Vatech EzScan-i User manual

User Manual
Version 3.4

Document
Software Version
Date
EzScan
User Manual
IOS-FPM-71-007_EN_AA
3.4
11.10.2021
Comeandjointhegrowing
Vatech.co m

Introducing the EzScan.................................................5
1.1 Introduction................................................................................................................... 5
1.2 Indications supported.................................................................................................. 5
1.3 Certification andcompliance ....................................................................................... 5
1.4 Regulatory ................................................................................................................... 6
1.5 Intended Use ............................................................................................................... 6
1.6 Classifications .............................................................................................................. 6
2. What’s in theBox ......................................................7
2.1. Components Overview ......................................7
3. System Requirements and Specifications..................8
3.1 System Specifications .................................................................................................. 8
3.1.1 Scanner Specifications ...................................................................................... 8
3.1.2 Scanning Process ............................................................................................. 8
3.1.3 Software output and design software compatibility .................................... 9
3.2 Computer Requirements ............................................................................................. 9
3.3 Environment Conditions............................................................................................ 10
3.4 Power Input ............................................................................................................... 10
3.5 Reusable Tips ............................................................................................................ 10
3.6 Scanner Docking Base andHandpiece........................................................................ 11
3.7 Calibration ................................................................................................................. 11
3.8 Wall Mount Installation Instructions (Optional)........................................................ 11
4. Setting up the EzScan solution.................................12
4.1 Connecting EzScan..................................................................................................... 12
5. Getting Started With EzScan-i.................................14
5.2 Connecting EzScan To EzScanCloud........................................................................... 17
5.3 Configuring System Settings ...................................................................................... 18
5.4 Managing Patient Cases ............................................................................................ 24
5.5 The EzScan-i Workflow .............................................................................................. 26
6. Before You Scan......................................................30
6.1 Operating the Scanner............................................................................................... 30
6.2 Using the Scanner Tip................................................................................................ 31
6.3 The Scanning Live View ............................................................................................. 32
6.4 Default EzScan Workflow .......................................................................................... 33
6.4.1 Scanning the MaxillaryArch............................................................................ 33

6.4.2 Scanning the MandibularArch ........................................................................ 35
6.4.3 Trimmingscans.................................................................................................... 36
6.4.4 Using the Quality Map tool............................................................................. 36
6.4.5 Carrying Out A Bite Alignment........................................................................ 37
6.4.6 Auto-Realignment........................................................................................... 41
6.4.7 Using Bite Alignment Tools............................................................................. 42
6.4.8 Finalizing A Patient Case ................................................................................. 43
7. Communicating With Labs......................................46
7.1 Linking an EzScan-i account to EzScanCloud.............................................................. 46
7.2 Configuring a Connection with a Lab in EzScanCloud................................................ 48
7.3 Managing Case Details in EzScanCloud...................................................................... 49
7.4 Configuring EzScanCloud Settings ............................................................................. 50
8. Maintenance...........................................................52
8.1 Cleaning theHandpiece ............................................................................................. 52
8.2 Cleaning and Sterilization ofTip................................................................................. 52
8.3 Disposal ..................................................................................................................... 54
8.4 Calibration ................................................................................................................. 54
9. Safety Guidelines andWarnings..............................55
9.1 Warnings andSymbols............................................................................................... 55
9.2 General Guidelines .................................................................................................... 55
9.3 General Warnings ...................................................................................................... 56
9.3.1 System Modification ....................................................................................... 56
9.3.2 Approved Software ......................................................................................... 56
9.3.3 Equipment Failure........................................................................................... 56
9.4 Mechanical Hazards...................................................................................................... 56
9.4.1 Moving Parts ................................................................................................... 56
9.4.2 Dropped Equipment........................................................................................ 57
9.4.3 Base ................................................................................................................ 57
9.5 Electrical Safety.......................................................................................................... 57
9.5.1 Electrical Shock .............................................................................................. 57
9.5.2 Stress onCables .............................................................................................. 57
9.6 Eye Safety .................................................................................................................. 58
9.7 Hygiene...................................................................................................................... 58
9.8 During SystemsOperation ......................................................................................... 59
9.9 EMC Guidance and Declaration................................................................................. 59
10. Support, Warranty and RepairService ................66
10.1 Support................................................................................................................ 66
10.2 Standard Warranty .............................................................................................. 66
10.3 Repair Service ...................................................................................................... 67
10.4 Out of Warranty RepairService............................................................................ 67

Page 5
Introducing the EzScan
1.1 Introduction
Thank you for purchasing the EzScan solution from Vatech. The EzScan
solution is designed and developed to produce high-quality digital
intraoral scans or models, for dental restoration or analysis.
The EzScan solution is designed with you as a dentist and your patient in
mind. The scanner is lightweight, small and easy to use, enabling fast,
accurate scanning and great patient experience. The Case management
application provides efficient and customizable order management, for
easy and intuitive use. Enjoy your new intraoral scanner solution!
1.2 Indications supported
The data sets from the EzScan can be used for the following indications.
· Conventional crowns
· Anatomic crowns
· Copings
· Provisional crowns
· Anatomical pontics
· Reduced pontics
· Provisional pontics
· Inlays/Onlays
· Implant abutments
· 3-unit implant bridges
· Up to 5-unitbridges
· Orthodontic aligners
· Nightguards
· Splints
· Retainers
· Bleach trays
· Sleep appliances
· …
* Verify with your dental lab or service provider about their capabilities
to produce particular indications.
1.3 Certification and compliance
The system has been tested and conforms to the following standards:
• IEC 60601-1, Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
• IEC 60601-1-2, Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances
- Requirements and tests:
• IEC 62471, Photobiological safety of lamps and lamp systems

1.4 Regulatory
The EzScan is manufactured and marketed in accordance with US FDA
Regulations and EU Medical Device Regulation 2017/745.
1.5 Intended Use
The EzScan is an optical impression system. It is used to record the
topographical characteristics of teeth, dental impressions, or stone models
for use in the computer-aided design (CAD) and computer-aided
manufacturing (CAM) of dental restorative prosthetic devices.
1.6 Classifications
The EzScan system has the following classifications
•Protection against electrical shock: Type B Applied Part
•Protection against harmful ingress of water: Ordinary equipment
(IPX0)
•Safety of application in the presence of a flammable anesthetic
material with air or with oxygen or nitrous oxide: Equipment not
suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
WARNING: Unintended use of the system can result in physical injury
to the patient and operator, and damage to the system.
CAUTION: Rx only - Federal law restricts this device to be sold by or on
the order of aDentist.

Page 7
2. What’s in the Box
The EzScan system includes the following:
Name Part Number
Vatech System (Includes3 Tips) V2810110
USB 3.0 Cable IOS-CP-00-043
AC/DC Power Adapter IOS-CP-00-088
Save the Box: It is highly recommended that you store the box in a safe place and do
not dispose of it. The box is optimal for any necessary transportation or shipment of
the EzScan.
2.1. Components Overview
The EzScan comprises the following components:
1. Docking base
2. Tip
3. Scan Button
4. Scanner handpiece
5. USB 3.0 Cable
6. AC/DC Power Adapter

Page 8
User Manual
3. System Requirements and Specifications
3.1 System Specifications
3.1.1 Scanner Specifications
Scanner Type
Hand-held (chairside) scanner that creates
optical impressions for dental restorations.
Design
Compact, lightweight, ergonomic –designed
to be operated with little physical effort.
Dimensions Base
Size: L 306mm, W 98mm, H 72mm
Dimensions Scanner
Weight: 150 grams
Size: L 256mm, W 43mm, H 43mm
Cable length (scanner to base): 2m
Power Requirement
DC 5.0V / 4A (Power supply included)
Scanner Tip
Reusable up to 250 times, sterilize using steam
autoclave
Heating Element
Ventilated. Prevents formation of fog on optics
Acquisition Method/Imaging
technology
Hybrid technology: active stereo imaging and
structured light
Sensor technology
CMOS
Color Scanning
24-bit (8-bit per channel)
Scanning frequency
25-30 FPS
Imaging field-of-view
12mm x 14mm
Light sources
High-power LEDs
3.1.2 Scanning Process
Tooth Preparation
No powder or spray required
Scanning Principle
Continuously scanning and
accumulating (stitching) depth
and color data

Page 9
Distance Scanner - Tooth
0 –16mm
Possible contact duration by operator
<10min. Note: May vary with
hardware configuration
Operator accessible part
Handpiece
Possible contact duration by patient
10 min ≤ t
Patient accessible part (Type B Applied Part)
Tip
Computer –Scanner Interface
USB 3.0
3.1.3 Software output and design software compatibility
Output File Format
STL, PLY, OBJ
Compatibility with CAD/CAM
Systems
Open Architecture Output format STL, PLY, OBJ
Compatible with most Dental CAD systems
3.2 Computer Requirements
Required Software and Misc.
Operating System
Windows 10 (Excluding Windows 10 S, now
defunct) Administrative rights required
Disk Space
100 GB of free disk space or greater
Ports
1 x USB 3.0 port (SuperSpeed)
Required Hardware
CPU Type
Intel i7 - 4 Cores or greater (e.g. i7 8700)
CPU Clock
2.8 GHz clock or greater
Memory
16GB ofRAM or greater (DDR4 or better)
GPU
NVIDIAGeForceGraphics Processor 10 Series
(GTX):1070orGreater10 Series (GTX): 1070 or
greater - At least 6 GB video memory
RTX2000 Series: 2060 or greater - At least 6 GB
video memory
Quadro RTX3000 and above for laptop - At least 6
GB video memory

Page 10
User Manual
3.3 Environment Conditions
Operating Temperature
10°C to 40°C
Operating Relative Humidity
10% to 80% (non-condensing)
Storage Temperature
- 20°C to 60°C
Storage Relative Humidity
10% to 80% (non-condensing) Indoor use
only
Installation Category
1
Pollution Degree
2
Ingress of Liquids
IPXO
Protective Class
Class IIIb
Overvoltage category
II per IEC 60664-1
Max. working condition
Continuous cycles with image capture
and transmission from/to Notebook or
non-medical grade PC.
Other possible accessories (IEC60601-1
3rd, Cl. 16)
Notebook with AC/DC Adapter.
Equipment Maintenance
No user maintenance is required, and no
user service is allowed. Please contact
technical support in case of problem.
Cleaning
Do not try to clean the inside of the de-
vice. Refer to Chapter 6 for cleaning and
sterilization.
3.4 Power Input
The power adapter input is 5V DC, 100-240V AC, 50-60Hz.
3.5 Reusable Tips
Scanner tip is autoclavable up to 250 times in a steam autoclave when used with
132°C/134°C 4 mins cycle or 121°C 45 min cycle. See section 8.2 below.

Page 11
3.6 Scanner Docking Base andHandpiece
The scanner body consists of the Docking Base and Handpiece, which are
connected by a flexible, non-detachable cable.
3.7 Calibration
The EzScan™ intraoral scanner is factory calibrated. In the case of calibration issues
due to transport, please contact your reseller or Vatech support technician.
3.8 Wall Mount Installation Instructions (Optional)
When wall mounting the scanner’s base, be careful to respect measurements
indicated to drill holes for the wall mount.
•It is recommended to use wall anchors and threaded screws with an 8mm
(5/16th inch) head diameter.
•A 4-5mm (3/16th in) distance between wall and bottom screw head is
recommended.
Caution: If the docking base is not properly installed there is a
possibility of the base falling and damaging the scanner.
IMPORTANT: Vatech is not responsible for accidents or damage
caused in the event the scanner falls.

Page 12
User Manual
4. Setting up the EzScan solution
4.1 Connecting EzScan
Installing and connecting the EzScan solution
To install and connect the EzScan Scanner:
1. Place the docking base on a flat, stable surface and place the EzScan
handpiece securely on the base.
2. Connect the AC/DC power adapter cable to the dockingbase (the connector
socket is located underneath the base).
3. Connect the provided USB 3.0 cable to the docking base (the connector
socket is located underneath the base).
4. Connect the other end of the USB cable to the computer.
NOTE: Using a USB cable other than the one provided may result
in system malfunction or reducedperformance.

Page 13
5. Connect the AC/DC power adapter to a power outlet.
NOTE: It is strongly recommended to plug the USB cable
to a USB port located at the back of the computer; not
doing so may result in system malfunction or reduced
performance.
Make sure to use a USB port that is compatible with USB
3.0 (SuperSpeed), usually indicated by the symbol: not
doing so may result system malfunction or reduced
performance.
WARNING: Unsuitable installation sites:
Locations with excessive humidity ordust
Locations subject to hightemperature
Locations subject to shaking orvibration
Locations exposed to considerable electrical or
magnetic noise, or other forms of electromagnetic
energy
IMPORTANT: If using a laptop computer, make sure the power
supply is connected to an outlet and not running on battery power.
Failure to do so will mean that the scanner will not have sufficient
power to produce images.

Page 14
User Manual
5. Getting Started With EzScan-i
Once you have connected the EzScan, you are ready to launch the EzScan-i
software installed on your computer. The EzScan-i software is launched by
selecting the IO Scanner option in EzDent-i.
Case Setup
EzScan-i will open directly in the Case Setup window. The Case
Setup icon is highlighted in the left-hand menu:

Page 15
EzScan-i Homepage
To go to the EzScan-i homepage, click on the Home icon in the top
left corner of the Case Setup window.
Patients/Cases View
In the EzScan-i homepage, you can toggle
between Patients and Cases views, and Filter
or search desired Patients/Cases.
Filter/Search
You can search by term or Click on the Filter icon to open the Filters dialog
box.
Patients and cases can be filtered by Gender and/or Date.

Page 16
User Manual
5.1 Configuring EzScan-i User Settings
Before using the EzScan intraoral scanner, you can use the default EzScan-i
(administrator) account to configure your EzScan-i User account settings:
1. Click the System icon located in the top right-hand corner of
the EzScan-i homepage. This will open the Settings page.
2. Select Users in the left-hand Settings menu, and click on Add and Edit
Users.
Note: System settings are automatically applied to all users.
3. Select the default EzScan-i User profile, and
click on the Edit icon.
In Users settings you can Add or Edit Users,
and enter/modify User information: email,
name andphoto.
User dossiers can be password protected,
and linked to an EzScanCloud account.

Page 17
5.2 Connecting EzScan To EzScanCloud
The EzScan Solution enables users to connect to its dedicated cloud platform
EzScanCloud to easily and efficiently setup and manage file transfers and connections
with labs.
If you select Use EzScanCloud in the Add or Edit Users dialog box, the EzScanCloud
Login window will open automatically, inviting you to
1. Login:
2. Create a New Account:
For information on setting up an EzScanCloud User Account and Connection see below:

Page 18
User Manual
7. Communicating With Labs
To send orders from EzScan-i to labs via the EzScanCloud platform, you will have to:
1. Link your EzScan-i account to the EzScanCloud
2. Configure a connection with the lab in EzScanCloud
Note: In EzScan-i, you can also communicate directly with labs by exporting files to
your computer and transferring them via a third party platform.
6.1 Linking an EzScan-i account to EzScanCloud
Creating An EzScanCloud User Account
To link your EzScan-i account to the EzScanCloud :
1. Click on the System Settings icon in the EzScan-i Start screen.
2. In User system settings, click Add or Edit Users using the administrator
account (HC).
3. Select Use EzScanCloud in the Add or Edit Users dialog box.
The EzScanCloud Login window will open automatically, inviting you to
Login or to
Create a New Account.
4. ClickCreate New Account: in the dialog box Fill in the
required fields (marked with a red *) and click Create.
An email will be sent to confirm the email address.
Click the confirmation link to access the EzScanCloud Sign In page. Linking an
EzScan-i account to EzScanCloud.

Page 19
5.3 Configuring System Settings
To configure EzScan-i system settings, click the System icon located in the top right-hand
corner of the homepage.
Description
System Setting
Description
System Language
Select graphical interface language
Preferred Output Format
Select default 3D Output format: STL, PLY, OBJ
Picture Save Format
Select default image format: .PNG, .JPG
Preferred Start Page
Select Recent Patients or Recent Cases default
start page
Enable Colored ROI Overlay During
Bite Alignment
Select to display colored ROI overlay during Bite
Alignment. Activated by default. This triggers a
green/red overlay during scan phase to indicate
actively gather data.
Enable High-Resolution Finalization
Select to enable default high-resolution
finalization
View Software version
(copy function to right)
Select to view/copy scanning module software
version
UI Version
(copy function to right)
Select to view/copy user interface version
Check for Software Updates
Click Check Now button to manually check for
software updates. An automatic check is done at
launch
User Manual
Click to access User manual online
Teamviewer
Click to allow secure remote control of your
workstation by a Vatech support technician.
Support Page
Vatech support homepage.

Page 20
User Manual
Data Settings
Data settings enable you to specify Import and Export Database and Export Path
settings. You can also choose to share or restrict access to the Database.
Description
Data Setting
Description
Export Database
Click on the EXPORT button to select the EzScan-i
Data folder and Export folder, and to export All
or Selected Cases
Import Database
Click on the IMPORT button to select the EzScan-i
Data folder and Import folder, and to import All
or Selected Cases
Case Export Path
Click to specify the Case Export folder
Share Database With All Users
Activate this feature to share or restrict Database
access
Export Database
Click on the EXPORT button to select the EzScan-i Data
folder and Export folder. You can export All or
Selected Cases.