Disposable ESU Pencil

Hand Control Disposable Electrosurgical Pencil

FAQ:

1. What is cautery pencil?
A cautery pen is an essential tool for your medical and surgical teams. Surgical cauterypens–also known as cautery pencils or simply as cauteries–are handheld medical devices used to stop bleeding via heat conducted through the tip.

2. What is the pencil used for?
An instrument used for electrosurgical dissection and hemostasis. Frequently used as a synonym for electrocautery .

INTENDED USE 

The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical with a specified ESU generator. 

INDICATION 

The applied products are indicated for use in tissue cutting and coagulating as required or encountered in General surgery, thoracic surgery, gynecology surgery where the tip of the product can be accessable easily. 

CONTRAINDICATIONS 

The applied products are contraindicated where patients with cardiac pacemakers or other active implants, a possible hazard exists because interference with the action of the pacemaker may occur, or the pacemaker may be damaged.

PRECAUTIONS 

1. Examine pencil and electrode for defects prior to use.

2. Apparent low output or failure of the HF surgical equipment to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections. In this case, the application of the neutral electrode and its connections should be checked before selecting a higher output power.

3.When more than one active electrode is plugged into same generator, be aware activation of one pencil may take the receptacle of all the other pencils " live". Read and understand the warnings and cautions given by the electrosurgical generator manufacturer.

4. Do not prep the operative site with flammable solution such as alcohol.

5. This device is for single patient use only. It is not intended for disinfection and subsequent reuse, which may result in device failure and/or create the risk of contamination.

6. This device has not been evaluated for reprocessing or re-sterilization. Reprocessing and/or re-sterilization may damage the device, rendering it unusable and/or may lead to device failure, which could result inpatient illness, injury or death.

INSTRUCTIONS FOR USE

1.The Hua Cheng Disposable Electrosurgical Pencil is designed for use with electrosurgical generators equipped with the standard three(3)prong receptacle. Prior to use, read the manufacturer instructions on how to operate the electrosurgical unit and accessories.

2.Visually examine the package for damage before opening the package. Replace the pencil if the package or the pencil itself shows signs of damage.

3.Check the production and expiry date printed on the package. If the device using date exceed the expire date, it should be replaced by backup device within expire date.

4. Open the package using aseptic technique.

5. Uncoil the cable. Examine the pencil and cable for damage. Replace the pencil if damage found.

6.Remove and discard the electrode tip guard. Ensure that the electrode is securely seated in the pencil.

7.Plug the cable connector firmly into the correct receptacle on the electrosurgical generator. 

8.Verify that the "cut" control on the pencil works when the "cut" button (yellow) or switch is pressed. Repeat the same for "coag" control (blue button or switch).

9. Discard the pencil after use as a biohazard . Do not resterilize or reuse.

WARNINGS 

1.Electrosurgery is dangerous. Careless use of any part or element in the electrosurgical system may result in serious patient burns. Read and understand all warnings, cautions, precautions and directions for use before attempt is made to operate any active electrode.

2.The qualified operator of the device should be a physician or medical workers under the supervision of the physician.

3.Before use,the entire area of the neutral electrode should be reliably attached to a suitably prepared and appropriate area of the patient's body as defined by the manufacturer.

4.Keep active accessories away from patient when not in use,never lay the pencil on the patient or the patient drape. Use a safety holster or place the pencil on the instrument tray when not in use.

5.Keep active accessories away from flammable objects, gases or vapors at all times when in use.

6. Keep desired voltage/power as low as possible to achieve the desired end effect in order to minimize the potential for capacitive coupling and inadvertent burning at high voltages.

7. The cable be positioned in such a way that contact with the patient or other cable is avoided. Temporarily unused active electrodes should be stored in a location that is isolated from the patient.

8. Accidental activation or use the equipment when the power supply exceeds the rated voltage, the patient, operator, or his assistant may get hurt, and the electrode may be damaged.

9. The patient should not come into contact with metal parts which are earthed or 

which have an appreciable capacitance to earth (for example operating table 

supports, etc.).

10. Skin-to-skin contact (for example between the arms and body of the patient) 

should be avoided, for example by insertion of dry gauze. 

11. When HF surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed

as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended. In all cases, monitoring systems incorporating high frequency current limiting devices are recommended.

12. For surgical procedures where the HF current could flow through parts of the body having a relatively small cross sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.

13. The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N

2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away.

OPERATION ENVIRONMENT 

Ambient temperature: 10-40 degree

Relative humidity: 30-75%

Atmospheric pressure: 700-1060 hPa

STORAGE CONDITIONS 

Temperature requirement in warehouse: -20 ~ 60degree.

Humidity requirement in warehouse: 10 ~90 %RH.

Atmospheric pressure requirement in warehouse: 500-1060 hPa

DISPOSAL OF WASTE

The used disposable products should be destroyed and treated according to relevant local / national regulatory requirements. Randomly discard is strictly forbidden.

SHELF LIFE

The shelf-life of this disposable electrosurgical pencil can be guaranteed as 3 years.

Jinhua Huacheng Medical Appliance Co.,Ltd.

Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode

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