Aqua Free Germlyser ENT Mode d'emploi

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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

[email protected]

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

[email protected]

www.aqua-free.com

Instructions for use

Germlyser

ENT

Table of contents

1 Product

2 Certificates / Declaration of conformity

3 Labelling

4 Preparation of commissioning and use of product

5 Disassembly of used filter / filter change

6 Accessories

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