Product Details
Size
3m Cord
Units Per Inner
-
Inners Per Carton
-
Carton quantity
100 pks
Sterile
Sterile
Use
Colour
-
More Information
Indications
Disposable Electrosurgical Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current.
Precautions and Warnings
General
- Completely inspect package and product prior to use.
- Do not use if the sterile packaging has been opened or damaged or if the electrode has any signs of damage on the insulation or the electrode cord.Prior to use, check the connection of all components of the pencil are correctly attached and check connection to the generator. Improper electrode installation may result in injury to the patient or operating room personnel.
- Follow all instructions in the electrosurgical generator’s manual. Refer to the generator’s manual of instructions for power setting recommendations for various electrosurgical electrode configurations.
- Confirm proper electrosurgical generator setting before proceeding with surgery. Use the lowest possible setting to achieve the desired surgical effect.
- The electrosurgical electrode should be in contact with tissue prior to turning on the power to the electrosurgical pencil. A complete understanding of the principals of monopolar electrosurgical procedures is necessary to avoid injury to the patient.
- The Mulitgate Electrosurgical Pencil is a monopolar electrode and requires the use of an electrosurgical return electrode plate to be placed under the patient before commencement of the procedure.
- The use of an abrasive cleaning pad is recommended for the removal of excess char during procedures.
Fire Hazard
- Electrosurgical instruments that are activated or hot from use can cause a fire. Do not place them near or in contact with flammable materials. Use a holster or quiver to hold electrosurgical pencils or similar accessories safely away from patients, personnel, and surgical drapes
Instructions for Use
- Prior to use, plug in the pencil’s cable into the corresponding jack on the electrosurgical generator.
- While the pencil is in use, maintain the load frequency of the electrode between 0.3 – 0.5MHz and the output power of the generator between 60 – 120W.
- When not using active electrode, place in a holster or quiver in a clean, dry, nonconductive and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in injury.
- The Multigate Electrosurgical Pencil should be used under the following conditions:
- Temperature: 5 – 40C
- Relative humidity: < 80%
- The maximum electrical capacity of the pencil is 5kVp
Storage
Store in a cool, dry place away from direct sunlight.
Shelf Life
Refer to the Expiry Date printed on each pack label.
Intellectual Property rights such as patents, patent applications, registered designs etc. apply to this product group.
For details refer to applications: 201514606, 421233, 201514608, 421234, 201613402.
Technical Note: "Single Use" Labelled Products
The symbol above is from ISO 15223. Its definition is “Do not re-use”.
As the standard document notes, this symbol is not intended to mean "single patient use" or "single procedure use”. Items labelled as “Single Use” should be placed in the appropriate waste container once the clinical use of the device has finished on the patient.
Single Use equipment is universally recognised as an effective strategy in the healthcare sector which minimises the risks of cross-infection.
Single Use devices don't have to withstand the rigours of reprocessing and allow the use of different materials and more complex designs. All manufacturers are required to have data to show that a Single Use device will function safely for that one use only. Modern devices are commonly fabricated from synthetic materials. The interaction of these devices with the human body often leaves a biofilm on all the surfaces of the device which may be impossible to decontaminate.
Multigate Medical Products does not supply reprocessing instructions for any of our products labelled as “Single Use”.
As with all sterile items, you need to check the integrity of the packaging before use. If the packaging is damaged in any way it can no longer be considered sterile. Items left over from an opened kit or procedure pack that are not used are considered as contaminated from an infection control perspective.
If you have any questions or would like more information on this topic, please contact your local Multigate Business Development Manager or our Customer Service Department.