Aqua Free Germlyser D Gebrauchsanweisung - Seite 2

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1.3 Scope of delivery

• Germlyser

• Transport box

• Cable tie for product return and box fastener

• Zip lock bag for used filter

• Information material, sticker for filter replacement

1.4 Reprocessing

The Germlyser

D is a high-quality, reusable

customer at a fixed rental rate. Reprocessing is carried out exclusively by Aqua free.

1.4 Warning notes

Check the packaging for damage prior to use. After unpacking / Prior to first-time use of the

D, the filter must be examined to ensure that it is undamaged.

Germlyser

The Germlyser

D may only be handled by instructed/trained persons.

Aqua free GmbH does not accept any warranty for use of the Germlyser

life of up to 2 months. The operator is responsible for its use.

The Germlyser

D housing must not be opened or altered.

2 Certificates / Declaration of conformity

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

filters are

-labelled medical devices.

The Germlyser

Extract from the declaration of conformity

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

For the Class I medical product Germlyser

D the manufacturer declares conformity with the basic

requirements of Annex I of council directive 93/42 EEC and its amendment 2007/47/EC as required

by Annex IX of directive 93/42 EEC on medical devices.

3 Labelling

Manufacturer label

D/GB

Product information material

Do not use if package

is damaged

4 Preparation for commissioning and use of product

4.1 Installation of quick-release coupling

- Remove the shower head

- Install the quick-release coupling (including water stop)

Check the adapter for leakage by opening the water tap

without installing the filter!

-labelled medical device that is made available to the

D after the specified service

Individual product label

Medical device label

Non-sterile

NON

STERILE

4.2 Filter installation

Please disinfect your hands and put on disposable gloves

before filter installation

- Open the packaging on the adapter side of the filter

- Wet the o-ring with a commercial disinfectant

(for easier and safer installation)

- Leave the filter in its packaging and insert it into the

quick-release coupling with a slight turning movement until

the filter audibly engages

- Align filter and remove packaging

- Open the water supply to test the flow and check for leakage

4.3 Filter replacement documentation

- Note the date of the next filter replacement on the sticker

and place it on the filter in an easily visible position –

but not on the barcode.

4.4 Handling recommendations when used for wound rinsing

- Rinse the filter after use.

- Dry the spray head and housing and disinfect by wiping with

standard alcohol disinfectant wipes.

- Store the filter in a hygienic environment until it is next used for rinsing wounds.

- Rinse the filter before re-using for rinsing wounds.

Note: To further reduce the potential for infection it is recommended that each

filter is dedicated to one individual patient.

5 Removal of used filter / filter change

Please disinfect your hands and put on disposable gloves

before removing filter

- Place the zip lock bag over the filter, loosen the adapter

and pull off the filter

- Place the filter in the provided transport box

- The transport box must be equipped with protective foil

for safe transport

- Close transport box with cable ties for dispatch

- Install a new filter (see point 4)

6 Accessories for Germlyser

- Quick-release coupling (including seal) with G½" female thread

Item No.: 100573

- Quick-release coupling (including seal) with G½" male thread

Item No.: 100300

- Bacillol Tissues, Disinfecting wipes in dispenser

Item No.: 100423