KaVo ProXam iOS User manual

KaVo ProXam iOS
Instructions for use
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 1.015.1250 Revision 1
Released 01 March 2023

Table of contents
1 Introduction.................................................................................................................................................1
1.1 Intended use...................................................................................................................................1
1.1.1 Contraindications........................................................................................................... 1
1.1.2 Clinical benefits.............................................................................................................. 1
1.1.3 Patient target group........................................................................................................2
1.1.4 Inteded users................................................................................................................. 2
1.1.5 Inteded use environment................................................................................................2
1.1.6 Side effects.................................................................................................................... 2
1.2 Software and hardware upgrades.................................................................................................. 2
2 Associated documentation..........................................................................................................................3
3 Symbols on product labels..........................................................................................................................4
4 Safety precautions......................................................................................................................................7
4.1 Reporting serious incidents............................................................................................................ 9
4.2 Cyber security...............................................................................................................................10
4.2.1 System default settings - no user action required........................................................ 10
5 Getting started.......................................................................................................................................... 11
5.1 Starting Romexis.......................................................................................................................... 11
5.2 Managing cases in Romexis.........................................................................................................11
5.2.1 Searching and managing patients and images............................................................ 11
5.2.2 DICOM storage (optional)............................................................................................ 12
5.2.3 Viewing and opening cases in Romexis 3D module.................................................... 12
5.2.4 Combining model to 3D volume................................................................................... 12
6 Scanner setup...........................................................................................................................................13
6.1 Connecting scanner cable............................................................................................................13
6.2 Plugging scanner into laptop........................................................................................................ 14
6.3 Scanner tips..................................................................................................................................15
6.3.1 Attaching/removing scanner tip....................................................................................17
6.4 Scanner holder............................................................................................................................. 18
7 Relocating laptop and/or scanner.............................................................................................................19
8 Romexis CAD/CAM module overview...................................................................................................... 20
8.1 Creating and opening case...........................................................................................................20
8.1.1 Starting new CAD/CAM case....................................................................................... 20
8.1.2 Open existing CAD/CAM case..................................................................................... 20
8.2 Moving/viewing 3D models...........................................................................................................21
8.2.1 Rotating model............................................................................................................. 21
8.2.2 Changing model size....................................................................................................21
8.2.3 Moving model...............................................................................................................22
8.3 Settings.........................................................................................................................................23
8.3.1 Settings screen............................................................................................................ 23
8.3.2 General........................................................................................................................ 23
8.3.3 Scan settings................................................................................................................24
8.3.4 Margin settings.............................................................................................................24
8.3.5 Colours.........................................................................................................................24
8.3.6 About settings.............................................................................................................. 25
Instructions for use KaVo ProXam iOS

9 Scanning...................................................................................................................................................26
9.1 Scanner status..............................................................................................................................26
9.2 Tip information..............................................................................................................................27
9.3 Scanner icons...............................................................................................................................27
9.3.1 Sun icon....................................................................................................................... 27
9.3.2 Imaging mode.............................................................................................................. 27
9.3.3 Colour balancing.......................................................................................................... 28
9.4 Button and motion controls...........................................................................................................28
9.4.1 Top button.................................................................................................................... 28
9.4.2 Bottom button...............................................................................................................29
9.4.3 Top and bottom buttons pressed simultaneously.........................................................29
9.5 Positioning scanner...................................................................................................................... 30
9.6 Basic scanning steps....................................................................................................................30
9.7 Workflows.....................................................................................................................................31
9.7.1 Editing layers................................................................................................................31
9.8 Scanning groups...........................................................................................................................32
9.9 Model scanning............................................................................................................................ 32
9.10 Scanning live view........................................................................................................................33
9.10.1 Adjust live view size..................................................................................................... 33
9.10.2 Checking scanning distance........................................................................................ 34
9.10.3 Session usage..............................................................................................................35
9.11 Saving live view image................................................................................................................. 36
9.12 Evaluating model..........................................................................................................................36
9.13 View controls................................................................................................................................ 37
9.14 Generating model.........................................................................................................................38
9.15 Eraser tool.................................................................................................................................... 38
9.16 Triming model...............................................................................................................................40
9.17 Colour model or stone model....................................................................................................... 41
9.18 Checking model for missing data................................................................................................. 41
9.19 Delete model................................................................................................................................ 42
9.20 Scanning upper and lowel............................................................................................................ 43
9.21 Editing scan layer......................................................................................................................... 43
9.22 Shade assist.................................................................................................................................43
9.23 Scanning buccal bite.................................................................................................................... 44
9.23.1 Scanning bilateral buccal bite...................................................................................... 47
9.24 Occlusal contact strength............................................................................................................. 47
9.25 Model alignment groups............................................................................................................... 48
9.25.1 Create new alignment group........................................................................................ 48
9.25.2 Buccalless bite alignment.............................................................................................48
9.25.3 Add to group.................................................................................................................49
9.25.4 Manual alignment.........................................................................................................49
9.26 Object browser............................................................................................................................. 50
9.27 Scanning pre-op........................................................................................................................... 50
9.28 Scan body workflow......................................................................................................................51
9.29 Scanning impressions.................................................................................................................. 52
9.30 Full arch scanning........................................................................................................................ 54
9.31 Open bite scan............................................................................................................................. 55
9.32 360º Scanning.............................................................................................................................. 56
9.33 Import model.................................................................................................................................56
9.34 Export model................................................................................................................................ 57
10 Margin tab.................................................................................................................................................58
10.1 Draw margin................................................................................................................................. 58
10.2 Views............................................................................................................................................60
10.2.1 Color model view..........................................................................................................60
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KaVo ProXam iOS Instructions for use

10.2.2 Slice plane....................................................................................................................60
10.2.3 Show/hide margin........................................................................................................ 62
10.2.4 Model opacity............................................................................................................... 62
10.3 Path of insertion............................................................................................................................62
10.4 Editing margin...............................................................................................................................63
11 Analyse tab...............................................................................................................................................65
11.1 Preparation tools.......................................................................................................................... 65
11.2 Defining occlusion plane...............................................................................................................65
11.2.1 3-point alignment..........................................................................................................66
11.2.2 Manual alignment.........................................................................................................68
11.3 Trimming model............................................................................................................................69
11.4 View tools..................................................................................................................................... 71
11.4.1 Calculate contact map..................................................................................................71
11.4.2 Calculate undercuts..................................................................................................... 72
11.4.3 Colours.........................................................................................................................73
11.4.4 Taking 2D quickshot.....................................................................................................74
11.5 Measurement tools.......................................................................................................................74
11.5.1 Point-to-point measurement.........................................................................................74
11.5.2 Tooth width measurement............................................................................................75
11.5.3 Arch length measurement............................................................................................ 76
11.5.4 Curve measurement.....................................................................................................79
11.5.5 LM-Activator arch length measurement....................................................................... 79
11.5.6 Drawing tooth margin................................................................................................... 82
11.5.7 Fine-tuning measurements.......................................................................................... 84
11.5.8 Editing models in object browser................................................................................. 85
11.6 Analyses.......................................................................................................................................86
11.7 Comparison tools..........................................................................................................................86
11.7.1 Side-by-side comparison..............................................................................................86
11.7.2 Superimposition........................................................................................................... 87
11.7.3 Sync camera................................................................................................................ 88
11.7.4 Fit surface models........................................................................................................88
11.8 3D printing.................................................................................................................................... 89
11.8.1 Creating 3D printable models.......................................................................................89
11.8.2 Exporting 3D models with bases..................................................................................90
12 Send tab................................................................................................................................................... 91
12.1 Opening and inactivating cases in Case list.................................................................................91
12.2 File................................................................................................................................................91
12.2.1 Importing 3D models.................................................................................................... 91
12.2.2 Filling in lab order form.................................................................................................92
12.2.3 Adding abutments to lab order form.............................................................................95
12.2.4 Adding bridges to lab order form..................................................................................96
12.2.5 Sending lab order form.................................................................................................96
12.3 Export........................................................................................................................................... 97
12.4 Send............................................................................................................................................. 97
12.4.1 Romexis Cloud.............................................................................................................97
12.4.2 DDX Cloud................................................................................................................... 98
12.4.3 TruAbutment................................................................................................................ 98
12.4.4 HeySmile......................................................................................................................98
12.4.5 Sim to Care.................................................................................................................. 99
13 Cleaning / preventive maintenance........................................................................................................ 101
13.1 Tip infection control procedure................................................................................................... 101
13.1.1 Cleaning tip after every patient.................................................................................. 102
13.1.2 Storage.......................................................................................................................103
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Instructions for use KaVo ProXam iOS

13.2 Cleaning scanner base and other surfaces after every patient.................................................. 104
13.2.1 Cleaning/changing the scanner cover........................................................................105
14 Service....................................................................................................................................................107
15 Technical specifications..........................................................................................................................108
15.1 KaVo ProXam iOS specification.................................................................................................108
15.1.1 Applicable standards..................................................................................................109
15.1.2 Approvals (all systems).............................................................................................. 110
15.1.3 Optical specifications................................................................................................. 110
15.1.4 External components and connectors........................................................................111
15.1.5 UL listing.................................................................................................................... 111
16 EMC information.....................................................................................................................................112
17 FAQ........................................................................................................................................................ 116
18 System warnings.................................................................................................................................... 120
19 Saving screen shots............................................................................................................................... 121
20 Disposal..................................................................................................................................................122
Table of contents
KaVo ProXam iOS Instructions for use

1 Introduction
The KaVo ProXam iOS optical impression scanner is intended for dental
offices or laboratories. The scanner can be used as a complete optical
impression system for CAD/CAM of dental restorations in different digital
workflows in Romexis or exported to a third party.
NOTE
KaVo ProXam iOS is not indicated for any indication beyond dentistry.
This manual is valid for Romexis software revision 6.4 or later.
NOTE
The Romexis CAD/CAM module is available under license.
NOTE
Some of the screenshots may have been taken in earlier software versions
and may not exactly match your screen.
NOTE
FOR US USERS: Federal law restricts the scanner to sale by or on the order
of a health care professional.
NOTE
Throughout the manual, important notes and items of interest are formatted
like this example.
1.1 Intended use
The optical impression system is used to record the topographical
characteristics of the dentition and/or full arch and preparation areas
(including features such as implant scan locator fixtures, braces, brackets,
etc.). In addition it can record the topographical characteristics of the oral
anatomy (such as soft tissue, gingivae and palate).
The three dimensional model generated from the scan may be further
used for study models, and for the design and manufacturing of dental
restorations including implant supported prostheses and full and partial
frameworks, and can be used to design and manufacture physical models
of the teeth.
It may be used in conjunction with production of orthodontic appliances,
retainer and accessories.
1.1.1 Contraindications
The scanner is not intended for use with indications other than those
specifically mentioned.
The scanner is not intended to provide direct diagnosis or to replace
the decision of the dentist, with regard to clinical acceptability of the
manufactured restoration.
1.1.2 Clinical benefits
The use of the optical impression system:
• reduces the need for traditional impression materials
• facilitates treatment planning
1 Introduction
Instructions for use KaVo ProXam iOS 1

• facilitates perfection of design
• facilitates accuracy of the final restoration.
1.1.3 Patient target group
The optical impression system is suitable for any patient whose general
health is acceptable for dental treatment.
1.1.4 Inteded users
The optical impression system is inteded for dentists, dental assistants,
dental lab technicians, and other dental professionals that have received
training on the system.
1.1.5 Inteded use environment
The optical impression system is intended to be used in indoor environments
only, such as dental offices, dental laboratories, and dental schools.
1.1.6 Side effects
No side effects have been identified for the scanner.
1.2 Software and hardware upgrades
System software and hardware upgrades are initiated through the
manufacturer only. No software or hardware should be added to or deleted
from the manufacturer systems without prior approval of the manufacturer.
Doing so may result in damage to the system and will void the product
warranty.
1 Introduction
2 KaVo ProXam iOS Instructions for use

2 Associated documentation
• Romexis 6 user's manual
2 Associated documentation
Instructions for use KaVo ProXam iOS 3

3 Symbols on product labels
The following symbols are used on various labels on the system.
Affixed to the system are product identification labels that contain
identification and safety information. The following images show each safety
and warning label and describe where on the apparatus each can be found.
Be certain to read all product labelling.
NOTE
If any of the labels are missing or illegible, please contact the manufacturer
for replacement labels.
NOTE
The labels may have changed since this manual was published.
NOTE
Label examples are not shown in their actual size.
Alternating current (Standard IEC 60417)
Refer to instruction manual/booklet (Standard ISO 7010).
Autoclavable at temperature specified.
Fulfils the requirements of (EU) 2017/745.
Class 2 electrical product
Catalogue number (Standard ISO 7000)
Dangerous Voltage ISO 3864-B.3.6
Date of manufacture (Standard ISO 7000).
Direct current
3 Symbols on product labels
4 KaVo ProXam iOS Instructions for use

Disposable item. Do not reuse. (Standard ISO 7000).
Fragile
General mandatory action
General warning (Standard ISO 7010).
Humidity limitation
Keep away from rain.
Laser information
Laser warning
Lot number
Manufacturer (Standard ISO 7000).
Laser class 1 (Standard IEC 60825)
Class 1 laser product (Standard EN 60825-1: 2007)
3 Symbols on product labels
Instructions for use KaVo ProXam iOS 5

Medical Device
OFF Power IEC 60417-5008.
ON Power IEC 60417-5007.
On/Off Power IEC 60417-5010.
Consult electronic instructions for use (Standard ISO 7000-1641).
Operating temperature limits
Separate collection for electrical and electronic equipment according to
Directive 2012/19/EU (WEEE).
Serial number (Standard ISO 7000).
Standby IEC 60417-5010
Storage temperature limits
Type B applied part (Standard IEC 60417).
UL Laboratory Equipment Listing
3 Symbols on product labels
6 KaVo ProXam iOS Instructions for use

4 Safety precautions
The user must read and comply with all safety, warning, and instructional
labels on the scanner.
Ensure your scanner is properly maintained through periodic maintenance. If
you suspect equipment malfunction or failure, discontinue using the scanner
and contact technical support immediately. Do not attempt to make any
repairs on the scanner.
Warning denotes something that can cause personal injury to the patient or
the user.
Caution denotes something that can cause damage to the equipment.
WARNING
Failure to adhere to all safety warnings may result in personal injury,
equipment damage, or data loss.
WARNING
Do not use the scanner for any purpose other than its intended and labelled
use.
WARNING
This is a Class A product. In a domestic environment the scanner may cause
radio interference in which case the user may be required to take adequate
measures.
WARNING
When connecting the components, use only the cables supplied with the
scanner. Failure to do so may result in increased electromagnetic emissions
or reduced immunity to external electromagnetic emissions.
WARNING
Do not make any unauthorised repairs or modifications to the system
software or hardware. This includes installing unauthorised software on
the host computer system or altering or bypassing any safety switches
or mechanisms. Changes or modifications not expressly approved by the
manufacturer could void the user’s authority to operate the equipment.
WARNING
Do not install or operate the scanner in an environment where an explosion
hazard exists, for example in a high oxygen area.
WARNING
Do not attach any equipment or devices to the scanner unless their use has
been specifically authorised by the manufacturer.
4 Safety precautions
Instructions for use KaVo ProXam iOS 7

WARNING
The wireless components in the scanner may be interfered with by other
equipment, even if the other equipment is fully compliant with International
Special Committee on Radio Interference (CISPR) emission requirements.
WARNING
When possible, electrical equipment should not be used when adjacent
to other electrical equipment. If adjacent use is necessary, the equipment
should be observed to verify normal operation in the configuration in which it
will be used.
CAUTION
Comply with all applicable regulations when disposing of waste materials
from the scanner. To avoid cross-contamination, dispose of all potential
biohazard waste materials in accordance with local procedures and
guidelines.
WARNING
The scanner is a high precision Class 2 laser scanning instrument. Always
store the scanner in its holder when not in use. To prevent damage or
misalignment, do not drop or strike the scanner. Follow all stated precautions
when using the scanner.
WARNING
To prevent electrical shock and eye damage by laser radiation, do not open
any sealed covers or connectors with user restricted access.
WARNING
In case of emergency unplug the scanner from the computer port and/or
unplug the computer power cord from the wall or from the computer.
WARNING
The scanner is designed to be used with the tip connected to the scanner.
The connector pins on the scanner are energised when the tip is removed.
To ensure safety of the user and patient, do not touch the pins when the tip
is removed.
CAUTION
Medical electrical equipment requires special precautions regarding
Electromagnetic Compatibility (EMC). The scanner must be installed and
placed into service according to the EMC information provided in the
documentation that accompanies the scanner.
CAUTION
Portable and mobile Radio Frequency (RF) communications equipment can
affect medical electrical equipment.
4 Safety precautions
8 KaVo ProXam iOS Instructions for use

WARNING
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 scanner, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result. The wireless components in the scanner may be interfered
with by other equipment, even if the other equipment is fully compliant with
CISPR emission requirements.
CAUTION
After using the scanner on a patient, clean the scanner according to the
cleaning instructions found in section "Cleaning / preventive maintenance"
on page 101.
CAUTION
Do not hold the scanner in a way that will cover the cooling vents.
CAUTION
Do not immerse the scanner base in liquid or expose the scanner to
conditions outside the operating conditions, see section "KaVo ProXam iOS
specification" on page 108. Clean the scanner according to the instructions
in section "Cleaning / preventive maintenance" on page 101.
CAUTION
Do not stack the tips near or on any other metal instruments.
CAUTION
Ensure your scanner is properly maintained, see section "Cleaning /
preventive maintenance" on page 101.
CAUTION
If you suspect equipment malfunction or failure, discontinue using the
scanner and contact technical support immediately. Do not attempt to make
any repairs on the scanner.
CAUTION
Read and comply with all safety, warning, and instructional labels on the
scanner.
CAUTION
If the scanner has been operational for an extended period of time, the
surface may become warm to the touch. If the temperature becomes too
warm to the touch within a minute of use, turn it off and allow it to cool. The
surface of the applied part (scanning tip) may reach a temperature of 43°C
during normal operation. This is necessary to prevent fogging of the mirror
and is safe for patient contact.
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
Instructions for use KaVo ProXam iOS 9

4.2 Cyber security
Cyber security is the practice of defending computers, servers, mobile
devices, electronic systems, networks, and data from malicious attacks.
The following are things you can do to minimise security threats.
User name/password
For ease of use, your system has an automatic Windows login. To provide
more safety, it is recommended that you disable the automatic Windows
login and add a password to the screen saver. Passwords should be strong
and changed every few months.
You do not need to set up a different account for each user unless that is
your preference.
Physical security
For ease of use, your system has an automatic Windows login. If you do
not use a user name and password, it is important to secure the laptop
physically to ensure system safety.
• Laptop should be kept in a secure environment away from public access.
• Unauthorised people should not have access to the system.
Wireless networks
The system should only be connected to password protected networks.
Open (unlocked) networks can make your system vulnerable.
4.2.1 System default settings - no user action required
The following items are setup to protect your system by default and should
not be disabled or changed unless requested by customer support. This list
is being provided for your information and does not require any action by the
user.
• Windows firewall must be enabled and running with security levels
blocking all requests for incoming connections. Exceptions can be
allowed for predetermined, trusted applications.
NOTE
Customer support will connect with your system when needed, but the
initiation of this link will start on the user’s end and with their permission.
They will walk you through the process if/when it is needed.
• Windows firewall must be enabled, running, and kept up to date to allow
detection and handling of malware threats.
• Automatic security update installation is enabled.
• If you want to encrypt your data, you can use TPM 2.0 (Trusted platform
Module) with Window Bit Locker encryption. This is built into Windows
and is recommended for laptops which are portable and vulnerable to
theft.
4 Safety precautions
10 KaVo ProXam iOS Instructions for use

5 Getting started
To start using the Romexis and the CAD/CAM module you need to:
• Start Romexis (see section "Starting Romexis" on page 11).
• Activate your Romexis license.
• Log in to Romexis
NOTE
For detailed instructions see the Romexis user’s manual.
5.1 Starting Romexis
Steps
1. Press the power button to start the laptop.
2. On your keyboard, press the Windows key to make the standard desktop
appear if desired.
3. Once the desktop is visible, double-click the Romexis icon on your
desktop or on the Windows menu.
The following message may appear from Windows: Do you want to allow
the following program to make changes to this computer?
4. Click Yes.
This is a normal safety feature in Windows.
Results
The software opens to the Home screen.
What to do next
NOTE
To save electricity remember to turn off the system while not using the
scanner.
5.2 Managing cases in Romexis
5.2.1 Searching and managing patients and images
For detailed descriptions see the following sections in the Romexis user’s
manual:
• "Patients module"
• "Searching patients"
• "DICOM Query/Retrieve (optional)"
5 Getting started
Instructions for use KaVo ProXam iOS 11

5.2.2 DICOM storage (optional)
With Digital Imaging and Communication in Medicine (DICOM) Full license
images can be sent to a remote DICOM application, i.e. DICOM image
archive PACS. DICOM Storage needs to be configured in the
Admin module
before the DICOM storage can be used, see section "Imaging - DICOM" in
the Romexis technical manual (1.015.1955).
5.2.3 Viewing and opening cases in Romexis 3D module
All scans and designed restorations will automatically appear in the 3D
module volumes list.
To view and open scans and cases in Romexis see section "Viewing
CAD/CAM case in 3D module" in Romexis user’s manual.
5.2.4 Combining model to 3D volume
A model can be combined to a 3D volume in the Romexis 3D module.
Opening 3D volume
See section "Opening images" in the Romexis user’s manual.
Importing intraoral scans to 3D volumes
See section "Importing 3D models" in the Romexis user’s manual.
5 Getting started
12 KaVo ProXam iOS Instructions for use

6 Scanner setup
This section describes how to prepare the scanner for scanning.
Components
The scanner comes with the following components:
KaVo ProXam iOS scanner
• Scanner tip x 3 (standard x 2, SlimLine x 1)
• Scanner cable x 2
• Standalone holder
• Colour balancer
• Cover boot x 4
6.1 Connecting scanner cable
Steps
1. Align the notch on the cable with the small notch on the back of the
scanner.
6 Scanner setup
Instructions for use KaVo ProXam iOS 13

2. Push the cable in and turn clockwise until the notch on the cable is
aligned with the larger notch.
NOTE
Keep the scanner connected to the cable at all times. Remove the
cable from the scanner only when directed by customer support or when
replacing the cable.
6.2 Plugging scanner into laptop
About this task
NOTE
Keep the scanner connected to the cable at all times. Remove the cable
from the scanner only when directed by customer support or when replacing
the cable.
Steps
1. Insert the USB cable into a USB 3 port on the laptop.
Refer to your laptop's user's manual to find the USB 3 port.
6 Scanner setup
14 KaVo ProXam iOS Instructions for use