Aqua Free Germlyser A User manual

Instructions for use
www.aqua-free.com
1 Product
1.1 Product description
GEBR-ANW-A-GB-08/2021-V005
Germlyser®A
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]
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
The Germlyser® A is a -marked, point-of-use, sterile tap filter for use in high-risk areas in medical facilities
to prevent bacterial nosocomial infectious diseases caused by Pseudomonas aeruginosa, Legionella
pneumophila, Stenotrophomonas maltophilia or Staphylococcus aureus among immunosuppressed
and immunocompromised patients. To achieve this intended use, a specific combination of retention of
these bacteria in the filter membrane structure and specific measurements to prevent retrogarde
contamination with these bacteria on the filter outlet, are necessary.
1.2 Technical data
L 108 mm x Ø 43 mm
7 log steps Brev. dim.
0.2 µm
Size:
Retention*:
Pore size:
Operating time**: up to 2 months
Chlorine resistance***: <10 ppm
Minimum flow rate: 6 l/min at 5 bar, at 25°C
Max. operating pressure****: 5 bar
Max. operating temperature: 60°C (at 70°C < 10 min.
over operating time)
Connection: Quick-release coupling
** Depending on the water.
*** Continuous dosage of ≤ 10 ppm over operating time; short-term (1h) high dosage (400,000 ppm)
for chemical disinfection.
**** The Germlyser®A is not suitable for connection to low-pressure systems (e.g. boilers).
9 Returning
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).
8 Storage
The Germlyser® lter must be properly stored in a dry and hygienic environment at a temperature between
10 and 50°C.
6 Accesories for Germlyser®A
- Quick-release adapter for all standard faucets from Grohe, Hansa, Kludi, etc.
- Wall mounted faucets including integrated quick release adapter
- Free standing faucet including integrated quick release adapter
- Details and further accessories on request
7 Maintenance and cleaning
The Germlyser® A requires no maintenance within the specied operating time. The outside of the lter can
be treated by common surface disinfectants.
When replacing the Germlyser® A, 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 service life
of 6 to 12 month.
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).
Please note: Aqua free operates its own replacement service, which can be used by facilities with 25, or
more, lter points of use.
* Measured in accordance with the international ASTM F838-15a standard - Standard Test Method
for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

4.2 Filterinstallation
- Open the packaging on the adapter side of the lter
- Leave the lter in its packaging and insert it
(outlet aligned pointing down) into the quick-release coupling
until the lter audibly engages
- Remove packaging
- Open water supply, check the tightness of installation
as well as water ow
4.3 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.
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 adapter by gently
sliding back the plastic sheath and pull off the lter
- Place the lter into the provided transport box
- Equip transport box with protective foil for safe transport
- Close transport box with cable ties
- Install a new lter (see point 4)
When using the A-adapter chrome:
- Place zip lock bag over the lter, loosen the adapter as follows:
Insert the tool (small screwdriver, Allen wrench or similar) on
an incline into the small hole on the underside of the adapter.
Press the tool forward and the lter will be disconnected
and can be removed
- Place the lter into the provided transport box
- Equip transport box with protective foil for safe transport
- Close transport box with cable ties
4 Preparation of commissioning and use of product
Please disinfect your hands and wear disposable gloves
duringlter installation
4.1 Installation of quick-release adapter
- Install suitable quick-release adapter for wall-mounted
or free-standing faucet
- Check tightness of the installation
3 Labelling
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, Winsbergring 31, DE-22525 Hamburg:
The manufacturer declares for the product Germlyser® A 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.
1.4 Reprocessing
The Germlyser® A 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.
Manufacturer label
D/GB
Product information material
SN
Individual product label
Medical device label
Non-sterileDo not use if package
is damaged NON
STERILE
1.3 Scope of delivery
• Germlyser®A
• Transport box
• Cable tie for product return and box fastener
• Zip lock bag for used lter
• Information material, sticker for lter replacement