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

Name: Instrumentarium Dental OP-200D
Brand: Instrumentarium Dental
SKU: 7458880
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ENGLISH

Orthopantomograph® OP200 D

Orthoceph® OC200 D

User Manual

5139796-100 rev. 7

Code: 5139796-100 rev 7 Date: 27 September 2012

Document code: D500319 rev 7

Orthopantomograph® and Orthoceph® are registered trademarks of Instrumentarium Dental. U.S. patents 6,731,717, 6,829,326 and USRE41197. Finnish patents 114383. Windows® is trademark of Microsoft Corporation in the United States of America and other countries. Pentium® is a registered trademark of Intel Corporation. Iomega® Jaz® is a registered trademark of 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.

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

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	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

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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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1Introduction

1.1General

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.

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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.

Fig 1.1. Location of main label and CE mark

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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	short form for ORTHOPANTOMOGRAPH®
	OP200 D

OC200 D	short form for ORTHOCEPH® OC200 D

a	type of the x-ray tube insert which is originally
	utilized:
	1	= Toshiba 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.

d	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.

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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.

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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 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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1.5.2 Laser lights

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).

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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

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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.

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WARNING! Do not stack or locate the unit close to other equipment.

2.1 OP200 D main parts

13	Optional cephalostat

8 9

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

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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

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19	17

Fig 2.5. Carriage bottom plate and unit main label

Fig 2.6. Optical fibre connectors in OP200 D

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22		23
25

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

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2.2 OC200 D Main parts



		6
		3
2	5	3
2	5

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

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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)

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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

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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.

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Radiation warning

2.4 Positioning panels

24 23 22 21

Fig 2.8. Positioning panel, right side

(on left side just the buttons 25 and 26 are flipped)

Positioning Panel button meaning in each mode

Key	Panoramic(P1-P5)	Maxillary Sinus (P8)

20	Carriage movement up and down

21	moves the image layer 3	moves the image layer
	mm anterior during	10 mm anterior from
	exposure	nominal position during
	(retrusion)	exposure

22	normal occlusion/reset	nominal position
	position

23	moves the image layer 3	moves the image layer
	mm posterior during	10 mm posterior from
	exposure	nominal position during
	(protrusion)	exposure

24	Positioning lasers (CLASS 1 LASER PRODUCT) on/off

25	Rotating unit movement: Start positioning

26	Rotating unit movement: Patient positioning


	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

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Positioning Panel button meaning in each mode

22	No functioning	reset to middle

23	No functioning	moves image layer
		posterior

24	Postioning lasers (CLASS 1 LASER PRODUCT) on / off

25	Rotating unit movement: Start positioning

26	Rotating unit movement: Patient positioning

Up movement

Down movement

Positioning light button

Fig 2.9. Positioning panel, cephalostat head

2.5 Patient positioning accessories

64197

68758

Fig 2.10. Panoramic patient positioning accessories

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60477

Fig 2.11. TMJ patient positioning accessories

68696

200634

Part	Part description:	Part	Part description:
code:		code:

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)

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Part	Part description:	Part	Part description:
code:		code:

50076	Child adaptor

6722	Chin support

62965	Edentulous bite
	positioner, optional

68696	Cephalostat mirror	20063	Carpus support
	assembly (optional	4	(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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