Ultrasonics. Hand-held probe Doppler foetal heartbeat detectors. Performance requirements and methods of measurement and reporting

Ultrasonics. Hand-held probe Doppler foetal heartbeat detectors. Performance requirements and methods of measurement and reporting

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What is BS EN 61266 - Hand-held probe Doppler foetal heartbeat detectors requirements and methods about?

BS EN 61266 is a European standard that discusses Hand-held ultrasonic Doppler foetal heartbeat detectors. BS EN 61266 outlines the:

  • Methods of measurement of performance of a complete ultrasonic hand-held doppler foetal heartbeat detector (hereinafter referred to as “equipment”)
  • Requirements for the performance of equipment
  • Requirements for the reporting of the performance of existing equipment
  • Requirements for the declaration by manufacturers in accompanying literature of aspects of the performance of equipment

BS EN 61266 applies to ultrasonic Doppler foetal heartbeat detectors which generate a single ultrasound beam and consist of a hand-held probe that is applied to the maternal abdomen to obtain information on foetal heart activity through the Doppler method using continuous wave (C.W.) or quasi-continuous wave ultrasound.

Note 1: BS EN 61266 does not cover the continuous monitoring devices which generate more than one ultrasound beam and are usually of the type utilising a similar principle of operation but using a flat probe strapped to the patient.

Note 2: BS EN 61266 is not an equipment design standard.

Who is BS EN 61266 - Hand-held probe Doppler foetal heartbeat detectors requirements and methods for?

BS EN 61266 on hand-held probe Doppler foetal heartbeat detectors requirements and methods is useful for:

  • Manufacturers of hand-held probe Doppler foetal heartbeat detectors
  • Test centres
  • Regulatory authorities

Why should you use BS EN 61266 - Hand-held probe Doppler foetal heartbeat detectors requirements and methods?

Hand-held ultrasonic Doppler foetal heartbeat detectors are widely used for monitoring foetal heartbeat during pregnancy. They normally operate at frequencies of circa 2 MHz and consist of an ultrasonic transducer acoustically coupled to the maternal abdomen and associated electronics.

BS EN 61266 assists you with performance requirements for evaluating Hand-held probe Doppler foetal heartbeat detectors.

BS EN 61266 also provides test methods on acoustic working frequency, output power, spatial-peak temporal-peak acoustic pressure, the effective area of the ultrasonic transducer active element, and overall sensitivity for measuring the overall performance of hand-held probe Doppler foetal heartbeat detectors.

BS EN 61266 also provides you with a preferred method for reporting the performance of existing equipment and specifications for sampling and labelling. This assists in manufacturing efficient hand-held probe Doppler foetal heartbeat detectors that are durable and of high quality.

With obedience and compliance to BS EN 61266, you can improve the performance of hand-held probe Doppler foetal heartbeat detectors and manufacture a standardized product. In addition, minimise hazards to nurses and physicians while operating.