Orthopantomograph® and Orthoceph® are registered trademarks
of Instrumentarium Dental. U.S. patents 6,731,717, 6,829,326
and USRE41197. Finnish patents 114383. Windows
trademark of Microsoft Corporation in the United States of
®
America and other countries. Pentium
®
of Intel Corporation. Iomega
Jaz® is a registered trademark of
is a registered trademark
Iomega Corp.
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.
®
is
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.
Manufactured byInstrumentarium Dental, PaloDEx Group Oy
INSTRUMENTARIUM DENTAL® Orthopantomograph
OP200 D panoramic unit (hereafter called “OP200 D”) is a
software controlled diagnostic panoramic dental X-ray
equipment for producing high quality digital images of
dentition, TM-joints and skull. In order to take images with
OP200 D you need a suitable PC hardware connected to
the OP200 D unit and CLINIVIEWTM software to handle
images.
Orthoceph® OC200 D is a more equipped x-ray panoramic
unit with cephalometric exposure option (hereafter called
“OC200 D”) . In addition to the OP200 D functions OC200
D performs the following cephalometric procedures:
lateral view
posterior-anterior (PA) and anterior-posterior (AP)
views
The basic OP200 D can be upgraded later to the
Orthoceph® OC200 D.
A minimum complete system contains the X-ray unit itself
(with all of its accessories) and the modality workstation
(PC) that is connected to the unit. However note that where
as the rest of the system is installed to the patient
environment, the modality workstation or any other PC
may have restrictions to the place of installation referenced
to that environment.
As the manufacturer we strongly recommend that you read
this manual before taking the unit into use.
5139796-100 rev 7Instrumentarium Dental1
1 Introduction
NOTE! OP200 D Must be installed according to the
OP200 D installation & Adjustments manual by a
qualified technician. Only trained personnel should
be allowed to operate OP200 D.
1.2Markings and graphics symbols
The following symbols are used in OP200 D:
Radiographic control
Protective earth (ground)
Type B equipment
GOST-R A certification that the products
qualifies for safety requirements in Russia
Dangerous voltage
On (Power)
Off (Power)
Attention, consult accompanying documents
If the unit has CE-marking it is CE-marked
according to the Medical Device Directive 93/
42/EEC.
ETL symbol
This symbol indicates that the waste of
electrical and electronic equipment must not
be disposed as unsorted municipal waste and
must be collected separately. Please contact
an authorized representative of the
manufacturer for information concerning the
decommissioning of your equipment.
2Instrumentarium Dental5139796-100 rev 7
1.3Type and version
The type and version of OP200 D is defined in the main
label of the unit located on the vertical carriage bottom
plate next to the power on/off switch or in the column label
of the unit located on the column. The unit is class I, type B
and with IP-20 protection.
1 Introduction
Fig 1.1. Location of main label and CE mark
5139796-100 rev 7Instrumentarium Dental3
1 Introduction
The type and version of the unit can be read from the main
label or column label codes. The type numbers appear in
the following form: OP200 D-a-bc-d-S.
TYPE AND VERSION
OP200 D
OC200 D
a
bc
d
short form for ORTHOPANTOMOGRAPH®
OP200 D
short form for ORTHOCEPH® OC200 D
type of the x-ray tube insert which is originally
utilized:
1 = Toshiba D-051S
the type of Panoramic sensor (b) and Cephalostat
sensor (c):
0 = No sensor = No type number
1 = PAN sensor, fixed
2 = PAN sensor, removable
3 = CEPH sensor, fixed
4 = PAN / CEPH sensor, removable
NOTE: Number can be for example “24” meaning
both PAN sensor and PAN/CEPH sensor.
version number:
1 = OP200 models starting from s/n 100 000
S
indication of a "Special" version, marked only in
products which have a non-standard modification
For example, OP200 D-1-4-1 is:
®
(OP200 D) Orthopantomograph
OP200 D
(-1) with Toshiba D-051S tube
(-4) Removable combined panoramic and cephalostat
sensor
(-1) first version of OP200.
4Instrumentarium Dental5139796-100 rev 7
1 Introduction
1.4Options, accessories and manuals
The options are listed in the appendices. The accessories
are listed in sections 2.5 and 2.6. All standard items and
approved accessories are suitable for use within the
patient environment.
WARNING! This product itself complies IEC601-1-1
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 OP/OC200 D 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 601-1standard and that is
indicated in the accompanying documents of the PC.
NOTE! In order to maintain safe and correct functioning of
OP200 D, only the approved accessories may be used.
CAUTION! Use of controls or adjustments or performance
of procedures other than those specified herein may result
in hazardous radiation exposure.
Following manuals and documents are shipped with the
OP200 D:
OP200 D / OC200 D
Installation & Adjustments Manual
OP200 D / OC200 D User Manual
Installation & User Manual for CLINIVIEWTM software
These manuals and future updates are available on
request from the manufacturer.
5139796-100 rev 7Instrumentarium Dental5
1 Introduction
1.5Radiation protection guidelines
X-ray equipment may cause injury if used improperly. The
instructions contained in this manual must be read and
followed when operating the Orthopantomograph® OP200
D. All government and local regulations pertaining to
radiation safety must be observed.
NOTE! For USA: Many provisions of these regulations are
based on recommendations of the National Council on
Radiation Protection and Measurements.
Recommendations for dental x-ray protection are
published in NCRP Report #35 available from NCRP
Publications, 7910 Woodmont Avenue, Suite 1016,
Bethesda, MD 20814.
Personal radiation monitoring and protective devices are
available and recommended for staff members. It is also
recommended to provide the patient with a protective
apron. Consult the physician before taking images of
pregnant patients.
WARNING! OP200 D must not be used in rooms where an
explosion hazard exists. Equipment not suitable for use in
the presence of flammable mixtures.
OP200 D with radiation protection in accordance with
IEC601-1-3:1994.
1.5.1 Protection by distance
In all examinations the user of the x-ray equipment should
wear protective clothing. The operator does not need to be
close to the patient during normal use. The protection
against stray radiation can be achieved by using the hand
switch not less than 2 m (7 ft) from the focal spot and the xray beam. 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.
Caution information on control panel:
CAUTION X-RAYS
ATTENTION
RAYONS X
WARNING:
This x-ray unit may be dangerous to patient and operator
unless safe exposure factors, operating instructions and
maintenance schedules are observed.
The control panel hand switch or optional remote hand
switch can be used from an environment protected from
the x-ray radiation. The fully extended spiral cable length of
the control panel hand switch is approx. 4 m (13 ft). The
cable length of the remote hand switch (part no. 69961) is
approx. 10 m (32 ft).
5139796-100 rev 7Instrumentarium Dental7
1 Introduction
1.5.4 Emergency Stop Switch
In case of malfunction of the exposure button release or
other protective devices of the unit, an emergency stop
switch is provided on the right side of the unit 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.
1.6Manufacturer’s liability
As a manufacturer we can only assume liability of safe and
reliable operation of this unit when
OP200 D unit installation was performed according to
the OP200 D Installation & Adjustments Manual and
OP200 D Unit is used according to the OP200 D User
Manual
CLINIVIEWTM PC software was installed according to
the Installation Manual for CLINIVIEWTM software.
CLINIVIEWTM software is used according to User
Manual for CLINIVIEWTM software.
Maintenance and repairs are performed by a qualified
Orthopantomograph® Dealer and
Original or authorized spare parts are used
In order to guarantee maximal image quality for the entire
life time of this high performance imaging system, we
suggest that a special image quality assurance procedure
(* and test object designed for image quality assurance
8Instrumentarium Dental5139796-100 rev 7
1 Introduction
purposes is used (code 68795). Also we recommend that a
qualified serviceman to check the unit to be in its original
condition regarding electrical, radiation and mechanical
safety according to our maintenance program described in
more details in maintenance manual (code 61049) every
year or after 2000 images. For more information please
contact your local dealer.
*) According to EN61223-3-4 and DIN 6868-151
If service on the unit is performed, a work order describing
the type and extent of repair must be provided by the
service technician. This must contain information of
changes of nominal data or work range performed. The
work order must furthermore indicate the date of repair, the
name of the company concerned and a valid signature.
User should keep this work order for future references.
NOTE! Only use PC hardware that has been tested to be
compatible with the OP 200 D PCI board and
CLINIVIEWTM software.
NOTE! Certain changes to the hardware may void the
compatibility. Contact your local dealer for up-to-date
information on this matter.
1.7Disposal
At the end of useful service life of the device, its spare
parts, its replacement parts and its accessories make sure
that you follow all local, national and international
regulations regarding the correct and safe disposal and/or
recycling of the device, its spare parts, its replacement
parts and its accessories.
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.
The locations of all parts that are made of or include
materials that are non-environmentally friendly or
hazardous can be found in the device service manual.
5139796-100 rev 7Instrumentarium Dental9
1 Introduction
10Instrumentarium Dental5139796-100 rev 7
2 OP200 D controls and accessories
1
2
3
4
5
67
8
9
10
11
12
13
Optional cephalostat
2OP200 D controls and accessories
WARNING! Do not stack or locate the unit close to other
equipment.
2.1OP200 D main parts
1.CCD sensor
2.CCD sensor holder
3.Main support
4.Rotating unit
5.Head and Temple support
6.Bite fork with rod
7.Chin rest
8.Handles
9.Positioning panel
5139796-100 rev 7Instrumentarium Dental11
2 OP200 D controls and accessories
15
10. Control panel
11. Exposure indicator lights
12. FH laser (CLASS 1 LASER PRODUCT) light height
adjustment
13. Mirror
14. PC equipment
Fig 2.3. PC equipment
15. Remote exposure button and holder
(optional in some markets)
Fig 2.4. Remote exposure button
12Instrumentarium Dental5139796-100 rev 7
2 OP200 D controls and accessories
19
18
17
16
21
20
Fig 2.5. Carriage bottom plate and unit main label
Fig 2.6. Optical fibre connectors in OP200 D
5139796-100 rev 7Instrumentarium Dental13
2 OP200 D controls and accessories
25
2
2322
Fig 2.7. Optical fibre connectors in PC
16. Main label
17. Power ON / OFF switch with an indicator
NOTE! When unit has been switched ON, wait about one
minute until the unit is ready to exposure.
18. Main fuses with label
19. Connector for Control panel
20. Optical fiber link connectors at OP200 D (transmitter
and receiver)
21. Cephalostat main cable (only in OC200 D units)
22. Optical fiber link connectors at PCI card (transmitter
and receiver)
23. PCI board status leds
14Instrumentarium Dental5139796-100 rev 7
2.2OC200 D Main parts
1
2
3
4
5
6
7
8
9
2
2 OP200 D controls and accessories
1.Cephalostat head
2.Control buttons
3.CCD sensor
4.Secondary collimator
5.Ear rod with pin
6.Nasion support with scale
7.Locking knob for ear rod rotation
8.Ear rod brake release button
9.Knob for raising and lowering the CCD sensor
5139796-100 rev 7Instrumentarium Dental15
2 OP200 D controls and accessories
2.3Control panel
Exposure Control
Exposure Button
Exposure Indicator light
“Ready” Indicator light
Pediatric Collimator light
Sections
1.Anterior
2.Premolar
3.Molar
4.Jaw joint
NOTE! Sections 2 and 3 are combined as one section in
panoramic programs.