A.M.I Italia Saver One P, User Manual

Page: 9 / 81

9
2 S
AFETY INSTRUCTIONS
For correct use of the Saver One P defibrillator, users must be aware of the safety factors listed below.
We recommend that you read them carefully.
The Saver One P defibrillator, individually and in connection with its standard and optional (original) accessories,
complies with the safety regulations currently in force and with the provisions of the directives on medical products.
The appliance and its accessories are to be considered safe in the case of application according to the provisions and if
the descriptions and indications in this user manual are complied with.
The following are the main precautions to be taken for the correct and safe use of the defibrillator, broken down for
ease of referencing into hazard statements, warning statements and disposal instructions.
2.1 HAZARD
STATEMENTS
➢
Use the Saver One P in accordance with the requirements of this user manual. Carefully read these instructions for use
and in particular the safety instructions indicated therein.
➢
In accordance with IEC/EN standards (section 3.2), the use of the Saver One P device or its accessories in the presence of
flammable substances (petrol or similar) or in an atmosphere enriched with oxygen or flammable gases/vapours is not
allowed.
➢
Do not recharge SAV-C0903 and SAV-C0904 disposable batteries. Explosion hazard!
➢
Avoid contact of the batteries with naked flames. Do not expose to fire.
➢
Do not cause a short-circuit of the battery terminals.
➢
In case of leakage of fluids or strange odours from the batteries, keep them away from fire to prevent any leaking
electrolytes from igniting.
➢
Shock hazard. The device generates high voltage and hazardous current levels. Do not open the Saver One P , do not
remove the panels and do not attempt to repair it. The Saver One P contains no components that users can repair. For
repair purposes, the Saver One P must be sent to an authorized technical support centre.
➢
Do not apply the electrodes to the patient's chest if nitro-glycerine patches are present. Only place the electrodes once
you have removed the plasters. Otherwise there is a risk of causing an explosion.
➢
Do not touch the patient and prevent third parties from coming into contact with the patient during the defibrillation
shock. Avoid all contact between:
•
parts of the patient’s body
•
conducting liquids (such as gel, blood, or saline solution)
•
metal objects near the patient (such as bed frame or stretching device) that are indirect routes for the
defibrillation current.
➢
Before using the device ensure the patient’s safety, if necessary move them carefully and put them in a safe place as per
the international guidelines AHA/ERC.
➢
Do not immerse any part of the Saver One P , its parts or accessories in water or other liquids.
➢
Do not allow liquids to enter the Saver One P , its parts or accessories. Avoid pouring liquids on the device and its
accessories. Failure to do so may cause damage or cause a risk of fire or electric shock. Do not sterilize the Saver One P or
its accessories.
2.2 WARNINGS
➢
Avoid the formation of air bubbles between the skin and the defibrillation pads. The formation of air bubbles during
defibrillation may cause severe burns to the patient’s epidermis. To avoid the formation of air bubbles, make sure that
the electrodes fully adhere to the skin. Do not use electrodes whose gel has dried; check the expiration date before use.
➢
Do not delay treatment in patients with an implanted pacemaker and perform a defibrillation attempt if the patient has
lost consciousness and is not breathing or not breathing normally. The
Saver One P is equipped with a pacemaker
detection system that ignores the signal it emits; however, with some types of pacemakers, the Saver One O may
advise against a defibrillation shock.
During the application of the electrodes:
• Do not apply the electrodes directly on an implanted device.
• Apply the electrodes at least 2.54 cm (1 inch) from any implanted device
➢
RF (radio frequency) interference, caused by devices such as mobile phones and two-way radios, can cause the Saver
One P to malfunction. The Saver One P must be kept at least 2 metres away from these RF devices, as indicated in the
standards IEC/EN 61000-4-3. Keep at sufficient distance from other therapeutic and diagnostic sources of energy (e.g.
diathermy, high-frequency surgery, magnetic tomography).
➢
Use the Saver One P only if you have passed a BLS-D or ALS-D training course.
➢
Before using the device, make sure that it is not obviously damaged.