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NanoMaxx Ultrasound System User Guide

1. z g z Zbp cm g 5 Zsp cm S amp Z PIl 3max 5 1 e 2 deqlZsp cm fe MHz 2 86 Dim of Aaprt X cm Y cm PD usec 0 58 S PRF Hz 4827 E P Pll max MPa 3 22 S deq P Imax cm Focal Length FL cm e9 lt 5 FLy cm a a Ip 3 MI max W cm 226 0 iS Control 1 Exam Type Any z w Control 2 2D Optimization Res 2 Control 3 Depth 7 8 cm S 2 Control 4 THI On Q S Y Control 5 MB Multi Beam amp Off 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 59 Ayayes Table 8 Transducer Model C60n 5 2 Operating Mode M Mode TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 1 a a a amp b Pr3 MPa 1 81 min of W 3 Z ta 3 Z1 mW V T Z1 cm z g z Zbp cm E Zsp cm S amp Z PIl 3max 4 7 O 2 deq Zsp cm fe MHz 2 84 Dim of Aaprt X cm Y cm PD usec 0 58 S
2. Tl 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 Ipa 3 MImax Derated pulse average intensity 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 can in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts W 3 z1 Derated ultrasonic power at axial distance z4 in units of milliwatts Ispta 3 Z1 Derated spatial peak temporal average intensity at axial distance z4 milliwatts per square centimeter Z4 Axial distance corresponding to the location of
3. Battery 20 60 C 4 140 F 15 95 R H For storage longer than 30 days store at or below room temperature 500 to 1060hPa 0 5 to 1 05 ATM Chapter 8 Specifications 79 suonesiinads Electrical Power Supply Input 100 240 VAC 50 60 Hz 2 0 10A Power Supply Output 1 15 VDC 5 0 A Power Supply Output 2 12 VDC 2 3 A Combined output not exceeding 75W Battery The battery comprises six lithium ion cells plus electronics a temperature sensor and battery contacts Run time is at least 45 minutes depending on imaging mode and display brightness Electromechanical safety standards EN 60601 1 2003 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 2008 European Norm Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment CAN CSA C22 2 No 601 1 M90 2002 Canadian Standards Association Medical Electrical Equipment Part 1 General Requirements for Safety including CSA 601 1 Supplement 1 1994 and CSA 601 1 1B 90 2002 CEI IEC 61157 2007 International Electrotechnical Commission Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment 80 Electrical UL 60601 1 1
4. The Page x x control displays additional controls Knob The knob works in conjunction with some touchscreen controls and adjusts gain depth brightness annotations and more In forms you can use the knob instead of the touchscreen controls to navigate through most fields and lists as follows e Turn clockwise for the next field e Tum counter clockwise for the previous field e Press to select the highlighted field Entering text In forms and annotations you can enter text in text fields using the on screen keyboard To enter text using the on screen keyboard 1 Tap a text field The on screen keyboard appears with the text field at the top 2 Tap each character you want to enter G 4 turns capital letters on or off for the next letter entered e Aj displays and hides international characters e Symbols displays symbols and punctuation e Aa turns capital letters on and off e Delete deletes the character right of the pointer e lt and gt reposition the pointer within text entered You can also tap in the text 3 Optional In forms navigate among text fields 6 Preparing transducers e Tap Next to advance to the next field e Tap Prev to return to the previous field 4 Tap Done Preparing transducers WARNING 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
5. e Head BPD HC e Abdomen AC e Limbs FL HL e AFI Q Q Q Q 30 Calculations b Position the calipers See To position To delete a measurement result from the calipers on page 25 patient report c Tap Save 1 Inthe patient report tap the measurement result To measure fetal heart rate FHR The measurement result is highlighted green 1 Ona frozen M Mode trace tap Calcs z owe ap Delete 2 Tap FHR A vertical caliper appears 3 Position the vertical caliper at the peak of the heartbeat and then tap Select See To position calipers on page 25 A second vertical caliper appears 4 Position the vertical caliper at the peak of the next heartbeat 5 Tap Save Patient report The patient report contains calculation results and patient information for the exam You can display the patient report during or after the exam The value for a calculation appears only if you performed and saved the calculation Calculation values that are out of range are indicated by the number sign and are not included in derived calculations for example mean To display the patient report 1 Do either of the following e Tap Options and select Report e Tap Patient and then tap Report 2 To display additional pages tap the arrows lt gt To exit the patient report and return to imaging tap Done Chapter 4 Measurements and Calculations 31 s UsWaiNseayy 32 Calculations
6. 3 Turn the knob The number below the icon changes to reflect the frame displayed To zoom in on an image You can freeze or unfreeze the image or change the imaging mode at any time while zooming 1 Tap Q A ROI box appears 2 Drag the ROI box where desired 3 Tap Cy again The image in the ROI box is magnified by 100 4 Optional If the image is frozen drag to pan the image up down left and right To exit zoom tap Q again Turning guidelines on and off WARNING To avoid patient injury use only needle guides that are approved for the transducer and system Guidelines are for needle guidance and are an optional feature This feature depends on the transducer and exam type For more information see SonoSite Bracket and Needle Guide User Guide To turn guidelines on or off On a2D image tap fj Annotating images You can annotate live images as well as frozen images You cannot annotate a saved image You can place text a predefined label an arrow or a pictograph To set preferences see Annotations setup on page 12 To place text or a label 1 Tap Annotate and select Text or Label A green cursor appears 2 Drag the cursor where desired For text you can also tap Home to move the cursor to the home position See also To reset the home position on page 20 3 Do one of the following e For text tap Keyboard and type text See Entering text on page 6 e Fora l
7. 4 Tap Save Any change to the user name replaces the previous name To delete a user 1 Log in as Administrator 2 Under User List select the user 3 Tap Delete 4 Tap Yes to confirm deletion To change a user password 1 Log in as Administrator 2 Under User List select the user 3 Type the new password in the Password box and Confirm box 4 Tap Save Exporting or importing user accounts The export and import commands let you configure multiple systems and back up user account information To export user accounts 1 Insert a USB storage device 2 Login as Administrator 3 Tap Export A list of USB devices appears 4 Select the USB storage device and tap Export All user names and passwords are copied to the USB storage device Passwords are encrypted To import user accounts 1 Insert the USB storage device that contains the accounts Log in as Administrator Tap Import u F amp F U N Tap Restart 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 on a PC To display the Event log 1 Login as Administrator 2 Tap Log The Event log appears To return to the previous screen tap Back To export the Event log The Event log has the file name og txt Exporting the Event log
8. TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 1 2 2 4 Pr3 MPa 2 15 Wo mW 119 7 177 8 min of W 3 z1 lTa 3 z1 mW Z1 cm z 3 T Zp cm lt i P E z Zsp cm ane S amp Z PIl 3max 49 B iae cm Z fe MHz2 2 15 2 17 2 15 Dim of Aaprt X cm 0 85 1 97 Y cm 1 3 1 3 PD usec 0 85 S PRF H 1126 E D Pll max MPa 2 835 deq Pllmax cm 7 Focal Length FL cm 3 68 13 84 FLy cm 5 5 5 5 Ipa 3 Mlmax W cm 367 2 A Control 1 Mode CPD or CPD or Color Color Color Ss Control 2 Exam Type Abd OB Cardiac D E Control 3 2D Optimization Pen Pen Gen Control 4 Depth 4 7cm 7 5 cm 24cm Control 5 THI On Off Off 9 Control 6 Color Box Default Default Default 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 67 Ayayes Terms used in the acoustic output tables 68 Table 16 Acoustic Output Terms and Definitions Term Definition Ispra 3 Derated spatial peak temporal average intensity in units of milliwatts cm
9. Tap IMT and select a measurement Measurements already performed have a check mark e Lat F Lateral Far Wall e Lat N Lateral Near Wall e Post F Posterior Far Wall e Post N Posterior Near Wall e Ant F Anterior Far Wall e Ant N Anterior Near Wall The IMT tool appears Using the IMT tool controls position and adjust the tool as needed See IMT tool controls on page 28 If you want to save the measurement tap Save The measurement saves to the patient report and the image with the measurement displayed saves to internal storage Exit the measurement by tapping one of the following e Unfreeze to return to live imaging e Clear Calc to clear the measurement from the screen allowing additional measurements on the image Calculations IMT tool controls The IMT tool has the following controls Left Right Repositions the tool horizontally or Up Down vertically With Left Right turn the knob clockwise to move the tool right or counter clockwise to move the tool left With Up Down turn the knob clockwise to move the tool down or counter clockwise to move the tool up You can also drag the tool with your finger Tap Touch screen and then drag Press the knob to return to the previously displayed controls A Adjusts the lumen intima line or adventitia media line Do either or Lumen both of the following Turn the knob clockwise to move the line down or counter w T clockwi
10. 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 eliminate 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 system transmits ultrasound energy into various parts of the patient s body to obtain ultrasound images as follows For the intended transducer and imaging modes for each exam type see Imaging modes and exams available by transducer on page 24 Abdominal Imaging Applications You can assess the liver kidneys pancreas spleen gallbladder bile ducts transplanted organs abdominal vessels and surrounding anatomical structures for the presence or absence of pathology transabdominally Cardiac Imaging Applications You can assess the heart cardiac valves great vessels surrounding anatomical structures overall cardiac performance and heart size for the presence or absence of pathology Gynecology and Infertility Imaging Applications You can assess the uterus ovaries adnexa and surrounding anatomical structures for the presence or absence of pathology transabdominally Interventional Imaging Applications You can use the system to provide ultrasound guidance for b
11. Ayayes Acoustic measurement precision and uncertainty 70 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 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 17 Acoustic Measurement Precision and Uncertainty Quantity Precision of standard deviation Uncertainty 95 confidence Pr 1 9 11 2 Pr3 1 9 12 2 Wo 3 4 10 fc 0 1 4 7 PII 3 2 12 5 to 16 8 Pll 3 2 13 47 to 17 5 Labeling symbols The following symbols are used on the products packaging and containers Table 18 Labeling Symbols Symbol Definition NY O hur F4 i UO JI m T Lo STERILE EO Alternating Current AC Class 1 device indicating manufacturer s declaration of conformance with Annex VII of 93 42 EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features or to a Class Ila IIb or Ill device requiring verification or auditing by the Notified Body to applicable Annex es
12. 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 list to help troubleshoot the problem If the problem persists contact SonoSite Technical Support See SonoSite Technical Support on page vii System does not turn on Check all power connections Remove the DC input connector and battery wait 10 seconds reinstall the battery and then reinstall the DC input connector Ensure that the battery is charged System image quality is poor Adjust the screen to improve viewing angle Adjust the brightness Adjust the gain No CPD image Adjust the gain No Color image Adjust the gain or the scale Print does not work Select the printer on the Connectivity setup page See To configure the system for a printer on page 12 Check the printer connections Ensure that the printer is turned on and set up properly See the printer manufacturer s instructions if necessary Missing control Tap Page x x to display additional controls System does not recognize the transducer Disconnect and reconnect the transducer Make sure that the connectors are free of debris Verify that you are using a supported transducer A maintenance icon N appears System maintenance
13. 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 Measurement publications The following publications are used for each calculation result Terminology and measurements comply with AIUM published standards IMT references Howard G Sharrett AR Heiss G Evans GW Chambless LE Riley WA et al Carotid Artery Intima Medial Thickness Distribution in General Populations As Evaluated by B Mode Ultrasound ARIC Investigators Atherosclerosis Risk in Communities Stroke 1993 24 1297 1304 O Leary Daniel H MD and Polak Joseph F MD et al Use of Sonography to Evaluate Carotid Atherosclerosis in the Elderly The Chapter 7 References 75 saouaiajay Cardiovascular Health Study Stroke September 1991 22 1155 1163 Redberg Rita F MD and Vogel Robert A MD et al Task force 3 What is the Spectrum of Current and Emerging Techniques for the Noninvasive Measurement of Atherosclerosis Journal of the American College of Cardiology June 4 2003 41 11 1886 1898 OB references Amniotic Fluid Index AFI Jeng C J et al Amniotic Fluid Index Measurement with the Four Quadrant Technique During Pregnancy The Journal of Reproductive Medicine 35 7 July 1990 674 677 Average Ultrasound Age AUA The system provides an AUA derived from the
14. x pul error message 43 errors acquisition 75 algorithmic 75 measurement 75 estimated date of delivery EDD 76 estimated fetal weight EFW 76 Event log 11 exam end 21 type and transducer 24 type change 24 export Event log 11 images 23 predefined label groups 12 USB Devices setup 14 user accounts 10 export type 14 E focal zones optimize 17 freeze 19 G gestational age references 76 setup 13 grace period 33 guidance documents related 55 Guide 19 guidelines 19 gynecology intended uses 7 H heart rate 21 26 HIPAA standard 80 home position 20 humidity limits 79 l image quality poor 33 images delete 23 export to USB 23 review 22 save 21 86 Index imaging modes list of 79 transducer 24 import predefined label groups 12 user accounts 10 IMT calculations 27 in situ definition 81 include private tags 14 infertility intended uses 7 intended uses 7 intensity derated 56 in situ 56 water value 56 interventional intended uses 7 K keyboard on screen 6 knob 6 L labeling symbols 71 labels placing on images 19 license key 33 login Administrator 9 user 10 M maintenance 34 measurements accuracy 25 75 circumference 25 delete 27 distance 26 edit 27 errors 75 publications 75 terminology 75 mechanical index MI 54 81 M line 17 mode data 5 13 needle guide 19 NTSC definition 81 O OB calculations 29 intended uses 7 references 76 optimize 17 orientation ma
15. 3 Figure 1 System front top and back bottom Handle Knob Power switch Touchscreen Battery compartment USB ports on side Transducer compartment Kickstand oO ON WD a BW N Dock connector See the table Connectivity symbols on dock Chapter 1 Getting Started payieis 6unjayD Preparing the system Compartments and connectors The back of the system has a battery compartment a transducer compartment and a connector for the NanoMaxx dock The side has two USB ports See Figure 1 on page 1 Dock The dock has ports for the power supply printer cable and more It attaches to the back of the system See Figure 1 on page 1 Each port has a symbol that describes its use Connectivity symbols on dock Symbol Definition e DC input 4 Audio out B Print control C gt Composite video out lt 3 Composite video in To connect the dock WARNING To avoid electrical shock to the patient do not simultaneously touch the patient and the dock if it is disconnected from the system and connected to AC power Insert the dock into its connector on the back of the system See Figure 1 on page 1 The top of the dock has the SonoSite logo 2 Preparing the system Kickstand The kickstand lets you set the system upright on a flat surface You can extend the kickstand as needed for your optimal viewing angle Figure 2 Back of system with kickstand extende
16. Caution Verify that the hospital supply voltage corresponds to the power supply voltage range See Electrical on page 80 To operate the system using AC power 1 Connect the dock to the system 2 Connect the DC power cable from the power supply to its port on the dock See Figure 1 on page 1 3 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 screen 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 front top and back bottom on page 1 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 12 Tap the screen Connecting transducers WARNING To avoid injury to the patient do not place the connector on the patient Operate the ultrasound system in the V Universal Stand or on a convenient surface to allow air flow past the connector To avoid the risk of electrical shock do not touch the transducer connector which is in the transducer compartment on the system when the transducer is not connected See Figure 1 on page 1 Caution To avoid damaging the transducer connector do not allow f
17. 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 ina 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 9g on the system See Figure 1 on page 1 The USB storage device is ready when the USB icon appears To view information about the device see USB Devices setup on page 14 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 at least five seconds after the USB animation stops 2 Remove the USB storage device from the port Screen layout 1 2 3 4 5 DOE JOHN 123456789 Touch screen Left Right Patient 10 9 Figure 4 Screen layout 1 Text Text entered using on screen keyboard 2 Pictograph Indicates anatomy and transducer position You can select anatomy and screen location 3 Orientation marker Shows image orientation 4 Measurement 5 Mode data and system status Current imaging mode information such as Gen MB and system information such as exam type transducer and
18. Exam Type Abd Gyn S 5 Nrv OB 29 Control 3 2D Optimization Pen G Control 4 Depth 7 8 cm amp Control 5 THI On Control 6 Color Box Default 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 61 Ayayes Table 10 Transducer Model L38n 10 5 Operating Mode 2D TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 a b Pr3 MPa 3 23 Wo mW min of W 3 z hta 3 Z1 mW U rA Z cm z g 2 Zbp cm i E 5 Zsp cm g amp Z Pll zmax 0 9 2 deqlZsp cm fe MHz 5 07 Dim of Aaprt X cm Y cm PD usec 0 32 S PRF Hz 5221 z P Pll max MPa 3 78 amp deg Pllmax cm Focal Length FL cm ue oD lt lt 5 FLy cm lIpa 3 Mlmax W cm 602 0 ro Control 1 Exam Type Msk A Nrv SS Control 2 2D Optimization Pen o 5 g Control 3 Depth 4 7 cm S S Control 4 MB Multi Beam 2 Off O a Th
19. List To return to imaging tap Done Printing and deleting images 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 12 2 Do one of the following e Inthe patient list review the patient exam s images Tap Print when the image appears e Freeze the image and tap Print To print multiple images 1 Verify that a printer is selected See To configure the system for a printer on page 12 2 Do one of the following e Print all images for multiple patient exams Select one or more patient exams in the patient list Then tap Print e Print all images for one patient exam Highlight the patient exam in the patient list and tap Print Each image appears briefly on screen while printing To delete images 1 Select one or more patient exams in the patient list 2 Tap Delete to delete the selected exams A confirmation screen appears Exporting to a USB storage device A USB storage device is for temporary storage of images Patient exams should be archived regularly To specify file fo
20. and days and are calculated as follows GA LMPd System Date LMPd Last Menstrual Period Derived LMPd by Established Due Date Estab DD Results are displayed as month day year LMPd Estab DD Estab DD 280 days Gestational age tables Abdominal Circumference AC Hadlock F et al Estimating Fetal Age Computer Assisted Analysis of Multiple Fetal Growth Parameters Radiology 152 1984 497 501 Hansmamn M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1985 431 University of Tokyo Shinozuka N FJSUM et al Standard Values of Ultrasonographic Fetal Biometry Japanese Journal of Medical Ultrasonics 23 12 1996 885 WARNING The gestational age calculated by your SonoSite system does not match the age in the aforementioned reference at the 20 0 cm and 30 0 cm abdominal circumference AC measurements The implemented algorithm extrapolates the gestational age from the slope of the curve of all table measurements rather than decreasing the gestational age for a larger AC measurement indicated in the referenced table This results in the gestational age always increasing with an increase in AC Biparietal Diameter BPD Chitty L S and D G Altman New charts for ultrasound dating of pregnancy Ultrasound in Obstetrics and Gynecology 10 1997 174 179 Table 3 Hadlock F et al Estimating Fetal Age Computer Assist
21. battery charging To specify details see System Information setup on page 13 6 Patient header Includes current patient name patient ID number institution user date and time 7 Depth marker Marks in 5 cm 1 cm and 5 cm increments depending on depth To specify style see Presets setup on page 13 8 Controls available in the current context See Touchscreen on page 5 9 Ultrasound image 10 Measurement data General interaction Touchscreen The touchscreen has controls that change dynamically depending on context For example freezing an image displays the controls for zooming performing measurements and reviewing the cine buffer You can also reposition some elements for example the zoom box or calipers by dragging with your finger For best results try the following e Using the back of your fingernail instead of your fingertip e Pressing firmly e Dragging from next to the element instead of on it To select a control tap it with your finger A control functions in one of the following ways e Cycles through a list of settings Identified by a plus sign e Displays a list from which to select Identified by an arrow amp Tapping the control displays and collapses the list e Works in conjunction with the knob Identified by a double circle Chapter 1 Getting Started 5 pees bunya e Turns a feature on or off e Performs an action such as saving an image
22. control number Temperature limitation Atmospheric pressure limitation Humidity limitations Submersible Protected against the effects of temporary immersion Handle transducer with care Type BF patient applied part B body F floating applied part Underwriter s Laboratories labeling Pollution Control Logo Number in the center may vary 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 Chapter 6 Safety 73 Ayayes 74 Table 18 Labeling Symbols Continued Symbol Definition 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 WARNING Connect Only Connect Only Accessories and Peripherals Recommended by SonoSite Accessories and Peripherals Recommended by SonoSite Chapter 7 References 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 l
23. 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 lines gt 5 Ur gt 95 dip in U for 0 5 cycle 40 Uy 60 dip in U7 for 5 cycles 70 Uz 30 dip in U7 for 25 cycles gt 5 Ur gt 95 dip in U 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 ora 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 Sono
24. exams ceessescsecssecseessecsesseecseecsecscessesseesecseeceeensecseeseesees 21 Printing and deleting images csssscssecsescssecssecssecsseecssecsscssscceseesseesecerseess 23 Exporting to a USB storage device ou csesssssescssesessseecssseeesseeccsseecsseeessneenses 23 Imaging modes and exams available by transducer 0 sssssescssesecseeeerseseenee 24 Chapter 4 Measurements and Calculations Measurements inienn a E EEE AEE ANASO EEE a NESANS 25 About saving measurements IMT and OB exam sssssssssssssssssssessessss 25 Working with calipers cesssesssscsssecsscccssssssccsescssscessecsscsssscessecsuceeaserseeesscesseenss 25 WEEET aS M EE EE S 26 Calculation S setsssdcsiessvosssssbvsssssecosssdsoncosdssnsedbessessusesesbosessesnscustbaseoassnsstuursissedsensesseisesvorsie 27 IMT calculations scsssssssocssssscsovsonsossonsscssasossonssbssnssessscsotnoseessesesssonssesecsnbvessensssvonven 27 OB Cal CUlATIOMS vsssscascussasssssnaseessscvssassessdenssbsesosnsstsebusdvatesssososncsb edesdosssavesadedessstvseas 29 Patient re pOL ces secsccsesitGesscascetscescensestttencesvecsecserevecesstiessssaestdesueecessthete evastteenteeeteaye 31 Chapter 5 Troubleshooting and Maintenance TOUTES MOOTHING assis sctsccsscadesedeisidtsccncshtdddecscoschideccesitbsddesescissbbstensbetdedsbiacesctctersbattoeadee 33 Software LICENSING vissiin ii a 33 Maintenance sssessssssssssssess 34 Cleaning and disinfecting s ssssssssesss
25. for Diagnostic Ultrasound Equipment NEMA UD2 2004 e Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment NEMA UD3 2004 e Guidance on the interpretation of TI and MI to be used to inform the operator Annex HH BS EN 60601 2 37 Chapter 6 Safety 55 Ayayes Transducer surface temperature rise Table 6 lists the measured surface temperature rise from ambient 23 C 3 C of transducers used on the ultrasound system The temperatures were measured in accordance with EN 60601 2 37 section 42 with controls and settings positioned to give maximum temperatures Table 6 Transducer Surface Temperature Rise External Use C Test C1in C60n L25n L38n P21n Still air 15 3 15 9 15 8 14 8 16 6 Simulated use 8 5 9 1 9 7 9 4 9 1 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 from its Bioeffects Committee Bioeffects Considerations for the Safety of Diagnostic Ultrasound J Ultrasound Med Sept 1988 Vol 7 No 9 Supplement The report sometimes referred to as the Stowe Report reviewed available data on possible effects of ultrasound exposure Another report Bioeffects and Safety of Diagnostic Ultrasou
26. for the imaging mode and exam type are selectable OB HC and AC use an ellipse for measuring circumference 3 Tap Save See also IMT calculations on page 27 and OB calculations on page 29 Working with calipers When measuring you work with calipers Results based on the calipers position appear at the bottom of the screen The results update as you reposition the calipers You can have two 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 you must accurately place the calipers To position calipers You can position calipers using the knob touchscreen or both In general the knob allows more precise placement Chapter 4 Measurements and Calculations 25 s UsWaiNseayy With the measurement active do any of the following e Knob Turn the knob Tap Left Right Up Down or Small Large if present as necessary to set the behavior e Touchscreen Tap Touch screen Using your finger drag the active caliper You can also use the knob as needed To return to the previously displayed controls press the knob To switch the active calipers Do one of the following e To switch the active caliper within a set tap Select e To switch the active set
27. form You can edit patient information if the exam has not been exported See also To edit patient information from the patient list on page 22 1 In 2D tap Patient 2 Make changes as desired 3 Tap one of the following e Cancel to undo changes and return to imaging e 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 on page 21 2 In 2D tap Patient 3 Tap New End A new patient information form appears Patient information form fields Patient e Last First Middle Patient name e ID Patient identification number e Accession Enter number if applicable e Gender e Date of birth Exam e Type Exam types available depend on transducer See Imaging modes and exams available by transducer on page 24 e LMP Estab DD OB exam Select LMP or Estab DD and then enter either the date of the last menstrual period or the established due date The LMP date must precede the current system date e BP Blood pressure IMT exam e HR Heart rate IMT exam e Ethnicity IMT exam Other e User e Institution Images Saving images When you save an image the image saves to internal storage The system beeps if Beep Alert is on and the percentage icon flashes See Audio Battery setup on page 12 The percentage icon shows the percentage of space available in internal storage To
28. frequency and receives at a higher harmonic frequency to reduce noise and clutter and improve resolution A device that transforms 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 AC Abdominal Circumference AFI Amniotic Fluid Index BPD Biparietal Diameter Crd Cardiac CRL Crown Rump Length FHR Fetal Heart Rate FL Femur Length Gen General an optimization setting GS Gestational Sac HC Head Circumference HL Humerus Length IMT Intima Media Thickness MB SonoMB MI Mechanical Index Msk Musculoskeletal Nrv Nerve OB Obstetrical Pen Penetration an optimization setting Plaq Plaque Q Quadrant Res Resolution an optimization setting SmP Small Parts Sup Superficial Glossary 83 Aiessoj5 84 Abbreviations in User Interface Continued Abbreviation Definition THI Tl Tri Vas Ven LMP Estab DD Tissue Harmonic Imaging Thermal Index Trimester Vascular Venous Last Menstrual Period Esta
29. 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 intensity 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 52 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 2008 Annex HH Chapter 6 Safety 51 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 informat
30. is used for general reporting purposes therefore the In Situ value commonly reported uses the formula In Situ derated Water e 0 069 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 operating 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 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 em MHz throughout the beam path is commonly used when estimating exposure levels
31. of 93 42 EEC Attention see the user guide Device complies with relevant Australian regulations for electronic devices Batch code date code or lot code type of control number Biological risk Device complies with relevant Brazilian regulations for electro medical devices Canadian Standards Association The C and US indicators next to this mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in Canada and the US respectively Catalog number Collect separately from other household waste see European Commission Directive 93 86 EEC Refer to local regulations for disposal Contents sterilized using ethylene oxide process Chapter 6 Safety 71 Ayayes 72 Table 18 Labeling Symbols Continued Symbol Definition S Corrugated recycle Corrugated Recycles JESI toad ey o OO 00 00 gt gt ay GEL STERILE 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 Fragile Gel sterilized by radiation Table 18 Labeling Symbols Continued Definition QOS BP Hot Device emits a static DC magnetic field Non ionizing radiation Paper recycle Serial number type of
32. 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 exhibits erratic or inconsistent behavior Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use information concerning MI and TI 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 Chapter 6 Safety 45 Ayayes Hazardous materials WARNING The liquid crystal display LCD contains mercury Dispose of the LCD properly in accordance with local regulations 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 2007 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation Caution 46 Medical electrical equipment requires special precautions regarding EMC and must be installed and o
33. that contain natural rubber Some gels and sterilants can cause an allergic reaction on some individuals Caution To avoid damage to the transducer use only gels recommended 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 35 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 apply 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 apply 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
34. to a USB storage device overwrites any existing log txt file 1 Insert a USB storage device 2 Tap Log and then tap Export A list of USB devices appears Select the USB storage device and tap Import 3 Select the USB storage device and tap Export The Event log is a text file that you can open ina text editing application for example Microsoft Word or Notepad To clear the Event log 1 Display the Event log 2 Tap Clear 3 Tap Yes Logging in as user If user login is required the User Login screen appears when you turn on the system See To require user login on page 10 To log in as user 1 Turn on the system 2 Inthe User Login screen type your name and password and tap 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 select Guest To change your password 1 Turn on the system 2 Inthe User Login screen tap Password 3 Type your old and new passwords confirm the new password and then tap 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 11 dnjas Annotations setup On the Annotations setup page you can customize predefined labels and set the preference for managing text when unfreezing images For instructions to an
35. ultrasound is transmitted and reflected signals are displayed as dots of varying intensities which create lines across the screen To display the M line 1 Tap Mode and select M Mode 2 Using your finger drag the M line where desired Chapter 3 Imaging 17 3 Adjust controls as desired Many optimization and depth settings available in 2D imaging are also available in M Mode imaging See 2D controls on page 17 To display the M Mode trace 1 Display the M line 2 Adjust the depth if necessary See To adjust depth on page 18 3 Do either of the following e Tap M Mode on the left Tap Mode and select M Mode The time scale above the trace has small marks at 200 ms intervals and large marks at one second intervals 4 Doany of the following as needed e Select the sweep speed Slow Med or Fast e Tap Update M Mode and Update 2D to toggle between the M line and M Mode trace CPD and color Doppler imaging 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 display the CPD or Color image 1 Tap Mode and select Color For CPD tap CPD on the left A region of interest ROI box appears in the center of the 2D image In Color imaging the Color indicator bar in the upper left hand scr
36. 01 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 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 Elect
37. 14 Transducer Model P21n 5 1 Operating Mode M Mode TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 2 a 1 4 1 1 Pr3 MPa 1 841 Wo mW 80 66 80 66 min of W 3 z1 lta 3 Z1 mW Z cm a eae g z Zbp cm g E Zsp cm 3 5 S zalm 4 9 2 deg Zsp cm 0 84 fe MHz 2 26 1 95 1 95 Dim of Aaprt X cm 1 97 1 97 Y cm 1 3 1 3 PD usec 0 311 S PRF Hz 800 8 P Pllmax MPa 2 7 amp deq Pllmax cm 0 68 Focal Length FL cm 18 46 5 Fly cm 5 5 Ipa 3 M max W cm 299 8 5 Control 1 Exam Type Abd Abd Abd 2 Control 2 2D Optimization Pen Pen Pen Control 3 Depth 7 5 cm 35 cm 35 cm S 2 Control 4 THI Off Off Off i S Control 5 MB Multi Beam ae e ae 66 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 Table 15 Transducer Model P21n 5 1 Operating Mode CPD Color
38. 816 3 08 FRO815793 FRO875203 FRO881492 FR1175713 FR1180970 FR1589878 GB0875203 GB0881492 GB1175713 GB1180970 GB1180971 GB1589878 IT0815793 IT0881492 IT1175713 IT1589878 KR528102 KR532359 NO326202 NO326814 NZ542968 RCD000897368 0001 SP0815793 SP0881492 SP1589878 Patents pending P12529 03 06 2010 Copyright 2010 by SonoSite Inc All rights reserved Contents Introduction CONVENON Sinsen EE ERRES vii Customer COMMENTS i scscsscsssssescacessoscesescevscctssncassnasesnvacssesiseoaceiosadssseebsactosnczsesaiesnsatiies vii Chapter 1 Getting Started Ao t the systeM isasremenennnan na ari Ea 1 Preparing the SYSTEM siisii sridi iisi inisesin dionis Compartments and connectors Installing or removing the battery EEE Using AC power and charging the battery EE A EE 3 Turning the system on OF Off eesssssssssseessssesssssesssscessssesssesssssessessssssneeeeesessssee 3 Connecting transducers ccccssscsseccseccsscssssccssecssccsseecseccssccenccesscesscesasesssecsueeeseeess 3 Inserting and removing USB storage devices ssssssssssssssssssssrsssssessrsresssssesee 4 Sereni layout sasssssssassssascesosssavaseensassstasigendascsassoseastesusssseaseseaeonsosssssusscuoassstacebbeusssedsscoedssitens 5 General INCELACKION ssssscissecassesessssoussctecssscaseonnaegncnassaesesnonssconsdesosuascdovscaossassnsvbsbaadeddscessaaas 5 TOUCHSCIOGIN sssscssscsssscasscacesonnsssesssccsoassstaesypsevstsassesosssa
39. N 60601 1 Class I internally powered equipment requirements and Type BF isolated patient applied parts safety requirements 42 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 8 Specifications 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 EN 60601 1 limits for patient contact therefore only the operator shall handle the system This does not include the transducer face 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 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 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 mus
40. NanoMaxx Ultrasound System User Guide CE 0086 BSonosite NanoMaxx 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 NanoMaxx SiteLink SonoCalc SonoHD SonoMB SonoSite and the SonoSite logo are registered trademarks or trademarks of SonoSite Inc DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information The SonoSite ultrasound system referenced in this document may be covered by one or more of the following U S patents 5722412 5817024 5893363 6135961 6203498 6364839 6371918 6383139 6416475 6447451 6471651 6569101 6648826 6575908 6604630 6817982 6835177 6962566 7169108 7449640 7534211 7549961 7588541 7591786 7604596 7643040 D456509 D461895 D509900 D538432 D544962 D558351 D559390 D591423 D592750 D592760 and by the following counterpart foreign patents AU727381 AU730822 CA2372158 CA2373065 CN ZL 97113678 5 CN ZL 98106133 8 CN ZL 98108973 9 CN ZL 200830007734 8 DE60021552 0 DE60029777 2 DE60034670 6 DE69730563 5 DE6980539 6 DE69831698 3 DE60 2004 23
41. PRF Hz 1600 P Pll max MPa 2 88 Xe deq Pllmax cm Focal Length FL cm 3 amp 5 FLy cm Ip 3 M max W cm 225 8 iS Control 1 Exam Type Abd E w Control 2 2D Optimization Pen Control 3 Depth 7 8 S 2 Control 4 THI Off O S Y Control 5 MB Multi Beam amp Off 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 60 Table 9 Transducer Model C60n 5 2 Operating Mode CPD Color TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 1 a b Pr3 MPa 1 95 Wo mW min of W 3 z1 lTA3 Z1 mW UV 7 Z1 cm 3 g z Zbp cm Zsp cm amp z PIl 3max 5 1 2 deg Zsp cm fe MHz 2 86 Dim of Aaprt X cm Y cm PD usec 0 58 3 PRF Hz 1249 2 P Pll max MPa 3 22 S deq Pllmax cm Focal Length FL cm ep pi ot 5 FLy cm a a Ip 3 MI max W cm 226 0 Control 1 Mode CPD or Fo Color g yw Control 2
42. SB storage device or turning off the system while exporting may cause exported files to be corrupted or incomplete To stop in progress exporting tap Cancel Export 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 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 24 Imaging modes and exams available by transducer To change the exam type Do one of the following e In 2D imaging tap Exam and select the exam type e On the patient information form select the exam type in the Type list under Exam See Patient information form on page 20 Imaging modes and exams available Imaging mode Exam 2D Transducer type M Mode Color CPD Clin Abd Vas C60n Abd Gyn Nrv OB L25n IMT Msk Nrv Sup Vas Ven L38n IMT MSK Nrv SmP Vas Ven P21n3 Abd Crd OB X XK KKK KK KOK KK KK KOK KKK KK X XK KKK KK KOK KK KK KOKO KK KK X KKK KK KOK OK KKK KOK KKK XxX XxX x lt x lt X 1 Exam type abbreviations Abd Abdomen Crd Cardiac Gy
43. Site 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 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 dis the recommended separation distance in meters m Chapter 6 Safety 49 Ayayes Table 2 Manufacturer s Declaration Electromagnetic Immunity Continued Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment a Radiated RF IEC 61000 4 3 continued Note Uy is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies Field strengths from fixed RF transmitters as determined by an electromagnetic Site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol IEC 60417 No 417 IEC 5140 Sour
44. The current optimization setting transducer and exam type See Imaging modes appears below the icon and exams available by transducer on page 24 Res provides the best resolution Gen provides a balance between 2D imaging resolution and penetration 2D is the system s default imaging mode The Pen provides the best penetration system displays echoes in two dimensions by Some of the parameters optimized to assigning a brightness level based on the echo provide the best image include focal signal amplitude To achieve the best image zones aperture size frequency quality properly adjust the screen brightness center and bandwidth and gain depth and viewing angle Also use a waveform suitable optimization setting and exam type THI Turns Tissue Harmonic Imaging on and off When Tissue Harmonic Imaging is on THI appears on screen This feature is To display the 2D image 1 Do any of the following e Turn on the system optional and depends on transducer e Tap Mode and select 2D and exam type 2 Adjust the image as needed MB On MB On and MB Off turn SonoMB oe MB Off technology on and off When SonoMB See 2D controls on page 17 and Adjusting technology is on MB appears depth and gain on page 18 on screen in the status area See also Adjusting depth and gain on page 18 M Mode Motion mode M Mode is an extension of 2D It provides a trace of the 2D image displayed over time A single beam of
45. 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 Chapter 6 Safety 57 Ayayes of fluid as in many first and second trimester pregnancies scanned transabdominally this model may underestimate 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 em 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 e A survey 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 e Computed estimates of upper limits to temperature elevatio
46. abel tap Label and then tap the desired label group A x x B x x or C x x Turn the knob to select the label The first number shows which label in the group is selected The second number is the number of labels available See Annotations setup on page 12 To return to the previous screen tap Back Chapter 3 Imaging 19 To reset the home position The home position is where the cursor initially appears 1 Tap Annotate and select Text A green cursor appears 2 Drag the cursor where desired 3 Tap Home Set To return to the previous screen tap Back To place an arrow You can add an arrow graphic to point out a specific part of the image 1 Tap Annotate and select Arrow 2 Adjust the arrow s orientation as needed Tap Rotate Arrow and then turn the knob 3 Drag the arrow where desired To remove the arrow tap Hide Tap Show to display it again To return to the previous screen tap Back To place a pictograph The pictograph set available depends on transducer and exam type 1 Tap Annotate and select Picto 2 Turn the knob to display the desired pictograph The first number shows which pictograph in the set is selected The second number is the number of pictographs available Drag the pictograph marker where desired 4 Rotate the pictograph marker as needed Tap Rotate Marker and then turn the knob 5 Tap Position for a screen location for the pictograph U L Up Left D L Do
47. able enters the connector Follow the instructions on the disinfectant label for the duration of the transducer immersion 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 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 or dock 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 the battery or dock wipe method 1 Remove the battery or dock 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 4 Air dry or towel dry with a clean cloth Chapter 5 Troubleshooting and Maintenance 37 BuljooysajqnosL 38 Cleaning and disinfecting 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 access
48. access saved images display the patient list See Reviewing patient exams To save an image Tap Save Reviewing patient exams 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 vii The patient list lets you organize saved images The patient list is organized in columns including Name ID Date Time and number of images saved Chapter 3 Imaging 21 v Nome Date Time PATIENT 20100 c15 04 06 PATIENT2 20100 c15 04 06 PATIENTS 20100ectS 4417 Select All Review Figure 1 Patient list To display the patient list 1 In 2D do one of the following e Tap Options then select Review e Tap Patient and then tap Review 2 If there is a current patient tap List To sort the patient list After the system starts the patient list is arranged by date and time with the most recent patient exam first You can re sort the patient list as needed Tap the column heading that you want to sort by Tap it again if sorting in reverse order Note The selection column Sf is sortable To select patient exams in the patient list K Tap one or more patient exams Tapping Select All selects all patient exams Selected patient exams have a check mark in the first column To deselect patient exams tap them or tap Clear All 22 Images To ed
49. aks However simply changing tasks can help some muscle groups relax while others remain or become active e 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 e 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 for you Electrical safety classification Class equipment Internally powered equipment Type BF applied parts IPX 7 watertight equipment Non AP APG The ultrasound system is classified as Class equipment when powered from the power supply or mounted on the stand because the external power supply is a Class protectively earthed power supply The stand has no protective earth Ground bond testing is not applicable to the ultrasound system or the stand Note AC powered peripherals that may be used with the system are Class and are individually protectively earthed Ground bond testing may be conducted on each AC powered peripheral Ultrasound system not connected to the power supply battery only Ultrasound transducers Ultrasound transducers Ultrasound system power supply V Universal Stand and peripherals Equipment is not suitable for use in the presence of flammable anaesthetics Chapter 6 Safety 41 Ayayes Electrical safety This system meets E
50. and then tap Select See To position calipers on page 25 A second caliper appears Position the second caliper 4 Optional For additional calipers see To add calipers in M Mode on page 27 See To save a measurement to a calculation and patient report on page 25 To measure heart rate M Mode 1 Ona frozen M Mode trace tap Calipers 2 Tap CO HR A vertical caliper appears 3 Position the vertical caliper at the peak of the heartbeat and then tap Select See To position calipers on page 25 A second vertical caliper appears 4 Position the second vertical caliper at the peak of the next heartbeat Tapping Select toggles between the calipers See also To measure fetal heart rate FHR on page 31 To add calipers in M Mode With a measurement active you can add calipers to perform additional measurements Tap one of the following Caliper to measure distance The second measurement is labeled B e QI HR to measure heart rate Other measurements are cleared from the screen To delete or edit a measurement With the measurement active highlighted do one of the following e To delete the measurement tap X Delete e To edit reposition the calipers where desired If the measurement is unavailable tap Back to reach the proper screen Calculations Measurements you take for calculations save to the patient report You can display redo and delet
51. at 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 battery 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 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 Dispose of the battery in accordance with local regulations Clinical safety WARNING Non medical commercial grade peripheral monitors have not been verified or validated by SonoSite as being
52. ation 50 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 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 st
53. blished Due Date Index Numerics 2D imaging 17 A abbreviations 83 abdominal intended uses 7 accessories list 79 acoustic measurement precision 70 acoustic output measurement 56 tables 58 terms in tables 68 acquisition error 75 add new user 10 Administrator 9 AE Title DICOM 14 age gestational 30 airborne equipment standards 80 ALARA principle 50 51 81 alerts storage 13 annotations place 19 predefine label groups 12 arrow graphic 20 audio 2 12 battery charge 3 clean 37 install or remove 2 safety 44 setup 12 specifications 80 biological safety 45 Biopsy 19 brightness screen 20 C cables connect power 3 calculations about 27 IMT 27 OB 29 calipers 25 27 cardiac intended uses 7 Carotid IMT 25 cautions definition vii CIMT 25 cine buffer 19 clean battery 37 system 34 touchscreen 35 transducers 35 color Doppler Color imaging 18 color power Doppler CPD imaging 18 Color See color Doppler Color imaging connectivity setup 12 control keys 5 controls direct 51 indirect 52 receiver 52 CPD See color power Doppler CPD imaging customer assistance vii D date setup 13 default settings 9 depth adjust 18 definition 81 marker 5 13 DICOM 14 disinfect battery 37 system 34 transducers 35 distance measurements 26 E electrical safety 42 electromagnetic compatibility 46 electromechanical safety standards 80 EMC classification standards 80 equipment safety 44 Index 85
54. ce of non ionizing radiation These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed 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 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 examin
55. component measurements from the measurement tables Estimated Date of Delivery EDD by Average Ultrasound Age AUA Results are displayed as month day year EDD system date 280 days AUA in days Estimated Date of Delivery EDD by Last Menstrual Period LMP The date entered into the patient information for LMP must precede the current date Results are displayed as month day year EDD LMP date 280 days Estimated Fetal Weight EFW Hadlock F et al Estimation of Fetal Weight with the Use of Head Body and Femur Measurements A Prospective Study American Journal of Obstetrics and Gynecology 151 3 February 1 1985 333 337 76 Measurement publications Shepard M J V A Richards R L Berkowitz et al An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound American Journal of Obstetrics and Gynecology 142 1 January 1 1982 47 54 Gestational Age GA by Last Menstrual Period LMP The gestational age derived from the LMP date entered on the patient information form Results are displayed in weeks and days and are calculated as follows GA LMP System date LMP date Gestational Age GA by Last Menstrual Period LMPd Derived from Established Due Date Estab DD Same as GA by Estab DD The gestational age derived from the system derived LMP using the Established Due Date entered on the patient information form Results are displayed in weeks
56. cvestbesies 80 Glossary TKI ssssssssssssscsesscusscasssesssoasssnsscossovss sossansgnszsonssshsssanssoaacoasscodsseossesesoansshevesnasdasssazssoasebaayes 81 ADDIOVI ati OMS cassssssscsscecasscscesssesssstucscssusssosugsenussb visenassconstssisassdbascesoabenrenssnsaisceateceoasensaeeed 83 DRDO E EE E E A EA 85 vi Introduction This NanoMaxx Ultrasound System User Guide provides information on preparing and using the NanoMaxx 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 e A WARNING describes precautions necessary to prevent injury or loss of life e A Caution describes precautions necessary to protect the products e Numbered steps in procedures must be performed in order e Items in bulleted lists do not require a sequence e Single step procedures begin with Symbols and terms used on the system and transducer are explained in Chapter 1 Chapter 6 and Glossary Cus
57. d 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 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 pronged end of the battery into the end of the battery compartment near the handle 3 Push down on the locking lever until the battery snaps securely in place To remove the battery 1 Disconnect the power supply from the ultrasound system 2 Holding the system backside down carefully push down the locking lever and catch the battery as it drops from the compartment 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 The system can run on battery power for up to two hours depending on the imaging mode and the display brightness When running on battery power the system may not restart if the battery is low To continue connect the system to AC power If users in the United States connect the equipment to a 240V supply system the equipment shall be connected to a center tapped single phase supply circuit WARNING
58. e 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 FDA 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 Cleaning and disinfecting For a list of recommended disinfectants see the SonoSite Web site at www sonosite com 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 WARNING 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 Caution Do not spray cleaners or disinfectant directly on the system 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 surfac
59. e saved measurements from a calculation For exam type availability see Imaging modes and exams available by transducer on page 24 IMT calculations WARNING To ensure high quality images all patient images must be obtained by qualified and trained individuals To avoid patient injury IMT results should not be used as a sole diagnostic tool All IMT results should be interpreted in conjunction with other clinical information or risk factors To avoid measurement errors all measurements must be of the common carotid artery CCA This tool is not intended for measuring the bulb or the internal carotid artery ICA To avoid incorrect calculations verify that the patient information date and time settings are accurate To avoid misdiagnosis or harming the patient outcome start a new patient information form before starting a new patient exam and performing calculations Starting a new patient information form clears the previous patient s data The previous patient s data will be combined with the current patient if the form is not first cleared See To create a new patient information form on page 20 Chapter 4 Measurements and Calculations 27 s UsWaiNseayy To perform an IMT measurement Repeat this procedure for each IMT measurement you want to take 1 2 28 On a frozen 2D image tap Calcs Tap Right or Left for the side measured The setting displayed is the side measured
60. ed Analysis of Multiple Fetal Growth Parameters Radiology 152 1984 497 501 Hansmann M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1985 440 Osaka University Ultrasound in Obstetrics and Gynecology July 20 1990 98 University of Tokyo Shinozuka N FJSUM et al Standard Values of Ultrasonographic Fetal Biometry Japanese Journal of Medical Ultrasonics 23 12 1996 885 Crown Rump Length CRL Hadlock F et al Fetal Crown Rump Length Re evaluation of Relation to Menstrual Age 5 18 weeks with High Resolution Real Time Ultrasound Radiology 182 February 1992 501 505 Hansmanmn M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1985 439 Osaka University Ultrasound in Obstetrics and Gynecology July 20 1990 20 and 96 Tokyo University Gestational Weeks and Computation Methods Ultrasound Imaging Diagnostics 12 1 1982 1 24 25 Table 3 Femur Length FL Chitty L S and D G Altman New charts for ultrasound dating of pregnancy Ultrasound in Obstetrics and Gynecology 10 1997 174 179 Table 8 186 Hadlock F et al Estimating Fetal Age Computer Assisted Analysis of Multiple Fetal Growth Parameters Radiology 152 1984 497 501 Hansmamn M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1985 431 Osaka Univer
61. een displays velocity in cm s 18 Adjusting depth and gain 2 Drag 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 13 Tap Ay and turn the knob e Clockwise increases the displayed depth e Counterclockwise decreases the displayed depth To adjust gain automatically Tap Auto Gain The gain adjusts each time you tap the control To adjust gain manually 1 Doone of the following e 2D or M Mode Tap ay Gain to select a setting e Gain adjusts the overall gain applied to the entire image e Near adjusts the gain applied to the near field of the 2D image e Far adjusts the gain applied to the far field of the 2D image e Color CPD Tap pr Gain This control affects the color gain applied to the ROI box 2 Turn the knob e Clockwise increases gain e Counterclockwise decreases gain To revert to the default 2D gain setting Tap Reset ps This control may be on a page different from the gain controls Freezing viewing frames and zooming To freeze or unfreeze an image Tap Freeze or Unfreeze To move forward or backward in the cine buffer 1 Freeze the image 2 Tap The number of frames appears below the cine icon
62. ephalic 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 63 Ayayes Table 12 Transducer Model L38n 10 5 Operating Mode CPD Color TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 1 1 b Pr3 MPa 3 21 Wo mW 47 37 min of W z hta 3 Z1 mW V rd Z1 cm S pa g z Zbp cm E Zsp cm S amp Z PIl 3max 0 8 i 2 deqlZsp cm fe MHz 4 79 4 81 Dim of Aaprt X cm 0 42 Y cm 0 4 PD usec 0 55 S PRF Hz 13705 z Pr PIl max MPa 3 66 S deq Pllmax cm _ Focal Length FL cm 1 16 ep on E FL cm 2 5 Ip 3 MI max W cm 525 8 _ Control 1 Mode CPD or CPD or Color Color 5 Control 2 Exam Type SmP SmP D E Msk Msk c O Control 3 2D Optimization Pen Res of Y Control 4 Depth 2 0 cm 2 0 cm 9 Control 5 Color Box Default Default 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 maxim
63. es 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 touchscreen To clean the touchscreen K2 ye 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 2 Turn off the system Disconnect the system from the power supply or remove it from the stand 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 Mix the disinfectant solution compatible with the system following disinfectant label 5 6 instructions for solution strengths and disinfectant contact duration Wipe surfaces with the disinfectant solution Air dry or towel dry with a clean cloth Cleaning and disinfecting transducers To disinfect the transducer and its cable use the immersion method or the wipe method Immersible transducers can be disinfected only if the product labeling indicates they can be used with an immersion method WARNING Caution To avoid electrical sh
64. essdeasanassacausoesavednasessnouassoaaqensasee 52 Receiver GOMEMOIS sscsssssssssscascscanssssevascsnsvsssnes snenschnsserbaudsnabsnsadsetesscuadessnoesssoaasetveees 52 ACOUSTIC APCIFACES enrere a AREARE A 52 Guidelines for reducing MI and Tl sssssssssssssssssssssseessrssesssesssssssssssssssssssesseeesrrrereeee 52 Output display eseecsscsssesssesseccseecseecsees 54 MI and TI output display ACCULACY ssssssessssssssssssresssss 54 Factors that contribute to display uncertainty DD Related Guidance documents essssesccssescssesccsseecssscccsseecsseccsssesessesessseeesseees 55 Transducer surface temperature rise ssecssscsssecseecsssecseccsscssasesseecsscssseessecssaeessee 56 ACOUSTIC output measurement sesssssssssssssseeesssssssssssssssesssteterrreessssssssssssessessrrreesese 56 In Situ derated and water value intensities sssssssssessseeessssssccessssseeersse 56 Tissue models and equipment SULVEY ssssssssessssssssssesesssssseseeessssssesresssssss 57 ACOUSTIC output TADIES eeseeesseeccssecssssesecssecssccsseccssccssccssecenecesscessessseeesseessees 58 Terms used in the acoustic output tables ou ecsesssecssecsseecsessseceseecsseees 68 Acoustic measurement precision and uncertainty on escsecceseeseeeeeees 70 babeling SYIMADOIS cassssisisssudscsdscsciteasdtusssnatoscsusctvasssdeucsevibsossstcviasestussesdtatessasieassetbassuunsten 71 Chapter 7 References Measurement accuracy esssesc
65. ext or Clear All Text The default setting is Keep All Text See also To reset the home position on page 20 To calibrate the touchscreen If the touchscreen s response seems out of alignment or imprecise you can calibrate the touchscreen On the Presets setup page tap Calibrate for Touchscreen and follow the on screen instructions System Information setup The System Information setup page displays patents system hardware and software versions and license information See also To enter a license key on page 34 Chapter 2 System Setup 13 dnjas USB Devices setup On the USB Devices setup page you can view information about connected USB devices including space availability You can also specify the following e File format for images in patient exams that you export to a USB storage device e How patient exams export to a USB storage device e AE title Application Entity title if exporting images for DICOM use To specify a file format for exported images 1 On the USB Devices setup page tap Export 2 Under USB Export select an export type e SiteLink organizes files in a folder structure similar to that from SiteLink image manager e DICOM creates files readable by a DICOM reader 3 Select an image format for your export type For JPEG image format also select a JPEG compression A high compression has a smaller file size but less detail 4 For SiteLink export type
66. gle of the system and display to minimize glare e If using a stand adjust its height so that the display is at or slightly below eye level Position yourself 40 Support your back during an exam e Use a chair that supports your lower back that adjusts to your work surface height that promotes a natural body posture and that allows for quick height adjustments e Sit or stand upright Avoid bending or stooping Minimize reaching and twisting e Use a bed that is height adjustable e Position the patient as close to you as possible e Face forward Avoid twisting your head or body e Move your entire body front to back and position your scanning arm next to or slightly in front of you e Stand for difficult exams to minimize reaching e Position the ultrasound system directly in front of you Promote comfortable shoulder and arm postures e Keep your elbow close to your side e Relax your shoulders in a level position e Support your arm using a support cushion or pillow or rest it on the bed Promote comfortable hand wrist and finger postures e Hold the transducer lightly in your fingers e Minimize the pressure applied on the patient e Keep your wrist in a straight position Take breaks exercise and vary activities e 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 bre
67. he Gestational Age is automatically calculated and displayed next to the OB measurement you selected The average of the Tokyo U results is the AUA b The Estimated Fetal Weight calculation uses an equation that BPD Chitty consists of one or more fetal biometry measurements The Hadlock author for the OB tables which you choose on a system setup Hansmann page determines the measurements you must perform to Osaka obtain an EFW calculation See OB Calculations setup on Tokyo U page 13 Individual selections for Hadlock s EFW equations 1 2 and 3 HC Chitty are not determined by the user The selected equation is Hadlock determined by the measurements that have been saved to H g the report with priority given to the order listed above ansmann AC Hadlock To measure gestational growth Hansmann For each OB measurement the system saves up Tokyo U to three individual measurements and their average If you take more than three FL Chitty measurements the earliest measurement is Hadlock deleted Hansmann Osaka 1 Inthe patient information form select OB Tokyo U exam type and select LMP or Estab DD See Patient information form on page 20 HL Jeant y 2 Ona frozen 2D image tap Calcs Estimated HC AC FL Hadlock 1 i Fetal 3 Do the following for each measurement you Weight BPD AC FL Hadlock 2 want to take EFW AG FL Hadlock 3 a Tap the control and select a measurement BPD AC Shepard e First Tri GS CRL
68. ies that may facilitate the onset of MSDs This section provides guidelines that may help you work more comfortably and may reduce your risk of MSDs 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 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 e Habes DJ and S Baron Health Hazard Report 99 0093 2749 University of Medicine and Dentistry of New Jersey 1999 Chapter 6 Safety 39 Ayayes 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 e If possible position the system within reach e Adjust the an
69. ine 3 February 1984 75 79 78 Measurement publications Chapter 8 Specifications This chapter contains system and accessory specifications and standards The specifications for recommended peripherals are in the manufacturers instructions Supported transducers e C11n 8 5 MHz 6 ft 1 8 m e C60n 5 2 MHz 5 5 ft 1 7 m e L25n 13 6 MHz 7 5 ft 2 3 m e L38n 10 5 MHz 5 5 ft 1 7 m e P21n 5 1 MHz 6 ft 1 8 m Imaging modes e 2D 256 gray shades e M Mode e Color power Doppler CPD 256 colors e Color Doppler Color 256 colors Image storage Internal storage Up to 1800 images Accessories The following items are either included with or available for use on the ultrasound system e Battery e Carry case e Dock e Needle guide e Power supply e System AC power cord 10 ft 3 1 m e V Universal Stand Peripheral The following medical grade conforming to EN 60601 1 requirements product is available for use with the ultrasound system Black and white printer To order printer paper and other supplies or to find the local distributor contact Sony at www sony com digital photofinishing Manufacturer s instructions accompany each peripheral Environmental limits Operating System battery and transducer 10 40 C 50 104 F 15 95 R H 700 to 1060hPa 0 7 to 1 05 ATM Shipping and storage System and transducer 35 65 C 31 149 F 15 95 R H 500 to 1060hPa 0 5 to 1 05 ATM
70. inear 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 distance measurement components have the accuracy and range shown in the following table 2D Measurement Accuracy and Range 2 xo _ v v gt te Fe 8 E ag 26 a v v N 5 5 gm D ag U pr lt 6 n o x v 6 v U a Axial Distance lt 2 plus Acquisition Phantom 0 26cm 1 of full scale Lateral lt 2 plus Acquisition Phantom 0 35 cm Distance 1 of full scale Diagonal lt 2 plus Acquisition Phantom 0 44cm Distance 1 of full scale a Full scale for distance is defined as the maximum depth of the image displayed b An RMI413a model phantom with 0 7 dB cm MHz attenuation was used Sources of measurement errors In general two types of errors can be introduced into the measurement Acquisition Error Includes errors introduced by the ultrasound system electronics 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
71. ion 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 include e Shadowing e Through transmission e Aliasing e Reverberations e 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 52 The following are general guidelines for reducing MI or TI If multiple parameters are given the best results may be achieved by minimizing these parameters simultaneously In some modes changing these parameters does not affect MI or TI Changes to other parameters may also result in MI and TI reductions Please note the MI and TI values on the right side of the screen Table 3 MI Transducer Depth Clin T C60n T L25n T L38n T P21n T Decrease or lower setting of parameter to reduce MI T Increase or raise setting of parameter to reduce MI Table 4 TI TIS TIC TIB CPD Settings Transducer Bok Depth Depth Optimize C11n i i C60n i i L25n L38n P21n T Decrease or lower setting of parameter to reduce Tl T Increase or raise setting of parameter to reduce TI Data are not applicable Chapter 6 Safety 53 Ayayes Output d
72. iopsy and drainage procedures vascular line placement peripheral nerve blocks spinal nerve blocks and taps amniocentesis and other obstetrical procedures and to provide assistance during abdominal and breast surgery Obstetrical Imaging Applications You can assess the fetal anatomy viability estimated fetal weight gestational age amniotic fluid and surrounding anatomical structures for the presence or absence of pathology transabdominally CPD and color Doppler Color imaging is intended for evaluating the presence or absence of flow Chapter 1 Getting Started 7 pares bunya 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 effective for these two uses CPD or Color images can be used as an adjunctive method not as a screening tool for the following e Detection of structural anomalies of the fetal heart e Diagnosis of Intrauterine Growth Retardation IUGR To avoid errors in fetal growth estimation do not use the system as a fetal growth screening tool The system does not provide fetal growth data Pediatric and Neonatal Imaging Applications You can assess the pediatric abdominal and pelvic anatomy pediatric hips and surrounding anatomical structures for the presence or absence of pathology Superficial Imaging Applications You can assess the breast th
73. is 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 62 Table 11 Transducer Model L38n 10 5 Operating Mode M Mode TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 4 1 2 1 9 b Pr3 MPa 3 23 Wo mW 53 68 35 86 min of W 3 z hta 3 Z1 mW V rA Z1 cm z g g Zbp cm zB Z cm 1 6 g amp Z Pll zmax 0 9 2 deqlZsp cm 0 21 fe MHz 5 07 4 81 5 1 Dim of Aaprt X cm 1 86 0 78 Y cm 0 4 0 4 PD usec 0 32 S PRF Hz 5221 z P Pll max MPa 3 78 S deq Pllmax cm 0 20 Focal Length FL cm 5 54 oD 5 FLy cm 2 5 lIpa 3 Mlmax W cm 602 0 Control 1 Exam Type Vas Any Vas Ven Bra Ven SS Control 2 2D Optimization Pen Pen Pen ox 5 g Control 3 Depth 4 7 cm 9 0 cm 4 7 cm O 5 Control 4 MB Multi Beam gY off off off O a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal c
74. isplay The system meets the AIUM output display standard for MI and TI see last reference in Related guidance documents below Table 5 indicates for each transducer and operating mode if either the TI or MI is greater than or equal to a value of 1 0 thus requiring display Table 5 Tl or MI is gt 1 0 Transducer Model Index 2D M Mode Sea C11n 8 5 MI No No No TIC TIB or TIS No No No C60n 5 2 MI Yes Yes Yes TIC TIB or TIS No No No L25n 13 6 MI No No No TIC TIB or TIS No No No L38n 10 5 MI Yes Yes Yes TIC TIB or TIS No Yes Yes P21n 5 1 MI Yes Yes Yes TIC TIB or TIS No Yes Yes Even when MI is less than 1 0 the system provides a continuous real time display of MI in all imaging modes in increments of 0 1 The system meets the output display standard for TI and provides a continuous real time display of TI in all imaging modes in increments of 0 1 The TI consists of three user selectable indices and only one of these is displayed at any one time In order to display TI properly and meet the ALARA principle the user selects an appropriate TI based on the specific exam being performed SonoSite provides a copy of AIUM Medical Ultrasound Safety which contains guidance on determining which TI is appropriate See Related guidance documents on page 55 MI and TI output display accuracy 54 The accuracy result for the MI is stated statistically With 95 confidence 95 of the measured MI values will be withi
75. it patient information from the patient list You can edit the patient name and ID from the patient list instead of from the patient information form if the exam is closed but has not been exported 1 In the patient list select the patient exam 2 Tap Edit 3 Fill in the form fields and tap OK To append images to a patient exam Although you cannot add images to a patient exam that is ended exported or archived you can automatically start a new patient exam that has the same patient information Depending on your archiver the two exams appear as one study when exported 1 Select the patient exam in the patient list 2 Tap Append A new patient information form appears The form has the same information as the patient exam you selected To review images from the patient list You can review only one patient exam s images at a time 1 Inthe patient list tap the patient exam whose images you want to review The row is highlighted 2 Tap Review Two numbers x x appear the file displayed and the total files saved 3 Turn the knob or tap the arrows lt gt to cycle through images To return to the patient list tap List To return to imaging tap Done To review images for the current patient 1 Tap Options and select Review Two numbers x x appear the file displayed and the total files saved 2 Turn the knob or tap the arrows lt gt to cycle through images To display the patient list tap
76. maximum min W 3 2 lta 3 Z x 1 cm where z gt zbp in centimeters Zbp 1 69 Aapr in centimeters Zsp For MI the axial distance at which p 3 is measured For TIB the axial distance at which TIB is a global maximum for example Z Zp 3 in centimeters Table 16 Acoustic Output Terms and Definitions Continued Term Definition deq z Equivalent beam diameter as a function of axial distance z and is equal to J 4 7 1 Wo 1TA z where lz z is the temporal average intensity as a function of z in centimeters Z PIl zmax The axial distance centimeters corresponding to the maximum of the derated spatial peak pulse intensity integral megapascals 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 Chapter 6 Safety 69
77. may be required Record the number in parentheses on the C line and contact SonoSite or your SonoSite representative Software licensing 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 the system and one key for the transducer 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 license 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 vii You need to provide the following information See System Information setup on page 13 e Name of institution installing the software e Serial number on bottom of system e PCBA serial number e ARM version for system software or transducer package version for transducer software Chapter 5 Troubleshooting and Maintenance 33 BuljooysajqnosL After you obtain a license key you must enter it into the system On occasion a software upgrade may be required So
78. n Gynecology IMT Intima Media Thickness MSK Musculoskeletal Nrv Nerve OB Obstetrical SmP Small Parts Sup Superficial Vas Vascular Ven Venous 2 The optimization settings for 2D are Res Gen and Pen 3 Transducer includes Tissue Harmonic Imaging For more information see Glossary on page 81 Chapter 4 Measurements and Calculations With the NanoMaxx ultrasound system you can take distance measurements on an image In the IMT also called Carotid IMT or CIMT or OB exam you can also take measurements for calculations which save to a patient report Measurements are performed on frozen images For references used see Chapter 7 References 7 Measurements You can take measurements in any imaging mode and can save the image with the measurements displayed Figure 1 2D image with two measurements About saving measurements IMT and OB exam After performing a measurement you can save the image with the measurements displayed See To save an image on page 21 Some measurements can also be saved to a calculation and the patient report If you prefer to select a measurement name before performing a measurement start a calculation See Calculations on page 27 To save a measurement to a calculation and patient report 1 With the measurement active green tap Calcs 2 From the lefthand controls select a measurement name Only measurement names available
79. n 18 to 25 of the displayed MI value or 0 2 of the displayed value whichever value is larger The accuracy result for the TI is stated statistically With 95 confidence 95 of the measured TI values will be within 21 to 40 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 70 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 a sample population of systems and transducers taken from early production units and they are selected based on havi
80. n 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 20 Mode Data Imaging information System Status Power battery connectivity and similar information OB Calculations setup On the OB Calculations setup page you select authors for OB gestational calculation tables See also OB calculations on page 29 To specify gestational age On the OB Calculations setup page select the desired OB authors or select None in the measurement lists under Gestational Age Presets setup The Presets setup page has settings for general preferences You can select from the following lists and can calibrate the touchscreen 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 and all others are TIS Auto save Pat Form Automatically saves the patient information form as an image in the patient s file Unfreeze You can specify which text from annotations to keep when you unfreeze an image or change the imaging layout Select Keep All Text Keep Home T
81. nd dated January 28 1993 provides more current information The acoustic output for this ultrasound system has been measured and calculated in accordance with Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD2 2004 and Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment NEMA UD3 2004 In Situ derated and water value intensities 56 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 e2349 where In Situ In Situ intensity value Water Water intensity value e 2 7183 a attenuation factor dB em MHz Attenuation factor a for various tissue types brain 0 53 heart 0 66 kidney 0 79 liver 0 43 muscle 0 55 l skinline to measurement depth in cm f center frequency of the transducer system mode combination in MHz 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
82. ng 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 related 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 e Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers FDA 2008 e Medical Ultrasound Safety American Institute of Ultrasound in Medicine AIUM 2008 A copy is included with each system e Acoustic Output Measurement Standard
83. nnsssnbesiseasigansassoseanavaisiedaseoasiaas 5 HMO o EREI AE E A E T 6 Entering text samniennieanan unna aa E 6 Preparing CramMSQUCers sasscsiscisccsncssscsussciavscsiacdevassvesusectavecsnssiavavscansssdnansscanscovttecdusaiansnest 6 Intended USES oii scssss cases sci5555ccsssceuacesscdlececsdcteaccesanasscoddecdassvasauuaecassdisctosssdavbiaedbassitescosences 7 Chapter 2 System Setup Displaying the setup pages sssscssssecssesecssescssssccssescssscesssccesssecesscesssesessecesnseeenseees 9 Restoring default settings csccsssscssseccssscscsseccsssessssecssssecsssecssssesssnecssssecssueessssecesseeess 9 Administration Setup seesssssscssesessseecssecesssesesscesssescssscecsseecsnecessseccssesesnseeensesesnseeesses 9 Security SOUEIMNOS dscsssvessesscotvesndscsedssvovsensennsseasecsvssosbveustssussonssbasseheusensteatststnseysisbieens 9 USSF SLID AEE EEN A AA E E E 10 Exporting or importing user ACCOUNKS ssssssssesessessssssssssssssseserteeesssessssssssss 10 Exporting and clearing the Event l09 ssssssssssssssssssessssssssoseessssssssreessssssses 11 LOGGING iN AS USEF oe ecesseesssscssscsecssccsscnscssscnsecsecnsccsccaseesscnsessecsscesccaeessenseeneessees 11 Choosing a secure password sesssesesssecssecssscsssecssccsuessuccenecesscessccsssesaceesseessees 11 Annotations SETUP on eeeessescsscstecsecssecsccssccscccsccssecscessccscensecsccssecseeneessseaseesecaserseenseeneesees 12 Audio Battery setup 12 Connectivity
84. noSite provides a USB device containing the software To enter a license key 1 Turn on the system The license update screen appears 2 Enter the license key in the Enter license key field 3 Tap 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 vii Maintenance Use the recommendations in this document when cleaning or disinfecting the ultrasound system transducer and accessories Use the cleaning recommendations in the peripheral manufacturer s instructions when cleaning or disinfecting 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 35 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 vii 34 Maintenance WARNING The level of disinfection required for a devic
85. notate images see Annotating images on page 19 To predefine a label group You can specify which labels are available for an exam type when annotating an image See To place text or a label on page 19 1 Inthe Exam list on the Annotations setup page select the exam type whose labels you want to specify 2 For Group select A B or C for the label group you want associated with that exam The preset labels for the selected group appear in the scroll list 3 Do any of the following e Add a custom label to the group Select lt New gt from the list type the label in the Text box and tap Add Rename a label Select the label type the new name in the Text box and tap Rename e Move a label within the group Select the label and then tap the up or down arrow Delete a label from a group Select the label and tap Delete See also Entering text on page 6 To export predefined label groups 1 Insert a USB storage device 2 On the Annotations setup page tap Export A list of USB devices appears 3 Select the USB storage device and tap Export A copy of all predefined label groups for all exams saves to the USB storage device 12 Annotations setup To import predefined label groups 1 Insert the USB storage device that contains the label groups 2 On the Annotations setup page tap Import 3 Select the USB storage device and then tap Import 4 Tap OK in the dialog box that appea
86. ns 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 trimester 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 58 The following tables indicate the acoustic output for the system and transducer combinations with a TI or MI 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 68 Table 7 Transducer Model C60n 5 2 Operating Mode 2D TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 1 a b Pr3 MPa 1 95 Wo mW min of W 3 Z ta 3 Z1 mW a V T Z1 cm
87. o the ventilation holes on the back of the system Chapter 6 Safety 43 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 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 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 he
88. ock before cleaning disconnect the transducer from the system To avoid injury always use protective eyewear and gloves when performing cleaning and disinfecting procedures 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 using incorrect solution strength or 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 Chapter 5 Troubleshooting and Maintenance 35 BuljooysajqnosL Caution 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 To clean and disinfect a transducer wipe method 1 2 3 36 Disconnect the transducer from the system Remove any transducer sheath Clean the surface using a soft cloth ligh
89. oreign material in the connector Chapter 1 Getting Started 3 panes buia Figure 3 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 and insert the transducer 3 Turn the latch counter clockwise 4 Press the latch down securing the transducer connector to the system To remove a transducer 1 Pull the transducer latch up and rotate it clockwise 2 Pull the transducer connector away from the system 4 Preparing the system Inserting and removing USB storage devices Images save to internal storage and are organized in a sortable patient list You can archive the images from the ultrasound system to a PC using a USB storage device Although the images 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 Note SonoSite supports the USB storage device included optionally with the system Other brands are untested and may not perform as expected WARNING To avoid damaging the USB storage device and losing patient data from it observe the following
90. ories 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 your body However if you experience symptoms such as constant or recurring discomfort pain throbbing aching tingling numbness burning sensation or stiffness promptly see a qualified health professional Such symptoms 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 activit
91. ort on page vii 3 Tap 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 Login as Administrator 2 Inthe User Login list select On e On requires a user name and password at startup e Off allows access to the system without a user name and password To change the administrator password or let users change passwords 1 Login as Administrator 2 Under User List select Administrator 3 Do any of the following e 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 11 e Let users change their passwords Select the Password changes check box 4 Tap Save User setup To add a new user 1 Login as Administrator 2 Tap New 10 Administration setup 3 Under User Information fill in the Name Password and Confirm boxes See Choosing a secure password on page 11 4 Optional In the User box type the user s initials to display them in the patient header and in the User box in the patient information form 5 Optional Select the Administration Access check box to allow access to all administration privileges 6 Tap Save To modify user information 1 Log in as Administrator 2 Under User List select the user 3 Under User Information make changes as desired
92. p this check box unselected unless you use SonoSite software products For more information see NanoMaxx System DICOM Conformance Statement Limitations of JPEG format When transferring or exporting images in JPEG format the system uses lossy compression Lossy compression may create images that have less absolute detail than BMP format and that don t render identically to the original images In some circumstances lossy compressed images may be inappropriate for clinical use For example if you use images in SonoCalc IMT software you should transfer or export them using BMP format SonoCalc IMT software uses a sophisticated algorithm to measure images and lossy compression may cause errors For more information on using lossy compressed images consult the industry literature including the following references Physics in Medicine and Biology Quality Assessment of DSA Ultrasound and CT Digital Images Compressed with the JPEG Protocol D Okkalides et al 1994 Phys Med Biol 39 1407 1421 doi 10 1088 0031 9155 39 9 008 www iop org EJ abstract 0031 9155 39 9 008 Canadian Association of Radiologists CAR Standards for Irreversible Compression in Digital Diagnostic Imaging within Radiology Approved June 2008 www car ca Files 5CLossy_Compression pdf Chapter 2 System Setup 15 dnjas 16 USB Devices setup Chapter 3 Imaging Imaging modes 2D controls Imaging modes available depend on the
93. perated 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 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 e 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 e Lower power from internal sources within facility control such as paging systems e Label devices susceptible to EMI e Educate clinical staff to recognize potential EMl related problems e 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 e Share relevant EMI information with others particularly when evaluating new equipment purchases which may generate EMI e Purchase medical devices that comply with IEC 606
94. r the OB table you intend to use See System defined OB calculations and table authors on page 29 WARNING To avoid incorrect OB calculations verify with a local clock and calendar that the system s date and time settings are correct before each use of the system The system does not automatically adjust for daylight savings time changes To avoid misdiagnosis or harming the patient outcome start a new patient information form before starting a new patient exam and performing calculations Starting a new patient information form clears the previous patient s data The previous patient s data will be combined with the current patient if the form is not first cleared See To create a new patient information form on page 20 System defined OB calculations and table authors The following table shows the system defined measurements available for OB calculations by author For definition of abbreviations see Glossary on page 81 To select authors see OB Calculations setup on page 13 If you change the calculation author during the exam the common measurements are retained Chapter 4 Measurements and Calculations 29 s UsWaiNseayy Ratios HC AC Campbell Calculation GestationalOB Table FL AC Hadlock Result Measurements Authors FL BPD Hohler Gestational GS Hansmann Age Nyberg FL HC Hadlock Tokyo U mp y Amniotic Q Q2 Q3 Q4 Jeng CRL Hadlock Fluid Index Hansmann Osaka a T
95. ransducer depth in situ LCD linear array transducer mechanical index MI MI TI NTSC PAL phased array 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 for example 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 C11n C60n 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 for example 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 L38n 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 de
96. rength 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 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 56 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
97. rker 5 output display 54 P PAL definition 81 password 10 11 patient header 5 13 patient information form 20 22 patient list 21 patient report about 31 general 31 pediatric intended uses 8 peripherals 79 pictographs place 20 power delay 12 precision acoustic measurement 70 preferences 13 presets 13 pressure limits 79 print 23 print control 2 printer problem 33 setup 12 probe See transducer R references gestational age tables 76 obstetrical 76 report patient 31 S safety battery 44 clinical 45 electrical 42 electromagnetic compatibility 46 equipment 44 save images 21 measurements 25 scanhead See transducer screen brightness 20 screen layout 5 security 9 setup pages 9 shipping specifications 79 SiteLink 14 skin line definition 82 sleep delay 12 software license 33 SonoHD technology 82 SonoMB technology 17 82 standards airborne equipment 80 electromechanical 80 EMC classification 80 HIPAA 80 storage alerts 13 storage specifications equipment 79 images 79 superficial intended uses 8 sweep speed M Mode 18 symbols labeling 71 system clean and disinfect 34 software 1 wake up 3 7 Technical Support vii temperature limits 79 text 6 19 thermal index TI 13 54 82 time setup 13 Tissue Harmonic Imaging 17 24 tissue models 57 touchscreen 5 25 35 transducer clean and disinfect 35 connect 3 curved array 81 definition 82 disinfect 35 exam type 24 general use 6 Inde
98. rmat and AE title see USB Devices setup on page 14 Exporting large amounts of data can take as long as a few hours depending on compression file type file size and number of files To avoid this issue export data frequently for example after each patient exam or at the end of each day To automatically export a patient exam If you want to hide patient information on images that you export manually export the exams 1 Make sure that Export to USB at end of exam is selected See To specify how patient exams export on page 14 2 Insert the USB storage device See Inserting and removing USB storage devices on page 4 3 End the exam To manually export patient exams A patient exam must be ended before you can manually export its images See To end the exam on page 21 Chapter 3 Imaging 23 1 Insert the USB storage device See Inserting and removing USB storage devices on page 4 2 Inthe patient list select the patient exams you want to export and then tap Exp USB 3 If prompted select the USB storage device If you want to hide patient information deselect Include patient information on images Only available USB devices are selectable Note You can avoid prompts to select the USB storage device See To specify how patient exams export on page 14 4 Tap Export The files finish exporting approximately five seconds after the USB animation stops Removing the U
99. romagnetic 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 interference 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 47 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 gt 95 dip in U for 0 5 cycle 40 U7 60 dip in U7 for 5 cycles 70 Ur 30 dip in U7 for 25 cycles gt 5 Ur gt 95
100. rs All predefined label groups for all exams are replaced with those from the USB storage device Audio Battery setup On the Audio Battery setup page you can select options from the following lists Key click Select On or Off for controls to make a clicking sound when tapped Beep alert Select On or Off for the system to beep when saving warning starting or shutting down Sleep delay Select Off or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode Power delay Select 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 system for a printer 1 Set up the printer hardware See instructions included with the stand or printer 2 On the Connectivity setup page select the printer in the Printer list 3 Select the video mode for your region NTSC or PAL 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 e Inthe Date box type the current date See Entering text on page 6 e Inthe Time box type the current time i
101. se to move the line up Adventitia Tap Touch screen and then drag the line with your finger Press the knob to return to the previously displayed controls Hide Use to check results Tap to hide the Show measurement results and trace line Tap again to redisplay them 4 gt Adjusts the tool width Turn the knob clockwise to increase the Width width or counter clockwise to decrease it Smooth Adjusts the IMT line smoothing When Smooth is set to On s appears after the measurement result at the bottom of the screen To measure plaque 1 Ona frozen 2D image tap Calcs 2 Tap Right or Left for the side measured 3 Tap Plaque and select Plaq 1 or Plaq 2 A set of calipers appears 4 Position the calipers as desired See Working with calipers on page 25 5 Ifyou want to save the measurement tap Save The measurement saves to the patient report and the image with the measurement displayed saves to internal storage 6 Exit the measurement by tapping one of the following e Unfreeze to return to live imaging e Clear Calc to clear the measurement from the screen allowing additional measurements on the image OB calculations EFW is calculated only after you complete the appropriate measurements If any one of these parameters results in an EDD greater than what the OB tables provide the EFW is not displayed WARNING Make sure that you have selected the OB exam type and the OB calculations author fo
102. select a sort order from the Sort By list The sort order specifies how exported files are organized To return to the previous screen tap Devices To specify how patient exams export If you want to hide patient information on images that you export manually export the patient exams See To manually export patient exams on page 23 Select one of the following e Export to USB at end of exam The exam automatically exports to a USB storage 14 USB Devices setup device when ended If multiple or no USB storage devices are present the system prompts you to select one e Quick export to USB When manually exporting from the patient list the system prompts you to select a USB storage device only if one is not present If you want to hide patient information on images that you export deselect this option See also To insert a USB storage device on page 4 and Exporting to a USB storage device on page 23 To specify AE title The AE title identifies your system with exported images that you import to a PACS archiver On the USB Devices setup page type a unique name for your system in the AE Title text box Default is NanoMAXX To include private tags If you use DICOM export type and a SonoSite software product include private tags on the images On the USB Devices setup page select Include private tags Note Because the tags may be incompatible with some earlier archivers kee
103. setup 12 Date and Time setup 13 Display Information setup 13 OB Calculations setup 13 Presets setUp scissscssssssssssececsccsesnsscscescctdbcecscssadsnsstansssbicsz vaiiedseeapasrtediiveesiiastasptinsaniatiede 13 System Information setup sssssssessssssssssecesessssssecesssssseeecssssssseeerassssssoceressssssseeresssssee 13 USB IDG VICES SOUP a csscasccce sctscsesscide5s2iddsssebecansecasseaiccdcctusdeats chaste A 14 Limitations Of JPEG format cccssesssssssssssesssssessessessessessessssseessssessssssssssssesssees 14 Chapter 3 Imaging Imaging modes 2D imaging 17 DOCG rinrita iieiea AE EEE EE EAEE 17 CPD and color Doppler imaging sssssssssssssssssessssssssssseessereserssesssssssssssesssessssses 18 Adjusting depth and gain sssssssssssssssssssssssessssesssssssssssessseessesseeerereeresnesssnssnnsnsssssessseese 18 Freezing viewing frames and ZOOMING ssescssesscsseecssseccssesesssesccsseeesseecnseeeesee 19 Turning guidelines on and off ssescccssssseessesscecssssecesssesccesnseceseaseecessseecesessseeseeees 19 ANMOtAatiNG IMAGES sesscssesosessssssssesasssssenenoscasssssessasacssesrassssssssosessesonsgsnbssouedbiacosasssoesnvsson 19 Adjusting screen brightness sssssssssssecssscsssecssesssecssccssscenscssscsssceeseeesacersceesesseees 20 Patient information fOrm ssssssscsssesssesssecccssescccsssessessseceessseccessnsessssneecsssseeeeesssees 20 REVIEWING patient
104. signed primarily for cardiac scanning Forms a sector image by electronically steering the beam direction and focus Glossary 81 Aiessoj5 82 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
105. sity Ultrasound in Obstetrics and Gynecology July 20 1990 101 102 University of Tokyo Shinozuka N FJSUM et al Standard Values of Ultrasonographic Fetal Biometry Japanese Journal of Medical Ultrasonics 23 12 1996 886 Gestational Sac GS Hansmann M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1985 Chapter 7 References 77 saouaiajay Nyberg D A et al Transvaginal Ultrasound Mosby Yearbook 1992 76 Gestational sac measurements provide a fetal age based on the mean of one two or three distance measurements however Nyberg s gestational age equation requires all three distance measurements for an accurate estimate Tokyo University Gestational Weeks and Computation Methods Ultrasound Imaging Diagnostics 12 1 1982 1 Head Circumference HC Chitty L S and D G Altman New charts for ultrasound dating of pregnancy Ultrasound in Obstetrics and Gynecology 10 1997 174 191 Table 5 182 Hadlock F et al Estimating Fetal Age Computer Assisted Analysis of Multiple Fetal Growth Parameters Radiology 152 1984 497 501 Hansmann M et al Ultrasound Diagnosis in Obstetrics and Gynecology New York Springer Verlag 1985 431 Humerus Length HL Jeanty P F Rodesch D Delbeke J E Dumont Estimate of Gestational Age from Measurements of Fetal Long Bones Journal of Ultrasound in Medic
106. sscosecsecseccsccnsessscnsecssecssensessseasesseensesseenecssceneenscsseessess 75 Sources of measurement ELLOS eeesssessssessssssssscssccssccsscsssssesecessccsseesstecseecsueceseeeseeess 75 Measurement publications a75 IMT references OB references use 76 Gestational age tables oc sesssssscsssesssecssecssscsseecseesssccsnscesecesscssesesssecseesacessees 76 Chapter 8 Specifications Supported transducers 79 Imaging modes 79 Image storage Accessories 79 PENA Meal sccsececasscsccssssavsssdezeesassdocncwsa cessde excess a a aR 79 Envir nmental IMIS sssini adaise 79 Operating feereener eters rier eerie fe tree rent erences fe teeter errr Ea 79 SHIPPING ANC Storage 0 sessssesscssescssscccssesecsseccsnscesssccessecsnscsenseeesnecsenneeesseeeesaes 79 Electrical sccsscsscasacsavavasscessssanseccunsssavssscootatusintosanssavasicdava ausvatessatassassooustussstuesseitoastcasiaatans 80 Battery einan osnsasccseceatssavacesovenssncaucouassusvecuesvassscueposasoustens 80 Electromechanical safety standards ou sssssssssscsssescsstecssseccnseeessecesseeecsseseseseeese 80 EMC standards classification ssesscsssssssscsssescesssessssssseecessssecsesnecssenseeeeesneessenseeses 80 Airborne equipment Standards ccssccssscssscssecssessecssssssscsssccsscssscseseeesscesecesseees 80 HIPAA Stam andl sicscsssccssesesusssssescelcowscdtsccossssssescovanscstdsccovssansssazscssstvesctvssstassiestinsas
107. ssssssssssrssssesresseoresssersssseensse 34 Cleaning and disinfecting the ultrasound system 1 34 Cleaning and disinfecting transducers sssscssesscssssecssescssescsseceseeesensees 35 Cleaning and disinfecting the battery or COCK uu eessessessesessesenseeeeneeees 37 Chapter 6 Safety EFGOMONMIG tc ir a A A E EEEE 39 Position the System ceccsssscssecssesssessssecssccssecesseessccssecesscessecsssssaceesseesneceaseesseess 40 Position yourself sssini annn 40 Take breaks exercise and vary activities ssssssssssssssssssssssssessssesessreessrse 41 Electrical safety classification c sssssssssssssssccsssessssessssescssssccsssccssssccssesessssecssnessseeees 41 Electrical Safety simonsii ir ia E A EEREN 42 Equipment safety osicscccssssscicsschesidasccoccasddencssicesauasscansssubdecasulelcavecentassuceccadevesdessbuetsotieled 44 Battery Safety ccscsssssessseccassacessasesssnssteosdaseussvonssesestescwsenserostelassonsseneuaaashesntenenthsaucetiniee 44 Clinical safety 45 Hazardous materials a Electromagnetic compatibility Manufacturer s declaration ALARA principle sses 50 Ap yitig ALARA saiscscacccsssvesesssessedvescscsciSessanstesiduseacacsasvessssseascbctesstessteseestbascsanercce 51 Direct COMEMOIS sscssscessssssssvacnssssenscoesssssenssssnsuseasasnsssvesstensnnassacaeostonsenivacsnoeasnaaaqensuste 51 Indirect Controls scccisesssssvaznasssesacoesssesenssssnasessaseniav
108. st Edition Underwriters Laboratories Medical Electrical Equipment Part 1 General Requirements for Safety EMC standards classification EN 60601 1 2 2007 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 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 Glossary Terms For ultrasound terms not included in this glossary refer to Recommended Ultrasound Terminology Third Edition published by the American Institute of Ultrasound in Medicine AIUM as low as reasonably The guiding principle of ultrasound use which states that you should achievable ALARA curved array t
109. t not be removed or defeated 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 Do not touch any of the following The ungrounded signal input output connectors on the NanoMaxx dock The system battery contacts inside the battery compartment Do not connect the system s power supply or the stand s auxillary mains outlet receptables to an MPSO or extension cord Before using the transducer inspect the transducer face housing and cable Do not use the transducer if the transducer or cable is damaged e Always disconnect the power supply from the system before cleaning the system Caution Do not use any transducer that has been immersed beyond the specified cleaning or disinfection level See Chapter 5 Troubleshooting and Maintenance e 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 recommended by SonoSite Use commercial grade peripherals recommended by SonoSite on battery power only Do not connect these products to AC mains power when using the system to scan or diagnose a patient subject Contact SonoSite or yo
110. tap Switch A B To place calipers more precisely Do any of the following e Use the knob instead of the touchscreen e Adjust the display for maximum sharpness e Use leading edges closest to the transducer or borders for starting and stopping points e Maintain a consistent transducer orientation for each type of measurement e Make sure that the area of interest fills as much of the screen as possible e Minimize the depth or zoom e Calibrate the touchscreen See To calibrate the touchscreen on page 13 Measuring To take a measurement in 2D Distance is measured in centimeters 26 Measurements 1 Ona frozen image tap oa Calipers A set of calipers appears connected by a dotted line and labelled A 2 Position the first caliper where desired See To position calipers on page 25 3 Tap Select The second caliper becomes active 4 Position the second caliper where desired 5 If you want an additional set of calipers tap Caliper A set of calipers labelled B appears Position the calipers where desired 6 Optional Tap Save The image saves with the measurements displayed To take a distance measurement in M Mode Distance is measured in cm Time is measured in seconds The time scale above the trace has small marks at 200 ms intervals and large marks at one second intervals 1 Ona frozen M Mode trace tap Calipers A single caliper appears 2 Position the caliper
111. tly 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 Rinse with water or wipe with water dampened cloth and then wipe with a dry cloth Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration Wipe surfaces with the disinfectant solution Air dry or towel dry with a clean cloth 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 To clean and disinfect a transducer immersion method 1 2 3 Disconnect the transducer from the system Remove any transducer sheath 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 Rinse with water or a wipe with water dampened cloth and then wipe with a dry cloth Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration Immerse the transducer into the disinfection solution not more than 12 18 inches 31 46 cm from the point where the c
112. tomer 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 For technical support please contact SonoSite as follows SonoSite Technical Support Phone 877 657 8118 US or Canada Phone 425 951 1330 Outside US and Or call your local Canada representative Fax 425 951 6700 E mail service sonosite com Web site www sonosite com Click Resources gt Support amp Service Europe Service Center Phone 44 0 1462 444 800 E mail uk service sonosite com vii uo1 9Npo 3u viii Customer comments Chapter 1 Getting Started About the system The NanoMaxx ultrasound system is a portable software controlled device that acquires and displays high resolution real time ultrasound images Features available on your system depend on the configuration transducer and exam type You need a license key to activate the software See Software licensing on page 33 Basic steps 1 Turn the system on 2 Attach a transducer 3 Tap Patient and complete the patient information form 4 Tap Mode and select an imaging mode By default the system is in 2D imaging
113. um index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 64 Table 13 Transducer Model P21n 5 1 Operating Mode 2D TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 4 a 2 1 Pr3 MPa 1 974 Wo mW 158 3 min of W 3 z1 lTa 3 Z1 mW E Z1 cm ora g z Zbp cm gE Zsp cm SS 2 Pllamax 3 6 2 Mag cm fe MHz 1 94 1 90 Dim of Aaprt X cm 0 59 Y cm 1 3 PD usec 0 924 S PRF Hz 5556 8 P Pllmax MPa 2 39 amp deq Pllmax cm s Focal Length FL cm E 1 55 E FLy cm 5 5 Ipa 3 Mlmax W cm 180 5 E Control 1 Exam Type Abd Abd 5 Control 2 2D Optimization es Res Gen 2s Control 3 Depth 7 5 cm 4 7 cm S S Control 4 THI On On S Control 5 MB Multi Beam Off On 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 65 Ayayes Table
114. ur local representative for a list of the commercial grade peripherals available from or recommended by SonoSite To avoid the risk of electrical shock and fire hazard inspect the power supply AC power cords cables and plugs on a regular basis Ensure that they are not damaged To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high voltage 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 t
115. wn Left D R Down Right or U R Up Right To remove the pictograph tap Hide Tap Show to display it again 20 Adjusting screen brightness To return to the previous screen tap Back Adjusting screen brightness The screen brightness affects battery life To conserve battery life adjust brightness to a lower setting To adjust the screen brightness In 2D imaging tap ie and then turn the knob Patient information form WARNING To avoid misdiagnosis caused by confusing the images from multiple patients make sure to enter patient ID patient name or both in the patient information form The patient information form lets you enter patient identification exam and clinical information for the patient exam This information automatically appears in the patient report When you create a new patient information form all images and other data you save during the exam are linked to that patient See Patient report on page 31 To create a new patient information form Note Creating a new patient information form erases any unsaved patient information including calculations and report page To save this information save the screen for each item 1 Tap Patient 2 Tap New End 3 Fill in the form fields See Patient information form fields on page 21 and Entering text on page 6 4 Tap Done See also To append images to a patient exam on page 22 To edit a patient information
116. x 87 x pul imaging modes 24 invasive or surgical use 7 linear array 81 preparation 6 problems 33 sheath 7 troubleshoot 33 U ultrasound terminology 81 USB export 14 23 insert or remove device 4 user accounts 10 user guide conventions used vii user setup 10 uses intended 7 V vascular intended uses 8 WwW warnings definition vii Z zoom 19 88 Index BSonoSite P12529 03 ACA AA N
117. yroid testicle lymph nodes hernias musculoskeletal structures soft tissue structures and surrounding anatomical structures for the presence or absence of pathology You can use the system to provide ultrasound guidance for biopsy and drainage procedures vascular line placement peripheral nerve blocks and spinal nerve blocks and taps Vascular Imaging Applications You can assess the 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 for the presence or absence of pathology 8 Intended uses 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 Tap Options and select Setup 2 Do any of the following e Select the setup page from the Page list e Tap Previous or Next until the page appears e With the Page list highlighted press the knob Turn the knob to highlight the page and then press the knob To return to imaging from a setup page tap Done Restoring default settings To restore default settings for a setup page On the setup page tap 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 3 3 While pressing down the knob press and release the power switch Release the knob after two beeps The s
118. ystem beeps several times 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 display the Event log Security settings WARNING Health care providers who maintain or transmit health 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 On the Administration setup page type Administrator in the Name box See Entering text on page 6 Chapter 2 System Setup 9 dnjas 2 Type the administrator password in the Password box If you need the administrator password contact SonoSite See SonoSite Technical Supp

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