Aqua Free Germlyser W User manual

www.aqua-free.com
Instructions for use
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
7 Maintenance and cleaning
The Germlyser® W 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® W, 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
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).
Please note: Aqua free operates its own replacement service, which can be used by facilities with 25 or
more lterpoints of use.
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).
GEBR-ANW-W-GB-05/2021-V003
Germlyser®W
The Germlyser® W is a -marked, point-of-use sterile shower filter for use in birthing pools and burn baths
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 206 mm x Ø 43 mm
Retention: 7 log steps Brev. dim.
Pore size: 0.2 µm
Operating time*: 4 weeks
Chlorine resistance**: ≤10 ppm
Flow rate: 20 l/min at 5 bar, at 25°C
Max. operating pressure***: 5 bar at 60°C
Max. operating temperature: 60°C (at 70°C < 30 min.
over operating time)
Connection: Quick-release coupling
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]
* 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®W is not suitable for connection to low-pressure systems (e.g. boilers).

1.3 Scope of delivery
• Germlyser®W
• Transport box
• Cable tie for product return and box fastener
• Zip lock bag for used lter
• Information material, sticker for lter replacement
1.4 Reprocessing
The Germlyser®W is a high-quality, reusable, -labelled medical device that is made available to the
4.2 Filter installation
- Open the packaging to expose the lter connector
- Leaving the lter in its packaging, insert the connector into the
quick-release coupling with a slight turning movement until the
lter engages with an audible click
- Remove packaging and align the lter
- Check the leak tightness and water ow at open water tap
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
4.4 Filter handling
- Do not submerge the lter in the bath water and do not drop it
- Avoid contamination by splashing
- After each use, wipe the lter outlet with a surface disinfectant
- Store the lter in the intended holder
5 Removal of used lter / lter change
Please disinfect your hands and wear disposable
gloves during lter installation
- Place a zip lock bag over the lter, loosen the coupling
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)
6 Accessories for Germlyser®W
- Quick-release coupling with G½'' male thread
Item No.: 100307
- Inlet quick-release coupling M28 male thread and 90° angle for tub-faucets
Item No.: 100308
- Further accessories on request
4 Preparation of commissioning and use of product
Please disinfect your hands and wear disposable
gloves during lter installation
4.1 Installation of adapter (at initial installation or maintenance)
- The lter can be connected via a exible shower
hose or a xed water outlet
- Install the suitable quick-release coupling
- Check the tightness of installation
Change:
11/11/2016
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 certified according to DIN EN ISO 13485.
The Germlyser® filters 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® W 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