Ultrasonics. Surgical systems. Measurement and declaration of the basic output characteristics

Ultrasonics. Surgical systems. Measurement and declaration of the basic output characteristics

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1   Scope

This document specifies:
  1. - the essential non-thermal output characteristics of ultrasonic surgical units;

    NOTE 1 One of the parameters of interest is output acoustic power. This document primarily addresses the low-frequency (under 120 kHz) component of the total delivered energy. The high-frequency component, which relates to cavitation developed at the tip, is discussed in Clause A.4.

  2. - methods of measurement of these output characteristics;
  3. - those characteristics to be declared by the manufacturers of such equipment.

    NOTE 2 In the interest of clarity, a straight tubular shape is used in the basic description of the parameters and measurements to be made. Guidance is provided to the user of this document to adapt the basic methodology described to more complex designs as required. It is recognized that complex designs and vibration patterns are design features of many surgical systems, and therefore it is important that output characteristics be declared for those conditions.

This document is applicable to equipment which meets the criteria of a), b) and c) below:
  1. a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and
  2. b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and
  3. 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 Examples of these types of systems are surgical aspirators, phacoemulsifiers, intracorporeal lithotripters, end-cutting systems, ultrasonic liposuction systems, etc.

    NOTE 4 The upper frequency limit has been set to accommodate more recently developed systems operating at higher frequencies than IEC 61847:1998. The techniques of this document are also useful for systems operating at higher frequencies that use the same mechanisms of action.

This document is not applicable to:
  1. - lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body;
  2. - surgical systems used as part of the therapeutic process (hyperthermia systems);
  3. - surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters;
  4. - surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound - HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer;
  5. - surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling.

    NOTE 5 Limited declaration requirements for surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip are listed in Clause 7.

This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients.

NOTE 6 Airborne noise levels are addressed in IEC 60601-1[1]1.

NOTE 7 The safety of ultrasonic surgical systems for ophthalmic applications are addressed in IEC 80601-2-58[2].

NOTE 8 Throughout this document, the term accuracy means the overall uncertainty expressed at the 95 % confidence level.