Aqua Free Germlyser IL 1500 User manual

www.aqua-free.com
Instructions for use
1 Product
1.1 Product description
6 Accesories for Germlyser®IL 1500
- Ø 8mm Connection hoses (red/blue)
• Quick release adapter
• Isolation valve
• Locking ring
Common accessories are to be found in the current accessories
catalog or at www.aqua-free.com.
7 Maintenance and cleaning
The Germlyser® IL 1500 requires no maintenance within the specied operating time. The outside of the
lter can be treated by common surface disinfectants. Replace the connecting hoses, if necessary, for
example in case of leaks. For longer periods of non-use, it is recommended to close the water supply.
In the case of a deviation from the specications or a damage of the packaging, the product should be
returned to Aqua free, along with a Defect Report. The Defect Report form is available to download from
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.
GEBR-ANW-IL1500-GB-08/2021-V004
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.
Germlyser®IL 1500
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]
The Germlyser® IL1500 filter is a -marked, inline, sterile filters for use in cold water inlets of medical
equipment 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
Size: L 122 mm x Ø 43 mm
Retention*: 7 log steps Brev. dim.
Pore size: 0.2 µm
Operating time**: Depending on the application
<10 ppm
Chlorine resistance***:
Minimum flow rate: 6 l/min at 5 bar, at 25°C
Maximum operating pressure: 5 bar
Connection: Quick-release coupling
**The operating time depends on application conditions like water quantity and water quality.
*** Continuous dosage of ≤ 10 ppm over operating time; short-term (1h) high dosage (400,000 ppm)
for chemical disinfection.
* Measured in accordance with the international ASTM F838-15a standard - Standard Test Method for
Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

- Install connection hoses as follows:
○ Push the red hose or existing ø8mm hose/pipe completely
into the quick release adapter (lter inlet side)
○ Push the blue hose completely into the quick release adapter
(lter outlet side)
○ Pull the pipes to check the connection
4.2 Filter installation
- Disinfect ttings with an alcoholic surface disinfectant
- Open the packaging and remove the lter
- Connect the lter inlet to the red hose or existing ø8mm hose/pipe
- Similarly, connect the blue hose into the lter outlet side
- Pull the pipes to check the connection
-Open water supply, check tightness of the connections
and 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
Turn off general water supply before installation
The water in the pipes must not be under pressure
- Disconnect the blue hose from the lter
(Caution: Residual water can escape).
The connection is released by pressing
the retaining element against
the connector.
- Place zip lock bag over the lter
- Disconnect the red lter inlet hose (as above)
(Caution: Residual water can escape)
- Hoses remain attached to the adapters
- 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 4.2)
4 Preparation of commissioning and use of product
Please disinfect your hands and wear disposable gloves during lter installation
Turn off general water supply before installation
4.1 Adapter and hose installation
For initial installation or maintenance – if appropriate connection options (hose / pipe ø 8 mm) are not
available
- Open the water line to the point where the lter is to be installed. Note: Residual water can escape.
- Install the suitable quick-release coupling on counterparts in the pipe system. Note: Pay attention the
correct seating of the seal.
- Cut back the connecting hoses to the appropriate length, keeping blue hose as short as possible
1.4 Reprocessing
The Germlyser® IL 1500 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® IL 1500 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
1.3 Scope of delivery
• Germlyser®IL 1500
• Transport box
• Cable tie for product return and box fastener
• Zip lock bag for used lter
• Product information, sticker for lter replacement