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

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ECG Module.........................................................................................36
DICOM .................................................................................................37
Troubleshooting .................................................................39
System and Subsystem Diagnosis.......................................................39
System Repair......................................................................................40
Test Equipment ....................................................................................40
Failure (Assert) Codes .........................................................................40
Verifying a System Assert Code...........................................................40
DICOM .................................................................................................42
Display..................................................................................................43
Battery..................................................................................................43
Control Panel........................................................................................43
Replacement Procedures ..................................................45
Display Replacement ...........................................................................45
Required Parts .....................................................................................45
Required Tools.....................................................................................45
Display Removal ..................................................................................45
Display Replacement ...........................................................................49
Test the Display....................................................................................49
Control Panel Subassembly Replacement...........................................49
Required Parts .....................................................................................50
Required Tools.....................................................................................50
Control Panel Removal ........................................................................51
Control Panel Replacement .................................................................51
TGC Assembly Removal......................................................................51
Main System Disassembly for Repair and/or Replacement .................52
Required Parts .....................................................................................52
Required Tools.....................................................................................52
System Disassembly............................................................................53
Speaker Replacement..........................................................................53
Required Part .......................................................................................53
Power Supply PCBA Replacement ......................................................55
Required Part .......................................................................................55
SD Card Replacement .........................................................................56
USB Extension PCB Assembly Replacement......................................56
Required Part .......................................................................................56
Main PCBA Replacement.....................................................................56
Required Parts .....................................................................................56
Midframe Replacement ........................................................................59
Required Parts .....................................................................................59
Bottom Enclosure Replacement...........................................................60
Required Parts .....................................................................................60
Maintenance........................................................................61
Periodic Maintenance...........................................................................61
Performance Testing..........................................................63
Overview ..............................................................................................63
Recommend Test Equipment...............................................................63
Setting Up Performance Tests .............................................................63

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Basic Operational Tests .......................................................................64
2D Performance Tests .........................................................................64
2D Performance / Image Quality..........................................................64
Axial Measurement Accuracy...............................................................65
Lateral Measurement Accuracy............................................................65
Penetration...........................................................................................66
Additional Performance Tests ..............................................................66
Color Doppler (Color) ...........................................................................66
Color Power Doppler (CPD) .................................................................67
M Mode Imaging...................................................................................67
Tissue Harmonic Imaging.....................................................................67
Image Quality Verification Test/Livescan .............................................67
Printer...................................................................................................68
Battery Charging ..................................................................................68
Video Output ........................................................................................68
Replacement Parts .............................................................69
Replacement Parts...............................................................................69
Display..................................................................................................69
Control Panel........................................................................................70
Main PCBA...........................................................................................71
Miscellaneous Parts .............................................................................73
Transducer Nest Frame Assembly.......................................................77
Ordering Replacement Parts................................................................78
Service Event Reporting ....................................................79
Service Event Report Form..................................................................80
Service Event Report Instructions........................................................81
Returning Products to SonoSite...........................................................82
Shipping Instructions............................................................................82

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Chapter 1: Introduction 1
Chapter 1: Introduction
Before servicing the SonoSite Edge II Ultrasound System, please read this manual.
The ultrasound system has multiple configurations and feature sets. All are described in this service manual
but not every option may apply to your system. System features depend on your system configuration,
transducer, and exam type.
Refer to the SonoSite Edge II Ultrasound System User Guide for additional information regarding safety,
system controls, operation, capabilities, and specifications.
This chapter also defines labeling symbols, specifications, and standards.
Audience
The intended audience of this manual is properly trained field and in-house service personnel.
Contact Information
Questions and comments are encouraged. SonoSite is interested in your feedback regarding the service
manual. If you encounter difficulty with the system, use the information in this manual to help correct the
problem. If the problem is not covered here, contact SonoSite Technical Support as follows:
Technical Support (USA, Canada) 1-877-657-8118
Technical Support fax: [phone]
Technical Support e-mail: [email protected]
SonoSite website: www.sonosite.com
International Technical Support: Contact your local representative or call (USA) [phone]
European Service Center United Kingdom
Tel: [phone]
e-mail: [email protected]
France
Tel: [phone]
e-mail: [email protected]
Germany
Tel: [phone]
e-mail: [email protected]
Spain
Tel: [phone]
e-mail: [email protected]
Italy
Tel [phone]
e-mail: [email protected]
Asia/Pacific Tel: [phone]
e-mail: FFSS-AP[email protected]

2Chapter 1: Introduction
Conventions, symbols, and terms
The user guide follows these conventions:
•A WARNING describes precautions necessary to prevent injury or loss of life.
•A Caution describes precautions necessary to protect the products.
• Numbered steps in procedures must be performed in order.
• Items in bulleted lists do not require performance in sequence.
Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 1: Labeling Symbols
Symbol Definition
Alternating Current (AC)
Class 1 device indicating manufacturer’s declaration of conformance with
Annex VII of 93/42/EEC
Class 1 device requiring verification by the Notified Body of sterilization or
measurement features, or to a Class IIa, IIb, or III device requiring
verification or auditing by the Notified Body to applicable Annex(es) of
93/42/EEC
Attention, see the user guide
Follow instructions for use.
Device complies with relevant Australian regulations for electronic devices.
Batch code, date code, or lot code type of control number
Biological risk
Device complies with relevant Brazilian regulations for electro-medical
devices.
Canadian Standards Association. The “C” and “US” indicators next to this
mark signify that the product has been evaluated to the applicable CSA
and ANSI/UL Standards, for use in Canada and the US, respectively.
Catalog number
Collect separately from other household waste (see European Commission
Directive 93/86/EEC). Refer to local regulations for disposal.
LOT
REF