dorsaVi ViMove2 User manual

USER MANUAL

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Table of contents
1. Regulatory Information
1.1 Symbols and labeling information ................................3
1.2 Indications for use ........................................................4
1.3 Warnings.......................................................................4
1.4 Contraindications..........................................................4
1.5 Precautions...................................................................4
1.6 Adverse reactions .........................................................4
1.7 Conformance to standards ...........................................5
1.8 How supplied................................................................5
1.9 Patient privacy & confidentiality................................... 5
2. System Description
2.1 Wireless sensors........................................................... 6
2.1.1 Charging light colour guide..................................6
2.1.2 Sensor light status colour guide..........................6
2.1.3 Charging your ViMove2 sensors ..........................6
2.1.4 Turning your ViMove2 sensors on ........................6
2.2 Sensor Adhesives .........................................................7
2.3 Sensor Overwraps ........................................................7
3. Setup and Installation
3.1 Before you start ............................................................7
3.2 ViMove2 app system requirements ..............................7
3.3 Software installation.....................................................7
4. Getting Started
4.1 Logging into your clinic ................................................8
4.2 Basic navigation ...........................................................8
4.2.1 Home screen........................................................8
4.2.2 Patient list screen................................................8
4.2.3 Patient assessment history screen......................8
4.2.4 Patient exercise program screen.........................9
4.2.5 Patient profile screen...........................................9
4.3 Syncing your device with dorsaVi.................................9
4.4 Viewing your account details........................................9
4.5 Creating a patient .........................................................9
4.6 Preparing for a patient assessment..............................9
5. ViMove2 Assessment Modules
6. ViMove2 Low Back
6.1 Low Back Live Assessment ........................................10
6.1.1 Starting a Low Back Live Assessment...............10
6.1.2 Standing lumbar tests screen............................11
6.1.3 Standing pelvic tilt test screen .......................... 12
6.1.4 Sitting tests screen............................................12
6.1.5 Sitting pelvic tilt test screen.............................. 13
6.1.6 Sitting rotation test ............................................13
6.1.7 Live Assessment test protocol...........................14
6.1.8 Viewing assessment data ..................................15
6.1.9 Compare assessment data ................................16
6.1.10 Share a report..................................................16
6.2 Low Back Monitoring..................................................17
6.2.1 Starting a Low Back Monitoring session ........... 17
6.2.2 Offloading Monitoring session data ...................18
6.2.3 Viewing Monitoring session data....................... 19
6.2.4 Monitoring session activity types ...................... 19
6.2.5 Share a report....................................................19
7. ViMove2 Run
7.1 Run Live Assessment..................................................20
7.1.1 Starting a Run Live Assessment ........................20
7.1.2 Live Assessment screen ...................................21
7.1.3 Capturing running data......................................21
7.1.4 Run metrics overview ........................................ 22
7.1.5 View Run Live Assessment data ........................22
7.1.6 Share a report....................................................23
8. ViMove2 Knee
8.1 Knee Live Assessment................................................24
8.1.1 Starting a Knee Live Assessment ......................24
8.1.2 Live Assessment screen ....................................25
8.1.3 Live Assessment test protocol...........................26
8.1.4 View Live Assessment data ...............................27
8.1.5 Share a report....................................................27
9. myViMove
9.1 Overview and features................................................28
9.2 myViMove app system requirements .........................28
9.3 Inviting your patients to myViMove.............................28
10. Device Specifications
11. Normative Data
12. Electromagnetic Emissions and Immunity
13. ViMove2 Store
14. Troubleshooting
15. dorsaVi Contact Details

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1. Regulatory Information
1.1 Symbols and labeling information
The following table lists the labels attached to various components of ViMove2.
Symbol Explanation
Follow instructions for use
Class II equipment
Type B Applied Part
FCC compliance
Polarity of the power supply
CE mark
Date of manufacture
Humidity limitation
Temperature limitation
Caution: US Federal Law
restricts this device to sale by
or on the order of a licensed
physician or healthcare
practitioner
Catalogue number
Serial number
Lot number
Symbol Explanation
AU / NZ safety certification
Authorised European
Representative
Use by date
Do not use if packaging is
damaged
Keep away from heat
Keep dry
Do not reuse

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1.2 Indications for use
ViMove2 is a wireless medical device system that measures,
records and analyses movement parameters of the lumbar
spine and other body regions. The system provides real-
time biofeedback in the form of visual signals encouraging
appropriate postures and movements, assisting in rehabilitation
and decreasing the recurrence of pain and dysfunction.
1.3 Warnings
None noted.
1.4 Contraindications
• Subjects with an implanted electronic device (for example a
cardiac pacemaker) should not be subjected to use unless
specialist medical opinion has first been obtained.
• Subjects with undiagnosed pain conditions.
• Subjects with diminished mental capacity or physical
competence limiting the use of the device.
• Pregnant Subjects, unless specialist medical opinion has
first been obtained.
• Subjects with a known skin condition or allergy, unless
specialist medical opinion has first been obtained.
1.5 Precautions
The following precautions should be observed when using the
ViMove2 device:
• When using any dorsaVi system, please plug the power
plug directly into a wall socket. Do not plug via a power
board / power strip unless the power board has been tested
and certified to all relevant electrical safety standards and
regulations.
• Please handle the power plug and charging cable with care.
Do not twist the charging cable. If twisting of the cable or
other deformities are observed, please contact dorsaVi
support.
• To preserve battery life, please ensure that the system is
fully charged at least once every 3 months. Failure to do
so may result in reduced battery performance (less than
12 hours).
• All skin mounted devices used to measure lumbopelvic
movement are subject to errors due to soft tissue artifact.
Determination of the pelvic orientation using ViMove2 has
not been validated for use on subjects with high Body Mass
Index (BMI) or adiposity.
• Only use the unit for purposes for which it is intended.
• Always ask the subject about skin allergies they may have
prior to ViMove2 use. Gauge the severity of the allergy
and assess whether a reduced session on ViMove2 and /
or using a protective film on the skin prior to application,
would be safer for the subject, or whether they should not
use ViMove2 at all if the allergy is of a serious nature.
• In order to reduce the risk of skin irritation, it is advised not
to wear the sensors for any more than 24 hours in any 72
hour period.
• There is the potential for patient injury or re-injury if there
is a function failure and the device fails to alert the patient
of risk related movements. To prevent this, the device has
been programmed to alert the patient / user if a signal loss
or other malfunction occurs. Ensure the patient is informed
of these features and is aware they may not receive reliable
movement data if one of these warnings is shown.
• Use only with the supplied power supply.
• As with all batteries there is a risk of battery leakage or
explosion. The manufacturer recommends operating
conditions between 0-45°C and storage 21-25°C.
• Do not clean the equipment with Acetone. Use alcohol
wipes for cleaning.
• Do not immerse any components of the device in water or
any other liquid substance.
• Use of any equipment should be immediately terminated
upon any sign of treatment-related distress or discomfort.
• Not to be connected to a subject undergoing MRI (Magnetic
Resonance Imaging), Electro surgery or defibrillation.
• Operations in close proximity to shortwave or microwave
therapy equipment may produce instability in the ViMove2
output.
• Do not operate the device within 10 feet (3 meters) of
powerful radio interference producing sources such as
arc welders, radio thermal treatment equipment, x-ray
machines, or any other equipment that produces electrical
sparks. Portable and mobile RF communication equipment
may also affect this equipment.
• Radiated radio frequency electromagnetic fields can cause
performance degradation in ViMove2.
• After use, the Sensor Adhesives may be a biohazard.
Following use, dispose of these materials in accordance
with accepted medical practice and any applicable local,
state and federal laws and regulations.
• The operator is responsible for ensuring the safety of any
devices controlled or triggered by ViMove2 equipment or
software, or by any software or hardware receiving data
from equipment. dorsaVi Ltd equipment must not be
configured or connected in such a way that failure in its
data acquisition, processing or control functions can trigger
subject feedback stimulus that poses an unacceptable
level of risk.
• Between uses of the device, wipe down components with
alcohol wipes or swabs.
• Ensure the subject does not perform any movement that
could cause an injury or that is beyond their capacity. The
clinician should use ViMove2 at their discretion and use
knowledge about the subject’s condition to inform their
decision making when conducting each assessment to
ensure safety.
1.6 Adverse reactions
The potential adverse reactions that may be experienced with
the use of the device include:
• Skin irritation beneath the Sensor Adhesives.

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1.7 Conformance to standards
Conformity Assessment Standard Applied:
ISO 13485
Medical devices – Quality management
systems – Requirements for regulatory
purposes
Medical Device Standards Applied:
ISO 14971 Medical Devices – Application of Risk
Management to Medical Devices
ISO 14155
Clinical investigation of medical devices
for human subjects - Good clinical
practice
IEC 60601-1
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
IEC 60601-1-2
Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
standard: Electromagnetic compatibility
- Requirements and tests
ISO 15223
Medical devices - Symbols to be used
with medical device labels, labeling,
and information to be supplied - Part 1:
General requirements
ISO 10993-5 Biological evaluation of medical devices
- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10
Biological evaluation of medical devices
- Part 10: Tests for irritation and skin
sensitization
16 CFR 1500
Guidelines of the Federal Hazardous
Substances Act (FHSA) Regulations for
Cytotoxicity, Sensitization and Primary
Skin Irritation tests.
1.8 How supplied
ViMove2 is supplied in a case containing the following
components:
• Two Mini Sensors.
• 100 Sensor Adhesives.
• 50 Sensor Overwraps.
• Charging cable.
• Power supply.
• Low Back template.
• Tibia template.
• Mini sensor wallet.
1.9 Patient privacy & confidentiality
dorsaVi complies with patient privacy legislation and
requirements in all countries in which it operates. A key part
of protecting patient privacy also relates to the IT setup of our
customers who use our software.
dorsaVi recommends smartphone and tablet devices that run
dorsaVi software be protected with a password. Furthermore,
a strong password should be chosen for the user’s ViMove2
account. The following are characteristics of a strong password:
• At least eight characters long.
• Does not contain your username, real name or company
name.
• Does not contain a complete word.
• Is significantly different from previous passwords.
• Contains uppercase and lowercase letters, numbers and
symbols.

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2. System Description
ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyse movement of the
lower back. The device objectively measures, records and analyses angular movement, vibration and acceleration. Under the direction
of the healthcare professional, the software guides the patient through a series of movements and postures in standing and sitting
positions. ViMove2 then measures the movement, streams the data live via Bluetooth Low Energy (BTLE) to a tablet or smartphone,
and generates a personalised assessment including comparisons to normative values.
2.1 Wireless sensors
2.1.1 Charging light colour guide
The charging light allows you to see the amount of sensor
charge remaining. This light only comes on when the sensor has
been turned on.
Light Colour Description
Solid green Sensor is fully charged and plugged in
Flashing green Sensor has between 50% and 99% charge
Flashing yellow Sensor has between 20% and 49% charge
Flashing red Sensor has between 6% and 19% charge
No light Sensor is off
2.1.2 Sensor status light colour guide
The sensor status light indicates the sensor activity status.
Light Colour Description
Flashing
red
Sensor is available for pairing or in an active
Monitoring session
Green Sensor is connected to ViMove2 as the green sensor
Blue Sensor is connected to ViMove2 as the blue sensor
2.1.3 Charging your ViMove2 sensors
Using the MicroUSB cable provided, plug the MicroUSB ends
into the sensors and the USB end into the power plug provided.
Alternatively, plug the USB end into a USB device such as your
computer.
For the fastest charging time it is recommended to charge your
device using the provided power plug. ViMove2 sensors take 1
hour to fully charge using a power plug.
2.1.4 Turning your ViMove2 sensors on
To turn your sensors on, press the ‘On’ button located at the
front of the sensor (see below).
ViMove2 sensors cannot be turned off manually. After 10
minutes of inactivity (excluding inactivity during an assessment)
the sensors will turn off automatically.
During a Live Assessment or Monitoring session the sensors will
not turn off unless they run out of charge.
1
2
4
3
1 Sensor status light.
2 Charging light.
3 Charging port.
4 On button.
5 Sensor serial number.
5

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3. Setup and Installation
3.1 Before you start
Before using ViMove2 make sure you have the following:
• ViMove2 Mini Sensor kit.
• ViMove2 App (see below for installation instructions).
• Appropriate fitment templates.
• Your username (email address) and password to log into ViMove2.
3.2 ViMove2 app system requirements
Devices*:
• Apple iPad Air 2 (or newer).
• Apple iPad Mini 4 (or newer).
iOS Version: 10.2.0 (or newer).
Free space: at least 500MB.
*If you are unsure about your device’s model number, please click here to visit Apple’s support center.
3.3 Software installation
ViMove2 can be download from the Apple App Store on your compatible tablet device. To download the software, open the App Store,
search for “ViMove2” and follow the prompts to download and install the software. Once the installation has finished, a “ViMove2” app
icon will appear on your home screen.
2.2 Sensor Adhesives 2.3 Sensor Overwraps
The Sensor Adhesives are used to attach
ViMove2 sensors to the patient’s skin.
To attach the Adhesives, peel them off
the Adhesive roll and stick onto the
sensor. Once stuck, remove the sticker
cover on the opposite side (see diagram
to the left) and apply to the patient.
The Sensor Overwraps are used to hold
the ViMove2 sensors in place for longer
periods of time during a Low Back
Monitoring session.
To apply the overwraps, peel off the
stickers on the back of the Overwraps
and stick over the ViMove2 sensors in
landscape orientation.

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4. Getting Started
4.1 Logging into your clinic
To login to ViMove2 for the first time, you will receive an email from dorsaVi containing a temporary password to gain access to your
clinic. Follow the prompts in this email to login to your clinic and set a new password for your account. For subsequent logins, open the
ViMove2 app, enter your login details (email address and password) and press “Login”. After logging in, your device will now connect
to the dorsaVi server to download your clinic’s data. The sync process may take some time depending on the speed of your internet
connection and the amount of clinic data.
4.2 Basic Navigation
4.2.1 Home screen
4.2.2 Patient list screen
4.2.3 Patient assessment history screen
1
2
3
1 View the sensor ID and battery life of nearby sensors.
2 View your patient list, assessment data, begin new assessments and
create new patients.
3 View and edit your user account information.
4 Logout of ViMove2, contact dorsaVi or visit the ViMove2 support center.
5 View a quick demo video about ViMove2.
The patient list screen allows the user to see each patient in their
clinic, add patients and view assessment data
1 The side panel provides a quick way to navigate to the home screen, view
your patient list and check your sync status.
2 Sort the patient list alphabetically or by the date of their last assessment.
3 Add a new patient to your clinic.
4 This section displays the name of each patient in your clinic, the time
of their last assessment, the treating clinician’s name and whether the
patient is in an active Monitoring session. To view a patient’s profile,
select their name.
5 View and edit your user account information.
12
4
3
5
1
24
3
5
The patient assessment history screen contains all assessment
information and data recorded by ViMove2 for a selected patient.
1 The side panel allows you to quickly navigate to previous assessments
performed by the patient by selecting one of the assessments.
2 Patient details and history.
3 View assessments history, prescribed exercise programs and edit the
patient’s profile.
4 Start a new assessment test.
5 Quick navigation links to the home screen, patient list screen, user
account screen and sync status.
4
5

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4.2.4 Patient exercise program screen 4.2.5 Patient profile screen
4.3 Syncing your device with dorsaVi’s central servers
All patient information and assessment data recorded byViMove2 is securely stored in dorsaVi’s central servers. To store this information
or share it with other users in the clinic, data must be “synced” between the ViMove2 app and the servers. To check if your device is
synced refer to the “sync status” icon (see 4.2.3). If a “Data not synced” message is displayed, simply press the icon to sync your
device. The sync process may take some time depending on the speed of your internet connection and the amount of clinic data.
4.4 Viewing your account details
To view your user account information, select “My Account” from the ViMove2 Home Screen. Alternatively, select your username at the
bottom left hand corner of the screen at any time while using ViMove2.
4.5 Creating a patient
To create a patient, navigate to the patient list screen and select the “Add Patient” button located at the top right of the screen. Follow
the on-screen prompts to enter all relevant patient information. Once all information has been entered, click the “Add Patient” button
to create your new patient.
4.6 Preparing for a patient assessment
Prior to starting an assessment please ensure your device meets the following requirements:
• iOS device is reasonably charged (above 50%).
• ViMove2 sensors are reasonably charged (above 50%).
• Bluetooth on your iOS device is turned on.
5. ViMove2 Assessment Modules
Module Assessments Usability myViMove patient app usability
Low Back Live Assessment
Monitoring
The Low Back module contains a series of tests designed to
provide an objective measure of Range of Motion (ROM) for the
lumbar spine for up to 24 hours in the patient’s daily activities.
• View past assessment reports.
• Track monitoring progress.
• Record pain alerts.
• Watch suggested exercises.
Run Live Assessment
The Run module allows clinicians to observe the effects of
speed, footwear and distance on a patient’s ability to maintain
an effective running style.
• View past assessment reports.
• Watch suggested exercises.
Knee Live Assessment
The Knee module accurately measures range, speed and
direction of knee movement in two planes while performing
high-speed tests.
• View past assessment reports.
• Watch suggested exercises.
Following a Low Back, Run or Knee assessment, this screen
will begin to populate with the exercises you selected and the
exercises suggested by ViMove2.
On this screen you will be able to view, edit and update patient
information. You can also invite the patient to myViMove by
selecting the “Invite Patient” button.

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6. Low Back
6.1 Low Back Live Assessment
The Low Back Live Assessment allows clinicians to measure the degree of movement in a patient as they perform a range of selected
tests. Following a Low Back Live Assessment, an easy-to-read report is generated which displays all movement data obtained
throughout the assessment.
6.1.1 Starting a Low Back Live Assessment
1. From the patient list screen, select
the patient you would like to test and
select “New Test”. Following the on-
screen prompts, select “Low Back”
then “Live Assessment”.
2. Push the button on the side of the
ViMove2 sensors to turn them on.
From the sensor selection screen, tap
on the sensors with the corresponding
serial numbers.
3. Peel the Sensor Adhesives off the
adhesive roll and apply to the back of
the ViMove2 sensors.
4. Locate the PSIS by palpating the
superior aspect of the iliac spine.
When located, mark the PSIS by
drawing small circles over them.
5. Use a ruler to draw a horizontal line
through the centres of the PSIS circles
and place the pelvic (lower) sensor
on the body in landscape orientation
directly underneath the line.
6. Using the Low Back fitment template,
place the upper sensor on the patient
so it sits at T12/L1 level. Ensure
the sensor is placed in landscape
orientation.
7. Once the sensors are attached, ask
the patient to bend forward. Next,
press down firmly on the sensors
8. Select “I attached both sensors” in
the ViMove2 app.
9. Following the on-screen prompts,
ensure the top sensor is flashing
green and the bottom sensor is
flashing blue on the patient. If this is
correct, select “Yes” in the ViMove2
app. If the colours are incorrect select
“No, swap colors”.
10. On the calibration screen follow the
on-screen prompts to ensure correct
calibration of the ViMove2 sensors.