Device Recall Maquet 의 리콜

Class 1 exempt Device Listing #D122038  Tegris Base System 1703.01X0 OR TAblet Module 1703.71A0  Secondary 19" touchscreen - part number 1707.05A0  The above product is affected only when used in combination with   Tegris base system 1703.01X0 OR Table Control 1703.71A0

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.

TEGRIS system || Four labels of the Tegris System include: || Emergency button (1703.72) || MAQUET GmbH & Co. KG || Kehler-Strabe 31 || Baden-Wuerttemberg || 76437 Rastatt, Germany || Touch screen (elo) || Elo TouchSystems 301 Constitution Drive || Menlo Park, CA 94025 || www.elotouch.com || Manufacturer: Tyco Electronics || Brand Name: Elo Touch Systems || Made in China || Tegris system (1703.01) || MAQUET GmbH & Co. KG || Kehler Strabe 31 || 76437 Rastatt, Germany || OR Table Module (1703.71) || MAQUET GmbH & Co. KG || Kehler Strabe 31 || Baden-Wuerttemberg || 76437 Rastatt, Germany || Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts