FujiFilm Sonosite PX System, Service Manual

Page: 19 / 110

Chapter 3: Safety 11
Chapter 3: Safety
This chapter contains electrical and clinical safety information required by regulatory agencies. The
information applies to the ultrasound system, transducers, accessories, and peripherals.
Electrical safety
This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF
(transducers) isolated patient-applied parts safety requirements.
This system complies with the applicable medical equipment requirements published in the Canadian
Standards Association (CSA), European Norm Harmonized Standards, and Underwriters Laboratories (UL)
safety standards.
For maximum safety observe the following warnings and cautions..
WARNING:
To avoid discomfort or minor risk of patient injury, keep hot surfaces away from
the patient.
WARNING:
To avoid the risk of injury, do not operate the system in the presence of
flammable gasses or anesthetics. Explosion can result.
WARNING:
To avoid the risk of electrical shock or injury, do not open the system
enclosures. All internal adjustments and replacements, including battery
replacement, must be made by a qualified technician.
WARNING:
To avoid the risk of electrical shock:
• Use only properly grounded equipment. Shock hazards exist if the power
supply is not properly grounded. Grounding reliability can be achieved only
when equipment is connected to a receptacle marked “Hospital Only” or
“Hospital Grade” or equivalent. The grounding wire must not be removed or
defeated.
• This equipment must be connected only to supply mains with protective earth.
• Do not let any part of the system (including the bar code scanner, power
supply, or power supply connector), except for the transducer, touch the
patient.
• Do not touch any of the following:
• The signal input/output connectors on the system and the stand.
• The system battery contacts (inside the battery compartment)
• The system transducer connector on the bottom of the system when
the system is used off the stand and the transducer is disconnected
• Any unused transducer connector when the system is installed on
the stand.