AS/NZS 4512:1999
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Specifies the essential non-thermal output characteristics of ultrasonic surgical units, methods of measurement of these output characteristics, those characteristics which should be declared by the manufacturers of such equipment. This Standard is identical with and has been reproduced from IEC 61847:1998.
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AS/NZS 4512:1999 ULTRASONICS-SURGICAL SYSTEMS-MEASUREMENT AND DECLARATION OF THE BASIC OUTPUT CHARACTERISTICS
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Definitions
3.1 applicator tip; applied part
3.2 directivity pattern
3.3 drive frequency
3.4 duty cycle
3.5 maximum electrical power
3.6 output acoustic power
3.7 derived output acoustic power
3.8 power reserve index
3.9 primary acoustic output area
3.10 primary tip vibration excursion
3.11 primary tip vibration excursion modulation
3.12 pulse duration
3.13 quiescent electrical power
3.14 reference primary tip vibration excursion
3.15 secondary acoustic output area
3.16 secondary tip vibration excursion
3.17 tip vibration frequency
4 List of symbols
5 General measurement requirements
5.1 Operating conditions
5.2 Load conditions
5.2.1 For measurement of derived output acoustic power
5.2.2 For measurements of quiescent electrical power
5.2.3 For measurements of maximum electrical power
5.3 Preparation for measurements
5.3.1 Preparation of the applicator
5.3.2 Preparation of the water
5.3.3 Preparation of the system
6 Measurement procedures
6.1 Primary tip vibration excursion
6.1.1 Optical microscope method
6.1.2 Laser vibrometer method
6.1.3 Feedback voltage method
6.2 Secondary tip vibration excursion
6.2.1 Optical microscope
6.3 Drive frequency
6.3.1 Frequency counter method
6.3.2 Spectrum analyzer method
6.4 Tip vibration frequency
6.4.1 Vibrometer method
6.4.2 Hydrophone method
6.5 Derived output acoustic power and output acoustic power
6.5.1 Derived output acoustic power - Hydrophone method
6.5.2 Output acoustic power - Calorimeter method
6.6 Directivity pattern
6.7 Primary tip vibration excursion modulation
6.7.1 Laser vibrometer method
6.8 Duty cycle
6.9 Quiescent electrical power
6.10 Maximum electrical power
6.11 Primary acoustic output area
6.12 Secondary acoustic output area
6.13 Power reserve index
7 Declaration of output characteristics
Annex A - Measurement methods and conditions
A.1 Optical microscope method
A.2 Vibrometer method
A.3 Output acoustic power using the calorimeter method
A.4 Derived output acoustic power using the pressure method
A.5 Feedback voltage method
A.6 influence of air bubbles and contaminations
A.7 Test tank
A.8 Derivation of formula for derived output acoustic power for the case of a dipole
Annex B - Theory of operation of ultrasonic surgical devices
B.1 Introduction
B.2 System description
B.3 Possible mechanisms of tissue interaction
B.4 Typical values of output and discussion of parameters
B.5 Operating conditions
Annex C - Bibliography
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AS/NZS 4512:1999 ULTRASONICS-SURGICAL SYSTEMS-MEASUREMENT AND DECLARATION OF THE BASIC OUTPUT CHARACTERISTICS
PREFACE
CONTENTS
1 Scope
2 Normative references
3 Definitions
3.1 applicator tip; applied part
3.2 directivity pattern
3.3 drive frequency
3.4 duty cycle
3.5 maximum electrical power
3.6 output acoustic power
3.7 derived output acoustic power
3.8 power reserve index
3.9 primary acoustic output area
3.10 primary tip vibration excursion
3.11 primary tip vibration excursion modulation
3.12 pulse duration
3.13 quiescent electrical power
3.14 reference primary tip vibration excursion
3.15 secondary acoustic output area
3.16 secondary tip vibration excursion
3.17 tip vibration frequency
4 List of symbols
5 General measurement requirements
5.1 Operating conditions
5.2 Load conditions
5.2.1 For measurement of derived output acoustic power
5.2.2 For measurements of quiescent electrical power
5.2.3 For measurements of maximum electrical power
5.3 Preparation for measurements
5.3.1 Preparation of the applicator
5.3.2 Preparation of the water
5.3.3 Preparation of the system
6 Measurement procedures
6.1 Primary tip vibration excursion
6.1.1 Optical microscope method
6.1.2 Laser vibrometer method
6.1.3 Feedback voltage method
6.2 Secondary tip vibration excursion
6.2.1 Optical microscope
6.3 Drive frequency
6.3.1 Frequency counter method
6.3.2 Spectrum analyzer method
6.4 Tip vibration frequency
6.4.1 Vibrometer method
6.4.2 Hydrophone method
6.5 Derived output acoustic power and output acoustic power
6.5.1 Derived output acoustic power - Hydrophone method
6.5.2 Output acoustic power - Calorimeter method
6.6 Directivity pattern
6.7 Primary tip vibration excursion modulation
6.7.1 Laser vibrometer method
6.8 Duty cycle
6.9 Quiescent electrical power
6.10 Maximum electrical power
6.11 Primary acoustic output area
6.12 Secondary acoustic output area
6.13 Power reserve index
7 Declaration of output characteristics
Annex A - Measurement methods and conditions
A.1 Optical microscope method
A.2 Vibrometer method
A.3 Output acoustic power using the calorimeter method
A.4 Derived output acoustic power using the pressure method
A.5 Feedback voltage method
A.6 influence of air bubbles and contaminations
A.7 Test tank
A.8 Derivation of formula for derived output acoustic power for the case of a dipole
Annex B - Theory of operation of ultrasonic surgical devices
B.1 Introduction
B.2 System description
B.3 Possible mechanisms of tissue interaction
B.4 Typical values of output and discussion of parameters
B.5 Operating conditions
Annex C - Bibliography
AS/NZS 4512:1999
Online Library subscription pricing
The cost of your subscription will depend on which standards you want to access, and how many people in your organisation need to be able to access the Online Library subscription at the same time (concurrent users). During your subscription period, we are also able to make any necessary changes and ensure you are aware of any pricing changes that result. For a quote, contact our Online Library team by emailing onlinelibrary@standards.govt.nz.