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TheraTouch® CX4/EX4 This user manual is valid for the TheraTouch® CX4 & TheraTouch® EX4. This user manual is published by Richmar. Richmar 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.
TheraTouch® CX4/EX4 TABLE OF CONTENTS Forward........................1 Safety Precautions ....................2 Do Not Use With These Medical Devices........2 Do Not Use This Device Under These Conditions .....2 Electrode Warnings ..................3 General Warnings ..................3 Electrotherapy Warnings ...............4 Ultrasound Warnings ................4 Cautions & General Precautions ............5 Intended Use ......................6 Electrotherapy Indications &...
TheraTouch® CX4/EX4 FOREWARD INTENDED USER/OPERATOR IMPORTANT SAFETY PRECAUTIONS AND WARNINGS This manual has been written for the users of the TheraTouch® CX4 and EX4 medical It is important that you read all the devices. It contains general information warnings and precautions included in this on the operation, precautionary practices, manual because they are intended to keep and maintenance information.
TheraTouch® CX4/EX4 SAFETY PRECAUTIONS • On open wounds or rashes, or over DANGER swollen, red, infected, or inflamed THIS STIMULATOR MUST NOT BE areas or skin eruptions (e.g., phlebitis, USED IN COMBINATION WITH THE thrombophlebitis, varicose veins); or FOLLOWING MEDICAL DEVICES: on top of, or in proximity to, cancerous Internally transplanted electronic lesions.
TheraTouch® CX4/EX4 SAFETY PRECAUTIONS WARNINGS AND PRECAUTIONS • Always turn the power off before REGARDING THE ELECTRODES: removing or changing the electrode location. • Apply electrodes to normal, healthy, dry, • DO NOT leave electrodes attached to clean skin (of adult patients) because it may otherwise disrupt the healing the skin after treatment.
TheraTouch® CX4/EX4 SAFETY PRECAUTIONS • • Make certain there are no cracks or Heating of the joint capsule in acute or damage to any wires attached subacute arthritis should be avoided. to the device. • Additional precautions should be used when ultrasound is used on ELECTROTHERAPY WARNINGS patients with the following conditions:...
TheraTouch® CX4/EX4 SAFETY PRECAUTIONS • This device should not be used adjacent CAUTION to or stacked with other equipment and if CAUTION WHILE USING THE STIMULATOR: adjacent or stacked use is necessary, the • If the stimulator is not functioning equipment should be observed to verify properly or the patient feels normal operation in the configuration in...
TheraTouch® CX4/EX4 INTENDED USE ELECTROTHERAPY INDICATIONS & advisable, for general medical purposes, to suppress heat or fevers. CONTRAINDICATIONS • Safety has not been established for the Indications for TENS, EMS, NMS, NMS use of therapeutic electrical stimulation Burst, Russian (RUSS), High Voltage Pulsed during pregnancy.
TheraTouch® CX4/EX4 INTENDED USE • • Tissues previously treated by deep x– This device should not be used on ray or other radiation should not be ischemic tissues in individuals with exposed to therapeutic ultrasound. vascular disease where the blood supply would be unable to follow the increase •...
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS ELECTROTHERAPY STIMULATOR OUTPUT PARAMETERS IFC-4P: IFC (Interferential) Traditional (4 Pole) IFC-4P Sinewave Interferential Current is a medium Output Mode Electrodes frequency waveform distributed through Mode CC (Constant Current) or two channels (four electrodes)*. The Selection CV (Constant Voltage) currents cross each other in the body at the area requiring treatment.
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS Premodulated (2 Pole) STIMULATOR OUTPUT PARAMETERS Premodulated Current is a medium Premodulated (2 Pole) Sinewave frequency waveform. Current comes out Output Mode Electrodes of one channel (only two electrodes). A bipolar technique in which the two Mode CC (Constant Current) or frequencies are “mixed”...
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS TENS (Biphasic) STIMULATOR OUTPUT PARAMETERS The Asymmetrical Biphasic and the TENS Asymmetrical Biphasic Symmetrical Biphasic waveforms are Output Mode Electrodes often used in TENS (Transcutaneous Electrical Nerve Stimulation) applications. Mode CC (Constant Current) or TENS is low frequency waveform and has selection CV (Constant voltage) a short pulse duration.
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS RAAS (Biphasic) STIMULATOR OUTPUT PARAMETERS Rapid Agonist Antagonist Sequencing RAAS Biphasic (RAAS) is proposed to mimic muscle- Output Mode Electrodes firing patterns of healthy individuals. It uses the electrical stimulation of Mode CC (Constant Current) or sensory and motor nerves to achieve selection CV (Constant voltage)
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS Russian Stimulation STIMULATOR OUTPUT PARAMETERS Russian Current is a medium frequency Russian - Medium Frequency Rect. rectangle waveform, delivered in bursts or Carrier 2.5 KHz series of pulses. This method was claimed Frequency by its author (Kots) to produce maximal muscle strengthening effects without Frequency 20 –...
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS High Volt STIMULATOR OUTPUT PARAMETERS The High Volt waveform has a very brief Hi Volt - Pulsed Current pulse duration characterized by 2 distinct Frequency 1 – 120 Hz, Stepping 1 Hz peaks delivered at high voltage. High voltage causes a decreased skin resistance Polarity Positive, or Negative,...
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS Microcurrent STIMULATOR OUTPUT PARAMETERS Microcurrent is a monophasic waveform Microcurrent - Monophasic of very low intensity which replicates Frequency 0.1 – 1,000 Hz, the body’s use of natural frequencies Stepping 0.1 Hz/1 Hz when repairing or growing its new cells. It creates a physiological electric modality Polarity Positive, Negative,...
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS STIMULATOR OUTPUT PARAMETERS NMS is a symmetrical biphasic waveform NMS - Symmetrical Biphasic with a 120 μs interphase interval. Because Output Mode Electrodes the pulse is relatively short, it is suitable for applications requiring high intensities, Mode CC (Constant Current) or such as in muscle strengthening protocols.
TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS ULTRASOUND THERAPY ULTRASOUND PARAMETERS PARAMETERS Ultrasound Expressed in MHz, it is Frequency 1 MHz*, 3 MHz* Frequency the frequency of the Duty Cycles 10% – 100%,Continuous, ultrasound waves. The Stepping 10% ultrasound frequency determines the Pulse duration 1 –...
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TheraTouch® CX4/EX4 WAVEFORM SPECIFICATIONS Parameter Limit CONNECTION TO AC POWER For security, the device has some Insert the power cable into the socket on limitations for electrotherapy. The the back of the device and plug it into a maximum intensity has a relationship with grounded wall outlet.
TheraTouch® CX4/EX4 PRODUCT DESCRIPTION The TheraTouch® devices are a family of Protocols can run on linked or clinical therapy devices which offers the independent channels. With practitioner a wide range of treatment independent channels, two or four options. These devices share an identical different protocols can be control panel equipped with a full color performed simultaneously.
TheraTouch® CX4/EX4 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: Navigation Bar Selected Parameters...
TheraTouch® CX4/EX4 PRODUCT DESCRIPTION ULTRASOUND TREATMENT SCREEN Remaining Treatment Time Output Value Unit of Output Value (w/cm COMBINATION THERAPY SCREEN Ultrasound Output Indicator Electrode Output Indicator Remaining Treatment Time Electrotherapy Output Value Unit of Output Value (mA) Ultrasound Output Value Unit of Output Value (w/cm2) APPLICATION INFORMATION ELECTROTHERAPY...
TheraTouch® CX4/EX4 APPLICATION INFORMATION Depending on the electrode size, use two Electrodes smaller than 3" x 5" are not or three wraps to maximize the contact recommended for use with currents that surface. contain a DC component. After use clean the electrodes as described Connection and Disconnection Reactions in the user maintenance instructions on Constant Current (CC) output...
TheraTouch® CX4/EX4 NAVIGATION ELECTROTHERAPY SETUP – CLINICAL PROTOCOLS (CONT.) Clinical Protocols • Use the central control dial to scroll through the pages, then select the desired clinical protocol button. • For more information about the clinical protocol, press the button next to the desired protocol. Protocol Information •...
TheraTouch® CX4/EX4 NAVIGATION ELECTROTHERAPY SET-UP — CLINICAL PROTOCOLS (CONT.) Treatment Time Adjustment • Touch the timer. The color will change to orange. Adjust the treatment time with the central control dial. Start Therapy • Once your parameters and timers are set, start the therapy by touching the output intensity on the bottom of the screen.
TheraTouch® CX4/EX4 NAVIGATION ELECTROTHERAPY SET-UP — CLINICAL PROTOCOLS (CONT.) • Enter the name of your favorite using the keyboard. • Press to store your favorite under the name just entered. • NOTE: Once saved, Favorites can be retrieved from the Electrotherapy, Ultrasound and Combination Menus.
TheraTouch® CX4/EX4 NAVIGATION ELECTROTHERAPY SET-UP — MANUAL OPERATION (CONT.) Parameters • Adjust the parameters by touching CHRONIC PAIN (2 ELECTRODES) 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.
TheraTouch® CX4/EX4 NAVIGATION ELECTROTHERAPY SET-UP — MANUAL OPERATION (CONT.) 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.
TheraTouch® CX4/EX4 NAVIGATION To optimize ultrasound transmission, clean pulsed mode or vice versa. the skin of the treatment area with soap or When there are signs that the ultrasound a 70% alcohol solution. transmission is bad, add more contact gel Any areas with excess hair should be or spread it with the applicator.
TheraTouch® CX4/EX4 NAVIGATION ULTRASOUND THERAPY SET-UP — CLINICAL PROTOCOLS (CONT.) Clinical Protocols • Use the central control dial to scroll through the pages, then select the desired clinical protocol button. • For more information about the clinical protocol, press the button next to the desired protocol.
TheraTouch® CX4/EX4 NAVIGATION ULTRASOUND THERAPY SET-UP — CLINICAL PROTOCOLS (CONT.) 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. Manufacturer supplied conductive gel is recommended.
TheraTouch® CX4/EX4 NAVIGATION ULTRASOUND THERAPY SET-UP — MANUAL OPERATION Home • The Home Menu gives access to all functions of the unit. • Select the Ultrasound button. Manual Operation • The Ultrasound menu provides access to the following functions: • Clinical Protocols •...
TheraTouch® CX4/EX4 NAVIGATION ULTRASOUND THERAPY SET-UP — MANUAL OPERATION (CONT.) 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. Manufacturer supplied conductive gel is recommended.
TheraTouch® CX4/EX4 NAVIGATION COMBINATION THERAPY SET-UP — MANUAL OPERATION PLEASE NOTE: Combination Therapy combines ultrasound & 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.
TheraTouch® CX4/EX4 NAVIGATION COMBINATION THERAPY SET-UP — MANUAL OPERATION (CONT.) 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.
TheraTouch® CX4/EX4 OPERATING DETAILS SYSTEM SETTINGS Home Screen • From the Home Menu, choose “SystemSettings” to access to all the functions of the unit. • NOTE: You can reach this menu at any time by pressing the Home button Settings Adjustment •...
TheraTouch® CX4/EX4 MAINTENANCE CLEANING CARE AND STORAGE OF ELECTRODES • The life of the electrodes varies Cleaning of the Device depending on skin conditions, • Switch off the device and disconnect it storage temperature,the amount of use, from the power supply. type of stimulation and stimulation site.
TheraTouch® CX4/EX4 TROUBLESHOOTING ERROR CODES Error Problem Still Reason for Tone Solution Code Exists? There is no electrode load Check the electrode pads and lead Contact detected. The connection wires. Change lead wires manufacturer tech of electrodes or lead wires or electrodes.
TheraTouch® CX4/EX4 TROUBLESHOOTING TECHNICAL MAINTENANCE WARNING: • This unit operates with high voltages. No CAUTION attempt should be made to disassemble • Electrical safety of the device relies on a the unit. Maintenance and repair should properly grounded electrical connection be carried out by authorized personnel via the power cord.
TheraTouch® CX4/EX4 TROUBLESHOOTING END OF LIFE MEDICAL DEVICE CLASSIFICATION The TheraTouch® CX4 and EX4 contain 21 CFR 1050.10 materials that can be recycled and/or are This equipment complies with all noxious to the environment. Specialized requirements of 21 CFR1050.10, companies can dismantle the unit and sort Performance Standard for Ultrasonic out these materials.
TheraTouch® CX4/EX4 EMC TABLE EMC DETAILS Medical electrical devices such as The TheraTouch® should only be operated the TheraTouch® are subject to with the original power cord specified in special precautions with regard to the list of contents delivered. electromagnetic compatibility (EMC) and Operating the device with any other must be installed and commissioned in power cord can lead to increased...
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TheraTouch® CX4/EX4 EMC TABLE GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The TheraTouch® device is intended for use in the electromagnetic environment specified below. The customer or the user of the TheraTouch® device should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Level...
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TheraTouch® CX4/EX4 EMC TABLE The main features of the TheraTouch® 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 – ELECTROMAGNETIC INTERFERENCE IMMUNITY The TheraTouch®...
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TheraTouch® CX4/EX4 EMC TABLE Theoretically, it is not possible to exactly Above the frequency range from 150 kHz predict the field strengths of fixed to 80 MHz, the field transmitters such as base stations for strength should be less than 3 V/m. radio telephones and land mobile radios, Recommended separation distances amateur radio stations, AM and FM radio...
The following warranty power cords have a one year warranty terms apply: from date of original device purchase. Richmar's sole obligation in the case of The following is excluded any breach of its warranties set forth under the warranty:...
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