progetti DFBPED01PRC Disposable Multifunction Electrodes Instruction Manual
- September 27, 2024
- Progetti
Table of Contents
progetti DFBPED01PRC Disposable Multifunction Electrodes Instruction
Manual
DFBAD01STD / DFBAD01PRC / RS4-DFB01PRC / RS4-DFBAD01PRC / RS4-DFBPED01PRC
DFBPED01PRC
DISPOSABLE MULTIFUNCTION ELECTRODES
Before use, please read all safety instructions contained in this manual carefully.
Each sealed pouch contains a pair of gel electrode pads that can be used instead of reusable manual pads, with direct connection to therapy cables and defibrillators. They allow the operator to intervene effectively in the treatment of arrhythmias associated with the applications listed below, without the risk of accidental electric shock.
APPLICATION
PROGETTI disposable multifunctional electrodes are suitable for: External transthoracic defibrillation,
- Synchronized transthoracic cardioversion,
- Transthoracic ECG monitoring,
- Transthoracic (non-invasive) temporary electrical stimulation of the heart.
The product is intended for use in a non-sterile environment by qualified
medical personnel and/or, where appropriate, by persons trained in
cardiopulmonary resuscitation (CPR) and the use of an automated external
defibrillator (AED).
The adult models are intended for patients weighing over 25kg.
Pediatric models are intended for children weighing less than 25 kg.
CONTRAINDICATIONS
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The use of PROGETTI disposable adult electrodes is generally prohibited in patients under 8 years of age (with a weight of less than 25 kg). However, they can be used if the chest allows it, Care must be taken to ensure that the electrodes do not touch each other and that the defibrillator operating instructions for the Energy is taken into account.
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The use of PROGETTI disposable electrodes in the adult version is prohibited for children under 12 months (weighing
of less than 10 kg). -
The use of the PROGETTI pediatric multifunctional disposable electrodes is generally for patients over 8 years of age (weight over 25kg) is not suitable.
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Do not apply to irritated or injured skin.
INSTRUCTIONS FOR USE External
defibrillation and synchronized cardioversion: PROGETTI single-use
multifunction electrodes are capable of transmitting the electrical energy
delivered by the defibrillator to the patient up to a maximum of 360 J for the
adult or adult/pediatric version and 100 J for the pediatric version; they can
withstand up to 50 defibrillation discharges.
The depolarization of the critical mass of the myocardium, which is essential
for the success of the treatment, is only possible if it is crossed by a
current of appropriate intensity: the active surface of the electrodes is
optimized for this purpose.
It is therefore advisable not only to select the application sites carefully, but also to apply the adhesive pads in such a way that their contact surface with the skin is as large as possible. The amount of energy to be delivered is determined by the user at his own discretion.
In pediatric applications, resuscitation guidelines recommend administration of 2-4J/kg of energy; the recommended initial dose is 2J/kg and 100J should not be exceeded to avoid burns.
CAUTION Do not deliver the shock using manual metal pads over the disposable
electrodes or the ECG electrodes.
Non-invasive transthoracic stimulation: PROGETTI multifunctional disposable
electrodes can be used for non-invasive transthoracic stimulation. To minimize
the stimulation threshold, the adhesive pads should be applied in the manner
described above. In addition, a good knowledge of the equipment to be used is
necessary. The instructions provided by the manufacturer must be followed
precisely.
WARNING It is recommended to replace PROGETTI multifunctional disposable electrodes after 8 hours and, in case of prolonged electrical stimulation (over 30 minutes), to check that the patient’s skin does not show any signs of irritation.
WARNING PROGETTI multifunction disposable electrodes should be replaced after 30 minutes if the pulses delivered are monophasic and last longer than 20 ms.
ECG monitoring: The PROGETTI multifunctional disposable electrodes can also be used for ECG monitoring.
CAUTION If the ECG signals are not clear enough, a separate set of ECG electrodes should be used where an ECG patient cable is available.
INSTRUCTIONS FOR USE
- If electrodes are pre-connected, leave the plug in the socket of the defibrillator according to the instructions of the defibrillator. defibrillator.
- Expose the chest and prepare the skin. Remove excessive body hair 0. Lightly roughen the skin surface, to reduce contact impedance. Do not place the adhesive pad on the nipple or breast tissue.
- Remove any residues (dirt, grease and abrasion) using non-flammable cleaning agents. Make sure that the application sites are dry and clean.
- Open the package and take out the multifunction electrodes.
- Carefully remove the protective cover starting at the tab to expose the adhesive and conductive zones.
- The locations where the adhesive pads are to be applied are indicated in the “POSITIONING AND POLARITY” section.
- Apply the adhesive pads one by one, starting on one side and gradually spreading them over the entire surface to prevent the formation of air bubbles and to ensure complete adhesion to the skin. The adhesive pads well separate from each other and make sure that they do not lie on other objects (ECG electrodes, cables, transdermal patches, clothing, etc.).
- Do not reposition the adhesive pads after installation. If their position needs to be changed, and replace with a new multifunctional electrode. Repositioning will result in reduced adhesion and an increased risk of burns.
- Insert the electrode plug into the defibrillator socket or the defibrillator port according to the defibrillator operating instructions. Patient cable (if not already connected in case of pre-pluggable electrodes).
- For demand stimulation, connect the ECG monitoring electrodes separately.
- To avoid irritating the patient’s skin, remove the adhesive pads after treatment by gently peel from one edge.
- Unplug the defibrillator and dispose of the electrodes together with their packaging.
POSITIONING AND POLARITY
The international guidelines indicate several positionings that are equally
valid for the treatment of atrial or ventricular arrhythmias.
The following figures show the application sites commonly used and recommended
by most defibrillator manufacturers. Select the application sites most
suitable for therapy in accordance with the instructions of the manufacturer
of the defibrillator to be used.
For ease of application and training purposes, the anterolateral positioning
(Fig. 1) is preferred for defibrillation and cardioversion of arrhythmias; the
anterolateral positioning (Fig. 2) is more widely used for hemodynamics and
transthoracic pacing and is recommended in case of application of adult
electrodes over pediatric patients.
To maintain the correct polarity of the signal, place the electrodes in the indicated positions (the apical electrode is indicated by the heart symbol). Please note that it is not relevant for the treatment which electrode (apical/sternal) is placed in either position.
SIDE EFFECTS
Adhesives on the electrodes may cause skin irritation
- Prolonged transthoracic stimulation or repeated delivery of defibrillatory shock may result in more or less visible redness of the skin.
- Poor adhesion to the skin or air bubbles under the electrode can lead to skin burns
PRECAUTIONS AND NOTES
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Only use the product with compatible defibrillators. Check compatibility using the information on the packaging.
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Read the defibrillator instructions for use, paying particular attention to the positioning of the
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Multifunctional electrodes, their polarity and the amount of energy delivered.
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In pediatrics and in some models of automatic defibrillators, the use of specific
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Energy reduction devices or the application of special precautions may be necessary. Always pay close attention to the energy levels indicated on the defibrillator and applicable to pediatric patients (see section “INSTRUCTIONS FOR USE”).
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The choice of electrodes should be based on the assessment of the patient’s breast size and weight.
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Pediatric electrodes used beyond the specified power limit may also cause major skin burns; on the contrary, the active surface of adult electrodes could render the therapy ineffective if used for pediatric treatment.
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After a long period of transthoracic stimulation, the ability to detect the evoked ECG signal may be reduced. In this case, the evoked signal must be recorded using a separate set of ECG electrodes.
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Replace the multifunctional disposable electrodes after 24 hours of application to patient skin.
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Do not use the electrodes if they have passed the expiration date printed on the packaging.
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The traceability and expiry date of the product are indicated only on the packaging: keep the packaging or write down REF and LOT # for a possible reference to the electrodes used.
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Check the integrity of the packaging: otherwise do not use the product.
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Do not open the packaging of the multifunctional electrodes until you are ready to use them. The adhesive pads should be removed immediately after be applied to the patient’s skin after the protective layer has been removed.
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Do not use the multifunction electrodes if the gel has come away from the base, or if it looks torn, separated or dry.
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Any local color changes in the gel or in the conductor foil do not affect the functionality of the product.
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Do not use the multifunction electrodes if the product has been damaged when removing the protective cover (e.g. the insulating protection of the contact has come loose or cracks have formed in the foam pad and/or the electrode).
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Do not bend, cut or squeeze the adhesive pads.
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Do not use the multifunction electrodes if the connector or cable is damaged.
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Check the defibrillator’s instructions for use to determine the safety distances at which devices must be positioned, that emit strong electromagnetic interference (electroscalpels, RF ablators, diathermy devices, mobile phones, etc.).
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Position the defibrillator electrode system at a distance of at least one and a half times the recommended distances.
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The electrodes and their cable contain ferromagnetic materials and must therefore not be used in the presence of the strong magnetic field a magnetic resonance imaging (MRI) scanner.
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To avoid accidents caused by electric shock, users must not touch the electrodes, with the patient or with conductive parts near the patient.
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When the defibrillators are used near sources of oxygen or other flammable gases, they must be
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Extreme care must be taken to avoid fire or explosion.
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The product is not sterile. It must not be disinfected or sterilized.
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The product is intended for single use only – do not reuse. Reuse may result in the materials change and the original functional properties of the product are lost.
POTENTIAL COMPLICATIONS
No complications are expected that can be attributed to the use of the multifunctional electrodes.
CAUTION: The electric shock from the defibrillator can cause irregularities in the operation of an implanted pacemaker/defibrillator; place the multifunction electrodes at least 8cm apart. After a shock from the defibrillator, check that it is working properly.
CAUTION: If the energy level selected is insufficient, the success of the
treatment could be jeopardized.
Conversely, larger amounts of energy than necessary could alter the enzyme
structure without evidence of actual myocardial damage.
PRODUCT LIFE AND STORAGE
See the expiry date indicated on the packaging.
The product must be stored in its original packaging, in premises that comply with the environmental, temperature and humidity conditions indicated on the packaging label. The packaged electrodes can be exposed to extreme temperatures from -30°C to +65°C for up to 7 days. Prolonged and/or repeated storage at extreme temperatures will shorten the remaining life of the product.
CAUTION: Placing weights on the packages may damage the product.
DISPOSAL Waste from health structures must be disposed of in accordance with
current regulations.
GENERAL INFORMATION
If a serious incident occurs during or as a result of the use of this medical device, report it to the manufacturer and your competent national authority. In the event of a malfunction or defect in the device, inform the manufacturer’s quality service department.
page 6
PROGETTI S.r.l.
Strada del Rondello, 5 – 10028 Trofarello (Torino) – Italy
info@progettimedical.com – www.progettimedical.com
References
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