1. Manuals
  2. Brands
  3. Abiomed Manuals
  4. Monitor
  5. AbioCor
  6. Instructions for use manual

Abiomed AbioCor Instructions For Use Manual

Handheld monitor
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
®
AbioCor
Handheld Monitor
INSTRUCTIONS FOR USE
®

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the AbioCor and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Summary of Contents for Abiomed AbioCor

  • Page 1 ® AbioCor Handheld Monitor INSTRUCTIONS FOR USE ®...
  • Page 2 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.
  • Page 3 © 2004 ABIOMED, Inc. All rights reserved. Information contained 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 by one or more United States...

  • Page 4: Table Of 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 ....................
  • Page 5 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 Replacement Heart System - Operator’s Manual; the AbioCor Console Alarms - User’s Guide; and the Patient-...

  • Page 6: Cautions

    • Do not use the Handheld Monitor close to an operating AbioCor ® Console. The RF signals from the AbioCor Console 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.

  • Page 7: Overview

    Overview ® The 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 AbioCor without using the Console. You can use the Handheld Monitor to: •...

  • Page 8: Components Of The Handheld Monitor

    Components of the Handheld Monitor • RF Expansion Module – allows the Handheld Monitor to communicate with the Implanted Controller; 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.
  • Page 9 ™ Handspring RF Expansion Module Charger Stylus Components of the Handheld Monitor...

  • Page 10: Controls And Features

    Life-Threatening Alarm Light – flashes when a life-threatening alarm condition exists; it also flashes briefly when the RF Expansion Module is inserted. ® • Application 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 been used for 2 minutes.
  • Page 11 Life- Threatening Up/Down Alarm Light Arrows Scroll Application Buttons Button Touch- Sensitive Screen Power Button Scroll Bar (Not used) Controls and Features...

  • Page 12: Resolving Alarms

    Resolving Alarms ® The Handheld Monitor’s AbioCor Alarms screen allows you to view two types of alarms: active and inactive. • Active alarm – an existing alarm that has not been acknowledged (“silenced”); indicated by a flashing alarm message. •...
  • Page 13 Alarms are divided into three levels: Life Threatening, Serious, and Advisory. The following message display methods are used to distinguish each level: • Life Threatening – Active: flashes between black text Life-Threatening on light background and light text on black background. Alarm Light Inactive: solid light text with black background.
  • Page 14 Resolving Alarms (continued) 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. Module Heart Alarm...
  • Page 15 The Alarm Info screen appears. b. Follow the instructions in the first step only. c. Tap to acknowledge the alarm. This ® returns you to the AbioCor Alarms screen. Alarm Check whether the alarm is still listed. Info Screen...
  • Page 16 Follow the instructions in the next step only. Scroll ® c. Tap to return to the AbioCor Alarms screen. d. Continue in this manner, performing one step at NOTE: Be sure to use the scroll bar to a time, until the alarm has cleared.
  • Page 17 ® When all alarms are resolved, the AbioCor Status screen appears, and the Heart Alarm indicator on the PCE Module turns off. Module AbioCor Heart Status Alarm Screen Resolving Alarms...

  • Page 18: Checking Abiocor Status

    ® Checking AbioCor Status Turn on the Handheld Monitor. Either the AbioCor Status screen or the AbioCor Alarms screen appears: • If the AbioCor Status screen appears, proceed to the following page. • If the AbioCor Alarms screen appears (displaying a “Check RF” alarm), move the Handheld Monitor closer to the Implanted Controller (stomach area).
  • Page 19 ® The 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 is operating.

  • Page 20: Checking Abiocor Settings And Alarm History

    ® Checking AbioCor Settings and Alarm History Press the application button twice. The Exit/Proceed screen appears. Application Button Exit/Proceed Screen...

  • Page 21: Checking Abiocor

    • Balance – current setting; control status (manual or automatic). • Motor Speed – current settings; control status (manual or automatic). Advanced Patient • Alarm History (Log) – most recent 10 alarms. Screen ® Checking AbioCor Settings and Alarm History...
  • Page 22 ® Checking AbioCor Settings and Alarm History (continued) 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

    This information concerns the most recent alarm. Scroll to view the details of the 10 most recent alarms. AbioCor Alarm History Screen ® Checking AbioCor Settings and Alarm History...

  • Page 24: Charging The Battery

    Charging the Battery CAUTION: The Handheld Monitor does not use an indicator to display the status of its battery. However, the alarm message “Handheld Battery” is 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 is charging.
  • Page 25 To 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 is charging. When the light stays on, the battery is charged. c. Unplug the charger from the outlet. Charging Light d.

  • Page 26: Troubleshooting

    Monitor by unscrewing the stylus tip and The Handheld Monitor inserting the smaller end into the RESET hole chirps repeatedly. on the back of the unit. • If the problem still exists, change to the backup Handheld ® Monitor or AbioCor Console.
  • Page 27 Symptom Solution • The Handheld Monitor Follow the procedure described in Charging the does not turn on. Battery. Turn on the Handheld Monitor. • If the problem still exists, change to the backup ® Handheld Monitor or AbioCor Console. Troubleshooting...

  • Page 28: Care And Cleaning

    Care and Cleaning • Be careful not to scratch the screen. Only use the stylus or fingers when touching the screen. 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.

  • Page 29: Appendix: Federal Communications Commission (Fcc) Notice

    (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by ABIOMED 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 the...
  • Page 32 ® ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923 USA N. America: 800-422-8666 (24-Hour Emergency Hotline) 978-777-5410...

Table of Contents