Biological Monitoring And Verification Device

This product consists of a compartment loaded with biological indicators, polytetrafluoroethylene hoses with an inner diameter of 1mm and a length of 1m at each end, plastic discs, sealing rubber rings, etc. It needs to be used in conjunction with our company's rapid biological indicators to represent the sterilization effect inside the luminal instruments. After sterilization, if the biological indicator in the cabin is negative and the biological indicator in the positive control is positive, it indicates that the sterilization is qualified.

Scope And Method Of Use

Scope of use

Used in conjunction with biological indicators for monitoring sterilization effectiveness.

Usage method

1. Record the necessary items for sterilization management (such as sterilization treatment date, operator, etc.) in the label blank space on the surface of the biological indicator.

2. Unscrew the cover of the biological indicator compartment, place the cover downwards into the biological indicator compartment, screw on the compartment cover, and fix the compartment on the plastic tray. Then place it in a difficult sterilization position of the sterilizer and run the sterilization program.

3. After sterilization, remove the biological indicator from this product. Press down on the indicator cover to close the ventilation hole on the side of the cover. Use the dedicated card slot on the rapid biological reader to squeeze the indicator plastic tube, causing the glass tube inside the plastic tube to break. Confirm that the bacterial slide is completely immersed in the culture medium and insert it into the rapid biological reader for cultivation.

4. Take another unsterilized biological indicator of the same batch number, press down on the indicator cover to seal the side vent hole of the cover, use the dedicated card slot on the rapid biological reader to squeeze the indicator plastic tube, break the glass tube inside the plastic tube, confirm that the bacterial slide is completely immersed in the culture medium, and use it as a positive control for simultaneous cultivation in the rapid biological reader. For biological indicators used for cultivation testing, the culture medium ampoule tube should be crushed and placed in a reader for cultivation within 2 minutes.

5. The detection time of the rapid biological indicator in the rapid biological reader is 20 minutes. If the color change of the recovery medium needs to be observed, it needs to be further cultured for 48 hours.

6. On each day of culturing sterilized biological indicators, activate and cultivate at least one non sterilized biological indicator of the same batch as a positive control.

Result Judgment

Fluorescence detection result judgment

1. For sterilized biological indicators, a fluorescence positive (red light or+) indicates that the sterilization is not qualified.

2. For sterilized biological indicators, a fluorescence negative (green light or one) indicates that the sterilization is qualified.

3. The positive control must show a fluorescent positive result for this biological test to be valid.

Determination of biological testing results

1. For sterilized biological indicators, a biological positive (the color of the culture medium changes from purple to yellow) indicates that the sterilization is not qualified.

2. For sterilized biological indicators, a biological negative (with no change in the color of the culture medium) indicates that the sterilization is qualified.

3. The positive control must show a biological positive result for this biological test to be valid.

Product Specifications

1 piece/box

Usage Period

One year from the date of production

Storage Conditions

Please store at a temperature of 4 ℃~30 ℃, relative humidity ≤ 50%, away from sterilizers and other chemicals, avoid sunlight and ultraviolet radiation, and do not freeze.

Matters Needing Attention

1. This product is reusable and has a lifespan of 50 sterilization cycles. Exceeding the lifespan may result in incorrect monitoring results due to sealing or other issues.

2. This product must be intact, clean, and dry before use. If it is damaged or contaminated, do not use it.

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