KaVo ProXam 3DQ User manual

KaVo ProXam 3DQ
Instructions for use
3D imaging
EN

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 1.015.1242 Revision 1
Released 1 March 2023

Table of contents
1 Introduction.................................................................................................................................................1
1.1 Intended use...................................................................................................................................1
1.2 Usage environment........................................................................................................................ 1
2 Associated documentation..........................................................................................................................2
3 Symbols on product labels..........................................................................................................................3
4 Safety precautions......................................................................................................................................5
4.1 Reporting serious incidents............................................................................................................ 8
5 Switching X-ray system on......................................................................................................................... 9
5.1 Switching X-ray unit on...................................................................................................................9
5.2 Switching 3D reconstruction PC 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.................................................................................................................................... 12
6.5 Patient supports............................................................................................................................13
6.5.1 Head supports (option A or B)......................................................................................13
6.5.2 Chin supports............................................................................................................... 14
6.6 Exposure switch........................................................................................................................... 14
6.7 Emergency stop button.................................................................................................................15
6.8 Touch screen................................................................................................................................15
6.9 ProTouch desktop application...................................................................................................... 19
6.10 Patient positioning controls...........................................................................................................21
6.10.1 X-ray unit up / down..................................................................................................... 21
6.10.2 Positioning joystick.......................................................................................................22
6.10.3 Image volume up / down.............................................................................................. 22
6.10.4 Open / close temple supports...................................................................................... 23
7 KaVo ProXam 3DQ programs.................................................................................................................. 24
7.1 3D Dental......................................................................................................................................24
7.2 3D Ear Nose Throat......................................................................................................................24
8 3D patient exposure..................................................................................................................................25
8.1 Preparing X-ray system................................................................................................................25
8.1.1 Attaching and removing sensor....................................................................................25
8.1.2 Attaching patient supports............................................................................................28
8.1.3 Preparing Romexis.......................................................................................................33
8.2 Preparing patient.......................................................................................................................... 33
8.3 Selecting exposure settings..........................................................................................................33
8.3.1 Selecting program........................................................................................................ 34
8.3.2 Selecting patient size................................................................................................... 34
8.3.3 Selecting volume diameter and height......................................................................... 35
8.3.4 Selecting volume position............................................................................................ 35
8.3.5 Selecting jaw side........................................................................................................ 36
8.4 Patient positioning........................................................................................................................ 37
8.4.1 Selecting patient entry position.................................................................................... 37
Instructions for use KaVo ProXam

8.4.2 Positioning patient's head............................................................................................ 37
8.5 Selecting exposure values............................................................................................................38
8.5.1 Selecting image resolution........................................................................................... 38
8.5.2 Selecting Ultra Low Dose (ULD).................................................................................. 39
8.5.3 Adjusting exposure values for current exposure.......................................................... 39
8.6 Selecting patient movement correction........................................................................................ 41
8.7 Adjusting volume position.............................................................................................................42
8.7.1 Moving image volume vertically (Z laser).....................................................................43
8.7.2 Moving image volume horizontally (X and Y lasers).................................................... 44
8.8 Taking scout image or 2D views (LAT, PA or LAT-PA)................................................................46
8.9 Taking 3D exposure..................................................................................................................... 49
9 Settings.....................................................................................................................................................52
9.1 User settings.................................................................................................................................52
9.1.1 Language (1100)..........................................................................................................52
9.1.2 Time and date (1200)...................................................................................................53
9.1.3 Operational settings (1300)..........................................................................................56
9.1.4 Network settings (1400)............................................................................................... 59
9.1.5 Testing routines (1500)................................................................................................ 60
9.2 Program settings.......................................................................................................................... 62
9.2.1 Programs (2100).......................................................................................................... 62
9.2.2 Program features (2200).............................................................................................. 63
9.2.3 Licences (2300)............................................................................................................64
9.2.4 Reset to Factory Defaults (2500)................................................................................. 65
9.3 About tab...................................................................................................................................... 66
9.3.1 Component information (4100).................................................................................... 66
9.3.2 Archive (4200)..............................................................................................................66
9.3.3 Product registration (4300)...........................................................................................66
10 Help messages.........................................................................................................................................68
11 Error messages........................................................................................................................................ 71
12 Cleaning and disinfection..........................................................................................................................72
12.1 Patient supports, patient handles and touch screen.....................................................................72
12.2 Other surfaces..............................................................................................................................75
13 Service......................................................................................................................................................77
14 Terms and conditions of warranty.............................................................................................................78
15 Disposal....................................................................................................................................................79
16 Technical specifications............................................................................................................................80
Table of contents
KaVo ProXam Instructions for use

1 Introduction
This Instructions for use describes how to take 3D exposures.
The Instructions for use applies to KaVo ProXam 3DQ.
NOTE
This Instructions for use is valid for software version 3.9.14 or later. This
software version is compatible with Romexis software version 6.4.2 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.
The X-ray images can be used to examine:
• Dentomaxillofacial area
• Ear, nose and throat
• Cervical spine
• Other cranial anatomies
You need a PC with the 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. Refer to section "Licences (2300)" on page 64 for a list of
available licences.
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.
KaVo ProXam is a trade name of Planmeca ProMax, manufactured for and
distributed by KaVo.
1.1 Intended use
The KaVo ProXam X-ray unit uses Narrow Beam Tomography (NBT) to
produce two-dimensional (2D) X-ray images and the KaVo ProXam 3D X-
ray units use Cone Beam Computed Tomography (CBCT) to produce three-
dimensional (3D) X-ray images. Panoramic, cephalometric and projection
radiography techniques are used for two-dimensional (2D) X-ray images.
The images can be used for examination of dentomaxillofacial, ear, nose
and throat, cervical spine, as well as other cranial anatomies. The X-ray unit
is allowed to be used only under supervision of a health care professional.
1.2 Usage environment
This X-ray unit is intended to be used in a professional healthcare
environment such as dental offices, clinics and similar environments.
1 Introduction
Instructions for use KaVo ProXam 1

2 Associated documentation
The X-ray unit is supplied with the following documents:
• Instructions for use
• Assembly instructions
• Technician's instructions
• Calibration instruction Device tool
These Instructions for use are intended to be used in conjunction with the
documentation for the Romexis program. The Romexis package contains the
following manuals:
• User’s Manual
• Technical Manual
The original language of the Instructions for use is English.
NOTE
The Instructions for use are available for download on the KaVo website.
2 Associated documentation
2 KaVo ProXam Instructions for use

3 Symbols on product labels
Fulfils the requirements of Directives 93/42/EEC and RoHS, REACH and
WEEE.
Medical Device
SGS listing marking according to US and Canadian standards (ANSI/AAMI
ES60601-1 and CAN/CSA C22.2 No. 60601- 1).
Date of manufacture (Standard ISO 7000).
Type B applied part (Standard IEC 60417).
Separate collection for electrical and electronic equipment according to
Directive 2012/19/EU (WEEE).
Consult electronic instructions for use (Standard ISO 7000-1641).
Refer to instruction manual/booklet (Standard ISO 7010).
Emergency stop (Standard IEC 60417)
Warning: Electricity (Standard ISO 7010).
To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Electrostatic sensitive device (Standard IEC 60417)
Warning, hot surface (Standard ISO 7010).
3 Symbols on product labels
Instructions for use KaVo ProXam 3

General warning (Standard ISO 7010).
3 Symbols on product labels
4 KaVo ProXam Instructions for use

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.
KaVo limited warranty does not cover damage which is due to misuse, for
example, 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 (for example, if the exposure button is released
or emergency stop button activated), guide the patient away from the X-ray
unit before moving the C-arm.
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
Instructions for use KaVo ProXam 5

CAUTION
Do not use the X-ray unit in an oxygen rich environment or in the presence
of flammable anaesthetics.
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.
CAUTION
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the X-ray unit, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
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.
4 Safety precautions
6 KaVo ProXam Instructions for use

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.
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
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, 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. 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
If you take an exposure but the image does not appear in the Romexis
program, you can import the image manually into Romexis. Refer to the
Romexis user's manual for details.
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.
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.
4 Safety precautions
Instructions for use KaVo ProXam 7

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
Portable mobile devices and other high frequency electromagnetic energy
emitting devices used close to the X-ray system may affect the system’s
performance. Diagnostic information of the X-ray image may be lost and
unnecessary X-ray dose to the patient may result.
4.1 Reporting serious incidents
Serious incidents that have occurred in relation to the device must be
reported to the manufacturer and the local competent authority.
4 Safety precautions
8 KaVo ProXam Instructions for use

5 Switching X-ray system on
NOTE
To prolong the lifetime of your X-ray system, always switch the X-ray system
off when it is not in active use.
5.1 Switching X-ray unit on
The on / off switch is located on the underside of the column top.
5.2 Switching 3D reconstruction PC on
The on / off switch is located at the top of the computer.
5 Switching X-ray system on
Instructions for use KaVo ProXam 9

6 Main parts
6.1 General view of X-ray system
1X-ray unit
23D reconstruction PC
3Romexis program
4ProTouch desktop application (optional, see section "ProTouch
desktop application" on page 19)
5Ethernet switch
6 Main parts
10 KaVo ProXam Instructions for use

6.2 General view of X-ray unit
1C-arm
2Sensor (see section "Sensor" on page 12)
3Tube head (see section "Tube head" on page 12)
4Patient supports (see section "Patient supports" on page 13)
5Patient support table
6Patient handles
7Patient positioning controls (see section "Patient positioning
controls" on page 21)
8Touch screen (see section "Touch screen" on page 15)
9Telescopic column
10 Stationary column
11 Emergency stop button (see section "Emergency stop button" on
page 15)
6 Main parts
Instructions for use KaVo ProXam 11

6.3 Sensor
13D sensor for KaVo ProXam 3DQ
6.4 Tube head
1Non-rotating tube head
2Rotating tube head
6 Main parts
12 KaVo ProXam Instructions for use

6.5 Patient supports
6.5.1 Head supports (option A or B)
Option A
1Adjustable head support
2Temple pads for children
3Fastening straps
4Support bars
Option B
1Head band 25
2Support bars
6 Main parts
Instructions for use KaVo ProXam 13

6.5.2 Chin supports
1Chin cup
2Adapter
6.6 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.
1Exposure switch
2Exposure button
6 Main parts
14 KaVo ProXam Instructions for use

6.7 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.
6.8 Touch screen
NOTE
The X-ray unit may be delivered with physical or virtual control panel (or
both). This Instructions for use is valid for all set-ups.
NOTE
The options shown on the touch screen depend on the unit configuration.
The X-ray unit can be upgraded with new programs and features, contact
your dealer for further information. The views and values shown in this
Instructions for use are only examples.
NOTE
The illustrations shown on the touch screen are based on approximate
patient anatomy. The actual exposure area depends on the individual
anatomy of the patient.
NOTE
Never allow patients to touch the screen when they are positioned in the X-
ray unit. Touching the screen during exposure will stop the imaging process.
6 Main parts
Instructions for use KaVo ProXam 15

Main screen
The main screen shows the name and the imaging programs of the X-ray
unit. You can use the buttons at the bottom of the main screen to change the
appearance of the main view.
Home button
To view up to five most recently used programs, select the home button. The
most recently used program is shown first. This is the default view of the
main screen.
NOTE
If you wish to use fast forward buttons on this view, select Settings >
Program > 2200 Program Features > 2240 General > Fast Forward ON.
Using a fast forward button takes you directly to the screen where you can
take an exposure.
Program group buttons
To view all the programs that are available for a program group, select the
program group button.
Making selections
To make a selection on the touch screen, touch a button or a field with your
finger or a soft stylus. The selected option is highlighted. To deselect an
option, touch the button or field again (or select another option if available).
You hear an audible signal when you make a selection. If you wish to adjust
the volume of the signal, select Settings > User > 1300 Operational Settings
> 1320 Audio Settings > Touch Volume.
NOTE
Do not use sharp objects to operate the touch screen.
Accept button
To accept a selection, select the green check mark button.
6 Main parts
16 KaVo ProXam Instructions for use