InnoSight Diagnostic Ultrasound System User Manual
InnoSight Ultrasound System Contents Chapter 1 Read This First ................................................................................................ 1 Intended Audience ............................................................................................................................................ 1 Intended Use ..................................................................................................................................................... 1 Warnings ..............
InnoSight Ultrasound System TI ............................................................................................................................................................... 25 MI .............................................................................................................................................................. 25 Display and Report in Different Modes .....................................................................................................
InnoSight Ultrasound System Turning On/Off the System ............................................................................................................................. 51 Logging Into the System .................................................................................................................................. 51 Creating a New Administrator Account .................................................................................................... 52 Adding a New User Account....
InnoSight Ultrasound System Freezing an Image ........................................................................................................................................... 76 Adding Annotations......................................................................................................................................... 76 Arrow ........................................................................................................................................................
InnoSight Ultrasound System Adjusting the Color Priority ....................................................................................................................... 93 Inverting the Color Display ........................................................................................................................ 94 Using Directional Power ............................................................................................................................ 94 M-Mode Image Controls .....
InnoSight Ultrasound System Chapter 9 Transducers .................................................................................................107 Transducer Maintenance .............................................................................................................................. 107 Acoustic artifacts ........................................................................................................................................... 107 Transducer Covers .........................
1 1 Read This First The InnoSight Diagnostic Ultrasound System (hereinafter called system ) is an easy-to-use, portable ultrasound imaging instrument intended for use by a qualified operator for ultrasound evaluation and clinical analysis The User Manual provides important procedures and information on how to operate the system and service the system correctly and safely Before attempting to operate the system, read this manual and strictly observe all warnings and cautions Pay extra attention to the inf
InnoSight Ultrasound System Do not use the system for purposes other than those intended and expressly stated above Do not misuse the system, and do not use or operate the system incorrectly Installation, use, and operation of the system are subject to the law in the jurisdictions in which it is used Install, use, and operate the system only in such ways that do not conflict with applicable laws or regulations, which have the force of law Use of the system for purposes other than those intended and express
InnoSight Ultrasound System Supplies and Accessories To order transducer covers and other supplies and accessories, contact CIVCO Medical Solutions: CIVCO Medical Solutions 1 2 First Street South, alona, IA 224 9 Telephone: Fax: 9 44 6 41 (USA and Canada), 1 319 24 6 (International) 329 24 2 (USA and Canada), 1 319 24 666 (International) E-mail: info civco com Internet: www civco com To order the items listed in the following table, see the referenced information and contact your Philips representativ
InnoSight Ultrasound System Passing Your System to Another User If you pass this system to another user who will use the system for its intended purpose, then pass it on in its complete state Particularly, ensure that all the product-support documentation, including all instructions for use, are passed on to the new user Make the new user aware of the support services that Philips provides for installing, commissioning, and maintaining the system, and for comprehensive operator training Existing users must
InnoSight Ultrasound System If electrolyte leakage occurs, wash your skin with large amounts of water to prevent skin irritation and inflammation Equipment List Check the sales package for the following items If any item is missing or damaged, contact your place of purchase immediately Philips Ultrasound System Medical grade AC/DC power adapter Quick Install Guide Operating Notes Philips System S/N Reference Card User Manual (this document) AC plugs One or more Philips Transducers Two USB flash drives con
InnoSight Ultrasound System Product Conventions The system uses certain conventions throughout the interface to make it easy for you to learn and use: Refer to the following table to control the system using gestures (See page ) Touch Touch and Hold Drag Double-Tap Press and Tap Two-Finger Tap Pinch Spread x2 Flick To adjust the parameter value of a function, touch the plus/minus buttons (+/-) 12/5/2016 08:56 AM Menu Abdomen 2D Color M CPA PW 1 2D Gen Gn 43 DR 78 1/ 0/ 1 1/ 0/ 4 Focus
InnoSight Ultrasound System To select/enable or deselect/disable a function, tap in the checkbox For example, check Registered User uncheck Site Administrator User Information Conventions The User Manual uses certain conventions throughout the book to make it easier to find the information you need Control names and menu items or titles are spelled as they are on the system, and they appear in bold text The on-screen menu steps needed to perform a function are shown in a condensed form For example, touch
InnoSight Ultrasound System 1 P69 92- 4 , EN, 16/12/ 6
2 2 Safety Information Follow the procedures carefully and ensure that the power/electrical/environmental requirements are satisfied Failure to observe the instructions or disregard the warnings may result in damages to the system, personal injury, or even death of the operator or the patient Observe the following precautions carefully This system complies with Type BF general equipment and the EN6 6 1-1 standard, suitable for continuous operation when connected as a system to a medical grade AC/DC power
InnoSight Ultrasound System Do not use this system under direct sunlight, near heat sources or in the presence of flammable substances, otherwise an explosion may occur When using this system for ultrasound examinations, use only the qualified ultrasound gel that complies with system standards Do not continuously scan the same part of a patient or expose the patient to prolonged scanning, otherwise it may harm the patient Do not stay at the same position for too long without taking a break while scanning p
InnoSight Ultrasound System Symbols Descriptions SVC Philips Service Code UDI Unique Device Identification Manufacturer Mark Manufacturer Qisda Corporation manufactures the system Manufacture Date 201X-XX-XX EU/EC European Authorized Representative 0120 CE Marking Certification with Notified Body Number 0120 Compliance to R&TTE Directive Notify Body Certificate 710435 Final Disposal of Your System Final disposal is when you dispose of the system in such a way that it can no longer be used for its
InnoSight Ultrasound System Shipping Label Icons Symbols Descriptions This Side Up Fragile Maximum Stacking Height Sun and Rain Temperature The system must be stored in the original shipping container in environments between -2 C and 6 C (-13 F and 14 F) The temperature while operating the system should be kept between 1 C and 4 C (32 F and 1 4 F) Humidity The system must be stored in the original shipping container in environments with 2 to 9 relative humidity and non-condensing The humidity while o
InnoSight Ultrasound System Electrical: » IEC 6 6 1-1:2 AMD1:2 12, EN 6 6 1-1:2 6 A12:2 14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance » IEC 6 6 1-1-2:2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests CISPR 11: 2 1 AMD1:2 16 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics
InnoSight Ultrasound System Battery Usage/Disposal Do not disassemble the system Use only the supplied battery Using an unapproved battery may cause the system to explode and result in serious damage to your health or property Do not replace, heat, crush, puncture, short external contacts, or incinerate the battery Use only the supplied power adapter to charge the battery Incorrect use of the battery may cause a leak of chemicals or explosion The leak of chemicals may harm the skin If any chemicals leak fr
InnoSight Ultrasound System Emissions test Compliance Electromagnetic environment - Guidance RF Emissions CISPR 11 Class B The InnoSight Diagnostic Ultrasound System is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonics IEC 61 Flicker IEC 61 -3-2 Class A or B -3-3 Complies RF Emissions CISPR 14-1 Complies The InnoSight Diagnostic Ultrasound System is
InnoSight Ultrasound System IEC 60601 test level Immunity test Radiated RF IEC 61 -4-3 3 V/m MHz to 2 GHz Compliance level E1 3 V/m Electromagnetic environment - Guidance d d 3 E1 7 E1 P MHz to P MHz MHz to 2 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less
InnoSight Ultrasound System Maximum Output Power of Transmitter Watts (W) Separation Distance According to Frequency of Transmitter Meters (m) 1 kHz to MHz 3 P D V1 MHz to 3 P E1 MHz MHz to 2 GHz P D E1 D 1 3 69 m 3 69 m 3 m 1 11 6 m 11 6 m 23 34 m Ta le 1 Separation distances For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
InnoSight Ultrasound System To avoid injury, we recommend against lifting the system cart Never park the system cart on an incline If you park the system on a floor that is tilted 1 degrees or more and set the brakes, one of the braked casters might not be touching the floor, which can cause the system to move When performing a needle biopsy, if the system is not mounted correctly on the system cart, or if the system cart is not parked safely, unintended movement of the system resulting in movement of the
InnoSight Ultrasound System Biological Safety This product, as with all ultrasound equipment, should be used only for valid reasons and should be used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As Reasonably Achievable) to produce diagnostically acceptable images The AIUM offers the following guidelines: Clinical Safety Quoted from AIUM Approved March 26, 1997 Diagnostic ultrasound has been in use since the late 1950s.
InnoSight Ultrasound System Take particular care to reduce output and minimize exposure time of an embryo or fetus when the temperature of the mother is already elevated Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when exposing an embryo less than eight weeks after gestation, or the head, brain or spine of any fetus or neonate Although applicable to any transducer, take particular care during trans-vaginal exams during the first eight weeks of gestation During con
InnoSight Ultrasound System FDA Medical Alert on Latex March 29, 1991, Allergic reactions to latex-containing medical devices Because of reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA is advising health care professionals to identify their latex sensitive patients and be prepared to treat allergic reactions promptly Patient reactions to latex have ranged from contact urticaria to systemic Latex is a component of many medical devices, including surgical an
InnoSight Ultrasound System Repetitive Strain Injury Repetitive ultrasound scanning has been associated with carpal tunnel syndrome (CTS) and related musculoskeletal problems Some investigators have looked at a large population of sonographers with different types of equipment An article, with feedback from a smaller geographical area, makes the following recommendations: Maintain your joints in optimum positions with a balanced posture while scanning Allow frequent breaks to give soft tissue a chance to r
InnoSight Ultrasound System Position the disposable drape so that it does not block the vents on the system, the monitors, or the peripherals Waterproof and Dustproof Ratings The system has a degree of protection from ingress of water and particulate matter, but the tablet is not approved for use where it would be exposed to liquids If it is used in environments where it might be exposed to liquids, the tablet must be covered by a drape, such as a Civco 66 -1 6 These environments include, but are not limi
InnoSight Ultrasound System Mode / Transducer C6-2 Curved Linear Array 2-6 MHz L12-4 Linear Array 4-12 MHz S4-2 Phased Array 64 elements 2-4 MHz C9-4v Micro Curved Linear Array 4-9 MHz 2D 2D M-Mode THI, 2D THI, 2D M-Mode PW Doppler 2D Color V THI Color, 2D V Ta le 4 MI/TI generating from applicable transducer/mode combinations Track-3 follows the Output Display Standard for systems which include fetal Doppler applications The acoustic output will not be evaluated on an application-specific basis,
InnoSight Ultrasound System De-rating factor RF for the various distances and frequencies with attenuation coefficient 3 dB cm-1 MHz1 in homogeneous soft tissue is listed in the following table An example is if the operator uses MHz frequency, the power will be attenuated by at cm, or 3 x x -11 2 dB The De-rated Intensity is also referred to as 3’ at the end (e g Ispta 3) Distance (cm) Frequency (MHz) 1 3 5 7.
InnoSight Ultrasound System Display Guideline Thermal Index (TI) consists of two indices: soft tissue (TIS) and bone (TIB) TIB is only displayed in nonscanning modes, such as M-mode, PW mode and CW mode TIS is displayed in all scan modes The index is continuously displayed over a range of 1 to 6 in increments of 1 Mechanical Index (MI) is continuously displayed over a range of 1 to 1 9 in increments of 1 Display and Report in Different Modes For 2D Mode Display and report only MI and TIS For Color Mode D
3 3 Overview Acquaint yourself with the system and its components in this chapter System Capabilities The InnoSight Diagnostic Ultrasound System is intended for Obstetric imaging, and OB/GYN, Gynecology imaging, Cardiac imaging, Vascular imaging, and general imaging purpose, and related analysis The system cart is ergonomically designed to be both highly mobile and adjustable for a range of users and operating conditions The system can be used for 2D grayscale, M-Mode, Color, Doppler, PW, and CW imaging
InnoSight Ultrasound System Calculations Calculations are organized in collections for the applications included in the system The system uses measurement values to make calculations and create a patient report Image Acquisition and Review You can acquire and review single images and cineloop sequences Images and cineloop sequences can be stored on USB devices, or sent over a wireless network to an archive server, or printed out from supported external printer Patient Data Protection The data security fe
InnoSight Ultrasound System System Overview Front and Side Views 2 1 2 12 11 10 9 8 7 3 6 5 No.
InnoSight Ultrasound System The system supports access to only one external storage device at a time If you connect more than one external storage device, they function in the following priority order: USB 3 USB 2 microSD card Rear and Top/Bottom Views 13 14 14 15 16 17 No.
InnoSight Ultrasound System Transducer Overview 1 2 3 8 4 7 Figure 3 5 6 Transducer overview (Example transducer: C6-2) No. Component No.
InnoSight Ultrasound System System Cart Overview The system cart is available for purchase as an optional item Front View 1 1 5 4 2 3 3 No. Item No.
InnoSight Ultrasound System Rear View 6 7 8 9 9 10 11 10 No. Item 6 nurled thumb knob No.
InnoSight Ultrasound System Indications for Use and Supporting Transducers InnoSight Diagnostic Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), heart soft tissue, Peripheral Vascular, Musculoskeletal, Fetal and OB/GYN The following tables provide Diagnostic Ultrasound Indications for Use Forms for the transducers offered with the InnoSight Diagnostic Ultrasound System DI
InnoSight Ultrasound System N new indication P previously cleared by FDA E added under this appendix Note 1: Combined modes include: 2D M-Mode 2D PW Doppler 2D Color 2D CPA 2D Color PW Doppler and 2D CPA PW Doppler DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: InnoSight Diagnostic Ultrasound System Transducer: C6-2 (Curved Linear Array 2-6 MHz) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application Mode of operation General Specif
InnoSight Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: InnoSight Diagnostic Ultrasound System Transducer: L12-4 (Linear Array 4-12 MHz) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application Mode of operation General Specific (Track 1 only) (Track 1 and 3) Ophthalmic Fetal imaging and others Cardiac Peripheral vessel 2D Ophthalmic Fetal Abdominal Intra-operative Specify Intra-operative Neuro Laparoscopic Pedia
InnoSight Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: InnoSight Diagnostic Ultrasound System Transducer: S4-2 (Phase Array 64 elements 2-4 MHz) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application Mode of operation General Specific (Track 1 only) (Track 1 and 3) Ophthalmic Fetal imaging and others Cardiac Peripheral vessel 2D Ophthalmic Fetal Abdominal Intra-operative Specify Intra-operative Neuro Laparosco
InnoSight Ultrasound System DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM System: InnoSight Diagnostic Ultrasound System Transducer: C9-4v (Micro-curved Linear Array 4-9 MHz) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical application Mode of operation General Specific (Track 1 only) (Track 1 and 3) Ophthalmic Fetal imaging and others Cardiac Peripheral vessel 2D Ophthalmic Fetal Abdominal Intra-operative Specify Intra-operative Neuro Laparo
4 4 Preparing the System Follow the information and procedures in this section to help you prepare the system for use Inserting a microSD Card Use the microSD card to import/export data to/from your system, such as patient information or user settings Supported microSD card format: SD C (up to 12 GB) SDHC Class 1 (up to 32GB) The microSD card is not supplied with the system 1 Flip the port cover open 2 Align the microSD card with the mark next to the microSD card slot 3 Fully insert the microSD car
InnoSight Ultrasound System Using the Stand 1 Rotate the rotating stand clockwise by 9 degrees Lay the rotating stand completely flat before rotation 2 Gently pull out the rotating stand to the degree that suits your preferred viewing angle 40 Using the Stand ep in e e P69 92- 4 , EN, 16/12/ 6
InnoSight Ultrasound System Charging the System The system is only partially charged when first unpacked Charge the battery fully for the system for the first time hours before using Use only the supplied power adapter and AC plugs for charging AC plug and electric outlet types vary by country/region a Do not try to repair or replace the battery or the power adapter Any attempt to disassemble the system and the supplied accessories may cause damage to the system or result in personal injury a 3 1 4 1
InnoSight Ultrasound System Connecting the Transducer Flip the transducer cover open a and insert the transducer carefully into the transducer connection socket until it is locked in place a Removing the Transducer Press and hold the release latch, and carefully pull out the transducer 42 Connecting the Transducer ep in e e P69 92- 4 , EN, 16/12/ 6
InnoSight Ultrasound System Using the System On The Go 1 Rotate the rotating stand counterclockwise by 9 degrees Lay the rotating stand completely flat before rotation 2 Use the rotating stand as a handle to carry the system around P69 92- 4 , EN, 16/12/ 6 ep in e e Using the System On The Go 43
InnoSight Ultrasound System Using the Wheel Brakes Use the brakes on the system cart wheels to help keep the cart stationary while in use To engage the brakes, press down on the lever with your foot To disengage the brakes, push the levers upward with your foot until they are fixed in place Never park the system cart on an incline If you park the system on a floor that is tilted 1 degrees or more and set the brakes, one of the braked casters might not be touching the floor, which can cause the system to m
InnoSight Ultrasound System Mounting the System to the System Cart The system cart is available by separate purchase Before mounting the system to the system cart, ensure that the caster wheels are locked in place, and the rotating stand is fixed as a handle (See page 43) 1 Hold the system firmly and position it precisely to the front of the mount plate on the cart where the four screws on the back of the system and the hole patterns of the plate meet 2 Attach the system fully onto the plate until you h
InnoSight Ultrasound System Adjusting the System Cart Height Adjust the height of the system cart to suit different operators and operating positions 1 Open the protective cover 2 Press and hold the height adjustment button to loosen the cart pillar Without releasing the button, slide the cart pillar up and down until the desired height is reached 3 Release the button to lock the pillar in place 46 Adjusting the System Cart Height ep in e e P69 92- 4 , EN, 16/12/ 6
InnoSight Ultrasound System Connecting an External Printer Before connecting the system to an external printer, turn off the system and disconnect the power adapter from the power outlet External printers are available by separate purchase For a list of supported printers, see Supported External Printers on page Before connection, secure your printer onto the printer holder with the straps 1 Insert one end of an USB cable into your printer’s USB port 2 Insert the other end of the USB cable into the sys
InnoSight Ultrasound System Turn on the printer, then turn on the system The system installs the printer drivers automatically 6 After successful installation of the new printer drivers, on the system imaging screen, go to Menu Settings Print and select the printer name The printer is now ready for use See your printer documentation included in the sales package for detailed information on connections and settings Tilting the System Your system, while mounted on the system cart, can be rotated and tilted
InnoSight Ultrasound System Unmounting the System From the System Cart Pull out the knurled thumb knob to unlock the system a , and simultaneously lift the system from the mount plate b b a Moving the System Before moving the system mounted on the system cart, secure all cables, transducers, and accessories so that they do not interfere with the caster wheels Observe the precautions and warnings below and listed in Mechanical Safety on page 1 before moving the system mounted on a cart Ensure that the ca
InnoSight Ultrasound System Outputting the System Display to an HDMI-Enabled TV or Monitor 1 Insert one end of an HDMI cable to the system’s HDMI port Ensure that the arrow side faces up 2 Insert the other end of the HDMI cable to your HDMI-enabled TV’s or monitor’s HDMI port 3 Connect the TV or monitor to power 4 On the TV or monitor, select the proper input source See the documentation of your HDMI-enabled television or monitor for detailed information on connections and settings Supported Extern
5 5 Using the System Before performing an ultrasound exam, understand and learn the features of the system Turning On/Off the System Press and hold the Power button to turn on the system The system enters the user login screen after system startup Press and hold the Power button until the Power off menu appears on the screen, then touch OK to turn off the system If the system is turned off abnormally, powering on the system the next time will take longer than usual for a system hardware check If the sys
InnoSight Ultrasound System Creating a New Administrator Account 1 After system startup, the default user account with administrative privileges appears on the screen To begin the first-time-logging-in process, touch the account name, enter the default password and touch Login Default User ID: SiteAdmin Default Password: System’s serial number To check your system’s serial number: On the system imaging screen, touch Menu > Settings > About Refer to the system label on the back of the system Each time afte
InnoSight Ultrasound System Managing User Settings The users without administrative privileges can modify personal credentials as well as limited security settings To modify personal credentials, touch Menu > Security > User Edit To set an automated logout after a specified period of inactivity, touch Menu > Security > Security Policies Launching the Main Screen After successfully logging in as a registered user, one of the following main screens appears If no transducer is connected, the system enters th
InnoSight Ultrasound System If a transducer is connected and the system displays the message No probe is connected , remove then re-connect the transducer If the system still cannot detect the transducer, turn off the system Wait for a few seconds and restart the system You can choose the screen to enter after starting and logging in the system (with the transducer connected) Go to Menu > Settings > Workflow > Screen after Enter Ultrasound Setting the System Time and Date Managing pertinent patient data a
InnoSight Ultrasound System Controlling the System The system requires operations with multi-touch controls by finger movements called gestures Alternatively, you can add pointing or input devices by connecting them to the USB ports on the system Touch Touch and Hold Drag Double-Tap Press and Tap Two-Finger Tap Pinch Spread x2 Flick Figure 6 Gestures Gestures for Controlling the Real-time/Frozen Imaging Screens Action Toggle between Real-time and frozen imaging screens Gesture Double-tap on t
InnoSight Ultrasound System Action Gesture Display the second control On the control panel area, flick right to display the second page, flick left panel page/Return to the to return to the first page (See Switching the Control Panel Pages on first control panel page page 62) Gestures for Controlling the Real-time Imaging Screen Action Gesture Adjust depth Flick vertically on the scan area to increase (flick down) or decrease (flick up) depth Adjust gain Flick horizontally on the scan area/time ser
InnoSight Ultrasound System If you are unsure of a function displayed in localized languages, switch the system language back to English, and check again the function you want to use If the problem persists, contact technical support (See Customer Service on page 3) Identifying the Main Screen Layout System Menu Screen Touch Menu to display the following system menu screen Touch an icon to perform its function 1 2 3 4 Patient Worklist Exam List Report Preset Review Settings Security 8 7 6
InnoSight Ultrasound System Imaging Screen (Real-time) With the transducer connected correctly, the system enters the real-time imaging screen each time after pressing the Home button 1 3 2 4 5 6 8 7 9 10 11 Menu 2D Color M CPA Transducer MI TIS PW 12 Focus 8.0 13 Dyn Range 78 THI Full Screen Dual Toggle 14 5 2D Freeze Acquire Fn Key Figure 8 iScan TGC Home Pen Res End Exam Real-time imaging screen (example) No. Function No.
InnoSight Ultrasound System Menu 28 2D Color M CPA Transducer MI TIS PW Focus 8.
InnoSight Ultrasound System Imaging Screen (Frozen) During an exam, touch Freeze to review all the ultrasound images stored in the cine buffer frame by frame, or play back these frames in a continuous loop You can also measure, calculate and add annotations to the frozen images or loops 1 Control panel 2 Menu 13 Distance Depth Ellipse Trace Angle Calc IMT Erase Meas Annot Label Arrow Body Mark 12 Transducer MI TIS Erase Annot 11 Report 10 Play 5 2D Acquire Freeze 9 8 Fn Key
InnoSight Ultrasound System System Tools Touch anywhere on the system toolbar to open the system tools menu Touch an item to adjust its setting System toolbar 12/5/2016 08:56 AM Menu Abdomen 12/5/2016 Monday 2D Color AM PW 8:56 M Long press button to launch settings CPA page. 9 1 2 Focus 8.0 8 3 Lan Connected 7 C6-2 MI 0.72 TIS 0.03 76 Hz 16.
InnoSight Ultrasound System To switch the keyboard input language, touch on the virtual keyboard and select your target language Scan Properties Display The imaging window includes a text display information about the current scan 5 1 15 C6-2 MI 1.04 TIS 0.28 12 Hz 12.0 cm 2D Gen Gn 41 Color Gen Gn 47 1/ 1/ 5 Filter 20.0Hz 1 2 3 4 -15 Figure 14 Scan properties display (example) No. Function No.
InnoSight Ultrasound System Use buttons: 12/5/2016 08:56 AM Menu Color M CPA 12/5/2016 08:56 AM Menu Abdomen 2D PW Abdomen Persist 4 XRES 1 Gray Map 1 Chroma 0 Focal Zone 1 Focal Span 1 1 1 Page 1 Focus 8.
InnoSight Ultrasound System Battery Status Icons The battery level is indicated by icons shown on the system toolbar Battery status icon Meaning The battery is fully charged The battery is to 99 charged The battery is 6 to 9 charged The battery is 4 to 9 charged The battery is 2 to 39 charged The battery is critically low The battery is charging The battery cannot be identified Battery temperature is too high or too low and the battery stops charging When the battery level reaches a critically lo
InnoSight Ultrasound System Network Configuration The system network is configured from the system tool menu (See page 61) The configuration information for the system includes the IP address, port number, and other attributes required for transmitting images and other study data across a network The system network must be configured before you use either the standard network support or the capabilities available through the DICOM networking options Connecting the System to the Network by Ethernet 1 Conn
InnoSight Ultrasound System Connecting the System to a Bluetooth Device You can connect the system to another pointing or input device via Bluetooth Using features requiring a Bluetooth connection may consume more battery power To extend battery life between charges, turn off Bluetooth when not using it Maximum distance between two connected Bluetooth devices cannot exceed meters 1 Open the system tools menu (See page 61) 2 Touch 3 The system scans for and displays the IDs of available Bluetooth devic
InnoSight Ultrasound System 2 Assign a name to the server and enter it in the Name field 3 Enter the IP Address, Port and AE Title specified by your network administrator in the respective fields 4 To test the server connection, touch Test in the Echo Test section A verification message confirms a successful connection within a few seconds Repeat step 1-4 to add more servers based on your needs If you add a second storage SCP, when you export an exam or an image/video to the DICOM server, two tasks ar
InnoSight Ultrasound System 68 P69 92- 4 , EN, 16/12/ 6
6 6 Performing an Exam To perform an exam, complete the general procedure: 1 Start an exam It can be a new exam, or a previously saved/paused exam To start a new patient exam, add a new patient (Patient screen) To load a work list (Worklist screen) To resume a previously saved/paused exam (Exam List screen) 2 Select an exam type and preset (Preset screen) 3 Start real-time imaging (Imaging screen (Real-time)) 4 Set the transducer orientation (See page 3) Select a scan mode (See page 3) and adjust
InnoSight Ultrasound System Adding a New Patient 1 On the imaging screen, touch Menu > Patient Patient Menu Patient information Last Name Middle Name First Name New Patient ID Start Exam Gender DOB Age Exam Information Abdomen Cardiology Height cm Blood Press Accession Referring Physician GYN Weight / OB kg BSA Small Part 2 m Urology Heart Rate Vascular bpm mmHg Institution Operator Interpreting Physician Description Comment Home Previous End Exam Figure 15 2 Patient screen
InnoSight Ultrasound System Loading a Worklist The system conforms with the Digital Imaging and Communications in Medicine (DICOM) standard, which is the industrial standard for the communication and management of patient data between devices in the hospital You can load patient information in a worklist via the DICOM server For more information on configuring DICOM settings, see DICOM Configuration on page 66 1 On the imaging screen, touch Menu > Worklist Menu Worklist Query Worklist Start Exam Name
InnoSight Ultrasound System Selecting a Preset The system provides predefined presets for all supported transducers Choosing an exam loads optimized presets for image control settings, based on the anatomy to be scanned, the transducer used, and the scan mode The presets also specify the measurements appropriate for the exams You can directly use the optimized presets, or adjust any of the image control settings as necessary for the specific patient and the specific exam 1 On the imaging screen, touch Men
InnoSight Ultrasound System Exporting and Importing Customized Presets On the preset screen, touch Export/Import to export/import customized presets to/from your external storage Setting the Transducer Orientation Upon entering all scan modes, the orientation marker ( ) displays at the default location (usually at the top left side of the image), and suggests you the direction of holding the transducer The orientation marker on the screen corresponds to the position of the orientation marking on the side
InnoSight Ultrasound System 1 On the imaging screen, touch image > Zoom The ROI (Region of Interest) box appears on the center of the 12/5/2016 08:56 AM Menu Abdomen Depth Gain 44 3 Sector Width 256 Sector Pos 2D Gen Gn 44 DR 78 1/ 0/ 1 3/ 0/ 6 ROI box Power 80.0 Annot Body Mark Zoom Label Arrow C6-2 MI 0.72 TIS 0.02 32 Hz 16.
InnoSight Ultrasound System When in 2D Mode: On the imaging screen, touch Dual The system immediately freezes the current scan, and copies the current settings for the image to the second screen Two yellow bars will be added to the top/bottom of the currently active screen To toggle between screens, touch Toggle Only one screen can be active at a time 12/5/2016 08:56 AM Menu Abdomen 2D Color M CPA PW 3 3 C6-2 MI 0.72 TIS 0.02 32 Hz 16.0 cm 2D Gen Gn 44 DR 78 1/ 0/ 1 3/ 0/ 6 Focus 8.
InnoSight Ultrasound System Freezing an Image During a real-time scan, touch Freeze to freeze live ultrasound images recorded by frame and stored temporarily in the cine buffer Depending on the mode selected, a certain number of frames are recorded To play back saved images in a continuous cine loop, touch Play To adjust the playback speed, touch > Loop Speed +/- To view the saved images frame by frame or to find a specific frame, touch indicator / or drag the frame horizontally To restart a new rea
InnoSight Ultrasound System 2 Type the texts directly Touch Done on the keyboard to finish inputs 3 Drag the text cursor to where you want the new texts to be, and release it to place the texts b Setting the Text Home Position You can choose a specified position in the image display as the starting location, which is the text home position 1 Move a set of existing texts to the desired text home position 2 Touch the texts directly, and touch Done to close the keyboard 3 Touch Set home To restore th
InnoSight Ultrasound System 2 Select a body mark A pictogram of the body mark with a transducer indicator displays on the image Figure 25 Pictogram of the body mark (example) 3 Touch anywhere on the image, and drag the transducer indicator to the desired location on the body mark 4 Touch anywhere on the image and move to rotate the transducer indicator Touch and hold the pictogram, and drag it to the desired location on the image To delete annotations, including texts and arrows, touch Erase Annot t
InnoSight Ultrasound System When you are measuring, the indicators/lines display in yellow, allowing you to adjust as many times as needed When you are done with measuring, use any of the following methods to complete the measurement The indicators/lines then turns green, and the measured results (values) appear on the top left side of the imaging screen Two-finger tap on the scan area Proceed with the next measurement Touch Acquire to save the ultrasound image To re-position the measured results, touch Re
InnoSight Ultrasound System 3 When the tracing is nearly done, release the cursor and the system completes the loop by drawing a line from the current cursor position to the starting point c Angle Measure an angle 1 Touch Angle A crosshair cursor appears on the image Drag the target cursor to the desired location and release it to set the start point of measurement 2 Drag the first target cursor along one side of the desired area, and release it to draw the first line 3 Drag the second target cursor
InnoSight Ultrasound System Slope Measure the length between the intersections of two cursors Slope can be positive or negative and measures the rate of change between the two points defined by the intersections of the cursors in cm/sec 1 Touch Slope A crosshair cursor with horizontal and vertical axes appears on the time series window Drag the cursor to a desired start point and release it 2 A second cursor appears Drag it to the end point then release it to complete measurement The slope measurement i
InnoSight Ultrasound System Trace Manually trace the Doppler spectrum 1 Touch Semi Trace A crosshair cursor with vertical axis appears on the time series window Drag the cursor to a desired peak of the graph and release it 2 A second cursor appears Drag it to end diastole on the graph then release it 3 A third cursor appears Drag it to the second peak of the graph and release it to complete the trace Velocity Measure the blood flow velocity Display item Contents (units) V Flow Velocity (mm/s) PG
InnoSight Ultrasound System Saving an Image Loop On the real-time imaging screen, touch Acquire to save a default set of frames as an image loop The saved image loop will be displayed in the thumbnail list Saving an Image On the frozen imaging screen, touch Acquire to save the current frame as an image The saved image will be displayed in the thumbnail list Printing an Image On the frozen imaging screen, touch Print to print out the current image Reviewing the Image On the frozen imaging screen, flick v
InnoSight Ultrasound System Performing Multiple Selections You can perform actions to more than one image/loop at a time 12/5/2016 08:56 AM 12/5/2016 08:56 AM 1 Add to Report Report Export exam Delete 12/5/2016 08:56 AM Abdomen Abdomen Menu 3 Abdomen C6-2 MI 0.72 TIS 0.03 18 Hz 16.0 cm 1 2D Gen Gn 39 DR 80 1/ 0/ 1 1/ 0/ 4 2 12/5/2016 08:56 AM 1 1 C6-2 MI 1.04 TIS 0.34 12 Hz 12.0 cm 12/5/2016 08:56 AM Cardiac 1 Color Gen Gn 47 1/ 1/ 5 Filter 20.0Hz 15 15 C6-2 MI 1.04 TIS 0.
InnoSight Ultrasound System Generating a Report 1 On the review screen, touch the thumbnails of the desired images and touch Add to Report 2 Touch Gen Report to display the following screen Menu Study date: 2015/09/03 Report Liver Institution: Print Print Preview Referring: Interpreting: 1 column Signature: Template Cardiac Add Image Exam List Delete Image Export Patient information Last Name M.I.
InnoSight Ultrasound System 2 On the report screen, touch Export Touch Export exam to DICOM, Export exam to external storage or Export media image to external storage To set the default export directory, export to DICOM automatically after ending the exam and more, touch Menu > Settings For more information on configuring DICOM settings, see DICOM Configuration on page 66 Managing the Exam List You can check and update status of all the stored exams from the Exam list screen On the imaging screen, touch
InnoSight Ultrasound System Exporting Exams To export exams, multi-check the exams , touch Export Exam and select an export method The task status icon (See page 6 ) next to the checkbox indicates the uploaded result of the exam Importing Exams Multi-check the exams and touch Import from an external storage Ending the Exam An exam is not complete if you proceed with a new exam without ending the previous one To end the exam, touch End Exam on the imaging screen To check the exam status, go to Menu > Exa
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7 7 Using Image Controls All of the information in this chapter pertains to real-time imaging Many of the controls and functions change when you freeze the scan For information on using functions when the scan is frozen, see Adding Annotations on page 6 and Adding Measurements on page On the real-time imaging window: Touch the scan mode (image control) buttons to select the scan mode (See Imaging Screen (Real-time) on page ) Touch > to switch the control panel pages to go through the available functions
InnoSight Ultrasound System Adjusting Time Gain Compensation (TGC) Adjust the gain which compensates for the attenuation (a reduction in sound amplitude) of the echo signals in proportion to their depth (based on travel time) Touch TGC to display the TGC sliders on the screen To increase/decrease the gain at the desired section (depth) of the image, drag the corresponding slider to the right/left Adjusting the Scan Depth Adjust the field of view To view larger or deeper structures, increase the depth To e
InnoSight Ultrasound System Adjusting Chroma Map Adjust the chroma (color tone and saturation) value with different brightness Touch Chroma +/- to adjust the tone Adjusting Steer Angle Optimize the viewing area by adjusting the steer angle This function works only with linear array transducers Touch Steer +/- to adjust the angle Adjusting the Sector Width and Position Adjust the ROI of the imaging area for image width and image position A smaller sector width increases the frame rate Touch Sector Width +
InnoSight Ultrasound System A patient profile is selected Touch ENV to enable this function A diverging dotted green line show in the Imaging window The point of the needle should be close to vertical to the dotted line The part of the needle image that goes beyond the limit will not be brightened and can’t be seen Tap ENV Angle repeatedly, if needed, to toggle between lines angled from upper left to lower right and lines angled from upper right to lower left The system does not support the biopsy guide fu
InnoSight Ultrasound System In CPA (Color Power Angio) mode, low flow rate in small vessels are clearly observed Colors are carried out only to demonstrate the blood flow, but contain no velocity information, thus, offer no directional information 2D C6-2 PW 1 M 2D 5 2D TGC Figure 36 CPA mode real-time scan Both Color and CPA modes can work with other scan modes to form duplex and triplex modes Adjusting Pulse Repetition Frequency (PRF) Adjust the velocity range of the color flow display The ma
InnoSight Ultrasound System Inverting the Color Display Invert the color display in relation to the blood flow direction in Color mode Normally, the color red is assigned to positive frequency shifts (flow toward the transducer), and blue is assigned to negative frequency shifts (flow away from the transducer) Use this function to reverse this color assignment and invert the colors on the color wedge Touch Invert to invert the color scale Using Directional Power Activate Directional Power in CPA mode for
InnoSight Ultrasound System Using Steer M Allow steering the sample volume to any angle you choose by adding multiple M-lines, rather than sampling in a strict vertical position This function is particularly useful in cardiological applications 1 Touch Steer M + 2 A crosshair cursor appears on the image Drag the cursor to where you want to start sampling and release it 3 Drag the cursor to where you want to end sampling and release it 4 Touch Steer M + to add a second line Repeat step 2-3 to place i
InnoSight Ultrasound System Drag the sample gate to the proper location 2D PW M CW 1 2D 5 PW Zoom -60,0,60 5 2D PW TGC Figure 38 PW Doppler mode real-time scan CW mode examines the flow data along the Spectral Doppler cursor rather than a small region 2D PW M CW 1 2D 5 CW Zoom 5 2D CW TGC Figure 39 CW Doppler mode real-time scan Adjusting Baseline Adjust the zero baseline up or down in the Time Series window Touch Baseline +/- to adjust the value Touch and hold the baseline in Ti
InnoSight Ultrasound System Adjusting Correction Angle Adjust the correction angle to obtain accurate velocity At angles greater than calculation is usually too large to use To toggle the angle between -6 , the error in the velocity and 6 , touch Angle -60,0,60 repeatedly To manually adjust the angle, touch and hold one finger on the scan line, then flick another finger to the left or right Updating the 2D Display Select whether or not to continue scanning the anatomy while acquiring PW Doppler scan da
InnoSight Ultrasound System 98 Spectral Doppler Mode Image Controls in e n P69 92- 4 , EN, 16/12/ 6
8 System Customization and Service 8 Customizing Your System You can customize your system to streamline your workflow and increase efficiency Use the setup tools to adjust sets of controls for defaults and other settings On the system, touch Menu > Settings The setup tools are categorized into various sections Touch each section to access the settings General Dock Control Panel at: Set the control panel at the left or right side of the screen Enable freeze gesture: Enable double-tapping the screen to f
InnoSight Ultrasound System Body mark Auto-clear Body Mark after Unfreeze: Enable clearing the body mark added automatically after returning to the real-time scan Auto-add Body Mark after Live Scan: Enable adding a body mark each time you start a new scan Annotation Auto-clear Annotation after Unfreeze: Enable clearing all the annotations added automatically after returning to the real-time scan Measurement Auto-clear Measurement after Unfreeze: Enable clearing all the measurements added automatically af
InnoSight Ultrasound System Label List: Touch Edit, select an application and check/uncheck each label to re-arrange the label list, then touch Save Body Mark Default Body Mark for Application: Touch Edit, select an application and touch a desired body mark to set it as default, then touch Save Body Mark List: Touch Edit, select an application and enable/disable each body mark to re-arrange the body mark list, then touch Save Measurement User Defined Measurement List/User Defined Calculation List: Custom
InnoSight Ultrasound System Print Image Printer/Report Printer: Assign the printer for use when printing images/reports Network Printing: Configure printer settings Image Color Invert: Print out the image with colors inverted Configuring Security Policies After creating user accounts, the administrator needs to enable the data security feature in order to protect patient data Before security configuration, log in as the administrator The ID/Name of the administrator are shown in the Current User section
InnoSight Ultrasound System On the system, touch Menu > Settings > Service The service tools are categorized into the following sections Managing your system: Touch System Management System information, software update and backing up and restoring data can be found here Testing your system: Touch Test & Utilities Use the diagnostic tools here to test the system functionality Exporting system logs: Touch System Logs Test results of the system functionality can be found here About your system: Touch About Th
InnoSight Ultrasound System Resetting User Settings Performing this action will reset all system settings of the current user and is irreversible Consider backing up your settings to an external storage device first Touch System Management > (System Configuration) > (Reset Configuration) > Reset Backing Up System Settings and Patient Data Before backing up system settings and patient data, ensure that the system is connected to an external storage device It is recommended that you perform regular backups
InnoSight Ultrasound System Exporting System Logs Before exporting system logs, ensure that the system is connected to an external storage device After testing the system, the test results will be logged and available for review You can view all task records concerning DICOM transmission from the System Logs window, or export the log file to an external storage device and send it to your service contact (See Customer Service on page 3) Touch System Logs > Export Reading the User Manual This User Manual is
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9 9 Transducers The transducer is the most important factor in image quality Optimal imaging cannot be obtained without the correct transducer The system is optimized for use based on your transducer selection Transducer Maintenance Transducers require proper care, cleaning, and handling Reasonable care includes inspection,cleaning, and disinfection or sterilization, as necessary Inspect the transducer, cable, and lens before each use Check for cracks or other damage that jeopardizes the integrity of th
InnoSight Ultrasound System Acoustic saturation occurs when received signals reach a system’s high-amplitude limit At that point the system becomes unable to distinguish or display signal intensities At the point of saturation, increased input will not increase output Aliasing occurs when the detected Doppler frequency exceeds the Nyquist limit It is characterized on the spectral display by the Doppler peaks going off the display, top or bottom, and then continuing on the other side of the baseline On the
InnoSight Ultrasound System Speckle appears as tissue texture close to the transducer but does not correspond to scatterers in tissue It is produced by ultrasound wave interference and results in general image degradation Spectral broadening is a display phenomenon that occurs when the number of energy-bearing Fourier frequency components increases at any given point in time As a consequence, the spectral display is broadened Spectral broadening can indicate the disturbed flow caused by a lesion, and there
InnoSight Ultrasound System Transducer Storage Use the appropriate guidelines for storing transducers for transport, and daily and long-term storage For information on temperature and humidity requirements, see Appendix A: Specifications on page 12 Storage for Transport If a carrying case is provided with your transducer, always use the carrying case to transport the transducer from one site to another Follow these guidelines to properly store transducers for transport: Make sure that the transducer is cl
10 10 Transducer Care All Philips transducers require proper care, cleaning, and handling This section contains information and instructions to help you effectively clean, disinfect, and sterilize the transducers that are compatible with your system Additionally, these instructions help avoid damage during cleaning, disinfection, and sterilization, which could void your warranty Reasonable care includes inspection, cleaning, and disinfection or sterilization, as necessary Transducers must be cleaned afte
InnoSight Ultrasound System If a pre-mixed solution is used, be sure to observe the solution expiration date Transducers must be cleaned after each use Cleaning the transducer is an essential step before effective disinfection or sterilization Be sure to follow the manufacturer’s instructions when using disinfectants When sterilizing a transducer, ensure that the sterilant solution’s strength and duration of contact are appropriate for sterilization Be sure to follow the manufacturer’s instructions Follow
InnoSight Ultrasound System Latex Product Alert Transducer covers may contain natural rubber latex Those covers may cause allergic reactions in some individuals For information on allergic reactions to latex-containing medical devices, see FDA Medical Alert on Latex on page 21 Inspecting the Transducer Inspect the transducer’s acoustic lens, outer cover, the cable, and the transducer connector before each use Check the transducer carefully and see if there are cracks, cuts, or any other damages which may
InnoSight Ultrasound System Always use protective eyewear and gloves when cleaning and disinfecting any equipment When cleaning and disinfecting transducers, do not allow any fluid to enter electrical connections or metal portions of the connector Damage due to fluids in these areas is not covered by the warranty or your service contract Cleaning Instructions 1 After every patient exam, use a moist cloth to remove the ultrasound transmission gel from the transducer 2 Disconnect the transducer from the
InnoSight Ultrasound System see Ultrasound Transmission Gels on page 11 Follow the label instructions for preparation, temperature, solution strength and duration of contact Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device If a pre-mixed solution is used, be sure to observe the solution expiration date 3 Wipe or spray the transducer, cable, strain relief, and connector with the disinfectant, following the disinfectant label instructions
InnoSight Ultrasound System Do not use hand sanitizing gels Do not apply the transducer gel until you are ready to perform the procedure Transducers should not be left soaking in gel Gels listed here are recommended because of their chemical compatibility with product materials Some recommended gels include: Aquasonic 1 Aquasonic Clear Carbogel-ULT ECG Gel (Nicom) Nemidon Gel Scan Compatible Disinfectants and Cleaning Solutions The following table lists the disinfectants and cleaning solutions compatibl
InnoSight Ultrasound System Disinfectants and Cleaning Solutions Table Legend Country of Origin AU CA DE ES FR P U US Disinfectant Type Australia Canada Germany Spain France apan United ingdom United States Compatibility CL Cleaner HLD High-level disinfectant ILD Intermediate-level disinfectant LLD Low-level disinfectant S Sterilant T (Transducer) C Approved for use on the cable and connector (never immerse or soak a connector) T Approved for use on the transducer N Not approved for use C (Cable, co
InnoSight Ultrasound System Solution Country of Qualified Use Origin Active Ingredient Disinfectant Compatibility Type Cidex PAE 14 FR Soaka Glutaraldehyde HLD, S T a Cidex Plus US Soak Glutaraldehyde HLD, S T Cleanisept Wipes DE Spray/Wipe QUAT LLD, ILD T Clorox Healthcare Bleach Germicidal Cleaner US Spray/Wipe Sodium Hypochlorite LLD, ILD T Clorox Healthcare Hydrogen Peroxide Cleaner US Disinfectants Spray/Wipe Hydrogen Peroxide LLD, ILD T Combi-Instruments-N FR Soaka
InnoSight Ultrasound System Solution Country of Qualified Use Origin neodisher endo DIS active DE Olympic Peracetic Acid U Omnicide 14NS Omnicide 2 US US Active Ingredient Disinfectant Compatibility Type Soaka Peracetic Acid HLD T AER Peracetic Acid HLD N Soak a Glutaraldehyde HLD, S T Soak a Glutaraldehyde HLD, S T a Ortho-phthalaldehyde HLD T OPAL AU Soak Opticide3 US Spray/Wipe Alcohol, QUAT LLD, ILD T Oxivir (all types) US Wipe Hydrogen Peroxide LLD, ILD T
InnoSight Ultrasound System Solution Country of Qualified Use Origin Active Ingredient Disinfectant Compatibility Type US Reprocessor (S) Hydrogen Peroxide S N TD- US TD-1 Reprocessor Glutaraldehyde HLD, S N Tristel Duo U Foam/Wipe Chlorine Dioxide HLD T Tristel Fuse for Instruments U Stella System Chlorine Dioxide HLD T Tristel Multi-Shot U Soaka Chlorine Dioxide HLD T Tristel Sporicidal Wipes U Wipe Chlorine Dioxide HLD T Tristel Trio Trace U Pre-clean wipe, sporic
11 11 System Maintenance Maintenance should be performed regularly and as needed Cleaning the System The system and peripherals are medical electrical equipments and require thorough cleaning If exposed to constant and excessive environmental dust and humidity, both performance and reliability of these devices will be suffered Clean the power adapter, ventilation slots, all connection ports/sockets and the touch screen regularly or whenever you observe dust or other particles For information on transduc
InnoSight Ultrasound System Cleaning Cleaning solutions for Disinfectants for system surfaces, Disinfectants for cart surfaces solutions for monitor screens including the touch screen all surfaces Mild soap solution Cleaners designed for touch screens Purified water Mild soap solution isopropyl alcohol (IPA) ethanol alcohol isopropyl alcohol (IPA) ethanol alcohol Ta le 7 Disinfectants and cleaning solutions for system/system cart surfaces If blood or other infectious material comes in contact with a tr
InnoSight Ultrasound System Cleaning the Power Adapter Do not immerse the power adapter eep moisture and liquid away from the power adapter Do not spill or spray liquid on the adapter 1 Wipe the power adapter with a dry cloth 2 If spot cleaning is necessary, wipe with a cloth dampened with soapy water If disinfection is necessary, wipe with an alcohol-moistened cloth 3 Remove any solid matter with a cotton swab or toothpick to ensure that solids are not pushed into the adapter 4 Wipe off any excess
InnoSight Ultrasound System Symptom Possible cause and corrective action The system can’t read/ write data from the USB storage device No image or abnormal display on the system screen Image Artifacts occur on the imaging screen Software installation failed Two USB storage devices are connected to the system at the same time.* » Ensure the USB storage device you wish to read/write data from is connected to the system through the USB 3 port The USB storage device is damaged.
InnoSight Ultrasound System Symptom Possible cause and corrective action No audio or noise comes from the system speakers The system is muted. Open the system tool menu and adjust the volume The speakers are damaged. » Contact technical support The HDMI cable/port is damaged. HDMI does not function » Use another HDMI cable for connection » Connect the system to a computer through HDMI connection for inspection Bluetooth connection failed DICOM connection failed The Bluetooth settings are not correct.
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12 12 Appendix Appendix A: Specifications Specifications are subject to change without prior notice System Item Specifications Form factor Tablet Weight 42 lb (2 46 kg): With the rotating stand and 4 locator pins Length 12 Width (319 6 mm) Dimensions Height (Thickness) 9 (223 2 mm) 12 2 24 (31 mm): Without the rotating stand ( 2 6 mm): With the rotating stand Without 4 locator pins (62 3 mm): With the rotating stand and 4 locator pins Materials Plastic, metal, rubber Color White Speaker
InnoSight Ultrasound System Item Specifications Power adapter Input: AC 1 24 V, 6 Hz, Max 1 A Output: 19Vdc, 3 4A Transducer S4-2, L12-4, C6-2, C9-4v System cart Support Tilt and Swivel oints, Height Adjustment, Instant dock and undock function Accessories Storage/transport Temperature: -2 6 C Humidity 2 9 RH Air pressure 1 6 hPa Environmental operating conditions Temperature: 1 Humidity: 2 Air pressure: Product life 4 C RH, no condensation 1 6 hPa years Battery Model: QIC3 Battery type (non-remo
InnoSight Ultrasound System Item Rate performance Remark Storage temperature and humidity range -2 -2 -2 -2 Within 1 year, 4 to RH Within 6 months, 4 to RH Within 1 month, 4 to RH Within 1 week, 4 to RH Power consumption Normal mode Sleep mode Shutdown mode 3 C 4 C 4 C C 62 A 12 A 42 A Transducer Transducer Elements Descriptions Applications S4-2 64 Phased array transducer with a maximum depth of 2 mm and a user-controllable field-of-view Adult abdominal OB/GYN Cardiac Abdominal vascular Fe
InnoSight Ultrasound System Item Specifications Water resistant level IP21 Efficiency Eff (av) Safety Approved according to IEC 6 6 1-1 Edition 3 EMC IEC 6 6 1-1-2, IEC 612 4-3, EN Protection OVP (Over Voltage Protection), SCP (Short Circuit Protection), OCP (Over Current Protection) Features 11 Class B Highest output power on the market of wall plug adapters Exchangeable AC-plugs for universal use Suitable to power up medical systems up to BF class Appendix B: Connectivity and Security Intr
InnoSight Ultrasound System Port for DICOM communication (typically port 1 4, 2 62 or 11112 to specify the port, on the system’s imaging screen, touch Menu >Settings > DICOM Port for HTTP web servers (not supported by the system) Anti-virus software is not installed on the system Information Flow Worklist query InnoSight Worklist server Worklist response DICOM storage/Echo request PACS server Echo response Figure 43 Information flow Read the system’s DICOM Conformance Statement for detailed instr
InnoSight Ultrasound System IT Network failure Impact on the equipment Hazard Unable to transmit exam data to a PACS Delay of Delay of transmission to a diagnosis PACS IT network becomes unstable Incorrect data transmitted to a PACS Unable to retrieve order data from an MWL server Delay of retrieving order data from an MWL server Incorrect data from a MWL server Attack via network Firewall has broken down Infection by computer virus System countermeasures Exam data is stored in the system’s internal s
InnoSight Ultrasound System Appendix C: System Acoustic Output Default Tables C6-2 Transducer Exam Type Preset Mode TI Label Default TI Default MI 2D Color CPA M Abdominal Abdomen PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M Fetal OB PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) P69 92- 4 , EN, 16/12/ 6 12 Appendix Appendix C: System Acoustic Output Default Tables 133
InnoSight Ultrasound System Exam Type Preset Mode TI Label Default TI Default MI 2D Color CPA M Renal PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) Urology 2D Color CPA M Urology PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M GYN GYN PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 134 Appendix C: System Acoustic Output Default Tables 12 Appendix P69 92- 4 , EN, 16/12/ 6
InnoSight Ultrasound System L12-4 Transducer Exam Type Preset Mode TI Label Default TI Default MI 2D Color CPA M Carotid PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M Cardiac Vascular Arterial PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M Venous PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) P69 92- 4 , EN, 16/12/ 6 12 Appendix Appendix C: System Acoustic Output Default Tables 13
InnoSight Ultrasound System Exam Type Preset Mode TI Label Default TI Default MI 2D Color CPA M Thyroid PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) Small Organ (breast, thyroid) 2D Color CPA M Breast PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M Abdominal Bowel PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M Muscle MS PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 136 Ap
InnoSight Ultrasound System Exam Type Preset Mode TI Label Default TI Default MI TI Label Default TI Default MI 2D Color CPA M Nerve Nerve PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) S4-2 Transducer Exam Type Preset Mode 2D Color CPA M Cardiac Cardiac PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) P69 92- 4 , EN, 16/12/ 6 12 Appendix Appendix C: System Acoustic Output Default Tables 13
InnoSight Ultrasound System C9-4v Transducer Exam Type Preset Mode TI Label Default TI Default MI 2D Color CPA M OB PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) Trans-vaginal Cardiac 2D Color CPA M GYN PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 2D Color CPA M Trans-rectal Prostate PW THI Color THI CPA THI M 2D Color PW (Triplex) 2D CPA PW (Triplex) 13 Appendix C: System Acoustic Output Default Tables 12 Appendix P69 92- 4 , EN, 16/12/ 6
InnoSight Ultrasound System Appendix D: Acoustic Output Reporting Tables for Track 3 We follow Track 3 of the FDA’s information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers All table entries have been obtained at the same operating conditions that give rise to the maximum index value Due to the complexities of the system user interface, it may be difficult to exactly replicate the declared condition For more information, contact Philips Definition of Terms
InnoSight Ultrasound System P: Output power is the time-average power radiated by an ultrasonic transducer into an approximately free field under specified conditions in a specified medium, preferably water P : Attenuated output power is the value of the acoustic output power after attenuation, at a specified distance from the transducer, and given by p p10( awf/1 ) pi: Pulse-pressure-squared integral is the time integral of the square of the instantaneous acoustic pressure at a particular point in an acou
InnoSight Ultrasound System Acoustic Output Tables for InnoSight Transducers Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in 2D Mode TIS Index label MI Global maximum index value Associated acoustic parameter 119 Non-scan Aaprt 1cm 2 Aaprt > 1cm # (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # # # (microsec) PRF (Hz) MImax (b) 4 PD Ipa 3 2 1 3
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in THI Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 16 # 3 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) (microsec) PRF (Hz) MImax # # # PD Ipa 3 (b) 5 29 Y (cm) Focal length # 24 (cm) pr PIImax Othe
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in 2D+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 1 3 # 70 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) 2 49 # 2 49 # # # # (cm) 22 # # # # Y (cm) 13 # # # # PRF (Hz) 5000 (MPa) 3 MIma
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in THI+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 166 # 95 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) 2 49 # 2 49 # # # # (cm) 22 # # # # Y (cm) 13 # # # # PRF (Hz) 5000 MImax # #
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in 2D+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) 4 z1 (cm) 6 zbp (cm) 2 9 zsp (cm) z PII 3max (cm) deq(zsp) (cm) # 3 1 3 1 # (cm) # # 22 22 # Y (cm) # # 13 13 # (Hz) MImax 2 # PRF Ipa 3 2 # (m
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in THI+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter Pr 3 (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) z1 (cm) zbp (cm) zsp (cm) z PII 3max (cm) deq(zsp) (cm) fc 3 1 # # 64 (b) 54 # # # 3 1 3 1 # (cm) # # 22 22 # Y (cm) # # 13 13 # (Hz) 250 (MPa) 4 MImax # Aaprt > 1cm TIC 69 PRF Ipa 3
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C6-2 Transducer InnoSight Diagnostic Ultrasound System in PW Doppler Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # # # # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) 11 1 z1 (cm) 4 zbp (cm) 3 zsp (cm) z PII 3max (cm) deq(zsp) (cm) 2 # # # 2 2 # (cm) # # 2 2 # Y (cm) # # 13 13 # PRF (Hz) 13 MImax 52 16 1 Ip
InnoSight Ultrasound System Acoustic Output Reporting table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in 2D Mode TIS Index label MI Global maximum index value Associated acoustic parameter 11 Non-scan Aaprt 1cm 2 Aaprt > 1cm # (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # # # # # (cm) 6 # # # # Y (cm) 4 # # # # (Hz) MImax # 299 66 PRF Ipa 3 (b) # (microsec
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in THI Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 13 # 6 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # 3 # # # # (cm) 6 # # # # Y (cm) 4 # # # # (Hz) MImax # # PRF Ipa 3 (b) 1 46 (micr
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in 2D+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter 1 3 Non-scan Aaprt 1cm 22 # 39 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) (microsec) PRF (Hz) MImax # # # PD Ipa 3 (b) 21 5 5 3 Y (cm) Focal length # # (cm)
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in THI+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 241 # 39 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) (microsec) PRF (Hz) MImax # # # PD Ipa 3 (b) 21 5 5 3 Y (cm) Focal length # 226 (cm)
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in 2D+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # 126 # 41 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # 6 # 6 # 6 # # 1 # 1 # Y (cm) # 4 # 4 # (Hz) MImax 41 (cm) PRF Ipa 3 42 1 9
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in THI+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter # Non-scan Aaprt 1cm 231 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # 6 # 6 # 6 # # 1 # 1 # Y (cm) # 4 # 4 # (Hz) MImax # (cm) PRF Ipa 3 4 2 4 (micros
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the L12-4 Transducer InnoSight Diagnostic Ultrasound System in PW Doppler Mode TIS Index label MI Global maximum index value Associated acoustic parameter # Non-scan Aaprt 1cm 2 4 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # 5 16 # # 5 # 5 # (cm) # 41 # 41 # Y (cm) # 4 # 4 # (Hz) 5000 (MPa) 4 MImax 16 6
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in 2D Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 33 # 155 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # # # # (cm) 1 63 # # # # Y (cm) 12 # # # # (Hz) MImax # 43 23 PRF Ipa 3 # # (mic
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in THI Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 2 16 # 269 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # # # # (cm) 1 63 # # # # Y (cm) 12 # # # # (Hz) MImax # 44 2 1 PRF Ipa 3 # #
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in 2D+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter 3 Non-scan Aaprt 1cm 2 Aaprt > 1cm # (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) 4 2 44 # # 2 44 # # # # (cm) 1 63 # # # # Y (cm) 12 # # # # PRF (Hz) 5000 MImax # # 1
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in THI+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm 46 # 63 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) 2 46 # 2 46 # # # # (cm) 1 63 # # # # Y (cm) 12 # # # # PRF (Hz) 6000 MImax # #
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in 2D+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) z1 (cm) 5 zbp (cm) 2 36 zsp (cm) z PII 3max (cm) deq(zsp) (cm) 2 # 2 46 2 46 # (cm) # # 1 63 1 63 # Y (cm) # # 12 12 # (Hz) MImax # # PRF Ipa 3 3
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in THI+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) z1 (cm) 4 zbp (cm) 2 36 zsp (cm) z PII 3max (cm) deq(zsp) (cm) 26 64 2 41 # # 2 41 2 41 # (cm) # # 1 63 1 63 # Y (cm) # # 12 12 # PRF (Hz) 250 (M
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in PW Doppler Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) 11 6 z1 (cm) 49 zbp (cm) 2 36 zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # 2 44 2 44 # (cm) # # 1 63 1 63 # Y (cm) # # 12 12 # (Hz) MImax 33 #
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the S4-2 Transducer InnoSight Diagnostic Ultrasound System in CW Doppler Mode TIS Index label MI Global maximum index value Associated acoustic parameter Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) 3 1 z1 (cm) 4 zbp (cm) 2 36 zsp (cm) z PII 3max (cm) deq(zsp) (cm) 22 # # 22 22 # (cm) # # 1 63 1 63 # Y (cm) # # 12 12 # (Hz) 4000 (MPa) 6
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C9-4v Transducer InnoSight Diagnostic Ultrasound System in 2D Mode TIS Index label MI Scan Global maximum index value Associated acoustic parameter Aaprt 1cm 66 # 1 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) (microsec) PRF (Hz) MImax # # # PD Ipa 3 (b) 2 3 3 1 Y (cm) Focal length # # (cm) pr PIImax Othe
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C9-4v Transducer InnoSight Diagnostic Ultrasound System in 2D+Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter 99 Non-scan Aaprt 1cm 39 # 2 1 # 2 Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) 66 (microsec) PRF (Hz) 4000 (MPa) 3 MImax # # # PD Ipa 3 (b) 2 66 # # # # 1 #
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C9-4v Transducer InnoSight Diagnostic Ultrasound System in THI-Color Mode TIS Index label MI Global maximum index value Associated acoustic parameter 1 1 3 Non-scan Aaprt 1cm 2 Aaprt > 1cm # (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) # z1 (cm) # zbp (cm) # zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # # # (microsec) PRF (Hz) MImax (b) 1 99 PD Ipa 3 4 66 66 # # # # 1 # # # # #
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C9-4v Transducer InnoSight Diagnostic Ultrasound System in 2D+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter 129 Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) z1 (cm) 23 zbp (cm) 1 9 zsp (cm) z PII 3max (cm) deq(zsp) (cm) 32 # # 4 4 # (cm) # # 22 22 # Y (cm) # # (Hz) MImax # 21 PRF Ipa 3 29 23 (mi
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C9-4v Transducer InnoSight Diagnostic Ultrasound System in THI+M-Mode TIS Index label MI Global maximum index value Associated acoustic parameter 12 Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) 33 z1 (cm) 24 zbp (cm) 1 9 zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # 4 4 # (cm) # # 22 22 # Y (cm) # # (Hz) MImax # 22 PRF Ipa 3 33 24 (mic
InnoSight Ultrasound System Acoustic Output Reporting Table for Track 3 for the C9-4v Transducer InnoSight Diagnostic Ultrasound System in PW Doppler Mode TIS Index label MI Global maximum index value Associated acoustic parameter 122 Non-scan Aaprt 1cm # # # # 2 TIB Aaprt > 1cm (MPa) W0 (mW) Min of W 3(z1), ITA 3(z1) (mW) 4 z1 (cm) 2 zbp (cm) 1 9 zsp (cm) z PII 3max (cm) deq(zsp) (cm) # # 63 63 # (cm) # # 22 22 # Y (cm) # # (Hz) MImax 11 # PRF Ipa 3 3 6
InnoSight Ultrasound System Appendix D: FCC Statement Federal Communications Commission (FCC) Statement 1 21 You are cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment 1 1 (b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 1 of the FCC rules These limits are designed to provide reasonable protection against harmful interference in a
InnoSight Ultrasound System This device bearing the CE marking is in compliance with the essential requirements and other relevant provisions of Directive 2 4/1 /EC, 2 14/ 3/EU, 2 11/6 /EU, 2 12/19/EU and 93/42/EEC This device complies with the following harmonized European standards: EMC: EN 22, EN 24 Radio: EN3 32 , EN3 1 93, EN3 14 9-1, EN3 14 9-1 , EN62311 Medical: IEC 6 6 1-1, EN6 6 1-1-2, IEC 6 6 1-1-6, IEC 6 6 1-2-3 , IEC 623 4, EN ISO1 993-1, EN ISO1 993- , EN ISO1 993-1 , EN ISO 149 1 ROHS: EN 1
InnoSight Ultrasound System P69 92- 4 , EN, 16/12/ 6 12 Appendix Appendix D: FCC Statement 171
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