HeartMate® Universal
Battery Charger
INSTRUCTIONS FOR USE (IFU)
for Charging HeartMate12 Volt NiMH & 14 Volt Li-Ion Batteries
Corporate Headquarters
Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
Business:
Tel.: 925-847-8600
Fax: 925-847-8574
Emergencies:
800-456-1477 (USA HeartLine™)
925-847-8600 (International)
www.thoratec.com
Document # 103771.B
1/2011
Table of Contents
WARNINGS & PRECAUTIONS 1
Warnings 1
Precautions 2
INTRODUCTION 4
1.0 Overview 4
2.0 Setting Up the Universal Battery Charger Prior to Use 5
2.1 Plugging In and Turning On the Charger 5
2.2 Selecting Language/Display Panel Settings 9
USING YOUR UNIVERSAL BATTERY CHARGER 12
3.0 Charging Batteries 12
3.1 Battery Charging (Overview) 12
3.2 Charging Batteries (Procedure) 15
3.3 Viewing Battery Information on the UBC Screen 18
4.0 Calibrating HeartMate Batteries 21
RESPONDING TO ADVISORY MESSAGES 24
5.0 Monitoring Performance 24
5.1 Battery-Related Advisory Messages 24
5.2 Charger-Related Advisory Messages 26
INSPECTION, CLEANING & MAINTENANCE 28
6.0 Routine Inspection and Cleaning 28
7.0 Product Disposal 29
8.0 Testing and Classification 29
APPENDICES 31
APPENDIX 1: Technical Specifications – HeartMate Universal Battery Charger
(UBC) (p/n 1440)___________ 31
APPENDIX 2: Description of English Text and Graphic Symbols Appearing on
The UBC Display Panel 33
APPENDIX 3: Graphic Symbols Found on HeartMate UBC
Labels and Labeling 34
HeartMate Universal Battery Charger IFU i
Warnings and Cautions
Warnings
• Understanding the operating and the safety aspects of HeartMate products is essential
for safe and successful use. All users (including clinicians, patients, and caregivers)
must be trained on system operation and safety aspects before use.
• A thorough understanding of the technical principles, clinical applications, and risks
of left ventricular support is necessary before using this product. Read this entire
HeartMate Universal Battery Charger Instructions for Use (IFU) and the
corresponding HeartMate II or HeartMate XVE LVAS IFU, Operating Manual, and
/or Patient Handbook before use.
• Before using any HeartMate power accessories (Power Module/Power Base Unit,
batteries, Universal Battery Charger), all users (including clinicians, patients, and
caregivers) must be trained on their use. Manuals for HeartMate power accessories
include:
- HeartMate 12 Volt NiMH Battery Instructions for Use (IFU) (document #
103769)
- HeartMate 14 Volt Li-Ion Battery IFU (document # 103770)
- HeartMate Universal Battery Charger IFU (document # 103771)
- HeartMate Power Module IFU (document # 103772)
• HeartMate batteries must be charged prior to use. Before removing a battery from the
Universal Battery Charger (UBC), check that the battery has completed its charge or
calibration cycle, then remove the battery and check its charge level using the battery
fuel gauge. See Section 3.0, Charging Batteries.
• Ensure you are using the correct batteries before relying on them for power.
Using the wrong batteries for an incompatible system will result in pump failure.
HeartMate 14 volt lithium ion (Li-Ion) batteries are for use exclusively
with the
HeartMate II LVAS. They are NOT compatible with the XVE system and cannot
power the XVE LVAS. HeartMate 12 volt nickel metal hydride (NiMH) batteries are
capable of powering both
the HeartMate II and XVE LVAS (see the HeartMate 12
Volt NiMH Battery IFU).
• The HeartMate Universal Battery Charger (UBC) generates, uses, and can radiate
radio frequency energy. If not installed and used according to instructions, it may
cause harmful interference with other devices in the area. There is no guarantee that
interference will not occur in a particular installation/use of the Universal Battery
Charger (UBC). Interference can be determined by turning off/on the Universal
Battery Charger (UBC) and seeing the affect on devices in the area. If interference is
detected, attempt to correct it by:
⋅ Re-orienting or moving the affected device(s).
⋅ Increasing the distance between the Universal Battery Charger (UBC) and the
affected device(s).
HeartMate Universal Battery Charger IFU 1
⋅ Connecting the affected device(s) to an electrical outlet different from the outlet
used to power the Universal Battery Charger (UBC).
⋅ Consulting Thoratec’s Technical Services Department for advice and assistance.
• Using equipment and supplies other than those specified in this manual or sold by
Thoratec for replacement parts may affect the electromagnetic compatibility of the
Universal Battery Charger (UBC) with other devices. This may result in potential
interference between the UBC and other devices.
• The Universal Battery Charger (UBC) should not be used next to other equipment or
stacked on top of or with other equipment. The normal operation of the Universal
Battery Charger (UBC) must be verified if the charger is used in these configurations.
• Connect the Universal Battery Charger (UBC) (and any peripheral devices) only to
properly tested and grounded AC outlets dedicated to battery charger use. Do not use
an adapter for ungrounded wall outlets or multiple portable socket outlets (power
strips), or the risk of electrocution increases.
• Do not connect the Universal Battery Charger (UBC) to electrical outlets controlled
by a wall switch, or the charger may be left inoperable.
• If traveling internationally, you will need a Thoratec power cord set that is compatible
with the local voltage and that meets applicable national plug, rated voltage, rated
current, and safety agency marks and specifications. Ask your VAD Coordinator for a
Thoratec power cord set, if needed.
• Keep the Universal Battery Charger (UBC) away from water or moisture. If the UBC
has contact with water/moisture, rain/snow, shower spray, or wet surfaces, you may
get a serious electric shock or your Charger may fail to operate properly.
• Do not use the UBC near flammable anesthetic agents (such as nitric oxide), or an
explosion may occur.
• The HeartMate UBC cannot test or charge the black sealed lead acid (SLA)
HeartMate batteries originally used with the HeartMate Power Base Unit (PBU)
(catalog #2025).
Precautions
• Use only the HeartMate Universal Battery Charger (UBC) to charge HeartMate 12
volt NiMH and 14 volt Li-Ion batteries. Other battery chargers may damage
HeartMate batteries.
• Service and maintenance of the HeartMate UBC should be performed only by service
personnel who are trained and authorized by Thoratec Corporation.
• Make sure the UBC is plugged in and turned on (“I”) before placing batteries into the
pockets for charging.
• After approximately 70 uses, HeartMate batteries may need to be recalibrated. The
UBC indicates when a battery needs to be recalibrated. Calibration can take up to 12
HeartMate Universal Battery Charger IFU 2
hours, and only one battery can be calibrated at a time. Calibrate a battery as soon as
possible after being prompted to prevent a backlog of uncalibrated batteries (see
Section 4.0, Calibrating HeartMate Batteries).
• Leave a calibrating battery in the UBC for the full calibration cycle. Removing a
battery before it is fully calibrated may result in a depleted battery (the on-battery fuel
gauge will reflect this status) (see Section 4.0, Calibrating HeartMate Batteries).
• The metal contacts inside the UBC pockets should be kept clean and dry. Do not
expose contacts to water, moisture, dirt, etc. Do not touch these contacts when the
charger is connected to AC mains and turned on (“I”).
• Dirty metal contacts inside the battery charging pockets may prevent proper battery
charging, which can affect battery operation. The metal contacts inside the pockets
should be cleaned at least once a month. Unplug the UBC before cleaning. Use a lintfree cloth or swab that has been moistened (not dripping) with rubbing alcohol. Allow
the alcohol to dry before inserting batteries into the pocket(s) for charging. See
Section 6.0, Routine Inspection and Cleaning.
HeartMate Universal Battery Charger IFU 3
INTRODUCTION
WARNING! A thorough understanding of the technical principles, clinical
applications, and risks of left ventricular support is necessary before using this
product. Read this entire HeartMate Universal Battery Charger Instructions for Use
(IFU) and the corresponding HeartMate II or HeartMate XVE LVAS IFU, Operating
Manual, and /or Patient Handbook before use.
1.0 Overview
The HeartMate Universal Battery Charger (UBC) (Figure 1) is designed to
charge the HeartMate batteries used to power the HeartMate II LVAS or
HeartMate XVE LVAS during mobile operation. Specifically, the HeartMate
UBC can:
• Charge up to four HeartMate 12 volt NiMH batteries or four 14 volt Li-Ion
batteries in four hours or less (see Section 3.0, Charging Batteries).
• Monitor the need for calibration and calibrate individual HeartMate 12 volt
NiMH batteries or 14 volt Li-Ion batteries (see Section 4.0, Calibrating
HeartMate Batteries).
• Perform diagnostic testing on up to four HeartMate 12 volt NiMH batteries or
14 volt Li-Ion batteries at once (see Section 5.0, Monitoring Performance).
CAUTION! Use only the HeartMate Universal Battery Charger (UBC) to
charge HeartMate 12 volt NiMH or 14 volt Li-Ion batteries. Other battery
chargers may damage HeartMate batteries.
HeartMate Universal Battery Charger IFU 4
Figure 1 HeartMate Universal Battery Charger (UBC) with empty charging pockets (front view)
2.0 Setting Up the Universal Battery Charger Before Use
Before using the HeartMate UBC (Figure 1) to charge HeartMate batteries, it
must be plugged in and turned on. In addition, you should select the
language/display panel setting best for your needs. These steps are described
below.
2.1 Plugging In and Turning On the Charger
Follow these steps for setting up the UBC:
1 If not already unpacked, carefully remove the UBC from its
product packaging. Place the charger on a flat, sturdy surface.
2 Inspect the charger for dents, chips, cracks, or other signs of
damage. Do NOT use a UBC that seems damaged. Contact your
VAD Coordinator or hospital contact person for a replacement, if
needed.
3 Examine the four battery charging pockets. Make sure the pockets
are clean and empty (no batteries), and free of dust or debris. Note:
Pay particular attention to the metal contacts inside the pockets.
HeartMate Universal Battery Charger IFU 5
Dirt or objects covering the metal contacts inside the pockets may
prevent proper battery charging, which can affect battery
performance.
4 Obtain the grey AC power cord from the product packaging.
5 Plug the female end of the power cord into the power entry module
in the rear of the charger (Figure 2). Make sure the cord is fully
inserted and secure.
Figure 2 Inserting power cord into power entry module (rear of
Universal Battery Charger)
6 Plug the male end of the power cord into a properly-tested and
grounded (3-prong) AC mains electrical outlet that is not
controlled by a light switch. Note: If traveling internationally, you
will need a Thoratec power cord set that is compatible with the
local voltage and that meets applicable national plug, rated voltage,
rated current, and safety agency marks and specifications. Ask
your VAD Coordinator for a Thoratec power cord set, if needed.
WARNING!
• Connect the HeartMate Universal Battery Charger (UBC) only to properly-
tested and grounded (3-prong) AC outlets. Do not use an adapter plug or
portable, multiple outlet (power strip) for ungrounded wall outlets.
• Ensure the UBC is connected to AC power and is turned “on” before
placing batteries into the pockets for charging
7 Turn on the UBC by pressing the on/off switch in the rear of the
charger from the off (“0”) to the on (“I”) position (Figure 3). Note:
Once the charger is turned on, all lights on the front panel will turn
HeartMate Universal Battery Charger IFU 6
8 If the UBC detects a problem during the self test, an error message
OR
on (Figure 5), and the charger will beep once. This means the
charger is performing a self test. The test takes about 10 seconds.
When it is done, all the lights will turn off, unless there is a
problem (see Step 8).
Figure 3 On/off switch in the "on" position ( I ) (rear of Universal Battery
Charger)
appears on the display panel screen (Figure 4) and/or the lights
and beep will not perform as described above. Note: If you get an
error message, and/or the lights or beep are missing or do not
perform as described, refer to Section 5.0, Monitoring
Performance for how to respond to advisory messages.
Figure 4 Sample error message (when in Graphics mode)
(close up)
8 If the charger passes the self test, “HeartMate CHARGER” appears
on the display panel (Figure 6). The charger is now ready for use.
Note: Any time the “HeartMate CHARGER” message is displayed,
the display panel will slowly dim, turn off for two seconds, and
then brighten again to full brightness. This helps to prolong the life
of the display (Figure 6). You may use the UBC during this time.
HeartMate Universal Battery Charger IFU 7
)
Charging Pocket
Lights (green,
yellow, red)
Display Panel
Pocket Number
Button (numbers
1–4 corresponds
with pocket
location
Figure 5 Display panel during self test
Figure 6 "HeartMate CHARGER" message (default screen)
HeartMate Universal Battery Charger IFU 8
2.2 Selecting Language/Display Panel Settings
The display panel on the front of the HeartMate Universal Battery Charger
(UBC) displays messages about how the charger is working or about the
status of the battery(ies) in the charging pocket(s).
There are two language/display options for the display panel screen:
• English Text
• Graphic Symbols
“Graphic Symbols” is the default display mode.
Selecting the Language/Display Panel Setting
Before Using the Charger for the First Time
Follow these instructions for switching from the default (“Graphic
Symbols”) setting to the “English Text” setting before using the charger
for the first time:
1 Unpack and plug in the UBC as outlined in Section 2.1. However,
do NOT turn on the charger at this time.
2 At the same time, press and hold buttons #1 and #3 on the front
panel of the UBC (Figure 7).
Note location of
Note location of
buttons #1 and
buttons #1 and
#3
#3
Figure 7 Numbered buttons on front of charger correspond with locations of charging
pockets. Note locations of buttons #1 and #3.
HeartMate Universal Battery Charger IFU 9
3 While still holding buttons #1 and #3, turn on the UBC by pressing
the power switch from the off (“0”) to the on (“I”) position.
4 After the “English” display appears (Figure 8), release buttons #1
and #3.
Figure 8 Display panel showing English language display mode option
5 If “English Text” is the desired display setting, press and release
the #1 button. Note: After releasing the button, the charger will
conduct a self test. If the test is successful, “HeartMate
CHARGER” will appear on the screen.
OR
5 If “Graphic Symbols” is the desired setting, press and release the
#2 button to scroll down to “Graphics,” then press and release
button #1. Note: After releasing the button, the charger will
conduct a self test. If successful, “HeartMate CHARGER” will
appear on the screen.
Selecting the Language/Display Panel Setting Anytime After Startup
“Graphic Symbols” is the default display mode. Follow these instructions
for changing the display mode anytime after initial setup (see Section 2.0,
Setting Up the Universal Battery Charger (UBC) Before Use):
1 Remove all batteries from the charging pockets.
2 Turn off the UBC by pressing the on/off switch from the on (“I”)
to the off (“0”) position. Note: Do not unplug the charger.
3 At the same time, press and hold
buttons #1 and #3 on the front
panel of the UBC.
4 While still holding buttons #1 and #3, turn on the charger by
pressing the power switch from the off (“0”) to the on (“I”)
position.
5 After the display screen appears (Figure 9), release buttons #1 and
#3). The UBC will power up.
HeartMate Universal Battery Charger IFU 10
Figure 9 Display panel showing current language/display setting
(English language)
6 Use the #2 button to scroll down to the desired language/display
panel setting.
7 When the desired language/display panel setting appears on the
screen, press and release the #1 button. After releasing the button,
the charger will conduct a self test. If the test is successful,
“HeartMate CHARGER” will appear on the screen.
8 Repeat Steps 1 – 7 any time after initial set up to select or change
the desired language/display panel setting.
Note: Avoid covering or blocking the vents on the top of the UBC during
use. Covering or blocking the vents may affect device performance.
HeartMate Universal Battery Charger IFU 11
USING YOUR UNIVERSAL BATTERY CHARGER
3.0 Charging Batteries
3.1 Battery Charging (Overview)
The HeartMate Universal Battery Charger (UBC) can charge up to four
HeartMate 12 volt NiMH or 14 volt Li-Ion batteries at the same time. It
takes up to four hours to charge from one to four batteries, depending on
the charge status of the battery(ies) being charged. Be sure to plan battery
use and charging with the four-hours in mind.
For best battery performance, leave charged batteries in the charging
pockets until ready for use. Leaving charged batteries in the charger will
not damage them.
HeartMate 12 volt NiMH batteries and 14 volt Li-Ion batteries utilize a
“smart” technology that measures available battery power and counts
battery usage/charge cycles. Once a battery is placed into a charging
pocket (Figure 10), the UBC immediately checks that battery’s status by
reading the battery’s on board computer chip. Information about the
battery (available power and total number of use/charge cycles) can be
viewed on the UBC’s display panel by pressing the number button for that
pocket (see Section 3.3, Viewing Battery Information on the UBC Screen).
Figure 10 Batteries inserted into Universal Battery Charger pockets #2 and #4. Note
yellow lights indicate charge status of batteries (yellow = charging).
Batteries
in Pockets
#2 and #4
HeartMate Universal Battery Charger IFU 12
Depending on the status of the battery, one of three lights (yellow, green,
or red) located near the number button for this pocket will come on
(Figure 11). A steady yellow light means that the battery is actively
charging. Green means the battery is charged and ready for use. Red
means the battery is defective or that there is a problem with the charger.
See Table 1 for a complete description of charger pocket light color
codes.
Figure 11 Charge status lights (green, yellow, red) for charging pockets 1 - 4
UBC Charger Pocket Light Indicators
Light Color Status/Meaning
Green
Yellow
Yellow (Blinking)
Red
Table 1 Color codes for charging pocket lights
Battery is charged and ready for use
Battery is undergoing test or charge
Battery requires calibration cycle
Battery or charging pocket is defective,
Do not use battery*
* Before assuming that a battery is defective, first remove it from the pocket
and then reinsert it into the same pocket. If again there is a red light (or no
light), insert the battery into a different pocket. Try cleaning the metal
contact on the batteries and inside the pocket (let them dry). If there
continues to be is a red light (or no light), the battery is defective. Do not
HeartMate Universal Battery Charger IFU 13
use it. Contact your VAD Coordinator or hospital contact person for help
and for a replacement, if needed. See Section 5.0, Monitoring
Performance for information on advisory messages and troubleshooting,
including how to read alarm codes when a red light comes on
WARNING!
• Ensure you are using the correct batteries before relying on them for
power. Using the wrong batteries for an incompatible system will result in
pump failure.
• The HeartMate 12 volt nickel metal hydride (NiMH) batteries can power
both
the HeartMate II LVAS and the HeartMate XVE LVAS.
• The HeartMate14 volt lithium ion (Li-Ion) batteries are NOT
interchangeable between the HeartMate II and the HeartMate XVE
systems. HeartMate 14 volt Li-Ion batteries are for use exclusively
HeartMate II LVAS. They are NOT compatible with the XVE system and
cannot power the XVE LVAS. Do NOT use HeartMate 14 volt Li-Ion
batteries with the HeartMate XVE LVAS.
with the
HeartMate Universal Battery Charger IFU 14
3.2 Charging Batteries (Procedure)
Follow these instructions for charging HeartMate 12 volt NiMH batteries
and 14 volt Li-Ion batteries:
1 Obtain one or more HeartMate 12 volt NiMH or 14 volt Li-Ion
batteries.
CAUTION!
• Do not attempt to test or charge non-HeartMate batteries in the
HeartMate Universal Battery Charger (UBC). Doing so may
damage the charger or the batteries, or injure the user.
• Do not attempt to test or charge the black sealed lead acid (SLA)
HeartMate batteries originally used with the HeartMate Power Base
Unit (PBU) (catalog #2025). Doing so may damage the charger or
the batteries, or injure the user.
2 Place one of the HeartMate batteries into one of the four battery
charging pockets, with the battery fuel gauge on the top and facing
forward (Figure 12). Note: Do not force a battery into a charging
pocket. Batteries will fit only one way into a pocket (with the
battery’s battery fuel gauge at the top and facing forward as shown
in Figure 12). A beep and one of the pocket lights coming on (red,
yellow, or green) confirms the battery is properly placed in the
pocket.
Figure 12 Batteries inserted into charging pockets #2 and #4
3 After hearing the beep, look at the three lights (yellow, green, and
red) next to the number button for this pocket (Figure 13). Note:
The UBC has four charging pockets. Numbers 1 – 4 on the front
panel of the charger correspond to the location of each pocket. For
example, “1” on the panel stands for the front left pocket; “2”
stands for the front right pocket; “3” stands for the rear left; and
“4” stands for the rear right pocket.
HeartMate Universal Battery Charger IFU 15
Figure 13 Charge status lights. Note yellow light for pocket #1. In this
case, the battery in pocket #1 is charging.
4 Identify which of the three lights (yellow, green, or red) comes on
for this pocket.
5 If the yellow light comes on, the battery is actively charging. Do
nothing with the battery. Leave the battery in the pocket to
continue charging and skip to Step 7. If a blinking yellow light is
observed, see section 4.0 Calibrating HeartMate Batteries. Note:
The yellow light will remain on until the battery becomes charged.
Once the battery becomes charged, the yellow light turns off and
the green light comes on.
OR
5 If the green light comes on, the battery is already charged and
ready for use. Either remove the battery for immediate use, or
leave the battery in the pocket until needed. Note: Leaving charged
batteries in the charger will not damage them.
OR
5 If the red light comes on (or no light at all), there is a problem with
the battery or the charging pocket. Note: Remove the battery and
reinsert it into the same pocket. If again there is a red light (or no
light), insert the battery into a different pocket. If the battery
cannot be charged in a different pocket, the battery is defective. Do
not use the defective battery. Contact your VAD Coordinator or
hospital contact person for help and for a replacement, if needed.
See Section 5.0, Monitoring Performance for information on
advisory messages and troubleshooting, including how to read
alarm codes when a red light comes on.
HeartMate Universal Battery Charger IFU 16
6 After approximately four hours, look at the three lights near the
charging pocket for this battery. Note: It takes up to four hours to
charge one to four batteries, depending on the original charge
status of the battery(ies) being charged.
7 If the green light is on, the battery is charged and ready for use.
OR
7 If the yellow light is on, the battery is still charging.
OR
7 If the red light is on, there is a problem with the battery and/or the
UBC interrupted the charging cycle for some reason. See Section
5.0, Monitoring Performance for how to handle red light
conditions.
8 Repeat Steps 2 – 8 for as many as three more batteries, to charge
up to four batteries at the same time (Figure 14).
Figure 14 Batteries inserted into all four charging pockets
HeartMate Universal Battery Charger IFU 17
3.3 Viewing Battery Information on the Universal Battery
Charger (UBC) Screen
To check a battery’s charge status, place the battery into a charging
pocket, then press and release the number button for that pocket. The
following will appear on the display panel (Figure 15):
• Pocket Number
• Battery symbol
• Percentage of available charge
For example, if approximately 50% of the battery’s power is available
(i.e., battery is 1/2 charged), half of the battery symbol is filled and
“50%” appears on the screen.
After five seconds, the display returns to the default screen (“HeartMate
CHARGER”), unless the number button for this pocket is pressed again.
Pressing the button a second time brings up the total number of
use/charge cycles (see immediately below).
To see how many times a battery has been used/charged, press and release
the number button while the Charge Status Screen (Figure 15) is still on.
The following will appear on the display panel (Figure 16):
• Pocket Number
• Total number or uses/charges for this battery
• How much power the battery can potentially hold if fully charged
(measured in mAh)
After 10 seconds, the display panel returns to the default (“HeartMate
CHARGER”) screen (Figure 13).
HeartMate Universal Battery Charger IFU 18
Figure 15 Viewing available power for the battery in pocket #1 (in Graphics
mode). In this case, the battery is approximately 90% charged.
Figure 15 Viewing available battery power (sample screen)
Figure 16 Battery cycle count (in this case 7 cycles) and charger capacity (in
mAh) for the battery in pocket #1 (sample only).
HeartMate Universal Battery Charger IFU 19
If a battery is being calibrated (see Section 4.0, Calibrating HeartMate
Batteries), the pocket number and a split battery symbol appear on the
display panel when the number button for that pocket is pressed (Figure
17). Note: Five seconds after pressing the button, the display returns to the
default (“HeartMate CHARGER”) screen (Figure 13).
Figure 17 Display panel screen (in Graphics mode) when button is pressed to
start battery calibration cycle. In this case, the battery in pocket #4 needs
calibration.
See Appendix 2 for a complete list of display panel symbols and
messages.
HeartMate Universal Battery Charger IFU 20
4.0 Calibrating HeartMate Batteries
HeartMate 12 volt NiMH and 14 volt Li-Ion batteries use a “smart” technology
that measures available battery power and counts battery usage/charge cycles.
Periodically (approximately every 70 battery uses), the battery may sense that it
needs to calibrate its battery fuel gauge. Calibration helps keep the battery’s fuel
gauge accurate.
During calibration, the UBC drains the battery of all electrical energy and then
recharges it. The battery must be placed into the UBC to be calibrated. Battery
calibration can take up to 12 hours, and only one battery can be calibrated at a
time. During calibration, the other three HeartMate batteries can be charged as
usual.
If a battery needs to be calibrated, the UBC will tell you when that battery is
inserted into one of the charging pockets. The following occurs if calibration is
recommended:
• The yellow light for this pocket blinks
• A split battery symbol and the pocket number for this battery flashes on the
display panel screen (Figure 18). Note: The circled number will switch
between a filled and unfilled circle as the display panel screen flashes.
Figure 18 Calibration prompt (in Graphics mode). In this case, the battery in pocket #4
needs calibration.
You have the choice of calibrating the battery when prompted or waiting for
another, more convenient time (e.g., at night while sleeping). If you choose to not
calibrate at the prompt, after ten seconds, the charger will continue with a normal
charge cycle for this battery (see Section 3.2, Charging Batteries). It is OK to use
a battery (once recharged) if you delayed its calibration. But, you should calibrate
it as soon as possible.
If you choose to calibrate the battery, and then decide to cancel it after the process
has already begun, you can cancel calibration by removing the battery from its
pocket. If you do remove a battery before calibration is complete, make sure
to recharge and check the battery before using it. Removing a battery before
HeartMate Universal Battery Charger IFU 21
calibration ends may result in a depleted battery (the on-battery fuel gauge will
reflect this status).
Note: It is important to calibrate a battery as soon as possible after being prompted
to do so. This helps ensure the best possible battery performance. Be sure to have
enough charged batteries when planning for calibration, which can take up to 12
hours. For example, under normal conditions, having four charged batteries will
allow you to exchange batteries twice during a 12-hour calibration cycle.
Follow these steps to calibrate a HeartMate 12 volt NiMH or 14 volt Li-Ion
battery:
1 Receive a calibration prompt from the charger (blinking yellow light,
broken battery symbol on display panel screen) (Figure 18).
2 If you do not want to calibrate the battery now, do nothing. After ten
seconds, the UBC will continue to charge the battery as usual (see Section
3.2, Charging Batteries).
OR
2 If you do want to calibrate the battery now, within ten seconds of the start
of the blinking yellow light, press and release the number button for this
pocket.
Note: During calibration, the yellow light for this pocket remains on and
“HeartMate CHARGER” appears on the display panel screen, unless the
number button for this pocket is pressed. Pressing the number button
during calibration brings up the calibration status screen for the battery
(Figure 19). Once calibration is complete, the yellow light turns off and
the green light comes on. Green means the battery is charged and ready for
use.
CAUTION! Leave a calibrating battery in the Universal Battery Charger for
the entire calibration cycle. Removing the battery before it is fully calibrated
may result in a depleted battery (the on-battery fuel gauge will reflect this
status).
HeartMate Universal Battery Charger IFU 22
Figure 19 Calibration status display (in Graphics mode). In this case, the
battery in pocket #4 is calibrating.
HeartMate Universal Battery Charger IFU 23
RESPONDING TO ADVISORY MESSAGES
5.0 Monitoring Performance
The HeartMate Universal Battery Charger (UBC) is continually monitoring its
own performance and that of any battery placed into a pocket. Actual or potential
problems, or “faults,” appear as “advisory messages” on the display panel screen.
5.1 Battery-Related Advisory Messages
If the UBC detects a problem with the battery (e.g., battery voltage too
high or too low, battery open circuit), the red light for this pocket comes
on and a telephone symbol appears on the display panel (Figure 20).
Figure 20 Advisory message (in Graphics mode) for battery/pocket #1. Note
red light.
Before assuming the battery is defective, make sure dirt or debris is not
blocking the connection between the battery and charging pocket contacts:
1 Remove the battery. Examine the battery’s metal contact and the
contact inside the charging pocket. If there is no dirt, debris, or
obstruction, continue with Step 2.
2 Reinsert the battery into the same pocket.
3 If, again, the red light comes on, insert the battery into a different
pocket.
4 If the red light comes on in the second pocket, the battery is
defective. Do not use it.
5 Obtain the alarm code for this battery, if possible:
a Press and hold number button for this pocket to display the
HeartMate Universal Battery Charger IFU 24
alarm code on the screen. Note: The battery alarm code will be
one letter followed by four numbers. Alarm codes related to
batteries begin with the letter “B.”
b Record the alarm code for this battery (e.g., write it on a piece
of paper), check its accuracy, and save the code for future
reference, if needed.
6 Call your VAD Coordinator or hospital contact person for help or
for a replacement battery, if needed. Note: The VAD Coordinator
or hospital contact person may ask for the alarm code.
7 Remove the defective battery from use.
.
CAUTION! Dispose of (or recycle) expired, used, or damaged
batteries according to local, state, and federal regulations. Do NOT
incinerate.
HeartMate Universal Battery Charger IFU 25
5.2 Charger-Related Advisory Messages
The Universal Battery Charger (UBC) can detect a problem or “fault” condition
with up to four charging pockets at once (with or without batteries inside), or with
the entire charger unit. The UBC will alert you immediately of any problems.
Detecting Pocket Faults
If the UBC detects a pocket fault, the red light for the affected pocket(s) (with or
without battery(ies) inside) will come on. In addition, the UBC will immediately
stop charging or calibrating the battery(ies) inside the affected pocket(s) (if
present). If a pocket fault occurs:
1 Remove the battery(ies) (if any) from the affected pocket(s).
2 Record the alarm code for the defective pocket, if possible:
a Press and hold the number button for this pocket to display the alarm
code on the screen. Note: The pocket alarm code will be one letter
followed by four numbers. Alarm codes related to pocket problems,
begin with the letter “S.”
b Record the alarm code for this pocket (e.g., write it on a piece of
paper), check its accuracy, and save the code for future reference, if
needed.
3 Call your VAD Coordinator or hospital contact person for help. Note: The
VAD Coordinator or hospital contact person may ask for the alarm code.
Note: Do not use the pocket until it is repaired or until the UBC is replaced. You
can continue to use the other pockets.
Detecting Faults with the Entire Unit
If the UBC detects a fault with the entire charger, all four red lights will come on
and all charging and/or calibrating for any inserted batteries will stop. If a fault
occurs for the entire unit:
1 Remove all batteries from all pockets.
2 Record the alarm code for the fault condition, if possible:
a Press and hold number button for any one of pockets to display the
alarm on the screen. Note: The pocket alarm code will be one letter
followed by four numbers. Alarm codes related to the entire unit,
begin with the letter “S.”
b Record the alarm code for this fault condition (e.g., write it on a piece
of paper), check its accuracy, and save the code for future reference, if
needed.
3 Turn off the UBC; unplug it from the electrical outlet.
4 Call your VAD Coordinator or hospital contact person. Note: The VAD
Coordinator or hospital contact person may ask for the alarm code.
HeartMate Universal Battery Charger IFU 26
Note: Do not use a damaged or defective pocket until it is repaired or until the
UBC is replaced. Until you have a safe and reliable way to recharge the batteries,
use an alternate power source to power your HeartMate system. For example, use
the HeartMate Power Module (PM) or Power Base Unit (PBU) to power the
HeartMate XVE or HeartMate II LVAS.
CAUTION! Use only the HeartMate Universal Battery Charger (UBC) to
charge HeartMate 12 volt NiMH batteries or 14 volt Li-Ion batteries. Other
battery chargers may damage HeartMate batteries.
HeartMate Universal Battery Charger IFU 27
INSPECTION, CLEANING & MAINTENANCE
6.0 Routine Inspection and Cleaning
The HeartMate Universal Battery Charger (UBC) requires little preventive
maintenance. However, it should be inspected routinely for the safest and best
possible performance:
• Once a week, inspect the UBC for signs of physical damage, such as dents,
chips, or cracks. Do NOT use the charger if it shows signs of damage. Obtain
a replacement from your VAD Coordinator or hospital contact person.
• Once a week, inspect the power cord used to connect the UBC to an electrical
outlet. Make sure the cord is not kinked, split, cut, cracked, or frayed. Do not
use the cord if it shows signs of damage. Obtain a replacement from your
VAD Coordinator or hospital contact person.
• Once a month, UNPLUG the UBC and then clean the metal contacts inside
all four charging pockets with a lint-free cloth or swab that has been
moistened (not dripping) with rubbing alcohol. Note: Allow the alcohol to dry
before inserting batteries into pockets. When re-powering the UBC, make sure
that the self-test is completed as described in Section 2.1, Step 7.
• Periodically and as needed, UNPLUG the charger and clean the exterior
surfaces using a clean, damp (not wet) cloth. You may use a mild, nonabrasive cleaner if necessary. Do NOT immerse the UBC in water or liquid.
• At least once a year, bring the HeartMate UBC to an authorized service
technician for a thorough safety inspection and cleaning that includes (but
need not be limited to) the following:
⋅ Functional test of device
⋅ Cleaning and inspection of all internal components
Note: Your VAD Coordinator or hospital contact person can coordinate annual
UBC inspection/maintenance for you.
CAUTION! Service and maintenance of the HeartMate Universal
Battery Charger should be performed only by service personnel who
are trained and authorized by Thoratec Corporation.
HeartMate Universal Battery Charger IFU 28
7.0 Product Disposal
Dispose of (or recycle) used or damaged UBCs in compliance with all applicable
local, state, and federal laws and regulations. Talk with your VAD Coordinator or
hospital contact person for guidance, if needed.
8.0 Testing and Classification
The HeartMate UBC complies with the following safety standards:
• IEC 60601-1:1998, 2nd Edition, A1:1991, A2:1995.
• UL 60601-1, 1st Edition, 2006-04-26 (included National Differences for USA)
• EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996
• CAN/CSA C22.2 No.601.1-M90 (R1997), CAN/CSA C22.2 No.601.1S1-94,
and CAN/CSA C22.2 No.601.1B-98 (National Difference for Canada)
The HeartMate UBC has been tested and found to comply with the limits for
medical devices to the IEC 60601-1-2:2004. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation. The UBC is an unintentional radiator of radio frequency energy and,
if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If the HeartMate UBC does
cause harmful interference to other devices, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which
the other device(s) are connected.
• Consult Thoratec Technical Service for assistance.
HeartMate Universal Battery Charger IFU 29
Declaration Concerning General Safety Standards
Type Degree of Protection
Mode of Operation Continuous
Type of protection against electrical
shock
Degree of protection against electric
shock
Degree of safety of application in
the presence of a flammable
anesthetic mixture with air or with
oxygen or nitrous oxide.
Degree of protection against
harmful ingress of water
Class I (grounded)
No Applied Part
Equipment not suitable for use in
the presence of a flammable
anesthetic mixture with air or with
oxygen or nitrous oxide.
IPX0
Medical Electric Equipment
with respect to shock, fire,
mechanical and other specified
hazards only in accordance with
UL 60601-1 and CAN/CSA C22.2
No.601.1-M90 (R1997), CAN/CSA C22.2
No.601.1S1-94, and CAN/CSA C22.2
No.601.1B-98 (National Difference for Canada)
For more information on Compliance and EMC testing, please refer to the following
LVAS System Manuals:
• HeartMate II LVAS Operating Manual (document #103884)
• HeartMate XVE LVAS Operating Manual (document #103887)
Manuals for HeartMate power accessories include:
• HeartMate 12 Volt NiMH Battery Instructions for Use (IFU) (document # 103769)
• HeartMate 14 Volt Li-Ion Battery IFU (document # 103770)
• HeartMate Universal Battery Charger IFU (document # 103771)
• HeartMate Power Module IFU (document # 103772)
HeartMate Universal Battery Charger IFU 30
APPENDIX 1
TECHNICAL SPECIFICATIONS
HeartMate Universal Battery Charger (UBC) Catalog #1440
(North America)
ACTIVE FUNCTIONS Four pocket simultaneous battery charging for
HeartMate 12 volt NiMH batteries (part no. 102474)
and 14 volt Li-Ion batteries (part no. 102515).
Battery Chemistry: 12 volt batteries are nickel metal
hydride (NiMH) ; 14 volt batteries are lithium ion (LiIon).
Battery calibration and diagnostics.
MONITORING FUNCTIONS Battery fault monitoring (with alarm codes)
Battery charger fault monitoring (with alarm codes)
POWER REQUIREMENTS 100-240 VAC, 50-60 Hz, 3A (maximum)
Fuse Rating - T5A, 250 V
DIMENSIONS
Length 370mm
(14.5")
Width 216mm
(8.5”)
Height 227mm
(9")
WEIGHT 3.6 Kg
(8 lbs)
OPERATING ENVIRONMENT
Acceptable
Equipment
Universal Battery Charger
Temperature Range
0°C to 40°C
(32°F to 104°F)
Relative
Humidity
30 to 75%
Air Pressure
525 to 795 mmHg
700 to 1060 hPA
(20.7 to
31.3 inHg)
HeartMate Universal Battery Charger IFU 31
STORAGE AND TRANSPORT ENVIRONMENT
Acceptable
Equipment
Temperature
Range
Relative
Humidity
Air Pressure
375 to 795 mmHg
Universal Battery Charger
-20°C to 60°C
(-4°F to 140°F)
10 to 93%
500 to 1060 hPA
(14.8 to 31.3
inHg)
HeartMate Universal Battery Charger IFU 32
APPENDIX 2
Description of English Text and Graphic Symbols
Appearing on the HeartMate UBC Display Panel
Meaning
Ready
Battery Charge Status
Battery Information
rd
(3
screen)
Charge Complete
Request Calibration
Accept Calibration
Change Graphics Mode
to English
Change Graphics Mode
to Symbols
English Mode
(on-screen message)
HeartMate
CHARGER
X: █ █ █ █ █
# = X
X: mAh = XXXX
READY
X: █ █ █ █ █
CALIBRATE?
PRESS X
PROGRESS X:
CALIBRATING
ENGLISH
OK ▼
GRAPHICS
OK ▼
Graphics Mode
(on-screen message)
HeartMate
CHARGER
# = X
X: mAh = XXXX
ENGLISH
OK ▼
GRAPHICS
OK ▼
Battery Fault CALL SERVICE
Charger Fault CALL SERVICE
Battery Fault
(Button Push)
Charger or Pocket Fault
(Button Push)
CALL SERVICE
BXXXX
CALL SERVICE
SXXXX
HeartMate Universal Battery Charger IFU 33
APPENDIX 3
Graphic Symbols Found on HeartMate UBC
Labels and Labeling
Manufacturer
Serial Number
Catalog Number
Attention, consult accompanying documents before use
Caution: US federal law restricts this device to sale by or on
the order of a physician.
Operating Environment (temperature)
HeartMate Universal Battery Charger IFU 34
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