GE LOGIQ E9 User Manual Download Page 5

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LOGIQ E9

–

User Guide

i-3

Direction 5454884-100 English

Rev. 1

Regulatory Requirements

Conformance Standards

The following classifications are in accordance with the IEC/
EN 60601-1:6.8.1:

•

According to 93/42/EEC Medical Device Directive, this is
Class IIa Medical Device.

•

According to IEC/EN 60601-1,

•

Equipment is Class I, Type B with BF or CF Applied
Parts.

•

According to CISPR 11,

•

Equipment is Group 1, Class A ISM Equipment.

This product complies with the regulatory requirement of the
following:

•

Council Directive 93/42/EEC concerning medical devices:
the CE label affixed to the product testifies compliance to
the Directive.

The location of the CE marking is shown in the Safety
chapter of this manual.

Authorized EU Representative

European registered place of business:

GE Medical Systems Information Technologies GmbH

(GEMS IT GmbH)

Munzinger Strasse 3, D-79111 Freiburg, GERMANY

Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233

Summary of Contents for LOGIQ E9

Page 2: ...ual is a reference for the LOGIQ E9 It applies to Version R4 software for the LOGIQ E9 ultrasound system 0459 GE Healthcare P O Box 414 Milwaukee Wisconsin 53201 U S A Asia Pacific Latin America North America GE Ultraschall Deutschland GmbH Co KG Beethovenstrasse 239 Postfach 11 05 60 D 42655 Solingen GERMANY TEL 49 212 28 02 208 FAX 49 212 28 02 431 ...

Page 3: ...gement If you need to know the latest revision contact your distributor local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698 REV DATE YYYY MM DD REASON FOR CHANGE Rev 1 2012 11 09 Initial Release PAGE NUMBER REVISION NUMBER PAGE NUMBER REVISION NUMBER Title Page Rev 1 Chapter 2 Rev 1 Revision History Rev 1 Chapter 3 Rev 1 Reg...

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Page 5: ...cording to CISPR 11 Equipment is Group 1 Class A ISM Equipment This product complies with the regulatory requirement of the following Council Directive 93 42 EEC concerning medical devices the CE label affixed to the product testifies compliance to the Directive The location of the CE marking is shown in the Safety chapter of this manual Authorized EU Representative European registered place of bu...

Page 6: ...devices IEC 60601 2 37 Medical electrical equipment Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment International Organization of Standards ISO ISO 10993 1 Biological evaluation of medical devices Underwriters Laboratories Inc UL an independent testing laboratory UL 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Canadian...

Page 7: ...ific Approval JAPAN MHLW Certified Number 220ABBZX00177000 KOREA KFDA License 09 180 USA AND TERRITORIES Importer Information Turkey ITHALATÇI PENTA ELEKTRONIK MEDIKAL SISTEMLER SAN VE TIC A S HOSDERE CAD FUAR SOK 5 3 Y AYRANCI ANKARA DANGER The following optional features ARE NOT available in the USA and its territories Elastography Quanitfication Contrast Enhanced Ultrasound Breast Measure Assis...

Page 8: ...i 6 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 ...

Page 9: ... 7 Moving the System Before moving the system 1 18 When moving the system 1 20 Operator Panel Movement Controls 1 21 Setting the front wheels lock 1 23 System Start Up Power On 1 24 Power Off 1 25 Circuit breaker 1 27 Probes Introduction 1 28 Connecting the Probe 1 29 Cable Handling 1 30 Activating the Probe 1 30 Disconnecting the Probe 1 31 Probe Discussion 1 31 Biopsy Special Concerns 1 41 Prepa...

Page 10: ...recautions 3 4 Probe Cleaning Process 3 5 Coupling gels 3 16 System Presets Foreign Language Keyboard Setup 3 18 Data Backup EZBackup and EZMove 3 25 Backup procedure user defined configurations 3 32 Restore procedure patient data 3 33 Restore procedure user defined configurations 3 34 Configuring Connectivity Overview 3 35 Connectivity Functions 3 36 Anti Virus Software Note 3 37 Electronic Docum...

Page 11: ...nts 4 2 Notice against user modification 4 3 Safety Precautions Precaution Levels 4 4 Hazard Symbols 4 5 Patient Safety 4 7 Equipment and Personnel Safety 4 11 Classifications 4 18 EMC Electromagnetic Compatibility 4 19 Patient Environmental Devices 4 31 Acoustic Output 4 33 Device Labels Label Icon Description 4 37 Warning Label Locations 4 43 Index ...

Page 12: ...i 10 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 ...

Page 13: ...LOGIQ E9 User Guide 1 1 Direction 5454884 100 English Rev 1 Chapter 1 Getting Started Console Overview Moving the System System Start up Probes and Beginning an Exam ...

Page 14: ...dures for operation and safety precautions Disregarding information on safety is considered abnormal use Not all features or products described in this document may be available or cleared for sale in all markets Please contact your local GE Healthcare Ultrasound representative to get the latest information NOTE Please note that orders are based on the individually agreed upon specifications and m...

Page 15: ...the user manual Clinical Applications Specific clinical applications and exam types include Fetal Obstetrics Abdominal includes renal GYN Pelvic Pediatric Small Organ breast testes thyroid Neonatal Cephalic Adult Cephalic Cardiac adult and pediatric Peripheral Vascular Musculo skeletal Conventional and Superficial Urology including prostate Transrectal Transvaginal Transesophageal Intraoperative a...

Page 16: ...ication The LOGIQ E9 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye Only qualified physicians or sonographers should perform ultrasound scanning on human subjects for medical diagnostic reasons Request training if needed ...

Page 17: ...ns around the equipment Ensure that the following is provided for the new system A separate power outlet with a 20 amp circuit breaker for 120 VAC for 120V area 7 5 amp circuit breaker for 220 240VAC for 220 240V area or 15 amp circuit breaker for 100 VAC for Japan Take precautions to ensure that the console is protected from electromagnetic interference Precautions include Operate the console at ...

Page 18: ...e 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 system is accidentally unplugged data may be lost CAUTION To avoid leakage current...

Page 19: ...be Holder 3 Operator Panel Probe Holders with Cable Management 4 Brake Release Up Down Controls 5 Peripherals Black White Printer CD DVD Drive V Nav option and Network Activity Speed Green 1 Gigabyte and Yellow 100 Mb and Hard Disk Drive Indicator 6 Probe Connectors 7 Brakes CAUTION For compatiblity reasons use only GE approved probes peripherals or accessories DO NOT connect any probes or accesso...

Page 20: ...rts 7 Patient I O ECG CW Probe Connector 8 Volume Navigation Connectors 9 Probe Connectors 10 Brake Pedal 11 Rear Handle 12 Power Cord Hook 13 Op Panel Up Down Manual Release Lever 14 Access to Peripheral USB Ports Audio In Out DVI Connector Ethernet Connectors S Video 15 Breaker Ground and Power Cord 16 Back Filter WARNING DO NOT touch the patient and any of the connectors on the ultrasound unit ...

Page 21: ...NLY BE USED for the following devices Color or Report Printer NOTE When connecting an external printer to the LOGIQ E9 via the USB port on the back of the system you MUST ensure that the power supplied to the printer is fed from the same power feed as the LOGIQ E9 This assures compliance to leakage currents Flash Drive Service Key CAUTION Peripheral devices that use their own AC power source canno...

Page 22: ...blity reasons use only GE approved probes peripherals or accessories DO NOT connect any probes or accessories without approval by GE CAUTION The connection of equipment or transmission networks other than as specified in these instructions can result in electric shock hazard Alternate connections will require verification of compatibility and conformity to IEC EN 60601 1 1 by the installer CAUTION...

Page 23: ...5454884 100 English Rev 1 Peripheral Accessory Connector Panel continued Figure 1 4 Peripheral Accessory Connector Panel Table 1 1 Peripheral Accessory Connector Panel Descriptions No Item Type of connector USB Ports USB 2 0 Ethernet RJ 45 Modular 8 pin ...

Page 24: ...4 100 English Rev 1 DVI Port Connector DVI Analog Video Output Note Use a DVI to VGA Adapter in order to connect an analog monitor Audio In Out ACR S Video S Video Table 1 1 Peripheral Accessory Connector Panel Descriptions Continued No Item Type of connector ...

Page 25: ...5 Control Panel 1 Probe and Cord Holder 2 USB Ports 2 3 Touch Panel and Joystick controls 4 Keyboard 5 Feature Keys 6 Mode Gain XYZ 3D Controls 7 TGC 8 Trackball Trackball Keys Pointer Measure Comment Body Pattern Clear Zoom 3D 4D P1 9 L R Start Stop Freeze 10 Steer Width Depth Reverse 11 Auto 12 P2 P3 P4 ...

Page 26: ...nding upon the currently displayed menu Press the button to switch between controls or rotate the dial to adjust the value or move the control left right or up down to adjust the value 1 Patient Enters Patient screen 2 Scan Enters scanning mode screen 3 Reports Activates default report and Touch Panel of report choices 4 End Exam Activates Image Management and Touch Panel with end of exam options ...

Page 27: ... User Guide 1 15 Direction 5454884 100 English Rev 1 Monitor Display Figure 1 7 Monitor Display Tour Figure 1 8 Monitor Display Tour 2 NOTE The date on the monitor may truncate the century when using the YYYY MM DD date format ...

Page 28: ...5 Imaging Parameters by Mode SoS indicator if applicable 16 Focal Zone Indicator 17 TGC 18 Depth Scale 19 Body Pattern 20 Cine Gauge 21 Current date and time Caps Lock lit when on network connection indicator PC connected PC with X not connected wireless LAN indicator WLAN connected WLAN with X not connected DVR status InSite ExC status InSite ExC controls system messages display 22 Image Manageme...

Page 29: ...st the brightness 1 Press the right adjustment button to increase brightness 2 Press the left adjustment button to decrease brightness The amount of brightness is shown on a slide bar on the screen Figure 1 9 Brightness adjustment button 1 Adjustment Button 2 Adjust Button Record any changes to the final brightness settings and leave this information with the system Generally speaking do not chang...

Page 30: ... are left on the console 5 Wind the power cable around the cable hook below the rear handle NOTE To prevent damage to the Power Cord DO NOT pull excessively on the cord or make sharp bends while wrapping 6 Connect all probes to be used while off site Ensure that probe cables are out of the way from the wheels and not protruding beyond the console Use the probe management hooks located below the Op...

Page 31: ...eir lowest positions by using the up down switch on the front of the operator panel Make sure the operator panel is locked in place 10 Unlock the wheels CAUTION DO NOT place probes into the front pocket storage area when moving the system This is not a storage space for probes CAUTION To prevent system damage while not in use AND OR before moving the system flip down the monitor and lock the monit...

Page 32: ...nsport NOTE Wheel chair ramps are usually less than five degrees 3 Use the foot brake pedal located on the bottom of the system in the front when necessary 4 Do not let the system strike walls or door frames 5 Use extra care when crossing door or elevator thresholds 6 Once the destination is reached lock the wheels CAUTION DO NOT attempt to move the console using any cables or fixtures such as the...

Page 33: ...rator Panel after moving Operator Panel sideways to the desired position release the left button After releasing the left button the system will lock into position after 3 seconds To raise lower the Operator Panel press and hold down the Up Down toggle button right button accordingly to raise or lower the Operator Panel Release the Up Down button when the Top Console is in the desired height To ma...

Page 34: ... are disabled The brakes are released XY movement is free but you cannot move the Operator Panel in the Z plane Park Lock Reset The Park Lock Reset control releases undocks the Operator Panel and resets the position of the Park Lock Park Lock Reset is located on the Utility System Peripherals screen under Miscellaneous Figure 1 11 Park Lock Reset After you press the Park Lock Reset control you can...

Page 35: ...the wheels in a forward to back position First move the system in the direction you will be going then press the Swivel Lock To release the Swivel Lock press the center brake release 3 2 Right Parking Brake Park To set the brake press the right pedal To release the brake press the center brake release 3 Center Brake Release Press the center brake to release the swivel lock parking brake 3 CAUTION ...

Page 36: ...gure 1 13 Operator Login Window 1 Operator Select the Operator 2 Password Enter Operator s password optional 3 Select type of Logon or Cancel Emergency Data stored only for the duration of the current examination OK Standard logon Cancel Cancel logon CAUTION Press the Power On Off switch to turn the power on The circuit breaker must also be in the on position For circuit breaker location see Circu...

Page 37: ...pears Select to end all system processes and shut down the system 4 Disconnect the probes Clean or disinfect all probes as necessary Store them in their shipping cases or another appropriate probe storage system to avoid damage NOTE When the Extended Power Supply EPS is installed battery replacement may be necessary if the circuit breaker is turned off for long periods of time 3 to 6 months Additi...

Page 38: ...s you that unsaved images are still in the system from the previous patient Respond to the prompt to continue the current patient Check that all images and measurements have been preserved in the system If you do not have any images on the clipboard the patient must be retrieved from the database Then resume the exam Unexpected Power Loss In case of unexpected power loss 1 Check the system On Off ...

Page 39: ...f a power overload If a power overload occurs 1 Turn off all peripheral devices 2 Reactivate the Circuit Breaker switch The Circuit Breaker switch should stay in the On position DO NOT hold the switch in the On position If the Circuit Breaker switch remains On follow the Power On procedure NOTE If the Circuit Breaker switch does not remain in the On position or trips again 1 Disconnect the Power C...

Page 40: ...e 1 15 4 DLP Probe Port Connectors DO NOT plug any LOGIQ 9 probes into the LOGIQ E9 system Use the left most probe port for the 3CRF S1 5 S4 10 and 6Tc probes use the 3 right probe ports for any ___ D probe Figure 1 16 1 Non DLP and 3 DLP Probe Port Connectors 1 3CRF S1 5 S4 10 and 6Tc Probe Connector 2 _____ D Probe Connector ...

Page 41: ...ed until functional and safe performance is verified A thorough inspection should be conducted during the cleaning process 4 Hold the probe connector vertically with the cable pointing upward 5 Align the connector with the probe port and carefully push into place Before inserting the 3CRF S1 5 S4 10 or 6Tc probe connector into the left most non DLP probe port see Figure 1 16 on page 1 28 inspect t...

Page 42: ...se the cable hooks located below the operator panel Do not bend the cable acutely Avoid crossing cables between probes Activating the Probe To activate the probe select the appropriate probe from the probe indicators on the Touch Panel Figure 1 17 Probe Indicators 1 Probe Indicators The probe s default settings for the mode and selected exam are used automatically ...

Page 43: ...e the cable is free 6 Be sure that the probe head is clean before placing the probe in its storage box or wall hanging unit 7 Probe Discussion The LOGIQ E9 supports the following types of probes Matrix Array Matrix Array probes Convex Array Convex Array probes Linear Array Linear Array probes Micro Convex Array Micro Convex Array probes Sector Phased Array Sector Phased Array probes Volume Probes ...

Page 44: ...dvanced 3D Raw Data PDI Scan Assistant Anatomical M Mode Retain Field of View Speed of Sound Image Quality Check Compare Assistant Biopsy capability Table 1 5 Active Matrix Array Probes Probe Indications for Use Capabilities and Features Illustration M6C D Abdomen OB GYN Pediatric CrossXBeam Anatomical Color M Table 1 6 Convex and Micro Convex Probes Probe Indications for Use Capabilities and Feat...

Page 45: ... Pediatric Coded Contrast Tru3D V Nav Elastography Elastography Quantification Not available in USA 3CRF Abdomen OB GYN Coded Contrast Tru3D V Nav CrossXBeam Anatomical Color M IC5 9 D OB GYN TV TR Urology Coded Contrast Tru3D V Nav CrossXBeam Anatomical Color M Elastography Elastography Quantification Not available in USA Table 1 6 Convex and Micro Convex Probes Continued Probe Indications for Us...

Page 46: ...inear Array Probes Probe Indications for Use Capabilities and Features Illustration 9L D Abdomen Musculoskeletal OB GYN Pediatric Peripheral Vascular Small Parts Coded Contrast Tru3D V Nav B Flow B Flow Color Elastography Elastography Quantification Not available in USA Biopsy capability 11L D Abdomen Musculoskeletal Peripheral Vascular Small Parts Biopsy capability ML6 15 D Musculoskeletal Neonat...

Page 47: ...le for all sector probes SRI HD LOGIQView Virtual Convex Raw Data PDI Scan Assistant Retain Field of View Speed of Sound Image Quality Check Compare Assistant Table 1 10 Sector Probes Probe Indications for Use Capabilities and Features Illustration M4S D Adult Cephalic Easy 3D Advanced 3D Anatomical M Mode Anatomical Color M M5S D Abdomen Adult Cephalic Cardiac OB GYN Pediatric Coded Contrast Easy...

Page 48: ...r M Biopsy capability S4 10 Cardiac Pediatric Neonatal Pediatric Coded Harmonics Easy 3D Advanced 3D Tru3D V Nav Anatomical M Mode CW Anatomical Color M Color M TVI TVD S4 10 D Cardiac Pediatric Neonatal Pediatric Coded Harmonics Easy 3D Advanced 3D Tru3D Anatomical M Mode Anatomical Color M Color M TVI TVD 6S D Cardiac Pediatric Coded Harmonics Easy 3D Advanced 3D Anatomical M Mode CW CAMM Anatom...

Page 49: ...ser Guide 1 37 Direction 5454884 100 English Rev 1 6Tc Cardiac Adult Transesophageal Anatomical M Mode CW CAMM Color M Table 1 10 Sector Probes Continued Probe Indications for Use Capabilities and Features Illustration ...

Page 50: ...ite guard when conducting a TEE examination When the message disappears and the calibration cycle is completed the probe is ready for operation In case the initialization of the probe fails no response from the scan plane buttons after initialization re select the probe to repeat the initialization routine Non Imaging CW Probes CAUTION Transesophageal probes require special handling Refer to the u...

Page 51: ...GIQ View 4D Raw Data PDI Scan Assistant Retain Field of View Speed of Sound Image Quality Check Compare Assistant Table 1 13 4D Probes Probe Indications for Use Capabilities and Features Illustration RNA5 9 D Neonatal Pediatric Anatomical M Mode Beta View Anatomical Color M CrossXBeam Biopsy capability RAB2 5 D Abdomen OB GYN Coded Contrast Anatomical M Mode Anatomical Color M CrossXBeam Biopsy ca...

Page 52: ...ress down on the Beta View control the probe head re centers itself Beta View is not available while the image is Frozen during an image Recall during a Biopsy procedure or during Volume Navigation When these controls are selected the Beta View Touch Panel control is hidden and unavailable RAB6 D Abdomen OB GYN Pediatric Coded Contrast Anatomical M Mode Anatomical Color M RIC5 9 D OB GYN TV TR Uro...

Page 53: ... mass during the procedure CAUTION The use of biopsy devices and accessories that have not been evaluated for use with this equipment may not be compatible and could result in injury CAUTION The invasive nature of biopsy procedures requires proper preparation and technique to control infection and disease transmission Equipment must be cleaned as appropriate for the procedure prior to use Follow t...

Page 54: ...tinued CAUTION Improper cleaning methods and the use of certain cleaning and disinfecting agents can cause damage to the plastic components that will degrade imaging performance or increase the risk of electric shock WARNING NEVER reuse the TR5 disposable biopsy guide attachment and Disposable sterile Ultra Pro II Needle guide kits ...

Page 55: ...lable biopsy options appear when Biopsy Kit is selected There are fixed and adjustable angle biopsy kits and plastic disposable and reusable biopsy guides available with the LOGIQ E9 depending on the probe Select the desired biopsy kit NOTE You can display the biopsy guideline on the CFM image in simultaneous mode Select the Show Biopsy Mark on CFM simultaneous Mode preset in the Utility System Sy...

Page 56: ...dezone represents a path of the needle The dots which make up the guidezones is the depth readout where Yellow represent 1 cm increments Red represents 5 cm increments The display should be carefully monitored during a biopsy for any needle deviation from the center line or guidezone Before scanning verify the needle can be visualized within the imaging plane User appropriate needle length to reac...

Page 57: ...asons Needle barrel to needle clearance or strength Bracket manufacturing tolerance Needle deflection due to tissue resistance Needle size chosen Thinner needles may deflect more DANGER Failure to match the guidezone displayed to the guide may cause the needle to track a path outside the zone It is extremely important that when using the adjustable angle biopsy guides the angle displayed on the sc...

Page 58: ...l sterile gel if necessary and disposable needle barrels The disposable needle barrels are available for a variety of needle sizes The bracket is packaged non sterile and is reusable To avoid possible patient contaimination ensure bracket is properly cleaned sterilized or disinfected before each use Disposable components are packaged sterile and are single use only Do not use if integrity of packi...

Page 59: ... probe orientation mark ridge Figure 1 20 Probe Bracket Alignment a Probe Orientation Mark b Bracket 3 Attach the biopsy bracket to the probe by sliding the bracket over the end of the probe until it clicks or locks in place 4 Place an adequate amount of coupling gel on the face of the probe WARNING DO NOT attempt to use the biopsy bracket and needle guide until the manufacturer s instructions pro...

Page 60: ...ssembly continued 5 Place the proper sanitary sheath over the probe and biopsy bracket Use the rubber bands supplied to hold the sheath in place Figure 1 21 Applying Sanitary Sheath 6 Snap the fixed or adjustable needle clip onto the biopsy guide bracket Figure 1 22 Fixed Needle Clip Attachment a Sheath a ...

Page 61: ...d to the bracket Figure 1 23 Locking the Needle Clip NOTE If using an in plane needle guide the needle clip appears as shown here Be sure to choose an in plane guide that matches the gauge of the needle being used The in plane guide does not support any on screen graphics This is because the guide allows variable angles For in plane needle guides steps 8 and 9 are not applicable Figure 1 24 Exampl...

Page 62: ...size needle barrel Twist it back and forth to remove it from the plastic tree Figure 1 25 Needle Barrel Selection 9 Place the needle barrel into the needle clip with the desired gauge facing the needle clip and snap into place Figure 1 26 Needle Barrel Installation CAUTION Ensure that all guide parts are seated properly prior to performing a biopsy ...

Page 63: ...ath Figure 1 27 Example 2 Pull up on the knob Figure 1 28 a to freely move the needle guide attachment Align the knob with the selected position of the needle guide attachment Push the knob down Figure 1 28 b into the desired slot to secure the angle position of the needle guide attachment Figure 1 28 Pull up and push down the knob WARNING DO NOT attempt to use the biopsy bracket and needle guide ...

Page 64: ...tinued 3 Fit a convex of the biopsy bracket a in a concave of the probe b Figure 1 29 Probe Bracket Alignment Hold the side a and tuck down the needle guide side b until it clicks or locks in place Figure 1 30 Probe Multi angle Bracket Alignment 2 4 Place an adequate amount of coupling gel on the face of the probe ...

Page 65: ...y Guide Assembly continued 5 Place the proper sanitary sheath tightly over the probe and biopsy bracket Use the rubber bands supplied to hold the sheath in place Figure 1 31 Applying Sanitary Sheath 6 Snap the needle guide onto the biopsy guide bracket Figure 1 32 Snap the needle guide ...

Page 66: ... lock a Make sure the needle guide is firmly attached to the bracket Figure 1 33 Lock the Needle guide 8 Choose the desired gauge size needle barrel Twist it back and forth to remove it from the plastic tree Figure 1 34 Needle Barrel 9 Place the needle barrel into the needle clip with the desired gauge facing the needle clip and snap into place Figure 1 35 Needle Barrel Installation ...

Page 67: ...glish Rev 1 Multi Angle Biopsy Guide Assembly continued Remove the biopsy guide 1 Hold the other side and push out the needle clip attachment side See Figure 1 36 Figure 1 36 Remove the biopsy guide CAUTION Prevent damage to the probe lens with finger nails ...

Page 68: ...cedure you remove the needle from a probe and an assembly without moving the needle Figure 1 37 Release the needle from assembly a Push the knob portion of a sleeve in the direction of the arrow b The needle is released from the assembly c Push the probe and the assembly in the direction of the larger arrow to remove the needle ...

Page 69: ...ut the attachment area on the probe head Figure 1 38 Attachment Filling Removal a Probe Head b Attachment c Filling Removal Tool 3 Clean then disinfect the probe NOTE Ensure that protective gloves are worn WARNING DO NOT use the needle with the catheter soft tube There is a possibility of breaking the catheter in the body CAUTION Before inserting the needle scan the patient to determine the correc...

Page 70: ...an adequate amount of ultrasound gel inside the sheath tip the gel is between the sheath inner surface and the probe aperture NOTE Ensure that only acoustic coupling gel is used for this purpose 3 Place the sheath tip over the probe aperture and then pull the sheath end toward the probe handle 4 Inspect the sheath for nicks cuts or tears Figure 1 39 Endocavitary Probe with Sheath a Probe Handle b ...

Page 71: ...robes use the TR5 guidelines for the plastic disposable only biopsy guides use the RU guidelines with the stainless steel reusable biopsy guides 2 Place an adequate amount of ultrasound gel on the gel filled sheath tip s outer surface 3 Ensure the guide is properly seated and secure by pushing forward on the needle insertion end of the guide until the attachment node is firmly in place in it s hol...

Page 72: ...n the housing of the probe 3 Fix the biopsy guide by locking the frame on the opposite side 4 Pull lightly and rotate the needle guide barrel to position with the needle hole on the front side NOTE Needle guide sterilization with autoclave possible 4D Endocavitary Probe 1 Press the needle guide onto the probe shaft and push it forward until the small swelling of the needle guide cacthes in the not...

Page 73: ...ct Biopsy kit The available biopsy options from the Touch Panel Select the biopsy guidezone where the needle echo passes through the center of the guidezone Use the selected biopsy guidezone when performing the biopsy Biopsy Needle Path Verification To verify that the path of the needle is accurately indicated within the guidezone on the system monitor perform the following Properly install the br...

Page 74: ...ngle guides ensure that the proper guidezone angle is displayed Figure 1 43 B Mode Touch Panel 3 Scan to locate the target Center the target in the electronic guidezone path NOTE Enabling color flow would allow for visualization of the vascular structure around the area to be biopsied 4 Place the needle in the guide between the needle barrel and needle clip Direct it into the area of interest for ...

Page 75: ...f these items in accordance with current facility guidelines Clean and disinfect the probe See Probe Cleaning Process on page 3 5 for more information The biopsy bracket can be cleaned and disinfected in a recommended disinfecting agent and reused CAUTION When the biopsy needle guide kit is opened all parts must be discarded after the procedure whether they have been used or not ...

Page 76: ... 1 46 for more information Sterile gel is applied to the transducer face and a sterile sheath completely covers the transducer and cable which has first undergone a thorough cleaning and high level disinfection The invasive nature of biopsy procedures requires proper preparation and technique to control infection and disease transmission Equipment must be cleaned as appropriate for the procedure p...

Page 77: ...of the probe 2 The scanner surgeon sonographer etc should be sterile and gloved 3 Place an adequate amount of sterile coupling gel on the face of the probe 4 Place the proper sterile sheath over the probe and cord Figure 1 44 Applying Sterile Sheath 5 Depending on the type of procedure use either sterile water or sterile gel on the sheath cover NOTE Follow your institutions guidelines on post surg...

Page 78: ...ient is registered to No Archive If the Warn register to No Archive preset is selected in the Utility Connectivity Miscellaneous menu a warning displays A different dataflow for permanent storage of patient data should be selected 6 Fill in patient information NOTE You can also select a patient from the patient database at the bottom of the Patient menu if the patient has a patient ID Columns driv...

Page 79: ...matically from the scan screen when you select OK from the ID is not unique warning message HINTS When you press a Print key during scan Live Store the LOGIQ E9 stores the cine for the specified length of time noted in the Time Span s preset found under Time Based Store in Utility Application Print Controls When you press a Print key during scan Live Store with ECG the LOGIQ E9 stores the cine for...

Page 80: ...sh Rev 1 Patient Screen Figure 1 45 Patient Screen Example Category OB 1 Image Management 2 Function Selection 3 EZBackup EZMove 4 Dataflow Selection 5 Exit 6 Patient Information 7 Category Selection 8 Exam Information 9 Scan Assistant Program 10 Patient View Exam View ...

Page 81: ...des an interface to handle patient data from a remote device Function Selection New Patient Used to clear patient entry screen in order to input a new patient s data into the database Register Used to enter new patient information into the database prior to the exam NOTE If you are using the auto generate Patient ID feature do not select Register It is always a good practice to Register all patien...

Page 82: ...lection Select the appropriate dataflow NOTE If you use a DVD R select DICOM CD Read in Dataflow If you place the cursor on the icon the pop up menu displays disk capacity Figure 1 46 Dataflow Pop up Exit Used to exit the Patient Menu WARNING Ensure you have selected a dataflow If No Archive is selected no patient data is saved A Ø appears next to Dataflow if No Archive is selected ...

Page 83: ...irthdate Age automatically calculated when birthdate is input Sex Category Selection Select from 8 exam application categories Abdomen Obstetrics Gynecology Cardiology Vascular Urology Small Parts or Pediatrics When a category is selected the measurement and category presets are displayed Exam Information Shows the Current Active Exam information Information pertinent to the selected exam category...

Page 84: ...ivity Miscellaneous Double click on patient list to start preset Search key select search item from Patient ID Last Name First Name Other ID Birthdate Sex Exam Date Exam Today Accesstion Number Exam Description Exam Date Before Exam Date Between Exam Date After Locked Y N or Img Archived Y N NOTE If Exam Date Between is selected the Input Dialog displays and you can select the date from the displa...

Page 85: ...m for that patient if you select the last exam of the day New Exam Creates a new exam based on a current or searched patient Delete Deletes Patient Exam NOTE Delete is only displayed when you login as Administrator Lock Unlock Locks the exam patient Prevents move and delete functions Exam View Displays the Exam History of the selected patient by date Disk Displays the disk name on which you saved ...

Page 86: ... image data with the EZMove function does not reduce the patient number in the database NOTE Ensure that all patients are exported or backed up BEFORE deleting them We recommend attaching the patient list to the EZBackup media Insert the media and select DICOM CD Read for the dataflow if you use a USB drive select DICOM USB Drive Read Press the right Set key to select the patient Press the left Se...

Page 87: ...LOGIQ E9 User Guide 2 1 Direction 5454884 100 English Rev 1 Chapter 2 Performing an Exam Optimizing the Image and Measurement and Analysis ...

Page 88: ...one s so that you can tighten up the beam for a specific area A graphic caret corresponding to the focal zone position s appears on the right edge of the image Auto Optimize No Auto Optimize Auto lets you optimize the image based upon a the actual B Mode image data Auto Tissue Optimize ATO The preset levels Low Medium and High allow you to pick a preference for the contrast enhancement in the resu...

Page 89: ...ing bi cubic interpolation Coded Harmonic Imaging CHI Yes Harmonic imaging utilizes Digitally Encoded Ultrasound DEU Coded Harmonics enhances near field resolution for improved small parts imaging as well as far field penetration Frequency Yes Multi Frequency mode lets you downshift to the probe s next lower frequency or shift up to a higher frequency Steer Yes You can slant the B Mode or Color Fl...

Page 90: ...e realtime or CINE images or Timeline CINE but not DVR images Colorizes the gray scale image to enhance the eye s discrimination capability Spectrum Colorize colorizes the spectrum as a function of power using the inverse of the Colorize map for the signal intensity in each Doppler line Colorize enhances the visibility of the spectrum s characteristics and enhances your ability to identify spectra...

Page 91: ...locities and blue toward positive velocities You can invert a real time or frozen image NOTE Invert reverses the color map NOT the color Scale Baseline No Changes the Color Flow or Doppler spectrum baseline to accommodate higher velocity blood flow Minimizes aliasing by displaying a greater range of forward flow with respect to reverse flow or vice versa Baseline adjusts the alias point The defaul...

Page 92: ...p lightens The effect is visible in the color bar CF PDI Vertical Size No You can set the default CF PDI ROI vertical size CF PDI Width No You can set the default CF PDI ROI width CF PDI Center Depth No You can set the default CF PDI center depth CF PDI Frequency MHz No You can set the default CF PDI Frequency MHz CF PDI Auto Frequency No You can set the default CF PDI Auto Frequency CF PDI Focus ...

Page 93: ... Speed Yes Changes the speed at which the timeline is swept Available in M Mode Doppler Mode and M Color Flow Mode Anatomical M Mode Yes Anatomical M Mode gives you the ability to manipulate the cursor at different angles and positions The M Mode display changes according to a motion of the M cursor Curved Anatomical M Mode CAMM displays a distance time plot from a free drawn cursor line CAMM is a...

Page 94: ... to be measured NOTE When the Doppler Mode Cursor and angle correct indicator are aligned the angle is O you cannot see the angle correct indicator Quick Angle No Quickly adjusts the angle by 60 degrees Wall Filter No Insulates the Doppler signal from excessive noise caused from vessel movement Baseline No Adjusts the baseline to accommodate faster or slower blood flows to eliminate aliasing Mode ...

Page 95: ...play Format No Changes the horizontal vertical layout between B Mode and M Mode or timeline only Modify Auto Calcs No Activates the menu to select which calculations are automatically calculated Auto Calcs No Activates the calculation automatically which you select in the Modify Auto Calculation when the system is in a state of freeze or live Table 2 4 Doppler Mode Controls Continued Control Possi...

Page 96: ... on the right side of the screen NOTE If the image stops before you re done scanning start acquiring the 3D volume of interest again 6 To complete the 3D scan press End Trackball key NOTE You can also press Freeze but then you need to also press the 3D key to obtain the final render Table 2 5 3D Package Options 3D Type Description Sensor No Sensor Available Tabs Easy 3D Designed for rendering B Mo...

Page 97: ...play To activate new functionality for the Trackball press the correct key adjacent to the Trackball as indicated on the display Zoom Write zooming an image changes the frame rate which tends to change thermal indices The position of the focal zones may also change which may cause the peak intensity to occur at a different location in the acoustic field As a result the MI TI may change To zoom an ...

Page 98: ...r spline trace on both the left and right image at the same time Whichever side of the screen that you annotate is called the Original graphic The copy is called the Shadow graphic Freezing an image To freeze an image 1 Press Freeze The Freeze key backlight turns green If you are in a mixed mode both screen formats stop immediately Deactivating Freeze restarts both modes and places a black bar on ...

Page 99: ...et controls A probe mark is associated with the body patterns and illustrates the probe position on the body pattern This marker can be placed with the Trackball and rotated with the Ellipse control The probe mark type is selectable by rotating the Probe Type control on the Touch Panel There are different choices available with one being a blank selection To select the active side in dual B Mode u...

Page 100: ...ackball to move the cursor To delete comments by character press the Backspace key To delete all comments and arrow marks press the Clear key twice immediately after entering the comment mode To move by words or by text group press the Tab key Arrow pointers can be used by activating the F2 Arrow key on the keyboard or by selecting the Comment key and then the top Trackball key When the pointer co...

Page 101: ... to Manage Images You can manage images from the display via these on display controls Figure 2 1 Menu Icons 1 Active Images Screen 2 Delete Image 3 Next Previous Image s and Clipboard Slide Show if you press and hold down the Ctrl key Next or Previous Arrow 4 Save As Menu 5 Thumbnail Size 6 Number of Images in Exam ...

Page 102: ...abases used within the system software that are associated with specific investigators are so noted Be sure to refer to the original article describing the investigator s recommended clinical procedures WARNING The system provides calculations e g estimated fetal weight and charts based on published scientific literature The selection of the appropriate chart and clinical interpretation of calcula...

Page 103: ...lear button 3 Ellipse After the first caliper for a distance measurement has been set and the second caliper positioned Ellipse activates the area ellipse measurement function During the ellipse adjustment use the Trackball to increase or decrease the size of the ellipse Select Cursor Select to adjust the measurement calipers 4 Trackball Moves the measurement calipers selects the measurement on th...

Page 104: ...lish Rev 1 B Mode Measurements Two basic measurements can be made in B Mode Distance Circumference and Area Ellipse Method Trace Method Spline Method Intensity Echo level Method NOTE The following instructions assume that you first scan the patient and then press Freeze ...

Page 105: ...line connects the measurement points if preset accordingly 5 To complete the measurement press Set The system displays the distance value in the Results Window The following hints can help you to perform distance measurements HINTS Before you complete a measurement To toggle between active calipers press the top Trackball key To erase the second caliper and the current data measured and start the ...

Page 106: ...ial circle shape displays 6 To position the ellipse and to size the measured axes move the calipers move the Trackball 7 To increase the size adjust the Ellipse control in a clockwise direction To decrease the size adjust the Ellipse control in a counterclockwise direction 8 To toggle between active calipers press the top Trackball key 9 To complete the measurement press Set The system displays th...

Page 107: ...2 Press the top Trackball key to select Trace a caliper displays 3 To position the caliper at the start point move the Trackball 4 To fix the trace start point press Set The caliper changes to an active caliper 5 To trace the measurement area move the Trackball around the anatomy A dotted line shows the traced area 6 To complete the measurement press Set The system displays the circumference and t...

Page 108: ...ace start point press Set The caliper changes to an active caliper 5 To trace the measurement area move the Trackball around the anatomy A dotted line shows the traced area 6 To complete the measurement press Set The system displays the circumference and the length in the Results Window HINTS Before you complete the trace measurement To erase the line bit by bit back from its current point move th...

Page 109: ...e Spline trace is cancelled 5 To position the second caliper move the Trackball and press Set The third caliper appears at the same position NOTE The Clear key functionality is the same as noted in the previous step The spline trace requires at least three points to draw the trace Continue setting the points of the trace until the desired points are set 6 Press Set again after the last caliper is ...

Page 110: ...ts including the pick caliper are removed If the previous next fixed caliper exists on the image it is activated NOTE Pressing Clear at this time removes all points and the trace graphic 2 Move the pick caliper to the desired point and press Set The point is activated and turns green 3 Move the point to the desired position and press Set The point is fixed and turns yellow The pick caliper appears...

Page 111: ...point press Set The caliper changes to an active caliper 5 To trace the measurement area move the Trackball around the anatomy A dotted line shows the traced area 6 To complete the measurement press Set The system displays the echo level as EL __ dB in the Results Window NOTE The echo level measurement is only available on a frozen image not on a B paused image NOTE Echo Level is not available thr...

Page 112: ...ume Flow NOTE The following instructions assume that you do the following 1 In the B Mode part of the display scan the anatomy you want to measure 2 Go to the Doppler Mode part of the display 3 Press Freeze Velocity To measure velocity 1 Press Measure an active caliper with a vertical dotted line displays 2 To position the caliper at the desired measurement point move the Trackball 3 To complete t...

Page 113: ...pends upon the Vol Flow Method preset The two selections available are Peak TAMAX and Mean TAMEAN To auto trace TAMAX 1 Press Measure Press the top Trackball key to select Trace an active caliper with a vertical dotted line displays Select Auto on the Touch Panel 2 To position the caliper at the trace start point in the Doppler spectrum move the Trackball 3 To fix the start point press Set 4 To po...

Page 114: ...he end point move the Trackball 5 To complete the measurement press Set The system displays the two peak end point velocities the time interval and the acceleration in the Results Window Time interval To measure a horizontal time interval 1 Press Measure Press the top Trackball key to select Time an active caliper with vertical and horizontal dotted lines displays 2 To position the active caliper ...

Page 115: ...ue depth measurement in M Mode functions the same as distance measurement in B Mode It measures the vertical distance between calipers 1 Press Measure once an active caliper with a vertical and horizontal dotted line displays 2 To position the active caliper at the most anterior point you want to measure move the Trackball 3 To fix the start point press Set The system fixes the first caliper and d...

Page 116: ...ckball 5 To complete the measurement press Set The system displays the time interval between the two calipers in the Results Window Slope Time interval and Velocity To measure time and velocity between two points 1 Press Measure Press the top Trackball key to select Slope an active caliper with vertical and horizontal dotted lines displays 2 To position the active caliper at the start point move t...

Page 117: ...m crashes As you complete measurements the system puts measurement data in the appropriate worksheets To view a worksheet To view a worksheet select Worksheet on the Touch Panel The system displays the worksheet for the current study Figure 2 4 OB B Mode Worksheet To return to scanning do one of the following Select Worksheet Press Esc Select the Exit button ...

Page 118: ...worksheet Figure 2 5 Worksheet Display Touch Panel To view worksheet data for a particular mode select the key for that mode To view a worksheet with data for more than one mode select Expand When Expand is selected it defaults to view all measurements noted by mode on the worksheet If a worksheet has more data on a second page to view the next page adjust the Page Change control ...

Page 119: ...on a worksheet 1 To position the cursor at the field you want to delete or exclude move the Trackball The field is highlighted 2 Do one of the following To delete the field select Delete Value To exclude the field select Exclude Value The data in the field is not visible and is not included in worksheet calculations To include a value that you previously excluded select Exclude Value To type a com...

Page 120: ...value off Select the method type Off The value field becomes blank Figure 2 6 Volume Parameter Off HINTS Some fields on the worksheet are view only and others you can change or select To easily see which fields you can change or select move the Trackball As the cursor moves over a field that you can change or select the field is highlighted ...

Page 121: ... Delete All Worksheet Values You can delete all worksheet values on a worksheet 1 When the Worksheet is displayed on the monitor press the Clear key the following warning message appears Figure 2 7 Delete All Warning Message 2 Select OK to delete all Select Cancel to cancel the deletion ...

Page 122: ...ble equipment malfunctions that could affect measurement accuracy a quality assurance QA plan should be established for the equipment that includes routine accuracy checks with tissue mimicking phantoms Please be advised that all distance and Doppler related measurements through tissue are dependent upon the propagation velocity of sound within the tissue The propagation velocity usually varies wi...

Page 123: ...ater All probes Not Equal To 1540m s Circumference Trace Equal to 1540m s mm Full Screen 5 or 1mm whichever is greater Ellipse Equal to 1540m s mm Full Screen 5 or 1mm whichever is greater Trace Not Equal to 1540m s mm Full Screen 7 5 or 5mm whichever is greater All probes Not Equal To 1540m s Ellipse Not Equal to 1540m s mm Full Screen 7 5 or 5mm whichever is greater All probes Not Equal To 1540m...

Page 124: ...ler Sample Volume Depth SVD mm Full Screen 2mm 0 2cm in any direction When SVD is at least half the depth of the image Velocity cm s Full Range 10 PW and CW Doppler Mode Doppler Angle Correction degrees From 0 59 From 60 90 1 2 Table 2 6 System Measurements and Accuracies Continued Measurement Units Useful Range Accuracy Limitations or Conditions ...

Page 125: ... Environment CAUTION DO NOT place an off line paper printer inside the patient environment within the dotted line area noted by 1 in Figure 2 8 Refer to the off board printer s manual for details Peripheral devices that use their own AC power source CANNOT be connected to the LOGIQ E9 DO NOT connect the peripheral device s power cord into the LOGIQ E9 system CAUTION Use a USB printer cable that is...

Page 126: ...Performing an Exam 2 40 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 ...

Page 127: ...tion 5454884 100 English Rev 1 Chapter 3 After the Exam is Over Probe Overview System Presets DataBackup Configuring Connectivity Electronic Documentation Contact Information System Data System Care and Maintenance and Accessories ...

Page 128: ...5454884 100 English Rev 1 Probe Overview Probe Naming Conventions Table 3 1 Probe Naming Convention Real Time 4D Type Application Frequency Connector Type R C Convex L Linear M Matrix S Sector AB Abdominal IC Intracavitary NA Neonatal SP Small Parts 1 5 D DLP ...

Page 129: ...t be reused between patients It is very important therefore to minimize the risk of disease transmission by using barriers and through proper processing between patients CAUTION Risk of Infection ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of examination and use FDA cleared probe sheaths where appropriate CAUTION Adequate cleaning and disinfection ar...

Page 130: ...OT allow the sterilant to contact the patient Only immerse the probe to its specified level Ensure that no solution has entered the probe s handle before scanning the patient If sterilant comes into contact with the patient refer the the sterilant s instruction manual Sterilant Exposure from Probe Connector to Patient e g Cidex DO NOT allow the sterilant to contact the patient Only immerse the pro...

Page 131: ... as needed using a soft sponge gauze or cloth to remove all visible residue from the probe surface Prolonged soaking or scrubbing with a soft bristle brush such as a toothbrush may be necessary if material has dried onto the probe surface 3 Rinse the probe with enough clean potable water to remove all visible soap residue 4 Air dry or dry with a soft cloth CAUTION Take extra care when handling the...

Page 132: ...After the Exam is Over 3 6 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 Cleaning probes continued Figure 3 1 Probe Immersion Levels 1 Fluid Level ...

Page 133: ...e label CAUTION Dangerous voltage the lightning flash with arrowhead is used to indicate electric shock hazards Biohazard Patient user infection due to contaminated equipment Usage Cleaning and care instructions Sheath and glove guidelines Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling Use care when handling and protect from damage when n...

Page 134: ...P6 16 D 6S D 6Tc P2D P6D Anios X X Aniosyme DD1 X Anioxyde 1000 X Asepti Wipes X X X Asepti Wipes II X X X X X X X X X Cavi Wipes X X X X X X X X X Cidex X X X X X X X X X X X X X X X X X X X Cidex OPA X X X X X X X X X X X X X X X X X X X X X Cidex Plus X X X X X X X X X X X X X X X X X Cidezymel Enzol X X X Cleanisept wipes X X X X X X X X X X X X X X X DisOPA X Gigasept X X X X Gigasept AF X X ...

Page 135: ...loth Germicidal X X X Sani Cloth HB X X X X X X X X X X X X X X X X X X X X Sekusept Aktiv X Sekusept Plus X Septiwipes X X X X X X X X X X X X X X X Sporox X X Sporox II X X X X Ster Bac Blu X X X X X X X Super Sani Cloth X X TD 100 and TD 5 X Transeptic Spray X X X X X X X X X Tristel Generator Solution X X X X T Spray X X X X X X X X X X X X X X X X X X X Table 3 3 Probe Disinfectants Continued...

Page 136: ...X X X X X Trophon EPR X X X X X X X X X Wavicide 01 X X X X X X X X X X X X X X X X X X X X X Table 3 3 Probe Disinfectants Continued Disinfectant 9L D 11L D ML6 15 D L8 18i D M4S D M5S D S1 5 S1 5 D S4 10 S4 10 D C1 5 D C1 6 D C2 9 D M6C D 3CRF IC5 9 D RNA5 9 D RAB2 5 D RAB4 8 D RAB6 D RIC5 9 D RSP6 16 D 6S D 6Tc P2D P6D ...

Page 137: ...m the probe and allow to air dry CAUTION In order for liquid chemical germicides to be effective all visible residue must be removed during the cleaning process Thoroughly clean the probe as described earlier before attempting disinfection You MUST disconnect the probe from the LOGIQ E9 prior to cleaning disinfecting the probe Failure to do so could damage the system DO NOT soak probes in liquid c...

Page 138: ... probe into any liquid beyond the level specified for that probe Never immerse the transducer connector or probe adapters into any liquid Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the cable Transducer damage can result from contact with inappropriate coupling or cleaning agents Do not soak or saturate transducers with solutions contai...

Page 139: ...igure 3 2 Trophon EPR 1 Screen Display 2 Start Button 3 Soft key buttons 1 Chamber door handle 2 Probe cable clamp 3 Cartridge door CAUTION Only those individuals previously trained on the Trophon EPR unit may use the device Refer to the Trophon EPR user documentation for more information on disinfecting approved probes ...

Page 140: ... Do not use excessive force to accomplish this The door clicks into place and locks Disinfecting probe in Trophon EPR 8 When the screen message reads Load Probe open the chamber door 9 Clean and rinse the probe Dry the probe NOTE The probe must be cleaned per the manufacturer s guidelines and dried before disinfection 10 Place Chemical Indicator on the bottom of the device chamber 11 While holding...

Page 141: ...es 15 Press Start to begin the disinfecting process 16 Discard disposable gloves Removing the Probe after 7 minute cycle time 1 Wear a new pair of disposable gloves 2 When Cycle complete displays on the screen open the chamber door 3 Check the Chemical Indicator color change and refer to the Chemical Indicator 4 Remove the Chemical Indicator from device and discard 5 Remove the probe from the Trop...

Page 142: ... Gel 9L D 11L D ML6 15 D L8 18i D M4S D M5S D S1 5 S1 5 D S4 10 S4 10 D C1 5 D C1 6 D C2 9 D M6C D 3CRF IC5 9 D RNA5 9 D RAB2 5 D RAB4 8 D RAB6 D RIC5 9 D RSP6 16 D 6S D 6Tc P2D P6D Aquasonics 100 X X X X X X X X X X X X X X X X X X X X Clear Image X X X X X X X X X GE Ultrasound Contact Gel X X X X X X HAIYIN Gel X X X X X X X X X Incidin Foam X Kendall X X X X X X X X X Natural Image X X Scan X ...

Page 143: ...l Iodine Lotions Lanolin Aloe Vera Olive Oil Methyl or Ethyl Parabens para hydroxybenzoic acid Dimethylsilicone Polyether glycol based Petroleum Sterile Ultrasound Procedures ONLY ultrasound gel that is labeled as sterile is sterile Ensure you always use sterile ultrasound gel for those procedures that require sterile ultrasound gel Once a container of sterile ultrasound gel is opened it is no lon...

Page 144: ... system Typing Foreign Characters on the International Keyboard To type foreign characters press Alt Shift to change the keyboard to the international keyboard then press the Alt GR appropriate keyboard key AltGr Q to type ä AltGr W to type å AltGr E to type é AltGr Y to type ü AltGr I to type í AltGr P to type ö AltGr A to type á AltGr Function Key to type ç Shift 6 a to type â Shift 6 e to type ...

Page 145: ...anges on each setup page before moving to the next page 1 In Utility System General set the Language as Russian or Greek Save this setting but do not reboot the system yet Figure 3 3 Changing the System Language to Russian Greek 2 Press Regional Options The Region and Language pop up menu appears Under Format select Russian Russia Greek Greece press Apply Press OK Figure 3 4 Region and Language ...

Page 146: ...ards and Languages tab Select the Change Keyboards button The Text Services and Input Languages pop up appears On the General Tab under Default input language select Russian Russia Russian Greek Greece Greek In the Installed Services section ensure that both English United States and Russian Russia both appear Press Apply Press OK Figure 3 5 Set Language ...

Page 147: ...nglish Rev 1 Keyboard Setup for Russian Greek Languages continued 4 Under Choose a display language select Russian Greek Press Apply Figure 3 6 Set Language 5 The Change Display Language pop up prompt appears Press Cancel Press OK Figure 3 7 Change Display Language ...

Page 148: ...nguages continued 6 Select the Administrative tab In the Language for non Unicode programs section select the Change system locale button The Region and Language Settings pop up menu appears Figure 3 8 Change system locale 7 Under Current system locale select Russian Russia Greek Greece Press OK Figure 3 9 Set Language ...

Page 149: ...se The Change System Locale pop up prompt appears again Press Cancel again Press Exit Figure 3 10 Change system locale 9 Reboot the system When your system restarts the system appears in the selected language NOTE To have the settings take effect you MUST turn off the system and turn it back on NOTE Service password does not work for Greek and Russian language settings Change the setting to Englis...

Page 150: ...User Guide Direction 5454884 100 English Rev 1 Keyboard Setup for Russian Greek Languages continued Here is an example of the Russian keyboard Figure 3 11 Russian Keyboard Here is an example of the Greek keyboard Figure 3 12 Greek Keyboard ...

Page 151: ... a log and by creating a media filing system For example if you need to back up 500 MB day or 2 5 GB week then you need to back up 5 CDs week or 250CDs year Generally speaking you should back up the system when you have 10 GB of images to back up You should assign the person who is in charge of performing the backups Backups will vary by the volume of your work You need to track how long it takes ...

Page 152: ...he patient database Patient Archive and Report Archive If for any reason the Local Archive Int HD gets corrupted or the base system software has to be reloaded then the patient archive is the ONLY way to rebuild the EZBackup and EZMove patient archive CAUTION After copying the image file to the media EZMove deletes the image file from the Local HD EZBackup does not back up the exams which were pre...

Page 153: ...dure go to the Patient menu and select EZBackup EZMove The EZBackup EZMove Wizard starts NOTE EZBackup EZMove can take up to 20 minutes or longer depending on the size of the backup Make sure to schedule this at the same time daily when no patients are scheduled 4 Verify the information on the first page of the EZBackup EZMove Wizard then press Next Full backup options display on the first page of...

Page 154: ...s per media NOTE The calculation for the number of backup CDs is only an estimate Allow for one additional CD when performing an EZBackup EZMove NOTE If you use the USB HDD some wizards and the pop up messages DO NOT appear 5 Verify the information on the EZBackup EZMove Wizard Page 2 The backup may span multiple media This page tells you how many media you need to do this backup After you have ga...

Page 155: ...of the media c After the backup move has been completed file the media NOTE You can cancel the backup move at any time The system completes backing up the current media and then cancels the operation NOTE If the system locks up during the media auto format process shutdown the system by holding down the power button and boot it up again After the system is up replace the media to a new one and exe...

Page 156: ...ges We recommend attaching the patient list to the EZBackup EZMove media Insert the media and select DICOM CD Read from the Patient Screen for dataflow if you use a USB drive select DICOM USB Drive Read Select any patient and press the left Set key to print the patient list on the digital printer for each CD DVD CAUTION NEVER restore the patient archive from media made previous to the last move Yo...

Page 157: ... indicated on the Patient Menu 3 View the exam from the media NOTE You may need to insert a media volume prior to or after the recommended media NOTE If the patient is split over multiple media images on the previous or next media are displayed as triangles NOTE To view the whole patient on the system use Import from as many media as you have for that patient However take care not to import studie...

Page 158: ... If you are not logged in with administrator privileges the Operator Login window is displayed Log on with administrator privileges 5 In the Backup list select User Defined Configuration 6 In the Media field select a media 7 Select Backup The system performs the backup As it proceeds status information is displayed on the Backup Restore screen 8 After the backup is complete press F3 to eject the C...

Page 159: ...t logged in with administrator privileges the Operator Login window is displayed Log on with administrator privileges 5 In the Restore list select Patient Archive 6 In the Media field select the media 7 Select Restore The system performs the restore As it proceeds status information is displayed on the Backup Restore screen CAUTION The restore procedure overwrites the existing database on the loca...

Page 160: ...th administrator privileges 5 In the Restore list select from the following depending on which configurations you want to restore User Defined Configuration OR Select the parameters to be restored in the Detailed Restore section 6 In the Media field select the media 7 Select Restore The system performs the restore As it proceeds status information is displayed on the System Backup Restore screen C...

Page 161: ... 1 Configuring Connectivity Overview You use Connectivity functionality to set up the connection and communication protocols for the ultrasound system The following page gives an overview of each of the Connectivity functions Each function is described in detail in the following pages ...

Page 162: ... the ultrasound system to work according to the services associated with the selected dataflow 5 Button allows you to assign a pre configured output service or a set of output services to the Print keys on the control panel 6 Removable Media enables formatting DICOM database or blank formatting and DICOM verification of removable media 7 Miscellaneous allows you to set up the patient exam menu opt...

Page 163: ...hich was used by the MSBlast virus are disabled Ports remaining opened are Port 104 is used for DICOM communication only 2 All operating system services that are not used by the system application software such as DCOM Windows Messenger Service and UPnP are disabled to help ensure that the source of security vulnerabilities is minimized 3 The operating system is locked down to prevent a user from ...

Page 164: ...are The main reasons for not doing so Every Virus scanner is constantly active in the background Due to the software intensive operating system of the Ultrasound scanner all computing resources are required for normal operation of this device Anti Virus software activities would have a negative impact on the system performance The operating software of a medical Ultrasound system is part of an FDA...

Page 165: ...dia into the media drive 2 Open the media drive on your desktop 3 Double click on the gedocumentation html document 4 Select the item you want to view click on the blue underlined link in the File Name column To close the window click on the X in the upper right hand corner of the browser window NOTE If your PC does not have Adobe Reader a free download is available on the Adobe website at http ww...

Page 166: ...g password uls Press Okay 3 Select Utilities 4 Insert the media 5 Select Common Utilities 6 Select Scanner Documentation Interface 7 Scroll to find the document and double click on it to open it NOTE You can search through a document use hyperlinks in the Table of Contents and Index to locate topics and navigate via bookmarks NOTE In addition to viewing documentation on the Ultrasound system the D...

Page 167: ... three sections navigational tools on the top left portion of the screen Hide Back Forward help book navigational tools on the left portion of the screen Contents Index Search Favorites and the content portion on the right side of the screen where help topics are displayed Figure 3 14 Opening Help Screen Exiting Online Help To exit Online Help press the X in the upper right hand corner of the Onli...

Page 168: ...enter TEL 1 800 682 5327 or 1 262 524 5698 In other locations contact your local Applications Sales or Service Representative Service Questions For service in the United States call GE CARES TEL 1 800 437 1171 In other locations contact your local Service Representative Information Requests To request technical product information in the United States call GE Healthcare TEL 1 800 643 6439 In other...

Page 169: ...L 3067 8010 FAX 011 3067 8280 CANADA GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa WI 53226 TEL 1 800 668 0732 Customer Answer Center TEL 1 262 524 5698 LATIN SOUTH AMERICA GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa WI 53226 TEL 1 262 524 5300 Customer Answer Center TEL 1 262 524 5698 MEXICO GE Sistemas Medicos de Mexico S A de C V R...

Page 170: ...2 229 CHINA GE Healthcare Asia No 1 Yongchang North Road Beijing Economic Technology Development Area Beijing 100176 China TEL 8610 5806 8888 FAX 8610 6787 1162 INDIA Wipro GE Healthcare Pvt Ltd No 4 Kadugodi Industrial Area Bangalore 560067 TEL 91 1 800 425 8025 KOREA 8F POBA Gangnam Tower 343 Hakdong ro Gangnam gu Seoul 135 820 Korea TEL 82 2 6201 3114 NEW ZEALAND 8 Tangihua Street Auckland 1010...

Page 171: ...2 0 FAX 43 1 97272 2222 BELGIUM LUXEMBURG GE Medical Systems Ultrasound Eagle Building Kouterveldstraat 20 1831 DIEGEM TEL 32 2 719 7204 FAX 32 2 719 7205 CZECH REPUBLIC GE Medical Systems Ultrasound Vyskocilova 1422 1a 140 28 Praha DENMARK GE Medical Systems Ultrasound Park Alle 295 2605 Brøndby TEL 45 43 295 400 FAX 45 43 295 399 ESTONIA FINLAND GE Medical Systems Kuortaneenkatu 2 000510 Helsink...

Page 172: ...ivision Akron u 2 Budaors 2040 Hungary TEL 36 23 410 314 FAX 36 23 410 390 IRELAND NORTHERN IRELAND GE Healthcare Victoria Business Park 9 Westbank Road Belfast BT3 9JL TEL 44 28 90229900 REPUBLIC OF IRELAND GE Healthcare Unit F4 Centrepoint Business Park Oak Drive Dublin 22 TEL 353 1 4605500 ITALY GE Medical Systems Italia spa Via Galeno 36 20126 Milano TEL 39 02 2600 1111 FAX 39 02 2600 1599 LUX...

Page 173: ... o o ul Woloska 9 02 583 Warszawa Poland TEL 48 22 330 83 00 FAX 48 22 330 83 83 PORTUGAL General Electric Portuguesa SA Avenida do Forte n 4 Fraccao F 2795 502 Carnaxide TEL 351 21 425 1309 FAX 351 21 425 1343 RUSSIA GE Healthcare Krasnopresnenskaya nab 18 bld A 10th floor 123317 Moscow Russia TEL 7 4957 396931 FAX 7 4957 396932 SPAIN GE Healthcare Espana C Gobelas 35 37 28023 Madrid TEL 34 91 66...

Page 174: ...12 284 67 00 Ankara Office Mustafa Kemal Mah 2158 Sok No 9 Çankaya Ankara TEL 90 312 289 77 00 FAX 90 312 289 78 02 UNITED ARAB EMIRATES UAE GE Healthcare Dubai Internet City Building No 18 P O Box 11549 Dubai U A E TEL 971 4 429 6101 or 4 429 6161 FAX 971 4 429 6201 UNITED KINGDOM GE Medical Systems Ultrasound TEL 44 1707 263570 71 Great North Road FAX 44 1707 260065 Hatfield Hertfordshire AL9 5E...

Page 175: ...A with on board peripherals Console Design 4 Active Probe Ports Probe connection area designed to allow free movement of legs KBD Monitor up down mechanism 200mm adjustable in height On board storage for peripherals Black white printer Rear Storage Cover for Peripheral Connectors and Cables Probe Holder removable for cleaning and washing Gel Holder removable for cleaning and washing Gel Warmer Int...

Page 176: ...graphy Option Display Modes Simultaneous Capability B or CrossXBeam PW B or CrossXBeam CFM or PDI B M B CrossXBeam Realtime Triplex Mode B or CrossXBeam CFM or PDI PW Selectable alternating Modes B or CrossXBeam PW B or CrossXBeam CFM PDI PW B CW option Colorized Image Colorized B Colorized M Colorized D Time line Display Independent Dual B or CrossXBeam PW Display CW Display 2 Display Formats Top...

Page 177: ...ilable in the US B Flow including B Flow Color Volume Navigation Scan Assistant DICOM 3 0 connectivity Report Writer Real Time 4D Physiological Input Panel Wireless LAN CW Doppler Tissue Velocity Imaging TVI Elastography TV Probe Holder Tomographic Ultrasound Imaging Volume Calculation VOCAL II Volume Contrast Imaging VCI Static Quantification Elastography not available in the US Color Flow PDI Vo...

Page 178: ...mission Focus Number Line Density Control Sweep Speed for M Mode of Angles for CrossXBeam PW Mode Gain Dynamic Range Acoustic Output Transmission Frequency PRF Wall Filter Spectral Averaging Sample Volume Gate for PW Mode Length and Depth Velocity Scale Doppler Audio Color Flow CFM Gain CFM Velocity Range Acoustic Output Wall Echo Filter Packet Size Frame Rate Control CFM Spatial Filter CFM Frame ...

Page 179: ...ndex RI Resistivity Index Vascular Measurements Calculations Carotid Vertebral Subclavian Measurements Auto IMT Summary Worksheet Summary Report Obstetrics Measurements Calculations Gestational Age Calculation Calculations and Ratios EFW Calculation Growth Percentiles Multi Gestational Calculation Fetal Qualitative Description Anatomical Survey Fetal Environmental Description Biophysical profile P...

Page 180: ...lic Abdomen OB GYN Pediatric S1 5 Sector Probe Applications Abdomen OB GYN S1 5 D Sector Probe Applications Abdomen OB GYN S4 10 Sector Probe Applications Pediatrics Neonatal Pediatric Cardiac 6S D Sector Probe Applications Pediatric Cardiac 6Tc Transesophageal Probe Applications Adult Cephalic RNA5 9 D Convex Volume Probe Applications Pediatric Neonatal RAB2 5 D Convex Volume Probe Applications A...

Page 181: ... Expected Service Life LOGIQ E9 system The expected service life for the LOGIQ E9 is at least seven 7 years from the manufacturing date under the provision of regular maintenance by authorized service personnel LOGIQ E9 Probes The expected service life for the LOGIQ E9 probes meets or exceeds five 5 years from the date the probe is placed in service under the provision that the customer follows th...

Page 182: ...loose or missing hardware Control panel and keyboard for defects Casters for proper locking operation CAUTION To avoid electrical shock hazard do not remove panels or covers from console This servicing must be performed by qualified service personnel Failure to do so could cause serious injury Electrical Hazard If any defects are observed or malfunctions occur do not operate the equipment but info...

Page 183: ...i Drive Filters weekly or as needed Footswitch Failure to perform required maintenance may result in unnecessary service calls Table 3 13 Appropriate Cleaning Agents Cleaning Agent LCD Monitor Glass LCD Frame Panel System Cabinet Touch Panel Operator Controls Mild Non Abrasive Soap and Water X X X X X Ammonia X X X Bleach 10 to 1 Ratio of 5 Home Bleach X X X Hydrogen Peroxide Hydrogen Peroxide Wip...

Page 184: ...TE The cloth should be damp not dripping wet 2 Wipe down the top front back and both sides of the system cabinet 3 Wipe off excess cleaning agents NOTE Do not spray any liquid directly into the unit Other acceptable cleaning agents are Ammonia Bleach 10 to 1 ratio of 5 home bleach Hydrogen Peroxide Hydrogen Peroxide Wipes Touch Panel To clean the Touch Panel 1 Moisten a soft non abrasive folded cl...

Page 185: ...sopropyl alcohol abrasive cleaners or other strong solvents as these may cause damage to the LCD Monitor LCD Frame To clean the LCD frame 1 Moisten a soft non abrasive folded cloth with a mild general purpose non abrasive soap and water solution NOTE The cloth should be damp not dripping wet 2 Wipe down the top front back and both sides of the LCD Frame 3 Wipe off excess cleaning agents Other acce...

Page 186: ...II manufactured by Pharmaceutical Innovations Inc Ammonia Bleach 10 to 1 ratio of 5 home bleach Hydrogen Peroxide Hydrogen Peroxide Wipes DO NOT USE T Spray I Original T Spray SaniCloth Plus red cap Any cleaning disinfecting solution containing Alcohol NOTE When cleaning the operator control panel make sure not to spill or spray any liquid on the controls into the system cabinet or in the probe co...

Page 187: ... Utility Touch Panel Figure 3 15 Utility Touch Panel NOTE After pressing Keyboard Lock the following pop up message appears Figure 3 16 Keyboard Locked Warning 2 Moisten a soft non abrasive folded cloth with a mild general purpose non abrasive soap and water solution 3 Wipe down operator control panel 4 Use a cotton swab to clean around keys or controls Use a toothpick to remove solids from betwee...

Page 188: ...ff NOTE CD type cleaner cannot be used Footswitch To clean the footswitch 1 Disconnect the footswitch from the LOGIQ E9 2 Moisten a soft non abrasive folded cloth with a mild general purpose non abrasive soap and water solution NOTE The cloth should be damp not dripping wet 3 Wipe the external surfaces of the unit then dry with a soft clean cloth HINTS Keeping your media disc in an original media ...

Page 189: ...Operator Panel you can use the manual release handle located at the back of the unit to manually move the Operator Panel up down To move the Operator Panel up down using the manual control 1 Locate the manual release handle which extends through the air vent at the back of the LOGIQ E9 Figure 3 17 Manual release handle 2 Move the manual release handle to the left with one hand while pushing up dow...

Page 190: ...ility It is recommended the filters be cleaned quarterly once every three months Locating The LOGIQ E9 has two air filters which need to be cleaned The top air filter A is located on the back of the LOGIQ E9 below the power cord and the bottom air filter B is located underneath the LOGIQ E9 Figure 3 18 Location of Air Filters CAUTION Be sure to lock the wheels before cleaning the air filters to av...

Page 191: ...ocate the metal handle extending from the air filter on the bottom of the LOGIQ E9 2 You may need two hands to remove this filter One hand is used to pull on the piece of cloth that extends from the filter and the other hand is used to wedge a finger just under a corner of the filter In this step firmly take hold of the metal handle that extends from the filter 3 Position your other hand at a corn...

Page 192: ... either new or refurbished To order these contact CARES in the US or call service in Europe and Asia The following supplies accessories have been verified to be compatible with the system Peripherals CAUTION DO NOT connect any probes or accessories without approval by GE Table 3 14 Peripherals and Accessories Accessory Part Number HCAT Sony B W Printer Model UP D897 5171608 H41392LZ Sony Color Pri...

Page 193: ...board H4908SY Norwegian Keyboard H4908NY Greek Keyboard H4908GY Russian Keyboard H4908RY Power Cord North American H4000ZA 5148381 Power Cord Argentina H4000ZH 5148381 9 Power Cord Europe H4000ZB 5148381 3 Power Cord UK Ireland H4000ZD 5148381 4 Power Cord Switzerland H4000ZL 5148381 7 Power Cord Denmark H4000ZE 5148381 8 Power Cord Israel H4000ZJ 5148381 10 Power Cord Japan H4000ZK 5148381 2 Powe...

Page 194: ...ket H40452LK L8 18i D V Nav Bracket H4908NH 9L D V Nav Bracket H4908NB C1 5 D V Nav Bracket H40432LF M5S D V Nav Bracket H4908NM S1 5 V Nav Bracket H4908ND ML6 15 D V Nav Bracket H40432LK S4 10 V Nav Bracket H4908NN RIC5 9 D V Nav Bracket H4908NG C2 9 D C1 6 D V Nav Bracket Starter Kit H4913NK C1 5 D V Nav Bracket Starter Kit H4913NL V Nav Needle Tracker Starter Kit H4910NT V Nav Needle Virtual Tr...

Page 195: ...irection 5454884 100 English Rev 1 ECG Accessories Table 3 17 ECG Accessories Accessory Part Number HCAT ECG Cables IEC AHA Style for Americas H4910EC ECG Cables IEC Style H4911JC ECG Cables IEC Style Short H44012LK ECG Cable Kit H45521AL ...

Page 196: ... Reusable Bracket H40432LE Yes H40432LF H4913NL Starter Kit C1 6 D Convex H40472LT Starter Kit H4913BB Yes H4913NK Starter Kit C2 9 D Convex H40462LN Multi Angle Disposable with a Reusable Bracket H4913BB Yes H4913NK Starter Kit M6C D Matrix Array Convex H40432LM Multi Angle Disposable with a Reusable Bracket E8385RF No N A IC5 9 D Micro Convex Intracavitary H40442LK Single Angle Disposable with a...

Page 197: ...inear H40452LG Multi Angle Disposable with a Reusable Bracket H40432LJ Yes H40432LK RAB2 5 D 4D Convex Volume H48651MN Single Angle Disposable with a Reusable Bracket Single Angle Reusable H4601AE H48621W No N A RAB4 8 D 4D Convex Volume H48651MP Same Brackets as RAB2 5 D H46701AE H48621W No N A RAB6 D 4D Convex Volume H48681MG Not Available N A No N A RIC5 9 D 4D Convex Volume Intracavitary H4865...

Page 198: ...eusable Starter Kit H47001AD H46721W H46701AD No P2D CW Split Crystal Pencil Probe H4830JE Not Available N A No N A P6D CW Split Crystal Pencil Probe H4830JG Not Available N A No N A 6Tc Trans esophageal Probe H45551ZD Not Available N A No N A Table 3 18 Probes and Accessories Continued Probe HCAT Global P N Japan P N Biopsy Guide Biopsy Guide HCAT V Nav Capable V Nav Bracket HCAT ...

Page 199: ...A Volume Navigation with Stand H4908N Volume Navigation with On Board Stand H4913NP Volume Navigation without Stand H4908NA Scan Assistant H4908SA Tomographic Ultrasound Imaging H4908TM DVR H4913DR Footswitch USB H46732LF ECG Module H4910EG Continuous Wave CW H4911C Wireless Lan WLAN H4913WL Elastography H4910E Elastography QAnalysis H4911EC Auto IMT H4910MT Tissue Velocity Imaging TVI H4910TY LOG...

Page 200: ...d H4913DL The LOGIQ E9 is designed for compatibility with commercially available Ultrasound contrast agents Because the availability of these agents is subject to government regulation and approval product features intended for use with these agents may not be commercially marketed nor made available before the contrast agent is cleared for use Contrast related product features are enabled only on...

Page 201: ...tles 12 case 1 gallon plastic jug Four 1 gallon plastic jugs Table 3 21 Disinfectant Accessory Units Cidex Activated Dialdehyde 16 1 quart bottles 4 1 gallon bottles 2 2 5 gallon bottles Table 3 22 Probe and Cord Sheath Sets Accessory Units Sterile Ultrasound Probe Sheath Set 20 Per Set Sterile Ultrasound Cord Sheath Set 20 Per Set Sanitary Rectal Vaginal Probe Cover 20 Per Set Sterile Combination...

Page 202: ...After the Exam is Over 3 76 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 ...

Page 203: ...LOGIQ E9 User Guide 4 1 Direction 5454884 100 English Rev 1 Chapter 4 Safety Describes the safety and regulatory information pertinent for operating this ultrasound system ...

Page 204: ... owner of the ultrasound unit should ensure that only properly trained fully qualified personnel are authorized to operate the system Before authorizing anyone to operate the system it should be verified that the person has read and fully understands the operating instructions contained in this manual It is advisable to maintain a list of authorized operators Should the system fail to operate corr...

Page 205: ...00 English Rev 1 Notice against user modification Never modify this product including system components software cables and so on User modification may cause safety hazards and degradation in system performance All modification must be done by a GE qualified person ...

Page 206: ...ound system specifically Maintaining an optimum system environment Using this Manual Notes to emphasize or clarify a point DANGER Indicates that a specific hazard is known to exist which through inappropriate conditions or actions will cause Severe or fatal personal injury Substantial property damage WARNING Indicates that a specific hazard is known to exist which through inappropriate conditions ...

Page 207: ... Hazard Describes precautions necessary to prevent the risk of injury through moving or tipping hazard Console accessories or optional storage devices that can fall on patient user or others Collision with persons or objects may result in injury while maneuvering or during system transport Injury to user from moving the console Moving Using brakes Transporting Acoustic Output Hazard Patient injury...

Page 208: ...erious injury The use of the system outside the descibed conditions or intended use and disregarding safety related information is considered abnormal use The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device Training assistance is available from GE Healthcare if needed Disregarding information on safet...

Page 209: ...on errors could result in an incorrect diagnosis The ultrasound system is not meant to be long term storage for patient data or images The customers are responsible for the data on the system and a regular backup is highly recommended It is advisable to back up system data prior to any service repairs to the hard drive It is always possible during system failure and repair to lose patient data GE ...

Page 210: ...ement errors or failure to detect details within the image The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions Applications training is available through the local GE representative Added confidence in the equipment operation can be gained by establishing a quality assurance program CAUTION The sys...

Page 211: ...d A damaged probe can also increase the risk of electric shock if conductive solutions come in contact with internal live parts Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry Become familiar with the probe s use and care precautions outlined in Probes and Biopsy CAUTION Ultrasound transducers are se...

Page 212: ... that may result from using an electrosurgical unit ESU To reduce the risk of HF burns avoid contact between the patient and ultrasound transducer while operating the ESU Where contact cannot be avoided as in the case of TEE monitoring during surgery make sure the transducer is not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducer cable CAUTI...

Page 213: ...son and contact a Service Representative for information There are no user serviceable components inside the console Refer all servicing to qualified service personnel only Ensure that unauthorized personnel do not tamper with the unit Electrical Hazard To avoid injury Do not remove protective covers No user serviceable parts are inside Refer servicing to qualified service personnel To assure adeq...

Page 214: ...ed All peripherals and accessories must be securely mounted to the LOGIQ E9 WARNING The LOGIQ E9 is not intended to be used as a data storage device backup of the Patient and Image Database is your institution s responsibility GE is NOT responsible for any lost patient information or for lost images DANGER The concerns listed below can seriously affect the safety of equipment and personnel during ...

Page 215: ...ff the unit CAUTION This equipment provides no special means of protection from high frequency HF burns that may result from using an electrosurgical unit ESU To reduce the risk of HF burns avoid contact between the patient and ultrasound transducer while operating the ESU Where contact cannot be avoided as in the case of TEE monitoring during surgery make sure the transducer is not located betwee...

Page 216: ...d reusable accessories after each patient examination and disinfect or sterilize as needed Refer to Probes and Biopsy for probe use and care instructions Follow all infection control policies established by your office department or institution as they apply to personnel and equipment CAUTION Contact with natural rubber latex may cause a severe anaphylactic reaction in persons sensitive to the nat...

Page 217: ...e NEVER place any object or liquid on the operator panel CAUTION Archived data is managed at the individual sites Performing data backup to any device is recommended CAUTION Make sure to verify the media after writing of data such as EZBackup SaveAs or Export Before deleting a patient or image from the patient screen make sure you have saved the data by EZBackup Backup or Export and verify that th...

Page 218: ...les away from ECG leads CAUTION DO NOT touch the patient and any of the connectors on the ultrasound unit simultaneously including ultrasound probe connectors DO NOT touch the conducting parts of the USB Ethernet Video Audio cables when connecting equipment to the unit CAUTION To minimize accidental loss of data perform EZBackup and Backup on a regular basis 1 First perform EZBackup to save the im...

Page 219: ...othing is within the range of motion before moving the monitor and monitor arm This includes both objects and people Pay attention to the monitor arm position to avoid hitting it against anyone or anything Before moving the system to another location be sure to lock LCD LCD arm in transport position The LCD screen may have defective pixels These pixels may appear as a slightly light or dark area o...

Page 220: ...additional safety precaution prevents exposed metal parts from becoming LIVE in the event of an insulation failure 2 Type BF Applied Part TYPE BF APPLIED PART providing a specified degree of protection against electric shock with particular regard to allowable LEAKAGE CURRENT 3 Type CF Applied Part TYPE CF APPLIED PART providing a degree of protection higher than that for Type BF Applied Part agai...

Page 221: ...mpt to correct the problem by one or more of the following measure s reorient or relocate the affected device s increase the separation between the equipment and the affected device power the equipment from a source different from that of the affected device consult the point of purchase or service representative for further suggestions NOTE The manufacturer is not responsible for any interference...

Page 222: ...quipment may characteristically cause electromagnetic interference with other equipment either transmitted through air or connecting cables The term EMC Electromagnetic Compatibility indicates the capability of equipment to curb electromagnetic influence from other equipment and at the same time not affect other equipment with similar electromagnetic radiation from itself Proper installation follo...

Page 223: ...ent as it may cause performance outside the published specifications Keep power to these devices turned off when near this equipment Medical staff in charge of this equipment is required to instruct technicians patients and other people who may be around this equipment to fully comply with the above regulation Table 4 4 Portable and mobile radio communications equipment distance requirements Frequ...

Page 224: ...to verify normal operation If abnormal operation is observed additional measures may be necessary such as re orienting or relocating the ultrasound system or using an RF shielded examination room may be necessary 1 Use either power supply cords provided by GE Healthcare or ones designated by GE Healthcare Products equipped with a power source plug should be plugged into the fixed power socket whic...

Page 225: ...esult in poor EMC performance of the product 2 Notice against User Modification The user should never modify this product User modifications may cause degradation in EMC performance Modification of the product includes changes in a Cables length material wiring etc b System installation layout c System configuration components d Securing system parts cover open close cover screwing 3 Operate the s...

Page 226: ...23 Digital Printer Sony UP D25 Digital Printer Sony UP D55 Digital Printer Canon PIXMA MP610 Digital Printer HP470 Report Printer DVR Drive Bay for Tru3D and Volume Navigation USB 2 0 Flash Drive Memory Stick Hard Disk Drive The LOGIQ E9 has also been verified for compatibility and compliance for connection to a local area network LAN via the rear panel Ethernet connection provided the LAN compone...

Page 227: ...plies with the requirements of the valid version of IEC60601 1 1 If in doubt consult the technical service department or your local GE Healthcare representative General precautions for installing an alternate on board device would include 1 The added device must have appropriate safety standard conformance and CE Marking 2 The total power consumption of the added devices which connect to the LOGIQ...

Page 228: ...tible interface 3 Signal or mains isolation devices and additional protective earth may be needed to assure compliance with IEC EN 60601 1 1 CAUTION The connection of equipment or transmission networks other than as specified in the user instructions can result in an electric shock hazard or equipment malfunction Substitute or alternate equipment and connections requires verification of compatibil...

Page 229: ...rgy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A This system is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes pro...

Page 230: ... 5454884 100 English Rev 1 Declaration of Immunity This system is suitable for use in the following environment The user must assure that the system is used according to the specified guidance and only in the electromagnetic environment listed ...

Page 231: ...erence may occur in the vicinity of equipment marked with the symbol IEC 61000 4 4 Electrical fast transient burst 2 kV for mains 1 kV for SIP SOP 2 kV for mains 1 kV for SIP SOP IEC 61000 4 5 Surge Immunity 1 kV differential 2 kV common 1 kV differential 2 kV common IEC 61000 4 11 Voltage dips short interruptions and voltage variations on mains supply 50T 95 dip for 0 5 cycle 400T 60 0ip for 5 cy...

Page 232: ...ability to display B mode image as input for diagnosis The ability to display M mode image as input for diagnosis The ability to display Doppler mode image as input for diagnosis The ability to display Color Flow mode image as input for diagnosis The display of acoustic power indexes as an aid for safe use of ultrasound diagnostic MI TIS TIB TIC ...

Page 233: ...ff USB Ports 2 Peripheral Devices DVD Multi Drive CD DVD DVR Patient I O ECG CW Probe Port V Nav Connectors 3 Network Disk Indicators USB Ports 4 Probe Ports 4 Probe Ports with CW Option 5 5 Imaging Probes 6 Wireless LAN 7 Power In Out Power Line AC Ground Line Power Cable with Protective Earth 8 Signals I O Port USB Ports Ethernet Connector Audio In Out DVI Port Connector S Video Connector ...

Page 234: ...NT See Peripheral Update for EC countries on page 4 24 for more information CAUTION DO NOT use unapproved devices If devices are connected without the approval of GE the warranty will be INVALID Any device connected to the LOGIQ E9 must conform to one or more of the requirements listed below 1 IEC standard or equivalent standards appropriate to devices 2 The devices shall be connected to PROTECTIV...

Page 235: ...stem display monitor the acoustic output display provides the operator with real time indication of acoustic levels being generated by the system See the Acoustic Output chapter in the Advanced Reference Manual for more information This display is based on NEMA AIUM Standards for Real time Display of Thermal and Mechanic Acoustic Output Indices on Diagnostic Ultrasound Equipment CAUTION Allowing t...

Page 236: ...in steps of 0 01 and for values greater than 0 4 increments in steps of 0 1 Thermal Index Depending on the examination and type of tissue involved the TI parameter will be one of three types Soft Tissue Thermal Index TIS Used when imaging soft tissue only it provides an estimate of potential temperature increase in soft tissue Bone Thermal Index TIB Used when bone is near the focus of the image as...

Page 237: ...each application could specify a different TI type Display precision is 0 1 and accuracy is 50 Accuracy of the power output displayed value on the Touch Panel is 10 Controls Affecting Acoustic Output The potential for producing mechanical bioeffects MI or thermal bioeffects TI can be influenced by certain controls Direct The Acoustic Output control has the most significant effect on Acoustic Outpu...

Page 238: ...e system is powered on or New Patient is selected To modify acoustic output adjust the Power Output level on the Touch Panel HINTS Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output such as Gain and TGC WARNING Be sure to have read and understood control explanations for each mode used before attempting to adjust the Acoustic Out...

Page 239: ... Identification and Rating Plate Manufacturer s name and address Rear Panel Rating Plate Probes Identification and Rating Plate Date of manufacture Rating Plate Probes Serial Number Rating Plate Probes Catalog Number Rating Plate Probes Type Class Label Used to indicate the degree of safety or protection Rear Panel United States only Prescription Requirement label Rear Panel CE Mark The CE Mark of...

Page 240: ...C 60417 5334 Probes Type CF Applied Part heart in the box symbol is in accordance with IEC 60878 02 03 CW Probe Connector Patient Cardiac Connectors Probes Type CF Defib Proof Applied Part heart in the box with paddle symbol is in accordance with IEC 60878 02 06 ECG Connector Probes ATTENTION Consult accompanying documents is intended to alert the user to refer to the operator manual or other inst...

Page 241: ...entiality indicates the terminal to be used for connecting equipotential conductors when interconnecting grounding with other equipment Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high risk patient environment to provide assurance that all equipment ...

Page 242: ...s lowered Label hidden when in down position GOST Symbol Russia Regulatory Country Clearance Rear Panel 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 system the backlight lamps in the monitor display contain mercury Rear Panel ETL Listing Mark Monogram Rear Panel The product has been tested...

Page 243: ...ry or damage to any assets China Rating Plate Indicates the presence of hazardous substance s above the maximum concentration value Maximum concentration values for electronic information products as set by the People s Republic of China Electronic Industry Standard SJ T11364 2006 include the hazardous substances of lead mercury hexavalent chromium cadmium polybrominated biphenyl PBB and polybromi...

Page 244: ... arm to avoid injury when moving the monitor and monitor arm Rear of the LCD monitor DO NOT push the system Use the handle to push pull the system e g DO NOT use the LCD Failure to do so may cause serious injury or system damage Rear of the LCD monitor Rear of On board V Nav Stand Table 4 7 Label Icons Continued Label Icon Purpose Meaning Location ...

Page 245: ...Device Labels LOGIQ E9 User Guide 4 43 Direction 5454884 100 English Rev 1 Warning Label Locations Figure 4 2 Rear Panel Label Location ...

Page 246: ... 10 ATTENTION Consult accompanying documents is intended to alert the user to refer to the operator manual or other instructions when complete information cannot be provided on the label 11 Possible shock hazard Do not remove covers or panels No user serviceable parts are inside Refer servicing to qualified service personnel 12 The equipment weighs approximately 135 kg 298 lbs To avoid possible in...

Page 247: ...gure 4 3 Peripheral Accessory Connector Panel Table 4 9 Accessory Connector Panel Explanations 1 USB Ports 2 Ethernet Connection 3 Possible shock hazard Do not remove covers or panels No user serviceable parts are inside Refer servicing to qualified service personnel 4 DVI Port Connector 5 Audio In Out 6 S Video ...

Page 248: ...TECTIVE EARTH NOTE Grounding reliability can only be achieved when this equipment is connected to a receptacle marked Hospital Only or Hospital Grade For U S A Canada Japan 2 Warning Dangerous voltage the lightning flash with arrowhead is used to indicate electric shock hazards 3 Possible shock hazard Do not remove covers or panels No user serviceable parts are inside Refer servicing to qualified ...

Page 249: ...s LOGIQ E9 User Guide 4 47 Direction 5454884 100 English Rev 1 Warning Label Locations continued Figure 4 5 Rating Plate USA Asia 120V console Figure 4 6 Caution Label on the LCD Monitor Figure 4 7 Footswitch Label ...

Page 250: ...Safety 4 48 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 ...

Page 251: ...e trace 2 23 circumference and area trace 2 21 distance 2 19 Body Patterns 2 13 brake location 1 23 brightness video 1 17 C Care and maintenance cleaning the system 3 58 air filter 3 64 footswitch 3 62 operator controls 3 60 system cabinet 3 58 inspecting the system 3 56 maintenance schedule 3 57 Caution icon defined 4 4 CINE gauge display location 1 16 CINE mode activating 2 12 circuit breaker de...

Page 252: ...s 3 12 hazards safety symbols 4 5 hazards types biological 4 12 4 14 electrical 4 9 4 11 explosion 4 12 mechanical 4 9 I Image History description 1 69 Indications for Use 1 3 information requesting 3 42 L left side view console 1 7 LOGIQ system contraindications 1 4 Indications for Use 1 3 M measurement controls location 2 17 Measurement Summary window display location 1 16 M Mode measurements mo...

Page 253: ...4 9 mechanical hazards 4 9 patient identification 4 7 patient training ALARA 4 10 personnel 4 11 precaution icons defined 4 4 precaution levels defined 4 4 probes handling precautions 3 3 service requesting 3 42 system electrical configurations 1 5 power down 1 25 System cabinet 3 58 system messages display location 1 16 T TAMAX and TAMEAN Doppler mode measurement manual trace 2 27 Time interval D...

Page 254: ...Index 4 LOGIQ E9 User Guide Direction 5454884 100 English Rev 1 ...

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