Kodak DirectView CR 800 and CR 900 Series User’s Guide June 2003

Table of Contents

1 Safety and Related Information Health and Safety Compliance ...1-7 CR 800/900 Systems...1-7 CR 850/950 Systems...1-8 Remote Operations Panel...1-9 User Guide Conventions ...1-10 Special Messages...1-10 2 Overview Product Description ...2-1 CR 800/850 System Components...2-2 CR 900/950 System Components...2-3 Touch Screen Monitor ...2-4 Internal PC...2-4 Cassettes ...2-4 Remote Operations Panel...2-5 Site Operating Configurations...2-5 Network Configuration ...2-5 Workflow ...2-7 Workflow Definitions ...2-7 Workflow Diagram...2-8 3 Operation and Main Menu Starting the CR System...3-1 Logging on to the Operator Console (Option) ...3-2 Changing your Password ...3-2 Shutting down the CR System...3-2 Rebooting the System ...3-3 Power Failures ...3-4 Operating Modes...3-4 Pass-through Mode ...3-4 QA Mode...3-4 Main Menu...3-5

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Main Menu Functions...3-5 Main Menu Screen Navigation Buttons ...3-6 Using the Touch Screen...3-7 Navigation Buttons ...3-7 Error Messages ...3-7 Virtual Keyboards ...3-8 Standard Alphanumeric Virtual Keyboard...3-8 Standard Numeric Virtual Datepad ...3-9 Special Keyboards ...3-9 Entering Information into Data Fields...3-10 4 Exam Data Entry Manual Data Entry...4-1 Entering Patient Information ...4-3 New Patient ...4-3 Trauma Patient...4-4 Existing Patient...4-4 New Study ...4-6 Entering Exam Information ...4-7 Using Procedure Codes and Procedure Mapping...4-7 Mandatory Exam Information...4-8 Optional Exam Information...4-9 Saving the Patient and Exam Information ...4-10 5 Scanning, Viewing and Printing Images Performing an Exam ...5-1 Loading Cassettes ...5-3 CR 800/850 System ...5-3 CR 900 System ...5-4 CR 950 System ...5-6 Viewing Images ...5-7 Viewing an Image in Pass-through Mode...5-7 Viewing Images in QA Mode...5-7 Working with Images ...5-10 Reprocessing Images ...5-10 Routing Images ...5-10 Erasing Screens...5-11 Reviewing Images...5-13 Managing Images ...5-15 Managing Failed Delivery Images ...5-16 Managing Unassigned Images...5-16 Printing Images...5-18 ii

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Printing Multi-format Images... 5-21 Other Multi-format Settings... 5-25 Multi-format Only Check Box... 5-25 Image Review Screen... 5-25 Deleting Multi-format Images ... 5-26 Printing Text... 5-26 Printing Internal Text Boxes ... 5-27 Printing External Text Boxes... 5-28 True-size Printing (Option) ... 5-29 1 cm Tick Marks ... 5-31 6 Maintaining Image Quality Guidelines for Optimizing Image Quality... 6-1 Performing the Exam... 6-1 Image Processing ... 6-1 Changing Image Orientation ... 6-2 Adjusting Contrast and Brightness... 6-2 Changing Window Widths (Contrast) ... 6-2 Changing Window Levels (Brightness)... 6-2 Changing Image Tonescale ... 6-3 Image Processing ... 6-4 Improving Image Characteristics ... 6-7 7 Troubleshooting Error Messages... 7-1 Releasing Cassette Jams ... 7-1 System Reset... 7-1 System Status ... 7-2 Clear Pending Images ... 7-2 Slow System Response ... 7-2 Incorrect Image Grouping ... 7-2 Modifying Patient Information ... 7-3 8 Maintaining Equipment and Cassettes Cleaning the CR System Surfaces... 8-1 Cleaning the ROP Touch Screen... 8-1 Cleaning Storage Phosphor Screens... 8-2 Special Cleaning Materials ... 8-2 Removing the Phosphor Screen ... 8-2 Cleaning the Phosphor Screen ... 8-3 Replacing the Phosphor Screen ... 8-4 Cassette Cautions ... 8-5 June 3, 2003

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Cleaning Cassettes ...8-6 Replacing Erase Lamps ...8-7 9 Key Operator Functions Introduction...9-1 Managing Patient Exam Records ...9-3 Statistics...9-5 Cassette Statistics...9-5 Destination Statistics ...9-6 Technologist Statistics ...9-7 Scan Cycles ...9-9 Destination Status Summary ...9-10 System Configuration...9-11 Saving System Configurations ...9-14 Restoring Configurations...9-14 Option Registration ...9-16 Workflow Optimization ...9-17 Changing Button Names, Colors, and Position ...9-18 Changing Button Names ...9-18 Changing Button Colors...9-18 Changing Button Location ...9-19 Body Part and Projection Configuration ...9-20 Department and Physician List Configuration ...9-21 Procedure List and Procedure Mapping Overview ...9-23 Procedure List Configuration...9-23 Procedure Mapping (Option) ...9-24 Procedure Mapping on the CR System...9-25 Using an Existing Procedure to Create a New Procedure ...9-26 Mapping more than 34 Procedures...9-26 Editing Procedure Codes and Names...9-27 Using a HIS/RIS System ...9-27 Deleting a Procedure ...9-27 Procedure Mapping Using the Remote Key Operator ...9-28 Adding a New Procedure ...9-28 Locating Procedures ...9-30 Editing Procedures...9-30 Using an existing procedure to Create a New Procedure...9-31 Deleting a Procedure ...9-31 HIS/RIS Broker Configuration ...9-32 Introduction...9-32 HIS/RIS Broker Configuration ...9-32 iv

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Push Configuration ... 9-34 CR Display Configuration ... 9-36 Reject Reason Configuration (Option)... 9-38 Setting Trauma Defaults (Option)... 9-40 Using Unique Numbers ... 9-41 Profile Destination Configuration ... 9-42 Default Profile Configuration ... 9-42 Configuring Profiles... 9-43 Text Box Configuration (Option) ... 9-45 External Text Boxes ... 9-45 Internal Text Box... 9-45 Combined Internal and External Text Boxes ... 9-46 External Text Box Characteristics... 9-47 Choosing a Text Box ... 9-47 Magnification Factor... 9-48 Using the Text Box Editor ... 9-48 Internal Text Box Editor ... 9-48 Text Box Viewer... 9-48 Text Box Editor... 9-48 Navigation Controls... 9-50 Adding a Column or a Row ... 9-50 Deleting or Saving a Field ... 9-50 External Text Box Editor... 9-50 Saving and Restoring Configuration Options ... 9-50 Configuring a Text Box ... 9-51 Delivery Preferences... 9-54 Delivery Option Configuration... 9-54 Configuring Default Hospital Name and Address ... 9-56 CAD Workstation Configuration ... 9-56 Configuring External Devices ... 9-57 Remote Operator Panel Expanded Connectivity... 9-57 Configuring a Remote Operator Panel to Multiple CR Systems... 9-59 Configuring Multiple ROPs to Multiple CR Systems... 9-62 Remote Patient Data Entry Software (RPDES) ... 9-65 Computer Requirements... 9-65 Installation Instructions... 9-65 RPDES Configuration Instructions... 9-65 RPDES Operation... 9-67 Create a RPDES Shortcut on the Desktop ... 9-67 Remote Key Operator... 9-68 June 3, 2003

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Table of Contents

Setting Up the Remote Key Operator...9-68 Logging In...9-68 Downloading Statistics ...9-69 Procedure Mapping ...9-69 Color Preferences ...9-70 Bar Code Configuration ...9-71 Overview ...9-71 Changing the Bar Code Characteristics ...9-71 Changing the Cassette ID Bar Code Format...9-73 Changing the Country Code ...9-74 Changing the Prefix and Suffix...9-75 Bar Code Examples for Scanning...9-78 Required Fields...9-85 System Maintenance Defaults ...9-87 Regional Settings...9-87 Configure Monitor...9-87 Miscellaneous ...9-89 Calibrate Touch Screen ...9-89 Administration ...9-91 User Maintenance ...9-91 Creating a New User ...9-91 Editing A User ...9-92 Deleting a User...9-92 User Login Configuration...9-93 Grid Detection and Suppression (Option) ...9-94 10 Remote Operations Panel Medical Device Directive (MDD) ...10-1 English ...10-2 Dansk ...10-2 Deutsch...10-3 Español ...10-3 Français ...10-4 Greek...10-4 Italiano ...10-5 Lietuviðkai ...10-5 Nederlands...10-6 Norsk...10-7 Português...10-7 Suomeksi ...10-8 Svenska ...10-8 vi

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Overview ...10-9 Start Up ...10-9 Operation...10-10 ROP Configured to Access Multiple CR Systems ...10-11 Bar Code Scanner ...10-12 Using the Bar Code Scanner ...10-12 Scanning a Bar Code ...10-12 Turning Off the ROP...10-13 Appendix A: Kodak DirectView Total Quality Tool for CR Systems Appendix B: Default Procedure Codes Appendix C: Printing Exceptions Text Box Rotation...C-3 Glossary Index

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1

Safety and Related Information CAUTION:

United States federal law restricts this device to sale to, by, or on order of a physician. IMPORTANT:

The side and back panels shall be opened by authorized Kodak service personnel only.

LASER WARNING:

This equipment uses a visible red laser. Laser radiation will be present when the machine is opened with the side and back panels removed and the interlocks defeated. Avoid direct exposure to the laser beam. This product is a Class 1 Laser product. This product complies with DHHS regulation 21 CFR Chapter I Subchapter J and IEC/EN 60825-1. CLASS 1 LASER PRODUCT. CLASS I EQUIPMENT. INTERNALLY POWERED EQUIPMENT. INTENDED FOR CONTINUOUS OPERATION. ACCEPTABLE FOR INCIDENTAL OR CASUAL CONTACT WITH THE PATIENT. PRODUCT IS PROVIDED WITH ORDINARY PROTECTION AGAINST THE HARMFUL INGRESS OF WATER. PRODUCT IS NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETICS MIXTURE WITH AIR OR WITH OXYGEN OR WITH NITROUS OXIDE.

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Safety and Related Information

EUROPEAN MARKETS only: This device is Class I, Type B medical equipment as defined by EN 60 601-1. AUTHORIZED REPRESENTATIVE: Manager, Product Safety, Kodak AG; Hedelfingerstr. 54-56, 70327 Stuttgart, GERMANY. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • Use of the accessory in the patient vicinity. • Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 950 and/or IEC 601-1 and/or IEC 601-1-1 harmonized national standard. CAUTION:

The small footprint and specifications of the CR 800/850 Systems allow for flexibility in placement of the unit, including in the exam room. When installed in this manner, scatter radiation from the x-ray system may cause image artifacts in two scenarios: • When CR cassettes are stored in the exam room. Precaution: CR cassettes should not be stored in the exam room or kept in the exam room during individual patient studies. • When an exposed CR cassette is being scanned by the CR 800/850 System in the exam room during a subsequent x-ray exposure. Precaution: The potential exists for artifacts if one cassette is being processed while a second cassette is being exposed. If you experience image artifacts, we suggest you discontinue simultaneous exposing and processing of CR cassettes.

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Safety and Related Information

CAUTION:

Kodak DirectView CR Cassettes contain lead. Disposal of components that contain lead may be regulated due to environmental conditions. For disposal or recycling information, contact your local authorities or visit the Electronics Industry Alliance web site at http://www.eiae.org. CAUTION:

The UPS battery must be replaced by a Kodak authorized Service Provider. The UPS battery contains lead and poses a hazard to the environment and human health if not disposed of properly. Due to the toxicity of lead, the US EPA’s Resource Conservation and Recovery Act (RCRA) and state solid/hazardous waste authorities consider a spent lead-acid battery a regulated waste. Treat this battery as a hazardous waste if it is not recycled. A recycling infrastructure is widely available in the US to manage this battery type. CAUTION:

This product contains mercury. Disposal of components containing this material may be regulated due to environmental considerations. For disposal or recycling information, please contact your local authorities or visit the Electronics Industry Alliance Web site at http://www.eiae.org. The information contained herein is based on the experience and knowledge relating to the subject matter gained by Eastman Kodak Company prior to publication. No patent license is granted by this information. Eastman Kodak Company reserves the right to change this information without notice and makes no warranty, express or implied, with respect to this information. Kodak shall not be liable for any loss or damage, including consequential or special damages, resulting from the use of this information, even if loss or damage is caused by Kodak's negligence or other fault.

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Safety and Related Information

KODAK DirectView CR800 system SERVICE 3519 SERIAL CODE NUMBER

MANUFACTURED: 100-127V~ 200-240V~

50/60Hz 50/60Hz SS I F I E LA

D

C

N137 C

US

25YA

10A 5A MEDICAL ELECTRICAL EQUIPMENT CLASSIFED BY UNDERWRITERS LABORA TORIES INC. WITH RESPECT TO ELECTRICAL SHOCK, FIRE, MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY, IN ACCORDANCE WITH UL 2601-1 AND CAN-CSA C22.2 No. 601.1.

THIS PRODUCT COMPLIES WITH 21 CFR CHAPTER I, SUBCHAPTER J. CERTIFIED ONLY TO CANADIAN ELECTRICAL CODE / CER TIFIE EN VER TU DU CODE CANADIAN DE L’ELECTRICITE SEULEMENT. Made in U.S.A. by EASTMAN KODAK COMPANY Rochester, NY 14650 5E3348

H177_0011HC

KODAK DirectView CR900 system SERVICE 3520 SERIAL CODE NUMBER

MANUFACTURED: 100-127V~ 200-240V~

50/60Hz 50/60Hz SS I F I E LA

D

C

N137 C

US 25YA

10A 5A MEDICAL ELECTRICAL EQUIPMENT CLASSIFED BY UNDERWRITERS LABORA TORIES INC. WITH RESPECT TO ELECTRICAL SHOCK, FIRE, MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY, IN ACCORDANCE WITH UL 2601-1 AND CAN-CSA C22.2 No. 601.1.

THIS PRODUCT COMPLIES WITH 21 CFR CHAPTER I, SUBCHAPTER J. CERTIFIED ONL Y TO CANADIAN ELECTRICAL CODE / CER TIFIE EN VER TU DU CODE CANADIAN DE L’ELECTRICITE SEULEMENT. Made in U.S.A. by EASTMAN KODAK COMPANY Rochester, NY 14650 3H9506

H187_0001HC

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Safety and Related Information

KODAK DirectView CR 850 system SERVICE SERIAL 4825 NUMBER CODE

MANUFACTURED: 50/60 Hz 50/60 Hz

N137SSI F I

E

C

100-127V~ 200-240V~

D

LA

R

10A 5A MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2 No. 601.1. 25YA

COMPLIES WITH 21 CFR 1040.10 AND 1040.11 EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO. 50, DATED JULY 26,2001. CERTIFIED ONLY TO CANADIAN ELECTRICAL CODE / CERTIFIE EN VERTU DU CODE CANADIAN DE L’ELECTRICITE SEULEMENT. Made in U.S.A. by EASTMAN KODAK COMPANY Rochester, NY 14650 1F4335

H194_0024HC

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Safety and Related Information

KODAK DirectView CR 950 system SERVICE SERIAL 4826 NUMBER CODE

MANUFACTURED: 50/60 Hz 50/60 Hz

N137SSI F I

E

C

100-127V~ 200-240V~

D

LA

R

10A 5A MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1, CAN/CSA C22.2 No. 601.1. 25YA

COMPLIES WITH 21 CFR 1040.10 AND 1040.11 EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO. 50, DATED JULY 26,2001. CERTIFIED ONLY TO CANADIAN ELECTRICAL CODE / CERTIFIE EN VERTU DU CODE CANADIAN DE L’ELECTRICITE SEULEMENT. Made in U.S.A. by EASTMAN KODAK COMPANY Rochester, NY 14650 1F5241

H196_0100HC

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Safety and Related Information

Health and Safety Compliance The CR 800/CR 900 Series Systems were examined for compliance and have classifications and licenses as follows:

CR 800/900 Systems

U. S. A. 47 CFR Part 15, Sub B, Class A UL 2601-1 Medical Electrical Equipment 2nd Edition Canada CAN/CSA C22.2 No. 601.1-M90 - Medical Electrical Equipment CAN/CSA 22.2 No. 601.1S1-94 Supplement No. 1-94 to Medical Electrical Equipment (R1999) CAN/CSA 22.2 No. 601.1B-90 - Amendment 2 to Medical Electrical Equipment ICES-003 Issue 3, Class A ITE Emissions International IEC 60601 - 1: 1988, +A1 (1991), + A2(1995) Medical Electrical Equipment IEC 825-1 - (1993) Safety of Laser Products EN 60601-1-2:1993 Medical Electrical Equipment Electromagnetic Compatibility EN 55011: 1998 ISM Emissions, Group 1 Class A EN 61000-4-2: 1995 Electrostatic Discharge immunity test EN 61000-4-3:1997 Radiated, Radio-Frequency, electromagnetic field immunity EN 61000-4-4: 1995 Electrical Fast Transient/burst immunity EN 61000-4-5: 1995 Surge immunity EN 61000-4-6: 1996 Immunity to conducted disturbances EN 61000-4-11: 1995 Voltage dips, sags, interrupts EN 61000-3-2: 1995: Limits for harmonic current emissions EN 61000-3-3: 1995 Flicker

WARNING:

This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures.

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Safety and Related Information

CR 850/950 Systems

U. S. A. 47 CFR Part 15, Sub B, Class A UL 2601-1 Medical Electrical Equipment 2nd Edition Canada CAN/CSA 22.2 No. 601.1-M90 - Medical Electrical Equipment (R2001) CAN/CSA 22.2 No. 601.1S1-94 - Supplement No. 1-94 to Medical Electrical Equipment (R1999) CAN/CSA 22.2 No. 601.1B-90 - Amendment 2 to Medical Electrical Equipment (R2002) ICES-003 Issue 3, Class A ITE Emissions International IEC 60601 - 1: 1988, +A1 (1991), + A2(1995)Medical Electrical Equipment IEC 60825 - 1:1993 + A1:1997 + A2:2001 Safety of Laser Products EN 60601-1-2:1993 Medical Electrical Equipment Electromagnetic Compatibility EN 55011: 1998 ISM Emissions, Group 1 Class A EN 61000-4-2: 1995 Electrostatic Discharge immunity test EN 61000-4-3: 1997 Radiated, Radio-Frequency, electromagnetic field immunity EN 61000-4-4: 1995 Electrical Fast Transient/burst immunity EN 61000-4-5: 1995 Surge immunity EN 61000-4-6: 1996 Immunity to conducted disturbances EN 61000-4-11: 1995 Voltage dips, sags, interrupts EN 61000-3-2: 1995: Limits for harmonic current emissions EN 61000-3-3: 1995 Flicker WARNING:

This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures. Acoustic Noise Emission Information Operator position Sound Pressure Levels (LA) Standby

<70 dB(A)

Operate

<70 dB(A)

Tested per DIN 45635, ANSI S12.10-1985, ISO 7779.

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Safety and Related Information

Remote Operations Panel

U.S.A. UL 1950 Safety for Information Technology Equipment Canada CAN/CSA C22.2 No. 950-95 Safety for Information Technology Equipment International EN 60950:1992 Safety for Information Technology Equipment (with Amendments A1, A2, A3, A4, and A11) EN 55011:1998 ISM Emissions, Group 1 Class A EN 60601-1-2: 1993 Medical Electrical Equipment Electromagnetic Compatibility EN 61000 -3-2:1995 Powerline Harmonics EN 61000 -3-3:1995 Flicker EN 61000 -4-2:1995 ESD EN 61000 -4-3: 1997 RF immunity EN 61000 -4-4: 1995 EFT EN 61000 -4-5: 1995 Surge immunity EN 61000 -4-6: 1996 Conducted immunity EN 61000 -4-11: 1995 Voltage dips, sags, interrupts WARNING:

This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures.

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Safety and Related Information

User Guide Conventions Special Messages

The following special messages emphasize information or indicate potential risks to personnel or equipment. NOTE: Notes provide additional information, such as expanded explanations, hints, or reminders. IMPORTANT:

Important notes highlight critical policy information that affects how you use this guide and this product.

CAUTION:

Cautions point out procedures that you must follow precisely to avoid damage to the system or any of its components, loss of data, or corruption of files in software applications. WARNING:

Warnings identify procedures that you must follow precisely to avoid injury to yourself or others. LASER WARNING:

Laser warnings warn personnel that access to laser radiation is possible and all personnel must avoid direct exposure to the beam. Typeface Conventions Boldface type represents buttons or selections that you make on the touch screen and to identify screen names.

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Overview

Product Description The Kodak DirectView CR 800/CR 900 Series systems process and produce digital images directly from latent images captured on storage phosphor screens. You can reproduce, reprocess, and distribute images to other output and storage devices. The CR Systems manage patient and examination information associated with the captured and stored images. They can interface with a PACS Broker such as Mitra to obtain patient demographic data from the site HIS/RIS system. The data is sent to the CR System where it is associated with the proper image. You can use the CR System to: • Read images on a phosphor screen using conventional X-ray generators. • Modify images and change image orientation. • Enter examination and patient information using the Kodak DirectView Remote Operations Panel (ROP), the bar code scanner, or the touch screen monitor. • Correct erroneous patient or examination information. • Store images that have incomplete patient or study data until the required data is added and the image is accepted. • Create collections of related images and data (a Study). • Send exams to DICOM storage devices, physician’s diagnostic viewing stations, and DICOM laser imagers. The CR 900/950 System is designed for use as a centralized processing unit serving multiple exposure rooms in conjunction with the Kodak DirectView Remote Operations Panel (ROP). See page 10-10 for information on using the ROP.

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