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DCO-0599 

Effective Date: 14-DEC-2018 

 

LBL-6025 Rev B 

Page  4 of 8 

 

 

9)

 

Scrub the Shaver Blade/RF Probe Cavity using the Shaver Blade 

Cavity cleaning brush for a minimum of 1 minute. 

 

10)

 

Scrub the Motor Shaft using the Motor Shaft cleaning brush for a 

minimum of 1 minute. 

 

11)

 

Scrub the Fluid Channel using the Fluid Channel cleaning brush 

for a minimum of 1 minute. 

 

12)

 

Ensure that all interior surfaces, crevices, lumens, cavities, and 

holes of the handpiece are scrubbed thoroughly to remove any 

visible debris.  

13)

 

Scrub the exterior surface of the handpiece with a gauze pad 

soaked in the cleaning solution for a minimum of 1 minute. 

 

 

14)

 

Remove the handpiece from the cleaning bath and rinse it 

thoroughly, flushing the interior lumens and cavities, for a 

minimum of 2 minutes under running lukewarm tap water 72° - 

109°F (22° - 43°C).   

 

Cleaning Verification 

15)

 

After cleaning, inspect the handpiece under normal lighting to 

ensure that all visible debris has been removed. 

16)

 

If not visibly clean, repeat cleaning and re-inspect. 

17)

 

For difficult-to-view areas, 3% hydrogen peroxide may be applied 

(bubbling is evidence of the presence of blood). 

Note

: Rinse the handpiece thoroughly under running lukewarm 

tap water 72° - 109°F (22° - 43°C) following any hydrogen 

peroxide testing. 

18)

 

Shake the handpiece with the shaver blade cavity end pointing 

downward to remove any water. 

19)

 

Dry the handpiece with a lint-free towel. 

Note

: Compressed air or nitrogen may be used to remove any 

additional moisture from the handpiece. 

10.2.

 

STERILIZATION

 

INSTRUCTIONS 

Clean and sterilize the handpiece prior to the first use and every use 

thereafter. 

Caution 

 

Never sterilize the handpiece that has not been cleaned.  

The success of the sterilization process depends on the 

previous state of cleaning. 

Caution 

 

Always install the soaking cap prior to cleaning or 

sterilization.  If moisture reaches the connection pins of 

the cable connector, it could damage the connector. 

Caution 

 

The handpiece can be sterilized by using the following 

methods only. 

Sterilizing the Handpiece:

 

1)

 

Clean the handpiece according to the “Cleaning Instructions” 

section of this manual. 

2)

 

Attach the soaking cap to the cable connector if it is not already 

attached. 

Caution 

 

Do not cross-sterilize the handpiece.  Alternating 

between different methods of sterilization may cause 

undue wear on the handpiece.  Product longevity is 

extended by the consistent use of a single sterilization 

method. 

Caution 

 

Remove the handpiece from the sterilizer immediately 

after sterilization, or product damage may result. 

Caution 

 

Never immerse the handpiece in a liquid to help it cool 

after sterilization, or product damage may result.  If 

necessary, cool the handpiece by wrapping it in a 

sterilized damp sponge or cloth. 

3)

 

Prepare the handpiece for sterilization by either:  

a) Wrapping the handpiece in Kimberly-Clark Kimguard KC400 

Sterilization Wrap or equivalent 

b) Following the steps below if the optional Sterilization Tray is to 

be used. 

4)

 

Place the handpiece into the optional Sterilization Tray as shown 

in the figure below.  Ensure that the handpiece is snapped into 

the rubber holders. 

Содержание R-10002

Страница 1: ...asis of blood vessels through its shaver blade and probe Examples of uses of the product include resection of torn knee cartilage subacromial decompression and resection of synovial tissue in other joints Contraindications The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants 4 CONTR...

Страница 2: ...ssory or device be sure to follow the instructions provided with the accessory or device 7 HOW SUPPLIED Warning The Tricera Handpiece is supplied non sterile It must be cleaned and sterilized before the first use Prior to each subsequent use it must be cleaned and sterilized The shipping box contains 1 ea Relign Tricera Handpiece 1 ea Shaver Blade RF Probe Cavity Brush Gordon Brush PN 721012 or eq...

Страница 3: ...ece from the other system components a Remove the shaver blade RF probe from the handpiece b Dispose of all used shaver blades RF probes according to hospital regulations c Disconnect the handpiece from the Relign Controller 2 Attach the soaking cap to the cable connector Caution Always install the soaking cap prior to cleaning or sterilization If moisture reaches the connection pins of the cable ...

Страница 4: ...ny additional moisture from the handpiece 10 2 STERILIZATION INSTRUCTIONS Clean and sterilize the handpiece prior to the first use and every use thereafter Caution Never sterilize the handpiece that has not been cleaned The success of the sterilization process depends on the previous state of cleaning Caution Always install the soaking cap prior to cleaning or sterilization If moisture reaches the...

Страница 5: ...ade in a sterile irrigant and activate suction while testing the handpiece 2 Run the handpiece through its various functions modes and settings to ensure it responds properly to commands Ensure that all parts move freely and that there are no loose or missing components Note any unusual sounds or vibrations and note operating speeds 3 Refer any calibration or operating difficulties to your Relign ...

Страница 6: ... term original purchaser as used in this warranty means that person or organization and its employees if applicable to whom the Tricera Handpiece was sold by Relign This warranty may not be assigned or transferred in any manner In order to make a warranty claim the original customer must obtain a Return Materials Authorization Number RMA Number and return instructions from Relign s Customer Servic...

Страница 7: ...era Handpiece 1 Shaver Blade RF Probe Cavity Brush Gordon Brush PN 721012 or equivalent 2 Fluid Channel Brush Key Surgical PN AT 12 197 or equivalent 3 Motor Shaft Brush Gordon Brush PN 499NAD ST or equivalent Figure A3 Cleaning Brushes 1 Sterilization Tray 2 Sterilization Tray Lid 3 Rubber Holders Figure A4 Optional Sterilization Tray if available 1 2 3 1 Shaver Blade Cavity 2 Motor shaft 3 Fluid...

Страница 8: ...The shaver blade does not turn The shaver blade is not inserted properly Remove the blade and reinsert it according to the Relign Tricera System instructions for directions on use of the Tricera Handpiece as part of the Relign Tricera System The handpiece will not run The handpiece is not properly connected to the controller Remove and reconnect the handpiece cable to the controller according to t...

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