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AQUATM Radiology is a machine Quality Assurance management solution that standardizes, streamlines and automates QA procedures throughout rediology department and across multiple sites. AQUATM Radiology is a customizable, scriptable web-based application hosted on a server within the department, using the existing network. Key Features AQUATM Radiology manages and standardizes QA Audit reports, highlighting missed tests or summarizing procedures for all types of diagnostic imaging routine test results, are easily created. equipment, regardless of vendor. QA data plots can be generated over time to allow trend AQUA TM Radiology centralizes QA test results, test analyses. records, machine details and machine status history. AQUATM Radiology interfaces with select 3rd party QA devices to import test results and data directly. SMOOTH ROUTINE USE Current status of all equipment across the department can Users can search the Library and run QA tests off be monitored at a glance from the Dashboard, with easy schedule (e.g. after a service event). access to test results of interest. AQUATM Radiology provides an electronic machine log book A user-specific To Do List of standardized QA procedures to log machine Events and aid root cause analysis, with guides workflow and displays test compliance. email notifications. AQUATM Radiology tracks the Status of each machine AQUATM Radiology provides an inventory of equipment (e.g. Working-Clinical, QA, Out of Service, etc.) and reports and QA devices. machine uptime based on machine status history. Custom machine reference data can be stored and defined for use as test inputs or baselines. AQUATM RADIOLOGY TESTS AQUA DxTM incorporates a wide range of tests with different AQUA DxTM allows users to track equipment calibration levels of complexity and automation, including: factors and expiry dates, including pairs of equipment. Email notification informs users of pending calibration expiry. Binary Pass/Fail tests (e.g. daily safety checklist). Color-coded mandatory safety test indicators help ensure safety-critical systems are tested. 1

OPEN AND CONFIGURABLE AQUATM Radiology allows users to: All QA tests are driven by customizable XML test scripts, which can be uploaded or edited through the UI. set tolerance and baseline values for each test instance. Existing in house QA routines can be executed as Java schedule test instances to individual users or user roles. libraries by AQUATM Radiology XML test script, with outputs directly to AQUATM Radiology. custom anchor dates for QC tests performed every n-weeks. User-defined machine groups are shown on the Dashboard. Form-based tests with manual entry of results. A flexible machine model describes imaging equipment in Tests that interface with common QA devices to control the AQUA TM Radiology, allowing users to define the mechanical device or import test results. and dosimetric characteristics of their equipment. Automated image-based tests for image quality analysis. AQUATM Radiology user permissions are based on user or AQUATM Radiology incorporates a safety mechanism to user role. ensure that automated tests are performed on the correct machine and from the correct location. There is no limit to the number of users, user roles, tests or machines that can be defined in AQUATM Radiology. Active Directory user account logins are supported. All tests are XML script based. The test editor allows existing tests to be customized or new tests to be created, specific to the needs of the department. Tests and schedules recommended in the following protocols (table 1) are included with AQUATM Radiology as standard: TABLE 1: AQUATM RADIOLOGY PRE-CONFIGURED QA PROTOCOLS ORGANIZATION PROTOCOL DESCRIPTION DATE ACR Quality Control Manual Quality Control of computed tomography 2012 JCAHO Diagnostic Imaging Requirment Diagnostic computed tomography (CT) 2015 services IAEA Human Health Series CT performance tests 2012 Quality assurance for computed 2003 No.19 AAPM TG-66 tomography simulators 2

AQUATM RADIOLOGY All data from the QA program are stored in AQUATM Radiology, allowing several reports to be generated with user-defined ranges and parameters, as described below: TABLE 2: AQUATM RADIOLOGY DESCRIPTION TYPE DESCRIPTION OF CONTENTS EQUIPMENT Machine Uptime Summary of time spent in each available machine status for selected machines, computed against nominal working day and clinical working week as defined in AQUATM Radiology. Machine Details Description of machine components and machine reference data mapped to the selected machine. Equipment Summary Information about all machines of the selected type (machine name, model, vendor, serial number, commissioning and decommissioning date, active status). QA POLICY Compliance Summary of QA tests performed on a machine within a selected date range, compared to expected tests. Policy Compliance Audit of test instances created for a machine and summary of deficiencies against ACR recommendations. QA TEST Test Procedure Procedure and specification for each selected test. Test Runs Summary of selected test instances, including test instance name, test run pass/fail status, test run date, user who executed the test run, whether test instance is currently scheduled, and whether test was in draft mode at time of test run. Test Inputs Test Runs report data plus values of all parameters used in the test run. Test Parameters Current values of all test parameters in each test instance for the selected test on the selected machine. Test Run Details Values of all parameters for each test run of selected test instances in the selected time period. Test Run by Period Values of all parameters for each test run scheduled at the selected testing frequency in the selected date range. 3

AQUATM RADIOLOGY DATA PLOTS AQUATM Radiology helps to identify trends in data and potential equipment issues using customizable data plots with the following features: Display of baseline, tolerance, and limit ranges. Plots can be generated for any test parameter saved in AQUA DxTM. Plot views are driven by the XML test script, Machine events overlaid on top of plots to help interpret allowing users to review and trend the most relevant results. data. Each plot can be viewed as absolute data, absolute Ability to zoom in on areas of interest, select data points to difference from baseline and relative to baseline. review, and click to access test input forms. Plots can be exported as data (.CSV files) or images. Trending over time for data or vectors, such as beam profiles and depth-dose curves. FIGURE 1: Easy to use plots display user selected data trended over time. Images generated during test runs offer visual verification of results Spatial Resolution Spatial Resolution - Circular Profile 4

AQUATM RADIOLOGY COMPATIBILITY AQUATM Radiology is an open, vendor-neutral system. Its tests can be performed for all imaging devices. It performs fully automated image performance tests for computed tomography scanners using Catphan phantom. Table 2 shows compatibility with Catphan phantom models and relevant automated tests. TABLE 2: AQUATM RADIOLOGY V2.0 COMPATIBILITY WITH CATPHAN PHANTOMS PHANTOM MODEL AUTOMATED IMAGE PERFORMANCE TEST AUTOMATED ELECTROMECHANICAL TESTS CATPHAN 600 Slice sensitivity profile Low-contrast resolution CATPHAN 500 Low-contrast resolution CATPHAN 503 CATPHAN 600 Low-contrast resolution 5

AQUATM RADIOLOGY OVERVIEW FIGURE 2: AQUATM Radiology network diagram describing the software and hardware configuration on the client network. Users access AQUATM Radiology through a web browser Only an AQUATM Radiology Trusted Workstation can on an AQUATM Radiology Workstation. Users are execute QA tests that connect to imaging devices. authenticated either on the AQUATM Radiology Server or via the hospital s Active Directory system. The Mobile Machine Dashboard is a web application accessed within the client s private network. Figure 2 AQUA Dx 6

SYSTEM REQUIREMENTS User credentials can be managed locally by AQUATM Radiology or through the hospital s Active Directory. SERVER HARDWARE SERVER OPERATING SYSTEM Intel Xeon CPU E5-2670 @ 2.6 GHz (2 processors) Windows Server 2008 R2 Standard 64-bit OS 32 GB DDR4 RAM Windows 7 Professional Disk Space AQUA TM Radiology software: < 1 GB SUPPORTED BROWSERS IE 11 Database: 5 GB Chrome V44.0.2403.125 or later Image-Based Tests: 20 GB/year/machine Firefox 39.0 or later Minimum recommended screen resolution is 1024x768. Safari Version: 8.0.7 (10600.7.12) or later REGULATIONS AQUATM Radiology is not a medical device, nor is it intended for use in the diagnosis, cure, treatment, or prevention of disease. For American customers: in accordance with the Code of Federal Regulations, Title 21, Sections 800-1299, AQUATM Radiology is not a medical device. For Canadian customers: AQUATM Radiology is not a medical device as per Medical Device Regulations SOR/98-282. For European customers: AQUATM Radiology is not a medical device as defined in the Council Directive 93/42/EEC of 14-June-1993 concerning medical devices. AQUATM Radiology is not intended for collection, storage, processing, or analyzing of patient data to support or influence the medical care provided to that patient. LEGAL AQUATM Radiology is developed by Acumyn Inc. (Toronto, Canada). SOFTWARE INSTALLED WITH AQUATM RADIOLOGY COMPONENT SOFTWARE PROVIDER VERSION DICOM server CTP RSNA 2015.09.13 Web Server Tomcat Apache Software Foundation 7.0.61 Database SQL Server 2008 R2 Microsoft 2008 R2 Java Java SE Development Kit 7 update 79 Oracle Kit 7 Update 79 icom Agent AQUATM Radiology icom Agent Acumyn 1.0 7