EDGE Service Manual June 2012

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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

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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:

[email protected]

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: [email protected]

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.

LOT

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.

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.

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

STERILE R STERILE EO

Gel Sterilized using irradiation

Sterilized using ethylene oxide Hot Device emits a static (DC) magnetic field.

Non-ionizing radiation

Paper recycle

Chapter 1: Introduction

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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: Connect Only Accessories and Peripherals Recommended by SonoSite

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Chapter 1: Introduction

WARNING: Connect Only Accessories and Peripherals Recommended by SonoSite

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

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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

-

Chapter 2: Specifications

Accessories and peripherals compatible with Edge ultrasound system (Continued) 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 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

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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

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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.

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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.

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

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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.

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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.

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.

Chapter 3: Safety

13