Orbisana SERVOX digital XL Manual Del Usuario página 13

12 Technical data
Dimensions L 128 x Ø 35 mm
Weight approx. 110 g without rechargeable batteries/batteries
Application parts SERVOX ® digital XL speech aid, SERVOX
Housing and adapter: BBS plastic, Protective sleeve: Titanium, Screw cap hard: Polymethyl met-
Material hacrylate (PMMA), Screw cap soft: Thermoplastic elastomers/polypropylene (TPE/PP), Oral tubes:
Silicone
Specifications for rechargeable batteries/batteries
Voltage: 1.2 V/1.5 V
Typ. capacity: 750 mAh – 900 mAh
Rechargeable battery type: AAA NiMh (HR03)
Typ. battery life: ≤ 1000 cycles
Other notes
The talk time depends on the selected battery capacity. The battery life specified by the manufacturer must be observed. The batteries supplied
by Orbisana Healthcare GmbH meet the safety requirements of IEC 62133. All replacement batteries must meet this standard.
Due to country-specific requirements, the speech aid is delivered with different accessories.
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 resistance 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 below. The user of the SERVOX
®
should ensure that it is operated in such an environment.
Interference emissions test Compliance
RF emissions according to CISPR 11 Class B
Emission of harmonic oscillations as per
Not applicable
IEC 61000-3-2
Transmission of voltage fluctuations/flicker
Not applicable
according to IEC 61000-3-3
Recommended safety distances between portable and mobile RF telecommunication devices and the SERVOX
The electrical components of the SERVOX ® digital XL are intended for operation in an electromagnetic environment where the RF disturbances are controlled.
The user of the speech aids can thereby help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF tele-
communications 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 the
150 kHz to 80 MHz 80 MHz to 800 MHz
transmitter (W)
d = { 6/10 } √ d = { 6/10 } √
0.01 0.06 0.06
0.1 0.19 0.19
1 0.6 0.6
10 1.90 1.90
100 6.00 6.00
For transmitters whose maximum rated power is not listed above, the recommended safety distance can be determined using the equation in the corre-
sponding 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 environment.
Immunity testing IEC 60601 – test level Compliance level
Electrostatic discharge (ESD) ±8 kV Contact discharge ±8 kV Contact discharge
according to IEC 1000-4-2 ±15 kV Air discharge ±15 kV Air discharge
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® digital XL screw caps, SERVOX ® digital XL oral tubes
digital XL
®
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.
® speech aids
800 MHz to 2.5 GHz
d = { 6/10 } √
0.06
0.19
0.6
1.90
6.00
Electromagnetic environment – guidance
Floors should be made of wood, concrete or ceramic tile. If
the floor is lined with a synthetic material, the relative humi-
dity 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 testing IEC 60601 – test level
Magnetic fields at the supply
frequency (50/60 Hz) according to 30 A/m
IEC 31000-4-8
10 V/m
Emitted RF disturbances as per
IEC 61000-4-3 80 MHz to 2.5 GHz
13 Order information
Individual components of the SERVOX ® digital XL, individual spare parts and additional accessories adapted for use with the SERVOX
XL can be ordered separately.
Designation
SERVOX ® digital XL speech aid complete set
SERVOX digital XL Basic – Basic set without charger, adapter and batteries (Australia only)
®
Accessories and spare parts
SERVOX ® digital XL screw cap hard tone
SERVOX ® digital XL screw cap soft tone
SERVOX digital XL oral tube with adapter
®
SERVOX digital XL strap set
®
SERVOX ® digital XL belt pouch
SERVOX ® digital XL battery holder
Rechargeable battery type AAA
Charger Varta LCD plug
ANSMANN Travel Adapter All in One 2
SERVOX ® digital XL instruction manual
DS SERVOX ® digital XL – First Steps for Using (DE/GB)
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 ®
speech aid.
• Only use the speech aid with the approved accessories!
• Only use approved accessories and spare parts from Orbisana Healthcare!
14 Disclaimer
Repairs or modifications to the SERVOX digital XL or its components/accessories by persons not authorised by Orbisana Healthcare GmbH are
®
prohibited. In the event of damage, the manufacturer does not assume liability in case of non-compliance with the instruction manual or the
safety instructions or manipulation of the product. In the event of non-observance or repairs or modifications to the SERVOX
components/accessories by unauthorised persons will invalidate the warranty.
Only original spare parts and accessories may be used. The warranty is 24 months for parts and material. Excluded are wear parts and consu-
mables. Shipping costs are the responsibility of the owner or warranty claimant. The warranty period begins on the date of delivery.
Compliance level Electromagnetic environment – guidance
Magnetic fields at supply frequency should correspond to
30 A/m
typical values for business and hospital environments.
Suggested safety distance:
d = { 6/10 } √P
d = { 6/10 } √P for 80 MHz to 800 MHz
10 V/m d = { 6/10 } √P for 800 MHz to 2.5 GHz
P is the nominal power rating of the transmitter in watts (W)
according to the transmitter manufacturer's specifications,
and d is the recommended safety distance in meters (m).
CPN Order no.
14162696 37575
38035
–
14162746 22774
14162723 23285
14162700 18253
– 17093
– 16555
– 37574
– 37561
– 41370
– 45210
– 37731
– 37595
– 37505
– 14831
14162717 37535
– 38029
digital XL. Non-approved accessories may impair the functions or damage the
®
EN
® digital
digital XL or its
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