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This manual is valid for the TENS 3000 Stimulator This user manual is published by Richmar. Richmar does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice. Amendments may however be published in new editions of this manual.
TABLE OF CONTENTS 1. GENERAL INFORMATION _______________________________ 4 1.1 General Description 1.2 Medical Background 1.3 Indication for Use 2. SAFETY INFORMATION _________________________________ 6 2.1 Contraindications 2.2 Warnings, Cautions, Adverse Reactions 3. PRESENTATION _______________________________________ 11 3.1 Device Features 4. SPECIFICATIONS ______________________________________ 11 4.1 Device Contents 4.2 Technical Information 4.3 The Waveforms of the Stimulation Programs...
1. GENERAL INFORMATION 1.1 General Description The TENS 3000 is a battery operated pulse generator that sends electrical impulses electrodes to the body and reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other.
You may wish to discuss this method of pain management treatment with your physician or therapist. 1.3 Indication For Use TENS 3000 Stimulator may be used for the following conditions: TENS: Symptomatic relief of chronic intractable pain. Acute post-traumatic pain.
2. SAFETY INFORMATION Read instruction manual before operating. Be sure to comply with all “Contraindications”, Warnings”, “Cautions” and “Adverse reactions” in the manual. Failure to follow instructions may cause harm to user or device. Safety Symbols Used in this Manual Indicates a potentially hazardous situation which, if not avoided, could result in serious injury and equipment WARNING...
2.2 Warnings, Cautions and Adverse Reactions WARNINGS: This device should be used only under the continued supervision of a licensed physician or practitioner. 2. The long-term effects of chronic electrical stimulation are unknown. Electrical stimulation devices DO NOT have any curative value. 3.
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16. NEVER use on the areas of the skin which lack normal sensation. 17. Apply the electrodes to clean, dry, and unbroken skin only. 18. Keep electrodes separate during treatment, electrodes in contact with each other could result in improper stimulation or skin burns. 19.
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15. Effectiveness is highly dependent upon the patient and the selection of therapy by a person qualified in the management of pain. 16. Isolated cases of skin irritation have occurred at the site of the electrode placement following long-term application. If this occurs, discontinue use and consult your physician.
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ADVERSE REACTIONS: Skin irritation from the electrode gel and electrode burns are potential adverse reactions. If skin irritation occurs, discontinue use and consult your physician. Note: Always use electrodes that are legally marketed and sold in the United States under 510K guidelines. 2.
4.2 Technical Information Channel Dual, isolated between channels Power supply One 9 volt battery, (alkaline or nickel-cadmium rechargeable) Operating 5°C to 40°C (41°F to 104°F) with a relative humidity of Conditions 30%-75%,atmospheric pressure from 700 to 1060 Hpa Storage -10°C to 50°C (14°F to 122°F) with a relative humidity of Conditions 10%-90%,atmospheric pressure from 700 to 1060 Hpa Dimensions...
5. INSTRUCTIONS FOR USE 5.1 Battery 5.1.1 Check/Replace the Battery Over time, in order to ensure the functional safety of the device, changing the battery is necessary. Slide the front battery cover down to open. 2. Insert the 9V battery into the battery compartment.
CAUTION: Before using the device for the first time, you are strongly advised to take careful note of the contraindications and safety measures detailed at the beginning of this manual (on page 5-9 and throughout manual), as this powerful equipment is neither a toy nor a gadget! 5.2 Connect Lead Wires to Electrodes Ensure the device is in the OFF position before proceeding to this step.
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5.3.1 Place Electrode on Skin Apply electrodes to the exact site indicated by your physician or therapist. Before applying electrodes, be sure the skin surface over which electrodes are placed is thoroughly cleaned and dry. Make sure the electrodes are pressed firmly to the skin and make good contact between the skin and the electrodes.
5.4 Adjusting the Controls 5.4.1 Slide Cover: A slide-on panel cover covers the controls for Pulse Width, Pulse Rate, Mode Selector and Modulation Selector. Your medical professional may wish to set these controls for you and request that you leave the cover in place. 5.4.2 Display LED: Each of the LEDs illuminates green whenever the electronics of the device create a current impulse.
5.4.4 Pulse Width Control This dial adjusts the length of time each electrical signal is applied through the skin, which controls the strength and sensation of the stimulation. 5.4.5 Timer Control Treatment time of TENS can be preset with Timer Control. This switch has 3 positions, 15, 30 and C (Continue).
6. CLEANING AND CARE 6.1 Tips for Skin Care Follow these suggestions to avoid skin irritation, especially if you have sensitive skin: Wash the area of skin you will be placing the electrodes on with soap. Rinse thoroughly and dry the area completely before and after placing electrodes.
6.3 Cleaning Electrodes Electrodes cannot be cleaned as they are made with a self- adhesive gel. Electrodes can be re-used and number of uses vary from user to user. 2. If electrodes do not stick to the skin completely (including lifting edges) please replace with new electrodes.
7. TROUBLESHOOTING If your device does not seem to be operating correctly, refer to the chart below to determine what may be wrong. Should none of these measures correct the problem, the device should be serviced. Problem Possible Cause Solution Display fails to Battery contact failure.
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7 TROUBLESHOOTING CONT Stimulation is Improper electrode and Reposition electrode and applicator. ineffective applicator placement unknown. Contact clinician. The skin Using the electrodes on the Reposition the electrodes. If at any becomes red same site every time. time you feel pain or discomfort and/or you feel stop use immediately.
8. STORAGE For prolonged pauses in treatment, store the device in a cool dry room and protect it against heat, sunshine and moisture and remove the battery to avoid battery leaking. 2. Store the device in a cool, well-ventilated place. 3.
10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES Guidance and manufacturer’s declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user assures that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions...
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Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic level...
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Immunity IEC 60501 Compliance Electromagnetic environment guidance test test level level Portable and mobile RF Communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) as recommended below, according to the maximum output power of the communications equipment...
11. GLOSSARY OF SYMBOLS Attention: Read the operating instruction before use! Equipment capable of delivering output values in excess of 10mA r.m.s. or 10V r.m.s. averaged over any period of 5s. Electrical devices are recyclable material and should not be disposed of with household waste after their useful life! Help us to protect the environment and save resources and take this device to the ap- propriate collection points.
12. WARRANTY Please contact your dealer in case of a claim under the warranty. If you have to send the unit back to your provider, enclose a copy of your receipt and state what the defect is. The following warranty terms apply: The warranty period for device is one year from date of purchase.
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5. Return Labels or Call Tags can be issued by our customer service department to return merchandise. 6. Associated fees and return freight charges will apply. All returns of dropshipped items are subject to a restocking fee as well as inbound and outbound freight charges.
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