HERON IOS User manual

A Digital Impression Scanner Solution
User Manual

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Table of Contents
Table of Contents ...................................................................................2
1. Introducing the Heron™ IOS Solution............................................5
1.1. Introduction ................................................................................5
1.2 Indications supported ...............................................................5
1.3 Certification and compliance...................................................5
1.4 Regulatory ....................................................................................6
1.5 Intended Use................................................................................6
1.6 Classifications..............................................................................6
2. What’s in the Box................................................................................7
3. System Requirements and Specifications....................................8
3.1 System Specifications................................................................8
3.1.1 Scanner.................................................................................8
3.1.2 Scanning Process ...............................................................8
3.1.3 Software & Lab Integration...............................................9
3.2 Computer Requirements...........................................................9
3.2.1 Required Software and Misc. ...........................................9
3.2.2 Required Hardware ............................................................9
3.3 Environment Conditions ........................................................ 10
3.4 Power Input............................................................................... 10
3.5 Reusable Tips............................................................................ 10
3.6 Scanner –Base and Handpiece............................................ 10
4. How to Connect & Set up the Heron™ IOS Solution ..................... 11
4.1 Setting Up and Connecting the Heron™ IOS ..................... 11
4.2 Heron™ IOS Components Overview .................................... 13
4.3 Settings....................................................................................... 13

5. Operating the Heron™ IOS Solution ............................................15
5.1 Getting Started..........................................................................15
5.1.1 Case Management Software Overview.............................15
5.2 Indication workflows ...............................................................16
5.2.1 Create new order..............................................................16
1.2.2 Choose material and color ............................................18
5.3. Important things to know before scanning.......................19
5.4 Operating the scanner.............................................................20
5.4.2 Mandibular and Maxillary Scanning.............................21
5.4.3 Bite Alignment...................................................................22
5.4.4 Tip........................................................................................23
5.5 Communication with the Lab................................................24
5.6 Scanning Tools .........................................................................25
5.7 Editing Tools.....................................................................26
6. Understanding the Software Symbols..................................27
7. Maintenance .....................................................................................28
7.1 Cleaning the Handpiece..........................................................28
7.2 Cleaning and Sterilization of Tip...........................................28
7.3 Disposal ......................................................................................30
7.4 Calibration..................................................................................30
8. Safety Guidelines and Warnings...................................................32
8.1 Warnings and Symbols............................................................32
8.2 General Guidelines ...................................................................32
8.3 General Warnings .....................................................................33
8.3.1 System Modification........................................................33
8.3.2 Approved Software ..........................................................33
8.3.3 Equipment Failure............................................................33
8.4 Mechanical Hazards.................................................................33

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8.4.1 Moving Parts ..................................................................... 33
8.4.2 Dropped Equipment ....................................................... 34
8.4.3 Base .................................................................................... 34
8.5 Electrical Safety........................................................................ 34
8.5.1 Electrical Shock................................................................ 34
8.5.2 Stress on Cables............................................................... 34
8.6 Eye Safety................................................................................... 35
8.7 Hygiene ...................................................................................... 35
8.8 During Systems Operation..................................................... 35
8.9 Symbols on the Heron and Transport Case....................... 36
9. Support, Warranty and Repair Service ................................. 37
9.1 Support ...................................................................................... 37
9.2 Standard Warranty .................................................................. 37
9.3 Repair Service ........................................................................... 37
9.4 Out of Warranty Repair Service............................................. 38
9.5 Troubleshooting Guide........................................................... 38

1. Introducing the Heron™ IOS Solution
1.1. Introduction
Thank you for purchasing the Heron™ IOS solution from 3DISC.
The Heron™ IOS solution is designed and developed to produce high-
quality digital intraoral scans, or models, for dental restoration or
analysis.
The Heron™ IOS solution is designed with you as a dentist and your
patient in mind. The scanner is lightweight, small and easy to use,
enabling a fast, accurate scanning and great patient experience. The
Case management application is order management as you know it
and designed for easy and intuitive use. Enjoy your new intraoral
scanner solution!
1.2 Indications supported
Heron™ IOS can be used for the following indications:
•Anatomy crowns
•Copings
•Provisional (Temporary) crowns
•Pontics (Anatomical, reduced and provisional)
•Inlays/Onlays
•Veneers
•Wax up (anatomical and reduced)
•Implants (Single abutments)
•3-unit Implant bridges
•Up to 5-unit bridges
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

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1.4 Regulatory
The Heron™ IOS is manufactured and marketed in accordance with US
FDA Regulations and EU Medical Device Directive 93-42-EEC.
1.5 Intended Use
The Heron™ IOS 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.
CAUTION: Federal law restricts this device to be sold by or on the
order of a Dentist.
WARNING: Unintended use of the system can result in physical injury
to the patient and operator, and damage to the system.
1.6 Classifications
The Heron™ IOS 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.

2. What’s in the Box
The Heron™ IOS system includes the following:
Save the Box: It is highly recommended that you store the box in a safe
place and do not throw it away. The box is optimal for any necessary
transportation or shipment of the Heron™ IOS.
Name
Part Number
Heron™ IOS System (Includes 3 Tips)
IOS-FP-71-001
USB 3.0 Cable
IOS-CP-00-043
AC/DC Power Adapter
IOS-CP-00-088
Software Licensing Dongle, QuantorClinic™
IOS-CE-71-013
Software Licensing Dongle
(Case management software only, no CAD)
IOS-CE-71-016
Quick Guide
IOS-FPM-71-002

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3. System Requirements and Specifications
3.1 System Specifications
3.1.1 Scanner
3.1.2 Scanning Process
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
Power Requirement
DC5.0V / 4A (Power supply included)
Scanner Tip
Reusable, sterilize using steam autoclave
Heating Element
Prevents formation of fog on the optics
Acquisition Method
Intraoral camera –active stereo imaging
Color Scanning
24-bit (8-bit per channel)
Tooth Preparation
No powder or spray required
Scanning Principle
Continuously scanning and accumulating
(stitching) depth and color data
Distance Scanner - Tooth
0 –12mm
Possible contact duration by
operator
10 min ≤ t
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 & Lab Integration
3.2 Computer Requirements
3.2.1 Required Software and Misc.
3.2.2 Required Hardware
NOTE: AMD GPU’s are NOT compatible with the Heron™ IOS. Not
meeting minimum hardware requirements will affect the
performance of the scanner.
Output File Format
STL, PLY, OBJ
Compatibility with CAD/CAM Systems
Open Architecture
Output format STL, PLY, OBJ
Compatible with most Dental CAD
systems
Case Management application Interface
Touchscreen support
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)
2 x USB port
CPU Type
Intel i7 - 4 Cores or greater (e.g. i7 8700)
CPU Clock
2.8 GHz clock or greater
Memory
16 GB of RAM or greater (DDR4 or better)
GPU
NVIDIA GeForce Graphics Processor000 Series (GTX): 1070 or
Greater
1000 Series (GTX): 1070 or greater - At least 6 GB video memory
2000 Series (RTX): 2060 or greater - At least 6 GB video memory

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3.3 Environment Conditions
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 50 times in a steam autoclave. See
chapter 6.
3.6 Scanner –Base and Handpiece
The scanner body consists of the Base and Handpiece, which are
connected by a flexible, non-detachable cable.
Operating Temperature
10°C ~ 40°C
Operating Relative Humidity
10% ~ 80% (non-condensing)
Storage Temperature
- 20°C ~ 60°C
Storage Relative Humidity
10% ~ 80% (non-condensing)
Indoor use only
Installation Category
1
Pollution Degree
2
Ingress of Liquids
IPXO
Protective Class
Class IIIb
Overvoltage category
I (Supplied from output DC source, max. 5
Vdc, 600 mA) of notebook or non-medical
grade PC certified by IEC60950-1
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 if there is a problem.
Cleaning
Do not try to clean the inside of the device.
Refer to Chapter 6 for cleaning and
sterilization.

4. How to Connect & Set up the Heron™ IOS Solution
4.1 Setting Up and Connecting the Heron™ IOS
Connection Guide
Plug in the two USB
software dongles (Gray
and Blue).
USB 3.0 Cable
Heron™ IOS
AC/DC PowerAdapter
Install the system according to the following steps:
Step 1: Place the base on a flat, stable surface and place
the Heron™ IOS handpiece securely in its base.
Step 2: Connect the AC/DC power adapter cable to the Base; the
connector socket is located underneath the Base.
Step 3: Connect the provided USB 3.0 cable to the Base;
the connector socket is located underneath the Base.
Step 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 reduced performance.

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Step 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 following symbol: ;
not doing so may result system malfunction or reduced
performance.
If using a laptop computer, make sure the power supply is
connected to an outlet and not running on battery power.
WARNING: Unsuitable Installation sites
• Locations with excessive humidity or dust
• Locations subject to high temperature
• Locations subject to shaking or vibration
• Locations exposed to considerable electrical or magnetic
noise, or other forms of electromagnetic energy

4.2 Heron™ IOS Components Overview
Please review the Heron™ IOS features shown in this section. This will
help you locate the features when they are described in sections 5-7.
4.3 Settings
After starting the QuantorClinic™ software, you can access the settings
menu, that contains the following options:
1
The base and scanner
2
Tip
3
Scan Button
4
Handpiece
5
USB 3.0 Cable
6
AC/DC Power Adapter

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User Interface Language
This function allows you to set your language preference. The system is
available in the following languages:
English
French
German
Greek
Italian
Japanese
Korean
Portuguese
Russian
Spanish
Turkish
Dental Numbering Systems
This setting allows you to select the tooth numbering system of your
preference.
The following numbering systems are available:
•FDI World Dental Federation notation
•Universal numbering system
•Palmer notation
Dentalshare Mode
•Enable
•Disable
•LAN client connection
•Toggle on-off full list of indications
•Extension management

5. Operating the Heron™ IOS Solution
5.1 Getting Started
5.1.1 Case Management Software Overview
A. Patient Information
The case management screen is used to record patient
information and to create notes for your lab. Patient name and
RX notes can be filled out in the ‘Project’ Section (A), or a returning
patient can be selected from the ‘Load’ tab.
B. Job definition
The ‘Job Definition’section (B) is used to record your desired
restoration and to indicate whether a single arch scan and/or a
bite alignment is needed.
C. Procedure
The ‘Actions’ section (C) is used to begin your scan, export scan
files to your lab using ‘dentalshare’ or to print a pdf of the patient
RX form.
Figure 1

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5.2 Indication workflows
QuantorClinic™ supports the following restorations and appliances:
5.2.1 Create new order
To create a new patient order for the above-mentioned indications, follow
the steps below.
Anatomic crowns
Copings
Provisional crowns
Anatomical pontics
Reduced pontics
Provisional pontics
Inlays/Onlays
Implant abutments
3-unit implant bridges
Up to 5-unit bridges
Orthodontic aligners
Nightguards
Splints
Retainers
Bleach trays
Sleep appliances

1. Start the Case
management
application, called
QuantorClinic™.
2. Click on the ‘New’
tab (Figure 1: A).
3. Enter a new patient
or select an existing
patient under the
“load” tab.
4. In the ‘Job
Definition’section
(Figure 1B) select the
desired tooth/teeth
for restoration.
5. Once you have
selected your tooth
a library of
procedures will
appear. Select the
needed restoration
from the list.

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1.2.2 Choose material and color
2. Customize your
parameters or keep them
on the default setting.
3. Click ‘OK’ to confirm
selection.
1. You may choose your
preferred material;
however, this selection is
optional and not required
as your lab will likely
make this decision.

4. If a bite registration is
needed, you must select
a tooth on the opposing
arch, labeling it as an
‘antagonist’.
5. If you want to create a
bridge connection, click
on a second tooth/teeth
and then click on the
small green circle to
connect them.
6. Save order
7. Start scanning
5.3. Important things to know before scanning
If doing a crown, prepare the tooth with a gingiva retraction cord. This
is optional however highly recommended. Prior to scanning, remove
the retraction cord and dry the surface of any blood or saliva using an
air/water syringe or a 2x2 gauze.