med-fit EM6100A Premier TENS Stimulator TENS Machine User Manual
- June 11, 2024
- med-fit
Table of Contents
EM6100A Premier TENS Stimulator TENS Machine
Product Information: Med-Fit Pain Relief Premier TENS
Stimulator TENS Machine EM6100A
The Med-Fit Pain Relief Premier TENS Stimulator TENS Machine
EM6100A is a medical-grade device that uses advanced technology to
provide pain relief. It comes with four packs of self-adhesive
electrodes, patient cables, a charger, and a USB cable. The device
is fully tested to ensure high quality and reliability.
The Premier range of stimulators uses soft touch control
technology, which increases the intensity of the stimulation in 1mA
increments (up to a maximum of 99mA) with each press of the button.
This safety feature ensures that the stimulation is comfortable and
pleasant for the user.
The device has various programmes (P1-P12) and manual
adjustments that allow the user to customize their treatment
according to their needs. The device also comes with a user manual
that provides detailed instructions on how to use it safely and
effectively.
Product Usage Instructions
-
Before using the TENS machine for the first time, fully charge
the battery using the charger and USB cable provided. Refer to page
7 of the user manual for charging instructions. -
To switch on the TENS machine, press and hold down the On/Off
button located at the bottom left-hand corner of the device for 2
seconds. -
To choose between programme mode and manual mode, press the
Mode button located on the device’s left-hand side. We recommend
starting with a pre-set programme (P1-P12) before using manual
mode. -
To select a programme, use the arrow keys located below the Set
button. Refer to pages 13-14 of the user manual for detailed
information on each programme. -
The recommended programme for first-time TENS treatment is
programme P1, which provides a gentle TENS treatment with a good
pain-blocking effect and serves as an introduction to TENS
stimulation. -
When using manual mode, use the Set button to select the
desired parameters. -
To increase the intensity of the stimulation, press the
Intensity Up button for the desired channel. Similarly, to decrease
the intensity, press the Intensity Down button for the desired
channel. -
When increasing the intensity, use single light touch actions
to press the button. Each press increases the intensity by 1mA (max
99mA). This is a safety feature that ensures the stimulation is
comfortable and pleasant for the user. -
Refer to pages 20-21 of the user manual for helpful tips on
electrode placement and usage. -
Refer to page 26 of the user manual for information on how to
perform a skin patch test before using the device.
Med-Fit Pain Relief
Premier TENS Stimulator TENS Machine
EM6100A
med fit
Patient Instruction & User Manual
Tel: 0161 429 7330 email: [email protected]
med fit
Thank you for purchasing a Premier Range Stimulator. These devices are
manufactured to the highest of medical standards using the latest and most
advanced technology. Each unit is fully tested in final assembly and
inspection ensuring you receive the highest quality and an extremely reliable
device.
Important information Please read the following instructions
The Premier range of stimulators use soft touch control technology. When
increasing the intensity control, please press the button in single “light
touch” actions. Each press increases the intensity by 1mA (max 99mA). This is
a safety feature which ensures that you stimulate at a pleasant comfortable
rate.
Contents: 1 x Premier TENS Unit 1 x Charger and USB Cable 4 x Packs of Self-
Adhesive Electrodes ( 4 electrodes per pack) 1 x Pair of Patient Cables 1 x
User Manual
Med-Fit UK Ltd. Unit 8 Martel Court S. Park Business Park Hamilton Road
Stockport SK1 2AF.
Tel: 0161 429 7330 Fax: 0161 427 0215
Email: [email protected] www.tensmachineuk.com
Company registration number 08758741 Vat registration number 308 286 105
3
Contents
CONTROLS AND FUNCTIONS
4
STEP BY STEP GUIDE
5
CHARGING INSTRUCTIONS
7
WARNINGS AND CAUTIONS
8
GENERAL DESCRIPTION
10
INTRODUCTION TO TENS
10
WHICH PROGRAMME SHOULD I USE
12
HOW HIGH SHOULD I TURN THE INTENSITY
12
THE PREMIER PLUS TENS PROGRAMMES P1 – P12
13
MANUAL ADJUSTMENTS
16
HELPFUL TIPS
20
TENS ELECTRODE PLACEMENT
21
WARRANTY
26
SKIN PATCH TEST
26
ELECTRODE INSTRUCTIONS
27
TECHNICAL SPECIFICATION
28
EMC INFORMATION
32
4
CONTROLS AND FUNCTIONS
Left channel socket
Red key lock button Mode display for both programmes and manual mode Mode
button select programme mode or manual adjustments
Intensity up channel 1
Intensity down channel 1
On / Off Button
Right channel socket
Intensity display for channel 1 and 2 Charging port
Timer Indicator
The time can only be adjusted in manual mode, time is set to continuous on all
programmes
Intensity up channel 2
Intensity down channel 2
Programme selector up and down
LED charging indicator
The set button is to select the desire parameters in manual mode only it has no function when using the pre-set programmes.
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5
STEP BY STEP GUIDE
Before using your premier TENS for the first time, please fully charge the
battery see page 7.
Press the
button to switch on the TENS. This is located at the bottom
left hand corner of the TENS device. Please push and hold down the button for
2 seconds to turn the unit on.
Pressing the MODE button will allow you to change from programme mode to manual mode. Before using manual mode, we recommend starting with a pre-set programme (P1-P12).
<
To change the programmes please use the arrow keys directly below the set button this will allow you to choose the required programme.
<
Please refer to the programme information supplied (please see pages 13 to 14
for programme details).
The recommended programme to use for the first time TENS treatment is
programme P1. This is a gentle TENS treatment with a good pain-blocking effect
and is an introduction to TENS stimulation.
You are now ready to use the TENS for the first time. (see step 8).
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6
STEP BY STEP GUIDE
Connect one of the TENS lead cables supplied to the top of your TENS machine.
As shown in Fig1. Now connect the other end of the TENS cable to the self-
adhesive electrodes supplied. As shown in Fig2.
Fig1
CH1
CH2
CH1
CH2
CH1 = Channel 1 CH2 = Channel 2
Next place the self-adhesive electrodes on to the painful site or as recommended by your healthcare professional. You are now ready to turn up the intensity on your TENS machine.
You must use two self adhesive pads connected to one cable for the TENS to work. Please keep a 2.5cm gap between the pads.
Fig2
7
3 When connecting the
leads, ensure they are inserted straight not at an angle.
The intensity keys on your TENS are marked CH1 and CH2. To increase the intensity press the up arrow key, each press increases the intensity by 1mA and is
CH1
CH2
MODE
displayed in the screen. It is recommended that you
SET
increase the intensity to a sensation which is comfortable
<
and not too strong. As you use the TENS for longer
periods it may be necessary to increase the intensity to
<
higher levels. To control your pain more effectively.
It is recommended the first treatment should be a minimum
of 1 hour to 11/2 hours to give the best possible results.
Telephone: 0161 429 7330
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7
CHARGING INSTRUCTIONS
Important information The USB charging cable connects to the TENS charging
port as shown in fig 1 (Please ensure you connect the cable the right way
round).
fig1
Charging Port
The lead fits one way round please check
When the battery has 10% charge, a low battery indicator will appear on the screen.
LED indicator
Before using your Premier TENS Stimulator please charge the unit, as follows:
Charging your TENS device.
Connect the USB cable to the AC adaptor or USB port as shown in figure 1.
Now connect the USB cable directly into the USB socket, which is located on
the right hand side of your Premier TENS.
A red indicating light will be seen in the bottom right hand corner of your
TENS device. We recommend you charge the device for approximately 2 hours.
Once fully charged the unit will be ready for use and the LED charging light
will turn to green, this indicates the unit is fully charged. Remove the USB
charging lead from your TENS device and disconnect from the mains supply or
USB port. Please store your adaptor and cable in the carry case provided when
not in use.
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Telephone: 0161 429 7330
8
WARNINGS & PRECAUTIONS
PLEASE NOTE: Patients must read and understand the warnings and precautions
before using this device. Do not allow your machine or electrodes to be used
by anyone else, as they are designed for single patient use only. It is
recommended that proper medical advice on the use of TENS is sought from a
Qualified Practitioner (Physiotherapist, Doctor or Nurse) before use, to
ensure safe and effective treatment. If you are taking any medication please
carry on as normal but seek advice from your Doctor/Healthcare Professional
before using the device.
WARNING! PATIENTS WITH PACEMAKERS MAY NOT BE TREATED WITH TENS · Do Not use
during pregnancy except during labour
(under medical supervision) · Do Not place electrodes over the Carotid Sinus ·
Do Not use on broken or damaged skin · Do Not place electrodes close to the
eyes or in the mouth. · Do Not use TENS whilst driving or operating machinery.
TENS is unsuitable and should not be used in the following situations. ·
Persons suffering from conditions where the circulation is impaired. ·
Epilepsy, Heart Condition or any form of Malignancy. · Patients with poor skin
sensation and non-compliant patients who are emotionally
disturbed or have dementia. · Over metal implants or in conjunction with sleep
apnea or heart monitors. You should be aware that TENS units provide
symptomatic relief only and are not considered curative.
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9
WARNINGS
1. The long term effects of chronic electrical stimulation are unknown. 2.
Stimulation should not be applied over the carotid sinus nerves, particularly
in patients with a known
sensitivity to the carotid sinus reflex. 3. Stimulation should not be applied
over the neck or mouth. Severe spasm of the laryngeal and pharyngeal
muscles may occur and the contractions may be strong enough to close the
airway or cause difficulty in breathing. 4. Stimulation should not be applied
transthoracically in that the introduction of electrical current into the
heart may cause cardiac arrhythmias. 5. Stimulation should not be applied
transcerebrally 6. Stimulation should not be applied over swollen, infected,
inflamed areas or skin eruptions, eg, phlebitis, thrombophlebitis, varicose
veins etc. 7. Stimulation should not be applied over or in proximity to
cancerous lesions.
Contraindication
Electrical stimulators should not be used on patients with cardiac demand
pacemakers.
Adverse Reactions
On rare occasions skin irritation and burns beneath the electrodes have been
reported with the use of electrical stimulators. If irritation occurs,
discontinue use and consult your Healthcare Professional.
CAUTIONS
1. Safety of powered muscle stimulators for use during pregnancy has not been
established. 2. Caution should be used for patients with suspected or
diagnosed heart problems. 3. Caution should be used in the presence of the
following: a. When there is a tendency to haemorrhage following acute trauma
or fracture; b. Following recent surgical procedures when muscle contraction
may disrupt the healing process; c. Over the menstruating or pregnant uterus;
and d. Over areas of the skin which lack normal sensation. 4. Some patients
may experience skin irritation or hypersensitivity due to electrical
stimulation or electrical
conductive medium. Using an alternate conductive medium, or alternate
electrode placement can usually reduce the irritation. 5. Electrode placement
and stimulation settings should be based on the guidance of the prescribing
practitioner. 6. Powered muscle stimulators should be kept out of the reach of
children. 7. Powered muscle stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer. 8. Portable powered muscle
stimulators 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.
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Telephone: 0161 429 7330
10
GENERAL DESCRIPTION
The EM6100A Digital TENS is a battery operated pulse generator that sends
electrical impulses electrodes to the body. The TENS unit uses mild, safe
electrical signals to help control pain and delivers the electrical signal to
the body through a connection of a lead wire and self adhesive conductive
electrode. An electrode pair can be connected to each output channel. The
intensity level is controlled by press buttons.
INTRODUCTION TO TENS
EXPLANATION OF PAIN
Pain is a warning system and the body ‘s method of telling us that something
is wrong. Pain is important; without it abnormal conditions may go undetected,
causing damage or injury to vital parts of our bodies.
Even though pain is a necessary warning signal of trauma or malfunction in the
body, nature may have gone too far in its design. Aside from its value in
diagnosis, longlasting persistent pain serves no useful purpose. Pain does not
begin until coded message travels to the brain where it is decoded, analysed,
and then reacted to. The pain message travels from the injured area along the
small nerves leading to the spinal cord. Here the message is switched to
different nerves that travel up the spinal cord to the brain. The pain message
is then interpreted, referred back and the pain is felt.
EXPLANATION OF TENS
Transcutaneous Electrical Nerve Stimulation is a non-invasive, drug-free
method of controlling pain. TENS uses tiny electrical impulses sent through
the skin to nerves to modify your pain perception. TENS does not cure any
physiological problem; it only helps control the pain. TENS does not work for
everyone; however, in most patients it is effective in reducing or eliminating
the pain, allowing for a return to normal activity.
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11
INTRODUCTION TO TENS
How to use your TENS?
It is useful for you to have a pain assessment before you start TENS. This
will identify what kind of pain you have and exactly where it is. If you have
numb areas on your skin, for example, these will need to be avoided as TENS
needs an intact nerve pathway to work. Two-channel (four-electrode) machines
are more flexible especially if the pain is large or widespread. Start with
conventional TENS with continuous pulse settings. · Use middle pulse
frequency(approx 80-100 per second) and pulse duration (100-
200 microseconds). · Increase the intensity until the sensation is strong and
a little uncomfortable, then
turn it down slightly, until comfortable. · You may need to experiment with
the settings as there is no sure way of telling which
combination will suit you without trial and error. · Put the electrodes on
normal healthy skin. Check to make sure you don’t have any
cuts or other breaks in the skin which could be very uncomfortable and react
badly. · Take time to find the best electrodes placements – this may be
tricky.
During the TENS treatment
If your muscles start to twitch. This may mean that the TENS signals are too
strong or too fast. If you cannot feel any tingling at all. This may mean that
the signal is too weak or too slow. The electrodes should be removed at least
once a day if the TENS treatment is used around the clock. The skin under the
electrodes must be checked to see if it is red or tender. The skin should also
be cleaned and dried while the electrodes are off. Put lotion on your skin
where the electrodes were placed. The electrodes should be put in a new place
for each new treatment. This will help prevent the skin from becoming red or
sore.
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Telephone: 0161 429 7330
12
WHICH PROGRAMME SHOULD I USE?
We always recommend you start with programme 1, as already mentioned in your
stepby-step guide. The premier TENS has 12 programmes P1 to P12, Each
programme has been shown to reduce and block pain in a wide range of
conditions. It is very difficult to know which programme is best for you. It
is therefore recommended that over a period of time you try all 12 programmes.
To help get you started, we have included some common conditions with
suggested electrode placements including treatment times and recommended
programmes you may wish to try.
HOW HIGH SHOULD I TURN THE INTENSITY?
Everybody reacts differently to TENS Stimulation so it is important that you
increase the intensity (sensation feeling) to the correct level.
Increase the intensity to a sensation which is comfortable and always
perceptible; never turn up to a level which is strong and uncomfortable.
You may use TENS if required for long periods of time to combat long term
chronic pain, however, please remember to place the electrodes in slightly
different areas around the painful site, as this will help reduce skin
irritation.
HOW LONG SHOULD A TYPICAL TREATMENT TIME LAST
The most up to date research in TENS treatment times, indicates that a minimum
of 1 hour to 11/2 hours is required for effective pain relief. Your TENS may
be used for much longer periods and you may find treatment times of 3 to 4
hours may work best for you.
Please remember that the intensity level is always kept at a pleasant
sensation, never increase the intensity to uncomfortable levels as this can
possibly have a detrimental effect on your results.
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13
MED-FIT PREMIER TENS PROGRAMMES
P1-P12 – 12 Clinically validated TENS programmes for drug-free pain relief.
(All programmes run on a continuous time indicated by the letter [C] on your
display.
Programme 1 Conventional TENS
Ideal for your first TENS treatment, for both acute, chronic and long-term
use. Suitable Conditions Neck Pain – Shoulder Pain – Knee Pain – Lower Back
Pain – Sciatica – Arthritic Pain
Programme 2 Sciatica – Pain Relief
Effective pain relief for irradiation of pain along the path of the sciatic
nerve, for electrode placement please refer to page 23. Recommended treatment
time 2 + hours or until pain alleviates.
Programme 3 Lower back Pain
Programme 3 is most effective for lower back pain and increased blood
circulation. This programme alleviates the pain by stimulating muscles to
release the body’s own morphine-like substances for electrode placement please
refer to page 23. Recommended treatment time 90 minutes or until the pain
subsides.
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Telephone: 0161 429 7330
14
MED-FIT PREMIER TENS PROGRAMMES
Programme 4
Knee Pain
This programme is ideal for treating knee injuries both acute and chronic
including osteoarthritis rheumatoid arthritis and joint pain. for examples of
electrode placement please refer to pages 23 and 24.
Programme 5 Shoulder Pain
Treating shoulder pain relief from heavy or repetitive lifting, arthritis, and
tendinopathy. Please refer to page 22 for electrode placement.
Programme 6 Muscle Pain
This programme is pre-set for all types of muscle pain relief ideal for muscle
tension in the neck, shoulder and lower back (lumbar spasms). Please refer to
pages 22 to 25 for electrode placement.
Programme 7
Migraine/Headaches
Reduced pulse width ideal for treating nerve rich areas.
Suitable Conditions Tension Type Headache, Facial Pain, Neck Pain,
Postherpetic Neuralgia.
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15
MED-FIT PREMIER TENS PROGRAMMES
Programme 8 Cervical (Neck) Pain
Cervical pain relief due to poor ergonomic work positions. Please see the
electrode placement page 21 for more details.
Programme 9
Epicondylitis – (Elbow)
Pain relief for epicondylitis resulting from repetitive gripping and objects.
Please see the electrode placement page 20 for more details.
Programme 10
Foot & Ankle Pain
This programme is most suited for foot and ankle pain and increases
circulation. Please see the electrode placement page 21 for more details.
Programme 11
Arthritic Pain
This programme is ideal for arthritic pain as it can be used for long periods
of time with little or no accommodation which offers superior pain relief on
most areas of the body.
Programme 12
Joint Pain & Fracture Pain
This programme is ideal for all common areas of joint pain, with this treatment we recommend that the stimulation is increased to a stronger level than the pain itself.
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16
ADJUSTING THE CONTROLS USING
THE MANUAL ADJUSTMENT
1. Power On/Off/Pause Button
The power of unit can be turned on by pressing the On/Off/Pause button. You
may start to adjust the settings when the liquid crystal display is on. Press
and hold for 2 seconds to switch off. To pause stimulation press the button
once. To resume stimulation press the button again and stimulation will be
restored in 2 seconds.
00
B 60 B 60 TENS
TENS
Min
Min
If the unit is not used (buttons not pressed or output level at 0) for 5 minutes, the power will be shut off automatically.
2. Mode Control MODE
There are 5 TENS modes (B, N, M, S1, S2) available. The mode is selected by
pressing the “Mode” button.
0
TENS
B
0 60 Min
B = Burst Mode N = Normal or constant mode M = Modulation Mode S1 = Modulation Mode Advanced S2 = Modulation Mode Advanced
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17
<
<
ADJUSTING THE CONTROLS USING
THE MANUAL ADJUSTMENT
3. Set Control SET By pressing the “Set” control you select the setting you
intend to adjust. The value is set by pressing the “Increment” or “Decrement”
controls when the “Set” value is flashing. 4. Increment Control This button
controls the increase of settings.
5. Decrement Control This button controls the decrease of settings.
6. Intensity Increase Control There are 99 steps of intensity adjustment
control. Press the button until the desired intensity level is reached.
7. Intensity Decrease Control There are 99 steps of intensity adjustment
control. Press the button until the desired intensity level is reached.
8. Key Lock Facility Pressing the “Lock” buttons prevents the settings being
changed but the output may be stopped by pressing the “On/Off/Pause”.
Key Lock
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18
ADJUSTING THE CONTROLS USING
THE MANUAL ADJUSTMENT
9. Steps to Set a TENS Program The settings can be adjusted according to the following steps.
a. Turn on the Power b. Select a Mode
Select a mode by pressing the “Mode” control. The mode you selected will show
up on the top of liquid crystal display. There are 5 modes of your option
including B(Burst), M(Normal), M(Modulation), S1, S2 and P. When a TENS mode
is selected, it shows “TENS” on the liquid crystal display.
00
B 300 TENS
Width
After a mode is selected, always press “Set” to enter
next setting, and press ”
” or
”
<
” to adjust its value.
< <
c. Set Pulse Width
Pulse Width is adjustable from 50 µs to 300 µs. Press “SET” control to enter this
menu, then press ”
” or ”
<
” to adjust the setting. If no instructions
regarding the pulse width are given in therapy, set the control to the suggested 70-
120 µs setting.
00
B 300 TENS
Width
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19
< <
< <
ADJUSTING THE CONTROLS USING
THE MANUAL ADJUSTMENT
d. Set Pulse Rate
Pulse rate is adjustable from 2Hz to 150 Hz . Press “SET” control to enter this menu,
then press ”
” or ”
” to adjust the setting. Unless otherwise
instructed, set the pulse rate l to the 70-120 Hz range.
00
B 50 TENS
Rate
e. Set Timer
The treatment time is adjustable between 5 – 60 minutes and Continue(C). Press
“SET” control to enter this menu, then press ”
” or ”
” to adjust the
setting. The liquid crystal will show the balance treatment time after the stimulation
is started. Output will be terminated when time is up. Turn off the unit when the
output is off.
0 00 00 0
B 60 B TENS
TENS
Min
TENS
B C
0 Min
f. Adjust Intensity There are 99 steps within the intensity range. Set the
desired level by pressing the ” “or” “controls. Press the
“Lock” button to prevent accidental changes.
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80 80
B 60 TENS Min
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20
HELPFUL TIPS FOR SUCCESSFUL TENS TREATMENT
Once you have familiarised yourself with the controls and features of your
TENS device, it is important to place the TENS electrodes in a position which
gives the most pain relief. This may take 3 or 4 attempts to find the most
suitable position, for maximum pain relief. If you are using two electrodes,
place the electrodes directly onto the painful area at a position where you
feel the pain starts and where it finishes. You may now position the
electrodes around the painful area to locate the most suitable position for
maximum pain relief. The alternative method is to use four electrodes
surrounding the painful area see examples. The complete area between the
electrodes will now be treated when positioning the electrodes as shown.
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21
EXAMPLES OF ELECTRODE PLACEMENT
Here are three examples of electrode placement for knee pain. For best
results, we recommend you try all variations as shown.
TENS using one channel vertical pad placement
TENS using one channel horizontal pad placement
TENS using both channels www.tensmachineuk.com
Red squares represents placement of electrode Channel 1
Blue squares represents Placement of electrode Channel 2
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22
TENS ELECTRODE PLACEMENT
Frozen Shoulder
Shoulder Pain
Suggested Programmes P1, P5, P12
Suggested Programmes P1, P5, P12
Primary Placement
Primary Placement
Degenerative Arthritis: Cervical and Lumbar
Suggested Programmes
P1, P3, P8, P11
Alternative Placement
Chronic Hip Pain
Suggested Programmes P1, P11, P12
Primary Placement
Alternative Placement Telephone: 0161 429 7330
Primary Placement www.tensmachineuk.com
23
TENS ELECTRODE PLACEMENT
Lower Back Pain
Hip Neuralgia
Suggested Programmes P1, P3
Suggested Programmes P12,P11
Primary Placement
Primary Placement
Phantom Limb, Lower Extremity Sciatica
Suggested Programmes P12
Suggested Programmes P1, P2, P3
Primary Placement
Primary Placement www.tensmachineuk.com
Alternative Placement Telephone: 0161 429 7330
24
TENS ELECTRODE PLACEMENT
Low Extremity Pain
Wrist Pain
Suggested Programmes P6, P12
Suggested Programmes P1, P12
Primary Placement
Primary Placement
Alternative Placement
Primary Placement Alternative Placement
Carpal Tunnel Syndrome
Suggested Programmes P6
Degenerative Arthritis Knee Pain
Suggested Programmes
P4, P12
Primary Placement
Alternative Placement
Elbow & Forearm Pain
Suggested Programmes P9, P6
Primary Placement
Telephone: 0161 429 7330
Primary Placement www.tensmachineuk.com
25
TENS ELECTRODE PLACEMENT
Lower Leg Pain
Knee Pain – Post-Op
Suggested Programmes P4, P6, P12
Suggested Programmes P4, P6, P12
Primary Placement
Primary Placement
Alternative Placement
Cervical Placement
Alternative Placement
Chronic Cervical Strain
Suggested Programmes P8
Suggested Programmes P8
Primary Placement
Primary Placement
Alternative Placement www.tensmachineuk.com
Alternative Placement Telephone: 0161 429 7330
26
LIMITED WARRANTY
Med-Fit UK Ltd warrants to the initial Purchaser (“Purchaser”) (and to no
other person) that the product with the exclusion of accessories such as
chargers, rechargeable batteries, electrodes, lead wires, self-adhesive
electrodes and the component parts thereof, distributed or manufactured for
one year from the initial date of purchase from Med-Fit UK Ltd (“the Warranty
Period”).
Accessories including, but not limited to chargers, rechargeable batteries,
electrodes, lead wires and adhesive electrodes are excluded from the warranty
and sold “AS IS’ because their structure is such that they may be easily
damaged before or during use.
Limited of Liabilities and Disclaimer of Warranties
Med-Fit UK Ltd sole obligation in the case of any breach of its warranties set
forth in the paragraph above, shall be, at Med-Fit UK Ltd option, to repair or
replace the Product without charge to Purchaser or to refund the purchase
price of the Product. In order to recover under this Warranty, Purchaser must
send Med-Fit UK Ltd written notice of the defect (setting forth the problem in
reasonable detail) prior to expiration of the Warranty Period, and within 30
days of discovery of the defect.
Skin Patch Test
It is recommended that you carry out a patch test before applying your first
treatment, To do this, remove one electrode from the packaging and place on a
part of your body which is both visible and easy to inspect.
After 30 minutes, remove the electrode and inspect the area for any redness or
irritations. If no change is noticed, proceed with your first TENS treatment
following the User Guide and Instructions provided. If skin irritation has
been noticed, we recommended the use of sensitive gel electrodes.
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ELECTRODE INSTRUCTIONS
Turn Stimulator OFF before applying or removing electrodes
Application 1. Skin site must be very clean and dry. Dirty, flaky or oily skin
will prevent electrodes from
adhering to the skin. If necessary, trim excess hair with scissors. If skin is
oily wipe down with an alcohol or electrode skin prep prior to application. Be
sure to wash hands before handling electrodes. 2. Remove electrodes from bag
and reseal bag to protect remaining electrodes. 3. Grasping a tiny edge of the
electrode, peel and remove electrode from the protective plastic liner. Save
liner for electrode storage. 4. Place electrode onto skin treatment site (as
recommended by your clinician) by firmly applying from the centre of the
electrode to the outer edges. Adhesion improves when electrodes reach skin
temperature. 5. If gel appears oversaturated with excessive moisture or
perspiration, allow the electrode to air-dry in a refrigerator with the gel
side facing up until the gel regains its tack. If the gel appears dry, try
adding a few drops of water to the gel and allow to rest in a dust-free
environment until the gel regains its tack.
Removal and storage 1. Lift a corner of the electrode and slowly peel the
electrode off the skin, touching the
adhesive gel as little as possible. 2. Place the electrodes back onto the
saved protective plastic liner. 3. While grasping the electrodes connector
with one hand, use the other hand to gently twist
and disconnect the lead wire pin from the electrode connector. . 4. Return the
electrodes back into the storage bag and reseal tightly to prevent dry-out. 5.
Store at room or cool temperature and keep out of direct sunlight. 6. The life
of the electrode varies depending on skin conditions, amount of use, storage
and
climate. Electrode life may be extended by carefully following the
application, removal, and storage instructions.
Caution 1. DO NOT place electrodes on broken skin. If skin irritation develops
discontinue use. Consult
physician. Replace electrodes when they do not adhere or when treatment
becomes uncomfortable. 2. DO NOT use unit while driving or operating machinery
3. DO NOT wear electrodes when showering, bathing or swimming 4. DO NOT apply
electrodes across the head or across the heart or on the front of your neck.
5. Keep electrodes separated during treatment 6. Using stimulation electrodes
that are small or incorrectly applied could result in discomfort or skin
burns.
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28
SAFETY-TECHNICAL CONTROLS
For safety reasons, review the following checklist before using your EM6100A
Digital TENS. 1. Check the device for external damage.
– deformation of the housing. – damaged or defective output sockets. 3. Check
the usability of accessories. – patient cable undamaged – electrodes
undamaged. Please consult your distributor if there are any problems with
device and accessories.
MALFUNCTIONS
Should any malfunctions occur while using the EM6100A Digital TENS/EMS, check
– check the cable is correctly connected to the device. The cables should be
inserted
completely into the sockets.
CONFORMITY TO SAFETY STANDARDS
The EM6100A Digital TENS devices are in compliance with the following
standards: EN 60601-1-2: 2007 Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance -Collateral standard:
Electromagnetic compatibility -Requirements and tests EN 60601-1:2006 Medical
electrical equipment Part 1: General requirements for basic safety and
essential performance
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29
GRAPHIC SYMBOLS
Degree of Electrical Protection BF Timer Increment Decrement Consult
instructions for use Manufacturer Serial number Lock Low battery Pause DC
current (DC Power source) Comply with MDD 93/42/EEC requirement as amended by
2007/47/EC. Notify body det norske veritas (DNV) Power
The label attached to the back of device contains important information about
this device model, supply voltage, CE number and caution. Please don not
remove.
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30
The Premier Plus TENS Programmes P1-P12
NO PROGRAMME
FREQUENCY PULSE WIDTH
1 Conventional TENS – Ideal for first applications of TENS for both acute and long term pain
80Hz
CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Hip Pain, Osteoarthritic Pain in the knee
180µs
2 Burst TENS – Most effective for radiating pain if arms
2Hz
and legs and deep muscular pain
CONDITIONS Osteoarthritic Pain in the Knee, Sciatica Central Pain
180µs
3 Modulated TENS – Pain relief with a massage effect CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Menstrual Pain, Hip Pain, Osteoarthritic Pain in the knee
80Hz
70-180µs
4 Mixed Frequency TENS
15Hz/2Hz
CONDITIONS Osteoarthritic Pain in the knee, Neck Pain, Shoulder Pain, Menstrual Pain, Central Pain Lumbago
180µs
5 Fixed Frequency TENS – Effective programmes for long term use with reduced accommodation factor
80Hz/2Hz
CONDITIONS Osteoarthritic Pain in the knee, Neck Pain, Shoulder Pain Menstrual Pain, Central Pain Lumbago
180µs
6 Conventional TENS – Ideal for muscle pain for both acute and long term pain
10Hz
CONDITION S Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Hip Pain, Osteoarthritic Pain in the knee
180µs
7 Migraine/Headaches – Reduced pulse width ideal for treating nerve rich areas
80Hz
CONDITIONS Tension Type Headache, Facial Pain, Neck Pain, Postherpetic Neuralgia
60µs
8 70% Rate Modulation over 10 seconds
10Hz
200µs
CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Menstrual Pain, hip Pain,
Osteoarthritic Pain in the Knee
9 90% Rate Modulation over 10 seconds
50Hz
250µs
CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Menstrual Pain, hip Pain,
Osteoarthritic Pain in the Knee
10 Mixed Frequency long term use programme. Ideal for treating chronic pain over long periods example 5+ hours
5-125Hz
120µs
CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Menstrual Pain, hip Pain, Osteoarthritic Pain in the Knee
11 Modulation Rate & width over 6 seconds
2-100Hz
260-150µs
CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Menstrual Pain, hip Pain,
Osteoarthritic Pain in the Knee
12 Modulation Rate over 6 seconds
80<->7Hz
260µs
CONDITIONS Neck, Shoulder, Elbow Pain, Rheumatic Pain, Lumbago, Menstrual Pain, hip Pain, Osteoarthritic Pain in the Knee
Telephone: 0161 429 7330
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31
TECHNICAL SPECIFICATIONS
The technical specification details of EM6100A are as follows:
MECHANISM 01 Channel 02 Pulse Amplitude 03 Wave Form 04 Voltage 05 Power
source 06 Size 07 Weight 08 Timer
09 Low Battery Indicator 10 Operating Condition
11 Remark
TECHNICAL DESCRIPTION
Dual, isolated between channels Adjustable, 0-100 mA peak into 500 ohm load
each channel. Asymmetrical Bi-Phasic Square Pulse 0 to 50V (Load: 500 ohm)
Lithium Battery 11.8cm(L) x 6cm(W) x 3.1cm(H) 150 grams with battery.
Adjustable, from 1 to 60 minutes or Continuous. Adjustable in 1 minute each
step from 1 to 15 minutes, and 5 minutes each step from 15 to 60 minutes.
Treatment time countdown automatically. A low battery indicator will show up
when the battery is low. Temperature: °~°C Relative Humidity: 30%~75%
Atmosphere Pressure: 700Hpa~1013Hpa There may be up to a +/-5% tolerance of
all parameters and +/-20% tolerance of output amplitude & voltage.
The waveforms of the TENS modes are as follows.
Burst
Modulation
Normal www.tensmachineuk.com
S1 (Strength-Duration) S2 (Strength-Duration)
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32
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
This product needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided, and this unit
can be affected by portable and mobile RF communications equipment. 1) Do not
use a mobile phone or other devices that emit electromagnetic fields, near the
unit. This may result in incorrect operation of the unit. 2) Caution: This
unit has been thoroughly tested and inspected to assure proper
performance and operation! 3) Caution: this machine should not be used
adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, this machine should be
observed to verify normal operation in the configuration in which it will be
used 4) Warning: The use of ACCESSORIES, transducers and cables other than
those specified, with the exception of transducers and cables sold by the
MANUFACTURER of the DEVICE as replacement parts for internal components, may
result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME
SYSTEM.
Guidance and manufacture’s declaration electromagnetic emission
The DEVICE is intended for use in the electromagnetic environment specified below. The customer of the user of the DEVICE should assure that it is used in such an environment.
Emission test
Compliance Electromagnetic environment guidance
RF emissions CISPR 11
Group 1
The DEVICE use RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11
Class B
The DEVICE is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions Class A IEC 61000-3-2
Voltage fluctuations Complies /flicker emissions IEC 61000-3-3
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Guidance and manufacture’s declaration electromagnetic immunity
The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of DEVICE should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast ±2 kV for power ±2kV for power
transient/burst supply lines
supply lines
IEC 61000-4-4
Mains power quality should be that of a typical commercial or hospital environment.
Surge
± 1 kV line(s) to ±1 kV differential Mains power quality should be
IEC 61000-4-5 line(s)
mode
that of a typical commercial
or hospital environment.
Voltage dips, short interruptions
<5% UT
<5% UT
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycle
for 0.5 cycle
and voltage
variations on 40% UT
40% UT
power supply (60% dip in UT) (60% dip in UT)
input lines
for 5 cycles
for 5 cycles
IEC 61000-4-11
70% UT
70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
for 5 sec
for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the DEVICE requires continued operation during power mains interruptions, it is recommended that the DEVICE be powered from an uninterruptable power supply or a battery.
<5% UT
<5% UT
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycle
for 0.5 cycle
for 5 sec
for 5 sec
Power frequency (50Hz/60Hz) magnetic field 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital IEC environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Telephone: 0161 429 7330
34
Guidance and manufacture’s declaration electromagnetic immunity
The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of DEVICE should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance test level level
Electromagnetic environment – guidance
Conducted RF 3 Vrms 3 Vrms
IEC
150 kHz to
61000-4-6 80 MHz
Radiated RF IEC 61000-4-3
3 V/m
3 V/m
80 MHz to
2.5 GHz
Portable and mobile RF communications equipment should be used no closer to
any part of the DEVICE, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter. Recommended separation distance
80 MHz to 800 MHz 800 MHz to 2.5 GHz Where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in metres (m).Field
strengths from fixed RF transmitters, as determined by an electromagnetic site
survey,should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DEVICE is used exceeds the applicable RF compliance level above, the DEVICE should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the DEVICE. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Telephone: 0161 429 7330
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35
Recommended separation distances between portable and mobile RF communications equipment and the DEVICE .
The DEVICE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DEVICE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DEVICE as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
Separation distance according to frequency of transmitter
output power of
(m)
transmitter
(W)
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01
0.117
0.1
0.369
1
1.167
10
3.689
100
11.667
0.117 0.369 1.167 3.689 11.667
0.233 0.738 2.333 7.379 23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
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Telephone: 0161 429 7330
Tel:0161 429 7330 Fax:0161 427 0215
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References
- The UK domain name fit.co.uk is for sale!
- Med-Fit | Tens Machines | Muscle Stimulators & Maternity Tens