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DCO-0599 

Effective Date: 14-DEC-2018 

 

LBL-6025 Rev B 

Page  3 of 8 

 

 

1)

 

  Concentration levels specified by the manufacturer of 

the detergent must be strictly adhered to.  Contact times 

specified in these instructions for use must be strictly 

adhered to.  Use only freshly prepared solutions. 

2)

 

  Do not soak the handpiece in Isopropyl Alcohol or other 

corrosive liquids that may not be compatible with the 

instrument. 

3)

 

  Always use fresh volumes of water for rinsing.  Do not 

reuse rinsing water for rinsing or any other purpose. 

10.1.

 

CLEANING INSTRUCTIONS 

Proper cleaning must be performed prior to sterilization.  An effective 

cleaning process is essential to ensure effective sterilization.  
Clean the handpiece as soon as possible after use.   
If it is not possible to clean/rinse the handpiece immediately following a 

procedure, the instrument should be placed in a basin with clean 

lukewarm tap water until proper cleaning can be commenced per the 

instructions below. 

Cleaning Agent:  

Use ENZOL® or an equivalent neutral pH enzymatic detergent. 

Enzymatic detergents aid in the removal of organic soil such as blood. 

Cleaning the Handpiece:

 

1)

 

Disassemble the handpiece 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 connector, it could damage the connector. 

3)

 

Gently and thoroughly rinse the handpiece under running 

lukewarm tap water 72° - 109°F (22° - 43°C) for a minimum of 2 

minutes, flushing water through all passages. 

 

4)

 

Lay the handpiece horizontally in a clean pan. 

 

5)

 

Prepare the cleaning solution, enzymatic neutral pH cleaner 

(ENZOL® or equivalent), in accordance with the concentration 

defined by the manufacturer of the detergent.  

6)

 

Add a sufficient amount of the prepared cleaning solution to the 

pan to completely cover the handpiece. 

Caution 

 

Do not immerse the handpiece when it is hot. This may 

damage the handpiece. 

7)

 

Soak the handpiece for a minimum of 10 minutes.  Move the 

handpiece back and forth 5 times to ensure that all surfaces are 

exposed to cleaning solution.  This will reduce blood, protein, and 

mucus from the instrument. 

8)

 

Flush the cavity and lumens of the instrument 5 times with 

minimum 25mL volume of cleaning solution using a disposable 

syringe.  

 

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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