Operator Manual
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Technical Publications 5764871--1EN Revision 4
Radiographic System: Proteus XR/f ET Operator Manual
do not duplicate
WARNING THIS EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED Though this equipment is built to the highest standards of electrical and mechanical safety, the useful radiation beam becomes a source of danger in the hands of the unauthorized or unqualified operator. Excessive exposure to radiation causes damage to human tissue. Therefore, adequate precautions must be taken to prevent unauthorized or unqualified persons from operating this equipment or exposing themselves or others to its radiation. Before operation, persons qualified and authorized to operate this equipment should be familiar with the Recommendations of the International Commission on Radiological Protection, contained in Annals Number 60 of the ICRP, with applicable National Standards, and should have been trained in use of the equipment.
ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM This equipment or system contains environmentally dangerous components and materials (such as PCB‘s, electronic components, used dielectric oil, lead, batteries etc.) which, once the life-cycle of the equipment or system comes to an end, becomes dangerous and need to be considered as harmful waste according to the international, domestic and local regulations. The manufacturer recommends to contact an authorized representative of the manufacturer or an authorized waste management company once the life-cycle of the equipment or system comes to an end to remove this equipment or system.
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OM 5764871--1EN
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 1
2
Page INTRODUCTION...
9
1.1
General Features...
11
1.2
Product Identification...
13
1.3
Indications for Use...
14
1.4
Applied Parts...
15
SAFETY AND REGULATORY INFORMATION...
17
2.1
General...
17
2.2
Responsibilities...
20
2.3
Maximum Permissible Dose (MPD)...
21
2.4
Radiation Protection...
22
2.5
Monitoring of Personnel...
24
2.6
Safety Symbols...
25
2.7
Regulatory Information...
30
2.7.1
Certifications...
30
2.7.2
Environmental Statement on the Cycle of the Equipment or System
30
2.7.3
Mode of Operation...
30
2.7.4
Protection against Electric Shock Hazards...
31
2.7.5
Protection against Harmful Ingress of Water or Particulate Matter . . .
31
2.7.6
Protection against Hazards of Ignition of Flammable Mixtures...
31
2.7.7
Protection against Hazards from Unwanted or Excessive Radiation .
31
2.7.8
Designated Significant Zones of Occupancy...
32
2.7.9
Distribution of Stray Radiation...
35
2.8
Electromagnetic Compatibility (EMC)...
38
2.9
Quantitative Information...
46
2.9.1
Functional Tests Performed to Obtain the Quantitative Information . .
46
2.10 Deterministic Effects...
53
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Section 3
4
5
Page START UP AND SHUTDOWN...
55
3.1
Start up with X-Ray Generator Control...
55
3.2
Shutdown Routine with X-Ray Generator Control...
57
X-RAY GENERATOR CONTROL...
59
4.1
Power ON / OFF...
60
4.2
Exposure Controls...
60
OPERATION...
63
5.1
Floor Mounted Tube Stand...
64
5.1.1
Column Rotation Control...
64
5.1.2
ET Control Panel...
65
5.2
Ralco Manual Collimator R225/R225 DHHS...
67
5.3
Dosemeter Device (optional)...
68
5.4
Elevating Table...
68
5.4.1
Portable Receptor Assembly for Table...
71
5.4.1.1 Portable Receptor Assembly with non-Rotating Tray...
71
5.4.1.2 Portable Receptor Assembly with Rotating Tray...
73
5.4.2
Hand Grips (optional)...
74
5.4.3
Compression Band (optional)...
75
5.4.4
Lateral Detector Holder (optional)...
76
5.4.5
Lateral Detector Holder on Table (optional)...
77
5.4.6
Lateral Detector Holder with Trolley (optional)...
78
Wall Stand...
81
5.5.1
Portable Receptor Assembly for Wall Stand...
82
5.5.1.1 Portable Receptor Assembly with non-Rotating Tray...
83
5.5.1.2 Portable Receptor Assembly with Rotating Tray...
84
5.5.2
Arm Support (optional)...
88
5.5.3
Hand Grips for Wall Stand (optional)...
88
5.6
Mechanical Tracking of Table Receptor (optional)...
89
5.7
Grids...
91
5.8
X-Ray Beam Alignment with Respect to Patient...
92
5.5
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Section 6
7
8
9
Page ERROR CODES...
95
6.1
Generator Error Codes...
95
6.2
System Error Codes in the Digital Control Panel...
98
OPERATING SEQUENCES...
99
7.1
Start-up Routine...
99
7.2
X-ray Tube Warm-up Procedure...
99
7.3
Radiographic Operation...
100
7.4
AEC Operation...
101
7.4.1
AEC Rapid Termination...
101
7.4.2
How to Verify the Proper Functioning of the Automatic Exposure Control...
102
7.5
Using and Maintaining the Digital Detector...
103
7.6
Guidelines for Pediatric Applications...
104
PERIODIC MAINTENANCE...
107
8.1
Operator Tasks...
107
8.2
Service Tasks...
108
TECHNICAL SPECIFICATIONS...
109
9.1
Environmental Conditions...
109
9.2
Positioners...
109
9.2.1
Power Line Requirements...
109
9.2.2
Information Related to Radiation...
110
9.2.3
Physical Characteristics...
110
X-Ray Generator...
115
9.3.1
Factors...
115
9.3.2
Range of Radiographic Parameters...
115
9.3.3
Duty Cycle...
116
9.3.4
Physical Characteristics...
116
X-Ray Tubes...
117
9.3
9.4
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Section
Page REVISION HISTORY...
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OM 5764871--1EN
SECTION 1
INTRODUCTION This manual contains all the necessary information to understand and operate the Proteus XR/f ET System. It provides a general description, safety information, operating instructions and specifications concerning the equipment. This manual is not intended to teach radiology or to make any type of clinical diagnosis. The Tube Support Column, the Elevating Table and the Wall Stand are associated equipment to the X-ray Generator Unit. Basically, the System consists of the following associated subassemblies: Tube Support with variable height, X-ray Tube, Collimator, Elevating Table and Wall Stand. The Elevating Table and the Wall Stand house a Digital Detector (Digital Radiography). The Control Panel is ergonomically built, equipped with logically arranged and easily accessible controls. Column movements are driven by the Control Panel hand-grips. Brakes are released by a slight thumb pressure on the control push-buttons.
Illustration 1 Radiographic Room Positioners
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The Generator Cabinet comprises the Power Module (which contains the power and control components) and the High Voltage Transformer. The operator controls and displays for radiographic operations are shown on one of the Screen Console of the Image Acquisition Workstation. All functions, displays and controls are logically arranged, easily accessible and identified to prevent confusion. Technique factors and functions are selected by pushing the corresponding buttons or by touching directly on the screen, as applicable. The Image Acquisition Workstation is used for imaging processing and diagnosis in Digital Radiography Systems. The High Frequency X-ray Generator provides all the advantages of high frequency waveform Generators including lower patient dose, shorter exposure times and greater accuracy and consistency. The Generator is controlled by multiple microprocessors providing increased exposure consistency, efficient operation and extended Tube life. A high level of self-diagnosis greatly increases serviceability and reduces down time.
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1.1
GENERAL FEATURES The main features of the Radiographic Room are:
A solid and ergonomic design.
Easy operation, security and precision of all positioning movements with respect to patient.
Movement Controls for each component of the Radiographic Room.
Specific System Configurations are detailed in the following table:
FLOOR MOUNTED TUBE STAND Control Panel
Digital
Autodiagnostics
n
Horizontal Motion of Column (Configurable Detents)
Manual (3)
Vertical Motion of Arm
Manual
Rotation of the Column on its Vertical Axis (Detents)
Manual ±180o (--180o, --90o, 0o, +90o, +180o)
Rotation of the Tube-Collimator Assembly on its Transverse Axis (Detents)
Manual ±150o (Angle Readout) (--90o, 0o, +90o)
Transverse Motion of Tube-Collimator Assembly
Manual with Centering Detent
SID Readout respect to Table
Continuous
SID Readout respect to Wall Stand
on three (3) configured positions
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ELEVATING TABLE Digital Detector Assembly with Longitudinal Motion
n
Ion Chamber Connection
n
WALL STAND Digital Detector Assembly Adjusted with Internal Counterweights
n
Ion Chamber Connection
n
Right or Left Film Loading (as per customer order)
n OPTIONS
Table Receptor Centering (mechanical link with the Tube Stand Column)
n
Dosemeter Device
n ACCESSORIES
Hand Grips for Elevating Table Tabletop
n
Compression Band for Elevating Table
n
Lateral Detector Holder
n
Table Top Lateral Detector Holder
n
Lateral Detector Holder with trolley
n
Arm Support for Wall Stand
n
Hand Grips for Wall Stand
n
Note .
The Handgrips must not be positioned in the trajectory of the X-Ray beam.
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Proteus XR/f ET
REV 4
OM 5764871--1EN
1.2
PRODUCT IDENTIFICATION The major items in the Radiographic Room have some identification labels attached to them which provide the following manufacturer and product information.
Product.
Model.
Volts (V), Line Phases, Frequency (Hz), and Power (kVA, kW).
Date of manufacture.
Serial number.
Reference.
Manufacturer.
Place of manufacture.
Certification.
RAD Room Label
Product Labels Product Labels Product Labels
Note .
For further information on the standardized symbology of this labels, refer to Section 2.
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1.3
INDICATIONS FOR USE In accordance with FDA 510(k): The Proteus XR/f ET Radiographic Systems with Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
In accordance with IEC Standards: INTENDED USE This equipment is intended for medical prescription use by qualified personnel only. The Proteus XR/f ET Radiographic System is an equipment 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 for diagnostic purposes. 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 abled, disabled, immobilized or shocked. This Proteus XR/f ET Radiographic System contributes to the metrics of imaging performance ensuring the efficient use of radiation. As example of X-ray image receptors types that can be used: Digital Detectors. NORMAL USE The Normal Use of this equipment is defined as the Intended Use plus the Maintenance and Service tasks.
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 specifically designed for paediatric purposes; if children are to be examined, they should always be accompanied by an adult.
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1.4
APPLIED PARTS Applied Parts refer to parts of medical equipment that in Normal Use necessarily comes into physical contact with the patient for medical equipment to perform its function. This RAD equipment includes the following Applied Parts:
Tabletop of the RAD Table.
Tabletop of the RAD Wall Stand.
Hand Grips (optional).
Arm Support (optional).
Compression Band (optional).
Lateral Detector Holders (optional).
Other accessories.
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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 information 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, REGULATIONS, 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 IEC 60601-2-54:2009
ITEM 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 panel of DIGITAL X-RAY IMAGING DEVICE
1.2
1.2
Cradle
2.3
2.3
PATIENT SUPPORT, stationary, without articulated joints
1.2
1.2
PATIENT SUPPORT, movable, without articulated joints (including stationary layers)
1.7
1.7
PATIENT SUPPORT, with radiolucent panel having one articulated joint
1.7
1.7
PATIENT SUPPORT, with radiolucent panel having two or more articulated joints
2.3
2.3
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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