Aqua Free Germlyser AM 사용 지침 - 페이지 2
{카테고리_이름} Aqua Free Germlyser AM에 대한 사용 지침을 온라인으로 검색하거나 PDF를 다운로드하세요. Aqua Free Germlyser AM 2 페이지.
1.3 Scope of delivery
• Germlyser
®
AM
• 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
®
SN
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
AM
- 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