KaVo ProXam iP User manual

KaVo ProXam iP
Instructions for use
EN

The manufacturer, assembler and importer are responsible for the safety, reliability and
performance of the unit only if:
- installation, calibration, modification and repairs are carried out by qualified
authorised personnel
- electrical installations are carried out according to the appropriate requirements such
as IEC 60364
- equipment is used according to the operating instructions.
Planmeca pursues a policy of continual product development. Although every effort
is made to produce up-to-date product documentation this publication should not be
regarded as an infallible guide to current specifications. We reserve the right to make
changes without prior notice.
COPYRIGHT PLANMECA
Publication number 1.015.1209 Revision 1
Released 1 March 2023

Table of contents
1 Important information..................................................................................................................................1
1.1 About this document.......................................................................................................................1
1.1.1 Warnings, cautions and notes........................................................................................1
1.1.2 Other symbols................................................................................................................1
1.1.3 Copyright information.....................................................................................................3
1.2 Safety............................................................................................................................................. 3
1.2.1 Intended purpose........................................................................................................... 3
1.2.2 Intended use.................................................................................................................. 4
1.2.3 Improper use..................................................................................................................4
1.2.4 General safety information.............................................................................................4
1.2.5 Qualified personnel........................................................................................................ 5
1.2.6 Electrical safety..............................................................................................................5
1.2.7 Essential performance characteristics........................................................................... 6
1.2.8 Notification requirement of serious incidents................................................................. 6
1.2.9 Only use original parts................................................................................................... 6
1.2.10 Transport........................................................................................................................6
1.2.11 Disposal......................................................................................................................... 6
1.2.12 Protection from threats from the Internet....................................................................... 7
2 Product description.....................................................................................................................................8
2.1 Overview.........................................................................................................................................8
2.1.1 Scope of delivery............................................................................................................8
2.1.2 Accessories....................................................................................................................9
2.1.3 Optional articles............................................................................................................. 9
2.1.4 Consumables................................................................................................................. 9
2.1.5 Wear parts and replacement parts...............................................................................10
2.2 Technical data.............................................................................................................................. 10
2.2.1 Imaging plate scanner..................................................................................................10
2.2.2 Imaging plate................................................................................................................14
2.2.3 Light protection cover...................................................................................................14
2.2.4 Type plate.................................................................................................................... 15
2.2.5 Evaluation of conformity...............................................................................................15
2.2.6 Distributor and manufacturer........................................................................................15
2.3 Operation......................................................................................................................................16
2.3.1 Imaging plate scanner..................................................................................................16
2.3.2 Operating elements......................................................................................................19
2.3.3 Connections................................................................................................................. 20
2.3.4 Cartridges (S0-S2)....................................................................................................... 20
2.3.5 Imaging plate................................................................................................................21
2.4 Light protection cover................................................................................................................... 21
3 Assembly.................................................................................................................................................. 22
3.1 Requirements............................................................................................................................... 22
3.1.1 Installation/setup room.................................................................................................22
3.1.2 System requirements................................................................................................... 22
3.1.3 Monitor......................................................................................................................... 22
3.2 Installation.................................................................................................................................... 22
Instructions for use KaVo ProXam iP

3.2.1 Setting up unit.............................................................................................................. 22
3.2.2 Electrical connections.................................................................................................. 26
3.2.3 Network connections....................................................................................................28
3.3 Commissioning.............................................................................................................................30
3.3.1 Network configuration.................................................................................................. 30
3.3.2 Network protocols and ports........................................................................................ 30
3.3.3 Configuring unit in KaVo Device Tool for ProXam iP...................................................30
3.3.4 X-ray unit settings........................................................................................................ 31
3.3.5 Acceptance tests..........................................................................................................32
4 Usage....................................................................................................................................................... 34
4.1 Correct use of imaging plates.......................................................................................................34
4.2 Operation......................................................................................................................................36
4.2.1 Changing input unit cartridge....................................................................................... 36
4.2.2 Capturing X-ray images............................................................................................... 39
4.2.3 Scanning image data................................................................................................... 43
4.2.4 Erasing imaging plates.................................................................................................46
4.2.5 Switching off unit..........................................................................................................48
4.3 Cleaning and disinfection............................................................................................................. 48
4.3.1 Imaging plate scanner..................................................................................................49
4.3.2 Light protection cover...................................................................................................50
4.3.3 Imaging plate................................................................................................................50
4.3.4 Storage box with imaging plate storage tray................................................................50
4.4 Maintenance.................................................................................................................................51
4.4.1 Recommended maintenance schedule........................................................................51
5 Troubleshooting........................................................................................................................................52
5.1 Tips for operators and service technicians...................................................................................52
5.1.1 Poor X-ray image......................................................................................................... 52
5.1.2 Software errors.............................................................................................................58
5.1.3 Unit faults..................................................................................................................... 59
6 Terms and conditions of warranty.............................................................................................................61
Appendix A: Resolution data...............................................................................................................................62
A.1 Scanning times.............................................................................................................................62
A.2 File sizes (uncompressed)............................................................................................................62
A.3 Contact information...................................................................................................................... 62
A.4 Sample handover protocol template.............................................................................................63
Appendix B: Country representatives................................................................................................................. 64
Table of contents
KaVo ProXam iP Instructions for use

1 Important information
1.1 About this document
This Instructions for use represents a part of the unit.
If the instructions and information in this Instructions for use are not followed,
KaVo will not be able to offer any warranty or assume any liability for the
safe operation and the safe functioning of the unit.
NOTE
The English version of the Instructions for use is the original document. All
other languages are translations of the original instructions. This Instructions
for use applies to the following KaVo ProXam iP:
• Material number 2160400500
(This item number is not an orderable number. For the respective order
number, see KaVo sales catalogue).
1.1.1 Warnings, cautions and notes
The warnings, cautions and notes in this Instructions for use are structured
as follows:
SIGNAL WORD
Description of the type and source of danger
Here you will find the possible consequences of ignoring
the warning > Follow these measures to avoid the danger.
The signal word differentiates between the three levels of danger:
WARNING
Possible danger of severe injury or death.
CAUTION
Risk of minor injuries.
NOTE
Risk of extensive material/property damage.
1.1.2 Other symbols
The following symbols are used in the document and on or in the unit.
Order number
Serial number
Medical device
Lot / batch labelling
1 Important information
Instructions for use KaVo ProXam iP 1

CE labelling
CE labelling with code of the Notified Body
Manufacturer
Dispose of correctly in accordance with EU Directive 2012/19/EU (WEEE)
Electronic instructions for use
Instructions for use
Comply with the operating instructions
Wear protective gloves
Switch off and de-energise the unit (e.g. unplug from mains)
Do not reuse
Health Industry Bar Code (HIBC)
Direct current (DC)
Non-ionizing electromagnetic radiation
This way up / store and transport in an upright position
Keep dry
Stacking limits
1 Important information
2 KaVo ProXam iP Instructions for use

Fragile, handle with care
Keep away from sunlight
Lower and upper humidity limits
Lower and upper temperature limits
Lower and upper atmospheric pressure limits
1.1.3 Copyright information
All circuits, processes, names, software programs and units mentioned in
this document are protected by copyright.
The Instructions for use must not be copied or reprinted, neither in full nor in
part, without written authorisation from the manufacturer.
1.2 Safety
The manufacturer has designed and constructed this unit so that when used
properly and for the intended purpose it does not pose any danger to people
or property.
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.
1.2.1 Intended purpose
KaVo ProXam iP
The unit is intended exclusively for use in dental applications for the
scanning and processing of image data on an image plate.
1 Important information
Instructions for use KaVo ProXam iP 3

Light protection cover
The functions of the Light Protection Cover are:
• to protect the image plate from light and therefore against accidental
erasure
• to protect against cross-contamination
1.2.2 Intended use
KaVo ProXam iP
The unit may only be operated using accessories and optional articles
manufactured by or branded with Dürr Dental. The unit may only be cleaned
using the disinfectants and cleaning agents approved by and specified by
the manufacturer.
Light protection cover
The Light Protection Cover is a disposable item. The Light Protection Cover
is designed exclusively for use with image plate scanners manufactured by
or branded with Dürr Dental and image plates manufactured by or branded
with Dürr Dental.
1.2.3 Improper use
Any other usage or usage beyond this scope is deemed to be improper. The
manufacturer accepts no liability for damages resulting from improper usage.
The user bears the sole risk.
KaVo ProXam iP
This unit is not suitable for monitoring patients over longer periods of time.
This unit must not be operated in operating theatres or similar rooms, in
which dangers may arise from the combustion of flammable materials.
Light protection cover
Especially:
• The multiple use of this accessory and reprocessing contrary to the
instructions of the manufacturer.
The use of the accessory in combination with other than image plate
scanners manufactured by or branded with Dürr Dental and image plates
manufactured by or branded with Dürr Dental.
1.2.4 General safety information
Always comply with the specifications of all guidelines, laws, and other rules
and regulations 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 Instructions for use.
The Instructions for use must be accessible to all operators of the unit at all
times.
1 Important information
4 KaVo ProXam iP Instructions for use

1.2.5 Qualified personnel
Operation
Unit operating personnel must ensure safe and correct handling based on
their training and knowledge.
Instruct or have every user instructed in handling the unit.
Installation and repairs
Installation, readjustments, alterations, upgrades and repairs must be carried
out by KaVo or by qualified personnel specifically approved and authorised
by KaVo.
1.2.6 Electrical safety
• Comply with all the relevant electrical safety regulations when working
on the unit
• Never touch the patient and unshielded plug connections or metallic
parts of the device at the same time
• Replace any damaged cables or plugs immediately
Observe EMC rules concerning medical devices
• 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 electromagnetic compatibility must be
taken into account
• Do not operate the unit in the vicinity of HF surgical instruments or MRT
equipment
• Maintain a minimum distance of at least 30 cm between the unit and
other electronic devices
• Keep a minimum distance of 30 cm between the unit and mobile radio
devices
• Note that cable lengths and cable extensions have effects on
electromagnetic compatibility
• No maintenance measures are required to maintain the EMC basic
safety
NOTE
Negative effects on the EMC due to non-authorised accessories.
Use only KaVo parts or accessories specifically approved by the
manufacturer.
Using any other accessories may result in increased electromagnetic
interference emissions or the unit having reduced electromagnetic immunity,
leading to an erroneous operation mode.
NOTE
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 correctly.
1 Important information
Instructions for use KaVo ProXam iP 5

1.2.7 Essential performance characteristics
The KaVo ProXam iP unit does not possess any significant performance
characteristics as set out in IEC 60601-1 (EN 60601-1) section 4.3.
The unit complies with the requirements according to IEC 60601-1-2:2014.
1.2.8 Notification requirement of serious incidents
The operator/patient is required to report any serious incident that occurs
in connection with the device to the manufacturer and to the competent
authority of the Member State in which the operator and/or patient is
established/resident.
1.2.9 Only use original parts
Only use distributor's parts or accessories and optional articles specifically
approved by the manufacturer.
Only use only original wear parts and replacement parts.
Distributor accepts no liability for damages or injury resulting from the use
of non-approved accessories or optional accessories, or from the use of
non-original 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.
1.2.10 Transport
The original packaging provides optimum protection for the unit during
transport.
If required, original packaging for the unit can be ordered from KaVo.
KaVo will not accept any responsibility or liability for damage occurring
during 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.
Do not expose the unit to any strong vibrations or shocks.
1.2.11 Disposal
NOTE
For an overview of the waste codes for Dürr Dental products, go to the
Download section under 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).
If you have any questions about the correct disposal of parts, please contact
your dental trade supplier.
Imaging plate
The imaging plate contains barium compounds.
Dispose of the imaging plate properly in accordance with the locally
applicable regulations.
1 Important information
6 KaVo ProXam iP Instructions for use

In Europe, dispose of the imaging plate in accordance with waste code with
waste code 20 03 01 "Mixed municipal waste".
1.2.12 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 software 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
1 Important information
Instructions for use KaVo ProXam iP 7

2 Product description
2.1 Overview
iP_parts.eps
1Imaging plate scanner
2Cartridge for imaging plates (S0 up to S2)
3Imaging plate
4Light protection cover
5Imaging software USB stick
6Romexis software USB stick
7Network cable (3 m)
8Power supply unit with country-specific adapter
2.1.1 Scope of delivery
The following items are included in the scope of delivery (possible variations
due to country-specific requirements and/or import regulations):
• KaVo ProXam iP Imaging Plate Scanner
• 2x KaVo imaging plate Size 0
• 2x KaVo imaging plate Size 1
• 4x KaVo imaging plate Size 2
• 100x KaVo light protection covers Size 0
• 100x KaVo light protection covers Size 1
• 300x KaVo light protection covers Size 2
• Cartridge for imaging plate, Size 0
• Cartridge for imaging plate, Size 1
• Cartridge for imaging plate, Size 2
2 Product description
8 KaVo ProXam iP Instructions for use

• Imaging plate storage box
• Power supply
• Power cable
• LAN cable RJ45
2.1.2 Accessories
The following items are required for operation of the device, depending on
the application.
Imaging plates and light protection covers
• KaVo Imaging Plate and Light Protection Cover, Size 0 (Imaging plates 2
pcs, Light protection covers 1000 pcs)
• KaVo Imaging Plate and Light Protection Cover, Size 1 (Imaging plates 2
pcs, Light protection covers 1000 pcs)
• KaVo Imaging Plate and Light Protection Cover, Size 2 (Imaging plates 2
pcs, Light protection covers 1000 pcs)
Light protection covers
• KaVo Light Protection Cover, Size 0, 100 pcs
• KaVo Light Protection Cover, Size 1, 100 pcs
• KaVo Light Protection Cover, Size 2, 300 pcs
• KaVo Light Protection Cover, Size 2, 1000 pcs
2.1.3 Optional articles
The following optional articles can be used with the unit:
• Wall Mounting Plate for KaVo ProXam iP
• Imaging Plate Storage Box
• Quart Set for KaVo ProXam iS / ProXam iP
2.1.4 Consumables
The following materials are consumed during operation of the device and
must be reordered separately.
Cleaning and disinfection
• Imaging plate cleaning wipes (10 pcs.)
• FD 333 forte wipes for quick-acting disinfection
• FD 350 Classic disinfection wipes
• FD 333 rapid surface disinfection
• FD 322 rapid surface disinfection
• FD 366 rapid disinfectant for sensitive surfaces
• ID 213 instrument disinfection
• ID 212 instrument disinfection
• ID 212 forte instrument disinfection
2 Product description
Instructions for use KaVo ProXam iP 9

Light protection covers
For more information, see section "Accessories" on page 9.
2.1.5 Wear parts and replacement parts
Cartridges
• Cartridge for Imaging Plate Size 0
• Cartridge for Imaging Plate Size 1
• Cartridge for Imaging Plate Size 2
Imaging plates
For more information on the imaging plates, see section "Accessories" on
page 9.
2.2 Technical data
2.2.1 Imaging plate scanner
Electrical data for the unit
Rated voltage V DC 24
Max. current consumption A 0.5
Max. power consumption W < 12
Electrical data – power supply unit
Nominal input voltage V AC 100 - 240
Frequency Hz 50/60
Nominal output voltage V DC 24
Max. output current A 0.5
General technical data
Dimensions (W x H x D) mm 167 x 231 x 216
Weight kg approx. 4
Duty cycle % 100
Max. theoretical resolution Line pairs / mm (Lp/mm) approx. 16.7
Noise level during scanning dB(A) approx. 45
Network connection
LAN technology Ethernet
Standard IEEE 802.3u
Data rate Mbit/s 100
Connector RJ45
Type of connection Auto MDI-X
Cable type ≥ CAT5
2 Product description
10 KaVo ProXam iP Instructions for use

Ambient conditions during operation
Temperature °C +10 to +35
Relative humidity % 20 - 80
Air pressure hPa 750 - 1060
Height above sea level m < 2000
Ambient conditions during storage and transport
Temperature °C -18 to +60
Humidity % 10 - 95, non-condensing
Air pressure hPa 500 - 1060
Classification
Medical Devices Directive (93/42/EEC): Class I
Laser class (unit) in accordance with EN 60825-1:2014: 1
Laser source
Laser class 3B acc. to IEC 60825-1:2014
Wavelength nm 635
Power mW <10
Technical data of the RFID Module
Frequency MHz 13.56
Modulation ASK
Max. power mW 400
Electromagnetic compatibility (EMC) interference emission measurements
High-frequency emissions in accordance with
CISPR 11 Group 1
Group 1, Class B
Interference voltage at the power supply
connection CISPR 11:2009+A1:2010
Compliant
Electromagnetic interference radiation CISPR
11:2009+A1:2010
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
2 Product description
Instructions for use KaVo ProXam iP 11

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 communication devices
IEC 61000-4-3:2006+A1:2007+A2:2010
See immunity to interference table, near fields of
wireless HF communication devices
Compliant
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
2 Product description
12 KaVo ProXam iP Instructions for use

Electromagnetic compatibility (EMC) Interference immunity measurements
supply input
Immunity to interference, rapid transient bursts –
AC voltage grid
IEC 61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Compliant
Immunity to interference, surges
IEC 61000-4-5:2005
± 0.5 kV, ± 1 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
Immunity to interference due to voltage dips,
short interruptions and voltage variations
IEC 61000-4-11:2004
Compliant
Electromagnetic compatibility (EMC) Interference immunity measurements
SIP/SOP
Immunity to interference, discharge of static
electricity
IEC 61000-4-2:2008
± 8 kV contact
± 2kV, ± 4 kV, ± 8 kV, ± 15 kV air
Compliant
Immunity to interference, rapid transient bursts –
I/O, SIP/SOP ports
IEC 61000-4-4:2012
± 1 kV
100 kHz repetition frequency
Compliant
2 Product description
Instructions for use KaVo ProXam iP 13

Immunity to interference, line-conducted
disturbances induced by high-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
Compliant
2.2.2 Imaging plate
Classification
Medical Device Class (MDR) IIa
Ambient conditions during operation
Temperature °C 18 - 45
Relative humidity % < 80
Ambient conditions during storage and transport
Temperature °C < 45
Relative humidity % < 80
Dimensions of intraoral imaging plates
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm
2.2.3 Light protection cover
Classification
Medical Device Class (MDR) I
2 Product description
14 KaVo ProXam iP Instructions for use

2.2.4 Type plate
The type plate is located on the rear of the device.
Order number
Serial number
2.2.5 Evaluation of conformity
This device has been subjected to conformity acceptance testing in
accordance with the current relevant European Union guidelines. This
equipment conforms to all relevant requirements.
Dürr Dental hereby declares that the radio system type "KaVo ProXam iP"
conforms to directive 2014/53/EU.
The full text of the EU Declaration of Conformity is available at
www.duerrdental.com.
2.2.6 Distributor and manufacturer
Distributor
KaVo Dental GmbH, Bismarckring 39, 88400 Biberach, Germany
Phone [phone], Fax [phone] http://www.kavo.com
Manufacturer
DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Phone: [phone]
http://www.duerrdental.com
[email protected]
2 Product description
Instructions for use KaVo ProXam iP 15

2.3 Operation
2.3.1 Imaging plate scanner
1Input unit
2Cover (open)
3Operating elements
4Collection tray
The imaging plate scanner is used to read image data stored on an imaging
plate and to transfer the data to the imaging software (e.g. Romexis) on a
computer.
The transport mechanism guides the imaging plate through the device. The
imaging 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 imaging plate runs through the erasure unit. Image data
still held on the imaging plate is erased with the aid of bright light.
The imaging plate is then ejected for re-use.
2 Product description
16 KaVo ProXam iP Instructions for use