Cardiac Science Burdick 8300, Инструкция по безопасности продукта

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70-01047-01 B
Product Safety and Setup
12
Using multiple electrical apparatus
!
WARNING! Shock hazard.
If connecting the ECG device to non-medical equipment, use only
non-medical equipment compliant with IEC 60950 or 60601-1.
In addition, the enclosure leakage current of non-medical
equipment connected to the ECG device must not exceed 150μA
in fault condition.
If necessary, use an additional isolating transformer or floating
power supply to maintain a proper enclosure leakage current and
provide additional protection.
!
WARNING! Patient safety.
Non-medical equipment connected to the ECG device must be
outside the patient’s vicinity: 6 feet (1.83 m) beyond the perimeter
of the bed, table, or chair, and 7 1/2 feet (2.29 m) above the floor.
!
WARNING! Misdiagnosis.
Electromagnetic interference may cause trace noise or input
overload conditions. This may be caused by the presence of strong
EMI fields, or generated by RF noise on the line power, or by
electronic, surgical, or diathermy instruments in close proximity to
the ECG device. Position the ECG device away from other electrical
or electronic equipment, if possible.
If used with, or around, other electrical or electronic equipment,
always carefully monitor initial readings to verify normal
operation.
The ECG device is compliant with IEC 60601-1-2 EMC immunity
requirements. Refer to
EMC guidelines on page 39.
To prevent excessive patient leakage current ensure all patient
equipment meets certified IEC medical standards.
Note: The ECG device patient leads are electrically isolated from
ground and the device meets IEC medical standards for leakage
current.