17
Instructions for Use
Carrier
Processing
Carrier
3. Machine cleaning
Place the instruments on sieve baskets or racks suitable for cleaning purposes and ensure that the water jet can reach all
areas. A 0.5% alkaline cleaner (e.g. Deconex 28 Alka One, Borer Chemie) should be used according to the manufacturer's in-
structions for use. Pay attention to the correct dosage!
Carrier
is approved for alkaline cleaning. Acidic cleaning
agents and disinfectants must not be used.
The device manufacturer's instructions must also be followed. A typical cycle should include the following steps:
•
At least 2 minutes of pre-washing with cold water
•
Treat for at least 5 minutes with 0.5% alkaline cleaner (e.g. Deconex 28 Alka One, Borer Chemie)
below protein coagulation temperature (<60 °C)
•
At least 3 minutes neutralisation with warm, fully demineralised water (>40 °C)
•
At least 2 minutes of rinsing with warm, fully demineralised water (>40 °C) to remove cleaning agent
•
Hot wash disinfection (max. 93 °C)
•
Dry cycle (max. 60 °C)
The precise parameters may vary depending on the load and the program.
The instruments should be removed from the machine immediately after the end of the program and cooled to room tem-
perature. They should not be left in the washing machine after the washing process.
After cleaning, check all parts for visible dirt (especially in cannulations and blind holes). If necessary, repeat the cycle or
clean manually. All articulated parts must be dried after cleaning. Inspect parts for damage that could impair their function-
ality. Damaged and defective instruments must be identified and replaced. Instruments to be returned to fasciotens GmbH
for repair must also be sterilised beforehand (individual packaging, see section Sterilisation). Please use the template for
returns from your AEMP/ CSSD folder for this purpose.
After each cleaning and cooling cycle, areas such as joints, sutures, etc. must be treated with suitable care products (medic-
inal white oil).
Sterilisation
Instruments can be sterilised individually wrapped (in a standard sterilisation pouch) in appropriate container systems or
general purpose sterilisation containers. The containers should not be overloaded. Please pay attention to the manufactur-
er's instructions!
Sterilisation should be carried out in accordance with a validated procedure using steam with fractionated pre-vacuum (e.g.
steriliser according to EN 285 and validated according to DIN EN ISO 17665-1). An exposure time of at least 5 minutes must be
maintained at a temperature of 134 °C. All joints and eccentric closures must be open during sterilisation.
Final instructions
These instructions have been determined by fasciotens GmbH to be suitable in order to prepare
Carrier
for re-
use. The processor is responsible for ensuring that the processing carried out with the equipment, materials and personnel
used in the processing facility achieves the desired results. This normally requires validation and routine monitoring of the
process. Likewise, any deviation from the instructions provided should be carefully evaluated by the processor to make sure
they are effective and to identify any potential adverse consequences.
We hereby confirm that no products leave our facility until appropriate quality control has been performed. Nevertheless,
issues are possible. Please check the goods are complete and functional and inform us immediately if you have any com-
plaints. Please do not use rejected goods!