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Siemens Acuson S2000, Instructions For Use Manual

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Appendi x D  On-screen Controls  

D - 14 

Instructions for Use 

Selection 

Description 

Balance 

Image Optimization Preset 
Applies the selected image optimization settings for 2D-mode images.  
Available settings depend on the transducer and exam type. 

Note: 

The system displays 

CA

, 

Mix

, or 

2D

 when contrast agent imaging is activated. 

 

Contrast 

 

Detail 

 

Penetration 

 

Soft 

 

General 

 

LVO 

 

Fetal Echo 

 

1st Trimester 

 

User-Defined 

  (user-defined image presets) 

Note: 

The 

User-Defined

 setting is available only when a user-defined exam is selected. Use 

this setting to save a customized image optimization preset.  

Note:

 For systems without a touch screen, the selection is on the LED panel.

 

Timer

 

Start Timer

/

Stop Timer

 

Activates or deactivates the on-screen timer. 

Focus Points 

Focus 

Selects the required number of focal zones. 

Size 

Size

 

Changes the size of the 2D image. 

Summary of Contents for Acuson S2000

Page 1: ...Siemens Medical Solutions USA Inc 11286694 ABS 001 01 01 ACUSON S1000 ACUSON S2000 ACUSON S3000 Diagnostic Ultrasound System Instructions for Use ...

Page 2: ...nal purposes only Siemens does not endorse third party products referenced in the user documentation Siemens does not assume responsibility for the performance of third party products Siemens reserves the right to change its products and services at any time In addition this publication is subject to change without notice CE Declaration This product is provided with a CE marking in accordance with...

Page 3: ...cer accessories and an explanation of the biopsy puncture function including a procedure for needle path verification Chapter 6 Transesophageal Transducer Description of the transesophageal transducer including cleaning and care information for the transducer Chapter 7 Specialty Transducers Description of the following specialty transducers 9EVF4 Chapter 8 Physiologic Function Explanation of the P...

Page 4: ...ll controls and keys on the control panel alphanumeric keyboard and optional footswitch Appendix D On screen Controls Explanation of the on screen controls for imaging review measurements and patient data management Appendix E Advanced Feature Controls Explanation of the on screen controls for advanced imaging features and clinical application programs Appendix F Acoustic Output Reference Acoustic...

Page 5: ...xamination fundamentals and the biopsy function Procedures and descriptions of specialty transducers the physiologic function and the following imaging features eSieFusion imaging Virtual Touch applications Descriptions of system controls Acoustic output data Features and Applications Reference Descriptions of image acquisition and optimization including optional imaging features General and exam ...

Page 6: ... without a touch screen Except where noted in the manuals numbered steps apply to both systems Warnings Cautions and Notes WARNING Warnings are intended to alert you to the importance of following the correct operating procedures where risk of injury to the patient or system user exists Caution Cautions are intended to alert you to the importance of following correct operating procedures to preven...

Page 7: ...below Example Convention Push DEPTH Press E to access the advanced imaging features Rotate the FORWARD BACKWARD control to skip the current view in a protocol Press TEQ to activate or deactivate tissue equalization optimization To insert a body marker press ANNOTATION and then select the required body marker Rotate 2D to adjust the 2D gain Press M to activate the M cursor line on the 2D image Keys...

Page 8: ...pensation Roll the trackball to adjust the size of the field of view LED Controls For systems without a touch screen The six controls directly below the LED panel are not labelled on the control panel In this manual you can identify the function assigned to the control by the text in boldface type within brackets as shown below Example Convention Press or rotate EI Color to select a color map Soft...

Page 9: ...Press or rotate EI Color to select a color map Procedures In this manual procedures include the following conventions to describe user actions Note Press POINTER to display the cursor on the image screen if necessary Term Description Press The action of pressing a control on the control panel Rotate The action of rotating a control on the control panel Select The action of highlighting an on scree...

Page 10: ...Advanced training in imaging physics with typically four to six years of post doctoral training in the field of cardiology Maternal fetal Medicine Obstetrician Perinatologist Performs ultrasound exams Interprets exam data Writes and assembles exam findings in a report Medical doctor Manages high risk obstetrical patients for the safe and successful delivery of the fetus Skilled in interpreting ult...

Page 11: ...se 9 Contraindications 9 ACUSON S1000 Ultrasound System 9 Indications for Use Statement 10 ACUSON S2000 Ultrasound System 11 Indications for Use Statement 11 ACUSON S3000 Ultrasound System 12 Indications for Use Statement 12 Transducers and Intended Applications 13 Image Screen Layout 19 Screen Saver 19 Sample Image Screens 20 ...

Page 12: ...1 Introduction 1 2 Instructions for Use ...

Page 13: ...surements body markers annotations patient reports and system diagnostics The system design is based upon image quality knowledge based workflow adaptive ergonomics and innovative applications Operating modes for the system include 2D mode 2D mode with THI Tissue Harmonic Imaging Dual mode 2D M mode M mode with THI M mode with CDV Pulsed Wave Doppler Color Doppler Energy CDE Color Doppler Velocity...

Page 14: ...1 Introduction 1 4 Instructions for Use System Review Example of the ultrasound system ...

Page 15: ...ic keyboard 3 User adjustable control panel height and swivel 4 Front handle 5 Cable hanger 6 Retractable alphanumeric keyboard for systems with a touch screen 7 Transducer ports 8 Auxiliary continuous wave Doppler transducer port 9 Footswitch connector 10 Central brakes 11 Front swivel wheels 12 Parking port for transducers 13 Physio panel 14 CD DVD RW drive 15 Transducer and gel holders 16 Power...

Page 16: ...ructions for Use Example of the ultrasound system back view 1 Rear handle 2 Cable hanger 3 Input output panel with audio and video connections 4 Rear swivel wheel with brake 5 AC tray panel 6 Back panel 7 Storage bin 8 Shelf ...

Page 17: ... keys and controls are logically arranged to require a minimum number of hand and eye movements Example of Control Panel Example of the control panel and touch screen on the ultrasound system 1 Power on off For systems without a touch screen the power on off control the backlighting and task lighting control the volume control and microphone control and transmit power control are located above the...

Page 18: ...ut a touch screen six controls on the control panel have corresponding selections on the LED panel Additionally the image menu includes the mode specific optimization parameters and functions measurement labels and tools review selections and the access to exam types and transducers For systems without a touch screen this location includes soft key selections available for the active mode or funct...

Page 19: ...pecific to in vitro fertilization IVF chorionic villus sampling CVS and percutaneous umbilical cord blood sampling PUBS procedures Observe local laws and regulations Contraindications The ultrasound system is not intended for ophthalmic use or any ophthalmic application causing the acoustic beam to pass through the eye ACUSON S1000 Ultrasound System The ACUSON S1000 ultrasound system supports the ...

Page 20: ...junctively with other medical data obtained by a physician for clinical diagnosis purposes syngo Arterial Health Package AHP The Arterial Health Package AHP software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer reviewed studies The information is intended to provide the physi...

Page 21: ...usculo skeletal conventional musculo skeletal superficial and neonatal cardiac and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes syngo Arterial Health Package AHP The Arterial Health Package AHP software provides the physician with the capability to measure Intima Media Th...

Page 22: ...usculo skeletal conventional musculo skeletal superficial and neonatal cardiac and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes syngo Arterial Health Package AHP The Arterial Health Package AHP software provides the physician with the capability to measure Intima Media Th...

Page 23: ...gned and tested to withstand such interference and will not be permanently damaged See also Electromagnetic Emissions and Immunity Guidance and Manufacturer s Declaration WARNING In accordance with Canadian law the 14L5 SP transducer is not licensed for use with the ACUSON S1000 ultrasound system or the ACUSON S3000 ultrasound system Transducer Name Operating Frequency1 Modes of Operation2 Intende...

Page 24: ...Hz 14 0 MHz Doppler 5 5 MHz 9 0 MHz 2D C D M Intraoperative Small Organ Peripheral Vessel Musculo skeletal Conventional 18L6 HD 2D mode 7 0 MHz 17 0 MHz Doppler 5 5 MHz 10 0 MHz 2D C D M Small Organ Peripheral Vessel Musculo skeletal Conventional Musculo skeletal Superficial Curved and Linear Array Transducers Available only on the ACUSON S2000 system and the ACUSON S3000 system 6C1 HD 2D mode 1 5...

Page 25: ... 4V1c 2D mode 1 75 MHz 4 64 MHz Doppler 1 8 MHz 3 5 MHz 2D C D M CW Abdominal Pediatric Adult Cephalic Cardiac Other Neonatal Cardiac 8V3 2D mode 4 0 MHz 8 0 MHz Doppler 2 5 MHz 5 0 MHz 2D C D M CW Fetal Pediatric Neonatal Cephalic Cardiac Other Neonatal Cardiac 10V4 2D mode 4 0 MHz 10 0 MHz Doppler 4 5 MHz 6 0 MHz 2D C D M CW Fetal Abdominal Pediatric Neonatal Cephalic Cardiac Peripheral Vessel 4...

Page 26: ... C D M CW Pediatric Cardiac Intracardiac Other Intraluminal AcuNav 10F 2D mode 4 0 MHz 10 0 MHz Doppler 4 0 MHz 6 5 MHz 2D C D M CW Pediatric Cardiac Intracardiac Other Intraluminal Endocavity Transducers Available on the ACUSON S1000 system ACUSON S2000 system and ACUSON S3000 system EV 8C4 2D mode 4 0 MHz 9 0 MHz Doppler 4 2 MHz 6 75 MHz 2D C D M Fetal Abdominal Transvaginal EC9 4 2D mode 4 0 MH...

Page 27: ...ers Available on the ACUSON S1000 system ACUSON S2000 system and ACUSON S3000 system 7CF1 2D mode 3 0 MHz 7 0 MHz Doppler 2 5 MHz 3 75 MHz 2D C D M Fetal Abdominal 7CF2 2D mode 3 0 MHz 7 0 MHz Doppler 2 5 MHz 3 75 MHz 2D C D M Fetal Abdominal 9EVF4 2D mode 4 0 MHz 9 0 MHz Doppler 4 0 MHz 7 5 MHz 2D C D M Fetal Neonatal Cephalic Transvaginal ...

Page 28: ...nic imaging not including contrast Doppler Pulsed wave continuous wave and color imaging 2 Modes of Operation Includes one or more of the following system operating modes 2D brightness mode 2D mode 2D mode with Tissue Harmonic Imaging THI C color flow Doppler Color Doppler Velocity CDV Color Doppler Energy CDE D Doppler Pulsed Wave Doppler 2D Doppler 2D Doppler with CDV 2D Doppler with CDE M motio...

Page 29: ... imaging parameters section of the screen System Config Image Text Editor Screen Saver The screen saver feature automatically freezes the system and replaces the active display with a screen saver display after the system has been inactive for a specified number of minutes Exit the active screen saver display by pressing any key adjusting any control or rolling the trackball When the security pack...

Page 30: ... of stored clips images and volumes Use the arrows on either end of the thumbnail panel to scroll the thumbnails 6 Displays information about the network connection and network job status 7 Controls for printing and deleting thumbnails 8 Trackball status Indicates the function currently assigned to the trackball and the controls adjacent to the trackball For systems without a touch screen this loc...

Page 31: ... 21 Defibrillators 22 Defibrillator Use and the ACUSON AcuNav Ultrasound Catheter 22 Implantable Devices 22 Possible Combinations with Other Equipment 23 Maintaining Data Integrity 23 Data Compression 23 Caring for the Ultrasound System 24 Daily Checklist 24 Maintenance 25 Repair 25 Siemens Authorized Care 25 Caring for Documentation and Storage Devices 26 Caring for the Battery Pack 26 Recharging...

Page 32: ...L5 SP 46 Caring for Transducer Accessories 47 Transducer Sheaths 47 Storage 47 Gel Pad 48 Storage 48 Needle Guide Bracket Kits 48 Storage and Transportation 48 Cleaning Disinfecting and Sterilizing Transducer Accessories 49 Needle Guide Bracket Kits 49 Environmental Protection 51 Product Recycling and Disposal 51 Hazardous Substances 51 Caring for Batteries 51 Recycling Batteries 52 Disposing of t...

Page 33: ... Risk of explosion if used in the presence of flammable anesthetics Caution Risk of electric shock Do not open Refer servicing to qualified service personnel Consult instructions for use It is mandatory you refer to the manual blue illustration Caution black illustration Note For systems and transducers shipped from the factory prior to 1 October 2010 the symbol means Caution consult accompanying ...

Page 34: ...dicator Light Status Indicator for DC Power Good Green or Green Indicator Light Printer Connection Type BF Defibrillator proof Patient Connection Type BF Applied Part Type B Patient Connection Continuous Wave Transducer Port Transducer Port ECG Signal Connection Electrocardiogram EKG Signal Input Signal Output ...

Page 35: ...rning The product must be properly disposed of in accordance with local state and regional laws and regulations Products bearing this symbol are subject to the European Community directive 2002 96 EC on waste electrical and electronic equipment WEEE amended by directive 2003 108 EC For collection and disposal of the product its components or its accessories contact your local Siemens representativ...

Page 36: ...for Canada and United States of America UL classified symbol for Canada and United States of America EAC Eurasian Conformity mark The Eurasian Conformity mark is a product marking to indicate that the product conforms to all Technical Regulations of the Customs Union assessment procedures Equipment complies with the standard and specifications published by IMDA Info communications Media Developmen...

Page 37: ...the safety requirements of Russian state standards Caution In the United States of America federal law restricts this device to sale or use by or on the order of a physician Safe working load XXX represents the weight of the system unpacked and ready for operation with documentation devices installed Additional objects or devices on the system cannot exceed the safe working load Transducer storage...

Page 38: ...number Quantity of product Siemens model number Device part number Manufacturer country of origin United States of America Manufacturer country of origin Republic of Korea Manufacturer country of origin Japan Manufacturer country of origin Netherlands Date of Manufacture symbol with the date below Manufacturer ...

Page 39: ...n for MAINS 100V 50 60 Hz 15A maximum draw 15A MAINS breaker Identifies voltage frequency and current rating of system configuration for MAINS 115V 50 60 Hz 12A maximum draw 15A MAINS breaker Identifies voltage frequency and current rating of system configuration for MAINS 230V 50 60 Hz 6 5A maximum draw 7 5A MAINS breaker Identifies voltage and circuit breaker current ...

Page 40: ...in inches Do not stack Recycle Storage atmospheric pressure range example Storage humidity range example Indicates this side up Do not stack Shipping weight example Do not allow to get wet Fragile Handle with care Refer to the operator s manual for information about compatible needle guides Environmentally friendly use period Intentional transmitter of non ionizing radiation ...

Page 41: ...2 Safety and Care Instructions for Use 2 11 Labels Location of labels on the ultrasound system example 1 System warning label with certification labels ...

Page 42: ...nd Care 2 12 Instructions for Use 1 Identification label 2 Country specific labels 3 Country specific labels Example of system label 1 Product name 2 System input power requirement Example of identification label ...

Page 43: ...rts of severe allergic reactions to medical devices containing latex natural rubber Health care professionals are advised to identify latex sensitive patients and to be prepared to treat allergic reactions promptly For additional information in the U S A refer to FDA Medical Alert MDA91 1 WARNING Ultrasound energy is transmitted more effectively through water than through tissue When using a stand...

Page 44: ...is time Ultrasound examination performed solely to satisfy the family s desire to know the fetal sex to view the fetus or to obtain a picture of the fetus should be discouraged In addition visualization of the fetus solely for educational or commercial demonstrations without medical benefit should not be performed In August 1994 the Food and Drug Administration FDA notified the medical community a...

Page 45: ...rates an output display of Mechanical and Thermal Indices to allow you to monitor and to limit the amount of ultrasound energy that is transferred to the patient Example of the mechanical and thermal indices and the transmit power display on the image screen 1 Mechanical and thermal indices 2 Transmit power display Note For ultrasound systems distributed in the United States of America refer to th...

Page 46: ...nly function that affects the mechanical and thermal indices The range and especially the maximum level of the mechanical and thermal indices differ depending on the transducers In addition each diagnostic exam type has preset values for mechanical and thermal indices Note Maximum transmit acoustic intensity and the mechanical index for each exam type is limited in accordance with the United State...

Page 47: ...crease transmit power Rotate the Power control counterclockwise to decrease transmit power For systems without a touch screen rotate the Power LED panel control clockwise to increase transmit power Rotate the Power control counterclockwise to decrease transmit power Transmit Power Display The transmit power range is from 0 to 100 Selecting 100 in combination with other ultrasound system controls o...

Page 48: ...ustment of the following imaging functions and or controls may affect the acoustic output Automatic Time out Imaging Mode Color Ensemble Size Line Density Resolution Color ROI Position M mode ROI Position Color ROI Size Multi Frequency Doppler Gate Position Power On Off Doppler Color PRF Presets Doppler Gate Size Reset Exam Type Transducer Field of View Scan Angle Transmit Power Focus Update Frame...

Page 49: ... C 38 0 C 6C2 40 1 C 40 0 C 8C3 HD 41 0 C 42 5 C 9L4 39 4 C 38 1 C 12L4 42 5 C 47 0 C 14L5 41 7 C 41 1 C 14L5 SP 40 7 C 40 5 C 18L6 HD 42 9 C 43 0 C 4P1 40 9 C 42 6 C 4V1 40 3 C 40 8 C 4V1c 42 3 C 46 0 C 8V3 41 4 C 41 0 C 10V4 37 7 C 36 5 C V5Ms 36 4 C 39 4 C V7M 42 6 C 40 3 C EV 8C4 38 9 C 39 6 C EC9 4 36 0 C 36 7 C MC9 4 42 5 C 45 3 C 7CF1 38 6 C 45 0 C 7CF2 36 7 C 37 2 C 9EVF4 38 4 C 38 3 C CW2...

Page 50: ...ne must be powered from a medically isolated power source or must be a medically isolated device Equipment powered from a non isolated source can result in chassis leakage currents exceeding safe levels Chassis leakage current created by an accessory or device connected to a non isolated outlet may add to the chassis leakage current of the ultrasound system WARNING Using an extension cord or multi...

Page 51: ...aintain the safety and functionality of the ultrasound system maintenance must be performed every 24 months Electrical safety tests must also be performed at regular intervals as specified by local safety regulations or as needed EMC Note Proximity to sources of strong electromagnetic fields such as radio transmitter stations or similar installations may lead to interference visible on the monitor...

Page 52: ...effects of defibrillation There are no exposed conductive surfaces distal to the handle Within the flexible shaft a chassis ground shield covers all active circuits and conductors Recovery Time After Defibrillation During a Catheter Procedure If you disconnect the SwiftLink catheter connector from the ultrasound system before defibrillation the recovery time after defibrillation is equal to the ti...

Page 53: ...tant Information To ensure data integrity To prevent the loss of data that results from power failures and other system down occurrences you must archive important data such as patient records onto an external recording media such as a CD or a network Loss of data is to be expected and its retrieval is not normally possible under the following conditions loss of power to the ultrasound system hard...

Page 54: ...must visually inspect a transducer prior to use Do not use a transducer that has a cracked punctured or discolored casing or a frayed cable Discoloration Exception The use of approved cleaners and disinfectants may cause discoloration of the transducer You can continue to use a transducer discolored due to the use of approved cleaners and disinfectants only Perform the following each day before us...

Page 55: ...anufacturers and installers of ultrasound equipment Siemens cannot assume responsibility for the safety properties reliability and or performance of the equipment if Installations extensions readjustments modifications additions or repairs are carried out by persons not specifically authorized by Siemens Components that affect the safe operation of the system are replaced by parts not authorized b...

Page 56: ...the system is disconnected frequently from the AC power for a duration of greater than four to eight hours replace the battery every 12 to 18 months When the system is only occasionally disconnected from the AC power for a duration of approximately four hours replace the battery every three years 1 Battery pack charge indicator LED 2 AC OK indicator LED 3 Mains ON OFF circuit breaker Example of an...

Page 57: ...t be removed to access the battery pack Battery pack location 1 Storage bin cover 2 Battery pack location 3 Battery symbol To remove the storage bin cover 1 Grasp the cover by the top right edge above the battery location and gently pull to unsnap the first of four fastener pins from its receptacle 2 Support the cover near each fastener as you pull working downward and toward the left until the co...

Page 58: ...ing a Battery Pack Caution There is only one correct orientation for attaching the battery connector Do not force or twist the connector because doing so can damage the battery pack and the ultrasound system To install a battery pack 1 Orient the battery pack connector at the end of the battery cable with the receptacle on the ultrasound system located within the battery recess Firmly push them to...

Page 59: ... disinfection efficacy and appropriate clinical uses WARNING The use of any disinfectants other than those specified in the instructions for use may damage the ultrasound system and accessory surfaces and as a result may create electrical hazards for the patients and or users Caution To avoid the possibility of static shock and damage to the ultrasound system avoid the use of aerosol spray cleaner...

Page 60: ...o the control panel keyboard or any other openings 3 After cleaning use a clean lint free cloth to dry the surface 4 As required use an approved disinfectant wipe to disinfect the ultrasound system and accessories 5 Reconnect the ultrasound system power cord into the power outlet Clean and disinfect the holders for transducers and coupling gel 1 Remove the holder from the ultrasound system a Reach...

Page 61: ...ind the point of attachment for the gel warmer b Reach under the gel warmer to locate the tab on the gel warmer The tab extends below the point of attachment to the ultrasound system c Squeeze the tab towards the gel warmer and pull the gel warmer downward 2 Unplug the power cable from the gel warmer 3 Clean and disinfect the gel warmer using an approved disinfectant wipe 4 Reattach the gel warmer...

Page 62: ...e the ring and trackball 2 Clean the ring and trackball with a cotton swab or lint free pad moistened with mild detergent solution 3 Clean the inside of the trackball assembly with a cotton swab or lint free pad moistened with mild detergent solution 4 As required use an approved disinfectant wipe to disinfect the ring trackball and trackball assembly 5 Allow the trackball components to completely...

Page 63: ...pproved disinfectant wipes for use on the ultrasound system and surfaces of the listed accessories Sani Cloth Sani Cloth Bleach Wipe Sani Cloth HB Sani Cloth Plus Super Sani Cloth Ultrasound System Transducer Holders Trackball Assembly Gel Warmer or any bleach wipe with 1 sodium hypochlorite and no other active ingredients approved NA not approved ...

Page 64: ...ltrasound system has one removable washable air filter This air filter must be cleaned regularly to maintain proper system cooling Check the air filter weekly and clean as needed Clean and reinstall the air filter according to the following instructions Example of the location of the air filter 1 Location of back panel air filter ...

Page 65: ... running water and allow the filter to completely dry To hasten drying you may gently shake the filter or blot the filter with a clean lint free cloth Caution Do not insert a wet filter as this can damage the system 5 Replace the air filter into the tray positioning the filter flat side down with the angled corners fitting into the back of the tray The filter will fit into the back corners of the ...

Page 66: ...age could cut the patient and compromise the electrical safety of the transducer causing possible patient or user injury Contact your local Siemens representative Caution Transducers are sensitive instruments irreparable damage may occur if they are dropped knocked against other objects cut or punctured Do not attempt to repair or alter any part of a transducer contact your local Siemens represent...

Page 67: ...nsitive parts of the transducer Be sure that all parts of the transducer are properly placed inside the case before you close the lid Storage Store transducers in a clean and dry environment Extreme temperatures or humidity may damage a transducer See also Technical Description Appendix A Instructions for Use Repair Do not attempt to repair or alter any part of the transducer Contact your service ...

Page 68: ...dministration FDA Example of Transducers Use Required Method Classification Intraoperative Laparoscopic Sterile body tissue Cleaning and sterilization Critical Endocavity Transesophageal Intact mucous membranes Cleaning and high level disinfection Semi critical Non invasive Non intact skin Cleaning and high level disinfection Semi critical Non invasive Intact skin Cleaning and low level disinfecti...

Page 69: ...nsducer 4 Cable 5 Strain relief for the connector 6 Connector 7 Electrical component on the connector Example of transducer components 1 Transducer surface in contact with the patient 2 Handle 3 Strain relief for the transducer 4 Cable 5 Strain relief for the connector 6 Connector 7 Electrical component on the connector Example of endocavity transducer components ...

Page 70: ...exible shaft with depth markings articulating section and distal tip 2 Strain relief for the handle 3 Cable 4 Strain relief for the connector 5 Electrical component on the connector 6 Connector 7 Handle with controls 8 Strain relief for the handle Example of transesophageal transducer components ...

Page 71: ...Protection level IPX8 of EN 60529 and IEC 60529 to the depth of the immersion line shown in the illustration Endocavity transducers exceed minimum Ingress Protection level IPX7 of IEC 60601 2 18 to the depth of the immersion line shown in the illustration Note Intraoperative transducers are immersible up to the strain relief on the connector Example of immersion levels 1 Endocavity 2 Linear 3 Curv...

Page 72: ... designed and tested to be able to withstand disinfection as recommended by the manufacturer of the disinfectant product Carefully follow the disinfectant manufacturer s instructions Do not immerse for more than one hour Caution Do not use abrasive cleaners organic solvents such as benzene isopropyl alcohol or phenol based substances cleaners or disinfectants containing organic solvents to clean o...

Page 73: ...ticles from the transducer prior to disinfection moisten a clean gauze pad or cloth with water or an approved cleaner and then wipe the transducer Avoid touching the electrical components on the connector See also For a list of approved cleaners refer to p 2 44 5 Select an approved disinfectant for low level or high level disinfection Follow the disinfectant manufacturer s instructions for the req...

Page 74: ...ted degradation of imaging performance or transducer reliability You can use Gigasept FF as a cleaner and a disinfectant ENZOL Gigasept FF Transeptic 4C1 6C1 HD NA 6C2 7CF1 7CF2 8C3 HD NA EV 8C4 EC9 4 MC9 4 9EVF4 9L4 NA 12L4 NA NA 14L5 NA NA 14L5 SP NA NA 18L6 HD NA 4P1 NA NA 4V1 4V1c 8V3 10V4 V5Ms V7M CW2 CW5 approved NA not approved ...

Page 75: ... FF as a cleaner and a disinfectant CIDEX CIDEXPLUS CIDEX OPA Gigasept FF Milton PI Spray II Rely On Virkon Revital Ox RESERT HLD Sani Cloth AF3 Sani Cloth HB Super Sani Cloth 4C1 6C1 HD NA NA 6C2 7CF1 NA 7CF2 NA 8C3 HD NA NA EV 8C4 NA NA NA EC9 4 NA MC9 4 NA 9EVF4 NA 9L4 NA NA NA NA 12L4 NA NA NA NA NA 14L5 NA 14L5 SP NA 18L6 HD NA NA 4P1 NA 4V1 4V1c 8V3 10V4 NA V5Ms NA NA NA V7M NA NA NA NA CW2 ...

Page 76: ...zation manufacturer s instructions The STERRAD sterilization system a hydrogen peroxide gas plasma sterilization system is approved for use with the listed intraoperative transducer s 14L5 SP To sterilize a transducer with the STERRAD system Note This procedure applies to the 14L5 SP transducer only 1 Disconnect the transducer from the system 2 Thoroughly clean rinse and dry the transducer 3 Caref...

Page 77: ...transducers cannot be sterilized using hot steam cold gas or Ethylene Oxide EO methods Caution Siemens recommends that you follow all instructions provided by manufacturers of sterile goods transducer sheaths to ensure proper handling storage and cycling of all sterile goods Using a disposable latex transducer sheath on a transducer reduces the possibility of cross contamination Always use a prote...

Page 78: ... puncture procedures for specific transducers Storage and Transportation Always clean and sterilize or high level disinfect components used in a needle puncture or biopsy procedure after each use Refer to the in box instructions for storage and transportation information for all needle guide accessories except as noted below Storing or Transporting the EC 1 Bracket Kit Do not use the carrying case...

Page 79: ...ilization clean the bracket assembly To clean the bracket assembly 1 Rinse the bracket under water and remove all debris Avoid using a brush as it may damage the needle guide bracket 2 Visually inspect the guide to make sure all debris is removed 3 Wipe off water on the bracket assembly using a sterile cloth or sterile gauze To sterilize the bracket assembly Use sterile technique to perform this p...

Page 80: ...ocavity needle guide is a single use item Refer to the in box instructions for disposal instructions MC9 4 9EVF4 and EV 8C4 Stainless Steel Endocavity Needle Guide Kits WARNING Needle Guide Bracket kits are packaged non sterile Sterilize these products prior to their first use The stainless steel endocavity needle guide is a reusable item Refer to the in box instructions for attachment and care pr...

Page 81: ...to contact water or other fluids disassemble batteries allow conductive object to contact a battery s terminals cause a battery to become short circuited heat batteries or expose batteries to fire Any of these actions can compromise the structural integrity of a battery Compromising the structural integrity of a battery can result in battery leakage heat generation fire or explosion causing possib...

Page 82: ...e system clock no longer keeps time it could be time to replace the battery Contact your local Siemens representative battery packs nickel metal hydride Ni MH battery See also Caring for the Battery Pack p 2 26 The battery is rechargeable Recycle batteries according to local state and regional laws and regulations Use a battery collection program available in your country to recycle batteries To t...

Page 83: ...EVF4 and EV 8C4 needle guide bracket kits The stainless steel endocavity needle guide is a reusable item Refer to the in box instructions for attachment and care procedures including cleaning disinfection and sterilization Refer to the in box instructions for guidance regarding when to dispose of a damaged needle guide Refer to the in box instructions for disposal procedures for the single use com...

Page 84: ...2 Safety and Care 2 54 Instructions for Use ...

Page 85: ...ay Transducers 12 Continuous Wave Transducers 13 Protective Transducer Holder 13 Transducer Cable Management 14 Connecting System Accessories 15 Footswitch 15 Physio Cables 15 Gel Warmer 16 Virtual Communication for Remote Assistance 18 Connecting the Ultrasound System to a Network 19 Wired Connection 19 Wireless Connection 19 Network Connection Icons 20 System Security 21 Restricting User Access ...

Page 86: ...3 System Setup 3 2 Instructions for Use ...

Page 87: ...parations before moving the system are important to minimize potential damage to sensitive components and to avoid safety hazards Review the moving instructions before moving the system WARNING Do not park or leave unattended on a slope Even when the rear brakes are engaged the system may slide down a ramp The ultrasound system is designed to be a mobile unit Before moving the system to another lo...

Page 88: ...nter section of the front bumper from underneath firmly until the wheels are locked in a forward position using the top of your foot This is the highest position for the front bumper To release the swivel brakes Press the center section of the front bumper down with your foot until it clicks once This is the center position for the front bumper Using the Rear Brakes The rear brakes are set individ...

Page 89: ...r to the Move 1 Power OFF Briefly press and then release the power on off switch to power off the ultrasound system The power on off switch is located to the right of the CD R drive 2 Unplug cord Unplug the power cord from the wall outlet Pull on the plug NOT the cord If applicable also unplug the Ethernet cable 3 Secure components The following components must be secured or transported separately...

Page 90: ... during transport After the Move Caution Make sure the ultrasound system has proper ventilation during operation Do not position the system against walls or hard surfaces that would impede free ventilation around the system Caution Do not allow linens bedding and or hanging curtain partitions to block the ultrasound system s ventilation Caution Obstructed fans can cause potential system overheatin...

Page 91: ...n of the ultrasound system and other equipment The first step to operating the ultrasound system is to connect the system to a power source AC Tray Panel The AC tray panel on your system may have a connector cover for protection of the power cord 1 Power cord connector 2 Equipotential connector 3 Service diagnostic lights 4 MAINS circuit breaker I ON OFF Example of AC Tray panel with a connector c...

Page 92: ...cuit breaker is in the on position I ON When the system is powered on it runs through a series of self diagnostic and calibration tests after which the system is ready for use Note The system will not run through the complete power on routine if a problem occurs Instead an error code or message appears on the screen to indicate the problem Please note the message and call your local Siemens servic...

Page 93: ...ower on off switch to power off the ultrasound system 2 Select the Standby button on the displayed System Shut Down dialog box Note If the system detects errors that require a system shutdown then the Standby button is not available You can either select Cancel or power off the system If the system is transferring images then it will wait until the transfer is complete to power off Wait approximat...

Page 94: ...of the viewing monitor should be made prior to adjusting the print quality of installed documentation devices To adjust the screen brightness with the monitor controls 1 Press the menu control on the monitor The system displays the menu for approximately ten seconds Note To immediately dismiss the menu press the menu control 2 Adjust the screen brightness To increase the screen brightness press th...

Page 95: ...If a transducer is disconnected before the image is frozen the system will display an error message Select another transducer before continuing to use the system You can connect multiple transducers to the ultrasound system with one transducer being the active transducer 1 Three micro pinless MP ports for array transducers 2 Continuous wave transducer port Transducer ports ...

Page 96: ... 2 Insert the connector into the system port and turn the lock on the transducer connector clockwise until it locks in position This secures the connector in position and ensures the best possible contact 3 Place the transducer in the transducer holder Example of locked left illustration and unlocked right illustration positions of the transducer connector To disconnect an array transducer Caution...

Page 97: ...sm Continue pulling on the ring to remove the connector from the system port 2 Store each transducer in its protective carrying case 1 Connector 2 Retractable connector housing 3 Transducer cable Example of CW transducer connector Protective Transducer Holder Caution Transducer holders have variable sizes both in depth and diameter To avoid transducer damage you must use the holder or insert provi...

Page 98: ...to keep the transducer cable from contact with the floor After you have connected and secured a transducer drape the transducer cable through one of the cable hooks located on the ultrasound system These hooks provide support for the transducer cables keep cables off the floor and help to prevent tangling of the cables when more than one transducer is connected to the system ...

Page 99: ...ors to the Physio panel located on the left front of the system The optional Physio feature allows the system to display a scrolling ECG waveform on the image screen Note The Physio inputs are Defibrillation Proof However in the event of defibrillation while using the Physio function the Physio inputs may become saturated overloaded An ECG pattern may not be visible for up to 30 seconds After this...

Page 100: ... your local Siemens service representative immediately if your gel warmer appears to be damaged or malfunctions in any way See also Refer to the cleaning and disinfecting procedures in Chapter 2 in this manual When the ultrasound system is powered on the gel warmer continuously heats the bottle of gel inserted into the gel warmer Example of the gel warmer front view 1 Temperature control 2 Power c...

Page 101: ...d system b Align the support on the gel warmer directly below the point of attachment on the ultrasound system and firmly push upwards until the gel warmer snaps into place To use the gel warmer 1 Press the power on off control on the front of the gel warmer to power on the gel warmer if necessary The gel warmer power control illuminates when the gel warmer is powered on Note A blinking light indi...

Page 102: ...your service representative 1 Locate the camera and headset for use with the ultrasound system 2 Initiate the remote assistance session using the phone number provided by your Siemens representative 3 Follow the instructions provided by your service representative to set up the session of virtual communication including connections of the camera and headset The following ports on the input output ...

Page 103: ...pital network port If the ultrasound system is connected to a wireless network the ultrasound system disconnects from the wireless network The system then connects to the LAN through the wired connection and displays an icon at the bottom of the image screen indicating a wired connection Example of the icon displaying two monitors to indicate a wired connection The icon displaying one monitor indi...

Page 104: ... network and then click Connect Connect to a wireless network without a network profile 1 Click the Network Profiles tab 2 Under the Profile Names list click Add The tab displays the selections for configuring a new network profile 3 In the network profile selections enter the required settings for the wireless network and then click Save Note Consult your network administrator for the required se...

Page 105: ...he system Viewing studies stored on the ultrasound system Connecting to printers within the patient environment Backing up or restoring ultrasound system data Changing or applying new ultrasound system settings Tracking User Activities When the security package is activated the ultrasound system tracks user activities including access to patient data and saves the information to a security log fil...

Page 106: ... only guarantee the performance and safety of the devices listed in the Instructions for Use If in doubt consult the Siemens service department or your local Siemens representative Caution To ensure proper grounding and leakage current levels it is the policy of Siemens to have an authorized Siemens representative or approved third party perform all on board connections of documentation and storag...

Page 107: ...heral equipment itself is a medical device approved according to EN 60601 1 and IEC 60601 1 or Non medical peripheral equipment approved according to any other EN or IEC standard EN XXXXX or IEC XXXXX e g equipment complying with EN 60348 and IEC 60348 EN 60950 and IEC 60950 etc must use the following setup for connection Equipotential connector located on AC tray panel of the ultrasound system Co...

Page 108: ...nection and patient environment 1 Patient environment represented by shading extending exactly 1 5 meters 1 8 meters 6 feet in Canada and in the U S A around patient and ultrasound system 2 Ultrasound system 3 Peripheral equipment EN XXXXX and IEC XXXXX 4 Peripheral equipment power cord 5 Medically approved isolation transformer 6 Medically approved isolation transformer power cord 7 Printer data ...

Page 109: ...oard documentation devices are user installable An off board documentation device has a data cable connecting it to the ultrasound system but is connected to AC power separate from the ultrasound system An off board documentation device is located separately for example on a table next to the ultrasound system Up to three documentation devices in total may be connected to the ultrasound system All...

Page 110: ...ol are on the front handle of the ultrasound system Adjust the height of the monitor control panel and keyboard by pressing and holding the height adjustment control and pulling upward or pushing downward on the handle Example of the icon on the height adjustment control Note When two on board peripheral devices are installed you may not be able to adjust the height of the control panel Rotate the...

Page 111: ... Do This Install the system update Click Install Note Do not power off the ultrasound system while the installation is in progress The installation requires up to 40 minutes depending on the size of the system update The system restarts when the installation is complete If multiple system updates are ready for installation the system installs the first update and then prompts you to continue insta...

Page 112: ...3 System Setup 3 28 Instructions for Use ...

Page 113: ...ory OB or GYN 13 Changing the Exam Transducer Protocol or Patient Information 14 Imaging Overview 16 Priority Mode 18 2D Mode Overview 18 M Mode Overview 18 Color Flow Overview 19 Acoustic Streaming with Cysts 19 Doppler 20 Selecting an Operating Mode 20 Optimizing Images 20 Examples of Imaging Parameter Settings 20 Working with Mode Specific Menus 23 Performing Measurements and Calculations 25 Re...

Page 114: ...4 Examination Fundamentals 4 2 Instructions for Use ...

Page 115: ... the screen to prevent unauthorized access to patient information An active screen saver display also locks the screen A locked screen requires a user name and password to access the system See also For information about the screen saver refer to Chapter 1 in this manual The ultrasound system administrator also assigns permissions for each user account Permissions establish data access rights eith...

Page 116: ...tain the emergency access user name from your ultrasound system administrator 1 Enter the emergency access user name on the log in screen 2 Click OK The ultrasound system enables limited access to patient data Change your password Available only when enabled for the currently logged in user account in the system configuration menu 1 Click Security 2 Select Change Password 3 Enter the password info...

Page 117: ...formation for a new patient 1 If necessary click New Patient on the patient registration form 2 Enter the required information in the form Edit information in the patient registration form during an active examination 1 Click Correct on the patient registration form 2 Enter or edit the required information in the form Access data for an existing or preregistered patient 1 In the patient registrati...

Page 118: ...d patient Pre register a patient store patient data in the Scheduler 1 Enter the required information in the patient registration form Note You must enter at least the patient s last name an identification code for the patient and date of birth to pre register a patient 2 Click Preregister The system stores the entered registration data in the Scheduler and clears the entries in the patient regist...

Page 119: ...t study type during imaging Select a workflow protocol during patient registration Select a protocol from the Protocol list on the patient registration form The system activates the first view of the protocol when you begin the examination Start a study using the entered registration data Click Start Study Start a new study for the current patient Click New Study The system closes the current stud...

Page 120: ...tient Browser on the toolbar 2 Select Scheduler to display scheduled procedures 3 Select a procedure step and then press SELECT twice Or select a procedure step and then select Register on the Patient menu in the patient browser The system displays the patient information from the selected procedure step in the patient registration form 4 Enter or edit data if required Note The system disables edi...

Page 121: ...ation Append Study Enables addition of new images clips and volumes to an existing study Preregister Pre registers the patient Cancel Deletes any entered patient information and closes the patient registration form Patient Procedure Worklist Selection Description Database Scheduler Available only for studies saved to the ultrasound system hard drive Displays the current database You can select a d...

Page 122: ... or change this value the system calculates and displays the patient s age If a date of birth is not entered before the examination is completed then the system generates the date of birth 11 18 1858 but does not display this date on the form Age The system automatically calculates and displays the patient s age based on the patient s date of birth if entered Sex gender Patient s gender If Male or...

Page 123: ...physician s name Operator Your initials or other identifying code Exam Selection Description Transducer Lists the connected transducers Study Lists the system and user defined exam types Abdomen Abdomen Abdomen New Abdomen New Breast Breast CV Cerebrovascular Digital Digital Adult Echo Adult Echo Fetal Echo Fetal Echo Gyn Gynecology Int op Abd Intraoperative Abdomen Int op Vas Intraoperative Vascu...

Page 124: ...procedure in the imaging service request An imaging service request identifies attributes that are common among the requested procedures Typically generated by an HIS RIS server Accession No Identification code indicating the sequence of the current study as related to other studies for this patient Used for billing purposes Typically generated by an HIS RIS server Note An accession number is requ...

Page 125: ... fetal age in weeks and days the system calculates and displays values for LMP or IVF and EDC No Fetuses If more than one fetus is present enter the number of fetuses up to four to enable the multiple gestation analysis capability Fetus A B C D Gravida Para Aborta Ectopics Patient s history of pregnancies The entries in these fields are transferred to the patient report but do not display on the i...

Page 126: ...on form Press PATIENT on the control panel For systems without a touch screen press Patient Registration on the keyboard Or click Patient Registration The system displays the patient registration form for the current patient 2 Click Correct 3 Update your entries 4 To save the changes click OK 5 To exit the patient registration form without saving changes click Cancel Change the exam type during an...

Page 127: ...ed workflow protocol during an examination Note You must register a patient to select a workflow protocol on the image menu 1 Select the required protocol Select More select eSieScan Protocols and then select a protocol name For systems without a touch screen select a protocol name from the image menu Note The image menu displays eSieScan Workflow Protocols when a workflow protocol has not been se...

Page 128: ...enus and selections display during imaging Example of 2D mode with Doppler and color imaging 1 Color bar 2 Focal point markers 3 Doppler cursor 4 Transducer orientation indicator 5 Doppler gate and Doppler angle indicator 6 Color ROI 7 Doppler Scale 8 Timer 9 Depth 10 CINE bar 11 Doppler baseline 12 Gray bar 13 Doppler spectrum 14 Doppler angle 15 Pulsed wave Doppler gate depth ...

Page 129: ...4 Examination Fundamentals Instructions for Use 4 17 Example of 2D mode with M mode imaging 1 Focal zone markers 2 M mode cursor 3 M mode sweep with depth scale 4 Depth 5 Time scale 6 Heart rate ...

Page 130: ...en For systems without a touch screen press PRIORITY The image menu and the trackball status area indicate the current priority mode 2D Mode Overview 2D mode is the default imaging mode for the ultrasound system It indicates brightness or two dimensional 2D gray scale imaging You can display dual 2D mode images select transducer dependent image formats and adjust imaging parameters for the active ...

Page 131: ...streaming is a well known physical phenomenon that can occur while imaging fluid filled cysts Under typical imaging conditions the color flow and Doppler scale and filter settings are set too high to see the low velocity acoustic streaming however physical artifacts may be generated under the following conditions Long ultrasound pulses are repetitively used to image a fluid filled cyst about 1 cen...

Page 132: ...rameters that you can use to optimize images Some parameters such as depth gain focus and zoom are changed using the controls on the control panel Other parameters such as edge enhancement maps and tint are adjusted using on screen controls The system provides pre defined image optimization presets to accommodate different tissue types The image preset adjusts the settings for a group of imaging p...

Page 133: ...al index TIC 1 0 Cranial thermal index MI 1 2 Mechanical index MIF 0 02 Displayed only when contrast agent imaging is activated Maximum of the mechanical indices measured at the active focal zones 16fps Frame rate 2D mode Settings Example Parameter 2D 100 Imaging mode transmit power THI Submode THI indicates tissue harmonic imaging GEN indicates fundamental imaging Contrast indicates contrast agen...

Page 134: ...hancement EI Map 2 Gray scale or color map for elasticity imaging SW Velocity Elasticity Image display setting applied to shear wave velocity and elasticity data in the region of interest available only for Virtual Touch IQ Color Settings Example Parameter CDV Color mode for example Color Doppler Velocity CDV or Color Doppler Energy CDE 7 3 MHz Transmit frequency 2 dB Gen Gain image optimization p...

Page 135: ... 55 Gain dynamic range MapB E1 Map edge enhancement T 2 Tint Working with Mode Specific Menus When you activate an imaging mode the system displays the related settings for the selected mode on the touch screen For systems without a touch screen the system displays the related settings on the left side of the image screen Note Not all settings can be changed using all methods To work with mode spe...

Page 136: ...ENU to confirm the setting Adjust a setting using the trackball Note If the trackball is assigned to a tool on the image area of the screen press SELECT to assign the trackball to the pointer function 1 Roll the trackball to position the cursor to the selection on the image menu and then press SELECT 2 Rotate MENU to adjust the setting 3 Press MENU to confirm the setting Modify a group of imaging ...

Page 137: ...e also For more information about measurements and calculations refer to the Features and Applications Reference manual Reviewing Images and Clips You can review images stored during the current examination or previous examinations All of the stored images can be viewed deleted flagged for attention and printed When you activate the review feature the system displays all images stored for the curr...

Page 138: ...an image Press IMAGE For systems without a touch screen press the key assigned to the store function The system creates a thumbnail assigns a number and displays the thumbnail in the thumbnail panel at the bottom of the screen The icon on the upper left of the thumbnail indicates the item referenced by the thumbnail image clip or volume Scroll through thumbnails Click the double arrow icon to disp...

Page 139: ...ackball to position the image in the report and then press SELECT Note Images marked for deletion in imaging or review are not removed from the patient report Delete a thumbnail Note You can select multiple consecutive or non consecutive thumbnails 1 Select a thumbnail from the thumbnail panel 2 Click Delete on the image screen The system places a deletion icon on each marked thumbnail Note If the...

Page 140: ...ly BD R and BD RE disk media Siemens has qualified media only from Panasonic and TDK To record a patient study Prerequisite Power on the DVR before powering on the ultrasound system Otherwise the ultrasound system cannot detect the DVR 1 Ensure formatted media is inserted in the DVR Note Refer to the manufacturer s instructions for information about formatting new media 2 Begin recording Select Re...

Page 141: ...elect Pause or Play For systems without a touch screen press GAIN FREEZE CINE 3 To fast forward or rewind playback Select Fast Forward or Rewind For systems without a touch screen rotate GAIN FREEZE CINE 4 To stop playback Select Exit For systems without a touch screen press DVR F12 5 To select a different title or chapter for playback Rotate Title or Chapter and then select Play For systems witho...

Page 142: ...ured destination device when you end an exam If measured results are deleted from the patient report on the ultrasound system after the measurements are successfully transferred the measurements are not deleted on destination device See also Transferring Reports Measurements and Calculations Chapter B1 Features and Applications Reference To end the current patient examination choose a method Click...

Page 143: ...heaths 5 General Information Sheaths 5 Application Sheaths 5 Disposal Sheaths 5 Gel Pad 6 Preparation for Use 6 Needle Guide Brackets 6 EC 1 Needle Guide Bracket Kit 7 Biopsy Puncture Guideline Function 10 Activating the On screen Guidelines 10 System Biopsy Safeguards 11 Needle Path Verification 12 ...

Page 144: ...5 Transducer Accessories and Biopsy 5 2 Instructions for Use ...

Page 145: ...ing brackets and needle guides compatible with eSieFusion Imaging see Technical Description Appendix A Instructions for Use Accessory Curved Array Linear Array Phased Array Endocavity fourSight 4D Transducer Sheath All All All All All Gel Pad 4C1 6C2 9L4 14L5 4P1 4V1 10V4 Needle Guide Bracket Kits CH4 1 4C1 6C1 HD Needle Guide Bracket Kits C7F2 C5F1 7CF2 Needle Guide Bracket Kits 7CF1 7CF1 Needle ...

Page 146: ... Kits EC 1 EC9 4 Needle Guide Bracket Kits MC9 4 MC9 4 Needle Guide Bracket Kits MC9 4 Disposable Endocavity Needle Guide MC9 4 Needle Guide Bracket Kits EC9 4 Disposable Endocavity Needle Guide EC9 4 Needle Guide Bracket Kits EV 8C4 Disposable Endocavity Needle Guide EV 8C4 Needle Guide Bracket Kit 8C3 HD 8C3 HD Needle Guide Bracket Kit 18L6 HD 18L6 HD ...

Page 147: ...ath remove any powder in the sheath by rinsing with water 1 Remove the packaging and unfold the transducer sheath 2 Apply a water based coupling agent gel to the inside of the sheath and onto the face of the transducer 3 Hold the transducer by the cable relief and unroll the sheath onto the transducer 4 Pull the transducer sheath tightly over the face of the transducer to remove wrinkles 5 Secure ...

Page 148: ... may be higher than indicated in the output display on the system Preparation for Use Before use examine the gel pad for any material flaws Any product showing flaws should not be used Needle Guide Brackets WARNING Percutaneous procedures always involve heightened risk to the patient and to the operator handling biopsy needle guides Clinicians using Siemens recommended biopsy devices under ultraso...

Page 149: ...sed after proper training and after verifying the path of the needle WARNING The needle guide is packaged non sterile Sterilize this product prior to its first use WARNING Ensure that the needle guide is properly cleaned and sterilized before each use to avoid possible patient contamination WARNING Before attaching the needle guide to the transducer place the transducer in a sterile transducer she...

Page 150: ...ransducer sheath 2 Select the correct biopsy guide plate 3 Slide the biopsy guide plate into the biopsy guide cover until the plate locks 4 Engage the biopsy adaptor fixing hook into the biopsy adaptor fixing slot at the tip of the transducer Example of fixing the biopsy bracket assembly to the transducer tip 5 Insert the fixing hook at the other end into the fixing slot in the transducer grip sec...

Page 151: ... guide plate from the biopsy guide cover Disposal Dispose of the needle and the transducer sheath according to local state and regional laws and regulations for biohazardous waste If the biopsy bracket assembly becomes damaged or compromised in any way dispose of it only after sterilizing The assembly is made of polyetherimide resin When disposing of the assembly be sure to comply with all applica...

Page 152: ...V 2D mode with power 2D Doppler 2D Doppler with color 2D M mode 2D Doppler with power 2D mode with color 2D Clarify Should you attempt to activate the biopsy function from an incompatible mode the system displays a message to indicate which corrective action the system will take to allow you to activate the biopsy function Select OK to enter the biopsy function Select Cancel to leave the system as...

Page 153: ... a different acceptable mode or freeze the image When you freeze the image the color of the guidelines change from yellow to white Should you request an action that is not allowed during the biopsy function the system displays a message indicating that the action is not allowed Disconnecting the active transducer while in biopsy causes the system to exit the biopsy function The system displays a m...

Page 154: ...ing of the needle during a biopsy or puncture procedure WARNING Do not use a needle guide if the path of the needle is not accurately indicated by the on screen guidelines The path of the needle must display within the guideline Contact your Siemens service representative if the needle path is not accurately indicated 1 Attach the needle guide to the transducer 2 Connect the transducer to the syst...

Page 155: ...cer 14 Using a Transducer Sheath 14 Using Protective Drapes 14 Electrical Safety Considerations 15 Implantable Devices 15 Defibrillators 15 Punctures or Cracks 16 Electrosurgical Units 16 Exam Considerations 16 Bite Guards 16 Exam Procedures 17 Imaging with the V5Ms Transducer 19 Changing the Imaging Scan Plane V5Ms 20 Temperature Controls and Safeguards V5Ms 21 Managing the Lens Surface Temperatu...

Page 156: ... and Storage 30 Approved Cleaning and Disinfection Agents for the Transesophageal Transducer 30 Cleaning and Disinfecting the Transducer 31 Storing and Handling 34 Service and Repair 34 Preventing Injury and Equipment Damage 35 V5Ms Transducer Technical Description 37 V7M Transducer Technical Description 39 ...

Page 157: ...ansducer Refer to the content of this chapter and to the Safety and Care chapter in the Instructions for Use manual for ultrasound system and transducer related safety information WARNING The leakage current test for transesophageal transducers must be done prior to each use in order to reduce the likelihood of harm to the patient Refer to the manufacturer s instructions included with the tester S...

Page 158: ...s transducer supports the following modes 2D mode M mode Pulsed Wave Doppler Steerable Continuous Wave Doppler Color Doppler Color DTI Pulsed Wave DTI Anatomical M mode Example of the V5Ms transducer 1 Flexible shaft 2 Cable 3 Transducer connector 4 Transducer controls 5 Distal tip contains rotating array 6 Articulating section 7 Depth markings in centimeters ...

Page 159: ...and Friction Brakes are located on the handle of the transducer Example of V5Ms transducer controls 1 Flex Controls Bend the articulating section of the transducer shaft 2 Array Rotation Control Rotates the transducer crystal within the distal tip of the transducer 3 Friction Brakes one on each side of the transducer Locks the flex controls Array Rotation Control V5Ms The array rotation control ro...

Page 160: ...ontrol toward the P marking to move the tip posteriorly Right Left Deflection For right deflection of the distal tip rotate the left right flex control toward the R marking to move the tip right For left deflection of the distal tip rotate the left right flex control toward the L marking to move the tip left Neutral Position To place the distal tip in the neutral position rotate the anterior poste...

Page 161: ...ol Example of V5Ms transducer with locked unlocked icons Brake for Anterior Posterior flex control is in the locked position 1 Anterior Posterior flex control light gray 2 Brake for Anterior Posterior flex control light gray Example of V5Ms transducer without locked unlocked icons Brake for Anterior Posterior flex control is in the unlocked position To lock the anterior posterior deflection positi...

Page 162: ...k gray 2 Brake for Left Right flex control dark gray Example of V5Ms transducer without locked unlocked icons Brake for Left Right flex control is in the unlocked position To lock the left right deflection position of the distal tip Press the raised tactile indicator located on the button of the corresponding brake To unlock a brake Press the flat portion on the button of the corresponding brake ...

Page 163: ...nsducer supports the following modes 2D mode M mode Pulsed Wave Doppler Steerable Continuous Wave Doppler Color Doppler Velocity Color DTI Pulsed Wave DTI Anatomical M mode Example of the V7M transducer 1 Flexible shaft 2 Depth markings in centimeters 3 Transducer controls 4 Transducer connector 5 Cable 6 Distal tip contains rotating array 7 Articulating section ...

Page 164: ...ticulation angle The Array Rotation Control Flex Control and Friction Brake are located on the handle of the transducer Example of V7M transducer articulation controls 1 Array Rotation Control Rotates the transducer crystal within the distal tip of the transducer 2 Flex Control Bends the articulating section of the transducer shaft 3 Friction Brake Lock Indicator Red lock indicator means the frict...

Page 165: ...k the friction brake With the distal tip pointed away from you rotate the metal barrel located on the handle counterclockwise until the friction brake lock indicator changes from red to white Array Rotation Control V7M The array rotation control rotates the transducer crystal within the distal tip of the transducer The position of the array corresponds to the imaging scan plane The scan plane is a...

Page 166: ...s viewed from the handle near the connector cable Example of movement of the V7M transducer flex control as viewed from the handle near the connector cable 1 Array rotation control 90 array rotation angle position indicator 2 Flex control neutral position indicator 3 Flex control lock in the unlocked position 4 V7M handle near the connector cable 1 Flex control 2 Rotate the flex control counterclo...

Page 167: ...l tip could fold over in the esophagus causing possible patient injury Contact your local Siemens representative Prior to First Use Proper precautions reduce risks to the patient and the equipment Review the Safety and Care section Thoroughly understand the features and operation of the transesophageal transducer particularly the use of the flex controls and friction brakes Clean and high level di...

Page 168: ...iemens representative 4 Test the brakes V5Ms only Engage the brakes deflection locking mechanism by pressing each ratchet button The brakes hold the distal tip at the appropriate articulation angle when locked V7M only Engage the brake deflection locking mechanism by rotating the metal barrel located on the handle The brake holds the distal tip at the appropriate articulation angle when locked Usi...

Page 169: ...there is interference Defibrillators WARNING The transesophageal transducer is designed to withstand the effects of defibrillation However disconnect the transducer during defibrillation because a malfunction of the safety controls could otherwise result in electrical burns for the patient The transesophageal transducer is designed to withstand the effects of defibrillation There are no exposed co...

Page 170: ...ion circuits which provide extra protection Electrosurgical units and other operating room devices that do not have isolated outputs can introduce radio frequency electromagnetic fields or currents into the patient The transducer is susceptible to these radio frequencies which can interfere with the 2D mode image and can completely override the color flow image making it useless for diagnostic pur...

Page 171: ...the vocal cord WARNING Always use a bite guard to prevent damage to the transducer from the patient s teeth which could as a result create potential mechanical and electrical hazards for the patient Using a bite guard also protects the patient s teeth Exam Procedures V5Ms To use the V5Ms transducer during a transesophageal echocardiogram 1 Remove dentures if present and place them in a protected a...

Page 172: ...esophagus 5 Place the transducer in the patient s mouth and secure the bite guard into place before further advancing the transducer 6 As necessary adjust the anterior posterior deflection using the flex control Position the transducer for optimal acoustical contact and for viewing the required scan plane 7 When good acoustic contact is made engage the friction brake 8 Rotate the array rotation co...

Page 173: ...on and disinfection prior to each use in order to reduce the likelihood of harm to the patient The V5Ms transducer is selected Click Close During imaging with the transesophageal transducer information displays on the image screen regarding the rotation angle of the transducer array and regarding an indication of temperature at the lens surface of the transducer array Lens Temp 37 C The Scan Plane...

Page 174: ...updates to indicate the relative direction of the array and the numerical value of the rotation angle The angle of 0 is equivalent to the transverse imaging scan plane The angle of 90 is equivalent to the longitudinal imaging scan plane The angle of 180 provides the mirrored transverse imaging scan plane Lens Temp 37 C Lens Temp 37 C Lens Temp 37 C Examples of the scan plane icon The array rotatio...

Page 175: ...f mechanism in the interest of patient safety in the unlikely event overheating should occur For additional information on temperature limitation refer to EN 60601 2 37 and IEC 60601 2 37 A temperature sensor mounted in the distal tip of the transducer monitors the temperature of the scanning array and displays the temperature on the screen When the temperature is 37 C or below the temperature ind...

Page 176: ...educe the acoustic output Note You can click Override and continue to scan the patient when the temperature indicator displays 41 C or higher without lowering the acoustic output If the acoustic output is not reduced the lens surface of the transducer array may reach 43 C during imaging If this happens the system automatically freezes the image and turns off the transmitted power to the transducer...

Page 177: ...ature sensor can burn the patient s esophagus Contact your Siemens service representative Follow the instructions included in the on screen message if the system detects a temperature monitor failure Message Displays When Recommended Action Temperature Monitor Failure Temperature monitor failure Disconnect transducer The system detects a temperature sensor failure 1 Click Close to remove the messa...

Page 178: ...r s manual for safety leakage current testing proper use inspection and disinfection prior to each use in order to reduce the likelihood of harm to the patient Estimated Patient Temperature Normal Hyperthermic Note Normal is the default setting The V7M transducer is selected From the list box in the on screen message 1 Select the estimated patient temperature setting If the patient temperature is ...

Page 179: ... The V7M transducer scan plane is adjustable within the range of 12 to 192 The angle indicator in the scan plan icon does not display when the angle is less than 0 1 to 12 or greater than 180 181 to 192 The angle of 0 is equivalent to the transverse imaging scan plane The angle of 90 is equivalent to the longitudinal imaging scan plane The angle of 180 provides the mirrored transverse imaging scan...

Page 180: ...s between 37 0 C and 37 9 C there is a risk the transducer will exceed the maximum thermal limit Above the maximum thermal limit the transducer can burn the patient s esophagus Reduce the transmit power to minimize the possibility of exceeding the maximum thermal limit WARNING The V7M transducer is not intended for use in patients whose core temperature is below 37 0 C If the core temperature of t...

Page 181: ... mechanism in the interest of patient safety in the unlikely event overheating should occur For additional information on temperature limitation refer to EN 60601 2 37 and IEC 60601 2 37 A temperature sensor mounted in the distal tip of the transducer monitors the temperature of the scanning array and displays the temperature on the screen When the temperature is 37 C or below the temperature indi...

Page 182: ...nt has returned to 37 9 C or less Thermal Limit At thermal limit Acoustic output setting reduced System frozen Press Override to continue The lens surface temperature reaches 41 C the thermal limit Click Override Note If you are using the Normal patient temperature setting for a hyperthermic patient change the estimated patient temperature setting to Hyperthermic to prevent the system from prematu...

Page 183: ...ature sensor can burn the patient s esophagus Contact your Siemens service representative Follow the instructions included in the on screen message if the system detects a temperature monitor failure Message Displays When Recommended Action Temperature Monitor Failure Temperature monitor failure Disconnect transducer The system detects a temperature sensor failure 1 Click Close to remove the messa...

Page 184: ...and cleaning methods listed are recommended by Siemens for compatibility with product materials not for biological effectiveness Refer to disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses WARNING Refer to the disinfectant manufacturer s instructions for guidance on proper rinsing of the disinfectant from the transesophageal transducer Any disinfect...

Page 185: ... invalidate the manufacturer s warranty and could increase leakage current Caution The distal tip is very sensitive to pressure Care must be taken not to damage the tip while cleaning it Caution Do not bend the flexible shaft into a curve of less than 30 5 cm in diameter Caution The transducers have been designed and tested to be able to withstand high level disinfection as recommended by the manu...

Page 186: ...cleaners refer to p 6 30 V7M only Clean the distal tip and flexible shaft with gauze pads soaked in mild soapy lukewarm tap water below 26 C 4 Use clean gauze pads to wipe the parts of the transducer that cannot be immersed including the cable handle articulation controls and connector Avoid touching the electrical components on the connector V5Ms only Dip gauze pads in a mild soapy solution V7M o...

Page 187: ...n controls dry while immersing the transducer in an approved disinfectant to the level indicated V5Ms only Do not immerse the transducer more than 100 cm above the distal tip V7M only Do not immerse the transducer more than 70 cm above the distal tip Do not immerse the transducer in the disinfectant agent for more than one hour See also For a list of approved disinfectants refer to p 6 30 2 Carefu...

Page 188: ...d transducer in the original shipping case only after disinfecting The transesophageal transducer is fragile and should not be stored in the transducer holders on the system Transporting the Transducer Use the case for shipping or for moving the transducer from one site to another Take care that the distal tip is straight and that the cable is free of kinks as you carefully place the transducer in...

Page 189: ...lectrical damage leakage current Severe trauma esophageal cuts bleeding perforation electrical burns serious electrical hazards Use only isolated output electrosurgical units with the transesophageal transducer Disconnect the transducer when it is not in use Non isolated electrosurgical units Electrical burns Adjust the Transmit Voltage dB or as low as clinically useful Observe the on screen tempe...

Page 190: ...ite guard and transesophageal transducer Burns in the mouth and esophagus Never use Steam Heat or Ethylene Oxide for disinfecting the transesophageal transducer Do not use any disinfectants other than those specified Do not use iodine or solutions containing iodine for cleaning or disinfecting the transesophageal transducer Improper cleaning resulting in electrical damage Esophageal burns Immerse ...

Page 191: ...ave DTI 3 5 MHz 3 75 MHz 4 0 MHz Imaging Modes 2D mode PW Doppler Steerable CW Doppler Color mode M mode Color DTI Pulsed Wave DTI Anatomical M mode Maximum Image Field of View 90 Image Sector Operating Environment Temperature Relative Humidity 10 C to 40 C 10 to 80 Storage Environment Temperature Relative Humidity 10 C to 50 C 10 to 95 Degree of protection against electrical shock V5Ms transducer...

Page 192: ...lose proximity to sources of electromagnetic fields such as radio transmitters may lead to temporary degradation or interference visible on the image monitor screen A lightening of image background may be noticed while visualizing hypoechoic structures or color spectral interference or jitter or horizontal lines in the image screen may occur The transducer and system have been designed and tested ...

Page 193: ...TI 3 5 MHz 3 75 MHz 4 0 MHz 4 75 MHz Doppler Transmit Frequencies including PW SCW Aux CW Pulsed Wave DTI 3 5 MHz 3 75 MHz 4 0 MHz Imaging Modes 2D mode PW Doppler Steerable CW Doppler Color mode Color DTI Pulsed Wave DTI M mode Anatomical M mode Maximum Image Field of View 90 Image Sector Operating Environment Temperature Relative Humidity 0 C to 45 C 10 to 95 Storage Environment Temperature Rela...

Page 194: ... close proximity to sources of electromagnetic fields such as radio transmitters may lead to temporary degradation or interference visible on the image monitor screen A lightening of image background may be noticed while visualizing hypoechoic structures or color spectral interference or jitter or horizontal lines in the image screen may occur The transducer and system have been designed and teste...

Page 195: ...Instructions for Use 7 1 7 Specialty Transducers 9EVF4 Transducer 3 Transducer Markings 3 Imaging with the 9EVF4 Transducer 4 Technical Data 5 ...

Page 196: ...7 Specialty Transducers 7 2 Instructions for Use ...

Page 197: ...The 9EVF4 transducer is a fourSight 4D curved array transducer The 9EVF4 transducer is designed for endovaginal imaging of the general pelvic region such as during the early stages of pregnancy for detection of ectopic pregnancies and for examination of the follicles ovaries fallopian tubes inner cavities bladder and uterus Transducer Markings The 9EVF4 transducer is designed with an orientation i...

Page 198: ...eering angle is greater or less than 0 Example of the on screen symbol for the 9EVF4 transducer during 2D mode imaging Example of the on screen symbol for the 9EVF4 transducer during volume acquisition Note During fourSight imaging or 3 Scape imaging when using Auto Sweep the range of settings depends on the selected angle Select a scan angle to determine the amount of data for volume acquisition ...

Page 199: ...THI 5 0 MHz 7 0 MHz 9 0 MHz Focus 24 mm 10 Minimum Depth 3 cm Maximum Depth 16 cm Operating modes 2D mode M mode 2D M mode 2D Doppler Color Power Pulsed Doppler Maximum displayable field of view 173 Maximum scan angle wobble angle 90 Radius of Curvature 13 mm Orientation On screen graphical icon indicates steering angle Operating environment 20 C to 40 C Storage 5 C to 50 C Humidity Up to 80 relat...

Page 200: ...7 Specialty Transducers 7 6 Instructions for Use ...

Page 201: ...Instructions for Use 8 1 8 Physiologic Function Physiologic Function 3 Activating the ECG Feature 4 ECG Troubleshooting Guide 6 ...

Page 202: ...8 Physiologic Function 8 2 Instructions for Use ...

Page 203: ...ECG connector Always grasp the connector housing The Physio module consists of the ECG feature The ECG feature includes three leads attached to a six pin ECG cable along with a start up kit of ECG electrode patches The electrical activity controlling the heart muscle is detected by placing ECG electrode patches in specific locations on the patient and amplifying the electrical signals that produce...

Page 204: ...t each lead to the appropriate patch The ECG trace is activated when you connect the ECG cable Note The system cannot display a trace unless all three leads are connected to a patient 4 To dismiss the message that displays when an ECG lead becomes disconnected click Close Or reconnect the disconnected ECG lead In keeping with existing international standards the ECG leads for systems that operate ...

Page 205: ... For systems without a touch screen select Increase Gain or Decrease Gain on the image menu Increase Gain Decrease Gain Position the trace up or down on the image screen Reposition the trace Rotate Position to select Position Min or Position Max Position For systems without a touch screen select Move ECG Up or Move ECG Down Move ECG Up Move ECG Down Adjust the scrolling speed of the trace Availabl...

Page 206: ...elay and then rotate Menu 2 Set a trigger delay for Trigger 2 Rotate the second Delay control For systems without a touch screen select Delay and then rotate Menu Each trigger delay setting determines the position of the related trigger The system retains the trigger delay setting s until the system is powered off Note Increasing the trigger delay positions the trigger farther to the right of the ...

Page 207: ...15 Planning Data 17 Image Alignment 21 Adjusting the Image Alignment 22 Troubleshooting 24 Setting up the Tracking System for eSieFusion Imaging 25 Connecting the Electronics Unit to the Ultrasound System 25 Connecting the Transmitter 26 Repositioning the Transmitter 26 Attaching the Sensors to the Electronics Unit 27 Attaching Sensors to the Transducer or Needle 27 Troubleshooting the Tracking Sy...

Page 208: ...9 eSieFusion Imaging 9 2 Instructions for Use ...

Page 209: ...r alignment eSieFusion imaging enables viewing of a real time ultrasound image aligned with reference data acquired using another imaging modality such as computed tomography CT or magnetic resonance imaging MRI You can use the blended image for visualization during diagnostic ultrasound exams ultrasound guided ablation procedures and ultrasound guided biopsy procedures The eSieFusion feature is c...

Page 210: ...Fusion screen during real time imaging 1 Blended image 2 Tracking quality indicator 3 Orientation indicator 4 Navigator For systems without a touch screen the system displays the eSieFusion menu selections on the left side of the image screen above the Navigator ...

Page 211: ...ruction MPR A rendered view of a single plane axial sagittal or coronal of a volume Navigator A list of all planning data and alignments needle path A guideline drawn on the reference data for use during an interventional procedure planning data Landmarks segmentations and needle paths created for use as references during an interventional procedure reference data A previously acquired data set fo...

Page 212: ...r and then select a compatible transducer and exam type before activating eSieFusion 1 Select the control assigned to activating the feature Select More and then select eSie Fusion For systems without a touch screen click eSie Fusion on the image menu The ultrasound system displays a message while the tracking system initializes and then activates real time imaging and displays selections for eSie...

Page 213: ...s the width of the indicator when tracking quality is high If the indicator displays a yellow bar move the transmitter closer to the patient The system displays a message if the transducer or needle is not detected Sensor 1 Unplugged Needle Unplugged Example of the tracking quality indicators 1 Tracking quality indicator for the transducer sensor 2 The port number on the tracking system for the ac...

Page 214: ...ct and register the patient if necessary 2 Activate eSieFusion 3 Double click the series for the reference data to load When the data is loaded the system closes the patient browser and displays the reference data on the image screen eSieFusion Functions eSieFusion provides tools for the following primary functions Function Description Real time imaging Use the Scan tools to acquire images optimiz...

Page 215: ...sponding on screen marker Example of eSieFusion Navigator 1 Menu to limit the list of entries displayed in the Navigator 2 List of entries 3 Controls to display hide or delete planning data or alignments on the image 4 Entry marker 5 Check boxes to select the entries to hide display or delete eSieFusion Navigator Controls Type of Planning Data Example of Navigator Label Example Marker on the Image...

Page 216: ...en click Hide The system removes the markers on the image for the selected entries To redisplay hidden planning data select the check boxes for the required entries and then click Show Limit the list of entries in the Navigator 1 Click the current Filter Navigator List selection and then select the entries to include in the Navigator Show All displays all entries for planning data and alignments S...

Page 217: ...MPR in the upper left quadrant the coronal MPR in the upper right quadrant the axial transversal MPR in the lower left quadrant and a volume rendering in the lower right quadrant This layout does not support biopsy Measure a distance Available only for 2D images during real time imaging or planning Note The measurement units setting in system configuration does not apply to eSieFusion The system a...

Page 218: ...nd adjust the size or position of the color region of interest C ROI 1 Press C and then select the color region of interest 2 Select Size or Position 3 Roll the trackball to resize or reposition the C ROI 4 Press SELECT Deactivate color imaging Press 2D To exit eSieFusion press 2D again Change the image orientation To change the direction of the image horizontally right to left or left to right Se...

Page 219: ...een select a Window setting on the image menu Adjust the midpoint of values displayed in the reference data Available only during planning Note If the volume quadrant is selected the system applies the setting to the volume data If an MPR quadrant is selected the system applies the setting to all MPRs Select the value setting Drag the Window and Level icon on the touch screen to adjust the setting...

Page 220: ...reen click Scan on the image menu If you have not loaded reference data the system displays a real time ultrasound image in full screen display format If reference data has been fused with the ultrasound image the system displays the blended image Supported Imaging Functionality During real time imaging eSieFusion supports 2D imaging features including CINE and the following imaging functionality ...

Page 221: ...requisite You must connect a needle tracking sensor to port 4 on the tracking system and a transducer sensor to the port associated with the active transducer See also Attaching the Sensors to the Electronics Unit p 9 27 1 Select Scan to display the blended image 2 To view both the reference image and the ultrasound image select the required display format 1 1 2 1 or 1 3 The system displays the re...

Page 222: ...position of the needle solid line 2 Indicates 5 mm on each side of the position of the needle dotted line 3 Indicates that the needle tip position is outside the image plane The system displays a graphical indicator of tracking quality for the transducer sensor and the needle tracking sensor 5 Use the pan function to view the entire needle path in selected display formats See also Quality Indicato...

Page 223: ...erest You can also draw planned needle paths for use during an interventional procedure An on screen indicator identifies the orientation of the patient The system displays the orientation indicator whenever reference data is displayed Label Description A Anterior P Posterior R Right L Left H Head F Feet Example of the on screen orientation indicator ...

Page 224: ... to select a full screen 1 1 or quadrant 4 1 display format Display multiplanar reconstruction MPR with or without a volume rendering VR Available only for a 4 1 display format Select a display setting for the volume Select MPR VR and then select MPR VR or MPR Only For systems without a touch screen select MPR VR or MPR Only Note When you select MPR Only the volume quadrant displays only the plann...

Page 225: ...re the previous display select Reset Display Change the active plane view Select a plane Rotate X Y or Z to select the coronal sagittal or axial view respectively For systems without a touch screen rotate the scroll wheel to rotate the selected plane 3 Identify an area of interest To Do this Identify an area of interest by drawing a line a Activate the drawing tool Select Line Segmentation For sys...

Page 226: ...out a touch screen press NEXT to select Background and then click the required location s on the image e To remove foreground or background seeds Select Clear Foreground Seeds or Clear Background Seeds For systems without a touch screen click Clear Foreground Seeds or Clear Background Seeds on the image menu and then press UPDATE The system displays an outline around the area identified by the for...

Page 227: ...system displays the blended image Proceed to step 2 to reinitialize the alignment or follow the procedures for performing fine adjustments 2 Select Reset Alignment 3 Select Supine or Prone 4 Select Coronal Sagittal or Axial 5 Select Manual to drag and drop the image Or select Point to set a point first on the ultrasound image and then scroll on the reference image to select the second point 6 To i...

Page 228: ...t click Save Alignment The system updates the Navigator with an entry for the saved alignment Manually align the ultrasound image with the reference data 1 Select a setting Select Manual For systems without a touch screen press PRIORITY to select Manual 2 Select the method of manual alignment Select Move Z or Y For systems without a touch screen press NEXT to select Move Z or Y The system changes ...

Page 229: ...on the reference data When you position the pointer on the ultrasound image the system displays a bull s eye marker at the corresponding position on the reference data 4 Repeat steps 2 and 3 to position additional pairs of corresponding points on the reference data and the ultrasound image The system recalculates the optimal alignment of all corresponding pairs each time you position a pair of cor...

Page 230: ...t 4 on the electronics unit No data is displayed Transmitter or sensor is disconnected or the connection is faulty Verify that the transmitter and sensor cables are securely connected to the electronics unit Data is too noisy for example random changes in the position and orientation of the tracking data Excessive electrical noise from other electrical and magnetic devices is interfering with the ...

Page 231: ...alled by an authorized Siemens representative or by a Siemens approved third party The electronics unit must be connected to a USB port on the input output panel of the ultrasound system See also Input Output Panel Connections System Setup Chapter 3 Instructions for Use Example of the trakSTAR2 electronics unit back view 1 RS 232 connection not used 2 Multi unit synchronization connection not used...

Page 232: ...unit When the mid range transmitter is mounted on a rolling stand it is designed to be mobile When the transmitter is in use be sure to engage the brakes located on two of the wheels You can also adjust the height of the transmitter by repositioning the arm on the rolling stand To adjust the position of the transmitter on the transmitter stand 1 Support the arm with one hand and rotate the knob co...

Page 233: ...ional and the transmitter is not activated The LED displays solid green when the tracking system is fully functional and the transmitter is activated Symptom Possible Cause Recommend Action Front panel LED is not illuminated No power Check the power cord connection to the electronics unit and to the power source outlet Cycle power to the electronics unit Front panel LED blinks red and yellow A val...

Page 234: ...ny way the component should be replaced after proper disposal Cleaning and Disinfecting the Tracking System Equipment WARNING To avoid electrical shock and damage to the ultrasound system power off and unplug the equipment from the AC power outlet before cleaning and disinfecting Follow this procedure to clean the tracking system equipment electronics unit transmitter and cables To clean the track...

Page 235: ...tification Measurements 8 Virtual Touch Quantification Patient Report 10 Virtual Touch Quantification Scanning Technique Hints 12 Scanning Techniques to Mitigate Technical Limitations of Virtual Touch Quantification 12 Shear Wave Velocity and Elasticity Measurements in Liver Assessment 14 Virtual Touch IQ 15 Virtual Touch IQ Measurements 19 Virtual Touch IQ Patient Report 21 Virtual Touch IQ Techn...

Page 236: ...10 Virtual Touch Applications 10 2 Instructions for Use ...

Page 237: ...ithin a selected region of interest compared to surrounding tissue The system can also provide a quantitative measurement of shear velocity Vs or elasticity E at a specific anatomical location During acquisition ARFI technology combines a period of pulse sequences with a temporary freeze period of no transmit power A timer indicates the remaining time in seconds until the transducer is available f...

Page 238: ...HD abdominal exam To activate Virtual Touch imaging 1 During 2D mode or 2D mode with THI active select the control assigned to activating the feature Press E and then select Virtual Touch Imaging if necessary For systems without a touch screen select Virtual Touch Imaging Virtual Touch imaging button The system activates a dual display format with a region of interest ROI box on the left image The...

Page 239: ... include the Virtual Touch imaging acquisition Reactivate Virtual Touch imaging after the automatic freeze period ends 1 Unfreeze the image 2 Adjust the ROI size and position if necessary 3 Press UPDATE to begin acquisition Activate dual display 1 Activate a dual format Select Dual For systems without a touch screen double click UPDATE 2 Press UPDATE Select a different color map Rotate VTI Map Exi...

Page 240: ...m 9L4 breast or thyroid exam 6C1 HD abdominal exam Use the system configuration menu to display shear wave measurements as velocity m s or elasticity kPa units in the image screen and patient report System Config System wide Meas Tools Shear Wave Measurements Units To activate Virtual Touch quantification During 2D mode or 2D mode with THI active select the control assigned to activating the featu...

Page 241: ...sured results During system freeze a cooling timer indicates the remaining time in seconds until the transducer is available for image acquisition Note If the system displays the measurement values as x xx the confidence interval threshold for measurement quality was not reached Repeat the acquisition until the system displays a numerical value instead of x xx The system also activates CINE The la...

Page 242: ... and the total number of all measurements assigned to each liver assessment measurement label A valid measurement is any measurement that displays a numerical value in the measured results Lesion 1 8 Valid 10 Total Example of Virtual Touch quantification measurement counter To label then measure shear velocity or elasticity 1 Display the liver assessment measurement labels Select Liver Assessment ...

Page 243: ...o the abdomen patient report Press SELECT Perform another measurement with the current label After the automatic freeze period ends unfreeze the image and then press UPDATE Perform another measurement with a different measurement label 1 After the automatic freeze period ends unfreeze the image 2 Select a label Select Measurement and then select the required label from the list For systems without...

Page 244: ...tile range to the median calculation for all measurements associated with the assigned label Overall Statistics Median Median calculation for all measurements included in the report Mean Mean calculation for all measurements included in the report Std Dev Standard deviation calculation for all measurements included in the report IQR Interquartile range calculation for all measurements included in ...

Page 245: ...nd depth measurements associated with the selected labels 3 Mean median standard deviation interquartile range and the ratio of the interquartile range to the median calculation for all measurements associated with the assigned label 4 Overall mean median standard deviation interquartile range and the ratio of the interquartile range to the median calculation for all measurements included in the r...

Page 246: ... shear wave velocity and elasticity measurements Siemens recommends maintaining a measurement region of interest ROI depth between 3 cm and 6 cm to minimize the effects of depth on shear wave velocity and elasticity measurements To obtain reliable and repeatable results with Virtual Touch quantification apply the appropriate amount of scanning pressure Siemens recommends using minimal to mild comp...

Page 247: ...lat scanning surface 1 90 degree transducer angle 2 60 degree transducer angle Transducer angle on a flat surface Maintain adequate contact and be aware of the effects of the transducer angle relative to the contact surface When the transducer surface is in continuous contact with the skin surface and follows the contour of the curved surface shear wave velocity and elasticity measurements are acc...

Page 248: ...rements using Virtual Touch quantification in liver assessment are reliable Measurements are most reliable at least 1 cm to 2 cm deep to the liver capsule using the intercostal scanning approach along a mid axial line in liver segments 5 and or 8 The patient should breathe normally with measurements taken after the patient is asked to momentarily suspend respiration Multiple measurements in the sa...

Page 249: ...e indexes intended only for the purpose of comparison with other measurements performed using the ACUSON S2000 ultrasound system and the ACUSON S3000 ultrasound system Absolute values for shear wave velocity and elasticity measurements may vary among different manufacturers due to multiple system dependent factors including shear wave frequency excitation beam push beam frequency shear wave detect...

Page 250: ...esults Note If the shear wave velocity and elasticity within the region of interest is not detectable for example a fluid filled cyst or the shear wave velocity and elasticity is non determinant the selected image display setting except quality displays only the 2D mode data in that area no color is displayed Basic measurements including area ratio and distance ratio are also available You can per...

Page 251: ...not detected within the ROI or if you perform a measurement outside of the ROI 3 Measurement counter 4 Measurement marker with unique identifier Each measurement displays the corresponding identifier in the measured results 5 Color bar depicts the range of values displayed in the region of interest for the selected image display setting velocity or elasticity quality time or displacement Note For ...

Page 252: ...ing time in seconds until the transducer is available for image acquisition Change the image display setting Rotate Shear Wave to select the required setting Velocity depicts the range of shear wave velocity or elasticity values from minimum to maximum Shear wave velocity is slower in soft tissue and faster in stiff tissue Elasticity is higher in soft tissue and lower in stiff tissue The color bar...

Page 253: ... Shear Wave setting is Velocity 1 Activate the measurement function if necessary and select the shear velocity measurement tool Press CALIPER and then select Shear Velocity or Elasticity For systems without a touch screen press CALCS and then click Shear Velocity or Elasticity on the measurement menu Note When you use the label then measure method the system automatically activates the shear veloc...

Page 254: ...egion of interest and the color or gray bar to depict the velocities within the selected range The selected maximum and minimum velocity values display above and below the gray bar or color bar The selected maximum and minimum elasticity values display in blue Activate the shadow function in a dual screen format 1 When the measurement function is active select Shadow 2 Perform a measurement on eit...

Page 255: ...e range the distance between the 75th percentile and the 25th percentile for all measurements associated with the assigned label IQR Median Ratio of the interquartile range to the median calculation for all measurements associated with the assigned label Overall Statistics Median Median calculation for all measurements included in the report Mean Mean calculation for all measurements included in t...

Page 256: ... orange red shear wave velocities cannot be estimated and the Velocity or Elasticity Time and Displacement maps display only 2D mode information The following illustration depicts the use of color to represent shear wave quality The color indications in the Quality map help identify locations in the Velocity map where shear wave velocity and elasticity estimations are reliable may be unreliable or...

Page 257: ...in shear wave amplitude can occur The Displacement map indicates the relative differences of shear wave magnitude in the image and are represented in shades of blue The lightest blue represents the highest relative displacement magnitude Shear wave displacement is typically lower in very stiff tissue compared to softer tissues You can correlate the Displacement map to the Quality map to understand...

Page 258: ...10 Virtual Touch Applications 10 24 Instructions for Use ...

Page 259: ... 7 Pulsed Wave Doppler Features 8 Steerable Continuous Wave Doppler 8 Continuous Wave Doppler Auxiliary CW 9 Color Doppler Velocity CDV Features 9 Color Doppler Energy CDE Features 9 M Mode Features 10 Tissue Harmonic Imaging 10 Clips 11 eSieScan Workflow Protocols 11 Accessories and Options 12 Language Specific Operating System 12 Options 13 Transducer Options 26 Digital Documentation Devices 28 ...

Page 260: ...Clinical Measurements Range and Accuracy 36 System Requirements 37 Power Supply Requirements 37 Possible Combinations with Other Equipment 37 Leakage Currents 37 Audio Video and Data Transmission Connections Input and Output Signals 38 Wireless Network Connections 39 Environmental Requirements 40 Protective Measures 40 Maximum Physical Dimensions 40 System Classifications 41 Standards Compliance 4...

Page 261: ... DICOM communication transferred from the system to a DICOM compatible device Note The available features depend on the licenses purchased for your system Operator Control Panel Task lighting and backlit controls and keys Control panel height adjustment for standing and sitting positions Left right swivel 38 Range of height 85 cm to 100 cm Control panel text in English German French Spanish or Ita...

Page 262: ...wivel 180 Extended wide angle viewing angle rotation at the base of the monitor 178 Tilt front 90 and back 10 Articulating arm adjustments independent of control panel Left and right swivel 180 Vertical up to 12 7 cm Mobility The Mobile QuikStart feature for portable studies decreases the time required to power the system on or off by using the installed battery to place the ultrasound system in a...

Page 263: ...lity Three array transducer ports One auxiliary continuous wave transducer port Parking port for transducer storage Transducer holder for all transducer designs and gel bottle storage Micro pinless connectors Electronic transducer selection Lightweight ergonomic transducer design with SuppleFlex cables Image depth maximum Transducer Maximum Display Depth cm 4C1 30 6C1 HD 30 6C2 30 8C3 HD 30 7CF1 2...

Page 264: ...bination drive does not support DVD R or DVD RW formatted media Recordable disk DVD drive and hardware for storage review and archival of patient and image data Disk Media Caution Use only disk media brands that have been qualified by Siemens You may have problems saving data to or retrieving data from disk media that has not been qualified by Siemens Only use CD Rs recordable compact disks or DVD...

Page 265: ...fication in frozen CINE or real time imaging 0 5 cm to 30 cm depth of view display CINE memory capacity Up to 30 seconds of CINE capture Acquired 2D mode frame rates up to 500 fps Up to six 2D mode transmit frequencies per transducer Quad signal parallel processing Linear array transducer beam steering 2D Doppler Refresh Update and Triplex functions Gain of 20 dB to 20 dB in one decibel increments...

Page 266: ... maps Spectral invert User selectable frequency kHz or velocity m s display format Wall filter selections 20 Hz to 1 600 Hz Adjustable Doppler Gate size from 0 1 cm up to 4 0 cm depending on the transducer Flow angle correction on real time or frozen images with velocity readout update PRF range from 100 Hz to 52 000 Hz Doppler signal processing that enables automatic calculation of waveform stati...

Page 267: ...tates low general and high Color adaptive wall filter PRF range of 100 Hz to 19 500 Hz Six color velocity maps three velocity maps and three velocity variance maps VV Up to 512 color samples per color data line Up to 512 2D mode lines plus 256 color lines Color Doppler Energy CDE Features Power mode On Off control Background Power Doppler on and off selection Power Gain from 20 dB to 20 dB in one ...

Page 268: ...ve sweep speed selections Up to five user selectable transmit frequencies Up to four user selectable Edge Enhancement selections Six M mode grayscale maps and up to 12 colorization maps 25 second CINE capability for measurements Anatomical M mode for cardiac exams supports visualization of an M mode sweep by rotating the M mode cursor off axis Tissue Harmonic Imaging Available for all imaging tran...

Page 269: ...rts storing of individual images within clips eSieScan Workflow Protocols An eSieScan protocol is a pre defined checklist that guides you through a clinical workflow Define protocol steps views that include an image volume or clip with measurements body markers and annotations Change the sequence of views during a protocol Pause and resume a protocol Activate a clinical application program during ...

Page 270: ...service department or your local Siemens representative WARNING You must only use the transducers accessories cables and replacement parts for internal components specified by Siemens to reduce the risk of increased RF radio frequency emissions or decreased immunity of the ultrasound system The Siemens authorized accessories and options for your ultrasound system are listed in this chapter Note To...

Page 271: ...image brightness uniformity by changing the DGC and overall gain Requires the Tissue Equalization TEQ Technology Option Compatible transducer 6C1 HD Supported studies Abdomen Fetal Echo Gyn OB Pelvis Renal Compatible transducer 8C3 HD Supported studies Gyn OB Pediatric Abdomen Fetal Echo Compatible transducer MC9 4 Supported studies Gyn OB Prostate Neonatal Head Compatible transducer 12L4 Supporte...

Page 272: ...ic tissue presentation and patient specific processing that adapts to differences in tissue Clarify Vascular Enhancement Clarify VE Technology Option Available in combination with 2D mode the 2D mode image in Doppler SieClear compounding and THI Clarify vascular enhancement technology Clarify VE is an optional feature that can decrease artifacts in the 2D mode image resulting in an improved view o...

Page 273: ...e 8 mm sensors CIVCO eTrax Needle Sensor Starter Kit Transducer specific tracking brackets without needle guides Transducer specific tracking brackets with needle guides Note For information on the installation care and operation of hardware components refer to the manufacturer s operating instructions that accompanied the device eSie Touch Elasticity Imaging Option Provides a qualitative represen...

Page 274: ...1 Supported studies Abdomen Compatible transducer 4V1 Supported studies Abdomen Compatible transducer 9L4 Supported studies Breast Thyroid Compatible transducer 6C1 HD Supported studies Abdomen Use Virtual Touch quantification to measure tissue shear velocity Vs and elasticity E for a selected region of interest Virtual Touch quantification uses acoustic radiation force impulse ARFI technology of ...

Page 275: ...rement labels for the breast and thyroid exams Supports all basic measurements in either a full screen format or a dual screen format 3 Scape Real Time 3D Imaging Option WARNING To avoid technique related artifacts you must be thoroughly familiar with the techniques of 3D and 4D imaging Read the entire 3D and 4D imaging chapter before using the 3 Scape real time 3D imaging or fourSight 4D ultrasou...

Page 276: ... all spatial dimensions MultiPlanar Rendering demonstrates imaging planes not accessible with normal scanning techniques Amnioscopic Render Method Option Requires the 3 Scape 3D Imaging and Advanced fourSight Technology Options Provides detailed and near photorealistic views of the fetus Fetal Skeletal Rendering Option Requires the 3 Scape 3D Imaging Option Optimizes visualization of the fetal spi...

Page 277: ... reference and speed indicators enhance imaging technique Reverse during acquisition Zoom and pan capabilities Compatible with the Dynamic TCE tissue contrast enhancement technology option Color SieScape Panoramic Imaging Option WARNING To avoid technique related artifacts and measurement inaccuracies read the entire SieScape imaging chapter before using the SieScape feature WARNING To ensure accu...

Page 278: ...en Renal Supports the following acquisition techniques Contrast Pulse Sequencing CPS Agent Detection Imaging ADI CPS is a low Mechanical Index continuous real time non linear imaging technique that provides contrast to tissue specificity ADI is a high Mechanical Index imaging technique that uses the emission properties of contrast agents to characterize their presence or absence in the tissue Supp...

Page 279: ...ation from Bracco The software is used to perform qualitative and quantitative analysis of linear data For information regarding the software application refer to the manufacturer s instructions Multi Modality Review Note Reference images displayed on the ultrasound system are informational only and not intended for diagnosis Displays images from a previous exam side by side with images from the c...

Page 280: ...mber or four chamber view of the heart Generates calculation data and measurements for end diastolic volume and end systolic volume ejection fraction and heart rate syngo Velocity Vector Imaging Option WARNING This application utilizes ultrasound data collected prior to analysis The quality of the data collected and used as input could have an effect on the output of this application Variability i...

Page 281: ...t agent imaging technology Illustrates contrast agent enhancement by displaying graphs indicating changes of intensity over time within defined regions of interest ROIs Measures the average value and curve fitted value for each ROI on each image frame syngo Arterial Health Package AHP Compatible with clips or images that contain only 2D mode data and clips or images acquired with a linear transduc...

Page 282: ... keep the recovery key in a secure location The software option protects the information stored on ultrasound system by preventing unauthorized access Protection of patient information and system settings A USB storage device with the recovery key for recovering encrypted data AcuNav ICE Intracardiac Echo Option Compatible with AcuNav 8F and AcuNav 10F transducers SwiftLink catheter connector incl...

Page 283: ...sue imaging capability Pulsed Wave DTI Doppler tissue imaging capability Continuous Wave Interchangeability Option Enables functionality for auxiliary continuous wave Doppler Virtual Communication for eSieLink Remote Assistance Enables virtual communication for remote assistance with a Siemens representative Requires using the phone number provided by your Siemens representative to initiate remote...

Page 284: ... 8C3 HD Hanafy Lens Transducers Linear Array 9L4 12L4 14L5 14L5 SP 18L6 HD requires a license on the ACUSON S1000 system Transducers Phased Array 4P1 4V1 4V1c 8V3 10V4 V5Ms includes the Leakage Current Tester V7M includes the Leakage Current Tester AcuNav 8F AcuNav 10F Transducers Endocavity EV 8C4 EC9 4 MC9 4 Transducers fourSight 4D Require 3 Scape Real Time 3D Imaging Option 7CF1 7CF2 9EVF4 Tra...

Page 285: ... 2 Needle Guide Set 4V1 SG 3 Needle Guide Set 9L4 SG 4 Needle Guide Set 14L5 SG 5 Needle Guide Set 6C2 VF12 4 Needle Guide Set 12L4 8C3 HD Needle Guide Set 8C3 HD 18L6 HD Needle Guide Set 18L6 HD See also For a list of transducers compatible with the needle guide accessories refer to Chapter 5 in this manual Transducer Accessories eSieFusion Imaging Tracking bracket without needle guides 6C1 HD 4C...

Page 286: ... Black and White Printer Assembly P 93DW Mitsubishi External Black and White Printer Assembly UP 897 Sony External Black and White Printer Assembly UP 898 Sony External Color Printer Assembly UP D23MD Sony External Color Printer Assembly UP D25MD Sony External Color Printer Assembly UP D55MD Sony External Color Printer Assembly CP30DW Mitsubishi Not available for sale Consumables Black and White P...

Page 287: ...a circumference volume stenosis and volume flow Label then Measure or Measure then Label workflow General 2D mode Measurements Distance Depth Circumference using a Trace or Ellipse method Area using an Ellipse or Trace method Volume and Stenosis Volume Flow using an Area or Diameter method with a Doppler measurement General M mode Measurements Distance Depth Heart Rate Slope Time General Doppler M...

Page 288: ... with the assigned label The patient report includes a liver evaluation section that displays shear wave velocity and elasticity measurements from the Virtual Touch quantification function Breast The patient report includes shear wave velocity and elasticity measurements from Virtual Touch IQ Cerebrovascular The patient report includes selections for the Internal Carotid Artery Common Carotid Arte...

Page 289: ...Ellipsoid Right Atrial Volume Area and Length Simpson Single Plane M mode measurement labels include specific labels for Aortic Valve Left Atrium M mode Mitral Valve Right Ventricular Dimensions and Left Ventricular Dimensions M mode calculation labels including Cardiac Index Cardiac Output End Diastolic Velocity and End Systolic Velocity Ejection Fraction Aortic Root Left Atrium Heart Rate Stroke...

Page 290: ...n SD of measurements and EFW Calculations Singleton twin triplet or quadruplets User defined Obstetrical tables User defined fetal and maternal assessment checklist Serial historical growth trending import up to 20 previous exams Export of data with serial cable to Windows file share location using DICOM Structured Reporting Growth Evaluation Ratios Cephalic Index CI HC AC FL AC FL HC FL BPD Left ...

Page 291: ...r in tracing the desired object and assuming 1 540 m sec speed of sound Time Slow Sweep 0 9 4 sec Tol T Slow Sweep 15 msec Time Med Sweep 0 4 7 sec Tol T Med Sweep 7 5 msec Time Fast Sweep 0 2 4 sec Tol T Fast Sweep 3 8 msec Velocity 10 600 cm sec Tol V 10 of the velocity or 5 cm s whichever is greater using a J J A string phantom at 45 degrees 1 degree Also applies to measurements on MPR slice qu...

Page 292: ...aximum Value Velocity 20 600 cm sec V Tol V V Tol V Frequency 2F0Vcosθ 1540 F0 Carrier Frequency 2F0cosθ V Tol V 1540 2F0cosθ V Tol V 1540 Delta Velocity V1 V2 V1 Tol V1 V2 Tol V2 V1 Tol V1 V2 Tol V2 Delta Frequency 2F0cosθ V1 V2 1540 2F0cosθ V1 Tol V1 V2 Tol V2 1540 2F0cosθ V1 Tol V1 V2 Tol V2 1540 Time Slow Sweep 0 11 2 sec T Tol T Slow Sweep T Tol T Slow Sweep Time Med Sweep 0 5 6 sec T Tol T M...

Page 293: ...or Formula Minimum Value Maximum Value Distance 0 24 cm D Tol D D Tol D Time Slow Sweep 0 11 2 sec T Tol T Slow Sweep T Tol T Slow Sweep Time Med Sweep 0 5 6 sec T Tol T Med Sweep T Tol T Med Sweep Time Fast Sweep 0 2 8 sec T Tol T Fast Sweep T Tol T Fast Sweep Heart Rate 60 240 bpm N Time for N beats N Time for N beats Tol T N 1 2 3 4 or 5 N Time for N beats N Time for N beats Tol T N 1 2 3 4 or ...

Page 294: ... the velocity over the depth range of 0 5 2 0 cm Elasticity E 1 9 40 0 kPa Tol E Applies to the 4C1 4V1 and 6C1 HD transducers 20 of the elasticity over the depth range of 0 5 8 0 cm 40 0 75 0 kPa Tol E Applies to the 4C1 4V1 and 6C1 HD transducers 30 of the elasticity over the depth range of 3 0 6 0 cm Elasticity E 1 9 111 6 kPa Tol E Applies to the 9L4 transducer 20 of the elasticity over the de...

Page 295: ...Check with your sales representative WARNING Accessory equipment connected to the analog and digital interfaces must be certified according to the respective EN and IEC standards for example EN 60950 and IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Anyone who connects additional equipment to any of the signal input or signal output ports configures a medical system...

Page 296: ...eo and audio Input USB A J4A J4B J5A J5B Input output panel Printer video recorder remote control eSieFusion electronics unit SIE1 data transmission headset and camera for virtual communication with a Siemens service representative Bi directional DVI J9 Input output panel External monitor digital or analog Output BNC type J13 Input output panel ECG trigger Output USB A Control panel USB storage de...

Page 297: ...system supports the following options for connections to wireless networks Network standard 802 11a 802 11b 802 11g 802 11n Mixed Frequency bandwidth 2 4 GHz 5 GHz Authentication WPA WPA2 WPA PSK WPA2 PSK Open Shared Encryption None WEP TKIP AES Extensible Authentication Protocol EAP PEAPv0 PEAP MSHCAPV2 ...

Page 298: ...xcept 7CF2 9EVF4 10 C to 40 C 10 C to 50 C 7CF2 9EVF4 20 C to 40 C 5 C to 50 C Pencil CW Transducers CW2 CW5 10 C to 40 C 40 C to 60 C Maximum Altitude Operation up to 3 050 meters 10 000 feet 5 050 meters 18 000 feet For systems with documentation devices installed Protective Measures Explosion protection This product is not designed for operation in areas subject to explosion hazards Maximum Phy...

Page 299: ...ensors and needle tracking sensors Type CF applied part for ACUSON AcuNav ultrasound catheters Defibrillation proof applied part for ECG and ACUSON AcuNav ultrasound catheters Degree of protection against harmful ingress of water Ordinary equipment Degree of safety of application in the presence of a flammable anesthetic material with air or with oxygen or nitrous oxide Equipment not suitable for ...

Page 300: ...is in use Note The system is a Class A device when the ACUSON S2000 Automated Breast Volume Scanner is in use Note The ultrasound system is a Class A device when the eSieFusion is in use EN 60601 1 6 and IEC 60601 1 6 EN 60601 2 18 and IEC 60601 2 18 EN 60601 2 37 and IEC 60601 2 37 ISO 14971 Acoustic Output Standards IEC 62359 AIUM NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ult...

Page 301: ... 42 EEC of June 14 1993 concerning Medical Devices The CE marking only applies to medical devices that have been put on the market according to the above referenced Council Directive Unauthorized changes to this product are not covered by the CE marking and the related Declaration of Conformity EU Authorized Representative Siemens Healthcare GmbH Henkestr 127 91052 Erlangen Germany ...

Page 302: ...Appendix A Technical Description A 44 Instructions for Use ...

Page 303: ... Controls 8 2D 2D Mode 8 C Color 8 PW Pulsed Wave Doppler 9 CW Continuous Wave Doppler 9 M M Mode 9 Image Optimization Controls 10 Depth 10 Focus 10 Scale 10 Baseline 11 TEQ 11 DGC Slider Controls 11 Image Format Controls 12 Dual 12 Zoom 12 Annotation and Measurement Controls 13 Annotation 13 Caliper 13 Delete 13 Freeze and Archive Controls 14 Freeze 14 Clip 15 Image 15 Specialty Controls 16 UD Us...

Page 304: ...asticity 18 Contrast 18 Workflow Controls 19 Patient 19 Review 19 Report 19 End Exam 19 Footswitch 20 Alphanumeric Keyboards 20 Retractable Keyboard 20 Touch Screen Keyboard 20 Special Keys 21 Special Keys on the Retractable Keyboard 21 Special Keys on the Touch Screen Keyboard 22 Special Characters 23 ...

Page 305: ... press controls press or rotate controls and a retractable keyboard A trackball provides access to objects on the image screen When the ultrasound system is in use most controls on the control panel and touch screen are supported by context sensitive lighting Exceptions are noted in this chapter Color of Lighting Status Blue The control or selection is in use active White The control or selection ...

Page 306: ...ons 5 Controls correspond to the touch screen selections directly above the controls Press rotate or press and then rotate a control to make a selection or change a setting Symbols on the Touch Screen Symbol Description Indicates a port is available for connecting an array transducer to the system Indicates a port is available for connecting a continuous wave pencil transducer to the system Access...

Page 307: ...CT left side and SELECT R right side controls Note Unless otherwise indicated the SELECT and SELECT R controls have the same functionality Trackball Functions The function of all trackball controls depends on the active task The active functions for trackball controls are indicated by on screen labels displayed at the bottom of the image screen Example of on screen labels indicating the active tra...

Page 308: ...n format or a 2D image and M mode sweep in a split screen format when you double click the control SieScape or 3D imaging Starts pauses or continues the acquisition process eSie Touch Elasticity Imaging Starts the acquisition process and displays either a dual screen format or a full screen format Virtual Touch Imaging Virtual Touch IQ Starts the acquisition process Displays either a dual screen f...

Page 309: ...her object on the image screen Displays the selected thumbnail in review in a full screen format when you double click the control Measurements SELECT anchors a measurement marker and either generates the next marker for positioning or completes the measurement SELECT R activates previous measurement markers for repositioning Review Highlights any type of image or thumbnail on the review screen Sy...

Page 310: ...mode gray scale imaging except during 3D or 4D imaging During zoom restores a magnified image to the original size During system freeze reactivates image acquisition During 3D or 4D displays the 3D or 4D setup screen During 4D cancels acquisition and redisplays the setup selections During stress echo pauses the stress echo protocol C Color Activates or exits Color Doppler Note Use the touch screen...

Page 311: ...g 3D or 4D rotates the selected quadrant around the y axis when you rotate the control CW Continuous Wave Doppler Activates steerable continuous wave SCW Doppler for phased array transducers During 3D or 4D rotates the selected quadrant around the z axis when you rotate the control M M Mode Activates M mode and displays the M mode sweep and 2D image according to the image screen format selected in...

Page 312: ... or decreases depth Steps through the slices during 4D imaging or 3D 4D system freeze when the slice function is available Focus Repositions the focal zone markers on the image Scale Adjusts the scale factor of the Pulsed Repetition Frequency PRF During combined mode imaging affects only the active priority mode ...

Page 313: ...ctivates TEQ Tissue Equalization technology Deactivates TEQ when you double click the control Activates eSieImage Multiparametric Optimization when scanning with a compatible transducer and supported exam See also For information about this feature refer to Appendix A in this manual Disables eSieImage Multiparametric Optimization when you double click the control You can then manually adjust the g...

Page 314: ... Config Basic System Zoom Changes the image magnification zoom when you rotate the control The system displays a Z on the image screen when zoom is activated Activates the zoom function and displays a zoom box for a specific region of interest when you press the control once Activates the high density zoom function with enhanced resolution when you press the control twice The system displays HD on...

Page 315: ...ding text body markers and arrows Caliper Activates or deactivates the measurement function Delete Deletes one word at a time in reverse chronological order Deletes the measurement in progress Deletes a body marker Deletes arrows in reverse chronological order Clears the screen of all text body markers arrows and measurement calipers when you press and hold the control ...

Page 316: ...e Freezes or unfreezes acquisition of an image sweep or spectrum During clip capture ends the capture During data entry closes the form and redisplays the image screen During review activates an assigned function For example exits review or a clinical application program or plays and pauses CINE data Use the system configuration menu to select the function assigned to the freeze function during re...

Page 317: ...he system s hard disk The system displays saved data in the thumbnail panel if enabled Ends clip capture while capturing a clip Starts playing CINE data from the current frame and stores the data from the current location to the end of the clip during system freeze Image Activates the function assigned to this control ...

Page 318: ...r Press the pointer control to enable text entry or access to the controls on the image screen or the thumbnails on the right side of the image screen Note If a tool is activated and the trackball pointer cursor is not visible press POINTER to redisplay the pointer Forward Backward During an eSieScan protocol or a stress echo protocol pauses or resumes the protocol when you press the control Activ...

Page 319: ...rols 3D 4D Activates or deactivates 3D 4D setup depending on the active transducer and exam type Displays the 3D 4D setup screen Adjusts the 3D 4D brightness during system freeze when you rotate the control Adjusts the volume gain during real time imaging when you rotate the control ...

Page 320: ...h IQ Virtual Touch Quantification Virtual Touch Imaging eSie Touch Elasticity Contrast Activates the selected contrast imaging technique and provides access to other contrast imaging techniques Use the system configuration menu to select the contrast clip capture protocol when you activate contrast imaging System Config Basic System 2 ...

Page 321: ...xamination stored in the local database Provides access to clinical software programs syngo Arterial Health Package syngo Velocity Vector Imaging syngo Auto Left Heart syngo Contrast Dynamics Report Opens or closes a patient report End Exam Activates the following functions Ends the exam Closes the current patient study Closes images Saves a report Initiates any actions queued to occur at the end ...

Page 322: ...trol panel To extend the keyboard pull gently on the keyboard To retract the keyboard gently push the keyboard backward toward the ultrasound system Touch Screen Keyboard The system displays a customized alphanumeric keyboard on the touch screen when you use the following forms or functions Patient registration form or report Text annotation System configuration menu The on screen keyboard display...

Page 323: ...ation function is active inserts a blank space at current position of the text cursor Alt Provides access to special characters required for some languages when used in combination with the alphanumeric keys Note This key is labeled Alt Gr on non English keyboards Alt Gr Available only on non English keyboards Accesses special characters located on the alphanumeric keyboard Delete Last Word Delete...

Page 324: ...the Home position press and hold Home for a few seconds Clear Screen Removes all text arrows and body markers from the image screen Delete Line Deletes the line currently containing the cursor or the word most recently entered Hide Words Displays or hides any text added to the image screen The off setting shows text and the on setting hides text Page Displays the next or previous page when availab...

Page 325: ...ter Key Combination Ä Alt p ä Alt ö Alt 0 zero Ü Alt ü Alt ß Alt Ç Alt n ç Alt j à Alt z è Alt x é Alt s ù Alt b Spanish Italian Character Key Combination Character Key Combination Alt 1 Alt Ñ Alt I ñ Alt 9 á Alt a é Alt s í Alt d ó Alt f ú Alt g à Alt z è Alt x é Alt s ì Alt c ò Alt v ù Alt b Scandinavian Other Character Key Combination Character Key Combination Æ Alt m æ Alt k Ø Alt period ø Alt...

Page 326: ...Appendix B Control Panel and Touch Screen B 24 Instructions for Use ...

Page 327: ...Keys 5 UPDATE 6 SELECT 7 PRIORITY 8 NEXT 8 Gain Freeze Cine 9 Imaging Mode Controls 9 Image Optimization Controls 11 Transmit Power 13 Power Lighting Sound and Special Function Controls 13 Other Imaging Controls 13 Archive Controls 14 LED Panel Controls 14 Alphanumeric Keyboard 15 Special Characters 15 Function Keys 16 Other Alphanumeric Keys 17 ...

Page 328: ...Appendix C Control Panel C 2 Instructions for Use ...

Page 329: ...ntrol panel also includes customizable keys Use the system configuration menu to assign the function of the customizable keys System Config Print Store Control Panel Lighting When the ultrasound system is in use most controls on the main control panel are supported by backlighting Exceptions are noted in this chapter Color of Lighting Status Green The control is active in use White The control is ...

Page 330: ... Control Panel Example of the control panel and alphanumeric keyboard on the ultrasound system 1 Power on off 2 Backlighting and task lighting 3 Volume control Microphone on off 4 Transmit power 5 DGC controls 6 Control panel 7 LED panel 8 Alphanumeric keyboard ...

Page 331: ... functions for trackball controls are indicated by on screen labels displayed at the bottom of the screen The active functions for the soft keys and scroll wheel are displayed above the trackball control labels and above the thumbnail panel See also For information about the use of trackball controls during eSieFusion Imaging refer to Chapter 9 in this manual Note The scroll wheel does not support...

Page 332: ...ity Imaging Displays either a dual screen format or a full screen format Virtual Touch Imaging Starts the acquisition process Prior to acquisition double click UPDATE to display either a dual screen format or a full screen format Virtual Touch Quantification Starts the acquisition process Displays the shear velocity measurement in the measured results Virtual Touch IQ Starts the acquisition proces...

Page 333: ... menu activates a menu selection Press SELECT twice to display the selected thumbnail in review in a full screen format Measurement When the cursor is positioned over the image area anchors a measurement caliper and generates the next caliper for positioning When the cursor is positioned over the measurement menu selects a measurement tool for example Distance Volume or Velocity measurement label ...

Page 334: ...e imaging mode tools currently controlled by the trackball For example during Doppler press NEXT to activate the Doppler gate positioning function or the Doppler gate steering function When the trackball is assigned to the pointer function the NEXT key is equivalent to the right mouse button on a personal computer SieScape Activates the rotate function or the pan function Measurement Cycles throug...

Page 335: ...on press GAIN FREEZE CINE to play or pause clip playback or to exit review Use the system configuration menu to select the function assigned to pressing GAIN FREEZE CINE during review System Config Basic System 2 Rotate GAIN FREEZE CINE to view a clip frame by frame Imaging Mode Controls Control Name Active Function Description 2D 2D mode Press 2D to activate 2D mode grayscale imaging except durin...

Page 336: ...or Rotate C to adjust the gain 3D or 4D Rotate X to rotate the selected MPR multi planar reformatting quadrants around the x axis PW Y Pulsed Wave Doppler Press PW to activate the pulsed wave PW Doppler function for linear curved and phased array transducers Rotate PW to adjust the gain 3D or 4D Rotate Y to rotate the selected MPR multi planar reformatting quadrants around the y axis Use the syste...

Page 337: ...when available and does not illuminate when not available Rotate MENU during a protocol to select the PREVIOUS or NEXT control for scrolling the thumbnail panel Press MENU to scroll the thumbnail panel DEPTH Rotate DEPTH to change the imaging depth When the slice function is activated during 3D imaging or during 4D system freeze rotate DEPTH to step through the slices Use the system configuration ...

Page 338: ...all contrast resolution of an image sweep or spectrum BASELINE In combined mode imaging affects only the active priority mode Push BASELINE up or down to adjust the position of the spectral or color baseline This control illuminates white when available and does not illuminate when not available SCALE In combined mode imaging affects only the active priority mode Push SCALE up or down to adjust th...

Page 339: ... to the footswitch pedals System Config Footswitch UD Other Imaging Controls Key Name Description CADENCE Press CADENCE to activate the default contrast imaging modes and provide access to other contrast imaging modes DUAL Press DUAL to activate or deactivate dual imaging During contrast agent imaging the DUAL key activates or deactivates live dual display format Use the system configuration menu ...

Page 340: ...to activate the function assigned to this key STORE Use the system configuration menu to assign print and or store functions to this key System Config Print Store Press STORE to activate the function assigned to this key LED Panel Controls The LED panel provides functions based on the current system state or operating mode Each selection displayed on the LED panel corresponds to the control immedi...

Page 341: ...Key Combination Ä Alt p ä Alt ö Alt 0 zero Ü Alt ü Alt ß Alt Ç Alt n ç Alt j à Alt z è Alt x é Alt s ù Alt b Spanish Italian Character Key Combination Character Key Combination Alt 1 Alt Ñ Alt I ñ Alt 9 á Alt a é Alt s í Alt d ó Alt f ú Alt g à Alt z è Alt x é Alt s ì Alt c ò Alt v ù Alt b Scandinavian Other Character Key Combination Character Key Combination Æ Alt m æ Alt k Ø Alt period ø Alt Å A...

Page 342: ... closes the system configuration menu Use the system configuration menu to modify and customize the system including general settings image annotation and calculation settings Help Opens or closes information about using the ultrasound system Hide Name Hides or displays patient identifying information on the patient banner on the image screen Home Set Home Repositions the text cursor to the predet...

Page 343: ...t during text entry Arrows Repositions the text cursor in the direction shown on the arrow key Enter Positions the cursor at the beginning of the next line of text or field and accepts entered data Tab Positions the cursor to the beginning of the next available entry field in the patient registration form or patient report Caps Lock Locks all keyboard letter keys in upper case Shift Accesses the u...

Page 344: ...his key does not delete arrows or body markers Text Start Space Bar Inserts a blank space when used during text entry Alt Gr Available only on non English keyboards Accesses special characters located on the alphanumeric keyboard Text A Text B Text C Text D System defined annotation keys Places text on the image screen at the cursor location Arrow Up Annotation Displays an annotation arrow Press C...

Page 345: ...ameter Selections 19 Clip Capture Selections 22 CINE Graphics 23 Annotation Selections 23 Basic Measurement Tools 26 2D Measurement Tools 26 Doppler Measurement Tools 27 M Mode Measurement Tools 28 Patient Report Screen Controls 29 Selections for Cardiac Measurements 30 Basic Cardiac Measurement Tools 30 Cardiac Report Controls 31 DVR Menu Selections and Status Indicators 32 Recording Icons 32 Rev...

Page 346: ...nt Browser Screen 41 Icon Selections 41 Menu Selections 42 Patient Menu Selections 42 Transfer Menu Selections 43 Edit Menu Selections 45 View Menu Selections 46 Filter Menu Selections 47 Sort Menu Selections 48 Options Menu Selections 49 Help Menu Selections 49 ...

Page 347: ...nd patient data management Appendix D Advanced imaging features and clinical application programs Appendix E The controls displayed on the screen depend on the currently active imaging mode or function For example a specific set of selections displays during 2D imaging and a different set of selections display during the measurement function Certain controls such as the toolbar or the thumbnail pa...

Page 348: ...creen for the image Security Available only on systems with the security package activated Opens or closes the dialog box for locking the screen on the ultrasound system logging off the system logging in as a different user and changing the user account password Available only on systems without a touch screen Hide or Show Menu Hides or redisplays the menu located on the left side of the screen Pa...

Page 349: ...l displays the stress echo icon marks all stress echo images for deletion Total Indicates the total number of thumbnail images captured for the exam Icon Description Indicates the thumbnail represents an image Indicates the thumbnail represents a clip Indicates the thumbnail represents a volume Indicates the thumbnail represents a 4D volume Indicates the thumbnail represents a 4D clip Indicates th...

Page 350: ...te the microphone Selection Description Blue Light Adjusts the brightness of the blue lighting when a control or selection is in use White Light Adjusts the brightness of the white lighting when a control or selection is available but not in use Keyboard Adjusts the brightness of the backlighting for the retractable keyboard Touch Screen Adjusts the brightness of the touch screen Microphone Activa...

Page 351: ...ected continuous wave pencil transducer 2D 2D Mode Displays selections for 2D mode imaging M M Mode Displays selections for M mode C Color Displays selections for Color CDV and Power CDE modes D Doppler Displays selections for Doppler 3D 3D 4D Displays selections to acquire three dimensional images using the 3 Scape real time 3D imaging feature 4D 3D 4D Displays selections to acquire and simultane...

Page 352: ...iority mode Adjusts the overall contrast resolution of an image sweep or spectrum Note For systems without a touch screen this selection is assigned to DYN R DVR Displays a control on the touch screen for recording images during imaging when a digital video recorder is connected and configured for use with the system SieScape SieScape Displays selections to acquire two dimensional ultrasound image...

Page 353: ...o depict a qualitative view of tissue stiffness and provide a quantitative measurement of shear velocity and elasticity Note For systems without a touch screen the selection is assigned to a button eSieScan Protocols Displays a list of the available workflow protocols A protocol is a pre defined checklist that guides you through a clinical workflow When a workflow protocol is selected the image me...

Page 354: ...o 30 views for the active protocol Pause Protocol Resume Pause Protocol Resume Temporarily pauses or resumes the protocol End Protocol End Protocol Saves all data ends the active protocol and displays a message if any protocol views are not complete Add View Add View Inserts a new view immediately before the active view Rename View Rename View Displays a dialog box to enter a new name for the view...

Page 355: ...he syngo Arterial Health Package AHP software program Note For systems without a touch screen the selection is assigned to a button syngo VVI syngo VVI Velocity Vector Imaging Activates the syngo Velocity Vector Imaging syngo VVI software program Note For systems without a touch screen the selection is assigned to a button syngo Auto LHA syngo Auto LHA Activates the syngo Auto Left Heart software ...

Page 356: ...he selection is on the LED panel Tint Changes the color of the image by adding blue red yellow or green to the gray in a gray map Available settings transducer dependent Note For systems without a touch screen the selection is on the LED panel Edge Edge Enhancement Distinguishes the contours of a structure during imaging 0 none 1 to 4 Note For systems without a touch screen the selection is on the...

Page 357: ...le and enhance tissue differentiation in 2D mode images Available settings Transducer dependent Note If you activate color when Advanced SieClear is enabled the system changes the compounding level to 3 if the current setting is higher than 3 Note For systems without a touch screen the selection is on the LED panel DTCE Dynamic Tissue Contrast Enhancement Reduces speckle from the image The selecte...

Page 358: ...ted Contrast Detail Penetration Soft General LVO Fetal Echo 1st Trimester User Defined user defined image presets Note The User Defined setting is available only when a user defined exam is selected Use this setting to save a customized image optimization preset Note For systems without a touch screen the selection is on the LED panel Timer Start Timer Stop Timer Activates or deactivates the on sc...

Page 359: ...p by adding blue red yellow or green to the gray in a gray map Available settings transducer dependent THI Tissue Harmonic Imaging Enables or disables the Tissue Harmonic Imaging feature used to enhance contrast resolution Full Screen Trace Full Screen Trace Activates a full screen format for the M mode sweep Note For systems without a touch screen the selection is assigned to a button Split Scree...

Page 360: ...le filter settings and lower PRFs You may experience increased flash motion artifacts General Gen Produces an optimal balance between flash suppression and maximum sensitivity by using an adaptive wall filter High Optimizes the system for the high arterial flow common to pulsatile vessels and stenotic conditions Fetal Echo Optimizes the system for viewing the blood flow in a fetal heart Note For s...

Page 361: ...n calculating the power amplitude display 0 to 4 Note For systems without a touch screen the selection is on the LED panel Smooth Spatial Averaging Smoothing Adjusts the level of spatial both axial and lateral averaging used to smooth the flow pattern display 0 to 3 Note For systems without a touch screen the selection is on the LED panel Maps When CDV is activated selects a processing curve that ...

Page 362: ...e sample area DTE Presents the Doppler signal energies returning from the tissue DTA Presents the rate of change of velocities acceleration in the sample area Note For systems without a touch screen this selection is assigned to IMAGE Invert Affects only the active priority mode Vertically flips the Doppler spectrum on the baseline negative values display above the baseline and inverts the Doppler...

Page 363: ...peed Sweep Speed Adjusts the horizontal speed of the Doppler spectrum NTSC 1 2 4 6 8 PAL 1 2 5 7 8 Note For systems without a touch screen the selection is on the LED panel Steer Reverse Available only for pulsed wave Doppler Available only for linear array transducers Steer Reverse Reverses the Doppler angle gate axis and Doppler spectrum Note For systems without a touch screen the selection is a...

Page 364: ... Lv 2D Lv D Frz D Lv 2D Frz D Lv 2D Lv D Lv 2D EOS end of sweep D Lv 2D 2s every two seconds D Lv 2D 4s every four seconds D Lv 2D 8s every eight seconds Note The selections available depend on the active image Auto Stats Auto Statistics Enables or disables the display of Doppler statistics On Off Auto Stats On Available only for pulsed wave Doppler Selects the trace settings to use data above the...

Page 365: ...ing affects only the active priority mode Vertically flips the Doppler spectrum on the baseline negative values display above the baseline and inverts the Doppler audio Vertically flips the colors depicting forward and reverse flow in the color ROI and in the color bar Steering Angle Available only for pulsed wave Doppler Available only for linear transducers Change the steering angle within the t...

Page 366: ...o change the default clip capture for an exam type System Config Basic System 2 Default Protocol Settings Selection Description Stress Echo Launch Stress Echo Activates the Stress Echo exam current setting Change Capture Definition Specifies the clip length The settings are available based on the protocol selected in system presets Time 3 sec 2 sec 5 sec 10 sec R wave 3 beats 1 beat 2 beats 4 beat...

Page 367: ...cates the end of the CINE data Annotation Selections Selection Description Keyboard Shows or hides the touch screen keyboard Text Tab Selects application specific text annotations for an image Body Marker Tab Displays a body marker on the screen and activates body marker selection Arrow Tab Displays an arrow on the screen and activates arrow selection Set Home Changes the default position of the a...

Page 368: ...t Available only on systems without a touch screen Adds the selected annotation term to the screen A Available only on systems without a touch screen Add Text A text Displays the first annotation term in the A list then cycles through the selections in the list B Available only on systems without a touch screen Add Text B text Displays the first annotation term in the B list then cycles through th...

Page 369: ... marker for the currently displayed body marker Note For systems without a touch screen the selection is assigned to a button Move Set Repositions and anchors the body marker Available only on systems without a touch screen Add Arrow Changes the text cursor into an arrow for placement of an arrow on the image screen Delete Arrow Delete last Arrow Deletes the current arrow Length Changes the length...

Page 370: ...en the selection is assigned to a soft key 2D Measurement Tools Selection Description Distance Depth Distance Calculates the length of a straight line Ellipse Ellipse Determines area diameter and circumference 2D Trace Trace Calculates the circumference of an irregular shape inside a manual trace Open Trace Open Trace Calculates the diameter of an irregular shape inside open manual trace eSieCalcs...

Page 371: ...Performs a manual waveform trace RI S D Resistive Index Systolic Diastolic Calculates the RI and SD ratios on a frozen Doppler spectrum Acceleration Slope Measures acceleration or deceleration of speed over time Time Time Measures time between two delimiters Heart Cycle Heart Cycle Measures the velocities means maximums and ratios for one heart cycle Velocity Ratio Velocity Ratio Calculates the ra...

Page 372: ...nt Tools Selection Description Distance Distance Calculates the length of a vertical line Heart Rate Heart Rate Defines the number of heart cycles between two delimiters Acceleration Slope Measures the change in distance over time Time Time Measures time on an M mode sweep ...

Page 373: ...current exam and displays the patient registration form Edit Report Available only for the cardiac exam Displays a version of the cardiac report that you can edit End Exam Ends the current exam OB History Displays previous fetal biometry when entered Transfer Report Available for the following exams Breast obstetric cardiac gynecology and vascular Sends the patient report to the network path speci...

Page 374: ...ce Trace Trace Calculates the circumference of an irregular shape Vol MOD Vol MOD Determines the circumference area long axis length and volume of a structure Doppler Time Time Measures the change in time between two points Velocity Velocity Determines velocity V and pressure gradient PG HR HR Heart Rate Measures the heart rate using one heart cycle Acceleration Accel Acceleration Measures the cha...

Page 375: ...nce between four points on a line to determine IVS LVID and LVPW HR HR Heart Rate Determines heart rate using one heart cycle Cardiac Report Controls Selection Description Edit Report Opens a version of the report that you can edit Page Displays the page number and total number of pages Prev Displays the previous page of the selected group of measurements Next Displays the next page of the selecte...

Page 376: ...maining on media Displays the estimated time in hours and minutes remaining for recording before media space is filled current space used on media Displays the percentage of space used on the media View Disk Displays the viewer screen for playback Finalize Prepares the contents of the media for playback on other devices Eject Ejects the media from the recording device Recording Icons The ultrasoun...

Page 377: ... the syngo Auto Left Heart software program Note For systems without a touch screen the selection is assigned to a button Contrast Dyn Contrast Dynamics TM software Activates the syngo Contrast Dynamics software program Note For systems without a touch screen the selection is assigned to a button Page of Selects a page of images Note For systems without a touch screen use the scroll wheel or the L...

Page 378: ...iews Use the system configuration menu to specify the sequence that views are displayed in the thumbnail panel System Config eSieScan Workflow Protocols Compare Compare Mode Displays only the selected images static images clips or volumes in the sequence the images were selected of Displays the number of images selected for comparison and the total number of images in the study Remove image s Remo...

Page 379: ...ction of clip playback Jump to First Frame Jump to First Frame Displays the first frame of the displayed clips Note For systems without a touch screen the selection is assigned to a button Step Backward Step Backward Displays the previous frame of the displayed clips Note For systems without a touch screen the selection is assigned to a button Play Play Pause Replay Begins playback of the displaye...

Page 380: ...a touch screen the selection is assigned to a button Single Select Single Select Selects an image and cancels selection of any previously selected image Note For systems without a touch screen the selection is assigned to a button Multiple Select Multiple Select Selects an image and retains the selection of any previously selected image Note For systems without a touch screen the selection is assi...

Page 381: ...on is assigned to a soft key Selected Indicates the number of currently selected images Copy to Film Indicates the number of images copied to the filming screen Deleted Indicates the number of images that are tagged for deletion Flagged Indicates the number of images that are marked with a flag Total Indicates the total number of images and clips displayed on the review screen all pages Images Ind...

Page 382: ... bar 1 Beginning of the clip 2 Location of the currently displayed frame 3 End of the clip 4 Playback speed 5 Current frame number Example of the expanded clip bar 1 Frame number of the starting margin of the clip 2 Frame number of the current frame 3 Frame number of the ending margin of the clip ...

Page 383: ...ng from the filming screen when automatic printing is disabled Selection Description Page corner icon Displays the next or previous page of images Copies Sets the number of copies to print for the selected film job Selection Description Film Task Status Displays film job information Delete Deletes the selected image s or the selected film job from the filming screen Expose Film Task Immediately se...

Page 384: ...ext Displays image text for the selected image s Customized Text Displays customized image text for the selected image s No Text Hides image text for the selected image s Show Graphics Displays graphics for the selected image s Hide Graphics Hides graphics for the selected image s Fit to Segment Displays the selected image s as large as possible without clipping given the size of their segment s O...

Page 385: ...rom a connected HIS RIS server CD DVD storage location Displays patient data stored on the inserted disk Patient Folder Local Database or CD DVD Displays study folders within the patient folder This icon is displayed in tree view only for patient data in the local database or on an inserted disk Study Folder Displays series objects within the study folder This icon is displayed in tree view only f...

Page 386: ...e study to the Siemens FTP site Show MPPS Available only for patient data stored on the local database Show MPPS Displays the Modality Performed Procedure Step dialog box which lists MPPS data for the selected study Note When you select a patient folder the system automatically selects the most recent study folder when you select Local Database the system automatically selects the first patient fo...

Page 387: ...ve device This menu selection indicates the currently configured default archive device Archive to Displays the Archive To dialog box which lists destinations archive devices for archival of the selected patient data When the archival is complete the system updates the work status of the patient data to Archived This selection is available only for patient data on the local database Send to __ Sen...

Page 388: ...e system imports the selected patient data files to the local database Note You can also enter a location and press Enter on the keyboard to display the contents of the entered location Export to Off line Displays the Export to Off line dialog box which lists locations on the system s hard disk or supported external media and export options for the selected patient data The system exports the sele...

Page 389: ...nd restores the data to the previously saved state Clear Scheduler Removes all pre registered patients and scheduled patients Empty Recycle Bin Permanently removes deleted items from the recycle bin Find Locates data on the system based on specified parameters Mark Assigns mark bookmark work status to the selected patient data Marked items of patient data can be filtered for display Unmark Removes...

Page 390: ...ked displays patient data according to the pre selected format options for tree view layout When not checked displays patient data according to the pre selected format options for single view layout Note Use the Browser Configuration dialog box to configure the format options for tree view or single view layout Image Stamps When checked displays miniature representations of the images within the s...

Page 391: ...for viewing of patient data stored on the local database 3 CD DVD When checked displays the icon for viewing of patient data stored on an inserted disk Filter Menu Selections Menu Selection Description Button Off Disables any activated filter and displays all patient data Not Archived Displays only patient data without an archived work status Not Printed Displays only patient data without a printe...

Page 392: ...ed work status Not available for the Scheduler 3 Sent Sent work status Not available for the Scheduler Reverse Order Reverse order in the selected sorting option Sort Selections for Patient Folders Selection Sorts Study Folders by Study Description Study description Study Date and Time Study date and time Work Status 1 Printed Printed work status 2 Archived Archived work status 3 Sent Sent work st...

Page 393: ...rk status Multiple Displays the Image Display Order dialog box which lists multiple sorting options Reverse Order Reverse order in the selected sorting option above Options Menu Selections Selection Description Configure Browser Displays the Browser Configuration dialog box which contains options for customizing the display of the patient browser Filter Settings Displays the Filter Specification d...

Page 394: ...Appendix D On screen Controls D 50 Instructions for Use ...

Page 395: ...d fourSight Editing Controls 13 SieScape Controls 14 Speed Indicator 16 Contrast Agent Imaging Selections 16 Multi Modality Review On screen Controls 18 Reference Images Screen 21 Physiologic Function Controls 21 Selections Used in the Stress Echo Feature 22 Select Protocol Dialog Box 22 Acquisition Selections 22 Stress Echo Screen 23 Toolbar Buttons 23 Select Mode Selections 25 Review Mode Select...

Page 396: ...Measurement Window 40 3D Window and Magnification Window 40 Global Measurements Window 41 M mode R waves Crop Window 41 Dyssynchrony Analysis Window 42 Contrast Dynamics Software Controls 44 Contrast Dynamics Context Menus 46 Select Destination and File Format Dialog Box 46 Select Destination Dialog Box 46 syngo Arterial Health Package AHP Controls 47 AHP Screen Navigation Panel 47 Image Quality P...

Page 397: ...ouch technology Use the trackball and SELECT controls on the control panel to interact with the on screen controls To view additional controls on the touch screen you can rotate the Page control select More or select Next Page or Previous Page depending on the currently active function For systems without a touch screen the system displays the controls on the on screen menu except as noted in this...

Page 398: ...ll wheel and the LED panel controls to adjust the settings EI Color Activates or deactivates the color map Off deactivates the color map 1 applies a range of color to depict tissue stiffness from soft to hard 2 applies blue to depict harder tissue and red to depict softer tissue Note For systems without a touch screen the selection is on the LED panel Split Available only for systems with a touch ...

Page 399: ...gth Scan Length Selects the scan length for volume acquisition Available settings transducer dependent Angle Scan Angle Selects the scan angle for volume acquisition Available settings transducer dependent Speed Scan Speed Selects the scan speed for volume acquisition Fast Medium Slow Scan Time Scan Time Selects the time of acquisition in seconds for Spatial Temporal Image Correlation STIC 7 to 18...

Page 400: ... selected image optimization settings for 3D or 4D images Amnioscopic Fetal Brain Fetal Heart Spine 1st Trimester 2nd 3rd Trimester Endometrium Uterus Adnexa Note For systems without a touch screen this selection is assigned to IMAGE Quadrant Selects the required slice or volume Note For systems without a touch screen this selection is assigned to the scroll wheel Slice Changes the view from plane...

Page 401: ...th perception Amnioscopic Simulates scattering of directed light within an object producing translucency and shadowing effects Surf Shading Heightens contrast creating a textured appearance for highlighting internal features Uses the selected shading opacity percentage and thresholds Note Surf Shading is available only when CDE is activated Note Only Opacity Gradient Light and Amnioscopic renderin...

Page 402: ...f 5 Note For systems without a touch screen the selection is on the LED panel Shading Adjusts the shading effects used in surface shading rendering 0 to 100 in increments of 5 Note For systems without a touch screen the selection is on the LED panel Priority Tissue Reject Priority Adjusts the threshold for displaying 2D versus color or power data in any pixel For example increasing the color prior...

Page 403: ...rants Sync Aligns the MPR and volume orientation When the selected quadrant is an MPR the system aligns the orientation of the volume to that of the MPR Note If the VOI is displayed when you select an MPR quadrant and then click Sync the system redefines the render direction to match the selected MPR Center On each slice repositions the focal point to the center of the quadrant Flip Reverses the r...

Page 404: ...een the selection is assigned to a button Thick Slice Imaging Thick Slice Imaging Displays tools to adjust the thickness of an individual slice to improve contrast resolution Note For systems without a touch screen the selection is assigned to a button Curved MPR Curved MPR Displays tools for drawing a curved MPR multiplanar rendering to straighten curved anatomy Note For systems without a touch s...

Page 405: ... C or C affects only the volume rendering 2D 2D C C Available only when VOI is disabled Wireframe Enables or disables the display of the wireframe in the volume quadrant Automatic Rotation Automatically rotates the volume according to the selected range speed and axis Note The system dithers the editing selections while the volume is automatically rotating Rotation Range Rotation Range Selects rot...

Page 406: ...Available only when a volume of interest VOI is activated Render Direction Select the orientation of the volume of interest Skeletal Rendering Skeletal Rendering Activates or deactivates optimization of the fetal spine Bone Enhance Available only when fetal skeletal rendering is activated Bone Enhancement Adjusts the percentage of contrast in a skeletal rendering 0 to 100 ...

Page 407: ...all the voxels outside the selected plane Note This selection is not available when VOI is enabled Niche Removes all the voxels from the nearest corner of the volume to a selected depth inside the volume Note This selection is not available when VOI is enabled Large Eraser Displays the large eraser cursor for editing Small Eraser Displays the small eraser cursor for editing Undo Last Edit Undo Las...

Page 408: ...tion is assigned to a button Redisplay Displays the full screen SieScape image or CINE Note For systems without a touch screen the selection is assigned to a soft key Restore Scales the SieScape image to the original display of the frozen image Note For systems without a touch screen the selection is assigned to a soft key Resize Adjusts the size of the image Full full acquisition size Fit fits th...

Page 409: ...ays in the SieScape image Note For systems without a touch screen the selection is assigned to a soft key Col Cap Color Capture Enables continuous capture of power data without transducer movement Note For systems without a touch screen the selection is assigned to a soft key Flow Activates or deactivates power data without stopping image acquisition Note For systems without a touch screen the sel...

Page 410: ...tarted When the image is frozen the system also displays the time when freeze occurred Off On Note For systems without a touch screen the selection is assigned to a soft key Reset Timer Reset Timer Sets the timer to zero and automatically starts the timer 00 00 00 FR Control Not available during Doppler or M mode Frame rate control Limits the frame rate to the selected maximum value Available Sett...

Page 411: ... without a touch screen the selection is on the LED panel See also Transmit Power Control Safety and Care Chapter 2 Instructions for Use Protocol Selects the clip capture duration in seconds sec 30 45 60 90 user defined ADI Enables the Agent Detection Imaging ADI technique during contrast agent imaging On Off CPS CHI Available only when ADI is disabled Enables the contrast pulse sequence CPS or co...

Page 412: ...ulti Modality Review in wide screen format 1 Reference data 2 Ultrasound image 3 Multi Modality Review thumbnail panel Note For systems without a touch screen the controls for multi modality review are located on the image menu on the left side of the screen and soft key selections are located at the bottom of the screen ...

Page 413: ...vious reference image in the thumbnail panel Note For systems without a touch screen the selection is assigned to a button Zoom Zoom Increases or decreases the magnification of the reference image 10 15 25 35 50 75 100 125 150 200 Note For systems without a touch screen the selection is assigned to a button Pan Repositions the reference image and displays a box indicating the visible part of the r...

Page 414: ...election is assigned to the trackball Apply To All Apply to All Applies the current window contrast and level brightness settings to all static gray scale reference images Note For systems without a touch screen the selection is assigned to a button Restore Image Restore Image Cancels the most recent changes to the window and level settings for the displayed reference image Note For systems withou...

Page 415: ...s in the selected study Select All Selects all of the displayed thumbnails Select None Clears the selection of all thumbnails OK Closes the Reference Images screen and displays the first selected thumbnail in a side by side format with the ultrasound image during an active exam In review displays the selected images in the MMR thumbnail panel Cancel Closes the Reference Images screen without loadi...

Page 416: ...to list its constituent views all other phases are contracted The system expands the next phase in the sequence once images have been acquired for each view in the current phase Selection Description Start Acquisition Starts stress echo acquisition for non continuous stages End Acquisition Stops stress echo acquisition when the last stage is completed Pause Temporarily stops continuous acquisition...

Page 417: ...ta with loops selected as preferred only one representative loop for each view Report Preview Displays the report for the current mode when available Reports are available for Wall Motion Scoring Mode and LV Mode Print Prints the report for the current mode when available Reports are available for Wall Motion Scoring Mode and LV Mode Record Pause Records Stress Echo data to external media Maintena...

Page 418: ...loop segment for display Drop down list Available settings Systole Displays the systole segment only all loops User defined Allows manual repositioning of review markers on the loop bar to exclude frames from review selected loop only Fixed range Displays the and buttons for repositioning of review markers on the loop bar to exclude frames from review all loops Decrement left marker position Displ...

Page 419: ...he preferred loop for the view If no loop is designated as preferred for the selected view then these buttons have no effect Button Description Scroll Up Displays loops in the previous view Scroll Down Displays loops in the next view Home Selects the first loop in the currently displayed view To Left Selects the previous loop in the currently displayed view To Right Selects the next loop in the cu...

Page 420: ...ther stage Display Selected Loops Displays the selected phases side by side for each selected view This button is available only when the Shuffle Mode button is disabled Accept When automatic review is enabled saves the loop for the current stage and activates acquisition for the next view in the stage Sets the second to last loop as the preffered loop and saves all loops for reference Reject When...

Page 421: ...ection the system displays the views and WMS graphics in their original sizes and locations Enter WMS Comment Displays the WMS Comment dialog box and then saves the entered text to the WMS Report WMS Comment Dialog Box Stress Echo Selection Description text box Text box for entry of comments Insert text Displays the Select text to insert dialog box for selection of predefined terms OK Saves change...

Page 422: ...ges and closes the dialog box Select Text to Insert Dialog Box Selection Description list of predefined terms Factory default terms and user defined terms Edit Displays the Edit text dialog box for revising the selected term New Displays the Create new text dialog box for entering a new term Delete Removes the selected term from the list Defaults Restores the factory default list of terms Insert t...

Page 423: ...label on the loop in the Stress Echo screen Heartrate Displays the heart rate at which the loop was acquired on the loop in the Stress Echo screen Time stamp acquisition Displays the time of acquisition on the loop in the Stress Echo screen Timespan since start of level Displays the time elapsed from the beginning of the phase to this loop s acquisition on the loop in the Stress Echo screen This v...

Page 424: ...c ASE 16 5 Scores or ASE 17 5 Scores Configures the system to display the indicated type of WMS graphics 16 segment or 17 segment and the following wall motion scores for assignment X Cannot evaluate 1 Normal 2 Hypokinetic 3 Akinetic 4 Dyskinetic 5 Aneurysmal ASE 16 7 Scores or ASE 17 7 Scores Configures the system to display the indicated type of WMS graphics 16 segment or 17 segment and the foll...

Page 425: ...lues to the QT Time Table Syst Duration Allows you to enter a systolic duration When a heart rate and systolic duration are both entered you can add this pair of values to the QT Time Table Reset table Restores the default values in the QT Time Table Update Adds the entered heart rate and systolic duration to the QT Time Table Delete Removes the selected heart rate and systolic duration pair from ...

Page 426: ...s the stage as Retrospective Prospective or Continuous Loops When a phase is selected in the Stage list allows you to select the number of loops to be acquired for each view in the selected phase Note This selection is not available for continuous stages View First Specifies the first view to acquire when the selected stage is activated If no views are selected the first view acquired is the view ...

Page 427: ...the systolic portion of the heart cycle R R Full captures the full heart cycle systolic and diastolic portions Note The captured heart cycle segments portions can be edited You can select loop segments for display or you can reposition the review markers WMS model Lists the WMS models available for selection to be used by default in the protocol New Clears the Protocol Name selection and allows yo...

Page 428: ...n you activate syngo Auto Left Heart The view selection screen prompts you to select a chamber and image view 1 A4C and A2C view selections 2 Anterior or inferior left ventricular or left atrial wall indicator for A2C view only 3 LV and LA chamber selections 4 Clip Transfer progress indicator 5 Image from a clip Note The contrast view buttons do not display when LA is selected ...

Page 429: ...ram displays the syngo Auto Left Heart screen when you select the image view 1 Image display area 2 Volume graphs 3 Location of buttons 4 Heart Cycle indicator 5 Calculation data 6 Frame corner indicating the active image 7 Long axis 8 Outline of the structure 9 Current view and image orientation 10 Frame number ...

Page 430: ...the active chamber LA Selects the left atrium as the active chamber A4C Selects the apical four chamber image view non contrast for the displayed clip A2C Selects the apical two chamber image view non contrast for the displayed clip A4C Contrast Selects the contrast apical four chamber image view for the displayed clip A2C Contrast Selects the contrast apical two chamber image view for the display...

Page 431: ...Heart algorithm to all frames in the clip SET ED Selects the currently displayed frame as the representative frame for the End Diastole image SET ES Selects the currently displayed frame as the representative frame for the End Systole image Backup Erases the most recent segment or marker of a user created outline Available during tracing of a new outline and before the outline is complete Mark Act...

Page 432: ...Short Axis Selects the Short Axis algorithm for processing the trace Generic Curve Selects the Generic Curve algorithm for processing the trace Average Heart Cycle When selected enabled calculates and displays the motion parameters for the average heart cycle by averaging the values from the multiple R R intervals Note This selection is available for multiple cycle clips after processing only Endo...

Page 433: ...Displays all curves on the curve plot Toggle Original Border Points to Equispaced Points x4 Toggles display of the user defined trace points with display of the program generated trace points M mode R waves Crop Displays the M mode R Waves Crop window where you can View clip in M mode Add move or delete R wave indicators Crop long clips Toggle Filtered Unfiltered Plots Adjusts the smoothing in cur...

Page 434: ... plot for magnification 3D Displays the 3D window including the 3D rendering of information in the related parametric M mode graph Toggle Filtered Unfiltered Plots Adjusts the smoothing in curves on all curve plots all windows Export Saves an image or clip to a storage device network destination or to the computer s hard disk Close Exits the displayed window and redisplays the VVI window 3D Window...

Page 435: ...LAX Calc Area Displays only if Long Axis is select on the VVI window When selected enabled calculates the area enclosed by the trace Close Exits the displayed window and redisplays the VVI window M mode R waves Crop Window Control Description Gamma Adjusts the gamma image setting changes both brightness and contrast Restores the original gamma image setting Reset Removes the currently displayed fr...

Page 436: ...rcumferential Reverse Peak For all parameters except strain longitudinal strain circumferential strain rate longitudinal and strain rate circumferential identifies the lowest point the point that is 75 of the lowest point or the point that is 50 of the lowest point as determined by the Time To selection For parameters strain longitudinal strain circumferential strain rate longitudinal and strain r...

Page 437: ... When selected enabled displays all curves When cleared disabled displays selected curves only Note Data on the window includes values for the displayed curves only Toggle Filtered Unfiltered Plots Adjusts the smoothing in curves on all curve plots all windows Zoom Magnifies the graph Click Close to return to the Dyssynchrony Analysis window Export Exports an image or clip to a storage device netw...

Page 438: ...3 Intensity Curve quadrant 4 Time Window quadrant Example of Contrast Dynamics screen Control Description Gamma Adjusts the brightness of the image Activates the selected drawing tool Rectangle Ellipse Trace Motion Compensation Compensates for patient movement to stabilize the image in the region of interest On Off Process Activates parametric analysis ...

Page 439: ...C Area under curve MTT Mean transit time Exponential Peak Beta Slope Capture Enables capture and integration of contrast agent data over time to improve vascular detail On Off Note If the contour region is not defined the program captures the entire clip image If the contour region is defined the program captures only the defined region of interest Play Stop Starts or ends playback of the clip Nex...

Page 440: ...ys the ROI previously copied to memory on the parametric image Delete ROI Deletes the selected region of interest Set Bounds Displays a dialog box to select the range of values for each parameter displayed by the color map A color scale displays below the parametric image with the selected range Toggle Real Calculated Curves Displays real curves unsmoothed data calculated curves smoothed data or b...

Page 441: ...ts Displays the CIMT report and report selections Setup Displays the AHP Setup screen Exit Exits the AHP program Image Quality Panel The image quality panel displays on the right of the screen Icon Description Prior Displays the previous frame of the clip Run Starts playback of the displayed clip Stop Stops playback of the displayed clip Next Displays the next frame of the clip Zoom Magnifies the ...

Page 442: ...tivates the edit function for the far media adventitia boundary Manual trace lumen intima Activates the manual trace function for the far lumen intima boundary Manual trace media adventitia Activates the manual trace function for the far media adventitia boundary Trace Editing Tools Button Description Clear borders Deletes the current border and the CIMT ROI region of interest Toggle exclude frame...

Page 443: ...tic Output Reference Display Accuracy and Measurement Uncertainty 3 Default Displayed MI and TI Values by Transducer 4 Track 3 FDA 510 k and IEC 60601 2 37 Acoustic Output Reporting 6 Summary Table for Acoustic Output 6 Definitions 8 Legend 9 ...

Page 444: ...Appendix F Acoustic Output Reference F 2 Instructions for Use ...

Page 445: ...y The MI and TI display values should be interpreted as relative information and only used to assist the operators to implement the ALARA As Low As Reasonably Achievable principle for patient examinations the acoustic output should be the lowest level required to satisfactorily perform the examination Measurement uncertainty for acoustic pressure acoustic intensity power and center frequency is wi...

Page 446: ...B2 0 9 1 9 S1 12L4 0 8 0 8 1 3 0 6 B2 0 6 S1 0 8 0 6 B2 0 6 S1 14L5 1 0 0 9 1 1 1 8 B2 0 9 1 2 S1 14L5 SP 0 8 0 9 0 6 1 0 B2 1 3 0 8 S1 18L6 HD 1 0 0 7 1 0 1 2 B2 1 0 0 6 S1 4P1 1 2 1 0 S1 1 4 1 9 B2 1 0 3 8 B2 1 2 1 2 S1 4V1 0 8 0 4 S1 1 1 1 4 B2 0 9 4 3 B2 0 8 0 8 S1 4V1c 1 4 0 9 S1 1 4 1 4 B2 1 0 3 7 B2 1 4 1 1 S1 8V3 0 6 0 5 S1 1 2 0 4 B2 1 4 2 5 B2 0 7 0 9 S1 10V4 0 8 1 0 S1 1 5 0 4 B2 0 6 1 ...

Page 447: ... B2 0 1 3 4 B2 1 1 1 4 S1 4V1 0 8 0 4 S1 1 1 1 4 B2 0 9 4 3 B2 0 8 0 8 S1 4V1c 1 1 1 1 S1 1 4 1 3 B2 0 7 3 6 B2 0 1 3 5 B2 1 3 1 1 S1 8V3 1 0 0 9 S1 1 2 0 7 2 4 B2 0 1 2 0 B2 1 1 0 9 S1 10V4 0 5 1 0 S1 0 7 0 3 2 1 B2 0 1 2 2 B2 0 7 1 2 S1 V5Ms 0 3 0 7 0 2 0 7 B2 0 1 1 3 B2 0 5 V7M 0 3 0 5 0 3 0 9 B2 0 6 B2 0 6 EV 8C4 0 9 0 5 S1 1 3 0 7 B2 1 2 2 0 B2 1 0 0 6 S1 EC9 4 0 4 0 4 0 6 1 0 B2 0 8 0 4 S1 7...

Page 448: ...er than 1 0 for each transducer mode A Track 3 and IEC 60601 2 37 format acoustic output table is supplied for each transducer mode combination marked with an X Operating Mode Transducer Model B mode 2D 2D mode THI M mode Pulsed Doppler Color Flow or Power SCW Doppler CW Doppler Available on the ACUSON S1000 system ACUSON S2000 system and the ACUSON S3000 system 4C1 X X X X X 6C2 X X X X X 9L4 X X...

Page 449: ...anned is reported if it is larger than 1 0 Color Flow or Power May include simultaneous color flow M mode B mode and Doppler In combined modes the largest displayed TIS scanned or non scanned is reported if it is larger than 1 0 Combined modes The output is reported as a separate mode if the largest formulation of TIS TIB or TIC if an intended use is greater than the corresponding value reported f...

Page 450: ...um i e zsp zB 3 Depth for TIB cm z PII 3max z at max Ipi α The axial distance corresponding to the maximum of the derated spatial peak pulse intensity integral megapascals Depth at the point where the free field attenuated pulse intensity integral is a maximum cm deq z deq z Equivalent beam diameter as a function of axial distance z and is equal to 0 5 TA o z I W 4 π where ITA z is the temporal av...

Page 451: ...ace n a units n a Maximum Value n a Other Information n a Operator Control n a TX Level transmit level n a Focal length n a Focus n a Gate Size n a Sample Rate n a Res Speed n a Ensemble Size n a Frequency n a PRF Pulsed Repetition Frequency n a a This Index is not relevant to this operating mode n a b This transducer is not intended for transcranial or neonatal cephalic uses n a c This formulatio...

Page 452: ... in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4C1 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 32 0 39 1 54 As...

Page 453: ...ion condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4C1 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 31 1 42 3 56 3 25 Associated Acoustic Parameters FDA IEC Unit...

Page 454: ... for TIS is less than that for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 6C1 HD Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan No...

Page 455: ...de No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 6C1 HD Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 40 1 30 4 13 Associated...

Page 456: ...ulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 6C1 HD Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 40 0 73 1 ...

Page 457: ... in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 6C2 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 50 2 04 2 05 As...

Page 458: ...ion condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 6C2 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 27 1 00 3 69 4 01 Associated Acoustic Parameters FDA IEC Unit...

Page 459: ...tion for TIS is less than that for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 8C3 HD Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non sca...

Page 460: ... mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 8C3 HD Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 41 0 82 1 23 Associa...

Page 461: ...n in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 8C3 HD Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 0 92 0 20 0 39 0 3...

Page 462: ...in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 9L4 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 36 1 31 1 55 Ass...

Page 463: ...or this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 9L4 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 20 2 19 2 19 2 80 Associated Acoustic Parameter...

Page 464: ...TIS is less than that for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 12L4 Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan ...

Page 465: ... mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 12L4 Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 21 1 01 1 45 Associate...

Page 466: ...mulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 12L4 Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 38 0 29 0 4...

Page 467: ...n this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 14L5 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 35 0 98 1 11 Ass...

Page 468: ...r this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 14L5 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 22 2 91 2 91 2 22 Associated Acoustic Parameter...

Page 469: ...less than that for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 14L5 SP Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aapr...

Page 470: ... mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 14L5 SP Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 45 1 15 1 51 Associ...

Page 471: ...rmulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 14L5 SP Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 31 0 41...

Page 472: ...n in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 18L6 HD Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 28 0 17 0 ...

Page 473: ...r this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 18L6 HD Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 50 1 92 1 92 1 40 Associated Acoustic Parame...

Page 474: ... fawf MHz 6 97 6 48 6 78 6 48 Dim of Aaprt X cm 1 38 1 08 1 38 Y cm 0 40 0 40 0 40 Other Information PD td µsec 0 27 PRF prr Hz 600 00 Pr PIImax Pr max Ipi MPa 4 78 deq PIImax deq max Ipi cm 3 70 Focal Length FLx cm 3 00 3 00 FLy cm 1 80 1 80 Ipa 3 MImax Ipa α max MI W cm 2 603 46 Operator Control Frequency MHz 8 00 8 00 8 00 8 00 Focus cm 1 50 3 00 2 00 3 00 Gate Size cm 1 00 1 00 1 00 1 00 Sampl...

Page 475: ...on in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4P1 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 38 0 96 3 14 ...

Page 476: ...tion condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4P1 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 34 1 12 2 77 2 15 Associated Acoustic Parameters FDA IEC Uni...

Page 477: ...t for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4P1 Operating mode SCW Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 M...

Page 478: ... in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4V1 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 50 1 11 2 86 As...

Page 479: ...on condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4V1 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 29 1 44 3 76 3 65 Associated Acoustic Parameters FDA IEC Units...

Page 480: ...ation for TIS is less than that for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4V1c Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan...

Page 481: ...mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4V1c Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 36 0 93 2 61 Associated...

Page 482: ...ormulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 4V1c Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 0 80 0 41 1...

Page 483: ...hat for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 8V3 Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Max...

Page 484: ...mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 8V3 Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 49 1 15 2 36 Associated ...

Page 485: ...e formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 8V3 Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 56 0 40...

Page 486: ...for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 10V4 Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximu...

Page 487: ...s mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 10V4 Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 48 1 29 1 74 Associat...

Page 488: ...nate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 10V4 Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 50 ...

Page 489: ... for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model V5Ms Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maxim...

Page 490: ...peration condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model V5Ms Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 12 0 55 0 88 0 73 Associated Acoustic Parameters FDA IE...

Page 491: ...r an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model V5Ms Operating mode SCW Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maxi...

Page 492: ...ode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model V7M Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 06 0 35 0 53 Associated A...

Page 493: ...ulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model V7M Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 16 0 34 0 72 ...

Page 494: ... for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model EV 8C4 Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Max...

Page 495: ... mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model EV 8C4 Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 48 0 96 1 32 Associa...

Page 496: ...lation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model EV 8C4 Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 89 0 23 0 3...

Page 497: ... in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model EC9 4 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 31 0 26 0 71 ...

Page 498: ...eration condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model EC9 4 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 0 98 1 14 1 20 1 25 Associated Acoustic Parameters FDA IE...

Page 499: ...or TIS is less than that for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model MC9 4 Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non s...

Page 500: ...mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model MC9 4 Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 30 0 99 1 34 Associate...

Page 501: ...nate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model MC9 4 Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 4 ...

Page 502: ...n in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 7CF1 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 36 0 7 1 04 A...

Page 503: ...ration condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 7CF1 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 37 1 2 2 3 2 18 Associated Acoustic Parameters FDA IEC Un...

Page 504: ... for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 7CF2 Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maxim...

Page 505: ...ode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 7CF2 Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 23 0 81 1 62 Associated ...

Page 506: ...rmulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 7CF2 Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 34 0 55 0 ...

Page 507: ...on in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 9EVF4 Operating mode 2D Mode THI MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 28 0 33 0 4...

Page 508: ...s operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model 9EVF4 Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 34 0 85 1 01 0 91 Associated Acoustic Parameters FD...

Page 509: ... for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model CW2 Operating mode CW Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Max...

Page 510: ...ernate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model AcuNav 8F Operating mode 2D Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Val...

Page 511: ...peration condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model AcuNav 8F Operating mode Pulsed Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 55 0 97 2 79 2 71 Associated Acoustic Parameters F...

Page 512: ...for an alternate formulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model AcuNav 8F Operating mode SCW Doppler MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt...

Page 513: ...de No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model AcuNav 10F Operating mode Color Power MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 53 1 26 3 04 Associ...

Page 514: ...rmulation in this mode No data is provided for this operation condition since the maximum index value is not reported for the reason listed Acoustic Output Reporting Table Track 3 FDA 510 k and IEC 60601 2 37 Per transducer mode that exceeds MI or TI value of 1 0 Transducer model AcuNav 10F Operating mode M Mode MI TIS TIB TIC Index Label Scan Non scan Non scan Aaprt 1 Aaprt 1 Maximum Value 1 50 0...

Page 515: ...0 40 deq zsp deq zb cm 0 10 fc fawf MHz 4 00 4 00 4 00 4 00 Dim of Aaprt X cm 0 15 0 15 0 15 Y cm 0 25 0 25 0 25 Other Information PD td µsec PRF prr Hz Pr PIImax Pr max Ipi MPa 0 11 deq PIImax deq max Ipi cm 0 10 Focal Length FLx cm 2 01 2 01 FLy cm 1 30 1 30 Ipa 3 MImax Ipa 3 MI max W cm 2 0 28 Operator Control Frequency MHz 4 00 4 00 4 00 4 00 Focus cm 2 01 2 01 2 01 2 01 Gate Size cm Sample Ra...

Page 516: ...Appendix F Acoustic Output Reference F 74 Instructions for Use ...

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