Thoratec HeartMate Universal Instructions For Use Manual Download Page 1

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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

Summary of Contents for HeartMate Universal

Page 1: ...te12 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 US...

Page 2: ......

Page 3: ...ttery 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 Rela...

Page 4: ......

Page 5: ...ng 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...

Page 6: ...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 a...

Page 7: ...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...

Page 8: ...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 Perfo...

Page 9: ...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 N...

Page 10: ...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 s...

Page 11: ...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 OR 8 If the charger passes the self test HeartMate CHA...

Page 12: ...y Charger IFU 8 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 CHARG...

Page 13: ...lecting 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 befo...

Page 14: ...st 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 fo...

Page 15: ...e 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 lan...

Page 16: ...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 ch...

Page 17: ...lor Status Meaning Green Battery is charged and ready for use Yellow Battery is undergoing test or charge Yellow Blinking Battery requires calibration cycle Red Battery or charging pocket is defective...

Page 18: ...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 Heart...

Page 19: ...aced in the pocket 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...

Page 20: ...ate 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...

Page 21: ...n 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 inter...

Page 22: ...nd 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 b...

Page 23: ...ery power sample screen Figure 15 Viewing available power for the battery in pocket 1 in Graphics mode In this case the battery is approximately 90 charged Figure 16 Battery cycle count in this case 7...

Page 24: ...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 See Appendix 2 for a complete l...

Page 25: ...nded 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 f...

Page 26: ...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...

Page 27: ...HeartMate Universal Battery Charger IFU 23 Figure 19 Calibration status display in Graphics mode In this case the battery in pocket 4 is calibrating...

Page 28: ...0 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 con...

Page 29: ...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 hospit...

Page 30: ...heck 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 a...

Page 31: ...harge 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 CA...

Page 32: ...our 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...

Page 33: ...l 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 ra...

Page 34: ...gress of water 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 N...

Page 35: ...dride NiMH 14 volt batteries are lithium ion Li Ion Battery calibration and diagnostics MONITORING FUNCTIONS Battery fault monitoring with alarm codes Battery charger fault monitoring with alarm codes...

Page 36: ...harger IFU 32 STORAGE AND TRANSPORT ENVIRONMENT Equipment Acceptable Temperature Range Relative Humidity Air Pressure Universal Battery Charger 20 C to 60 C 4 F to 140 F 10 to 93 375 to 795 mmHg 500 t...

Page 37: ...ARGER Battery Charge Status X Battery Information 3rd screen X X mAh XXXX X X mAh XXXX Charge Complete READY X Request Calibration CALIBRATE PRESS X Accept Calibration PROGRESS X CALIBRATING Change Gr...

Page 38: ...mbols 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 o...

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