Blood Pressure Monitor
Instruction Manuel Model: 106-930
Multi-User: 2 x 60 Readings
Irregular Heartbeat Indicator
Hypertension Risk Indicator
Date and Time Indicator
CONTENTS ESSENTIA+ INTRODUCTION ........................................................................ 2
IMPORTANT INFORMATION ...................................................................... 2• White Coat Syndrome
ABOUT BLOOD PRESSURE ......................................................................... 5• Blood Pressure Standard• BloodPressureClassificationIndicator• WhatisSystolicandDiastolicPressure?• BloodPressureFluctuation
YOUR BP MONITOR .................................................................................... 8• LCDLayout• Unit Layout
POWER OPTIONS ....................................................................................... 10
GETTING STARTED .................................................................................... 11• SelectingMemoryZoneandSettingDate, Time,andUnitofMeasurement
MEASUREMENT ........................................................................................ 13
USING THE MEMORY ................................................................................ 18• RecallingtheRecords• DeletingAllRecords
TIPS FOR TAKING ACCURATE READINGS ............................................... 20
MAINTENANCE.......................................................................................... 21
TROUBLESHOOTING ................................................................................. 22
SPECIFICATIONS ........................................................................................ 24
LIFETIME LIMITED WARRANTY ............................................................... 30
2
EssentiA+ Instruction Manual
ThankyouforpurchasingtheEssentia+BloodPressureMonitor. Byselectingthisproduct,youhavechosenahighquality,innovativedevice.BeforeusingtheEssentia+BloodPressureMonitorforthefirsttime,pleasereadthroughthismanualcarefully.Ifyoustillhaveanyquestionsregardingitsuse,visitthePhysioLogicwebsiteat www.amgphysiologic.comorcontactourCustomerServiceteam at1-800-363-2381.
IMPORTANT INFORMATION
ReadingstakenbythePhysioLogic®EssentiA+areequivalent tothoseobtainedbyatrainedhealthcareprofessionalusingthe cuffandstethoscopeauscultationmethod.Thismanualcontains importantsafetyandcareinformation,andprovidesstepbystep instructionsforusingtheproduct.Readthismanualthoroughly beforeusingthedevice.
Yourphysician’sreadingmaysometimesdifferfromyourhome readings.Thiscouldberelatedtoaphenomenonknownas “whitecoatsyndrome”.You should not assume that any single reading taken is your usual blood pressure.
Infact,blood pressure varies constantly throughout the day. Commonactivitiesaffectyourlevelofheartactivityandstress, therebyinfluencingyourbloodpressure.
Note: Thisproductisdesignedforhomebloodpressuremonitoringanddoesnotrequiretheassistanceofahealthcareprofessional.
Thedeviceisintendedforusagebyoneperson.Itisimportantthatyoutakehomereadingsregularly,andthatyoufollowtheproceduresandprecautionsmentionedintheinstructionmanual.Consistentlyrecord-ing/chartingyourreadings,alongwithregularlyconsultingahealthprofessional,isanimportantaspectofyouroverallbloodpressuremanagementprogram.
EssentiA+ Instruction Manual
3
IMPORTANT INFORMATION
ATTENTION• ThisBloodPressureMonitordoesnotreplaceexaminationbyaphysician. Yourdoctoristheonepersonbestqualifiedtointerpretyourresults, werecommendthatyoukeepabloodpressurejournaltobringtoyour visitswithyourhealthcareprofessional.
• Thisdeviceisintendedforadultathomeuseonly.
• Thisdeviceisintendedfornon-invasivemeasuringandmonitoringofarterialbloodpressure.Itisnotintendedforuseonextremitiesotherthanthearmorforfunctionsotherthanobtainingabloodpressuremeasurement.
• Donotconfuseself-monitoringwithself-diagnosis.Thisunitallowsyoutomonitoryourbloodpressure.Donotbeginorendmedicaltreatmentbasedsolelyonreadingsobtainedfromthisdevice.Asthepatientistheintendedoperator,alwaysconsultaphysicianbeforestartinganytreatment.
• Ifyouaretakingmedication,consultyourphysiciantodeterminethemostappropriatetimetomeasureyourbloodpressure.Neverchangeaprescribedmedicationwithoutconsultingyourdoctor.
• Individualswithseriouscirculationproblemsmayexperiencediscomfort. Consultyourphysicianpriortouse.
• Peoplewithvascularconstriction,liverdisordersordiabetes,peoplewith cardiacpacemakersoraweakpulse,andwomenwhoarepregnantshould consulttheirphysicianbeforemeasuringtheirbloodpressurethemselves.
• Thecuffshouldnotbeappliedoverawoundasthiscancausefurtherinjury.
• DONOTattachthecufftoalimbbeingusedforIVinfusionsoranyother intravascularaccess,therapyoranarterio-venous(A-V)shunt. Thecuffinflationcantemporarilyblockbloodflow,potentiallycausingharm.
• Thecuffshouldnotbeplacedonthearmsamesideofamastectomy. Inthecaseofadoublemastectomy,usethesideoftheleastdominantarm.
• Ifthecuffpressureexceeds37.24kPa(280mmHg),theunitwillautomaticallydeflate.Shouldthecuffnotdeflatewhenpressureexceeds37.24kPa (280mmHg),detachthecufffromthearmandpressthe(START/STOP) buttontostopinflation.
• Donotdisassemble,attempttorepair,orperformanymaintenance totheunitwhilethedeviceisinuse.
• Donotdroptheunit.Protectitfromsuddenshock.
• Donotinsertforeignobjectsintoanyopenings.
4
EssentiA+ Instruction Manual
ATTENTION• Donotcrushthecuff.
• Iftheunithasbeenstoredattemperaturesbelow0oC,leaveitatroom temperatureforabout2hoursbeforeusingit.Otherwise,thecuffmay notinflateproperly.
• Iftheunithasbeenstoredattemperaturesabove40oC,leaveitatroom temperatureforabout2hoursbeforeusingit.Otherwise,thecuffmay notinflateproperly.
• Replacingthecuffwithanalternatemodelmayresultinmeasurementerror.
• Donotsubjectthemonitortoextremehotorcoldtemperatures,humidityordirectsunlight.Donotstoretheunitindirectsunlight,highhumidityordust.
• Productisdesignedforitsintendeduseonly.Donotmisuseinanyway.
• Productisnotintendedforchildrenorpersonswithspecialneeds.
• Toavoidanypossibilityofaccidentalstrangulation,keepthisunitaway fromchildrenanddonotdrapetubingaroundyourneck.
• Keepproductoutofreachofchildren.Somepartsaresmallandmay representachokinghazard.
• Prolongedover-inflationofthebladdermaycauseecchymomaofyourarm.
• OnlyuseA.M.GMedicalInc.authorizedpartsandaccessories.Partsand accessoriesnotapprovedforusewiththedevicemaydamagetheunit. Retrofittingthedevicewillvoidthewarranty.
• Somemaygetaskinirritationfromthecufftakingfrequentreadingsover thecourseoftheday,butthisirritationtypicallygoesawayonitsownafter themonitorisremoved.
• Thesystemmightproduceincorrectreadingsifstoredorusedoutside themanufacturer’sspecifiedtemperatureandhumidityranges.
• Removebatteriesfromdevicewhennotinoperationformorethan3months.
• Disposebatteriesproperly;observelocallawsandregulations.
• ThePCwithconnectiontothedevicewithUSBshallmeettherequirements ofstandardIEC60601-1orIEC60950-1.
IMPORTANT INFORMATION
EssentiA+ Instruction Manual
5
ABOUT BLOOD PRESSURE
Blood Pressure Standard TheJointNationalCommitteeonprevention,detection,evaluation, andtreatmentofhighbloodpressurehasdevelopedablood pressurestandard,accordingtowhichareasoflowandhighrisk bloodpressureareidentified.Thisstandardisaguidelineasblood pressurevariesamongdifferentpeopleanddifferentagegroups. Itisimportantthatyouconsultwithyourphysicianregularly. Yourphysicianwilltellyouyournormalbloodpressurerange, aswellasthepointatwhichyouwillbeconsideredatrisk.
Blood Pressure for Adults Age 18 and Older
Category Systolic (mmHg) Diastolic (mmHg)Stage 2 Hypertension > 160 or > 100
Stage 1 Hypertension 140-159 or 90-99
Prehypertension 120-139 or 80-89
Normal < 120 and < 80
ATTENTION• Donotusethedevicenearstrongelectricalorelectromagneticfields generatedbycellphonesorotherdevices,theymaycauseincorrectreadingsandinterferenceorbecomeinterferencesourcetothedevice.Donotusethedeviceduringtransportoutsidehealthcarefacilityforinterferencesourceexistingaswell.
• ToassurethecorrectuseoftheEssentia+BPmonitor,basicsafetymeasuresshouldalwaysbefollowedincludingthewarningandprecautionslistedin thisbooklet.Carefully read this manual before using the product.
IMPORTANT INFORMATION
6
EssentiA+ Instruction Manual
ABOUT BLOOD PRESSURE
What is systolic and diastolic pressure?
Whenventriclescontractandpumpbloodoutoftheheart,blood pressurereachesitsmaximumvalue.Thehighestpressureinthecycleisknownas systolic pressure. Whentheheartrelaxesbetween heartbeats,thelowestblood pressureisdiastolic pressure.
Blood Pressure Fluctuation Bloodpressurefluctuatesallthetime.Youshouldnotbeoverly worriedifyouencountertwoorthreemeasurementsathighlevels. Bloodpressurechangesthroughouttheday.
artery
press
veinblood discharging
Systolic
relax
blood enteringDiastolic
(Case: Male, 35 years old)
Wakeup
ArriveOffice Office
Leave Dinner/ Sleep
TelephoneDiscussion
Argumentin a Meeting
18:00 Midnight12:006:00
50
100
150 mmHg
Systolic
Diastolic
Blood Pressure Classification Indicator (WHO)
Yourmonitorincludesaclassificationindicatorbasedonestablished guidelinesfromtheWorldHealthOrganization(WHO).Thechart below(colourcodedonunit) indicatestestresults.
Severe Hypertension (Red)
Mild Hypertension (Yellow)
High-Normal (Green)
Optimal (Green)
Moderate Hypertension (Orange)
Normal (Green)
EssentiA+ Instruction Manual
7
MEASUREMENT TIPS
ImportantNotesHere are a few helpful tips to help you obtain more accurate readings:
• Bloodpressurechangeswitheveryheartbeatandisinconstant fluctuationthroughouttheday.
• Bloodpressurerecordingcanbeaffectedbythepositionoftheuser,hisorherphysiologicalconditionandotherfactors.Forgreatestaccuracy,avoidexercising,bathing,eating,drinkingbeverageswithalcohol orcaffeine,orsmokingonehourpriortomeasuringbloodpressure.
• Beforemeasurement,it’ssuggestedthatyousitquietlyfor15minutesasmeasurementtakenduringarelaxedstatewillhavegreateraccuracy.Youshouldnotbephysicallytiredorexhaustedwhentakingameasurement.
• Donottakemeasurementsifyouareunderstressortension.
• Duringmeasurement,donottalkormoveyourarmorhandmuscles.
• Takeyourbloodpressureatnormalbodytemperature.Ifyouarefeelingcoldorhot,waitawhilebeforetakingameasurement.
• Ifthemonitorisstoredatverylowtemperature(nearfreezing), haveitplacedatawarmlocationforatleasttwohoursbeforeusingit.
• Waitabout5minutesbeforetakingthenextmeasurement.
8
EssentiA+ Instruction Manual
YOUR BP MONITIOR
LCD
Memory ZoneSystolicBlood Pressure
DiastolicBlood Pressure
Pulse Rate
Memory Number Indicator
Low Battery Indicator
Cuff Is Inflating
Last 3 Results Average
Irregular Heartbeat Indicator
Time
Date
Cuff Is Deflating
WHO Blood Pressure Classification Indicator
mmHg kPa
M D No
AVG (( ))
INDEX
Arm Cuff Air PlugAir Tube
Arm Cuff
Instruction Manual
Blood Pressure Monitor
Instruction Manuel Model: 106-930
Multi-User: 2 x 60 Reading
Irregular Heartbeat Indicator
Hypertension Risk Indicator
Date and Time Indicator
EssentiA+ Instruction Manual
9
YOUR MONITOR
Air JackLCD Screen
SET Button
START / STOP Button
M Button
Pulse Rate
Diastolic Blood Pressure
Systolic Blood Pressure
Blood Pressure Classification Indicator
Battery Cover
Unit Layout
Storage Case
10
EssentiA+ Instruction Manual
POWER OPTIONS
• Battery:4xAAalkalinebatteries
• USBPowerSource (Cablenotincluded)
USB Power Source
Installing and Replacing Batteries
1. Slideoffthebatterycover.
2. Installthebatteriesbymatching thecorrectpolarity,asshown.
3. Closethecover.
Low Battery Indicator
4shortwarningbeepssoundwhenbatterylifeisdepletingand unabletoinflatecufffortesting.The appearssimultaneously forapproximately5secondspriortoshuttingoff.Replacebatteries atthistime.Nomemorylosswilloccurthroughoutthisprocess.
CAUTION
CAUTION
Donotuseanyothertypeofbattery asitmayharmtheunit.
Replacethebatteriesifanyofthefollowingshouldoccur:
• The indicatorappears•Thedisplayappearsdim•Thedisplaydoesnotlightup
Note: Removethebatteriesiftheunitwillnotbeusedforan extendedperiodoftime.Alwaysreplaceallthebatterieswith newonesatthesametime.
EssentiA+ Instruction Manual
11
STARTSTOPSET M
STARTSTOPSET M
STARTSTOPSET M
1 2
STARTSTOPSET M
STARTSTOPSET M
STARTSTOPSET M
1 2
GETTING STARTED
Selecting Memory Zone and Setting Date, Time, and Unit of Measurement
Itisimportanttosetthetimebeforeusingyourbloodpressure monitor,sothatatimestampcanbeassignedtoeachreading thatisstoredinthememory.
1.Withpoweroff, press“SET”buttontoactivatesystemsettingsmode.TheMemoryGroupiconflashes.
2.Press“M“buttontochooseagroupsetting.Testresultswill automaticallybestoredintheselectedgroup.There are 2 zones, each zone can store up to 60 readings.
12
EssentiA+ Instruction Manual
GETTING STARTED
3. Afterselectingyourmemoryzone, pressSETtoautomaticallymove tothenextstep.
4. Setthemonthfirstbypressingthe“M“button.ThenPressthe“SET”button toconfirm.Continuewiththesamestep fortheday,hour,andminute.Everytimethe“SET”buttonispressed,itwilllockyourselection.
5. Aftertheunitisset,pressthe powerbuttontoturnofftheunit andsaveallcurrentsettings.
STARTSTOPSET M
STARTSTOPSET M
M D
STARTSTOPSET M
EssentiA+ Instruction Manual
13
MEASUREMENT
Prepare the Cuff
1. Firmlyinsertairplugintoopening locatedonleftsideofthemonitor.
2.Wrapthecuffaroundyourupper leftarm.Thetubeshouldbealignedtopointtowardyourlittlefinger, asillustrated.
14
EssentiA+ Instruction Manual
MEASUREMENT
Prepare the Cuff
3. Thecuffshouldbesnug,butnottootight.(Youshouldbeable toinsertonefingerbetweenthecuffandyourarm).Keepaspaceof1-2cm(0.4”-0.8”)betweenthecuffedgeandyourelbow.
4. Sitcomfortablywithyourleftarmrestingonaflatsurface andthecuffatheartlevel.
1 - 2 cm (0.4”- 0.8”)
ON/OFF
CAUTIONIfthepressureinthearmcuffbecomestoopowerfulwhiletesting, presstheSTART/STOPbuttontoturnpoweroff.Thecuffwillrapidly deflateoncetheunitisturnedoff.
EssentiA+ Instruction Manual
15
MEASUREMENT
Start the Measurement
1. PressandholdtheSTART/STOPbuttonuntilabeepsounds.TheLCDscreenwilllightupfollowedbyalongtonewhichindicatesthedeviceisreadyfortesting.
2. Initialpressureisfirstpumpedto190mmHg.Theunitwillautomaticallyadjusttooneoffourpressurelevelsbasedonthecurrentuser’sbloodpressure.
Levels: 190mmHg 220mmHg 250mmHg 280mmHg
mmHg kPa
M D No
AVG (( ))
mmHg
M D
16
EssentiA+ Instruction Manual
MEASUREMENT
NOTE•Itisrecommendedtowaitatleast5minutes betweenmeasurementsforaccurateresults.
•IfunitisleftONandnotinusefor3minutes, itwillautomaticallysaveallinformationand shutoff.
Start the Measurement
3. Onceinflated,thecuffwillslowly deflateandmeasureyourblood pressure.Aflashing“ “will appearsimultaneouslyonscreen signalingheartbeatdetection.
4.Whentestingiscompletethemonitorwillsoundthreeshortbeeps.Thescreenwilldisplayyoursystolicanddiastolicbloodpressure.Thereadingwillbeautomaticallystoredintheselectedmemoryzone.
5. Totakeanotherreadingpressthe “START/STOP“buttontwice.
mmHg kPa
M D No
AVG (( ))
mmHg
M D
STARTSTOPSET M
EssentiA+ Instruction Manual
17
MEASUREMENT
Test Average
Withpoweroff,pressthe“M“button toactivatescreendisplay.Aftertheunit performsaselfdiagnosis,thescreenwill displaytheaveragetestresultsfromthe last3readingsofthelastmemoryzoneused. The“AVG“symbolwillappearalongwith thecorrespondingBloodPressureIndicator.Pressthe”M”buttonagain,andthescreen willdisplaytheaverageofthelastseven daystestresultsfrom5:00am–8:59am. Pressthe”M”buttonagain,andthescreen willdisplaytheaverageofthelastseven daystestresultsforeveningreadings between18:00pm–19:59pm.
Tochecktheaverageresultsfromanothermemorygroup,selectthedesiredgroup firstpriortoactivatingthe“M“buttonin theoffposition.(SeeSelectMemoryGrouponpage11)
Irregular Heartbeat Indicator
Ifthemonitordetectsanirregularheartrhythmtwoormoretimesduringthemeasuringprocess,theIrregularHeartbeatSymbol“ “ appearsonscreenalongwithmeasurementresults.Irregular heartbeatrhythmisdefinedasrhythmthatiseither25%slower orfasterthantheaveragerhythmdetectedwhilemeasuringsystolicanddiastolicbloodpressure.ConsultyourphysicianiftheIrregular HeartbeatSymbol“ “appearsfrequentlywithyourtestresults.
mmHg
M D
AVG
18
EssentiA+ Instruction Manual
USING THE MEMORY
Memory Check
Youmaycheckpasttestresultsbyusingthe“M“button.Themostrecentandoldesttestresultinmemorycanbeviewedbypressingandholdingthe“M“button.Uponactivatingtestresultsyoucanpressthe“M”buttontoscrollthroughalltestresultsstoredinmemory.
Ifthenumberoftestssurpassestheallotted60memoriespergroup,themostrecenttestswillappearfirst,thuseliminatingtheoldestread-ings.
mmHg
M DM D No
NOTEPastreadingswillonlybedisplayedfromthemostrecentlyusedmemoryzone.Tocheckpasttestresultsinanothermemoryzone,youmustfirstselectthe desiredzoneandthenturnmonitoroff.(See“SelectMemoryZone”onpage11)
EssentiA+ Instruction Manual
19
USING THE MEMORY
CAUTIONReadingscannotberecoveredoncedeleted.
To Delete All Records From Memory
Youcanclearthememoryfortheselectedgroupwhileinmemorycheckmodebyfollowingthestepslistedbelow.
1. Pressandholdthe“SET”button for3seconds.
2. Themonitorwillbeepindicating successfuldeletionandthen moveintotestingmode.
3. Totakeanotherreadingpressthe “START/STOP“buttontwice. START
STOPSET M
STARTSTOPSET M START
STOPSET M
20
EssentiA+ Instruction Manual
TIPS FOR TAKING ACCURATE READINGS
Wait at least 1 hour after eating or drinking before taking a measurement.
Avoid taking readings immediately after having tea, coffee or smoking.
Wait at least 1 hour after taking a bath before taking a measurement.
Avoid talking or moving your fingers when taking a measurement.
Avoid taking a measurement in a very cold environment.
Avoid taking a measurement when you need to use the bathroom.
EssentiA+ Instruction Manual
21
MAINTENANCE
Store in a dry place and avoid exposing to hot or cold temperatures, humidity or direct sunlight.
Avoid intense shaking or dropping unit.
Avoid storing the unit in dusty orextreme temperature environments.
Use a damp cloth to clean your blood pressure unit.
Cuff Cleaning: Do not submerge the cuff in water. Apply a small amount of rubbing alcohol to a soft cloth to clean cuff's surface. Use a damp cloth (water-based) to wipe clean. Allow cuff to dry naturally at room temperature. The cuff must be cleaned and disinfected before use between different individuals.
Avoid contact with water, wipe awayany moisture with a dry cloth.
How to clean and care for your blood pressure monitor.
• Inordertopreventpoorperformanceduetosensoraging,itisrecommended theperformanceshouldbecheckedevery2yearsonbloodpressureunit.
• Expectedservicelifeofdevice:Approximatelythreeyears,at10testsperday.
22
EssentiA+ Instruction Manual
TROUBLESHOOTING
Thetablebelowindicateshowtosolvecommonproblems thatyoumayencounterwhenusingthismonitor.Ifthe productisnotoperatingasyouthinkitshould,please checkherefirstbeforecallingcustomerservice.
PROBLEM CAUSE SOLUTION
Blood pressureresults are notwithin typicalrange
Cuff is too tight or notproperly positionedon the arm
Firmly reposition cuff approximately1 - 2 cm (0.4”- 0.8”) above the elbow joint.
Sit in a relaxed position with arm placed near heart. Avoid speakingor moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the measurement period.
Make sure air tube is properly attached to cuff and monitor unit.
Read user manual carefullyand retest properly.
Read user manual carefullyand retest properly.
Inaccurate test resultsdue to body or monitor movement
Cuff fails to inflateproperly
Pressure is over300 mmHg
Improper operation
Displayed
EssentiA+ Instruction Manual
23
PROBLEM CAUSE SOLUTION
Blood pressureresults are notwithin typicalrange
Cuff is too tight or notproperly positionedon the arm
Firmly reposition cuff approximately1 - 2 cm (0.4”- 0.8”) above the elbow joint.
Sit in a relaxed position with arm placed near heart. Avoid speakingor moving body parts while testing. Make sure the monitor unit is placed in a stationary position throughout the measurement period.
Make sure air tube is properly attached to cuff and monitor unit.
Read user manual carefullyand retest properly.
Read user manual carefullyand retest properly.
Inaccurate test resultsdue to body or monitor movement
Cuff fails to inflateproperly
Pressure is over300 mmHg
Improper operation
Displayed
24
EssentiA+ Instruction Manual
Specifications
Product Description
Model
Display
Measurement Method
Pressurization
Memory
Function
Power Source
Battery Life
Unit Weight
Unit Dimensions
Cuff Circumference
Oscillometric Method
Arm-Type Fully Automatic Blood Pressure Monitor
Essentia+
LCD Digital Display Size: 84.1mm×55.1mm (3.31" x 2.17")
120 readings in Two Groups with Date and Time
Irregular Heartbeat Detection
WHO Classification Indicator
Results Average
Low Battery Indicator
Automatic Power-Off
4 AA batteries or USB Power Source 5v 1000 mA
Approximately 2 months at 3 tests per day
USB CableMicro-USB-B Input: 100-240 V~, 50/60 Hz, 0.25 A - Output: 5VDC, 1000 mA
Approximately 382g (13.47 oz.) (excluding battery)
Approximately 148 x 100 x 56mm (5.83"x 3.94"x 2.21")(LxWxH)
Approximately 135 (W) × 485 (L) mmUniversal cuff: Fits arm circumference 22 - 42 cm (8.6" - 16.5")
Operating Evironment Humidity
Temperature
Automatic Pressurization
10 oC ~ 40 oC (50 oF~104 oF)
15%~93%RH
Pressure 700hPa~1060hPa
Measurement Range
Systolic Pressure
Pulse
Pulse
60mmHg~280mmHg
30 ~ 180 Beats/Minute
±5%
Diastolic Pressure 30mmHg~200mmHg
Pressure 0mmHg~300mmHg
Pressure ±3mmHg or ±2% above 200mmHg
EssentiA+ Instruction Manual
25
Disposal
• Pleasedisposeofthedevice,componentsandoptionalaccessories inaccordancewithlocalregulations.Unlawfuldisposalmaycause environmentalpollution.(WasteElectricalandElectronicEquipment).
• Contactyourlocaldistributorforinformationregardingdisposaloftheunit.
Storage EnvironmentHumidity
Classification:
Ingress ProtectionRating:
Temperature:
Internal Powered Equipment,Type BF . Cuff is the Applied Part
IP20, Indoor Use Only
-25 oC ~ 70 oC (-13 oF~158 oF)
≤93% RH
Specificationsaresubjecttochangewithoutnotice. International Standards:
1.IEC60601-1-2:2014-Medicalelectricalequipment-Part1-2:General requirementsforbasicsafetyandessentialperformance-CollateralStandard:Electromagneticdisturbances-Requirementsandtests
2.EN60601-1-2:2015-Medicalelectricalequipment.Generalrequirementsforbasicsafetyandessentialperformance.CollateralStandard.Electromagneticdisturbances.Requirementsandtests.
3.IEC60601-1-11:2015-Medicalelectricalequipment–Part1-11:Generalrequirementsforbasicsafetyandessentialperformance–CollateralStandard:Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment.
4.ElectromagneticCompatibility:Thisdevicefulfillsthestipulations oftheInternationalStandardIEC60601-1-2
26
EssentiA+ Instruction Manual
Electromagnetic Compatibility Information
ThedevicesatisfiestheEMCrequirementsoftheinternationalstandardIEC60601-1-2.Therequirementsaresatisfiedundertheconditions describedinthetablebelow.ThedeviceisanelectricalmedicalproductandissubjecttospecialprecautionarymeasureswithregardtoEMC whichmustbepublishedintheinstructionsforuse.PortableandmobileHFcommunicationsequipmentcanaffectthedevice.Useoftheunitin conjunctionwithnon-approvedaccessoriescanaffectthedevicenegativelyandaltertheelectromagneticcompatibility.Thedeviceshouldnotbeuseddirectlyadjacenttoorbetweenotherelectricalequipment.
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.The customer or the user of the device should assure that it is used in such an environment.
Electromagnetic environment-guidanceComplianceEmissions test
The device uses RF energy only forits internal function. Therefore, itsemissions are very low and are notlikely to cause any interference innearby electronic equipment.
Group 1,class B.
Radiated emission CISPR 11
The device is suitable for use in allestablishments, including domesticestablishments and those directlyconnected to the public low-voltagepower supply network that suppliesbuildings used for domestic purposes.
Conducted emission CISPR 11
Harmonic emissionsIEC 61000-3-2 Class A
Voltage fluctuations/flicker emissionsIEC 61000-3-3
Complies
Group 1,class B.
EssentiA+ Instruction Manual
27
Electromagnetic Compatibility Information
Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.The customer or the user of the device should assure that it is used in such an environment.
Floors should be wood, concreteor ceramic tile. If floors arecovered with synthetic material,the relative humidity should beat least 30%.
Electromagnetic environment-guidance
Compliancelevel
IEC 60601test level
IMMUNITY test
± 8 kVcontact±2 kV,±4 kV,±8 kV,±15 kV air
Electrostaticdischarge (ESD)IEC 61000-4-2
Electrostatictransient/burstIEC 61000-4-4
SurgeIEC 61000-4-5
±0.5kV, ±1kV(differentialmode)
Voltage dips,short interruptionsand voltagevariations on power supply input linesIEC 61000-4-11
0 % UT;0,5 cycleAt 0°, 45°, 90°,135°, 180°, 225°,270° and 315°0 % UT; 1 cycleand70 % UT;25/30 cyclesSingle phase:at 0°0 % UT;250/300 cycle
Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8
30 A/m; 50Hzor 60Hz
Power frequency magnetic fieldsshould be at levels characteristic of atypical location in a typical commercialor hospital environment.
30 A/m; 50Hzor 60Hz
± 8 kVcontact±2 kV,±4 kV,±8 kV,±15 kV air
± 2 kV ,100kHz, forAC power port
0 % UT;0,5 cycleAt 0°, 45°, 90°,135°, 180°, 225°, 270° and 315°0 % UT; 1 cycleand70 % UT;25/30 cyclesSingle phase:at 0°0 % UT;250/300 cycle
±0.5kV, ±1kV(differentialmode)
.
± 2 kV ,100kHz, forAC power port
Mains power quality should be thatof a typical commercial or hospitalenvironment.
Mains power quality should be thatof a typical commercial or hospitalenvironment.
Mains power quality should be thatof a typical commercial or hospitalenvironment.
28
EssentiA+ Instruction Manual
Electromagnetic Compatibility Information
Table 3
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
ConductedRF IEC61000-4-6
Radiated RFIEC 61000-4-3
Portable and mobile RFcommunications equipmentshould be used no closer to anypart of the device, includingcables, than the recommendedseparation distance calculatedfrom the equation applicable to the frequency of the transmitter.
Recommended seperation distance
80 MHz to 800 MHz
800 MHz to 2.7 Ghz
Where P is the maximum outputpower 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 fixed RFtransmitters, as determined by an electro magnetic site survey, ashould be less than the compliancelevel in each frequency range.
Interference may occur in thevicinity of equipment marked with the following symbol:
3V for 0.15-80MHz; 6V in ISM and amateur radio bands between 0.15-80MHz
3V for 0.15-80MHz; 6V in ISM and amateur radio bands between 0.15-80MHz
450MHz, 28V/m 450MHz, 28V/m
710MHz,745MHZ,780MHz9V/m
810MHz,870MHZ,930MHz28V/m
1720MHz,1845MHZ,1970MHz28V/m
2450MHz, 28V/m
5240MHz,5500MHZ,5785MHz9V/m
710MHz,745MHZ,780MHz9V/m
810MHz,870MHZ,930MHz28V/m
1720MHz,1845MHZ,1970MHz28V/m
2450MHz, 28V/m
5240MHz,5500MHZ,5785MHz9V/m
385MHz, 27V/m 385MHz, 27V/m
Electromagnetic environment-guidance
Compliancelevel
IEC 60601test level
IMMUNITY test
EssentiA+ Instruction Manual
29
Electromagnetic Compatibility Information
Table 4
Recommended separation distances between portable and mobile RFcommunications equipment and the device
The device is intended for use in an electromagnetic environment in whichradiated therefore disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communicationsequipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximumoutput power of transmitter
W
Separation distance according to frequency of transmitterm
80 MHz to 800 MHz 800 MHz to 2.7 GHz
0.01
0.1
1
10
100
0.12
0.38
1.2
3 .8
12
0.23
0.73
2.3
7 .3
23
For transmitters rated at a maximum output power not listed above, therecommended separation distance d in metres (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W) according to the transmittermanufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higherfrequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagneticpropagation is affected by absorption and reflection from structures, objects and people.
30
EssentiA+ Instruction Manual
LIFETIME LIMITED WARRANTY
A.M.G. Medical Inc. warrants this product to be free from defects in material and workmanship. This warranty is valid for the original purchaser only. Any alterations, abuse, misuse or accidental damage voids this warranty. For replacement or repair under warranty, please call: 1-800-363-2381, Monday to Friday, 8:30 AM to 5:00 PM EST.
The following voids the warranty:
A) All damage which has arisen due to improper treatment. For example, nonobservance of the user instructions.
B) Do not disassemble or attempt to repair the unit or components. All damage which is due to repairs or tampering by the customer or unauthorized third parties.
C) Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
For any questions concerning this product, please call: 1-800-363-2381 or visit our website at www.amgphysiologic.com/product/essentia-plus-blood-pressure-monitor/
EssentiA+ Instruction Manual
31
NOTES:
Model: 106-930 www.amgmedical.com
Manufactured and printed in China for: A.M.G. Medical Inc.8505 Dalton, Montréal, QC H4T 1V5Canada • 1-800-363-2381
Distributed in the USA by:
Distributed in Australia by:
AMG Medical, Inc. (USA)8396 State Route 9, West Chazy, NY 12992USA • 1-888-412-4992
Authorised Representative in the European Community M. Devices Group / E. C. REP Ltd, 5 Fitzwilliam Square East, Dublin 2 D02 R744, IrelandTel: +353 1 2 544 944 option 1Email: [email protected]
HMR Healthcare Pty Ltd33 Page Street, Kunda Park QLD 4556+61(0)7 5477 [email protected]
Rev7012
1P/N861-106930
Blood Pressure Monitor