Thoratec HEARTMATE ICU COVER Instructions For Use Manual Download Page 1

Thoratec Corporation

H

EART

M

ATE®

 ICU C

OVER

 

 

I

NSTRUCTIONS

 

FOR

 U

SE

Thoratec Corporation continually strives to provide the highest quality of products for mechanical 
circulatory support. Specifications may change without notice. HeartMate, Thoratec, and the 
Thoratec logo are registered trademarks, and HeartMate 3 is a trademark of Thoratec 
Corporation.

 

 

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

©2017 Thoratec Corporation. 

Document: 10004064.B

Publication Date: 10/2017

Summary of Contents for HEARTMATE ICU COVER

Page 1: ...echanical circulatory support Specifications may change without notice HeartMate Thoratec and the Thoratec logo are registered trademarks and HeartMate 3 is a trademark of Thoratec Corporation Caution...

Page 2: ......

Page 3: ...ilable for independent learning For assistance in setting up using or maintaining the HeartMate ICU Cover or to report any unexpected operation contact Thoratec Corporation See Thoratec contact inform...

Page 4: ...ler in the ICU Cover showing the Clip and Usage Tag Clip Usage Tag Figure 1 System Controller in ICU Cover Front View Figure 2 displays the back view of the System Controller in the ICU Cover showing...

Page 5: ...after all seven numbers have been marked or if it becomes soiled or damaged 2 0 Indications for Use The ICU Cover is indicated for hospital use by post operative patients for example in an ICU settin...

Page 6: ...Do not place it underneath the patient or under a blanket Do not use when the patient is ambulatory or at home No modification of the ICU Cover is allowed Do not use the ICU Cover with any other acce...

Page 7: ...t the exit site Pulling on or moving the driveline can keep the exit site from healing or damage an already healed exit site Exit site trauma or tissue damage can increase the patient s risk of gettin...

Page 8: ...nstallation and Marking of Usage Tag 1 Insert the System Controller into the ICU Cover immediately after the Backup Battery is installed or the patient is moved into ICU 2 Ensure that the System Contr...

Page 9: ...Cover to hold the System Controller in place Figure 2 VELCRO Strap Figure 2 Close the VELCRO Strap of the ICU Cover 4 If needed re thread the strap on the back of the ICU Cover depending on the orient...

Page 10: ...uch as the patient s gown and ensure that it does not come in direct skin contact or pull on the Driveline Complete the following steps to clip the ICU Cover a Open the Clip by flipping the lever arm...

Page 11: ...ached Figure 6 Securing the Clip 6 Ensure that the System Controller with the ICU Cover installed Is not kept covered by an insulating material such as a blanket Will not come in prolonged direct cont...

Page 12: ...all the numbers on the Usage Tag are marked or when the ICU Cover is soiled or damaged 2 Remove the VELCRO strap 3 Remove the ICU Cover off of the System Controller by pulling the Usage Tag while hold...

Page 13: ...HeartMate ICU Cover Instructions for Use 11...

Page 14: ...symbols that are used on the Thoratec components accessories or packaging SYMBOL DESCRIPTION Manufacturer Date of manufacture Catalogue number Batch Code Serial number Temperature Limitation Follow I...

Page 15: ...horatec system components follow the operating guidelines listed here Operating system components outside of the environmental parameters listed below may affect device operation or result in equipmen...

Page 16: ...HeartMate ICU Cover 14 Instructions for Use...

Page 17: ......

Page 18: ...Drive Pleasanton CA 94588 USA Tel 925 847 8600 Fax 925 847 8574 Internet www thoratec com Thoratec Corporation 6035 Stoneridge Drive Pleasanton CA 94588 Tel 925 847 8600 Toll Free 800 528 2577 Fax 925...

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