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Functional Checks

4-12

Invenia ABUS 2.0 – System Setup and Basic Service Manual

4700-0043-00 Rev. 4

Functional checks

Overview

This section describes the functional checks used with the
Invenia ABUS 2.0. Functional checks are used to verify that the
product works as specified after performing maintenance
procedures. Functional checks may also be used during
troubleshooting.

Performance Functional Checks

Power On/Boot Up Functional Check

Confirm that the system:

•

Powers on when you press the On/Off/Standby control.

•

That the transducer moves across the Scan Head
Assembly.

•

That the software runs through its initialization.

•

And that each user type (User or Admin) can successfully
login to the system.

Power Shut Down Functional Check

Confirm that the system exits the application and powers down.

Transducer Functional Check

Ensure that the transducer:

•

Upon Power Up moves across the Scan Head Assembly.

•

That the lights on the Scan Head Assembly light up.

•

That the Transducer images as a scan is being performed.

•

That the Transducer generates a 3D Volume.

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Summary of Contents for H5018SC

Page 1: ...Technical Publication 4700 0043 00 Rev 4 InveniaTM ABUS 2 0 System Setup and Basic Service Manual Operating Documentation Copyright 2018 2019 by General Electric Company Inc All Rights Reserved ...

Page 2: ...Product Information CE0197 This manual is a reference for the Invenia ABUS 2 0 It applies to Version 2 0 software or later ...

Page 3: ...entative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698 Revision Date YYYY MM DD Reason for change Rev 1 2018 07 19 Initial release Rev 2 2019 01 04 Update package information and unpacking procedure Rev 3 2019 01 18 Update revision number Rev 4 2019 04 07 Update device label information Pages Revision Pages Revision Front Rev 4 Chapter 6 Rev 4 Fron...

Page 4: ...i 2 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 Important precautions Translation policy ...

Page 5: ...Invenia ABUS 2 0 System Setup and Basic Service Manual i 3 4700 0043 00 Rev 4 ...

Page 6: ...i 4 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 7: ...Invenia ABUS 2 0 System Setup and Basic Service Manual i 5 4700 0043 00 Rev 4 ...

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Page 9: ...Invenia ABUS 2 0 System Setup and Basic Service Manual i 7 4700 0043 00 Rev 4 ...

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Page 11: ...Invenia ABUS 2 0 System Setup and Basic Service Manual i 9 4700 0043 00 Rev 4 ...

Page 12: ...i 10 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 13: ...Invenia ABUS 2 0 System Setup and Basic Service Manual i 11 4700 0043 00 Rev 4 ...

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Page 16: ...i 14 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 17: ...sted within this 14 day period Certified electrical contractor statement For USA Only All electrical Installations that are preliminary to positioning of the equipment at the site prepared for the equipment shall be performed by licensed electrical contractors Other connections between pieces of electrical equipment calibrations and testing shall be performed by qualified personnel In performing a...

Page 18: ...th specific information listing the system type manual title part number revision number page number and suggestion details Mail the information to GE Medical Systems Ultrasound and Primary Care Diagnostics LLC 9900 Innovation Drive Wauwatosa WI 53226 GE employees should use Post market Quality Management PQM to report service documentation issues These issues will then be in the internal problem ...

Page 19: ...l safety requirements refer to Chapter 1 in the Service Manual DANGER DANGEROUS VOLTAGES CAPABLE OF CAUSING DEATH ARE PRESENT IN THIS EQUIPMENT USE EXTREME CAUTION WHEN HANDLING TESTING AND ADJUSTING WARNING Use all Personal Protection Equipment PPE such as gloves safety shoes safety glasses and kneeling pad to reduce the risk of injury ...

Page 20: ...ied or duplicated in any form in whole or in part without prior written permission GE may revise this publication from time to time without written notice Trademarks All products and their name brands are trademarks of their respective holders Copyrights All Material Copyright 2018 2019 by General Electric Company Inc All Rights Reserved ...

Page 21: ...dels covered by this manual 1 3 Instrument Overview Invenia ABUS 2 0 1 4 View on PACs 1 7 Important conventions Conventions used in book 1 8 Standard hazard icons 1 10 Standard Icons that indicate that a special procedure is to be used 1 11 Product icons 1 11 Label locations 1 12 Safety considerations Introduction 1 13 Dangerous procedure warnings 1 16 Electrical safety 1 17 Mechanical safety 1 18...

Page 22: ...eiving and unpacking 3 4 Receiving the Invenia ABUS 2 0 3 5 Unpacking the Invenia ABUS 2 0 3 9 Preparing for Setup Verify customer order 3 34 Physical inspection 3 34 EMI protection 3 34 Warning Label Locations 3 35 Setup Warnings and Cautions 3 40 Electrical specifications 3 41 Connections on the Rear Panel 3 42 Switch ON the AC Power to Invenia ABUS 2 0 3 45 Power shut down 3 45 Setting up the I...

Page 23: ...ectivity Functional Checks 4 15 Chapter 5 Components and Functions Theory Introduction Overview 5 2 General physical design of the ABUS 2 0 system 5 5 Physical mechanical main elements 5 5 General theory of operation Introduction 5 7 Image handling 5 7 Image file management 5 8 System elements and their operation 5 9 PC box 5 11 Weight Tower 5 14 Scan Arm Assembly 5 17 Scan Head 5 19 Display arm a...

Page 24: ... Procedures Warnings and important information Warnings 8 2 Manpower 8 3 Returning shipping transducers and repair parts 8 4 Parts Disposal Used Media and Used Parts Disposal 8 5 Cleaning the Filter Replacement Filter Replacement Functional Check 8 7 Replacing the Transducer Replacing the Transducer continued 8 10 Transducer Functional Check 8 11 B Mode Functional Checks 8 11 3D Volume Functional ...

Page 25: ...Invenia ABUS 2 0 System Setup and Basic Service Manual i 23 4700 0043 00 Rev 4 Care and Maintenance Schedule Cleaning Cleaning Scan Head Assembly 10 6 Cleaning Air Filter 10 8 Index ...

Page 26: ...i 24 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 27: ...00 0043 00 Rev 4 Chapter 1 Introduction This chapter describes important issues related to safely servicing the Invenia ABUSTM 2 0 The service provider must read and understand all the information presented here before installing or servicing the Invenia ABUS 2 0 ...

Page 28: ...eparations Contains pre setup requirements for the Invenia ABUS 2 0 3 System Setup Contains setup procedure with procedure checklist 4 General Procedures and Functional Checks Contains functional checks that must be performed as part of the installation or as required during servicing and periodic maintenance 5 Components and Functions Theory Contains functional explanations of the electronics 6 S...

Page 29: ...on To verify the software version on the instrument please refer to Chapter 4 in this manual Purpose of the operator manual The operator manual should be fully read and understood before operating the Invenia ABUS 2 0 eIFU Invenia ABUS 2 0 documentation is provided to the customer in the electronic Instruction for Use Kit eIFU Kit that is shipped with the Invenia ABUS 2 0 The eIFU Kit provides all...

Page 30: ...ata sets for viewing in three orthogonal planes and standard Ultrasound images permitting Interpreting Physicians to quickly review locate and mark regions of interest Figure 1 1 Invenia ABUS 2 0 The terms scan station product device or instrument may be used interchangeably throughout the manual to indicate the Invenia ABUS 2 0 product ABUS Automated Breast Ultrasound System ...

Page 31: ...ally to the Display 3 System configuration is stored on the itself All necessary software is loaded from the hard drive upon powerup 1 Scan Head with C15 6XW Reverse CurveTM Ultra broadband transducer 2 Scan Arm 3 Display Arm with Touch Screen Monitor 4 Weight Tower 5 Table with Ultrasound Coupling Lotion Holders 6 System Standby Button On Off 7 Chassis containing Power Cord Mains Power Switch Net...

Page 32: ...The Invenia ABUSTM 2 0 can be place at various positions around the exam table The following figure shows the recommended clearance around the table Figure 1 3 Minimum space around the exam bed Maximum arm reach is 40 inches 1 02 m 0 76 m or 30 clear space recommended 0 61 m or 24 clear space recommended ...

Page 33: ...exam can be transferred manually or automatically to a DICOM compatible viewing station for review After the review the exam can be sent to a PACS for archiving or to some other form of manual archive Figure 1 4 PACS network Customers that want more integrated workflows or enterprises with multiple locations can benefit from the storage and View on PACS capability ...

Page 34: ...ant conventions Conventions used in book Important conventions used in this document are described next Icons Pictures or icons are used wherever they will reinforce the printed message The icons labels and conventions used on the product and in the service information are described in this chapter ...

Page 35: ...es are used to provide important information about an item or a procedure NOTE Be sure to read the notes the information contained in a note can often save you time or effort DANGER DANGER IS USED TO INDICATE THE PRESENCE OF A HAZARD THAT WILL CAUSE SEVERE PERSONAL INJURY OR DEATH IF THE INSTRUCTIONS ARE IGNORED WARNING WARNING IS USED TO INDICATE THE PRESENCE OF A HAZARD THAT CAN CAUSE SEVERE PER...

Page 36: ...hin a triangle or the symbols for Danger Warning or Caution as seen throughout this chapter In addition to text several different graphical icons symbols may be used to make you aware of specific types of hazards that could possibly cause harm Even if a symbol isn t used in this manual it may be included for your reference Table 1 3 Standard hazard icons ELECTRICAL MECHANICAL HEAT PINCH MAGNET PAC...

Page 37: ...s that should be followed Be sure to read the notes the information contained in a note can often save you time or effort Product icons Always refer to the product s User Manual for a full list of labels used on the Invenia ABUS 2 0 Table 1 4 Standard Icons that indicates that a special procedure is to be used Avoid Static Electricity Tag and Lockout Wear Eye Protection Hand Protection Foot Protec...

Page 38: ... 0043 00 Rev 4 Label locations It is important to refer to the current revision of the Invenia ABUS 2 0 Basic User Manual for a full list of product labels prior to servicing the system The following figure shows the location of the GE Cares Label on the Invenia ABUS 2 0 monitor ...

Page 39: ...ted in an Invenia ABUS 2 0 Training Seminar are authorized to service the internal components of this equipment DANGER DANGEROUS VOLTAGES CAPABLE OF CAUSING DEATH ARE PRESENT IN THIS EQUIPMENT USE EXTREME CAUTION WHEN HANDLING TESTING AND ADJUSTING DANGER WHERE APPLICABLE THERE ARE SEVERAL PLACES ON THE IMAGING ENGINE CHASSIS THE AC DISTRIBUTION DC DISTRIBUTION AND TIP BOARD THAT ARE DANGEROUS BE ...

Page 40: ...T operate the equipment in an explosive atmosphere Operation of any electrical equipment in such an environment constitutes a definite safety hazard WARNING DO NOT substitute parts or modify equipment Because of the danger of introducing additional hazards ONLY install GE approved parts DO NOT perform any unauthorized modification of the equipment WARNING Ensure that the Invenia ABUS 2 0 is turned...

Page 41: ...nal Protection Equipment PPE such as gloves safety shoes safety glasses and kneeling pad to reduce the risk of injury WARNING Beware of possible sharp edges on all mechanical parts If sharp edges are encountered the appropriate PPE should be used to reduce the risk of injury WARNING Wear all PPE including gloves as indicated in the chemical MSDS ...

Page 42: ...ING AND ADJUSTING Heat warning If the covers are removed from an operating Invenia ABUS 2 0 some metal surfaces may be warm enough to pose a potential heat hazard if touched even while in shutdown mode Explosion Hazard Explosion Warning DO NOT operate the equipment in an explosive atmosphere Operation of any electrical equipment in such an environment constitutes a definite safety hazard WARNING E...

Page 43: ...utlet used for this equipment should not be shared with other types of equipment Both the system power cable and the power connector must meet international electrical standards Transducer Follow these guidelines before connecting the transducer to the Invenia ABUS 2 0 Inspect the transducer prior to each use for damage or degradation to the housing lens seal connector pins Do not use a damaged or...

Page 44: ...afety shoes when doing work where there is any chance of foot injury WARNING Personal Injury Use protective gloves when working with sharp edges or when directed to wear PPE during a removal replacement procedure WARNING Personal Injury Do not pull out or insert circuit boards while power is on WARNING Personal Injury To avoid injury when you move the Touch Screen Display and the Display Arm do no...

Page 45: ...d along any incline use extreme caution since it may become unstable and tip over CAUTION Loss of Data While the software install procedure is designed to preserve data ensure that all patient exams have transferred to an image viewer or storage such as PACS CAUTION Equipment Damage Ultrasound transducers are highly sensitive medical instruments that can easily be damaged by improper handling Use ...

Page 46: ... Keep the heat venting holes on the Touch Screen Display unobstructed to avoid overheating of the Display CAUTION Equipment Damage Practice good electrostatic discharge ESD prevention Wear an anti static strap when handling electronic parts and even when disconnecting connecting cables CAUTION Equipment Damage Do not operate this Invenia ABUS 2 0 unless all board covers and frame panels are secure...

Page 47: ... system is firmly secured while inside the vehicle Secure system with straps or as directed otherwise to prevent motion during transport Prevent vibration damage by driving cautiously Avoid unpaved roads excessive speeds and erratic stops or starts System must remain upright at all times Severe damage may occur if transported other than upright CAUTION Equipment Damage Do not transport Invenia ABU...

Page 48: ...magnetic interference RFI EMI and can be radiated through space or conducted over interconnecting power of signal cables In addition to electromagnetic energy EMC also includes possible effects from electrical fields magnetic fields electrostatic discharge and disturbances in the electrical power supply Compliance Invenia ABUS 2 0 conforms to all applicable conducted and radiated emission limits a...

Page 49: ...vised ESD connection point located on the rear of the Invenia ABUS 2 0 near the power connector Follow general guidelines for handling of electrostatic sensitive equipment WARNING Risk of electrical shock Invenia ABUS 2 0 must be turned off Avoid all contact with electrical contacts conductors and components Always use non conductive handles designed for the removal and replacement of ESD sensitiv...

Page 50: ...ual or if you require additional assistance please contact the GE Service or appropriate support resource Note the following 1 System ID serial number 2 Software version 3 Date and time of occurrence 4 Sequence of events leading to issue 5 Is the issue repeatable Refer to Figure 3 2 on page 3 35 to locate the System ID Serial Number on the Invenia ABUS 2 0 Specific label descriptions can be found ...

Page 51: ...Customer assistance Invenia ABUS 2 0 System Setup and Basic Service Manual 1 25 4700 0043 00 Rev 4 Phone numbers for Customer Assistance ...

Page 52: ...US 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 System manufacturer Table 1 5 System manufacturer MANUFACTURER GE Medical Systems Ultrasound and Primary Care Diagnostics LLC 9900 Innovation Drive Wauwatosa WI 53226 ...

Page 53: ...try as well as the people who will receive or open this package NOTE The US Department of Transportation DOT has ruled that items that were saturated and or dripping with human blood that are now caked with dried blood or which were used or intended for use in patient care are regulated medical waste for transportation purposes and must be transported as a hazardous material NOTE The USER SERVICE ...

Page 54: ... for service purposes GE will ascertain agreement from the customer Patient information shall only be transferred by approved service processes tools and devices restricting access protecting or encrypting data where required and providing traceability in the form of paper or electronic documents at each stage of the procedure while maintaining compliance with cross border restrictions of patient ...

Page 55: ...00 0043 00 Rev 4 Chapter 2 Site Preparations This chapter provides the information required to plan and prepare for the setup of an Invenia ABUS 2 0 Included are descriptions of the facility and electrical needs to be met by the purchaser of the Invenia ABUS 2 0 ...

Page 56: ...nclude cooling needed for lights people or other equipment in the room NOTE Each person in the room places an additional 300 BTU h demand on the cooling system Lighting Bright light is needed for Invenia ABUS 2 0 setup updates and repairs However operator and patient comfort may be optimized if the room light is subdued and indirect Therefore a combination lighting system dim bright is recommended...

Page 57: ...e Invenia ABUS 2 0 without extension cords Other outlets adequate for the external peripherals medical and test equipment needed to support this Invenia ABUS 2 0 must also be present within 1 m 3 2 ft of the Invenia ABUS 2 0 Electrical installation must meet all current local state and national electrical codes Unit power plug Refer to Chapter 9 for Power Plug part numbers If the Invenia ABUS 2 0 ...

Page 58: ...ronous asynchronous or aperiodic transients Table 2 2 Power Stability Requirement Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 0 5 cycle Mains power quality should be that of a typical commercial or hospital environment 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30...

Page 59: ...lation Possible EMI sources should be identified before the Invenia ABUS 2 0 devices are set up Electrical and electronic equipment may produce EMI unintentionally as the result of a defect Some of these sources include medical lasers scanners cauterizing guns computers monitors fans gel warmers microwave ovens light dimmers mobile phones in house wireless phones DECT phones wireless computer keyb...

Page 60: ...updating the Ultrasound system replace all covers and tighten all screws Any cable with an external connection requires a magnet wrap at each end Install all covers Loose or missing covers or Radio Frequency gaskets allow radio frequencies to interfere with the ultrasound signals Replace broken Radio Frequency gaskets If more than 20 or a pair of the fingers on an Radio Frequency gasket are broken...

Page 61: ...qualified personnel The products involved and the accompanying electrical installations are highly sophisticated and special engineering competence is required All electrical work on these products must comply with the requirements of applicable electrical codes The purchaser of GE equipment must only utilize qualified personnel to perform electrical servicing on the equipment The desire to use a ...

Page 62: ... location Door opening is at least 76 cm 30 in wide Proposed location for Ultrasound system is at least 0 5 m 1 5 ft from the wall for cooling Power outlet and place for any external peripheral are within 2 m 6 5 ft of each other with peripheral within 1 m of the Ultrasound system to connect cables Power outlets for other medical equipment Power outlets for test equipment within 1 m 3 2 ft of Ultr...

Page 63: ...s around the equipment Ensure that the following is provided for the new system A separate power outlet with a minimum of a minimum 10 amp circuit breaker for 100 240 VAC Take precautions to ensure that the console is protected from electromagnetic interference Precautions include Operate the console at least 5 meters 15 feet away from motors typewriters elevators and other sources of strong elect...

Page 64: ...separate properly rated outlet Under no circumstances should the AC power plug be altered changed or adapted to a configuration rated less than specified Never use an extension cord or adapter plug To help assure grounding reliability connect to a hospital grade or hospital only grounded power outlet CAUTION Use caution to ensure that the power cable does not disconnect during system use If the sy...

Page 65: ...Layout The device can be place at various positions around the exam table The following figure shows the recommended clearance around the table Figure 2 1 Position A Desired Footprint Maximum arm reach is 40 0 76 m or 30 clear side space recommended 0 61 m or 24 clear front and back space recommended ...

Page 66: ...Site Preparations 2 12 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 Room Layout continued Figure 2 2 Invenia ABUS 2 0 ...

Page 67: ...able workflow protocols Image Processing Algorithms Tissue Equalization Algorithm TEA Speckle Reduction Nipple Shadow Compensation NSC Breast Border Detection Chest Wall Detection Acquisition Scout Images Transverse Plane Real time Coronal Plane Static for Nipple Placement DICOM 3 0 Compliant Worklist DMWL Modality Performed Procedure Step MPPS Store SCU 10 100 1000 Base T Ethernet User Replaceabl...

Page 68: ... Compression between 5 20 lbs 2 25 9 7 kg Integrated extra wide transducer C15 6XW Reverse CurveTM Frequency Range 6 15 MHz Aperture Length 15 3 cm Transducer Travel Distance 16 9 cm Number of Elements 768 Element Pitch 0 20 mm Out of plane Aperture 3 5 mm Transducer Bandwidth 85 Imaging Depth Up to 5 0 cm Single Use Stabilization Membrane Single Volume Acquisition in less than 60 Seconds Multi Ro...

Page 69: ...ootprint 4 2 sq ft 0 39 sq m Weight 227 lbs 103 kg Articulating Arm Reach max 39 inches 100 cm Main Voltage 100 240 VAC Maximum Current 10 amps Mains Frequency 50 60 Hz SSD Data Capacity 200 GB approximately 200 Studies with Storage Status Indicator Study Transfer Auto and Manual Display 17 High Resolution LCD Touch Screen Cart Mobile platform with 4 wheel steering and braking Operating System MS ...

Page 70: ... the operator with clinically useful features for moving images and patient information over a hospital network Examples of DICOM services include the transfer of images to remote viewers for viewing or transferring images to remote printers As an added benefit transferring images in this manner frees up the on board monitor and peripherals enabling viewing to be done while scanning continues With...

Page 71: ...ure that there are no spaces in any field of the form Entries must include A host name local port number AE Title IP address and Net Mask for the Ultrasound system The IP addresses for the default gateway and other routers at the site for ROUTING INFORMATION The host name IP address port and AE Title for each device the site wants connected to the Ultrasound system for DICOM APPLICATION INFORMATIO...

Page 72: ...s and external monitors usually exceed allowable leakage current limits and when plugged into separate AC outlets are in violation of patient safety standards Suitable electrical isolation of such external AC outlets or providing the device with extra protective earth will be required in order to meet UL60601 1 and IEC60601 1 IEC60601 1 1 standards for electrical leakage ...

Page 73: ... normally cared for the patient vicinity is the space with surfaces likely to be contacted by the patient or attendant who can touch the patient This encloses a space within the room 1 83 m 6 ft beyond the perimeter of the bed examination table dental chair treatment booth and the like in its intended location and extending vertically 2 29 m 7 5 ft above the floor 1 Patient environment ...

Page 74: ...Site Preparations 2 20 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 75: ...ns information needed to install Invenia ABUS 2 0 Included is a procedure that describes how to receive and unpack the equipment and how to file a damage or loss claim How to set up the system and how to check and test the unit transducer and external peripherals for electrical safety are also included in this procedure ...

Page 76: ...OPEN DON T TOUCH THE ULTRASOUND SYSTEM CAUTION To prevent electrical shock connect the unit to a properly grounded power outlet Do not use a three to two prong adapter This defeats safety grounding CAUTION Do not wear the ESD wrist strap when you work on live circuits and more than 30 V peak is present CAUTION Do not operate this unit unless all board covers and frame panels are securely in place ...

Page 77: ...operational temperatures from storage or transport temperatures CAUTION If the Ultrasound system is very cold or hot do not turn on its power until it has had a chance to acclimate to its operating environment CAUTION Operator Manual The User Manual should be fully read and understood before operating the Invenia ABUS 2 0 and kept near the Ultrasound instrument for quick reference ...

Page 78: ...US 2 0 considerable distances or on an incline by one person could result in injury or damage or both Two people are required whenever a part weighing 16 KG 35 lbs or more must be lifted CAUTION Remember to use relevant personal protecting equipment PPE during packing and unpacking Check with your local EHS representative Work gloves are highly recommended to protect your hands while unpacking the...

Page 79: ...inside the package even if the package itself is undamaged Examine all packages Examine package closely at time of delivery as described in the procedure below Table 3 1 Examine all packages Step Task 1 Is damage apparent If YES continue with the instructions in Damage in transportation on page 3 6 If NO continue with the next step 2 Continue with the instructions in Unpacking the Invenia ABUS 2 0...

Page 80: ... damage to the carrier Whether noted or concealed damage MUST be reported to the carrier immediately upon discovery or in any event within 14 days after receipt and the contents and containers held for inspection by the carrier A transportation company will not pay a claim for damage if an inspection is not requested within this 14 day period Invenia ABUS 2 0 Transportation Box Label The Invenia A...

Page 81: ...tup and Basic Service Manual 3 7 4700 0043 00 Rev 4 Invenia ABUS 2 0 Transportation Box Label continued Table 3 2 Package Label Icons Label Icon Purpose Meaning Location Keep this way up Package Fragile Package Keep it away from rain Package 2 levels at most Package ...

Page 82: ...nia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 Humidity Limitation Package Temperature Limitation Package Pressure Limitation Package Table 3 2 Package Label Icons Label Icon Purpose Meaning Location ...

Page 83: ...ials attached to the shipping crate There are two sizes of Invenia ABUS 2 0 package one is 1715x845x1650mm and the other is 1167x905x1807mm CAUTION Wear gloves to protect your hands from wood splinters or metal edges Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration 1 Position the crate to allow room at both narrow ends to unload the Invenia ABUS 2 0 ...

Page 84: ...ia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 2 Locate the pry tool taped to one of the sides of the crate Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 85: ...a Use the pry tool to lift all of the metal tabs along the top of the crate b Lift the crate top until it clears the metal tabs and set aside NOTE Ensure that the metal tabs are straightened until they are vertical or the top will be difficult to remove Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 86: ...lifting the metal tabs along the side of the crate to remove all side panel NOTE Straighten the bottom tabs first and then straighten the tabs on the side panels Use caution when removing the crate side panels Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 87: ...t Invenia ABUS 2 0 System Setup and Basic Service Manual 3 13 4700 0043 00 Rev 4 5 Use a pair of scissors to remove the clear plastic wrapping Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 88: ...Setup 3 14 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 6 Remove the waterproof foil Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 89: ...ia ABUS 2 0 System Setup and Basic Service Manual 3 15 4700 0043 00 Rev 4 7 Remove the accessories box membranes lotion network cable power cord etc Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 90: ... to the crate base Ratchet Strap Release Instructions a To release pull and hold release tab on top assembly to override ratcheting function b Open ratchet until it is completely open and flat c Grab webbing from non fixed side and pull to release webbing Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 91: ...nt Invenia ABUS 2 0 System Setup and Basic Service Manual 3 17 4700 0043 00 Rev 4 9 Remove the ramps from both sides of the Invenia ABUS 2 0 Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 92: ... attach the ramps to the end of the crate with the black hook and loop straps CAUTION Ensure that the ramps are positioned with the white bounding boards outside of the black straps These boards keep the wheels on the ramp Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 93: ...S 2 0 System Setup and Basic Service Manual 3 19 4700 0043 00 Rev 4 11 Unlock the caster wheels and then carefully move the Invenia ABUS 2 0 down the ramp Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 94: ...e Manual 4700 0043 00 Rev 4 12 Remove the Scan Arm Assembly protective foam Then use a pair of scissors to cut the cable ties holding the protective Display Monitor foam Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 95: ...Service Manual 3 21 4700 0043 00 Rev 4 13 Move up the Scan Arm Assembly then remove the Scan Arm Assembly and Display monitor protective foam 14 Remove the Tube Covers protective foam Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1650mm Step Description Illustration ...

Page 96: ...re the Scan Head and Scan Arm PRIOR to moving the Invenia ABUS 2 0 Failure to do so may cause the Scan Head and Scan Arm to swing around the unit and cause personal injury or cause damage to the Scan Head or other equipment 17 Remove all of the packaging and place the removed packaging back into the crate to store for possible future use Table 3 3 Unpacking the Invenia ABUS 2 0 for Size 1715x845x1...

Page 97: ... 2 0 System Setup and Basic Service Manual 3 23 4700 0043 00 Rev 4 Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration 1 Position the crate to allow room which have enough space to unload the Invenia ABUS 2 0 ...

Page 98: ...2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 2 Unlock 4pcs Butterfly Lock open the package door and put it down carefully Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 99: ...wo accessory boxes to the crate base Ratchet Strap Release Instructions a To release pull and hold release tab on top assembly to override ratcheting function b Open ratchet until it is completely open and flat c Grab webbing from non fixed side and pull to release webbing Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 100: ...Setup 3 26 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 4 Take out the accessory box Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 101: ... 2 0 System Setup and Basic Service Manual 3 27 4700 0043 00 Rev 4 5 Remove the baffle then untie the nylon cable which tie to seal the high barrier PE bag Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 102: ...ystem Setup and Basic Service Manual 4700 0043 00 Rev 4 6 Unlock the caster wheels and then carefully move the Invenia ABUS 2 0 down the ramp Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 103: ...t Invenia ABUS 2 0 System Setup and Basic Service Manual 3 29 4700 0043 00 Rev 4 7 Use a pair of scissors to remove the clear plastic wrapping Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 104: ...ce Manual 4700 0043 00 Rev 4 8 Remove the Scan Arm Assembly protective foam Then use a pair of scissors to cut the cable ties holding the protective Display Monitor foam Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 105: ... Service Manual 3 31 4700 0043 00 Rev 4 9 Move up the Scan Arm Assembly then remove the Scan Arm Assembly and Display monitor protective foam 10 Remove the Tube Covers protective foam Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1807mm Step Description Illustration ...

Page 106: ...re the Scan Head and Scan Arm PRIOR to moving the Invenia ABUS 2 0 Failure to do so may cause the Scan Head and Scan Arm to swing around the unit and cause personal injury or cause damage to the Scan Head or other equipment 13 Remove all of the packaging and place the removed packaging back into the crate to store for possible future use Table 3 4 Unpacking the Invenia ABUS 2 0 for Size 1167x905x1...

Page 107: ...The packing materials for Invenia ABUS 2 0 are recyclable The Transportation Box is made of spruce or similar material PHYTOSANITARY CERTIFICATE included in all shipments to The People s Republic of China Lever locking hinges are made of zinc plated steel The inner reinforcements are made of Ethafoam Polyethylene foam The plastic foil is made of LDPE Low Density Polyethylene ...

Page 108: ...the effects of Electro Magnetic Interference EMI Many of the covers shields and screws are provided primarily to protect the device from image artifacts caused by this interference For this reason it is imperative that all covers and hardware are installed and secured before the unit is put into operation See EMI limitations on page 2 5 for more information about EMI protection The Invenia ABUS 2 ...

Page 109: ...Preparing for Setup Invenia ABUS 2 0 System Setup and Basic Service Manual 3 35 4700 0043 00 Rev 4 Warning Label Locations Figure 3 2 Rear Panel Label Location ...

Page 110: ... of the testing laboratory product category safety standard to which conformity is assessed and a control number 5 Authorized European Representative address 6 BF Applied Part 7 Prescription Device For U S A Only 8 Identification and Rating Plate USA Asia 120V console 9 CISPR Emissions Label Device and transducer IP Code 10 Mercury Warning Label 11 WEEE Symbol 12 Possible shock hazard Do not remov...

Page 111: ...rer s name and address Rating Plate Identification and Rating Plate Date of manufacture Rating Plate Serial Number Rating Plate Catalog Number Rating Plate Type Class Label Used to indicate the degree of safety or protection Rating Plate United States only Prescription Requirement label Rating Plate Use two people to transport device on inclines This label also indicates the device weight Rating P...

Page 112: ...ator manual or other instructions when complete information cannot be provided on the label Rating Plate Symbol indicating that the Instructions for Use are supplied in electronic form eIFU Rating Plate General Warning Sign Rating Plate Equipment weight 103 kg 227 lbs Rating Plate Patents US 7556602 CN100471457C Rating Plate Mains OFF indicates the power off position of the mains power breaker Rea...

Page 113: ...land Listing Mark Monogram Rating Plate This product consists of devices that may contain mercury which must be recycled or disposed of in accordance with local state or country laws Within this device the backlight lamps in the monitor display contain mercury Rating Plate Product Label Unique Device Identification UDI Label The UDI label consists of a series of alpha numeric characters and barcod...

Page 114: ...E OF OPENING THE AC GROUND LINE I E METER S GROUND SWITCH IS OPEN DON T TOUCH THE ULTRASOUND SYSTEM Electrical Hazard To prevent electrical shock connect the unit to a properly grounded power outlet Do not use a three to two prong adapter This defeats safety grounding Electrical Hazard Do not wear the ESD wrist strap when you work on live circuits and more than 30 V peak is present ...

Page 115: ...ins Power Switch on the rear of the system Refer to the Invenia ABUS 2 0 Basic User Manual part number 4700 0041 00 for more information CAUTION Do not operate this unit unless all board covers and frame panels are securely in place System performance and cooling require this CAUTION If the Ultrasound system is very cold or hot do not turn on its power until it has had a chance to acclimate to its...

Page 116: ...who connects additional equipment to the signal input part or signal output part of Invenia ABUS 2 0 configures a medical system and is therefore responsible that the Invenia ABUS 2 0 device complies with the requirements of the valid version of IEC60601 1 1 If in doubt consult the technical service department or your local representative for GE Connection from Invenia ABUS 2 0 to a DICOM destinat...

Page 117: ...back panel of the Display and one on the back panel of the chassis lower left next to the Ethernet port Figure 3 4 USB Port on the Display Figure 3 5 USB Port on the Chassis NOTE USB Flash Drives approved for Invenia ABUS 2 0 are verified for EMC performance according to EN55011 class B The use of any other USB Flash Cards will compromise this verification and may cause interference on Invenia ABU...

Page 118: ...ked down no anti virus software is required Anti virus software is not recommended to be placed on the Invenia ABUS 2 0 No alterations or modifications can be done via software on this medical device unless outlined and approved by the manufacturer Alterations or additions to software of the Invenia ABUS 2 0 voids all warranties and claims ...

Page 119: ...ed on the right front cover 1 Switch ON the Power Mains Switch at the rear of the unit 2 Press once on the On Off button on the Invenia ABUS 2 0 to boot the unit Power shut down When you switch off the unit the system performs an automatic shutdown sequence Press the On Off Standby button to initiate the shutdown sequence WARNING DO NOT unplug the power cord until after the complete shutdown proce...

Page 120: ...the system See Switch ON the AC Power to Invenia ABUS 2 0 on page 3 45 Logging in as Admin 1 Login with your Service Account a Type Admin b Enter your password When the system boots up from the Service Login three icons appear in the bottom right corner of the Touch Screen Minimize minimizes the Invenia ABUS 2 0 application software to display the Windows desktop This icon is available only with t...

Page 121: ...m the factory Use this procedure only if calibration is noticeably offset 1 Tap the Configuration icon to display the General configuration screen and tap the System tab 2 Tap the Calibrate Screen button to open the calibration function Figure 3 7 Calibrate Screen in System Configuration 3 Follow the onscreen instructions or tap the X in the upper right corner to close the configuration screen ...

Page 122: ...be set from the System Configuration screen 1 Tap the Configuration icon to display the General configuration screen and tap the System tab 2 Tap the Institution Name button to open the screen Figure 3 8 Institution Name in System Configuration 3 Follow the onscreen instructions or tap the X in the upper right corner to close the configuration screen ...

Page 123: ...00 Rev 4 Setting up Time and Date Setting 1 Tap the Configuration icon to display the General configuration screen and tap the System tab 2 Tap the Clock Setting button to open the Windows clock setting function Figure 3 9 Clock setting in System Configuration Figure 3 10 Windows Date and Time Settings ...

Page 124: ...inued 3 Click on Change time zone and select appropriate time and location Click Ok to close Time Zone Settings 4 If necessary click on change date and time Click on OK to retain changes Figure 3 11 Select time zone 5 Continue to the next configuration step or tap the X in the upper right corner to close the configuration screen ...

Page 125: ...k 1 Tap the configuration icon then the System tab Figure 3 12 System Configuration 2 Click on the Network Setting button to open the Windows Connectivity screen 3 Double click the Local Area Connection box The Local Area Connection Status pop up appears Figure 3 13 Windows Connectivity Screen The Local Area Connection Status pop up appears ...

Page 126: ...nual 4700 0043 00 Rev 4 Setting up the Windows network continued 4 On the Local Area Connection Status pop up select Properties from the lower left hand corner of the pop up Figure 3 14 Local Area Connection Status Pop Up The Local Area Network Properties pop up appears ...

Page 127: ...etting up the Windows network continued 5 From the Local Area Network Properties pop up select Internet Protocol Version 4 TCP IPv4 The Internet Protocol Version 4 TCP IPv4 Properties pop up appears Figure 3 15 Local Area Network Properties Pop Up The Internet Protocol Version 4 TCP IPv4 Properties pop up appears ...

Page 128: ...he Windows network continued 6 From the Internet Protocol Version 4 TCP IPv4 Properties pop up select the Use the following IPv4 address radial button Figure 3 16 Protocol Version 4 TCP IPv4 Properties Pop Up 7 Type in the following information IP address IPv4 address Subnet prefix length Default gateway ...

Page 129: ... Connectivity between Invenia ABUS 2 0 and destinations 1 Refer to the Site Survey Planner for additional information 2 Touch the Invenia ABUS 2 0 configuration icon then the General tab 3 Touch each Server button and enter the appropriate IP address and port numbers 4 Touch the Destination button to add a new destination ...

Page 130: ...the configuration gear icon in the lower right hand corner of the screen Then select the desired Configuration Menu by touching one of the following buttons on the left side of the menu General Scanning Protocols Worklist Storage System Service only displays when Service logs in with the Service Login and Password Post Processing About Figure 3 17 General Menu ...

Page 131: ...his version of the Proprietary Service Manual 1 Worklist server location See Setting up Connectivity between Invenia ABUS 2 0 and destinations on page 3 55 for more information 2 MPPS Server location 3 Destinations single or multiple 4 User Interface operating language 5 Manage System Storage The Status gauge displays the Invenia ABUS 2 0 hard disk capacity 250GB 6 Acoustic Power 7 Scan depth 4 0c...

Page 132: ...installation The user can then select the destination that the exam will be transferred to from the predefined worklist at the time exams are started 1 Manually record all the IP addresses and port information of the destinations you will be pushing files to 2 Sign in with your service account on the Invenia ABUS 2 0 To add a destination a Touch the Configuration button and on the General tab touc...

Page 133: ...ect it as part of performing exams Figure 3 20 Destination Device d Enter the AE Title IP Address and Port e Touch the Return button to save the changes NOTE Export Images Settings Unless customer is planning on reading the Invenia ABUS 2 0 images on PACS do not modify the default settings To delete a destination a Touch the Configuration button and on the General tab touch the Destination button ...

Page 134: ...ion for new exam The default destination is the last one to be selected in the destination configuration shown as highlighted Any destination configured in the destination list can be selected prior to completing the exam information manual or worklist The drop down list is shown below Figure 3 21 Selecting destination ...

Page 135: ...ual 3 61 4700 0043 00 Rev 4 User selection of destination to resend exam a Display the completed exams list b Touch an exam that needs to be resent to a different destination c Touch the Resend button d Select the desired destination from the displayed list Figure 3 22 Completed Exams ...

Page 136: ...ct a language from the Interface Language Dropdown List 2 At the prompt please restart for language changes to take effect power down the system by pressing the power button on the front of the unit 3 Power on the system back on for the Interface Language selection to be applied The onscreen keyboard will now display any language specific characters and user prompts and displays will be in the sel...

Page 137: ... based on user preference Default settings are US date format MM DD YY and 12 hour clock HH MM am pm To set the Date and Time 1 Touch the Configuration button 2 On the System tab select the date and time display format from the dropdown lists of Date and Time respectively Figure 3 24 Date and Time Format Date Formats Time Formats 07 30 1999 06 30 20 PM 12 Hour Clock 30 07 1999 07 30 99 18 30 20 24...

Page 138: ... preset workflow protocols Perform Exam Starting on the patient s right Perform Exam Starting on the patient s left Perform complete exam from only the patient s right side right side of the bed only Perform complete exam from only the patient s left side left side of the bed only Specify location of the transducer s start position Figure 3 25 Scanning Protocol Configuration Menu ...

Page 139: ...onfiguration menu allows you to specify how the DICOM Worklist is displayed Date Filter Today This Week This Month Modality Filter Ultrasound ABUS All Optional Worklist Columns Procedure Referring Physician Accession Number Study ID Default Select Page Worklist Work Item Input Procedure DICOM Tag Administrator Figure 3 26 Worklist Configuration User ...

Page 140: ...edure Step is received from the Modality Worklist A complementary service to Modality Worklist Modality Performed Procedure Step MPPS enables a modality to send a report about a performed study including data about the acquired images begin end time duration type of study etc This facilitates better coordination of image storage servers by providing the server with a list of objects to send prior ...

Page 141: ...en the Invenia ABUS 2 0 will require exam data to be removed from the hard disk The Auto Delete Shipped Data lets you specify the frequency to have exam data deleted from the Invenia ABUS 2 0 hard disk after it has already been successfully transfer to an imaging viewer The following information is displayed Storage Status Storage Forced Manual Cleanup 80 85 90 Auto Delete Shipped Data Never After...

Page 142: ... out of the image data folder Deletes any study on the Invenia ABUS 2 0 Keep 16 bit data ALWAYS set this to OFF Export Anonymization On Off When you export patient data to a USB drive patient demographic information is removed GPU Speed Speed of the GPU Temperature Temperature of GPU and Motherboard Export and Import Configuration Export to USB Exports system configuration settings to USB Import f...

Page 143: ... 0 System Setup and Basic Service Manual 3 69 4700 0043 00 Rev 4 About Page The About Page shows the software version lists 3rd Party Software used on the instrument It also provides the online user manual through the Help key Figure 3 30 About Page ...

Page 144: ...confirm that the Network Indicator is green Figure 3 31 Network Indicator 2 Perform a scan on the Invenia ABUS 2 0 3 At the Invenia ABUS 2 0 send a study from the software to the other destination a Turn on system power log in as a typical user and run through the functional checks found in Chapter 4 b Perform a test study and end the exam The study will transfer to the other destination 4 At the ...

Page 145: ... 0 and the peripherals must be kept as part of the original Ultrasound system documentation This ensures that all relevant safety and user information is available during the operation and service of the complete Ultrasound system User s Manual s Check that the correct User Manual s or CD with User Manuals per software SW revision and language for the system is included For a complete list of User...

Page 146: ... Locator Installation Card NOTE The Product Locator Installation Card shown may not be the same as the provided Product Locator card From the factory a sheet with five Product Locator cards for transportation and one for Installation are included Figure 3 32 Product Locator Installation Card Example ...

Page 147: ...ev 4 Chapter 4 Functional Checks This chapter is designed to give the reader the ability to test the Invenia ABUS 2 0 functions During new installations and Update Installations this chapter can be a great asset in determining if the Invenia ABUS 2 0 is working as it should ...

Page 148: ...00 Rev 4 General procedures General Precautions CAUTION Invenia ABUS 2 0 requires all covers Operate this Ultrasound system only when all board covers and frame panels are securely in place The covers are required for safe operation good Ultrasound system performance and cooling purposes ...

Page 149: ...h this section is to keep the most used procedures in one place Checking the Software Version To check the version of software on the Invenia ABUS 2 0 1 Log into the Invenia 2 0 2 0 software 2 Click the configuration icon lower right corner of the Image tab to open the System Configuration page 3 Click About in the left column Figure 4 1 Invenia ABUS 2 0 Software Version ...

Page 150: ... SOCKET WHICH HAS THE PROTECTIVE GROUNDING CONNECTOR DANGER NEVER USE A THREE TO TWO PRONG ADAPTER THIS DEFEATS THE SAFETY GROUND DANGER ENSURE THAT THE POWER CORD AND PLUG ARE INTACT AND THAT THE POWER PLUG IS THE PROPER HOSPITAL GRADE TYPE WHERE REQUIRED CAUTION Invenia ABUS 2 0 Scan Station requires all covers Operate this Invenia ABUS 2 0 Scan Station only when all board covers and frame panel...

Page 151: ...ved slightly 3 Verify that the power cable is without any visible scratches or any sign of damage 4 Verify that the on site mains voltage is within the limits indicated on the rating label near the Power Mains Switch on the rear of the unit 5 Connect the Power Cable s female plug to the Power Inlet at the rear of the unit 6 Verify that the Power Mains Switch is in OFF position if not switch it OFF...

Page 152: ...on the Invenia ABUS 2 0 to boot the unit Figure 4 3 On Off Power shut down When you switch off the unit by pressing the Power button the system performs an automatic shutdown sequence NOTE If the system does not shut down by lightly pressing the Power button you can press and hold down the Power button until the system shuts down ...

Page 153: ...ct the power cord from the wall and from its connector on the rear of the system 4 Disconnect the Ethernet cable from the wall and from its connector on the rear of the system NOTE The system weighs 103 kg 227 lbs CAUTION Secure the articulating arm and monitor prior to moving the system Failure to secure the articulating arm and monitor could cause damage to the arm and or monitor other equipment...

Page 154: ...ation before moving the system is important to minimize potential damage to sensitive components and to avoid safety hazards Review the moving instructions prior to moving the system CAUTION DO NOT park or leave the system unattended on a slope Even if the rear brakes are locked the system may slide down a ramp ...

Page 155: ...le the weight of the system plus the passengers 4 Ensure that the load capacity of the lift a minimum of 103 kg 227 lbs is recommended is capable of handling the weight of the system 5 Ensure that the lift is in good working order 6 Secure the system while it is on the lift so that it cannot roll Use either wood chocks restraining straps or other similar types of constraints Do not attempt to hold...

Page 156: ...e Any movement coupled with the weight of the system could cause it to break loose 10 Secure system with straps or as directed otherwise to prevent motion during transport 11 Prevent vibration damage by driving cautiously Avoid unpaved roads excessive speeds and erratic stops or starts At the new location When the unit is in place at a new location 1 Lock the wheel brakes 2 Position the Articulati...

Page 157: ...00 Rev 4 Where are the User Manuals and the Service Manual Both the User Manuals and the Service Manual may be downloaded from the Common Documentation Library You can download manuals from the Common Documentation Library http www3 gehealthcare com en Support Support_Documentation_Library ...

Page 158: ...unctional Check Confirm that the system Powers on when you press the On Off Standby control That the transducer moves across the Scan Head Assembly That the software runs through its initialization And that each user type User or Admin can successfully login to the system Power Shut Down Functional Check Confirm that the system exits the application and powers down Transducer Functional Check Ensu...

Page 159: ...maging parameters on the Touch Screen Monitor Images evenly across the entire Touch Screen 3D Volume Functional Checks Confirm that the 3D Volume Gets generated after each Scan View performed Performing the Exam Confirm that the system can Login the User Access the Worklist and or Enter Patient information manually Perform the exam Verify the exam Send the exam to the Workstation PACS Perform Quer...

Page 160: ...ion after compression has been applied Articulating Arm Functional Checks Ensure that the Articulating Arm Can be repositioned easily Can be moved up down with ease Can be locked into position for transport Can support the Scan Head Assembly Touch Screen Monitor Functional Checks Ensure that the Touch Screen Monitor Can be used to adjust the Scan View workflow Can be used to specify Scan Depth Can...

Page 161: ...ice Manual 4 15 4700 0043 00 Rev 4 Connectivity Functional Checks Confirm the following Exams transfer successfully InSite is active DICOM Worklist functions DICOM MPPS functions For additional information see the Invenia ABUS 2 0 Basic User Manual PN 4700 0041 XX ...

Page 162: ...Functional Checks 4 16 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 163: ...p and Basic Service Manual 5 1 4700 0043 00 Rev 4 Chapter 5 Components and Functions Theory This chapter examines the Invenia ABUS 2 0 architecture It first identifies physical elements and then discusses the function of elements ...

Page 164: ... 0 is a device designed to perform ultrasound scanned volume imaging of the breast The system has a cart an articulating display arm with touch screen monitor scan arm and a scan head with an integrated ultrasound transducer The cart holds the Dual Box Chassis housing the two major electronics assemblies the Ultrasound Box and the PC Box Figure 5 1 Invenia ABUS 2 0 Key to numbered items in Figure ...

Page 165: ...for the Locking Ball Joint the Scan Head and the Weight Tower internal motors or solenoids The PC Box communicates with the Scan Head Controller over a USB 2 0 link dedicated for that purpose This USB cable is routed from PC to the Ultrasound Box There its USB signals are routed in a custom non USB connector cable to the Weight Tower and from there up the Arm to the Scan Head A second PC USB link ...

Page 166: ...e Scan Head Control board receives high level commands from the PC and performs the low level local control to drive the scan stepping motor to move a transducer across the breast to acquire a sequence of 2D image slices that together represent a volume of tissue This controller also monitors user interface activity at the Scan Head the pushbuttons and relays the pushbutton states to the PC It als...

Page 167: ...diagram Physical mechanical main elements This section outlines the major pieces in the ABUS 2 0 system Major physical assemblies The system s main physical elements are Base with casters and fan filter Dual Box Chassis contains Ultrasound Box providing front end electronics and PC Box providing back end electronics Service Table and covers Weight Tower providing sliding Scan Arm adjustable compre...

Page 168: ...he cMST board for ultrasound processing MFEPS power board and MPSB Relay Board PC Box containing the computer motherboard and associated components such as GPU and SSD and the ACDC power supply box Controls indicators and display The system controls and their locations are Control Location Endpoint ON OFF Power Switch on chassis lower This connects to the PC motherboard Display Touch Screen on erg...

Page 169: ...al wire in the transducer cable back to the Ultrasound Box for processing The PC the GPU card convert the digital scan data into image form The images are shown on the operator monitor and are stored in the PC memory in the SSD solid state drive From there the images can be sent to a compatible image viewer such as the GE Workstation for ABUS 2 0 Image handling For imaging additional image enhance...

Page 170: ...eral image data flow Image file management Images are placed in data files for a patient These files are automatically stored on a solid state drive in the PC They can be copied over Ethernet to a separate image viewing device such as a GE Workstation for image review and diagnosis or to a USB drive or to a PACS for storage ...

Page 171: ...partment for the computer PC components and main power supply The Ultrasound Box and the PC Box are each separately removable for servicing This can be done after removing the outside covers of the Dual Box Chassis Figure 5 4 Dual Box Chassis The Dual Box chassis design has upwards vertical airflow in all compartments to cool the ultrasound components the PC Box s Motherboard and GPU and the power...

Page 172: ...y the cMST board using an I2C interface The 12 VDC power for the fan board comes from the MFEPS board Figure 5 5 Ultrasound Box fan tray Table 5 1 Main components in the Ultrasound Box Component Purpose cMST board Provides ultrasound 128 channel processing MFEPS board Provides power to the cMST board and the Scan Head and Weight Tower Motor Control Interface daughterboard on the MFEPS board Routes...

Page 173: ... on the touchscreen monitor PC box System control and digital computing functions are handled by the components in this chassis The PC Box contains a computer motherboard with CPU RAM solid state drive and various support boards Mechanical design The PC Box sits vertically with air flow coming in from the bottom Air is pulled up through the box by fans at the top The box is removable as a single o...

Page 174: ...rocessing The GPU provides a DVI output for the touchscreen monitor This GPU output connector is adjacent to the I O Panel at the top of the PC Box Table 5 2 PC Box components Component Purpose ACDC input box Handles AC line power input has main power switch with breaker and line filter Connects to ACDC Box ACDC box Contains ACDC Power Supply feeding the ATX Power Control board PWA that distribute...

Page 175: ...Head and the motor control board in the Weight Tower The PC motherboard USB ports used for this are connected by cables to the Ultrasound Box MFEPS board USB ports dedicated for this An additional normal USB 2 0 port connects the PC to the Ultrasound Box s MFEPS power supply to allow the PC to monitor MFEPS status Ethernet network port The Ethernet port on the PC I O panel is cabled to the NET and...

Page 176: ...r CPU operation and lifetime GPU airflow The GPU is the hottest component in the PC Box Therefore its longevity depends on having sufficient cooling air flow For this reason it is important to keep the air filter clean Weight Tower This section first identifies the purpose of the Weight Tower describes key functions lists the major components and then describes the Weight Tower operation Key funct...

Page 177: ...er supports compression through its ability to have the operator command more or less pressure by pressing the adjustment buttons on the right handle The Tower mechanism supports the goal of controlling the compression applied to the patient during an ultrasound examination with the goal of keeping it nearly constant during a scan The following steps outline the sequence for scan setup and pressur...

Page 178: ...d at its base and then balances the weights to create the desired compression step value Vertical locking The system does vertical locking so the Scan Head Assembly cannot move vertically during the scan Also the system sends a signal commanding the Ball Joint to lock position so that the Scan Head cannot rotate during the scan Weight balancing After vertical locking the system then balances the w...

Page 179: ... assembly 5 Scan Head This assembly is comprised of the lower arm tubing 1 from the Weight Tower a hinge 2 at the top upper arm tube 3 ball joint mechanism 4 for angular adjustment of Scan Head and the Scan Head 5 The Scan Arm can be slid up or down to position the Scan head and rotated by means of the Hinge The Ball Joint on the end of the Scan Arm enables the operator to swivel the Scan Head and...

Page 180: ...h enables the whole Scan Arm to be raised or lowered easily by an operator The weight assembly also provides compression adjustment functions Hinge assembly The top of the Lower Tube holds the Hinge Assembly 2 that enables horizontal rotation swiveling of the Upper Tube around its vertical center The hinge moves freely but is not loose and unstable The hinge does not lock Ball Joint The bottom of ...

Page 181: ...nsducer over the membrane which the system presses against the surface of the breast with adjustable compression To prepare for a scan the operator applies lubricating medium lotion or gel to the breast This acoustically couples the tissue through the mesh to the Transducer and lubricates the Transducer s motion across the surface After a scan the operator must discard the membrane assembly and ca...

Page 182: ... Setup and Basic Service Manual 4700 0043 00 Rev 4 Figure 5 8 Scan Head Assembly 1 Buttons Begin Stop Scan 2 Transducer 3 Buttons Increase Decrease compression 4 Single Use Stabilizing Membrane 5 Scan Head Assembly Cover 6 LED Lights 7 Multi Axis Ball Joint Lock ...

Page 183: ...in the scan the Transducer is moved to 2 cm from the center in either direction of the Scan Head Assembly This is so the Scan Head Assembly can be centered on the patient s nipple Figure 5 9 Transducer with Positioning Arrows Arrows on the sides of the Transducer indicate where to position the breast nipple on the Transducer for different View Types Lateral Anterior Posterior and Medial Arrows ide...

Page 184: ...e the scan cannot begin until the membrane has been properly mounted Handles and operator control pushbuttons The Scan Head has a left and a right handle These are used for head positioning and for the operator to adjust compression either manually or by pushbutton The left handle has two pushbuttons one to start a scan and one to abort a scan The right handle has two pushbuttons one to increase c...

Page 185: ...his assembly comprises the lower arm also known as the extension arm the upper arm which is rotatable and which swivels from side to side called the Articulating Display Arm and the touchscreen monitor Figure 5 10 Display Arm and Monitor The components of the arm are 1 Shoulder joint 2 Extension arm 3 Elbow joint 4 Lift arm 5 Wrist joint 6 Display joint ...

Page 186: ... switch with thermal circuit breaker Scan Head controls The two handles on the Scan Head provide operator control pushbuttons The left handle buttons are start scan green button stop abort scan red button The right handle buttons are decrease Scan Head pressure up arrow increase Scan Head pressure down arrow Touchscreen The Touchscreen is touch sensitive and supports the system software detecting ...

Page 187: ...ditions and present graphics showing details about Scan Head Assembly positioning such as need for pressure adjustment or position relative to the patient Additional indicators and illumination Scan Head Illumination The Scan Head has two rows of white LEDs left and right that light up the patient work surface breast tissue Other indicators Inside the Scan Head electronics compartment is a blue LE...

Page 188: ... 26 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 External access ports The base of the rear chassis cover has an externally accessible Ethernet port and a USB port Figure 5 11 Ethernet and USB service port ...

Page 189: ...in power switch in the ACDC Input assembly on the side of the PC Box must be turned on Service Related Diagnostics A section of the Service Desktop application provides machine and system diagnostics The system monitors a number of items and it logs and reports their fault conditions Monitored items include fans temperatures of cMST board MFEPS and motherboard voltages at key boards run status of ...

Page 190: ...y nearest the Scan Head are referred to as front end components GPU Graphics Processing Unit A PC board dedicated to graphics processing LNA Low Noise amplifier An amplifier designed so that it does not introduce much noise into low level signals MCI Motor Control Interface The MCI board in the Ultrasound Box relays control commands originating at the PC for the Scan Head and Weight Tower motors M...

Page 191: ...etup and Basic Service Manual 6 1 4700 0043 00 Rev 4 Chapter 6 Service Adjustments and lubrication This chapter describes how to test and make adjustments to the Invenia ABUS 2 0 You can use these to test the system for errors ...

Page 192: ...etup and Basic Service Manual 4700 0043 00 Rev 4 Service Adjustments This Chapter only covers the components or assemblies that require adjustments for the Invenia ABUS 2 0 System adjustments need to be performed by trained qualified personnel Contact GE for training ...

Page 193: ...hese Dampers move out of position the Drive Screw will become slightly bent and cause this binding sound as the Motor travels toward the end of the Drive Screw Table 6 1 Steps Illustration 1 Looking at the Drive Screw Dampers on the inside of the Scan Head you will find that one or both Dampers will be elongated oval where the Drive Screw goes through it NOTE Do not apply grease to damper or motor...

Page 194: ...tic Performance Lubricant P N 2301 0478 00 Table 6 2 Ball Joint Lubrication Points Steps Illustration 1 Apply a thin film of lubricant to lower half of the nickel plated ball joint while tipping Scan Head in all four directions Clean off any excess lubricant from the painted surfaces 2 Remove the Scan Head Membrane if in place Scan Head Cassette from the Scan Head Clear Cast Cover 3 Rest the Scan ...

Page 195: ... Diagnostics Troubleshooting This chapter describes how to setup and run the tools and software that help maintain image quality and system operation Very basic host system and board level diagnostics are run whenever power is applied Some Service Tools may be run at the application level ...

Page 196: ...SENT IN THIS EQUIPMENT USE EXTREME CAUTION WHEN HANDLING TESTING AND ADJUSTING WARNING IF THE COVERS ARE REMOVED FROM AN OPERATING Invenia ABUS 2 0 SOME METAL SURFACES MAY BE WARM ENOUGH TO POSE A POTENTIAL HEAT HAZARD IF TOUCHED EVEN WHILE IN SHUTDOWN MODE WARNING USE ALL PERSONAL PROTECTION EQUIPMENT PPE SUCH AS GLOVES SAFETY SHOES SAFETY GLASSES AND KNEELING PAD TO REDUCE THE RISK OF INJURY ...

Page 197: ...a ABUS 2 0 being returned to the manufacturer This information is normally collected with Alt D or Gather Logs Navigate to Configuration System About Product Name Invenia ABUS 2 0 From Software record Software Version Software Revision Software Part Number Build Name Build View Build Date Collecting a screen capture with logs The error logs will be collected using Insite Error Logs Crash Log prote...

Page 198: ...ides the Field Service Engineer who services several product lines with a recognizable service interface This section describes the features of the Service Desktop These are the different levels of access to the Service desktop Basic Service access Class A a user locally logged into the machine with Basic Service Access privilege This level provides limited access to Service desktop widgets and ut...

Page 199: ... application software locate and click the light colored GE icon in the Invenia ABUS 2 0 screen to open the Connectivity Menu See the following figure Figure 7 2 Invenia ABUS 2 0 Connectivity Menu NOTE In the Invenia ABUS 2 0 software the customer interface to the Service Desktop is called InSite 3 Click the Insite arrow to open the Service Desktop icons a Service Desktop icon b Gather Logs Alt D ...

Page 200: ...s White InSite connected to GE User can send requests for service but service is not connected White with blue radio waves Service is connected and investigating the problem Red Service desktop is active Service is connected and has disrupted normal processes to troubleshoot the problem 2 Service Desktop Shares an Invenia ABUS 2 0 desktop with a GE Online Service Engineer 3 Gather Logs Opens a Ser...

Page 201: ... 0 System Setup and Basic Service Manual 7 7 4700 0043 00 Rev 4 Licenses BASIC ACCESS Class C With Service Basic Access these are the available options HOME Utilities Delete Files Gather Logs Third Party Licenses Agent Configuration ...

Page 202: ...oubleshooting 7 8 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 Basic Class Access Basic configurations vary depending upon the purchased service level Figure 7 3 Home with Class M Access ...

Page 203: ...When the Invenia ABUS 2 0 has been successfully configured with the back office these elements will have the corresponding values Agent Registered will be Yes Agent Quarantine will be No Agent CRM Verified will be Yes The information on System Information is available to all service class licenses To access System Information navigate to Utility Service Home Figure 7 4 System Information ...

Page 204: ...of the agent Valid values are Yes The agent has more than one device registered with the same CRM Number in the back office No The agent has one device registered with the listed CRM Number in the back office Not Available The agent is not running or has not been configured Agent CRM Verified CRM verified status of the agent Valid values are Yes The agent is verified in the back office No The agen...

Page 205: ...0 Rev 4 Software Status Use Software Status to view general information about the software installed on the Invenia ABUS 2 0 The information on Software Status is available to all service class licenses To access Software Status navigate to Utility Service Home Figure 7 5 Software Status ...

Page 206: ... refreshed in the format hh mm ss Application Installation Date Date the application software was installed The application software includes the Invenia ABUS 2 0 product specific software Base Image Installation Date Date the base image software was installed The base image software includes the Windows operating system and other supporting software Base Image Version Version number of the base i...

Page 207: ...0 0043 00 Rev 4 System Status Use System Status to view status information on the Invenia ABUS 2 0 Specifically do the following The information on System Status is available to Basic access licenses To access System Status navigate to Utility Service Home Figure 7 6 System Status ...

Page 208: ...a graph for the configured monitoring points Voltage Displays the voltage monitoring of the Invenia ABUS 2 0 as normal warning or error using the standard colors and icons Includes voltage out of spec events including an overall count of the event warnings and errors for the last 30 days or last status checkpoint whichever is sooner Bootup Issues Based on the latest occurrence displays all abnorma...

Page 209: ...udes all the vital product data VPD To access Hardware Configuration navigate to Utility Service Home and then under System Status select Hardware Configuration Figure 7 7 Hardware Configuration This table shows all the elements available on Hardware Configuration with descriptions Element DESCRIPTION Component Hardware component Item Parameter with the vital product data VPD Value Actual value of...

Page 210: ...lly use these pages FRU Status Graphs Fan Status To access Temperature navigate to Utility Service Home and then under System Status select Temperature Graphs Graphs displays trend graphs for selected elements which have been selected as key indicators of overall temperature status inside the card rack To access this page under System Status select Temperature and then select Graphs Figure 7 8 Gra...

Page 211: ... Service Manual 7 17 4700 0043 00 Rev 4 Fan Status Fan Status displays the details for each fan The peak level of operation for the fans is 2500 RPM To access this page under System Status select Temperature and then select Fan Status Figure 7 9 Fan Status ...

Page 212: ...n tray Device Device monitoring the parameters Status Status of the fan Valid values are Normal Indicates that the fan is operating within the allowable range Warning Indicates that the fan is operating close to the limit of the allowable range Error Indicates that the fan is operating outside the allowable range Lower Limit Warnings Number of low limit temperature warnings Upper Limit Warnings Nu...

Page 213: ...19 4700 0043 00 Rev 4 Voltage Use Voltage to troubleshoot problems with monitored FRUs and the AC voltage of the Invenia ABUS 2 0 Specifically use these pages FRU Status AC Voltage To access Voltage navigate to Utility Service Home and then under System Status select Voltage ...

Page 214: ... and Basic Service Manual 4700 0043 00 Rev 4 FRU Status FRU Status displays a summary of the voltages for the FRUs being monitored and the details for each FRU To access this page under System Status select Voltage and then select FRU Status Figure 7 10 FRU Status ...

Page 215: ...tatus with descriptions Element DESCRIPTION Name Name of the FRU Status Status of the voltage for the FRU Valid values are Normal Indicates that the voltage is within the allowable range Warning Indicates that the voltage is close to the limit of the allowable range Error Indicates that the voltage is outside the allowable range Lower Limit Warnings Number of low limit voltage warnings Upper Limit...

Page 216: ...ice Sub System Hardware component Rule Code for the alert Alerts are filtered in the back office using rule codes Description Description of the alert log Value Current value read for the associated hardware component Lower Limit Value for the lower limit for the associated hardware component Upper Limit Value for the upper limit for the associated hardware component Severity Severity of the alert...

Page 217: ...al size Orange Available free space is more than 10 and less than 20 of the total size Green Available free space is more than 20 of the total size The information on Disk Drive Space is available to Class C and Class M licenses To access Disk Drive Space navigate to Utility Service Home Figure 7 12 Disk Drive Space This table shows all the elements available on Disk Drive Space with descriptions ...

Page 218: ...iguration Use Network Configuration to view network wired information the full ipconfig details for the network configured with the Invenia ABUS 2 0 The information on Network Configuration is available to Class M licenses To access Network Configuration navigate to Utility Service Home Figure 7 13 Network Configuration ...

Page 219: ...Service Desktop Invenia ABUS 2 0 System Setup and Basic Service Manual 7 25 4700 0043 00 Rev 4 Figure 7 14 Network Configuration with More Details ...

Page 220: ...onnection lpV6 Address Local IP address for the wired network connection Subnet Mask Local subnet mask for the wired network Default Gateway Default gateway for the wired network MAC Address Address for the MAC for the wired network Speed Mbps Speed of the wireless connection Wireless Connection IP Address IP address for the wireless network connection Subnet Mask Subnet mask for the wireless conn...

Page 221: ...ather Logs shortcut on the Windows desktop The information on Gather Logs is available to all service class licenses To gather log files 1 Navigate to Utility second page Service Utilities Gather Logs Figure 7 15 Gather Logs 2 Select one of the following options shown in the following table 3 Click Gather Logs In the resulting dialog box record the location of the log files and click OK 4 When the...

Page 222: ...tdown System To restart the Invenia ABUS 2 0 select Restart System To shut down the application software select Shutdown Application To retain the current setting for Disruptive mode a Select Retain Disruptive Mode b Click Submit Request Third Party License Third Party Software Licenses displays the third party software licenses used as part of the service platform The information on Third Party S...

Page 223: ...tact GE Service System Overheating Clean the filter CAUTION DO NOT operate the system without an air filter Image doesn t transfer from the Invenia ABUS 2 0 system Confirm that the Workstation Network Indicator light is green Shut down both the Invenia ABUS 2 0 and Workstation then 1st reboot the Workstation and 2nd reboot the Invenia ABUS 2 0 Lines in the Image Remove the transducer then reverse ...

Page 224: ...er CAUTION DO NOT operate the system without an air filter Image doesn t transfer from the Invenia ABUS 2 0 system Confirm that the Workstation Network Indicator light is green Shut down both the Invenia ABUS 2 0 and Workstation then 1st reboot the Workstation and 2nd reboot the Invenia ABUS 2 0 Lines in the Image Remove the transducer then reverse it 180 degrees and plug it back in If you still s...

Page 225: ...ommendations on page 7 32 EMI prevention abatement on page 2 6 Overview of types of noise on page 7 34 When talking to the customer try to gather as much information as possible about the conditions when the noise appear Is the noise present all the time after some time of use After how long time at special times of the day or night When at all locations in the hospital or only in one room area fr...

Page 226: ...interference will not occur in a particular installation Possible EMI sources should be identified before the Invenia ABUS 2 0 is installed Electrical and electronic equipment may produce EMI unintentionally as the result of a defect Some of these sources include medical lasers scanners cauterizing guns computers monitors fans microwave ovens light dimmers mobile phones in house wireless phones DE...

Page 227: ...s If more than 20 or a pair of the fingers on an Radio Frequency gasket are broken replace the gasket Do not turn on the Invenia ABUS 2 0 until any loose metallic part is removed Do not place labels where Radio Frequency gaskets touch metal Where applicable never place a label where Radio Frequency gaskets meet the Ultrasound system Otherwise the gap created will permit Radio Frequency leakage Or ...

Page 228: ...full size ground wire from the distribution panel to the Ultrasound outlet Different system Try another Invenia ABUS 2 0 at the same location and look for the same noise If the noise is present on the new system too the noise is most likely from an external source equipment Different location Move the Scan Head Assembly to another location and verify if the noise changes or disappear This may help...

Page 229: ...aring a power line with other equipment Intermittent noise Is there any equipment that is turned on and off near the Invenia ABUS 2 0 Is the noise present all around the clock or only at special occasions Self generated noise noise generated inside the unit Self generated noise may be due to either heat problems hardware problems software problems Heat problems Heat problems are usually starting w...

Page 230: ...he system Dataset is not available The selected patient s dataset is no longer available It cannot be re sent to the workstation Imaging Engine Initializing The system is in the process of starting up Please check the scantype The user must select a scan type before scanning can begin Please input patient information Prompts the user to fill in all patient information fields prior to starting the ...

Page 231: ... is incorrect A valid user name and password must be entered to use the system There are scans missing for this patient Are you sure you want to finish Informs the user that there are scans that have been selected to be completed for the patient and these scans have not yet been completed Prompts user to select whether or not they would like to finish the session before completing all scheduled sc...

Page 232: ...t load report data Informational message Delete confirmation Confirm selection DICOM connection test failed Informational message DICOM connection test passed Informational message Do you want to resume the last saved session Confirm selection Export from DICOM server is not supported Informational message Failed to export users Informational message Please try the operation again Failed to retrie...

Page 233: ...Please try the operation again Printer error Check the printer and try the operation again Report file file name already exists Change export filename Retrieve completed Informational message Retrieving study id Informational message Study doesn t exist Informational message Please try the operation again The Invenia ABUS 2 0 application has encountered a problem Please restart the application The...

Page 234: ...re installation You have images in the data pane Informational message You have images in the data pane Are you sure you want to open a new study Confirm selection You have images pending int he DICOM queue Informational message You must restart Invenia ABUS 2 0 for the configuration changes to take effect Please restart the application Table 7 6 Messages Continued System Message Cause Action to T...

Page 235: ...nual 7 41 4700 0043 00 Rev 4 Invenia ABUS 2 0 Error Log Invenia ABUS 2 0 creates three error logs per day Daily error logs ABUSApp_ serial number date log uct ScannerApp_ serial number date log uct ScannerAppMtCtrLib_ serial number date log uct Figure 7 17 ABUS daily error logs ...

Page 236: ... Rev 4 Figure 7 18 ABUSApp_ serial number date log uct Figure 7 19 ScannerApp_ serial number date log uct Logs information from the Scan Head Assembly Membrane Buttons Pushed Scan Arm i e Ball Joint Lock and Weight Controller motor controller For example ENTER MEMB_DETACHED by Event Membrane attached ...

Page 237: ... Setup and Basic Service Manual 7 43 4700 0043 00 Rev 4 Logs information from the Scan Head Assembly Membrane Buttons Pushed Scan Arm i e Ball Joint Lock and Weight Controller motor controller For example ENTER MEMB_DETACHED by Event Membrane attached ...

Page 238: ... Basic Service Manual 4700 0043 00 Rev 4 Collecting Error Logs Since there is not an ALT D function you might have to download the logs by selecting each individual file under the Log folder Figure 7 20 Downloading Log File Figure 7 21 Example of downloaded error logs ...

Page 239: ...t overlap with old Verasonics VDAS Acquisition codes Thus the error codes related to GEUS and VDAS are unique to each system design Error Code total 5 digits First 1 digit Second 1 digit Third 3 digits 1 ABUSApp related 1 Acquisition related Acquisition error code 2 Scanhead related 001 Scanhead id does not match 3 Renderer related 001 Image renderer initialization failed 4 System status related 2...

Page 240: ...or partially blocked air filter the user is instructed to check the system air filter first If the system continues to overheat the customer places a service call The service team can easily search the Service Manual by the error code and follow the troubleshooting steps check the cMST temperature monitoring readings and run the system diagnostics available in the Service Desktop to determine if t...

Page 241: ...ge supplied by MFESP board The service team can easily search the Service Manual by the error code and follow the troubleshooting steps check the MFESP fan monitoring readings and run the system diagnostics available in the Service Desktop to determine the root cause of the problem The Invenia 2 0 system displays an error information message along with an error code and codes are linked to trouble...

Page 242: ...ScannerApp Init Ball motor init home failed 21005 ScannerApp Init Scanhead controller USB COM port not detected 21006 ScannerApp Init Weight controller USB COM port not detected 21007 ScannerApp Init Scanhead and Weight controller USB COM port not detected 22001 ScannerApp USB Scanhead controller USB COM port not detected 22002 ScannerApp USB Weight controller USB COM port not detected 31000 GEUS ...

Page 243: ...N_SETUP_005 An unknown setup problem occurred System will NOT Scan 35006 GEUS Failure ERR_OVERHEATING_006 The system is overheating The system will shut down soon Please check air filters 35007 GEUS Failure ERR_FAN_FAILURE_007 Fan failure The system will shut down soon 35008 GEUS Failure ERR_VOLTAGE_008 System voltage fault The system will shut down soon 35009 GEUS Failure ERR_POWER_009 Power supp...

Page 244: ...6005 GEUS Info INFO_SYSTEM_SHUTDOWN_005 Do you want to shut down the system 36006 GEUS Info INFO_MAJOR_SETUP_006 A minor setup problem occured Image quality may not be optimal 36007 GEUS Info INFO_BEP_VOL_007 Bep Voltage is out of range 36008 GEUS Info INFO_BEP_FAN_008 Bep Fan is abnormal 36009 GEUS Info INFO_TEMP_009 Bep temperature is out of range 36010 GEUS Info INFO_TRANSDUCER_010 Transducer i...

Page 245: ...Invenia ABUS 2 0 System Setup and Basic Service Manual 8 1 4700 0043 00 Rev 4 Chapter 8 Replacement Procedures This chapter describes how to remove and replace the system s filter and transducer ...

Page 246: ... control of the Invenia ABUS 2 0 power plug 5 Wait for at least 30 seconds for capacitors to discharge as there are no test points to verify isolation 6 Remove disconnect the battery if present Invenia ABUS 2 0 components may be energized WARNING Because of the limited access to cabinets and equipment in the field placing people in awkward positions GE has limited the lifting weight for one person...

Page 247: ... circuits prior to taking the necessary ESD precautions Always connect yourself via an arm wrist strap to the advised ESD connection point located on the rear of the Invenia ABUS 2 0 near the power connector Follow general guidelines for handling of electrostatic sensitive equipment WARNING The waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must b...

Page 248: ...aminated prior to shipment Under no circumstance should a part or equipment with visible body fluids be taken or shipped from a clinic or site for example body coils or an ultrasound transducer The purpose of the regulation is to protect employees in the transportation industry as well as the people who will receive or open this package NOTE The US Department of Transportation DOT has ruled that i...

Page 249: ...al and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact the manufacturer or other authorized disposal company to decommission your equipment Properly dispose of all old or used parts and media according to current policies and procedures Never keep old software or leave old software at the customer site ...

Page 250: ...filter on a monthly basis This will also be performed by the Service Engineer during their normal PM process To clean or replace the Filter Table 8 1 Cleaning the Filter Steps Illustrations 1 Power down the system 2 Remove the filter which is located on the bottom of the Invenia ABUS 2 0 The filter is attached using Velcro 3 Vacuum the filter ...

Page 251: ...tem Powers on when you press the On Off Standby control That the transducer moves across the Scan Head Assembly That the software runs through its initialization That each user type User Admin can successfully login to the system And that the system images the patient successfully 4 Replace the filter velcro side up Table 8 1 Cleaning the Filter Steps Illustrations ...

Page 252: ... off the switch on the Power Entry Module Power Cord Socket then remove the Power Cord Maintain control of the power cord according to local lockout tagout requirements 3 Remove the Scan Head assembly Clear Cast Cover 4 Remove the Stabilizing Membrane 5 Remove the four 4 screws securing the Transducer Cover assembly to the Transducer adapter mounting NOTE There are two 2 screws on either side of t...

Page 253: ...nvenia ABUS 2 0 System Setup and Basic Service Manual 8 9 4700 0043 00 Rev 4 6 Hold the Transducer with one hand and the Transducer Cover assembly with the opposite hand Gently pull the Transducer away from the Transducer Cover ...

Page 254: ...er mounting with one hand and the Transducer Cover assembly with the opposite hand Gently push the Transducer into the Transducer Adapter mounting 2 Insert the four 4 screws 1500 0097 00 into the Transducer Adapter mounting and torque the screws to 10 in lbs 1 15 N m NOTE There are two 2 screws on either side of the Transducer Adapter Mounting 3 Install the Scan Head assembly Clear Cast Cover ...

Page 255: ... B Mode Functional Checks Confirm that the system Performs a B Mode scan Places B Mode imaging parameters on the Touch Screen Monitor Images evenly across the entire Touch Screen 3D Volume Functional Checks Confirm that the 3D Volume Gets generated after each Scan View performed 4 Attach the Stabilizing Membrane 5 Plug the power cord into the Power Entry Module Power Cord Socket and switch the pow...

Page 256: ... Service Manual 4700 0043 00 Rev 4 Performing the Exam Confirm that the system can Login the User Access the Worklist and or Enter Patient information manually Perform the exam Verify the exam Send the exam to the Workstation PACS Perform Query Retrieve process to PACS ...

Page 257: ...ining clip upwards 3 Disconnect the power cord from its receptacle by pulling the power cord straight out To replace the power cord 1 Locate the power cord receptacle on the back of the system 2 Align the power cord prongs to match the receptacle then securely push the cord straight back into the receptacle 3 Pull the steel retaining clip down to retain the plug in the system CAUTION Removing the ...

Page 258: ...afety hazards and degradation in system performance All modification must be done by a GE qualified person WARNING This equipment contains dangerous voltages that are capable of serious injury or death If any defects are observed or malfunctions occur stop operating the equipment and perform the proper action for the patient Inform a qualified service person and contact a Service Representative fo...

Page 259: ...ay Internal Imaging Components Caster Wheels WARNING This equipment contains dangerous voltages that are capable of serious injury or death If any defects are observed or malfunctions occur stop operating the equipment and perform the proper action for the patient Inform a qualified service person and contact a Service Representative for information There are no user serviceable components inside ...

Page 260: ...Replacement Procedures 8 16 Invenia ABUS 2 0 System Setup and Basic Service Manual 4700 0043 00 Rev 4 ...

Page 261: ...Invenia ABUS 2 0 System Setup and Basic Service Manual 9 1 4700 0043 00 Rev 4 Chapter 9 Renewal Parts This chapter lists the renewal parts available for the Invenia ABUS 2 0 ...

Page 262: ...PTION 3D THREE DIMENSIONAL ABUS AUTOMATED BREAST ULTRA SOUND ASSY ASSEMBLY FRU FIELD REPLACEMENT UNIT CTRL CONTROL DMM DIGITAL MULTIMETER EXT EXTERNAL I O INPUT OUTPUT INT INTERNAL LCD LIQUID CRYSTAL DISPLAY PCIe PCI EXPRESS PS POWER SUPPLY PCA PRINTED CIRCUIT ASSEMBLY PWA PRINTED WIRE ASSEMBLY PWR POWER QTY QUANTITY USED PER Invenia ABUS 2 0 SSD SOLID STATE DRIVE ...

Page 263: ... A C Power Cable N America A C Power Cable Europe A C Power Cable China A C Power Cable Brazil A C Power Cable Japan A C Power Cable S Africa India 3787 0008 00 Planar Touch Screen 17 Monitor Table 9 3 Accessory Part Numbers Part Number ECAT Description 5486351 E8365EC PolySonic Ultrasound Lotion Non Sterile 8 5oz dispenser bottles 5489491 E8365EF PolySonic Ultrasound Lotion Non Sterile 1 US gallo...

Page 264: ...Towels with Bleach Clorox Clinell Universal Wipes GAMA Healthcare Ltd 3500 0684 00 Invenia ABUS 2 0 Starter Kit contains Lotion Ultrasound Coupling Pack non sterile 12 pack Invenia ABUS 2 0 Single Use Stabilization Membrane 50 pack Country specific power cords see below Table 9 3 Accessory Part Numbers Part Number ECAT Description ...

Page 265: ...re and Maintenance This chapter describes Care and Maintenance on the Invenia ABUS 2 0 and peripherals These procedures are intended to maintain the quality of the Ultrasound system s performance Read this chapter completely and familiarize yourself with the procedures before performing a task ...

Page 266: ...kept in the same room or near the ultrasound system NOTE Leave a copy of the Ultrasound Equipment Quality Check form with the customer and request that it be kept in the same room or near the ABUS unit Customer Quality Assurance Program Routine quality control testing must occur regularly The same tests are performed during each period so that changes can be monitored over time and effective corre...

Page 267: ...tasks and schedule described in this manual are recommendations only except in the following cases The customer has a service contract with GE to perform maintenance at specific times The customer has a Quality Assurance program that requires additional tasks and or inspections at a different frequency than is recommended in this manual NOTE If preventative maintenance is performed it should be do...

Page 268: ...f the Invenia ABUS 2 0 instrument NOTE The service procedures and recommended intervals shown in the Care and Maintenance Task Schedule are based on average patient load If conditions exist which exceed typical usage and patient load then recommend an increase in periodic maintenance frequencies Table 10 1 Care and Maintenance Schedule Cleaning Disinfecting Screen Cleaner Dry Non abrasive Cleaning...

Page 269: ...ipes Tristel For the following disinfecting wipes C Diff was tested and passed 1 Dispatch Hospital Cleaner Disinfectant Towels with Bleach Clorox 2 Clinell Universal Wipes GAMA Healthcare Ltd Biological Hazard Possible risk of infection Do not handle soiled or contaminated transducer and other components that have been in patient contact Follow appropriate cleaning and surface level disinfecting p...

Page 270: ... been in patient contact Follow appropriate cleaning and surface level disinfecting procedures before handling the equipment Table 10 3 Cleaning the Scan Head Steps Illustrations 1 Remove and dispose of Scan Membrane 2 Use dry non abrasive cleaning cloth to wipe off lotion if present from the Scan Head Assembly Use disinfecting wipes to clean away residual lotion and other debris from the patient ...

Page 271: ...e plastic Clear Cover securely after cleaning 4 Use disinfectant wipe to clean all portions of the transducer and Scan Head Assembly that comes in contact with the patient s breast See note on approved disinfectant wipes on page 10 5 Inspect transducer for wear CAUTION DO NOT use an alcohol based solution to clean the transducer Table 10 3 Cleaning the Scan Head Continued Steps Illustrations ...

Page 272: ...ice Manual 4700 0043 00 Rev 4 Cleaning Air Filter Table 10 4 Cleaning the Air Filter Steps Illustrations 1 Power down the system 2 Remove the air filter which is located on the bottom of the Invenia ABUS 2 0 3 Vacuum the air filter 4 Replace the air filter velcro side up ...

Page 273: ... and service table replacement 8 15 customer assistance 1 24 phone numbers 1 25 customer order verification 3 34 D damage in transportation 3 6 damage in transport i 15 dangerous procedure warnings 1 16 data network setup requirements 2 16 date format 3 63 date setup scan station 3 49 diagnostics troubleshooting 7 1 DICOM network function 2 16 DICOM setup requirements 2 17 disposal used media and ...

Page 274: ...escription 3 37 icons 1 8 icons indicating a special procedure to be used 1 11 if the unit is very cold or hot 2 2 important conventions 1 8 important notices facility needs 2 9 important precautions i 2 indicator light network 3 70 installation card 3 72 installation warnings see setup warnings 3 2 3 40 intermittent noise 7 35 L Label icon description 3 37 label GE cares 3 36 labels transportatio...

Page 275: ...cycling information packing materials 3 33 renewal parts 9 1 abbreviations 9 2 replacement covers 8 15 service table 8 15 replacement procedures 8 1 warnings 8 2 requirements 2 2 returning shipping probes and repair parts 1 27 8 4 revision history i 1 S safety 1 18 electrical practices 1 17 transducer 1 17 human 1 13 safety considerations 1 13 safety precaution messages 1 9 scan station specificat...

Page 276: ...0 Troubleshooting Vital System Information 7 3 troubleshooting 7 1 noise recommendations 7 34 turn on 3 46 types of noise 7 34 typical users of the service manual 1 3 U unpacking 3 4 unpacking instructions 3 9 USB flash card connect 3 43 used media disposal 8 5 used parts disposal 8 5 user manual 4 11 V verify customer order 3 34 voltage settings 3 41 W warnings dangerous procedures 1 16 power on ...

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