Safety, EMC & Biocompatibility
1) This device is Class II equipment with type BF applied part. The light treatment
attachment and electrical muscle stimulation treatment attachment were
considered as one type BF applied part. It complies with Medical Electrical Safety
Standards (IEC 60601-1, IEC 60601-2-10).
2) This device is also complied to Medical EMC Standard (IEC 60601-1-2).
3) All the user directly contracting materials for main device housing and output
contacts in this device are biocompatible for its intended use. They are complied
with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10
(Irritation and Sensitization).
Guidance and manufacturer’s declaration – electromagnetic emissions
The LuminaNRG Evolution (Model: LuminaNRG Evolution) is intended for use in
the electromagnetic environment specified below. The customer or the user of the
LuminaNRG Evolution (Model: LuminaNRG Evolution) should assure that it is used
in such an environment.
Emissions Compliance Electromagnetic environment-- guidance
RF
emissions
CISPR 11
Group 1
The LuminaNRG Evolution (Model: LuminaNRG
Evolution) 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
Class A
Harmonic
emissions
IEC
61000-3-2
Voltage
fluctuations/
flicker
emissions
IEC
61000-3-3
Not
Applicable
The LuminaNRG Evolution(Model: LuminaNRG
Evolution) 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.
Guidance and manufacturer’s declaration – electromagnetic immunity
The LuminaNRG Evolution (Model: LuminaNRG Evolution) is intended for use in the
electromagnetic environment specified below. The customer or the user of the
LuminaNRG Evolution (Model: LuminaNRG Evolution) should assure that it is used in
such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment
--guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical
fast transient
/burst IEC
61000-4-4
±2 kV for
powersupply
lines
±1 kV for
input/output
lines
Not
Applicable
Not
Applicable
Not
Applicable
Mains power quality should be that of
a typical commercial or hospital
environment
Surge
IEC
61000-4-5
± 1 kV
line(s) and
neutral
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions
andvoltage
variations
on power
supply input
lines IEC
61000-4-11
<5 % UT
(>95 % dip
in UT)for 0,5
cycle
40 % UT(60
% dip in UT)
for 5 cycles
70 % UT(30
% dip in UT)
for 25 cycles
<5 % UT
(>95 % dip
in UT)for 5s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
LuminaNRG Evolution (Model:
LuminaNRG Evolution) requires
continued operation during power
mains interruptions, it is recommend-
ed that the LuminaNRG Evolution
(Model: LuminaNRG Evolution) be
powered from an uninterruptible
power supply or a battery.
Power
frequency
(50/60 Hz)
magnetic
fieldIEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level
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