Straightshot M4 and M5 Microdebrider Cleaning and Sterilisation Instructions July 2016

StraightShot M5 Microdebrider ™

STRAIGHTSHOT M4/M5 MICRODEBRIDER CLEANING AND STERILISATION INSTRUCTIONS ™

THUMBWHEEL COLLET

LOCK LEVER

PROPER CLEANING IS KEY STEP 1 – CLEANING (MANUAL OR AUTOMATED) MANUAL CLEANING 1.

Disconnect the power before cleaning.

2.

 o not fully immerse, or ultrasonically clean, this D instrument.

3.

 emove the blade or bur, suction and irrigation R tubing from the handpiece; other disassembly is not required.

A

4.

B

D

Manually rinse the microdebrider, cable, and tubing management clips with running tap water to remove all visible soil from the device. Hold the microdebrider with collet end down when rinsing and run a stream of water through the suction port. (Figure A).

5.

Using a soft cloth dampened with neutral enzymatic detergent, wipe the motor and cable. (Figure B).

6.

Gently clean the microdebrider, cable, and tubing management clips with a soft bristle brush. (Figure C).

Using a nylon twisted brush and enzymatic detergent, gently and thoroughly clean the entire open lumen of the device. (recommended use of 7mm diameter brush) (Figure D).

8.

Repeat Step 4.

9.

Run a steady stream of warm water into the collet and into lock lever. Actuate the collet and turn the thumbwheel for several rotations while rinsing under running water. Shake excess water from the microdebrider. (Figure E).

10. Shake excess water from the microdebrider. Dry the microdebrider, cable, and tubing management clips with a lint-free towel. (Figure F).

E

C

7.

F

AUTOMATED CLEANING 1.

2.

3.

 anually rinse the handpiece, cable, and tubing management clips with M running tap water to remove all visible soil from the device. Using a soft bristled brush and a neutral detergent solution, gently and thoroughly clean the entire open lumen of the device.

Wash (Neutral Enzymatic OR Alkaline Detergent)

Pre-Wash Minimum Time

Actuate the collet while rinsing and turn the thumbwheel. Hold the handpiece with collet end down when rinsing and run stream of water through the suction port.  emove devices from instrument trays before placing into washer baskets. R Place devices in the washer with the collet facing downward to facilitate drainage.

Temperature & Detergent Type and Concentration

2 minutes

Cold tap water

5 minutes

10 minutes

Neutral Enzymatic Detergent

Alkaline Detergent

< 50°C

66°C (set point)

neutral pH enzymatic alkaline detergent detergent, manufacturer’s pH ≤ 10.5 recommended concentration

Rinse

Thermal rinse

1 minute

1 minute

Hot tap water

82°C minimum

STEP 2 – STERILISATION STERILISATION StraightShot M4 and M5 Microdebriders were validated using the STERRAD NX System standard cycle. Immediate Use Steam Sterilisation (IUSS), or “flashing”, is not recommended for Straightshot Microdebriders M4 and M5. Sterility for microdebriders M4 and M5 cannot be assured when processed using IUSS. ™

®

®

™

Steam Autoclave/Gravity (Choose one)

Steam Autoclave/Pre-Vacuum (Choose one)

Minimum Temperature

Minimum Cycle Time

Minimum Dry Time

1

121°C (250°F)

40 minutes*

25 minutes, or until visibly dry

2

132°C (270°F)

15 minutes

25 minutes, or until visibly dry

1

132°C (270°F)

4 minutes

25 minutes, or until visibly dry

2

134°C (273°F)

18 minutes

25 minutes, or until visibly dry

3

134°C (273°F)

3 minutes

25 minutes, or until visibly dry

Packaging

Storage

For sterilisation, place devices in instrument tray. Instrument tray should be wrapped with up to two layers of 1-ply polypropylene wrap.

It is extremely important that the handpiece be rapidly and completely vacuum-dried before storage to prevent corrosion and residue deposits in the bearing and motor.

* This 40 minutes and 121°C gravity sterilisation cycle is not considered by the United States Food and Drug Administration (US FDA) to be a standard sterilisation cycle. Users should only use sterilisers and accessories (such as sterilisation wraps, sterilisation pouches, chemical indicators, biological indicators, and sterilisation containers) that have been cleared by the US FDA for the selected sterilisation cycle specifications (40 minutes and 121°C).

Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions, and contraindications.

Medtronic Australasia Pty Ltd. 97 Waterloo Rd, North Ryde NSW 2113. P:1800 668 670. www.medtronic.com.au ©2016 Medtronic. All rights reserved. UC201600281aEN ANZ 3263-072016