-21-
Q1E-EP1457
Levels of reprocessing requirements:
Depending on the application of the product and with regard to risk
evaluation, the user has to classify the medical device according to
the current Medical Device Directive for processing of medical devices
as uncritical, semi-critical or critical. Supporting information
concerning this topic is listed in the table below. The user is
responsible for correct classification of the medical device.
Classification Definition
Processing
uncritical Application part only contacts
intact and uninjured skin
Cleaning
Disinfection
semicritical
Application part contacts
mucosa (intracavitary
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect)
critical
Application part contacts
intracorporeal tissue
directly (operative
application)
Cleaning
Disinfection
(Disinfectant with
virucidal effect -
minimum)
Sterilization
Summary of Contents for C22P
Page 48: ... 42 Q1E EP1457 Unit mm Fig 23 Dimensions ...
Page 49: ... 43 Q1E EP1457 Unit mm Fig 24 External view with the attachment ...
Page 50: ... 44 Q1E EP1457 Unit mm Fig 25 Dimensions with the Needle Guide Bracket ...
Page 51: ... 45 E Q1E EP1457 Fig 26 External view with Ultra Pro II Needle Guide cover kit Unit mm ...
