Instructions for Use
96 Pages
Preview
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Instructions for Use (IFU)
SYMBOLS Storage Humidity Limitation
Consult instructions for use
Operating Humidity Limitation
Operating Temperature Limitation
Keep Dry
Direct Current
Manufacturer
Storage Temperature Limitation
Do not dispose with ordinary
Alternating Current
municipal waste Federal Communications
BF Type Applied Part
Commission
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician
Atmospheric Pressure Limitation
IPX1 Site~Rite Vision* II Ultrasound System
Drip Proof Equipment
Site~Rite Vision* II Ultrasound System
Site~Rite Vision* II Ultrasound System
TABLE OF CONTENTS OVERVIEW ... 1 Indications for Use ... 1 WARNINGS ... 3 CAUTIONS... 5 DISPLAY SCREEN & ICONS ... 8 Display Screen ... 8 Information Bar... 9 Battery Life ... 9 Power Indicators ... 10 Power--Control Window ... 10 Information--Bar Icons ... 10 Imaging Toolbar ... 11 Feature Toolbar... 12 Linear--Probe Icons ... 13 Convex--Probe Icons ... 14 NAVIGATING THE DISPLAY ... 16 Touch Screen... 16 Keyboard (Manual and Virtual) ... 16 Probe ... 16 Display Knob ... 16 OPERATING THE SITE~RITE VISION* II ULTRASOUND SYSTEM ... 17 Draping the Probe for Sterile Use ... 18 Recording Patient Information ... 20 ACCESSING SAVED PATIENT STUDIES AND IMAGES ... 21 Patient List ... 21 Study List ... 22 Image List ... 24 External Storage ... 25 SAVING IMAGES ... 27 Method 1: Quick Print/Save ... 27
Site~Rite Vision* II Ultrasound System
Method 2: Save File As ... 27 ADJUSTING SYSTEM SETTINGS ... 28 General ... 28 Network ... 29 Information ... 29 CUSTOMIZING PROCEDURES AND SETTINGS ... 30 Creating a Procedure ... 30 Renaming a Procedure... 31 Deleting a Procedure ... 31 Creating a Preset ... 32 IMAGING SYSTEM FEATURES... 33 Advanced Image Controls ... 33 Color--Flow Doppler ... 35 Doppler Window Adjustment ... 35 Doppler Window Sizing... 36 Doppler Window Positioning ... 36 Advanced Doppler Controls ... 37 Full--Screen Mode ... 38 Annotations... 38 Cine (Ultrasound Video Clips) ... 40 Measurements ... 41 Linear Measurements ... 44 Path Length ... 45 Circular/Elliptical Measurements ... 46 Custom--Area Measurement ... 47 Ratio of Two Lines ... 48 Ratio of Two Ellipses ... 49 Percentage of Vessel Occupied (Diameter)... 50 Percentage of Vessel Occupied (Area) ... 51 Deleting Measurements ... 52 Measurement Error ... 52 Depth Markers and Catheter--Size Icons... 53 Site~Rite Vision* II Ultrasound System
Site~Rite Vision* II Ultrasound System
Gamma, Brightness, and Contrast... 53 TROUBLESHOOTING... 54 Error Screen ... 54 Other Errors ... 55 CLEANING AND DISINFECTING THE EQUIPMENT ... 56 Cleaning Procedures ... 56 Disinfecting Procedures ... 56 WARRANTY... 58 SERVICE AND REPAIR ... 59 UPGRADING ... 59 DISPOSAL INFORMATION ... 59 ACOUSTIC INFORMATION ... 60 Prudent Use ... 60 Explanation of Mechanical and Thermal Indices ... 60 Parameters that Effect MI/TI ... 61 Acoustic Tables ... 62 Accuracy Statement ... 67 EMC TABLES ... 68 TECHNICAL SPECIFICATIONS ... 73 DICOM ... 74 DICOM Features ... 74 Modality Worklist (MWL) ... 74 Modality--Performed Procedure Steps (MPPS)... 74 Picture Archiving and Communication System (PACS) and Storage Commitment (SC) ... 74 Start Exam without the Worklist Feature... 75 Start Exam with the Worklist Feature ... 75 Using the Patient List Feature ... 80 Using the Study List Feature ... 80 Using the Image List Feature ... 80 Using the External Storage Feature ... 80 Saving Images in the PACS ... 80 Auto ... 80
Site~Rite Vision* II Ultrasound System
Manual ... 80 Saving Files ... 81 Print/Save... 81 Save ... 81 End Exam ... 82 Configuring Servers ... 82 Configuring Client Network ... 84 DICOM Conformance Statement ... 85
Site~Rite Vision* II Ultrasound System
OVERVIEW The Site~Rite Vision* II Ultrasound System is a mobile device that features real--time 2D ultrasound imaging, color--flow Doppler, procedural recordings (cine), patient--information storage, image annotations, and various measurement and calculation tools. The typical environment for ultrasound imaging may include hospitals, outpatient clinics, and long--term care facilities.
Indications for Use The Site~Rite Vision* II Ultrasound System is intended for diagnostic ultrasound imaging or fluid--flow analysis of the human body. Specific clinical applications include: •
Fetal
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Abdominal
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Intra--operative (semi--critical†)
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Pediatric
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Peripheral Vessel
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Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary)
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Musculo--skeletal (conventional and superficial)
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Cardiac (adult and pediatric)
Typical examinations performed using the Site~Rite Vision* II Ultrasound System include:
Imaging Applications
Exam Type (Adult & Pediatric)
Vascular
Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms and legs, select small vessels supporting organs
Vascular Access
Guidance for a PICC, CVC, dialysis catheter, port, PIV, and arterial--line placement, and peripheral vein and artery access
Abdominal
Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, appendix, and surrounding anatomical structures
Interventional and Intraoperative
Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative procedures (semi--critical†)
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Imaging Applications
Exam Type (Adult & Pediatric)
Superficial
Assessment of breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures
† Semi--critical is defined as clinical applications in which the probe contacts mucous membranes or non--intact skin. The Site~Rite Vision* II Ultrasound System is compatible with the following accessories:
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Site~Rite Vision* II Ultrasound System keyboard Site~Rite Vision* II Ultrasound System line cord
• • • • • • • •
Site~Rite Vision* II Ultrasound System 64 element, 20mm linear probe with buttons Site~Rite Vision* II Ultrasound System 128 element, 40mm linear probe with buttons Site~Rite Vision* II Ultrasound System 128 element convex probe Large basket Small basket Locking bin Brother* Printer with mounting hardware USB storage device (flash/pen drive) with no external power connection
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Site~Rite* Needle Guides Site~Rite* Probe Covers Sherlock* II Tip--Location System sensor Sherlock 3CG* Tip--Positioning System sensor Sherlock 3CG* Tip--Confirmation System sensor
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WARNINGS Warning: Do not operate the Site~Rite Vision* II Ultrasound System or the AC adapter and battery charger in the presence of flammable anesthetics or gases; explosion may result. Warning: Use only the Site~Rite Vision* II Ultrasound System AC adapter to charge the system. Using any other device to charge the system may damage the battery packs, cause intermittent or unpredictable operation, may damage the system, result in injury, and will void the warranty. Warning: The following actions will void the warranty of the Site~Rite Vision* II 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.
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Removing system labels by anyone other than service personnel authorized by Bard Access Systems.
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Connecting the Site~Rite Vision* II Ultrasound System display to any AC adapter other than the system adapter.
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Connecting the Site~Rite Vision* II Ultrasound System to any unauthorized accessory. Refer to the list of authorized accessories in the “Overview” section.
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Installing unauthorized software.
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Modification of system software settings 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. 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 Vision* II 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.
Warning: Do not pull on cables or overload the roll stand (the basket weight limit is 5 lbs/2.67 kg); doing so may cause the system to tip. 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 of the equipment.
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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 system, with its applicable accessories, is intended for use by healthcare professionals only. If used in a domestic environment, this system could cause radio interference or disrupt the operation of nearby equipment. It may be necessary to take mitigation measures such as reorienting or relocating the Site~Rite Vision* II Ultrasound System or shielding the location.
Warning: This product should only be operated by qualified medical personnel.
Warning: Do not use the Site~Rite Vision* II Ultrasound System for ophthalmic indications; ophthalmic use may cause patient injury. Warning: Misuse of the Site~Rite Vision* II Ultrasound System may result in damage to the equipment or injury to people. Warning: Use only Bard Access Systems probes with this system. Use of unapproved probes may result in injury to a patient and/or damage to the equipment. Warning: When using Site~Rite* Needle Guides on the Site~Rite Vision* II Ultrasound System probe, use only sterile legally marketed plastic probe covers (sheaths) that are up to 1.0 mil/0.001 inches/0.0254 mm thick. Warning: The following actions void the warranty of the Site~Rite Vision* II Ultrasound System and may result in injury or equipment damage:
•
Opening or servicing the display or the probe housing by anyone other than service personnel authorized by Bard Access Systems.
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Removing system labels by anyone other than service personnel authorized by Bard Access Systems.
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Opening or servicing the AC adapter by anyone other than service personnel authorized by Bard Access Systems.
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Connecting the Site~Rite Vision* II Ultrasound System display to any power source other than the Site~Rite Vision* II Ultrasound System AC adapter.
•
Connecting the Site~Rite Vision* II Ultrasound System to any unauthorized accessory.
Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
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CAUTIONS Caution: During use, the AC connector needs to be easily accessible. In case of emergency, remove the power cord as soon as possible.
Caution: To avoid unnecessary strain on the user, use the device in manner that is comfortable.
Caution: Do not force connections; improper installation may damage the connector or display.
Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may damage the device. Refer to the “Cleaning the Equipment” section. Caution: Use only approved or recommended cleaners or disinfectants to avoid damaging the equipment. Caution: Do not attempt to sterilize the Site~Rite Vision* II Ultrasound System; damage to the equipment may occur as a result. Caution: When attaching the display to the roll stand, do not over--tighten the screws; doing so may damage the display. Caution: Use only the screws provided in the packaging. Ensure the unit is secure against the roll--stand mount. Failure to do so may cause the display to disconnect from the roll--stand mount. Caution: The Site~Rite Vision* II Ultrasound System contains an internal battery. Always properly 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 display, AC adapter, connectors, or ports; damage to the equipment may occur. Caution: Only qualified personnel should attempt to service this equipment. The Site~Rite Vision* II Ultrasound System contains static sensitive components and circuits. Failure to observe proper static-- control procedures may result in damage to the system.
Caution: Hot water (in excess of 113 °F or 45 °C) may damage the system.
Caution: To avoid damage to the device operating system, shutdown the device through the power control window. 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 Vision* II Ultrasound System acoustic--output 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
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medical practitioner should limit the time of patient exposure to ultrasonic radiation using the principles of ALARA. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Caution: Do not pull the cable to disconnect the probe connector from the display; doing so may damage the cable, cable connection, and/or display. Caution: Cardiac--rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been observed in the diagnostic range of Mechanical Index (MI) values. Caution: Do not twist or bend the probe cable in excess of that required during normal use of the probe. Excessively twisting or bending the cable may cause equipment failure, intermittent operation, or unpredictable operation. Caution: When disinfecting the probe with a liquid disinfectant, do not soak the probe cable, cable bend relief, probe connector, 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 do not contain latex.
Caution: Do not force the probe connector; damage to the connector and system could result.
Caution: Always snap the needle guides on the probe hook. Do not slide the needle guide onto the needle--guide hook, as the sterile sheath may tear. Caution: Do not subject the probe to excessive vibration; 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 display may occur. Caution: Hot water (in excess of 113 °F or 45 °C) may damage the probe.
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Caution: Use only Bard Access Systems cleaning and disinfection procedures; failure to do so may damage the device. Caution: Avoid subjecting the probe to excessive mechanical shock; damage to the probe may occur as a result. Caution: Do not attempt to sterilize the Site~Rite Vision* II Ultrasound System display or probes; damage to the equipment may occur as a result. Caution: Do not use the probe with high--frequency surgical equipment; doing so may damage the Site~Rite Vision* II Ultrasound System.
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DISPLAY SCREEN & ICONS Display Screen The display screen is the main interface of the software, which you will see after opening the program. This screen contains various icons that provide information and enable various features. An explanation of the various parts of the screen is provided below.
Probe--orientation indicator
Information bar
--Procedure template in use
--Image preset in use
Imaging toolbar
Focus indicator Vertical scale Horizontal scale
Feature toolbar
Level 2 controls
Level 3 controls
Virtual keyboard
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Information Bar Battery life/power indicator
Date & time
Patient ID & patient name
Software version & probe type
Battery Life The following table details the status of the battery corresponding to the image shown on the display screen:
The icon of a battery full of green bars indicates that 81%–100% of the battery’s power remains.
The icon of a battery not quite full of green bars indicates that 61%–80% of the battery’s power remains.
The icon of a battery approximately half full of green bars indicates that 41%– 60% of the battery’s power remains.
The icon of a battery with yellow bars at the bottom indicates that 21%–40% of the battery’s power remains.
The icon of a battery with a blinking red bar indicates that 0%–20% of the battery’s power remains. In this case, connect the system to AC power to continue to operate it and/or recharge the battery. While the system charges, the icon of the battery will progressively be filled with green bars until it reaches 100% battery power.
The icon of a battery with a red exclamation point indicates a battery error. In this case, refer to the section of this IFU regarding troubleshooting errors.
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Power Indicators The following table details the on/off status corresponding to the icon shown on the display screen: The icon of a battery without black AC plug indicates that the system is not connected to AC power.
The icon of a battery with black AC plug indicates that the system is connected to AC power.
Power--Control Window The follow icons appear when the power button is pressed while power is already on:
Stand By
Shut Down
Restart
Cancel
Information--Bar Icons The icons below are located underneath the battery--life icon at the top left corner of the screen. Selecting any of these buttons above will open system settings. An X on the icon indicates that function is not operational.
Network Indicates that the system is connected to a wired network
Site~Rite Vision* II Ultrasound System
Audio Indicates that the Audio is on
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Imaging Toolbar Icon
Description
Auto -- Adjusts image controls to automatically correct image quality
Depth -- Adjusts depth Overall Gain -- Adjusts overall image gain
Focus -- Adjusts focal depth. When focus exceeds image depth, a red arrow will appear in the bottom left corner of the imaging area. Note: Adjust the focal indicator to the area of interest
Freeze -- Freezes or unfreezes the image Print/Save -- Saves the image to the database and USB drive (if attached) and prints (if the system is connected to a printer)
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