Display Screen
edisplayscreenshowsthedateandtime,andbatteryicon.erearevemenus
tonavigatethroughuseoftheLEFTandRIGHTbuttonsasdescribedbelow.
Menu Items
HR Measure: Select this screen, and press the START
buttontostartarecording.
HR Recordings: Select this screen to view recorded
measurements. Use the LEFT and RIGHT buttons to
navigate through recordings. Press POWER to replay
them(unlockeddevicesonly).
Sys Setup: is menu allows you to set date, time, and
othersettings.
Delete Data: is screen allows you to delete recorded
measurements. Use the LEFT and RIGHT buttons to
selectarecording,andthenpressthePOWERbuttonto
delete it.
About: is screen provides device information such as
version and serial number.
about 5cm
CHESTMEASUREMENTFORWOMEN
Position the device at the lower end of the breastbone
andmovehorizontallytothemiddleofthelepart
ofthechest.Ifnecessary,lithebreastandplacethe
leendelectrodeunderthelebreast.
Whencomplete,theresultisdisplayedonthescreen.
Step 3 - View the Measurement Analysis

Heart rate Measurement
LeadPosition:LeadIHandHeld
SamplingRate:250Hz
HeartRateMeasurementRange:30bpm~240bpm
ECGBandwidth:1HZ~40HZ
AccuracyofHeartRateMeasurement: 30bpm~100bpm;±2bpm
    101bpm~240bpm;±4bpm
Display
Type:OLED
Parameters:HeartRate
Environment Requirement
Operationtemperature:5°C~40°C
Storagetemperature:-20°C~55°C
Operationhumidity:≤80%,nocondensation
Storagehumidity:≤93%,nocondensation
Atmosphericpressure:Kpa~106Kpa
Mechanical
Dimension:130×30×20mm
Weight:110g(withalkalinebatteries)
Storage
Dataandheartratestripsstorage
HeartrateStrips:Canstoreupto20measurements
Power Supply
2AAAalkalinebatteries
Classication:
Typeofprotection:Internallypoweredequipment
Degreeofprotection:CFtype
Safety:IEC60601-1
Accessories: Accessories:
Refer to included Packing Slip.
•OneQuickOperationGuide
•OneUserGuide
•OneServicePolicy
•OneCerticateofQuality
•OneUSBCable
•OneInstructionCard
•OnePackingSlip
•TwoAAABattery
Notes:  •Specicationsmaybechangedwithoutpriornotice.
 •Disposalofthisproductandusedbatteriesshouldbecarried
outinaccordancewiththelocalregulationsforthedisposalof
electronic products.
Key Symbols
Symbol Meaning Symbol Meaning
Type CF applied part POWER/returnbutton
ConsultACCOMPANYING
DOCUMENTS.
USBinterface
Heartrate:Unit:bpm(beatper
minute)
Lowbatteryvoltage
SerialNumber European union approval
Manufacturer’sinformation DateofManufacture
Authorizedrepresentativeinthe
European community
IEC 60601-1-2:2007(Ed 2.1) Table 202 Requirements
Guidance and manufacturer‘s declaration – electromagnetic immunity
eequipmentisintendedforuseintheelectromagneticenvironmentspeciedbelow.e
customer or the user of the equipment should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic en-
vironment – guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floors should be
wood,concreteorce-
ramictile.Ifoorsare
covered with synthetic
material,therelative
humidity should be at
least30%.
Electrical fast
transient/burst
IEC61000-4-4
±2kVforpower
supply lines
±1kVforinput/
output lines
N/A Mainpowerquality
should be that of a
typical commercial or
hospital environment.
Surge
IEC61000-4-5
±1kVdierential
mode
±2kVcommon
mode
N/A Mainpowerquality
should be that of a
typical commercial or
hospital environment.
Voltagedips,short
interruptions and
voltagevariationson
power supply input
lines
IEC61000-4-11
<5%UT
(>95%dipinUT)
for0.5cycle
40%UT
(60%dipinUT)
for 5 cycles
70%UT
(30%dipinUT)
for 25 cycles
<5%UT
(>95%dipinUT)
for 5 sec
N/A Mainpowerquality
should be that of a
typical commercial or
hospital environment.
Iftheuserofthe
equipment requires
continued operation
duringpowermains
interruptions,itis
recommended that
the equipment be
powered from an
uninterruptible power
supply or a battery.
Power frequency
(50/60Hz)
magneticeld
IEC61000-4-8
3A/m 3A/m Powerfrequencymag-
neticeldsshouldbe
at levels characteristic
of a typical location in
a typical commercial
or hospital environ-
ment.
NOTE UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
IEC 60601-1-2:2007(Ed 2.1) Table 201 Requirements
1Guidance and manufacturer’s declaration – electromagnetic emission
2eequipmentisintendedforuseintheelectromagneticenvironmentspecied
below. e customer or the user of the equipment should assure that it is used in such
an environment.
3Emissions test Compliance Electromagnetic environment – guidance
4 RF emissions
CISPR11
Group1 eequipmentusesRFenergyonlyfor
itsinternalfunction.erefore,itsRF
emissionsareverylowandarenotlikelyto
cause any interference in nearby electronic
equipment.
5 RF emissions
CISPR11
ClassB
6Harmonicemissions
IEC610000-3-2
N/A
7Voltageuctuation/
ickeremissions
IEC610000-3-3
N/A
IEC 60601-1-2:2007(Ed 2.1) Table 206 Requirements:
Recommended separation distances between portable and mobile RF communications
equipment and the equipment
eequipmentisintendedforuseinanelectromagneticenvironmentinwhichradiated
RF disturbances are controlled. e customer or the user of the equipment can help
preventelectromagneticinterferencebymaintainingaminimumdistancebetween
portableandmobileRFcommunicationsequipment(transmitters)andtheequipmentas
recommendedbelow,accordingtothemaximumoutputpowerofthecommunications
equipment.
Rated maximum
output of
transmitter
W
Separation distance according to frequency of transmitter M
150kHzto80MHz 80MHzto800MHz 800MHzto2.5
GHz
0.01 /0.12 0.23
0.1 / 0.38 0.73
1/1.2 2.3
10 /3.8 7.3
100 / 12 23
For transmitters rated at a maximum output power not listed above the recommended
separationdistancedinmetres(m)canbeestimatedusingtheequationapplicabletothe
frequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetrans-
mitterinwatts(W)accordingtothetransmittermanufacturer.
NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrange
applies.
NOTE2eseguidelinesmaynotapplyinallsituations.Electromagneticpropagationis
aectedbyabsorptionandreectionfromstructures,objectsandpeople.
IEC 60601-1-2:2007(Ed 2.1) Table 204 Requirements
Guidance and manufacturer‘s declaration – electromagnetic immunity
eequipmentisintendedforuseintheelectromagneticenvironmentspeciedbelow.
e customer or the user of the equipment should assure that it is used in such an envi-
ronment.
Immunity test IEC 60601
test level
Compli-
ance level
Electromagnetic environment –
guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3Vrms
150kHzto80
MHz
3V/m80MHzto
2,5GHz
N/A
3V/m
Portable and mobile RF
communications equipment
should be used no closer to any
partoftheequipment,including
cables,thantherecommended
separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation
distance
where pis the maximum output
powerratingofthetransmitter
inwatts(W)accordingtothe
transmitter manufacturer and d
is the recommended separation
distanceinmetres(m).
FieldstrengthsfromxedRF
transmitters,asdeterminedby
anelectromagneticsitesurvey,a
should be less than the compliance
levelineachfrequencyrange.b
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eseguidelinesmaynotapplyinallsituations.Electromagneticisaectedby
absorptionandreectionfromstructures,objectsandpeople.
a Fieldstrengthsfromxed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xedRFtransmitters,anelectromagneticsitesurveyshouldbe
considered.Ifthemeasuredeldstrengthinthelocationinwhichtheequipmentisused
exceedstheapplicableRFcompliancelevelabove,theequipmentshouldbeobservedto
verifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmay
benecessary,suchasreorientingorrelocatingtheequipment.
bOverthefrequencyrange150kHzto80MHz,eldstrengthsshouldbelessthan3V/m.
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