General Specifications; Indications For Use; Installation Instructions - Delabie BIOFIL 30261 Manual Del Usuario

1
REFERENCES
• BIOFIL Shower head water filters: 30261, 30361, 30461.
• BIOFIL Tap water filters with straight flow outlet: 30251 , 30351, 30451.
• BIOFIL Tap water filters with shower flow outlet: 30250 , 30350, 30450.
To guarantee the optimal performance of the BIOFIL disposable water filters, please ensure that you follow
the instructions for installation (see  ) and read the warnings carefully (see 6 ).
2

GENERAL SPECIFICATIONS

• Disposable water filters.
• Effective against bacteria including opportunistic waterborne pathogenic microorganisms.
• 2, 3 & 4 months.
BIOFIL filters are class I medical devices in Europe.
3

INDICATIONS FOR USE

BIOFIL 2, 3 & 4-Month water filters provide a barrier against waterborne microorganisms such as bacteria (Legionella
pneumophila, Pseudomonas aeruginosa and other Gram negative bacilli, nontuberculous Mycobacteria), fungi (Aspergillus sp,
Fusarium sp), protozoa and particles originating in the water distribution system. The microfiltration membrane protects immune-
supressed patients and vulnerable people. Filters are necessary for the care of hospitalised, immune-suppressed patients in high-
risk areas such as bone marrow transplant and organ transplant units, oncology services, intensive care units, resuscitation,
neonatal services and any other places that care for this type of patient.
4
DESCRIPTION
The BIOFIL filters are intended to produce bacteriologically controlled water at the point-of-use. These devices retain bacteria,
including opportunistic waterborne pathogenic microorganisms such as Legionella spp., Legionella pneumophila, Pseudomonas
aeruginosa and others via a microfiltration membrane. This microfiltration technology ensures as a higher bacteriological quality
than the potable water of the water plumbing system. Please note, the BIOFIL devices do not contain latex, nor tissue or by-
products of animal origin, neither are they derived from blood or any substance considered as a medicine.
BIOFIL disposable water filters are designed to ensure water safety at the point-of-use. They are recommended in the procedures
for management and prevention of healthcare associated infections.
BIOFIL filters use a 0.1μm nominal / 0.2μm absolute tubular membrane filtration technology of sterilising grade (see 9-A).
The filters provide a high-performance level of water microfiltration while delivering a comfortable flow for users.
Microbiological challenges, conducted in laboratories with Brevundimonas diminuta, Legionella pneumophila and Pseudomonas
aeruginosa species on BIOFIL filters, demonstrate a retention efficiency of 7 log (see 9-2) for all water-borne microorganisms
greater than 0.1μm nominal / 0.2μm absolute and qualify the filter as a sterilising grade filter (see 9-A).
5

INSTALLATION INSTRUCTIONS

Warnings:
• Filter installation must conform with professional aseptic techniques. Hands must be disinfected prior to installation.
Inappropriate installation may result in a source of contamination or retro-contamination.
• Make sure that the individual unit packaging (plastic bag) is not punctured or torn and that the filter is not damaged.
If this is the case, do not use the device, as the performance can no longer be ensured.
General information:
• The threaded shower head filter: can be attached quickly, screw in clockwise until the seal is right up against the flexible hose.
The supplied seal must be fitted to ensure waterproofing and prevent possible leaks. It is advisable to replace the seal each
time the shower head is changed.
• The clip-on tap filters: must be fitted using the correct push-fit connectors enabling the filter to be connected
and disconnected with ease to the water control.
Contact us for the list of available connectors.
Installation:
1. Turn off the water supply.
2. If this is the first installation: remove the original shower head or fit the adaptor, if necessary, for the tap, wall-mounted
shower (see removal below).
3. Remove the used BIOFIL filter.
4. Carefully open the individual unit packaging (bag), making sure that the filter remains inside the bag. Do not touch
the end of the tap or the shower head with your fingers to avoid contamination.
5 . . K eeping the filter in the bag, screw the shower head filter onto the end of the hose or clip on the tap or wall-mounted
shower filter.
6. The bag can then be removed.
7. Turn the water on for a few seconds to check that the adaptor(s) and the filter are perfectly watertight.
In the case of leaks, repeat the installation procedure, using a new filter if needed.
EN FR