AS/NZS 4512:1999

Table of Contents

1 -  AS/NZS 4512:1999 ULTRASONICS-SURGICAL SYSTEMS-MEASUREMENT AND DECLARATION OF THE BASIC OUTPUT CHARACTERISTICS
4 -  PREFACE
5 -  CONTENTS
7 -  1 Scope
7 -  2 Normative references
8 -  3 Definitions
8 -  3.1 applicator tip; applied part
8 -  3.2 directivity pattern
8 -  3.3 drive frequency
8 -  3.4 duty cycle
8 -  3.5 maximum electrical power
8 -  3.6 output acoustic power
9 -  3.7 derived output acoustic power
9 -  3.8 power reserve index
9 -  3.9 primary acoustic output area
9 -  3.10 primary tip vibration excursion
9 -  3.11 primary tip vibration excursion modulation
9 -  3.12 pulse duration
10 -  3.13 quiescent electrical power
10 -  3.14 reference primary tip vibration excursion
10 -  3.15 secondary acoustic output area
10 -  3.16 secondary tip vibration excursion
10 -  3.17 tip vibration frequency
11 -  4 List of symbols
11 -  5 General measurement requirements
11 -  5.1 Operating conditions
11 -  5.2 Load conditions
11 -  5.2.1 For measurement of derived output acoustic power
12 -  5.2.2 For measurements of quiescent electrical power
12 -  5.2.3 For measurements of maximum electrical power
12 -  5.3 Preparation for measurements
12 -  5.3.1 Preparation of the applicator
12 -  5.3.2 Preparation of the water
12 -  5.3.3 Preparation of the system
12 -  6 Measurement procedures
12 -  6.1 Primary tip vibration excursion
12 -  6.1.1 Optical microscope method
12 -  6.1.2 Laser vibrometer method
13 -  6.1.3 Feedback voltage method
13 -  6.2 Secondary tip vibration excursion
13 -  6.2.1 Optical microscope
13 -  6.3 Drive frequency
13 -  6.3.1 Frequency counter method
13 -  6.3.2 Spectrum analyzer method
13 -  6.4 Tip vibration frequency
13 -  6.4.1 Vibrometer method
13 -  6.4.2 Hydrophone method
14 -  6.5 Derived output acoustic power and output acoustic power
14 -  6.5.1 Derived output acoustic power - Hydrophone method
15 -  6.5.2 Output acoustic power - Calorimeter method
15 -  6.6 Directivity pattern
15 -  6.7 Primary tip vibration excursion modulation
15 -  6.7.1 Laser vibrometer method
16 -  6.8 Duty cycle
16 -  6.9 Quiescent electrical power
16 -  6.10 Maximum electrical power
17 -  6.11 Primary acoustic output area
17 -  6.12 Secondary acoustic output area
17 -  6.13 Power reserve index
17 -  7 Declaration of output characteristics
23 -  Annex A - Measurement methods and conditions
23 -  A.1 Optical microscope method
23 -  A.2 Vibrometer method
23 -  A.3 Output acoustic power using the calorimeter method
24 -  A.4 Derived output acoustic power using the pressure method
25 -  A.5 Feedback voltage method
25 -  A.6 influence of air bubbles and contaminations
25 -  A.7 Test tank
25 -  A.8 Derivation of formula for derived output acoustic power for the case of a dipole
28 -  Annex B - Theory of operation of ultrasonic surgical devices
28 -  B.1 Introduction
28 -  B.2 System description
29 -  B.3 Possible mechanisms of tissue interaction
29 -  B.4 Typical values of output and discussion of parameters
30 -  B.5 Operating conditions
31 -  Annex C - Bibliography

Abstract

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.

Scope

This International Standard specifies:
û the essential non-thermal output characteristics of ultrasonic surgical units;
NOTE 1 û One of the parameters of interest is output acoustic power. This standard addresses only the low-frequency (under 100 kHz) component of the total delivered energy. The high-frequency component, which probably relates to cavitation developed at the tip, is not addressed (see A.4).
û methods of measurement of these output characteristics;
û those characteristics which should be declared by the manufacturers of such equipment.
NOTE 2 û In the interest of clarity, this standard does not address all of the complex surfaces and shapes possible for applicator tips. A straight tubular shape is used in the description of the parameters and measurements to be made. It is left to the user of this standard to adapt the basic methodology described to more complex designs if required.

This International Standard is applicable to equipment which meets the requirements of a, b and c below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and
b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and
c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.

NOTE 3 û Examples of these types of systems are surgical aspirators, intracorporeal lithotripters, end-cutting devices etc.

This International Standard is not applicable to:
û lithotripsy equipment which uses extracorporeally induced pressure pulses, focussed through liquid conducting media and the soft tissues of the body;
û surgical devices used as part of the therapeutic process (hyperthermia systems);
û surgical devices whose acoustic application areas are not at the end of a longitudinally vibrating applicator tip and therefore would not fit the monopole model used in this standard.

This International Standard does not deal with the effectiveness or safety of ultrasonic surgical systems.

NOTE 4 û Throughout this standard, the term accuracy means the overall uncertainty expressed at the 95 % confidence level.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Pages
ISBN
Committee	HE-003
Supersedes	DR 98339