Aqua Free Germlyser AM Instructions For Use - Page 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

AM is a high-quality, reusable -labelled medical device that is made available to the

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

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

Do not use if package

is damaged

4 Preparation of commissioning and use of product

Please disinfect your hands and wear disposable gloves during filter installation

4.1 Filter installation of the spray pistol SP 10

- Open the packaging on the adapter side of the filter

- Wet the seal with a commercial disinfectant

(for easy and safe installation)

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

Individual product label

Medical device label

Non-sterile

NON

STERILE

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

quick-release coupling with a slight turning movement

until the filter audibly engages

- Remove packaging and align the filter

- Open the water tap to check for leaks and water flow

4.2 Filter replacement documentation

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

place it on the filter in an easily visible position –

but not on the barcode

4.3 Filter handling

- This filter is designed for mobile showers for single

or patient-related use

- Do not submerge the filter in the shower water

5 Removal of used filter / filter change

Please disinfect your hands and wear disposable gloves

during filter installation

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

and pull off the filter

- Place the filter into the provided transport box

- Equip transport box with protective foil for safe transport

- Close transport box with cable ties

- Install a new filter (see point 4)

6 Accessories for Germlyser

- Spray pistol with integrated quick-release coupling and hose of 2 meters length

Item No: 100233

- Extension hose with integrated quick-release coupling, 1.5 meters length

Item No: 100363

Change:

11/11/2016