Technical Publication

OM-0527R5_EN_STX

Operation
SP4S
Standard & Auto-tracking
Ceiling Suspension
This product bears a CE marking in accordance with the provisions of the 93/42/EEC MDD dated June 14, 1993, as amended by 2007/47/EC dated September 5, 2007.

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, modificada por la directiva 2007/47/CE del 5 de septiembre de 2007.

Ce produit porte la marque CE de conformité aux réglements de la Directive 93/42/CEE du 14 juin 1993 relative aux Produits médicaux, modifiée par la directive 2007/47/CE du 5 septembre 2007.

The information comprised in this manual applies to the following equipments

La información contenida en este manual se aplica a los siguientes equipos
L’information contenue dans ce manuel est appliquée aux équipements suivants

Ceiling Tubestand SP4S:

SP4S (option ST) and SP4S (option AT)

Manufactured by:
Fabricado por:
Fabriqué par:

STEPHANIX
10 Rue Jean Moulin
Zone Industrielle du Bayon
42150 La Ricamarie
FRANCE
Tel. : 00 33 4 77 47 81 60 ; Fax : 00 33 4 77 37 55 19
 Standard and Auto-tracking Ceiling Suspension
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REVISION HISTORY

REVISION DATE REASON FOR CHANGE

0 JUL 05, 2011 First edition

1 OCT 05, 2012 IEC Standards Update
2 JUL 24, 2013 Collimators Update
3 FEB 29, 2016 General Updates
4 JUN 01, 2017 Labeling Update
5 JAN 25, 2018 IEC Standards Update

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.

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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.

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TABLE OF CONTENTS

Section Page

1 INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 General Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.2 Product Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.3.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.2 Normal Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4 Applied Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 SAFETY AND REGULATORY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.2 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.3 Maximum Permissible Dose (MPD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.4 Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.5 Monitoring of Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.6 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.7 Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.7.1 Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.7.2 Environmental Statement on the Life Cycle of the Equipment or
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.7.3 Mode of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.7.4 Protection against Electric Shock Hazards . . . . . . . . . . . . . . . . . . . . . . . 18
2.7.5 Protection against Harmful Ingress of Water or Particulate Matter . . . 18
2.7.6 Protection against hazards of Ignition of Flammable Anaesthetic
Mixtures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.7.7 Protection against Hazards from Unwanted or Excessive Radiation . 19
2.7.8 Designated Significant Zones of Occupancy . . . . . . . . . . . . . . . . . . . . . 19
2.8 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.9 Quantitative information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

2.9.1 Functional Tests performed to obtain the Quantitative Information . . . 28

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Section Page

2.10 Deterministic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

3 OPERATING SEQUENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.1 Power ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.2 X-ray Tube Warm-Up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.3 Radiographic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4 OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.1 Components of the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.2 Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.2.1 Manual Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.2.2 Detent Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.2.3 Auto-tracking Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.2.3.1 Operation with Elevating tTbles . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.2.3.2 Operation with Wall Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.3 RSA Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

5 COLLIMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.1 Ralco Automatic Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.2 Ralco Manual Collimator R225/R225 DHHS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

5.3 Dosimeter Device (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.4 X-ray Beam Alignment with Respect to Patient . . . . . . . . . . . . . . . . . . . . . . . . . . 55

6 TROUBLESHOOTING GUIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

7 PERIODIC MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

7.1 Operator Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

7.2 Service Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

8 TECHNICAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

APPENDIX A -- GUIDELINES FOR PEDIATRIC APPLICATIONS . . . . . . . . . . . . . . . . . . . . A-1

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SECTION 1 INTRODUCTION

This Positioner has been designed for general radiography in hospitals, clinics
and medical practices to make process and provide X-ray radiographic images
of the skeleton, skull, chest, abdomen, extremities and other body parts on the
patients. Images can be obtained with the patient in the sitting, standing or lying
position. This unit is not intended for mammography applications.

This manual contains all the necessary information to understand and operate
the Ceiling Suspension. It provides a general description, safety information,
operating instructions and specifications concerning the Standard and
Auto-tracking models of the equipment. It is not intended to teach radiology
or to make any type of clinical diagnosis.

This equipment is a heavy duty X-ray Tube Overhead Support system

characterized by its simple and functional design. Thanks to its vertical and
horizontal displacements, the suspension can cover almost all the room in
which it is installed. It can operate with a table, Wall Stand or R/F table
Bucky/Detector allowing all radiographic and fluoroscopic procedures. With its
new lightweight design, the system guarantees highly precise positioning for
optimal radiographic results. The new support system can operate on an
horizontal or vertical Bucky/Detector, or be installed with an elevating table.

The Ceiling Suspension basically consists of a Control Console and the X-ray
Tube and Collimator subassemblies. There are two different models available
depending on the system configuration:

G Standard Ceiling Suspension with the analog Control Console

and fully manually moved.

G Auto-tracking Ceiling Suspension with the analog Control

Console and the Vertical Axis motorized to allow the Auto-tracking
function.

Illustration 1-1
X-ray System with Manual / Auto-tracking Ceiling Suspension

Ceiling Suspension

Wall Stand
X-ray Elevating Table

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1.1 GENERAL FEATURES

The main features of the Ceiling Suspension are:

 Ergonomic, robust and light weight design, to withstand intensive

hospital use.

 Controls for lock release of the equipment.

 The Control Console of the Ceiling Suspension is ergonomically built,

equipped with controls logically arranged and easily accessible in every
angle and position of the X-ray Tube and Collimator assembly.

 Light weight Telescopic Column design with four independent parts

guided by a high precision alignment mechanism for a smooth and quiet
operation. This rigid and durable design reduces instability and vibration
to the minimum, to facilitate precision in positioning.

 Optimal mechanical balancing system for manual movements with

almost no efforts.

 X-ray Support with 360o for X-ray Tube rotation and 270o for X-ray Tube
angulation.

 Provided with analog Control Console, which indicates the SID and X-ray
Tube angulation (ANG).

 This equipment is compatible with a high range of Cassette/Detector

Trays (max. 430x430 mm).

 On Alpha and Beta Axis the Tube and Collimator are rotated around the
vertical (Alpha) or horizontal (Beta) axis of the Tube and Collimator
Assembly. Both movements are manually controlled, press and hold the
corresponding Control Console Brake Button also to rotated the Tube.

 Vertical movement is motorized assisted, it means that it is helped by the

Vertical Motor as soon as the user initiates the motion after releasing the
Brake and moves up/down the Tube and Collimator Assembly.

Beside the mentioned features, the difference between both models is that the
Standard Ceiling Suspension is not provided with the Auto-tracking function.
This function is activated and controlled by means the Control Console which
is provided with one or two Auto-tracking ON/OFF Buttons.

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1.2 PRODUCT IDENTIFICATION

The major items in the equipment have some identification labels attached to
them which provide the following manufacturer and product information.

 Product.

 Model.

 Date of manufacture.

 Serial number.

 Volts (V), Frequency (Hz), and Power (kVA).

 Manufacturer.

 Place of manufacture.

 Certification.

Illustration 1-2
Ceiling Suspension Labeling

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1.3 INDICATIONS FOR USE

1.3.1 INTENDED USE

This equipment is intended for use by qualified personnel only.

The Ceiling Suspension is an equipment included in a Medical Equipment

System designed for general radiography in hospitals, clinics and medical
practices to provide X-ray radiographic images of the skeleton, skull, chest,
abdomen, extremities and other body parts.

Images can be obtained with the patient in the sitting, standing or lying position.
Examinations can be performed to any kind of patient group. Patients may be
physically able, disable, immobilized or in a state of shock.

1.3.2 NORMAL USE

The Normal Use of this equipment is defined as the Intended Use plus the
Maintenance and Service tasks.

1.3.3 CONTRAINDICATIONS

Do not use the equipment for any purposes other than those for which it is
intended. Operation of the equipment for unintended purposes could lead to
fatal or other serious injury.

This equipment is not intended for mammography applications.

This equipment is not especifically designed for paediatric purposes; if children

are to be examined, they should always be accompanied by an adult.

1.4 APPLIED PARTS

Applied Parts refer to parts of ME Equipment that in Normal Use necessarily

comes into physical contact with the patient for ME Equipment to perform its
function. This RAD equipment does not include any Applied Parts.

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SECTION 2 SAFETY AND REGULATORY INFORMATION

This section describes the safety considerations, general precautions for

patient, operator and equipment in order to perform a safe operation and
service tasks.

Regulatory and symbols used in the equipment are detailed in this section to
operate it safely.

2.1 GENERAL

FOR CONTINUE SAFE USE OF THIS EQUIPMENT FOLLOW

THE INSTRUCTIONS IN THIS OPERATING MANUAL. BOTH
OPERATOR AND SERVICE PERSONNEL HAVE TO STUDY
THIS MANUAL CAREFULLY, INSTRUCTIONS HEREIN
SHOULD BE THOROUGHLY READ AND UNDERSTOOD
BEFORE ATTEMPTING TO PLACE THE EQUIPMENT IN
OPERATION, ESPECIALLY THE INSTRUCTIONS
CONCERNING SAFETY, REGULATORY, DOSAGE AND
RADIATION PROTECTION. KEEP THIS OPERATING MANUAL
WITH THE EQUIPMENT AT ALL TIMES AND PERIODICALLY
REVIEW THE OPERATING AND SAFETY INSTRUCTIONS.

TECHNICAL INSTRUCTIONS FOR SERVICE PERSONNEL

SUCH AS PRE-INSTALLATION REQUIREMENTS,
INSTALLATION, CALIBRATION OR MAINTENANCE ARE
DESCRIBED IN THE RESPECTIVE CHAPTERS OF THE
PRE-INSTALLATION AND SERVICE MANUALS PROVIDED
WITH THIS EQUIPMENT.

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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OPERATOR AND SERVICE PERSONNEL AUTHORIZED TO

USE, INSTALL, CALIBRATE AND MAINTAIN THIS
EQUIPMENT MUST BE AWARE OF THE DANGER OF
EXCESSIVE EXPOSURE TO X-RAY RADIATION. IT IS
VITALLY IMPORTANT THAT EVERYONE WORKING WITH
X-RAY RADIATION IS PROPERLY TRAINED, INFORMED ON
THE HAZARDS OF RADIATION AND TAKE ADEQUATE
STEPS TO ENSURE PROTECTION AGAINST INJURY.

OPERATOR MUST HAVE SUFFICIENT KNOWLEDGE TO

COMPETENTLY PERFORM THE DIFFERENT DIAGNOSTIC
IMAGING PROCEDURES WITH X-RAY DEVICES. THIS
KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF
EDUCATIONAL METHODS INCLUDING CLINICAL WORKING
EXPERIENCE, AND AS PART OF MANY COLLEGE AND
UNIVERSITY RADIOLOGIC TECHNOLOGY PROGRAMS IN
ACCORDANCE WITH LOCAL LAWS OR REGULATIONS.

SERVICE PERSONNEL MUST HAVE SUFFICIENT

KNOWLEDGE TO COMPETENTLY PERFORM THE SERVICE
TASKS RELATED TO X-RAY DEVICES AND PARTICULARLY
TO THE EQUIPMENT DESCRIBED IN THIS MANUAL. THIS
KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF
EDUCATIONAL METHODS FOR TECHNICIANS IN
ACCORDANCE WITH LOCAL LAWS OR REGULATIONS,
INCLUDING SPECIFIC TRAINING ON THIS EQUIPMENT.

X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND

OPERATOR UNLESS PROTECTION MEASURES ARE
STRICTLY OBSERVED. IF THE EQUIPMENT IS NOT
ACCURATELY USED, IT MAY CAUSE INJURY.

ALTHOUGH X-RADIATION CAN BE HAZARDOUS, X-RAY

EQUIPMENT DOES NOT POSE ANY DANGER WHEN IT IS
PROPERLY USED.

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SPECIAL ATTENTION MUST BE GIVEN TO DIAGNOSTIC

X-RAY EQUIPMENT SPECIFIED TO BE USED IN
COMBINATION WITH ACCESSORIES OR OTHER ITEMS. BE
AWARE OF POSSIBLE ADVERSE EFFECT ARISING FROM
THESE MATERIALS LOCATED IN THE X--RAY BEAM. (SEE
THE TABLE BELOW FOR THE MAXIMUM EQUIVALENT
ATTENUATION OF MATERIALS POSSIBLY LOCATED IN THE
X-RAY BEAM).

MAXIMUM ATTENUATION EQUIVALENT mm AL

ITEM IEC 60601-2-54:2009

21 CFR AND
IEC 60601-2-54:2009/AMD1:2015

Total of all layers composing the front panel of cassette holder 1.2 1.2

Total of all layers composing the front panel of FILM CHANGER 1.2 1.2

Total of all layers, excluding detector itself, composing the front

1.2 1.2
panel of DIGITAL X-RAY IMAGING DEVICE

Cradle 2.3 2.3

PATIENT SUPPORT, stationary, without articulated joints 1.2 1.2

PATIENT SUPPORT, movable, without articulated joints (including

1.7 1.7
stationary layers)

PATIENT SUPPORT, with radiolucent panel having one articulated

1.7 1.7
joint

PATIENT SUPPORT, with radiolucent panel having two or more

2.3 2.3
articulated joints

PATIENT SUPPORT, cantilevered 2.3 2.3

Note 1.-- Devices such as RADIATION DETECTORS are not included in the item listed in this table.

Note 2.-- Requirements concerning the ATTENUATION properties of RADIOGRAPHIC CASSETTES and of INTENSIFYING
SCREENS are given in ISO 4090 [3], for ANTI--SCATTER GRIDS in IEC 60627[1].

Note 3.-- ATTENUATION caused by table mattresses and similar accessories is not included in the maximum ATTENUATION
EQUIVALENT for PATIENT SUPPORT.

Note 4.-- Maximum ATTENUATION EQUIVALENT mm Al is only applied to the corresponding item. If several items given in this table
are located in the path of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR, each corresponding maximum
ATTENUATION EQUIVALENT mm Al is separately applied to each item.

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2.2 RESPONSIBILITIES

THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND

OPERATOR UNLESS SAFE EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND MAINTENANCE
SCHEDULES ARE OBSERVED.

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
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 NEITHER INTERFERENCE NOR
POSSIBILITY OF COLLISION WITH THE PATIENT OR WITH
OTHER EQUIPMENTS.

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IT IS THE RESPONSIBILITY OF THE PURCHASER/

CUSTOMER TO PROVIDE THE MEANS FOR AUDIO AND
VISUAL COMMUNICATION BETWEEN THE OPERATOR AND
THE PATIENT.

IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE

THAT ALL THE EXPOSURE PARAMETERS ARE CORRECT
BEFORE PERFORMING AN EXAM TO THE PATIENT, BY
VERIFYING THAT THE PARAMETER SELECTION HAS NOT
BEEN MODIFIED UNINTENTIONALLY OR BY THE CONTACT
OF EXTERNAL ELEMENTS ON THE CONTROL CONSOLE, IN
ORDER TO AVOID THE OVEREXPOSURE OR THE NEED OF
PERFORMING A NEW EXAM TO THE PATIENT.

MAKE SURE THAT THE X-RAY TUBE IS SET IN WORKING

POSITION WITH THE REFERENCE AXIS (X-RAY BEAM)
POINTING TO THE RECEPTION AREA.

2.3 MAXIMUM PERMISSIBLE DOSE (MPD)

Before operation, people 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

DISTANCE FROM THE FOCAL SPOT TO SKIN IN ORDER TO
KEEP THE ABSORBED DOSE AS LOW AS REASONABLY
ACHIEVABLE.

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2.4 RADIATION PROTECTION

Although this equipment 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 THE RESPONSIBILITY OF THE OPERATOR TO

RESTRICT ACCESS TO THE EQUIPMENT IN ACCORDANCE
WITH LOCAL REGULATIONS FOR RADIATION
PROTECTION.

Because exposure to X-ray radiation can be damaging to the health, use great
care to ensure 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 an 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 secondary radiation depends on the energy and
intensity of the primary beam and the atomic number of the object material
struck by the primary beam. Secondary radiation may be of greater intensity
than that of the radiation reaching the receptor. Take protective measures to
safeguard against this.

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. Lead screens 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.

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Observe the following rules for radiation protection of the

personnel in the examination room during X-ray exposures:

- Wear radiation protective clothing.

- Wear a personal dosemeter.

- Use the different recommended protective materials and

devices against radiation.

- While operating or servicing X-ray equipment, always keep

as large a distance as possible from the Focal Spot and X-ray
beam, never shorter than 2 meters, protect body and do not
expose hands, wrists, arms or other parts of the body to the
primary beam.

- Protect the patient against radiation outside the area of

interest by using protection accessories.

- Use the smallest X-ray field collimation. Make sure that the
area of interest will be completely exposed and the X-ray field
does not exceed the area of interest.

- Select a Focal Spot to patient skin distance (SID) as large

as possible to keep the absorbed dose for the patient as low
as reasonably possible.

The radiation dose decreases or increases according to the

Focal Spot to patient skin distance (SID): the greater the SID
distance, the lower the radiation dose. The radiation dose is
inversely proportional to the distance squared.

- Select as short an examination time as possible. This will

reduce total radiation dose considerably.

- Use Grids and Automatic Exposure Control with Ion

Chambers whenever possible.

- Place the region of interest as close as possible to the

image receptor. This will reduce exposure to radiation and
optimize the exposure.

- Be sure that audible and visual communication between

the patient and operator is established throughout the entire
examination.

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2.5 MONITORING OF PERSONNEL

Monitoring of personnel to determine the amount of radiation 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 SAFETY SYMBOLS

The following safety symbols may appear in the equipment.

Their meaning are described below.

Caution. Consult accompanying documents.

General Symbol. Follow operating instructions.

(Only applies to IEC 60601--1 Standard -- Third edition)

Safety Symbol. Follow instructions for use, especially those

instructions identified with Advisory Symbols to avoid any
risk for the Patient or Operator.
(Only applies to Standard IEC 60601--1:2005 and
IEC 60601--1:2005/AMD1:2012)

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General Mandatory action.

Type B applied part.

IPX0 Protection against harmful ingress of water or particulate matter.

IP Classification: Ordinary.

Ionizing radiation.

Non-ionizing electromagnetic radiation.

Radiation of Laser apparatus.

Do not stare into beam.
(Only applicable to equipment with Laser Pointer)

Dangerous voltage.

General warning, caution, risk of danger.

Warning: Ionizing radiation.

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Warning: Non-ionizing radiation.

Warning: Laser beam.

Warning: Dangerous voltage.

Warning: Do not place fingers between mobile and fixed parts of

the equipment, it may cause serious injuries to patient or operator.
As well, make sure the patient extremities are correctly positioned
into limit areas during operation, movement of parts may cause
serious damages to patient.

Electrostatic sensitive devices.

No pushing.

No sitting.

No stepping on surface.

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Stop (of action).

Emergency stop.

“ON” power.

“OFF” power.

“ON” / “OFF” (push-push).

Each position, “ON” or “OFF”, is a stable position.

Alternating current.

Three-phase alternating current.

Three-phase alternating current with neutral conductor.

N Connection point for the neutral conductor on Permanently

Installed equipment.

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Direct current.

Both direct and alternating current.

Protective Earth (Ground).

Earth (Ground).

This symbol according to the European Directive indicates that the

Waste of Electrical and Electronic Equipment (WEEE) must not be
disposed of 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.

This separate collection symbol is affixed to a battery or its

packing, to advise that the battery must be recycled or disposed of
in accordance with local or country laws. The letters below the
symbol indicate whether certain elements (Li=Lithium, PB=Lead,
CD=Cadmium, Hg=Mercury) are contained in the battery. All
batteries removed from the equipment must be properly recycled
Li/Pb/Cd/Hg or disposed. Please contact an authorized representative of the
manufacturer or an authorized waste management company for
information concerning the decommissioning of your equipment.

Pollution Control. (Only applicable to People’s Republic of China (PRC)).

This symbol indicates the product contains hazardous materials in
excess of the limits established by the Chinese Standards. It must
not be disposed of 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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2.7 REGULATORY

2.7.1 CERTIFICATIONS

The Positioners covered by this Operation Manual are authorized to be

marked with CE MARKING in accordance with the provisions of the Council
Directive 93/42/ EEC as amended by 2007/47/EC concerning Medical Devices.

Statement of Compliance with IEC 60601-1-3: Positioners with radiation

protection in accordance with IEC 60601--1--3:1994, IEC 60601--1--3:2008 and
IEC 60601--1--3:2008/AMD1:2013.

Statement of Compliance with IEC 60601-2-54: Positioners for Radiography

and/or Radioscopy in accordance with IEC 60601-2-54:2009 and
IEC 60601-2-54:2009/AMD1:2015.

Statement of Compliance with 21CFR Subchapter J: This product conforms to

DHHS radiation Standards of 21CFR subchapter J as of the date of
manufacture.

Note . Positioners model or type references are stated at the back of the
cover page of this document.

2.7.2 ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM

This equipment or system contains environmentally dangerous components

and materials (such as PCBs, 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.

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2.7.3 MODE OF OPERATION

 Continuous operation, in accordance with Standard IEC 60601--1:2005

and IEC 60601--1:2005/AMD1:2012.

 Permanently Installed Equipment.

2.7.4 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

Protection against electric shock hazards in accordance with Standards:

IEC 60601-1:1988, 2005 and 2012, IEC 60601-2-54:2009 and 2015.
This equipment has been classified as a type-B ( ) device, in accordance with
Standard IEC 60601-1 requirements: Class I -- Type B applied parts.

TO AVOID THE RISK OF ELECTRIC SHOCK, THIS

EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY
MAINS WITH PROTECTIVE EARTH.

ACCORDING TO MDD/93/42/CEE, THIS UNIT IS EQUIPPED

WITH EMC FILTERS. THE LACK OF PROPER GROUNDING
MAY PRODUCE ELECTRICAL SHOCK TO THE USER.

2.7.5 PROTECTION AGAINST HARMFUL INGRESS OF WATER OR PARTICULATE MATTER

Protection against harmful ingress of water or particulate matter: Ordinary

(IPx0), in accordance with Standard IEC 60601-1:1988, 2005 and 2012.

2.7.6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC

MIXTURES

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, in
accordance with Standard IEC 60601-1:1988, 2005 and 2012.

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2.7.7 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION

Protection against hazards from unwanted or excessive radiation in

accordance with Standard IEC 60601-1:1988, 2005 and 2012, and
IEC 60601-1-3:1994, 2008 and 2013.

2.7.8 DESIGNATED SIGNIFICANT ZONES OF OCCUPANCY

X-ray equipment specified for any radiological examination shall have at least
one Significant zone of Occupancy for the use of the operator and staff,
designated as follows:

 Selection and control of modes of operation.

 Selection of loading factors for the exposure.

 Actuation of the exposure controls.

 Other necessary controls for the operator during exposure.

Next illustration shows an example of the “Significant Zone of Occupancy”.

Generator

CONTROL CONSOLE,
REMOTE ON/OFF OR
DIGITAL WORKSTATION Table Base
ROOM

PROTECTED AREA /
NO RADIATION AREA PATIENT ENVIRONMENT

OPERATOR ENVIRONMENT

SIGNIFICANT ZONE
OF OCCUPANCY EXAM ROOM

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2.8 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 to radio
communications.

To provide reasonable protection against such interference, this equipment

complies with emissions limits for a Group 1 -- Class A Medical Devices
Directive as stated in IEC 60601--1--2: 2007 and 2014. 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 of the 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 applicable to an electromagnetic interference for

a Group 1 -- Class A Medical Device, 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 European Union Medical Device Directive and of
Federal Communications Commission regulations.

Before using this equipment make sure that all requirements

about EMC included in this manual are accomplished.

Should any interference (EMC) be detected with other

equipment, please position other equipment away from this
one.

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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: 2007 and 2014 Tables as
described in this section.

The manufacturer is not responsible for any interference

caused by using other than recommended interconnect
cables, accessories and transducers or by unauthorized
changes or modifications to this equipment.

GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC EMISSIONS

(IEC 60601-1-2:2007 AND IEC 60601-1-2:2014)

This X-ray Unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this Portable X-ray Unit should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment -- guidance

This X-ray Unit uses RF energy only for its

RF emissions internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions
Class A
CISPR 11
This X-ray Unit is suitable for use in all
establishments other than domestic and those
Harmonic emissions
Class A directly connected to the public low--voltage
IEC 61000--3--2
power supply network that supplies buildings
used for domestic purposes.
Voltage fluctuations/flicker emissions
Complies
IEC 61000--3--3

NOTE - In accordance with Standard IEC 61601-1-2:2014, the emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 Class A. If it is used in a residential environment (for which CISPR 11 Class B is normally required) this equipment might not
offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or
re-orientating the equipment.

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GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2007)

This X-ray Unit is intended for use in the electromagnetic environment specified below.
The customer or the user of this X-ray Unit should assure that it is used in such an environment.

IEC 60601-1-2:2007
Immunity Test Compliance Level Electromagnetic environment -- Guidance
Test level

Electrostatic discharge
¦ 6kV contact ¦ 6kV maximum Floors should be wood, concrete or ceramic
(ESD)
tile. If floors are covered with synthetic material,
¦ 8kV air ¦ 8kV maximum the relative humidity should be at least 30%.
IEC 61000-4-2

¦ 2kV ¦ 2kV
Electrical fast
for power supply lines for power supply lines
transient/burst Mains power quality should be that of a typical
commercial or hospital environment.
IEC 61000-4-4 1kV
¦ ¦ 1kV
for input/output lines for input/output lines

¦ 1kV
Surge ¦ 1kV line(s) to line(s)
symmetrical coupling Mains power quality should be that of a typical
commercial or hospital environment.
IEC 61000--4--5 ¦ 2kV line(s) to earth
¦ 2kV asymmetrical coupling

< 5% UT >95%
(>95% dip in UT) for 0.5 periods
for 0.5 cycle

40% UT 60%
Mains power quality should be that of a typical
Voltage dips, short (60% dip in UT) for 5 periods
commercial or hospital environment. If the user
interruptions and voltage for 5 cycles
of the Portable X-ray Unit requires continued
variations on power
operation during power mains interruptions, it is
supply input lines.
recommended that the Portable X-ray Unit be
70% UT 30%
powered from a uninterruptible power supply or
IEC 61000--4--11 (30% dip in UT)
a battery
for 25 cycles

< 5% UT >95%
(>95% dip in UT) for 250 periods
for 5s

Power frequency (50/60

Power frequency magnetic fields should be at
Hz) magnetic field
3 A/m 3A/m levels characteristic of a typical location in a
typical commercial or hospital environment.
IEC 61000--4--8

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

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2007)

This X-ray System is intended for use in an electromagnetic environment specified below.
The customer or Operator of this X-ray System should assure that it is used in such an environment.

IEC 60601-1-2:2007 Compliance

Immunity Test Electromagnetic environment - guidance
Test Level Level

Portable and mobile RF communications equipment

should be used no closer to any part of this X-ray
System, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3 Vrms 

IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz d = 1.2 P
d = 1.2 P , 80 MHz to 800 MHz
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz d = 2.3 P, 800 MHz to 2.5 GHz

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:

NOTE 1 -- At 80 MHz and 800 MHz, 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.

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 X-ray System is used exceeds the applicable RF compliance level above, this X-ray System
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 System.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE

AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE X-RAY SYSTEM
(IEC 61601-1-2:2007)

This X-ray System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of this X-ray System can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the X-ray System as recommended below,
according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

m
Rated maximum output power of transmitter

W 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 P d = 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

TYPICAL RF DEVICES (Worst-Case scenario)

Recommended
Device: Power @ Frequency
distance(m)

GMRS device (Professional Walkie--Talkie): 5 W @ 462--467 MHz 2.7

GSM / UMTS cell phone: 2 W @ 850/1700/1900 MHz 3.3

FRS device (Amateur Walkie--Talkie): 500 mW @ 462--467 MHz 0.9

WiFi / Bluetooth devices: 100 mW @ 2400--2500 MHz 0.8

DECT devices (modern cordless phones): 100mW @ 1880--1900 MHz 0.8

RFID reader (3): 10 mW @ 125--150 KHz / 13.56 MHz 0.12

RFID reader (3): 10 mW @ 902--928 MHz / 2400--2500 MHz 0.23

Station transmitter ATSC TV broadcasting: 100 kW @ 54--800 MHz 380

Station transmitter ATSC TV broadcasting: 100 kW @ 800--890 MHz 730

Station transmitter FM radio broadcasting: 100 kW @ 87.5--108 MHz 380

For transmitters rated at a maximum output power not listed above, the recommended separation distance ’d’ in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where ’P’ is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

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 reflection from
structures, objects and people.

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 61601-1-2:2014)

This X-ray System is intended for use in the electromagnetic environment specified below.
The customer or Operator of this X-ray System should assure that it is used in such an environment.

IEC 60601-1-2:2014 Electromagnetic

Immunity Test Compliance Level
Test Level environment - guidance

¦ 8 kV contact ¦ 8 kV contact
Floors should be wood, concrete or
Electrostatic discharge (ESD) ceramic tile.
If floors are covered with synthetic
¦ 2 kV, ¦  kV, ¦ 8 kV, ¦ 2 kV, ¦  kV, ¦ 8 kV, material, the relative humidity
IEC 61000-4-2
¦ 15 kV air ¦ 15 kV air should be at least 30 %.

¦ 2 kV for power supply lines ¦ 2 kV for power supply lines

Electrical fast transient/burst Mains power quality should be that
¦ 1 kV for input/output lines ¦ 1 kV for input/output lines of a typical commercial or hospital
IEC 61000-4-4 environment.
(100 kHz repetition frequency) (100 kHz repetition frequency)

¦ 0.5 kV, ¦ 1 kV ¦ 0.5 kV, ¦ 1 kV

Surge line(s) to line(s) line(s) to line(s) Mains power quality should be that
of a typical commercial or hospital
IEC 61000-4-5 ¦ 0.5 kV, ¦ 1 kV, ¦ 2 kV ¦ 0.5 kV, ¦ 1 kV, ¦ 2 kV environment.
line(s) to earth line(s) to earth

0% UT for 0.5 cycle 0% UT for 0.5 cycle

at 0o, 45o, 90o,135o, 180o, at 0o, 45o, 90o,135o, 180o,
225o, 270o and 315o 225o, 270o and 315o

Mains power quality should be that

of a typical commercial or hospital
0 % UT for 1 cycle 0 % UT for 1 cycle
Voltage dips, short interruptions environment. If the user of the This
at 0o at 0o
and voltage variations on power X-ray System requires continued
supply input lines. operation during power mains
interruptions, it is recommended
IEC 61000-4-11 that this X-ray System is powered
from an Uninterruptible Power
70 % UT for 25/30 cycles 70 % UT for 25/30 cycles
Supply or a battery.
at 0o at 0o

0% UT 250/300 cycles 0% UT 250/300 cycles

Power frequency magnetic fields

Power frequency (50/60 Hz)
should be at levels characteristic of
magnetic field
30 A/m 30 A/m a typical location in a typical
commercial or hospital
IEC 61000-4-8
environment.

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

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GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

(IEC 60601-1-2:2014)

This X-ray System is intended for use in an electromagnetic environment specified below.
The customer or Operator of this X-ray System should assure that it is used in such an environment.

IEC 60601-1-2:2014 Electromagnetic environment -

Immunity Test Compliance Level
Test Level guidance

Radiated RF EM fields 3 Vrms 3 Vrms

IEC 61000-4-3 from 80 MHz to 2.7 GHz from 80 MHz to 2.7 GHz
(80% AM at 1 kHz) (80% AM at 1 kHz)

Proximity fields from RF Refer to next table “IMMUNITY Refer to next table “IMMUNITY
wireless Communications REQUIREMENTS FOR RF REQUIREMENTS FOR RF Portable RF communications equipment
equipment WIRELESS COMMUNICATIONS WIRELESS COMMUNICATIONS (including peripherals such as antenna
IEC 61000-4-3 EQUIPMENT” EQUIPMENT” cables and external antennas) should be
used no closer than 30 cm to any part of the
equipment, including cables specified by
manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Conducted disturbances 3 Vrms 3 Vrms
induced by RF fields from 150 kHz to 80 Mhz from 150 kHz to 80 Mhz
IEC 61000-4-6
6 Vrms in ISM bands 6 Vrms in ISM bands
from 150 kHz to 80 MHz from 150 kHz to 80 MHz

(80% AM at 1 kHz) (80% AM at 1 kHz)

NOTE -- The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;
26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz
to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz to 18.17 MHz; 21.0 MHz to 21.4 MHz; 24.89 MHz to 24.99 MHz; 28.0 MHz to 29.7 MHz; and 50.0 MHz
to 54.0 MHz.

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IMMUNITY REQUIREMENTS TO RF WIRELESS COMMUNICATIONS EQUIPMENT

(IEC 60601-1-2:2014)

This X-ray System is intended for use in an electromagnetic environment specified below.
The customer or Operator of this X-ray System should assure that it is used in such an environment.

Band a) Distance Immunity Test Level

Modulation b)
(MHz) (m) (V/m)

Pulse modulation b)
380 -- 390 27
18 Hz

FM c)
430 -- 470 ¦5 kHz deviation 28
1 kHz sine

Pulse modulation b)
704 -- 787 9
217Hz

Pulse modulation b)
800 -- 960 28
18Hz 0.3

Pulse modulation b)
1700 -- 1990 28
217Hz

Pulse modulation b)
2400 -- 2570 28
217Hz

Pulse modulation b)
5100 -- 5800 9
217Hz

a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.

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2.9 QUANTITATIVE INFORMATION

Note . The following tables show the Quantitative Information associated

to this equipment according with the Standard IEC 60601--1--3:2008
and IEC 60601--1--3:2008/AMD1:2013. These tables illustrate
loading factors for image performance and supply Dose indication
examples. Therefore, these tables are an instance of the
adjustment of Loading Factors, Focal Spot Selection, SID and
Collimator opening, which affect to the radiation quality or to the
radiation dose rate applied in normal use.

2.9.1 FUNCTIONAL TESTS PERFORMED TO OBTAIN THE QUANTITATIVE INFORMATION

Equipment:

 Rad Positioner with Ralco Collimator.

Instrumentation used:

 Dosimeter: Vacudap

 Dosimeter: Unfors

 Rectangular Phantom made of Polymethyl-methacrylate (PMMA)

layers: 25 cm x 25 cm x 20 cm.

Test Details:

 Minimum SID distance from Table:100 cm.

 Maximum SID distance from Wall Stand:180 cm.

 Open Collimator size: 13 cm x 13 cm (min.), 43 cm x 43 cm (max.)

 The measurements were made with the exposure parameters shown on

the results table:
KVp Range: 40 KVp, 60 KVp, 80 KVp, 100 KVp, 125 KVp
mAs Range: 1 mAs, 2 mAs, 10 mAs, 50 mAs, 100 mAs

 Performed measurements of Air Kerma or Air Kerma Rate at the

following designated positions:
-- Distance SID doses
-- Patient (Phantom) Entrance doses and Entrance doses Rate
-- Patient (Phantom) Output doses and Output doses Rate
-- Collimator Output doses

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Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate

Collimator blades

Input Dose Rate

Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 0.2 0.016 0.025 7.479 10.795 0.036

100 0.1 10 Small 1.1 0.087 0.136 4.906 7.682 0.213

13 13
13x13
200 0.5 100 Large 11 0.836 1.307 9.407 14.125 1.962

400 1 400 Large 40 3.073 4.802 17.286 23.863 6.629

100
160 0.012 2 Small 2.1 0.016 0.025 7.615 18.691 0.062

100 0.1 10 Small 11.8 0.090 0.140 5.038 13.354 0.371

43 43
43x43
200 0.5 100 Large 107.1 0.862 1.347 9.698 23.798 3.305

400 1 400 Large 391.3 3.166 4.947 17.809 41.228 11.452

40 16
1.6
160 0.012 2 Small 0.2 0.005 0.006 1.865 4.273 0.014

100 0.1 10 Small 1.1 0.027 0.034 1.214 3.453 0.096

13 13
13x13
200 0.5 100 Large 11 0.257 0.325 2.343 5.985 0.831

400 1 400 Large 40 0.940 1.190 4.283 11.723 3.257

180
160 0.012 2 Small 2.1 0.005 0.007 1.962 6.243 0.021

100 0.1 10 Small 11.8 0.028 0.035 1.269 4.420 0.123

43 43
43x43
200 0.5 100 Large 107.1 0.267 0.338 2.432 7.400 1.028

400 1 400 Large 391.3 0.979 1.239 4.461 12.763 3.545

Note . Combined standard uncertainty is ¦35%

(IEC 60580:2000 / 60601-2-54:2009
and IEC 60601--2--54:2009/AMD1:2015).

OM-0527R5 29
Standard and Auto-tracking Ceiling Suspension
Operation

Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate

Collimator blades

Input Dose Rate

Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 0.6 0.046 0.072 21.746 113.713 0.379

100 0.1 10 Small 3.9 0.252 0.394 14.195 79.388 2.205

13 13
13x13
200 0.5 100 Large 39.4 2.587 4.042 29.103 157.649 21.896

400 1 400 Large 191.4 10.009 15.639 56.299 295.137 81.983

100
160 0.012 2 Small 7.5 0.048 0.074 22.299 233.322 0.778

100 0.1 10 Small 40.6 0.265 0.414 14.894 161.562 4.488

43 43
43x43
200 0.5 100 Large 389.3 2.691 4.205 30.277 320.682 44.539

400 1 400 Large 1491.3 10.435 16.304 58.696 596.348 165.652

60 22
2.2
160 0.012 2 Small 0.6 0.014 0.018 5.345 53.374 0.178

100 0.1 10 Small 3.9 0.078 0.098 3.538 36.438 1.012

13 13
13x13
200 0.5 100 Large 39.4 0.796 1.007 7.251 72.125 10.017

400 1 400 Large 191.4 3.078 3.896 14.025 145.377 40.383

180
160 0.012 2 Small 7.5 0.015 0.019 5.677 71.217 0.237

100 0.1 10 Small 40.6 0.082 0.103 3.717 48.584 1.350

43 43
43x43
200 0.5 100 Large 389.3 0.832 1.053 7.582 96.355 13.383

400 1 400 Large 1491.4 3.219 4.074 14.667 179.186 49.774

Note . Combined standard uncertainty is ¦35%

(IEC 60580:2000 / 60601-2-54:2009
and IEC 60601--2--54:2009/AMD1:2015).

30 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate

Collimator blades

Input Dose Rate

Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 1.4 0.087 0.136 40.753 378.000 1.260

100 0.1 10 Small 7.4 0.461 0.702 25.909 256.070 7.113

13 13
13x13
200 0.5 100 Large 74.5 4.674 7.303 52.582 511.763 71.078

400 1 400 Large 366.7 18.374 28.709 103.353 982.017 272.783

100
160 0.012 2 Small 14.3 0.090 0.141 42.391 829.043 2.763

100 0.1 10 Small 77 0.483 0.754 27.162 553.148 15.365

43x43
200 0.5 100 Large 735.9 4.884 7.632 54.949 1099.40 152.696
9

400 1 400 Large 2856.2 19.209 30.014 108.049 2111.165 586.435

80 2.9
160 0.012 2 Small 1.4 0.026 0.033 9.931 181.096 0.604

100 0.1 10 Small 7.2 0.142 0.179 6.462 120.177 3.338

13 13
13x13
200 0.5 100 Large 74.5 1.449 1.834 13.201 239.228 33.226

400 1 400 Large 366.7 5.703 7.218 25.986 480.835 133.565

180
160 0.012 2 Small 14.3 0.027 0.035 10.419 249.574 0.832

100 0.1 10 Small 77 0.149 0.189 6.799 162.094 4.503

43 43
43x43
200 0.5 100 Large 735.9 1.520 1.924 13.851 328.883 45.678

400 1 400 Large 2856.2 5.988 7.578 27.282 632.661 175.739

Note . Combined standard uncertainty is ¦35%

(IEC 60580:2000 / 60601-2-54:2009
and IEC 60601--2--54:2009/AMD1:2015).

OM-0527R5 31
Standard and Auto-tracking Ceiling Suspension
Operation

Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate

Collimator blades

Input Dose Rate

Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 2.1 0.131 0.205 61.550 854.348 2.848

100 0.1 10 Large 11.2 0.698 1.091 39.282 562.852 15.635

13x13
200 0.5 100 Large 113 7.136 11.149 80.276 1132.591 157.304

400 1 400 Large 448.9 28.400 44.375 127.800 1784.09 619.478

7

160 0.012 2 Small 21 0.137 0.215 64.362 1829.47 6.098

100
8

100 0.1 10 Large 114.8 0.735 0.140 41.371 1221.80 33.939

9
43 43
43x43
200 0.5 100 Large 1067.6 7.491 1.347 84.277 2346.57 325.913
4
100 400 1 400 Large 3.6 4373 29.791 4.947 134.061 3901.77 1354.78
4

160 0.012 2 Small 2.1 0.040 0.006 15.334 396.261 1.321

100 0.1 10 Large 11.2 0.217 0.034 9.877 263.614 7.323

13 13
13x13
200 0.5 100 Large 113 2.224 0.325 20.269 536.807 74.557

400 1 400 Large 448.9 8.878 1.190 32.361 861.997 299.304

180
160 0.012 2 Small 21 0.043 0.007 16.187 555.391 1.851

100 0.1 10 Large 114.8 0.228 0.035 10.404 363.757 10.104

43 43
43x43
200 0.5 100 Large 1067.6 2.334 0.338 21.268 743.791 103.304

400 1 400 Large 4373 9.313 1.239 33.946 1173.788 407.565

Note . Combined standard uncertainty is ¦35%

(IEC 60580:2000 / 60601-2-54:2009
and IEC 60601--2--54:2009/AMD1:2015).

32 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate

Collimator blades

Input Dose Rate

Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 2.9 0.194 0.303 90.897 1611.652 5.372

100 0.1 10 Large 19.1 1.037 1.620 58.304 7.682 0.213

13x13
200 0.5 100 Large 164.1 10.722 16.753 120.620 2195.06 304.870
1

400 1 400 Large 823.7 43.078 67.310 121.158 2211.652 1228.696

160 0.012 2 Small 29.7 0.204 0.319 95.666 3558.26 11.861

100
1

100 0.1 10 Large 163.4 1.090 1.704 61.337 2407.61 66.878

7
43 43
43x43
200 0.5 100 Large 1595.2 11.243 17.568 126.489 4963.61 689.391
7

400 1 400 Large 5679.6 45.270 70.734 127.321 4418.60 2454.783

9
125 45
4.5
160 0.012 2 Small 2.9 0.058 0.073 21.923 776.609 2.589

100 0.1 10 Large 19.1 0.317 0.401 14.449 520.278 14.452

200 0.5 100 Large 13x13 164.1 3.349 4.238 30.515 1068.73 148.435
0

400 1 400 Large 823.7 13.470 17.047 30.685 1072.48 595.826

7
180
160 0.012 2 Small 29.7 0.062 0.078 23.395 1085.47 3.618
8

100 0.1 10 Large 163.4 0.338 0.428 15.416 728.765 20.243

43x43
200 0.5 100 Large 1595.2 3.523 4.459 32.108 1509.49 209.652
6

400 1 400 Large 5679.6 14.191 17.961 32.330 1515.91 842.174

3

Note . Combined standard uncertainty is ¦35%

(IEC 60580:2000 / 60601-2-54:2009
and IEC 60601--2--54:2009/AMD1:2015).

OM-0527R5 33
Standard and Auto-tracking Ceiling Suspension
Operation

Quantitative Information

Loading Factors Parameter Selection Filtrat. Measured Doses

Source--Image Distance

(min. value allowed)

Output Dose Rate

Collimator blades

Input Dose Rate

Output Dose

Output Dose
Input Dose
Focal Spot

Collimator

SID Dose
Selection

(μGy*m2)

Phantom

Phantom

Phantom

Phantom
opening
Time (s)

(mGy/h)
(mmAl)

(mGy)

(mGy)

(Gy/h)

(μGy)
mAs

HVL
(cm)

(cm)
KVp

SID
mA

160 0.012 2 Small 3.8 0.253 0.395 118.573 2493.39 8.311

1

100 0.1 10 Large 24.4 1.375 2.148 77.331 1679.79 46.661

1
13 13
13x13
200 0.5 100 Large 239.3 14.530 22.704 163.467 3508.59 487.304
1

400 1 400 Large 882.9 59.548 93.043 133.983 2882.50 2001.739

4
100
160 0.012 2 Small 38.5 0.262 0.409 122.731 5744.34 19.148
8

100 0.1 10 Large 210.7 1.444 2.257 81.244 3862.95 107.304

7
43 43
43x43
200 0.5 100 Large 2124.2 15.252 23.832 171.587 8057.73 1119.130
9

400 1 400 Large 8581.3 62.748 98.043 141.183 6629.00 4603.478

150
50 5.4
5 9

160 0.012 2 Small 3.8 0.077 0.098 29.337 1208.08 4.027

7

100 0.1 10 Large 24.4 0.426 0.539 19.410 819.235 22.757

13x13
200 0.5 100 Large 239.3 4.548 5.756 41.442 1714.22 238.087
6

400 1 400 Large 882.9 18.687 23.651 34.057 1409.94 979.130

8
180
160 0.012 2 Small 38.5 0.080 0.102 30.467 1700.87 5.670
0

100 0.1 10 Large 210.7 0.453 0.573 20.646 1152.939 32.026

43x43
200 0.5 100 Large 2124.2 4.803 6.078 43.764 2436.73 338.435
0

400 1 400 Large 8581.3 19.748 24.993 35.990 2005.98 1393.043

3

Note . Combined standard uncertainty is ¦35%

(IEC 60580:2000 / 60601-2-54:2009
and IEC 60601--2--54:2009/AMD1:2015).

34 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

2.10 DETERMINISTIC EFFECTS

Deterministic effects may occur when the Radiation dose to a certain organ or
tissue exceeds a specific threshold. Particular organs or tissues of such
concern in diagnostic Radiology are the skin and the eye lens. The numerical
value of the threshold dose is in the range between 1 Gy and 3 Gy.

As shown in the Quantitative Information Tables, the radiation dose effects

measured in this equipment are below the threshold in which the severity of
certain effects would take place on human skin or eyes lens.

This mentioned threshold was established by the International Commission on

Radiological Protection (ICRP Publication No 60).

Quantitative Information tables (Refer to Section 2.9) illustrate examples of

available loading factors for image performance and supply Dose indication,
which affect to the radiation quality or to the radiation dose rate applied in normal
use.

As indicated in the Quantitative Information Tables, the number of exposures

needed to reach the previously described maximum radiation values will
depend on the selected techniques for each radiographic study.

OM-0527R5 35
Standard and Auto-tracking Ceiling Suspension
Operation

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36 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

SECTION 3 OPERATING SEQUENCES

3.1 POWER ON/OFF

All the equipments of the X-ray Room and the X-ray Generator should be
powered by the same Room Cabinet, so the whole System will be turned
ON/OFF at the same time.

The Suspension is connected to the Electrical Cabinet and feeds the Table. At
the same time, the table feeds the Wall Stand. Switch ON/OFF the Room
Electrical Cabinet to power ON/OFF the Ceiling Suspension and the Whole
Room.

BEFORE POWERING ON THE UNIT, CHECK THAT THERE IS

NO OBJECT OR OBSTACLE ON THE TUBE SUPPORT OR
THE L-BLOCK SURFACE FOR THE CORRECT MOTION OF
THE SUSPENSION.

3.2 X-RAY TUBE WARM-UP PROCEDURE

Before effecting X-ray exposures ensure that the X-ray Tube

is properly warmed-up. Make sure that no people will be
inadvertently exposed to unnecessary X-rays during this
procedure.

Routine exposures should not be effected unless the X-ray Tube is previously
warmed-up, this prolongs X-ray Tube life.

It is recommended that the following procedure will be performed for X-ray Tube
warm-up, at the start of each day and when the X-ray Tube selected has not
been in use for approximately one hour.

This warm-up procedure is used for a typical X-ray Tube.

Consult the X-ray Tube manufacturer instructions for the
current X-ray Tube in use, comparing its recommendations
with this procedure. If there is conflict with this procedure,
comply with the X-ray Tube manufacturer’s instructions.

OM-0527R5 37
Standard and Auto-tracking Ceiling Suspension
Operation

Perform X-ray Tube warm-up as follows:

 Close the collimator blades fully.

 Select 70 kVp, 100 mAs, 200 mA and 500 ms exposure.

 Make sure that no one will be exposed.

 Make a total of three exposures, 15 seconds apart.

Excessive filament evaporation shortens X-ray Tube life.

Minimize evaporation by keeping Exposure “Preparation”
time to an absolute minimum.

3.3 RADIOGRAPHIC OPERATION

A typical examination sequence is as indicated below:

1. Make sure that the X-ray Tube is properly warmed-up.

2. Position the patient for the examination.

3. Maintain the patient at the required position. Prepare the X-ray Tube by
pressing the Handswitch button to the “Prep” position and maintain it until
the “Ready” indicator is illuminated.

4. Carry out an X-ray exposure by pressing the Handswitch button fully to

the “Exp” position, maintaining it pressed throughout the exposure. The
“X-ray On” indicator will light and an audible signal will sound during the
exposure.

5. When the exposure is finished, release the push-button.

6. Repeat the procedure if additional exposures are desired.

38 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

SECTION 4 OPERATION

4.1 COMPONENTS OF THE EQUIPMENT

Illustration 4-1
Ceiling Suspension Nomenclature

Longitudinal Rails
Transversal Rails

Carriage

Telescopic Column

Hose Emergency-OFF Switch (Automatic Model)

Control Console

L-block Collimator

RAIL SYSTEM

The Rail System is formed by two pairs of rails made of aluminum and available
in different lengths. The rails allow the displacement of the Carriage along the
Longitudinal and Transversal Axis.

Longitudinal Rails or Axis (X), different lengths extrusion bars which fix the
Ceiling Suspension to the ceiling. Longitudinal rails are available in the following
lengths: 3358 mm (132.22”), 4019 mm (158.22”), 4679 mm (184.22”), 5340 mm
(210.22”) and 6000 mm (236.22”).

Transversal Rails or Axis (Y), an horizontal structure fixed to the Longitudinal

Rails by two bearings assemblies that allow the movement along the
Longitudinal Rails. The bearings also maintain the alignment of the Transversal
Rails with the Table. Transversal rails are available in the following lengths:
2000 mm (78.74”), 2250 mm (88.58”), 2500 mm (98.42”), 2750 mm (108.27”),
3000 mm (118.11”) and 3500 mm (137.80”).

OM-0527R5 39
Standard and Auto-tracking Ceiling Suspension
Operation

The equipment may be provided with a Cable Support Rail, an unistrut rail with
the same length of the Longitudinal Rails, located behind the back Longitudinal
Rail.

Illustration 4-2
Ceiling Suspension Axes and travels

Up
Vertical Axis (Z)

¦135o
X-ray Tube Angulation
Down

in Alpha Axis

¦180o
X-ray Tube Rotation
in Beta Axis

40 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

CARRIAGE

The Carriage contains some electronic and mechanical components of the

Ceiling Suspension and supports the Telescopic Column, L-Block Assembly,
X-ray Tube Support with the Tube, Collimator and Control Console.

The Carriage is marked with orange and pink arrows to match the Transversal
and Longitudinal Brake Buttons of the Control Console, respectively.

Illustration 4-3
Carriage

Transversal Movement

Longitudinal Movement

TELESCOPIC COLUMN

It is composed of four different sized hexagonal tubes of steel. Fixed to the

Carriage, the Telescopic Column allows vertical movement of the X-ray Tube
Assembly in the Vertical Axis (Z). This motion is controlled by the Vertical Brake.

The Focal Spot vertical travel is 1570 mm (61.8”). The minimum distance
Focus-Ceiling is 737 mm (29”) and the maximum distance is 2307 mm (90.8”).

L-BLOCK ASSEMBLY

This assembly is the junction between the Telescopic Column and the X-ray
Tube and Collimator Assembly. It contains electronic and the mechanical
components to allow the movement of the X-ray Tube in the Alpha Axis
(Angulation) and Beta Axis (Rotation).

OM-0527R5 41
Standard and Auto-tracking Ceiling Suspension
Operation

X-RAY TUBE SUPPORT

It is designed to support the X-ray Tube, which can rotate around the vertical
Axis of the Telescopic Column (Beta Axis) ¦180o from the front position (0o),
and it can rotate around its transversal Axis (Alpha Axis) ¦135o from 0o position
(perpendicular to the floor).

The Suspension can be associated with the following X-ray tubes:

ANODE HEAT
HOUSING INSERT FOCAL SPOT TARGET ANGLE SPEED
CAPACITY (KHU)

Toshiba E7100X N/A 0.6 -- 1.2 12o 300 High/Low

Toshiba E7239X &FX N/A 1.0 -- 2.0 16o 140 Low

Toshiba E7240X & FX N/A 0.6 -- 1.2 12o 140 Low

Toshiba E7242X & FX N/A 0.6 -- 1.5 14o 200 Low

Toshiba E7252X & FX N/A 0.6 -- 1.2 12o 300 High/Low

Toshiba E7254X & FX N/A 0.6 -- 1.2 12o 400 High/Low

Toshiba E7299X N/A 0.3 -- 1 12o 140 Low

Toshiba E7843X N/A 0.6 -- 1.2 12o 150 Low

Toshiba E7865X N/A 0.3 -- 1 12o 140 Low

Toshiba E7869X N/A 0.6 -- 1.2 12o 600 High/Low

Toshiba E7876X N/A 0.6 -- 1.2 12o 230 Low

Toshiba E7884X N/A 0.6 -- 1.2 12o 300 Low

Varian B130 Any one of 100 mm Variable depending on the insert High/Low
(4”)

Varian Sapphire Any one of 100 mm Variable depending on the insert High/Low
(4”)

Varian Diamond Any one of 71 mm Variable depending on the insert High/Low

(2,8”)

42 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

Tube adaptation kits will be supplied to allow the correct assembly and fixation
of the X-ray tubes to the ceiling suspension and provide compatibility. Each of
these adaptation kits is compound of fixation rings, console fixture and
suspension fixture. All components are designed for the specific characteristics
of the X-ray tubes (type, dimensions, weight...).

Note . Only tubes with a horn angle between 90 o and 180 o can be
mounted on the suspension.

Illustration 4-4
Allowed orientations for Tubes

180o

90o 0o

COLLIMATOR

The Suspension can be associated with three Collimation options:

 Ralco R225/R225 DHHS Manual Collimator.

 Ralco R225ACS Automatic Collimator.

Illustration 4-5
Collimators

Manual Collimator Automatic Collimator

OM-0527R5 43
Standard and Auto-tracking Ceiling Suspension
Operation

CONTROL CONSOLE

The Control Console enables the operator to control the movements of the Ceiling
Suspension and also the Auto-tracking function.

Brake Buttons are used to control each axis brake/movement. When a button is
pressed and held, the brake is released, so the equipment can be moved in the
free axis. Once released the button, the brake is activated and the motion stops.

There are two different types of Control Consoles depending on the Suspension
model: the Standard and the Auto-tracking Control Console. Both are similar
but the Auto-tracking Control Console is provided with an additional button to
control the Auto-tracking function.

Illustration 4-6
Control Consoles and Brake Buttons

STANDARD CONTROL CONSOLE AUTO-TRACKING CONTROL CONSOLE

Auto-tracking ON/OFF

Display SID Brake Buttons

ANG

Omni-directional Brake Button

Alpha Axis Brake. Angle of the X-ray Tube. Longitudinal Axis Brake. Right & Left.

Omni-directional Brake. Transversal and

Transversal Axis Brake. Back & Front. Longitudinal. Other Axes could be also
activated according to the configuration during
installation.

Vertical Axis Brake. Up & Down. Beta Axis Brake. Rotation of the X-ray Tube.

Wheel Omni-directional Brake. Transversal and Longitudinal. Other Axes could be also activated according to the configuration
during installation.

Use always the Control Console Wheel to drive all manual movements of the
Ceiling Suspension. Otherwise, operator could get injured due to the potential
pinch points areas.

44 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

In the analog Control Console it is displayed:

 SID. Distance from the Focal Spot to the Receptor. It is displayed in cm

or inches, depending on the Console Display configuration. SID can be:

G Vertical. The X-ray Tube beam points to the Table Receptor.

G Horizontal. The X-ray Tube beam points to the Wall Stand

Receptor.

Note . When working on RSA MODE, the SID indicates in all cases the
distance to the Table Detector or the floor, depending on the
configured reference point.

 ANG or X-Ray Tube Angulation. It indicates the Angulation degrees of

the Tube Support, values are ranged between:
G 0o. The X-ray tube beam points the Table Receptor.

G 90o. The X-ray tube beam points to the Wall Stand Receptor.

4.2 MOVEMENTS

THIS EQUIPMENT CAN BE MOVED IN DIFFERENT AXIS.

PLEASE TAKE CARE THAT NEITHER THE PATIENT IS IN THE
MIDDLE OF THE TRAVEL. REMOVE ALL OBJECTS FROM
THE COLLISION AREA.

THE FOLLOWING SKETCH INDICATES DANGEROUS

LOCATIONS WHERE PATIENT OR OPERATOR CAN BE
INJURED OR PINCHED. PLEASE PAY ATTENTION THAT
NEITHER THE PATIENT NOR OPERATOR GET PINCHED OR
HURT IN THIS AREA.

OM-0527R5 45
Standard and Auto-tracking Ceiling Suspension
Operation

4.2.1 MANUAL MOVEMENTS

The Ceiling Suspension can be moved in one direction, two directions at the
same time or even simultaneously on vertical, transversal and longitudinal
directions. In case of moving the Suspension in just one axis, proceed as follow:

1. Press and hold the corresponding Button on the console. The brake will
be released.

BEFORE POWERING ON AND MOVING THE UNIT, CHECK

THAT THERE IS NO OBJECT OR OBSTACLE ON THE TUBE
SUPPORT OR ON THE L-BLOCK SURFACE FOR THE
CORRECT MOTION OF THE SUSPENSION.

2. Move manually the Suspension to the desired position.

3. Release the Button. This will activate the brake again.

To carry out simultaneous movements on different axes use the

Omni-directional pushbutton or the button located on the Wheel of the Console.
Then move manually the Suspension up to the desired direction. It is just
possible to move the Ceiling Suspension on Alpha and Beta Axes when their
corresponding Brake Button is pressed and held.

Note . Due to the motorized assisted movement in the Vertical Axis.

move up/down slowly the X-ray Tube Assembly because, in case
of making higher effort than the required, more difficult will be to
raise and lower it.

4.2.2 DETENT POINTS

Each axis can be configured to have several Detent Points that allow to get the
Suspension exactly at the correct position to work with the Table and Wall
Stand.

Move slowly the equipment to get the Detent Assembly locked at the correct
position. Once the equipment is locked, the Brakes get activated. Release
again any brake to move and get unlocked the Ceiling Suspension.

46 OM-0527R5
 Standard and Auto-tracking Ceiling Suspension
Operation

Depending on the System Layout these working positions are different.

 On the Longitudinal and Transversal Axes, the Detent Assemblies are

mechanical, they are composed by Position Markers and the Detent
Assemblies.
The Position Markers are installed on the Transversal Rail and the
Carriage, they indicate the exact position for the proper alignment of the
X-ray Tube with both Receptors and the SID distaces from the Wall
Stand.

 On the Vertical Axis there is just one electromechanical Detent Point

available to be defined during installation. It is configured at the desired
default SID to the Table.

 On the Alpha and Beta Axes, Detent Points are configured by default at
each 45o.

Illustration 4-7
Alpha and Beta Detents

Alpha Axis Detents Beta Axis Detents

±135o ±180o
(X-ray Tube Angulation) (X-ray Tube Rotation)

180o
Focal Spot
-135o 135o
-135o 135o

-90o 90o
-90o 90o

Focal Spot

-45o 45o
-45o 45o

0o
0o

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4.2.3 AUTO-TRACKING FUNCTION

This function is just available for Auto-tracking Ceiling Suspensions. It

allows the Suspension X-ray Tube to track the selected Receptor once it
initiates the movement to change its position.

First of all, both equipment must be properly aligned. The relative distance and
the SID are kept constant. The Receptor is always the Master (the equipment
which initiates the movement), and the Tube of the Suspension is the slave (the
equipment which follows them to get aligned again with the Receptor).

Illustration 4-8
Auto-tracking Ceiling Suspension Control Console

Auto-tracking ON/OFF

The Auto-tracking ON/OFF Led can be:

 GREEN. It means that the Auto-tracking function is allowed.

 RED. It means that the Auto-tracking function is not allowed because the
Tube angle is out of the range 0o ¦2o and 90o ¦2o.

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4.2.3.1 OPERATION WITH ELEVATING TABLES

With the “Auto-tracking ON/OFF” Button OFF:

1. Turn the X-ray Tube to 0o, pointing to the Receptor of the Table.

2. Release manually the brakes and locate the Suspension on Transversal

and Longitudinal Detent position, centered with the Receptor of the
Table.

3. Push once the console “Auto-tracking ON/OFF” button to activate the

Autotracking function.

4. The Suspension will move vertically to reach the default SID distance for
the Auto-tracking function.

5. When the Table, which is always the master equipment, moves up and
down, the Suspension, always the slave equipment, tracks its movement
and moves up or down too, maintaining the same SID.

Illustration 4-9
Auto-tracking Movement Policy for Auto-tracking Ceiling Suspension with Elevating Table

Slave

Master

Lower Raise

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4.2.3.2 OPERATION WITH WALL STAND

With the “Auto-tracking ON/OFF” Button OFF:

1. Turn the X-ray Tube ¦90o pointing to the Receptor of the Wall Stand.

2. Locate the Suspension on Longitudinal and Transversal Detents, at

specific horizontal SID from the Wall Stand.

3. Push once the console “Auto-tracking ON/OFF” Button to activate the

Autotracking function. The Suspension will move vertically to align the
central X-ray beam with the center position of the Wall Stand Receptor,
as Master equipment.

4. When the Wall Stand, which is always the master equipment, moves up
and down, the Suspension, always the slave equipment, tracks its
movement and moves up or down too, maintaining the same SID.

Illustration 4-10
Auto-tracking Movement Policy for Auto-tracking Ceiling Suspension with Wall Stand

Slave

Master

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4.3 RSA MODE

The Standard Ceiling Suspension can operate within RSA Systems as the
secondary suspension. In this case, the Ceiling Suspension operates just in
these mode, so it gets modified in several features, as Detents Points, which
electronics are deactivated, and the Display.

The Auto-tracking Ceiling Suspension can operate within RSA Systems as

the main suspension. In this case, it operates in both available modes, Clinical
and RSA. However, it gets modified in several features, as Detent Points
configuration and the Display.

The Display in RSA Mode is modified in order to get the same lecture in the SID
whichever is the position of the Console. The value of the SID, even the Led
indicator indicates Vertical or Horizontal, is always the Vertical lecture,
indicating the distance to the Receptor in horizontal position.

There are two different positions on the RSA Mode:

 STANDING
 SUPINE

Illustration 4-11
RSA Modes

STANDING SUPINE

1
3
2

4 6

5
7

1 CLINICAL GENERATOR 2 RSA GENERATOR 3 RSA TABLE

4 CLINICAL WALL STAND 5 CLINICAL SUSPENSION

6 RSA DETECTOR 7 RSA SUSPENSION (STANDARD)

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SECTION 5 COLLIMATION

5.1 RALCO AUTOMATIC COLLIMATOR

Note . Refer to the own Collimator Manual for further details and
information about its operation.

Collimator controls consist of the following buttons and knobs:

1 COLLIMATOR DISPLAY 6 CHANGE OF FILTER

2 MANUAL BLADE CONTROL 7 COLLIMATOR LAMP CONTROL (LED ON)

3 AUTOMATIC MODE INDICATOR (GREEN) 8 RETRACTABLE METRIC TAPE

4 BUSY MODE INDICATOR (RED) 9 LASER POINTER WINDOW

5 MANUAL MODE INDICATOR (YELLOW) 10 LASER POINTER ON/OFF BUTTON

Illustration 5-1
Ralco Automatic Collimator

Transverse Field Size Longitudinal Field Size

Manual Blade Control 3 4 5

Source to Image Distance

2 6 7 2

10 9 8

After pressing the Collimator Lamp control, the Lamp remains ON for several
seconds to allow for patient/grid alignment before turning OFF automatically.
An optional Laser positioner may be included with the Collimator Light in order
to facilitate patient positioning.

Exposure field on the Bucky/Detector is adjusted by setting the two knobs. The
table on the Front Panel shows the number to set with the knobs to open the
blades according to the SID and image size to be used.

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The Collimator can rotate ¦90o on its vertical axis while the Tube remains in
the same position. This movement is performed by manually turning the
Collimator and it has detents every 90o.

5.2 RALCO MANUAL COLLIMATOR R225/R225 DHHS

Collimator controls consist of a button to switch on the Collimator lamp and two
knobs to open or close the internal blades of the Collimator.

When pressing the Collimator Lamp push-button, the Collimator light and an
optional Laser light turn on. They remain lighting for 30 seconds before they
switch Off automatically (lighting time can be configured)
.

Exposure field on the Receptor is adjusted by setting the two knobs. The table
on the Front Panel shows the number to set with the knobs to open the blades
according to the SID and X-ray field to be used.

Illustration 5-2
Collimator Controls

Knobs to open or close

the Collimator blades

Collimator Lamp Push-button

The Collimator can rotate ¦90o on its vertical axis while the Tube remains in
the same position. This movement is performed by manually turning the
Collimator and has detents every 90o.

Note . Refer to the corresponding Collimator Manual for extended

information about operation or technical description needed to
maintain compliance with Standard IEC 60601--1--3: 2008.

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5.3 DOSIMETER DEVICE (OPTIONAL)

The optional Dosimeter device is related to the Collimator installed in the

equipment. The usual compatible Dosimeter devices are:

 Vacudap 2000 / 2004 Series

 Iba Kermax Plus
 Diamentor E2 and CI

Note . Refer to the corresponding Dosimeter Manual for extended

information about operation or technical description needed to
maintain compliance with Standard IEC 60601-1-3: 2008.

5.4 X-RAY BEAM ALIGNMENT WITH RESPECT TO PATIENT

After selecting RAD parameters for the technique to be performed:

1. Point the X-Ray Tube-Collimator Assembly to the Image Receptor.

2. Center the Collimator light, which corresponds to the X-Ray beam, with
respect to receptor. For that, use the Collimator Light centering marks
and the laser line on the receptor handle if applicable.

3. Position the patient for the examination.

4. Turn ON the Collimator Lamp and adjust the field size with the Collimator
controls.

5. Perform any adjustment on the patient position, receptor or tube

collimator assembly to assure that the X-Ray beam is correctly
positioned.

ALWAYS SELECT THE CORRECT FIELD SIZE TO AVOID

EXCESSIVE RADIATION.

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THE X-RAY BEAM AXIS AND THE REFERENCE AXIS OF THE

PLANE OF INTEREST COINCIDE AND ARE ORTHOGONAL
WITH RESPECT TO THE PLANE OF INTEREST, IN EXAMS
PERFORMED WITH THE IMAGE RECEPTOR
PERPENDICULARLY POSITIONED WITH RESPECT TO THE
TUBE-COLLIMATOR ASSEMBLY.

IN CASE OF EXAMS WHERE THE IMAGE RECEPTOR IS NOT

PERPENDICULARLY POSITIONED WITH RESPECT TO THE
TUBE-COLLIMATOR ASSEMBLY, THE X-RAY BEAM AXIS
DOES NOT COINCIDE WITH THE REFERENCE AXIS OF THE
PLANE OF INTEREST AND IT IS NOT ORTHOGONAL WITH
RESPECT TO THE PLANE OF INTEREST. THEREFORE, THE
RESULTING IMAGE WILL BE DEFORMED.

IT IS THE OPERATOR/* RESPONSIBILITY THE PROPER

POSITIONING OF THE PATIENT AND EQUIPMENT BEFORE
PERFORMING AN EXAM.

Illustration 5-3
Patient Positioning

Collimator Knobs

Laser Line X-Ray Beam Collimator Light Laser Line

Collimator Knobs

X-Ray Beam Collimator Light

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SECTION 6 TROUBLESHOOTING GUIDE

A guide for a quick solution of main typical problems in the use of this equipment
follows. It is recommended to keep this troubleshooting guide with you when
operating with the equipment.

Table 6-1
Standard and Auto-tracking Ceiling Suspension Error list

PROBLEM CHECK IF ACTION

Check that the Line Power is provided to the

CEILING SUSPENSION CAN NOT BE Ceiling Suspension from the Room Electrical
There is not power enough.
SWITCHED ON Cabinet. If it is correct but it can not be turned ON,
contact Service.

CEILING SUSPENSION ON, Check Control Console Cables

Contact Service.
CONTROL CONSOLE OFF connections.

WRONG DISPLAY MEASURES Wrong calibration. Contact Service.

If the rest of the brakes are not working properly

either, turn the unit OFF and ON. If it still does not
work, contact Service.
Other brakes are working properly.
If the rest of the brakes work properly, contact
BRAKES NOT WORKING PROPERLY Service.

Check that the Line Power is provided to the

Ceiling Suspension from the Room Electrical
There is not power enough.
Cabinet. If it is correct but it can not be turned ON,
contact Service.

If the rest of the Detents are not working properly

either, turn the unit OFF and ON. If it still does not
work, contact Service.
Other Detents are working properly.
If the rest of the Detents work properly, contact
DETENTS NOT WORKING
Service.
PROPERLY
Check that the Line Power is provided to the
Ceiling Suspension from the Room Electrical
There is not power enough.
Cabinet. If it is correct but it can not be turned ON,
contact Service.

LONGITUDINAL MOVING EFFORT If there is still too much effort needed to move the
Longitudinal Brake button is pressed.
TOO HIGH Ceiling Suspension, contact Service.

TRANSVERSAL MOVING EFFORT If there is still too much effort needed to move the
Transversal Brake button is pressed.
TOO HIGH Ceiling Suspension, contact Service.

VERTICAL MOVING EFFORT TOO If there is still too much effort needed to move the
Vertical Brake button is pressed.
HIGH Ceiling Suspension, contact Service.

INCORRECT ALIGNMENT WHEN Turn the X-ray Tube to 0o in the Alpha axis and
X-ray Tube is properly angled.
THE TUBE IS ANGLED angle it again. If it still does not work, call Service.

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Table 6-2
Auto-tracking Ceiling Suspension Error list

PROBLEM CHECK IF ACTION

angle the Tube properly and push the console

Tube angulation is 0o ¦2o. Auto-tracking ON/OFF button to activate the
tracking function.

SUSPENSION DOES NOT MAKE If the Auto-tracking ON/OFF Led is Red, push
TRACKER WITH TABLE once the console Auto-tracking ON/OFF button to
activate the tracking function, led must be Green.
Auto-tracking function is activated.
If the Auto-tracking ON/OFF Led is Green and
Auto-tracking still does not work, call Service.

angle the Tube properly and push the console

Tube angulation is 90o ¦2o. Auto-tracking ON/OFF button to activate the
tracking function.

SUSPENSION DOES NOT MAKE If the Auto-tracking ON/OFF Led is Red, push
TRACKER WITH WALL STAND once the console Auto-tracking ON/OFF button to
activate the tracking function, led must be Green.
Auto-tracking function is activated.
If the Auto-tracking ON/OFF Led is Green and
Auto-tracking still does not work, call Service.

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SECTION 7 PERIODIC MAINTENANCE

In order to assure a continuous and safe performance of the equipment, a

periodic maintenance program must be established. It is the owner’s
responsibility to supply or arrange for this service.

There are two levels of maintenance, the first consists of tasks which are
performed by the user/operator, and the second are those tasks to be
performed by qualified X-ray service personnel.

A periodic maintenance service should be performed every six or twelve (6 or

12) months after installation.

The manufacturer undertakes to have available spare parts for this equipment
for at least ten (10) years after the unit manufacturing.

NEVER ATTEMPT TO PERFORM MAINTENANCE TASKS

WHILE THE EQUIPMENT IS IN USE WITH A PATIENT.

7.1 OPERATOR TASKS

The tasks of this periodic maintenance shall include the following items:

DO NOT REMOVE ANY COVER, DISASSEMBLE OR

MANIPULATE INTERNAL COMPONENTS OF THE
EQUIPMENT. THESE ACTIONS COULD CAUSE SERIOUS
PERSONAL INJURIES AND / OR EQUIPMENT DAMAGE.

NEVER ATTEMPT TO CLEAN ANY EQUIPMENT PART WHEN

IT IS SWITCHED ON. ALWAYS SWITCH OFF THE SYSTEM
BEFORE CLEANING AND ISOLATE THE MAINS
ELECTRICAL SUPPLY BEFORE CLEANING.

1. Switch the system OFF.

2. Externally check the proper cable connections between each major

component in the X-Ray System.

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3. Clean the equipment frequently, particularly if corroding chemicals are

present. Clean external covers and surfaces, especially parts in contact
with patients, with a cloth moistened in warm water with mild soap. Wipe
with a cloth moistened in clean water. Do not use cleaners or solvents
of any kind.

7.2 SERVICE TASKS

Only service personnel specifically trained on this medical X-ray equipment

should work on service tasks (installation, calibration or maintenance) of the
equipment. (Refer to the respective chapters of the Service Manual provided
with this equipment.)

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SECTION 8 TECHNICAL SPECIFICATIONS

This section provides product information and illustrations showing physical

dimensions, weight and general requirements for normal operation.

POWER LINE REQUIREMENTS

Power Line for Ceiling Suspension:

Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 -- 240 V~
Maximum Current . . . . . . . . . . . . . . . . . . . . . . 3.5 -- 1.6 A
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 / 60 Hz
Input Power . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 kVA

Power line for Collimator Lamp 24 VAC,

6.5 A
50 / 60 Hz

OPERATING ENVIRONMENTAL CONDITIONS

Temperature range . . . . . . . . . . . . . . . . . . . . . . . . . . 10 oC to 40 oC
Relative Humidity range (non-condensing) . . . . . . 20% to 85%
Atmospheric Pressure range ................ 700 to 1060 hPa

STORAGE / TRANSPORT ENVIRONMENTAL CONDITIONS

Temperature range . . . . . . . . . . . . . . . . . . . . . . . . . . --20 oC to 70 oC

Relative Humidity range (non-condensing) . . . . . . 10% to 95%

Atmospheric Pressure range . . . . . . . . . . . . . . . . . . 500 to 1060 hPa

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PRODUCT CHARACTERISTICS

 Dimensions

G Maximum Height . . . . . . . . . . . . . . . . . . . . . . . 2641 mm (103.98”)

G Minimum Height . . . . . . . . . . . . . . . . . . . . . . . . 1068 mm (42.05”)

G Width . . . . . . . . . . . . . . . . . . . . . . . . . . . 3500 mm (137.80”) Max

G Length . . . . . . . . . . . . . . . . . . . . . . . . . . 6000 mm (236.22”) Max

 Distance between Longitudinal Rails . . . . . . . . . . . . 1432 +5/--15 mm

(56.38” +0.2/--0.6)

 Weights

G Main assembly and Control Console . . . . . . 230 kg (507.06 lb)

G Longitudinal and Transversal Rails . . . . 85 kg (187.39 lb) Max

G X-ray Tube, Collimator, Hose and cables . . 80 kg (176.37 lb)

 Travels

G Longitudinal travel . . . . . . . . . . . . . . . . 4866 mm (191.6”) Max

G Transversal travel . . . . . . . . . . . . . . . . 1901 mm (74.84”) Max

G Vertical travel . . . . . . . . . . . . . . . . . . . . . . . . . . 1570 mm (61.81”)

 X-ray Tube rotation (Beta Axis) . . . . . . . . . . . . . . . . . . . . . . ±180o

 X-ray Tube angulation (Alpha Axis) . . . . . . . . . . . . . . . . . . . ±135o

 Maximum and Minimum SID from X-ray Tube facing the Table and Wall
Stand depends on the Room dimensions and longitudinal Rails of the
unit.

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Illustration 8-1
Dimensions and Travels

Length of Longitudinal Rails:

6000 (232.22”), 5340 (210.22”), 4679 (184.22”), 4019 (158.22”) & 3358 mm (132.22”
)

737 mm (29”)

1071 mm (42.17”)

2700 mm (106.3”) -- minimum recommended height

Longitudinal Rails
2307 mm (90.83”)

2641 mm (104”)
1570 mm (61.8”)

1570 mm (61.8”)
Focal spot

±135o
(Alpha

angulation)

Length of Transversal Rails:

3500 (137.80”), 3000 (118.11”), 2750 (108.27”), 2500 (98.42”), 2250 (88.58”) & 2000 mm (78.74”)
Column Center
737 mm (29”)

Transversal Rails
2307 mm (90.83”)

1570 mm (61.8”)

Focal spot
282 mm (11”)

±180o
(Beta rotation)

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Table 8-1
Rails Dimensions and Carriage Travels

Distance from the column’s center

Lo git di al Rails Le
Longitudinal Length
gth Carriage Travel
Tra el
To the Left To the Right

3358 mm (132.22”) 2224 mm (87.57”)

4019 mm (158.22”) 2885 mm (113.57”)

405 mm (min) 729 mm (min)
4679 mm (184.22”) 3545 mm (139.57”)
15 94” (min)
15.94” 28 70” (min)
28.70”
5340 mm (210.22”) 4206 mm (165.57”)

6000 mm (236.22”) 4866 mm (191.57”)

Distance from the column’s center

Tra s ersal Rails Length
Transversal Le gth Carriage Travel
Tra el
To the Front To the Back

2000 mm (78.74”) 901 mm (35.4”)

2250 mm (88.58”) 1151 mm (45.3”)

2500 mm (98.42”) 1401 mm (55.1”)

762 mm (min) 343 mm (min)
2750 mm (108.27”) 1651 mm (65”) 30” (min) 13.50”(min)

3000 mm (118.11”) 1901 mm (74.8”)

3500 mm (137.80”) 2401 mm (94.5”)

Illustration 8-2
Focal Spot Travel
565 mm
(22.24”)

115 mm
(4.52”)

Focal spot
984 mm
(38.74”)
534 mm
(21”)

687 mm (27”) 1011 mm (39.8”)

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Illustration 8-3
Rails Dimensions and Travels
3500 (137.80”), 3000 (118.11”), 2750 (108.27”), 2500 (98.42”), 2250 (88.58”) & 2000 mm (78.74”)

100 mm (min.)
66 mm (min.)
622 mm

622 mm
(24.48”)
Cable rail
24.48”

(3.93”)
(2.59”)

A
D

660.4 mm
(260”)
Length of Transversal Rails:

56.38”(+0.21 --0.6)
1432 mm (+5 --15)
Transversal rails Longitudinal rails

28.2 mm
28.2 mm
(11.1”)
(11.1”)

477 mm
(18.77”)
477 mm

Focal spot
(18.77”)

180 mm (7”) 954 mm (37.55”)

Length of Longitudinal Rails:
6000 (232.22”), 5340 (210.22”), 4679 (184.22”), 4019 (158.22”) & 3358 mm (132.22”
)

Table 8-2
Distances between Longitudinal rail and transversal and cable rails

Tra s ersal Rails Length

Transversal Le gth D A

2000 mm (78.74”) 284 mm (11.18”) 330 mm (12.99”)

2250 mm (88.58”) 409 mm (16.10”) 455 mm (17.91”)

2500 mm (98.42”) 534 mm (21.02”) 580 mm (22.83”)

2750 mm (108.27”) 659 mm (25.94”) 705 mm (27.75”)

3000 mm (118.11”) 784 mm (30.87”) 830 mm (32.68”)

3500 mm (137.80”) 1034 mm (40.71”) 1080 mm (42.52”)

D = (Length of transversal rail -- 1432 mm [56.38”]) / 2

A = D + 46 mm

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APPENDIX A GUIDELINES FOR PEDIATRIC

APPLICATIONS

Children are more radiosensitive than adults. Adopting the

Image Gently campaign guidelines and reducing dose for
radiographic procedures while maintaining acceptable
clinical image quality will benefit patients.

Please review the following link and reduce pediatric technique factors
accordingly: http://www.pedrad.org/associations/5364/ig/

As a general rule, next recommendations shall be observed in pediatrics:

 X-Ray Generator must have short exposures times.

 AEC must be used carefully, preferably use manual technique setting,

applying lower doses.

 If possible, use high kVp techniques.

Positioning the pediatric patient: Pediatric patients are not as likely as adults
to understand the need to remain still during the procedure. Therefore it makes
sense to provide aids to maintaining stable positioning. It is strongly
recommended the use of immobilizing devices such as bean bags and
restraint systems (foam wedges, adhesive tapes, etc.) to avoid the need of
repeating exposures due to the movement of the pediatric patients. Whenever
possible use techniques based on the lowest exposure times.

Shielding: We recommend you provide extra shielding of radiosensitive

organs or tissues such as eyes, gonads and thyroid glands. Applying a
correct collimation will help to protect the patient against excessive radiation as
well. Please review the following scientific literature regarding pediatric
radiosensitivity: GROSSMAN, Herman. “Radiation Protection in Diagnostic
Radiography of Children”. Pediatric Radiology, Vol. 51, (No. 1): 141--144,
January, 1973: http://pediatrics.aappublications.org/cgi/reprint/51/1/141.

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Technique factors: You should take steps to reduce technique factors to the
lowest possible levels consistent with good image acquisition.

For example if your adult abdomen settings are: 70--85 kVp, 200--400 mA,
15--80 mAs, consider starting at 65--75 kVp, 100--160 mA, 2.5--10 mAs for a
pediatric patient. Whenever possible use high kVp techniques and large SID
(Source Image Distance).

Summary:

 Image only when there is a clear medical benefit.

 Image only the indicated area.

 Use the lowest amount of radiation for adequate imaging based on size
of the child (reducing tube output -- kVp and mAs).

 Try to use always short exposure times, large SID values and
immobilizing devices.

 Avoid multiple scans and use alternative diagnostic studies (such as

ultrasound or MRI) when possible.

A-2 OM-0527R5