Electrosurgical system electrode, foot-controlled, single use (T-Saurus)

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Description
T-SAURUS electrodes are used for nucleoplasty by ablating the tissue of the herniated disc. It is intended to be used in the following indication; Radicular Pain, Discogenic Pain. Also, it is intended to be used in following application area; Lumbar disc.

Key Features

  • Single-use sterile electrode
  • Foot-controlled operation
  • Precise cutting and coagulation
  • Minimizes thermal damage
  • Compatible with the T-Saurus Electrosurgical System

Manufacturer: Techcord Co., Ltd/ Korea

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Description
T-SAURUS electrodes are used for nucleoplasty by ablating the tissue of the herniated disc. It is intended to be used in the following indication; Radicular Pain, Discogenic Pain. Also, it is intended to be used in following application area; Lumbar disc.

Product Information

  1. Product name: Electrosurgical system electrode, foot-controlled, single-use
  2. Trade Name: T-SAURUS
  3. Model Name: TSR-150, TSR-250, TSR-310, TSR-360, TSR-390

Preparation for use

  1. This product should be used by trained doctors only for this procedure.
  2. Prior to use, ensure all package inserts, warnings, cautions, procedure technique manual, and instructions for use are read and understood.
  3. Ensure that the manipulator cable is properly connected to the electrode.
  4. Use only after checking the power is properly generated by self-diagnosis.
  5. Use this device in the safe area for medical procedure as it is connected to the RF generator.
  6. This device is sterilized packed so it should be used after checking this shelf life.
  7. If any problem occurs, stop using the product immediately and contact the manufacturer.

Use

  1. Connect the manipulator to RF Generator.
  2. Monitor the nerve root stimulation after local anesthesia.
  3. Insert the puncture needle to the target lesion.
  4. Check the right targeting of puncture needle through C-arm and remove the Stylet.
  5. Insert the electrode in the puncture needle and access to the target lesion.
  6. Check if the electrode access to the target lesion with C-arm before activating the electrode.
  7. Generate the power by turning on the RF generator and pushing foot switch.
  8. Stop the procedure if the patient complains acute pain.
  9. Remove the electrode and puncture needle after procedure.
  10. Follow standard procedure for skin disinfection and sterile dressing.
  11. Scrap after use as this electrode is single use.

Caution

  1. This product is sterilized so keep sterilized during procedure and do not use after shelf life.
  2. DO NOT touch or operated this product with wet hand as it uses electricity.
  3. DO NOT use if this package is damaged or foreign material is got into.
  4. DO NOT connect with other equipment other than RF generator.
  5. Electrode is supplied sterile and is intended for SINGLE USE ONLY. DO NOT re-sterilize, or reuse which can lead damage or degraded performance of the device, resulting in product malfunction, failure, or patient infection and inflammation.

Contraindication

  1. Patient with cardiac pacemaker or other electric implant.
  2. Lactating or pregnancy woman.
  3. Previously operated discs where integrity of annulus has been compromised by an annulotomy.
  4. Severely degenerated discs with less than 50% of normal disc height.
  5. Discs with metallic fusion implant at an adjacent disc level.
  6. Annulus herniations with free disc fragments.
  7. Patients with spinal infections, disease, or severe osteoarthritis.
  8. Patients with bony deformities such as spondylolisthesis, hermivertebrae, or severe congenital abnormalities.

Side effect

  • Musclecontraction
  • Epiduralfibrosis
  • Thermal damage on the tissue
  • Localanaestheticrelatedsideeffects
  • Edema of the prevertebral soft tissue
  • Infection
  • Annulusfibrosusdamage
  • Soreness at the Needle site, new numbness and tingling
  • Disc generation from lowered disc height due to excessive ablation
  • Infectiousdiskitis
  • Nerve root trauma
  • Vascularinjury
  • Vertebralendplatedamage ∙ Patient’s intense pain
  • Nerve damage

Operating environment

  1. Ambient temperature range: 10°C to 40°C
  2. Relative humidity: 20% to 70%
  3. Atmospheric pressure: 70 to 106 kPa

Storage condition

  1. Store packing with Tyvek and A-PET
  2. Ambient temperature range: 10°C to 40°C
  3. Relative humidity: 20% to 70%
  4. Atmospheric pressure: 70 to 106 kPa

Shelf Life

  1. 2 year from the date of E.O Gas Sterilization.
  2. DO NOT USE after shelf life specified on the label.

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