BioMedical Quadstar II Multi Modality Stimulator

More About BioMedical Quadstar II

• Caution:
  - Federal law (USA) restricts this device to sale by or on the order of a physician so licensed by the State which he or she practices. Keep out of reach of children 
• Contraindications:
  - TENS & EMS/NMS devices can adversely affect the operation of demand-type cardiac pacemakers. TENS & EMS/NMS is not recommended for patients with known heart disease without a physician’s evaluation of risk. Do not stimulate over the eyes or carotid sinus nerves as severe spasm of the laryngeal and/or pharyngeal muscles may occur when electrodes are placed over the neck or mouth. (These contractions may be strong enough to close the airway or cause difficulty in breathing.) Do not apply TENS & EMS/ NMS for un-diagnosed pain syndromes until etiology is established. Do not place electrodes in a manner that causes current to flow trans cerebrally (through the head). TENS & EMS/NMS devices should not be applied to malignant tumors. 
• Warnings:
  - This device should be used only under the continued supervision of a physician, or outside the USA, by a qualified pain management specialist. TENS/Interferential stimulation is ineffective for pain of central origin (i.e. appendicitis, hepatitis). TENS/Interferential stimulation is of no curative value; it is a symptomatic treatment which suppresses pain sensation which would otherwise serve as a protective mechanism on the outcome of the clinical process. Safety of TENS/Interferential devices for use during pregnancy or delivery has not been established. For external use only. Electronic equipment such as EKG monitors and EKG alarms may not operate properly when TENS/Interferential Stimulation is in use. This device should not be used over metal implants or sleep apnea monitors.
  - Adequate precaution should be taken when treating patients with suspected heart problems or epilepsy. Caution should be exercised in the trans thoracic application of EMS devices so that the introduction of electrical current into the heart does not cause arrhythmia. The long-term effects of chronic electrical stimulation are unknown.
  - Persistent use of stimulation in the presence of skin irritation may be injurious. Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc. Simultaneous connection to RF surgery equipment can cause a burn. Operation near (e.g. 1m) short wave or micro wave therapy equipment can change the output values of the stimulator.
• Precautions:
  - Skin irritation may occur under electrodes in isolated cases following long-term application. Consult physician if skin irritation develops. The effectiveness of TENS & EMS/NMS/Interferential Stimulation directly depends upon patient selection. Use only for the specific pain problem prescribed by the physician. Do not immerse device in water or other liquids.
  - Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner. Turn the stimulator off before applying or removing electrodes.
  - Powered TENS/EMS/NMS/Interferential devices should be used only with leads and electrodes recommended for use by the manufacturer and should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
  - The device may be affected by electromagnetic interference. Also other electrical equipment in the close vicinity may be affected by the device. If such effects are suspected, either switch off the affected equipment and that suspected of causing the interference, or shorten connecting leads.
  - Precaution should be exercised when stimulation is used:
    1)After recent surgical procedure where muscle contraction may disrupt the healing process
    2)After an acute trauma or fracture where there is a tendency to hemorrhage
    3) Over the menstruating uterus
    4) Where the sensory nerve damage has caused the loss of normal skin sensation
• Adverse Reactions:
  - Possible allergic reaction to tape or gel. Possible skin irritation or electrode burn under electrode. Be sure to follow the instructions of your health professional. If you do have questions or problems make sure you contact them for assistance.

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