10
Probe Sterilization
A:
Recommended sterilization procedures for CE-2000™ probes:
The CE-2000 probes can be sterilized with steam (Pre-Vacuum and Gravity Displacement) or ethylene oxide gas
(ETO) sterilization process. For convenience, most users sterilize their operating room instruments where possible.
CooperSurgical, Inc., recommends:
Gravity Displacement
RECOMMENDED HOSPITAL ETHYLENE OXIDE CYCLE
270–275 °F (132–135 °C) • 10-15 minutes
Temperature
124–131 °F (51–55 °C)
250 °F (121 °C) • 15-30 minutes
50% RH (pre-humidity) 60 minutes -0/+10 minutes
Dry Time: 10.0 minutes
Pre-vacuum Cycles
270–275 °F (132 –135 °C) • 3-4 minutes
Pre-vacuum
24 in. Hg ± 2 in. Hg (610 mm Hg ± 51 mm Hg)
Dry Time: 10.0 minutes
Gas Pressure
6-8 psig (650-660 mg/L EO)
Exposure Time
4 hours minimum
Post Vacuum
24 in. Hg 2X ± 2 in. Hg (610 mm Hg 2X ±
51 mm Hg)
Aeration
12 -0/+1 hours at 124-131 °F (51-55 °C)
NOTE:
The particular EO cycle should be validated per the equipment manufacturer’s requirements. It is
recommended that each institution employ procedures which include the use of biological indicators in order to
determine the effectiveness of the ethylene oxide process.
Prior to sterilization, all probes must be “wiped” clean of blood and contaminants (alcohol recommended).
Do not immerse probe in any solution.
The above cycles and conditions will vary. The actual degree of sterility is dependent on the equipment,
maintenance of equipment, cycle and product to be sterilized.
Again, the above recommendations match those cycles presently used successfully on our products in the field.
Sleeve Sterilization
It is recommended that sleeves (used with retinal probes Numbers 124, 125, 126, 127, 128, 130, 134-142, 143,
144,147, 708-4, 708-5, 161, 162, 163, 164, 165, 166, 167, 171, 172, 173, 228, 237, 238 and 239) be removed
and cleaned before sterilization. Sleeves may be sterilized using same technique (sterilization methods) and
parameters as mentioned above for probes. Use (sterile) alcohol to lubricate sleeve before reapplying to probe.
Do not remove sleeves from Pediatric Probes Numbers 123 and 148. Sleeves may be removed from Pediatric
Probes Numbers 120 and 121.
Spherical probe Number 139 may be sterilized with sleeve.
Cartridge Replacement
Filter assembly for nitrous oxide and carbon dioxide gases.
Removal of oils and water.
1.
Shut off the valve or valves at all supply cylinders.
2.
Bleed off the gas in the lines until the pressure gauge needle touches the silver stop.
3.
Unscrew the shell casing from the assembly.
4.
Unscrew the cartridge from the assembly and discard.
5.
Each cartridge is supplied in a hermetically sealed container. Open the container and remove new cartridge.
NOTE: Do not remove purifier cartridge from hermetically sealed container until ready to install in purifier.
6.
Screw the new cartridge into the assembly, and screw the shell casing into place. Ensure that the “O” ring seal
is properly seated. If difficulty is encountered when installing the shell casing due to the “O” ring, replace worn
“O” ring with new replacement. “O” rings may have to be replaced with each cylinder change.
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