Information On Electromagnetic Compatibility (Emc); Order Information - Servona digital XL Manual De Instrucciones

12.1 Information on electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special precautions regarding EMC and must be installed
in accordance with the EMC instructions below. Portable and mobile RF communication devices may
affect medical electrical equipment. The use of accessories, transformers and power supplies other than
those specified in this manual may result in increased signal emissions or reduced interference resi-
stance of the device or system.
Guidelines and manufacturer's declaration – electromagnetic emissions
The electrical components of the SERVOX digital XL are intended for operation in an environment as specified
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below. The user of the SERVOX digital XL should ensure that it is operated in such an environment.
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Interference emissions test Compliance
RF emissions according to CISPR 11 Class B
Emission of harmonic oscillations as
Not applicable
per IEC 61000-3-2
Transmission of voltage fluctuations/
Not applicable
flicker according to IEC 61000-3-3
Recommended safety distances between portable and mobile RF telecommunication
devices and the SERVOX ® speech aids
The electrical components of the SERVOX digital XL are intended for operation in an electromagnetic environment
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where the RF disturbances are controlled. The user of the speech aids can thereby help avoid electromagnetic in-
terference by maintaining the minimum distance between portable and mobile RF telecommunications equipment
(transmitters) and the speech aids, depending on the output power of the communication device, as indicated
below.
Safety distance depends on the transmission frequency (m)
Nominal power of
150 kHz to 80 MHz
the transmitter (W)
d = { 6/10 } √
0.01 0.06
0.1 0.19
1 0.6
10 1.90
100 6.00
For transmitters whose maximum rated power is not listed above, the recommended safety distance can be deter-
mined using the equation in the corresponding column. P is the maximum nominal power rating of the transmitter in
watts (W) according to the transmitter manufacturer's specifications.
Guidance and manufacturer's declaration – electromagnetic immunity
The electrical components of the SERVOX ® digital XL are intended for operation in an environment as specified
below. The customer or the user of the SERVOX ® digital XL should ensure that it is operated in such an environ-
ment.
Immunity IEC 60601 – Compliance
testing test level level
±8 kV ±8 kV
Electrostatic discharge
Contact discharge Contact discharge
(ESD) according to
±15 kV ±15 kV
IEC 1000-4-2
Air discharge Air discharge
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Electromagnetic environment – guidance
The SERVOX ® digital XL is suitable for use in
all settings, including in residential areas and
those directly connected to a public supply grid
that also supplies buildings used for residential
purposes.
80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = { 6/10 } √ d = { 6/10 } √
0.06 0.06
0.19 0.19
0.6 0.6
1.90 1.90
6.00 6.00
Electromagnetic environment –
guidance
Floors should be made of wood, con-
crete or ceramic tile. If the floor is lined
with a synthetic material, the relative
humidity must be at least 30 %.
Guidance and manufacturer's declaration – electromagnetic immunity
The electrical components of the SERVOX ® digital XL are intended for operation in an environment as specified
below. The customer or the user of the SERVOX digital XL should ensure that it is operated in such an environment.
®
Immunity IEC 60601 – Complian-
testing test level ce level
Magnetic fields at
the supply frequency
30 A/m 30 A/m
(50/60 Hz) according
to IEC 31000-4-8
Emitted RF
10 V/m
disturbances 10 V/m
80 MHz to 2.5 GHz
as per IEC 61000-4-3

13 Order information

Individual components of the SERVOX ® digital XL, individual spare parts and additional accessories
adapted for use with the SERVOX digital XL can be ordered separately.
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Designation
SERVOX ® digital XL speech aid complete set
Accessories and spare parts
SERVOX digital XL screw cap hard tone
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SERVOX digital XL screw cap soft tone
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SERVOX digital XL oral tube with adapter
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SERVOX ® digital XL strap set
SERVOX ® digital XL belt pouch
SERVOX digital XL battery holder
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Rechargeable battery type AAA
Charger Varta LCD plug
kwmobile universal travel adapter
SERVOX digital XL instruction manual
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DS SERVOX digital XL – First Steps for Using (DE/GB)
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SERVOX ® digital XL bottom cover
SERVOX ® digital XL O-ring
Additional accessories can be ordered:
SERVOX ® digital XL data cable
SERVOX ® digital XL software
Note
The accessories are adapted for use with the SERVOX Digital XL. Non-approved accessories may
impair the functions or damage the speech aid.
• Only use the speech aid with the approved accessories!
Only use approved accessories and spare parts from Servona!
Electromagnetic environment –
guidance
Magnetic fields at supply frequency should
correspond to typical values for business and
hospital environments.
Suggested safety distance:
d = { 6/10 } √P
d = { 6/10 } √P for 80 MHz to 800 MHz
d = { 6/10 } √P for 800 MHz to 2.5 GHz
P is the nominal power rating of the transmit-
ter in watts (W) according to the transmitter
manufacturer's specifications, and d is the re-
commended safety distance in meters (m). EN
CPN Order no.
14162696 37575
14162746
22774
14162723 23285
14162700 18253
– 17093
– 16555
– 37574
– 37561
– 41370
– 37512
– 37731
– 37595
37505
–
– 14831
14162717 37535
– 38029
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