Statim Helix Device
How this product helps you comply with HTM 01-05 (2013 Edition)
- HTM 01-05 has the steam penetration test as a daily requirement. This test can only be performed on vacuum sterilisers, with the aid of a Helix or Bowie-Dick. (HTM 01-05 2013 edition. Section 4.16) Some manufacturer’s recommend the steam penetration test to be complete at a different frequency. Please seek manufacturer’s advice on the steam penetration test, or download for FREE a validation test schedule (VTS) on the Isopharm website.
HTM 01-05 Steam Penetration Test Using the SciCan Statim Type S Helix for 2000s and 5000s Vacuum Sterilisers
|1. Unscrew the cap of the Helix.|
|2. Take a Test Strip from the pack. Only SciCan sterilisation emulator test strips should be used.|
|3. Load the test strip into the holder in the cap.|
|4. Screw the cap back into the Helix.|
|5. The test should be run from a cold start, for example the first cycle of the day.
Place the device centered within an empty standard cassette.
Process the device within cycle HOLLOW/WRAPPED (S) 134°C 3.5 minutes.
|6. When the cycle has finished, carefully remove the Helix from the chamber.|
|7. Remove the Test Strip from the cap and examine.|
|8. A uniform colour change from purple to green indicates that all air was removed during the vacuum stage of the cycle. This enabled steam to then penetrate into the helix to the test strip in the cap and pass the test.|
|9. If the original colour remains visible and the colour change from purple to green is not uniform, this indicates that the vacuum stage was not able to remove all air from the Helix. This prevented steam from penetrating to the test strip in the cap and failed the test.|
|10. Complete the Steam Penetration Test table in the steriliser log book.|
|11. The test strip should be attached into the log book as further evidence of test result.|
Reasons Why the Test May Fail
Should the test fail a re-test should be performed. If the test fails a second time, a diagnosis of both the method of sterilisation and method of testing is required.
The compliance team at Isopharm is also available to discuss the test and test method.
Possible fail reasons for the SciCan Statim Type S Helix are:
Diagnosing the Method of Sterilisation
- Check that the steriliser has been validated within the period specified by the manufacturer.
- Check that the machine is either a Statim 2000s or Statim 5000s which can perform a vacuum cycle.
Diagnosing the Method of Test
- Check that the test product used is within the expiry date provided.
- Check that the test product is being stored as manufacturer recommendations.
SciCan Statim Helix Device
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£140.00 – £260.00 VAT
Helix type test is an accepted method of testing the steam penetration and air removal capability of a vacuum steriliser.
SciCan Statim Process Challenge Device & Test Strips are:
- Easy to use – Can be used with minimal training.
- Simple – Visual reading of colour change and interpretation of results.
- Manufacturer Specific – For the Type S Statim 2000S and 5000S only (not suitable for extended cassette machines).