IEC 63045:2020 is applicable to \u2013 therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses; \u2013 therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy, where the pressure pulses are released as single events of duration up to 25 \u00b5s. This document does not apply to \u2013 therapy equipment using focusing pressure pulse sources such as extracorporeal lithotripsy equipment; \u2013 therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU\/HITU equipment. This document specifies \u2013 measurable parameters which are used in the declaration of the acoustic output of extracorporeal equipment producing a non-focused or weakly focused pressure pulse field, \u2013 methods of measurement and characterization of non-focused or weakly focused pressure pulse fields. This document has been developed for equipment intended for use in pressure pulse therapy, for example therapy of orthopaedic pain like shoulder pain, tennis elbow pain, heel spur pain, muscular trigger point therapy, lower back pain, etc. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689) and HIFU\/HITU equipment (see IEC 60601 2-62 and IEC TR 62649).<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | CONTENTS <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 4 List of symbols <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5 Conditions of measurement 5.1 General 5.2 Measurements in the water test chamber 5.3 Measurements in the dry test bench 6 Test equipment 6.1 Water test chamber <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 6.1.1 Coordinate system 6.1.2 Hydrophone for water test chamber measurements 6.1.3 Hydrophone for pressure pulse measurements <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.2 Dry test bench 6.3 Voltage measurement 6.3.1 Oscilloscope or transient recorder <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 6.3.2 Pressure pulse waveform recording 7 Measurement procedure Figures Figure 1 \u2013 Typical pressure pulse waveform at 2 mm distancefrom a ballistic pressure pulse source <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 7.1 Measurement procedure in the water test chamber 7.1.1 General 7.1.2 Spatial measurements <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Figure 2 \u2013 Typical pressure distribution along the beamaxis of a non-focusing pressure pulse source <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 7.1.3 Non-focusing source Figure 3 \u2013 Typical pressure distribution along the beam axisof a weakly focusing pressure pulse source <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 7.1.4 Weakly focusing source 7.1.5 Beam plots of peak-positive acoustic pressure 7.1.6 Beam plots of peak-negative acoustic pressure <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 7.1.7 Measurement centre point and beam axis 7.1.8 Beam width measurements Figure 4 \u2013 Typical lateral pressure distributions of pc at the beampressure maximum of two ballistic pressure pulse sources <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 7.1.9 Beam pressure maximum extent measurements 7.1.10 Beam cross-sectional area and beam pressure maximum cross-sectional area 7.1.11 Beam pressure maximum volume measurements 7.1.12 Beam volume 7.2 Temporal measurements <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 7.3 Acoustic energy measurements 7.3.1 General 7.3.2 Pulse-pressure-squared integral 7.3.3 Derived pulse-intensity integral 7.3.4 Derived beam \u2212n dB pressure maximum acoustic pulse energy <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 7.3.5 Derived acoustic pulse energy 7.4 Dry test bench measurements <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Annex A (informative) Acoustic pressure pulse therapy A.1 Background A.1.1 General A.1.2 Development of relevant measurement standard A.1.3 Current knowledge on biomedical effects A.1.4 Availability of clinical and technical data <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | A.2 Other treatment devices and methods not subject to this document A.2.1 Percutaneous continuous and modulated wave systems A.2.2 Extracorporeal shock wave lithotripsy A.2.3 Further exclusions <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Annex B (informative)Types of pressure pulse transducers B.1 Overview B.1.1 General B.1.2 Principle of ballistic pressure pulse sources B.1.3 Rail gun principle <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | B.1.4 Further generation principles B.2 Non-focusing and focusing transducers <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | B.3 Examples of pressure pulse sources and their parameter sets <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Figure B.1 \u2013 Applicator directly coupled to the patient Figure B.2 \u2013 Pressure pulse source, non-symmetric (linear),directly coupled to the patient <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Figure B.3 \u2013 Pressure pulse source, symmetric, distant from the patient Figure B.4 \u2013 Applicatorcoupled to patient Figure B.5 \u2013 Non-focusedpressure pulse field <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Figure B.6 \u2013 Non-focused pressure pulse field -n dB parameters (example: n = 6) Figure B.7 \u2013 Non-focused pressure pulse field isobars <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Figure B.8 \u2013 Weakly-focused pressure pulse field \u22126 dB contour and parameters Figure B.9 \u2013 Weakly-focused pressure pulse field volume and isobar parameters <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | B.4 Positioning and targeting methods Figure B.10 \u2013 Weakly-focused pressure pulse field parameters <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Annex C (informative)Field measurement C.1 Measurement probes and hydrophones <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Tables Table C.1 \u2013 Hydrophone types for pressure pulse measurements <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | C.2 Water test chamber C.2.1 General C.2.2 Degassing procedures C.3 Dry test bench C.3.1 General Table C.2 \u2013 Measurement techniques and probes for quality assurance purposes <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Figure C.1 \u2013 Design example of a dry test bench in two views <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | C.3.2 Selection and attachment of the hydrophone Figure C.2 \u2013 Detail of the measurement chamber item of the dry test bench <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | C.3.3 Attachment of the hand piece C.3.4 Proof of the similarity of measurements in water and the dry test bench C.3.5 Special measurements with the dry test bench <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | C.4 Acoustic pulse energy C.4.1 General <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | C.4.2 Extrapolation of the applicator surface pressure value <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | Annex D (informative)Lists of parameters Table D.1 \u2013 List of device parameters <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Table D.2 \u2013 Pressure pulse parameters <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Table D.3 \u2013 Additional parameters useful for the correlation with biological effects <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | Table D.4 \u2013 Graphical representations of pressure pulse data <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | Table D.5 \u2013 Data of hydrophones and measurement conditions <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Ultrasonics. Non-focusing short pressure pulse sources including ballistic pressure pulse sources. Characteristics of fields<\/b><\/p>\n |