Instrumentarium Dental OP-200D, OC-200D User Manual

Orthopantomograph
®
OP200 D
Orthoceph® OC200 D
User Manual
5139796-100 rev. 7
Copyright Code: 5139796-100 rev 7 Date: 27 September 2012
Document code: D500319 rev 7
Copyright © 09/2012 by PaloDEx Group Oy. All rights reserved.
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 by Instrumentarium Dental, PaloDEx Group Oy
Nahkelantie 160 (P.O. Box 20) FI-04300 Tuusula FINLAND Tel. +358 10 270 2000 Fax. +358 9 851 4048
For service, contact your local distributor.
Table of Contents
1 Introduction.................................................................................................................. 1
1.1 General ................................................................................................................. 1
1.2 Markings and graphics symbols............................................................................ 2
1.3 Type and version................................................................................................... 3
1.4 Options, accessories and manuals ....................................................................... 5
1.5 Radiation protection guidelines ............................................................................. 6
1.5.1 Protection by distance................................................................................ 6
1.5.2 Laser lights................................................................................................. 7
1.5.3 Control from a protected environment........................................................ 7
1.5.4 Emergency Stop Switch ............................................................................. 8
1.6 Manufacturer’s liability........................................................................................... 8
1.7 Disposal ................................................................................................................ 9
2 OP200 D controls and accessories.......................................................................... 11
2.1 OP200 D main parts............................................................................................ 11
2.2 OC200 D Main parts ........................................................................................... 15
2.3 Control panel....................................................................................................... 16
2.4 Positioning panels ...............................................................................................19
2.5 Patient positioning accessories........................................................................... 20
2.6 Disposables & Service accessories .................................................................... 22
2.7 Changing the fuses ............................................................................................. 24
3 Equipment care and preparations............................................................................ 25
3.1 Care Instructions ................................................................................................. 25
3.2 Cleaning recommendations ................................................................................ 25
3.2.1 Cleaning ................................................................................................... 25
3.2.2 Disinfection and sterilization..................................................................... 26
3.2.2.1 Autoclave................................................................................... 26
3.2.2.2 Steam sterilization ..................................................................... 26
3.2.2.3 Ethylene oxide sterilization ........................................................ 27
3.2.3 Other sterilization processes.................................................................... 27
3.2.3.1 Dry heat sterilization .................................................................. 27
3.2.3.2 Liquid chemical sterilant gases.................................................. 27
3.2.3.3 Chemical sterilant gases............................................................ 27
3.3 Connecting and disconnecting the CCD sensor .................................................28
3.4 Preparation for panoramic image acquisition...................................................... 30
3.5 Selecting collimator height with automatic collimator.......................................... 32
4 Panoramic procedures.............................................................................................. 33
4.1 P1: Standard panoramic exposure...................................................................... 33
4.2 P2: Pediatric panoramic exposure ...................................................................... 41
4.3 P3: Ortho Zone enhanced panoramic exposure ................................................. 44
4.4 P4: Orthogonal exposure .................................................................................... 46
4.5 P5: Wide arch panoramic exposure ....................................................................48
5 Special imaging procedures.....................................................................................51
5.1 BW: Bitewing exposure .......................................................................................51
5.2 P6: TMJ, Lateral projection ................................................................................. 52
5139796-100 rev 7 Instrumentarium Dental i
5.3 P6: Ortho TMJ, axial corrected lateral projection (optional) ................................ 56
5.4 P7: TMJ, posterioranterior projection ..................................................................60
5.5 P8: Maxillary Sinus view ..................................................................................... 61
6 Cephalometric procedures (optional)...................................................................... 65
6.1 Preparing the operation....................................................................................... 65
6.2 P9a: Cephalo Core Lateral projection
P9b: Lateral projection ........................................................................................ 65
6.3 P10: Cephalo postero-anterior (PA) projection ................................................... 68
6.4 P10: Reverse Towne projection exposure .......................................................... 70
6.5 P10: Waters view exposure ................................................................................ 71
6.6 P10: Carpus view exposure (holder optional) .....................................................72
7 Imaging technique..................................................................................................... 75
7.1 Automatic exposure control (AEC)...................................................................... 75
7.2 AEC test .............................................................................................................. 76
7.3 Exposure technique factors................................................................................. 76
7.4 Manual mode ...................................................................................................... 78
7.5 Free selection of kV and mA ...............................................................................79
7.6 Test mode ........................................................................................................... 80
7.7 Measurements from the image ........................................................................... 81
8 Special features ......................................................................................................... 83
8.1 Basic quality assurance ...................................................................................... 83
8.2 Advanced QA (optional) ......................................................................................84
8.3 Exposure counter ................................................................................................85
8.4 Preventive maintenance reminder ...................................................................... 85
9 Understanding the OP200 D image.......................................................................... 87
10 Failure diagnostics ................................................................................................... 89
10.1 Failure messages................................................................................................ 89
10.2 kV display............................................................................................................ 89
10.3 mA display........................................................................................................... 90
10.4 Time display ........................................................................................................ 90
10.5 Resetting a failure ............................................................................................... 90
10.6 Failure codes....................................................................................................... 92
11 Diagnosing image quality problems .......................................................................93
11.1 Patient positioning problems ...............................................................................93
11.2 Image appearance problems ..............................................................................96
11.3 Artefacts .............................................................................................................. 97
11.4 Unit operation...................................................................................................... 98
12 How to use the user programming mode............................................................. 101
12.1 General ............................................................................................................. 101
12.2 Installation and unit configuration programs .....................................................101
12.3 Programs affecting image quality...................................................................... 102
12.4 Other Pr programs ............................................................................................ 103
12.5 How to use the user programming mode .......................................................... 103
ii Instrumentarium Dental 5139796-100 rev 7
13 User program features ...........................................................................................105
13.1 Pr 50 S3d: Volumetric Tomography settings..................................................... 105
13.2 Pr 51 PUS: Power up settings........................................................................... 106
13.3 Pr 52 PCo and Pr 52 gCo:
Constant contrast & density settings................................................................. 106
13.4 Pr 53 nor: Resume normal settings................................................................... 109
13.5 Pr 54 Arn: Rotating unit autoreturn ................................................................... 110
13.6 Pr 57 Hon: Patient positioning side ................................................................... 110
13.7 Pr 58 CON: Vertebrae shadow compensation ..................................................111
13.8 Pr 59 PSE: Preventative maintenance reminder............................................... 113
13.9 Pr 60 bEP: Panel beep...................................................................................... 114
13.10 Pr 61 CLC: Clear exposure counter................................................................. 115
13.11 Pr 62 ERR: Last failure code ........................................................................... 115
13.12 Pr 63 CEL: Cephalostat exposure limit............................................................ 116
13.13 Pr 64 FSt: Fast scanning selection .................................................................. 116
13.14 Pr 65 doS: Dose / time display selection ......................................................... 117
13.15 Pr 66 COU: Exposure counters ....................................................................... 119
13.16Pr 67 qUA: Quality assurance .......................................................................... 120
14 User statement........................................................................................................ 121
14.1 Dose area product (DAP).................................................................................. 126
15 Technical specifications ........................................................................................ 129
15.1 Electromagnetic Compatibility (EMC) tables..................................................... 138
16 Maintenance ............................................................................................................ 145
16.1 Maintenance Schedule...................................................................................... 145
16.2 Monthly Inspection by User............................................................................... 145
16.3 Preventive maintenance Reminder ...................................................................146
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iv Instrumentarium Dental 5139796-100 rev 7

1 Introduction

1.1 General

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.
OP200 D performs the following procedures:
Standard panoramic exposure Pediatric panoramic exposure Ortho Zone enhanced panoramic exposure Wide arch panoramic exposure Orthogonal panoramic exposure Maxillary sinus TMJ, lateral projection or Ortho TMJ axial corrected lateral projection (optional) TMJ, PA projection Bitewing exposure
®
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 7 Instrumentarium Dental 1
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.

1.2 Markings 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.
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1.3 Type 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 7 Instrumentarium Dental 3
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.
4 Instrumentarium Dental 5139796-100 rev 7
1 Introduction

1.4 Options, 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 7 Instrumentarium Dental 5
1 Introduction

1.5 Radiation 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.
6 Instrumentarium Dental 5139796-100 rev 7

1.5.2 Laser lights

1 Introduction
Fig 1.2. Laser light (CLASS 1 LASER PRODUCT). Max output 100µW.

1.5.3 Control from a protected environment

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 7 Instrumentarium Dental 7
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.

1.6 Manufacturer’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
8 Instrumentarium Dental 5139796-100 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.

1.7 Disposal

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 7 Instrumentarium Dental 9
1 Introduction
10 Instrumentarium Dental 5139796-100 rev 7

2 OP200 D controls and accessories

1
2
3
4
5
6 7
8
9
10
11
12
13
Optional cephalostat
2 OP200 D controls and accessories
WARNING! Do not stack or locate the unit close to other
equipment.

2.1 OP200 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 7 Instrumentarium Dental 11
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
12 Instrumentarium Dental 5139796-100 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 7 Instrumentarium Dental 13
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
14 Instrumentarium Dental 5139796-100 rev 7

2.2 OC200 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 7 Instrumentarium Dental 15
2 OP200 D controls and accessories

2.3 Control 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.
Imaging Procedures P1-P12 with Indicator lights
Standard Panoramic (P1)
Pediatric Panoramic (P2)
Ortho Zone enhanced Panoramic (P3)
Orthogonal Panoramic (P4)
Bitewing (BW)
16 Instrumentarium Dental 5139796-100 rev 7
2 OP200 D controls and accessories
Wide arch Panoramic (P5)
TMJ lateral projection (P6) or Ortho TMJ, axial corrected lateral projection (optional) (P6)
TMJ, posterior-anterior projection (P7)
Maxillary Sinus View (P8)
Cephalo Core Lateral Projection (P9a)
Cephalo Lateral Projection (P9b)
Cephalo Postero-Anterior (PA) projection (P10)
Volumetric Tomography mandible (optional) (P11)
Volumetric Tomography maxilla (optional) (P12)
Exposure Modes with Indicator lights
Automatic Exposure Control
Test Mode
Manual Exposure Control
5139796-100 rev 7 Instrumentarium Dental 17
2 OP200 D controls and accessories
Automatic exposure signal to noise ratio (9 dose control steps)
Default Signal to Noise ratio
Decrease dose by one and half step
Half step higher dose
Displays showing exposure values
kV display
mA display
Exposure time display / Radiation dose display
Icons for Pre-programmed Technique Factors with Indicator lights
Child - Juvenile - Adult - Large adult
Function Selection buttons:
Move the flashing indicator to left or right / decrease or increase the value on display
Move the flashing indicator up or down to the next selection row
P1-P10: Show exposure counter value P11-P12: Show projection angle and number of images All programs: Clear errors
NOTE! The OK button is also used for entering and exiting programming mode. See chapter User program features for details.
18 Instrumentarium Dental 5139796-100 rev 7
Radiation warning
26
25
24
23 22
21
20
20

2.4 Positioning panels

Fig 2.8. Positioning panel, right side (on left side just the buttons 25 and 26 are flipped)
2 OP200 D controls and accessories
Positioning Panel button meaning in each mode
Key Panoramic(P1-P5) Maxillary Sinus (P8)
20
21 moves the image layer 3
mm anterior during exposure (retrusion)
22 normal occlusion/reset
Carriage movement up and down
moves the image layer 10 mm anterior from nominal position during exposure
nominal position
position
23 moves the image layer 3
mm posterior during exposure (protrusion)
24
25
26
Positioning lasers (CLASS 1 LASER PRODUCT) on/off
Rotating unit movement: Start positioning
Rotating unit movement: Patient positioning
moves the image layer 10 mm posterior from nominal position during exposure
Positioning Panel button meaning in each mode
Key Cephalometric (P9-P10) TMJ (P6-P7)
20
Carriage movement up and down
21 No functioning moves image layer
anterior
5139796-100 rev 7 Instrumentarium Dental 19
2 OP200 D controls and accessories
Positioning light button
Down movement
Up movement
64197
68758
Fig 2.10. Panoramic patient positioning accessories
22 No functioning reset to middle
23 No functioning moves image layer
Positioning Panel button meaning in each mode
posterior
24
25
26
Postioning lasers (CLASS 1 LASER PRODUCT) on / off
Rotating unit movement: Start positioning
Rotating unit movement: Patient positioning
Fig 2.9. Positioning panel, cephalostat head

2.5 Patient positioning accessories

20 Instrumentarium Dental 5139796-100 rev 7
2 OP200 D controls and accessories
60477
Fig 2.11. TMJ patient positioning accessories
68696
200634
Part code:
Part description:
Part code:
Part description:
68758 Chin rest 62904*Nose support, long
64197 Sinus rest 62906*Nose support,
short
62942*Bite block 10 pcs 60477 TMJ pointer
62985*Bite fork, short 56 mm 64665 TMJ angle
indicator (Ortho TMJ option)
62988*Bite fork 71 mm 62943 TMJ chin rest
(Ortho TMJ option)
62958*Bite fork, long 80 mm,
optional (not shown)
5139796-100 rev 7 Instrumentarium Dental 21
2 OP200 D controls and accessories
Part code:
Part description:
Part code:
Part description:
50076 Child adaptor
6722 Chin support
62965 Edentulous bite
positioner, optional
68696 Cephalostat mirror
assembly (optional
200634Carpus support
(optional)
for right hand ceph)
NOTE! The parts marked with * are autoclavable.
Convenient bins for small accessories and disposables are located on the both sides of the vertical carriage.
Fig 2.12. Left and right accessory cabins

2.6 Disposables & Service accessories

The following accessories, disposables and tools are available for the equipment:
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