Emission test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1
RF emission CISPR 11 Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Complies
2726
14. Disposal of the Unit
To dispose of the unit, its accessories and packing materials, take appropriate
actions in accordance with the rules and regulations in force in your area to
prevent adverse ecological effects.
15. Warranty period
We give a warranty of 1 years from the date of purchase on Pch Life TENS &
PMS.This warranty does not cover cables and electrodes.
16. Electromagnetic Compatibility
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC and mobile
(cellular) telephones, radio transceivers, mobile radio transmitters,
radio-controlled toys, and so on, Medical devices in use may be susceptible to
electromagnetic interference from other device. Electromagnetic interference
may result in incorrect operation of the medical devices and create a
potentially unsafe situation. Medical devices should also not interfere with
other devices.
In order to regulate the requirements for EMC (Electro Magnetic
Compatibility) with the aim to prevent unsafe product situations, the
EN60601-1-2 standard has been implemented. This standard defines the levels
of immunity to electromagnetic interference as well as maximum levels of
electromagnetic emissions for medical devices.
This unit has been thoroughly tested and inspected to assure proper
performance and operation! This product needs special
precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided,
the following tables recommend minimum separation distances between
portable and mobile RF communications equipment and the TENS unit.
Caution:
* The use of accessories and cables other than those specified by Pch Life,
with the exception of cables sold by Pch Life as replacement parts for internal
components, may result in increased emission or decreased immunity of the
device.
* Do not use a mobile phone 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 should 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:
• Deviation of the values of pulse duration, amplitudes, and repetition
frequencies, may impair the unit’s essential performance. The device has
passed EMC highest interference level test, and the parameters do not deviate
the essential performance 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 restart 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 Pch Life TENS & PMS is intended for use in the electromagnetic
environment specified below. The customer of the user of the
Pch Life TENS & PMS should assure that it is used in such an environment.
The Pch Life TENS & PMS 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.
The Pch Life TENS & PMS is suitable 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.
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