Durr Dental VistaVox S User manual

EN
VistaVox S
Operating Instructions
0297
2210200378L02
*2210200378L02*
1907V009

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 Intended purpose and indication .. 5
2.2 Intended use .. . . . . . . . . . . . . . . 5
2.3 Improper use .. . . . . . . . . . . . . . . 5
2.4 Contraindication .. . . . . . . . . . . . 5
2.5 General safety information .. . . . . 5
2.6 Radiation protection .. . . . . . . . . 5
2.7 Specialist personnel .. . . . . . . . . 6
2.8 Electrical safety .. . . . . . . . . . . . . 6
2.9 Essential performance charac-
teristics .. . . . . . . . . . . . . . . . . . . 6
2.10 Notification requirement of seri-
ous incidents .. . . . . . . . . . . . . . . 7
2.11 Only use original parts .. . . . . . . . 7
2.12 Transport .. . . . . . . . . . . . . . . . . . 7
2.13 Disposal .. . . . . . . . . . . . . . . . . . 7
2.14 Protection from threats from the
Internet .. . . . . . . . . . . . . . . . . . . 7
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Scope of delivery .. . . . . . . . . . . . 9
3.2 Optional items .. . . . . . . . . . . . . . 9
3.3 Consumables .. . . . . . . . . . . . . . 10
4Technical data .. . . . . . . . . . . . . . . . . . . 11
4.1 X-ray tube performance data .. . . 12
4.2 Dimensions .. . . . . . . . . . . . . . . . 17
4.3 Type plate .. . . . . . . . . . . . . . . . . 18
4.4 Evaluation of conformity .. . . . . . 18
5 Operation .. . . . . . . . . . . . . . . . . . . . . . 19
5.1 Functional description .. . . . . . . . 19
5.2 Operating elements .. . . . . . . . . . 19
5.3 Status LED .. . . . . . . . . . . . . . . . 20
5.4 Positioning aids .. . . . . . . . . . . . . 20
5.5 Exposure button .. . . . . . . . . . . . 21
5.6 Memory card slot .. . . . . . . . . . . 21
5.7 Sensor window .. . . . . . . . . . . . . 21
Usage
6Operating the touch screen .. . . . . . . . 22
6.1 Navigating .. . . . . . . . . . . . . . . . . 22
6.2 Using menus .. . . . . . . . . . . . . . . 22
6.3 Calling up messages on the
touch screen .. . . . . . . . . . . . . . . 22
7 Operation .. . . . . . . . . . . . . . . . . . . . . . 23
7.1 Switch on the unit. .. . . . . . . . . . 23
7.2 Adjusting the imaging software .. 24
7.3 Inserting the positioning aids .. . . 30
7.4 Positioning the patient .. . . . . . . . 34
7.5 Start a test run .. . . . . . . . . . . . . 37
7.6 Taking the X-ray image .. . . . . . . 38
7.7 Emergency stop switch .. . . . . . . 39
8Cleaning and disinfection .. . . . . . . . . . 41
8.1 Unit surfaces .. . . . . . . . . . . . . . . 41
8.2 Positioning aids .. . . . . . . . . . . . . 41
9 Reprocessing .. . . . . . . . . . . . . . . . . . . 43
9.1 Risk analysis and categorisation .. 43
9.2 Reprocessing procedure in
accordance with EN ISO 17664 .. 43
9.3 General information .. . . . . . . . . . 44
9.4 Preparation at the operating
location .. . . . . . . . . . . . . . . . . . . 44
9.5 Manual cleaning, intermediate
rinsing, disinfection, final rinse,
drying .. . . . . . . . . . . . . . . . . . . . 44
9.6 Automatic cleaning, intermediate
rinsing, disinfection, final rinse,
drying .. . . . . . . . . . . . . . . . . . . . 45
9.7 Check for function .. . . . . . . . . . . 45
9.8 Steam sterilising .. . . . . . . . . . . . 45
9.9 Issue clearance for the parts for
sterilisation .. . . . . . . . . . . . . . . . 46
9.10 Storing parts for sterilisation .. . . 46
10 Maintenance .. . . . . . . . . . . . . . . . . . . . 47
Contents
2210200378L02 1907V009 1
EN

10.1 Recommended maintenance
schedule .. . . . . . . . . . . . . . . . . . 47
Troubleshooting
11 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 49
Appendix
12 Program parameters .. . . . . . . . . . . . . . 51
12.1 CBCT program parameters .. . . . 51
12.2 Panoramic program parameters .. 52
13 Information on scattered radiation .. . 53
13.1 CBCT scattered radiation .. . . . . 53
13.2 Pano scattered radiation .. . . . . . 53
14 Information on the leakage rate .. . . . . 54
Contents
2 2210200378L02 1907V009
EN

Important information
1 About this document
These installation and operating instructions form
part of the unit.
If the instructions and information in these
operating instructions are not followed,
Dürr Dental will not be able to offer any
warranty or assume any liability for the
safe operation and the safe functioning of
the unit.
The German version of the operating instructions
is the original manual. All other languages are
translation of the original manual.
These operating instructions are valid for
VistaVox S, order number: 2210200001.
Refer to the separate installation instructions for
information about assembly, installation and con-
figuration of the unit (document no.
2210200379).
1.1 Warnings and symbols
Warnings
The warnings in this document are intended to
draw your attention to possible injury to persons
or damage to machinery.
The following warning symbols are used:
General warning symbol
The warnings are structured as follows:
SIGNAL WORD
Description of the type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
❯Follow these measures to avoid the
danger.
The signal word differentiates between four levels
of danger:
–DANGER
Immediate danger of severe injury or death
–WARNING
Possible danger of severe injury or death
–CAUTION
Risk of minor injuries
–NOTICE
Risk of extensive material/property damage
Other symbols
These symbols are used in the document and on
or in the unit:
Note, e.g. specific instructions regarding
efficient and cost-effective use of the unit.
Order number
Serial number
Medical device
CE labelling with the number of the noti-
fied body
Manufacturer
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Type BF application part
Do not reuse
Not sterile
Steam sterilise at 134 °C
Protective ground connection
Equipotential bonding
Important information
2210200378L02 1907V009 3
EN

Fragile, handle with care
XX
YY
Lower and upper atmospheric pressure
limits
XX
YY
Lower and upper temperature limits
no condensation
XX
YY
Lower and upper humidity limits
n
Stacking limits
Recycling
Keep dry
This way up / store and transport in an
upright position
Keep away from sunlight
Refer to Operating Instructions.
Wear protective gloves.
Wear protective goggles.
Use a mask.
Use protective clothing.
Disconnect all power from the unit.
Notice
Emergency stop switch
Laser class 1 product
CAUTION
X-RAYATTENTION: X-RAY
ONWHEN EQUIPMENT IN
OPERATION
Warning – X-rays
Warning – dangerous high voltage
Warning – X-rays
1.2 Copyright information
All circuits, processes, names, software pro-
grams and units mentioned in this document are
protected by copyright.
The Installation and Operating Instructions must
not be copied or reprinted, neither in full nor in
part, without written authorisation from Dürr
Dental.
Important information
4 2210200378L02 1907V009
EN

2 Safety
The unit has been developed and designed in
such a way that dangers are effectively ruled out
if used in accordance with the Intended Use.
Despite this, the following residual risks can
remain:
– Personal injury due to incorrect use/misuse
– Personal injury due to mechanical effects
– Personal injury due to electric shock
– Personal injury due to radiation
– Personal injury due to fire
– Personal injury due to thermal effects on skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Intended purpose and indica-
tion
Creation of 3D, panoramic and optionally
cephalometric X-ray images in dental radiogra-
phy for adult and adolescent patients.
2.2 Intended use
The unit must only be used by dentists or dental
assistants who have been trained in the use of X-
ray radiation in accordance with the applicable
legal requirements.
2.3 Improper use
Any use of this appliance / these appliances
above and beyond that described in the Installa-
tion and Operating Instructions is deemed to be
incorrect usage. The manufacturer cannot be
held liable for any damage resulting from incor-
rect usage. The operator will be held liable and
bears all risks.
2.4 Contraindication
The radiobiological effects of X-ray beams in tis-
sue result in the following contraindications:
– Pregnancy
– Pre-existing illnesses preventing the recording
of a CBCT image
– Absence of a justified indication
Exceptions can be formulated at the discretion of
the physician.
2.5 General safety information
❯Always comply with the specifications of all
guidelines, laws, and other rules and regula-
tions applicable at the site of operation for the
operation of this unit.
❯Check the function and condition of the unit
prior to every use.
❯Do not convert or modify the unit.
❯Comply with the specifications of the Installa-
tion and Operating Instructions.
❯The Installation and Operating Instructions
must be accessible to all operators of the unit
at all times.
2.6 Radiation protection
❯Comply with all applicable X-ray protection
rules and take all required X-ray protection
measures.
❯Use the prescribed X-ray protection equip-
ment.
❯In order to reduce the level of X-ray exposure,
we recommend the use of bismuth, lead
shielding or protective aprons, especially for
children and teenagers.
❯The persons operating the equipment must
keep away from the X-ray unit while the expo-
sure is being taken. The minimum distance
required by law must be maintained (e.g. Ger-
many 1.5 m, Austria 2.0 m).
❯Children and pregnant women must consult a
doctor before having an X-ray taken.
❯Nobody else must be in the radiation room
without X-ray protection measures apart from
the patient. In exceptional circumstances
another person may be present to provide
assistance, but this must not be a member of
the surgery staff. When the exposure is being
taken, make sure that you maintain visual con-
tact with the patient and the unit and keep talk-
ing to the patient.
❯The radiation room must be lockable to prevent
entry by unauthorised persons.
❯If a fault occurs, cancel the exposure immedi-
ately by letting go of the trigger button.
Important information
2210200378L02 1907V009 5
EN

2.7 Specialist personnel
Operation
Unit operating personnel must ensure safe and
correct handling based on their training and
knowledge.
❯Instruct or have every user instructed in han-
dling the unit.
Installation and repairs
❯Installation, readjustments, alterations,
upgrades and repairs must be carried out by
Dürr Dental or by qualified personnel specifi-
cally approved and authorized by Dürr Dental.
2.8 Electrical safety
❯Comply with all the relevant electrical safety
regulations when working on the unit.
❯Never touch the patient and unshielded plug
connections on the device at the same time.
❯Replace any damaged cables or plugs immedi-
ately.
Observe the EMC rules concerning medical
devices
The unit complies with the requirements accord-
ing to IEC 60601-1-2:2014.
❯The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the appliance is operated in
another environment, potential effects on elec-
tromagnetic compatibility must be taken into
account.
❯Do not operate the unit in the vicinity of HF sur-
gical instruments or MRT equipment.
❯Maintain a minimum distance of at least 30 cm
between the unit and other electronic devices.
❯Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
❯No maintenance measures are required to
maintain the EMV basic safety.
❯The emissions characteristics of this device
render it suitable for use in industrial environ-
ments and hospitals (CISPR 11, Class A).
When used in a residential environment (which
normally requires Class B in accordance with
CISPR 11), this device may not provide ade-
quate protection from radio communication
services. The operator may need to take cor-
rective measures such as relocating or reorient-
ing the device.
NOTICE
Negative effects on the EMC due to
non-authorised accessories
❯Use only Dürr Dental parts or acces-
sories specifically approved by Dürr
Dental.
❯Using any other accessories may result
in increased electromagnetic interfer-
ence emissions or the unit having
reduced electromagnetic immunity,
leading to an erroneous operation
mode.
NOTICE
Erroneous operation mode due to use
immediately adjacent to other devices
or with other stacked devices
❯Do not stack the unit together with
other devices.
❯If this is unavoidable, the unit and other
devices should be monitored in order
to ensure that they are working cor-
rectly.
NOTICE
Reduced performance characteristics
due to insufficient distance between
unit and portable HF communication
devices
❯Keep a distance of at least 30 cm
between the unit (including parts and
cables of the unit) and portable HF
communication devices (wireless units)
(including their accessories such as
antenna cables and external anten-
nas).
2.9 Essential performance char-
acteristics
The unit does not have any essential perfor-
mance characteristics as set out in IEC 60601-1
section 4.3.
Important information
6 2210200378L02 1907V009
EN

2.10 Notification requirement of
serious incidents
The user / patient is required to report to the
manufacturer and the competent authority of the
Member State, in which the user and/or patient is
established, any serious incident that has
occurred in relation to the device.
2.11 Only use original parts
❯Only use Dürr Dental parts or accessories and
special accessories specifically approved by
Dürr Dental.
❯Only use only original wear parts and replace-
ment parts.
Dürr Dental accepts no liability for dam-
ages or injury resulting from the use of
non-approved accessories or optional
accessories, or from the use of non-origi-
nal wear parts or replacement parts.
The use of non-approved accessories,
optional accessories or non-genuine wear
parts / replacement parts (e.g. mains
cable) can have a negative effect in terms
of electrical safety and EMC.
The following accessories can influence EMC:
– Mains cable (3.6 m; order no.: 2210200243)
– Exposure switch (order no.: 2210200313)
2.12 Transport
The original packaging provides optimum protec-
tion for the unit during transport.
If required, original packaging for the unit can be
ordered from Dürr Dental.
Dürr Dental will not accept any responsi-
bility or liability for damage occurring dur-
ing transport due to the use of incorrect
packaging, even where the unit is still
under guarantee.
❯Only transport the unit in its original packaging.
❯Keep the packing materials out of the reach of
children.
❯Reattach the transport locking devices.
❯Do not expose the unit to any strong vibrations
or shocks.
❯Do not bump or pull the unit.
2.13 Disposal
An overview of the waste keys for Dürr
Dental products can be found in the
download area at www.duerrdental.com
(document no. P007100155).
Unit
The unit must be disposed of properly.
Within the European Union, the unit must
be disposed of in accordance with EU
Directive 2012/19/EU (WEEE).
X-ray emitter
The X-ray unit contains a tube that is potentially
capable of imploding, lead cladding and mineral
oil.
2.14 Protection from threats from
the Internet
The unit is to be connected to a computer that
can be connected to the Internet. Therefore, the
system needs to be protected from threats from
the Internet.
❯Use antivirus software and update it regularly.
Look for evidence of possible virus infection
and, if applicable, check with the antivirus soft-
ware and remove the virus.
❯Perform regular data backups.
❯Restrict access to units to trustworthy users,
e.g. via a user name and password.
❯Make sure that only trustworthy content is
downloaded. Only install software and firmware
updates that have been authenticated by the
manufacturer.
Important information
2210200378L02 1907V009 7
EN

Product description
3 Overview
1
7
6
8
9
11
10
12
131416 15
2
18 17
4
5
3
1 3D and panoramic X-ray device
2 Wall bracket
3 Frame grabber card
4 USB dongle
5 USB stick with device-specific calibration
data
6 Small parts
7 VistaSoft imaging software DVD
8 Test body holder
9 Exposure switch (with holder)
10 Head support with cushion
11 Hygienic protective covers for bite block
12 Bite block
13 Adapter bite block
14 Chin holder for maxillary joint image
15 Chin holder for edentulous jaws
16 Chin holder for sinus image
17 Fibre optic cable
18 Mains cable for permanent connection
Product description
8 2210200378L02 1907V009
EN

3.1 Scope of delivery
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
VistaVox .. . . . . . . . . . . . . . . . . . . . . 2210200403
– VistaSoft imaging software DVD
– Fibre optic cable 10 m
– Exposure switch and holder
– Holder for bite block
– Bite blocks (3x)
– Chin holder for edentulous jaws
– Chin support for maxillary joint image
– Chin support for sinus image
– Head support with cushion
– Hygienic protective covers for bite block
– Test body holder (Germany, Switzerland and
Austria only)
– Top wall bracket set, short
– Small parts (e.g. screws, nuts etc.)
– Various housing parts
– Operating instructions
– Installation instructions
– X-ray log book (Germany, Switzerland and
Austria only)
– PCI Express frame grabber card
– USB dongle
– USB stick with unit-specific calibration data
If the mains cable of this unit is damaged
it must only be replaced by an original
mains cable from the manufacturer.
3.2 Optional items
The following optional items can be used with the
device:
Bottom wall bracket set, short
(wall/wall installation) .. . . . . . . . . . . 2210200553
Top wall bracket set, long .. . . . . . . 2210200611
Bottom wall bracket set, long (wall/
wall installation) .. . . . . . . . . . . . . . . 2210200439
Fibre optic cable 5 m .. . . . . . . . . . . 9000100494
Fibre optic cable 20 m .. . . . . . . . . . 9000100495
Acceptance and consistency check
Test body set for Pano .. . . . . . . . . 2121-060-55
Consistency check test body 3D
set .. . . . . . . . . . . . . . . . . . . . . . . . . 2210200527
Acceptance test body 3D .. . . . . . . 2210200526
Ball phantom .. . . . . . . . . . . . . . . . 2207-021-50
Primary absorber set Pano/Ceph .. . 2207100047
Test body holder for VistaPano S
(can be used with test body set for
Pano 2121-060-55 and with test
body 2121-060-54) .. . . . . . . . . . . . 2207-900-50
X-ray log book (Germany, Austria,
Switzerland, France) .. . . . . . . . . . 9000-618-245
Product description
2210200378L02 1907V009 9
EN

3.3 Consumables
The following materials are consumed during
operation of the device and must be ordered
separately:
Hygienic protective cover bite
block (100 pieces) .. . . . . . . . . . . . . 2207-010-50
Silicone pads for head support Plus ..2210200701
Cleaning and disinfection
FD 350 Classic
disinfection wipes .. . . . . . . . . . . CDF35CA0140
FD 333
rapid surface disinfection .. . . . . . CDF333C6150
FD 322
rapid surface disinfection .. . . . . . CDF322C6150
ID 215 Enzymatic instrument
cleaner .. . . . . . . . . . . . . . . . . . . . CDI220C6150
ID 212
Instrument disinfection .. . . . . . . . CDI212C6150
FD 366 rapid disinfectant for
sensitive surfaces .. . . . . . . . . . . . CDF366C6150
Information about replacement parts is
available from the portal for authorised
specialist dealers at:
www.duerrdental.net.
Product description
10 2210200378L02 1907V009
EN

4 Technical data
Electrical data for the unit
Rated voltage V AC 200 - 240
Frequency Hz 50/60
Protection class I
Operating mode X-ray tube S6 = 6.3% 320 s duty cycle
20 s / 5 min (switch-on/switch-off time)
Operating mode height adjustment S3 = 9% duty cycle
1 min / 9 min (switch-on/switch-off time)
Rated power W 170
Maximum power kVA 2.2
Fuses* T 10.0 AH / 250 V~ (IEC 60127-2, Sheet
5)
* The fuses must only be replaced by Dürr Dental or or by a company authorised by Dürr Dental.
Classification
Medical product class IIb
General technical data
Dimensions (W x D) mm
in
572.5 x 1181 ± 12
22.54 x 46.50 ± 0.47
Height mm
in
1406 - 2206
55.35 x 86.85
Weight kg
lbs
180
397
Ambient conditions during storage and transport
Temperature °C
°F
-10 to +60
14 to 140
Relative humidity % 10 - 75
Air pressure hPa 860 - 1060
Ambient conditions during operation
Temperature °C
°F
10 - 35
50 - 95
Relative humidity % 30 - 75
Air pressure hPa 860 - 1060
X-ray emitter
Model DG-07C11T2
Rated power kW 1.6 (for 1 s)
Type: high-voltage generator Inverter
Rated voltage, high-voltage generator kV 50 - 99 (±10 %)
Product description
2210200378L02 1907V009 11
EN

X-ray emitter
Nominal current, high-voltage generator mA 4 - 16 (± 10%, max. 75 kV 16 mA,
max. 99 kV 10 mA)
Cooling, high-voltage generator Automatic monitoring
Shut-off at ≥ 60°C
Additional filtering at 50 kV mm Al
in Al
2.0 + 3.0 (autom. added for CBCT)
0.08 + 0.12 (autom. added for CBCT)
Integrated filtering at 50 kV mm Al
in Al
0.8
0.03
Total filtering at 50 kV mm Al
in Al
2.8 + 3.0 (autom. added for CBCT)
0.11 + 0.12 (autom. added for CBCT)
X-ray tube model Toshiba D-052SB
Focal spot size as per IEC 60336 X-ray
tube
mm
in
0.5
0.02
Anode angle ° 5
Anode heat capacity kJ 35
Pulse/break ratio 1:60 or more
Duration of radiation exposure s 0.5 - 20
Maximum current-time product per hour mAs 960 (with 75 kV/16 mA)
4.1 X-ray tube performance data
– Maximum deviation of the peak voltage from the displayed value ± 10%
– Maximum deviation of the tube current from the displayed value ± 20%
– Maximum deviation of the exposure time from the displayed value ± 10%
– The unit complies with the standards IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-63.
– The lowest possible load factor is obtained with a combination of the settings 60 kV and 4 mA.
1235
5
710
10
20
25
15
20
EXPOSURE TIME [s]
Constant potential high-voltage generator
Nominal Focus Spot Value: 0.5
TUBE CURRENT [mA]
100kV
90kV
80kV 70kV 60kV
50kV
Maximum Rating Charts
DC (Center Grounded)
Product description
12 2210200378L02 1907V009
EN

1
2
3
4
5
6
5
10
20
25
15
0
2.9 3.0 3.1 3.2 3.3 3.4 3.5
Constant potential high-voltage generator
Nominal Focus Spot Value: 0.5
TUBE CURRENT [mA]
100kV
Ef
80kV
50kV
FILAMENT CURRENT [A]
FILAMENT VOLTAGE [V]
Emission and Filament Characteristics
0
0
5
10
20
30
15
25
35
246810
175 W
225 W
315 W
TIME (min)
COOLING
HEATING
HEAT STORAGE (kJ)
Anode Thermal Characteristics
Detector Pano/CBCT
Brand Xmaru 1404CF
Type CMOS photodiode array
Pixel size μm 49.5
99 (2x2 binning)
198 (4x4 binning)
in
0.001949
0.003898 (2x2 binning)
0.007795 (4x4 binning)
Sensor size mm
in
230 x 160 x 26
9.06 x 6.30 x 1.02
Active surface area mm
in
135.8 x 36.4
5.35 x 1.43
Product description
2210200378L02 1907V009 13
EN

Detector Pano/CBCT
Frame rate fps 53.5
107 (2x2 binning)
308 (4x4 binning)
Greyscale bit 14
Acquisition
mode
FDD
mm
in
FOD
mm
in
ODD
mm
in
Magnification factor
(magnification factor)
Panoramic 600
23.62
477.7
18.81
122.3
4.81 1.26
FDD: distance from focal spot to detector
FOD: distance from focal spot to object
ODD: distance from object to detector (ODD = FDD - FOD)
Magnification factor = FDD/FOD
Electromagnetic compatibility (EMC)
Interference emission measurements
High-frequency emissions in accordance with CISPR 11 Group 1
Interference voltage at the power supply connection
CISPR 11:2009+A1:2010
Class A
Electromagnetic interference radiation
CISPR 11:2009+A1:2010
Class A
Emission of harmonics
IEC 61000-3-2:2005+A1:2008+A2:2009
Class A
Voltage changes, voltage fluctuations and flicker emis-
sions
IEC 61000-3-3:2013
Compliant
Electromagnetic compatibility (EMC)
Interference immunity measurements cover
Immunity to interference, discharge of static electricity
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Compliant
Immunity to interference, high-frequency electromagnetic
fields
IEC 61000-4-3:2006+A1:2007+A2:2010
3 V/m
80 MHz - 2.7 GHz
80% AM at 1 kHz
Compliant
Immunity to interference, near fields of wireless HF com-
munication devices
IEC 61000-4-3:2006+A1:2007+A2:2010
See immunity to interference table, near fields of wireless
HF communication devices.
Compliant
Product description
14 2210200378L02 1907V009
EN

Immunity to interference table, near fields of wireless HF communication devices
Radio service Frequency band
MHz
Test level
V/m
TETRA 400 380 - 390 27
GMRS 460
FRS 460 430 - 470 28
LTE band 13, 17 704 - 787 9
GSM 800/900
TETRA 800
iDEN 820
CDMA 850
LTE band 5
800 - 960 28
GSM 1800
CDMA 1900
GSM 1900
DECT
LTE band 1, 3, 4, 25
UMTS
1700 - 1990 28
Bluetooth
WLAN 802.11 b/g/n
RFID 2450
LTE band 7
2400 - 2570 28
WLAN 802.11 a/n 5100 - 5800 9
Electromagnetic compatibility (EMC)
Interference immunity measurements supply input
Immunity to interference, rapid transient bursts – AC volt-
age grid
IEC 61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Compliant
Immunity to interference, line-line
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV
Compliant
Immunity to interference by surges, line-earth
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV, ± 2 kV
Compliant
Immunity to interference, line-conducted disturbances
induced by high-frequency fields – AC voltage grid
IEC 61000-4-6:2013
3 V
0.15 - 80 MHz
6 V
ISM frequency bands
0.15 - 80 MHz
80% AM at 1 kHz
Compliant
Product description
2210200378L02 1907V009 15
EN

Electromagnetic compatibility (EMC)
Interference immunity measurements supply input
Immunity to interference due to voltage dips, short inter-
ruptions and voltage variations
IEC 61000-4-11:2004
0% UTfor 0.5 period
0% UTfor 1 period
70% UTfor 25/30 periods (50/60 Hz)
0% UTfor 250/300 periods (50/60 Hz)
Compliant
Product description
16 2210200378L02 1907V009
EN

4.2 Dimensions
2206 mm
86,85 in
1406 mm
55,35 in
1963 mm
77,28 in
601 mm
23,66 in
2090 mm
82,28 in
345 ± 12 mm
13,58 ± 0,47 in
1181,4 ± 12mm
46,51 ± 0,47 in
1545 ± 12 mm
60,83 ± 0,47 in
1212 mm
47,72 in
572,5 mm
22,54 in
Product description
2210200378L02 1907V009 17
EN

4.3 Type plate
1
2
1 Unit type plate
2 X-ray tube type plate
4.4 Evaluation of conformity
This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant European Union guidelines. This
equipment conforms to all relevant requirements.
Product description
18 2210200378L02 1907V009
EN