Instructions For Use
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HeartMate Power Module INSTRUCTIONS FOR USE (IFU) for use with the HeartMate II® and HeartMate XVE LVAS
Corporate Headquarters
Authorized EU Representative
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
Thoratec Europe Limited Burnett House, Lakeview Court Ermine Business Park Huntingdon, Cambs PE29 6UA UK Business: Tel.: +44(0) 1480 455200 Fax: +44(0) 1480 454126 Urgent/24-Hour: +44(0) 7659 877901
Document # 103840.C 07/2010
Table of Contents WARNINGS & PRECAUTIONS Warnings Precautions
1 1 3
INTRODUCTION 1.0 Overview 2.0 Setting Up the Power Module (PM) Prior to Use 2.1 Connecting the Internal Backup Battery 2.2 Connecting the PM Power Cord and PM Patient Cable 2.3 Connecting the Display Module 2.4 Connecting the System Monitor 2.5 Setting Up the System Monitor for Use with the PM 2.6 Mounting the System Monitor onto the PM 2.7 Monitoring PM Performance and Performing a PM System Self Test
4 4 5 5 9 13 17 18 21
USING THE POWER MODULE (PM) 3.0 Tethered Operation (Overview) 3.1 Changing from PM Power to Batteries 3.2 Changing from Batteries to PM Power 4.0 Power Module (PM) Backup Power
25 25 26 29 34
RESPONDING TO ALARMS 5.0 Power Module (PM) Alarm Conditions
38 38
LIVING WITH THE POWER MODULE (PM) 6.0 Sleeping 7.0 Showering 8.0 Traveling by Car 8.1 Connecting to DC Power When Traveling by Car 8.2 Disconnecting from Automobile DC Power
41 41 41 43 44 47
HeartMate Power Module IFU i
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INSPECTION, CLEANING & MAINTENANCE 9.0 Routine Inspection 10.0 Periodic Cleaning 11.0 Routine Maintenance 12.0 Product Disposal 13.0 Testing and Classification
49 49 50 50 51 51
APPENDICES APPENDIX 1: Technical Specifications – Power Module (PM) (c/n 103868 -EU) APPENDIX 2: Graphic Symbols Found on Power Module (PM) Labels and Labeling APPENDIX 3: HeartMate II Power Change Checklist
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Warnings & Precautions Warnings •
Understanding the operating and 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 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 Power Module Instructions for Use (IFU) and the corresponding (HeartMate II or HeartMate XVE LVAS) Instructions for Use, Operating Manual, and /or Patient Handbook before attempting use.
•
Before using any HeartMate power accessories (Power Module, 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)
•
The HeartMate Power Module (PM) generates, 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 PM. Interference can be determined by unplugging the PM and seeing the affect on devices in the area. If interference is detected, attempt to correct it by FIRST SWITCHING TO BATTERY POWER and then: - Re-orienting or moving the affected device(s). - Increasing the distance between the PM and the affected device(s). - Connecting the affected device(s) to an electrical outlet different from the outlet used to power the PM. - Consulting Thoratec’s Technical Services Department for advice and assistance.
•
Connect the HeartMate PM only to properly-tested, grounded (3-prong) AC outlets that are dedicated to PM use. Do not use an adapter plug for ungrounded wall outlets or portable multiple socket outlet (power strip), or you may receive a serious electric shock or the pump may stop.
•
Do not connect the PM to electrical outlets controlled by a wall switch, or the PM may be left inoperable.
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The PM like any piece of electrically-powered life-sustaining equipment should remain continually plugged into a properly-grounded (3-prong) AC electrical outlet that is dedicated to its use, except during transport or service/maintenance. The PM’s internal battery (that provides limited backup power to the LVAD in the event of AC electrical power failure) remains charged as long as the PM is connected to AC power.
The PM contains an internal battery. When new, the internal battery provides approximately 30 minutes of emergency backup power to the HeartMate II LVAS and 45 minutes to the XVE LVAS in the event of AC electrical power interruption/failure. If the PM is used in cold conditions (32-59°F, 0-19°C), the backup battery runtime may be reduced to a minimum of 20 minutes. The PM is shipped with its internal battery disconnected. It must be connected prior to initial use. If the internal battery is not connected, the backup power source will not work. Make sure the internal battery is connected before initial use and after any time the PM is shipped for service or maintenance.
Transfer from the PM to batteries during AC electrical power failure. The PM has an internal backup battery that will power the pump while you transfer to batteries. The internal backup battery should not be used as a backup power source for the system during AC electrical power failure. The Display Module or System Monitor will not work if connected to the PM during a power failure. In addition, the PM’s battery charge status indicators will not work during AC electrical power failure.
At least one System Controller power lead must be connected to a power source (PM or batteries) at ALL times. Disconnecting both power leads at the same time will cause the pump to stop.
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 PM with other devices. This may result in potential interference between the PM and other devices.
A patient’s primary source of power during mobile operation (i.e., while not connected to AC electrical power) should be the HeartMate batteries. The use of DC power from a car’s power adapter should be temporary and for convenience only. DC power can vary from vehicle to vehicle. If a car’s DC power is inadequate to power the LVAS, the PM will alarm or switch to backup battery power. If this occurs, switch to portable battery power and discontinue the use of DC input power to the PM.
The use of DC power from an automobile power outlet is intended for convenience while traveling by car. DC power from an automobile power outlet is NOT meant to be a primary power source; its use should be temporary only. While traveling by car and using DC power, the patient should have at least one set of charged HeartMate batteries and cables in close proximity (see Section 8.0, Traveling by Car).
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The automobile engine must be ON and RUNNING BEFORE connecting the PM to its DC power outlet.
Keep the PM away from water or moisture. If the PM has contact with water/moisture, shower spray, rain/snow or wet surfaces, you may receive a serious electric shock or your PM may fail to operate properly.
The PM is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Do not use the PM in the presence of flammable anesthetic agents (e.g., nitric oxide), or an explosion may occur.
Precautions
The PM requires preventive maintenance at least once every 12 months for the best possible operation. Preventive maintenance includes (but need not be limited to): a functional test, replacing the internal battery (the internal battery is rechargeable, but has a limited life), and replacing the PM patient cable.
PM service and maintenance should be performed only by service personnel who are trained and authorized by Thoratec Corporation.
Do not clean or service the PM while it is providing power to the system.
If the System Monitor is mounted on top of the PM, do NOT attempt to lift or carry the two devices together by using the System Monitor handle. Doing so may damage the PM and/or System Monitor.
PM connectors should be kept clean and dry. Do not expose PM connectors to water, moisture, rain/snow, dirt, etc.
When connecting PM connectors, do not force together connectors without proper alignment. Forcing together misaligned connectors may damage them.
Keep the PM plugged into electrical power at all times. If the PM is without electrical power for approximately 18-36 hours, the backup battery may be damaged.
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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 Power Module Instructions for Use (IFU) and the corresponding (HeartMate II or HeartMate XVE LVAS) IFU, Operating Manual, and or Patient Handbook before attempting use.
1.0 Overview The HeartMate Power Module (PM) (Figure 1) works with either the HeartMate II or HeartMate XVE LVAS. The PM performs the following functions: •
Provide power to the LVAS during tethered operation. See Section 3.0, Tethered Operation (Overview).
•
Provide power to the Display Module or System Monitor.
•
Connect the Display Module/System Monitor to the System Controller for monitoring purposes.
•
Echoes System Controller alarms.
Figure 1 HeartMate Power Module (front view)
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2.0 Setting Up the Power Module (PM) Prior to Use Before using the Power Module (PM) to power the HeartMate II or XVE LVAS (and optional display module or system monitor, if desired) prepare the PM for use by connecting its internal battery and attaching the power cord and patient cable. 2.1
Connecting the Internal Backup Battery PMs are shipped to customers with the internal battery disconnected. After receiving the PM, a trained individual must open the PM and connect its internal battery prior to using the device. Follow these steps to connect the internal backup battery: 1
Place the PM on a flat, sturdy surface while the device is UNPLUGGED from AC electrical power and DISCONNECTED from the patient.
2
Inspect the PM for dents, chips, cracks, or other signs of damage. Do NOT use a PM that appears damaged. Obtain a replacement, if needed.
3
Use a crosshead (Phillips) screwdriver to remove the two ¼-turn screws (Figure 2). Note: The screws will remain in the screw holes once loosened.
Figure 2 Removing rear panel of PM to connect internal backup battery a) Rear Panel (note screws) b) Unscrewing rear panel
4
Open the battery compartment cover on the rear of the PM.
5
Use the crosshead (Philips) screwdriver to remove the metal bracket that is holding the internal battery in place.
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6
Remove the internal backup battery from its PM packaging.
7
Place the black battery connector over the metal contact end of the internal backup battery (Figure 3). The contacts should “snap” into place. Gently pull on the connection to make sure it is secure. Note: The PM will begin to alarm (audio and visual) indicating the unit is disconnected from input power. This alarm can be silenced by pressing the Silence Alarm button on the user panel. The alarm will clear once the PM is connected to power.
Figure 3 Attaching black battery connectors
8
Place the internal backup battery into the battery compartment, as shown in Figure 4.
Figure 4 Attaching contacts to the internal backup battery and placing the battery into its compartment
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9
Use the crosshead (Phillips) screwdriver to reattach the metal bracket. Make sure the connection is secure (Figure 5).
Figure 5 Attaching metal bracket
10
Replace the battery compartment cover (Figure 6).
Figure 6 Replacing cover
11
Use the crosshead (Phillips) screwdriver to tighten the two ¼-turn screws (Figure 7). Make sure the screws are tight and the cover is securely closed.
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Figure 7 Closing the rear panel of the PM
12
Repeat Steps 1 – 11 any time the internal backup battery is disconnected or when the PM is transported or shipped for service/ maintenance, since the battery is disconnected for shipping.
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2.2
Connecting the PM Power Cord and PM Patient Cable The HeartMate Power Module (PM) provides electrical power to either the HeartMate II or HeartMate XVE system. In addition to powering the LVAS, the PM can simultaneously power the HeartMate Display Module or System Monitor, if desired. Before being used to power the system, the PM power cord and patient cable first need to be attached. Follow these steps for connecting the PM power cord and patient cable: 1
Place the PM on a flat, sturdy surface.
2
Obtain the grey AC power cord and place the female end of the connector into the PM’s power entry module (Figure 8a)
3
Once the cord is inserted into the power entry module, lift the power cord retention clip into the locked position; insert the two ends of the clip into the holes, as shown in Figure 8b. Engaging the clip will ensure that the AC power cord does not come out accidentally (Figure 8c).
4
Plug the PM’s grey power cord into a properly-tested and grounded (3-prong) AC mans electrical outlet that is dedicated to PM use and that is not controlled by a wall 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. Obtain a Thoratec power cord set, if needed. WARNING! Connect the HeartMate Power Module (PM) only to properly-tested and grounded (3-prong) AC outlets that are dedicated to PM use. Do not use outlets that are controlled by a wall switch. Do not use an adapter plug or portable multiple socket outlet (power strip) for ungrounded wall outlets.
5
After plugging the power cord into the AC electrical outlet, observe the front panel of the PM. The green “power on” should come on (Figure 9). Note: If the light does not come on after plugging the PM into a functioning AC electrical outlet, the device may be defective. Do not use it. Obtain a replacement, if needed.
6
Wait 2-3 hours for the PM’s internal backup battery to charge before using the PM for the first time or after prolonged storage. Note: Do not use the PM until its internal backup battery is charged. This may take several hours. The green charge lamp (battery symbol) will come on when the internal backup battery is ready (see Section 4.0, Power Module (PM) Backup Power).
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a)
b)
c)
Figure 8 Connecting the AC power cord and the retention clip
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Power On (“I”) Light (front panel of PM)
Figure 9 "Power On" light on front panel of PM
6
Obtain the PM patient cable (Figure 10) from product packing.
Figure 10 Patient cable
7
Line up the red dots between the patient cable and the “ ” socket located on the side of the PM and then insert the patient cable into the “ ” socket (Figure 11). Note: The cable will click into place if fully engaged. The “click” is the sound of the locking feature engaging.
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Figure 11 Lining up red dots. Note "Heart" symbol
7
After inserting the connector snugly into the socket, check that the connection is tight. Tug gently on the strain relief portion of the connector (Figure 12). Do NOT pull on the cable!
Grasp here to check if connection is tight
Figure 12 Where to grasp connector
WARNING! Make sure that the patient cable has fully engaged the PM. If the patient cable disconnects during operation, the pump will stop.
Note: If leaving the cable connected to the PM when not in use, place the cable somewhere it will not become damaged, dirty, or wet; and place it so that it will not cause tripping or falls.
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2.3
Connecting the Display Module When connected to the Power Module (PM) and System Controller, the Display Module (Figure 13) reports data received from the System Controller through the PM. It displays information about system performance on its display panel screen. For HeartMate II patients, the following is displayed: • Current pumping mode (fixed or power saver mode) • Current pump speed in revolutions per minute (rpm) • Pulsatility index • Estimated flow in liters per minute (lpm) • Power in watts • • • •
For HeartMate XVE patients, the following is displayed: Operating mode (fixed or auto rate) Beat rate in beats per minute (bpm) Stroke volume (ml) Flow in liters per minute (lpm)
Patients at home will use the Display Module to monitor the system. Nurses, doctors and clinicians will usually use System Monitor (see Section 2.4, Connecting the System Monitor).
Figure 13 HeartMate Display Module
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Follow these steps for setting up the Display Module for use with the PM: 1
Ensure the patient cable is attached to the PM. See Section 2.2, Connecting the PM Power Cord and PM Patient Cable.
2
Ensure that the PM is plugged into a properly-tested and grounded (3-prong) AC electrical outlet that is dedicated to PM use and that is not controlled by a wall switch. Do not use an adapter plug for ungrounded wall outlets or multiple socket outlet (power strip) for ungrounded wall outlets, or you may receive a serious electric shock.
3
Obtain the Display Module cable adapter (Figure 14) from product packaging.
Figure 14 Display Module cable adapter
4
Insert the male end of the adapter into the female end of the data cable receptacle of the Display Module. Firmly press together the connectors to ensure a tight connection (Figure 15).
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Figure 15 Display Module adapter cable attached to Display Module
5
Tighten the two thumb screws on the adapter connector to secure the connection.
6
Align the grooves between the adapter connector and the “ socket found on the side of the PM (Figure 16); insert the connector into the “ ” socket.
”
Figure 16 Inserting round adapter connector into PM socket (close up)
Note: The PM (with its round receptacle for the Display Module/System Monitor interface) replaces many of the features the Power Base Unit (PBU). You will need an adapter (described above) to connect the Display Module to the PM (see Steps 3 – 6). Contact Thoratec Corporation for an adapter, if needed.
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7
Reference the Display Module screen. If the patient is connected to the PM and System Controller, the following should immediately appear once the cable is successfully connected (otherwise, the screen remains blank): For HeartMate II, the Display Shows:
For HeartMate XVE, the Display Shows:
Current pumping mode (i.e., fixed or power saver mode) Current pump speed, in revolutions per minute (RPM) Pulsatility index (PI) Estimated flow in liters per minute (LPM) Power in watts (W)
Operating Mode (i.e., fixed rate or auto rate) Beat rate in beats per minute (BPM) Stroke volume (ml) Flow in liters per minute (LPM)
If the patient is connected to the PM and the System Controller and the screen appears as described above, the Display Module is functioning properly and ready for use with the PM.
OR 7
If the patient is connected to the PM and System Controller and the screen does not appear as described, check the following: • • •
8
The patient cable is fully inserted into the “ ” socket on the side of the PM. The Display Module adapter cable is fully inserted into the “ ” socket on the side of the PM The System Controller power leads are properly connected (white-to-white and black-to-black).
If the screen still does not appear, contact Thoratec Corporation for assistance.
Note: At any time, if an alarm condition arises, an alarm message will immediately replace performance data appearing on the display module screen.
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2.4
Connecting the System Monitor When connected to the PM, the System Monitor (Figure 17) reports data from the System Controller through the PM. Like the Display Module, the System Monitor displays information about system performance, including current control mode (i.e., “fixed”), pump flow, pump speed, and overall operational status. In addition to displaying performance data, the System Monitor also enables clinicians to control system operation using touch-screen prompts/messages. Typically, the System Monitor is used in clinical settings. Patients at home will use the Display Module to monitor the system (see Section 2.3, Connecting the Display Module).
Figure 17 System Monitor mounted atop PM
System Monitor Features and Clinical Applications The System Monitor’s touch-screen feature permits clinicians to: Change LVAS operating parameters (i.e., the fixed speed and/or fixed rate set points) Change the system operating mode ( for XVE only) Access screen that displays additional information on performance and alarm status Save LVAD motor waveforms and data records to a memory card for review, trending, and analysis (see the HeartMate II LVAS Operating Manual or the HeartMate XVE LVAS Operating Manual).
HeartMate Power Module IFU 17