KaVo OP 3D Pro User manual

ORTHOPANTOMOGRAPH™ OP 3D Pro
User manual
ENGLISH
216364 rev. 6
0.805.5115

Contents
1 Disclaimer................................................................... 6
2 Introduction................................................................ 7
2.1 ORTHOPANTOMOGRAPH™ OP 3D Pro....................................................... 7
2.2 Intended use......................................................................................... 8
2.3 Indications for use (USA only)................................................................. 8
2.4 Intended user profile.............................................................................. 8
2.5 Associated documentation....................................................................... 8
2.6 References.............................................................................................8
2.7 Abbreviations used in this manual............................................................ 8
2.8 Signal words..........................................................................................9
2.9 Disposal................................................................................................ 9
2.10 Warnings and precautions......................................................................9
2.10.1 Warnings to be observed during use............................................ 9
2.10.2 Warnings for cross infection...................................................... 10
2.10.3 General warnings..................................................................... 11
3 Unit description.........................................................13
3.1 Main parts and controls.........................................................................13
3.2 Patient positioning lights........................................................................14
3.3 Patient positioning panel........................................................................16
3.4 Cephalometric unit patient positioning panel (optional).............................. 17
3.5 Accessories.......................................................................................... 18
3.6 Other detachable parts..........................................................................19
3.7 Emergency stop switch..........................................................................20
3.8 Patient contacting parts.........................................................................20
4 Imaging programs.................................................... 21
4.1 Panoramic programs............................................................................. 21
4.2 Sectional imaging................................................................................. 27
4.3 Panoramic Automatic Dose Control (ADC)................................................ 28
4.4 ORTHOfocus™.......................................................................................29
4.5 Multilayer selection............................................................................... 29
4.6 User configurable panoramic mA level..................................................... 30
4.7 User Configurable Default Program......................................................... 30
4.8 Cephalometric programs........................................................................ 30
4.9 3D programs, small panel......................................................................34
4.10 3D programs, medium panel............................................................... 35
4.11 Selecting resolution and FOV................................................................38
4.12 3D Automatic Dose Control (ADC).........................................................38
4.13 MAR, Metal Artifact Reduction...............................................................39
4.14 Exposure settings for 3D imaging......................................................... 40
5 Touch screen display.................................................42
5.1 Main control panel................................................................................ 42
5.2 Modality section....................................................................................42
5.3 Exposure indicators and settings............................................................ 43
5.4 Status section...................................................................................... 43
5.5 Other sections...................................................................................... 44
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6 Using the unit........................................................... 45
6.1 Attaching and removing the sensor.........................................................45
6.2 Preparing the system............................................................................ 46
6.3 Panoramic exposures.............................................................................47
6.3.1 Positioning devices.....................................................................47
6.3.2 General instructions................................................................... 48
6.3.3 Panoramic patient positioning......................................................49
6.3.4 TMJ patient positioning...............................................................53
6.3.5 Maxillary Sinus patient positioning............................................... 55
6.3.6 Taking a panoramic exposure...................................................... 56
6.4 Cephalometric exposures....................................................................... 57
6.4.1 General instructions................................................................... 58
6.4.2 Patient positioning..................................................................... 59
6.4.3 Taking a cephalometric exposure................................................. 63
6.5 3D exposures....................................................................................... 64
6.5.1 General instructions................................................................... 64
6.5.2 Patient positioning..................................................................... 65
6.5.3 Scout image..............................................................................69
6.5.4 3D image................................................................................. 71
6.6 Warnings and error messages................................................................ 73
6.6.1 Acknowledging errors................................................................. 73
6.6.2 Image transfer errors.................................................................73
7 Troubleshooting........................................................ 74
7.1 Patient positioning................................................................................ 75
7.2 Image appearance................................................................................ 77
7.3 Artefacts..............................................................................................78
7.4 Unit operation...................................................................................... 79
8 Maintenance..............................................................80
8.1 Maintenance procedure..........................................................................80
8.1.1 Annual maintenance...................................................................80
8.1.2 Calibration intervals................................................................... 80
8.2 Changing the fuses............................................................................... 80
8.3 Cleaning and decontaminating the unit....................................................80
9 Calibration and adjustment....................................... 83
9.1 Introduction......................................................................................... 83
9.2 Preparing for calibration........................................................................ 83
9.3 Panoramic calibration............................................................................ 83
9.3.1 Panoramic geometry calibration................................................... 84
9.3.2 Panoramic pixel calibration..........................................................84
9.3.3 Panoramic Quality Check (optional)..............................................85
9.4 3D calibration.......................................................................................86
9.4.1 3D geometry calibration............................................................. 86
9.4.2 3D pixel calibration.................................................................... 87
9.4.3 3D Quality Check program..........................................................88
9.5 Cephalometric calibration.......................................................................89
9.5.1 Ceph pixel calibration.................................................................89
9.5.2 Ceph Quality check program (Optional)........................................ 90
10 Technical data.........................................................92
10.1 Technical specifications........................................................................ 92
4ORTHOPANTOMOGRAPH™ OP 3D Pro

10.2 Unit dimensions................................................................................ 104
10.3 Symbols that may appear on the device or its parts.............................. 107
10.4 Labels on the unit............................................................................. 109
10.5 Electromagnetic Compatibility (EMC) tables.......................................... 109
10.6 X-ray tube assemblies....................................................................... 113
11 PC requirements....................................................115
11.1 Minimum PC requirements..................................................................115
11.2 The dental imaging software...............................................................116
ORTHOPANTOMOGRAPH™ OP 3D Pro 5

1 Disclaimer
1 Disclaimer
ORTHOPANTOMOGRAPH™ OP 3D Pro User manual, 216364 r6.
Copyright © 11-2020 by Instrumentarium Dental, PaloDEx Group Oy. All rights reserved.
ORTHOPANTOMOGRAPH™, CLINIVIEW™ and ORTHOfocus™ are either registered
trademarks or trademarks of Instrumentarium Dental, PaloDEx Group Oy in the United
States and/or other countries.
KaVo™ is either a registered trademark or a trademark of Kaltenbach & Voigt GmbH in
the United States and/or other countries.
All other trademarks are property of their respective owners.
Documentation, trademark and the software are copyrighted with all rights reserved.
Under the copyright laws the documentation may not be copied, photocopied,
reproduced, translated, or reduced to any electronic medium or machine readable form
in whole or part, without the prior written permission of Instrumentarium Dental.
The original language of this manual is English.
Instrumentarium Dental reserves the right to make changes in specification and features
shown herein, or discontinue the product described at any time without notice or
obligation. Contact your Instrumentarium Dental representative for the most current
information.
The manufacturer has no liability for consequential damage, personal injury, loss,
damage or expense directly or indirectly caused by the use of the product. No agent,
distributor or other party is authorized to give warranty or other liability on behalf of the
manufacturer with respect to its products.
Manufacturer:
Instrumentarium Dental, PaloDEx Group Oy
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. [phone]
www.kavokerrgroup.com
For service, contact your local distributor.
6ORTHOPANTOMOGRAPH™ OP 3D Pro

2 Introduction
2 Introduction
2.1 ORTHOPANTOMOGRAPH™ OP 3D Pro
The ORTHOPANTOMOGRAPH™ OP 3D Pro (hereafter called "unit") is a dental X-ray
system for producing high quality digital images of dentition, TM-joints and skull. In
order to take images with the unit you need a suitable PC hardware connected to the
unit and CLINIVIEW™ software (or suitable third party software via TWAIN driver) to
capture and manage images. The unit performs the following procedures:
Panoramic
● Standard panoramic
● Pediatric panoramic (reduced width and height)
● Wide arch panoramic
● Bitewing
● TMJ, posterior-anterior (PA) projection
● TMJ, lateral projection
● Maxillary sinus
● Ortho Zone enhanced panoramic
● Orthogonal panoramic
Cephalometric (optional)
● Cephalometric lateral projection
● Cephalometric pediatric lateral projection
● Cephalometric postero-anterior (PA) projection
● Reverse Towne projection
● Waters view
● Carpus program (optional) (Not available in USA and Canada)
Small panel 3D (optional) H x W
● 61 x 41 mm Field of View
● 61 x 78 mm Field of View
Medium panel 3D, H x W (optional)
● 50 x 50 mm Field of View
● 61 x 78 mm Field of View
● 78 x 78 mm Field of View
● 78 x 150 mm Field of View
● 130 x 150 mm Field of View (optional)
NOTICE!
The FOV heights are maximum values measured at the center of the FOV, the
measured heights at the edges of the FOV are smaller.
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2 Introduction
2.2 Intended use
The unit is intended for dental radiographic examination of teeth, jaw and TMJ areas
by producing conventional 2D x-ray images as well as x-ray projection images of an
examined volume for the reconstruction of a 3D view.
The unit is also intended for carpus imaging in assisting cephalometric analyses (Not in
USA).
2.3 Indications for use (USA only)
The ORTHOPANTOMOGRAPH OP300 panoramic, cephalometric and cone beam computed
tomography X-ray device is intended to image the head and neck areas for diagnostic
support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas,
and with the 13x15 cm Field of View (FOV) this additionally includes the ear, nose and
throat (ENT) regions. The X-ray device produces conventional 2D X-ray images and X-
ray projection images for the reconstruction of a 3D view. The device is operated and
used by qualified healthcare professionals.
CAUTION!
USA only: Federal law restricts this device to sale by or on the order of a dentist or
other qualified professional.
2.4 Intended user profile
Only for professionally qualified dental/medical personnel.
Typical user is a dental assistant with specific training for using dental X-ray devices.
2.5 Associated documentation
● OP 3D Pro User manual
● OP 3D Pro Installation manual
● CLINIVIEW software user manual
● CLINIVIEW software installation manual
● The user manual supplied with the 3D imaging software
● The installation manual supplied with the 3D imaging software
2.6 References
The following instructions are delivered with in the OP 3D Pro installation manual:
● Firmware update instructions
● Calibration instructions
● Cephalostat upgrade instructions
● Cephalostat side changing instructions
● 3D upgrade instructions are delivered with the 3D upgrade kit.
2.7 Abbreviations used in this manual
FOV = Field Of View. The cylindrical 3D volume that is reconstructed by the system.
ROI = Region Of Interest. The anatomical area or region of the patient that you are
interested to examine.
8ORTHOPANTOMOGRAPH™ OP 3D Pro

2 Introduction
FH = Frankfort-Horizontal
H = Horizontal
ADC = Automatic Dose Control
LDT = Low Dose Technology™
MAR = Metal Artifact Reduction
2.8 Signal words
The following signal words and labels are used in this document:
WARNING! Indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION! Indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.
NOTICE! Highlights suggestions which will result in enhanced installation,
reliability, or operation. Not used for safety related hazards.
2.9 Disposal
The device, its spare parts, its replacement parts and its accessories may include
parts that are made of or include materials that are non-environmentally friendly or
hazardous. These parts must be disposed of in accordance with all local, national and
international regulations regarding the disposal of non-environmentally friendly or
hazardous materials.
Unit has at least the following parts that should be regarded as non-environmental
friendly waste products:
● Tubehead (Pb, oil)
● Collimator (Pb)
● All electronic circuits, electronic boards inside
● Sensor covers (EMC painted)
2.10 Warnings and precautions
2.10.1 Warnings to be observed during use
● The unit may be dangerous to the user and the patient, if the safety regulations in
this manual are ignored, if the unit is not used in the way described in this manual
and/or if the user does not know how to use the unit.
● The unit must only be used to take the dental x-ray exposures described in this
manual. The unit must NOT be used to take any other x-ray exposures. It is not safe
to use the unit to take x-ray exposures, that it is not designed for.
● Only professionally qualified dental and/or medical personnel are allowed to operate
the unit and carry out any diagnoses based on output from the unit.
● Because the x-ray limitations and safety regulations change from time to time, it is
the responsibility of the user to make sure that all the valid safety regulations are
fulfilled.
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2 Introduction
● When taking an x-ray exposure of a patient with exceptional anatomy (typically very
tall or large) use the Test-mode (no x-rays) first to make sure that patient can be
positioned correctly to the unit and for checking that the unit doesn't hit the patient.
● Operator should maintain visible contact with the patient and technical factors. This
allows immediate termination of radiation by the release of the exposure button in the
event of a malfunction or disturbance.
● It is the responsibility of the doctor to decide whether x-ray exposure or any
additional exposures are justified and necessary.
● The minimum height of patient that can be x-rayed in standing position is 120cm
(3.9ft/47.2in). The maximum height of patient in standing position is 200cm
(6.5ft/78in) in all other programs, except in 130 x150 mm 3D program, where it is
193cm (6.3ft/76in). Taller patients must be seated during imaging. These heights only
apply to patients with normal anatomy.
● Unit can collide with the legs of a seated patient when driving the carriage
downwards. Pay attention on the unit movement.
● Always use the lowest suitable x-ray dose to obtain the desired level of image quality.
● Avoid taking x-ray exposures of pregnant women.
● When taking an x-ray exposure of a child always use the lowest possible x-ray dose,
the smallest possible image area and the lowest possible resolution that allows you to
perform the required diagnostic task.
● If the patient is using a pacemaker, consult the manufacturer of the pacemaker before
taking an exposure to confirm that the x-ray unit will not interfere with the operation
of the pacemaker.
● Decontaminate all the surfaces that the patient is in contact with after every patient
to prevent cross infection.
● Decontaminate all device accessories that contact the patient during a radiographic
examination.
● Check that the power supply cable is properly attached to the mains socket and
visually check the cable for damage. If the cable is damaged, it shall be replaced by
authorized service technician only.
● Do not open or remove any of the unit’s enclosures. No user serviceable parts inside.
● Do not touch the patient and any exposed electrical connector, such as sensor
connector or Ethernet port, simultaneously.
● The customer must ensure that the siting environment fulfills the requirements listed
in the Installation manual. Special attention must be paid to the strength of the floor
and wall materials, electrical mains and radiation protection. It is the responsibility of
the customer to ensure that the site is large enough for the patients.
● The unit contains toxic materials that need to be handled properly when disposing the
unit. Return the unit to the dealer in the end of its life cycle.
● Excessive dust should be cleaned from the unit for free airflow and cooling. Switch of
the unit before cleaning.
● Always follow the instructions for patient positioning and imaging procedures
instructed in the User Manual.
● In case of water damage/water dropping over the product, call for service technician
to ensure the product is fully operational according to specification.
2.10.2 Warnings for cross infection
Always use available disposable protective covers with the patient positioning
accessories:
● Bite fork cover
● Chin support cover
● Head support cover
● Nose support cover
● Ear rod cover
10 ORTHOPANTOMOGRAPH™ OP 3D Pro

2 Introduction
2.10.3 General warnings
Personnel operating the device must be adequately trained with respect to the
technological principles of operation and radiation protection when using cone beam
computed tomography (CBCT) imaging.
This unit complies with the EMC (Electromagnetic Compatibility) according to IEC
60601-1-2. Radio transmitting equipment, cellular phones etc. shall not be used in close
proximity of the unit as they could influence the performance of the unit.
Always ensure to fulfill the requirements of the local and national regulations.
The correct software and settings in the workstation are essential to the performance of
the unit. Consult technical support to ensure correct setup.
WARNING! Explosion hazard - do not use in the presence of flammable
anesthetics, gases or vapors.
The unit is factory set to operate using a 230-240 ±10 VAC power supply. Never connect
the unit to a power supply different to the voltage marked on the unit.
If the unit needs to be connected to a multiple socket-outlet, the socket shall not be
placed on the floor.
To avoid the risk of electric shock, the unit must only be connected to a supply mains
with protective earth.
The site must fulfill the environmental requirements in the installation manual chapter
technical specifications.
There should be free space around the unit for safe operation.
The PC / Ethernet switch to which the unit is connected, should be approved
appropriately (e.g. EN 60950, IEC 60950, UL 60950). After installation, check that the
IEC 60601-1 leakage current levels are not exceeded.
This product itself complies with IEC 60601-1 medical safety standard but in order
to the system incorporating also a PC to comply the standard, EITHER the PC has to
be a medical PC OR the PC has to be located over 1,5 meters apart from the unit.
The installer and the user of the system shall confirm that at least one of the above
requirements is fulfilled. A PC is a medical one if it complies IEC 60601-1 standard and
that is indicated in the accompanying documents of the PC.
The unit shall be connected directly to the acquisition PC with an Ethernet cable.
Connection through the LAN-network of the site is not allowed. Two network ports are
needed in the PC in order to connect also to the site network.
All service operations must be made by authorized service personnel only.
The annual service as described in manual is mandatory for the correct and safe
operation of the unit.
When taking exposures, operators and service personnel must protect themselves from
radiation and remain at least two meters (six feet) away from the unit during exposure.
Protect the patient from scattered radiation by placing a protective lead apron over the
patient.
The unit must be installed and serviced according to the unit Installation & adjustments
manual by a qualified technician.
Only personnel trained and approved by the manufacturer of the unit are allowed to
service the unit.
3D imaging should not be used for routine or screening examinations in which
a radiograph is taken regardless of the presence or absence of clinical signs and
symptoms. 3D imaging examinations must be justified for each patient to demonstrate
that the benefits outweigh the risks.
ORTHOPANTOMOGRAPH™ OP 3D Pro 11

2 Introduction
Where it is likely that evaluation of soft tissues will be required as part of the patient’s
radiological assessment, the imaging should be done using conventional medical CT or
MR, rather than 3D imaging using Cone Beam technology.
Cone beam computed tomography images are not adequate for the analysis of soft
tissue.
Panoramic and 3D exposures should not be used if conventional intraoral radiographic
images (like bitewing exposures) would be sufficient.
Make sure that patient’s thyroid glands are protected by a lead apron during the
exposure.
The place where the unit is to be installed and the position from where the user will take
exposures must be correctly shielded from the radiation that is generated when the unit
is operated. Ensure to fulfill or exceed the requirements of your local regulations.
The unit or its parts must not be changed or modified in any way without approval and
instructions from the manufacturer.
When servicing use only approved replacement parts supplied by the manufacturer.
The use of accessories not complying with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of the resulting system.
If this device is used with 3rd party imaging application software not supplied by the
manufacturer, the 3rd party imaging application software must comply with all local laws
on patient information software. This includes the Medical Device Directive 93/42/EEC
and/or relevant legal requirements in the USA.
Do not connect any equipment to the unit that has not been supplied with the unit or
that is not recommended by the manufacturer. The use of accessory equipment not
complying with the equivalent safety requirements of this equipment may lead to a
reduced level of safety of the resulting system.
All protective covers must be properly installed before handing unit to the user or when
operating the unit.
The user must always ensure, especially after a system crash or break in the x-ray unit
- PC connection, or when scanning 2D images without patient ID, that images retrieved
from the unit are associated to the correct patient.
Correct sharp layer should be chosen when using multilayer PAN images. See user
manual chapter Multilayer PAN images for correct procedure.
12 ORTHOPANTOMOGRAPH™ OP 3D Pro

3 Unit description
3 Unit description
3.1 Main parts and controls
1. Column
2. Carriage
3. Main support
4. Rotating unit
5. On/off switch (rear of
carriage) and main fuses
6. Tubehead assembly
7. Touch screen display
8. Patient positioning panel
9. Sensor head
10. Head support
11. Chin rest
12. Handles
13. Cephalostat unit
14. Cephalostat sensor
15. Secondary collimator
16. Positioning panel
On/Off switch (used to power the unit on and off) and the main fuses.
PC with MDD approved dental imaging software and 3D viewing software (not included).
All software must conform to the MDD and the relevant legal requirements in the USA.
The PC must conform to all the unit and dental imaging software requirements.
ORTHOPANTOMOGRAPH™ OP 3D Pro 13

3 Unit description
1. Panoramic sensor
2. Sensor holder (panoramic units without
3D option)
1. 3D sensor (units with 3D option)
2. Panoramic sensor
3.2 Patient positioning lights
1. Midsagittal light
2. Frankfort horizontal (FH) light / Horizontal light, top of 130 mm high FOV
3. Image layer light
4. Cephalometric FH light
5. TMJ light
6. Horizontal light, top of 78 mm high FOV
7. Horizontal light, top of 61 mm high FOV
8. Horizontal light, top of 50 mm FOV
9. Horizontal light, bottom of FOV
14 ORTHOPANTOMOGRAPH™ OP 3D Pro

3 Unit description
Panoramic lights
1. Midsagittal light
2. FH light
1. Image layer light
2. TMJ light
Cephalometric lights (optional)
1. FH light
ORTHOPANTOMOGRAPH™ OP 3D Pro 15

3 Unit description
3D lights (optional)
NOTICE! Appropriate lights are turned automatically on based on selected FOV.
1. Midsagittal light
2. Horizontal light, top of FOV
NOTICE! With 3D medium panel option, Optional 130 mm height is indicated
with Frankfort horizontal (FH) light. Move FH light to 130 mm position (locked
in up-position).
3. Horizontal light, bottom of FOV
3.3 Patient positioning panel
1. Carriage UP
2. Carriage DOWN
3. Positioning lights ON/OFF
4. Patient positioning
5. Start positioning
6. Chin support UP
7. Chin support DOWN
8. Move the image layer anterior before exposure 3 mm, with sinus program 10 mm
9. Normal occlusion/ reset position
10. Move the image layer posterior before exposure 3 mm, with sinus program 10 mm
16 ORTHOPANTOMOGRAPH™ OP 3D Pro

3 Unit description
3.4 Cephalometric unit patient positioning panel
(optional)
1. Carriage UP
2. Carriage DOWN
3. Positioning lights ON/OFF
ORTHOPANTOMOGRAPH™ OP 3D Pro 17

3 Unit description
3.5 Accessories
Bite fork with the bite block Bite fork with the
edentulous bite positioner
Chin support for edentulous
patients
Sinus rest Chin rest TMJ nose support
Lower head support for FOV
130 x 150 mm imaging
Disposable covers for patient positioning devices
● Bite block disposable covers
● Chin support disposable covers
● Temple support disposable covers
● Nasion support disposable covers
● Ear rod disposable covers
18 ORTHOPANTOMOGRAPH™ OP 3D Pro

3 Unit description
3.6 Other detachable parts
Bubble level assembly 3D calibration phantom
QC phantom Cone phantom (for panoramic geometry
calibration)
Panoramic quality check tool (option) Panoramic quality check tool adapter for
ceph (option)
Sensor (Pan and Ceph) Temple support assembly
Lasers alignment tool Platform for dental model
ORTHOPANTOMOGRAPH™ OP 3D Pro 19

3 Unit description
3.7 Emergency stop switch
In case of malfunction of the exposure button or other protective devices of the unit, an
emergency stop switches are located near the handles and on the cephalostat unit, so
that the patient can easily reach them.
If the emergency stop switch is pressed during an exposure, the exposure is terminated
immediately and the x-ray unit is completely stopped. An interrupted exposure cannot
be continued later, but has to be retaken from the beginning after the emergency stop
switch is released.
Press to stop the unit, rotate to release.
3.8 Patient contacting parts
Applied parts/parts in
contact with patient
Part type Type of contact Contact
duration
Chin support Skin <5 min
Disposable cover
for chin support
Skin <5 min
Bite block Mucosal membrane <5 min
Disposable cover
for bite block
Mucosal membrane <5 min
Handle Skin <5 min
Ear rod Skin <5 min
Disposable cover
for ear rod
Skin <5 min
Sinus/Chin rest Skin <5 min
Nose support Skin <5 min
Disposable cover
for Nose support
Skin <5 min
Temple support Skin <5 min
Disposable cover
for Temple support
Skin <5 min
20 ORTHOPANTOMOGRAPH™ OP 3D Pro