Fujifilm SonoSite Edge II Service manual

Manufacturer FUJIFILM 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

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

Caution:

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.

Federal (United States) law restricts this device to sale by or on the order of a physician.

iii

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

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

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

vii

viii

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: 1-425-951-6700

Technical Support e-mail: ffss-service@fujifilm.com

SonoSite website: www.sonosite.com

International Technical Support: Contact your local representative or call (USA) +425-951-1330

European Service Center United Kingdom

Tel: 0044 01462341151 e-mail: uk-service@fujifilm.com

France Tel: 0033 01/82880702 e-mail: ERAF-service@fujifilm.com

Germany Tel: 0049 069/80884030 e-mail: ERAF-service@fujifilm.com

Spain Tel: 0034 911238451 e-mail: ERAF-service@fujifilm.com

Italy Tel 0039 02 94753655 e-mail: ERAF-service@fujifilm.com

Asia/Pacific Tel: (+65) 63805581

e-mail: FFSS-APACME-service@fujifilm.com

Chapter 1: Introduction 1

Conventions, symbols, and terms

LOT

REF

The user guide follows these conventions:

•A WARNIN G 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.

2 Chapter 1: Introduction

Table 1: Labeling Symbols (Continued)

STERILE R

STERILE EO

Symbol Definition

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

Chapter 1: Introduction 3

Table 1: Labeling Symbols (Continued)

Symbol Definition

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.

4 Chapter 1: Introduction

Table 1: Labeling Symbols (Continued)

Symbol Definition

WARNING: Connect Only

Accessories and Peripherals

Recommended by FujiFilm SonoSite

WARNING: Connect Only Accessories and Peripherals Recommended by FujiFilm SonoSite

Chapter 1: Introduction 5

6 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 7

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:

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

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.

Use of accessories other than those specified may result in increased emissions or decreased immunity of the ultrasound system.

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

8 Chapter 2: Specifications

Accessories and peripherals compatible with SonoSite Edge II ultrasound system (Continued)

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

— 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 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

P22048

stands

Triple Transducer Connect P16535 —

USB wireless adapter P17725 —

EU compliant wireless adapter P22625

Edge Battery Pack P15051 —

Wireless mounting kit P17724

Chapter 2: Specifications 9

10 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 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.

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.

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

Chapter 3: Safety 11

• 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:

Caution:

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.

To prevent injury to the operator/bystander, the transducer must be removed from patient contact before the application of a high-voltage defibrillation pulse.

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)).

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.

12 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

Type BF applied parts Ultrasound transducers

Type CF applied parts ECG module/ECG leads

IPX-7 (watertight equipment)

IPX-8 (watertight equipment)

Non AP/APG Ultrasound system power supply, docking system, and

Ultrasound system not connected to the power supply (battery only)

Ultrasound transducers

Footswitch

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.

Improper cleaning or disinfecting of any part of the system can cause permanent damage. For cleaning and disinfecting instructions, see Chapter 7,

“Maintenance”.

Caution:

Chapter 3: Safety 13

Do not submerge the transducer connector in solution. The cable is not liquid-tight beyond the transducer connector/cable interface.

Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of the system.

Remove the battery from the system if the system is not likely to be used for a month or more.

Do not spill liquid on the system.

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.

Charge the batteries only when the ambient temperature is between 0° and 40°C (32° and 104°F).

Do not short-circuit the battery by directly connecting the positive and negative terminals with metal objects.

Do not touch battery contacts.

Do not heat the battery or discard it in a fire.

Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire and other heat sources.

Do not charge the battery near a heat source, such as a fire or heater.

Do not leave the battery in direct sunlight.

Do not pierce the battery with a sharp object, hit it, or step on it.

Do not use a damaged battery.

Do not solder a battery.

The polarity of the battery terminals isfixed and cannot be switched or reversed. Do not force the battery into the system.

Do not connect the battery to an electrical power outlet.

Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles.

WARNING:

Caution:

Do not ship a damaged battery without instructions from SonoSite Technical Support. (See “Technical Support (USA, Canada)” on page 1.)

If the battery leaks or emits an odor, remove it from all possible flammable sources.

Periodically check to make sure that the battery charges fully. If the battery fails to charge fully, replace it.

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.

14 Chapter 3: Safety

Clinical safety

WARNING:

Non-medical (commercial) grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis.

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.

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.

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.

Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable) principle and follow the prudent use information concerning MI and TI.

SonoSite does not currently recommend a specific brand of acoustic standoff. If an acoustic standoff is used, it must have a minimum attenuation of .3dB/cm/MHz.

Some SonoSite transducers are approved for intraoperative applications if a market-cleared sheath is used.

To avoid injury and reduce 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 or P21x needle guide bracket on patients with pacemakers or medical electronic implants. The needle guide bracket for the P10x 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:

Chapter 3: Safety 15

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.

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:

Caution:

The Sonosite Edge II ultrasound system should not be used adjacent to or stacked with other equipment. If such use occurs, verify that the SonoSite Edge II ultrasound system operates normally in that configuration.

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:

16 Chapter 3: Safety

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

PPP

Recommended separation distances between portable and mobile RF communications equipment and the SonoSite Edge II ultrasound system

The SonoSite Edge II 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 SonoSite Edge II ultrasound system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SonoSite Edge II ultrasound system as recommended below, according to the maximum output power of the communications equipment.

Rated

maximum output power of transmitter

Watts

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

11.2 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.

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

d=1.2

80 MHz to 800 MHz

d=1.2

800 MHz to 2.5 GHz

d=2.3

Chapter 3: Safety 17

Guidance and manufacturer’s declaration

WARNING:

The SonoSite Edge II wireless adapter 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 SonoSite Edge II ultrasound system is intended for use in the electromagnetic environment specified below. The customer or the user of the SonoSite Edge II ultrasound system should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment

RF emissions ClSPR 11

Other equipment, even equipment that complies with CISPR emission requirements, can interfere with the SonoSite Edge II ultrasound system.

Group 1 The SonoSite Edge II ultrasound system uses RF

energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions ClSPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/flicker emissions

IEC 61000-3-3

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test

Electrostatic Discharge (ESD)

IEC 61000-4-2

IEC 60601 Test Level

±6.0KV contact ±8.0KV air

Class A The SonoSite Edge II ultrasound system is

suitable for use in all establishments other than domestic and those directly connected to the

Class A

Complies

public low-voltage power supply network which supplies buildings used for domestic purposes.±

Compliance Level

±6.0KV contact ±8.0KV air

Electromagnetic Environment

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

18 Chapter 3: Safety

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

Immunity Test

Electrical fast Transient burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

IEC 60601 Test Level

±2KV for power supply lines

±1KV for input/output lines

±1KV line(s) to line(s)

±2KV line(s) to earth

>5% U

(>95% dip in UT) for

0.5 cycle 40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycles >5% U

(>95% dip in UT) for 5s

Compliance Level

±2KV for power supply lines

±1KV for input/output lines

±1KV line(s) to line(s)

±2KV line(s) to earth

>5% U

(>95% dip in UT) for 0.5 cycle 40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycles >5% U

(>95% dip in UT) for 5s

Electromagnetic Environment

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SonoSite Edge II ultrasound system requires continued operation during power mains interruptions, it is recommended that the SonoSite Edge II ultrasound system be powered from an uninterruptible power supply or a battery.

Power Frequency Magnetic Field

IEC 61000-4-8

Conducted RF IEC 61000-4-6

3 A/m 3 A/m Power frequency magnetic

fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

3Vrms 150 kHz to 80 MHz

3 Vrms Portable and mobile RF

communications equipment should be used no closer to any part of the SonoSite Edge II 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

Chapter 3: Safety 19

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

Immunity Test

Radiated RF IEC 61000-4-3

Radiated RF IEC 61000-4-3 (continued)

IEC 60601 Test Level

3Vim 80 MHz to 2.5 GHz

Compliance Level

3 V/m

Electromagnetic Environment

d = 1.2 80 MHz to 800 MHz

d = 2.3 800 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).

Field strengths from fixed RF transmitters, as determined by an electromagnetic Site

survey

, should be less than

the compliance level in each

frequency range

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.

20 Chapter 3: Safety

Immunity testing requirements

The SonoSite Edge II 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 SonoSite Edge II 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 ES60601-1:2005 + C1(2009) + A2(2010) Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (3

edition plus Corrigendum 1 and Amendment A2)

CSA C22.2 No. 60601-1-08 + TC 2(2011) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (3

IEC 60601-1:2005 + C1(2006) + C2(2007) Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (3

CSA C22.2 60601-2-37:08 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment

IEC 60601-2-37 (ed .2.0) Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment

CSA C22.2 60601-6-07 Medical Electrical Equipment part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability

IEC 60601-1-6:2010 Medical Electrical Equipment part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability.

edition plus Corrigendum 2)

edition plus Corrigendum 1 and Corrigendum 2)

EMC standards classification

CISPR 11:2009, Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance Characteristics—Limits and Methods of Measurement.

IEC 60601-1-2:2007, Medical Electrical Equipment—General Requirements for Basic Safety and Essential Performance-Collateral Standard. Electromagnetic Compatibility Requirements and Tests.

The Classification for the ultrasound system, docking system, accessories, and peripherals when configured together: Group 1, Class A.

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).

Chapter 3: Safety 21

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