Cardionet 1007 Sensor User Manual 7 25 by 9 facing gutters

Cardionet Sensor 7 25 by 9 facing gutters

Contents

Patient Education guide

HOME HEART MONITORINGPatient Education Guide
Contents iDRAFTTABLE OF CONTENTS1. INTRODUCTION ...................................................................................... 1How the CardioNet Service Works ............................................................ 2The CardioNet Monitoring Kit ................................................................... 4Who to Call for Help ................................................................................... 82. SETTING UP ............................................................................................ 9Connecting At Home ............................................................................... 10Setting Up the Base .................................................................................. 11Checking Battery Power ........................................................................... 12Staying in Range ........................................................................................ 12Limitations of Cell Phone Coverage ....................................................... 12Wearing the CardioNet Sensor................................................................ 14Placement of Lead Wires and Pads ......................................................... 153. USING THE MONITOR .......................................................................... 17Monitor On and Off .................................................................................. 18Using the Touch Screen............................................................................ 20Recording a Symptom .............................................................................. 23When You Are Without Cell Phone Coverage ....................................... 27Changing Monitor Options...................................................................... 28Checking Monitor Status .......................................................................... 30Viewing the Cell Signal Status.................................................................. 32Warnings and Alarms ................................................................................ 334. SENSOR CARE ....................................................................................... 35Changing Electrode Pads......................................................................... 36Placing the Leads and Pads .................................................................... 39Showering or Bathing ............................................................................... 40Changing the Battery ................................................................................ 425. TROUBLE SHOOTING ........................................................................... 43Responding to Warnings and Alarms ..................................................... 44Cautions ..................................................................................................... 566. SPECIFICATIONS, COMPLIANCE AND SYMBOLS ................................ 59
iiDRAFTCaution:Caution:Caution:Caution:Caution: Federal law restricts this deviceto sale by or on the order of a physician.Copyright 2004All rights reservedModel Number 1001Lit Number - 100526 !!!!! Revision B !!!!! February 2004
Introduction 1INTRODUCTIONWe Help Find AnswersThe CardioNetService monitorsyour heart rhythmscontinuously. Thishelps your doctordetect problemsthat occurinfrequently, evenwhile you sleep.CardioNet workswith you and yourphysician.The CardioNet Service was developed to help doctorsdetect and treat heart problems that may not happenoften enough to be found during a routine ECG in thephysician’s office. CardioNet monitors heart rhythmcontinuously, while people go about their normal dailyactivities. We can help physicians detect problems thatmay occur infrequently, whether you feel them or not,even while you are sleeping.Our goal at CardioNet is to work as a team with patientsand physicians to help people receive the best possiblecare. We are honored that we were chosen to serve you.1
2 Introduction1. IntroductionHOW THE CARDIONET SERVICE WORKSWhen you’re using the CardioNet Service, you’llwear a small, lightweight sensor. The sensor monitorseach heartbeat and sends data to the portableCardioNet monitor.The CardioNet monitor can be tucked away in a pocketor purse. It sends wireless communications to theCardioNet Center automatically when it detects anevent, or when you report an event using the touchscreen on the monitor.Sensor with lead WiresLightweight sensor monitors each heartbeat.CardioNet monitor sends yourinformation to the CardioNet Center
1. IntroductionIntroduction 3CardioNet Patient Service CenterMonitors Heart RhythmsThe CardioNet Patient Service Center operates 24 hoursa day, seven days a week. At the Center, speciallytrained cardiac technicians analyze your heart rhythmsand report results to your physician.Physician Reviews ResultsYour physician reviews the results,discusses results with you and prescribesor adjusts treatment.
4 Introduction1. IntroductionTHE CARDIONET MONITORING KITThe CardioNet Monitoring Kit contains the supplies youwill need while you are on the CardioNet MonitoringService. If any items are missing or broken, or if youhave any questions about how to use them, please callthe CardioNet Patient Service Center at 1-866-426-4401.When service is ended, please return all the items totheir labeled slots and send the kit back to themonitoring center, following the directions on theenclosed return address label.It is important to return the patient supply kit no laterthan the very next day. Other patients may need to usethe equipment.YOUR SERVICE KIT CONTAINS1.1.1.1.1. The CardioNet MonitorThe CardioNet MonitorThe CardioNet MonitorThe CardioNet MonitorThe CardioNet MonitorThis portable device constantly monitors yourheartbeat and sends information to the CardioNetPatient Service Center. The CardioNet monitor useswireless communication when you are away fromhome. It uses the regular phone system when themonitor is placed in the CardioNet base station. Youwill not be charged by the telephone company forcalls made by your monitor.Please handle the CardioNet monitor withcare – don’t drop it, lose it, or get it wet.Avoid extracharges. Return allkit items exceptused batteries andused electrodepads to CardioNetwhen service iscompleted.1. CardioNet MonitorYou might receivethe latest version ofthe CardioNetMonitor, which hasa color screen.
1. IntroductionIntroduction 52.2.2.2.2. The CardioNet Base StationThe CardioNet Base StationThe CardioNet Base StationThe CardioNet Base StationThe CardioNet Base StationThe CardioNet base station is connected to yourhome telephone line and plugged into an electricaloutlet in the bedroom or a central location in yourhouse. The base station recharges the CardioNetmonitor overnight and allows the CardioNet monitorto communicate with the monitoring center throughthe regular phone system. You will not be chargedby the telephone company for calls made byyour monitor.Please put the CardioNet monitor in the base stationwhenever you are at home. In larger homes, twobase stations may be required, so you can keep yoursensor and monitor in contact as you walk aroundthe house.2. CardioNet Base Station
6 Introduction1. Introduction3.3.3.3.3. The CarThe CarThe CarThe CarThe CardioNet Sensor and Lead WdioNet Sensor and Lead WdioNet Sensor and Lead WdioNet Sensor and Lead WdioNet Sensor and Lead WiririririresesesesesThe CardioNet sensor, which can be worn around theneck or on a belt, senses each heartbeat andconstantly sends the information to the CardioNetmonitor. To communicate with the monitor, the sensormust remain within 30 feet of the monitor. Walls andother obstructions can reduce the range. If you go outof communication range, the sensor will beep to alertyou – to either move back within range or to pick upthe monitor and take it with you.4.4.4.4.4. Electrode PadsElectrode PadsElectrode PadsElectrode PadsElectrode PadsThese sticky disposable pads snap onto the threeelectrode leads on the CardioNet sensor. You removethe backing and stick them onto your skin.5.5.5.5.5. BatteriesBatteriesBatteriesBatteriesBatteriesThese batteries are for the CardioNet sensor. Thesensor battery must be replaced each day. Any newcommercially available AA battery can be used withthe CardioNet sensor.6.6.6.6.6. Sensor Neck StrapSensor Neck StrapSensor Neck StrapSensor Neck StrapSensor Neck StrapUse if you prefer to wear the sensor around your neck.7.7.7.7.7. Sensor Belt ClipSensor Belt ClipSensor Belt ClipSensor Belt ClipSensor Belt ClipUse if you prefer to wear the sensor on your belt.8.8.8.8.8. TTTTTelephone Line In/Outelephone Line In/Outelephone Line In/Outelephone Line In/Outelephone Line In/OutUse to plug your CardioNet base station into thetelephone wall jack.9.9.9.9.9. Base Power PlugBase Power PlugBase Power PlugBase Power PlugBase Power PlugUse to plug your CardioNet base station into anelectrical outlet.10.10.10.10.10.Patient Education Guide & Pocket Reference CardPatient Education Guide & Pocket Reference CardPatient Education Guide & Pocket Reference CardPatient Education Guide & Pocket Reference CardPatient Education Guide & Pocket Reference CardThese guides contain helpful information about theCardioNet service and important contact numbers.11.11.11.11.11.Patient InforPatient InforPatient InforPatient InforPatient Information Vmation Vmation Vmation Vmation VideoideoideoideoideoThis ten-minute video contains helpful informationabout the CardioNet Monitoring Service.12.12.12.12.12.ReturReturReturReturReturn Addrn Addrn Addrn Addrn Address Label and Shipping Foress Label and Shipping Foress Label and Shipping Foress Label and Shipping Foress Label and Shipping FormmmmmUse the label and prepaid shipping form to return thekit after monitoring is finished.3. CardioNet Sensor
1. IntroductionIntroduction 7PATIENT RIGHTS1. You have the right to be treated with dignity,courtesy and respect2. You have the right to high quality service3. You have the right to excellent training on how to usethe CardioNet technology and service4. You have the right to receive high quality serviceregardless of race, religion, political belief, sex, sexualpreference or source of payment5. You have the right to complain or suggestimprovements in service without worrying that wewill stop providing service or provide poorer qualityof service6. You have the right to refuse service7. By federal law (the HIPAA act) you have the right toprivacy with regard to your medical information andto control the use of that informationThe HIPAA act also provides that you have the right torequest copies of your medical records and to havecorrections made if there are errors in your records PATIENT RESPONSIBILITIES1. Use the CardioNet equipment with care2. Return equipment to CardioNet immediately, whenmonitoring is completed3. Provide CardioNet with the information we need toprovide you with quality care4. Treat CardioNet employees with respectRemember: Avoidadditional charges.All kit items, exceptused batteries andused electrode padsmust be immediatelyreturned toCardioNet onceservice is completed,or you will becharged for them.
8 Introduction1. IntroductionWHO TO CALL FOR HELPIf you have any questions about your monitoring serviceor billing, please call one of our toll free numbers.Customer service is available 24 hours a day,7 days a week.MONITORING QUESTIONS: (866) 426-4401BILLING QUESTIONS: (866) 426-4402IMPORTANT INFORMATIONCardioNet home monitoring is a service used to helpdoctors diagnose and treat rhythm problems, not anemergency response service. If you require immediatemedical assistance, you should contact EmergencyMedical Services (9-1-1 in most communities).It is possible that CardioNet could detect a problemthat needs immediate attention while a patient is beingmonitored. If we do detect a problem that needsimmediate attention, we will attempt to notify you sothat you can obtain assistance from Emergency MedicalServices. Our ability to contact and assist patients islimited by several factors such as cell phone coverage,our ability to determine patient location and differingEmergency Medical Services policies and systems inlocal communities.
Setting Up 9SETTING UPThis section describes:2" Connecting the CardioNet Base" Recharging the Battery" Staying in Communications Range" Wearing the Sensor
2. Set Up10 Setting UpCONNECTING AT HOMETo connect the CardioNet base, find an electrical outletand phone jack in a central location, preferably in yourbedroom. As long as you are within range of theCardioNet monitor, your CardioNet sensor can continuesending heartbeats to the monitor. If you go out of range,the sensor beeps to alert you.When you go to any area in your house where your sensoris out of communications range with your monitor, simplytake the CardioNet monitor out of the recharging baseand bring it with you.In larger houses, a second base station is often used sothat you can stay within range without carrying yourmonitor around.At night, keep the CardioNet monitor in the rechargingbase near your bed. If you sleep on your stomach, yourbody may block communications between the monitorand the sensor and you may need to put the sensor nextto your pillow. Whenever possible keep the monitor inthe base. It takes around four hours in the base station tocompletely recharge the monitor battery.
2. Set UpSetting Up 11SETTING UP THE BASE11111. Find an electrical outlet located close to a phone jack,preferably in your bedroom.22222. Unplug the telephone line from the back ofyour telephone.3. Take the telephone line that you just unpluggedand plug that line into the slot on the baselabeled “Phone In”.4. Locate the second telephone line included in yourCardioNet Service Kit. Plug one end of this line into theslot on the base labeled “Line Out”. Plug the other endof this line into the back of your telephone.5. Locate the power cord in your CardioNet Service Kit.Insert the small, round end of this line into the slot onthe base labeled “Power”. Plug the other end intoan outlet.PHONE IN PHONE OUTPCPOWERPhone In(yourphoneline)Line Out(phoneline fromServiceKit)Power(Insertpowerline)
2. Set Up12 Setting UpCHECKING BATTERY POWERWhen your monitor is in the base, touch the batterysymbol on the screen and the unit will tell you if thebattery is fully charged. If the battery is not fully charged,leave the monitor in the base for a full recharge, whichtakes four hours.STAYING IN RANGEThe monitor’s rechargeable battery provides between 12and 16 hours of use for each four hours of recharging. Ifyour battery indicator is low and it is still early in the day,we recommend you place the monitor in the base forrecharging. When you are at home, leave the monitor inthe base, unless you go to a part of the house where thesensor and monitor would be out of communicationsrange. Whenever you begin to go out of communicationsrange, the sensor will beep to alert you – reminding youeither return within range or take your monitor with you.LIMITATIONS OF CELL PHONE COVERAGEWhen your CardioNet monitor is in the base station, ituses the regular telephone system for communicationswith the CardioNet center. When you are away fromhome – or whenever your CardioNet monitor is out of thebase station – the monitor uses cell phone technology tocontact the CardioNet center and transmit ECG data.As with consumer cell phones, calls can sometimes bedelayed or blocked by coverage problems, heavy trafficon cell phone networks, or physical obstructions such asbuildings or mountains.See Page 20 formore details aboutchecking batterypower.At home, leave themonitor in the basewhenever possible.
2. Set UpSetting Up 13When the CardioNet monitor has data to transmit and isunable to communicate with the CardioNet center throughcell phone communications, it will save the data andtransmit it to the Center through the phone line when it isreplaced in the base.Place Monitor in Base to Recharge
2. Set Up14 Setting UpWEARING THE CARDIONET SENSORThe CardioNet sensor uses three electrode pads,carefully placed on your body to detect heartbeats bysensing electrical changes on the surface of your skin. Theelectrode pads are attached to the sensor by three leadwires: a white wire, a black wire and a red wire. The leadwires can be snapped on and off the electrodes. Thisallows you to take off the lead wires and attached sensorbefore showering – without removing the electrodes.Sensor with Lead WiresSee Page 36 for more details aboutremoving your sensor while showering.If you notice an irritation or arash developing where youplace the electrode pads,please call us. You may needto use a different type ofelectrode pad.
2. Set UpSetting Up 15Placement of Lead Wires and PadsThe electrode pads are placed as shown in thediagram below.White lead – snaps on an electrode pad placed just below the center of your right collarbone.Black lead – snaps on an electrode pad placed just belowthe center of your left collarbone.Red lead – snaps on an electrode pad placed just on your left side, on the lower part of your rib cage.Placement of Leads Shown withNeck StrapPlacement of Leads Shown withBelt BuckleWhen you enroll in the CardioNetSystem, you will be shown the bestlocations for the electrode pads todetect changes in heart rhythms.Placement of PadsUpper Right ChestUpper Left ChestLower Left Rib CageLower Left Rib CageRed LeadUpper Right ChestWhite Lead Upper Right ChestWhite LeadUpper Left ChestBlack Lead Upper Left ChestBlack LeadLower Left Rib CageRed Lead
2. Set Up16 Setting UpSKIN PREPThis is a protective barrier for patients with knownsensitivity or adhesion difficulties. Apply to clean, dry skinbefore electrode placement and allow to dry completely.Use one skin prep pad for all 3 electrodes.Alternate Placement for PadsAlternatePlacement AreasIf redness or irritation develops, you can place theelectrode pad at another location near the original site.If redness or irritation develops at the alternate site,please call the CardioNet center immediately.
Using Your CardioNet Monitor 17The CardioNet monitor is your link with the CardioNetPatient Service Center. The CardioNet sensor sends eachheartbeat to the monitor. When the monitor detects atargeted change in rhythm, or when you detect asymptom and enter your information, the monitor willestablish a communications link with the CardioNetPatient Service Center. The monitor sends your ECGdata, as well as any symptoms and activity informationyou have entered using the monitor’s touch screen.USING THE MONITORThis sectiondescribes:3" Monitor On and OFF" Using the Touch Screen" Recording a Symptom" Cell Phone Coverage" Changing Monitor Options" Checking Monitor Status" Warnings and Alarms
3. Monitor18 Using Your CardioNet MonitorMONITOR ON AND OFFKeep the monitor on at all times while you are on theCardioNet Service, unless you are changing the sensorbatteries or not wearing the sensor – for example, whenyou take a shower.See pages 38 - 41 for more informationabout how to remove the sensor whilebathing or showering.LED LightTouch ScreenWhen the monitoris awake you seethe main menu.When off or asleep,the screen is blank.Touch the buttonto wake it up.The green button at the bottom of the monitor turns iton or off and wakes it up. To turn the monitor off, youmust also use the touch screen to confirm that you want toturn the monitor off.On/Off ButtonThe CardioNet monitoruses cellular communi-cations to transmit datawhen you are away fromhome. If you have animplanted pacemakeror defibrillator, pleasefollow the manufacturer’sinstructions regardingthe use of cell phones.(See page 55 formore information.)
3. MonitorUsing Your CardioNet Monitor 19MONITOR IS ONThe LED indicator light flashes green when you arebeing actively monitored. When the light flashes red,the monitor is trying to get your attention. An alertscreen will appear with help or information.MONITOR SCREEN IS ASLEEPTo save on battery power, the monitor screenbecomes blank while you are not using the touchscreen menus. You can tell that the monitor is still onbecause the LED indicator light will be flashing.To wake the monitor up press the On/Off button. Thescreen information will appear.MONITOR IS OFFWhen you turn the monitor off, the screen is blank andthe LED indicator light is not lit.The screen isblank when themonitor is asleepor turned off.The LED light stillflashes when themonitor is asleep.It goes off whenthe monitor isturned off.
3. Monitor20 Using Your CardioNet MonitorUSING THE TOUCH SCREENThe CardioNet monitor has a simple touch screenthat is easy to view and use. To make selections, lightlytouch the screen with your finger. Each screen thatappears will guide you through the next step, usingmenus – choices you select.Most screen menus follow a simple pattern. At the top ofeach there is a prompt line that tells you the next step totake. The midsection lists options that you can choose. Atthe bottom of most menus are navigation buttons thatallow you to move from screen to screen.The two symbols at the bottom of the main menu let youcheck battery power and the strength of the cell signal.Prompt LineSelection OptionsCheck Battery and CellPhone CoverageBlack = Full or StrongWhite = Getting WeakerPress Any ButtonRecord EventView OptionsMAIN MENU
3. MonitorUsing Your CardioNet Monitor 21SYMPTOMS MENU Select SymptomsBack NextSkipped BeatLight HeadedFainted/FellShort of BreathPrompt LineSelection OptionsNavigation ButtonsNAVIGATION BUTTONSThe navigation buttons at the bottom of each menumove you from screen to screen. Here’s what thebuttons do:Confirm accepts your selection and movesto the next menu.OK acknowledges you have read the informationon the screen and closes the current menu.Back moves backward to the previous menu.Next moves forward to the next menu.Silence turns off the audio alarm.Help moves to a helpful information screen.ConfirmHelpOKBackNextSilence
3. Monitor22 Using Your CardioNet MonitorHELP MENUThe help and alert screens are slightly different in that themiddle section provides additional information. Press BackBackTo recharge Monitor battery:A) Place Monitor in BaseOR B) Insert the charger cord into the bottom of your Monitor.Prompt LineHelpful InformationNavigation Buttonto Close Screen
3. MonitorUsing Your CardioNet Monitor 23To turn yourmonitor screenon, either touchthe blank screenor press theOn/Off button.RECORDING AN EVENTYour symptom and activity data is very importantinformation that helps your physician treat or manageyour condition. By entering your symptoms and activitieseach time you have an event, you will assist yourphysician in determining the best treatment.To Record a Symptom1. Make sure the monitor is on. If the screen is blank,press the On/Off button to turn on the monitor. TheMain menu appears.Press Any ButtonRecord EventView Options2. On the Main menu touch Record Event.
3. Monitor24 Using Your CardioNet MonitorRemember thatthere are twoSymptoms menus.A confirmation screen appears asking if you want toreport an event.Press Yes or NoYes NoDo you want toreport an event?3. Touch Yes. If you have touched the Record Event screen byaccident and do not wish to report an event, touch NO and you willreturn to the Main Menu.The first first first first first of two two two two two Symptoms menus appears.Select SymptomsBack NextSkipped BeatLight HeadedFainted/FellShort of Breath
3. MonitorUsing Your CardioNet Monitor 25Select, one by one, each and every symptom that youfeel. A check mark will appear next to symptoms youselect. Touch Next.The second second second second second Symptoms menu appears.Select SymptomsBack ConfirmChest DiscomfortFatigueHeart RacingNone of the aboveSelect any or all symptoms or touchNone of the above. When done, touchConfirm to move to the Activities menu.The Activities menu appears.Select ActivityBack ConfirmRestingLight ActivityModerate ActivityHeavy Activity
3. Monitor26 Using Your CardioNet Monitor4. Choose the activity that best reflects your level ofexertion when you felt the symptom. When done,touch Confirm.The following screen appears.Press OK for Main MenuOKSelections recorded.Attempting to connect tothe CardioNet Center.5. Touch OK. The monitor then attempts to send youractivity information and your ECG data to theCardioNet Patient Service Center.
3. MonitorUsing Your CardioNet Monitor 27WHEN YOU ARE WITHOUT CELL PHONE COVERAGEWhen the CardioNet monitor is not in its base station, ituses wireless telecommunications to communicate withthe CardioNet Patient Service Center. If you are in an areawithout cell phone coverage and the monitor is unableto establish a connection with the Patient Service Center,the monitor stores the information it has collected andsends it later.Press Help or OKHelp OKCell phone unable to connect.Your Monitior will continue to redial.Press Help for options.Monitor Cannot Establish Connection
3. Monitor28 Using Your CardioNet MonitorCHANGING MONITOR OPTIONSYour CardioNet monitor lets you make adjustments to suityour needs. Adjustable features include: ! Volume ! Contrast ! Cellular Power (on or off) ! Manual Transmission Adjust Features1. Make sure the monitor is on. The Main menu appears.Press Any ButtonRecord EventView Options
3. MonitorUsing Your CardioNet Monitor 292. Touch View Options. The Options menu appears.Select OptionBackVolumeContrastCell PhoneManual TransmissionMore ...3. Choose any of the following options.Volume adjusts the alarm tone to high, medium, low orvibrate. After making your selection, you’ll hear thevolume you have chosen. For Vibrate, you can feel themonitor vibrating.Contrast adjusts the screen contrast to high, mediumor low. After you make your selection the screen willadjust to the new brightness setting. You might findyou need a different setting when you are outdoorsrather than indoors.Cell Phone turns the cell phone in the monitor OFF orON. When the cell phone is off, the monitor is stillrecording heartbeats, but no data can be sent to theCardioNet Patient Service Center until the monitor isplaced in the base.Manual Transmission is currently not available.Back returns to the Main menu.More ... allows authorized technicians to check themonitor setup and modify landline dial parameters. Seepage 30 for more information.4. After you make your selections, a screen will appear toask you to confirm the selected option. Touch Confirm.
3. Monitor30 Using Your CardioNet MonitorVERIFYING MONITOR SETUP1. From the Options menu, touch More ... The Passwordmenu appears.Enter PasswordClear Enter* * * *1 2 34 5 67 8 9* 0 #2. Enter the password. The options to verify the monitorsetup appear. The following landline dial conditionscan be modified. Pulse dialing vs. Tone dialing Dial prefix (For example, 9 to dial out, or *70 to disable call waiting.)
3. MonitorUsing Your CardioNet Monitor 31CHECKING MONITOR STATUSBy touching either the battery or the cell signal icon onthe Main menu, you can easily view more informationabout both.View the Battery Status1. From the Main menu, touch the Battery icon.Press Any ButtonRecord EventView Options2. The Battery Information menu appears.Press OKOKBattery time remainingSensor: 80%Monitor: 75%3. The screen tells you about sensor and monitor powerlevels. Touch OK to return to the Main menu.The monitor’srechargeablebattery providesbetween 12 and 16hours of use forevery four hours ofrecharging. SeeSetting Up(Page 12) formore information.Choose the Batteryicon to check thepower level of themonitor battery.
3. Monitor32 Using Your CardioNet MonitorVIEWING THE CELL SIGNAL STATUS1. From the Main menu, touch the Cell Signal icon. TheSignal Information menu appears.Press OKOKCellular signal strength:Strong2. This menu tells you how strong the cellular signal is inyour current location.When done, touch OK to return to the Main menu.Choose the CellSignal icon tocheck the strengthof the cellularsignal in yourcurrent location.
3. MonitorUsing Your CardioNet Monitor 33WARNINGS AND ALARMSThe monitor will beep to alert you when it is not able tofunction properly. The screen display will explain exactlyhow to respond.Warnings are brief beeps. Alarms last longer and growlouder. Warnings can sometimes resolve themselves, butalarms always require action on your part. With alarms,you can immediately silence the audio tones by touchingthe Silence button on the touch screen. For bothwarnings and alarms you can also touch the Help buttonfor more information on resolving the problem.Below are examples of warnings and alarms.. Press Help or OKHelp OKYour Monitor battery power is low. Recharge battery soon to ensure continuous monitoring!Press Help for instructions.“Low Monitor Battery” WarningSee Trouble Shooting(Pages 44 - 58), formore informationabout warningsand alarms.
3. Monitor34 Using Your CardioNet MonitorWARNINGS AND ALARMS CONTINUEDPress Help or OKHelp OKCell phone unable to connect.Your Monitior will continue to redial.Press Help for options.“Cannot Establish PhoneConnection” WarningPress Help or OKHelp OKSensor lead wire disconnected.Press Help for instructions. “Sensor Lead WireDisconnected” WarningPress Help or OKHelp OKYour Monitor can not detect a dial tone.Press Help for instructions. “No Dial Tone” Warning
Taking Care of the CardioNet Sensor 35The CardioNet sensor is comfortable, easy to wear, andonly requires a small amount of care. We recommendthat you change the electrode pads every two days.When you shower or bathe you don’t have to removethe electrode pads, but you must remove the sensorand electrode leads.4" Connecting the CardioNet Base" Recharging the Battery" Staying in Communications Range" Wearing the SensorSENSOR CAREThis section describes:
4. Sensor36 Taking Care of the CardioNet SensorCHANGING ELECTRODE PADSWe recommend that you change your electrode padsevery two days. Changing the electrode pads morefrequently may cause irritation to the skin. Changingelectrode pads less frequently may cause the electrodepads to wear down and weaken the heartbeat signalto the sensor.Any time you change your electrode pads you shouldturn your monitor off first, using the On/Off button andthe confirmation on the touch screen. This prevents themonitor from signaling an alarm because it cannot detectyour heartbeats. Next, remove the sensor and oldelectrode pads. Then, apply new pads.When you enrolled in the CardioNet System, you wereshown the locations for the electrode pads that wouldprovide the best possible measurements of changesin heart rhythms.When you replace electrode pads, it is important to putthe new electrode pads in the right spots. It is also veryimportant to connect the right color lead to the rightelectrode – so the CardioNet monitoring center receivesaccurate heartbeat information.
4. SensorTaking Care of the CardioNet Sensor 37Turn off the Monitor1. If the screen is blank, touch it to wake up the monitor.2. Press the On/Off button located on the front ofthe monitor.A warning appears and asks if you really want topower down.Press Yes or NoYes NoWarning: Monitoring will stop!Are you sure you want to turn the Monitor off?3. Touch Yes to confirm. A message briefly appears to letyou know that the monitor is powering down. Wait forthe monitor to completely power down. The touchscreen will become blank.
4. Sensor38 Taking Care of the CardioNet Sensor Remove Sensor and Pads1. Unsnap the sensor leads from the electrodes.2. Remove the electrode pads from your skin.Throw them away.Apply the New Pad1. Snap a new electrode pad onto the lead.2. Peel off the paper in the back of the electrode pad.3. Check the new electrode pad to make sure the gel onthe back has not dried out. Electrodes with dried gelshould be thrown away.4. Apply pad to the same spot. If the skin is irritated,move the electrode to another location near theoriginal site.Tip: If you need tochange yourelectrode pads,it’s best to doso after showeringor bathing.Lower Left Rib CagePlacement for PadsPlace the new pads in the locations you were shown when youenrolled in the CardioNet System. If redness or irritationdevelops, you can choose another location near the originalsite. (See page 16.)Upper Right ChestUpper Left Chest
4. SensorTaking Care of the CardioNet Sensor 39Electrode PadWhen you’rewearing thesensor on a beltclip, the sensor isupside down.PLACING THE LEADS AND PADSRemember that it is important to place the new electrodepads in the right spots, as close as possible to the originalpad locations. It is also very important to connect the rightcolor lead to each electrode – so the CardioNet PatientService Center receives accurate heartbeat information.White lead – snaps on an electrode pad placed just below the center of your right collarbone.Black lead – snaps on an electrode pad placed just belowthe center of your left collarbone.Red lead – snaps on an electrode pad placed just on your left side, on the lower part of your rib cage.Placement for LeadsUpper Right ChestWhite LeadThe sensor leadseasily snap onand off theelectrode pads.Upper Left ChestBlack LeadLower Left Rib CageRed Lead
4. Sensor40 Taking Care of the CardioNet SensorYou can wear yourelectrode padswhile showeringor bathing. Butbe sure youremove the sensorand electrodeleads. Aftershowering, pressthe pads to theskin to assure tightsurface contact.SHOWERING OR BATHINGYou’ll need to remove your sensor and electrode leadsbefore taking a bath or shower, but you can keep theelectrode pads on.Before removing the sensor, turn off the monitor. Removethe sensor and leads, but leave the pads in place.To keep them from falling off, try to avoid getting theelectrode pads soaked with water.Gently wash the skin around the electrodes. After drying,press the pads to the skin.Turn Off the Monitor1. Press the On/Off button located on the front of themonitor. A warning appears and asks if you really wantto power down.2. Touch Yes to confirm. A message briefly appears to letyou know that the monitor is powering down. Wait forthe monitor to completely power down. The touchscreen will become blank.
4. SensorTaking Care of the CardioNet Sensor 41 Remove the Sensor1. Remove the sensor leads from the electrodes.2. Leave the sensor electrode pads in place if you are notgoing to change them.3. If you are going to change the pads, remove them andapply a new set after your shower or bath.After showering1. Press electrode pads worn during showering to theskin or apply new pads.2. Reattach the sensor lead wires to the correct electrodepads.3. Press the On/Off button to turn the monitor on andresume monitoring.
4. Sensor42 Taking Care of the CardioNet SensorCall the CardioNetPatient ServiceCenter’s toll freenumber if you aregetting low onreplacementbatteries. Call:(866) 426-4401CHANGING THE BATTERYThe AA battery in the sensor must be replaced with anew, unused battery every 24 hours. We recommend youturn your monitor off before changing your sensorbattery. This prevents the monitor from signaling analarm because it cannot detect your heartbeats.Replace the Battery1. Pull open the battery door.2. Remove the old battery and dispose of it inaccordance with local regulations and EPA guidelines.3. Put in a new AA battery, included in your CardioNetService Kit. Insert the positive end as shown. Thesensor chimes when the battery is correctly placed.4. Close the cover.If you are getting low on replacement batteries, contactthe CardioNet Patient Service Center and ask foradditional batteries. In an emergency, any availableAA battery can be used with the CardioNet sensor.Pull the top edge of the batterydoor to open it.Insert the positive end as shown.The sensor chimes when thebattery clicks in correctly. If there’sno chime, you probably have thebattery backwards.
Trouble Shooting 43TROUBLE SHOOTINGThis section describes:5" Responding to Warnings and Alarms" Trouble Shooting" Precautions and Cautions" Cleaning" Service
5. Troubleshoot44 Trouble ShootingRESPONDING TO WARNINGS AND ALARMSThe monitor will beep to alert you when it is unableto function properly. The touch screen will explainwhat to do.Warnings are brief beeps. Alarms last longer and growlouder. Warnings can sometimes fix themselves, butalarms always require action on your part. For alarms,you can immediately silence the audio tones by touchingthe Silence button on the touch screen. With bothwarnings and alarms you can also touch the Help buttonfor more information.The following examples of alarms and warnings showwhat appears on your screen and advise you on how tosolve the problem.LOW MONITOR BATTERY WARNINGProblem: Monitor battery is low.Solution: Return the monitor to the base for recharging.Press Help or OKHelp OKYour Monitor battery power is low. Recharge battery soon to ensure continuous monitoring!Press Help for instructions.
5.TroubleshootTrouble Shooting 45LOW SENSOR BATTERY WARNINGProblem: Sensor battery is low.Solution: Install new battery. Or, if the battery isnew, inspect battery compartment and clean contactsif necessary.Press Help or OKHelp OKYour Sensor battery power is low. Replace battery soon to ensure continuous monitoring!Press Help for instructions.NO POWER IN BASE WARNINGProblem: Power cord is disconnected.Solution: Reinsert the power cable into the base andinto the wall outlet.Press Help or OKHelp OKNo power to BasePress Help for instructions.
5. Troubleshoot46 Trouble ShootingSENSOR LEAD WIRE DISCONNECTED WARNINGProblem: Either leads or pads are loose.Solution: Make sure the electrode pads are pressed ontoyour skin. Check all the lead wire attachments.Press Help or OKHelp OKSensor lead wire disconnected.Press Help for instructions.If the electrodepad loses contactor dries out youneed to replace itimmediately. Themonitor detectswhen leads aredisconnected andwill alert you.
5.TroubleshootTrouble Shooting 47POOR SENSOR COMMUNICATION WARNINGProblem: Sensor and monitor are havingtrouble communicating.Solution: Move closer to your monitor or move themonitor closer to you. The monitor and sensor need to bein closer range to communicate.Press Help or OKHelp OKPoor communications between your Monitor and your Sensor.Press Help for more information.
5. Troubleshoot48 Trouble ShootingSCHEDULED UPLOAD FAILED WARNINGProblem: Monitor needs to transmit data but can’testablish a connection.Solution: Put the monitor in the base.Press Help or OKHelp OKYour Monitor is trying to send data automatically and can not establish a phone connection.Press Help for options.
5.TroubleshootTrouble Shooting 49POOR SENSOR COMMUNICATION ALARMProblem: Sensor and monitor are not communicating.Solution: Check for causes. Is there too much distancebetween them? Are there battery problems with eitherthe sensor or monitor?Press Help or SilenceHelp SilenceNo communications between your Monitor and Sensor.Press Help for more information.
5. Troubleshoot50 Trouble ShootingEVENT TRANSMISSION ALARMProblem: Monitor has stored ECG data to transmit, butcan’t establish a connection.Solution: Move to an area that has cellular coverageor put the monitor in the base. If you still are unableto establish a connection, call the CardioNet PatientService Center for instructions.Telephone – (866) 426-4401.Press Help or SilenceHelp SilenceYour Monitor has detected an event and can not establish a phone connection.Press Help for options.
5.TroubleshootTrouble Shooting 51EMPTY MONITOR BATTERY ALARMProblem: Monitor is out of power.Solution: Place the monitor in the base.Press Help or SilenceHelp SilenceYour Monitor battery is empty. Recharge your Monitor immediately.Press Help for instructions.EMPTY SENSOR BATTERY ALARMProblem: Sensor battery is out of power.Solution: Install a new AA battery.Press Help or SilenceHelp SilenceYour Sensor battery is empty. Replace Sensor battery immediately.Press Help for instructions.
5. Troubleshoot52 Trouble ShootingINTERNAL MONITOR ALARMProblem: Monitor is not functioning.Solution: Call the CardioNet Patient ServiceCenter for help.Telephone – (866) 426-4401.Press Help or SilenceHelp SilenceInternal Monitor ErrorCall CardioNet at 1-866-426-4401 for technical assistance.Press Help for more information.
5.TroubleshootTrouble Shooting 53TROUBLE SHOOTINGTrouble shooting sometimes involves a bit of detectivework, but usually the monitor detects problems for you.The monitor beeps to let you know there is a problemand explains on the touch screen exactly how to respondon the touch screen.A warning prompts you to resolve a problem by display-ing an alert screen and beeping an audio tone. Withsome warnings the problem can fix itself and you won’tneed to take any action. With other warnings you willneed to take some action, which will be described on thetouch screen. An alarm lets you know that a problem hasnot been fixed and you must take action.MONITOR BATTERY PROBLEMSEnsure battery is being recharged for at least four hoursper day. If you find the monitor is not holding its chargelong enough, you may not have left it in the base longenough to fully recharge. The monitor must be left in itsbase for four hours to fully recharge.NO DISPLAY ON MONITORFirst, ensure the monitor is turned on. If it is on, the LEDwill be flashing and the monitor may be low on power.Return monitor to base for recharging.BEEPS IN BEDIf you wear the sensor around your neck and sleep onyour stomach, or if you wear it at your waist and sleepwith your sensor side down, you may blockcommunications between the sensor and the basestation. This will cause warning beeps. To avoid beepsand maintain the vital communications link, try placingthe sensor next to your pillow if you usually sleep onyour stomach. If you normally sleep on your side andwear the sensor with a belt clip, make sure you place thesensor on your “up” side.
5. Troubleshoot54 Trouble ShootingPHONE BUSY?When the monitor is in the base station and hasinformation to send to the CardioNet Patient ServiceCenter, it will use your telephone line to transmit ECG data.You will not be charged by the telephone company forthese calls. If someone calls you while the monitor is usingthe line, they will get a busy signal. If you try to place a callwhile the monitor is transmitting data, you will hear a high-pitched sound. This is the sound of ECG data beingtransmitted.If you are expecting a critically important call, or need toplace an urgent call while the monitor is transmitting data,you can temporarily remove the monitor from the base. Itwill either use wireless communications to transmit data tothe CardioNet Center or use your telephone line totransmit the data once it is replaced in its base. Pleaseremember to put the monitor back in the base station afteryou receive or place the telephone call.You should not interrupt an ECG transmission for routinecalls. The data that your monitor is sending might needimmediate review and response.SKIN IRRITATIONIf you notice that the skin under or around your electrodepads is becoming sensitive, irritated or painful, or if youdevelop a rash, please call the CardioNet Patient ServiceCenter. Some people are especially sensitive to differentgels and adhesives. You may need to use another type ofelectrode pad.SENSOR BELT CLIP DIFFICULT TO PUT ONIf you’re wearing a thicker belt and finding that it is difficultto slide on the Sensor Belt Clip, first remove the CardioNetSensor from the clip. Slide just the clip onto your belt andthen reposition the sensor on the clip.
5.TroubleshootTrouble Shooting 55PRECAUTIONSDISPOSE OF BATTERIES PROPERLYObserve all local laws for the disposal ofalkaline batteries.WHEN NOT IN USE, REMOVE SENSOR BATTERYDo not leave the battery in the sensor when it is not inuse. Damage from corrosion could result.AVOID ELECTROMAGNETIC INTERFERENCEFor the best recording results, you should avoid closeproximity to heavy equipment or other sources ofelectromagnetic interference such as electric blankets,heating pads, water beds, etc.POTENTIAL FOR ELECTROMAGNETIC INTERFERENCEThere is a potential for electromagnetic interference toother devices while using the CardioNet Service.THE CARDIONET SYSTEM WITH IMPLANTED PACEMAKERSAND ICDS (DEFIBRILLATORS)If you have an implanted pacemaker or defibrillator (ICD),the manufacturer may have recommended you takecertain precautions when using a cellular phone. Sincethe CardioNet monitor contains a cellular phone, youshould take the same precautions when carrying andusing the monitor. In general, most manufacturersrecommend the following:!Keep a distance of at least six inches (15 cm) betweenthe cellular phone and a pacemaker or defibrillator.!Hold the cellular phone on the opposite side of thebody from the pacemaker or defibrillator.!Don’t carry a cellular phone in a breast pocket or on abelt if that would place the phone within six inches ofthe pacemaker or defibrillator.
5. Troubleshoot56 Trouble ShootingCAUTIONSCAUTION: POWER DOWN AND REMOVE SENSORBEFORE SHOWERINGPower down the monitor and remove the sensorbefore showering. While the CardioNet sensor andmonitor are water resistant, they are not waterproof.Refer to the section: Care for the Sensor (Page 35) forcomplete instruction on removal and reapplicationbefore showering.CAUTION: DO NOT GET THE MONITOR AND SENSOR WETMake sure the monitor and sensor stay dry at all times.WARNING: FOR ADULT USE ONLYThe CardioNet Monitoring System is intended for Adultuse only. It shall not be used on infants weighing lessthan 22 lbs. WARNING: USE WITH TELEPHONE SYSTEMAny patient whose life may be put at significant risk bythe unavailability of the telephone system should not bemonitored by the CardioNet System.WARNING: NOT AN APNEA MONITORThe CardioNet monitor is not to be used as anapnea monitor.WARNING: USE ONLY CARDIONET ELECTRODESWhile wearing the CardioNet sensor, use only electrodesprovided by CardioNet.WARNING: DO NOT TAMPERThere are no serviceable parts in the CardioNetSystem. Removing the cover of any componentmay alter performance.
5.TroubleshootTrouble Shooting 57WARNING: DO NOT TAMPER WITH MONITOR BATTERYThe monitor battery can present a fire or chemical burnhazard if mistreated. Do not disassemble, heat above80C (176 F), incinerate, or recharge using any deviceother than the base.WARNING: USE ONLY CARDIONET WALL ADAPTERDo not use any wall adapter for the base other than theone provided in the CardioNet Service Kit.WARNING: DO NOT CONNECT ANY DEVICE TO THE PC PORTON THE BACK OF THE BASEThe PC port is to be used only by CardioNet personnel.WARNING: DO NOT USE NEAR FLAMMABLE ANESTHETICThe CardioNet System is not to be used in the presenceof flammable anesthetic.CLEANINGClean the plastic case of the monitor and the sensor witha soft cloth dampened with soapy water. Wipe the exter-nal surfaces of the sensor, monitor and base.Do NOT use soapy water on the touch screen. Clean thescreen of the monitor with the screen cloth or cleaningtissues provided with the patient monitoring kit.
5. Troubleshoot58 Trouble ShootingDo not spray or submerge any component with liquid orfoam. Each component should be wiped with a soft dampcloth after cleaning to ensure no fluid has pooled onexternal surfaces.SERVICEIf you experience additional problems with any compo-nents of the CardioNet Monitoring System, review theproblems and solutions listed in the trouble shootingsection. If additional assistance is required contact cus-tomer support.Telephone: (866) 426-4401.Before returning the CardioNet Monitoring System, callcustomer service to make shipping arrangements.
Specifications 59SPECIFICATIONS,COMPLIANCEAND SYMBOLSThis section describes:6" Specifications" Symbols" Hardware Requirements" FCC Compliance
60 SpecificationsSPECIFICATIONSPHYSICALSENSOR2.7 in. x 0.9 in heightWeight: 2.2 ozSENSOR NECK STRAP24 in.MONITOR5.8 in x 3.0 in x 1.1 inWeight: 12.8 ozLCD3.0 x 2.3, touch screen, monochrome, backlightBASE7.8 in x 4.3 in x 6.1 inWeight: 13.3 ozFUNCTIONALSample Rate 250 samples per secondResolution 12 bitsDynamic Range + / -5 mVBandwidth 0.5 to 40 HzChannels 2Battery Life Monitor: (12-16 hours average with clearedmemory and fully recharged battery),rechargeableSensor: (24 hr) AA AlkalineLeakage current Less than .1 µ V Electrodes)
Specifications 61TRANSMISSIONSensor to Monitor 900 MHz ISM band RF transmission, digitalerror corrected. 30 foot range, retransmission ifdata is corrupted.Monitor to Center CDMA (PCS & cellular) wireless, digital errorcorrected. Telephone line modem, digital errorcorrected. Acoustic transmission, 1500 Hz centerfrequency, 8 bits resolution, 5 mV dynamic range.ECG recording intervals vary by type of event; theminimum is 15 seconds pre-event and 45seconds post event. Wireless transmissionsubject to coverage of cellular network. Datareceived at Monitoring Center within minutes withgood wireless coverage and/or modemcommunications. Urgent reports processed attime of data receipt. Daily reports processed oncea day, by 3 PM.OPERATING CONDITIONSOperating temperature 20 - 45 o COperating humidity 10% - 95%, noncondensingStorage temperature -20 - 55 o C, noncondensingStorage humidity 5% - 95%, noncondensingOperation altitude 700-1060 millibarsFluid Ingress Rating IPX1Note: Please protect the monitor and sensor from water and other fluids. CONNECTORSBase Power in (15V, 1.2A max)Phone in (RJ-11)Phone out (RJ-11)Monitor Power in (15V, 1.2A max)WALL ADAPTERManufacturer Friwo, Inc. (15V, 1.0A)Model number FW7555M/15Note: Both the Monitor and Sensor are internally poweredcontinuous operation devices.
62 SpecificationsSTANDARDS COMPLIANCEMonitor EN60601-1AAMI EC-38FCC parts 2, 15, 22, 24Sensor EN60601-1AAMI EC-38FCC part 15Base EN60950AAMI EC-38FCC part 15, 68AECG Equipment Class IINote: This equipment has been tested and found to complywith the limits for medical devices to the IEC 601-1-2:1993,EN60601-1-2:1994, Medical Device Directive 93/42/EEC orthe Electromagnetic Compatibility Directive 89/336/EEC (useapplicable directive). These limits are designed to providereasonable protection against harmful interference in atypical medical installation. This equipment generates, usesand can radiate radio frequency energy and, if not installedand used in accordance with the instructions, may causeharmful interference to other devices in the vicinity. However,there is no guarantee that interference will not occur in aparticular installation. If this equipment does cause harmfulinterference to other devices, which can be determined byturning the equipment off and on, the user is encouraged totry to correct the interference by one or more of the followingmeasures: ! Reorient or relocate the receiving device. ! Increase the separation between the equipment. ! Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. ! Consult the manufacturer or field service technician for help
Specifications 63EQUIPMENT SYMBOLSSNConsult ManualYear of ManufactureType BF EquipmentSerial Number2000
64 SpecificationsHARDWARE REQUIREMENTSIN HOME REQUIREMENTSTouch tone or pulse telephone or good wireless coverageAC powered electrical outlet with 120 VACFCC IDSensor QBI-1007Monitor Monitor QBI-1006Monitor CDMA N7NSB555Base CARDT00B42061
Specifications 65FCC AND INDUSTRY CANADA (CS-03)COMPLIANCEThis device complies with part 15 and 68 of the FCC Rules.Operation is subject to the following two conditions: (1) Thisdevice may not cause harmful interference and, (2) This devicemust accept interference received including interference thatmay cause undesired operation.FCC RULES PART 15The Model 1001 has been tested and complies with the limitsfor a class B digital device, pursuant to Part 15 of the FCCRules. These limits are designed to provide reasonable pro-tection against harmful interference when the equipment isoperated in a residential environment. This equipment gener-ates, uses, and can radiate radio frequency energy and, if notinstalled and used in accordance with the instruction manual,can cause harmful interference to radio communications.CHANGES OR MODIFICATIONS NOT EXPRESSLYAPPROVED BY CARDIONET INC. COULD VOID THE USER’SAUTHORITY TO OPERATE THE EQUIPMENT.FCC RULES PART 68FCC Part 68 RegistrationThe Model 1001 complies with FCC Rules, Part 68. On thisequipment is a label that contains, among other information,the FCC Part 68 registration number.RENThe ringer equivalence number (REN) is used to determinethe quality of devices that may be connected to the telephoneline. Excessive RENs on the telephone line may result in thedevices not ringing in response to an incoming call. In most,but not all areas, the sum of RENs should not exceed five(5.0). To be certain of the number of devices that may beconnected to a line, as determined by the total RENs, contactthe local telephone company.
66 SpecificationsNOTE: RENs are associated with loop-start and ground-startports. It is not used for E&M and digital ports. The RENassigned to the Model 1001 is 0.01 B. If requested, this infor-mation must be given to the telephone company.SERVICEIn the event of equipment malfunction, all repairs should beperformed by CardioNet Inc. or an authorized agent. It is theresponsibility of users requiring service to report the need forservice to CardioNet Inc. or to one of our authorized agents.Service can be facilitated through our office at:CardioNet Inc.510 Market St.San Diego,CA 92101619-243-7500The telephone company can ask you to disconnect the equip-ment from the network until the problem is corrected or untilyou are sure that the equipment is not malfunctioning.The Model 1001 interface connects to the Public SwitchedTelephone Network through a FCC registered NCTE whichspecifies the type of network jack to be used.DISRUPTION OF THE NETWORKIf the Model 1001 disrupts the telephone network, the tele-phone company can discontinue your service temporarily. Ifpossible, the telephone company will notify you in advance. Ifadvance notice is not practical, they will notify you as soon aspossible. You are also informed of your right to file a com-plaint with the FCC.TELEPHONE COMPANY FACILITY CHANGESThe telephone company can make changes in its facilities,equipment, operations, or procedures that can affect theoperation of your equipment. If they do, you should be noti-fied in advance so you have an opportunity to maintainuninterrupted telephone service.
Specifications 67FCC RADIO FREQUENCY EXPOSURE INFORMATIONIn August 1996, the Federal Communications Commission(FCC) of the United States, with its action in Report andOrder FCC 96-326, adopted an updated safety standardfor human exposure to radio frequency (RF) electromag-netic energy emitted by FCC regulated transmitters. Thoseguidelines are consistent with the safety standard previ-ously set by both U.S. and international standards bodies.The design of this device complies with the FCC guide-lines and these international standards.Use only the supplied antenna. Unauthorized antennas,damaged antennas, modifications, or attachments couldimpair call quality, damage the device, or result in violationof FCC regulations. Please contact CardioNet if damage tothe unit is apparent.
68 SpecificationsBODY-WORN OPERATIONThis device was tested with the softcase sup-plied by CardioNet as an accessory to thisdevice and was found to comply with theFCC exposure requirements.When operating this device, a minimum separationdistance of 1.5 cm must be maintained between theusers body and the monitor, including its antenna, tocomply with the FCC exposure limits.To maintain compliance with FCC RF exposurerequirement, use only carrying accessories thatmaintain a 1.5 cm separation distance between theuser’s body and the device, including the antenna.These carrying accessories should not containmetallic components in its assembly. The use ofcarrying accessories that do not satisfy theserequirements may not comply with FCC RFexposure requirements, and should be avoided.This particular device has not been designed for held-to-ear use and should never be used against the ear.For more information about RF exposure, please visitthe FCC website at www.fcc.gov.
CardioNet Ambulatory ECG Systemand Arrhythmia DetectorManufactured by CardioNet Inc.510 Market StreetSan Diego, CA 92101Copyright 2002 - 2003All rights reserved.

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