985-006001 REV. G Effective Date: 03 June 2008
Stereotaxis, Inc.
Page 32 of 43
4.3. Image Transfer from X-ray Companion System
NOTE
If an X-ray system is not available at this time use the X-ray simulator for testing purposes.
No.
Test Description
Pass/Fail Initials
1
Verify that Valid Images can be transferred from the X-ray companion
System to the Niobe
®
System.
•
Take one image, or use the X-ray simulator to send a file, of a
suitable phantom in the x-ray field with the RAO/LAO angle at
least 20
o
. Click the Transfer image button on the display.
•
Verify that the system displays the image transfer in process
icon (same ICON as the transfer image, except arrow goes to
green and background goes to white)
•
Verify that the images are displayed on the Navigant
TM
monitor in two locations.
•
Verify that the transfer time is in the range of 3-5 seconds.
•
Take a second image, or use the X-ray simulator to send a
file, after moving the C-Arm through at least 40
o
of movement
RAO/LAO. Click the Transfer image button on the display.
•
Verify that the system displays the image transfer in process
icon (same ICON as the transfer image, except arrow goes to
green and background goes to white)
•
Verify that the image is displayed on the Navigant
TM
monitor in
two locations.
•
Verify that the transfer time is in the range of 3-5 seconds.
P F
P F
P F
P F
P F
P F
P F
P F
2
Verify that the system will identify invalid images and not permit
magnetic navigation.
•
Repeat above test, however, only move the RAO/LAO
movement 39
o
, or use the X-ray simulator to send a files,
between transferring the first image and the second
image. Verify that the Images Invalid Icon is displayed,
which is a large yellow “X”.
P F