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INSTRUCTIONS FOR USE

Indications for Use

The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the

following STERRAD

Sterilization Systems:

• STERRAD

100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology

• STERRAD NX

(STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology

• STERRAD

100S

Background Information

The STERRAD VELOCITY™ Biological Indicator (BI) is a rapid biological indicator designed for frequent monitoring and periodic testing of STERRAD

Sterilization Cycles which use hydrogen peroxide

as the sterilant. The STERRAD VELOCITY™ Biological Indicator used in conjunction with the STERRAD VELOCITY™ Reader (Reader) provides a fast and reliable way to verify the effectiveness of the

STERRAD

Sterilization Cycle. The STERRAD VELOCITY™ BI is for use in STERRAD

Sterilizers only. A certificate of performance is available at www.bi.aspjj.com.

The STERRAD VELOCITY™ BI contains a spore disc which carries over one million

Geobacillus stearothermophilus

[ATCC 7953] spores. These spores have been

identified as the most resistant known organism for challenging hydrogen peroxide based sterilization systems. The BI also contains a glass ampoule filled with

liquid growth medium designed to promote the growth of

G. stearothermophilus

. These components are contained in a clear plastic vial with a vented cap. The

cap is designed with sterilant ingress windows which allow sterilant to enter the vial during the sterilization process, and then seal when activated for reading. A

chemical indicator (CI) on the top of the cap changes color from red/pink to yellow when exposed to hydrogen peroxide. A cutaway illustration of the BI indicating

its various parts is shown in Figure 1.

The α-glucosidase enzyme is generated naturally during growth of

G. stearothermophilus

and released during spore germination. The α-glucosidase enzyme

in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate, 4-methylumbelliferyl

α-D-glucoside (MUG). The resultant fluorescent by-product, 4-methylumbelliferone (MU), is detected in the reader. The fluorescent signal is used to

determine the positive or negative result of the biological indicator.

In the event that the STERRAD VELOCITY™ Reader is unavailable, it is also possible to detect the presence of

G. stearothermophilus

spore growth visually (see

Optional Visual Interpretation section below). Substances produced by the surviving spores react with chemicals in the growth medium changing the color of

the liquid from purple to yellow. This detection method is optional and not intended for everyday use. When using this method the biological indicator must be

cultured in an incubator at 55-60°C (131-140°F) for 5 to 7 days to get final visual results.

Readout Times

The STERRAD VELOCITY™ Reader automatically reads the STERRAD VELOCITY™ BI to obtain a final (positive or negative) fluorescent result associated with spores within 30 minutes.

Precautions

• As a precaution, when handling biological indicators that have been exposed to hydrogen peroxide, please wear the appropriate PPE (chemical resistant latex, PVC/vinyl, or nitrile gloves). Refer to

the glove manufacturer’s instructions for use for more information.

• If the ampoule breaks during the sterilization cycle the BI result is invalid. Process a subsequent load with another BI.

• Use only STERRAD

SEALSURE

Tape, 5 to 10 cm (2 to 4 in), if applying tape to secure the BI to the load. Any other tape may be fluorescent and interfere with the fluorescence detection causing

misleading results.

• DO NOT place the BI in the pouch with the load during the sterilization cycle.

• DO NOT apply tape or labels to the BI cap prior to processing in the STERRAD

Sterilization System. The tape will block the sterilant ingress windows causing misleading results.

• Remove any tape from the growth reservoir prior to placing the BI in the Reader. The tape will obstruct the fluorescence detection causing misleading results.

• Only use a STERRAD VELOCITY™ BI in the sterilization cycles listed in Indications for Use.

• The BI is fragile, handle with care.

• Make sure the growth medium fills the growth reservoir, and there are no large bubbles present.

• The BI is single use only and will not function properly if reused. Should a cycle cancellation occur, use a new BI when restarting the cycle.

• DO NOT place marks on the barcode or sterilant ingress windows. Placing marks on the barcode may interfere with the barcode reader’s ability to retrieve barcode data. Placing marks on the

sterilant ingress windows could puncture the label material.

• Do not use a STERRAD VELOCITY™ BI beyond the expiration date printed on the package.

Positive Control BI Instructions

A positive control is an unprocessed STERRAD VELOCITY™ BI which is activated and read in the STERRAD VELOCITY™ Reader. The positive control ensures that the BI and the Reader are functioning

properly.

1. Select a positive control BI from the same lot as the test BI.

2. Inspect the positive control to ensure the growth medium is purple, the ampoule is intact, the CI on the cap is red/pink, and the spore disc is lying horizontally in the bottom

of the growth reservoir.

Note: Space has been provided for recording the sterilizer ID, load ID, and date on the cap label.

3. Touch an available well indicator number on the reader’s touch screen.

4. Touch “Control” when asked what type of BI will be added.

5. Scan the barcode on the cap label using the barcode scanner on the front of the Reader.

6. Enter the operator’s name in the space provided or select the operator’s name from the list.

7. Activate the BI before placing it in the reader. To activate, completely press cap down until the glass ampoule breaks and visually inspect to ensure the glass ampoule has

broken. Shake rapidly to ensure liquid flows into the growth reservoir (See Figure 2). Failure to do so may result in incorrect reading.

8. Place the control BI in the selected Reader well. Test results will be available within 30 minutes.

Test BI Instructions

A test BI is a BI which is processed in a STERRAD

Sterilization Cycle.

1. Inspect the test BI to ensure the growth medium is purple, the ampoule is intact, the CI on the cap is red/pink, and the spore disc is lying horizontally in the bottom of the growth reservoir.

Note: DO NOT apply tape or labels to the BI cap prior to sterilization or the growth reservoir prior to reading.

Note: Space has been provided for recording the sterilizer ID, load ID, and date on the cap label.

2. If the STERRAD

Sterilizer is equipped with a scanner, scan the BI barcode on the cap label.

3. For the STERRAD NX

and the STERRAD

100NX, place the BI on the bottom shelf close to the rear of the sterilization chamber.

For the STERRAD

100S, place the BI in the bottom close to the front of the sterilization chamber.

4. Once the cycle completes put on protective gloves and remove the BI from the sterilizer.

Note: The BI must be placed in the Reader within 2 hours of completing the sterilization cycle.

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