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This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with
the user to ensure that the most up-to-date IFU is used.
Never use wire brushes or steel wool to clean any instruments, instrument storage trays or sterilization containers.
Cleaning and disinfection
Basic principles
Use a mechanical procedure (disinfecting machine) to clean and disinfect the instruments, when possible. Because a manual procedure is
considerably less effective and reproducible (even when using an ultrasonic bath), it should only be used when a mechanical procedure is
unavailable. Instruments must be taken out of the trays for cleaning and disinfecting!
Pretreatment
Pretreatment must be done for both mechanical and manual processes. Major impurities must be removed from the instruments directly after
use (within max. 2 hours). Use running water or a disinfectant for this; the disinfectant should be aldehyde-free (otherwise fixation of blood
impurities could occur), be demonstrably effective (e.g. FDA clearance), be suitable for instrument disinfection and be compatible with the
instruments (see the „Material stability“ section). To remove impurities manually, use only a soft brush or a clean, soft cloth which you use
exclusively for this purpose; never use a metal brush or steel wool.
Move moveable parts, such as push-buttons/release buttons or hinges, during the preliminary cleaning.
If applicable: Rinse all the lumina of the instruments five times using a disposable syringe (minimum volume: 50 ml).
The disinfectant used during pretreatment is only intended for personal protection and does not replace the subsequent disinfection step
after successful cleaning.
Mechanical cleaning/disinfection of instruments
When selecting a disinfecting machine, please ensure that:
The disinfecting machine features proven evidence of efficacy, (e.g. FDA clearance);
If possible, a tested thermal disinfection program should be used (A
0
value > 3000, or, for older devices, at least 10 minutes at 93 °C [199 °F])
(chemical disinfection runs the risk of leaving disinfectant residues on the instruments);
The used program is suitable for the instruments and contains sufficient rinsing cycles;
The water used (e.g., purified water/highly purified water) for rinsing is sterile or nearly sterile (no more than 10 microbes/ml) and low in
endotoxins (no more than 0.25 endotoxin units/ml).
Filtered air is used for drying; and
The disinfecting machine undergoes regular maintenance and inspections. When selecting a cleaning agent system, please ensure that:
It is suitable for cleaning the instruments;
If no thermal disinfection is used – a suitable disinfectant with proven efficacy (e.g. FDA clearance) is additionally used and that it is compa-
tible with the employed cleaning agent;
The manufacturer‘s concentrations and application times for the cleaning agent and/or disinfectant are strictly complied with.
Process for mechanical cleaning/disinfection of instruments
1. Disassemble the instruments according to the manufacturer‘s instructions.
2. Place the disassembled instruments into the disinfecting machine. Place the instruments which, according to the manufacturer‘s inst-
ructions, do not need to be disassembled entirely into the disinfecting machine. Make sure that the instruments do not touch each other.
3. Close all lumina of the instruments (using a suitable flush adapter) on the disinfectant machine‘s flush connection.
4. Open instruments with hinges in order to minimize contact of the components amongst themselves. Fixate the hinges with spring mecha-
nism with the corresponding tools, if necessary.
5. Start the program.
6. Remove the instruments from the disinfecting machine after the program has finished. Ensure that the instruments are dry after cleaning/
disinfection. If necessary, subject the instruments to additional drying in a clean location.
7. Check and package the instruments as soon as possible after removal (see the „Inspection,“ „Maintenance“ and „Packaging“ sections).
Manual cleaning/disinfection of instruments
Combined cleaning agents/disinfectants should only be used in the event of extremely little initial impurity (no visible impurities) of the
instruments.
Process for manual cleaning of instruments
1. Disassemble the instruments according to the manufacturer’s instructions.
2. Place the disassembled instruments into the cleaning bath for the specified application time so that the instruments are sufficiently im-
mersed (if necessary, use ultrasound or carefully clean with a soft brush). Place the instruments which, according to the manufacturer’s
instructions, do not need to be disassembled entirely into the cleaning bath for the specified application time so that the instruments are
sufficiently immersed (if necessary, use ultrasound or carefully clean with a soft brush). While doing so, ensure that the instruments do not
touch each other.
3. If applicable: Rinse all the lumina of the instruments five times at the beginning and/or end of the application time using a disposable
syringe (minimum volume: 50 ml), a suitable flush adapter and a sterilization agent and disinfectant for ultrasonic cleaning.
4. Clean the instruments in the ultrasonic bath (35 to 40kHz) for 5 minutes.
2019-07-02
