Roscoe Medical InTENSity Micro Combo Instruction Manual
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Roscoe Medical InTENSity Micro Combo Instruction Manual

Roscoe Medical InTENSity Micro Combo Instruction Manual

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  • Page 1 INSTRUCTION MANUAL...
  • Page 2 Combo TENS/MIC Stimulator This user manual is published by Roscoe Medical, Inc. Roscoe Medical 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.

  • Page 3: Table Of Contents

    TABLE OF CONTENTS 1. SAFETY INFORMATION………………………………………………………… 1.1 General Description 1.2 Medical background 1.3 Indication for use 1.4 Contraindications 1.5 Warnings, Cautions, Adverse Reactions 2. PRESENTATION..………………………………………………………………..… 11 2.1 Front and Rear panel 2.2 LCD display 3. SPECIFICATION………………………………………....…..……………….. 14 3.1 Accessories 3.2 Technical information 3.3 The waveforms of the stimulation programs 4.

  • Page 4: Safety Information

    1. SA FETY IN FOR MATION 1.1 General InTENSity Micro Combo is a portable electrotherapy device featuring two therapeutic modes: Transcutaneous Electrical Nerve Stimulation (TENS) and Microcurrent (MIC), which are used for pain relief and electrical muscle stimulation. The stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin.

  • Page 5: Indication For Use

    HOW TENS WORKS There is nothing "magic" about Transcutaneous Electrical Nerve Stimulations (TENS). TENS is intended to be used to relieve pain. The TENS unit sends comfortable impulses through the skin that stimulate the nerve (or nerves) in the treatment area. In many cases, this stimulation will greatly reduce or eliminate the pain sensation the patient feels.

  • Page 6: Contraindications

    IMPORTANT SAFETY INFORMATION! Read instruction manual before operating. Be sure to comply with all “Contraindications”, Warnings”, “Cautions” and “Adverse reactions” outlined in the manual. Failure to follow these instructions may cause harm to the user or the device. 1.4 Contraindications 1.
  • Page 7 3. TENS is a symptomatic treatment and, as such, suppresses the sensation of pain, which would otherwise serve as a protective mechanism. 4. Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. Do not use during pregnancy unless directed by your physician.
  • Page 8 18. Keep electrodes separate during treatment, electrodes in contact with each other could result in improper stimulation or skin burns. 19. Keep the stimulator out of reach of children. 20. Consult your doctor if you have any questions or concerns before using this device.
  • Page 9 condition should not use this device without first consulting a physician. 13. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or silicone rubber. If rash develops or pain persists, discontinue use and consult a doctor. 14.
  • Page 10 ADVERSE REACTIONS: 1. 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.

  • Page 11: Presentation

    2. PRESENTATION 2.1 Front and Rear Panel 1. Output socket: electric signal output after connection of the cable with adhesive electrodes on Channel 1. 2. Output socket: electrical signal output after connection of the cable with adhesive electrodes on channel 2. 3.
  • Page 12 set the application program and the parameter of the waveform in the setting state. 8. Decreases [] the output intensity of channel 2. It is also used to set the application program and the parameter of the waveform in the setting state and unlocks the current treatment program.

  • Page 13: Lcd Display

    2.2 LCD Display 1. Displays therapeutic mode (TENS/MIC). 2. Displays therapeutic program for TENS/MIC (Burst (B), Normal (N), Modulation (M), and Modulation 1 (M1)). 3. Displays the cycle time for TENS and MIC therapeutic mode in setting state. 4. Timer symbol 5.

  • Page 14: Specification

    3. SPECIFICATION 3.1 Accessories DESCRIPTION QUANTITY Electrical Stimulator Device 1 pieces Electrode Leads 2 pieces 1.5” x 1.5” Adhesive Electrodes 4 pieces 9V Alkaline Battery, type 6LR61 1 piece Instruction Manual 1 piece Carrying Case 1 piece AC Adapter (optional) 1 piece 3.2 Technical Information Channel...
  • Page 15 Technical specifications for Transcutaneous Electrical Nerve Stimulator (TENS) Mode Waveform Mono-phase square pulse wave Adjustable, 0~105mA peak at 1000 ohm load Pulse Amplitude each channel, 1mA/step Pulse Width Adjustable from 50 to 300µs, 10µs/step Pulse Rate Adjustable, from 1 to 150 Hz, 1 Hz/step Burst rate: Adjustable, 0.5 ~ 5Hz Burst (B) Pulse width adjustable, 50~300µS...
  • Page 16 Technical Specifications for Microcurrent (MIC) Mode Waveform Mono-phase square pulse wave Adjustable 0~0.7mA; peak at 1000 ohm load each Pulse Amplitude channel, 0.01mA/step Adjustable from 0.1Hz to 150Hz; there into, 0.1Hz/step in the range of 0.1Hz~2Hz, 1Hz/step in the range of 2Hz ~150Hz. Pulse Rate (P.R.) Adjustable (in correlation to the Pulse Rate), from 2 to 200ms, 1ms/step...

  • Page 17: The Waveforms Of The Stimulation Programs

    3.3 The Waveforms of the Stimulation Programs TENS - Burst (B) TENS - Normal (N) TENS - Pulse Width Modulation (M) TENS - Pulse Rate Modulation (M1) Microcurrent – Constant...

  • Page 18: Instruction For Use

    4. INSTRUCTIONS FOR USE 4.1 Battery 4.1.1 Check/Replace the battery Over time, in order to ensure the functional safety of the device, changing the battery is necessary. Slide the battery compartment cover to open. Insert the 9V battery into the battery compartment.

  • Page 19: Connect Electrodes To Lead Wires

    2. If a battery has leaked, avoid contact with skin, eyes and mucus membranes. Rinse the affected areas with clear water immediately and contact a physician immediately. 3. Battery should not be charged, dismantled, thrown into fire or short-circuited. 4. Protect battery from excess heat. 5.

  • Page 20: Connect Lead Wires To Device

    4.3 Connect Lead Wires to Device Before proceeding to this step, be sure the device is completely turned OFF . Insert the wires provided with the system into the jack sockets located on top of the device. Holding the insulated portion of the connector, push the plug end of the wire into one of the jacks (see drawing);...
  • Page 21 4.4.2 Place Electrodes 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.

  • Page 22: Steps To Set A New Program

    alternative stimulation settings and/or electrode placements. Once an acceptable location has been achieved, mark down the electrode sites and the device settings, so the patient can easily continue treatment on their own. 4.5 Turning On the Device 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 (Safety information), as this powerful equipment is neither a toy nor a gadget!
  • Page 23 Step 1: Set the Therapeutic Program There are 4 programs available in TENS therapeutic mode – Burst (B), Normal (N), Pulse Width Modulation (M), and Pulse Rate Modulation (M1). The therapeutic program can be selected by pressing the up [] and down [] button.
  • Page 24 4.7.2 Microcurrent Setting Press the [S] button cycle to enter the setting state. The settings can be adjusted according to the follow steps: Step 1: Set the Therapeutic Program There are 3 available programs in MIC therapeutic program: Constant (N), Pulse Width Modulation (M), and Pulse Rate Modulation (M1).

  • Page 25: Adjust Channel Intensity

    4.8 Adjust Channel Intensity Press the intensity control buttons up [] and down [] to control the intensity output. Slowly press the intensity button control until you reach the setting recommended by your physician or therapist. Repeat for the other channel, if both channels are to be used. CAUTION: 1.

  • Page 26: Turn Off

    CAUTION: Default state, if the button is locked, you can press only one of the down [] buttons to unlock, and then press the [M] button or the down [] button to control stop the treatment. 4.11 Turn Off Press and HOLD the button and for approximately 3 seconds to turn OFF the device.

  • Page 27: Program

    5. PROGRAM Modulation Pulse Treatment Mode Program Frequency Method Width Time 1-60 min; Burst 0.5-5Hz 50-300µs continuous 1-60 min; Continuous 1-150Hz 50-300µs continuous TENS Pulse Width 1-60 min; 1-150Hz 50-300µs Modulation continuous Frequency 1-60 min; 1-150Hz 50-300µs Modulation continuous 1-60 min; Continuous 0.1-150Hz 2-200ms...

  • Page 28: Cleaning And Care

    6. CLEANING AND CARE 6.1 Tips for Skin Care Follow these suggestions to avoid skin irritation, especially if you have sensitive skin: 1. 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.

  • Page 29: Electrodes

    6.3 Electrodes 1. Use this device only with the leads and electrodes provided by the manufacturer. Use only the electrode placements and stimulation settings prescribed by your physician or therapist. 2. It is recommended, at minimum, 1.5” x 1.5” self-adhering electrodes be used at the treatment area.

  • Page 30: Maintenance

    sleeve and insert them into the re-sealable bag and store in a cool dry place. CAUTION: 1. Do not pull on the electrode wire. Doing so may damage the wire and electrode. 2. Do not apply to broken skin. 3. The electrodes should be discarded when they are no longer adhering to the skin.

  • Page 31: Troubleshooting

    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 1.
  • Page 32 3. If still intermittent after replacing the lead wire, a component may have failed. Call the repair department. Some programs will seem intermittent. This is expected. Refer to the Program. Program option in Option Controls in the use. Operation section for a description of the program option.

  • Page 33: Storage

    8. STORAGE 1. 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.

  • Page 34: Electromagnetic Compatibility (Emc) Tables

    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. Electromagnetic environment Emissions Compliance - guidance...
  • Page 35 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. Electromagnetic Compliance IEC 60601 Immunity environment - level test level test...
  • Page 36 Voltage dips, Not applicable Main power quality <5% UT short should be that of a (>95% dip in interruptions UT) for 0.5 typical commercial or and voltage hospital environment. cycle variations on power supply 40% UT input lines (60% dip in UT) for 5 61000-4-11 Cycles...
  • Page 37 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 IEC 60501 Compliance Electromagnetic test test level level environment - guidance...
  • Page 38 Where P is the maximum output power rating of the transmitter In watts (W) according to the. Transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in...
  • Page 39 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...

  • Page 40: Glossary Of Symbols

    11. GLOSSARY OF SYMBOLS Batch code Serial number 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...

  • Page 41: Warranty

    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: 1.
  • Page 42 Manufactured for: Roscoe Medical 21973 Commerce Parkway Strongsville, Ohio 44149 Ph: (800)871-7858 www.roscoemedical.com...

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