Aqua Free Germlyser ENT Instructions For Use

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7 Maintenance and cleaning
The Germlyser
ENT requires no maintenance within the specified operating time. The outside of the filter
®
can be cleaned using common surface disinfectants.
In the case of a deviation from the specifications 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).
Aqua free Solutions Ltd.
The Media Centre
7 Northumberland Street
Huddersfield, HD1 1RL, Great Britain
info@aqua-free.co.uk
E-Mail:
+44 (0)1484 483045
Phone:
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
info@aqua-free.com
www.aqua-free.com
Instructions for use
Germlyser
®
ENT
Table of contents
1 Product
5 Disassembly of used filter / filter change
7 Maintenance / cleaning

1 Product

1.1 Product description
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
Retention*:
7 log steps Brev. dim.
Pore size:
0.2 µm
Operating time:
4 weeks
Chlorine resistance**: ≤10 ppm
1.3 Scope of delivery
• Germlyser
®
ENT
• Sterile Combi Stopper sealing cones
• User instructions
*
Measured in accordance with the international ASTM F838-15a standard - Standard Test Method for
Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
** Continuous dosage of ≤ 10 ppm over operating time; short-term (1h) high dosage
(400,000 ppm) for chemical disinfection.
Minimum flow 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
www.aqua-free.com

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Summary of Contents for Aqua Free Germlyser ENT

  • Page 1 -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 Aqua free Solutions Ltd. immunosuppressed and immunocompromised patients. To achieve this intended use, a specific The Media Centre 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.
  • Page 2 2 Certificates / Declaration of conformity - Remove the nozzle after treating each patient (after each ear) The company Aqua free GmbH is certified according to DIN EN ISO 13485. - Immediately position the water-pistol with the filter outlet pointing The Germlyser filters are -labelled medical devices. ® downwards and rinse for some seconds with water - Attach a new nozzle (reprocessed) to the filter outlet Extract from the declaration of conformity Aqua free GmbH, Winsbergring 31, DE-22525 Hamburg: - Alternatively, for storage (e.g. overnight) seal the filter outlet with a sterile Combi-stopper closing cone 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. 3 Labelling Manufacturer label Individual disponsable product label...

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