FujiFilm Sonosite PX System, Service Manual

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24 Chapter 3: Safety
Essential performance requirements
Per 60601-2-37, the following have been determined to be essential performance for the Sonosite PX
ultrasound system. The Sonosite PX ultrasound system must be free from the following:
• Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that
cannot be attributed to a physiological effect and that may alter the diagnosis
• Display of incorrect numerical values associated with the diagnosis to be performed
• Display of incorrect safety related indications
• Production of unintended or excessive ultrasound output
• Production of unintended or excessive transducer assembly surface temperature
• Production of unintended or uncontrolled motion of transducer assemblies intended for intracorporeal
use.
Results of EMC immunity testing show that the Sonosite PX ultrasound system meets the essential
performance requirements in 60601-2-37. If the operator detects unacceptable degradation of basic safety
or essential performance, they should stop using the equipment and take suitable precautions as detailed
on
page 12 .
FCC Caution: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a professional healthcare facility environment. This equipment generates,
uses and can radiate harmful radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful interference to
other medical or electronic equipment, take suitable precautions as detailed on page 12.
Standards
Electrical safety standards
ANSI/AAMI ES60601-1:2005/(R) 2012, and A 1:2012 Medical electrical equipment, Part 1: General
requirements for basic safety and essential performance (Edition 3.1)
CAN/CSA C22.2 No. 60601-1:2014 Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance (Edition 3.1)
IEC 60601-2-37:2008 (+A1:2019) Medical electrical equipment - Part 2-37: Particular requirements for the
basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment
(Adopted IEC 60601-2-37:2007, Edition 2.1)
CSA C22.2 60601-1-6:2011 (+A1:2013) Medical Electrical Equipment Part 1-6: General requirements for
basic safety and essential performance - Collateral Standard: Usability (Adopted IEC 60601-1-6:2013,
Edition 3.1)
IEC 60601-1:2012 Medical electrical equipment, Part 1: General requirements for basic safety and essential
performance (Edition 3.1)
a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Fujifilm Sonosite ultrasound
system is used exceeds the applicable RF compliance level above, the Fujifilm Sonosite ultrasound system should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Fujifilm Sonosite ultrasound system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.