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TensMed 911
User Manual

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Summary of Contents for Enraf Nonius TensMed 911

  • Page 1 TensMed 911 User Manual...
  • Page 2 Copyright: Enraf-Nonius B.V. P.O. Box 12080 3004 GB Rotterdam The Netherlands Tel: +31 (0) 10– 20 30 600 Fax: +31 (0) 10– 20 30 699 info@enraf-nonius.com www.enraf-nonius.com Part number: 1427.755-41 August 2005...
  • Page 3 TensMed 911 User Manual 1ÿ...
  • Page 4: Table Of Contents

    Table of Content Product Description..................3 Foreword ......................3 This manual .........................3 Product liability........................3 Limitations of liability......................3 Precautionary Instructions ................4 Intended Purpose....................5 Pain Management (TENS)....................5 4.1.1 Indications/Contraindications and Adverse Effects for Pain Management......5 4.1.2 Current Waveform ........................ 5 Package Contents.....................6 Standard Accessories ......................6 Optional Accessories ......................6 Installation......................6 Application of Electrodes.................7...
  • Page 5: Product Description

    With manual operation the channels are linked, the current amplitude can be set individually on each channel. WARNING (USA only): The TensMed 911 is a prescription device that should only be used under the supervision or by the order of a physician or other licensed healthcare provider.
  • Page 6: Precautionary Instructions

    3 Precautionary Instructions In this section general Warnings and Precautions are listed, that you should be aware of when using the TensMed 911. See also chapter 4 for Warnings and Precautions, that apply to Muscle Stimulation applications in particular. WARNING: •...
  • Page 7: Intended Purpose

    4.1.2 Current Waveform For pain management the TensMed 911 offers the asymmetrical biphasic pulsed current waveform, which is often used in TENS (Transcutaneous Electrical Nerve Stimulation) applications. This waveform is an alternating current, characterized by variable phase duration and a variable pulse frequency. Its typical characteristics amplitude, phase duration, and rate of rise and decay are unequal for each phase with respect to the baseline.
  • Page 8: Package Contents

    TENS waveform it is easier to exceed the motorial threshold stimulus. 5 Package Contents 1427940 TensMed 911 Standard Accessories The following accessories are included with your TensMed 911: 3444001 Electrode cable 2 mm, 2 pc in conformity with FDA CFR 898 3444057 EN-Trodes, self adhesive electrode 50x50 mm, 1 set 4 pc.
  • Page 9: Application Of Electrodes

    NOTE: • The description below applies to electrotherapy applications in general. The electrolytic effects mentioned do not apply to the Tensmed 911 as this device only generates fully balanced TENS currents, that do not contain a DC component. Before treatment •...
  • Page 10: Operating Instructions

    8 Operating Instructions Operator Controls On / off button. When the unit is switched on the yellow LED at the front of the unit will light and a single beep will sound. Output intensity starts at zero. The unit starts at the last program and/or manual setting used. When the unit is switched off the LED will go out and two beeps will sound.
  • Page 11: Intensity Adjustment

    Intensity adjustment The TensMed 911 has an intelligent intensity adjustment to minimise delay in waiting for the next work period, and to avoid confusing the sensation from the two channels. When either intensity button is pressed, the work/rest cycle is interrupted, and the other channel intensity drops to zero.
  • Page 12: Programs

    Press Menu key to confirm setting and exit. Doctor Locking The TensMed 911 has two levels of Doctor Locking: 8.7.1 Program Locking The TensMed 911 may be set so that patient access is restricted to one program, allowing change of Intensity and Timer only.
  • Page 13: User Maintenance

    8.7.2 Manual Program Locking The TensMed 911 may also be set to give the patient two customised programs to access according to your instructions. Once parameters for manual programs G & H have been set, they can be protected from further change by pressing MENU and CH2 INTENSITY DOWN keys together and holding for 4 seconds.
  • Page 14: Stimulator Output Parameters

    9 Stimulator Output Parameters Wave form Biphasic asymmetrical TENS Pulse Width 50, 100, 150, 200 and 250 µs Pulse frequency 1, 2, 3, 4, 5, 10, 12, 14, 16, 18, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140 and 150 Hz Frequency modulation Program I, 20Hz to 100 Hz and back in 12 seconds...
  • Page 15: Technical Specifications

    11 Technical Specifications : This equipment complies with all requirements of the Medical Device Directive (93/42/EEC). Medical device classification : IIa Safety tests : according to IEC 60601-1 +A1 +A2 and IEC 60601-2-10 +A1, Safety class according to IEC 60601-1 : type BF Dimensions : 144 x 80 x 27,5 mm (h x w x d)

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