Aqua Free Germlyser ENT Instruções de utilização - Página 2

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1.4 Reprocessing

The Germlyser

ENT is a high-quality,

-labelled single use medical device which can be disposed of

with normal recycling waste (plastic).

2 Certificates / Declaration of conformity

The company Aqua free GmbH is certified according to DIN EN ISO 13485.

The Germlyser

filters are

-labelled medical devices.

Extract from the declaration of conformity

Aqua free GmbH, Winsbergring 31, DE-22525 Hamburg:

The manufacturer declares for the product Germlyser

medical devices and medical products of Class I the conformity with the basic requirements of Annex I of

the council directive 97/42 EEC of the European communities.

3 Labelling

Manufacturer label

Product information material

D/GB

Sterilised using irradiation

4 Preparation of commissioning and use of product

Please disinfect your hands and wear disposable

gloves during filter installation

4.1 Filter installation

- Open the packaging to expose the inlet of the filter

- Leave the filter in its packaging and attach the filter inlet,

with a slight twist, to the ENT-water pistol.

- Remove packaging

- Insert the nozzle connection onto the filter outlet

with a light twist

- Use only reprocessed nozzles to avoid retrograde

contamination

ENT to Annex IX of the directive 93/42 EWG on

Individual disponsable product label

Medical device label

Do not use if package

is damaged

4.2 Filter replacement documentation

- Document the installation date and, with reference to the

specified operating time, the next change date

4.3 Cleaning & Handling after use

- Remove the nozzle after treating each patient (after each ear)

- Immediately position the water-pistol with the filter outlet pointing

downwards and rinse for some seconds with water

- Attach a new nozzle (reprocessed) to the filter outlet

- Alternatively, for storage (e.g. overnight) seal the filter outlet

with a sterile Combi-stopper closing cone

5 Removal of used filter / filter change

Please disinfect your hands and wear disposable gloves before installing the filter

- At the end of the operating time of 4 weeks, dismantle and dispose of the used filter

- Install a new filter (see point 4)

6 Accessories for Germlyser

ENT

- Combi-stopper closing cone (sterile), PU: 10 pieces

Item No.: 100132

- Short nozzle for ENT-water pistols, extra short (5 cm)

Item No.: 100351

- Splash guard for ENT nozzle, clear

Item No.: 100362