User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
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1.3 USAGE RESTRICTIONS AND SAFETY PRECAUTIONS
In order to guarantee the patient’s and the user’s safety as well as a correct
working of the equipment, it is necessary to operate within the consented
restrictions and adopt all the precautions listed below:
ATTENTION
Prior to usage, verify that all the safety requirements are satisfied.
The equipment must not be supplied by or connected to other instruments until
such safety conditions are restored.
1.3.1 ELECTRIC SAFETY
Leakage current
The maximum patient leakage current from the equipment, measured according to
the IEC 60601-1 standard (for Type BF) is less than 100 A.
However take care when using the equipment at the same time with other
instruments. In the event the patient is connected to several instruments at the
same time, it is necessary to remember that the sum of the leakage currents
determined by each instrument may exceed this value.
Patient Connection
All patient connections to the equipment are through the device using the proper
adhesive electrode patch provided. Any patient electrodes connected to the device
by any other means may constitute an unsafe condition that could result in injury
or death to the patient.
ATTENTION
All patient connections on the device are isolated from AC power ground.
Do NOT join these connections to earth ground or AC power ground since such an
action constitute an unsafe condition that could result in serious injury or
accidental death to the patient.
ATTENTION
The electrode through which the signal is captured from the body of the patient are
not part of the amplifier system, in any case it is MANDATORY to use only
electrode or sensor approved for commercial use by FDA (USA) or/and CE marked
(93/42 EEC directive and following amendment 2007/47/EC).