Aqua Free Germlyser ENT User manual

www.aqua-free.com
Instructions for use
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
7 Maintenance and cleaning
TheGermlyser®ENTrequiresnomaintenancewithinthespeciedoperatingtime.Theoutsideofthelter
canbecleanedusingcommonsurfacedisinfectants.
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).
GEBR-ANW-ENT-GB-08/2021-V005
Germlyser®ENT
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
1 Product
1.1Productdescription
1.3Scopeofdelivery
• Germlyser®ENT
• SterileCombiStoppersealingcones
• Userinstructions
The Germlyser® ENT is a -marked, inline sterile tap filter for use between ENT handles and the nozzle
attachment 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56mmxØ18mm
7logstepsBrev. dim.
0.2µm
Retention*:
Poresize:
Operatingtime: 4weeks
Chlorineresistance**:≤10ppm
Minimumowrate: 0.5l/minat5bar,at25°C
Max.operatingpressure: 5barat50°C
Max.operatingtemperature: 50°C
Connection: Luer-Lock
Sterilisationmethod: Gammairradiation
**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

1.4Reprocessing
TheGermlyser®ENTisahigh-quality, -labelledsingleusemedicaldevicewhichcanbedisposedof
withnormalrecyclingwaste(plastic).
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®ENT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.
4.2Filterreplacementdocumentation
- Documenttheinstallationdateand,withreferencetothe
speciedoperatingtime,thenextchangedate
4.3Cleaning&Handlingafteruse
- Removethenozzleaftertreatingeachpatient(aftereachear)
- Immediatelypositionthewater-pistolwiththelteroutletpointing
downwardsandrinseforsomesecondswithwater
- Attachanewnozzle(reprocessed)tothelteroutlet
- Alternatively,forstorage(e.g.overnight)sealthelteroutlet
withasterileCombi-stopperclosingcone
5 Removal of used lter / lter change
Please disinfect your hands and wear disposable gloves before installing the lter
- Attheendoftheoperatingtimeof4weeks,dismantleanddisposeoftheusedlter
- Installanewlter(seepoint4)
6 Accessories for Germlyser®ENT
- Combi-stopperclosingcone(sterile),PU:10pieces
ItemNo.:100132
- ShortnozzleforENT-waterpistols,extrashort(5cm)
ItemNo.:100351
- SplashguardforENTnozzle,clear
ItemNo.:100362
4 Preparation of commissioning and use of product
Please disinfect your hands and wear disposable
gloves during lter installation
4.1Filterinstallation
- Openthepackagingtoexposetheinletofthelter
- Leavethelterinitspackagingandattachthelterinlet,
withaslighttwist,totheENT-waterpistol.
- Removepackaging
- Insertthenozzleconnectionontothelteroutlet
withalighttwist
- Useonlyreprocessednozzlestoavoidretrograde
contamination
Donotuseifpackage
isdamaged
SN
Manufacturerlabel
D/GB
Productinformationmaterial
Individualdisponsableproductlabel
Medicaldevicelabel
Sterilisedusingirradiation
3 Labelling