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