Villa Sistemi Medicali Rotograph EVO 3D User manual

Version 5 December 2011 (Rev. 1)
Rotograph EVO 3D 0051
Service Manual

SERVICE MANUAL
Revision history
(Rev. 1) Rotograph EVO 3D
Revision history
Rev. Date Page/s Modification description
0 24.03.11 - Document approval.
1 05.12.11 from i to vi,
from 3-1 to 3-18,
from 4-1 to 4-3,
4-8, 5-2, 6-10, 6-11,
6-12, from 6-22 to 6-27,
7-6, from 7-27 to 7-62,
from 9-20 to 9-36,
from 10-3 to 10-19,
from 10-77 to 10-83,
10-87, 10-89,
from 11-11 to 11-13
110-120V characteristics and identifications
labels added.
New handle for Ceph arm installation.
Axes alignment for the CEPH function
procedure improvement.
Number of projection doubled and exposure
time adjusted in 3D examination.
E831 description added in troubleshooting.
Schematics and drawings update.
Spare Parts update.
(Ref. RDM 7454, RDM 7473, RDM 7474, RDM 7501,
RDM 7502, RDM 7535, RDM 7578)

SERVICE MANUAL
Revision history
Rotograph EVO 3D (Rev. 1)
THIS PAGE IS INTENTIONALLY LEFT BLANK

SERVICE MANUAL
Contents
(Rev. 1) Rotograph EVO 3D
i
Contents
1. INTRODUCTION 1-1
1.1. Description of the system .................................................................... 1-2
1.2. Icons appearing in the manual ............................................................ 1-3
1.3. How to contact VILLA SISTEMI MEDICALI technical service ................ 1-3
2. SAFETY INFORMATION 2-1
2.1. Warnings ............................................................................................. 2-2
2.1.1. Distribution of stray radiation ..........................................................2-5
2.1.2. Electromagnetic emissions ...............................................................2-6
2.1.3. Electromagnetic immunity................................................................2-7
2.1.4. Recommended separation distances for non-life supporting
equipment........................................................................................2-9
2.2. Environmental risks and displacement .............................................. 2-10
2.3. Symbols used .................................................................................... 2-11
3. DESCRIPTION 3-1
3.1. Identification labels and laser labels .................................................... 3-1
3.1.1. Identification plates and laser labels "220-240V" version ...................3-2
3.1.2. Identification plates and laser labels "110-120V" version ...................3-3
3.2. Function, Models and Version ............................................................. 3-4
3.2.1. Basic version....................................................................................3-4
3.2.2. Version with cephalometric device ....................................................3-5
3.2.3. EVO XP (Extended Projection Package) - Optional .............................3-6
3.3. Block diagram ..................................................................................... 3-7
3.3.1. Power supply assembly.....................................................................3-8
3.3.2. CPU Board (A5 and A6) ....................................................................3-9
3.3.2.1. CPU Board jumper configuration.....................................3-10
3.3.3. Generator Board (A10) and Tubehead .............................................3-11
3.3.4. Keyboard (A4).................................................................................3-12
3.4. Control panel - Descriptions and functions........................................ 3-14
3.4.1. Key functions description ...............................................................3-17
4. TECHNICAL DATA 4-1
4.1. Separate parts supplied with Rotograph EVO 3D................................. 4-6
4.2. Applied safety regulations.................................................................... 4-8
4.3. Loading curve of the tube and cooling curve of the anode .................... 4-9
4.4. Measurement method of technical factors.......................................... 4-11
4.5. Dimensions........................................................................................ 4-12

SERVICE MANUAL
Contents
Rotograph EVO 3D (Rev. 1)
ii
5. PRE-INSTALLATION 5-1
5.1. Electrical setting up ............................................................................. 5-2
5.2. Packaging ............................................................................................ 5-5
5.3. Space requirements ............................................................................. 5-6
5.3.1. Version without CEPH...................................................................... 5-6
5.3.2. Version with CEPH........................................................................... 5-7
6. INSTALLATION 6-1
6.1. Setting of the wall ................................................................................ 6-2
6.2. Column mounting................................................................................ 6-3
6.3. Mounting of the rotating arm assembly................................................ 6-6
6.4. Mounting of CEPH-arm (Optional)...................................................... 6-11
6.5. How to mount the coverings............................................................... 6-13
6.6. Inserting the CEPH sensor in the sensor holder ................................. 6-14
6.7. Final checks ...................................................................................... 6-15
6.7.1. PC set up ....................................................................................... 6-15
6.7.1.1. PC – USB protection keys................................................ 6-15
6.7.1.2. PC - Rotograph EVO 3D communication ......................... 6-15
6.7.1.3. DICOM set-up ................................................................ 6-16
6.7.1.4. Image treatment filters setup .......................................... 6-17
6.7.2. Verification of the PANORAMIC function......................................... 6-18
6.7.3. Image verification for the 3D function ............................................. 6-21
6.7.4. Verification of the CEPH function ................................................... 6-22
6.7.5. Verification of exposure parameters................................................ 6-28
6.7.5.1. Invasive method.............................................................. 6-28
6.7.5.1.1. kVp ................................................................................ 6-31
6.7.5.1.2. mA Check ...................................................................... 6-32
6.7.5.1.3. Time............................................................................... 6-32
6.7.5.2. Non-invasive method ...................................................... 6-33
6.7.6. Storing of automatic exposure parameters ...................................... 6-35
6.7.6.1. Table of pre-set anatomic parameters.............................. 6-36
7. TROUBLESHOOTING 7-1
7.1. LEDs.................................................................................................... 7-1
7.1.1. Generator board A10 LED ................................................................ 7-1
7.1.2. CPU board A5 LED........................................................................... 7-2
7.2. Displayed messages ............................................................................. 7-3
7.2.1. Errors with code from E000 to E199................................................. 7-7
7.2.1.1. E108: Hardware key fault ................................................. 7-7
7.2.1.2. E110: Battery fault ........................................................... 7-7
7.2.2. Errors with code from E200 to E299................................................. 7-8
7.2.2.1. E200: Zero position optical sensor of rotation always active /
E201: Zero position optical sensor of rotation never active /
E204: Unexpected activation of zero position rotation
sensor ..............................................................................7-8

SERVICE MANUAL
Contents
(Rev. 1) Rotograph EVO 3D
iii
7.2.2.2. E205 Timeout on rotation .................................................7-9
7.2.2.3. E206 Patient collision .......................................................7-9
7.2.2.4. E240: Zero position sensor for Y axes always active /
E241: Zero position sensor for Y axes never active /
E242: Unexpected activation of Y axes /
E243: Timeout of Y axes..................................................7-10
7.2.2.5. E280: Unexpected activation of zero position sensor on
CEPH / E281: Timeout of zero position sensor on CEPH /
E282: Zero position sensor for CEPH never active /
E283: Zero position sensor for CEPH always active ..........7-11
7.2.3. Errors with code from E300 to E399...............................................7-12
7.2.3.1. E300: Unexpected activation of zero position sensor on
secondary CEPH collimator / E301: Timeout of zero
position sensor on secondary CEPH collimator /
E302: Zero position sensor for secondary CEPH collimator
never active / E303: Zero position sensor for secondary
CEPH collimator always active.........................................7-12
7.2.3.2. E320: Unexpected activation of zero position sensor on
primary collimator/ E321: Timeout of zero position
sensor on primary collimator / E322: Zero position sensor
for CEPH never primary collimator / E323: Zero position
sensor for CEPH always active collimator.........................7-13
7.2.3.3. E340: Sensor holder not in PAN position .........................7-15
7.2.3.4. E360 and E361: X-ray button pressed during power on ...7-16
7.2.3.5. E362: X-ray button released during the examination
procedure .......................................................................7-17
7.2.3.6. E380: Invalid CANBus message (from Generator CPU
board A9)........................................................................7-17
7.2.3.7. E381: Timeout on activating CAN protocol on Generator
board / E382: HF not answering to CAN protocol ............7-18
7.2.4. Errors with code from E400 to E499...............................................7-19
7.2.4.1. E400: Timeout of zero position sensor on Soft Tissue Filter /
E401: Zero position sensor for Soft Tissue Filter always
active..............................................................................7-19
7.2.5. Errors with code from E700 to E799...............................................7-20
7.2.5.1. E750: No power to the Generator board...........................7-21
7.2.5.2. E751: Over voltage kV.....................................................7-21
7.2.5.3. E752: Filament overload / E753: Overload on Anodic
current ...........................................................................7-22
7.2.5.4. E754: Broken filament ....................................................7-22
7.2.5.5. E756: PFC failure............................................................7-22
7.2.5.6. E755: Alarm “Backup timer intervention” /
E758: Alarm “No X-ray” / E759: Alarm “Unexpected
emission”........................................................................7-23
7.2.5.7. E760: Alarm "NO RX button command"...........................7-24
7.2.5.8. E762: Alarm "NO X-ray feedback"....................................7-24
7.2.5.9. E774: RX button not pressed ..........................................7-25
7.2.5.10. E775: RX button released during the emission ................7-25
7.2.6. Errors with code E800 and E801 ....................................................7-26
7.2.6.1. E800: Timeout on CAN activation for vertical motor .........7-26
7.2.6.2. E801: ON/OFF command for vertical motor not
changed on planned time ................................................7-26

SERVICE MANUAL
Contents
Rotograph EVO 3D (Rev. 1)
iv
7.2.7. E831: CPU board – VDSIB communication locked........................... 7-27
7.2.8. Errors with code E850, E851 and E852.......................................... 7-28
7.2.8.1. E850: More than one button pressed during power on..... 7-28
7.2.8.2. E851: Column up or Column down pressed at power on.. 7-28
7.2.8.3. E852: One key pressed during the movement .................. 7-29
7.3. Service programs descriptions ........................................................... 7-30
7.3.1. Accessing the service programs ...................................................... 7-31
7.3.2. General information on the use of keyboard.................................... 7-32
7.3.3. Password 92: Configuration menus ................................................ 7-33
7.3.3.1. Language........................................................................ 7-34
7.3.3.2. Date-Time set ................................................................. 7-35
7.3.3.3. Disable X-ray.................................................................. 7-36
7.3.3.4. Display brightness / Display contrast ............................. 7-36
7.3.3.5. LED brightness............................................................... 7-36
7.3.3.6. Key click sound / Key click volume ................................. 7-36
7.3.3.7. Manage pano opt. ........................................................... 7-37
7.3.3.8. Tooth style...................................................................... 7-38
7.3.3.9. Digital mode ................................................................... 7-39
7.3.3.10. COLL Setup type ............................................................ 7-39
7.3.3.11. STF Setup type ............................................................... 7-39
7.3.3.12. Sensor handling ............................................................. 7-40
7.3.3.13. DSPU IP address............................................................. 7-41
7.3.3.14. DSPU NET mask............................................................. 7-41
7.3.3.15. QSD IP address .............................................................. 7-41
7.3.3.16. QSD NET mask............................................................... 7-41
7.3.3.17. Enable 3D Sensor ........................................................... 7-41
7.3.4. Password 118: Axis alignment menu .............................................. 7-42
7.3.4.1. Rotation zero .................................................................. 7-44
7.3.4.2. Y Axis zero...................................................................... 7-45
7.3.4.3. Cassette zero .................................................................. 7-45
7.3.4.4. Primary collimator PAN................................................... 7-46
7.3.4.5. Primary collimator 3D..................................................... 7-47
7.3.5. Password 124: CEPH settings......................................................... 7-48
7.3.5.1. Enable sensor................................................................. 7-49
7.3.5.2. Y Offset .......................................................................... 7-50
7.3.5.3. Rotation offset ................................................................ 7-51
7.3.5.4. Lining up test ................................................................. 7-51
7.3.5.5. CEPH secondary collimator zero...................................... 7-52
7.3.5.6. CEPH sensor zero ........................................................... 7-53
7.3.5.7. STF zero ......................................................................... 7-53
7.3.6. Password 112: Troubleshooting ...................................................... 7-54
7.3.6.1. Test column.................................................................... 7-55
7.3.6.2. Test input ports .............................................................. 7-56
7.3.6.3. Pre-heating time ............................................................. 7-58
7.3.6.4. Preheating level .............................................................. 7-59
7.3.6.5. PAN RX emission / CEPH RX emission............................ 7-60
7.3.7. System / Burn-in........................................................................... 7-61
7.3.8. Show configuration ........................................................................ 7-61

SERVICE MANUAL
Contents
(Rev. 1) Rotograph EVO 3D
v
8. PERIODIC MAINTENANCE 8-1
8.1. Service tools ........................................................................................ 8-3
8.2. Detector Calibration............................................................................. 8-4
9. CORRECTIVE MAINTENANCE 9-1
9.1. 3D Digital sensor replacement ............................................................. 9-1
9.1.1. Calibration file installation ...............................................................9-1
9.1.2. PLEORA PCB communication address enabling
(Pleora Mac address).........................................................................9-2
9.1.3. PLEORA PCB communication set up.................................................9-3
9.2. 3D Digital sensor or Tubehead replacement......................................... 9-4
9.2.1. Panoramic X-ray beam centering verification ....................................9-4
9.2.2. 3D image adjustment .....................................................................9-10
9.3. CPU board replacement ..................................................................... 9-12
9.4. CEPH Digital sensor replacement ...................................................... 9-14
9.5. PC replacement.................................................................................. 9-14
9.5.1. Software package ...........................................................................9-14
9.5.2. Dental Studio installation...............................................................9-15
9.5.3. 3D Sensor calibration files installation............................................9-16
9.5.4. CEPH Sensor Calibration file installation ........................................9-16
9.5.5. Internal network set up ..................................................................9-17
9.5.5.1. Direct point-to-point connection between PC and
Rotograph EVO 3D..........................................................9-19
9.6. CEPH arm aligment ........................................................................... 9-20
9.6.1. Ear rings alignment........................................................................9-22
9.6.2. CEPH Sensor centering ..................................................................9-27
9.6.3. Secondary collimator centering....................................................... 9-29
9.6.4. Soft Tissue Filter (STF) adjustment ................................................. 9-33
10. SCHEMATICS AND DRAWINGS 10-1
11. SPARE PARTS 11-1
12. APPENDIX A-1
12.1.Appendix A: Setup parameters table .................................................... A-1
This publication can only be reproduced, transmitted, transcribed or translated into
any human or computer language with the written consent of VILLA SISTEMI
MEDICALI S.p.a.
This manual in English is the original version.

SERVICE MANUAL
Contents
Rotograph EVO 3D (Rev. 1)
vi
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SERVICE MANUAL
Introduction
(Rev. 0) Rotograph EVO 3D
1-1
1. INTRODUCTION
NOTE:
The present manual is updated for the product it is sold with in order to
grant an adequate reference in performing diagnostics and repair
operations normally carried out by the service engineer.
The manual may not reflect changes to the product not impacting service
operations.
This manual provides to the technical personnel the instructions for
proper and safe installation and maintenance of the appliance.
This manual is limited to the description of the X-ray device; instruction
on the Digital Acquisition System are given in the relevant Manuals,
supplied with the Direct Digital Sensor.
WARNING:
1. Rotograph EVO 3D is an electro-medical device and it can be used
only under the supervision of a physician or of highly qualified
personnel, with the necessary knowledge on X-ray protection.
2. The device must be used in compliance with the procedures
described, and never be used for purposes different from those
herewith indicated.
3. The user is liable as concerns the legal fulfilment related to the
installation and the operation of the device.
*

SERVICE MANUAL
Introduction
Rotograph EVO 3D (Rev. 0)
1-2
1.1. Description of the system
The evolution of panoramic X-ray provides, in addition to traditional
methods of examination (Panoramic, TMJ, Sinus, etc.). the use of three-
dimensional images of the patient's maxillofacial complex, so as to allow
the doctor the targeted selection of the procedures to use, both during
the planning phase of the treatment as well as diagnosis aid.
Rotograph EVO 3D, produced by VILLA SISTEMI MEDICALI S.p.A., is a
complete panoramic system that allows the execution of all X-rays
commonly used in dentistry and orthodontics (excluding intraoral
radiographs) and also allows the acquisition of volumetric tomographic or
3D X-rays.
In this type of device, the linear digital sensor traditionally used in the
digital panoramic X-rays has been replaced by a wide range Digital
Sensor, also known as the Flat Panel.
These sensors allow to capture an area of the maxillofacial complex that
include the most important anatomical details, by acquiring a series of
two-dimensional images (imaging).
The following options are available that must be ordered separately:
• EVO XP (Additional projection package); allows to perform the
following examinations: Emi-panoramic, Improved orthogonality
dentition, reduced dose Panoramic and Frontal dentition.
• DIGITAL CEPH; allows the execution of the following exams, available
in High Resolution mode or Normal Resolution (high speed):
- CEPH exam in different formats
- CARPUS exam.

SERVICE MANUAL
Introduction
(Rev. 0) Rotograph EVO 3D
1-3
1.2. Icons appearing in the manual
This icon indicates a NOTE; please read thoroughly the items marked
by this picture.
This icon indicates a WARNING message; the items marked by this
icon refer to the safety aspects of the patient and/or of the operator.
1.3. How to contact VILLA SISTEMI MEDICALI technical
service
For any technical queries please contact the following:
• Telephone number +39 02 48859.1
• Fax number [phone]
• E-mail: [e-mail]
*

SERVICE MANUAL
Introduction
Rotograph EVO 3D (Rev. 0)
1-4
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SERVICE MANUAL
Safety information
(Rev. 0) Rotograph EVO 3D
2-1
2. SAFETY INFORMATION
WARNING:
Please read this chapter thoroughly.
Villa Sistemi Medicali designs and builds its devices complying with the
related safety requirements; furthermore it supplies all information
necessary for a correct use and the warnings related to danger associated
with X-rays generating units.
Villa Sistemi Medicali, has not to be held responsible for:
• use of Rotograph EVO 3D different than the intended use,
• damages to the unit, to the operator, to the patient, caused both by
installation and maintenance procedures different than those
described in this Manual and/or by wrong operations,
• mechanical and/or electrical modifications performed during and
after the installation, different than those described in this Manual.
Installation and any technical intervention must only be performed
by qualified technicians authorized by Villa Sistemi Medicali.
Only the authorised personnel can remove the covers and/or have
access to the components under tension.
In compliance with the IEC 60601-1 standard, the modification of
the equipment or its parts is strictly prohibited.

SERVICE MANUAL
Safety information
Rotograph EVO 3D (Rev. 0)
2-2
2.1. Warnings
Rotograph EVO 3D must be used in dental surgeries, radiology and
hospital settings.
This device has not been designed to be used in environments where
vapours, anaesthetic mixtures flammable with air, or oxygen and nitrous
oxide, can be detected.
Do not let water, or other liquids, into the device, as this could cause
short-circuits and corrosion.
Before cleaning the device, please disconnect it from the line voltage.
Wherever necessary, use the appropriate accessories, such as the leaded
aprons, to protect the patient from radiation.
While performing the radiography, no-one, apart from the operator and
the patient, must remain in the room.
Rotograph EVO 3D has been built to support a continuous operation at
intermittent load; therefore please follow the described use cycles to
enable the device to cool down.
Rotograph EVO 3D must be switched off while using devices such as
electrosurgical devices or similar apparatus.
Clean and disinfect all parts that come into contact with the patient.
The centring bite or the bite protective sleeve, the head strip for 3D
examinations and the ear centring devices of the Cephalostat must
be replaced after each examination in which they were used.
Never try to rotate the moving arm manually when the unit is
switched on, to avoid permanent damage to the unit.
The manual movement is only allowed in case of error 206 (no power to
motors) to allow the exit of the patient.
Although the dose supplied by dental X-ray units is quite low and
distributed on a small surface, the operator must adopt the precautions
and/or suitable protection for the patient and himself, during the
execution of radiography. It is advisable to control the X-ray emission
from a protected area, by means of a 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 Figure 2-1 and Figure 2-2.

SERVICE MANUAL
Safety information
(Rev. 0) Rotograph EVO 3D
2-3
Minimum distance from
X-ray source 2 m
Protected area
Figure 2-1 - Panoramic version
Minimum distance from
X-ray source 2 m
Protected area
Figure 2-2 - Cephalometric version

SERVICE MANUAL
Safety information
Rotograph EVO 3D (Rev. 0)
2-4
WARNING:
The network connector on the base of the Rotograph EVO 3D column
must be connected to the dedicated image acquisition and 3D and
panoramic reconstruction PC via a shielded Ethernet cable "Cat.5e" or
greater.
Do not use this connector to connect the Rotograph Evo 3D to LAN
networks.
NOTE:
The dimension of the "patient's environment" is defined as a distance of
at least 1.5 m from the actual patient.
If the PC is positioned inside the patient's environment, it must conform
to the requirements specified by the IEC 60601-1 standard for medical
devices; if located outside of the patient's environment, it must be
compliant with the IEC 60950 standard.
If the PC is supplied by Villa (optional), it must be placed outside the
patient's environment.
NOTE:
Do not apply movements to the rotating arm or the tube-head when
the equipment is on.
WARNING: PRECAUTIONS DURING INSTALLATION AND SERVICE
INTERVENTIONS
• Please take the highest care while mounting the column to the wall
and strictly follow the instructions listed in this manual.
• Before removing the covers of the column, or before removing the
covers of the Generator board (A10), disconnect the power supply to
the device, both switching the main switch and the magneto-thermal
differential off, and wait at least 2 minutes.
• When the device is supplied without the above mentioned coverings,
pay the highest attention since high voltage is generated in the
supply unit, and the voltage is at about 400 Vdc on the Generator
board. This is indicated by the green LED H1. Should the LED be off
and before any other intervention, disconnect the device from the net,
wait at least 2 minute, then check the fuses F1 (10AF) in the supply
unit, or F2 (5AF) on the Generator board (see circuit diagram).
• Each intervention must be performed after having disconnected the
device from the supply net and after LED H1 is OFF. It is anyway
advisable to wait at least 2 minutes from the LED's switching off.
• The system construction does not allow the repair of
faulty/damaged parts, that must be replaced using original spare
parts supplied by Villa Sistemi Medicali. Only trained personnel
are authorized to make service interventions on the unit,
following the instructions contained in this manual.
*
*

SERVICE MANUAL
Safety information
(Rev. 0) Rotograph EVO 3D
2-5
2.1.1. Distribution of stray radiation
-1.5 -1 -0.5 0 0.5 1 1.5m
1.5m 0.02 0.02 0.03 0.03 0.03 0.03 0.02 1.5m
1 0.025 0.03 1
0.5 0.03 0.08 0.065
0.02 0.5
0 0.03
0.004 0
-0.5 0.03 0.09 0.08
0.01 -0.5
-1 0.03
0.02 -1
-1.5 0.02 0.03 0.03 0.04 0.03 0.025 0.02 -1.5
-1.5 -1 -0.5 0 0.5 1 1.5m
Figure 2-3: Distribution of stray radiation
Figure 2-3 illustrates the distribution of stray radiation in the horizontal
plane at the centre of rotation of the scanning unit in the area of a
3 x 3 m rectangle.
The measurement was performed using a cylindrical phantom with a
diameter of 320 mm and length of 140 mm placed in the centre of
rotation of the scanning unit, with the "3D Dentition" examination mode
and the following parameters set: 86 kV, 10 mA, 8 s.
The distribution values in the table are expressed as air Kerma for mAs
(µGy/mAs).
C

SERVICE MANUAL
Safety information
Rotograph EVO 3D (Rev. 0)
2-6
2.1.2. Electromagnetic emissions
In accordance with the IEC 60601-1-2 standard, the Rotograph EVO 3D
is suitable for use in the specified electromagnetic environment.
The purchaser or user of the system should assure that it is used in an
electromagnetic environment as described below.
Emissions test Compliance Electromagnetic environment
Group I Rotograph EVO 3D uses RF energy only for its
the internal function. Therefore, the R.F.
emissions is very low and not likely to cause any
interference in nearby electronic equipment.
CISPR 11
Class B+12 Rotograph EVO 3D is suitable for use in
domestic establishments and in establishments
directly connected to the low voltage power
supply network which supplies buildings used
for domestic purposes.
Harmonics emissions
IEC 61000-3-2
Class A Rotograph EVO 3D is suitable for use in
domestic establishments and in establishments
directly connected to the low voltage power
supply network which supplies buildings used
for domestic purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies Rotograph EVO 3D is suitable for use in
domestic establishments and in establishments
directly connected to the low voltage power
supply network which supplies buildings used
for domestic purposes.

SERVICE MANUAL
Safety information
(Rev. 0) Rotograph EVO 3D
2-7
2.1.3. Electromagnetic immunity
In accordance with the IEC 60601-1-2 standard, the Rotograph EVO 3D
is suitable for use in the specified electromagnetic environment.
The purchaser or user of the system should assure that it is used in an
electromagnetic environment as described below.
Immunity test IEC 60601-1-2
Test level
Compliance
level
Electromagnetic
environment
Electrostatic
discharges (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
Test level
IEC 60601-1-2
Residential/Hospital
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power supply
lines
1 kV for input/output
lines > 3 m
Test level
IEC 60601-1-2
Residential/Hospital
Surge
IEC 61000-4-5
1 kV differential mode
2 kV common mode
Test level
IEC 60601-1-2
Residential/Hospital
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
0 % Unfor 0.5 cycles
40 % Unfor 5 cycles
70 % Unfor 25 cycles
0 % Unfor 5 s
Test level
IEC 60601-1-2
Residential/Hospital
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m Test level
IEC 60601-1-2
Residential/Hospital
Immunity test IEC 60601-1-2
Test level
Compliance
level Electromagnetic environment
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Rotograph EVO 3D, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m d = 1.2 x
√ P 80 MHz to 800 MHz
d = 2.3 x
√ P 800 MHz to 2.5 GHz