FCC ID: PTK-MDMV6B ViMove Wireless Medical Device

ViMove v6 User Manual ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 Contents 1. Regulatory Information ....................................................................................................................... 1 1.1 Symbols and Labelling Information .............................................................................................. 1 1.2 Indications for Use ........................................................................................................................ 2 1.3 Warnings ....................................................................................................................................... 2 1.4 Contraindications .......................................................................................................................... 2 1.5 Precautions ................................................................................................................................... 2 1.6 Adverse Reactions ......................................................................................................................... 3 1.7 Conformance to Standards ........................................................................................................... 4 1.8 FCC Compliance Statements ......................................................................................................... 4 1.9 How Supplied ................................................................................................................................ 5 1.10 Patient Privacy & Confidentiality ................................................................................................ 5 2. System Description ............................................................................................................................. 6 2.1 Movement Sensors ....................................................................................................................... 6 2.2 Muscle Activity Sensors ................................................................................................................ 6 2.3 Sensor Adhesives .......................................................................................................................... 6 3. Setup and installation ......................................................................................................................... 6 3.1 Before you Start ............................................................................................................................ 6 3.2 ViMove App System Requirements and Compatability ................................................................ 6 3.3 Software Installation Steps ........................................................................................................... 7 3.4 Activating Your Software .............................................................................................................. 7 4. Getting Started .................................................................................................................................... 7 4.1 User Login ..................................................................................................................................... 7 4.1 Basic Navigation ............................................................................................................................ 7 4.1.1 Home Screen .......................................................................................................................... 7 4.1.2 Patient List Screen .................................................................................................................. 8 4.1.3 Patient Overview Screen ........................................................................................................ 8 4.1.4 Sensors Screen ....................................................................................................................... 8 4.1.5 Feedback Screen .................................................................................................................... 9 4.2 Creating a patient ......................................................................................................................... 9 4.3 Sessions ......................................................................................................................................... 9 4.3.1 Sessions Overview .................................................................................................................. 9 4.3.2 Create a New Session ............................................................................................................. 9 5. Available Modules ............................................................................................................................... 9 6. Low Back ........................................................................................................................................... 10 6.1 Overview ..................................................................................................................................... 10 6.2 Sensor Fitment ............................................................................................................................ 10 ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 6.3 Live Assessment .......................................................................................................................... 12 6.3.1 Beginning a Live Assessment ............................................................................................... 12 6.3.2 Low Back Live Assessment Test Protocol ............................................................................. 14 6.3.3 View Session Data: Live Assessment Overview Screen ........................................................ 15 6.3.4 View Session Data: Live Assessment Detailed View Screen ................................................ 15 6.4 Monitoring .................................................................................................................................. 16 6.4.1 Beginning a Monitoring Assessment.................................................................................... 16 6.4.2 Ending a Monitoring Assessment......................................................................................... 17 6.4.3 View Session Data: Monitoring Assessment Overview........................................................ 17 6.4.4 View Session Data: Monitoring Detailed View .................................................................... 18 6.4.5 Monitoring Session Activity Types ....................................................................................... 18 7. Clinical Examples ............................................................................................................................... 19 8. Reporting ........................................................................................................................................... 19 8.1 Create a Report ........................................................................................................................... 19 8.2 Exporting a Report ...................................................................................................................... 19 9. Device Specifications ......................................................................................................................... 20 9.1 Lumbar Spine Data Accuracy ...................................................................................................... 20 10. Normative Data ............................................................................................................................... 21 11. Electromagnetic Emissions and Immunity ...................................................................................... 21 12. Troubleshooting .............................................................................................................................. 24 13. dorsaVi Contact Details ................................................................................................................... 24 ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 1. Regulatory Information 1.1 Symbols and Labelling Information The following table lists the labels attached to various components of ViMove. Symbol Explanation Consult 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 AU / NZ safety certification Authorized European Representative Use by date Do not use if packaging is damaged ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 1 Keep away from heat Keep dry Do not reuse 1.2 Indications for Use ViMove is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes. Caution: US Federal Law restricts this device to sale by or on the order of a licensed physician or healthcare practitioner. 1.3 Warnings None noted. 1.4 Contraindications Patients with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to use unless specialist medical opinion has first been obtained. Patients with undiagnosed pain conditions. Patients with diminished mental capacity or physical competence limiting the use of the Pregnant patients, unless specialist medical opinion has first been obtained. Patients with a known skin condition or allergy, unless specialist medical opinion has first device. been obtained. 1.5 Precautions The following precautions should be observed when using the ViMove device:

When using any dorsaVi system, please plug the power supply 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 supply and cable with care. Do not twist the power supply 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 ViMove has not been validated for use on patients with high Body Mass Index (BMI) or adiposity. Only use the unit for purposes which it is intended. Always ask the patient about skin allergies they may have prior to ViMove use. Gauge the severity of the allergy and assess whether a reduced session on ViMove, and / or using a protective film on the skin prior to application, would be safer for the patient, or whether they should not use ViMove at all if the allergy is of a serious nature. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 2 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 if a signal loss or other malfunction occurs. Ensure the patient is informed of these features and are aware they will not be receiving Biofeedback if one of these warnings is shown. Use only with supplied power supply. Recording and Feedback Device (RFD) Battery: As with all batteries, there is a risk of battery leakage or explosion; however, the manufacturer of the RFD battery has conducted safety tests, heating the batteries to 130C for ten minutes with no rupture, no fire, bursting or explosion. In addition, the battery is housed in the sealed, splash resistant RFD unit. 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-

Not to be connected to a patient undergoing MRI (Magnetic Resonance Imaging), Electro Operations in close proximity to shortwave or microwave therapy equipment may produce related distress or discomfort. surgery or defibrillation. instability in the output. Do not operate the device within 10 feet 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 ViMove. After use, the Disposable Application Pads (DAPs) 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 ViMove equipment or software, or by any software or hardware receiving data from equipment. dorsaVi USA, Inc. equipment must not be configured or connected in such a way that failure in its data acquisition, processing or control functions can trigger patient feedback stimulus that poses an unacceptable level of risk. Between uses of the device, wipe down components with alcohol wipes or swabs. 1.6 Adverse Reactions The potential adverse reactions that may be experienced with the use of the device include:

Skin irritation beneath the adhesive pads and / or electrodes (DAPs). ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 3 1.7 Conformance to Standards Conformity Assessment Standard Applied:

ISO 13485 Medical Device Standards Applied:

ISO 14971 ISO 14155 Medical devices Quality management systems Requirements for regulatory purposes. IEC 60601-1 IEC 60601-1-2 IEC 62304 IEC 62366 ISO 15223 ISO 10993-5 ISO 10993-10 16 CFR 1500 Medical Devices Application of Risk Management to Medical Devices. Clinical investigation of medical devices for human subjects - Good clinical practice. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility

- Requirements and tests. Medical device - Software life cycle processes Medical devices - Application of usability engineering to medical devices. Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Guidelines of the Federal Hazardous Substances Act (FHSA) Regulations for Cytotoxicity, Sensitization and Primary Skin Irritation tests. 1.8 FCC Compliance Statements Information to the user (FCC Part 15.105) CLASS B DEVICE This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encourage to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna Connect the equipment into an outlet on a circuit different from that to which the receiver is Increase the separation between the equipment and receiver connected Consult the dealer or an experienced radio/TV technician for help Cet appareil est conforme la partie 15 des rgles de la FCC et de l'innovation, des sciences et de dveloppement conomique RSS normes exemptes de licence de (ISED) Canada. Le fonctionnement est soumis aux deux conditions suivantes:

1. cet appareil ne peut pas provoquer dinterfrences et 2. cet appareil doit accepter Toute interfrence, y compris les interfrences qui peuvent causer un mauvais fonctionnement du dispositive ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 4 Modification Warning (FCC Part 15.21) Any changes or modifications not expressively approved by dorsaVi could void the user's authority to operate this equipment FCC and RSS-Gen Section 8.4 and RSP-100 Section 4 This device complies with Part 15 of the FCC Rules and Industry Canadas license-exempt RSSs. Operation is subject to the following two conditions:

1. This device may not cause interference; and 2. This device must accept any interference, including interference that may cause undesired operation of the device. 1.9 How Supplied ViMove is typically supplied containing the following components:

Two wireless movement sensors. Two muscle activity sensors. Disposable Application Pads to attach the sensors to the patient. ViMove software package. Sensor placement template, double USB cable and power plug. 1.10 Patient Privacy & Confidentiality dorsaVi complies to 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 that all customer computers and devices that run dorsaVi software be protected with a sufficient username and password policy. 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. Contains uppercase and lowercase letters, numbers and symbols. Is significantly different from previous passwords. For more information on password policies, please contact your dorsaVi representative. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 5 2. System Description ViMove is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device objectively measures, records and analyzes angular movement, muscle activity, 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. ViMove then measures the movement and muscle activity, streams the data live via BTLE to an iOS tablet device and generates a personalized assessment including comparisons to normative values. ViMove v6 is comprised of the following key components:

4 Wireless Sensors (2 movement and 2 muscle activity). Disposable Application Pads to attach sensors to the patient. ViMove software package. 2.1 Movement Sensors 2.2 Muscle Activity Sensors 2.3 Sensor Adhesives The Movement and Muscle Activity Sensor Adhesives are used to attach the sensors to the subjects skin. There are two types of Movement Sensor Adhesives:

1. 30-minute Sensor Adhesives for Live Assessments. 2. Monitoring Sensor Overwraps for use up to 24 hours during Monitoring Assessments. 3. Setup and installation 3.1 Before you Start Make sure you have the following items provided by dorsaVi:

Hardware kit;

ViMove application;

Appropriate fitment templates;

Your username and password. 3.2 ViMove App System Requirements and Compatibility ViMove is compatible only with the following tablet devices:

Apple iPad 4th generation (or newer). Apple iPad Mini 2 (or newer). ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 6 3.3 Software Installation Steps ViMove software can be download from the Apple App Store on your compatible Apple tablet device. To download the software, open the Apple App Store, search for ViMove and follow the prompts to download and install the software. Once the installation has finished, a ViMove shortcut icon will appear on your home screen. 3.4 Activating Your Software When the application is opened for the first time it will need to be activated with dorsaVis central servers. To do so, please enter your username and password provided to you by dorsaVi. Once your username and password are entered, press the next button. Your device will now connect to the dorsaVi server to download the software for the hardware devices and test procedures. This process will take some time depending on the speed of your internet connection. 4. Getting Started 4.1 User Login When you first open ViMove, you will be presented with a Login Screen. On this screen, you will need to enter your unique Username and Password provided to you by dorsaVi. If you cannot remember your username or password, please contact your dorsaVi representative. 4.1 Basic Navigation 4.1.1 Home Screen Opens the Patient List Screen (see 4.1.2) Opens the Sensor Management Screen

(see 4.1.4) Opens the Feedback Screen (see 4.1.5) ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 7 4.1.2 Patient List Screen Add a new patient Navigate to a patient based on their first name 4.1.3 Patient Overview Screen Back to Home Screen Back to Patient List Screen Sort and filter patients according to assessment dates and types Patient List. Click on a patients name to open the Patient Overview Screen (see 4.1.3). Open settings screen Create a report (see 8.) Begin a new session Session list for the patient which displays the session number, session date and the total session time. See 4.3 for more information on sessions. Displays a quick overview of the last session recorded by the patient 4.1.4 Sensors Screen The Sensor Management screen allows the user to view the status of all sensors within their clinic with regards to:

Sensor ID numbers currently owned by the clinic.

-

- Battery life of each sensor.

- Availability of each sensor. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 8 4.1.5 Feedback Screen The feedback screen allows users to submit questions or comments about ViMove hardware and software to dorsaVi. 4.2 Creating a patient Navigate to the Patient List Screen and select the Add Patient Icon located at the top left 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. 4.3 Sessions 4.3.1 Sessions Overview In ViMove, sessions are a group of live assessments and monitoring assessments performed during a ViMove session with the clinician. Each session can have one live assessment and one monitoring assessment associated with it. For each new live assessment or monitoring assessment, a new session will need to be created. A patient can have multiple sessions recorded against their name. 4.3.2 Create a New Session To create a new session, navigate to a patients overview screen and select Begin New Session. After pressing this button, you will then be able to set-up a Live Assessment or Monitoring Assessment against the new session created (See 6.3.1 and 6.4.1 for further steps on setting up live assessments and monitoring assessments). 5. Available Modules Modules Low Back Assessment Types Live Assessment Monitoring Usability The Low Back module contains a series of tests designed to provide an objective measure of Range of Motion (ROM) and muscle activity for the lumbar spine for up to 24 hours in the patients day to day activities. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 9 6. Low Back 6.1 Overview The Low Back module contains a series of tests designed to provide an objective measure of Range of Motion (ROM) and muscle activity for the lumbar spine. 6.2 Sensor Fitment Locate the PSIS by palpating the superior aspect of the iliac spine. When located, mark the PSIS on both the patients left and right by drawing small circles or crosses over them. 1 3 1 2 4 2 Use a ruler to draw a horizontal line through the centers of the PSIS circles / crosses. Use the electric trimmer to clip the patients back hair where the sensors will be placed (if required). For patients with sensitive skin, use skin protective spray or wipe on the MDM sensor placement area. Do not use protective spray under MDE sensors (EMG) because it reduces the electrical signal. Wipes can be used with MDE sensors. Apply sensor adhesives to the back of the ViMove sensors. Once attached, place the pelvic (lower) sensor on the body in landscape orientation directly underneath the line, ensuring the sensor light is located in the top right hand corner. Do not push down firmly on the sensors at this stage. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 10 Using the appropriately sized template, place the upper sensor on the patient so it sits at T12/L1 level. Ensure the sensor is placed in landscape orientation. Using the appropriately sized template, place the two EMG sensors on the patient. Ensure the sensors are placed in portrait orientation with the sensor light located at the top. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 11 6.3 Live Assessment 6.3.1 Beginning a Live Assessment From the Patient List Screen, select the patient you would like to test. This will open the Patient Overview Screen. On this screen, select Begin New Session. Follow the on-screen prompts to pair the sensors with the software. Begin by turning on the sensors and selecting them within the software. Now, commence pairing of the sensors to the software. Once complete, select Next. Using the on-screen prompts as a guide, or by following the steps in 5.1.2, attach the sensors to the patient. Once the sensors are applied select Calibrate and begin session. On the calibration screen, follow the on-screen prompts to ensure correct calibration of the sensors and the ViMove software. Once calibration is complete, choose the Live Assessment option from the software to proceed with a Live Assessment. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 12 On the next screen, select Auto Detection if you would like the software to automatically detect flexion, extension, left lateral flexion and right lateral flexion movements performed by the patient. NOTE: Other tests in the Low Back Application will still need to be started and stopped manually. Deselecting this option allows the clinician to manually start and stop each of the tests mentioned above. Once an option has been selected, press Begin Session. Record flexion, extension, left lateral and right lateral movements as per the test protocol below in 5.3.2. The other Low Back tests can be added once these first 4 tests have been completed. Once the first 4 tests have been completed, the following Session Overview screen will be displayed. To add more tests to the current Live Assessment, select the Add Test button. To recalibrate Lordosis, select Recalibrate. For a detailed overview of this screen, see 6.3.3 ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 13 6.3.2 Low Back Live Assessment Test Protocol For each of the tests in the software, the movements below can be tested: this is a typical movement protocol. Any pain experienced during the session can be recorded on a 1-10 scale by selecting a number on the top right hand corner of the screen (1 being not painful at all, and 10 being extremely painful). Flexion 1. Ask the patient to stand upright and flex forward as far as comfortable without bending the knees, hold for 2 seconds and then return to standing position. 2. Once the patient has returned to standing position, ask the patient to repeat the movement until 3 repetitions are complete. 3. Note: the flexion movement usually takes 3-4 seconds to perform. Extension position. 1. Ask the patient to fold the arms across the chest and stand upright. 2. Ask the patient to bend back (extension) as far as comfortable, and then return to standing 3. Ask the patient to repeat the movement until 3 repetitions are complete. 4. NOTE: The extension movement usually takes 3-4 seconds to perform. Lateral Flexion (Left and Right) 1. Ask the patient to stand upright with arms along the sides of their body. 2. Ask the patient to bend sideways (flex laterally) and slide their arm along the leg as far as comfortable while avoiding any flexion / extension, hold for 2 seconds and then return to standing position. 3. Ask the patient to repeat the movement until 3 repetitions are complete. NOTE: the lateral flexion movement usually takes 3-4 seconds to perform. Anterior Posterior Tilt while Standing 1. Ask the patient to stand upright with their hands on their hips. 2. Ask them to tilt their pelvis forward (anteriorly) and then backward (posteriorly) in a controlled manner. It may help to say Make an arch in your back and then flatten your back. 3. Ensure the patient does not move their trunk. 4. Allow a few practice tilts in both directions prior to testing. 5. During testing ensure 3 repetitions are performed in the same test window. Usual Sitting Position Slouched Sitting Position Upright Sitting Posture 1. Ask the patient to sit in a chair (ideally a desk chair) in their usual sitting posture. 2. Once the patient is seated, ask them to hold the position and begin the test. 1. Ask the patient to sit in a chair and slouch as they usually would. 2. Once the patient is sitting in a slouched posture, begin the test. 1. Ask the patient to sit in a chair in an upright posture. 2. When the patient is sitting in an upright posture, begin the test. Anterior Posterior Tilt while Sitting 1. Ask the patient to sit in a chair with back unsupported and in an upright posture. 2. Ask the patient to place their hands on their hips and tilt forward (anterior) and back (posterior). The patient must attempt to initiate and control the movement from their pelvis while avoiding any trunk movement. 3. During testing ensure 5 repetitions are performed in the same test window. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 14 6.3.3 View Session Data: Live Assessment Overview Screen Open settings screen Create a report (see 8.) Toggle Reference Groups ON/OFF Set Pain Scores for the selected movement Zoom IN/OUT of the session movements Filter the session movements by type This section displays the tests in current sessions Live Assessment. In this section, you can recalibrate your patients lordosis, record movements and add tests. Single-clicking a test will open the Detailed View Screen for the selected movement (see 6.3.4) Compare the current assessments to previous assessments & examples (see 7.) The session movement section displays each test recorded during the assessment along with the pain score recorded. Slide the tests across to have them appear on the Single-clicking a test will open the Live Assessment Detailed View Screen (see 6.3.4) screen above. 6.3.4 View Session Data: Live Assessment Detailed View Screen Displays a detailed view of the test selected from the panel below. In this section you can compare the patients movements to standard deviations from reference data, view a summary for the movements and track progress. Zoom IN/OUT of the session movements The session movement section displays each test recorded during the assessment along with the pain score recorded. Slide the tests across to have them appear on the screen above. Single-clicking a test will display the movement in the box above this panel. Create a report (see 8.) Open settings screen Displays the selected movement as it moved in real-time along with the pain score recorded Filter the session movements by type Recapture the selected movement ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 15 6.4 Monitoring 6.4.1 Beginning a Monitoring Assessment From Patient List Screen, select the patient you would like to test to open the Patient Overview Screen. On this screen, select Begin New Session to start a new session. Alternatively, select a session which already exists and select Monitoring to add an assessment to the session. Follow the on-screen prompts to pair the sensors with the software. Begin by turning on the sensors and selecting them within the software. Now, commence pairing of the sensors to the software. Once complete, select Next. Using the on-screen prompts as a guide, or by following the steps in 5.1.2, attach the sensors to the patient. Once the sensors are applied, select Calibrate and begin session. On the calibration screen, follow the on-screen prompts to ensure correct calibration of the sensors and the ViMove software. Once calibration is complete, choose the Monitoring assessment option from the software to proceed. The sensors will now begin recording the patients movement and muscle activity. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 16 6.4.2 Ending a Monitoring Assessment To end a Monitoring Assessment, remove the sensors from the patient. Next, go to the Patients Overview Page and select the Offload icon to offload the data. Once the data offload is complete, a notification will appear in the software. And you will be presented with the screen below. 6.4.3 View Session Data: Monitoring Assessment Overview Total Monitoring Assessment length This section displays the activities in the Monitoring Assessment. Single-clicking a test will open the Detailed View Screen for the selected activity

(see 6.3.4) Zoom IN/OUT of the Assessment tests Compare the current assessments to previous assessments & examples (see 7.) Displays the 4 activities recorded during a Monitoring Assessment, along with the amount of time recorded for each activity and how they compared to the patients goals. Single-

clicking an activity will open the Monitoring Assessment Detailed View Screen (see 6.3.4) Filter the session movements by type The session movement section displays each test recorded during the assessment. Slide the Single-clicking a test will open the Monitoring Assessment Detailed View Screen (see 6.3.4) tests across to view the data. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 17 6.4.4 View Session Data: Monitoring Detailed View This section displays the total amount of activity time in a session and how it compares to goals set by the clinician. Detailed Analysis Panel This section displays a detailed analysis of the activity selected in the Time Breakdown panel, allowing clinicians to view a breakdown of the activity and its sub-activities (For more information on sub-activities, see 6.4.5). Clicking the previous or next buttons will display the previous or next breakdown of the same task. Displays the patient movement at the time select by the black vertical line in the Time Breakdown Panel. Zoom IN/OUT of the Assessment tests Filter the session movements by type This panel displays a minute-by-minute breakdown of the entire Monitoring Assessment recorded. Movements are broken down into sections of similar activity and displayed linearly according to the time they were recorded. Sliding this panel left or right adjusts the values in the Detailed Analysis panel to display the results of the section that intersects with this panels black vertical line. Time Breakdown Panel 6.4.5 Monitoring Session Activity Types The Monitoring Assessment records four different types of activities, as seen in 6.4.3. Each of these activities has three sub-activities which can be found in the Monitoring Detailed View (see 6.4.4). The following are the four activities and sub-activities found in the Monitoring Assessment. Activity Standing Sitting Active Lying Down Sub-activity Neutral Flexion Extension Upright Natural Slouched Walking Running Dynamic Back Front Side ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 18 7. Clinical Examples You can compare your patients session data to previous sessions performed by the patient and reference data sets. Available in Live Assessment and Monitoring, you can access this panel by click the Compare button. See 6.3.3 to locate the button on the Live Assessment Overview Screen and 6.4.3 to locate the button on the Monitoring Assessment Overview Screen. When a data set has been dragged and dropped into the Add comparison box, the comparison data will appear on the applicable tests and activities in the Overview screen. 8. Reporting 8.1 Create a Report On the Assessment Overview and Detailed views for Live Assessment and Monitoring, selecting the report button allows you to generate a report of the data you are viewing. When generating the report, follow the on-screen prompts to ensure the correct report is generated. 8.2 Exporting a Report Once a report has been generated it can be saved, printed or emailed by selecting the appropriate option in the report view. ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 19 9. Device Specifications Below are the specifications for dorsaVis system hardware. If you have any questions, please contact your dorsaVi representative. COMPONENT NAME CATALOGUE NUMBER MDMv6b v6b4T Battery Use Type Rechargeable Battery Voltage 3.7 Volt Battery Type Lithium-Polymer Battery Capacity 165mAh Battery Life (Max) 300Cycles UE10WCP2-050100SPC-M2 AC Adapter Model AC Adapter Input Voltage 110 / 240V AC AC Adapter Output Charging Data Connector Min Range Max Range 2G 250dps 16G 2,000dps 4900T Axis 3 3 3 Bit Depth 16bit 16bit 16bit 5.5 V DC, 2A AC Power Adapter or USB Port (TypeA) USB Micro-B Type Accelerometer Gyroscope Magnetometer NAND Flash 256MB Yes No 1 2 x RGB 2.4GHz ISM Max 20m/60ft ABS Yes 30mm / 1.18in. 42mm / 1.65in. 8mm / 0.32in. 12g / 0.42oz. Sensor Types Memory Type Memory Size Reset Button Display Input Buttons Visible LEDs Frequency Band Wireless Range External Material RoHS Sensor Width Sensor Length Sensor Height Sensor Weight 9.1 Lumbar Spine Data Accuracy Movement Planes Sagittal Plane Error Coronal Plane Error 1D Movements

<3 RMSE

<3 RMSE 2D Movements

<3 RMSE

<3 RMSE ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 20 10. Normative Data Normative values provided in the ViMove assessment reports are based on an analysis of lumbo-

pelvic range of motion in 50 adults with no history of chronic lower back pain (LBP). Participants in the study were guided through a set of simple standardized postures and movements, in standing and sitting positions, while wearing ViMove sensors. Range of motion data collected included standing lordosis, flexion, extension, lateral flexion, and pelvic tilt

(anterior and posterior) in sitting and standing. The age range for the normative data collection was 19-62 (mean 35 12). Normative data has not been collected outside this age range. Data was stratified according to gender and age groups

(18-29, 30-39, 40-49, 50-65). The following table summarizes the ViMove normative values established for males and females combined. Normative data was calculated for each age group, with the values summarized below presented as the minimum and maximum mean over all age groups. NOTE: The normative values displayed in the ViMove Live Assessment reports are based on the mean and 95% confidence intervals calculated for each age group, using combined male and female values. 11. Electromagnetic Emissions and Immunity ViMove complies with the requirements of IEC 60601-1-2. The recommended tables for electromagnetic emissions per sub-clause 5.2.2.1(c) and electromagnetic immunity per sub-clause 5.2.2.1(f) & 5.2.2.2 are provided on the following pages:

ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 21 ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 22 ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 23 12. Troubleshooting Unsure about a part of our software or need extra help to use ViMove? Visit http://support.dorsaVi.com to watch video tutorials and read Q&As related to every part of our software and hardware. 13. dorsaVi Contact Details dorsaVi USA, Inc. C/o Lurie llp, KHB 2501 Wayzata Blvd, Minneapolis, MN 55405 US Email:

US Support:

Web:

info@dorsavi.com support.us@dorsavi.com us.dorsavi.com ViMove v6 User Manual | dorsaVi USA, Inc. | Rev. 20170203 24