Cleaning and Sterilization Instructions for
ETO 80%

Suggested cleaning procedure for the following Koven Technology surgical probe(s):

VDP-8A / VDP-10A
PP8M05N5A
P5M05S8A
LRP-8
PP10M05N5A
P8M05S8A
VRP Series
P5M05N5A
P10M05S8A
NRP Series
P8M05N5A
HP10M05N5A / HP20M05N5A
CRP Series
P10M05N5A
HP10M1N5AF / HP20M1N5AF

Cleaning: Probes must be cleaned to remove contaminating substances prior to sterilization. After each use, perform initial cleaning within the sterile field by wiping the probe free of blood and body fluids. Then, pass the probe out of the field. Disconnect the probe (and any adaptor) from the Doppler unit, clean the probe tip and housing thoroughly with a mild soapy solution. DO NOT SOAK. Complete preparation for sterilization in accordance to hospital procedure using an approved probe cleaning agent.

Sterilization: It is recommended that the intraoperative and laparoscopic probes be gas sterilized before each use with ethylene oxide (ETO) gas. The suggested mixture ratio is ETO gas - 20%, CO2 gas - 80%. Exposure time should not be less than 1 hour and 45 minutes at a pressure of 0.75 to 0.8 Kg/cm2 and da temperature of 50° to 60°C. To achieve a Sterility Assurance Level (SAL) of 10-6 (the recommended minimum for direct contact with blood), an exposure time of 3 hours and 30 minutes is necessary. A biological indicator strip should be placed in the load to verify the effectiveness of the cycle selected.

Warning: Do not sterilize the Doppler probes listed above by steam autoclaving. Steam sterilization is likely to damage the plastic probe tip and the piezoelectric crystals. Utilize Koven/Hadeco probe number ACP-8 for steam autoclaving.

Aeration: Follow hospital requirements with regard to aeration time to allow residual ETO gas to dissipate. The minimum recommended aeration time is 8 hours at 60°C, 40% to 60% humidity with an air change (ventilation) frequency of 25 times per hour.

Coupling for intraoperative and Laparoscopic Use: During the examination, fluid coupling must be maintained for proper signal reception. If needed, irrigate the incision or laparoscopic portal with sterile saline to insure adequate coupling. Use of sterile gel is acceptable in all areas except the brain.

Contraindications: Hospital policy and procedure(s) takes precedence over this protocol.

Failure to use approved cleaning & sterilization procedures may void the warranty

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