DEFIBRILLATOR MONITOR
Mod. 3850B-BIPHASIC - USER MANUAL
Page 21 of 63
2. INSTALLING AND TURNING ON THE DEVICE
2.1. INSTALLING
WARNING
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You should read this manual before beginning installation and use of equipment.
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This equipment is meant to be used by persons trained in professional health care.
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Defibrillator Monitor Mod. 3850B-Biphasic use is limited to a single patient at a time.
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This equipment must be used in conjunction with signs and symptoms of the patient. The equipment is designed to be an aid in
clinical diagnosis.
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Do not reuse any element disposable or single use. The time limit of use thereof is that indicated by the manufacturer.
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The expiration date of this equipment is of 5 years from its purchase, when that time is over, dismiss the equipment and it’s
accessories following the local regulations in force.
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In case of discarding the equipment or one of its accessories, at the end of its useful life, do it according to the local regulations,
normative or laws in force.
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In order to take care of the environment, you can send the equipment to
feas
ELECTRÓNICA
for its disposal.
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RISK OF ELECTRICAL SHOCK, if you remove the equipment’s lead. Do not remove the equipment’s lead. Ask for assistance from
qualified and authorized personnel.
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There is a risk of Electrical Shock and death. Do not use this equipment if you doubt of the integrity of any cable. Check the cables
periodically (disconnect them before) to verify their integrity; paying special attention to cable points close to connectors and paddles.
In case you find an irregularity, request the part to our Customer’s Service.
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Do not touch the Power Line connectors with wet hands.
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The Defibrillator Monitor Mod 3850B-Biphasic is designed with covers and plastic handles to minimize the risk of electrical shock.
When it is not plugged to the line power its energy will be provided by the battery, without ground reference.
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All combinations of medical equipment with non-medical equipment must comply with the total leakage current specified in IEC
60601-1, Cl. 16.
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When combined instruments, the sum of the leakage currents can be dangerous for both the patient and the operator. If you can’t
determine the leakage current of each team on the specifications of each, technical staff will take measurements to ensure the
installation complies with the requirements of EN 60601-1, Cl. 16. In any case, the user should consult the manufacturer to ensure
that the sum of leakage currents will not jeopardize patient safety.
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The device is intended to be connected to:
- Installations in medical rooms belonging to Groups 0, 1, 2a and 2b, according to AEA90364-7-710 (IEC 60364-7-710).
- Installations according to AEA90364-7-771, installations in buildings in general, to grounded outlets according to IRAM 2071.
- Mobile units, to the cigarette lighter connector of the vehicle.
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The disconnection of the equipment from the Power Line does not de-energize it, since it has an internal battery, so you must also
set the selector switch to OFF.
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Caution, leave one end of the power cord accessible so that in the event of an emergency, it is easy to disconnect the equipment
from the Power Line.
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Do not disconnect power by pulling the cord. Disconnect the connector firmly grasping.
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Do not excessively bend the plug or power cord or place heavy objects on them, which could cause damage.
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Do not immerse the electrical connector in liquids. This can damage the cable or connector by corrosion.
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RISK OF FIRE AND/OR EXPLOSION: do not use this equipment in the presence of flammable gases (anesthetics, oxygen, etc).
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Not use or store inflammable substances near the equipment.
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Avoid installing this equipment in places where liquids can be spilled on it. Avoid direct exposure to splatter, sprayer or air vented
from nebulizers or humidifiers.
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Do not place containers with water, chemicals or any small metal objects on the equipment.
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Do not use this equipment under the rain. You have to make sure that the equipment, the cables and paddles are dry before you
start using them.
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Do not place the equipment on the patient or where it can fall over the patient. Place it next to the patient where it’s comfortable for
its use.
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Never attempt to introduce sharp, metallic or other objects into any aperture on the equipment.
CAUTION
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The performance of equipment might be affected by the presence of CAT scanner.
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Do not use this equipment near Magnetic resonance imaging equipment (MR o MRI).
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To attach wires and sensors always use hypoallergenic tape.
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Do not store the equipment in deposits or between periods of use in places where the sun shine directly on it. Risk of damage to the
cover of the equipment, parts and accessories.
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Avoid installing this equipment in those places where the sun hits directly.
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Do not place heavy objects on the equipment.
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Do not drop the equipment when moving it.
