ABIOMED Handheld Monitor Users Manual
AbioCor
Handheld Monitor
INSTRUCTIONS 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 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
© 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
Patents and patents pending.
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
About This Manual
This manual provides the Instructions for Use for the Handheld Monitor used by patients who have
received 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 Replacement
Heart System - Operator’s Manual; the AbioCor Console Alarms - User’s Guide; and the PatientCarried Electronics [PCE] - Instructions for Use.
1
Cautions
NOTE: A caution indicates a situation in which equipment may malfunction, be damaged, or cease
to operate.
• 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.
• 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. You should charge the
Handheld Monitor battery every night, whether it is used or not.
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:
• 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 Handheld
Monitor. 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.
®
3
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.
• 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.
™
Stylus
RF Expansion
Module
Charger
Handspring
PDA
5
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.
• Touch-Sensitive Screen – displays information; responds to the stylus.
• Scroll Buttons, Up/Down Arrows, and Scroll Bar – used to move through
information on the screen.
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