Cousin Biotech INTRASPINE Gebrauchsanweisung Seite 3

Use of the system of COUSIN BIOTECH ancillaries and specific trial prostheses is required for implantation of the IntraSPINE® prosthesis.
Implants must be handled and stored with great care, in a dry place, protected from light and at room temperature.
Transportation: Transportation of the devices should be done in the closed vehicles in accordance with the rules for those transport
vehicles. There are no special transportation requirements for the device.
IMPORTANT : DO NOT REUSE AND DO NOT RESTERILISE THE INTRASPINE® PROSTHESIS
As indicated on the product labelling, the prosthesis is designed for single use. It should in no event by reused and/or resterilized (potential
risks include but are not limited to: loss of product sterility, risk of infection, loss of effectiveness, relapse).
EXPLANTATION AND ELIMINATION OF DEVICES
Explantation and handling should be done following recommendations of ISO 12891-1:2011 « Implants for surgery – Retrieval and analysis
of surgical implants » Part 1: « Retrieval and Handling ».
Any explanted device must be send back, for analysis, following the current protocol. This protocol is available on demand to COUSIN
BIOTECH. It is important to note that any implant that should not have been cleaned and disinfected before expedition must be contained in
a sealed package.
The elimination of explanted medical device must be conducted in accordance with standards in the country for the disposal of infectious
hazards waste.
The elimination of a non-implanted device is not the subject of specific recommendations.
WARNING ABOUT ANCILLARIES AND TRIAL PROSTHESES
®
The IntraSPINE ancillaries are Class I medical devices, intended for temporary use and are re-usable.
®
The IntraSPINE trial prostheses are Class IIa medical devices, intended for temporary use and are re-usable.
Unlike the IntraSPINE® prosthesis, ancillaries and trial prostheses (included with the instrument kit/set)
are furnished unsterile.
Before first use
Ancillaries and trial prostheses must be:
- Cleaned in the appropriate way
- Sterilised in an autoclave
DECONTAMINATION AND CLEANING OF ANCILLARIES
Decontamination and cleaning are 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).
This step has to take place before the first utilization and immediately after the utilization to avoid adhesion of particles or dry secretion
to the instruments
The detachable instruments have to be dismantled
Products advised for the cleaning
- an enzymatic detergent neutral
- Or products adapted for the cleaning (neutral or soft alkaline) of chirurgical instruments in compliance with the regulations in
effect.
- Warning: ϊШЧ'tΝusОΝМШrrШsТvОΝПКМtШrΝШrΝМКustТМΝМХОКЧТЧРΝЩrШНuМtΝ
2 process are possible
A- Chart Automated cleaning in a disinfector washer with manual Pre-cleaning:
Step Step
Description
1 Contamination
Removal
2 Pre-soak
3 Ultrasonic
cleaning
4 Soak
5 Automated
Washer
KITACINTRA / RCBININTRU
Step Instruction
Rinse product room temperature running tap water
removing any visible organic material with assistance
of a soft bristle brush
Prepare a detergent solution at ambient temperature
(15-25°C / 59-77°F).
Afterwards lumina, threads, joints and gaps of the
instruments have to be flushed with a water jet pistol
for a minimum time of 10 seconds for each position.
Clean the instrument in the ultrasonic tray including the
solution.
Be careful every unclench connector or screws
and bolts by the vibrations will be reassure.
Soak the instrument in tap water during 30 seconds.
After, ultrasonic treatment the lumina, threads, joints
and gaps of the instrument have to be flushed again
with a water jet pistol for a minimum time of 10
seconds for each position.
Place entire disassembled device into the automated
washer
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Accessories
-
Until all visible soi
Tap water
- lis removed
Soft bristle brush
(Do not utilize
metal cleaning
brushes)
-
Until product is
Detergent
- visually clean
Water jet pistol
-
Ultrasonic tray
-
Minimum 30
Reserve osmosis
seconds of soak
water
-
Minimum total
Automated Washer
- cycle time: 39
Disassembled
minutes
Device
Duration
Minimum duration
10 minutes, this
duration can vary
according product