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CLEANING AND STERILIZATION GUIDE
TruClear™ System Handpiece
REPROCESSING INSTRUCTIONS
Preparation before cleaning:
Reprocessing Instructions for the Handpiece
1. Dispose of the tissue removal device(s) used during the procedure.
Caution The handpiece is provided nonsterile and must be cleaned and sterilized prior to use. Detergent solutions used shall be between pH neutral and mild alkaline (7.0 to 10.8) to ensure material compatibility. Limitations and restrictions on processing: Repeated processing at the listed parameters has minimal effect on Covidien™ reusable devices. Wear and damage due to use normally determine the end of instrument life.
2. Disconnect the handpiece cable from the front panel by pulling back the locking collar on the connector to disengage it from the control unit. Do not disconnect the cable from the handpiece. 3. Place the protective cap on the connector end of the cable. 4. Set the suction control lever to the fully open position.
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Initial treatment at the point of use: 1. Remove contamination - Remove excess soil on the handpiece with disposable wipes. CAUTION: Disposable wipes containing bleach shall not be used. - Flush the channels of the handpiece with warm tap/sterile water or with an enzymatic solution per the detergent label instructions. 2. Prepare for transportation - The handpiece should be cleaned thoroughly after every use to remove all traces of blood and surgical debris. Reprocess as soon as possible following use. If reprocessing of the handpiece cannot be performed immediately, cover the device with a moist towel or spray with an enzymatic solution per the detergent label instructions. - Transport per hospital procedures.
CLEANING INSTRUCTIONS NOTE: Perform the following manual or automatic cleaning instructions.
Manual cleaning 1. Set the suction control lever to the fully open position. Ensure the suction control lever remains open throughout the cleaning process. 2. Under 32-40°C (90-104°F) running tap water, rinse the handpiece to remove all blood and surgical debris. Ensure the water flows out through the device lumen/port when rinsing the open end of the handpiece.
3. Immerse the handpiece in a 32-40°C (90-104°F) pH neutral enzymatic bath diluted per the label instructions and soak for a minimum of 5 minutes up to 10 minutes.
- Scrub the exterior of the handpiece, including the cable, with a soft nylon bristle general instrument brush for 1-2 minutes.
- Steris Prolystica™* 2x Concentrate Enzymatic or an equivalent detergent may be used in accordance withits label instructions.
4. Perform the automatic cleaning cycles, following the recommendations in the table (right):
4. While the handpiece is immersed, prime the lumen/port with 30ml of detergent solution to ensure all air is removed.
Note: Attach the handpiece to the washer-disinfector MIS rack or equivalent, if available.
5. While the handpiece is immersed, scrub the device.
Note: Place the handpiece into the washer-disinfector in a manner that will protect them from unwanted motion or potential mechanical damage during the automatic wash cycle.
- With the suction control lever in the open position, insert the brush through the port and scrub the lumen for 30-60 seconds using a 5 mm soft nylon bristle brush. - Scrub the opening of the handpiece and inner lumen with a 5 mm brush soft nylon bristle bush for 30-60 seconds. Ensure the brush reaches in-between the inner and outer lumen.
Treatment Time (MM:SS)
Temperature
Chemical
Pre-Wash
01:00
Cold Tap Water
N/A
- Scrub the exterior of the handpiece, including the cable, with a soft nylon bristle general instrument brush for 1-2 minutes.
Wash
03:00
Hot Tap Water [150°F / 66°C]
Mild alkaline detergent diluted per the label instructions
6. Under 32-40°C (90-104°F) running tap water, rinse the handpiece for 1-2 minutes. Ensure the water flows out through the lumen/port when rinsing the open end of the handpiece.
Rinse
00:15
Hot Tap Water [110°F / 43°C]
N/A
Wash
02:00
Hot Tap Water [150°F / 66°C]
Mild alkaline detergent diluted per the label instructions
8. Dry the handpiece with medical grade compressed air (20-30 PSI).
Rinse
00:15
Hot Tap Water [110°F / 43°C]
N/A
9. Inspect the handpiece. If not visually clean, repeat the cleaning process from Step 3.
Thermal Rinse
01:00
Hot Purified Water heated to 180˚ F (82˚ C)
N/A
Dry
06:00
High Setting [heated to 194°F/ 90°C]
N/A
7. Rinse the handpiece under purified water for 30-60 seconds.
Automatic Cleaning 1. Set the suction control lever to the fully open position. Ensure the suction control lever remains open throughout the cleaning process.
Note: neodisher MediClean forte™* or an equivalent detergent may be used in accordance with its label instructions.
2. Under 32-40°C (90-104°F) running tap water, rinse the handpiece to remove all blood and surgical debris. Ensure the water flows out through the device lumen/port when rinsing the open end of the handpiece.
6. Inspect the handpiece. If not visually clean, repeat the cleaning process from Step 3.
Pre-sterilization disinfection (optional)
3. Under 32-40°C (90-104°F) running tap water, scrub the handpiece: - With the suction control lever in the open position, insert the brush through the port and scrub the lumenfor 30-60 seconds using a 5 mm soft nylon bristle brush. - Scrub the opening of the handpiece and inner lumen with a 5 mm brush soft nylon bristle bush for 30-60 seconds. Ensure the brush reaches in-between the inner and outer lumen.
© 2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together aretrademarks of Medtronic.™* Third party brands are trademarks of their respective owners.All other brands are trademarks of a Medtronic company. 04/2020 – US200299 – [WF# 3646847]
5. Dry the handpiece with medical grade compressed air (20-30 PSI).
Long Wharf Drive 555 New Haven, CT 06511
In facilities that require disinfection before sterilization, the thermal rinse cycle during the automatic cleaning process should be programmed for 1 minute at 90°C / 194°F.
FOR FURTHER INFORMATION If further information on this product is needed, contact Customer Service at +1 800 962 9888 in the U.S., or an authorized representative.
800.722.8772 508.261.8000
medtronic.com/truclear