ABIOMED Implantable Replacement Heart System Users Manual
AbioCor
Implantable Replacement Heart System
PATIENT-CARRIED ELECTRONICS MANUAL
®
®
AbioCor
Implantable Replacement Heart System
PATIENT-CARRIED ELECTRONICS MANUAL
ABIOMED, Inc.
22 Cherry Hill Drive
Danvers, MA 01923 USA
978-777-8411 (fax)
clinical@abiomed.com (email)
www.abiomed.com
®
N. America: 800-422-8666 (24-Hour Emergency Hotline)
or 978-777-5410
July 2004
Document No. 0034-0980-00016 Rev. 1 DRAFT
Humanitarian Device. Authorized by Federal law for use in the treatment of patients
who have irreparably damaged hearts or who are at risk of imminent death as a result of
end-stage heart failure not treatable by optimal medical treatment. The effectiveness of
this device for these uses has not been demonstrated.
IMPORTANT NOTICE: Read this entire manual before using the Patient-Carried
Electronics (PCE). The PCE is to be used only in accordance with this manual.
Information contained in this document is subject to change without notice.
© 2004 ABIOMED, Inc. All rights reserved.
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.
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
Contents
Glossary...............................................................G.1
Introduction
About this Manual.................................................1
Manual Overview..................................................1
Definitions of Special Terms..................................2
1Warnings and Precautions
AbioCor System Warnings.................................1.1
Patient-Carried Electronics (PCE) Warnings......1.3
AbioCor System Precautions.............................1.3
Patient-Carried Electronics (PCE) Precautions..1.5
2 PCE Overview
What is the Patient-Carried Electronics
(PCE)?...............................................................2.1
Parts of the PCE................................................2.2
PCE Battery Bag................................................2.3
PCE Batteries....................................................2.5
Battery Cable.....................................................2.6
External TET......................................................2.7
PCE Control Module..........................................2.7
Battery Charger..................................................2.8
AC Power Adapter.............................................2.9
3 Basic PCE Operation
PCE Control Module Functions..........................3.2
Battery Bag Switch and Indicators......................3.3
Charging Batteries.............................................3.5
Getting the PCE Ready for Use..........................3.7
Changing a Pair of PCE Batteries....................3.10
Calibrating Batteries.........................................3.12
Connecting the AC Power Adapter...................3.13
Cleaning the PCE.............................................3.14
© 2004 ABIOMED, Inc.
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
4 Transferring Support Between the Console
and the PCE
Transferring Support from the Console to the PCE...4.2
Transferring to the PCE if You Use
the Same TET....................................................4.2
Transferring to the PCE if You Use
a Different TET...................................................4.5
Transferring Support from the PCE to the Console...4.9
Transferring to the Console if You Use
the Same TET....................................................4.9
Transferring to the Console if You Use
a Different TET.................................................4.13
5 PCE Alarms
What are the PCE Alarms?......................................5.1
PCE Battery Bag Alarms..........................................5.2
PCE Control Module Alarms.....................................5.3
Appendix: Federal Communications Commission
(FCC) Notice.......................................................A.1
Figures
Figure 2.1: Using the PCE.....................................2.1
Figure 2.2: Parts of the PCE..................................2.2
Figure 2.3: PCE Battery Charger...........................2.3
Figure 2.4: AC Power Adapter...............................2.3
Figure 2.5: PCE Battery Bag with Batteries
Installed...............................................2.4
Figure 2.6: PCE Battery.........................................2.5
Figure 2.7: PCE Control Module with TET..............2.7
Figure 2.8: PCE Battery Charger...........................2.8
Figure 2.9: AC Power Adapter for the PCE............2.9
Figure 3.1: PCE Control Module Panel..................3.2
Figure 3.2: Location of the Battery Charge
Indicator...............................................3.5
Figure 3.3: Battery Charger Status Lights..............3.6
Figure 3.4: Installing the PCE Batteries..................3.8
Figure 3.5: Plugging the Battery Cable into the
PCE Control Module............................3.8
ABIOMED, Inc. © 2004
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
Figure 3.6: Plugging the TET into the PCE
Control Module....................................3.9
Figure 3.7: Changing Batteries............................3.10
Figure 3.8: Connecting the AC Power Adapter....3.13
Figure 4.1: Installing Batteries in the Battery Bag..4.2
Figure 4.2: Plugging the Battery Cable into the
PCE Control Module............................4.3
Figure 4.3: Silencing the TET Alarm......................4.3
Figure 4.4: Console TET Unplugged......................4.3
Figure 4.5: Silencing Console Alarms....................4.3
Figure 4.6: Connecting the TET to the PCE
Control Module....................................4.4
Figure 4.7: Console Power Panel After Transfer
to PCE.................................................4.4
Figure 4.8: Testing PCE Alarms............................4.4
Figure 4.9: Checking the Heart Alarm Light...........4.4
Figure 4.10:Putting the Console on Standby...........4.5
Figure 4.11:Installing Batteries in the Battery Bag..4.5
Figure 4.12:Plugging the Battery Cable into the
PCE Control Module............................4.6
Figure 4.13:Removing the Console TET.................4.6
Figure 4.14:Console TET Unplugged......................4.6
Figure 4.15:Silencing Console Alarms....................4.6
Figure 4.16:Connecting the TET to the PCE
Control Module....................................4.7
Figure 4.17:Silencing the PCE TET Alarm..............4.7
Figure 4.18:Checking the Console Power Panel.....4.8
Figure 4.19:Testing PCE Alarms............................4.8
Figure 4.20:Checking the Heart Alarm Light...........4.8
Figure 4.21:Putting the Console on Standby...........4.8
Figure 4.22:Bringing the Console out of Standby....4.9
Figure 4.23:Silencing Console Alarms....................4.9
Figure 4.24:Checking the RF Communications
Signal................................................4.10
Figure 4.25:Silencing the PCE TET Alarm............4.10
Figure 4.26:Connecting the TET to the Console...4.11
Figure 4.27:Checking TET Alignment and Power
on Console Power Panel...................4.11
Figure 4.28:Removing the PCE Batteries
from the Battery Bag..........................4.12
© 2004 ABIOMED, Inc.
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
Figure 4.29:Charging the Used Batteries..............4.12
Figure 4.30:Bringing the Console out of
Standby..............................................4.13
Figure 4.31:Checking the RF Communications
Signal.................................................4.13
Figure 4.32:Silencing the PCE TET Alarm............4.14
Figure 4.33:Connecting the TET
to the Console....................................4.14
Figure 4.34:Checking TET Alignment and Power
on Console Power Panel....................4.15
Figure 4.35:Removing the PCE Batteries
from the Battery Bag..........................4.15
Figure 4.36:Charging the Used Batteries..............4.16
Figure 5.1: PCE Control Module Panel..................5.1
Tables
Table 3.1: PCE Battery Bag Panel...........................3.4
Table 3.2: Battery Charger Status Lights..................3.7
Table 5.1: PCE Battery Bag Alarms..........................5.2
Table 5.2: PCE Control Module Alarms....................5.3
ABIOMED, Inc. © 2004
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
Glossary
Glossary
AbioCor Replacement
Heart
alternating current (AC)
cardiopulmonary
resuscitation (CPR)
Console
External Transcutaneous
Energy Transfer coil (TET)
heart rate
implanted
Implanted Battery
battery-powered system that takes the place of the
natural heart to keep the blood flowing normally
through the body
normal household electrical power
first-aid technique that uses pressure against the chest
to restore the operation of a natural heart
specialized computer that powers and controls the
AbioCor System
silicone ring containing a coil of wire; transfers energy
from the Console to the implanted components of the
AbioCor System
number of times per minute the Replacement Heart
pumps blood
placed inside your body by a surgeon
AbioCor component that provides power to the
Implanted Controller and the Replacement Heart
Implanted Controller
AbioCor component that manages the heart rate and
stroke volume of the Replacement Heart to provide the
needed blood flow
Implanted Transcutaneous
Energy Transfer coil (TET)
AbioCor component that receives electrical energy
through your skin from the External TET to keep your
AbioCor System charged
magnetic resonance
imaging (MRI)
Patient-Carried Electronics
(PCE)
© 2004 G.1 ABIOMED, Inc.
diagnostic technique that produces images of the inside
of the body using electromagnetic energy
portable system that provides battery power to the
implanted AbioCor System through an External TET
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
precaution
information that alerts you to situations that carry a risk
of minor injury to you, or situations in which the
AbioCor Replacement Heart may malfunction or be
damaged
Replacement Heart
Glossary
the AbioCor component that is implanted in your chest
to pump blood to your lungs and other parts of your
body
RF
radiofrequency; the type of communications signal
used by the AbioCor System
RF Communications
Module
external AbioCor component that sends data between
the Console and the AbioCor Implanted Controller
through the implanted RF Antenna
TET
transcutaneous energy transfer coil (implanted and
external); transfers power from the Console to the
implanted AbioCor System
warning
information that alerts you to situations that can cause
death or serious injury
ABIOMED, Inc. G.2 © 2004
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
Introduction
The AbioCor Replacement Heart is a battery-powered system for
patients with heart failure or another serious heart disease. It takes
the place of your natural heart to keep the blood flowing normally
through your body.
The Patient-Carried Electronics (PCE) is a portable system that
provides power to the implanted AbioCor System. It allows you to
keep your AbioCor Replacement Heart working smoothly while
you are away from the AbioCor Console.
About this Manual
This manual will help you understand how to use the PCE safely
and comfortably.
Introduction
Manual Overview
After you read this introduction, take a moment to browse through
this manual, so you’ll know where to find the information you
need.
• Section 1 (Warnings and Precautions) lists important
precautions to avoid potential safety problems and ensure that
you get the best results from your AbioCor System.
• Section 2 (PCE Overview) describes the parts of the
Patient-Carried Electronics (PCE).
• Section 3 (Basic PCE Operation) tells how to use the PCE
and how to charge, replace, and calibrate Batteries. It also tells
how to clean the system.
© 2004 1 ABIOMED, Inc.
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
• Section 4 (Transferring Support Between the Console
and PCE) tells how to transfer support from the AbioCor
Console to the PCE when you want to be away from the
Console and how to transfer support from the PCE back to the
Console.
Introduction
• Section 5 (PCE Alarms) describes the alarms you might see
and hear when you are using the PCE.
Definitions of Special Terms
This manual may use words that are new to you. Those terms are
printed in bold type (like this) and listed in alphabetical order in
the Glossary at the front of this manual. The Glossary also includes
abbreviations used in this manual.
ABIOMED, Inc. 2 © 2004
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
1 Warnings and Precautions
This section contains two kinds of information.
• Warnings alert you to situations that can cause death or
serious injury. The word “WARNING” and the symbol
appear before warning messages.
• Precautions alert you to situations that carry a risk of minor
injury to you, or situations in which the AbioCor Replacement
Heart may malfunction or be damaged. The word “CAUTION”
and the symbol appear before precaution messages.
AbioCor System Warnings
1 Warnings and Precautions
WARNING: Call your doctor or clinic immediately if the AbioCor System
Console stops working.
If the Console stops working, connect the Patient-Carried Electronics (PCE)
to provide power immediately.
The AbioCor Replacement Heart will work for only about 30 minutes using
its Implanted Battery power. After that, your AbioCor Replacement Heart
must be connected to the Console or PCE for power. Otherwise, it will stop
working, resulting in death.
WARNING: If the External TET is removed, the AbioCor System runs on
its Implanted Battery power, which only lasts for about 30 minutes.
When the Implanted Battery runs down, the AbioCor System will slow
down, lowering your blood pressure. This might make you feel dizzy or
faint. If the Implanted Battery runs down completely, the AbioCor System
will stop working, resulting in death.
© 2004 1.1 ABIOMED, Inc.
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
WARNING: Never undergo a magnetic resonance imaging (MRI)
procedure.
The strong magnetic energy produced by an MRI machine may cause the
AbioCor System components to give you an electric shock. An MRI may
also damage the AbioCor System’s electronics.
WARNING: Never administer cardiopulmonary resuscitation (CPR) to a
person who has an AbioCor Replacement Heart.
CPR will not work with an AbioCor Replacement Heart, and may cause lifethreatening bleeding.
1 Warnings and Precautions
WARNING: Never travel in any airplane.
WARNING: Never travel to an altitude that is more than 2,500 feet higher
or lower than the location at which the AbioCor Replacement Heart was
implanted.
If emergency air transportation is needed, tell the pilot about the 2,500-foot
restriction.
Changes in air pressure caused by altitude changes may cause the AbioCor
Replacement Heart to work incorrectly, resulting in death or serious injury.
WARNING: Do not allow anything metal (such as jewelry, keys, metal
buttons, or zippers) to remain within 3 inches of the AbioCor TET when it is
attached to your chest. Metal objects will become hot.
WARNING: If you have an X-ray, the technician may put a lead shielding
apron over your chest.
Put a thick pad (a Styrofoam® block or a folded towel at least 3 inches thick)
between the AbioCor TET and the lead shielding apron, or remove the TET
for a short time during the X-ray.
Without a thick pad, the AbioCor System components may get hot during the
X-ray, causing a risk of a skin burn.
ABIOMED, Inc. 1.2 © 2004
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
Patient-Carried Electronics (PCE) Warnings
WARNING: When using the PCE, you must always have at least one of the
following backup units available within 10 minutes:
• a PCE Battery Bag and 2 pairs of fully-charged Batteries
• a fully-charged AbioCor Console
If the PCE fails and no backup unit is available, the AbioCor System may stop
working, resulting in death.
WARNING: If the PCE Temperature alarm stays on for more than 1 minute,
transfer AbioCor System control immediately to a backup PCE or the Console.
This warning indicates that the PCE is overheated and may malfunction.
AbioCor System Precautions
CAUTION: Do not bend forward deeply from the waist. This posture might be
uncomfortable because of the location of the Implanted Battery and Implanted
Controller in your abdomen.
Bending forward may also affect the blood flow to your upper body, which
may cause a momentary fainting spell.
CAUTION: Do not clean the TET, Radiofrequency (RF) Communications
Module, or cables with disinfectants that contain oxidizers such as iodine
(Betadine® or similar disinfectants), hydrogen peroxide, hypochlorite (chlorine
bleach), permanganate, or chromate.
1 Warnings and Precautions
These cleaners may break down the outer coverings of these AbioCor
components.
CAUTION: Do not clean the TET, RF Communications Module, or cables
with cleaners that may stain the surfaces you are cleaning.
This staining may hide the breakdown of the outer coverings of these AbioCor
components.
CAUTION: Do not allow any liquids (including water) to come in contact with
any electrical connector pins.
Contact with liquid may cause corrosion or electrical malfunction.
© 2004 1.3 ABIOMED, Inc.
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
CAUTION: Keep a TET that is connected to the Console at least 1 foot away
from any other TET (for example, the PCE TET.)
This precaution prevents potential damage to the TET’s electronics.
CAUTION: Never place a TET that is connected to the PCE or Console on a
metal surface.
The TET may become overheated, causing a fire hazard.
CAUTION: Disconnect the TET from the Console when it is not in use (for
example, when you are using the PCE.)
1 Warnings and Precautions
This precaution reduces the risk that the TET will be damaged by accidentally
coming in contact with metal surfaces.
CAUTION: Keep the Console away from sources of electromagnetic
radiation (EMR) such as cell phones, 2-way radios, or appliances with electric
motors if you observe signs of interference (for example, static on the phone
or radio or on the AbioCor Console screen).
These devices may interfere with the AbioCor's communications system.
Patient-Carried Electronics (PCE) Precautions
CAUTION: Never try to disassemble the PCE Control Module, Battery Bag,
or Batteries.
You may damage the PCE and cause it to operate incorrectly.
CAUTION: Always have 2 power sources connected to the PCE to ensure
that you will be able to see and hear alarms if they occur. These power
sources can be:
• 2 pairs of Batteries
• 1 pair of Batteries and an AC Power Adapter.
CAUTION: Never remove Batteries while they are supplying power to the
PCE.
You may damage the PCE and cause it to operate incorrectly.
ABIOMED, Inc. 1.4 © 2004
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
CAUTION: Never cover the PCE with clothing.
Covering the PCE may cause it to overheat and operate incorrectly.
CAUTION: Never block the PCE’s cooling vents.
Blocking the cooling vents may cause the PCE to overheat and operate
incorrectly.
CAUTION: Never use a PCE Battery that has been dropped. It may not
work correctly.
If you drop a PCE Battery, mark it DO NOT USE and return it to your doctor
or clinic.
CAUTION: Never submerge any part of the PCE in liquid.
Liquids will severely damage the PCE and cause it to operate incorrectly.
1 Warnings and Precautions
© 2004 1.1 ABIOMED, Inc.
AbioCor® Implantable Replacement Heart Patient-Carried Electronics (PCE) Manual
2 PCE Overview
What is the Patient-Carried Electronics (PCE)?
The Patient-Carried Electronics (PCE) is a portable system that
provides battery power to the implanted AbioCor System through
the External TET. The PCE is carried in a nylon Battery Bag that
you can wear over your shoulder. The PCE allows you to be
mobile, away from the Console, for extended periods of time.
Like the Console, the PCE monitors your AbioCor System, using
lights and sounds to tell you if there is a problem with the system.
Figure 2.1 shows how the PCE is used.
2 PCE Overview
Figure 2.1 Using the PCE
© 2004 2.1 ABIOMED, Inc.
Patient-Carried Electronics (PCE) Manual AbioCor® Implantable Replacement Heart
Parts of the PCE
The PCE includes the following parts, which are shown in Figures
2.2, 2.3, and 2.4.
• Battery Bag
• Batteries (2 pairs)
2 PCE Overview
• External TET
• PCE Control Module
• Battery Charger
• AC Power Adapter
• Handheld Monitor (not shown; described in a separate manual)
• Battery cable
Figure 2.2 Parts of the PCE
ABIOMED, Inc. 2.2 © 2004
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