Apple Mac OS X Server System Imaging and Software Update Administration For Version 10.4 or Later Manual de usuario descargar pdf (Pagina 15)

White Paper

Integrating Mac Systems into

a Medical IT Infrastructure

Apple Cinema Display 2 Result: 232.1

Category A target: > 200

Category B target: > 120

Result: 331.57

Category A target: > 100

Category B target: > 40

Result: 11.5%

Category A target: ± 15%

Category B target: ± 20%

Display Quality Conrmed

The Apple Cinema Displays passed all the required tests and were approved for

diagnostic use. One display panel, however, featured a somewhat nonuniform display

characteristic and must be tested more frequently than every 90 days. This may lead

some facilities to reserve the use of this system for Category B applications, although

the display did meet prescribed standards for all applications.

Conclusion—Apple Cinema Displays meet image quality requirements for radiology

reporting in all application categories. The Apple displays met all standards, including

grayscale presentation standards, and passed conformity tests. Constancy tests also showed

that the displays met standards for brightness and contrast. However, in homogeneity tests,

variations in luminance in the panel corners call for more frequent constancy testing in the

future. The Apple Cinema Display antireection coating also causes a slight blurring eect

on brighter parts of chest X-rays. Response from radiologists to this limited phenomenon

varied, and many found it had no negative impact. (We recommend that forthcoming

Apple Cinema Display models be reevaluated regarding homogeneity and coating.) These

few shortcomings may lead some facilities to reserve the use of this system for Category B

applications. With the availability of display-independent calibration software, users can

implement other display types for Category A applications.

OsiriX Software Installation and PACS Integration

To view and postprocess radiological images, the team had to install OsiriX imaging

software and integrate the workstation into the hospital’s PACS.

Certied Viewing Software: Meeting FDA and CE Regulations

In most countries, software used for medical image reading has to fulll certain legal

requirements. These include developing the software in a well-dened and managed

process and under quality and risk management controls. Requirements also cover

such aspects as software documentation (DICOM conformance statements, technical

and user documentation, etc.) and an incident management system. Using a system

developed according to these standards results in reliable, reproducible, and consistent

outputs under stable conditions.

The uid nature of open source software development, however, makes such a process

dicult. Ongoing community development means that open source code can change

constantly, and these changes may render the application unstable—and would also

make any QA result invalid.

Fortunately, third-party institutions can select a dened development state of an

application and use that version for bug xes, enhancements, and modications.

Once the software clears the processes required for use under U.S. FDA and European

CE regulations, the application can be oered as a complete solution with software,

manual, service, support, and more. This enables hospitals to acquire OsiriX versions

that have been processed according to either U.S. or European regulations.

The Open Source OsiriX version may be used for some professional clinical work, but

this is not recommended, as any malpractice issues caused by software errors must

then be handled by the user.

aycan workstation OsiriX

PRO

aycan workstation OsiriX

PRO

is a modied

version of OsiriX from aycan (www.aycanus.com,

www.aycan.de). (See Figure 9.) The software has

earned 510(k) clearance for use as a medical

device according to the United States Food and

Drug Administration (510(k) Number: K063470),

and it has a CE certicate for use throughout

the European Economic Community and Turkey.

Available commercially, aycan workstation

OsiriX

PRO

incorporates bug xes and validated

and exclusive plug-ins. Furthermore, the software

comes with a comprehensive user manual, a com-

puter-based training CD, and

various training and service options.

Figure 9: aycan workstation OsiriX

PRO

has earned

FDA clearance and has a CE certicate, clearing

it for use in hospitals in the United States and

Europe. Here, the solution is used for postprocess-

ing an Angio CT using 3D Volume Rendering.

1 2 ... 10 11 12 13 14 15 16 17 18 19 20

Comentarios a estos manuales

Sin comentarios

Apple Mac OS X Server System Imaging and Software Update Administration For Version 10.4 or Later Manual de usuario Pagina 15

Comentarios a estos manuales

Relacionado con productos y manuales para Software Apple Mac OS X Server System Imaging and Software Update Administration For Version 10.4 or Later