PRECISION BIOMETRICS, INC

MyoVision 3G Wirefree User Manual

Specification and procedures outlined in this manual are subject to change without notification. 2010, Precision Biometrics, Inc. (USA) 4259 23rd Ave W. #400 Seattle, WA 98199 www.MyoVision.com Phone 206-448-3464 Fax 206-770-6176

FEDERAL (USA) LAW RESTRICTS USE OF THIS PRODUCT BY OR ON THE ORDER OF A PHYSICIAN.
. All rights reserved Copyright 2010 by Precision Biometrics, Inc. This manual may not be reproduced by any means of information storage, retrieval or reproduction without written permission from Precision Biometrics, Inc.

23-000-LBL01 Rev E

Page 1 of 60

Table of Contents

Introduction ........................................................................................................................... 3 Explanation of all labeling.................................................................................................. 11 Software and hardware installation................................................................................... 17 3G Scanvision Static sEmg & Thermovision procedures ............................................... 30 Software features ................................................................................................................ 36 MyoVision use, maintenance and troubleshooting ......................................................... 50 MyoVision return policy ..................................................................................................... 60

23-000-LBL01 Rev E

Page 2 of 60

MyoVision 3G Wirefree System

Introduction
The MyoVision 3G WireFree System is made up of handheld devices that gather data and software on a computer that displays the data. The devices use the physiological and anatomical measurement technologies of Surface Electromyography, Range of Motion and Thermography. Surface Electromyography is used in two subsystems; Static sEMG and Dynamic sEMG. Surface Electromyography (sEMG): This is the measurement of muscle activity. It functions in the same manner as an EKG, measuring a summation of all the electrical depolarizations in the region where the electrodes are either attached to the skin, Dynamic sEMG, or momentarily touched to the skin, Static sEMG. The DynaVision device is used in Dynamic sEMG. During Dynamic sEMG, muscle activity readings are measured as the patient moves. The ScanVision devices are used in Static sEMG. With Static sEMG, a set of probes are touched to the skin momentarily on left and right sides of the spine simultaneously, above the paraspinal muscles. Range of Motion: This component uses two sensors to measure angle of bending of the bodys various joints. The FlexVision devices are used in Range of Motion. By using two devices which measure angle simultaneously, the motion of the region of interest is measured more accurately since the difference between the two angle-measuring devices automatically subtracts out the motion of both, to only show the actual movement of the region measured. Thermography: The ThermoVision device is used in Thermography. The device measures skin temperature via small infrared temperature sensors on left and right sides of the spine simultaneously. The device is rolled up the spine gathering skin temperature data looking for symmetries in skin temperature when comparing left and right sides of the spine.

23-000-LBL01 Rev E

Page 3 of 60

3G WireFree System: Scanners and Accessories

SYSTEM DEVICES

3G Wirefree ScanVision Adaptive Static Scanning sEMG

3G Wirefree DynaVision Dynamic sEMG

3G Wirefree FlexVision Range of Motion

PhysioMonitor: Multiple device capable system hub

SoloVision: Single device capable system hub

MyoVision Vision Cart

Software Professional All-In-One Display ThermoVisonThermograph

USB Cable for 3G WireFree Hub

AC Adaptor for 3G WireFree PhysioMonitor

Charging Cable for FlexVision

Charging Cable for ThermoVision

POWER CABLES

Power Cable for US

Power Cable for EU

Power Cord for UK/IRE

23-000-LBL01 Rev E

Page 4 of 60

DISPOSABLES

Static Electrodes

QuickScan Pads

Disposable Dynamic EMG Electrodes

23-000-LBL01 Rev E

Page 5 of 60

INDICATIONS FOR USE: The device is indicated to provide visual physiological signals corresponding to muscle activity (Static Surface EMG and Dynamic Surface EMG), Range of Motion, and Thermography. This device is intended to be used by or prescribed by a physician or licensed practitioner for muscle relaxation training and muscle reeducation including conditions such as soft tissue injury and muscle imbalance about the spine and other regions. DESCRIPTION OF THE DEVICE: The 3G Wirefree system provides healthcare professionals with physiological information on the musculoskeletal condition of their patients. By measuring muscle activity (Surface EMG) Range of Motion (ability to bend in different directions) and Thermography (skin temperature readings), the healthcare professional is able to assess the condition of the patient. This device is intended to be used for muscle relaxation training and muscle reeducation including conditions such as soft tissue injury and muscle imbalance about the spine and other regions. These biofeedback applications are used for tracking and documenting patient progress throughout treatment. The physiological and anatomical data are received by the users computer and displayed on a monitor as graphs and charts for concurrent viewing by the healthcare professional and patient. All data can be stored for later review. CONTRAINDICATIONS:

Do not use on patients with allergies to silver. It is recommended that topical Benadryl be available at all times during use.

Do not use on irritated skin or open wounds.

Technical Service and Support: Contact Precision Biometrics, Inc. at our website: www.MyoVision.com, Email: support@MyoVision.com

23-000-LBL01 Rev E

Page 6 of 60

Warnings and Precautions

Federal (USA) law restricts this device to use or on the order of a physician or licensed practitioner. The device has modules for measuring muscle activity (Static Surface EMG and Dynamic Surface EMG), Skin Temperature and Range of Motion. Consult all accompanying documents for precautionary statements and all other important information. Consult users guide for detailed instructions. Keep the device dry. The presence of liquids on the device may compromise the safety features of the device. Do not use outdoors in rain or wet conditions. Handle with care. Damage to the device may result from misuse or abuse. Sensitive electronic device: Avoid static discharge when possible. Do not operate near strong electrostatic, electromagnetic, magnetic, microwave or radioactive fields. Interference from external sources can affect the results. Use only with MyoVision approved computer hardware, and with MyoVision approved batteries and AC adapters. Immediately discontinue use if skin irritation results from use. Electrodes are for single use only. Do not reuse. Tipping the optional cart greater than 10 degrees may result in physical danger to the user. Immediately contact technical support if the devices performance appears compromised. Precision Biometrics, Inc. guarantees the safety, reliability and performance of the device if and only if worked on by Precision Biometrics, Inc. technicians. If the device has been tampered with, the warranty is void. Certain components contain a Li-Ion battery. Recharge using only the MyoVision charging cable. The battery requires that the device be stored and used in a temperature range of between 5 and 65 degrees Celsius. Storing or operating the device outside this temperature range voids the warranty and can compromise the safety of the device. DISCLAIMER: To the full extent permissible by applicable law, Precision Biometrics, Inc. makes no warranties, expressed or implied, as to the quality and performance of this product including but not limited to, any implied warranty of applicability or fitness for a particular purpose. Precision Biometrics, Inc. shall not be liable for any 23-000-LBL01 Rev E Page 7 of 60

damages of any kind arising from the use of this equipment, including, but not limited to direct, indirect, incidental, punitive, and consequential damages resulting from any defect, failure or malfunction, whether a claim for such damages is based upon theory of warranty, contract, tort, or otherwise. No representative, agent, or licensed practitioner is authorized to waive this disclaimer. This device is intended for use by licensed health care providers only. LIMITED WARRANTY: Precision Biometrics, Inc. warrants the device against failure of materials and workmanship for one year from the date of delivery, provided the device has been properly cared for, and has not been abused. Details of this warranty can be found at the end of this document. Operating this device with equipment, sensors or electrodes not approved by Precision Biometrics, Inc. constitutes an invalidation of this warranty.

Device Classifications
Device classifications, fitness for a particular purpose and statement with regard to intended purchasers Classifications, per IEC/UL/CSA/EN 60601-1: - Class I / Internally Powered - IPX0 - Equipment not suitable for use in the presence of flammable mixtures - Continuous Operation

ScanVision Static sEMG DynaVision Dynamic sEMG FlexVision Range of Motion ThermoVision Thermograph

The following have Type BF Applied Parts:

ScanVision Static sEMG DynaVision Dynamic SEMG

23-000-LBL01 Rev E

Page 8 of 60

The following have Type B Applied Parts:

FlexVision Range of Motion ThermoVision Thermograpy

3G Wirefree PhysioMonitor and SoloVision

The devices which provide the computer interface and communicate with the computer via USB cable and transmits all data from measuring devices to PC.

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

23-000-LBL01 Rev E

Page 9 of 60

Power Supplies and Proper Use and Care of Batteries

Rechargeable Batteries:
When not in use, rechargeable batteries should be kept in the battery charger at all times in order to properly maintain the battery.

Storage of Batteries If Device Is Not Used For Long Period of Time:

TM

Batteries should be removed from the devices that have removable batteries (ScanVision and DynaVision ) if not used for an extended period of time (over 2 months). Follow instructions for storage of rechargeable batteries above or with non-rechargeable batteries so that there are no metal devices which can short out the batteries by touching the positive or negative terminals of the batteries.

TM

Battery Care For FlexVisionTM and ThermoVision Devices:

The FlexVision and ThermoVision use a non-removable, rechargeable battery. Therefore, if stored for long TM periods of time or when not in use, make certain to plug in the charging cable from the PhysioMonitor ROM TM CHRG to keep the FlexVision and ThermoVison charged. Make sure the PhysioMonitor is plugged in with the Power Adapter, PBI Part # PB-204.This will maintain proper battery health.
TM

Batteries and Power Supplies:

ScanVision Milliamps)
TM

: 2 AAA Batteries. Rechargeable NIMH (2.4 Volts, 2400 Milliamps), Alkaline: (3 Volts, 1200

DynaVision : 3 AA Batteries. Rechargeable NIMH (4.5 VOLTS, 2400 Milliamps), Alkaline: (3 Volts, 1800 Milliamps) FlexVision : Internal non-user-replaceable (must be returned to factory) Lithium Polymer Battery, 5 volts, 650 Milliamps ThermoVision: Internal non-user-replaceable (must be returned to factory) Lithium Polymer Battery, 5 volts, 650 Milliamps PhysioMonitor
TM TM

TM

:PBI Part # PB-204 Medical Grade Power Adapter 5 VDC, 4-6A

Environmental Conditions for Transport and Storage: - Temperature range must stay between 5 and 65 Celsius - Relative humidity should stay within 10% and 100% - Atmospheric Conditions: Between 500 and 1060 hPa
o o

Measurement Information

Device Accuracy Frequency Response Input Resistance Input Range A/D Conversion Sampling Rate

DynaVision 0.12 microvolts 25-253 Hz

ScanVision 0.12 microvolts 25-253 Hz

FlexVision 1 degree n/a

ThermoVision 0.1 degree n/a n/a 30-38 Celsius 8 bit 16 ms/channel

1,000,000 Meg ohms 1,000,000 Meg ohms n/a 0.1 1500 microvolts 0.1 -1500 microvolts 12 bit 16ms / channel 12 bit 16ms / channel 1 degree 10 bit 180 ms/channel

23-000-LBL01 Rev E

Page 10 of 60

Explanation of All Labeling

FLEXVISION
TM

FRONT LABEL Power LED explained on rear label.

Connection Status LED explained on rear label.

0 LED at all 4 points on device (0, 90, 180, 270 degrees)

Symbol means power off.

Symbol indicates power on.

FLEXVISION

TM

REAR LABEL Connect Status Connect Switch is used to connect to base Charge Jack is where charging cable is plugged in Charge Indicator LED

Battery Level

Select Switch is used to TM set two FlexVisions so that one is considered the Main and the other is the Auxiliary.

Connection Status LED Green = Connected Flashing Red = Disconnected

23-000-LBL01 Rev E

Page 11 of 60

ScanVision Static Scanning sEMG:

Battery Level Green = OK Red = Low Flashing Red = Critically Low

Connect Status

Start Button

Select Switch

Connect Switch

Symbol means power OFF

Symbol means power ON

DynaVision Dynamic sEMG Labeling:

CH stands for Channel. CH 1, 2, 3, 4 with two lead wires plugged in per channel.

GND represents the Ground where the black lead wire is plugged in.

Start Button

23-000-LBL01 Rev E

Page 12 of 60

ThermoVision Labeling:
Power Switch

Battery Level Green = OK Red = Low Flashing Red = Critically Low

Charge Cable PBI Part # PB-220

Connect Switch

Power

Charge Cable PBI Part # PB-220

Power Switch

Connect Status

23-000-LBL01 Rev E

Page 13 of 60

PhysioMonitor Labeling:
AUX (not used), for future

Power LED Green = ON Not Lit = OFF

Muscle Tester Jack where ForceVisionTM plugs in

Active Devices LED lights indicate how many devices are supported

Computer Connect LED Green when connected to computer Red when not connected to computer

Power Supply: PBI part # PB-201

USB Cable to PC

Power Switch

Charge Cable PBI Part # PB-220

23-000-LBL01 Rev E

Page 14 of 60

SoloVision Labeling:

USB Cable to PC

Power Supply: PBI part # PB-201 Active Devices LED lights Green when the appropriate device(s) is bound Not lit when devices are not bound or when they are not turned on

Charge Cable PBI Part # PB-220

Manual Bind Switch

Computer Connect LED Green when connected to computer Not lit when not connected to computer

DX defines the Internal Radio of the SoloVision. DX can be D4, D5, D6 or D7 D4 = ThermoVision D5 = FlexVision D6 = DynaVision D7 = ScanVision

23-000-LBL01 Rev E

Page 15 of 60

This label appears on each PBI manufactured device shown above.

Attention, consult accompanying documents

Equipment ON

Equipment OFF

Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided. - Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. This Product is intended for use in the electromagnetic environments specified. - The end user of this product should assure it is used in such an environment. - Portable and mobile RF Communications equipment (cell phones) should not be used at close distances - Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. To avoid excessive leakage current transfer to patients, do not touch the equipment communication ports and the patient at the same time. To isolate the equipments circuits electrically from the supply mains, disconnect the power cord.

23-000-LBL01 Rev E

Page 16 of 60

1
Software and Hardware Installation
This section will aid you in getting your system up and running as quickly as possible. Additional sections will include information specific to the various devices you will be using.

Chapter

Install the software prior to installing hardware. If you ordered the computer with the software installed, you simply have to double click on the yellow MyoVision software icon on your desktop. For systems that do not have the software already installed, follow the Quick Install Sheet that came with your system. To properly set up the hardware, you can use the HW Setup Wizard under Help or view the setup video by clicking the Training icon in the software. This section includes some hardware setup instructions for devices added after initial set up. The following system requirements must be met prior to software installation. The computer must have: A Microsoft Windows logo affixed to the computer: Designed for Windows XP or Designed for Windows Vista or Designed for Windows 7. The operating system which matches the logo on the computer must be installed (in other words, systems designed for Windows XP running Vista are not supported due to significant hardware requirements for Windows Vista). At least 512MB of RAM for XP, 1GB for Vista, and 1GB for Windows 7. At least 1.5 GB available space on the hard drive for XP. At least 15 GB available space on the hard drive for Vista. At least 16 GB available space on the hard drive for Windows 7.

Install the MyoVision software on your computer. You must meet the minimum requirements presented on the Quick Install sheet which came with your system. Follow the quick install instructions for proper installation.

23-000-LBL01 Rev E

Page 17 of 60

Basic Software Setup Prior To First Use Prior to first use, it is recommended that you: Enter your office and doctor information and, if you have a ThermoVision, enter the calibration values. 1. Entering Office Information Click Setup, Doctor Information and enter your Doctor Name by clicking Add. Click OK and enter your clinic information. Click OK. Now this information will appear on all printed reports.

2. Calibration of ThermoVision / Thermoglide Unit Note: Calibration of sEMG is performed at the factory, and is not required. The Range of Motion device is calibrated prior to each use as prompted by the software. Yearly calibration of the ROM and sEMG devices may be required. If installing the ThermoVision, click Setup, Calibrate Thermography and enter the values found on the Calibration Sheet which came with the ThermoVision unit.

For a list of up-to-date software tips and tricks, go to www.MyoVision.com under Support and FAQs. Download and print the New Software Features. TIP: Dont forget to run the Hardware Setup Video in the MyoVision Software to help you set up your hardware. Offices With More Than One 3G WireFree System Some offices have more than one MyoVision WireFree System installed. It is recommended that these systems be color-coded so that the devices are not accidentally swapped between the systems. For example, put a blue dot on all of the devices for System 1 and a green dot on all of the devices for System 2. SoloVision or PhysioMonitor There are two options for 3G System Hubs, SoloVision or PhysioMonitor. These provide the computer interface for 3G WireFree devices. There can only be one System Hub connected to the computer.

23-000-LBL01 Rev E

Page 18 of 60

The SoloVision provides a single device connection to the computer. The PhysioMonitor provides multiple device connections to the computer. The use is the same regardless of the System Hub chosen. The difference is that only one device type can be used with the SoloVision whereas the PhysioMonitor provides simultaneous connections for more than one device. The Setup is slightly different. Initial SoloVision Setup Instructions Make certain the MyoVision software has been installed prior to hardware setup. You can confirm this by making certain that the yellow MyoVision Software Icon is on your desktop. 1. You must exit the MyoVision software prior to setting up the hardware. Also exit any other software prior to installation.

2. Remove the SoloVision and the USB cable from the box.

3. Plug the USB cable into the SoloVision where marked USB.

4. With the computer turned on, and fully booted up, make sure to exit the MyoVision software (if open). Plug the other end of the USB into an available USB port on the computer.

Binding the 3G Devices to the SoloVision 1. Make certain the SoloVision is connected to the PC via the USB port and the BIND LED is lit. 2. You must exit the MyoVision software prior to setting up the hardware. Also exit any other software prior to installation. 3. Turn on the corresponding device(s) to the SoloVision; a DynaVision, ThermoVision, a pair of FlexVisions or a pair of ScanVisions. 23-000-LBL01 Rev E Page 19 of 60

4. Enter the MyoVision Software by double clicking the yellow MyoVision Icon on the desktop. 5. Click SETUP, SETTINGS, 3G DEVICES. The MyoVision 3G Device Settings screen appears.

6. Use a paperclip or a pen and push the bind button on the desired device. 7. Within the next 10 seconds, take a paper clip or a pen and push the Bind Button in the SoloVision. 8. The screen will indicate that the process is complete when the indicator for the device changes from red to green.

Initial PhysioMonitor Setup Instructions Make certain the MyoVision software has been installed prior to hardware setup. You can confirm this by making certain that the yellow MyoVision Software Icon is on your desktop. 1. You must exit the MyoVision software prior to setting up the hardware. Also exit any other software prior to installation.

2. Remove the PhysioMonitor, the power adapter and the USB cable from the box.

23-000-LBL01 Rev E

Page 20 of 60

NOTE: Power adapter may vary according to region (North American power adapter is shown here).

3. Plug the power adapter into the PhysioMonitor, and the other end into a three prong Surge Protector power strip. No two prong adapters are allowed. You must have grounded AC power source which allows two power connections and a ground. 4. Plug the USB cable into the PhysioMonitor where marked USB.
PhysioMonitor with AC Adapter and USB plug

5. With the computer turned on, and fully booted up, make sure to exit the MyoVision software (if open). Plug the other end of the USB into an available USB port on the computer.

6. Turn ON the PhysioMonitor. Wait for the computer to enumerate. You will see at the bottom right all the devices install automatically. It may take up to 30 seconds the first time it is setup. Once enumerated you can move on to setting up each device you will be using. NOTE: The Power switch for the PhysioMonitor should be left in the ON position at all times. This allows recharging of the FlexVision and ThermoVision devices.
Leave power switch in "ON" position at all times.

23-000-LBL01 Rev E

Page 21 of 60

FlexVision Setup Important note: Leave the 3G System Hubs Power Switch in the ON Position so that USB ports function and the FlexVision devices are charged. Important note: Turn off all other system devices and cell phones within 15 feet of the 3G System Hub. The FlexVision devices are powered by internal lithium ion batteries, and utilize a Y charging cable connecting both devices to the 3G System Hubs Charging jack marked ROM CHG on the back of the 3G System Hub. 1. Plug the single end of the Y cable into the jack marked ROM CHG on the rear of the 3G System Hub. Make sure to leave the 3G System Hubs switch in the ON position at all times. 2. Plug the two Y ends into both FlexVision devices in the jacks marked CHG on the rear of the FlexVision devices.
Note that the Charge Indicator LED right next to the charging cable jack on the FlexVision, will light up orange when charging, turning green when fully charged. Charging can take up to 4 hours, but the device is functional with only a 30 minute charge.

Charging the FlexVision

3. The FlexVision power switch should be left in the ON position at all times, and is provided only to turn off the devices if being transported. If the red START buttons are not pressed, the devices will automatically shut off, and save power.

NOTE: It is recommended that you leave the POWER switches in the ON position but make certain that they are stored when not used such that the red buttons are not pressed, as this will turn the power on (unless the charging cable is powered on and plugged in). Turn the power switch to the OFF position to transport devices, or when shipping. When being charged, they automatically are turned off so the red button will not turn on the device. NOTE: Make certain to charge devices daily to ensure properly charged devices. Feedback is provided via the on-screen battery status indicator prior to each test, providing significant warning of low battery power.

23-000-LBL01 Rev E

Page 22 of 60

Setting FlexVision Devices to Main and Aux (Not needed in most cases) Confirm the FlexVisions are set as MAIN and AUX. One at a time, turn each FlexVision over so you are viewing the side of the device. Look for the SELECT SWITCH to the left below the (!) mark. The MAIN device (the unit with the yellow label on the front for those with a yellow label) should have the SELECT switch set in the UP position. The Aux device (the FlexVision without the yellow label) in the DOWN position. Up position is MAIN (yellow round If not set properly, use the end of a pen to move the switch to the UP position for the MAIN and DOWN position for the AUX unit.
sticker on front marks main). Down position is AUX

NOTE: YOU MUST HAVE ONE SET AS MAIN, AND THE OTHER SET AS AUX FOR THE DEVICES TO FUNCTION PROPERLY. Binding FlexVision Devices IMPORTANT NOTE: Always leave the 3G System Hub in the ON position, with the USB connected to the computers USB port prior to entering the MyoVision software. Prior to Binding each FlexVision device, make sure that they have been charged for at least 20 minutes prior to binding. IMPORTANT NOTE: Turn off all other system devices and cell phones within 15 feet of the 3G System Hub. IMPORTANT NOTE: Use the FlexVision devices within 15 feet of the 3G System Hub. 1. Make sure the MAIN POWER switch is turned to the ON position for the devices you want to CONNECT to the 3G System Hub. 2. Enter the MyoVision Software by double clicking the yellow MyoVision Icon on the desktop. 3. Click SETUP, SETTINGS, 3G DEVICES. The MyoVision 3G Device Settings screen appears. 4. Press one of the red buttons on the Main FlexVision. The Main device is the one with the Yellow dot on the front (the SELECT switch in the UP position). 23-000-LBL01 Rev E Page 23 of 60

5. The screen will indicate that the process is complete when the indicator for the Main FlexVision device changes from red to green.

6. Now press one of the red buttons on the Aux FlexVision. The Aux device is the one without the Yellow dot. (The SELECT switch on the Aux device is in the DOWN position.) 7. The screen will indicate that the process in complete when the indicator for the Aux FlexVision device changes from red to green.

ScanVision Setup Each ScanVision device is powered by 2 AAA batteries. Alkaline Batteries are recommended.

1. To initially place the batteries in the devices, unscrew the thumbscrew on the bottom of each device, and place the batteries in the orientation following the guide showing (+) and (-) in the battery compartment, with red straps placed for easy removal of batteries as shown. Replace battery door cover and hand-tighten the thumbscrew. Do not over tighten, as there is no need to have this screw tight. 2. Turn the MAIN POWER to the device on by using a pen and sliding the PWR switch to the ON position for both ScanVision devices. This is a Travel switch, and is used when moving the device for screenings, or when shipping to cut all power to the device. This prevents the START button presses from turning the device on inadvertently when being transported.
NOTE: Leave the main Power switch in the ON position, but make certain to store the ScanVision

23-000-LBL01 Rev E

Page 24 of 60

devices such that the Start button is not pressed when not being used.

Setting ScanVision Devices to Left and Right (Usually not needed) Confirm the ScanVisions are set as Left and Right. One at a time, turn each ScanVision so you are viewing the side of the device. Look for the SELECT SWITCH. The Left device (the unit with the yellow label on the front for those with a yellow label) should have the SELECT switch set in the UP position. The Right device (the ScanVision without the yellow label) in the DOWN position. If not set properly, use the end of a pen to move the switch to the UP position for the Left and DOWN position for the Right unit.

NOTE: YOU MUST HAVE ONE SET AS LEFT, AND THE OTHER SET AS RIGHT FOR THE DEVICES TO FUNCTION PROPERLY.

Place yellow label on LEFT ScanVision if not already marked. Binding ScanVision Devices IMPORTANT NOTE: Always leave the 3G System Hub in the ON position, with the USB connected to the computers USB port prior to entering the MyoVision software. IMPORTANT NOTE:Turn off all other system devices and cell phones within 15 feet of the 3G System Hub. IMPORTANT NOTE:Use the ScanVision devices within 15 feet of the 3G System Hub. 1. Make sure the MAIN POWER switch is turned to the ON position for the devices you want to CONNECT to the 3G System Hub 2. Enter the MyoVision software by double clicking the yellow MyoVision Icon on the desktop. 3. Click SETUP, SETTINGS, 3G DEVICES. 23-000-LBL01 Rev E Page 25 of 60

4. The MyoVision 3G Device Settings screen appears. 5. Press the START on the LEFT FlexVision. The LEFT device is the one with the Yellow dot on the front, with the SELECT switch in the UP position. 6. The screen will indicate that the process is complete when the indicator for the LEFT ScanVision device changes from red to green.

7. Now press the START on the RIGHT ScanVision. The RIGHT device is the one without the Yellow dot. The SELECT switch on the RIGHT device is in the DOWN position. 8. The screen will indicate that the process in complete when the indicator for the RIGHT ScanVision device changes from red to green.

DynaVision Setup Installing Batteries The DynaVision device is powered by 3 AA batteries. Alkaline rated batteries are recommended. To insert batteries follow these steps. 1. Remove the back battery door by applying pressure on the door lock downward with your thumb and pull back on it, removing the door.

2. Place batteries in following the guide on the back door making certain to replace the straps below batteries for easy removal.

23-000-LBL01 Rev E

Page 26 of 60

3. Once you have inserted batteries, turn the TRAVEL POWER Switch to the ON position, by using a pen and moving the switch as shown.

NOTE: This switch may be left in the ON position at all times. Make certain the device is not stored or left in a position where the white START button is pressed (when not being used). The Power switch was designed to turn off battery power when transporting or shipping the device, so that pressing the START button will not power up the device. The device will shut off

Binding The DynaVision Device IMPORTANT NOTE: Always leave the 3G System Hub in the ON position, with the USB connected to the computers USB port prior to entering the MyoVision software. IMPORTANT NOTE:Turn off all other system devices and cell phones within 15 feet of the 3G System Hub. 1. Make sure the MAIN POWER switch is turned to the ON position for the DynaVision you want to CONNECT to the 3G System Hub.

2. Enter the MyoVision Software by double clicking the yellow MyoVision Icon on the desktop. 3. Click SETUP, SETTINGS, 3G DEVICES. The MyoVision 3G Device Settings screen appears. 4. Press the white START button on the DynaVision. 5. The screen will indicate that the process is complete when the indicator for the DynaVision device changes from red to green.

23-000-LBL01 Rev E

Page 27 of 60

ThermoVision Setup Important note: Turn off all other system devices and cell phones within 15 feet of the 3G System Hub. The ThermoVision device is powered by internal lithium ion batteries, and utilizes a charging cable connecting the device to the jack marked ROM CHG on the back of the 3G System Hub. 1. Plug the single end of the Y cable into the jack marked ROM CHG on the rear of the 3G PhysioMonitor System Hub. Make sure to leave the 3G System Hubs switch in the ON position at all times.

2. The cable has two ends; one with an adapter and one without. Plug the end without the adapter into the jack marked CHARGE JACK on the side of the ThermoVision device.
Adapter end. Can be used to connect the FlexVision charging cable. Charging the ThermoVision

Note that the Charge Indicator LED right next to the CHARGE JACK on the ThermoVision, will light up orange when charging, turning green when fully charged. Charging can take up to 4 hours, but the device is functional with only a 30 minute charge.

3. The ThermoVision power switch should be left in the ON position at all times, and is provided only to turn off the devices when being transported. If the trigger is not pressed, the device will automatically shut off, saving power.

NOTE: It is recommended you leave the POWER switch in the ON position. When not in use, however, make sure the trigger is not pressed. The trigger press turns the power on to the device. Turn the power switch to the OFF position to transport devices, or when shipping. While being charged, the device is automatically turned off, so the trigger will not turn on the device.

23-000-LBL01 Rev E

Page 28 of 60

NOTE: Make certain to charge devices daily to ensure properly charged devices. Feedback is provided via the on-screen battery status indicator prior to each test, providing significant warning of low battery power.

Binding The ThermoVision Device IMPORTANT NOTE: Always leave the 3G System Hub in the ON position, with the USB cable connected to the computers USB port prior to starting the MyoVision software. Prior to Binding the ThermoVision device, make sure it has been charged for at least 30 minutes. IMPORTANT NOTE: Turn off all other system devices and cell phones within 15 feet of the 3G System Hub. 1. Enter the MyoVision Software by double clicking the yellow MyoVision Icon on the desktop. 2. Click SETUP, SETTINGS, 3G DEVICES. The MyoVision 3G Device Settings screen appears. 3. Holding the ThermoVision device in your hand like a gun, pull the trigger. 4. The screen will indicate the process is complete when the indicator for the ThermoVision device changes from red to green.

23-000-LBL01 Rev E

Page 29 of 60

Chapter

2
3G ScanVision Static sEMG & ThermoVision Procedures
This section will cover basic procedural tips for ensuring accurate and reproducible data. For a research paper on the topic, and up-to-date information visit: www.MyoVision.com under Support and/or Training. Also refer to the Surface EMG FAQs under Support at www.MyoVision.com. For videos covering most aspects of proper testing technique, click on the Video button in the software. Further more in-depth videos on interpretation are available on-line at www.MyoVision.com.

Static Surface EMG Procedures: Preparation

1. Confirm that your electrodes have not worn out by visually inspecting them. If your electrodes have worn out (they change from a dark dull matte finish to lighter, shiny or light brown, or with white spots you need to replace them). Worn electrodes prevent proper skin contact. Worn electrodes will cause trouble achieving stable readings. 2. To be safe, replace Static Electrodes at minimum every 6 months or after approximately 200 tests. Electrodes that are light gray, blotchy or have turned shiny should be replaced immediately. 3. Make certain to turn any Cell phones in the room you are testing to the OFF position. The electrical interference created by the cell phone will cause high readings. The Cell phone needs to be powered off, and not just in silent mode. Always remove shoes, as shoe height varies from visit to visit and can dramatically affect readings. 23-000-LBL01 Rev E Page 30 of 60

4. Make sure that you are not testing beneath an air conditioning duct, as air blown on the patient will create static electricity and high readings. 5. Wipe the skin with alcohol along the paraspinals starting from the cervical left side, rubbing down the spine, and then the right side and down the spine. There is no need to rub hard. A simple single wipe down the skin once or twice at the most is usually sufficient. Dab the skin dry with a dry paper towel before testing to make certain that the skin is dry prior to testing. 6. Remove a QuickScan Pad from the QuickScan Pad Jar, replacing the lid. Place the pad on TOP of the QuickScan pad jars lid. It is crucial to place it on top of the jars lid, and NEVER place the probe inside the jar. This will get the liquid on the probe, potentially damaging it. 7. Never rub QuickScan liquid on the patients skin with the pad. Always instead, touch the electrodes to the pad momentarily prior to placing them on the skin. PERFORMING A 3G W IREFREE SCANVISION FS STATIC SEMG EXAM (FULL SPINE STATIC SEMG) The software provides the user with prompts using both voice and on-screen markings which inform the user where to place the probes on the patients skin. The ScanVision probes are marked left and right by having a yellow sticker on the rear (opposite end from the electrodes) of the left ScanVision probe, with the right probe being the probe without a sticker. Testing is performed by placing the ground (center electrode with the spring action) at the location the software prompts the user. The device is placed on the skin with the left probe approximately an inch and a half from the center of the spine, with the electrodes above the paraspinal muscles (the muscles found bilaterally to the left and right sides of the spine). The center ground has a spring action so that it adapts to the bodys curves, and allows for proper skin contact. Performing the test: Requires a jar of QuickScan pads, and two ScanVision probes (left probe marked with yellow marker). 1. 2. 3. 4. Place one pad on top of QuickScan pad jar DO NOT PUT PROBE IN JAR! Remove patients shoes and shirt. Cell phones should be turned Off. Clean skin with alcohol by wiping down left and then right paraspinals from the neck to the base of the low back. 5. Dab skin dry with paper towel. 6. Have patient stand in neutral posture, hands to side. Do not let them hold their hands together 7. Mentally determine placement of probes by breaking spine into cervical, thoracic and lumbar region, dividing by number of readings to take. This is

23-000-LBL01 Rev E

Page 31 of 60

done to avoid having to mark levels. There is no need to mark levels since a general measure of the region is all that is required. 8. After entering patient last, first ID and Gender, Select the 3G FS Static sEMG protocol in the software. When the screen appears showing RED Link Quality bars with a RED X, press and release the START buttons on both left and right ScanVisions.

9. Once the Link Quality bars turn GREEN, press and hold ONE START button for 2 seconds, and release to enter the Perform Scan Screen

10. Touch one probe at a time to the QuickScan pad and make sure all three electrodes make contact with pad. 11. Touch probe to skin NEVER on hair (move under ear if needed), and down below C2 even if C2 appears on screen). The Site presented is (i.e. C2) is where the center spring-loaded ground is placed on with probes placed bilaterally about the spine at this level.

12. Watch screen. If readings drop quickly, you have good contact with skin: Press and release LEFT OR RIGHT button (NOT BOTH), listening for CLICK of button. DO NOT HOLD DOWN THE BUTTON, but just press and release. 23-000-LBL01 Rev E Page 32 of 60

13. Once you have pressed and released the single button DO NOT REMOVE THE PROBES from the skin. The button press and release initiates the AutoScanning process whereby the computer automatically stores the data from the top level, then the bottom level (shown as top bar and bottom bar on screen) one at a time when the readings are determined by the computer to be stable. 14. IF the readings do NOT drop right away, pick up and move probe over slightly, touch down again, allowing reading to store. 15. When readings have stored, the computer will prompt you by moving the bars to the next level and by providing a voice prompt for this level. 16. Remove probe from skin, and follow the procedure from step #10-15 until all sites have stored. 17. When done testing, DAB electrodes on end of probes with alcohol to clean them for next patient. NOTES: 1. In cases where readings are very high, and will not stabilize (meaning autoscan will not store data automatically, you may press the button a 2nd time to store the data. 2. In the rare event that the patient sways upon touching the skin, wait for them to return to neutral prior to pressing and releasing the single button. In general, autoscan will not store data until the sway stops anyhow, and was designed to take sway into account. 3. To REDO a site, move the mouse cursor over the center of the spine at the level you have chosen to redo, and click on it. It will allow you to redo that site. If you have done multiple sites prior to redo, you may have to click on the next site to test to continue testing. PERFORMING A 3G W IREFREE SCANVISION QUICKSCREEN STATIC SEMG EXAM (3G QUICKSCREEN STATIC CERVICAL AND LUMBAR EXAM) This test is the same basic test as in 3.2.7.3 but is a quick version of it for screenings only, so is not as detailed. It was designed for the Cervical and Lumbar exam only skipping sites in the middle of the back. The software provides the user with prompts using both voice and on-screen markings which inform the user where to place the probes on the patients skin. The ScanVision probes are marked left and right by having a yellow sticker on the rear (opposite end from the electrodes) of the left ScanVision probe, with the right probe being the probe without a sticker. Testing is performed by placing the ground (center electrode with the spring action) at the location the software prompts the user. The device is placed on the skin with the left probe approximately an inch and a half from the center of the spine, with the electrodes above the paraspinal muscles (the muscles found bilaterally to the left and right sides of the spine). The center ground has a spring action so that it adapts to the bodys curves, and allows for proper skin contact. 23-000-LBL01 Rev E Page 33 of 60

Performing the test: Requires a jar of QuickScan pads, and two ScanVision probes (left probe marked with yellow marker). 1. Place one pad on top of QuickScan pad jar DO NOT PUT PROBE IN JAR!! 2. Cell phones should be turned Off. 3. Clean skin with alcohol by wiping down left and then right paraspinals from the neck to the base of the low back. 4. Dab skin dry with paper towel. 5. Have patient stand in neutral posture, hands to side. Do not let them hold their hands together 6. Mentally determine placement of probes by breaking spine into cervical, thoracic and lumbar region, dividing by number of readings to take. This is done to avoid having to mark levels. There is no need to mark levels since a general measure of the region is all that is reqiured. 7. Select the 3G QuickScreen Static protocol in the software. When the screen appears showing RED Link Quality bars with a RED X, press and release the START buttons on both left and right ScanVisions. 8. Once the Link Quality bars turn GREEN, press and hold ONE START button for 2 seconds, and release to enter the Perform Scan Screen. 9. Touch one probe at a time to the QuickScan pad and make sure all three electrodes make contact with pad. 10. Touch probe to skin NEVER on hair (move under ear if needed), and down below C2 even if C2 appears on screen). The Site presented is (i.e. C3) is where the center spring-loaded ground is placed on with probes placed bilaterally about the spine at this level. 11. Watch screen. If readings drop quickly, you have good contact with skin: Press and release LEFT OR RIGHT button (NOT BOTH), listening for CLICK of button. DO NOT HOLD DOWN THE BUTTON, but just press and release. 12. Once you have pressed and released the single button DO NOT REMOVE THE PROBES from the skin. The button press and release initiates the AutoScanning process whereby the computer automatically stores the data from the top level, then the bottom level (shown as top bar and bottom bar on screen) one at a time when the readings are determined by the computer to be stable. 13. IF the readings do NOT drop right away, pick up and move probe over slightly, touch down again, allowing reading to store. 14. When readings have stored, the computer will prompt you by moving the bars to the next level and by providing a voice prompt for this level. 15. Remove probe from skin, and follow the procedure using the QuickScan liquid for the rest of the measures. 16. When done testing, DAB electrodes on end of probes with alcohol to clean them for next patient. 23-000-LBL01 Rev E Page 34 of 60

17. Press F6 to review the results on the screen, or F7 to print them. Press F5 to begin another QuickScreen procedure. NOTES: 1. In cases where readings are very high, and will not stabilize (meaning autoscan will not store data automatically, you may press the button a 2nd time to store the data. 2. In the rare event that the patient sways upon touching the skin, wait for them to return to neutral prior to pressing and releasing the single button. In general, autoscan will not store data until the sway stops anyhow, and was designed to take sway into account. To REDO a site, move the mouse cursor over the center of the spine at the level you have chosen to redo, and click on it. It will allow you to redo that site. If you have done multiple sites prior to redo, you may have to click on the next site to test to continue testing. NOTE: NEVER REMOVE THE PROBE FROM THE SKIN UNTIL PROMPTED BY THE SOFTWARE. MAINTAIN EVEN PRESSURE (lightnot enough to move the patient, but enough to make good contact). NOTE: If you press the button after the readings drop and you do not hear a click sound indicating that Autoscan has been initiated it means that the button press was not registered. Press the button a second time to initiate the Autoscanning function. NOTE: If you do not get readings to drop immediately this may be caused by poor contact with the skin. Simply lift up and place the probe down slightly away from the spine (may take a couple of touch downs) to locate an area of better contact. NOTE: Never touch the probe down to an area where there is hair. You may move the probe under the ear if necessary as the device is measuring a region approximately two inches in diameter, and you will still get relevant readings. NOTE: If testing on individuals with considerable hair on their backs, and if the QuickScan pad liquid technique does not allow for readings to stabilize, you can either shave the region or use Signa Cream (a bottle comes with each package). Simply open the cap, and place a small dab of Signa cream on each electrode. Touch down to the skin and gather readings as you would with QuickScan Liquid, although you may only have to place the cream on the electrodes at every 2nd or third measurement. SPECIAL NOTE: When testing patients with extremely high muscle activity, the Autoscanning function may not store the data as it is too variable with these patients. If you are comfortable that the reading is truly high legitimately, press the button a second time to override the Autoscan feature and store the data. 23-000-LBL01 Rev E Page 35 of 60

To Redo a Static Site In Testing Mode While testing, if you would like to redo a site (if for example readings do not appear accurate or you would like to verify that they are), simply click on the spine at the site you would like to retest. When complete, click the site you would like to continue with if the software does not automatically continue to the next site. 1. Continue down the spine until all levels have been stored. NOTE: All data will be stored automatically once you have completed the test. 2. If the NEXT button is shown in the upper right live, click it to continue to the next test you have selected in the protocol. If the NEXT button is grayed out, click on the REVIEW button to view the results. Post Static Test Procedure: Cleaning Electrodes Once you have finished with testing the patient, clean electrodes by dabbing them with alcohol after each patient is tested. Do not rub electrodes with the alcohol pad as it will wear out the electrodes prematurely. IMPORTANT! Once monthly or if you see a buildup of bluish liquid on plastic piece or metal female connector where static electrodes are attached to the probe, remove electrodes, and clean the plastic piece and metal electrode connector with an alcohol wipe. This is done to reduce buildup of the QuickScan liquid from the probe itself.
Software Features:

Reviewing Tests 1. Click OPEN if test is not in the Review Screen. 2. You may click the Horizontal Tab in the upper right of the screen to change between Normal and Balance modes. This allows you to view the data in terms of the actual readings or do a left-right comparison. In Normal mode, the data shown is in microvolts, with the percent imbalance as the percentage difference between one side and the other for each level. COMPARING / OVERLAYING STATIC AND/OR THERMO TEST RESULTS 1. To perform a comparison, Click OPEN, type the last name of the patient. 2. Once you have selected the patient, hold the control key (CTRL) and click on the two tests (shown in the box to the right) which you would like to overlay. Instructions are provided in the software at the bottom left of the box which appears. 3. Click SHOW EXAM to view them. Set the SEMG to NORMAL. For the SEMG, the top set of bars at each level is the pre-test. The bottom set of bars is the post-test.

23-000-LBL01 Rev E

Page 36 of 60

PERFORMING A THERMO FS EXAM Make certain the patient has their shirt removed. 1. Wipe the skin with alcohol along the paraspinals starting from the cervical left side, rubbing down the spine, and then the right side and down the spine. There is no need to rub hard. A simple single wipe down the skin once or twice at the most is usually sufficient. Dab the skin dry with a dry paper towel before testing to make certain that the skin is dry prior to testing. 2. Select the protocol Thermo FS 3. Have the patient stand. 4. Pick up the Thermography gun. 5. The software will prompt you with Apply probe to skin. 6. Press the rollers on the Thermography gun against the skin at the low back (approximately the sacrum), making certain the Thermography probes are not touching the skin, and are placed so that they bisect the spine (the left and right probes are equidistant from the center of the spine). 7. Press and hold the button on the probe, count 1-1000 and begin rolling it up the spine taking approximately 15 seconds to roll up the full spine while holding the button. 8. When you have reached the top of the spine and hit the hairline, use your free hand to lift the hair up and out of the way, keeping the patients head upright. 9. Allow the two probes to touch the skin at this point and very slowly roll up until the probes hit the base of the skull. 10. Count 1-1000 and release the button.

23-000-LBL01 Rev E

Page 37 of 60

Chapter

3
General Surface EMG Tips for Dynamic Surface EMG and Range of Motion
This section will cover basic procedural tips for ensuring accurate and reproducible data. For a research paper on the topic, and up-to-date information visit: www.MyoVision.com under Support and/or Training. Also refer to the Surface EMG FAQs under Support at www.MyoVision.com. This assumes that you are using the combined DynaVision with FlexVision Range of Motion Device. For videos covering most aspects of proper testing technique, click on the Video button in the software. Further more in-depth videos on interpretation are available on-line at www.MyoVision.com.

Dynamic Surface EMG Procedures: Properly preparing the patient

1. Only use electrodes from a fresh, sealed pouch with a date code which is current. 2. Confirm that your electrodes have proper gel on them by examining the plastic backing of the strip of electrodes. You can apply slight pressure to the center of the electrode or visually observe that the electrodes are not dry. If the electrodes are dry, you will not be able to Dry, unusable electrode Gelled good gather accurate data. Replace the electrodes with fresh electrode electrodes if dry. 3. Make certain to turn any Cell phones in the room you are testing to the OFF position. The electrical interference created by the cell phone will cause high readings. The Cell phone needs to be powered off, and not just in silent mode. 4. Always remove shoes, as shoe height varies from visit to visit and can dramatically affect readings.

23-000-LBL01 Rev E

Page 38 of 60

5. Make sure that you are not testing beneath an air conditioning duct, as air blown on the patient will create static electricity and high readings. 6. Wipe the skin with alcohol along the paraspinals starting from the cervical left side, rubbing down the spine, and then the right side and down the spine, skipping any area which will not be tested (for cervical and lumbar test, you may skip cleaning the thoracic region. There is no need to rub hard. A simple single wipe down the skin once or twice at the most is usually sufficient. 7. Also wipe the skin where the ground will be placed (the bony prominence of the left or right scapula) 8. Dab the skin dry with a dry paper towel before testing to make certain that the skin is dry prior to testing. 9. For the best results, if you are getting high, flat readings, allow the electrodes to stay on the skin for approximately 6-10 minutes prior to testing. This is normally required only in the cervical spine.

PERFORMING A 3G DYNAROM LUMBAR EXAM UTILILZING THE DYNAVISION DYNAMIC SEMG AND FLEXVISION RANGE OF MOTION DEVICES NOTE: See Video training for a video demonstrating the instructions described below. 1. Make certain you have a set of white lead wires plugged into the DynaVision in Channel 1, a set of red lead wires plugged into the DynaVision in channel 2, and a black ground lead wire plugged into the DynaVision (note: Photo shows extra white and red leads (ch3 &4). where the indicator is for the GND (ground). 2. Attach the belt around the patients waist and place the DynaVisions Belt clip on the belt so the DynaVision sits to the left or right of the center of the spine leaving room for the FlexVision Range of motion devices to be placed along the center of the spine. 3. Remove dynamic electrodes (in the white single use pouch) from the pouch. Using the alligator clips at the end of the lead wires, connect all lead wires to the metal snap connector on the electrodes while still on the plastic backing. Make certain that Channel 1 (white lead wires) are connected to the first two electrodes, Channel 2 (red lead wires) are connected to the 3rd and 4th electrode, and the GND (black) lead wire is connected to the 5th electrode. 4. With the patient bent forward as far as possible without causing pain, attach electrodes for Channel 1 and to L1 and L5 on the left (white lead wires) approximately 1 inch from the spine (above the paraspinal muscles) and Channel 2 to L1 and L5 on the right (red lead wires) symmetrically in comparison to Channel 1. Attach the ground lead wire to the bony prominence to the left of the left scapula (shoulder blade). It is not critical to be exact. 5. Next Select 3G DynaROM Lumbar sEMG Exam. Click OK or double click on the protocol name. 6. When you see the 3G Device Settings Dialog Box you are viewing the 23-000-LBL01 Rev E Page 39 of 60

status of the devices. This prompts you to turn on the devices by pressing and releasing a red button on each of the FlexVision Probes (in this case) and the white button on the DynaVision device.

7. Once you have pressed the buttons for each, the status indicators will turn GREEN and show the actual status of the batteries (in terms of percentage of charge), and quality of the wirefree link (strength of the signal).

8. After turning on each device, click and hold the red button on ONE FlexVision for approximately 2 seconds and release to continue to the test. You can alternatively click on the CONTINUE button to continue on to the testing screen. 9. You will now continue to the Calibration screen for the FlexVision. This ensures that the devices receive the same zero value in relationship to the earth. They must be both placed with all four feet on a flat surface, with both devices facing as shown on the screen in the software (vertically, and in the same plane with each other). 10. Press and release the button on the MAIN device (the unit marked with a yellow round sticker). The software will inform you when calibration is complete. Technically, it does not matter which device you calibrate first, but for ease of use, following the same procedure will save time. Once the main device has been

23-000-LBL01 Rev E

Page 40 of 60

calibrated, press and release one red button on the AUXILIARY FlexVision and hold it still for it to gather calibration information. When calibration has been completed, the CALIBRATED message will appear below both devices. 11. Press for 2 seconds, and release ONE red button to continue on to perform the exam.

12. When you arrive at the Data Collection Screen you will see a graph. The top half of the graph provides you with the Dynamic Surface EMG data. The bottom half of the graph (in black and green) shows the Range of Motion data in degrees. The degrees of motion (difference between MAIN and AUXILIARY FlexVision devices is presented as a digital value in the upper right of the bottom graph. The values in microvolts of each channel of the Dynamic sEMG is presented in the upper left and right corners of the screen, with blue values indicating channels 1 and 3, red channels 2 and 4. 13. To begin a test, press and hold one RED button on the Range of Motion device per the videos in the software training (by clicking the TRAINING button in the software) and follow the instructions in these videos to complete the exam, or continue on to 10 below for instructions for completing the exam. 14. NOTE. When completed with each screen, press one RED FlexVision button on either FlexVision for 2 seconds, and RELEASE this button to move to the next screen. You can see what motion is required in the upper right of the screen, where the procedure name determines the motion required. 15. Holding the FlexVisions between 1st and 2nd fingers in both hands, with your thumb able to press the red button, (label facing you) stand to the side of the patient, and place one FlexVision device with the two feet against the patients Sacrum (low back) when standing. Place the second FlexVision device in the same manner at approximately Thoracic 11 (T11 at the bottom of the mid back). 23-000-LBL01 Rev E Page 41 of 60

16. Press and release the red button on ONE FlexVision to begin the test. You will be having the patient perform three (3) flexions in 30 seconds so plan on 10 seconds per flexion and time the motions appropriately. 17. Tell the patient to drop and hang naturally, with head and hands dropped towards the ground. 18. Once you see the yellow graph at the bottom at its peak, count 1-1000, 2-1000 and PRESS and RELEASE red button to mark full flexion. 19. Have the patient stand back up, and when the graphed line in yellow at the bottom of the screen is at a minimum value, count 1-1000, 2-1000 and PRESS and RELEASE either red button to mark the NEUTRAL position. 20. repeat steps 17 and 18 until 3 complete cycles have completed. 21. If you do not complete the 3 cycles in 30 seconds or must redo an exam, click the CLEAR button and begin again. See videos for detail. 22. To move on to the next screen, PRESS AND HOLD the red button on one FlexVision for approximately 2 seconds, or until you see the next screen appear, and RELEASE the red button at this point. 23. EXTENSION: Now Follow the same procedure from 14-21 but this time, perform 3 extensions (backward bending). 24. LEFT/RIGHT LATERAL FLEXION: NOTE: See video training for demonstration. Now with the patient back in the standing neutral posture, and you are now standing directly behind the patient place the two FlexVisions so that one is at approximately at Thoracic 11 (T11 at the bottom of the mid-back) holding the hockey puck cylinder in your hand, and the back of it is flat against the back, with feet straight down). With your fingers holding the second FlexVision in the same manner as the previous exam, place it so the round head is facing down at the Sacrum, label facing you with the feet facing straight up towards the feet of the other FlexVision. 25. Now, press and release ONE red button to begin the test. You will be completing three lateral flexions within 20 seconds, so time them appropriately. You can always click the CLEAR button to restart the test. 26. Have the patient drop their fingertip to their knee bending to the left only without rotating (pure lateral flexion). When the yellow graph is at its peak and the patient is bent as far as possible to the left, count 1-1000, 2-1000 and PRESS and RELEASE one red button to mark the end range of motion. 27. Return to the center (standing) position and when the yellow graphed readings are at a minimum, count 1-1000, 2-1000 and PRESS and RELEASE one red 23-000-LBL01 Rev E Page 42 of 60

button to mark the center position. Repeat 25 and 26 until all three left lateral flexions are graphed. 28. Press and hold the RED button on the FlexVision for approximately 2 seconds, or the NEXT screen appears. 29. LEFT/RIGHT ROTATION: NOTE: See video under TRAINING button for more detailed demonstration. Due to the technical limitations which prevent the FlexVision device from measuring angle of rotation measure angle of rotation. Therefore, rotation is performed with the DynaVision only and in the seated posture. 30. Have the patient sit in a chair without leaning against the back of the chair. Knees should be approximately at a right angle to the floor. Hold one or both of the FlexVisions in your hand so you can use one of the RED buttons to initiate the exam. 31. Have the patient place their arms with elbows in front of them, arms crossed (the genie position) facing forward. 32. Press ONE red button to begin the exam, asking the patient to rotate as far left as possible, but not beyond any point of pain. When at full left rotation, look at the screen, and when you see a peak reading on the Dynamic graph, PRESS and RELEASE red button to mark the peak. 33. Ask the patient to return to the center. When you see the readings drop on the screen count 1-1000, 2-1000 and PRESS and RELEASE one red button to mark the valley in neutral. 34. Repeat until there are three left rotations. 35. Repeat 31-33 for right rotation. 36. At the last screen press REVIEW to store the data and review. 37. To print the results, click the PRINT button in the upper left of the screen, and select your options, click OK, select your printer and print. PERFORMING A 3G DYNAROM CERVICAL EXAM UTILIZING THE DYNAVISION COMBINED W ITH FLEXVISION RANGE OF MOTION DEVICE. NOTE: See Video training for a video demonstrating the instructions described below. Click SCAN to begin.

23-000-LBL01 Rev E

Page 43 of 60

1. Make certain you have a set of white lead wires plugged into the DynaVision in Channel 1, a set of red lead wires plugged into the DynaVision in channel 2, and a black ground lead wire plugged into the DynaVision where the indicator is for the GND (ground). In addition, plug in a set of white lead wires into channel 3, and a set of red lead wires into channel 4. 2. Attach the belt around the patients chest so that it runs underneath the arms,+ and place the DynaVisions Belt clip on the belt so the DynaVision sits to the left or right of the center of the spine leaving room for the FlexVision Range of motion devices to be placed along the center of the spine. 3. Remove dynamic electrodes (in the white single use pouch) from the pouch. Using the alligator clips at the end of the lead wires, connect all lead wires to the metal snap connector on the electrodes while still on the plastic backing. Make certain that Channel 1 (white lead wires) are connected to the first two electrodes, Channel 2 (red lead wires) are connected to the 3rd and 4th electrode, and the GND (black) lead wire is connected to the 5th electrode. Attach the ground lead wire to the bony prominence to the left of the left scapula (shoulder blade). It is not critical to be exact. Remove another set of 5 electrodes on plastic backing from an unopened white pouch. Connect the white lead wires from channel 3 to the metal snap connectors on two electrodes, and the red lead wires from channel 4 to the metal snap connectors on two additional electrodes, leaving one electrode without a connection. 4. With the patient bent forward as far as possible without causing pain, attach electrodes for Channel 1 and to C4 and T1 on the left (white lead wires) approximately 1 inch from the spine (above the paraspinal muscles) and Channel 2 to C4 and T1 on the right (red lead wires) symmetrically in comparison to Channel 1. Connect the electrodes from channel 3 to the SCMs (one in front of the C4 electrode, and the other down by the adams apple, a half and inch from towards the ear on the left side. Connect the electrodes from channel 4 to the SCMs (one in front of the C4 electrode, and the other down by the adams apple, a half and inch from towards the ear on the right side). 5. Next Select 3G DynaROM Cervical sEMG Exam. Click OK or double click on the protocol name. 6. When you see the 3G Device Settings Dialog Box you are viewing the status of the devices. This prompts you to turn on the devices by clicking a red button on each of the FlexVision Probes (in this case) and the white button on the DynaVision device.

23-000-LBL01 Rev E

Page 44 of 60

7. Once you have pressed the buttons for each, the status indicators will turn GREEN and show the actual status of the batteries (in terms of percentage of charge), and quality of the wirefree link (strength of the signal). 8. After turning on each device, click and hold the red button on ONE FlexVision for approximately 2 seconds and release to continue to the test. You can alternatively click on the CONTINUE button to continue on to the testing screen.

9. You will now continue to the Calibration screen for the FlexVision. This ensures that the devices receive the same zero value in relationship to the earth. They must be both placed with all four feet on a flat surface, with both devices facing as shown on the screen in the software (vertically, and in the same plane with each other).

23-000-LBL01 Rev E

Page 45 of 60

10. Press and release the button on the MAIN device (the unit marked with a yellow round sticker). The software will inform you when calibration is complete. Technically, it does not matter which device you calibrate first, but for ease of use, following the same procedure will save time. Once the main device has been calibrated, press and release one red button on the AUXILIARY FlexVision and hold it still for it to gather calibration information. When calibration has been completed, the CALIBRATED message will appear below both devices.

11. Press for 2 seconds, and release ONE red button to continue on to perform the exam. 12. When you arrive at the Data Collection Screen you will see a graph. The top half of the graph provides you with the Dynamic Surface EMG data. The bottom half of the graph (in black and green) shows the Range of Motion data in degrees. The degrees of motion (difference between MAIN and AUXILIARY FlexVision devices is presented as a digital value in the upper right of the bottom graph. The values in microvolts of each channel of the Dynamic sEMG is presented in the upper left and right corners of the screen, with blue values indicating channels 1 and 3, red channels 2 and 4.

23-000-LBL01 Rev E

Page 46 of 60

13. To begin a test, press and hold one RED button on the Range of Motion device per the videos in the software training (by clicking the TRAINING button in the software) and follow the instructions in these videos to complete the exam, or continue on below for instructions for completing the exam. 14. NOTE. When completed with each screen, press and release ONE red button on the FlexVision to move to the next screen. You can see what motion is required in the upper right of the screen, where the procedure name determines the motion required. 15. Holding the FlexVisions between 1st and 2nd fingers in both hands, with your thumb able to press the red button, (label facing you) stand to the side of the patient, and place one FlexVision device with the two feet against the patients Thoracic 1 (the bump at the base of the neck where the neck transitions to the thoracic area) when standing. Place the second FlexVision device in the same manner at approximately the top of the head. You can perform this test with the patient seated if you cannot reach the top of their head. 16. Press and release the red button on ONE FlexVision to begin the test. You will be having the patient perform three (3) flexions in 30 seconds so plan on 10 seconds per flexion and time the motions appropriately. 17. Tell the patient to drop and hang their head naturally, with head and hands dropped towards the ground. 23-000-LBL01 Rev E Page 47 of 60

18. Once you see the yellow graph at the bottom at its peak, count 1-1000, 21000 and PRESS and RELEASE red button to mark full flexion. 19. Have the patient return the head to neutral, and when the graphed line in yellow at the bottom of the screen is at a minimum value, count 1-1000, 21000 and PRESS and RELEASE either red button to mark the NEUTRAL position. 20. Repeat steps 17 and 18 until 3 complete cycles have completed. 21. If you do not complete the 3 cycles in 30 seconds or must redo an exam, click the CLEAR button and begin again. See videos for detail. 22. To move on to the next screen, PRESS AND HOLD the red button on one FlexVision for approximately 2 seconds, and RELEASE the red button at this point to continue to the next screen. You will always move from screen to screen like this. 23. EXTENSION: Now Follow the same procedure as Flexion but this time, perform 3 extensions (backward bending of head). 24. LEFT/RIGHT LATERAL FLEXION: NOTE: See video training for demonstration. Now with the patient back in the standing neutral posture, and you are now standing directly behind the patient place the two FlexVisions so that one is at approximately at Thoracic 1 with label facing you, either with feet facing up or down holding the hockey puck cylinder in your hand, and the back of it is flat against the back). With your fingers holding the second FlexVision in the same manner as the previous exam, place it on the top of the head with label facing you also, held between your first and middle finger so that you can press and release one of the red buttons with your thumb. 25. Now, press and release ONE red button to begin the test. You will be completing three LEFT lateral flexions within 20 seconds, so time them appropriately. You can always click the CLEAR button to restart the test. 26. Have the patient drop their head (ear to the shoulder) left only without rotating (pure lateral flexion). When the yellow graph is at its peak and the patient is bent as far as possible to the left, count 1-1000, 2-1000 and PRESS and RELEASE one red button to mark the end range of motion. 27. Return to the center (head straight up, neutral) position and when the yellow graphed readings are at a minimum, count 1-1000, 2-1000 and PRESS and RELEASE one red button to mark the center position. Repeat 25 and 26 until all three left lateral flexions are graphed. 28. Press and hold the RED button on the FlexVision for approximately 2 seconds and release so that the NEXT screen appears. 23-000-LBL01 Rev E Page 48 of 60

29. LEFT/RIGHT ROTATION: NOTE: See video under TRAINING button for more detailed demonstration. Left/Right Rotation is performed twice. The first set of left / right rotations are performed measuring Surface EMG only without measuring Range of Motion. This is due to the technical limitations which prevent the FlexVision device from measuring angle of rotation. 30. Hold one or both of the FlexVisions in your hand so you can use one of the RED buttons to initiate the exam. 31. Press ONE red button to begin the exam, asking the patient to rotate their head as far left as possible, but not beyond any point of pain. When at full left rotation, look at the screen, and when you see a peak reading on the Dynamic graph, PRESS and RELEASE a red button to mark the peak. 32. Ask the patient to return to the center. When you see the readings drop on the screen count 1-1000, 2-1000 and PRESS and RELEASE one red button to mark the valley in neutral. 33. Repeat 31 and 32 above until there are three left rotations. 34. When three rotations have been stored, and/or you are at the end of the screen, press and hold a RED button on either FlexVision to continue on to the next screen. 35. Repeat 30-32 for right rotation. 36. Now, have the patient lay on their back making certain to move the DynaVision out of the way (you may lay it next to the patient). From behind the patient, place one FlexVision on the forehead, with the label facing you (towards the top of their head). Place the other FlexVision on the table also in the same plane as the one on the forehead. 37. Repeat steps 31through 33 to gather Range of Motion data along with Dynamic sEMG. 38. At the last screen press REVIEW to store the data and review. 39. To print the results, click the PRINT button in the upper left of the screen, and select your options, click OK, select your printer and print.

23-000-LBL01 Rev E

Page 49 of 60

Chapter

4
MyoVision Use, Maintenance and Troubleshooting
This section will cover basic procedural tips for ensuring proper use and maintenance of data. For up-to-date information visit: www.MyoVision.com under Support and/or Training. Support MyoVision is known worldwide for having the best technical support available. If you have any questions, please do the following: Send e-mail to: support@MyoVision.com with any questions you have. E-mail is normally responded to within 6-24 hours. Call our Telephone support @ 1-800-969-6961, option 3. Support hours are 9:005:00 pm M-F, PST. Our unique remote modem support is available whenever technical issues cannot be resolved easily over the phone.

Basic Printing Functions: Print an open patient exam report 1. User must have an exam open to select. The type of report and print options presented to the user depends on the type of protocol that was used when the exam was performed. 2. Click File, Print Exam 3. Modify report settings or click OK. Select Report of Findings, Static Graphic 23-000-LBL01 Rev E Page 50 of 60

and Narrative Report (not available in Non-Measuring). Backup of Database It is recommended that the MyoVision 3G WireFree database be backed up every day. This ensures that your data is recoverable should there be a system failure. 1. Click the Backup button on the MyoVision toolbar. 2. Where it says Save In, select a location to save to. You can use a USB flash drive or R/W CD. 3. Click Save. 4. If successful, you will get a message that your database was backed up successfully. Restore the Database 1. Insert the CD or USB flash drive that has the backed up database into the computer you want to restore to. 2. In the MyoVision software, click File > Restore Exams. 3. Browse the backup disk and double- click on the *.bu2 file you want to use. Change the QuickScreen Default Protocol 1. Click Setup > Settings > QuickScreen. 2. Select the desired protocol from the drop down list. Running 64-bit version of Windows If you are running the 64 bit version of Windows you will need to download the 64 bit version of SQL Server Express 2005. Go to http://www.MyoVision.com/HowtosandFAQs.html to download and run the SQLExpress file. Basic EMG Setup Issues
For Static or Dynamic SEMG

Verify that hardware is setup and functioning properly: Virtually 99% of the problems are simple to diagnose, and even simpler to fix. Before proceeding, be certain to verify that all hardware is setup properly. Surface EMG is sensitive to the effects of electrical interference caused by fans, motors and cell phones. Review each question in the table below to determine proper setup prior to continuing. Hardware Setup Issues 1. Are you using a grounded AC adapter? This is the plug which connects your computer to the surge protector or wall outlet. If you have only a two prong plug, the computer is not grounded properly and can cause electrical interference. NOTE: This is NOT the plug from the surge protector to the wall outlet, but the plug which connects directly to your computer. 23-000-LBL01 Rev E Page 51 of 60

If you do not have a grounded AC adapter, you need to purchase one for your computer. You can purchase a grounded AC adapter from www.IGO.COM. Call them at 888-205-0064 and ask for the 'JUICE' or ICE adapter. They offer a grounded adapter for most computers.

2. Are you plugged into a grounded (three prong) AC outlet? It is recommended that you utilize a surge protector, and plug that directly into a grounded wall outlet (one which has three prongs). Note that many older homes or offices do not have grounded AC outlets. 3. Are you in an older office where you question whether it may or may not have grounded outlets? Have you had other problems with electrical devices? Some older offices may have 3 prong AC wall outlets, but the 3rd prong (ground) may not be connected properly. To test for a functional ground, purchase the Radio Shack part # 22-141. Its available at the website and is approximately $6.00 USD. http://www.radioshack.com/product.asp?catalog%5Fname=CTLG&product%5Fid=2 2-141

Simply plug it into the wall outlet, and it can verify whether the outlet is properly grounded. If it is NOT properly grounded, contact an electrician to resolve the issue. It is a very important safety hazard, and when repaired will prevent damage to other electrical devices in addition to providing greater safety. 4. Are your electrodes in good shape? If electrodes are in poor shape, readings will typically be very high and erratic, as there is less silver to conduct electricity generated by the muscles as they contract. Bad electrodes will also require significantly more QuickScan liquid to compensate for their lack of conductivity.

23-000-LBL01 Rev E

Page 52 of 60

The way you can tell is by the color. If they are a dark black, they are considered in good condition. Electrodes which are light, shiny or have many spots are worn, and need to be replaced. You can order them by contacting MyoVision at 800-969-6961. 5. Is there a bluish liquid on the white plastic where the static electrodes are inserted? Your scanners should look like the image to the right: Clean with no bluish liquid between the electrodes. If so, the bluish liquid may have been built up over time from use, or if you are placing the electrodes inside the jar instead on top of the jar, the QuickScan liquid splashes onto the device, creating higher readings by shorting out the probes. No damage is caused by this, but readings will be higher. Remove the electrodes from the probe by twisting and removing. Clean the plastic thoroughly with an alcohol soaked paper towel. Reinsert the electrodes. Always place the QuickScan pads on the lid of the jar. Never place the instrument inside the jar itself. Troubleshooting Dynamic sEMG
Confirm hardware is set up properly before proceeding.

Tips For Performing Dynamic Lumbar Flexions 1. Make certain to have the patient perform three flexions in a row before taking data. 2. Show them how to perform the flexion, asking them to drop their head to reduce probability that lordosis is not reduced in flexion. 3. Make sure they stay in the flexed position UNTIL you tell them to stand up. This allows you time to mark their flexed position with the spacebar properly. 4. Press the Spacebar to begin the test, THEN tell them to begin the flexion. Do not press the spacebar AFTER telling them to begin the flexion. 5. Always mark flexion studies in "valleys" only both at full flexion, and neutral. 6. After pressing the spacebar, have them bend forward, and do NOT press the spacebar when they are fully flexed, but instead watch the screen for the readings to level off creating the "valley" and then press the spacebar (usually 2 seconds after they have reached full flexion. After pressing spacebar, immediately ask them to return to neutral. 7. At neutral, again do NOT press the spacebar but instead look at the screen to watch for the readings to level off in the "valley" and then press the spacebar (usually 2 seconds after they have reached neutral). 8. Make sure that timing-wise you have them moving fast enough to perform three flexions in the 30 second time window allowed for the three flexions. This makes the timing between all patients consistent. 23-000-LBL01 Rev E Page 53 of 60

What if the test results do not look consistent or I do not finish three flexions in the 30 seconds? 1. If the patient can perform three flexions without pain, you simply are learning how to do the test properly. Press the CLEAR button to the far right, and redo the test. 2. If the patient is in severe pain, and cannot complete three tests then put this in your chart notes, and the data should show that the readings correlate with this pain, meaning that most likely there will be very high and erratic readings. 3. Oftentimes there is a "training effect" meaning that the patient needs to do the test once before becoming accustomed to it. Once they have gotten used to it, the second 30 second test is clear and consistent. Should I perform tests other than the dynamic lumbar flexion test? What about lateral flexions and rotations? 1. Performing the Lumbar Lateral Flexion and Rotation is advantageous in that the more data you have, the more information you have on your patient. 2. With lateral flexions and rotations, you are following the same procedure as above, but marking at "peaks" in full rotation or lateral flexion (the highest points reached) and then "valleys" in neutral. 3. Press the spacebar and start by having the patient perform a movement to the left (left lateral flexion, or left rotation). The software is set up so that you do lateral flexions first. 4. There is no need to wait the 2 seconds for the readings to stabilize when at the end of their range of motion. Simply hit the spacebar when at full Left Lateral Flexion for example. When they return to neutral, allow the readings to settle (typically 2 seconds) before pressing the spacebar. You can fit two lateral flexions on each screen, perhaps three. 5. To move from the lateral flexion screen to the Rotation screen, click the NEXT button to the far right on the screen. Troubleshooting Range of Motion It is very important to use the button on the probe properly. Never press and hold the button after the software has "beeped" to inform you that the button press has been accepted. If the button is held for too long, it will cause a reset of the device. You will simply have to restart the test if this occurs. How To Use Red Button On Probe To Navigate Software The button probe on the MyoVision Range of Motion Device was designed to allow you to perform all Range of Motion measures without having using the keyboard at all. 23-000-LBL01 Rev E Page 54 of 60

1. Once you have finished calibrating the device, click on "Flexion" to begin the test. The following instructions apply to all tests (flexion, extension etc.). 2. Hold Main probe at approximately T1, and the smaller Aux probe along the occipital with label to left or right. 3. While holding the probes between thumb and middle finger, rest the pinky and fourth finger on the body along the side of the probe to stabilize the probe on the body. 4. Make certain that the label on both probes is facing the same direction (left or right) depending on whether you are right or left handed. 5. With the patient in a neutral posture, press and hold the red button until the computer "beeps". This beep indicates that the "Zero" position has been recorded for the test you are performing. 6. Have the patient perform the test required (flexion in this example) and stop at the end range of motion. 7. Press and hold the red button until the computer "beeps" indicating that the reading has been taken. 8. To perform multiple readings (for AMA guides), have the patient return to the neutral posture, then WITHOUT pressing the button have the patient move to the end of range of motion again. Press the red button until the computer "beeps" and immediately release the button. The beep indicates the value for range of motion was stored. Again, follow the same process again taking the last of the three readings (five if required). 9. To take data when it is not important to meet AMA guides, you can simply press and release the button three times (with a second or two break between beeps) to store three readings with the body at the end range of motion. TRICK: After completing a range of motion, to move to the next without touching the keyboard at all, simply press the button and release as soon as the computer "beeps" and you see the screen for the next range of motion. By using the button, you can move from motion to motion without ever touching the computer keyboard. What to do when the readings appear "Invalid"? 1. The variability between trials of each range of motion is measured, and compared with allowed values. If you receive the message and voice prompt "VALID TEST", simply press and release the button to continue to the next motion.

23-000-LBL01 Rev E

Page 55 of 60

2. If you receive the message and voice prompt "INVALID TEST" this means that there was too much variability between trials, and you can either accept this, or redo the test. 3. To redo the test, click REDO at the bottom right of the screen. Make certain to hold the probes against the body in a stable fashion (use your pinky and fourth finger against the body to stabilize the probe to get better reproducibility. Once you have completed the test, you can review or print the report by clicking the REVIEW button.

23-000-LBL01 Rev E

Page 56 of 60

Index

Backup of Database, 51 Basic EMG Setup Issues, 51 Basic Printing Functions, 50 Calibration of ThermoVision / Thermoglide Unit, 18 Change the QuickScreen Default Protocol, 51 CONTRAINDICATIONS, 6 DISPOSABLES, 5 Dynamic Surface EMG Procedures: Properly preparing the patient, 38 DynaVision, 3, 4 FlexVision, 4 Hardware Setup Issues, 51 INDICATIONS FOR USE, 6 Measurement Information, 10

Offices With More Than One 3G WireFree System, 18 POWER CABLES, 4 Range of Motion, 3 Restore the Database, 51 Running 64-bit version of Windows, 51 ScanVision, 4 Software Features, 36 Static Surface EMG Procedures: Properly preparing the patient, 30 Support, 50 ThermoGlide, 3 Thermography, 3 Troubleshooting Dynamic sEMG, 53 Troubleshooting Range of Motion, 54 Warnings and Precautions, 7

23-000-LBL01 Rev E

Page 57 of 60

WARRANTY REPAIRS APPLY ONLY IN THE U.S.A. All repairs for units sold outside the US may require shipment to the US for repair. One Year Limited Warranty (Computer Equipment Warranted By Computer Manufacturer Directly) Precision Biometrics, Inc. (PBI-USA) warrants that products distributed by PBI-USA WORLDWIDE. that fail to function properly under normal use due to a manufacturing defect when installed and operated according to the Owners Manual /Training Videos/Help File included with the software with the unit will be repaired or replaced with a unit of comparable value, at the option of PBI-USA, without charge to you for parts or actual repair work. Parts supplied under this warranty may be new or rebuilt at the option of PBI-USA. THIS LIMITED WARRANTY APPLIES TO THE ORIGINAL OWNER OF THIS PBI-USA PRODUCT DURING THE WARRANTY PERIOD, PROVIDED THE PRODUCT WAS PURCHASED FROM AN AUTHORIEZED PBI-USA DISTRIBUTIOR/DEALER IN THE U.S.A. YOU WILL BE REQUIRED TO PROVIDE A SALES RECEIPT OR OTHER VALID PROOF OF PURCHASE SHOWING THE DATE OF ORIGINAL PURCHASE. IN THE EVENT SERVICE IS REQUIRED, THE PRODUCT MUST BE DELIVERED WITHIN THE WARRANTY PERIOD, TRANSPORTATION PREPAID, ONLY FROM WITHIN THE U.S. A. AS EXPLAINED IN THIS DOUCMENT, YOU WILL BE RESPONSIBLE FOR REOMVAL AND INSTALLATION OF THE PRODCUCT, PBI-USA WILL PAY TO RETURN THE PRODUCT TO YOU WITHIN THE USA, 3-DAY AIR. IF FASTER SHIPPING REQUIRED, IT WILL BE AT THE EXPENSE OF THE OWNER, AND BE PREPAID VIA CREDIT CARD OR CHECK. ANY DUTY OR TAXES REQUIRED BY FOREIGN COUNTRIES WHEN RETURN SHIPPING REPAIRS ARE THE RESPONSIBILITY OF THE PURCHASER IN FULL. Shorter limited warranty periods may apply to some models. Please refer to any limited warranty document enclosed with the product for a definitive statement of the warranty period. The warranty period begins the date of shipment from PBI. WHAT IS NOT COVERED: (a) IF THIS PRODUCT WAS PURCHASED FROM AN UNAUTHORIZED DISTRIBUTOR, THERE ARE NO WARRANTIES, EXPRESSED OR IMPLIED. THERE IS NO EXPRESSED OR IMPLIED WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND THIS PRODUCT IS SOLD STRICTLY AS IS AND WITH ALL FAULTS". (b) PBI-USA SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL AND/OR INCIDENTAL DAMAGES. THIS WARRANTY DOES NOT APPLY IF THE PRODUCT HAS BEEN SUBJECTED TO POWER IN EXCESS OF ITS PUBLISHED POWER RATING. THIS WARRANTY DOES NOT COVER DAMAGE DUE TO ABUSE, FIRE, NEGLECT OR ANY ACT OF GOD. (c) THIS WARRANTY DOES NOT COVER ANY DAMAGE TO DATA STORED BY USER, AS IT IS THE RESPONSIBILITY OF THE USER TO BACK UP ALL DATA, ANY DAMAGE TO THE PRODUCT RESULTING FROM ALTERATIONS, MODIFICATIONS NOT AUTHORIZED IN WRITING BY PBI-USA, ACCIDENT, MISUSE OR ABUSE, (d) DAMAGE DUE TO LIGHTNING OR TO POWER SURGES, SUBSEQUENT DAMAGE FROM LEAKING, DAMAGE FROM INOPERATIVE BATTERIES, OR THE USE OF BATTERIES NOT CONFORMING TO THOSE SPECIFIED IN THE OWNERS MANUAL. (e) THIS WARRANTY DOES NOT COVER THE COST OF PARTS OR LABOR WHICH WOULD BE OTHERWISE PROVIDED WITHOUT CHARGE UNDER THIS WARRANTY OBTAINED FROM ANY SOURCE OTHER THAN A PBI-USA AUTHORIZED SERVICE COMPANY OR OTHER DESIGNATED LOCATION. THIS WARRANTY DOES NOT COVER DEFECTS OR DAMAGE CAUSED BY THE USE OF UNAUTHORIZED PARTS OR LABOR OR FROM IMPROPER MAINTENANCE. (f) ALTERED, DEFACED, OR REMOVED SERIAL NUMBERS VOID THIS ENTIRE WARRANTY. (g) DAMAGES DUE TO DEFECTIVE OR LEAKING BATTERIES. NO OTHER WARRANTIES: PBI-USA LIMITS ITS OBLIGATIONS UNDER ANY IMPLIED WARRANTIES INCLUDING,

ONE YEAR LIMITED WARRANTY

23-000-LBL01 Rev E

Page 58 of 60

BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, TO A PERIOD NOT TO EXCEED THE WARRANTY PERIOD. NO WARRANTIES SHALL APPLY AFTER THE WARRANTY PERIOD. SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS AND SOME STATES DO NOT ALLOW THE EXCLUSIONS OR LIMITATIONS OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY HAVE OTHER RIGHTS WHICH MAY VARY FROM STATE TO STATE. Should your product require service: A RAN (Return Authorization Number) must be issued before shipping device(s) to PBI. To receive warranty service you need to present your sales receipt. If shipping the unit you will need to package it carefully and send it, transportation prepaid by a traceable, insured method, to an Authorized Service Company (In most cases PBI Main Office, San Carlos, CA). Package the product using adequate padding material to prevent damage in transit. The original container is ideal for this purpose. Include your name, address and telephone number and email address where you can be reached during business hours along with a description of the problem. On all complaints and concerns in the U.S.A. call Customer Support at 1-800-969-6961. In Canada call: Royal Cross at 1-800-461-0100. Following our response to any initial request to Customer Support, should a dispute arise between you and PBI-USA, PBIUSA makes available its Complaint Resolution Program to resolve the dispute. The Complaint Resolution Program is available to you without charge. You are required to use the Complaint Resolution Program before you exercise any rights under, or seek any remedies, created by Title I of the Magnuson-Moss Warranty-Federal Trade Commission Improvement Act, 15 U.S.C. 2301 et seq. To use the Complaint Resolution Program call 1-800-969-6961 and explain to the customer service representative the problem you are experiencing, and steps you have taken. SHIPPING ADDRESS FOR ALL USA SALES OR WORLDWIDE (EXCEPT FOR CANADA): PRECISION BIOMETRICS, INC. (USA) TECHNICAL SUPPORT DIVISION 981-A INDUSTRIAL ROAD SAN CARLOS, CALIFORNIA 94070 WWW.MYOVISION.COM, email: SUPPORT@MYOVISION.COM, Phone: 650-508-2600- select technical support Note: D3-PhysioMonitor, D5-FlexVision, D6-DynaVision, D7-ScanVision and ThermoGlide (TT) carry a non-transferable 1 year limited warranty. RECORD THE FOLLOWING: Serial #: D3 ____________ D5 _____________ D6 _____________ D7 ______________ Thermoglide (TT) _____________ Other _____________ Purchase Date: ____________________________ Purchased From: ____________________________ Keep this information and sales receipt. DISPUTE RESOLUTION: To have the product repaired during the warranty period, have the name of the authorized Distributor/Dealer from whom the PBI-USA product was purchased. After the complaint has been explained to the representative, a resolution number will be issued. Within 40 days of receiving your complaint, PBI-USA will investigate the dispute and will either: (1) respond to your complaint in writing informing you what action PBI-USA will take, and in what time period, to resolve the dispute; or (2) respond to your complaint in writing informing you why it will not take any action.

23-000-LBL01 Rev E

Page 59 of 60

MyoVision Return Policy

The Primary Goal of PBI/MyoVision is to have every customer satisfied with their order. We will pay the return shipping costs if the product is defective upon receipt by original owner or the return is a result of a manufacture defect. Although we make every effort to satisfy our customers, if the item is returned for any other reason, the customer is responsible for the shipping charges and a restocking fee of 15 percent. Please read and follow these simple instructions regarding returns: Original owners qualify for refunds under this policy. You must request a return for refund within 30 days of the original delivery date. Each return must have an RMA number, a Return Merchandise Authorization. RMA numbers are issued by your sales representative. Please write down your RMA number on the outside of the box that contains the merchandise you want to return. RMA numbers are valid for 15 days. When returning the product, we strongly recommend the use of a carrier that can track packages. You are also responsible for insuring the return item for its full value. Precision Biometrics, Inc. will not be responsible for any shipping loss nor will it reimburse any customer for the shipping cost of a returned product. The customer must inform Precision Biometrics, Inc of any order discrepancy within 7 days of the delivery date. Physical damage to the returned product will void the products warranty and the RMA policy. All returns must be returned in as new condition and have the original packaging, accessories, and user manual. Please note that not all items are covered by our return policy. We cannot accept returns of certain items for a refund, including: Computer equipment (desktops, laptops, monitors, printers) Customized literature: PB-500/PB-1000 Patient Recall Postcards Perishable supplies such as: PB-30/PB31 QuickScan Pads PB-10/PB-11/PB-212 Static electrodes PB-20 Signa Crme PB-50/PB-53 Dynamic electrodes Customers are responsible for shipping any returned products to Precision Biometrics, Inc. and agree to pay all shipping charges as well as accept all risk of loss for the product being returned. The customer agrees that all returned products will be 100% complete, in re-salable condition and will include the original packaging material, manuals, and other accessories provided by the manufacturer. Precision Biometrics, Inc. will reject the entire return or may choose to impose additional charges against the customer for replacement of any missing parts or components. The same policy applies if the product has scratches, dents, or excessive wear. Please allow 5-7 business days to process your returns. IMPORTANT NOTE for M8000 USERS!!! THE VISIONPORT2 IS MANDATORY FOR USE WITH THE LATEST VERSION OF MYOVISION SOFTWARE WHEN RUNNING THE M8000 SYSTEM. RETURN OF THE VISIONPORT2 WILL VOID REGISTRATION OF SOFTWARE UPGRADES AND TECHNICAL SUPPORT.

o o o

23-000-LBL01 Rev E

Page 60 of 60