ProOne User Manual Rev 9 Release June 2011

Page 1

EN

user's manual

10016256_9

Page 2

PLANMECA OY Asentajankatu 6, 00880 Helsinki, Finland, tel. +358 20 7795 500

fax +358 20 7795 555, e-mail: sales@planmeca.com, www.planmeca.com

Page 4

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

Page 5

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.

User’s Manual

Planmeca ProOne 1

Page 6

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

2

Planmeca ProOne

User’s Manual

Page 7

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.

User’s Manual

Planmeca ProOne 3

Page 8

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.

4

Planmeca ProOne

User’s Manual

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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

User’s Manual

Planmeca ProOne 5

Page 10

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

6

Planmeca ProOne

User’s Manual

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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.

User’s Manual

Planmeca ProOne 7

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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.

8

Emergency stop button

Planmeca ProOne

User’s Manual

Page 13

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

User’s Manual

Planmeca ProOne 9

Page 14

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

Planmeca ProOne

User’s Manual

Page 15

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.

Planmeca ProOne 11

Page 16

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.

12

Planmeca ProOne

User’s Manual

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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.

Planmeca ProOne 13

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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.

14

Planmeca ProOne

User’s Manual

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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

Planmeca ProOne 15

Page 20

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

16

Planmeca ProOne

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

Page 21

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.

User’s Manual

Planmeca ProOne 17

Page 22

CONTROL PANEL

There are four TMJ exposure programs: Double lateral,

Double PA, Double lateral-PA and 3 angles lateral.

NOTE The temporomandibular programs “Double lateral”

and “Double PA” are included in the basic program

package and enabled by default. However, the “Double

PA” program could have been disabled by the service

personnel. The “Double lateral-PA” and “3 angles

lateral” programs are optional.

NOTE When the child setting (smallest patient size) is

selected, the image size and patient dose are

automatically reduced.

Double lateral

Double lateral:

Lateral TMJ exposures of open and closed

temporomandibular joints. The imaging angle is

adjustable (factory default angle: 17°).

1 cm

2.

Double PA

1 cm

18

Planmeca ProOne

4.

3.

1.

Double PA:

Posteroanterior TMJ exposures of open and closed

temporomandibular joints. The imaging angle is 60° and it

is not adjustable.

2.

4.

3.

1.

User’s Manual

Page 23

CONTROL PANEL

Double lateral-PA

Double lateral-PA:

Lateral and posteroanterior TMJ exposures of open or

closed temporomandibular joints.

The imaging angle for the lateral exposure is adjustable

(factory default angle: 17°). The imaging angle for the

postero-anterior exposure is 60° and it is not adjustable.

1 cm

2.

4.

3.

1.

3 angles lateral:

Three lateral multi-angle left-hand or right-hand side TMJ

exposures.

3 angles lateral, left

123

The imaging angle for image no. 2 is adjustable (three

imaging angles: factory default angle 17° ±7°). The

selected imaging angle is in image no. 2

1 cm

First exposure = Selected angle - 7°

3.

2.

1.

Second exposure = Angle selected by user

(factory default angle: 17°)

Third exposure = Selected angle + 7°

User’s Manual

Accept the selection and return to the main display by

touching the green check mark button in the bottom right

corner of the display.

Planmeca ProOne 19

Page 24

CONTROL PANEL

8.3.1

Selecting imaging position for temporomandibular joint (TMJ) exposures

Touch the image position field in the middle of the display

to select the imaging position.

The X-ray image in the top right corner of the field shows

in which order the images will appear on the radiograph.

The active exposure is shown in full colour. The number in

the top left corner indicates the number of the active

exposure.

Image

position

field

Target

position

Imaging

angle

arrows

(lateral

exposures)

Symmetric/

asymmetric

setting

On the display that appears you can adjust the imaging

position by touching the target position arrows in the

bottom right corner. The arrow pointing to the left will

move the target position forwards and the arrow pointing

to the right will move the target position backwards. The

target position on the other jaw side will move accordingly

if the icon for symmetric/asymmetric setting shows an

undivided jaw (one line in the middle). The number that is

shown on the display demonstrates the position of the

layer light and serves as a reference for later retakes.

NOTE The imaging position can also be adjusted by touching

the target position arrows on the main TMJ display.

Target position arrows

Symmetric/

asymmetric

setting

20

Planmeca ProOne

The imaging angle can be adjusted for lateral TMJ

exposures. The default imaging angle for lateral

exposures can be defined by user in the Program presets

menu, option Lateral TMJ default angle, see Section

“Program presets (P2200)” starting from page 46. To

adjust the imaging angle for the exposure you are going to

take touch the imaging angle arrows next to the degree

marking. Touching the upwards pointing arrow will

decrease the angle and touching the downwards pointing

arrow will increase the angle. The imaging angle on the

other jaw side will change accordingly if the icon for

symmetric/asymmetric setting shows an undivided jaw

(one line in the middle).

If the patient’s right and left side are asymmetric you will

need to set the target position and imaging angle (lateral

views) separately on the other side. To do this, touch the

icon for symmetric/asymmetric setting to select the

asymmetric setting and adjust the other side as required.

In the asymmetric setting the icon shows a divided jaw

(two lines in the middle).

User’s Manual

Page 25

CONTROL PANEL

NOTE In the asymmetric setting, touching the target position

arrows on the main TMJ display will adjust the imaging

position only on the patient’s left side.

The right/left buttons at the top of the display allow you to

select on which side the exposures will be taken. You can

set the unit to take TMJ exposures on one side or on both

sides. The button(s) of the selected side(s) will be

highlighted. Note that the buttons refer to the patient’s

(not your) right and left side.

Patient’s

right/left

side

NOTE In multi-angle exposures the selected imaging angle is

in image no. 2.

3 angles lateral, left

123

3.

2.

1.

Imaging angle selected by the user

1 cm

First exposure = Selected angle - 7°

Second exposure = Angle selected by the user

(factory default angle: 17°)

Third exposure = Selected angle + 7°

Accept the selection and return to the main display by

touching the green check mark button in the bottom right

corner of the display.

User’s Manual

Planmeca ProOne 21