1.   Product name

Disposable Neutral Electrode

2.   Specifications

This product is divided into unipolar and bipolar. The models and specifications are shown in the following table.：

3.   Performance

1. Risk of thermal damage: The product should not expose the patient to the risk of thermal damage when applied under normal conditions of use.

2. Contact resistance: The contact impedance should not exceed 50 Ω in the frequency range of 200 kHz to 5 MHz.

3. Adhesion: Apply 10N force to the connected cable for 10 minutes, and the product adhesive area should not be more than 5% away from the skin surface.

4. Flexibility: During the 1 hour period, no more than 10% of the adhesive area should be removed from the skin surface.

5. Liquid tolerance: Within 15 minutes after splashing saline, no more than 10% of the adhesive area should be separated from the skin surface.

6. Microbial indicators: The total number of bacterial colonies should be ≤100cfu/g, and the total number of fungal colonies should be ≤100cfu/g. Coliform, Staphylococcus aureus, Pseudomonas aeruginosa and hemolytic streptococcus should not be detected.

4.   Scope of application

Used in conjunction with high-frequency surgical equipment, it is connected to the patient's body to provide a low current density return channel for high frequency currents.

5.   Composition

The disposable neutral electrode consists of foam, aluminum foil, conductive gel, and release paper.。

6.   Instructions

1. This electrode should be placed in a patient's thick, well-blooded area (such as the thigh, buttocks or upper buttocks). It should not be placed in the protruding parts of the bone, joints, hairy or scars, or under the patient's body.

2. The patient's skin should be cleaned before placing the electrode and the hair should be removed if necessary.

3. Pull off the electrode release paper, stick the electrode to the appropriate part of the patient, and clamp the aluminum foil on the protruding end of the electrode with the lead clamp. Note that the two metal pieces in the clip should be in contact with the aluminum foil, and the aluminum foil should not be exposed.

4. After the operation is finished, slowly pull off the electrode to avoid damage to the skin.

7． Contraindications

1) Do not use with endoscopic surgical equipment (through the same tunnel into the patient);

2) Patients with allergies should be used with caution.

8.   Cautions

1) When using an electric knife and monitoring at the same time, please strictly follow the operating instructions of the electrosurgical unit, otherwise it may cause high frequency burns on the electrode parts.

2) This product is used with unipolar and a high frequency electrosurgical unit with a neutral electrode continuity monitor. The bipolar of this product is used with high frequency electrosurgical equipment with contact quality detectors.

3) The rated voltage of the neutral electrode is 1600V, and the maximum output voltage of the high frequency operation mode should not be greater than the rated voltage.

4) Check the application of the neutral electrode and its connector when there is a drop in output or interruption in the correct operation of the HF surgical equipment.

5) When using, keep the skin dry at the pasting place.

6) Do not use neutral electrodes on nipples, skin wrinkles, bone nodules, scar tissue or damaged skin.

7) People with skin allergies should be used with caution.

8) Do not open the package unless it is used immediately; after the package is opened, it should be stored and the relative humidity is not more than 80%.

Ambient temperature range: -5 °C ~ +40 °C, well ventilated room.

9) This product is for one-time use and should not be reused.

10) Dispose of the product in accordance with the Regulations on the Administration of Medical Waste (State Council Order No. 380).

11) For the selection of a monitorable neutral electrode, a device with a high frequency contact quality monitor must be provided and cannot be connected to ordinary high frequency surgical equipment.

12) Instructions for using a monitorable neutral electrode

The monitorable neutral electrode should be used with a high frequency surgical device with a contact quality control monitor.

13) Description of compatibility with dedicated monitorable neutral electrodes

WARNING: If a compatible neutral electrode is not used, when there is no safe contact between the neutral electrode and the patient,

The contact quality monitor does not produce an audible alarm.

Description: It is about the requirements of contact quality monitors in high frequency surgical equipment.

9． Storage and transportation conditions

It should be stored in a room with a relative humidity of not more than 80%, an ambient temperature range of -5 °C to +40 °C, and good ventilation.

10．Shelf life

Under the conditions of the storage rules, the product is valid for 24 months from the date of production.

Production date / expiration date on label.

11．Explanation of graphics and symbols

12．Date of preparation of the manual

May 2017

Registrant / Production Enterprise / After-sales Service Unit：

Suzhou LetaiMedical Technology Co.,Ltd

Address：B7, No116 Wutaishan Road, SND, Suzhou

No. 22, Xiexin Road, Suzhou High-tech Zone,Suzhou

Tel/Fax：86 512-68784262   

Postcode：215163