Instructions for Use
79 Pages
Preview
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Instructions for Use
SYMBOLS Consult instructions for use
Temperature Limitation
Humidity Limitation
Manufacturer
Keep Dry
Type BF Applied Part
Do not dispose 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
Date of Manufacture
®
IPX1
Drip Proof Equipment
Catalog Number
Class II electrical equipment
The Green Dot
Quantity
Serial Number
Atmospheric Pressure Limitation
Direct Current
Caution
Warning: Magnetic Field
Site~Rite 8 Ultrasound System
TABLE OF CONTENTS 1.
OVERVIEW ... 3 1.1. Site~Rite® 8 Ultrasound System Device Description ... 3 1.2. Needle Guidance (if enabled) ... 3 1.2.1. Cue™ Needle Tracking System Description ... 3 1.2.2. Pinpoint™ GT Needle Technology Description ... 3 1.3. Site~Rite® Ultrasound System Indications for Use ... 4 1.4. Clinical Applications for Cue™ Needle Tracking System ... 4 1.5. Clinical Applications for Pinpoint™ GT Needle Technology ... 4 1.6. Site~Rite® 8 Ultrasound System Components ... 4 1.7. Site~Rite® 8 Ultrasound System Compatible Accessories... 5 1.8. Cue™ Needle Tracking Compat ble Accessories... 5 1.9. Needles for Use with Cue™ Needle Tracking System ... 5 1.10. Pinpoint™ GT Needle Technology Compatible Accessories ... 5 1.11. Needles for Use with Pinpoint™ GT Needle Technology ... 5 2. WARNINGS AND CAUTIONS... 6 2.1. Site~Rite® 8 Ultrasound System Warnings ... 6 2.2. Cue™ Needle Tracking System Warnings (if enabled) ... 7 2.3. Pinpoint™ GT Needle Technology Warnings (if enabled) ... 7 2.4. Site~Rite® 8 Ultrasound System Cautions ... 7 2.5. Cue™ Needle Tracking System Cautions (if enabled) ... 9 2.6. Pinpoint™ GT Needle Technology Cautions (if enabled) ... 9 3. PHYSICAL FEATURES ... 10 3.1. Console Features ... 10 3.2. Compatible Probes ... 11 3.3. Connecting the Ultrasound Probe (if applicable) ... 11 3.4. LED Status Indicators ... 12 3.5. Mounting Accessories ... 12 4. CONNECTING THE BATTERY... 12 5. POWER OPTIONS ... 13 5.1. Power On ... 13 5.2. Power Menu ... 13 6. NAVIGATING THE DISPLAY ... 13 6.1. Touch Screen ... 13 6.2. USB Keyboard (optional) ... 13 6.3. Probe ... 14 7. MAIN ULTRASOUND SCREEN ... 15 7.1. Information Bar... 15 7.1.1. Time ... 16 7.1.2. Date ... 16 7.1.3. Patient Information ... 16 7.1.4. Catheter Trim Length ... 16 7.1.5. Exit Site Marking... 16 7.1.6. File Management - Accessing Saved Patient Images ... 16 7.1.7. Battery Information ... 16 7.2. Catheter Icons ... 17 7.3. Main Toolbar ... 17 7.3.1. Depth ... 17 7.3.2. Gain ... 17 7.3.3. Freeze ... 17 7.3.4. Pinpoint™ GT Needle Technology Mode (if enabled) ... 17 7.3.5. SHERLOCK 3CG™ TCS Mode (if enabled) ... 17 7.3.6. Settings ... 17 7.4. Depth Markers and Image Depth Scale ... 18 7.5. Probe Orientation ... 18 8. FREEZE MODE ... 19 8.1. Save/Print ... 19 8.2. Measurement Tool ... 19 9. CUE™ NEEDLE TRACKING SYSTEM MODE (if enabled) ... 22
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Site~Rite 8 Ultrasound System
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9.1. Enabling Cue™ Needle Tracking System ... 22 9.2. Activating the Cue™ Needle Tracking System Compat ble Needle ... 22 9.3. Cue™ Needle Tracking System Home Screen ... 23 9.3.1. Probe Face Overlay... 23 9.3.2. Performance Indicator ... 25 9.4. Cue™ Needle Tracking System Overlay ... 26 9.4.1. Out-of-Plane Insertion... 26 9.4.2. In-Plane Insertion ... 28 10. PINPOINT™ GT NEEDLE TECHNOLOGY MODE (if enabled) ... 29 10.1. Pinpoint™ GT Needle Technology Home Screen. ... 29 10.2. Pinpoint™ GT Needle Technology Calibration... 30 10.3. Pinpoint™ GT Needle Technology Needle Tracking ... 31 10.4. Pinpoint™ GT Needle Technology Freeze Mode ... 32 10.4.1. Save/Print ... 32 10.5. Pinpoint™ GT Needle Technology Errors ... 33 10.6. Pinpoint™ GT Needle Technology Virtual Needle Image – Out-of-Plane Needle Insertion. ... 34 10.7. Pinpoint™ GT Needle Technology Virtual Needle Image – In-Plane Needle Insertion ... 36 11. SYSTEM SETTINGS ... 39 11.1. Ultrasound Settings ... 39 11.2. Cue™ Needle Tracking System Settings (if enabled) ... 40 11.2.1. Calibration ... 41 11.3. General Settings ... 42 11.3.1. Add Feature Activation Key ... 42 11.3.2. System Password. ... 43 11.4. Connectivity Settings ... 44 11.4.1. WiFi Networks ... 45 11.4.2. Configure Network Settings ... 46 11.4.3. DICOM Settings (If enabled) ... 47 11.4.4. DICOM Conformance Statement ... 48 11.4.5. Bluetooth™ Wireless Technology (if enabled)... 48 11.5. System Information ... 48 12. PATIENT INFORMATION ... 49 13. CLINICIAN PRESETS... 50 14. ACCESSING SAVED PATIENT IMAGES ... 50 15. OPERATING THE SITE~RITE® 8 ULTRASOUND SYSTEM ... 52 15.1. Access using the Cue™ Needle Tracking System (if enabled) ... 53 15.2. Access Using Pinpoint™ GT Needle Technology (if enabled)... 55 16. TROUBLESHOOTING ... 59 16.1. Site~Rite® 8 Ultrasound System Troubleshooting ... 59 16.2. Cue™ Needle Tracking System Troubleshooting (if enabled) ... 61 16.2.1. Cue™ Needle Tracking System Troubleshooting ... 63 16.3. Pinpoint™ GT Needle Technology Troubleshooting (if enabled) ... 64 16.3.1. Pinpoint™ GT Needle Technology Troubleshooting Steps ... 65 17. CLEAN AND DISINFECTING THE EQUIPMENT ... 66 17.1. Cleaning and Intermediate Disinfection Procedure using PDI® Super Sani-Cloths® ... 66 17.2. Additional Cleaning and Compatible Chemical Information ... 66 18. WARRANTY ... 67 19. SERVICE AND REPAIR ... 67 20. UPGRADING ... 67 21. DISPOSAL INFORMATION ... 67 22. ACOUSTIC INFORMATION... 68 22.1. Acoustic Output Summary Table ... 68 22.2. Acoustic Output Reporting Table – Linear Probe 32mm ... 69 22.3. Acoustic Output Reporting Table – Linear 20mm Cue™ Needle Tracking System Probe ... 70 22.4. Acoustic Output Reporting Table – Linear 20mm Pinpoint™ GT Needle Technology Probe ... 71 23. EMC TABLES ... 72 24. TECHNICAL SPECIFICATIONS ... 74 25. SITE~RITE® 8 ULTRASOUND SYSTEM WIRELESS TECHNOLOGIES (if enabled) ... 76
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Site~Rite 8 Ultrasound System
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1. OVERVIEW 1.1.
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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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1.7.
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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:
1.8.
Cue™ Activator mounting arm Pinpoint™ GT Needle Guides Site~Rite® Needle Guides Site~Rite® Probe Covers MER Roll Stand Optional printers with mounting hardware Kickstand mounting accessory Probe holder accessory Site~Rite® Keyboard USB storage device (flash/pen drive) with no external power connection Silex® Wireless Bridge
Cue™ Needle Tracking Compatible Accessories Cue™ Needle Tracking is compat ble with all Site~Rite® 8 Ultrasound System compatible accessories listed in section 1.7 EXCEPT:
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.
Warning:
1.9.
Site~Rite® Needle Guides
Needles for Use with Cue™ Needle Tracking System Needles for use with Cue™ Needle Tracking System:
Cue™ Needle Tracking System compat ble needles, marked with Cue™ compatibility symbol
1.10. Pinpoint™ GT Needle Technology Compatible Accessories Pinpoint™ GT Needle Technology is compatible with all Site~Rite® 8 Ultrasound System compat ble accessories listed in section 1.7 EXCEPT:
Site~Rite® Needle Guides Pinpoint™ GT Needle Technology is not qualified for use with Site~Rite® Needle Guides. Using Site~Rite® Needle Guides with the Pinpoint™ GT Needle Technology may result in injury to the patient.
Warning:
1.11. Needles for Use with Pinpoint™ GT Needle Technology Needles for use with PinpointTM GT Needle Technology:
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Pinpoint™ GT Safety Introducer Needle
Site~Rite 8 Ultrasound System
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2. WARNINGS AND CAUTIONS 2.1.
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Site~Rite 8 Ultrasound System Warnings
Warning:
Do not operate the Site~Rite® 8 Ultrasound System or the AC adapter in the presence of flammable anesthetics or gases; explosion may result.
Warning:
Use only the Site~Rite® 8 Ultrasound System AC adapter to charge the system. Using any other device to charge the system may damage the battery, cause intermittent or unpredictable operation, damage the system, result in injury, and will void the warranty.
Warning:
The following actions will void the warranty of the Site~Rite® 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.
Connecting the Site~Rite® 8 Ultrasound System to any AC adapter other than the system adapter.
Connecting the Site~Rite® 8 Ultrasound System to any unauthorized accessory. Refer to the list of authorized accessories in the “Overview” section.
Installing unauthorized software.
Modification of system software without authorization by Bard Access Systems.
Warning:
Inspect the AC adapter and battery cord for damage. If any of the prongs are damaged, use battery power until a replacement cord is obtained.
Warning:
Verify that all accessories attached to the system comply with applicable safety standards. Use of non-compliant accessories may increase the risk to the patient or user.
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.
Warning:
Equipment that 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; doing so may cause the system to tip. Refer to the roll stand instructions for weight limits or additional warnings.
Warning:
Prior to use each time, inspect the system for damage. If any problems are found, discontinue use immediately and contact service personnel authorized by Bard Access Systems. Using a damaged system could cause injury to a patient or user.
Warning:
Unapproved power cords should not be used with this system; doing so may increase risk to the patient or user and/or damage the system.
Warning:
This product should only be operated by qualified medical personnel.
Warning:
Do not use the Site~Rite® 8 Ultrasound System for ophthalmic indications; ophthalmic use may cause patient injury.
Warning:
Misuse of the Site~Rite® 8 Ultrasound System may result in damage to the equipment or increase risk to the patient or user.
Warning:
When using Site~Rite® Needle Guides and Pinpoint™ GT Needle Guides, use the sterile legally marketed plastic probe cover included in the kit with the needle guides. To ensure proper performance, follow the Site~Rite ® Needle Guides instructions for use.
Warning:
Do not place and/or use the Site~Rite® 8 Ultrasound System and its components or accessories in the presence of strong magnetic fields such as Magnetic Resonance Imaging (MRI) devices. The high magnetic fields created by an MRI device will attract the equipment with a force sufficient to cause death or serious injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment. If a needle tracking technology is enabled, the magnetic and the RF fields associated with the MRI environment may interfere with the display of needle location. Consult the MRI manufacturer for more information.
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2.2.
Cue™ Needle Tracking System Warnings (if enabled)
Warning:
Use only Cue™ Needle Tracking System compatible needles with the Cue™ Needle Tracking System. Use of unapproved needles may result in patient injury.
Warning:
Misuse of the Cue™ Needle Tracking System may result in damage to the equipment or personal injury.
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.
Warning:
The Cue™ Activator contains strong magnets which may affect devices sensitive to magnetic fields.
2.3.
Pinpoint™ GT Needle Technology Warnings (if enabled)
Warning:
Use only Pinpoint™ GT Needles with the Pinpoint™ GT Needle Technology. Use of unapproved needles may result in patient injury or equipment damage.
Warning:
Pinpoint™ GT Needle Technology is not qualified for use with Site~Rite® Needle Guides. Using Site~Rite® Needle Guides with the Pinpoint™ GT Needle Technology may result in injury to the patient.
Warning:
Misuse of the Pinpoint™ GT Needle Technology may result in damage to the equipment or personal injury.
2.4.
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Site~Rite 8 Ultrasound System Cautions
Caution:
To avoid unnecessary strain on the user, use the medical device in a manner that is comfortable.
Caution:
During use, the AC connector needs to be easily access ble. In case of emergency, remove the power cord as soon as poss ble.
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.
Caution:
Do not attempt to sterilize the Site~Rite® 8 Ultrasound System or probe; damage to the equipment may occur as a result.
Caution:
When attaching the system to the roll stand or kickstand, do 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 may cause the display to disconnect from the mount.
Caution:
The Site~Rite® 8 Ultrasound System contains an internal battery. Dispose of dead battery packs in accordance with local regulations; improper disposal may present an environmental hazard.
Caution:
Do not allow liquid to enter the system, AC adapter, connectors, or ports; damage to the equipment may occur.
Caution:
Only qualified personnel should attempt to service this equipment. The Site~Rite® 8 Ultrasound System contains static sensitive components and circuits. Failure to observe proper static-control procedures may result in damage to the system.
Caution:
To avoid damage to the device operating system, shut down the device through the power control window. (See Section 5)
Caution:
The adverse biological effects of ultrasound on tissue appear to be threshold effects. When tissue is repeatedly exposed to ultrasound, with intervals in between, there will likely be no cumulative biological effect. If, however, a certain threshold has been passed, biological effects may occur. While the Site~Rite ® 8 Ultrasound System acousticoutput parameters fall well below all US Food and Drug Administration (FDA) thresholds for adverse biological effects, any given ultrasound procedure should be performed using the principle of ALARA (As Low As Reasonably Achievable). The licensed medical practitioner should limit the time of patient exposure to ultrasonic radiation using the principles of ALARA.
Caution:
Hot water (in excess of 113°F or 45°C) may damage the system or the probe.
Caution:
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
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Caution:
Cardiac-rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in the diagnostic range of Mechanical Index (MI) values. See the specific package insert for the specific contrast agent being used for details.
Caution:
Do not twist, bend, swing, or pull the probe cable in excess of that required during normal use of the probe. Excessive force on the cable may cause equipment failure, intermittent operation, or unpredictable operation.
Caution:
When using the Site~Rite® 8 Ultrasound System probe in a sterile environment, the probe and part of the probe cable must be covered with a sterile, acoustically transparent plastic probe cover.
Caution:
When disinfecting the probe with a liquid disinfectant, do not soak the probe cable, cable bend relief, or probe buttons; doing so may damage the probe.
Caution:
Apply to the acoustic window (or face) of the probe only commercially available ultrasonic couplant that has been specifically formulated for use in medical applications.
Caution:
Use water or rubbing alcohol and a soft cloth to remove ultrasonic couplant from the acoustic window (or face) of the probe; failure to do so may scratch the acoustic window.
Caution:
Do not allow the ultrasonic couplant to dry on the acoustic window (or face) of the probe. If the couplant should dry, use water or rubbing alcohol and a soft cloth to remove it. Never use a tool of any kind to remove dry ultrasonic couplant from the acoustic window (or face) of the probe.
Caution:
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.
Caution:
Always snap the needle guides 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 v bration; doing so may dislodge sensitive components and cause intermittent or unpredictable operation.
Caution:
If a probe is damaged in any way, discontinue using it immediately, as damage to the system may occur.
Caution:
Avoid subjecting the system or probe to excessive mechanical shock (e.g. throw and/or drop); damage to the system may occur as a result.
Caution:
Do not use the probe with high-frequency surgical equipment; doing so may damage the Site~Rite® 8 Ultrasound System.
Caution:
Do not connect to an unsecured network; doing so may compromise data security.
Caution:
This equipment is not designed to meet the standards for Home Healthcare Environments in accordance with IEC 60601-1-11:2010. This equipment should be operated in clinical environments only.
Caution:
Do not submerge the probe in liquid or allow fluid to enter the connectors. Damage to the equipment may occur.
Caution:
Prior to each use, inspect the integrity of all power cords and connectors as well as the integrity of the unit itself. If any problems are found, discontinue use immediately and contact an authorized service representative. Use of a damaged power cord could damage the machine.
Caution:
Do not force the probe connector; damage to the connector and system could result.
Caution
If operating the device in temperatures exceeding 90°F (32°C), the battery charging functionality may be disabled to protect the battery. To charge the battery in temperatures exceeding 90°F (32°C), the system may need to be turned off.
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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 cal brating. 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. Avoid operating the device near pumps, cauterizers, diathermy equipment, cellular phones, or other portable and mobile radio frequency communications equipment. Maintain equipment separation of at least 3 feet.
Caution:
Excessive movement of the probe may result in a temporary loss of needle tracking.
Caution:
The Activator produces a magnetic field. It should be kept away from any device that is sensitive to magnetic fields.
Caution:
Follow all care, handling and/or installation instructions included in this guide and on the packaging provided with the Activator and needles.
Caution:
Single-use items (e.g. needle trays, needle guides, needles and sheaths/ covers) must not be reused under any circumstances.
Caution:
Movement of the probe during calibration may result in calibration error.
Caution:
If needle tracking is not functioning properly, discontinue use of Cue™ Needle Tracking System.
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 objects, e.g., wired undergarments, metal instruments, watches, jewelry, electronics, metal bed rails, etc. at least 2 feet away from probe when calibrating. Failure to do so may impact needle tracking.
Caution:
Equipment operating in close proximity may emit strong electromagnetic or radio frequency 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 communications equipment. Maintain equipment separation of at least 5 ft (1.5 m).
Caution:
Excessive movement of the probe after calibration may result in reduced needle tracking accuracy.
Caution:
During insertion, use a light touch to prevent needle deflection and/or bending. Needle deflection and/or needle bending may reduce needle tracking accuracy.
Caution:
To ensure accuracy, do not apply force or pressure that may leverage the needle. This may result in needle deflection, bending or altering needle trajectory.
Caution:
Movement of the probe during calibration may result in calibration error.
Caution:
If needle tracking is not functioning properly, discontinue use of Pinpoint™ GT Needle Technology.
Caution:
To avoid reduced needle tracking accuracy, prior to insertion do not modify the straightness of the needle by bending.
Caution:
Improper technique and environmental conditions may introduce variation in accuracy.
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3.2.
Compatible Probes
Linear 32 mm Probe
3.3.
Linear 20mm Cue™ Needle Tracking System Probe
Linear 20mm Pinpoint™ GT Needle Technology Probe
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. Caution: Do not force the probe connector; damage to the connector and system could result. To remove the probe: 1. Press the two latches on the probe connector. 2. Gently pull on the connector to disconnect the probe.
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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
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Site~Rite 8 Ultrasound System
Probe Face Overlay View – Not Aligned
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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 button. To calibrate the probe: 1. 2.
Select the calibrate button on the Cue™ Needle Tracking System settings screen. Follow the on-screen instructions to hold the probe in the air, at least 3 feet from any metal, magnetic, or electronic devices (including watches, cell phones, etc.).
3.
While holding the probe still in the air, press the calibrate button. Maintain this position until the system indicates that calibration is complete.
4.
Upon completion of calibration, the Performance Indicator should improve. A Performance Indicator of 3 bars or higher is recommended before beginning any procedure.
Note: Maintain a distance of 4 inches between the Cue™ probe and Cue™ Activator to minimize the potential need for calibration.
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15.
OPERATING THE SITE~RITE® 8 ULTRASOUND SYSTEM The basic steps for operating the system in a procedure are listed below. 1.
Turn on the system (by pressing the power switch on the upper left side of the system).
2.
Verify the battery charge is sufficient for the procedure; otherwise connect the power adapter to the Site~Rite ® 8 Ultrasound System.
3.
Enter Patient Information as needed.
4.
Position the patient and perform ultrasound assessment.
5.
Apply conductive gel and probe covers per the Site~Rite® Probe Cover instructions for use. Refer to all notes, cautions, and warnings at the end of this section. To drape the probe for sterile use, do the following: a) b) c) d) e) f) g) h)
Place the probe in the probe holder. Apply a layer of ultrasonic coupling gel on the acoustic window of the probe head. Make sure that the probe cover is fully rolled up. Place the probe cover over the probe head, being careful not to wipe off the coupling gel. Cover the probe and cable with the probe cover. Smooth the probe cover over the acoustic window of the probe head to remove any air bubbles or folds in the cover. Use the latex-free poly-bands to hold the probe cover in place. Apply a layer of sterile coupling gel to the covered acoustic window.
6.
Attach needle guide to the probe, if needed, 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 disposed according to facility protocol. For cleaning the system, refer to “Cleaning and Disinfecting the Equipment,” Section 17.
Warning:
When using Site~Rite® Needle Guides and Pinpoint™ GT Needle Guides, use the sterile legally marketed plastic probe cover in the kit with the needle guides. To ensure proper performance, follow the Site~Rite ® Needle Guide and Pinpoint™ GT Needle Guide instructions for use.
Caution:
When using the Site~Rite® 8 Ultrasound System probe in a sterile environment, the probe and part of the probe cable must be covered with a sterile, acoustically transparent plastic probe cover.
Caution:
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.
Caution:
Always snap the needle guides on the probe hook. Do not slide the needle guide onto the needle guide hook, as the sterile cover may tear.
Note:
To purchase Site~Rite® Needle Guides, Pinpoint™ GT Needle Guides, and Probe Covers, contact Bard Access Systems customer service at 1-800-545-0890 or visit our website at www.bardaccess.com.
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c.
While maintaining the needle angle, insert the Cue™ Needle Tracking System compatible needle into the skin. Refer to the specific device’s Instructions for Use for more information.
d.
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.
e.
During advancement, maintain the Intersection Window centered with the intended target structure.
f.
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. It does not mean insertion has been successful or the structure of interest has been reached.
g.
When attempting vessel access, watch for: 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
h.
Complete procedure per suggested institutional guidelines.
5b. In-Plane Ultrasound Guided Insertion Using the Cue™ Needle Tracking System a.
Retrieve the activated needle and move it towards the side of the probe at a 45o angle until it is within 0.5 cm from the probe. Ensure the Cue™ Needle Tracking System virtual needle overlay appears on the display and follows needle movement. If needle tracking is not functioning properly, discontinue use of Cue™ Needle Tracking System.
Caution:
b.
Position the needle by adjusting the insertion angle and distance from the probe to align the Cue™ Needle Tracking System Overlay with intended target structure.
Note: In-Plane Mode does not have an Intersection Window.
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c.
While maintaining the desired needle angle, insert the needle into the skin. Refer to the specific device’s Instructions for Use for more information.
d.
Proceed with insertion – watch needle advancement onscreen. The solid green lines represent the needle shaft and tip.
e.
During advancement, maintain the needle trajectory in the center of the intended target structure. Maintain the needle so that the virtual needle is centered in the Probe Face Overlay and the virtual needle is green.
f.
When attempting vessel access, watch for: - Anterior vessel wall indenting (once the puncture occurs the vessel will return to normal shape) - Blood return in the needle hub - Needle reflection (flash of the needle) on the ultrasound image
g.
Complete procedure per suggested institutional guidelines.
15.2. Access Using Pinpoint™ GT Needle Technology (if enabled) 1.
Prepare the Site~Rite® 8 Ultrasound System. a.
Verify the battery charge is sufficient for the procedure; otherwise connect the power adapter to the Site~Rite® 8 Ultrasound System.
b.
Enter Patient Information as needed.
2.
Position the patient and perform ultrasound assessment.
3.
Prepare the sterile field.
4.
a.
Ensure all metallic objects are removed from the surrounding location (at least 2 feet away). If an object, such as a bed rail, cannot be moved, take precautions to make the object stationary during the procedure.
b.
Retrieve and open the Pinpoint™ GT Safety Introducer Needle. Place contents in a location consistent with current introducer practice.
c.
Drape the ultrasound probe for sterile use (Refer to Probe Cover Instructions for Use.)
d.
If applicable, anesthetize the insertion site (per institution protocol).
Pinpoint™ GT Needle Technology Cal bration a.
Using the Pinpoint™ GT Needle Technology Probe navigation controls, select the GT button. (Refer to section 10) Note: 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. (Refer to section 10.2)
d.
Place needle at least 2 feet away from probe.
e.
Hold the probe stationary and upright, press the ‘OK’ button on the probe to begin calibration. Cal bration is only required prior to inserting the needle into the patient.
Note: When the calibration cycle begins, the status banner will display “CALIBRATING … HOLD PROBE STILL”. Once the system is calibrated, the status banner will display “READY...LIMIT PROBE MOVEMENT”. Keep the needle 2 feet away from the probe until the calibration cycle is complete. Caution:
Movement of the probe during calibration may result in calibration error.
Caution:
Keep the needle and any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, electronics metal bed rails, etc. at least 2 feet away from probe when cal brating. 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. Avoid operating the device near pumps, cauterizers, diathermy equipment, cellular phones, or other portable and mobile radio frequency communications equipment. Maintain equipment separation of at least 5 ft (1.5 m).
Caution:
Excessive movement of the probe after calibration may result in reduced needle tracking accuracy.
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c.
While maintaining the desired needle angle, insert the Pinpoint™ GT Safety Introducer Needle into the skin. Refer to the Pinpoint™ GT Safety Introducer Needle IFU for more information. i.
To maintain accuracy, use a ‘light touch’ (which is defined as minimal stress, force, or pressure on the needle during insertion).
Note: Once the needle enters the skin, it may be helpful to release pressure on the needle hub to assess Pinpoint™ GT Needle Technology System alignment with the structure of interest. Caution:
During insertion, use a light touch to prevent needle deflection and/or bending. Needle deflection and/or needle bending may reduce needle tracking accuracy.
Caution:
To ensure accuracy, do not apply force or pressure that may leverage the needle. This may result in needle deflection, bending or altering needle trajectory
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d.
Without leveraging the needle, proceed with insertion – watch needle advancement onscreen. The solid yellow line represents the needle shaft and tip.
e.
During advancement, maintain the needle trajectory in the center of the intended target structure. Maintain the needle so that the trajectory is centered in the In-Plane Box and the In-Plane Box is green.
f.
When attempting vessel access, watch for: Anterior vessel wall indenting (once the puncture occurs the vessel will return to normal shape) Blood return in the needle hub Needle reflection (flash of the needle) on the ultrasound image
g.
Complete procedure per suggested institutional guidelines.
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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. for repair, replacement, refund, or credit at Bard Access Systems Inc.’s option. All returns must be authorized in advance in accordance with Bard Access Systems Inc.’s Returned Goods Policy found in its then current Price List. The warranty on the repaired or replaced unit continues from the purchase date of the original unit. The liability of Bard Access Systems Inc. under this limited warranty does not extend to any abuse, misuse, modification, improper storage, alteration, further manufacture, packaging or processing of this product or repair by anyone other than a Bard Access Systems Inc. representative. The following will also void this limited warranty:
Opening or servicing any component of the Site~Rite® 8 Ultrasound System by anyone other than Bard Access Systems authorized service personnel. Removing system labels by anyone other than service personnel authorized by Bard Access Systems. Connecting the Site~Rite® 8 Ultrasound System display to any AC adapter other than the system adapter. Connecting the Site~Rite® 8 Ultrasound System to any unauthorized accessory. Refer to the list of authorized accessories in the “Overview” section. Installing unauthorized software. Modification of system software without authorization by Bard Access Systems.
THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, (INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). THE LIABILITY AND REMEDY STATED IN THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF BARD ACCESS SYSTEMS INC. AND REMEDY 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 CONSEQUENTIAL DAMAGES ARISING OUT OF ITS HANDLING OR USE. Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to additional remedies under the laws of your state/country.
19.
SERVICE AND REPAIR The Site~Rite® 8 Ultrasound System does not require any scheduled maintenance, system checks, or calibration. For servicing information or to return your Site~Rite® 8 Ultrasound System for repair, please contact Bard Access Systems technical/clinical support at 1-800-443-3385.
20.
UPGRADING Contact your local Bard Access Systems representative for a USB drive with the latest version of Bard Access Systems applications. For U.S. customers only, available upgrades may also be obtained by visiting www.bardaccess.com/products/ultrasound. To upgrade a Site~Rite® 8 Ultrasound System, do the following:
21.
1.
Insert USB drive into one of the USB ports on the Site~Rite® 8 Ultrasound System.
2.
Answer yes when prompted to proceed with the upgrade.
3.
Do not attempt to cancel the upgrade procedure or remove the USB drive, as this may cause applications to malfunction. Follow the onscreen prompts to complete the software upgrade. If an error occurs during upgrading procedure, reboot the system and repeat the upgrade procedure again. If the error persists, contact the Bard Access Systems technical/clinical support at 1-800-443-3385.
4.
Restart the system.
5.
Confirm desired software version is displayed in the system information (section 11.5). Now it is safe to remove the USB drive.
DISPOSAL INFORMATION To return the Site~Rite® 8 Ultrasound System for end-of-life recycling, please contact your nearest Bard sales or distribution office in the country of purchase. Caution:
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The Site~Rite® 8 Ultrasound System contains an internal battery. Dispose of dead battery packs in accordance with local regulations; improper disposal may present an environmental hazard.
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Quality of Service (QoS) – Bluetooth The Bluetooth™ functionality for the Site~Rite® 8 Ultrasound System operates on a best efforts basis, since latency in data transmission will not affect critical ultrasound imaging. As these connections are point to point, they do not require or rely on a formal QoS WLAN. The link capacity between devices is designed to provide the necessary bandwidth for proper data transmission, without competition for resources between devices. To ensure a proper connection, keep the separation distance between Bluetooth™ devices and the Site~Rite® 8 Ultrasound System console as short as possible. The maximum operating distance for Bluetooth™ technology is < 10 meters. Bluetooth™ devices generally perform better at shorter distances however, on the order of ~3 meters, with a direct line of sight preferable. IEEE 802.11b/g/n Wireless Security To guard against unauthorized access to network resources, ensure that the Site~Rite ® 8 Ultrasound System is connected to a secure network. Use of WPA2 security is preferred over older protocols, such as WEP, as it provides a more secure network. Contact your local IT administrator for more information on which networks can be used and what settings should be used. Bluetooth™ Security The Site~Rite® 8 Ultrasound System employs Bluetooth™ connectivity for use with approved accessories. 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 approved accessories to be used with the system. Wireless coexistence issues and mitigations: There is a potential for wireless conflicts, as 802.11b/g/n and Bluetooth™ both operate on the 2.4 GHz frequency band, as well as interference from other RF devices. If you encounter problems connecting to a network or Bluetooth™ device, remove or separate poss ble interfering sources as much as possible. Objects and people obstructing line of sight connections between wireless devices can also cause interference. Maintain a clear path between the Site~Rite ® 8 Ultrasound System and paired accessories as much as possible to ensure highest performance.
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. Revision date: October 2018 Manufacturer: Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 U.S.A. Customer Service: 1-800-545-0890 Technical/Clinical Support: 1-800-443-3385 Fax: 1-801-522-4948 www.bardaccess.com Bard, Cue, Pinpoint, Sherlock, Sherlock 3CG, and Site~Rite are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © 2018 C. R. Bard, Inc. All rights reserved. 0746465 1810R
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