Note: Sterilization of catheters is OPTIONAL
CAUTION:
- DO NOT sterilize by autoclaving, radiation (gamma or e-beam), plasma, peroxide or formaldehyde vapor solutions.
- The catheter must be completely cleaned and dried before sterilization, and maybe aerated at room temperature or in a heated aeration cabinet. (max. 145 ºF, 63 ºC).
- The Millar catheter should not be used earlier than 5 days after sterilization.
Catheters may be sterilized in the white plastic shipping tray, and the foam dome and connector caps must be removed and placed alongside the catheter in the tray during sterilization. The caps should be saved and reused each time the catheter is cleaned. The tray, with lid, should be placed in a breathable polyethylene pouch (e.g., 3M™ Steri-Lok™) for sterilization.
Ethylene Oxide Sterilization Cycle Parameters
Preheat phase:
- Starting Temperature 110 ºF (43ºC) min.
- Duration 30 minutes
Initial Vacuum:
- 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)
- Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa/min)
Nitrogen Flush:
- 2 cycles
- Nitrogen Addition to: 28.0 ± 0.5 inHgA (94.8 ± 1.7 kPa)
- Rate: 1.4 ± 0.5 inHgA/min. (4.7 ± 1.7 kPa/min.)
- Evacuation: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)
- Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa/min)
Conditioning:
- Humidification: 1.5 ± 0.5 inHgA (5.1 ± 1.7 kPa)
- Steam Conditioning: 10 min.
- Humidity Dwell: 30 ± 5 min. at 7.5 ± 0.5 inHgA (25.4 ± 1.7 kPa)
- Relative Humidity: 15-70%
Ethylene Oxide Concentration:
- 500 ± 50 mg/L
- Dwell Pressure: 16.5 ± 1.0 inHgA (55.8 ± 3.4 kPa)
- Dwell Time: 2 hours
- Temperature: 110-130 ºF (43-54 ºC)
- Relative Humidity: 30-70% (35-44% nominal)
After Vacuum:
- Vacuum: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)
- Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa/min )
- Vacuum Hold: 10 min.
Gas Wash A:
- 4 cycles (minimum)
- Release: 30.0 inHgA/min. (101.6 ± 1.7 kPa )
- Rate: 1.4 ± 0.5 inHgA/min. (4.7 ± 1.7 kPa/min)
Vacuum:
- 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)
- Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa/min)
Release (Filtered Air):
- 28.0 ±0.5 inHgA (94.8 ± 1.7 kPa)
- Rate: 2.0 ± 0.5 inHgA/min. (6.6 ± 1.7 kPa/min)
Aeration (Hot Cell):
- Duration: At least 8 hours
- Temperature: 110 ± 10 ºF (43 ºC)
This information is valid for the following catheter models:
Small Animal (Rats / Mice)
- Single Pressure: SPR-1000, SPR-320, SPR-407, SPR-513, SPR-671, and SPR-882
- Multiple Pressure: SPR-721
- Pressure-Volume: PVR-1030, PVR-1035, PVR-1045, SPR-838, SPR-839, SPR-864, SPR-869, SPR-878, and SPR-901
Large Animal (Rabbit/Dog/Pig/Sheep/Cow/Horse)
- Single Pressure: MPR-500, SPR-249A, SPR-330A, SPR-340, SPR-340S, SPR-350, SPR-350S, SPR-370, SPR-370S, SPR-524, and SPR-595
- Implantable: SPR-407I and SPR-671I
- Pressure-Volume: SPR-877, SPR-889, SPR-894, SPR-923-1, SPR-923-2, SPR-923-3, SPR-562-1, VENTRI-CATH-507, VENTRI-CATH-507S, VENTRI-CATH-510, VENTRI-CATH-510S, VENTRI-CATH-512, VENTRI-CATH-512S, VENTRI-CATH-512, and VENTRI-CATH-512S
For further technical assistance with this or any other issue, please contact ADInstruments Technical Support by clicking HERE.