ProMax 3DMax 3DUserManual PDF
ProMax 3DMax 3DUserManual PDF
user's manual
TABLE OF CONTENTS
1 INTRODUCTION ..............................................................................................1
2 ASSOCIATED DOCUMENTATION .................................................................2
3 SYMBOLS ON PRODUCT LABELS ................................................................3
4 SAFETY PRECAUTIONS ................................................................................4
5 MAIN PARTS ...................................................................................................7
5.1 General view of system .................................................................................................. 7
5.2 General view of X-ray unit .............................................................................................. 8
5.3 Exposure switch ............................................................................................................. 9
5.4 Patient supports ........................................................................................................... 10
5.5 Emergency stop button ................................................................................................ 12
14 CLEANING .....................................................................................................71
15 SERVICE ........................................................................................................71
16 DISPOSAL .....................................................................................................72
17 HELP MESSAGES .........................................................................................73
18 ERROR MESSAGES .....................................................................................75
19 TECHNICAL SPECIFICATIONS ....................................................................76
19.1 Technical data for Planmeca ProMax product family ................................................... 76
19.2 Original manufacturer .................................................................................................. 80
19.3 Dimensions in mm (in.) ................................................................................................ 80
19.4 Minimum operational space requirements ................................................................... 80
The manufacturer, assembler, and importer are responsible for the safety, reliability
and performance of the X-ray 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
COPYRIGHT PLANMECA
Released: 7 July 2014
Publication part number: 10019220 revision 14
1 INTRODUCTION
This manual describes how to take 3D exposures. Make
sure that you are fully acquainted with the appropriate
radiation protection measures and these instructions
before you use the X-ray unit.
The X-ray unit uses Cone Beam Computed Tomography
(CBCT) to produce three-dimensional (3D) X-ray images.
If the X-ray unit has a ProFace sensor, you can take a 3D
photo of the patient’s face.
The X-ray images can be used to examine:
• Dentomaxillofacial area
• Ear, nose and throat
• Cervical spine
• Other cranial anatomies
The 3D face photo can be used for patient education or in
order to follow the results of medical treatments.
You need a PC with the Planmeca Romexis program in
order to save, view and modify the images.
NOTE The X-ray unit may be used by health care
professionals only.
2 ASSOCIATED DOCUMENTATION
The X-ray unit is supplied with the following manuals:
• User’s Manual,
Original English publication: 10019220
• Installation Manual,
Original English publication: 10019222
• Technical Manual,
Original English publication: 10019223
4 SAFETY PRECAUTIONS
CAUTION FOR US USERS:
Federal law restricts this device to sale by or
on the order of a health care professional.
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 The patient positioning lights are laser
lights. Do not stare into the laser beam.
CAUTION If an exposure is interrupted (e.g. exposure
button is released or emergency stop button
activated), the patient must be guided away
from the X-ray unit before the C-arm is
moved.
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 Do not touch an electrical connector and the
patient at the same time.
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 Do not use the X-ray unit in an oxygen rich
environment or in the presence of flammable
anesthetics.
CAUTION Never use a defective or damaged X-ray
system. Contact your service technician for
help.
NOTE It is very important that the place where the 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 Cone beam imaging should not be used for routine (or
screening) examinations. The imaging examinations
must be justified for each patient to demonstrate that
the benefits outweigh the risks.
NOTE When it is likely that evaluation of soft tissues will be
required as part of the patient’s radiological
assessment, conventional CT or MR medical imaging
should be used rather than CBCT.
NOTE Before taking an exposure, ask any female patient of
childbearing age whether she might be pregnant. The
X-ray unit is not intended for use on pregnant women.
NOTE FOR CANADIAN USERS:
All patients must be provided with a shielded apron for
gonad protection and a thyroid shield. The use of a
thyroid shield is especially important in children. The
shielded apron and thyroid shield should have a lead
LASER RADIATION -
DO NOT STARE
1mW
INTO BEAM
CLASS II
NOTE FOR US & CANADIAN USERS:
635nm LASER
PRODUCT
The patient positioning lights are class II laser
products (21 CFR § 1040.10).
NOTE If you have any reason to believe that the C-arm might
hit the patient during exposure (e.g. patients with wide
shoulders), take a test exposure without radiation
first. Refer to section 9.3 “Special functions (i400)” on
page 40 for information on how to switch radiation off.
NOTE Do not touch the arm structures when the X-ray unit is
moving.
NOTE Patients are not allowed to hang on the patient
ProFace sensor handles.
5 MAIN PARTS
5.1 General view of system
X-ray unit
3D reconstruction PC
3DMax_CBCT_ethernet.eps
Ethernet
Printer
C-arm
Patient support
table
Patient handles
Patient
positioning
Stationary column
controls
Control panel
3DMax_main_HB25.eps
Telescopic column
Chair
(included in delivery)
Exposure
indicator light
(AMBER)
Ready
indicator light
(GREEN)
the patient away from the X-ray unit. Then clear the help
message by touching OK.
A) B)
2
1
1
2 Hea
d_s
up
po
rt_a
ttac
h_2
.ep
s
Support_bars.eps
Support_bars.eps
Chin1.eps
2
Bite1.eps
1 Chin cup
2 Adapter
1
Chin1.eps
3
Bite1.eps
1 Chin cup
2 Spacer
3 Adapter
3DMax_main_HB25.eps
On / off switch
7 PROGRAMS
7.1 3D Dental
Example: Example:
Adult, Tooth, Ø50 mm, Adult, Tooth, Ø50 mm,
Mandible H55 mm, Incisor Maxilla H55 mm, Incisor
Example:
Example:
Adult, Teeth, Ø100 mm,
Adult, Teeth, Ø100 mm,
Mandible H55 mm, Teeth
H90 mm, Teeth
Jaw Ø130 mm
Example:
Example:
Adult, Jaw, Ø130 mm,
Mandible H55 mm, Teeth Adult, Jaw, Ø130 mm,
H90 mm, Teeth
Example:
Adult, Face, Ø130 mm, H130 mm
Face Ø130 mm
Example:
Adult, Face, Ø130 mm, H160 mm
Skull Ø230 mm
Example: Example:
Skull, Ø230 mm, Skull, Ø230 mm,
Lower skull H160 mm Upper skull H160 mm
Example:
Skull, Ø230 mm,
H260 mm
2/2
1/2
Example:
Horizontal Pair Ø50 mm Adult, Horizontal Pair, Ø50 mm,
Mandible H50 mm, Molars
2/2 1/2
2/2 1/2
Example:
Adult, Temporal Bone Pair, Ø100 mm, H90 mm
2/2 1/2
Vertebrae Ø100 mm
Example:
Adult, Vertebrae, Ø100 mm, H90 mm
Example:
Adult, Airways, Ø100 mm, H90 mm
Example:
Airways Ø130 mm Adult, Airways, Ø130 mm, H130 mm
7.3 3D Model
Ø80 mm
H40 mm
8 CONTROL PANEL
8.1 General about control panel
mGy mAs
You can set the X-ray unit so that the current time will be
shown at the bottom of the display. You can choose in
which format (e.g. 12:53) it will be shown. Refer to section
“Date & time (i210)” on page 33 for more information.
The estimated milliampere-second (mAs) value will be
shown at the top of the display for the exposure you are
going to take.
You can set the X-ray unit so that the estimated radiation
dose will be shown on the display in milligray (mGy).
Refer to section “Visual adjustments (i250)” on page 36
for more information.
You can set the X-ray unit so that also the actual radiation
dose will be shown in a pop-up window after each
Time exposure. The value shown on the display indicates the
highest radiation dose the patient was exposed to during
the exposure. Refer to section “Behavioural preferences
(i230)” on page 35 for more information. Note that you will
have to accept the pop-up message by touching OK.
Quick buttons
NOTE Selecting kV and mA values manually will override the
automatic quick button setting.
Quick buttons
NOTE To view the preset exposure values, refer to the tables
in chapter 11 “3D PATIENT EXPOSURE” on page 47.
3D ENT:
In program type Sinus the volume height can be set to:
- 90 mm (child & adult)
- 130 mm (child & adult)
- 160 mm (child & adult).
In program type Vertebrae the volume height can be set
to:
- 75 / 90 mm (child / adult)
- 110 / 130 mm (child / adult).
In program type Airways the volume height can be set to:
- 75 / 90 mm (child / adult)
- 110 / 130 mm (child / adult)
- 136 / 160 mm (child / adult).
9 INFORMATION DISPLAYS
CAUTION Some of the settings can be used to alter the
operation of the X-ray unit. Never use
functions that you are not familiar with.
NOTE The contents of the information displays depend on
the unit configuration. The displays shown here are
from an X-ray unit featuring all currently available
exposure programs.
• Disable radiation
This option allows you to switch the exposure
function on or off.
When the exposure function is switched off no
radiation is generated when you press the
exposure button. The C-arm will move normally but
no radiation will be generated and no radiation
warning signals will be given, i.e. this is a “dummy
run” function for training and demonstration
purposes. For example, you might want to
demonstrate the C-arm movements before taking
exposures of children or nervous patients.
Date and
time
Error code and
number of times
the error has occurred
Software version
More detailed description
This option allows you to warm up the X-ray tube, i.e. run
an X-ray tube seasoning process. This is necessary if the
X-ray unit has not been used for a few days and you
receive error message E332 (Arcing across X-ray tube).
Touch the Start field. The word Ready appears at the
bottom of the display and you can now press the
exposure button to start the seasoning process.
During the process the words Exposure and Wait will
appear on the display. You can press and hold down the
exposure button for the whole duration of the process or
remove your thumb from the exposure button when the
word Wait appears on the display.
sw._2eps
Positioning joystick
11 3D PATIENT EXPOSURE
11.1 Step 1: Before exposure
Support bars
Insert the support bars into the holes in the patient
support table and secure them in position by tightening
the locking knobs.
Locking
knobs
ProMax_5_2.eps
NOTE Ensure that you insert the support bars the right way
round.
ProMax_2_2.eps
Adjustable
head support If you are using the adjustable head support, slide it onto
the support bars.
He
ad
_su
pp
ort
_a
tta
ch
.ep
s
Support bars
Adjusting
knob
Temple pads
He
ad_s
uppo
rt_
for children
atta
ch_2
.eps
NOTE Use temple pads on both sides (not on one side only).
Head band
Support bars
Chin cup Insert the chin cup into the adapter. Insert the adapter into
the holes in the middle of the patient support table.
Chin1.eps
Adapter
Bite1.eps
Preparing patient
Ask the patient to remove any spectacles, hearing aids,
dentures, hairpins, and personal jewellery such as
earrings, necklaces and piercings as these can produce
shadows or reflections in the image. The patient should
also remove any loose items of clothing (e.g. scarf, tie)
that might get caught in the arm structures of the X-ray
unit.
NOTE High contrast objects, such as gold teeth or amalgam,
may cause artefacts in the image.
Step 5 NOTE If the X-ray unit has a ProFace sensor, you can take a
Step 3 3D photo of the patient’s face at the same time as you
take an X-ray image. Select Face Scan On to take both
images at the same time.
Child 96 8
Adolescent 96 9
Small adult 96 10
Average-sized adult 96 11
Large adult 96 12
Child 96 4
Adolescent 96 5
Small adult 96 6
Average-sized adult 96 7
Large adult 96 8
Incisor light
Guide the patient to the X-ray unit. The patient can sit or
stand during the exposure.
Positioning
controls
Move target area up The volume bottom light indicates the position where the
Image lower edge of the image volume will be.
volume
Check that the image volume is positioned at the correct
height for the exposure you wish to take. You can fine-
adjust the vertical position of the image volume by
pressing the target area up / down button. The lower edge
of the volume will move accordingly.
Side light (y coordinate) The volume center lights cross at the selected target
Front light
(x coordinate) position. The cross formed by the light beams indicates
the center of the image volume. With the patient
positioned in the unit, the volume center lights form red
lines on the front (front light) and on the left side (side
light) of the patient’s head.
Volume center
lights
Image
volume
y
The horizontal position of the image volume can be fine-
adjusted as follows.
Thumb wheel
patposlights3.eps
(side light =
y coordinate)
NOTE The incisor light indicates the front edge of the image
volume when a front target position is selected.
Image
volume
Incisor light =
Volume front edge
for front targets
Front light
(x coordinate)
Side light
(y coordinate) Large volumes (Ø110 mm or more):
• The side light (y coordinate) can also be adjusted by
moving the positioning joystick towards / away from
you.
Ø > 100 mm
Skull
Ø230 mm
patposlights3.eps
The green indicator lights and the word Ready will flash
while the X-ray unit moves to the ready position. They will
stop flashing when the X-ray unit has reached the ready
position. The Romexis program will now show the Waiting
for Exposure Start message on the computer screen.
Green ready
w_wall6_2.eps
indicator light
The green indicator lights will flash while the X-ray unit
moves to the ready position. They will stop flashing when
the X-ray unit has reached the ready position.
Green ready
indicator light
ps
Press and hold down the exposure button for the entire
Amber exposure duration of the exposure.
indicator light
During the exposure the radiation warning light on the
exposure switch and on the display will come on and you
will hear a radiation warning tone. A symbol indicating the
type of view (scout, lat-PA, lat or PA) you are taking will
appear on the jaw icon above the Ready field.
eps
Lat-PA
If you took a scout image you can now readjust the
volume position as described in section 11.4 “Step 7:
Adjusting volume position” on page 53 and then take a
new scout image as described above. Repeat the
procedure until the position is correct.
NOTE Scout images are not saved in the Romexis program.
12 3D FACE PHOTO
If the X-ray unit has a ProFace sensor, you can take a 3D
photo of the patient’s face.
ProFace sensor
Patient support
table
patposlights3.eps
Thumb wheel
(side light = y coordinate)
OR
Positioning joystick
(side light = y coordinate)
NOTE Make sure that you have selected the right patient and
3D exposure mode in the Planmeca Romexis program
before you take an exposure. Refer to the Romexis
User’s Manual.
The green indicator lights and the word Ready will flash
while the X-ray unit moves to the ready position. They will
stop flashing when the X-ray unit has reached the ready
Green ready position. The Romexis program will now show the Waiting
all6_2.eps
Press and hold down the exposure button for the entire
duration of the exposure. The C-arm moves around the
patient’s head and you hear a fast ticking sound when the
photo is taken.
When the C-arm has completed the exposure cycle you
XR_Dsw._2eps
13 3D MODEL EXPOSURE
CAUTION The 3D Model programs must not be used
for patient imaging. The programs are
intended for taking exposures of
impressions and plaster casts only.
Impression material
Calibration cup
(part number 10031325)
Let the material set. The setting time will depend on the
material used. Wait slightly longer than recommended in
the instructions supplied by the manufacturer to ensure
proper hardening.
Polystyrene disc
(Part number 10017436)
Adapter
1 70 12
2 76 12
3 82 12
4 88 12
5 96 12
Volume center
lights
Calibration cup
on polystyrene disc
On the X-ray unit, touch the Ready field to move the X-ray
unit to the ready position.
The green indicator lights will flash while the X-ray unit
moves to the ready position. They will stop flashing when
the X-ray unit has reached the ready position.
Green ready
all6_2.eps
indicator light
Amber exposure
indicator light
Press and hold down the exposure button for the entire
duration of the exposure.
During the exposure the radiation warning light on the
exposure switch and on the display will come on and you
will hear a radiation warning tone. Note that the exposure
will last longer than a 3D patient exposure.
PXR_Dsw._2eps
Adapter
50 mm
Volume center
lights
Impression
on polystyrene disc
Sensor
Move C-arm up
NOTE FOR PLASTER CASTS
Move the C-arm up about 13 mm (0.5 in.) by pressing
the image volume up button.
On the X-ray unit, touch the Ready field to move the X-ray
unit to the ready position.
The green indicator lights will flash while the X-ray unit
moves to the ready position. They will stop flashing when
the X-ray unit has reached the ready position.
Green ready
all6_2.eps
indicator light
Amber exposure
indicator light Press and hold down the exposure button for the entire
duration of the exposure.
During the exposure the radiation warning light on the
exposure switch and on the display will come on and you
will hear a radiation warning tone. Note that the exposure
will last longer than a 3D patient exposure.
R_Dsw._2eps
14 CLEANING
NOTE Disconnect the X-ray unit from mains before cleaning.
NOTE Do not use cleaning solutions in aerosol or spray form
directly on unit surfaces.
X-ray unit
Wipe with Wipe with
Autoclave soft cloth using soft cloth using
up to 135°C alcohol based mild cleaning
cleaning solution solution
3D head supports X X
(incl. support bars and
fastening straps)
Chin cup X X X
Patient handles X X
Other surfaces X
(incl. control panel)
Sensors
Wipe with soft cloth
(NO CLEANING Compressed air
SOLUTION)
3D sensor X
ProFace sensor; X
laser windows in the middle
ProFace sensor; X
other surfaces
(incl. glass windows on both
sides)
15 SERVICE
To guarantee user and patient safety and to ensure
consistent image quality, the X-ray unit must be checked
and recalibrated by a qualified Planmeca service
technician once a year or after every 10 000 exposures if
this is sooner. Refer to the Technical Manual for complete
servicing information.
16 DISPOSAL
In order to reduce the environmental load over the
product’s entire lifecycle, Planmeca’s products are
designed to be as safe as possible to manufacture, use
and dispose of.
Parts which can be recycled should always be taken to
the appropriate processing centers, after hazardous
waste has been removed. Disposal of obsolete units is
the responsibility of the waste possessor.
All parts and components containing hazardous materials,
as well as batteries, must be disposed of in accordance
with waste legislation and instructions issued by the
environmental authorities. Batteries must be disposed of
in compliance with the requirements of Directive 2006 / 66
/ EEC.
The risks involved and the necessary precautions must be
taken into account when handling waste products.
Recyclable Hazardous
Waste
Main materials material waste
Part disposal
for disposal (X) = (separate
site
if available collection)
- plastic PUR, X
other plastics X
Motors (X)
Component (X)
boards
Cables, Copper, X
transformers steel, X
transformer oil X
X-ray tube X
Packing Wood, X
cardboard, X
paper, X
polystyrene X
Other parts X
17 HELP MESSAGES
The X-ray unit incorporates a self-checking feature that
monitors the operation of the unit. If the system detects an
operating error a help message (e.g. H101) will appear on
the control panel.
The X-ray unit will not accept any commands from the
user until the help message is cleared from the display.
Clear the message by touching OK.
The following list shows, in numerical order, all the help
messages that can appear on the control panel.
18 ERROR MESSAGES
NOTE Contact your service technician for help if you receive
an error message.
19 TECHNICAL SPECIFICATIONS
NOTE: SEE TECHNICAL MANUAL FOR USER’S STATEMENT
Classification:
• Ceph 1 - 16 mA ±10%
Anode current
(X-ray units with SW 3.0 or later):
• 3D 3D s / 3D Classic / 3D Plus / 3D Mid:
1 - 14 mA ±10%
3D Max: 1 - 12.5 mA ±10%
• Pan / SmartPan 1 - 16 mA ±10%
• Scanning ceph 1 - 16 mA ±10%
• Planmeca ProCeph 16 mA ±10%
mAs range min. / max. as indicated ±(10% + 0.2 mAs)
Exposure time:
• 3D 3D s:
Pulsed, effective 4.8 - 36 s as indicated ±10%
3D Classic / 3D Plus / 3D Mid:
Pulsed, effective 2.4 - 36 s as indicated ±10%
3D Max:
Pulsed, effective 3.6 - 24 s as indicated ±10%
• Pan 2D / 3D Classic:
2.7 - 16 s as indicated ±10%
2D tomography: 4 - 12 s as indicated ±10%
• SmartPan 3D s / 3D Classic:
3.3 - 19 s as indicated ±10%
3D Plus / 3D Mid: 3.7 - 23 s as indicated ±10%
3D Max: 10 s as indicated ±10%
• Scanning ceph / Normal 12 - 18.7 s as indicated ±10%
• Scanning ceph / High Speed 6.4 - 9.9 s as indicated ±10%
• Planmeca ProCeph 0.1 - 0.8 s as indicated ±10%
SID:
• 3D 3D s / 3D Classic: 1.57
3D Plus / 3D Mid: 1.38, 1.44 or 1.80
3D Max: 1.38, 1.41 or 1.80
Fuses:
Weight:
Environmental requirements
Transport:
Image properties
3D:
• Pixel size 48 m
• Pan active surface 6 x 146 mm (0.24 x 5.74 in.)
• Ceph active surface 6 x 292 mm (0.24 x 11.15 in.)
Planmeca ProCeph:
1351 (53.2”)
Ø1
(3 010
9.
8”
)
3DMax_dimensions.eps