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Chapter 5:  Safety

Sa

fe

ty

Superficial Imaging Applications:

This system transmits ultrasound energy into various parts of the body using 2D and CPD to obtain 
ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, 
soft tissue structures, and surrounding anatomical structures can be assessed for the presence or 
absence of pathology. This system can be used to provide ultrasound guidance for biopsy and 
drainage procedures, vascular line placement, and peripheral nerve blocks.

Vascular Imaging Applications:

This system transmits ultrasound energy into the various parts of the body using 2D and CPD to 
obtain ultrasound images. The carotid arteries, deep veins in the arms and legs, superficial veins in 
the arms and legs, great vessels in the abdomen, and various small vessels feeding organs can be 
assessed for the presence or absence of pathology.

About the Acoustic Output Table

The terms used in the acoustic output tables follow:
Transducer Model is the SonoSite transducer model.

Warning:

This system is not intended for use in providing guidance for central nerve blocks, 
i.e., the brain and spinal cord, or for ophthalmic applications.

Table 1: Acoustic Output Terms and Definitions

Term

Definition

I

SPTA

.3

Derated spatial peak, temporal average intensity in milliWatts/cm

2

.

TI type

Applicable thermal index for the transducer, imaging mode, and exam type.

TI value

Thermal index value for the transducer, imaging mode, and exam type.

MI

Mechanical index.

I

pa.3

@MImax

 

Derated pulse average intensity at the maximum MI in units of W/cm

2

.

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.

Summary of Contents for iLook

Page 1: ...iLook USER GUIDE...

Page 2: ......

Page 3: ...iLook USER GUIDE...

Page 4: ...5207225 5215094 5226420 5226422 5233994 5255682 5275167 5287753 5305756 5353354 5365929 5381795 5386830 5390674 5402793 5 423 220 5438994 5450851 5456257 5471989 5471990 5474073 5476097 5479930 54820...

Page 5: ...tion the System 8 Position Yourself 9 Go Lightly 9 Take Breaks 9 Exercise 10 System Controls 10 Screen Layout and Icons 11 General Operation 13 Directional Controller 13 Touch Screen 14 On Screen Keyb...

Page 6: ...Output Measurement 47 In Situ Derated and Water Value Intensities 47 Tissue Models and Equipment Survey 48 Intended Uses 49 About the Acoustic Output Table 50 Acoustic Output Tables 52 Global Maximum...

Page 7: ...ting Limits System Docking Station Stand 75 Shipping Storage Limits System Docking Station without Battery 75 Operating Limits Battery 75 Shipping Storage Limits Battery 75 Electrical 76 Battery 76 El...

Page 8: ...vi...

Page 9: ...ded here Chapter 2 Getting Started Contains information on healthy scanning practices basic operation and changing system settings Chapter 3 The Exam Contains detailed information about preparing for...

Page 10: ...call SonoSite at 1 888 482 9449 If you are outside the USA call the nearest SonoSite representative You can also send electronic mail e mail to SonoSite at the following address comments sonosite com...

Page 11: ...connector Stylus Table 1 The iLook System Item Description Battery Two batteries are provided Fully depleted batteries require approximately two hours to charge to 90 capacity and three hours to char...

Page 12: ...battery life the system has an automatic shut off feature When powered on and no buttons have been pressed for 5 minutes the system will automatically turn off If desired this feature can be disabled...

Page 13: ...To charge the battery in the system Insert the system in the docking station or stand for iLook See To charge the system battery on page 37 Or Connect the auxiliary power cable and power supply See T...

Page 14: ...are available no pad the small handle pad or the large handle pad The small handle pad is installed and is suitable for most hand sizes SonoSite recommends using the large handle pad if your hands ar...

Page 15: ...e 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 phy...

Page 16: ...for the handle opening size to be customized To minimize eye strain consider the following When the exam procedure allows position the system within reach Adjust the angle of the system display to min...

Page 17: ...ur scanning arm consider the following Keep your elbow close to your side Relax your shoulders in a level position Support your arm using a support cushion or pillow or rest it on the bed To minimize...

Page 18: ...moving Avoid sustaining the same posture by varying your head neck body arm and leg positions Exercise Targeted exercises can strengthen muscle groups which may help you avoid MSDs Contact a qualified...

Page 19: ...Patient Information Exam Type Image Review and System Set up Press again to return to imaging Directional Controller Use to navigate on screen menus adjust caliper position and enter data Use the rig...

Page 20: ...lays exam type Transducer Displays the type of transducer C15 or L25 permanently attached to the system Harmonic icon C15 only Displayed when tissue harmonic imaging is on Freeze image icon Displayed...

Page 21: ...d in the User Guide to describe the directional controller actions Orientation marker Indicates image orientation relative to transducer Skin line The location where the transducer is placed Guideline...

Page 22: ...h screen action Note If the touch screen alignment is off calibrate the touch screen See To calibrate the touch screen on page 18 On Screen Keyboard The on screen keyboard is used for alphanumeric dat...

Page 23: ...Select or tap the right and left arrows to move the cursor to the right or left in the data field Back slash Select or tap back slash in the name ID field to separate the patient name and ID number Sp...

Page 24: ...e menu to adjust the display contrast 2 Use the right and left arrows or tap the touch screen to choose the desired setting 0 10 Audio 1 Highlight or tap Audio from the menu to change audio feedback 2...

Page 25: ...tap Previous Page from the menu to view the first page of the Set up menu Language 1 Select or tap Language from the menu to change the system language 2 Select or tap the desired language Note The sy...

Page 26: ...menu 5 Select or tap Calibration from the on screen menu A confirmation dialog appears 6 Select Yes to proceed or select No to cancel 7 Tap the center of each cursor that appears Note If the cursor i...

Page 27: ...stem Set up from the on screen menu 3 Select or tap Next Page from the on screen menu 4 Select or tap System Info from the on screen menu The system information screen displays the following informati...

Page 28: ...20 Chapter 2 Getting Started Getting Started...

Page 29: ...transducer sheaths for clinical applications of an invasive nature 1 Place gel inside the sheath 2 Insert the transducer into the sheath Warning Verify that the patient information date and time sett...

Page 30: ...tient name ID 1 Press the Patient key 2 Select or tap Patient Information from the on screen menu A cursor appears in the Name ID field for entering text 3 Select or tap the on screen keyboard to ente...

Page 31: ...ging Depth 1 Highlight Depth from the on screen menu 2 Arrow right to increase depth and left to decrease depth Note The number in the lower right corner indicates the depth in centimeters Gain 1 High...

Page 32: ...1 Highlight L R from the on screen menu 2 Arrow right or left to flip image orientation Harmonics H C15 only Select H from the on screen menu to turn on Tissue Harmonic Imaging Select H again to turn...

Page 33: ...ain settings If the vessel fails to fill with color after continually increasing the CPD gain try slowly decreasing the gain To optimize CPD or DCPD Move 1 The region of interest ROI box is highlighte...

Page 34: ...ack Cine 1 Use the right and left arrows or tap Fwd and Back from the on screen menu to view the frozen image at different points in time 2 Press the Freeze key again to return to live imaging Measure...

Page 35: ...hlighted green 2 Position the first caliper by tapping the touch screen on the desired location Use the right left up or down arrows on the directional controller to make fine adjustments The measurem...

Page 36: ...e right left up or down arrows to reposition 8 Select Done from the on screen menu to remove the measurement menu The measurement and calipers are removed from the screen 9 Press the Freeze key to ret...

Page 37: ...rd set of calipers is displayed on the screen 7 Perform the third distance measurement to complete the volume calculation The measurement and volume results are displayed in the upper left section of...

Page 38: ...images Next 1 Highlight Next from the on screen menu 2 Arrow right or tap on Next to advance to the next image stored in the system memory Previous 1 Highlight Prev from the on screen menu 2 Arrow le...

Page 39: ...lete all the saved images or No to cancel 4 Select or tap Exit from the on screen menu or press the Patient key to return to live imaging After the Exam Check the battery after each use to ensure adeq...

Page 40: ...32 Chapter 3 The Exam Exam...

Page 41: ...system when it is not in use The docking station charges the battery in the system and an extra battery The docking station provides connections for the power supply an RS 232 cable for downloading i...

Page 42: ...e system The stand also provides connections for the power supply an RS 232 cable for downloading images to a personal computer PC and a video cable for connecting a printer Note The USB and print con...

Page 43: ...the stand 1 Release the locking lever 2 Carefully remove the system by lifting it out of the sleeve 3 Remove the transducer To adjust the viewing angle 1 Hold the bottom of the sleeve with one hand an...

Page 44: ...station or stand 2 Connect the AC power cord to the iLook power supply and connect the power cord to a hospital grade outlet 5 3 4 2 1 6 5 3 4 2 1 Docking station Stand Table 1 Docking Station and St...

Page 45: ...tation show the charging status of the system battery Amber indicates the battery is charging and green indicates a fully charged battery See Figure 1 on page 33 Note If the indicator lights do not co...

Page 46: ...3 Connect the power supply to the auxiliary power cable and connect the power supply to AC power cord Note To check the battery charge disconnect the cable power on the system and check the battery c...

Page 47: ...to an immovable object The iLook system has a Kensington Security Slot located on the back of the system Figure 5 Kensington Security Slot To attach a Kensington Security Cable 1 Wrap the cable aroun...

Page 48: ...ting the null modem serial cable from the RS 232 connector on the docking station or stand to the RS 232 on the host personal computer PC For more information please refer to the SiteLink Image Manage...

Page 49: ...See Chapter 7 Specifications For maximum safety observe the following warnings and cautions Warning To prevent musculoskeletal disorders follow the Healthy Scanning Guidelines found in Chapter 2 of t...

Page 50: ...ontacts while simultaneously touching a patient subject To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high voltage defibri...

Page 51: ...move the battery from the system if the system is not likely to be used for some time Do not spill liquid on the system Warning The battery has a safety device Do not disassemble or alter the battery...

Page 52: ...ge 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...

Page 53: ...ed 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 Dopple...

Page 54: ...improve image quality before using controls that directly or indirectly affect output Output Display The system meets the AIUM output display standard for MI and TI see last reference listed in Relat...

Page 55: ...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...

Page 56: ...m and consists largely of fluid When this model is used to estimate maximum exposure to the fetus during transabdominal scans a value of 1 dB cm MHz may be used during all trimesters Existing tissue m...

Page 57: ...assessed for the presence or absence of obvious pathology Interventional and Intraoperative Imaging Applications This system transmits ultrasound energy into the various parts of the body using 2D CPD...

Page 58: ...s the SonoSite transducer model Warning This system is not intended for use in providing guidance for central nerve blocks i e the brain and spinal cord or for ophthalmic applications Table 1 Acoustic...

Page 59: ...sp zb 3 in centimeters deq z Equivalent beam diameter as a function of axial distance z and is equal to where ITA z is the temporal average intensity as a function of z in centimeters fc Center freque...

Page 60: ...ts of Appendix G Section C2 of the September 30 1997 issue of the FDA document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Table 2 Acoust...

Page 61: ...f 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 Labeling Symbol...

Page 62: ...es labeling Canadian Standards Agency REF Catalog number H E 01 H marking indicating compliance with Annex II of EuM Decree 47 1999 X 6 by the Institute for Hospital and Medical Engineering of Hungary...

Page 63: ...r 5 Safety 55 Safety Do not stack over 5 high Do not stack over 10 high Paper Recycle Submersible Protected against the effects of temporary immersion Electrostatic sensitive devices Symbol Definition...

Page 64: ...56 Chapter 5 Safety Safety...

Page 65: ...e or call 425 951 1330 Technical support fax 1 425 951 6700 Technical support e mail service sonosite com SonoSite website www sonosite com and select Technical Support under Special Features Table 1...

Page 66: ...tenance required for the iLook system transducer or accessories There are no internal adjustments or alignments that require periodic testing or calibration All maintenance requirements are described...

Page 67: ...vel of disinfection required for a device is dictated by the type of tissue it will contact during use Ensure the disinfectant type is appropriate for the type of transducer and application For inform...

Page 68: ...solution expiration date and ensure that the date has not passed To avoid infection the level of disinfection required for a product is dictated by the type of tissue it contacts during use Ensure the...

Page 69: ...y always use protective eyewear and gloves when performing cleaning and disinfecting procedures To avoid infection if a pre mixed disinfection solution is used observe the solution expiration date and...

Page 70: ...e 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 3 Rinse wit...

Page 71: ...ipe surfaces with the disinfectant solution 6 Air dry or towel dry with a clean cloth 7 Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discont...

Page 72: ...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 Docking Station and Stan...

Page 73: ...ean 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 solu...

Page 74: ...eraldehyde N N N Autoclave Steam System Steam Heat N N N Bacillocid rasant Germany Liquid Glut Quat Ammonia T C U A Bacillol 25 Germany Liquid Ethanol Propanol U U U Bacillol Plus 3 Germany Spray Prop...

Page 75: ...por Spray USA Spray Gluteraldehyde U U U Control III 4 USA Liquid Quat Ammonia T C T C A Coverage Spray 4 USA Spray Quat Ammonia T C T C A Cutasept F Germany Spray 2 Propanol U U U Dialdehyde 4 USA Li...

Page 76: ...ldehyde Propanol U U U Hi Tor Plus 4 USA Liquid Chloride T C T C A Hibiclens USA Cleaner Chlorhexidine T C T C A Hydrogen peroxide USA Liquid Hydrogen Peroxide U U A Incides Germany Wipe Alcohol U U U...

Page 77: ...raldehyde T C T C A Metriguard 4 USA Liquid Ammonium Chloride U U U MetriSpray 3 4 USA Spray Gluteraldehyde U U U MetriZyme USA Cleaner Propylene Glycol T C T C A Mikrobac forte 3 Germany Liquid Ammon...

Page 78: ...quid Quat Ammonia U U U Precise 4 USA Spray O phenylphenol T C T C A Presept USA Liquid NaCl Dichlorite U U U Presept Canada Liquid Gluteraldehyde U U U ProCide 4 USA Liquid Gluteraldehyde U U U ProCi...

Page 79: ...U Sekusept Plus Germany Liquid Glucoprotamin U U U Sekusept Pulver Germany Liquid Natriumperborat U U U Sklar 4 USA Liquid Isopropanol T C N N Sporadyne France Liquid Didecyldimethyl U U U Sporicidin...

Page 80: ...Virex 4 USA Liquid Quat Ammonia U U U Wavicide 01 2 4 5 USA Liquid Gluteraldehyde T C T C A Wavicide 06 4 USA Liquid Gluteraldehyde N N N Wex Cide 4 USA Liquid O phenylphenol T C T C A 1 Compatible b...

Page 81: ...ucer and battery installed Weight 2 8 lbs 1 27 kg with the L25 transducer and battery installed Display Dimensions Length 3 25 in 8 26 cm Width 4 25 in 10 8 cm Diagonal 5 25 in 13 34 cm Transducers C1...

Page 82: ...ries Hardware Software and Documentation AIUM Ultrasound Medical Safety Guidance Document Battery Docking station Handle pads Power supply Printer bracket Quick Reference Guide SiteLink Image Manager...

Page 83: ...curity Cable Temperature Pressure and Humidity Limits Note The temperature pressure and humidity limits apply only to the ultrasound system and transducers Operating Limits System Docking Station Stan...

Page 84: ...Equipment General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests C22 2 No 601 1 1990 Canadian Standards Association Medical Electrical Equipment Part...

Page 85: ...ain a consistent transducer orientation for each type of measurement When the calipers are positioned farther apart they get larger When the calipers are moved closer together they get smaller The cal...

Page 86: ...tion error includes errors introduced by the ultrasound system electronics relating to signal acquisition signal conversion and signal processing for display Additionally computational and display err...

Page 87: ...eferences Terminology and Measurement Publications Terminology and measurements comply with AIUM published standards Reference Volume Vol Beyer W H Standard Mathematical Tables 28th Edition CRC Press...

Page 88: ...80 Chapter 8 References References...

Page 89: ...it for ultrasound terms not contained in this glossary Keys Terms Freeze key which stops live imaging and displays the frozen image with cine buffer Menu key which turns the live imaging menu on and o...

Page 90: ...splay curved array transducer C15 4 2 Identified by the letter C curved or curvilinear and a number 15 The number corresponds to the radius of curvature of the array expressed in millimeters The trans...

Page 91: ...deeper echoes See also Gain and Near freeze A system control used to stop image acquisition Also allows you to view the current image and use the cine arrow keys to view a cine series Forward Fwd A me...

Page 92: ...of the acoustic beam mechanical index MI An indication of the likelihood of mechanical bioeffects occurring the higher the MI the greater the likelihood of mechanical bioeffects See Chapter 5 Safety f...

Page 93: ...ription of TI Tissue Harmonic Imaging C15 only Transmits at one frequency and receives at a higher harmonic frequency to reduce noise and clutter and improve resolution touch screen The display works...

Page 94: ...86 Chapter 9 Glossary Glossary...

Page 95: ...on 3 remove 5 safety 43 specification 75 76 storage and shipping 75 battery icon description 12 biological safety 44 B mode See 2D image brightness adjust 16 definition 82 C cable auxiliary power 38 c...

Page 96: ...ng system 60 transducer cables 63 transducers 61 display definition 83 output 46 specifications 73 docking station about 33 connectivity 36 definition 83 done select 17 18 Doppler amplitude mode defin...

Page 97: ...e storage icon 12 specifications 74 in situ definition 83 intended uses 49 intensity derated 47 in situ 47 water value 47 interventional intended uses 49 intraoperative intended uses 49 IrfanView soft...

Page 98: ...t 29 probe See transducer R review image 30 S safety battery 43 biological 44 disinfectants 59 electrical 41 equipment 43 ergonomic 7 save description 11 images 29 scanhead See transducer screen areas...

Page 99: ...ust page 2 17 audio 16 auto shut off 16 brightness 16 contrast 16 date time 18 definition 85 done 17 18 language 17 system info 18 video format 17 T temperature limits 75 thermal index TI definition 8...

Page 100: ...92 Index Index...

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