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{ServiceManual}{Production}{Health Group}{Restricted}

Publication No. 6H1307


20MAY09

KODAK Point-of-Care CR-ITX 560 System


Installation and Start-Up

© CARESTREAM HEALTH, INC. 2009


PLEASE NOTE The information contained herein is based on the experience and knowledge relating to the
subject matter gained by Carestream Health, Inc. prior to publication.
No patent license is granted by this information.
Carestream Health, Inc. reserves the right to change this information without notice, and makes
no warranty, express or implied, with respect to this information. Carestream Health shall not be
liable for any loss or damage, including consequential or special damages, resulting from any
use of this information, even if loss or damage is caused by Carestream Health’s negligence or
other fault.
Copyright Carestream Health, Inc., 2008
All rights reserved. No part of this manual may be reproduced or copied in any form by any means–graphic, electronic
or mechanical, including photocopying, typing, or information retrieval systems–without written permission of
Carestream Health, Inc.

Use of Manual
The CR-ITX 560 System is designed to meet international safety and performance standards. Personnel operating
the system must have a thorough understanding of the proper operation of the system. This manual has been
prepared to aid medical and technical personnel to understand and operate the system. Do not operate the system
before reading this manual and gaining a clear understanding of the operation of the system. If any part of this manual
is not clear, please contact your Carestream Health representative for clarification.

2 20MAY09 – 6H1307
Table of Contents
Description Page

General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Performing the Work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Information about Product Safety and Protective Measures . . . . . . . . . . . . . . . . . . . 7
System Overview - User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
System Overview - Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Installation Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
General Information about Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Required Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Required Tools, Test Equipment, and Aids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Information about the Start-up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Unpacking and Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Components Shipped with the CR-ITX 560 System . . . . . . . . . . . . . . . . . . . . . . . . . 16
Tools Needed to Uncrate the CR-ITX 560 System . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Line Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Identification (Labeling) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Operating Elements and Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Mechanical Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Cable Rewinder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Support Arm Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Single Tank or Collimator Movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Regional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
ELO Touchscreen Desktop Shortcut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Network Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
KODAK QC Software Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Set Up Image Path . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
DICOM Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Configuring a RIS/HIS Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Configuring the DICOM Send Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Managing Disk Space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Configuring Customer Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Configuring a PACS Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Configuring a DICOM Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Configuring a DICOM Printer with KODAK Quality Control Software
for Point-of-Care CR Systems, Version 2.5.and Higher . . . . . . . . . . . . . . . . . 33
Configuring Viewer Overlays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Configuring X-ray Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
kV/mAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Sending an SMPTE Image to the Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Installing and Configuring the DAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Configuring the USB to the COM Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

20MAY09 – 6H1307 3
Clear Images Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Perform Clear Images when Restarting the Imaging System. . . . . . . . . . . . . . . 49
Creating the Clear Images Service in the Scheduled Tasks . . . . . . . . . . . . . . . 49
Configuring the KODAK QC High/Low Database Limits. . . . . . . . . . . . . . . . . . . 52
Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Multileaf Collimator Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Exposure Release with High Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Manual Termination of an Exposure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
DAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Remote Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Final Activities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Protective Conductor Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Leakage Current Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Gain Tuning Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Half Layer, X-ray. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Luminous Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
SID Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Focal Spot Size, X-ray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Light Field/Radiation Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Collimator Blade Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
USA and European Test Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
DHHS Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
kV Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
mAs Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Reproducibility Test (USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Test Procedure for Low Dose Images (German Prufung DIN 6868-58). . . . . . . . . . . 68
Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Test Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Phantom Exposure and Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Final Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Performance Image Quality Verification of CR-ITX 560 Medical Systems (ATP) . . . . . . . 70
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
List of Equipment Required for Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
List of Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Before Starting the Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Acceptance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
1. Physical Inspection and Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
2. Dark Noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
3. Erasure Thoroughness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4. Spatial Resolution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
5. Low Contrast Resolution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6. System Response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
7. Artifacts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
8. Return the Image Data Correction to KODAK Processing . . . . . . . . . . . . . . . 74
Recommended Testing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Gain Tuning and Verification Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Gain Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Cleaning the Storage Phosphor Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Backing Up the Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Creating and Restoring Ghost Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Ghost imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Creating a Ghost Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Restoring a Ghost. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

4 6H1307 – 20MAY09
Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Start-up Report CR-ITX 560 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Protective Conductor Resistance Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Leakage Current Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
DHHS report (USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Prufung Test Results Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Acceptance Test Procedure (ATP) for CR-ITX 560 System . . . . . . . . . . . . . . . . . . . 88
FDA Form 2579 (USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Appendix A - WIISE Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
WIISE Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Dark Noise Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
System Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Spatial Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Publication History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

20MAY09 – 6H1307 5
Section 1: General Information

Performing the Work


Any technician duly assigned by the local Carestream Health office is authorized to perform maintenance and service
work.
Certain tasks may also be performed by other technical personnel (e.g., the customer’s hospital technicians). These
tasks are marked by the icon shown here.

In such cases, it is absolutely necessary:


• To observe all instructions in the text and graphics.
• To use the specific tools, test equipment, and aids.
You can also contact your country’s Carestream Health Service Center for support.

Icons

Warning about ionizing radiation or radioactive substances. Tests and adjustments that must be
performed with the radiation switched on are indicated by this radiation warning icon.

Dangerous electrical voltage >25 VAC or > 60 VDC.

Caution! General hazard warning.

ESD: Warning about electrostatically sensitive components.

Report icon. Used to indicate entries in certificates.

Certain tasks can also be performed by other technical personnel (e.g., the customer’s hospital
technicians).

Certain sections apply only to the U.S. These sections are marked with this icon.

6 6H1307 – 20MAY09
Information about Product Safety and Protective Measures

Caution
Lethal electric shock and radioactive contamination hazards exist.
• Individuals can come into contact with dangerous components while troubleshooting or servicing the equipment.
• Some tests and adjustments must be performed with radiation turned on.
Disregarding the safety instructions will lead to death or serious bodily injury.
When performing service and tests always observe:
• The product-specific safety information contained in the technical documentation.
• The general safety information.
Remove or install components only when:
• The system is de-energized, and
• The capacitors are discharged, and
• The batteries are disconnected.
Tests and adjustments that must be performed with the radiation switched on are marked by the radiation warning
icon shown below.

The required radiation protection measures must be followed for these adjustments.
Lethal shock hazards exist.
Anyone performing troubleshooting and/or service with the safety covers off may come into contact with live parts.
The hazard exists as long as:
• The power supply is connected.
• The capacitor bank or individual capacitors are still charged; capacitors may still be charged even when the
system is de-energized and the power cord is disconnected (e.g., due to defective fuses).
• The battery blocks are connected.
Make sure that no parts or tools fall into the system.
Do not touch potentially dangerous components (see Locations with Dangerous Voltage on Page 8).
If loose parts must be removed from the system, use only insulated tools.
Protect the work area so that no other persons are able to touch the system while the covers are open or removed.
• De-energize the system before servicing or performing maintenance. Always disconnect the power plug first.
• Make sure that the main switch is switched off.
• The capacitor bank discharges to <40V in approximately 15 minutes.
• The safety covers can be removed after this period has elapsed. The locations with dangerous voltage still
require extreme caution (see Locations with Dangerous Voltage on Page 8).

20MAY09 – 6H1307 7
Locations with Dangerous Voltage

440V DC

440V DC

1/2 line
power AC
300V DC
(Hybrid)

With the housing covers open and the safety covers removed:
• Back: Dangerous DC voltage (440 V DC) on capacitor bank (D927).
• Left: Dangerous DC voltage (440 V DC) directly on capacitor bank.
• Right: Dangerous DC voltage (440 V DC) directly on capacitor bank.
• Dangerous AC voltage (>100 V AC or >60 V AC half line voltage) on power supplies U1 and U2 as long as the
power cord is connected.
• Dangerous DC voltage (300 V DC) from the battery block to PCB D982.
Always disconnect the battery plug from BK1 - BK4.

8 6H1307 – 20MAY09
Section 2: System Overview - User

Overview
User Overview

Item Description
1 Lead apron bracket
2 Articulated arm
3 IR remote control (optional)
4 DAP display / chamber (optional)
5 Exposure switch (S27)
6 Control panel and display field
7 Transport handle / motor control
8 Hand / parking brake handle
9 Main switch
10 Power cord
11 Brake handle for cable winch
12 Multileaf collimator
13 Tube unit / single tank

20MAY09 – 6H1307 9
Orientation
Top View of System

System Orientation to Clarify the Technical Description


Uv User view - back (User view)
L Left side of system (left)
R Right side of system (right)
F Front side (front)
fw Front wheels (front wheels)
sa Support arm (support arm)
T Tube (single tank)
C Multileaf collimator (collimator)
dd DAP display (dose display)

Note
These orientation indicators are used in all technical documents. Descriptions are always from the “forward travel”
user view. Always use this perspective when communicating with third parties (e.g., USC/HSC).

10 6H1307 – 20MAY09
System Overview - Service
Schematic Overview

20MAY09 – 6H1307 11
CR-ITX 560 System Components
Item Description
D916 CPU board / X-ray interface
SW1 Key switch, power ON/OFF
Z1 Line filter
C1 (R1) Capacitor for inverter with discharge resistor (front left side; not shown here)
C2 (R2) Starter capacitor with discharge resisitor
R3 - R5, R6 (X9) Discharge resisitor capacitor bank (front right side)
Capacitor bank 12 x 10 mF capacitors, mounted on D972
K22 Main relay
D909 X-ray display and keyboard
U1 +5V/±15V power supply
U2 +24V power supply
U3 Scanner, display +24V power supply
U4 Power supply for U5 (laptop)
U5 Laptop power supply
D927 Power supply
D952 Capacitor bank charging board (behind D927)
D962 kV inverter (behind D927)
D972 Capacitor bank board (behind D927)
Sa Support arm adjusting spring
lw/rw/sw Support rollers and back wheels
D982 Battery charger
D102 Motor drive control
BK1/BK2 Battery block, left
BK3/BK4 Battery block, right
mr/ml Motor right / motor left
PC Laptop for imaging system
DAP chamber (optional) Dose area product measuring chamber; not shown here
D991 (optional) DAP adapter card; not shown here
DAP display DAP display board; not shown here

12 6H1307 – 20MAY09
Cleaning

Preventive Maintenance
Cleaning the DAP Once a month See Chapter 10, “Cleaning” in the User Guide, 7H7773.
Cleaning the phosphor screen Once a month
Cleaning the cassette Once a month
Cleaning the TFT Once a day
Cleaning the rollers Once a month

• Always disconnect the CR-ITX 560 from the power supply and de-energize it before cleaning or disinfecting it.
• Never use abrasive cleaners or cleaning agents with solvents (e.g., cleaning solutions, alcohol, or spot
removers), since they may damage the housing surfaces.
• Do not spray anything on or into the system.
• Wipe off the CR-ITX 560 with a cloth moistened with water or a diluted, lukewarm solution containing water and
dishwashing liquid.
For more information, see the section on “Cleaning and Disinfection” in the User Guide.

Installation Time
The projected installation time for the CR-ITX 560 System is seven (7) hours.
Five (5) hours for the setup and checkout (including the ATP) and two (2) hours for network connectivity.
If additional time is required to install the system, use the appropriate FF code to record the additional hours.

20MAY09 – 6H1307 13
Section 3: General Information about Start-up

Required Documents

Required Tools, Test Equipment, and Aids


• Standard service tool kit
• Digital multimeter
• Storage oscilloscope (TL5402)
• Dosimeter; kV meter (TL5417)
• mAs meter (TL5419)
• Metron QA - ST MK II Tester: 120 V AC (TL5954) (USA and Japan) or Fluke 175
• Metron QA - ST MK II Tester: 230 V AC (TL 5955)
• Calibration Kit (SK000001), which consists of:
– Low contrast phantom (SR000200)
– Phantom plate for body equivalent (SR000201) - German Prufung Test
– Plate copper (SR000202)
– Plate aluminum (SR000203)
– Resolution phantom 26 groups
• Filters, half layer (TL 5473)
• Light meter (TL5614)
• USB hub, keyboard, and mouse (procure locally)
• FDA form 2579 (U.S. only) (P/N 4E3376)
• Laser safety glasses (TL5693)
• 0.9 mm Allen wrench (TL6503)

14 6H1307 – 20MAY09
Information about the Start-up Procedure
The start-up procedure described here corresponds to a functional test. All adjustments and calibrations are
performed at the factory. The CR-ITX 560 is ready for operation on completion of the start-up report.
The system can be connected to line voltages of 100-130 V (± 10%) or 200-240 V (± 10%). The system automatically
adjusts to the existing line voltage.
Observe the nominal current of the fuses for the on-site power connections: 15A slow-blow (on-site) for 100-
130V ± 10% or 15A slow-blow (on-site) for 200-240 V ± 10% line voltage.
The power cable for this device is equipped with a standard safety plug.
Attach a power plug that is compliant with local standards if necessary.
Following start-up, country-specific tests must be performed if necessary (e.g., acceptance test according to §16 of
the X-ray Ordinance (Germany):
Use the measurements in the test certificate provided as the initial values for the required measurements.
The following values were measured by the manufacturer; refer to the test certificate:
• Brightness of the light localizer
• Filter values (Al equivalent for tube assembly and collimator)
• Coincidence of light field and radiation field
• Accuracy of the tube voltage
• Accuracy of the kV value steps
• Accuracy of the mAs values
• Reproducibility of dose values
• Focal spot size
The test/measured values marked by the report icon must be entered in the start-up report located at the end of this
manual.
Recording information immediately during start-up saves time. Fill in the report form after completing each task.
The start-up report is a component of this documentation.

20MAY09 – 6H1307 15
Section 4: Unpacking and Visual Inspection

Components Shipped with the CR-ITX 560 System


• Exposure switch with cord
• Two (2) European electrical connectors
• Warning labels
• Two (2) spacers, transport safeguard hook
• Remote exposure switch kit (two transmitters and one mount), if this option was purchased.
• Two (2) scanner fuse kits (SK270022)
• Four (4) cassettes:
– two (2) 14 x 17 in.
– two (2) 10 x 12 in.
• Angle Indicator
• Apron hanger
• Ethernet cable 5 m (16 ft)
• Screen extractor tool
• Roller cleaning tray
• One (1) package of roller cleaning sheets (contains 2 sheets)
• One (1) hard copy of the User Guide in English
• One (1) CD-ROM that contains translated versions of the User Guide
• One (1) CD-ROM that contains a ghost image of the PC
• Manufacturers certificates

Tools Needed to Uncrate the CR-ITX 560 System


• 19 mm socket wrench
• 13 mm socket wrench
• 13 mm wrench
• Small pry bar or flat head screwdriver
• Pliers
• Hammer
• Diagonal cutters

16 6H1307 – 20MAY09
Unpacking

• Follow the instructions in the above figure.


• Check the manual movement mode and the hand brake.

Visual Inspection
• Check the system for external damage (cracks, breaks, scratches, corrosion, etc.).
• Check whether the single tank or the multileaf collimator show any signs of mechanical defects which might
impair the radiation protection.

20MAY09 – 6H1307 17
Line Voltage

Check the local line voltage by testing a power outlet with the DVM.
The system automatically adjusts to the local (existing) line voltage.
Check the power plug:
• Check the plug for proper functioning.
• Open the plug and check the terminals and strain relief.
The ground wire must be slightly longer than the other wires (applies to all plug types).

Important
Even if the system arrives with a plug already installed. Open the plug and check that it is wired properly.

Power Plug

U.S. Wiring Color Code and Prong Color Code

18 6H1307 – 20MAY09
Assembly

[1] Attach the apron hanger.


[2] Attach the two transport safeguard hook spacers.

[3] Attach the remote exposure switch, if this option was purchased.

20MAY09 – 6H1307 19
Identification (Labeling)

All identification labels are included in the scope of delivery.


• Check the labeling according to the “Labels” chapter in the Operator Manual.
• The device identifier should be entered in the start-up report.

Regional Labeling
• Attach the radiation warning label to the control panel. Select the correct language version.
• Only if required by the user: Attach the “Do not open doors with the device” label as shown below.

For Germany only:


[1] Select the 1.5 m, 2.5 m, or 3.5 m “control area” label as required by the customer and attach it to the bottom of
the arm as shown below.

20 6H1307 – 20MAY09
[2] Attach the warning label to front cover above the TFT.

Operating Elements and Displays

[1] Connect the power plug and check whether the AC symbol (~) illuminates on the control panel.
[2] Energize the system.
[3] Wait for initialization (audible acoustic signal and flashing kV- / mAs displays).

Note
If the system has not been used for some time, error ERR13 may appear, indicating a high device leakage current
on the capacitor bank.
• De-energize the system and then energize it again to correct this problem.
• If the error persists after several power-off/on cycles, perform the “Forming the capacitor bank” service step as
described in the troubleshooting instructions.
[4] Select all values using the “± kV/ ± mAs” keys.

20MAY09 – 6H1307 21
Mechanical Function Test
Cable Rewinder

• Pull out the cable until it is completely unwound.


• Hold the cable with one hand near the duct to slow it down as it is being wound. Pull up the brake of the cable
winch and wind up the cable completely.
This device is equipped with a standard safety plug. If necessary, attach a power plug that is compliant with local
standards.

Support Arm Movements

[1] Unlock the support arm.


[2] Check the support arm movement, including several stops.
[3] Check that the DAP chamber is attached to the collimator, if this option was purchased.

Note
The arm should be easy to move through its full range using one hand and should stop in any position without any
additional movement (up or down).
Positioning of Support Arm

22 6H1307 – 20MAY09
Single Tank or Collimator Movements

• Turn the collimator with the handle to the end position + 90°.
• Rotate the tube to all of its commonly used working and park positions.

20MAY09 – 6H1307 23
Section 5: Settings

Login
[1] Login to the KODAK QC application using the default User Name “admin” and Password “admin”.

Note
The User Name is case-sensitive.

Regional Settings
[1] Exit to the Desktop.
[2] Select Start>Setting>Control Panel.
[3] Select the Regional and Language options.

[4] Select the “Advanced” tab.


[5] Select the “Regional Options” tab and select the same language on both drop-down lists.

[6] Select the “Languages” tab and click Details.

24 6H1307 – 20MAY09
[7] Select the “Settings” tab and select the same language as before from the Default input language list.
If the language is not in the list, click Add to install it.

[8] Click [Apply].


[9] Click [OK].
[10] Reboot the computer.

Note
If you want the KODAK QC Software to be installed in your local language install the KODAK QC Software only after
you configure the default language.

Date and Time


[1] Exit to the Desktop.
[2] Select Start>Settings>Control Panel.
[3] Double-click the “Time and Date” icon.
[4] Change the Time Zone, Date, and Time.

20MAY09 – 6H1307 25
ELO Touchscreen Desktop Shortcut
During installation, add a shortcut on the Desktop for calibrating the touchscreen.
[1] Exit to the Desktop.
[2] Attach an external USB Mouse.
[3] Select Start>Settings>Control Panel.
[4] Right-click the ELO Touchscreen icon.
[5] Select “Create Shortcut”.

Note
The Shortcut error message appears.

[6] Click [Yes].

Note
A shortcut is created on the Desktop.

Network Setting
[1] Exit to the Desktop.
[2] Attach a USB mouse and keyboard.
[3] Select Start>Settings>Control Panel.
[4] Double-click the Network Connections icon.
[5] Right-click the Local Area Connection icon.
[6] Select “Properties”.

26 6H1307 – 20MAY09
[7] Highlight “Internet Protocol (TCP/IP)”.

[8] Click [Properties].


[9] The default setting is “Obtain an IP address automatically”. If the site wants to use a static (permanent IP
Address), select “Use the following IP address”.
[10] Enter:
• IP address
• Subnet mask
• Default gateway

Note
If using a static IP address, a default Gateway must be entered.

[11] Click [OK].


[12] Click [Close].
[13] Reboot the computer.

20MAY09 – 6H1307 27
KODAK QC Software Configuration
Most of the items should probably be configured by the Application Consultant. The following items should be
configured at installation.

Anatomical AC, KeyOp


Calibration Not required
Diagnostics Not required
SW Update & Backup FE
Setup FE
Image Path
DICOM Setting
User FE, AC, KeyOp
Admin FE, AC, KeyOp

Note
For the DICOM setup, configure both the Settings and Destinations and Printers tabs.

Set Up Image Path


[1] Select Settings>Setup.
[2] In Image Path, click [Browse].
[3] Highlight Local Disk (D:).
[4] Click [OK].

28 6H1307 – 20MAY09
DICOM Configurations
Configuring a RIS/HIS Connection
[1] Select Settings>Setup.
[2] Select DICOM Settings.
[3] Fill in the MWL details.
[4] Click [Save].

Note
On the Modality worklist, the Host Name / IP, Port, and Called AE Title are HIS/RIS values and are required. If the
AE Title of the CR-ITX 560 System is needed, try the values in this order:
1. None
2. Called AE title
3. Station name
4. AE title
[5] Configure the “Query” file, then click [Update].
Show results from RIS query
which contains studies from today only.
(Today is from 00:00 till 23:59
of the current calendar day)

Show results from the RIS query


which contains last 24 hours only.
(Today is from 00:00 till 23:59
of the current calendar day)
Modality code that the site is using
Refresh the MWL screen when
re-entering the MWL screen.

Requesting specific patient ID


(for search in user screen)
Requesting specific Accession No.
(for search in user screen)
Requesting specific patient name
(for search in user screen)

Set the network time-out (15 to 120 sec.)

20MAY09 – 6H1307 29
Note
On the KODAK RIS 2010 System, the “Query all accession number” field must be blank.
If the HIS/RIS returns a blank worklist, try leaving the “Query all patient ID, accession number” and “Patient Name”
field blank and try other “Query since” values.
To apply changes in the MWL/Query, the KODAK QC application must be turned off and re-started.

Configuring the DICOM Send Service


• “Send Files” interval: The interval between attempts to send accepted images.
• Retries: The number of times that the system will try to send the images.
• Source AE title: The title of the local station sending the images to PAC (optional).
• Failed Files interval: The time interval between attempts to send unsent images.
• “Send Files” timeout: The timeout to send an image to PACS (default 300 sec.).

Note
To apply changes in the “Dicom Send” screen, click [Dicom Service Stop] and then click [Start Service] to start the
Send Service again.

Managing Disk Space


Clear Images allows you to configure the system to automatically control the number of images that the system will
store by setting the High/Low watermarks (limits).
• Number of images on the disk: All DICOM images, both accepted and rejected.
• Number of unprocessed images: Only images stored in the Archive folder.

Note
To apply changes, click [Save].

30 6H1307 – 20MAY09
Configuring Customer Information
[1] Select Setting>Setup>DICOM Settings.
[2] Configure:
• Institution name
• Manufacturer
• Manufacturer model name
• Station name (the name that will appear on the PACS to identify where the image came from)

See Configuring the KODAK QC High/Low Database Limits on Page 52 for information about the Clear Images
configuration.
[3] Click [Save].

20MAY09 – 6H1307 31
Configuring a PACS Station
[1] Click the Destinations tab.

[2] Fill in the “DICOM Store Destination” details.

[3] Click [Add].


[4] Click [Save].
[5] Select the default check box to activate the auto-send feature.

Note
“Storage Commitment” is normally blank.
If a Storage Commitment service is available in the hospital PACS system, press on the Add/Update button to
activate this data dialog, then fill in the details using the virtual keyboard and then press [].
[6] Click [Dicom Service Stop].
[7] Click [Start Service] to start the Send Service again.

32 6H1307 – 20MAY09
Configuring a DICOM Printer
Configuring a DICOM Printer with KODAK Quality Control Software for Point-of-Care CR
Systems, Version 2.5.and Higher
Pre-requirements
Users must use the AddDicomPrinter Wizard program provided by the driver to install a DICOM printer locally.
A DICOM printer must be accessible on the network during the printer installation as the AddDicomPrinter Wizard
queries the printer for information before loading the appropriate driver for the printer.
Multiple installations of the DICOM Printer Driver application on the same system are not allowed. If attempted, the
Installer will simply replace the previous installation. To un-install a version of the MICROSOFT WINDOWS DICOM
Printer Driver from a workstation:
• Select Control Panel>Add/Remove Programs>Kodak DICOM Printer Driver.
• Click [Remove].
If local DICOM printers are installed, you must uninstall them. To remove all DICOM drivers:
• Select Printers and Faxes>File>Properties>Drivers.
• Click [Remove].
The Printer Driver installation process prompts for automatic start-up of the Add Printer Wizard and the Printer Status
Monitor when the installation is complete. The installation will create shortcuts for the driver’s “Add DICOM Printer
Wizard” and “DICOM Printer Status Monitor” programs under Eastman_Kodak>DICOM_Printer_Driver in the Start
Programs menu (see below).
Data that you will need to enter during the procedure: (see Step 6)
• Printer’s Internet address (IP)
• DICOM Application Entity title (AE)
• Printer’s port number

Adding a DICOM Printer


[1] Exit to the Desktop.
[2] Select Start>Programs>Eastman_Kodak>DICOM_Printer_Driver>Add_DICOM_Printer_Wizard.

Note
The Add DICOM Printer Wizard Screen appears.
[3] Click [Next].

20MAY09 – 6H1307 33
[4] Select “No, I don’t have a configuration file. I want to install a single printer interactively”.
[5] Click [Next].

[6] Enter the IP Address, AE Title and Port number.


[7] Click [Next].

[8] Select your printer type on the drop-down list.

34 6H1307 – 20MAY09
[9] Click [OK].
[10] Click [Install].

Note
The Install Wizard finds the correct driver and issues a warning message.
[11] Click [Continue Anyway].

[12] Click [Finish].

The system is ready for DICOM printing after a DICOM printer is successfully added. To find the printer information,
select Start>Setting>Printers and Faxes.
20MAY09 – 6H1307 35
It is recommended to configure the Image Quality for the Printer Type.
• For non-KODAK Printers, see Recommended Configuration for Non-KODAK Printers on Page 39.
• For KODAK Printers, see Recommended Configuration for KODAK Printers on Page 40.
[13] Click [Advanced].
[14] In the 12 Advanced Options screen, select the desired default paper size on the drop-down list.
[15] Click [OK].

[16] Select Paper Size.


[17] In the Properties main screen, select the Device Settings tab.
[18] Select the film cassette size on the drop-down list.
[19] Click [OK].

36 6H1307 – 20MAY09
[20] Select a Film Cassette size on the drop-down list.

Note
The selected Paper Size and Film Size must be identical.
[21] Click Blue Film Media Type.
[22] Click Advanced>Printing Preferences.

[23] On the Media>Paper drop-down list, select “Blue film” (for a DICOM Printer).
[24] Click [Apply].

Performing a Trial Print from the User Application


To perform a trial print, send an image from KODAK QC to the DICOM printer:
[1] Login to KODAK QC software.
[2] Open the Viewer.
[3] Click the Select Printer icon on the main toolbar to select the DICOM printer.

20MAY09 – 6H1307 37
[4] Select the film size in Print Composition pane.

[5] Click [Browse Database] to open the database.


[6] Select an image and print it. (See “Print an Image” in the Viewer section of the KODAK QC Version 2.5 User
Manual.)

[7] Check the printing results.


[8] In Printers and Faxes, right-click the icon of the printer you want to set as default printer.
[9] Set the default printer in the dialog box that appears.

38 6H1307 – 20MAY09
Recommended Configuration for Non-KODAK Printers
[1] Select Start>Settings>Printers and Faxes.
[2] Right-click the icon of the DICOM Printer that you added.
[3] Select Properties>Advanced>Printing Defaults.

[4] In the Printing Defaults property sheet, select “Paper/Quality”.


[5] Select “Blue film” on the Media tab drop-down list.

[6] In the DICOM configuration tab, set Border Density to “black”.


[7] In the DICOM configuration tab, set the Image Density Minimum to “21” and Maximum to “300”.

20MAY09 – 6H1307 39
Recommended Configuration for KODAK Printers
[1] Start the KODAK QC Software.
[2] Select Viewer>Settings>Image Adjustment.

[3] Browse to a DICOM image and select it.


[4] Click [Next].

40 6H1307 – 20MAY09
[5] Click [Next].

[6] Select the KODAK printer.


[7] Click [Next].

[8] Select the TFT file parameters from the list.


[9] Select “I know the parameters that I want to use. I don’t want to print test images.”
[10] Click [Next].

20MAY09 – 6H1307 41
[11] Select the TFT parameter “Wrkstn2a.w87”.
[12] Click [Next].

[13] Click [Next].

Note
Test images are printed.
[14] Select the number of the image with the best quality.
[15] Click [Next].

42 6H1307 – 20MAY09
[16] The printer configuration parameters appear. Record them for future use.
[17] Click [Finish] to exit the DICOM Image Adjustment Wizard or click [Next] to repeat the process for another image
source and/or printer.

Configuring Viewer Overlays


The Application Engineer or KeyOp normally does the following configuration.

Note
To open the Viewer you will need at least one study image.
[1] Select Viewer.
[2] Select Settings.
[3] Configure the setting in the Configure Overlays tab.

20MAY09 – 6H1307 43
Configuring X-ray Parameters
kV/mAs
Various parameters can be changed at the customer's request. The procedure is described here. For detailed
information, refer to the troubleshooting instructions.

Presetting after Switch-on The default is 70 kV/5.0 mAs. Use service program Pr.5 to modify the preferred
values or to activate the “last value function”.
Maximum kV/mAs Values The default is set to “Max.” Display readings and selection options depend on
the line voltage (see “Technical data” in the Operator
Manual). Use service program Pr. 6 to change.
Exposure Points The standard is 49 steps. Use service program Pr. 11 to change the value. It
can be changed to a minimum of 25 steps.
Sound Level of the The default is “bep 1” = quiet. The confirmation tone upon pressing the “Kv”,
Keyboard (beep) “mAs”, or collimator lamp keys is OFF. Use the
service program Pr. 13 to change.

Activating Service Programs


[1] De-energize the system.
[2] Remove the X-ray front cover and lift up the CPU (D916) board cover.
[3] Set the service switch SW2B to “Service Position 2” (PCB D916).
Top VIEW of D916 CPU

[4] Energize the system.

Note
“Pr. 1 ”appears on the user display.
[5] Use the “mAs+/mAs-” keys to select the required service program.
[6] Enter the required value: “bep 1”, “bep 2”, or “bep 3”.

Note
“bep 1” is the quietest.
[7] Leave the program with the collimator lamp key.

44 6H1307 – 20MAY09
[8] Set the service switch SW2B to “User position 1”.
[9] Press the reset button “SW3” (PC board D916).
[10] Check the new values in the user function.
[11] De-energize the system
[12] Reattach the upper cover.

Sending an SMPTE Image to the Printer


[1] Start the KODAK QC Software.
[2] Click [Viewer].
[3] Click [Open].
[4] Browse to C:\Program Files\Kodak\KodakQC\CR ITX 560\Mobile\Demo Images.
[5] Open the “SMPTE_35x43_Kodak1.dcm” image.

Note
The image will be viewed in the KODAK QC Viewer.

[6] Click the Printer icon to open the print screen.

20MAY09 – 6H1307 45
[7] Drag the SMPTE image to the Print Preview screen.
[8] Click [DICOM Print] to send the image to the DICOM printer.
[9] Verify that the image on the screen looks the same as the image printed from the DICOM printer.

Installing and Configuring the DAP


Installation
Note
DAP configuration has been done in the factory. This section is for information purposes only.
If the DAP is already installed, go to Configuring the USB to the COM Cable on Page 47.
[1] Insert the USB to COM cable installation CD to the CD ROM.
[2] Connect the USB to Com cable to the marked USB port in the computer. (See “Replacing the CR Scanner” in
the CR-ITX 560 Service Manual).

Note
A “Found New Hardware” message appears.
[3] Select “No, not this time”.
[4] Click [Next].

[5] Select “Installing from a specific location”.


[6] Click [Next].

[7] Select the option to search the driver from a CD.

46 6H1307 – 20MAY09
[8] Click [Finish].

[9] The system recognizes two components in this cable device and the “Found New Hardware” message appears
again. Repeat Step 4 to Step 8.

Configuring the USB to the COM Cable


[1] Exit to the Desktop.
[2] Right-click My Computer and select Manage.
[3] Select Device Manager>Ports (COM&LPT)>USB Port.

20MAY09 – 6H1307 47
[4] Write down the COM value where the cable was installed. (Our example is COM5.)
[5] Go to C:\ProgramFiles\Kodak\KodakQC\CR_ITX560\Grayling\Calib>OrexQC.ini (Notepad).
[6] Scroll down to “Grayling” and type in the DAP COM Port number. (Our example is COM5).

[7] Select File>Save and close the .ini file.


[8] Select KodakQC>Settings>Setup.
[9] Select the “Enable DAP” check box.
[10] Click [Save] and close the application.

48 6H1307 – 20MAY09
Clear Images Service
Perform Clear Images when Restarting the Imaging System
Note
Clear Images Service is configured automatically when the software was installed. The Clear Images Service only
needs to be created if you are having problems with the service or with the timing.
Use this procedure to add Clear Images Service to the Startup menu.
[1] Browse to C:\Program Files\Kodak\KodakQC \CR ITX560\ Mobile\Bin folder and select the
“ClearImages.exe” file, right click the mouse and create a shortcut to Desktop (a shortcut to the
“ClearImages.exe” file will now be available on the Desktop).
[2] Copy and paste the “ClearImages.exe” shortcut to C:\Documents and Settings\All Users\Start
Menu\Programs\Startup folder.

Creating the Clear Images Service in the Scheduled Tasks


Note
If the service already exists in the Scheduled Tasks screen then move directly to Steps 3 and 4.
[1] Select Start>Settings>Control Panel>Scheduled Tasks.
[2] Double-click the Add Scheduled tasks icon.

Note
The Scheduled Task Wizard starts.
[3] Click [Next].
[4] Click [Browse] and browse to “C:\Program Files\Kodak\KodakQC \CR ITX 560\Mobile \Bin” folder.

[5] Select the “Clear Images.exe” file.

20MAY09 – 6H1307 49
[6] Click [Open].

[7] Enter 10:00 PM as the Start time.


[8] Select “Every Day”.
[9] Enter today’s date as the Start date.
[10] Click [Next].

[11] Leave the Default Task name and select Daily.


[12] Click [Next].
[13] Do not enter a password.

50 6H1307 – 20MAY09
[14] Click [Next].

[15] Click [Finish].

[16] If the following error message appears, click [OK].

[17] Right-click the “Clear Images” task.


[18] Select Run.

20MAY09 – 6H1307 51
Configuring the KODAK QC High/Low Database Limits
Note
The KODAK QC Database is set to default values as shown below. This means that when the database reaches 600
images, the “ClearImages” routine will delete 100 images, lowering the amount from 600 to 500.

The values can be changed. Before you change the values, the “DICOM Send” service must be stopped and then
started again so that the changes will be saved.

Note
The X41 and X61 computers have different HD configuration systems for the following high/low watermarks:
• X41 computer– recommended low – 150, high -200
• X61 computer– recommended low – 200, high -250

Note
To maintain optimum computer performance, keep partition D at no more than 50%. Also, it is highly recommended
to always keep as much free space as possible on the hard drive.

52 6H1307 – 20MAY09
Section 6: Functional Tests

Multileaf Collimator Function

• Open the collimator completely.


• Check the function of the light buttons on the collimator.
• Check the manual collimations with the light on.
• The light switches off after approximately 20 seconds.
• Test the collimator light key on the control panel.

Exposure Release with High Voltage

If the DAP and/or remote control options are installed, they can be tested for proper functioning during the following
tests involving release of the X-ray radiation.
[1] Close the collimator.
[2] Set the display on the control panel to 60 kV/10mAs.

Note
The control panel display for “exposure circuit ready” must illuminate green.
[3] Set the exposure switch (S27) to “preparation”.

Note
After 2 seconds, the “exposure ready” acoustic signal must sound.
[4] Stop at “preparation” and hold.

Note
After about 15 seconds, “ERR 25” must appear on the display (preparation time without exposure).
[5] Acknowledge the error with the collimator light key on the control panel.
[6] Release an exposure.

Note
The radiation indicator lights up during the exposure and an acoustic signal sounds, then the “exposure circuit ready”
light goes out. The “exposure circuit ready” lights up again within 15 seconds.

20MAY09 – 6H1307 53
Manual Termination of an Exposure

The user must be able to cancel an exposure at any time.


[1] Set a midrange “kV” value (e.g., 70 kV) and the highest possible “mAs” value.
[2] Start an exposure and interrupt it immediately.

Note
The display reads “ERR 41” and short acoustic signals sound (exposure aborted).
[3] Acknowledge the error message with the collimator light key on the control panel.

Accessories
DAP

Measuring Device for Dose Area Product (Dose Area Product)


The DAP measuring device is used to measure the kerma area product (kerma = kinetic energy released in matter)
during an X-ray examination. It is primarily used to record the radiation dose that a patient has been exposed to. The
DAP is calibrated at the factory.
[1] Press the Test button on the DAP display.

Note
The displayed value must be in the range of 8.0 - 12.0 mGy2 (DAP resolution 0.01 mGym2). Otherwise, the DAP
measuring system has to be calibrated according to the “Replacement of Parts” instructions.
[2] Verify the function of the DAP measuring system by releasing an exposure.

Note
The display must show a measurement value.

Remote Control

[1] Adhere the remote control holder to the front right or left side.
[2] Test the “collimator light” and “exposure release” functions.

Final Activities
Note
For Installation in the USA, perform the DHHS tests now. See DHHS Tests on Page 65.

54 6H1307 – 20MAY09
Protective Conductor Test

Caution
Electrical Voltage
Tools required:
• Metron QA-ST Mk. II Safety Tester, 120 V AC - TL5954 or Fluke 175
• Metron QA-ST Mk. II Safety Tester, 230 V AC - TL5955
The purpose of the Protective Conductor Test is to ensure that any touchable conductive surface that an operator or
patient can touch is at proper ground potential.
The protective conductor resistance must be measured, documented, and evaluated during maintenance.

Note
For evaluation purposes, the first measured value and the values documented during maintenance or safety checks
must be compared to the previously measured values. A sudden or unexpected increase in the measured values
may indicate a defect in the protective conductor connections, even if the limit of 0.2 ohms is not exceeded (protective
conductor or contacts).
The protective conductor resistance for all touchable conductive parts must be measured during the normal operating
state of the system.
Make sure that control cables or data cables between the components of the system are not mistaken for protective
conductor connections.
During the measurement, move the power cable and additional connection cables with an integrated protective
conductor section by section to detect cable breaks.
The protective conductor resistance must not exceed 0.2 ohms.(200 milli-ohms).
Perform the protective conductor test with all covers closed.
The values determined, including the measuring points, must be recorded and assessed in the protective conductor
resistance report. (See Protective Conductor Resistance Report on Page 84).
The measuring device used (designation and serial number) must also be documented.

Note
A new report must be created if previous protective conductor resistance measurements are not documented.
Test Procedure
[1] Plug the safety tester into the mains power.
[2] Press the V (line voltage) button and record the incoming mains voltage. For the Fluke 175, select V-Lime Volts.
[3] Attach the Kelvin test lead to the enclosure connector of the tester. For the Fluke 175, attach TRST load to the
chassis connector.
[4] Plug the mains power connector of the CR-ITX 560 System into the tester. An electrical adapter may be required
(procure locally).

Note
For this test, the KODAK CR-ITX 560 can be on or off.
[5] Press the “Gnd Wire Res” [prot earth] on the tester.
• Press the “Gnd Wire Res” button on the safety tester, 120 V AC - TL5954.
• Press the “Prot Earth” button on the safety tester, 230 V AC - TL5955. For the Fluke 175, select - W -
Resistance

Note
The display will indicate over range 0L mW. The Fluke 175 displays “1”.
[6] Using the test probe, touch the CR-ITX 560 System potential equalizer post.

20MAY09 – 6H1307 55
[7] Record the resistance value reported on the Protective Conductor Resistance Report as Meas. Point 1.

Note
You may have to squeeze or press the contact surface. All measurements must be less than 0.2 W (200mW).
[8] Repeat Steps 5 - 7 for the remaining seven (7) points listed in this step and illustrated in the figure below; and
record in report as Meas. Points 2 - 8.

Item Description
1 Potential equalizer post
2 Screw, cover of bottom support arm
3 Screw, cover of top support arm
4 Screw, end cap
5 Single tank cover, screw
6 Screw, collimator
7 Left side cover, unpainted surface on the inside of the cover
8 Right side cover, unpainted surface on the inside of the cover

Protective Conductor Test Contact Points

[9] If this is not the initial Protective Conductor Resistance test, evaluate (compare) the values recorded in this test
against the previous recorded test values.

56 6H1307 – 20MAY09
[10] Record the following additional details on the report, and sign and date:
(a) Customer Name
(b) Serial Number
(c) K-number
(d) Name of Safety Tester
(e) Serial Number of tester
(f) Tester’s Calibration Due Date
(g) Sign and Date

Leakage Current Measurement


Tools required:
• Metron QA-ST Mk. II Safety Tester, 120 V AC - TL5954 or Fluke 175
• Metron QA-ST Mk. II Safety Tester, 230 V AC - TL5955
The purpose of the Leakage Current Test is to ensure that if a fault in the grounding circuit occurs, no lethal currents
are created. The Allowable Leakage Current is stated in ICC 60610-2-7, Section 19.3a, Table IV, Note 4.

Note
During maintenance, the leakage current measurement must be conducted and recorded as a repeat measurement.
However, the first measured value must be newly determined and a new report must be created under the following
conditions:
• Lack of documentation for leakage current measurement
• Deviation of the local line voltage from the line voltage documented in the report (e.g location change, operator
change)
• When a different procedure for measuring the leakage current than the one documented in the report is used
For the purposes of traceability, references to the new report must be written in the old report. The reason for newly
determining the first measured value must be documented and confirmed with a name and signature.

Caution
Electrical Voltage
• Non-compliance can lead to severe injury or even death.
• The leakage current measurement may be performed on systems of protection class I only after the protective
conductor test has been passed.
First Measured Value
The first measured value has already been determined and documented in the leakage current report. The
measuring procedure was also recorded. The measurement was performed with the recorded line voltage and with
recorded measuring equipment.
Measurement

Note
The system must be energized during measurement.
[1] Energize the system.
[2] Perform the measurement and record the determined value.
[3] Perform the test with all covers closed.
[4] Enter the highest value in the current leakage report

Note
This value must not exceed the permissible leakage current value of 2.5 mA.
[5] Measure and record the current line voltage.

20MAY09 – 6H1307 57
[6] If the measured line voltage deviates from the nominal voltage, correct the measured value to the value
corresponding to a measurement at the nominal value of the line voltage.
[7] Document the actions performed in Step 6.
[8] In case of repeat measurements, the measured value must also be evaluated.

Note
For evaluation purposes, the first measured value and the values documented during maintenance or safety checks
must be compared with the measured values. A sudden or unexpected increase in the measured values may indicate
that a fault has occurred in the primary power circuit (insulation damage, damage from moisture, defective
interference suppressor, etc.), even if the limit value of mA is not exceeded.
The evaluation is not necessary in the case of a new determination.

Note
A new report must be created if previous leakage current measurements are not available.

Test Procedure
[1] Plug the safety tester into the mains power. It may be necessary to use a mains adapter.
[2] Press the V (Line voltage) button and record the incoming mains voltage. For the Fluke 175, select V- line Volts.
[3] Plug the mains power connector of the CR-ITX 560 System into the tester. An electrical adapter may be required
(procure locally).

Note
For this test, the CR-ITX 560 System must be on.
[4] Turn on the CR-ITX 560 System. For the Fluke 175 - Set AAMI/IECEOL to IECEOL.
[5] Press the Leak Current mA Earth [Earth] button and record the value:
• Mktron - Press the Leak Current mA Earth [Earth] button.
• For the Fluke 175, select NA- Ground.
• TL5955 - Press the Earth Button.
[6] Press the Outlet Power button and record the value:
• Mktron - Press the Outlet Power - Rev Pol [Rev. M] button.
• For the Fluke 175 - outlet- Reverse.
[7] Press the Outlet Power button and record the value.
• TL5955 - Press the Outlet Power - Open Grd [Open E.] button.
• For the Fluke 175, press Open GND.
[8] Record the highest of the three (3) readings in the Leakage Current Report.

Note
The highest allowable current is 2.5mA (2,500 mA).
[9] If this is not the initial Leakage Current test, evaluate (compare) the values recorded in this test against the
previous recorded test values.
[10] Record the following additional details on the report and sign and date.
(a) Customer Name
(b) Serial Number
(c) K-number
(d) Name of Safety Tester
(e) Serial Number of tester
(f) Tester’s Calibration Due Date
(g) Sign and Date

58 6H1307 – 20MAY09
Gain Tuning Procedure
Introduction
The CR-ITX 560 System undergoes a tuning process before leaving the factory, but the system should be finely
tuned during installation in order to set the system to the nominal point of operation.

Note
Although this procedure is performed at the factory, please perform the PM-Gain Verification Procedure again and
make sure that the correct PM-Gain value is chosen from the CR Calibration Table.
If the ATP results are not in range, please perform the full Gain Tuning Procedure to reach optimal results.

PM-Gain Verification Procedure


[1] In the Calibration screen, select View Calibration Values.

Note
The “CR Calibration Table.txt” file opens.
[2] In the [4000-GL] column, locate the value that is closest to 137.0.

[3] Record the corresponding value in the PM Gain column (in the above example, the PM Gain is 111).
[4] Close the “CR Calibration Table.txt” file.
[5] Touch the Anatomical tab.
[6] On the Organ drop-down list, select “Organ”.
[7] In the Global PM Settings box, type the value found in the “CR Calibration Table.txt” file (“111” in the above
example file).

20MAY09 – 6H1307 59
[8] Select Set.

Note
The value is applied to all sub organs.
[9] Repeat steps 6-8 for all rooms and organs on the Organ drop-down list.
[10] When all rooms and organs are updated with the new PM-Gain Value, click [Apply] to exit the Setup window.
[11] For KODAK QC V2.5.1sp4 and above, select “Auto Gain Settings” in the Calibration screen.

Note
A message displays the PM-Gain setting.
[12] Click [OK].

Full Gain Tuning Procedure


Equipment Required
• General purpose 14 x 17 in. cassette
• 0.5 mm copper plate
• 1.0 mm aluminum plate
• Dosimeter
[1] Using the X-ray machine control panel, set the following X-ray settings: 81 kVp, 10.0 mAs, SID = 186 cm (72 in.).
[2] Add 0.5 mm Copper (above) and 1.0 mm Aluminum (below) plates at the tube exit.
[3] Position the dosimeter in the exposure field.
[4] Adjust the SID to get the required value of 2mR ±0.1mR (17.5 mG ±0.1 mG).

[5] Place a 14 by 17 in. cassette in the center of the field.


[6] Make an X-ray exposure.
[7] Wait 5 minutes after exposing the cassette.

60 6H1307 – 20MAY09
[8] Load the cassette.
[9] Click [Scan] to scan using the existing PM Gain value.
[10] Scan using Siwll>Pattern as the body part.
[11] Record the Pixel Value in the center of the field (place the mouse cursor on the center of the image).

Note
The Pixel Value is displayed on the right side beneath the Image Histogram.
[12] Change the PM Gain gain to get a pixel value of 3200 ± 100 by changing the PM gain value in the simulate PM
Gain.
• To increase the pixel value, decrease the PM Gain.
• To decrease the pixel value, increase the PM Gain.
[13] Click [Process] to apply the new value on the image.

[14] When the desired pixel value is reached, select the Save icon to save the new PM gain.
[15] In the Save Settings dialog box, select Save PM and Save to all organs.
[16] Click [OK].

20MAY09 – 6H1307 61
[17] Go to the Settings>Anatomical tab and check that the PM values are set to the value that you saved in the
above step.
[18] If the PM Value is not updated, type the value into the Global PM settings.
[19] Click [Set].

Half Layer, X-ray


Set up the system using the recommendations below:

Note
1.0ma AC/ 0.5 Ma Cu filters are not used.
[1] Using the X-ray machine control panel, set the following X-ray settings: 80 kVp, 20 mAs at 40 in. (100 cm).
[2] Place the X-ray measurement device in the beam.
If the measurement device is a UNFORS 302, 407, or Inovision, proceed to Step 4, otherwise go to Step 12.
[3] Make an exposure.
[4] Record the dose measured in the field for 0 mm.
[5] Add 2.5 mm of aluminum filtration in the beam path.
[6] Make an exposure.
[7] Record the dose measured in the field for 2.5 mm.
[8] Add 5.0 mm of aluminum filtration in the beam path.
[9] Make an exposure.
[10] Record the dose measurement in the field for 5.0 mm.
[11] Enter the dose values in the appropriate fields.
[12] Use exposure parameters listed and make one (1) exposure to determine HVL.

62 6H1307 – 20MAY09
Luminous Collimator
[1] Place the Light Meter TL5614 at an SID of 100 cm (40 in.).
[2] Turn off all the room lights.
[3] Measure the ambient light in the room and record.
[4] Adjust the field size to approximately 25 sq. cm (10 x 10 in.) and record the values.
[5] Turn on the collimator field lamp.

Note
Use TL5614 - light meter to measure the light in each of the four quadrants.
[6] Measure the light output in the approximate center of each quadrant and record the values.
• The Europe, Canada, and Australia requirement is 100 lux at 100 cm.
• The U.S. requirement is 160 lux at 100 cm.
[7] Adjust the light voltage on the D927 Power Board.Using P1.

SID Check
[1] Using the SID tape on the collimator, position the tube to a SID of 47 in. (120 cm).
[2] Use a tape measure and verify that the distance from the floor to the red dot on the front tube cover is 47 in.
(120 cm).

Focal Spot Size, X-ray


The actual X-ray focal spot is not provided. Use the nominal focal spot size (0.8) written on the X-ray tube. If the actual
measured focal spot size is required, contact your Service Engineer.

Light Field/Radiation Field

[1] Prepare a 14 x 17 in. cassette.


[2] Place the cassette on a suitable support.
[3] Set the SID to 72 in. (180 cm) (use the collimator’s tape measure).
[4] Align the light localizer to the cassette and collimate to about 25 x 25 cm (10 x 10 in.)
[5] Mark the four sides and one of the corners (e.g., with coins).

[6] Set the control panel to 55kV/ 2.5 mAs and release an exposure.
[7] Scan the cassette.
[8] Measure the deviation between the light field and the radiation field.
• The permitted deviation for Europe is ±1.7% of the SID.
• The permitted deviation for US is ±2.0% of the SID.

20MAY09 – 6H1307 63
[9] If the deviation is >1.7% (Europe) (>2.0% U.S.), the collimator must be adjusted using the Allen adjusting
screws. (See the “Replacement of Parts” instructions.)

Collimator Blade Alignment


[1] Turn off the room lights.
[2] Place the light meter at an SID of 40 in. (100 cm).
[3] Set the collimater to 25.5 cm sq. (10 x 10 in.).
[4] Measure the light box.
[5] Adjust the knobs to get a 10 x 10 in. box (25.5 x 25.5cm).

64 6H1307 – 20MAY09
Section 7: USA and European Test Procedures

DHHS Tests
Scope of validity: USA only
Checking the kV and mAs exposure parameters.

kV Accuracy
This procedure uses the Unfors 407L Radiation meter TL5417.

Note
The inherent filtration (Al equivalent) is 3.1 mm Al. This filtration value includes the single tank and collimator.
An installed DAP measurement chamber increases the inherent filtration by 0.4 mm Al.
[1] Prepare the Unfors meter to record the kV value.
[2] Place the meter on a suitable surface. It does not require a lead backing.
[3] Set the SID to 24 in. (60 cm.).
[4] Collimate the beam to the meter.
[5] Perform exposures at the kV/mAs values in the following chart and record the meter readings.

Exposure Settings KV Limits Recorded Value Pass/Fail


50 kV 50 mAs 49.0 - 55.0 kV
81 kV 20 mAs 77.0 - 85.0 kV
133 kV 12.5 mAs 126.4 - 139.6 kV

mAs Accuracy
This procedure uses the Fluke mAs 07-487 meter TL5419.
[1] Remove the X-ray tube covers.
[2] Remove the U-shaped mAs jumper D907 and connect the mAs meter leads. For the mAs meter TL5419 use
the DC connectors and connect red to mA+ and black to mA-.
[3] Energize the system.
[4] Perform exposures at the kV/mAs values in the following chart and record the meter reading.
[5] Check that the kV readings are within limits. Reset the meter between exposures.

Exposure Settings mAs Limits Recorded Value Pass/Fail


40 kV 5 mAs 4.7 - 5.3
81 kV 2 mAs 1.9 - 2.1
133 kV 10 mAs 9.5 - 10.5

[6] Remove the meter leads and re-install the mAs jumper D907.

20MAY09 – 6H1307 65
Reproducibility Test (USA only)
Requirement
The coefficient of variation for the radiation dose for any combination of exposure parameters does not exceed 0.045.
This requires operation at the line voltage compliant with Carestream Health specifications.
In the following test, 10 sequential exposures are taken within one hour.
The exposure parameters should be briefly set to different values following each measurement.
Required measuring instrument:
• Dosimeter

[1] After energizing the system, wait until its temperature has stabilized.

Note
The system is ready for these measurements after 15 minutes.
[2] Initiate the number of exposures with the specified exposure data: 85 kV, 1.0 mAs, 10 exposures.
[3] Measure the dose for each exposure.
[4] Reset the display prior to each new measurement.
[5] Calculations: Coefficient of variation C. The coefficient of variation C is determined for a series of 10 dose
measurements with the following formula:

• s = Standard deviation resulting from measurement


• X = Average measurement of the series
• Xi = i. measurements of series
• n = Number of individual measurements in series
The following shows an example of the procedure. Follow this protocol and record the result of the protocol.
The coefficient of variation C must be <0.045.
If the value obtained is >0.045, locate and correct the cause according to the Troubleshooting instructions.
QSQ Determine coefficient of variation C.

66 6H1307 – 20MAY09
Example for determining coefficient of variation C:
1. 10 exposures with recorded measurements (fictitious measured values) (see the table below).
2. Addition of measured values.
3. Calculation of standard deviation.
4. Calculation of the coefficient.
In this example, the generator complies with the specification C = 0.0105; hence, it is <0.0450.

Example of 10 Exposures with Recorded Measurements:


Exposure (n=10) Measured values (xi)
1 1.01
2 1.02
3 1.03
4 1.04
5 1.03
6 1.02
7 1.02
8 1.01
9 1.03
10 1.04

20MAY09 – 6H1307 67
Test Procedure for Low Dose Images (German Prufung DIN 6868-58)
Germany Installation Only

Background
The German authorities conduct Prufung tests on a periodic basis on CR medical units.
The system is required to pass the test in order to be used in clinical processes.
The test provided in this document is intended to ensure that the tested systems will pass the German Prufung test.

Preliminary X-ray Requirements


A 14 x 14 in. exposed area must be verified for uniform exposure level of 20% at 3.5 ìGy +0.2/-0.0 ìGy

Required Items
• German Phantom: DIN 6868-13 (DIGI-13)
• Calibrated dosimeter
• Body equivalent, 25 mm thick, Aluminum plate
• 14 x 17 in. cassette, with KODAK GP screen

Reader Setup
• Select the 14 x 17 in. HRP cassette holder for this scan.
• Set PMG value that insures average pixel value of 3750 ± 50 on the background.
• Use “No Correction” with this test.

Test Procedures

X-ray Dose Adjustment


[1] Using the X-ray machine control panel, set the following X-ray settings: 70kVp, 32mAs, and SFS.
[2] Slide the X-ray source head to have a SID=127cm (distance from X-ray source to the dosimeter plane).
[3] Place the dosimeter at the beam center and the phantom on the dosimeter.
[4] Place the Aluminum plate (body equivalent) at the X-ray collimator window, as shown in the diagram below.

[5] Execute the exposure measurement.


[6] Verify that the dose is in the range of 3.5 mGy to 3.7 mGy.
[7] Remove the dosimeter when the dose requirement is met.
68 6H1307 – 20MAY09
Phantom Exposure and Scan
[1] Slide the aluminum plate out of the collimator window.
[2] Place the cassette, loaded with freshly-erased plate, on the table, with its center located at the X-ray beam
center.
[3] Place the DIGI-13 phantom directly in contact with the cassette and with its center cross located at the cassette
center.
[4] Slide back the Al plate to cover the collimator window.
[5] Expose the Cassette-Phantom setup to X-ray radiation.
[6] Verify that the scanner is in no-correction scanning setup.
[7] Scan the plate using the 14 x 17 in. HRP holder.
[8] Display the image with window leveling feature, making sure that all gray levels of the step phantom are
visible simultaneously.

Final Test Procedure


Using the following measurements, fill in the matching fields on the Prufung Test Results Form on Page 87.
[1] Visual Resolution: You should see at least 2.4 lp/mm (lines should be continuous).

Note
For reference: DIN requirement - 2.4 lp/mm for 5 mGy and 2.8 lp/mm for 10 mGy.
[2] Contrast Resolution:
a. You should see all seven gray steps of the phantom. You should see that they are differentiable and go
from white to black.
b. You should see the four low contrast discs adjacent to the resolution pattern. For reference: at least 3 low
contrast discs must be completely visible.
[3] Artifacts: No artifacts should appear. This includes dust, scratches, missing lines and pixels, interference, and
moiré patterns. Noise patterns due to filtering operations are also considered artifacts and should be avoided.

Final Test Procedure


Prufung Test Results

20MAY09 – 6H1307 69
Section 8: Performance Image Quality Verification of CR-ITX 560
Medical Systems (ATP)

Introduction
This document describes methods and procedures to test the performance of CR-ITX 560 systems. The acceptance
testing ensures the system is functioning in accordance with the design and specifications when it was manufactured.
Quality control ensures that the system performance has not degraded with time. Both acceptance testing and quality
control testing provide a rigorous means of assuring the consistent image quality that CR-ITX 560 systems are
capable of delivering.

List of Equipment Required for Testing


The following tools are required to complete the testing described in this document.
• Calibrated dose-meter
– Dose range from <0.1 mR to > 10 mR>
– Precision 5%
• Low contrast phantom (Low Contrast Testing Tool)
• Pair of spatial resolution test patterns (Model 07-256)
• Pair of rectangular plates: 0.5mm Copper and 1.0 mm Aluminum (for X-ray filtration)
• Lead sheet or lead apron (use the lead apron through the entire testing process to avoid backscatter)
Estimated time for conducting the complete set of tests: 2 hours

List of Tests
The CR-ITX 560 System performance evaluation and image quality inspection process consists of the following tests:
[1] Physical Inspection and Inventory
[2] Dark Noise
[3] Signal Response
[4] Visual Artifacts Inspection
[5] Erasure Thoroughness
[6] Spatial Resolution
[7] Low Contrast Resolution

Before Starting the Tests


These ATP procedures should be conducted using the WIISE Tool viewer with the Raw image. (Image from the.../
Images/Ar folder). Refer to Appendix A - WIISE Tool on Page 90.
Select the Exposure index value (Q number) Display tag in the Settings>User tab.
For the System Response test to return the Exposure Index (EI) value in the Q-val field, Kodak Processing with
Eclipse must be enabled.

70 6H1307 – 20MAY09
Acceptance Tests
1. Physical Inspection and Inventory
• Verify that you have the correct number of cassettes of each type and size.
• Each cassette should be visually examined for external defects.
• Each cassette should be opened and the screen extracted to inspect for dust or scratches.

2. Dark Noise
Purpose
Estimation of the noise level inherent in the system.

Procedure
[1] Use a well-erased 14 x 17 in. screen.
[2] Read the screen, without exposing it, using the following reader parameters:
• Image processing mode: No-Correction
• PM gain: nominal (for calibrating system)
[3] Use ROI tool to select a center area within a flat field.
[4] Record the following parameters:
• The average pixel value (APV) = Avg
• The maximum pixel value (MaxPV) = the second value in the Range
• The standard deviation (PVSD) = Std Dev
[5] Record the results in the form given in ATP Report A, test #2.

3. Erasure Thoroughness
Purpose
Test the residual signal remains on a screen after readout and erasure.

Procedure
[1] Position a CR cassette below the source SID = 72 in. (180 cm).
[2] Position a rectangular thick metal (e.g., Al) block at the center of the CR cassette.
[3] Expose the screen to 60kVp, 40mAs, and without filtration.
[4] Read the screen.
[5] After an erasure cycle, make a second exposure at 60 kVp and 2mAs.
[6] Set a very narrow window and adjust the level.
[7] Visually inspect the image for any remnant of the previous image.
[8] Verify that no evidence of a ghost image is found when the entire image is visually inspected.
[9] Record the results in the form given in ATP Report A, test #5.

20MAY09 – 6H1307 71
4. Spatial Resolution
Purpose
Measure the spatial frequency response of the system to provide sharp image. The spatial frequency response is
usually derived from the modulation transfer function (MTF). Since the tool for MTF measurement can be found
usually only in research labs, the spatial frequency response is measured using a grid pattern phantom.

Procedure
[1] In the Anatomical screen create a body part called spatial reso under the “Skull” organ using the following
settings: Body Part - Patterns, 60 kVp, 7.5 mAs, SID = 72 in. (180 cm).
[2] In the scan window, select the Skull>Spatial Reso body part.
[3] Place 14 x 17 in. cassette at SID = 72 in. (180 cm).
[4] Place 2 resolution test patterns: one along the scan direction and the other along the sub-scan direction.

Note
No filters are used in this test.
[5] Collimate the beam to the phantom area (using the collimator shutters).
[6] Expose the cassette to 60 kVp and 6.3 mAs.
[7] Verify the exposure level of 53µGy (±3µGy), 6 mR (±0.5 mR) on the plate.
[8] Expose the cassette.
[9] Verify that the image processing mode is “No-Correction”.
[10] Read the screen.
[11] Set the viewer window magnification of 200%.
[12] Adjust the window width and level for the image. The window level should be set to maximize the visibility of the
line-pair pattern.
[13] Record the highest frequency line-pair pattern that shows visible modulation.
• Use the magnification, window width, and window level controls to maximize visibility of the line patterns.
• Note that as Nyquist frequency is approached, moiré effects will cause line-pair patterns to disappear and
reappear along the length of the pattern. Because of this effect, pattern should be considered as visualized
as long as some modulation is visualized on part of the length of the pattern.
[14] Repeat this procedure for 10 x 12 in.
[15] Record the results for both resolutions in the form given in ATP Report A, test #6.

5. Low Contrast Resolution


Purpose
Test the low contrast resolution limit of the system.

Procedure
[1] Use the low contrast phantom image shown in the figure below.
Low Contrast Phantom Image

[2] Set the following X-ray settings: 81 kVp, 4 mAs, SID = 78 in. (200 cm), filtration: 1 mm Al and 0.5 mm Cu.
[3] Expose the 14 x 17 in. cassette and screen.
[4] Verify that the exposure level on plate is on the order of 5 µGy (± 0.1 µGy), [0.6 mR] (± 0.2 mR).

72 6H1307 – 20MAY09
[5] Verify that the image processing mode is “No-Correction”.
[6] Inspect and count the number of the visible low contrast discs on the phantom image.
[7] Record the results in the form given in ATP Report A, test #7.

6. System Response
Purpose
Test the system response and exposure index. Kodak Processing with Eclipse must be enabled.

Note
The Exposure Index Value (Q Number) tag must be selected in Settings>User>Display Tags.

Procedure
[1] Select “Kodak process” as the Image>Data correction selection in the Settings>Setup tab.
[2] Verify that “Eclipse” is selected.
[3] Set the following X-ray settings: 81kVp, filtration: 1 mm Al and 0.5 mm Cu.
[4] Set the following exposure level: 2.0 [mR] (± 0.1 mR) or 17.5 µGy (± 0.1 µGy).

Note
Estimated mAs: 9.0 mAs
[5] Position the X-ray tube at SID ~ 72 in. (186 cm).
[6] Adjust the collimator to produce an X-ray field that fits a 14 x 17 in. image screen.
[7] Place the dosimeter centered in the X-ray field.
[8] Add the Cu and Al filters to the tube/collimator exit with copper plate close to the tube.
[9] Verify the exposure level of 2 mR (17.5 µGy).
[10] Adjust the SID to get exposure level closer to the levels mentioned in step 2 (adjustment range +10 cm).
[11] Make 10 exposure measurements to verify the 2mR level and compute the average level.
[12] Remove the dosimeter and place the cassette.
[13] Expose the 14 x 17 in. screen to produce flat field.
[14] Use a 5 minute time delay between the exposure and the reading.
[15] Read the screen at the following scanner setting:
• Data correction method: Kodak Processing
[16] Record the average exposure (in mR or µGy) measurements.
[17] Record the Q-val number that is displayed as tag on the image in the scan window as the Exposure Index value.
[18] Use the ROI tool in WIISE and select a central area within the flat field.
[19] Record the average code value (Avg).
[20] Record the results in the form given in ATP Report A, test #3.

20MAY09 – 6H1307 73
7. Artifacts
Purpose
In CR as in all imaging, image artifacts can degrade diagnostic quality. The purpose of this test is to inspect the image
uniformity using “flat field” exposure and to perform artifacts visual inspection. Uniform exposures provide a stringent
test for many common image artifacts that can occur in CR systems.

Procedure
For this test, use the uniform image resulting from 2-mR (17.5 µGy) exposure that was produced in the “System
Response” test:
[1] Visually examine the image for uniformity and artifacts.
[2] Examine the images for low contrast dark or light bands or streaks running in either the horizontal or vertical
directions.
[3] If streaks or bands are observed, measure and record the average pixel value along the darkest and lightest
bands.
[4] Verify that the image is free from any artifacts.
[5] Record the results in the form given in ATP Report A, test #4.

8. Return the Image Data Correction to KODAK Processing


Purpose
Reset the system back to normal image processing.

Procedure
[1] Select “Kodak process” as the Image>Data correction selection in the Settings>Setup tab.
[2] Verify that “Eclipse” is selected.
KODAK Process Check Box

74 6H1307 – 20MAY09
Recommended Testing Frequency
Acceptance Testing
Perform all the tests as described above.

Quality Control Testing

Yearly Complete acceptance test.


Monthly Visually inspect all screens for dust and scratches.
Weekly Erase all unused cassettes.

Gain Tuning and Verification Process


Background
CR-ITX 560 Systems undergo Calibration and Tuning procedures before leaving the factory ports. The system is
tuned using a flat field exposed at 2mR.
The Gain of the system is tuned to produce an Average Pixel Value (APV) of 3200 ±50 counts.
This procedure is intended to set the PM Gain to the target APV.

Required Equipment
• System: CR-ITX 560
• Software: KODAK QC 2.5.1 or later
• General purpose cassette 14 x 17 in.
• Filters: 0.5 mm Copper (Cu) and 1.0 mm Aluminum (Al)
• Lead sheet or apron (for exposure measurement)
• Dosimeter

Gain Verification
Repeat Gain Tuning Procedure on Page 59.

Cleaning the Storage Phosphor Screens


Storage phosphor screens should be inspected and if necessary cleaned on a regular basis. Contact with water
should be minimized. The overcoat on storage phosphor screens does not have abrasion resistance. Technologists
who are familiar with handling and cleaning KODAK Lanex screens must be aware that similar handling of storage
phosphor screens may lead to irreparable damage. Following is a useful cleaning protocol:
[1] If the screen has become soiled to the point where objectionable minus density spots are observed in images,
the screen should first be gently wiped with a dry, lint-free, soft cloth. Most minus density artifacts are caused
by loosely adhered dirt and a gentle wipe is all that is needed.
[2] For more strongly adhered soil, gentle cleaning with a lint-free, soft cloth, moistened (not soaked) with KODAK
antistatic screen cleaner should remove the soil. Do not scrub the screen. The overcoat’s protection is vital to
the screen function. After the soil is removed, immediately gently wipe the screen with a dry, lint-free, soft cloth.
Minimizing the amount of screen cleaner used and gentle wiping are the keys to good cleaning.
[3] Where stubborn soil is present, you may need to use isopropanol to clean the screen in the same way as
instructed in Step 2.
[4] Stains that do not respond to Steps 1-3 will probably result in screen damage if excess force is used to remove
them.

20MAY09 – 6H1307 75
Section 9: Backing Up the Configuration
It is good practice to back up the configuration data.
• Export the Scanner setting to the D:\Backup folder.
• Export the Anatomy setting to the D:\Backup folder.

Note
To back up the following information, write down the setting or do a screen capture and save it in the D:\Backup
folder.
[1] Back up the Admin settings by writing in the User Names and their Technical Level. (You cannot back up their
passwords.
[2] Back up the User settings.
[3] Back up the Setup settings.
[4] Do screen captures or copy the C:\ Program Files\Kodak\KodakQC\CRITX560\Grayling\Calib\DICOM.ini file to
the D:\Backup folder.
[5] Back up the Viewer Settings: Settings>Backup Settings.
[6] Back up the Annotation Tool by writing down the values or doing screen captures.

76 6H1307 – 20MAY09
Section 10: Creating and Restoring Ghost Images

Ghost imaging
The laptop computer is equipped with a CD-ROM called X41 Recovery or X61 Recovery which is in the CD
compartment of the laptop. SYMANTEC Ghost software is able to perform two functions:
• Initiate a full recovery of the software (reinstallation and activation). This option is explained below.
• Create the Ghost image. Make a complete copy of the installed software that is saved as a ghost file for backup.

Creating a Ghost Image


[1] Connect a USB keyboard to the USB port next to the Start Computer button.
[2] Energize the computer.
[3] As the computer is energizing, press the F12 key repeatedly until the Boot Menu appears.
[4] Select “ATAPI CDO” in order to boot from the CD.

[5] Select Option 2, “Run Norton Ghost”.

Note
The SYMANTEC Ghost software starts automatically.
[6] Click [OK] to enter the application.

[7] Select Local>Partition>To Image.

20MAY09 – 6H1307 77
[8] Select the hard drive designated as Drive 1.
[9] Click [OK].

[10] Select the partition.


[11] Click [OK].

[12] Select the “1:2 [New Volume] NTFS Drive>Ghost Backup” folder as the destination for the image ghost.
[13] Type the date of the Ghost in the File Name field.
[14] Click [Save].

78 6H1307 – 20MAY09
[15] If you get a message that there is not enough space for the data on the drive, click [High].

[16] Click [Yes] to start the Ghost procedure.

[17] When a message appears, click [Continue].


[18] Press and hold the Start button until the computer shuts down.
[19] Restart the computer.

20MAY09 – 6H1307 79
Restoring a Ghost
[1] Connect a USB keyboard to the USB port next to the Start Computer button.
[2] Energize the computer.
[3] As the computer is energizing, press the F12 key repeatedly until the Boot Menu appears.
[4] Select “ATAPI CDO” in order to boot from the CD.

[5] Select Option 2, “Run Norton Ghost”.

Note
Do not select “Full Recovery”.
[6] Click [OK].

[7] Select Local>Partition>From Image.

80 6H1307 – 20MAY09
[8] In the Look in window, select the “D:\Ghost Backup” folder.

Note
You might have more than one Ghost backup file. For example, you could have a factory setup file and another copy
that was made at a later date.
Do not use the factory or full ghost. Use the Ghost file created during installation or the ghost image that starts with
SNxxxxxx. xxx is the serial number of the scanner.

[9] Click [OK] to confirm the Source Partition file.

[10] Select an installment destination drive.


20MAY09 – 6H1307 81
[11] Click [OK].

[12] Click [OK] to confirm the installment Target Partition.

[13] Click [Yes].

[14] When you get a message asking to restart the computer, click [Restart].

82 6H1307 – 20MAY09
Section 11: Reports

Start-up Report CR-ITX 560 System


This protocol confirms operability according to the data sheet. The original document remains with the system.
Customer:.................................................................
Serial Number................................................K-number................................................

Check Control point Additional information


p Required documents complete
p Visual inspection
p Cable winch
p Support arm movement
p Single arm and collimator movements
p Identification
p Line voltage V
p Operating Elements and Displays
p Multileaf collimator function
p Exposure release with high voltage
p Light field/radiation field Deviation < + 1.7% Europe (2.0% U.S.)
Programming service programs
p kV/mAs display with system “ON” (Pr.5) ______kV______mAs or
“Last value - function” p
p kV/mAs maximum values (Pr.6) ____kV_____mAs
p Exposure points (Pr.11) 25 ____/_____49
p AUTO OFF (Pr.10 only) N.A.
p Sound level of the keyboard (Pr 13) bep____
Accessories
p DAP Display_______µ Gym2
p Remote control
Final Activities
p Protective conductor test (Measurement values in separate protective conductor resistance
report).
p Leakage current report (Measurement values in separate leakage current report)
Name____________________________________
Date_________________ Signature_______________
Note
To complete the Installation Report electronically, use the HG-DR (Health Group - Digital Radiology) Acceptance
Compliance Test (a MICROSOFT EXCEL file) Form V 5.05 or higher.

20MAY09 – 6H1307 83
Protective Conductor Resistance Report

Protective Conductor Resistance Report


CR-ITX 560 System
Customer
Serial Number
K-number

Protective Conductor Resistance


First measured value Repeat Measurement Values
Measurement point 1:
Measurement point 2:
Measurement point 3:
Measurement point 4:
Measurement point 5:
Measurement point 6:
Measurement point 7:
Measurement point 8:
Measure Circuit
Measuring Device Type:
Measuring Device Service Number
Measuring inst. calibrated up to:
Evaluation:
Date:
Name:
Signature:

84 6H1307 – 20MAY09
Leakage Current Report

Leakage Current Report


CR-ITX 560 System
Customer
Serial Number
K-number

Leakage Current
First Measured Value Repeat Measurement Values
Leakage Current (Highest measured
value) [mA]
Line voltage during the measurement
[V~]
Measuring Device
Measuring Device Type: Differential
Measuring Device Service Number
Measuring inst. calibrated up to:
Evaluation:
Date:
Name:
Signature:

20MAY09 – 6H1307 85
DHHS report (USA only)
The original document remains with the system.

DHHS Report
CR-ITX 560 System
Customer
Serial Number
K-number

kV accuracy
Check Control Point Check Value Additional Information
52 kV / 50 mAs ___________ kV Measuring Instrument:
________________________
81 kV / 20 mAs ___________ kV Serial no.:
________________________
133 kV / 12.5 mAs ___________ kV Date of Calibration:
________________________
mAs accuracy
40 kV / 5 mAs ___________ mAs Measuring Instrument:
________________________
81 kV / 2 mAs ___________ mAs Serial no.:
________________________
133 kV / 10 mAs ___________ mAs Date of Calibration:
________________________
Reproducibility
Dose measurement Min/Max Measuring Instrument:
deviation:____________ ________________________
Serial no.:
________________________
Date of Calibration:
________________________
Name:
Date:
Signature:

86 6H1307 – 20MAY09
Prufung Test Results Form

20MAY09 – 6H1307 87
Acceptance Test Procedure (ATP) for CR-ITX 560 System
Perform the ATP Procedure and record the results in the ATP Chart.

ATP Test Results Reporting


CR-ITX 560 System
Customer:
Machine Serial Number:
K-number:
Software Version:
Date:
Tested by:
Signature:

Test Results
Parameter Actual Requirement Units
1. Physical Inspection All items in proper
condition.
2. Dark Noise APV>3994
Max PV<4094
PVSD<2.5
3. System Response APV - 3000±100
El -2300±100
4. Artifacts
Scratches: No
Line Shifts: No
Missing Pixels: No
5. Erasure Quality No ghost image
6. Spatial Resolution 14 x 17 2.8 LP/mm
10 x 12 4.2 LP/mm
7. Low Contrast Resolution < or = 4 Number of visible discs

To be filled

88 6H1307 – 20MAY09
FDA Form 2579 (USA only)
FDA Form 2579

20MAY09 – 6H1307 89
Section 12: Appendix A - WIISE Tool

WIISE Tool

Dark Noise Values


Obtain the Average/Maximum/Standard Deviation Pixel values.
[1] Double-click the WISSE icon on the Desktop to start the WISSE Software.

[2] Open the Dark Noise image located at D:\Images\AR\Name of image.


[3] Right-click on the image, then select Analysis>Region of Interest.
[4] Left-click on the image and create a square in the desired area on the image.
[5] Record the following values:
(a) Average Pixel value (APV) = Avg value
(b) Maximum Pixel value (MaxPV) = the second value in the range
(c) Standard Deviation (PVSD) = Std Dev

System Response
To obtain the Exposure Index:
[1] Select Settings>User Tab>Exposure Index Number (Q number).
[2] Scan the image and record the Q-no. value displayed on the image.

90 6H1307 – 20MAY09
To obtain the Average Code value:
[1] Select WIISE>System Response image.

Note
Do not perform Window/Leveling.
[2] Select Analysis>Region of Interest.
[3] Right-click on the image, then select Analysis>Region of Interest.
[4] Left-click on the image and create a square in the middle of the image.
[5] Record the following value: Average Pixel value (APV) = Avg value.

Spatial Resolution

To obtain the Spatial Resolution


[1] Start the WIISE Software
[2] Open the test image.
[3] Right-click the image and select Processing Manager>Window Level.

Note
The Window-Level, 10_12 Spatial Resolution appears on the screen.
[4] Use the Window and Level sliders to set the window level manually.
[5] Zoom in on the Resolution Target.
[6] Right-click the image.
[7] Record the smallest triple-line set.

20MAY09 – 6H1307 91
Section 13: Publication History

Publication Publication ECO Changed


Date No. No. Pages File Name Notes
10JAN08 6H1307 C00311 All CR-ITX_560_System Installation New Publication
21DEC08 6H1307-01 C00629 21-78, 44- CR-ITX_560_System Installation Changes to the installation
45, 49, 21, procedure sequence
60 (pages 21-78)
Addition of a new chapter
on printer overlay
configuration (pages 44-
45)
Addition of a sub chapter
configure viewer overlays
(page 49)
Addition of a note (page
21)
Addition of a note (page
60)
20MAY09 6H1307 All CR-ITX_560_System Installation Changed and reformatted
document.

The Kodak trademark and trade dress are used under license from Kodak.

Printed in U.S.A. • 6H1307

Carestream Health, Inc.


150 Verona Street
Rochester, NY 14608

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