HeartMate II Universal Battery Charger Instructions For Use Rev C Oct 2010

Table of Contents WARNINGS & PRECAUTIONS Warnings Precautions

1 1 2

INTRODUCTION 1.0 Overview 2.0 Setting Up the Universal Battery Charger Prior to Use 2.1 Plugging In and Turning On the Charger 2.2 Selecting Language/Display Panel Settings

4 4 5 5 9

USING YOUR UNIVERSAL BATTERY CHARGER 3.0 Charging Batteries 3.1 Battery Charging (Overview) 3.2 Charging Batteries (Procedure) 3.3 Viewing Battery Information on the UBC Screen 4.0 Calibrating HeartMate Batteries

12 12 12 15 18 21

RESPONDING TO ADVISORY MESSAGES 5.0 Monitoring Performance 5.1 Battery-Related Advisory Messages 5.2 Charger-Related Advisory Messages

24 24 24 26

INSPECTION, CLEANING & MAINTENANCE 6.0 Routine Inspection and Cleaning 7.0 Product Disposal 8.0 Testing and Classification

28 28 29 29

APPENDICES APPENDIX 1: Technical Specifications – HeartMate Universal Battery Charger (UBC) (p/n 1440) APPENDIX 2: Description of English Text and Graphic Symbols Appearing on The UBC Display Panel APPENDIX 3: Graphic Symbols Found on HeartMate UBC Labels and Labeling

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HeartMate Universal Battery Charger IFU i

31 33 34

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 # 103841) - HeartMate Power Module IFU (document # 103840)

•

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 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 UBC. Interference can be determined by turning off/on the 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 UBC and the affected device(s). ⋅ Connecting the affected device(s) to an electrical outlet different from the outlet used to power the UBC. HeartMate Universal Battery Charger IFU 1

⋅

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 UBC with other devices. This may result in potential interference between the UBC and other devices.

•

The UBC should not be used next to other equipment or stacked on top of or with other equipment. The normal operation of the UBC must be verified if the charger is used in these configurations.

•

Connect the 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 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 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 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 UBC to charge HeartMate 12 volt NiMH batteries 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 will indicate when a battery needs to be recalibrated. Calibration can take up to 12 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).

HeartMate Universal Battery Charger IFU 2

•

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 charger before cleaning. Use a lint-free 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.

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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 rechargeable 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.

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Figure 1 HeartMate Universal Battery Charger with empty charging pockets (front view)

2.0 Setting Up the Universal Battery Charger Before Use Before using the HeartMate Universal Battery Charger (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. Dirt or objects covering the metal contacts inside the pockets may HeartMate Universal Battery Charger IFU 5

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!

7

•

Connect the HeartMate Universal Battery Charger (UBC) only to properlytested and grounded (3-prong) AC outlets. Do not use an adapter plug or portable multiple socket 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

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 on (Figure 5), and the charger will beep once. This means the HeartMate Universal Battery Charger IFU 6

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)

8

If the UBC detects a problem during the self test, an error message 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)

OR 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.

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Figure 5 Display panel during self test

Charging Pocket Lights (green, yellow, red) Display Panel Pocket Number Button (numbers 1–4 corresponds with pocket location)

Figure 6 "HeartMate CHARGER" message (default screen)

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2.2

Selecting Language/Display Panel Settings The display panel on the front of the HeartMate 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 charger 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 charger (Figure 7).

Note location of

Note location of #1 and bubuttons ttons #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.

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3

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.

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 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 charger.

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.

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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 batteries or four 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 charger 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 charger’s display panel by pressing the number button for that pocket (see Section 3.3, Viewing Battery Information on the UBC Screen). Batteries in Pockets #2 and #4

Figure 10 Batteries inserted into Universal Battery Charger pocket s #1 and #4. Note yellow lights indicate charge status of batteries (yellow = charging).

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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 charging pocket light color codes.

Figure 11 Charge status lights (green, yellow, red) for charging pockets 1 - 4

UBC Charger Pocket Light Indicators Light Color Green Yellow Yellow (Blinking) Red

Status/Meaning 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*

Table 1 Color codes for charging pocket lights

* 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 with the 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.

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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!

2

•

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.

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) means 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 OR

If the green light is on, the battery is charged and ready for use.

7 OR

If the yellow light is on, the battery is still charging.

7

If the red light is on, there is a problem with the battery and/or the charger 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

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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).

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