Potential Complications; Product Life And Storage - Progetti Rescue Life 9 Instructions For Use Manual

Defibrillator
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ATTENTION
Paediatric multifunction electrodes marked with the symbol shown beside are indicated
for use with automatic defibrillators.
• The electrode choice should be based on the evaluation of chest size and weight of the patient. Paediatric
electrodes used beyond the specified energy limit may cause also major skin burns; on the contrary the
extended active surface of adult electrodes may jeopardize the therapy when used for pediatric
treatment.
• After an extended period of transthoracic pacing the ability to detect the evoked ECG signal can be
reduced. In this case it is necessary to provide for the collection of the evoked signal by a separate set of
ECG electrodes.
• Replace the multifunction electrodes after 24 hours from their application on the patient's skin.
• Check the expiration date on the package. Do not use after this date.
• Do not use multifunction electrodes if removed from the envelope for more than 24 hours. The adhesive
pads are to be applied within 30 minutes after removal of the protective coating.
• Check that the packaging is intact: do not use the product otherwise.
• Do not use the multifunction electrodes if the gel is removed from the support or if it is ripped, torn or
dry. Any discoloration localized on gel or on conductive foil does not affect the functionality of the
product.
• Do not use the multifunction electrodes if during removal of the protective coating the product is
damaged (eg. the insulating coating of the contact has detached or there are tears in the foam support
and/or in the electrode).
• Do not bend, do not cut and do not squash the adhesive pads.
• Do not use the multifunction electrodes if the connector, the cable or the clips appear to be damaged.
• Check on the operating instructions of the defibrillator at which safety distances the devices (surgeon's
electric knife, RF ablators, diathermy equipment, mobile phones, etc.) that emit strong electromagnetic
interferences must be placed.
• To prevent accidental damage from electric
contact with the electrode pads, with the patient, or with conductive parts close to the patient.
• When defibrillators are used near oxygen sources or other flammable gases, use extreme care to avoid
risk of fire or explosion.
• The product neither is sterile nor can be sterilized.
• The product is disposable. For use on a single patient. Discard after use.

POTENTIAL COMPLICATIONS

There are no complications related to the use of multifunction electrodes.
ATTENTION: The defibrillator discharge may cause irregularities in the operation of an implanted
pacemaker/defibrillator [1]; apply the multifunction electrodes at a distance of at least 8cm. After
defibrillator discharge check its operation.
ATTENTION: If the chosen energy level is insufficient the success of therapy may be jeopardizing. On the
contrary, higher levels may modify the enzyme structure without actual evidence of myocardial damage.

PRODUCT LIFE AND STORAGE

Check the expiration date printed on the package.
The product should be stored in its original packaging in rooms with environment conditions of
temperature (5-35°C) and relative humidity (20-80%), specified on the label. The storage at extreme
temperatures must be limited to short periods (24 hours at -30°C or +65°C). Prolonged storage at extreme
temperatures can shorten the life of the product.
9
Rescue Life
– Instruction For Use
shock,
ensure that during discharge operators are not in
9-4
Rev.0.5 – 30/03/2022

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