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This user manual is valid for the TheraTouch® CX2, 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® CX2/CX4/EX4 TABLE OF CONTENTS Foreword........................1 Safety Precautions ....................2 Do Not Use With These Medical Devices........2 Do Not Use This Device Under These Conditions .....2 Electrode Warnings and Precautions ..........2 General Warnings ..................2 Electrotherapy Warnings & Precautions ........4 Ultrasound Warnings ................4 Cautions While Using the Stimulator ..........5 Intended Use ......................6...
TheraTouch® CX2/CX4/EX4 FOREWORD INTENDED USER/OPERATOR IMPORTANT SAFETY PRECAUTIONS AND WARNINGS This manual has been written for the users of the TheraTouch® CX2, CX4 It is important that you read all the and EX4 medical devices. It contains warnings and precautions included in this general information on the operation, manual because they are intended to keep precautionary practices, and maintenance...
TheraTouch® CX2/CX4/EX4 SAFETY PRECAUTIONS • On open wounds or rashes, or over DANGER swollen, red, infected, or infl amed DO NOT USE WITH THESE MEDICAL areas or skin eruptions (e.g., phlebitis, DEVICES: thrombophlebitis, varicose veins); or Internally transplanted electronic on top of, or in proximity to, cancerous medical devices, such as a pacemaker.
TheraTouch® CX2/CX4/EX4 SAFETY PRECAUTIONS • Apply electrodes to normal, healthy, dry, • DO NOT leave electrodes attached to clean skin (of adult patients) because the skin after treatment. it may otherwise disrupt the healing • DO NOT lean against or lay on process.
TheraTouch® CX2/CX4/EX4 SAFETY PRECAUTIONS ELECTROTHERAPY WARNINGS & • Additional precautions should be used PRECAUTIONS: when ultrasound is used on patients with the following conditions: • TENS therapy has not been established for pain of central origin. Laminectomy, i.e., when major covering tissues have been •...
TheraTouch® CX2/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 confi guration in...
• Maintaining or increasing range of motion * Ultrasound indications are applicable to the • Immediate post-surgical stimulation TheraTouch CX2/CX4 devices only. of calf muscles to prevent venous Contraindications thrombosis (DO NOT stimulate both calf muscles simultaneously) The established contraindications to heat...
TheraTouch® CX2/CX4/EX4 INTENDED USE • This device should not be used over the in metabolic demand and tissue necrosis gonads/testicles or to the developing might result. fetus. • This device should not be used over or • This device should not be used over the applied to the eyes.
TheraTouch® CX2/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 Mode CC (Constant Current) or through two channels (four electrodes)*. Selection CV (Constant Voltage) The currents cross each other in the body at the area requiring treatment.
TheraTouch® CX2/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® CX2/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® CX2/CX4/EX4 WAVEFORM SPECIFICATIONS RAAS (Biphasic) STIMULATOR OUTPUT PARAMETERS Rapid Agonist Antagonist Sequencing RAAS Biphasic (RAAS) is proposed to mimic muscle-firing Output Mode Electrodes patterns of healthy individuals. It uses the electrical stimulation of sensory and Mode CC (Constant Current) or motor nerves to achieve a skeletal muscle selection CV (Constant voltage)
TheraTouch® CX2/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® CX2/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® CX2/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® CX2/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® CX2/CX4/EX4 ULTRASOUND SPECIFICATIONS ULTRASOUND THERAPY ULTRASOUND PARAMETERS PARAMETERS Ultrasound Expressed in MHz, it is Frequency 1 MHz*, 3 MHz* Frequency the frequency of the 10% – 100%, Continuous, ultrasound waves. The Duty Cycles Stepping 10% ultrasound frequency determines the Modulation Waveform Square wave penetration depth, which...
TheraTouch® CX2/CX4/EX4 DEVICE SPECIFICATIONS Parameter Limit OPERATING ENVIRONMENTAL For security, the device has some Temperature 0°C (32°F) to 40°C (104°F) limitations for electrotherapy. The Relative 10% – 90% maximum intensity has a relationship with inuous, Humidity the frequency and pulse duration following below table: Atmosphere 700hPa –...
TheraTouch® CX2/CX4/EX4 PRODUCT DESCRIPTION The TheraTouch® devices are a family of clinical reactions, it is recommended to use the therapy devices which off ers the practitioner a manufacturer supplied electrodes. wide range of treatment options. These devices CAUTION share an identical control panel equipped with DO NOT attach electrodes before device is a full color touch screen making treatment set- turned on.
TheraTouch® CX2/CX4/EX4 DEVICE OPERATION 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® CX2/CX4/EX4 DEVICE OPERATION 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/cm APPLICATION INFORMATION ELECTROTHERAPY...
NAVIGATION This manual contains instructions for For TheraTouch CX2/CX4 set-up the TheraTouch® CX2, CX4 & EX4. For instructions, refer to the Navigation TheraTouch EX4 set-up instructions, refer Section of this manual, which is divided to the Navigation —...
TheraTouch® CX2/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® CX2/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® CX2/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® CX2/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® CX2/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® CX2/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® CX2/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® CX2/CX4/EX4 NAVIGATION ULTRASOUND THERAPY SET-UP — CLINICAL PROTOCOLS (CONT.) To ensure effi cient 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® CX2/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® CX2/CX4/EX4 NAVIGATION ULTRASOUND THERAPY SET-UP — MANUAL OPERATION (CONT.) To ensure effi cient 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® CX2/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® CX2/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® CX2/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® CX2/CX4/EX4 MAINTENANCE CLEANING THE DEVICE Make sure that no ultrasound gel remains on the applicator. We further recommend Cleaning Contact Surfaces cleaning the applicator and cable daily, • Switch off the device and disconnect it using lukewarm water. The applicator can from the power supply.
TheraTouch® CX2/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® CX2/CX4/EX4 TROUBLESHOOTING TECHNICAL MAINTENANCE WARNING: • CAUTION This unit operates with high voltages. No 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® CX2/CX4/EX4 TROUBLESHOOTING END OF LIFE MEDICAL DEVICE CLASSIFICATION The TheraTouch® CX2, CX4 and EX4 21 CFR 1050.10 contain materials that can be recycled This equipment complies with all and/or are noxious to the environment. requirements of 21 CFR1050.10, Specialized companies can dismantle the Performance Standard for Ultrasonic unit and sort out these materials.
TheraTouch® CX2/CX4/EX4 EMC TABLE EMC DETAILS Medical electrical devices such as the The TheraTouch® should only be operated TheraTouch® are subject to special with the original power cord specified in precautions with regard to electromagnetic the list of contents delivered. compatibility (EMC) and must be installed Operating the device with any other and commissioned in accordance with the...
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TheraTouch® CX2/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® CX2/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® CX2/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 strength should be transmitters such as base stations for less than 3 V/m. radio telephones and land mobile radios, Recommended separation distances amateur radio stations, AM and FM radio...
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