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Contraindications, Warnings, Precautions, Advserse Reactions for NMES & TENS

Contraindications for NMES:

  • Powered muscle stimulators should not be used on patients with cardiac demand pacemakers/defibrillators.

Warnings for NMES:

  • The long-term effects of chronic electrical stimulation are unknown;
  • Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex;
  • Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing;
  • Stimulation should not be applied transthoracically, in that the introduction of electrical current into the heart may cause cardiac arrhythmias;
  • Stimulation should not be applied transcerebrally;
  • Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc; and
  • Stimulation should not be applied over, or in proximity to, cancerous lesions.

Precautions for NMES:

  • If in doubt, always seek medical advice;
  • Medical advice must be obtained before use on persons who are insulin-dependent diabetics or for persons who are under medical supervision for any cognitive dysfunction;
  • Medical opinion must be obtained before persons with any serious illness or injury apply muscle stimulation;
  • Powered muscle stimulators should be kept out of the reach of children;
  • The safety of powered muscle stimulators for use during pregnancy has not been established;
  • Caution should be used for patients with suspected or diagnosed heart problems;
  • Caution should be used for patients with suspected or diagnosed epilepsy;
  • Caution should be used in the presence of the following:
    • When there is a tendency to hemorrhage following acute trauma or fracture;
    • Following recent surgical procedures when muscle contraction may disrupt the healing process;
    • Over the menstruating or pregnant uterus;
    • Over areas of the skin which lack normal sensation.
  • Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium gel;
  • Stimulation settings should be based on the guidance of the prescribing practitioner;
  • Powered muscle stimulators should be used only with the leads and conductive gel pads recommended for use by the manufacturer;
  • Portable powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk or injury;
  • Operation in close proximity to shortwave or microwave therapy equipment may produce instability in the stimulator output;
  • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when the stimulator is in use.
  • Although compliant with applicable EMC requirements, this device may still interfere with more sensitive equipment, please move away or switch off;
  • Discontinue using the device following knee surgery if you experience any of the following adverse reactions: rotational trauma or hamstring strain during leisure time activities/sports, spasms of the quadriceps muscle, excessive post-operative swelling, redness and an evidence for haemorrhage; and
  • In clinical tests of Kneehab XP post ACL surgery, patients with the following conditions were excluded: multi-ligament construction, additional meniscectomy, quadriceps tendon graft, cartilage damage greater than grade II, micro-fracture of the knee. Accordingly, safety and efficacy of the device with these patients has not been demonstrated.

Adverse Reaction for NMES:

  • Skin irritation and burns beneath the conductive gel pads have been reported with the use of powered muscle stimulators. Contact your prescribing physician, or Neurotech if any irritation, skin reaction, hypersensitivity or other adverse reaction is experienced and discontinue using in the meantime. Note, however, that a slight reddening of the skin is quite normal under the conductive gel pads during and for a short time after treatment.
  • Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device.

Contraindications for TENS:

  • Do not use this device on patients whose pain syndromes are undiagnosed; and
  • Patients with electronic implants (e.g. cardiac pacemaker or defibrillator - as your product may interfere with the proper functioning of the implanted stimulator) or if you suffer from any other heart problem.

Warnings for TENS:

  • Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use;
  • Do not apply stimulation when the patient is in the bath or shower;
  • Do not apply stimulation while the patient is sleeping, unless the Controller keylock feature has been engaged;
  • Do not apply stimulation while the patient is driving, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury;
  • Consult with the patient’s physician before using this device, because the device may cause lethal rhythm disturbances to the heart in susceptible individuals;
  • Apply stimulation only to normal, intact, clean, healthy skin;
  • The long-term effects of chronic electrical stimulation are unknown;
  • Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex;
  • Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing;
  • Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias;
  • Stimulation should not be applied transcerebrally;
  • Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc; and
  • Stimulation should not be applied over, or in proximity to, cancerous lesions.

Precautions for TENS:

  • TENS is not effective for pain of central origin, including headache;
  • TENS is not a substitute for pain medications and other pain management therapies;
  • TENS is a symptomatic treatment and, as such, suppresses the sensation of pain that would otherwise serve as a protective mechanism;
  • Effectiveness is highly dependent upon patient selection by a practitioner qualified in the management of pain patients;
  • Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the head, and electrodes should not be placed on opposite sides of the head;
  • The safety of electrical stimulation during pregnancy has not been established;
  • Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians; and
  • Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians;
  • Use caution when the patient has a tendency to bleed internally, such as following an injury or fracture;
  • Use caution following recent surgical procedures when stimulation may disrupt the patient’s healing process;
  • Use caution if stimulation is applied over the menstruating or pregnant uterus;
  • Use caution if stimulation is applied over areas of skin that lack normal sensation;
  • Keep this device out of the reach of children;
  • Use this device only with the leads, electrodes, and accessories recommended by the manufacturer; and
  • Use this device only under the continued supervision of a licensed practitioner.

Adverse Reaction for TENS:

  • Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin;
  • Patients may experience headache and other painful sensations during or following the application of electrical stimulation near the eyes and to the head and face; and
  • Patients should stop using the device and should consult with their physicians if they experience adverse reactions from the device.
Kneehab XP®
Quadriceps Strengthening