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Zimmer Sonido Smart Instructions For Use Manual Download Page 3

 
 

 

CE mark 

 

 

 

 

 

This product conforms to the essential requirements of the Medical Devices 

Directive 93/42/EEC. Accessories without the CE mark are not guaranteed 

to meet the essential requirements of the Medical Devices Directive. 

 

 

These instructions for use refer to the device SonidoSmart ab SN 1701001. Please verify that you are 

using the most up-to-date version of this document. If you need the latest edition, please contact your 

distributor. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NOTE:

 

Important: 

1.

 

No part of this manual may be abridged, altered, copied or reprinted, in whole or in part, without the 

prior written permission of Zimmer MedizinSysteme GmbH. 

2.

 

The contents of this manual are subject to change without prior notice and without legal obligation. 

3.

 

Before using the system, please read this manual carefully and completely. The instructions for use 

constitute an integral part of the appliance. Please keep the instructions for use in an easily accessi-

ble place after reading. If you have any questions or doubts, please contact ZIMMER MEDIZINSYS-

TEME or your authorised service technician. 

Summary of Contents for Sonido Smart

Page 1: ...Instructions for Use SonidoSmart EN ...

Page 2: ...Ultrasound diagnostic system Model SonidoSmart Dec 2017 Instructions for use For SonidoSmart from SN 1701001 Ident no EN 10102699TM 1217 ...

Page 3: ... distributor NOTE Important 1 No part of this manual may be abridged altered copied or reprinted in whole or in part without the prior written permission of Zimmer MedizinSysteme GmbH 2 The contents of this manual are subject to change without prior notice and without legal obligation 3 Before using the system please read this manual carefully and completely The instructions for use constitute an ...

Page 4: ...contact your ZIMMER MEDIZINSYSTEME authorised service technician immediately Please describe the situation clearly in order to resolve the problem in good time Please do not operate the system until the problem has been resolved 6 This system must not be used by persons other than fully trained medical personnel 7 It is strictly prohibited to use the device for determining the sex of a fetus excep...

Page 5: ...nts such as paint thinners benzene or alcohol or abrasive cleansers for cleaning the system including the monitor and probes etc These can cor rode the system and probes 16 When the system or probe has exceeded its operational lifespan please refer to the operat ing manual section 9 4 17 Important data must be saved to external storage media ZIMMER MEDIZINSYSTEME shall not be liable for loss of da...

Page 6: ... the patient environment 7 2 5 Biological safety 9 2 6 Scanning patients and training 10 2 6 1 Guidelines for safe scanning 10 2 6 2 Understanding the MI TI display 11 2 6 3 Instructions for handling the battery 16 Chapter 3 System introduction 17 3 1 Console overview 17 3 2 Dimensions 17 3 3 View 17 3 4 Introduction to functions 19 3 4 1 Image modes 19 3 4 2 Accessories 20 3 4 3 System configurat...

Page 7: ...n keys knobs 27 4 2 1 SWITCH 27 4 2 2 PATIENT 27 4 2 3 PROBE 27 4 2 4 SETUP 28 4 2 5 END 28 4 2 6 Body marker 28 4 2 7 COMMENTS 28 4 2 8 ARROWS 28 4 2 9 DEL 29 4 2 10 Pressure 29 4 2 11 Archive 29 4 2 12 Report 29 4 2 13 Parameter control button 29 4 3 Central control unit 30 4 3 1 ENTER 30 4 3 2 UPDATE 30 4 3 3 EXIT 30 4 3 4 Cursor 30 4 3 5 CHANGE 30 4 3 6 Distance measurement DIST 31 4 3 7 Curve...

Page 8: ... 7 STC 33 4 5 8 GAIN 33 4 5 9 ANGLE ZOOM knob 33 4 5 10 DEPTH FOCUS knob 33 4 5 11 Info display with indication of the device status 33 4 5 12 CONTROL LIGHT 34 Chapter 5 Operating and examination mode 35 5 1 Preparing the system for use 35 5 1 1 Device inspection 35 5 1 2 Turning on 35 5 2 Selecting the examination mode 35 5 2 1 Probe detection 35 5 2 2 Mode selection 35 5 3 Inputting patient info...

Page 9: ...namics 39 5 6 3 i image 39 5 6 4 Connection 39 5 6 5 PW 40 5 6 6 M speed adjustment 40 5 6 7 GAIN 40 5 6 8 STC 40 5 6 9 Depth 40 5 6 10 Focus 40 5 6 11 Angle 40 5 6 12 ANGLE ZOOM 40 5 6 13 INVERT 40 5 6 14 THI 41 5 6 15 AIO 41 5 7 B image menu adjustment 41 5 7 1 Scan width 41 5 7 2 Focus point 41 5 7 3 Persistence 41 5 7 4 Line density 41 5 7 5 Smoothing 42 5 7 6 Edge enhancement 42 ...

Page 10: ... 44 5 8 8 Colour map 45 5 8 9 Audio 45 5 8 10 Acoustic power 45 5 8 11 Invert 45 5 8 12 Wall filter 45 5 8 13 Velocity 45 5 8 14 PRF 45 5 8 15 Baseline 45 5 9 Full screen display this feature must be activated in setup 46 5 10 Edit comments 46 5 10 1 Overview 46 5 10 2 Inputting characters 46 5 10 3 Inputting comments from the character library 47 5 10 4 Editing quick comments 47 5 10 5 Inputting ...

Page 11: ...matic loop 54 5 13 4 Saving and recalling images 54 5 13 5 Saving and retrieving cines 54 5 13 6 Deleting images 54 5 13 7 Sending images 54 5 14 Browsing an image 54 5 15 Archive management 56 5 16 Report 57 5 17 DICOM 58 5 17 1 DICOM Worklist 58 5 17 2 DICOM storage 58 5 17 3 DICOM printing 59 Chapter 6 Measurements and calculations 60 6 1 Keyboard for measurement 60 6 1 1 Trackball 60 6 1 2 ENT...

Page 12: ...h curves 70 6 7 Paediatric measurement 71 6 7 1 HIP angle 71 6 8 GYN measurement and calculation 71 6 9 Small parts measurement and calculation 74 6 10 B mode vessel measurement and calculation 75 6 11 Urology measurement and calculation 75 6 12 Cardiac measurement and calculation 76 6 13 Normal measurement and calculation in M B M mode 77 6 13 1 meas 77 6 13 2 Time 77 6 13 3 Heart rate 77 6 13 4 ...

Page 13: ...t 83 6 25 PW abdomen measurement 84 6 26 PW OB measurement 84 6 27 PW GYN measurement 84 6 28 PW cardiology measurement 85 6 29 PW vascular measurement 88 6 30 PW urology measurement 88 6 31 PW small parts measurement 88 6 32 PW paediatrics adjustment 88 Chapter 7 Presets 89 7 1 General setup 89 7 2 Measurement 91 7 2 1 General measurement setup 91 7 2 2 Measurement formula setup 92 7 3 Annotation...

Page 14: ... 106 7 7 Network 106 7 8 System 106 7 8 1 System information 106 7 8 2 Upgrading 107 7 8 3 Function setup 107 7 8 4 Installation setup 107 7 8 5 Video VGA 107 7 8 6 Image function 107 7 8 7 System maintenance 107 7 8 8 USB video printer option 107 Chapter 8 System maintenance 108 8 1 Cleaning the machine 108 8 2 Probe maintenance 108 8 3 Safety check 110 8 4 Checking for malfunctions 111 8 5 Funct...

Page 15: ... disinfecting TV and TR probes 122 9 3 4 Thermal and probe tip angle monitoring 123 9 4 Service responsibility 124 Appendix A Acoustic output report table 126 Appendix B EMC guidelines and manufacturer s declaration 151 Appendix C Summary of measurement results 155 Appendix D Display accuracy and acoustic measurement uncertainties 156 Appendix E Maximum surface temperature for the transducer 157 ...

Page 16: ...s small parts breast testes thyroid examinations for cardiac examinations paediatrics peripheral vessels musculoskeletal conventional superficial and transvaginal exam inations 1 1 2 Contraindications The system is NOT intended for ophthalmic use or any examinations that cause the acoustic beam to pass through the eye 1 1 3 Contact information For additional information or assistance please contac...

Page 17: ... standard Check the leakage current and other safety parameters of the entire system to avoid possible damage and risks caused by leak age currents and their overburdening The system does not have any special protective measures for the event that it is combined with high frequency devices The operator should use extreme caution with these types of devices as a matter of principle The system may o...

Page 18: ...tric shock in particular with regard to the permitted leakage current BF Insulation against earth max patient leakage current under normal conditions 100 μA in the event of the first failure 500 μA Degree of protection against harmful ingress of water The parts of the probe that are likely to come in contact with the user or the patient meet the requirements for protection against dripping water I...

Page 19: ...g stations cannot be predicted theoretically with any accuracy In order to assess the elec tromagnetic environment with regard to the fixed transmitters an investigation into the electromagnetic radiation on site should be considered If the measured field strength at the location where the ultrasound system is used exceeds the permitted EMC level the ultrasound system must be monitored to see if i...

Page 20: ...n of the product includes changes to Cables length material wiring etc System configuration components User modifications can lead to deterioration of the EMC properties Modification of the product includes changes to Cables length material wiring etc System installation layout System configuration components Attachment of the device components open close lid screwing on the cover ...

Page 21: ...electrical voltage Unplug the mains plug before opening the system Do not use the following devices in the vicinity of the sys tem mobile phone radio receiver mobile radio transmit ter remote control toy etc Using these devices near the system may cause the device to deviate from the given specifications Keep these devices switched off when you are near the system Please note the dangers of electr...

Page 22: ...ts 1 footswitch port 1 mains port Rear side 2 probe ports 1 USB port 1 BNC port 1 video output Battery holder Probe holder Approved devices The devices listed above have been classified as suitable for operation in the PATIENT ENVIRONMENT CAUTION DO NOT connect any probes or accessories that have not been approved by ZIMMER MEDIZINSYSTEME for use within the PATIENT ENVIRONMENT Do not touch the pat...

Page 23: ...tion data installation and interconnection with the system conform to the requirements of EN60601 1 An adapter is considered part of the medical electrical device Connecting equipment other than that specified in the operating manual may result in a risk of electric shock Re placement or alternative devices and connections need to be checked for compatibility and compliance with stand ard EN 60601...

Page 24: ...the following guidelines Clinical safety by AIUM Released on 26 March 1997 Diagnostic ultrasound has been in use since the late 1950s Given its known benefits and recognised efficacy for medical diagnosis including use during human pregnancy the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use There are no confirmed biological effects on patients or dev...

Page 25: ...d by trained medical personnel Diagnostic ultrasound procedures should be performed only by personnel who are fully familiar with and trained in the use of the equipment who can safely interpret the results and images and are sure in the use of ultrasound including training on potential hazards Operators must be aware of the possible influences of device operation and the operating mode e g B mode...

Page 26: ...far more dan gerous than any effect that might result from the ultrasound exposure The diagnostic ultrasound system should there fore only be operated by those with sufficient training and experience 2 6 2 Understanding the MI TI display Track 3 follows the output display standard for systems that include fetal Doppler applications The acoustic output is not evaluated in an application specific wa...

Page 27: ...red concurrently Therefore the acoustic power measurement is normally performed in the water tank and when the soft tissue replaces water along the ultrasound path a decrease in intensity is expected The fractional reduction in intensity caused by attenuation is denoted by the derating factor RF RF 10 0 1 a f z Where a is the attenuation coefficient in dB cm 1 MHz 1 f is the transducer centre freq...

Page 28: ...r 5 TIB Soft tissue and bone Unscanned Bone in focus Fetus head PW 6 TIC Soft tissue and bone Un scanned scanned Bone at the surface Transcranial Soft tissue Describes low fat content tissue that does not contain calcifications or large gas filled spaces Scanned auto scan Refers to the steering of successive bursts through the field of view e g in B and colour mode Unscanned The emission of ultras...

Page 29: ...he TIS and TIB are both greater than 1 0 the scanners need not be capable of displaying both indices simultaneously If the index falls below 0 4 no display is re quired The display increments are no greater than 0 2 for index values less than one and no greater than one for index values greater than one e g 0 4 0 6 0 8 1 2 3 Display and report Located in the upper middle section of the system disp...

Page 30: ...GC WARNING Be sure to read the descriptions of the individual controls for each operating mode you use and make sure that you have understood them before attempting to adjust the acoustic output power or other con trols that affect the acoustic output power Use the minimum necessary acoustic output power for achieving the best diagnostic photogrammetry during an examination Begin the exam with the...

Page 31: ...o any physical shock Never perform direct soldering of the battery ends Do not attempt to disassemble or modify the battery in any way Do not put the battery in a microwave oven or pressurised container Do not use the battery in combination with primary batteries such as dry cell batteries or batteries of any other capac ity type or brand Do not use the battery if it exudes odour generates heat di...

Page 32: ...17 Chapter 3 System introduction 3 1 Console overview Console overview 3 2 Dimensions 335 mm length 155 mm width 350 mm height 3 3 View System front view ...

Page 33: ...m side view 1 Ethernet 2 VGA 3 USB 4 Footswitch 5 Power supply connection Console overview 1 Probe holder 2 Probe 3 Operator keyboard System rear view 1 Probe 2 USB 3 BNC 4 Video 5 Battery holder 6 Probe holder ...

Page 34: ... M mode GYN measurement software package small parts measurement software package ventricular function measurement software package and user defined formula 7 Has a case number display with an arrow for the body marker a real time information display on the image and user defined annotation 8 Has a multi lingual user interface options for modifying the user interface a shear plate printing DICOM3 ...

Page 35: ...ae diatric examinations small parts breast testes thyroid gland peripheral vessels musculoskeletal Peripheral devices VGA output for external monitor VIDEO output for B W video printers LAN port LAN for DICOM and image viewing station USB 2 0 for flash drive Footswitch 3 4 3 System configuration Configuration SONIDOSMART Colour Black white Probe connectors 2 Max memory 8 GB Built in battery Defaul...

Page 36: ...ic gel May be optional depending on the device variant Subject to change and addition 3 4 6 Probes Various probes are optionally offered for the SonidoSmart system described in the instructions for use Item number Description 8181 Linear probe L7S A 30mm 8182 Linear probe L7M A 45mm 8183 Convex probe C3 A Subject to change and addition 3 4 7 Licences Licences are optional and can be ordered in add...

Page 37: ...tors High humidity Note This equipment generates uses and can radiate radio frequencies The equipment may cause radio frequency interfer ence with other medical and non medical equipment and radio communications To provide proper protection against such interference this product adheres to the emission limits for Group 1 Class A of the Directive for Medical Devices as defined in EN 60601 1 2 Howev...

Page 38: ...d or appears abnormal in any way during use recharging or storage immediately remove it and stop using it If you still have questions about the battery and short term storage of the battery pack less than a month Store the battery in the temperature range between 0 C 32 F and 50 C 122 F Long term storage of the battery pack 3 months or more Store the battery in the temperature range between 20ºC 4...

Page 39: ... on the cart to move it NOTE Walk slowly and carefully when moving the system Do not let the system strike walls or door frames Transporting the system Take extra care when transporting the system in a vehicle After preparing the system as described above please take the following additional safety precautions Only use suitable vehicles to transport the system Before transporting place the system ...

Page 40: ... shut down CAUTION If the system is connected using the wrong power supply unit the incorrect power supply may cause dam age to the system and injuries to users 3 5 3 Probe installation Caution Please only use the probes provided by the manufacturer for this model other types of probes are not permit ted for use with this system Otherwise this can lead to damage to the system and probe CAUTION Bef...

Page 41: ...e rear side of the printer and connect the other side to the print control port on the rear of the unit 4 Connect the video printer s power cable to the power supply system 5 Adjust the preset printer parameters according to the type of printing paper Caution Do not use any other power cable as a replacement for the 3 wire cable provided by the manufacturer otherwise there is a risk of electric sh...

Page 42: ...meric keyboard Alphanumeric keyboard for entering patient number name characters etc 4 2 Function keys knobs 4 2 1 SWITCH Turn the device on or off 4 2 2 PATIENT Input patient data 4 2 3 PROBE Press this button to select the connected probes ...

Page 43: ... complete an examination 4 2 6 Body marker Press this key to enter the body markers menu select body markers and confirm the scan position on the screen On ly available in Freeze mode 4 2 7 COMMENTS Press this button to enter text input 4 2 8 ARROWS Use the Arrow key to add arrow keys to the image ...

Page 44: ...port via the connected video printer 4 2 11Archive This key takes you to archive management where patient information can be viewed and edited 4 2 12 Report Use this button to create save and retrieve examination reports 4 2 13 Parameter control button Use these keys to increase or decrease the corresponding parameters on the screen or to open or close the functions ...

Page 45: ...n input 4 3 2 UPDATE This multifunction button works in conjunction with the trackball and depending on the device status certain functions can be executed Example Retrieve an annotation and return to the measurement 4 3 3 EXIT By pressing this key you can exit a measurement dialogue or menu 4 3 4 Cursor Press this key to show or hide the cursor 4 3 5 CHANGE Press this key to change the menu 9 ENT...

Page 46: ... a second time to select a menu item and change the parameters Press the MENU knob a third time to exit the current menu item By turning the MENU knob you can toggle between the individual menu items or change them accordingly 4 3 10 Trackball The trackball is the main operation tool on the screen The function of the trackball differs depending on the individual operation statuses 4 4 Image mode k...

Page 47: ...ress this key to open or close the THI function 4 5 2 AIO Press this key for automatic image optimisation 4 5 3 CINE Press this key to save the current cine loop 4 5 4 SAVE Press this key to save the current image 4 5 5 Reverse left right Press this key to invert the image from left to right ...

Page 48: ...ion between angle and zoom 4 5 10 DEPTH FOCUS knob Press the knob to adjust the depth and operating position or to switch the function between depth and focus position 4 5 11 Info display with indication of the device status From left to right in the top line Hard disk cable network USB disk icon Click this icon to display the capacity of the disk or CD required to store the data in the current sy...

Page 49: ... display Displays the connection situation of the battery simply press this icon to display the present battery sta tus the charging and discharging status the remaining electrical voltage and the remaining time available 4 5 12 CONTROL LIGHT From left to right Power adapter indicator charge status indicator standby indicator Power adapter indicator When the unit is connected to the power source v...

Page 50: ...wait until the system appears on the user interface and activate the probe slot in B mode 5 2 Selecting the examination mode 5 2 1 Probe detection By default the system automatically detects the current probe type When the probe is being inserted press to change the probe CAUTION Only connect or disconnect the probe when the system is stationary in order to ensure stability and extend the operatio...

Page 51: ... Procedure 1 Move the trackball to the position of the input area and click ENTER then enter the patient information using the character keyboard 2 Use the trackball and the ENTER key to select from the various input options ID patient name doctor s name birthday can be automatically calculated by entering the age age can be automatically calculated by entering the birthday gender 3 If necessary c...

Page 52: ... can be scrolled through using the mode key 5 5 1 B mode If you press the B mode key the single B mode image is displayed B mode is the basic mode for two dimensional scanning and diagnosis 5 5 2 B B mode Press 2B to display double B mode images side by side One image is in real time the other is a freeze frame The real time image has a start scan mark and a ruler mark Press the 2B button in B B m...

Page 53: ...olume gate can be moved anywhere within the B mode image PW mode examination procedure Obtain a good B mode image Press the PW button to display the sample volume cursor and gate Position the sample volume cursor by rotating the trackball left and right Position or size the sample volume gate by moving the trackball up and down then press the ENTER button Press the UPDATE button to display the PW ...

Page 54: ...nd ENTER Move the sample volume on the B mode Doppler cursor The gate is positioned above a certain position within the ves sel To move the position of the Doppler cursor turn the trackball left or right until it reaches the position above the vessel To move the position of the sample volume gate move the trackball up or down until it is inside the vessel To adjust the sample volume gate size pres...

Page 55: ...to change the depth of the image 5 6 10 Focus Press the FOCUS selection knob until the FOCUS indicator lights up Then turn the knob to change the focus position 5 6 11 Angle Change the sampling line angle of the sampling gate in PW mode Press ANGLE ZOOM and confirm that the light for ANGLE is lit the sampling line rotates with the direction 5 6 12 ANGLE ZOOM Press the ANGLE ZOOM knob until the ANG...

Page 56: ...MENU button again 5 7 1 Scan width Select Scan width and adjust the scan width to the appropriate size 5 7 2 Focus point In B mode up to two focus points can be selected simultaneously and the number can be controlled by the depth SRA and compound Move the cursor to the Focus num selection to adjust within the range of 1 2 5 7 3 Persistence In real time status adjust the contrast and resolution To...

Page 57: ...ION DOES NOT MAKE SENSE IS NOT LISTED IN THE WINDOW 5 7 9 Utility software This function includes post processing slide show and other items Press the MENU button then select the utility soft ware the utility software options are displayed there Chroma Adjust the type of colour display Activate Chroma and turn the MENU button to select the colour display type within the range of 0 31 Map Select th...

Page 58: ...ng MB the image quality is improved Update MB and turn the MENU control to adjust within the range of 0 3 Trapezoidal mode Press MENU to turn the trapezoidal function on or off Biopsy Show or hide the biopsy Press MENU to show or hide the biopsy line Centre line Show or hide the centre line Press MENU to show or hide the centre line ...

Page 59: ...D 2D map Adjusts the D 2D map Activate the D 2D map and turn MENU the usual adjustment range is 1 4 5 8 4 Enhance Adjusts the enhancement Activate Enhance and turn MENU to adjust the enhancement the adjustment range is 0 3 5 8 5 D gamma Adjusts the D gamma Activate D gamma and turn MENU to adjust the D gamma the adjustment range is 0 8 5 8 6 Dynamics Adjusts the dynamics Activate Dynamic and turn ...

Page 60: ... 8 11 Invert Press the parameter control button then press invert or press the button to invert the spectrum 5 8 12 Wall filter Press the parameter control button and then Wall filter to adjust the wall filter the adjustment range is 0 3 5 8 13 Velocity Press the parameter control button and then Speed to adjust the speed the adjustment range is 0 2 5 8 14 PRF Adjusts the PRF Press the parameter c...

Page 61: ... comments are classified according to the examination mode as follows Classification Description of functions Abdomen Abdomen general anatomical term Obstetrics Anatomical term for obstetrics Gynaecology Anatomical term for gynaecology Heart Anatomical term for heart Small parts Anatomical term for small parts Lesion Lesion term Abdomen obstetrics gynaecology heart small parts NOTE If you need cus...

Page 62: ...atus and press the ENTER key to activate it 2 Move the trackball to move the comment to the target area 3 Press ENTER again to confirm the comment 5 10 7 Editing comments 1 Move the trackball in comment status and press the ENTER button to activate it 2 Press BACKSPACE to delete unnecessary characters 3 Press ENTER to confirm 5 10 8 Deleting comments Deleting characters In comment status activate ...

Page 63: ...al description The body marker indicates the patient s examination position and the direction of the probe scan on the image Body markers are divided into obstetrics abdomen gynaecology heart and small parts each of these has a different body marker Each type of body marker automatically corresponds to the current examination mode Icon Abdomen markers Heart markers ...

Page 64: ...49 Obstetrics markers Gynaecology markers Paediatric markers Urology markers ...

Page 65: ...50 Small parts markers Vascular markers ...

Page 66: ...51 Nerve markers Quick markers ...

Page 67: ...want to exit the body marker function press the button again 6 Press EXIT to exit the body status and the body marker is anchored to the screen 7 Press DEL to delete body markers 5 12 Set the direction of the arrow Operation 1 Press to display the arrow 2 Press the CHANGE button to select the cursor type arrow or cross And change the size of the cursor 3 Adjust the position of the probe By rotatin...

Page 68: ...al order maximum frame rates can be set for this The maximum number of frames for the cine storage can be set please refer to the chapter on presets If the cine memory is full the last frame is saved to memory and the previous frame is deleted 120 120 maximum frames the last frame saved to the memory current frame previous frame Cine loop display diagram ...

Page 69: ...or to the required image and confirm using ENTER to retrieve it you can also call up saved patient information in order to call up an image please refer to the chapter Archive for more information 5 13 5 Saving and retrieving cines In freeze frame status press to save a cine this is then displayed in the bottom half of the screen Press EN TER to retrieve the cine again 5 13 6 Deleting images After...

Page 70: ...end image to the USB disk or DICOM memory unit and print Delete pictures Delete the selected image Line Column Select image format Cover page page up Next page Page back New examination Exit the current examination and open a new dialogue box Continue examination Exit the user interface for image browsing and continue the examination of the current patient Archive Open the user interface for archi...

Page 71: ...Backup examination Select examination data to USB hard disk Restore examination Restore examination data from a USB hard disk Send examination Remote transmission of the selected examination to a USB hard disk or DICOM memory print DI COM activation required Delete examination Delete the selected examination data Patient view Change the data display mode Expand all Select patient view display a su...

Page 72: ... title Report options various types of reports can be selected such as normal obstetrics GYN etc Clinic Dis plays the name of the clinic Abdomen report Displays the report type Name of the patient Displays the patient name Age Displays the patient s age Gender Displays the patient s gender Patient ID Displays the patient s ID Diagnosis Entry for the diagnostic instructions Description Entry for th...

Page 73: ... gender Doctor Display of the name of the treating physician Account no Display of the patient number Search Press this button to start a search operation Apply Select the searched patient and press this button inputs all patient information into the new patient interface Delete Delete the entire content of the search 5 17 2 DICOM storage Check save and send in the settings when saving cines and i...

Page 74: ...rt button to store to DICOM Enter the DICOM task sequence and view edit the DICOM procedure 5 17 3 DICOM printing The DICOM printing procedure is the same as that for DICOM storage 5 15 4 DICOM SR Press the Send DICOM SR button on the report interface and that task is added to the DICOM task sequence ...

Page 75: ...ions are as follows 1 Before starting a measurement use the trackball to select the menu options 2 After starting a measurement move the trackball to move the cursor during the measurement the cursor should not be moved outside the image area 3 During ellipse method measurement use the trackball to change the length of the short axis 4 Update the movement of the measurement result move the trackba...

Page 76: ...int and to adjust another point of the line 4 Move the cursor to the end point and press ENTER again to complete the measurement 5 After the measurement the result is displayed in the measurement results area 6 Repeat steps 1 to 4 to start the next distance measurement Press the DEL key to delete all measurements NOTE Each measurement group has a limited number of measurements if the measurement r...

Page 77: ...ents if the measurement results exceed this a new measurement group is added automatically 6 2 4 Histogram Histogram is used to calculate the greyscale distribution of the ultrasound echo signals within a specified area Use the rectangle ellipse or trace method to draw along the desired measurement area The result is displayed in the form of a histogram The histogram can only be measured on the fr...

Page 78: ...uick measurement Press the DIST button to enter quick measurement in B mode Press the corresponding parameter control button to change the quick measurement point Measurement menu Submenu Unit Measurement method Measurement formula Comments Distance Distance cm See distance meas urement Ratio distance See distance meas urement Formula R D1 D2 D1 First distance D2 Second distance Angle deg See dist...

Page 79: ...istance Distance Area circle Area cm2 Circle cm See ellipse and trace meas Ellipse and trace Press UPDATE to change Volume 1 straight line ml See distance meas Formula V π 6 D3 D denotes Depth Volume 1 ellipse ml See ellipse meas Formula V π 6 A B2 A Long axis B Short axis Volume 2 straight line ml See distance meas Formula V π 6 D1xD22 D1 The longer distance D2 The shorter distance Volume 3 strai...

Page 80: ...mula R D1 D2 D1 First distance D2 Second distance Ratio Area See ellipse Distance Formula R A1 A2 A1 First area A2 Second area Angle Degrees See distance Distance Angle range 0 180 histogram See histogram Cross sectional di See Cross sectional ...

Page 81: ...t cm See distance Distance Width cm See distance Distance StD See distance meas Formula D1 D2 D1 100 D1 Length of normal D2 Length of stenosis StA See ellipse meas Formula A1 A2 A1 100 A1 Area of normal A2 Area of stenosis Vessel area cm2 See ellipse and trace meas Ellipse and trace Press UPDATE to change Vessel dis cm See distance Distance Mid aorta The same as above The same as above The same as...

Page 82: ...gth Height Width cm See distance meas Pelvis Rt Lt Height cm See distance Distance Width cm See distance Distance StD See distance meas Formula D1 D2 D1 100 D1 Length of normal D2 Length of stenosis StA See ellipse meas Formula A1 A2 A1 100 A1 Area of normal A2 Area of stenosis Vessel area cm2 See ellipse and trace meas Ellipse and trace Press UPDATE to change Vessel dis cm See distance Distance 6...

Page 83: ...k Hansmann Johnsen Korean Merz APPD cm See distance Distance Formula Bessis TAD cm See distance Distance Formula CFEF AC cm See ellipse and trace meas Formulae for selection CFEF Campbell Hadlock Hansmann Korean Merz Shinozuka TRICHLO ROACETIC ACID cm See distance Distance Formula Osaka FL cm See distance meas Formulae for selection Bes sis CFEF Campbell Chitty Doubilet Hadlock Hans mann Hohler Je...

Page 84: ...a Chitty Hill for selection Posterior cistern cm See meas on distance NF cm See meas on distance NB cm See meas on distance OOD cm See meas on distance Formula OOD IOD cm See meas on distance NB cm See meas on distance Paracele cm See meas on distance Formula Tokyo HC Width cm See meas on distance Obstetrics oth er LtRenal cm See meas on distance RtRenal cm See meas on distance LtRenalAP cm See me...

Page 85: ...erature 4 Update the ovulation date in the input box and enter the basal bodily temperature date on the new page for the pa tient s obstetrics 5 The procedure is the same as that used with the LMP method 6 6 2 Growth curves Function Comparison of growth curves is used to compare the measured data of the fetus with the normal growth curve in order to judge whether the fetus is growing normally Meas...

Page 86: ...NGLE will be displayed in the measurement results area CAUTION D 3 shows the baseline between the protruding joint and the hipbone D 2 shows the direct line between the ilium and acetabular bone D 1 shows the baseline between the joint socket joint cul de sac periosteum cartilage and ilium is the angle between D1 and D 2 acute angle is the angle between D 1 and D 3 acute angle HIP angle 6 8 GYN me...

Page 87: ...it Distance method Comments Distance UT_H cm See Dis on meas UT_V ml See meas V meas π 6 L UT_L H UT_H W UT_W UT_D cm See dis tance meas Formula UT_D LxWxH L UT_L H UT_H W UT_W Cervix vol ml See meas V meas π 6 L Cervix _L H Cervix _H W Cervix _W ENDO cm See Distance meas OVVol L R ml See meas V meas π 6 L OV _L H OV _H W OV _W FOL R FO_L cm See Distance meas FO_B cm See Dis on meas ...

Page 88: ...V meas 6 L UT_L H UT_H W UT_W UT_D cm See distance meas Formula UT_D LxWxH L UT_L H UT_H W UT_W Cervix vol ml See m eas V meas 6 L Cervix _L H Cervix _H W Cervix _W ENDO cm See Distance meas OVVol L R ml See m eas V meas 6 L OV _L H OV _H W OV _W FOL R FO_L cm See Distance meas FO_B cm See Dis on meas ...

Page 89: ... mula V 6 L H W L Thyroid_L H Thyroid_H W Thy roid_W Angle Degrees See Distance meas Angle range 180 Ratio See Distance meas For mula R D1 D2 D1 First distance D2 Second distance 6 9 Small parts measurement and calculation Freeze the required image in the small parts examination then click on Calc to enter the small parts measurement sta tus ...

Page 90: ...state _L H Prostate _H W Prostate _W PPSA ng ml Formula PPSA 0 12 V PSAD ng ml Formula PSAD SPSA V SPSA Entry for SPSA when a new patient is created RVU Volume ml See distance meas Formula V π 6 L H W L RVU _L H RVU _H W RVU _W 6 10 B mode vessel measurement and calculation The same as normal measurement in B mode 6 11 Urology measurement and calculation Normally urology measurements are performed...

Page 91: ...SD Left ventricular parameter at the systole end Distance menu Submenu Unit Distance method Distance formula Comments LV long axis DL LV short axis DD Bi plane ml See distance meas and ellipse meas Formula V 8 3 Ai x Am D D LV short axis Am LV area on mitral valve plane image Ai LV area on the apex plane image Sphere vol ume ml See distance meas and ellipse meas Formula V 5 6 Am L Am LV area on mi...

Page 92: ... measurement result is displayed in the results area 6 13 2 Time Measurement steps Select the time for the menu item to enter the measurement Click on the M image area and two blue dotted lines are displayed within it The blue dotted line with one yellow short line on it represents active status The distance between the two straight lines represents the time that you want to measure You can drag t...

Page 93: ...aximum number of measurement results in the image area is one The second measurement result will cover over the first All the measurement values are listed in the measurement results area 6 14 General measurement in M mode In real time status click on the B M key twice to enter M mode and click on Calc to enter the M mode cardiology measurement status Distance menu Submenu Unit Distance method Dis...

Page 94: ... distance 6 15 M abdomen measurement The same as for general measurement in M mode 6 16 Obstetrics measurements in M mode The same as for general measurement in M mode 6 17 GYN measurement in M mode The same as for general measurement in M mode 6 18 Cardiac measurement in M mode Urology measurements are normally performed in M and B M mode Freeze the desired urology examination image then click on...

Page 95: ...lar volume of the last diastole ESV ml ESV 7 0 2 4 LVIDs LVIDs3 Left ventricular volume at the last systole SV ml SV EDV ESV Stroke volume SI SI SV BSA Stroke volume BSA The body surface area is calculated by in putting the body height and weight EF EF SV EDV 100 Ejection fraction SF SF LVIDd LVIDs LVIDd 100 Shortening fraction CO L min COSV HR 1000 Cardiac output CI CICO BSA ECG index BSA The bod...

Page 96: ...ce flow AVSV MAVO1 MAVO2 LVET 50 AA MAVO1 Aortic opening distance at the beginning MAVO2 Aortic opening distance at the end AA Aortic area Wall motion 6 19 Urology M measurement The same as general measurement in M mode 6 20 Small parts M measurement The same as general measurement in M mode 6 21 Paediatrics M measurement The same as general measurement in M mode 6 22 PW mode measurement methods P...

Page 97: ...he ENTER button to complete the process 3 The measurement results are displayed on the monitor and other parameter values are also calculated 6 23 PW quick measurement Press the Dist button to enter PW quick measurement in PW mode Press the corresponding parameter control button to change the quick measurement point Measurement menu Submenu Unit Measurement method Measurement formula Comments Peak...

Page 98: ...d RI Formula SD Vs Vd Vs Time s See M time measurement Auto trace Manual trace Vs cm s See M speed measurement Pressure mmHg Formula Pressure 4 Vs Vs 10000 Vd cm s See M speed measurement Under pressure mmHg Formula Pressure 4 Vd Vd 10000 VMid cm s See M speed measurement Pressure VMid mmHg Formula Pressure 4 VMid x VMid 10000 TVI cm SD Formula SD Vs Vd RI Formula SD Vs Vd Vs PI Formula SD Vs Vd V...

Page 99: ... s See M speed measurement Pressure mmHg Formula Pressure 4 Vs Vs 10000 Vd cm s See M speed measurement Under pressure mmHg Formula Pressure 4 Vd Vd 10000 VMid cm s See M speed measurement Pressure VMid mmHg Formula Pressure 4 VMid x VMid 10000 TVI cm SD Formula SD Vs Vd RI Formula SD Vs Vd Vs PI Formula SD Vs Vd VMid HR Single wave bpm 6 27 PW GYN measurement Press Calc to enter PW measurement in...

Page 100: ... mmHg Formula MPG 4 VMid x VMid 10000 TVI cm Time s See M time measurement HR Single wave bpm SV ml Formula 0 785 diam di am TVI CO l min Formula SV HR Single wave 1000 AV Diameter cm See B distance measurement Area cm2 See B distance measurement ACC cm s2 See M speed measurement AV curve Vs cm s See M speed measurement AV curve PPG mmHg Formula PPG 4 Vs Vs 10000 AV curve VMid cm s See M speed mea...

Page 101: ...V PHT area cm2 Formula 220 MV PHT E Dur s See M time measurement A Dur s See M time measurement IRT s See M time measurement MV diam cm See B distance measurement MV area cm2 See B distance measurement MV curve Vs cm s See M speed measurement MV curve PPG mmHg Formula PPG 4 Vs Vs 10000 MV curve VMid cm s See M speed measurement MV curve MPG mmHg Formula MPG 4 VMid x VMid 10000 MV curve TVI cm Time...

Page 102: ...ity velocity 10000 PV diam cm See B distance measurement PV trace Vs cm s See M speed measurement PV trace PPG mmHg Formula PPG 4 Vs Vs 10000 PV trace VMid cm s See M speed measurement PV trace MPG mmHg Formula MPG 4 VMid x VMid 10000 PV trace TVI cm Time s PV curve HR bpm Formula 60 Time PV curve SV ml Formula 0 785 diam di am TVI PV trace CO l min Formula SV HR Single wave 1000 RV ET s See M tim...

Page 103: ...lavian A Prox CCA Mid CCA Distal CCA Bulb Prox ICA Mid ICA Distal ICA ECA Vertrebral A General measurement Vs cm s See M speed measurement Pressure s mmHg Formula Pressure 4 Vs Vs 10000 Vd cm s See M speed measurement Pressure d mmHg Formula Pressure 4 Vd Vd 10000 VMid cm s See M speed measurement Pressure VMid mmHg Formula Pressure 4 VMid x VMid 10000 TVI cm SD Formula SD Vs Vd RI Formula SD Vs V...

Page 104: ...as been switched off When the system is switched on it automatically operates in the status requested by the user In the presets user interface all operations rely on moving the trackball to the position for the required function Press the ENTER button to start the operation 7 1 General setup User interface for general settings Press the SETUP key to enter the user interface for system settings Th...

Page 105: ...PG PNG BMP format the size must not exceed 512 384 pixels Language Select language Select the interface language Simplified Chinese English etc Screenshot type Select the required type Set the content that the screen should contain Only image image area and patient information full screen Frame number selection Freely adjustable Set the default frame when saving the cine Options for the image area...

Page 106: ...m2 Volume ml l User interface for general measurement settings Time s ms Velocity cm s mm s Acceleration cm s2 mm s2 Angle degrees rad Weight g kg Measurement result option whether clear results are obtained after freeze frame is cancelled and the automatic still frame image Measurement result The colour of the result font can be altered including yellow white orange green Follicles ways of measur...

Page 107: ...s this button to increase the measurement time Down Press this button to decrease the selected measurement time Add folder Add a measurement item A appears in the left column when the time is a multiple time otherwise there is a Add measurement Add a measurement item for a time period in the right column the selected item and detailed param eters are listed there Add a calculation measurement Add ...

Page 108: ...ivation control Repeat Repeat this item Sequential Measurement by sequence Default item After selecting repeat and sequential choose a measurement or calculation to activate the measurement rule 7 2 2 2 Description of user interface for editing measurements User interface for editing measurement formulae Sheet 3 Measurement editing content description Label Displays the name of the selected term d...

Page 109: ...ement menu otherwise the item will not be displayed Name The measurement operation of the specific measurement display in results Unit Data unit whose measurement procedure produces the following Display report in Whether it is displayed in the report or not Average value method The average data rule Change Press this button to display the user interface for modifying the meas urement O i Remove P...

Page 110: ...ment process for specific measurement and calculation Unit Data unit whose measurement procedure produces the following Display in report Whether it is displayed in the report or not Up Press this button to move the measurement operation up Down Press this button to move the measurement operation down Average value method The average data rule Add Press this button to display the user interface fo...

Page 111: ...it Input via the user interface to edit the formula when selecting the calcu lation I Unit Data unit whose measurement procedure produces the following Display in report Whether it is displayed in the report or not method The average data rule 7 2 2 5 Edit formula normal When creating measurement processes except obstetrics it is necessary to access the following user interface User interface for ...

Page 112: ...interface OK Save edits and close the user interface 7 2 2 6 Edit formula Obstetrics When creating an obstetrics measurement procedure it is necessary to retrieve the built in obstetrics formula sheet the following user interface is required for this function CAUTION The results for gestational age and estimated date of delivery are built in to the unit of this class Measurement points Display of ...

Page 113: ...rent measurement Fetal weight Fetal weight calculation formula EFW equation Fetal weight calculation for the current measurement EFW growth Fetal weight growth curve for the current measurement Info Display of the gestational age and fetal weight for the current measurement Cancel Can cels the formula selection operation Save Save the user s formulae selection ...

Page 114: ... annotation library Operation 1 In annotation status move the cursor to the Edit comment type and then press ENTER the annotation is updat ed and can be edited 2 Input the name of the newly created annotation status box then move the cursor to the Create button and press the ENTER key you then create a new annotation status which then appears in the selected annotation status list 3 Move the curso...

Page 115: ...port all annotations in the source into the status selected by the user and press ENTER on the key to move all annotations in the Comment Selection column into the source annotation 7 3 2 2 Adding an annotation manually Operation 1 Activate the Edit Comment input box using the trackball and ENTER then input the required abbreviation and full name of the annotation 2 Press ENTER on Add and the docu...

Page 116: ...dy marker library Operation 1 Press ENTER on Edit body marker type to display the input box 2 Input the name into the newly created body markers box move the cursor to the Create button and then press ENTER the new body markers are then created and appear in the list of selected body markers 3 Move the cursor onto Delete and press ENTER to delete the current body markers in the selected list 4 Cha...

Page 117: ...atus press ENTER on to move all body markers in the Selection of body markers column into the source 7 4 3 Body marker options Optional Whether a body marker should be removed when freeze frame is cancelled Optional Whether a freeze frame image should be created with a body marker 7 5 Examination mode 7 5 1 Editing the examination mode Press Extras in the submenu of MENU and the following is displ...

Page 118: ...the exam mode bib column into the exam mode selected column delete the selected examination modes from the exam mode selected column delete all examination modes from the exam mode selected column Set as default Set the selected examination modes in the exam mode selection column as default Move up Move se lected examination modes up in the exam mode selection column Move down Move selected examin...

Page 119: ...user Body marker The default body markers required by the user are selected the same way as for comments Meas urement The default measurement menu required by the user is selected the same way as for comments Re name Rename the selected examination mode Delete Delete the selected examination mode Export Export all integrated examination modes to the USB flash disk Import Import all integrated exam...

Page 120: ...on AE title Displays the name of the local DICOM AE title IP displays the IP address of the DICOM server Port Displays the port for the DICOM server Timeout s Displays the delay Available Displays whether DICOM is defined in the default or not Confirm Press the confirm button and display whether the DICOM setup is correct or not Add Add the DICOM function and display the settings dialogue Delete D...

Page 121: ...OM AE server name Server IP address Entry for the DICOM IP ad dress SCP port Entry for the DICOM server SCP port Timeout Set the DICOM delay time Tip The DICOM print type must be selected before the corresponding printer setup is carried out 7 7 Network Set the device s and target device s IP and test the connection 7 8 System 7 8 1 System information Display the software version hardware version ...

Page 122: ...Full screen show see DICOM 7 8 4 Installation setup In order to enter the appropriate key for starting the trial and detailed function please contact ZIMMER MEDIZINSYS TEME 7 8 5 Video VGA Select the video data NTSC or PAL Video opened Select the item to open this function VGA opened Select the item to open this function 7 8 6 Image function Export the device s SN and the device s secret key only ...

Page 123: ...y of the device 8 2 Probe maintenance The probes used by this device can be divided into two series Body surface probes and intra cavity probes For all ultrasound examinations the level of ultrasonic radiation on the human body must be kept as low as possible CAUTION Probes may only be used by persons who have been specially trained to do so Probes may not be sterilised in a pressure steriliser If...

Page 124: ...AUTION Do not place the body surface probe into any liquid beyond the level of the sound outlet lens For the in tra cavity probe the insertion area may not be exceeded The probe connector must not be immersed in liquids Disinfection The probe disinfection procedure is suitable for the intra cavity probe If it is necessary to use this in surgery please follow the instructions for professional probe...

Page 125: ...ix 2 of the MPBetreibV German Medical Products Operator Or dinance In Germany the DGUV Regulation 3 Electrical Systems and Equipment in its current version must also be observed NOTE This note applies to operation of the system in Germany Where applicable comply with any divergent national regula tions in your country To make sure that the device is functioning normally it is recommended to prepar...

Page 126: ... 1 Control power start up gain or STC control 2 Ensure that the connection is correct 3 Exit standby mode 4 Abnormal image 1 Examination mode errors 2 Image processing set tings errors 1 Check whether the examina tion mode is suitable or not 2 Adjusting the image pro cessing Setting as default 5 The probe is not working properly 1 The plug is loose 2 The internal circuit pro tects 1 Pull the probe...

Page 127: ...est 1 Switch the device on 2 Position the selected probe on a suitable body part with ultrasound gel 3 Move the probe while watching the screen to see if the desired body part is displayed with the movement on the screen ...

Page 128: ...e following precautions Do not drop the transducer onto hard surfaces This can damage the transducer elements and compromise the electri cal safety of the transducer Avoid kinking or pinching the transducer cable Use only approved ultrasonic coupling gels Follow the instructions for cleaning and disinfecting that come with each probe 9 2 1 Inspecting the probes Before and after each use carefully ...

Page 129: ...residues of disinfectant Use a soft cloth to clean the cable and the user section of the probe with a liquid cleaning disinfectant Make sure that the surface of the probe and the cable are sufficiently wet with the disinfectant cleaning agent Allow the probe to air dry completely Reconnect the probe to the ultrasound console and place the probe into its holder Immersion levels for the probe CAUTIO...

Page 130: ...e verified that it can be used safely Every time you clean the probe you must perform a more thorough inspection including the cable strain relief and connector Before inserting the connector into the probe port inspect the probe connector pins If a pin is bent DO NOT use the probe until it has been inspected and repaired replaced by a ZIMMER MEDIZINSYSTEME representative The ZIMMER MEDIZINSYSTEME...

Page 131: ...act with the sterilant Only immerse the probe to its specified level Before scanning the patient ensure that no solution has entered the probe s handle If sterilant comes into contact with the patient please refer to the sterilant s instruction manual If the patient is exposed to sterilant e g Cidex via the probe connection ALWAYS avoid contact between the patient and sterilant Only immerse the pr...

Page 132: ...rface Prolonged soaking or scrubbing with a soft bristle brush such as a toothbrush may be necessary if material has dried on the probe surface WARNING To avoid electric shock be sure to turn off the system and disconnect power before cleaning the probe CAUTION Take extra care when handling the lens of the ultrasound transducer The lens face is especially sensi tive and can easily be damaged by ro...

Page 133: ...and equipment damage Do not immerse the probe into any liquid beyond the level specified for that probe Never immerse the transducer connector or probe adapter in any liquid Avoid mechanical shock or impact to the transducer and do not bend or apply excessive force to the cable Contact with inappropriate coupling gels or cleaning agents may result in damage to the transducer Do not soak or saturat...

Page 134: ...smission of infectious diseases even if a disposable barrier covers the instrument during use Medical instruments fall into different categories with respect to their potential for transmitting infections The most criti cal level of instruments are those that are intended to penetrate the skin or mucous membranes These require sterili sation Less critical instruments often called semi critical ins...

Page 135: ...aldehyde Cidex PA hydrogen peroxide peroxyacetic acid 7 5 hydrogen peroxide solution Common household bleach 5 25 sodium hypochlorite diluted to 500 parts per million of chlorine 10 cm in one litre of tap water This agent is effective but generally not recommended by probe manufacturers because it can damage metal and plastic parts Other agents such as quaternary ammonium compounds are not conside...

Page 136: ...ths for transvaginal sonography J Clin Ultrasound 2000 28 295 8 Rooks VJ Yancey MK Elg SA Brueske L Comparison of probe sheaths for endovaginal sonography Obstetrics GynSonidoSmartl 1996 87 27 9 Milki AA Fisch JD Vaginal ultrasound probe cover leakage Implications for patient care Fertil Steril 1998 69 409 11 Hignett M P Claman High rates of perforation were found in endovaginal ultrasound probe c...

Page 137: ...a little ultrasound gel into the condom Take the condom in one hand and put the probe head into the condom Secure the condom on the end of the probe handle Confirm the integrity of the condom and repeat the above steps for the condom if any damage is found on it 9 3 3 Cleaning and disinfecting TV and TR probes We strongly recommend wearing gloves when cleaning and disinfecting endocavitary probes ...

Page 138: ...e probe from the germicidal solution rinse it according to the manufacturer s instructions Rinse all visible germicide residues from the probe and allow it to air dry 9 3 4 Thermal and probe tip angle monitoring The transvaginal and transrectal probes are equipped with a thermal sensor that provides continuous feedback on the temperature of the probe tip The tip temperature is displayed in Celsius...

Page 139: ... card The system is a precise electronic system Defective parts may only be replaced by a ZIMMER MEDIZINSYSTEME authorised service technician Any assembly disassembly handling repair or replacement by any other persons may have an adverse impact on the safety and effectiveness of the systems and probes and thus will reduce the lifespan of the system and probes if such im proper handling occurs as ...

Page 140: ...ed service technician If the head office of the ZIMMER MEDIZINSYSTEME service centre issues the calibration certificate for the system or probe in question the user may continue to use the system or probes in accordance with the calibration certificate However if ZIMMER MEDIZINSYSTEME s headquar ters conclude that the system or probe no longer meets safety and efficacy standards the user should im...

Page 141: ...td μs 0 57 Information prr Hz 2293 6 pr at max lpi MPa 1 23 deq at max lpi cm Ipa αat max MI W cm2 35 21 Operating Mode B B control Focus cm 6 4 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC N...

Page 142: ...on prr Hz 2381 pr at max lpi MPa 2 38 deq at max lpi cm Ipa αat max MI W cm2 35 32 Operating Mode THI B THI B control Focus cm 6 2 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the r...

Page 143: ... 0 59 Information prr Hz 2293 6 pr at max lpi MPa 0 95 deq at max lpi cm 0 8 Ipa αat max MI W cm2 22 8 Operating Mode B M B M B M control Focus cm 5 11 6 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in rela...

Page 144: ... 55 Information prr Hz 2293 6 pr at max lpi MPa 0 87 deq at max lpi cm Ipa αat max MI W cm2 15 02 Operating Mode THI B M THI B M THI B M control Focus cm 5 11 6 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided ...

Page 145: ...in the column relating to MI Acoustic power table System SonidoSmart Transducer model C3 A Operating mode PW Index sign MI TIS TIB TIC Scan No scan No scan Aaprt 1c m2 Aaprt 1c m2 Global maximum index value 0 6 0 4 0 7 Associated pra Mpa 1 acoustic P mW 36 parameters Min of Pα ZsIta α Zs mW 22 03 Zs cm 2 5 Zbp cm 2 61 Zb cm 4 95 Z at maxpi α cm 5 deq Zb cm 0 28 fawf MHz 2 89 3 9 2 89 Attenuation o...

Page 146: ...n prr Hz 3846 2 pr at max lpi MPa 1 63 deq at max lpi cm Ipa αat max MI W cm2 23 46 Operating Mode B B control Focus cm 1 0 5 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the requir...

Page 147: ... prr Hz 4854 pr at max lpi MPa 2 56 deq at max lpi cm Ipa αat max MI W cm2 84 23 Operating Mode THI B THI B control Focus cm 3 5 3 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the r...

Page 148: ...ation prr Hz 3846 2 pr at max lpi MPa 3 73 deq at max lpi cm 0 07 Ipa αat max MI W cm2 154 43 Operating Mode B M B M B M control Focus cm 1 5 0 5 1 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation...

Page 149: ...n prr Hz 3846 2 pr at max lpi MPa 3 73 deq at max lpi cm 0 07 Ipa αat max MI W cm2 154 36 Operating Mode THI B M THI B M THI B M control Focus cm 1 5 0 5 1 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in ...

Page 150: ...rmation prr Hz 3424 7 pr at max lpi MPa 1 84 deq at max lpi cm Ipa αat max MI W cm2 27 45 Operating Mode PW PW PW control Focus cm 1 5 1 5 1 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC...

Page 151: ...ion prr Hz 3846 2 pr at max lpi MPa 1 02 deq at max lpi cm Ipa αat max MI W cm2 32 96 Operating Mode B B control Focus cm 2 6 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the requir...

Page 152: ...on prr Hz 4082 pr at max lpi MPa 2 34 deq at max lpi cm Ipa αat max MI W cm2 105 36 Operating Mode THI B THI B control Focus cm 3 3 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the ...

Page 153: ...ormation prr Hz 668 9 pr at max lpi MPa 1 12 deq at max lpi cm 1 65 Ipa αat max MI W cm2 34 41 Operating Mode B M B M B M control Focus cm 4 7 5 3 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation ...

Page 154: ...tion prr Hz 668 9 pr at max lpi MPa 1 12 deq at max lpi cm 1 65 Ipa αat max MI W cm2 34 38 Operating Mode THI B M THI B M THI B M control Focus cm 4 7 5 3 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in r...

Page 155: ...formation prr Hz 6970 pr at max lpi MPa 3 17 deq at max lpi cm 0 27 Ipa αat max MI W cm2 179 38 Operating Mode PW PW PW control Focus cm 6 5 3 5 3 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation ...

Page 156: ...ion prr Hz 4854 pr at max lpi MPa 3 11 deq at max lpi cm Ipa αat max MI W cm2 90 12 Operating Mode B B control Focus cm 3 6 5 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the requir...

Page 157: ... necessary to enter data in the column relating to MI Acoustic power table System SonidoSmart Transducer model MC6 A Operating mode THI B Index sign MI TIS TIB TIC Scan No scan No scan Aaprt 1c m2 Aaprt 1c m2 Global maximum index value 0 6 0 1 Associated pra Mpa 1 49 acoustic P mW 20 parameters Min of Pα ZsIta α Zs mW Zs cm Zbp cm Zb cm Z at maxpi α cm 3 3 deq Zb cm fawf MHz 5 68 5 67 Attenuation ...

Page 158: ... Information prr Hz 400 pr at max lpi MPa 0 75 deq at max lpi cm 3 27 Ipa αat max MI W cm2 12 25 Operating Mode B M B M B M control Focus cm 3 5 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to...

Page 159: ...ormation prr Hz 400 pr at max lpi MPa 0 75 deq at max lpi cm 3 27 Ipa αat max MI W cm2 12 21 Operating Mode THI B M THI B M THI B M control Focus cm 3 5 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in rel...

Page 160: ... Information prr Hz 4000 pr at max lpi MPa 0 57 deq at max lpi cm 0 57 Ipa αat max MI W cm2 8 52 Operating Mode PW PW PW control Focus cm 5 5 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TI...

Page 161: ...on prr Hz 3831 pr at max lpi MPa 1 52 deq at max lpi cm Ipa αat max MI W cm2 61 29 Operating Mode B B control Focus cm 3 7 5 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the require...

Page 162: ...n prr Hz 3831 pr at max lpi MPa 1 14 deq at max lpi cm Ipa αat max MI W cm2 45 26 Operating Mode THI B THI B control Focus cm 3 7 5 conditions Output 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to TIC NOTE 3 If the ...

Page 163: ...formation prr Hz 4717 pr at max lpi MPa 2 72 deq at max lpi cm Ipa αat max MI W cm2 215 57 Operating Mode B M B M B M control Focus cm 6 5 0 5 6 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation to...

Page 164: ...on prr Hz 4717 pr at max lpi MPa 2 71 deq at max lpi cm 0 07 Ipa αat max MI W cm2 215 32 Operating Mode THI B M THI B M THI B M control Focus cm 6 5 0 5 6 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in r...

Page 165: ...rmation prr Hz 3424 7 pr at max lpi MPa 3 05 deq at max lpi cm 2 68 Ipa αat max MI W cm2 141 73 Operating Mode PW PW PW control Focus cm 5 5 2 5 4 5 conditions Output 100 100 100 NOTE 1 Data should only be entered in one of the columns relating to TIS NOTE 2 Information for the TRANSDUCER DEVICE that is not intended for trans cranial or neonatal brain applications may not be pro vided in relation ...

Page 166: ...delines and manufacturer s declaration electromagnetic immunity The SONIDOSMART is intended for use in the electromagnetic environment specified below The customer or user of the SONIDOSMART should ensure that it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic envi ronment Guidelines Electrostatic dis charge ESD in accordance with IEC 61000 4 2 6...

Page 167: ...ge quality must correspond to that of a typical commercial or hospi tal environment If the user of the SONIDOSMART requires continued functionality even in the case of interruptions to the power supply it is rec ommended that the SONIDOSMART be powered from an uninterruptible power supply or a battery Magnetic field at the supply fre quency 50 60 Hz in accordance with IEC 61000 4 8 3 A m 3 A m Mag...

Page 168: ...ion distance in metres m The field strengths of fixed RF transmitters as determined by an on site survey should for all frequencies be less than the compliance levela b Interferences are possible in the vicinity of devices marked with the following symbol NOTE 1 At 80 and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all cases Electromagnetic propagation is af...

Page 169: ...W Safety separation distance depending on the frequency of the transmitter m 150 KHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters whose maximum rated output is not specified in the above table the recommended safety separation distance d in metres m can be determined using th...

Page 170: ...ement Area of usage Accuracy meas Full screen 5 Scope Trace method ellipse method Full screen 5 Area Trace method ellipse method Full screen 10 Volume Full screen 10 Angle Full screen 5 Time Full screen 5 Heart rate Full screen 5 Velocity Full screen 10 ...

Page 171: ...play accuracy and measurement uncertainty for acoustic measurement are summarised in the following table The display accuracy of MI is 20 and TI is 40 or 0 1 if MI TI is below 0 5 Item Measurement uncertainty Percentage at 95 confidence limit Centre frequency 5 Acoustic power 30 Acoustic intensity 30 Peak rarefactional pressure 15 ...

Page 172: ...e transducer in contact with a simulated human tissue The calculation of the expanded uncertainty was carried out based on the ISO guideline for the expression of uncertainty in measurement Three transducer samples were tested and the confi dence limit is 95 the value of t 975 is 4 30 The measured data was obtained under the test conditions used by ZIMMER MEDIZINSYSTEME Transducer Model Maximum su...

Page 173: ...Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 7 31 97 61 291 Fax 49 7 31 97 61 299 export zimmer de www zimmer de Instructions for Use EN 10102699 TM 1217 I Version 1 I Subject to changes ...

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