Home

S Series Ultrasound System User Guide

1. 1 Insert the USB storage device See Inserting and removing USB storage devices on page 6 2 In the patient list select the patients whose images and clips you want to export 3 Select Exp USB on screen A list of USB devices appears 4 Select the USB storage device and select Export Only available USB devices for example not password protected are selectable The files are finished exporting approximately five seconds after the USB animation stops Removing the USB storage device or turning off the system while exporting may cause exported files to be corrupted or incomplete To stop in progress exporting select Cancel Export To delete images and clips 1 Select one or more patients in the patient list 2 Select Delete to delete the selected patients A confirmation screen appears Chapter 3 Imaging 31 32 You can perform distance area and circumference measurements in any imaging mode Measurements are performed on frozen images You can perform multiple measurements at one time up to eight distance measurements or four area circumference measurements or a combination for example six distance measurements and one area circumference measurement 20090ct18 09 58 t Back CER Jd 1 51cm B 0 56cm A 0 25cme C 1 77cm is Ub 150 X Delete Fr Figure 4 1 2D image with one distance and one circumference measurement When measuring you work with calipers Results based on the calipers position ap
2. EN 60601 1 2 2001 European Norm Medical Electrical Equipment General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests CISPR11 2004 International Electrotechnical Commission International Special Committee on Radio Interference Industrial Scientific and Medical ISM Radio Frequency Equipment Electromagnetic Disturbance Characteristics Limits and Methods of Measurement Chapter 7 Specifications 87 suone yi edsg The Classification for the ultrasound system stand accessories and peripherals when configured together is Group 1 Class A Airborne equipment standards RTCA DO 160E 2004 Radio Technical Commission for Aeronautics Environmental Conditions and Test Procedures for Airborne Equipment Section 21 0 Emission of Radio Frequency Energy Category B HIPAA standard The Health Insurance and Portability and Accountability Act Pub L No 104 191 1996 45 CFR 160 General Administrative Requirements 45 CFR 164 Security and Privacy 88 Glossary Terms For ultrasound terms not included in this glossary refer to Recommended Ultrasound Terminology Second Edition published in 1997 by the American Institute of Ultrasound in Medicine AIUM as low as reasonably achievable ALARA curved array transducer depth in situ LCD linear array transducer mechanical index MI MI TI NTSC PAL phased array The guiding principle of ultrasound
3. See Figure 1 1 on page 2 2 Connect the AC power cord to the power supply and to a hospital grade electrical outlet Turning the system on or off Caution Do not use the system if an error message appears on the display Note the error code and turn off the system Call SonoSite or your local representative To turn the system on or off Press the power switch See System controls on page 7 To wake up the system To conserve battery life while the system is on the system goes into sleep mode if untouched for a preset time To adjust the time for sleep delay see Audio Battery setup on page 18 Press a key or touch the touchpad Connecting transducers WARNING To avoid injury to the patient do not place the connector on the patient Operate the ultrasound system in the S Stand or on a convenient surface to allow air flow past the connector Caution To avoid damaging the transducer connector do not allow foreign material in the connector Figure 1 2 Connect the Transducer To connect a transducer 1 Pull the transducer latch up and rotate it clockwise 2 Align the transducer connector with the connector on the back of the system 3 Insert the transducer connector into the system connector 4 Turn the latch counterclockwise 5 Press the latch down securing the transducer connector to the system To remove a
4. Vesphene II USA Liquid Sodium A A A U o Phenylphenate Virex Il 256 USA Liquid Ammonium Chloride A A A U Virex TB USA Liquid Quat Ammonia A A N N Virox 5 CAN Wipe Hydrogen Peroxide A A A U Virufen FRA Liquid Alkyl Ammonium A A A U Chloride Wavicide 01 USA Liquid Gluteraldehyde N N N U Wavicide 06 USA Liquid Gluteraldehyde U Wex Cide USA Liquid O phenylphenol A A A U A Acceptable N Not acceptable Do not use U Untested Do not use Bunoouse qnoJ 50 Chapter 6 Safety This chapter contains information required by regulatory agencies including information about the ALARA as low as reasonably achievable principle the output display standard acoustic power and intensity tables and other safety information The information applies to the ultrasound system transducer accessories and peripherals Ergonomic safety These healthy scanning guidelines are intended to assist you in the comfort and effective use of your ultrasound system WARNING To prevent musculoskeletal disorders follow the guidelines in this section Use of an ultrasound system may be linked to musculoskeletal disorders Use of an ultrasound system is defined as the physical interaction among the operator the ultrasound system and the transducer When using an ultrasound system as with many similar physical activities you may experience occasional discomfort in your hands fingers arms shoulders eyes back or other parts of
5. All Delete Done Figure 3 1 Patient List To open the patient list 1 In 2D press Patient 2 Press Review 3 If there is a current patient press List To sort the patient list After the system starts the patient list is arranged by date and time with the most recent patient file first You can re sort the patient list as needed Click the column heading that you want to sort by Click it again if sorting in reverse order Note The selection column w is sortable To select patients in the patient list Select the check box for one or more patients Clicking Select All selects all patients To deselect patients clear checked boxes or click Clear All Chapter 3 Imaging 29 To review images and clips You can review only one patient s images and clips at a time 1 In the patient list click the patient whose images and clips you want to review The patient row is highlighted N Press the Review knob The icon on the knob changes to two numbers the file displayed and the total files saved w Turn the knob to cycle to the image or clip you want to review A Clip Only Press the Play key The clip plays automatically after loading The load time depends on clip length You can press the Pause key to freeze the clip and can turn the right hand knob for a playback speed 5 Turn the left hand knob x x to cycle to the next image or clip you want to view To return to the patient lis
6. Handle transducer with care Type BF patient applied part B body F floating applied part Underwriter s Laboratories labeling Table 16 Labeling Symbols Continued Definition n lt Jg 9 0 6 WARNING Connect Only Accessories and Peripherals Recommended by SonoSite Pollution Control Logo Applies to all parts products listed in the China RoHS disclosure table May not appear on the exterior of some parts products because of space limitations China Compulsory Certificate mark CCC Mark A compulsory safety mark for compliance to Chinese national standards for many products sold in the People s Republic of China Contains mercury Applies to the LCD and may apply to other components in the ultrasound system WARNING Connect Only Accessories and Peripherals Recommended by SonoSite Chapter 6 Safety 83 Ayayes 84 Chapter 7 Specifications This chapter contains system and accessory specifications and standards The specifications for recommended peripherals are in the manufacturers instructions Supported transducers C11x 8 5 MHz 6 ft 1 8 m e L25x 13 6 MHz 7 5 ft 2 3 m e C60x 5 2 MHz 5 5 ft 1 7 m e 38x 10 5 MHz 5 5 ft 1 7 m HFL38x 13 6 MHz 5 6 ft 1 7 m e P21x 5 1 MHz 6 ft 1 8 m e ICTx 8 5 MHz 5 5 ft 1 7 m Imaging modes 2D 256 gray shades Color Doppler Color 256 colors Color power Doppler CPD 256 colors Images and clips
7. Section 6 4 of the Output Display Standard the following measurement precision and uncertainty values are determined by making repeat measurements and stating the standard deviation as a percentage Table 15 Acoustic Measurement Precision and Uncertainty Quantity Pr Pr Wo fc Precision Uncertainty of standard deviation 95 confidence 1 9 11 2 1 9 12 2 3 4 10 0 1 4 7 Chapter 6 Safety 79 Ayayes Table 15 Acoustic Measurement Precision and Uncertainty Continued Quantit Precision Uncertainty y 96 of standard deviation 95 confidence PII 3 2 12 5 to 16 8 PII 4 3 296 413 47 to 17 5 Labeling symbols The following symbols are used on the products packaging and containers Table 16 Labeling Symbols Symbol Definition Alternating Current AC Pa g Class 1 device indicating manufacturer s declaration of conformance with C C Annex VII of 93 42 EEC Class 1 device requiring verification by the Notified Body of sterilization or C measurement features or to a Class lla IIb or IIl device requiring verification or 0008 auditing by the Notified Body to applicable Annex es of 93 42 EEC Attention see the user guide Device complies with relevant Australian regulations for electronic devices p Batch code date code or lot code type of control number ON Biological risk V Device complies with relevant Brazilian regulations for electro medical devices Canadia
8. The USB storage device is ready when the USB icon appears To view information about the device see USB Devices setup on page 20 To remove a USB storage device Removing the USB storage device while the system is exporting may cause the exported files to be corrupted or incomplete 1 Wait five seconds after the USB animation stops 2 Remove the USB storage device from the port System controls Figure 1 3 System Controls 1 Power switch 2 Control keys 3 Control knobs 4 Touchpad 5 Touchpad key Turns the system on and off Perform an action or make a selection based on context Current names appear on screen adjacent to the keys Adjust gain depth cine buffer ROI box and brightness Sometimes perform an action Are turned or pressed Moves the pointer and other items Works in conjunction with the touchpad Is pressed to activate an item on screen Chapter 1 Getting Started panes buia Screen layout 123456789 2010Feb06 00 32 Saami 200 Ellipse ze Calipers T 7 Print A LT COMMON CAROTID ARTERY Figure 1 4 Screen Layout 1 Mode Data Area Current imaging mode information for example Gen S THI S and THI are on when available on the transducer and are not user controlled For definitions see Glossary 2 Orientation Marker Provides indication for image orientation 3 Image Ultrasound image 4 Measurement Data Curr
9. Wipes DEU Wipe Ethanol Propanol A A A U Nuclean FRA Spray Alcohol Biguanide A A A U Precise USA Spray O phenylphenol N N N U Prevention CAN Liquid Hydrogen Peroxide N N N U Buljooysajqnoly 8v Table 1 Disinfectants Compatible with System and Transducers Continued Cleaning Solutions of Origin PE Adiveingrede Depar HFL38x ask Surfaces Ruthless USA Spray Quat Ammonia A A N U Sagrosept Wipe DEU Wipe Propanol A A A U Salvanios pH 7 FRA Liquid Quat Ammonia A A A U Sani Cloth HB USA Wipe Quat Ammonia A A N A Sani Cloth Plus USA Wipe Quat Ammonia A A A A Sekusept DEU Liquid Gluteraldehyde A A A U Sklar USA Liquid Isopropanol A A N U Sporicidin USA Liquid Phenol A A A N Sporicidin Wipes USA Wipe Phenol A A A A Staphene USA Spray Ethanol A N A U Steranios FRA Liquid Gluteraldehyde A A A U Super Sani Cloth USA Wipe Isopropyl Alcohol N N N N T Spray USA Spray Quat Ammonia A A N N T Spray II USA Spray Alkyl Chloride A A A U TASK 105 USA Spray Quat Ammonia A A A U TBQ USA Liquid Quat Ammonia A A A U Theracide Plus USA Liquid Quat Ammonia A A A U Theracide Plus USA Wipe Quat Ammonia A A A A Wipes Tor USA Liquid Quat Ammonia A A N U e ueuajurey pue 6unoouse gnoJ 4aydeyD 6v Table 1 Disinfectants Compatible with System and Transducers Continued aeania Onn Te Acivelngredtnt or Wa ur em Transeptic USA Cleaner Alcohol N N N U Tristel GBR Liquid Chlorine Dioxide A A A U Tristel Wipes GBR Wipe Chlorine Dioxide N N N N
10. application These criteria include biocompatability requirements The transducer you use determines which exam types are available In addition the exam type you select determines which imaging modes are available To change the exam type Do one of the following In 2D imaging press Exam and then click the exam type in the menu On the patient information form click the exam type in the Exam list See Patient information form on page 27 24 Imaging modes and exams available by transducer Imaging Mode Transducer Exam S seres 2D CPD Color Type System C11x Nrv S Nerve X X X Vas S Nerve X X X C60x Abd S Cath X X X S FAST S ICU Nrv S Nerve X X X HFL38x Bre S Cath X X X Nrv S Nerve X X X SmP S Cath X X X S FAST S ICU Vas S Cath X X X S FAST S ICU S Nerve Ven S Cath X X X S FAST S ICU ICTx Gyn S FAST X X X OB S FAST X X X Chapter 3 Imaging 25 Buibeui 26 Imaging modes and exams available by transducer Continued Imaging Mode Transducer Exam acie 2D CPD Color Type System L25x Nrv S Nerve X X X Sup S Cath X X X Vas S Cath X X X S ICU S Nerve Ven S Cath X X X S ICU L38x Bre S Cath X X X Nrv S Nerve X X X SmP S Cath X X X S FAST S ICU Vas S Cath X X X S FAST S ICU S Nerve Ven S Cath X X X S FAST S ICU P21x Abd S Cath X X X S FAST S ICU Crd S FAST X X S ICU 1 Exam type abbreviations are as follows Abd Abdomen Bre Breast Crd Card
11. artifact and improve resolution on the 2D image Understanding the nature of the imaging mode used allows the qualified ultrasound user to apply the ALARA principle Prudent use of ultrasound requires that patient exposure to ultrasound be limited to the lowest ultrasound output for the shortest time necessary to achieve acceptable diagnostic results Decisions that support prudent use are based on the type of patient exam type patient history ease or difficulty of obtaining diagnostically useful information and potential localized heating of the patient due to transducer surface temperature The system has been designed to ensure that temperature at the face of the transducer will not exceed the limits established in Section 42 of EN 60601 2 37 Particular requirement for the safety of ultrasound medical diagnostic and monitoring equipment See Transducer surface temperature rise on page 68 In the event of a device malfunction there are redundant controls that limit transducer power This is accomplished by an electrical design that limits both power supply current and voltage to the transducer The sonographer uses the system controls to adjust image quality and limit ultrasound output The system controls are divided into three categories relative to output controls that directly affect output controls that indirectly affect output and receiver controls Direct controls The system does not exceed a spatial peak temporal average i
12. assure that it is sufficiently low Portable and mobile RF communications equipment should be used no closer to any part of the SonoSite ultrasound system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d 1 2 P d 1 2P 80 MHz to 800 MHz d 2 3 JP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Chapter 6 Safety 61 Ayayes Table 2 Manufacturer s Declaration Electromagnetic Immunity Continued Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Radiated RF Field strengths from fixed RF IEC 61000 4 3 transmitters as determined by an electromagnetic Site survey should be less than the compliance level in each frequency range continued Interference may occur in the vicinity of equipment marked with the following symbol IEC 60417 No 417 IEC 5140 Source of non ionizing radiation Note Ur is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fi
13. cm o 2 Control 1 Mode CPD E g Control 2 Exam Type Vas 2 E Control 3 PRF 2841 O O Control 4 Optimization Depth Med 2 0 Control 5 Color Box Top Position Size Short 72 a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Table 9 Transducer Model C60x 5 2 Operating Mode 2D TIS TIB Index Label M I Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 0 a b Pr3 MPa 1 59 Wo mW 3 5 Z cm E Zpp cm fS 5 Zsp cm 53 3 8 d so cm i fc MHz 2 86 Dim of Aaprt X cm Y cm PD usec 0 579 PRF Hz 7923 e p PII max MPa 2 679 9 deg Pllmax cm c Focal Length FL cm ENE zu oO 2C 5 FL cm _ lpa 3 M max W cm 197 7 o 2 Control 1 Exam Type Any Control 2 Optimization Pen 9 Control 3 Depth 6 6 cm OUS O Q Control 4 THI On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neon
14. distance measurement components have the accuracy and range shown in the following tables Chapter 4 Measurements 35 sjueulaJnseaIw Table 1 2D Measurement Accuracy and Range 2D Measure Accuracy and Range System Tolerance Accuracy By Test Method Range cm Axial Distance Lateral Distance Diagonal Distance Area Circumference a Full scale for distance implies the maximum depth of the image lt 2 plus 1 of full scale lt 2 plus 1 of full scale lt 2 plus 1 of full scale 4 plus 2 of full scale smallest dimension 100 plus 0 596 3 plus 1 496 of full scale smallest dimension 100 plus 0 596 Acquisition Acquisition Acquisition Acquisition Acquisition Phantom Phantom Phantom Phantom Phantom b An RMI 413a model phantom with 0 7 dB cm MHz attenuation was used c The area accuracy is defined using the following equation 96 tolerance 1 lateral error 1 axial error 1 100 0 596 0 26 cm 0 35 cm 0 44 cm 0 01 720 cm 0 01 96 cm d The circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following equation 96 tolerance 4 2 maximum of 2 errors 100 0 596 Sources of measurement errors 36 In general two types of errors can be introduced into the measurement Acquisition Error Includes errors introduced by the ultrasound system electronics
15. instructions see Chapter 5 Troubleshooting and Maintenance Do not submerge the transducer connector in solution The cable is not liquid tight beyond the transducer connector cable interface Do not use solvents such as thinner or benzene or abrasive cleaners on any part of the system Remove the battery from the system if the system is not likely to be used for some time Do not spill liquid on the system Battery safety To prevent the battery from bursting igniting or emitting fumes and causing personal injury or equipment damage observe the following precautions WARNING 56 The battery has a safety device Do not disassemble or alter the battery Charge the batteries only when the ambient temperature is between 0 and 40 C 32 and 104 F Do not short circuit the battery by directly connecting the positive and negative terminals with metal objects Do not heat the battery or discard it in a fire Do not expose the battery to temperatures over 60 C 140 F Keep it away from fire and other heat sources Do not charge the battery near a heat source such as a fire or heater Do not leave the battery in direct sunlight Do not pierce the battery with a sharp object hit it or step on it Do not use a damaged battery Do not solder a battery The polarity of the battery terminals are fixed and cannot be switched or reversed Do not force the battery into the system Do not connect the bat
16. method 1 Remove the battery from the system 2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution Apply the solution to the cloth rather than the surface 3 Wipe the surfaces with the disinfection solution Theracide disinfectant is recommended 4 Air dry or towel dry with a clean cloth Chapter 5 Troubleshooting and Maintenance 43 BHuljooysajqnoly by CE approval Table 1 does not have the following regulatory information for disinfectants EPA Registration FDA 510 k clearance liquid sterilant high level disinfectant Prior to use confirm that the regulatory status of the disinfectant is appropriate for your jurisdiction and use See www sonosite com for updated cleaning and disinfectant information Click Quick Link and then click Documentation Table 1 Disinfectants Compatible with System and Transducers oinean Onin Pe Activelngredint CSUN Waa Co Set AbcoCide 14 USA Liquid Gluteraldehyde A A A U Accel Wipes CAN Wipe Hydrogen Peroxide A A A U Accel Plus CAN Wipe Hydrogen Peroxide N N N U Accel TB CAN Wipe Hydrogen Peroxide N N N U Aidal Plus AUS Liquid Gluteraldehyde A A A U Alkacide FRA Liquid Gluteraldehyde A A A U Alkazyme FRA Liquid Quat Ammonia A A A U Anioxy Twin FRA Liquid Peracetic Acid N N N U Aquatabs 1000 IRL Tablet Sodium A N A U Dichloroisocyanurate Aquatabs 2000 IRL Tablet Sodium A N A U Dichloroisocyanurate e ueuajurey p
17. more concentrated exposure than a scanned beam which spreads that exposure over that area The transducer capability depends upon the frequency penetration resolution and field of view The default system presets are reset at the start of each new patient It is the scanning technique of the qualified ultrasound user along with patient variability that determines the system settings throughout the exam The variables which affect the way the qualified ultrasound user implements the ALARA principle include patient body size location of the bone relative to the focal point attenuation in the body and ultrasound exposure time Exposure time is an especially useful variable because the qualified ultrasound user can control it The ability to limit the exposure over time supports the ALARA principle Applying ALARA The system imaging mode selected by the qualified ultrasound user is determined by the diagnostic information required 2D imaging provides anatomical information CPD imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location and is used for detecting the presence of blood flow Color imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location and is used for detecting the presence velocity and direction of blood flow Tissue Harmonic Imaging uses higher received frequencies to reduce clutter
18. multiple systems and back up user account information To export user accounts 1 Insert a USB storage device 2 Log in as Administrator 3 Press Export A list of USB devices appears 4 Click the USB storage device and click Export All user names and passwords are copied to the USB storage device To import user accounts 1 Insert the USB storage device that contains the accounts 2 Log in as Administrator 3 Press Import 4 Click the USB storage device and click Import 5 Click Done in the dialog box that appears The system restarts All user names and passwords on the system are replaced with the imported data Exporting and clearing the Event log The Event log collects errors and events and can be exported to a USB storage device and read ona PC To view the Event log 1 Log in as Administrator 2 Press Log The Event log appears To return to the previous screen press Back To export the Event log The Event log has the file name log txt Exporting the Event log to a USB storage device overwrites any existing log txt file 1 Insert a USB storage device 2 Press Log and then press Export A list of USB devices appears 3 Click the USB storage device and click Export The Event log is a text file that you can open in a text editing application for example Microsoft Word or Notepad To clear the Event log 1 View the Event log 2 Press Clear 3 Click Yes Logging in as user If user login is required the Us
19. of an invasive or surgical nature Do not apply the transducer sheath and gel until you are ready to perform the procedure Caution Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Chapter 5 Troubleshooting and Maintenance 39 BHuljooysajqnoly Cleaning and disinfecting the ultrasound system The exterior surface of the ultrasound system and the accessories can be cleaned and disinfected using a recommended cleaner or disinfectant See Table 1 Disinfectants Compatible with System and Transducers on page 44 WARNING Caution To avoid electrical shock before cleaning disconnect the system from the power supply or remove it from the stand To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures To avoid infection ensure that the solution expiration date has not passed To avoid infection the level of disinfection required for a product is dictated by the type of tissue it contacts during use Ensure that the solution strength and duration of contact are appropriate for the equipment For information see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology APIC and FDA Do not spray cleaners or disinfectant directly on the syste
20. relating to signal acquisition signal conversion and signal processing for display Additionally computational and display errors are introduced by the generation of the pixel scale factor application of that factor to the caliper positions on the screen and the measurement display Algorithmic Error The error introduced by measurements which are input to higher order calculations This error is associated with floating point versus integer type math which is subject to errors introduced by rounding versus truncating results for display of a given level of significant digit in the calculation Chapter 5 Troubleshooting and Maintenance This chapter contains information to help correct problems with system operation to enter a software license and to take proper care of the system transducer and accessories Troubleshooting If you encounter difficulty with the system use the following table to help troubleshoot the problem If the problem persists contact SonoSite Technical Support See SonoSite Technical Support on page viii Troubleshooting Symptom Solution System does not turn on System image quality is poor No CPD image No Color image Print does not work DVD recorder does not record System does not recognize the transducer A maintenance icon appears on the system screen Check all power connections Remove the DC input connector and battery wait 10 seconds and then reinstall
21. them Ensure that the battery is charged Adjust the LCD screen to improve viewing angle Adjust the brightness Adjust the gain Adjust the gain Adjust the gain or the scale Select the printer on the Connectivity setup page See To configure the system for a printer on page 18 Check the printer connections Ensure that the printer is turned on and set up properly See the printer manufacturer s instructions if necessary Check the DVD recorder connections Ensure that the DVD recorder is turned on and set up properly See the applicable SonoSite accessory user guide and the manufacturers instructions Disconnect and reconnect the transducer System maintenance may be required Record the number in parentheses on the C line and contact SonoSite or your SonoSite representative Chapter 5 Troubleshooting and Maintenance 37 BHuljooysajqnoly Software licensing 38 SonoSite software is controlled by a license key After you install new software the system prompts you for a license key You must obtain one key for each system or transducer that uses the software The software will operate for a short time the grace period without a license key During the grace period all system functions are available After the grace period the system is not usable until you enter a valid license key Grace period time is not used while the system is off or asleep Grace period time remaining appears on the licens
22. use which states that you should keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results Identified by the letter C curved or curvilinear and a number 60 The number corresponds to the radius of curvature of the array expressed in millimeters The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam For example C15 C60e Refers to the depth of the display A constant speed of sound of 1538 5 meters second is assumed in the calculation of echo position in the image In the natural or original position liquid crystal display Identified by the letter L linear and a number 38 The number corresponds to the radius of width of the array expressed in millimeters The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam For example L38 An indication of the likelihood of mechanical bioeffects occurring the higher the MI the greater the likelihood of mechanical bioeffects See Chapter 6 Safety for a more complete description of MI See mechanical index MI and thermal index TI National Television Standards Committee A video format setting See also PAL Phase Alternating Line A video format setting See also NTSC A transducer designed primarily for cardiac scanning Forms a sector image by electronically steering the beam direction and focus G
23. uses 11 cautions definition vii cine buffer 23 clean battery 43 LCD screen 40 system 40 transducers 41 click 9 clips length 19 See also images and clips color Doppler Color imaging 22 color power Doppler CPD imaging 22 Color See color Doppler Color imaging connectivity setup 18 symbols 3 control keys 8 9 controls direct 63 indirect 64 receiver 64 CPD See color power Doppler CPD imaging customer assistance vii D date 19 default settings 13 depth adjust 23 definition 89 marker 8 19 disinfect battery 43 system 40 transducers 41 disinfectants compatibility 44 display brightness 19 distance measurements 34 DVD recorder 18 37 E electrical safety 53 specifications 87 electromagnetic compatibility 58 electromechanical safety standards 87 Ellipse 35 EMC classification standards 87 equipment safety 56 error message 55 Index 93 xopu 94 errors acquisition 36 algorithmic 36 measurement 36 Event log 16 exam end 27 type and transducer 25 type change 24 export Event log 16 images and clips 31 USB Devices setup 20 user accounts 16 F focal zones optimize 22 freeze 23 G gain adjust 23 Auto Gain 21 grace period 38 guidance documents related 67 Guide 24 guidelines 24 gynecology intended uses 11 H HIPAA standard 88 humidity limits 86 image quality poor 37 images and clips delete 31 export to USB 31 review 30 save 28 imaging modes list of 85 tra
24. your peripherals No periodic or preventive maintenance is required for the system transducer or accessories other than cleaning and disinfecting the transducer after every use See Cleaning and disinfecting transducers on page 41 There are no internal components that require periodic testing or calibration All maintenance requirements are described in this chapter and in the ultrasound system service manual Performing maintenance procedures not described in the user guide or service manual may void the product warranty Contact SonoSite Technical Support for any maintenance questions See SonoSite Technical Support on page viii WARNING Disinfectants and cleaning methods listed are recommended by SonoSite for compatibility with product materials not for biological effectiveness Refer to the disinfectant label instructions for guidance on disinfection efficacy and appropriate clinical uses The level of disinfection required for a device is dictated by the type of tissue it will contact during use To avoid infection ensure that the disinfectant type is appropriate for the equipment For information see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology APIC and the U S Food and Drug Administration FDA To prevent contamination the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications
25. 1 c E Z cm 3 2 Zbp cm fS 5 Zsp cm 4 5 8 diaz cm lt fe MHz 2 15 2 16 Dim of Aaprt X cm 0 918 Y cm 1 3 PD usec 1 20 S PRF HzZ 1063 E pr Pll mnax MPa 2 574 9 deqg Pll max cm Focal Length FL cm 3 68 uU e ex 8 FL cm 5 5 lp 3 M max W cm 330 4 Control 1 Mode Color CPD v Control 2 Exam Type Abd Oo t95 OB QB S S 5 Control 3 PRF Depth 300 10 850 75 J S Control 4 Color Optimization Any Med Control 5 THI On Off Control 6 Color Box Size Short and Any Narrow a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Chapter 6 Safety 77 Ayayes Terms used in the acoustic output tables 78 Table 14 Acoustic Output Terms and Definitions Term Definition Ispra 3 Derated spatial peak temporal average intensity in units of milliwatts cm TI type Applicable thermal index for the transducer imaging mode and exam type TI value Thermal index value for the transducer imaging mode and exam type MI Mechanical index Iba 3 MImax Derated pulse average inte
26. 59 Turning the system on or off sss 4 Connecting transducers essen 5 Inserting and removing USB storage devices sss 6 ky ihoEeenligegt c 7 Sereen yell 8 crucis 9 Touchpad eie tette ree tes tee EHI R 9 ioi 9 Entering text a9 Preparing transducers cessssssscssscccsssccsesesssescsssscsssssesssscsssssesssscesssesssesecsnseesneeeeneeses 10 WATE USES eni orte A A AA 11 Chapter 2 System Setup Displaying the setup pages sesscssssscssesecssescssscecssescsssccsssesesssescssseessseecsseeesseeeeneeees 13 Restoring default settings csseccssssssssecsssessssescsseccsssessssesssssesssssesssscsssnecsssnecesseeses 13 Administration setup 14 Eis elsed autas 14 User Set p ciet netten teo erectos wel Exporting or importing user accounts ou sscsescseecseeesseecssessseeesesesesenseesses 16 Exporting and clearing the Event log sees 16 Logging in as User eee esesseeeeen tenentes tentent tonto neto tent ttastnttnas 17 Choosing a secure password essesssssesssesssecssecsssccssccssccssecessecssccssccessecsueesseesss 17 Audio Battery setup seescsesscssseccssessssteccsseecssscesuseccsucesuseecssscessseccuseecsuseccuseeesseeesnsees 18 Moizsdii i 18 Date and ME TET eiiieaenii estiis 19 Display Information setup sssss
27. 7 EMC classification 87 HIPAA 88 storage specifications equipment 86 images 85 superficial intended uses 12 symbols connectivity 3 labeling 80 system clean and disinfect 40 controls 7 software 1 status 8 wake up 4 7 Technical Support viii temperature limits 86 text enter 9 thermal index TI 19 67 90 time setup 19 tissue models 70 touchpad 9 transducer clean and disinfect 41 connect 5 curved array 89 definition 90 disinfect 41 exam type 25 general use 10 imaging modes 25 invasive or surgical use 10 linear array 89 preparation 10 problems 37 sheath 10 specifications 85 troubleshoot 37 Index 95 xopu 96 U ultrasound terminology 89 USB export 20 31 insert or remove device 6 port 3 user accounts 16 user guide conventions used vii user setup 15 uses intended 11 V vascular intended uses 12 video 3 WwW warnings definition vii Z zoom 24 Index BSonoSite P07525 01 HARI ARATRI
28. Amendment 1 The limit is a 6 C rise from ambient as measured on the TMM The ambient temperature shall be 23 C 3 C Table 6 Transducer Surface Temperature Rise EN 60601 2 37 External Use Test C11x C60x HFL38x L25x L38x P21x 1 9 2 C 9 0 C 9 5 C 9 5 C 9 6 C 9 0 C 2 19 0 C 18 0 C 19 0 C 18 2 C 20 0 C 20 0 C Table 7 Transducer Surface Temperature Rise IEC 60601 2 37 Internal Use Test ICTx 3 5 5 C 2 12 0 C Acoustic output measurement Since the initial use of diagnostic ultrasound the possible human biological effects bioeffects from ultrasound exposure have been studied by various scientific and medical institutions In October 1987 the American Institute of Ultrasound in Medicine AIUM ratified a report prepared by its Bioeffects Committee Bioeffects Considerations for the Safety of Diagnostic Ultrasound J Ultrasound Med Sept 1988 Vol 7 No 9 Supplement sometimes referred to as the Stowe Report which reviewed available data on possible effects of ultrasound exposure Another report Bioeffects and Safety of Diagnostic Ultrasound dated January 28 1993 provides more current information The acoustic output for this ultrasound system has been measured and calculated in accordance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD2 2004 and the Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasou
29. American Society of Echocardiography May1997 357 362 d Wihlidal L M and S Kumar An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta International Journal of Industrial Ergonomics 19 1997 205 216 Chapter 6 Safety 51 Ayayes e Habes D J and S Baron Health Hazard Report 99 0093 2749 University of Medicine and Dentistry of New Jersey 1999 f Vanderpool H E E A Friis B S Smith and K L Harms Prevalence of Carpal Tunnel Syndrome and Other Work related Musculoskeletal Problems in Cardiac Sonographers Journal of Medicine 35 6 1993 605 610 Position the system Promote comfortable shoulder arm and hand postures Use a stand to support the weight of the ultrasound system Minimize eye and neck strain When the exam or procedure allows position the system within reach Adjust the angle of the system and display to minimize glare from overhead or outside lighting If using a stand adjust its height so that the display is at or slightly below eye level Position yourself 52 Support your back during an exam Usea chair that has support for your lower back that adjusts to your work surface height that promotes a natural body posture and that allows for quick height adjustments Always sitor stand in an upright manner Avoid bending or stooping Minimize reaching and twisting Use a bed that is height adjustable Position the patient as close to you as poss
30. Connection of accessories and peripherals not recommended by SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite See the SonoSite accessories user guide Electrostatic discharge ESD or static shock is a naturally occurring phenomenon ESD is common in conditions of low humidity which can be caused by heating or air conditioning Static shock is a discharge of the electrical energy from a charged body to a lesser or non charged body The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system The following precautions can help reduce ESD anti static spray on carpets anti static spray on linoleum and anti static mats Table 1 and Table 2 document the intended use environment and EMC compliance levels of the system For maximum performance ensure that the system is used in the environments described in this table The system is intended for use in the electromagnetic environment specified below Table 1 Manufacturer s Declaration Electromagnetic Emissions Emissions Test Compliance X Electromagnetic Environment RF emissions Group 1 The SonoSite ultrasound system uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any in
31. S Series Ultrasound System User Guide CE 61 Sonosite S Series Ultrasound System User Guide SonoSite Inc 21919 30th Drive SE Bothell WA 98021 USA T 1 888 482 9449 or 1 425 951 1200 F 1 425 951 1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 0AP UK T 44 1462 444800 F 44 1462 444801 Caution Federal United States law restricts this device to sale by or on the order of a physician S Cath S FAST S ICU S Nerve SiteLink SonoHD SonoMB and SonoSite are registered trademarks or trademarks of SonoSite Inc Non SonoSite product names may be trademarks or registered trademarks of their respective owners Protected by U S patents 5722412 5817024 5893363 6135961 6364839 6371918 6383139 6416475 6471651 6569101 6648826 6962566 7169108 Patents pending P07525 01 11 2007 Copyright 2007 by SonoSite Inc All rights reserved Contents Introduction CONVENTIONS cosciente aiat I M R vii Customer COMMENTS siinsesse E ede be eere eroe si vii Chapter 1 Getting Started Abot t the SVSteln 1c teecretn reete HERE eH EDEN HUP EUER Re EReUS THERE LE RK uod 1 Preparing the Systelm ccepit riri rere eee eirese ee Fer th e uel tikia 1 Compartments and connectors sssscccssesscccsseseccssseececssececssseeecesssesesssnseeseesees 1 Installing or removing the battery cseccssecsseccseccssecseecsssesseesseesseeeseecsseese 3 Using AC power and charging the battery 2
32. USB Devices setup page click Export 2 Under SiteLink select an image format For JPEG image format also select a JPEG compression A high compression has a smaller file size but less detail 3 Click a sort order under Sort By The sort order specifies how exported files are organized To return to the previous screen click Devices Chapter 3 Imaging Imaging modes The system has a high performance LCD and advanced image optimization technology that greatly simplifies user controls Imaging modes available depend on the transducer and exam type See Imaging modes and exams available by transducer on page 24 2D imaging 2D is the system s default imaging mode The system displays echoes in two dimensions by assigning a brightness level based on the echo signal amplitude To achieve the best possible image quality properly adjust the display brightness gain depth settings viewing angle and exam type Also use an optimization setting that best matches your needs To display the 2D image 1 Do any of the following Turn on the system Press 2D 2 Adjust settings See 2D settings 2D settings In 2D imaging the following control keys adjust settings See also Adjusting depth and gain on page 23 2D settings Control key Icon Description Auto Gain The gain adjusts each time you press the key To adjust gain manually see Adjusting depth and gain on page 23 Brightness Adjusts the display bright
33. a sample population of systems and transducers taken from early production units and they are selected based on having an acoustic output that is representative of the nominal expected acoustic output for all transducer system combinations that might occur Of course every transducer system combination has its own unique characteristic acoustic output and will not match the nominal output on which the display estimates are based This variability between systems and transducers introduces an error into displayed value By doing acoustic output sampling testing during production the amount of error introduced by the variability is bounded The sampling testing ensures that the acoustic output of transducers and systems being manufactured stays within a specified range of the nominal acoustic output Another source of error arises from the assumptions and approximations that are made when deriving the estimates for the display indices Chief among these assumptions is that the acoustic output and thus the derived display indices are linearly correlated with the transmit drive voltage of the transducer Generally this assumption is very good but it is not exact and thus some error in the display can be attributed to the assumption of voltage linearity Related guidance documents Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers FDA 1997 Medical Ultrasound Safety American Institute
34. alth information are required by the Health Insurance Portability and Accountability Act HIPAA of 1996 and the European Union Data Protection Directive 95 46 EC to implement appropriate procedures to ensure the integrity and confidentiality of information to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information Security settings on the system allow you to meet the applicable security requirements listed in the HIPAA standard Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected stored reviewed and transmitted on the system To log in as Administrator 1 Onthe Administration setup page type Administrator in the Name box See Entering text on page 9 2 Type the administrator password in the Password box If you don t have the administrator password contact SonoSite See SonoSite Technical Support on page viii 3 Click Login To log out as Administrator Turn off or restart the system To require user login You can set the system to display the User Login screen at startup 1 Log in as Administrator 2 In the User Login list click On On requires a user name and password at startup Off allows access to the system without a user name and password To change the administrator password or let users change passwor
35. ame number appear in the system status area To move forward or backward in the cine buffer On a frozen image turn the cine knob 411 The total number of frames appears next to the cine icon The number changes to the current frame number as you move forward or backward Chapter 3 Imaging 23 To zoom in on an image You can freeze or unfreeze the image or change the imaging mode at any time while zooming 1 Press Zoom A ROI box appears 2 Using the touchpad position the ROI box as desired 3 Press Zoom again The image in the ROI box is magnified by 100 4 Optional If the image is frozen use the touchpad to pan the image up down left and right To exit zoom press Zoom again Turning guidelines on and off Guidelines are for needle guidance and are an optional feature To turn guidelines on or off On a 2D image press one of the following control keys Biopsy 9 This feature depends on transducer type For more information see SonoSite Biopsy User Guide Guide This feature depends on transducer and exam type For more information see SonoSite Bracket and Needle Guide User Guide Imaging modes and exams available by transducer WARNING To prevent misdiagnosis or harm to the patient understand your system s capabilities prior to use The diagnostic capability differs for each transducer exam type and imaging mode In addition transducers have been developed to specific criteria depending on their physical
36. anical index MI is stated statistically With 90 confidence 90 of the measured MI values will be within 16 to 31 of the displayed MI value or 0 2 of the displayed value whichever value is larger The accuracy result for the thermal index TI is stated statistically With 90 confidence 90 of the measured TI values will be within 26 to 50 of the displayed TI value or 0 2 of the displayed value whichever value is larger The values equate to 1dB to 3dB A displayed value of 0 0 for MI or TI means that the calculated estimate for the index is less than 0 05 Factors that contribute to display uncertainty The net uncertainty of the displayed indices is derived by combining the quantified uncertainty from three sources measurement uncertainty system and transducer variability and engineering assumptions and approximations made when calculating the display values Measurement errors of the acoustic parameters when taking the reference data are the major source of error that contributes to the display uncertainty The measurement error is described in Acoustic measurement precision and uncertainty on page 79 The displayed MI and TI values are based on calculations that use a set of acoustic output measurements that were made using a single reference ultrasound system with a single reference transducer that is representative of the population of transducers of that type The reference system and transducer are chosen from
37. are explained in Chapter 1 Chapter 6 and Glossary Customer comments Questions and comments are encouraged SonoSite is interested in your feedback regarding the system and the user guide Please call SonoSite at 888 482 9449 in the US Outside the US call the nearest SonoSite representative You can also e mail SonoSite at comments sonosite com Introduction vii uon npoanu viii For technical support please contact SonoSite as follows SonoSite Technical Support Phone US or Canada Phone Outside US and Canada Fax E mail Web site Europe Service Center 877 657 8118 425 951 1330 Or call your local representative 425 951 6700 service sonosite com www sonosite com Click Support amp Service 44 0 1462 444 800 e mail uk service sonosite com Chapter 1 Getting Started About the system The SonoSite S Series ultrasound system is a portable software controlled device using all digital architecture The S Series includes the S Cath ultrasound system S FAST ultrasound system S ICU ultrasound system and the S Nerve ultrasound system The system has multiple configurations and feature sets used to acquire and display high resolution real time ultrasound images Features available on your system depend on system configuration transducer and exam type A license key is required to activate the software See Software licensing on page 38 On occasion a software upgrade may b
38. atal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Chapter 6 Safety 73 Ayayes Table 10 Transducer Model HFL38x 13 6 Operating Mode CPD Color TIS TIB Index Label M Non scan Non TIC Scan AaprtS1 Aapre gt 1 Scan Global Maximum Index Value 1 1 1 0 b Pr3 MPa 2 556 Wo mW 53 49 min of W 3 zi lrA 3 24 mW 3 5 Z cm E Zpp cm E 5 Zsp cm 12 em 8 dio cm 55 fe MHz 5 328 5 324 Dim of Aaprt X cm 0 44 Y cm 0 4 PD usec 0 525 S PRF Hz 2597 s pr Pll max MPa 3 187 OS deg Pllmax cm Focal Length FL cm 1 32 Qq cos 8 FLy cm 2 5 Ip 3 M max W cm 325 5 Control 1 Mode Color Color Control 2 Exam Type Any Any o g S Control 3 Optimization Depth PRF Low 3 3 cm Med amp v 5 1938 Z Control 4 Color Box Position Size Top Any Short a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the
39. casssseasenseneeess 34 Area and circumference measurements 35 Measurement accuracy 35 Sources of measurement errors ccsssscsssessssssssesssessseccsscsssecsseesssessnecssecssseesseceseeessees 36 Chapter 5 Troubleshooting and Maintenance Troubles Nooti oe M Software licensing ssscssssscsssscssssccssssccsssecssusccsssecssusecssseessesees MaiMt mamee e Cleaning and disinfecting the ultrasound system Cleaning and disinfecting transducers Cleaning and disinfecting the battery sss 43 Chapter 6 Safety Ergonomic safety Position the system Position yourself tte nete en pa treten Take breaks exercise and vary activities sss 53 Electrical safety classification ou sessssssessssssescsssssescsssssessssssecssssesessssseessssseeesss 53 Electrical ET a S 53 Equiprent safety sen eseitteitlitesetetiei ise RII prete r ERES cede beua EU 56 Battery safety Clinical safety Electromagnetic compatibility Manufacturer s declaration ALARA principle s 62 Applying ALARA sseessssescssssscsssscsseescsscssssseecnsecesnsssensecesnsecesseesusesenseeesuseeensesess 63 DUE CE Controls tome LT EC 63 Indirect COMEKOIS ett 64 Receiver controls sisisi eestis iisas i 64 Acoustic artifacts cvssccssnssssccessssecevsasssansescapsdesecctavaconnovestcchuss
40. d by SonoSite Using gels other than the one recommended by SonoSite can damage the transducer and void the warranty If you have questions about gel compatibility contact SonoSite or your local representative SonoSite recommends that you clean transducers after each use See Cleaning and disinfecting transducers on page 41 Acoustic coupling gel must be used during exams Although most gels provide suitable acoustic coupling some gels are incompatible with some transducer materials SonoSite recommends Aquasonic gel and provides a sample with the system For general use apply a liberal amount of gel between the transducer and the body For invasive or surgical use install a transducer sheath WARNING To prevent contamination the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature Do not apply the transducer sheath and gel until you are ready to perform the procedure To install a transducer sheath SonoSite recommends the use of market cleared transducer sheaths for intracavitary or surgical applications To lessen the risk of contamination install the sheath only when you are ready to perform the procedure 1 Place gel inside the sheath 2 Insert the transducer into the sheath 3 Pull the sheath over the transducer and cable until the sheath is fully extended 4 Secure the sheath using the bands supplied with the sheath 5 Check for and el
41. ds 1 Log in as Administrator 2 Under User List click Administrator 3 Do any of the following Change the administrator password Under User Information type the new password in the Password box and Confirm box See Choosing a secure password on page 17 Let users change their passwords Select the Password changes check box 4 Click Save User setup To add a new user 1 Log in as Administrator 2 Click New 3 Under User Information fill in the Name Password and Confirm boxes See Choosing a secure password on page 17 4 Optional In the User box type the user s initials to display them in the patient header and the User box in the patient information form Uu Optional Select the Administration Access check box to allow access to all administration privileges 6 Click Save To modify user information 1 Log in as Administrator 2 Under User List click the user 3 Under User Information make changes as desired 4 Click Save Any change to the user name replaces the previous name To delete a user 1 Log in as Administrator 2 Under User List click the user 3 Click Delete 4 Click Yes Chapter 2 System Setup 15 dnjas uiejs g To change a user password 1 Log in as Administrator 2 In the User List click the user 3 Type the new password in the Password box and Confirm box 4 Click Save Exporting or importing user accounts The export and import commands let you configure
42. e carotid arteries deep veins and arteries in the arms and legs superficial veins in the arms and legs great vessels in the abdomen and various small vessels feeding organs can be assessed for the presence or absence of pathology Chapter 2 System Setup The setup pages let you customize the system and set preferences Displaying the setup pages To display a setup page 1 In 2D imaging mode do one of the following Press Patient and then press Setup on the horizontal row of control keys Press Setup on the vertical row of control keys 2 Click the setup page under Setup Pages To return to imaging from a setup page press Done Restoring default settings To restore default settings for a setup page On the setup page press Reset To restore all default settings 1 Turn the system off 2 Connect the system to AC power See To operate the system using AC power on page 4 3 Simultaneously press the power key and the control key below it the upper left control key The system beeps several times Chapter 2 System Setup 13 dnjas waysks Administration setup On the Administration setup page you can configure the system to require users to log in and enter passwords Required login helps protect patient data You can also add and delete users change passwords import and export user accounts and view the event log Security settings 14 WARNING Health care providers who maintain or transmit he
43. e required SonoSite provides a USB device containing the software One USB device can upgrade multiple systems To use the ultrasound system 1 Turn the system on For power switch location see System controls on page 7 2 Attach a transducer 3 Press Patient and complete the patient information form 4 Press an imaging mode control key 2D or Color Preparing the system Compartments and connectors The back of the system has compartments for the battery and transducer as well as connectors for USB devices power cords cables and more The side has additional connectors Chapter 1 Getting Started peueis 6Bunjo5 Soy 5 boa ou onmo Figure 1 1 System Back Left and Side Right 1 Handle 2 Transducer 3 Connectors See the table Connectivity Symbols on Back and Side of System 4 Battery compartment Each connector on the back and side of the system has a symbol that describes its use Connectivity Symbols on Back and Side of System Symbol Definition Symbol Definition DC input GC S video out C Print control RJ S video in og USB DVI video out Ethernet C gt Composite video out oa 0 NN Pm Not currently supported Installing or removing the battery WARNING To avoid injury to the operator and to prevent damage to the ultrasound system inspect the battery for leaks
44. e update screen Caution After the grace period expires all system functions except licensing are unavailable until a valid license key is entered To obtain a license key for your software contact SonoSite Technical Support See SonoSite Technical Support on page viii You need to provide the following information See System Information setup on page 20 Software License Key Information System Software Transducer Software Name of institution installing the upgrade Name of institution installing the upgrade Serial number on bottom of system Transducer serial number ARM version Transducer part number REF or model number for example C60x PCBA serial number Transducer bundle version After you obtain a license key you must enter it into the system To enter a license key 1 Turn on the system The license update screen appears 2 Enter the license key in the Enter license number field 3 Select Done on screen If you entered a valid license key but the license update screen appears verify that you entered the license key correctly If the license update screen still appears contact SonoSite Technical Support See SonoSite Technical Support on page viii Maintenance Use the recommendations in this section when cleaning or disinfecting your ultrasound system transducer and accessories Use the cleaning recommendations in the peripheral manufacturer s instructions when cleaning or disinfecting
45. ective for these two uses CPD or Color images can be used as an adjunctive method not as a screening tool for the detection of structural anomalies of the fetal heart and as an adjunctive method not as a screening tool for the diagnosis of Intrauterine Growth Retardation IUGR Pediatric Imaging Applications This system transmits ultrasound energy into the pediatric patients using 2D SonoMB multi beam technology color Doppler Color and color power Doppler CPD to obtain ultrasound images The pediatric abdominal and pelvic anatomy pediatric hips and surrounding anatomical structures can be assessed for the presence or absence of pathology Superficial Imaging Applications This system transmits ultrasound energy into various parts of the body using 2D SonoMB multi beam technology color Doppler Color and color power Doppler CPD to obtain ultrasound images The breast thyroid testicle lymph nodes hernias musculoskeletal structures soft tissue structures and surrounding anatomical structures can be assessed for the presence or absence of pathology This system can be used to provide ultrasound guidance for biopsy and drainage procedures vascular line placement peripheral nerve blocks and spinal nerve blocks and taps Vascular Imaging Applications This system transmits ultrasound energy into the various parts of the body using 2D SonoMB color Doppler Color and color power Doppler CPD to obtain ultrasound images Th
46. em for a printer 1 Set up the printer hardware See instructions included with the printer or S Series stand 2 On the Connectivity setup page click the printer in the Printer list To configure the system for a DVD recorder or bar code scanner 1 On the Connectivity setup page do the following DVD recorder In the Video Mode list click the video standard NTSC or PAL In the Serial Port list click the peripheral 2 Click Yes to restart the system 3 Attach a serial cable RS 232 from the serial port on the back of the system to the peripheral To receive storage alerts On the Connectivity setup page select Internal Storage Capacity Alert The system displays a message if internal storage is near capacity when you end an exam Date and Time setup To set the date and time On the Date and Time setup page do the following n the Date box type the current date See Entering text on page 9 In the Time box type the current time in 24 hour format hours and minutes Display Information setup On the Display Information setup page you can specify which details appear on screen during imaging You can select check boxes in the following sections Patient Header Information from the patient information form See Patient information form on page 27 Mode Data Imaging information System Status Power battery printer and similar information Presets setup The Presets setup page has settin
47. ent data on measurements Area 5 Patient Header Includes current patient name patient ID number institution user and date time 6 System Status Information on system status for example exam type transducer AC connected battery charging and USB 7 Depth Marker Marks in 5 cm 1 cm and 5 cm increments depending on depth To specify style see Presets setup on page 19 8 Exam label Preset exam label from patient information form 9 Control keys Controls available in the current context See also Control keys on page 9 General interaction Touchpad In forms and the setup pages the touchpad is similar to a mouse on portable PCs Using the touchpad you move the pointer to an item and then click press the key below the touchpad to activate that item In other contexts the touchpad adjusts and moves items on screen calipers region of interest ROT box and more Control keys The control keys display forms adjust settings and perform actions such as freezing and zooming The functionality depends on context The current name appears on screen next to the key Control keys are usually pressed but in forms you can also click them The Page x x control key displays additional control keys A control key functions in one of the following ways Cycle Moves through a list of settings On Off Turns a feature on or off Action Performs an action such as saving a clip AN Save N Color a Figure 1 5 Con
48. er Login screen appears when you turn on the system See To require user login on page 14 To log in as user 1 Turn on the system 2 In the User Login screen type your name and password and click OK To log in as guest Guests can scan but can t access system setup and patient information 1 Turn on the system 2 In the User Login screen click Guest To change your password 1 Turn on the system 2 In the User Login screen click Password 3 Type your old and new passwords confirm the new password and then click OK Choosing a secure password To ensure security choose a password that contains uppercase characters A Z lowercase characters a z and numbers 0 9 Passwords are case sensitive Chapter 2 System Setup 17 dnjas uiejs g Audio Battery setup On the Audio Battery setup page you can select options from the following lists Key click Click On or Off for keys to make a clicking sound when pressed Beep alert Click On or Off for the system to beep when saving warning starting or shutting down Sleep delay Click Off or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode Power delay Click Off or 15 or 30 minutes to specify the period of inactivity before the system automatically turns off Connectivity setup On the Connectivity setup page you select options for using devices and for alerts when internal storage is full To configure the syst
49. er fetal tissue and 7 C 12 6 F for second trimester fetal bone Estimated maximum temperature elevations given here are for a fixed path tissue model and are for devices having Ispra values greater than 500 mW cm The temperature elevations for fetal bone and tissue were computed based on calculation procedures given in Sections 4 3 2 1 4 3 2 6 in Bioeffects and Safety of Diagnostic Ultrasound AIUM 1993 Acoustic output tables Table 8 through Table 13 indicate the acoustic output for the system and transducer combinations with a thermal index or mechanical index equal to or greater than one These tables are organized by transducer model and imaging mode For a definition of terms used in the tables see Terms used in the acoustic output tables on page 78 Chapter 6 Safety 71 Ayayes Table 8 Transducer Model C11x 8 5 Operating Mode CPD Color TIS TIB Index Label M Non scan TIC Scan Non scan Aaprt lt 1 Aaprt gt 1 Global Maximum Index Value a a 1 2 Pr3 MPa Wo mW 40 50 Y min of W 5 z4 la 3 z4 mW 3 5 Z cm lt a z cm iiu oof Sg 5 8 i deqlZsp cm i R MH2 4 4 38 Dim of Aaprt X cm E 0 36 Y cm 0 5 PD use 5 PRF H2 E D Pll max MPa OS deq Pllmax cm E Focal Length FL cm 1 56 E FLy cm ES 2 5 Ip 3 M max W
50. es 2596 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 7096 Ur 30 dip in Ur for 25 cycles gt 5 Ur gt 95 dip in Ur for 5s Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SonoSite ultrasound system requires continued operation during power mains interruptions it is recommended that the SonoSite ultrasound system be powered from an uninterruptible power supply or a battery Table 2 Manufacturer s Declaration Electromagnetic Immunity Continued Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Power Frequency Magnetic Field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 A m 3 Vrms 150 kHz to 80 MHz 3 Vim 80 MHz to 2 5 GHz 3 A m 3 Vrms 3 V m If image distortion occurs it may be necessary to position the SonoSite ultrasound system further from sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the Intended installation location to
51. esscssescsssescssescssecsensesessesesnsesesneeeenseeess 87 Airborne equipment standards c sssesssesssssssccssscsssssscssssesssecsssesssecseessscssnscenseesees 88 FHIPAA e schantito Me M I 88 Glossary MI e M 89 Abbreviations ou sesssssescsssccsseccssssecssecessecsnsccesseessnscsessssesnscssssecessscssuseessseesenseeesnessenses 91 vi Introduction This S Series Ultrasound System User Guide provides information on preparing and using the S Series ultrasound system and on cleaning and disinfecting the system and transducers It also provides system specifications and safety and acoustic output information The user guide is for a reader familiar with ultrasound techniques It does not provide training in sonography or clinical practices Before using the system you must have ultrasound training See the applicable SonoSite accessory user guide for information on using accessories and peripherals See the manufacturer s instructions for specific information about peripherals Conventions The user guide follows these conventions A WARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products Numbered steps must be performed in a specific order Bulleted lists present information in list format but do not imply a sequence Symbols and terms used on the system and transducer
52. exhibits erratic or inconsistent behavior Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use information concerning MI and TI Chapter 6 Safety 57 Ayayes WARNING SonoSite does not currently recommend a specific brand of acoustic standoff If an acoustic standoff is used it must have a minimum attentuation of 3dB cm MHz Some SonoSite transducers are approved for intraoperative applications if a market cleared sheath is used Electromagnetic compatibility The ultrasound system has been tested and found to comply with the electromagnetic compatibility EMC limits for medical devices to IEC 60601 1 2 2001 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation Caution 58 Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions It is possible that high levels of radiated or conducted radio frequency electromagnetic interference EMI from portable and mobile RF communications equipment or other
53. for you Electrical safety classification Class equipment Ultrasound system powered from power supply or part of the S Series stand Internally powered equipment Ultrasound system not connected to the power supply battery only Type BF applied parts Ultrasound transducers IPX 7 watertight equipment Ultrasound transducers Non AP APG Ultrasound system power supply S Series stand and peripherals Equipment is not suitable for use in the presence of flammable anaesthetics Electrical safety This system meets EN60601 1 Class I internally powered equipment requirements and Type BF isolated patient applied parts safety requirements This system complies with the applicable medical equipment requirements published in the Canadian Standards Association CSA European Norm Harmonized Standards and Underwriters Laboratories UL safety standards See Chapter 7 Specifications Chapter 6 Safety 53 Ayayes 54 For maximum safety observe the following warnings and cautions WARNING To avoid discomfort or minor risk of patient injury keep hot surfaces away from the patient Under certain circumstances the transducer connector and back of the display enclosure can reach temperatures that exceed EN60601 1 limits for patient contact therefore only the operator shall handle the system This does not include the transducer face To avoid discomfort or minor risk of operator injury when handling the transducer connect
54. forms one form of energy into another form of energy Ultrasound transducers contain piezoelectric elements which when excited electrically emit acoustic energy When the acoustic energy is transmitted into the body it travels until it encounters an interface or change in tissue properties At the interface an echo is formed that returns to the transducer where this acoustic energy is transformed into electrical energy processed and displayed as anatomical information Abbreviations Abbreviations in User Interface Abbreviation Definition Abd Abdomen Bre Breast CPD Color Power Doppler Crd Cardiac MB SonoMB MI Mechanical Index Msk Musculoskeletal Nrv Nerve NTSC National Television Standards Committee OB Obstetrical S SonoHD imaging technology SmP Small Parts THI Tissue Harmonic Imaging TI Thermal Index Vas Vascular Ven Venous Glossary 91 Auesso 5 92 Index Numerics 2D imaging 21 A abbreviations 91 abdominal intended uses 11 accessories list 85 acoustic measurement precision 79 acoustic output measurement 69 tables 71 terms in tables 78 acquisition error 36 add new user 15 Administrator 14 airborne equipment standards 88 ALARA principle 62 63 89 alphanumeric keys 7 audio 3 18 battery charge 3 clean 43 install or remove 3 safety 56 setup 18 specifications 87 biological safety 57 Biopsy 24 brightness 21 C cables connect power 4 calipers 33 cardiac intended
55. gs for general preferences You can select from the following lists Depth Markers Type 1 displays unnumbered markers with the maximum depth number in the lower right screen Type 2 displays markers with numbers Thermal Index You can select TIS TIB or TIC The default setting is based on exam type OB is TIB TCD is TIC and all others are TIS Clip Length Clip length in seconds Language The system language Changing the language requires restarting the system Display Brightness High displays brighter key names and icons and is suitable for a bright environment such as daylight Low displays dimmer key names and icons and is suitable for a dark environment Auto save Pat Form Automatically saves the patient information form as an image in the patient s file Chapter 2 System Setup 19 dnjas uiejs g System Information setup The System Information setup page displays system hardware and software versions and license information See also To enter a license key on page 38 USB Devices setup 20 On the USB Devices setup page you can view information about connected USB devices including space availability You can also specify a file format for images you export to a USB storage device To specify a file format for exported images The image format you specify affects only still images Clips export in H 264 video saved as MP4 files To view them SonoSite recommends QuickTime 7 0 or later 1 On the
56. he system before cleaning the system To avoid the risk of electrical shock do not use any transducer that has been immersed beyond the specified cleaning or disinfection level See Chapter 5 Troubleshooting and Maintenance To avoid the risk of electrical shock and fire hazard inspect the power supply AC power cord and plug on a regular basis Ensure they are not damaged To avoid the risk of electrical shock and fire hazard the power cord set that connects the power supply of the ultrasound system or S Series stand to mains power must only be used with the power supply or S Series stand and cannot be used to connect other devices to mains power WARNING Caution To avoid the risk of electrical shock use only accessories and peripherals recommended by SonoSite including the power supply Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommend by SonoSite To avoid the risk of electrical shock inspect cables and power cords used within the system on a regular basis for damage To avoid the risk of electrical shock to the patient subject do not touch the system battery contacts while simultaneously touching a patient subject To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high v
57. hen either the TI or MI is greater than or equal to a value of 1 0 thus requiring display Table 5 Cases Where Either a Thermal or Mechanical Index is gt 1 0 Transducer Model Index 2D bid C11x 8 5 MI No No TIC TIB or TIS No Yes C60x 5 2 MI Yes No TIC TIB or TIS No No HFL38x 13 6 MI No Yes TIC TIB or TIS No Yes ICTx 8 5 MI No No TIC TIB or TIS No No L25x 13 6 MI No No TIC TIB or TIS No No L38x 10 5 MI No Yes TIC TIB or TIS No Yes P21x 5 1 MI Yes Yes TIC TIB or TIS Yes Yes Even when MI is less than 1 0 the system provides a continuous real time display of MI whenever a transducer is operated in a 2D imaging mode The index is displayed in increments of 0 1 The system meets the output display standard for TI A continuous real time display of TI is provided for the operator whenever a transducer is operated in a CPD or Color imaging mode The index is displayed in increments of 0 1 The thermal index consists of three user selectable indices and only one of these is displayed at any one time In order to display properly and meet the ALARA principle the user selects an appropriate TI based on the specific exam being performed SonoSite provides the AIUM Medical Ultrasound Safety reference which contains guidance on how to determine which TI is appropriate see second reference listed in Related guidance documents on page 67 Mechanical and thermal indices output display accuracy The accuracy result for the mech
58. iac Nrv Nerve OB Obstetrical SmP Small Parts Sup Superficial Vas Vascular Ven Venous 2 The optimization settings for 2D are Res Gen and Pen Patient information form The patient information form lets you enter patient identification exam and clinical information for the patient exam When you create a new patient information form all images and other data you save during the exam are linked to that patient See Saving images and clips on page 28 To create a new patient information form 1 In 2D press Patient 2 Press amp New 3 Fill in the form fields See Patient information form fields on page 28 and Entering text on page 9 4 Press Done To edit a patient information form You can edit patient information during the exam However if you change the patient name or ID after saving an image a new patient information form is created 1 In 2D press Patient 2 If you need to change the patient name or ID save any data you want to keep 3 Make changes as desired 4 Press one of the following Cancel to undo changes and return to imaging Done to save changes and return to imaging To end the exam 1 Make sure that you have saved images and other data you want to keep See Images and clips on page 28 2 In 2D press Patient 3 Doone of the following Press End Exam e Press New to begin a new patient information form See To create a new patient information form
59. ible Face forward Avoid twisting your head or body Move your entire body front to back and position your scanning arm next to or slightly in front of you Stand for difficult exams to minimize reaching Promote comfortable shoulder and arm postures Keep your elbow close to your side Relax your shoulders in a level position Support your arm using a support cushion or pillow or rest it on the bed Minimize neck bending and twisting Position the ultrasound system directly in front of you Promote comfortable hand wrist and finger postures Hold the transducer lightly in your fingers Minimize the pressure applied on the patient Keep your wrist in a straight position Take breaks exercise and vary activities Minimizing scanning time and taking breaks can effectively allow your body to recover from physical activity and help you avoid MSDs Some ultrasound tasks may require longer or more frequent breaks One way of taking a break is to stop and relax However simply changing tasks can help some muscle groups relax while others remain or become active Work efficiently by using the software and hardware features correctly Keep moving Avoid sustaining the same posture by varying your head neck body arm and leg positions Targeted exercises can strengthen muscle groups which may help you avoid MSDs Contact a qualified health professional to determine stretches and exercises that are right
60. iminate bubbles between the face of the transducer and the sheath Bubbles between the face of the transducer and the sheath may affect the ultrasound image 6 Inspect the sheath to ensure that there are no holes or tears Intended uses The intended uses for each exam type are as follows For the intended transducer for each exam type see Imaging modes and exams available by transducer on page 24 Abdominal Imaging Applications This system transmits ultrasound energy into the abdomen of patients using 2D SonoMB technology color Doppler Color color power Doppler CPD and Tissue Harmonic Imaging THI to obtain ultrasound images The liver kidneys pancreas spleen gallbladder bile ducts transplanted organs abdominal vessels and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally Cardiac Imaging Applications This system transmits ultrasound energy into the thorax of patients using 2D SonoMB technology color Doppler Color and Tissue Harmonic Imaging THD to obtain ultrasound images The heart cardiac valves great vessels surrounding anatomical structures overall cardiac performance and heart size can be assessed for the presence or absence of pathology Gynecology and Infertility Imaging Applications This system transmits ultrasound energy in the pelvis and lower abdomen using 2D SonoMB technology color power Doppler CPD and color Doppler Color to ob
61. imum for example Zsp Zp 3 in centimeters Table 14 Acoustic Output Terms and Definitions Continued Term Definition deq z Equivalent beam diameter as a function of axial distance z and is equal to A 4 n Wo IrA z where lz z is the temporal average intensity as a function of z in centimeters fc Center frequency in MHz Dim of Aaprt Active aperture dimensions for the azimuthal x and elevational y planes in centimeters PD Pulse duration microseconds associated with the transmit pattern giving rise to the reported value of MI PRF Pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI in Hertz P Pll max Peak rarefactional pressure at the point where the free field spatial peak pulse intensity integral is a maximum in Megapascals deq Pllmax Equivalent beam diameter at the point where the free field spatial peak pulse intensity integral is a maximum in centimeters FL Focal length or azimuthal x and elevational y lengths if different measured in centimeters Acoustic measurement precision and uncertainty All table entries have been obtained at the same operating conditions that give rise to the maximum index value in the first column of the table Measurement precision and uncertainty for power pressure intensity and other quantities that are used to derive the values in the acoustic output table are shown in the table below In accordance with
62. line 2 Using the touchpad position the first caliper and then click The other caliper becomes active 3 Using the touchpad position the other caliper If you move the calipers close together they shrink and the dotted line disappears To save the image with the measurements displayed see To save an image on page 28 Area and circumference measurements Area and circumference measurements use an ellipse with calipers You can measure the following Area in cm Circumference in cm To measure area or circumference 1 On a frozen image press Calipers 2 Press Ellipse Note If you exceed the allowed number of measurements Ellipse is not available 3 Use the touchpad to adjust the size and position of the ellipse Clicking toggles between position and size To save the image with the measurements displayed see To save an image on page 28 Measurement accuracy The measurements provided by the system do not define a specific physiological or anatomical parameter Rather the measurements are of a physical property such as distance for evaluation by the clinician The accuracy values require that you can place the calipers over one pixel The values do not include acoustic anomalies of the body The 2D linear distance measurement results are displayed in centimeters with one place past the decimal point if the measurement is ten or greater two places past the decimal point if the measurement is less than ten The linear
63. lossary 89 Aiessoj5 90 skinline SonoHD imaging technology SonoMB technology thermal index TI TIB bone thermal index TIC cranial bone thermal index TIS soft tissue thermal index Tissue Harmonic Imaging transducer A depth on the display that corresponds to the skin transducer interface A subset of the 2D imaging mode in which the 2D image is enhanced by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image A subset of the 2D imaging mode in which the 2D image is enhanced by looking at a target from three angles and then merging or averaging the scanned data together to improve overall image quality and in parallel reducing noise and artifacts The ratio of total acoustic power to the acoustic power required to raise tissue temperature by 1 C under defined assumptions See Chapter 6 Safety for a more complete description of TI A thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone A thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body A thermal index related to soft tissues Transmits at one frequency and receives at a higher harmonic frequency to reduce noise and clutter and improve resolution A device that trans
64. m surfaces Doing so may cause solution to leak into the system damaging the system and voiding the warranty Do not use strong solvents such as thinner or benzene or abrasive cleansers since these will damage the exterior surfaces Use only recommended cleaners or disinfectants on system surfaces Immersion type disinfectants are not approved for use on system surfaces When you clean the system ensure that the solution does not get inside the system controls or the battery compartment Do not scratch the LCD screen To clean the LCD screen Dampen a clean non abrasive cotton cloth with an ethanolic based liquid cleaner and wipe the screen clean Apply the cleaner to the cloth rather than the surface of the screen To clean and disinfect system surfaces 1 Turn off the system 2 Disconnect the system from the power supply or remove it from the stand 3 Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface 40 4 Mix the disinfectant solution compatible with the system following disinfectant label instructions for solution strengths and disinfectant contact duration 5 Wipe surfaces with the disinfectant solution 6 Air dry or towel dry with a clean cloth Cleaning and disinfecting transducers To disinfect the transducer and its cable use the immer
65. n Standards Association The C and US indicators next to this mark GP signify that the product has been evaluated to the applicable CSA and ANSI UL one ua Standards for use in Canada and the US respectively 80 Table 16 Labeling Symbols Continued Symbol Definition REF Catalog number Collect separately from other household waste see European Commission X Directive 93 86 EEC Refer to local regulations for disposal STERILE EO Contents sterilized using ethylene oxide process Ge Corrugated recycle Corrugated Recycles JESI DFEI OO 00 DE 9 e 8r Dangerous voltage Date of manufacture Direct Current DC Do not get wet Do not stack over 2 high Do not stack over 5 high Do not stack over 10 high Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices Chapter 6 Safety 81 Ayayes 82 Table 16 Labeling Symbols Continued Symbol Definition a O EL STERILE R D Pe IPX7 IPX8 Fragile Gel sterilized by radiation Hot Indoor use only Device emits a static DC magnetic field Non ionizing radiation Paper recycle Serial number type of control number Storage temperature conditions Submersible Protected against the effects of temporary immersion Water Tight Equipment Protected against the effects of extended immersion
66. nd Equipment NEMA UDe3 2004 In Situ derated and water value intensities All intensity parameters are measured in water Since water does not absorb acoustic energy these water measurements represent a worst case value Biological tissue does absorb acoustic energy The true value of the intensity at any point depends on the amount type of tissue and the frequency of the ultrasound passing through the tissue The intensity value in the tissue In Situ has been estimated by using the following formula In Situ Water e0249 where In Situ In Situ intensity value Water Water intensity value e 2 7183 a attenuation factor dB cm MHz Attenuation factor a for various tissue types are given below brain 0 53 heart 0 66 kidney 0 79 liver 0 43 muscle 0 55 1 skinline to measurement depth in cm f center frequency of the transducer system mode combination in MHz Chapter 6 Safety 69 Ayayes Since the ultrasonic path during the exam is likely to pass through varying lengths and types of tissue it is difficult to estimate the true In Situ intensity An attenuation factor of 0 3 is used for general reporting purposes therefore the In Situ value commonly reported uses the formula In Situ derated Water e 00695 Since this value is not the true In Situ intensity the term derated is used to qualify it The maximum derated and the maximum water values do not always occur at the same opera
67. ness Press Bright and then turn the ASA left hand knob Settings range from 1 to 10 You can also adjust the brightness of only the key names and icons See Presets setup on page 19 The display brightness affects battery life To conserve battery life adjust brightness to a lower setting Chapter 3 Imaging 21 2D settings Continued Control key Icon Description Optimize Orientation SonoMB MB Page x x gt G Settings are as follows Res provides the best possible resolution Gen provides a balance between resolution and penetration Pen provides the best possible penetration Some of the parameters optimized to provide the best image include focal zones aperture size frequency center and bandwidth and waveform They cannot be adjusted by the user Select from four image orientations U R Up Right U L Up Left D L Down Left D R Down Right MB On and MB Off turn SonoMB technology on and off When SonoMB is on MB appears in the upper left hand screen SonoMB depends on transducer and exam type Indicates which page of options is displayed Press to display the next page CPD and color Doppler imaging 22 Color power Doppler CPD and color Doppler Color are optional features CPD is used to visualize the presence of detectable blood flow Color is used to visualize the presence velocity and direction of blood flow in a wide range of flow states To di
68. nsducer 25 import user accounts 16 in situ definition 89 infertility intended uses 11 Index intended uses 11 intensity derated 69 in situ 69 water value 69 interventional intended uses 11 K keyboard on line 9 keys 7 knobs 7 L labeling symbols 80 language 19 LCD screen clean 40 output 67 license key 38 login Administrator 14 user 14 M maintenance 39 measurements accuracy 33 35 area 2D 35 circumference 2D 35 delete 34 distance 34 edit 34 errors 36 mechanical index MI 67 89 mode data 8 19 needle guide 24 NTSC definition 89 option 18 O OB intended uses 12 optimize 22 orientation marker 8 option 22 output display 67 P PAL definition 89 option 18 password 15 16 17 patient header 8 19 patient information form 27 patient list 28 PC 18 pediatric intended uses 12 peripherals 86 power delay 18 power key 7 precision acoustic measurement 79 preferences 19 presets 19 pressure limits 86 print 30 print control 3 printer problem 37 setup 18 probe See transducer R recording problem 37 S safety battery 56 clinical 57 electrical 53 electromagnetic compatibility 58 equipment 56 save 28 scanhead See transducer screen layout 8 security 14 serial port 18 setup pages 13 shipping specifications 86 skin line definition 90 sleep delay 18 software license 38 SonoHD 90 SonoMB 22 90 specifications 85 standards airborne equipment 88 electromechanical 8
69. nsity at the maximum MI in units of W cm TIS Soft tissue thermal index is a thermal index related to soft tissues TIS scan is the soft tissue thermal index in an auto scanning mode TIS non scan is the soft tissue thermal index in the non autoscanning mode TIB Bone thermal index is a thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone TIB non scan is the bone thermal index in the non autoscanning mode TIC Cranial bone thermal index is the thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body Aaprt Area of the active aperture measured in cm Pr3 Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI Megapascals Wo Ultrasonic power except for TIS in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts W 3 z4 Derated ultrasonic power at axial distance z in units of milliwatts Ispta 3 Z1 Derated spatial peak temporal average intensity at axial distance z milliwatts per square centimeter Z Axial distance corresponding to the location of maximum min W 3 z lt 5 z x 1 cm where z gt zbp in centimeters Zbp 1 69 Aaprt in centimeters Zsp For MI the axial distance at which p 5 is measured For TIB the axial distance at which TIB is a global max
70. ntensity ISPTA of 720 mW cm for all imaging modes The mechanical index MI and thermal index TI may exceed values greater than 1 0 on some transducers in some imaging modes One may monitor the MI and TI values and adjust the controls to reduce these values See Guidelines for reducing MI and TI on page 64 Additionally one means for meeting the ALARA principle is to set the MI or TI values to a low index value and then modifying this level until a satisfactory image or Doppler mode is obtained For more information on MI and TI see BS EN 60601 2 37 2001 Annex HH Chapter 6 Safety 63 Ayayes Indirect controls The controls that indirectly affect output are controls affecting imaging mode freeze and depth The imaging mode determines the nature of the ultrasound beam Tissue attenuation is directly related to transducer frequency The higher the PRF pulse repetition frequency the more output pulses occur over a period of time Receiver controls The receiver controls are the gain controls Receiver controls do not affect output They should be used if possible to improve image quality before using controls that directly or indirectly affect output Acoustic artifacts An acoustic artifact is information present or absent in an image that does not properly indicate the structure or flow being imaged There are helpful artifacts that aid in diagnosis and those that hinder proper interpretation Examples of artifacts incl
71. o 1 05 ATM 1 05 ATM For storage longer than 30 days store at or below room temperature 86 Electrical Power Supply Input 100 240 VAC 50 60 Hz 2 0 A Max 100 VAC Power Supply Output 1 15 VDC 5 0 A Max Power Supply Output 2 12 VDC 2 3 A Max Battery The battery comprises six lithium ion cells plus electronics a temperature sensor and battery contacts Run time is up to two hours depending on imaging mode and display brightness Electromechanical safety standards EN 60601 1 1997 European Norm Medical Electrical Equipment Part 1 General Requirements for Safety EN 60601 1 1 2001 European Norm Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems EN 60601 2 37 2001 Amendment A1 2005 European Norm Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment CAN CSA C222 No 601 1 M90 Canadian Standards Association Medical Electrical Equipment Part 1 General Requirements for Safety including CSA 601 1 Supplement 1 1994 and CSA 601 1 Amendment 2 1998 CEI IEC 61157 1992 International Electrotechnical Commission Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment UL 60601 1 1st Edition Underwriters Laboratories Medical Electrical Equipment Part 1 General Requirements for Safety EMC standards classification
72. of Ultrasound in Medicine AIUM 1994 A copy is included with each system Chapter 6 Safety 67 Ayayes Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD2 2004 Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment American Institute of Ultrasound in Medicine 1993 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment NEMA UD3 2004 Guidance on the interpretation of TI and MI to be used to inform the operator Annex HH BS EN 60601 2 37 reprinted at P05699 Transducer surface temperature rise 68 Table 6 and Table 7 list the measured surface temperature rise from ambient of transducers used on the ultrasound system The temperatures were measured in accordance with EN 60601 2 37 section 42 where controls and settings were positioned to give maximum temperatures Test 1 The transducer surface temperature test on tissue mimicking material TMM is based on the following standard 42 3 a 1 Test Method B IEC 60601 2 37 Amendment 1 The limit is a 10 C rise from ambient as measured on the TMM Test 2 The transducer surface temperature test in air is based on the following standard 42 3 a 2 IEC 60601 2 37 Amendment 1 The limit is a 27 C rise from ambient Test 3 The transducer surface temperature test on TMM is based on the following standard 42 3 a 1 Test Method B IEC 60601 2 37
73. oltage defibrillation pulse To avoid possible electrical shock or electromagnetic interference verify proper operation and compliance with relevant safety standards for all equipment before clinical use Connecting additional equipment to the ultrasound system constitutes configuring a medical system SonoSite recommends verifying that the system all combinations of equipment and accessories connected to the ultrasound system comply with JACHO installation requirements and or safety standards such as AAMI ES1 NFPA 99 OR IEC Standard 60601 1 1 and electromagnetic compatibility standard IEC 60601 1 2 Electromagnetic compatibility and are certified according to IEC Standard 60950 Information Technology Equipment ITE Do not use the system if an error message appears on the image display note the error code call SonoSite or your local representative turn off the system by pressing and holding the power key until the system powers down To avoid increasing the system and transducer connector temperature do not block the airflow to the ventilation holes on the back of the system Chapter 6 Safety 55 Ayayes Equipment safety To protect your ultrasound system transducer and accessories follow these precautions Caution Excessive bending or twisting of cables can cause a failure or intermittent operation Improper cleaning or disinfecting of any part of the system can cause permanent damage For cleaning and disinfecting
74. on page 27 Chapter 3 Imaging 27 Patient information form fields Field Description Last Patient name First ID Patient identification number Exam Exam type Exam label Exam specific label that appears in the lower right screen User User initials up to 3 characters Appears in the patient list and image header Institution Institution name Appears in the image header Images and clips Saving images and clips When you save an image or clip it saves to internal storage The system beeps afterward if Beep Alert is on and the percentage icon flashes See Audio Battery setup on page 18 The percentage icon shows the percentage of space used in internal storage To receive alerts when storage is near capacity see To receive storage alerts on page 18 To access saved images and clips open the patient list See Reviewing images and clips To save an image Press Save To save a clip Press Clip To specify clip length see Presets setup on page 19 Reviewing images and clips Caution If the internal storage icon does not appear in the system status area internal storage may be defective Contact SonoSite Technical Support See SonoSite Technical Support on page viii The patient list lets you organize saved images and clips from a central location 28 i Name Date Time O PATIENT1 2 ano4 00 59 O PATIENT2 n04 01 01 PATIENTS 345678 2009Jan04 01 04 SelectAll Clear
75. or the system should not be operated for more than 60 minutes continuously in a live scan mode as opposed to freeze or sleep modes To avoid the risk of electrical shock or injury do not open the system enclosures All internal adjustments and replacements except battery replacement must be made by a qualified technician To avoid the risk of injury do not operate the system in the presence of flammable gasses or anesthetics Explosion can result To avoid the risk of electrical shock use only properly grounded equipment Shock hazards exist if the power supply is not properly grounded Grounding reliability can only be achieved when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or the equivalent The grounding wire must not be removed or defeated To avoid the risk of electrical shock when using the system in an environment where the integrity of the protective earth conductor arrangement is in doubt operate the system on battery power only without using the power supply To avoid the risk of electrical shock do not connect the system s power supply or the S Stand s auxiliary mains outlet receptacles to an MPSO or extension cord To avoid the risk of electrical shock before using the transducer inspect the transducer face housing and cable Do not use the transducer if the transducer or cable is damaged To avoid the risk of electrical shock always disconnect the power supply from t
76. pear at the bottom of the screen The results update as you reposition the calipers by using the touchpad You can add calipers by pressing the Calipers key You can have multiple sets of calipers and can switch from one set to another repositioning them as needed Each set shows the measurement result The active calipers and measurement result are highlighted green A measurement is complete when you finish moving its calipers For an accurate measurement accurate placement of calipers is essential Chapter 4 Measurements 33 s usWaiNseayy To switch the active calipers Do one of the following To switch the active caliper within a set click To switch the active set press Switch To delete or edit a measurement With the measurement active highlighted do one of the following To delete press the Delete knob To edit use the touchpad to move the calipers To improve precision of caliper placement Do any of the following Adjust the display for maximum sharpness Use leading edges closest to the transducer or borders for starting and stopping points Maintain a consistent transducer orientation for each type of measurement Make sure that the area of interest fills as much of the screen as possible Minimize the depth or zoom Distance measurements 34 Distance is measured in cm To measure distance 1 On a frozen image press Calipers A pair of calipers appears connected by a dotted
77. prior to installing To avoid data loss and to conduct a safe system shutdown always keep a battery in the system To install the battery 1 Disconnect the power supply from the ultrasound system 2 Slide the two prongs at the bottom of the battery into the battery compartment on the back of the system 3 Lower the battery into the compartment 4 Push down on the locking lever at the top of the battery to secure the battery To remove the battery 1 Disconnect the power supply from the ultrasound system 2 Push down on the locking lever at the top of the battery and lift the battery up Using AC power and charging the battery The battery charges when the system is connected to the AC power supply A fully discharged battery recharges in less than five hours The system can run on AC power and charge the battery if AC power is connected to the system Chapter 1 Getting Started 3 panes buia The system can run on battery power for up to two hours depending on the imaging mode and the display brightness WARNING Caution The equipment shall be connected to a center tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system Verify that the hospital supply voltage corresponds to the power supply voltage range See Electrical on page 87 To operate the system using AC power 1 Connect the DC power cable from the power supply to the connector on the system
78. r immersing a transducer deeper or for a longer period of time than recommended can damage or discolor the transducer and void the transducer warranty Do not allow cleaning solution or disinfectant into the transducer connector Do not allow disinfectant to contact metal surfaces Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces Attempting to disinfect a transducer or transducer cable using a method other than the one included here can damage the transducer and void the warranty Chapter 5 Troubleshooting and Maintenance 41 Bunoouse qnoJj 42 To clean and disinfect a transducer wipe method 1 Disconnect the transducer from the system 2 Remove any transducer sheath 3 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface 4 Rinse with water or wipe with water dampened cloth then wipe with a dry cloth 5 Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration 6 Wipe surfaces with the disinfectant solution 7 Air dry or towel dry with a clean cloth 8 Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discontinue use of the t
79. ransducer and contact SonoSite or your local representative To clean and disinfect a transducer immersion method 1 Disconnect the transducer from the system 2 Remove any transducer sheath 3 Clean the surface using a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface 4 Rinse with water or a wipe with water dampened cloth and then wipe with a dry cloth 5 Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration 6 Immerse the transducer into the disinfection solution not more than 12 18 inches 31 46 cm from the point where the cable enters the connector Follow the instructions on the disinfectant label for the duration of the transducer immersion 7 Using the instructions on the disinfectant label rinse to the point of the previous immersion and then air dry or towel dry with a clean cloth 8 Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discontinue use of the transducer and contact SonoSite or your local representative Cleaning and disinfecting the battery Caution To avoid damaging the battery do not allow cleaning solution or disinfectant to come in contact with the battery terminals To clean and disinfect a battery wipe
80. ray NaCl Hypochlorite A A A U Dynacide PA FRA Liquid Peracetic Acid A A A U End Bac II USA Liquid Quat Ammonia A A A N Endozime AW Plus FRA Liquid Propanol A A A U Envirocide USA Liquid Isopropyl A U N U Enzol USA Cleaner Ethylene Glycol A A A U Expose USA Liquid Isopropyl A A A U Gigasept AF DEU Liquid Quat Ammonia A A A U Gigasept FF DEU Liquid Bersteinsaure N N N U Gluteraldehyde SDS USA Liquid Gluteraldehyde A U A U Hexanios FRA Liquid Polyhexanide Quat A A A U Ammonia Hi Tor Plus USA Liquid Chloride A A N U Hibiclens USA Cleaner Chlorhexidine A A A U e ueuajurey pue 6unoouse gnoJ s 193deu5 Lv Table 1 Disinfectants Compatible with System and Transducers Continued arean Soan Pe Aegre org Mae Go em Hydrogen Peroxide USA Liquid Hydrogen Peroxide A A A U Isopropanol Alcohol ALL Liquid Alcohol N N N U Kodan T cher DEU Liquid Propanol A A A U Kohrsolin ff DEU Liquid Gluteraldehyde A U A U Korsolex basic DEU Liquid Gluteraldehyde N N N U Korsolex extra DEU Liquid Ethanol Propanol A A A U Lem O Quat USA Liquid Alkyl Chloride N N N U LpHse USA Liquid O phenylphenol A A A U Lysol USA Spray Ethanol N N N N Lysol IC USA Liquid O phenylphenol A N A U Madacide 1 USA Liquid Isopropanol A A N A Matar USA Liquid O phenylphenol A U A U MetriCide 14 USA Liquid Gluteraldehyde A A A U MetriCide 28 USA Liquid Gluteraldehyde A A A U MetriZyme USA Cleaner Propylene Glycol A A A U Mikrobak forte DEU Liquid Ammonium Chloride A A A U Mikrozid
81. reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 74 Table 11 Transducer Model L38x 10 5 Operating Mode CPD Color TIS TIB Index Label M I Non scan TIC Scan Non scan Aaprt lt 1 Aaprt gt 1 Global Maximum Index Value 1 3 1 0 b Pr3 MPa 2 89 Wo mW 64 88 am E min of W 3 z4 la 3 24 mW 3 5 Z cm X vo iz cm E iik aif Som P 0 dagen cm lt fe MH2 4 91 4 91 Dim of Aaprt X cm 0 54 Y cm 0 4 PD usec 0 529 S PRF Hz 9547 E P Pllmax MPa 3 48 S deg Pllmax cm T Focal Length FL cm 1 5 z E FLy cm 2 5 Ip 3 Ml max W cm 439 3 Control 1 Mode Color CPD o 2 Control 2 Exam Type Any Bre s E S Control 3 PRF 331 2137 y 8 E Control 4 Optimization Depth Any 3 1 Med 3 1 O O Control 5 Color Box Position Size ABy Def Def Def a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Chapter 6 Safety 75 Ayayes Table 12 Transducer Model P21
82. sion method or the wipe method Immersible transducers can be disinfected only if the product labeling indicates they can be used with an immersion method See Table 1 Disinfectants Compatible with System and Transducers on page 44 WARNING Caution To avoid electrical shock before cleaning disconnect the transducer from the system To avoid injury always use protective eyewear and gloves when performing cleaning and disinfecting procedures To avoid infection ensure that the solution expiration date has not passed To avoid infection the level of disinfection required for a transducer is dictated by the type of tissue it contacts during use Ensure that the solution strength and duration of contact are appropriate for the equipment SonoSite tests products for compatibility of materials only SonoSite does not test for biological effectiveness For information see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology APIC and FDA Transducers must be cleaned after every use Cleaning transducers is necessary prior to effective disinfection Ensure that you follow the manufacturer s instructions when using disinfectants Do not use a surgeon s brush when cleaning transducers Even the use of soft brushes can damage a transducer Use a soft cloth Using a non recommended cleaning or disinfection solution incorrect solution strength o
83. splay the CPD or Color image 1 Press Color A ROI box appears in the center of the 2D image 2 Press CPD or Color on the left In Color imaging the Color indicator bar on the upper left hand screen displays velocity in cm s 3 Using the touchpad position the ROI box as needed A green outline shows the change Adjusting depth and gain To adjust depth You can adjust the depth in all imaging modes The vertical depth scale is marked in 0 5 cm 1 cm and 5 cm increments depending on the depth To change the style of depth markers see Presets setup on page 19 Turn the Depth knob Right increases the displayed depth Left decreases the displayed depth To adjust gain manually To adjust gain automatically in 2D see 2D settings on page 21 1 Press the left hand knob to select a setting el e Near 4 adjusts the gain applied to the near field of the image SM e Far 4 l adjusts the gain applied to the far field of the image Gain p adjusts the overall gain applied to the entire image In CPD or Color imaging the Overall setting affects the color gain applied to the region of interest ROI box The Near and Far settings affect only the 2D image Near and far correspond to the time gain compensation TGC controls on other ultrasound systems 2 Turn the knob Freezing viewing frames and zooming To freeze or unfreeze an image Press Freeze On a frozen image the cine icon and fr
84. ssscssssscccssesccssssecesssstececsnsecessnsecerssnseeessnueeessaneessenes 19 Presets setup sss we 19 System Information Setup csescsesecssssccsseecssseccsssecssseessseecsuseecsseecssseessseecssseessseesse 20 USB DeVices s tUp ssvecisscazscesccscztscsvsnssssusesscacsstasauscastaesibicsaissedensnastsessovecssatensesindazersbesins 20 Chapter 3 Imaging Imaging eee ro oet 21 2D imaging see 21 CPD and color Doppler imaging 22 Adjusting depth and gain 23 Freezing viewing frames and zooming 23 Turning guidelines on and off ssessssssscccssssecsessesceceseececsseeceesnsecessnseecessneesseneeeets 24 Imaging modes and exams available by transducer 24 Patient information form ssessssssssscssssesecccsseececsneeceessseeccessseecessueceesnseecesnneeseaneesss 27 Images and Clips notte terrre tastes leased e E EEEn EEan 28 Saving images and clips s sssssssssssssssssssssssssesseeeesssseesssnsssssssssssessseeseerrrersrreseses 28 Reviewing images and clips eese teen eennttnnttnnnnen 28 Printing exporting and deleting images and clips 30 Chapter 4 Measurements Working with calipers ssssssscsssecssscssecssecsecssscsssccsccsscssucceseccsscssssesseecssessnecsnseesseess 33 Distance measurements csscssssssessssssessssssscsecsscsecsecscsecsecsecsecsecssenecss
85. ssscvsaderbausdietdvecsectussbensonazschs 64 Guidelines for reducing MI and TI eene 64 O tp t display a aT M 66 Mechanical and thermal indices output display accuracy 67 Factors that contribute to display uncertainty sss 67 Related guidance documents ssssssscsssccseccssecsssesssecssecsssecsscessecssecesecesseesees 67 Transducer surface temperature rise sese eenntennnetnnn 68 Acoustic output measurement uu essescseecsecseecsecseecsccssecuccssecsecssccuecssecuecssecseenseesees 69 In Situ derated and water value intensities eee 69 Tissue models and equipment survey eee 70 Acoustic OUTPUT tables senserite asiett 71 Terms used in the acoustic output tables ses 78 Acoustic measurement precision and uncertainty 79 Labeling SYMADOIS c 80 Chapter 7 Specifications Supported transduUcers susesi iniiis iiris 85 VV AG iate Mano o S EET E LLL LS 85 Images and clips storage ssescssscsesccssecssecssccssscessccsscssnccencessccssccsasecsecssecsscecsecesseess 85 heeclr ec e M 85 XS diera 86 Temperature and humidity limits eene 86 Teide CS 87 Battery M 87 Electromechanical safety standards eerte 87 EMC standards classification sessssssscssescss
86. storage Internal storage The number of images and clips you can save depends on imaging mode and file format Accessories The following items are either included with or available for use on the ultrasound system Battery Biopsy Guide Needle Guide lower supply System AC power cord 10 ft 3 1 m e S Series stand Chapter 7 Specifications 85 suone yi edsg Peripherals Peripherals include medical grade conforming to EN60601 1 requirements and non medical grade commercial products Manufacturer s instructions accompany each peripheral Medical e Black and white printer grade Recommended sources for printer paper Contact Sony at 800 686 7669 or www sony com professional to order supplies or to find the local distributor DVD recorder Non medical Kensington Security Cable grade USB keyboard Temperature and humidity limits Note The temperature pressure and humidity limits apply only to the ultrasound system transducers and battery Table 1 Operating Limits System Battery Transducer 10 40 C 50 104 F 10 40 C 50 104 F 10 40 C 50 104 F 15 95 R H 15 95 R H 15 95 R H 700 to 1060hPa 0 7 to 700 to 1060hPa 0 7 to 1 05 ATM 1 05 ATM Table 2 Shipping and Storage Limits System without Battery Battery Transducer 35 65 C 31 149 F 20 60 C 4 140 F 35 65 C 31 149 F 15 95 R H 15 95 R H 15 95 R H 500 to 1060hPa 0 5to 500 to 1060hPa 0 5 t
87. strong or nearby radio frequency sources could result in performance disruption of the ultrasound system Evidence of disruption may include image degradation or distortion erratic readings equipment ceasing to operate or other incorrect functioning If this occurs survey the site to determine the source of disruption and take the following actions to eliminate the source s e Turn equipment in the vicinity off and on to isolate disruptive equipment e Relocate or re orient interfering equipment Increase distance between interfering equipment and your ultrasound system e Manage use of frequencies close to ultrasound system frequencies e Remove devices that are highly susceptible to EMI Lower power from internal sources within facility control such as paging systems Label devices susceptible to EMI e Educate clinical staff to recognize potential EMI related problems Eliminate or reduce EMI with technical solutions such as shielding e Restrict use of personal communicators cell phones computers in areas with devices susceptible to EMI Sharerelevant EMI information with others particularly when evaluating new equipment purchases which may generate EMI Purchase medical devices that comply with IEC 60601 1 2 EMC Standards Caution To avoid the risk of increased electromagnetic emissions or decreased immunity use Manufacturer s declaration only accessories and peripherals recommended by SonoSite
88. t press List To return to imaging press Done Printing exporting and deleting images and clips 30 WARNING To avoid damaging the USB storage device and losing patient data from it observe the following Do not remove the USB storage device or turn off the ultrasound system while the system is exporting Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system The connector could break To print an image 1 Verify that a printer is selected See To configure the system for a printer on page 18 2 Doone of the following n the patient list review the patient s images Press Print when the image appears Freeze the image and press Print To print multiple images 1 Verify that a printer is selected See To configure the system for a printer on page 18 2 Doone of the following Print all images for multiple patients Select one or more patients in the patient list Then press Print Print all images for one patient Highlight the patient in the patient list and press Print Each image appears briefly on screen while printing To export images and clips to a USB storage device A USB storage device is for temporary storage of images and clips Patient exams should be archived regularly To specify file format see USB Devices setup on page 20 A patient exam must be ended before you can export its images and clips See To end the exam
89. tain ultrasound images The uterus ovaries adnexa and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally Interventional Imaging Applications This system transmits ultrasound energy into the various parts of the body using 2D SonoMB technology color Doppler Color color power Doppler CPD and Tissue Harmonic Imaging THI to obtain ultrasound images that provide guidance during interventional procedures This system can be used to provide ultrasound guidance for biopsy and drainage procedures vascular line placement peripheral nerve blocks spinal nerve blocks and taps amniocentesis and other obstetrical procedures and provide assistance during abdominal breast and neurological surgery Chapter 1 Getting Started 11 panes buia Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of pregnant women using 2D SonoMB technology color Doppler Color and color power Doppler CPD to obtain ultrasound images The fetal anatomy amniotic fluid and surrounding anatomical structures can be assessed for the presence or absence of pathology transvaginally CPD and color Doppler Color imaging is intended for high risk pregnant women WARNING To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical Blood Sampling PUBS or in vitro Fertilization IVF The system has not been validated to be proven eff
90. terference in nearby electronic equipment RF emissions Class A The SonoSite ultrasound system is suitable for use in CISPR 11 all establishments other than domestic and those directly connected to the public low voltage power supply network which supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Chapter 6 Safety 59 Ayayes The system is intended for use in the electromagnetic environment specified below Table 2 Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Electrostatic Discharge ESD IEC 61000 4 2 Electrical fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 2 0KV 4 0KV 6 0KV contact 2 0KV 4 0KV 8 0KV air 2KV on the mains 1KV on signal lines 0 5KV 1 0KV 2 0KV on AC power lines to ground 0 5KV 1 0KV on AC power lines to lines gt 5 Ur 29596 dip in Ur for 0 5 cycle 4096 Ur 60 dip in U7 for 5 cycles 7096 Ur 3096 dip in U7 for 25 cycles gt 5 Ur 29596 dip in U7 for 5s 2 0KV 4 0KV 6 0KV contact 2 0KV 4 0KV 8 0KV air 2KV on the mains 1KV on signal lines 0 5KV 1 0KV 2 0KV on AC power lines to ground 0 5KV 1 0KV on AC power lines to lin
91. tery to an electrical power outlet WARNING Caution Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles If the battery leaks or emits an odor remove it from all possible flammable sources To avoid the battery bursting igniting or emitting fumes from the battery and causing equipment damage observe the following precautions Do not immerse the battery in water or allow it to get wet Do not put the battery into a microwave oven or pressurized container If the battery emits an odor or heat is deformed or discolored or in any way appears abnormal during use recharging or storage immediately remove it and stop using it If you have any questions about the battery consult SonoSite or your local representative Store the battery between 20 C 4 F and 60 C 140 F Use only SonoSite batteries Do not use or charge the battery with non SonoSite equipment Only charge the battery with the system Clinical safety Observe the following precautions related to clinical safety WARNING Non medical commercial grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis To avoid the risk of a burn hazard do not use the transducer with high frequency surgical equipment Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection Do not use the system if it
92. timate the In Situ acoustic exposure The amount of underestimation depends upon each specific situation Fixed path tissue models in which soft tissue thickness is held constant sometimes are used to estimate In Situ acoustic exposures when the beam path is longer than 3 cm and consists largely of fluid When this model is used to estimate maximum exposure to the fetus during transabdominal scans a value of 1 dB cm MHz may be used during all trimesters Existing tissue models that are based on linear propagation may underestimate acoustic exposures when significant saturation due to non linear distortion of beams in water is present during the output measurement The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad range of values Asurvey of 1990 equipment models yielded MI values between 0 1 and 1 0 at their highest output settings Maximum MI values of approximately 2 0 are known to occur for currently available equipment Maximum MI values are similar for real time 2D and M Mode imaging Computed estimates of upper limits to temperature elevations during transabdominal scans were obtained in a survey of 1988 and 1990 pulsed Doppler equipment The vast majority of models yielded upper limits less than 1 and 4 C 1 8 and 7 2 F for exposures of first trimester fetal tissue and second trimester fetal bone respectively The largest values obtained were approximately 1 5 C 2 7 F for first trimest
93. ting conditions therefore the reported maximum water and derated values may not be related by the In Situ derated formula For example a multi zone array transducer that has maximum water value intensities in its deepest zone but also has the smallest derating factor in that zone The same transducer may have its largest derated intensity in one of its shallowest focal zones Tissue models and equipment survey 70 Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from measurements of acoustic output made in water Currently available models may be limited in their accuracy because of varying tissue paths during diagnostic ultrasound exposures and uncertainties in the acoustic properties of soft tissues No single tissue model is adequate for predicting exposures in all situations from measurements made in water and continued improvement and verification of these models is necessary for making exposure assessments for specific exam types A homogeneous tissue model with attenuation coefficient of 0 3 dB cm MHz throughout the beam path is commonly used when estimating exposure levels The model is conservative in that it overestimates the In Situ acoustic exposure when the path between the transducer and site of interest is composed entirely of soft tissue When the path contains significant amounts of fluid as in many first and second trimester pregnancies scanned transabdominally this model may underes
94. transducer 1 Pull the transducer latch up and rotate it clockwise 2 Pull the transducer connector away from the system Chapter 1 Getting Started panes buia Inserting and removing USB storage devices Images and clips are saved to internal storage and are organized in a sortable patient list You can archive the images and clips from the ultrasound system to a PC using a USB storage device Although the images and clips cannot be viewed from a USB storage device on the ultrasound system you can remove the device and view them on your PC You can also import and export user accounts and the event log using a USB storage device There are three USB ports on the system two on the back and one on the side For additional USB ports you can connect a USB hub into any USB port WARNING To avoid damaging the USB storage device and losing patient data from it observe the following Do not remove the USB storage device or turn off the ultrasound system while the system is exporting Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system The connector could break Caution If the USB icon does not appear in the system status area on screen the USB storage device may be defective or password protected Turn the system off and replace the device To insert a USB storage device Insert the USB storage device into a USB port on the system See Figure 1 1 on page 2
95. trol key names lower screen Color imaging shown Entering text In forms you can enter text in text fields using either the on screen keyboard or an external USB keyboard connected to a USB port on the system To enter text in text fields 1 Click a text field The on screen keyboard appears with the text field at the top 2 Click each character you want to enter If an external keyboard is connected you can enter characters by typing e The fi key displays and hides international characters The SYMBOLS key displays symbols and punctuation The CAPSLOCK key turns capital letters on and off The SHIFT key d turns capital letters on or off for the next letter entered Chapter 1 Getting Started 9 peueis 6Bunyo5 The DELETE key deletes the character right of the pointer 3 Optional Navigate among text fields Click Next to advance to the next field Click Prev to return to the previous field 4 To exit the keyboard click one of the following OKto save changes 2D to save changes and display 2D imaging Preparing transducers 10 WARNING Caution Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Some gels and sterilants can cause an allergic reaction on some individuals To avoid damage to the transducer use only gels recommende
96. ude Shadowing Through transmission Aliasing Reverberations Comet tails For more information on detecting and interpreting acoustic artifacts see the following reference Kremkau Frederick W Diagnostic Ultrasound Principles and Instruments 7th ed W B Saunders Company Oct 17 2005 Guidelines for reducing MI and TI 64 The following are general guidelines for reducing MI or TI If multiple parameters are given then the best results may be achieved by minimizing these parameters simultaneously In some modes changing these parameters will not affect MI or TI Changes to other parameters may also result in MI and TI reductions Please note the MI or IT read out on the right side of the LCD screen means to decrease or lower setting of parameter to reduce MI or TI means to raise or increase setting of parameter to reduce MI or TI Table 3 MI Transducer Depth C11x i C60x HFL38x ICTx L25x L38x gt gt gt gt gt gt P21x Table 4 TI TIS TIC TIB Color Power Doppler Settings Transducer Pond Belo t Bien PRF Depth Optimize C11x T C60x i T HFL38x T ICTx 4 4 i Exam Gyn L25x i T L38x P21x 4 i ji Chapter 6 Safety 65 Ayayes Output display 66 The system meets the AIUM output display standard for MI and TI see last reference listed in Related guidance documents below Table 5 indicates for each transducer and operating mode w
97. ue 6unoouse gnoJ s 193deu5 Sy Table 1 Disinfectants Compatible with System and Transducers Continued Oeon Srana Pe Ademgeden Coeg rian C em Aquatabs 5000 IRL Tablet Sodium N N N U Dichloroisocyanurate Anioxyde 1000 FRA Liquid Peracetic Acid N N N U Ascend USA Liquid Quat Ammonia A A A U Asepti HB USA Liquid Quat Ammonia A A A U Asepti Steryl USA Spray Ethanol A A A N Asepti Wipes USA Wipe Propanol Isopropyl A A A A Alcohol Bacillocid rasant DEU Liquid Glut Quat Ammonia A A A U Banicide USA Liquid Gluteraldehyde A U A U Bleach USA Liquid NaCl Hypochlorite A A A U Cavicide USA Liquid Isopropyl A A A U Caviwipes USA Wipes Isopropanol A A N U Chlor Clean GBR Liquid Sodium A N A U Dichloroisocyanurate Cidalkan Lingettes FRA Wipes Ethyl Alcohol A A U U Cidex USA Liquid Gluteraldehyde A A A A Cidex OPA USA Liquid Ortho phthaldehyde A A A U Cidex Plus USA Liquid Gluteraldehyde A A A A Cleanisept DEU Wipes Quat Ammonia A A A A Clorox Wipes USA Wipes Isopropanol A A A U Bunoouse qnoJ 9y Table 1 Disinfectants Compatible with System and Transducers Continued Cleaning Solutions of Origin PE Activelngredient Depar HFL38x ask Surfaces Control Ill USA Liquid Quat Ammonia A A N U Coverage Spray USA Spray Quat Ammonia A A N N DentaSept FRA Liquid Quat Ammonia N N N U Denatured Alcohol USA Liquid Ethanol N N N U DisCide Wipes USA Wipes Isopropyl Alcohol A A A U DisOPA JPN Liquid Ortho phthaldehyde A A A U Dispatch USA Sp
98. x 5 1 Operating Mode 2D TIS TIB Index Label M Non scan TIC Scan Non scan Aaprt lt 1 Aaprt gt 1 Global Maximum Index Value 1 3 1 1 b Pr3 MPa 1 83 Wo mW 122 87 E min of W 5 z4 la 3 z4 mW 3 5 Z cm lt a z cm BEES Sog 8 i deqlZsp cm lt fe MHz 1 84 1 88 zm Dim of Aaprt X cm 0 590 Y cm 1 3 PD usec 0 963 S PRF Hz 4421 E Pr Pll max MPa 2 574 Es deq Pllmax cm Focal Length FL cm 1 55 5 FL cm 5 5 lp 3 MI max W cm 209 0 Control 1 Exam Type Card Abd OB EE Control 2 Optimization iin Any BE Control 3 Depth non 47 Control 4 THI On On a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 76 Table 13 Transducer Model P21x 5 1 Operating Mode CPD Color TIS TIB Index Label M Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 1 3 b Pr3 MPa 2 19 Wo mW 136 9
99. xed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SonoSite ultrasound system is used exceeds the applicable RF compliance level above the SonoSite ultrasound system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SonoSite ultrasound system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ALARA principle 62 ALARA is the guiding principle for the use of diagnostic ultrasound Sonographers and other qualified ultrasound users using good judgment and insight determine the exposure that is as low as reasonably achievable There are no set rules to determine the correct exposure for every situation The qualified ultrasound user determines the most appropriate way to keep exposure low and bioeffects to a minimum while obtaining a diagnostic examination A thorough knowledge of the imaging modes transducer capability system setup and scanning technique is necessary The imaging mode determines the nature of the ultrasound beam A stationary beam results in a
100. your body However if you experience symptoms such as constant or recurring discomfort pain throbbing aching tingling numbness burning sensation or stiffness do not ignore these warning signs Promptly see a qualified health professional Symptoms such as these can be linked with musculoskeletal disorders MSDs MSDs can be painful and may result in potentially disabling injuries to the nerves muscles tendons or other parts of the body Examples of MSDs include carpal tunnel syndrome and tendonitis While researchers are not able to definitively answer many questions about MSDs there is a general agreement that certain factors are associated with their occurrence including preexisting medical and physical conditions overall health equipment and body position while doing work frequency of work duration of work and other physical activities that may facilitate the onset of MSDs This chapter provides guidelines that may help you work more comfortably and may reduce your risk of MSDs f a Magnavita N L Bevilacqua P Mirk A Fileni and N Castellino Work related Musculoskeletal Complaints in Sonologists Occupational Environmental Medicine 41 11 1999 981 988 b Craig M Sonography An Occupational Hazard Journal of Diagnostic Medical Sonography 3 1985 121 125 c Smith C S G W Wolf G Y Xie and M D Smith Musculoskeletal Pain in Cardiac Ultrasonographers Results of a Random Survey Journal of

S Series Ultrasound System User Guide

Contents

Download Pdf Manuals

Related Search

Related Contents