Summary of Contents for RIVANNA Accuro
- Page 1 Pocket-sized ultrasound device for spinal and epidural anesthesia guidance. USER’S MANUAL 735-00005 Rev Q...
- Page 2 © Copyright, Rivanna Medical, LLC, all rights reserved. Unauthorized copying of this document, in addition to infringing copyright, might reduce the ability of RIVANNA to provide accurate and current information to users.
- Page 3 USER’S MANUAL USER’S MANUAL...
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Page 4: Table Of Contents
Warnings and cautions ............5 ALARA Principle ..............22 WARNINGS ...............6 Applying ALARA ..............22 CAUTIONS .................6 Direct controls ..............22 Introducing the Accuro ............7 Indirect controls ..............22 Instrument parts and features ..........7 Receiver controls ...............22 Components ................7 Other technical specifications ..........23 Battery charger components ..........7 Instrument specifications ..........23... -
Page 5: Important Information
BoneEnhance technology. The exported to a computer for storage Warnings and cautions BoneEnhance technology provides or printing. The Accuro should only be used by images of bone anatomy at greater trained individuals who have been bone-to-tissue contrast compared Principles of operation authorized by a physician. -
Page 6: Warnings
The Accuro may contain mineral oils, batteries, and other environmentally The images and calculations provided If you use the Accuro in the presence hazardous materials. When the Accuro by the Accuro instrument are intended of flammable anesthetics, the hazard... -
Page 7: Introducing The Accuro
Charges the battery inside the Accuro. Micro-USB to USB cable (charging cable) Connects the USB wall charger to the Accuro. Micro-USB to USB cable (screen mirror) Connects the Accuro to external display screen (10ft) Allows screen mirror functionality. Accessories PART NAME... -
Page 8: Displays, Controls, And Indicators
Home screen The HOME screen appears when the Accuro is first powered on. The HOME screen serves as a starting Press to go to BONE or TISSUE point for all the main functions of the imaging presets. -
Page 9: Bone And Tissue Preset Scanning Screen
Displays, Controls, and Indicators BONE and TISSUE preset scanning screen The BONE or TISSUE scanning screen appears after you press the BONE or TISSUE button from the HOME screen. LIVE IMAGING PAUSED BACK BACK STILL-IMAGE CAPTURE PAUSE PLAY VIDEO CAPTURE DEPTH CONTRAST CONTROLS... -
Page 10: Lumbar And Thoracic Preset Scanning Screen
3D navigation spine in the bottom image panel. Indicator in the top panel of the THORACIC preset screen that identifies a prescribed needle path based on the Accuro Locator needle guide (sold separately). The indicator is present when the paramedian needle path intersects a location adjacent to the spinous process but within the width of the interlaminar space, and at the depth of the interlaminar space. - Page 11 Displays, Controls, and Indicators BUTTON OR FUNCTION INDICATOR Indicator in the bottom panel of the LUMBAR preset screen that illustrates the position and orientation of the current 2D scan plane along a 3D spine reconstruction. The 3D spine possesses a transparency that indicates algorithmic confidence of correct spinal position detection.
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Page 12: Gallery Main Screen
Displays, Controls, and Indicators Gallery main screen BUTTON OR FUNCTION The GALLERY screen appears after you INDICATOR press the VIEW EXAM GALLERY icon from the HOME screen. Press to go to HOME screen. Press to go to HOME screen. Press to power off the device. Press to go to the SETTINGS screen. -
Page 13: Gallery Video Playback Screen
Displays, Controls, and Indicators Gallery video playback screen The gallery video playback screen appears after you press the GALLERY icon from the HOME screen, then select an Exam from the GALLERY main screen, and select a file with a ‘cine’ prefix. BACK BACK EXPORT IMAGE... -
Page 14: Settings Screen
Displays, Controls, and Indicators Settings screen The SETTINGS screen appears after you press the SETTINGS icon from the HOME screen. BUTTON/ FUNCTION INDICATOR Press to go to HOME screen. Press to power off the device. Press to go to the settings main menu. Swipe up or down to display more settings items. - Page 15 Press to set the date. Press to set the time. Press to set the institution name. Press to enter code provided by RIVANNA to unlock features. Press for further options to perform system diagnosis and repair. Toggle control to customize lumbar display.
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Page 16: Using The Accuro
Using SpineNav3D to guide epidural and spinal anesthesia The Accuro LUMBAR and THORACIC presets use ultrasonic reflections acquired from multiple scan planes to obtain 3D volume scans of the lumbar and thoracic spine. The SpineNav3D technology facilitates image interpretation of individual 2D lumbar and thoracic spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. -
Page 17: Generate Exam Reports And/Or Save Exam Images To An External Computer
2. Connect Accuro to an external to IEC 60601-1 computer. 1. For best results, shut down Accuro and connect the Accuro to an Computer operating system – Microsoft 3. Start the camera application on the external computer using the micro- Windows®... -
Page 18: Accuro Maintenance
The to every use of the instrument. clean the Accuro probes, follow instrument should be wiped until Stop using the Accuro if damage is these instructions: thoroughly cleaned. noted. Failure to do so may result in electrical shock or fire. -
Page 19: Electromagnetic Compatibility (Emc)
Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Accuro is intended for use in the electromagnetic environment specified below. The customer or the user of the Accuro should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment —... -
Page 20: Electromagnetic Immunity
Electromagnetic Compatibility (EMC) Electromagnetic Immunity The Accuro is intended for use in the electromagnetic environment specified below. The customer or the user of the Accuro should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level... - Page 21 Recommended separation distances between portable and mobile RF communications equipment and Accuro. The Accuro is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Accuro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Accuro as recommended below, according to the maximum output power of the communications equipment.
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Page 22: Alara Principle
ALARA is the guiding principle for the useful variable because the qualified safe use of diagnostic ultrasound. user can, for the most part, control The Accuro system does not contain Sonographers and other qualified it. The ability to limit exposure over any controls that directly affect ultrasound users, using good time supports the ALARA principle. -
Page 23: Other Technical Specifications
0.31 kg (0.7 lb) Display type 48.96 mm x 73.44 mm (480 pixels x 320 pixels, 166 dpi) Operating and storage conditions The Accuro is designed to function under the following operating and storage conditions: Condition Description Storage temperature -10°C - 50°C... -
Page 24: Summary Of Acoustic Quantities
Other Technical Specifications Summary of acoustic quantities Transducer Model: Accuro Operating Mode: B-Mode Note 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode. Note 2: Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses. -
Page 25: Accuro Safety
Safety Symbols SYMBOL DEFINITION Type BF applied part Manufacture date Manufacturer of product Follow Instructions For Use (IFU) Serial number Degree of protection against harmful ingress of water Dispose of product in accordance with Directive 2012/19/EU TUV Rheinland Nationally Recognized Testing Laboratory (NRTL) certification USER’S MANUAL... - Page 26 USER’S MANUAL © Copyright, Rivanna Medical, LLC, all rights reserved. Unauthorized copying of this document, in addition to infringing copyright, might reduce the ability of RIVANNA to provide accurate and current information to users. Contact Information: Rivanna Medical, LLC 109 E Water Street...
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