1byone TENS Bedienungsanleitung Seite 6

Program
EN
Mode 1: TENS and EMS
DE
Mode 2: TENS
Mode 3: EMS
FR
Mode 4: TENS
Mode 5: TENS
ES
Mode 6: TENS
Mode 7: EMS
IT
Mode 8: TENS
The Electronic TENS Therapy Pain Relief Kit is compliant with:
• Medical Devices Directive 93/42/EEC
• IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
• IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
• IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part 2-10: Particular
requirements for the safety of nerve and muscle stimulators
Electromagnetic Compatibility and FCC Compliance Statement
1. This product needs special precautions regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC information provided, and this device can be
affected by portable and mobile radio frequency (RF) communications equipment.
2. Do not use a mobile phone or other devices that emit electromagnetic fields near this device. This may
result in incorrect operation of this device.
3. Caution: This device has been thoroughly tested and inspected to assure proper performance and
operation.
4. Caution: This device should not be used adjacent to or stacked with other equipment, and 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.
Guidance and manufacturer's declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The customer of
the user of the device should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
The device uses RF energy only for its internal function. Therefore, its RF emissions are
RF emissions Group 1
very low and are not likely to cause any interference in nearby electronic equipment.
CISPR 11
RF emission Class B
The device is suitable for use in all establishments, including domestic establishments
CISPR 11
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic
emissions
Class A
IEC 61000-3-2
Voltage
fluctuations
/flicker
Complies
emissions
IEC 61000-3-3
Pulse frequency (Hz)
Combination of the following
69
13-56
1.2
100 (On for 10 sec and off for 2.5 sec)
100 (On for 20 sec and off for 1 sec)
20
160
08
Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test Compliance level Electromagnetic environment - guidance
level
Electrostatic ±6 kV contact ±6 kV contact
discharge (ESD) ±8 kV air ±8 kV air
IEC 61000-4-2
Electrical fast ±2 kV for power ±2kV for power
transient supply lines supply lines
/burst ±1 kV for input
IEC 61000-4-4 /output lines
Surge ± 1 kV line(s) to ±1 kV differential
IEC 61000-4-5 line(s) mode
± 2 kV line(s) to
earth
Voltage dips, short <5% UT <5% UT
interruptions and (>95% dip in UT) (>95% dip in UT)
voltage variations for 0.5 cycle for 0.5 cycle
on power supply
input lines 40% UT 40% UT
IEC 61000-4-11 (60% dip in UT) (60% dip in UT)
for 5 cycles for 5 cycles
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m
(50Hz/60Hz)
magnetic field IEC
61000-4-8
Conducted RF 3 Vrms
3 Vrms
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 2.5
GHz
09
Floors should be wood, concrete or ceramic
tile. If floor are covered with synthetic
material, the relative humidity should be at
least 30%.
Power outlet quality should be that of a
typical commercial or hospital environment.
Power outlet quality should be that of a
typical commercial or hospital environment.
Power outlet quality should be that of a
typical commercial or hospital environment.
If the user of the device requires continued
operation during power outlet interruptions,
it is recommended that the device be
powered from an uninterruptible power
supply or a battery.
NOTE UT is the a.c. mains voltage prior to
application of the test level.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
EN
DE
FR
ES
IT