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iDR USER MANUAL

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1. DR USER MANUAL Digital Imaging Made Simple iDR _ User Manual Foreword Proprietary Notice and Disclaimer The information herein disclosed is the property of tCRco Inc Information in this docu ment is subject to change without notice and does not represent a commitment by iCRco to incorporate changes or improvements in units previously sold or shipped No part of this document may be reproduced or transmitted in any form electronic or mechanical including photocopying and recording for any purpose other than the purchaser s own use without the express written permission of tCRco Copyright Copyright iCRco Inc 2003 2010 All rights reserved Trademarks CR 26000 CR 100060 CR 1000 Dual CR 260068 CR 2600 Dual CR 2600SF CR Vet R CR CR Vet Dual CR Mobile CR 1 D CR Chiro CR Chiro Dual CR 36000 CR 3600SFR CR VERTX 1DR www icrcompany com and QPC XSCAN32 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 the CR unit throughout this document CR 100068 CR 1000 Dual CR 26000 CR 2600 Dual CR 2600SF CR 36000 CR Vet CR Vet Dual CR Mobile CR 1 D CR Chiro CR Chiro Dual CR VERTX Any one of the following CR products will be referred to as
2. ANY USE REPRODUCTION OR DISTRIBUTION OF THE PROGRAM CONSTITUTES RECIPIENT S ACCEPTANCE OF THIS AGREEMENT 1 DEFINITIONS Contribution means 5 Click Next at the Custom Setup screen to continue iz Captera Setup E Custom Setup Select the way you want features to be installed Click the icons in the tree below to change the way features will be installed The necessary files to run Captera E y gt Program Files E Demonstration Images This feature requires 103MB on your hard drive a 6 Click Install to begin the installation ie Captera Setup Ready to install Captera Click Install to begin the installation Click Back to review or change any of your installation settings Click Cancel to exit the wizard Cancel 7 Please be patient while Captera installs Depending on the speed of the computer and available RAM this process could take a few minutes 2007 2009 12 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual ie Captera Setup Installing Captera Please wait while the Setup Wizard installs Captera 8 Click Continue Anyway if prompted by the Windows compatibility wizard iz Captera Setup Software Installation The software you are installing has not passed Windows Logo testing to verify its compatibility with Windows XP Tell me why this testing is import
3. CR dual unit throughout this document CR 1000 Dual CR 2600 Dual CR Vet Dual CR Chiro Dual Any one of the following CR products will be referred to as CR desktop unit throughout this document CR VERTX The iDRQ will be referred to as the DR unit throughout this document 2007 2009 i of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Contact Information CRco Inc Address Phone Fax Email Web CRco Inc Address Phone Email Web USA 2580 West 2374 Street Torrance CA 90505 1 310 921 9559 1 310 542 7236 info icrcompany com http www icrcompany com Europe 31a Ridlerstrasse 80339 Munich Germany 49 89 2555 757 150 info icrcompany com http www icrcompany com DR Information Please Enter the details of the DR system here Serial Number Date Purchased Interface Type USB 2 0 2007 2009 ii of 46 Confidential and Proprietary Property of iCRco Inc Document IDR 01A Rev C July 1 2010 iDR User Manual Safety Information Read and understand the installation and operating instructions before applying power to the iDR Figure 1 iDR Safety Labels INPUT 24VDC 10A CAUTION FOR CONTINUED PROTECTION AGAINST RISK OF FIRE REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE E 10A 125V INPUT 100 240VAC V 3A 50 60Hz CAUT
4. CLARITY CAPTERA Password User OL nee 2007 2009 23 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRYM_ User Manual 6 4 Creating Patients 1 From the Patient List window click the Schedule Patient button 2 Fill in the desired patient information Last Name First Name Referring Physician amp Institution are required fields 3 Click the Finish button to return to the Patient List window or click the Finish And Scan button to begin the process of scanning an image Figure 6 2 Captera s Patient Data Entry Screen Schedule Patient Patient Info Patient ID Y Automatically Generate Patient ID Last Name First Name Patent MP coming Study Info Study ID Accession Institution Study Date CO MO Eau Study Time KIO EMO Ex Referring Physician Cancel 6 5 Editing Patient Information Visit Comments Anatomy Current Anatomy Finish Finish And Scan 1 Locate the desired patient in the Patient List window 2 Click the desired patient s Patient Information Bar 3 In the Study Information window click the Patient Information Bar again 2007 2009 Confidential and Proprietary Property of iCRco Inc 24 of 46 Document IDR 01A Rev C July 1 2010 DRYM_ User Manual Figure 6 3 Click the Patient Information Bar to edit Patient Information Q Name Foote John 10017 DOB 01 January 2010 Sex M
5. The Advanced button reads in the settings from the scanner s EEPROM and allows the User to edit these values Demo Settings Turning on the Enable Demo CR option will allow the User to scan an image without a scanner attached to the computer An image from the demo images library will appear when scanned Turning on the With CR Motor option will also the user to scan in demo mode a with a scanner attached The scanner will then run the motor but will not acquire an image from the plate instead it will use an image from the Demo images library Condition Plate Allows the User to perform a deep erasure of the IP Plate 6 8 3 X ray Tubes The X ray Tubes tab allows the User to specify the model of X ray tubes attached to the system Current options are Sedecal Stationary or Sedecal Portable The COM Port of the attached X ray tubes may also be specified The Exposure Count displays the total number of scans made on the system 6 8 4 Settings Data Representation The bit depth of the DICOM file when it is DICOM sent or exported out of DR Current options are 16 12 10 or 8 bit Look Up Table Type The type of Look Up table that is embeded in the DICOM file when it is DICOM sent or exported out of iDR Current options are Linear or Sigmoid If Sigmoid is selected the DICOM Value of Interested Look Up Table VOI LUT entries are generated and stored in the DICOM header 2007 2009 35 of 46 Document IDR
6. 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 DR is used exceeds the applicable RF compliance levels above the DR should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the iDR Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m CRco Warranty iCRco Inc iCRco values your business and always strives to provide high quality products and services All iCRco products are provided with an initial warranty so the hardware and software are covered from the date of purchase This limited warranty solely applies to new products manufactured by or for iCRco and originally purchased from iCRco or an authorized dealer of iCRco products for your own use In addition an extended warranty is available for most new and recently purchased iCRco products for an additional charge Hardware Limited Warranty iCRco warrants its hardware products to be free of defects in materials and workmanship for a period of one 1 year from the date of original shipment from iCRco subject to the limitations set forth herein If a product proves to be defective in material or workmanship during the warranty period iCRco will at its sole option repair or replace the product with a si
7. 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Cleaning the IP Plate 1 With a finger press the cassette catch located on the bottom rail on the cassette This will release the carbon fiber door from the cassette Cassette ieee Catch ie FES 2 Examine the imaging plate for dust or particulates 3 Using iCRco plate cleaner apply the plate cleaner to a clean lint free cloth _ CR Phosphor Plate Clx If tCRco Plate Cleaner is not available please contact Technical Support at 1 310 921 9559 to obtain more 4 Gently wipe down the imaging plate with the clean lint free cloth 5 Allow the plate to air dry before sliding the carbon fiber door back into place 5 5 iDR Cleaning and Disinfection Procedure If the DR is visually contaminated with blood or body fluids remove the blood and or body fluids then follow Section 5 5 3 prior to use AX CAUTION Consult the manufacture s Material Safety Data Sheet before use 2007 2009 21 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRYM_ User Manual 5 5 1 Disinfection Materials 1 Sporicidin Disinfectant Solution and Spray 5 5 2 Disinfection method to be performed after each patient use 1 Wipe the Carbon Fiber material with Sporicidin Disinfectant Towelettes or Sporicidin Disinfectant Solution and Spray 2 Allow to air
8. 2 5 GHz than the recommended separation RF IEC distance calculated from the 61000 4 3 equation applicable to the frequency of the transmitter Recommended separations distance d 12V P d 1 2v P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m 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 symbol o gt 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 continued on next page 2007 2009 vii of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Table 2 continued Immunity IEC 60601 Test Compliance Electromagnetic Environment Test Level Level Guidance Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy
9. 4 Power Switch Location The power switch for the DR unit is located on the left hand side of the unit near the power plug Switch Figure 2 1 DC Power Plug amp Switch Figure 2 2 AC Power Plug amp Switch 2 5 Power amp Scan Lights The power and scan lights are located on the lower right hand side of the DR When the unit is powered on the ereen light is illuminated While the unit is scanning the yellow light blinks 2 6 Physical requirements The iDR requires a stable operating environment iCRco requires that the iDR be used in the supplied Wall mount or Cart Failure to use the DR in the supplied Wall mount or Cart will void the warranty 2 Systems Specifications 2007 2009 3 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual The DR has a 14x17 inch active capture area and is retrofitable to any existing X ray system Pixels per Line Resolution 3500 High Resolution over 14 inches 356 mm 2048 Normal Resolution over 14 inches 356 mm Scan Rate Scan Rate 60 lines second Grey Scale Resolution 16 bits 65 535 shades of gray Interface USB 2 0 Dimensions 35H x 20W x 6D inches 2007 2009 Confidential and Proprietary Property of iCRco Inc Power Requirements AC Input Domestic 100 to 120V 50 60Hz 3 5A International 220 to 240V 50 60Hz 1 75A DC Input Volts 18 36 VDC Amps 4 5 Amps
10. AN Max Watts 450 Watts Temperature Conditions 15 to 95 F 10 to 35 C operating 1 to 150 F 1 to 65 C non operating Humidity 20 to 80 non condensing Vibration Acceleration 3 4G Max in shipping Altitude 0 to 9 500 ft operating Weight 50 Ibs Document IDR 01A Rev C July 1 2010 DRYM_ User Manual 3 Hardware Installation 3 1 Unpacking Instructions Heavy object Two person lift required 1 Open the box from the top 2 Remove any small accessories loaded into the top of the box 3 With at least two 2 people lift the DR out of the box Always practice proper heavy lifting procedures Failure to practice proper lifting procedures may result in injury or damage to the unit 4 Store the box and any foam inserts somewhere safe amp dry so that if the DR needs to be shipped again there are packing materials available 3 2 Installing Power amp USB 2 0 Cables with Power Cowling Switch Figure 3 1 DC Power Plug amp Switch Figure 3 2 AC Power Plug amp Switch 2007 2009 5 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual The following instructions are for both the AC and DC DR units though only the AC is shown below 1 Thread three 3 zip ties through the metal eyelets 2 Lay the Power and USB 2 0 cord bundle in the Power Cowling ensuring that the thickest part of the cord
11. Advanced DICOM Printer 2 0 2 02 eee eee 39 2007 2009 xiii of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual 1 Introduction 1 1 Overview The DR iCRco s patented integrated Digital Radiography system is a sealed Digital Radiography system that uses a high resolution phosphor to capture high quality images The photostimulated luminescence is collected detected sampled and digitized The image data is then digitally processed according to exam and user specified parameters and displayed on a monitor to confirm patient positioning The image can optionally be printed by a hard copy device such as laser printer or dry printer or transmitted to a workstation optical disk file or other destination The device performs lossless compression of the image data for efficient transmission The Image Reader is cassetteless because the Image Plate is built into the DR The imaging plate is exposed via conventional X ray devices The X ray irradiated IP is stationary and the scan head moves from the exposure position to the reading position and images are read After reading the IP is erased and the scan head is moved to the exposure position again The iDR collects 16 Bit data that is converted to a DICOM 3 0 image and can be stored viewed and manipulated This document contains a basic operational overview of the 7DR including the driving softwa
12. 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 A NOTE indicates important information that helps you make better use of your DR and Software A NOTICE indicates either potential damage to hardware or loss of data and tells you how to avoid the problem Laser Safety A CAUTION This equipment employs a laser Laser radiation may be present if the DR is operated without the covers Avoid the laser beam Direct exposure to laser light must be avoided The DR incorporates a Red gt 80mw high power solid state laser diode The DR 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 2007 2009 iii of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Electrical Hazards AX WARNING This equipment is operated with hazardous voltages which can shock burn or cause death The DR must be connected to a uninterruptible power supply UPS Failure to use a UPS will void the warranty The equipment must be serviced by properly trained technicians certified
13. Last Exam Date 4 March 2010 3 38 PM Study ID 126 Physician Dr Doctor Accession Date 4 March 2010 3 38 PM Body Part Not Selected Physician Dr Doctor Accession Comments Return To Patient List Schedule New Study 4 Edit the desired information 5 Click the Finish button to save the changes and return to the Study Information window 6 6 Editing Study Information 1 Locate the desired patient in the Patient List window 2 Click the desired patient s Patient Information Bar 3 In the Study Information window click the Study Information Bar 2007 2009 25 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRYM_ User Manual Figure 6 4 Click the Study Information Bar to edit study information S Name Foote John 10017 DOB 01 January 2010 Sex M Last Exam Date 4 March 2010 3 38 PM Study ID 126 Physician Dr Doctor Accession Date 4 March 2010 3 38 PM Body Part Not Selected Physician Dr Doctor Accession Comments Return To Patient List Schedule New Study 4 Edit the desired information 5 Click the Finish button to save the changes and return to the Study Information window 6 Image Manipulation Tools All Captera image processing manipulation and annotation tools are selected in the Tools Menu Bar on the left side of the Image Display window 6 7 1 Pan The Pan tool allows the User to move the ima
14. OGRE e eS 11 a2 Instaline USD Divers lt a A AA 11 AS metaline Capers add ia e AA A 11 5 System Operation 15 Jal FOWCRUD ma aa a Oh eE A RA ARA ee 15 DO ACQUITNS ANIMADO ride oa eee ae eke ee Ae a 15 59 ochedule Or Maintenances 66 bb hoe a eh aoe a SEES a 19 Of Permodic Clean e ok pata BS Sie FS So ER BU g 20 5 4 1 Cleaning the Outside of the IDR 00 0 20 ZA Cassette Clean sip Ahh A BONA ae ee ERS RS Oo 20 5 5 DR Cleaning and Disinfection Procedure 0 21 S91 Distitection Materials paar as a A ho 22 5 5 2 Disinfection method to be performed after each patient use 22 So Miebher leverot disimiecHon ses taa A E a 22 2007 2009 xii of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual 6 Captera Software Functions 23 6 Lavnchine Capterd 2 0 a4 sierra Wee Bee Bh bak od 23 6 2 Logging In Administrator Account ooo o 0 23 00 DOLO eee ees 23 04 Creatina Eatuents sa bn A a sr AS 24 69 Editing Patient Information weas abi a Boe He Se a 24 6 6 Editing Study Information soeces oe owe Sa OR ee a eR 25 6 7 Image Manipulation Tools 44 4000 40Ke ee eae RA ed 26 OAL Van tm oa Se Seo A es wee ee ee eee ee 26 Oz ZOOM o amp 2 4 Mee e os ee DG BAe a A 27 67 9 E 2 45 aese 654 AA 27 674 Window Level esters rt 44466 42466 4644626624544 27 6 7 5 Smart Box Window Level 0000 eee
15. Week Yesterday and Today or Today 2007 2009 36 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Imaging Domain Sets the scan interface for Medical general radiography Mammography Veterinary small animal or Equine Launch Applications Interface The Applications Interface allows the User to define custom anatomy projects and specify per anatomy processing levels 6 8 5 Text Annotations The Text Annotations tab allows the User to add a list of terms that can be automatically chosen when making a text annotation on the image To add an annotation click the Add button enter the desired term then click the Finish button To remove a term from the list check the check box next to the desired term then click the Remove button 6 8 6 Defaults The Defaults tab allows the User to predefine the Referring Physician and Institution names so that when the User is scheduling a patient the only action needed is selecting the desired Referring Physician and Institution name instead of having to manually enter the names each time Adding a Referring Physician Institution 1 Navigate to Configuration gt Defaults tab 2 Click the Add button in either the Referring Physician or Institution section 3 Enter the desired name 4 Click the Finish button Removing a Referring Physician Institution 1 Navigate to Configuration gt Defaults tab
16. bundle is positioned at the bottom of the power cowling 3 Pull the zip ties as tight as possible around the cord bundle Gently pull on the cord bundle to ensure it is tightened enough in the Power Cowling Clip off any excess zip tie 4 Plug the power cord for the DR unit into the power switch unit then pass the USB 2 0 cable under the safety catch and plug in the USB 2 0 cord 2007 2009 6 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 5 Fasten the Power Cowling to the Shoulder Extrusion using three 3 6 32 x 3 flathead screws 6 Plug the USB 2 0 cord into the Acquisition computer 7 Ensure the UPS battery is connected to its terminal 8 Plug the other end of the power cord into the UPS 2007 2009 7 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRYM_ User Manual 9 Plug the UPS power cord into the wall 3 3 DR Cart Mount A CAUTION The DR cannot be transported in a vehicle while attached to the cart Re move the iDR from the cart before transporting the DR in a vehicle AX WARNING Do not remove the Spring Mount screw shown below until the DR has been secured in the mount The DR Spring Mount screw 1 Remove nine 9 6 32 x 3 4 flathead screws from the Top Mount End Cap There are five 5 screws on the top and two 2 on either side 2 Ease
17. dry 5 5 3 Higher level of disinfection 1 Unplug form the power source 2 Clean the exterior surface with Sporicidin Disinfectant Towelettes or Sporicidin Disinfectant Solution and Spray 3 The surface shall remain wet for ten minutes 4 Then allow to air dry 2007 2009 22 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 Captera Software Functions 6 1 Launching Captera After the initial installation of Captera a shortcut to the application is placed on the User s desktop To launch Captera simply double E mouse click on the desktop shortcut If the desktop icon is not present ma Captera can be launched by going to Start Programs Captera Captera 6 2 Logging In Administrator Account After running the Installer the User should double click on the Captera short cut on the desktop to open Captera The first User account created is the administrator account The administrator account is able to access the program configuration dialog create new Users grant User privileges and quit the application 6 3 Logging In 1 Inthe User Login dialog enter a User name and password Alternatively the User may select from a drop down list of previously entered User names by clicking the arrow button on the right hand site of the User name text field 2 Click Finish to login Figure 6 1 Captera s User Login Screen
18. of either leg or the vertex and readjust the position of the angle 6 7 16 Cobb Angle The Cobb Angle tool allows the User to draw a Cobb Angle with an angle measurement on the image To use the Cobb Angle tool first select it from the pop up menu on the left hand side of the screen Then click hold and drag out the first line of the Cobb Angle to the desired length and position Release the mouse button when the length and position are sufficient For the second line of the Cobb Angle click hold and drag out the line Release the mouse button when the length and position is sufficient At any time the User may click the end of either line and readjust the position of the angle 2007 2009 30 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 7 17 Heart to Lung Ratio The Heart to Lung Ratio tool allows the User to measure the heart to lung ratio on an image To use the Heart to Lung Ratio tool first select it from the pop up menu on the left hand side of the screen Then click hold and drag out the first line of the i Heart to Lung Ratio to the desired length and position Release the mouse button when the length and position are sufficient For the second line of the Heart to Lung Ratio click hold and drag out the line Release the mouse button when the length and position is sufficient At any time the User may click the end of either line and r
19. product unsuitable physical or operating environment maintenance or repair by anyone other than iCRco or the iCRco authorized dealer that sold the product operation of a product beyond its duty cycle use of the product outside of its specifications the use of supplies parts materials software or interfaces not furnished authorized or recommended by iCRco If the product including any software has been opened tampered with modified or altered in any way without written authorization by iCRco the warranty will no longer apply This warranty applies only to products manufactured by or for iCRco and that can be identified by an iCRco serial number as originally affixed to the product Any modifica tion to the iCRco serial number tag or its attachment to the product shall immediately void the warranty This warranty is non transferable and subsequent owners must contact iCRco to establish if the equipment is eligible for an extended warranty THERE ARE NO WARRANTIES EXPRESS OR IMPLIED WITH RESPECT TO ANY iCRco PRODUCT OTHER THAN AS SPECIFICALLY SET FORTH HEREIN AND iCRco SPECIF ICALLY DISCLAIMS ANY IMPLIED WARRANTIES OR CONDITIONS OF MERCHANT ABILITY FITNESS FOR A PARTICULAR PURPOSE AND SATISFACTORY QUALITY ANY WARRANTIES THAT MAY NOT BE DISCLAIMED UNDER APPLICABLE LAW 2007 2009 x of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual ARE LIMITED I
20. 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Data Conversion Clipping Level The level of noise removed from the data when the 16 bit data is scaled to a lower bit resolution using the Data Representation drop down menu A lower number means more noise will be included when the data is scaled A higher number means that some useful information will be clipped when the data is scaled Only a certified iCRco Applications Specialist should adjust this parameter Language Sets the language of the User interface Current supported languages are Chinese English Hindi Russian and Spanish Default Unit System Sets the units of measurement for the measurement tools Supported units of measurement are Imperial and Metric Maximum Zoom Value Sets the maximum value for the Zoom tool Options are 100 200 or 400 Magnification Box Size 1 1 1 Sets the size of the Magnification tool as a value of total viewable size Options are 7 3 1 or 5 Graphics Acceleration Controls whether the graphics rendering is done by the software or the video card If the User notices problems with the display of the graphics this option should be disabled On Screen Keyboard Toggles Captera s built in on screen keyboard Auto Sort Patients Automatically sorts patients within the selected date range Available date ranges are Within One Year Within One Month Within One
21. 1 1 resolution The user can use the Orientation button to change from landscape to portrait view 2007 2009 42 of 46 Confidential and Proprietary Property of iCRco Inc Document IDR 01A Rev C July 1 2010 iDR User Manual Change margins The margin tab permits the user to specify in En Printers Oveday Templates glish or metric units the size of the borders on Image Fi ee the printed image The top and bottom borders A nee on the page can be adjusted independently of the Portrait 7 Show borders for the left and the right hand side of the f LandScape Lock page Inches C mm Borders Additionally the user has the option to control Left Right Top Bottom the internal margins which define the amount s 000 of space left between individual frames on a Image Spacing page with multiple images Internal margins are a ya e defined as multiples of the print page border C Double Border Spacing Size 2 Custom Spacing 1 00 By default internal margins are the same size as the borders with image margins on the left and right hand side of each frame are equal to the left and right hand borders Margins on the top and bottom of each frame are equal to the top and bottom borders of the printed page If the user intends to cut individual frames out of the printed page it is recommended that internal margins are set to twice that of the page which will give a uniform border size on the individual image segments I
22. 2 Select the desired information to remove by click the checkbox next to the name 2007 2009 37 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual 3 Click the Remove button in the appropriate section Setting a Default Referring Physician or Institution 1 Check the box next to the desired default name 2 Click the Set button The entry will be set as the default selection 6 8 7 Users The Users tab allows an administrative User the right to add manage User names and passwords for accessing the Captera application The Require Login toggles the User Login box functionality If users must authenticate before using Captera turn this feature on If user accounts are not desirable turn this feature off Adding a User Account 1 Open Captera 2 Login with the appropriate User name and password Q Click the Configuration button in the lower left hand corner of the Patient Information window Enter the appropriate password to access the configuration settings Click on the Users tab Click on the Add button The Add User dialog will pop up N OD O11 Ha Enter the desired User name and password the password will need to be entered twice once in the Password text field and again in the Confirm Password text field then click the Finish button 8 If the new User account is to have administrative privledges select the button Allow
23. Access To Configuration Settings 9 The new User account will be created amp ready to use Changing a User s Password 1 Open Captera 2 Login with the appropriate User name and password 3 Click the Configuration button in the lower left hand corner of the Patient Information window 2007 2009 38 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Enter the appropriate password to access the configuration settings Click on the Users tab Select the User account to modify by selecting the desired User account from the list Click the Change Password button The Change Password dialog will pop up oO N A Aa Ha Enter the new password in the Password text field then enter the new password again in the Confirm Password text field amp click the Finish button 9 The User s password will be changed amp ready to use Removing a User Account 1 Open Captera 2 Login with the appropriate User name and password Q Click the Configuration button in the lower left hand corner of the Patient Information window Enter the appropriate password to access the configuration settings Click on the Users tab Select the User account to remove by selecting the desired User account from the list Click the Remove button The Remove User dialog will pop up Confirm the removal of the User account by clicking Yes in the Remov
24. F emissions Class B The DR is suitable for use in all establishments including domestic and those directly to the Harmonic Class B public low voltage pwoer supply network that emissions IEC supplies buildings used for domestic purposes 61000 3 2 Voltage fluctu Complies ations flicker emissions EC 61000 3 3 Table 2 Electromagnetic Immunity Immunity IEC 60601 Test Compliance Electromagnetic Environment Electrostatic 2 4 6 kV 2 4 6 kV Floors should be wood concrete discharge Contact Contact or ceramic tile If floors are ESD IEC covered with synthetic material 61000 4 2 2 4 8 kV 2 4 8 kV the relative humidity should be at air air least 30 Electrical 2 kV for 2 kV for Mains power quality should be fast tran power supply power supply that of a typical commercial or sient burst lines lines hospital environment TEC 61000 4 4 1kV for 1kV for input output input output lines lines continued on next page 2007 2009 v of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Table 2 continued Table 2 continued OO O O Immunity IEC 60601 Test Compliance Electromagnetic Environment Surge IEC 1 kV 1kV Mains power quality should be 61000 4 5 differential differential that of a typical commercial or mode mode hospital environment 2 kV 2 kV common mode common mode
25. Foote Michael 10016 Last Exam Date 22 February 2010 1 29 PM Study ID 123 Name Hande Daniel 10015 Last Exam Date 22 February 2010 12 04 PM Study ID 122 Name Hande Jessica Handei0001 Last Exam Date 22 February 2010 12 01 PM Study ID 121 Name Pelvis Robert 10014 Last Exam Date 22 February 2010 11 51 AM Study ID 118 Name Elbow John 10012 Last Exam Date 22 February 2010 11 49 AM Name Skull Mike Last Exam Date 22 February 2010 11 43 AM DOB 14 June 1915 Physici Doctor DOB 28 February 1967 Physician Dr Doctor DOB 01 January 2010 Physician Dr Doctor DOB 01 January 2010 Physician Dr Doctor DOB 01 January 2010 Physician Dr Doctor DOB 01 January 2010 Physician Dr Doctor DOB 01 January 2010 Physician Dr Doctor Accession Sex F Accession Sex Female Acce Schedule Patient 2 Create a new study by clicking the Schedule New Study button 2007 2009 15 of 46 Confidential and Proprietary Property of iCRco Inc Document IDR 01A Rev C July 1 2010 iDR User Manual amp Name Cheste John Cheste10000 DOB 28 February 1967 x Last Exam Date 22 February 2010 1 49 PM Study ID 124 Physic Dr Doctor Pa i Date 25 August 2009 3 00 PM vow BEF Date 25 August 2009 11 05 AM Body Part Chest Physician Dr Doctor Accession Comments Return To Patient List Patient Info Patient ID Y Autom
26. ION FORCONTINUED PROTECTION AGAINST RISK OF ARE REPLACE ONLY WITH SAME TYPEAND RATING OF FUSE FUSE 3A SLOW BLOW 250V US and International Patents Granted US and International Patents Granted CAUTION TO REDUCE THE RIK OF CAUTION TO REDUCE THE RISK OF ri Maley COVER NO USER SERVICEABLE PARIS La EJEA COVER NO USER SERVICEABLE PARTS US Headquarters European Office INSIDE REFER SERVICING TO QUALIFIED US Headquarters European Office INSIDE REFER SERVICING TO QUALIFIED CRco Inc CRco Europe GmbH SERVICE FERSONNEL iCRco Inc iCRco Europe GmbH SERVICE PERSONNEL 2580 West 237th Street Ridlerstrasse 31a 2580 West 237th Street Ridlerstrasse 31a Torrance CA 90505 80339 Munich A DANGER Torrance CA 90505 80339 Munich A DANGER USA Germany USA Germany 310 921 9559 49 89 2555 757 150 radiation when open 310 921 9559 49 89 2555 757 150 Invisible laser radiation when open AVOID EXPOSURE EDS TO BEAM EDA C bed TO BEAM r a aser product r Class 3b laser product FDA 510K Cleared ee Goes FDA 510K Cleared 0086 IEC 825 1 a DR AC Model Label b DR DC Model Label Conventions 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 A WARNING indicates a potentially hazardous situation which if not avoided could result in death or serious injury A
27. N DURATION TO THE INITIAL WARRANTY PERIOD AND NO WAR RANTIES EXPRESS OR IMPLIED WILL APPLY AFTER THIS PERIOD ALL INFORMA TION SPECIFICATIONS PRICES AND SERVICES ARE SUBJECT TO CHANGE AT ANY TIME WITHOUT NOTICE Limitation of Remedies and Liability Exclusion of Damages The exclusive remedy for any defective product is limited to the repair or replacement of the defective product iCRco shall have a reasonable time after determining that a defective product exists to repair or replace a defective product iCRco s entire liability for any product is limited to the actual purchase price for the product This limitation applies even if iCRco cannot or does not repair or replace any defective product IN NO EVENT WILL iCRco BE LIABLE FOR ANY GENERAL SPECIAL CONSEQUEN TIAL OR INCIDENTAL DAMAGES including but not limited to damages related to the loss of use loss of recorded product the installation of replacement product or any inspection testing or redesign caused by any defect or by the repair or replacement of any product arising from a defect in any product This exclusion of damages applies even if the customer advises iCRco or an iCRco dealer of the possiblity of such damages This limitation of remedies also applies to claims against any suppliers or dealers of tCRco iCRco and its suppliers and dealers limitations of remedies are not cumulative Such suppliers and dealers are intended beneficiaries of this limitation 1CRco
28. Top Mount End Cap 7 Carefully remove the Spring Mount screw 2007 2009 10 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 4 Software Installation 4 1 PC Specifications The minimum requirements for the Acquisition computer are as follows Processor Pentium D RAM 2 GB or more OS Windows XP HDD 250 GB or more 4 2 Installing USB Drivers USB drivers for iCRco hardware are installed automatically with the installation of Captera 4 3 Installing Captera 1 Insert the media containing the Captera installing in the computer 2 Double click Setup exe to begin the installation process 3 Click Next at the Welcome screen ie Captera Setup Welcome to the Captera Setup Wizard The Setup Wizard allows you to change the way Captera features are installed on your computer or to remove it from your computer Click Next to continue or Cancel to exit the Setup Wizard Cancel 4 Check the box next to I accept the terms in the Licence Agreement then click Next to continue 2007 2009 11 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 5 Captera Setup E End User License Agreement Please read the following license agreement carefully Common Public License Version 1 0 THE ACCOMPANYING PROGRAM IS PROVIDED UNDER THE TERMS OF THIS COMMON PUBLIC LICENSE AGREEMENT
29. Voltage lt 5 Ur lt 5 Ur Mains power quality should be dips short gt 95 dipin gt 95 dipin that of a typical commercial or interrup Ur for 0 5 Ur for 0 5 hospital environment If the user tions and cycle cycle of the DR requires continued voltage operation during power mains variations 40 Ur 60 40 Ur 60 interruptions it is recommended on power dipinUz for dip in Ur for that the DR be powered from an supply 5 cycles 5 cycles uninterruptible pwoer supply or a input lines battery IEC 70 Ur 30 70 Ur 30 61000 4 11 dip in Ur for dip in Ur for 25 cycles 25 cycles lt 5 Ur lt 5 Ur gt 95 dip in gt 95 dip in Ur for 5 sec Ur for 5 sec Power Power frequency magnetic fields frequency should be at levels characteristic 50 60Hz of a typical location in a typical magnetic commercial or hospital field IEC environment 61000 4 8 NOTE Ur is the a c mains voltage prior to application of the test level continued on next page 2007 2009 vi of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Table 2 continued Table 2 continued O O O O Immunity IEC 60601 Test Compliance Electromagnetic Environment Conducted 3Vrms 150 kHz Portable and mobile RF RF IEC to 80 MHz communications equipment 61000 4 6 should be used no closer to any 3 V m 80 MHz part of the DR including cables Radiated to
30. alled with a 1500VA 1500W uninterruptible power supply UPS iCRco recommends the APC 1000 specification UPS or equivalent For warranty evaluation and service iCRco requires the customer to provide an Internet connection DSL or Dial up or the minimum of a phone line accessible by an extension cord to the product enabling iCRco technicians to perform remote diagnostics on installed equipment In addition each iCRco product must be installed maintained and operated in accordance with the respective product manual Failure to comply with these requirements will result in a voided warranty claim Requesting Warranty Service For information on obtaining warranty service call iCRco s customer support at 310 921 9559 In order to evaluate a warranty service request iCRco requires the following infor mation the iCRco serial number of the product a detailed description of the problem customer name and contact information product location and operating conditions a copy 2007 2009 ix of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual of the purchase documents and sufficient information and authorization including a liabil ity release as to any loss of data that should always be backed up software or network injury or downtime allowing iCRco technicians remote access to the product Product may not be returned to iCRco without first obtaining a Return Mate
31. and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 7 13 Extended Line The Extended Line tool allows the User to draw a line on the image that extends all the way through the image To use the Extended Line tool first select it from the pop up menu on the left hand side of the screen Then click hold and drag out the line to the desired position Release the mouse button when the line is sufficient A line will be drawn all the way through the image 6 7 14 Measurement The Measurement tool allows the User to draw a line with a linear measurement on the image To use the Measurement tool first select it from the pop up menu on the left hand side of the screen Then click hold and drag out the measurement line to the desired length and position Release the mouse button when the measurement line is sufficient The measurement will appear next to the line 6 7 15 Angle The Angle tool allows the User to draw an angle with the interior measurement on the image To use the Angle tool first select it from the pop up menu on the left hand side of the screen Then click hold and drag out the first leg of the angle to the desired length and position Release the mouse when the first leg is sufficient Click the mouse again at the point where the second leg of the angle should end The second leg of the angle will be drawn and the measurement displayed at the vertex At any time the User may click the end
32. ant Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the software vendor for software that has passed Windows Logo testing Please attach your device to this computer any time after the installation has finished 10 Click Finish to finish the Captera installation 2007 2009 13 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual ie Captera Setup Click the Finish button to exit the Setup Wizard 2007 2009 14 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 5 System Operation 5 1 Power Up The power switch is located on the middle left hand side of the device Ensure the UPS is powered on then toggle the DR s power switch to the ON position amp press the Reset button in the scan interface The DR should be allowed to warm up for 5 minutes prior to use in order to stabilize the system 5 2 Acquiring an Image 1 In the Patient List window open the desired patient s Patient Information Bar This will open the Study Information window C CAPTERA Last Physician o Wooa Ew Banner Name Cheste John Cheste10000 Last Exam Date 22 February 2010 1 49 PM Study ID 124 Name
33. atically Generate Patient ID Last Name First Name Study Info Study ID Accession Referring Physician Institution co Como Study Date CIO ENO E20 Study Time ZG EIS ENG Anatomy Current Anatomy Finish Finish And Scan 4 Select the region of the anatomy by clicking on the appropriate body region then select the anatomy by clicking on the appropriate body part 2007 2009 16 of 46 Confidential and Proprietary Property of iCRco Inc Document IDR 01A Rev C July 1 2010 iDR User Manual Select Anatomy Cheste John Cheste10000 Anatomy 5 Select the appropriate view for the anatomy then select the appropriate laterality e g left or right if necessary If the anatomy selected in the previous step does not require a laterality selection the buttons for laterality will be grayed out and not selectable If this is the case please skip to the next step Scan Cheste John Cheste10000 Chest Views 6 Select the cassette size to begin scanning the cassette 2007 2009 17 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Scan Cheste John Cheste10000 Chest Views Laterality ES CR Control Reset CR Return To Previous Screen 14 x 17 inches 10 x 12 inches 8 x 10 inches Cheste John Chest Lateral Left 24 February 2010 9 25 AM Institution Institution Accession Com
34. ay select whether to erase the currently selected annotation or all annotations on the image To erase a particular annotation first select it then click Erase Selected button from the pop up menu on the left hand side of the screen To erase all annotations click the Erase All button from the pop up menu 6 7 22 Hide Show Annotations The User may hide or show all annotations on the image To hide all annotations first open the pop up menu on the left hand side of the screen Then click the Hide Show Annotations button The annotations will no longer be visible To make the annotations visible again click the Hide Show Annotations button 6 7 23 Crop The Crop tools allows the User to discard unwanted information around the edges of the image usually collimation To use the Crop tool first select it from the pop up menu on the left hand side of the screen A green box will appear around the image Click hold and drag the box to the desired size Click the Confirm Crop button The Crop tool will first copy the image then apply the cropping to the new image thus preserving the original image The cropping will be applied 6 7 24 Frequently Used Tools The bottom section of the Tool Bar is reserved for frequently used tools This gives the User quick access to the tools most used in the workflow 6 8 Configuration The Configuration window contains all of Captera s preference amp User settings Only Users with Ad
35. by iCRco Inc Do not connect the DR with a damaged or sub standard power cable Do not use an extension cord with this device The DR 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 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 Mammography Use The DR is not intended for Mammographic use 2007 2009 iv of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Guidance and Manufacture s declaration Electromagnetic Emis sions amp Immunity Table 1 Electromagnetic Emissions Guidance and manufactures declaration electromagnetic emissions The DR is intended for use in the electromagnetic environment specified below The customer or the user of the DR should assure that it is used in such an environment RF emissions The DR uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment R
36. e User dialog O 0 N Os Aa Ha The User account will be removed 6 8 8 About The About tab provides the User with more information about the Captera software in cluding the software version number and the approximate date of the software warranty expiration 6 8 9 Quit The Quit tab provides a button allowing the User to exit amp close the Captera application 6 9 Advanced DICOM Printer Select images for printing 2007 2009 39 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual In Captera select the images to print in the image icon view then select DICOM Print from the toolbar The Advanced DICOM Printer application will open with the selected images imported into the right hand side Alternatively the user can select the region in the preview window where the user wants the image then select the Import Image button Drag and Drop Images To drag images into the print region hold the left mouse button down on one of the image icons on the right hand side and drag it into the preview window A dragging cursor will appear A as the user drags the image from the image icon window to the preview window If the user is out of the accepted region for dropping a cursor S will appear letting the user know that this is not a correct region to drop the image into Split the preview window into regions To split the preview window the use
37. eadjust the position 6 7 18 Center Point The Center Point tool allows the User to define two points on the image with a third point the center mark To use the Center Point tool first select it from the pop up menu on the left hand side of the screen Click once where the first point should be and once where the second point should be A third point will appear marking the center point on the line At any time the User may select either end point and readjust the position 6 7 19 Units of Measurement The Units of Measurement allow the User to toggle the dis played unit of measurement between inches millimeters and pixels To change the unit of measurement open the pop up menu on the left hand side of the screen Then click the desired unit of measurement The unit of measurement will change to reflect the selection 6 7 20 CR Markers CR Markers allow the User to place an l or l marker on the image to indicate the laterality To use a CR Marker first open its pop up menu from the left hand side of the screen Then click d where the marker should be There are three different sizes of marker The User may toggle through the size by clicking on the marker again At any time the User may click hold and drag to reposition the marker 2007 2009 31 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 7 21 Erasing Annotations The User m
38. eee 27 6 7 6 Rotate Clockwise amp Counter Clockwise 0 o 28 67 7 Flip Vertical Se Horizontal sio rs e a is 28 67 6 IMiormati n Overlay spse sa Seu a A A E ae eS 28 6 7 9 Hide Show Annotations 000 eee eee ee 29 67 NO 102 Pr OCCSSING 2 doo ae Be A E 29 Gf Ad ATOW e ao SS eo oe ee a Cae ES A ee A AAA 29 Of AD Lies ud eae o A SS a e oS 29 67 19 Extended Le a a a e a as a 30 6 7 14 Measurements celo a da e Bee A 30 CAD AMC 35 ba BAS a dal a A Boe eS BS 30 67 16 Cobb Amele 0 01 te arena ss a oa Ss 30 6 7 17 cMeartto Laine Rao seke a a AO AAA 31 67 10 Center Pomel sa ed ir po pd a A 31 6 7 19 Units of Measurement 31 67 20 CR Markers cited ds SE Sod Ad 31 6 21 Brasino anmotatons 243 42 58260 bate ra e 32 6 7 22 Hide Show Annotations 000 eee eee ee 32 O72 ClO 6 oie AAA ee bd A A EEO Be 32 0 124 Frequently Used Toole assa pae a ot E owe ia A 32 6 57 CONMCUTAMON e mud Oy are AA A are A 32 68 DICOM 25 44 2034 o es ad es os eee eee E 33 O62 Device SCLUNGS y ae ee a ee oe Es de 34 Ook ta JUDGES sakes oe eS Se Ee ee AAA 35 GO Se TUNES Bs ed tet ite OEMS ee EES eee hada ad 35 68 5 Text Annotations 020 eee eee ee ee ee ens 37 Ooo Deale ewe Sah be Soe Oe ee Se he BS ee SRS eG 37 GO USCIS suc Gis EA a at oot a eo eS 38 6 00 ABOUT papie Soe GAS a Ewe ee eee et EOS 39 607 QU 23002000 Ys SO ER S a Se Se 39 6 9
39. f it is necessary to maximize the amount of space on the printed page the internal margins can be turned off altogether Saving and Loading Print Layout The Templates tab allows the user to save and load pre defined print layouts There are five user defined layouts Set up the layout on the preview window and then select one of the buttons labeled Click here to save current layout The user will be prompted for a title To save more layouts click on the Save Current Template button here the user can set a file name for the Layout The default save location is C X Scan321 Layout Custom 2007 2009 43 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual image PageLayoui Porters Ovela Templates Soni Click here to save current Click a to Save current layout r o Load Template bom File Fie rara ee A E ei LF z Save Cuieni Template Da me type Fori lapid iei f Adding patient demographics Select the Overlay tab to bring up the patient demographic layout options From here the user can select e Text position includes top left top center top right bottom left bottom center bottom right e Text size includes small medium large e Text color includes white on black black on white Image Page Layout Printers Overlay Templates Text Position Patient Demopraphics Overlay Ed m Ol m Tet Posit
40. ge to different positions on the screen To use the Pan tool first select it from the pop up menu on the left hand side of the screen Then click and drag the image until the desired region is visible 2007 2009 26 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 7 2 Zoom The Zoom tool allows the User to alter the on screen magnifica tion level of the image To use the Zoom tool first select it from the pop up menu on the left hand side of the screen Then move the mouse cursor over the image and move towards the top of the image to increase the zoom level or towards the bottom of the image to decrease the zoom level 6 7 3 Magnify The Magnify tool provides a small window that displays a re gion of the image at increased magnification To use the Magnify tool first select it from the pop up menu on the left hand side of the screen Move the mouse over the desired region of interest then click and hold the mouse button and the region of interest will be magnified While holding the mouse button the User may drag the magnified box to different areas of the image 6 7 4 Window Level The Window Level tool allows the User to adjust the brightness and contrast of the image To use the Window Level tool first select it from the pop up menu on the left hand side of the screen Then move the mouse over the image Moving the mouse vertically whi
41. ides the User with a list of files that have been scheduled to DICOM Send but have not actually been sent yet This is only a list of files the User may not interact with anything on this tab To DICOM Send ensure the computer has the proper network connection and the Auto Send Targets tab has been correctly configured 6 8 2 Device Settings The CR Settings tab allows the User to specify the scanner model attached to the computer system the specification of the spot size for normal and high resolution scans enable demo scans deep erase IP Plates and provides access to the hardware EEPROM dialog For this Device This drop down menu allows the User to select the scanner model Plate Size and Spot Size Each plate size can hold it s own spot size settings for both normal and high resolution scans To set a plate and spot size 1 Select the desired plate size from the Plates sized drop down menu 2 Select the desired spot size for both normal and high resolution using the Spot Size drop down menus 3 Click the Close and Accept button to save the changes CR Settings Only iCRco certified technicians should alter the CR Settings Entering improper values may damage the hardware 2007 2009 34 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual The CR Settings allows the User to view the Exposure Index information System Speed Alpha and Mu values
42. in the bottom left hand corner of the DICOM Printer dialog Please ensure all the printer settings are correct first Patient Demographics for Icons When the cursor is over the icon bank Advanced DICOM Print will display the demo graphics for the image 2007 2009 45 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Images Chest Study 1001 1 01 01 1978 Smith 11 11 2004 12 34 59 Chest APPA 101 Chest AP AP Multiple Icon Pages Advanced DICOM Print has an unlimited number of icons that can be loaded However the PC s memory is a restriction To clear the current page of icons click on Clear Current Page button To clear all the pages of icons and preview window click on Clear All Pages button To move between pages and move to first and last pages click on the arrow buttons 2007 2009 46 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc
43. ion Top Right C C Small UN White on Black OC Medium Large 4 Enable Overlay Black on White T Apply to all The user has the option to apply the current settings to every image in the print view or only in the currently selected image via the Apply to all images button or the Apply to image button By selecting the Enable Overlay check box the user can turn patient demographics overlay 2007 2009 44 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRM_ User Manual on and off for all images The user can also edit the fields that are available on patient demographics overlay by clicking on the Edit Fields button From here the user is able to e Select a field and determine what kind of a delimiter following the field includes none space tab comma newline custom e Change the position of the fields with the up and down arrows e Remove or display a field by selecting the Print Field check e Print the title for the field i e the title Date would be printed in front of the date field After editing the fields select the Done button Print preview To see a print preview select the Print Preview button Print an image from DICOM Printer When the user has finished dragging and dropping the desired images onto the preview window and manipulating size position and window level if necessary then press the Print button
44. is not liable for any claim by or against the customer arising from a third party claim Revision History Revision Author Date Notes A MS 2010 01 12 Initial Release B MS 2010 03 22 Updated safety information C MS 2010 07 01 Updated safety information 2007 2009 xi of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual Contents Foreword 1 Contact Information brad a aid are ii Daley INoOrmaloN us mesa ratio Oe eee Ee eee wae 111 IERCO VA EA e EA BAR aia A ES he Ri Vili 1 Introduction 1 LE E Eek Be oe ee aoe eee eS ee eee So 1 2 Pre Installation 2 21 Voltage Requirements 2 24 ma be RS oh eb bee ea ee Kak aS 2 Z2L1 AC Voltage Requirements 5 a ga amp oa a Ss Mow a 2 21 2 DE Voltage Requirements es oi sas a BY G kee ew Aa 2 2 2 Environmental Requirements ire era e aa a a4 2 2 3 Connectivity and Power Supply o o 3 24 POWerowitel Loco 33 20 hn Sore AA 3 ZO POWER SE DCAN TOMS ese Sh fe ie Be Pe e a eS 3 7 0 Physical reg iremenis ps s a one 3 ote ae A ee ee oie Se ESE Bone Bo 3 27 Systems Specifications pests as ta 2228442 A ws 3 3 Hardware Installation 5 SL Unpacking TAStHUCHONS re ar oa od Mae eae SAS BE G8 5 3 2 Installing Power amp USB 2 0 Cables with Power Cowling 5 2o APDR Can WOUNG 635 4 EA 8 oe AD Wal ss eee sa Re ew oie E ok eo So 9 4 Software Installation 11 dul UBC SpecincaOns sara Be SMES
45. le holding down the mouse button will adjust the brightness while moving the mouse horizontally will adjust the contrast 6 7 5 Smart Box Window Level The Smart Box Window Level tool allows the User to automat ically adjust the brightness and contrast of the image with a user selectable box The optimal window level settings will be determined by the user defined selection To use the Smart Box Window Level tool first select it from the pop up menu on the left hand side of the screen Then mouse click and drag until the Smart Box is the desired size Upon releasing the mouse button the Window Level setting will be automatically calculated The User may resize the box at any time by selecting the Smart Box by one of the corners and dragging to the desired size The User may also move the Smart Box around the image to yield different Window Level settings by clicking and dragging from the middle of the Smart Box To hide the Smart Box and apply the settings click the Smart Box button in the toolbar 2007 2009 27 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 7 6 Rotate Clockwise Counter Clockwise The Rotate tools allow the User to rotate the im age in 45 increments To use the Rotate tools first open the pop up menu on the left hand side of the screen Then click either Rotate Clockwise s or Rotate Counter Clockwise until the desired
46. ments Image Date Time 24 February 2010 9 25 AM Plate Size 14 x 17 inches 169 DPI Exposure Index Undefined Study List 8 When the image is finished scanning make the desired manipulations and annota tions All Captera manipulation and annotation tools are selected in the Tools Menu Bar on the left side of the Image Display window 2007 2009 18 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Chestey John Cheste10000 F Operation complete Chest ESE Left LE lt e A View DOB 28 February 1967 24 February 2010 9 25 AM Institution Institution Accession 3 Commen ts 24 February 201059 25 AM Plate Size 14 XA inches 168 DPI Exposure Index Undefined Study Lisi 9 When the User is finished manipulating the image click the Accept button in the lower left hand corner of the Image Display window When the Accept button is clicked 1t will save the current image manipulations and DICOM Send the image Cheste John Gheste10000 al i Operation complete AE Exposure Index Undefined 5 3 Schedule of Maintenance The following is a schedule of maintenance for the 7DR The following maintenance may be performed by end users Maintenance Procedure Frequency Weekly Clean DR exterior covers Monthly 2007 2009 19 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 P
47. milar product Repaired and replacement products may be or include refurbished or remanufactured parts Any replacement item assumes the remaining warranty period of the original product iCRco provides no warranty for any third party hardware or software included with any product or later acquired software Limited Warranty Support iCRco warrants that its QPC XSCAN32 Captera and or ClarityPACS software originally provided with any product will substantially conform to iCRco s specifications and that the media not including hard drives on which the software is furnished will be free from 2007 2009 viii of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR _ User Manual defects in materials and workmanship under normal use for a period of one 1 year from the date of original shipment from iCRco iCRco s sole obligation under this warranty is limited to making reasonable efforts to ensure such conformity and to supply the consumer with a corrected version of the software as soon as it is practical after the consumer has notified iCRco of any non conformity iCRco does not warrant that the operation of any software will be uninterrupted glitch or error free or that functions contained in the software will operate in the combinations which may be selected for use by the user or meet the user s requirements This limited software warranty will be void if the software is modified withou
48. ministrative privileges can access the Configuration window 2007 2009 32 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Figure 6 5 Captera s Configuration Screen Text Device X Ray e Annotations Settings Tubes Defaults Users Settings DICOM Worklist Auto Send Setup Inputs Targets List of known DICOM AETs Target Type IP Address TCP Port O clarity archive clarityarchive 192 160 0 49 11112 Local Settings AET Captera_DICOM Close and Accept 6 8 1 DICOM The DICOM tab holds all the DICOM target information as well as configuration settings for DICOM Modality Work List Query and DICOM Auto Send DICOM Setup The DICOM Setup tab contains a list of AET s known to Captera From the DICOM Setup tab the User may add remove edit and test AETs using the appropriate button Work List Inputs The Work List Query tab allows the User to easily set DICOM Modality Work List Query Check the box next to the desired AET then choose the query interval 2007 2009 33 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual Auto Send Targets The Auto Send Targets tab allows the User to easily set DICOM Auto Send Check the box next to the desired AET and when an image is accepted it will be automatically send to the checked target s Pending The Pending tab prov
49. og To change these settings or to view more settings click on the Printers tab 2007 2009 Confidential and Proprietary Property of iCRco Inc Selected Printer Settings Test Printer Print to AET PRINT_DICOM Rows Columns 1x1 Media Type PAPER Film Size SINS DIN Number of Copies 1 Orientation Portrait 41 of 46 Document IDR 01A Rev C July 1 2010 DRYM_ User Manual Manipulating Images in the Preview Window The Advanced DICOM Printer allows the user to flip rotate zoom pan invert and window level images To manipulate the images select the im age in the preview window the selection will be shown by the green box surrounding the im age The user can flip rotate and invert by using the buttons on the left hand side of the DICOM Printer dialog The user can zoom by using the right mouse button on the selected image Width ERA Window 16483 _ Height 2520 Level 46566 Zoom 57 73 x Update elsje To pan the image use the left mouse button on the selected image The user can only pan the image when it is zoomed in To window level the user can either use the middle scroll button on the mouse or type the required window level into the edit boxes on the left hand side of the Advanced DICOM Printer dialog Then press the Update button to change the window level for the image The user can also press the 1 1 button to tell the Advanced DICOM Printer dialog to print images at
50. r needs to first select the region to split For example if there are currently no divisions in the preview window then click anywhere in the preview window and a green line will appear around the window This will enable the image division buttons Alternatively the user can press Shift 008 18 right mouse click inside the preview window region to split it A pop up menu will appear with these division buttons as the image to the right shows 2007 2009 40 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual TARIA amlee u aF ae bee Congres EDI sl e ery Select one of the image division buttons and the preview window will be divided into regions To split one of these regions again select the specified region and again select one of the image division buttons The user can drag and drop images at any stage If the user has an image in the region that is desired the interface will automatically move the image into the split regions To remove a division click in the region that has been split and click on the no division El button Image Divisiorrs iY Show T Lock The user can show and hide the image divisions by clicking on the Page Layout tab then click Show and Lock under Image Divisions The user can view the current print settings by looking at the left hand side of the Advanced DICOM Printer dial
51. re applications cassette cleaning amp handling and hardware installation A general description of the system s functionality and user interfaces are included This document is intended for end users who need to understand the basic operation of the iDR 2007 2009 1 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 2 Pre Installation 2 1 Voltage Requirements The DR unit can be purchased with either an AC or DC power supply Refer to Figures 3 1 and 3 2 on page 5 to distinguish the difference between to the two iCRco employs CE certified medical grade power supplies See Section 2 3 on page 3 for UPS requirements 2 1 1 AC Voltage Requirements The DR unit incorporates an international switching power supply The DR unit is supplied with an AC power supply that allows the unit to work between 90 to 253V AC 50 60Hz 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 The power input module will be set to the proper voltage setting at the factory 2 1 2 DC Voltage Requirements The DR unit is supplied with a DC power supply that allows the unit to work between 18 to 36 VDC 4 5 Amps maximum and 450 Watts iCRco provides a medical power converter Do not substitute or switch the power converter Substituting or switching the power converter will void the warranty Con
52. rial Authorization RMA number from iCRco Prior to providing an RMA iCRco may require remote access to the product If iCRco determines that the product may be defective is under warranty and necessitates a return to iCRco for service an RMA number and instructions for return of the product will be given iCRco is not responsible for any unauthorized returned product i e one for which an RMA number has not been issued by iCRco Warranty service requires all authorized returns be shipped to the iCRco factory prepaid and insured All such authorized returns are the customer s responsibility For products sold and located within the United States iCRco will pay for return shipping Products being returned are only to be shipped in iCRco approved shipping containers The original box and packaging materials are approved and should be kept for moving and or shipping the product Approved packaging my also be purchased from iCRco for an additional charge iCRco shall have no liability nor responsibility for warranty service to any product that is not shipped in an iCRco approved shipping container or that is damaged from incorrect packaging or damaged during shipping Additional Warranty Limitations and Extent of Warranty This warranty does not apply if the product has been damaged by accident misuse or abuse In addition warranty service does not include the repair of failures or defects caused by unauthorized attachments to any iCRco
53. roperty of iCRco Inc iDR User Manual The following DR maintenance must be performed by an iCRco authorized service engineer only Maintenance Procedure Frequency Yearly Yearly Clean fan filters Monthly or when visibly dirty The following DR calibration maintenance must be performed by an iCRco authorized service engineer only Maintenance Procedure Frequency Check image performance Contrast Noise Ratio and Spacial Resolution Perform Exposure Index calibration 5 4 Periodic Cleaning Periodic cleaning of iCRco products should be done on a monthly basis 5 4 1 Cleaning the Outside of the DR It is important that the covers remain on the DR at all times The covers should only be removed for service by an iCRco authorized technician then immediately replaced A CAUTION Do not clean the galvo mirror Dust and fibers in the laser beam path may affect the radiographic image The outside covers of the DR should be cleaned with a slightly dampened cloth or a dry cloth moistened with BallQSUNUP glass cleaner or Sprayway Oglass cleaner 5 4 2 Cassette Cleaning A CAUTION At no time should abrasive cleaners or chemicals be used to clean the cassette or plate Cleaning the Outside of the Cassette 1 Moisten a clean lint free cloth with a mild soap or detergent using soft water 2 Wipe down the cassette covers thoroughly 3 Allow the cassette to air dry 2007 2009 20 of 46 Document IDR
54. rotation is me A ele mouse click on the Clockwise or Counter Clickwise button will rotate the image 45 6 7 Flip Vertical amp Horizontal The Flip tools allow the User to invert the im age either horizontally or vertically To use the Flip tools first open the pop up menu on the left hand side of the screen Then click either Flip Vertical or Flip Horizontal until the desired orientation is achieved 6 7 8 Information Overlay The Overlay tool allows the User to show hide the patient information associated with the image currently being viewed To use the Overlay tool first open the pop up menu on the left hand side of the screen Then click the Overlay button until the desired amount of patient information is displayed on screen 2007 2009 28 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 6 7 9 Hide Show Annotations The Hide Show Annotations tool allows the User to show or hide the annotations for the current image To use the Hide Show Annotations tool first open the pop up menu on the left hand side of the screen Then click the Hide Show An notations button to hide or show the annotations on the current image NOGI If annotations are hidden no new annotations can be made on the image To make a new annotation make sure the annotations are not hidden 6 7 10 ICE2 Processing The ICE2 Processing allows the User to appl
55. t the written approval of iCRco or is used outside of the recommended parameters or equipment iCRco does not provide any warranty or support for any other software iCRco agrees to provide one 1 year of telephonic and or e mail based support for QPC XSCAN32 Captera and or ClarityPACS software originally provided with any new iCRco product from the date of original shipment from iCRco All software support shall be limited to making reasonable efforts to resolve iCRco software issues and shall be limited to iCRco s regular business hours In addition iCRco will provide revisions and upgrades to its software upon request when available during the first year after the software was originally shipped from the iCRco factory The initial support period will include support via remote login software GoToMeeting only if the customer has access to the Internet from that PC and only if the customer agrees iCRco shall have no liability in connection with its support efforts Remote login software allows iCRco technical support to remotely access the customer s PC via the Internet for the purposes of rendering technical support Please note that this warranty including software support does not include computer hardware third party software or operating system or network issues which are outside the control of iCRco Warranty Product Technical Requirements iCRco requires that all DR CR Scanner and or products requiring PCs be fitted and inst
56. tact iCRco Tech Support to obtain a replacement power converter 2 2 Environmental Requirements The DR should not be placed in a room with a film processor present This will void the warranty The humidity and temperature limits are 20 to 80 non condensing and 15 F to 95 F 15 C to 35 C operating respectively The room should have good ventilation Another factor to consider prior to installing the DR is dust and particulates in the environ ment The iDR is designed to be resistant to dust and particulates that may be present at the installation site Installation of the DR near high magnetic fields may cause the CR unit to malfunction The iDR should not be placed in a room with an MRI CT or any other equipment that produces high magnetic fields The room should have good ventilation It is recommended that the unit be installed and operated in a clean dry environ ment 2007 2009 2 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc iDR User Manual 2 3 Connectivity and Power Supply The room needs to have wall power and the iDR should not be used with an extension cord Use at least a 1300VA 780W uninterruptible power supply UPS between the wall power and the DR 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 2
57. the Top Mount End Cap off the DR mount 3 With at least two 2 people lift the DR into the Bottom Mount End Cap Always practice proper heavy lifting procedures Improper lifting may cause injury 4 Refasten nine 9 6 32 x 3 4 flathead screws to the Top Mount End Cap 5 Carefully remove the Spring Mount screw 2007 2009 8 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRYM_ User Manual 3 4 DR Wall Mount Wall mounting equipment must be installed by a licensed contractor Do not remove the Spring Mount screw shown below until the DR has been secured in the mount The DR Spring Mount screw 1 Position the Wall Mount in the desired location on the wall 2 Allow the contractor to determine the precise location and proper screws to fasten the Wall Mount to the wall The Wall Mount should be fastened to the wall through the four 4 available mounting holes 3 Remove nine 9 6 32 x 3 4 flathead screws from the Top Mount End Cap 2007 2009 9 of 46 Document IDR 01A Rev C Confidential and Proprietary July 1 2010 Property of iCRco Inc DRYM_ User Manual 4 Ease the Top Mount End Cap off the DR mount 5 With at least two 2 people lift the DR into the Bottom Mount End Cap HEAVY LIFT Always practice proper heavy lifting procedures Im proper lifting may cause injury 6 Refasten nine 9 6 32 x 3 4 flathead screws to the
58. y different image enhancements to the image By default every image receives Standard processing If the Standard processing is not adequate the User may reprocess the image to suite their needs The Soft process will yield a more film like image i e finer tonal eradation with less sharpness while the Sharp process will yield an image with more contrast and greater edge sharpness To use ICE2 Processing first open the pop up menu on the left hand side of the screen Then click the desired processing button Depending on the computer speed the process may take a minute The progress is shown in the image thumbnail on the right hand side of the screen while the image is being processed it will say processing in the lower left hand corner of the image thumbnail 6 7 11 Arrow The Arrow tool allows the User to draw an arrow on the image To use the Arrow tool first select it from the pop up menu on the left hand side of the screen Then click hold and drag out the arrow to the desired length and position Release the mouse button when the arrow is sufficient 6 7 12 Line The Line tool allows the User to draw a line on the image To use the Line tool first select it from the pop up menu on the left A hand side of the screen Then click hold and drag out the line to the desired length and position Release the mouse button es sufficient 2007 2009 29 of 46 Document IDR 01A Rev C Confidential

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