Electrosurgical System electrode (Plasma electrode)

1. Description

A foot-operated electrode for use with electrosurgical units and medical electrocautery Devices, among other electrosurgical equipment. lt is disposable.

2. Product Information

1. Product name: Electrosurgical system electrode, foot-controlled, single-use
2. Model Name: TP14045HKS, TP14045AS, TP19040AS P25045AS, TP25090AS

3. Preparation for use

1. This product must only be used by trained medical personnel.
2. Before using this product, the user must thoroughly understand the user manual for the electrosurgical unit and the user instructions for the electrode.
3. Visually inspect the product for damage before use
4. Check for any damage to the packaging. Do not use products with damaged or pre-opened packaging due to potential secondary contamination that could harm the patient. Do not use as it may cause harm.
5. This product is sterile. Always check the expiration date before use.

4. Use

1. Ensure the electrosurgical unit is turned off.
2. Remove the electrode packaging and connect the electrode connector to the electrosurgical unit.
3. If a drainage tube is used, connect the tube to a separate suction device.
4. Turn on the electrosurgical unit and prepare the electrode.
5. After confirming the electrode is properly connected to the electrosurgical unit, press the foot switch to incise or coagulate human tissue. Adjust the output control button on the electrosurgical unit to set the desired power level.
6. After use, turn off the electrosurgical unit and disconnect the cable connected to the electrode.

5. Storage and Handling After Use

1. This product is a single-use medical device. Reuse is strictly prohibited. After use, dispose of it in accordance with regulations.

※ EO Gas Sterilization

• Place the disposable foot-controlled electrosurgical unit electrode into a sterilization pouch (medical-grade TYVEK sterilization paper) and seal it.

2. After sterilization, store in a lcation where sterility is maintained.

※ Moist Heat Sterilization

• Place the disposable foot-controlled electrosurgical electrodes in a sterilization pouch or sterilization basket (sold separaterly).

• After sterilization, store in a lcation where sterility is maintained.

6. Caution

1. The user manual included with this product does not replace the manual for the electrosurgical unit.
2. Do NOT use in the presence of flammable or explosive substances.
3. DO NOT use in environments with high oxygen concentrations.
4. Electrodes must be fully and securely mounted on the electrode holder.
5. Do NOT use on patients with factors that prevent proper use of this product.

7. Precautions for Use

1. Do not exceed the maximum output energy limit specified in the manual when using the product.
2. Always operate at the minimum power setting to achieve the desired treatment effect.
3. Minimize electrode usage time to reduce the risk of unintended treatment effect.
4. Do not activate the electrode when other instruments are nearby or in contact.
5. Reduce the risk of burns by ensuring electrodes are not activated when in an open connection state.
6. Set the power to a low level when treating small children.
7. Users must not modify this product.
8. This product is for single use only; reuse is prohibited.
9. Connecting this product to any device other than approved electrosurgical units or electrode cables designed for use with electrosurgical units may cause abnormal electrode output and may pose a risk to the patient and user.

8. General Precautions

1. Forcing the device into awkward positions or dropping it may cause damage to the product.
2. Always inspect the product for damage before and after use. If any abnormalities are detected, discontinue use immediately.
3. After use, clean or disinfect and store in a safe place.

9. Storage Method
– Store at room temperature

10. Packaging Unit
– Company’s standard packaging unit

11. Manufacturer
– Techcord Co., Ltd., 13, Gukje Science 2-ro, Yuseong-gu, Daejeon