User's Manual

Acclarix AX8 Diagnostic Ultrasound System User Manual Safety
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system grounding and cause the system to exceed leakage current limits.
 SHOCK HAZARD – Do not connect non-isolated electrical equipment to the same
circuit being used to power the system.
 Edan recommends the use of isolated connectors on any electrical equipment
attached to the system, and/or using isolation transformers that complies with
IEC60601-1 to power that electrical equipment.
 Always use sterile technique during a biopsy procedure. Sterilize the needle
guide assembly between uses.
 Use a sterile needle with each use.
 Always confirm the clinical accuracy of the IMT result before entering it into the
report.
Transducer Warnings
 To avoid infection, always use protective gloves when cleaning or disinfecting
 Read and follow all manufacturer instructions for disinfection agents.
 To avoid infection, ensure that expiration date of the disinfecting solution has not
passed.
 Disinfect the transducer after each intra-cavity or intra-operative procedure. Use a
new sterile sheath for each such procedure.
 Use a pyrogen-free transducer sheath for neurological intra-operative procedures.
 Unplug the transducer from the system prior to cleaning or disinfecting.
 Do not immerse the transducer beyond the point indicated in Figure 6-2.
 Do not allow the transducer connector to get wet.
2.2 Cautions
 The system contains no user serviceable components other than the battery. Do
not remove any covers.
 Excessive dust and dirt could clog internal airflow and cause overheating. Do not
use in a dusty environment.
 Do not use a battery that leaks, emits an odor, appears deformed, or discolored.
Immediately replace it with a new Edan-supplied battery and dispose of the old
battery according to local regulations. Replace a battery that has reached the end
of its service life.
 Use care when storing or disposing of batteries. Do not allow the leakage to come
in contact with each other. Do not dispose of them together with household
garbage. At the end of their life hand the batteries over to the applicable collection
points for the recycling of waste batteries.
 Inspect the system regularly, at least weekly. Before use ensure there is no visible