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Thoratec HEARTMATE ICU COVER Instructions For Use Manual

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Thoratec Corporation
®
ICU C
H
M
EART
ATE
I
NSTRUCTIONS FOR
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
OVER
U
SE
Publication Date: 10/2017

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Summary of Contents for Thoratec HEARTMATE ICU COVER

  • Page 1 EART NSTRUCTIONS FOR 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.

  • Page 3: Section I: Preface

    As with all prescription medical devices, clinical procedures should be conducted under the direction of the prescribing physician. The professional staff at Thoratec regularly provides laboratory training and on site, in-service programs. Additional training materials are available for independent learning.
  • Page 4 HeartMate ICU Cover Figure 1 displays the System Controller 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 ...
  • Page 5 HeartMate ICU Cover The ICU Cover has a usage tag with numbers to help track the number of days the ICU Cover has been used. One number should be marked each day the ICU Cover is used; if desired, write the date on the usage tag.
  • Page 6 • Product and Medical Waste Disposal Dispose of the damaged or used ICU Cover according to applicable local, state, and federal regulations. For additional product disposal information, contact Thoratec Corporation for assistance. Instructions for Use...
  • Page 7 HeartMate ICU Cover 5.0 Cautions CAUTION ! • Do not attach any other objects or items to the ICU Cover. • Ensure that the System Controller with the ICU Cover is securely attached to a visible location (such as the patient’s gown).

  • Page 8: Section Iii: Instructions

    HeartMate ICU Cover Section III: Instructions 1.0 Installation 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 Controller display is visible (Figure 1).
  • Page 9 HeartMate ICU Cover ® 3. Close the ICU Cover with the VELCRO strap located on the top of the ICU Cover to hold the System Controller in place (Figure 2). ® VELCRO Strap ® VELCRO Strap of the ICU Cover Figure 2: Close the 4.
  • Page 10 HeartMate ICU Cover 5. Clip the System Controller with the ICU Cover installed to a secure visible location (such 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.
  • Page 11 HeartMate ICU Cover c. Press down on the Clip lever arm until it closes into place (Figure 6). d. Gently tug to ensure that the System Controller with the  ICU Cover is securely attached. Figure 6: Securing the Clip 6.
  • Page 12 HeartMate ICU Cover 9. The ICU Cover shall be replaced when all the numbers have been marked. 2.0 Removal 1. Replace the ICU Cover when all the numbers on the Usage Tag are marked, or when the ICU Cover is soiled or damaged.
  • Page 13 HeartMate ICU Cover Instructions for Use...

  • Page 14: Section Iv: Symbols

    HeartMate ICU Cover Section IV: Symbols This section describes the 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 Instructions for Use Do not use if package is damaged...

  • Page 15: Section V: Acceptable Operating Conditions

    HeartMate ICU Cover Section V: Acceptable Operating Conditions For safe and optimal use of Thoratec 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 equipment failure.
  • Page 16 HeartMate ICU Cover Instructions for Use...
  • Page 18 Manufactured by:  Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 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: 925-847-8574 www.thoratec.com. © 2017 Thoratec Corporation.

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