Abiomed AbioCor Instructions For Use Manual Download Page 4

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Contents

Cautions .............................................................................................................. 1

Overview ............................................................................................................. 2

Components of the Handheld Monitor................................................................ 3

Controls and Features ........................................................................................ 5

Resolving Alarms ................................................................................................ 7

Checking AbioCor

Status ................................................................................ 13

Checking AbioCor

Settings and Alarm History ............................................... 15

Charging the Battery......................................................................................... 19

Troubleshooting ................................................................................................ 21

Care and Cleaning ............................................................................................ 23
Appendix: Federal Communications Commission (FCC) Notice...................A.1

Summary of Contents for AbioCor

Page 1: ...AbioCor Handheld Monitor INSTRUCTIONS FOR USE...

Page 2: ...dheld Monitor The Handheld Monitor is to be used only in accordance with the Instructions for Use Manufactured by ABIOMED Inc 22 Cherry Hill Drive Danvers MA 01923 USA N America 800 422 8666 24 Hour E...

Page 3: ...ned in this document is subject to change without notice ABIOMED AbioCor and the ABIOMED logo are registered U S trademarks of ABIOMED Inc The AbioCor Implantable Replacement Heart System is covered b...

Page 4: ...held Monitor 3 Controls and Features 5 Resolving Alarms 7 Checking AbioCor Status 13 Checking AbioCor Settings and Alarm History 15 Charging the Battery 19 Troubleshooting 21 Care and Cleaning 23 Appe...

Page 5: ...e 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 Implantab...

Page 6: ...and the Handheld Monitor will interfere with each other and not allow adjustments to be made to the Implanted System If RF interference occurs turn off the Handheld Monitor The Handheld Monitor does...

Page 7: ...without 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...

Page 8: ...er draws power from the Handheld Monitor s battery even when the unit is off Handspring Personal Digital Assistant PDA standard PDA used as the interface component of the Handheld Monitor Stylus used...

Page 9: ...Components of the Handheld Monitor 4 RF Expansion Module Charger Handspring PDA Stylus...

Page 10: ...on Button used to access the AbioCor Settings Screens and Alarm History Screen Power Button turns the Handheld Monitor on and off the screen automatically turns off to save power if the unit has not b...

Page 11: ...Controls and Features 6 Life Threatening Alarm Light Application Button Up Down Arrows Scroll Buttons Scroll Bar Touch Sensitive Screen Not used Power Button...

Page 12: ...that has not been acknowledged silenced indicated by a flashing alarm message Inactive alarm an existing alarm that has been acknowledged becomes active again if it is not resolved within 2 minutes in...

Page 13: ...ween black text on 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...

Page 14: ...nued 3 When the Heart Alarm visible and audible on the PCE Module is activated move the Handheld Monitor close to the Implanted Controller stomach area and turn it on The AbioCor Alarms screen appears...

Page 15: ...op of the list a Using the stylus or your finger tap the alarm at the top of the list The Alarm Info screen appears b Follow the instructions in the first step only c Tap to acknowledge the alarm This...

Page 16: ...to the AbioCor Alarms screen d Continue in this manner performing one step at a 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 Begi...

Page 17: ...Resolving Alarms 12 6 When all alarms are resolved the AbioCor Status screen appears and the Heart Alarm indicator on the PCE Module turns off AbioCor Status Screen Heart Alarm PCE Module...

Page 18: ...ppears displaying a Check RF alarm move the 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 operati...

Page 19: ...AbioCor Status screen provides the following information CO indicates AbioCor blood flow in liters per minute L min TET indicates system voltage in VDC ABIOMED logo appears to rotate when the program...

Page 20: ...15 Checking AbioCor Settings and Alarm History 1 Press the application button twice The Exit Proceed screen appears Application Button Exit Proceed Screen...

Page 21: ...ou to access the following information see sample screens on the following pages Beat Rate current minimum and maximum settings control status manual Balance current setting control status manual or a...

Page 22: ...17 Checking AbioCor Settings and Alarm History continued 3 NOTE Tapping returns you to the AbioCor Status screen or if an alarm exists that has not been acknowledged to the AbioCor Alarms screen...

Page 23: ...Checking AbioCor Settings and Alarm History 18 4 This information concerns the most recent alarm Scroll to view the details of the 10 most recent alarms AbioCor Alarm History Screen...

Page 24: ...displayed when the battery is low Charge the Handheld Monitor s battery every night whether it is used or not When possible you should keep the backup Handheld Monitor available while the other unit i...

Page 25: ...the charger into an AC outlet The charging light blinks while the battery is charging When the light stays on the battery is charged c Unplug the charger from the outlet d Squeeze the release buttons...

Page 26: ...Remove the RF Expansion Module and then reinsert it If the screen is still frozen reset the Handheld Monitor by unscrewing the stylus tip and inserting the smaller end into the RESET hole on the back...

Page 27: ...mptom Solution The Handheld Monitor does not turn on Follow the procedure described in Charging the Battery Turn on the Handheld Monitor If the problem still exists change to the backup Handheld Monit...

Page 28: ...rain moisture or extremely dusty conditions To prevent damage to the screen be careful not to drop the Handheld Monitor or subject it to strong impact Protect the Handheld Monitor from extreme tempera...

Page 29: ...part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interfe...

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Page 32: ...ABIOMED Inc 22 Cherry Hill Drive Danvers MA 01923 USA N America 800 422 8666 24 Hour Emergency Hotline or 978 777 5410...

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