Owandy Radiology i-max touch 3D User manual

EN USER MANUAL
I-MAX 3D
NIMXEN020I June 2022

User Manual - Revision history
NIMXEN020I
Owandy Radiology SAS
Revision history Manual code NIMXEN020I
Rev.
Date
Page/s
Modification description
0
21.12.16
-
Document approval
1
15.11.17
from 21 to 23, 33, 43,
44, from 46 to 53,
64, 66, 69, 70,
from 81 to 83
Added 110-120V version information (MET safety
marking).
Added dimensions for wall mounted with floor
support version.
Updated CDTI information.
Added QC Program description.
Added scanning of dental impression and dental
models feature description.
Exam procedure improvement.
Anatomic exposure parameters updated.
Added Warnings in patient positioning.
(Ref. RDM 8480, RDM 8505, RDM 8644, RDM 8655)
2
14.03.18
2, 4, 17, 27, 29, 31,
35, from 47 to 66,
74, 77, 79, 80, 83,
96, 97
Quality control program improvement.
Cybersecurity information added.
Improvement on patient positioning information
(paediatric patient).
Added FOV for 80x80mm collimator.
Added dimensions for floor mounted version
Minor description improvement.
(Ref. RDM 8651, RDM 8742, RDM 8753)
3
20.11.18
9, 12, 13, 19,
from 24 to 26, 40, 47, 48,
51, 52, from 54 to 61,
63, 64, 69, 70,
from 81 to 83,
from 91 to 93, 102,
103, from 107 to 109
FDA approved revision.
Updated "Warnings" paragraph (added pediatric use
information).
Updated "Cybersecurity measures" paragraph.
Updated "Quality assurance program" chapter.
Added "Metal artefact reduction filter (MAR)" chapter.
Emergency button information added.
Error messages update.
(Ref. RDM 8887, RDM 8888)
4
02.07.19
1, 3, 4, 8,
from 14 to 16,
from 23 to 28, 33, 39,
40, 71, 101, 111
Release of extended volumes functionality.
Compliance to IEC60601-1:AM1.
(Ref. RDM 8923, RDM 8994)
5
09.12.19
26, 28, 101
4
20, from 22 to 24
Correction of extended volumes size
Correction of X-ray beam size for mandibular and
maxillary dentition
Introduction of e-IFU symbol and update of the labels
6
19.05.20
from 72 to 73
Correction of item numbers of chin, bite and TMJ
supports
0G
11.01.21
1, 6, 24, 27, 95, 97, 98
19, 20
22, 23
26, 30
46
97, 98
Alignment of exam names in the document
Update of used symbols at paragraph 3.6
Update of labels at paragraph 5.1
Correction of max line apparent resistance from 0.4
to 0.2 ohm and introduction of line voltage regulation
of <3% @ 99V. Added total filtration ≥ 2,5 mm Al eq.
@ 86 kV ref. IEC 60601-1-3 Par. 7.1 and update of
inherent filtration at chapter 6 (additional filtration
value was removed)
Added new chapter 7 –Removable part list
Added the acquisition mode selection between

User Manual - Revision history
NIMXEN020I
Owandy Radiology SAS
standard definition and high definition for 3D Single
Jaw, 3D Maxillary Teeth and 3D Mandibular Teeth
exams
0H
11.04.22
9
20, 21
24
27,28
Update laser labels
Update system labels
Update exposure times
Update laser and sensor characteristics
0I
20.06.22
86
Adjusted mistake at par. Dental impression/Dental
scan

User Manual - Revision history
NIMXEN020I
Owandy Radiology SAS
THIS PAGE IS INTENTIONALLY LEFT BLANK

User Manual - Contents
NIMXEN020I
Owandy Radiology SAS
Contents
1. INTRODUCTION ....................................................................................... 1
1.1 ICONS APPEARING IN THE MANUAL..............................................................................1
2. SPECIFICATION OF THE INTENDED USE.............................................. 2
2.1 APPLICATION AND MEDICAL PURPOSE........................................................................2
2.1.1 INTENDED PATIENT POPULATION ....................................................................2
2.1.2 OPERATOR PROFILE...........................................................................................2
2.1.3 APPLICATION ENVIRONMENTS ......................................................................... 2
2.2 APPLIED PARTS................................................................................................................3
2.3 TYPICAL DOSES DELIVERED TO THE PATIENT DURING EXTRA-ORAL EXAMS ......3
2.3.1 PANORAMIC MODE..............................................................................................4
2.3.2 3D MODE...............................................................................................................6
3. SAFETY INFORMATION .......................................................................... 7
3.1 WARNINGS.........................................................................................................................8
3.1.1 PRECAUTIONS WHILE USING LASER CENTRING DEVICES...........................9
3.2 PROTECTION AGAINST RADIATION.............................................................................10
3.2.1 PEDIATRIC USE: SUMMARY .............................................................................11
3.2.1.1 INTRODUCTION.....................................................................................11
3.2.1.2 REFERENCES FOR PEDIATRIC DOSE OPTIMIZATION.....................11
3.2.1.3 DEVICE SPECIFIC FEATURES AND INSTRUCTIONS ........................11
3.3 INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY..................................12
3.3.1 ELECTROMAGNETIC EMISSIONS ....................................................................13
3.3.2 ELECTROMAGNETIC IMMUNITY ......................................................................14
3.4 CYBERSECURITY MEASURES ......................................................................................15
3.5 ENVIRONMENTAL RISKS AND DISPOSAL....................................................................16
3.6 SYMBOLS USED..............................................................................................................17
4. CLEANING AND DISINFECTION........................................................... 19
5. DESCRIPTION ........................................................................................ 20
5.1 IDENTIFICATION LABELS AND LASER LABELS...........................................................20
5.1.1 POSITION OF IDENTIFICATION LABELS..........................................................20
5.1.2 WARNING AND CAUTION LABELS ...................................................................21
5.2 FUNCTIONS, MODELS AND VERSIONS........................................................................22
6. TECHNICAL CHARACTERISTICS......................................................... 23
6.1 DIMENSIONS ...................................................................................................................29
6.2 TUBE LOADING CURVES, ANODE HEATING AND COOLING CURVES.....................32
6.3 PC REQUIREMENTS .......................................................................................................34
6.3.1 PC MINIMUM CHARACTERISTICS....................................................................34
6.3.2 PC SUGGESTED CHARACTERISTICS..............................................................35

User Manual - Contents
NIMXEN020I
Owandy Radiology SAS
6.4 SOFTWARE......................................................................................................................35
6.5 I-MAX 3D –PC COMMUNICATION .................................................................................35
6.6 REFERENCE STANDARD...............................................................................................36
6.7 CBCT CONDITIONS OF OPERATION ............................................................................38
6.7.1 REFERENCE PLANE ..........................................................................................38
6.8 CTDI INFORMATION........................................................................................................39
6.8.1 MEASURE CONDITIONS....................................................................................39
6.8.2 MEASUREMENT PROCEDURE .........................................................................39
6.8.3 MEASURED VALUES..........................................................................................40
6.8.4 MEASURED DOSE VALUES FOR OTHER CONDITIONS OF OPERATION....40
6.8.5 DOSE PROFILE...................................................................................................41
7. REMOVABLE PART LIST ...................................................................... 42
8. QUALITY ASSURANCE PROGRAM...................................................... 43
8.1 QUALITY CONTROL TOOLS...........................................................................................43
8.2 FUNCTIONING OF THE INDICATOR LIGHTS................................................................44
8.3 LASER ALIGNMENT CHECK...........................................................................................44
8.4 PANORAMIC IMAGE QUALITY CHECK..........................................................................45
8.4.1 LOG BOOK ..........................................................................................................48
8.5 3D IMAGE QUALITY CHECK...........................................................................................49
8.5.1 "QC TOOL" SOFTWARE.....................................................................................49
8.5.2 3D TEST IMAGE ACQUISITION .........................................................................51
8.5.3 NYQUIST FREQUENCY......................................................................................53
8.5.4 CONTRAST TO NOISE RATIO ...........................................................................53
8.5.5 SPATIAL RESOLUTION......................................................................................54
8.5.6 CT NUMBER........................................................................................................54
8.5.7 LENGTH AND WIDTH MEASURES....................................................................54
8.5.8 SLICE THICKNESS .............................................................................................54
8.5.9 HOMOGENEITY ..................................................................................................55
8.5.10 DOSE AT THE ISOCENTER ...............................................................................55
8.5.11 ACCEPTANCE INDEX.........................................................................................55
8.5.12 LOG BOOK ..........................................................................................................56
8.6 DOSIMETRY TEST (PARAGRAPH FOR AUTHORISED PERSONNEL)........................57
8.6.1 LOG BOOK ..........................................................................................................59
9. GENERAL INSTRUCTIONS FOR USE................................................... 60
9.1 SWITCHING THE DEVICE ON AND OFF........................................................................60
9.1.1 EMERGENCY BUTTON ......................................................................................61
9.2 POSITIONING THE CHIN SUPPORT..............................................................................62
9.3 KEYBOARD - DESCRIPTION AND FUNCTIONS............................................................65
9.4 GRAPHICAL USER INTERFACE - DESCRIPTION AND FUNCTIONS..........................67
9.4.1 MAIN GUI AREA FUNCTIONS............................................................................69
9.5 DIGITAL SENSOR............................................................................................................70

User Manual - Contents
NIMXEN020I
Owandy Radiology SAS
10. MAKING AN EXAM................................................................................. 71
10.1 ANATOMIC / MANUAL EXPOSURE................................................................................73
10.1.1 ANATOMIC EXPOSURE .....................................................................................74
10.1.2 MANUAL EXPOSURE .........................................................................................76
11. IMAGE PROCESSING WINDOW............................................................ 77
12. 2D EXAMS............................................................................................... 79
12.1 STANDARD PANORAMIC................................................................................................81
12.2 LEFT / RIGHT HALF PANORAMIC..................................................................................81
12.3 FRONTAL DENTITION.....................................................................................................81
12.4 LOW DOSE PANORAMIC................................................................................................81
12.5 ORTHO RAD DENTITION ................................................................................................82
12.6 SINGLE PHASE BITEWING (L/R)....................................................................................82
12.7 BILATERAL BITEWING....................................................................................................82
12.8 TMJ C/O............................................................................................................................83
12.9 TMJ SINGLE PHASE........................................................................................................83
12.10 SINUS ...............................................................................................................................83
13. 3D EXAMS............................................................................................... 84
13.1 3D FULL DENTITION .......................................................................................................84
13.2 3D SINUS..........................................................................................................................84
13.3 3D TMJ..............................................................................................................................84
13.4 3D SINGLE JAW...............................................................................................................84
13.5 3D MAXILLARY TEETH....................................................................................................85
13.6 3D MANDIBULAR TEETH................................................................................................85
13.7 3D EXTENDED VOLUME / 3D AIRWAYS .......................................................................85
13.8 DENTAL IMPRESSION / DENTAL MODEL SCAN..........................................................86
13.9 METAL ARTEFACT REDUCTION FILTER (MAR)...........................................................87
13.10 NEW RECONSTRUCTION...............................................................................................88
14. PATIENT POSITIONING......................................................................... 90
14.1 GENERAL RULES............................................................................................................90
14.2 2D EXAMS........................................................................................................................94
14.3 3D EXAMS........................................................................................................................94
15. ERROR MESSAGES............................................................................... 95
16. MAINTENANCE ...................................................................................... 98
17. PANORAMIC IMAGE ASSESSMENT .................................................... 99
17.1 PROPER POSITIONING OF THE PATIENT..................................................................100
17.2 PATIENT POSITIONING ERRORS................................................................................102
17.2.1 TURNED HEAD .................................................................................................102
17.2.2 TILTED HEAD....................................................................................................103

User Manual - Contents
NIMXEN020I
Owandy Radiology SAS
17.2.3 DOWNWARD ANGULATION OF THE HEAD...................................................104
17.2.4 BACKWARD ANGULATION OF THE HEAD.....................................................105
17.2.5 TONGUE EFFECT.............................................................................................106
17.2.6 SPINE EFFECT..................................................................................................107
Manufacturer OWANDY RADIOLOGY SAS has the right to modify products or their specifications
to improve performances, quality or reproducibility Product and its accessories specifications may
change without advice.
No part of this publication can be reproduced, transmitted, transcribed or translated without the
approval of Owandy Radiology SAS.
This manual in English is the original Manual version.
OWANDY RADIOLOGY SAS
2, rue des Vieilles Vignes
77183 Croissy-Beaubourg - FRANCE
Télèphone : +33 1.64.11.18.18
Fax : [phone]

User Manual - Introduction
NIMXEN020I
Owandy Radiology SAS
1
1. INTRODUCTION
Note
This manual is updated for the product it is sold with, to guarantee an adequate
reference for using the product properly and safely.
The manual may not reflect changes made to the product that do not affect operating
procedures or safety.
I-MAX 3D, manufactured by Owandy Radiology, is an X-ray device for the radiographic analysis
of the maxillo-facial complex.
I-MAX 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition and
Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Left and Bitewing Right, 2D Sinus and 2D
TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial
complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth,
Extended Volume), 3D Sinus, 3D TMJ and 3D Airways.
The aim of this Manual is to instruct the user on the safe and effective use of the device.
The device must be used complying with the procedures described in this Manual and never be
used for purposes other than those indicated herein.
Please read this Manual thoroughly before starting to use the unit; it is advisable to keep the
manual close to the device, for reference while operating.
I-MAX 3D is an electrical medical device and can only be used under the supervision of a
physician or of highly qualified personnel, with necessary knowledge of X-ray protection. The user
is liable for legal compliance in relation to the installation and operation of the device.
1.1 Icons appearing in the manual
This icon indicates a “NOTE”: please read the items marked by this icon thoroughly.
This icon indicates a “WARNING”: the items marked by this icon refer to safety aspects
of the patient and/or operator.

User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS
2
2. SPECIFICATION OF THE INTENDED USE
2.1 Application and medical purpose
I-MAX 3D is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two
dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of
teeth, jaw and oral structures.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams
are taken using cone shaped x-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care
professionals. It can be used with both paediatric and adult patients.
Caution
Federal law restricts this device to sale by or on the order of a dentist, a radiologist or another
legally qualified health care professional.
2.1.1 Intended patient population
I-MAX 3D system can be used with the following type of patient:
•Age: paediatric (from about 7 years) to geriatric
•Patient status:
self-sufficient patient (the patient can autonomously place himself as requested by the
physician)
non self-sufficient patient (the patient is assisted by medical personnel).
In any case the patient must be conscious, not anaesthetized and not incapacitated
•Nationality: multiple.
2.1.2 Operator Profile
This system may only be operated by persons who have suitable experience in radiation
protection or knowledge of radiation protection and who have been instructed in the operation of
the X-ray equipment.
2.1.3 Application environments
I-MAX 3D may be used in professional buildings (e.g. hospitals, private clinics) or in residential
buildings. For the purpose of EMC environment classification both installations are classified as
"Professional healthcare facility environment".
Note
In the radiographic room, direct audio and visual communication between operator and
patient shall be always possible. Otherwise, provide proper support (i.e. lead glass or
similar, interphone, etc.).

User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS
3
2.2 Applied parts
During normal use, I-MAX 3D is in contact with the patient via the handle, the chin rest and bite,
the temple clamp and the head strips for 3D exams, classified as Type B applied parts.
2.3 Typical doses delivered to the patient during extra-oral
exams
The dose per area of products delivered by I-MAX 3D to the patient during extra-oral exams is
indicated in the graphical user interface.
Note
The dosimetric indications result from the average of dose measures on a lot of X-
rays source assemblies.
The dose is taken at a certain distance from the focal spot of the X-ray source and then reported
to the imaging plane.
To get the DAP value, the dose on the imaging plane is multiplied by the X-ray field area measured
on the imaging sensor that is 52 cm far away from focal spot.
The typical size of the X-ray beam on the imaging sensor depends on the selected exam:
•for 2D exams:140 mm x 4.5 mm
•for 3D Dentition, 3D TMJ, 3D Sinus and Extended Volumes: 144 mm x 118.6 mm
•for 3D Dentition, 3D TMJ and 3D Sinus (FOV 80 x 80 mm): 122.9 mm x 109.9 mm (*)
•for Mandibular and Maxillary dentition: 77 mm x 118.6 mm
•for Mandibular and Maxillary dentition (FOV 80 x 50 mm): 77 mm x 109.9 mm (*)
•for 5x5 volumes is 73 mm x 69 mm
(*) values valid in case a 80 x 80 collimator (kit code 6604061200) is present
The distance between the focal spot and the patient skin is variable during the X-ray and on
average we can assume the mean distance between the focal spot and the patient skin as 264
mm.
The overall uncertainty of the indicated value of the air Kerma and dose per area product is 50%.
Note
As stated in IEC 60601-2-63, no deterministic effects are known with extra-oral dental
X-ray equipment.

User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS
4
2.3.1 Panoramic mode
The air kerma value at the entrance of the X-ray image receptor for the PANORAMIC exam is
reported in the table below as functions of kV and mA.
kV
60
62
64
66
68
70
72
74
76
78
80
82
84
86
mA
Air Kerma [mGy]
2
3.57
3.85
4.14
4.43
4.72
5.00
5.29
5.58
5.86
6.15
6.44
6.61
6.75
6.88
2.2
3.93
4.24
4.56
4.87
5.19
5.50
5.82
6.13
6.45
6.76
7.08
7.27
7.43
7.57
2.5
4.46
4.82
5.18
5.54
5.89
6.25
6.61
6.97
7.33
7.69
8.04
8.26
8.44
8.60
2.8
5.00
5.40
5.80
6.20
6.60
7.00
7.40
7.81
8.21
8.61
9.01
9.25
9.45
9.63
3.2
5.71
6.17
6.63
7.09
7.54
8.00
8.46
8.92
9.38
9.84
10.30
10.57
10.80
11.00
3.6
6.42
6.94
7.45
7.97
8.49
9.00
9.52
10.04
10.55
11.07
11.58
11.89
12.15
12.38
4
7.14
7.71
8.28
8.86
9.43
10.00
10.58
11.15
11.72
12.30
12.87
13.21
13.50
13.76
4.5
8.03
8.67
9.32
9.96
10.61
11.25
11.90
12.54
13.19
13.83
14.48
14.86
15.19
15.48
5
8.92
9.64
10.35
11.07
11.79
12.50
13.22
13.94
14.65
15.37
16.09
16.52
16.88
17.20
5.6
9.99
10.79
11.60
12.40
13.20
14.00
14.81
15.61
16.41
17.22
18.02
18.50
18.90
19.26
6.3
11.24
12.14
13.05
13.95
14.85
15.76
16.66
17.56
18.46
19.37
20.27
20.81
21.27
21.67
7.1
12.67
13.69
14.70
15.72
16.74
17.76
18.77
19.79
20.81
21.83
22.85
23.45
23.97
24.42
8
14.27
15.42
16.57
17.71
18.86
20.01
21.15
22.30
23.45
24.59
25.74
26.43
27.01
27.51
9
16.06
17.35
18.64
19.93
21.22
22.51
23.80
25.09
26.38
27.67
28.96
29.73
30.38
30.95
10
17.84
19.27
20.71
22.14
23.58
25.01
26.44
27.88
29.31
30.74
32.18
33.03
33.76
34.39
11
19.63
21.20
22.78
24.36
25.93
27.51
29.09
30.66
32.24
33.82
35.39
36.34
37.13
37.83
12.5
22.30
24.09
25.89
27.68
29.47
31.26
33.05
34.84
36.64
38.43
40.22
41.29
42.20
42.99

User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS
5
The air kerma for the other PANORAMIC exams available on the equipment can be calculated
using the ratios vs PANORAMIC EXAM in the table below:
Exam
Ratio
Half-panoramic
0.55
Low Dose
0.85
Ortho Rad panoramic
0.90
Frontal dentition
0.33
Bitewing L or R
0.24
Bitewing L and R
0.47
TMJ
0.71
Sinus
0.65

User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS
6
2.3.2 3D mode
The air kerma value at the entrance of the X-ray image receptor for the 3D exams is reported in
the table below as functions of kV and mA.
kV
60
62
64
66
68
70
72
74
76
78
80
82
84
86
mA
Air Kerma [mGy]
2
1.37
1.48
1.59
1.70
1.81
1.92
2.03
2.14
2.25
2.36
2.47
2.58
2.70
2.81
2.2
1.51
1.63
1.75
1.87
1.99
2.11
2.24
2.36
2.48
2.60
2.72
2.84
2.96
3.09
2.5
1.71
1.85
1.99
2.13
2.26
2.40
2.54
2.68
2.82
2.95
3.09
3.23
3.37
3.51
2.8
1.92
2.07
2.23
2.38
2.54
2.69
2.84
3.00
3.15
3.31
3.46
3.62
3.77
3.93
3.2
2.19
2.37
2.54
2.72
2.90
3.07
3.25
3.43
3.61
3.78
3.96
4.14
4.31
4.49
3.6
2.46
2.66
2.86
3.06
3.26
3.46
3.66
3.86
4.06
4.25
4.45
4.65
4.85
5.05
4
2.74
2.96
3.18
3.40
3.62
3.84
4.06
4.29
4.51
4.73
4.95
5.17
5.39
5.61
4.5
3.08
3.33
3.58
3.83
4.07
4.32
4.57
4.82
5.07
5.32
5.57
5.82
6.06
6.31
5
3.42
3.70
3.98
4.25
4.53
4.80
5.08
5.36
5.63
5.91
6.19
6.46
6.74
7.01
5.6
3.83
4.14
4.45
4.76
5.07
5.38
5.69
6.00
6.31
6.62
6.93
7.24
7.55
7.86
6.3
4.31
4.66
5.01
5.36
5.70
6.05
6.40
6.75
7.10
7.45
7.79
8.14
8.49
8.84
7.1
4.86
5.25
5.64
6.04
6.43
6.82
7.21
7.61
8.00
8.39
8.78
9.18
9.57
9.96
8
5.48
5.92
6.36
6.80
7.24
7.69
8.13
8.57
9.01
9.45
9.90
10.34
10.78
11.22
9
6.16
6.66
7.16
7.65
8.15
8.65
9.14
9.64
10.14
10.64
11.13
11.63
12.13
12.63
10
6.84
7.40
7.95
8.50
9.06
9.61
10.16
10.71
11.27
11.82
12.37
12.92
13.48
14.03
11
7.53
8.14
8.75
9.35
9.96
10.57
11.18
11.78
12.39
13.00
13.61
14.22
14.82
15.43
12.5
8.56
9.25
9.94
10.63
11.32
12.01
12.70
13.39
14.08
14.77
15.46
16.15
16.85
17.54
The air kerma for TMJs 3D exams can be calculated using the ratio vs 3D mode in the table
below:
Exam
Ratio
TMJ 3D
0.9

User Manual –Safety information
NIMXEN020I
Owandy Radiology SAS
7
3. SAFETY INFORMATION
Warning
Please read this chapter thoroughly.
Owandy Radiology designs and manufactures its devices in compliance with safety requirements;
furthermore, it supplies all information necessary for correct use, and warnings related to dangers
associated with X-ray generating units.
Owandy Radiology cannot be held liable for:
•Use of I-MAX 3D other than its intended use
•Damage to the unit, the operator or the patient, caused both by installation and
maintenance procedures other than those described in this Manual and in the Service
Manual supplied with the unit, and by erroneous operations
•Mechanical and/or electrical modifications performed during and after the installation,
other than those described in the Service Manual.
Installation and any technical operations must only be performed by qualified technicians
authorised by Owandy Radiology.
Only authorised personnel may remove the covers and/or have access to live components.
Warning
In compliance with the IEC 60601-1 standard, the modification of the equipment or its
parts is strictly prohibited.

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3.1 Warnings
The device must be used in compliance with the procedures described and never be used for
purposes other than those indicated herein.
Before performing any maintenance operation, disconnect the unit from the power supply.
I-MAX 3D is an electric medical device and so can only be used under the supervision of suitably
qualified medical personnel, with necessary knowledge of X-ray protection.
The user is responsible for compliance with legal requirements as regards ownership, installation
and use of the equipment.
The user is responsible for a safe set-up and maintenance of the host PC; as a general guidance
cybersecurity suggestions are given in paragraph 3.4 of this Manual.
The user is responsible for the execution of the routine quality control procedure described in
chapter 8 of this Manual.
This device has not been designed for use in environments where vapours, anaesthetic mixtures
flammable with air, or oxygen and nitrous oxide, may be present.
Do not let water, or other liquids, penetrate the device, as this could cause short circuits and
corrosion.
Before cleaning the device, make sure the main power supply has been disconnected from the
equipment. When pushing the ON/OFF button of the equipment, it must not come on.
Wherever necessary, use appropriate accessories, such as leaded aprons, to protect the patient
from radiation.
While performing the X-ray, no-one, apart from the operator and the patient, must remain in the
room.
I-MAX 3D has been built for continuous operation with an intermittent load; so the described use
cycles must be observed, to enable the device to cool down.
I-MAX 3D must be switched off while using electrosurgical devices or similar apparatus.
Warning
For safety reasons, the patient support arm must not be abnormally overloaded, for
example by leaning on it. The traction on the handle must be less than 16 kg.
Warning
To avoid the risk of electric shock, the equipment must only be connected to a mains
supply with earthing.
Clean and disinfect, when necessary, all parts that may come into contact with the patient.
The centring bite or the bite protective sleeve must be replaced after each exam.
To avoid permanent damage to the unit, never try to rotate the moving arm manually when the
unit is switched on.
In the case of Error 362, movement is possible to let the patient exit.
Note
When the unit is switched on, do not move the rotating arm.

User Manual –Safety information
NIMXEN020I
Owandy Radiology SAS
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3.1.1 Precautions while using laser centring devices
For patient positioning, I-Max 3D uses two laser diodes with optical power on the working surface
< 1 mW.
The directive CEI-EN 60825-1 defines the laser as "any device that produces or amplifies
electromagnetic radiation in a coherent manner which includes a wave lengths from 180 nm to 1
mm by means of a stimulated emission". In reference to this directive, the lasers present on the
I-Max 3D are parts of class 1.
A warning label (See picture below) is affixed to I-Max 3D to indicate a laser in class 1 is mounted
internally and caution is advised.
Warning
•Always keep the room well lit.
•Do not look into the output windows of laser centring units.
•Do not stare at the reflections of laser pointers.
•Instruct the patient to keep his/her eyes closed as long as the laser pointers are
active.
•Before starting an exam, the patient must remove earrings, glasses, necklaces and
any other item that could reflect the laser beam or be impressed on the
radiographic image.
•Do not clean the openings of laser centring devices with tools that could modify the
optics. Any cleaning must only be performed by authorized technicians.
•Operations other than those indicated could cause the emission of dangerous non-
ionizing radiation.

User Manual –Safety information
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Owandy Radiology SAS
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3.2 Protection against radiation
Although the dose supplied by dental X-ray units is quite low and distributed on a fairly small
surface, the operator must adopt precautions and/or suitable protection for the patient and
himself, during radiography.
Warning
Protection against radiation is regulated according to law.
The equipment may only be used by specialised personnel.
It is advisable to control the X-ray emission from a protected area, by remote control. If it is
necessary to operate near the patient, stay as far as the remote control cable allows, or at least
2 m both from the X-ray source and from the patient, as shown in the following figure.
Figure 1
Minimum distance from
X-ray source 2 m
Protected area