Name: Disposable Electrosurgical Plate ( Grounding Pad )
Model: HC-NE1-1A
Monopole Grounding Pad for Adult
PRODUCT CHARACTERISTICS:
Product Name:HC-NE1-1A Monopole Grounding Pad for Adult
HC-NE1-1A: Monopole Grounding Pad for Adult
Packaging: Single packaging with aluminum plastic bag
Regulatory Requirement
This product complies with regulatory requirements of the European Directive 93/42/EEC concerning medical devices.
Classification:
MDD 93/42/EEC classification:
Class IIb according to Rule 9
Model of operation:
Continuous Operation
Degree of protection against electric shock:
Type BF Applied part
Electric shock protection grade:
The electric shock protection grade of the product depends on the connected high frequency electrosurgery (generator) apparatus. Please refer to the user manual of the designated high frequency apparatus.
1. Intended Purpose
This disposable Disposable neutral electrodes for adult and paediatric patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures, and provide a return path for the high frequency current with such a low current density in the body tissue that physical effects such as unwanted burns are avoided.
2. Product Introduction
2.1 Product Description
1)This Disposable neutral electrodes for adult and paediatric patients with conductive
adhesive gel is used as neutral reference during electrosurgical procedures, and provide a
return path for the high frequency current with such a low current density in the body tissue
that physical effects such as unwanted burns are avoided.
2)The applied product is designed for use with high frequency surgical generator
(Electrosurgical unit) only.
3)The disposable device is non-sterile product for single use, and consists of Aluminum
electrode, electrode carrier made by PE foam/self-adhesive gel, and cable. The Aluminum
electrode is applied part of Disposable neutral electrodes.
4)The connector or plug fits into electrosurgical unit, e.g. Manufacturer, BySC Electronics,
Model, Surgitom.
2.2 Specification
1)Cable length：3 ~ 5 m;
2)This electrode is biocompatible following requirements of ISO 10993 series.
3)Package material: Aluminum Foil bag.
4)Adhesion: Bear the weight of 200g,30S;
5)Electrical conductivity: Access high-frequency current of 1.3~1.5A, power loss≤10W;
6)Cytotoxicity: ≤1grade;
7)Sensitization: None;
8)Irritation of primary skin: Slight;
9)Conductive paste surface shall not be detectable the coliform group,pseudomonas
aeruginosa,staphylococcus aureus,streptococcus hemolyticus;
Total plate count of bacteria cfu/g≤100
Total plate count of fungi cfu/g≤100
2.3 Accessories
1) Rem-plug 2) Non Rem plug 3) 6.3Hi-Fi Plug 4) 5.3Hi-Fi plug
To make it function, please make sure this device is used in combination with designated high frequency electro surgery unit and an Electrosurgical Pencils.
CAUTION:
The use of apparatus that is incompatible with this device may lead to injury of the patient of damage of the device.
3.Operation Environment
Ambient temperature: 10-40degree
Relative humidity: 30-75%
Atmospheric pressure: 700-1060 hPa
The connector or plug fits into electrosurgical unit,
e.g. Manufacturer, BySC Electronics, Model, Surgitom.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
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