Sirona Facescan User manual

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Sirona Dental Systems GmbH Table of contents
Installation Instructions Facescan
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Table of contents
1General data............................................................................................................ 6
1.1 Intended use................................................................................................. 6
1.2 System requirements ................................................................................... 6
2About these Installation Instructions........................................................................ 7
2.1 Structure of the document ............................................................................ 7
2.1.1 Identification of the danger levels.................................................... 7
2.1.2 Formats and symbols used ............................................................. 8
2.2 Scope ........................................................................................................... 8
2.3 Prerequisites ................................................................................................ 8
2.4 Recommendation ......................................................................................... 8
2.5 Other documentation required...................................................................... 9
3Safety instructions ................................................................................................... 10
3.1 Modifications to the unit................................................................................ 10
3.2 Fixed connection .......................................................................................... 10
3.3 Electromagnetic compatibility....................................................................... 10
3.4 Electrostatic discharge ................................................................................. 10
3.5 Switching the unit on .................................................................................... 10
3.6 Condensation ............................................................................................... 11
3.7 Ventilation slots ............................................................................................ 11
3.8 Qualifications of service personnel............................................................... 11
3.9 Radiation protection ..................................................................................... 11
3.10 Safety checks ............................................................................................... 11
3.11 Installation by qualified personnel ................................................................ 12
3.12 Potentially lethal shock hazard..................................................................... 12
4Configuration ........................................................................................................... 13
4.1 System overview .......................................................................................... 13
4.2 Status displays ............................................................................................. 15
5Delivery.................................................................................................................... 16
6Installation ............................................................................................................... 18
6.1 Preparation................................................................................................... 18
6.2 Removing cover parts .................................................................................. 19
6.3 Conversion of non-"Facescan ready devices".............................................. 19

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Table of contents Sirona Dental Systems GmbH
Installation Instructions Facescan
6.4 Installing PoE module ................................................................................... 20
6.5 Converting the covers of the X-ray detector.................................................. 23
6.6 Attaching cover parts .................................................................................... 25
6.7 Attaching the scan unit.................................................................................. 25
6.7.1 Screwing in the scan unit ................................................................. 25
6.7.2 Connecting scan unit electrically...................................................... 28
6.7.2.1 Step 1: Connect................................................................. 28
6.7.2.2 Step 2: Further steps......................................................... 30
6.7.3 Attaching the Facescan cover.......................................................... 31
6.7.3.1 Step 1: Preparation and cleaning...................................... 31
6.7.3.2 Step 2: Installation............................................................. 31
6.7.3.3 Step 3: Further steps......................................................... 32
7Commissioning......................................................................................................... 34
7.1 Configuring GALILEOS ................................................................................. 34
7.2 Connection to the network ............................................................................ 34
7.2.1 Configuration.................................................................................... 34
7.2.1.1 Explanation........................................................................ 34
7.2.1.2 Configuration options ........................................................ 34
7.2.1.3 Type 1: Configuration using the Facescan USB stick .......35
7.2.1.4 Type 2: Configuration over a network cable (peer-to-peer)37
7.2.2 Connecting with a network ............................................................... 38
7.3 Connecting to SIDEXIS................................................................................. 38
7.4 Calibration ..................................................................................................... 39
7.4.1 Steps to take in case of errors ......................................................... 41
7.5 White balance ............................................................................................... 41
7.6 Test exposure ............................................................................................... 42
7.6.1 Example 1 ........................................................................................ 43
7.6.2 Example 2 ........................................................................................ 44
7.6.3 Example 3 ........................................................................................ 45
8Final work ................................................................................................................. 46
8.1 Filling in the installation report and warranty passport .................................. 46
8.2 Filling in the certificate of conformity ............................................................. 48
8.3 Unit handover................................................................................................ 49
9Appendix .................................................................................................................. 50
9.1 Checking the protective ground wires ........................................................... 50
9.2 Conversion instructions for non-"Facescan ready" units............................... 53
9.2.1 Removing cover parts ...................................................................... 53
9.2.2 Removing board DX32..................................................................... 54

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Sirona Dental Systems GmbH Table of contents
Installation Instructions Facescan
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9.2.3 Removing energy chain 1 (right) ..................................................... 55
9.2.4 Installing new energy chain 1 .......................................................... 58
9.2.5 Routing new cables in the stand ..................................................... 59
9.2.6 Attaching board DX32 ..................................................................... 61
9.2.7 Connecting switch S1...................................................................... 61
9.2.8 Removing the laser module............................................................. 63
9.2.9 Removing the cable conduit with cable L13 on the ring .................. 63
9.2.10 Lay cable conduit L78 on the ring ................................................... 64
9.2.11 Connecting cable L78(L73) to the X-ray detector............................ 66
9.2.12 Checking the protective ground wire (measuring point H) .............. 66
9.2.13 Attaching cover parts....................................................................... 67
9.2.14 Adjusting the laser module .............................................................. 68
9.2.15 Completion ...................................................................................... 68

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1General data Sirona Dental Systems GmbH
1.1Intended use Installation Instructions Facescan
1General data
1.1 Intended use
The Facescan extension is intended for use as follows:
● The Facescan extension equips the GALILEOS with a 3D surface
scanner so that you can capture the surface of the patient's face in
color, either in addition to 3D X-ray volume imaging or without using
this technique at all (and, therefore, without any exposure to
radiation). The 3D surface scanner is used to generate a surface
model of the patient's head.
Application:
Patient marketing/communication:
The surface model that is generated can be used to explain medical
issues and possible treatment options to the patient.
The Instructions for Use and the Inspection and Maintenance Instructions
of the GALILEOS and the Facescan must be followed.
1.2 System requirements
SIDEXIS and GALILEOS version
● GALILEOS firmware from complete unit software V04.12
● SIDEXIS XG from version 2.5.6
● SIDEXIS 4 in version 4.1.1 and higher
● GALILEOS software from version 2.00
Hardware requirements
Note the GALILEOS and SIDEXIS installation requirements.
CAUTION
Potential errors in medical treatment
The Facescan extension must not be used for diagnosis, treatment or
planning medical treatment.
CAUTION
Undesirable radiation
Combining an X-ray exposure with a Facescan exposure is not
permitted unless there is a justifying indication for this. This is because
of the exposure to radiation that accompanies this procedure.
If an X-ray exposure is being used in combination with a Facescan
exposure, but the surface exposure process fails, the patient must not
be X-rayed again.

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Sirona Dental Systems GmbH 2About these Installation Instructions
Installation Instructions Facescan 2.1Structure of the document
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2About these Installation Instructions
2.1 Structure of the document
2.1.1 Identification of the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in the present operating
instructions. Such information is highlighted as follows:
Tip: Information on making work easier.
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.
NOTICE
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.

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2About these Installation Instructions Sirona Dental Systems GmbH
2.2Scope Installation Instructions Facescan
2.1.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
2.2 Scope
Scope of installation instructions: FaceScan
These installation instructions descibe the installation of the 3D surface
scanner Facescan. They are intended for use exclusively by trained and
authorized distributors and service technicians.
2.3 Prerequisites
The following requirements must be met to equip a GALILEOS with
Facescan:
● The network cable of the network connector being used must allow
two IP addresses (GALILEOS+Facescan).
●Also, at the same time, the IP addresses of the following network
components must be accessible through the work station:
- GALILEOS
- Facescan
- Sirona-Reconstruction-Server (RCU)
2.4 Recommendation
For best results, GALILEOS should have a head fixation device.
If there is no head fixation device, GALILEOS can be fitted with a head
fixation device at a later time.
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 [ → 8]"
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.

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Sirona Dental Systems GmbH 2About these Installation Instructions
Installation Instructions Facescan 2.5Other documentation required
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2.5 Other documentation required
In addition to these installation instructions you will require the following
documentation:
User documentation
● Facescan Operator´s Manual
Order No. 6376334
Installation Instructions
● GALILEOS Installations Instructions:
Order no. 6125574 (Worldwide) / 6125608 (U.S.)
● GALILEOS / ORTHOPHOS XG 3D Software Installation:
Order no. 61 42 389
●For the SIDEXIS XG only: SIDEXIS XG Digital Radiography
Installation Instructions:
Order No. 59 67 356
●SIDEXIS 4: SIDEXIS 4 Installation Instructions:
Order No. 64 47 200
GALILEOS wiring diagrams
Wiring diagrams
● GALILEOS Wiring References: REF 61 25 640
Service Manual: GALILEOS/Facescan
Service Manual
● GALILEOS Service Manual: REF 61 25 665

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3Safety instructions Sirona Dental Systems GmbH
3.1Modifications to the unit Installation Instructions Facescan
3Safety instructions
3.1 Modifications to the unit
Modifications to this unit which might affect the safety of the system
owner, patients or other persons are prohibited by law!
For reasons of product safety, this product may be operated only with
original Sirona accessories or third-party accessories expressly approved
by Sirona. The user is responsible for any damage resulting from the use
of non-approved accessories.
3.2 Fixed connection
3.3 Electromagnetic compatibility
The unit complies with the requirements of standard IEC 60601-1-2.
Medical electrical equipment is subject to special EMC preventive
measures. It must be installed and operated as specified in the document
"Installation Requirements".
If high-voltage systems, radio link systems or MRI systems are located
within 5 m of the unit, please observe the specifications stated in the
installation requirements.
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless
phones in medical office or hospital environments must be prohibited.
Reference to ESD protective measures in operating instructions
Please also observe the ESD protective measures in the chapter entitled
"Electrostatic discharge".
3.4 Electrostatic discharge
Electrostatic discharge (abbreviated: ESD – ElectroStatic Discharge)
Electrostatic discharge from people can damage electronic components
when the components are touched.
Touch a ground point to discharge static electricity before touching any
boards.
3.5 Switching the unit on
Safety information for switching on the unit: Service engineer
Due to the risk of injury caused by malfunction, no person may be
positioned in the unit when it is switched on.
DANGER
Potentially lethal shock hazard!
Fixed connection!
Installing a mains plug instead of the specified fixed connection infringes
international medical regulatory actions and is prohibited. In case of
error, this puts patients, users, and other parties seriously at risk.

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Sirona Dental Systems GmbH 3Safety instructions
Installation Instructions Facescan 3.6Condensation
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3.6 Condensation
Safety inf ormation for conden sation: Customer
Extreme fluctuations of temperature may cause condensation inside the
unit. Do not switch the unit on before it has reached normal room
temperature. See the chapter on “Technical data”.
Safety inf ormation for conden sation: Service engineer
Extreme fluctuations of temperature may cause condensation inside the
unit. Do not switch the unit on before it has reached normal room
temperature. See also Technical Data.
3.7 Ventilation slots
Ventilation slots
Never cover the ventilation slots on the unit under any circumstances,
since this may obstruct air circulation. This can cause the unit to overheat.
3.8 Qualifications of service personnel
Installation and startup may be carried out only by personnel specifically
authorized by Sirona.
3.9 Radiation protection
Safety information for radiation protection: Service engineer
The valid radiation protection regulations and measures must be
observed. The statutory radiation protection equipment must be used.
During an exposure, the service engineer should move as far away from
the X-ray tube assembly as the coiled cable of the manual release
permits.
With the exception of the service engineer, no other persons are allowed
to stay in the room during an exposure.
In case of malfunctions, cancel the exposure immediately by letting go of
the exposure release button.
Information about radiation protection for Canada
3.10 Safety checks
Safety checks
Once repair is completed, circuit breaker test and unit leakage current
test must be carried out (see chapter Checking circuit breaker and
Checking the device leakage current).
NOTICE
3D imaging should not be used for screening examinations. 3D imaging
examinations must be clinically warranted and each exam must be
justified by demonstrating that the benefits outweigh the risks.
NOTICE
Where it is likely that evaluation of soft tissues will be required as part of
the patient's radiological assessment, the appropriate imaging should
be conventional medical CT or MR, rather than 3D imaging using Cone
Beam technology.

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3Safety instructions Sirona Dental Systems GmbH
3.11Installation by qualified personnel Installation Instructions Facescan
3.11 Installation by qualified personnel
Installation according to the requirements of SIRONA
3.12 Potentially lethal shock hazard
CABA-No. 7000000086
Potentially lethal shock hazard
* = if available (PoE module for the power supply of a FACESCAN unit.)
CAUTION
Risk of injury!
The installation must be carried out in accordance with the requirements
stated in our Installation Instructions.
Installation may be carried out only by personnel specifically authorized
by Sirona.
DANGER
Perilous shock hazard!
When replacing parts or in the event of extensions in the power supply
line, power switch, board DX32, X-ray or PoE module* area, there is
danger to life due to a potentially lethal shock hazard.
Before you begin:
➢It is essential to ensure the unit is not supplied with voltage.
➢Always disconnect the unit from the junction box of the building
installation.

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Sirona Dental Systems GmbH 4Configuration
Installation Instructions Facescan 4.1System overview
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4Configuration
4.1 System overview
Complete unit overview
AGALILEOS unit
BFacescan

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4Configuration Sirona Dental Systems GmbH
4.1System overview Installation Instructions Facescan
Overview of Facescan
CStatus display (see section Status displays [ → 15])
DIlluminated strips (hidden in the image)
ECameras

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Sirona Dental Systems GmbH 4Configuration
Installation Instructions Facescan 4.2Status displays
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4.2 Status displays
Explanation
The unit displays the relevant operating conditions via two LEDs.
Operating conditions
FACESCAN operating conditions
LED Blue (A) LED Green (B) Meaning
Off Off ● FaceScan components are
switched off
● FaceScan components have
shut themselves down.
● A firmware update using the
FaceScan USB stick has been
completed
Off On ● Standby
Flashing Off ● Exposure readiness
● Device ready for data transfer
On Off ● Acquisition (release button
pressed)
On Flashing ● Acquisition (release button
pressed and data transfer)
Off Flashing ● Data transfer
On On ● Boot process
● White balance
● Network configuration
● Firmware update
● Reset to factory settings
Alternating with
green LED at
one-second
intervals.
Alternating with
blue LED at one-
second
intervals.
● Data upload during web
update

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5Delivery Sirona Dental Systems GmbH
Installation Instructions Facescan
5Delivery
Title Scope of delivery
Scope of supply
FaceScan scope of delivery
● Cardboard box with basic unit
– Chassis with transport lock
– USB stick (attached to the chassis in a bag)
– PoE module
– Positioning aid
– Installation material
– Cable L71
● Cardboard box with cover set
– Housing cover
– Image intensifier cover, complete
– Cover casing, right + left
● Technical Documents
– Installation Report/Warranty Passport
– Declaration of conformity
– Documentation DVD
●Only in the event of a separate order:
Additional parts for GALILEOS units earlier than serial number 9000
(Not FaceScan Ready units).
– Geometry phantom
– Cable L78
– Cable L77
Damage following delivery
Indicators
Indicators: FaceScan
Shock indicators have been put on the packaging of the device, which
can help you notice whether the device was subjected to any knocks
during transportation.
● White indicator: No shock
● Red indicator: Shock
The display of improper transport doesn't necessarily mean that the unit
is damaged.
Make a note on the delivery slip that the indicator is activated. Ensure that
the driver from the transport company confirms this on the delivery slip.
Fax the delivery slip to the Sirona Customer Service Center (CSC).
NOTICE
Possible transport damage
If the shipment was damaged during transport, document all damage
carefully and contact the responsible carrying agent immediately.

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Sirona Dental Systems GmbH 5Delivery
Installation Instructions Facescan
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Enter the state of the indicators in the startup report in the case of
warranty claims.
Disposal of packaging materials
Disposal of packaging materials
Return the packaging materials to Sirona or dispose of them in
compliance with the legal regulations applicable in your country.

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6Installation Sirona Dental Systems GmbH
6.1Preparation Installation Instructions Facescan
6Installation
6.1 Preparation
The first work steps
The first work steps
1. Move the arm (B) up to 1260 (over the spacer (A)).
2. Disconnect GALILEOS from the network.

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Sirona Dental Systems GmbH 6Installation
Installation Instructions Facescan 6.2Removing cover parts
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6.2 Removing cover parts
➢Remove the following cover parts (pay attention to the order!):
1. Spacer (B)
2. Lower cover profile (A)
6.3 Conversion of non-"Facescan ready devices"
Scope
GALILEOS Comfort unit up to series number 8999.
Conversion
See the section titled "Conversion instructions for non-"Facescan ready"
units [ → 53]“.
IMPORTANT
Only remove the cover parts mentioned in the text!

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6Installation Sirona Dental Systems GmbH
6.4Installing PoE module Installation Instructions Facescan
6.4 Installing PoE module
Preparation
CABA-No. 7000000086
1. DANGER! Potentially lethal shock hazard! Disconnect the
GALILEOS from the junction box of the building installation.
2. Only applicable for units prepared in the factory: Cut through the
cable tie (A) on the Ethernet cable L77(L72).
Securing
1. Insert two plastic clamping terminals into the shaft (S).
2. Tip: Prevent the plastic clamping terminals from slipping using
adhesive tape.
3. Put a serrated washer on the thread bolts (H).
4. Put the PoE module (P) on the thread bolts (H) of the mains filter plate
(J) (the serrated washer must sit behind the fitting plate of the PoE
module).
5. Screw down the PoE module (P) to the place provided in the stand
with two screws (K) and a nut (L).
IMPORTANT
Possible assembly errors
➢Make sure that cable L76 is behind the mains filter plate (J).