FIAB 141667 ECG Electrodes Instruction Manual

: June 3, 2024
: FIAB

Table of Contents

DESCRIPTION AND SPECIFICATIONS
DIRECTIONS FOR USE
STORAGE
WARRANTY AND LIMITATIONS
References
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ECG ELECTRODES
INSTRUCTIONS FOR USE

DESCRIPTION AND SPECIFICATIONS

FIAB Disposable electrodes for ECG have been designed for the surface recording of cardiac activity through the use of any kind of electrocardiographic monitoring device.
The products must be used by qualified healthcare personnel.
The description of each different model is specified on the electrode’s pouch.
FIAB electrodes can be classified on the basis of the following technical features:

Connection to the patient cable: clip, plug, tab.
Shape and dimensions: some models are available also in paediatric and neonatal versions. See on the label.
Gel status: solid, liquid.
Pad’s material: waterproof FOAM, transpiring nonwoven material.
Magnetic resonance compatibility: some models are available also in radiotransparent version and are suitable for magnetic resonance.
For a general description of technical features please look on the pouch of each model.
Adhesiveness is guaranteed by a biocompatible medical grade adhesive.
The electrodes comply with the requirements of ANSI AAMI EC12 standard.

DIRECTIONS FOR USE

Check that the package, the electrodes and the gel are intact; in case of any damage do not use the product.
Select an area free of hair, cutaneous lesions or scars, folds of skin or bony protuberances.
Shave (if necessary), clean and dry the application surface.
Avoid the use of solvents; these can result in skin irritation and reduce electrode adhesion.
If alcohol is used, make sure that this has evaporated or been completely removed before the application of the electrodes.
If necessary, friction the skin gently to improve the adherence of the product.
Connect the electrode to the patient cable before positioning it on the skin, in order to avoid the gel escaping from the sensor.
Remove the protective support and immediately dispose off in the assigned waste bin for disposal. Then apply the electrode to the skin surface.
When the recording is complete, disconnect the electrode and remove it gently from the skin, avoiding cutaneous irritation.
Throw away the product after use (see “Waste and disposal”).
Close the bag carefully so that the remaining electrodes do not dry out.

WARNINGS

Remove the electrode gently from the skin to avoid skin irritation.
The electrodes must be replaced if they do not properly attach to the skin.
Do not use the product if alterations in the gel are noted.
The product is supplied not sterile.
This is a single-use product, do not re-use it. Reusing the product may lead to: alteration of materials; loss of initial functional features of product.
The equipment and the connecting leads used with this device must comply with the regulations in force.
For correct use of cables and equipment, follow the manufacturer’s instructions.
Do not use the product on patients with previous episodes of cutaneous irritation or contact allergies.
The electrodes are in accordance with the biocompatibility ISO10993-1.
Electrodes must be placed and connected by qualified staff.
Protective support should be immediately disposed off in the assigned waste bin for disposal after removal of electrodes.
Do not apply the electrodes to skin with abrasions, erythema or wounds.
Once applied, do not change the position of electrodes.
During electro-surgical procedures do not place the electrodes close to the neutral plates or to the operating field.
As a general precept, replacement of the electrodes is recommended after 48 hours and mandatory after 72 hours.

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.

WARRANTY AND LIMITATIONS

Compliant with current European legislation on Medical Devices. Manufactured according to the procedures of the ISO 13485 certified Quality System. No responsibility
can be attributed to the Manufacturer, who will not be obliged to compensate medical expenses or direct or indirect damages, deriving from the non- functioning or anomalies
of the above devices, if they are used differently than as foreseen in these instructions for use. It is recommended to promptly inform the Manufacturer’s Quality Assurance
Service for any malfunction or defect that was discovered regarding this device. Any serious incidents relating to the device must be reported to the Manufacturer and to the
competent authority of the Member State where the user and / or patient is located.
WASTE DISPOSAL
Waste coming from hospitals must be disposed of accordingly with regulations in force.
Rx ONLY – CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

| Compliant with current European legislation on Medical Devices
---|---
MD| Medical Device
UDI| Unique Device Identifier
| Caution, consult accompanying documents
| Consult instructions for use
| Manufacturer
REF| Catalogue number
LOT| Batch code
| Date of manufacture
| Use by
| Do not reuse
| Non-sterile
| Temperature limitation
| Humidity limitation
| Keep away from sunlight
| Quantity of pieces
| Do not contain natural rubber latex
| Do not contain PVC
| Not compatible with MRI procedures
| Adult
| Paediatric
| Neonatal
| Radiotransparent