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Chrome M User Manual
Chrome M User Manual
Contents
Copyright and Proprietary Notice................................................................................................ 5
iCRco Warranty.............................................................................................................................. 7
Revision History............................................................................................................................ 11
Chapter 8: Troubleshooting.................................................................................. 61
Contact and Product Information....................................................................................................................... 61
Troubleshooting...................................................................................................................................................61
Technical Support............................................................................................................................................... 62
Copyright
Copyright© iCRco Inc. 2003-2015. All rights reserved.
Trademark
iCR 1000™, iCR 1000 Dual™, iCR 2600™, iCR 2600 Dual™, iCR 2600SF™, iCR Vet™, iCR Vet Dual™, iCR
Mobile™, iCR 1-D™, iCR Chiro™, iCR Chiro Dual™, iCR 3600™, iCR 3600SF™, iCR 3600+™, iCR 3600M™, iCR
VERTX™, iDR™, Fusion DCR™, Chrome™, Chrome Duo™, ChromeM™, Chrome+™, ChromeNDT™, Air DR™,
Air DRc™, Fusion DR Mobile™, QPC XSCAN32™, Captera™, XC™, iSCAN™, and www.icrco.com are the
trademarks of iCRco. All other trademarks are the property of their respective owners, and are hereby acknowledged.
Terms
Any one of the following iCR products will be referred to as "CR unit" throughout this document: iCR Vet™, iCR Vet
Dual™, iCR Mobile™, iCR 1-D™, iCR Chiro™, iCR Chiro Dual™, iCR 3600™, iCR 3600SF™, iCR 3600M™, iCR
3600+™, iCR VERTX™, iCR Fusion™, Chrome™, ChromeM™, Chrome+™, ChromeNDT™, and Chrome Duo™.
Any one of the following iCR products will be referred to as "DR unit" throughout this document: Air DR™, Air
DRc™, and Fusion DR Mobile™.
Any one of the following iCR products will be referred to as "iCR desktop unit" throughout this document: iCR
VERTX™. The iDR-17™, iDR-34™ and iDR-51™ will be referred to as the "iDR unit" throughout this document.
1
iCRco ChromeM Description
Purpose
The ChromeM unit is an ultra-high resolution Computed Radiography based Mammography System. It is designed to
scan cassettes containing standard or needle phosphor screens (CR plates) using patented technology. CR plates are
transported past a scanning head without bending or using rollers. This flat scan path results in ultra-high resolution
images with high fidelity across the entire image. High resolution is achieved from the CR plates by coupling the flat
scan path with a high-energy laser.
The Chrome unit collects 16 Bit data that is converted to a DICOM 3.0 image and can be stored, viewed,
manipulated, and sent to any other storage device, printer, or viewing station through DICOM. This document
contains a basic technical overview of the CR unit including the optical systems, electronic components, and driving
software subsystems. A general description of the systems functionality and user interfaces will be described.
Unpacking of the hardware is covered, as is software installation and troubleshooting. Intended Users of this manual
include Technologists, Staff Technologists and Physicians who have been properly certified in the usage, and
maintenance of this equipment.
Physical Description
System Specifications
Deliverable Parts
The sales order completely determines what gets delivered with the ChromeM, and how many of each item. The
choices made from the options table below customize the Computed Radiography ChromeM Mammography System.
Deliverables: ChromeM, Optional Accessories, Optional Cassettes, and Optional Computer
The packing list can be found in the pouch on the outside of the box.
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Intended Use
Intended Use
The ChromeM is indicated for use in generating diagnostic medical x-rays images of human anatomy. It is intended
to replace radiographic film/ screen systems in all general - purpose and mammography diagnostic radiographic
procedures.
Read:Read and understand the operating and setup instructions before applying power to the unit.
CONVENTIONS
Danger: A DANGER indicates an imminently hazardous situation which, if not avoided, will result in death
or serious injury. This signal word is to be limited to the most extreme situations.
Warning: A WARNING indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
Caution: A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor
or moderate injury. It may also be used to alert against unsafe practices.
Note: A NOTE indicates important information that helps you make better use of your CR Unit and
Software.
Important: A IMPORTANT indicates either potential damage to hardware or loss of data and tells you how
to avoid the problem.
Read:
A READ indicates that this material must be read before operating.
Equipment Disposal:
An EQUIPMENT DISPOSAL indicates that equipment disposal at end of life to be performed in accordance with
local regulatory requirements. This product is in compliance with the Directive 2011/65/EU on the restriction of
the use of certain hazardous substances (RoHS), with the following exception for lead in shielding for ionizing
radiation equipment utilizing or detecting ionizing radiation, specific to medical devices and monitoring and control
instruments is exempted from the restriction in the Directive 2011/65/EU Article 4 (1) according to ANNEX IV.
Laser Safety
Caution: This equipment employs a Laser radiation may be present if the CR Unit is operated without the
covers. Avoid the laser beam. Direct exposure to laser light must be avoided.
The CR Unit incorporates a Red (greater than equal to 80mw) high-power solid-state laser diode. The CR Unit covers
protect the service person from direct exposure to laser light. These covers will protect a user/service person only
if they are properly installed. Covers must be removed and replaced by properly trained service personnel. Contact
iCRco if there are any issues with the covers being damaged or replacement covers are needed.
Electrical Hazards
Warning: This equipment is operated with hazardous voltages which can shock, burn, or cause death.
Warning: Installation shall be performed in accordance with EN / IEC requirements. No modifications shall
be made to installation or equipment.
Important: The CR Unit must be connected to a uninterruptible power supply (UPS). Failure to use a (UPS)
will void the warranty.
Warning: Extension cords and additional multiple socket-outlets shall not be connected to the 3600 system.
Warning: Connect only items that have been specified as part of the ME SYSTEM or that have been
specified as being compatible with the ME SYSTEM
The equipment must be serviced by properly trained technicians certified by iCRco, Inc. Do not connect the CR Unit
with a damaged or sub-standard power cable. Do not use an extension cord with this device. The CR Unit should
be properly grounded and power connections inspected to ensure safe operation. Use at least a 1300VA (780W)
uninterruptible power supply (UPS) with this device, as it is sensitive to variations in power.
Non-Applicable Functionality
This unit is not responsible for the compression of breast, does not control x-ray exposure, and does not come into
contact with the patient.
iCRco offers and encourages applications and device training prior to use of this unit.
Malfunctioning Equipment
If any iCRco product shows signs of malfunction, discontinue the use of the product immediately and contact
Technical Support at 310-921-9559.
FCC Notification
This equipment generates, uses, and can radiate radio frequency energy, and if not installed properly, can cause
interference with radio communications.
1
Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones, land mobile
radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location where the unit is used exceeds the applicable RF compliance levels above,
the unit should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the unit.
following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflections from structures, objects, and people.
Use Layout
Numerous floor plans for x-ray rooms are possible. The ChromeM can be in the same room as the x-ray source, but a
minimum of five feet away, or in a separate room. Both options are shown below.
2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
3
Operating Information
Voltage Requirements
The ChromeM unit incorporates an international switching power supply. iCRco employs CE-certified, medical-grade
power supplies to allow the unit to work between 100 to 220V AC 50/60Hz. In order to run the ChromeM unit with
different power types, apply voltage to the power input module at the back of the unit. For international units, a local
power cord must be used that can handle the power requirements of the unit. A 13A/125V power cord is sufficient.
Environmental
Environmental conditions for use, transport and storage of ChromeM equipment
The ChromeM unit should not be placed in a room with a film processor present. This will void the warranty.
The humidity and temperature operating limits are 15 to 95% non-condensing, and 50°F to 95°F (10°C to 35°C ),
respectively.
Installation of the ChromeM unit near strong magnetic fields may cause the ChromeM unit to malfunction. The
ChromeM unit should not be placed in a room with an MRI, CT, X-ray source, or any other equipment that produces
strong magnetic fields.
Another factor to consider prior to installing the ChromeM unit is dust and particulates in the environment. The
ChromeM unit is designed to be resistant to dust and particulates that may be present at the installation site. The room
should have good ventilation.
Connectivity
The ChromeM unit should not be used with an extension cord or multiple socket outlet. Plug the ChromeM to at least
a 1300VA (780W) uninterruptible power supply (UPS). The UPS plugs into the wall power.
Notice:
Using ChromeM without a UPS could result in poor image quality and/or damage to the unit.
A network connection is required for technical support. Alternatively, the user must have a phone/fax line that can be
connected to the PC as a minimum to comply with iCRco warranty terms.
Power Switch
The power switch is located on the back side of the unit.
Toggle the power switch to turn the unit ON or OFF.
Physical Requirements
The ChromeM unit requires a stable operating environment. It is important that the ChromeM unit be placed on top of
a flat, well-supported structure.
The ChromeM requires a space that is 32 inches (long) by 15 inches (wide) by 7.5 inches (tall). While the actual
length of the ChromeM device is 25 inches, the extra distance is required in order to properly insert a cassette.
4
Hardware Setup
Unpacking Instructions
1. Find the packing list in the pouch on the outside of the box.
2. Open the box from the top.
Caution:
Always practice proper heavy lifting procedures. Failure to practice proper lifting procedures may result in
injury or damage to the unit.
5. Store the box and any foam inserts somewhere safe & dry, so that if the unit needs to be stored or shipped again,
there are packing materials available.
Notice: The ChromeM plugs into at least a 1300VA (780W) uninterruptible power supply (UPS). Using
Chrome without a UPS could result in poor image quality and/or damage to the unit.
1. Plug the power cable for the unit into the power switch unit.
2. Plug the other end of the power switch cord into the battery back-up side of the UPS.
3. Make sure the UPS is not in bypass mode.
4. Plug the UPS into a standard wall outlet.
International Power Cable
The unit utilizes an international IEC-grade connector for the power cable and systems are shipped with a standard
NEMA 6 cable. The cable needs to be changed depending on the male end, which varies from country to country.
5
Software Setup
XC System Recommendations
Minimum Hardware
• Intel Core i3 CPU or greater
• 4 GB RAM or greater
• 7200 RPM Disk with >250GB
Software Recommendations
Genuine Microsoft Windows Operating System:
• Windows 7 (64-bit) with Microsoft .Net 4.x and Java version 1.6
• Windows 8.1 (64-bit) with Microsoft .Net 4.5.1 or higher and Java version 1.6
Installing XC
If a personal computer is purchased from iCRco the XC software will already be installed. For DOD licensing the
software includes an enterprise software license and shall not require an external device, a dongle key nor soft key to
operate the system. These instructions describe how to install XC if you have your own workstation. USB drivers for
iCRco hardware are installed automatically with the installation of XC.
1. Insert the media containing the XC installer in the computer. The software key (dongle) is found in the accessories
box. Plug it into an open USB port on the workstation.
Initial Configuration
The first time the XC application is run you will be prompted to use the old or new image processing settings.
Answering "Yes" at the prompt will keep the old settings. A "No" answer loads new image processing settings.
Field Value
Target Name What you want to call it
Target AET Title Applications Entity Title of the target application
IP Address The IP Address of the target application
TCP Port The DICOM receive port of the target application. 104
is the default port.
Modality The DICOM tag the sending images should be
identified as.
Target Type The annotation type the sending images contains.
Graphics Object is the newest, followed by Overlay,
then Embed. If you can't see annotations at the target
application, change this setting.
For Processing Enable if the target application is going to do image
processing. For example, a dedicated Mammographic
CAD application. This sends the image from XC
without processing it.
XScan QPC Enable only if sending to the QPC XSCAN32
application.
5. Select the Finish button.
6. Click the Close and Accept button to confirm the changes.
When the Accept and Send button is clicked at the Image widow, the image will send to the specified targets.
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Operating Instructions
Power Up
1. Make sure the power cord is properly inserted into the power module.
2. Make sure the power cord is properly inserted into the battery back-up side of the UPS and the UPS is plugged
into a standard wall outlet.
Warning: Extension cords and additional multiple socket-outlets shall not be connected to the system.
3. Make sure the USB 2.0 cord is properly inserted into the unit and computer.
4. Power ON the computer.
5. Power ON the unit
Warning:
Do not remove machine covers or operate machine with covers removed. Equipment maintenance and
repairs to be performed by authorized personnel only.
Cassette Handling
Overview
Unlike other solutions, the unit protects the delicate phosphore imaging plate from damage through outside contact.
The hard x-ray cassette is designed to protect the plate and allows for it to be read by the unit. The delicate imaging
plate is embedded within a rigid cassette in such a way that nothing touches the plate during the scanning or handling
process.
Cassette Storage
All cassettes should be stored in the cleanest, driest location and protected from radiation exposure. Always store
cassettes in an area where they are not likely to be knocked over or damaged. With careful handling, the cassette plate
system should provide years of service as there is no known lifetime for the phosphors used in the plate system.
Cassette Contamination
Should the situation arise where a cassette may come in contact with bodily fluids or other contaminated materials,
place the cassette in a clean plastic bag or envelope before exposing the x-ray. This will ensure that the cassette stays
clean and usable. Make sure that the plastic is not wrinkled to avoid the creases showing in the image.
Image Fading
An exposed cassette will lose image quality if the scan unit door is left open or if the phosphor plate is exposed to
ambient lighting after irradiation. This can be avoided by ensuring the scan unit door is shut during the scanning
process and by carefully handling the cassette so that the cassette door does not open between irradiation and
scanning.
Note:
The cassette door naturally locks into place, preventing it from easily opening when not in use.
Note:
The cassette image normally decays with a 6.18 percent loss within 8 minutes and a 23.75 percent loss within
64 minutes.
Table 6: Recorded Data on Average Pixel Value as a Function of Scanning Time Delay
Image Readout Exposure Time Scan Started Time Delay Average Signal Equivalen
(hh:mm) (hh:mm) (min) (pixel value) Exposure (mR)
1 12:38:00 PM 12:39:00 PM 1 27084 110.763
2 12:44:00 PM 12:46:00 PM 2 26941.75 113.113
3 01:08:00 PM 01:12:00 PM 4 27144.87 109.77
4 01:13:00 PM 01:21:00 PM 8 27515.84 103.935
5 01:31:00 PM 01:47:00 PM 16 28280.47 92.83
6 01:50:00 PM 02:22:00 PM 32 28651.79 87.89
7 02:23:00 PM 03:27:00 PM 64 28920.92 84.458
Cassette Loading
1. Choose an appropriately-sized cassette (18x25cm or 24x30cm).
2. Load the cassette into the center of the CR unit's cassette slot. The logo side of the cassette faces upwards and the
black, carbon side faces downwards.
Caution:
Do not use excessive force when loading the cassette! The cassette will not fit if the orientation is
incorrect.
Notice:
Do not press down on or place objects on the cassette! This could potentially damage the cassette or
prevent its removal.
XC Manual
This section covers only the basic functions of the XC software.
For more detailed information, please read the XC User Manual.
Logging In
1. In the User Login dialog, enter a User name and password.
Note:
Alternatively, the User may select from a drop-down list of previously entered User names by clicking the
drop-down menu on the right-hand side of the User name text field.
2. Click Log In to log in.
The user can log out of XC from the Worklist screen by clicking the Log Out button.
The user can shut down XC from the Worklist screen by clicking the Quit button.
The user can launch the default web browser from the Worklist screen by clicking the Web Browser button.
The user can erase the plate from the Worklist screen by clicking the Condition button.
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Cleaning, Maintenance, Storage, and Disposal
Schedule of Maintenance
The following is a schedule of maintenance for the unit. Do not perform maintenance while using the unit with a
patient.
The following maintenance may be performed by end users:
The following unit maintenance must only be performed by an iCRco authorized service engineer:
The following unit calibration maintenance must only be performed by an iCRco authorized service engineer:
Warning: The selection and description of the appropriate disinfection procedure and policy is the
responsibility of the user. The applicable instructions of the applied disinfecting product must be followed.
Caution: Consult the manufacture's Material Safety Data Sheet before use.
Scan Unit
Important: It is important that the covers remain on the unit at all times. The covers should only be removed
for service by an iCRco authorized technician, then immediately replaced.
To clean the outside covers of the scan unit use a slightly dampened cloth or a dry cloth moistened with detergent,
alcohol, or windex.
To disinfect the scanner's outside covers use Microzid wipes, Sani-Cloth wipes, or Sporicidin wipes.
IP Plate
Note:
If a plate cleaner is not available, please contact Technical Support at +1-310-921-9559 to obtain more.
2. Wipe clean the IP plate using light pressure and follow the Wiping Pattern below. Do not wipe in a circular
pattern.
Note:
If a plate cleaner is not available, please contact Technical Support at +1-310-921-9559 to obtain more.
2. Wipe clean the IP plate using light pressure and follow the IP Plate Wiping Pattern above. Do not wipe in a
circular pattern.
3. Allow the IP Plate to air-dry
4. Lightly wipe the edges of the carbon fiber door clean and allow to air dry.
5. Slide the carbon fiber door back into place on the cassette.
Storage
For storage please place in original packing materials and under the storage conditions specified in System
Specifications, which are repeated in the table below.
Condition Value
Temperature Non-operating: 0 to 150ºF (-18 to 65ºC)
Humidity 15 to 95% non-condensing
Vibration/Acceleration 3-4G Max (in shipping)
Altitude Operating: 0 to 9,500 ft.
Disposal
At end or life of the unit it must be recycled. This is true for its accessories and workstation as well. For recycling
assistance or environmental performance information, please contact iCRco. In the case of dismantling the product,
local regulations regarding hazardous substances must be followed. Precautions should be taken to prevent injury to
personnel and damage to the environment. The symbol below indicates this should not be treated as household waste,
but in accord to the Directive 2011/65/EU on the restriction of the use of certain hazardous substances (RoHS) and
WEEE directive (2002/96/EC) and national law.
Note: Improper handling of this type of waste could have a negative impact on the environment and human
health due to potentially hazardous substances that are generally associated with EEE. By ensuring that this
product is disposed correctly, the user will contribute to the effective use of natural resources.
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Troubleshooting
Contact Information
Troubleshooting
Table 11: General Solutions
Problem Analysis
The CR unit does not run Ensure that the power cable is securely plugged into the CR unit and into the battery-
side of the UPS. Check that the UPS is plugged into a standard wall outlet.
Using an electronic appliance, check to ensure that the wall outlet is outputting power.
If not, plug the UPS into a working outlet.
The system does not Try plugging the software license key (dongle) into a different USB slot on the
recognize the security computer.
dongle
Check the back of the software license key. If there is a green, blinking light, the
software drivers need to be reinstalled or the dongle is damaged.
The CR unit is not Ensure that the USB cable is properly connected to the CR unit and the computer.
communicating with the
Try plugging the USB cable into a different USB slot on the computer.
acquisition software
Restart the CR unit and the software program. Be sure to start the CR unit before
loading the software.
Problem Analysis
There are ghost images or Ensure the cassette is blank before using it.
the image is unclear
Ensure the cassette is placed correctly into the CR unit.
Technical Support
Having trouble? If you need technical assistance call iCRco Technical Support.
Call (866) 907-7740 for assistance.
Your time is important to us. If you take the following steps, we'll better be able to assist you and resolve any
problems you might be facing.
1. Write down your serial numbers. These numbers can be found on the blue iCRco plate on the side of the unit
below the fan.