FIAB F7915 Reusable Grounding Plates For Electrosurgery Instruction Manual

: June 13, 2024
: FIAB

Table of Contents

FIAB F7915 Reusable Grounding Plates For Electrosurgery
Product Information
Product Usage Instructions
PREPARATIONS, CONNECTIONS AND USE
CONTRAINDICATIONS
Symbols
References
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FIAB F7915 Reusable Grounding Plates For Electrosurgery

FIAB-F7915-Reusable-Grounding-Plates-For-Electrosurgery-
product

Product Information

The product is a set of reusable grounding plates designed for use in electrosurgery. There are two models available:

Model F7915: Patient plates with a single conductive section.
Model F7930: Patient plates with a separate REM-type conductive section. The product is supplied non-sterile.

Product Usage Instructions

For REM Type

To use the plate with REM-type conductive section, follow these steps:

Connect the plate to an electrosurgical unit that has a system for checking the continuity of the high-frequency current return circuit.
Before starting the procedure, check that the alarm system is working.

Note: Always ensure proper connectivity and functionality of the electrosurgical unit before use.

During the Procedure

During the procedure, follow these guidelines:

Always select the lowest possible energy level.
If the coagulation capacity of the electrode is less than normal, do not increase the high-frequency output without performing the following controls:
- If the patient is re-positioned, check the contact of the plate with the patient’s skin and the cable connections.

Cleaning

To clean the grounding plates after use, follow these steps:

Wash the plates with running water immediately after the operation.
Plunge the plates in a solution of 2% normal disinfection product for approximately 45 minutes.

Note: Before reuse, visually inspect the plates for any visible damages. If there are any damages, replace the pad.

Storage

Store the product in its original package at the specified environmental conditions (temperature and relative humidity) mentioned on the pouch’s label. Avoid putting external heavy weights on the package to prevent damage.

General Notes

If a serious incident occurs during the use of the device or as a result of its use, report it to the manufacturer and your national authority. For any malfunction or defect of the device,
inform the Manufacturer’s Quality Service.

Waste Disposal

Dispose of any refuse derived from health structures according to the current regulations.

MODEL F7915 Patient plates with single conductive section.
MODEL F7930 Patient plates with separate REM-type conductive sections.
The product is supplied not sterile

WARNINGS

Check the packing for damages. Do not use the product in the case of damages or visible defects.
Select a well-vascularised area of skin close to the area to be operated: do not place the plate over scars or close to metallic prostheses or in the vicinity of ECG electrodes.
Shave, degrease, and dry the selected surface.
Make sure that the entire surface of the plate is in contact with the patient’s skin.
Connect the plate to the generator using the connector cable.
For connections and correct functioning, follow the instructions for use supplied by the manufacturer of the ESU unit and pencil being used.
High-frequency electrosurgical generators, pencils, and accessories to be used with the present product, should comply with the regulations in force.
The devices must be connected and put into operation only by qualified personnel. N.B. The current must never flow in a transversal direction across the body, not cross the chest.
Do not submit a patient with an implanted pacemaker to electrosurgical current without first consulting a cardiologist.
For the REM type: Check that the generator alarm system is working before starting the procedure.

PREPARATIONS, CONNECTIONS AND USE

Attach the neutral plate to the patient in a well-vascularised muscular area close to the area of operation, but distant at least 20 cm.
Spread with electro-conductive gel all the active conductive surface of the grounding pad.
Do not apply the plate over wounds or scars, close to metallic prostheses in the vicinity of ECG electrodes, or in areas of potential liquid flow.

N.B. Passage of the current within the patient’s body should be as brief as possible and should proceed diagonally. The current must never flow in a transversal direction across the body, nor cross the chest. The patient must be positioned on a dry and electrically insulated surface. The patient must be kept insulated from conductive parts, and the operation table must be suitably “grounded”. Use dry gauze to avoid areas of the skin coming in contact with each other. Connect the plate to the high-frequency generator using the connector cable. Then connect the pencil and, if any, pedal switch to the generator.
FOR REM TYPE
Connect the plate to an electrosurgical unit developed with a system for checking the continuity of the high-frequency current return circuit. Check that the alarm system is working before starting the procedure. During the procedure, always select the lowest possible energy level. If the coagulation capacity of the electrode is less than normal, do not increase the high- frequency output without previously carrying out the following controls:

the correct positioning of the grounding plate.
the correct connection of the cables and their connectors.
the correct activation of the starting keys (hand-switch of foot-control).
that there is no damage to the insulation of the cables.
that the electrode is not dirty. If the patient is “re-positioned” check the contact of the plate with the patient’s skin and the cable connections.

CLEANING
Wash with running water immediately after the operation, then plunge for around 45 minutes in a solution 2% of a normal disinfection product. The pads can be reused only if they are correctly used, therefore please make a visual check of the product before use. In case of visible damages replace the pad.
POSSIBLE CAUSES OF BURNS
Burns can be caused by a high current density in the patient’s tissue, or by the heating of fluids or inflammable gases; the causes can be the following

The plate is not well positioned or has been re-positioned.
The patient has been inadvertently positioned in contact with electrically conductive parts.
There has been a direct contact between the cables and the patient’s skin which has provoked a capacitive effect.
The combustion of inflammable disinfectant agents.
The combustion of inflammable narcotic gases.

CONTRAINDICATIONS

The product must not be used:
If there is visible damage to the plate or the connector cable.
If the contact between the plate and the skin is not good.
If the patient wears a pacemaker, unless there has been a prior cardiological consultation.

STORAGE
The product must be stored in the original package at the environmental conditions (temperature and relative humidity) specified on the pouch’s label. Putting external heavy weights on the package, the product could be damaged.

GENERAL NOTES
If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. For any malfunction or defect of the device, inform the Manufacturer’s Quality Service.

WASTE DISPOSAL
Refuses deriving from health structures must be disposed in according to the regulation in force.