Home - GE Healthcare Centricity Radiology Mobile Access for iOS 3.1 Operator Manual

1. About Centricity Radiology Mobile Access

1.1 Centricity Radiology Mobile Access Intended Use

Centricity Radiology Mobile Access is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for co mmunication, storage, re formatting, rendering on the server component and communication a nd display of DICOM 3.0 compliant medical images.

Centricity Radiology Mobile Access is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user’s responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Centricity Radiology Mobile Access is not to be used for mammography.

1.2 Expected Performance

CRMA is not required to download full DICOM images to your mobile viewing device: study images move between the PACS and the CRMA server within the hospital network. The delivery of rendered images from the server to the mobile device will vary somewhat over different network types depending on bandwidth availa bility i.e. raw speed of the network, either Wi-Fi or 3G cellular, and network latency, i.e. inherent delays on the network. In any case, we hav e observed that once communication is established to the server, typical data sets will be fully loaded on the server and available for initial viewing on the mobile device in 8 to 15 seconds.

The following table characterizes the loading time in seconds for a “small” (38-slice, ~19MB) and “medium” (426-slice, ~213MB) CT data sets under 3 network conditions: WiFi, “Good” 3G and “Poor” 3G. The “Poor” 3G connection was simulated using the well-known iPhone 4 antenna issue (http://en.wikipedia.org/wiki/IPhone_4#Antenna), which can be used to reproducibly reduce the signal strength to the device by 2 “bars” (i.e. from 4 or 5 with a “good” signal, down to 2 or 3). The loading times were calculated by averaging the time taken by 3 consecutive loads of the data set.

Data Set Wi-Fi “Good” 3G “Poor” 3G
Small (38 slices) 8.3 9.7 13.5
Medium (426 slices) 11.3 13.2 115.0

1.3 Release Notes

Release notes are issued with this product-visit our Common Documentation Library at:
http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library .

If the information in the release notes differs fr om the information in this guide, follow the instructions in the release notes.

1.4 Contacting GE Support

Centricity Exam Manager (CEM) is a Web-based application that works with patient and exam records that are stored on a Centricity Picture Archivin g and Communication System (PACS).

Users cannot modify historical digitized images, mark exams as reference only, edit standard report headers, add standard report templates, or cancel exams on PACS. This should not be crucial for treatin g a patient's current condition. All the images of a patient, from a recent modality scan to any historical images, are available to the user. However, the match of the latest images to the historical images may be delayed and will require manual intervention.

1.4.1 Contacting the ROC

Contact information for the ROC (Remote Online Center):

OLC/USA OLC/Europe OLD/ANZ
1-800-321-7937 (US/Canada) +33 (0) 30 831300 61-2-316-3700
1-262-524-5300 (elsewhere)    

1.4.2 Applications Support and Service Support (Asia Regions)

To request applications support or service support for the Asia regions, refer to the following phone numbers.

Country Support Phone Number
Australia 1800659465
China 8008108188
Hong Kong 21006288
India 1800114567
Japan 0120055919
Korea 15446119
Malaysia 1800883911
New Zealand 0800659465
Singapore 63880932
Taiwan 0800021770

1.4.3 Applications Support Using iCenter, Applications Answerline, Customer Center

To request applications support, English-speaking customers may open a support request in GE Healthcare iCenter™. Other customers should contact their GE Field Engineers or support personnel.

With GE Healthcare iCenter™ you can:

  • Initiate requests for service and applications support from the web.
  • Get rapid, online access to the Remote Operation Center (ROC) where expert service engineers review and respond to service requests quickly.
  • View status of open service requests.
  • View service history and reports about your systems, including uptime, remote fix and service call trends, and other service delivery metrics.

If you do not have access to iCenter, contact your Director of Service or Service Engineer to open an iCenter account. English-speaking customers can also use the following resources:

  • GE PACS Applications Answerline 1 (800) 682-5327, Option 8 (available for US and Canadian customers)
  • PACSApplicationsHelp@med.ge.com
  • GE Healthcare Centricity PACS Customer Center (http://supportcentral.ge.com and select GE Healthcare - Global Centricity PACS Customer Center). Use this web portal to access documents, FAQs, exchange documents, and participate in forums with other GE PACS customers.

To register for access to this resource, complete the Support Central Community Subscriber Application.

1.4.4 CE Mark Information

Centricity Radiology Mobile Access bears CE mark “CE-0459”. Conformity assessment procedure for CE marking: Medical Device Directive, 93/42/EEC, Annex II, Section 3.2.

1.4.5 Contact Information for GE Healthcare Offices

Addresses and phone numbers for GE Healthcare office is listed below.

Corporate Headquarters

MANUFACTURER

GE Healthcare
540 W Northwest Highway, Barrington, IL 60010 USA
Tel: +1 847 277-5000 or +1 800-437-1171 or +1 800-682-5327
Fax: +1 847 277-5240

European Authorized Representative

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

GE Medical Systems SCS
283 rue de la Minière, 78530 BUC, France

Asia Headquarters

GE Healthcare
1 BLD-3F, No. 1 Hua Tuo Road, Zhang Jiang Hi-Tech Park, Shanghai 201203 China
Tel: 8621-38777888
Fax: 8621-38777499

1.5 Documentation Conventions

1.5.1 Text

This typeface represents all menu and sub-menu names within procedures, for example:
On the File menu, click New.

1.6 Screen Captures

The example screens in this manual may not re present what you see on your monitor; use them only as guidelines

1.7 Safety

1.7.1 For Your Safety

Intended Use

Centricity Radiology Mobile Access is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for co mmunication, storage, re formatting, rendering on the server component and communication a nd display of DICOM 3.0 compliant medical images.

Centricity Radiology Mobile Access is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user’s responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Centricity Radiology Mobile Access is not to be used for mammography.

Terminology

The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of se riousness. Hazard is de fined as a source of potential injury to a person.

Familiarize yourself with th e terminology descriptions lis ted in the following table:

Notice Type Description
Danger Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
Warning Indicates a potentially hazardous situation, which, if not avoided, could result in death or serious injury.
Caution Indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury.
Note Indicates informational messages providing application tips or other useful information that do not pertain to a hazard.

System Safety

The safety statements in this chapter refer to the equipment in general. Additional safety statements specific to particular operations of the product can be found in the applicable chapter describing that operation.

Dangers

There are no dangers that refer to the equipment in general. Specific "Danger" statements may be given in the respective sections of this manual.

Warnings

The warning statements in th is section refer to the equipment in general. Additional warning statements specific to particular operations of the product can be found in the applicable chapter describing that operation.

Warning: DICOM Data: Usage of the data available extracted from the attributes of DICOM (Digital Information and Communication In Medicine) images and DICOM information objects displayed on PACS to solely determine the clinical condition of a patient is not recommended. This is due to likely variations of implementation and interpretations of attributes by respective medical device suppliers, which could lead to a misdiagnosis. Ensure that sound clinical knowledge, practices and expertise are in place to substantiate the information provided and displayed on PACS for diagnosis. Ensure displayed measurements, images and other visual indications are complete and consistent with patient history prior to finalizing diagnosis or treatment.

Warning: CRMA should only be used by professionals qualified to review the pathology relevant to the diagnosis.

Cautions

The caution statements in this section refer to the equipment in genera l. Additional caution statements specific to particular operations of the product can be found in the applicable chapter describing that operation.

Caution: Restricted Sale: Federal law restricts this device to sale by or on the order of a physician.

Caution: Customer-Supplied Hardware: Hardware supplied by the customer must meet all applicable standards listed under Certifications.

Considerations

Centricity Radiology Mobile Access displays DICOM image data and exam reports that are available on Centricity PACS at the time of access. It does not display exam notes, annotations, significant images, key image notes, and other database information that may typically be viewed on a traditional workstation such as RA1000, Centricity Web, or Centricity PACS Web Diagnostic. In addition, some images might still be in the process of being acquired when the exam is accessed from the mobile device. Do not use Centricity Radiology Mobile Access on its own for any clinical decisions.

Images must be online on short-term storage to be displayed by Centricity Radiology Mobile Access. Offline exams can be fetched for display.

Image and report display speed depends on system connectivity. Low-bandwidth connections will result in slow displays of images and reports. For best results, verify that you have at least 3G service.

Certain views make use of interpolated data. This is data that is created by Centricity Radiology Mobile Access based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. On occasion, interpolated data may also include image artifacts which should not be interpreted as real pathology.

While you are viewing any images and reports from their mobile device, any real-time updates on image information or availability will not automatically be seen in your current viewing session. These updates can only be viewed if you perform a new search and re-access the updated study.

The software is not intended to replace the skill and judg ment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software’s functions, capabilities and limitations.

The user should be aware of the limitations in the accuracy and correctness of the output data displayed on the screen, printed, or exported from CRMA. The quality of the data is dependent on the correctness of the input data , the user’s interaction with the data, the quality, characteristics, and sett ings of the display device or printer, the amount of ambient light in the vicinity and the necessity to interpolate the data for display purposes. For example, measurement values in CRMA are dependent on the calibration information provided by the modality in the DICOM header.

1.7.2 Certifications

The Centricity Radiology Mobile Access system was designed in accordance with:

  • IEC 62304 - Medical Device software - Software life cycle process
  • EN 62366 - Medical Devices - Application of usability eng ineering to medical devices

1.7.3 Definition of Symbols Used In This Manualz

The following table defines symbols used throughout this document and/or the product software:

Symbols Definition
AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY This symbol indicates the AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY of the product.
MANUFACTURER This symbol indicates the MANUFACTURER of the product.
DATE OF MANUFACTURE This symbol indicates the DATE OF MANUFACTURE of the product.
BATCH CODE This symbol indicates the manufacturers BATCH CODE, or lot number of the product.
CAUTION This symbol for CAUTION highlights the fact that there are specific warnings or precautions associated with the device.
WEEE The WEEE symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
Rx Only For products distributed in the US , the symbol for “Rx Only” indicates:
Caution: Federal law restricts this device to sale by or on the order of a Physician.

1.8 Software License; Intellectual Property

1.8.1 Preamble

Any software provided to the customer is subject to the specific license terms and conditions of the applicable agreement, or shrink-wrap, or click-wrap license.

In the event of any conflict between those sp ecific terms described below, the specific terms will supersede and prevail.

Generally those terms provided are as follows.

1.8.2 License Grant

GE grants to Customer a limited non-transfer able license to use the Licensed Software subject to the limitations imposed under this Agreement and to the following:

The Permitted Users shall use the Licensed Software only on the Equipment located at the Site and solely for the purpose of processing, storing, and transmitting images and data related to Customer's patients. Customer must obtain a supplementary license from GE (which GE may or may not grant, at its option) before using the Licensed Software (a) in connection with any equipment compone nts other than the Equipment (except as expressly contemplated by this Agreement or any applicable Software documentation); (b) at any location other than the Site, or (c) to process, store, or transmit data related to patients other than Customer's patients.

Customer may make one copy of the Licensed Software in machine- readable form solely for backup purposes and shall reproduce on any such copy the c opyright notice and any other proprietary legends that were on the original copy.

Customer shall comply with all restrictions on the use of Licensed Software that Customer is subject to as a licensee or sublicensee of GE under the terms of licenses or other agreements or arrangements with third parties.

1.8.3 Restrictions

Except as necessary for Customer to exer cise its express rights hereunder, Customer may not itself or allow any third party to (i) make copies of the Licensed Software, (ii) distribute the Licensed Software to others, (iii) electronically transfer the Licensed Software from one computer to another over a network, or (iv) decompile, reverse engineer, disassemble, or otherwise reduce the Licensed Software to a human perceivable form. CUSTOMER MAY NOT MODIFY, ADAPT, TRANSLATE, RENT, LEASE, LOAN, RESELL FOR PROFIT, DISTRIBUTE, NETWORK, OR CREATE DERIVATIVE WORKS BASED UPON THE LICENSED SO FTWARE OR ANY PART THEREOF.

1.8.4 Ownership of Media

The media on which the Licensed Software is recorded or fixed is Customer's property. If Customer receives Licensed Software hereunder that renders Licensed Software that Customer has previously received redundant, Customer will return the redundant Licensed Software to GE or certify in writing that all copies of such Licensed Software have been erased.

1.8.5 Proprietary Service Materials

In connection with the installation, configur ation, maintenance, repair, and/or de-installation of the Equipment, Seller may deliver to or store at the Site, or attach to or install on the Equipment, and use an InSite Package. Buyer acknowledges that it has not purchased or licensed from Seller any InSite Package. Buyer hereby consents such delivery, storage, attachment (provided that such attachment does not affect functionality or performance of the Licensed Software or the System), installation, and use, and to the presence of Seller's locked cabinet or box at the Site for storage of all or part of the InSite Package, and to Seller's removal of all or any part of the InSite Package at any reasonable time, all without charge to Se ller. The presence of the InSite Package at the Site will not give Buyer any right or title to the InSite Pack age or any license or other right to access or use the InSite Package. Any access to or use of the InSite Package by anyone other than Seller is prohibited. Buyer shall use reasonable efforts to protect the InSite Package against damage or loss and to prevent any access to or use of the InSite Package contrary to such prohibition.

1.9 Revision History

Verify that you are using the most recent copy of this manual. All current manuals are available on our Common Documentation Library at http://www.apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library

Revision Date Reason For Change
1 March 2011 Centricity Radiology Mobile Access 1.0 Release
2 September 2011 Centricity Radiology mobile Access 1.1 Release
3 November 2011 Centricity Radiology Mobile Access 2.0 Release
4 July 2012 Centricity Radiology Mobile Access 3.1 Release