AquaTools FILT'RAY 2G Mode D'emploi page 11

Blockage tolerance:
FILT'RAY Disposable Water Filters have a certain amount of tolerance to blockage with the Bubl'AirWash Technology (see 9 -B).
2G
Nevertheless, the flow rate at the point of use may decrease somewhat before the end expiration date if there are unusually
high levels of particles or suspended microorganisms in the water supply (for example, after a maintenance procedure has been
performed). If the flow rate becomes too slow for user comfort, simply replace the filter.
8
PRODUCT COMPLIANCE
Sterile FILT'RAY Disposable Water Filters:
2G
• Are sterilised by gamma irradiation in compliance with ISO 11137. Do not re-sterilise.
• Are Class I Medical Devices in France - complying with directive 93/42CEE. CE marking 0459: year 2020.
• Are Class II Medical Devices in the USA (FDA-510K clearance).
• Dispose of the used filter according to your institution's established procedures. Class I Medical Devices in Canada
complying with DORS/98-282.
• A non-leaching bacteriostatic agent is embedded into the housing material to minimise the risk of retro-contamination
of the devices. Laboratory based microbiological tests have demonstrated that the bacteriostatic agent allows a reduction
in the external surface contamination by more than 99.9% for Pseudomonas aeruginosa, Escherichia coli, Staphylococcus
aureus and Methicillin-resistant staphylococcus aureus (MRSA) (see 9 -2).
• Comply with drinking water certifications (ACS-France, KTW-Germany, WRAS-United Kingdom, WaterMark-Australia/New Zealand).
• Meet the requirements of the Australian/New Zealand Standards AS/NZS 3497 "Drinking water treatment units"
and AS/NZS 4348 "Water supply - Domestic type water treatment appliances - Performance requirements" for the class II(a):
microbiological treatment - bacteria removal. Certification and WaterMark marking. For more information, please refer to
the performance data sheet - available upon request.
9
MANUFACTURING INFORMATION
FILT'RAY Disposable Water Filters are manufactured in France by:
2G
aqua-tools | 26, rue Charles-Édouard Jeanneret | 78300 POISSY | France
1. For more information, visit our website at: www.aqua-tools.com
or contact us: tel.: + 33 1.39.75.02.20. e-mail: contact@aqua-tools.com
2. The "Scientific and Technical Validation Guide" for the relevant product is available on request.
References:
A. Sterilising grade filter is defined in "American standard Test Method ASTM F838-15a and in FDA - Guidance for Industry
- Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice" as a filter ability to sustain
a bacterial challenge of 10
B. The Bubl'Air Wash™ Technology is a mechanism to extend the service life of the filter which introduces turbulent flow during
filtration to keep particulates from becoming fully trapped on the membrane and permits the filters to have long-life use.
Product label - meaning of symbols
(Rx only: "Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.")
Catalogue number
Sterilised using irradiation
Free from natural latex
NON
STERILE
Non-sterile
CFU of Brevundimonas diminuta per cm² of filtration surface.
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Consult instructions for use
Batch code
STERILIZE
Do not resterilise
Manufacturer
Use by
Do not use if packaging is damaged
CMA-WN-080040
AS/NZS 3497
WaterMark marking: License number for AS/NZS 3497
compliance by CertMark International
Compliant with the essential requirements