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InTENSity Professional Series InTENSity Professional Series CX4

1. 4 Channel Selection Select the channels for desired treatment When channel 1 is selected channels 2 3 and 4 are still available for another therapy When channels 1 2 or 3 4 are selected both channels have the same parameters Only the intensity can be set differently Parameters Adjust the parameters by touching the desired parameter button Change the value by rotating the central control dial NOTE Some parameters have more options to choose from and on the next screen another list appears from which to choose from Touch the button if you want to switch to parameters of channels 3 amp 4 O Chronic Pain 2 Electrodes nu Sym Channel Mode Biphasic Single Frequency Phase Dur 50pps 300us ON OFF Time Continuos 5 Treatment Time Adjustment 6 Start Therapy InTENSity Professional Series CX4 EX4 EICHIES LIE TRI EST Touch the timer The color will change to orange Adjust the treatment time with the central control dial Treatment Time IL Sym Channel Mode Biphasic Single Frequency Phase Dur 50pps 300us ON OFF Time Continuos CC CV Once your parameters and timers are set start the therapy by touching the output intensity on the bottom of the screen The color will change to orange WET Urey J Sym Channel Mode Biphasic Single Frequency Phase Dur 50pps 300us ON OFF Time Continuos CC CV Yo
2. Beat H Hz Stepping 1Hz Intensity CC 0 100mA Stepping 0 5mA CV 0 100V Stepping 0 5V Treatment Time 1 60 Minutes IF 4P requires the use of at least four 4 electrodes at all times as well as criss crossing the electrodes as indicated below InTENSity Professional Series CX4 EX4 IFC Interferential Premodulated 2 Pole Premodulated Current is a medium frequency waveform Current comes out of one channel two electrodes A bipolar technique in which the two frequencies are mixed inside the machine prior to tissue delivery PARAMETERS Carrier Frequency Carrier frequency is the base frequency of the alternating current Beat Frequency Cycle Time Ramp Time Occurs when two waveforms are in and out of phases The difference between the two frequencies produces the modulated effect i e Beat H of 4000 and Beat L of 4150 will yield a 150 pps beat frequency Cycle time refers to the time that the current is On and Off in seconds Example For a cycle time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp time is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a cycle Waveform Specifications Stimulator Output Parameters CC Constant Current or CV Constant ee 1 Beat H Hz Stepping 1Hz Intensity CC 0 100mA Stepping 0 5mA CV 0 100V Stepping 0 5V Trea
3. Check the applicator and cable regularly for damage Maintenance 47 Troubleshooting InTENSity Professional Series CX4 EX4 Error Codes Error Codes Ultrasound applicator is without Output pause system recover output when 101 Electrotherapy connection to skin detecting contact Ch 1 has bad contact Parameters is set upper limit Parameters remain in upper limit Electrotherapy Ch 2 has bad contact Parameters is set lower limit Parameters remain in lower limit System stops electrical stimulation output 103 Electrotherapy Check pads and lead wires before restarting Choose occupied Nothing The operation is invalid Ch 3 has bad contact channel operation Touch aa 104 Electrotherapy sarees do aM i Nothing The operation is invalid Ch 4 has bad contact is not allowed TR GHGS Attempting to save a new favorite protocol after a Tode option that pannat Nothing The operation is invalid ree etenmcapacit system memory maximum has been reached be changed y paniy The operation is invalid Ultrasound applicator is disconnected from the system during treatment session System stops ultrasound treatment output Ultrasound handle is not connect Ultrasound handle is not connected when the ultrasound treatment is selected 108 Ultrasound applicator Ultrasound applicator is too hot overheats System is too hot let it cool down 109 Electrotherapy Ch 1 short circuit 110 Electrotherapy Ch
4. 2 Repairs under warranty do not extend the warranty period either for the device or for the replacement parts 3 The following is excluded under the warranty e All damage which has arisen due to improper treatment e g nonobservance of the user instruction e All damage which is due to repairs or tampering by the customer or unauthorized third parties e Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service center e Accessories which are subject to normal wear and tear 4 Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim B4 InTENSity Professional Series CX4 EX4 NOTES InTENSity Professional Series CX4 EX4 Notes NOTES 55 Better Living Rosco Emevica Manufactured for Roscoe Medical 21973 Commerce Parkway Strongsville Ohio 44149 Ph 800 3 ROSCOE 376 7263 www roscoemedical com
5. Display Electrotherapy Therapy Button Patient Kill Switch Button Central Control Dial with Light Ring Patient Remote Kill Switch Connection Channel 1 Lead Wire Connections Channel 2 Lead Wire Connections Channel 3 Lead Wire Connections n 2 Prof2ssiona Jeries D 26 InTENSity Professional Series CX4 EX4 Operating Instructions OPERATOR CONTROLS CONT DEVICE SYMBOLS 17 Power Button 18 Carry Handle 19 Grounding Test Post 20 USB Diagnostic Port 21 On Off Switch 22 Power Cord Connection BF Application Part Ultrasound Applicator Connection Patient Interrupt Button Connection Please refer to the manual for detailed instructions USB Diagnostic Port is used for repairs and or maintenance issues and should only be used by a certified technician 27 Product Description The InTENSity Professional Series is a family of clinical therapy devices which offers the practitioner a wide range of treatment options These devices share an identical control panel equipped with a full color screen making treatment set up easier than ever A few simple key presses are all you need to quick start a treatment The User Interface intuitively groups and displays all the options for a modality setup on the large touch screen to ensure that treatment parameters can easily be selected and adjusted INTENSITY EX4 The InTENSity EX4 is equipped with two or four completely identical electrotherapy channe
6. HOME Y Electrotherapy Y Electrotherapy x System Settings 2 TERTII 82 Combination 0 System Settings Product Description MAIN THERAPY DISPLAY After navigating from the Home Menu the below screen will be the main therapy display content subject to change This display is organized in three 3 sections with information relating to the therapy selected for intended use 1 Navigation Bar 2 Selected Parameters 3 Channel Tab Information C KICI Manual Freq P Dur 2 B Hz 300us ON OFF Time Ramp Continuos 0 0 CCICV CH T 29 Product Description TOUCHSCREEN DISPLAY NAVIGATION BAR Return to previous screen EN Return to Home screen Page Number The number of pages in multi page menu screens or treatment step number Favorite Store therapy settings or a programmed sequential protocol in a favorite Pause Pause treatment The output current decreases to 0 and the treatment timer suspends counting down Start Start Continue treatment The output current increases to the previous value and the treatment timer resumes counting down m Accept the selected option Stop Stop the treatment reset the treatment time and intensity Continue o 2 Channel Indicator 3 Remaining Treatment Time 4 Output Value 5 Unit of Output Value mA InTENSity Professional Series CX4 EX4 ELECTROTHERAPY TREATMENT SCREEN KE ui ninm IE THEE IL
7. electrode Stimulation is Ineffective End of life The InTENSity Professional Series contains materials that can be recycled and or are noxious to the environment Specialized companies can dismantle the unit and sort out these materials When you dispose of the unit find out about local regulations concerning waste management 50 InTENSity Professional Series CX4 EX4 Safety and Performance Standards IEC 60601 1 General requirements for the safety of electrical medical systems including Annex 1 national differences for Australia Canada and the United States Safety Class According to IEC 60601 1 Class type BF IEC 60601 2 5 Particular requirements for the safety of ultrasonic therapy equipment IEC 60601 2 10 Particular requirements for the safety of nerve and muscle stimulators This equipment complies with all requirements of the Medical Device Directive 93 42 EEC Medical Device Classification 21 CFR 1050 10 This equipment complies with all requirements of 21 CFR1050 10 Performance Standard for Ultrasonic Therapy devices 21 CFR 898 This equipment complies with all requirements of 21 CFR 898 Performance Standard for electrode lead wires and patient leads InTENSity Professional Series CX4 EX4 EMC Table EMC Details HF emissions according to Medical electrical devices such as the InTENSity Professional Series CISPR 11 The InTENSity CX4 device is suitable S f
8. in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people InTENSity Professional Series CX4 EX4 Theoretically it is not possible to exactly predict the field strengths of fixed transmitters such as base stations for radio telephones and land mobile radios amateur radio stations AM and FM radio and TV broadcasting To determine the electromagnetic environment in relation to the fixed transmitters an electromagnetic site survey should be considered If the measured field strength in the location where the InTENSity Professional Series device is to be used exceeds the above compliance levels the InTENSity Professional Series device should be monitored in order to ensure that it is functioning as intended If unusual features are noticed additional measures may be necessary such as re orienting or relocating the InTENSity Professional Series device Above the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V m Hecommended separation distances between portable and mobile RF telecommunications 4 series and the InTENSity Professional Series device are in the following table The InTENSity Professional Series device is intended for operation in an electromagnetic environment where RF disturbances are monitored The customer or user of the InTENSity Professional Series device can help prevent electromagnetic interference by maintaining a min
9. or detergents with ammonia Care and Storage of Electrodes e The life of the electrodes varies depending on skin conditions storage temperature the amount of use type of stimulation and stimulation site e f electrodes begin losing adhesion gently rub one or two drops of water onto the gel surface and allow them to quickly air dry Oversaturation with water will reduce the adhesive properties e Then place them back on the protective liner and in the orginal resealable bag sealing tightly to prevent air from drying out the electrodes e Between uses store in a cool dry place e The electrodes are intended for single patient use only e f irritation occurs discontinue use and consult your clinician e Always use the electrodes with CE mark or are legally marketed in the US under 510 K procedure InTENSity Professional Series CX4 EX4 Cleaning the Lead Wires and Cables Periodically wipe the lead wires clean with a cloth dampened in a mild soap solution and then gently wipe them dry Use of rubbing alcohol on the lead wires will damage the insulation and dramatically shorten their life Ultrasound Applicator To prevent corrosion clean and dry the contact surface immediately after use Make sure that no ultrasound gel remains on the applicator We further recommend cleaning the applicator and cable daily using lukewarm water The applicator can be disinfected using a cloth moistened with a 7096 alcohol solution
10. placed or lose contact with the skin Make sure the current amplitude is set to O mA when you apply or remove the electrodes InTENSity Professional Series CX4 EX4 Navigation This manual contains instructions for both the InTENSity EX4 amp CX4 For the InTENSity EX4 set up instructions are on pages 33 37 For the InTENSity CX4 set up instructions for all modalities are on pages 33 45 Electrotherapy Set Up Clinical Protocols 2 Clinical Protocols cont e Use the central control dial to ES E 1 Home scroll through the pages then select Hu ow e The Home Menu gives access the desired clinical protocol button to all functions of the unit HOME Acute pain e For more information about the 2 Electrodes e Select the Electrotherapy button l de XN Electrotherapy clinical protocol press the i Y OO button next to the desired protocol 2 Electrodes Chronic Pain 4 Electrodes 2 Clinical Protocols Circulation e The Electrotherapy Menu gives you e Use the central control dial to scroll access to the following functions through the information The last page Pu E 1 Clinical Protocols Steir iene will show suggested electrode 2 Favorites placement Acute Pain i Bl Clinical Protocols 2 Electrodes 3 Manual Operation e e Select Clinical Protocols button Favorites 200 Navigation Electrotherapy Set Up Clinical Protocols cont 3
11. sents Rx RR Rx 8 Ultrasound Warnings l l 8 9 Cautions amp General Precautions LLL 9 10 Intended S6 2222222 Pu cee eee case tenes ERE E dde 11 Electrotherapy Indications amp Contraindications 11 Ultrasound Indications amp Contraindications 12 Adverse EMects scuole RE RRRERREREXEERAWE E RAE 13 Applicator Movement Of Ultrasound 13 Potential Adverse Effects Of Ultrasound 13 Patient Susceptibility 0 25 363 3 ac rbd ee ER gra tae 19 COUDING Sese menpERERCERE ENS PE EMEN enue cue dade nd 13 Parameter Definitions lesse 13 22 Waveform Specifications Lr 14 22 IF 4P IFC Interferential Traditional 4 Pole 14 IFC Interferential Premodulated 2 Pole 15 TENS Biphasic Asymmetrical amp Symmetrical 16 POSS ui 2 ba ed eae G eh uo dui 9083 9 uiuos die dodo dee eee 17 Pigh VOM s sa s aeaea a eee aa a a A E a AE EAA A AAE E AEA 18 IICFOGHITODE uw za siete ened weasdEWSEessicedsxd sd s 19 NIG stat aogucune tau x ded oe pees E cit d iE e rare ae ee ae A 20 Ultrasound Specifications 0 0c eee ee eee 21 22 Package Contents 00cc sence eee e eee eee 23 Operating Instructions llle 24 27 EX4 Operating Controls 000 ce eee 24 25 CX4 Operating Controls llli 26 27 Prod
12. the MD J treatment time with the central control dial Adjust the parameters by touching the desired parameter button and change the value with the central control dial j Navigation Combination Therapy Set Up Manual Operation cont 5 Setting Ultrasound Parameters Once you are finished setting the electrotherapy parameters press the Ultrasound button Select the desired ultrasound frequency by pressing the buttons NOTE Some parameters have more options to choose from and on the next screen another list appears from which to choose from Treatment Time Adjustment Touch the Timer button if you need to change the treatment time set in step 4 The color will change to orange Adjust the treatment time with the central control dial Adjust the parameters by touching the desired parameter button and change the value with the central control dial 44 A 9p OC Beat Low Beat High 4Hz 4Hz rein m 9 Ultrasound p 3 CC CV 9 Y Storing Your Favorite Settings When a treatment screen is completely set as required you can save those settings as a favorite for later use As long as the treatment has not been started a store button will be available on the navigation bar To store your settings to Favorites touch the store button Enter the name of your favorite using the keyboard Press wh to store your favorite u
13. ultrasound waves The ultrasound frequency determines the penetration depth which has the largest value at 1 MHz and the lowest value at 3 MHz Expressed in 96 defines the ratio of the pulse duration to the pulse repetition time Ultrasound can be applied in pulsed or in continuous mode When the Duty Cycle is set to 10096 the apparatus operates in continuous mode Duty Cycle Expressed in cm defines the cross sectional area of the ultrasound beam see technical specifications for details The Effective Radiation Area is fixed and defined by the size of the ultrasound applicator Effective Radiation Area ERA Expressed in Watt cm2 is the quotient of Ultrasound Power and Effective Radiation Area The ultrasound output display can be toggled between Watt and Watt cm2 In pulsed mode the Amplitude during the pulse is displayed The time averaged Amplitude can be obtained by multiplying this value by the Duty Cycle Ultrasound Amplitude Ultrasound Parameters Duty Cycles 1096 10096 Continuous Stepping 1096 1 9 ms set by Duty Cycle Pulse duration Waveform Specifications Output Power Duty Factor lt 70 for 1 cm 0 1W 3 0W 20 for zu level above 1096 of maximum Output Accuracy Amplitude Duty Factor gt 8096 2 0W cm Duty Factor lt 70 3 0W cm Treatment Timer 0 30 min 0 1 min 5 cm Applicator ERA Effective Radiation 5 cm Area 1 cm Applicator ERA Effective R
14. 2 short circuit Over current on channel Check pads and lead wires 111 Electrotherapy System stops ultrasound treatment output Ch 3 short circuit 112 Electrotherapy Ch 4 short circuit 117 Internal operating temperature System is too hot is too high System stops ultrasound treatment output Attempting to perform an ultrasound treatment without an applicator connected to the system System stops ultrasound treatment output InTENSity Professional Series CX4 EX4 Troubleshooting Replace lead wires annually e Please follow the directions on the electrode packaging for the NC AUTION care of the electrodes The life of an electrode varies depending on skin conditions skin preparation storage and climate Replace e Electrical safety of the device relies on a properly grounded electrical electrodes that no longer stick connection via the power cord e NOTE If the following measures fail to alleviate the problem e To ensure continued compliance with the 21 CFR 1050 10 standard lassa cslliha SPEED Sone Or NOU SUBE p this unit should be adjusted and safety tested once each year P g ros pone Procedures specified in the service manual should be followed Be Ad i ee ee en Problem Possible cause Solution authorized by the manufacturer It is also recommended that a service history record be maintained In some countries this is even obligatory Adapter contact failure Ensure adapter is connect e U f di f f d h
15. 3 Rubber Electrode 4 pk 3 x 23 5 Strap for Rubber Electrodes 78 Lead Wires 2 bag Operating Instructions InTENSity Professional Series CX4 EX4 OPERATOR CONTROLS INTENSITY EX4 ULL CT EX4 Power LED Indicator Touch Screen Display Electrotherapy Button Patient Kill Switch Button Central Control Dial with Light Ring Patient Remote Kill Switch Connection Channel 1 Lead Wire Connections Channel 2 Lead Wire Connections 9 Channel 3 Lead Wire Connections a 10 Channel 4 Lead Wire Connections 11 Clinical Protocol Button 12 Favorites Button SEE ae eS OO Prof2ssional Jeries 24 InTENSity Professional Series CX4 EX4 Operating Instructions OPERATOR CONTROLS CONT DEVICE SYMBOLS 13 14 15 16 17 18 Power Button Carry Handle Grounding Test Post USB Diagnostic Port On Off Switch Power Cord Connection USB Diagnostic Port is used for repairs and or maintenance issues and should only be used by a certified technician 25 Operating Instructions InTENSity Professional Series CX4 EX4 OPERATOR CONTROLS INTENSITY CX4 SEE E E eS mak imd qus axo uuo x ck j o 0c c5nDn oO Channel 4 Lead Wire Connections Ultrasound Therapy Button Combination Therapy button Ultrasound Indicator Light 5 cm Ultrasound Head Ultrasound Head Cradle Ultrasound Head Connection gt RLS 977 Power LED Indicator Touch Screen
16. 4 EX4 Treatment Time Adjustment Touch the timer The color will change to orange Adjust the treatment time with the central control dial AOS CC CV cc F ee Yo VY eet CH2 Start Therapy Once your parameters and timers oe are set start the therapy by touching the output intensity on the bottom of the screen The color will change to orange Use the central control dial to adjus the output level NOTE The current intensity can only be adjusted after the timer has been set To pause the treatment touch the pause button BN in the navigation bar To continue the treatment touch the run button E3 in the navigation bar To stop the treatment touch the STOP button E in the navigation bar NOTE To restart after pressing stop you will need to re enter the treatment time first Storing Your Favorite Settings When a treatment screen is completely set as required you can save those settings as a Favorite for later use As long as the treatment has not been started a store button will be available on the navigation bar To store your settings to Favorites touch the store button Enter the name of your favorite using the keyboard Press we to store your favorite under the name just entered NOTE Once saved favorites can be retrieved from the Electrotherapy Ultrasound and Combination menus NOTE 4 polar treatments are automatically saved and l
17. 60 Hz magnetic field to IEC 61000 4 8 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 seconds 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 80 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 seconds Power outlet quality should be that of a typical commercial or hospital environment Power outlet quality should be that of a typical commercial or hospital environment If the use of the InTENSity Professional Series device requires continued operation during power outlet interruptions it is recommended to install a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level Only install batteries that are recommended by the manufacturer zB InTENSity Professional Series CX4 EX4 The main features of the InTENSity Professional Series devices are as follows interference free delivery of shockwaves interference free control of all functions Uninterrupted operation is not required with the use intended Guidelines and Manufacturer s Declaration Electromagnet
18. 9 Waveform Specifications NMS NMS is a symmetrical biphasic waveform with a 120 us interphase interval Because the pulse is relatively short it is suitable for applications requiring high intensities such as in muscle strengthening protocols Parameters Frequency Phase Duration Cycle Time 20 In a pulsed current the Frequency refers to the number of pulses that occur in a one second period of time and is denoted in Hz or Pulses Per Second pps Expressed in us is the time it takes to complete one phase of a pulse The length affects the type of nerve recruited Cycle time refers to the time that the current is on and off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp time is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a timed on cycle InTENSity Professional Series CX4 EX4 Stimulator Output Parameters Mode selection CC Constant Current or CV Constant Voltage Intensity CC 0 200mA Stepping 0 5mA CV 0 200V Stepping 0 5V Phase Duration 20us 400us Stepping 20us Interphase Interval 120yus Cycle Time Continuous 10 10 10 20 10 30 10 50 Custom Treatment Time 1 60 Minutes InTENSity Professional Series CX4 EX4 ULTRASOUND THERAPY Parameters Ultrasound Frequency Expressed in MHz it is the frequency of the
19. Displ fail t Check the following contacts se of controls or adjustments or performance of procedures other Isplays fall to All contacts are in place than those specified herein may result in hazardous exposure to light up e All contacts are not broken ultrasonic energy e Ensure that adapter is connected TECHNICAL MAINTENANCE Electrodes 1 Replace 1 Dried out or contaminated 2 Electrodes must be a minimum of Stimulation weak 2 Placement 1 5 inches apart e This unit operates with high voltages No attempt should be made to sys ips disassemble the unit Maintenance and repair should be carried out by DUET authorized personnel only The manufacturer will not be held responsible Reapply electrodes secure firmly for the results of maintenance or repairs by unauthorized persons Stimulation stops Damaged or worn electrodes Replace e All other technical maintenance is restricted to authorized manufacturer or lead wires maintenance personnel 49 Troubleshooting Intensity is too high Decrease intensity Electrodes are too close Reposition the electrodes Reposition the electrodes electrodes together g Electrodes must be a minimum of 1 5 inches apart Damaged or worn electrodes Replace or lead wires Stimulation is Uncomfortable Electrode active area size is too small Replace electrodes with ones that have an active area no less than 2 inches Improper electrode Reposition
20. InTENSity Professional Series USER MANUAL Operation Instructions For DQ7000 InTENSity EX4 Electrotherapy DOS8000 InTENSity CX4 Combination Electrotherapy amp Ultrasound AAN 5osco InTENSity CX4 EX4 InTENSity Professional Series CX4 EX4 THIS USER MANUAL IS VALID FOR THE INTENSITY CX4 amp EX4 PROFESSIONAL SERIES DEVICES This user manual is published by Roscoe Medical Inc Roscoe Medical Inc reserves the right to improve and amend it at any time without prior notice Amendments will however be published in a new edition of this manual All Rights Reserved 42 DQ8000 MAN 02 O 2015 Conformity to safety standards Roscoe Medical Inc declares that the InTENSity Professional Series comply with following normative documents IEC60601 1 IEC60601 1 2 IEC60601 2 10 IEC60601 2 5 ISO7010 IEC61689 15014971 I8010993 1 IS010993 5 I5010993 10 Complies with MDD 93 42 EEC and Amended by directive 2007 47 EC requirements InTENSity Professional Series CX4 EX4 Roscoe Medical TABLE OF CONTENTS doas s ones secre en 5 Safety Precautions And Warnings 5 10 Do Not Use With These Medical Devices 6 Do Not Use This Device Under These Conditions 6 Electrode Warnings ses se Eu rex RE eee se ANE ER Au ed E 7 General Warnings 2oceeii si uda ex ER Ev EITPRESET qaa 8 Electrothierapy WarningS s s E a xoed ies sce
21. M c e e 07 007 00 00 mA Use the central control dial to adjust the output level NOTE The current intensity can only be adjusted after the timer has been set InTENSity Professional Series CX4 EX4 6 Start Therapy cont e To pause the treatment touch the pause button E in the navigation bar e To continue the treatment touch the run button E3 in the navigation bar e o stop the treatment touch the STOP button Milf in the navigation bar e NOTE To restart after pressing stop you will need to re enter the treatment time first 7 Storing Your Favorite Settings e When a treatment screen is completely set as required you can save those settings as a favorite for later use e Aslong as the treatment has not been started a store button will be available on the navigation bar e To store your settings to Favorites touch the store button Enter the name of your favorite using the keyboard Press Gb to store your favorite under the name just entered NOTE Once saved Favorites can be retrieved from the Electrotherapy Ultrasound and Combination Menus NOTE 4 polar treatments are automatically saved and loaded as a dual channel treatment Navigation Please enter your favorite name MN Darg casae Once pars tuv wxyz Cap 0 Lock space 35 Navigation Electrotherapy Set Up Manual Operation 1 Manual Opera
22. NT OF ULTRASOUND If movement of the applicator is too slow the patient may feel periosteal pain characterized by a deep ache or pain If motion is too fast or if the applicator does not maintain good contact with the skin the therapeutic effect of the sound waves will be reduced and the applicator may overheat POTENTIAL ADVERSE EFFECTS OF ULTRASOUND e Cataracts e Male Sterility e Enhanced Drug Activity e Thermal Stress PATIENT SUSCEPTIBILITY Some patients are more sensitive to ultrasound output and may experience a reaction similar to a heat rash Be sure to inspect the treatment area during and following treatment and discontinue if an adverse reaction does occur COUPLING Coupling is described as contact between the applicator and the treatment site and may be accomplished through the use of a coupling agent such as gel or lotion Anything used as a coupling agent must be highly conductive Air is a very poor conductor of ultrasonic waves DO NOT use a conductive medium with an alcohol based content or that is not approved specifically for ultrasound conductivity Adverse Effects PARAMETER DEFINITIONS Em Frequency Modulation Frea Frequency AM AmpiudeModusion Dur Phase Duration Ramp RampTime M CTS Waveform Specifications ELECTROTHERAPY IF 4P IFC Interferential Traditional 4 Pole Interferential Current is a medium frequency wavefor
23. Sym Channel Mode Biphasic Single Frequency Phase Dur 50pps 300us ON OFF Time Continuos Electrode Output Indicator Channel 1 2 3 or 4 CC CV InTENSity Professional Series CX4 EX4 Product Description ULTRASOUND TREATMENT SCREEN 1 Remaining Treatment Time 2 Output Value 3 Unit of Output Value w cm EXIECHES IETRTTET Frequency 1MHz Continuous COMBINATION THERAPY SCREEN 1 Ultrasound Output Indicator Electrode Output Indicator Remaining Treatment Time lectrotherapy Output Value Unit of Output Value mA Ultrasound Output Value 2 3 E 4 5 6 7 Unit of Output Value w cm CT2200 EXE NE Manual Burst Freq Duty Cycle 50bps 50 Carrier Freq 2500Hz CC CV sf Application Information ELECTROTHERAPY e Connection of accessories other than the ones specified by the manufacturer can adversely affect the safety of the patient and correct functioning of the equipment and is therefore not permitted e To prevent infection electrodes should not be used on broken skin Before Treatment e Check the patient for contraindications and warnings as described on page 11 e Test the heat sensitivity of the treatment area e Clean the treatment area Any areas with excess hair should be clipped or shaved to ensure good conductivity Flexible Rubber Electrodes We recommend using the flexible rubber elec
24. Therapy Set Up Manual Operation 3 Setting Electrotherapy Parameters e The first parameter screen that is shown EIE PLEASE NOTE Combination Therapy combines ultrasound amp electrotherapy through the sound head In order for combination therapy to be active you MUST use the dark green combination lead wire plugged into channel 2 receptacle All other lead wires should be unplugged To ensure efficient transfer of energy a contact medium is required between the ultrasound applicator and the body The best medium for the transfer of ultrasound energy is a gel b dai wd 2 Ultrasound 1 Home e The Home Menu gives access to all functions of the unit e Select the Combination button 22 Combination i i3 System Settings 2 Manual Operation e The Combination Menu provides access to the following functions 1 Favorites 2 Manual Operation Combination Favorites RT Manual Operation e Select Manual Operation button Treatment Time and EIE is for electrotherapy parameters Select the desired electrotherapy waveform by pressing the button Current Waveform n Biphasic WW Premod 4 High Volt NOTE Some selections have more options to choose from and on the next screen another list appears from which the current waveform can be selected ar NMS Parameter Adjustment I gt utaseund CV Touch the timer The color will change to orange Adjust
25. adiation Area Beam Type for 1 cm amp 5 cm Applicators BNR Beam Non Uniformity 5 1 Maximum Ratio 1 cm 1096 294 Ultrasound Specifications ULTRASOUND THERAPY cont Parameter Limit For security the device has some limitations for electrotherapy The maximum intensity has a relationship with the frequency and pulse duration following below table Pulse Frequency Phase Duration Max Current Output 100 250 lt 500us 100mA Technical Data Power Supply 100V 240V 50 Hz 60 Hz 1A 15V 4A Max 10 x 7 x 5 LxWxH Power Output Dimensions Operating Environmental Temperature 10 C 14 F to 55 C 131 F 1096 90 700hPa 1 060hPa Relative Humidity Atmosphere Pressure 2050 InTENSity Professional Series CX4 EX4 Transportation and Storage Environment 20 C 4 F t0 55 C 0131F Relative Humidity 20 90 Atmosphere Pressure 700hPa 1 060hPa CONNECTION TO AC POWER Insert the power cable into the socket on the back of the device and plug it into a grounded wall outlet e Do not place the device in a location where the power cord could be tripped over or pulled out during treatment e Do not attempt to use the device if it is not properly grounded Make certain that the device is electrically grounded by connecting it only to a grounded electrical service receptacle conformable with the applicable national and local electrical codes regarding medical en
26. ave more options to choose from and on the next screen another list appears from which to choose from 4 Treatment Time Adjustment e Touch the timer The color will change to orange Adjust the treatment time with the central control dial 40 Manual Frequency 1MHz Continuous InTENSity Professional Series CX4 EX4 To ensure efficient transfer of energy a contact medium is required between the ultrasound applicator and the body The best medium for the transfer of ultrasound energy is a gel 5 Start Therapy e Once your parameters and timer are set make contact with the treatment area Then start the therapy by touching the output intensity on the bottom of the screen The color will change to orange e Use the central control dial to adjust the output level e Note The current intensity can only be adjusted after the timer has been set The count down starts when contact is activated e To pause the treatment touch the pause button BN in the navigation bar e To continue the treatment touch the run button E3 in the navigation bar e To stop the treatment touch the STOP button E in the navigation bar Le Jia Le Manual Frequency 1MHz T Continuous e NOTE To restart after pressing stop you will need to re enter the treatment time first InTENSity Professional Series CX4 EX4 Ultrasound Therapy Set Up Clin
27. cessary the equipment should be observed to verify normal operation in the configuration in which it will be used GENERAL PRECAUTIONS e The long term effects of electrical stimulation are unknown e Apply stimulation to only normal intact clean dry and healthy skin e Electrotherapy is not effective in treating the original source or cause of the pain including headache e Electrotherapy is not a substitute for pain medications and other pain management therapies e Electrotherapy devices do not cure disease or injuries e Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain e Patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel e f patients have suspected or diagnosed epilepsy proceed with caution e Use caution if patient has a tendency to bleed internally such as following an injury or fracture e Using the device after a recent surgical procedure may disrupt the healing process e Use caution if stimulation is applied over areas of skin that lack normal sensation InTENSity Professional Series CX4 EX4 GENERAL PRECAUTIONS e Keep unit out of the reach of young children The unit contains small pieces that may be swallowed The electrode cord can cause strangulation Immediately DIAL 911 should any of these things occur e Use this device only with the leads electrodes and ac
28. cessories recommended by the manufacturer e f a patient is injured during treatment discontinue use immediately and contact your dealer about the injury InTENSity Professional Series CX4 EX4 Intended Use ELECTROTHERAPY INDICATIONS amp CONTRAINDICATIONS CONTRAINDICATIONS Indications for TENS EMS NMS NMS Burst Russian RUSS e his device should not be used for symptomatic pain relief i i i unless etiology is established or unless a pain syndrome has been diagnosed This device should not be used on patients with demand type cardiac pacemakers This device should not be used over cancerous lesions Electrode placements that apply current to the carotid sinus region anterior neck must be avoided Electrode placements that apply current transcerebrally through the head must be avoided Electrode placements that apply current transthoracically the introduction of electrical current into the heart may cause cardiac arrhythmias must be avoided Stimulation should not be applied over swollen infected inflamed area or skin eruptions e g phlebitis thrombophlebitis varicose veins etc 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 Safety has not been established for the use of therapeutic electrical stimulation during pregnancy High Voltage Pulsed Current HVPC Interfe
29. dical devices may cause erroneous operation of those devices Do not use other RF equipment near the InTENSity Professional Series Do not use RFID systems near the InTENSity Professional Series Do not use electrical stimulation in conjunction with high frequency surgical equipment or microwave or shortwave therapy systems This device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided on pages 51 53 These devices are contraindicated for use in an MRI environment and should be removed prior to an MRI exam or MHI exposure Keep the device away from strong magnetic fields These devices are MR unsafe InTENSity Professional Series CX4 EX4 DO NOT USE THIS DEVICE UNDER THESE CONDITIONS e f a patient has a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device Such use could cause electric shock burns electrical interference or death e Together with a life supporting medical electronic device such as an artificial heart or lung or respirator e In the presence of electronic monitoring equipment e g cardiac monitors ECG alarms which may not operate properly when the electrical stimulation device is in use e On open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins or on top of or in proximity to cancerous lesio
30. e Gods ae 42 Treatment Time Adjustment TM 42 Warranty TV 54 SIL MMO ese soso fe id AUR Ec on Ss Sot rai abo Maz ACE ae 42 i METTE 54 55 Combination Therapy Set Up Manual Operation 43 Parameters Electrotherapy ssn 43 Treatment amp Parameter Adjustment 43 Parameters Ultrasound 000 cece eee 44 Treatment Time Adjustment 00000 eee ee 44 Storing Favorites a x as ded weak nee Be eo dw as 44 InTENSity Professional Series CX4 EX4 Forward INTENDED USER OPERATOR IMPORTANT SAFETY PRECAUTIONS This manual has been written for the users of the InTENSity Professional Series CX4 and EX4 medical devices It contains AND WARNINGS general information on the operation precautionary practices and maintenance information In order to maximize its use efficiency It is important that you read all the warnings and and the life of the system please read this manual thoroughly and precautions included in this manual because they become familiar with the controls as well as the accessories before are intended to keep the patient safe prevent injury operating the system and avoid a situation that could result in damage to the device These devices are designed to only be used by or under the supervision of persons using the medical device in the course of their work and in the framework of a professional healthcare activity who understand the benefits and lim
31. e the applicator If the body surface is very irregular making it difficult to obtain good contact between the ultrasound applicator and the body or if direct contact must be avoided e g due to pain the affected area may be treated under water subaqual method The water should be degassed by previous boiling in order to prevent air bubbles arising on the ultrasound applicator and the body EE InTENSity Professional Series CX4 EX4 Before Treatment Check the patient for contraindications See page 12 for details Test the warmth sensitivity of the treatment area To optimize ultrasound transmission clean the skin of the treatment area with soap or a 7096 alcohol solution Any areas with excess hair should be clipped or shaved to ensure good conductivity During Treatment The ultrasound applicator has to be moved constantly with the semi static method During treatment the displayed ultrasound amplitude can vary around the set value caused by fluctuations in acoustical coupling Ask the patient regularly for his her findings If necessary the treatment will have to be adapted The amplitude can be reduced or the continuous mode can be changed to pulsed mode or vice versa When there are signs that the ultrasound transmission is bad add more contact gel or spread it with the applicator After Treatment Clean the skin of the patient and the ultrasound applicator with a towel or tissue Clean the applicato
32. eas 3 On patients with hemorrhagic diathesis e Ultrasound should be routinely checked before each use to determine that all controls function normally Especially if the intensity control does properly adjust the ultrasonic power output in a stable manner Also determine that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero e Use the ultrasound applicator with care Inappropriate handling of the ultrasound applicator may adversely affect its characteristics e Before each use inspect the ultrasound applicator for cracks which may allow conductive fluid to seep through e Ultrasound therapy is not designed to be water tight Entrance of water or liquid could cause malfunction of internal components and therefore create risk of severe injury to the patient e Any bleeding tendency is increased by heating because of the increase in blood flow and vascularity of the heated tissues Care therefore should be used in treating patients with therapeutic ultrasound who have hemorrhagic diathesis or bleeding disorders e Do not use a conductive medium with an alcohol based content Safety Precautions CAUTION WHILE USING THE STIMULATOR e f the stimulator is not functioning properly or the patient feels discomfort immediately stop using the device e Do not use for any other purpose except for what it is intended for e Do not pull on the electrodes or lead wires during treatment e Pa
33. efore administering any treatment to a patient you should become acquainted with the operating procedures 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 and ultrasound e To prevent electrical shock disconnect the unit from the power source before attempting any maintenance procedures e The use of accessories transducers and cables than those specified with the exception of transducers and cables sold by the manufacturer as replacement parts for internal components may result in increased emissions or decreased immunity of the device e Make certain there are no cracks or damage to any wires attached to the device InTENSity Professional Series CX4 EX4 WARNING cont ELECTROTHERAPY WARNINGS e TENS therapy has not been established for pain of central origin e This device is to be used as a symptomatic treatment for pain and has no curative value Patients should be cautioned and their activities regulated if pain that would otherwise serve as a protective mechanism is suppressed e The long term effects of chronic electrical stimulation are unknown e Safety has not been established for the use of therapeutic electrical stimulation during pregnancy e Stimulation should not be applied over swollen infected or inflamed areas of skin eruptions e g phlebitis thromb
34. ic Interference Immunity The InTENSity Professional Series device is intended for operation in the electromagnetic environment specified below The customer or user of the InTENSity Professional Series should ensure that it is used in such an environment Interference IEC 60601 Test Compliance Electromagnetic Immunity Tests Level Level Environment Guidelines Conducted RF 3V effective 3V effective Portable and mobile radio disturbance value 150 kHz value 150 kHz should not be used any variables according to 80MHz to 80MHz closer to the InTENSity to IEC 61000 4 6 3 V m 3 V m Professional Series devices Radiated RF 80 MHz to 80 MHz to including cables than the disturbance 2 5GHz 2 5GHz recommended separation variables distance calculated from the according to equation applicable to the IEC 61000 4 3 transmission frequency Recommended Separation Distance d 1 2 JP d 0 35 JP for 80 MHz to 800 MHz d 0 7 JP for 800 MHz to 2 5 GHz Where P is the rated power of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m The field strength of stationary radio transmitters should be less than the compliance level at all frequencies Interference may occur in the vicinity of INTENSity Professional Series devices Cte which is marked with the following symbol A NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable NOTE 2 These guidelines may not be applicable
35. ical Protocols cont 6 Storing Your Favorite Settings When a treatment screen is completely set as required you can save those settings as a favorite for later use As long as the treatment has not been started a store button will be available on the navigation bar To store your settings to Favorites touch the store button Enter the name of your favorite using the keyboard Press wh to store your favorite under the name just entered NOTE Once saved favorites can be retrieved from the Electrotherapy Ultrasound and Combination menus 4 polar treatments are automatically saved and loaded as a dual channel treatments C2 Please enter your favorite name DARHA e IS ee oo 7 9 Prine pqrs WXYZ Cap Navigation Ultrasound Therapy Set Up Manual Operation 1 Home e The Home Menu gives access to all functions of the unit e Select the Ultrasound button 2 Manual Operation e The Ultrasound menu provides access to the following functions 1 Clinical Protocols 2 Favorites 3 Manual Operation e Select Manual Operation button ve Manual Operation HOME Y Electrotherapy 2 Ultrasound Le JL Ultrasound Clinical Protocols Favorites zd Navigation 3 Parameters e Adjust the parameters by touching the desired parameter button and change the value with the central control dial e NOTE Some parameters have mo
36. imum distance between portable and mobile HF telecommunications 4 series transmitters and the InTENSity Professional Series device according to the output power of the communications device as indicated in the following table EMC Table Rated Output of Separation Distance According to Frequency of Transmitter m Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 JP d 0 35 JP d 0 7 JP 0 07 0 22 0 70 2 2 For transmitters rated at a maximum output which is not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the respective column whereby P is the maximum rated output of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable NOTE 2 These guidelines may not be applicable in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people zB Warranty WARRANTY Please contact your dealer or the device center in case of a claim under the warranty If you have to send in the unit enclose a copy of your receipt and state what the defect is The following warranty terms apply 1 The warranty period for this InTENSity Professional Series device is three years from date of purchase In case of a warranty claim the date of purchase has to be proven by means of the sales receipt or invoice
37. itations of electrotherapy and ultrasound therapy SAFETY SYMBOLS USED IN THIS MANUAL Indicates a potentially hazardous situation which if not avoided could result in death or serious injury WARNING USA ONLY U S A Federal Law restricts these devices to sale by or on the order of a physician or licensed practitioner This device should be used only under the continued supervision of a physician or licensed practitioner if not avoided could result in serious injury and A waa Indicates a potentially hazardous situation which equipment damage Indicates a potentially hazardous situation which l l if not avoided may result in minor or moderate injury These devices have been thoroughly tested and inspected to assure to the user or patient or damage to the device or proper performance and operation other property Specifications put forth in this manual were in effect at the time of publication However to ensure continual improvement measures changes to these specifications may be made at any time without obligation on the part of manufacturer Safety Precautions THIS STIMULATOR MUST NOT BE USED IN COMBINATION WITH THE FOLLOWING MEDICAL DEVICES 1 Internally transplanted electronic medical devices such as a pacemaker 2 Electronic life support equipment such as respirators 3 Electronic medical devices attached to the body such as electrocardiographs Using this stimulator with other electronic me
38. ls The electrotherapy channels can be used in combination linked or totally independent A comprehensive set of current waveforms to include TENS EMS IF Russian High Volt and Microcurrent are available targeting both pain management and muscle stimulation applications Protocols can run on linked or independent channels With independent channels two or four different protocols can be performed simultaneously INTENSITY CX4 The InTENSity CX4 is a combination device combining the functions of the InTENSity EX4 and the Ultrasound Therapy in a single device With the InTENSity CX4 the simultaneous application of ultrasound and electrotherapy combination therapy is also possible The remaining electrotherapy channel can then be used independently 28 InTENSity Professional Series CX4 EX4 InTENSity Professional Series CX4 EX4 HOME SCREEN DISPLAY When you turn on the unit you will first enter the Home Menu In the Home Menu none of the channels are selected The Home Menu provides structured access to all therapies available within the unit with appropriate parameter defaults Just select a menu item by touching the button to navigate to the next screen You can navigate back to the previous screen by touching the back arrow at the top of the screen Anywhere in the navigation you can jump back to the Home Menu by touching the home button EJ InTENSity EX4 InTENSity CX4 Intensity EX4 Intensity CX4 HOME
39. m 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 and decreases at a regular frequency PARAMETERS Carrier Frequency Beat Frequency High amp Low Vector Auto Vector Manual Carrier frequency is the base frequency of the alternating current Occurs when two waveforms are in and out of phases The difference between the two frequencies produces the modulated effect i e Beat H of 4000 and Beat L of 4150 will yield a 150 pps beat frequency Vector Auto is a form of amplitude modulation and is a percentage of the set interferential amplitude intensity and will decrease from its maximum level over 6 seconds Vector Manual is a form of amplitude modulation When Vector Manual is set to a different angle the output intensities of two channels are different The rhythmical change in position of the interference pattern results in the modulation of the amplitude of one or both input currents InTENSity Professional Series CX4 EX4 Stimulator Output Parameters CC Constant Current or CV Constant Voltage Vector Scan Auto 2096 10096 Stepping 2096 Manual 0 90 Stepping 15 Carrier Frequency 2 10 KHz Stepping 0 5 KHz Beat High Beat L 200 Hz Stepping 1Hz 1
40. m disturbances which could be lethal WARNINGS AND PRECAUTIONS REGARDING THE ELECTRODES e Apply electrodes to normal healthy dry clean skin of adult patients because it may otherwise disrupt the healing process e f the patient experiences any skin irritation or redness after a session do not continue stimulation in that area of the skin Do not bend or fold the electrode because it may not function properly Place the self adhesive electrodes onto the plastic film and then store into the sealed package when not in use e Do not apply ointment or any solvent to the electrodes or to the patient s skin because it will disrupt the electrodes from functioning properly Safety Precautions A WARNING cont e The electrodes are already pre gelled and will adhere to clean skin e To avoid damage to the adhesive surface of the electrodes put them only on the skin or on the plastic film provided e Make sure the components are connected well and the electrodes are fixed on the part of the body you wish to treat or the therapy may not be effective DO NOT USE ELECTRODES THIS WAY e Self adhesive electrodes are for single patient used only Do not use electrodes on several different patients to avoid transferring any contamination e Electrodes should not touch each other when placed onto patient s skin Keep them at least 1 apart during treatment Electrodes too close together or touching could result in improper stimulatio
41. n or skin burns e Do not place on patient s spine or backbone e Electrodes should not touch any metal object such as a belt buckle or necklace e Electrodes should not be placed simultaneously on the soles of both feet e Electrodes should not be placed simultaneously on the calves of both legs e Do not place or relocate the electrodes while the device is on e Always turn the power off before removing or changing the electrode location e Do not leave electrodes attached to the skin after treatment e Do not lean against or lay on electrodes while administering electrotherapy as this could cause an increase in stimulation Safety Precautions WARNING cont GENERAL WARNINGS e Make certain the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes e To avoid the risk of electric shock this equipment must only be connected to a grounded outlet e The InTENSity Professional Series devices are not suitable for use in the presence of flammable anesthetics mixture with air oxygen or nitrous oxide e hese devices should be kept out of the reach of children e Care must be taken when operating this equipment around other equipment Potential electromagnetic or other interference could occur to this or to the other equipment Try to minimize this interference by not using other equipment in conjunction with it e B
42. nder the name just entered NOTE Once saved favorites can be retrieved from the Electrotherapy Ultrasound and Combination menus NOTE 4 polar treatments are automatically saved and loaded as a dual channel treatment InTENSity Professional Series CX4 EX4 C2 Please enter your favorite name E Lock space InTENSity Professional Series CX4 EX4 System Settings 1 Home Screen e From the Home Menu choose System Settings to access to all the functions of the unit HOME Y Electrotherapy 2 Ultrasound e NOTE You can reach this menu at an time by pressing the Home button al Combination A System Settings 2 Settings Adjustment e Here you can personalize the unit Several settings can be changed or adjusted by touching the desired option and using the central control dial to navigate through the options rer am Setting LCD Brightness e Touch the back arrow or Home button to return to the Home Menu Speaker Volume 0 End of Treatment Sound Operating Details Adjusting Current Amplitude The unity of the displayed current amplitude depends on the previously selected current waveform and can be expressed in mA pA or V by pressing the CC CV button CC CV Mode Depending on the selected current waveform the electrotherapy channels can be used in the Constant Current or Constant Voltage mode In CV mode the output cur
43. ns e Over areas of skin that lack normal sensation e Do not use while patient is in bath or shower e Do not use while patient is sleeping e Patients with arterial or venous thrombosis or thrombophlebitis are at risk of developing embolisms when electrical stimulation is applied over or adjacent to the vessels containing the thrombus If a patient has a history of deep vein thrombosis even many years past the affected area should not be stimulated e Fresh fractures should not be stimulated in order to avoid unwanted motion e Stimulation should not be applied immediately following trauma or to tissues susceptible to hemorrhage InTENSity Professional Series CX4 EX4 DO NOT USE ON THESE INDIVIDUALS e Pregnant women because the safety of electrical stimulation during pregnancy has not been established e Children or infants because the device has not been evaluated for pediatric use e Persons incapable of expressing their thoughts or intentions NEVER APPLY THE ELECTRODES TO e The head or any area of the face The effects of stimulation of the brain are unknown e Any area of the throat because this could cause severe muscle spasms resulting in closure of the airway difficulty in breathing or adverse effects on heart rhythm or blood pressure e Both sides of the thorax simultaneously lateral or front and CN back or across the patient s chest because the introduction N of electrical current may cause rhyth
44. oaded as a dual channel treatment Navigation Please enter your favorite name DAHA e C Ile Cap 0 Lock BUSI z397 Ultrasound Application Ultrasound Therapy Application Contact Control The ultrasound applicator has a contact control function that suspends treatment when the acoustical contact with the body drops below a certain level The indicator light on the applicator will turn on to signal this situation while the ultrasound amplitude display will start blinking and the treatment timer will stop counting down During this situation the applicator emits a small amount of energy to sense restoration of acoustical contact You may experience this when the applicator only partially contacts the body When contact restoration is sensed the treatment is resumed at the set amplitude The contact control function does not work at amplitudes below 0 2 Watt cm The Contact Medium To ensure efficient transfer of energy a contact medium is required between the ultrasound applicator and the body Air causes virtually total reflection of the ultrasound energy The best medium for the transfer of ultrasound energy is a gel e The gel should be applied to the part of the body to be treated and then spread out with the ultrasound applicator e Never apply the gel to the ultrasound applicator The applicator will register this as acoustical contact and may emit ultrasound energy which could damag
45. ophlebitis varicose veins etc ULTRASOUND WARNINGS e Precaution should be taken when using therapeutic ultrasound on patients with hemorrhagic diathesis e Ultrasound treatment presents a potential safety hazard in patients whose pain response has been decreased because of disease previous surgery ionizing radiation therapy chemotherapy general or regional anesthesia It may cause burns Do not use on insensitive areas or in the presence of poor circulation e Large thermal doses may result in regions of thermal aseptic necrosis which may not be apparent on inspection of the skin e Patients who have cardiac pacemakers should be protected from direct ultrasound exposure over the thorax to protect the lead wires and pacemaker from such exposure e f a patient complains of periosteal pain deep achy pain during ultrasonic treatment intensity should be reduced to a comfortable level InTENSity Professional Series CX4 EX4 WARNING cont ULTRASOUND WARNINGS CONT e Moving technique of the applicator should be used when applying therapeutic ultrasound at intensities greater than 0 5 W cm to assure even exposure of tissues to ultrasound e Heating of the joint capsule in acute or subacute arthritis should be avoided e Additional precautions should be used when ultrasound is used on patients with the following conditions 1 Laminectomy i e when major covering tissues have been removed 2 Over anesthetic ar
46. or use in all establishments other than are subject to special precautions with regard to electromagnetic Harmonic emissions eer E E iaieg an eerie compatibility EMC and must be installed and commissioned in sala to a low voltage power supply network accordance with the EMC advice given in the instructions for use and Voltage fluctuation nde a which oin buildings used for and flicker according to IE onforms omestic purposes accompanying documents P CODE Portable and mobile RF communication systems e g mobile phones may cause interference with the InTENSity Professional Series The device should not be used when placed immediately next to or stacked on top of other devices If operation is necessary when immediately next to or stacked on top of other devices the device should be monitored to ensure it is operating as intended in this arrangement The InTENSity Professional Series should only be operated with the original power cord specified in the list of contents delivered Operating the device with any other power cord can lead to increased emissions or reduced interference immunity of the device Guidance And Manufacturer s Declaration Electromagnetic Immunity The InTENSity Professional Series device is intended for use in the electromagnetic environment specified below The customer or the user of the INTENSity Professional Series device should assure that it is used in such an environment The InTENSity Profes
47. r with a 7096 alcohol solution Check for the effects that can be expected for example pain circulation and mobility Ask the patient to inform the therapist of any reactions InTENSity Professional Series CX4 EX4 Navigation Ultrasound Therapy Set Up Clinical Protocols 1 Home 2 Clinical Protocols cont e Use the central control dial to scroll through the pages then select E the desired clinical protocol button vider fgiiueiue Yf Electrotherapy e For more information about the ni p o clinical protocol press the Tendon Ligament Ultrasound button next to the desired protocol Superficial uscle Deep Tendon Ligament Deep e The Home Menu gives access to all functions of the unit ec e Select the Ultrasound button EE 2 Clinical Protocols e The Ultrasound Menu gives you access to the following functions Teide 1 Clinical Protocols 2 Favorites Clinical Protocols 3 Manual Operation e Use the central control dial to scroll e Select Clinical Protocols button through the information mpm ae Manual Superficial Rationale 3 3 MHz ultrasound targets tissue less than or equal to 2 cm deep 39 Navigation Ultrasound Therapy Set Up Clinical Protocols cont 3 Parameters e Adjust the parameters by touching the desired parameter button and change the value with the central control dial e NOTE Some parameters h
48. re options to choose from and on the next screen another list appears from which to choose from 4 Treatment Time Adjustment e Touch the timer The color will change to orange Adjust the treatment time with the central control dial 42 Lejla Le Manual Frequency 1MHz mcm Continuous Wicm2 InTENSity Professional Series CX4 EX4 To ensure efficient transfer of energy a contact medium is required between the ultrasound applicator and the body The best medium for the transfer of ultrasound energy is a gel 5 Start Therapy Once your parameters and timer are set make contact with the treatment area Then start the therapy by touching the output intensity on the bottom of the screen The color will change to orange Use the central control dial to adjust the output level NOTE The current intensity can only be adjusted after the timer has been set The count down starts when contact is activated To pause the treatment touch the pause button BN in the navigation bar To continue the treatment touch the run button E3 in the navigation bar To stop the treatment touch the STOP button E in the navigation bar Le Jie le Manual Frequency 1MHz T Continuous NOTE To restart after pressing stop you will need to re enter the treatment time first InTENSity Professional Series CX4 EX4 Navigation Combination
49. rent depends on the electrical contact with the patient and can therefore vary You can change the CC CV setting in the parameter menu Current Polarity When monophasic currents are used the red connection is the positive connection and the black is the negative connection 45 Maintenance Cleaning Cleaning of the Device e Switch off the device and disconnect it from the power supply e The device can be cleaned with a damp cloth e Use lukewarm water and a non abrasive liquid household cleaner non abrasive non alcohol content solution e fa more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner Do not submerse the device in liquids Should the unit accidentally become submersed contact the dealer or authorized service center immediately Do not attempt to use a system that has been wet inside until inspected and tested by a certified service technician Do not allow liquids to enter the ventilation holes 46 InTENSity Professional Series CX4 EX4 Cleaning of Display Panel Use a soft and dry cotton or micro fiber cloth to clean the panel To remove fingerprints or grease use a non abrasive glass cleaning agent Apply a small amount of the cleaning agent to a soft cotton cloth and carefully clean the panel e Do not spray the cleaning agent directly on the glass panel e Do not use cleaning agents that contain strong alkali lye acid detergents with fluoride
50. rential Pre modulated Interferential and Microcurrent waveforms e Pain relief of chronic intractable pain e Pain associated with post traumatic or postoperative conditions Helaxation of muscle spasms Prevention or retardation of disuse atrophy Increase local blood circulation Muscle re education Maintaining or increasing range of motion Dysphagia Immediate post surgical stimulation of calf muscles to prevent venous thrombosis do not stimulate calf muscle simultaneously Eie Intended Use ULTRASOUND INDICATIONS amp CONTRAINDICATIONS INDICATIONS FOR ULTRASOUND e Relief of pain muscle spasms and joint contractures that may be associated with Adhesive capsulitis Epicondylitis Bursitis with slight calcification Myositis Soft tissue injuries Shortened tendons due to past injuries and scar tissues Ligament sprains Relief of sub chronic chronic pain and joint contractures resulting from 1 Capsular tightness 2 Capsular scarring NOOR WN A CONTRAINDICATIONS The established contraindications to heat therapy itself for example 245 In an area of the body where a malignancy is known to be present Over or near bone growth centers until bone growth is complete Over the thoracic area at all This device should not be used over a healing fracture In the presence of metal implants of any type Patients with sensory loss on the area to be treated InTENSity Professional Series CX4 EX4 Therapeutic
51. seconds and resting for 50 seconds Ramp is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a timed on cycle NOTE When administering High Volt Therapy whether in combination or only electrotherapy stim you should use the large dispersive electrode measuring 3 x 5 at the least This will reduce adverse reactions to the skin as well as evenly distribute the stimulation 249 InTENSity Professional Series CX4 EX4 Waveform Specifications MICROCURRENT Stimulator Output Parameters Microcurrent isa MONOPAASIE waveform of very low intensity which 0 1 1 000 Hz Stepping 0 1 Hz 1 Hz replicats the body s use of natural frequencies when repairing or growing its new cells It creates a physiological electric modality Polarity Positive Negative Alternating that increases ATP energy production in the cells of your body CC 0 1 000pA Stepping 5yA The physiological working mechanism of this effect is not clearly understood yet but has previously been shown to help with ow Hine 19 MIMIeS reduction in healing time Cycle Fixed Ramp Fixed Parameters Frequency In a pulsed current the Frequency refers to the number of pulses that occur in a one second period of time and is denoted in Hz or Pulses Per Second pps Polarity This refers to the polarity of the red lead wire connect the lead wire to the active electrode 1
52. sional Seri Vice is inten for ration in an electromagnetic S y er al Series device is intended for operatio pees g Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment as indicated below The customer or user of the InTENSity Professional Series inj Environment Guidance unit should ensure that it is operated in such an environment Floors should be Interference Tests Conformity Electromagnetic Environment Guideline wood concrete or The InTENSity Professional Series Electrostatic id Bonita iG RU contaci ceramic tile If floors are device uses HF energy solely for its discharge ESD B 8 kV air E 8 kV air covered with synthetic internal functioning Its RF emission is to IEC 61000 4 2 z material the relative therefore very low and it is unlikely that humidity should be at this will cause interference to least 30 neighboring electronic InTENSity Professional Series Electrical fast tran sient burst to IEC 61000 4 4 Guidelines And Manufacturer s Declaration Electromagnetic Interference HF emissions according to CISPR 11 x 2 kV for power supply lines 1 KV for input output lines Power Outlet quality should be that of a typical commercial or hospital environment x 2 kV for power supply lines not applicable Mu EMC Table Surge IEC 6100 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50
53. tepping 0 5mA CV 0 200V Stepping 0 5V final frequency will vary from 80 120 Hz Amplitude Modulation Amplitude Modulation is rhythmical Phase Duration 20us 1 000ys Stepping 5ps Frequency In a pulsed current the Frequency refers to fluctuation of the intensity to prevent Frequency 1 250 Hz Stepping 1 Hz accommodation Cycle Time Continuous 10 10 10 20 10 30 10 50 Custom Treatment Time 1 60 Minutes 236 InTENSity Professional Series CX4 EX4 Waveform Specifications RUSSIAN STIMULATION Stimulator Output Parameters Russian Current is a medium frequency rectangle waveform Carrier Frequency 25KHz delivered in bursts or series of pulses This method was claimed eae ren SUME by its author Kots to produce maximal muscle strengthening 20 100 Hz Stepping 5 Hz effects without significant discomfort to the patient Duty cycle 1096 5096 Stepping 1096 Mode selection CC Constant Current or PARAMETERS CV Constant voltage Intensity CC 0 100mA Stepping 0 5mA CV 0 100V Stepping 0 5V Treatment Time 1 60 Minutes Cycle time Continuous 10 10 10 20 10 30 10 50 Custom Carrier Frequency Carrier frequency is the base frequency of the alternating current Frequency In a pulsed current the Frequency refers to the number of pulses that occur in a one second period of time and is denoted in Hz or Pulses Per Second pps Duty Duty is the percentage of the total treatment time
54. that the current is actually flowing Cycle Time Cycle time refers to the time that the current is On and Off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10 seconds and resting for 50 seconds Ramp is used to set a gradual increase in intensity during the on time Ramps occur at the beginning and ending of a cycle 247 Waveform Specifications InTENSity Professional Series CX4 EX4 HIGH VOLT Stimulator Output Parameters The High Volt waveform has a very brief pulse duration characterized Frequency 1 120HzSteppingiHz by 2 distinct peaks delivered at high voltage High voltage causes a iius riso l pe epee Ie decreased skin resistance making the current comfortable and easy Polarity Positive or Negative to tolerate A monophasic twin peaked waveform with a short phase 100ys duration and a long interpulse interval eliminates the formation of any appreciable chemical or thermal effects in the tissue ions eco UON OISDDIT ION PARAMETERS Frequency n a pulsed current the Frequency refers to the number of pulses that occur in a one second period of time and is denoted in Hz or Pulses Per Second pps Polarity This refers to the polarity of the red lead wire connect the lead wire to the active electrode Cycle Time Cycle Time refers to the time that the current is on and off in seconds Example for a Cycle Time of 10 50 the current will be flowing for 10
55. tients should remove all metal accessories i e necklace watch ring s etc prior to administering therapy as these items may cause damage to the device e Do not use near a cell phone as this may cause the stimulator to malfunction e Do not bend or pull the end of the cord e When pulling out the cord from the device hold the plug and pull e Replace the lead wires when broken or damaged e Dispose of the device batteries and components according to applicable legal regulations Unlawful disposal may cause environmental pollution e The size shape and type of electrodes may affect the safety and effectiveness of electrical stimulation Please read instructions for which electrodes should be used specifically for combination therapy and High Volt e The electrical performance characteristics of electrodes may affect the safety and effectiveness of electrical stimulation e Using electrodes that are too small or incorrectly applied could result in discomfort or skin burns e Keep yourself informed of the contraindications e DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner Safety Precautions CAUTION WHILE USING THE STIMULATOR CONT e Inspect applicator cables and associated connectors before each use e his device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is ne
56. tion The electrotherapy menu provides access to the following functions 1 Clinical Protocols 2 Favorites 3 Manual Operation Select Manual Operation Waveform Selection Select the desired current waveform NOTE Some selections have more options to choose from and on the next screen another list appears from which to choose from 36 E3ECI Electrotherapy Bl Clinical Protocols Favorites p Manual Operation KAK Current Waveform n Biphasic WW Premod AMA High von EX IFC 4P NMS HH Russian TE Micro Current InTENSity Professional Series CX4 EX4 Channel Selection Select the channels for electrotherapy When channel 1 is selected channels 2 3 and 4 are still available for another therapy When channels 1 2 or 3 4 are selected both channels have the same parameters Only the intensity can be set differently Parameters Adjust the parameters by touching the desired parameter button and change the value with the central control dial NOTE Some parameters have more options to choose from and on the next screen another list appears from which to choose from Touch the button if you want to switch to parameters of channels 3 amp 4 BEE Chronic Pain 2 Electrodes noe Channel Mode JI Biphasic Single Frequency Phase Dur 50pps 300us ON OFF Time Continuos CC CV cc InTENSity Professional Series CX
57. tment Time 1 60 Minutes 335 Waveform Specifications InTENSity Professional Series CX4 EX4 BIPHASIC TENS Stimulator Output Parameters The Asymmetrical Biphasic and the Symmetrical Biphasic waveforms TENS Asymmetrical Biphasic are often used in TENS Transcutaneous Electrical Nerve Stimulation An Output Mode Electrodes applications TENS is low frequency waveform and has a short pulse duration The Alternating Rectangular waveform is an interrupted Mode selection CC Constant Current or CV Constant voltage biphasic current with a rectangular pulse shape This waveform is Intensity CC 0 200mA Stepping 0 5mA commonly used as a pain management application CV 0 200V Stepping 0 5V 20us 1 000us Stepping 5us PARAMETERS 1 250 Hz Stepping 1 Hz Phase Duration Expressed in us is the time it takes to complete one phase of a pulse The length affects the type of nerve recruited Cycle Time Continuous 10 10 10 20 10 30 10 50 Custom the number of pulses that occur in a one Treatment Time 1 60 Minutes second period of time and is denoted in Hz or Pulses Per Second pps TENS Symmetrical Biphasic Frequency Modulation Expressed in Hz varies the frequency to Output Mode Electrodes reduce accommodation Example When the Mode selection CC Constant Current or CV Constant voltage pulse frequency is set to 80 Hz and the i l l frequency modulation is set to 40 Hz the Intensity CC 0 200mA S
58. trodes in combination with a conductive medium When properly applied this will ensure low impedance between the skin and the stimulator during treatment Follow the guidelines below when using these electrodes e Prior to initial use put enough conductive medium to saturate the rubber electrode or to cover the entire surface area of the rubber electrode Only use a conductive medium specifically approved for electrotherapy stimulation DO NOT use a medium with an alcohol based content e Place the electrodes on the patient and apply an elastic wrap around the electrode to secure it in place 230 InTENSity Professional Series CX4 EX4 e Depending on the electrode size use two or three wraps to maximize the contact surface e After use clean the electrodes as described in the user maintenance instructions on pages 46 47 Self Adhesive Electrodes Self adhesive electrodes have higher series impedance than flexible rubber electrodes This can cause the stimulator to terminate treatment at higher current amplitudes When this occurs it is recommended to continue the treatment with flexible rubber electrodes properly moistened with a conductive medium Self adhesive electrodes are not recommended for use with currents that contain a DC component Connection and Disconnection Reactions Constant Current CC output characteristics may cause unpleasant connection and disconnection reactions if the electrodes are not securely
59. uct DESCHDUON 2c ux cd te iw see wed eas 28 32 Home Screen Display EX4 CX4 0 0 es 29 Main Therapy Display cereum due 3c ES PROPER A ea de 29 Touchscreen DISDIS 32452406 Serm dom 309 cx arie ab om CR e 30 Electrotherapy Treatment Screen 0000 ee eee 30 Ultrasound Treatment Screen 0 00 31 Combination Therapy Treatment Screen 31 NAVIQGANON M M 32 44 Application Info Electrotherapy 32 33 Before Treatment 2 0000 cece eee eee 32 Rubber Electrodes Flexible nannan nananana nnna 32 Self Adhesive Electrodes n nananana aaa 32 Connection and Disconnection Reactions 32 Electrotherapy Set Up Clinical Protocols 33 Channel Selection 0000 cee eee 34 Treatment Time Adjustment Lll 34 Slab Terap 26808004 os det awd ee Sede DE dou an 34 35 Storing Favorites 0 00 cece ee ees 35 Roscoe Medical InTENSity Professional Series CX4 EX4 Navigation COM aaa nacen ac eve Geese wh RC E ec es 33 44 Operating Details asic csv ea ce nor eee ee ee nmn 45 Electrotherapy Set Up Manual Operation 36 System Settings 3 c r dere ease oy a deter dte uode pde ee eh ri fpa o ic 45 Waveform Selection 0000 ce eee eee ees 36 Setting Adjustment 0 2 00 ccc eee eee 45 Channel Selection 0000 cc eee 36 Adjusting Current Amplit
60. ude llle 45 Treatment Time Adjustment 200000 00 eee 37 ese E eee 45 Selako eTe NEMPE E 37 Current PONY s ooa eer dt Eno ima x XH bU ae ces edet 45 Storing Favorites isses nnn 37 Maintenance 0cce cece nh hn 46 47 Ultrasound Therapy Application eres 38 Cleaning Device sss 46 Contact Control ciis nnne 38 Cleaning Display Panel 00 00 cee eee eee eee 46 Contact Medium 1 1 e ieee eee nnn 38 Cleaning Electrodes 00000 cece nee 46 Before Treatment 1 2 ee eee eee eee eee 38 Cleaning Lead Wires and Cables 00005 47 During Treatment sisse n nnne 38 Cleaning Ultrasound Applicator 0 ee esee 47 After Treatment 0 000 eee eee 38 i Ultrasound Therapy Set Up Clinical Protocols 39 Troubleshooting m3 2 2 33 8 33 23253 223223 2 33 2 33 23233533 48 50 Parameters LL LLL LLL LL coco eee cece eee 40 Error Codes CETE 48 Treatment Time Adjustment 0 ceeeeeeees 40 Technical Maintenance llle 49 Start Therapy MEMINI 40 End Of Life uu esd aac dee Cac ac bow 1 Ec e e E ee 50 Storing Favorites 62 0 canes utei io aro mpi e D ed dece aca 41 Safety And Performance Standards 50 Ultrasound Therapy Set Up Manual Operation 41 EMG Table ccttenadectadeateccasnasbigececen RR od 51 53 Parameters aua aant 1 wal edd sb Ea wake 2 aod d
61. ultrasound should not be applied over the pregnant or potentially pregnant uterus Therefore therapeutic ultrasound should not be applied over the uterus unless specific assurance can be attained from the patient that she is not pregnant Areas of thrombophlebitis should not be treated with therapeutic ultrasound due to the increased possibility of clotting or dislodging a thrombus Conditions where this might occur are deep vein thrombosis emboli and severe atherosclerosis Tissues previously treated by deep x ray or other radiation should not be exposed to therapeutic ultrasound Ultrasonic treatment over the stellate ganglion the spinal cord after laminectomy subcutaneous major nerves and the cranium should be avoided This device should not be used over the gonads testicles or to the developing fetus This device should not be used over the heart This device should not be used on the brains This device should not be used on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result This device should not be used over or applied to the eyes This device should not be use on the facial sinus as this exposes the eyes to the same hazards Ultrasound should not be used on unconscious patients or over anesthetic areas On the head or near the pharynx or larynx InTENSity Professional Series CX4 EX4 APPLICATOR MOVEME
62. vironments e Set power switch to On e Power LED indicator is lit green indicating that the device is connected to the power supply e The device will initialize and perform a self test This may take a while e At the end of the self test the device enters the Home Menu and is ready for use DISCONNECTION FROM POWER e When you have finished treatments turn the device off by setting the power switch on the back of the device to Off When the green power LED turns off the device is now disconnected from the power supply InTENSity Professional Series CX4 EX4 Package Contents InTENSity EX4 InTENSity CX4 Description SKU Qty Description SKU Qty 2 x 2 Electrodes 4 pk 2 x 3 5 Electrodes 4 pk Ultrasound Combination Device 2 x 2 Electrodes 4 pk 2 x 3 5 Electrodes 4 pk EA2085 NC VT 2 3 x 5 Dispersive Electrode 2 pk EA3050WC VT 1 2 5 x 3 5 Rubber Electrode 4 pk ER2535B2 1 2 75 x 4 3 Rubber Electrode 4 pk ER274382 1 DETGETCTTIUTITT T NERIS TU 2 X 23 5 Strap for Rubber Electrodes CO 3 8 oz Bottle of Therasonic Ultrasound 85288 Transmission Gel Optional Accessories 78 Lead Wires 2 bag WQ8000 EN InTENSity Therapy Cart with Storage DQCART 78 Combination Lead Wire Green WQ8000 SNGL a 1 cm Sound Head For use with CX4 Only DQ8000W1 CD with Electronic Manual DQDISC BEN 3 x 5 Dispersive Electrode 2 pk 2 5 x 3 5 Rubber Electrode 4 pk 2 75 x 4

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