Safety; Warnings - EDAN Acclarix LX4 User Manual

Acclarix LX4 Diagnostic Ultrasound System User Manual

2 Safety

Throughout this document the following terms are used:
 Warning: Advises against certain actions or situations that could result in personal injury
or death.
 Caution: Advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
 Note: Provides useful information regarding a function or a procedure.
Please read all warnings and cautions prior to using the system. For your convenience, all
warnings and cautions are provided in this section, but may be duplicated elsewhere in this
document in the context of the instructions for use.

2.1 Warnings

 Only use an Edan supplied power cord.
 Only use Edan supplied transducer. Use of other transducers may result in electric
shock or system malfunction.
 Only use a hospital grade, grounded, power outlet and plug. Do not use with an
ungrounded outlet.
 The system is ordinary equipment (Sealed equipment without liquid proof). The
transducers (not including the transducer connector) are IPX7 certified. The
footswitch is IP68 certified. Do not immerse or expose any of the parts to extended
moisture. Splash resistance does not extend to transducer connectors. Please
keep connectors dry.
 Do not use in a wet environment or when the relative humidity exceeds 95%.
 Do not touch the connector pins on the transducer port.
 Parts and accessories used must meet the requirements of the applicable
IEC/EN60601 series safety standards, and/or the system configuration must meet
the requirements of the IEC/EN60601-1.
 Use protective barriers (gloves and transducer sheaths) whenever possible.
Follow sterile procedures when appropriate. Thoroughly clean Transducers and
reusable accessories after each patient examination and disinfect or sterilize as
needed. Refer to transducer use and care instructions. Follow all infection control
policies established by your office, department or institution as they apply to
personnel and equipment.
 Not intended for Ophthalmic use.
 If a sterile transducer cover becomes compromised during an intra-operative
application involving a patient with transmissible spongiform encephalopathy, such
as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Disease Control
Center and
WHO/CDS/APH/2000/3, WHO Infection Control Guidelines for Transmissible
Spongiform Encephalopathies. The transducers for your system cannot be
decontaminated using a heat process.
 Contact with natural rubber latex may lead to a severe anaphylactic reaction in
persons sensitive to the natural latex protein, Sensitive users and patients must
avoid contact with these items. EDAN strongly recommends that health-care
this document from the World
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Safety
Health Organization: