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Konica Minolta Drypro Sigma 2 Laser Imaging System: Film Types

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0% found this document useful (0 votes)
1K views95 pages

Konica Minolta Drypro Sigma 2 Laser Imaging System: Film Types

Uploaded by

eduardo davalos
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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KONICA MINOLTA DRYPRO SIGMA 2

Laser Imaging System


Film Types
The DRYPRO SIGMA 2 Laser Imager prints on KONICA MINOLTA Medical Imaging
Film.

Intended Use
The DRYPRO SIGMA 2 Laser Imaging System is intended to provide high-
resolution hard copy images from digital imaging source output signals onto
KONICA MINOLTA MEDICAL IMAGING FILM SD-S series. The device is intended
for use with a variety of digital modalities, including, but not limited to, CR
(Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography),
MRI (Magnetic Resonance Imaging), and FFDM (Full Field Digital Mammography).
Image resizing is used to preserve true geometric size images. The images are to
be used for medical diagnosis and referral to physicians and their patients.

Getting Started
Your imager comes with several publications to help you get started quickly and
safely. Locate the following publications:
• Safety Manual (AD3436): Review this manual first to understand how to
position and work with the imager safely and within regulations.
• Pre-Installation Manual (AD3440): Use the checklist to ensure that your site is
ready for the installation.
• Operation Manual (AD3435): Refer to this manual for a product overview, use
instructions, and troubleshooting tips.
• Quick Reference Card (AD3439): Keep this card in a convenient place and
reference it as needed.
• Quality Control Manual for Mammography (AD4004): Apply the quality control
tests to the imager if you are printing mammography prints.
NOTE: Requirements for mammography quality control vary by region.

Pub No. AD3438_en, Rev. A, 2016-03-31


© KONICA MINOLTA, INC., 2016
Made in the USA.
KONICA MINOLTA, INC.
KONICA MINOLTA and DRYPRO are trademarks of KONICA MINOLTA, INC. 1 Sakura-machi,
Publication History: Hino-shi, Tokyo,
Rev A: First release. 191-8511, Japan
Operation Manual

Publication No. AD3435_en


2016-03-31
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.
Contents

1 Overview
Major Internal Assemblies............................................................................................................. 1-2
How the Imager Works ................................................................................................................. 1-3
Print Sequence ............................................................................................................................... 1-4
Supported Film Sizes ..................................................................................................................... 1-5
Mammography Imaging ............................................................................................................... 1-5
Automatic Image Quality and Processing .................................................................................... 1-5
Configure and Monitor the System (Using the Web Portal)....................................................... 1-6
Installation, Setup, and Safety...................................................................................................... 1-6
User Manual Conventions ............................................................................................................. 1-7

2 Basic Operating Tasks


The Display Screen......................................................................................................................... 2-2
Imager Power................................................................................................................................. 2-5
Power Switch Location ............................................................................................................ 2-5
Start the Imager....................................................................................................................... 2-6
Emergency Shutdown or Power Loss ..................................................................................... 2-7
Restart the Imager................................................................................................................... 2-7
About the Film Cartridges............................................................................................................. 2-8
Replace an Empty Film Cartridge ........................................................................................... 2-9
Load a Different Film Size to Match a Print Request .......................................................... 2-10
Delete All Pending Jobs with Unavailable Media Size or Type ................................................ 2-12
Calibrate the Imager for the Loaded Film ................................................................................. 2-13
Automatic vs. Manual Calibration ........................................................................................ 2-13
Test Prints..................................................................................................................................... 2-14
Make a SMPTE Image Print ................................................................................................... 2-14
Make a Mammography Test Print—Mammography Film Loaded ..................................... 2-14
Open or Remove a Cover ............................................................................................................ 2-16
Access More Functionality with the Web Portal........................................................................ 2-17
Access the Web Portal ........................................................................................................... 2-17

3 Maintenance and Troubleshooting


Overview: Status and Error Messages and Codes ........................................................................ 3-2
Preventive Maintenance ............................................................................................................... 3-3
About the Filter ............................................................................................................................. 3-3
Replace the Filter..................................................................................................................... 3-4
550 Code and Maintenance Symbol............................................................................................. 3-5
Error Indicators on the Display Screen ......................................................................................... 3-6
Recognize and Handle a Calibration Error .................................................................................. 3-6
Handle a Required Restart ............................................................................................................ 3-7

AD3435_en | 2016-03-31 i
Recognize and Handle a Film Jam................................................................................................ 3-8
Using the Web Portal to Gain More Information on Errors ....................................................... 3-9
Subsystem Error Codes and Messages ........................................................................................ 3-10
DICOM (Digital Imaging and Communications in Medicine).............................................. 3-10
Machine Control System (MCS) Imager Status Messages .................................................... 3-11
Film Supply Status Messages ................................................................................................. 3-12
Job Manager Status Messages .............................................................................................. 3-14
Condition Codes .................................................................................................................... 3-15
Film Jam Indication, Areas, and Interlocks................................................................................. 3-22
Clear Film Jam in Area 1 – Error Code 116 (Web Portal code 21116/23116)............................ 3-26
Clear Film Jam in Area 2 – Error Code 302 (Web Portal code 26302)....................................... 3-27
Clear Film Jam in Area 2 – Error Code 325 (Web Portal code 26325)....................................... 3-29
Clear a Film Jam in Area 2 or 3 – Error Code 326 (Web Portal code 26326)............................ 3-31
Film Jam in Area 3 – Error Code 543 or 544 (Web Portal code 26543 or 26544)..................... 3-33
Display Screen is Not Functional................................................................................................. 3-36
Call for Support ........................................................................................................................... 3-36

4 Film Technical Information


Spectral Sensitivity of the Film...................................................................................................... 4-1
Film Image Quality ........................................................................................................................ 4-2
Environmental Impact ................................................................................................................... 4-2
Undeveloped Film Handling and Storage.................................................................................... 4-3
Developed Film Handling and Archival........................................................................................ 4-3
Exposing Film to Moisture ............................................................................................................ 4-4
Odor Dissipation ............................................................................................................................ 4-4
Heat Dissipation............................................................................................................................. 4-4
Film Recycling ................................................................................................................................ 4-4

5 Specifications
Equipment Specifications.............................................................................................................. 5-1
Operating Requirements............................................................................................................... 5-1
Environmental/Location Requirements........................................................................................ 5-2

Publication History

ii AD3435_en | 2016-03-31
1 Overview
The Laser Imaging System is a continuous-tone laser imager with an internal
photothermographic film processor. Heat, rather than photo chemicals, is used to
develop the film. This easy-to-use and reliable imager provides high-quality prints. Use
the prints from this system for:
• Diagnostic purposes to determine patient treatments, including imaging for full field
digital mammography
• Referral, sharing, or educational purposes
The system receives and prints from qualified image sources such as medical electrical
equipment (modalities) and workstations over the network. You can send print jobs
simultaneously from multiple image sources. The open design lets you connect to
modalities of all types and vendors.

1 Top cover. Covers the processor rollers. The top cover is interlocked.

2 Display screen. Provides an interface to the imager, with status and error information.

3 Right cover. Protects sensitive electronic equipment. The right cover is only accessed by
service personnel.

4 Film supply door. Covers the upper and lower film supplies.

5 Left cover. Covers the left side of the imager. You might remove the left cover to clear
an occasional film jam. The left cover is interlocked.

AD3435_en | 2016-03-31 1–1


Overview

6 Filter door. Covers the replaceable filter.

7 Exit tray. Holds multiple sheets of processed film. Extend the exit tray to hold large film
(35 x 43 cm/14 x 17 in. and 35 x 35 cm/14 x 14 in.) as it finishes printing.

Major Internal Assemblies

1
11 2

10

H241_0003DCA
6 5 H241_0003DC

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Overview

1 Airflow manifold. Removes heat and processing odors from the processor assembly.

2 Exit rollers. Move the film from the processor area to the exit tray.

3 Optics module. Writes the image onto the film while the film is moved through the
exposure transport.

4 Deodorant filter. Absorbs potential odors that may be caused by heat processing.

5 Accumulator. Receives the film before it is imaged. The film is sent from the accumula-
tor up to the optics module, and then to the processor assembly where the heat is
applied to process the image.

6 Rollback assemblies (upper and lower). Roll the film cartridge cover back so the
pickup assembly can lift the film. When the imager is not printing, the cover is closed
over the film cartridge to protect the film from light.

7 Feed rollers. Move the film through the imager.

8 Pickup assemblies (upper and lower). Lift a single sheet of film from the supply car-
tridge and feed it into the rollers.

9 Transport guides. Orient the film while moving it (the film) from the supply to the
imaging portion of the imager.

10 Exposure transport. Moves the film past the scanning laser beam.

11 Processor drum. Provides the heat that processes the image on the film.

How the Imager Works


The imager receives, processes, manages, and prints the images on film. The imager has
limited storage to hold a small number of digital images. As images are received for
printing, they are stored in memory, placed in a sequential print queue, and printed in
order. The imager can continue to accept incoming print jobs even if temporarily unable
to print (if the film supply is empty, etc.).
During normal operation, the imager requires very little attention. It prints automatically
in response to print requests from the configured image sources. Information sent with
the images by the image source, such as film type and size and image quality settings, is
applied unless you set the imager to override information that comes from the image
source.

AD3435_en | 2016-03-31 1–3


Overview

Print Sequence

Each time the imager receives a print request, the following print sequence occurs. The
arrows show the film path.
1. Suction cups in the pickup area lift a single sheet of film out of one of the supply
cartridges and feed the film into the transport rollers.
2. The transport rollers move the film down to the accumulator area.
3. The film reverses direction and moves up during imaging (as the optics module writes
the image onto film). Then the film moves up to the processor.
4. As the film passes over the processor drum, the heat generated by the drum develops
the film.
5. The exit rollers move the developed film to the exit tray.

1–4 AD3435_en | 2016-03-31


Overview

Supported Film Sizes


The imager is available in different configurations; the following film sizes can be
supported:
• 35 x 43 cm (14 x 17 in.)
• 28 x 35 cm (11 x 14 in.)
• 25 x 30 cm (10 x 12 in.)
• 20 x 25 cm (8 x 10 in.)
Blue and mammography film types may be available.

Mammography Imaging
To manage and support mammography imaging, the imager provides these features.
• You can load mammography film in one or both film supplies.
• The imager can be configured to print mammography images exclusively on
mammography film. If a mammography image request is received, and:
– a cartridge with mammography film is not loaded,
and/or
– the requested mammography film size is not loaded,
then the imager will request the appropriate film size and type. You must load the
requested size and type to print the mammography job.
• Several mammography-specific test prints are provided, including a test print for the
routine calibration of mammography film (for example, a density wedge print). The
default mammography test print is configured during installation and can be
changed from the Web Portal.

Note
See the Mammography Quality Control Manual for more information. Requirements for
mammography quality control vary by region.

Automatic Image Quality and Processing


An internal densitometer enables the imager to automatically adjust image processing
parameters using Automatic Image Quality Control (AIQC) to produce an optimal image.
The imager adjusts these parameters each time it prints a calibration film.
A calibration film is printed when:
• A film cartridge is inserted in the imager with film of a new lot number.
• You request a calibration film at the display screen or the Web Portal.
• A film cartridge is inserted into the imager for which a current calibration is not
stored.

AD3435_en | 2016-03-31 1–5


Overview

Related topics:
Calibrate the Imager for the Loaded Film

Configure and Monitor the System (Using the Web


Portal)
The Web Portal is your interface to additional features. In addition to the installation and
setup of your system, you can view and manage the imager's connections over the
network, configure features, view error messages, and access general status information
at the Web Portal. You can also check film count, film size, and film type.
Related topics:
Access the Web Portal

Installation, Setup, and Safety


Installation and setup must be performed by a qualified service provider. Contact a
qualified service provider with any questions.
See the Safety Manual, available on the publications disc, for instructions to safely use
the imager and for agency compliance.

1–6 AD3435_en | 2016-03-31


Overview

User Manual Conventions


Note
Notes provide additional information, such as expanded explanations, hints, or reminders.

Important
Important notices highlight critical policy information that affects how you use this manual and
this product.

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

Laser Warning
Laser warnings warn personnel that access to laser radiation is possible and all personnel must
avoid direct exposure to the beam.

AD3435_en | 2016-03-31 1–7


2 Basic Operating Tasks
During normal operation, the imager receives and automatically prints images sent by
modalities over a network. Very little interaction is required. You can do the following:
• Turn the power on (|) and off (0).
• Load the film cartridges.
• Monitor the display screen for status and operating conditions.
Sometimes it will be necessary to perform preventive maintenance, filter replacement,
and other corrective actions such as a restart.
You also may access the Web Portal to perform additional configuration, optimize image
quality, or do troubleshooting tasks.
Related topics:
Maintenance and Troubleshooting
Access More Functionality with the Web Portal

AD3435_en | 2016-03-31 2–1


Basic Operating Tasks

The Display Screen


The display screen communicates the status of the imager.

Figure 1: Display screen: normal state, processing a print job from the upper supply. In this
example, there are 86 sheets of film in the upper cartridge and 113 sheets in the lower cartridge.

Symbol or code Description

Upper and lower Film counts. Displays the number of films that are remaining in the upper and
left side lower film cartridges.
If a blue number does not display while the imager is powered on, the associated
film cartridge is not inserted (or not fully inserted) into the imager.

Center right Error or status code. The 3-digit code displays when the error or status condition is
present. If the imager is on and a 3-digit code does not display, the imager is oper-
ating normally.
• If a print job requires a different film size and/or type from the loaded films, the
requested size and type displays along with the Film size symbol. For mammog-
raphy film, an M displays in front of the film size, and B indicates the blue base
film. Load the requested film size and type.
• When the imager is starting, a countdown displays the number of minutes until
the imager will be ready to print (for example, -4 means 4 minutes until the
imager will be ready to print).

Indicator light The light indicates the active cartridge. For example, when printing from the upper
supply, the indicator light appears next to the upper film count.
• When green, operation is normal.
• When amber, the light indicates that there is an issue with the film supply, such
as a jammed film.

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Basic Operating Tasks

Symbol or code Description

Power When the symbol is green, the power is on and the imager is ready to print.
• The symbol flashes while the imager is processing, calibrating, or making a test
print.
• When the symbol is amber, the imager is not ready to print. Examples are when
the imager has just been started, when a film cartridge is empty or jammed, and
when a cover is removed.

Calibrate and Test Calibration might be needed if the symbol is on and code 624, 631, or 632
Print appears. Press the symbol to calibrate the upper or lower film cartridge.
• The symbol flashes while the calibration is in process, when making a test print
(upper or lower), and when you initiate a filter reset.
• When amber, there is an error such as a failed calibration. The indicator light
associates the error code to the film cartridge. Depending on the issue, you may
be able to keep printing (631 or 632 error), or it might be necessary to load a
different film cartridge (624 error).
To make a test print, press and hold the Calibrate symbol for three seconds until
the imager beeps twice. The test print varies depending on the type of film.

Pause
Important
To avoid exposing the film to light, do not open the film supply door until the Pause
symbol is off. Wait until the symbol is off to replace a cartridge.
• During most normal operation, including when the imager is idle, the symbol is
off.
• The symbol is on while the imager is processing images, test prints, and during
calibration.
• The symbol flashes when a film cartridge cover is in the process of being opened
(rolled back) or closed.
If the Pause symbol is on, you can press the symbol to temporarily pause printing.
Any jobs in progress finish printing, then the film cartridge cover closes. When the
Pause symbol turns off, you can open the film supply door.

Film Size When this symbol appears, the requested print job requires a different film size
and/or type. The required film size/type flashes in the location of the error or status
code.
You can also press this symbol for three seconds, until the imager beeps twice, to
cancel all pending print jobs that require an unavailable media size and/or type.

Restart Restart the imager. An error code also displays to indicate the reason for the
restart.

AD3435_en | 2016-03-31 2–3


Basic Operating Tasks

Symbol or code Description

Film Jam Film is jammed from the upper or lower cartridge. The error code confirms the film
jam and gives direction on where to find the film inside the imager. The indicator
light associates the error code with the film cartridge.

Maintenance Preventive maintenance is required. An error code also displays to indicate the
action to take.

Related topics:
Maintenance and Troubleshooting
Load a Different Film Size to Match a Print Request
Calibrate the Imager for the Loaded Film
Delete All Pending Jobs with Unavailable Media Size or Type
Test Prints
Restart the Imager
Preventive Maintenance

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Basic Operating Tasks

Imager Power

Power Switch Location

1
H241_0008GCA
H241_0008GC

The power switch (1) is on the lower portion of the imager’s back panel (2).

AD3435_en | 2016-03-31 2–5


Basic Operating Tasks

Start the Imager


1. Press the power switch on the back of the imager on.

2. Wait as the imager warms up.


The warm-up period might last up to 30 minutes. The display screen shows the
progress as the imager becomes ready to print.

Figure 2: The imager counts up to zero (0) to indicate how soon the imager will be ready to
print. In this example, the imager will be ready to print in 7 minutes. The amber power symbol
also indicates that the imager is not ready to print.

The warm-up period varies depending on the amount of time the imager has been
off and the ambient temperature. During the warm-up period, the imager can
receive and store images but cannot print films.
When the imager reaches operating temperature, the display screen changes to show
that the system is ready to print, and the imager prints any images that were received
during the warm-up period.

Figure 3: The green power symbol indicates that the imager is ready to process job requests.

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Basic Operating Tasks

Emergency Shutdown or Power Loss


In the event of a power loss, or if an emergency requires an immediate shutdown of the
imager, films in process will not be completed. However, when power is restored, the
imager will restart. After warming up, the imager automatically reprints any films that
were in process when the power was interrupted.

Restart the Imager


If the imager encounters an error that is usually corrected with a restart, the display
screen shows the Restart symbol.

Figure 4: A restart is required, and the error code indicates the error condition.

Note
Check the Troubleshooting chapter or the Quick Reference Card to identify the error code.
1. Press the power switch on the back of the imager off.

2. Press the power switch on.

If the error does not clear after the restart, it might be necessary to contact a qualified
service provider.

AD3435_en | 2016-03-31 2–7


Basic Operating Tasks

About the Film Cartridges


Film Count
The upper and lower film counts appear on the display screen.

Figure 5: In this example, the upper cartridge has 86 sheets of film, and the lower has 113.

Size/Type of the Loaded Film


To check the size of the loaded film, open the film supply door and view the loaded
cartridges.

Note
Make sure the Pause symbol is off before you open the film supply door.

Film Count Flashes “0”


When either cartridge is empty, the film count flashes “0.” Replace the cartridge.

Figure 6: In this example, the upper film cartridge is empty. Replace the upper cartridge.

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Basic Operating Tasks

Film Size/Type Flashes


When a film size/type is requested that is not loaded, the Film Size symbol (1) appears,
and the requested film flashes (2). Change the loaded film to match the print request.

Figure 7: View and load the requested film size/type in the error code location (2). In this
example, “M” represents a request for mammography film.

Related topics:
Replace an Empty Film Cartridge
Load a Different Film Size to Match a Print Request

Replace an Empty Film Cartridge


When a film cartridge is empty, the film count appears as 0 on the display screen.

Note
Before you load a new film cartridge, make sure that the Pause symbol is off. When the imager
is idle, the symbol is off. When the film cartridge cover is open, the symbol is on. To avoid
exposing the film to light, do not open the film supply door until the Pause symbol is off.
1. If the Pause symbol is on, press the symbol to close the film cartridge cover.

2. Open the film supply door (1).


3. Hold the edges of the film cartridge and lift the empty cartridge out of the film
supply.
4. Discard the empty cartridge.
5. Insert the new film cartridge. Align the cartridge (2) with the label facing up and the
perforations (3) leading into the imager. Set the leading edge (4) on the cartridge

AD3435_en | 2016-03-31 2–9


Basic Operating Tasks

guides (5), and then slide the film cartridge into the imager to engage the detents (6)
in the bottom of the cartridge.

5
3

6
H241_0006BCB
1 H241_0006BC

6. Close the film supply door.


7. Check that the display screen changes to reflect the new film count. A new film
cartridge contains 125 sheets.

Load a Different Film Size to Match a Print Request


If a print request requires a different film size, the requested film size flashes on the
display screen. Change the installed film to match the print request.
• M = mammography film
• B = blue base film

Figure 8: The requested film size flashes, and the Film Size symbol indicates the need to load a
different film size and/or type. In this example, mammography 10 x 12 in. film is requested. The
amber text changes between “M10” and “M12.” Load it to continue with the print request.

1. If the Pause symbol is on, press it and wait until it turns off.
2. Open the film supply door (1).
3. Hold the edges of the film cartridge and lift the cartridge out of the film supply.

2–10 AD3435_en | 2016-03-31


Basic Operating Tasks

4. Insert the new film cartridge. Align the cartridge (2) with the label facing up and the
perforations (3) leading into the imager. Set the leading edge (4) on the cartridge
guides (5), and then slide the film cartridge into the imager to engage the detents (6)
in the bottom of the cartridge.

5
3

6
H241_0006BCB
1 H241_0006BC

5. Store the removed film cartridge.


6. Close the film supply door.
7. Check that the requested film size/type no longer displays on the screen.

AD3435_en | 2016-03-31 2–11


Basic Operating Tasks

Delete All Pending Jobs with Unavailable Media Size


or Type
You might cancel all the pending print requests if the wrong media has been selected.
1. Press and hold the Film Size symbol for three seconds.

Figure 9: The Film Size symbol indicates that there is at least one job that requires a different
size or type of media.

2. All print requests for an unavailable media size or type are deleted from the queue.

Note

• A print request that cannot be printed is automatically deleted from the imager. This
situation could be caused by invalid parameters from the modality, etc.
• If a job is not printable, the imager will eject a blank film into the exit tray.

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Basic Operating Tasks

Calibrate the Imager for the Loaded Film

Automatic vs. Manual Calibration


The imager automatically calibrates film with a new media lot number.
The calibration initiates a test print with a step wedge pattern. The pattern has a series
of 21 step wedges of increasing optical density.
Occasionally, it will be necessary to manually calibrate the imager for the film. Run a
calibration manually when:
• A calibration error occurred, indicated by codes 624, 631, or 632 on the display screen.
The imager will continue to print with a 631 or 632 error. A 624 error requires you to
retry calibration and/or replace the film cartridge.
• A Not Calibrated message appears on the Web Portal Home screen.

Manual Calibration

1. Press the Calibrate symbol for the film cartridge (upper or lower).

Figure 10: In this example, the imager is running a calibration on the lower cartridge. The
Calibration and Power symbols both flash while the calibration is in progress.

2. When the symbols stop flashing, the calibration is complete.

Note
If the Calibration symbol turns from blue to amber, there was a problem with the calibration
process. An error code will display, and the indicator light associates the error code to the film
cartridge. When a calibration error occurs, it might be necessary to address the error before you
can continue printing to that film cartridge.
Related topics:
Error Indicators on the Display Screen

AD3435_en | 2016-03-31 2–13


Basic Operating Tasks

Test Prints
You can initiate a test print to verify operation. The type of test print varies depending
on whether you have blue or mammography film loaded.
There are several options for mammography calibration prints; the default is configured
during installation. If you need a different type of test print for mammography film, you
can change the default at the Web Portal.

Make a SMPTE Image Print


The SMPTE test pattern is available when blue (non-mammography) film is loaded.
1. Press and hold the Calibrate symbol for the film cartridge (upper or lower) for three
seconds.

Figure 11: In this example, the imager is printing a SMPTE test image from the upper cartridge.
The Calibration and Power symbols both flash while the test print is in progress.

2. When the symbols stop flashing, the SMPTE test print is complete.

Make a Mammography Test Print—Mammography Film Loaded

About Mammography Quality Control

There are several options for mammography calibration prints, for example, QC wedges,
multipurpose QC, TG18-PQC or QC, TG18-UN10 or 80, or TG18-UNL10 or 80. The default
is configured during installation, and you can change it any time from the Web Portal.
The QC step wedge test print provides density feedback at the conclusion of the test print
cycle, letting you track and record density variations on mammography film. Four
nominal output densities have been selected for control charting purposes:
• Step 1—Low density, not less than 0.45
• Step 2—High density, approximately 2.20
• Step 3—Minimum density (DMin) (Base + Fog)
• Step 4—Mid density, not less than 1.20

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Basic Operating Tasks

The density values for the last test print are recorded in the Web Portal, and you can
manually record them on the film for charting purposes.
See the Mammography Quality Control Manual for more information.

QC Step Wedge Test Print

1. Press and hold the Calibrate symbol for the film cartridge (upper or lower, where the
mammography film is loaded) for three seconds.

2. The film prints with the four density steps. The display panel shows the Step 1 values.
3. Press the Calibrate symbol again to view the results of Step 2. Repeat for Steps 3–4.

Figure 12: In this example, the imager has printed a QC step wedge test print. The Step number
identifier displays at the upper left (1–4), and the density value displays on the right side (1.40 in
this example). Record the values, if desired, on the film.

4. Press the Pause symbol to return to normal operation.

AD3435_en | 2016-03-31 2–15


Basic Operating Tasks

Open or Remove a Cover


You can open or remove the imager’s top cover, left cover, film supply door, and filter
cover. The covers are protected with an interlock mechanism to keep the imager from
printing when they are open. The imager is not operational when an interlock is open.
Code 701 alerts you that a cover and an interlock are open, and internal power has been
removed from the operator accessible areas.

Figure 13: The 701 error indicates that a cover is open.

You might need to remove the:


• Film supply door, top cover, or left cover to search for film jams
• Filter cover to replace the filter
Related topics:
Recognize and Handle a Film Jam
Replace the Filter

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Basic Operating Tasks

Access More Functionality with the Web Portal


The Web Portal is your interface to additional features. In addition to the installation and
setup of your system, you can view and manage the imager's connections over the
network, configure features, view error messages, and access general status information
at the Web Portal. You can also check film count, film size, and film type.
Troubleshooting tools include:
• Optimization of image quality for modalities.
• Diagnostic utilities, including backup and restore.
The Web Portal provides an online Help system and a user’s guide to assist you.

Access the Web Portal


Prerequisites:
A personal computer (desktop or laptop) connected to the network

1. On a desktop or laptop computer, start WINDOWS INTERNET EXPLORER (IE).

Note
Only IE 6, 7, and 8 have been qualified with the imager. See the note below if using IE 8 or 9.
2. In the address field, type http://<imager’s IP address>

Note
If you do not know the IP address, check with your network administrator or the person who
installed the imager.
3. Click Go.
The Web Portal opens to the Device Status (Home) screen.
• The main window shows general status, the number of print jobs queued, the
number of jobs waiting for film, and the film count for each cartridge.
• The center panel displays the screens where you view and perform tasks. Online
Help is available by selecting Documentation from the left panel, and the Help
icon provides context-sensitive Help for fields and pages.
• The left panel also provides the links to all other screens.

Note
If you are using WINDOWS INTERNET EXPLORER 8 or 9, place the INTERNET EXPLORER (IE)
window into compatibility view. After you have opened the IE window, click the Compatibility
View toolbar button. This will correct some potential viewing issues. If the icon is not on the
toolbar, select Compatibility View from the Tools menu.

AD3435_en | 2016-03-31 2–17


3 Maintenance and Troubleshooting
Use the information in this chapter to keep the imager in the best condition and to
correct minor problems.
• Overview: Status and Error Messages and Codes—Review this overview for
information about where and when the messages and codes appear.
• Preventive Maintenance—Learn how to respond to the Maintenance symbol.
• Error Indicators on the Display Screen—Learn about the amber and red error symbols
• Using the Web Portal to Gain More Information on Errors—Learn how and why to
access the Web Portal.
• Subsystem Error Codes and Messages—Refer to this section for error codes and
messages.
• Condition Codes—Refer to this section for all condition codes.
• Film Jam Indication, Areas, and Interlocks—See instructions to locate and correct
jammed films.
• Display Screen is Not Functional—Learn what to do if the display screen is not
responding.
• Call for Support—Learn how to get help.

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Maintenance and Troubleshooting

Overview: Status and Error Messages and Codes


The imager detects errors and other conditions and reports them to you in multiple ways.
Some conditions require your action. This section provides a list of the codes, explains the
condition, and provides recommended actions when appropriate. View the codes:
• At the imager’s display screen, on the center right. The display screen reports
3-digit codes.
Some codes are associated with symbols on the display screen, such as the Film Jam
symbol, to help you quickly understand the condition.
• At the Web Portal. Access the Web Portal using your personal computer, keyboard,
and mouse to gain more information about the errors and conditions. Using the Web
Portal is optional, but you may find it useful. The Web Portal can report more
information than the imager’s display screen due to the limited size of the display
screen.
Related topics:
Using the Web Portal to Gain More Information on Errors

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Maintenance and Troubleshooting

Preventive Maintenance
Note
These conditions are also reported at the Web Portal.

About the Filter

Caution
In the U.S., exhausted filters are considered to be non-hazardous waste according to the US
Environmental Protection Agency Resource Conservation Recovery Act (RCRA). Municipality
owned and licensed solid waste management facilities are an appropriate disposal option.
Contact your local or state solid waste authorities to determine if additional disposal requirements
apply. In other regions, contact local or regional solid waste authorities for proper disposal
guidance.
The filter traps potential odors that are generated in the imager during film processing.
The filter must be replaced after 7500 prints. Keep at least one new filter available to
replace the used filter when needed.

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Maintenance and Troubleshooting

Replace the Filter


When the filter must be replaced, the display screen shows the 449 error code and the
Maintenance symbol.

1. Open the film supply door (1).


2. Remove the filter cover (2) by pulling out from the bottom of the cover.

H241_0004GCA
H241_0004GC

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Maintenance and Troubleshooting

3. Remove the filter by lifting it up and pulling it forward.

H241_0007AC

4. Install a new filter.


5. Re-install the filter cover.
6. To reset the imager for the new filter and to clear the Maintenance symbol, press and
then release the illuminated Maintenance and Calibrate symbols at the same time.

550 Code and Maintenance Symbol


If the imager needs a preventive maintenance service call, the 550 code and Maintenance
symbol appear:

When the 550 code displays, contact a qualified service provider.

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Maintenance and Troubleshooting

Error Indicators on the Display Screen


The imager can detect errors and other conditions that require a response. Some errors
or abnormal conditions are reported on the display screen in the form of condition codes
and symbols.

Note
These errors are also reported at the Web Portal.

Recognize and Handle a Calibration Error


When the calibration has failed, the display screen shows a 624, 631, or 632 error and the
Calibrate symbol is amber.

Figure 14: In this example, the amber indicator light and Calibration symbol indicate that
calibration of the film in the lower cartridge has failed.

The most common cause is a film-related problem. Depending on the cause, you may be
able to keep printing, but the imager may not be optimally calibrated for this film lot.
Attempt a manual calibration. If the calibration fails again, load a new film cartridge.
Related topics:
Calibrate the Imager for the Loaded Film

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Maintenance and Troubleshooting

Handle a Required Restart


When the Restart symbol appears, you must restart the imager.

Figure 15: The amber Power symbol, together with the Restart symbol, indicates that you must
restart the imager to continue printing.

1. Press the power switch on the back of the imager off.

2. Press the power switch on.

If the error does not clear after the restart, it might be necessary to contact a qualified
service provider.
Related topics:
Restart the Imager

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Maintenance and Troubleshooting

Recognize and Handle a Film Jam


When the Film Jam symbol appears, you must clear the jam before the imager can
continue to print. After the jam has been cleared, the imager will reprint the image on a
new sheet of film.

Figure 16: In this example, the red jam symbol alerts you to the jam, and the amber indicator
light shows you that the jam is related to the upper film cartridge. The error code also indicates a
film jam.

Related topics:
Film Jam Indication, Areas, and Interlocks

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Maintenance and Troubleshooting

Using the Web Portal to Gain More Information on


Errors
The Web Portal is your interface to additional functions on the imager. You can view and
correct error messages and access general status information at the Web Portal.

About Codes on the Web Portal and the Display Screen


The 3-digit error and status codes on the display screen are reported at the Web Portal
as 5-digit codes. The last three digits on the Web Portal codes match the three digits on
the display screen. For example, code 701 on the display screen is the same as code 20701
on the Web Portal. Use the information in this section to understand the information at
the display screen and/or at the Web Portal and to respond appropriately.
Related topics:
Access the Web Portal

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Maintenance and Troubleshooting

Subsystem Error Codes and Messages


Use the information in this section to interpret the codes and messages that appear on
the display screen and at the Web Portal.

DICOM (Digital Imaging and Communications in Medicine)


In response to a DICOM printer N-GET status request from a modality, a printer status
message and a printer status info message are returned to the requesting service class
user (SCU). Every error has an associated printer status info message. If more than one
error exists when a printer N-GET request is received, a status message is sent in response,
according to an established priority. The table shows the DICOM printer status and info
message.
Printer Status Printer Status Info Printer Status Printer Status Info

FAILURE ELEC DOWN WARNING BAD SUPPLY MGZ


PRINTER DOWN CALIBRATION ERR
PROC DOWN CHECK PRINTER
COVER OPEN
EMPTY MEDIASZ MEDIATP
FILM JAM
FILM TRANS ERR
PROC INIT
PRINTER INIT
PRINTER OFFLINE

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Maintenance and Troubleshooting

Machine Control System (MCS) Imager Status Messages


The table describes how the display screen and Web Portal indicate imager status:
Web Portal
Printer Status Display Screen (remote) Display DICOM Status Description

Service Mode Service Mode WARNING / The service over-


PRINTER ride switch is
OFFLINE enabled. The
imager is not
ready.

Offline Printing Disabled WARNING / Printing/delivery


PRINTER has been disabled.
OFFLINE

Failed (Code will vary) Failed See error An error occurred


tables that prevents print-
ing.

Self-test Self-test WARNING This occurs when


/PRINTER INIT power is first
applied to the
MCS.

Warming Warming=xx WARNING / The processor is


PROC INIT currently warming
up and will not be
ready to print for
xx minutes.

Cover is Cover Open WARNING / A imager cover is


Open COVER OPEN open. imager not
ready. (A side cover
could be off.)

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Maintenance and Troubleshooting

Web Portal
Printer Status Display Screen (remote) Display DICOM Status Description

Printing Printing NORMAL The imager is


printing.

Ready Ready NORMAL The imager is


online and the pro-
cessor has reached
operating tem-
perature.

Pause (car- Not Ready WARNING / The imager is com-


tridge close COVER OPEN pleting prints in
requested) progress.

Film Supply Status Messages


The table describes how the display screen and Web Portal indicate film supply status:
Film Supply
State Display Screen Web Portal Display Description

Failed Failed An error occurred that affects


normal operation. The film car-
tridge is currently not usable.
Reinsert the cartridge. If the
error recurs, insert a new film
cartridge.

Calibrating Calibrating A calibration is in progress for


this film cartridge.

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Maintenance and Troubleshooting

Film Supply
State Display Screen Web Portal Display Description

Film cartridge Empty and/or sheet The film cartridge is inserted


empty count of 0 but the sheet count is 0. Insert a
new film cartridge.

Manual Mode AIQC Off (with nor- The film in this cartridge does
mal tray informa- not meet Automatic Image
tion) Quality Control (AIQC) stan-
dards. However, the imager
prints if ready.

Invalid film car- Invalid Film Tray There is a film cartridge in the
tridge film supply, but it does not con-
tain a liner/RF tag. Install a new
film cartridge.

Ready Normal Tray Info The film cartridge is ready to


use.

Requires Cali- Requires Calibration The film cartridge must be cali-


bration brated before the imager can
print. Initiation of the calibra-
tion may require user action.

Film cartridge No Film Tray The film cartridge is not fully


not detected inserted into the imager. Insert
the cartridge.

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Maintenance and Troubleshooting

Film Supply
State Display Screen Web Portal Display Description

Not Ready Varies Not Ready When the conditions are cor-
rected, the imager can print.

Cartridge clo- Pause Requested You pressed the Pause button,


sure pending but the film cartridge has not
started to close because films
are still moving through the
imager. When the cartridge fin-
ishes closing, the Pause symbol
turns off and you can remove
the film cartridge.

Related topics:
Calibrate the Imager for the Loaded Film

Job Manager Status Messages


The table describes how the display screen and Web Portal indicate job status:
Job Manager Web Portal Dis-
Status Display Screen play Description

Active Not applicable Shows how many The imager is accepting


jobs having this DICOM job requests and film
status are queued is available for all current
jobs.

No Media Shows how many The imager is accepting


jobs having this DICOM job requests, but film
status are queued of the correct size and type
is not available for at least
one current job.

(Status Code shows


requested size)

Offline DICOM Offline The laser imager cannot


accept any DICOM job
requests. Restart the imager.

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Maintenance and Troubleshooting

Related topics:
Load a Different Film Size to Match a Print Request
Restart the Imager

Condition Codes
Condition codes are shown on the display screen in the order in which they are
generated. If there is more than one code associated with the current condition of the
imager, the first code is shown on the display screen for six seconds, while other codes in
the list display for three seconds as the list is cycled. You can also view these codes and
messages at the Web Portal.
Display Web
Screen Portal Web Portal Message Action

004 01004 MIM Core: Internal Software Error Restart the imager. If the error persists, call for
service.

005 20-005 Internal MCS Communications Restart the imager. If the error persists, call for
Failure service.

200 04200 MIM Core: Disk Full Load the requested film type and size for jobs
that are waiting for media. If the error persists,
call for service.

400 06400 MIM Core: Image Page Error Resend the print job from the image source. If
the error persists, call for service.

410 06410 MIM Core: Image Rendering Error Resend the print job from the image source. If
the error persists, call for service.

411 06411 MIM Core: Image Data Error Resend the print job from the image source. If
the error persists, call for service.

420 06420 MIM Core: Internal Software Error Resend the print job from the image source. If
the error persists, call for service.

430 06430 MIM Core: Internal Software Error Resend the print job from the image source. If
the error persists, call for service.

001 10001 MIS: Internal Software Error Restart the imager. If the error persists, call for
service.

003 10003 MIS: Image Buffer Error Restart the imager. If the error persists, call for
service.

015 10015 MIS: Database Error Restart the imager. If the error persists, call for
service.

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Maintenance and Troubleshooting

Display Web
Screen Portal Web Portal Message Action

910 10910 MIS: MCS Communication Failure Restart the imager. If the error persists, call for
service.

006 20006 Disconnected or faulty network Check and reconnect the network cable on
cable both ends.
Restart the imager. If the error persists, call for
service.

154 20154 MCS: Internal Communications Restart the imager. If the error persists, call for
Failure service.

155 20155 Incompatible MCS Printer Config- Restart the imager. If the error persists, call for
uration for Hardware service.

156 20156 Incompatible Software Versions Restart the imager. If the error persists, call for
Installed service.

209 20209 Laser Imager Opened During Self Replace/close the cover. Restart the imager.
Test If the error persists, call for service.

449 20449 None Change the deodorant filter.

550 20550 None Call service for preventive maintenance.

700 20700 None Restart the imager.


If the error persists, call for service.

701 20701 None Replace/close the cover.

704 20704 None The network connection to the imager has


been lost. Restart the imager.

705 20705 None The imager is restarting (for example, during a


software update). Wait until the restart is com-
plete.

706 20706 None A shutdown that was initiated remotely is


complete. Restart the imager.

915 20915 Internal Image Data Transfer Failed Restart the imager. If the error persists, call for
service.

919 20919 Internal Image Data Render Failed Restart the imager. If the error persists, call for
service.

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Maintenance and Troubleshooting

Display Web
Screen Portal Web Portal Message Action

002 21002 None No action. The error may remain until the film
cartridge is empty. The film cartridge is operat-
ing in manual mode and AIQC is off.

116 21116 Film Jam in Area 1U Clear the jam. See the procedure later in this
section.

116 23116 Film Jam in Area 1L Clear the jam. See the procedure later in this
section.

118 21118 Film Supply: Internal Hardware If the Pause symbol is on, press it to cover the
or Failure film cartridge. When the Pause symbol stops
23118 flashing, remove the film cartridge from the
imager. Then reinsert the film cartridge into
the imager. If the error persists, call for service.

119 21119 Film Supply: Internal Hardware If the Pause symbol is on, press it to cover the
or Failure film cartridge. When the Pause symbol stops
23119 flashing, remove the film cartridge from the
imager. Then reinsert the film cartridge into
the imager. If the error persists, call for service.

125 21125 Film Supply: Internal Hardware If the Pause symbol is on, press it to cover the
or Failure film cartridge. When the Pause symbol stops
23125 flashing, remove the film cartridge from the
imager. Then reinsert the film cartridge into
the imager. If the error persists, call for service.

139 21139 Film Supply: Unable to Identify If the Pause symbol is on, press it to cover the
or Film Cartridge film cartridge. When the Pause symbol stops
23139 flashing, remove the film cartridge from the
imager. Then reinsert the film cartridge into
the imager. If the error persists, call for service.

145 21145 Film Supply: Unsupported Film The imager does not support the loaded film
or Type type. Install a cartridge with a supported film
23145 type.If the error persists, call for service.

146 21146 Film Supply: Unsupported Film Size The imager does not support the loaded film
or size. Install a cartridge with a supported size.If
23146 the error persists, call for service.

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Maintenance and Troubleshooting

Display Web
Screen Portal Web Portal Message Action

175 21175 Rollback Failed to Engage Car- If the Pause symbol is on, press it to cover the
or tridge film cartridge. When the Pause symbol stops
23175 flashing, remove the film cartridge from the
imager. Then reinsert the film cartridge into
the imager. If the error persists, call for service.

177 21177 Rollback Home Sensor (S2U) Failed Open the film supply door, top cover, and left
to Activate in Specified Time cover. Manually close the upper film cartridge,
using the manual rollback knob, to prevent
the film from fogging. Reinstall/close the cov-
ers. If the error persists, call for service.

177 23177 Rollback Home Sensor (S2L) Failed Open the film supply door, top cover, and left
to Activate in Specified Time cover. Manually close the lower film cartridge,
using the manual rollback knob, to prevent
the film from fogging. Reinstall/close the cov-
ers. If the error persists, call for service.

178 21178 Film Cartridge Failed to Open If the Pause symbol is on, press it to cover the
or film cartridge. When the Pause symbol stops
23178 flashing, remove the film cartridge from the
imager. Then reinsert the film cartridge into
the imager. If the error persists, call for service.

624 21624 Film Supply: Film Calibration Fail- Calibrate again.


or ure If the error persists, insert a different film car-
23624 tridge.If the error still displays, restart the
imager. If the error persists, call for service.

631 21631 Film Supply: Film Calibration Fail- The minimum density of the film is too high.
or ure - Dmin Outside Target Calibration results for this film are outside the
23631 normal range. Printing will continue with
these parameters.
If the prints are not optimal, do the calibration
procedure again or insert another film car-
tridge.

632 21632 Film Supply: Film Calibration Fail- The maximum density of the film is lower than
or ure - Dmax Outside Target the target density. Calibration results for this
23632 film are outside the normal range. Printing will
continue with these parameters.
If the prints are not optimal, do the calibration
procedure again or insert another film car-
tridge.

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Maintenance and Troubleshooting

Display Web
Screen Portal Web Portal Message Action

931 21931 Upper Film Supply: Internal Com- Restart the imager. If the error persists, call for
munications Failure service.

931 23931 Lower Film Supply: Internal Com- Restart the imager. If the error persists, call for
munications Failure service.

931 25931 RFTag: Internal Communications Restart the imager. If the error persists, call for
Failure service.

302 26302 Film Jam in Area 2 Clear the jam. See the procedure later in this
section.

325 26325 Film Jam in Area 2 Clear the jam. See the procedure later in this
section.

326 26326 Film Jam in Area 2 or 3 Clear the jam. See the procedure later in this
section.

543 26543 Film Jam in Area 3 Clear the jam. See the procedure later in this
section.

544 26544 Film Jam in Area 3 Clear the jam. See the procedure later in this
section.

123 27123 Optics: Internal Hardware Failure Restart the imager. If the error persists, call for
service.

931 26931 RFTag: Internal Communications Restart the imager. If the error persists, call for
Failure service.

601 27601 Optics: Calibration Failed Restart the imager. If the error persists, call for
service.

604 27604 Optics: Calibration Failed Restart the imager. If the error persists, call for
service.

607 27607 Optics: Calibration Failed Restart the imager. If the error persists, call for
service.

611 27611 Optics: Internal Hardware Failure Restart the imager. If the error persists, call for
service.

646 27646 Optics: Internal Hardware Failure Restart the imager. If the error persists, call for
service.

650 27650 Optics: Internal Hardware Failure Restart the imager. If the error persists, call for
service.

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Maintenance and Troubleshooting

Display Web
Screen Portal Web Portal Message Action

931 27931 Optics: Internal Communications Restart the imager. If the error persists, call for
Failure service.

501 28501 Processor: Internal Hardware Fail- Restart the imager. If the error persists, call for
ure service.

509 28509 Processor Warm-up Failure Restart the imager. If the error persists, call for
service.

510 28510 Processor: Internal Hardware Fail- Restart the imager. If the error persists, call for
ure service.

551 28551 Processor Heater Failure Restart the imager. If the error persists, call for
service.

554 28554 Processor Over Temperature Restart the imager. If the error persists, call for
service.

931 28931 Processor: Internal Communica- Restart the imager. If the error persists, call for
tions Failure service.

924 29924 Densitometer: Internal Diagnostic Restart the imager. If the error persists, call for
Failure service.

925 29925 Densitometer: Internal Diagnostic Restart the imager. If the error persists, call for
Failure service.

931 29931 Densitometer: Internal Communi- Restart the imager. If the error persists, call for
cations Failure service.

931 36931 Local Panel: Internal Communica- Restart the imager. If the error persists, call for
tions Failure service.

935 36935 Local Panel: No Communications Restart the imager. If the error persists, call for
from MCS service.

Related topics:
Restart the Imager
Load a Different Film Size to Match a Print Request
Replace the Filter
550 Code and Maintenance Symbol
Calibrate the Imager for the Loaded Film
Clear Film Jam in Area 1 – Error Code 116 (Web Portal code 21116/23116)
Clear Film Jam in Area 2 – Error Code 302 (Web Portal code 26302)

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Maintenance and Troubleshooting

Clear Film Jam in Area 2 – Error Code 325 (Web Portal code 26325)
Clear a Film Jam in Area 2 or 3 – Error Code 326 (Web Portal code 26326)
Film Jam in Area 3 – Error Code 543 or 544 (Web Portal code 26543 or 26544)

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Maintenance and Troubleshooting

Film Jam Indication, Areas, and Interlocks


Jam Indications
When film is jammed, the display screen indicates a jam and an error code that provides
guidance on where to check for the jammed film.

Figure 17: In this example, the indicator light shows you that the jam is related to the upper
cartridge.

Note
These errors are also reported at the Web Portal.

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Maintenance and Troubleshooting

Jam Areas
The jam areas are referenced in the instructions to solve the jam.

1 2
4

H241_0002DC

Jam Areas Description

1 Upper supply

2 Lower film supply

3 Film path

4 Processor / densitometer

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Maintenance and Troubleshooting

Interlocks

H241_0002DC

Interlocks Description

1 Left cover

2 Film supply

3 Top cover

4 Filter cover

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Maintenance and Troubleshooting

Roller Knobs
For some jams, you can remove the film by turning a knob to move the film out of the
imager. If film becomes misplaced around the film cartridge, it might be necessary to
manually cover the cartridge. See details in the film jam instructions.

Figure 18: Imager left side—Knobs for manual film removal and film cartridge closure

H241_0002DC

Knobs Description Knobs Description

1 Exit roller 4 Rollback knob—upper cartridge

2 Processor drum 5 Vertical transport

3 Exposure transport 6 Rollback knob—lower cartridge

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Maintenance and Troubleshooting

Clear Film Jam in Area 1 – Error Code 116 (Web Portal


code 21116/23116)
1. If the Pause symbol is on, press it and wait until it goes off.
2. Open the film supply door and remove the film cartridge from the imager.
3. Look in Area 1 (the upper or lower film supply) and Area 2 (Film Path) and remove
any film. Access this area from the front of the imager through the film supply.
4. If you have not found the jammed film, remove the left cover:

H241_0042ACA
H241_0042AC

a. Remove the top cover.


b. Turn the knurled knobs (1, 2) by hand.
5. Check for any jammed film. Remove any loose film.
6. If you have not found the jammed film, take the film cartridge to a dark room and
carefully pull back the cartridge cover. Remove any misplaced films and then replace
the cover.
7. Reinsert the film cartridge in the imager.
8. Reinstall/close the covers.

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Maintenance and Troubleshooting

Clear Film Jam in Area 2 – Error Code 302 (Web Portal


code 26302)
1. If the Pause symbol is on, press it and wait until it goes off.
2. Remove the left cover:

H241_0042ACA
H241_0042AC

a. Open the film supply door.


b. Remove the top cover.
c. Turn the knurled knobs (1, 2) by hand.

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Maintenance and Troubleshooting

3. Look for and remove any jammed film:


a. Remove the film cartridge, and check for any misplaced film in the imager.
b. Remove any loose film near, in, or partially in the cartridge.
c. If the film is not loose, carefully turn the exposure transport knob (1) and the
vertical transport knob (2) clockwise to remove the film from the rollers:

H241_0002DC

d. Reinsert the film cartridge in the imager.


4. Reinstall/close the covers.

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Maintenance and Troubleshooting

Clear Film Jam in Area 2 – Error Code 325 (Web Portal


code 26325)
1. If the Pause symbol is on, press it and wait until it goes off.
2. Remove the left cover:

H241_0042ACA
H241_0042AC

a. Open the film supply door.


b. Remove the top cover.
c. Turn the knurled knobs (1, 2) by hand.
3. Reach into Area 2 and remove any film.

AD3435_en | 2016-03-31 3–29


Maintenance and Troubleshooting

4. If the film is not loose, carefully turn the exposure transport knob (1) and the vertical
transport knob (2) clockwise to remove the film from the rollers.

H241_0002DC

5. Reinstall/close the covers.

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Maintenance and Troubleshooting

Clear a Film Jam in Area 2 or 3 – Error Code 326


(Web Portal code 26326)
1. If the Pause symbol is on, press it and wait until it goes off.
2. Remove the left cover:

H241_0042ACA
H241_0042AC

a. Open the film supply door.


b. Remove the top cover.
c. Turn the knurled knobs (1, 2) by hand.

AD3435_en | 2016-03-31 3–31


Maintenance and Troubleshooting

3. Rotate the processor drum (1) and exit roller (2) knobs clockwise until a film exits the
imager.

H241_0002DC

4. If a film does not exit:


a. Reach into Area 2 and remove any film.
b. If the film is not loose, carefully turn the exposure transport knob (1) and the
vertical transport knob (2) clockwise to remove the film from the rollers.

H241_0002DC

5. Reinstall/close the covers.

3–32 AD3435_en | 2016-03-31


Maintenance and Troubleshooting

Film Jam in Area 3 – Error Code 543 or 544 (Web Portal


code 26543 or 26544)
1. If the Pause symbol is on, press it and wait until it goes off.
2. Remove any film that is jammed in the exit tray.
3. Remove the top cover and remove any films.
4. If you have not found any jammed film, remove the left cover:

H241_0042ACA
H241_0042AC

a. Open the film supply door.


b. Turn the knurled knobs (1, 2) by hand.

AD3435_en | 2016-03-31 3–33


Maintenance and Troubleshooting

5. Rotate the exit roller knob (1) clockwise until a film exits the imager.

H241_0002DC

6. Pivot the heat shield (1) open and check for jammed film in the processor drum (2)
area.

2
1

H221_6034GCA
H221_6034GC

3–34 AD3435_en | 2016-03-31


Maintenance and Troubleshooting

7. If necessary, carefully rotate the processor drum knob (1) clockwise and remove any
film.

H241_0002DC

8. Reinstall/close the covers.

AD3435_en | 2016-03-31 3–35


Maintenance and Troubleshooting

Display Screen is Not Functional


If the display screen is not responding, use the power switch on the imager to turn power
off, and then on. If the display screen is still non-responsive, turn the imager off and
contact a qualified service provider.

Call for Support


If you cannot correct a condition and need help, call for support. Have the following
information ready when you call:
• Model number
• Error code from the display screen and/or code and error message from the Web
Portal

3–36 AD3435_en | 2016-03-31


4 Film Technical Information
This section describes the characteristics of Laser Imaging Film, not the operation of the
imager. The Laser Imaging Film is a high-resolution, infrared-sensitive,
photothermographic film designed specifically for the imager.

Spectral Sensitivity of the Film


The Laser Imaging Film is infrared sensitive and has been sensitized to the infrared laser
diode of the imagers. When handled according to instructions on the daylight-load film
package, safelights are not needed. If you remove undeveloped film from the
daylight-load package, you will need a darkroom setting and a green safelight.

AD3435_en | 2016-03-31 4–1


Film Technical Information

Film Image Quality


The Laser Imaging Film delivers diagnostic-quality, continuous-tone images along with
sharp alphanumerics and optimum contrast. This high-quality, silver-based film provides
health care providers with the same diagnostic information they are accustomed to
viewing—including spatial resolution, contrast, and gray levels. Because it is a totally dry
imaging process, there is no image quality variability due to wet chemistry.

Environmental Impact
Tests show that the Laser Imaging Film is not considered hazardous to the environment.
As a result, you can develop, recycle, and dispose of film with less impact on the
environment than if you were using wet-developed silver halide films.

Table 1: Laser Imaging Film—US Environmental Regulations Comparison

Wet (Silver Halide) Film Dry Film

Developer Fixer Wash Film Film

Product Regulations

OSHA MSDS Required Required Not required Not required Provided

DOT Hazardous Hazardous No limits No limits No limits

Use permits Local Local None None None

Disposal Regulations*†

EPA Hazardous Hazardous No No No

DOT Hazardous Hazardous No No No

* There is no Superfund liability with dry Laser Imaging Film.


† State and local laws vary. Consult appropriate regulations or authorities prior to disposal.

4–2 AD3435_en | 2016-03-31


Film Technical Information

Undeveloped Film Handling and Storage


To achieve consistent results up to the expiration date indicated on the film package, the
Laser Imaging Film must be stored in a cool, dry place (4–24 °C, or 39–75 °F) and properly
shielded from x-rays, gamma rays, or other penetrating radiation.
The film can withstand short-term temperature spikes (up to 35 °C, or 95 °F) for several
hours without any significant effect on film quality or performance. Temperatures above
35 °C (95 °F) will gradually diminish shelf life.
Hands must be clean, dry, and free of lotions. Handle film carefully by the edges to avoid
physical strains such as pressure, creasing, or buckling.

Developed Film Handling and Archival


Handling the Laser Imaging Film requires reasonable care. Spills, humidity, and other
moisture typically have no significant effect on developed films. However, prolonged
exposure to intense light or excessive heat (equal to or greater than 54.4 °C or 130.0 °F)
for more than three hours may cause some gradual darkening of images. Leaving films
in vehicles in hot climates for extended periods of time is not recommended.
For best results, store the film in sleeves when not being reviewed. The Laser Imaging
Film can be left on a light box for more than 24 hours. In extreme cases in which the light
boxes are exceptionally hot (equal to or greater than 49 °C or 120 °F), the manufacturer
recommends removing them prior to eight hours of continuous exposure.
Take care when using spotlight viewing for more than 30 seconds because temperatures
near the light source may exceed 82.2 °C (180.0 °F). Use in slide projectors is not
recommended due to the high temperatures generally found in these devices.
With dry technology, a small amount of final development occurs when the film exits the
imager and is initially exposed to ambient or view-box lighting. This is virtually
undetectable and has no effect on image quality (typically 0.02 change in density). This
small density increase is uniform and permanent upon full exposure of the film under
normal handling conditions (room light or view box).
The Laser Imaging Film has been tested and can be archived for more than 100 years
when stored at American National Standards Institute (ANSI) recommended storage
conditions (equal to or less than 25 °C or 77 °F). Processing film should be stored within
the temperature range of 16–27 °C, or 60–80 °F, and at 30–50 % RH. Developed films may
be stored at higher temperatures; however, that will reduce the number of years the film
can be stored. For example, storing films at a constant elevated temperature of 32.2 °C
(90.0 °F) may reduce archive capability to 30 years.

AD3435_en | 2016-03-31 4–3


Film Technical Information

Exposing Film to Moisture


The Laser Imaging Films typically withstand humidity, spills, and other forms of water
without any significant effect on image quality or film integrity. If needed, film can be
cleaned with a clean, damp cloth.

Odor Dissipation
Dry technology eliminates nearly all processing odors. While some low-level odors are
produced during the development process, they pose no known adverse health risks.
Processing odor levels are further reduced by non-hazardous, disposable filters in the
imager. The filters trap most low-level odors and prevent them from dissipating into the
work environment. To help maintain optimum performance, the filters require periodic
replacement. The imager requires no special venting.

Heat Dissipation
The imager uses controlled heat to develop the Laser Imaging Film. The heat has virtually
no effect on the air temperature of the work area. The amount of heat dissipated into
an area during a day is typically less than the heat generated by two to four 100-watt
light bulbs.

Film Recycling
According to the U.S. Environmental Protection Agency (EPA) standards, the Laser
Imaging Film is not considered hazardous and requires no special disposal procedures.
However, the film does contain silver and polyester that may be recovered by using one
of several recycling processes.

4–4 AD3435_en | 2016-03-31


5 Specifications
This section identifies the system specifications and the site requirements to operate the
imager.

Equipment Specifications
Unpacked

Height 66.6 cm (26.2 in.)

Width 62.6 cm (24.6 in.)

Depth 64.9 cm (25.5 in.)

Weight 79 kg (175 lb)

Note
The approximate weight of a 35 x 43 cm (14 x 17 in.) film
cartridge is 3.5 kg (7.7 lb).

Operating Requirements
• Allow 31 cm (12 in.) clearance around the top, sides, and back of the imager. This
space is required to let the imager perform normal operator functions.
• The table or counter must be level (within 1°) and capable of supporting the imager’s
weight.
• The recommended table or counter height is 71–76 cm (28–30 in.).
• Place the imager in an area with good ventilation. A small, confined room is not
recommended.
• Avoid placing the imager in direct or excessive sunlight (for example, near a large
window).

AD3435_en | 2016-03-31 5–1


Specifications

Environmental/Location Requirements

Temperature
• Operating: 15 to 33 °C (59 to 91 °F)
• Storage: -40 to 60 °C (-40 to 140 °F)

Relative Humidity
• Operating: 20–80 % RH, non-condensing
• Storage: 10–93 % RH, non-condensing

Altitude
-30 m (-100 ft) to 3,000 m (9,800 ft) above sea level

Surface Levelness
The surface where the imager is placed must be level within 1 °.

Environmental Effects
Acoustical noise:
• Less than 48 dB at 1 m during idle or standby
• Less than 75 dB momentary at 1 m during normal operation

Power Requirements
A power cord is provided with this equipment. All countries must use an
Agency-approved power cord with a plug type suitable for the country of use. Contact a
qualified dealer for help.
Connect the equipment to a power source that is suitable for the voltage and current
ratings shown on the rating label. The single-phase power source, with grounding, must
be provided within 2.5 m (8.0 ft) of the imager.
The wire must be insulation-rated for 600 V (ac). A dedicated line is recommended.

Network Requirements
The imager receives digital images from medical imaging devices (modalities) over a
10/100Base-T or 1000Base-T Ethernet Network.

5–2 AD3435_en | 2016-03-31


Publication History

Revision Date Reason for Change

A 2016-03-31 First release

B 2016-03-31 Deleted a reference to a machine number.

AD3435_en | 2016-03-31 I
KONICA MINOLTA, INC.
1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan
© KONICA MINOLTA, INC., 2016
Made in the USA.
KONICA MINOLTA and DRYPRO are trademarks of KONICA MINOLTA, INC.
Pub. No. AD3435_en
Rev. B
Pre-Installation Manual
Use this checklist to prepare to install the imager. Review and complete these requirements.
• After you receive the imager, review the Safety Manual before starting the installation.
• When finished, return the signed Pre-Installation Manual to your Service Provider.
If you have questions, contact your Sales Representative or qualified Service Provider.

Power Requirements
Ready? A power cord is provided with this equipment. All countries must use an agency-approved power
cord with a plug type suitable for the country of use. Connect the equipment to a power source
that is suitable for the voltage and current ratings at your site:
• Input voltage = 90–132 V (ac), 50/60 Hz ± 3 Hz
• Input voltage = 180–264 V (ac), 50/60 Hz ± 3 Hz
The single-phase power source, with grounding, must be provided within 2.5 m (8.0 ft) of the
imager.
The wire must be insulation-rated for input voltage = 600 V (ac). A dedicated line is recommended.

Network Requirements
Ready? The imager receives digital images from medical imaging devices (modalities) over a 10/100Base-T
or 1000Base-T Ethernet Network.
During the installation, the Service Provider will enter the network information for the imager to
let it communicate across the network.
Gather and record the information in the following table prior to the installation. See your site’s
network administrator for help to gather the information. Have this page available when you start
the installation.
Required Information for the Laser Imager: Complete the table:
Host (Computer) Name
IP Address—Use the format: xxx.xxx.xxx.xxx
Subnet Mask—Use the format: xxx.xxx.xxx.xxx
Default Gateway—Use the format: xxx.xxx.xxx.xxx
DICOM Port Number—The default port number, 5040,
is correct for most installations. If necessary, you can
change it for your site. You will enter the port number
in two places: at the modality and at the imager.

Pub No. AD3440_en 2016-03-31


Location Requirements
Ready? • Allow 31 cm (12 in.) clearance around the top, sides, and back of the imager.
• The table or counter must be level (within 1°) and capable of supporting the imager’s weight.
• The recommended table or counter height is 71–76 cm (28–30 in.).
• Place the imager in an area with good ventilation. A small, confined room is not recommended.
• Avoid placing the imager in direct or excessive sunlight (for example, near a large window), or
in an environment with dust, dirt, or airborne chemicals.
• Recommended temperature: mid-range within the operating environment: 15–33 °C (59–91 °F).
• Recommended relative humidity: mid-range within the operating environment: 20–80 % RH,
non condensing.

Unpacked Packed Unpacked Packed


Height 66.6 cm (26.2 in.) 98.0 cm (38.6 in.) Depth 64.9 cm (25.5 in.) 83.9 cm (32.7 in.)
Width 62.6 cm (24.6 in.) 85.0 cm (33.5 in.) Weight 79 kg (175 lb) 98 kg (215 lb)

NOTE: The approximate weight of a 35 x 43 cm (14 x 17 in.) film cartridge is 3.5 kg (7.7 lb).

Film
Ready? Prior to installation, you must order and have available the appropriate film. The imager prints on
KONICA MINOLTA Medical Imaging Film in the following sizes:
• 20 x 25 cm (8 x 10 in.)
• 25 x 30 cm (10 x 12 in.)
• 28 x 35 cm (11 x 14 in.)
• 35 x 43 cm (14 x 17 in.)
Blue and mammography film types are supported. Contact your Sales Representative with
questions or for help ordering film.

Ready to start the installation?


Once you have completed and recorded the items in this checklist, please sign and return this form to your
qualified Service Provider.

Your Signature:

Date:

Pub No. AD3440_en, Rev. A Publication History: KONICA MINOLTA, INC.


© KONICA MINOLTA, INC., 2016 Rev A: 2016-03-31, First release 1 Sakura-machi, Hino-shi,
Tokyo, 191-8511, Japan
KONICA MINOLTA and DRYPRO are
trademarks of KONICA MINOLTA, INC.
Made in the USA.
Safety Manual

Publication No. AD3436_en


2016-03-31
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.
Contents

Safety and Related Information


Safety, Warnings, and Cautions....................................................................................................... 1
Safety Labels ............................................................................................................................... 4
System Labels .............................................................................................................................. 5
Safety and Health Compliance ........................................................................................................ 8
Safety Standards ......................................................................................................................... 8
EMC Standards............................................................................................................................ 9
EU Directives ............................................................................................................................. 14
CE Marking................................................................................................................................ 14

Publication History

AD3436_en | 2016-03-31 i
Safety and Related Information
The information contained herein is based on the experience and knowledge relating to
the subject matter gained by the manufacturer prior to publication.
No patent license is granted by this information.
The manufacturer reserves the right to change this information without notice and
makes no warranty, express or implied, with respect to this information. The
manufacturer 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 the manufacturer’s negligence or other fault.
For product specifications, see the Operation Manual.

Safety, Warnings, and Cautions


Please read and understand all instructions before using this product.

DANGER
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 attempt to service or repair the laser imager
yourself to avoid exposure to dangerous voltage, laser beam, or other danger. Always call an
authorized service provider 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.
• A power cord is provided with this equipment. All countries must use an agency-approved
power cord with plug type suitable for the country of use. Contact a qualified dealer for help.
• Do not operate equipment with the covers open.

DANGER
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.

AD3436_en | 2016-03-31 1
Safety, Warnings, and Cautions

DANGER
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
The operator must not touch or have contact simultaneously with the patient and the laser
imaging system.

Caution
Do not use a cell phone within 2.0 m (6.6 ft) of a laser imager. This proximity includes any imager
behind a wall adjacent to your location.

Caution
Do not use a microwave oven within 4.0 m (13.1 ft) 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.

Caution
This equipment uses a DICOM network port, and is intended to connect to other medical devices
over the network. It is not intended to be connected directly to other medical devices. Only
qualified personnel may provide installation and service.

Caution
This device should not be used in close contact with MRI devices, due to possible very high
magnetic fields near an MRI unit. The magnetic field in the area where this equipment is installed
must be less than 50 G.

Caution
Do not substitute or modify any part of this equipment.

2 AD3436_en | 2016-03-31
Safety, Warnings, and Cautions

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 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 and other User Documentation, 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.
This device complies with 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.

Caution
Changes or modifications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.

Caution
Do not use isopropyl alcohol to clean the exterior surfaces of the laser imager.

Caution
In the U.S., exhausted filters are considered to be non-hazardous waste according to the US
Environmental Protection Agency Resource Conservation Recovery Act (RCRA). Municipality
owned and licensed solid waste management facilities are an appropriate disposal option.
Contact your local or state solid waste authorities to determine if additional disposal requirements
apply. In other regions, contact local or regional solid waste authorities for proper disposal
guidance.

Caution
Lithium batteries should only be replaced by an authorized service provider. 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. The U.S. 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. In other regions, contact local or regional solid waste authorities for proper disposal
guidance.

Laser Warning
The equipment uses an invisible laser beam with a maximum power of 120 milliwatts. 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. USE OF CONTROLS OR
ADJUSTMENTS, OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN,
MAY RESULT IN EYE DAMAGE.

AD3436_en | 2016-03-31 3
Safety, Warnings, and Cautions

Important
Install the printing system in a secure location to protect patient privacy rights if required by local
regulations.

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

English Text on Labels


Some names on the labels are shortened and left in English. Below is a key to understand
the meanings of the shortened words on the labels:
Symbol on label Definition

Model Number

Serial Number

CAT Number

Part Number

Manufactured Date

Manufactured By

Operator must read the user documentation

Consult instructions for use

4 AD3436_en | 2016-03-31
Safety, Warnings, and Cautions

Symbol on label Definition

Attention! Consult accompanying documents

Protective earth (ground)

System Labels

Laser Radiation Warning

1 Class 3B invisible laser radiation. This label states: “When open and interlocks
defeated, avoid exposure to the beam.”

2 Hazard symbol

Table 1: Laser specifications

Type Scanning (moving) laser beam emitting from a diode

Wavelength 810 ±10 nanometers

Maximum power 120 mW

Beam divergence from Minimum: 5 °, maximum: 32 °


Laser Diode

High Voltage Warning

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.

AD3436_en | 2016-03-31 5
Safety, Warnings, and Cautions

Back Panel and Agency Statements

Figure 1: Laser Imager Back Panel

Item Label Description

1 FCC compliance Describes compliance, if applicable for the country of installa-


tion.

2 Serial plate Shows the serial number and model number of the imager
along with other important data items.

3 Product States that the imager is a Laser Imaging Printer.

6 AD3436_en | 2016-03-31
Safety, Warnings, and Cautions

Item Label Description

Agency labels and • High voltage. Indicates that high voltage is present
Class 1 Laser Safety under panels where the label is attached. Only an autho-
rized service provider should attempt access.
• Static Sensitive Equipment. Identifies static-sensitive
components. Connect a personal grounding strap to the
appropriate ground before servicing this laser imager.
These panels may only be removed by an authorized
service provider.
• Radio Frequency Energy. 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.
• Class 1 Laser. Indicates that the laser imager complies
with IEC requirements for Class 1 Laser systems.

Grounding reliability States that grounding reliability can only be achieved when
the equipment is connected to an equivalent receptacle
marked “Hospital Only” or “Hospital Grade.”

Safety sign Indicates that the operator must read the user documenta-
ISO 7010–M002 tion.

4 Japanese import Allows importation into Japan.


license

5 Power cord inlet Covers the power cord inlet when shipped from manufactur-
ing. Shows the voltage at which the laser imager must be
operated. The label is removed or moved during installation.

Hot Surface

Figure 2: Hot Surface Labels

This label indicates that you must use care where the label is installed to avoid possible
burns.

AD3436_en | 2016-03-31 7
Safety and Health Compliance

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.

Safety Standards

United States
• 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
• ANSI/AAMI ES60601-1 (2005+C1+A2)
• UL 60601-1 Ed. 1 (2006): Medical electrical equipment - Part 1: General requirements
for safety.
• IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification,
requirements and user’s guide.

Canada
• CAN/CSA - C22.2 NO 60601-1 (2008): Medical electrical equipment - Part 1: General
requirements for safety.
• IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification,
requirements and user’s guide.
• CAN/CSA - C22.2 NO 601.1 (2005): Medical electrical equipment.

Europe
• EN 60601-1 Ed. 3 (2006): Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
• EN60825-1 (2005+Corr:07): Safety of laser products - Part 1: Equipment classification,
requirements and user's guide.

International
• IEC 60601-1 Ed. 2 (1988) - Medical electrical equipment - Part 1: General requirements
for safety.
• IEC 60601-1 Ed. 3 (2005): Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
• IEC 60825-1 (2005+Corr:07): Safety of laser products - Part 1: Equipment classification,
requirements and user's guide.

8 AD3436_en | 2016-03-31
Safety and Health Compliance

EMC Standards

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 commercial or
light industrial installation.
• RF Exposure Guidance: This equipment complies with FCC radiation exposure limits
set forth for an uncontrolled environment. This transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter, except in accordance
with FCC multi-transmitter product procedures.

Canada
• CAN/CSA-C22.2 NO. 60601-1-2-08 Medical Electric Equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements and Tests.
• 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
EN60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and Tests.

Rest of World
IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and Tests.

AD3436_en | 2016-03-31 9
Safety and Health Compliance

Guidance and Manufacturer’s Declaration for Electromagnetic Emissions

The equipment is intended for use in the electromagnetic environment specified below.
The customer or user of the equipment should ensure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic Environment—Guidance

RF emissions: Group 1 The equipment uses RF energy only for its internal func-
• EN 55011 tion. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
• CISPR 11 equipment.

RF emissions: Class A The equipment is suitable for use in all establishments


• EN 55011 other than domestic and those directly connected to the
public low-voltage power supply network that supplies
• CISPR 11 buildings used for domestic purposes.

Harmonics emissions: Class A


• EN 61000-3-2
• IEC 61000-3-2 The equipment is suitable for use everywhere, including
those establishments directly connected to the public
Voltage fluctuations and Complies low-voltage power supply network that supplies build-
flicker emissions: ings used for domestic purposes.
• EN 61000-3-3
• IEC 61000-3-3

10 AD3436_en | 2016-03-31
Safety and Health Compliance

Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

The system is intended for use in the electromagnetic environment specified below. The
customer or user of the laser imager should ensure that it is used in such an environment.
Electromagnetic Environ-
Immunity Test IEC 60601 Test Level Compliance Level ment— Guidance

Electrostatic dis- ±6 kV contact ±6 kV contact Floors should be wood, con-


charge (ESD): ±8 kV air ±8 kV air crete, or ceramic tile. If floors
• EN 61000-4-2 are covered with synthetic
material, the relative humid-
• IEC 61000-4-2 ity should be at least 30 %.

Electrical fast tran- ±2 kV for power supply ±2 kV for power sup- Mains power quality should
sient/burst: lines ply lines be that of a typical commer-
• EN 61000-4-4 ±1 kV for input/output ±1 kV for input/out- cial or hospital environment.
lines put lines
• IEC 61000-4-4

Surge: ±1 kV differential mode ±1 kV differential Mains power quality should


• EN 61000-4-5 ±2 kV common mode mode be that of a typical commer-
±2 kV common cial or hospital environment.
• IEC 61000-4-5
mode

Voltage dips, short <5 % UT*(> 95 % dip in < 5 % UT (> 95 % Mains power quality should
interruptions and UT) for 0.5 cycle dip in UT) for 0.5 be that of a typical commer-
voltage variations on 40 % UT (60 % dip in cycle cial or hospital environment.
power supply lines: UT) for 5 cycles 40 % UT (60 % dip If the user of the laser imager
• EN 61000-4-11 in UT) for 5 cycles requires continued operation
70 % UT (30 % dip in
70 % UT (30 % dip during power mains interrup-
• IEC 61000-4-11 UT) for 25 cycles
in UT) for 25 cycles tions, it is recommended that
< 5 % UT (> 95 % dip in the laser imager be powered
UT) for 5 sec. < 5 % UT (> 95 %
from an uninterruptible
dip in UT) for 5 sec.
power supply or a battery.

Power frequency 3 A/m 3 A/m Mains power quality should


(50/60 Hz) magnetic be that of a typical commer-
field: cial or hospital environment.
• EN 61000-4-8
• IEC 61000-4-8

* UT is the AC mains voltage prior to application of the test level

AD3436_en | 2016-03-31 11
Safety and Health Compliance

Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

The equipment is intended for use in the electromagnetic environment specified below.
The customer or user of the laser imager should ensure that it is used in such an
environment.
Portable and mobile RF communications equipment should be used no closer to any part
of the system, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Compliance
Immunity Test IEC 60601 Test Level Level Electromagnetic Environment—Guidance

Conducted RF 3 Vrms 3 Vrms d = 1.17 √ P


IEC 61000-4-6 150 kHz–80 MHz

Radiated RF 3 v/m 3 v/m d = 1.17 √ P 80 MHz to 800 MHz


IEC 61000-4-3 80 MHz–2.5 GHz d = 2.33 √ P 800 MHz to 2.5 GHz
Where d is the recommended separation
distance in meters (m) and
P is the maximum output rating of the
transmitter in watts (W) according to the
transmitter manufacturer.
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey*, should be less than the compliance
level in each frequency range†.
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:

Note
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.

* Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios, ama-
teur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electro-
magnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the laser imager is used exceeds the applicable RF compliance level above, the laser imager
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the laser imager.
† Over the frequency range 150 kHz–80 MHz, field strengths should be less than 3 v/m.

12 AD3436_en | 2016-03-31
Safety and Health Compliance

Recommended Separation Distance Between Portable and Mobile RF


Communications Equipment and the System

The equipment is intended for use in an electromagnetic environment in which radiated


RF disturbances are controlled. The customer or the user of the equipment can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communication equipment (transmitters) and the equipment as
recommended below, according to the maximum output of the communications
equipment.
Rated Maximum Output
Power of Transmitter (P) Separation Distance (d) According to Frequency of Transmitter

Watts Meters

150 kHz–80 MHz 80 MHz–800 MHz 800 MHz–2.5 GHz


d = 1.17 √ P d = 1.17 √ P d = 2.33 √ P

0.01 0.12 0.12 0.24

0.10 0.37 0.37 0.74

1.00 1.17 1.17 2.33

10.00 3.70 3.70 7.37

100.00 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended separation dis-
tance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmit-
ter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.

Note
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.

AD3436_en | 2016-03-31 13
Safety and Health Compliance

EU Directives
• 93/42/EEC Title: Council Directive Concerning Medical Devices.
• 1999/5/CE Title: Council Directive Concerning Radio Equipment and
Telecommunications Terminal Equipment.

Figure 3: Recycling Label

In the European Union, this symbol indicates that when the last user wishes to discard
this product, it must be sent to the appropriate facilities for recovery and recycling.
Contact your local authorized representative for additional information.

CE Marking
Documents concerning the conformance of this product to Council Directive 93/42/EEC of
14 June 1993 concerning Medical Devices can be obtained from the Konica Minolta
Representative at:

Konica Minolta Medical & Graphic Imaging Europe B.V.


Hoogoorddreef 9,
1101 BA Amsterdam,
The Netherlands
TEL. +31-20-658-4100

14 AD3436_en | 2016-03-31
Publication History

Revision Date Reason for Change

A 2016-03-31 First release

AD3436_en | 2016-03-31 15
KONICA MINOLTA, INC.
1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan
© KONICA MINOLTA, INC., 2016
Made in the USA.
KONICA MINOLTA and DRYPRO are trademarks of KONICA MINOLTA, INC.
Pub. No. AD3436_en
Rev. A

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