User manuel
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exception of cables sold by the manufacturer as replacement parts for internal components,
may result in increased emission or decreased immunity of the device.
* Do not use a microwave, TV antenna, cordless phone, wireless router or other devices that emit electromagnetic fields, near
the unit. This may result in incorrect operation of the unit.
* This device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary,
this device sho
uld be observed to verify normal operation in the configuration in which it will be used.
* Refer to further guidance below regarding the EMC environment in which the device should be used.
There is no guarantee that interference will not occur in a particular installation. Radiated or conducted electromagnetic
signals can cause:
1) As to devices:
• The device has passed EMC highest interference level test, and the parameters do not deviate the IEC 60601-2-10
requirement.
• The device displays abnormally in LCD.
2) As to patients:
• The sensitivity of stimulation may be weaker or stronger, but it does not produce safety issues.
• It cannot achieve expected effect.
If this equipment is found to cause or respond to interference, attempt to correct the problem by one or more of the following
measures:
• If feeling too weak or too strong stimulation, adjust the strength level to an acceptable level.
• If the device display is abnormal, power off and re
start the device and check whether it shows properly.
• Re-orient or re-locate the affected device.
• Increase the separation between the unit and the affected device.
• Power the equipment from a source other than that of the affected device.
• Consult the service representative for further suggestions.
1) Guidance and manufacture’s declaration - electromagnetic emission
The TENS and Muscle Stimulator is intended for use in the electromagnetic environment specified
below. The customer of the
user of the TENS and Muscle Stimulator should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1
The TENS and Muscle Stimulator uses RF energy only for its
internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
RF emission CISPR 11 Class B The TENS and Muscle Stimulator is suitab
le for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Complies
2) Guidance and manufacture’s declaration - electromagnetic immunity
The TENS and Muscle Stimulator is intended for use in the electromagnetic environment specified below. The customer or the
user of TENS and Muscle Stimulator should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
Electromagnetic environment -
guidance
Electrostatic ±6 kV contact ±8 kV contact Floors should be wood, concrete or
manual