Section 246-226-020. Equipment requirements.

The CT X-ray system must:

(1) Meet the requirements of 21 C.F.R. Sec. 1020.33 (last amended June 10, 2005) at the time of installation and while the CT X-ray system is registered with the department under chapter 246-224 WAC; and

(2) Be equipped:

(a) With a visible signal that indicates when the X-ray exposure is occurring;

(b) So that the operator can immediately terminate an X-ray exposure of greater than one-half second duration at any time during the X-ray exposure;

(c) So that the parameters used during a CT procedure are:

(i) Displayed prior to beginning a scan; and

(ii) Visible by the operator from any location scanning can be initiated.

(d) So that radiation leakage from the tube port does not exceed limits established in WAC 246-225-040 (3) and (4) when data are not being collected for image production;

(e) So that the accuracy of the laser or optical positioning system is within five millimeters maximum deviation on the axial position (z-axis);

(f) With an X-ray production indicator of at least one-half second at or near the gantry that is visible from any point outside the gantry opening;

(g) So that premature termination of the X-ray exposure by the operator requires resetting of the parameters prior to initiating another scan.

[Statutory Authority: RCW 70.98.050 and 70.98.080. WSR 16-23-030, § 246-226-020, filed 11/8/16, effective 1/1/17.]

RCW 70.98.050 and 70.98.080. WSR 16-23-030, § 246-226-020, filed 11/8/16, effective 1/1/17.

Rules

246-224,246-225-040,