User Manual

Digital Panoramic X-ray Unit

REF DP300UMEW ver 1

206259 rev 1

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 Documentation for Gendex GXDP-300TM and the operating software are copyrighted
with all rights reserved. Under the copyright laws, this 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
Gendex Dental Systems.
Gendex® and Gendex GXDP-300TM are registered trademarks of Gendex Dental
Systems

Language
The original language of this manual is English.

Manufactured for:
Gendex Imaging Systems
1910 North Penn Road
Hatfield, Pa 19440.

Manufacturer:
PaloDEx Group Oy
Nahkelantie 160,
P.O.Box 64,
FI-04301 Tuusula, Finland
Tel. +358 10 270 2000
Fax +358 9 851 4048

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 GXDP-300® Contents

Contents
1. Introduction ....................................................................................................... 1
1.1 GXDP-300® X-ray unit ................................................................................... 1
1.2 About this manual .......................................................................................... 1
1.3 Setup properties ............................................................................................ 1
2. Unit description ................................................................................................. 2
2.1 Main parts ..................................................................................................... 2
2.2 Unit controls .................................................................................................. 4
2.3 Accessories ................................................................................................... 5
3. Using the Unit .................................................................................................... 6
3.1 Preparing the Unit ......................................................................................... 6
3.2 Taking Exposures .......................................................................................... 7
Panoramic adult, child and bitewing ........................................................... 7
Temporomandibular Joint (TMJ) ............................................................... 15
4. Operating the unit without x-rays .................................................................. 21
5. Troubleshooting and Maintenance ................................................................ 22
5.1 Error messages and symbols ...................................................................... 22
Error symbols............................................................................................ 23
User errors ................................................................................................ 23
System errors ........................................................................................... 24
5.2 Care and Maintenance ............................................................................... 25
Cleaning and disinfecting the unit ............................................................. 25
Surfaces that the patient touches ..................................................... 25
Unit surfaces .................................................................................... 25
Positioning mirror and laser cover .................................................... 25
Touch screen control panel .............................................................. 25
Correct operation of the unit ..................................................................... 26
Yearly maintenance .................................................................................. 26
6. Warnings and precautions ............................................................................. 27
6.1 General warnings ........................................................................................ 27
6.2 User / patient warnings ............................................................................... 28
7. Disposal............................................................................................................ 30
Appendix A. Technical Information...................................................................... 1
A.1 Technical specifications ................................................................................ 1
A.2 Unit dimensions ............................................................................................ 8
A.3 Symbols that appear on the unit ................................................................... 9
A.4 EMC declaration ..........................................................................................11

User Manual v

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 Contents GXDP-300®

vi User Manual

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 GXDP-300® 1. Introduction

1. Introduction
1.1 GXDP-300® X-ray unit
The GXDP-300® (the unit) is a digital panoramic
dental x-ray unit designed to take:
- panoramic exposures of large, medium and
small patients (with small exposures the width is
reduced),

- bitewing exposures

- and lateral temporomandibular joint exposures.

The unit uses a CCD sensor as the image receptor
and a PC with suitable (MDD approved) dental im-
aging software for image acquisition and handling.

USA only
Caution:
Federal law restricts this device to sale by or on the
order of a dentist or other qualified professional.

1.2 About this manual

This manual describes how to use the unit.

Please read these instructions carefully before op-

erating the unit.

Before operating this unit, read and familiarizes

yourself with the warnings and precautions that ap-
pear in section
6. Warnings and Precautions.

1.3 Setup properties

There are numerous setup properties in the GxPic-
ture Driver Suite software that allow you to set the
operation of the unit and the image quality to your
requirements. Refer to the documentation supplied
with the GxPicture Software Driver for more infor-
mation.

User Manual 1

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 2. Unit description GXDP-300®

2. Unit description
2.1 Main parts

1 Column
2 Motorized carriage
3 Rotating unit
4 Exposure warning lights
5 Emergency stop button - Press to stop, rotate to release.
6 On / off switch (rear of column)
7 PC (NOT SUPPLIED) with MDD approved dental imaging software

2 User Manual

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 GXDP-300® 2. Unit description

1 Head support
2 Midsagittal laser
3 Mirror
4 Frankfort laser and laser positioning knob
5 Cuspid positioning knob
6 Chin rest
7 Cuspid laser
8 Patient handgrips

User Manual 3

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 2. Unit description GXDP-300®

2.2 Unit controls

A. Side control panel

1 Lasers key - switches the patient positioning lasers on and off
2 Up key - drives the unit up
3 Down key - drives the unit down
4 Return key - drives the unit to the patient entry position

B. Main control panel

5 Program selection keys - panoramic, bitewing, temporomandibular joint
6 Patient size selection keys - large, medium and small
7 Ready indicator light:
- green, unit ready for an exposure
- red, unit is cooling down after an exposure
8 No x-rays key - the unit can be operated without generating x-rays
9 Exposure values
10 Service key

4 User Manual

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 GXDP-300® 2. Unit description

2.3 Accessories
Chin rest

Bite guide

Bite rod 71 mm

Chin support

Partial edentulous bite positioner

Nose support long - for small adults and children

Nose support short - for large and medium adults

Boxes of hygienic barriers for:

- bite guide

- chin rest and chin support

- temple supports

For the partial edentulous bite positioner and the

nose supports use a piece cut from a temple sup-
port hygienic barrier.

User Manual 5

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 3. Taking an Exposure GXDP-300®

3. Using the Unit

IMPORTANT NOTE:
If the unit is being used for the first time or if you are
using the unit for the first time, check that it is set up
to your requirements. Refer to the documentation
supplied with the GxPicture Software Driver for
more information.

3.1 Preparing the Unit

1. PC: Switch on the acquisition PC or network
switch/PC that is connected to the unit.

2. Switch the unit on. The on/off switch is at the

base of the column at the rear.
The unit display will come on and the unit will
carry out a self test. When the Ready light turns
GREEN the unit is ready to take an exposure.

3. Press the Return key to drive the rotating unit

to the patient entry position.

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 GXDP-300® 3. Taking an Exposure

3.2 Taking Exposures

Panoramic adult, child and bitewing
1. Slide the chin rest on to the support holder.

2. Dentate patients. Attach the bite guide to the

bite rod and then insert the bite rod and bite
guide into the hole in the chin rest.

Edentulous patients. Attach the chin support to

the chin rest.
Partially edentulous patients. Attach the par-
tially edentulous bite positioner to a bite rod
and then insert the bite rod and edentulous bite
positioner into the hole in the chin rest.

User Manual 7

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 3. Taking an Exposure GXDP-300®

3. Place the appropriate hygienic barrier on to the

patient support you are using.

Pan B/W
4. Select the panoramic program you require,
panoramic (Pan) or bitewing (B/W).
The magnification for these programs is 1.25.

5. Select the patient size, large, medium or small.

Large Medium Small

73 kV 70 kV 63 kV

The exposure and DAP values will appear on

the display.

NOTE:
If you select small panoramic the width of the
image will be reduced.

6. Ask the patient to remove any eye glasses, den-

tures, jewellery, hair clips and pins.
Place a protective lead apron over the patient’s
shoulders.

NOTE:
If the patient is nervous about the exposure pro-
cedure you can reassure them by demonstrating
how the unit works before taking the exposure.
See section 4. Operating the unit without x-
rays.

8 User Manual

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 GXDP-300® 3. Taking an Exposure

7. Press the Up/Down keys to adjust the height of

the chin rest so it is slightly higher than the pa-
tient’s chin so that the patient will have to stretch
up to place their chin on the chin rest.

8. If the patient is dentate, ask the patient to step

into the unit, grasp the patient handgrips, place
his/her chin on the chin rest and bite the notches
in the bite guide.

If the patient is partially edentulous, ask the pa-

tient to bite the partial edentulous bite positioner.

If the patient is edentulous, ask the patient to

press their chin against the chin support.

9. Press the Lasers key to switch the patient po-

sitioning lasers on. They will remain on for two
minutes.
NOTE:
The patient positioning lasers will automatically
come on when either the Up or Down key is
pressed.

User Manual 9

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 3. Taking an Exposure GXDP-300®

10. Look at the reflection of the patient in the mir-

ror and position the midsagittal plane of the
patient so that it coincides with the midsagittal
plane laser.

Make sure that the patient is looking straight

ahead and that the patient’s head is not tilted or
turned to one side.

Correct

Incorrect

11. Press either Up/Down key to adjust the tilt of

the patient’s head so that it is in the correct posi-
tion for the exposure you are taking.

For a panoramic exposure position the patient’s

Frankfort plane so that it coincides with, or is
parallel to the horizontal laser.

For a bitewing exposure position the patient’s

Occlusal plane so that it coincides with, or is
parallel to the horizontal laser.

Panoramic Bitewing

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 GXDP-300® 3. Taking an Exposure

CAUTION:
When pressing the Up/Down keys to adjust the
tilt of the patient’s head take care not to cause
the patient any distress or discomfort.

12. The cuspid laser indicates the center of the focal

trough which is 10 mm wide at the front.
Ask the patient to open their lips so that you can
see the patient’s teeth.
For panoramic exposures use the cuspid posi-
tioning knob to position the patient so that the
cuspid laser is in the center of the patient’s up-
per and lower cuspids.

For bitewing exposures position the chinrest on

the BW line.

User Manual 11

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 3. Taking an Exposure GXDP-300®

13. Carefully push the head support towards the

patient (A). Make sure that patient’s neck is
stretched and straight.
Rotate the head support knob (B) clockwise to
close the temple supports so that they gently but
firmly grip the patient’s head.

14. Ask the patient to press their lips together and

press their tongue against the roof of their
mouth.
Then ask the patient to look at a fixed point in
the mirror and to remain still for the duration of
the exposure.
The exposure takes approximately 12 seconds
for a panoramic exposure and six seconds for a
bitewing.

15. Ask the patient to step forward slightly so that

he/she is out of balance and “hanging” onto the
patient handgrips. This will force the patient to
stretch their neck as far a possible.
Check that the patient has not moved and is still
in the correct position.

16. Move at least two metres away from the unit and
protect yourself from radiation.
Make sure that you can see and hear the patient
during the exposure.

12 User Manual

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 GXDP-300® 3. Taking an Exposure

17. Press and hold down the exposure button for

the duration of the exposure. During the ex-
posure you will hear an audible signal and the
exposure warning lights will come on. The ro-
tating unit will rotate around the patient’s head
and then stop. When the rotating unit stops, the
exposure has been taken and you can release
the exposure button.

19. Turn the head support knob (B) counterclock-

wise to open the temple supports. Press the
release button (C) at the top of the head support
and then slide the head support away from the
patient (A).
Guide the patient out of the unit.

User Manual 13

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 3. Taking an Exposure GXDP-300®

20. Press the Return key to drive the unit to the

patient entry position.
NOTE:
After the exposure, a timer indicating the tube-
head cooling time will appear on the display. A
new exposure cannot be taken until the counter
reaches zero, the exposure time reappears on
the display, and the ready light comes on.

21. PC: After the exposure has been taken a pro-

gress bar will appear. This indicates that the
image is being transferred to the PC.

14 User Manual

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 GXDP-300® 3. Taking an Exposure

Temporomandibular Joint (TMJ)

1. Slide the nose support into the support holder.
Use the short version for large and medium
adults and the long version for small adults and
children.

2. Place a piece of hygienic barrier cut from the

chin or temple supports hygienic barrier on to
the nose support.

TMJ
3. Select the temporomandibular joint (TMJ) pro-
gram.
The magnification is 1.25.

4. Select the patient, large, medium or small.

Large Medium Small

73 kV 70 kV 63 kV

5. Use the cuspid positioning knob and position the

support holder so that it is -5 for a large or me-
dium patient and 0 for a small patient.

User Manual 15

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 3. Taking an Exposure GXDP-300®

6. Ask the patient to remove any eye glasses, false

teeth, jewellery and hair clips and pins. Place a
protective lead apron over the patient’s shoul-
ders.
NOTE:
If the patient is nervous about the exposure pro-
cedure you can reassure them by demonstrating
how the unit works before taking the exposure.
See section 4. Operating the unit without x-
rays.

7. Press the Up/Down keys to adjust the height of

the nose support so that the top is level with the
patient’s upper lip.

8. If you are taking a TMJ exposure with the pa-

tient’s mouth closed, ask the patient to clench
their back teeth together, step into the unit,
grasp the patient handgrips and press their top
lip against the top of the nose support.

If you are taking a TMJ exposure with the pa-

tient’s mouth open, ask the patient to open
their mouth, step into the unit, grasp the patient
handgrips and press their top lip against the top
of the nose support.

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 GXDP-300® 3. Taking an Exposure

9. Press the Lasers key to switch the patient po-

sitioning lasers on. They will remain on for two
minutes.
NOTE:
The patient positioning lasers will automatically
come on when either the Up or Down key is
pressed.

10. Look at the reflection of the patient in the mir-

ror and position the midsagittal plane of the
patient so that it coincides with the midsagittal
plane laser.
Make sure that the patient is looking straight
ahead and that the patient’s head is not tilted or
turned to one side.

11. Press either Up/Down key to adjust the tilt of

the patient’s head until the patient’s Frankfort
plane coincides with, or is parallel to, the hori-
zontal laser.

CAUTION:
When pressing the Up/Down keys to adjust the
tilt of the patient’s head take care not to cause
the patient any distress or discomfort.

User Manual 17

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 3. Taking an Exposure GXDP-300®

12. Carefully push the head support towards the

patient (A). Make sure that patient’s neck is
stretched and straight.
Rotate the head support knob (B) clockwise to
close the temple supports so that they gently but
firmly grip the patient’s head.

13. Check once more that the patient is positioned

correctly and has not moved.

14. Ask the patient to look at a fixed point in the

mirror and to remain still for the duration of the
exposure.
The exposure takes approximately 12 seconds.

15. Move at least two metres from the unit and pro-
tect yourself from radiation. Make sure that you
can see and hear the patient during the expo-
sure.

18 User Manual

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 GXDP-300® 3. Taking an Exposure

16. Press and hold down the exposure button for

the duration of the exposure. During the ex-
posure you will hear an audible signal and the
exposure warning lights will come on. The ro-
tating unit will rotate around the patient’s head
and then stop. When the rotating unit stops, the
exposure has been taken and you can release
the exposure button.

17. PC: After the exposure has been taken a pro-

gress bar will appear. This indicates that the
image is being transferred to the PC.

18. If you wish to take a second TMJ exposure,

press the Return key to drive the unit back to
the patient entry position, reposition the patient
and take then the second exposure following
steps 13 - 16 described previously.

User Manual 19

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 3. Taking an Exposure GXDP-300®

19. Turn the head support knob (B) counterclock-

wise to open the temple supports. Press the
release button (C) at the top of the head support
and then slide the head support away from the
patient (A).
Guide the patient out of the unit.

20. Press the Return key to drive the unit to the

patient entry position.

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 GXDP-300® 4. Operating the unit without x-rays

4. Operating the unit without x-rays

In some situations, for example with nervous pa-
tients or patients with unusual anatomy, you may
wish to operate the unit without generating x-rays
before taking an exposure.

Press the no x-rays key. The key will change color

and the other keys will gray out. The exposure
switch can now be pressed to demonstrate how the
unit operates without x-rays being generated.

Press the no x-rays key a second time to return to

the normal exposure mode.

NOTE:
After switching the unit off and then on again the
unit returns to the normal x-ray mode.

User Manual 21

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 5. Troubleshooting and Maintenance GXDP-300®

5. Troubleshooting and Maintenance

5.1 Error messages and symbols
If the unit is not used correctly or the unit malfunc-
tions an error message or symbol will appear on the
unit display.

There are three groups of error message:

- Error symbols
The symbol will clear when the problem is cor-
rected.

- H, user errors

- E (Error), exposure errors, these occur during

exposure.
These appear on the error message display.
Touch the CLEAR button to clear the error mes-
sage and return to the main display.
NOTE:
If the CLEAR button does not appear on the er-
ror message display you will have to wait for the
error to clear automatically.

22 User Manual

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 GXDP-300® 5. Troubleshooting and Maintenance

Error symbols

REASON
i. The PC connected to the unit is not on.
ii. GxPicture in the PC is not open.
iii. The cable connecting the unit to the PC is disconnected or damaged.
iv. The IP address is not set correctly.

SOLUTION
i. Switch the PC on.
ii. Open GxStart.
iii. Reconnect the cable. If damaged, contact service.
iv. Reconfigure the IP address.

REASON
The emergency stop button is pressed down in the STOP position.

SOLUTION
Rotate and release the emergency stop button. The error symbol will clear.

User errors
H1
REASON
The exposure button was released during an exposure.

SOLUTION
Clear the error message and check if the attempted exposure is sufficient for the
diagnostic task. If it is not, take a new exposure.
If the exposure failed while the exposure button was still being pressed, check the
exposure switch by taking a test exposure without patient to see if the exposure
button is defective or not. If the same problem occurs again, contact service.

User Manual 23

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 5. Troubleshooting and Maintenance GXDP-300®

System errors
E4
REASON
Tubehead too hot or too cold.

SOLUTION
When the error message automatically clears the tubehead has reached the cor-
rect operating temperature. In normal conditions this will take about 30 minutes
for the tubehead to reach the correct temperature. If the error message does not
disappear within a reasonable amount of time, contact service.

E5
REASON
Line voltage not within limits.

SOLUTION
If the error message reappears it indicates that the voltage is not within limits. The
error message will automatically clear when the voltage returns to the correct level.
If the error message keeps on appearing or does not disappear within a reason-
able amount of time, contact service.

E19
REASON
Exposure switch stuck down during unit start.

SOLUTION
Switch the unit off and check that the exposure switch is not stuck in the exposure
position. Switch the unit on again. If the message reappears, contact service.

Exx (all other E errors except E4, E5 and E19 (above).

SOLUTION
Clear the error message and try to take an exposure without a patient. If the error
message reappears, switch the unit off, wait for half a minute and then switch the
unit on again. If the error message reappears contact service.

24 User Manual

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 GXDP-300® 5. Troubleshooting and Maintenance

5.2 Care and Maintenance

Cleaning and disinfecting the unit
Warning
Switch the unit off before cleaning it.

Surfaces that the patient touches

All surfaces and parts that the patient touches or
comes into contact with must be disinfected after
each patient. Use a disinfectant that is formulated
specifically for disinfecting dental equipment and
use the disinfectant in accordance with the manu-
facturer’s instructions.
Unit surfaces
Use a soft cloth dampened with a mild detergent/
disinfectant to clean unit surface. DO NOT use
abrasive cleaning agents or polishes on the unit.

Positioning mirror and laser cover

The positioning mirror is made of glass and the cus-
pid laser cover is made of plastic. Use a soft cloth
dampened with a mild detergent to clean them. DO
NOT use abrasive cleaning agents or polishes on
these parts.

Touch screen control panel

If the surface of the control panel becomes soiled,
clean it with absorbent cotton or other soft cloth.
Remove any drops of liquid from the control panel
surface immediately. Prolonged contact with liquid
may cause the surface of the control panel to dis-
color or spots to appear.

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 5. Troubleshooting and Maintenance GXDP-300®

Correct operation of the unit

If any of the unit’s controls, displays or functions fail
to operate or do not operate in the way described in
this manual, switch the unit off, wait 30 seconds and
then switch the unit on again. If the unit still does
not operate correctly contact your service technician
for help.

If you hear the exposure warning tone but the expo-

sure warning light on the display does not come on
when an exposure is taken, stop using the unit and
contact your service technician for help.

If you do not hear the exposure warning tone when

an exposure is taken, stop using the unit and con-
tact your service technician for help.

Every week check that the power supply cable is in

good order (not damaged in any way) and that the
unit operates correctly in accordance with the in-
structions in this manual.
Make sure that the unit cannot be driven up/down
when the emergency stop button has been pressed
down.

Yearly maintenance
Once a year an authorized service technician must
carry out a full inspection of the unit. During the
inspection the following tests will be carried out:
– a kV/mA test
– a beam alignment test
– a check that the safety ground is connected
– a check that the positioning lights operate
– a check that oil is not leaking from the tube head
– a check that all covers and mechanical parts are
correctly secured and have not come loose.
A full description of all the tests and checks is de-
scribed in the Service Manual.

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 GXDP-300® 6. Warnings and precautions

6. Warnings and precautions

6.1 General warnings
• The unit must only be used to take the dental
x-ray exposures described in this manual. The
unit must NOT be used to take any other x-ray
exposures.
It is not safe to use the unit to take an x-ray ex-
posure that the unit is not designed to take.

• If this device will be used with 3rd party imag-

ing application software not supplied by Gendex
Dental Systems (Gendex), the 3rd party imag-
ing application software must comply with all
local laws on patient information software. This
includes, for example, the Medical Device Direc-
tive 93/42/EEC and/or FDA if applicable.

• Do not connect any device to the unit that has

not been supplied with the unit or that is not rec-
ommended by Gendex Dental Systems (Gen-
dex).

• The unit or its parts must not be changed or

modified in any way without approval and in-
structions from Gendex Dental Systems (Gen-
dex).

• The unit should not be used adjacent to or

stacked with other equipment.

• This unit can interfere with other devices due to

its EMC characteristics and other devices can
interfere with this unit due to their EMC charac-
teristics. Refer to the EMC Declaration (A4) in
Appendix A for more information.

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 6. Warnings and precautions GXDP-300®

6.2 User / patient warnings

• The unit may be dangerous to the user and the
patient, if the safety regulations in this manual
are ignored, if the unit is not used in the way
described in this manual and/or if the user does
not know how to use the unit.

• Because the x-ray limitations and safety regula-

tions change from time to time, it is the respon-
sibility of the user to make sure that all the valid
safety regulations are fulfilled.

• It is the responsibility of the user to decide if the

x-ray exposure is necessary.

• Always use the lowest suitable x-ray dose to

obtain the desired level of image quality.

• Always use suitable hygienic barriers on parts of

the unit that the patient has contact with.

• Avoid taking x-ray exposures of pregnant wom-

en.

• If the patient is using a pacemaker, consult the

manufacturer of the pacemaker to confirm that
the x-ray unit will not interfere with the operation
of the pacemaker before taking an exposure.

• The user of the unit must stand at least two

meters away from the unit AND protect him/her-
self from radiation when taking exposures. It is
recommended that a moveable radiation protec-
tion screen is used to protect the user.

• The user must be able to see and hear the pa-

tient during an exposure.

• The user must see the exposure warning light

and/or hear the audio exposure warning signal
during the exposure. If the unit is installed in
such a place where the exposure warning light
cannot be seen, a separate exposure warning
light should be used. Please contact your local
service for help.

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 GXDP-300® 6. Warnings and precautions

• Disinfect all the surfaces that the patient is in

contact with after every patient.

• If the unit does not appear to be working cor-

rectly, switch the unit off and release the patient.
Make sure that the unit operates correctly before
you continue using it. If you are not sure wheth-
er the unit is operating correctly, please contact
your local service for help.

• If the unit will not be used for a long time, switch

the unit off in order to prevent unauthorized peo-
ple using the unit.

• Do not use the unit if any of its covers or parts

are damaged, loose or have been removed.
Contact a service person approved by Gendex
Dental Systems (Gendex) and get them to repair
or replace any damaged, loose or removed cov-
ers or parts before reusing the unit.

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 7. Disposal GXDP-300®

7. Disposal
At the end of useful service life of the device, its
spare parts, its replacement parts and its acces-
sories 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 accesso-
ries.

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 dis-
posed of in accordance with all local, national and
international regulations regarding the disposal of
non-environmentally friendly or hazardous materi-
als.

Hazardous materials and parts that are made of or

contain these materials:
LEAD:
Tubehead housing, collimator, CCD sensor,
circuit boards.

TUBEHEAD OIL
Inside tubehead

CESIUM IODIDE (CsI)

CCD sensor
For more information on these parts contact your
dealer.

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 GXDP-300® 7. Disposal

User Manual 31

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 GXDP-300 Appendix A. Technical Information

Appendix A. Technical Information

A.1 Technical specifications
Type
GXDP-300

Classification
Complies with IEC 60601-1/1995, IEC 60601-2-7/1998, IEC 60601-2-28/1993 and
IEC 60601-2-32/1994, IEC 878
UL 2601-11/2006 (for products with the UL Classification Mark) and EN 55011
standards
Conforms with the regulations of DHHS Radiation Performance Standard, 21CFR
Subchapter J.
Safety according to IEC 60601-1
Protection against electric shock - Class 1
Degree of protection - Type B applied with no conductive connection to the patient
Protection against the ingress of liquids - IPX 0
Disinfection methods:
- mild soapy water (non-abrasive)
- non-alcohol based disinfectant for the chin rest
- disposable plastic covers for bite guide, chin rest and lip support
For use in environments where no flammable anaesthetics nor flammable cleaning
agents are present
Mode of operation - continuous operation/intermittent loading

Unit description
A dental panoramic x-ray units with a high frequency switching mode x-ray
generator. The unit takes panoramic exposures.
The unit uses a CCD sensor as an image receptor.

Generator
TUBE
Toshiba D-052 SB or D-054 SB or CEI 105/5 or equavalent
TUBEHEAD HOUSING ASSEMBLY
THA-M-3
FOCAL SPOT
0.5 mm (IEC 60336/1993)
FOCAL SPOT ACCURACY
The accuracy is 10mm from the marking on the tubehead cover
TARGET ANGLE
5º

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 Appendix A. Technical Information GXDP-300

TARGET MATERIAL
Tungsten
NOMINAL X-RAY TUBE VOLTAGE
66, 70, and 73 kV ±4 kV @ 8 mA
NOMINAL X-RAY TUBE CURRENT
8 mA ±1 mA @ 73 kV
NOMINAL ANODE INPUT POWER
584 W nominal @ 73 kV, 8 mA, 12 s
MAXIMUM TUBE CURRENT
8 mA @ 73 kVs
MAXIMUM ANODE OUTPUT POWER
584 W nominal @ 73 kV, 8 mA, 12 s
REFERENCE TIME PRODUCT
8 mAs @ 73 kV
FILTRATION
inherent filtration minimum 0.8 mm Al at 50 kV (IEC 60522/1999)
additional filtration minimum 2 mm Al
patient support attenuation equivalent less than 0.2 mm Al
total fltration minimum 2.8 mm Al at 70 kV
BEAM QUALITY
HVL over 2.77 mm Al at 73 kV
PRIMARY PROTECTIVE SHIELDING
minimum 0.5 mm Pb or equivalent
OUTER SHELL TEMPERATURE
+55ºC (131ºF) maximum
DUTY CYCLE
Duty cycle is controlled by the unit software.
Long term maximum duty cycle is 1:5
(Example: a 73 kV, 8 mA, 12 s exposure will have a 60 s cool-down period)

Power requirements
LINE CURRENT
100 - 120 VAC long term: 1.6 A (cont) 100 VAC mains
momentary: 10 A @ 73 kV/8 mA
220 - 240 VAC long term: 1 A (cont) 230 VAC mains
momentary: 4 A @ 73 kV/8 mA
MAXIMUM LINE IMPEDANCE
Maximum apparent resistance of supply mains
0.5 ohm
MAXIMUM LINE FUSING
100 - 120 VAC 16A
220 - 240 VAC 10 A
MAIN FUSE
T10A, SPT

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 GXDP-300 Appendix A. Technical Information

LINE SAFETY SWITCH (when required)

100 - 120 VAC Approved type, min. 16 A 250 VAC
220 - 240 VAC Approved type, min. 10 A 250 VAC
EARTH LEAKAGE CIRCUIT BREAKER (when required)
100 - 120 VAC Approved type, min. 16 A 250 VAC
220 - 240 VAC Approved type, min. 10 A 250 VAC,
breaker activation leakage current in accordance with local regulations.

Mechanical parameters
PANORAMIC
Source to Image layer Distance (SID) 500 mm (±10 mm)
Magnification factor 1.25
WEIGHT
120 kg
DIMENSIONS
(H x W x D) long leg 2340 x 835 x 776 mm
(H x W x D) short leg 2250 x 835 x 776 mm
VERTICAL HEIGHT OF CHIN REST
long leg 950 - 1750 mm (± 10 mm)
short leg 860 - 1660 mm (± 10 mm)

Digital image receptor (CCD)

PIXEL SIZE
96 microns
ACTIVE SENSOR SURFACE
147.5 x 6.1mm

Timer
EXPOSURE TIMES:
Normal 12.0 s
Child approx. 10.6 s
TMJ approx. 2.5 s + 2.5 s
Bitewing approx. 3 s + 3 s
Accuracy for the displayed exposure times ± 5%
SINGLE LOAD RATING
73 kV, 8 mA, 12 s, panoramic

BACK-UP TIMER
15 - 17 sec

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 Appendix A. Technical Information GXDP-300

Leakage technique factors

PANORAMIC
4800 mAs/h, exposure with maximum values
(73 kV, 8 mA, 12 s) according to the 1:5 duty cycle

Measurement bases
The kV is measured by monitoring differentially the current flowing through 450
Mohm, 1% feedback resistor connected between the tube anode and ground.
The mA is measured by monitoring current in the HT return line, which equals the
tube current.

Collimator
TYPE
BLD-M-1
PRIMARY SLIT
Adult panoramic slit only. For child panoramic the exposure time is reduced
to give a reduced length image.
PRIMARY SLIT SIZE
0.7 - 0.75 x 38 mm

Z-motor
DUTY-CYCLE
-Intermediate use: 6.25%, 25s ON, 400s OFF

Environmental data
OPERATING
- Ambient temperature from +10ºC to +40ºC
- Relative humidity 10 - 90%, no condensation
STORAGE/TRANSPORTATION
- Ambient temperature from -20ºC to +50ºC
- Relative humidity 5 - 85% no condensation
- Atmospheric pressure 500 - 1080 mbar

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 GXDP-300 Appendix A. Technical Information

System requirements and connections

- The PC and any other external device(s) connected to the system must meet
the IEC 60950 standard (minimum requirements). Devices that do not meet the
IEC 60950 standard must not be connected to the system as they may pose a
threat to operational safety.
- The PC and any other external devices must be connected in accordance with
IEC 60601-1-1.
- The x-ray unit must be connected to it’s own separate power supply. The PC
and any other external devices must NOT be connected to the same power
supply as the x-ray unit.
- Position the PC and any other external device at least 1.85 m (73”) from the
x-ray unit so that the patient cannot touch the PC or any other external device
while being x-rayed.
- The PC and any other external devices shall not be connected to an extension
cable.
- Multiple extension cables shall not be used.
- Do not position the PC where it could be splashed with liquids.
- Clean the PC in accordance with the manufacturer’s instructions.

X-ray system - to IEC 60601-1-1

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 Appendix A. Technical Information GXDP-300

Tube housing assembly cooling/heating characteristics

Tube rating chart Toshiba D-052 SB

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 GXDP-300 Appendix A. Technical Information

Anode thermal characteristics

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 Appendix A. Technical Information GXDP-300

A.2 Unit dimensions

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 GXDP-300 Appendix A. Technical Information

A.3 Symbols that appear on the unit

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 Appendix A. Technical Information GXDP-300

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 GXDP-300 Appendix A. Technical Information

A.4 EMC declaration

Guidance and manufacturer’s declaration – electromagnetic emissions

The GXDP-300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the GXDP-300 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The GXDP-300 uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class B The GXDP-300 is suitable for use in all
CISPR 11 establishments, including domestic establishments
and those directly connected to the public low-voltage
Harmonic Class A
power supply network that supplies buildings used for
emissions
domestic purposes.
IEC 61000-3-2
Voltage Complies
fluctuations/ flicker
emissions
IEC 61000-3-3

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 Appendix A. Technical Information GXDP-300

Guidance and manufacturer’s declaration – electromagnetic immunity

The GXDP-300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the GXDP-300 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic
environment - guidance
Electrostatic r6 kV contact r6 kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile.
IEC 61000-4-2 r8 kV air r8 kV air If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Electrical fast r2 kV for power supply r2 kV for power Mains power quality
transients/bursts lines supply lines should be that of a
IEC 61000-4-4 r1 kV for input/output r1 kV for typical commercial or
lines input/output lines hospital environment.
Surge r1 kV differential mode r1 kV differential Mains power quality
IEC 61000-4-5 r2 kV common mode mode should be that of a
r2 kV common typical commercial or
mode hospital environment.
Voltage dips, <5 % UT <5 % UT Mains power quality
short (>95 % dip in UT) (>95 % dip in UT) should be that of a
interruptions and for 0.5 cycle for 0.5 cycle typical commercial or
voltage variations hospital environment. If
on power supply 40 % UT 40 % UT user of the GXDP-300
lines (60 % dip in UT) (60 % dip in UT) requires continued
IEC 61000-4-11 for 5 cycles for 5 cycles operation during power
mains interruptions, it is
70 % UT 70 % UT recommended that the
(30 % dip in UT) (30 % dip in UT) GXDP-300 be powered
for 25 cycles for 25 cycles from an uninterruptible
power supply or a
<5 % UT <5 % UT battery.
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency
(50/60 Hz) magnetic field should be
magnetic field at levels characteristic
IEC 61000-4-8 of a typical location in a
typical commercial or
hospital environment.
NOTE UT is the ac. mains voltage prior to application of the test level.

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 GXDP-300 Appendix A. Technical Information

Guidance and manufacturer’s declaration – electromagnetic immunity

The GXDP-300 is intended for use in the electromagnetic environment specified below. The
customer or the user of the GXDP-300 should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment - guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to any
part of the GXDP-300, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3V d = 1.2 P
IEC 61000-4-6 150 kHz to
80 MHz d = 1.2 P 80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3 d = 2.3 P 800 MHz to 2.5 GHz
where P is the maximum output power rating
3 V/m 3 V/m of the transmitter in watts (W) according to
80 MHz to the transmitter manufacturer and d is the
2.5 GHz recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
a
survey , should be less than the compliance
b
level in each frequency range . Interference
may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the GXDP-300 is used exceeds the
applicable RF compliance level above, the GXDP-300 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting of relocating the GXDP-300.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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 Appendix A. Technical Information GXDP-300

Recommended separation distances between portable and mobile RF communications

equipment and the GXDP-300.
The GXDP-300 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the GXDP-300 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the GXDP-300 as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter m
output power of
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter W
d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

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