TensCare Flexistim Instructions For Use Manual
Instructions For Use
Flexistim
READ INSTRUCTIONS CAREFULLY BEFORE USE
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FOREWORD
Read this User Manual carefully before you start using your Flexistim unit.
The manufacturer strongly recommends carefully reading of the “Warnings and Cautions” and
Chapters of this User Manual.
1 INTRODUCTION 1
2 WARNINGS AND CAUTIONS 2
3 HOW TENS WORKS 5
4 EMS: WHAT IT IS AND HOW IT WORKS 6
4.1 Mode of operation 7
4.2 Treatment time and treatment interval 7
4.3 Choosing the right strength 8
5 TENS and EMS STIMULATION PARAMETERS: 8
5.1 Pulse Waveform 8
5.2 Pulse Frequency 9
5.3 Pulse Width 9
5.4 Pulse Intensity 10
5.5 WORK 10
5.6 REST 10
5.7 RAMP 10
6 IFT: WHAT IT IS AND HOW IT WORKS 11
7 MICROCURRENT 12
8 KEYPAD AND DISPLAY 13
9 CONTENTS OF THE PACK 18
10 HOW TO ASSEMBLE YOUR UNIT 19
11 OPERATION 22
11.1 Turn on the Device 22
11.2 Select Mode 22
11.3 Select a Programme 22
11.4 Set Treatment Timer 23
11.5 Attach the Electrode Pads 23
11.6 Adjust the Intensity 24
11.7 Skip Function 24
12 ADJUSTING MANUAL PROGRAMMES 25
12.1 TENS 25
12.2 EMS 26
12.3 IFT 27
12.4 MICROCURRENT 27
13 LOCK AND UNLOCK YOUR OWN PROGRAMME 28
14 MEMORY MODE 28
15 PROGRAMMES 29
15.1 TENS PROGRAMMES 29
15.2 EMS PROGRAMMES 31
15.3 IFT PROGRAMMES 34
15.3.1 CHOOSING SETTINGS 34
15.4 MICROCURRENT PROGRAMMES 35
15.4.1 CHOOSING SETTINGS 35
15.4.2 HOW LONG SHOULD EACH SESSION LAST? 36
15.4.3 FOLLOW-UP 36
15.4.4 PROBLEMS 36
16 ELECTRODE PAD PLACEMENT 37
16.1 Electrode Pad Placement for TENS 37
16.2 Electrode Pad Placement for EMS 39
16.3 Electrode Pad Placement for IFT 44
16.4 Electrode Pad Placement for Microcurrent 46
17 FURTHER CLINICAL INFORMATION AND TREATMENT PROTOCOLS 47
18 CARE OF ELECTRODES 47
19 CHARGING THE BATTERY 48
20 TROUBLESHOOTING 50
21 CLEANING 51
22 CONSUMABLES AND SERVICING 51
23 WARRANTY 52
24 DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE) 52
25 SPECIFICATIONS 53
26 STANDARD SYMBOLS 55
27 EMC PRECAUTIONS 55
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1. INTRODUCTION
INTENDED USE
The Flexistim combines the treatment capabilities of a TENS device, an EMS or NMES
device, a MIC stimulator, and an IFT stimulator all in one unit.
TENS stands for Transcutaneous Electrical Nerve Stimulation. The TENS settings are
used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Muscular Stimulation. The EMS settings are used to provide a
muscular training for localised regeneration and muscular hypertrophy.
MIC stands for MicroCurrent Stimulation. The MIC settings are used to provide
symptomatic pain relief for chronic, acute or post-operative pain, and the DC setting is
used for wound healing.
IFT stands for Interferential Stimulation. The IFT settings are indicated for symptomatic
relief of chronic intractable pain.
The Flexistim is intended for use in both the Hospital and Home Healthcare Environments.
FLEXISTIM FEATURES
Flexistim includes many of the features of a professional desk-top unit in a compact,
portable, battery operated device.
1. Multiple Functions
10 TENS programmes, 27 EMS programmes, 4 IFT Programmes, 4 Microcurrent
Programmes and 6 user dened programmes enabling you to experiment and save your
favourite settings - unrivalled performance for a product of this size and price.
2. Output
99mA TENS and EMS
60mA Peak to Peak pure sinusoidal carrier wave with constant energy (modied constant
current) control and 40mA safety override for home use.
700μA Microcurrent with DC option.
3. Memory
Flexistim allows you to save and recall a particular programme setting and has a Usage
Timer to record the time it has been used.
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4. Power Supply
Removeable, rechargeable Li-ion battery, with option of operation through external mains
power adaptor.
2. WARNING AND CAUTIONS
Contraindications:
1. Do not use this device on patients who have a cardiac pacemaker, implanted
debrillator, or other implanted electronic devices, because this may cause electric
shock, burns, electrical interference, or death.
2. Do not use this device on patients whose pain syndromes are undiagnosed.
Warnings:
1. Do not apply stimulation over the neck or mouth because this could cause severe
muscle spasms resulting in closure of the airway, difculty in breathing, or adverse
effects on heart rhythm or blood pressure.
2. Do not apply stimulation across the chest, because IFT currents penetrate deep into
the tissue and the introduction of electrical current into the chest may cause rhythm
disturbances to the patient’s heart, which could be lethal.
3. Do not apply stimulation over the pregnant uterus.
4. Do not apply stimulation, other than microcurrent, over open wounds or rashes,
or over swollen, red, infected, or inamed areas or skin eruptions (e.g. phlebitis,
thrombophlebitis, varicose veins).
5. Do not apply stimulation over, or in proximity to, cancerous lesions.
6. Do not apply stimulation in the presence of electronic monitoring equipment (e.g.
cardiac monitors, ECG alarms), which may not operate properly when the electrical
stimulation device is in use.
7. Do not apply stimulation when in the bath or shower.
8. Do not apply stimulation while driving, operating machinery, or during any activity in
which electrical stimulation can put the patient at risk of injury.
9. Consult with your physician before using this device, because the device may cause
lethal rhythm disturbances to the heart in susceptible individuals.
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General Warnings:
1. Do not immerse any part of the unit in water
2. Do not place the unit close to excessive heat.
3. Do not use any electrodes which are less than 50mm X 50mm.
4. Use only the specied battery: 1x 3.7volt rechargeable lithium battery. The use of any
other battery could damage the unit.
5. Remove battery if unit is not used for a long period of time.
6. Do not use the unit while asleep.
7. Do not put the lead wire on, or wrapped around the neck.
8. Use this device only with the leads, electrodes and accessories recommended by the
manufacturer. Use of other parts materials supplied by the manufacturer can degrade
minimum safety and invalidate the warranty.
9. After inserting plugs into both CH1 and CH2 sockets, please do not remove the
plugs when the unit is working. Ensure that the unit is switched OFF before removing
the plugs.
10. Keep the unit away from sources of high magnetic elds such as TV’S, microwave
ovens and hi- speakers, as these may affect the LCD screen.
11. Keep the device away from a replace or radiant heater, as the heat may affect
the device.
12. Keep the device away from nebulizer or steam kettle, as the moisture may affect
the device.
13. Keep the device away from sunlight, as long-term exposure to sunlight may affect the
rubber causing it to become less elastic and crack.
14. Keep the device away from lint and dust, as long-term exposure to lint or dust may
affect the sockets or cause the battery connector to develop a bad contact.
15. Temperature & Relative Humidity of storage: -20°C–+40°C, 8%--70% R.H.
16. Temperature & Relative Humidity of transportation: -20°C–+40°C, 8%--70% R.H.
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10. Apply stimulation only to normal, intact, clean, healthy skin.
11. Using the device directly over metallic implants could cause the currents to focus
over a small area, causing tissue burns. If you have metal implants, do not place the
pads near, or across the implant, and adjust the intensity with care.
Precautions:
1. Since 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, unless you are in Microcurrent mode.
2. The safety of electrical stimulation during pregnancy has not been established.
3. Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel).
4. Patients with suspected or diagnosed heart disease should follow precautions
recommended by their physicians.
5. Patients with suspected or diagnosed epilepsy should follow precautions recommended
by their physicians.
6. Use caution when the patient has a tendency to bleed internally, such as following an
injury or fracture.
7. Use caution following recent surgical procedures when stimulation may disrupt the
patient’s healing process.
8. Use caution if stimulation is applied over areas of skin with less than normal sensitivity.
9. Keep this device out of the reach of children.
Adverse Reactions:
• Patients may experience skin irritation and burns beneath the stimulation electrodes
applied to the skin.
• Patients may experience headache and other painful sensations during or following the
application of electrical stimulation near the eyes and to the head and face.
• Patients should stop using the device and should consult with their physicians if they
experience adverse reactions from the device.
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3. HOW TENS WORKS
TENS stands for Transcutaneous Electrical Nerve Stimulation. TENS stimulates your
body’s own natural defences against pain. It is totally safe and has been used successfully
by thousands of pain sufferers.
TENS sends a gentle stimulation through the skin which works in TWO ways:
Pain Gate
Stimulating the sensory nerves, which carry touch and temperature signals. These
nerves go to the same connections in the spine as the nerves carrying pain. A strong
sensory signal will block the pain signal travelling up the spine to the brain. This is known
as closing the “Pain Gate” and takes effect quite quickly after the unit is switched on. You
can use TENS several times a day, for as long as you like.
Endorphin Release
At low frequency settings, and slightly stronger output, TENS drives the motor nerves
to produce a small repetitive muscle contraction. This is seen by the brain as exercise
and this promotes release of Endorphins – your body’s own natural pain killer. The relief
builds up and normally takes about 40 minutes to reach a maximum level which can last
for hours after the machine is switched off.
By using TENS you can expect to achieve a signicant reduction in pain if not complete
pain relief.
Side Effects
There are no known side effects to TENS use and long-term TENS use is not harmful.
Positioning the electrodes for TENS
The TENS effect is conned to the nerves entering a single vertebra in the spine. To be
effective, you therefore need to stimulate a sensory nerve entering the spine at the same
level as the nerve carrying the pain. For this reason electrodes are usually rst placed
where the greatest pain is felt. Nerves follow the curve of the ribs and spiral around the
limbs, so you will need to try different positions until you nd the best for you. Try moving
the electrodes short distances to establish the positions that are most effective for you.
TENS is clinically tested and approved for many applications including:
• Back pain and lumbar and cervical spine problems
• Joint pain (e.g. knee joint, hip joint, shoulder)
• Neuralgia • Headaches • Women’s period pains
• Pain after injuries to musculoskeletal system
• Pain with circulatory problems
• Chronic pain through various causes
4. EMS: WHAT IT IS AND HOW IT WORKS
EMS stands for Electrical Muscle Stimulation and is a widespread and generally
recognised method which has been used for years in sports and rehabilitation medicine.
In the sports and tness eld, one of the uses of EMS is as a supplement to conventional
muscle training, in order to increase the efciency of muscle groups and adapt physical
proportions to the desired aesthetic results.
EMS has two main applications. Firstly, a targeted strengthening of musculature can
be produced (Activating application) and secondly a relaxing, resting effect can also be
achieved (Relaxing application).
EMS successfully rebuilds and tones muscles.
Different levels of muscle contraction are achieved by sending electrical impulses of
various types, depending on the programme selected, into the body. These muscle
contractions retrain the muscles, increase their effectiveness and improve their condition.
This is benecial where muscles - for whatever reason - have not been in regular use and
have lost condition (muscle atrophy). For sports, the benet is to increase the effect of
training and enhance performance.
Typical uses are:
• Muscle training to improve endurance performance
• Muscle training to support the strengthening of certain muscles or muscle groups in
order to achieve desired changes to body proportions
• Sports training, covering - warm-up, strength, speed, power, resistance, endurance
and recovery
• Rehabilitation in relation to sports injury
The effect on muscle tone of electrical stimulation (EMS) is generally only noticeable after
regularly repeated application. Electrical stimulation does not replace regular exercising
of the muscle, but is able to reasonably supplement it.
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MONOPHASE PULSES
PULSE
INTENSITY
BIPHASIC PULSES
BIPHASIC PULSES
7 8
Muscle wastage: EMS is used in the treatment of medical conditions involving muscle
wastage including: Neuromuscular facilitation - Muscle re-education - Muscle training Prevention/slowing of atrophy/hypotrophy - Preventing postoperative muscle weakness
- Reduction of spasticity - Maintaining or increasing range of motion - Training of partial
peripheral nerve damage with signs of re-innervation - Treatment of scoliosis.
4.1 Mode of operation
EMS uses external electrical impulses that act through the skin to stimulate the nerves
supplying a specic muscle group.
The muscle reacts in different ways depending on the strength of current and duration
and frequency of the electrical impulse.
Muscles are made up of two different types of bre:
- Red bre is slower contracting and aerobic working.
- White bre is faster acting and capable of anaerobic working.
The proportions of red and white bres depend on the way the muscle is used.
Fibre can be converted from one type to the other, depending on the signals it receives.
This is known as the Trophic effect.
Different frequencies have different effects: Low (1-10 Hz) frequencies coupled with
long impulse times have a purifying and relaxing effect through individual contractions,
whereby the circulation in the treated muscle is simultaneously improved and removal
of metabolic end products is supported (lymphatic drainage). The oxygen supply to the
muscle is improved.
In contrast, medium (20-50 Hz) frequencies can put a high level of strain on the muscle,
thus promoting the muscular structure.
Very high frequencies (60-90 Hz) can be used to promote muscle denition and bulk.
The body maps at the back of this guide show pad positioning in order to stimulate
specic muscle groups.
4.2 Treatment time and treatment interval
Treatment by EMS can vary between 15–60 minutes stimulation twice a week to treatment
several times per day.
4.3 Choosing the right strength
The object of EMS treatment is to produce powerful muscle contractions.
The strength of the current should be increased to about three times the level at which
you can rst feel the tingling, or to as high as you can stand without causing pain. You
will probably feel that electrical contraction is being more powerful than a voluntary
contraction, because the current also stimulates your sensory nerves. The signals have
a pain-relieving effect.
You may nd the sensation uncomfortable to start with, therefore you may not get up
to therapeutic strength at the start of treatment. The strength can be increased during
the course of the treatment, as you become accustomed to the sensation. Voluntary
muscular activity is more effective than stimulation, and it may improve progress if you
combine voluntary contraction with stimulation.
The powerful muscle contractions caused by electrical stimulation give rise to training
aches, which usually disappear within a week.
After treatment tingling sensations may continue or your skin may feel numb, this
is normal.
5. TENS and EMS STIMULATION PARAMETERS:
The effect of electrical stimulation on the body depends on the following current settings:
5.1 Pulse Waveform
This describes the time function of the excitation current which may be either monophasic
or biphasic.
With monophasic pulse trains, the current ows in one direction. With biphasic pulses,
the excitation current alternates its direction.
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PULSE WIDE
BIPHASIC PULSES
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10
Frequency indicates the number of individual
pulses per second, and is indicated in
Hz (Hertz = pulses per second). It can be
calculated by working out the inverse value
of the periodic time.
Different types of muscle bres react preferentially to different frequencies:
Slow-response bres tend to react to lower pulse frequencies up to 15Hz, while fastresponse bres only respond to frequencies over approx. 35Hz.
With pulses of approx.45~70Hz, there is permanent tension in the muscle (tetany)
combined with premature muscle fatigue. Higher pulse frequencies can therefore
preferably be used for elasticity and maximum strength training.
For TENS:
A frequency of 110 Hz is good at blocking pain signals.
A low frequency of 4 or 10 Hz allows for the release of endorphins, the body’s natural
morphine-like substances.
5.3 Pulse Width
Pulse width is used to indicate the duration
of an individual pulse in microseconds
(millionths of a second). Pulse width also
determines the penetration depth of the
current. In general a greater muscle mass
requires a greater pulse width. A higher
pulse width is also more likely to activate pain nerves, so there is a ne balance between
maximum muscle stimulation and tolerable sensation.
EMS 50-400 depending on frequency
TENS 50 to 250 μS.
The Flexistim uses only biphasic pulse trains, as they reduce the strain on the muscle,
leading to less muscle fatigue as well as safer application and reduce the risk of skin
irritation under the electrode.
5.2 Pulse Frequency
PERIODIC TIME
PULSE WIDE
MONOPHASE PULSES
PULSE
INTENSITY
BIPHASIC PULSES
PULSE WIDE
INTENSITY
BIPHASIC PULSES
5.4 Pulse Intensity
Setting the degree of intensity is dependent
on the subjective feeling of each individual
user and is determined by a number of
parameters such as application site, skin
circulation, skin thickness as well as quality
of electrode contact. The actual setting
should be effective but should never produce any unpleasant sensation such as pain at
the site of application.
In TENS programmes, while a slight tingling sensation indicates sufcient stimulation
energy, any setting which leads to pain must be avoided.
In EMS programmes, the intensity needs to be as high as possible for maximum benet
– so set just below the pain threshold.
With prolonged application, you may need to increase intensity as nerves get used to the
stimulation and become less sensitive (known as accommodation).
5.5 WORK is the time in seconds that muscle is stimulated (not including Ramp time).
The Flexistim offers a range of work periods from 1-40 sec.
5.6 REST is the time in seconds at zero strength in between stimulation.
The Flexistim offers a range of rest periods from 1-40 sec. The EMS programmes use
an active rest - low frequency pulses help to clear metabolites in-between work periods.
WORK WORKREST
PERIODIC TIME
PULSE WIDE
MONOPHASE PULSES
INTENSITY
PULSE
INTENSITY
RA
MP
RA
MP
BIPHASIC PULSES
5.7 RAMP is the time in seconds taken to
move up and down between zero and the
set stimulation strength. The Flexistim has
a xed ramp time of 1.5 up and 0.75 down.
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6. IFT: WHAT IT IS AND HOW IT WORKS
Many users will be familiar with TENS, which delivers intermittent pulses to stimulate
surface nerves and block the pain signal. Unlike TENS, Interferential Therapy delivers a
continuous stimulation deep into the affected tissue.
IFT achieves this deep penetration by using a 4000Hz carrier wave to overcome the
skin impedance. TENS signals travel around the top 1cm of the skin surface. IFT signals
travel almost directly between the electrodes.
Interferential Therapy uses two medium frequency 4000Hz currents that ‘interfere’ with
each other to produce a beat frequency that the body recognises as a low frequency
energy source.
Unlike TENS, which delivers intermittent pulses to stimulate surface nerves and block the
pain signal, IFT delivers continuous stimulation deep into the affected tissue. In addition
to providing pain relief by the same mechanism that TENS uses, most physiotherapists
consider that IFT’s major role is to accelerate the inammatory or healing rate.
IFT is believed to work by stimulating parasympathetic nerve bres to give increased
blood ow and oedema reduction and by passing currents across cell membranes; these
currents vary depending upon the tissue involved. By using particular frequencies in the
range, different systems within the body can be stimulated or used to increase the blood
supply, which in turn hastens the healing rate. IFT is used to treat almost any condition
where inammation is a problem. For example, sports injuries; arthritic conditions;
bruising and swellings, back pain, osteo-arthritis, rheumatoid arthritis, muscular pain.
Many practitioners use a “Sweep” treatment which uses constantly changing interference
pulse frequency. Practical clinical experience suggests therapeutic benets for these
sweeps in addition to those of conventional nerve stimulation.
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7. MICROCURRENT
MicroCurrent Stimulation (MIC) is a type of therapy where very low current is sent
into the cells of the body. MIC is a very faint current that is so small it is measured in
millionths of an amp (microamps). Human cells generate a current that is in the micro
amp range which is why some can’t feel it - the current is so low it doesn’t stimulate the
sensory nerves.
MIC is a physiological electric modality that increases ATP (energy) production in the
cells of your body. This dramatically increases the tissue’s healing rate. The immediate
response to the correct MIC frequency suggests that other mechanisms are involved as
well. The exact effects or changes in the tissue can be noticeable; scars can suddenly
soften; trigger points often become less painful when the “correct” frequency is applied.
In many situations the changes can be long lasting and even permanent in some cases.
Microcurrent has been shown to give very effective pain relief. In patient surveys over
90% of patients reported signicant improvement.
The results of MIC can be seen after only a minute or so of treatment in most people.
The range of this beat frequency in the Flexistim is 1 to 160Hz
10Hz
12Hz
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13 14
8. KEYPAD AND DISPLAY
Mode Selection Key
Press this key to select the therapy Mode:
TENS
EMS I, II and III (small, medium and large muscles)
IFT
Microcurrent
When a programme is running, this key also acts a PAUSE button. The PAUSE
symbol
II will be displayed and the programme timer will stop. Pressing again
resumes the programme and the intensity gradually returns to the set value.
Programme Selection
Press the “Prog” key to select the programme you require (see section 15)
Parameter Menu Selection
Press these keys to select the following parameters one by one:
TENS Preset Mode (P1-P10) :
Treatment Timer (min)
TENS Manual Mode (P11-P12) :
FREQUENCY (Hz)
PULSE WIDTH (μs)
Treatment Timer (min)
EMS Preset Mode (P1-P09) :
Treatment Timer (min)
EMS Manual Mode (P10-P11) :
FREQUENCY (Hz)
PULSE WIDTH (μs)
SYNCHRONOUS/ALTERNATING - SYNCH/ALT in display
WORK TIME (sec)
REST TIME (sec)
RAMP UP/DOWN TIME (sec)
Treatment Timer (min)
ON/OFF
Channel 1
Intensity mA
Lock
Work/Rest/
Ramp Setting
Channel 2
Intensity mA
Lead Fault
Pause
Frequency
Mode
Pulse Width
Programme
Battery State
Warning
Timer
Keys:
ON/OFF Key (On top of unit)
This key switches the unit on or off.
Press once for 2 sec and the unit is on, 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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Check electrode pad position. If you are certain that the pads are positioned
safely, press the SKIP key to override.
The triangle will stop ashing and intensity can be increased to 60mA.
SKIP key
The EMS programmes have three phases: Warm/ Train/ Cool.
You can jump to the next phase by pressing the Skip key.
In IF MODE, use this key to override limit and set intensity at > 40mA.
15 16
IFT Mode
IFT Preset (P1-P3)
Treatment Timer (min)
IFT Manual (P4)
FREQUENCY (Hz) (P1-P3)
Treatment Timer (min)
Microcurrent Mode:
Preset (P1, P2 and P4)
Manual (P3)
WAVEFORM - Const /Square/Ramp
FREQUENCY (Hz)
PULSE WIDTH mS
Treatment Timer (min)
Parameter Adjustment Controls
Press these keys to increase or decrease the value of the parameter which
you have selected with the MENU keys.
Intensity Controls
Press the keys on the left to adjust the intensity in Ch1 and on the right to
adjust the intensity in Ch2
IF MODE:
I.F. signals penetrate deep into the tissue. Positioning pads across the chest
or head could be dangerous - see section 16.3.
For your safety, when intensity reaches 40mA, the warning triangle ashes
and intensity cannot be increased.
Manual Programme Lock
When “Manual” is showing, you can protect the manual settings by pressing
and holding this key for 3 seconds.
The key symbol will ash and you will be unable to change the manual settings.
Press and hold for 3 seconds to unlock programme.
Lead Fault Detector
In TENS and EMS modes, when one or both of the electrodes are not placed rmly
on the skin, or the leads are not properly connected and the intensity is >10, the
output level goes immediately to zero and a lead fault icon ashes.
Automatic keypad lock
There is an automatic keypad lock if no button is used for 10 seconds.
Key symbol appears.
Press the Intensity Down button for either channel to unlock.
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