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Intelect® Advanced sEMG and sEMG + Stim Module

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

PRODUCT DESCRIPTION

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SAFETY PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

PRECAUTIONARY DEFINITIONS

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CAUTIONS

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WARNINGS

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DANGERS

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EMG INDICATIONS

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sEMG + STIM INDICATIONS, CONTRAINDICATIONS

AND ADVERSE EFFECTS

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Indications- sEMG + Stim using VMS™, Symmetrical Biphasic (TENS), . . . .

Asymmetrical Biphasic (TENS) or Russian waveforms

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Contraindications

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Additional

Precautions

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Adverse

Eﬀ

ects

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NOMENCLATURE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10

sEMG and sEMG + STIM STANDARD ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . 8

SYMBOL DEFINITIONS

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System Hardware Symbols

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SystemSoftware

Symbols

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Operator

Remote

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Battery

Module

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Channel

3/4ElectrothrapyModule

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TERMINOLOGY DEFINITIONS

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SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-13

EMG AND sEMG + STIM MODULE SPECIFICATIONS

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WAVEFORM SPECIFICATIONS

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TENS- Asymmetrical Biphasic

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TENS- Symmetrical Biphasic

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VMS

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High Voltage Pulsed Current (HVPC)

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INSTALLATION & REMOVAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-19

GENERAL INFORMATION

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sEMG

Module

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Therapy

System

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THERAPY SYSTEM PREPARATION

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Disconnect System Mains

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Disconnect Leads and Accessories

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Remove Therapy System from Cart

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Remove

Module

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Remove

Breakout

Tabs

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INSTALLING

EMG MODULE

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Position sEMG Module

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Secure sEMG Module

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Install and Reinstall Additional Module

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Install Rear Access Panel

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Install Cables and Accessories

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Apply Mains Power

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REMOVING

EMG MODULE

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Prepare

System

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Remove sEMG Module

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sEMG Plug Kit

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PATIENT PREPARATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-24

EMG AND

EMG+STIM PATIENT PREPARATION

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Electrode

Placement

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Dura-Stick™ II Electrodes

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Install sEMG Lead Wires to System

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Install Dura-Stick™ II Electrodes

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Select

Modality

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Select Body Area

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View Electrode Placement Graphic

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View Electrode Placement Text

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Prepare

Treatment

Area

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Electrode

Placement

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Intra-Vaginal

Probe

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OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25-43

EMG THERAPY SET UP

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General

Information

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Optional Patient Data Management System (PDMS)

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sEMG

Screen

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TABLE OF CONTENTS

Содержание Intelect Advanced 2771

Страница 1: ...User Manual Operation Installation Instructions for 2771 sEMG and sEMG Stim Module Therapy System DJO is an ISO 13485 Certified Company ...

Страница 2: ...ALLATION REMOVAL 14 19 GENERAL INFORMATION 14 sEMG Module 14 Therapy System 14 THERAPY SYSTEM PREPARATION 15 Disconnect System Mains 15 Disconnect Leads and Accessories 15 Remove Therapy System from Cart 15 Remove Module 15 Remove Breakout Tabs 16 INSTALLING SEMG MODULE 17 Position sEMG Module 17 Secure sEMG Module 17 Install and Reinstall Additional Module 17 Install Rear Access Panel 17 Install ...

Страница 3: ...35 Edit Stim 36 Select Target Option 36 Setting Max Target 36 Setting Avg Target 37 Setting Manual Target 38 Set Volume 38 Set Auto Feature 39 Start sEMG Therapy Session 39 Stopping Stim 40 Stopping Therapy Session 40 SET UP OF NEW SEMG DATA CARD 41 General Information 41 Insert New sEMG Data Card 42 Prepare System and Patient 42 Set Up sEMG Therapy Session 42 Enter Patient ID 42 Begin Save 43 End...

Страница 4: ...of this equipment should read understand and follow the information contained in this and the Therapy System User Manual for each mode of treatment available as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the application of electrotherapy ultrasound sEMG Surface Electromyography sEMG Stim Surface Electromyography w...

Страница 5: ...age Text with a Dangerous Voltage indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient in certain treatment configurations of TENS waveforms NOTE Throughout this manual NOTE may be found These Notes are helpful information to aid in the particular area or function being described PRECAUTIONARY DEFINITIONS Caution Warning Dangerous Volt...

Страница 6: ...ly with new before any treatment is applied The Intelect Advanced Therapy System is not designed to prevent the ingress of water or liquids Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with ...

Страница 7: ...own Stimulation should not be applied over the anterior neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing WARNINGS Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmia Stimulation should n...

Страница 8: ...ximity to any shortwave diathermy microwave diathermy therapeutic ultrasound diathermy or laser diathermy anywhere on their body Energy from diathermy shortwave microwave ultrasound and laser can be transferred through the implanted neurostimulation system can cause tissue damage and can result in severe injury or death Injury damage or death can occur during diathermy therapy even if the implante...

Страница 9: ...tivation timing of muscles for Retraining of muscle activation Coordination of muscle activation An indication of the force produced by muscle for control and maintenance of muscle contractions Relaxation muscle training Muscle re education SAFETY PRECAUTIONS Indications Surface EMG ...

Страница 10: ...on may occur at the site of electrode placement following long term application The effectiveness of TENS waveforms is highly dependent upon patient selection by a person qualified in the management of pain patients Indications sEMG Stim using VMS Symmetrical Biphasic TENS Asymmetrical Biphasic TENS or Russian waveforms Contraindications This device should not be used for symptomatic local pain re...

Страница 11: ...el 1 3 sEMG Electrical Stimulation Lead Wires for Channel 2 4 Dura Stick II 3 2 cm 1 25 Self Adhesive disposable Electrodes 3 packs of 4 5 User Manual CD ROM 6 Intra Vaginal Probe not illustrated 1 2 3 4 5 Handle clean and dispose of components and accessories that have come in contact with bodily fluids according to National Local and Facility rules regulations and procedures ...

Страница 12: ...ENSITY DECREASE INTENSITY PAUSE TREATMENT MANUAL STIMULATION CHANNEL 3 LEAD WIRES CHANNEL 4 LEAD WIRES MICROCURRENT PROBE CHARGE LEVEL BATTERY CHARGING CHANNEL 3 4 OPERATOR REMOTE CONTROL OPTIONAL PATIENT INTERRUPT SWITCH CONTRAST CONTROL NOT FUNCTIONAL ON COLOR SYSTEMS NOMENCLATURE System Hardware Symbols System Software Symbols Optional Module and Accessory Symbols Operator Remote Battery Module...

Страница 13: ...ERMINOLOGY NOMENCLATURE Back Button Previous Page Button UP and DOWN Arrows Electrotherapy System sEMG Module Abbreviation for the Surface Electromyography modality sEMG sEMG Stim The button used in some modalities and functions that will take the user back one page when reading multiple pages of text Controls used in various modality parameter screens to navigate or change a value up or down with...

Страница 14: ...ht 3 cm 1 187 Input Impedance 1 000 000 ohm Input Sensitivity 1 0 µV RMS Frequency Range 15 Hz 300 Hz with CMMR of 120 dB CMMR at 50 60 Hz 180 dB Weight 105 g 3 8 oz Product Type Internally Powered Intelect Advanced Therapy System Electrical Class Class I Electrical Type Type BF For Continuous Operation Regulatory Compliance UL IEC EN 60601 1 IEC EN 60601 1 2 IEC 60601 2 10 ...

Страница 15: ...metrical Biphasic waveform has a short pulse duration and is capable of strong stimulation of nerve fibers in the skin and in muscle This waveform is often used in portable muscle stimulation units and some TENS devices Because of its short pulse duration the patient typically tolerates the current well even at relatively high intensities Output Mode Electrodes Output Intensity 0 80 mA Phase Durat...

Страница 16: ...es Available on Channels 1 2 3 4 Option CC Constant Current CV Constant Voltage WAVEFORM SPECIFICATIONS continued SPECIFICATIONS High Voltage Pulsed Current HVPC VMS is a symmetrical biphasic waveform with a 100 µsec interphase interval Because the pulse is relatively short the waveform has a low skin load making it suitable for applications requiring high intensities such as in muscle strengtheni...

Страница 17: ...the Therapy System it will be necessary to remove the Battery Laser or Channel 3 4 Electrotherapy Module Refer to the respective Module User Manual for Instructions Installing the sEMG Module on the System will make the sEMG and sEMG Stim modalities available for Channels 1 2 If installed on the Optional Channel 3 4 Electrotherapy Module sEMG and sEMG Stim modalities will be available on Channels ...

Страница 18: ... the Therapy System Cart User Manual DISCONNECT ALL ACCESSORIES Remove Therapy System from Cart Place the System upside down on a smooth surface Place a soft clean fabric or cushion under the System Display Lens to prevent damage Remove Module Remove Channel 3 4 Electrotherapy Battery or Laser Module if equipped Refer to the respective User Manual for the Module being removed WARNING Disconnect th...

Страница 19: ...ver carefully remove the four sEMG Breakout Tabs on the system bottom NOTE Twist the screwdriver to break tabs free If installing on the Channel 3 4 Electrotherapy Module remove tabs from the Module in the same manner BREAKOUT TABS CAUTION Be careful not to cause any damage to the PC Board Contacts that will be exposed once the Breakout Tabs are removed ...

Страница 20: ...odule until it snaps and is locked into position NOTE If installing the System to a Therapy System Cart refer to the Therapy System Cart User Manual for proper instructions If desired install a Channel 3 4 Battery or Laser Module to the System refer to the respective module User Manual for installation instructions prior the following procedures Install and Reinstall Additional Module Install Rear...

Страница 21: ...follow the instructions on the Screen CONNECT ALL CABLES AND ACCESSORIES Apply Mains Power Verify that the Module installed is the Module displayed in the message BEFORE pressing the START Button If it is not DONOTpress the START Button Turn the System OFF and back ON If the problem continues call the selling dealer or DJO Technical Support immediately DONOTUSETHESYSTEM until all necessary repairs...

Страница 22: ...m and the Channel 3 4 Electrotherapy Module when the sEMG Module has been removed The sEMG Plug Kit must be installed when an sEMG Module has been removed for service related problems and the Therapy System will be put back into service without the sEMG module The sEMG Plug Kit is installed and removed in the same fashion as an sEMG Module Refer to page 17 for installation instructions sEMG Plug K...

Страница 23: ...rated during treatment Electrodes in contact with each other could result in improper stimulation or skin burns Output current density is related to electrode size Improper application may result in patient injury If any question arises as to the proper electrode size consult a licensed practitioner prior to therapy session Powered muscle stimulators should be used only with the leads and electrod...

Страница 24: ...inued Remove the Front Access Cover from the Therapy System and remove the existing Lead Wires Connect the sEMG Lead wires to the channel s desired for use with the sEMG or sEMG Stim modality CONNECT SEMG LEAD WIRES Replace the Front Access Cover NOTE Two Channels may be used for sEMG Therapy at the same time If four electrotherapy channels are available a maximum of only two may be used at a time...

Страница 25: ...ntil the area desired is highlighted UP ARROW BUTTON DOWN ARROW BUTTON NOTE The Page Up and Page Down buttons allow navigation either at the top or bottom of the available selections Press the Accept and Return Arrow button to view the specific electrode placement graphic ACCEPT AND RETURN ARROW BUTTON NOTE As illustrated the two Black electrodes represent Active electrodes and the one White elect...

Страница 26: ... Press the Back button to return to the Select Body Area screen Press the Back button a second time to return to the Treatment Review screen NEXT PAGE BUTTON PREV PAGE BUTTON Prepare Treatment Area Examine the skin for any wounds Thoroughly clean the treatment area by scrubbing the skin with medical grade alcohol NOTE Thorough and proper cleaning of the treatment area to remove any topical medicat...

Страница 27: ...mmends using only Dura Stick II electrodes to obtain the most accurate sEMG feedback Follow the electrode manufacturer instructions Trimming or cutting electrodes may interfere with the reception of sEMG data and may affect the delivery of electrical stimulation in the sEMG Stim Modality Keep stim electrodes separated during sEMG Stim treatment Electrodes in contact with each other could result in...

Страница 28: ...ching those goals in a specific muscle or muscle group Within this section general setup procedures of the various parameters of sEMG are explained Also setup and use of the optional sEMG Data Card for recording sEMG Data is demonstrated General Information The sEMG data can be recorded onto the optional sEMG Data Card and viewed in graph form via the optional Patient Data Management System connec...

Страница 29: ... Allows selection of Constant Pulsed or Dynamic audio types Constant is the Default Unit Setting 6 Volume Set volume level to Low Medium High or Off Medium is the Default Unit Setting 1 3 5 2 4 6 OPERATION The Intelect Advanced sEMG screen affords access to all of the sEMG parameters and functions The area surrounding the screen has 10 parameter modification buttons However only six are used for t...

Страница 30: ...MG Modality SEMG BUTTON Press the sEMG Description Text button to view text explaining the rationale of sEMG Therapy View sEMG Description Text SEMG DESCRIPTION TEXT BUTTON Press the Next Page button to view additional text Press the Prev Page button to review previous page Press the Back button to return to the Treatment Review screen BACK BUTTON NEXT PAGE BUTTON PREV PAGE BUTTON NOTE Refer to pa...

Страница 31: ...re 3 4 or 3 4 CHANNEL BUTTON Set Alarm Set the alarm trigger in relation to the target by pressing the Alarm button until the desired selection is displayed in the Alarm icon The available selections are Above Alarm sounds when a muscle contraction surpasses the target Target Alarm sounds when a muscle contraction reaches the target Below Alarm sounds when a muscle contraction is below the target ...

Страница 32: ...tions in 10 seconds Avg Average of maximums achieved in 15 seconds of muscle contractions Manual Set Target manually Press the Target button until the prescribed target option is displayed in the Target icon Select Target Option TARGET BUTTON Setting Max Target Make certain Target Max is displayed in the Target icon Press the Capture Target button Have the patient begin contracting the muscle and ...

Страница 33: ...egin contracting and releasing the muscle Press the Begin Capture button The patient should contract and release the muscle as many times as possible during the preset 15 second contraction period NOTE During the preset 15 second contraction period the Therapy System captures and retains the average maximum level of all contractions that the patient performed CAPTURE TARGET BUTTON BEGIN CAPTURE BU...

Страница 34: ... AND RETURN ARROW BUTTON UP ARROW BUTTON Set Volume Press Volume button until the desired volume level is displayed in the Volume icon The available volume levels are Low Medium High and Off VOLUME BUTTON NOTE If Volume is Off no alarm will be heard when contraction reaches the target setting Make certain Target Manual is displayed in the Target icon Press the Adjust Target button Setting Manual T...

Страница 35: ... sEMG Data Card cannot be used to save session parameters Press the Stop Button The Completed Treatment Review Screen will display Stopping sEMG Therapy Session OPERATION SEMG THERAPY SET UP continued Start sEMG Therapy Session Have patient perform contractions as prescribed As the patient contracts the muscle the Vertical Scale for the channel being used will begin to fill from bottom to top When...

Страница 36: ...t is given a short rest period and then repeats the muscle contraction attempting to reach the target to again trigger the electrical stimulation This is repeated throughout the therapy session Session parameters can be stored on a Patient Data Card The Patient Data Card can be used with the optional Patient Data Management System for adding session notes and printing reports Several sessions can ...

Страница 37: ...ss the Edit button on the Treatment Review screen to edit sEMG Stim parameters as prescribed EDIT BUTTON Select Channel Press the Channel button until the prescribed channel is displayed in the icon Therapy System Available selections are 1 or 2 Channel 3 4 Electrotherapy Module Available selections are 3 or 4 CHANNEL BUTTON NOTE The sEMG Stim will not function as a multi channel modality It is de...

Страница 38: ...lection is displayed in the Alarm icon The available selections are Above Alarm sounds when a muscle contraction surpasses the target Target Alarm sounds when a muscle contraction reaches the target Below Alarm sounds when a muscle contraction is below the target NOTE If Volume is Off no alarm will be heard Set Audio Type Audio sets the type of sound heard when the muscle contraction reaches the A...

Страница 39: ... seconds Avg Average of maximums achieved in 15 seconds of muscle contractions Manual Set Target manually Press the Target button until the prescribed target option is displayed in the Target icon Select Target Option Setting Max Target Make certain Target Max is displayed in the Target icon Press the Capture Target button Have the patient begin contracting the muscle and press the Begin Capture b...

Страница 40: ...ontracting and releasing the muscle Press the Begin Capture button The patient should contract and release the muscle as many times as possible during the preset 15 second contraction period NOTE During the preset 15 second contraction period the Therapy System captures and retains the average maximum level of all contractions that the patient performed CAPTURE TARGET BUTTON BEGIN CAPTURE BUTTON D...

Страница 41: ...EPT AND RETURN ARROW BUTTON UP ARROW BUTTON Make certain Target Manual is displayed in the Target icon Press the Adjust Target button Setting Manual Target ADJUST TARGET BUTTON Set Volume Press Volume button until the desired volume level is displayed in the Volume icon The available volume levels are Low Medium High and Off VOLUME BUTTON NOTE If Volume is Off no alarm will be heard when contracti...

Страница 42: ...t the short period of Stim After all parameters for sEMG and Stim have been completed press the Start sEMG Stim button START SEMG STIM BUTTON NOTE The Stim Intensity may be adjusted only during the Stim portion of the sEMG Stim therapy session Set Auto Feature The sEMG Stim Auto feature is designed to work in conjunction with the Target settings When On the Auto feature will automatically adjust t...

Страница 43: ...om an sEMG Stim therapy session cannot be recorded to an sEMG Data Card or Patient Data Card Press the Stop button The Completed Treatment Review screen will display Stopping Therapy Session Stim may be restarted at any time during the session by pressing the Start sEMG Stim button NOTE With Stim Off the sEMG portion of the session may continue After Stim is complete the screen will change and the...

Страница 44: ...eports adding session notes and adding other sEMG specific information to the sEMG data through a Windows PC The Therapy System recording device allows recording only of the sEMG Data No sEMG Data may be recorded from the PC and saved to the sEMG Data Card for use in the Therapy System However the sEMG session parameters may be saved to a Patient Data Card refer to the Therapy System User Manual a...

Страница 45: ...SERT NEW SEMG DATA CARD Set up the patient s prescribed sEMG therapy session Refer to pages 25 through 32 of this manual for sEMG modality set up Press the Setup sEMG Card button Set Up sEMG Therapy Session Prepare System and Patient Prepare Therapy System and patient Refer to pages 20 through 24 SETUP SEMG CARD BUTTON Select the row of alpha or numeric characters by pushing the button beside the ...

Страница 46: ...ll display in the top of the screen and the cursor will advance to the next position To move back a character press the Left Arrow button To discard entire entry press the back Button Repeat this procedure until the desired Patient ID is entered After Patient ID is entered press the Save button CHARACTER DISPLAYED ACCEPT AND RETURN ARROW BUTTON LEFT ARROW BUTTON To delete a character press the Lef...

Страница 47: ...ct with treatment area B Replace Lead Wires and Electrodes 101 Warning Shorted Lead Wires A Check Electrodes and Lead Wires Make certain Lead Wires are not damaged and are properly connected to the system Make certain Lead Wires are properly connected to the Electrodes and that electrodes are not damaged and are making proper contact with treatment area B Replace Lead Wires and Electrodes 102 Warn...

Страница 48: ...ists connect a known good Ultrasound Applicator If problem continues contact dealer or DJO for service 113 Warning Attempting to perform Ultrasound treatment with no Applicator connected to the system A Connect the desired Ultrasound Applicator to the system B If Ultrasound Applicator is connected reset system by turning power switch Off and On C If problem persists connect a known good Ultrasound...

Страница 49: ...herapy System User Manual for instructions 124 Warning Patient Treatment Data already saved A Cannot save same data again on Patient Data Card B Use a new Patient Data Card to resave data C Erase Patient Data Card and resave treatment data 125 Warning Multimedia Card MMC not in system port A Properly insert the MMC card into the system port B Insert a known good MMC Card If problem continues conta...

Страница 50: ...t no Laser Applicator is plugged in A Connect desired Laser Applicator to the system B If Applicator is connected reset Therapy System by turning main power switch Off and On C Connect a known good Laser Applicator D If problem continues send Laser Module to factory for service 133 Warning Laser Applicator became unplugged while performing a laser treatment A Connect desired Laser Applicator to th...

Страница 51: ... Warning Battery Module software upgrade warning Upgrade Battery software to latest version Contact dealer or DJO for latest software upgrade and instructions 142 Warning A Laser Protocol was selected but no Laser Module is installed on system Install Laser Module to Therapy System Refer to Laser User Manual for installation instructions 143 Warning A Laser Protocol was selected but no Laser Appli...

Страница 52: ... save data to Patient Data Card In the event that an Error message or Warning appears beginning with a 2 or 3 immediately stop all use of the system and contact the dealer or DJO for service Errors and Warnings in these categories indicate an internal problem with the system that must be tested by DJO or a Field Service Technician certified by DJO before any further operation or use of the system ...

Страница 53: ...ary MMC Card 1 27465 Patient Data Card 5 2771 sEMG Module Factory Installed 1 27567 sEMG Accessory Kit Includes the Following 1 27321 sEMG Channel 1 A Lead Wire 1 27322 sEMG Channel 2 B Lead Wire 1 77725 Intravaginal Probe 1 42061 3 2 cm 1 25 Round Disposable Electrode Pack 4 per pack 3 27455 User Manual CD ROM 1 Color Series Optional Accessories Order No Description 2770 Two Channel Electrotherap...

Страница 54: ...een wet inside until inspected and tested by a Service Technician Certified by DJO Do not allow liquids to enter the ventilation holes in the optional modules This could permanently damage the modules CARING FOR THE THERAPY SYSTEM SERVICE Should the unit require service warranty or repair please contact the selling dealer or your local DJO customer service Ultrasound Applicators require annual cal...

Страница 55: ...rvice technician Any malfunction or failure in the Product caused by product misuse including but not limited to the failure to provide reasonable and required maintenance or any use that is inconsistent with the Product User s Manual DJO LLC is not responsible for injury or damage resulting from modifications or service performed by non authorized DJO LLC service personnel COMPANY SHALL NOT BE LI...

Страница 56: ...nglish DJO is an ISO 13485 Certified Company DJO France SAS Centre Europeen de Fret 3 rue de Bethar 64990 Mouguerre France T 33 0 5 59 52 86 90 F 33 0 5 59 52 86 91 djoglobal eu fr_FR 2011 DJO LLC All rights reserved ...

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