SAEVO EVUS 8, Owner'S Manual

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13 Probes and Biopsy
116 Basic User Manual
2. Disconnect the probe from the system and remove the probe sheath and biopsy bracket from the probe.
3. Use a lint-free soft cloth dampened with mild soapy water or the recommended cleaner (see Appendix D.2
Cleaner) to wipe the probe.
If there are dried stains on the surface or in the grooves of the probe, remove them by a brush dampened with
an enzymatic clearer.
4. Rinse the surfaces of the probe with the fresh running water to completely remove any residual cleaner.
5. Dry the probe with a lint-free soft dry cloth.
13�1�4 Disinfecting or Sterilizing the Probe
!
●
There is a cleared list of sterilants and high-level disinfectants for use in processing reusable medical and dental
devices on the FDA website. That list can be consulted to find agents that may be useful for probe disinfection.
Please refer to the following URL for FDA-Cleared Sterilants and High Level Disinfectants: http://www.fda.
gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.htm.
●
Use the liquid disinfectant/sterilant that meets local laws and regulations or the recommended disinfectant/
sterilant.
●
The probe sheath may be damaged during exam and contamination risk level caused by the damaged sheath is
difficult to estimate. Therefore, probe sheath cannot change the level of disinfection for a probe. Please clean
and sterilize (or high level disinfect) the entracavitary probe and clean and sterilze the probe for biopsy and
coming into contact blood after exam.
●
Do not use an expired disinfectant/sterilant.
● Store the probe in a sterile environment, and review its expiration date before use.
● If you use the recommended disinfectant/sterilant, ensure the requirements for the disinfection level and probe
soaking period are met. Otherwise, the probe could be damaged and your warranty might be void. If you have
further use or needs for the probe, ensure the level of the make-up disinfectant/sterilant and the probe soaking
period are suitable for the intended clinical application.
●
Do not use the following methods to sterilize the probe.
−
Autoclave
−
Ultraviolet sterilizer
− Gamma ray sterilizer
− Ethylene oxide gas
− Ethylene oxide
− Thermal disinfection/sterilization. Temperature higher than 66°C (150°F)will damage the probe.
● Do not allow any disinfectant/sterilant to be air-dried on the probe.
■ Disinfection Levels
To choose an appropriate disinfectant, you must first determine the required level of disinfection, based on the
probe classification.
Classification Definition Level of Disinfection Application
Critical A device that enters normally
sterile tissue or the vascular
system. Sterilization Intraoperative, biopsy use
or blood contacting probe
Semi-critical A device that comes into contact
with intact mucous membranes and
does not ordinarily penetrate sterile
tissue. High Endocavitary probe