Dentsply Sirona CEREC Primescan AC User manual

New as of: 09.2019
CEREC Primescan AC,
Primescan AC
Operating Instructions (not valid for USA)
English

Table of Contents Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
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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
1.4 General conventions and structure of the document ................................... 7
1.4.1 Structure of the document.............................................................. 7
1.4.1.1 Identification of the danger levels................................. 7
1.4.1.2 Formats and symbols used .......................................... 7
1.4.2 Operating conventions................................................................... 8
1.4.3 Notes to the repository................................................................... 9
1.5 Warranty and liability.................................................................................... 9
1.6 Intended use ................................................................................................ 10
1.7 Legend ......................................................................................................... 11
2Safety instructions .................................................................................................. 13
2.1 Disturbance of data transmission................................................................. 13
2.2 Basic safety information............................................................................... 13
2.2.1 Prerequisites.................................................................................. 13
2.2.2 Connecting the unit........................................................................ 13
2.2.3 General safety information............................................................. 14
2.2.4 Movement and stability of the unit ................................................. 16
2.2.5 Maintenance and repair ................................................................. 17
2.2.6 Modifications to the product........................................................... 17
2.2.7 Accessories.................................................................................... 17
2.3 Safety labels ................................................................................................ 17
2.4 Electrostatic charge ..................................................................................... 19
2.4.1 ESD warning labels........................................................................ 19
2.4.2 ESD protective measures .............................................................. 19
2.4.3 About the physics of electrostatic charges..................................... 19
2.5 Wireless phone interference with equipment ............................................... 20
2.6 Integration in a network or connection to a modem ..................................... 21
2.7 Disposal ....................................................................................................... 22
3Product description ................................................................................................. 23
3.1 Technical description ................................................................................... 23
3.2 Technical data.............................................................................................. 25

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Table of Contents
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3.3 Controls and functional elements................................................................. 27
3.3.1 Overview of the front panel............................................................ 27
3.3.2 Overview of the rear panel............................................................. 29
3.4 Operating state LED .................................................................................... 30
3.5 Certification .................................................................................................. 31
3.6 Electromagnetic compatibility ...................................................................... 32
3.6.1 Electromagnetic emission.............................................................. 32
3.6.2 Interference immunity .................................................................... 33
3.6.3 Working clearances ....................................................................... 36
4Installation and startup............................................................................................ 37
4.1 Transport and unpacking ............................................................................. 37
4.2 Disposal of packaging materials .................................................................. 37
4.3 Scope of supply ........................................................................................... 37
4.4 Initial startup................................................................................................. 38
4.4.1 Plug connections............................................................................ 38
4.4.2 Using a trackball (if provided, depending on the configuration)..... 39
4.4.3 Insert battery (optional).................................................................. 40
4.4.4 Switching the units on.................................................................... 42
4.4.5 Switching the units off.................................................................... 43
4.4.6 Battery-backed operation (optional)............................................... 44
5Operation ................................................................................................................ 47
5.1 Working with the touch monitor.................................................................... 47
5.1.1 Adjusting the position of the monitor.............................................. 47
5.1.2 Touch functionality......................................................................... 48
5.1.3 Adjusting touch-sensitivity and buzzer volume .............................. 49
5.2 Optical impressions with the scanner .......................................................... 50
5.3 Scanner guide.............................................................................................. 53
5.3.1 Occlusal scan................................................................................. 54
5.3.2 Buccal scan.................................................................................... 54
5.3.3 Lingual scan................................................................................... 55
5.3.4 Approximal surface scan................................................................ 55
5.3.5 Single and multiple buccal registration .......................................... 56
5.3.6 Square and full jaw scan................................................................ 57
5.3.7 Concluding the optical impressions ............................................... 58
5.4 Software for the scanner.............................................................................. 59
5.4.1 Cut out model areas....................................................................... 59

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6Maintenance ........................................................................................................... 60
6.1 Cleaning, disinfection, and sterilization........................................................ 61
6.1.1 Cleaning agents and disinfectants................................................. 61
6.1.1.1 Cleaning agents............................................................ 61
6.1.1.2 Wipe disinfectants (virucidal limited) ............................ 61
6.1.1.3 High-level disinfectant .................................................. 61
6.1.2 Uncritical surfaces including monitor ............................................. 62
6.1.3 Trackball holder (if available)......................................................... 63
6.1.4 Scanner.......................................................................................... 63
6.1.4.1 General information...................................................... 64
6.1.4.2 Components of the scanner ......................................... 65
6.1.4.3 Removing the sleeve.................................................... 66
6.1.4.4 Attaching the sleeve ..................................................... 66
6.1.4.5 Preliminary cleaning of the sleeve................................ 66
6.1.4.6 Wipe disinfection of the scanner and window sleeve ... 67
6.1.4.7 High-level disinfection of the window sleeve ................ 68
6.1.4.8 Hot air sterilization of the window sleeve...................... 73
6.1.4.9 Using disposable sleeves............................................. 74
6.1.5 Cleaning the inside of the sleeve window...................................... 75
6.2 Calibrating the scanner ................................................................................ 76
6.3 Color calibration ........................................................................................... 79
6.4 Replacing the main fuse .............................................................................. 82
6.5 Charge battery (optional) ............................................................................. 83
6.6 Replace battery (optional)............................................................................ 84
6.7 Replacing the O-ring .................................................................................... 85
7Disposal .................................................................................................................. 87
7.1 Disposal of the storage battery pack............................................................ 88
8Appendix................................................................................................................. 89
8.1 Making backup copies ................................................................................. 89
8.2 Seal on PC slide-in module.......................................................................... 89
8.3 Windows Update.......................................................................................... 89
Index ....................................................................................................................... 90

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
1 General data
1.1 Dear Customer,
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1General data
1.1 Dear Customer,
Thank you for your purchase of this CEREC Primescan AC / Primescan
AC® unit from Dentsply Sirona.
The CEREC Primescan AC enables you to produce dental restorations,
e.g. from ceramic material with a natural appearance (CEramic
REConstruction).
The CEREC Primescan AC / Primescan AC allows you to send digital
acquisitions 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
Customer Service Center In the event of technical queries, please use our online contact form at
the following address:
http://srvcontact.sirona.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 CEREC Primescan AC, Primescan AC
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1.3 General information about these operating
instructions
Observe the Operating Instructions Please familiarize yourself with the unit by reading through these
Operating Instructions before putting it into operation. It is essential that
you comply with the specified warning and safety information.
The Operating Instructions are stored on the unit and online at
www.dentsplysirona.com/manuals.
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.
Online portal for technical documents We have set up an online portal for the Technical Documents at
www.dentsplysirona.com/manuals. From here, you can download these
Operating Instructions along with other documents. Please complete the
online form if you would like a hard copy of a particular document. We
will then 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.

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
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 the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in these instructions for use.
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 slight 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 for simplifying work.
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
Requests you to do something.
See "Formats and symbols used
[→7]"
Identifies a reference to another
text passage and specifies its
page number.
● List Designates a list.
"Command / menu item" Indicates commands / menu
items or quotations.

1 General data
1.4 General conventions and structure of the document
Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
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1.4.2 Operating conventions
Example Meaning
Tapping Pressing once and releasing the finger or the left
trackball/touchpad key on the acquisition unit.
Double-tapping Pressing twice quickly in succession and releas-
ing the finger or the left trackball/touchpad key on
the acquisition unit.
Moving the
mouse in one di-
rection
On the acquisition unit: Moving the trackball/fin-
ger in the corresponding direction.
Seizing a point Pressing and holding the left mouse button (left
trackball/touchpad button on the acquisition unit).
"Ctrl+N" On the keyboard: Press the Ctrl and N keys si-
multaneously.
Drag & drop .
Select an element (e.g. a pictograph) and drop /
release it onto a potential destination.
Multi-touch technology (only for systems with touch monitor)
The screen is equipped with multi-touch technology. You can navigate
and enter content using your finger. Icons open if you tap them with
your finger.
Navigating in the software
Example Meaning
Tap Single tap on the screen using your finger.
To execute functions in the software you must tap
once on the corresponding button.
Double-tapping Two taps on the screen in rapid succession using
your finger.
Tip:To open programs in Windows you must tap
the corresponding button twice (double-click).
Call up shortcut
menus
Tap the corresponding point and hold the finger
on the screen for a longer period. A shortcut
menu opens at this point.
Drag & drop .
Tap an element (e.g. pictograph), drag and drop
onto new potential destination.

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
1 General data
1.5 Warranty and liability
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Edit a 3D model with multi-touch
You can edit the 3D model using multi-touch.
Item Function
A➢ Complete a rotary movement using 2 fingers.
ÄThe object is rotated in the plane.
B➢ Drag with 1 finger.
ÄThe model is rotated out of its current plane.
C➢ Pull 2 fingers in together.
ÄThe object is minimized.
D➢ Pull the fingers apart.
ÄThe object is maximized.
E➢ Drag with 2 fingers.
ÄThe model is dragged.
1.4.3 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
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.

1 General data
1.6 Intended use
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1.6 Intended use
The CEREC Primescan AC / Primescan AC acquisition unit creates
digital impressions, which are sent to a laboratory and/or in connection
with the milling unit are used to manufacture computer-supported dental
restorations, e.g. from a natural-appearing ceramic material. 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.
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.
For the USA only
CAUTION: According to US Federal Law, this product may be sold only
to or by instruction of physicians, dentists, or licensed professionals.

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
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 [→17]).
Product disposal symbol (see "Disposal [→87]").
Storage battery pack recycling symbol (see "Disposal of the storage
battery pack [→88]")
The CEREC Primescan AC / Primescan AC acquisition unit may con-
tain an RF transmitter in the form of a WLAN card or a separate wire-
less module.
Radio approval for Australia/New Zealand
Follow the operating instructions.
To ensure safe operation of the unit, the user must follow the operat-
ing instructions.

1 General data
1.7 Legend
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Symbols on the packaging
Take note of the following symbols on the packaging:
Top
Protect from moisture
Fragile; handle with care
Temperature during storage and transport
Relative humidity during storage and transport
Air pressure during storage and transport

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
2 Safety instructions
2.1 Disturbance of data transmission
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2Safety instructions
2.1 Disturbance of data transmission
Note on wireless communication Data communication between the acquisition unit and the CEREC MC
XL production unit should preferably be established via the wireless
interface CEREC Radio Device or WLAN.
As for all wireless connections (e.g. cell phones), heavy utilization of the
available radio channels or shielding caused by building installations
(e.g. metal-shielded X-ray enclosures) may impair the quality of the
connection. This may become noticeable through a reduction in range
and/or a slower data transmission rate. In extreme cases, it will be
impossible to establish a wireless connection at all.
Dentsply Sirona has selected the best possible configuration for data
communication via the wireless interface (CEREC Radio Device) or
WLAN, which generally ensures perfect functioning of this connection.
However, in individual cases unrestricted wireless data communication
may be impossible for the reasons mentioned above and/or due to local
circumstances. In such cases, a cable LAN connection should be
selected to ensure uninterrupted operation. If the only LAN interface on
the rear of the acquisition unit is occupied by another plug, remove this
wireless interface connection and instead connect the LAN cable with
the CEREC MC XL production unit.
2.2 Basic safety information
2.2.1 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!
2.2.2 Connecting the unit
Perform connection by following the directions given in the present
operating instructions.

2 Safety instructions
2.2 Basic safety information
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2.2.3 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
Risk of toxic liquid escaping from a damaged display
There is a risk of injury if toxic liquid escapes from a damaged
display.
➢ Do not touch the LED screen with sharp or pointed objects.
➢ If the LED monitor is damaged (e.g. the glass screen is broken),
prevent any leaking liquid from coming into contact with your skin,
mucous membranes (eyes, mouth), or foodstuffs and be careful
not to inhale any escaping vapors.
➢ Rinse any parts of your body or items of clothing already
contaminated by the liquid with ample amounts of water and
soap.
CAUTION
Note on the prevention, recognition, and elimination of unintended
electromagnetic effects:
The CEREC Primescan AC / Primescan AC 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.
NOTE
Risk of damaging components
Components may be damaged by covering ventilation openings.
➢ Ensure that the ventilation openings are not covered.
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.

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
2 Safety instructions
2.2 Basic safety information
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NOTE
Danger posed by broken glass
Stress to the glass surfaces of the control console and monitor from
strong forces and impacts must be prevented, otherwise there is a
risk of the glass breaking. Prevent impacts to the monitor, especially
around the edges of the cover glass.
CAUTION
Restoration to be checked by trained personnel
Each restoration created must be checked for suitability by a trained
person (e.g. dentist).

2 Safety instructions
2.2 Basic safety information
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2.2.4 Movement and stability of the unit
NOTE
The unit can overturn or slip away
For reasons of tilt stability, the unit must be pulled by its front or rear
handle when being moved. If you push the unit, obstacles on the floor
could block its wheels, thus causing it to overturn.
For transporting the unit (for example to another room), the monitor
must be in a rotated position in order to prevent damage through
impacts. The monitor may be in the upper or swiveled out position.
Make sure that the unit is transported in a stable manner.
All wheels of the unit have brakes which can be locked to ensure
secure positioning. If the unit is steeply inclined or standing on a
slippery surface and lateral forces are acting on it, it may slide even
though the wheel brakes are locked. Horizontal forces in the upper
part of the unit (e.g. on the monitor) can cause the unit to tip over
when the wheels are stationary.
➢ Always make sure that the unit's footprint is a flat, nonskid
surface.
NOTE
Tripping hazard posed by cable connection to USB ports on the
monitor
Tripping hazards that compromise tipping stability may arise due to
the connection of USB cables to the USB ports on the monitor.
➢ Do not connect USB cables to the USB ports on the monitor.
➢ Always connect USB cables to the sockets on the rear of the PC.

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Operating Instructions CEREC Primescan AC, Primescan AC
2 Safety instructions
2.3 Safety labels
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2.2.5 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.
2.2.6 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!
2.2.7 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.
2.3 Safety labels
Fuses
NOTE
Use ONLY fuses of the same type!

2 Safety instructions
2.3 Safety labels
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Plug connections of external interfaces
CAUTION
Adaptation of acquisition unit to external components
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 1.5m
surrounding the patient).
WARNING
Risk of electric shock
Low voltages are applied to the sockets for connecting external
interfaces. In order to maintain electrical safety, the rear covers of the
acquisition unit must be kept closed while it is in operation (service
cover and cover on the monitor).
➢ Do not touch the pins of the connectors.
➢ When using the unit on the patient, please note that the covers on
the rear side of the unit (service cover and cover on the monitor)
must remain closed and voltage sources must not be accessible.
The cover on the monitor must not be opened, if both USB
sockets are in use or locked.
➢ The acquisition unit must not be operated inside of the patient
area (within a radius of 1.5 m surrounding the patient) with the
covers open.
NOTE
Risk of damage to the plugs/cables!
The externally connected plugs/cables may be damaged, if they are
overtensioned or if the plug connections do not snap in.
➢ Do not pull on the cables.
➢ Make sure that the plug connections snap in.

Dentsply Sirona
Operating Instructions CEREC Primescan AC, Primescan AC
2 Safety instructions
2.4 Electrostatic charge
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2.4 Electrostatic charge
2.4.1 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.
2.4.2 ESD protective measures
ESD ESD stands for ElectroStatic Discharge.
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" [→19].
2.4.3 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).

2 Safety instructions
2.5 Wireless phone interference with equipment
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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 3,000 V or higher
● audible at 5,000 V or higher (cracking, crackling)
● visible at 10,000 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.
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.
To prevent this from happening, the ESD warning label next to the plug
warns of this hazard. ESD stands for ElectroStatic Discharge.
Connector pins or sockets bearing ESD warning labels must not be
touched or interconnected without ESD protective measures.
2.5 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.