0344

ANTIMICROBIAL SOLUTION FOR THEPREVENTION OF CIED INFECTIONS

TauroPharm GmbHAugust-Bebel-Str. 51D-97297 WaldbüttelbrunnTel.: +49 (0) 931 304 299-0 ISO 13485

0344

WWW.TAUROPACE.COM

Manufacturer:

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™. Details see instruction for use.

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 ingredi-ent.

Safety:No safety issues are to be expected from unintended exposure of the implantation pocket (e.g. rinsing). Nevertheless, TauroPace™ coming into contact with the implantation pocket needs to be removed before suture.

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 con� gurations are available for TauroPace™: 10 x 100 mL vials; 10 x 250 mL vials.

85108/47/19This information does not replace the instruction for use.