FujiFilm SonoSite Edge II User manual

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

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

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

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

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

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

Chapter 1: Introduction 3
Corrugated recycle
Dangerous voltage
Date of manufacture
Manufacturer
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.
Fragile
GEL Gel
Sterilized using irradiation
Sterilized using ethylene oxide
Hot
Table 1: Labeling Symbols (Continued)
Symbol Definition
STERILE R
STERILE EO

4Chapter 1: Introduction
Device emits a static (DC) magnetic field.
Non-ionizing radiation
Paper recycle
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.
Table 1: Labeling Symbols (Continued)
Symbol Definition
SN

Chapter 1: Introduction 5
WARNING:
Connect Only
Accessories and
Peripherals
Recommended
by FujiFilm
SonoSite
WARNING: Connect Only Accessories and Peripherals Recommended by
FujiFilm SonoSite
Table 1: Labeling Symbols (Continued)
Symbol Definition

6Chapter 1: Introduction

Chapter 2: Specifications 7
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.

8Chapter 2: Specifications
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.
Compatible accessories and peripherals
SonoSite has tested the SonoSite Edge II 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 SonoSite Edge II ultrasound
system.
WARNING: Use of the accessories with medical systems other than the SonoSite
Edge II 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 SonoSite Edge II ultrasound system
Description Part Number Maximum Cable Length
C8x transducer P08010 6.0 ft/1.8 m
C11x transducer P07678 6.5 ft/2.0 m
C35x transducer P21981 6.0 ft/1.8 m
rC60xi transducer P21070 5.5 ft/1.7 m
rC60xi transducer armored P21636 5.5 ft/1.7 m
rP19x transducer P21015 6.0 ft/1.8 m
rP19x transducer armored P21556 6.0 ft/1.8 m
HFL38xi transducer P20311 5.5 ft/ 1.7 m
HFL38xi transducer armored P20377 5.5 ft/1.7 m
HFL50x transducer P07693 6.0 ft/1.8 m
HSL25x P20679 7.5 ft/2.3 m
ICTx transducer P07690 6.0 ft/1.8 m
L25x transducer P07691 7.5 ft/2.3 m
L25x transducer armored P22950 7.5 ft/2.3 m
L38xi transducer P12742 6.0 ft/1.8 m
L38xi transducer armored P19626 6.0 ft/1.8 m
L52x transducer (Vet) V00033 7.5 ft/2.3 m
L52x transducer armored (Vet) V20962 7.5 ft/2.3 m
P10x transducer P07696 6.5 ft/2.0 m
TEExi transducer P19825 7.5 ft/2.3 m

Chapter 2: Specifications 9
Bar code scanner P14166 4.8 ft/1.5 m
Kit, PowerPack P13559 —
Black & white printer P13745 —
Hybrid black & white printer P20006
Black & white printer power
cable
— 3.3 ft/1 m
Black & white printer USB
cable
— 10.8 ft/3.3 m
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 Mini-Dock P15078 —
Edge Stand P15800 —
Dual USB Footswitch P14689 9.8 ft/3.0 m
Power cord (system) P00848 (USA) 10 ft/3 m
Power Supply/Battery Charger P09823 6.8 ft/ 2 m
PowerPark P12822 —
Storage bin kit, Universal/Edge
stands
P22048
Triple Transducer Connect P16535 —
USB wireless adapter P17725 —
EU compliant wireless adapter P22625
Edge Battery Pack P15051 —
Wireless mounting kit P17724
Accessories and peripherals compatible with SonoSite Edge II ultrasound system (Continued)

10 Chapter 2: Specifications

Chapter 3: Safety 11
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 21.
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

12 Chapter 3: Safety
• 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.
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 LCD display. Note
the error code and call SonoSite Technical Support for further assistance.
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.