Air Techniques ScanX Swift 2.0 User manual

ScanX Swift 2.0
XPS07.1A...
EN-US Installation and Operating Instructions
2144100140L29 G8802 2310V007

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Unauthorized modification .. . . . . 4
2.2 Intended use (FDA) .. . . . . . . . . . 4
2.3 General safety information .. . . . . 4
2.4 Specialist personnel .. . . . . . . . . 5
2.5 Protection from electric shock .. . 5
2.6 FCC note .. . . . . . . . . . . . . . . . . 5
2.7 ISED Statement .. . . . . . . . . . . . . 6
2.8 Essential performance charac-
teristics .. . . . . . . . . . . . . . . . . . . 7
2.9 Notification requirement of seri-
ous incidents .. . . . . . . . . . . . . . . 7
2.10 Only use genuine parts .. . . . . . . 7
2.11 Transport .. . . . . . . . . . . . . . . . . . 7
2.12 Disposal .. . . . . . . . . . . . . . . . . . 7
2.13 Protection from cybersecurity
threats .. . . . . . . . . . . . . . . . . . . . 7
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Scope of delivery .. . . . . . . . . . . . 9
3.2 Accessories .. . . . . . . . . . . . . . . . 9
3.3 Optional items .. . . . . . . . . . . . . . 9
3.4 Consumables .. . . . . . . . . . . . . . 9
3.5 Wear parts and spare parts .. . . . 10
4Technical data .. . . . . . . . . . . . . . . . . . . 11
4.1 Phosphor storage plate scanner
(XPS07.1A...) .. . . . . . . . . . . . . . . 11
4.2 Phosphor storage plate .. . . . . . . 14
4.3 Barrier envelope .. . . . . . . . . . . . 15
4.4 Model identification plate .. . . . . . 16
4.5 Conformity assessment .. . . . . . . 16
4.6 Simplified declaration of con-
formity .. . . . . . . . . . . . . . . . . . . . 16
5 Function .. . . . . . . . . . . . . . . . . . . . . . . 16
5.1 Phophor storage plate scanner .. 16
5.2 Phosphor storage plate .. . . . . . . 17
5.3 Barrier envelope .. . . . . . . . . . . . 18
5.4 Dust cover .. . . . . . . . . . . . . . . . . 18
Installation
6 Requirements .. . . . . . . . . . . . . . . . . . . 19
6.1 Installation/setup room .. . . . . . . 19
6.2 System requirements .. . . . . . . . . 19
6.3 Monitor .. . . . . . . . . . . . . . . . . . . 19
7 Installation .. . . . . . . . . . . . . . . . . . . . . . 19
7.1 Setting up the unit .. . . . . . . . . . . 19
7.2 Electrical connection .. . . . . . . . . 20
7.3 Connecting the unit to the net-
work .. . . . . . . . . . . . . . . . . . . . . 21
8Commissioning and first start-up .. . . 23
8.1 Configuring the network .. . . . . . 23
8.2 Configuring the unit .. . . . . . . . . . 23
8.3 Security settings .. . . . . . . . . . . . 23
8.4 Testing the device .. . . . . . . . . . . 23
8.5 X-ray unit settings .. . . . . . . . . . . 25
8.6 Commissioning tests .. . . . . . . . . 25
Usage
9Correct use of phosphor storage
plates .. . . . . . . . . . . . . . . . . . . . . . . . . . 27
10 Operation .. . . . . . . . . . . . . . . . . . . . . . 28
10.1 Switch the device on .. . . . . . . . . 29
10.2 Replacing the plate guide .. . . . . 29
10.3 X-ray .. . . . . . . . . . . . . . . . . . . . . 30
10.4 Scanning the image data via a
computer .. . . . . . . . . . . . . . . . . . 32
10.5 Erasing the phosphor storage
plate .. . . . . . . . . . . . . . . . . . . . . 33
10.6 Switching the unit off .. . . . . . . . . 33
11 Cleaning and disinfection .. . . . . . . . . . 34
11.1 Phophor storage plate scanner .. 34
Contents
2144100140L29 G8802 2310V007 EN-US | 1

11.2 Barrier envelope .. . . . . . . . . . . . 35
11.3 Phosphor storage plate .. . . . . . . 35
11.4 Dust cover .. . . . . . . . . . . . . . . . . 35
12 Maintenance .. . . . . . . . . . . . . . . . . . . . 36
12.1 Recommended maintenance
schedule .. . . . . . . . . . . . . . . . . . 36
Troubleshooting
13 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 37
13.1 Poor X-ray image .. . . . . . . . . . . 37
13.2 Software error .. . . . . . . . . . . . . . 41
13.3 Fault on the unit .. . . . . . . . . . . . 42
13.4 Error messages on the display .. 45
Appendix
14 Scanning times .. . . . . . . . . . . . . . . . . . 48
15 File sizes (uncompressed) .. . . . . . . . . 49
16 Handover record .. . . . . . . . . . . . . . . . . 50
Contents
2 | EN-US 2144100140L29 G8802 2310V007

Important information
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.
The German version of the installation and oper-
ating instructions is the original manual. All other
languages are translations of the original manual.
These operating instructions apply to:
ScanX Swift 2.0, Article number: G8800
(2144100510 / XPS07.1A1)
1.1 Warnings and symbols
Warnings
The warning notes in this document highlight
possible injury to persons or damage to machi-
nery.
They are marked with the following warning sym-
bols:
General warning symbol
The warnings are structured as follows:
SIGNAL WORD
Description of 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 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
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
Medical device
Batch name
Health Industry Bar Code (HIBC)
Model number
CE mark
Manufacturer
Distributor
Date of manufacture
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Take note of the accompanying electronic
documents.
Refer to Operating Instructions.
Wear hand protection.
Disconnect all power from the unit.
Do not reuse
DC current
Important information
2144100140L29 G8802 2310V007 EN-US | 3

Non-ionizing electro-magnetic radiation
Warning – risk of dangerous electric vol-
tages
Warning - laser beams
This way up / store and transport in an
upright position
Keep dry
n
Stacking limits
xx %
xx %
Lower and upper humidity limits
XX
YY
Lower and upper temperature limits
XX
YY
Lower and upper atmospheric pressure
limits
Fragile, handle with care
Keep away from sunlight during storage
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 Operat-
ing Instructions, including excerpts thereof, may
only be carried out with the written approval of
Air Techniques.
2 Safety
The unit has been developed and designed
appropriately such that hazards are largely
excluded if the unit is used in accordance with its
Intended use.
Therefore, please note the following.
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 the
skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Unauthorized modification
Pursuant to Part 15.21 of the FCC rules, any
changes or modifications to this equipment not
expressly approved by the manufacturer may
cause, harmful interference and void the FCC
authorization to operate this equipment.
2.2 Intended use (FDA)
ScanX Swift 2.0 - XPS07.1A...
Indications for use
The ScanX Swift 2.0 is intended to be used for
scanning and processing digital images exposed
on Phosphor Storage Plates (PSPs) in dental
applications.
Barrier envelope
Disposable Barrier Envelopes are intended to be
used as a disposable barrier for Air Techniques
Phosphor Storage Plates. This device is non-
sterile and intended for single patient use only.
2.3 General safety information
The sale or prescription of this device by a
medical 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: By virtue of Federal Law, the
device may only be sold to dentists or
bought on behalf of a dentist.
Important information
4 | EN-US 2144100140L29 G8802 2310V007

❯Comply with the guidelines, laws, rules and
regulations applicable at the site of operation
when you use this unit.
❯Prior to each use, check the function and
proper condition of the device.
❯Do not convert or modify the unit.
❯Comply with the Installation and Operating
Instructions.
❯Make the Installation and Operating Instruc-
tions always available to the operator in the
vicinity of the device.
2.4 Specialist personnel
Operation
Persons operating the unit 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
❯All installation, resetting, alteration, expansion,
and repair work must be carried out either by
Air Techniques personnel or by a suitably quali-
fied person approved by Air Techniques.
2.5 Protection from electric
shock
❯Working on the unit, comply with all the rele-
vant electrical safety regulations.
❯Never touch the patient and unshielded plug
connections or metallic parts of the device at
the same time.
❯Immediately replace any damaged cables or
plugs.
Comply with the EMC rules concerning
medical devices
❯The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the unit is operated in any other
environment, potential effects on the electro-
magnetic compatibility must be taken into
account.
❯Do not use the device near HF surgical devices
and MRI equipment.
❯Keep a minimum distance of 30 cm between
the device and other electronical devices.
❯Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
❯No maintenance measures are required to
maintain the basic EMC safety.
NOTICE
Negative effects on the EMC due to
non-authorized accessories
❯Use only Air Techniques accessories or
accessories approved by Air
Techniques.
❯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 features due to
insufficient distance between unit and
mobile HF communication devices
❯Keep at least 30 cm distance between
the unit (including parts and cables of
the unit) and mobile HF communica-
tion devices (wireless units) (including
their accessories such as antenna
cables and external antennas).
2.6 FCC note
Note: This equipment has been tested and found
to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable
protection against harmful interference in a resi-
dential installation. This equipment generates,
uses and can radiate radio frequency energy
and, if not installed and used in accordance with
the instructions, may cause harmful interference
to radio communications. However, there is no
guarantee that interference will not occur in a
Important information
2144100140L29 G8802 2310V007 EN-US | 5

particular installation. If this equipment does
cause harmful interference to radio or television
reception, which can be determined by turning
the equipment off and on, the user is encouraged
to try to correct the interference by one or more
of the following measures:
❯Reorient or relocate the receiving antenna.
❯Increase the separation between the equip-
ment and receiver.
❯Connect the equipment into an outlet on a cir-
cuit different from that to which the receiver is
connected.
❯Consult the dealer or an experienced radio/TV
technician for help.
Module Compliance FCC
The device contains the RFID module with the
following ID:
– FCC ID: 2ATTE-2144100082
– IC ID: 25412-2144100082
This module has been tested and found to com-
ply with the following requirements for Modular
Approval.
– Part 15.225 - Operation within the band
13.110 - 14.010 MHz.
– Part 2.1046 - Measurements required: RF
power output
Antennas
This radio transmitter has been approved by the
FCC and ISED to operate with the antenna types
listed below with the maximum permissible gain
indicated.
Antenna types not included in this list, having a
gain greater than the maximum gain indicated for
that type, are strictly prohibited for use with this
device.
Radio Antenna
Type
Frequency
NFC Loop 13,56 MHz
RF exposure statement
1. This Transmitter must not be co-located or
operating in conjunction with any other
antenna or transmitter.
2. This equipment complies with FCC RF radia-
tion exposure limits set forth for an uncontrol-
led environment. This equipment should be
installed and operated with a minimum dis-
tance of 20 centimeters between the radiator
and your body.
2.7 ISED Statement
EN:
This device contains licence-exempt transmit-
ter(s)/receiver(s) that comply with Innovation, Sci-
ence and Economic Development Canada’s
licence-exempt RSS(s). Operation is subject to
the following two conditions:
– This device may not cause interference.
– This device must accept any interference,
including interference that may cause unde-
sired operation of the device.
FR:
L’émetteur/récepteur exempt de licence contenu
dans le présent appareil est conforme aux CNR
d’Innovation, Sciences et Développement écono-
mique Canada applicables aux appareils radio
exempts de licence. L’exploitation est autorisée
aux deux conditions suivantes :
– l'appareil ne doit pas produire de brouillage, et
– l'utilisateur de l'appareil doit accepter tout
brouillage radioélectrique subi, même si le
brouillage est susceptible d'en compromettre
le fonctionnement.
RF exposure statement
EN:
Caution: Exposure to Radio Frequency Radiation
1. To comply with the Canadian RF exposure
compliance requirements, this device and its
antenna must not be co-located or operating
in conjunction with any other antenna or
transmitter.
2. To comply with RSS 102 RF exposure com-
pliance requirements, a separation distance
of at least 20 cm must be maintained
between the antenna of this device and all
persons.
FR:
Attention: exposition au rayonnement radiofré-
quence
1. Pour se conformer aux exigences de confor-
mité RF canadienne l’exposition, cet appareil
et son antenne ne doivent pas être co-local-
isés ou fonctionnant en conjonction avec une
autre antenne ou transmetteur.
2. Pour se conformer aux exigences de confor-
mité CNR 102 RF exposition, une distance
de séparation d’au moins 20 cm doit être
maintenue entre l’antenne de cet appareil et
toutes les personnes.
Important information
6 | EN-US 2144100140L29 G8802 2310V007

2.8 Essential performance char-
acteristics
The ScanX Swift View 2.0 unit does not have any
essential performance characteristics as set out
in IEC 60601-1 (EN 60601-1) section 4.3.
The unit meets the requirements according to
IEC 60601-1.
The unit meets the requirements according to
IEC 60601-1-2:2014.
2.9 Notification requirement of
serious incidents
The operator/patient has to report any serious
incident related the product to the manufacturer
and the competent authority of the Member
State, in which the operator and/or patient is
established/resident.
2.10 Only use genuine parts
❯Only use accessories and optional items speci-
fied or approved by Air Techniques.
❯Only use original working parts and spare
parts.
Air Techniques accepts no liability for
damage resulting from the use of non-
approved accessories, optional items or
any parts other than original spare and
wear parts.
The use of non-approved accessories,
optional items or non-genuine wear
parts / replacement parts (e. g. mains
cable) can adversely affect the electrical
safety and EMC.
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.
❯Only transport the unit in its original packaging.
❯Keep all packaging away from children.
❯Do not expose the unit to any strong vibrations
or shocks.
2.12 Disposal
Disposal of the units, electronic circuitry and
PSPs must be accomplished only at the appro-
priate facilities for recovery and recycling. Make
sure to dispose of such items in accordance with
current federal, national, state and local govern-
ment rules and regulations.
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.
❯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.
❯Provide access to units only to trustworthy
users, e.g. by means of user name and pass-
word.
❯Make sure that only trustworthy contents are
downloaded. Install manufacturer-authenti-
cated software and firmware updates only.
Important information
2144100140L29 G8802 2310V007 EN-US | 7

Product description
3 Overview
back
IDX
2
*+E247G36120/$+01234567L*
a
1
3
4
5
2
6
1 ScanX Swift 2.0 PSP scanner
2 Plate guides (S0 and S2)
3 Phosphor storage plate IDX
4 Barrier envelope
5 Network cable (3 m)
6 Power supply unit with country-specific adapter
Product description
8 | EN-US 2144100140L29 G8802 2310V007

3.1 Scope of delivery
The following items are included in the scope of
delivery (possible variations may apply due to
country-specific requirements and/or import reg-
ulations):
ScanX Swift 2.0
Phosphor storage plate scanner .. . . . G8800A
– ScanX Swift 2.0 Basic unit
– Power supply
– Network cable (3 m)
– Cover of device ports
– Voucher for VisionX imaging software
– Plate guides:
– Size 0
– Size 2 (mounted to the device)
– Phosphor storage plates IDX:
– Size 0
– Size 2
– Barrier envelopes:
– Size 0
– Size 2
– Barrier films
– Phosphor storage plate cleaning wipes
– Dust cover
– Quick Start Instructions
3.2 Accessories
The following items are required for operation of
the device, depending on the application:
Phosphor storage plates (PSPs)
– Phosphor storage plate IDX Size 0
– Phosphor storage plate IDX Size 1
– Phosphor storage plate IDX Size 2
– Phosphor storage plate IDX Size 3
– Phosphor storage plate IDX Size 4
Barrier envelopes
– Barrrier Envelope S0
– Barrrier Envelope S1
– Barrrier Envelope S2
– Barrrier Envelope S3
– Barrrier Envelope S4
3.3 Optional items
The following optional items can be used with the
device:
Wall bracket .. . . . . . . . . . . . . . . . . . . . . . G8820
Network cable (5 m) .. . . . . . . . . . . . . . . . G8595
Plate guide storage rack .. . . . . . . . . . . . . G8819
Commissioning and intraoral constancy tests
2D X-ray test phantom .. . . . . . . . . . . . . . G8795
3.4 Consumables
The following materials are consumed during
operation of the device and must be re-ordered:
Cleaning and disinfection
PSP cleaning wipes (50 pieces) .. . . . . . . . B8910
Barrier envelopes
Patented, easy-to-open barrier enve-
lope, size 0 (100 pcs.) .. . . . . . . . . . . . . 73248-0
Patented, easy-to-open barrier enve-
lope, size 1 (100 pcs.) .. . . . . . . . . . . . . 73248-1
Patented, easy-to-open barrier enve-
lope, size 2 (300 pcs.) .. . . . . . . . . . . . . 73248-2
Patented, easy-to-open barrier enve-
lope, size 2 (1000 pcs.) .. . . . . . . . . . . 73248-2k
Patented, easy-to-open barrier enve-
lope, size 3 (100 pcs.) .. . . . . . . . . . . . . 73248-3
Patented, easy-to-open barrier enve-
lope, size 4 (50 pcs.) .. . . . . . . . . . . . . . 73248-4
Product description
2144100140L29 G8802 2310V007 EN-US | 9

3.5 Wear parts and spare parts
Phosphor storage plates (PSPs)
Phosphor Storage Plate Pack IDX,
Size #0
Phosphor Storage Plate IDX S0 (2 pcs.)
Barrier Envelope S0 (1000 pcs.) .. . . . . G8240-0
Phosphor Storage Plate Pack IDX,
Size #1
Phosphor Storage Plate IDX S1 (2 pcs.)
Barrier Envelope S1 (1000 pcs.) .. . . . . G8240-1
Phosphor Storage Plate Pack IDX,
Size #2
Phosphor Storage Plate IDX S2 (2 pcs.)
Barrier Envelope S2 (1000 pcs.) .. . . . . G8240-2
Pack of phosphor storage plates IDX,
Size #3
Phosphor storage plate IDX Size 3
(2 pieces)
Barrier envelope Size 3 (1000 pieces) .. G8240-3
Pack of phosphor storage plates IDX,
Size #4
Phosphor storage plate IDX Size 4
(2 pieces)
Barier envelope Size 4 (1000 pieces) .. . G8240-4
Plate guides
Plate guide S0 (1 piece) .. . . . . . . . . . . . . G8813
Plate guide S1 (1 piece) .. . . . . . . . . . . . . G8814
Plate guide S2 (1 piece) .. . . . . . . . . . . . . G8815
Plate guide S3 (1 piece) .. . . . . . . . . . . . . G8816
Plate guide S4 (1 piece) .. . . . . . . . . . . . . G8817
Product description
10 | EN-US 2144100140L29 G8802 2310V007

4 Technical data
4.1 Phosphor storage plate scanner (XPS07.1A...)
Electrical data of the device
Voltage V DC 24
Max. current consumption A 1.25
Output W < 30
Type of protection IP20
Electrical data of the power supply unit
Nominal input voltage V AC 100 - 240
Frequency Hz 50/60
Nominal output voltage V DC 24
Max. output current A 1.25
General technical data
Dimensions (W x H x D) mm 211 X 249 X 258
in 8.31 X 9.80 X 10.16
Weight kg approx. 5.1
lb approx. 11.24
Pixel size (selectable) μm 12.5 - 50
Max. theoretical resolution Line
pairs/mm
(Lp/mm)
approx. 40
Network connection
LAN technology Ethernet
Standard IEEE 802.3u/IEEE 802.3ab
Data Rate Mbit/s 100/1000
Connector RJ45
Type of connection Auto MDI-X
Type of cable ³CAT5e
Ambient conditions during operation
Temperature °C +10 to +35
°F +50 to +95
Relative humidity % 20 - 80
Air pressure hPa 750 - 1060
Elevation above sea level m < 2000
ft < 6562
Product description
2144100140L29 G8802 2310V007 EN-US | 11

Ambient conditions during storage and transport
Temperature °C -20 to + 60
°F -4 to +140
Relative humidity % 10 - 95
Air pressure hPa 750 - 1060
Classification
Medical Device Class (MDR) I
FDA classification (CFR Title 21) II
Laser class (unit)
in accordance with IEC 60825-1:2014
1
Laser source
Laser class
in accordance with IEC 60825-1:2014
3B
Wavelength lnm 639
Output mW <12
Technical data of the RFID module
Frequency MHz 13.56
Modulation ASK
Electromagnetic compatibility (EMC)
Interference emission measurements
High-frequency emissions in accordance with CISPR 11 Group 1
Class B
Interference voltage at the power supply connection
CISPR 11:2009+A1:2010 Conforms
Electromagnetic interference radiation
CISPR 11:2009+A1:2010 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
Product description
12 | EN-US 2144100140L29 G8802 2310V007

Electromagnetic compatibility (EMC)
Interference immunity measurements on cover
Immunity to interference by near fields of wireless HF
communication devices
IEC 61000-4-3:2006+A1:2007+A2:2010
See Table on immunity levels with respect to near fields of
wireless HF communication devices
Conforms
Immunity levels with respect to 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, surges
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV
Conforms
Product description
2144100140L29 G8802 2310V007 EN-US | 13

Electromagnetic compatibility (EMC)
Interference immunity measurements on supply input
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
Electromagnetic compatibility (EMC)
Interference immunity measurements SIP/SOP
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 electrical fast transients/bursts – I/O,
SIP/SOP ports
IEC 61000-4-4:2012
± 1 kV
100 kHz repetition frequency
Conforms
Immunity to conducted disturbances, induced by radio-
frequency fields – SIP/SOP ports
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
4.2 Phosphor storage plate
Classification
Medical Device Class (MDR) IIa
FDA classification (CFR Title 21) I
Ambient conditions during operation
Temperature °C 18 - 45
°F 64 - 113
Relative humidity % < 80
Product description
14 | EN-US 2144100140L29 G8802 2310V007

Ambient conditions during storage and transport
Temperature °C < 45
°F < 113
Relative humidity % < 80
Dimensions of phosphor storage plates
S0 mm 22 x 35
in 0.87 x 1.38
S1 mm 24 x 40
in 0.94 x 1.57
S2 mm 31 x 41
in 1.22 x 1.61
S3 mm 27 x 54
in 1.06 x 2.13
S4 mm 57 x 76
in 2.24 x 2.99
4.3 Barrier envelope
Classification
Medical Device Class (MDR) I
FDA classification (CFR Title 21) Class II
Product description
2144100140L29 G8802 2310V007 EN-US | 15

4.4 Model identification plate
The type plate is located on the back cover of
the device.
REF Order number
SN Serial number
4.5 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.
4.6 Simplified declaration of con-
formity
The manufacturer hereby declares that the
device satisfies the requirements of, among oth-
ers, Directive 2014/53/EU.
The full text of the EU declaration of conformity
can be viewed online in the Download Center:
https://qr.duerrdental.com/conformity
5 Function
5.1 Phophor storage plate scan-
ner
12
3
1 Plate guide
2 Control elements and display
3 Collection tray
The phosphor storage plate scanner is used to
scan image data stored on a phosphor storage
plate and transfer the data to the imaging soft-
ware (e.g. VisionX) on a computer.
The transport mechanism guides the phosphor
storage plate through the device. The phosphor
storage plate is read using a laser inside the
scanner unit. The scanned data is converted into
a digital image and transferred to the imaging
software.
After scanning, the phosphor storage plate runs
through the erasure unit. Image data still held on
the phosphor storage plate is erased with the aid
of bright light.
The phosphor storage plate is then ejected for
re-use.
Product description
16 | EN-US 2144100140L29 G8802 2310V007

Operating elements
132
1 On/off switch
2Confirmation key
3 Display
On/off switch
The On/Of button indicates different states of the
device:
Device off
Press the On/Off button to start the
device.
The device starts up or is ready for use
The start screen is displayed as soon
as the device is ready for use.
Confirmation key
The confirmation key is used to acknowledge
messages on the display. The key flashes when a
message is displayed that needs to be acknowl-
edged.
Display
The display shows information that is made avail-
able by the imaging software.
Connections
The connections are located on the rear of the
unit, underneath the cover.
1
2
3
4
1 USB port (additional accessories)
2 Network connection
3 Reset button
4 Connection for power supply unit
5.2 Phosphor storage plate
The PSP stores X-ray energy, which is re-emitted
in the form of light after excitation by the laser.
This light is then converted into image informa-
tion in the phosphor storage plate scanner.
The PSP has an active side and an inactive side.
The PSP must always be exposed on the active
side.
When used properly, a PSP can be exposed,
read and erased several hundred times provided
there is no mechanical damage. The PSP must
be replaced if there are any signs of damage, e.g.
if the protective layer is damaged or there are
visible scratches that could interfere with the
diagnostics.
Intraoral
Inactive side Active side
back
IDX
2
*+E247G36120/$+01234567L*
a
a
Product description
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Inactive side Active side
White, with "back",
size and manufactur-
er's information
printed on it
Light blue, with posi-
tioning aid a
Positioning aid ais visible on the x-ray image and
makes orientation easier during diagnosis.
Only use phosphor storage plate IDX with
the unit. The unit is unable to read any
other types of PSP.
5.3 Barrier envelope
Disposable Barrier Envelopes are intended to be
used as a disposable barrier for Air Techniques
Phosphor Storage Plates. This device is non-
sterile and intended for single patient use only.
5.4 Dust cover
The dust cover protects the device against dust
and dirt, for example during extended periods in
which the device is not in use.
Product description
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