Kodak DryView 8900 Laser Imager Release 3 User Guide Rev F Jan 2006

Eastman Kodak Company 343 State Street Rochester, NY 14650 © Eastman Kodak Company, 2006 Kodak and DryView are trademarks of Eastman Kodak Company.

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Table of Contents

1 Safety and Related Information Safety, Warnings, and Cautions ... 1-1 Safety Labels ... 1-6 Safety and Health Compliance... 1-11 Safety ... 1-11 EMC... 1-12 EU Directives ... 1-17 CE Marking... 1-18 User Guide Conventions ... 1-18 Please Note ... 1-19 2 Overview Product Description ... 2-1 System Components ... 2-2 How the Laser Imager Works... 2-3 3 Operation and Maintenance System Power Up, Shut Down, and Energy Save ... 3-1 Power Up... 3-1 Restart / Shut Down ... 3-2 Energy Save... 3-2 Levels of User Access ... 3-3 Power Failures... 3-3 Using the Touch Screen Local Panel ... 3-4 Status Screen ... 3-4 Main Menu ... 3-6 Door Control Screen... 3-7 System Functions Screen... 3-8 System Information Screen ... 3-9 Version Information ... 3-10 Job Management Screen ... 3-11 View List... 3-12 Image Sources Screen ... 3-13 Operation... 3-14 Opening the Left Front Door ... 3-14 Opening the Right Front Door... 3-14 Opening the Film Drawers ... 3-14 January 10, 2006

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Film Drawers and Front Door Manual Override Latches...3-14 Opening the Hood...3-16 Loading Film Cartridges ...3-18 Recycling Empty Film Cartridges...3-19 Requesting a Calibration Test Print...3-19 Requesting a Density Test Print ...3-19 Requesting a QC Step Wedge ...3-20 Printing a DVM (DryView Mammography) Test Pattern...3-20 Evaluating DVM Test Patterns ...3-21 Automatic Image Quality Control (AIQC)...3-21 Operating in Manual Mode ...3-21 Operator Maintenance...3-23 Cleaning the Laser Imager...3-23 Installing a New Charcoal Filter...3-23 Preventive Maintenance...3-25 Key Operator Information...3-26 Key Operator Passcode...3-26 Setting Time and Date ...3-27 Audible Alarm (On/Off) ...3-29 Selecting Bins...3-30 Changing Dmax...3-32 Deleting Print Jobs ...3-34 Scheduling the Automatic Energy Save Mode...3-36 Image Resizing Icons ...3-39 4 Troubleshooting Status and Error Messages...4-1 Local Panel Status Messages...4-1 Local Panel Error Messages ...4-3 Operator Actions ...4-4 Clearing Film Jams...4-25 Manually Closing the Film Cartridge Lid ...4-26 Film Pickup Problems in Area 1U, 1M, or 1L ...4-26 Clearing Film Jams from Area 2...4-27 Clearing Film Jams from Area 3...4-28 Clearing Film Jams from Area 4...4-29 iv

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Clearing Film Jams from Area 5 ... 4-31 Clearing Film Jams from Area 6 ... 4-32 Calling for Support... 4-33 5 Specifications Dimensions ... 5-1 Electrical... 5-1 Laser Specifications... 5-2 Operating Environment ... 5-2 Storage Environment ... 5-2 Environmental Effects... 5-2 Film Sizes ... 5-3 Film Types... 5-3 Film Throughput ... 5-3 Agency Compliance ... 5-3 6 Film Technical Information General Description ... 6-1 Spectral Sensitivity ... 6-1 Image Quality... 6-2 Automatic Image Quality Control ... 6-2 Environmental Impact... 6-3 Storing and Handling Undeveloped Film ... 6-3 Handling Developed Film... 6-3 Archiving Developed Film ... 6-4 Exposing to Moisture ... 6-4 Dissipating Odor... 6-4 Dissipating Heat... 6-5 Recycling Film ... 6-5 Appendix A: Quality Control Procedures Compliance Guide - Quality Control for Laser Imagers Used in Digital Mammography Systems... A-1 Automatic Image Quality Control and the QC Process ... A-1 Running a QC Baseline Test ... A-2 Procedure for the Installing Field Engineer... A-2 Procedure for the QC Technologist ... A-2 Baseline Test... A-2

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Running a Daily QC Test...A-5 Appendix B: Warranty and Limitation of Liability Important Notice to Purchaser...B-1 End User License Agreement (EULA) ...B-2 Eastman Kodak Company Health Group Software End User License Agreement ...B-2 License ...B-2 Limited Warranty ...B-3 Limitation of Remedies ...B-4 General...B-4 U.S. Government Restricted Rights...B-4 End-User License Agreement for Microsoft Desktop Operating Systems...B-5 Software Product License...B-5 Warranty and Special Provisions for Austria, New Zealand or Papua New Guinea - Express Limited Warranty...B-12 Warranty and Special Provisions for England Scotland, Wales and Ireland - Limited Warranty...B-13 Warranty and Special Provisions for Canada - Limited Warranty ...B-15 GARANTIE ET DISPOSITIONS PARTICULIÈRES POUR LE CANADA GARANTIE LIMITÉE ...B-16 Warranty and Special Provisions for the United States of America and any Other Country - Limited Warranty...B-17 Glossary

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Safety and Related Information

Safety, Warnings, and Cautions Please read and understand all instructions before using this product. RISK OF ELECTRIC SHOCK: This equipment is operated with hazardous voltage which can shock, burn, or cause death. • Remove wall plug before servicing equipment. Never pull on cord to remove from outlet. Grasp plug and pull to disconnect. Only perform maintenance that is described in this User Guide. To avoid exposure to dangerous voltage, laser beam, or other danger, do not attempt to service or repair the laser imager yourself. Always call an Authorized Service Provider of Kodak products for any service or repair. • Do not operate equipment with a damaged power cord. • Do not use an extension cord to power this equipment. • Do not operate equipment with any of the safety interlocks overridden. • Position the power cord so it will not be tripped over or pulled. • Connect this equipment to a grounded wall outlet. WARNING: This equipment contains moving parts that may be accessible to the user. Loose clothing, jewelry or long hair may cause personal injury or damage to the equipment. • Do not operate equipment with the covers open. • Do not operate equipment with any of the safety interlocks overridden.

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Safety and Related Information

WARNING: This equipment is not contained in a sealed cabinet. Do not use this equipment in locations where it can come in contact with liquids, including body fluids. CAUTION: Do not use a cell phone within 2 meters of a laser imager. This proximity includes any imager behind a wall adjacent to your location. CAUTION: Do not use a microwave oven within 4 meters of a laser imager. Electromagnetic radiation from a microwave oven is only an issue if after the oven door is closed and latched, the seal does not maintain an electromagnetic tight fit between the oven door and oven main housing. Determining if the seal has an electromagnetic tight fit requires special detection equipment. CAUTION: Do not use in the presence of flammable anesthetics, oxygen, or nitrous oxide. This equipment does not have a gas-sealed electronics enclosure and could ignite any flammable or explosive gases present in its environment.

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Safety and Related Information

CAUTION: This equipment is intended to connect to other medical devices. Only an Authorized Service Provider of Kodak products may perform installation and service maintenance. This device is NOT to be located within the patient environment. Therefore, the equipment must not be located closer than 1.83 meters from a patient bed or chair.

1.83 m

CAUTION: This device should not be used in close contact with MRI devices, due to possible very high magnetic fields near an MRI unit. For magnetic field specifications, see "Operating Environment" on page 5-3. CAUTION: Do not substitute or modify any part of this equipment without prior written approval of Eastman Kodak Company. CAUTION: Federal law prohibits dispensing without a prescription. CAUTION: 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 January 10, 2006

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Safety and Related Information

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 User Guide, 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. CAUTION: Do not use isopropyl alcohol to clean the exterior surfaces of the laser imager. Isopropyl alcohol can dissolve the exterior paint on the laser imager. CAUTION: Filters are considered to be non-hazardous waste according to the US Environmental Protection Agency Resource Conservation Recovery Act (RCRA). You may dispose of filters in a landfill or incinerator with energy recovery in a municipal, commercial or industrial facility. Contact your state or local government to determine if additional disposal requirements apply. CAUTION: Lithium batteries should only be replaced by an Authorized Service Provider of Kodak products. The laser imager uses a lithium battery to power the clock and calendar circuitry. THERE IS A DANGER OF EXPLOSION IF THE BATTERY IS REPLACED INCORRECTLY. The battery must be replaced only with the same or equivalent type recommended by Motorola Inc. The US EPA’s RCRA does not regulate disposal of this lithium battery. Users should discard spent batteries in municipal trash unless their community offers a battery collection program.

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Safety and Related Information

CAUTION: This product contains lead and mercury. The lead is located in the solder on the circuit boards. Mercury is located in the back light of the local panel. Disposal of components containing these materials may be regulated due to environmental considerations. For disposal or recycling information at the end of usable service, please contact your local authorities or visit the Electronics Industry Alliance Web site at: http://www.eiae.org.

LASER WARNING: The equipment uses a 100-milliwatt invisible laser. Laser radiation may be present when the machine operates without the rear cover installed. Covers with this label may only be removed by an Authorized Service Provider of Kodak products. USE OF CONTROLS OR ADJUSTMENTS, OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN, MAY RESULT IN EYE DAMAGE.

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Safety and Related Information

Safety Labels

Safety labels are attached to the laser imager in compliance with international standards.

Laser Radiation Warning Labels

Laser Interlock. This warning label indicates that laser energy is present. Defeating interlocks allows the laser imager to run with the laser energized. AVOID DIRECT EXPOSURE TO THE LASER BEAM. EXPOSURE TO LASER ENERGY MAY RESULT IN PERMANENT EYE DAMAGE.

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Safety and Related Information

High Voltage Warning Label

This warning label indicates that high voltage is present under panels or enclosures where labels are attached. These panels may only be removed by an Authorized Service Provider of Kodak products.

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Safety and Related Information

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Warning and Caution Labels

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1-8

Invisible Laser Radiation Present When Open. This warning label indicates that invisible laser radiation is present under panels where labels are attached. These panels may only be removed by an Authorized Service Provider of Kodak products. AVOID DIRECT EXPOSURE TO THE LASER BEAM. EXPOSURE TO LASER ENERGY MAY RESULT IN PERMANENT EYE DAMAGE. DEFEATING INTERLOCKS ALLOWS THE LASER IMAGER TO RUN WITH THE LASER ENERGIZED.

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Hazardous Voltage. This warning label indicates that high voltage is present under panels where the label is attached. Only an Authorized Service Provider of Kodak products should attempt access.

3

Static Sensitive Equipment. This label identifies static-sensitive components. Connect a personal grounding strap to an appropriate ground before servicing this laser imager. These panels may only be removed by an Authorized Service Provider of Kodak products.

4

Class 1 Laser. This label indicates that the laser imager complies with IEC requirements for Class 1 systems.

5

Radio Frequency Energy. This label indicates that the laser imager can radiate radio frequency energy. If not installed and used in accordance with the instructions, the laser imager may cause harmful interference to radio communications.

6

Japanese Import License.

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Safety and Related Information

1

2 3

CAUTION: Do not touch, Hot surface!

ATTENTION : Surface Chaude, Ne pas toucher!

NEW LANGUAGE: Do not touch, Hot surface!

ADVERTENCIA: No tocar, Superficia Caliente!

ACHTUNG: Nicht anfassen, Heisse Oberflache!

NEW LANGUAGE: Do not touch, Hot surface!

OPGEPAST: Niet aanraken, Heet Oppervlak!

ATTENZIONE: Non toccare,Superficie Calda!

NEW LANGUAGE: Do not touch, Hot surface!

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4

Processor Drum Cover Label

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1

Processor drum cover pictogram. This pictogram illustrates the processor drum cover open. When open, take caution to avoid heat and use of sharp objects.

2

Caution - hot surface pictogram. This pictogram advises to use care near the processor drum to avoid possible burns.

3

Caution - no sharp objects pictogram. This pictogram advises to avoid using sharp objects near the processor drum.

4

ISO label. This warning label advises to use care near the processor drum to avoid possible burns.

5

ISO label. This label identifies a possible warning or caution and indicates applicable information in the User Guide.

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Safety and Related Information

Safety and Health Compliance This equipment has been tested for and complies with the following Safety and Emissions Standards. Certificates of Compliance and Declarations of Conformity have been issued as shown below.

Safety

United States 21 CFR 900.12(e) Mammography Quality Standards Act; Quality Standards; Quality Assurance for Equipment. 21 CFR 1040.10 Class I Code of Federal Regulations Title 21 Food and Drugs Chapter I Food and Drug Administration, Department of Health and Human Services Volume 8 - Parts 800 to 1299 Subchapter J - Radiology Health Part 1040 - Performance Standards for Light Emitting Products Section 10 - Laser Products FDA 21CFR 807 Premarket Notification 510(K): Regulatory Requirements For Medical Devices. UL 60950-1: Safety of Information Technology Equipment, including Electrical Business Equipment (Bi-National Standard). IEC 60601-1-1: Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19. IEC 60825-1: Safety of laser products - Part 1 : Equipment classification, requirements and user’s guide. Canada CAN/CSA - C22.2 NO 60950-1-03 Information Technology Equipment Safety - Part 1: General Requirements. (Bi-National Standard, with UL 60950-1). IEC 60601-1-1: Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19.

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Safety and Related Information

IEC 60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user’s guide. Europe EN60950-1: Safety of Information Technology Equipment, including Electrical Business Equipment (IEC 60950: 1991, Modified) (Includes Amendment A1, A2, A3, A4, and A11). EN60601-1-1: Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19. EN60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user's guide. Rest of World IEC 60950-1: Safety of information technology equipment. IEC 60601-1-1: Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems. IEC 60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user's guide.

EMC

United States FCC Rules and Regulations, Title 47, Part 15, Subpart B, Class A: Radio Frequency Devices: Unintentional Radiators. This equipment has been tested and been found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC rules. Those limits are designed to provide reasonable protection against harmful interference in a residential installation. FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices: Intentional Radiators. “FCC ID: PA 48E1587”

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Safety and Related Information

Canada CAN/CSA-C108.6-M91, Class A: Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment. Intentional Radiation “IC: 1016B8E1587” This Class A digital apparatus complies with Canadian ICES-003. CET APPAREIL NUM ENRIQUE DE CLASSE A EST CONFORME A LA NORME NMB-003 DU CANADA. This Class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. Europe and the Rest of World Guidance and Manufacturer’s Declaration for Electromagnetic Emissions

The Kodak DryView 8900 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the Kodak DryView 8900 Laser Imager should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions:

Group 1

The Kodak DryView 8900 Laser Imager uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

The Kodak DryView 8900 Laser Imager is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Class A

The Kodak DryView 8900 Laser Imager is suitable for use everywhere, including those establishments directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

The Kodak DryView 8900 Laser Imager is suitable for use everywhere, including those establishments directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

• EN55011 • CISPR 11 RF emissions: • EN55011 • CISPR 11 Harmonics emissions: • EN61000-3-2 • IEC 61000-3-2 Voltage fluctuations and flicker emissions: • EN61000-3-3 • IEC 61000-3-3

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Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

The Kodak DryView 8900 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the laser imager should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level Compliance Level

Electromagnetic Environment Guidance

Electrostatic discharge (ESD):

± 6 kV contact ± 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

± 6 kV contact ± 8 kV air

• EN61000-4-2 • IEC 61000-4-2 Electrical fast transient/burst:

± 2 kV for power supply ± 2 kV for power supply lines

lines

Mains power quality should be that of a typical commercial or hospital environment.

• EN61000-4-4 • IEC 61000-4-4

± 1 kV for input/output ± 1 kV for input/output

Surge:

± 1 kV differential mode ± 1 kV differential mode ± 2 kV common mode ± 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% Uτ * (>95% dip in <5% Uτ * (>95% dip in Uτ *) for 0.5 cycle Uτ *) for 0.5 cycle

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Kodak DryView 8900 Laser Imager requires continued operation during power mains interruptions, it is recommended that the Kodak DryView 8900 Laser Imager be powered from an uninterruptible power supply or a battery.

• EN61000-4-5 • IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply lines: • EN61000-4-11 • IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field:

lines

lines

40% Uτ * (60% dip in Uτ *) for 5 cycles

40% Uτ * (60% dip in Uτ *) for 5 cycles

70% Uτ * (30% dip in Uτ *) for 25 cycles

70% Uτ * (30% dip in Uτ *) for 25 cycles

<5% Uτ * (>95% dip in <5% Uτ * (>95% dip in Uτ *) for 5 sec. Uτ *) for 5 sec. 3 A/m

3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

• EN61000-4-8 • IEC 61000-4-8 NOTE: * Uτ is the a.c. mains voltage prior to application of the test level.

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