ProOne User Manual Rev 9 Release June 2011

TABLE OF CONTENTS

1

INTRODUCTION ...1

2

SYMBOLS ON PRODUCT LABELS ...2

3

ASSOCIATED DOCUMENTATION ...2

4

WARNINGS AND PRECAUTIONS ...3

5

MAIN PARTS ...5 5.1 5.2 5.3 5.4 5.5

General view of the system ... 5 General view of the X-ray unit ... 6 Exposure switch ... 7 Patient supports ... 8 Emergency stop button ... 8

6

SWITCHING THE X-RAY UNIT ON ...9

7

PROGRAM PACKAGES ...10

8

CONTROL PANEL ...11 8.1 General about control panel ... 11 8.2 Selecting panoramic exposure program ... 12 8.3 Selecting temporomandibular joint (TMJ) exposure program ... 17 8.4 Selecting sinus exposure program ... 22 8.5 Selecting Cross sections exposure program (optional) ... 25 8.6 Entering patient name ... 29 8.7 Selecting patient size ... 30 8.8 Selecting kilovolt and milliampere values ... 30 8.9 Selecting jaw size and shape ... 32 8.10 Adjusting unit height ... 33 8.11 Returning C-arm to patient entry position ... 33 8.12 Opening/closing temple supports ... 33 8.13 Adjusting layer light position ... 34 8.14 Switching DEC on/off (optional) ... 34 8.15 Switching Autofocus on/off ... 35 8.16 Settings ... 35

9

PANORAMIC EXPOSURE ...61 9.1 9.2 9.3 9.4

10

Patient positioning ... 62 Taking an exposure ... 66 Taking an exposure with DEC ... 67 Taking an exposure with Autofocus ... 67

TEMPOROMANDIBULAR JOINT EXPOSURE ...70 10.1 Double TMJ exposure (lateral, PA or lateral-PA) ... 70 10.2 Multi-angle TMJ exposure (3 angles lateral) ... 77

11

SINUS EXPOSURE ...82 11.1 Patient positioning ... 83 11.2 Taking an exposure ... 85

12

CROSS-SECTIONAL EXPOSURE (OPTIONAL) ...87 12.1 Patient positioning ... 88 12.2 Taking an exposure ... 92

13

CLEANING ...95

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TABLE OF CONTENTS

14

SERVICE ...95

15

DISPOSAL ...96

16

HELP MESSAGES ...98

17

ERROR MESSAGES ...101

18

TECHNICAL SPECIFICATIONS ...102 18.1 Dimensions ... 103

The manufacturer, assembler, and importer are responsible for the safety, reliability and performance of the unit only if: - installation, calibration, modification and repairs are carried out by qualified authorized personnel - electrical installations are carried out according to the appropriate requirements such as IEC 60364 - equipment is used according to the operating instructions. Planmeca pursues a policy of continual product development. Although every effort is made to produce up-to-date product documentation, this publication should not be regarded as an infallible guide to current specifications. We reserve the right to make changes without prior notice. COPYRIGHT PLANMECA PUBLICATION NUMBER 10016256 Revision 9 Released 27 June 2011

ii Planmeca ProOne

User’s Manual

INTRODUCTION

1

INTRODUCTION The Planmeca ProOne X-ray unit produces digital X-ray images for the diagnosis of dentomaxillofacial anatomy. The unit is allowed to be used only under supervision of a dental/health care professional. This manual describes how to operate the Planmeca ProOne X-ray unit. Please read these instructions thoroughly before using the unit. You need a PC with the Planmeca Romexis/Dimaxis imaging software to save, view and modify the radiographs. The Romexis/Dimaxis software has a separate manual which should be used in conjunction with this manual. 0537

Planmeca ProOne X-ray unit fulfils the requirements of Directive 93/42/EEC (Class IIb).

CAUTION FOR US USERS: Federal law restricts this device to sale by or on the order of a dentist. NOTE The X-ray unit’s software version is shown briefly on the control panel when the X-ray unit is switched on. This manual is valid for software version 1.7.0.0.r or later. This software version is compatible with Romexis software version 2.4.0.R or later and Dimaxis software version 4.5.0.0.r or later. The display values shown in this manual are only examples and should not be interpreted as recommended values unless otherwise stated. The Planmeca ProOne X-ray unit features preset exposure values for all imaging programs. The exposure values have been preset at the factory to automatically correspond with the selected patient size. However, the exposure values required to produce good X-ray images vary considerably according to the build and age of the patient. The preset exposure values are average values and they are only meant to guide the user. Users are encouraged to develop their own radiographic techniques based on these values. Make sure that you are fully acquainted with the appropriate radiation protection measures and these instructions before using the X-ray unit.

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SYMBOLS ON PRODUCT LABELS

2

SYMBOLS ON PRODUCT LABELS Type B applied part (Standard IEC 60601-1)

Attention, consult accompanying documents (Standard IEC 60601-1)

Separate collection for electrical and electronic equipment according to Directive 2002/96/EC (WEEE).

Alternating current (Standard IEC 60417)

Warning: dangerous voltage (Standard IEC 60417)

Electrostatic sensitive device (Standard IEC 60417)

3

ASSOCIATED DOCUMENTATION The Planmeca ProOne X-ray unit is supplied with the following manuals: - User’s Manual - Installation Manual - Technical Manual These manuals are intended to be used in conjunction with the documentation for the Planmeca Romexis/ Dimaxis imaging software. The imaging software package contains the following manuals: - User’s Manual - Installation Manual

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WARNINGS AND PRECAUTIONS

4

WARNINGS AND PRECAUTIONS CAUTION This X-ray unit may be dangerous to both patient and operator unless safe exposure values are used and correct operating procedures are observed. CAUTION Modification of the X-ray unit is strictly prohibited. CAUTION Do not connect items which are not specified as part of the system. CAUTION Do not connect a multiple portable socket outlet (MPSO) or extension cord to the system. CAUTION If the X-ray unit shows any signs of oil leakage, disconnect the unit from mains and contact your service technician for help. CAUTION The X-ray unit is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. CAUTION Never use a defective or damaged X-ray unit. Contact your service technician for help. NOTE It is very important that the place where the X-ray unit is to be used and the position from which the user is to operate the unit are correctly shielded. Since radiation safety requirements vary from country to country and state to state it is the responsibility of the user to ensure that all local safety requirements are met. NOTE If the X-ray unit has been stored at temperatures below +10°C for more than a few hours, time must be allowed for the unit to reach room temperature before turning it on. NOTE Ensure efficient air conditioning in the X-ray room. It is recommended to keep the room temperature between +20°C and +25°C at all times.

CAUTION LBL-X-099

LASER RADIATION DO NOT STARE INTO BEAM 1mW CLASS II 635nm LASER PRODUCT

AVOID EXPOSURELaser radiation is emitted from this aperture. LBL-X-100

CLASS 1 LASER PRODUCT APPAREIL À LASER DE CLASSE 1 EN 60825-1/A2-2001

NOTE If the X-ray unit is not connected to an Uninterruptible Power Supply (UPS), disconnect the unit from mains during lightning storms. NOTE FOR US USERS: The patient positioning lights are class II laser products (21 CFR § 1040.10). NOTE FOR EUROPEAN USERS: Class 1 laser product (Standard EN 60825-1: 1994). The patient positioning lights are class 1, inherently safe laser lights. NOTE EMC requirements have to be considered, and the equipment must be installed and put into service according to the specific EMC information provided in the accompanying documents. NOTE Portable and mobile RF communications equipment can affect the Planmeca ProOne X-ray unit.

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WARNINGS AND PRECAUTIONS NOTE External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment). In addition, all such combinations - systems - shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems. Equipment not complying to IEC 60601 shall be kept outside the patient area (more than 2m (79 in.) from the X-ray unit). Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 606011-1. If in doubt, contact your service technician or local representative for help. NOTE Contact your service technician if you notice a decrease in image quality. NOTE Never place or hang any objects on any part of the Xray unit. NOTE Make sure that neither you nor your patient can get caught or hooked up on any part of the X-ray unit. Keep loose items of clothing, hair and jewellery tucked away safely. NOTE Do not attempt to remove any covers from the X-ray unit. X-ray unit covers may be removed by service personnel only. NOTE Do not touch the arm structures (C-arm, upper arm) when the X-ray unit is moving.

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MAIN PARTS

5

MAIN PARTS

5.1

General view of the system

Exposure switch

ProOne_013

X-ray unit

NOTE: PC MUST BE PLACED OUTSIDE PATIENT AREA

Patient area

2 79 m in.

Romexis/Dimaxis imaging software Ethernet

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MAIN PARTS

5.2

General view of the X-ray unit Upper arm C-arm

Temple supports Moving column Patient support Patient support table On/off switch (on the back of the column)

Emergency stop button

Patient handles

Control panel

ProOne_015

Stationary column

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MAIN PARTS

5.3

Exposure switch The exposure switch can be mounted on the wall, or it can be hung from the hook located on the back of the moving column if a protected area is within reach.

When the X-ray unit is ready to take an exposure a green indicator light will come on on the exposure button. Additionally, the status bar at the bottom of the control panel display will turn green.

Exposure indicator light AMBER = EXPOSURE

Exp_sw_wall6.eps

Exposure button with indicator light GREEN = READY

When you take an exposure an amber indicator light will come on on the exposure switch. It indicates that the Xray unit is generating radiation. Additionally, a radiation warning symbol will be shown on the control panel display and you will hear a radiation warning signal.

When you take an exposure you must press and hold down the exposure button for the whole duration of the exposure. If you remove your finger from the exposure button before the exposure cycle is completed radiation is interrupted, the C-arm will stop moving and a help message will appear on the control panel. The help message must be cleared before the X-ray unit can be used again.

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MAIN PARTS

5.4

Patient supports

TEMPLE?SUPPORTAI

Lip1.eps

Chin1.eps

Bite2.eps

Bite piece

Chin cup Chin2.eps

Chin support Temple supports Chin rest

5.5

Emergency stop button

The emergency stop button is located on the underside of the patient support table arm. Press the button to stop the X-ray unit operating in an emergency. When the emergency stop button is pressed down, all movements of the X-ray unit are blocked and the unit will not generate radiation.

ProOne_016

A help message will appear on the control panel display. Release the stop button to resume normal operation.

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Emergency stop button

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SWITCHING THE X-RAY UNIT ON

6

SWITCHING THE X-RAY UNIT ON

The on/off switch is located on the back of the moving column. When you switch the X-ray unit on the main display will be shown on the control panel and a blue light will come on on the left side of the display. Additionally, the X-ray unit will carry out a self-test which will last a few seconds.

ProOne_014

The X-ray unit is then ready for use. NOTE To prolong the lifetime of the Planmeca ProOne X-ray unit, always switch the X-ray unit off when it is not in active use.

On/off switch

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PROGRAM PACKAGES

7

PROGRAM PACKAGES The Planmeca ProOne X-ray unit offers a wide selection of exposure programs for various diagnostic purposes. The basic program package is included as standard and the other program packages are available as options. The basic program package includes basic panoramic, double TMJ and sinus programs for general maxillofacial diagnostics. The advanced program package consists of special panoramic, TMJ, sinus and cross sections programs for specific diagnostic needs. The panoramic bitewing program can be purchased as part of the advanced program package or separately. Each exposure program has a child setting which reduces the image size and patient dose. In the table the programs are divided according to the sales packages. In the following chapters the programs will be presented according to the program type.

Program package

Contents

Basic programs (standard)

•

Standard panoramic program

•

Double lateral TMJ program

•

Double PA TMJ program

•

PA rotational sinus program

•

Interproximal panoramic program

Advanced programs (optional)

10

•

Orthogonal panoramic program

•

Panoramic bitewing program

•

Double lateral-PA TMJ program

•

3 angles lateral TMJ program (left or right)

•

Lateral non-rotational sinus program (left or right)

•

Midsagittal non-rotational sinus program (left or right)

•

Cross sections manual

•

Cross sections automatic

Panoramic bitewing (optional)

•

Panoramic bitewing program

Segmenting (optional)

•

Horizontal and vertical segmenting for panoramic programs

DEC (optional)

•

Dynamic Exposure Control for panoramic programs

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CONTROL PANEL

8

CONTROL PANEL

8.1

General about control panel NOTE Never allow patients to touch the display while positioning them in the X-ray unit or carrying out the exposure. Touching the display during exposure will interrupt radiation, stop the C-arm movement, and cause a help message to appear on the control panel. The help message must be cleared before the X-ray unit can be used again. NOTE The contents of the displays depend on the configuration of the X-ray unit. The displays shown here are from an X-ray unit that features all currently available imaging programs and functions. To make a selection on the control panel, simply touch the display with your finger or a soft stylus on a text field or on an icon. For example, to select a program touch the program field. You will hear a signal tone when a field is activated. NOTE Do not use sharp objects to operate the control panel. Only the text fields and icons on the display are touchsensitive, and touching areas outside them will not activate an action. To accept a selection, touch the green check mark button in the bottom right corner of the display. To cancel a selection, touch the red cross button in the bottom left corner of the display. Cross = Cancel

Check mark = Accept The display will automatically switch to stand-by mode if you do not touch the display or the exposure button for more than 30 minutes. A blue power light on the left side of the display indicates that the X-ray unit is switched on even though the display is dark. The display will switch on as soon as you touch it again.

DAP value You can set the X-ray unit so that the current time and/or date will be shown at the bottom of the display. You can choose in which format (e.g. 22.10.2008 for date and 13:49 for time) they will be shown. Refer to section “Setting time and date (U1100)” on page 37 for more information.

Time & date

User’s Manual

You can set the X-ray unit so that the estimated DAP (Dose Area Product) value will be shown on the main display for the exposure you are going to take. The DAP value indicates the highest radiation dose the patient will be exposed to during the exposure. Refer to section “Program presets (P2200)” on page 46 for more information.

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CONTROL PANEL You can set the X-ray unit so that a preview of the image will be shown on the control panel after exposure. This option allows you to evaluate the image immediately after you have taken it. Refer to section “Functions after exposure (P2300)” on page 48 for more information. NOTE The control panel can be adjusted to respond to your individual finger touch. Refer to section “Operational settings (U1300)” on page 39 for more information. NOTE You can switch practice mode on, if you wish to practice or demonstrate the functions of the X-ray unit without radiation. Refer to section “Operational settings (U1300)” on page 39 for more information.

8.2

Selecting panoramic exposure program

Program field

To select a panoramic exposure program touch the program field on the main display. The main display is the display that is shown when the X-ray unit is switched on.

The Select program display appears. Select the required panoramic exposure program by touching the appropriate field on the display. The selected program will be highlighted. NOTE The patient positioning lights will be automatically switched on when you select the exposure program.

There are four panoramic exposure programs: Standard, Interproximal, Orthogonal and Bitewing. NOTE The panoramic program “Standard” is included in the basic program package. Other panoramic programs are optional. NOTE When the child setting (smallest patient size) is selected, the image size and patient dose are automatically reduced.

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CONTROL PANEL

Standard panoramic program Direction of beam

The Standard panoramic program has a traditional path and angles of the beam. Image size for adult setting

1 cm

layer laser beam

Interproximal panoramic program Direction of beam

Image size for child setting

In the Interproximal program the basic imaging geometry is the same as in the standard panoramic program but the angle of the X-ray beam is more parallel to the interproximal contacts of the teeth. This program is used for caries detection. Image size for adult setting

1 cm

layer laser beam

Image size for child setting

Orthogonal panoramic program NOTE This program is optimized for interproximal imaging Direction of beam and a shadow of the opposite side teeth may therefore be visible in the radiograph.

In the Orthogonal program the basic imaging geometry is the same as in the standard panoramic program but the angle of the X-ray beam is more perpendicular to the jaw. 1 cm

User’s Manual

layer laser beam

This program is useful for periodontal studies.

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CONTROL PANEL

Image size for adult setting

Image size for child setting

NOTE This program is optimized for orthogonal imaging and a shadow of the opposite side teeth may therefore be visible in the radiograph.

The Bitewing program produces bitewing-like images from premolar and molar areas including parts of maxilla, mandible and rami. The bottom of the maxillary sinus as well as the mandibular canal and the mental foramen are also visible.

Bitewing Direction of beam

The bitewing program uses improved interproximal angulation projection geometry. Image size for adult setting

layer laser beam

Image size for child setting NOTE This program is optimized for interproximal imaging and a shadow of the opposite side teeth may therefore be visible in the radiograph.

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CONTROL PANEL Accept the selection and return to the main display by touching the green check mark button in the bottom right corner of the display.

Cancel

Accept

Image sizes in panoramic programs

Program

Patient size

Real image size (WxH) mm

Image size on receptor (WxH) mm

Magnification

Standard panoramic Interproximal panoramic Orthogonal panoramic Panoramic bitewing

User’s Manual

Adult

226 x 103

288 x 134

1.27

Child

176 x 88

223 x 112

1.27

Adult

115 x 48

146 x 60

1.27

Child

74 x 40

93 x 50

1.27

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CONTROL PANEL 8.2.1

Selecting exposure area for panoramic exposures (optional) NOTE Segmenting is an optional feature. Refer to section “Program licences (P2100)” on page 44 for more information. This optional segmenting function allows you to take panoramic exposures of different jaw segments. It will reduce the radiation dose as only diagnostically interesting areas need to be X-rayed. Touch the exposure area field on the main display.

Exposure area field

The Select exposure area display appears. The display shows an image which is divided into two horizontal and five vertical segments.

Deselected segments no exposure

Touch the corresponding arrow button(s) to deselect the segment(s) that should not be exposed. The segments which will not be exposed are shown faded. The segments which will be exposed are shown in full colour. Touching the arrow of a deselected segment again will change the colour of the segment back to normal.

Segments to be exposed

Cancel

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NOTE The image shown on the display is only an example. The exposed image will not equal the example image.

Accept

Accept the selections you have made, and return to the main display by touching the green check mark button in the bottom right corner of the display.

User’s Manual

CONTROL PANEL With the optional Panoramic bitewing program you can deselect right or left side by touching the corresponding arrow button on the control panel.

Patient’s right

Cancel

8.3

Patient’s left

Accept

Accept your selection and return to the main display by touching the green check mark button in the bottom right corner of the display.

Selecting temporomandibular joint (TMJ) exposure program

Program field

To select a temporomandibular joint (TMJ) exposure program touch the program field on the main display. The main display is the display that is shown when the X-ray unit is switched on.

The Select program display appears. Select the required TMJ exposure program by touching the appropriate field on the display. The selected program will be highlighted.

NOTE The patient positioning lights will be automatically switched on when you select the exposure program.

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