Spinoscope (BIoportal)

1. Rigid Spinoscope description
ABLEYE rigid Rigid Spinoscopes are used for illumination and visualization for diagnostic and therapeutic endoscopic surgical procedures in the following areas; Arthroscopy, Spinal surgery, Spine endoscopy surgery.

2. Rigid Spinoscope Model applicable
5943.0207、6943.0180、SQUEEN 5、SQUEEN 6、8457.0120、8457.0157、SQUEEN 8、SQUEEN 8.5、HT730-0417UB、HT730-0417UB12、HT730-0417UB30

3. Preparation for use

1. Ensure that the proximal end of the Rigid Spinoscope is dry to prevent the Rigid Spinoscope from fogging up during the procedure.
2. Ensure that there are no residual cleaning agents or disinfectants on the Rigid Spinoscope.
3. Inspect distal end, proximal end and irradiation surface of the illumination fibers for contamination and scratches. Make contaminants and scratches visible using light reflexes. Hold the connection of the optical fibers against the light and inspect whether the optical fibers illuminate evenly at the distal end.
4. Check image quality: The image may not be blurry, clouded or dark. If necessary, remove deposits on the optical end surface.

4. Use

1. Connect Rigid Spinoscope:
   a. Connect light cable. If necessary, mount adapter for light cable. (see. Fig 1)
   b. Connect camera
2. Make sure the distal end of scope emits light. If necessary, adjust light intensity by rotating knob for brighter intensity.

WARNING
RISK OF BURNS!
The optical fibers emit high-energy light at the distal end of the Rigid Spinoscope. This can cause the temperature of the body tissue to rise to 41℃.
➔ Avoid direct contact of the distal end with body tissue or flammable materials as it can cause burns.
➔ Reduce the light intensity of the cold light source when working near body tissue or flammable materials.
③ Prepare the Rigid Spinoscope for reprocessing immediately after use to prevent drying of the contaminants.

5. Reprocessing
CAUTION
◈ When choosing the cleaning agent and disinfectant ensure:
→ That these are basically suitable for the cleaning and disinfection of instruments made of metals and plastics
→ That a disinfectant with proven efficacy (FDA approval or CE mark) is used and that it is compatible with the cleaning agent
→ That chemicals used are compatible with the instruments
◈ Combined cleaning / disinfecting agents should not be used if possible. Only in cases of very low contamination (no visible impurities) can combine cleaning / disinfecting agents are use.
◈ Cleaning and disinfectant concentrations and contact times which are specified by the manufacturer must be strictly adhered.

  5.1 Cleaning

1. After disconnection of the adaptors and protective cap from the Rigid Spinoscope, rinse the products at least 1 minute under running water.
2. Brushing the working channel with a brush at least 10 time from proximal to distal end. Rinse with water using a disposable syringe 50ml at least 5 times.
3. Rinse irrigation channels with water using a disposable syringe 10ml at least 10 times.
4. Prepare the cidezyme concentration at the concentration specified by the manufacturer, wipe the surface of the Rigid Spinoscope several times with a cloth soaked in cidezyme. Immerse it in cidezyme for at least 10 minutes (In case of working and irrigation channels, fill the solutions in using a disposable syringe.) and then clean it for 5 minutes by using ultrasonic.
5. Immerse the Rigid Spinoscope and adaptors in the cleaning solutions and wipe the working channel and surface of product using soft brush. In case of irrigation channels, rinsing using a disposable syringe 10ml at least 5 times.
6. Rinse the Rigid Spinoscopes with sterile, deionized water for 5 minutes. In case of working and irrigation channels, rinsing using a disposable syringe.

5.2 Disinfection

1. Immerse the Rigid Spinoscopes in the disinfectant solution (Cidex OPA) for 15 minutes. Using a disposable syringe, fill the solutions the working channel and irrigation channels in.
2. Immerse the Rigid Spinoscopes and adaptors in the disinfection solutions and swab the working channel and surface of product using soft brush. In case of irrigation channels, rinsing using a disposable syringe 10ml at least 5 times
3. Rinse the Rigid Spinoscopes with sterile, deionized water for 5 minutes. In case of working and irrigation channels, rinsing using a disposable syringe.
4. Wipe off moisture with a clean dust-free adsorbent. if necessary, remove any remaining moisture with an air gun.

Ethylene Oxide (ETO) Gas Sterilization

1. Place the Rigid Spinoscopes in a sterilization try.
2. Wrap with cleared polypropylene wrap (tyvek for medical device sterilization).
3. Sterilize using the following parameters;

4. Store sterile Rigid Spinoscopes in their original packaging until use. Incorrect storage may lead to loss of sterility.

Steam Sterilization

1. Place the Rigid Spinoscopes marked “autoclave” in a sterilization tray.
2. Sterilize using the following parameters;

3. During sterilization, Rigid Spinoscopes should not come into direct contact with metal.

4. Sudden changes in temperature may fracture the glass components of Rigid Spinoscopes. Do not immediately expose Rigid Spinoscopesto air after removal from the autoclave.

5. Store sterile Rigid Spinoscopes in their original packaging until use. Incorrect storage may lead to loss of sterility.

6. Caution

1. Read the instruction for use thoroughly before use.
2. These Rigid Spinoscopes may only be used by licensed physicians and qualified medical personnel who have been trained in their use.
3. The Rigid Spinoscopes are provided NON-STERILE, and must be thoroughly cleaned and sterilized according to validated infection control procedures prior to the initial use and before each subsequent use.
4. Refer to the instruction for use of the products used in combination with these instruments.
5. The Rigid Spinoscope must be checked before and after every use, where the performance is ok and the Rigid Spinoscope has no damage.
6. Do not attempt to do any repairs yourself.