FujiFilm SonoSite Edge II User manual

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Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904
USA
Telephone: [phone] or 1-425-951-1200
Fax: [phone]
EC Authorized Representative
FujiFilm SonoSite B.V.
Joop Geesinkweg 140
1114 AB Amsterdam, The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Rd
Brookvale, New South Wales 2100, Australia
Edge, SiteLink, SonoCalc, SonoHD2, SonoMB, SonoMBe, SonoSite, and the SonoSite logo are registered (in some jurisdictions) and
unregistered trademarks owned by FUJIFILM SonoSite, Inc.
DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital
communications of medical information.
Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.
The SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents:
Patents: US 8,439,840; US 8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US 8,147,408; US 8,137,278; US 8,088,071; US 8,066,642;
US 8,052,606; US 7,819,807; US 7,804,970; US 7,740,586; US 7,686,766; US 7,604,596; US 7,591,786; US 7,588,541; US 7,534,211; US
7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,575,908; US 6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US
6,364,839; US 6,203,498; US 6,135,961; US 5,893,363 ; US 5,817,024; US 5,782,769; US 5,722,412; US 8,805,047; US 8,527,033; US
8,858,436; US 8,861,822; US 8,956,296; AU: 730822; AU: 727381; CA 2,372,152; CA: 2,371,711; CN 98108973.9; CN 98106133.8; CN
97113678.5; DE 69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE 602004023816.3; DE: 60034670.6; DE 60029777.2;
EP 1589878; EP 1552792; EP 1180971; EP 0875203; EP 0815793; EP 1180970; EP 0881492; ES 2229318; ES 159878; ES 1552792; ES
0881492; FR 158978; FR 1552792; FR 1180970; FR 0881492; FR 0875203; FR 0815793; GB 158978; GB 1552792; GB 1180971; GB 1180970;
GB 0881492; GB 0875203; GB 0815793; IT 1589878; IT 1552792; IT 0881492; IT 0815793; JP 4696150; KR 532359; KR 528102; NO 326814;
NO 326202 and pending.
P21828-02 10/2018
Copyright © 2018 FUJIFILM SonoSite, Inc.
All rights reserved.
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.

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Introduction.........................................................................1
Audience ..............................................................................................1
Contact Information..............................................................................1
Conventions, symbols, and terms ........................................................2
Labeling symbols..................................................................................2
Specifications .....................................................................7
Specifications .......................................................................................7
Dimensions...........................................................................................7
System .................................................................................................7
Display..................................................................................................7
Environmental limits .............................................................................7
Operating (system, battery, and transducer)........................................7
Shipping and storage (system and transducer)....................................7
Shipping and storage (battery).............................................................7
Electrical specifications ........................................................................7
Battery specifications ...........................................................................8
Compatible accessories and peripherals .............................................8
Safety...................................................................................11
Electrical safety ....................................................................................11
Electrical safety classification...............................................................13
Equipment safety..................................................................................13
Battery safety .......................................................................................14
Clinical safety .......................................................................................15
Hazardous materials ............................................................................15
Electromagnetic compatibility...............................................................16
Electrostatic discharge .........................................................................16
Separation distance..............................................................................17
Guidance and manufacturer’s declaration............................................18
Immunity testing requirements .............................................................21
Standards.............................................................................................21
Electrical safety standards ...................................................................21
EMC standards classification ...............................................................21
Acoustic standards...............................................................................21
Biocompatibility standards....................................................................21
Airborne equipment standards .............................................................22
DICOM standard ..................................................................................22
HIPAA standard....................................................................................22
System Overview................................................................23
About the System.................................................................................23
Theory of Operation .............................................................................24
Description of Operating Modes...........................................................25
Additional System Feature Performances............................................27
Front End Overview..............................................................................28
PW Doppler Processing .......................................................................30
CW Doppler Processing.......................................................................31
Back End Overview..............................................................................32
Control Subsystem...............................................................................33
Power Supply and Control....................................................................34