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9. IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)
- The use of accessories, transducers and cables other than those mentioned or provided by
With the increased number of electronic devices such as computers and mobile (cellular)
telephones, medical devices in use may be susceptible to electromagnetic interference from
other devices. Electromagnetic interference may result in incorrect operation of the medical
device and create a potentially unsafe situation. Medical devices shouldalso not interfere with
other devices.
In order to regulate the requirements for EMC (Electromagnetic Compatibility) with the aim to
prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This
levels of electromagnetic emissions for medical devices.
The stimulator conform to this IEC60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
- The use of accessories other than those provided by manufacturer , may result in increased
emission or decreased immunity of the device.
- Refer to EMC table guidance regarding the EMC environment in which the device
should be used.
the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and increase the risk of malfunction
8. TECHNICAL CHARACTERISTICS
Units
2 Units (49.9mmx55.8mm)
Programmes
19 programmes (11 TENS + 8 EMS programmes)
Battery
3.7V/500mAh Li-lon
Output voltage
max 60mA ±10% (1000Ω load)
Conditions of use
5°C to 40°C with a relative humidity of 15% to 93%,
atmospheric pressure of 700 to 1060 hPa
Storage and Transportation Conditions
-10°C to 55°C with a relative humidity of 10% to
90%, atmospheric pressure of 700 to 1060 hPa
Dimensions
440x54x13mm cable included
Weight
55g (±20%) by unit
IP22
Wave form
Biphasic square wave (net current 0dc)
Impulse width
150us~370us (±10%)
Heart rhythm
2Hz~100Hz (±10%)
Treatment time
22min/30min given by the application
Adapter
1pc (Input : 100-240 V AC 50/60Hz Output : 5 V DC
Service life of the device
2 years
Service life of electrode pads
Applied part
Electrode size
Eelctrode impadence
10 times
Eelctrode
28*25mm(ellipse)
≤500Ω
300mA)
Guidance and manufacturer’s declaration – electromagnetic emissions
The customer or the user of these electrical stimulators should assure that it is used
in such environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The device 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 emissions
CISPR 11
Class B
The device is suitable for use in all
establishments including domestic and those
directly connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
lEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
lEC 61000-3-3
Complies
TABLE 1:
