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9983018EN

The document provides a technical data sheet for the 'LESSA' ECG electrode, which is a pre-gelled, disposable electrode designed for resting ECG, monitoring, and echocardiogram procedures. It features solid gel for good adhesion, is latex and PVC free, and complies with relevant standards and regulations. The electrode has a shelf life of 36 months and is packaged in units of 600, with various biocompatibility tests confirming its safety for use.

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11 views1 page

9983018EN

The document provides a technical data sheet for the 'LESSA' ECG electrode, which is a pre-gelled, disposable electrode designed for resting ECG, monitoring, and echocardiogram procedures. It features solid gel for good adhesion, is latex and PVC free, and complies with relevant standards and regulations. The electrode has a shelf life of 36 months and is packaged in units of 600, with various biocompatibility tests confirming its safety for use.

Uploaded by

Pegasus
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Avinguda Salvatella, 4

Polígono Industrial Can Salvatella.


Apdo. Correos 368
08210 – Barberà del Vallès –(BCN)
http://www.lessap.com | lessap@lessap.com
http://www.abmedicagroup.com; abmedicagroup@abmedicagroup.com
Telf.+34 93 7299400 | Fax +34 93 7191656

TECHNICAL DATA SHEET ECG ELECTRODE“LESSA”


99.830.18
Description:
Pre-gelled electrode with solid gel and Foam support.

General Features:
• Foam support protects the sensor and gel from cleaning and surgical products.

• Solid gel offers good adhesion even in skins that have not been adequately prepared and allows high quality
records with minimal adverse reactions.

The product features enhanced, non-sensitizing, acrylic copolymer coated foam. It provides a comfortable, soft
conformable electrode. This non-irritating, disposable electrode meets and exceeds all parametric tests as per
ANSI / AAMI EC12: 2000 Standard.

The product is designed to be used in a rest-type procedure. For example: Resting ECG / monitoring and echocardiogram procedures. It complies with
the RoHs regulations.

EXPECTED USE DIMENSIONS


Expected Use Resting ECG Electrode shape Oval
Monitoring
ECHO Procedures
Characteristics disposable, Electrode size (mm) 40x36
Latex free, PVC free, Area [mm²] 1162
not sterile
Product shel life 36 meses Area Gel [mm²] 201
Storage (min/max) +5° C/ +30° C Adhesive Area [mm²] 893

CLASSIFICATION AND REGULATION


CLASSIFICATION (MDD ART. 9) Class I
CLASSIFICATION (CFR 21 870.2360.) Class II

MATERIALS PACKAGING MATERIALS


Connector Staple Stainless steel Bag, interior layer Polyethylene (PE)
Label PET layer Bag, central layer Aluminium (Al)
Support Foam Bag, external layer Paper
Adhesive Medical grade Acrylic Boxes Cardboard
Sensor (Ag/AgCl)
Sponge -
Gel Adhesive solid gel
Release Liner Silicone PET layer (transparent)

PACKAGING Códe: 99.830.18 BIOCOMPATIBILITY Test - ISO 10993-1


Blíster 3
Units / pouch 30 Support (adhesive) Gel
Units / box 600 Cytotoxity passed passed
Batch and expiration date (it is indicated in each bag and box) Skin irritation test passed passed
Skin Sensititation Test passed passed

ELECTRICAL VALUES Units Typical Values AAMI limits


DC-Offset [mV]  1,5  100
DC Offset (5 seg after capacitatos discharge) [mV]  15  100
Recovery slope [mV/sec]  -0,3 1
AC-Impedance with 10 Hertz [Ω]  100  2000

ABGR7.2-01 Rev.01
Ficha técnica 9983654 eng

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