Tens AA User Manual

User Manual for TENS AA
PRESCRIBING INFORMATION
FOREWORD
Read this User Manual carefully before you start using your TENS AA.
The manufacturer strongly recommends carefully reading of the “ Warnings and Cautions” and
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WARNINGS AND CAUTIONS
Prescription labeling:
Federal law restricts this device to sale or use by or on the order of a practitioner so licensed by the state.
Contraindications:
1. Do not place the pads on the carotid sinuses
located at the two sides of the neck, (where a doctor feels for a pulse), or over the eyes.
2. Do not use this T.E.N.S. unit if you have a
heart pacemaker or serious heart rhythm problem.
3. Any electrode placement that causes current to flow transcerbrally (through the head).
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4. The use of T.E.N.S. whenever pain syndromes are undiagnosed, until etiology is established.
WARNINGS
WARNINGS
1. Do not use this T.E.N.S. unit during the
pregnancy or at anytime on the abdomen during pregnancy.
2. This T.E.N.S. unit is not effective for pain of
central origin. (Include headache).
3. T.E.N.S. unit should be used only under the
continued supervision of a physician.
4. T.E.N.S. unit has no curative value.
5. T.E.N.S. is a symptomatic treatment and as
such suppresses the sensation of pain, which would otherwise serve as a protective mechanism.
6. The user must keep the device out of the
reach of children.
7. Electronic monitoring equipment may not
operate properly when T.E.N.S. stimulation is in use.
8. Do not use T.E.N.S. unit if you are driving or
operating machinery.
9. If you have epilepsy, consult your doctor
Do not use any pad which size is less than 40mm X 40mm. Allergic reactions to the self-adhesive pads can occur, even though they are hypoallergenic:
Do not apply to broken skin.
Do not apply pads to skin that do not have
normal sensation .If the skin is numb, stimulation will not be felt and too great an intensity might then be used accidentally.
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2. Where applicable place the black adapter
closer to the spinal column; e, g. if the arm is to be treated, place the black adaptor higher up the arm the red adaptor.
GENERAL INFORMATION
Statement: This T.E.N.S. Unit has been tested for EMC requirement according to EN60601-1-2
PADS
The pads that are supplied with your T.E.N.S. Pain Relief Unit are self-adhesive and can be used several times. Skin must be allowed to breathe, so the pads should be removed periodically. periodically. When not in use, the pads should be placed onto the clear plastic shield.
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before using T.E.N.S.
PRECAUTIONS
1. Isolated cases of skin irritation may occur
at the site of electrode placement following long-term application.
2. Effectiveness is highly dependent upon
patient selection by a person qualified in the management of pain patients.
ADVERSE REACTIONS
Skin irritation and electrode burns are potential adverse reactions.
GENERAL WARNINGS
The condition of the pads does affect the conductivity and, therefore, the performance of the unit. When the pads initially lose their adhesive quality, it is possible to reactivate their adhesiveness by applying a fine spray of water. Once the pads have finally lost their adhesive quality, new pads should be purchased.
1. Do not immerse T.E.N.S. units in water.
2. Do not place the T.E.N.S. unit close to
excessive heat.
3. Do not use any pad which size is less than
40mm X 40mm.
4. Use only the specified batteries: 2x 1.5volt
AA Alkaline (LR6). The use of any other battery could damage the unit.
5. Remove batteries if unit is not used for a long period of time.
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6. Do not use the unit while asleep.
7. Keep the unit away from sources of high magnetic fields such as TV’S, microwave ovens and hi-fi speakers, as these may affect the LCD screen.
8. Temperature & R.H. of storage: -20--+80, 8%--
80% R.H.
9. Temperature & R.H. of transportation: -20--+80,
8%--80% R.H.
1,2,3,4,5,10,12,14,16,18,20,25, 30, 35, 40, 50, 60, 70, 80, 90, 100,110,120,130,140,150,
D. Output voltage range
The output voltage of two channels can be adjusted individually in 20 steps. For 500 load, the output The peak pulse output current of two channels can be adjusted individually in 20 steps. For 500 load, the output voltage can be change from 12mA to 150 mA in steps of 7 mA roughly.
E. Peak pulse output current
The peak pulse output current of two channels can be adjusted individually in 20 steps. For 500-ohm load, the output voltage can be change from 12mA to 150mA in steps of 7mA roughly.
RED & BLACK FASTENERS ON LEADS
At the end of the leads supplied with your unit, you will find red and black adapters. these are Cathode and Anode respectively. The following general points are made for your information:
1. More sensation tends to come from the black
adapter(Cathode).
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Amplitude
CONTENTS
Time
(2).Mono-Phasic waveform
Amplitude
Time
B. Pulse duration
Except Mode B, Mode D Mode E, which pulse duration can not be adjusted, by pressing PW+ or PW- key, the pulse width can be adjusted from
50μS to 250μS in step of 10μS
.
C. Pulse frequency
Except M Mode B and Mode E, with a pulse rate, by pressing PR+ or PR- key, the pulse width can be adjusted to one of the following values (Hz):
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Prescribing Information ……………………………1
Contents ……………………………………………5
Operating Instruction for Physician……………….6
Instruction For Use…………………………………6
How to Assemble Your Unit……………………….7
After Use…………………………………………….12
Operation of the T.E.N.S .Unit………..…………..13
Specification………………………………………..17
Features…………………………………………….18
Detail Information…………………………………..22
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OPERATING INSTRUCTIONS FOR PHYSICIAN
INTENDED USE
T. E. N. S. Stands for (Transcutaneous Electrical
Nerve Stimulation). This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
HOW DOES T.E.N.S. WORK
T.E.N.S. is believed to work by stimulating your
body's own natural defenses against pain. The unit produces a gentle stimulus through pads normally placed over the area of pain. This stimulus helps the body to produce natural pain relievers called endorphins.
The correct positioning of the pads is important. Some people feel immediate benefit from T.E.N.S. However some may only achieve benefit after repeated treatment sessions and over an extended period of time.
INSTRUCTIONS FOR USE
5. Two knobs on top of the unit adjust the intensity by turning in clockwise or counter­clockwise.
6. By pressing “PR-”key and “PW-”key
simultmeously, the waveform can be changed in two types.
7. By pressing “timer key”for 2 seconds the
unit will be locked or unlocked in toggle. While the unit is locked, all parameters can not be adjusted except timer and intensity. By pressing ON/OFF key can not change the status of locked/unlocked.
8. When the batteries are low, the symbol of
battery is flashing in 2Hz indicating that the batteries should be replaced.
9. Automatic shut off: When the unit intensity
levels are 0 on both channels, and it has not been in use for 5 minutes, the unit will be shut off automatically.
Detail information regarding to the Waveform, Pulse duration, Pulse frequency, Output voltage range, and Peak pulse output current:
Your T.E.N.S. Pain Relief unit has been designed to be simple and easy to use.
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A. Waveform
There are 2 types of waveforms:
(1). Symmetrical Bi-Phasic rectangular waveform
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100µS in the next 6 seconds. Pulse rate is selectable. Mode E--- Modul II, Pulse rate and Pulse width Modulation. Frequency increase from 50Hz to 100Hz while pulse width decrease from 200µS to 60µS within 5 seconds. Treatment timer: Continuous,15min,30min,45min,60min, 90min selectable.
FEATUERS
1. When mode changes, the intensity will
automatically go down to zero;
2. When the unit is turned on, it will
automatically enter the mode that the unit had worked in before the unit was turned off;
3. When the treatment timer is set, it will
begin to count down one minute by one minute; Once it count down to Zero, the unit will automatically shut off;
4. When the pulse rate, pulse width or
intensity is being adjusted, the auto-repeat function is available, when the key is held down over 1 seconds, it will automatically increased/decreased 1 step per 1/4 seconds.
CONTENT IN THE PACK
Your TENS pack should contain the following:
1 x T.E.N.S. Unit
2 x Leads
4 x Self Adhesive Pads with Connectors
(size: 40mm X 40mm)
2 x Alkaline AA1.54V (LR6) Batteries
1 x Instruction Booklet (which you are
reading)
Having checked all the contents are correct please proceed to assemble the unit.
HOW TO ASSEMBLE YOUR UNIT
Assembly of the TENS AA unit is very simple and requires only five steps.
STEP 1 BATTERIES
Remove the battery cover and insert two batteries, as shown on the diagram inside the battery compartment. Replace the battery cover.
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Note: Your unit will not function if the batteries are inserted incorrectly. To check, press the button once and the LCD display will start up. Having made this check press the button again to switch the unit off.
CAUTION
There is a risk of explosion if the batteries are fitted incorrectly. Replace with AA Alkaline 1.5 volt batteries (LR6). Do not mix old and new
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SPECIFICATION
Model: TENS AA
Channel: Dual
Output: Maximum 150Ma(peak
value)cross 500Ω load
Pulse Width: From 50µS to 250µS adjustable
Pulse Rate: From 1Hz to 150 Hz adjustable
Waveform: Symmetrical Bi-phasic rectangular
Monophasic rectangular
Mode: 5 Modes are available
Mode A---Constant
Mode B---Burst I
Two train per second, 250ms on,
250ms off;
25 pulses within one train, pulse width=200µS
Mode C--- Burst II
Two train per second, 250ms on, 250ms off;
Pulse width and Pulse rate are selectable.
Mode D---Modul I , Pulse width modulation
Pulse width modulated from 100µS to 250µS within 6 seconds and then back to
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.
batteries. Do not dispose of the batteries in a fire and keep them out of reach of children. The batteries must be removed from the unit if unit is not used for a long period of time.
STEP 2 LEADS
Decide whether you wish to use the unit with one lead or two.
If using two leads, insert the plugs into both jacks on the plugs of the unit. If only using one lead, insert into the ch1 jack as marked on the unit.
Please read the following detail specification carefully before using the T.E.N.S. Unit.
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STEP3 PADS
Remove pads from the bag and connect to the leads.
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Turn in counter-clockwise decrease the intensity.
Stands for Pulse Rate Up, press this key to increase the frequency.
Stands for Pulse Rate Down, press this key to decrease the frequency.
Stands for Pulse Width Up, press
t his key to increase the Pulse Width.
Stands for Pulse Width Down, press this key to decrease the Pulse Width.
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Press the key & simultaneously to select the waveform. The following waveform symbols will be displayed for 3 seconds when you press the key.
Symmetrical Bi-phasic rectangular Monophasic rectangular
NOTE
In a very small percentage of people, using T.E.N.S. in Monophasic Rcetangular waveform can exacerbate the symptoms of pain. If this occurs, stop treatment in this waveform in immediately.
STEP 4 PLACEMENT OF PADS
Ensure wherever you intend to place the pads. that the skin is clean and thoroughly dry. remove the pads from the clean plastic shield and position on your body as required.
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Press this key to select mode, total 5 modes are available. Constant, Burst I, Burst II, Modul I, Modul II.
Press this key to set the treatment time.
These two knobs adjust the intensity of channels, left side is for the Ch1, right side is for Ch2. Turn the knob and the intensity over zero, the corresponding LED light located at the top of the knob will light up.
Turn in clockwise increase the intensity.
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STEP 5 READING
Read section on “ Operation of the T.E.N.S. Uint”, and decide how to use the T.E.N.S. uint
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for the treatment.
NOTE: AFTER USE
Always ensure that the unit is switched OFF before removing the pads. After use, return the pads to the clear plastic shields. There is no need to separate the pads unit from the leads and pads.
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Life of the pads: When the pads initially lose their adhesive quality, it is possible to reactivate their adhesiveness by applying fine spray of water. Replace the pads when they lose their
adhesive quality in order not to affect the efficiency of the unit.
OPERATION THE T.E.N.S. UNIT
TENS AA is easy to operate by pressing the key as following diagram.
WHAT DOES EACH KEY DO
This key switches the unit on and off. Press once the unit is on, the LED light (green color) and the LCD display located at the front of the unit will light up, there will be no feeling from either lead at this point as the intensity always starts at zero. Press this key again the unit will switch off.
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