Noraxon U.S.A., Inc.

Inline FootSwitch

Inline FootSwitch User Manual

P-3008 Rev G (Nov 2013)

Noraxon U.S.A., Inc.

Inline FootSwitch

For questions, concerns or additional assistance please contact Noraxon or its Authorized Representative as specified below.

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Manufacturer: Noraxon U.S.A. Inc. 15770 North Greenway-Hayden Loop, Suite 100 Scottsdale, AZ 85260 Tel: (480) 443-3413 Fax: (480) 443-4327 Email: [email protected] Support Email: [email protected] Web Site: www.noraxon.com

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Authorized European Representative: Advena Ltd. Pure Offices, Plato Close, Warwick CV34 6WE, UK Telephone +44(0)1926 800153 +44(0) 845 094 3307 Email: [email protected] Website: http://www.advenamedical.com Skype: advenamedical

C 0473 Notified Body: Clearance to market this product in the European Community has been certified by Notified Body #0473, AMTAC of the UK.

© Copyright, 2013, Noraxon U.S.A. Inc.

No part of this document may be copied, photographed, reproduced, translated, or reduced to any electronic medium or machine-readable form without the prior written consent of Noraxon U.S.A. Inc. Noraxon is a registered trademark of Noraxon U.S.A. Inc. All rights reserved. All other company and product names contained herein may be trademarks or registered trademarks of their respective companies and are sole property of their respected owners.

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Table of Contents

Section 1: Introduction   Brief Description ...................................................................................................... 1 Intended Use .......................................................................................................... 1 Contraindications ...................................................................................................... 1

Section 2: Definitions  Graphic Symbols and Meanings............................................................................... 2 Glossary of Terms ................................................................................................... 2

Section 3: Identification  Model Designation ................................................................................................... 3 Product Versions and Configurations ...................................................................... 3

Section 4: General Warnings and Cautions  Risks and Benefits .................................................................................................... 4 Safety Information Summary ................................................................................... 5

Section 5: Getting Started  Quick Start Guides .................................................................................................. 5

Section 6: Preparing the Product for Use (Setup Instructions)  Unpacking and Component Identification ................................................................ 5 Component Inputs, Outputs and Indicators .............................................................. 6 Component Interconnections ................................................................................... 6 Device Communication (Driver) Software Installation ............................................. 6 Companion Software Installation ............................................................................. 7 Companion Software Configuration ........................................................................ 7

Section 7: Pre‐use Check‐out  Normal Appearance of Signals .................................................................................12 Setting the Sensitivity ..............................................................................................12 Attaching the EMG Sensor to a Patient or Subject .................................................12 Sensor Placement ...................................................................................................13

Section 8: Operating Instructions  Safety Information Summary ....................................................................................14 Normal Functions with Interface in PC .....................................................................14 Exceptional Functions/Situations (error messages) .................................................14

Section 9: Accessories and Optional Modules  Accessories ..............................................................................................................15 Options .....................................................................................................................15

Section 10: Cleaning  Safety Precautions When Cleaning ..........................................................................16 Cleaning by Users ....................................................................................................16

Section 11: Maintenance  Safety Precautions When Performing Maintenance.................................................17 Maintenance by Users ..............................................................................................17 Maintenance by Qualified Individuals .......................................................................17

Section 12: Trouble‐shooting, Fault Diagnosis  Troubleshooting Chart ..............................................................................................17 Website Link to FAQ .................................................................................................17

Section 13: Service and Repair  Availability of Circuit Diagrams and Component Lists .............................................18 Warranty Information ................................................................................................18 Submitting Service Requests ...................................................................................18

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Returning Equipment ................................................................................................18

Section 14: List of Spare Parts and Consumables  Consumable Items (electrodes and sensor elements) .............................................19 Replaceable Items (fuses, batteries, lead sets) ......................................................19

Section 15: Taking Product Out of Operation  Disposal of Equipment and Batteries .......................................................................19

Section 16: Specifications of the Product  Expected Useful Lifetime ..........................................................................................20 Dimensions and Weight ...........................................................................................20 Performance Characteristics ...................................................................................20 Energy Consumption, Condition of Use ..................................................................20 Environmental Conditions for Storage and Transport .............................................20 IP (Ingress Protection) Rating ..................................................................................20

Section 17: Technical Information  Block Diagram .........................................................................................................21 Theory of Operation .................................................................................................21

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Section 1: Introduction Brief Description  The Inline foot contact sensor lead consists of 2 FSR (force sensitive resistor) switch sensors. They can be mounted on the heel and the toe or metatarsal region. It is designed for quick and easy use in clinical gait analysis. Each lead has a built-in sensitivity switch which allows for the adjustment of the switch threshold for in-shoe measurements. The inline foot switch leads have universal functionality covering easy and quick to use setups for clinical gait screening, running and jump testing. If damage occurs due to heavy impact or shear forces (running/jumping), broken sensors are easily replaced. The special connector allows easy replacement, but keeps the sensor from falling out during testing.

Intended Use  The Inline FootSwitch sensors are intended to measure and quantify forces during physical activity either separately or in combination with other kinematic or kinetic signals using a Noraxon EMG system. This information can be used to affect muscle training and reeducation. Intended Users Researchers or individuals trained in physical medicine, physical therapy or ergonomics Subject Populations – Medical Individuals with cerebral palsy, physical injuries, post-surgical or post-stroke conditions Subject Populations – Non medical Athletes, workers at their worksite, subjects in new product trials Common Applications Gait analysis; tracking over time the outcome of surgical, therapeutic or orthotic interventions; identification of ergonomic stress factors in the workplace or new product designs

Contraindications  There are no contraindications for users of Noraxon’s Inline FootSwitches.

 

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Sec ction 2: Definitions Grap phic Symbo ols and Meaaning    The fo ollowing international icons s and symbols are found o on the Inline F Footswtich se ensor and in this user manual. Their T meaning g is described d below.

   

                                                                               

  Approval to m A market this prooduct in the EEuropean Com mmunity wass  ce ertified by No otified Body ##0473 AMTAC C of the UK.      Read material  R in the Instru ction Manuall wherever th his symbol  appears. 

 

  Id dentifies the m manufacture r of the devicce. 

                                                                 

  Id dentifies the sserial numbe r of the devicce.   

 

 

  Additional info A ormation ava ilable in a sep parate docum ment 

  Glossary of Terrms    Channel – Any one e of the meas surable signals designated as Channel 1 through (up p to) Channel 16 in the Noraxon systems. Probe e – A generic term for any sensor. Senso or Type – Reffers to different models of inline sensorss. Each senso or model mea asures a give en type of o physical pa arameter. Diffe erent Inline Sensor S Types can be comb bined in the sa ame network.. The most m common n Inline Senso or Type is EMG. Exampless of other type es include Acccelerometers, Gonio ometers and Force F sensors s.

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Section 3: Identification Model Designation 

 

 

Model 300 Inline FootSwitch

Product Versions and Configurations    The model 300 Inline Footswitch sensor can work in conjunction with any of the Noraxon wired EMG systems. Model 042 MyoTrace 400 Model 210 MyoSystem 1400A Model 211 MyoSystem 1400L Model 290 TeleMyo 2400T G2 For additional equipment details refer to Section 9 of this manual. As the Noraxon Systems require software to perform its function, the equipment is offered in combination with the following computer program packages. Model 133 MyoResearch-XP Master Edition Model 430-433 myoMUSCLE

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Section 4: General Warnings and Cautions Risks and Benefits  There is no identified risk of physical harm or injury with use of the Inline FootSwitch sensor. The benefit provided by use of the device is the provision of objective measures to assess the severity of pathological human movement conditions and gauge any subsequent improvement offered by therapy, training, prosthetic alterations or ergonomic design changes.

Safety Information Summary        Warnings     

Do not immerse the Inline FootSwitch in any water or liquid The Inline FootSwitch produces results that are informative, not diagnostic. Qualified individuals must interpret the results

 

Attention    

The operator must be familiar with typical characteristics of the signals acquired by the Inline FootSwitch and be able to detect anomalies that could interfere with proper interpretation.

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Section 5: Getting Started Quick Start Guides  Please see the hardware manual for the appropriate Noraxon EMG system.

Section 6: Preparing the Product for Use (Set-up Instructions) Unpacking and Component Identification       

  Inline FootSwitch Lead Set (Part #300)     

 

                  

                       

  Inline FootSwitch FSR Sensor Assembly (2 or 4  sensors) (Part #FSA1)       

 

  Foot Insole (Optional) (Part #085F)   

 

Additional contents not illustrated  Inline FootSwitch User Manual (part #3008) This document    If additional accessories have been included please see Section 9, Accessories for component  identification. 

 

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Component Inputs, Outputs and Indicators    1 Sensitivity Dial 

  Sensitivity Dial – Allows the user to set how  sensitive the sensors are to pressure 

  Component Interconnections  Step 1 

  Insert the FSR Sensor Assembly  into the Inline Foot Switch Lead  set.   

Step 2   

  Connect the 4‐pin connector to an  available lead input connector on  the Noraxon EMG system   

Note: The Inline FootSwitch connects directly to Noraxon’s inline EMG systems via their  available analog input jacks/connectors. 

Device Communication (Driver) Software Installation   Please see the hardware manual for the appropriate EMG system.

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Companion Software Installation   The Inline FootSwitch sensor is compatible with several different software programs. Identify the companion software that accompanied the equipment (MyoResearch or MR3 myoMUSCLE) and follow the instructions given in the hardware manual.

MyoResearch XP Installation  1. 2. 3. 4. 5. 6.

Insert the MyoResearch XP Software CD into the PC. A menu will automatically pop up. Click on “Install MRXP” and follow the Wizard’s instructions. When the Wizard requests a password, enter the password printed on your CD case. After installing MRXP exit (close) the MRXP software. Click on “Install Patch” and follow the Wizard’s instructions.

The installed companion software must be activated before unrestricted use is possible. 1. 2. 3. 4. 5.

Open MRXP. A dialog box will indicate how many more times MRXP can be opened. Click on “Enter Activation Code”. Call or email Noraxon Support with the provided Activation Key. Please include the following: Your name, Company/Organization Name, Serial Number on EMG system and the Activation Key. 6. Noraxon Support will email or respond by phone with the Activation Code 7. Enter the provided Activation Code to remove any restrictions on use.

MR3 Installation  1. Before you start the MR3 software please connect all devices you plan to use with the software to your PC. 2. Insert the installation USB card or use the MR3 download file and start the installation with Noraxon.mr.3.0.x.exe (x is the latest version release number). 3. Follow the steps in the Installation Wizard menu and click Finish to close the Installation Wizard routine. A new Icon will appear on your desk top: 4. Double click

on the icon to start the MR3 software.

Companion Software Configuration  Before the Inline Footswitch can be used with the Noraxon EMG system can be used, the companion software must be configured to recognize the different components that make up the system. Refer to the EMG system’s hardware manual for instructions for the particular program (MyoResearch or MR3 myoMUSCLE) supplied with the Noraxon EMG system. For specific settings for the Inline FootSwitch see below:

 

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MyoResearch XP Configuration  Step 1 Enter the Hardware Setup screen and setup the Noraxon EMG system in accordance with its provided hardware manual.

Step 2 When done in the Hardware setup menu, return to the Measurement screen. In the Muscle Device Maps, select the Noraxon G2 Sensors tab.

Step 3a Highlight the channel number that will use the FootSwtich and click on the check box in the lower right corner of the Inline FootSwitch icon box

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Step 3b OR Click on the check box next to the channel the Inline Footswitch is plugged into. The channel will default to EMG, but this can be changed by double clicking the Type of sensor and scrolling to find Inline FootSwitch.

Step 4 Continue with the measurement setup as described in the EMG system’s hardware manual.

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MR3 Configuration  Step 1 Enter the Hardware Setup screen and setup the Noraxon EMG system in accordance with its provided hardware manual.

Step 2 Once back in the Home screen, choose to create a new or edit an existing configuration.

Step 3 In the measurement setup screen, insert the EMG system into the Devices in your configuration box.

Step 4 Once the EMG system device is inserted, the muscle map will appear to the left, and the EMG channels and sensors will appear below. Highlight the first channel being used for the Inline FootSwitch.

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Step 5a Select the Noraxon G2 Sensors tab where the muscle map is displayed. Click on the check box in the lower right corner of the Foot Switch/Sole icon box.

Step 5b OR Click on the check box next to the channel the FootSwitch is plugged into. The channel will default to EMG, but this can be changed by double clicking in the Sensor column of the channel and scrolling to find G2 Foot Switch.

Step 6 Continue with the measurement setup as described in the EMG system’s hardware manual.

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Section 7: Pre-Use Check-Out Normal Appearance of Signals  Before recording begins, a preview of the signal(s) is given. Be sure a signal is generated and performing as expected.

Setting the Sensitivity  The sensitivity dial allows the user to set how sensitive the sensors are to pressure. Various factors can influence the behavior of the sensor. Two main factors are the subject’s weight (adult male vs. small child) and the tightness of shoes, if worn. The sensitivity is set by turning the dial on the Inline FootSwitch lead set. (Clockwise makes it more sensitive or easier to detect a pressure change.) Have the subject stand with his/her feet flat on the ground and then lift one leg up. Set the sensitivity so that when the subject has his/her foot off the ground, none of the sensors are registering that they are closed. This control does not work with insole type sensors. (Their sensitivity is fixed.) When using insole sensors, place this control in the far counterclockwise position.

Attaching to Patient or Subject  To secure the Inline Footswitch, use the double-sided tape and/or a flexible bandage that sticks to itself, e.g. Coban. If insoles are being used, simply slip the insoles into the shoe of the user. It is important the correct size is used in order to acquire accurate signals without causing damage to the insoles.

 

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Sensor Placement  Tape the sensors to the foot as shown below; either side of the sensor may be taped to the foot. Sensor Placement for 2 Sensors

Sensor Placement for 4 Sensors

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Section 8: Operating Instructions Safety Information Summary  Strictly follow all safety practices given in section 4 of this manual. The most critical ones are repeated here.

    Warnings     

Do not immerse the Inline FootSwitch sensor in any water or liquid The Inline Footswitch sensor produces results that are informative, not diagnostic. Qualified individuals must interpret the results

Normal Functions with Interface to a PC  When used with the companion software the Inline FootSwitch displays and records signal similar to the one below (only one foot was measured):

Consult the user manual for the companion software for descriptions of the setup, playback and analysis of the data acquired by the EMG system.

Exceptional Functions/Situations (error messages)  Please see the appropriate EMG system’s hardware manual for possible error messages.

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Sec ction 9: Access sories an nd Optio onal Mo odules Acce essories    Part N No.    ES2 

Image e 

Description n    Elastic strapp for adheringg the sensor tto the user   

  As new accessoriess may be available after th he time of pri nting, pleasee check Noraxxon’s website  at thiss link for the latest offerings.      http:///noraxon.com m/products/ 

Interrface to Otther Device es    Part N No.    230 

Image e 

Descrription    TeleM Myo 2400T G11 

…  More…    

  Myo 2400T G22  TeleM  

 

 

  290      210 

 

  MyoSSystem 1400A A 

 

  MyoSSystem 1400LL   

 

  MyoTTrace 400 

 

  Senso or Power Suppply with an A A/D board   

 

 

 

  211   

  042 

 

 

 

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Section 10: Cleaning Safety Precautions When Cleaning 

WARNING Only use a damp cloth with mild soap and water or isopropyl alcohol to clean the Inline FootSwitch sensors. Do not immerse Inline FootSwitches in any water or liquid. When cleaning or disinfection, the FootSwitch should be disconnected from all instrumentation and power sources.

Cleaning by Users  For sanitary purposes, it is advisable to clean the Inline FootSwitch sensors on a regular basis. The FootSwitch sensors can be cleaned with a cloth slightly dampened with a solution of mild soap and water or isopropyl alcohol. The Inline FootSwitch is not constructed to withstand repeated application of any disinfectant solution. Likewise, the FootSwitches are not warranted against exposure to any of the conventional forms of sterilization. Users wishing to utilize this equipment in a sterile environment, such as an operating theater, should consult Noraxon for other options

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Section 11: Maintenance Safety Precautions When Performing Maintenance  No precautions required.

Maintenance by Users  No regular maintenance by the user is required.

Maintenance by Qualified Individuals  The following activities should only be undertaken by PC support (IT) personnel, equipment technicians or those with suitable training.

Companion Software Updates      

Perform a backup of the data folders to a separate drive as a precaution. Click on the Patch/Update link provided in the email or as given on the Noraxon website http://noraxon.com/software-downloads Download the Patch/Update file. To install the Patch/Update, click “Run” on the dialog box. No password is required.

 

Section 12: Trouble Shooting, Fault Diagnosis Troubleshooting Chart  Please see the EMG device hardware manual for trouble shooting.

Website Link to FAQ  Answers to common questions can be found at Noraxon’s Frequently Asked Questions (FAQ) website page at this link: http://noraxon.com/faq Other educational material is available at this link: http://noraxon.com/educational-materials

 

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Section 13: Service and Repair Availability of Circuit Diagrams and Component Lists  Noraxon will make available on request circuit schematics, component parts lists and calibration instructions to assist qualified technical personnel in the service and maintenance of the Inline FootSwitches.

Warranty Information    Noraxon equipment including optional items is guaranteed to be free from defects in material and workmanship for 1 year from the date of purchase. The warrant period begins on the date of product shipment from Scottsdale, Arizona. Warranty coverage does not apply to damage incurred through accident, alteration, abuse or failure to follow instructions contained in this document. An optional extended warranty is available. Please contact Noraxon USA for further details.

Submitting Service Requests    A Service Request can be submitted using the online form available at this link: http://noraxon.com/service-request Provide all information requested by the form including a detailed description of the problem being experienced and your telephone number or e-mail address.

Returning Equipment  Be sure to obtain an RMA Number (return material authorization) before returning any equipment. Completing the online service request form will assign an RMA Number. Otherwise contact Noraxon USA. Send the equipment postage prepaid and insured to the address below. Include the RMA Number on the shipment label. Mark the package “Goods to be repaired – Made in USA” to avoid unnecessary customs charges. (Beware listing a Customs or Insurance value of $5,000.00 USD or more will result in a delay at United States Customs.) Noraxon USA 15770 N. Greenway-Hayden Loop Suite 100 Scottsdale, AZ 85260, USA If you are shipping from outside the USA please use UPS, FedEx, DHL, or EMS (US Postal Service) and not a freight-forwarder. Using a freight-forwarder incurs additional brokerage fees. If a package is shipped to Noraxon via a carrier other than the ones listed above, it may be refused.

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Norax xon U.S.A., In nc.

Sec ction 14 4: Spare e Parts and a Con nsumabl les Conssumable Ite ems    Part  No.    542C 

Image 

Description n 

 

  Double sideed tape for atttaching DTS ssensors, 504  per packagee   

          

 

 

Replaceable Ite ems    Part  No.    FSA1      085F   

Image 

Description n 

 

  bly  Inline FootSSwitch FSR Seensor Assemb

 

  Foot Insole

                      

  ES2         

 

 

  Elastic strapp, 36 inches lo ong (cut to leength) for  securing DTTS sensors  

Sec ction 15 5: Taking g Produ uct out o of Oper ration Disposal of Equ uipment an nd Batterie es  Pleas se check with the governing g authorities in i your locatio on before disp posing of the Inline FootS Switch and its contents.

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Section 16: Specifications of the Product Expected Useful Lifetime  The Inline FootSwitch sensor has a usable life of seven years.

Dimensions and Weight    

Sensor Diameter: 0.75in (18.5mm) Detachable Sensor Lead Length: 12in (31cm) Inline Cable Length: 42 in (~1m)

Performance Characteristics     

FSR Sensor Response Time: ~2 ms Analog Output Signal Range: 0V to +5V Sensitivity Adjustment: .015 to 1.2 kg/cm2 Output Levels: 2 (foot on/off) o No Pressure: 0V o Any Sensor activated: 5V

Energy Consumption, Condition of Use  

Sensor is powered by the attached EMG system

Environmental Conditions for Storage and Transport    

Ambient Temperature: -40C to +70C Relative Humidity: 10% to 100% Atmospheric Pressure: 500hPa to 1060hPa

IP (Ingress Protection) Rating    The Inline FootSwitch device enclosures have a low ingress protection rating (IP20). The Inline FootSwitches are not waterproof. Care must be taken to avoid exposure to all liquids. Heavy perspiration may present problems if the FootSwitch connections are secured to bare skin with an over wrap of tape or elastic belting. In such cases it is advisable to first add adsorptive material or cloth over the InlineFootSwitch connections before covering the sensor with tape or elastic bands.

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Section 17: Technical Information Block Diagram  Model 300 Inline FootSwitch  Coming Soon…

Theory of Operation   The Inline foot contact sensor lead consists of 2 FSR (force sensitive resistor) switch sensors. They can be mounted on the heel and the toe or metatarsal region. It is designed for quick and easy use in clinical gait analysis. Each lead has a built-in sensitivity switch which allows for the adjustment of the switch threshold for in-shoe measurements. The switch sensor has plug-in functionality for Noraxon cable (1400 series), telemetry (TeleMyo 2400 series) and the MyoTrace 400 systems. The FSR sensor consists of a thin circular film pad that is easy to attach. During walking, each side creates a ground contact on/off signal. Within this scheme, any ground contact increases the signal to high level and swing phase drops the signal back to zero. This established switch scheme can be used to trigger unilateral and bilateral gait phases. The Inline FootSwitch detects when the foot is touching the surface, but it does not differentiate which part of the foot is touching the surface. All sensors (two or four) send the same signal, either on (5 volts) or off (0 volts). Each sensor sends a signal to the output device and displays it on the software (such as MR3 or MyoResearch XP).

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