Needle Biopsy Guide; Installing Needle Guide Bracket - EDAN Acclarix AX4 User Manual

Acclarix AX4 Diagnostic Ultrasound System User Manual

7.5 Needle Biopsy Guide

NOTE: Use proper sterile technique at all times when performing a biopsy.
Always follow these basic precautions:
1. Disinfect the needle guide kit before the first use and after each subsequent use.
2. Calibrate the needle guide kit (see section 7.5.3) under any of the following
conditions:
a) The first time that each bracket/transducer combination is used.
b) If the bracket or transducer head is dropped or struck, or has evidence of wear.
c) If previous use has shown some drift of the needle from the center of the
guidelines.
3. The displayed needle guide pathway on the EDAN video monitor is intended for
reference during biopsy procedures. A variety of factors outside EDAN's control, such
as changing tissue density, bending of the needle, off-axis pressure by the person
holding the transducer, etc., may cause deflection of a needle outside of the
displayed video pathway even when the transducer, needle guide, and the system
software are all performing as intended and within manufacturing specification. The
specialist performing a biopsy procedure must be aware of potential external factors
when performing an invasive procedure.
4. Do not freeze the system when performing a biopsy.
5. EDAN needle guides are designed and manufactured to attach firmly to designated
transducers and should not require excessive force to assemble or disassemble. Do
not use a needle guide that requires excessive force or manipulation to assemble or
disassemble.
6. A single-use sheath should be used on transducer when performing a biopsy.

7.5.1. Installing Needle Guide Bracket

The needle guide bracket kit consists of the needle guide bracket and between 1 to 4
interchangeable guides for different gauge needles (see table 3-2 for details)
Step 1: Take the needle guide bracket kit out of the package. Check to make sure it is the
correct kit for the transducer being used (see table 3-2) and inspect it carefully for any damage.
See figure 7-12 for a typical needle guide bracket kit.
The needle guide bracket kits are not disinfected or sterilized before delivery. Disinfect
the needle guide kit before the first use and after each subsequent use. For detailed
operations, see 12.4.2 Needle Guide Bracket Cleaning and Sterilization.
WARNING
WARNING
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