Device Description; Intended Use; Contraindication; Side Effects And Residual Risks - Delmont imaging flexible bipolar electrodes Instrucciones Para El Uso

Instructions for use: flexible bipolar electrodes
This manual is for references: D300 140 010, D300 140 011 and D300 140 038.

1. Device description

HF-flexible bipolar electrodes are connected to proper HF-cable to perform endoscopic procedures using a 0.9%
NaCl solution.
Carefully read these instructions before using Delmont imaging HF-flexible bipolar electrode. Keep
them in a safe place for future reference.
1.1.

Intended use

These products are intended for ablation, cutting, vaporization and coagulation of tissue in the following surgical
fields: «Urology – Resectoscopy» and «Gynecology – Hysteroscopy».
The products must be used only in medical facilities by trained and skilled medical personnel. The products must
not be used if according to a qualified physician, the general condition of the patient is not adequate or if the
endoscopic methods are contraindicated.
1.2.

Contraindication

Do not use the devices if one or more below reported condition is present:
- acute inflammation of the abdominal area,
- infection of the vagina,
- existing pregnancy,
- patient with pacemaker,
- presence of flammable or explosive substance,
- the device has been already used to treat patients with suspected or verified BSE, CJK / vCJK diseases.
Surgical patients identified as at-risk for Creutzfeldt-Jakob disease (CJD) and related infections
should be treated with single-use instruments. Therefore, devices that have been in use or suspected of
use on a patient with CJD after surgery must be disposed according to current national recommendations.
Improper use can lead to hazardous situations.
1.3.

Side effects and residual risks

- When direct or low-frequency current enters the body, electrolysis occurs at the electrode-tissue inter-
face. The chemical effects of electrolysis disappear at higher frequencies.
- Direct or low frequency current can depolarize cell membranes and cause neuromuscular excitation.
- Electrosection results in more collateral tissue damage compared to scalpel surgery, creating some
histologic distortion of surgical margins.
-Thermal damage may cause carbonization at the excision margin, vessel thrombosis, and collagen de-
naturation. Therefore careful evaluation of the advantages and suitability of the intended application is recom-
mended.
D900 700 027 B Rev 07/2018
delmont
imaging
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