TAUROPACE™ IN CIED IMPLANTATION: “STEP BY STEP GUIDE“

TAUROPACE™ IN CIED IMPLANTATION: “STEP BY STEP GUIDE“

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ANTIMICROBIAL SOLUTION FOR THE PREVENTION OF CIED INFECTIONS

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PREPARATION OF SURGICAL SITE

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TRANSFER TAUROPACEâ„¢ TO A SINGLE USE DISH (GALLIPOT) AND SOAK A SWAB IN THE SOLUTION

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SURGICAL HANDWASH AS SUGGESTED IN WHO GUIDELINES – IN THE MEANTIME SURGICAL SITE HAS TIME TO DRY (DISINFECTING AGENT)

COVER/DRAPE THE PATIENT

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PREPARE ANATOMICAL STRUCTURES

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WIPE DOWN THE LEADS WITH THE TAUROPACE SOAKED SWAB AND KEEP THE LEADS MOIST DURING THE IMPLANTATION

NO SAFETY ISSUES ARE TO BE EXPECTED FROM TAUROPACE EXPOSURE TO THE POCKET BUT THE EXCESS TAUROPACE SHOULD BE REMOVED BEFORE INCISION CLOSURE

WIPE DOWN THE CIED WITH THE TAUROPACEâ„¢ SOAKED SWAB

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CONNECT THE LEAD(S) TO THE GENERATOR

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IF ANOTHER SURGICAL SITE NEEDS TO BE PREPARED, E.G. REMOVAL OF OLD DEVICE, THEN THE NEW DEVICE CAN BE WRAPPED IN THE TAUROPACEâ„¢ SOAKED SWAB UNTIL IT IS READY FOR IMPLANTATION

CLEAN SURGICAL SITE FROM BLOOD STAINS AND TAUROPACE™ LEFTOVERS – PLACE DEVICE IN FINAL POSITION – MOISTEN CARDIAC DEVICE WITH TAUROPACE™

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WHILE CLOSING THE INCISION, CLEAN THE INCISION AND ITS SURROUNDING AREA

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Indication: This device is intended to be used as disinfecting solution for implantation of cardiac implantable electronic devices (CIED) including its components, (e.g. leads) in any adult patient.

Description: TauroPace™ is a device preventing contamination of the CIED and its components for the process of implantation reducing the risk of microbial infectious contamination of the implantation pocket.

Application: TauroPace™ is used for the implantation process of cardiac implantable devices. Every component of the CIED has to be covered with TauroPace™.

See instructions for use for details.

Effectiveness: Due to its micro-biocidal activity, microbial contamination on the surface of cardiac implantable electronic devices (CIEDs) is eradicated and a hostile environment is created. TauroPace™ contains taurolidine as active ingredient.

Safety: No safety issues are to be expected from TauroPace™ exposure to the pocket but the excess TauroPace™ should be removed before incision closure.

Storage and shipment: Do not store TauroPace™ in a refrigerator. It must be stored and shipped at a temperature between 15°C to 25°C. Packaging configuration: The following packaging configurations are available for TauroPace™: 10 x 100 mL vials; 10 x 250 mL vials.

Hersteller:

TauroPharm GmbH August-Bebel-Str. 51 D-97297 Waldbüttelbrunn Tel.: +49 (0) 931 304 299-0

ISO 13485

Diese Produktinformation ersetzt nicht die Gebrauchsanweisung des Herstellers.

WWW.TAUROPACE.COM

88108/47/19