Cautions - EDAN Acclarix AX4 User Manual

Acclarix AX4 Diagnostic Ultrasound System User Manual
ultrasound system or to the system's peripheral devices, may compromise the
system grounding and cause the system to exceed current leakage 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 comply 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 IMT is correctly traced prior to entering the IMT result into the
report.
 The system may be interfered with by other equipment, even if that other
equipment complies with CISPR EMISSION requirements.
 The system cannot be used together with high-frequency surgical equipment.
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 intra-operative procedures.
 The system is not intended to come into contact with the central nervous system
and the central cardiovascular system.
 Unplug the transducer from the system prior to cleaning or disinfecting.
 Do not immerse the transducer beyond the point indicated in
 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
- 7 -
Safety
Figure 6-2.