Protect and Save Lives

Date：3/9/2021

Reusable Electrosurgical Pencil

 

 

Product Name: Reusable Electrosurgical Pencil

 

 

Model: See Product Label

 

Compatibility: See Product Label

Application: High Frequency surgical equipment

Specifications:

Temperature Limitation: - 10^oC to + 40^oC

Operating Humidity: 0-80% non-condensing

Storage/Transportation Humidity: 0-80% non-condensing

Hyberbaric Pressure (Storage/Transportation): 86kPa-106kPa

Output electric current at most 1A;

Frequency of appliance: 0-1.0MHZ;

Impedance of loading: 200Ω

 

 

Brief Introduction:

 

 

These products are consisting of the connector, cable, manual handle and electrode.

 

 

 

Intended Use:

 

 

The reusable Electrosurgical Pencil is intended for use in general surgical procedures to deliver electrosurgical energy to the surgical site for tissue cutting and coagulation. The device may be used with electrosurgical generators which accept a standard three-pin plug.

 

 

 

Instructions for Use

 

 

Please refer to the high frequency surgical equipment user documentation for detailed information.

 

Taboo:

1)     Generally speaking, patients taking heart pacemaker, cardiac pacemaker, heart pulsator, heart starter can not use high frequency electrotome, because high frequency may interfere heart pacemaker, cardiac pacemaker, heart pulsator, heart starter working normally or even causing halt. If it should be, we must take necessary and effective defendant methods according to the instruction.

 

 

2)     When patients take metal implant (steel hoop, steel nail and so on) in their bodies, try to keep the channel of high frequency electric current away from it. This also prevent high frequency backset from scalding cells of patients during the process of heating up.

 

 

 

 

 

 

Attentions:

 

 

a)     Output must be suspended completely, that is, the high frequency pressure output of high frequency electrotome must be isolated from casing and electrical source strictly.

 

b)     The metal crust of high frequency electrotome instruments should be grounding safely.

c)     Bits of useless do not access to the instrument, if it has done, put them into insulative containers instead of anywhere.

d)     High frequency electrotome should be operated by doctors and nurses who have been trained and confirmed. For the safety, they should also read the instructions carefully before use it.

e)     No gas; liquid or other easy to be burned and exploded things. Do not use anesthetic and disinfector which are easy to be burned and exploded. Get rid of the burnable gas and liquid existing in the holes of body (such as rectum; urinary bladder; vagina etc.)

f)      Plate should be arranged next to the operational area.

g)     The output power should guarantee the operation effect, do not increase the power blindly, because any dangers in the operation may be increased with the power increase.

h)     Outside system of electrotome made of plate; bit; connecting cable and patient cannot contact with ground metal or metal with heavy capacitance, or the bit may be changed from suspension to the grounding connection. During the operation, the patients should not take or touch non-grounding conductor which may cause serious high frequency radiation by concentrating high frequency electromagnetic field. Doctors and nurses should wear rubber gloves to avoid burnings by forming grounding points.

i)      In order not to be interfered, custody electrodes and measuring probe should be far away from the operation area, especially the channel of operation electric current (from bit to plate). To avoid multipoint earthing, try to use metal electrode, especially needle-like and little-area electrode.

j)      Do not use over-length electrode and cable, which may increase high frequency leakage of electricity, cause burnings, or increase the distance between electric knife and operating table. Staffs who stand there are likely to touch and kick the high frequency cable, thereby bring cable damage; plate moving, drop or even laceration.

k)     During the test or operation, do not touch the electrotome plate or bit with your uncovered fingers. Because of the high frequency radiation in the bit and plate, it may cause stimulations and burnings, though the high frequency leakage of electricity is below the safety standard.

l)      For electrode; cable; plate are easy to be damaged, please check their performance at any time.

m)    Plate should be arranged next to operational area.

n)     To guarantee the performance, plate should be arranged for an area which is clean; dry; muscular (not fat) and without out-skeleton (shave fur if necessary)

 

 

Warnings

 

 

1)     Do not connect the useless bit with the instrument. Put the bit not being used into insulative containers. To avoid burning patients and doctors when bit is operated mistakenly, do not lay the bit aside the patients.

 

2)     Like other electrical instruments, cable should be put away lest twine or stifle the patients.

3)     Monopole high frequency electrotome can not be used in dactylic or pedicel-like cells (such as children’s penis), because it may be damaged when passing heavy electric current.

4)     Doctors should wear classes with non-metal frame when having an endoscope electrotome operation to avoid burning doctors’ faces resulting from backset sent out by high frequency radiation.

5)     For its performance and safety, please do not change and modify the products.

6)     Do not use ray to disinfect.

 

 

Cleaning and disinfection by machine

 

 

If highly alkaline cleaners are use. Metal surfaces may be discolored. However, this does not affect the integrity of the product.

 

 

 

1.     Roll up the product loosely and lay it in the suitable rinsing basket. In doing so make sure the product is not touching other instruments or parts of instrument.

 

 

2.     Start a tested program with the following properties:

 

--- Thermal disinfection (10 minutes at 93^oC).

--- Final rinse with distilled or deionized water.

--- Sufficient product drying.

Check

1.     Check the product for visible damage and wear:

--- Damage to the product, e.g. cracks, rough surface, splintering.

--- Damage to the product insulation and / or cable / connector insulation, e.g. cracks and breaks. If damaged, do not use these products!

Packaging

1.     Pack the product in sterilization packaging (single or double packaging) made from paper / polyethylene and / or in a sterilization container.

 

 

Sterilization

 

 

Only sterilize products that have been cleaned and disinfected.

 

Please follow the recommendations issued by the sterilizer manufacturer concerning loading, handling, and drying times.

TRISEL recommends steam sterilization by any of the methods described below. TRISEL accepts no responsibility if different sterilization methods are used.

Steam

Fractionated vacuum method: holding time 5 to 20 minutes at 134 to 138^oC.

Fractionated vacuum method: holding time 20 minutes at 121^oC.

Note: *All registered trademark and brand style mentioned in this information is always belonging to the original made processor.