Aqua Free Germlyser G User manual

Instructions for use
www.aqua-free.com
1 Product
1.1 Product description
Table of contents
1 Product
2 Certicates / Declaration of conformity
3 Labelling
4 Preparation of commissioning and use of product
5 Disassembly of used lter / lter change
6 Accessories
7 Maintenance / cleaning
8 Storage
9 Return
Headquarters:
Aqua free GmbH
Winsbergring 31
22525 Hamburg
Germany
Phone: [phone]
Fax: [phone]
[email protected]
www.aqua-free.com
Aqua free Solutions Ltd.
The Media Centre
7 Northumberland Street
Hudderseld, HD1 1RL, Great Britain
E-Mail: [email protected]
Phone: [phone]
7 Maintenance and cleaning
The Germlyser® G requires no maintenance within the specied operating time. The outside of the lter
can be cleaned using common surface disinfectants.
When replacing the Germlyser® G, a small amount of unltered water will ow out. Over time, this will lead
to deposits on and in the adapters. Aqua free recommends replacement of the adapters after a period of
use every 6 to 12 months.
In the case of a deviation from the specications or a damage to the packaging, the product should be
returned to Aqua free, along with a Defect Report (form available to download on the service page of the
Aqua free website www.aqua-free.com).
GEBR-ANW-G-GB-05/2021-V003
Germlyser®G
The Germlyser® G is a -marked, point-of-use, sterile filter for manual final rinsing of endoscopes to
prevent bacterial nosocomial infectious diseases caused by Pseudomonas aeruginosa, Legionella
pneumophila, Stenotrophomonas maltophilia or Staphylococcus aureus among immunosuppressed and
immunocompromised patients.
1.2 Technical data
Size: L 77 mm x Ø 55 mm
Retention: 7 log steps Brev. dim.
Pore size: 0.2 µm
Operating time*: 4 weeks
Chlorine resistance**: <10 ppm
Flow rate: Adjustable up to 6 l/min
at 5 bar, at 25°C
Max. operating pressure***: 5 bar at 60°C
Max. operating temperature: 60°C (at 70°C < 10 min.
over operating time)
Connection: Quick-release coupling
* The operating time can be increased up to 8 weeks if sufcient hygienic measures exist and an adequate
hygiene plan is carried out. We recommend monitoring by appropriate clinical microbiological testing.
** Continuous dosage of ≤ 10 ppm over operating time; short-term (1h) high dosage (400,000 ppm)
for chemical disinfection.
*** The Germlyser®G is not suitable for connection to low-pressure systems (e.g. boilers).
8 Storage
The Germlyser® lter must be properly stored in a dry and hygienic environment at a temperature between
10 and 50°C.
9 Return
The Germlyser® reusable lters must be sent back to Aqua free within the agreed time for reprocessing
(form downloads at the service page under www.aqua-free.com).

4.2 Filter replacement documentation
- Note the date of next lter replacement on the sticker and
place it on the lter in an easily visible position –
but not on the barcode
4.3 Filter handling
- Hold the lter outlet for ushing into the endoscope channel,
use appropriate purging accessories
- Do not submerge the lter into the wash water and avoid
contamination by splashing
- Daily, wipe down the lter outlet with a common
surface disinfectant
5 Removal of used lter / lter change
Please disinfect your hands and wear disposable gloves
during lter installation
- Place zip lock bag over the lter, loosen the coupling
and pull off the lter
- Place the lter into the provided transport box
- Equip the transport box with protective foil for safe transport
- Close transport box with cable ties
- Install a new lter (see point 4)
6 Accessories for Germlyser®G
- 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
4 Preparation of commissioning and use of product
Please disinfect your hands and wear disposable gloves
during lter installation
4.1 Filter installation on spray-pistol
- Open the packaging on the adapter side of the lter
- Wet the seal with a commercial disinfectant
(for easy and safe installation)
- Leave the lter in its packaging and insert it into the
quick-release coupling of the spray-pistol with a slight
turning movement until the lter audibly engages
- Align the lter and remove packaging
- Open water supply and test the leak tightness of installation and the water ow
1.4 Reprocessing
The Germlyser® G is a high-quality, reusable -labelled medical device that is made available to the
customer at a xed rental rate. Reprocessing is carried out exclusively by Aqua free.
2 Certicates / Declaration of conformity
The company Aqua free GmbH is certied according to DIN EN ISO 13485.
The Germlyser® lters are -labelled medical devices.
Extract from the declaration of conformity
Aqua free GmbH, Winsberging 31, DE-22525 Hamburg:
The manufacturer declares for the product Germlyser® G to Annex IX of the directive 93/42 EWG on
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
SN
Individual product label
Medical device label
Non-sterileDo not use if package
is damaged NON
STERILE
Change:
11/11/2016
1.3 Scope of delivery
• Germlyser®G
• Transport box
• Cable tie for product return and box fastener
• Zip lock bag for used lter
• Information material, sticker for lter