Olympus EVIS EXERA II Instructions Manual page 11

EVIS EXERA II TJF TYPE Q180V REPROCESSING MANUAL
• Instructions provided in this manual are not valid for Olympus
devices repaired by a non-Olympus facility. The Olympus
recommended reprocessing procedures have not been
validated for reprocessing devices repaired by a
non-Olympus facility. In the event that your device has been
repaired by a non-Olympus facility, contact that repair facility
for instructions regarding reprocessing.
• Prions, which are the pathogenic agent of the
Creutzfeldt-Jakob disease (CJD), cannot be destroyed or
inactivated by the cleaning, disinfection, and sterilization
methods stated in this instruction manual. When using the
endoscope and accessories on patients with CJD or variant
Creutzfeldt-Jakob disease (vCJD), be sure to use them for
such patients only, or immediately dispose of them after use
in an appropriate manner to prevent the usage of exposed
devices on other patients. For methods to handle CJD, follow
the respective guidelines in your country.
• The endoscope and accessories may be damaged by
published methods for destroying or inactivating prions. For
information on the durability of Olympus equipment against a
particular reprocessing method, contact Olympus. In general,
Olympus cannot guarantee the effectiveness, safety, and
durability of cleaning, disinfection, or sterilization methods
not described in this reprocessing manual. If you chose to
use a reprocessing method not recommended in this manual,
the local institution and/or physicians must assume
responsibility for its safety and efficacy. Make sure to
carefully inspect each piece of endoscopic equipment for
irregularities (damage) prior to each patient procedure. Do
not use the equipment if any irregularity is found.
• Good quality control practices typically require appropriate
documentation. Items such as local SOPs (standard
operating procedures), confirmation of operator training,
routine testing of the disinfectant's MEC (minimal effective
concentration), confirmation of the disinfectant's use-life,
etc., should be documented as performed.
Chapter 1 General Policy
7