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Bard Site-Rite 8 Скачать руководство пользователя страница 6

Site~Rite

®

8 Ultrasound System

Page 4

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)

The Site~Rite

®

8 Ultrasound System has two optional needle guidance technologies available depending on the selected

probe.

Both available needle guidance technologies are designed to track and display the location and trajectory of a needle
under ultrasound guidance. The technologies consist of software installed on an ultrasound system and sensors
incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The
software interprets the data from the sensors and creates a 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™ Needle Tracking System requires the use of a Cue™ 20mm Linear Probe, the Cue™ Needle Tracking
System Activator and a Cue™ compatible needle. The Cue™ 20mm Linear Probe contains sensors for tracking
Cue™ compatible needles (following magnetization by the Cue™ Needle Tracking System Activator). The tracked
needle’s current position, trajectory, and Intersection Window are displayed over the ultrasound image.

1.2.2. Pinpoint™ GT Needle Technology Description

Pinpoint™ GT Needle Technology requires the use of a 20mm Pinpoint™ GT Linear Probe and a Pinpoint™ GT
Safety Introducer Needle. The 20mm Pinpoint™ GT Linear Probe contains sensors for tracking Pinpoint™ GT
Safety Introducer Needles, which contain a permanent magnet within the safety canister of the needle. The
tracked needle’s current position, trajectory, and point of intersection with the ultrasound plane are displayed over
the ultrasound image.

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Содержание Site-Rite 8

Страница 1: ...Instructions for Use...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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