Cousin Biotech INTRASPINE Gebrauchsanweisung Seite 4

Cycles parameters
Pre-cleaning
Cleaning
Draining
Thermic draining
Drying
6 Final Rinse
7 Final Drying
8 Tidying
B- Chart Just manual cleaning :
Step Step
Description
1 Contamination
Removal
2 Drying
3 Disinfection
Application
4 Drying
5 Manual
Disinfection
6 Rinse and
finition
7 Final Rinse
8 Final Drying
9 Tidying
Note: In case of suspection of Creutzfeld-Jakob Disease (CJD), incinerate the ancillaries and the fixation pliers
In case of no respect of the instructions mentioned above, the healthcare center will have to apply a validated equivalent cleaning process
for which it will be fully responsible.
STERILIZATION OF ANCILLAIRES
Sterilization is performed under the responsibility of the healthcare centers.
The following prescribed methods and materials must be used to reduce the risk of transmission of UTA, (French health ministry -
DGS/R13/2011/449 dated 01/12/2011).
1- The sterilization in autoclave is to make in a specific container (fenced basket, Tray, Plastic tray placed in a peelable pouches
autoclavable).
NB: It ТЬЧ'ЭΝЫОМoЦЦОЧНОНΝto realize the sterilization with peelables pouches autoclavable without a container  Ancillaries can pierce the
films components the pouches.
2-A sterilization BY AUTOCLAVE is advised following this protocol:
Steam sterilization parameters
Cycle Type
Set Point Temperature
Cycle Time
Dry Time
Cool Time (inside and outside the autoclave chambers)
Instructions of cleaning in washer / disinfector
Time
2 minutes
5 minutes
2 minutes
5 minutes
25 minutes
Rinse carefully with distilled water
Dry devise utilizing medical quality filtered air
The instruments have to be placed in the right
position inside the trays as described on the position
map fixed on the tray for the sterilization.
Step Instruction
Rinse product room temperature running tap water
removing any visible organic material with assistance
of a soft bristle brush
Dry the device utilizing a dry non-shedding wipe.
Medical quality filtered air may be utilized if available
Prepare a low-foaming neutral enzymatic detergent
solution, using tap water (15-25°C / 59-77°F).
Soak the instrument in the open position (if possible)
during minimum 1 minute.
During the immersion, actuate mobile parts of the
instrument minimum 3 times (if possible),so that the
detergent can access all parts of the instrument.
After the soaking time, take out the instrument and
wipe it with a disposable cloth. Then, place the
instrument in a new bath of enzymatic detergent
solution using warm tap water.
Brush all surface of the instrument using a soft brush
for 2 minutes.
Adjust brushing time if needed.
Actuate mobile parts of the instrument 3 times (when
applicable) and use a syringe to access all difficult
areas. Use a volume of 60 mL of the detergent
solution.
Soak the instrument in reverse osmosis water for 1
minute.
Use a syringe and 60mL of reverse osmosis water to
access all difficult areas.
Repeat soaking 2 additional times using fresh water
Rinse carefully with distilled water
Dry devise utilizing medical quality filtered air
The instruments have to be placed in the right
position inside the trays as described on the position
map fixed on the tray for the sterilization.
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Minimum temperature
<45°C / <113°F
55°C / 131°F
<45°C / <113°F
90°C / 194°F
> 70°C / > 158°F
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Accessories
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Values
Pre-vacuum
134°C / 273°F
Minimum 3 minutes
Minimum 20 minutes
Minimum 40 minutes
Type of detergent/water
Tap water
Detergent
Tap water
Reserve osmosis water
Not applicable
Minimum 1 minute
Distilled water
Until product is
Medical quality
visually dry
filtered air
Duration
Until all visible soi
Tap water
lis removed
Soft bristle brush
(Do not utilize
metal cleaning
brushes)
Until product is
Non-schedding wipe
visually dry
Medical quality
filtered compressed
air
Minimum duration
Detergent
1 minute, this
duration can vary
according product
Until product is
Disposable cloth
visually dry
Detergent
Manual cleaning
Soft bristle brush
time duration is
Detergent
complete when the
Syringe
НОvТМО'sΝsurПКМО,Ν
joints, and crevices
have been
manually cleaned
Minimum 1 minute
Reserve osmosis
water
Syringe
Minimum 1 minute
Distilled water
Until product is
Medical quality
visually dry
filtered air
Values
Pre-vacuum
132°C / 269.6°F
Minimum 4 minutes
Minimum 20 minutes
Minimum 40 minutes