Kodak Kodak DryView 8600 User manual

7 X 9 inside cover

User Guide

Kodak DryView 8600 Laser Imaging System /

for Mammography

8186546

74-0401-6533-9

3/00 Rev. B

Classification, Warnings, and Cautions

i

2000 March Rev. B 8186546

Classification, Warnings, and Cautions

for DryView 8600 Laser Imager

Read and understand all instructions before using.

Classifications

UL Classified

File Number E163816

Control Number 48VF

Medical Equipment

UL 2601-1 CAN/CSA No. 601.1

!

Classified by Underwriters Laboratories Inc. With Respect to Electric Shock,

Fire, Casualty and Medical Hazards only in Accordance with UL 2601-1, CAN/CSA

C22.2 No. 601.1 and IEC 601.1.

!

WARNING

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.

Do not operate equipment with a damaged power cord.

Do not use an extension cord to power this equipment.

Use only the power cord supplied with the equipment.

Position the power cord so it will not be tripped over or pulled.

Connect this equipment to a grounded outlet.

!

WARNING

Not protected against ingress of liquids, including bodily fluids.

!

WARNING

For continued protection against fire, replace fuses only with fuses of the same type

and rating.

DryView 8600 User Guide

ii

8186546 2000 March Rev. B

Classification, Warnings, and Cautions

for DryView 8600 Laser Imager (continued)

Avoid touching the developer drum when removing film jams from the imager. The

developer drum may become hot during extended imager operation.

!

CAUTION

This equipment has been tested and found to comply with the limits for a Class B

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. This equipment generates, uses, and can radiate radio frequency

energy and, if not installed and used in accordance with the instructions, may cause

harmful interference to radio communications. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment does cause

harmful interference to radio or television reception, which can be determined by

turning the equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

 Reorient or relocate the receiving antenna.

 Increase the separation between the equipment and the receiver.

 Connect the equipment into an outlet on a circuit different from that to which the

receiver is connected.

 Consult the dealer or an experienced radio/TV technician for help.

!

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.

Classification, Warnings, and Cautions

iii

2000 March Rev. B 8186546

Classification, Warnings, and Cautions

for DryView 8600 Laser Imager (continued)

!

CAUTION

U.S. Federal law restricts sale of this device to or on the order of a licensed health

care practitioner.

!

CAUTION

This equipment is intended to connect to other medical devices. Installation and

service maintenance are to be performed only by qualified service personnel. The

Kodak PACS Link 9410 Acquisition System must be installed no closer than 1.8

meters from a patient bed or chair.

!

CAUTION

Avoid Laser Beam

This equipment employs an invisible 25 milliwatt laser beam. Laser

radiation may be present when the machine operates without panels or

covers installed.

Use of controls or adjustments, or performance of procedures other than those

specified herein, may result in eye damage.

Covers shall be removed by authorized service personnel only.

There are no “user” serviceable parts in this machine.

!

CAUTION

General External Cleaning: This equipment may be cleaned with a damp cloth

using water with mild detergent, or commercial electronic equipment cleaner.

!

CAUTION

Do not substitute or modify any part of this equipment without approval of Eastman

Kodak Company.

DryView 8600 User Guide

iv

8186546 2000 March Rev. B

Classification, Warnings, and Cautions

for DryView 8600 Laser Imager (continued)

Type B Applied Part

Safety, EMC, and CE Marking Compliance

v

1999 June Rev. A 8186546

Safety, EMC, and CE Marking Compliance

Agency Approvals

This equipment has been tested for and complies with the following Safety and

Emission Standards. Certificates of Compliance and Declarations of Conformity

have been issued for the following areas:

Australia/New Zealand:

AS/NZS 3548:1992

AS 2211-1991

AS3200.1-1990/NZS 6150:1990

Canada:

C108.8-M1983 Class B (Conducted and Emitted EMI/RFI Specs)

CAN/CSA-C22.2 No. 601.1

Europe:

EN50082-1 (EMC)

EN55011 Group 1 Class B (Medical Device Safety)

EN60601-1 (Safety Medical Equipment)

EN60825:1991 (Laser Safety)

EN61000-3-2: Harmonics

IEC61000-3-3:1995 Voltage Fluctuations/Flicker

IEC61000-4-2:1995 ESD

IEC61000-4-3:1996 Radiated Radio Frequency

IEC61000-4-4:1995 Fast Transient/Burst

IEC61000-4-5:1995 Surge

IEC61000-4-6: Conducted Radio Frequency

IEC61000-4-8: Power Frequency Magnetic Fields

IEC61000-4-11: Dips and Interrupts

DryView 8600 User Guide

vi

8186546 1999 June Rev. A

Japan:

CISPR Group 1 Class B

USA:

47CFR15B Class B (Conducted and Emitted EMI/RFI Specs)

FDA: 21CFR CH-1. SCH-J. Part 1040 (Performance Standards for Light

Emitting Products)

UL 2601-1 (Medical and Dental Equipment)

IEC 601-1 (Medical Device Safety)

IEC 601-1-1 (EMC for Medical Devices)

IEC 825-1 (Laser Safety)

ROW:

CISPR 11 Group 1 Class B (Conducted and Emitted EMI/RFI Specs)

IEC 1000-4-2, 3, 4, 5, 6, 8, and 11

CE Marking:

This equipment is part of a medical system and conforms to the medical safety and

EMC in EN60601-1-1, EN60601-1-2, and the 93/42/EEC, MDD (Medical Device

Directive).

A Technical File and Declaration of Conformity with the Essential Requirements of

the Medical Device Directive have been prepared and signed by the appropriate

personnel and are located at:

Kodak AG

Quality Services and Product Safety

70323 Stuttgart Germany

Telephone 49-0711-40-06-5291

Safety, EMC, and CE Marking Compliance

vii

1999 June Rev. A 8186546

FCC:

This device complies with the limits for a Class B digital device listed in Part 15 of

the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that

may cause undesired operation.

Industry Canada:

This Class B digital apparatus meets all requirements of the Canadian

Interference-Causing Equipment Regulations.

Cet appareil numérique de la Classe B respecte toutes les exigences du Règlement

sur le matérial brouilleur du Canada.

EU:

This equipment complies with the January 1996 EU Community EMC Requirements,

per EN55011 Class B.

DryView 8600 User Guide

viii

8186546 1999 June Rev. A

BLANK PAGE

Table of Contents

ix

1999 June Rev. A 8186546

PLEASE NOTE

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.

Table of Contents

Description Page

Classification, Warnings, and Cautions i. . . . . . . . . . . . . . .

Safety, EMC, and CE Marking Compliance v. . . . . . . . . . . .

Section 1 – Introduction 1-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Kodak DryView 8600 Laser Imaging System / for

Mammography 1-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

How the DryView 8600 Laser Imager Works 1-2. . . . . . . . .

Automatic Image Quality Control 1-3. . . . . . . . . . . . . . . . . . .

Systems Connecting to the DryView 8600 Laser Imager 1-3

Service and Installation 1-3. . . . . . . . . . . . . . . . . . . . . . . . . . . .

IMPORTANT NOTICE TO PURCHASER 1-4. . . . . . . . . . . .

Section 2 – Controls and Indicators 2-1. . . . . . . . . . . . . . . . . .

DryView 8600 Laser Imager Controls – Main 2-1. . . . . . . .

Local Panel Controls and Indicators 2-2. . . . . . . . . . . . . . . . .

(Optional) Remote Keypad Controls and Indicators 2-3. . .

System Setup 2-4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General Setup Menus 2-5. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Menu Buttons 2-6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Menu Format 2-7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Menu Change Procedure 2-8. . . . . . . . . . . . . . . . . . . . . . . . . .

Parameter Menu Table 2-9. . . . . . . . . . . . . . . . . . . . . . . . . . . .

DryView 8600 User Guide

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8186546 1999 June Rev. A

Description Page

Section 3 – Operation 3-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

System Power Up 3-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Producing a Print from a Host Modality 3-2. . . . . . . . . . . . . .

Producing a Print Using the Keypad 3-2. . . . . . . . . . . . . . . .

Requesting Contrast Samples and Changing

the Contrast Setting 3-6. . . . . . . . . . . . . . . . . . . . . . . .

Digital Modality with Host Control 3-6. . . . . . . . . . . . . . . .

Digital Modality with Remote Keypad 3-7. . . . . . . . . . . .

Loading/Unloading the Film Tray 3-8. . . . . . . . . . . . . . . . . . .

Section 4 – Quality Control Procedures 4-1. . . . . . . . . . . . . .

Running a QC Baseline Test 4-1. . . . . . . . . . . . . . . . . . . . . . .

Running a Daily QC Test 4-4. . . . . . . . . . . . . . . . . . . . . . . . . .

Section 5 – Troubleshooting 5-1. . . . . . . . . . . . . . . . . . . . . . . . .

Local Panel and Remote Keypad Message Types 5-1. . . .

Local Panel Messages 5-1. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clearing Film Jams – General 5-7. . . . . . . . . . . . . . . . . . . . . .

Inserting the Film Saver and Removing the Film Tray 5-8.

Clearing Jams from the Film Tray Area 5-9. . . . . . . . . . . . . .

Clearing Jams from the Exposure Area 5-10. . . . . . . . . . . . . .

Clearing Jams from the Developer and Exit Areas 5-11. . . .

Safety Precautions 5-11. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clearing the Developer or Exit Jam 5-12. . . . . . . . . . . . . .

System Tests 5-13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Test Menus 5-13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Menu Buttons 5-14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Print QC Step Wedge 5-15. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Print SMPTE Pattern 5-15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Keypad Test 5-16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Display Software Versions 5-17. . . . . . . . . . . . . . . . . . . . . . . . .

Display System Configuration 5-18. . . . . . . . . . . . . . . . . . . . . .

Configuration Menu Table 5-19. . . . . . . . . . . . . . . . . . . . . . . . .

Calling for Support 5-20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table of Contents

xi

1999 June Rev. A 8186546

Description Page

Section 6 – Specifications 6-1. . . . . . . . . . . . . . . . . . . . . . . . . . .

Dimensions 6-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electrical 6-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operating Environment 6-1. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Non-Operating Environment: Shipping and Storage 6-1. . .

Interface Modules 6-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Control Interfaces 6-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Output 6-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Film Characteristics 6-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Options 6-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Agency Compliance 6-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Restrictions 6-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 7 – Technical Information 7-1. . . . . . . . . . . . . . . . . . . .

Spectral Sensitivity 7-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Image Quality 7-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Image Sharpness 7-1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Automatic Image Quality Control 7-2. . . . . . . . . . . . . . . . . . .

Less Impact on the Environment 7-3. . . . . . . . . . . . . . . . . . .

Storage and Handling of Undeveloped Film 7-4. . . . . . . . . .

Handling of Developed Film 7-4. . . . . . . . . . . . . . . . . . . . . . . .

Archivability of Developed Film 7-5. . . . . . . . . . . . . . . . . . . . .

Exposure to Moisture 7-5. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Odor Dissipation 7-5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Heat Dissipation 7-5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Film Recycling 7-6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operator Training Guidelines 1. . . . . . . . . . . . . . . . . . . . . . . .

DryView 8600 User Guide

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8186546 1999 June Rev. A

BLANK PAGE

Section 1 – Introduction

1-1

1999 June Rev. A 8186546

Introduction

The Kodak DryView 8600 Laser Imaging System / for Mammography

The Kodak DryView 8600 Laser Imager / for Mammography is a continuous tone

laser imager with an integrated photothermographic film developer. The imager

produces high-quality monochrome images, using an optical laser scanning system,

a data control system that manages external data flow, and a film developer.

The imager uses 8 by 10-inch (20.3 by 25.4 cm) Kodak DryView Mammography

Laser Imaging Film. Each film package contains 100 sheets of film.

The imager produces the first print in approximately 185 seconds, and subsequent

prints at approximately 25 prints per hour. It can produce output from more than one

modality.

The imager acquires, formats and prints images under control of a host modality.

The operator uses a local panel on the imager for control of various local functions.

No machine maintenance is required of the operator.

Figure 1-1. Kodak DryView 8600 Laser Imager / for Mammography

DryView 8600 User Guide

1-2

8186546 1999 June Rev. A

How the DryView 8600 Laser Imager Works

Each time it receives a print command, the imager prints an image using the

following sequence.

Note

The circled numbers in Figure 1-2 match the sequence steps. Dashed lines

show the film path.

1. Feed film – The feed area drives a sheet of film from the supply tray and feeds it

into the separation rollers.

2. Separate film – The separation rollers check for more than one sheet, then drive

a single sheet of film into the exposure module.

3. Expose film – A laser beam exposes the film. The film is then guided into the

film developer.

4. Develop film – The film develops as it passes over the heated developer drum.

5. Check image quality – The film is routed from the film developer, through the

densitometer, and out to the receive tray.

Figure 1-2. Print Sequence

Section 1 – Introduction

1-3

1999 June Rev. A 8186546

Automatic Image Quality Control

The built-in densitometer is a key element in the Automatic Image Quality Control

(AIQC) process. It enables the imager to automatically adjust image processing

parameters to produce the best image. The imager adjusts these parameters each

time it prints a calibration film. A calibration film is printed when:

 The DryView 8600 Laser Imager is powered on.

 The film tray is inserted in the imager.

 A calibration film is requested from the setup menu.

 The imager has not been used for 8 hours, and any type of print is

requested.

 The imager reactivates from Energy Saver mode.

Note

If the Energy Saver mode is activated, the DryView 8600 Laser Imager shuts

down its heaters and motors after 3 hours of inactivity. Any button pressed

reactivates the imager to automatically warm up to operating temperature.

Also, the imager reactivates if it is sent an image. A calibration film prints once

the imager reaches operating temperature.

Systems Connecting to the DryView 8600 Laser Imager

The DryView 8600 Laser Imager is used in full-field digital mammography (and in

other digital mammography applications) to reproduce digitized radiograph images

received from a digital radiography modality.

!

Warning

J1 (input/output) is intended for interconnection to equipment that complies

with the appropriate IEC 601-1/IEC 601-1-1 harmonized national standards

when interconnected.

Service and Installation

U.S. Connection: 120 volts Line to Neutral

Only factory-trained personnel are authorized to install and service the DryView

8600 Laser Imager. Circuit drawings are made available to the service technician.

DryView 8600 User Guide

1-4

8186546 1999 June Rev. A

IMPORTANT NOTICE TO PURCHASER

Kodak warrants that the Kodak DryView 8600 Laser Imager will be free from defects

in parts, material and manufacture for the period of one (1) year from the date of

installation. For defects occurring during the warranty period and about which Kodak

has received notice during the warranty period, Kodak will provide Buyer with free

replacement parts and labor to replace warranty-covered items.

THIS WARRANTY IS MADE IN LIEU OF ALL OTHER PRODUCT WARRANTIES

EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY

AND FITNESS, AND THOSE ARISING FROM A COURSE OF DEALING OR

USAGE OF TRADE.

The express warranty does not apply to the following: expendable parts; defects or

damage incurred in transportation to the end-user; defects or damage due to

neglect, misuse, operator error, improper installation or alteration of the DryView

8600 Laser Imager; or operation of the DryView 8600 Laser Imager out of

specification.

EXCEPT FOR THE EXCLUSIVE REMEDY STATED ABOVE, KODAK IS NOT

LIABLE FOR DIRECT DAMAGES. KODAK WILL NOT IN ANY EVENT BE LIABLE

FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, REGARDLESS

OF THE LEGAL THEORY ASSERTED, INCLUDING NEGLIGENCE AND STRICT

LIABILITY.

Section 2 – Controls and Indicators

2-1

1999 June Rev. A 8186546

Controls and Indicators

DryView 8600 Laser Imager Controls – Main

The imager uses the following controls. The numbered descriptions below

correspond to the numbered callouts in Figure 2-1.

1. Local Panel – Uses a two-line display with 40 characters per line to provide

status, setup, and test information. The panel contains six function buttons and a

numeric keypad. (See page 2-2 for details.)

2. Power Switch – Controls power to the imager.

3. Film Saver – Protects film from exposure when the film tray is temporarily

removed from the DryView 8600.

4. Remote Keypad –Displays control settings for the imager and allows you to

adjust these settings. (See page 2-3 for details.) This keypad is an option and

will not be used in all applications.

5. Manual Film Tray Release button – Allows the film tray to be removed without

the DryView 8600 Imager being powered on. Insert the film saver before using

this button or the film will be exposed.

Figure 2-1. DryView 8600 Laser Imager – Controls and Indicators

DryView 8600 User Guide

2-2

8186546 1999 June Rev. A

Local Panel Controls and Indicators

The numbered descriptions below correspond to the numbered callouts in

Figure 2-2.

1. Display – Uses a two-line, alphanumeric display to provide status, setup, and

test information on the DryView 8600 Imager.

2. A and B Setup (buttons) – Select one of the two input modules for parameter

setup or changes. (B Setup is not currently used.)

3. Test (button) – Accesses the test menu.

4. Down and Up Arrows (buttons) – Scroll the display and move the display

cursor, when present.

5. Exit (button) – Allows user to exit any menu or local panel operation.

6. Enter (button) – Accepts entry. Executes commands or advances menu.

7. Numeric Keypad (buttons) – Allows user to enter numeric information.

8. Clear (button) – Clears (deletes) entries.

Figure 2-2. Local Panel

Section 2 – Controls and Indicators

2-3

1999 June Rev. A 8186546

(Optional) Remote Keypad Controls and Indicators

The numbered descriptions below correspond to the numbered callouts in Figure

2-3.

1. Imager Ready (indicator) – When illuminated, indicates that the imager is

operational.

2. Check Imager (indicator) – Flashes to indicate a fault or out of film condition.

An associated error message is displayed on the local panel.

3. Memory Full (indicator) – When illuminated, indicates that there is insufficient

memory available to acquire another image. This condition is reported only to the

user whose image memory area is full. The condition should automatically

correct itself as the imager prints films and frees memory space.

1

2

3

4

5

6

7

8

9

10

Figure 2-3. Remote Keypad (Optional)

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Kodak Kodak DryView 8600 User manual

Kodak Kodak DryView 8600 User manual

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