Instrumentarium Orthopantomograph OP200 D User manual

ORTHOPANTOMOGRAPH™ OP200 D
ORTHOCEPH™OC200 D
Installation & Adjustments Manual
5139799-100 rev. 9
ENGLISH
D500316, 9
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Copyright
Manufactured by
Code: 5139799-100 rev 9
Document code: D500316 rev 9
Copyright © 04/2018by PaloDEx Group Oy.
All rights reserved.
ORTHOPANTOMOGRAPH™, ORTHOCEPH™ and
CLINIVIEW™ are registered trademarks of Instrumentarium
Dental.
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.
Instrumentarium Dental, PaloDEx Group Oy
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. [phone]
Fax. [phone]
For service, contact your local distributor.
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5139799-100 rev 9 Instrumentarium Dental i
1 Introduction.................................................................................................................. 1
1.1 General ................................................................................................................. 1
1.2 Graphics symbols.................................................................................................. 3
1.3 Type and version................................................................................................... 5
1.4 Radiation protection guidelines ............................................................................. 7
1.4.1 Protection by distance................................................................................ 7
1.4.2 Control from a protected environment........................................................ 8
1.5 Laser lights............................................................................................................ 8
1.6 Emergency Stop Switch ........................................................................................ 9
1.7 Unit identification labels ...................................................................................... 10
1.8 Manufacturer’s liability......................................................................................... 12
1.9 Disposal .............................................................................................................. 13
2 Installation requirements and dimensions.............................................................. 15
2.1 Column options ................................................................................................... 15
2.2 Column mounting options ................................................................................... 16
2.3 OP/OC200 D recommended minimum installation dimensions .......................... 17
2.4 Unit orientation options ....................................................................................... 18
2.5 Site requirements and dimensions...................................................................... 19
2.5.1 Radiation shielding................................................................................... 19
2.5.2 Radiation Safety....................................................................................... 19
2.5.3 Package dimensions ................................................................................ 19
2.5.4 Door width ................................................................................................ 19
2.5.5 Patient Access Area................................................................................. 19
2.5.6 Location.................................................................................................... 20
2.5.7 Unit mounting ........................................................................................... 20
2.5.8 Floor ......................................................................................................... 20
2.5.9 Remote exposure button (optional).......................................................... 20
2.5.10 Mains connection ..................................................................................... 20
2.5.11 Protective ground ..................................................................................... 21
2.6 Tools and hardware ............................................................................................ 21
3 Preparing for the installation.................................................................................... 23
3.1 Checking the shipment........................................................................................ 23
3.1.1 Checking the boxes.................................................................................. 23
3.2 Opening the boxes .............................................................................................. 23
3.2.1 Unpacking the column.............................................................................. 23
3.2.2 Unpacking the carriage ............................................................................ 25
4 Hardware installation ................................................................................................ 27
4.1 Column installation.............................................................................................. 27
4.1.1 Wall mount bracket .................................................................................. 27
4.1.2 Optional fork stand installation ................................................................. 30
4.1.3 Erecting the column ................................................................................. 32
4.2 Vertical carriage installation ................................................................................ 34
4.2.1 Lifting and fastening the carriage ............................................................. 34
4.2.2 Adjusting and fastening the unit ............................................................... 38
4.2.3 Electrical connections .............................................................................. 39
4.2.4 Rotation lock removal............................................................................... 41
4.2.5 Carriage locking plate removal................................................................. 42
4.3 Digital Cephalostat installation (optional) ............................................................ 44
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ii Instrumentarium Dental 5139799-100 rev 9
4.3.1 Preparing the unit for cephalostat installation .......................................... 44
4.3.2 Unpacking the cephalostat....................................................................... 44
4.3.3 Cephalostat arm mounting ....................................................................... 46
4.3.4 Cephalostat electrical connections........................................................... 50
4.3.5 Cephalostat head mechanical adjustments ............................................. 51
4.4 Finalizing the hardware installation ..................................................................... 54
4.4.1 Mains voltage connection......................................................................... 54
4.4.2 Changing the mains voltage from 230 V to 110 V.................................... 56
4.4.3 Removing counterweight transport security bolts .................................... 58
4.4.4 Control panel............................................................................................ 59
4.4.5 Remote exposure button (optional).......................................................... 59
4.4.6 Installing the unit covers........................................................................... 60
4.4.7 PCI-board and fiber-optic cable installation ............................................. 60
4.4.8 Connecting the CCD sensor .................................................................... 61
4.4.9 Application software installation ............................................................... 62
4.4.10 Powering up the unit for the first time....................................................... 62
5 Digital unit adjustments and calibration ................................................................. 67
5.1 General instructions ............................................................................................ 67
5.2 STEP 1: Panoramic adjustments and calibrations .............................................. 68
5.2.1 Panoramic beam alignment check ........................................................... 68
5.2.2 Panoramic beam adjustment with autocollimator..................................... 70
5.2.3 Image layer check and alignment ............................................................ 73
5.2.4 Patient positioning laser lights check and alignment................................ 75
5.2.5 AEC calibration check and adjustment .................................................... 81
5.3 STEP 2: Optional cephalostat adjustment and calibration .................................. 83
5.3.1 Cephalostat beam passing the panoramic CCD sensor .......................... 83
5.3.2 Cephalostat beam check and alignment .................................................. 84
5.3.3 Secondary collimator check and adjustment............................................ 87
5.3.4 Beam alignment board sensors sensitivity check and adjustment........... 90
5.3.5 Ear holder check and alignment............................................................... 92
5.3.6 Patient positioning laser lights alignment ................................................. 95
5.3.7 Calibrating the nasion frequency.............................................................. 95
5.3.8 Installing cephalostat covers .................................................................... 96
6 Handing over the unit................................................................................................ 99
6.1 Panel functions.................................................................................................... 99
6.2 Dose settings .................................................................................................... 100
6.3 Quality checks................................................................................................... 100
6.3.1 Activating panoramic QA-mode ............................................................. 100
6.3.2 Activating cephalostat QA-mode............................................................ 100
6.3.3 QA test mode selection .......................................................................... 101
6.3.4 QA-image ............................................................................................... 101
6.3.5 IEC Quality Assurance ........................................................................... 103
6.4 Accessories and disposables............................................................................ 106
6.5 Application training............................................................................................ 106
6.6 Verifying real image quality ............................................................................... 107
6.6.1 Software settings for image viewing....................................................... 107
7 Appendix A, OP200 D installation
check list .................................................................................................................. 109
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5139799-100 rev 9 Instrumentarium Dental iii
8 Appendix B, Unit orientation change..................................................................... 111
8.1 Panoramic patient positioning orientation change ............................................ 111
8.2 Cephalostat orientation change ........................................................................ 115
9 Appendix C, Cephalostat upgrade ......................................................................... 119
9.1 Cephalostat upgrade kit content ....................................................................... 119
9.2 Unpacking instructions ...................................................................................... 121
9.3 Counter weight .................................................................................................. 121
9.3.1 Adding trim weights................................................................................ 121
9.4 Collimator and tubehead cover ......................................................................... 124
9.5 Installation of the cephalostat............................................................................ 125
9.6 Alignments ........................................................................................................ 125
10 Appendix D, Re-packing instructions.................................................................... 127
10.1 Preparing the unit for re-packing....................................................................... 127
10.1.1 Cephalostat head ................................................................................... 127
10.1.2 Carriage ................................................................................................. 128
10.2 Cephalostat package ........................................................................................ 130
10.3 Carriage package.............................................................................................. 131
10.4 Column package ............................................................................................... 133
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iv Instrumentarium Dental 5139799-100 rev 9
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1 Introduction
5139799-100 rev 9 Instrumentarium Dental 1
1 Introduction
1.1 General
ORTHOPANTOMOGRAPH™ OP200 D is a software
controlled diagnostic panoramic dental x-ray equipment for
producing high quality digital images of dentition and
TM-joints. ORTHOCEPH™ OC200 D is a more equipped
x-ray panoramic unit with cephalometric exposure option.
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.
This manual covers the installation of panoramic unit,
cephalostat option, PC system PCI board and optical link
between PC and OP200 D unit. For information about how
to use the OP200 D unit and CLINIVIEWTM software
please refer to the appropriate manuals.
Following manuals are shipped with the OP200 D:
OP200 D Installation & Adjustments Manual
OP200 D User Manual & Technical Specifications
Installation and User Manual for CLINIVIEW
software
These manuals and future updates are available on
request from Instrumentarium Dental.
In order to maintain safe and correct operation of the
OP200 D unit, read and follow carefully instructions
provided in this manual during the unit installation process.
Use only approved cables and plugs.
Mains connector types:
– NEMA 6-15P or similar Hospital grade (US/230 V)
– NEMA 5-20P or similar Hospital grade (US/110 V)
– HBL8215C or similar Hospital grade (JAPAN)
Power supply cord:
– For UL-countries: S or SO, AWG 14x3
– H05VV-F3G 10-16A 250V (CE)
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1 Introduction
2 Instrumentarium Dental 5139799-100 rev 9
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.
WARNING! SERVICING AND INSTALLING THIS UNIT
WITHOUT ADEQUATE EXPERTISE IS EXTREMELY
DANGEROUS. Instrumentarium Dental recommends that
all service operations are performed by Instrumentarium
Dental authorized service personnel!
WARNING! Prevent unauthorized access to unit during
the unit installation process. Some internal parts of the unit
contain dangerous voltage, which can be reached during
the installation, when the unit covers have been removed.
WARNING! The mains filter and connected cables are still
energized even when the unit is switched off (see wiring
diagram in chapter 4.4.1 Mains voltage connection). The
mains power cord must be unplugged from the wall socket
when the mirror plate is removed during the unit
installation.
WARNING! Some installation
procedures instructed in this
manual require X-radiation
exposures. Follow the local
regulations with radiation safety
issues.
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1 Introduction
5139799-100 rev 9 Instrumentarium Dental 3
1.2 Graphics symbols
The following symbols are used in the 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
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.
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1 Introduction
4 Instrumentarium Dental 5139799-100 rev 9
The following abbreviations are used in this manual.
PC Personal computer
HD Hard disk
Hz Hertz; cycles per second
MHz Millions of hertz
CPU Central processing unit (computer)
RAM Random access memory
MB Mega bytes
GB Giga bytes
CCD Charge-coupled device
CD-R Compact disc (read)
CD-RW Compact disc (read and write)
DVD-RW Digital Versatile Disc (read and write)
HDD High density drive
PCI Peripheral Component Interconnect
LAN Local Area Network
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1 Introduction
5139799-100 rev 9 Instrumentarium Dental 5
1.3 Type and version
The type and version of the OP200 D is defined in the unit
main label. It is located on the vertical carriage bottom
plate next to the power on/off switch or in the column label.
The unit is class I, type B and has IP-20 protection.
Fig 1.1. Location of main label
Type:
Ser. No:
Manufactured:
10 A 230 V~ 50 / 60Hz (1 A continuous)
This product complies with
DHHS 21 CFR
Chapter I,
Sub
chapter J at the date of manufacture.
Caution: Federal law restricts this device to
sale by or on the order of a dentist or other
qualified professional.
ETL CLASSIFIED
CONFORMS TO UL STD 60601
-1.
CERTIFIED TO CSA
STD C22.2 NO 601.1.
3174420
Manufactured by Instrumentarium Dental
D502470 / 3
Nahkelantie 160
FI
-04300 TUUSULA, Finland
Fig 1.2. Main label (110 V)Fig 1.2. Main label (230 V)
Type:
Ser. No:
Manufactured:
15 A 110 V~ 50 / 60Hz (1 A continuous)
This product complies with
DHHS 21 CFR
Chapter I,
Sub
chapter J at the date of manufacture.
Caution: Federal law
restricts this device to
sale by or on the order of a dentist or other
qualified professional.
ETL CLASSIFIED
CONFORMS TO UL STD 60601
-1.
CERTIFIED TO CSA
STD C22.2 NO 601.1.
3174420
Manufactured by Instrumentarium Dental
D502470 / 4
Nahkelantie 160
FI
-04300 TUUSULA, Finland
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1 Introduction
6 Instrumentarium Dental 5139799-100 rev 9
The type numbers appear in the following form:
OP200 D-a-bc-d-S.
For example, OP200 D-1-4-1 is:
(OP200 D) ORTHOPANTOMOGRAPH OP200 D
(-1) with D-051S tube
(-4) Removable combined panoramic and cephalostat
sensor
(-1) first version of OP200.
NOTE! In order to maintain safe and correct functioning of
OP200 D, only the approved accessories may be used.
TYPE AND VERSION
OP200 D short form for ORTHOPANTOMOGRAPH
OP200 D
OC200 D short form for ORTHOCEPH OC200 D
atype of the x-ray tube insert which is originally utilized:
1=D-051S
bc 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.
dversion number:
1 = OP200 models starting from s/n 100 000
Sindication of a "Special" version, marked only in
products which have a non-standard configuration
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1 Introduction
5139799-100 rev 9 Instrumentarium Dental 7
1.4 Radiation protection guidelines
X-ray equipment may cause injury if used improperly. The
instructions contained in this manual must be read and
followed with 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 a physician before taking images of
pregnant patients.
OP200 D is equipped with radiation protection in
accordance with IEC601-1-3:1994.
CAUTION! Use of controls or adjustments or performance
of procedures other than those specified herein may result
in hazardous radiation exposure.
1.4.1 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 x-
ray 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.
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1 Introduction
8 Instrumentarium Dental 5139799-100 rev 9
1.4.2 Control from a protected environment
The operator does not need to be close to the patient
during normal use. Control panel hand switch or optional
remote hand switch can be used from an environment
protected from the x-ray beam. 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).
1.5 Laser lights
1. FH-light
2. Midsagittal light
3. cephalostat light
4. Layer light
Fig 1.3. Laser light (CLASS 1 LASER PRODUCT). Max output 100µW.
12
3
4
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1 Introduction
5139799-100 rev 9 Instrumentarium Dental 9
1.6 Emergency Stop Switch
Fig 1.4.
An emergency stop switch is provided on the right side of
the unit carriage and on the bottom of the cephalostat head
so that the patient can reach either of 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 exposure cannot be continued
later, but has to be retaken from the beginning.
NOTE! Before switching the unit on ensure that the
emergency stop switches are released.
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1 Introduction
10 Instrumentarium Dental 5139799-100 rev 9
1.7 Unit identification labels
1. Cephalostat head label
2. Main Label
3. Unit serial number and type label
4. Midsagittal and FH-light laser
label
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1 Introduction
5139799-100 rev 9 Instrumentarium Dental 11
NOTE! Some labels listed above are related to some
options and may not be included in all countries.
5. Laser light warning label
6. Image layer laser light label
7. Collimator type label
8. X-ray generator and tubehead
label
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1 Introduction
12 Instrumentarium Dental 5139799-100 rev 9
1.8 Manufacturer’s liability
As manufacturer we can only assume liability of safe and
reliable operation of this unit when
Installation was performed according to the OP200 D
Installation & Adjustments Manual
The unit is used according to the OP200 D User
Manual
CLINIVIEW PC software was installed according to
the Installation Manual for CLINIVIEW software
CLINIVIEW software is used according to User
Manual for CLINIVIEW software
Maintenance and repairs are performed by a qualified
ORTHOPANTOMOGRAPH Dealer
Original or authorized spare parts are used
In order to guarantee maximal image quality for entire life
time of this high performance imaging system, we suggest
that the quality assurance procedure *) and optional digital
test tool kit designed for image quality assurance purposes
are used (part no. 68795). Also we recommend 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 (part no. 61049) every year
or after 2000 images. For more information please contact
your local dealer.
*) According 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.
The user should keep this work order for future references.
NOTE! For PC system: Some PC hardware or software
may be incompatible with OP PCI board or CLINIVIEW
software. Instrumentarium Dental can guarantee OP200 D
PCI board and CLINIVIEW software compatibility with
certain PC hardware and software only if that configuration
has been tested by Instrumentarium Dental. Any later
changes to the hardware or software may void this test.
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