Pentax EC-380LKp, Owner'S Manual, Page: 38 / 52

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4-1-5 STERILIZATION
Before any attempt is made to sterilize the endoscope, the complete cleaning procedure as described elsewhere in
this manual must have been completed.
A) Ethylene Oxide Gas Sterilization (Recommended)
Ethylene Oxide (ETO) Gas Sterilization can be performed on these endoscopes, provided the following special
instructions, which may differ from other endoscopes, are followed to ensure the proper performance of the instru-
ment. Adhere to the sterilization manufacturer’s instructions and always use a biological indicator.
1) The endoscope must first have been properly cleaned
and thoroughly dried according to the instructions in
this manual and each of the component parts such as
air/water valve, suction control valve, rubber inlet seal,
etc. should be removed.
2) The following parameters for Ethylene Oxide Gas Sterilization are proposed.
3) Following ETO Gas Sterilization, aeration time of 72 hours at room temperature is required.
4) Aeration Chamber: To shorten the aeration time to 12 hours, an aeration chamber may be used, provided the
temperature does not exceed 55°C (131°F).
B) Other Methods of Sterilization
Other types of sterilization systems/processes are available for the reprocessing of medical devices. However,
due to the heat sensitive nature and/or the specific biocompatible materials used in the construction of flexible
endoscopes, some of these marketed systems/processes/ solutions could have detrimental effects on flexible
endoscopes.
To avoid the potential for instrument damage and/or scope failure, confirm the compatibility of such reproc-
essing systems/solutions first with the OEM of the reprocessing agent/sterilization process and then confirm
with your local PENTAX dealer prior to use with any PENTAX products. Prior to using other methods, con-
firm the specific compatibility and sterilization claims of ANY sterilizing methods/processes with the steriliz-
er manufacturer and ensure manufacturer that they have performed microbiological validation studies that
support their claims of achieving sterilization of device specific flexible endoscopes and scope components.
CAUTION:
NEVER place the endoscope in a steam autoclave!! NEVER subject the endoscope to ultrasonic clean-
ing methods employing high-frequency ultrasound!! Follow provided ETO gas sterilization Parameters.
a)
b)
CAUTION:
Prior to placing these endoscopes in a Gas Sterilizer or Aeration Chamber:
a) The ‘Red’ ETO gas sterilization venting cap MUST be “ON” securely.
b) The PVE soaking cap should be “OFF” the electrical contacts.
This is opposite of the immersion instructions.
WARNING:
Failure to thoroughly dry all surface areas could result in incomplete or ineffective sterilization. Moisture
could prevent contact of the ETO gas with the actual contaminated surfaces.
Temperature:
55
°C
(131
°F
)
Relative Humidity: 50%RH
EO Concentration: 600-650 mg/L
Gas Exposure Time: 5 Hours
Aeration:
12 Hours at 55
°C
(131
°F
)
CAUTION:
Prior to placing these endoscopes in an aeration chamber the ‘RED’ ETO Gas Sterilization Venting Cap
MUST be “ON” securely and the PVE soaking Cap should be “OFF” the electrical contacts.