4
Be aware !
1.
Consult your physician before using this device. The stimulation with the device may:
i. cause lethal rhythm disturbances to the heart in susceptible individuals, and,
ii. disrupt the healing process after a recent surgical procedure.
2.
The device is not effective for pain of central origin (i.e. appendicitis, Hepatitis), including
headache.
3.
The device is not a substitute for pain medications and other pain management therapies.
4.
The device has no curative value.
5.
The device is a symptomatic treatment and, as such, suppresses the sensation of pain
that would otherwise serve as a protective mechanism.
6.
The long-term effects of electrical stimulation are unknown.
7.
The user may experience skin irritation, burns or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).
8.
If the user has suspected or diagnosed epilepsy, the user should follow precautions
recommended by his or her physician.
9.
Use caution if the user had a tendency to bleed internally, such as following an injury or
fracture.
10. Use caution if stimulation is applied over the menstruating uterus.
11. Use caution if stimulation is applied over areas of skin that lack normal sensation.
12. Stop using the device if the device does not provide pain relief.
13. Use this device only with the wires, electrodes, and accessories that the manufacturer
recommends.
14. Patient is intended operator.
15.
Effectiveness is highly dependent upon patient selection by a practitioner qualified in the
management of pain patients.
16. 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.
17. Do not use the stimulator near an MRI environment.
Medical Electrical Equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the
EMC information provided. Portable and mobile radio frequency (RF) communication
equipment can affect Medical Electrical Equipment.
Summary of Contents for MDTS100
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