EDAN Acclarix AX15, User Manual

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Acclarix AX3 Series Diagnostic Ultrasound System User Manual Safety
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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 Edan supplied power adapter and power cord.

Only use Edan supplied battery. Read and understand the battery installation instructions prior
to changing the battery.

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 transducer connector) is 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 reverse the positive and negative poles when installing the battery.

Do not use the battery near heat sources or when the ambient temperature is over 40
o
C. Do
not heat or dispose of in fire.

Do not destroy the battery; do not pierce or cause a strong impact to the battery.

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 this document from the
World Health Organization: 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.