28
EN
1.1 NOTES ON THE INSTRUCTIONS FOR USE
These instructions for use contain important information as to how you can operate TRACHEOPORT
®
JUNIOR
safely, properly and effectively. It helps avoid hazards and reduce repair costs and outage times, thus enhancing,
amongst other features, the reliability and prolonging the service life of the device. They not only serve for
briefing persons who operate the device, but are also intended to be used as reference.
The instructions for use must always be kept available close to the device.
Technically correct application ensures the operational safety and the functionality of TRACHEOPORT
®
JUNIOR
and is therefore indispensable, besides cleaning performed on a regular basis.
Reparaturarbeiten und professionelle Aufbereitungen für den Wiedereinsatz dürfen nur durch den Hersteller
oder einen autorisierten Fachbetrieb durchgeführt werden. By using original spare parts, you have the warranty
that the operational safety, availability for use as well as the value of your TRACHEOPORT
®
JUNIOR will be
preserved.
•
The product TRACHEOPORT
®
JUNIOR bears the CE marking in accordance with EC Directive 93/42/EEC
for medical devices and meets the basic requirements of Annex I of this directive.
•
The quality management system applied at Andreas Fahl Medizintechnik-Vertrieb GmbH is certified according
to the international standards DIN EN ISO 13485 .
•
Read Section 2.0 „Safety information“ before taking the device into operation for the first time in order to avoid
possible hazardous situations.
•
These instructions for use correspond to the current state of the technical safety standards at the time of going
to print.
•
Reprinting – including in excerpts – is subject to the written consent of Andreas Fahl Medizintechnik-Vertrieb
GmbH.
•
Subject to alterations. Errors excepted.
These instructions for use are valid for the following device:
TRACHEOPORT
®
JUNIOR (REF 63800)
in connection with the accessory parts specified in Section 9.0, as well as for all devices of identical construction with special
voltage.
Please keep this document for later use!
1.0 INTRODUCTION
§