Richmar InTENSity 7, Instruction Manual

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9. Isolated cases of skin irritation may occur at the site of electrode
placement following long term application. If this occurs,
discontinue use and consult your physician.
10. If TENS therapy becomes ineffective or unpleasant, stimulation
should be discontinued until its use is re-evaluated by a physician.
11. Keep this device out of the reach of children.
12. InTENSity 7 devices have no AP/APG protection. Do not use it
in the presence of explosive atmosphere and flammable mixture.
13. It is recommended not to exceed a current density of
2 mA /cm2,otherwise skin irritations or burns can occur.
We recommend that:
• Please use specific size electrodes provided by manufacturer
to avoid skin irritations or burns.
• For smaller electrodes, the maximum current setting of the
waveform should be appropriately reduced.
• Please place the electrodes carefully, ensure that the entire
surface of the electrode has good contact with the skin.
14. TENS devices have no curative value.
15. TENS is a symptomatic treatment, and as such suppresses the
sensation of pain, which would otherwise serve as a protective
mechanism.
16. TENS is not effective for pain of central origin (This includes
headache).
17. Electronic monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when TENS stimulation is in use.
18. Caution should be used in applying TENS to patients suspected of
having heart disease. Further clinical data is needed to show there
are no adverse results.
19. Electrodes should not be placed over the eyes, in the mouth,
from the chest and the upper back or crossing over the heart,
or internally.
20. DO NOT use while sleeping.
21. DO NOT use during pregnancy unless directed by your physician.
22. Simultaneous connection of a PATIENT to a high frequency
surgical device may result in burns at the site of the STIMULATOR
electrodes and possible damage to the STIMULATOR.
23. Operation in close proximity to a shortwave or microwave therapy
device may produce instability in the STIMULATOR output.
24. DO NOT insert the plug of the patient lead wire into any AC power
supply outlet.
25. NEVER apply electrodes over irritated or broken skin.
26. DO NOT use TENS over the carotid sinus (neck) region.
27. TENS devices can affect the operation of demand type cardiac
pacemakers.
28. DO NOT use TENS device if you have heart disease without
consulting your physician.
29. DO NOT stimulate on the site that may cause current to flow
transcerebrally (through the head).
30. DO NOT apply TENS for underdiagnosed pain syndromes
until etiology is established.
31. DO NOT insert the plug of the patient lead wire into any AC power
supply socket.
Chapter 4: CONTRAINDICATIONS
1. DO NOT use TENS over the carotid sinus (neck) region.
2. TENS devices can affect the operation of demand type cardiac
pacemakers.
3. DO NOT use TENS device if you have heart disease without
consulting your physician.
4. DO NOT stimulate on the site that may cause current to flow
transcerebrally (through the head).
5. DO NOT apply TENS for underdiagnosed pain syndromes until
etiology is established.
Chapter 5: ADVERSE REACTIONS
Skin irritation and electrode burns are potential adverse reactions.
If skin irritation occurs, discontinue use and consult your physician.
Chapter 6: GENERAL DESCRIPTION
The InTENSity 7 is a battery operated pulse generator that sends
electrical impulses through electrodes to the body and reaches nerves
causing pain. The device is provided with two controllable output
channels, each independent of each other. An electrode pair can be
connected to each output channel.
The electronics of the InTENSity 7 create electrical impulses whose
intensity, duration, number per second and modulation may be altered
with the controls / switches. Press buttons are very easy to use and
the large liquid crystal display showing the exact mode and values of
parameters are very convenient for patients.