Bard Site-Rite 8 Instructions For Use Manual Download Page 1

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Instructions for Use

Summary of Contents for Site-Rite 8

Page 2: ...ose with ordinary municipal waste Caution Federal U S A law restricts this device to sale by or on the order of a physician Federal Communications Commission IPX1 Drip Proof Equipment Date of Manufact...

Page 3: ...with Pinpoint GT Needle Technology 6 2 WARNINGS AND CAUTIONS 7 2 1 Site Rite 8 Ultrasound System Warnings 7 2 2 Cue Needle Tracking System Warnings if enabled 8 2 3 Pinpoint GT Needle Technology Warni...

Page 4: ...4 1 Out of Plane Insertion 27 9 4 2 In Plane Insertion 29 10 PINPOINT GT NEEDLE TECHNOLOGY MODE if enabled 30 10 1 Pinpoint GT Needle Technology Home Screen 30 10 2 Pinpoint GT Needle Technology Calib...

Page 5: ...oting 65 16 3 Pinpoint GT Needle Technology Troubleshooting if enabled 65 16 3 1 Pinpoint GT Needle Technology Troubleshooting Steps 66 17 CLEAN AND DISINFECTING THE EQUIPMENT 67 17 1 Cleaning and Int...

Page 6: ...virtual image of the needle on the ultrasound display providing clinicians with a visual representation of the needle during the insertion process 1 2 1 Cue Needle Tracking System Description Cue Need...

Page 7: ...line arterial line placement access to fistula and grafts and general vein and artery access Interventional Guidance for biopsy and drainage Superficial Assessment of breast thyroid parathyroid testic...

Page 8: ...Rite Needle Guides Warning Cue Needle Tracking is not qualified for use with Site Rite Needle Guides Using Site Rite Needle Guides with Cue Needle Tracking may result in injury to the patient 1 9 Need...

Page 9: ...relies on basic insulation only should not be used with this system Failure to comply could result in increased risk to the patient or user Warning Do not pull on cables or overload the roll stand doi...

Page 10: ...provided in the packaging Ensure the unit is secure against the roll stand or kickstand mount Failure to do so may cause the display to disconnect from the mount Caution The Site Rite 8 Ultrasound Sy...

Page 11: ...on the probe hook Do not slide the needle guide onto the needle guide hook as the sterile cover may tear Caution Do not subject the probe to excessive vibration doing so may dislodge sensitive compone...

Page 12: ...tem Caution Improper technique and environmental conditions may introduce variation in accuracy 2 6 Pinpoint GT Needle Technology Cautions if enabled Caution Keep the needle and any ferromagnetic obje...

Page 13: ...not over tighten the screws doing so may damage the system Caution Use only the screws provided in the packaging Ensure the unit is secure against the roll stand or kickstand mount Failure to do so ma...

Page 14: ...be if applicable To connect the probe 1 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 Cautio...

Page 15: ...tem Move the switch to the position To extend the storage life of the battery return the switch to the X position prior to prolonged storage Failure to do so will degrade battery life Power Green indi...

Page 16: ...gate through the different features shown on the screen you can use the touch screen USB keyboard or probe Each one of these methods is described in more detail below When using the USB keyboard or pr...

Page 17: ...ress to select the current control Cursor Down Press to move cursor down Cursor Right Press to move cursor right Cursor Up Press to move cursor up Cursor Down Press to move cursor down Cursor Left Pre...

Page 18: ...s provided below 7 1 Information Bar The information bar is located at the top of the ultrasound screen This bar contains the following information Image Depth Scale Main Toolbar Information Bar Cathe...

Page 19: ...th a numeric keypad If a numeric value is entered the number shall appear on the Catheter Exit Site button 7 1 6 File Management Accessing Saved Patient Images By selecting this button previously save...

Page 20: ...ogy Mode if enabled If Pinpoint GT Needle Technology Mode is enabled the Pinpoint GT Needle Technology button shall appear as shown If Pinpoint GT Needle Technology Mode is not enabled on the system t...

Page 21: ...to the button pad on the ultrasound probe When using the Site Rite 8 Ultrasound System probe for vascular access hold it so that the side with the Needle Guide hook and button pad points away from the...

Page 22: ...of the selected catheter in a vessel It also allows for measurements of vessel area and diameter The following steps describe how to take measurements with the Site Rite 8 Ultrasound System Measureme...

Page 23: ...he user specified rule Vessel Measurement Indicator This icon indicates whether the vessel occupancy is calculated by Diameter or Area This can be set in the Ultrasound Settings Tab see Section 11 1 D...

Page 24: ...and diameter of the vessel Occupancy Circle will be displayed as shown below Note See Section 24 for system measurement error information Align with top of vessel Resizing Marker Resize circle to appr...

Page 25: ...f the USB cable to a USB port on the ultrasound system Ensure the Activator icon indicates a connection 9 2 Activating the Cue Needle Tracking System Compatible Needle Place a tray containing a Cue Ne...

Page 26: ...may be turned off in the Cue Needle Tracking System settings screen see Section 11 2 Current selected needle information Catheter size of current selected needle Probe face overlay Performance Indicat...

Page 27: ...on 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...

Page 28: ...tor to stop blinking Blinking bars The system is restarting the Cue Needle Tracking System in order to load in a new needle or to recover from an error Please wait until the loading is complete Loadin...

Page 29: ...ay advances through the Intersection Window the needle flash will appear within the Intersection Window Note Adjusting the angle of the needle up or down or changing the distance between the needle an...

Page 30: ...Site Rite 8 Ultrasound System Page 28 Actual View On Screen View Needle Shaft Needle Tip Ultrasound Beam Needle Trajectory Intersection Window...

Page 31: ...n Plane Insertion Actual View On Screen View Needle Tip Ultrasound Beam Needle Trajectory Needle Shaft Needle Tip Ultrasound Beam Needle Trajectory Needle Shaft Needle Shaft Needle Tip Needle Trajecto...

Page 32: ...cates the current calibration status of Pinpoint GT Needle Technology Freeze Button Freeze the Pinpoint GT Needle Technology virtual needle image by pressing the freeze button Calibrate Button This bu...

Page 33: ...flash upon entering Pinpoint GT Needle Technology Mode and whenever calibration is required Calibration Status Border This border indicates the calibration status of Pinpoint GT Needle Technology Yel...

Page 34: ...ency interference which could affect the performance of this device Avoid operating the device near pumps cauterizers diathermy equipment cellular phones or other portable and mobile radio frequency c...

Page 35: ...int GT Needle Technology Virtual Needle Image is saved to the system hard drive and any attached USB storage devices The image is also printed if a compatible printer is connected Pinpoint GT Needle T...

Page 36: ...ror 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...

Page 37: ...e Ultrasound Beam Needle Hub Needle Shaft Needle Trajectory Point of Intersection Circle Needle Tip Note Adjusting the angle of the needle up or down will change the position of the ultrasound beam po...

Page 38: ...Circle Needle Tip Note When the virtual needle image changes from yellow to violet it does NOT necessarily mean that you have advanced your needle beyond the target structure it means the needle is b...

Page 39: ...Virtual Needle Image In Plane Needle Insertion Actual View On Screen View Needle Tip Ultrasound Beam Needle Trajectory Needle Shaft Needle Tip Ultrasound Beam Needle Trajectory Needle Shaft Needle Tra...

Page 40: ...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 Note When the needle is position...

Page 41: ...Plane Box and Needle Trajectory are Green Probe View Ultrasound Image In Plane Box View Needle Shaft Needle Trajectory Misaligned In Plane Box and Needle Trajectory are Violet Probe View Ultrasound I...

Page 42: ...Mode Settings if enabled Power Menu Opens the Power Menu See Section 5 2 Name of Clinician if entered See Clinician Presets Section 13 Returns to the previous screen Toggles the catheter icons On Off...

Page 43: ...king overlay representing the needle On Off Displays information on how to improve the Performance Indicator Performance Indicator see Section 9 3 2 Provides information regarding the Cue Needle Launc...

Page 44: ...ng steps will calibrate the probe 1 Select the calibrate button on the Cue Needle Tracking System settings screen 2 Follow the on screen instructions to hold the probe in the air at least 3 feet from...

Page 45: ...o the feature 2 Press the unlock button 3 A correct key will result in a green check mark and activate the feature An incorrect key will result in a red X If activation failed re enter the activation...

Page 46: ...ssword protection is enabled the system will only prompt for the password upon system reboot or when the lock button is selected from the power menu see Section 5 2 The lock screen will appear as show...

Page 47: ...sword configuration screen Select to delete active directory configuration Select to edit active directory configuration Select to edit active directory configuration Select to add active directory co...

Page 48: ...tab at the top of the settings screen The following screen will appear Select drop down to select and restore from a previous backup file Backup patient data files Backup clinician settings data Media...

Page 49: ...Ultrasound System to WiFi perform the following steps 1 Select the Settings button Step 1 2 In the Settings window select the WiFi Connectivity Settings Step 2 3 Enable WiFi if not already enabled Ste...

Page 50: ...is filled in select Step 6 7 The system should now be connected to the WiFi network 11 4 2 Configure Network Settings Press the Settings button to configure network settings for either WiFi or Ethern...

Page 51: ...s 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 Exports a client certificate to USB for S...

Page 52: ...nabled To pair a Bluetooth Wireless Technology device and adjust Bluetooth Wireless Technology settings press the Bluetooth Wireless Technology settings button 11 5 System Information To access the sy...

Page 53: ...lete patient data Allows the user to edit existing patient information These changes will be applied to previously saved images for the current patient Returns to the previous screen Add new patient P...

Page 54: ...he Clinician button next to the Clinician dropdown menu 2 In the window that appears type the clinician name 3 Adjust the system settings as desired To delete a clinician preset select the Clinician i...

Page 55: ...the delete button Toggle between jpg files and log files To preview an image touch the center of the image see Step 4 To select or deselect an image touch the gray border of the image Select all dese...

Page 56: ...d as described in the Site Rite Needle Guide and Pinpoint GT Needle Guide Instructions for Use 7 Adjust the image as necessary 8 Perform the procedure 9 After use the probe cover should be removed and...

Page 57: ...e g wired undergarments metal instruments watches jewelry Activator electronics metal bed rails etc at least 3 feet away from the probe when calibrating Failure to do so may impact the accuracy of ne...

Page 58: ...nting once the puncture occurs the vessel will return to normal shape Blood return in the device Needle reflection 9flash of the needle tip on the ultrasound image h Complete Procedure per suggested i...

Page 59: ...When the GT button is selected the CALIBRATION REQUIRED message is displayed b Re scan the anatomy of interest using the Site Rite 8 Ultrasound System c Verify that the calibrate button is highlighted...

Page 60: ...or altering needle trajectory e Without leveraging the needle proceed with insertion watch needle advancement onscreen The yellow line represents the needle shaft and tip The violet circle represents...

Page 61: ...s centered in the In Plane Box the box will turn green c While maintaining the desired needle angle insert the Pinpoint GT Safety Introducer Needle into the skin Refer to Pinpoint GT Safety Introducer...

Page 62: ...ot turn on or turns on but immediately turns off 1 Press and hold the power switch for at least 2 seconds to turn the system on 2 Connect the system to AC power for operation and to recharge the batte...

Page 63: ...eatures 1 The feature activation key is system specific Ensure that the key you are using has the serial number of your system Note If error persists call Customer Service at 1 800 545 0890 An alterna...

Page 64: ...cut off when HDMI cable is plugged in 1 Plug the USB keyboard 2 With the system in the main ultrasound scree press ctrl shift right arrow The screen should rotate 3 Press ctrl shift q to restart the a...

Page 65: ...g System Probe does not detect Cue Needle Tracking System Compatible Needle Likely Cause The system is in freeze mode Select the freeze button to exit freeze mode Likely Cause The needle was introduce...

Page 66: ...nary and upright position 2 Stabilize the hand holding the needle Only modify the position of the needle to change the location of the Intersection Window Likely cause Needle detection reset is requir...

Page 67: ...erference caused by magnetic field due to 1 Probe movement during calibration 2 Probe movement post calibration 3 The Pinpoint GT Safety Introducer Needle is not at least 2 feet 61cm away from the pro...

Page 68: ...hor the probe in a stationary and upright position 2 Only modify the position of the needle to change the location of the point of insertion circle Likely cause Leveraging Bending of the needle 1 Use...

Page 69: ...nal Cleaning and Compatible Chemical Information For a list of additional disinfectants that are chemically compatible with the Site Rite 8 Ultrasound System and probe contact Bard Access Systems for...

Page 70: ...AVAILABLE TO PURCHASER FOR THIS PRODUCT WHETHER IN CONTRACT TORT INCLUDING NEGLIGENCE OR OTHERWISE AND BARD ACCESS SYSTEMS INC WILL NOT BE LIABLE TO PURCHASERS FOR ANY INDIRECT SPECIAL INCIDENTAL OR...

Page 71: ...ing Other 94 mW cm2 0 649 Peripheral Vessel 1 9 Cardiac 1 9 Fetal Imaging Other 1 9 20mm Linear Cue Needle Tracking System Probe B 11 1 mW cm2 Peripheral Vessel 720 mW cm2 Cardiac 430 mW cm2 Fetal Ima...

Page 72: ...cm 0 0683 FLy cm 0 134 Ipa 3 at max MI W m2 110 Operating Control Conditions 116 Hz scan rate 3 2cm scan length 64 lines per scan Focal depth 14mm Frequency 7 5 MHz Note 1 Information need not be prov...

Page 73: ...sec 0 134 PRF Hz 7420 pr at PIImax MPa 2 00 deq at PIImax cm Focal Length FLx cm 0 107 FLy cm 0 138 Ipa 3 at max MI W cm2 153 Operating Control Conditions 116 Hz scan rate 1 92cm scan length 64 lines...

Page 74: ...84 PRF Hz 7420 pr at PIImax MPa 2 45 deq at PIImax cm Focal Length FLx cm 0 0853 FLy cm 0 113 Ipa 3 at max MI W cm2 179 Operating Control Conditions 116 Hz scan rate 1 92cm scan length 64 lines per sc...

Page 75: ...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 Immunity Test EN IEC 60601 Te...

Page 76: ...gths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels Interference may occur in the vicinity of equipment containing a transmitter Reco...

Page 77: ...in x 2 5in 30cm x 22cm x 6cm Weight 5 4 lb 2 4kg Power Sources A C adapter Internal Battery Pack Power Consumption 60 Watts IEC 60601 1 Class II Type BF Applied Part Continuous Operation Internally Po...

Page 78: ...ter Ratio 10 0 100 Cue Needle Tracking System Accuracy Accuracy is within the Intersection Window Results have 95 confidence with 99 4 reliability from bench top testing in a controlled environment Ca...

Page 79: ...Ultrasound System uses WLAN to transmit patient data to a DICOM system and does not relate to real time scanning operations these communications are on a best efforts basis where other data on the net...

Page 80: ...ies Bluetooth technology does not provide rigorous security measures to prevent unauthorized access as wifi does As such appropriate measures should be taken to ensure that access is limited to approv...

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