Air Techniques ProVecta 3D Prime User manual

A7766
Manufactured in Germany for
ProVecta 3D Prime
Operating instructions
Notice d'utilisation
Instrucciones de uso
2210200496L41

1904V004
EN
US
FR
ES
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A7766
Manufactured in Germany for
ProVecta 3D Prime
Operating instructions
2210200496L41

1904V004
EN
US
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2210200496L41 1904V004 1
Usage
6 Operating the touch screen � � � � � � � � � 19
6�1 Navigating� � � � � � � � � � � � � � � � � � � 19
6�2 Using menus� � � � � � � � � � � � � � � � � 19
6�3 Calling up messages on the
touch screen� � � � � � � � � � � � � � � � � 19
7 Operation � � � � � � � � � � � � � � � � � � � � � � � 20
7�1 Switch the device on� � � � � � � � � � � 20
7�2 Making settings in the imaging
software � � � � � � � � � � � � � � � � � � � � 20
7�3 Inserting the positioning aids� � � � � 25
7�4 Positioning the patient� � � � � � � � � � 29
7�5 Start a test run � � � � � � � � � � � � � � � 32
7�6 Recording the X-ray image � � � � � � 33
7�7 Emergency stop switch� � � � � � � � � 34
8 Cleaning and disinfection� � � � � � � � � � � 36
8�1 Surface of the unit� � � � � � � � � � � � � 36
8�2 Positioning aids� � � � � � � � � � � � � � � 37
9 Reprocessing � � � � � � � � � � � � � � � � � � � � 38
9�1 Risk analysis and classification � � � 38
9�2 Reprocessing procedure in
accordance with EN ISO 17664 � � 38
9�3 General information� � � � � � � � � � � � 39
9�4 Preparation at the operating
location� � � � � � � � � � � � � � � � � � � � � 39
9�5 Manual cleaning, intermediate
rinsing, disinfection, final rinse,
drying � � � � � � � � � � � � � � � � � � � � � � 39
9�6 Automatic cleaning, intermediate
rinsing, disinfection, final rinse,
drying � � � � � � � � � � � � � � � � � � � � � � 40
9�7 Check for function� � � � � � � � � � � � � 40
9�8 Steam sterilization� � � � � � � � � � � � � 40
9�9 Issue clearance for the parts for
sterilization � � � � � � � � � � � � � � � � � � 41
9�10 Storing parts for sterilization � � � � � 41
10 Maintenance� � � � � � � � � � � � � � � � � � � � � 42
10�1 Recommended maintenance
schedule� � � � � � � � � � � � � � � � � � � � 42
EN
US
Contents
Important information
1 About this document � � � � � � � � � � � � � � � 3
1�1 Warnings and symbols � � � � � � � � � � 3
1�2 Copyright information � � � � � � � � � � � 4
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�1 Intended use and indication � � � � � � 4
2�2 Normal use � � � � � � � � � � � � � � � � � � � 4
2�3 Improper use � � � � � � � � � � � � � � � � � 4
2�4 Contraindication � � � � � � � � � � � � � � � 4
2�5 General safety information� � � � � � � � 5
2�6 Radiation protection � � � � � � � � � � � � 5
2�7 Specialist personnel � � � � � � � � � � � � 5
2�8 Protection from electric shock� � � � � 5
2�9 Essential performance
characteristics � � � � � � � � � � � � � � � � 6
2�10 Only use genuine parts � � � � � � � � � � 6
2�11 Transport � � � � � � � � � � � � � � � � � � � � 6
2�12 Disposal � � � � � � � � � � � � � � � � � � � � � 6
2�13 Protection from cybersecurity
threats � � � � � � � � � � � � � � � � � � � � � � 6
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � � � � 7
3�1 Scope of delivery � � � � � � � � � � � � � � 8
3�2 Accessories � � � � � � � � � � � � � � � � � � 8
3�3 Special accessories � � � � � � � � � � � � 8
3�4 Consumables � � � � � � � � � � � � � � � � � 8
4 Technical data � � � � � � � � � � � � � � � � � � � � 9
4�1 X-ray tube performance data� � � � � 10
4�2 Dimensions� � � � � � � � � � � � � � � � � � 14
4�3 Model identification plate� � � � � � � � 15
4�4 Conformity assessment� � � � � � � � � 15
5 Function � � � � � � � � � � � � � � � � � � � � � � � � 16
5�1 Functional description � � � � � � � � � � 16
5�2 Operating elements� � � � � � � � � � � � 16
5�3 Status LED � � � � � � � � � � � � � � � � � � 17
5�4 Positioning aids� � � � � � � � � � � � � � � 17
5�5 Exposure button � � � � � � � � � � � � � � 18
5�6 Memory card slot � � � � � � � � � � � � � 18
5�7 Sensor window� � � � � � � � � � � � � � � 18
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2 2210200496L41 1904V004
Contents
Troubleshooting
11 Tips for operators and service
technicians � � � � � � � � � � � � � � � � � � � � � � 43
Appendix
12 Program parameters � � � � � � � � � � � � � � 45
12�1 CBCT program parameters� � � � � � 45
12�2 Panoramic program parameters � � 45
13 Information on scattered radiation� � � � 46
13�1 CBCT scattered radiation � � � � � � � 46
13�2 Pano scattered radiation � � � � � � � � 46
14 Information on the leakage rate � � � � � � 47
EN
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2210200496L41 1904V004 3
Miscellaneous symbols
These symbols are used in the document and
on or in the unit:
Note, e�g� specific instructions regarding
the efficient use of the unit�
Part number
Serial number
CE labeling with the number of the noti-
fied body
Manufacturer
Caution: Federal law restricts this device
to sale by or on the order of a Doctor�
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE)�
Type BF applied part
Do not reuse
Not sterile
Sterilize with steam at 134 °C
Protective ground connection
Equipotential bonding
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
nStacking limits
Recycling
1 About this document
These installation and operating instructions are
an integral part of the unit�
Air Techniques shall not be held liable
and offers no guarantees of the safe and
smooth operation of this unit if you fail to
comply with notes and instructions con-
tained in these Installation and Operating
Instructions�
Refer to the separate installation instructions for
information about assembly, installation and
configuration of the unit�
1.1 Warnings and symbols
Warnings
The warning notes in this document highlight
possible injury to persons or damage to machin-
ery�
They are marked with the following warning
symbols:
General warning symbol
Warning – risk of dangerous electric volt-
ages
Warning – X-rays
The warnings are structured as follows:
Description of type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
iFollow these measures to avoid the
danger�
The signal word differentiates between different
levels of danger:
– DANGER
Direct 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
Important information
EN
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4 2210200496L41 1904V004
Important information
2 Safety
The unit has been developed and designed ap-
propriately such that hazards are largely exclud-
ed if the unit is used in accordance with its in-
tended use� Nevertheless, residual hazards may
remain�
Therefore, please note the following�
2.1 Intended use and indication
ProVecta 3D Prime is computed tomography x-
ray unit intended to generate 3D and panoramic
X-ray images in dental radiography for adult and
pediatric patients� It provides diagnostic details
of the maxillofacial areas for a dental treatment�
The device is operated and used by physicians,
dentists, and x-ray technicians�
Not intended for mammography use�
2.2 Normal 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 applica-
ble 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�
Keep dry
This way up / store and transport in an
upright position
Keep away from sunlight during storage
Comply with the Operating Instructions�
Wear hand protection�
Switch off and de-energize the device
(e�g� unplug the power cord)�
Notice
Emergency stop switch
Laser class 1
CAUTION
X-RAYAT TENTION: X-RAY
ONWHEN EQUIPMENT IN
OPERATION Warning – X-rays
Warning – risk of dangerous electric volt-
ages
Warning – X-rays
1.2 Copyright information
All electronic drawings, processes, names, soft-
ware, and appliances mentioned here are pro-
tected under copyright�
Printing or copying these Installation and Oper-
ating Instructions, including excerpts thereof,
may only be carried out with the written approv-
al of Air Techniques�
EN
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2210200496L41 1904V004 5
Important information
2.7 Specialist personnel
Operation
Persons operating the unit must ensure safe
and correct handling based on their training and
knowledge�
iInstruct or have every user instructed in han-
dling the unit�
Installation and repairs
iAll installation, resetting, alteration, expansion,
and repair work must be carried out either by
Air Techniques personnel or by a suitably
qualified person approved by Air Techniques�
2.8 Protection from electric shock
iComply with all relevant electrical safety regu-
lations when you work with this unit�
iNever touch the patient and unshielded plug
connections of the device at the same time�
iReplace any damaged cables or plugs imme-
diately�
Comply with the EMC rules concerning
medical devices
iThe appliance is designed for operation in
healthcare facilities (in accordance with IEC
60601-1-2)� If the appliance is operated in an-
other environment, observe possible effects
on the electromagnetic compatibility�
iDo not use the device near HF surgical devic-
es and MRI equipment�
iKeep a minimum distance of 30 cm between
the device and other electronical devices�
iNote that cable lengths and cable extensions
have effects on electromagnetic compatibility�
iNo maintenance measures are required to
maintain the basic EMC safety�
NOTICE
Negative effects on the EMC due to
non-authorized accessories
iOnly Air Techniques accessories or
accessories approved by Air Tech-
niques may be used�
iIf other accessories are used, observe
any negative consequences to the
function of the appliance�
2.5 General safety information
iComply with the guidelines, laws, rules and
regulations applicable at the site of operation
when you use this unit�
iPrior to each use, check the function and
proper condition of the device�
iDo not convert or modify the unit�
iComply with the Installation and Operating In-
structions�
iMake the Installation and Operating Instruc-
tions always available to the operator in the vi-
cinity of the device�
The sale or prescription of this device by a med-
ical practitioner is subject to the restrictions of
the applicable Federal Acts� The device may be
used only under permanent supervision by a
dentist or licensed medical practitioner�
Caution: Federal law restricts this device
to sale by or on the order of a Doctor�
2.6 Radiation protection
iComply with all applicable X-ray protection
regulations and X-ray protection measures�
iUse the prescribed X-ray protection equip-
ment�
iIn 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�
iThe persons operating the equipment must
keep away from the X-ray unit while the expo-
sure is being taken� The minimum distance re-
quired by the law must be maintained�
iChildren and pregnant women must consult a
doctor before recording an X-ray image�
iNo person other than the patient is permitted
to be present in the radiation room without X-
ray protection measures� In exceptional cir-
cumstances another person may be present
to provide assistance, but this must not be a
member of the surgery staff� When the expo-
sure is being taken, make sure that you main-
tain visual contact with the patient and the
unit and keep talking to the patient�
iThe radiation room must be lockable to pre-
vent entry by unauthorized persons�
iIf a fault occurs, abort the exposure immedi-
ately by releasing the trigger button�
EN
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6 2210200496L41 1904V004
Important information
2.11 Transport
Only the original packaging ensures optimum
protection for the unit during transport�
If necessary, the original packaging for this unit
can be ordered from Air Techniques�
Air Techniques cannot be held responsi-
ble for any damage resulting from trans-
port in unsuitable packaging, even during
the warranty period�
iOnly transport the unit in its original packag-
ing�
iKeep all packaging away from children�
iReattach the transport locking devices�
iDo not expose the unit to any strong vibra-
tions or shocks�
Do not bump or pull the unit�
2.12 Disposal
Device
The units and electronic circuits may be dis-
posed of only in proper facilities for recycling
and recovery� Make sure to dispose of these
objects in compliance with the applicable laws
and regulations of the federal, national, state
and municipal authorities�
X-ray emitter
The X-ray emitter contains a tube that is poten-
tially capable of imploding, lead cladding and
mineral oil�
2.13 Protection from cybersecurity
threats
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�
iUse antivirus software and update it regularly�
Look for evidence of possible virus infection
and, if applicable, check with the antivirus
software and remove the virus�
iPerform regular data backups�
iProvide access to units only to trustworthy us-
ers, e�g� by means of user name and pass-
word�
iMake sure that only trustworthy contents are
downloaded� Install manufacturer-authenticat-
ed software and firmware updates only�
NOTICE
Erroneous operation mode due to
use immediately adjacent to other
devices or with other stacked de-
vices
iDo not stack the unit together with
other devices�
iIf this is unavoidable, note any poten-
tial impacts on the operation mode�
NOTICE
Reduced performance features due
to insufficient distance between unit
and mobile HF communication de-
vices
iKeep at least 30 cm distance be-
tween the unit (including parts and
cables of the unit) and mobile HF
communication devices (wireless
units) (including their accessories
such as antenna cables and external
antennas)�
2.9 Essential performance charac-
teristics
The unit does not have any essential perfor-
mance characteristics as set out in IEC 60601-1
section 4�3�
The unit meets the requirements according to
IEC60601-1-2:2014�
2.10 Only use genuine parts
iOnly Air Techniques accessories and special
accessories or those approved by Air Tech-
niques may be used�
iOnly use original spare and replacement
parts�
Air Techniques accepts no liability for
damage resulting from the use of non-
approved accessories, special accesso-
ries or any parts other than original spare
and wear parts�
The use of non-approved accessories,
special accessories or non-genuine
working parts / spare parts (e�g�mains
cable) can have a negative effect on the
electrical safety and EMC�
The following accessories may affect EMC:
– Mains cable (3�6m; orderno�: A7782)
– Exposure switch (orderno�: A7801)
EN
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2210200496L41 1904V004 7
3 Overview
1
6
7
9
8
10111214 13
2
16 15
4
5
3
1 3D and panoramic X-ray unit
2 Wall bracket
3 Frame grabber card
4 USB dongle
5 USB stick with device-specific calibration
data
6 Small parts set (e�g� screws, nuts)
7 Exposure switch (with holder)
8 Head supports with cushion
9 Hygienic protective covers for bite block
10 Bite block
11 Adapter for bite block
12 Chin holder for maxillary joint image
13 Chin holder for edentulous jaws
14 Chin holder for sinus image
15 Fiber optic cable
16 Mains cable for permanent connection
Product description
EN
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8 2210200496L41 1904V004
Product description
3.3 Special accessories
The following optional items can be used with
the device:
Bottom wall bracket set, 16 inch,
short (wall/wall installation) � � � � � � � � � � � A7754
Fiber optic cable 5m � � � � � � � � � � � � � � � A7757
Fiber optic cable 20m � � � � � � � � � � � � � � A7758
Acceptance and consistency check
Test body set for Pano � � � � � � � � � � � � � � A7556
Consistency check test body 3D set � � � � A7759
Acceptance test body 3D � � � � � � � � � � � � A7760
Ball phantom � � � � � � � � � � � � � � � � � � � � � A7330
3.4 Consumables
The following materials are consumed during
operation of the device and must be re-ordered:
Hygienic protective cover bite block
(100 pieces) � � � � � � � � � � � � � � � � � � � � � � A7395
Cleaning and disinfection
Monarch surface disinfection wipes
(hundred pcs� - 7" x 9")� � � � � � � � � � � � � � H6171
Monarch enzymatic cleaner
(84�5 oz� bottle)� � � � � � � � � � � � � � � � � � � � H6201
Information on replacement part is avail-
able at the portal for authorized specialist
dealers:
www�airtechniques�com�
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):
ProVecta 3D Prime � � � � � � � � � � � � � � � � � A7750
– Fiber optic cable 10m / 33ft
– Exposure switch and holder
– Adapter for bite block
– Bite block
– Chin holder for edentulous jaws
– Chin holder for maxillary joint image
– Chin holder for sinus image
– Head supports with cushion
– Wall bracket top (16 in)
– Hygienic protective covers for bite block (100
pieces)
– Small parts set (e�g� screws, nuts)
– Operating instructions
– Installation instructions
– PCI Express frame grabber card
– USB dongle
– USB stick containing device-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 Accessories
The following items are required for operation of
the device, depending on the application:
Hygienic protective cover bite block
(100 pieces) � � � � � � � � � � � � � � � � � � � � � � A7395
Positioning aids
Adapter for bite block � � � � � � � � � � � � � � � A7375
Bite block (3 pieces) � � � � � � � � � � � � � � � � A7395
Chin holder for edentulous jaws � � � � � � � A7390
Head supports Plus with cushion � � � � � � A7752
Cushion for head supports Plus � � � � � � � A7753
Chin holder for mandibular joint image� � � A7391
Chin holder for sinus image� � � � � � � � � � � A7392
EN
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2210200496L41 1904V004 9
Product description
4 Technical data
Electrical data for the device
Nominal 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 W170
Maximum power kVA 2�2
Fuses* (2 pcs�)
A
T 10�0 AH / 250 V~ (IEC 60127-2, Sheet
5)
* The fuses may only be replaced by Air Techniques or by a body authorized by Air Techniques�
Classification
Medical device of class
Medical Devices Directive 93/42/EEC IIb
FDA classification (CFR Title 21) II
General technical data
Dimensions (W x D) mm
in
990 x 1130
38�98 x 44�49
Height mm
in
1406 - 2206
55�35 x 86�85
Vertical radius mm
in
700
27�56
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
EN
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10 2210200496L41 1904V004
Product description
X-ray emitter
Model DG-07C11T2 (H)
Rated power kW 1�6 (for 1s)
Type of high-voltage generator Inverter
Nominal voltage, high-voltage generator kV 50 - 99 (±10 %)
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 filtration at 50 kV mmAl
inAl
2�0 + 3�0 (autom� added for CBCT)
0�08 + 0�12 (autom� added for CBCT)
Integrated filtration at 50 kV mmAl
inAl
0�8
0�03
Total filtration 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 s0�5 - 20
Maximum current-time product per hour mAs 960 (at 75kV/16mA)
4.1 X-ray tube performance data
– Maximum deviation of the voltage peak 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 device complies with the standards IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-63�
– The lowest possible stress factor is obtained with a combination of the settings 60kV and 4mA�
1235
5710
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
50k
V
Maximum Rating Charts
DC (Center Grounded)
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2210200496L41 1904V004 11
Product description
1
2
3
4
5
6
5
10
20
25
15
02.93.0 3.13.2 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
2468
10
175 W
225 W
315 W
TIME (min)
COOLING
HEATING
HEAT STORAGE (kJ)
Anode Thermal Characteristics
Detector Pano/CBCT
Brand Xmaru1404CF
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
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12 2210200496L41 1904V004
Product description
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
Image capture scale
(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)
Image capture scale = FDD/FOD
Electromagnetic compatibility (EMC)
Interference emission measurements
High-frequency emissions in accordance with CISPR11 Group 1
Class A
Interference voltage at the power supply connection
CISPR11:2009+A1:2010 Conforms
Electromagnetic interference radiation
CISPR11:2009+A1:2010 Conforms
Emission of harmonics
IEC61000-3-2:2005+A1:2008+A2:2009 Conforms
Voltage changes, voltage fluctuations, and emission of
flicker
IEC61000-3-3:2013 Conforms
Electromagnetic compatibility (EMC)
Interference immunity measurements on cover
Immunity to interference by discharge of static electricity
IEC61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conforms
Immunity to interference by high-frequency electromag-
netic fields
IEC61000-4-3:2006+A1:2007+A2:2010
3 V/m
80 MHz - 2�7 GHz
80 % AM at 1 kHz
Conforms
Immunity to interference by near fields of wireless HF
communication devices
IEC61000-4-3:2006+A1:2007+A2:2010
See Table on immunity to interference table by near
fields of wireless HF communication devices�
Conforms
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2210200496L41 1904V004 13
Product description
Immunity to interference levels by 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 bands 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 on supply input
Immunity to interference by rapid transient bursts – AC
voltage grid
IEC61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Conforms
Immunity to interference, line-line
IEC61000-4-5:2005
± 0�5 kV, ± 1 kV
Conforms
Immunity to interference by surges, line-earth
IEC61000-4-5:2005
± 0�5 kV, ± 1 kV ± 2 kV
Conforms
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
Conforms
Immunity to interference due to voltage dips, short inter-
ruptions and voltage fluctuations
IEC61000-4-11:2004
Conforms
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14 2210200496L41 1904V004
Product description
4.2 Dimensions
2206 mm
86,85 in
1406 mm
55,35 in
1962 mm
77,24 in
598 mm
23,54 in
2090 mm
82,28 in
345 ± 12 mm
13,58 ± 0,47 in
1181,45 mm
46,51 in
1545 ± 12 mm
60,83 ± 0,47 in
1212 mm
47,72 in
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2210200496L41 1904V004 15
Product description
4.3 Model identification plate
1
2
1 Type plate for the complete system
2 X-ray tube type plate
4.4 Conformity assessment
This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant guidelines of the European Union�
This equipment conforms to all relevant require-
ments�
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16 2210200496L41 1904V004
Product description
5.2 Operating elements
1
234
1 Touch screen
2 Button for opening/closing the head sup-
ports
3 Button for positioning beams on/off
4 Buttons for height adjustment
The touch screen can be used to operate the
unit� Information can be entered on the touch
screen with the tip of a finger�
Figure 1: Monitor, unit ready to acquire image
1 Logged-in patient
2 Selected X-ray image
3 Display of the X-ray parameters (duration,
DAP value, voltage and current)
4 Selected parameters
The Help button can be used to open a help
page for the respective page� The Messages
button can be used to call up current messag-
es�
5 Function
5
6
3
4
1
2
7
1 Emergency stop switch
2 On/off switch
3 X-ray tube
4 C-shaped elbow
5 Status LED
6 Operating elements
7 Memory card slot
5.1 Functional description
Similar to computer tomography or magnetic
resonance tomography, sectional images can
be generated with CBCT� With CBCT, an X-ray
tube and an imaging sensor opposite it rotate
around a seated or standing patient� The X-ray
tube rotates through 180°-540° and emits a
conical X-ray beam� The X-rays pass through
the region under investigation and are measured
for image generation by a detector as an attenu-
ated grey scale X-ray image� Here, a large series
of two-dimensional individual images is acquired
during the revolution of the X-ray tube� Using a
mathematical calculation on the rotating image
series via a reconstruction computer, a grey val-
ue coordinate image is generated in the three
spatial dimensions� This three-dimensional coor-
dinate model corresponds to a volume graphic
that is made up of individual voxels� This volume
can be used to generate sectional images (to-
mograms) in all spatial dimensions as well as 3D
views�
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