Technical Publication: Direction 5125914-100 Revision 7 GE Healthcare EMC Compliance Statement

GE Healthcare
gehealthcare.com
Technical
Publication
Direction 5125914-100
Revision 7
GE Healthcare
EMC Compliance Statement
For Products:
AMX4+
Precision 500D
Revolution XR/d - 2X
Definium 8000
Definium AMX 700
Copyright © 2004 by General Electric Company, Inc.

All rights reserved.
GE HEALTHCARE EMC COMPLIANCE STATEMENT
REVISION 7 DIRECTION 5125914-100
THIS PAGE LEFT INTENTIONALLY BLANK
Published by the GE Company, Inc.

CEM Editor/Integrator: Rick Fauska
Engineering/Technical: Dan Beetcher
Page 2
LEGAL NOTES
TRADEMARKS
All products and their name brands are trademarks of their respective holders.
COPYRIGHTS
All Material, Copyright © 2004 by General Electric Company, Inc. All rights reserved.
Revision History
Revision Date Reason for change

1 October 22, 2004 Initial release.
2 October 29, 2004 Precision 500D added.
3 November 1, 2004 Revolution XR/d 2X Platform added.
4 November 10, 2004 Updated AMX, P500 and XR/d 2X: Spelling, formatting and
accuracy checked.
5 November 9, 2005 Definium 8000 added.
6 December 16, 2005 Updated Table 4-3 to add Definium 8000 data. Added new
chapter for Definium AMX 700;
7 April 28, 2006 Updated Definium AMX 700 section.
LIST OF AFFECTED PAGES

PAGES REVISION PAGES REVISION
1 through 38 7
Revision History Page 3

Page 4 List of Effected Pages

IMPORTANT PRECAUTIONS
LANGUAGE
• THIS SERVICE MANUAL IS AVAILABLE IN ENGLISH ONLY.

• IF A CUSTOMER’S SERVICE PROVIDER REQUIRES A LANGUAGE OTHER THAN
ENGLISH, IT IS THE CUSTOMER’S RESPONSIBILITY TO PROVIDE TRANSLATION
SERVICES.
• DO NOT ATTEMPT TO SERVICE THE EQUIPMENT UNLESS THIS SERVICE MANUAL
HAS BEEN CONSULTED AND IS UNDERSTOOD.
• FAILURE TO HEED THIS WARNING MAY RESULT IN INJURY TO THE SERVICE
PROVIDER, OPERATOR OR PATIENT FROM ELECTRIC SHOCK, MECHANICAL OR
OTHER HAZARDS.
• CE MANUEL DE MAINTENANCE N’EST DISPONIBLE QU’EN ANGLAIS.

• SI LE TECHNICIEN DU CLIENT A BESOIN DE CE MANUEL DANS UNE AUTRE LANGUE
QUE L’ANGLAIS, C’EST AU CLIENT QU’IL INCOMBE DE LE FAIRE TRADUIRE.
• NE PAS TENTER D’INTERVENTION SUR LES ÉQUIPEMENTS TANT QUE LE MANUEL
SERVICE N’A PAS ÉTÉ CONSULTÉ ET COMPRIS.
• LE NON-RESPECT DE CET AVERTISSEMENT PEUT ENTRAÎNER CHEZ LE
TECHNICIEN, L’OPÉRATEUR OU LE PATIENT DES BLESSURES DUES À DES
DANGERS ÉLECTRIQUES, MÉCANIQUES OU AUTRES.
• DIESES KUNDENDIENST-HANDBUCH EXISTIERT NUR IN ENGLISCHER SPRACHE.

• FALLS EIN FREMDER KUNDENDIENST EINE ANDERE SPRACHE BENÖTIGT, IST ES
AUFGABE DES KUNDEN FÜR EINE ENTSPRECHENDE ÜBERSETZUNG ZU SORGEN.
• VERSUCHEN SIE NICHT, DAS GERÄT ZU REPARIEREN, BEVOR DIESES
KUNDENDIENST-HANDBUCH ZU RATE GEZOGEN UND VERSTANDEN WURDE.
• WIRD DIESE WARNUNG NICHT BEACHTET, SO KANN ES ZU VERLETZUNGEN DES
KUNDENDIENSTTECHNIKERS, DES BEDIENERS ODER DES PATIENTEN DURCH
ELEKTRISCHE SCHLÄGE, MECHANISCHE ODER SONSTIGE GEFAHREN KOMMEN.
• ESTE MANUAL DE SERVICIO SÓLO EXISTE EN INGLÉS.

• SI ALGÚN PROVEEDOR DE SERVICIOS AJENO A GEMS SOLICITA UN IDIOMA QUE
NO SEA EL INGLÉS, ES RESPONSABILIDAD DEL CLIENTE OFRECER UN SERVICIO
DE TRADUCCIÓN.
• NO SE DEBERÁ DAR SERVICIO TÉCNICO AL EQUIPO, SIN HABER CONSULTADO Y
COMPRENDIDO ESTE MANUAL DE SERVICIO.
• LA NO OBSERVANCIA DEL PRESENTE AVISO PUEDE DAR LUGAR A QUE EL
PROVEEDOR DE SERVICIOS, EL OPERADOR O EL PACIENTE SUFRAN LESIONES
PROVOCADAS POR CAUSAS ELÉCTRICAS, MECÁNICAS O DE OTRA NATURALEZA.
- Page 5
• ESTE MANUAL DE ASSISTÊNCIA TÉCNICA SÓ SE ENCONTRA DISPONÍVEL EM

INGLÊS.
• SE QUALQUER OUTRO SERVIÇO DE ASSISTÊNCIA TÉCNICA, QUE NÃO A GEMS,
SOLICITAR ESTES MANUAIS NOUTRO IDIOMA, É DA RESPONSABILIDADE DO
CLIENTE FORNECER OS SERVIÇOS DE TRADUÇÃO.
• NÃO TENTE REPARAR O EQUIPAMENTO SEM TER CONSULTADO E
COMPREENDIDO ESTE MANUAL DE ASSISTÊNCIA TÉCNICA.
• O NÃO CUMPRIMENTO DESTE AVISO PODE POR EM PERIGO A SEGURANÇA DO
TÉCNICO, OPERADOR OU PACIENTE DEVIDO A‘ CHOQUES ELÉTRICOS,
MECÂNICOS OU OUTROS.
• IL PRESENTE MANUALE DI MANUTENZIONE È DISPONIBILE SOLTANTO IN INGLESE.

• SE UN ADDETTO ALLA MANUTENZIONE ESTERNO ALLA GEMS RICHIEDE IL
MANUALE IN UNA LINGUA DIVERSA, IL CLIENTE È TENUTO A PROVVEDERE
DIRETTAMENTE ALLA TRADUZIONE.
• SI PROCEDA ALLA MANUTENZIONE DELL’APPARECCHIATURA SOLO DOPO AVER
CONSULTATO IL PRESENTE MANUALE ED AVERNE COMPRESO IL CONTENUTO.
• NON TENERE CONTO DELLA PRESENTE AVVERTENZA POTREBBE FAR COMPIERE
OPERAZIONI DA CUI DERIVINO LESIONI ALL’ADDETTO ALLA MANUTENZIONE,
ALL’UTILIZZATORE ED AL PAZIENTE PER FOLGORAZIONE ELETTRICA, PER URTI
MECCANICI OD ALTRI RISCHI.
Page 6 -
GGE HEALTHCARE EMC COMPLIANCE STATEMENT
Table of Contents
Chapter 1 - Introduction.......................................................................................... 9
Chapter 2 - AMX 4+ Product ................................................................................. 11

Section 1.0 - Compliance Statement .............................................................. 11
Section 2.0 - Compatibility Tables .................................................................. 11
2.1 Electromagnetic Emission ............................................................................................... 12
2.2 Electromagnetic Immunity ............................................................................................... 13
Section 3.0 - Use Recommendations ............................................................. 15
Section 4.0 - Installation Recommendations ................................................. 16
4.1 Cable Shielding & Grounding .......................................................................................... 16
4.2 Subsystem & Accessories Power Supply Distribution .................................................... 16
4.3 Stacked Components & Equipment................................................................................. 16
4.4 Low Frequency Magnetic Field........................................................................................ 16
4.5 Static Magnetic Field Limits ............................................................................................. 16
4.6 Electrostatic Discharge Environment & Recommendations ............................................ 16
Chapter 3 - Precision 500D Product .................................................................... 17

4.4 Low Frequency Magnetic Field........................................................................................ 22
4.5 Static Magnetic Field Limits ............................................................................................. 22
4.6 Electrostatic Discharge Environment & Recommendations ............................................ 22
Chapter 4 - Revolution XR/d & Definium 8000 Products ................................... 23

Table of Contents Page 7

4.4 Low Frequency Magnetic Field ....................................................................................... 30
4.5 Static Magnetic Field Limits ............................................................................................ 30
4.6 Electrostatic Discharge Environment & Recommendations............................................ 30
Chapter 5 - Definium AMX 700 Product .............................................................. 31

Section 1.0 - Compliance Statement............................................................... 31
2.1 Electromagnetic Emission............................................................................................... 32
2.2 Electromagnetic Immunity............................................................................................... 33
Section 3.0 - Use Recommendations.............................................................. 35
4.1 Cable Shielding & Grounding.......................................................................................... 36
4.2 Subsystem & Accessories Power Supply Distribution ................................................... 36
4.3 Stacked Components & Equipment ................................................................................ 36
4.4 Low Frequency Magnetic Field ....................................................................................... 36
4.5 Static Magnetic Field Limits ............................................................................................ 36
4.6 Electrostatic Discharge Environment & Recommendations............................................ 36
Page 8 Table of Contents

Chapter 1 - Introduction
This document specifies the Electromagnetic Compatibility (EMC) for the following products:
• AMX 4+
• Precision 500D
• Revolution XR/d
• Definium 8000
• Definium AMX 700
For each product, there are Compliance Statements, Compatibility Tables, Use Recommendations
and Installation Recommendations.
Chapter 1 - - Introduction Page 9

Page 10 -
Chapter 2 - AMX 4+ Product
Section 1.0 - Compliance Statement

This equipment complies with IEC 60601-1-2 Edition 2 (2001) EMC standard for medical devices.
Exception: IEC 61000-4-21 test method was performed at the standard test level, standard
frequencies, and using standard modulation in place of the permissible abbreviated IEC 61000-4-
3 test method.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical and non-medical devices and radio
communications.
To provide reasonable protection against such interference, this product complies the radiated
emission as per CISPR11 Group1 Class A standard limits.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment
on and off), the user (or qualified service personnel) should attempt to correct the problem by one
or more of the following measure(s):
• Reorient or relocate the affected device(s)
• Increase the separation between the equipment and the affected device (see recommended
separation distances)
• Power the equipment from a source different from that of the affected device
• Consult the point of purchase or service representative for further suggestions
The manufacturer is not responsible for any interference caused by using other than recommended
interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized
changes or modifications could void the users' authority to operate the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded, except when
technologically prohibited. Use of cables not properly shielded and grounded may result in the
equipment causing radio frequency interference.
The AMX 4+ is predominantly intended for use in non-domestic environments, and not directly
connected to the Public Mains Network that supplies buildings used for domestic purposes.
The optional Dose Area Product (DAP) and other compatible accessories must be used within the
recommended operating conditions outlined in the operation manuals. In addition to calibration and
warm-up, the DAP and other devices must be reset before and after use to ensure accurate dose
measurements. Sustained exposure to electromagnetic fields (exceeding the test conditions) may
cause false measurements. Failure to follow the recommended use may cause false
measurements.
The magnetic field environment from a MRI device located nearby is a risk of interference.
All of the above are required to achieve the Electromagnetic Compatibility for a typical installation
of the AMX 4+. Further detailed data & requirements are described in the Use Recommendations
and Installation Recommendations sections.
Section 2.0 - Compatibility Tables

The AMX 4+ is suitable to be used in an electromagnetic environment, as per the limits &
recommendations described in the tables hereafter:
Chapter 2 - - AMX 4+ Product Page 11

• Emission Compliance level & limits (Table 2-1).
• Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 2-2 and Table 2-3).
Note: This system complies with above mentioned EMC standard when used with supplied cables.
If different cable lengths are required, contact a qualified service representative for advice.
2.1 Electromagnetic Emission
Guidance and manufacturer’s declaration – Electromagnetic Emissions

The AMX 4+ is intended for use in the electromagnetic environment specified below. The customer
or the user of the AMX 4+ should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
The AMX 4+ uses RF energy only for its internal
RF emissions, function. Therefore, its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any interference in nearby
electronic equipment.
RF emissions,
Class A The AMX 4+ is predominantly intended for use in non-
CISPR 11
domestic environments, and not directly connected to
Harmonic the Public Mains Network. The AMX 4+ is predominantly
emissions, Class A intended for use (e.g. in hospitals) with an appropriate
IEC 61000-3-2 power supply (see operation manual) and the
Voltage fluctuations/ recommended shielding for portable use.
flicker emissions, Complies
IEC 61000-3-3
Table 2-1 AMX 4+ Electromagnetic Emission
Page 12 Section 2.0 - - Compatibility Tables

2.2 Electromagnetic Immunity
Guidance and Manufacturer’s declaration – electromagnetic immunity.

The AMX 4+ is intended for use in the electromagnetic environment specified below. The customer or the user of the
AMX 4+ should assure that it is used in such an environment.
Electromagnetic Environment
Immunity Test IEC 60601-1-2 Test Level Compliance Level
Guidance
Floors should be wood,
Electrostatic +/− 6 kV contact. +/− 6 kV contact. concrete, or ceramic tile. If floors
discharge (ESD), are covered with synthetic
IEC 61000-4-2 +/− 8 kV air. +/− 8 kV air. material, the relative humidity
should be at least 30%.
+/− 2 kV for power supply +/− 2 kV for power supply
Electrical fast lines. lines. Mains power quality should be
transient/burst, that of a typical commercial or
EC 61000-4-4 +/− 1 kV for input/output +/− 1 kV for input/output hospital environment
lines. lines.
+/− 1 kV line(s) to line(s). +/− 1 kV line(s) to line(s). Mains power quality should be
Surge, IEC 61000-4-5 that of a typical commercial or
+/− 2 kV line(s) to earth. +/− 2 kV line(s) to earth. hospital environment.
< 5% UTa, (> 95% dip in Mains power quality should be

< 5% UTa, (> 95% dip in
that of a typical commercial or
UT) for 0.5 cycle. UT) for 0.5 cycle.
Voltage dips, short hospital environment. If the user
interruptions and 40% UT, (60% dip in UT) 40% UT, (60% dip in UT) of the AMX 4+ requires
voltage variations on for 5 cycles. for 5 cycles. continued operation during
power supply input 70% UT, (30% dip in UT) 70% UT, (30% dip in UT) power mains interruptions, it is
lines, IEC 61000-4- recommended that the AMX 4+
for 25 cycles. for 25 cycles.
11 be powered from an
< 5% UT, (> 95% dip in UT) < 5% UT, (> 95% dip in UT) uninterruptible power supply or
for 5 sec. for 5 sec. a battery.
Power frequency magnetic
Power frequency (50/ fields should be at levels
60 Hz) magnetic 3 A/m 3 A/m characteristic of a typical
field, IEC 61000-4-8 location in a typical commercial
or hospital environment.
Table 2-2 AMX 4+ Electromagnetic Immunity

a. UT is the a.c. mains voltage prior to application of the test level.

Guidance and Manufacturer’s declaration - electromagnetic immunity. The AMX 4+ is suitable for use in the specified
electromagnetic environment. The customer or the user of the AMX 4+ should assure that it is used in an electromagnetic
environment as described below.
IEC 60601-1-2 Compliance
Immunity Test Electromagnetic Environment Guidance
Test Level Level
Portable and mobile RF communications equipment
should be used no closer to any part of the AMX 4+,
including cables, than the recommended separation
distance calculated from the equation appropriate for
the frequency of the transmitter.
Recommended Separation Distance
3,5
d=[ ] P
V1
3,5
d=[ ] P
E1 80 MHz to 800 MHz
7
Conducted RF, 3 Vrms, 150 kHz V1 = 3Vrms d =[ ] P
IEC 61000-4-6 to 80 MHz E1 800 MHz to 2.5 GHz
where, P is the maximum output power rating of the
Radiated RF 3 V/m, 80 MHz to E1 = 3V/m transmitter in watts (W) according to the transmitter
IEC 61000-4-21 2.5 GHz manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya, should
be less than the compliance level in each frequency
rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the AMX 4+ is used exceeds the
applicable RF compliance level above, the AMX 4+ should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the AMX 4+.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
Table 2-3 AMX 4+ Electromagnetic Immunity (Continued)

Table 2-4 Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and the AMX 4+
The AMX 4+ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the AMX 4+ can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the AMX 4+ as
recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Rated Maximum Output Power (P) 3,5 3,5 7
of Transmitter Watts (W) d=[ ] P d=[ ] P d =[ ] P
V1 E1 E1
Separation Distance Separation Distance Separation Distance
meters meters meters
0.01 (10 mW) 0.12 0.12 0.23
0.1 (100 mW) 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.7 23.33
For transmitters rated at a maximum output power not listed above, the separation distance can be estimated using
the equation in the corresponding column, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer. V1 and V2 are the COMPLIANCE LEVELS for the IEC 61000-
4-6 test and E1 is the COMPLIANCE LEVEL for the IEC 61000-4-3 test. V1 and V2 are in V and E1 is in V/m.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
Section 3.0 - Use Recommendations

This product complies with IEC 60601-1-2 Edition 2 (2001) EMC standard for medical devices and
with radio frequency emission requirements per CISPR11 Group1 Class A standard limits. The
AMX 4+ is predominantly intended for use in hospitals.
Do not use devices which intentionally transmit RF Signals (Cellular Phones, Transceivers, or
Radio Controlled Products) in the vicinity of this equipment as it may cause performance outside
the published specifications. Keep the power to these types of devices turned off when near this
equipment.
Adhering to the distance separation recommended in Table 2-4, between 150 kHz & 2.5 GHz, will
reduce disturbances recorded at the image level but may not eliminate all disturbances. However,
when installed and operated as specified herein, the system will maintain its essential performance
by continuing to safely acquire controlled radiological X-ray exposures in a mobile radiography
environment.
For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put 2.3 meters
apart from the AMX 4+ (in order to avoid image interference risks).
The use of accessories, transducers, and cables other than those specified may result in degraded
ELECTROMAGNETIC COMPATIBILITY of the AMX 4+.

The medical staff in charge of this equipment is required to instruct technicians, patients, and other
people who may be around this equipment to comply fully with the above equipment requirements.
Section 4.0 - Installation Recommendations

This system complies with above mentioned EMC standard when used with supplied cables.
In order to minimize interference risks, the following requirements shall apply.
4.1 Cable Shielding & Grounding

All interconnect cables to peripheral devices must be shielded and properly grounded. Use of
cables not properly shielded and grounded may result in the equipment causing radio frequency
interference.
4.2 Subsystem & Accessories Power Supply Distribution

All components, accessories subsystems, systems which are electrically connected to the AMX 4+,
must have all AC power supplied by the same power distribution panel & line.
4.3 Stacked Components & Equipment

The AMX 4+ should not be used adjacent to or stacked with other equipment; if adjacent or stacked
use is necessary, the AMX 4+ should be tested and verified in order to ensure normal operation in
the configuration in which it will be used. Consult qualified personnel regarding device/system
configurations.
4.4 Low Frequency Magnetic Field

Not applicable.
4.5 Static Magnetic Field Limits

In order to avoid interference on the AMX 4+ system, static field limits from the surrounding
environment are specified.
Static field is specified less than <1 Gauss around the unit.
4.6 Electrostatic Discharge Environment & Recommendations

In order to reduce electrostatic discharge interference, install a charge dissipative floor material to
avoid electrostatic charge buildup.
The relative humidity shall be at least 30 percent.
The dissipative material shall be connected to the system ground reference, if applicable.
Page 16 Section 4.0 - - Installation Recommendations

Chapter 3 - Precision 500D Product

3 test for Large, Permanently-Installed Equipment.
communications.
To provide reasonable protection against such interference, this product complies with the radiated
emission standard limits as per CISPR11 Group1 Class A standard limits.
separation distances in Table 3-4)
The Precision 500D is predominantly intended for use in non-domestic environments, and not
directly connected to the Public Mains Network that supplies buildings used for domestic purposes.
of the Precision 500D. Further detailed data & requirements are described in the Use
Recommendations and Installation Recommendations sections.
Chapter 3 - - Precision 500D Product Page 17


The Precision 500D is suitable to be used in an electromagnetic environment, as per the limits &
recommendations described in the tables hereafter:

The Precision 500D is intended for use in the electromagnetic environment specified below. The customer or the user of the
Precision 500D should assure that it is used in such an environment.
The Precision 500D uses RF energy only for its internal function.
RF emissions, CISPR 11 Group 1 Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The Precision 500D is predominantly intended for use in non-
domestic environments, and not directly connected to the Public
RF emissions, CISPR 11 Class A Mains Network. The Precision 500D is predominantly intended for
use (e.g. in hospitals) with a dedicated supply system, and in an X-
ray shielded room.
Harmonic emissions,
IEC 61000-3-2 Based on IEC 60601-1-2, IEC 61000-3-2 and IEC 61000-3-3 are not
Voltage fluctuations/ Not Applicable applicable because Precision 500 draws more than 16 Amps per
flicker emissions, phase.
IEC 61000-3-3
Table 3-1 Precision 500D Electromagnetic Emission


The Precision 500D is intended for use in the electromagnetic environment specified below. The customer or the user of the
Precision 500D should assure that it is used in such an environment.
Guidance
Floors should be wood, concrete, or
Electrostatic discharge +/− 6 kV contact. +/− 6 kV contact. ceramic tile. If floors are covered
(ESD), IEC 61000-4-2 +/− 8 kV air. +/− 8 kV air. with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/ +/− 2 kV for power supply lines. +/− 2 kV for power supply lines. Mains power quality should be that
of a typical commercial or hospital
burst, EC 61000-4-4 +/− 1 kV for input/output lines. +/− 1 kV for input/output lines. environment
Mains power quality should be that

+/− 1 kV line(s) to line(s). +/− 1 kV line(s) to line(s).
Surge, IEC 61000-4-5 of a typical commercial or hospital
+/− 2 kV line(s) to earth. +/− 2 kV line(s) to earth.
environment.
< 5% UTa, (> 95% dip in UT) for 0.5 Because the Precision 500D
Not Applicable system draws 16 Amps per phase,
cycle.
the only test required is to drop
40% UT, (60% dip in UT) for 5 each phase out for 5 seconds.
Not Applicable
Voltage dips, short cycles. Mains power quality should be that
interruptions and 70% UT, (30% dip in UT) for 25 of a typical commercial or hospital
voltage variations on Not Applicable environment. If the user of the
cycles.
power supply input Precision 500D requires continued
lines, IEC 61000-4-11 operation during power mains
< 5% UT, (> 95% dip in UT) for 5 < 5% UT, (> 95% dip in UT) for 5 interruptions, it is recommended
sec. sec. that the Precision 500D be powered
from an un-interruptible power
supply or a battery.
Power frequency magnetic fields
Power frequency (50/60 should be at levels characteristic of
Hz) magnetic field, 3 A/m 3 A/m a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
Table 3-2 Precision 500D Electromagnetic Immunity


Guidance and Manufacturer’s declaration - electromagnetic immunity. The Precision 500D is suitable for use in the specified
electromagnetic environment. The customer or the user of the Precision 500D should assure that it is used in an
electromagnetic environment as described below.
Test Level Level
should be used no closer to any part of the Precision
500D, including cables, than the recommended
separation distance calculated from the equation
appropriate for the frequency of the transmitter.
3,5
d=[ ] P
V1 150 KHz to 80 MHz
3,5
d=[ ] P
7
rangeb.
a
should be considered. If the measured field strength in the location in which the Precision 500D is used exceeds the
applicable RF compliance level above, the Precision 500D should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Precision
500D.
b
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
Table 3-3 Precision 500D Electromagnetic Immunity (Continued)

Recommended separation distances between portable and

mobile RF communications equipment and the Precision 500D
The Precision 500D is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Precision 500D can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Precision 500D as recommended below, according to
the maximum output power of the communications equipment.
Rated Maximum Output 3,5 3,5 7
Power (P) of Transmitter d=[ ] P d=[ ] P d =[ ] P
Watts (W) V1 E1 E1

0.01 (10 mW) 0.12 0.12 0.23
0.1 (100 mW) 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power rating
of the transmitter in watts (W) according to the transmitter manufacturer. V1 and V2 are the
COMPLIANCE LEVELS for the IEC 61000-4-6 test and E1 is the COMPLIANCE LEVEL for the IEC
61000-4-3 test. V1 and V2 are in V and E1 is in V/m.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

Precision 500D is predominantly intended for use in hospitals.
equipment.
including safe X-Ray acquisition and patient positioning, correct collimator FOV and I.I. MAG
changes, proper error reporting, and integrity of patient and image data.
apart from the Precision 500D (in order to avoid image interference risks).
ELECTROMAGNETIC COMPATIBILITY of the Precision 500D.

This system complies with above mentioned EMC standard when used with supplied cables up to
maximum lengths referenced in the Precision 500D Pre-Installation manual.

interference.

All components, accessories subsystems, systems which are electrically connected to the
Precision 500D, must have all AC power supplied by the same power distribution panel & line.

The Precision 500D should not be used adjacent to or stacked with other equipment; if adjacent or
stacked use is necessary, the Precision 500D should be tested and verified in order to ensure
normal operation in the configuration in which it will be used. Consult qualified personnel regarding
device/system configurations.

Not applicable.

In order to avoid interference on the Precision 500D system, static field limits from the surrounding
environment are specified.


Chapter 4 - Revolution XR/d & Definium 8000

Products

This equipment complies with IEC 60601-1-2 Edition 2 (2001-09) [for Revolution XR/d] and IEC
60601-1-2 Edition 2.1 (2004-11) [for Definium 8000] EMC standards for medical devices.
3 test for Large, Permanently-Installed Equipment.
communications.
To provide reasonable protection against such interference, this product complies with the radiated
emission standard limits as per CISPR11 Group1 Class A standard limits.
separation distances in Table 4-4)
The Revolution XR/d and Definium 8000 systems are predominantly intended for use in non-
domestic environments, and not directly connected to the Public Mains Network that supplies
buildings used for domestic purposes.
of the Revolution XR/d or Definium 8000 systems. Further detailed data & requirements are
described in the Use Recommendations and Installation Recommendations sections.
Chapter 4 - - Revolution XR/d & Definium 8000 Products Page 23


This equipment complies with IEC 60601-1-2 Edition 2 (2001-09) [for Revolution XR/d] and IEC
60601-1-2 Edition 2.1 (2004-11) [for Definium 8000] EMC standards for medical devices.
The Revolution XR/d and Definium 8000 systems are suitable to be used in an electromagnetic
environment, as per the limits & recommendations described in the tables hereafter:

The Revolution XR/d and Definium 8000 systems are intended for use in the electromagnetic environment specified below.
The customer or the user of the Revolution XR/d or Definium 8000 system should assure that it is used in such an
environment.
The Revolution XR/d and Definium 8000 systems use RF energy only
for their internal function. Therefore, their RF emissions are very low
RF emissions, CISPR 11 Group 1
and are not likely to cause any interference in nearby electronic
equipment.
The Revolution XR/d and Definium 8000 systems are predominantly
intended for use in non-domestic environments, and not directly
connected to the Public Mains Network. The Revolution XR/d and
RF emissions, CISPR 11 Class A
Definium 8000 systems are predominantly intended for use (e.g. in
hospitals) with a dedicated supply system, and in an X-ray shielded
room.
Harmonic emissions,
IEC 61000-3-2 Based on IEC 60601-1-2, IEC 61000-3-2 and IEC 61000-3-3 are not
Voltage fluctuations/ Not Applicable applicable because Revolution XR/d and Definium 8000 systems
flicker emissions, draw more than 16 Amps per phase.
IEC 61000-3-3
Table 4-1 Revolution XR/d and Definium 8000 Electromagnetic Emission


The Revolution XR/d and Definium 8000 systems are intended for use in the electromagnetic environment specified below.
The customer or the user of the Revolution XR/d or Definium 8000 systems should assure that it is used in such an
environment.
Guidance
Floors should be wood, concrete, or
Electrostatic discharge +/− 6 kV contact. +/− 6 kV contact. ceramic tile. If floors are covered
(ESD), IEC 61000-4-2 +/− 8 kV air. +/− 8 kV air. with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/ +/− 2 kV for power supply lines. +/− 2 kV for power supply lines. Mains power quality should be that
of a typical commercial or hospital
burst, EC 61000-4-4 +/− 1 kV for input/output lines. +/− 1 kV for input/output lines. environment
Mains power quality should be that

+/− 1 kV line(s) to line(s). +/− 1 kV line(s) to line(s).
Surge, IEC 61000-4-5 of a typical commercial or hospital
+/− 2 kV line(s) to earth. +/− 2 kV line(s) to earth. environment.
< 5% UTa, (> 95% dip in UT) for 0.5 Because the Revolution XR/d and
Not Applicable Definium 8000 systems draw 16
cycle.
Amps per phase, the only test
40% UT, (60% dip in UT) for 5 required is to drop each phase out
Not Applicable
cycles. for 5 seconds.
70% UT, (30% dip in UT) for 25 Mains power quality should be that
Voltage dips, short Not Applicable
cycles. of a typical commercial or hospital
interruptions and
environment. If the user of the
voltage variations on
Revolution XR/d or Definium 8000
power supply input
system requires continued
lines, IEC 61000-4-11
operation during power mains
< 5% UT, (> 95% dip in UT) for 5 < 5% UT, (> 95% dip in UT) for 5 interruptions, it is recommended
sec. sec. that the Revolution XR/d or
Definium 8000 be powered from an
un-interruptible power supply or a
battery.
Power frequency magnetic fields
Power frequency (50/60 should be at levels characteristic of
Hz) magnetic field, 3 A/m 3 A/m a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
Table 4-2 Revolution XR/d and Definium 8000 System Electromagnetic Immunity

Guidance and Manufacturer’s declaration - electromagnetic immunity. The Revolution XR/d or Definium 8000 system is
suitable for use in the specified electromagnetic environment. The customer or the user of the Revolution XR/d or Definium
8000 system should assure that it is used in an electromagnetic environment as described below.
Test Level Level
should be used no closer to any part of the Revolution
XR/d or Definium 8000 system, including cables, than
the recommended separation distance calculated from
the equation appropriate for the frequency of the
transmitter.
3,5
d=[ ] P
V1 150 KHz to 80 MHz
3,5
d=[ ] P
Conducted RF, 3 Vrms, 150 kHz V1 = 3Vrms 7
IEC 61000-4-6 to 80 MHz d =[ ] P
E1 800 MHz to 2.5 GHz
Radiated RF 3 V/m, 80 MHz to E1 = 3V/m where, P is the maximum output power rating of the
IEC 61000-4-21 2.5 GHz transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
rangeb.
Tested with RF transmitter, refer to:

Definium 8000:
• IEC 60601-1-2 Edition 2.1, 2004-11, 36.202.3.b.9
Radiated RF @ ISM 3 V/m 3 V/m
Frequencies • IEC 60601-1-2 Edition 2, 2001-09, 36.202.3.b.9
Table 4-3 Revolution XR/d and Definium 8000 Electromagnetic Immunity (Continued)

Guidance and Manufacturer’s declaration - electromagnetic immunity. The Revolution XR/d or Definium 8000 system is
suitable for use in the specified electromagnetic environment. The customer or the user of the Revolution XR/d or Definium
8000 system should assure that it is used in an electromagnetic environment as described below.
Test Level Level
a
should be considered. If the measured field strength in the location in which the Revolution XR/d or Definium 8000 is
used exceeds the applicable RF compliance level above, the Revolution XR/d or Definium 8000 should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the Revolution XR/d or Definium 8000.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than V1.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
Table 4-3 Revolution XR/d and Definium 8000 Electromagnetic Immunity (Continued)

Recommended separation distances between portable and

mobile RF communications equipment and the Revolution XR/d or Definium 8000 System
The Revolution XR/d or Definium 8000 system is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the Revolution XR/d or
Definium 8000 system can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Revolution XR/d or
Definium 8000 system as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum Output 3,5 3,5 7
Power (P) of Transmitter d=[ ] P d=[ ] P d =[ ] P
Watts (W) V1 E1 E1

0.01 (10 mW) 0.12 0.12 0.23
0.1 (100 mW) 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power rating
of the transmitter in watts (W) according to the transmitter manufacturer. V1 and V2 are the
COMPLIANCE LEVELS for the IEC 61000-4-6 test and E1 is the COMPLIANCE LEVEL for the IEC
61000-4-3 test. V1 and V2 are in V and E1 is in V/m.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.


Revolution XR/d or Definium 8000 system is predominantly intended for use in hospitals.
equipment.
including safe X-Ray acquisition and patient positioning, correct collimator FOV and I.I. MAG
changes, proper error reporting, and integrity of patient and image data.
apart from the Revolution XR/d or Definium 8000 system (in order to avoid image interference
risks).
ELECTROMAGNETIC COMPATIBILITY of the Revolution XR/d or Definium 8000 system.

This system complies with above mentioned EMC standard when used with supplied cables up to
maximum lengths referenced in the XR/d and Definium 8000 Pre-Installation manuals.

interference.

All components, accessories subsystems, systems which are electrically connected to the
Revolution XR/d or Definium 8000 system, must have all AC power supplied by the same power
distribution panel & line.

The Revolution XR/d or Definium 8000 system should not be used adjacent to or stacked with other
equipment; if adjacent or stacked use is necessary, the Revolution XR/d or Definium 8000 system
should be tested and verified in order to ensure normal operation in the configuration in which it will
be used. Consult qualified personnel regarding device/system configurations.

Not applicable.

In order to avoid interference on the Revolution XR/d or Definium 8000 system, static field limits
from the surrounding environment are specified.


Chapter 5 - Definium AMX 700 Product

This equipment complies with IEC 60601-1-2 Edition 2.1 (2004-11) EMC standard for medical
devices.
3 test method.
communications.
To provide reasonable protection against such interference, this product complies the radiated
emission as per CISPR11 Group1 Class A standard limits.
separation distances)
The Definium AMX 700 is intended for use in non-domestic environments, and not directly
connected to the Public Mains Network that supplies buildings used for domestic purposes.
The optional Dose Area Product (DAP) and other compatible accessories must be used within the
recommended operating conditions outlined in the operation manuals. In addition to calibration and
warm-up, the DAP and other devices must be reset before and after use to ensure accurate dose
measurements. Sustained exposure to electromagnetic fields (exceeding the test conditions) may
cause false measurements. Failure to follow the recommended use may cause false
measurements.
of the Definium AMX 700. Further detailed data & requirements are described in the Use
Recommendations and Installation Recommendations sections.

This equipment complies with IEC 60601-1-2 Edition 2.1 (2004-11) EMC standard for medical
devices.
Chapter 5 - - Definium AMX 700 Product Page 31

The Definium AMX 700 is suitable to be used in an electromagnetic environment, as per the limits
& recommendations described in the tables hereafter:

The Definium AMX 700 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Definium AMX 700 should assure that it is used in such an environment.
The Definium AMX 700 uses RF energy only for its
RF emissions, internal function. Therefore, its RF emissions are very
Group 1
CISPR 11 low and are not likely to cause any interference in nearby
electronic equipment.
RF emissions, The Definium AMX 700 is predominantly intended for
Class A
CISPR 11 use in non-domestic environments, and not directly
Harmonic connected to the Public Mains Network. The Definium
emissions, Class A AMX 700 is predominantly intended for use (e.g. in
IEC 61000-3-2 hospitals) with an appropriate power supply (see
operation manual) and the recommended shielding for
Voltage fluctuations/
portable use.
flicker emissions, Complies
IEC 61000-3-3
Table 5-1 Definium AMX 700 Electromagnetic Emission


The Definium AMX 700 is intended for use in the electromagnetic environment specified below. The customer or the
user of the Definium AMX 700 should assure that it is used in such an environment.
Guidance
Floors should be wood,
Electrostatic +/− 6 kV contact. +/− 6 kV contact. concrete, or ceramic tile. If floors
discharge (ESD), are covered with synthetic
IEC 61000-4-2 +/− 8 kV air. +/− 8 kV air. material, the relative humidity
should be at least 30%.
+/− 2 kV for power supply +/− 2 kV for power supply
Electrical fast lines. lines. Mains power quality should be
transient/burst, that of a typical commercial or
EC 61000-4-4 +/− 1 kV for input/output +/− 1 kV for input/output hospital environment
lines. lines.
+/− 1 kV line(s) to line(s). +/− 1 kV line(s) to line(s). Mains power quality should be
Surge, IEC 61000-4-5 that of a typical commercial or
+/− 2 kV line(s) to earth. +/− 2 kV line(s) to earth. hospital environment.
< 5% UTa, (> 95% dip in Mains power quality should be

< 5% UTa, (> 95% dip in
that of a typical commercial or
UT) for 0.5 cycle. UT) for 0.5 cycle.
Voltage dips, short hospital environment. If the user
interruptions and 40% UT, (60% dip in UT) 40% UT, (60% dip in UT) of the Definium AMX 700
voltage variations on for 5 cycles. for 5 cycles. requires continued operation
power supply input 70% UT, (30% dip in UT) 70% UT, (30% dip in UT) during power mains
lines, IEC 61000-4- interruptions, it is recommended
for 25 cycles. for 25 cycles.
11 that the Definium AMX 700 be
< 5% UT, (> 95% dip in UT) < 5% UT, (> 95% dip in UT) powered from an uninterruptible
for 5 sec. for 5 sec. power supply or a battery.
Power frequency magnetic
Power frequency (50/ fields should be at levels
60 Hz) magnetic 3 A/m 3 A/m characteristic of a typical
field, IEC 61000-4-8 location in a typical commercial
or hospital environment.
Table 5-2 Definium AMX 700 Electromagnetic Immunity


Guidance and Manufacturer’s declaration - electromagnetic immunity. The Definium AMX 700 is suitable for use in the
specified electromagnetic environment. The customer or the user of the Definium AMX 700 should assure that it is used in
an electromagnetic environment as described below.
Test Level Level
should be used no closer to any part of the Definium
AMX 700, including cables, than the recommended
separation distance calculated from the equation
appropriate for the frequency of the transmitter.
3,5
d=[ ] P
V1
3,5
d=[ ] P
7
rangeb.
a
should be considered. If the measured field strength in the location in which the Definium AMX 700 is used exceeds
the applicable RF compliance level above, the Definium AMX 700 should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
the Definium AMX 700.
b
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
Table 5-3 Definium AMX 700 Electromagnetic Immunity (Continued)

Recommended separation distances between portable and mobile RF communications equipment and the Definium
AMX 700
The Definium AMX 700 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Definium AMX 700 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
Definium AMX 700 as recommended below, according to the maximum output power of the communications
equipment.
Rated Maximum Output Power (P) 3,5 3,5 7
of Transmitter Watts (W) d=[ ] P d=[ ] P d =[ ] P
V1 E1 E1
0.01 (10 mW) 0.12 0.12 0.23
0.1 (100 mW) 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.7 23.33
For transmitters rated at a maximum output power not listed above, the separation distance can be estimated using
the equation in the corresponding column, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer. V1 and V2 are the COMPLIANCE LEVELS for the IEC 61000-
4-6 test and E1 is the COMPLIANCE LEVEL for the IEC 61000-4-3 test. V1 and V2 are in V and E1 is in V/m.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

Definium AMX 700 is predominantly intended for use in hospitals.
equipment.
by continuing to safely acquire controlled radiological X-ray exposures in a mobile radiography
environment.
apart from the Definium AMX 700 (in order to avoid image interference risks).

ELECTROMAGNETIC COMPATIBILITY of the Definium AMX 700.

This system complies with above mentioned EMC standard when used with supplied cables.

interference.

All components, accessories subsystems, systems which are electrically connected to the Definium
AMX 700, must have all AC power supplied by the same power distribution panel & line.

The Definium AMX 700 should not be used adjacent to or stacked with other equipment; if adjacent
or stacked use is necessary, the Definium AMX 700 should be tested and verified in order to ensure
normal operation in the configuration in which it will be used. Consult qualified personnel regarding
device/system configurations.

Not applicable.

In order to avoid interference on the Definium AMX 700 system, static field limits from the
surrounding environment are specified.


GE HEALTHCARE
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Technical Publication: Direction 5125914-100 Revision 7 GE Healthcare EMC Compliance Statement

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GE Healthcare

Copyright © 2004 by General Electric Company, Inc.

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• THIS SERVICE MANUAL IS AVAILABLE IN ENGLISH ONLY.

• CE MANUEL DE MAINTENANCE N’EST DISPONIBLE QU’EN ANGLAIS.

• DIESES KUNDENDIENST-HANDBUCH EXISTIERT NUR IN ENGLISCHER SPRACHE.

• ESTE MANUAL DE SERVICIO SÓLO EXISTE EN INGLÉS.

• ESTE MANUAL DE ASSISTÊNCIA TÉCNICA SÓ SE ENCONTRA DISPONÍVEL EM

• IL PRESENTE MANUALE DI MANUTENZIONE È DISPONIBILE SOLTANTO IN INGLESE.

Chapter 2 - AMX 4+ Product ................................................................................. 11

Chapter 3 - Precision 500D Product .................................................................... 17

Chapter 4 - Revolution XR/d & Definium 8000 Products ................................... 23

Table of Contents Page 7

Chapter 5 - Definium AMX 700 Product .............................................................. 31

Page 8 Table of Contents

Chapter 1 - - Introduction Page 9

THIS PAGE LEFT INTENTIONALLY BLANK

Chapter 2 - AMX 4+ Product

Section 1.0 - Compliance Statement

Section 2.0 - Compatibility Tables

Chapter 2 - - AMX 4+ Product Page 11

2.1 Electromagnetic Emission

Guidance and manufacturer’s declaration – Electromagnetic Emissions

Page 12 Section 2.0 - - Compatibility Tables

Guidance and Manufacturer’s declaration – electromagnetic immunity.

< 5% UTa, (> 95% dip in Mains power quality should be

Table 2-2 AMX 4+ Electromagnetic Immunity

Chapter 2 - - AMX 4+ Product Page 13

Page 14 Section 2.0 - - Compatibility Tables

Separation distance according to frequency of transmitter

0.01 (10 mW) 0.12 0.12 0.23

0.1 (100 mW) 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.7 23.33

Section 3.0 - Use Recommendations

Chapter 2 - - AMX 4+ Product Page 15

Section 4.0 - Installation Recommendations

4.1 Cable Shielding & Grounding

4.2 Subsystem & Accessories Power Supply Distribution

4.3 Stacked Components & Equipment

4.4 Low Frequency Magnetic Field

4.5 Static Magnetic Field Limits

4.6 Electrostatic Discharge Environment & Recommendations

Page 16 Section 4.0 - - Installation Recommendations

Chapter 3 - Precision 500D Product

Section 1.0 - Compliance Statement

Chapter 3 - - Precision 500D Product Page 17

Section 2.0 - Compatibility Tables

2.1 Electromagnetic Emission

Guidance and manufacturer’s declaration – Electromagnetic Emissions

Page 18 Section 2.0 - - Compatibility Tables

Guidance and Manufacturer’s declaration – electromagnetic immunity.

Mains power quality should be that

Table 3-2 Precision 500D Electromagnetic Immunity

Chapter 3 - - Precision 500D Product Page 19

Page 20 Section 2.0 - - Compatibility Tables