Electrosurgical Pencil

This product facilitates precise incision at the surgical site, rapid blood coagulation during procedures, and the removal of tissues or skin lesions. It is designed to be sterile and single-use, and it is compatible with all Electrosurgical devices available in the market.

Electrosurgical Pencils (ESU Pencil) are used for cutting and hemostasis. This product delivers a high-frequency electrical current through an active electrode, which results in tissue cutting or coagulation. Electrosurgical Pencils are used for cutting in surgeries related to the liver, spleen, thyroid, and open-heart surgeries, as well as laparoscopic procedures. One of the advantages of this product is its ability to achieve quick hemostasis, especially in vascular-rich areas. In comparison to mechanical surgical knives, this pencil offers more effective performance and is more applicable in certain surgical areas such as endoscopic regions. The product is sterile, disposable, and compatible with all available electrosurgical devices in the market.

Direction for use

This product should be used by trained personnel.
Connect the plug to the electrosurgical device and remove the protective cover of the electrode.
Check the buttons to see if they’re functioning properly.
Use the yellow button to cut and use the blue button to coagulate.
Turn off the Electrosurgical device after surgery and throw away the disposable pen.

Features

Single-use
Features both cutting and hemostasis function
Hand-controlled
Different colors on each button indicate their functions for easy operation
Lightweight and non-slip design for comfortable performance during surgery
Manufacturing Licensed by Iran National Medical Device Directorate
Sterilized with Ethylene Oxide
Lightweight and ergonomic design
High-quality materials
Double-layered sterile packaging
Compatible with most Electrosurgical devices
Complies with international standard ISO13485
CE marked by Eurofins Italy

Material

Plastic casing: ABS resin plastic
Activation switches (CUT & COAG): ABS resin plastic
Socket mold: ABS resin plastic
Connecting wire: copper with PVC coating
Banana plugs: Nickel-plated brass
Probe holder: Bronze
Blade electrode: 70mm
Blade: Stainless steel
Printed circuit board: fiber
Sterile pouch: Cellulose, medical grade. Film PET/Polyethylene

Main dimensional properties

Hand length with active electrode: 215 ± 2 mm
Banana plugs: 3 x Ø4.37 ± 0.05 mm
Wire length: 270 ± 10cm
Total electrode length: 70 ±1 mm
Exposed electrode length: 44 ±1 mm
Diameter of the electrode: 2.36 ± 0.02 mm
Electrode insert: hexagonal

Electrical properties

Electrical requirements according to IEC 60601-2-2 are met
Electrical requirements according to IEC 60601-1-2 are met
Electrical requirements according to IEC 60601-1 are met

Biocompatibility

ISO 10993-5: No cytotoxic
ISO 10993-10: No sensitizing, negative intracutaneous irritation test

Conclusion: This Product is biocompatible.

Sterilization and expiry date

Sterility: Ethylene oxide
Shelf life: 3 years
Cannot be used if the package is damaged or torn

Storage and maintenance

Keep protected from direct sunlight and the outside
Keep in a dry place
Relative humidity: 0% – 70%
Temperature limitation: -10ºC to 40ºC
Single-use product

Packaging

Cardboard boxes containing 100 units

Regulatory Information

D.G.Dena guarantees that this product is in conformity with Directive 93/42/EEC and that it has been manufactured following the directives of the Quality Assurance System certified as ISO 13485. This product is classified as:

Class IIb sterile product according to Annex IX of Directive 93/42/EEC, rule 9.
GMDN code: 61869. Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
UMDNS code: 11499. Electrodes, Electrosurgical, Active, Hand Controlled.

Contact Us

D.G.Dena

D.G.Dena is a well-established and professionally managed company with more than 20 years of distinguished record in research and development, production, and marketing of medical equipment in domestic and overseas markets.