Bard Site-Rite 8 Instructions For Use Manual
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Bard Site-Rite 8 Instructions For Use Manual

Ultrasound system
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Summary of Contents for Bard Site-Rite 8

  • Page 1 Instructions for Use...
  • Page 2 SYMBOLS Consult Instructions for Use Temperature Limitation Humidity Limitation Manufacturer Keep Dry Type BF Applied Part Caution: Federal (U.S.A.) law Do not dispose with ordinary restricts this device to sale by municipal waste or on the order of a physician Federal Communications IPX1 Drip Proof Equipment...

  • Page 3: Table Of Contents

    Table of Contents OVERVIEW ..................................4 1.1. Site~Rite® 8 Ultrasound System Device Description ......................4 1.2. Needle Guidance (if enabled) .............................. 4 1.2.1. Cue™ Needle Tracking System Description ......................4 1.2.2. Pinpoint™ GT Needle Technology Description ......................4 1.3. Site~Rite® Ultrasound System Indications for Use ......................5 1.4.
  • Page 4 7.1.7. Battery Information ..............................17 7.2. Catheter Icons ................................... 18 7.3. Main Toolbar ..................................18 7.3.1. Depth ..................................18 7.3.2. Gain ..................................18 7.3.3. Freeze ..................................18 7.3.4. Pinpoint™ GT Needle Technology Mode (if enabled) ....................18 7.3.5. SHERLOCK 3CG™ TCS Mode (if enabled) ......................18 7.3.6.
  • Page 5 11.4.3. DICOM (if enabled) ..............................49 11.4.4. DICOM Conformance Statement ..........................50 11.4.5. Bluetooth™ Wireless Technology (if enabled) ......................50 11.5. System Information ..............................50 PATIENT INFORMATION ..............................51 CLINICIAN PRESETS ............................... 52 ACCESSING SAVED PATIENT IMAGES.......................... 52 OPERATING THE SITE~RITE® 8 ULTRASOUND SYSTEM .................... 54 15.1.

  • Page 6: Overview

    1. OVERVIEW 1.1. Site~Rite® 8 Ultrasound System Device Description ® The Site~Rite 8 Ultrasound System is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled). 1.2. Needle Guidance (if enabled) ®...

  • Page 7: Site~Rite® Ultrasound System Indications For Use

    1.3. Site~Rite® Ultrasound System Indications for Use ® The Site~Rite 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: • Pediatric • Peripheral Vessel and Vascular Access • Small Organ (breast, thyroid, parathyroid, testicles) •...

  • Page 8: Site~Rite® 8 Ultrasound System Compatible Accessories

    1.7. Site~Rite® 8 Ultrasound System Compatible Accessories ® The Site~Rite 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is compatible with the following accessories: • Cue™ Activator mounting arm • Pinpoint™ GT Needle Guides • ®...

  • Page 9: Warnings And Cautions

    8 Ultrasound System and may result in injury or equipment damage: • Opening or servicing any component by anyone other than service personnel authorized by Bard Access Systems. • Removing system labels by anyone other than service personnel authorized by Bard Access Systems.

  • Page 10: Cue™ Needle Tracking System Warnings (If Enabled)

    Caution: Do not force connections; improper installation may damage the connector or system. Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may damage the device. Caution: Use only approved or recommended cleaners or disinfectants to avoid damaging the device.
  • Page 11 Some commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to the US FDA alert titled: “Medical Alert: Allergic Reactions to Latex –Containing Medical Devices,” issued March 29, 1991. Bard Access Systems distributes sterile probe covers and needle-guide kits that are not made with natural rubber latex.

  • Page 12: Cue™ Needle Tracking System Cautions (If Enabled)

    2.5. Cue™ Needle Tracking System Cautions (if enabled) Caution: Keep the needle and any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, Cue ™ Activator, electronics, metal bed rails, etc. at least 3 feet away from probe when calibrating. Failure to do so may impact the accuracy of needle tracking. Caution: Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference which could affect the performance of this device.

  • Page 13: Physical Features

    3. PHYSICAL FEATURES 3.1. Console Features Power Switch USB 3.0 USB 2.0 (3 ports) Ethernet HDMI video out Kensington Slot (for security cable) Power Connection Probe Holder Slot Mounting Plate Probe Connector (if applicable) Battery Switch Cover For installation of approved mounting accessories, please see the appropriate assembly instructions. Caution: When attaching the system to the roll stand or kickstand, do not over tighten the screws;...

  • Page 14: Compatible Probes

    3.2. Compatible Probes Linear 20mm Cue™ Needle Tracking Linear 20mm Pinpoint™ GT Needle Linear 32mm Probe System Probe Technology Probe 3.3. Connecting the Ultrasound Probe (if applicable) To connect the probe: Align the probe connector and gently insert the probe into the console. Note: If the EC204 error appears, connect/reconnect the probe and restart the system.

  • Page 15: Led Status Indicators

    3.4. LED Status Indicators The LED icons, shown below, are located along the top of the display. WiFi Ethernet Power Green indicates WiFi is enabled Green indicates the Ethernet Green indicates the unit is on. (if enabled). connection is active (if enabled). Bluetooth™...

  • Page 16: Power Options

    5. POWER OPTIONS Close power menu and return to the 5.1. Power On previous screen. To turn on the system, press the power switch on the upper left side of the unit. Power off 5.2. Power Menu The power menu can be accessed the following ways: Restart To access the power menu, press the power switch on the side of the device.

  • Page 17: Probe

    6.3. Probe The probe controls can be used to navigate procedurally applicable buttons. Linear 32mm Probe Cursor Up Cursor Right Press to move cursor up. Press to move cursor right. Cursor Left Press to move cursor left. Cursor Down Press to select the Press to move cursor current control.

  • Page 18: Main Ultrasound Screen

    7. MAIN ULTRASOUND SCREEN After starting the system, the main ultrasound screen will appear. Information Bar Catheter Icons Image Depth Scale Depth Markers Cue™ Needle Tracking System Activator Icon Main Toolbar (if enabled - see Section 9) An explanation of the various parts of the main ultrasound screen is provided below. 7.1.

  • Page 19: Time

    7.1.1. Time The time is displayed in 24-hour format, as follows: hour:minute:second 7.1.2. Date The date is displayed in the following format: year-month-day. 7.1.3. Patient Information To enter patient information, select the button shown. The patient information screen will appear, allowing you to enter information. For instructions on this process, refer to Section 12.

  • Page 20: Catheter Icons

    7.2. Catheter Icons Catheter Icons Toggles through available catheter icon sizes. The catheter icons are displayed in proportion to the vessel image at a selected depth. Icons assist clinicians in determining the appropriate catheter size for the vessel being imaged. 7.3.

  • Page 21: Depth Markers And Image Depth Scale

    7.4. Depth Markers and Image Depth Scale Image Depth Scale in cm. Depth Markers Displays centered depth markers in 0.5cm increments. To enable, refer to Section 11.1. 7.5. Probe Orientation The probe orientation icon corresponds to the button pad on the ultrasound probe. ®...

  • Page 22: Freeze Mode

    8. FREEZE MODE Access freeze mode by pressing the freeze button on the main ultrasound screen. The following screen will appear. Date/Time when image was frozen. Catheter Icons Toggles through available catheter icon sizes. 3CG™ HERLOCK TCS Mode Switches to 3CG™...
  • Page 23 Catheter Icons Toggles through available catheter icon sizes Select desired catheter icon size. Vessel Measurement Indicator This icon indicates whether the vessel Vessel Occupancy Percentage occupancy is calculated by Diameter or Area. This can be set in the This is the user-defined vessel occupancy percentage rule.
  • Page 24 To manually resize the Vessel Occupancy Circle to the target vessel, align the top Align with top of vessel. middle of the Vessel Occupancy Circle with the top middle of the vessel by pressing and holding the middle of the icon and dragging it to the desired location.

  • Page 25: Cue™ Needle Tracking System Mode (If Enabled)

    9. CUE™ NEEDLE TRACKING SYSTEM MODE (if enabled) 9.1. Enabling Cue™ Needle Tracking System Ensure the Cue™ Probe is attached (see Section 3.2). Turn on the system and ensure the ultrasound system is scanning. The Cue™ Activator icon will appear, as shown below, when the Cue™ Probe is attached. Turn on the system and ensure the system images.

  • Page 26: Cue™ Needle Tracking System Home Screen

    9.3. Cue™ Needle Tracking System Home Screen Current selected needle Exit Cue™ Needle information. Tracking System mode. Catheter size of current selected needle. Probe face overlay. Performance Indicator Help Select when Performance Indicator is low for tips on how to improve the Performance Indicator.
  • Page 27 In-Plane Insertion When the needle is well aligned with the probe face, the needle graphic is green. Probe View Probe Face Overlay View – Well Aligned When the needle is not aligned with the probe face, the needle graphic is red. Probe View Probe Face Overlay View –...

  • Page 28: Performance Indicator

    9.3.2. Performance Indicator The Performance Indicator measures the quality of the magnetic environment around the probe. Stray magnetic fields can inhibit the probe’s ability to detect an activated needle. More bars indicate a “cleaner” magnetic environment for detecting an activated needle. Performance Indicator Indication: Low magnetic fields are present.

  • Page 29: Cue™ Needle Tracking System Overlay

    9.4. Cue™ Needle Tracking System Overlay 9.4.1. Out-of-Plane Insertion Actual View On-Screen View Note: Adjusting the angle of the needle up or down or changing the distance between the needle and probe will change the position of the Intersection Window. A flat angle is required for shallow insertion.
  • Page 30 Actual View On-Screen View Needle Shaft Needle Tip Needle Intersection Window Trajectory Ultrasound Beam ® Site~Rite 8 Ultrasound System Page 28...

  • Page 31: In-Plane Insertion

    9.4.2. In-Plane Insertion Actual View On-Screen View Needle Shaft Needle Shaft Needle Needle Trajectory Needle Tip Needle Trajectory Ultrasound Beam Needle Shaft Needle Needle Shaft Needle Needle Trajectory Needle Tip Trajectory Ultrasound Beam ® Site~Rite 8 Ultrasound System Page 29...

  • Page 32: Pinpoint™ Gt Needle Technology Mode (If Enabled)

    10. PINPOINT™ GT NEEDLE TECHNOLOGY MODE (if enabled) 10.1. Pinpoint™ GT Needle Technology Home Screen. Access Pinpoint™ GT Needle Technology Mode by pressing the Pinpoint™ GT Needle Technology button on the main ultrasound screen. The following screen will appear: The calibration status of the Pinpoint Calibration Status Calibration Status Icon Border...

  • Page 33: Pinpoint™ Gt Needle Technology Calibration

    10.2. Pinpoint™ GT Needle Technology Calibration Selecting this button will calibrate Pinpoint™ Technology. The button also indicates the status of calibration. A calibration step is required to establish a baseline before bringing the needle close to the probe. Calibration is only required prior to inserting the needle into the patient.

  • Page 34: Pinpoint™ Gt Needle Technology Needle Tracking

    10.3. Pinpoint™ GT Needle Technology Needle Tracking Once Pinpoint™ GT Needle Technology has finished calibrating, the system is ready to begin tracking Pinpoint™ GT Needle Technology compatible needles. Calibration Status Icon Calibration Status Border Once Pinpoint™ GT Needle Technology is This border indicates the calibrated, the status icon calibration status of...

  • Page 35: Pinpoint™ Gt Needle Technology Freeze Mode

    10.4. Pinpoint™ GT Needle Technology Freeze Mode Access Pinpoint™ GT Needle Technology freeze mode by pressing the freeze button. The following screen will appear: Pinpoint™ GT Needle Technology Virtual Needle Image Virtual needle image of the Pinpoint™ GT Safety Introducer Needle. Date/Time when image was frozen.

  • Page 36: Pinpoint™ Gt Needle Technology Errors

    10.5. Pinpoint™ GT Needle Technology Errors Pinpoint™ GT Needle Technology Error. Refer to Section 16.3, Troubleshooting. Error Icon and Number This icon indicates that a Pinpoint™ GT Needle Technology malfunction has occurred. Refer to Section 16.3, Troubleshooting, for addressing errors. Calibration Status Border This border indicates the...

  • Page 37: Pinpoint™ Gt Needle Technology Virtual Needle Image - Out-Of-Plane Needle Insertion

    10.6. Pinpoint™ GT Needle Technology Virtual Needle Image – Out-of-Plane Needle Insertion Actual View On-Screen View Note: Adjusting the angle of the needle up or down will change the position of the ultrasound beam point of intersection circle. A flat angle is required for shallow insertion.
  • Page 38 When the needle passes through the Point of Intersection Circle, the circle changes color from violet to green. Any portion of the needle that lies beyond the Point of Intersection Circle changes color from yellow to violet. Actual View On-Screen View Needle Shaft Point of Intersection...

  • Page 39: Pinpoint™ Gt Needle Technology Virtual Needle Image - In Plane Needle Insertion

    10.7. Pinpoint™ GT Needle Technology Virtual Needle Image – In Plane Needle Insertion Actual View On-Screen View Needle Shaft Needle Tip Needle Shaft Needle Trajectory Needle Tip Needle Trajectory Ultrasound Beam Needle Shaft Needle Trajectory Needle Tip Needle Shaft Needle Trajectory Needle Tip Ultrasound...
  • Page 40 When the needle is positioned for In-Plane insertion, a rectangular box representing the probe face appears on the bottom right side of the screen. Since the needle is inserted “in plane” to the ultrasound bean, the Pinpoint™ GT Needle Technology Virtual Needle Image does not show a Point of Intersection Circle. In-Plane Box Note: When the needle is positioned back to an Out-of-Plane placement, the In-Plane box is not displayed and...
  • Page 41 Well Aligned – In-Plane Box and Needle Trajectory are Green Probe View Ultrasound Image In-Plane Box View Needle Needle Trajectory Shaft Misaligned – In-Plane Box and Needle Trajectory are Violet Probe View Ultrasound Image In-Plane Box View Needle Needle Trajectory Shaft ®...

  • Page 42: System Settings

    11. SYSTEM SETTINGS To access the system settings, press the ‘Settings’ button on the main ultrasound screen. The Settings window consists of several tabs: Name of Clinician (if Power Menu entered). See Clinician Opens the Power Menu. Presets, Section 13 Returns to the previous screen See Section 5.2 System Information...

  • Page 43: Cue™ Needle Tracking System Settings (If Enabled)

    11.2. Cue™ Needle Tracking System Settings (if enabled) To access the Cue™ Needle Tracking System settings, click on the ‘Cue™ Needle Tracking System’ settings tab at the top of the settings screen. The following screen will appear: Launches the Toggles the Cue™...

  • Page 44: Calibration

    11.2.1. Calibration Calibration may be required when the Performance Indicator (see Section 9.3.2) measures a poor magnetic environment. To determine if calibration is necessary, hold the Cue™ Probe Stationary in the air away from all metal, magnetic, and electronic devices. If the Performance Indicator improves, calibration is not required. For tips on how to improve the Performance Indicator when calibration is not required, press the ‘Performance Indicator Help’...

  • Page 45: General Settings

    Some features may need additional hardware to function. To add a feature using the activation key: Type in the Bard provided activation key into the appropriate field corresponding to the feature. Press the unlock button. A correct key will result in a green check mark and activate the feature. An incorrect key will result in a red X.

  • Page 46: System Password

    11.3.2. System Password To configure password protection, enable the password option in the general settings tab. The first-time password protection is enabled, the system will display a prompt to create an administrator password. The administrator password will be used to make any future configuration changes to the system password. If the administrator password is forgotten, contact customer service for a temporary password.
  • Page 47 11.3.2.1. Pin Password Settings Exit and return to password Enter any numeric configuration screen password between 1 without saving. and 10 digits. Enable and set the number of days until the PIN expires. Save password and return to password configuration screen. 11.3.2.2.

  • Page 48: Patient/Clinician Backup/Restore

    11.3.3. Patient/Clinician Backup/Restore To backup and restore patient and clinician data, select the ‘Backup/Restore’ button in the General Settings Tab (the admin password is required for access). Backup patient data files. Select drop-down to select and restore from a previous backup file.

  • Page 49: Wifi Networks

    11.4.1. WiFi Networks Select the ‘WiFi Network’ button to access and connect to WiFi networks. See Sections 24 and 25 for technical specifications. WiFi signal strength. Edit WiFi network settings. Select to connect to WiFi network. Delete WiFi network settings. Add WiFi network.

  • Page 50: Configure Network Settings

    Add a visible WiFi network or select “Add WiFi Network” button to add a custom or hidden WiFi network. Add visible WiFi network. Add WiFi network. Step 5 Fill in the required information. After the information is filled in, select Step 6 The system should now be connected to the WiFi network.

  • Page 51: Dicom (If Enabled)

    11.4.3. DICOM (if enabled) To configure DICOM settings, press the ‘DICOM Settings’ button. Fill in the information to configure the PACS server: Sends a standardized DICOM ECHO request to the specified PACS  system. A green indicates success and a red ‘X’ indicates a failure. Shift / Display additional Characters.

  • Page 52: Dicom Conformance Statement

    11.4.4. DICOM Conformance Statement Files are formatted according to Digital Imaging and Communications in Medicine. The DICOM conformance statement is available upon request. Call Customer Service at 1-800-545-0890. 11.4.5. Bluetooth™ Wireless Technology (if enabled) To pair a Bluetooth™ Wireless Technology device and adjust Bluetooth™ Wireless Technology settings, press the Bluetooth™...

  • Page 53: Patient Information

    12. PATIENT INFORMATION Instructions to enter patient information into the Site~Rite® 8 Ultrasound System are as follows: Select the ‘Patient Information’ button. The following options will appear: Allows the user to edit existing patient information. These changes will be applied to previously saved images for the Add new patient.

  • Page 54: Clinician Presets

    13. CLINICIAN PRESETS The Site~Rite® 8 Ultrasound System allows individual clinicians to retain their unique settings. Clinician Presets will automatically retain the following settings for each clinician name: • Ultrasound image depth • Ultrasound image gain • All settings in the ultrasound settings tab (see Section 11.1) •...
  • Page 55 After selecting the patients, select all images to be managed. Toggle between .jpg files and .log files. Select all / deselect all of the images for the patient listed. To select or deselect an image, touch the gray border of the image. To preview an image, Image List touch the center of the...

  • Page 56: Operating The Site~Rite® 8 Ultrasound System

    Some Commercially available probe covers contain latex. Natural rubber latex may cause allergic reactions. Refer to the US FDA alert titled: “Medical Alert: Allergic Reactions to Latex –Containing Medical Devices,” issued March 29, 1991. Bard Access Systems distributes sterile probe covers and needle-guide kits that are not made with natural rubber latex.

  • Page 57: Access Using The Cue™ Needle Tracking System (If Enabled)

    15.1. Access using the Cue™ Needle Tracking System (if enabled) Prepare the Site~Rite® Ultrasound System: Verify the battery charge is sufficient for the procedure; otherwise connect the power adapter to the Site~Rite® 8 Ultrasound System Enter the patient information as needed Position the patient and perform the ultrasound assessment Prepare the sterile field: Ensure all metallic objects are removed from the surrounding location (at least 4 inches away).
  • Page 58 Proceed with insertion – watch needle advancement onscreen. The solid green lines represent the needle shaft and tip. The green square represents the area where the needle will intersect the ultrasound plane During advancement, maintain the Intersection Window centered with the intended target structure When the solid green lines reach the Intersection Window, it means the needle has intersected the plane of the ultrasound beam within the Intersection window.

  • Page 59: Access Using Pinpoint™ Gt Needle Technology (If Enabled)

    While maintaining the desired needle angle, insert the needle into the skin. Refer to the specific device’s Instruction for Use for more information Proceed with insertion – watch needle advancement onscreen. The solid green lines represent the needle shaft and tip. During advancement, maintain the needle trajectory in the center of the intended target structure.
  • Page 60 Modify the angle of the needle (up or down) to place the Point of Intersection Circle in the center of the intended target structure. A steeper insertion angle may be necessary for deep structures while a shallow angle may be appropriate for superficial anatomy Needle Shaft Needle Trajectory Point of...
  • Page 61 When attempting vessel access, watch for the following: • Anterior vessel wall indenting (once the puncture occurs the vessel will return to normal shape) • Blood return in the device • Needle reflection (flash of the needle tip) on the ultrasound image Note: When the virtual needle tip passes the ultrasound plane the color of the virtual needle shaft will change but still represents the virtual needle tip position.

  • Page 62: Troubleshooting

    16. TROUBLESHOOTING 16.1. Site~Rite® 8 Ultrasound System Troubleshooting ® Troubleshooting – Site~Rite 8 Ultrasound System SYMPTOM DESCRIPTION SOLUTIONS Error Code Reboot the system. EC:201-203 Ultrasound Hardware Failure Note: If error persists, call Customer Service at: 1-800-545-0890. An alternate EC:205-206 number may be available in the System Information Tab (Section 11.5). EC:211 If applicable, ensure the probe is securely connected to the system.
  • Page 63 ® Troubleshooting – Site~Rite 8 Ultrasound System SYMPTOM DESCRIPTION SOLUTIONS Verify that the printer is on. Error Code Verify that the printer has paper. EC:104 Check the printer’s power cable and connection to the system. Printer Error Refer to Printer Instructions for Use. Note: If error persists, call Customer Service at: 1-800-545-0890.
  • Page 64 ® Troubleshooting – Site~Rite 8 Ultrasound System SYMPTOM DESCRIPTION SOLUTIONS Error Code Restart the system. EC:111 System Error Note: If error persists, call Customer Service at 1-800-545-0890. An alternate EC:113 number may be available in the System Information Tab (Section 11.5). EC:199 Failed to read configuration file.

  • Page 65: Cue™ Needle Tracking System Troubleshooting (If Enabled)

    16.2. Cue™ Needle Tracking System Troubleshooting (if enabled) Toubleshooting - Cue™ Needle Tracking System (if enabled) SYMPTOM DESCRIPTON SOLUTIONS Ensure the Cue™ Needle Tacking System Probe is securely connected to the system. Error Code Cue™ Needle Tacking System Restart the system. EC:501 Sensor Disconnect Error Note: If error persists, call Customer Service at: 1-800-545-0890.
  • Page 66 If the Performance Indicator is low, perform the following steps: Hold the probe still. If the Performance Indicator decreases during needle approach, withdraw the needle and slowly re-approach. Remove metal, magnetic, and electronic objects in close proximity to the probe (bed rails, jewelry, mobile phone, pumps, bed/table frames, Cue™ Activator, etc.).

  • Page 67: Cue™ Needle Tracking System Troubleshooting

    16.2.1. Cue™ Needle Tracking System Troubleshooting To Test the functionality of the Cue™ Needle Tracking System, perform the following steps: Move all metal objects (including the needle) at least 4 inches away from the Cue™ Needle Tracking System Probe. Move all active electronic devices and magnetic articles at least 3 feet away. Obtain a small container of water.

  • Page 68: Pinpoint™ Gt Needle Technology Troubleshooting Steps

    Troubleshooting - Pinpoint™ GT Needle Technology (if enabled) SYMPTOM DESCRIPTION SOLUTIONS Likely cause: The system is in Select the freeze button to exit freeze mode. freeze mode. Move all metal objects including the needle at least 2 feet (61cm) away from the Pinpoint™ GT Needle Technology Probe.

  • Page 69: Clean And Disinfecting The Equipment

    Do not attempt to sterilize the Site~Rite® 8 Ultrasound System or probe; damage to the equipment may occur as a result. Caution: Use only Bard Access System cleaning and disinfection procedures. Failure to do so may damage the device. Caution: Use only approved or recommended cleaners or disinfectants to avoid damaging the equipment.

  • Page 70: Warranty

    18. WARRANTY Bard Access Systems Inc. warrants to the original purchaser that this product will be free from defects in material and workmanship for a period of one (1) year from the date of purchase. If this product proves to be so defective, purchaser may return same to Bard Access Systems Inc.

  • Page 71: Acoustic Information

    22. ACOUSTIC INFORMATION 22.1. Acoustic Output Summary Table (X denotes MI X (X denotes spta.X Description Operating statistically FDA I Published statistically FDA MI Published spta.3 of Probe Mode determined Values determined Values maximum) maximum) Peripheral Vessel Peripheral Vessel < 720 mW/cm <...

  • Page 72: Acoustic Output Reporting Table - Linear Probe 32Mm

    22.2. Acoustic Output Reporting Table – Linear Probe 32mm Transducer Model: Linear Probe 32mm Operating Mode: B-Mode Index Label Non-scan Scan Non-scan ≤1cm >1cm aprt aprt 0.543 0.0418 Maximum index value (MPa) 1.40 (mW) 3.22 min of [W. ), I (mW) TA,3 (cm)

  • Page 73: Acoustic Output Reporting Table - Linear 20Mm Cue™ Needle Tracking System Probe

    22.3. Acoustic Output Reporting Table – Linear 20mm Cue™ Needle Tracking System Probe Transducer Model: Linear 20mm Cue™ Needle Tracking System Probe Operating Mode: B-Mode Index Label Non-scan Scan Non-scan ≤1cm >1cm aprt aprt 0.517 0.134 Maximum index value (MPa) 1.40 (mW) 3.95...

  • Page 74: Acoustic Output Reporting Table - Linear 20Mm Pinpoint™ Gt Needle Technology Probe

    22.4. Acoustic Output Reporting Table – Linear 20mm Pinpoint™ GT Needle Technology Probe Transducer Model: Linear 20mm Pinpoint™ GT Needle Technology Probe Operating Mode: B-Mode Index Label Non-scan Scan Non-scan ≤1cm >1cm aprt aprt 0.690 0.113 Maximum index value (MPa) 1.82 (mW) 4.86...

  • Page 75: Emc Tables

    23. EMC TABLES Warning: The use of accessories other than those specified in the “Overview” section may result in increased ® emissions or decreased immunity of the Site~Rite 8 Ultrasound System. Site~Rite® 8 Ultrasound System EMC Tables Guidance and Manufacturer’s Declaration - Emissions ®...
  • Page 76 Guidance and Manufacturer’s Declaration – Emissions ® The Site~Rite 8 Ultrasound System is intended for use in the electromagnetic environment specified below. The customer or ® user of the Site~Rite 8 Ultrasound System should ensure that it is used in such an environment. Compliance Immunity Test EN/IEC 60601 Test Level...

  • Page 77: Technical Specifications

    24. TECHNICAL SPECIFICATIONS Operating and Storage Conditions Operating Temperature 50° F to 104° F (10°C to 40°C) Storage Temperature -0° F to 104° F (-18°C to 40°C) ≤ 90% Relative Humidity (non-condensing) Operating Humidity ≤ 95% Relative Humidity (non-condensing) Storage Humidity Pinpoint™...
  • Page 78 System Accuracy with Needle Guides Measurement Error Range‡ ≤ 1.5mm Vertical 5–35mm ≤ 1.5mm Horizontal 5–35mm ® ‡ Available depth range of the Site~Rite Needle Guide and Pinpoint™ GT Needle Guide Measurement Tool Error Measurement Error Range Area < 10% 0–804mm Diameter <...

  • Page 79: Site~Rite® 8 Ultrasound System Wireless Technologies (If Enabled)

    25. SITE~RITE® 8 ULTRASOUND SYSTEM WIRELESS TECHNOLOGIES (if enabled) ® The Site~Rite 8 Ultrasound System incorporates a standard IEEE 802.11 b/g/n transceiver to provide a wireless Ethernet connection to DICOM servers and network PC’s. This connection can be used for archiving data. Bluetooth™ capabilities are also included for wireless pairing to approved accessories.
  • Page 80 An issued or revision date for these instructions is included for the user’s information. In the event that two years have lapsed between the issued revision date and use of the product, contact Bard Access Systems, Inc. to see if any additional product information is available.

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