Med-Fit 3 User manual

med fit
Med-Fit 3
Instruction M nu l
Betriebs nleitung
M nuel d’instruction

Skin Prep r tion
Before Applic tion of Self-Adhesive Electrodes
For best results ple se w sh the re to be tre ted with solution of
w rm s lt w ter (mix one t blespoon of s lt in w rm w ter) nd rub the
re with the s lt solution.
The procedure will m ximise the effect of the Tens when pplied to re s
of the body, where the skin m y be p rticul rly dry.
Apprêtement de l pe u
Av nt pplic tion des électrodes uto- dhésives
Pour obtenir de meilleurs résult ts, veuillez l ver votre pe u d ns les
zones à tr iter vec de l’e u s lée ch ude (mél ngez une cuillère à
soupe de sel à de l’e u ch ude) et frottez l zone vec l solution.
L procédure permettr d’optimiser les effets de l’ pp reil TENS une fois
ppliqué sur votre corps, ux endroits où l pe u peut être
p rticulièrement sèche.
Vorbereitung der H ut
Vor Anbringung der selbstklebenden Elektroden
W schen Sie die zu beh ndelnde Stelle mit einer S lzw sserlösung
(einen Esslöffel S lz in w rmem W sser uflösen) und reiben Sie die
Stelle mit der S lzlösung ein, um optim le Result te zu erzielen.
Dieses Verf hren optimiert den Effekt der TENS-Beh ndlung n
Körperstellen, wo die H ut unter Umständen besonders trocken ist.

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INDEX
Chapter Contents Page
2. Warnings & Precautions .............................................. 2
1. General Description ..................................................... 2
3. Control Layout .............................................................. 4
4. ............................................. 5
5. Accessories .................................................................. 6
6. Graphic Symbols .......................................................... 7
7. Parameter Controls ...................................................... 7
8. Attachment of Electrodes Lead Wires ....................... 10
9. Preparation for use ...................................................... 10
10. Application of Re-usable Self Adhesive
Electrodes ..................................................................... 11
11. Adjusting the Controls ................................................ 12
12. Battery Information ...................................................... 15
13. Safety-technical Controls ............................................ 15
14. Conformity to Safety Standards ................................. 16
15. Warranty ........................................................................ 16
Manufacturer ................................................................ 16
Representative in the EU ............................................. 16
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Chapter 2: WARNINGS AND PRECAUTIONS
PLEASE NOTE:
It is imperative that patients read and understand the warnings and
precautions before using the unit. Do not allow your machine or
electrodes to be used by anyone else, as they are designed for single
patients use only. It is recommended that proper medical advice
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therapist, Doctor or Nurse) prior to use, in order to ensure safe and
effective treatment. If you are taking any medication please carry on
as normal but seek advice from your clinician before using the device.
WARNING! PATIENTS WITH PACEMAKER MAY NOT BE TREATED
WITH TENS
• Do not use during pregnancy except during labour
• 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.
Chapter 1 : GENERAL DESCRIPTION
The MED-FIT 3 is a battery operated pulse generator that sends
electrical impulses to the body by means of electrodes attached to
the skin.
The device has two independently controllable channels. A pair of
electrodes can be connected to each channel.
The electronics of the MED-FIT 3 creates electrical impulses whose
Intensity, duration, number per second and modulation may be
altered with the controls or switches. Dial controls are very easy to
use and the slide cover prevents accidental changes to the settings.
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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.
The degree of pain relief declines in some cases with time, TENS
may have less effect after extended use. To reduce the risk of development
of tolerance, the following measures may be taken:
• Frequent follow-ups.
• Teach the patient to use burst, modulated, and conventional
stimulation.
• Vary electrode placement.
• Vary the frequency
If none of the above are successful discontinue TENS for up to 2
weeks and then resume stimulation.
As with pain-killing medicines, TENS provides temporary pain relief,
which often lasts up to four hours after treatment. Treatment usually
lasts 30-60 minutes, 2-4 times daily.
The time taken to achieve pain relief varies from an immediate effect
up to about an hour. Some patients prefer continuous stimulation
while others prefer intermittent stimulation with different intervals.
Remove the electrodes and discontinue stimulation if you experi-
ence skin irritation or discomfort.
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Chapter 3 : CONTROL LAYOUT
LIQUID CRYSTAL DISPLAY
(2) LEAD CONNECTOR
(3) INTENSITY CONTROL
(OUTPUT ON/OFF SWITCH)
(4) LCD
(5) PULSE RATE CONTROL
(6) PULSE WIDTH CONTROL
(7) MODE CONTROL
(8) BATTERY STRIP
(9) BATTERY CASE
(10) BELT CLIP
(1) OUTPUT INDICATION
(2) MODE
(3) PULSE RATE
(4) PULSE WIDTH
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Chapter 4 : TECHNICAL SPECIFICATIONS
MECHANISM TECHNICAL DESCRIPTION
01. Channel Dual, isolated between channels.
02. Pulse Amplitude Adjustable 0-80mA, Max output 80mA peak to peak
(15.8mA rms) into 500ohm load each channel.
03. Output Voltage Adjustable 0-40V, Max output 40V peak to peak (7.9V
rms) into 500ohm load each channel.
04. Wave Form Asymmetrical Bi-Phase Square Pulse.
05. Power Supply One 9 V battery (006P 9V)
06. Size 10cm(L) x 6cm(W) x 2.1cm(H)
07. Weight 120 grams with battery
08. Pulse Rate Adjustable, 1 ~ 150 Hz
09. Pulse Width Adjustable, 30 ~ 260µs
10. Mode Five modes of options, B,N,M,S1,S2 (N= Normal)
11. Burst mode Burst Rate adjustable, 0.5 ~ 5 Hz
(B Mode) Pulse Width adjustable, 30 ~ 260µs
12. Modulation Pulse rate is automatically varied in a cyclic pattern
over a nominal 10 second interval (in max 150Hz). Pulse
rate decreases linearly, over a period of 4 seconds,
from the control setting value to a value which is 40%
less. The lower pulse rate will continue for 1 second and
then the pulse rate increases linearly over a period of 4
seconds to the original value. This will continue for 1
second and the cycle is then repeated
13. SD1 Mode
Pulse width is automatically varied in a cyclic pattern
over an interval of nominally 10 seconds. (in max 260µs)
Pulse width decreases linearly over a period of 4
seconds from the control setting value to a value which
is 40% less. The narrower pulse width continues for 1
second and then increases linearly over a 4 seconds
period to its original value. This will continue for 1 sec
ond and the cycle is then repeated
14 SD2 Mode Pulse width is automatically varied in a cyclic pattern
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over an interval of nominally 10 seconds. (in max 260µs)
Pulse width decreases linearly over a period of 4
seconds from the control setting value to a value which
is 70% less. The narrower pulse width continues for 1
second and then increases linearly over a 4 seconds
period to its original value. This will continue for 1
second and the cycle is then repeated
Chapter 5 : ACCESSORIES
Each set MED-FIT 3 are completed with standard accessories and
standard label as given below
I. Accessories
REF. NO. DESCRIPTION Q’TY
1. SA 10 50 X 50 MM Adhesive Electrodes 4 pieces
2. Electrodes Leads 2 pieces
3. 9 V Battery, type 6F22 1 piece
4. Instruction Manual 1 piece
II.LABEL
The label attached to the back of
the unit contains important infor-
mation this model, serial number,
supply voltage, the name of manu-
facturer, CE number and classifi-
cation. Please do not remove.
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Chapter 6 : GRAPHIC SYMBOLS
1. Note Operating Instructions
2. Degree of Electrical Protection BF
3. Do not insert the plug into AC power supply socket.
4. Pulse Rate
5. Pulse Width
6. Increase Parameter
7. Decrease Parameter
8. Direct Current (DC power source)
9. Consult Instructions for use
10. Manufacturer
11. Serial Number
Chapter 7 : PARAMETER CONTROLS
PULSE DURATION
Wider pulse duration settings will deliver stronger stimulation for any
given intensity setting. As mentioned in the Controls section, by using
a combination of intensity and pulse duration different groups of
The choice of which pulse duration to use is partially dependent
upon the Treatment Mode and Protocol selected (refer to the appropriate
section).
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PULSE RATE
The Pulse Rate (frequency, pulses per second or Hertz) is thought
to determine whether the spinal gating mechanism or the endorphin
release mechanism is activated.
As a rough guide the higher frequencies, those above 70Hz, will activate
the spinal gating mechanism. The patient will perceive a "pins and
needles" sensation.
Lower frequencies, those between 2-16Hz, will activate the endorphin
release mechanism. The patient will perceive a "tapping" sensation.
It should be noted that individual patients vary in their response to
TENS and the practitioner should be prepared to experiment with
different settings in order to obtain the most effective response.
TREATMENT MODE
Normal or Conventional TENS offers the practitioners complete control
over all the various treatment parameters of the instrument.
Burst Mode is analogous to the Low Rate TENS technique except
the low frequency individual pulses are replaced by individual
"bursts" of 7-10 individual pulses. It is thus a combination of Conventional
TENS and Low Rate TENS. In Burst Mode, the treatment frequency
Rate control.
Modulated Mode attempts to prevent nerve accommodation by
continuously cycling the treatment intensity. When using Modulated
Mode increase the intensity only when the unit is at the maximum
intensity of the modulation cycle. If the intensity is increased during
a low intensity period of the cycle the resulting stimulation may
cause discomfort.
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INTENSITY
Each patient responds differently to different levels of intensity, due
to varying degrees of tissue resistance, innnervation, skin thickness,
etc. Intensity instructions are therefore limited to the following set-
tings: Perception - The intensity is increased so that the patient can
feel the stimulation, but there is no muscular contraction.
Slight Contraction - Intensity is increased to a barely visible mus-
cular contraction that is not strong enough to move a joint. When
using low pulse rate settings, this will show as individual twitches.
At higher pulse rates there will simply be increased muscle tension.
Strong muscular contraction is typically not used in TENS therapy.
However, muscular contraction may be useful if the pain involves a
cramped or spastic muscle.The TENS can be used as a traditional
muscle stimulator in the circumstances to quickly break the spasm.
Use a rapid pulse rate, wide pulse duration and set the intensity to
visible contraction (still within patient tolerance). Twenty or thirty
minutes of such a tetanized muscular contraction will generally
break the spasm. In all cases, if the patient complains that the stimulation
is uncomfortable, reduce intensity and/or cease stimulation.
TIME DURATION
The onset of pain relief should occur shortly after the intensity set-
ting has been determined. However, in some cases, pain relief may
take as long as 30 minutes to achieve especially when using low-
frequency TENS.TENS units are typically operated for long periods
of time, with a minimum of 20 - 30 minutes and in some post-opera-
tive protocols, as long as 36 hours.
In general, pain relief will diminish within 30 minutes of the cessation
of stimulation. Pain relief obtained through low-frequency TENS
may last longer.
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Chapter 8 : ATTACHMENT OF ELECTRODE
LEAD WIRES
The wires provided with the system insert into the jack sockets lo-
cated on top of the device. Holding the insulated portion of the con-
nector, push the plug into one of the jacks (see drawing); one or two
sets of wires may be used.
After connecting the wires to the stimulator, attach each wire to an
electrode. Take care when you attach and detach the wires. Jerk-
ing the wire instead of holding the insulated connector body may
cause wire breakage.
CAUTION
Do not insert the plug of the patient lead wire into the AC power
supply socket.
Chapter 9 : PREPARATION FOR USE
It is recommended that for persons with sensitive skin, the area is
prepared prior to the application of the self adhesive electrodes by
cleaning using soap and water or alcohol wipes and then drying
thoroughly. It is quite normal to see a reddening of the skin underneath
the electrodes following treatment but this usually disappears in less
than 2 hours.
If the reddening persists we recommend PALS (BLUE) electrodes
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Chapter 10 : APPLICATION OF RE-USABLE SELF
ADHESIVE ELECTRODES
Application
1.
Clean and dry the skin at the thoroughly with soap and water prior
to application of electrodes.
2. Insert the lead wire into the pin connector on the pre-wired
electrodes.
3. Remove the electrodes from the protective liner and apply the
Removal
1. Peel the electrodes from the skin; do not pull on the lead wires
because it may damage the electrodes.
2. Place the electrodes on the liner and remove the lead wire by
gently twisting and pulling.
Care and Storage
1. Between uses, store the electrodes on their liner in the re-seal
able bag in a cool dry place.
2. The adhesive properties of the electrodes may be improved by
applying a few drops of cold water and allowing the electrode
surface to dry. Do NOT soak the electrodes.
Important
1. Do not apply to broken skin.
2. The electrodes should be discarded when they no longer adhere.
3. The electrodes are intended for single patient use only.
4. If irritation occurs, discontinue use and consult your clinician.
5. Read the instruction for use of self-adhesive electrodes before
application.
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Chapter 11 : ADJUSTING THE CONTROLS
1. Slide Cover
A sliding panel covers the controls for Pulse Width,
Pulse Rate, Mode Selector and Modulation Selector.
Take advice from your clinician regarding the settings
and then leave the cover in place.
2. Power On/Off Switch and Intensity Control
If both controls are in the off position the device is inactive
Turn the controls clockwise to activate the unit. A
black dot appears in the LED to indicate that stimulation
has commenced. The intensity increases as the
control is turned further clockwise.
In order to reduce the intensity or to switch the unit off turn the con-
trol anti-clockwise.
3. Lead Connector
Ensure that the unit is switched off. Connect the electrodes to the
lead by inserting the plugs into the electrode connectors. Plug the
lead into the unit and press the
S
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4. Mode Control
Expose the controls by sliding front cover down from top of unit.
This button controls 5 modes: B for burst, N for constant, and M
for pulse rate modulation (-40%) stimulation, S1 for pulse width
modulation(-40%), S2 for pulse width modulation(-70%). Select the
required mode
5. Pulse Rate Control
Pulse rate is adjustable from 2Hz to 150 Hz. The value is displayed
on the LCD. This control determines the frequency (pulses per sec-
ond) of the electrical impulses. Unless otherwise instructed set the
control to between 70 - 120Hz
When this button is pressed the pulse rate gradually increases
When this button is pressed the pulse rate gradually decreases
6. Pulse Width Control
This control adjusts the length of each electrical impulse. By in-
creasing the pulse width the strength and sensation of the stimulus
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will be increased. By reducing the pulse width the strength and sen-
sation will be reduced. Unless otherwise instructed set the control
to between 70 - 120 µs.
When this button is pressed the pulse width gradually increases
When this button is pressed the pulse width gradually decreases
7. The device will store the mode that is used before it is switched off .
8. Check/Replace the Battery:
Over time, in order to ensure the functional safety of TENS,
changing
the battery is necessary.
1. Make sure that both intensity controls are in the off position
2. Slide the battery compartment cover and
remove.
3. Remove the battery from the compartment.
4. Insert the battery into the compartment.
Note the polarity indicated
on the battery
and in the compartment.
5. Replace the battery compartment cover
and slide to close
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Chapter 12 : BATTERY INFORMATION
PRECATIONS
1.
Remove battery if equipment is not likely to be used for some time.
2. Please recycle the used battery in accordance with domestic
regulation.
3.
Chapter 13 : SAFETY-TECHNICAL CONTROLS
For safety reasons, check your MED-FIT 3 TENS each week based
on the following checklist.
1. Check the device for external damage.
- deformation of the housing.
- damaged or defective output sockets.
2. Check the device for defective operating elements.
- legibility of inscriptions and labels.
- make sure the inscriptions and labels are not distorted.
3. Check the usability of accessories.
- patient cable undamaged.
- electrodes undamaged.
Please consult your distributor if there are any problems with device
and accessories.
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Chapter 14 : CONFORMITY TO SAFETY
STANDARDS
The MED-FIT 3 devices are in compliance with the
EN 60601-1-2:2001 and EN 60601-1:1990+A1:1993+A2:1995
+A13:1996 safety standards.
Chapter 15 : WARRANTY
All MED-FIT 3 carry a warranty of one year from the date of de-
livery. The warranty applies to the stimulator only and covers both
parts and labour relating thereto.
The warranty does not apply to damage resulting from failure to
follow the operating instructions, accidents, abuse, alteration or dis-
assembly by unauthorized personnel.
Manufacturer:
Everyway Medical Instruments Co., Ltd.
3F., No.5, Ln. 155, Sec. 3, Beishen Rd.,
Shenkeng Dist., New Taipei City 22203,
Taiwan. (R.O.C.)
Representative in the EU:
REHAB EUROPA SL
SANT GERVASI DE CASSOLES, 96 3o4a
08022 BARCELONA, SPAIN.
INFORMATION FOR DISTRIBUTOR:
Please contact the above mentioned manufacturer for technical
support and documentation when necessary.
7601E83C02
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Inhaltsverzeichnis
Kapitel
1. TENS – Die Alternative gegen Schmerz..................18
2. Wie das TENS-Gerät arbeitet..............................18
3. Bei welchen Indikationen hilft TENS? ...................19
4. Wann sollte TENS nicht angewendet werden?.........19
5. Die Bedienelemente des TENS-Gerätes .................20
6. TENS im Einsatz – Schritt für Schritt ....................21
7. Anwendungsbeispiele für TENS...........................22
8. Die Bedienung im Detail ...................................22
9. Die Behandlung im Detail ..................................26
10.Drei individuelle Stimulationsformen ...................27
11.Der Umgang mit den Elektroden..........................28
12.Die Positionierung der Elektroden .......................29
13. Wartung, Lagerung und Transport .......................30
14. Lieferumfang / Zubehör....................................30
15. Technische Angaben ........................................31
16. ..................................................................
Sicherheitskontrolle.............................................32
17. Störungen .....................................................32
18. ..................................................................
Zeichenerklärung ................................................32
19. Garantie .......................................................33
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1. TENS - Die Alternative gegen Schmerz
Die Transkutane Elektrische Nervenstimulation – kurz TENS-Therapie
genannt – ist eine anerkannte, klinisch geprüfte Methode zur Linde-
rung von akuten und chronischen Schmerzen. Als äußerlich anwend-
bare und medikamentenfreie Behandlungsform, sicher und einfach in
der Handhabung, genießt sie das Vertrauen vieler Patienten.
Die elektrischen Impulse von TENS bewirken eine Hemmung der
Schmerzübertragung zum Gehirn und führen zu einer erhöhten Aus-
schüttung von Endorphin, einem Hormon, das schmerzlindernd wirkt.
2. Wie das TENS-Gerät arbeitet
Ihr Arzt hat Ihnen ein TENS-Gerät von Pro Medica Homecare zur
Schmerztherapie verschrieben. Das batteriebetriebene Gerät er-
zeugt elektrische Impulse, die mit Hilfe von Elektroden in den Körper
gesendet werden, bis hin zu den Schmerz erzeugenden Nerven. Diese
Impulse sind in Intensität, Dauer, Frequenz und Modulation indivi-
duell regelbar. Sie erhalten jedoch ein auf Ihre Therapiebedürfnisse
voreingestelltes Gerät. Die Einstellungen erkennen Sie leicht auf
dem übersichtlichen Display.
Der TENS-Generator ist mit zwei einzeln kontrollier- und regelbaren
Ausgangskanälen ausgestattet. An jeden dieser Ausgangskanäle kön-
nen Sie ein Elektrodenpaar anschließen – für den maximalen Erfolg
Ihrer Therapie.
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