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USER’S MANUAL

3

CAUTION: In the United States, federal law restricts this device 

to use by, or on the order of, a physician.

© 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.

USER’S MANUAL

Summary of Contents for Accuro

Page 1: ...USER S MANUAL 735 00005 Rev Q Pocket sized ultrasound device for spinal and epidural anesthesia guidance ...

Page 2: ...sons is strictly prohibited THIS DOCUMENT IS PROVIDED WITHOUT WARRANTY OF ANY KIND IMPLIED OR EXPRESSED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE RIVANNA shall in no event be liable for incidental or consequential damages resulting from the use of Accuro Some states do not allow the exclusion of incidental or consequential damages s...

Page 3: ...USER S MANUAL 3 USER S MANUAL ...

Page 4: ...ccuro 16 Using SpineNav3D to guide epidural and spinal anesthesia 16 Generate exam reports and or save exam images to an external computer 17 Check for software upgrades 17 Accuro maintenance 18 Instrument care and maintenance inspection 18 Cleaning and disinfection 18 Cleaning procedure 18 Disinfecting procedures 18 Electromagnetic compatibility EMC 19 Electromagnetic emissions 19 Electromagnetic...

Page 5: ... plane orientation in 3D SpineNav3D technology makes image interpretation and measurements of the lumbar and thoracic spine anatomy simple quick and easy A sonographer is not required to use the LUMBAR or THORACIC presets Real time 2D scans from either LUMBAR THORACIC or BONE presets are formed using proprietary BoneEnhance technology The BoneEnhance technology provides images of bone anatomy at g...

Page 6: ...charger must be minimally certified to EN IEC 60601 1 system standard CAUTION Damage to the instrument may occur Only apply commercially available ultrasonic couplant which has been specifically formulated for use in medical applications to the acoustic window or face of the probe Failure to do so may cause damage to the Accuro instrument CAUTION Damage to the instrument may occur Do not attempt t...

Page 7: ...ll charger to the Accuro Micro USB to USB cable screen mirror Connects the Accuro to external display screen 10ft Allows screen mirror functionality Battery charger components Accessories PART NAME DESCRIPTION Acoustic coupling gel Travel sized ultrasound coupling gel Carrying case Transports Accuro and accessories ROTATING TOUCHSCREEN DISPLAY POWER IMAGE CAPTURE MICRO USB DISPLAY ROTATION HINGE U...

Page 8: ...d the length of the button hold Home screen The HOME screen appears when the Accuro is first powered on The HOME screen serves as a starting point for all the main functions of the Accuro BUTTON OR INDICATOR FUNCTION Press to go to LUMBAR imaging preset using SpineNav3D automation Press to go to THORACIC imaging preset using SpineNav3D automation Press to go to BONE or TISSUE imaging presets Press...

Page 9: ...ssue signal brightness only Press to save the current image on the screen The saved image will be stored in the GALLERY and associated with the current exam This button is present after the pause button is pressed Press to save a video of the previous 4 seconds The saved video will be stored in the GALLERY and associated with the current exam This button is present after the pause button is presse...

Page 10: ...e 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 Transparency indicates algorithmic confidence of correct sp...

Page 11: ...s process position detection Press to go back to HOME screen Press to pause current imaging session Press to resume imaging session This button replaces the pause button after pause button is pressed Press up or down arrow to increase or decrease imaging depth Press up or down arrow to increase or decrease image brightness The brightness control is used to increase or decrease the tissue signal br...

Page 12: ...e Indicates the available mmc storage space Gallery image selection screen The GALLERY image selection screen appears after you press the VIEW IMAGE GALLERY icon from the HOME screen and then select an Exam from the GALLERY main screen BUTTON OR INDICATOR FUNCTION 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 Press to select ...

Page 13: ...BUTTON OR INDICATOR FUNCTION Press to go back to GALLERY image selection screen Press to export current image as png file Press to go to the exam info page where patient information and exam information is entered Press to start resume video playback Press to pause video playback Press to export current cine as avi file Video playback progression indicator BACK EXAM PATIENT INFORMATION EXPORT IMAG...

Page 14: ...reen Press to power off the device Press to go to the settings main menu Displays Controls and Indicators Settings screen The SETTINGS screen appears after you press the SETTINGS icon from the HOME screen Swipe up or down to display more settings items ...

Page 15: ... thoracic needle track indicator display Press to select desired screen orientation Press to choose USB connection functionality Press to choose between video or still image action for physical button quick press Press to set time before device automatically goes to sleep Press to toggle device password protection on off and set password Press for option to perform a factory reset Factory reset wi...

Page 16: ...k and easy A sonographer is not required to use the LUMBAR or THORACIC presets To perform a clinical lumbar or thoracic epidural or related spinal anesthesia procedure 1 Turn on the Accuro by pressing the power on off button 2 Place the Accuro in a sterile cover and administer the Accuro Locator needle guide sold separately 3 Select the LUMBAR or THORACIC imaging preset for neuraxial anesthesia gu...

Page 17: ... SCREEN MIRROR 2 Connect Accuro to an external computer 3 Start the camera application on the external computer Minimum system requirements Note Connection to an external computer should occur outside of the patient environment unless computer equipment is certified to IEC 60601 1 Computer operating system Microsoft Windows 10 Minimum processor 1 GHz Minimum RAM 1 GB Minimum display 1024 x 768 Che...

Page 18: ...uro instrument should be cleaned between patient uses To clean the Accuro probes follow these instructions Turn off the Accuro system Dampen a nonabrasive cloth with isopropyl alcohol and wipe the probe until thoroughly cleaned Gently wipe the dampened cloth over exterior surfaces requiring cleaning Wipe with a dry cloth Disinfecting procedures If the instrument needs to be disinfected use a dampe...

Page 19: ...Evidence of disruption may include image degradation or distortion erratic readings self reset equipment ceasing to operate unexpected shutdown or other incorrect functioning If this occurs survey the site to determine the source of disruption and take the following actions to eliminate the source s Turn on the Accuro by pressing the power on off button and verify that Accuro operates as intended ...

Page 20: ...mpliance Surge IEC 61000 4 5 0 5 kV 1 kV Line to line 0 5 kV 1 kV 2 kV Line to earth In compliance Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Voltage dips 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions 0 UT 250 300 cycle Immunity Power Frequency 50 60 Hz magnetic f...

Page 21: ...he equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from stru...

Page 22: ...the most part control it The ability to limit exposure over time supports the ALARA principle Applying ALARA The system imaging mode selected by the user is determined by the diagnostic information required B mode imaging provides anatomical information and Tissue Harmonic Imaging which uses higher received frequencies provides less image clutter artifact and improves the overall resolution of the...

Page 23: ...orage conditions Probe specifications Acoustic output specifications See summary of acoustic quantities on the following page Battery specifications The Accuro contains a Lithium Ion battery that is permanently enclosed in the instrument unit The battery is not replaceable A battery icon is located on the instrument upper right display and indicates the current charge level and when recharging is ...

Page 24: ...ded regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses Note 3 Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in 51 2 aa and 51 2 dd a Intended use does not include cephalic so TIC is not computed No data reported Summary of acoustic quantities Transducer Model Accuro Operating Mode B Mode ...

Page 25: ...ure 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 Symbols ...

Page 26: ...le VA 22902 USA T 800 645 7508 www rivannamedical com info rivannamedical com 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 ...

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