TensCare Flexistim IF Instructions For Use Manual

Instructions For Use
Flexistim IF
READ INSTRUCTIONS CAREFULLY BEFORE USE
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FOREWORD Read this User Manual carefully before you start using your Flexistim IF 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 DOES IFT WORK 5
4 KEYPAD AND DISPLAY 7
5 CONTENTS OF THE PACK 12
6 HOW TO ASSEMBLE YOUR UNIT 12
7 OPERATION 15
8 PROGRAMMES 19
9 FURTHER CLINICAL INFORMATION AND TREATMENT PROTOCOLS 20
10 ELECTRODE PAD PLACEMENT 20
11 CARE OF ELECTRODES 22
12 CHARGING THE BATTERY 23
13 TROUBLESHOOTING 24
14 CLEANING 25
15 CONSUMABLES AND SERVICING 25
16 WARRANTY 26
17 DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE) 26
18 SPECIFICATIONS 27
19 STANDARD SYMBOLS 28
20 EMC PRECAUTIONS 28
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1. INTRODUCTION
INTENDED USE
IF stands for Interferential Stimulation. IF is indicated for symptomatic relief of chronic intractable pain.
The Flexistim IF is intended for use in both the Hospital and Home Healthcare Environments.
Flexistim IF provides interferential therapy to treat conditions where inammation is a
problem such as Back Pain, Osteoarthritis, Rheumatoid Arthritis, Muscular Pain / Strain, and Sports injuries, or where deep penetration of low frequency stimulation is required.
Flexistim IF produces a low frequency current treatment that uses two medium frequency currents, which “interfere” with each other to produce a beat frequency that the body recognizes as a low frequency energy source.
The aim is to overcome the problems caused by low-frequency currents, while maintaining their claimed therapeutic effect. Unlike TENS, which delivers intermittent pulses to stimulate surface nerves and block the pain signal, Interferential Current Therapy delivers continuous stimulation deep into the affected tissue.
The actual stimulation is produced by crossing two alternating currents with medium frequencies simultaneously to a targeted body region. As a result, these two currents will superimpose to form a new low frequency current deep within the tissue.
FLEXISTIM IF FEATURES
Flexistim IF includes many of the features of a professional desk-top unit in a compact,
portable, battery operated device.
1. Power Supply
Removeable, rechargeable Li-ion battery, with option of operation through external mains power adaptor.
2. Output
60mA Peak to Peak pure sinusoidal carrier wave with constant energy (modied constant
current) control and 40mA safety override for home use.
1 2
3. Flexible programmes
3 preset and 3 adjustable programmes give a wide selection of treatment options.
4. Memory
Flexistim IF allows you to save and recall a particular programme setting and has a Usage Timer to record the time it has been used.
2. WARNING AND CAUTIONS
Contraindications:
1. Do not use this device on patients who have a cardiac pacemaker, implanted
debrillator, 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, difculty 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 over open wounds or rashes, or over swollen, red, infected,
or inamed 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.
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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.
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 specied 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 can degrade minimum safety.
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.
3
4
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.
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.
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.
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5 6
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.
3. HOW DOES IFT WORK
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 inammatory 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 inammation 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 benets for these
sweeps in addition to those of conventional nerve stimulation.
The range of this beat frequency in the Flexistim F is 1 to 160Hz
10Hz
12Hz
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7 8
4. KEYPAD AND DISPLAY
Programme Selection
Press the “Prog” key to select the programme you require (see section 8)
Parameter Menu Selection
Press these keys to select the following parameters one by one:
In Programme P1:
FREQUENCY (Hz) Treatment Timer (min)
In Programmes P2-P4:
Treatment Timer (min)
In Programmes P5-P6:
Sweep is between High Frequency and Low Frequency over the set Cycle
Time in seconds:
HIGH FREQUENCY (Hz) LOW FREQUENCY (Hz) CYCLE TIME (Sec) 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.
ON/OFF
Lock
Intensity mA
Pause
Beat Frequency
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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