DePuy Synthes BI-MENTUM Serie Instrucciones De Uso página 13

EN
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Places of use Do not put soiled instruments back in their box.
Disassemble instruments where required.
Remove residue from instruments by rinsing them
under cold water or wiping them with a cleaning cloth.
Confinement We recommend that instruments
and transport be reprocessed straight after use.
During any waiting period during or after the operation,
put the instruments into a neutral aqueous
solution (physiological fluid, for example).
Manual Equipment: detergent (Alkazyme
cleaning made by Alkapharm / concentration 0.5 %), soft,
non-metallic brush, tap water, demineralised water.
Note: take care not to bump or damage
the ancillary equipment.
1. Fully submerge the instrument trays in the cleaning
bath at a temperature of less than 45° C (ambient
< 30° C). Open up articulated instruments and
disassemble those that have several parts prior to
immersion. Respect the soaking time recommended
by the product manufacturer (15 min minimum).
2. Brush the outside and inside of the instruments
to remove persistent dirt, taking care
not to forget areas of abrasion.
Circulate the solution in the hollow parts
of the equipment to remove the residue.
Rinse thoroughly by soaking (temperature < 30° C)
and /or spraying with water, preferably
demineralised, to remove the detergent and dirt.
Automated Equipment: washer / disinfector in compliance
cleaning with NF EN ISO 15 883-1&-2 (HAMO T21),
detergent (Néodisher
0.5 %), rinsing product (Néodisher
concentration 0.05 %), demineralised water.
Note: manual method with additional
washing in machine preferable.
1. Place the ancillary equipment open wide if
articulated, or disassembled if in several parts.
Direct cavities so that water will flow out.
2. Start a cycle:
– cold water prewash without any product,
– wash at least 15 min at a temperature
of less than 50° C (45° C),
– rinse in cold demineralised water.
3. When unloading, inspect instrument
surfaces and cavities to check that all visible
dirt has been completely removed.
If necessary, repeat the cycle or clean by hand.
Manual Soak in the disinfectant solution (Alkazyme
disinfection made by Alkapharm / concentration 0.5 %)
for 15 mins minimum, then rinse in tap water
(rinsing in demineralised water preferable).
Automated When using a washer / disinfector, it is possible to
disinfection programme a final rinse with thermal disinfection
(6 min / demineralised water at 93° C). The time depends
on the machine's size and power (NF EN ISO 15 883-1).
Drying N.B: this stage allows germ multiplication to be
avoided, removes the marks left by washing and
rinsing and optimises sterilisation effectiveness.
When using a washer / disinfector, do not exceed 120° C
(dry using air at 110° C, then cool with air at 30° C).
Manual drying should be done using a clean,
absorbent, nonwoven cloth or a clean, lint-free
cloth together with "medical" compressed air.
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Inspections On all instruments: remove and replace damaged and
and trial deformed instruments and any showing signs of bumps
or oxidation. Sharp edges must not have any notches;
worn instruments can have undesirable effects on other
instruments in good condition during sterilisation.
Instruments in several parts: Check assembly and
correct functioning of mechanisms and that there is not
too much play in locking systems (clipping, gripping).
Conditioning Note: whatever cleaning method is used, instruments
must be packaged rapidly to avoid any recontamination.
Individual packaging (approved method): use a material
appropriate for sterilisation. Ensure that the bag is
large enough to hold the instrument without stretching.
Do not enclose several instruments in the same bag.
Batch packaging: the instruments must be placed
in the original kit box provided for this purpose or
in a sterilisation container. Check that the instruments
are not touching, particularly sharp instruments.
Wrap them all using an appropriate method
(e.g. paper wrapping).
Sterilisation Steam autoclave under pressure of 134° C
to 138° C for 18 minutes minimum.
To be carried out
by the hospital When sterilising several ancillary elements
in a single operation, check that maximum
load of the autoclave is not exceeded.
Conservation Separate the equipment so that there is
no contact with other devices.
Metal The manufacturer can loan hospitals metal containers
container that can be used as transport containers. These undergo
systematic inspections before being sent (cleaning,
visual inspection, operational inspection, etc.).
The manufacturer does not guarantee the
transport containers' effectiveness in ensuring and
maintaining their sterility. Obtaining and maintaining
instrument sterility is the hospital's responsibility,
in compliance with current regulations.
Nevertheless, if the hospital opts to use them as
sterilisation containers, recommendations for the use
and maintenance of these containers can be provided on
request by the manufacturer's marketing department.
9. INACTIVATION OF NON-CONVENTIONAL
TRANSMISSIBLE AGENTS (NCTA) IF NEEDED
After cleaning, equipment that requires it can undergo an NCTA inactivation
procedure. The inactivation procedure must be chosen by the customer in ac-
cordance with the directive DGS/R13/2011/449 from the 1
and published by the French Department of Health; directive on the updated
recommendations for NCTA transmission risks reduction during invasive acts.
We recommend immersing our instruments in sodium (optimum concentra-
tion is 1 mol / l of sodium hydroxide / NaOH) for an hour, then steam sterilisation
at 134° C for 18 mins minimum in a porous load autoclave (pressure steam
steriliser). We do not allow the immersion of our ancillary equipment in sodi-
um hypochlorite. It is, moreover, strictly forbidden to submerge all our boxes.
10. RINSING AND DRYING AFTER INACTIVATION
NCTA inactivation must always be followed by thorough rinsing with water. Dry
the equipment before packing it.
Thank you for your trust. We are at your disposal for any further information.
of December 2011
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