Aqua Free Germlyser AM User manual

Instructions for use
www.aqua-free.com
7 Maintenance and cleaning
TheGermlyser®AM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®AM,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).
GEBR-ANW-AM-GB-08/2021-V004
Germlyser®AM
Headquarters:
Aqua free GmbH
Winsbergring31
22525Hamburg
Germany
Phone: +49(0)40-46899990
Fax:  +49(0)40-46899999
[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: +44(0)1484483045
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.
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 Product
1.1Productdescription
The Germlyser® AM is a -marked, point-of-use, sterile tap filter for use as a mobile shower in ICU
wards 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113mmxØ43mm
7logstepsBrev. dim.
0.2µm
Retention*:
Poresize:
Operatingtime: Dependingontheapplication
Chlorineresistance**:<10ppm
Minimumowrate: Adjustableupto5l/min.
at5bar,at25°C
Max.operatingpressure***: 5barat50°C
Max.operatingtemperature: 60°C(at70°C<10min.
overoperatingtime)
Connection: Quick-releasecoupling
**Continuousdosageof≤10ppmoveroperatingtime;short-term(1h)highdosage(400,000ppm)
forchemicaldisinfection.
***TheGermlyser®AMisnotsuitableforconnectiontolow-pressuresystems(e.g.boilers).
* Measured in accordance with the international ASTM F838-15a standard - Standard Test Method for
Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

- Leavethelterinitspackagingandinsertitintothe
quick-releasecouplingwithaslightturningmovement
untilthelteraudiblyengages
- Removepackagingandalignthelter
- Openthewatertaptocheckforleaksandwaterow
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
- Thislterisdesignedformobileshowersforsingle
orpatient-relateduse
- Donotsubmergethelterintheshowerwater
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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®AM
- Spraypistolwithintegratedquick-releasecouplingandhoseof2meterslength
ItemNo:100233
- Extensionhosewithintegratedquick-releasecoupling,1.5meterslength
ItemNo:100363
4 Preparation of commissioning and use of product
Please disinfect your hands and wear disposable gloves during lter installation
4.1FilterinstallationofthespraypistolSP10
- Openthepackagingontheadaptersideofthelter
-Wet the seal with a commercial disinfectant
(foreasyandsafeinstallation)
Change:
11/11/2016
1.4Reprocessing
TheGermlyser®AM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, Winsbergring 31, DE-22525 Hamburg:
ThemanufacturerdeclaresfortheproductGermlyser®AM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®AM
• Transportbox
• Cabletieforproductreturnandboxfastener
• Ziplockbagforusedlter
• Informationmaterial,stickerforlterreplacement