ABIOMED 0034-3340 AbioCor Implantable Controller User Manual Handheld Monitor Instructions for Use

ABIOMED Inc. AbioCor Implantable Controller Handheld Monitor Instructions for Use

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0034 3340 User Manual

Users Manual

AbioCorHandheld MonitorINSTRUCTIONS FOR USE®®

CAUTION:IMPORTANT NOTICE: Read the entire Instructions for Use before using the Handheld Monitor.The Handheld Monitor is to be used only in accordance with the Instructions for Use.Manufactured by:ABIOMED, Inc.22 Cherry Hill DriveDanvers, MA 01923 USAN. America: 800-422-8666 (24-Hour Emergency Hotline)or 978-777-5410Document No. 0034-0980-00006 Rev. A DRAFTJuly 2004

ContentsCautions..............................................................................................................1Overview.............................................................................................................2Components of the Handheld Monitor................................................................3Controls and Features........................................................................................5Resolving Alarms................................................................................................7Checking AbioCor® Status................................................................................13Checking AbioCor® Settings and Alarm History...............................................15Charging the Battery.........................................................................................19Troubleshooting................................................................................................21Care and Cleaning............................................................................................23Appendix: Federal Communications Commission (FCC) Notice...................A.1

About This ManualThis manual provides the Instructions for Use for the Handheld Monitor used by patients who havereceived the AbioCor® Implantable Replacement Heart System.These Instructions for Use are intended to be used by clinicians, caregivers, and AbioCor patients.For more information about the AbioCor System, refer to the AbioCor Implantable ReplacementHeart System - Operator’s Manual; the AbioCor Console Alarms - User’s Guide; and the Patient-Carried Electronics [PCE] - Instructions for Use.

1CautionsNOTE: A caution indicates a situation in which equipment may malfunction, be damaged, or ceaseto operate.• Do not use the Handheld Monitor close to an operating AbioCor® Console. The RF signals fromthe AbioCor Console and the Handheld Monitor will interfere with each other and not allowadjustments to be made to the Implanted System. If RF interference occurs, turn off theHandheld Monitor.• The Handheld Monitor does not use an indicator to display the status of its battery. However, thealarm message “Handheld Battery” is displayed when the battery is low. You should charge theHandheld Monitor battery every night, whether it is used or not.

Overview 2OverviewThe Handheld Monitor is a Personal Digital Assistant (PDA) that communicates with the AbioCor®Implanted Controller. This allows you to quickly access important information about the AbioCorwithout using the Console. You can use the Handheld Monitor to:• Respond to a Heart Alarm on the PCE Module.• Check AbioCor® status.• Check AbioCor® settings and alarm history.You cannot make changes to Beat Rate, Motor Speed, or Balance settings using the HandheldMonitor. These changes must be made using the Console.Before using the Handheld Monitor, you must be trained in the operation of the PCE and the Console.

3Components of the Handheld Monitor• RF Expansion Module – allows the Handheld Monitor to communicate with theImplanted Controller; draws power from the Handheld Monitor’s battery (even whenthe unit is off).• Handspring™ Personal Digital Assistant (PDA) – standard PDA used as theinterface component of the Handheld Monitor.• Stylus – used to select items on the screen (fingers can also be used).• Charger – plugs into an AC outlet to charge the Handheld Monitor’s battery.

Components of the Handheld Monitor 4RF ExpansionModuleChargerHandspring™PDAStylus

5Controls and Features• Life-Threatening Alarm Light – flashes when a life-threatening alarm conditionexists; it also flashes briefly when the RF Expansion Module is inserted.• Application Button – used to access the AbioCor® Settings Screens and AlarmHistory Screen.• Power Button – turns the Handheld Monitor on and off; the screen automaticallyturns off (to save power) if the unit has not been used for 2 minutes.• Touch-Sensitive Screen – displays information; responds to the stylus.• Scroll Buttons, Up/Down Arrows, and Scroll Bar – used to move throughinformation on the screen.

Controls and Features 6Life-ThreateningAlarm LightApplicationButtonUp/DownArrowsScrollButtonsScroll BarTouch-SensitiveScreen(Not used)PowerButton

7Resolving Alarms1The Handheld Monitor’s AbioCor® Alarms screen allows you to view two types ofalarms: active and inactive.• Active alarm – an existing alarm that has not been acknowledged (“silenced”);indicated by a flashing alarm message.• Inactive alarm – an existing alarm that has been acknowledged; becomes activeagain if it is not resolved within 2 minutes; indicated by a solid (not flashing)alarm message.NOTE: Alarms that have been resolved without action or acknowledgement may be displayed assolid alarm messages.

Resolving Alarms 82Alarms are divided into three levels: Life Threatening, Serious, and Advisory. Thefollowing message display methods are used to distinguish each level:• Life Threatening – Active: flashes between black texton light background and light text on black background.Inactive: solid light text with black background.• Serious – Active: flashes between black text and textured text.Inactive: solid black text.• Advisory – Active: flashes “INFO” between black text and textured text.Inactive: solid black text.Life-ThreateningAlarm LightNOTE: The Life-Threatening Alarm Light also flashes red for Active and Inactive.

9Resolving Alarms (continued)3When the Heart Alarm (visible and audible) on the PCE Module is activated, movethe Handheld Monitor close to the Implanted Controller (stomach area) and turn iton. The AbioCor® Alarms screen appears.HeartAlarmPCEModule

Resolving Alarms 104Alarms are listed in order of importance. The most important alarm is at the top ofthe list.a. Using the stylus (or your finger), tap the alarmat the top of the list. The Alarm Info screenappears.b. Follow the instructions in the first step only.c. Tap to acknowledge the alarm. Thisreturns you to the AbioCor® Alarms screen.Check whether the alarm is still listed.AlarmInfoScreen

11Resolving Alarms (continued)5If the alarm is still listed:a. Tap the alarm. The Alarm Info screen appears.b. Follow the instructions in the next step only.c. Tap to return to the AbioCor® Alarms screen.d. Continue in this manner, performing one step ata time, until the alarm has cleared.If the alarm is no longer listed, tap the alarm that is now at the top of the list. Beginagain with the procedure described on the previous page.NOTE: Be sure to use the scroll bar toview additional instructions that do not fiton a single screen.ScrollBar

Resolving Alarms 126When all alarms are resolved, the AbioCor® Statusscreen appears, and the Heart Alarm indicator onthe PCE Module turns off.AbioCorStatusScreenHeartAlarmPCEModule

13Checking AbioCor® Status1Turn on the Handheld Monitor. Either the AbioCor Status screen or the AbioCorAlarms screen appears:• If the AbioCor Status screen appears, proceed to the following page.• If the AbioCor Alarms screen appears (displaying a “Check RF” alarm), movethe Handheld Monitor closer to the Implanted Controller (stomach area). The“Check RF” alarm should clear.CAUTION: Do not use the Handheld Monitor close to an operating AbioCor® Console.The RF signals from the Console and the Handheld Monitor will interfere with eachother and not allow adjustments to be made to the Implanted System. If RF interferenceappears, turn off the Handheld Monitor.

15Checking AbioCor® Settings and Alarm History1Press the application button twice. The Exit/Proceed screen appears.ApplicationButtonExit/ProceedScreen

Checking AbioCor® Settings and Alarm History 162Tap on the Exit/Proceed screen. The Advanced Patient screen appears. Thisscreen allows you to access the following information (see sample screens on thefollowing pages):• Beat Rate – current, minimum, and maximumsettings; control status (manual).• Balance – current setting; control status(manual or automatic).• Motor Speed – current settings; control status(manual or automatic).• Alarm History (Log) – most recent 10 alarms.AdvancedPatientScreen

17Checking AbioCor® Settings and Alarm History (continued)3NOTE: Tapping returns you to the AbioCor Status screen (or, if an alarm exists that hasnot been acknowledged, to the AbioCor Alarms screen).

Checking AbioCor® Settings and Alarm History 184This information concernsthe most recent alarm.Scroll to view the details ofthe 10 most recent alarms.AbioCorAlarm HistoryScreen

19Charging the Battery1CAUTION: The Handheld Monitor does not use an indicator to display thestatus of its battery. However, the alarm message “Handheld Battery” isdisplayed when the battery is low.Charge the Handheld Monitor’s battery every night, whether it is used or not. Whenpossible, you should keep the backup Handheld Monitor available while the otherunit is charging. It takes about 90 minutes to charge the battery.NOTE: The screen remains on during charging, even if the Handheld Monitor was turned off prior tocharging.

Charging the Battery 202To charge the battery:a. Plug the charger connector into the Handheld Monitor.b. Plug the charger into an AC outlet. The charging light blinks while the battery ischarging. When the light stays on, the battery is charged.c. Unplug the charger from the outlet.d. Squeeze the release buttons(between thumb and forefinger) andunplug the charger connector.ReleaseButtonsChargingLightChargerConnector

21TroubleshootingSymptom SolutionThe screen is frozen, ORThe Handheld Monitorchirps repeatedly.• Remove the RF Expansion Module and thenreinsert it.• If the screen is still frozen, reset the HandheldMonitor by unscrewing the stylus tip andinserting the smaller end into the RESET holeon the back of the unit.• If the problem still exists,change to the backup HandheldMonitor or AbioCor® Console.

Troubleshooting 22Symptom SolutionThe Handheld Monitordoes not turn on. • Follow the procedure described in Charging theBattery. Turn on the Handheld Monitor.• If the problem still exists, change to the backupHandheld Monitor or AbioCor® Console.

23Care and Cleaning• Be careful not to scratch the screen. Only use the stylus or fingers when touching thescreen. Do not use pens, pencils, or other sharp objects on the screen.• The Handheld Monitor is not waterproof and should not be exposed to rain, moisture,or extremely dusty conditions.• To prevent damage to the screen, be careful not to drop the Handheld Monitor orsubject it to strong impact.• Protect the Handheld Monitor from extreme temperature environments (such as thedashboard of a closed car during hot weather), heaters, and other heat sources.• To clean the Handheld Monitor, use a soft, damp cloth. To clean the screen, use a softcloth moistened with diluted window-cleaning solution.

A.1AbioCor Components NoticeAbioCor® Console This device complies with Part 18 of the FCC Rules.PCE Control Module This device complies with Part 18 of the FCC Rules.RF CommunicationModule This device complies with part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) This device may not cause harmful interference, and(2) this device must accept any interference received, including interference that maycause undesired operation. Changes or modifications not expressly approved byABIOMED Inc. could void the user’s authority to operate the device.Handheld Monitor This device complies with part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) This device may not cause harmful interference, and(2) this device must accept any interference received, including interference that maycause undesired operation. Changes or modifications not expressly approved byABIOMED Inc. could void the user’s authority to operate the device.Implantable Controller This device complies with part 15 of the FCC Rules. Operation is subject to thefollowing two conditions: (1) This device may not cause harmful interference, and(2) this device must accept any interference received, including interference that maycause undesired operation. Changes or modifications not expressly approved byABIOMED Inc. could void the user’s authority to operate the device.Appendix: Federal Communications Commission (FCC) Notice

ABIOMED, Inc.22 Cherry Hill DriveDanvers, MA 01923 USAN. America: 800-422-8666 (24-Hour Emergency Hotline)or978-777-5410®