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APPENDIX D – INSTRUCTION FOR USE FOR DISPOSABLE MULTIFUNCTION
ELECTRODES FOR DEFIBRILLATOR
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.
IMPORTANT
The product is intended for use in non-sterile environment by authorized personnel only. Before using
the product, the user should deeply understand these instructions.
DESCRIPTION
The disposable multifunction electrodes PROGETTI are constituted by a pair of adhesive pads provided with
gels and direct connection to cables and defibrillators which may be used in place of the manuals reusable
paddles [1].
PACKAGING
Each pair of PROGETTI disposable multifunction electrodes is packaged in sealed envelopes of opaque
material suitable to protect the gel from light and moisture. Envelopes are included in the carton sales
package along with a copy of the operating instructions.
INDICATIONS
The disposable multifunction electrodes PROGETTI are indicated for:
• Transthoracic external defibrillation.
• Transthoracic synchronized cardioversion.
• Transthoracic ECG Monitoring.
• Temporary transthoracic cardiac pacing (non-invasive).
PROGETTI disposable multifunction electrodes allow the user to effectively operate in the treatment of
rhythm disorders related to the above-mentioned applications, without the risk of accidental electrocution
related to the use of normally available reusable paddles.
CONTRAINDICATIONS
• PROGETTI disposable multifunction electrodes for adults are generally contraindicated in patients
younger than 8 years old (weighing less than 25kg), but can be used if the size of the chest allow it, taking
care that one pad do not come in contact with the other one. Follow the operating instructions of the
defibrillator for energy to be delivered.
• The use of PROGETTI disposable multifunction electrodes in versions for adult or adult/paediatric is
generally contraindicated in patients aged less than 12 months (weighing less than 10kg).
• The use of PROGETTI pediatric disposable multifunction electrodes is generally contraindicated in
patients older than 8 years old (weighing more than 25kgErrore. L'origine riferimento non è stata
trovata.);
• Do not apply on skin that shows signs of irritation or injury.
MODE OF USE
External Defibrillation and synchronized cardioversion: the disposable multifunction electrodes are able to
transfer to the patient the electrical energy supplied by the defibrillator up to a maximum value of 360J in
the adult version and of 100J in the paediatric versionErrore. L'origine riferimento non è stata trovata..
The depolarization of the critical mass of the myocardium, which is essential for the success of the therapy,
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 appropriate, in addition to a targeted selection of the positioning
sites, to apply the adhesive pads in such a way that their contact surface with the skin is maximum. The
choice of power to supply is at the discretion of the operator.
9-1
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