RIVANNA Accuro User manual
USER’S MANUAL
735-00005 Rev Q
Pocket-sized ultrasound device for spinal and epidural anesthesia guidance.
2
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.
RIVANNA®, Accuro®, BoneEnhance®,
and SpineNav3D™ are trademarks of
Rivanna Medical, LLC.
Cidex®is a registered trademark of
Aprorocidin International.
The Accuro ultrasound system
referenced in this document is covered
by US and International Patents and
Pending Patents. See
www.rivannamedical.com/patents/.
This document and the information
contained in it is proprietary and
condential information of Rivanna
Medical, LLC (“RIVANNA”) and may not
be reproduced, copied in whole or in
part, adapted, modied, disclosed to
others, or disseminated without the
prior written permission of RIVANNA.
This document is intended to be used
either by customers, and is licensed
to them as part of their RIVANNA
equipment purchase, or to meet
regulatory commitments as required
by the FDA and other local regulatory
requirements. Use or dissemination
of this document by unauthorized
persons 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
so this exclusion may not apply to you.
RIVANNA has taken care to ensure the
accuracy of this document. However,
RIVANNA assumes no liability for errors
or omissions and reserves the right to
make changes without further notice
to any products herein to improve
reliability, function, or design. RIVANNA
may make improvements or changes
in the products or programs described
in this document at any time without
prior notice. CONTACT YOUR RIVANNA
REPRESENTATIVE FOR UP-TO-DATE
DOCUMENTATION. All information in
this User’s Manual may change at any
time without notice.
For the most up-to-date information,
see the online manuals at
rivannamedical.com. Examples
provided by RIVANNA in this User’s
Manual do not in any way represent
real patient or exam data.
Contact Information:
Rivanna Medical, LLC
109 E Water Street
Charlottesville, VA 22902, USA
T: 800-645-7508
www.rivannamedical.com
MDSS GmbH
Schigraben 41
30175 Hannover
Germany
1434
735-00005 Rev Q – 12/01/2020
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
4
Table of contents ....................................................................4
Important information ...........................................................5
Product description ............................................................5
Principles of operation .......................................................5
Indications for use ..............................................................5
Essential Performance........................................................5
Contraindications................................................................5
Statement of prescription..................................................5
Warnings and cautions.......................................................5
WARNINGS .......................................................................6
CAUTIONS.........................................................................6
Introducing the Accuro...........................................................7
Instrument parts and features ..........................................7
Components............................................................................7
Battery charger components.............................................7
Accessories ..........................................................................7
Displays, controls, and indicators.........................................8
Console display and functions ..........................................8
Home screen........................................................................8
BONE and TISSUE preset scanning screen ......................9
LUMBAR and THORACIC preset scanning screen...........10
Gallery main screen ..........................................................12
Gallery video playback screen .........................................13
Settings screen ..................................................................14
Using the Accuro...................................................................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 immunity...............................................20
ALARA Principle.....................................................................22
Applying ALARA .................................................................22
Direct controls ...................................................................22
Indirect controls ................................................................22
Receiver controls...............................................................22
Other technical specications .............................................23
Instrument specications.................................................23
Operating and storage conditions ..................................23
Probe specications..........................................................23
Acoustic output specications.........................................23
Battery specications .......................................................23
Accuracy statement ..........................................................23
Summary of acoustic quantities......................................24
Accuro safety .........................................................................25
Symbols ..............................................................................25
Table of Contents
Accuro
USER’S MANUAL 5
Product description
The Accuro is a pocket-sized and
battery operated ultrasound
instrument. The device is a single
self-contained unit consisting of
an ultrasound system, ultrasound
probe, and rotatable touchscreen
display. The instrument provides
LUMBAR and THORACIC presets
to facilitate epidural and spinal
anesthesia imaging guidance
with real-time 3D navigation of
the lumbar or thoracic spine. The
LUMBAR and THORACIC presets
use proprietary technology, called
SpineNav3D, to automate spinal
bone landmark detection and depth
measurements and to assess real-
time scan plane orientation in 3D.
Accuro ultrasound scans and
measurements can be saved in an
examination le on the device and
exported to a computer for storage
or printing.
Principles of operation
Medical ultrasound imaging uses
an ultrasound transducer, which
transmits and receives high
frequency mechanical waves. The
transmitted ultrasound waves
reect o of structures in the body
that exhibit changes in acoustic
impedance. A portion of the
reected ultrasound energy returns
to the ultrasound transducer and
is converted back into an electrical
signal, which is then amplied,
digitized, and processed through a
series of lters. The digital signal is
transformed into an image that can
be saved in memory and displayed
to the display screen in real-time.
The SpineNav3D feature has only
been clinically validated in the
lumbar and thoracic spine analysis
of obese and non-obese patients
and not in any other areas of the
spine or in case of spinal deformities,
signicant spinal degeneration,
previous spinal surgeries, etc.
The Accuro LUMBAR and THORACIC
presets use ultrasonic reections
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. 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 greater
bone-to-tissue contrast compared
with conventional ultrasound image
reconstructions.
Indications for use
The Accuro ultrasound scanner is
intended for diagnostic ultrasound
imaging of the human body in the
following clinical applications:
USA only
• Abdominal
• Cardiac
• Musculoskeletal (Conventional)
• Musculoskeletal (Supercial)
• Pediatric
• Small Organ
• Peripheral vessel
Non-USA only
• Abdominal
• Cardiac
• Musculoskeletal (Conventional)
• Musculoskeletal (Supercial)
• Peripheral vessel
Essential performance
The essential performance of the
Accuro consists of ultrasonic image
display of the dimension and
location of spinal anatomy, display
of ultrasound indexes pertaining
to safety related indications,
and prevention of unintended
or excessive ultrasound output
and transducer assembly surface
temperature.
Contraindications
The Accuro ultrasound instrument is
not intended for ophthalmic use or
any use causing the acoustic beam
to pass through the eye.
Statement of prescription
United States law restricts this device
to sale or use by, or on the order of,
a physician.
Warnings and cautions
The Accuro should only be used by
trained individuals who have been
authorized by a physician. All users
must read the entire User’s Manual
prior to using the Accuro. To prevent
damage of the equipment or injury
to yourself or others, carefully
read the following warnings and
cautions before using the Accuro.
Rivanna Medical, LLC disclaims all
responsibility and liability for the
operating safety, reliability, and
performance of the Accuro if the
warnings and cautions disclosed in
this User’s Manual are disregarded in
any way.
The Accuro has not been evaluated
for use with high frequency (HF)
surgical equipment.
A typical examination using the
Accuro is guidance of neuraxial
anesthesia.
Important Information
6
Important Information
WARNINGS
WARNING! Risk of explosion, re, or
serious injury
If you use the Accuro in the presence
of ammable anesthetics, the hazard
of potential explosion exists.
Do not place the Accuro near a heat
source or expose it to direct ame.
Such exposure may lead to corrosive
liquid leakage, electrical shock, or re.
Stop using the Accuro if the casing is
damaged. Failure to do so may result
in electrical shock or re.
Electrical shock may result from
using damaged USB cables with the
Accuro or if modications are made
to the Accuro by anyone other than
personnel authorized by RIVANNA.
Only use RIVANNA approved cables
with the Accuro.
Avoid dropping or subjecting the
Accuro to severe impacts. This could
result in electrical shock, corrosive
liquid leakage, and injury.
If battery leakage is present, wear
protective gloves and discard the
Accuro immediately following
applicable regulations.
WARNING! Potential patient hazard
Do not use the Accuro instrument for
ophthalmic indications.Ophthalmic use
may cause patient injury.
CAUTIONS
CAUTION: Potential patient hazard
from acoustic exposure
To date, exposure to diagnostic
medical ultrasound has not
been shown to produce adverse
health eects. However, medical
professionals should use ultrasound
only when clinically indicated.
Medical professionals should use the
lowest exposure times possible. The
ultrasound output of the Accuro is not
user-adjustable and is limited to the
minimum level necessary for eective
performance.
CAUTION: Hazardous materials
present. Assure proper disposal.
The Accuro may contain mineral oils,
batteries, and other environmentally
hazardous materials. When the Accuro
has reached the end of its useful
service, follow your local protocols for
hazardous waste disposal.
CAUTION: Assure proper distance
from patient
When transmitting data to or from
your computer, make sure that the
Accuro, accessories, and the computer
are outside of the patient vicinity
(more than six feet from the patient).
CAUTION: Assure proper computer
system and/or printer conguration
When using the Accuro with an
external computer system and/or
printer unit, the computer system
and/or printer unit or a charger, the
computer system and/or printer unit
or charger must be minimally certied
to EN/IEC 60601-1 system standard.
CAUTION: Damage to the
instrument may occur
Only apply commercially available
ultrasonic couplant, which has been
specically 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 to sterilize the Accuro
instrument. Damage to the Accuro
instrument may occur.
CAUTION: Damage to the
instrument may occur
Hot water in excess of 113°F or 45°C
may damage the instrument.
CAUTION: Damage to the
instrument may occur
Do not immerse the instrument in
disinfectant solution.
CAUTION: Images and calculations
are not to be used as the sole basis
for clinical diagnosis
The images and calculations provided
by the Accuro instrument are intended
for use by competent users, as a
diagnostic tool. They are explicitly
not to be used as the sole, irrefutable
basis for clinical diagnosis. Users are
encouraged to account for the clinical
utility of the Accuro and make their
own professional conclusions.
CAUTION: Risk of inaccurate
measurements
The images and calculations provided
by the Accuro instrument are intended
for use by competent users, as a
diagnostic tool. The user should be
aware of the instrument specications,
accuracy, and limitations. These
limitations must be considered before
making any decision based on images
and quantitative values.
Incorrect image settings, equipment
malfunction, or failure to correctly
operate the Accuro can result in
measurement errors or failure to
detect certain details in the image.
The user must be thoroughly familiar
with the operation of the Accuro in
order to optimize its performance and
to recognize possible malfunctions
and limitations. Application training
is available through the sales
representative.
CAUTION: Ensure security of
protected health information
Protected health Information (PHI)
such as personal identiers can
be manually entered on Accuro
to associate with image data. To
best secure PHI during storage and
transfer, it is recommended to always
use password protection and maintain
anonymous image les. Both can be
congured from the SETTINGS screen.
If Accuro needs to be transported for
repair, ensure that all patient data is
backed up and conrm that backup
was successful. All patient data must
be erased from internal memory of
Accuro before shipment.
USER’S MANUAL 7
Introducing the Accuro
Instrument parts and features
Components
PART NAME DESCRIPTION
USB wall charger 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.
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
ULTRASOUND PROBE
8
Displays, Controls, and Indicators
Console display
and functions
The Accuro console consists of
an LCD touchscreen display and
a single power button. The LCD
display presents a combination of
user information, scan displays, and
prompts, which vary depending on
the current device function.
The power button has the function
of either powering on/o the device,
putting the device in sleep mode,
or saving images. The functionality
depends on the state of the device,
such as the current screen, and the
length of the button hold.
Home screen
The HOME screen appears when
the Accuro is rst 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 to go to the
GALLERY main menu screen.
Press to access the
Accuro HELP screen.
Press to power o the device.
Press to go to the
SETTINGS screen.
Indicates the current
battery charge.
Indicates the available
mmc storage space.
Blue LED indicates power on.
Orange LED indicates battery is
charging.
USER’S MANUAL 9
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.
BUTTON OR
INDICATOR
FUNCTION
Press to go back to HOME screen.
Press to pause current imaging session.
Press to resume imaging session. This button replaces pause button after pause button is pressed.
Press to toggle quick zoom. Quick zoom will increase resolution and decrease imaging depth.
Press up or down arrow to increase or decrease imaging depth.
Press up or down arrow to increase or decrease image brightness. In the BONE imaging preset,
brightness controls are used to increase or decrease the tissue 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 pressed.
Press to go to the exam information page to enter patient and exam information.
Press the physical device button to save the current image to the current exam during live imaging.
This button can save either still-image or video capture depending on the user’s settings.
Displays, Controls, and Indicators
CONTRAST
CONTROLS
DEPTH
CONTROLS
BACK
PAUSE
BACK
PLAY
EXAM/PATIENT
INFORMATION
STILL-IMAGE
CAPTURE
VIDEO
CAPTURE
MAXIMUM
DEPTH
INDICATOR
LIVE IMAGING PAUSED
10
Displays, Controls, and Indicators
BUTTON OR INDICATOR FUNCTION
Indicator in the top panel of the LUMBAR preset screen that automatically
identies the presence and location of either interlaminar space or spinous
process cross-sections within the 2D scan.
The cross-section overlay is orange when interlaminar space is identied
and blue when spinous process is identied.
The cross-section overlay possesses a transparency that indicates
algorithmic condence of correct interlaminar space or spinous process
identication. A less transparent overlay indicates high condence in
anatomy detection while more transparency indicates less condence. The
transparency of the overlay matches that of the 3D navigation spine in the
bottom image panel.
Indicator in the top panel of the THORACIC preset screen that identies 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 condence of correct spinous process
and interlaminar depth identications.
10.25.15 12:45:28 P
SPINE: 02 TI: 1.0 MI: 1.2
5
5
61
0
SPINOUS PROCESS
DEPTH ESTIMATE
BACK
PAUSE
MAXIMUM DEPTH
INDICATOR
SPINAL CROSS
SECTION
IDENTIFICATION
SCAN PLANE
ORIENTATION
ALONG 3D SPINE
INTERLAMINAR
SPACE DEPTH
ESTIMATE
3D NAVIGATION SPINE
MAXIMUM DEPTH
INDICATOR
BACK
PAUSE
INTERLAMINAR
SPACE DEPTH
ESTIMATE
LUMBAR and THORACIC preset scanning screen
The LUMBAR or THORACIC screen appears after you press the LUMBAR or THORACIC button from
the HOME screen.
LUMBAR PRESET THORACIC PRESET
NEEDLE-TRACK
INDICATOR
USER’S MANUAL 11
Displays, Controls, and Indicators Displays, Controls, and Indicators
BUTTON OR
INDICATOR
FUNCTION
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 condence of correct spinal
position detection. A less transparent 3D spine indicates high condence in position and scan
plane orientation while more transparency indicates less condence. The transparency of the
3D navigation spine overlay matches that of the cross-section overlay in the top image panel.
Indicator along the right of the display that automatically detects the depths of the
interlaminar space and spinous process depths. Interlaminar space is indicated with orange
text while spinous process is indicated with blue text.
The depth indicator possesses a transparency that indicates algorithmic condence of correct
interlaminar space or spinous 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 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 last 4 seconds before the imaging session was paused. The saved
video will be stored in the GALLERY and associated with the current exam. This button is pres-
ent after the pause button is pressed.
Press to go to the exam information page where patient information and exam information is
entered.
Press the physical device button to save the current image to the current Exam. This button
can save either still-image or video capture depending on user’s preference. To toggle between
still-image and video capture go to HOME->SETTINGS->Physical Button.
12
Displays, Controls, and Indicators
Gallery main screen
The GALLERY screen appears after you
press the VIEW EXAM GALLERY icon from
the HOME screen.
BUTTON OR
INDICATOR
FUNCTION
Press to go to HOME screen.
Press to go to HOME screen.
Press to power o the device.
Press to go to the SETTINGS screen.
Press to select exam(s) for deletion.
Indicates the current battery charge.
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 o the device.
Press to go to the SETTINGS screen.
Press to select exam(s) for deletion.
Indicates the current battery charge.
Indicates the available mmc storage
space.
Press to go to the exam info page
where patient information and exam
USER’S MANUAL 13
Displays, Controls, and Indicators 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 le with a ‘cine’ prex.
BUTTON OR INDICATOR FUNCTION
Press to go back to GALLERY image selection screen.
Press to export current image as ‘.png’ le.
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’ le.
Video playback progression indicator.
BACK
EXAM/PATIENT
INFORMATION
EXPORT IMAGE
AS PNG
PLAY
EXPORT CINE
AS AVI
BACK
PAUSE
VIDEO PLAYBACK
FRAME
14
BUTTON/
INDICATOR
FUNCTION
Press to go to HOME screen.
Press to power o 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.
USER’S MANUAL 15
Displays, Controls, and Indicators Displays, Controls, and Indicators
BUTTON/
INDICATOR FUNCTION
Press to set language.
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.
Press to customize 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/o and set password.
Press for option to perform a factory reset. Factory reset will restore device
to default conditions.
Press to toggle whether or not patient information will be included on saved image.
Press for more information about Accuro.
16
Using the Accuro
Using SpineNav3D to guide epidural and spinal anesthesia
The Accuro LUMBAR and THORACIC presets use ultrasonic reections 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. 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.
To perform a clinical lumbar or thoracic epidural or related spinal anesthesia procedure:
1. Turn on the Accuro by pressing
the power on/o 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 guidance
with SpineNav3D.
4. The micro-USB port is used for
charging and image export to
a computer.
5. Power o the Accuro by
pressing the power icon from
the Accuro HOME screen.
POWER ON
SELECT LUMBAR OR
THORACIC IMAGING PRESET
1.
3.
LOCATOR™
2.
MICRO-USB
4.
POWER OFF
5.
CAUTION: For accurate imaging results, SpineNav3D must be performed in the lumbar or thoracic region with a
transverse scan plane orientation.
USER’S MANUAL 17
Using the Accuro Using the Accuro
Generate exam reports and/
or save exam images to an
external computer
To annotate, generate exam reports,
or save exam images to an external
computer:
1. For best results, shut down
Accuro and connect the Accuro to an
external computer using the micro-
USB cable provided with Accuro
2. Restart Accuro while connected
3. Find the ATLAS drive on the
external computer and run the
AccuroATLAS application to enable
image annotation, generation of
exam reports, and/or saving of exam
images.
Using screen mirror
To use screen mirror function:
1. Go to SETTINGS -> USB Mode, select
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 certied
to IEC 60601-1
Computer operating system – Microsoft
Windows® 10
Minimum processor – 1 GHz
Minimum RAM - 1 GB
Minimum display – 1024 x 768
Check for software
upgrades
To check for software upgrades:
1. Run AccuroATLAS application
and select Help -> Update
2. Follow the instructions to check
availability of software upgrades
CAUTION: Assure proper
distance from patient.
When transmitting data to or
from your computer, make sure
that the Accuro, accessories,
and the computer are outside
of the patient vicinity (more
than six feet from the patient).
18
Accuro Maintenance
Instrument care and
maintenance inspection
The Accuro should be inspected for
physical damage and cracks prior
to every use of the instrument.
Stop using the Accuro if damage is
noted. Failure to do so may result in
electrical shock or re.
Other than the routine inspection
and cleaning described in this User’s
Manual, there is no periodic or
preventive maintenance required for
Accuro. There are no components
that require periodic testing
or calibration for performance
assurance.
Cleaning and disinfection
Cleaning procedure
The Accuro instrument should be
cleaned between patient uses. To
clean the Accuro probes, follow
these instructions:
Turn o 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 dampened
nonabrasive cloth with an approved
disinfecting agent or wipe. The
instrument should be wiped until
thoroughly cleaned.
Contact RIVANNA for a list of
approved disinfectants and
disinfecting wipes.
CAUTION: Damage to the
instrument may occur
Do not immerse the instrument in
disinfectant solution.
Use cleaning and disinfecting
procedures as described above.
USER’S MANUAL 19
Accuro Maintenance Electromagnetic Compatibility (EMC)
The Accuro has been designed and
tested and found to comply with the
electromagnetic compatibility (EMC)
limits for medical devices to the EN/
IEC 60601-1-2 standard for EMC.
These limits are designed to provide
reasonable protection against
harmful interference in a typical
medical installation.
WARNING: Use of the Accuro
adjacent to or stacked with other
equipment should be avoided
because it could result in improper
operation. If such use is necessary,
this equipment and the other
equipment should be observed
to verify that they are operating
normally.
WARNING: Use of accessories,
transducers and cables other than
those specied or provided by
RIVANNA could result in increased
electromagnetic emissions or
decreased electromagnetic immunity
of this equipment and result in
improper operation.
CAUTION: Medical electrical
equipment requires special
precautions regarding EMC and
must be installed and operated
according to these instructions. It is
possible that high levels of radiated
or conducted radio-frequency
electromagnetic interference
(EMI) from portable or mobile RF
communications equipment or other
strong or nearby radio-frequency
sources, could result in performance
disruption of the ultrasound
system. 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/o button and
verify that Accuro operates as
intended.
• Turn equipment in the vicinity
o and on to isolate the source.
• Relocate or re-orient the
interfering source.
• Increase distance between
source and the ultrasound unit.
• Educate clinical sta to
recognize potential EMI-related
problems.
• Restrict use of cell phones, etc.
near the ultrasound unit.
The Accuro is intended for use in the electromagnetic environment specied below. The customer or the user of the
Accuro should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment — Guidance
RF Emissions CISPR
11
Group 1 The Accuro uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
However, a separation distance of 1.5 m shall be maintained.
RF Emissions CISPR
11
Class A The Accuro is suitable for any professional healthcare
environment.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
Flicker Emissions
Complies
Electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
20
Electromagnetic Compatibility (EMC)
The Accuro is intended for use in the electromagnetic environment specied 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 Compliance Level
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV ±4 kV ±8 kV ±15 kV air
In compliance
Electrical fast
transient/burst
IEC 6100-4-4
±2 kV
100 kHz repetition frequency
In compliance
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 eld
IEC 61000-4-8
30 A/m In compliance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
0,15 MHz – 80 MHz
6 V in ISM bands
between 0,15 MHz and 80 MHz 80 % AM at 1 kHz
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
3 V
3 V/m
Electromagnetic Immunity
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