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
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)
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•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 dentist 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 (bitewing
exposures) would be sufficient.
Cone beam computed tomography images are not
adequate for the analysis of soft tissue.
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1.6.2Warnings to be observed during
installation and service
Before attempting to service the device make sure that you
know how to operate it. Read the user’s manual.
Read and familiarize yourself with the warnings and
precautions listed in the user’s manual.
Only use original spare parts from the manufacturer when
repairing the device or replacing parts.
Warning - Radiation Safety
Before servicing the unit familiarize yourself with local and
national radiation safety standards and requirements
relating to dental x-ray equipment.
Warning - Electrical Safety
Disconnect the unit from the main power supply before
removing any covers.
Disconnect the unit from the main power supply before
repairing or replacing mechanical parts or installing
accessories.
Be careful when operating the unit not to get body parts or
clothing trapped between moving parts.
AES exposure settings shall be checked by the operator
before taking exposures.Disconnect the unit from the
mains power connection before servicing the unit, e.g.
replacing circuit boards or other electrical components.
If there are capacitors on a circuit board or electrical device
wait ten (10) minutes, after disconnecting the unit from the
power supply, before handling the board or device.
If you have to leave the unit unattended with covers
removed during servicing or maintenance, disconnect the
unit from main power supply so that anyone who
inadvertantly touches the unit does not receive an electric
shock.
This unit should only be used in areas that are provided
with a protective earth connection to ensure an
equipotential ground connection.
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Some disinfectants and cleaning agents may vaporize to
form an explosive vapour. If such disinfectants and
cleaning agents are used the vapour should be allowed to
disperse before switching the unit on.
Warning - Cleaning the unit
Switch the unit off and disconnect it from the main power
supply before cleaning or disinfecting the unit.
The aperture plate and the tube housing are made of lead
(Pb), which is a toxic material. Do not touch it with your
bare hands.
The installer must ensure that:
•The fixing screws are suitable for the wall material.
•The wall for fixing the unit is strong enough for attaching the unit. It must withstand loads of 5000N
or more.
•Pull out strength of the screws is 5000N or more.
•The wall fixing screws are adequately tightened.
To avoid the unit from tipping over, fix the unit with floor
bolts appropriate to the surface the unit is mounted on. The
bolts and the floor material must endure force of 5000 N.
The installer must ensure that the upper shelf attachment
screws are tightened.
The unit should be installed in a place with enough space
for safe operation. See the unit installation manual for
recommended minimum site dimensions. It is the
responsibility of the customer to ensure that the site is
large enough for the patients.
Be aware of hot surfaces when removing covers during
installation and maintenance.
When installing a dental X-ray unit always observe local
and national safety, radiation control and electrical
regulations.
1.6.2.1Cautions for Electrostatic discharge
Electrostatic Discharge (ESD) can damage or destroy
electronic components.
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When servicing the device take precautions to avoid
electrostatic build up and discharge (ESD). Follow the
recommendations for the prevention of ESD that are used
in the country in which you are working. If no
recommendations are available follow the guide lines
below.
Leave all new or replacement circuit boards and electrical
parts in their protective packaging until the boards are
needed.
Before handling circuit boards and electrical parts make
sure that any static electricity charge that has built up in
you body is discharged.
When handling circuit boards hold them by their edges and
do not touch any connectors or components.
When examining and checking circuit boards use an
elasticated wrist wrap which is connected to a ground point
through a 1 Mohm current limiting cable. For a ground
point use water pipes, radiators or other objects that are
known to be connected to the ground. Also use a cable to
connect the x-ray unit to the same ground potential as the
wrist wrap.
If an antistatic mat is used, connect the wrist wrap to the
mat and the mat to the ground potential.
Wash the wrist wrap and check that it is in good condition
frequently.
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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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.
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 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.
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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
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.
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Unauthorized changes or modifications to any part of the
unit or its equipment can have hazardous consequences.
Changes or modifications must not be made unless
specifically authorized by the manufacturer. When properly
assembled with a compatible beam limiting device, the
diagnostic source assembly will fully meet the United
States of America Federal Performance Standards for
Diagnostic X-Ray Systems and Their Components (21
CFR 1020. 30-32) provided. No parts may be removed
from the unit and no unauthorized adjustments are made to
the beam limiting device or tube housing assembly.
Never remove or remanufacture any part of the tubehead
assembly or beam limiting device. Never adjust any part of
the beam limiting device unless under the direction of the
manufacturer or their authorized distributor.
1 Introduction
1.8Disclaimer
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.
1.9Disposal
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:
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.
Press to stop the unit, rotate to release.
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