Planmeca Viso User manual

Planmeca Viso™
user's manual
EN
3000593130005931

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 30005931 Revision 20
Release Date 23 June 2022

Table of contents
1 Introduction.................................................................................................................................................1
1.1 Device description.......................................................................................................................... 1
1.2 Intended use...................................................................................................................................1
1.2.1 Usage environment........................................................................................................ 2
2 Associated documentation..........................................................................................................................3
3 Product registration.....................................................................................................................................4
4 Symbols......................................................................................................................................................5
4.1 Symbols on product labels............................................................................................................. 5
5 Safety precautions......................................................................................................................................7
6 Pediatric use.............................................................................................................................................13
6.1 Introduction...................................................................................................................................13
6.2 References for pediatric dose optimisation.................................................................................. 13
6.3 Device specific features and instructions..................................................................................... 13
7 Switching X-ray system on....................................................................................................................... 15
7.1 Switching X-ray unit on.................................................................................................................15
7.2 Switching 3D reconstruction PC on..............................................................................................15
8 Main parts.................................................................................................................................................16
8.1 General view of X-ray system.......................................................................................................16
8.2 General view of X-ray unit............................................................................................................ 17
8.3 Patient supports............................................................................................................................18
8.4 Exposure switch........................................................................................................................... 19
8.5 Emergency stop button.................................................................................................................19
8.6 Control panel................................................................................................................................ 20
9 Before exposure....................................................................................................................................... 27
9.1 Preparing X-ray system................................................................................................................27
9.1.1 Attaching patient supports............................................................................................27
9.1.2 Preparing Planmeca Romexis......................................................................................33
9.2 Preparing patient.......................................................................................................................... 33
10 2D exposure............................................................................................................................................. 34
10.1 2D dental programs......................................................................................................................34
10.2 Selecting imaging program...........................................................................................................35
10.3 Patient positioning........................................................................................................................ 36
10.4 Selecting patient size....................................................................................................................42
10.5 Adjusting exposure values for current exposure.......................................................................... 43
10.6 Taking 2D exposure..................................................................................................................... 44
10.6.1 2D Panoramic exposure...............................................................................................44
10.6.2 2D View exposure........................................................................................................ 46
11 3D exposure............................................................................................................................................. 50
11.1 3D dental programs......................................................................................................................50
11.1.1 Preset volume sizes..................................................................................................... 51
11.2 Selecting imaging program...........................................................................................................53
11.3 Patient positioning........................................................................................................................ 54
11.4 Selecting patient's left or right side...............................................................................................56
User's manual Planmeca Viso

11.5 Selecting patient size....................................................................................................................57
11.6 Adjusting image volume position and size....................................................................................58
11.7 Selecting image resolution, Ultra Low Dose (ULD) and ProFace.................................................60
11.8 Adjusting exposure values for current exposure.......................................................................... 60
11.9 Selecting Artefact Removal Algorithm (ARA) and patient movement correction (CALM)............ 62
11.10 Taking scout views....................................................................................................................... 63
11.11 Taking 3D exposure..................................................................................................................... 67
11.12 Taking 3D face photo................................................................................................................... 72
12 3D quality control......................................................................................................................................76
12.1 Safety notices and compatibility................................................................................................... 76
12.2 Running QA test........................................................................................................................... 77
12.3 Post-test process..........................................................................................................................81
13 Settings.....................................................................................................................................................82
13.1 User settings.................................................................................................................................82
13.1.1 Language (1100)..........................................................................................................82
13.1.2 Operational Settings (1300)......................................................................................... 83
13.1.3 Network Settings (1400)...............................................................................................85
13.1.4 Testing Routines (1500)...............................................................................................86
13.1.5 Exposure Values (1600)...............................................................................................88
13.1.6 Licences (1700)............................................................................................................89
13.2 About............................................................................................................................................ 90
13.2.1 Component Information (4100).................................................................................... 90
13.2.2 Archive (4200)..............................................................................................................91
13.2.3 Product Registration (4300)......................................................................................... 92
14 Help messages.........................................................................................................................................93
15 Error messages........................................................................................................................................ 96
16 Cleaning and disinfection..........................................................................................................................97
16.1 Patient supports, patient handles and touch screen.....................................................................97
16.2 Other surfaces............................................................................................................................100
17 Service....................................................................................................................................................101
18 Disposal..................................................................................................................................................102
19 Technical specifications..........................................................................................................................103
Table of contents
Planmeca Viso User's manual

1 Introduction
The manual applies to the following X-ray units:
• Planmeca Viso G5
• Planmeca Viso G7
NOTE
This manual is valid for Planmeca Viso software version 1.3.0 or later. This
software version is compatible with Planmeca Romexis software version
6.3.0 or later. To check the software version of your X-ray unit, select
Settings > About > 4100 Component Information > Viso ProTouch SW
Version.
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 (1700)" on page 89 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.
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.
1.1 Device description
The X-ray unit uses cone beam computed tomography (CBCT) to produce
three-dimensional (3D) images of the maxillofacial and ENT anatomies.
Two-dimensional (2D) images are produced with the tomosynthesis method
(panoramic imaging) as well as conventional 2D radiography (cephalometric
imaging, 2D views). If the X-ray unit has an active ProFace licence, you can
take a 3D photo of the patient's face.
In CBCT a cylindrical volume of data is captured in one imaging procedure.
The data consists of several hundred sample images which are taken from
different directions to cover a certain pre-programmed target area. These
samples are used for 3D reconstruction (using a separate 3D reconstruction
PC) that can be viewed in three dimensions using a separate workstation
and the Planmeca Romexis software.
1.2 Intended use
The X-ray unit system is a system intended to produce two-dimensional (2D)
and three-dimensional (3D) digital x-ray images as well as three-dimensional
(3D) and four-dimensional (4D) optical images of the dento-maxillo-facial,
cervical spine and ENT (Ear, Nose and Throat) regions at the direction
of healthcare professionals as diagnostic support for pediatric and adult
patients.
The 3D face photo can be used for patient education or in order to follow the
results of medical treatments.
1 Introduction
User's manual Planmeca Viso 1

1.2.1 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
2 Planmeca Viso User's manual

2 Associated documentation
The X-ray unit is supplied with the following manuals:
• User’s Manual
• Installation Manual
• Technical Manual
These manuals are intended to be used in conjunction with the
documentation for the Planmeca Romexis program. The Romexis package
contains the following manuals:
• User’s Manual
• Technical Manual
The original language of the manuals is English.
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.
2 Associated documentation
User's manual Planmeca Viso 3

3 Product registration
About this task
Follow these steps to register your X-ray unit on Planmeca's website.
Steps
1. Select Settings > About > 4300 Product Registration.
2. Do one of the following:
• If you have a QR (Quick Response) code reader installed on your
mobile device (e.g. smartphone), hold the device steady over the QR
code shown on the screen.
You are directed to Planmeca’s product registration page.
• Go to Planmeca’s product registration page at https://
www.planmeca.com/register.
3. Select the green check mark button.
4. Follow the instructions on the registration page.
NOTE
When you enter the X-ray unit serial number, you have to include any
letters shown at the beginning of the number.
3 Product registration
4 Planmeca Viso User's manual

4 Symbols
4.1 Symbols on product labels
Fulfils the requirements of Directive 93/42/EEC.
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).
Medical Device in accordance with (EU) 2017/745.
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)
4 Symbols
User's manual Planmeca Viso 5

Warning, hot surface (Standard ISO 7010).
General warning (Standard ISO 7010).
4 Symbols
6 Planmeca Viso User's manual

5 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
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.
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.
5 Safety precautions
User's manual Planmeca Viso 7

CAUTION
Do not modify the X-ray unit. The X-ray unit must be serviced by qualified
personnel only.
CAUTION
Be careful that the X-ray unit does not hit the ceiling when you move the
X-ray unit up. The maximum height can be adjusted to suit offices with a low
ceiling. Contact your service technician for help.
CAUTION
Make sure that there is no object under the X-ray unit when you move the
X-ray unit down. If something is in danger of becoming trapped, release
the height adjusting slider immediately to stop the movement. Clear any
obstruction before moving the X-ray unit again.
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.
5 Safety precautions
8 Planmeca Viso User's manual

NOTE
The column movement stops automatically if the emergency stop plate at the
bottom is pressed upward. Clear any obstruction before moving the X-ray
unit again.
NOTE
The adapter detaches itself from the patient support base if subjected to
excessive load. This is a safety feature that ensures that the patient's
head cannot get stuck if the patient faints or begins to fall when they are
positioned in the X-ray unit.
NOTE
When positioning seated patients (e.g. in a wheelchair) always first move the
X-ray unit down before you position the patient in the X-ray unit.
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.
5 Safety precautions
User's manual Planmeca Viso 9

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 control panel. 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.
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).
5 Safety precautions
10 Planmeca Viso User's manual

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
Contact your service technician if you have taken an exposure but the image
does not appear in the Planmeca Romexis program. You can import the last
ten images manually into Planmeca 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.
NOTE
Make sure that neither you nor your patient can get caught or hooked up on
any part of the X-ray unit. Keep loose items of clothing, hair and jewellery
tucked away safely.
NOTE
Do not touch the arm structures when the X-ray unit is moving.
5 Safety precautions
User's manual Planmeca Viso 11

NOTE
Do not touch the glass windows of the sensor. Fingerprints or other stains on
the glass surface destroy image quality.
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.
5 Safety precautions
12 Planmeca Viso User's manual

6 Pediatric use
6.1 Introduction
Special care should be exercised when imaging patients outside the typical
adult size range, especially smaller pediatric patients whose size does not
overlap the adult size range (typically children under the age of 13).
Exposure to ionising radiation is of particular concern in pediatric patients
because:
1. For certain organs and tumor types, younger patients are more
radiosensitive than adults (i.e. the cancer risk per unit dose of ionising
radiation is higher for younger patients).
2. Use of equipment and exposure settings designed for adults of average
size can result in excessive and unnecessary radiation exposure of
smaller patients.
3. Younger patients have a longer expected lifetime over which the effects
of radiation exposure may manifest as cancer.
To help reduce the risk of excessive radiation exposure, you should follow
the ALARA (As Low As Reasonably Achievable) principle and seek to
reduce radiation dose to only the amount necessary to obtain images that
are adequate clinically.
6.2 References for pediatric dose optimisation
The following resources provide information about pediatric imaging
radiation safety and / or radiation safety for cone beam computed
tomography devices:
• Pediatric X-ray Imaging (http://www.fda.gov/Radiation-EmittingProducts/
RadiationEmittingProductsandProcedures/ucm298899.htm)
• Medical X-ray Imaging (http://www.fda.gov/
Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/
MedicalImaging/MedicalX-Rays/default.htm)
6.3 Device specific features and instructions
The X-ray unit provides the following specific design features and
instructions that enable safer use with pediatric patients:
Design feature important to pediatric imaging
(standard or optional)
Refer to section
Head support that can be adjusted for pediatric
patients (standard)
"Patient positioning" on page 36 (2D panoramic
exposure) and "Patient positioning" on page 54
(3D exposure)
Preset control settings which clearly specify the
intended size range (standard)
"Selecting patient size" on page 42 (2D
panoramic exposure) and "Selecting patient
size" on page 57 (3D exposure)
Display and recording of patient dose or
dose index and ability to record other patient
information, e.g. age (standard)
"Control panel" on page 20 (Checking DAP
values)
Planmeca Romexis User's Manual (Entering
date of birth and Generating X-ray log book)
ULD (Ultra Low Dose) setting (optional) "Selecting image resolution, Ultra Low Dose
(ULD) and ProFace" on page 60
6 Pediatric use
User's manual Planmeca Viso 13

Design feature important to pediatric imaging
(standard or optional)
Refer to section
CALM (Correction Algorithm for Latent
Movement) setting (optional)
"Selecting Artefact Removal Algorithm (ARA)
and patient movement correction (CALM)" on
page 62
Scout views (standard) "Taking scout views" on page 63
User's manuals that consider the balance of
radiation exposure and image quality (standard)
"Introduction" on page 13, "Adjusting exposure
values for current exposure" on page 43 (2D
panoramic exposure) and "Adjusting exposure
values for current exposure" on page 60 (3D
exposure)
The X-ray unit provides the following specific testing information and
instructions.
Testing information Refer to section
Estimated patient dosimetry covering pediatric
size ranges (standard)
"Control panel" on page 20 (Checking DAP
values)
Planmeca Romexis User's Manual (Generating
X-ray log book)
Quality control instructions including tests to
ensure proper operation across a broad patient
size range (standard)
"3D quality control" on page 76
6 Pediatric use
14 Planmeca Viso User's manual

7 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.
7.1 Switching X-ray unit on
The on / off switch is located on the underside of the column top.
7.2 Switching 3D reconstruction PC on
The on / off switch is located at the top of the computer.
7 Switching X-ray system on
User's manual Planmeca Viso 15

8 Main parts
8.1 General view of X-ray system
1X-ray unit
23D reconstruction PC
3Planmeca Romexis program
4Ethernet switch
8 Main parts
16 Planmeca Viso User's manual