Sedecal HF Series Instruction Manual

SEDECAL
Technical Publication
OM-0279R1
Operation
HF Series Generators
RAD Console

This product bears a CE marking in accordance with the provisions of the 93/42/EEC MDD dated June 14, 1993.
Este producto ostenta una marca CE de acuerdo con las disposiciones de la Directiva 93/42/CEE del 14 de Junio de 1993 sobre Productos Médicos.
Ce produit porte la marque CE de conformité aux réglements de la Directive 93/42/CEE du 14 juin 1993 relative aux Produits médicaux.
Manufactured by:
Fabricado por:
SEDECAL
Sociedad Española de Electromedicina y Calidad S.A.
Pelaya, 9 -- 13. Polígono Industrial “Río de Janeiro”
28110 Algete, Madrid -- España (Spain)
Phone: [phone] Fax: [phone] www.sedecal.com
This manual covers the following equipments / Este manual cubre los siguientes equipos / Ce manuel couvre les équipements suivants
SHF--310, SHF--315, SHF--320, SHF--325, SHF--330, SHF--335
SHF--410, SHF--415, SHF--420, SHF--425, SHF--430, SHF--435
SHF--510, SHF--515, SHF--520, SHF--525, SHF--530, SHF--535
SHF--630, SHF--635, SHF--835

¡ IMPORTANTE ! ... Protección ante los rayos-X
LOS EQUIPOS DE RAYOS-X SON PELIGROSOS PARA EL PACIENTE Y EL OPERADOR
A MENOS QUE LAS MEDIDAS DE PROTECCION SEAN ESTRICTAMENTE OBSERVADAS
Si el equipo de rayos-X no se usa adecuadamente, puede causar lesiones. Por este motivo, las instrucciones
aquí incluidas se deben leer y comprender en su totalidad antes de intentar poner el equipo en funcionamiento.
Estaremos gustosos de asistir y cooperar en poner el equipo en marcha.
Aunque el equipo está construido según las normas de seguridad más estrictas y presenta un alto grado de protección contra las
radiaciones-X, ningún diseño practico puede ofrecer una protección completa. Tampoco ningún diseño practico puede obligar al operador
a tomar las precauciones adecuadas para prevenir la posibilidad de que cualquier persona de manera descuidada, poco sensata o
ignorante, se exponga a radiaciones directas o indirectas.
Es importante que cualquier persona relacionada con radiaciones-X esté debidamente entrenada y tome las medidas adecuadas para
asegurar la protección contra posibles lesiones.
El fabricante asume que todo operador y personal de servicio autorizado para manejar, instalar, calibrar o mantener este equipo, es
consciente del peligro que conlleva la exposición excesiva a las radiaciones-X, está suficientemente entrenado y posee los conocimiento
necesarios para ello. Por lo tanto, el equipo aquí descrito se vende entendiendo que el fabricante, sus agentes y representantes
no tienen ninguna responsabilidad en caso de lesiones o daños que puedan resultar de la exposición a dichas radiaciones.
Existen diversos materiales y dispositivos protectores, cuyo uso es recomendable.
IMPORTANT ! ... X-ray Protection
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR
UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED
X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein should be thoroughly
read and understood before attempting to place this equipment in operation. We will be glad to assist and
cooperate in placing this equipment in use.
Although this apparatus is built to the highest safety standards and incorporates a high degree of protection against X-radiation other
than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the
operator to take adequate precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves
or others to X-radiation.
It is important that everyone working with X-radiation be properly trained and take adequate steps to insure protection against injury.
The manufacturer assumes that all operator and service personnel authorized to use, install, calibrate and maintain this equipment
is cognizant of the danger of excessive exposure to X-radiation, is sufficiently trained and has the required knowledges for it. The
equipment herein described is sold with the understanding that the manufacturer, its agents, and representatives are not liable for
injury or damage which may result from exposure to X-radiation.
Various protective material and devices are available. It is recommended that such materials and devices be used.
IMPORTANT ! ... Protection contre les rayons-X
L’EQUIPEMENT RAYONS-X EST DANGEREUX A LA FOIS POUR LE PATIENT ET POUR L’OPERATEUR
A MOINS D’OBSERVER STRICTEMENT LES CONSIGNES DE PROTECTION
L’équipement à rayons-X peut provoquer des blessures s’il n’est pas correctement utilisé. En conséquence,
les instructions de ce manuel doivent être lues attentivement et bien assimilées avant de tenter de mettre en
route ce matériel. Nous serons heureux de vous assister et de coopérer à l’installation de ce matériel.
Bien que cet équipement soit construit selon les normes de construction les plus sévères et qu’il comporte un haut degré de protection
contre le rayonnement-X en dehors du rayon utile, aucune conception n’apporte une protection totale. De même qu’aucune conception
ne peut obliger l’opérateur à prendre les précautions adéquates afin d’éviter que toute personne ne s’expose ou n’expose les autres
au rayonnement sans précaution, de façon imprudente et inconsciente.
Il est important que toutes les personnes travaillant avec le rayonnement-X soit correctement formées et prennent les mesures adéquates
afin de se protéger contre toute blessure.
Le constructeur suppose que tous les utilisateurs et le personnel d’entretien autorisé à utiliser, installer, calibrer et entretenir cet équipement
est conscient du danger de l’exposition excessive au rayonnement-X, est suffisamment formé et possède les connaissances nécessaires
pour cela. L’équipement décrit dans le présent manuel est vendu sous réserve que le fabricant, ses agents et représentants ne soient
pas tenus pour responsables des blessures ou dommages qui pourraient résulter d’une exposition aux rayons-X.
Plusieurs matériels de protection et systèmes sont disponibles. L’utilisation de ces matériels et systèmes de protection est recommandée.

DECLARACION AMBIENTAL
SOBRE LA VIDA UTIL DEL EQUIPO O SISTEMA
Este equipo o sistema contiene componentes y materiales peligrosos para el medioambiente (tales
como tarjetas de circuito impreso, componentes electrónicos, aceite dieléctrico usado, plomo,
baterías, etc), los cuales se consideran y son residuos peligrosos al finalizar la vida útil del equipo o
sistema, según establecen las normas internacionales, nacionales y locales.
El fabricante recomienda que al finalizar la vida útil de equipo o sistema, se contacte con un
representante autorizado del fabricante o con un gestor autorizado de residuos para la retirada de este
equipo o sistema.
ENVIRONMENTAL STATEMENT
ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM
This equipment or system contains environmentally dangerous components and materials (such as
PCB‘s, electronic components, used dielectric oil, lead, batteries etc.) which, once the life-cycle of the
equipment or system comes to an end, becomes dangerous and need to be considered as harmful
waste according to the international, domestic and local regulations.
The manufacturer recommends to contact an authorized representative of the manufacturer or an
authorized waste management company once the life-cycle of the equipment or system comes to an
end to remove this equipment or system.
DECLARATION D’ENVIRONNEMENT
SUR LA VIE UTILE DE L’EQUIPEMENT OU SYSTEME
Cet équipement ou système contient des composants et matériaux dangereux pour l’environnement
(ex: électroniques cartes, composants électroniques, huile diélectrique usée, plomb, batteries, etc.),
lesquels sont considérés comme résidus dangereux en cycle terminal de vie d’un équipement ou
système, en accord avec les normes internationales, nationales et locales en vigueur.
Le fabricant recommande une fois le cycle terminal de l’équipement ou système atteint, de contacter
un représentant autorisé du fabricant ou les autorités compétentes en la matière afin d’organiser et
de gérer le recyclage adéquat de cet équipement ou appareil.

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REVISION HISTORY
REVISION DATE REASON FOR CHANGE
0MAY 18, 2004 First edition.
1SEP 27, 2010 Electromagnetic Compatibility (EMC)
This Document is the English original version, edited and supplied by the manufacturer.
The Revision state of this Document is indicated in the code number shown at the bottom of this page.
ADVISORY SYMBOLS
The following advisory symbols will be used throughout this manual. Their
application and meaning are described below.
DANGERS ADVISE OF CONDITIONS OR SITUATIONS THAT
IF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUS
PERSONAL INJURY OR DEATH.
ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT
HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL
INJURY, OR CATASTROPHIC DAMAGE OF EQUIPMENT OR
DATA.
Advise of conditions or situations that if not heeded or
avoided could cause personal injury or damage to equipment
or data.
Note .Alert readers to pertinent facts and conditions. Notes represent
information that is important to know but which do not necessarily
relate to possible injury or damage to equipment.

HF Series Generators -- RAD Console
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OM-0279R1
SAFETY SYMBOLS
The following safety symbols will be used in the equipment.
Their meaning are described below.
Attention, consult accompanying documents.
Ionizing radiation.
Type B equipment.
Dangerous voltage.
Ground.
This symbol indicates that the waste of electrical and
electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer or
an authorized waste management company for information
concerning the decommissioning of your equipment.

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TABLE OF CONTENTS
Section Page
1 INTRODUCTION 1.........................................................
1.1 General Features 2..................................................
1.2 Options 3...........................................................
1.3 Product Identification 3...............................................
1.4 Certifications 4......................................................
1.5 Classification 4.......................................................
2SAFETY 5................................................................
2.1 General 5...........................................................
2.2 Responsibilities 6.....................................................
2.3 Máximum Permissible Dose (MPD) 7...................................
2.4 Radiation Protection 7.................................................
2.5 Monitoring of Personnel 8.............................................
2.6 Protection against Electric Shock Hazards 8.............................
2.7 Electromagnetic Compatibility (EMC) 9..................................
3 OPERATING CONTROLS 15................................................
3.1 Radiography and General Controls 16...................................
3.1.1 Power ON / OFF 16............................................
3.1.2 Workstations Selection 16......................................
3.1.3 Focal Spot Indicators 17........................................
3.1.4 Radiographic Parameters 18.....................................
3.2 Automatic Exposure Control (AEC) 20....................................
3.3 Anatomical Programmer (APR) 21.......................................
3.4 Exposure Controls and Indicators 28.....................................
3.5 X-ray Handswitch 28..................................................

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Section Page
3.6 Heat Units 29.........................................................
3.7 Exposure Counters 29.................................................
3.8 Self-Diagnosis Indicators 30............................................
3.9 Error Codes 31........................................................
4 OPERATING SEQUENCES 35...............................................
4.1 Start-up Routine 35...................................................
4.2 X-Ray Tube Warm-up Procedure 35.....................................
4.3 Radiographic Operation 36.............................................
4.4 AEC Operation 37.....................................................
4.5 APR Operation 38.....................................................
5 PERIODIC MAINTENANCE 39...............................................
5.1 Operator Tasks 39.....................................................
5.2 Service Tasks 40......................................................
6 TECHNICAL SPECIFICATIONS 41...........................................
6.1 Factors 41...........................................................
6.2 Range of Radiographic Parameters 42...................................
6.3 Duty Cycle 42.........................................................
6.4 Physical Characteristics 42.............................................

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SECTION 1 INTRODUCTION
This manual contains all the information necessary to understand and operate
the High Frequency Generators with the RAD Console. It provides a general
description, safety and regulatory information, operating instructions and
specifications concerning the equipment.
This high frequency X-ray Generator is designed for general radiography. It
provides all the advantages of high frequency waveform Generators including
lower patient dose, shorter exposure times and greater accuracy and
consistency.
The Generator is controlled by multiple microprocessors providing increased
exposure consistency, efficient operation and extended Tube life. A high level
of self-diagnosis greatly increases serviceability and reduces down time.
All functions, displays and controls are logically arranged, easily accessible
and identified to prevent confusion. Technique factors and functions are
selected by touch sensitive push-buttons and displayed on the Control Console.
Illustration 1-1
RAD Console

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Operation
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The Generator consists of the following essential parts:
•Control Console, operator controls and displays for radiographic
operations. The Console is designed for ease of operation. It is the
interface with the Power Cabinet and other related X-ray systems.
•Power Cabinet, that comprises:
GPower Module, which contains the power and control
components.
GHigh Voltage Transformer.
1.1 GENERAL FEATURES
The main features of this high frequency Generator are:
•Constant potential high frequency, operating on three phase and single
phase lines.
•Three point control by selecting kVp, mA and Exposure time, or two point
control by selecting kVp and mAs, or one point control by selecting kVp
with AEC operations.
•Two Buckys can be directly connected to the Generator (standard).
•Self-diagnosis indicators identify malfunctions in the system.
•Tube protection circuitry prolongs Tube life and increases system
performance.
•Equipped with closed loop control of X-ray Tube current, kVp and
filaments, which minimize potential errors and the need for
readjustments.
•Automatic line voltage compensation due to closed loop operation of
X-ray Tube current and kVp.
•Independent Heat Unit storage for each X-ray Tube, even after turning
On / Off the equipment.

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1.2 OPTIONS
In addition to the features described above, the Generator can be configured
with the following options:
•Anatomical Programmer (APR) for six patient sizes (three adults and
three children), with pre-programmed anatomical views for automatic
selection. The operator may introduce modifications manually in all the
original APR techniques and store them for later use.
•Automatic Exposure Control (AEC), which accommodates most popular
exposure detectors. A total of up to four detectors (Ionization or Solid
State types) can be installed on the system. Each one can be
independently calibrated.
•Third / Fourth Bucky, this option allows to connect of up to four Buckys
to the Generator.
•Tomography, an adaptation to interface with the Tomo device.
•Second X-ray Tube, which extends the system for using two X-ray
Tubes.
•High Speed Rotor Controller, an optional digital controller consisting of
a module which is fitted within the Power Cabinet.
1.3 PRODUCT IDENTIFICATION
The major items in the Generator have some identification labels attached to
them which provide the following manufacturer and product information.
•Product.
•Model.
•Volts (V), Line Phases, Frequency (Hz), and Power (kVA, kW).
•Date of manufacture.
•Serial number.
•Reference.
•Manufacturer.
•Place of manufacture
•Certification.

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1.4 CERTIFICATIONS
The X-ray Unit covered by this Operation Manual is authorized to be marked
with CE MARKING in accordance with the provisions of the Council Directive
93 / 42 / EEC concerning Medical Devices.
1.5 CLASSIFICATION
The X-ray Generator covered by this Operation Manual is classified as:
•Protection against Electric Shock: Class I -- Type B applied parts.
•Protection against Harmful Ingress of Water: Ordinary.
•Degree of Safety in the presence of Flammable Anesthetics Mixture with
air or with oxygen or with nitrous oxide: Not suitable for use in the
presence of Flammable Anesthetics Mixture with air or with oxygen or
with nitrous oxide.
•Mode of Operation: Continuous operation with intermittent loading.
•Permanently Installed Equipment.

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SECTION 2 SAFETY
2.1 GENERAL
Keep this Operating Manual with the equipment at all times and periodically
review the Operating and Safety instructions.
For continue safe use of this equipment follow the
instructions in this Operating Manual. Study this manual
carefully before using the equipment and keep it at hand for
quick reference.
THE EQUIPMENT DESCRIBED IN THIS MANUAL MUST BE
ONLY HANDLE BY QUALIFIED PERSONNEL PREVIOUSLY
TRAINED IN IT.
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND
OPERATOR UNLESS PROTECTION MEASURES ARE
STRICTLY OBSERVED.
IT IS VITALLY IMPORTANT THAT EVERYONE ASSOCIATED
WITH X-RAY RADIATION IS FAMILIAR WITH THE SAFETY
AND REGULATORY INSTRUCTIONS CONTAINED WITHIN
THIS MANUAL, IN PARTICULAR, THE STATEMENT AT THE
BEGINNING OF THIS MANUAL ENTITLED “IMPORTANT!...
X-RAY PROTECTION”.
THESE INSTRUCTIONS SHOULD BE THOROUGHLY READ
AND UNDERSTOOD BEFORE ATTEMPTING TO PLACE THIS
EQUIPMENT IN OPERATION.
Although X-radiation can be hazardous, X-ray equipment does not pose any
danger when it is properly used. Please ensure that all service and operating
personnel are properly trained and informed on the hazards of radiation. Those
responsible for the system must understand the safety requirements for X-ray
operation. Please study this manual and the manuals for each system
component to be fully aware of all the safety and operational requirements.

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2.2 RESPONSIBILITIES
ENSURE THAT ALL PERSONNEL AUTHORIZED TO USE THE
EQUIPMENT ARE AWARE OF THE DANGER OF EXCESSIVE
EXPOSURE TO X-RAY RADIATION.
THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THE
UNDERSTANDINGTHEMANUFACTURER,ITS AGENTS, AND
REPRESENTATIVES ARE NOT LIABLE FOR INJURY OR
DAMAGE WHICH MAY RESULT FROM OVEREXPOSURE OF
PATIENTS OR PERSONNEL TO X-RAY RADIATION.
THE MANUFACTURER DOES NOT ACCEPT ANY
RESPONSIBILITY FOR OVEREXPOSURE OF PATIENTS OR
PERSONNEL TO X-RAY RADIATION GENERATED BY THIS
EQUIPMENT WHICH IS A RESULT OF POOR OPERATING
TECHNIQUES OR PROCEDURES.
NO RESPONSIBILITY WILL BE ASSUMED FOR ANY
EQUIPMENT THAT HAS NOT BEEN SERVICED AND
MAINTAINED IN ACCORDANCE WITH THE MANUFACTURER
INSTRUCTIONS, OR WHICH HAS BEEN MODIFIED OR
TAMPERED WITH IN ANY WAY.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE
THE SAFETY OF THE PATIENT WHILE THE X-RAY
EQUIPMENT IS IN OPERATION BY VISUAL OBSERVATION,
PROPER PATIENT POSITIONING, AND USE OF THE DEVICES
THAT ARE INTENDED TO PREVENT PATIENT INJURY.
ALWAYS WATCH ALL PARTS OF THE SYSTEM TO VERIFY
THAT THERE IS NO INTERFERENCE AND NO POSSIBILITY
OF COLLISION WITH THE PATIENT OR WITH OTHER
EQUIPMENTS.
SHOULD ANY INTERFERENCE (EMC) BE DETECTED WITH
OTHER EQUIPMENT, PLEASE POSITION OTHER
EQUIPMENT AWAY FROM THIS ONE.

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2.3 MAXIMUM PERMISSIBLE DOSE (MPD)
Before operation, persons qualified and authorized to operate this equipment
should be familiar with the Recommendations of the International Commission
on Radiological Protection, contained in Annals Number 60 of the ICRP, with
applicable National Standards, and should have been trained in use of the
equipment.
THE OPERATOR SHALL USE THE LARGEST POSSIBLE
FOCAL SPOT TO SKIN DISTANCE IN ORDER TO KEEP THE
ABSORBED DOSE AS LOW AS REASONABLY ACHIEVABLE.
2.4 RADIATION PROTECTION
Because exposure to X-ray radiation may be damaging to health, use greatcare
to provide protection against exposure to the primary beam. Some of the effects
of X-ray radiation are cumulative and may extend over a period of months or
years. The best safety rule for X-ray operator is “Avoid exposure to the primary
beam at all times”.
Any object in the path of the primary beam produces secondary (scattered)
radiation. The intensity of the secondary radiation is dependent upon the
energy and intensity of the primary beam and the atomic number for the object
material struck by the primary beam. Secondary radiation may be of greater
intensity than that of the radiation reaching the film. Take protective measures
to safeguard against it.
An effective protective measure is the use of lead shielding. To minimize
dangerous exposure, use such items as lead screens, lead impregnated
gloves, aprons, thyroid collars, etc. The lead screen should contain a minimum
of 2.0 mm of lead or equivalent and personal protective devices (aprons,
gloves, etc.) must contain a minimum of 0.25 mm of lead or equivalent. For
confirmation of the local requirements at your site, please refer to your “Local
Radiation Protection Rules” as provided by your Radiation Protection Advisor.
WHILE OPERATING OR SERVICING X-RAY EQUIPMENT,
ALWAYS KEEP A DISTANCE NOT LESS THAN 2 METERS
FROM THE FOCAL SPOT AND X-RAY BEAM, PROTECT
BODY AND DO NOT EXPOSE HANDS, WRISTS, ARMS OR
OTHER PARTS OF THE BODY TO THE PRIMARY BEAM.

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2.5 MONITORING OF PERSONNEL
Monitoring of personnel to determine the amount ofradiation to which they have
been exposed provides a valuable cross check to determine whether or not
safety measures are adequate. It may reveal inadequate or improper radiation
protection practices and potentially serious radiation exposure situations.
The most effective method of determining whether or not the existing protective
measures are adequate is the use of instruments to measure the exposure.
These measurements should be taken at all locations where the operator, or
any portion of the body may be exposed. Exposure must never exceed the
accepted tolerable dose.
A frequently used, but less accurate, method of determining the amount of
exposure is the placement of film at strategic locations. After a specified period
of time, develop the film to determine the amount of radiation.
A common method of determining whether personnel have been exposed to
excessive radiation is the use of personal radiation dosimeters. These consist
of X-ray sensitive film or thermoluminescent material enclosed within a holder
that may be worn on the body. Even though this device only measures the
radiation which reaches the area of the body on which they are worn, they do
provide a reasonable indication of the amount of radiation received.
2.6 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
This X-ray Unit has been classified type-B ( ) in accordance with IEC 60601-1.
This equipment meet the following Safety Standards: IEC 60601-1,
IEC 60601-2-7.
ACCORDING TO MDD/93/42/CEE, THIS UNIT IS EQUIPPED
WITH EMC FILTERS. THE LACK OF THE PROPER
GROUNDING MAY PRODUCE ELECTRICAL SHOCK TO THE
USER.

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2.7 ELECTROMAGNETIC COMPATIBILITY (EMC)
This equipment generates, uses, and can radiate radio frequency energy. The
equipment may cause radio frequency interference to other medical or non
medical devices and radio communications. To provide reasonable protection
against such interference, this product complies with emissions limits for a
Group 1, class A Medical Devices Directive as stated in EN 60601--1--2.
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 operator (or qualified service personnel)
should attempt to correct the problem by one or more ofthe following measures:
•reorient or relocate the affected device,
•increase the separation between the equipment and the affected device,
•power the equipment from a source different from that of the affected
device,
•consult the service engineers for further suggestions.
To comply with the regulations on electromagnetic interference for a Class A
FCC Device, this equipment must be used in shielded areas and 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 in violation of the FCC
regulations.
Before using this equipment make sure that all requirements
about EMC included in this manual are accomplished.
It is customer responsibility to assure that this equipment
and vicinity equipment complies the value of radio frequency
interferences shown in General Regulation for safety
according to IEC 60601- 1- 2 Tables as described in this
section.

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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 type devices turned off when near this
equipment. Is the responsibility of the operator to instruct
patients and other people who may be around this equipment
to fully comply with the above requirement.
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.
GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC EMISSIONS
This X--Ray Generator is intended for use in the electromagnetic environment specified below.
The customer or the user of this X--Ray Generator should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -- guidance
RF emissions
CISPR 11 Group 1
This X--Ray Generator uses RF energy only for
its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11 Class A
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GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY
This X--Ray Generator is intended for use in the electromagnetic environment specified below.
The customer or the user of this X--Ray Generator should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level Electromagnetic environment -- guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
¦6kV contact
¦8kV air
¦6kV
¦8kV
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic material,
the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
¦2kV for power supply lines
¦1kV for input/output lines
¦2kV
¦0.5kV
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000--4--5
¦1kV line(s) to line(s)
¦2kV line(s) to earth
¦1kV
¦2kV
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines.
IEC 61000--4--11
<5%U
T
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5%U
T
(>95% dip in UT)
for 5s
>95%
during10ms
60%
during 100 ms
30%
during 500 ms
>95%
during 5000 ms
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the X--Ray Generator requires continued
operation during power mains interruptions, it is
recommended that the X--Ray Generator be
powered from an uninterruptible power supply
or a battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000--4--8
3A/m 3A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE -- UTis the a.c. mains voltage prior to application of the test level.

HF Series Generators -- RAD Console
Operation
OM-0279R1
12
GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY
This X--Ray Generator is intended for use in the electromagnetic environment specified below.
The customer or the user of this X--Ray Generator should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -- guidance
Conducted RF
IEC 61000--4--6
Radiated RF
IEC 61000--4--3
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2.5GHz
3Vrms
150kHz to 80MHz
3V/m
1 GHz to ..5GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of this Mobile Unit, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
where ’P’ is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and ’d’ is the
recommended separation distance in meters
(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:
d=1.2 P

d=2.3 P
, 800 MHz to 2.5 GHz
d=3.5∕E1P
, 80 MHz to 800 MHz
NOTE 1 -- At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 -- These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Note: In the 3rd equation of the 4th column, the constant parameter has a value of 2.3 for frequencies between 1 GHz and 2.5 GHz.
No information is given for frequencies between 80 MHz and 1 GHz.
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 this X--Ray Generator is used exceeds the applicable RF compliance level above, this X--Ray Generator should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re--orienting
or relocating this X--Ray Generator.
b) Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.