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

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Document ID	452541
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Document Description	Users Manual
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Document Type	User Manual
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Date Submitted	2004-07-22 00:00:00
Date Available	2004-10-13 00:00:00
Creation Date	2004-07-15 14:45:49
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Document Title	Handheld Monitor Instructions for Use.doc
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Document Author:	rdambrosio

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.
Overview
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.
Handspring™
PDA
RF Expansion
Module
Charger
Stylus
Components of the Handheld Monitor
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.
LifeThreatening
Alarm Light
Up/Down
Arrows
Scroll
Buttons
Application
Button
TouchSensitive
Screen
Power
Button
Scroll Bar
(Not used)
Controls and Features
7
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.
•
Inactive alarm – an existing alarm that has been acknowledged; becomes active
again 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 as
solid alarm messages.
2
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
on light background and light text on black background.
Inactive: solid light text with black background.
Life-Threatening
Alarm Light
NOTE: The Life-Threatening Alarm Light also flashes red for Active and Inactive.
•
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.
Resolving Alarms
9
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.
PCE
Module
Heart
Alarm
4
Alarms are listed in order of importance. The most important alarm is at the top 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
returns you to the AbioCor® Alarms screen.
Check whether the alarm is still listed.
Resolving Alarms
Alarm
Info
Screen
10
11
Resolving Alarms (continued)
If 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
Scroll
Bar
to return to the AbioCor® Alarms screen.
d. Continue in this manner, performing one step at
a time, until the alarm has cleared.
NOTE: Be sure to use the scroll bar to
view additional instructions that do not fit
on a single screen.
If the alarm is no longer listed, tap the alarm that is now at the top of the list. Begin
again with the procedure described on the previous page.
6
When all alarms are resolved, the AbioCor® Status
screen appears, and the Heart Alarm indicator on
the PCE Module turns off.
PCE
Module
Heart
Alarm
AbioCor
Status
Screen
Resolving Alarms
12
13
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). 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 each
other and not allow adjustments to be made to the Implanted System. If RF interference
appears, turn off the Handheld Monitor.
2
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.
CO
Checking AbioCor® Status
TET
ABIOMED
logo
14
15
Checking AbioCor® Settings and Alarm History
Press the application button twice. The Exit/Proceed screen appears.
Application
Button
Exit/Proceed
Screen
2
Tap
on the Exit/Proceed screen. The Advanced Patient screen appears. This
screen allows you 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 automatic).
•
Motor Speed – current settings; control status
(manual or automatic).
•
Alarm History (Log) – most recent 10 alarms.
Advanced
Patient
Screen
Checking AbioCor® Settings and Alarm History
16
17
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).
4
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
18
19
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. 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 to
charging.
2
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.
d. Squeeze the release buttons
(between thumb and forefinger) and
unplug the charger connector.
Release
Buttons
Charging the Battery
Charging
Light
Charger
Connector
20
21
Troubleshooting
Symptom
The screen is frozen,
OR
Solution
•
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 of the unit.
•
If the problem still exists,
change to the backup Handheld
Monitor or AbioCor® Console.
The Handheld Monitor
chirps repeatedly.
Symptom
The Handheld Monitor
does not turn on.
Solution
•
Follow the procedure described in Charging the
Battery. Turn on the Handheld Monitor.
•
If the problem still exists, change to the backup
Handheld Monitor or AbioCor® Console.
Troubleshooting
22
23
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.
•
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 temperature environments (such as the
dashboard 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 soft
cloth moistened with diluted window-cleaning solution.
Appendix: Federal Communications Commission (FCC) Notice
AbioCor Components
®
Notice
AbioCor 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 Communication
Module
This device complies with 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 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
following two conditions: (1) This device may not cause harmful interference, and
(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.
Implantable Controller
This device complies with 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 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.
A.1
®
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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Title                           : Handheld Monitor Instructions for Use.doc
Author                          : rdambrosio
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Create Date                     : 2004:07:15 14:45:49
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