Dentsply Sirona Primescan Connect User manual

New as of:
2022-09
Primescan Connect
Operating Instructions (not valid for USA)
English

Table of Contents Dentsply Sirona
Operating Instructions Primescan Connect
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Table of Contents
1General data ................................................................................................... 5
1.1 Dear Customer,............................................................................................................ 5
1.2 Contact information...................................................................................................... 5
1.3 General information about these operating instructions............................................... 6
1.3.1 Notes to the repository .................................................................................. 6
1.4 General conventions and structure of the document ................................................... 7
1.4.1 Structure of the document ............................................................................. 7
1.4.1.1 Identification of danger levels ...................................................... 7
1.4.1.2 Formats and symbols used.......................................................... 7
1.4.2 Operating conventions .................................................................................. 8
1.5 Warranty and liability.................................................................................................... 8
1.6 Intended use ................................................................................................................ 9
1.7 Legend ......................................................................................................................... 10
2Safety instructions........................................................................................... 12
2.1 Basic safety information............................................................................................... 12
2.1.1 Prerequisites ................................................................................................. 12
2.1.2 Connecting the unit ....................................................................................... 12
2.1.3 General safety information ............................................................................ 12
2.1.4 Transporting the scanner .............................................................................. 14
2.1.5 Stability of the unit ......................................................................................... 14
2.1.6 Maintenance and repair................................................................................. 15
2.1.7 Modifications to the product .......................................................................... 15
2.1.8 Accessories ................................................................................................... 15
2.2 Electrostatic charge...................................................................................................... 15
2.2.1 ESD warning labels ....................................................................................... 15
2.2.2 ESD protective measures.............................................................................. 15
2.2.3 About the physics of electrostatic charges .................................................... 16
2.3 Wireless phone interference with equipment ............................................................... 17
2.4 Integrating the laptop in the network............................................................................ 18
2.5 Disposal ....................................................................................................................... 18
3Product description ......................................................................................... 19
3.1 Technical description ................................................................................................... 19
3.2 Technical data.............................................................................................................. 20
3.3 Major components........................................................................................................ 21
3.4 Controls and functional elements................................................................................. 21
3.4.1 Overview ....................................................................................................... 21
3.4.2 Coupling box ................................................................................................. 22
3.5 Certification .................................................................................................................. 23

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Operating Instructions Primescan Connect
Table of Contents
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3.6 Electromagnetic compatibility....................................................................................... 24
3.6.1 Electromagnetic emission ............................................................................. 24
3.6.2 Interference immunity.................................................................................... 25
3.6.3 Working clearances....................................................................................... 28
4Installation and commissioning ....................................................................... 29
4.1 Transport and unpacking ............................................................................................. 29
4.2 Disposal of packaging materials .................................................................................. 29
4.3 Scope of supply............................................................................................................ 29
4.4 Initial startup................................................................................................................. 29
4.4.1 Plug connections ........................................................................................... 30
4.4.2 Switching the units on ................................................................................... 33
4.4.3 Switching the units off ................................................................................... 34
5Operation ........................................................................................................ 35
5.1 Optical impressions with the scanner........................................................................... 35
5.2 Scanner guide.............................................................................................................. 38
5.2.1 Occlusal scan ................................................................................................ 39
5.2.2 Buccal scan ................................................................................................... 39
5.2.3 Lingual scan .................................................................................................. 40
5.2.4 Approximal surface scan ............................................................................... 40
5.2.5 Single and multiple buccal registration.......................................................... 41
5.2.6 Square and full jaw scan ............................................................................... 42
5.2.7 Scan strategy for edentulous cases .............................................................. 44
5.2.8 Concluding the optical impressions............................................................... 44
5.3 Software for the scanner.............................................................................................. 45
5.3.1 Cut out model areas ...................................................................................... 45
6Maintenance.................................................................................................... 46
6.1 Cleaning, disinfection, and sterilization........................................................................ 47
6.1.1 Cleaning agents and disinfectants ................................................................ 47
6.1.1.1 Cleaning agents........................................................................... 47
6.1.1.2 Wipe disinfectants (virucidal limited)............................................ 47
6.1.1.3 High-level disinfectant.................................................................. 47
6.1.2 Non-critical surfaces...................................................................................... 48
6.1.3 Scanner ......................................................................................................... 49
6.1.3.1 General information ..................................................................... 50
6.1.3.2 Components of the scanner......................................................... 51
6.1.3.3 Removing the sleeve ................................................................... 52
6.1.3.4 Attaching the sleeve .................................................................... 52
6.1.3.5 Preliminary cleaning of the sleeve............................................... 52
6.1.3.6 Wipe disinfection of the scanner and window sleeve .................. 53
6.1.3.7 High-level disinfection of the window sleeve ............................... 54

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Operating Instructions Primescan Connect
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6.1.3.8 Hot air sterilization of the window sleeve..................................... 59
6.1.3.9 Using disposable sleeves ............................................................ 60
6.1.3.10 Sterilizing autoclavable sleeves in the autoclave and using
disposable windows..................................................................... 61
6.1.4 Cleaning the inside of the sleeve window ..................................................... 63
6.2 Calibrating the scanner ................................................................................................ 64
6.3 Color calibration ........................................................................................................... 67
6.4 Replacing the O-ring .................................................................................................... 70
7Disposal .......................................................................................................... 72
8Appendix ......................................................................................................... 74
8.1 Making backup copies.................................................................................................. 74
Index ............................................................................................................... 75

Dentsply Sirona
Operating Instructions Primescan Connect
1 General data
1.1 Dear Customer,
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1General data
1.1 Dear Customer,
Thank you for your purchase of this Primescan Connect® unit from
Dentsply Sirona.
Primescan Connect allows you to send digital scans to a laboratory of
your choice for manufacture at your laboratory partner.
Improper use and handling can create hazards and cause damage.
Please therefore read and follow these operating instructions carefully.
Always keep them within easy reach.
Also pay attention to the safety instructions to prevent personal injury
and material damage.
Your
Dentsply Sirona team,
1.2 Contact information
Dentsply Sirona Product service Log in to register your units and make service requests:
https://dentsplysirona.service-pacemaker.com/
Manufacturer's address Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: +49(0) 6251/16-0
Fax: +49(0) 6251/16-2591
E-Mail: [email protected]
www.dentsplysirona.com

1 General data
1.3 General information about these operating instructions
Dentsply Sirona
Operating Instructions Primescan Connect
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1.3 General information about these operating
instructions
Follow the instructions for use Please familiarize yourself with the unit by reading through these
instructions for use before putting it into operation. It is essential that
you comply with the warning and safety information listed.
Always keep the operating instructions handy in case you or another
user require(s) information at a later point in time. Print out the
operating instructions and note where they are stored on the unit or
online.
If you sell the unit, make sure that the operating instructions are
included with it either as a hard copy or on an electronic storage device
so that the new owner can familiarize himself with its functions and the
specified warning and safety information.
"Download Center" for technical
documents
We have set up a "Download Center" or the technical documents at
dentsplysirona.com/ifu. From here, you can download these instructions
for use along with other documents. Please complete the online form if
you would like a hard copy of the instructions for use or operator's
manual. We would be happy to send you a printed copy, free of charge.
Help If you continue to have difficulties despite having thoroughly studied the
operating instructions, please contact your dealer.
Original language Original language of the present document: German
1.3.1 Notes to the repository
It is mandatory to keep this operating manual in an easily accessible
place for the purpose of later reference. In the event of a sale or transfer
of the device to another user, make sure that the device is supplied
along with the operating manual, so that the new owner can get
acquainted with the operation and the appropriate precautions and
warnings

Dentsply Sirona
Operating Instructions Primescan Connect
1 General data
1.4 General conventions and structure of the document
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1.4 General conventions and structure of the
document
1.4.1 Structure of the document
1.4.1.1 Identification of danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in these operating instructions.
Such information is highlighted as follows:
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily
injury or death.
CAUTION
A possibly dangerous situation that could result in minor or moderate
bodily injury.
NOTE
A possibly harmful situation which could lead to damage of the
product or an object in its environment.
IMPORTANT
Application instructions and other important information.
Tip: Information on making work easier.
1.4.1.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢ Individual action step
Request for action.
see “Formats and symbols used
[→7]”
Identifies a reference to another
text passage and specifies its
page number.
● List Identifies a list.
"Command / menu item" Indicates commands, menu items
or quotations.

1 General data
1.5 Warranty and liability
Dentsply Sirona
Operating Instructions Primescan Connect
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1.4.2 Operating conventions
Example Meaning
Click A single click down and releasing of the left
mouse button.
Double-click Clicking and releasing of the left mouse button
twice in quick succession.
Move the mouse
in one direction
Moving the mouse on the surface in the corre-
sponding direction.
"Ctrl+N" On the keyboard: Press the Ctrl and N keys si-
multaneously.
1.5 Warranty and liability
Maintenance In the interest of the safety and health of patients, users or third parties,
it is necessary that maintenance work is carried out at fixed time
intervals to ensure the operational safety and reliability of your product.
The operator must ensure the implementation of the maintenance work.
As a manufacturer of electro-medical equipment, we can consider
ourselves responsible for the safety characteristics of the device only if
maintenance and repairs are carried out only by us or by companies
authorized explicitly by us for this purpose and if components are
replaced with original spare parts in case of failure.
Exclusion of liability If the operator does not meet the obligation to carry out such
maintenance or fault messages are ignored, Dentsply Sirona or its
authorized dealer does not assume any liability for damage caused.

Dentsply Sirona
Operating Instructions Primescan Connect
1 General data
1.6 Intended use
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1.6 Intended use
The Primescan Connect acquisition unit creates digital impressions for
dental purposes. The unit may be operated only by medically trained
and qualified personnel.
This unit must not be used for any other purpose. If the unit is used for
any purpose other than the one mentioned above, it may be damaged.
The system may only be used in conjunction with the Primescan
intraoral scanner intended and approved for this purpose.
Intended use also includes compliance with these Operating
Instructions and the relevant maintenance instructions.
CAUTION
Follow the instructions
If the instructions for operating the unit described in this document are
not observed, the intended protection of the user may be impaired.

1 General data
1.7 Legend
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1.7 Legend
20XX
Year of manufacture
Safety labels
Identifies labels/imprints on the unit (see "Safety labels").
Product disposal symbol (see "Disposal [→72]").
Follow the operating instructions.
To ensure safe operation of the unit, the user must follow the operat-
ing instructions.
This product is intended for single use only
This product is a medical device.

Dentsply Sirona
Operating Instructions Primescan Connect
1 General data
1.7 Legend
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Symbols on the packaging
Take note of the following symbols on the packaging:
Up
Keep dry
Fragile; handle with care
Temperature during storage and transport
Relative humidity during storage and transport
Air pressure during storage and transport
Electronic Instructions for use
You can easily download the instructions for use from https://
www.dentsplysirona.com/ifu.

2 Safety instructions
2.1 Basic safety information
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Operating Instructions Primescan Connect
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2Safety instructions
2.1 Basic safety information
2.1.1 Prerequisites
NOTE
Important information on building installation
In order to prevent the risk of an electric shock, this unit must only be
connected to a supply mains with a ground wire.
The building installation must be performed by a qualified expert in
compliance with the national regulations.
NOTE
Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion
hazards.
NOTE
Do not damage the unit!
The unit can be damaged if opened improperly.
It is expressly prohibited to open the unit with tools!
2.1.2 Connecting the unit
Perform connection by following the directions given in the present
operating instructions.
2.1.3 General safety information
CAUTION
Risk group 2: Potentially hazardous optical radiation!
Direct radiation to the eye can be harmful to the eye.
➢ During operation, do not look directly at the lamp for long periods.
CAUTION
Note on the prevention, recognition, and elimination of unintended
electromagnetic effects:
The Primescan Connect acquisition unit is Class B equipment
(classified according to CISPR 11, EN60601-1-2: 2015 based on IEC
60601-1-2: 2014).
This unit may be used in professional equipment of health services.
NOTE
Install only approved software
To prevent interference with the runtime reliability of the program,
only software approved by Dentsply Sirona may be installed.

Dentsply Sirona
Operating Instructions Primescan Connect
2 Safety instructions
2.1 Basic safety information
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WARNING
Danger of touching live parts
If the housing is damaged, there is a possibility of touching live parts
inside the unit.
➢ Check that the unit is intact. The unit can only be used for work
purposes if it is intact.
➢ If the housing is damaged, the unit must be put and left out of
operation until it has been professionally repaired.
CAUTION
Restoration to be checked by trained personnel
Each restoration created must be checked for suitability by a trained
person (e.g. dentist).
IMPORTANT
Immediately notify the manufacturer and the national competent
authority of any serious incident that has occurred with the product.
Plug connections of external PC interfaces
CAUTION
Additional devices connected to external interfaces must be tested
according to the relevant standards, e.g.:
EN 60601-1:2006 + Cor.:2010 + A1:2013,
IEC 60601-1 Edition 3.1:2012,
EN 61010-1:2010 based on IEC 61010-1:2010 + Cor.:2011.
They must be installed outside of the patient area (a radius of 1.5m
surrounding the patient).
CAUTION
Low voltages are applied to the coupling box for connecting external
interfaces.
➢ Do not touch the pins of the connectors.
NOTE
The externally connected cables must not be subjected to pulling
stress.
CAUTION
Trip/fall hazard
The installation of the supply cable (cable between the coupling box
and the scanner) may result in a trip hazard.
➢ Lay the cable so that there is no risk of tripping.
➢ Attach the supply line so that it remains fixed at all times.
CAUTION
To maintain electrical safety, the laptop must not be operated within
the patient area (1.5 m around the patient).

2 Safety instructions
2.1 Basic safety information
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2.1.4 Transporting the scanner
CAUTION
Trip/fall hazard
When transporting the scanner, you may trip over the cable and fall.
➢ Ensure that the free cable ends are coiled when transporting the
scanner.
The scanner can be detached from the coupling box for use in different
treatment rooms.
2.1.5 Stability of the unit
NOTE
The Primescan Connect device could slip and fall off the table
Ensure that you place the holder with the scanner and the coupling
box on a flat surface. The oval plate on which the scanner holder is
mounted is equipped with non-slip feet to help prevent movement.

Dentsply Sirona
Operating Instructions Primescan Connect
2 Safety instructions
2.2 Electrostatic charge
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2.1.6 Maintenance and repair
As manufacturers of dental instruments and laboratory equipment, we
can assume responsibility for the safety properties of the unit only if the
following points are observed:
● The maintenance and repair of this unit may be performed only by
Dentsply Sirona or by agencies authorized by Dentsply Sirona.
● Components which have failed and influence the safety of the unit
must be replaced with original (OEM) spare parts.
● Only original cables may be used, so that EMC requirements are
met.
Please request a certificate whenever you have such work performed. It
should include:
● The type and scope of work.
● Any changes made in the rated parameters or working range.
● Date, name of company and signature.
2.1.7 Modifications to the product
Modifications to this product which might affect the safety of the system
owner, patients or other persons are prohibited by law!
2.1.8 Accessories
In order to ensure product safety, this device may be operated only with
original Dentsply Sirona accessories or third-party accessories
expressly approved by Dentsply Sirona. In particular, only the power
cable also supplied or the corresponding original spare part may be
used with the unit. The user is responsible for any damage resulting
from the use of non-approved accessories.
2.2 Electrostatic charge
2.2.1 ESD warning labels
ESD warning label CAUTION
Risk of injury or damage to components from electrostatic discharge
For electrical components labeled with an ESD warning label,
observe the following instructions.
➢ Apply the ESD protective measures.
➢ Do not touch connector pins or sockets without applying ESD
protective measures first.
➢ Do not establish any connections between these connectors
without applying ESD protective measures first.
2.2.2 ESD protective measures
ESD ESD stands for ElectroStatic Discharge.

2 Safety instructions
2.2 Electrostatic charge
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ESD protective measures ESD protective measures include:
● Procedures for preventing electrostatic charge build-up (e.g. air
conditioning, air moistening, conductive floor coverings and non-
synthetic clothing)
● Discharging the electrostatic charges of your own body on the frame
of the UNIT, the protective ground wire or large metallic objects
● Connecting yourself to ground using a wrist band.
Training We therefore recommend that all persons working with this system be
instructed on the significance of this warning label. Furthermore, they
also should receive training in the physics of electrostatic discharges
which can occur in the practice and the destruction of electronic
components which may result if such components are touched by
electrostatically charged USERS.
The content of this training is explained in the Chapter "About the
physics of electrostatic charges".
2.2.3 About the physics of electrostatic charges
What is an electrostatic charge? An electrostatic charge is a voltage field on and in an object (e.g. a
human body) which is protected against conductance to ground
potential by a nonconductive layer (e.g. a shoe sole).
Formation of an electrostatic charge Electrostatic charges generally build up whenever two bodies are
rubbed against each other, e.g. when walking (shoe soles against the
floor) or driving a vehicle (tires against the street pavement).
Amount of charge The amount of charge depends on several factors:
Thus the charge is higher in an environment with low air humidity than
in one with high air humidity; it is also higher with synthetic materials
than with natural materials (clothing, floor coverings).
Electrostatic discharge must be preceded by electrostatic charging.
The following rule of thumb can be applied to assess the transient
voltages resulting from an electrostatic discharge.
An electrostatic discharge is:
● perceptible at 3000 V or higher
● audible at 5000 V or higher (cracking, crackling)
● visible at 10000 V or higher (arc-over)
The transient currents resulting from these discharges have a
magnitude of 10 amperes. They are not hazardous for humans because
they last for only several nanoseconds.
Background Integrated circuits (logical circuits and microprocessors) are used to
implement a wide variety of functions in dental/X-ray/CAD/CAM
systems.
The circuits must be miniaturized to a very high degree in order to
include as many functions as possible on these chips. This leads to
structure thicknesses as low as a few ten thousandths of a millimeter.

Dentsply Sirona
Operating Instructions Primescan Connect
2 Safety instructions
2.3 Wireless phone interference with equipment
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It is obvious that integrated circuits which are connected to plugs
leading outside of the unit via cables are sensitive to electrostatic
discharge.
Even voltages which are imperceptible to the user can cause
breakdown of the structures, thus leading to a discharge current which
melts the chip in the affected areas. Damage to individual integrated
circuits may cause malfunction or failure of the system.
2.3 Wireless phone interference with equipment
The use of mobile wireless phones in practice or hospital environments
must be prohibited to ensure safe operation of the unit.

2 Safety instructions
2.4 Integrating the laptop in the network
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2.4 Integrating the laptop in the network
NOTE
Observe the following installation instructions
The following installation instructions apply when integrating the
laptop into a network:
Network
The laptop can be connected to a network via WiFi or LAN. When using
LAN, ground must be provided via an additional protective conductor.
Cross-section of the protective
conductor
in a protected instal-
lation
2.5mm2
laid unprotected 4 mm2
2.5 Disposal
On the basis of the Directive 2012/19/EU and the country-specific
disposal regulations on waste electrical and electronic equipment, we
would like to stress that such equipment must be disposed of
accordingly within the European Union (EU). These regulations demand
environmentally friendly recycling / disposal of waste electrical and
electronic equipment. These parts must not be disposed of as domestic
refuse. This has been symbolized by the symbol of the crossed out
garbage bin.
Please observe the disposal regulations applicable in your country.

Dentsply Sirona
Operating Instructions Primescan Connect
3 Product description
3.1 Technical description
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3Product description
3.1 Technical description
CAD system for high-precision intraoral optical impressions
● High-resolution, heated oral scanner (3D scanner) with removable
reflective sleeve
● Integrated image processing
● Coupling box, including interfaces
● Scanner holder
High-resolution 3D intraoral scanner with control and image
processing electronics
● Image acquisition: Image control inside the scanner
● Image data transfer: USB 2.0 standard
No water or air connection required.

3 Product description
3.2 Technical data
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Operating Instructions Primescan Connect
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3.2 Technical data
Type designation Primescan Connect
Rated line voltage 100-240 V ~ / 50-60Hz
Nominal current 1.0 – 0.6 A
Type of protection against electric shock Class I unit
Type of protection against electric shock
(scanner)
Type BF applied part
Degree of protection against ingress of
water
Ordinary device (without
protection against ingress
of water)
Degree of contamination 2
Installation category Ⅱ
Operating mode Continuous operation
Transportation and storage conditions
In the original transport packaging, the acquisition unit withstands the
following environmental conditions during transport and storage:
Temperature -25°C to 60°C
(-13°F to 140°F)
Relative humidity 10% to 75%
Air pressure 700 hPa to 1060 hPa
Operating conditions
The acquisition unit may be operated in the following environmental
conditions:
Ambient temperature 10°C to 35°C
(50°F to 95°F)
Relative humidity 30% to 85%
No condensation
Air pressure 700 hPa to 1060 hPa
Operating altitude ≤ 3000 m