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SONIX CEP ULTRASOUND SYSTEM SERVICE MANUAL

CEP Service Manual 00.053.008, Revision B

Ultrasonix Medical Corporation

SONIX CEP Ultrasound System Service Manual

Ultrasonix Medical Corporation 130 – 4311 Viking Way Richmond, BC V6V 2K9 Canada

www.ultrasonix.com

1.866.437.9508

© 2007 Ultrasonix Medical Corporation 00.053.008, Revision B, April 17, 2007 All rights Reserved. Printed in Canada

US Patents 6,911,008 – 6,558,326 – 6,325,759

CEP Service Manual 00.053.008, Revision B Table of Contents

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Table of Contents

CHAPTER 1: GENERAL INFORMATION........................................................................................................................... 1 1.1 AUDIENCE ................................................................................................................................................................... 1 1.2 CONNECTIVITY DISCLAIMER .................................................................................................................................... 1 1.3 LICENSE AGREEMENT............................................................................................................................................... 1 1.4 CEP AND E-MED SOFTWARE.................................................................................................................................... 2 1.5 TRADEMARKS AND PATENTS................................................................................................................................... 2 1.6 INTRODUCTION .......................................................................................................................................................... 3 1.7 PHYSICAL DESCRIPTION .......................................................................................................................................... 4

1.7.1 LCD Display ..................................................................................................................................................... 4 1.7.2 Console ............................................................................................................................................................ 4 1.7.3 Ultrasound Modulo ........................................................................................................................................... 4 1.7.4 Transducers ..................................................................................................................................................... 4 1.7.5 UPS.................................................................................................................................................................. 4

CHAPTER 2: SYSTEM SPECIFICATIONS......................................................................................................................... 5 2.1 DIMENSION ................................................................................................................................................................. 5 2.2 SYSTEM ARCHITECTURE.......................................................................................................................................... 5 2.3 IMAGING MODES........................................................................................................................................................ 5 2.4 CLINICAL APPLICATIONS .......................................................................................................................................... 6 2.5 TRANSDUCERS .......................................................................................................................................................... 6 2.6 IMAGE PARAMETER ADJUSTMENTS ....................................................................................................................... 7

2.6.1 B Mode ............................................................................................................................................................. 7 2.6.2 M Mode ............................................................................................................................................................ 7 2.6.3 Pulsed Wave Doppler....................................................................................................................................... 7 2.6.4 Color/Power Doppler ........................................................................................................................................ 7

2.7 CLINICAL ANALYSIS................................................................................................................................................... 8 2.8 IMAGE STORAGE...................................................................................................................................................... 10 2.9 SYSTEM BOOT POWER ........................................................................................................................................... 10 2.10 EXTERNAL CONNECTIONS ..................................................................................................................................... 11 2.11 UI LANGUAGES (SELECTABLE) .............................................................................................................................. 11 2.12 ADDITIONAL SOFTWARE FEATURES..................................................................................................................... 11 2.13 ADDITIONAL HARDWARE FEATURES .................................................................................................................... 12 2.14 ELECTRICAL RATINGS............................................................................................................................................. 12 2.15 VOLTAGE................................................................................................................................................................... 12

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CHAPTER 3: SYSTEM INSTALLATION...........................................................................................................................13 3.1 PRE-INSTALLATION PROCEDURE..........................................................................................................................13

3.1.1 Environmental Requirements..........................................................................................................................13 3.1.2 Electrical Requirements..................................................................................................................................14

3.1.2.1 Instrument Input Power Rating .......................................................................................................14 3.1.3 Electrostatic Discharge ...................................................................................................................................15 3.1.4 Electromagnetic and Radio Frequency Interference.......................................................................................16 3.1.5 Wiring Requirements ......................................................................................................................................20

3.1.5.1 Main AC Connection.......................................................................................................................20 3.1.5.2 Ethernet (Hard-Wired) Network Connection ...................................................................................20 3.1.5.3 Image Management Network..........................................................................................................20

3.2 SYSTEM INSTALLATION...........................................................................................................................................21 3.2.1 Preliminary Inspection ....................................................................................................................................21 3.2.2 Uncrating Instructions .....................................................................................................................................22 3.2.3 Mounting the Arm for the LCD Display ...........................................................................................................24 3.2.4 Mounting the LCD Display ..............................................................................................................................26 3.2.5 System Case Connectivity Panel Check.........................................................................................................27 3.2.6 Back Connectivity Panel .................................................................................................................................29 3.2.7 Front Console Connectivity.............................................................................................................................29 3.2.8 Rear Console Connectivity (CEP Barcode Reader)........................................................................................30 3.2.9 Fuses..............................................................................................................................................................30 3.2.10 Changing Fuses..............................................................................................................................................31 3.2.11 UPS ................................................................................................................................................................32

3.2.11.1 Powering the UPS ON and OFF.....................................................................................................33 3.2.12 Connecting the Barcode Reader.....................................................................................................................34 3.2.13 CEP ................................................................................................................................................................34

3.2.13.1 SONIX OP/SP ................................................................................................................................35 3.2.14 Unwinding/Retracting the Power Cord (CEP) .................................................................................................35 3.2.15 Wireless Connection.......................................................................................................................................37 3.2.16 Final Inspection...............................................................................................................................................39

CHAPTER 4: PERFORMANCE TESTING ........................................................................................................................41 4.1 INTRODUCTION ........................................................................................................................................................41 4.2 CONSOLE TEST ........................................................................................................................................................41 4.3 IMAGE TEST ..............................................................................................................................................................42 4.4 COMMUNICATION TEST (HARD-WIRED) ................................................................................................................43

4.4.1 LAN Communication Test (Hard-Wired) .........................................................................................................43 4.4.2 Dialup Communication Test (Hard-Wired) ......................................................................................................44

4.5 COMMUNICATION TEST (WIRELESS).....................................................................................................................45 4.6 REMOVABLE HARDWARE TEST..............................................................................................................................47 4.7 HARDWARE TEST.....................................................................................................................................................47 4.8 MECHANICAL TEST ..................................................................................................................................................47 4.9 UPS TEST ..................................................................................................................................................................48

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CHAPTER 5: SOFTWARE................................................................................................................................................ 49 5.1 SOFTWARE MODES ................................................................................................................................................. 49 5.2 SOFTWARE UPDATE VIA THE INTERNET .............................................................................................................. 49 5.3 SOFTWARE UPDATE USING A CD.......................................................................................................................... 49 5.4 SYSTEM RECOVERY................................................................................................................................................ 50

CHAPTER 6: CONNECT PERIPHERALS ........................................................................................................................ 51 6.1 B&W/COLOR THERMAL PHOTO PRINTER OR VCR .............................................................................................. 51 6.2 REMOTE TRIGGER................................................................................................................................................... 52 6.3 INKJET OR LASER PRINTER SETUP....................................................................................................................... 53

6.3.1 Local Printer Setup: HP DeskJet 5440 ........................................................................................................... 53 6.3.2 Network Printer Setup: HP DeskJet 5440....................................................................................................... 56 6.3.3 Image Sheet Printing ...................................................................................................................................... 58

CHAPTER 7: COMPONENTS AND ASSEMBLY............................................................................................................. 59 7.1 INTRODUCTION ........................................................................................................................................................ 59 7.2 ASSEMBLY DRAWINGS............................................................................................................................................ 59

7.2.1 Console Assembly.......................................................................................................................................... 59 7.2.2 Module Assembly ........................................................................................................................................... 62 7.2.3 Cart Assembly ................................................................................................................................................ 64

7.3 ELECTRICAL COMPONENTS................................................................................................................................... 68 7.3.1 Cable Components......................................................................................................................................... 70 7.3.2 Peripheral Components.................................................................................................................................. 75 7.3.3 Transducers ................................................................................................................................................... 75

CHAPTER 8: FIELD SERVICE COMPONENTS............................................................................................................... 77 8.1 INTRODUCTION ........................................................................................................................................................ 77 8.2 LCD DISPLAY SERVICING........................................................................................................................................ 77

8.2.1 Removing the Liquid Crystal Display (LCD) Display....................................................................................... 77 8.2.2 Installing the Liquid Crystal Display (LCD) Display......................................................................................... 78 8.2.3 Replacing the LCD Display Cables (SX3.0) ................................................................................................... 79

8.3 CONSOLE SERVICING ............................................................................................................................................. 83 8.3.1 Removing the Console ................................................................................................................................... 83 8.3.2 Installing the Console ..................................................................................................................................... 85

8.4 ULTRASOUND MODULO SERVICING...................................................................................................................... 86 8.4.1 Back-up User Data/Presets (as required)....................................................................................................... 86 8.4.2 Back-up Patient Data (as required) ................................................................................................................ 87 8.4.3 Removing the Rear Shroud (Accessing the System Case) ............................................................................ 88 8.4.4 Removing the Ultrasound Modulo .................................................................................................................. 89 8.4.5 Installing the Ultrasound Modulo .................................................................................................................... 91 8.4.6 Removing the Front Block .............................................................................................................................. 93 8.4.7 Replacing the Front Block .............................................................................................................................. 94 8.4.8 Replacing the Rear Shroud ............................................................................................................................ 96 8.4.9 Transferring User Settings.............................................................................................................................. 97 8.4.10 Re-Import License.Key (If Required) .............................................................................................................. 98


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8.5 REPLACING THE SPEAKER POWER CABLE..........................................................................................................98 8.6 REPLACING THE MODEM ........................................................................................................................................99 8.7 UPS SERVICING......................................................................................................................................................100

8.7.1 Shipping the UPS for Service/Repair/Replacement......................................................................................100 8.7.2 Removing/Replacing the UPS ......................................................................................................................101

8.8 BARCODE READER SERVICING............................................................................................................................103 8.9 RETRACTABLE POWER CORD (CABLE REEL) SERVICING................................................................................103

8.9.1 Attaching/Detaching the Cable Reel .............................................................................................................104 8.10 TRANSDUCER SERVICING ....................................................................................................................................105

8.10.1 Testing the Transducer.................................................................................................................................105 8.10.2 Testing the Transducer Board ......................................................................................................................105

8.11 TRANSDUCER MAINTENANCE..............................................................................................................................106 8.11.1 Guidelines.....................................................................................................................................................106 8.11.2 Ultrasound Coupling Gels.............................................................................................................................106 8.11.3 Cleaning/Disinfecting Recommendations and Warnings for all Non-Invasive Transducers..........................107

8.11.3.1 Cleaning (Non-Invasive Transducers) ..........................................................................................108 8.11.3.2 Disinfecting (Non-Invasive Transducers)......................................................................................108 8.11.3.3 Sterilization (Non-Invasive Transducers)......................................................................................108 8.11.3.4 Maintenance (Non-Invasive Transducers)....................................................................................109 8.11.3.5 Inspection and Testing (Non-Invasive Transducers) ....................................................................109 8.11.3.6 Storing and Packaging (Non-Invasive Transducers) ....................................................................110

8.11.4 Cleaning/Disinfecting Recommendations and Warnings for all Invasive Transducers..................................110 8.11.4.1 Cleaning (Invasive Transducers) ..................................................................................................111 8.11.4.2 Disinfecting (Invasive Transducers)..............................................................................................111 8.11.4.3 Sterilization (Invasive Transducers)..............................................................................................111 8.11.4.4 Maintenance (Invasive Transducers)............................................................................................112 8.11.4.5 Inspection and Testing (Invasive Transducers) ............................................................................112 8.11.4.6 Storing and Packaging (Invasive Transducers) ............................................................................113

8.11.5 Shipping Transducers for Service.................................................................................................................113 CHAPTER 9: DICOM CONFIGURATION........................................................................................................................115

9.1 DICOM STORAGE CONFIGURATION ....................................................................................................................116 9.2 DICOM PRINT CONFIGURATION ...........................................................................................................................121 9.3 DICOM WORKLIST CONFIGURATION ...................................................................................................................126

CHAPTER 10: NETWORK CONNECTION .....................................................................................................................129 10.1 SETTING UP THE NETWORK.................................................................................................................................129

10.1.1.1 Wireless Settings..........................................................................................................................130 10.2 REMOTE SUPPORT ................................................................................................................................................131

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CHAPTER 11: LICENSE.KEY IMPORTATION .............................................................................................................. 133 11.1 INTRODUCTION ...................................................................................................................................................... 133 11.2 RE-IMPORT LICENSE.KEY FROM AN EXTERNAL SOURCE ............................................................................... 133 11.3 RE-IMPORT LICENSE.KEY FROM A LOCAL DRIVE ............................................................................................. 134

CHAPTER 12: COMPLETE PLASTICS REPLACEMENT ............................................................................................. 135 12.1 INTRODUCTION ...................................................................................................................................................... 135 12.2 REAR PLASTIC COVER REMOVAL (REMOVING THE REAR SHROUD) ............................................................. 135 12.3 CONSOLE SUPPORT PLASTICS REMOVAL ......................................................................................................... 136

12.3.1 Inner Console Support and Console Assembly Plastics Removal................................................................ 136 12.3.2 Outer Console Support Plastic Removal ...................................................................................................... 138

12.4 LCD DISPLAY TOWER PLASTICS REMOVAL ....................................................................................................... 139 12.5 SPEAKER REMOVAL .............................................................................................................................................. 140 12.6 BODY PLASTICS REMOVAL................................................................................................................................... 142

CHAPTER 13: MAINTENANCE...................................................................................................................................... 147 13.1 SONIX CEP SYSTEM CLEANING ........................................................................................................................... 147

13.1.1 LCD Display ................................................................................................................................................. 147 13.1.2 Touch Screen ............................................................................................................................................... 148 13.1.3 Operator Console ......................................................................................................................................... 148 13.1.4 Fans ............................................................................................................................................................. 148 13.1.5 Transducers ................................................................................................................................................. 149 13.1.6 UPS (Front Panel Only)................................................................................................................................ 149 13.1.7 Barcode Reader ........................................................................................................................................... 149 13.1.8 Retractable Power Cord ............................................................................................................................... 150 13.1.9 Wireless Adapter .......................................................................................................................................... 150 13.1.10 Transducer Basket ....................................................................................................................................... 150

13.2 RECOMMENDED FREQUENCY OF MAINTENANCE PROCEDURES .................................................................. 151 13.2.1 Transducers ................................................................................................................................................. 151 13.2.2 Handling Transducers .................................................................................................................................. 152


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APPENDIX A: TROUBLESHOOTING............................................................................................................................. A-1 A.1 SYSTEM NOT POWERING UP................................................................................................................................ A-1 A.2 NO PRIMARY HARD DRIVE DETECTED................................................................................................................ A-1 A.3 SONIX MACHINE SEEMS SLOW ............................................................................................................................ A-2

A.3.1 Possible DICOM Issues................................................................................................................................ A-2 A.4 CD/DVD DRIVE NOT RECOGNIZED....................................................................................................................... A-3 A.5 CD/DVD BACKUPS FAILING ................................................................................................................................... A-3 A.6 REGEDIT.................................................................................................................................................................. A-4 A.7 HARDWARE TEST SOFTWARE.............................................................................................................................. A-5 A.8 LCD DISPLAY IS BLANK, TOUCH SCREEN DISPLAYS CORRECTLY ................................................................. A-7

A.8.1 Check the LCD Display Power Source ......................................................................................................... A-7 A.9 LCD DISPLAY BLANK, TOUCH SCREEN DISPLAYS ULTRASONIX LOGO ONLY............................................... A-8 A.10 LCD DISPLAY WORKS, BUT TOUCH SCREEN STILL DISPLAYS ULTRASONIX LOGO

EVEN IN IMAGING MODE ....................................................................................................................................... A-8 A.11 SONIX DOES NOT BOOT, ERROR IS DISPLAYED ON THE LCD DISPLAY....................................................... A-10 A.12 SONIX FREEZES DURING USE............................................................................................................................ A-10 A.13 ELECTRONICS INITIALIZATION FAILURE ........................................................................................................... A-10 A.14 MEMORY TESTS FAILURE (AT INITIALIZATION) ................................................................................................ A-10

A.14.1 Failed PCI Registry Test............................................................................................................................. A-10 A.14.2 Failed PCI Memories Test .......................................................................................................................... A-11 A.14.3 Failed PCI Fifo Test .................................................................................................................................... A-11 A.14.4 Failed Tx Sequencer Test........................................................................................................................... A-11 A.14.5 Failed Tx Memories Test ............................................................................................................................ A-11 A.14.6 Failed Prepro Sequencer Test .................................................................................................................... A-11 A.14.7 Failed Power Test....................................................................................................................................... A-11

A.15 CONNECTING TO CONSOLE FAILURE (AT INITIALIZATION) ............................................................................ A-11 A.16 ONLINE SUPPORT FAILURE (AT INITIALIZATION) ............................................................................................. A-12 A.17 MRU DONGLE OR KEY NOT FOUND................................................................................................................... A-12

CEP Service Manual 00.053.008, Revision B Chapter 1: General Information

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CHAPTER 1: GENERAL INFORMATION

1.1 AUDIENCE

The intended audience of this service manual is properly trained field and in-house service personnel. The SONIX CEP Ultrasound System is a medical device containing several circuit boards, extensive service diagnostics, and complex operating software. For these reasons, Ultrasonix recommends that only trained certified technical support representatives service this ultrasound system.

1.2 CONNECTIVITY DISCLAIMER

Caution: The SONIX CEP networking options are intended for use inside your organization's firewall. Organizations that elect to configure/use the networking functionality provided by Ultrasonix are assuming all liabilities and risks associated with that decision.

Caution: For details on FCC regulations as they apply to the wireless adapter, please refer to the

manufacturer's User's Guide included with the system.

1.3 LICENSE AGREEMENT

All SONIX computer programs have been patented by Ultrasonix Medical Corporation (Ultrasonix). Such programs are licensed under the following software license agreement:

Ultrasonix, or its suppliers, retain(s) ownership of and title to any computer program supplied with the Equipment and to the trade secrets embodied in such computer programs. Subject to the Buyer’s acceptance and fulfillment of the obligations in this paragraph, Ultrasonix grants the Buyer a personal, non-transferable, perpetual, non-exclusive license to use any computer program supplied with the Equipment that is necessary to operate the Equipment solely on the medium in which such program is delivered for the purpose of operating the Equipment in accordance with the instructions set forth in the operator’s manuals supplied with the Equipment and for no other purpose whatsoever. Buyer may not reverse - assemble, reverse - compile or otherwise reverse - engineer such computer programs nor may Buyer make a copy of such program or apply any techniques to derive the trade secrets embodied therein. In the event of a failure by Buyer to comply with the terms of this license, the license granted by this paragraph shall terminate. Further, because unauthorized use of such computer programs will leave Ultrasonix without an adequate remedy at law, Buyer agrees that injunctive or other equitable relief will be appropriate to restrain such use, threatened or actual. Buyer further agrees that (i) any of the Ultrasonix suppliers of software is a direct and intended beneficiary of this end-user sublicense and may enforce it directly against Buyer with respect to software supplied by such supplier, and (ii) NO SUPPLIER OF ULTRASONIX SHALL BE LIABLE TO BUYER FOR ANY GENERAL, SPECIAL, DIRECT, INDIRECT, CONSEQUENTIAL INCIDENTAL OR OTHER DAMAGES ARISING OUT OF THE SUBLICENSE OF THE COMPUTER PROGRAMS SUPPLIED WITH THE EQUIPMENT.

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1.4 CEP AND E-MED SOFTWARE

CEP is the emergency ultrasound hardware platform of the SONIX series system while E-Med is the software that controls emergency ultrasound functionality. Because E-Med is available on the SONIX OP and SP platforms – minus some of the CEP hardware-specific options – the terms are not interchangeable. Refer to Appendix B in the SONIX CEP User Manual for a listing of the various platform options.

Note: E-Med software is only available on the SONIX OP/SP hardware platforms if an E-Med license was purchased and activated.

1.5 TRADEMARKS AND PATENTS

Ultrasonix SONIX systems are protected under US patents 6,911,008 - 6,558,326 - 6,325,759.

Windows© is a trademark of Microsoft Corporation.

DICOM® is the registered trademark of the National Electrical Manufacturers Association (NEMA) for its standards publications relating to digital communications of medical information.

All other products and brand names mentioned in this document are trademarks of their respective companies.

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1.6 INTRODUCTION

The SONIX CEP Ultrasound System is a software driven, ergonomic, diagnostic medical device. It uses state of the art technologies to acquire, process and display ultrasound data (Figure 1-1).

The system has five (5) major field serviceable components: LCD display, Console, Ultrasound Modulo, Transducers and UPS.

Figure 1-1: SONIX CEP Ultrasound System

LCD Display

Operator Console

Transducers

Ultrasound Modulo

Uninterruptible Power System (UPS)

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1.7 PHYSICAL DESCRIPTION

1.7.1 LCD Display

The monitor is an EIZO Liquid Crystal Display. Operating resolution is 1024x768 pixels @ 60Hz (Hertz). The LCD display is mounted on an adjustable vertical arm, giving the user the comfort of use.

1.7.2 Console

The console incorporates a sleek yet conservative design with easy to reach function controls, It consisting of a keyboard, trackball, an array of push buttons, sliders, rotary encoder, and toggle switches.

1.7.3 Ultrasound Modulo

The ultrasound modulo is the heart of the system. All the system boards and electronics are encased in an aircraft grade aluminum composite case for ease of service.

1.7.4 Transducers

Ultrasonix offers a wide selection of high performance transducers for a variety of imaging applications. Incorporating the latest acoustic materials and technology, Ultrasonix’s lightweight transducers are ergonomic and durable for maximum clinical use.

1.7.5 UPS

SONIX CEP is delivered with a Sola/Hevi-Duty S4K2U700, 120V (volt) UPS from EGS Electrical Group, LLC. The UPS is tucked underneath the SONIX with the necessary controls available from a panel at the bottom front of the system. The UPS battery has a limited power supply When the system is running on battery power it cannot be left unplugged for long periods.

Warnings:

DO NOT attempt to physically access the UPS. This may cause exposure to lethal voltages within the unit even when it is apparently not operating and the input wiring is disconnected from the electrical source.

Observe all cautions and warnings in the manufacturer's UPS manual that is delivered with the product. Failure to do so may result in injury or death.

DO NOT attempt to service this product yourself. Technicians and customers are forbidden from opening the UPS. Attempting to open the UPS may cause exposure to lethal voltages. Should the UPS require maintenance or replacement, only qualified Ultrasonix Service Technicians may perform service as detailed in this Service Manual.

For UPS and battery service issues, please contact Ultrasonix Technical Support.

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CHAPTER 2: SYSTEM SPECIFICATIONS

2.1 DIMENSION

Table 2-1: System Dimensions

Measurement Metric Value US Value

Width 53 cm 21.0 in

Depth 71.0 cm 28.0 in

Height 142.0 cm – 155.0 cm 56.0 in – 61.0 in

Weight 101.8 kg 224.0 lbs

2.2 SYSTEM ARCHITECTURE

• 256 channel fully digital broadband beamformer. • Beam steering for increased sector size on all transducers. • Multi-Vector processing or resolution enhancement. • Powerful single processor microcomputer.

2.3 IMAGING MODES

• B, Dual B, Quad B-Mode • BM Mode • Color, Power and Directional Power Doppler • Split B/Color Mode • Pulsed Wave Doppler (mono and duplex) • Triplex Mode • Clarity (adaptive image adjustment) • Real-time Spatial Compound Imaging • Tissue Harmonic Imaging (THI) • Trapezoidal Imaging (linear transducers) • Tint • Continuous Wave Doppler • 3D Imaging (Freehand) • Panoramic Imaging • Extended Field of View

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2.4 CLINICAL APPLICATIONS

• Abdominal (Aorta) • Biliary • Bladder • Cardiac • Early OB • F(oreign) Bodies • L(ower) Extremity • Late OB • Other • Pelvic • Procedure • Renal • Thoracic • Trauma/FAST • V(ascular) Access

2.5 TRANSDUCERS

• PA4-2/20 broadband (2.8 MHz) N/A phased array • C5-2/60 broadband (3.2 MHz) 60mm curved array • EC9-5/10 broadband (6.6 MHz) 10mm endocavity array • L9-4/38 broadband (4/9 MHz) 38mm transducer • L14-5/38 broadband (8 MHz) 38mm linear array


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2.6 IMAGE PARAMETER ADJUSTMENTS

2.6.1 B Mode

• Gain • TGC • Focus • Dynamic Range • Color Maps • Line Density • Sector Size • Steer • Acoustic Power • Wide Sector • Zoom

2.6.2 M Mode

• Sweep Speed • Sample Volume

2.6.3 Pulsed Wave Doppler

• Doppler Gain • Doppler Frequency • Wall Filter • Sample Volume Angle • Pulse Repetition Frequency • Sweep Speed • Baseline

2.6.4 Color/Power Doppler

• Color Gain • Color Persistence • Color Frequency • Color Threshold • Wall Filter • Steer • Frame Rate Automatic Optimization


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2.7 CLINICAL ANALYSIS

• Measurement Types: • Distance • Continuous Trace • Trace By Points • Ellipse Area • Doppler Acceleration • Doppler Average Velocity • Doppler Trace • M Mode Distance • Time

• E-Med Worksheets • Custom calculation packages • E-Med Measurements/Calculation/Worksheet Package (in mm unless otherwise stated):

Note: The Measurement packages included here are directly connected to the Master Worksheet for the Application in question.

• Abdominal (Aorta) • AP Dia Prox AA • AP Dia Dis AA • Rt Com Iliac (Artery) • Lt Com Iliac (Artery)

• Biliary • GStone Size • GBWT • Bile Duct

• Bladder • Pre-Void Vol • Post-Void Vol

• Cardiac • Est LV EF • Prox AV

• Early OB • FHR • CRL • BPD • GS

• F(oreign) Bodies (Basic Measurements Package) • Distance • Area • Diam Red • Area Red • Hip Angle • 3Dist.Volume


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• L(ower) Extremity (Basic Measurements Package) • Distance • Area • Diam Red • Area Red • Hip Angle • 3Dist.Volume

• Late OB • BPD • HC • AC • FL

• Other (Basic Measurements Package) • Distance • Area • Diam Red • Area Red • Hip Angle • 3Dist.Volume

• Pelvic • Endo Stripe • UT Mass (AP) • UT Mass (TRV) • Rt Ov Max Meas • Rt Ov Cyst (L) • Rt Ov Cyst (W) • Rt Ov Cyst (H) • Lt Ov Max Meas • Lt Ov Cyst (L) • Lt Ov Cyst (W) • Lt Ov Cyst (H)

• Procedure (Basic Measurements Package) • Distance • Area • Diam Red • Area Red • Hip Angle • 3Dist.Volume

• Renal • L Cyst • R Cyst


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• Thoracic (Basic Measurements Package) • Distance • Area • Diam Red • Area Red • Hip Angle • 3Dist.Volume

• Trauma (FAST) • AA AP Dia

• V(ascular) Access (Basic Measurements Package) • Distance • Area • Diam Red • Area Red • Hip Angle • 3Dist.Volume

2.8 IMAGE STORAGE

• DICOM (Digital Imaging and Communications in Medicine) 3.0 • Still Image Storage (PNG, JPEG, BMP, GIF) • Cine Loop Storage (AVI) • Patient/Exam Management • CDR-W (Compact Disc Read-Write) • DVD (Digital Video Device, Medical grade compatible)

• Start Record, Stop Record controlled from console

2.9 SYSTEM BOOT POWER

• Cold Boot: less than 120 seconds


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2.10 EXTERNAL CONNECTIONS

• Parallel Port • Serial Port • USB (Universal Serial Bus) Port (5 Ports) • Video IN/OUT • Audio IN/OUT • PS/2 (2 Connectors) • Ethernet (Hardwired)

• SONIX Live (streaming video) compatible • Modem • BNC (Bayonet Neill Concelman) Connector (2 Connectors) • External AC (Alternating Current) Receptacle (3 Outlets) • Main AC Power Connector • VGA Connector • LCD Display AC Power Cord

2.11 UI LANGUAGES (SELECTABLE)

• English • French (pending)

2.12 ADDITIONAL SOFTWARE FEATURES

• Pictograms • Preset and free-text annotations • Regional font and keyboard layout support (Mandarin, Arabic, etc.) (ISO-IR-100)


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2.13 ADDITIONAL HARDWARE FEATURES

• UPS • during scanning: 25 minutes of power • when idle (imaging is frozen): 30 minutes of power • battery time remaining displayed on LCD display: 100%, 75%, 50%, 25% • Operator alert when remaining battery time falls below 15% of total power.

• retractable power cord (cable reel) • 15 feet (4.57 meters) • guaranteed for 25,000 pull/release cycles.

• Barcode Reader • wireless

• USB 802.11 (b/g) wireless stick • WiFi Protected Access (WPA) and Wired Equivalent Privacy (WEP) compatible • onscreen Signal Strength Indicator • SONIX Live (streaming video) compatible • wireless support for DICOM 3.0 (including Print, Store and Worklist).

• transducer basket • cable hooks.

2.14 ELECTRICAL RATINGS

Table 2-2: Electrical Ratings

Input 120VAC @ 50/60 Hz

Power Rating 120 VAC (Volts Alternating Current) @ 5.4A

Fuse Type 7A/250V SLO-BLO

Fuse Size 6.4mm x 31.8mm

2.15 VOLTAGE

The SONIX CEP is delivered to customers with the voltage already adjusted to the correct setting for the North American market: 110V.

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CHAPTER 3: SYSTEM INSTALLATION

3.1 PRE-INSTALLATION PROCEDURE

3.1.1 Environmental Requirements

Verify the system is to be operated in a room that meets the environmental requirements listed in Table 3-1 (below).

Caution: Avoid placing the system against walls or structures that may decrease air circulation.

Table 3-1: System Environment Specifications

Ambient Operational Temperature 61° to 95° F (16 to 35° C)

Internal Operational Temperature 61° to 131° F (16 to 55° C)

Internal Operational Humidity 10% to 80% (non-condensing)

Storage Conditions +5° to +122° F (-15° to +50° C)

Storage Humidity 10% to 90% (non-condensing)

Warning: Operate in an indoor environment only, free from moisture, flammable liquids, gases, corrosive substances, strong electrical or magnetic fields and equipment that generates high frequency waves.

Ultrasonix cannot guarantee the proper performance of the SONIX CEP if used in the above-listed conditions.

Table 3-2: Barcode Reader

Operating Temperature 32º to 104º F (0º to 40º C)

Storage Temperature -40º to 140º F (-40º to 60º C)

Humidity 5% to 95% relative humidity, non-condensing

Light Levels Up to 4842 Lux (footcandles)

Shock Designed to withstand 1.5 m (5') drops

Contaminants Sealed to resist airborne particulate contaminants

Ventilation None required

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Table 3-3: Wireless Adapters

Operating Temperature 32º to 104º F (0º to 40º C)

Storage Temperature -4º to 158º F (-20º to 70º C)

Humidity 80% maximum, non-condensing

Note: For more details on the wireless adapter and other peripherals, refer to the manufacturer's User's Guides included with the system.

3.1.2 Electrical Requirements

Verify the system is to be operated in a room that meets the electrical requirements listed below.

Table 3-4: Electrical Specifications

Electrical Rating Value

Measurement (System Only) 120 VAC @ 50/60Hz

Current Draw (System Only) 5.4A

Power Draw (System Only @ peak) 700 VA

Leakage Current (System Only) < 150 uA

Note: Refer to OEM peripheral manuals for peripheral-specific electrical ratings.

Warning: If the SONIX CEP utility supply voltage exceeds the acceptable range, the internal circuitry protection feature will not allow the system to power up nor will it allow the battery to charge.

Always ensure the utility supply voltage is within 100 - 127 VAC.

3.1.2.1 Instrument Input Power Rating

An instrument input power rating has been established to clarify the maximum power requirement of the system with all accessories. Depending upon the accessories and options installed, the system may not draw the full amount of power listed below:

Table 3-5: Instrument Power Input Rating

System Voltage, VAC

Nominal System Power Usage, including isolated accessory power

SONIX SystemPower Usage

Isolated Accessory Power Available

120V 5.4A Continuous 4.2A Continuous 1.2A Continuous

For optimal system performance, use a dedicated, interference-free, isolated, grounded wall outlet.


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3.1.3 Electrostatic Discharge

During normal operation, the presence of electrostatic discharge (ESD) can cause system reliability issues. The following are the most common causes for ESD:

• Moving people • Low humidity • Improper grounding • Unshielded cable • Poor connection • Moving machines.

ESD is most likely to occur during periods of low humidity. If the relative humidity is below 50%, static charges can easily accumulate. ESD generally does not occur when the humidity is above 50%. Any time the charge reaches approximately 10,000 volts, it is likely to discharge to grounded metal parts.

Although ESD will not hurt humans, it can damage certain electronic devices. The high-voltage pulse can burn out the inputs of many integrated circuit (IC) devices. This damage might not appear instantly, but it can build up over time, eventually causing the device to fail.

To prevent damage to the system, use ESD minimizing devices where needed. These devices include: anti-static mats, humidifiers, and spray. Proper discharge is required before handling any electronic device such as an ESD strap.


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3.1.4 Electromagnetic and Radio Frequency Interference

This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN 55011 Class 1 and EN 60601-1-2). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses and can radiate radio frequency (RF) energy and if not installed and used in accordance with these instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices (which can be determined by turning the equipment off and on) the user is encouraged to try to correct the interference with one or more of the following measures:

• reorient or relocate the receiving device • increase separation distance between equipment • connect the equipment to an outlet on a circuit different to that which the other device(s) is

connected • consult the manufacturer or field service technician for help.

Warning: The SONIX should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the SONIX should be observed in order to verify normal operation in the configuration in which it will be used.

Table 3-6: EN 60601-1-2:2001 (Table 201)

Guidance and Manufacturer’s Declaration — Electromagnetic Immunity

SONIX Ultrasound Systems are intended for use in the electromagnetic environment specified below. The customer or the user of the SONIX Ultrasound System should ensure that it is used in such an environment.

Emissions Test Compliance Level Electromagnetic Environment-Guidance

RF emissions CISPR 11 Group 1

The SONIX Ultrasound System uses RF energy only for its internal functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class A

Harmonic emissions

IEC 61000-3-2 Class A

Voltage fluctuations/

flicker emissions IEC 61000-3-3

Complies

The SONIX Ultrasound System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.


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Table 3-7: EN 60601-1-2:2001 (Table 202)

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

SONIX Ultrasound Systems are intended for use in the electromagnetic environment specified below. The customer or the user of the SONIX Ultrasound System should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment-Guidance

Electrostatic discharge (ESD) IEC 601000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

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

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines

±1kV for input/output lines

±2 kV for power supply lines

±1kV for input/output lines

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

Surge IEC 61000-4-5

±1kV differential mode

±2kV common mode

±1kV differential mode

±2kV common mode

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

Voltage DIPS, short

interruptions and voltage variations on power supply

input lines IEC 61000-4-11

95% dip in UT)

for 0,5 cycle

40% UT (60% dip in UT)

for 5 cycles


for 25 cycle

95% dip in UT)

for 5 sec

95% dip in UT)

for 0,5 cycle


for 5 cycles


for 25 cycle

95% dip in UT)

for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SONIX Ultrasound System requires continued operation during power mains interruptions, it is recommended that the SONIX be powered from an uninterruptible power supply (UPS) or a battery.

Power frequency (50/60 Hz)

magnetic field IEC 61000-4-8

3A/m 3A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial environment.

Note: UT is the AC mains voltage prior to application of the test level.


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Table 3-8: EN 60601-1-2:2001 (Table 204)

Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

The SONIX is intended for use in the electromagnetic environment specified below. The customer or the user of the SONIX should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment-Guidance

Conducted RFIEC 61000-4-6

Conducted RFIEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m

80 MHz to 2,5 GHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the SONIX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distances:

Pd 2,1= 150kHz to 80 MHz

Pd 2,1= 80 MHz to 800 MHz

Pd 3,2= 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 surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency 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 SONIX is used exceeds the applicable RF compliance level above, the SONIX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SONIX.

b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.


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Table 3-9: EN 60601-1-2:2001 (Table 206)

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the SONIX

The SONIX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SONIX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SONIX, as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter m Rated maximum

output power of transmitter W

150 kHz to 80 MHz

Pd 2,1= 80 MHz to 800 MHz

Pd 2,1= 800 MHz to 2.5 GHz

Pd 3,2= 0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating 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.


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3.1.5 Wiring Requirements

3.1.5.1 Main AC Connection

The electrical feed to the system should be a dedicated/isolated line (no other equipment on the same line) with a third-wire ground. Ensure a low impedance path for current to return to the source.

3.1.5.2 Ethernet (Hard-Wired) Network Connection

It is the user’s responsibility to provide an Ethernet connection to the system and to install the correct type of cable in accordance with the building's applicable standards. The commonly used cable is CAT5 (Category 5, 10 Base-T, unshielded twisted pair).

Caution: The SONIX CEP networking options are intended for use inside your organization's firewall. Organizations that elect to configure/use the networking functionality provided by Ultrasonix are assuming all liabilities and risks associated with that decision.

3.1.5.3 Image Management Network

Obtain the following information from the system administrator:

• list of all equipment that is part of the Image Management network • logical diagram of the network showing topology, subnets, etc. • location of all equipment • location of all LAN (Local Area Network) attachment points • wireless network name(s), wireless security protocols, wireless keys, etc • locations of all power outlets and connector types • location of any dedicated analog phone line • all necessary Internet Protocol (IP) addresses and subnet information.


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3.2 SYSTEM INSTALLATION

3.2.1 Preliminary Inspection

To Inspect the Shipping Crate and Box Upon Arrival:

1. Examine the shipping container for any damage that may have occurred during transport.

2. Look for evidence to ensure that the crate has not been opened.

3. Examine the "Tip and Tell" attachment on the outside of the package to ensure the crate has not been tipped too far during transport and delivery.

"Tip and Tell" = Acceptable

"Tip and Tell" = Unacceptable

4. Report any damage to both the carrier and Ultrasonix.


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3.2.2 Uncrating Instructions

Equipment/Tools/Personnel Required:

• Box Cutter or Scissors • Two (2) people.

Note: Before uncrating the system, ensure there is adequate room for removing it from its packaging. The space should be at least equivalent to the crate's overall dimensions.

To Uncrate the SONIX CEP System:

1. Cut and remove the four (4) ¼” nylon straps around the box.

Caution: Stand out of the way when cutting these straps as they are under tension and may snap back when severed.

2. Lifting from the bottom, remove the cardboard cover.

3. Remove the paperwork from the console packaging.

4. Remove the foam and cardboard packaging from around the console, gently pulling on the foam from first one side, then the other.

5. Remove the LCD display and transducer boxes from below the front of the console and any peripherals from below the rear of the console.

6. Remove the lower front foam packaging and the bottom rear foam packaging.


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7. Remove the white foam "ramps" from either side of the system.

8. Unfold the cardboard box and remove the supporting foam underneath each side of the system.

9. Using the pre-cut slit in the white foam ramps, insert them onto the folded cardboard and align them with the wheels.

10. Unlock the system wheels, lift/roll it clear of the packing foam, then roll it down off the palette.

Note: Because the wheels sit in depressions, the system will have to be semi-lifted out of these (both front and back) in order to roll it down the ramp. If space permits, roll the system off the palette from the rear. One person should grasp the rear handles while the second person should grab hold of the front of the Peripheral Shelf edge – making sure to wrap their fingers around the underlying metal structure. Using a mixture of lifting (to clear the foam indentations in which the wheels are located) and pulling/pushing, the system can be offloaded until it is clear of the packing and can be slowly rolled down the ramp.


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3.2.3 Mounting the Arm for the LCD Display

Equipment/Tools Required:

• 4mm Allen key (provided, in LCD display box).

Note: Be sure to uncrate the system first (see 3.2.2 Uncrating Instructions for details).

To Mount the Arm for the LCD Display:

1. Open and unpack the box containing the LCD display.

2. Find the Allen key provided in this box.

Note: This box also contains the thumbscrews required to mount the LCD display.

3. Remove the foam packaging from around the tower.

4. Remove the bubble wrap from around the cable ends.

5. Carefully cut the zip tie from around the system handle and arm mount.

Note: Hold the arm mount firmly so that it doesn't move suddenly when the tie is cut.


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6. Install the LCD display arm onto the tower.

7. Hand-tighten the screw for the LCD display arm using the 4mm Allen Key provided with the system.


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3.2.4 Mounting the LCD Display

Figure 1–1: LCD Display Assembly

To Mount the LCD Display:

1. Adjust the base of the LCD display until its support faces back and the front faces forward.

2. Rest the LCD Display on its support.

3. Fasten the LCD display to the support arm with the four (4) thumbscrews (provided in the box with the LCD display).

4. Plug three (3) of the external cables into the back of the LCD display: LCD display power, DVI and USB cables.

Note: There will be one cable remaining, a USB connector for the wireless adapter. Refer to section 3.2.15 Wireless Connection for details on installing this option.


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3.2.5 System Case Connectivity Panel Check

The System Case Connectivity Panel is accessible from the top of the system case. Check to ensure that all cables are securely plugged into their respective slots. In addition, remove the rear cover as per section 8.4.3 and ensure the additional power cables are securely connected.

Figure 3-1: System Case Connectivity Panel (SX3.0 – CEP)

Table 3-10: System Case Connectivity Panel

1 PS2 Mouse port Used by the operator console trackball.

2 PS2 Keyboard port Used by the operator console keyboard.

3 RS232 Serial port Used by the operator console.

4 Parallel port A factory installed dongle connected to this port is required to activatesome of the system features. Additionally, this port can be used toconnect an Ultrasonix-approved parallel-port printer.

5 Video output port Port is disabled.

6 USB ports (2)

Used by the two (2) USB ports at the front of the operator console and theUSB port on the rear of the CEP operator console (barcode readerconnection).

Note: When using CEP software on a SONIX OP or SP, use the second of these USB ports to connect the barcode reader. Take care to ensure that the cord does not tangle.

7 USB ports (2) Used by the LCD display and wireless adapter.

8 Sound connections Line-in – may be used to connect an Ultrasonix-approved audio input device.System Speaker connection. System Microphone connection. Disabled.

1 4

2 3 5 6 7 8

9 10

11 12 13

14

15 17

18

19

20

16


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9

Video VGA output OR Digital Video DVI video output

May be used to connect either an Ultrasonix -approved: • RGB-Sync (Red Green Blue) output video

device such as a VCR (video cassette recorder) or DVD recorder. For this, a custom cable will be provided as shown

• computer video output device such as a LCD projector or a VGA monitor.

Refer to item 14, below.

10 RS232 Serial Port May be used to connect an Ultrasonix-approved RS232 serial device.

Note: In the event that the UPS must be programmed in the field, use of this RS232 Serial Port will be required.

11 Speaker power connector In use by the system speakers.

12 System Power Switch In use by the operator console – ON/OFF switch.

13 Video outputs

Connected to a video splitter module that outputs Black & White (B&W) and Color video.

Note: The B&W and Color video outputs are typically routed to the back connectivity panel. These may also be connected directly to a video output device. Refer to 3.2.6 Back Connectivity Panel for details.

14

Digital Video DVI video output OR Video VGA output

In use by the system's LCD display. A DVI splitter may be used to connect additional Ultrasonix-approved DVI Video output devices. Refer to item 9, above.

15 RS232 Serial port In use by the operator console.

16 USB ports (2) Used by the UPS and internal modem (where applicable).

17 Console power connector In use by the operator console.

18 Freeze BNC

May be used to trigger a Freeze or Print function by connecting directly to an Ultrasonix-approved switching device, such as a foot pedal. Refer to Chapter 6: Connect Peripherals to configure the trigger action of the Foot Pedal device.

19 Print BNC Port may be connected directly to an Ultrasonix-approved triggered device, such as a video printer. Refer to Chapter 6: Connect Peripherals to configure the print keys.

20 Ethernet The Ethernet connection is typically routed to the Back Connectivity Panel. It may also be connected directly to the Ethernet from this location. This port supports 10/100Mb.


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3.2.6 Back Connectivity Panel

The Back Connectivity Panel can be accessed from the back of the system. The connectors are routed internally to the system case connectivity panel which enables easy configuration. In its standard configuration, the panel provides:

Table 3-11: Back Connectivity Panel

B&W OUT or B&W VIDEO

Use this port to connect an Ultrasonix approved video outputdevice such as a B&W video printer or a frame grabber.

COL OUT or COL VIDEO

Use this port to connect an Ultrasonix approved video outputdevice such as a Color video printer, VCR or a frame grabber.

NET (Network) or LAN (Local Area Network)

Use this port to connect the system to a network. This portsupports 10Mb/100Mb.

PHONE Use this port to connect the modem to a phone line. This will allow the system to be configured for remote and online support (refer to 4.4 Network for details on configuring a dialup connection).

Figure 3-2: Back Connectivity Panel

Note: The "CE" mark may not be present on the CEP hardware.

3.2.7 Front Console Connectivity

Figure 3-3: Front Console (Connectivity)

The SONIX system provides 2 USB ports and a CD/DVD writer at the front of the operator console.

These 2 USB Ports can be used to connect Ultrasonix-approved USB devices such as USB thumb drives to the system for image file transfer.

Note: Below and to the left side of the CD/DVD slot is a black button. Press this to eject the CD/DVD from the drive.


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3.2.8 Rear Console Connectivity (CEP Barcode Reader)

The rear console USB connection is to be used only for the barcode reader.

Figure 3-4: Rear Console USB Port Connection for the Barcode Reader (CEP)

3.2.9 Fuses

The diagram below shows the location of the EMI Filter which houses the SONIX CEP fuses. Refer to 3.2.10 Changing Fuses for details on how to remove the fuse box and replace the fuse(s).

Figure 3-5: Voltage Adjustment Devices

With Rear Shroud Rear Shroud Removed

USB port connector for barcode reader


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3.2.10 Changing Fuses

The rear shroud must be removed in order to change the fuse(s). Refer to 8.4.3 Accessing the System Case.


• #1 flat head screwdriver

To Change the Fuse:

1. Make sure the UPS is powered down and the system completely turned off.

2. Unplug the SONIX CEP from the wall socket and remove the rear shroud (refer to 8.4.3 Accessing the System Case for details).

3. Use the screwdriver to open the fuse box lid.

4. Use the screwdriver to take out the fuse box. Position the screwdriver at the top, as in previous step.

5. Replace the blown fuse(s) as required

Note: It should not be necessary to use a screwdriver to remove the fuses.

Caution: Make sure the fuse type is: 3AG Slo-Blo, 7A/250V


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3.2.11 UPS

Because the UPS battery may be delivered completely drained of power (and turned off), it will need to be turned on and fully charged before the installation process can be completed.

Note: To ensure the battery is completely charged at the time of installation, the system may need to be plugged in (and left uninterrupted) for at least six (6) hours.

Figure 3-6: SOLA Panel

Warnings:

DO NOT attempt to physically access the UPS. This may cause exposure to lethal voltages within the unit even when it is apparently not operating and the input wiring is disconnected from the electrical source.

Observe all cautions and warnings in the manufacturer's UPS manual that is delivered with the product. Failure to do so may result in injury or death.

DO NOT attempt to service this product yourself. Technicians and customers are forbidden from opening the UPS. Attempting to open the UPS may cause exposure to lethal voltages. Should the UPS require maintenance or replacement, only qualified Ultrasonix Service Technicians may perform service as detailed in this Service Manual.

For UPS and battery service issues, please contact Ultrasonix Technical Support.

STANDBY Button

ON Button


33

3.2.11.1 Powering the UPS ON and OFF

To Power ON the UPS:

1. Plug the SONIX power cord into a wall outlet.

2. On the SOLA panel at the bottom front of the system, press and hold the ON button for one (1) second until the UPS beeps.

Note: The UPS ON light on the SOLA panel should now be lit.

To Power OFF the UPS:

Note: When the UPS is off, the SONIX CEP will not run even if it is plugged into an AC power source.

1. On the SOLA panel at the bottom front of the system, press and hold the STANDBY button for one (1) second.

2. Once the UPS enters standby mode (i.e., the BYPASS light is on), press and hold the STANDBY button for two (2) seconds until the UPS beeps.

3. Within four (4) seconds of the beep emitted during Step 2, press the STANDBY button again and the UPS will power down.

Notes:

The UPS ON light on the SOLA panel should now be out.

If the UPS is off, but still connected to an AC power source, the AC INPUT light will be on, indicating that the UPS battery is charging.


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3.2.12 Connecting the Barcode Reader

Although the barcode reader was designed to function primarily with the CEP, it can also be used on the SONIX OP/SP platforms.

Caution: Do not apply ultrasound gel to the barcode reader.

Warnings:

USE OF CONTROLS or adjustments or performance of procedures other than those specified in the manufacturer's User's Guide (delivered with barcode reader) may result in hazardous laser light exposure.

NEVER attempt to look at the laser beam, even if the scanner appears to be non-functional.

NEVER point the laser beam in anyone's eyes.

USE OF OPTICAL instruments with the laser equipment will increase eye hazard.

UNDER NO CIRCUMSTANCES should users attempt to service the laser scanner.

Technicians and customers are forbidden from opening the barcode reader. Attempting to open the barcode reader may cause exposure to hazardous laser light. Should the barcode reader require maintenance or replacement, only qualified Ultrasonix Service Technicians may perform service as detailed in this Service Manual.

3.2.13 CEP

To connect the barcode reader, plug the reader's USB connector into the USB port on the back of the operator console.

Note: To keep the barcode reader handy, store it in one of the smaller transducer holders.

Figure 3-7: Rear Console USB Port Connection for the Barcode Reader (CEP)

USB port connector for barcode reader


35

3.2.13.1 SONIX OP/SP

Plug the barcode reader's USB connector into one of the USB ports at connection 7 on the SX1.0 or SX1.1 System Case Connectivity Panel (for details, refer to Figures 9-1 and 9-2, respectively, in the SONIX CEP User Manual).

Note: To keep the barcode reader handy, store it in one of the smaller transducer holders.

3.2.14 Unwinding/Retracting the Power Cord (CEP)

Before plugging in the retractable power cord, move the SONIX into the desired position. Gently pull the cord from its housing until it is long enough to comfortably reach the power connection. There should be a small amount of slack so that the cord is not under tension, but not so much that it pools on the floor, causing a possible tripping hazard or interfering with the smooth operation of the SONIX wheels.

To retract the cord back into its housing, grasp the cable plug firmly in one hand, remove it from the plug hook, then pull gently on the cable end nearest the base of the system until one (1) click is heard/felt. At this point, release the cable – but not the plug – and it will automatically retract until it encounters the resistance caused by retaining hold of the plug. Insert the plug into the hook provided at the base of the system. This will ensure that it is always readily available for use.

Note: If the plug is not latched into the hook provided, it will have to be retrieved from beneath the system.

Figure 3-8: Retractable Power Cord and Plug Hook

Plug Hook


36

Warnings:

DO NOT extend the cable into traffic areas as this can cause a tripping hazard.

DO NOT let go of the plug end of the cable while it is rewinding. Guide it gently back into its housing. If left to rewind on its own, the cable's whipping effect may cause injury.

DO NOT unwind/rewind the cable while the plug is latched to the plug hook. This will abrade the cable and may result in electrical shock to the Operator.

Technicians and customers are forbidden from opening the cable reel which houses the retractable power cord. Attempting to open the cable reel may cause physical injury and/or exposure to lethal voltages. Should the cable reel require maintenance or replacement, only qualified Ultrasonix Service Technicians may perform service as detailed in this Service Manual.

Caution: Always unwind/rewind the cable by pulling/releasing from behind the system, not

from the side.

Note: The retractable power cord is guaranteed for 25,000 pulls.


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3.2.15 Wireless Connection

Mount and configure the SONIX CEP wireless adapter during system installation. Each adapter is delivered with a bracket and two (2) set screws which are used to gently tighten the adapter in the bracket so it cannot move once it is secured.

Note: Use the set screw to secure the wireless adapter in the bracket after attaching it to LCD display.

Figure 3-9: Wireless Bracket with Set Screws


• #2 Allen Key (provided in the bag with thumbscrews).

To Attach the Wireless Adapter to the CEP:

1. Gently secure the wireless adapter to the bracket, tightening with the set screws with a #2 Allen key.

2. Remove the bottom left thumbscrew on the back of the LCD display.

3. Place the screw hole of the prepared wireless bracket over the thumbscrew mounting

position and reattach the thumbscrew through the bracket.

4. Attach the USB connector to the wireless adapter.

Note: Before making the USB connection, be sure to remove the cover protecting the wireless adapter's USB connector.


38

To Attach the Wireless Adapter to the SONIX OP/SP:

1. Ensure the wireless adapter has been gently secured in the wireless bracket.

Note: Tighten the set screws with the #2 Allen Key (provided in bag with thumbscrews).

2. Remove the bottom left thumbscrew on the back of the LCD display.

3. Place the screw hole of the prepared wireless bracket over the thumbscrew mounting

position and reattach the thumbscrew through the bracket.

4. Attach one end of the USB connector to the wireless adapter and the other to one of the

spare USB ports on the System Case Connectivity Panel.

Note: Before making the USB connection, be sure that the cover protecting the wireless adapter's USB connector has been removed.


39

3.2.16 Final Inspection

Note: If possible, the UPS should be fully charged before completing the Final Inspection.

1. Inspect the system for scratches or damage. Note any damage to the system and report it to Ultrasonix.

2. Plug main AC to primary power connector.

3. Turn on the system.

Note: The console POWER button is located to the left of the touch screen.

4. Confirm the UPS is powered on.

5. Inform the facilities representative when the system is installed and ready for any safety testing they would normally conduct.

6. Once it is running, the LCD display will show a black background image field with settings information or the patient ID menu.


40

CEP Service Manual 00.053.008, Revision B Chapter 4: Performance Test

41

CHAPTER 4: PERFORMANCE TESTING

4.1 INTRODUCTION

This section describes the various tests performed on the system immediately following installation, updating and repair. The purpose of performance testing is to verify the correct operation of system (hardware, software and mechanical). During these tests, the system should be running in normal operating mode.

4.2 CONSOLE TEST

The table below (Table 4-1) describes the applicable commands for each imaging mode operation.

Table 4-1: Mode Command Table

Mode Default

Applicable Command

Default Programmables

B Mode Dual B Mode Quad B Mode Compound B Mode

• Gain • Depth • Focus • Angle • Color Map • Power • Persistence

1. Optimization Mode 2. Sector Size/Zoom 3. Optimization Mode DR 4. Wide Mode

Color Mode

• Depth • Focus • Angle • Baseline • Invert • PRF • Color Map • Color Gain • Power • Frequency • Acoustic Display • Color Frequency


Chapter 4: Performance Test 00.053.008, Revision B CEP Service Manual

42

Doppler Modes

• Doppler Gain • PRF • Doppler Frequency • WF • Sweep Angle • Sweep • Gate • Live Mode


All Modes

• TGC • Annotation • Probe Selection • Patient/Exam Management • Cine Loop • Freeze • Cine Loop Record • Measurement • Mouse Wheel • Print • Optimization Mode DR • Optimization Mode • LD • Persistence • Gain


The current mode is identified with an ORANGE LED (Light Emitting Diode). Applicable console operations are identified with a BLUE LED or a PURPLE LED for QUAD. Adjust the image with the console controls and verify the operation corresponds with the controls. Note any operations that do not function properly.

4.3 IMAGE TEST

To Conduct an Image Test:

1. Connect each of the different transducers available and run B mode.

2. Verify that the image scanned has all elements present. Note any black static line(s) that are visible on the image.

3. If found, test with the other transducers to verify the non-visible element(s) is in the same location.

4. Try different transducer connectors to eliminate the possibility of a malfunctioning transducer.

CEP Service Manual 00.053.008, Revision B Chapter 4: Performance Test

43

4.4 COMMUNICATION TEST (HARD-WIRED)

Figure 4-1: Network Configuration Page

4.4.1 LAN Communication Test (Hard-Wired)

Note: Do not select the Chat Support Enabled checkbox unless there is an Internet connection available.

To Configure a LAN Connection (If Available)

1. Connect an RJ45 cable to the "LAN" port located on the Back Panel.

2. Press the console MENU button.

3. Select Administrator > Network >.

4. Under Network Setup, se

sonix cep ultrasound system service manual...cep service manual 00.053.008, revision b ultrasonix...

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