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Intelect® Mobile Stim

SAFETy PrECAuTiONS

iNdiCATiONS, CONTrAiNdiCATiONS, ANd AdvErSE EFFECTS

indications for VMs, russian, TENs, High Voltage Pulsed

Current (HVPC), 2 Pole iFC, 4 Pole iFC and Premodulated

Waveforms

•

Relaxation of muscle spasms

•

Prevention or retardation of disuse atrophy

•

Increase local blood circulation

•

Muscle re-education

•

Maintaining or increasing range of motion

additional indications for Microcurrent, 2 Pole iFC, 4 Pole iFC,

Premodulated, VMs™, and TENs Waveforms

•

Symptomatic relief of management of chronic, intractable pain

•

Post-traumatic acute pain

•

Post-surgical acute pain

indications for galvanic Continuous Mode

•

Relaxation of muscle spasm

Contraindications

•

This device should not be used for symptomatic local pain

relief unless etiology is established or unless a pain syndrome

has been diagnosed.

•

This device should not be used when cancerous lesions are

present in the treatment area.

•

This device should not be used when open wounds are

present in the treatment area.

•

Other contraindications are patients suspected of carrying serious

infectious disease and or disease where it is advisable, for general

medical purposes, to suppress heat or fevers.

•

Electrode placements must be avoided that apply current to the

carotid sinus region (anterior neck) or transcereberally (through

the head).

•

Safety has not been established for the use of therapeutic

electrical stimulation during pregnancy.

•

Powered muscle stimulators should not be used on patients with

cardiac demand pacemakers.

•

There should not be any use of TENS waveforms on patients with

cardiac demand pacemakers.

additional Precautions

•

Caution should be used for patients with suspected or diagnosed

heart problems.

•

Caution should be used for patients with suspected or diagnosed

epilepsy.

•

Caution should be used in the presence of the following: When

there is a tendency to hemorrhage following acute trauma or

fracture; Following recent surgical procedures when muscle

contraction may disrupt the healing process; Over a menstruating

or pregnant uterus; Over areas of the skin which lack normal

sensation.

Содержание Intelect Mobile Stim 2777

Страница 1: ...Moving Rehabilitation Forward Electromagnetic Compatibility EMC Tables User Manual Operation Installation Instructionsfor 2777 Two Channel Mobile Stimulation Unit DJO is an ISO 13485 Certified Company ...

Страница 2: ...11 Common Terms 11 Nomenclature 15 SPECIFICATIONS 19 Unit Specifications 19 Description of device markings 20 Waveform Specifications 21 Setup 28 MOUNTING THE UNIT ON the WALL 28 installing the battery pack 32 cHARGING the battery pack 34 uSING THE BATTERY PACK 34 Patient Preparation 35 Electrotherapy Patient Preparation 35 Electrode Placement 35 DURA STICK Electrodes 36 Reusable Carbon Electrodes...

Страница 3: ...ing Factory Protocols 52 Changing Languages 54 Restoring Factory Settings 55 Viewing Unit Version Information 56 tROUBLESHOOTING 58 Error codes 58 ACCESSORIES 60 Standard Accessories 60 Optional Accessories 60 Mains Power Cords 60 Maintenance 61 Maintaining THE UNIT 61 Cleaning the Unit 61 Factory Service 61 Warranty Repair Out of Warranty Repair 61 WARRANTY 62 ...

Страница 4: ...information regarding the application of electrotherapy Product Description The Intelect Mobile Stim designed and manufactured by DJO offers a new dimension in clinical electrotherapy made possible by software design and digital signal processing Effectiveness of this treatment is dependent upon correct use If treatment times are exceeded the therapy may not result in positive clinical outcomes St...

Страница 5: ... possible safety infractions that will potentially cause serious injury and equipment damage 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 NMES waveforms NOTE Throughout this manual NOTE may be found These Notes are helpful information to aid in the partic...

Страница 6: ...nates electrotherapy power output when the timer reaches zero The Intelect battery pack is designed for use only with Chattanooga Intelect Mobile Stim Combo Laser and Ultrasound systems Inspect cables and connectors before each use The Intelect Mobile Stim is not designed to prevent the ingress of water or liquids Ingress of water or liquids could cause malfunction of internal components of the sy...

Страница 7: ...ver This may cause unit damage malfunction electrical shock fire or personal injury There are no user serviceable parts inside the unit If a malfunction occurs discontinue use immediately and consult the dealer for repair service Failure to use and maintain the Intelect Mobile Stim and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty Use of ...

Страница 8: ... serve as a protective mechanism Be sure to read all instructions for operation before treating a patient Warnings The user must keep the device out of the reach of children Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when TENS stimulation is in use Powered muscle stimulators should be used only with the leads and electrodes recommended for use by t...

Страница 9: ...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 Warnings continued Use only accessories that are specially designed for this device Do not use accessories manufactured by other companies on this device DJO LLC is not responsible for any consequence resulting from using products manufactured by ...

Страница 10: ...nit was constructed to operate only on the electrical voltage specified on the Voltage Rating and Serial Number Plate Contact your DJO dealer if the unit is not properly rated Dangers Equipment not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed...

Страница 11: ...dividual cell temperature and cause cell rupture or leakage Never dispose of the battery pack in fire Never short circuit the battery pack The battery pack may explode ignite leak or get hot causing serious personal injury Dispose of NiMH batteries according to national state and local codes and regulations Dangers continued ...

Страница 12: ... when open wounds are present in the treatment area Other contraindications are patients suspected of carrying serious infectious disease and or disease where it is advisable for general medical purposes to suppress heat or fevers Electrode placements must be avoided that apply current to the carotid sinus region anterior neck or transcereberally through the head Safety has not been established fo...

Страница 13: ...nce of the prescribing practitioner Powered muscle stimulators should be used only with the Lead Wires and electrodes recommended for use by the manufacturer With TENS waveforms isolated cases of skin irritation 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 man...

Страница 14: ...nt HVPC Microcurrent VMS TENS Russian Träbert Monophasic and Diadynamic Fifteen user defined memory positions Lightweight design Battery powered option Common Terms Accommodation condition where nerves lose their ability sensitivity to respond to electrotherapy Amplitude Modulation Ampl Mod Amplitude Modulation is an increase and decrease in intensity during treatment For example at an 80 amplitud...

Страница 15: ...delivering an electric current that flows at the same amplitude regardless of changes in tissue impedance over time Constant voltage is a stimulator capable of delivering a source of voltage at the same amplitude regardless of changes in tissue impedance over time Most modern electrotherapy units are of the constant current type because they provide a consistent or stable level of current amplitud...

Страница 16: ... red that connect to electrodes Medium Frequency Current These are the currents used by the Traditional Interferential IFC 4 Pole Interferential Premodulated and Russian waveforms that is higher than 1000 Hz but lower than 10000 Hz Operating Channels Operating Channels are the paths by which the electrotherapy is distributed from the unit to the patient The unit provides two channels of electrical...

Страница 17: ...c Rectangular and Monophasic Triangular Vector A vector is a geometrically descriptive feature used to increase the effective therapeutic current at the crossing point of Traditional Interferential IFC 4 Pole Vector Position The available vector positions are 0 to 90 degrees Vector Scan Measured in percentages vector scans are the rhythmic changes of the position of vector The available vector sca...

Страница 18: ...TURE 15 Power On Off LCD TIME Clinical Resources Back STOP Down Arrow PAUSE Accessory Panel Parameter Display Enter START INTENSITY Up Arrow LCD Intensity Contrast Dial Channel 1 Lead Wire Connection Channel 2 Lead Wire Connection ...

Страница 19: ...ources Select this button to access the following functions Retrieving User Protocols Restoring Factory Settings Restoring Factory Protocols Changing Languages Viewing Unit Information Use the Up and Down Arrow buttons to navigate through the available options TIME Press the Up or Down arrow buttons to set total treatment time of therapy Back Use this button to return to the previous window STOP S...

Страница 20: ...ART Select Start to begin a treatment session Parameter Display Enter Select this button to display the parameters of the waveform during treatment Also this button is used to accept the highlighted selection INTENSITY Use the up or down arrow to increase or decrease output power dosage Up Arrow When the window displays a list of options press the Up Arrow button to scroll up the list Battery Indi...

Страница 21: ...splays when the unit is connected to mains power and the battery pack is charging NOTE During battery operation if the unit is left on but is not active for more than five minutes it will power off to conserve battery power To restore power press the Power On Off button ...

Страница 22: ... CLASS I Electrical Type TYPE BF Battery Type Nickel Metal Hydride NiMH 1 2 V x 20 size AA Operating Environment Temperature Between 15 C and 40 C 59 F and 104 F Relative Humidity 30 60 Atmospheric Pressure 950 1050 h Pa Complies with UL IEC EN 60601 1 IEC EN 60601 1 2 IEC 60601 2 10 NOTE All waveforms except High Voltage Pulsed Current HVPC have been designed with a 200 mA peak current limit All ...

Страница 23: ...UMENTS Type BF Equipment EU Directive on Waste Electrical and Electronic Equipment WEEE ensures that product is appropriately disposed of or recycled at the end of its life The markings on the unit are assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility One or more of the following markings may appear on the device ...

Страница 24: ... Treatment Time 1 60 min Waveform Specifications 2 Pole IFC 4 Pole IFC Interferential current is a medium frequency waveform Current is distributed through two channels four electrodes The currents cross each other in the body at the area requiring treatment The two currents interfere with each other at this crossing point resulting in a modulation of the intensity the current intensity increases ...

Страница 25: ... CycleTime Continuous 5 5 4 12 10 10 10 20 10 30 and 10 50 Treatment Time 1 60 min Galvanic Current is a direct current flowing in one direction only The current can be continuous or interrupted Output Mode Electrodes Output Intensity 0 80 mA Polarity Positive or Negative Polarity Reversal On or Off With Polarity Reversal On Polarity will change halfway through the treatment CycleTime Continuous 5...

Страница 26: ...stant Voltage Stimulus delivered by the TENS waveforms of this device in certain configurations will deliver a charge of 25 micro coulombs µC or greater per pulse and may be sufficient to cause electrocution Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia TENS Asymmetrical Biphasic The Symmetrical Biphasic waveform has a short pulse d...

Страница 27: ... pps 1 120 pps 1 10 pps Frequency 10 120 pps Cycle Time 5 5 4 12 10 10 10 20 10 30 10 50 Continuous Treatment Time 1 60 Min Waveform Specifications continued High Voltage Pulsed Current HVPC Microcurrent is a monophasic waveform of very low intensity The literature reports beneficial effects of this waveform in the treatment of wounds The physiological working mechanism of this effect is as yet no...

Страница 28: ...ting in Reciprocal and Co Contract modes CycleTime Continuous 5 5 4 12 10 10 10 20 10 30 10 50 Frequency 1 200 pps Ramp 0 5 sec 1 sec 2 sec 5 sec Treatment Time 1 60 min CC Constant Current CV Constant Voltage VMSTM Russian Current is a sinusoidal waveform delivered in bursts or series of pulses This method was claimed by its author Kots to produce maximal muscle strengthening effects without sign...

Страница 29: ...terval 5 5000 ms Treatment Time 1 60 min MONOPHASIC Monophasic Triangular Pulsed Waveform Specifications continued It is a monophasic waveform with a phase duration of 2 ms and a pause of 5 ms resulting in a frequency of approximately 143 Hz Output Mode Electrodes Output Intensity 0 80 mA Polarity Reversal On or Off With Polarity Reversal On Polarity will change halfway through the treatment Treat...

Страница 30: ... of 100 Hz phase duration of 10 ms followed immediately by another identical phase of 10 ms CP Modulé en Courtes Périodes 1 second of MF followed abruptly by 1 second of DF LP Modulé en Longues Périodes Rhythmical fluctuation between 2 MF currents CP iso Courtes Periodes Isodynamic A combination of MF and DF waveforms Diadynamic Waveforms The Monophasic Rectangular Pulsed waveform is an interrupte...

Страница 31: ...bile Stim can be operated while the unit is resting on a flat surface or mounted on a wall To mount the unit on a wall do the following 1 Remove the repositional base from the back of the unit 2 Using the repositional base as a guide mark the 4 wall holes with a pencil or pen ...

Страница 32: ...UNTING THE UNIT ON the WALL continued 3 Using an appropriate size drill bit drill four holes you marked in the previous step 4 Press 4 appropriately sized drywall anchors into the wall so that the drywall anchor is flush with the wall ...

Страница 33: ... ON the WALL continued 5 Screw four 8 pan head sheet metal screws 2 54 cm or 1 inch into the wall anchors Make sure you leave 0 635 cm 1 4 of an inch between the wall and the head of the screw 6 Replace the repositional base on the back of the unit ...

Страница 34: ...im SETUP 31 MOUNTING THE UNIT ON the WALL continued 7 Line up the screw heads with the holes on the repositional base and slide the unit down slightly until the screw heads are securely fastened to the repositional base ...

Страница 35: ...d an optional battery pack The pack contains 20 Nickel Metal Hydride NiMH drycell batteries To install the battery pack in the Intelect Mobile Stim do the following 1 Locate the battery access door at the bottom of the unit and loosen the screw with a flat head screwdriver 2 Remove the battery access door and retain it ...

Страница 36: ...m SETUP 33 installing the battery pack continued 3 Connect the battery pack cable to the unit s battery connector in the bottom of the battery recess 4 Put the battery pack into the unit making sure to orient it as shown ...

Страница 37: ...ation of the unit by the control circuitry to limit total power consumption A fully charged battery will provide 2 5 hours of treatment depending on the applicator and the pulsed mode used NOTE Even when the battery pack is connected the unit will default to mains power when plugged in USING THE BATTERY PACK To save battery power the Intelect Mobile Stim is equipped with a power off function This ...

Страница 38: ... the anatomy Follow electrode manufacturer instructions Electrotherapy Patient Preparation Electrode Placement Keep electrodes separated during treatment Electrodes in contact with each other could result in improper stimulation or skin burns Output current density is inversely related to electrode size i e the larger the electrode the lower the current density Improper application may result in p...

Страница 39: ...delivery of the prescribed electrotherapy treatment Properly dispose of used Dura Stick Electrodes upon completion of the therapy session Reusable Carbon Electrodes If used for delivery of electrotherapy the Carbon Electrodes must be inserted into the sponges moistened with distilled water prior to placement on the patient These Carbon Electrodes should be secured to the treatment area using the N...

Страница 40: ...rodes NOTE Use of conductive medium or sponges is not required or recommended Dura Stick Electrodes are manufactured to ensure the optimum conductivity during therapy when properly applied Red LEAD WIRE black LEAD WIRE DURA STICK Electrode Instructions Connecting Lead Wires Remove the Dura Stick Electrodes from the protective backing and apply to the treatment area as prescribed Ensure the entire ...

Страница 41: ...ing Lead Wires Insert the lead with the Red electrode connector into electrode Insert the lead with the black electrode connector into the other electrode Make certain the Lead Wires are seated completely into the electrodes RED LEAD WIRE BLACK LEAD WIRE Electrotherapy Patient Preparation continued Reusable Carbon Electrodes secure with nylatex The Nylatex Wraps contain dry natural rubber and may ...

Страница 42: ...y electrotherapy do the following 1 Turn system power ON by pressing the Power On Off button The message Initializing System displays The unit will go through self diagnostics and the home screen displays on the LCD 2 Connect the Lead Wires to the appropriate electrodes To see a list of recommended electrodes and their preparation see pages 35 38 NOTE Do not use unnecessary force to connect the el...

Страница 43: ...type of waveform you intend to use and the number of patients you intend to treat insert the Lead Wire into Channel 1 Channel 2 or both Lead Wire Connections on the Accessory Panel 5 Use the Up and Down Arrow buttons to highlight the appropriate channel 6 Press the Enter button The Waveform screen displays ...

Страница 44: ...s The Parameter screen refreshes and the new parameters are displayed 11 To begin electrotherapy press the START button The timer counts down the output power ramps up and Running displays below the timer NOTE When the therapy time has expired the unit beeps three times During therapy you can press the TIME button to raise or lower treatment time in one minute increments using the up and down arro...

Страница 45: ...ollowing occurs whenever the PAUSE button is pressed the timer pauses the unit beeps quickly 5 times Paused displays below the timer the unit stops emitting output To resume therapy press the PAUSE button or the START button 12 When you have completed treatment remove all electrodes from the patient 13 Turn system power OFF by pressing the Power On Off button The unit beeps once and the blue light...

Страница 46: ...press the Enter button NOTE User protocols can be used on either channel It does not matter on which channel they are created The Waveform screen displays 2 Use the Up and Down Arrow buttons to highlight the appropriate waveform 3 Press the Enter button The Parameter screen displays 4 On the parameter screen use the Up and Down Arrow buttons to highlight the parameter you want to change and adjust...

Страница 47: ...to highlight any unused user protocol If you select the Save as Default protocol this will become the protocol displayed when the waveform is selected on the Waveform screen 8 Press the Enter button to accept the highlighted selection and save your custom protocol The User Protocol Confirmation window displays to indicate that the protocol is now saved as the number you specified 9 Press any butto...

Страница 48: ...sing the Up Arrow and Down Arrow buttons highlight the Retrieve User Protocol option 3 Press the Enter button to accept the highlighted selection A list of user defined protocols displays 4 Use the Down Arrow button to highlight the appropriate protocol As you highlight each protocol a description of the protocol s parameters displays to the right ...

Страница 49: ...rameters of this program and use the appropriate buttons on the Operator Interface to adjust any setting if necessary For example to adjust the time press the up and down arrows on the TIME button 7 To begin therapy perform all the procedures outlined in the section entitled Patient Preparation on page 35 Then continue with step 11 of the section entitled Starting Stopping and Interrupting Therapy...

Страница 50: ...ly assessed to determine the appropriateness of the parameter setting prior to use To select an indication for a patient do the following 1 On the home screen press the Clinical Resources button The Clinical Library window displays 2 Using the Up Arrow and Down Arrow buttons highlight Clinical Indications and press the Enter button The Clinical Indications menu displays ...

Страница 51: ...nu displays highlight the appropriate selection and press Enter The settings from the indication you selected display 4 Review the final indication parameters treatment Make any necessary modifications or corrections 5 To begin therapy continue with the instructions outlined in the section entitled Electrotherapy Patient Preparation on page 35 Then proceed to step 11 on page 41 ...

Страница 52: ... prior to or during therapy To make Intensity and Treatment Time changes touch the respective buttons and use the up or down arrows to advance to the desired settings To change other parameters during therapy do the following 1 On the home screen use the Up and Down Arrow buttons to highlight the channel on which therapy is currently running 2 Press the Enter button to select the highlighted optio...

Страница 53: ...the Up and Down Arrow buttons to highlight the appropriate waveform 3 Press the Enter button The Parameter screen displays 4 On the parameter screen use the Up and Down Arrow buttons to highlight the parameter you want to change and adjust it accordingly 5 Press Enter to accept the parameters The Parameter screen refreshes and the new parameters are displayed 6 Press the Clinical Resources button ...

Страница 54: ... Save as Default protocol This will become the protocol displayed when the waveform is selected on the Waveform screen 8 Press the Enter button to accept the highlighted selection The Default Protocol Confirmation window displays 9 Press any key to confirm the settings You are returned to the Clinical Resources menu ...

Страница 55: ...lay contrast is optimal Restoring Factory Protocols If necessary you can choose to restore the unit s original default waveform parameters when it was shipped to you NOTE This procedure will erase all user defined protocols To restore the unit s original waveform parameters do the following 1 Press the Clinical Resources button The Clinical Library window displays ...

Страница 56: ...e highlighted selection The unit displays the message Restoring Protocols Please wait The user defined protocols are erased and the waveforms are restored to the original parameters Then the Restore Factory Protocols Confirmation window displays 4 Press any button on the Operator Interface You are returned to the Clinical Library window sYSTEM UTILITIES continued ...

Страница 57: ...ical Resources screen displays 2 Use the Down Arrow and Up Arrow buttons to highlight the Language option 3 Press the Enter button to accept the highlighted selection The Language submenu displays 4 Press the Down Arrow and Up Arrow buttons to highlight the appropriate language 5 Press the Enter button to accept the highlighted selection Your unit now displays the language you selected ...

Страница 58: ...e unit do the following 1 On the main window press the Clinical Resources button The Clinical Library screen displays 2 Press the Up Arrow or Down Arrow buttons to highlight the Restore Factory Settings option 3 Press the Enter button to accept the highlighted selection The Restore Factory Settings Confirmation screen displays ...

Страница 59: ...Interface The default power up settings are restored and you are returned to the Clinical Library screen Viewing Unit Version Information Use this utility to determine the unit s software version To do this do the following 1 Press the Clinical Resources button The Clinical Library screen displays ...

Страница 60: ...inued 2 Use the Up Arrow and Down Arrow buttons to highlight the View Unit Information option 3 Press the Enter button to accept the highlighted selection The Unit Version Information window displays 4 Press any key to return to the Clinical Library window ...

Страница 61: ...least one channel is already in use A Wait until the previous therapy session finishes B Press the STOP button to end the therapy session on either channel 106 Warning Overcurrent 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 ...

Страница 62: ...aler or DJO for service Errors and Warnings in these categories indicate an internal problem with the unit that must be tested by DJO or a Field Service Technician certified by DJO before any further operation or use of the system Use of a unit that indicates an Error or Warning in these categories may pose a risk of injury to the patient user or extensive internal damage to the system WARNING ...

Страница 63: ... Wire 1 27313 Channel 2 Lead Wire 1 10648 Nylatex Wrap 2 79967 6 x 8 cm Carbon Electrodes 4 79970 6 x 8 cm Electrode Sponges 4 42044 7 cm 2 75 Round Disposable Electrodes 4 per pack 1 27933 User Manual CD ROM 1 Optional Accessories Ref Description 27478 NiMH Battery Pack 27467 Intelect Mobile Carrying Bag Mains Power Cords Ref Type Qty 21284 Euro 1 78121 US 1 20971 Australian 1 20972 Swiss 1 20973...

Страница 64: ... wet inside until inspected and tested by a Service Technician Certified by DJO To clean the Lead Wires disconnect them from the unit and wipe them down with a clean lint free cloth moistened with water and mild antibacterial soap To clean the reusable carbon electrodes remove them from the Lead Wires and wipe them down with isopropyl alcohol Repeat this procedure for the sponges as well EU Direct...

Страница 65: ... 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 LIABLE IN ANY EVEN...

Страница 66: ...English DJO is an ISO 13485 Certified Company DJO France SAS Centre Européen de Fret 64990 Mouguerre France T 1 800 592 7329 USA T 1 317 406 2209 F 1 317 406 2014 chattgroup com 2011 DJO LLC All rights reserved ...

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