Verity Medical NeuroTrac Simplex User manual
NeuroTrac®Simplex - Operation Manual
1
VERITY
VERITY
MEDICAL LTD
Operators Manual
Visit our website: www.veritymedical.co.uk
for detailed application protocols
NeuroTrac Simplex
®
English
SINGLE CHANNEL EMG
NeuroTrac®Simplex - Operation Manual
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Symbols on the unit
Follow operating instructions! Failure to do so could place the
patient or operator at risk.
This product should be kept dry.
Manufacturer's LOT/Batch number. Present it together
with SN number when you submit the technical fault or
claim warranty return.
Manufacturer's serial number of the unit. Present
it together with LOT number when you submit the
technical fault or claim warranty return.
Name and address of Manufacturer.
Date of manufacture.
Conformity indication with the essential health and
safety requirements set out in European Directives.
0088 - Notied body identication (LRQA Ltd.)
Patient’s shock protection type: BF (Body oated) Equipment.
Floating isolated applied part. It is only intended for
connection to patient’s skin but has oating input
circuits. No connections between patient and earth.
IP20
on the unit
IP -indication for protection against ingress of water and
particulate matter. IP20 means: protected against solid foreign
objects of 12.5mm dia and greater. Non protected against water.
IP02
on the case
IP02 on the carrying case means: Protected from the ingress
of water droplets from a shower of rain.
Do not dispose in normal dustbin (see page 19 for the disposal
instructions).
NeuroTrac®Simplex - Operation Manual
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Contents Page
Unit symbols explanation 2
Warnings 4
Contra-Indication and Precautions 5
Conditions known to respond to EMG 5
Introduction 6
NeuroTrac®Simplex Layout 7
Lead / Electrode connection Assembly 8
Quick Start instructions 9
Threshold and bargraph scaling 11
How to use EMG session 12
Optional PC Software 13
EMG Session settings 15
EMG Session Statistics 16
Lock Function for compliance record 19
Electrodes types and tips 20
Care, Maintenance, Accessories and Disposal 21
Specications 23
Trouble shooting 24
Information regarding Electromagnetic
compatibility and interference (EMC) 25
Warranty 29
Clinical References 30
Table of Contents
NeuroTrac®Simplex - Operation Manual
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* This unit must be used with the guidance of a Physiotherapist or Doctor.
* Type BF equipment, Continuous Operation.
* Do not insert lead wires into a main power supply.
* Do not immerse in water or any other substance.
* The unit is not protect from the ingress of water droplets from a shower
of rain if used outside the carrying case.
* Do not use the NeuroTrac® Simplex in the presence of a ammable
anaesthetic gas mixture and air or with Oxygen or Nitrous Oxide.
* If using rechargeable 9 Volt PP3 Nickel Metal Hydride batteries, be
sure to use a CE approved battery charger. Never connect the
NeuroTrac®Simplex directly to a battery charger or to any other
mains powered equipment.
We advise not to use Ni-Cad rechargeable batteries.
* To avoid the eects of electromagnetic interference never use the
NeuroTrac®Simplex, within 4 metres of a cellular telephone or near any
other powerful radio interference producing equipment that produces
electrical sparks etc. In the EMG Mode, the NeuroTrac®Simplex may
be susceptible to strong interfering radio type emissions that may lead
to temporally increased EMG microvolt readings. The reading will
immediately return to the correct value when the interference ceases.
(Remember that a relaxed muscle should read below 3.5 µVolts).
* Patient Electrodes including all skin surface electrodes Vaginal
Electrodes and rectal probe are for Single Patient Use only.
* Keep out of reach of children.
* No modication of this equipment is allowed!
Warnings
NeuroTrac®Simplex - Operation Manual
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There are no precautions when using EMG other than when being used for
Pelvic oor exercising or assessment. EMG should not be used:
* During menstrual period (when using vaginal probes)
* If symptoms of bladder infection are present
* With patients who have diminished mental capacity or physical
competence who cannot handle the device properly
* Do not place electrodes inside mouth
* The patient should use the unit only as prescribed
* Do not immerse the unit in water or any other liquid
* If in doubt about the use of the NeuroTrac®Simplex unit, call your
Doctor, Therapist, Clinician or you distributor for advice
Contra-Indications and Precautions
Conditions known to respond to EMG
* Pelvic pain
* Patellofemoral pain syndrome
NeuroTrac®Simplex - Operation Manual
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The NeuroTrac®Simplex is a simple to operate low cost single channel EMG
Biofeedback device. The NeuroTrac®Simplex has been developed for its ease
of use, to assist the Therapist and most importantly the Patient to understand
the importance of applying EMG, to enhance the understanding of muscle
activity and to improve muscle conditioning. The NeuroTrac®Simplex also
acts as a diagnostic tool to measure the muscle activity, which is measured in
microvolts [One millionth of Volt].
The NeuroTrac®Simplex is a single channel EMG [Electromyography] device
that has been designed to use with a variety of applications in particular
Incontinence Assessment and Biofeedback Pelvic Floor Training, it can also
be used very eectively for Sports and General Physiotherapy applications.
The NeuroTrac®Simplex is an accurate and sensitive device that measures
muscle activity down to as low as to 0.2 µV [Microvolts] and up to 2000 µV.
The diverse range enables the device to measure very weak muscle activity for
example in accid pelvic oor muscle.
Increasingly, EMG is being used as Therapists and Clinicians alike realise the
importance of measuring muscle activity and individual patient’s progress.
This can be achieved by locking the device, which will record the average
work/rest, onset and muscle release parameters and time in use by patients that
use the NeuroTrac®Simplex at home.
The NeuroTrac®Simplex will stand upright on a at surface enabling the user
to carry out specic exercises and at the same time view the Biofeedback by
way of bright LED lights on the front of the unit. At the end of a session that
may entail ve trials of 5 seconds work and 5 seconds rest of activity, the LCD
screen will automatically display the average muscle readings for the session.
The unit can be locked for a certain period so the patient cannot amend the
treatment parameters such as work/rest time and number of repetitions. When
the unit is then unlocked by therapist, the number of nished sessions is
displayed together with the overall average readings.
In addition, the unit can be used with the optional PC Software.
Introduction
NeuroTrac®Simplex - Operation Manual
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NeuroTrac®Simplex Layout
ON / OFF
Button
Pressing the Start
button initiates a
programme
Pressing the
Escape button
once will bring
you back to
home screen.
Battery
Compartment
Concealed button, Locks the
programme and records information.
Press and hold for 5 seconds to Unlock.
Increases EMG
threshold, or
alters the
parameters
when setting up
a programme
Decreases the EMG
threshold, or alters
the parameters
when setting up a
programme
Press and hold SET
for 3 seconds to
adjust the session
parameters, such
as Work/Rest time,
number of trials, etc.
Press SET
button to adjust
the threshold
automatically
(contract the
muscles for 3
seconds and the
unit will set the
most suitable
bargraph scale).
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Lead / Electrode
Connection Assembly
Optional Vaginal
Probe
Always place reference (REF) wire anywhere on your body, for
example on a hip or forearm. This third electrode will allow a precise
EMG measurement, if you don’t use this electrode your reading will be
unstable and meaningless.
EMG
Reference
Electrode
This unit can be connected to the
optional PC Software via BlueTooth
connection. Read more on page 13,
also page 24.
EMG
Electrodes
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1. Remove battery cover. Insert 1 x 9 volt PP3
battery or a rechargeable Nickel Metal Hydride
battery into the battery compartment. Replace
the cover.
2. Insert the dual-conductor (channel) lead wire
into the socket of the unit labelled as INPUT.
For a precise EMG measurement, ALWAYS!
use the reference wire: attach one skin
electrode to a black single leadwire (reference
wire) and plug the reference wire to the EMG
REF socket.
3. If you use Simplex with Vaginal or Rectal
electrode probe, remove the probe from
the package and follow the probe labelling.
Connect the Vaginal or Rectal electrode to
each of the pin connectors at the end of the
lead wire. The red and black polarity are good
either way. Some probes have a long wire built-
in, with a direct socket to the unit.
* Make sure the Vaginal or Rectal electrode
is clean before use.
* Insert the Vaginal or Rectal electrode using
KY jelly or any other water-based lube (not
mandatory).
* A typical vaginal electrode placement
diagram: Don’t insert too deep, the neck of
the probe should be just inside the vagina,
the metal plates of the probe should be
fully inserted.
4. For Skin electrodes placement, make
sure your skin around the treatment area is
free from grease or oil. Carefully peel the
electrodes from the clear plastic lm. Do
not throw this clear plastic lm away. Attach
the electrodes to your body. Place negative
Black-pin near the upper insertion or top of
the muscle. Positive Red-pin must be placed at
the motor point of the muscle. The motor point
is usually located at the centre of the muscle
mass where the motor nerve enters the muscle.
Find the best position by slightly moving the
Quick Start Instructions
not in EMG REF
use
P
E
L
V
I
C
F
L
O
O
R
Vaginal Probe
(NeuroTrac®
VeriProbe)
Rectum
Uterus
NeuroTrac®Simplex - Operation Manual
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positive electrode around. Your objective is to nd the spot where the
minimum muscle contraction will cause the greater EMG response.
5. Turn on the unit by pressing the ON/OFF button. Place the unit on a desk
in its stand or hold the unit. Relax so that the microvolts reading is as low
as you can manage, ideally below 1uV.
6. Press SET and contract as high as you can for 3 seconds to adjust the
Threshold automatically (see next chapter for threshold automatic and
manual operation). The threshold level should match your current muscle
performance, so when you contract and then relax, the bargraph should go
the full scale up and down in accordance with your movements.
7. To start the programme, press the START/ESC button.
Follow the audio and display prompts: relax as much as you can when you
hear single beep sound and the display shows arrow down. Contract as fast
and as much as you can when you hear double beep sound and the display
shows the arrow up.
To end the programme before it is complete, press the START/ESC but-
ton again or turn the unit o.
8. When you have nished, remove and replace the electrodes onto the
clear plastic lm and reseal them in the plastic bag.
If you are using a VeriProbe, clean the probe and let it dry before
sealing it in its plastic bag.
9. Store the electrodes in a cool dry place, such as a fridge, which prolongs
the life of your electrodes.
NeuroTrac®Simplex - Operation Manual
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Threshold and bargraph scaling
Press SET for auto threshold adjustment
Relax so that the microvolts reading is as low as you can manage, ideally
below 1uV.
Press SET and contract your muscles for up to 5 seconds as high as you can.
The display shows the up arrow segment ashing and the seconds are counting
down 3, 2, 1 on the display. Finally the new threshold value is displayed. This
value is calculated as 80% of your average contraction during the time of the
above 5 seconds measurement. You can repeat the adjustment as many times
as you want simply by pressing again the SET button and contracting your
muscles again for up to 5 seconds.
The threshold value regulates the full bar graph scale of your Simplex. For
example, for the weak or small muscle groups the bar graph should be more
sensitive (threshold value 0-20µV) then for stronger muscles (threshold
above 20µV). The best way to select the threshold you need is to use the auto
threshold function described above.
Note! You need to be in the home screen of Simplex for SET button to initiate
the automatic threshold adjustment. Turn the power OFF, then turn the power
back ON to go to the home screen.
You can always adjust the threshold manually simply by pressing +/- buttons.
Bargraph
Threshold pointer.
Threshold value.
Your actual EMG reading.
T: Number of Trials tells
you how many cycles is left
till the end of the exercise.
This timer shows how long
you should stay relaxed
[contracted].
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How to use EMG session
Your Simplex device is designed to perform a series of voluntary contraction
(Work) and relaxation (Rest) exercises. The contraction/relaxation is repeated
many times (Trials) and the whole procedure is called a session. Press the Start
button and follow the on-screen and audio prompts which tell you when you
should contract and when to relax. By the end of the session, the statistics are
displayed. The session can be used as training or assessment.
EMG Biofeedback Training is used to facilitate the rehabilitation by allowing
the patient a visual (bargraph and EMG µV reading) and an audio (beeps)
representation of his/her actual muscular performance. Once you hear and see
the muscle during the voluntary attempts to contract and then to relax, you
can consciously develop the ability you need (faster relaxation, stronger hold,
quicker response, etc). Typically you would use a training session intensively
for several times a day or cautiously for several times a week.
EMG Biofeedback Assessment is used when the performance results
(statistics) are needed to be collected for a periodic comparison. You press
the START button to use the session not for a regular training but now for the
examination. Upon a completed session, the statistical results are displayed
(see the Statistics chapter).
NeuroTrac®Simplex - Operation Manual
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Optional PC Software
Try out the latest software from www.neurotrac.emgsoft.info
There are many useful features you can have with the PC Software, some of
them are listed below:
EMG games - a range of Biofeedback Games designed for children and adults
for a graphical encouragement of daily training routines.
Template Training - a custom template curve can be drawn for the patient to
follow, so you can create your own relaxation, rapid contraction protocols, etc.
Work/Rest Assessment - this feature allows the periodic progress records to
be stored in the database and printed out to establish the results and tendencies
of biofeedback or any other (additional) on-going rehabilitation protocols.
Below are some screen-shots of selected Software features:
Patient’s database stores all Assessments and Trainings records if your Simplex
was linked to the PC during the session. The software can handle as many
patients as you need with virtually unlimited record capacity (subject to your
computer limitations).
NeuroTrac®Simplex - Operation Manual
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The Template Training allows you to draw the curve, adjust it’s thickness,
repeat it as many times as you need and this will form a pattern called
“Template“ which the patient follows with his/her EMG.
The Progress Report can be created from the records of assessment sessions
previously recorded in PC Software. The graphical comparison allows the
progress details to be revealed for a proper evaluation of the rehabilitation
results.
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EMG Session settings
EMG
parameters Text on
LCD Available settings
Sound Volume VOL
Value range: 0 - sound o, 1,2,3,4,5 - quiet, 5,6,7,8,9,10
- loud.
Typical value: 4.
This is the sound volume of beeps and prompts: Work,
Rest, Lock, PC-CONNECT, Erase
Work Time WRK
Value range: [sec]: 2,3,4, ..., 99
Typical value: 5.
This is the time during which the patient is prompted
to keep the measured muscles contracted above the
threshold level.
Rest Time RST
Value range: [sec]: 2,3,4, ..., 99.
Typical value: 5.
This is the time during which the patient is prompted to
keep the measured muscles relaxed below the threshold
level, ideally below 1uV.
Number of
Trials TRS
Value range: 2,3,.., 99.
Typical value: 5.
This parameter denes how many repetitions of Work/
Rest cycles your treatment requires.
Audio
Biofeedback
type
FAB
FBL
FCO
FOF
Select from the following:
FAB - the EMG beeps will be audiable only above the
threshold.
FBL - the EMG beeps will be audiable only below the
threshold.
FCO - the EMG beeps will be audiable above and
below the threshold
FOF - no EMG beeps. Typical setting: FAB.
PC Data
output
DON
DOF
Select from the following:
DON: - switch ON to enable PC Software connection.
DOF: - switch OFF to save batteries.
Typical setting: DON.
EMG Notch
Filter
WDE
NRW
Select from the following:
WDE (typical setting) - wide lter - your EMG reading will
be more sensitive but it will also pick up heart beats.
NRW - narrow lter - your EMG reading will be ltered
to reduce the heart beat spikes on the EMG reading. Use
narrow lter if your electrodes are in close proximity to
heart (on chest, back, arms, vaginally or rectally).
To adjust the session parameters, press and hold SET button for 3 seconds.
The rst parameter will be VOL (sound volume). To adjust the value, press
+/- buttons. To go to the next parameter in the table below, press SET button.
To save new settings, simply press ESC or OFF. The new settings will be
immediately stored.
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EMG Session Statistics
The EMG session statistics are used for assessment of muscular activities.
Start the session, follow the on-screen prompts, by the end of the session the
following statistics will be displayed. Press SET to scroll down the list of
statistics.
SE and T are displayed only when the unit is locked.
SE - the number of completed sessions when the unit
was locked. If no sessions were completed and you
unlock the unit, SE will read zero and it will be the only
statistics screen you would see, as nothing else to be
presented.
T - number of trials set for a session.
Work Average [µV] - the overall average microvolts
achieved during all work periods of the session.
Generally the higher the Work average is, the better the
muscle performance.
Assessment: the good progress is when Work average
is getting higher and higher each day.
20
SE
T
5
WAV
67.0uv
RAV
0.8uv
Rest Average [µV] - the overall average microvolts
during all rest periods of the session.
Generally the lower the Rest average is, the better the
muscle performance. It is very important how low you
can relax your muscles in terms of microvolts. Below
4µV a muscle is beginning to rest. If the Rest average is
above 4µV make sure you use the EMG reference lead
wire! The reading above 4µV commonly means the
muscle is overstimulated or tired after a longer EMG
training session.
Assessment: a good progress is when the Rest average
is getting lower and lower each day.
Microvolts PROMPTS
inicial rest
“WRK” “RST” “RST”
“WRK”
WORK.1 REST.1 WORK.2 REST.2
release.1
onset.1
release.2
onset.2
[2 x Trials of: 4 sec Work and 4 sec Rest]
Time
[sec]
NeuroTrac®Simplex - Operation Manual
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OST
4
5
0.3 Sec
Onset Average [sec] - This is the average time taken in
seconds to achieve 75% of the work average of all work
segments, any values over 2 seconds are ignored.
Generally this parameter measures how fast you can
contract a muscle, the shorter the Onset average
time is, the better the muscle performance. Reading
below 1 second can be considered normal. The time it
takes to contract a muscle gives an indication on the
recruitment of the fast twitch bres. If the onset time
was slow, the recruitment percentage of the fast twitch
bres would be less than if the onset time was faster.
Assessment: the good progress is when Onset average
time is getting shorter and shorter each day.
RLS
3
5
1.5 Sec
Number of valid releases (invalid releases of over
2 seconds are ignored from RLS calculation)
Number of all releases (= number of trials)
Release Average [sec] - This is the average time taken
in seconds to relax below 37.5% of the work average
of all work segments, any values over 2 seconds are
ignored.
Generally this parameter measures how fast you can
relax a muscle, the shorter the Release average time is,
the better the muscle performance.
Healthy muscle normally reverts back to a low resting
EMG value in less than one second. If the muscle
takes longer to revert back to rest then there will be a
reason, such as muscle or nerve damage or some other
underlying problem.
Assessment: the good progress is when Release
average time getting shorter and shorter each day.
Number of valid onsets (invalid onsets of over 2
seconds are ignored from OST calculation)
Number of all onsets (= number of trials)
NeuroTrac®Simplex - Operation Manual
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PK
250uv
Peak value [µV] - This is the maximal muscle
contraction over the session. This information is less
important for the overall analysis.
WDV
11.7uv
RDV
08.2uv
Work Average deviation [µV] - The average deviation
in microvolts of the work periods of the session, it
excludes the rst second of each work portion.
Generally the deviation means the average dierences
between EMG readings.
If a muscle shakes and contracts spasmodically, the
EMG graph is sharp and wavy (high EMG deviation). If
the muscle is not tired and in good shape, it doesn’t
tremble and stays rm in contraction, the EMG graph
will be smother (low EMG deviation).
Assessment: the good progress is when Work
Deviation % value is getting smaller and smaller each
day.
Rest Average deviation [µV] - The average deviation
in microvolts of the rest periods of the session, it
excludes the rst second of each rest portion.
Generally the high Rest average deviation means
overstimulated or overtrained muscle or the body has
diculties in controlling the muscle because of the
damage of the motor neurons.
Assessment: the good progress is when Rest
Deviation % value is getting smaller and smaller each
day.
Warning! All suggested assessment criteria on page 14-16 is not necessarily
the case for every imaginable treatment. Given examples of how you should
analise the statistical results cannot be considered as complete or always true,
the aim is to give the initial idea and a point of reference for the beginners in
EMG analysis. Please seek the advice among specialists.
NeuroTrac®Simplex - Operation Manual
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Lock Function for compliance record
Concealed Button
to Lock and
Record a Patients
Compliance
The LOCK function locks the treatment for home or in-clinic use. When the
unit is locked, user cannot amend any crucial treatment settings such as Work
time, Rest time, number of trials and EMG notch lter. However user at home
can still adjust threshold, sound volume, change the audio biofeedback type,
or switch ON/OFF the link to PC. When the unit is locked, the statistics are
gathered and averaged to cover the whole treatment. Simplex has no ability
to show the statistics day by day, it averages all the statistics of up to 1999
sessions. The sessions over 2000 will not be included ( ignored) in the overall
statistics record.
Locking instructions:
1-Lock (double beep)
Please programme the treatment you want and press the concealed button to
lock the unit. The lock symbol will appear on the display. From this moment
the overall statistics are gathered. For example, if you lock and complete 10
sessions during a couple of weeks, the unit displays the number of completed
sessions [SE], the overall average work of these 10 sessions, the overall
average rest, the overall average onset and release, the overall average work
and rest deviation.
2-Statistics review (single beep)
Press the concealed button one more time to
review the overall statistics. Press SET to scroll
down the list of available statistics.
You can connect the unit to PC Software to
download the statistical information you see on
LCD screen. You can press ESC or OFF and the
unit will remain locked and statistics not erased
3- Unlock and clear
(5 beeps, the last one is longer)
When in Statistics review, press and hold the
concealed button for 5 seconds to unlock the unit
and erase the statistics. The unit is now ready to be
programmed for another treatment.
NeuroTrac®Simplex - Operation Manual
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* Self-Adhesive reusable long-term electrodes (if looked after) have a
typical life span of 4/6 weeks. We recommend cleaning the skin with an
alcohol-based wipe before placing the electrodes. The wipe should not
contain fat as any grease will degrade the electrode stickiness. After use,
place the electrodes back onto the plastic lm and in the zip-tag plastic
pouch. Store in a cool environment which is not too dry.
Skin Electrode Types Available:
Electrodes Types and Tips
A Few Good Tips [Self- Adhesive Electrodes]
* If you nd the electrodes will not stick due to oily skin, cleanse the
skin with soap and water, then rinse and dry the area around the
electrode site. If this does not work, try cleansing the skin with a swab
impregnated with alcohol.
* Clip away hairy skin using scissors; don’t use a razor
to remove the hairs!
* The electrodes conductive material is water- based. If it becomes
saturated (e.g. from perspiration), it will lose its adhesive qualities.
After use leave the electrodes face up overnight to dry out (replace on
plastic lm in the morning).
At some point the electrodes will become dry. Moisten the adhesive
surface with a few drops of water, and apply onto the plastic lm
overnight. This procedure will increase the electrode life by few more
days.
SHAPE CODE DESCRIPTION
VS.4040 40 x 40 mm, square [** max
53mA]
VS.5050 "50 x50 mm, square
(recommended for general use)"
VS.9040 90x40mm, rectangular
VS.9050 90 x 50 mm, rectangular
VS.10050 100 x 50 mm, rectangular
VS.30 30mm diameter, round
[** max 46mA]
VS.50 50 mm diameter, round
** IMPORTANT : Don’t use VS 4040 at more than 53mA
and VS3030 at more than 46 mA.
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