Edge Service Manual P15644-02A e

Service Manual
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SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904
USA
Telephone: 1-888-482-9449 or 1-425-951-1200
Fax: 1-425-951-1201
SonoSite Ltd
Alexander House
40A Wilbury Way
Hitchin
Herts SG4 OAP
UK
T: +44-1462-444800
F: +44-1462-444801
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
Edge, SiteLink, SonoCalc, SonoHD2, SonoMB, SonoMBe, SonoSite, and the SonoSite logo are registered (in some jurisdictions) and unregistered
trademarks owned by 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:
55722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630,
6817982, 6835177, 6962566, 7169108, 7449640, 7534211, 7549961, 7588541, 7591786, 7604596, 7643040, 7686766, 7694814, 7727153, 7740586,
7804970, 7809400, 7819807, 7841575, 7849250, 7867168, 7883276, 7978461, 7996688, 8052606, 8066642, 8088071, 8090065, 8128050, 8137278,
8147408, 8164011, D456509, D461895, D509900, D538432, D544962, D558351, D559390, D591423, D592750, D592760, D625014, D625015, D657361,
and by the following counterpart foreign patents: AU727381, AU730822, CA2372152, CA2372158, CA2373065, CA 2371711, CN ZL 97113678.5, CN ZL
98106133.8, CN ZL 98108973.9, CN ZL 200830007734.8, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE69830539.6, DE69831698.3,
DE60200423816.3-08, DE 1589878, DE 1791086, ES2229318, ES2251057, ES2337140, FR0815793, FR0875203, FR0881492, FR1175713, FR1180970,
FR1589878, GB0875203, GB0881492, GB1175713, GB1180970, GB1180971, GB1589878, GB 1791086, IT0815793, IT0881492, IT1175713, JP 4696150,
KR528102, KR532359, NO326202, NO326814, NZ542968, RCD000897368-0001. Patents pending.
P15644-02 06/2012
Copyright 2012 by SonoSite, Inc.
All rights reserved.
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Table of Contents
Introduction ...................................................................................... 1
Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contact Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions, symbols, and terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Labeling symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Specifications.................................................................................... 5
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Environmental limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Battery specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Compatible accessories and peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Safety................................................................................................. 9
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Electrical safety classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Equipment safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Battery safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Clinical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Hazardous materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Electrostatic discharge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Separation distance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Guidance and manufacturer’s declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electrical safety standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
EMC standards classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Acoustic standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Biocompatibility standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Airborne equipment standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
DICOM standard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
HIPAA standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
System Overview .............................................................................. 21

About the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Description of Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Additional System Feature Performances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Front End Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
PW Doppler Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
CW Doppler Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Back End Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Control Subsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Power Supply and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
ECG Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
DICOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
IMT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
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Troubleshooting............................................................................... 35
System and Subsystem Diagnosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
System Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Test Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Failure (Assert) Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Verifying a System Assert Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
DICOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Replacement Procedures ................................................................. 39

Display Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Required Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Display Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Display Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Test the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Control Panel Subassembly Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Required Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Control Panel Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Control Panel Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Main System Disassembly for Repair and/or Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Required Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
System Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Speaker Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Required Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Power Supply PCBA Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Required Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
SD Card Daughter-card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Required Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
USB Extension PCB Assembly Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Required Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Main PCBA Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Middle Machined Enclosure Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Required Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Bottom Enclosure Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Required Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Maintenance ..................................................................................... 53
Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Cleaning and disinfecting the ultrasound system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Cleaning and disinfecting transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Cleaning and disinfecting the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Cleaning the footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Cleaning and disinfecting ECG cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Performance Testing ........................................................................ 59

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Recommend Test Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Setting Up Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Basic Operational Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
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2D Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
2D Performance / Image Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Axial Measurement Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Lateral Measurement Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Penetration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Additional Performance Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Color Doppler (Color). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Color Power Doppler (CPD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
M Mode Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Tissue Harmonic Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Pulsed Wave (PW) Doppler Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Continuous Wave (CW) Doppler Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Image Quality Verification Test/Livescan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Battery Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Video Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Replacement Parts............................................................................ 67
Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Main PCBA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Miscellaneous Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Transducer Nest Frame Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Ordering Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Service Event Reporting................................................................... 75

Service Event Report Form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Service Event Report Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Returning Products to SonoSite. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Shipping Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
vii
viii
Chapter 1: Introduction
Before servicing the Edge 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 Edge 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: 1-425-951-6700
Technical Support e-mail: service@sonosite.com
SonoSite website: www.sonosite.com (Select Resources > Support & Service)
International Technical Support: Contact your local representative or call (USA) +425-951-1330
European Service Center +44-(0)1462-444-800

e-mail: uk.service@sonosite.com
Japan Service Center +81-3-5304-5337
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.
Chapter 1: Introduction 1
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

LOT
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.
REF Catalog number
Collect separately from other household waste (see European Commission

Directive 93/86/EEC). Refer to local regulations for disposal.
Corrugated recycle
Dangerous voltage
Date of manufacture
2 Chapter 1: Introduction
Table 1: Labeling Symbols (Continued)
Symbol Definition
Manufacturer
Direct Current (DC)
Do not get wet.
Do not stack over 2 high.
Electrostatic sensitive devices
Device complies with relevant FCC regulations for electronic devices.
Fragile
GEL Gel
Sterilized using irradiation

STERILE R
STERILE EO Sterilized using ethylene oxide
Hot
Device emits a static (DC) magnetic field.
Non-ionizing radiation
Paper recycle
Chapter 1: Introduction 3
Table 1: Labeling Symbols (Continued)
Symbol Definition
SN Serial number type of control number
Temperature limitation
Atmospheric pressure limitation
Humidity limitation
Submersible. Protected against the effects of temporary immersion.
Water-Tight Equipment. Protected against the effects of extended immersion.
Handle transducer with care.
Follow manufacturer’s instructions for disinfecting time.
Disinfect transducer.
Type BF patient applied part

(B = body, F = floating applied part)
Defibrillator proof type CF patient applied part
Underwriter’s Laboratories labeling
Pollution Control Logo. (Applies to all parts/products listed in the China RoHS
disclosure table. May not appear on the exterior of some parts/products because of
space limitations.)
China Compulsory Certificate mark (“CCC Mark”). A compulsory safety mark for
compliance to Chinese national standards for many products sold in the People’s
Republic of China.
WARNING: WARNING: Connect Only
Connect Only
Accessories and Peripherals
Accessories and
Peripherals Recommended by SonoSite
Recommended by
SonoSite
4 Chapter 1: Introduction
Chapter 2: Specifications
This chapter contains information regarding system specifications and accessory compatibility. The information
applies to the ultrasound system, transducers, accessories, and peripherals.
Specifications
Dimensions
System
• Length: 13 in. (33 cm)
• Width: 12.4 in. (31.5 cm)
• Height: 2.5 in. (6.3 cm)
Display
• Length: 9.7 in. (24.6 cm)
• Height: 7.3 in. (18.5 cm)
• Diagonal: 12.1 in. (30.7 cm)
Environmental limits
Note: The temperature, pressure, and humidity limits apply only to the ultrasound system, transducers, and battery.
Operating (system, battery, and transducer)

10–40°C (50–104°F), 15–95% R.H.
700 to 1060hPa (0.7 to 1.05 ATM)
Mode of Operation:
Continuous 35°C or below
Non-Continuous above 35°C (30 minutes on /30 minutes off)
Shipping and storage (system and transducer)

-35–65°C (-31–149°F), 15–95% R.H.
500 to 1060hPa (0.5 to 1.05 ATM)
Shipping and storage (battery)

-20–60°C (-4–140°F), 15–95% R.H. (For storage longer than 30 days, store at or below room temperature.)
500 to 1060hPa (0.5 to 1.05 ATM)
Electrical specifications
Power Supply Input: 100-240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC
Power Supply Output #1: 15 VDC, 5.0 A Max
Power Supply Output #2: 12 VDC, 2.3 A Max
Combined output not exceeding 75 watts.
Chapter 2: Specifications 5
Battery specifications
The battery is comprised of six lithium-ion cells plus electronics, a temperature sensor, and battery contacts.
Run time is up to two hours, depending on imaging mode and display brightness. This chapter contains electrical, and
clinical safety information required by regulatory agencies. The information applies to the ultrasound system,
transducer, accessories, and peripherals.
Compatible accessories and peripherals

SonoSite has tested the Edge ultrasound system with the following accessories and peripherals and has demonstrated
compliance to the requirements of IEC60601-1-2:2007.
You may use these SonoSite accessories and third-party peripherals with the Edge ultrasound system.
WARNING: Use of the accessories with medical systems other than the Edge ultrasound
system may result in increased emissions or decreased immunity of the medical
system.
WARNING: Use of accessories other than those specified may result in increased emissions or
decreased immunity of the ultrasound system.
Accessories and peripherals compatible with Edge ultrasound system
Description Part Number Maximum Cable Length
C8 transducer P08010 6.0 ft/1.8 m
C11x transducer P07678 6.5 ft/2.0 m
C60x transducer P07680 6.0 ft/1.8 m
D2x transducer P05165 6.0 ft/1.8 m
HFL38x transducer P07682 6.0 ft/1.8 m
HFL50x transducer P07693 6.0 ft/1.8 m
ICTx transducer P07690 6.0 ft/1.8 m
L25x transducer P07691 8.0 ft/2.4 m
L38xi transducer P12742 6.0 ft/1.8 m
L52x transducer (Vet) V00033 7.9 ft/2.4 m
P10x transducer P07696 6.5 ft/2.0 m
P21x Transducer P07698 6.5 ft/2.0 m
SLAx transducer P07699 8.0 ft/2.4 m
TEEx Transducer P05183 7.5 ft/2.3 m
Bar code scanner P14166 4.8 ft/1.5 m
Battery for PowerPack P13123 —
Battery Pack P15051 —
PowerPack P13122 —
Black & white printer P13745 —
6 Chapter 2: Specifications
Accessories and peripherals compatible with Edge ultrasound system (Continued)
Black & white printer power — 3.3 ft/1 m

cable
Black & white printer USB — 10.8 ft/3.3 m

cable
Color printer P13983 —
Color printer power cable — 3.3 ft/1 m
Color printer video cable — 6.0 ft/ 1.8 m
ECG lead wires P14202 24 in/ 0.6 m
ECG module P08501 5.8 ft/1.8 m
Edge Dock P15078 —
Edge Stand P15800 —
Footswitch P14689 9.8 ft/3.0 m
Petite mouse P14451 6 ft /1.8 m
Power cord (system) P00848 (USA) 10 ft/3 m
Power Supply/Battery Charger P09823 6.8 ft/ 2 m
PowerPark P12822 —
Triple Transducer Connect P15922 —
USB wireless adapter P12046 —
Chapter 2: Specifications 7
8 Chapter 2: Specifications
Chapter 3: Safety
This chapter contains electrical and clinical safety information required by regulatory agencies. The information
applies to the ultrasound system, transducers, accessories, and peripherals.
Electrical safety
This system meets EN60601-1, Class I/internally-powered equipment requirements and Type BF and Type CF isolated
patient-applied parts safety requirements.
This system complies with the applicable medical equipment requirements published in the Canadian Standards
Association (CSA), European Norm Harmonized Standards, and Underwriters Laboratories (UL) safety standards. See
“Standards” on page 19.
For maximum safety observe the following warnings and cautions.
WARNING: To avoid the risk of injury, do not operate the system in the presence of flammable
gasses or anesthetics. Explosion can result.
WARNING: To avoid the risk of electrical shock or injury, do not open the system enclosures. All
internal adjustments and replacements, except battery replacement, must be made by a
qualified technician.
WARNING: To avoid the risk of electrical shock:
• This equipment must be connected only to a supply mains with protective earth.
• Use only properly grounded equipment. Shock hazards exist if the power supply is
not properly grounded. Grounding reliability can be achieved only when equipment
is connected to a receptacle marked “Hospital Only” or “Hospital Grade” or
equivalent. The grounding wire must not be removed or defeated.
• When using the system in an environment where the integrity of the protective earth
conductor arrangement is in doubt, operate the system on battery power only and
disconnect the power supply.
• Do not let the bar code scanner or external mouse touch the patient.
• Do not touch any of the following:
• The power supply and the patient at the same time
• The ungrounded signal input/output connectors on the back of the ultrasound
system
• The system battery contacts (inside the battery compartment)
• The system transducer connector when the transducer or Triple Transducer
Connect (TTC) is disconnected
• The system transducer connector on the TTC if no transducers are connected
• Do not connect the system power supply or docking system to a multiple portable
socket outlet (MPSO) or extension cord.
• Before using the transducer, inspect the transducer face, housing, and cable. Do not use
the transducer if the transducer or cable is damaged.
• Always disconnect the power supply from the system before cleaning the system.
• Do not use any transducer that has been immersed beyond the specified cleaning or
disinfection level. See Chapter 7, “Maintenance”
• Use only accessories and peripherals recommended by SonoSite, including the power
supply. Connection of accessories and peripherals not recommended by SonoSite
could result in electrical shock. Contact SonoSite or your local representative for a list
of accessories and peripherals available from or recommended by SonoSite.
Chapter 3: Safety 9
WARNING: To avoid the risk of electrical shock and fire hazard:
• Inspect the power supply, AC power cords, cables, and plugs on a regular basis.
Ensure that they are not damaged.
• The power cord set that connects the power supply of the ultrasound system or the
stand to mains power must only be used with the power supply or docking system,
and cannot be used to connect other devices to mains power.
WARNING: To prevent injury to the operator/bystander, the transducer must be removed from
patient contact before the application of a high-voltage defibrillation pulse.
WARNING: To avoid possible electrical shock or electromagnetic interference, verify proper
operation and compliance with relevant safety standards for all equipment before
clinical use. Connecting additional equipment to the ultrasound system constitutes
configuring a medical system. SonoSite recommends verifying that the system, all
combinations of equipment, and accessories connected to the ultrasound system
comply with JACHO installation requirements and/or safety standards such as
AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and electromagnetic compatibility
standard IEC 60601-1-2 (Electromagnetic compatibility), and are certified according to
IEC Standard 60950 (Information Technology Equipment (ITE)).
Caution: Do not use the system if an error message appears on the image display: note the error
code; call SonoSite or your local representative; turn off the system by pressing and
holding the power key until the system powers down.
Caution: To avoid increasing the system and transducer connector temperature, do not block the
airflow to the ventilation holes on the side of the system.
10 Chapter 3: Safety
Electrical safety classification
Class I equipment The ultrasound system is classified as Class I equipment when

powered from the external power supply or mounted on the stand
because the external power supply is a Class 1 protectively
earthed power supply.
The stand has no protective earth. Ground bond testing is not
applicable to the ultrasound system or the stand.
Note: AC powered peripherals that may be used with the system are Class
I and are individually protectively earthed. Ground bond testing may be
conducted on each AC powered peripheral.
Internally powered equipment Ultrasound system not connected to the power supply (battery
only)
Type BF applied parts Ultrasound transducers
Type CF applied parts ECG module/ECG leads
IPX-7 (watertight equipment) Ultrasound transducers
IPX-8 (watertight equipment) Footswitch
Non AP/APG Ultrasound system power supply, docking system, and

peripherals. Equipment is not suitable for use in the presence of
flammable anaesthetics.
Equipment safety
To protect your ultrasound system, transducers, and accessories, follow these precautions.
Caution: Excessive bending or twisting of cables can cause a failure or intermittent operation.
Caution: Improper cleaning or disinfecting of any part of the system can cause permanent
damage. For cleaning and disinfecting instructions, see Chapter 7, “Maintenance.”
Caution: Do not submerge the transducer connector in solution. The cable is not liquid-tight
beyond the transducer connector/cable interface.
Caution: Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the
system.
Caution: Remove the battery from the system if the system is not likely to be used for some time.
Caution: Do not spill liquid on the system.
Chapter 3: Safety 11
Battery safety
To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury or equipment damage,
observe the following precautions.
WARNING: The battery has a safety device. Do not disassemble or alter the battery.
WARNING: Charge the batteries only when the ambient temperature is between 0° and 40°C (32°
and 104°F).
WARNING: Do not short-circuit the battery by directly connecting the positive and negative
terminals with metal objects.
WARNING: Do not touch battery contacts.
WARNING: Do not heat the battery or discard it in a fire.
WARNING: Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire
and other heat sources.
WARNING: Do not charge the battery near a heat source, such as a fire or heater.
WARNING: Do not leave the battery in direct sunlight.
WARNING: Do not pierce the battery with a sharp object, hit it, or step on it.
WARNING: Do not use a damaged battery.
WARNING: Do not solder a battery.
WARNING: The polarity of the battery terminals are fixed and cannot be switched or reversed. Do
not force the battery into the system.
WARNING: Do not connect the battery to an electrical power outlet.
WARNING: Do not continue recharging the battery if it does not recharge after two successive six
hour charging cycles.
WARNING: Do not ship a damaged battery without instructions from SonoSite Technical Support.
(See “Technical Support (USA, Canada)” on page 1.)
WARNING: If the battery leaks or emits an odor, remove it from all possible flammable sources.
WARNING: Periodically check to make sure that the battery charges fully. If the battery fails to
charge fully, replace it.
Caution: To avoid the battery becoming damaged and causing equipment damage, observe the
following precautions:
• Do not immerse the battery in water or allow it to get wet.
• Do not put the battery into a microwave oven or pressurized container.
• If the battery emits an odor or heat, is deformed or discolored, or in any way appears
abnormal during use, recharging or storage, immediately remove it and stop using it.
If you have any questions about the battery, consult SonoSite or your local
representative.
• Store the battery between -20°C (-4°F) and 60°C (140°F).
• Use only SonoSite batteries.
• Do not use or charge the battery with non-SonoSite equipment. Only charge the battery
with the system.
Clinical safety
WARNING: Non-medical (commercial) grade peripheral monitors have not been verified or
validated by SonoSite as being suitable for diagnosis.
WARNING: To avoid the risk of a burn hazard, do not use the transducer with high frequency
surgical equipment. Such a hazard may occur in the event of a defect in the high
frequency surgical neutral electrode connection.
WARNING: Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in
the scanning sequence are indicative of a hardware failure that must be corrected before
use.
WARNING: Some transducer sheaths contain natural rubber latex and talc, which can cause allergic
reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that
contain natural rubber.
WARNING: Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably
achievable) principle and follow the prudent use information concerning MI and TI.
WARNING: SonoSite does not currently recommend a specific brand of acoustic standoff. If an
acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz.
WARNING: Some SonoSite transducers are approved for intraoperative applications if a
market-cleared sheath is used.
WARNING: To avoid injury or reduce the risk of infection to the patient, observe the following:
• Follow Universal Precautions when inserting and maintaining a medical device for
interventional and intraoperative procedures.
• Appropriate training in interventional and intraoperative procedures as dictated by
current relevant medical practices as well as in proper operation of the ultrasound
system and transducer is required. During vascular access, the potential exists for
serious complications including without limitation the following: pneumothorax,
arterial puncture, guidewire misplacement, and risks normally associated with local
or general anesthesia, surgery, and post-operative recovery.
WARNING: To avoid device damage or patient injury, do not use the P10x, P17x, or P21x needle
guide bracket on patients with pacemakers or medical electronic implants. The needle
guide bracket for the P10x, P17x, and P21x transducers contains a magnet that is used
to ensure the bracket is correctly oriented on the transducer. The magnetic field in
direct proximity to the pacemaker or medical electronic implant may have an adverse
effect.
Hazardous materials
WARNING: Products and accessories may contain hazardous materials. Ensure that products and
accessories are disposed of in an environmentally responsible manner and meet federal
and local regulations for disposing hazardous materials.
WARNING: The liquid crystal display (LCD) contains mercury. Dispose of the LCD properly in
accordance with local regulations.
Electromagnetic compatibility
The ultrasound system has been tested and found to comply with the electromagnetic compatibility (EMC) limits for
medical devices to IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
WARNING: The Edge ultrasound system should not be used adjacent to or stacked with other
equipment. If such use occurs, verify that the Edge ultrasound system operates
normally in that configuration.
Caution: Medical electrical equipment requires special precautions regarding EMC and must be
installed and operated according to these instructions. Portable and mobile RF
communications equipment can affect the ultrasound system. Electromagnetic
interference (EMI) from other equipment or interference sources could result in
performance disruption of the ultrasound system. Evidence of disruption may include
image degradation or distortion, erratic readings, equipment ceasing to operate, or other
incorrect functioning. If this occurs, survey the site to determine the source of
disruption, and take the following actions to eliminate the source(s).
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or re-orient interfering equipment.
• Increase distance between interfering equipment and your ultrasound system.
• Manage use of frequencies close to ultrasound system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within facility control (such as paging systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in areas with
devices susceptible to EMI.
• Share relevant EMI information with others, particularly when evaluating new
equipment purchases which may generate EMI.
• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
Caution: To avoid the risk of increased electromagnetic emissions or decreased immunity, use
only accessories and peripherals recommended by SonoSite. Connection of accessories
and peripherals not recommended by SonoSite to the ultrasound system may result in
malfunction of the ultrasound system or other medical electrical devices in the area.
Contact SonoSite or your local representative for a list of accessories and peripherals
available from or recommended by SonoSite. See the SonoSite accessories user guide.
Electrostatic discharge
Caution: Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon.
ESD is common in conditions of low humidity, which can be caused by heating or air
conditioning. ESD is a discharge of the electrical energy from a charged body to a
lesser or non-charged body. The degree of discharge can be significant enough to cause
damage to a transducer or an ultrasound system. The following precautions can help
reduce ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static
mats.
Separation distance
Recommended separation distances between portable and mobile RF communications equipment and the
Edge ultrasound system
The Edge ultrasound system is intended for use in an electromagnetic environment in which
radiated radio frequency (RF) disturbances are controlled. The customer or the user of the Edge
ultrasound system can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Edge
ultrasound system as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter

Rated maximum m
output power of
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Watts
d=1.2 P d=1.2 P d=2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Guidance and manufacturer’s declaration
WARNING: Other equipment, even equipment that complies with CISPR emission requirements,
can interfere with the Edge ultrasound system.
The Edge ultrasound system contains an IEEE 802.11 transmitter that utilizes the ISM frequency band from 2.412 to
2.4835 GHz and implements two methods of transmission:
• IEEE 802.11b with Complementary Code Keying (CCK), Differential Quaternary Phase Shift Keying (DQPSK),
and Differential Binary Phase Shift Keying (DBPSK) at 16 dB
• IEEE 802.11g with Orthogonal Frequency Division Multiplexing (OFDM) at 13 dBm
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The Edge ultrasound system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Edge ultrasound system should assure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic Environment
RF emissions Group 1 The Edge ultrasound system uses RF energy only for
ClSPR 11 its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class A The Edge ultrasound system is suitable for use in all
ClSPR 11 establishments other than domestic and those directly
connected to the public low-voltage power supply
Harmonic emissions Class A network which supplies buildings used for domestic
IEC 61000-3-2 purposes.±
Voltage Complies
fluctuations/flicker
emissions
IEC 61000-3-3
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
environment.
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment
Electrostatic ±6.0KV contact ±6.0KV contact Floors should be wood,

Discharge ±8.0KV air ±8.0KV air concrete or ceramic tile. If
(ESD) floors are covered with
IEC 61000-4-2 synthetic material, the relative
humidity should be at least
30%.
Electrical fast ±2KV for power ±2KV for power Mains power quality should be
Transient burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ±1KV for input/output ±1KV for hospital environment.
lines input/output lines
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
environment.
Electromagnetic
Environment
Surge ±1KV line(s) to line(s) ±1KV line(s) to Mains power quality should be
IEC 61000-4-5 ±2KV line(s) to earth line(s) that of a typical commercial or
±2KV line(s) to hospital environment.
earth
Voltage dips, >5% UT >5% UT Mains power quality should be

short (>95% dip in UT) for (>95% dip in UT) that of a typical commercial or
interruptions hospital environment. If the
0.5 cycle for 0.5 cycle
and voltage user of the Edge ultrasound
variations on 40% UT 40% UT system requires continued
power supply (60% dip in UT) for 5 (60% dip in UT) for operation during power mains
input lines cycles 5 cycles interruptions, it is
IEC 61000-4-11 70% UT 70% UT recommended that the Edge
ultrasound system be powered
(30% dip in UT) for 25 (30% dip in UT) for from an uninterruptible power
cycles 25 cycles supply or a battery.
>5% UT >5% UT
(>95% dip in UT) for (>95% dip in UT)
5s for 5s
Power 3 A/m 3 A/m Power frequency magnetic

Frequency fields should be at levels
Magnetic Field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF

IEC 61000-4-6 150 kHz to 80 MHz communications equipment
should be used no closer to any
part of the Edge ultrasound
system including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended Separation
Distance
d = 1.2 P
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
environment.
Electromagnetic
Environment
Radiated RF 3 Vim 3 V/m d = 1.2 P

IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Radiated RF Field strengths from fixed RF

IEC 61000-4-3 transmitters, as determined by
(continued) an electromagnetic Site
surveya, should be less than the
compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Note: UT is the AC mains voltage prior to application of the test level.

At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the SonoSite ultrasound system is used exceeds the applicable RF compliance
level above, the SonoSite ultrasound system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause undesired operation.
Immunity testing requirements
The Edge ultrasound system complies with the essential performance requirements specified in IEC 60601-1-2 and
IEC 60601-2-37. Results of immunity testing show that the Edge ultrasound system meets these requirements and is
free from the following:
• Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that cannot be
attributed to a physiological effect and that may alter the diagnosis
• Display of incorrect numerical values associated with the diagnosis to be performed
• Display of incorrect safety related indications
• Production of unintended or excessive ultrasound output
• Production of unintended or excessive transducer assembly surface temperature
• Production of unintended or uncontrolled motion of transducer assemblies intended for intra-corporeal use
Standards
Electrical safety standards
AAMI/ANSI ES 60601-1:2005, Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and
Essential Performance.
CAN/CSA C22.2, No. 60601-1, Canadian Standards Association, Medical Electrical Equipment—Part 1. General
Requirements for Safety.
CAN/CSA C22.2, No. 60601-1:08, Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and
Essential Performance.
IEC 60601-1:1988, International Electrotechnical Commission, Medical Electrical Equipment—Part 1. General
Requirements for Safety.
IEC 60601-1:2005, Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential
Performance.
IEC 60601-1-1:2000, Medical Electrical Equipment—Part 1-1. General Requirements for Safety-Section 1-1.
Collateral Standard. Safety Requirements for Medical Electrical Systems.
IEC 60601-2-37:2001, International Electrotechnical Commission, Particular Requirements for the Safety of
Ultrasonic Medical Diagnostic and Monitoring Equipment.
IEC 60601-2-37:2007, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and
Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment.
IEC 61157, International Electrotechnical Commission, Standard Means for the Reporting of the Acoustic Output of
Medical Diagnostic Ultrasonic Equipment.
EMC standards classification

CISPR 11, International Electrotechnical Commission, International Special Committee on Radio Interference.
Industrial, Scientific, and Medical (ISM) Equipment—Radio-Frequency Disturbance Characteristics—Limits and
Methods of Measurement. Classification for the ultrasound system, docking system, accessories, and peripherals when
configured together: Group 1, Class A.
IEC 60601-1-2:2007, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral
Standard: Electromagnetic Compatibility—Requirements and Tests.
Acoustic standards
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
NEMA UD 3-2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine.
Biocompatibility standards
AAMI/ANSI/ISO 10993-1, Biological evaluation of medical devices—Part 1: Evaluation and testing (2009).
AAMI/ANSI/ISO 10993-5, Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity (2009).
AAMI/ANSI/ISO 10993-10, Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type
hypersensitivity (2002).
AAMI/ANSI/ISO 10993-11, Biological evaluation of medical devices—Part 11: Tests for systemic toxicity (2006).
AAMI/ANSI/ISO 10993-12, Biological evaluation of medical devices—Part 12: Sample preparation and reference
materials (2007).
Airborne equipment standards

RTCA DO-160E, Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for
Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B. 118.
DICOM standard
NEMA PS 3.15, Digital Imaging and Communications in Medicine (DICOM)—Part 15: Security and System
Management Profiles.
HIPAA standard
Health Insurance and Portability and Accountability Act, Pub.L. No. 104-191.
45 CFR 160, General Administrative Requirements.
45 CFR 164, Security and Privacy.
Chapter 4: System Overview
About the System

The SonoSite Edge high-resolution ultrasound system is a portable, full featured, general purpose, software
controlled, diagnostic ultrasound system using all digital architecture. The system is used to acquire and display
high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW)
Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes.
The system has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect
data for M Mode and Doppler measurements. The system provides measurement capabilities for anatomical
structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW
and CW Doppler audio output feature, cine review, image zoom, labeling, biopsy, measurements and calculations,
image storage and review, printing, and recording capabilities.
The system includes the optional ability to measure the intima-media thickness (IMT) of the carotid artery using
digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical
data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes optional Digital Imaging and Communications (DICOM) capabilities as well as general
computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing
of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode
combinations. The system displays the current output level in terms of one of two bioeffects indices (“Mechanical
Index [MI]” and “Thermal Index [TI]”) in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal
and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.
Chapter 4: System Overview 21

Theory of Operation
The Edge ultrasound system has seven (7) major functional groups:
• Transducer
• Acquisition Subsystem
• Processing Subsystem
• Display Subsystem
• Control Subsystem
• User Interface Subsystem
• Power Subsystem
is a system block diagram that shows the relationship of the functional groups.
External video to monitor,

printer
Acquisition RF Bus Processing AQ Bus Display
subsystem subsystem subsystem Video
User
interface
IrDA
Control
subsystem Serial Bus
Control Bus
Power
subsystem
Battery
pack
Display power assembly
Transducer
Logic power
Pulser voltage
Power
adapter
External power
Figure 4.1 SonoSite Edge High-Resolution Ultrasound System Block Diagram
The Transducer elements convert the pulser voltage to acoustic energy during the transmit portion of the
ultrasound acquisition cycle. The elements convert the acoustic echo to voltage in the receive portion of the
acquisition. The voltage developed on the transducer elements is sensed by the acquisition subsystem. The system
transducers have 64 to 192 elements.
The Acquisition Subsystem consists of the beamformer and interface to the transducer. The beamformer controls
the timing of the transmit pulses to focus the acoustic beam. The beamformer amplifies the low-level received
echos and controls the receive focusing. The system beamformer transmits on up to 128 elements and receives on
64 elements.
The Processing Subsystem includes capabilities for interfacing with the beamformer and performing high speed
processing. The processing subsystem demodulates, filters, detects, and compresses the signal supplied by the
beamformer into display information.
22 Chapter 4: System Overview

The Display Subsystem converts the detected ultrasound data into picture elements (pixels). The software user
interface graphics are combined with the ultrasound information and converted to a video stream. The external
video port supports NTSC and PAL format.
The Control Subsystem consists of the central processing unit, program and video memory, permanent image
storage and retrieval memory, external communication interface ports, and connection to the user interface keys.
The control software includes the acoustic power and intensity software subsystem, power group monitors, and a
beamformer monitor. This software guarantees a level of patient safety by ensuring the system is operating within
acoustic power and intensity limits.
The User Interface Subsystem represents the software interface and form factor. The software interface is the
interaction between the user and the screen layout components. The form factor is the type of physical buttons,
location, and grouping of the buttons and the device size, shape, and weight. Dedicated controls are for high usage
activities and grouped according to the user workflow.
The Power Subsystem provides the system power and protects the hardware from destructive and/or unsafe
conditions by detecting failures in the system through hardware and software monitors. Detection of a fault results
in disabling of the pulser supply, and signaling of an error to the Control Group. The power subsystem includes the
battery pack and battery charging electronics.
Description of Operating Modes
2D Mode 2D mode is a two dimensional image of the amplitude of the echo signal. It is used for
location and measurement of anatomical structures and for spatial orientation during
operation of other modes. In 2D, a two-dimensional cross-section of a 3-dimensional soft
tissue structure such as the heart is displayed in real time. Ultrasound echoes of different
intensities are mapped to different gray scale or color values in the display. The outline of the
2D cross-section may be a rectangle, parallelogram, trapezoid, sector, or a full circle,
depending on the particular transducer used. 2D mode can be used in combination with any
other modes.
M Mode M Mode is also known as “T-M mode” or “time-motion” mode. It is used primarily for cardiac
measurements such as valve timing and septal wall thickness when accurate timing
information is required.
Ultrasound echoes of different intensities are mapped to different gray scale values in a
scrolling display. M Mode displays time motion information of the ultrasound data derived
from a stationary beam. Depth is arranged along the vertical axis with time along the
horizontal axis. M Mode can be used alone but is normally used in conjunction with a 2D
image for spatial reference. The 2D image has a graphical line (M-line) superimposed on the
2D image indicating where the M Mode beam is located.

Color In color Doppler, a real-time, two-dimensional cross-section of blood flow is displayed. The
Doppler 2D cross-section may be presented as a rectangle, parallelogram, trapezoid, sector, or a full
(Color) circle, depending on the particular transducer used.
The 2D cross-section is presented as a full color display, with various colors being used to
represent the velocity, both positive and negative, of the blood flow echoes. Often, to
provide spatial orientation, the full color blood flow cross-section is overlaid on top of the
gray scale cross-section of soft tissue structure (2D echo). For each pixel in the overlay, the
decision of whether to display VCD, gray scale (echo) information or a blended combination
is based on the relative strength of echoes from the soft-tissue structures and from the red
blood cells.
A high pass filter (wall filter) is used to remove the signals from stationary or slowly moving
structures. Tissue motion is discriminated from blood flow by assuming that blood is moving
faster than the surrounding tissue, although additional parameters may also be used to
enhance the discrimination. The remaining signal after wall filtering may be averaged over
time (persistence) to present a steady state image of blood flow distribution. Variance
information may also be displayed to provide information when large variance is observed in
the velocity information.
Color Power In CPD, a real-time two-dimensional cross-section of blood flow is displayed. The 2D
Doppler cross-section may be presented as a rectangle, parallelogram, trapezoid, sector, or a full
(CPD) circle, depending on the particular transducer used.
The 2D cross-section is presented as a full color display, with various colors being used to
represent the power in blood flow echoes. Often, to provide spatial orientation, the full color
blood flow cross-section is overlaid on top of the gray scale cross-section of soft tissue
structure (2D echo). For each pixel in the overlay, the decision of whether to display CPD, gray
scale (echo) information or a blended combination is based on the relative strength of
echoes from the soft-tissue structures and from the red blood cells.
A high pass filter (wall filter) is used to remove the signals from stationary or slowly moving
structures. Tissue motion is discriminated from blood flow by assuming that blood is moving
faster than the surrounding tissue, although additional parameters may also be used to
enhance the discrimination. The power in the remaining signal after wall filtering may be
averaged over time (persistence) to present a steady state image of blood flow distribution.
Continuous CW provides a real-time representation of blood flow and is displayed as a

Wave (CW) velocity-versus-time sweeping output. Velocity (or frequency) is presented as the vertical
Doppler axis with time along the horizontal axis. The magnitude of the detected signal is represented
as different gray scale values.
CW Doppler mode provides the clinician with the ability to obtain blood flow velocities
focused about a user specified focal region. A continuous transmit waveform of ultrasound
energy with a known frequency is transmitted and focused by the system; on the receive
side, the transducer receive echoes are continuously amplified, focused about the focal
region and converted to a base band quadrature signal. The signal is analyzed by a
quadrature phase detector that establishes two receive channels to allow detection of flow
direction. These two channels are then analyzed by a fast complex Fourier transform (FFT)
circuit to establish the spectrum of frequencies present in the echoes. The data are displayed
as spectrum frequencies with respect to time.
CW can be used alone but is normally used in conjunction with a 2D image for spatial
reference. The 2D image has a graphical line (D-line) superimposed on the 2D image
indicating where the M-mode beam is located.

Pulsed Wave PW provides a real-time representation of blood flow and is displayed as a
(PW) Doppler velocity-versus-time sweeping output. Velocity (or frequency) is presented as the vertical
axis with time along the horizontal axis. The magnitude of the detected signal is represented
as different gray scale values. The ultrasound data is derived from a single area, the sample
volume, on a stationary beam.
PW Doppler mode provides the clinician with the ability to obtain blood flow velocities
about a spatial sample volume. A burst of ultrasound with a known spectrum is transmitted
by the system; on the receive side, the transducer receive echoes are amplified and range
gated at the appropriate depth. The signal is analyzed by a quadrature phase detector that
establishes two receive channels to allow detection of flow direction. These two channels are
then analyzed by a fast complex Fourier transform (FFT) circuit to establish the spectrum of
frequencies present in the echoes. The data are displayed as spectrum frequencies with
respect to time.
PW can be used alone but is normally used in conjunction with a 2D image for spatial
reference. The 2D image has a graphical line (D-line) superimposed on the 2D image
indicating where the M-mode beam is located. The sample volume position (depth) and size
are also indicated on the D-Line.
Additional System Feature Performances
Broadband Imaging This ultrasound acquisition system uses high resolution broadband technology in
the transmit pulsers, transducer, and receivers. The receive path can capture and
process signals over a wide spectrum, from below 2.0 MHz to beyond 10 MHz. For
each application, the transmit pulse is designed to produce an appropriate
bandwidth. For example, in 2D grayscale imaging, a wide band pulse is used to
support good axial resolution. For Doppler modes, a narrower band pulse is used,
which improves the spectral resolution of the detected Doppler signal.
In addition to transmit pulse control, programmable digital signal processing is used
in the receive path to further refine the bandwidth used to produce the final image.
Digital filters are applied to the digitized received signal to limit and shape the
spectral bandwidth used to generate the displayed output.
Tissue Specific In this feature, parameters for signal and image processing are optimized to
Imaging maximize the image quality or to obtain the best compromise of resolution and
penetration for different specific clinical applications. These parameters include: the
order of received filters, the bandwidth, the dynamic range, the compression curve,
the gain setting and parameters for compounding frequency band, etc. For
example, different system parameter setups are used for abdominal or peritoneal
scanning. This feature is for ease of use for the operator by automatically setting up
system control parameters rather than manually adjusting settings for best
performance.
Biopsy Guidance The system can display a pair of biopsy guidelines that represent the anticipated
path of the biopsy needle. The image of an anatomical target, biopsy guidelines, a
scan plane marker, and a biopsy needle are displayed to assist in guiding the biopsy
needle to the target. The system also provides needle guidance for vascular access
procedures. For additional information, see the biopsy user guides.
Measurement and The system offers a variety of measurements and calculations, specific to exam type
Calculation and transducer. A list of them, and author references, are in the system user guide.
Capabilities Measurement accuracy is also discussed.

Continuous Wave The system provides for audio output of the CW velocity information. This can be
Doppler Audio presented as stereo information, with flow moving towards the transducer on one
Output channel and flow away on the other, or as a mono output with the single audio
output representing the summation of the flow directions.
Pulsed Wave Doppler The system provides for audio output of the PW velocity information. This can be
Audio Output presented as stereo information, with flow moving towards the transducer on one
channel and flow away on the other, or as a mono output with the single audio
output representing the summation of the flow directions.
Electrocardiograph ECG is provided to measure the electrical signal generated by the heart. A three lead
(ECG) Display interface: Right Arm (RA), Left Arm (LA) and Left Leg (LL), is provided on the system.
The ECG signal is displayed as an amplitude-versus-time sweeping output.
Amplitude is presented on the vertical axis with time along the horizontal axis.
Front End Overview

The Front End is designed to support various imaging modalities such as 2D, M-Mode, Spectral Doppler and Color
Doppler. From the Front End's perspective, all modes can be grouped into a few basic types: Single mode,
simultaneous modes and triggered modes. All these modes are built from similar, basic transmit and receive
sequences controlled within the Front End. A generic top level block diagram of a typical Front End is in the figure
below.
Transducer Receive Section

T/R Sw
A/D Delay X
TGC Amplifier Weight
Beamformed
Pulser Delay Data
Waveform
T/R Sw
A/D Delay X
TGC Amplifier Weight
Pulser Delay
Waveform Control
Transmit Section
Figure 4.2 Front End Block Diagram
The transmit section consists of a waveform generator, delay block, and high power high voltage driver to excite
the transducer element. Multiple elements are driven with delays determined by the time of flight in the medium
from the elements to the point in space where the beam is to be focused. The longer the time of flight is to the focal
point the smaller the delay is for a given transmit element to allow all to arrive at the focal point at the same time.

The number of elements driven is determined by element sensitivity off axis and depth of field considerations. The
waveform is selected to drive the transducer at a certain center frequency, bandwidth, and power and is optimized
for the given mode.
The receive section consists of a transmit/receive switch to protect the receiver from the transmit voltage, a vari-
able gain receiver to amplify and condition the return echoes, an A/D to digitize the data, a delay block to focus
the return signals and a weight block to scale the return echoes for each channel. All the signals are then summed
together to generate the beam-formed receive data. The analog gain varies with depth to compensate for signal
attenuation through the medium. The delays and weights are independent for each channel. The delay and
weight for the receive channel can typically be changed dynamically to keep the receive beam in continuous
focus. The delay is simply set by the time of flight in the medium from the point of interest to the element, which
starts at skin-line and proceeds to the deepest depth of interest.
The control section drives the data to the various data path elements on a line by line basis, controls the timing of
the transmit and receive sections and controls the tagged information and timing of the data to the rest of the
system.

PW Doppler Processing
Doppler processing includes both audio processing which presents Doppler signal in the form of stereo audio and
spectral processing which generates data for display of Doppler spectrum in the form of a scrolling spectrogram.
Doppler power spectrum is estimated performing Discrete Fourier Transforms on short, overlapped segments of
wall filtered Doppler signal. Doppler audio data is generated from wall filtered data by phase shifting the in-phase
component.PW Doppler Processing Function Block Diagram
Peak &
Mean
Back
End
Temporal Baseline Display
Compress
Averaging shift Interpolate
Wall Post
QBP Resample Window FFT |.|
Filter Gain
RF
Audio Output
indicates IQ pairs
I Hilbert + + Audio
Phase Shifter Gain
+
+ 2x16 bits @ PRF rate
Audio
Delay +
Q - Gain
Figure 4.3 PW Doppler Processing Function Block Diagram

CW Doppler Processing
CW Doppler data will be presented to the signal processor as complex (I/Q) data from the analog front end of the
external DSP. The 16-bit data will be presented as consecutive samples at a data rate varying from 1.5 kHz to 64
kHz for the complex pair. Most of CW processing is similar to that of PW except for the QBP function. In place of
QBP will be a low pass decimating filter that operates on incoming I/Q data.
The Doppler Processing block must allow storage of 128 undetected I/Q pairs in to allow the system to measure
and correct for phase mismatch. Measuring and correcting will need to be accomplished in system software.
MuxMux
CW Asic
CW Asic PCB PCB DSP DSP
Amplifier
Amplifier
Other Channel with
same Delay
Other Channel with
same Delay
Freq LO I
Q
Freq LO Gen LO I
Delay LO Q
LO Gen
Delay
Master Clk LO Q
I
Master Clk
Q
I Q Q Q Q Q Q Q Q
A/D A/D Complex
Complex
QSum QSum Wall Filter/ To To Doppler
Doppler
Wall Filter/ A/D Filter BP PRF
I-V I-V I I A/D Filter I I
I
BP PRF Processing
Processing
I
I Sum I Sum I FilterFilter I
A/D A/D
I Sample Clock
Sample Clock
Mux Q
I
Q
Mux Amplifier
Other Channel with
same Delay
Amplifier Freq LO I
Other Channel withLO Gen
Delay
same Delay LO Q
Master Clk
Freq LO I
LO Gen
Delay LO Q
Master Clk
Figure 4.4 CW Doppler Processing Function Block Diagram

Back End Overview
The Back End subsystem is responsible for the conversion of raw acquisition data into a raster image ready for
display. The Back End subsystem also contains the video data path that supports generation of video comprising
of the ultrasound image as well as graphics annotation. Video generation of both standard composite interlaced
video and progressive scan video is supported. Most functionality is within the ASIC but the memory resources for
acquisition memory, and display memory are found in external memory components. The conversion from PC
type video to TV type video is also performed externally.
Control is received initially from the CPU to setup each functional block and afterward the hardware is completely
data driven. This control takes the form of programming setup registers inside the blocks and setting up scan
conversion tables. Each block provides temporary storage as required to buffer data and keep their respective
processing pipeline full and operating. Also note that the block diagrams show only the data path, but each block
is responsible for generating any necessary memory addresses for their respective input data stream.
The Edge Back End subsystem is shown in the figure below.
Figure 4.5 Back End Subsystem Block Diagram
The Back End Subsystem performs processing encompassing three main data domains, acquisition data, raster
data, and video data. Support for acquisition data includes the input buffer, flash suppression, frame average, and
external ACQ memory. Cine buffer management is performed by the acquisition controller. Conversion from
acquisition data to raster data is performed by the graphics overlay, scan conversion engine, sweeping engine,
and 3D engine. Raster data is stored in an external DISPLAY memory. Also supporting raster operations is the
graphics support block that provides acceleration hardware for pixel operations from the CPU and graphics over-
lay engine. Video data is processed as progressive scan and supplied externally on a digital bus. In addition, inter-
laced video is supplied in both composite and S-video formats. The progressive video path includes buffers,
priority logic, and LUTs. External video in signals are input and multiplexed onto the external video out path to
allow for external sources to display information on connected displays, VCRs, or printers.

Control Subsystem
The Edge Control Subsystem is shown in the figure below.
SYSPWR,
INFRASTRUCTURE SYSCLKS, MASS
SYSRST EXPANSION STORAGE
ETHERNET FAST
ETHERNET
SYSTEM SYSTEM
FLASH RAM
PCI BUS
2 U/I, DEBUG
PCI BRIDGE DUAL UART,
USB
USB
DATA
SYSTEM BUS ADDRESS
CONTROL
SH MUX
SYSTEM IIC SH CONTROL
FLOATING
TIMERS DMA CONTROLLER
POINT CONTROL
cache
SH BUS
INTERRUPTS
PROCESSOR
8 GPIO ULTRASOUND VIDEO

JTAG SCANHEAD
DATA PATH AUDIO
ECG
IIC BUS DATA

CONTROL
Figure 4.6 Control Subsystem Block Diagram
The core control subsystem contains the processor, the system bus, the system memory resources of FLASH and
RAM, the interrupt logic, system timers, a DMA engine, and a floating point unit. Support for the ultrasound sub-
system consists of a scanhead interface, scanhead mux control.
Communication interfaces consists of an Ethernet interface, USB port, two general purpose serial bus interfaces,
and the IIC bus. The EDGE control architecture is an open architecture. It supports functionality extension through
the incorporation of the PCI bridge to the PCI bus. Functionality may be added by adding to the PCI Bus.

Power Supply and Control
The Edge Power Supply and Control System consists of an easily replaced rechargeable battery pack; an On/Off
Key; a standby power regulator; digital, analog, display and transducer power supplies; a power monitor and a
power control system. Operating current is drawn from the battery or an external AC/DC Adapter which also
contains circuitry for charging the battery. A fan and provision for a temperature sensor are also included.
Figure 4.7 Power Supply and Control Subsystem Block Diagram

Battery Pack (VBAT)
A rechargeable lithium-ion battery pack will be used to operate the unit in battery mode. The pack will include a
capacity monitoring circuit and any required pack protection circuitry. A one-wire, bidirectional, serial interface
(BDATA) will be used to read and write the pack data.
Battery Charger
The charge circuitry is in the external AC/DC Adapter as shown in the following block diagram.
POWER SUPPLY / BATTERY CHARGER Output Cable SYSTEM
Voltage +15VDC
5 5
Source
Universal Current Limited Current Ferrite / VCHG VBAT+

Common 2 2
AC Voltage Source Sense
Mode
Input
Choke
Line 3 turns on
Fair Rite
Neutral PN: Ferrite
263162510
Ground 2 RATE/SYNC
3 3
Charge System
Control 20K Power
Voltage 2K Supply
0.1 R2 VSENSE VBAT-
10 Sense 4 4
UF UF
.C57
.01uF PWR_RETURN
1 1
Cable Shield
Figure 4.8 Battery Charging Subsystem Block Diagram

ECG Module
The ECG module allows a representation of the heart electrical activity to be displayed in real time with ultrasound
images acquired and displayed on the system video display.
The ECG module interfaces to the patient through three (3) ECG leads: Right Arm ECG lead (RA), Left Arm ECG lead
(LA), and Left Leg ECG lead (LL). The ECG received signal from the ECG electrodes are isolated, amplified, and
filtered by the ECG module before it is sent to the system for further processing and display.
The ECG module and cable are an integrated assembly. The module receives power from the system. Patient
isolation is provided by the ECG module, allowing the connection and signals to the system to be system-ground
referenced. The isolation between the patient and the system meets the requirements of IEC 601-1 for Type CF
equipment.
The ECG function accepts input from an external serial A/D and performs gain, filter, DC Offset and trigger
functions. The resultant data is output at either the 200Hz sample rate or decimates the data by 2 or 4 and outputs
the data into acquisition memory. The data is assumed to be signed. The ECG trigger function is implemented by
a simple edge sensitive trigger along with SW monitoring the ECG data and triggering the FE after a user defined
delay from the detected R wave. An interrupt is provided that will interrupt the processor after a set delay from the
detected level and slope. A simple block diagram of the HW is shown below.
Figure 4.9 ECG Block Diagram
DICOM
The system features Digital Imaging and Communications (DICOM) capability to provide the acceptance, transfer,
display, storage, and digital processing of single ultrasound images as well as loops of ultrasound images.
IMT
The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital
ultrasound images. The intima is that region of the arterial wall from and including the endothelial surface at the
lumen to the luminal margin of the media. The media layer extends from the intima to the adventitia of the vessel
wall. The adventitia is normally quite echogenic on ultrasound images when compared to the media. The IMT
measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to
help assess the cardiovascular health of a patient.

Chapter 5: Troubleshooting
This chapter contains information to help you correct problems with system operation.
System and Subsystem Diagnosis

This section covers basic diagnostic and troubleshooting procedures you may follow if the system does not
operate properly. To diagnose system failures, consult the referenced diagnostic figures that follow or SonoSite
Technical Support.
Table 5.1: Troubleshooting Subassemblies and Diagnostic Figures
Subassemblies Diagnostic Figures or Table
DICOM Table 5.2
Display TBA
Battery TBA
Control Panel TBA
System Repair
The system is repairable through subassembly replacement or through replacement of parts as recommended by
SonoSite. Component level repair of Printed Circuit Board Assemblies is performed only at the SonoSite repair
facility. Replacement of board level components by unauthorized service facilities voids the SonoSite warranty.
Test Equipment
Test equipment is not required for this troubleshooting section. Troubleshooting test aids include an external
monitor and a spare battery.
Chapter 5: Troubleshooting 35
Failure (Assert) Codes
The system displays an “assert screen” for hardware and software issues related to Main PCBA failures. Main PCBA
failures typically result in “assert codes” that are output to the display. If an assert screen appears, note the assert
information and contact SonoSite Technical Support to clarify the failure. Figure 5.1 shows an assert screen. The
assert information required is the information listed on the “C:” line and the “D:” line.
Record all information on the “C:” line and

“D:” line and contact Technical Support
Figure 5.1 Assert Screen
Verifying a System Assert Code

System asserts are caused by hardware and/or software faults. Hardware asserts typically require main PCBA
replacement. Software asserts can be reset and the system may recover. A simple method to identify the cause of
the assert is identified here:
Assert Cause 1 Record the assert code.

2 Press and release the Power button to power the system down.
3 Press the Power button again to power on the system.
• If the system powers on normally, it has recovered from the fault (software assert) and
you may use the system.
• If the assert condition remains, corrective action must be taken; usually replacement of
the main PCBA is required. Contact SonoSite Technical Support for assistance and to
obtain repair parts.
If the Power button is not functional, all sources of power must be removed to allow the
system to power down. I.e., disconnect AC power and remove the battery.
36 Chapter 5: Troubleshooting
DICOM
Table 5.2: DICOM Troubleshooting
Error Message Tiller Error Code Cause Troubleshooting
Socket TSOCKET_CONNECT_FAILURE Invalid network Using Ping, verify that the

communication configuration. Printer/Archiver is connected.
failed Wrong port • If Ping fails, check the devices IP
number. address, Edge IP address,
Application is not Subnet mask, and Gateway IP
running. address.
Printer is offline. • If Ping is OK, use Verify to check
if device is available.
If Verify fails:
a) Check the Printer/Archiver’s
Port configuration on the Edge.
b) Ensure that the Printer is
online and the Archiver’s
application is running.
Archiver TDICARCH_OPEN_FAILURE Wrong Capture Verify that the Archiver supports

transaction Type selected the selected Capture Type setting,
failed e.g., US Image, SC Image or
US-Ret Image.
Printer TDICPRNT_OPEN_FAILURE Wrong Image Verify that the printer supports

transaction settings the selected Image settings. E.g,.
failed Color (RGB) or Grayscale
(Monochrome)
DICOM network TDNETWORK_OPEN_FAILURE Device does not Verify that Edge AE Title or IP
communication recognize Edge, address is correctly configured on
failed rejects association the Printer/Archiver.
Note: Some devices require that the
Imaging modality (Edge) be
recognized in order to accept
images. This requires configuration
on the device.
Internal failure TDNETWORK_READ_FAILURE Invalid DICOM Check Edge Printer DICOM

detected Attribute settings for correctness (e.g., film
size, format)
Chapter 5: Troubleshooting 37
38 Chapter 5: Troubleshooting
Chapter 6: Replacement Procedures
Caution:
Always use correct ESD procedures. ESD damage is cumulative and may not be noticeable at first. Initial ESD
symptoms may be slightly degraded performance or image quality.
Caution:
All fasteners should be torque to 5.5-inch pounds except where noted such as the Control Panel Subassembly
which is should be torque to 3.0-inch pounds.
Display Replacement
Required Parts
One of the following:
• P15637 Service Assembly, Display, EDGE
• P15638 Warranty Service Assembly, Display, EDGE
• V15637 Vet Service Assembly, Display, EDGE
• V15638 Vet Warranty Service Assembly, Display, EDGE
Required Tools
• #1Phillips screwdriver
• #2 Phillips screwdriver
• Torque screwdriver, 2.0-10.0 inch pounds (0.23-1.1 Newton meter)
• An anti-static mat
• A wrist grounding strap
Display Removal
(Please be advised that the EDGE Display is now a complete assembly comprised of the top cover, display frame,
wiring harnesses, hinges, and bezel. Do not attempt to replace the LCD as this is not possible as a field
replacement.)
Display Removal
1 Lay the EDGE System on its top exposing the bottom section and remove the system battery.
2 Remove the eight screws from the Bottom Enclosure of the system with a #2 Phillips screw driver per
Figure 6.1.
Chapter 6: Replacement Procedures 39

Screws (8x)
Figure 6.1 System Bottom
3 After removing the EDGE Bottom Enclosure, remove the two screws located in Figure 6.2.
Don’t forget these two

screws to release the top
enclosure. (Refer to both
arrow lines in the figure
to the left).
Figure 6.2 Main Frame Bottom
Caution:
Use caution when removing the Top Enclosure area under the Display. This area is retained with an adhesive strip
and using too much force will break the Top Enclosure requiring replacement.
Carefully slide a small flat bladed screwdriver from one side to the other to release the tape.
4 Turn the system over, fully open the display, and remove the EDGE Top Enclosure per Figure 6.3.
40 Chapter 6: Replacement Procedures

Caution:
Adhesive backing under
this area.
Lift front area first.
Figure 6.3 System Control Panel View
5 Remove the 10 perimeter screws holding the Control Panel, carefully lift from under the Control Panel and
slide forward. Refer to Figure 6.4.
Screws
(10x)
Front Edge
Figure 6.4 Control Panel Removal
6 Remove the 2 screws holding the Hinge Cover and remove per Figure 6.5.

Hinge Cover
screws (2x)
Figure 6.5 Hinge Cover
Caution:
When lifting the front edge of the Control Panel away from the Main Frame, lift under the Control Panel board. Do
not lift by the rubber membrane. This can easily become detached from the Control Panel board and cannot be
refastened!
7 Expose the underside of the Control Panel by lifting from under the front edge and hinge via the top edge
toward the LCD display.
8 Remove the J6 “LCD OUT”, J8 “BL OUT”, J5 “LCD IN” and J7 “BL IN” cables by gently pulling away from their
sockets.
9 Remove the J4 “SPI” and J9 “GAIN” ribbon cables after unlocking the dark gray retainer on both sockets as
shown in Figure 6.6.
Caution:
J4 & J9 require the gray lock
J9
tab to be lifted at the end
closest to the ribbon cable...
Use care as the lock tab
hinge points are fragile.
J5
J4
J6 J7 J8
Figure 6.6 Control Panel Bottom
10 Tilt the system back onto the top cover allowing the LCD to lie on its back.
11 Remove the 4 screws from the LCD display hinges as shown in Figure 6.7.

Screws (4x)
Figure 6.7 Display Screws
Display Replacement
Display Replacement
1 Set the new Display Assembly in place.
2 Install the four hinge screws that hold the Display Assembly in place. Torque the screws to 5.5-inch pounds.
3 Place the Control Panel onto the EDGE frame.
4 Connect both Display Assembly cables (J6 “LCD OUT” & J8 “BL OUT”) to the Control Panel and (J5 “LCD IN” &
J7 “BL IN”) from the Main PCBA to the Control Panel.
5 Connect both ribbon cables (J4 “SPI” & J9 “GAIN”). Lock the J4 and J9 cable retainer in the closed position.
6 Reinstall the ten screws that hold the Control Panel in place. Torque the screws to 3.0-inch pounds.
7 Install the Hinge Cover and two screws removed per Figure 6.5. Torque the screws to 3.0-inch pounds.
8 Install the EDGE Top Enclosure by sliding and snap down into place.
9 Close the Display Assembly and turn the system over.
10 Install the two screws removed from Figure 6.2. Torque the screws to 5.5-inch pounds.
11 Install the eight screws on the bottom of the system per Figure 6.1. Torque the screws to 5.5-inch pounds.
Test the Display

Test Display
1 Replace the battery or attach an external power supply.
2 Press the Power key to apply power to the system.
3 Verify the display operates correctly.

Control Panel Subassembly Replacement
Required Parts
One of the following:
Service Assembly Control Panel Warranty Service Assembly Control Panel
P15618-01 Control Panel, EDGE, English P15630-01 Control Panel, EDGE, English
P15621-01 Control Panel, EDGE, French P15631-01 Control Panel, EDGE, French
P15622-01 Control Panel, EDGE, German P15632-01 Control Panel, EDGE, German
P15623-01 Control Panel, EDGE, Italian P15633-01 Control Panel, EDGE, Italian
P15624-01 Control Panel, EDGE, Spanish P15634-01 Control Panel, EDGE, Spanish
P15625-01 Control Panel, EDGE, Russian P15635-01 Control Panel, EDGE, Russian
P15626-01 Control Panel, EDGE, Portuguese P15636-01 Control Panel, EDGE, Portuguese
Required Tools
Caution:
Control Panel Removal

Control Panel Removal
1 Lay the EDGE System on its top exposing the bottom section and remove the system battery.
2 Remove the 8 screws from the Bottom Enclosure of the system using a #2 Phillips screwdriver per Figure 6.1.
3 Remove the 2 screws in the EDGE Main Frame securing the Top Enclosure per Figure 6.2.
Use caution when removing the Top Enclosure area under the Display. This area is retained with an adhesive strip
and using too much force will break the Top Enclosure requiring replacement. Carefully slide a small flat bladed
screwdriver from one side to the other to release the tape.
Caution:
When lifting the front edge of the Control Panel away from the Main Frame, lift under the Control Panel board. Do
not lift by the rubber membrane. This can easily become detached from the Control Panel board and cannot be
refastened!
4 Turn the system over, fully open the Display Assembly, and remove the EDGE Top Enclosure per Figure 6.3.
5 Remove the ten perimeter screws holding the Control Panel, carefully lift, and slide forward. Refer to Figure 6.4.
6 Expose the underside of the Control Panel by lifting from the front EDGE and hinge via the top EDGE toward
the LCD display.
7 Remove J6 “LCD OUT”, J8 “BL OUT”, J5 “LCD IN”, and J7 “BL IN” cables by gently pulling away from their sockets.
8 Remove the J4 “SPI” and J9 “GAIN” ribbon cables after unlocking the dark gray retainer on both sockets as per
Figure 6.6.
9 Lift off the loose and un-tethered Control Panel assembly from the EDGE frame.

Control Panel Replacement
Control Panel Replacement
1 Place the new Control Panel onto the EDGE frame and line-up the holes as per Figure 6.8.
Line up these holes with the

holes in the core before
tightening the screws
otherwise top enclosure is
difficult to fit.
Figure 6.8 Control Panel Alignment
2 Expose the underside of the Control Panel by lifting from the front edge and hinge via the top edge toward
the LCD display.
3 Connect the J4 “SPI” and J9 “GAIN” ribbon cables and lock the dark gray retainer on both sockets as shown in
Figure 6.6.
4 Connect the J6 “LCD OUT”, J8 “BL OUT”, J5 “LCD IN”, and J7 “BL IN” cables.
5 Install the ten screws removed per Figure 6.4. Torque the screws to 3.0-inch pounds.
6 Install the EDGE Top Enclosure and push into place.
7 Close the display and turn the system over.
8 Install the 2 screws in the EDGE Main Frame securing the Top Enclosure per Figure 6.2. Torque the screws to
5.5-inch pounds.
9 Install the eight screws on the Bottom Enclosure of the system per Figure 6.1. Torque the screws to 5.5-inch
pounds.
Main System Disassembly for Repair and/or Replacement
Required Parts
• Main PCBA
• P15615 Service Assembly Main PCBA, EDGE
• P15617 Warranty Service Assembly Main PCBA, EDGE
• V15615 Vet Service Assembly Main PCBA, EDGE
• V15617 Vet Warranty Service Assembly Main PCBA, EDGE
Note: The replacement Main PCBA does not include the Transducer Nest Frame Assembly. These parts must be
transferred from the original Main PCBA. If new parts are required, please order the following components to complete
the Transducer Nest Frame Assembly.

• Nest Frame Assembly, M-Turbo (Compatible with EDGE system):
• P07750 Nest Frame Assembly
• P00364 Connector, Interposer (8x)
• P03833 Shield, Perimeter, Short (2x)
• P03834 Shield, Perimeter, Long (2x)
• P00924 Screw, Shoulder, Thrust Plate (4x)
• P00353 Wear Plate
• P00646 Spring, Thrust Plate, .047 wire (4x)
• P08200 Socket Head Cap Screw, M2.5-.45x10mm (4x)
Required Tools
• 2 mm allen key
Caution:
System Disassembly
System Disassembly
1 Remove the battery.
2 Remove the Bottom Enclosure from the system following the removal procedures in “Display Removal” on
page 39.
3 Remove the Top Enclosure and Control Panel from the system following the removal procedures in “Display
Removal” on page 40.
4 Follow the cable removal from the procedure in “Display Removal” on page 42. This exposes all of the
replacement parts for the main system per Figure 6.9.
Major System Components
Main PCBA
USB Extension Fan
CB Assembly
Nest Frame Assembly
SD Card
Daughter-card Power Supply
under shield) (under shield)
Speaker Speaker
Figure 6.9 System Components

Speaker Replacement
Required Part
• P03872 Speaker Assembly
Caution:
Use caution when removing the left speaker connector to prevent damage to the Main PCB A components
around the connector.
Speaker Replacement
1 Press on the connector release and pull the connector out of the receptacle.
2 Gently pry off the retaining clip with a flat bladed pry tool. See Figure 6.10.
3 Replace the speakers by reversing steps 1-2.
Connector
Speaker
Retaining Clip
Figure 6.10 Speaker Replacement

Power Supply PCBA Replacement
Required Part
• P08850 Service Assembly, Power Supply, M-Turbo (Compatible with the EDGE system)
Power Supply Removal
1 Remove the 7 long screws and 2 short screws holding the Power Supply Shield. Please note the location of
the 2 short screws. See Figure 6.11.
Power Supply
shield
Long Screws (7x)
Short Screws (2x)
Figure 6.11 Power Supply Shield
2 Gently lift the Power Supply PCBA away from the Main PCBA as shown in Figure 6.12. (Connector in upper left
corner/removing the Power Supply PCB without the shield is difficult)
3 Install the new Power Supply PCBA by reversing steps 1-2.
Power Supply connector

underneath mates Power
Supply PCB to the Main
PCBA.
Power Supply PCBA
Figure 6.12 Power Supply PCBA

SD Card Daughter-card
Required Parts
• P10168 SD Card, 2GB (4 required)
• P07442 SD Card Daughter-card
SD Card Daughter-card Removal
1 Remove the 1 long screw holding from the SD Card Daughter-card. See Figure 6.13.
USB Extension PCB
SD Card
Daughter-card
alignment pins
Long Screw (1x)
Note: Kapton tape

is used to retain SD
Card in place.
Figure 6.13 SD Card Daughter-card
2 Gently lift the SD Card Daughter-card straight up away from the Main PCBA.
SD Card Daughter-card Replacement
1 Install the SD Card Daughter-Card onto the Main PCBA frame using the alignment holes/pins on the card and
frame. See Figure 6.13.
Caution:
Improper installation of the SD Card Daughter-card will cause all or part of the internal image storage memory to
not be recognized by the system.
2 Install the 1 long screw ensuring the proper location. See Figure 6.13.
3 Install the 7 long screws and 2 short screws holding the Power Supply Shield. Please note the location of the
2 short screws. See Figure 6.11.

USB Extension PCB Assembly Replacement
Required Part
• P14727 USB Extension PCB Assembly
USB Extension PCB Assembly Removal
Note: Please proceed to the Main PCBA Replacement section as all the steps detailed to replace the Main PCBA will
require the removal of the USB Extension PCB Assembly.
Main PCBA Replacement

Main PCBA Removal
1 Remove the Power Supply PCBA and SD Card Daughter-card as described in the previous steps.
2 Disconnect the power cable to the Fan Assembly and remove the 2 screws mounting the Fan Assembly. Refer
to Figure 6.14.
Screws (2x)
Small Hole Large Hole (key)
Figure 6.14 Fan Assembly Screws
3 Remove the 5 screws holding the Main PCBA and the 2 screws holding the USB Extension PCB onto the EDGE
Base. Refer to Figure 6.15.
4 Disconnect the speaker wires from the Main PCBA.
Caution:
Use caution when removing the left speaker connector to prevent damage to the Main PCBA components around
the connector.

Screws (5x)
Screws (2x)
Figure 6.15 Main PCBA Screws
5 Turn the system over.

6 Remove the 4 Socket Head Cap Screws as shown in Figure 6.16. This releases the Nest Frame and will allow the
Main PCBA to be removed.
7 As you remove the nest frame assembly from the PCBA, tilt the PCBA and enclosure to almost vertical to avoid
spilling the Interposer Connectors from the assembly.
Note: The Nest Frame is keyed onto the Main PCBA via two smaller and two larger hole sizes. Installing incorrectly (180
degrees out) will result with the EDGE system unable to recognize any connected transducers.
8 Lift on the edge of the Main PCBA closest to the system handle at the front right edge. Pull up from the side
where the Fan Assembly mounts.
9 Disconnect the USB Extension PCB Assembly from the Main PCBA.
Screws (4x)
2.5mm Socket Head Cap Screw
Figure 6.16 Nest Frame Top Screws

Main PCBA Replacement
Replace the Main PCBA by following the reverse of the removal procedure. Do not tighten all the screws until
everything is in place.
1 Connect the USB Extension PCB Assembly to the Main PCBA.
2 Replace the Main PCBA.
3 Reinstall the Fan Assembly.
4 Reinstall the Nest Frame Assembly. The Nest Frame Socket Head Cap Screws should be torque to 4.5-inch
pounds.
Caution:
The Nest Frame is keyed onto the Main PCBA via two smaller and two larger hole sizes. Installing incorrectly (180
degrees out) will result with the EDGE system unable to recognize any connected transducers. Refer to
Figure 6.14.
5 Reconnect the speaker wires.
6 Reinstall the Power Supply PCBA.
7 Reinstall the SD Card Daughter-card.
8 Reinstall the Power Supply Shield.
9 Tighten all screws to their specified torque of 5.5-inch pounds.
10 Reinstall the Control Panel.
11 Reinstall the Top Enclosure Assembly.
12 Reinstall the Bottom Enclosure.
Middle Machined Enclosure Replacement
Required Parts
• P15304-04 Enclosure, Middle, Machined
• P15984-01 Gasket, EMI/ESD (2 Required)
• P07885-01 Thermal Pad, 1.00 x 1.00 x 0.100” (4 Required)
• P07886-01 Thermal Pad, 0.35 x 0.35 x 0.100” (4 Required)
Middle Machined Enclosure Replacement
Note: The EMI/ESD Gaskets and the Thermal Pads may be reused from the old assembly but advise having new items
to ensure that these will contact the necessary areas properly.
1 Refer to P15304 for a view of the Middle Machined Enclosure on page 73.
2 Follow all the above procedures to remove all PCB and PCBA assemblies as well as all the hardware fastened
from the original Middle Machined Enclosure.
3 Transfer all the components to the new Middle Machined Enclosure.
4 Finish assembly by reversing step 2.
Bottom Enclosure Replacement
Required Parts
Note: Contact SonoSite Technical Support if it is necessary to replace the bottom enclosure. Ordering the bottom
enclosure requires special handling due to the serial number label

Chapter 7: Maintenance
This chapter contains information to help you properly care for the system, transducers, and accessories.
Periodic Maintenance
No periodic or preventive maintenance is required for the system, transducers, or accessories other than cleaning and
disinfecting the transducer after every use. (See “Cleaning and disinfecting transducers” on page 55.) There are no
internal adjustments or alignments required and there are no internal components that require periodic testing,
calibration, adjustment, or alignment. Performance tests are described in Chapter 8, “Performance Testing” of this
manual. Performing maintenance procedures not described in this manual may void the product warranty.
Local regulations may require electrical safety testing.
Contact SonoSite Technical Support for any maintenance questions. (See “Technical Support (USA, Canada)” on
page 1.)
Cleaning and disinfecting

Use the recommendations in this section when cleaning or disinfecting the ultrasound system, transducer, and
accessories. Use the cleaning recommendations in the peripheral manufacturer’s instructions when cleaning or
disinfecting peripherals.
For recommended cleaners and disinfectants, see the disinfectant list available on the CD included with the ultrasound
system and on www.sonosite.com.
WARNING: Disinfectants and cleaning methods listed are recommended by SonoSite for
compatibility with product materials, not for biological effectiveness. Refer to the
disinfectant label instructions for guidance on disinfection efficacy and
appropriate clinical uses.
WARNING: The level of disinfection required for a device is dictated by the type of tissue it
contacts during use. To avoid infection, ensure that the disinfectant type and the
solution strength and duration are appropriate for the equipment. For information,
see the disinfectant label instructions and the recommendations of the
Association for Professionals in Infection Control and Epidemiology (APIC) and
the FDA.
WARNING: To prevent contamination, the use of sterile transducer sheaths and sterile
coupling gel is recommended for clinical applications of an invasive or surgical
nature. Do not apply the transducer sheath and gel until you are ready to perform
the procedure.
Caution: Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling
for devices that contain natural rubber.
Chapter 7: Maintenance 53
Cleaning and disinfecting the ultrasound system
The exterior surface of the ultrasound system and the accessories can be cleaned and disinfected using a recommended
cleaner or disinfectant.
WARNING: To avoid electrical shock, before cleaning, disconnect the system from the power supply or
remove from the mini-dock or docking system.
WARNING: To avoid infection always use protective eyewear and gloves when performing cleaning and
disinfecting procedures.
WARNING: To avoid infection, ensure that the solution expiration date has not passed.
Caution: Do not spray cleaners or disinfectant directly on the system surfaces. Doing so may cause
solution to leak into the system, damaging the system and voiding the warranty.
Caution: Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since these will
damage the exterior surfaces.
Caution: Use only recommended cleaners or disinfectants on system surfaces. Immersion-type
disinfectants are not approved for use on system surfaces.
Caution: When you clean the system, ensure that the solution does not get inside the system controls or
the battery compartment.
Caution: Do not scratch the LCD screen.
To clean the LCD screen

Dampen a clean, non-abrasive, cotton cloth with an ethanolic-based cleaner, and wipe the screen clean. Apply the
cleaner to the cloth rather than the surface of the screen.
To clean and disinfect system surfaces

1 Turn off the system.
2 Disconnect the system from the power supply, or remove it from the mini-dock or docking system.
3 Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to
remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Mix the disinfectant solution compatible with the system, following disinfectant label instructions for solution
strengths and disinfectant contact duration.
5 Wipe surfaces with the disinfectant solution.
6 Air dry or towel dry with a clean cloth.
54 Chapter 7: Maintenance
Cleaning and disinfecting transducers
To disinfect the transducer and its cable, use the immersion method or the wipe method.
WARNING: To avoid electrical shock, before cleaning, disconnect the transducer from the system.
WARNING: To avoid injury, always use protective eyewear and gloves when performing cleaning and
disinfecting procedures.
WARNING: To avoid infection, ensure that the solution expiration date has not passed.
Caution: Transducers must be cleaned after every use. Cleaning transducers is necessary prior to effective
disinfection. Ensure that you follow the manufacturer's instructions when using disinfectants.
Caution: Do not use a surgeon's brush when cleaning transducers. Even the use of soft brushes can
damage a transducer. Use a soft cloth.
Caution: Using a non-recommended cleaning or disinfection solution, incorrect solution strength, or
immersing a transducer deeper or for a longer period of time than recommended can damage or
discolor the transducer and void the transducer warranty.
Caution: Do not allow cleaning solution or disinfectant into the transducer connector.
Caution: Do not allow disinfectant to contact metal surfaces. Use a soft cloth lightly dampened in a mild
soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces.
Caution: Attempting to disinfect a transducer or transducer cable using a method other than the one
included here can damage the transducer and void the warranty.
To clean and disinfect a transducer (wipe method)

1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any
particulate matter or body fluids.
4 Rinse with water or wipe with water-dampened cloth; then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer, following disinfectant label instructions for solution
6 Wipe surfaces with the disinfectant solution.
7 Air dry.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local representative.
To clean and disinfect a transducer (immersion method)
1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the surface using a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any
particulate matter or body fluids.
4 Rinse with water or wipe with water-dampened cloth, and then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer, following disinfectant label instructions for solution
6 Immerse the transducer into the disinfection solution not more than 12-18 inches (31-46 cm) from the point where
the cable enters the connector.
Follow the instructions on the disinfectant label for the duration of the transducer immersion.
7 Using the instructions on the disinfectant label, rinse to the point of the previous immersion, and then air dry or
towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local representative.
Cleaning and disinfecting the battery

Caution: To avoid damaging the battery, do not allow cleaning solution or disinfectant to
come in contact with the battery terminals.
To clean and disinfect a battery (wipe method)

1 Remove the battery from the system.
2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution.
3 Wipe the surfaces with the disinfection solution. Sani-Cloth HB, Sani-Cloth Wipes, or 70% isopropyl alcohol is
recommended.
4 Air dry.
Cleaning the footswitch

Caution: To avoid damaging the footswitch, do not sterilize. It is not intended for use in a
sterile environment.
To clean the footswitch

1 Dampen a non-abrasive cloth with one of the following products:
• Isopropyl alcohol
• Soap and water
• Cidex
• Sodium Hypochlorite 5.25% (Bleach) diluted 10:1
2 Wring out cloth until slightly wet and then gently rub soiled area until clean.
Cleaning and disinfecting ECG cables
Caution: To avoid damaging the ECG cable, do not sterilize.
To clean and disinfect the ECG cable (wipe method)

1 Remove the cable from the system.
2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution.
3 Wipe the surfaces with any of the following products:
• Bleach (sodium hypochlorite)
• Cidex disinfectants
• Green soap
4 Air dry or towel dry with a clean cloth.
Chapter 8: Performance Testing
Overview
WARNING: Critical Test Function — A failure of the system functions tested in this section could affect
safety or effectiveness of the system adversely. While performing the steps in this section, verify
that the images on the system display and on the external monitor are acceptable.
To obtain 2D images, SonoSite recommends using the Gammex 403GS Soft Tissue Phantom or the Gammex 413A
Multipurpose Phantom. A .7db/cm phantom is recommend but not required.
Some features and capabilities are optional and therefore may be unavailable to test.
Recommend Test Equipment

• SonoSite ultrasound system under test
• C60x/5-2 MHz transducer
• P21x/5-1 MHz transducer
• Gammex 403 GS Multipurpose Phantom, 413A Soft Tissue Phantom, or equivalent.
• Acoustic gel
Setting Up Performance Tests
Set up 1 Attach the C60x/5-2 MHz transducer to the system.

Performance 2 Select Gen for optimization and OB for exam type.
Tests 3 Couple the transducer to the phantom, adjusting gain settings and transducer for a proper
phantom image (e.g., pins are high-level echoes positioned in straight lines; cysts are
sonolucent, edges are sharp, and graphite particles of the phantom are mid-grays).
Chapter 8: Performance Testing 59

Basic Operational Tests
Basic System 1 Verify that the correct transducer name appears in the upper right corner of the system
Operation display.
Tests 2 Verify proper date and time.
3 Verify that the scan plane orientation mark in the image located near the skinline
corresponds to element #1 on the transducer. To test, put your finger on the probe and run
it across the transducer face. Your finger touching the transducer face should appear at the
orientation mark on the display image format.
4 Verify that all of the keyboard keys are functional. Verify that all controls operate smoothly
over their full range and that the system responds properly.
5 Verify that as the Gain controls are increased and decreased, there is a corresponding
increase and decrease in echo intensity.
6 Capture a Cineloop buffer. Exercise the Cineloop controls and verify proper operation.
7 Close the lid and verify the unit goes into sleep mode. Open the lid and verify the unit
returns to normal operation.
8 Verify the airflow from the vent on the left side of the system is blowing out.
2D Performance Tests
2D Performance / Image Quality
Test 2D 1 Use a C60x/5-2 MHz transducer in 2D mode.

Performance 2 Adjust the position of the C60x/5-2 MHz transducer on the phantom.
and Image 3 With the array pointing down and the orientation mark to the operator’s left, element #1
Quality corresponds with the left side of the array.
4 Use the 2D system controls to obtain a clear image that shows both the horizontal and
vertical rows of pins.
5 Verify that the ultrasound image appears uniform in both the axial and lateral direction,
with no dropouts or intensity variations.
6 Verify that the cystic structure at the focal zone is clearly differentiated from the
surrounding tissue and is echo-free, while solid tissue with numerous echo sources, appears
solid.
7 Press the Freeze key and then save the image. Press the Freeze key again to return to live
imaging.
60 Chapter 8: Performance Testing

Axial Measurement Accuracy
Note: Measurements must be performed while the image is frozen.
Set Up Axial 1 Acquire the image.

Measurement 2 Press the Freeze key.
Accuracy 3 Press the Caliper key. The caliper appears on the image display. (See the Edge Ultrasound
System User Guide, if necessary, for caliper operation.)
4 Use the touchpad to position one of the calipers.
5 Press the Select key to fix the caliper and enable the other caliper.
6 Use the touchpad to move the other caliper. The results update as you move the caliper, and
the measurement is complete when you finish moving the calipers. (Press the Select key to
alternate the active caliper, and adjust the measurement with the touchpad.)
Test Axial 1 Measure the distance, center to center, of any two pins that are 5-12 cm apart vertically.
Measurement 2 Verify that the distance measured is within the tolerance listed in Table 8.1.
Accuracy
Lateral Measurement Accuracy
Set Up Lateral Perform “Set Up Axial Measurement Accuracy” on page 61.

Measurement
Accuracy
Test Lateral 1 Measure the distance, center to center, of any two pins that are 4-10 cm apart horizontally.
Measurement 2 Verify that the distance measured is within the tolerance listed in Table 8.1.
Accuracy 3 Press the Freeze key to return the system to live 2D mode.
Table 8.1: System Measurement Accuracy
Measurements Tolerance
Axial Distance +/- 2%
Lateral Distance +/- 2%

Penetration
The penetration measurement is an integral part of the quality assurance program. Penetration is defined as the
deepest depth at which an ultrasound system can provide adequate image quality of small anatomical structures.
Penetration measurements should be performed and the results retained for comparison to future measurements.
Penetration measurements should remain fairly consistent over time assuming use of the same system settings
and scanhead. Degradation of the penetration measurement in excess of 1cm may indicate a transducer or system
electronics issue.
Loss of measured penetration may also be caused by degradation (dessication) of the ultrasound phantom.
Ultrasound phantoms used for penetration measurements must also be part of a quality assurance program to
maintain their integrity. Follow all of the phantom manufacturer recommendations for use, storage, and
maintenance of the phantom.
Test 1 Use the same scanhead and system settings as previous measurements if possible.
Penetration 2 Adjust the system controls to obtain a clear image that shows the limits of echo penetration.
3 Press the Freeze key and then save the image.
4 Measure from the center of the skinline to the deepest vertical position—where the scatter
echoes start to break up and tissue definition is lost.
5 Record and retain the results for future reference. Scanhead type and system settings (exam
type, depth, resolution mode, etc.) should also be recorded to ensure proper comparison
with future tests.
6 Press the Freeze key again to return to live imaging.
Additional Performance Tests
Color Doppler (Color)
Test Color 1 Connect any transducer.

2 Press the Color key. “Color” should be annotated in the top left corner of the display.
3 A Region of Interest (ROI) box is displayed on top of the grayscale image. Use the touchpad
to move the Color ROI. Verify that the ROI moves to the new position on the display.
4 Adjust the Depth control for minimum depth in the image.
5 Adjust the Gain control so that color speckles just appear inside the ROI box.
6 Gently tap the face of the transducer and observe that the ROI box fills with color
information.
imaging.

Color Power Doppler (CPD)
Test CPD 1 Connect any transducer.

2 Press the Color key. A Region of Interest (ROI) box is displayed on top of the grayscale image.
3 Press the Color softkey to switch to CPD. “CPD” should be annotated in the top left corner
of the display.
4 Adjust the Depth control for minimum depth in the image.
5 Adjust the Gain control so that color speckles just appear inside the ROI box.
6 Gently tap the face of the transducer and observe that the ROI box fills with color
information.
M Mode Imaging
Test M Mode 1 Attach a C60x transducer and acquire an image.

Imaging 2 Press the M Mode key for the M Mode sample line.
3 Position the M Mode sample line over the image using the touchpad.
4 Press the M Mode key again to turn on M Mode.
5 Select the desired sweep speed from the on-screen menu (slow, med, or fast). The on-screen
menu will show the selected sweep speed.
6 Press the Freeze key to freeze the image. Save the image. Press the Freeze key again to
return to live imaging.
7 Press the 2D key to return to 2D imaging.
Tissue Harmonic Imaging
Test THI 1 Attach the C60x transducer and acquire an image.

Imaging 2 Set the depth to maximum and note the depth at which echo information is lost.
3 Press the THI key on the control panel so it displays THI on the display. Tissue Harmonic
Imaging in now active.
4 Observe a decrease in dot size and a significant loss in penetration due to the higher
frequency. Image resolution increases.
imaging.
6 Press the THI key again to turn off Tissue Harmonic Imaging.

Pulsed Wave (PW) Doppler Imaging
Test PW 1 Attach the P21x transducer.

Doppler 2 Press the Doppler key for the Doppler sample gate.
Imaging 3 Press the Doppler key again for the Doppler spectral trace.
4 Place a large drop of ultrasound gel on the transducer lens.
5 Adjust the Gain control as necessary and then gently tap the top of the gel and observe a
reflection on the spectral trace and the sound from the speakers.
imaging.
Continuous Wave (CW) Doppler Imaging
Test CW 1 Attach the P21x transducer.

Doppler 2 Press the Patient key.
Imaging 3 Select the Cardiac exam type.
4 Press the Done softkey.
5 Press the Doppler key for the Doppler sample gate.
6 Press the PW softkey to switch to CW Mode.
7 Press the Doppler key again for the Doppler spectral trace.
8 Place a large drop of ultrasound gel on the transducer lens.
9 Adjust the Gain control as necessary and then gently tap the top of the gel and observe a
reflection on the spectral trace and the sound from the speakers.
imaging.
Image Quality Verification Test/Livescan

• Products with replaced subassemblies, or products that have been otherwise disassembled, must undergo an
Image Quality Verification Test/Livescan.
• The Image Quality Verification Test/Livescan should be performed after successfully completing all applicable
performance tests listed prior in this chapter.
• The test is completed before returning the system to service.
• A certified sonographer must perform the test.
• The Livescan test performed is at the discretion of the Sonographer and will represent their acceptance of a
successful service event.
• Review all saved images and verify that the images are displayed properly.

Printer
The printer test is an optional test that requires a video printer and minidock to be connected to the system under
test. Skip this test if a printer and minidock are not available.
Test Printer 1 Connect the minidock to the system under test.

Operation 2 Connect the video output of the minidock to the printer.
3 Verify proper printer type is configured in the system Setups page.
4 Press the print button and verify that the printer begins to print an image. After the image
begins to emerge from the printer, press the print button again. The printer should ignore
the second print command.
5 Verify the proper content of the printed image.
Battery Charging
Test Battery 1 Remove the system from the docking system and insert a battery into the system.
Charging 2 Press the Power key to turn the system on. Allow the battery to discharge. The battery
Operation indicator icon on the display, below the Transducer Type indicator, will extinguish from left
to right as the battery discharges.
Note: The Power and Sleep delays in the Setup page should be selected to “Off” to properly
perform this test. The battery may take 1–2 hours to discharge.
3 Reattach the system to the Docking System and attach the AC power cord to the power
connector.
4 Note that the battery indicator indicates that the battery is charging. The sections of the
battery indicator will light sequentially from left to right as the battery charges.
Video Output
The video output test is an optional test that requires a minidock and external video monitor to be connected to
the system under test. Skip this test if a minidock and external monitor are not available.
Test Video 1 Connect the minidock to the system under test.

Output 2 Connect the video output of the minidock to an external video monitor.
3 Turn on the system power and verify that the video on the external monitor matches the
video on the system display.
If the video does not appear similar, or there is no display on the external monitor, see
Chapter 5, “Troubleshooting” for troubleshooting procedures.

Appendix A: Replacement Parts
The following tables contain all the field-replaceable parts for the EDGE ultrasound system. Quantities are one
unless otherwise noted.
Display
Table A.1: Display
Part Number Description
P15637 Service Assembly, Display, Edge
P15638 Warranty Service Assembly, Display, Edge
V15637 Vet Service Assembly, Display, Edge
V15638 Vet Warranty Service Assembly, Display, Edge
Appendix A: Replacement Parts 67

Control Panel
Table A.2: Control Panel
P15630 Warranty Service Assembly Control Panel, English, Edge
P15631 Warranty Service Assembly Control Panel, French, Edge
P15632 Warranty Service Assembly Control Panel, German, Edge
P15633 Warranty Service Assembly Control Panel, Italian, Edge
P15634 Warranty Service Assembly Control Panel, Spanish, Edge
P15635 Warranty Service Assembly Control Panel, Russian, Edge
P15636 Warranty Service Assembly Control Panel, Portuguese, Edge
P15618 Service Assembly Control Panel, English, Edge
P15621 Service Assembly Control Panel, French, Edge
P15622 Service Assembly Control Panel, German, Edge
P15623 Service Assembly Control Panel, Italian, Edge
P15624 Service Assembly Control Panel, Spanish, Edge
P15625 Service Assembly Control Panel, Russian, Edge
P15626 Service Assembly Control Panel, Portuguese, Edge
68 Appendix A: Replacement Parts

Main PCBA
3 2
Table A.3: Main PCBA
Item Part Number Description
1 P15615 Service Assembly Main PCBA, Edge

P15617 Warranty Service Assembly Main PCBA, Edge
V15615 Vet Service Assembly Main PCBA, Edge
V15617 Vet Warranty Service Assembly Main PCBA, Edge
Note: This part does not include the transducer nest frame assembly. Those
parts must be ordered separately if needed to complete the replacement of the
Main PCBA.
2 P08850 Service Assembly, Power Supply, M-Turbo (compatible with Edge system)
3 P09541 Power Supply Shield
4 P10168 2GB SD Card (requires 4)
5 P07442 SD Card Daughter-card
Not shown P09542 Power Supply Shield Cover. Attaches to Item 3 Power Supply Shield

Miscellaneous Parts
Table A.4: Miscellaneous Parts
Cables (images are not to scale)
P02308 FFC, 12 Position Jumper, 0.5 Pitch, 3” Length (3” Flat Flex Cable)
Note: This cable is used in two locations on the Control Panel PCB.
P14729 Cable Assy, Main to Control Panel PCB, Video
P14747 Cable, Main To Control Panel PCB, Backlight
P15410 FFC, 12 Position, 0.5MM Pitch, Opposite Side (8” Flat Flex Cable)

Other Electrical Parts
P02312 Fan Assembly
P03872 Speaker Assembly
P14727 USB Extension PCB Assy
P14742 Compression Connector Insulator, EDGE (Used with P15723)
P15273 Connector, Compression 166 Wires/Inch, 33.350 (Used with P14742)
P15984 Gasket, EMI/ESD (Used with P15304 - requires 2)

Mechanical/Cosmetic Parts
See Note Bottom Enclosure
Note: Contact SonoSite Technical Support if it is necessary to replace the

bottom enclosure. Ordering the bottom enclosure requires special handling due
to the serial number label.
P09542 Power Supply Shield
P14750 Foot (4x)

P15305 Hinge Cover
P16156 Service Assembly, EDGE Top Enclosure
P15304 Enclosure, Middle, Machined, EDGE
P07885 Thermal Pad, 1.00 x 1.00 x 0.100” (Used with P15304 & P15615 - requires 4)
P07886 Thermal Pad, 0.35 x 0.35 x 0.100” (Used with P15304 & P15615 - requires 4)

Transducer Nest Frame Assembly
7
2 6
5
3
4
Figure A.1 Nest Frame Parts
Table A.5: Nest Frame Assembly
Find Number Part Number Description
1 P07750 Nest Frame Assembly
2 P00364 Connector, Interposer (8x)
3 P03833 Shield, Perimeter, Short (2x)
4 P03834 Shield, Perimeter, Long (2x)
5 P00924 Screw, Shoulder, Thrust Plate (4x)
6 P00353 Wear Plate
not shown P00646 Spring, Thrust Plate, .047 wire (4x)
7 P08200 Socket Head Cap Screw, M2.5-.45x10mm (4x)
Ordering Replacement Parts

To order parts, contact SonoSite Technical Support as indicated in “Contact Information” on page 1.

Appendix B: Service Event Reporting
The Service Event Report provides information about product failures to the manufacturer and to authorized
service facilities, which provide approved warranty services for SonoSite products. For all repairs completed,
complete the form and email a copy of it to service@sonosite.com or mail to the following address:
SonoSite, Inc.
Technical Support
21919 30th Drive SE
Bothell, Washington 98021
USA
To contact SonoSite Technical Support, see“Contact Information” on page 1.
Appendix B: Service Event Reporting 75

Service Event Report Form
Service Event Report Choose a Service Type

Choose a Part Status
Instructions on reverse
Service Type (check one) Parts Status (check one) For SonoSite Use O
No parts necessary for this repair. Service
Out of Box Failure Event Report for your information. Service Request
I need parts for this repair (list the parts below
Warranty Service and attach Purchase Order) Order Number
I need parts to replenish my stock (list the
Out of Warranty Service parts used below and attach Purchase Order) RMA Number
Will not replenish stock. Please give me a
RMA for the return of the faulty parts. Work Order
Enter complete
No parts necessary. Please issue a RMA for
contact information repair at SonoSite.
Service Provider
Name: Provider Reference:
Company: Date Reported:
Address:
Phone Number: Fax Number:
E-mail address:
Enter product information for
Device Description the system being repaired
Ref Number: Serial Number:
Name: Lot Number:
ARM/SHDB Version: Configuration:
Problem Found
Put the system configuration here.
You can find this on the System
Enter DETAILED problem Information Page
Service Performed description here.
Performed By: Date:
Parts Removed
Part Name Part Number Serial Number Lot Number Rev Replace
Enter details for parts being Enter details for parts being
removed from the system. installed into the system.
Parts Installed
Part Name Part Number Serial Number Lot Number Rev Replace
Tests Performed (attach test data)

Test: Test:
76 Appendix B: Service Event Reporting

Service Event Report Instructions
Instructions for completing the Service Event Report

Sections highlighted in yellow must be completed for SonoSite to accept the Service Event Report. If additional information is
required for certain circumstances you will be advised.
Forward the completed form to:
Email: service@sonosite.com
Fax: +1-425-951-6700
Service Type
x Out of Box Failure: the item has arrived from SonoSite with failures.
x Warranty Service: the item has failed after arrival and is covered by either the included warranty or a valid extended
warranty.
x Out of Warranty Service: the item has failed and it is no longer covered by a warranty.
Parts Status
x Check One.
Service Provider
x Name: the name of the technician performing the work.
x Provider Reference: a unique number used by the Provider to track Service Event Reports. Any format is acceptable.
x Company: the name of the Distributor or authorized repair facility.
x Address: the address replacement parts will be shipped to.
x Date Reported: the date the failure was reported to SonoSite.
x Phone Number: the phone number to contact the service technician.
x Fax Number: the fax number to contact the service technician.
x Email Address: the email address to contact the service technician.
Device Description:
x Name: the description of the failed product.
x Ref Number: the reference number from the part number label of the failed product.
x Serial Number: the serial number from the part number label of the failed product.
x Lot Number: if applicable, the Lot Number from the device identification label.
x ARM/SHDB Version: the software level of the failed device. Typically found on the system information screen.
x Configuration: for configurable devices, the optional features enabled.
Event Description
x A description of the problem in the words of the user. Typically what the user reports to the repair facility.
Diagnosis
x A description of what the repair technician found. Include a list of the suspect parts.
Service Performed
x A description of the work performed to repair the system. Typically only completed if it is repaired from stock repair parts.
Parts Removed
x Part Name: the name of the failed/suspect part to be replaced.
x Part Number: the part number of the failed/suspect part.
x Serial Number: the serial number from the failed/suspect part.
x Lot Number: the lot number if applicable.
x Rev: the revision of the failed/suspect part if available.
x Replaced By: the person replacing the part.
Parts Installed
x The same information as the Parts Removed except from the parts installed if work has already been performed. If you are
waiting for parts to be ordered, leave this section blank.
Tests Performed
x The results of any testing performed, if testing has already been performed.
Appendix B: Service Event Reporting 77

Returning Products to SonoSite
You will be asked to provide the following information:
• Contact name and phone number
• Product name
• Serial number
• Description of the problem
Shipping Instructions
Please contact SonoSite to get a return material authorization number (RMA). Contact SonoSite before returning
any product.
The shipping address for all returned products is:
SonoSite, Inc.
Attn: Technical Support RMA ___________________
21919 30th Drive SE
Bothell, Washington 98021
USA
78 Appendix B: Service Event Reporting

INDEX
Numerics
2D performance tests
axial measurement accuracy 61
image quality 61
lateral measurement accuracy 61
penetration 62
A
ALARA 13
assert code 36
assistance, customer 1
B
battery
clean 56
safety 12
specifications 6
battery charging test 65
biological safety 13
bottom enclosure replacement 52
C
cables
clean and disinfect ECG 57
cautions, definition 1
clean
battery 56
ECG cable 57
footswitch 56
LCD screen 54
system 54
transducers 55
cleaners, recommended 53
control panel subassembly replacement 44
D
disinfect
battery 56
ECG cable 57
system 54
transducers 55
disinfectants, recommended 53
display removal 39
display replacement 39, 43
E
electrical
safety 9
specifications 5
electromagnetic compatibility 14
equipment safety 11
error message 10
F
failure reporting 75
79
H
humidity limits 5
I
image
quality verification test 64
review 65
L
LCD screen
clean 54
M
main PCBA
failures 36
main system disassembly 45
middle machined enclosure 52
P
performance tests
2D 60
battery 65
CPD 63
CW 64
M-Mode 63
overview 59
printer 65
PW 64
THI 63
Velocity Color 62
video output 65
periodic maintenance 53
power supply PCBA replacement 48
pressure limits 5
printer
test 65
product failures 75
R
replacement parts
list 67
ordering 74
return material authorization number (RMA) 78
returning products 78
S
safety
battery 12
biological 13
electrical 9
electromagnetic compatibility 14
equipment 11
SD card daughter-card replacement 49
service event report 75
shipping instructions 78
shipping specifications 5
speaker replacement 47
80
storage specifications
equipment 5
subassembly replacement 35
system
clean and disinfect 54
measurement accuracy 61
overview 21
T
temperature limits 5
theory of operation 22
transducer
clean and disinfect 55
disinfect 55
U
USB extension PCB replacement 50
user guide, conventions used 1
V
video output tests 65
W
warnings, definition 1
81
82
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Service Manual

System Overview .............................................................................. 21

Replacement Procedures ................................................................. 39

Performance Testing ........................................................................ 59

Service Event Reporting................................................................... 75

Technical Support (USA, Canada) 1-877-657-8118

Technical Support fax: 1-425-951-6700

Technical Support e-mail: service@sonosite.com

SonoSite website: www.sonosite.com (Select Resources > Support & Service)

European Service Center +44-(0)1462-444-800

Japan Service Center +81-3-5304-5337

Conventions, symbols, and terms

Class 1 device indicating manufacturer’s declaration of conformance with Annex

Class 1 device requiring verification by the Notified Body of sterilization or

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

Device complies with relevant Brazilian regulations for electro-medical devices.

REF Catalog number

Collect separately from other household waste (see European Commission

Direct Current (DC)

Do not get wet.

Do not stack over 2 high.

Do not stack over 5 high.

Do not stack over 10 high.

Electrostatic sensitive devices

Device complies with relevant FCC regulations for electronic devices.

Sterilized using irradiation

STERILE EO Sterilized using ethylene oxide

Device emits a static (DC) magnetic field.

SN Serial number type of control number

Atmospheric pressure limitation

Submersible. Protected against the effects of temporary immersion.

Water-Tight Equipment. Protected against the effects of extended immersion.

Handle transducer with care.

Follow manufacturer’s instructions for disinfecting time.

Type BF patient applied part

Defibrillator proof type CF patient applied part

Underwriter’s Laboratories labeling

Operating (system, battery, and transducer)

Shipping and storage (system and transducer)

Shipping and storage (battery)

Compatible accessories and peripherals

Accessories and peripherals compatible with Edge ultrasound system

Description Part Number Maximum Cable Length

C8 transducer P08010 6.0 ft/1.8 m

C11x transducer P07678 6.5 ft/2.0 m

C60x transducer P07680 6.0 ft/1.8 m

D2x transducer P05165 6.0 ft/1.8 m

HFL38x transducer P07682 6.0 ft/1.8 m

HFL50x transducer P07693 6.0 ft/1.8 m

ICTx transducer P07690 6.0 ft/1.8 m

L25x transducer P07691 8.0 ft/2.4 m

L38xi transducer P12742 6.0 ft/1.8 m

L52x transducer (Vet) V00033 7.9 ft/2.4 m

P10x transducer P07696 6.5 ft/2.0 m

P21x Transducer P07698 6.5 ft/2.0 m

SLAx transducer P07699 8.0 ft/2.4 m

TEEx Transducer P05183 7.5 ft/2.3 m