Planmeca Planmeca ProMax 3D s User manual

Planmeca ProMax®
3D s & 3D Classic
EN 10033255_15
user's manual
3D imaging

User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 1
Table of Contents
1 INTRODUCTION .................................................................................................................1
2 ASSOCIATED DOCUMENTATION ...................................................................................... 2
3 SYMBOLS ON PRODUCT LABELS ..................................................................................... 3
3.1 Symbols on permanently installed X-ray units ........................................................................ 3
3.2 Symbols on X-ray units with detachable power supply cord .................................................. 4
4 SAFETY PRECAUTIONS .................................................................................................... 5
5 SWITCHING X-RAY UNIT ON ............................................................................................. 9
6 MAIN PARTS .................................................................................................................... 10
6.1 General view of X-ray system ...............................................................................................10
6.2 General view of X-ray unit .................................................................................................... 11
6.3 Sensor .................................................................................................................................. 12
6.4 Tube head ............................................................................................................................ 13
6.5 Patient supports ................................................................................................................... 14
6.6 Telescopic column ................................................................................................................ 15
6.7 Exposure switch ................................................................................................................... 16
6.8 Emergency stop button ........................................................................................................ 16
6.9 Touch screen ........................................................................................................................ 17
6.10 ProTouch desktop application ..............................................................................................20
6.11 Patient positioning controls ................................................................................................... 21
7 PLANMECA PROMAX 3D s PROGRAMS .......................................................................... 23
7.1 3D Dental ............................................................................................................................. 23
7.2 3D Models ............................................................................................................................ 23
8 PLANMECA PROMAX 3D CLASSIC PROGRAMS .............................................................. 24
8.1 3D Dental ............................................................................................................................. 24
8.2 3D Models ............................................................................................................................ 24
9 3D PATIENT EXPOSURE ................................................................................................. 25
9.1 Preparing X-ray system ........................................................................................................ 25
9.2 Preparing patient .................................................................................................................. 32
9.3 Selecting exposure settings .................................................................................................. 33
9.4 Patient positioning ................................................................................................................ 37
9.5 Selecting exposure values .................................................................................................... 38
9.6 Selecting patient movement correction ................................................................................ 41
9.7 Selecting 3D face photo (X-ray units with ProFace sensor) ................................................. 41
9.8 Adjusting volume position ..................................................................................................... 42
9.9 Taking a scout image or 2D views (LAT, PA or LAT-PA) ..................................................... 46
9.10 Taking a 3D exposure .......................................................................................................... 49
10 3D FACE PHOTO ............................................................................................................. 51
10.1 Before exposure ................................................................................................................... 51
10.2 Patient positioning ................................................................................................................ 51
10.3 Selecting exposure settings .................................................................................................. 53
10.4 Taking a 3D face photo ........................................................................................................ 54
11 3D MODEL EXPOSURE .................................................................................................... 56
11.1 Calibrating X-ray unit for impression or plaster material ....................................................... 56
11.2 Taking an exposure of an impression or plaster cast ........................................................... 60

2 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
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
authorised 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 10033255 Revision 15
Release Date 26 April 2017
12 SETTINGS ....................................................................................................................... 65
12.1 User settings ......................................................................................................................... 66
12.2 Program settings ................................................................................................................... 75
12.3 About tab .............................................................................................................................. 78
13 HELP MESSAGES ............................................................................................................ 80
14 ERROR MESSAGES ......................................................................................................... 82
15 CLEANING AND DISINFECTION ...................................................................................... 83
15.1 Patient supports and patient handles ................................................................................... 83
15.2 Touch screen ........................................................................................................................ 85
15.3 Sensor .................................................................................................................................. 86
15.4 Other surfaces ...................................................................................................................... 87
16 SERVICE ......................................................................................................................... 88
17 DISPOSAL ....................................................................................................................... 89
18 TECHNICAL SPECIFICATIONS ........................................................................................ 90
18.1 Technical data for Planmeca ProMax product family ........................................................... 90
18.2 Original manufacturer ........................................................................................................... 95

1 INTRODUCTION
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 1
1 INTRODUCTION
This manual describes how to take 3D exposures. The
manual applies to the following X-ray units:
• Planmeca ProMax 3D
• Planmeca ProMax 3D s
• Planmeca ProMax 3D Classic
NOTE
This manual is valid for software version 3.9.0 or later. This
software version is compatible with Planmeca Romexis
software version 4.5.1.r or later. To check the software
version of your X-ray unit, select Settings > About > 4100
Component Information > ProMax SW version.
The X-ray unit uses Cone Beam Computed Tomography
(CBCT) to produce three-dimensional (3D) X-ray images.
Panoramic, cephalometric and projection radiography
techniques can be used for two-dimensional (2D) X-rays.
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 for examination of
dentomaxillofacial anatomy. 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.
Make sure that you are fully acquainted with the
appropriate radiation protection measures and these
instructions before you use the X-ray unit. Note that your
X-ray unit may not feature all the options described in
these instructions.
These instructions include options that may not be
available in all countries.
NOTE
The X-ray unit may be used by health care professionals
only.
NOTE
You can register your X-ray unit online as described in
section 12.3.3 “Product Registration (4300)” on page 79.

2 ASSOCIATED DOCUMENTATION
2 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
2 ASSOCIATED DOCUMENTATION
The X-ray unit is supplied with the following manuals:
• User’s Manual(s) for
- 3D Imaging, Original English publication: 10033255
(- 2D Imaging, Original English publication: 10033256,
optional)
(- Cephalostat, Original English publication: 10033034 or
10033035, optional)
• Installation Quick Guide,
Original English publication: 10039996
• Installation Manual,
Original English publication: 10038029
• Technical Manual,
Original English publication: 10033257
• Planmeca Device Tool Manual,
Original English publication: 10031558
These manuals are intended to be used in conjunction
with the documentation for the Planmeca Romexis
program. The Romexis package contains the following
manuals:
• User’s Manual,
Original English publication: 10014593
• Technical Manual,
Original English publication: 10037884
NOTE
The User’s Manuals are available on Planmeca’s website.
• For X-ray units, select Material bank > Manuals >
Imaging.
• For software products, select Material bank >
Manuals > Software.

3 SYMBOLS ON PRODUCT LABELS
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 3
3 SYMBOLS ON PRODUCT LABELS
3.1 Symbols on permanently installed X-ray units
CE marking according to European standard
(Directive 93/42/EEC)
SGS marking according to US and Canadian standards
(ANSI/UL 60601-1 and CAN/CSA C22.2 No. 601.1-M90)
Date of manufacture (Standard ISO 15223-1)
Type B applied part (Standard IEC 60601-1)
Separate collection for electrical and electronic equipment
(Directive 2002/96/EC WEEE)
Refer to instruction manual/booklet
(Standard ISO 7010-M002)
Emergency stop (Standard IEC 60601-1)
Warning; Electricity (Standard ISO 7010-W012)
Electrostatic sensitive device (Standard IEC 60417)
Warning; Hot surface (Standard ISO 7010-W017)
General warning sign (Standard ISO 7010-W001)
0598

3 SYMBOLS ON PRODUCT LABELS
4 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
3.2 Symbols on X-ray units with detachable power supply cord
CE marking according to European standard
(Directive 93/42/EEC)
SGS marking according to US and Canadian standards
(ANSI/UL 60601-1 and CAN/CSA C22.2 No. 601.1-M90)
Date of manufacture (Standard ISO 15223-1)
Type B applied part (Standard IEC 60601-1)
Separate collection for electrical and electronic equipment
(Directive 2002/96/EC WEEE)
Attention, consult accompanying documents
(Standard IEC 60601-1)
Alternating current (Standard IEC 60417)
Electrostatic sensitive device (Standard IEC 60417)
Warning; Hot surface (Standard ISO 7010-W017)
0598

4 SAFETY PRECAUTIONS
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 5
4 SAFETY PRECAUTIONS
WARNING
The following safety precautions must be observed in
order to avoid the risk of personal injury or damage to
the X-ray unit.
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
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 X-ray 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.
CAUTION
The patient positioning lights are laser lights. Do not
stare into the laser beam.
CAUTION
Do not drop the sensor. Planmeca limited warranty
does not cover damage which is due to misuse, e.g.
dropping the sensor, neglect, or any cause other than
ordinary use.
If you have any reason to believe that the sensor
might be faulty, take a test exposure before taking a
patient exposure.
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 touch an electrical connector and the patient
at the same time.
CAUTION
If the X-ray unit shows any signs of oil leakage,
switch the X-ray unit off and contact your service
technician for help.

4 SAFETY PRECAUTIONS
6 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
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.
CAUTION
Do not modify the X-ray unit. The X-ray unit must be
serviced by qualified personnel only.
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 equivalence
of at least 0.25 mm on both sides (front and back of the
patient).
NOTE
If the X-ray unit has been stored at temperatures under
+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.
NOTE
If exposures are taken in rapid succession, the X-ray tube
may overheat and a cooling time will flash on the touch
screen. The cooling time indicates the delay before the
next exposure can be taken.
NOTE
If the X-ray system is not connected to an Uninterruptible
Power Supply (UPS), switch the X-ray unit off and
disconnect the PCs from the mains during lightning
storms.

4 SAFETY PRECAUTIONS
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 7
NOTE
FOR US & CANADIAN USERS:
The laser lights are class II laser products (21 CFR §
1040.10).
NOTE
FOR EUROPEAN USERS:
The laser lights are class 1 laser products (Standard IEC /
EN 60825-1: 2007).
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 X-ray unit.
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 60601-1-1. 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
Contact your service technician if you have taken an
exposure but the image does not appear in the Planmeca
Romexis program. The last ten images can be manually
imported into Romexis.
NOTE
Do not handle liquids near or on the X-ray unit.
NOTE
Never place or hang any objects on any part of the X-ray
unit.
CAUTION
LASER RADIATION -
DO NOT STARE
INTO BEAM
1mW
635nm
CLASS II
LASER
PRODUCT
LBL-X-099
CLASS 1 LASER PRODUCT
APPAREIL À LASER DE CLASSE 1
IEC 60825-1:2007

4 SAFETY PRECAUTIONS
8 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
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
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. To
switch radiation off, select Settings > User > 1300
Operational settings > 1310 Use Mode > 1311 Set Demo
Mode.
Alternatively, use the 90° button at the bottom of the
screen to test the C-arm rotation before you take a 3D
exposure.
NOTE
Do not touch the arm structures when the X-ray unit is
moving.
NOTE
Patients are not allowed to hang on the patient handles.
NOTE
FOR X-RAY UNITS WITH ROTATING TUBE HEAD:
Do not touch the metal parts in the middle of the tube head.
They might be hot.
NOTE
FOR PROFACE SENSOR:
Do not touch the glass windows. Fingerprints or other
stains on the glass surface destroy image quality.
Tube_head_rotating.eps
Prof_6C.eps

5 SWITCHING X-RAY UNIT ON
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 9
5 SWITCHING X-RAY UNIT ON
The on / off switch is located on the underside of the
stationary column top.
NOTE
To prolong the lifetime of your X-ray unit, always switch the
X-ray unit off when it is not in active use.

6 MAIN PARTS
10 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
6 MAIN PARTS
6.1 General view of X-ray system
1X-ray unit
2 3D reconstruction PC
3 Planmeca Romexis program
4 ProTouch desktop application
(optional, see section 6.10 “ProTouch desktop application” on page 20)
5 Ethernet switch
1
3 & 4
2
5

6 MAIN PARTS
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 11
6.2 General view of X-ray unit
1 C-arm
2 Sensor (see section 6.3 “Sensor” on page 12)
3 Tube head (see section 6.4 “Tube head” on page 13)
4 Patient supports (see section 6.5 “Patient supports” on page 14)
5 Patient support table
6 Patient handles
7 Patient positioning controls
(see section 6.11 “Patient positioning controls” on page 21)
8 Touch screen (see section 6.9 “Touch screen” on page 17)
9 Telescopic column
(see section 6.6 “Telescopic column” on page 15)
10 Stationary column
11 Emergency stop button
(see section 6.8 “Emergency stop button” on page 16)
ProMax_main_ProGui.eps
1
2
4
5
6
7
8
9
10
11
3

6 MAIN PARTS
12 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
6.3 Sensor
1 3D sensor for Planmeca ProMax 3D s
2 3D sensor for Planmeca ProMax 3D Classic
3 ProFace sensor for Planmeca ProMax 3D s and Planmeca ProMax 3D Classic
Prof_1B.eps
12
3
3Ds_sensor.eps
3D_sensor.eps

6 MAIN PARTS
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 13
6.4 Tube head
1 Non-rotating tube head
2 Rotating tube head
12
Tube_head_rotating.eps
Tube_head_non_rotating.eps

6 MAIN PARTS
14 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
6.5 Patient supports
6.5.1 Head supports (A or B)
1 Adjustable head support 1. Head band 25
2 Temple pads for children 2. Support bars
3 Fastening straps
4 Support bars
Head_support_attach_2.eps
Support_bars.eps
B)
Support_bars.eps
A)
1
2
2
3
4
1
2

6 MAIN PARTS
User’s Manual (3D Imaging) Planmeca ProMax 3D s & 3D Classic 15
6.5.2 Chin supports
6.6 Telescopic column
1Chin cup
2 Chin support
3 Adjustable adapter
1 Telescopic column without accessory cabinet
2 Telescopic column with accessory cabinet
(three accessory boxes)
Chin1.eps
Lip1.eps
3Ds_3D_adapter_2.eps
12
3
Digi_accessory_cabinet.eps
12

6 MAIN PARTS
16 Planmeca ProMax 3D s & 3D Classic User’s Manual (3D Imaging)
6.7 Exposure switch
The exposure switch can be mounted on the wall, or it can
be hung from the hook provided on the stationary column
top if a protected area is within reach.
Green lights flash on the exposure button and on the
touch screen when the X-ray system is getting ready for
an exposure. The green lights stop flashing and stay on
continuously when the X-ray system is ready for an
exposure.
During exposure yellow radiation warning lights illuminate
on the exposure switch and on the touch screen. They
indicate that the X-ray unit is generating radiation.
6.8 Emergency stop button
The emergency stop button is located on the top of the
stationary column. 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. The
up / down movement will stop within a distance of 10 mm
(0.4 in.).
A help message will appear on the touch screen. Guide
the patient away from the X-ray unit. Then release the
emergency stop button. The X-ray unit will automatically
restart.
6_2.eps
1) Flashing green =
Getting ready
2) Continuous green =
Ready
3) Yellow = Radiation
Exposure switch
Exposure button