Instructions For Use

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Specializing in Patella Instruments

Instructions for Use

General Instructions:

CW Logics specializes in orthopedic patella instruments used during primary and revision total knee procedures.  These products are only to be used by adequately trained and qualified personnel.  See surgical techniques and product descriptions for more information located at www.cwlogics.com.

There are two classifications of instruments addressed in this manual:  clamps (single use only) and reusable instruments.

 

A.  ProClamp and SpeedClamp – Single Use Only

The ProClamp is designed to protect the resected patella and acts as a novel outside patella retractor when used with a ProRetract retractor.  There are two sizing options — 40mm (Catalog Number 3002) and 50mm (Catalog Number 3001).  These two ProClamps come in a sealed clear plastic package and are further protected with bubble wrap.  They are labeled as 40mm and 50mm respectively.   Both of these are non-sterile and need to go through standard cleaning, inspection and steam sterilization described below.

The SpeedClamp is designed to protect and compress the patella implant to the resected patella and acts as a novel outside patella retractor when used with a ProRetract retractor.  There are two sizing options – Standard (Catalog Number 1001) and Tall (Catalog Number 1002).  These two SpeedClamps come in sealed clear plastic package and are further protected with bubble wrap.  They are labeled as Standard and Tall respectively.   Both of these are non-sterile and need to go through standard cleaning, inspection and steam sterilization described below.

 

  1. Warnings and Precautions

 

All hospital personnel that work with contaminated or potentially contaminated instruments should use general precautions when handling these instruments.

*WARNING* The metal spike on the underside of the Standard and Tall SpeedClamp and the 40mm and 50mm ProClamp is sharp and hidden from view at certain angles.  Identify this spike and be careful not run your finger across it.  You can cut your glove and/or your finger on this metal spike.  This applies to sterile processing as well as O.R. personnel.

*WARNING* –  Do not attempt to reuse either the Standard or the Tall SpeedClamp or the 40mm or 50mm ProClamp.  The SpeedClamp and the ProClamp are a single use only instrument.  Contaminants may get under the Santoprene overmold of the SpeedClamp and cannot be accessed for cleaning after O.R. use without damaging the Santoprene overmold.  Also, after use in the O.R., contaminants, including bone, may remain in between the spike and the backfold of both the SpeedClamps and the ProClamps and it is difficult to clean appropriately because of the lack of access and the lack of visibility for inspection in this area.  The compressive force created by the bend in the spring steel is not designed to maintain the same compressive ability and stability on the patella after a single use.

2.  Cleaning Instructions

The ProClamps and SpeedClamps have been cleaned and passivated before packaging.  Further cleaning using manual and automated cleaning processes as described below in Section B2 are recommended prior to sterilization.

3.  Inspection

When taking ProClamps and SpeedClamps out of the plastic packaging and bubble wrap, inspect them make sure no packaging materials remains and confirm the instruments have not been damaged during shipping.

4.  Sterilization Instructions

Sterilization parameters are as follows:

Sterilizer Type:  Prevacuum

Preconditioning Pulses:  4

Minimum Temperature:  132 Degrees C

Full Cycle Time:  4 minutes

Minimum Dry Time:  30 minutes

Article Configuration:  ProClamp 50mm (Catalog No. 3001) and 40mm (Catalog No. 3002) and SpeedClamp Standard (Catalog No. 1001) and Tall (Catalog No. 1002) either double wrapped in 1-ply polypropylene wrap or individually single packed in self-sealed pouch.

Sterilization pouch or wrap should be medical grade and conform to the recommended specifications for the above steam sterilization.   Ensure that the pouch or wrap is large enough to contain the device without stressing the seals or tearing the pouch or wrap. 

5.  Storage Instructions

Sterile packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/humidity extremes.

Sterile instrument packages should be carefully examined prior to opening to the sterile field to ensure that package integrity has not been compromised.  If the packaging shows any evidence of tampering or has been exposed to moisture, the instrument must be cleaned, repackaged and sterilized.

 

B.  ProRetract retractors and Applicator — Reusable

The ProRetract N style (Catalog Number 8001) and U style (Catalog Number 8002) retractors, as well as the Applicator (Catalog Number 2001), are designed to be reused.   All hospital personnel that work with contaminated or potentially contaminated instruments should use general precautions when handling these instruments.

1.  Warnings and Precautions

When using for the first time, make sure any packaging materials are not left on the instruments, there is no damage from shipping and they are in good working order.

There will be minimal effect on these reusable instruments as they are made from stainless steel.  Normal wear and usage will eventually require instruments to be replaced.

 

2.  Cleaning Instructions

A manual or combination manual/automated cleaning process is recommended.

MANUAL CLEANING PROCEDURE

  1. Cleaning agents with neutral pH, enzymatic and alkaline (pH ≤12) with low foaming surfactants should be used during manual cleaning procedures.  Instruments should be soaked for 20 minutes.
  2. Remove from enzyme solution and thoroughly rinse with purified water (ultra-filter, RO DI and/or distilled) for a minimum of 3 minutes.
  3. Completely submerge instrument in neutral pH cleaning (detergent) solution and place in sonication unit for 10 minutes, preferably at 45-50 kHz.
  4. Rinse with purified water for at least 3 minutes or until there is no sign of blood or soil in the rinse stream or on the instrument.
  5. Repeat steps 1 though 4 above as needed.
  6. Dry with clean, absorbent, non-shedding wipe.

 

AUTOMATED CLEANING PROCEDURE

The instruments should be clean following the manual procedure above.  An automated washer/disinfector is not recommended as the sole cleaning method.  It can be used as a follow up method, but is not required.  If an automated washer/disinfector is used, use standard cleaning solutions and cleaning cycles.  The cleaning cycle should incorporate a final rinse at a temperature between 70 and 95 degrees C in order to make the drying easier.

OTHER GENERAL CLEANING INSTRUCTIONS

Manual scrubbing with nylon and soft bristled brushes should always be performed with the instrument below the surface of the cleaning solution.  Do not use metal brushes or scouring pads during manual cleaning as these materials may damage the instruments.

Cleaning agents must be completely rinsed from device surfaces to prevent accumulation of detergent residue.  Avoid using cleaning agents with chlorine or chloride as this can corrode the stainless steel instruments.

When cleaning the Applicator, remove the spring to clean inside the housing where the spring goes.  Clean the spring and then reassemble onto Applicator.  Confirm that the Applicator is in good working order.  If the Applicator’s moving action needs to be lubricated, use a water-soluble product such as Instrument Milk or equivalent lubricant that is intended for surgical instruments that can be cleaned and sterilized.

When preparing for reprocessing, remove excess body fluids, bone and/or tissue from instruments with a disposable, non-shedding wipe.  Place instruments in a basin of distilled water.  Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning.  You can soak the instruments in proteolytic enzyme or other cleaning solution to help prevent drying of materials on the instruments.

If stainless steel instruments are stained or corroded, an acidic anti-corrosion agent in an ultrasonic cleaner may be sufficient to remove surface deposits.  Care must be taken to thoroughly rinse acid from devices.  Once the acid is rinsed, process through the above manual and automated cleaning steps.

Hard water should be avoided for initial rinsing.  Purified water should be used for final rinsing to eliminate mineral deposits on instruments.

The instruments should be cleaned following the manual or manual/automated cleaning procedure outlined above.

 

3.  Inspection

Carefully inspect each instrument to ensure that all visible contamination have been removed and inspect for completeness, damage and/or excessive wear.  Check the moving action of the Applicator to ensure smooth operation throughout the range of motion.

 

4.  Sterilization Instructions

Sterilization parameters are as follows:

Sterilizer Type:  Prevacuum

Preconditioning Pulses:  4

Minimum Temperature:  132 Degrees C

Full Cycle Time:  4 minutes

Minimum Dry Time:  30 minutes

Article Configuration:  Applicator Catalog No. 2001, N Style ProRetract retractor Catalog No. 8001 and U style ProRetract retractor Catalog No. 8002 – Double wrapped in polypropylene wrap.

 

5.  Storage Instructions

Sterile packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/humidity extremes.

Sterile instrument packages should be carefully examined prior to opening onto the sterile field to ensure that package integrity has not been compromised.  If the packaging shows any evidence of tampering or has been exposed to moisture, the instrument must be cleaned, repackaged and sterilized.
CUSTOMER SERVICE INFORMATION

 

If needed, contact CW Logics at:

www.cwlogics.com

1-360-448-6307 phone

1-360-838-7312 fax

4800 NW Camas Meadows Drive, Suite 210

Camas, WA  98607