User's Manual

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Caution: it is customer’s responsibility to assure that this equipment and vicinity equipment comply with the
contents of IEC 60601-1-2 4th Edition.
Caution: do not use any device that might send out RF signals, including cell phone, radio transceiver and radio
control products, which might cause operation parameters beyond the standards. Please shutdown these devices when you
are near the equipment. The clinician has the responsibility to warn user or any others to comply with this rule.
Caution: manufacturer will not be responsible for any unauthorized actions that cause interference.
Table 1
Table 2
Guidance and manufacture’s declaration – electromagnetic immunity
The XFT-2003EA Nerve and Muscle Stimulator is intended for use in the electromagnetic environment specified below.
The customer or the user should comply to specifications ensuring the device is only used in an appropriate
environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV,
±15 kV air
±8 kV contact
±2kV, ±4kV, ±8kV,
±15 kV air
Floors should be wood, concrete or ceramic tile.
Humidity should be at least 30% if it is synthetic
materials.
Electrical fast
transients/bursts
(EFT)
IEC 61000-4-4
±2kV
100kHz repetition
frequency
±2kV
100kHz repetition
frequency
Main power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±0.5kV, ±1kV
±0.5kV, ±1kV
Guidance and manufacture’s declaration – electromagnetic emission
The XFT-2003EA Nerve and Muscle Stimulator is intended for use in the electromagnetic environment specified below.
The user should comply to specifications ensuring the device is only used in an appropriate environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
This equipment uses RF energy only for its internal function. Its RF
emissions are very low and are not likely to cause any interference in
nearby electronic.
RF emission
CISPR 11
Class B
This equipment is suitable for domestic establishments and those directly
connected to the public low-voltage power supply network.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complied