User's Manual

Acclarix AX8 Diagnostic Ultrasound System User Manual Safety
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 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.
 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
professionals identify their latex-sensitive patients, and refer to the March 29, 1991
Medical Alert on Latex products. Be prepared to treat allergic reactions
immediately.
 Improper operation may cause the internal lithium battery (hereinafter called
battery) to be hot, ignited or exploded, and it may lead to the decrease of the
battery capacity. It is necessary to read the user manual carefully and pay more
attention to warning messages.
 Do not touch accessible contacts of electrical equipment and the patient
simultaneously.
 This device is not suitable for intra-cardiac use or direct cardiac contact.
 The system shall not be serviced or maintained while in use with a patient.
 Install the system according the EMC guidance provided in Chapter 14
 Do not stack the system on other electronic equipment.
 The use of transducer and connecting cable not supplied by the manufacturer may
result in increased emissions or decreased immunity of the equipment.
 Refer to Chapter 14 for recommended separation distances from other equipment,
including portable and RF communication devices.
 The power adapter is used to isolate the system from main power. Position the
system so that it is easy to disconnect the device.
 No modification of this equipment is allowed.
 The system should be maintained regularly, at least annually, by a qualified
technician who has adequate training, knowledge and experience. That person
should be familiar with the AX8 Service Manual (P/N: 01.54.002483), available
from your Edan representative.
 Keep non-medical equipment (such as the external printer) out of the vicinity of the
patient. (1.5m/6ft.)
 Use of an extension cord or multi-socket outlet setup to provide power to the
ultrasound system or to the system‟s peripheral devices, may compromise the