Whip Mix VeriPulse IOS User manual

User Manual

VeriPulse IOS User Manual
Precision you expected.
Simplicity you didn’t.

VeriPulse IOS User Manual
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1. Introducing the VeriPulse IOS
1.1. Introduction............................................................. 5
1.2 Indications Supported ................................................... 5
1.3 Certification and Compliance............................................. 5
1.4 Regulatory .............................................................. 5
1.5 Intended Use............................................................ 6
1.6 Classifications ........................................................... 6
2. What’s in the Box
2.1 Components Overview................................................... 7
3. System Requirements and Specifications
3.1 System Specifications.................................................... 8
3.1.1 Scanner........................................................... 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 and Handpiece ....................................10
3.7 Calibration ..............................................................10
3.8 Wall Mount Installation Instructions (Optional) ............................. 11
4. Setting up the VeriPulse IOS Solution
4.1 Connecting VeriPulse IOS ................................................12
4.2 Launching WhipMixClinic ................................................13
4.2.1 Setting Up a WhipMixClinic User Account............................14
4.2.2 Connecting VeriPulse IOS to WhipMixCloud..........................14
4.3 Getting Started With WhipMixClinic.......................................15
4.4 Configuring WhipMixClinic Settings .......................................17
5. Using WhipMixClinic
5.1 Managing Patient Cases................................................. 23
5.2 The WhipMixClinic Scan Workflow ....................................... 24
5.3 Before You Scan........................................................ 28
5.3.1 Operating the Scanner ............................................ 28
5.3.2 Using the Scanner Tip ............................................. 29
5.3.3 The Scanning Live View ........................................... 29
5.3.4 Recommended Scan Workflow ....................................30
5.4.1 Scanning the Maxillary Arch ........................................31
5.4.2 Scanning the Mandibular Arch ..................................... 33
5.4.3 Trimming Scans ................................................... 34
5.4.4 Using the Quality Map Tool......................................... 34

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5.4.5 Bite Alignment ................................................... 34
5.4.6 Auto-Realignment .................................................37
5.4.7 Using Bite Alignment Tools ........................................ 38
5.4.8 Finalizing A Patient Case .......................................... 38
6. Communicating With Labs
6.1 Linking a WhipMixClinic account to WhipMixCloud ........................40
6.2 Configuring a Connection with a Lab in WhipMixCloud .....................41
6.3 Managing Case Details in WhipMixCloud ................................. 42
6.4 Configuring WhipMixCloud Settings ..................................... 43
6.5 Configuring Evident Hub Setting.........................................44
7. Maintenance
7.1 Cleaning the Handpiece................................................. 45
7.2 Cleaning and Sterilization of Tip ......................................... 46
7.3 Disposal ............................................................... 47
7.4 Calibration ............................................................. 47
8. Safety Guidelines and Warnings
8.1 Warnings and Symbols.................................................. 48
8.2 General Guidelines .....................................................48
8.3 General Warnings ...................................................... 48
8.3.1 System Modification .............................................. 48
8.3.2 Approved Software ............................................... 49
8.3.3 Equipment Failure ................................................ 49
8.4 Mechanical Hazards .................................................... 49
8.4.1 Moving Parts ..................................................... 49
8.4.2 Dropped Equipment .............................................. 49
8.4.3 Base ............................................................. 49
8.5 Electrical Safety ........................................................50
8.5.1 Electrical Shock .................................................. 50
8.5.2 Stress on Cables ..................................................50
8.6 Eye Safety .............................................................50
8.7 Hygiene ...............................................................50
8.8 During Systems Operation ...............................................51
8.9 EMC Guidance and Declaration ...........................................51
8.10 Symbols on the VeriPulse IOS and Transport Case......................... 55
9. Support, Warranty and Repair Service
9.1 Support ............................................................... 56
9.2 Standard Warranty ..................................................... 56
9.3 Repair Service...........................................................57
9.4 Out of Warranty Repair Service...........................................57

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1. Introducing the VeriPulse IOS
1.1 Introduction
Thank you for purchasing the VeriPulse IOS solution from Whip Mix. The VeriPulse IOS
solution is designed and developed to produce high-quality digital intraoral scans, or models,
for dental restoration or analysis.
The VeriPulse 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
The data sets from the VeriPulse IOS can be used for the following indications:
• Crown
• Coping
• Pontic
• Inlay/Onlay
• Veneer
• Post & Core
• Wax Up
• Abutment
• Anatomical Abutment
• Screw Retained Crown
• Indirect Bonding
• Clear Aligners
• Night Guard
• Maxillary Deprogrammer
• Maxillary Repositioning Splint
• Full Denture
• Removable Partial Denture (RPD)
• Flexi Denture
• Copy Denture
• Guided Surgery Planning
• Tooth Supported Guide
• Bone Supported Guide
• Smile Design
• Digital Model
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 VeriPulse IOS is manufactured and marketed in accordance with US FDA Regulations and
EU Medical Device Directive 93-42-EEC.

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1.5 Intended Use
The VeriPulse 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: Rx only - 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 VeriPulse 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.

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2. What’s in the Box
The VeriPulse IOS system includes the following:
Name Part Number
VeriPulse IOS System (Includes 3 Tips) 70675
USB 3.0 Cable 79278
AC/DC Power Adapter 79279
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
VeriPulse IOS.
2.1 Components Overview
The VeriPulse IOS 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

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3. System Requirements and Specifications
3.1 System Specifications
3.1.1 Scanner
Scanner Type Hand-held (chairside) scanner that creates
optical impressions for dental restorations
Design Compact, lightweight, ergonomic – designed
to be operated with little physical eort
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)
3.1.2 Scanning Process
Tooth Preparation No powder or spray required
Scanning Principle Continuously scanning and accumulating
(stitching) depth and color data
Distance Scanner - Tooth 0 – 16mm
Possible contact duration by operator <10 min. 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 (autoclavable)
Computer – Scanner Interface USB 3.0

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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 16 GB of RAM or greater (DDR4 or better)
GPU NVIDIA GeForce Graphics Processor 10 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
NOTE: AMD GPU’s are NOT compatible with the VeriPulse IOS.
Not meeting minimum hardware requirements will aect the
performance of the scanner.

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3.3 Environment Conditions
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 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 device.
Refer to section 7.1 Cleaning the Headpiece.
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 7.2 Cleaning and Sterilization of Tip.
3.6 Scanner Docking Base and Handpiece
The scanner body consists of the Base and Handpiece, which are connected by a flexible,
non-detachable cable.
3.7 Calibration
The VeriPulse IOS is factory calibrated. In the case of calibration issues due to transport,
please contact your reseller or Whip Mix support technician.