Sirona inEos X5 Operating Instructions Manual

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inEos X5 - Operating Ins tructions
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Table of contents Sirona Dental Systems GmbH
Operating Instructions inEos X5
Table of contents
1
Dear Customer, ........................................................................................................ 5
2
General data............................................................................................................. 6
2.1 Structure of the document............................................................................. 6
2.1.1 Identification of the danger levels..................................................... 6
2.1.2 Formats and symbols used .............................................................. 7
2.2 Legend .......................................................................................................... 7
3
Safety ....................................................................................................................... 9
3.1 Basic safety information ................................................................................ 9
3.1.1 Prerequisites .................................................................................... 9
3.1.2 Connecting the unit .......................................................................... 9
3.1.3 Connection of external equipment ................................................... 9
3.1.4 Maintenance and repair ................................................................... 10
3.1.5 Modifications to the product ............................................................. 10
3.1.6 Accessories...................................................................................... 10
3.1.7 In case of damage............................................................................ 10
3.2 Blue light radiation (UV) ................................................................................ 11
3.3 To be taken into account during automatic operation ................................... 11
3.4 Intended use ................................................................................................. 12
3.5 Certification ................................................................................................... 12
4
Technical description................................................................................................ 13
4.1 Design and function ...................................................................................... 13
4.2 System components...................................................................................... 13
4.2.1 Components of the inEos X5 ........................................................... 13
4.3 Technical data............................................................................................... 15
4.4 System requirements .................................................................................... 16
4.5 Electromagnetic compatibility........................................................................ 16
4.5.1 Electromagnetic emission ................................................................ 16
4.5.2 Interference immunity....................................................................... 17
4.5.3 Working clearances.......................................................................... 19
5
Transport to the installation site ............................................................................... 20
5.1 Transport and unpacking .............................................................................. 20
5.2 Installation site .............................................................................................. 21
6
Initial startup............................................................................................................. 22
6.1 Putting the inLab 4 PC into operation ........................................................... 22
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Sirona Dental Systems GmbH Table of contents
Operating Instructions inEos X5
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6.1.1 Startup prerequisites ....................................................................... 22
6.1.1.1 Required accessories....................................................... 22
6.1.1.2 Making connections.......................................................... 24
6.1.2 Safety .............................................................................................. 25
6.1.3 Possible sources of error................................................................. 25
6.2 Installing the software................................................................................... 26
6.3 Connecting the unit ...................................................................................... 27
6.3.1 Connecting the unit to the PC ......................................................... 27
6.3.2 Connecting the unit to the power supply ......................................... 27
6.3.3 Connecting the foot switch (optional) .............................................. 27
6.3.4 Switching the unit on and starting the software............................... 28
6.4 Calibrating the motor arm............................................................................. 28
6.5 Calibrating the inEos X5 camera.................................................................. 29
6.6 Updating the firmware .................................................................................. 30
7
Controls and displays .............................................................................................. 31
7.1 Controls on the inEos X5.............................................................................. 31
7.2 Operating state LED..................................................................................... 32
8
Switching the system on.......................................................................................... 33
9
Performing 3D acquisition ....................................................................................... 34
9.1 General......................................................................................................... 34
9.1.1 Acquisition methods ........................................................................ 34
9.1.2 Scan modes .................................................................................... 35
9.1.3 Scan options.................................................................................... 36
9.1.4 Model options .................................................................................. 37
9.1.5 Scan models and impressions ........................................................ 38
9.1.6 Autofocus ........................................................................................ 38
9.1.7 Deleting images............................................................................... 38
9.1.8 Operation via foot switch................................................................. 38
9.2 Starting the unit/standby mode..................................................................... 39
9.3 Automatic jaw scan ...................................................................................... 40
9.3.1 Preparing the optical impression ..................................................... 40
9.3.2 Taking the scan ............................................................................... 41
9.3.3 Guideline editor ............................................................................... 42
9.3.4 Starting the automatic detail scan ................................................... 42
9.4 Free scans.................................................................................................... 42
9.4.1 Preparing the optical impression ..................................................... 43
9.4.2 Automatic and manual release in the "free scan" mode.................. 43
9.4.3 Taking a free scan (without previous automatic scans) .................. 44
9.4.4 Taking a free detail scan ................................................................. 44
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Table of contents Sirona Dental Systems GmbH
Operating Instructions inEos X5
9.5 Rotational scans............................................................................................ 45
9.5.1 Preparing the optical impression...................................................... 46
9.5.2 Taking a rotational scan ................................................................... 46
9.6 Acquiring a buccal registration ...................................................................... 47
9.7 Scanbody scans for scanning with inPost and ATLANTIS-FLO-S scanbodies
48
10
Regular function test of the light barrier and the Start key ....................................... 49
11
Cleaning and care .................................................................................................... 51
11.1 Cleaning the outer surface ............................................................................ 51
11.2 Protection against medicaments ................................................................... 51
11.3 Cleaning the optics........................................................................................ 51
12
Accessories .............................................................................................................. 52
12.1 Using the articulator plate ............................................................................. 53
13
Disposal.................................................................................................................... 54
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Sirona Dental Systems GmbH 1Dear Customer,
Operating Instructions inEos X5
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1
Dear Customer,
Thank you for purchasing your inEos X5® from Sirona.
Improper use and handling can create hazards and cause damage. Please read and follow these operating instructions carefully and Always keep them within easy reach.
To prevent personal injury or material damage, it is important to observe all safety information.
Your inEos X5 team,
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2General data Sirona Dental Systems GmbH
2.1Structure of the document Operating Instructions inEos X5
2
General data
Please read this document completely and follow the instructions exactly. You should always keep it within reach.
Original language of the present document: German.
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 this document. This information is highlighted as follows:
Tip: Information for facilitating work.
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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Sirona Dental Systems GmbH 2General data
Operating Instructions inEos X5 2.2Legend
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2.1.2 Formats and symbols used
The formats and symbols used in this document have the following meaning:
2.2
Legend
Year of manufacture
Safety symbols
Fragment: Warning of optical radiation
"Warning of optical radiation" symbol
Warning of injuries to eyes and skin in the vicinity of optical radiation.
Fragment: Warning of hand i njuries
Description of the packaging
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 Identifies a list.
“Command / menu item” Identifies commands, menu items, or
quotations.
Year of manufacture
"Warning of hand injuries" symbol
Warning of hand injuries in the vicinity of devices with closing mechanical parts.
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2General data Sirona Dental Systems GmbH
2.2Legend Operating Instructions inEos X5
Symbols on the packaging
Take note of the following symbols on the packaging:
Top
Keep dry
Fragile
Stack limit 2
Transport temperature -40 - +70
Transport humidity 10 - 95
Transport air pressure 50 0 - 1060
Top
Protect from moisture
Fragile; handle with care
Do not stack
Temperature during storage and transport
-40
+70
Relative humidity during storage and transport
95
10
Air pressure during storage and transport
1060
500
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Sirona Dental Systems GmbH 3Safety
Operating Instructions inEos X5 3.1Basic safety information
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Safety
3.1
Basic safety information
3.1.1 Prerequisites
Fragment: Main installation ofsign
Fragment everything excluding APOLLO DI
Fragmen
3.1.2 Connecting the unit
Description
Perform connection by following the directions given in the present operating instructions.
3.1.3 Connection of external equipment
If any equipment not approved by Sirona is connected, it must comply with the applicable standards:
● EN 60 950 for information technology equipment, and
● EN 61 010-1 for laboratory equipment.
NOTICE
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.
NOTICE
Important information on building installation
The building installation must be performed by a qualified expert in compliance with the national regulations. DIN VDE 0100-710 applies in Germany.
NOTICE
Important information on building installation
The building installation must be performed by a qualified expert in compliance with the national regulations.
NOTICE
Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion hazards.
NOTICE
Do not damage the unit!
The unit can be damaged if opened improperly.
It is expressly prohibited to open the unit with tools!
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3Safety Sirona Dental Systems GmbH
3.1Basic safety information Operating Instructions inEos X5
3.1.4 Maintenance and repair
Fragment: Manufacturer
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:
Fragment: Distributo r
As distributors 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 Sirona or by agencies authorized by Sirona.
● Components which have failed and influence the safety of the unit must be replaced with original (OEM) spare parts.
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.
3.1.5 Modifications to the product
Modifications to this product which may affect the safety of the operator, patients or third parties are prohibited by law!
3.1.6 Accessories
Product safety with the power cable
In order to ensure product safety, this device may be operated only with original Sirona accessories or third-party accessories expressly approved by Sirona. In particular, only the power cable supplied with the unit 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.
3.1.7 In case of damage
In case of noticeable malfunctions or damage, stop using the instrument immediately and notify your authorized dealer or the manufacturer.
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Sirona Dental Systems GmbH 3Safety
Operating Instructions inEos X5 3.2Blue light radiation (UV)
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3.2
Blue light radiation (UV)
3.3
To be taken into account during automatic operation
A Lamp
WARNING
Potentially hazardous optical radiation
Do not look directly at the lamp during operation, as eye damage can result.
NOTICE
No reflective objects in the working area
Do not bring any reflective objects into the working area of the lamp.
CAUTION
Risk of injury! / collision hazard!
During automatic operation there is a risk of injury/collision hazard as a result of the swiveling movement of the articulated arm.
➢ Ensure that there are no objects and/or body parts on the work plate
(shaded area) during automatic operation.
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3Safety Sirona Dental Systems GmbH
3.4Intended use Operating Instructions inEos X5
3.4
Intended use
Intended use of the inEos X5_XM
This system is used for 3D digitization of single tooth or complete jaw models and impressions.
Follow the operating ins tructions
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.
For the USA only
For the USA only
CAUTION: Federal law (USA) restricts sale of this device to or on the order of a physician, dentist, or licensed practitioner.
3.5
Certification
Machinery directive CE mark
CE mark
This product bears the CE mark in accordance with the provisions of Council Directive 2006/42/EC (machinery directive). As such, the following standards apply: DIN EN ISO 12100:2011-03, DIN EN 61010­1:2011-07 and DIN EN 61326-1:2013-07.
Examples EN60950 + CAN/CSA
Examples of CE mark for connected products:
● EN 60950:1992 + A1:1993 + A2:1993 + A3:1995 + A4:1997 based on IEC 60950
● CAN/CSA-C22.2 No.61010-1-04.
CSA mark
CSA mark
VDE mark
VDE mark
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.
CAUTION
CE mark for connected products
Further products which are connected to this unit must also bear the CE mark. These products must be tested according to the applicable standards.
CUS
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Sirona Dental Systems GmbH 4Technical description
Operating Instructions inEos X5 4.1Design and function
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4
Technical description
4.1
Design and function
The inEos X5 is designed as a desktop unit and consists of several components (see Chapter "System components [ → 13]“). It is powered from the standard local power network via an external power supply unit.
The unit is connected to a PC via a USB port. The PC must fulfill the minimum requirements (see Chapter on "System requirements").
The PC serves both for controlling the inEos X5 and for displaying the captured images by means of the user software.
4.2
System components
"inEos X5"
consists of a base plate, a vertical unit and an articulated arm. In addition, various accessories are included in the scope of supply of the unit.
4.2.1 Components of the inEos X5
Front side
A Vertical unit D Ready LED
B Articulated arm E Start button
C Base plate F Scan element opening,
scan element
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4Technical description Sirona Dental Systems GmbH
4.2System components Operating Instructions inEos X5
Rear side
A Main switch
B Supply voltage input (external power supply unit)
C USB port
M
24 V
USB
2.0
M6324649
Model-No. D3586 Merial-No. 00106 REF 6324649
Sirona Dental Systems GmbH Fabrikstr. 31 D-64625 Bensheim
Made in Germany
2013
S00106
24 V / 120 W
A B
C
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Sirona Dental Systems GmbH 4Technical description
Operating Instructions inEos X5 4.3Technical data
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4.3
Technical data
Model designation inEos X5
Power supply line via power supply unit:
INPUT: 100 - 240 V AC / 47- 63 Hz / 2.0 A max.
permissible line voltage fluctuations: ± 10% of nominal voltage
Overvoltage category II
OUTPUT: 24V / 6.25A max.
Power consumption 150W
Ambient conditions For indoor use
Pollution degree 2
Temperature: 10°C – 35°C (50°F ~ 95°F)
Relative humidity: 30% – 75%
Air pressure: 700hPa – 1060hPa
Operating altitude: ≤ 2,000m
Transport and storage conditions
Temperature: -40°C – +70°C (-40°F ~ 158°F)
Relative humidity: 10% – 95%
Air pressure: 500hPa – 1060hPa
Dimensions (WxHxD) in mm in inches
475 x 740 x 460 mm 18 ¾ x 29 ⅛ x 18 ⅛ in.
Weight
● without power supply unit and accessories
39,6 kg (87.3 lbs)
Protection class Class I device
Degree of protection against ingress of water
Ordinary equipment (not protected)
Operating mode Continuous operation with intermittent loading corresponding to the
laboratory mode of working.
Desktop unit
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4Technical description Sirona Dental Systems GmbH
4.4System requirements Operating Instructions inEos X5
4.4
System requirements
A 64-bit inLab 4 PC is required to run this software. The hardware version must be PC hardware version 2.0.1 or higher.
4.5
Electromagnetic compatibility
Fragment: inEos X5
Observance of the following information is necessary to ensure safe operation regarding EMC aspects.
inEos X5 complies with the requirements for electromagnetic compatibility (EMC) according to DIN EN 61326-1:2006-10.
inEos X5 is hereinafter referred to as "UNIT".
4.5.1 Electromagnetic emission
The UNIT is intended for operation in the electromagnetic environment specified below.
The customer or user of the UNIT should make sure that it is used in such an environment.
Tests/approvals This unit complies with the following requirements:
DIN EN 61 010-1: 2011 (safety) DIN EN 61 326-1: 2006 (EMC) DIN EN ISO 12 100: 2011 (risk management)
Emission measurement Conformity Electromagnetic environment - guidelines
RF emissions according to CISPR 11 Group 1 The UNIT uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions according to CISPR 11 Class B The UNIT is intended for use in all facilities,
including residential areas and in any facilities connected directly to a public power supply providing electricity to buildings used for residential purposes.
Harmonics according to IEC 61000-3-2
Class A
Voltage fluctuations / flicker according to IEC 61000-3-3
coincides
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Sirona Dental Systems GmbH 4Technical description
Operating Instructions inEos X5 4.5Electromagnetic compatibility
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4.5.2 Interference immunity
The UNIT is intended for operation in the electromagnetic environment specified below.
The customer or user of the UNIT should make sure that it is used in such an environment.
Interference immunity tests
DIN EN 61326-1 Test level Compliance level Electromagnetic environment –
guidelines
Electrostatic discharge (ESD) according to IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst according to IEC 61000-4-4
± 1 kV for input and output lines
± 2 kV for power supply lines
± 1kV for input and output lines
± 2 kV for power supply lines
The quality of the line power supply should be that of a typical commercial or hospital environment.
Surge voltages according to IEC 61000-4-5
± 1 kV differential mode voltage
± 2 kV common mode voltage
± 1 kV differential mode voltage
± 2 kV common mode voltage
The quality of the line power supply should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and variations of the power supply according to IEC 61000-4-11
<5% U
T
for ½ period
(>95% dip of U
T
)
40% U
T
for 5 periods (60%
dip of U
T
)
70% U
T
for 25 periods
(30% dip of U
T
)
<5% U
T
for 5sec. (>95%
dip of U
T
<5% UT for ½ period (>95% dip of U
T
)
40% U
T
for 5 periods
(60% dip of U
T
)
70% U
T
for 25 periods
(30% dip of U
T
)
<5% U
T
for 5sec. (>95%
dip of U
T
The quality of the line power supply should be that of a typical commercial or hospital environment.
Continued operation of the UNIT is possible following interruptions of the power supply, since the UNIT is powered by an uninterruptible power supply backed up by a storage battery.
Magnetic field of power frequencies (50/60 Hz) according to IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note: U
T
is the AC supply voltage prior to application of the test level.
Portable and mobile radio equipment must not be used within the recommended working clearance from the UNIT and its cables, which is calculated based on the equation suitable for the relevant transmission frequency.
Recommended working clearance:
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