Aqua Free Germlyser D User manual

www.aqua-free.com
Instructions for use
1 Product
1.1 Product description
The Germlyser® D is a -marked, point-of-use sterile shower 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.
1.1.1 Designated purpose
The hollow fibre membrane integrated in the Germlyser® D sterile filter guarantees retention of all
waterborne bacteria Pseudomonas aeruginosa or legionella. Users can come into contact with
waterborne bacteria during showering or when cleaning a shower unit and this leaves them open to the
threat of infection. Using the Germlyser® D sterile filter reliably prevents contact with these pathogens and
therefore protect against infetion.
7 Maintenance and cleaning
The Germlyser® D 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® D, 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 of the package, the product should be
returned to Aqua free, along with the Defect Report form delivered with the product (form downloads at the
service page under 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.
GEBR-ANW-D-GB-08/2021-V005
Germlyser®D
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
1.2 Technical data
Size:
Retention*:
Pore size:
Operating time**:
L 206 mm x Ø 43 mm
7 log steps Brev. dim.
0.2 µm
up to 2 months
Chlorine resistance***: ≤10 ppm
Minimum ow rate: 12 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
** Depending on water quality
*** Continuous dosage of ≤ 10 ppm over operating time; short-term (1h) high dosage (400,000 ppm)
for chemical disinfection.
**** The Germlyser®D is not suitable for connection to low-pressure systems (e.g. boilers).
Aqua free Solutions Ltd.
The Media Centre
7 Northumberland Street
Hudderseld, HD1 1RL, Great Britain
E-Mail: [email protected]
Phone: [phone]
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 room temperature.
Certication:
Headquarters:
Aqua free GmbH
Winsbergring 31
22525 Hamburg
Germany
Phone: [phone]
Fax: [phone]
[email protected]
www.aqua-free.com
* Measured in accordance with the international ASTM F838-15a standard - Standard Test Method for
Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

1.3 Scope of delivery
• Germlyser®D
• 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®D 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.
1.4 Warning notes
Check the packaging for damage prior to use. After unpacking / Prior to rst-time use of the
Germlyser® D, the lter must be examined to ensure that it is undamaged.
The Germlyser®D may only be handled by instructed/trained persons.
Aqua free GmbH does not accept any warranty for use of the Germlyser® D after the specied service
life of up to 2 months. The operator is responsible for its use.
The Germlyser®D housing must not be opened or altered.
4.2 Filter installation
Please disinfect your hands and put on disposable gloves
before lter installation
- Open the packaging on the adapter side of the lter
-Wet the o-ring with a commercial disinfectant
(for easier and safer installation)
- Leave the lter in its packaging and insert it into the
quick-release coupling with a slight turning movement until
the lter audibly engages
- Align lter and remove packaging
-Open the water supply to test the ow and check for leakage
4.3 Filter replacement documentation
- Note the date of the next lter replacement on the sticker
and place it on the lter in an easily visible position –
but not on the barcode.
4.4 Handling recommendations when used for wound rinsing
- Rinse the lter after use.
- Dry the spray head and housing and disinfect by wiping with
standard alcohol disinfectant wipes.
- Store the lter in a hygienic environment until it is next used for rinsing wounds.
- Rinse the lter before re-using for rinsing wounds.
Note: To further reduce the potential for infection it is recommended that each
lter is dedicated to one individual patient.
5 Removal of used lter / lter change
Please disinfect your hands and put on disposable gloves
before removing lter
- Place the zip lock bag over the lter, loosen the adapter
and pull off the lter
- Place the lter in the provided transport box
- The transport box must be equipped with protective foil
for safe transport
- Close transport box with cable ties for dispatch
- Install a new lter (see point 4)
6 Accessories for Germlyser®D
- Quick-release coupling (including seal) with G½" female thread
Item No.: 100573
- Quick-release coupling (including seal) with G½" male thread
Item No.: 100300
- Bacillol Tissues, Disinfecting wipes in dispenser
Item No.: 100423
4 Preparation for commissioning and use of product
4.1 Installation of quick-release coupling
- Remove the shower head
- Install the quick-release coupling (including water stop)
Check the adapter for leakage by opening the water tap
without installing the lter!
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:
For the Class I medical product Germlyser®D the manufacturer declares conformity with the basic
requirements of Annex I of council directive 93/42 EEC and its amendment 2007/47/EC as required
by Annex IX of directive 93/42 EEC on medical devices.
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