Hoffrichter CARAT I, Service Manual

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3 PreParing The DeviCe when Changing PaTienT
Before using the ventilator on a different patient, clean and disinfect it to such an extent that it
is free from any human pathogens.
Please ensure that all tools used, such as measuring instruments and test lung, are free from
human pathogens.
If MRSA contamination is suspected, the device must be packaged, with the appropriate label-
ing, and disinfected accordingly.
If the accessories (e.g., tube system, mask, fi lter, humidifier, etc.) are intended for repeated use,
the manufacturer's provisions must be followed.
The reprocessing of the device acc. to procedure 1 and 2 must be documented.
3.1 REPROCESSIng PROCEDuRE 1
The following measures may only be carried out by companies with a QM system and appropriately
qualified, authorized and experienced specialist personnel.
To reprocess the device, carry out the following steps:
• Properly dispose of the carrying case and, if necessary, the functional bag, as well as all acces-
sory components that carry respiratory gas.
• Dismantle the device’s sensor block. The sensor block’s plastic parts are autoclaved. The sen-
sors must not come into contact with cleaning fluids. A spray disinfection, e.g., using Mikrozid®
Liquid, is possible. The sensors must be completely dry before replacing them in the sensor
block.
• Use the maintenance kit 1.
• Disinfect all the parts of the housing and the connections with a suitable agent, e.g., Mikrozid®
Liquid.
• Dispose of the filter cassette and replace it with a new one.
• Reassemble the device.
• After reprocessing, carry out a safety-related test according to the User’s Manual.
• Until the device is used again, store it safe from contamination with human pathogens.
3.2 REPROCESSIng PROCEDuRE 2
The following measures may only be carried out by companies with a QM system and appropriately
qualified, authorized and experienced specialist personnel.
The hygienic reprocessing of the devices during a patient change can be carried out in accordance
with the validated KR 1000 procedure. The type and scale of the reprocessing are described in
detail in the “Instructions for validated ventilation technology”. The number of reprocessing cycles
for the device is limited to 10.
After reprocessing, carry out a safety-related test according to the User’s Manual.