Aqua Free Germlyser G Kullanım Talimatları - Sayfa 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

1.4 Reprocessing

G is a high-quality, reusable

The Germlyser

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.

filters are

-labelled medical devices.

The Germlyser

Extract from the declaration of conformity

Aqua free GmbH, Winsberging 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

D/GB

Product information material

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 on spray-pistol

- Open the packaging on the adapter side of the filter

- Wet the seal with a commercial disinfectant

(for easy and safe installation)

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

quick-release coupling of the spray-pistol with a slight

turning movement until the filter audibly engages

- Align the filter and remove packaging

- Open water supply and test the leak tightness of installation and the water flow

-labelled medical device that is made available to the

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

Individual product label

Medical device label

Non-sterile

NON

STERILE

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

- Hold the filter outlet for flushing into the endoscope channel,

use appropriate purging accessories

- Do not submerge the filter into the wash water and avoid

contamination by splashing

- Daily, wipe down the filter outlet with a common

surface disinfectant

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 the 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 m length

Item No.: 100233

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

Item No.: 100363

- Purge for endoscope channels with Luer-lock

Item No.: 100360

- Purge for endoscope channels

Item No.: 100361

Change:

11/11/2016