Devicor Medical Products
Ethylene Oxide (EO) Reprocessing Instructions of Probes, Cables and Collimators
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Ethylene Oxide (EO) Reprocessing of probes, cables and collimators according to EN ISO 17664:2004 Method: EO
Symbol:
Manufacturer:
Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 US
Model 1100, 1101, 1102, 1104
Model 1017, 1103, 2059
Model 2021, 2024, 2060
Model 1013
Devices(s): All reusable probes, cables and collimator supplied by Devicor Medical Products, Inc. comprising fixed assemblies (no moving parts); sold nonsterile. WARNING: Limitations on reprocessing: INSTRUCTIONS: Point of use: Containment & Transportation:
Preparation for cleaning:
Cleaning - Automated: Cleaning: Manual
Disinfection:
Drying: Maintenance: Inspection & Function Testing: Packaging: Sterilization:
AW-000711
Do Not exceed 60ºC for probes and cables during cleaning or drying cycles. Repeated processing has minimal effect on these instruments. End of life is normally determined by abrasion, wear and damage due to use. Detach the external collimator from the probe, if used. Remove the excess soil and surface contamination with disposable cloth/paper wipe. Loosely coil the cable and place in plastic container to protect the probe, cable and collimator from damage during transport. No particular requirements. It is recommended that instruments are reprocessed as soon as is reasonably practical following use. WARNING: (Corded Probe): To avoid electrical shock, disconnect probe and cable from control unit before cleaning. DO NOT disconnect the probe from the cable at this time. WARNING: (Wireless Probe): Remove battery from Wireless Probe Models 1100, 1101, 1102 and 1104. To avoid permanent damage, do not immerse the probe with the battery cap loose or removed. Does not apply. Equipment: enzymatic detergent, soft cloth, running water. Method: All Probes, Cables, Collimator: 1. With the cable still attached to the probe (corded probe) or battery removed and battery cap installed (wireless probe), rinse outside surfaces with brisk stream of water. Wipe with soft cloth soaked with enzymatic cleaner suitable for surgical instruments. Repeat process separately for collimator cleaning. 2. Visually inspect for contaminated areas. 3. Repeat Steps 1 and 2 until visual inspection reveals instrument is clean. Detach probe from cable (if applicable). 4. Rinse with a brisk stream of water for 30 seconds and dry with clean soft cloth. 5. Repeat steps 1 to 4 until visual inspection assures instrument is clean. Wireless Probes Only: 6. Inspect the battery cap and o-ring. 7. Using a soft cloth dampened with the enzymatic detergent solution, clean the battery cap and opening. 8. Rinse the battery cap and opening with a brisk stream of water for 1 minute and dry with clean soft cloth. Inspect. 9. Repeat steps 6-8 until the device passes inspection. Disinfectant solution may be used in accordance with label instructions. WARNING: to avoid health hazards comply with the disinfectant manufacturer’s instruction. 1. Prepare mixture according to manufacturer’s instructions. 2. Ensure battery cap is installed (wireless probe), DO NOT soak the probe and cable connectors (corded probe) or the silicone button area (wireless probe). 3. Soak the product for 5–20 minutes. Cover all areas, except connectors, battery cap and silicone button area, including niches and joints. 4. The connector ends of corded probes and cables and/or the battery cap and silicone button area of the wireless probes should be swirled in 100 milliliters of clean enzymatic solution for at least one minute, but no more than two minutes. 5. Rinse with brisk stream of water for approximately 30 seconds and dry with clean soft cloth. When drying is achieved as part of disinfection cycle, do not exceed 60ºC. Do not use damaged instruments. All instruments: Visually inspect for damage or wear, including around silicone button area (wireless probe), prior to use. Where instruments form part of a larger assembly, check assembly with mating components. Singly – a standard packaging material may be used. Ensure that the pack is large enough to contain the instrument without stressing the package seals. EO: EO Process Phase Parameter Value Preconditioning None None Sterilization Temperature 48.9 to 54.4 ºC set point of 55 ºC Pressure 690 to 827 hPa gauge (10 to 12 PSIG) Humidity > 70 % RH Humidity Dwell 30 – 45 minutes Sterilant Gas 100% EO
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Ethylene Oxide (EO) Reprocessing of probes, cables and collimators according to EN ISO 17664:2004 EO Gas Concentration Exposure time
Storage: Additional Information: Manufacturer Contact:
883 ± 30 mg/L 48 – 60 minutes 1.93 – 2.91 PSIA (3.93 – 5.92 inches Hg) single Post Exposure Evacuation Post-vacuum time ≥12 hours at 50 to 57.2ºC or 7 days at room Aeration Time/Temperature temperature No particular requirements. Protect during transport between cleaning and sterilization. Once sterilized, protect from contamination. When sterilizing multiple instruments in one sterilizer equipment, do not exceed the sterilizer’s maximum capacity. Do not immerse the connector of the probe in fluids. See product brochure for telephone and address of local representative or telephone (+1) 877-926-2666.
NOTE: The instructions provided above have been validated by the medical device manufacturer as being capable of preparing a medical device for re-use. It remains the responsibility of the reprocessor to ensure that the reprocessing as actually performed using equipment, materials, and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.
AW-000711
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