Chattanooga Intelect Mobile 2 Combo User Manual Download Page 2

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CONTENTS

INTELECT

MOBILE 2 ULTRASOUND USER MANUAL

FOREWORD 4

INTENDED USER PROFILE

INTENDED ENVIRONMENT FOR USE

INTENDED USE

PRECAUTIONARY INSTRUCTIONS

GENERAL TERMINOLOGY

SYSTEM SOFTWARE SYMBOLS

DESCRIPTION OF DEVICE MARKINGS

VACUUM MODULE MARKINGS

ULTRASOUND INDICATIONS

INDICATIONS 7

CONTRAINDICATIONS 7

ADDITIONAL PRECAUTIONS

PRODUCT DESCRIPTION

COMPONENTS 8

HEAD 8

CART 8

BATTERY MODULE (OPTIONAL)

ULTRASOUND APPLICATORS

VACUUM MODULE (OPTIONAL)

OPERATOR INTERFACE

VACUUM MODULE OPERATOR INTERFACE

INTELECT MOBILE 2 SET COMPONENTS

HEAD 14

LEADWIRES 14

POWERCORD 14

STIM SET INCLUDES

US SET INCLUDES

ULTRASOUND APPLICATOR

HEAD TO CART FIXATION

CONNECTING CABLES AND INSERTING PLUGS

INITIAL RECEIPT

IF UNIT SUPPLIED WITH OPTIONAL BATTERY

IFU DOWNLOAD

DEVICE CONNECTED TO THE MAINS

DEVICE WORKING ON BATTERY

DEVICE LIGHT INDICATORS

FRONT PANEL INDICATORS

ON/OFF BUTTON BLUE INDICATOR:

PLAY/PAUSE BUTTON BLUE INDICATOR:

SYSTEM SPECIFICATIONS AND DIMENSIONS

POWER

ULTRASOUND SPECIFICATIONS

OUTPUT POWER

GENERAL SYSTEM OPERATING AND STORAGE
TEMPERATURE 21

ULTRASOUND PATIENT PREPARATION

Summary of Contents for Intelect Mobile 2 Combo

Page 1: ...EN ...

Page 2: ... INTERFACE 9 VACUUM MODULE OPERATOR INTERFACE 10 INTELECT MOBILE 2 SET COMPONENTS 14 HEAD 14 LEADWIRES 14 POWERCORD 14 STIM SET INCLUDES 14 US SET INCLUDES 14 ULTRASOUND APPLICATOR 15 HEAD TO CART FIXATION 16 CONNECTING CABLES AND INSERTING PLUGS 17 INITIAL RECEIPT 17 IF UNIT SUPPLIED WITH OPTIONAL BATTERY 17 IFU DOWNLOAD 17 DEVICE CONNECTED TO THE MAINS 18 DEVICE WORKING ON BATTERY 18 DEVICE LIGH...

Page 3: ... SHORT CUTS 47 UNASSIGN SHORT CUT 49 CLINICAL RESOURCES 50 MODALITY WAVEFORM DESCRIPTIONS 53 TROUBLESHOOTING 55 GENERAL ACCESSORIES 56 BATTERY 56 ULTRASOUND APPLICATORS AND GEL 56 CLEANING THE INTELECT MOBILE 2 57 CALIBRATION REQUIREMENTS 58 DEVICE DISPOSAL 58 INSTRUCTION FOR SOFTWARE UPGRADE 58 IFU DOWNLOAD 58 INSTALLATION OF BATTERY 58 REPLACEMENT BATTERY 58 WARRANTY REPAIR OUT OF WARRANTY REPAI...

Page 4: ...he device is intended to be operated in the clinic and remote treatment locations The intended clinical conditions for use are a typical clinic setting including chiropractic clinics physical therapist clinics athletic training rooms or other rehabilitation settings The patients home will also be a frequent use setting where the clinician treats the patient in his her own home environment FOREWORD...

Page 5: ...k to previous screen Settings Indicates a USB Flash Drive is Inserted Indicates Battery Level Indicates more content can be viewed by swiping vertically Indicates more content can be viewed by swiping horizontally Indicates more content can be viewed by scrolling Close window exit full screen Confirm Save Data Edit Guidelines Assign to Pain information Run again Exit Export Import Delete Delete al...

Page 6: ...y appear on the device Refer to Instructional Manual Booklet Warning Caution or Danger Electrical Type BF Equipment Ultrasound Play Pause ON OFF Manufacturer Date of manufacture Catalogue number Serial number Fragile handle with care This end up Keep dry Temperature Range Relative Humidity Range Atmospheric Pressure Range Test agency CE Mark of Conformity with notified body number Alternating curr...

Page 7: ... Do not use over or applied to the eye Do not use over a pregnant uterus Tissue necrosis might result if the device is used on ischemic tissues in individuals with vascular disease where the blood supply would not keep up with the metabolic demand Do not use Intelect Mobile 2 on patients who have or have had implantable neurostimulating cardiac demand pacemakers ICD or other implantable electronic...

Page 8: ...uipment is to be used only under the prescription and supervision of a licensed medical practitioner COMPONENTS Throughout these instructions the terms left and right referring to the machine sides are from the perspective of a user standing in front of the unit The components of the Intelect Mobile 2 ELECTROTHERAPY are shown below HEAD CART BATTERY MODULE optional Battery is an 18V 3350mAh LiIon ...

Page 9: ...nctions and controls necessary for operator access to all operator utilities modalities and parameters for modification and system set up Color Display and touch screen 1 Adjustment dial 2 Play pause button 3 On Off button Press and hold 2 sec the button to switch OFF the device Handle Colour Touch Screen Play pause button Adjustment dial Ultrasound applicator support On Off button Ultrasound appl...

Page 10: ...ire or personal injury DO NOT permit foreign materials liquids or cleaning agents to enter the unit including but not limited to inflammables water and metallic objects to prevent unit damage malfunction electrical shock fire or personal injury Before each use inspect Ultrasound Applicator for cracks which may allow the ingress of conductive fluid Before each use inspect Applicator cables STIM cab...

Page 11: ...y and if not installed and used in accordance with instructions for use may cause harmful interference to other devices in the vicinity Harmful interference to other devices can be determined by turning this equipment on and off Try to correct the interference using one or more of the following Reorient or relocate the receiving device Increase the separation between the equipment Connect the equi...

Page 12: ...se unit damage malfunction electrical shock fire or personal injury Your unit 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 Device is not designed to be used in oxygen rich environment Explosion hazard if the device is used in the presence of flammable anesthetic mixture wi...

Page 13: ...wer Cable 2m Black EU 15 0146 Wall Power Cable 2m Black UK 15 0147 Power Cable 2m Black AUS INTELECT MOBILE 2 SET COMPONENTS COMBO SET INCLUDES 15 0133 INTELECT MOBILE 2 COMBO 79967 Carbon electrodes 70010 STIM lead wires 6522055 Chattanooga straps 42198 Electrodes gel 15 0144 46 47 Power cord 13 1604 Printed Quick Start Guide 15 0142 5 CM2 Ultrasound Applicator 4248 Ultrasound Gel Bottle 15 1140 ...

Page 14: ...plicator that makes contact with the patient during Ultrasound or Combination therapy 2 Applicator The assembly that connects to the system and incorporates the Applicator head 3 LED The component of the applicator that indicates if the Applicator is coupled or uncoupled on the treatment area ULTRASOUND APPLICATOR ...

Page 15: ...ies and applicators used for the various modalities of the System The fixation of the head to the cart is magnetic Remove the Intelect Mobile 2 device and cart from the shipping carton Visually inspect for damage Report any damage to the carrier immediately To assemble the Mobile 2 Head to the Cart follow these steps 1 Insert device front bottom on the cart lip 2 Release device back gently on the ...

Page 16: ...THE DEVICE First time use always use mains power even if battery connected Insert the power cord into the back of the unit insert the plug into a power outlet do not position the Intelect Mobile 2 in such a way that makes it difficult to disconnect from the mains power Switch device on with ON OFF switch switch on the back of the unit 1 The Initialisation screen below will be shown for a few secon...

Page 17: ...d function on the Home Screen DEVICE WORKING ON BATTERY 1 Press the ON OFF button on the LCD Front panel as shown below 2 Select desired function on the Home Screen shown below ON OFF Button STOP TREATMENT AND TURN OFF THE DEVICE Press Play pause button to pause treatment then press stop on touch screen If device is on mains power press the on off button on the front panel then turn off the switch...

Page 18: ...Right 2 Behaviour Steady when modality is selected and output is not active Flashing when output is active Quickly flashing when treatment is interrupted and user action is requested ON OFF BUTTON BLUE INDICATOR steady ON from device connection to the mains Flashing while powering ON OFF PLAY PAUSE BUTTON BLUE INDICATOR It flashes when user can start resume a treatment Otherwise steady DEVICE LIGH...

Page 19: ... 96cm 10 1kg Device on cart 111 cm ULTRASOUND SPECIFICATIONS Frequency 1 MHz 3 MHz Duty Cycles 10 20 50 Continuous Pulse Repetition Rate 16 48 or 100 Hz Pulse duration 1 31 25 ms Max ON 31 25 ms Min OFF 5ms OUTPUT POWER US applicator Frequency 1 cm2 2cm2 5cm2 1MHz 3MHz 1MHz 3MHz 1MHz 3MHz Effective Radiating Area ERA INTL cm2 1 0 9 1 5 1 2 5 2 7 Max Output power in Continuous mode 2W 1 8W 3W 2W 5W...

Page 20: ...ressure 50kPa to 106kPa Time required for the Intelect Mobile 2 to warm from the minimum storage temperature between uses until the Intelect Mobile 2 is ready for its INTENDED USE when the ambient temperature is 20 C 5h Time required for the Intelect Mobile 2 to cool from the maximum storage temperature between uses until the Intelect Mobile 2 is ready for its INTENDED USE when the ambient tempera...

Page 21: ...ssion in a circular motion The area treated should be Twice the diameter of the applicator For 5cm2 US applicator three times the diameter of the applicator if output power 4 W Continuous mode The applicator should always be held by the grip and not by the Ultrasound Applicator head 4 If US Coupling is On the Applicator is properly coupled to the patient and administering ultrasound when the LED i...

Page 22: ...EEN DESCRIPTION 1 Menu Bar 2 Main Area 3 Channel Bar Each screen contains the following areas Menu Bar Located at the top of each screen and lists the current screen name Go to Home Screem Go to Previous Screen Current Screen Name Battery level USB Black connected Grey inacctive Settings ...

Page 23: ...23 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL Main area Located under the menu bar this area displays icons unique to the current screen 1 Menu Bar 2 Main Area 3 Channel Bar ...

Page 24: ...sound status box Stim Ch 1 status box Stim Ch 2 status box Intensity Remaining treatment time Treatment Progress Status Channel status possibilities Indicates the channel is available for use Indicates an ultrasound treatment is running with the left L applicator Indicates a treatment for the channel is currently being setup but treatment has not yet begun Indicates a treatment for the channel is ...

Page 25: ...djust the display brightness select Brightness button The brightness range is 0 dimmest to 100 brightest in increments of 10 Default setting is 80 To adjust the volume of sound select the volume button The volume range is 0 off to 100 loudest in increments of 10 Default setting is 40 Pressing the keyboard sounds button selects either on or off for keyboard sounds Default setting is ON Pressing the...

Page 26: ...drive 3 in the setting menu eject the USB drive to enable safe removal from the Mobile 2 device 4 The format of the file is a bitmap file and it is date Time coded in the filename Note The print screen function should not be used during treatment HOME SCREEN The Intelect Mobile 2 Home screen provides access to all of the system modalities and functions The Home screen has the following information...

Page 27: ...ement Guidelines Save Overwrite default settings or Custom Protocols 1 Touch to activate 2 Adjust with Adjustment dial Clockwise Increase Counterclockwise Decrease Note When a parameter is not adjustable the parameter box is faded Save to Treatment Data Parameter Submenu Screen Touch to switch ON or OFF 1 Touch to activate 2 Adjust with Adjustment dial Clockwise Increase Counterclockwise Decrease ...

Page 28: ... following information Instructions for optimal US applicator use at the left side of the screen Images illustrating US treatment area and recommended applicator choice at the right side of the screen Swipe vertically to see more Touch image to view in full screen mode View in full screen mode Swipe horizontally for more ...

Page 29: ...s of Chattanooga Ultrasound Applicators will not work with the Intelect Mobile 2 2 From the home screen select the Ultrasound icon 3 SET UP TREATMENT On the treatment review screen you can adjust treatment parameters to desired level Refer to page for detailed description of the Treatment Review Screen Note Never start with intensity adjustment first adjust all other parameters and set Intensity j...

Page 30: ...30 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL 4 START TREATMENT Press the START button to begin the therapy 5 PAUSE TREATMENT Press the Start Pause button ...

Page 31: ...SER MANUAL To resume treatment press the Start Pause button again Note Pause applies to the selected channel only 6 STOP TREATMENT First pause treatment by pressing the Start Pause button Then press the Stop treatment box on the treatment review screen ...

Page 32: ... from the Pause status When treatment has completed the Treatment Summary screen will appear with the following options Save the treatment protocol to the Custom Protocols cfr Page Assign to Assign therapy information to treatment data Exit Modality and return to home screen Settings of completed treatment ...

Page 33: ...e selected by the user and the suggested algorithm will select the parameter settings All settings can be edited to suit appropriate patient treatment prescription and patient comfort COMPLETE THE FOLLOWING STEPS TO START AN SPS PROTOCOL 1 Select SPS from the Home Screen 2 Select the BODY PART you wish to treat Note the selected body part will be highlighted and moving your finger to another area ...

Page 34: ...34 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL 3 Select INDICATION Touch to select Swipe vertically to see more 4 Select specification Touch to select ...

Page 35: ...ettings are displayed and you can adjust parameters to desired level Refer to page for detailed description of the Treatment Review Screen Note Never start with intensity adjustment first adjust all other parameters and set Intensity just before starting treatment Parameters Swipe vertically to see more parameters 1 Touch to activate 2 Adjust with Adjustment dial Clockwise Increase Counterclockwis...

Page 36: ...36 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL 7 START TREATMENT Press the START button ...

Page 37: ...nt data can be assigned to a folder at any time of the treatment set up running or completed but data will only be saved once the treatment is finished and channel is free for next treatment after pressing EXIT button on Treatment Summary screen The TREATMENT DATA screen appears Save treatment data to an existing ID folder or create and save to a new ID folder Select save to existing ID Create sav...

Page 38: ...38 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL SAVE TREATMENT DATA TO A NEW ID Enter ID and Save VIEW AND MANAGE TREATMENT DATA Press the TREATMENT DATA ICON on the home screen ...

Page 39: ... 2 ULTRASOUND USER MANUAL 1 VIEW Treatment Data Select desired ID folder The TREATMENT HISTORY is displayed including all previously saved treatment sessions ranked chronologically Select session to view Treatment Summary for that session ...

Page 40: ...40 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL 2 DELETE Treatment Data Delete all IDs Delete one ID ...

Page 41: ...41 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL Delete all treatment sessions Delete one session ...

Page 42: ...tom protocols to be defined SAVE A CUSTOMIZED PROTOCOL A new custom protocol may be saved at any time using SAVE button 1 Touch SAVE on the TREATMENT REVIEW or TREATMENT SUMMARY screen 2 Select SAVE TO CUSTOM PROTOCOLS Note it is also possible the overwrite the default settings of the waveform instead of saving to custom protocols ...

Page 43: ...l library is displayed where you can save the protocol as NEW custom protocol or OVERWRITE an existing custom protocol Select and overwrite existing protocol Create new custom protocol Alphabetical list Swipe to see more CREATE NEW CUSTOM PROTOCOL Enter Custom Protocol Name and Save ...

Page 44: ...44 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL VIEW AND MANAGE CUSTOM PROTOCOLS Touch the CUSTOM PROTOCOLS icon on the Home Screen 1 VIEW Custom Protocol Select desired Custom Protocol ...

Page 45: ...LE 2 ULTRASOUND USER MANUAL The TREATMENT REVIEW SCREEN is displayed showing the protocol settings Start treatment or perform other actions as described in the Ultrasound Operations section 2 DELETE custom protocol Delete all protocols ...

Page 46: ...2 custom protocol shortcut assignments on the home screen ASSIGN SHORTCUT Complete the following steps to assign a home screen shortcut Unassigned Shortcut icons appear grey in colour Press one of the unassigned Shortcut icons on the Home screen Select the desired protocol in the Custom Protocol library ...

Page 47: ...47 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL Shortcut assigned on Home screen Once assigned the shortcut icon becomes the colour associated with the modality it contains ...

Page 48: ...ol From the Home screen press and hold the shortcut icon you wish to unassign The unit will display a text box asking Remove My Custom Protocol 1 shortcut Select No to quit the unassignment process and return to the Home screen or Yes to continue with the unassignment process After selecting Yes the previously assigned shortcut will no longer appear on the Home screen ...

Page 49: ... to use with the patient The modality and waveform descriptions provide information about the physical background and physiological effects of the different electrotherapy waveforms and ultrasound therapy aiming to assist the user in selecting the appropriate modality waveform Complete the following steps to view the Clinical Resources Library Press the Clinical Resources Library icon on the Home ...

Page 50: ...MANUAL 2 Touch the body part for which you wish to view information Choose either anterior on left of screen or posterior on right of screen 3 The available images for the selected body part are displayed Touch the image you want to see in full screen mode ...

Page 51: ...51 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL 4 Full screen image Close full screen mode ...

Page 52: ...AL MODALITY WAVEFORM DESCRIPTIONS Complete the following steps to view the ultrasound or waveform descriptions 1 Press the Ultrasound description icon on the Clinical Resources screen 2 Select the desired waveform in case of Electrotherapy Waveform description ...

Page 53: ...53 USER INTERFACE EN INTELECT MOBILE 2 ULTRASOUND USER MANUAL 3 The modality or waveform description is displayed ...

Page 54: ... MANUAL TROUBLESHOOTING 1 All system messages warning messages and fault messages that are generated by the device are self explanatory excepting system error 2 If System error occurs note error code and contact DJO selling dealer or DJO Service Department ...

Page 55: ... 1136 Mobile 2 Cart BATTERY Not available at launch Model Number Description 14 1086 Battery ULTRASOUND APPLICATORS AND GEL Model Number Description 15 0140 G16 Ultrasound Applicator 1 cm2 15 0141 G16 Ultrasound Applicator 2 cm2 15 0142 G16 Ultrasound Applicator 5 cm2 4248 Conductor Transmission Gel 9 oz Bottle ...

Page 56: ...uld be performed daily Do not submerge the system in liquids Should the unit accidentally become submerged contact the dealer or DJO Service Department immediately Cleaning the LCD Screen Clean the LCD with a clean dry cloth in the same way as cleaning the computer monitor screen Do not use abrasive materials or chemicals or liquids Cleaning instruction for the Ultrasound applicator The sound head...

Page 57: ...ect Mobile 2 product tab 3 Complete the registration form to be informed about new product software version availability and IFU updates if not already done before 4 Go to documents tab 5 Click on the latest version of your Intelect Mobile 2 device COMBO US or STIM User manual to download Nota a pdf viewer is required to display IFU A hard copy of the IFU can be requested from DJO either by regist...

Page 58: ...ill relieve the manufacturer of its liability and responsibility for safe system operation This will automatically void the warranty even before the end of the warranty period The warranty period for accessories is 90 days Accessories consist of Lead Wires and Electrodes The warranty period for the Therapy System Cart and Ultrasound Applicators is one year 12 months This Warranty Does Not Cover Re...

Page 59: ...ions CISPR 11 Group 1 The Intelect Mobile 2 uses RF energy only for its internal function Additionally the Intelect Mobile 2 contains a Bluetooth radio module Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A The Intelect Mobile 2 is suitable for use in all estab...

Page 60: ...t 50 relative humidity Floors should be wood concrete or ceramic tile If floors are covered with synthetic material DJO recommends implementing additional controls to maintain relative humidity to at least 50 Communicate these ESD precautionary procedures to healthcare staff contractors visitors and patients Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 2 kV for power s...

Page 61: ...ol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40...

Page 62: ... 6 3 3 8 7 3 100 12 20 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for...

Page 63: ...sion Street Vista CA 92081 8553 U S A www DJOglobal com DJO France SAS Centre Européen de Frêt 3 rue de Bethar 64990 Mouguerre France T 33 0 5 59 52 86 90 F 33 0 5 59 52 86 91 DJOglobal com 09 2019 DJO 13 1602 EN Rev A ...

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