Bioness VEC-1000, Руководство для клиницистов

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Chapter 15 - Electromagnetic Compatibility (EMC) Information
Chapter
15
Electromagnetic Compatibility (EMC)
Information
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The Vector Elite System is a body weight support system designed to accelerate physical rehabilitation
of patients with severe gait and/or balance impairment. The system unloads a programmed amount
of the patient’s weight thus enabling the patient to practice walking with less than a full body weight.
Emissions Test Compliance Electromagnetic Environment — Guidance
RF emissions
CISPR 11
Group 1 The Vector Elite System uses RF energy only for
communication. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
Harmonic
emissions IEC
61000-3-2
Class A The Vector Elite System is intended to be used in a hospital
/ Professional Healthcare facility environment.
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration—
Electromagnetic Immunity for All Equipment and Systems
The Vector Elite System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Vector Elite System should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment—
Guidance
Electrical fast
transient/burst
IEC 61000-4-4
+/-2 kV for power
supply lines
+/- 1 kV for Input/
output lines
+/- 2 kV for power
supply lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+/-1 kV line to line
+/-2 kV line to earth
+/-1 kV line to line
+/-2 kV line to
earth
Mains power quality should be that
of a typical commercial or hospital
environment.