ORTHOPANTOMOGRAPH®/ INSTRUMENTARIUM
DENTAL™/ CLINIVIEW™ is a registered trademark/ a
common law trademark of Instrumentarium Dental,
PaloDEx Group Oy.
U.S. patents US6731717, US6829326 and USRE41197.
Finnish patents 114383.
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.
ManufacturerInstrumentarium Dental, PaloDEx Group Oy
10 PC requirements ......................................................................................................121
10.1 Minimum PC requirements................................................................................ 121
10.2 The dental imaging software ............................................................................. 124
rev iii
iv rev
1Introduction
1.1ORTHOPANTOMOGRAPH® OP300
INSTRUMENTARIUM DENTAL™
ORTHOPANTOMOGRAPH® OP300 x-ray unit (hereafter
called “OP300”) is a dental x-ray system for producing high
quality digital images of dentition, TM-joints and skull. In
order to take images with OP300 you need a suitable PC
hardware connected to the OP300 unit and CLINIVIEW™
software (or suitable third party software via TWAIN driver)
to capture and manage images.
OP300 performs the following procedures:
Panoramic
•Standard panoramic
•Pediatric panoramic
•Wide arch panoramic
•Bitewing
•TMJ, PA projection
•Ortho TMJ, axial corrected 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)
210457 rev 7Instrumentarium Dental1
1 Introduction
3D SFOV (optional) H x W
•61x41 mm Field of View
•61x78 mm Field of View
3D MFOV (Maxio) (optional) H x W
•MFOV (Maxio) 50 x 50 mm Field of View
•MFOV (Maxio) 61 x 78 mm Field of View
•MFOV (Maxio) 78 x 78 mm Field of View
•MFOV (Maxio) 78 x 150 mm Field of View
•MFOV (Maxio) 130 x 150 mm Field of View
(optional)
1.2References
The following instructions are delivered with in the
OP300 installation manual:
•Firmware update instructions
•Calibration instructions
•Cephalostat upgrade instructions
•Cephalostat side changing instructions
The following instructions are separate and can be ordered
from customer service:
•3D upgrade instructions are delivered with the 3D
upgrade kit.
1.3Intended use
OP300 must only be used and operated by healthcare
professionals and other qualified professionals. OP300
must only be used to take panoramic, cephalometric and
3D images of the dento-maxillofacial complex of the
human skull. It must not be used to take images of any
other part of the human body.
Panoramic and 3D exposures should not be used if
conventional intraoral radiographic images (like bitewing
exposures) would be sufficient.
Cone beam computed tomography images are not
adequate for the analysis of soft tissue.
2Instrumentarium Dental210457 rev 7
CAUTION! USA only: Federal law restricts this device to
sale by or on the order of a dentist or other qualified
professional.
1.4Associated documentation
•OP300 user manual
•OP300 installation manual
•The CLINIVIEW™ software user manual
•The CLINIVIEW™ software installation manual
•The user manual supplied with the dental imaging
software
•The installation manual supplied with the dental
imaging software
•The user manual supplied with the 3D imaging
software
1 Introduction
•The installation manual supplied with the 3D
imaging software
1.5Abbreviations 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.
FH = Frankfort-Horizontal
H = Horizontal
1.6Warnings and precautions
1.6.1Warnings 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.
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1 Introduction
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.
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 technique 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 is 120
cm (3.9ft / 47.2in) and the maximum is 200 cm (6ft /78in).
These heights only apply to patients with normal anatomy.
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.
Do not open or remove any of the unit’s enclosures. No
user serviceable parts inside.
4Instrumentarium Dental210457 rev 7
1 Introduction
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.
1.6.2Warnings 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 holder cover
1.6.3General 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.
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1 Introduction
The correct software and settings in the workstation are
essential to the performance of the unit. Consult technical
support to ensure correct setup.
Danger: 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.
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.
To maintain patient safety it is mandatory to use an
unshielded CAT6 Ethernet cable between the unit and the
network or workstation, so that multiple chassis are not
connected. Non-medical grade PC should not be used in
patient environment.
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. See chapter
Technical specifications, Minimum PC Requirements, in
user manual.
The unit shall be connected directly to the acquisition PC
with an Ethernet cable. Connection through the LANnetwork 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.
6Instrumentarium Dental210457 rev 7
1 Introduction
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 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.
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.
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
210457 rev 7Instrumentarium Dental7
1 Introduction
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.
Correct sharp layer should be chosen when using
multilayer PAN images. See user manual chapter
Multilayer PAN images for correct procedure.
1.7Disclaimer
The manufacturer shall have no liability for consequential
damages, personal injury, loss, damage or expense
directly or indirectly arising from the use of its products. No
agent, distributor or other party is authorized to make any
warranty or other liability on behalf of the manufacturer with
respect to its products.
1.8Disposal
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:
5. On/off switch (rear of carriage)
and main fuses
6. Tubehead assembly
7. Touch screen display
8. 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
Fig 1.1. On/off switch and main fuses
2.1Main parts and controls
PC with MDD approved dental imaging software and 3D
viewing software (not included).
210457 rev 7Instrumentarium Dental9
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.
2 Unit description
1. Sensor holder (units without 3D option)
2. Panoramic sensor
1. 3D sensor (units with 3D option)
2. Panoramic sensor
10Instrumentarium Dental210457 rev 7
2.2Patient positioning lights
2 Unit description
1. Midsagittal light
2. Frankfort horizontal (FH) light /
Horizontal light, top of 130 mm high FOV (3D MFOV
(Maxio) option only)
3. Image layer light
4. Cephalometric FH light
5. TMJ light
6. Horizontal light, top of 78 mm high FOV
(3D MFOV (Maxio) option only)
7. Horizontal light, top of 61 mm high FOV
(3D option only)
8. Horizontal light, top of 50 mm FOV
(3D MFOV (Maxio) option only)
9. Horizontal light, bottom of FOV (3D option only)
210457 rev 7Instrumentarium Dental11
2 Unit description
Fig 1.1.
Fig 1.2.
Panoramic lights
1. Midsagittal light
2. FH light
1. Image layer light
2. TMJ light
12Instrumentarium Dental210457 rev 7
Cephalometric lights
Fig 1.3.
Fig 1.4.
1. FH light
2 Unit description
3D lights (optional)
Note! Appropriate lasers are turned automatically on
based on selected FOV.
1. Midsagittal light
2. Horizontal light, top of FOV
Note! With 3D MFOV (Maxio) option height 130 mm is
indicated with Frankfort horizontal (FH) light. Move FH
light to 130 mm position (locked in up-position).
3. Horizontal light, bottom of FOV
210457 rev 7Instrumentarium Dental13
2 Unit description
2.3Patient 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
2.3.1Cephalometric unit (optional)
1. Carriage UP
2. Carriage DOWN
3. Carriage UP
4. Carriage DOWN
5. Positioning lights ON/OFF
14Instrumentarium Dental210457 rev 7
2.4Emergency stop switch
Fig 1.6.
Fig 1.7.
In case of malfunction of the exposure button or other
protective devices of the unit, an emergency stop switch is
provided near the handles and on the roof of the
cephalostat head so that the patient can reach it.
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.
2 Unit description
Press to stop the unit, rotate to release.
210457 rev 7Instrumentarium Dental15
2 Unit description
16Instrumentarium Dental210457 rev 7
3Imaging programs
3.1Panoramic programs
Standard: Magnification 1.3
Exposure settings for panoramic program
100 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
230 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
< default >
Pediatric: Magnification 1.3
Exposure settings for pediatric program
100 VAC66 kV/4 mA66 kV/6.3 mA66 kV/8 mA70 kV/10 mA
230 VAC66 kV/4 mA66 kV/6.3 mA66 kV/8 mA70 kV/10 mA
< default >
210457 rev 7Instrumentarium Dental17
3 Imaging programs
Pediatric patients can be imaged with less radiation
dosage and shorter exposure time. Patients with jaw more
narrow than average jaw can be exposed with this
procedure too.
Ortho Zone: Magnification 1.25
The Ortho Zone program produces two different scanning
geometries combined in the same image.
The first geometry (#1 and #3 in the figure) gives a
standard panoramic view of the molar region.
The result of this scanning location will allow for views of
the TM joint and molar area without redundant shadows
from the opposite side ramus obscuring the image.
Patients with prosthetic condyles or other posterior radio
opaque objects can have the opposite side successfully
imaged.
The second view (#2 in the figure) produces an image of
the anterior region with a very wide layer of focus (approx.
35 mm). This view may be helpful when diagnosing
trauma, wired shut, severe class III malocclusion and
uncooperative patients.
Exposure settings for Ortho Zone program
100 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
230 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
< default >
18Instrumentarium Dental210457 rev 7
Orthogonal: Magnification 1.3
Y
An optimized view of the dentition only with
optimized angulation and reduced radiation.
Orthogonal program produces a panoramic view with
modified projection geometry. The Y axis of the rotation
path is changed to improved the beam angle to be closer to
90° to the interproximal surfaces. With this improvement,
other trade off's must be made. The ascending rami may
be lost and in adult patients and redundant shadows will be
increased.
Exposure settings for Orthogonal program
3 Imaging programs
100 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
230 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
< default >
Wide arch: Magnification 1.3
Used when the patient has a wider than normal
dental arch.
Exposure settings for Wide arch program
100 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
230 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
< default >
210457 rev 7Instrumentarium Dental19
3 Imaging programs
a
b
Ortho Lateral TMJ: Magnification 1.23
Ortho TMJ program provides a wide layer axially corrected
views for the patient's left and right temporomandibular
joints.
Exposure settings for Ortho Lateral TMJ program
100 VAC73 kV/6.3 mA73 kV/10 mA73 kV/13 mA73 kV/16 mA
230 VAC73 kV/6.3 mA73 kV/10 mA73 kV/13 mA73 kV/16 mA
< default >
PA TMJ: Magnification 1.55
Exposure settings for PA TMJ program
100 VAC73 kV/6.3 mA73 kV/10 mA73 kV/13 mA73 kV/16 mA
230 VAC73 kV/6.3 mA73 kV/10 mA73 kV/13 mA73 kV/16 mA
< default >
20Instrumentarium Dental210457 rev 7
3 Imaging programs
Maxillary Sinus: Magnification 1.3
Mesial 10 mm Start Distal 10 mm
Maxillary Sinus program produces a pan - tomographic
layer through the posterior maxillary sinus. The layer is
flatter than the standard panoramic programs and is
moved 18 mm backward. These images are helpful in
visualizing the mid and posterior maxillary sinus.
Exposure settings for Maxillary Sinus program
100 VAC66 kV/6.3 mA66 kV/10 mA66 kV/13 mA73 kV/13 mA
230 VAC66 kV/6.3 mA66 kV/10 mA66 kV/13 mA73 kV/13 mA
< default >
210457 rev 7Instrumentarium Dental21
3 Imaging programs
Bitewing: Magnification 1.3
An orthogonal view of the dentition from the
canine and posterior.
Exposure settings for Bitewing program
100 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
230 VAC66 kV/5 mA66 kV/8 mA66 kV/10 mA70 kV/13 mA
< default >
22Instrumentarium Dental210457 rev 7
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