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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 Drive
Danvers, MA 01923 USA

N. America: 800-422-8666 (24-Hour Emergency Hotline)
or 978-777-5410

Document No. 0034-0980-00006 Rev. A

DRAFT

July 2004

Содержание AbioCor

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 30: ......

Страница 31: ......

Страница 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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