Brainlab RT/RS Hardware User's Manual page 96

Reprocessing
Thermo Disinfector
Pay attention to the following points during thermo disinfection:
Disinfector
Program
Water
Maintenance &
Calibration
Validation Parameters
The fundamental suitability of the instruments for effective automatic cleaning and disinfection was
validated by an independent test laboratory using the following parameters:
Thermo disinfector machine
Manufacturer
Cleaning detergent
Manufacturer
Concentration
Other Procedures
If procedures other than those described above are used (for example: chemo disinfectant), the
fundamental suitability and efficiency must be validated.
96
The disinfector should have regulatory clearance in the jurisdiction in which it
is being used. For example:
• FDA clearance
• CE marking
• Products listed by DGHM (German Society for Hygiene and Microbiology)
and ÖGHMP (Austrian Society for Hygiene, Microbiology and Preventive
Medicine)
Only a cleaning and disinfection program that is recommended by the Robert
Koch Institute may be used. This program must comprise at least 10 min. at
93°C/195.4°F, with sufficient rinsing and drying steps and filtered air.
Only sterile or low contaminated (< 10 cfu/ml) distilled or deionized water can
be used for post-rinsing.
Periodical maintenance and calibration of the washer-disinfectant must be per-
formed.
Type: MCU G7736CD
Miele
Type: neodisher® MediZym (pH neutral cleaning solution)
Dr. Weigert
In accordance with manufacturer's specifications
Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware