1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA XR 24-2008 (R2014)Primary User Controls for Interventional Angiography X-Ray EquipmentNEMA XR 24-2008 (R2014) Primary User Controls for Interventional Angiography X-Ray Equipment Published by: National Electrical Manufacture
2、rs Association 1300 North 17th Street, Suite 900 Rosslyn, Virginia 22209 Hwww.nema.orgH Hwww.medicalimaging.orgH 2014 National Electrical Manufacturers Association. All rights, including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the
3、 Protection of Literary and Artistic Works, and the International and Pan American copyright conventions. 2014 National Electrical Manufacturers Association NOTICE AND DISCLAIMER The information in this publication was considered technically sound by a consensus among persons engaged in its developm
4、ent at the time it was approved. Consensus does not necessarily mean there was unanimous agreement among every person participating in the development process. The National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document herein is one, are deve
5、loped through a voluntary standards development process. This process brings together volunteers and/or seeks out the views of persons who have an interest in the topic covered by this publication. Although NEMA administers the process and establishes rules to promote fairness in the development of
6、consensus, it does not write the documents, nor does it independently test, evaluate, or verify the accuracy or completeness of any information or the soundness of any judgments contained in its standards and guideline publications. NEMA disclaims liability for any personal injury, property, or othe
7、r damages of any nature, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of an
8、y information published herein, and disclaims and makes no warranty that the information in this document will fulfill any particular purpose(s) or need(s). NEMA does not undertake to guarantee the performance of any individual manufacturers or sellers products or services by virtue of this standard
9、 or guide. In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on
10、his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstance. Information and other standards on the topic covered by this publication may be available from other sources, which the user m
11、ay wish to consult for additional views or information not covered by this publication. NEMA has no power, nor does it undertake to police or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purpos
12、es. Any certification or other statement of compliance with any health- or safety-related information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement. XR 24-2008 (R2014) Page i 2014 National Electrical Manufacturers Assoc
13、iation TABLE OF CONTENTS Foreword ii Member Company List 1 History . 1 Section 1 OVERVIEW . 2 1.1 Scope . 2 1.2 Rationale 2 1.3 References 2 1.3.1 Normative References. 2 1.3.2 Informational References 3 1.4 Definitions 3 1.5 Abbreviations And Acronyms . 3 Section 2 PRIMARY CONTROLS AND FUNCTIONS 4
14、2.1 Collimator control . 4 2.2 Footswitch pedals controlling fluoroscopy and exposure 6 2.3 Detector Field Size. 6 2.4 C-arm . 7 2.5 Table Top Movement . 11 Appendix A . 12 XR 24-2008 (R2014) Page ii 2014 National Electrical Manufacturers Association Foreword This standard is intended to be used by
15、manufacturers in the design of Interventional X-Ray Equipment. The members of the standard writing committee have reviewed the draft of this standard, in personal interviews, with users of this equipment: interventional radiologists, neuro-radiologists, and cardiologists. This standard was developed
16、 by the Cardiovascular and Interventional Group of the X-Ray Imaging Section of the Medical Imaging the manufacturers are constantly improving the subject equipment in the interest of better usability. Therefore, suggesting limiting any function to a single device would freeze technology and could b
17、e an obstacle to progress. Todays controls may be replaced by new (image guided, etc.) concepts of controls in the near future. The IEC usability standard, IEC 60601-1-6, doesnt contain equipment-specific details for primary tableside controls. This NEMA standard supplements the principles of this I
18、EC standard. 1.3 REFERENCES 1.3.1 Normative References The following normative documents contain provisions, which through reference in this text constitute provisions of this Standards Publication. By reference herein these publications are adopted, in whole or in part as indicated, in this Standar
19、ds Publication. International Electrotechnical Commission/ International Organization for Standardization (IEC/ISO) 3, rue de Varembe Case postale 131 CH-1211 Geneva 20 IEC 60878 Graphical Symbols for Electrical Equipment in Medical Practice IEC 60417 Graphical Symbols for Use on Equipment XR 24-200
20、8 (R2014) Page 3 2014 National Electrical Manufacturers Association 1.3.2 Informational References International Electrotechnical Commission/ International Organization for Standardization (IEC/ISO) 3, rue de Varembe Case postale 131 CH-1211 Geneva 20 IEC 60601-1-6 Medical Electrical EquipmentPart 1
21、-6General Requirements for Basic Safety and Essential PerformanceCollateral standard: Usability 1.4 DEFINITIONS interventional X-Ray equipment: Used in catheterization laboratories for interventional procedures Consist of a C-arm and an interventional table with a floating table top primary user con
22、trol functions: most frequently used during a procedure critical for radiation safety of patients and operators critical for mechanical safety of patients system movement, collision primary user control functions for monoplane interventional X-Ray equipment: Collimator blade movements Field size adj
23、ustment Performing fluoroscopy Performing acquisition/exposure C-arm motion Table top horizontal and transversal motions fluoroscopy: A low dose X-Ray technique where live pictures appear on a screen instead of taking a permanent picture (some manufacturers allow recording those images). Used while
24、a procedure is being performed to monitor its progress. Sometimes also referred to as radioscopy. exposure: A standard dose X-Ray technique where images are made permanent by recording them; the live pictures also appear on a screen. The images can be single images or movies. Used while a procedure
25、is being performed, for the purpose of documentation. Sometimes also referred to as radiography or acquisition. 1.5 ABBREVIATIONS AND ACRONYMS LAO left anterior oblique RAO right anterior oblique SID Source to Image Distance XR 24-2008 (R2014) Page 4 2014 National Electrical Manufacturers Associatio
26、n Section 2 PRIMARY CONTROLS AND FUNCTIONS At the time of the writing of this standard, the controls made by different vendors are functioning differently. This is due to and is the result of sustained preferences of different groups of users. Therefore, to accommodate users with unique requirements
27、, it is expected that manufacturers make controls configurable for alternate operating modes from those described below. Such unique requirements may arise because of experience with a certain behavior of controls. For example: practitioners with only one brand of equipment may not be interested in
28、changing (for the reason of standardization) the operation of their systems. The user controls on interventional X-Ray equipment are permanently labeled per international safety standards (IEC 60601-1, Ed2: subclauses 6.1 and 6.3b, Ed3: subclauses 7.1.3, 7.4.2). For this reason, the reconfiguration
29、of controls by users is not practical and may create labeling issues, unless appropriate compliance tests are performed in order to certify that the reconfiguration is effective, and that objective evidence is recorded and maintained by the user, which may then be considered as assembler of certifie
30、d components (as defined in 21CFR 1020.30(d); such a process is not considered as being practical for users. This standard recommends controls for the functions as described below. 2.1 COLLIMATOR CONTROL This section addresses the vertical and horizontal collimator shutter position controls. This st
31、andard also only applies to the symmetrical motion of the horizontal and vertical collimator blades. The concept is applied that if similar controls are used for similar control function, the operation is to be identical. The most common way to adjust the rectangular collimator today is the usage of
32、 a joystick. If a joystick is employed for collimator control it shall operate as follows (Figure 2-1) in regard to the image on the monitor: XR 24-2008 (R2014) Page 5 2014 National Electrical Manufacturers Association Movement on monitor Joystick control Opens the horizontal collimator blades Joyst
33、ick up Closes the horizontal collimator blades Joystick down Closes the vertical collimator blades Joystick left Opens the vertical collimator blades Joystick right Figure 2-1 JOYSTICK OPERATION OF THE RECTANGULAR COLLIMATOR The reset functionality can either be integrated in the joystick, or be rea
34、lized as a separate button. The symbols used to indicate the functionality shall be substantially equivalent to the IEC symbols for rectangular collimators (IEC 60878/ IEC 60417, nos. 5385, 5386, 5387, 5388). The symbols to be used in the vicinity of joystick for the rectangular collimation are indi
35、cated below (Figure 2-2): Figure 2-2 SYMBOLS TO BE USED IN THE VICINITY OF JOYSTICK FOR THE RECTANGULAR COLLIMATION XR 24-2008 (R2014) Page 6 2014 National Electrical Manufacturers Association 2.2 FOOTSWITCH PEDALS CONTROLLING FLUOROSCOPY AND EXPOSURE This section addresses the footswitch controllin
36、g fluoroscopy and exposure. The default configuration shall be: fluoroscopyleftmost pedal (on when pressed) exposurethe exposure pedal shall be clearly distinguished from the fluoroscopy pedal; for example, designing an elevated exposure pedal (Figure 2-3); integrating a divider between fluoroscopy
37、and exposure pedals, etc. The symbols used to indicate the functionality shall be substantially equivalent to the IEC symbols for fluoroscopy and exposure (IEC 60878/IEC 60417, nos. 5330, 5329). Figure 2-3 EXAMPLE FOR LAYOUT OF FLUOROSCOPY AND EXPOSURE ON A 3-PEDAL FOOTSWITCH AND SYMBOLS TO BE USEDT
38、HE OTHER PEDAL(S) ARE USED FOR FUNCTIONALITIES NOT ADDRESSED IN THIS DOCUMENT 2.3 DETECTOR FIELD SIZE This section addresses the control of the detector field size. The concept is applied that if similar controls are used for similar control function, the operation is to be identical. The most commo
39、n way to control the detector field size is the usage of a dual button with a horizontal orientation. If a dual button is used, pressing the left button shall increase the detector field size (decrease zoom), pressing the right button shall decrease the detector field size (increase zoom). The symbo
40、l(s) to be used to indicate the functionality shall be substantially equivalent to the IEC symbols for the X-Ray image intensifier input field (see Fig. 2-4). Figure 2-4 SYMBOLS TO BE USED IN THE VICINITY OF CONTROL FOR THE FIELD SIZE (IEC 60878/IEC 60417, NOS. 5378, 5642, 5379). XR 24-2008 (R2014)
41、Page 7 2014 National Electrical Manufacturers Association 2.4 C-ARM This standard addresses the control of the C-arm. The concept is applied that if similar controls are used for similar control functions, the operation is to be identical. The most common way to control the C-arm movements is a joys
42、tick or a handle. If a joystick or a handle is used, the movement of the joystick or the handle shall cause and reflect the physical C-arm movement regardless on which side of the table the control is mounted. When the tableside user interface is located at the right side of the table, joystick used
43、 to control the C-arm motion shall operate as follows (Figures 2-5 and 2-6): Fig. 5: Joystick and handle cranial and caudal movement of the C-arm when the controls are mounted on the doctors side of the table Figure 2-5 JOYSTICK AND HANDLE CRANIAL AND CAUDAL MOVEMENT OF THE C-ARM WHEN THE CONTROLS A
44、RE MOUNTED ON THE RIGHT SIDE OF THE TABLE Caudal movement move right Controls on right side of the table Cranial movement move left turn counter clockwise turn clockwise joystick handle handle XR 24-2008 (R2014) Page 8 2014 National Electrical Manufacturers Association Figure 2-6 JOYSTICK AND HANDLE
45、 LAO AND RAO MOVEMENT OF THE C-ARM WHEN THE CONTROLS ARE MOUNTED ON THE RIGHT SIDE OF THE TABLE move up move down joystick handle Controls on right side of the table LAO movement RAO movement selection button + tilt up selection button + tilt down XR 24-2008 (R2014) Page 9 2014 National Electrical M
46、anufacturers Association When the tableside user interface is located at the left side of the table, joystick used to control the C-arm motion shall operate as follows (Figures 2-7 and 2-8): Figure 2-7 JOYSTICK AND HANDLE CRANIAL AND CAUDAL MOVEMENT OF THE C-ARM WHEN THE CONTROLS ARE MOUNTED ON THE
47、LEFT SIDE OF THE TABLE Caudal movement move left Controls on left side of the table Cranial movement move right turn clockwise turn counter clockwise joystick handle XR 24-2008 (R2014) Page 10 2014 National Electrical Manufacturers Association Figure 2-8 JOYSTICK AND HANDLE LAO AND RAO MOVEMENT OF T
48、HE C-ARM WHEN THE CONTROLS ARE MOUNTED ON THE LEFT SIDE OF THE TABLE The symbol used to indicate the functionality shall be substantially equivalent to the IEC symbol for the C-arm (IEC 60878/IEC 60417, no. 5373). move down move up joystick handle Controls on left side of the table LAO movement RAO
49、movement selection button+tilt selection button+tilt upuupdown XR 24-2008 (R2014) Page 11 2014 National Electrical Manufacturers Association 2.5 TABLE TOP MOVEMENT This section addresses the control of the floating table top longitudinal and transversal movement. The concept is applied that if similar controls are used for similar control functions, the operation is to be identical. The two common ways of controlling the floating table top movement are: mushroom-shaped handles and handgrip-shaped handles. Mushroom-shaped han
