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Manufactured for:
Pain Management Technologies
U l t i m a 1 1
Instruction Guide
PADS
The pads that are supplied with your Ultima 11
T.E.N.S. Unit are self-adhesive and can be used several times. Skin must be allowed to breathe, so the pads should be removed periodically. When not in use, the pads should be placed onto the clear plastic shield.
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, newpadsshouldbepurchased.
WARNINGS
Do not use any pad which size is less than
40mmX 40mm.
Allergic reactions to the self-adhesive pads canoccur, eventhoughtheyarehypoallergenic:
· Donot apply tobrokenskin.
· 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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to 73V in steps of 3.5V 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 from12mA to150mAinstepsof 7mAroughly.
RED&BLACKFASTENERS ONLEADS
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).
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 armthan the red adaptor.
GENERAL INFORMATION
Statement: This T.E.N.S. Unit has been tested for EMC requirement according to EN
60601-1-2
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UserManualforUltima11T.E.N.S.UNIT
PRESCRIBINGINFORMATION
FOREWORD
Read this User Manual carefully before you start usingyour Ultima11T.E.N.S. unit.
The manufacturer strongly recommends carefully reading of the “Warnings and Cautions” and
Chaptersof thisUserManual.
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 toflowtranscerbrally(throughthehead).
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4.
Theuseof T.E.N.S. whenever painsyndromes areundiagnosed, until etiologyisestablished.
WARNINGS
1.
Do not use this T.E.N.S. unit during the pregnancy or at anytime on the abdomen duringpregnancy.
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 isinuse.
8.
Do not use T.E.N.S. unit if you are driving or operating machinery.
9.
If you have epilepsy, consult your doctor
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(3). Mono-Phasic rectangular waveform
A m p A l i t u d e
Time
B. Pulse duration
Except Mode B, Mode D and Mode E, which pulse duration can not be adjusted, by pressing
PW+ or PW- key, the pulse width can be adjusted from50μSto250μSinstepsof 10μS.
C. Pulse frequency
Except Mode B and Mode E with a fixed pulse rate, by pressing PR+ or PR- key, the pulse rate can be adjusted to one of the following values (Hz):
1,2,3,4,5,10,12,14,16,18,20,25,
30,35,40,45,50,60,70,80,90,
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-ohm load, the output voltage can be changed from6V
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16. 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:
A. Waveform
There are 3 types of waveforms:
(1). Symmetrical Bi-Phasicrectangular waveform
A m p A l i t u d e
Time
(2). Asymmetrical Bi-Phasicrectangular waveform
A m p A l i t u d e
T i m e
2 2 before using T.E.N.S.
PRECAUTIONS
1.
Isolated cases of skin irritation may occur at the site of electrode placement following long-termapplication.
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
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 40mmX 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 LCDscreen.
8. Temperature & R.H. of storage: -20℃--+80
℃
, 8%--80%R.H.
9. Temperature & R.H. of transportation: -20
℃
--+80℃, 8%--80%R.H.
4 the polarity of the symmetrical bi-phasic rectangular and mono-phasic rectangular waveformisreversed, andthecorresponding symbol is flashed.
12.
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.
13.
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 second, it will automatically increase/decrease 1 step per 1/4 second.
14.
By pressing“waveformkey”and“Ch2 down” key simultaneously for 2 seconds, the unit will be “ Doctor-locked” or
“
Doctor-unlocked” in toggle. While the unit is “Doctor-locked”, all parameters cannot be adjusted except timer and intensity but also the mode cannot be changed. By removing batteries or pressing ON/OFF key cannot change the status of Doctor-locked/Doctor-unlocked.
15.
When one or both of the electrodes does not touch the skin or it is opened, the output level of the corresponding channel will go immediately down to zero (this feature is limited to the model Ultima 11).
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cannot changethestatusof locked/unlocked.
6.
The treatment time will be accumulative recorded when the output level is above zero, by pressing“ch2 down”key and
“ timer”key for 2 seconds the treatment time accumulated in minute can be displayed, or return back to the previous normal display in toggle; by pressing
“ mode”key & timer”key for 2 seconds will clear the treatment time to zero.
7.
When the batteries are low, the symbol of battery is flashing in 2 Hz indicating that the batteries should be replaced.
8.
Symbols A - B - C will show the passed phase (if permanently ON) of the programs
Acute Pain and Chronic Pain.
9.
Symbols Hz or/and μS will flash when the respective shown value is different from the Default. Whenever the M key is pressedfor 2seconds, thedefault parameters of the current mode can be recovered; when the unit is in locked mode, the
Default value will not be restored.
10.
By pressing the waveform key, the form of the stimulation wave is changed and the change is directly felt by the user.
11.
By pressing the waveformkey for 2 seconds
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CONTENTS
Prescribing Information
Contents
Operating Instruction for Physician
Instruction For Use
Howto Assemble Your Unit
After Use
Operation of the T.E.N.S. Unit
Specification
Features
General Information
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OPERATINGINSTRUCTIONSFORPHYSICIAN
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.
HOWDOES T.E.N.S. WORK
T.E.N.S. is believed to work by stimulating your body'sownnatural defensesagainst 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
Your Ultima 11 T.E.N.S. Pain Relief unit has been designed to be simple and easy to use.
6 the completed phase.
Acute Pain (Preset) —Both Pulse-Rate and
Pulse-Width are preset to apply a sequence of 3 programs ( A , B , C ), optimized to treat the Acute pain.
Treatment timer: Continuous, 15min, 30min, 45min,
60min, 90min selectable.
FEATURES
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 hadworkedinbeforetheunit wasturnedoff.
3.
Symbols MANUAL and PRESET, on the
LCD display, will switch-on according the program.
4. Symbols Gate Control and Endorphins will show automatically if Gate Control or
Endorphins techniques are applied.
5. By pressing “waveform” key and “Ch1 down” keysimultaneouslyfor 2seconds, 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 removing batteries or pressing ON/OFF key
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1s on, 2s off. Both Pulse Rate and Pulse Width will be freely adjustable.
Burst 2 — One train any 1.5 seconds, 0.5s
on, 1s off. Both Pulse Rate and Pulse Width will be freely adjustable.
Burst 3 — One train any 0.75 seconds, 0.25s
on, 0.5s off. Both Pulse Rate and pulse Width will be freely adjustable.
Modulation SW — Pulse Rate Sweep Modulation.
Pulse Rate is automatically modulated within a basic frequency F1=5Hz and F2=20Hz (adjustable from1to150Hz).
Modulation 2F — Pulse Rate Dual Frequencies
Modulation. Pulse Rate is automatically changed, any 5 seconds, between F1=70Hz (adjustable) andF2=5Hz.
Modulation SW (Preset) — Frequency & Pulse
Rate Sweep Modulation. Frequency increases from 50Hz to 100Hz while pulse width decrease from200μSto50μS, within5seconds.
Chronic Pain (Preset) — Both Pulse - Rate and
Pulse - Width are preset to apply a sequence of 3 programs ( A , B , C ), optimized to treat the chronicpain.
The symbols A , B or C will flash, showing the phase in use of will be ONto showthe completed phase.
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CONTENT IN THE PACK
Your T.E.N.S. packshouldcontainthefollowing:
· 1x T.E.N.S. Unit
· 2x Leads
· 4 x Self Adhesive Pads with Connectors
(size: 40mmX 40mm)
· 2x AlkalineAA1.5V(LR6) Batteries
· 1xInstructionBooklet (whichyouarereading)
Having checked all the contents are correct please proceed to assemble the unit.
HOWTOASSEMBLE YOUR UNIT
Assembly of the Ultima 11 T.E.N.S. Pain Relief unit is very simple and requires only five steps.
STEP 1 BATTERIES
Removethebatterycover andinsert twobatteries, as shown on the diagram inside the battery compartment. Replace the battery cover.
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EasyMed
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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: Ultima 11
Channel:
Output:
Dual
Maximum 130mA (peak value) cross 500 Ohmload
PulseWidth: From50μSto250μSadjustable
Pulse Rate: From1Hz to 150Hz Adjustable
Waveform: Symmetrical Bi-phasicrectangular
Asymmetrical Bi-phasicrectangular
Mode:
Monophasic rectangular
11 Modes are available
Constant 1 — Both Pulse Rate and pulse Width will be freely adjustable. Default values are
PR=3HzandPW=250μS.
Constant 2 — Both Pulse Rate and pulse Width will be freely adjustable. Default values are
PR=20Hz and PW=150μS.
Constant 3 — Both Pulse Rate and pulse Width will be freely adjustable. Default values are
PR=70Hz and PW=50μS.
Burst 1 — Onetrainany3seconds,
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US
BURST II
Ch1 min
Ultima 11
Ch2
PR+
PR-
M
PW+
PW-
L E D l i g h t
O n / O f f
W a v e f o r m
1 1 m o d e s a r e available for selection
Timer for Treatment
C o n t i n u o u s
15/30/45/60/90 min
S e l e c t a b l e
Intensity Up Ch1
Pulse Rate Up
Pulse Width Up
Intensity Up Ch2
Intensity Down Ch1
Pulse Rate Down
Pulse Width Down
Intensity Down Ch2
Please read the following detail specification carefully before using the T.E.N.S. Unit.
1 6 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.
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US
BURST II
Ch1 min
EasyMed
R
Ch2
PR+
PR-
M
PW+
PW-
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STEP 3 PADS
Remove pads fromthe bag and connect to the leads.
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PR+
PR-
Press this key to set the treatment time.
Press this key to adjust the intensity of every channel, left side is for the ch1, right side is for ch2--increase the intensity.--decrease the intenstity.
Stands for Pulse Rate Up, press this key to increase the frequency.
Stands for Pulse Rate Down, press this key to decrease the frequency.
PW+
Stands for Pulse Width Up, press this key to increase the Pulse Width.
PW-
Stands for Pulse Width Down, press this key to decrease the Pulse Width.
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Press the key respectively to select the waveform. The following wavefrom symbols will be displayed for 2 seconds whenyoupressthekey.
Symmetrical Bi-phasicrectangular
Asymmectrical Bi-phasicrectangular
Monophasic rectangular
NOTE
In a very small percentage of people, using
T.E.N.S. in Monophasic Rectangular waveform can exacerbate the symptoms of pain. If this occurs, stoptreatment inthiswaveformimmediately.
M
Press this key to select mode, total 11 modes are available:
- Constant 1
- Constant 2
- Constant 3
- Burst 1
- Burst 2
- Burst 3
- Modulation SW
- Modulation 2F
- Modulation SW
- Chronic Pain
- Acute Pain
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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 clear plastic shield and position on your body as required.
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STEP 5 READING
Read section on“Operation of the T.E.N.S.
Unit”, and decide howto use the T.E.N.S. unit
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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 adhesivequality, it ispossibletoreactivate their adhesiveness by applying fine spray of water. Replacethepadswhentheylosetheir
1 2 adhesive quality in order not to affect the efficiency of the unit.
OPERATION OF THE T.E.N.S. UNIT
Ultima 11 T.E.N.S.Unit is easy to operate by pressing the key as following diagram.
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M
PR+
PR-
PW+
PW-
WHAT DOES EACH KEY DO
This key switches the unit on and off.
Press once and 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 and the unit will switch off.
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