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HeartMate ICU Cover

Instructions for Use

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.

TYPE

DETAILS

Acceptable Temperature Range

-4°F to 131°F
(-20°C to 55°C)

Air Pressure
mm Hg (hPA)

Not applicable

Содержание HEARTMATE ICU COVER

Страница 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...

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

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

Страница 17: ......

Страница 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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