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( ( Picture Archiving and Communication Picture Archiving and Communication System System ) ) FDA 510K #K072637 FDA 510K #K072637 Introduction to Introduction to

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Page 1: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

((Picture Archiving and Communication SystemPicture Archiving and Communication System)) FDA 510K #K072637FDA 510K #K072637

Introduction toIntroduction to

Page 2: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

Picture Archiving and Communication SystemsPicture Archiving and Communication Systems (PACS) (PACS) are computers and other computerized hardware which run are computers and other computerized hardware which run software programs dedicated to the storage, retrieval, software programs dedicated to the storage, retrieval, distribution and presentation of medical diagnostic images, video distribution and presentation of medical diagnostic images, video and data. and data.

Imaging Modality

Review Workstation

Data Storage

Modem

Internet

Remote Access

Page 3: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

A Picture Archiving and Communications System A Picture Archiving and Communications System consists of four major hardware componentsconsists of four major hardware components::

1.1. the the imaging modalityimaging modality such as Ultrasound, MRI, CT, such as Ultrasound, MRI, CT, etc.etc.

2.2. a a secure networksecure network for the transmission of the for the transmission of the information, information,

3.3. archivesarchives for long and short term storage and for long and short term storage and retrieval of images and reports.retrieval of images and reports.

4.4. workstationsworkstations for interpreting and reviewing images. for interpreting and reviewing images.

Page 4: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

PACS SoftwarePACS Software

PACS software falls into 4 major categoriesPACS software falls into 4 major categories1.1. Software which Software which createscreates the images and data the images and data2.2. Software whichSoftware which stores stores the images and data the images and data3.3. Software whichSoftware which transports transports the images and data the images and data4.4. Software which Software which displaysdisplays the images and data the images and data

Page 5: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

PACS ArchitecturePACS ArchitectureDIVO consists of a laptop DIVO consists of a laptop computer, mounted onto an computer, mounted onto an ultrasound machine or imaging ultrasound machine or imaging device and a network attached device and a network attached storage box which stores and storage box which stores and distributes the images, movies distributes the images, movies and reports, either locally or and reports, either locally or remotely, in a secure HIPAA remotely, in a secure HIPAA compliant manner. compliant manner.

Page 6: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

Beside the fact that DIVO can be added to any Beside the fact that DIVO can be added to any imaging system, old or new, DIVO creates and imaging system, old or new, DIVO creates and enables electronic images and movies about enables electronic images and movies about 1/100 the size of dicom files. This enables them 1/100 the size of dicom files. This enables them to be archived, accessed and transmitted easily to be archived, accessed and transmitted easily and quickly, eliminating the need for cds and and quickly, eliminating the need for cds and couriers.couriers.Traditional dicom has worked well for radiologic Traditional dicom has worked well for radiologic images for many years but still falls far short images for many years but still falls far short when it comes to echo and other motion studies.when it comes to echo and other motion studies.

WHY DIVO?

Page 7: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

Because DIVO is a laptop it can…1. Access previous studies right at the imaging device: DIVO can electronically access previous studies and play them directly at

the imaging device.2. Access studies remotely: DIVO, unlike conventional Echo PACS

systems, provides rapid off-site access over the internet. It enables practitioners in different physical locations to access the same information simultaneously and it is able to provide doppler audio, triplex, and longer videos than dicom can.

3. Access networked software: DIVO provides the electronic platform for accessing other medical automation systems such as Hospital Information Systems (HIS), Electronic Medical Records Systems (EMR) and Radiology Information Systems (RIS) at the imaging station. It can make CDs and DVDs there too.

4. Access the internet: DIVO can provide access to email, educational materials and other internet resources, from the imaging device.

Page 8: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

Divo File FormatDivo File FormatMULTIMEDIAMULTIMEDIA is the standard is the standard DIVO DIVO usesuses

forfor handling, storing, printing, handling, storing, printing, and and transmitting information transmitting information using using all possible media and transport methods, including DICOMall possible media and transport methods, including DICOM. .

Multimedia is not specific to medical imaging. Multimedia is not specific to medical imaging. Multimedia includes numerous Multimedia includes numerous file formatfile format definitions and definitions and networknetwork

communications communications protocols to enable communication between systems. protocols to enable communication between systems. Multimedia files can be exchanged between two entities that are capable of Multimedia files can be exchanged between two entities that are capable of receiving image and patient data in a variety of formats. The multimedia receiving image and patient data in a variety of formats. The multimedia standard includes both standard includes both mediamedia (data storage and transmission) and (data storage and transmission) and contentcontent (information) that use a wide (information) that use a wide varietyvariety of different of different software programssoftware programs. .

Multimedia includes a combination of Multimedia includes a combination of texttext, , audioaudio, , still imagesstill images, , animationanimation and and videovideo, using content forms which may also include , using content forms which may also include DICOMDICOM..

Multimedia content can be recorded and played, displayed or accessed by Multimedia content can be recorded and played, displayed or accessed by information processing software on devices such as computers, DVD players information processing software on devices such as computers, DVD players and computerized devices like cell phones or ultrasound machines.and computerized devices like cell phones or ultrasound machines.

The communication protocols used for multimedia files can be any The communication protocols used for multimedia files can be any HIPAAHIPAA compliant method including but not limited to compliant method including but not limited to SFTP SFTP (secure file transfer (secure file transfer protocol), protocol), VPNVPN (virtual private networking) with (virtual private networking) with TCP/IPTCP/IP Transmission Control ProtocolTransmission Control Protocol (TCP)(TCP) and the and the Internet ProtocolInternet Protocol (IP)(IP)..

Page 9: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

DIVO Imaging devicesDIVO Imaging devices DIVO Multimedia static and motion video DIVO Multimedia static and motion video

capture/networking can be added to any capture/networking can be added to any imaging device, no matter how old or how imaging device, no matter how old or how new.new.

Page 10: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

DIVO Image ViewerDIVO Image Viewer Divo studies can be viewed on PCs or Macs and have various Divo studies can be viewed on PCs or Macs and have various

tools like zoom, brightness and contrast, scrolling video, tools like zoom, brightness and contrast, scrolling video, pause, double screen to view two or more movies at once, pause, double screen to view two or more movies at once, thumbnails, and can view pdf, docs, scanned in files etcthumbnails, and can view pdf, docs, scanned in files etc

Page 11: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

CONVENTIONAL DICOM PACS CONVENTIONAL DICOM PACS DISADVANTAGESDISADVANTAGES

DICOM image files are very large, making remote DICOM image files are very large, making remote access more time consuming and jerky, especially access more time consuming and jerky, especially with video.with video.

DICOM files have no doppler audio.DICOM files have no doppler audio. DICOM files have no triplex, scrolling M or doppler DICOM files have no triplex, scrolling M or doppler

modes.modes. DICOM video files have very limited duration.DICOM video files have very limited duration. DICOM files require application specific software for DICOM files require application specific software for

viewing.viewing. DICOM cannot incorporate standard computing DICOM cannot incorporate standard computing

programs like word, adobe and others or standard programs like word, adobe and others or standard computing hardware like scanners and printers.computing hardware like scanners and printers.

Video clip

3 sec

Video clip

3 sec

Video clip

3 sec

Video clip

3 sec

Video clip

3 sec

Page 12: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

DIVO PACS AdvantagesDIVO PACS Advantages Smaller file sizes transport much faster.Smaller file sizes transport much faster. Unlimited video lengths.Unlimited video lengths. Audio, triplex, scrolling doppler and m modeAudio, triplex, scrolling doppler and m mode Paper, PDF, DOC, TXT etc can be scanned Paper, PDF, DOC, TXT etc can be scanned

into patient file.into patient file. Instant retrieval of archived studies from Instant retrieval of archived studies from

LAN or WAN.LAN or WAN. Can be added to legacy equipment which Can be added to legacy equipment which

cannot upgrade to DICOM.cannot upgrade to DICOM. Can be viewed on any computer Mac or PCCan be viewed on any computer Mac or PC

Video clip

3 sec

Video clip

30 sec

Video clip

3 minutes

Video clip

30 minutes

Page 13: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

Installed baseInstalled base

Since 2005 Divo has been installed in Since 2005 Divo has been installed in over 180 locations including Guam, over 180 locations including Guam, Holland, Israel, Dubai and all over the Holland, Israel, Dubai and all over the USA.USA.

Page 14: (Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

A2D Imaging LLC A2D Imaging LLC

17271 Lido Lane17271 Lido Lane

Huntington Beach, Ca 92647Huntington Beach, Ca 92647

818 324 2871818 324 2871

www.a2dimaging.com www.a2dimaging.com