Verity Medical NeuroTrac Continence User manual

NeuroTrac®Continence Operation Manual
1
DUAL CHANNEL STIM UNIT
Operators Manual
Visit our website: www.veritymedical.co.uk
for detailed application protocols
English
NeuroTrac Continence
®

NeuroTrac® Continence Operation Manual
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Symbols on the unit and case
Caution! (electrical output).
Follow operating instructions! Failure to do so could place
the patient or operator at risk.
Neuromuscular Stimulation (STIM) and EMG Triggered
Stimulation (ETS) should not be used by Patients tted with
demand style cardiac pacemakers. Please seek advice from
your health supervisor.
Patient’s shock protection type: BF (Body Floated) Equip-
ment. This equipment is not earthed but contains a battery
within an insulated unit.
Indicates the manufacturer’s catalogue number so that the
medical device can be identied.
Manufacturer's LOT/Batch number. Present it together
with SN number when you report a technical fault or
claim a warranty return.
Manufacturer's serial number of the unit. Present it
together with LOT number when you report a technical
fault or claim a 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 - Notied body identication (LRQA Ltd.)
This product should be kept dry.
IP20
on the unit
This is an indication for protection against ingress of water
and particulate matter. The mark IP20 on your unit means:
your unit is protected against solid foreign objects of 12.5mm
dia and greater. Not 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 14 for the disposal instructions).
REF

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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 mains power supply.
* Do not immerse unit into water or any other substance.
* The unit is not protected from the ingress of shower of rain if used outside
the carrying case.
* Do not use the NeuroTrac® Continence unit in the presence of a
ammable anaesthetic gas mixture.
* Please use 9 Volt alkaline battery (IEC code: 6LR61, size: PP3). If using
rechargeable 9 Volt battery, be sure to use Nickel Metal Hydride type
batteries (IEC Code 6HR61).
We advise not to use Ni-Cad rechargeable batteries.
Caution: Do not use lithium batteries unless they comply with
IEC60086-4.
* Patient Electrodes are for single patient use only.
* Keep out of reach of children.
* Do not use this stimulator on your facial area unless you are under strict
guidance from a qualied Clinician.
* Application of electrodes near the thorax may increase the risk of cardiac
brillation.
* Operation in close proximity to shortwave or microwave therapy
equipment may produce instability in the stimulator output.
* Simultaneous connection of a patient to high frequency surgical equipment
may result in burns at the site of the stimulator electrodes and possible
damage to the stimulator.
* This device can deliver current densities in excess of 2mA/cm2 when used
at a high intensity with small electrodes.
* No modication of this equipment is allowed.
Warnings

NeuroTrac® Continence Operation Manual
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Contents Page
Unit symbols explanation 2
Warnings 3
What is STIM? 5
Contraindications & precautions 6
Description of STIM unit & functions 7
Quick start instructions 8-9
Lock button 10
Setting up customised programmes 10
Continence treatment programmes 12
Electrode types & tips 13
Care, maintenance, accessories and disposal 14
Indications for use 15
Technical specications 16
Troubleshooting 17
Warranty 18
Clinical references 19
Contents

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Neuromuscular Stimulation has been used for many years to stimulate muscle
and nerve bres to treat a number of muscle and nerve related conditions.
Over the last 30 years numerous clinical trials and papers have been written.
The NeuroTrac®Continence is one of a new breed of modern neuromuscular
stimulators which Verity Medical have developed with the therapist and patient
in mind. Our principle aim is to design products that have high levels of
functional use, are sensibly priced, compact and user friendly.
The NeuroTrac®Continence is a dual channel device combining several
treatment programmes into one unit. Neuromuscular stimulation is increasingly
understood by therapists and doctors. There is a better understanding of the
mechanisms which exist between nerves and muscles that makes it possible
to stimulate the neuromuscular system with precise electrical signals. The
NeuroTrac®Continence offers precision giving full control of pulse widths,
rates, ramp up times, work / rest cycles as well as alternating or synchronous
application if two channels are being applied.
Customer Care
We welcome constructive comments regarding our equipment, particularly
those that might help us to improve existing features, add new ones or develop
new products for the future.
What is STIM?

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Before using this equipment you must rst seek the advice of your
physiotherapist or doctor.
Read this operating manual before using the STIM unit.
STIM should not be used:
* By patients tted with a demand style cardiac pacemakers unless so
advised by their doctor.
* During pregnancy [unless medically advised].
* By patients with undiagnosed pain conditions.
* By patients with undiagnosed skin, vaginal or rectal conditions.
* With patients who have diminished mental capacity or physical competence
who cannot handle the device properly.
* On anaesthetised or desensitised skin.
* When driving a vehicle or operating potentially dangerous equipment.
* Do not place electrodes:
> Over carotid sinus nerves.
> Over larynx or trachea.
> Inside mouth.
> Over the area of the heart unless so advised by your doctor.
> On your facial area unless under strict guidance from a qualied clinician.
> Do not apply stimulation across or through the head, directly on the eyes,
covering the mouth, on the front of the neck (especially the carotid sinus) or
via electrodes placed on the chest and upper back or crossing over the heart.
* The patient should use the unit only as prescribed.
* Do not immerse the unit in water or any other liquid.
* Keep unit out of reach of children.
* If in doubt about the use of the STIM unit, call your doctor, therapist,
clinician or your distributor for advice.
* Only use CE approved skin electrodes.
* Only use CE approved vaginal or rectal probes.
Contraindications & Precautions

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* PRG button Selects the desired set programme from P01 - P09 or
customised programme PC1 - PC4.
* SET button This button works only for programmes PC1-PC3. Press
and hold SET button for 3 seconds to set parameters of
your custom treatment: Pulse Rate, Pulse Width, Time, etc.
* ESC button Stores customised programme and returns to the
home position.
LCD
Display
Channel A Channel B
SET to go
to custom
programme
settings
ESC to stop
programme
or escape
from settings
+to start
programme
Select
Programme Lock
Button
Lead
Wire
and Pin
Front Back
Concealed button locks the selected
programme and records the pa-
tient’s home compliance.
Use a metal pin of the lead wire to
press the concealed button located
in the battery compartment.
Description of STIM Unit & Functions
Connect the
optional probe to
channel A or B.

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1. Remove battery cover. Insert 9 Volt alkaline (IEC code: 6LR61)
or rechargeable Ni-MH battery (IEC code 6HR61) into the battery
compartment. Replace the cover.
2. Insert the lead wire(s) into the sockets of the unit. Either red or black or red
cable can be inserted. You may use one lead or both leads. If you are only
using one lead wire (for Channel A), insert the lead wire into the right hand
socket (Channel A).
3. Remove the vaginal or rectal electrode from its packaging.
4. Connect the vaginal or rectal electrode to each of the pin connectors at the
end of the lead wire. It does not matter which way the red/black cables are
connected. Some probes have a long wire built-in, with the direct plug to
the unit.
5. Make sure the vaginal or rectal electrode is clean before use.
6. Insert the vaginal or rectal electrode using any electrically-conductive
lubricating gel or any other water-based lubricating gel (recommended for
maximum performance).
A typical vaginal electrode placement diagram:
Quick Start Instructions
P
E
L
V
I
C
F
L
O
O
R
uterus
rectum
vaginal electrode
Do not insert the probe too deeply, the neck of the probe should be just
inside the vagina, the metal plates of the probe should be fully inserted,
metal plates facing hips.
your body
outline
neck of
the probe
Metal plates of the vaginal
probe which makes an
electrical connection with
your body

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7. Turn on the unit by pressing the on/off button once.
8. Select the desired programme by pressing the PRG button (please refer to
the programme tables on page 12).
9. Hold down the A+ button until you feel a strong but comfortable current.
The current may be decreased by pressing the A- button.
10. You may adjust the strength of the current during the treatment by pressing
the A+ or A- buttons.
11. To exit the programme before it is nished, turn off the unit by pressing the
on/off button once.
12. Important: Do not remove your probe / electrodes while the unit is running.
13. Carefully clean vaginal or rectal electrode before and after use. Wash
the probe gently in mild soapy water, rinse and make sure the probe is
completely dry before returning to storage in the plastic bag.
Low Battery Indicator
When the battery power is low, the low battery indicator will appear on the
screen (shown in the diagram on page 7). When the battery indicator shows one
bar, replace the battery.
Disconnection Indicator
When the probe becomes disconnected or when the lead wires do not conduct
the electrical current, the milliamp level will return to zero and the effected
channel will ash on and off.
Common Issue:
If you press + button but the intensity stops at 6-9 mA and cuts off to zero
and you see 0 mA ashing on the screen:
- This is a typical situation for any muscle stimulator. You are experiencing
the safety cut off due to no electrical load on the output. You should be able
to resolve this issue yourself, please follow the troubleshooting chapter on
page 21.

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Lock Button
A "concealed" lock button is included in the NeuroTrac®Continence which
allows the clinician to accurately monitor "home compliance" of the patient
between appointments. It also locks the customised or built in programmes.
To lock the unit
1. Select the built in or customised programme required. In the case of a
customised programme, make sure that the pulse width, frequency, time
etc. are set-up correctly.
2. Remove the battery cover and, using a thin rod (end of the lead wire pin
meets this requirement) gently press on the lock button as shown in the
diagram on page 7 until you hear a double beep. The unit is now "locked"
and cannot be altered until "unlocked".
To unlock the unit
Remove the battery cover and press the concealed switch with a thin rod
(end of the lead wire pin meets this requirement) until a single beep is heard.
Now the LCD will display the average mA used on each channel and the total
hours the unit has been in use as shown in the diagram. To return to normal
"unlocked" operation, simply press ESC.
Setting up the Customised Programme PC4 (Continuous)
Select PC4 by pressing the PRG button on the front panel.
1. Press and hold the SET button for 3 seconds until Hz symbol will ash
on the display, then press the + or – button to adjust the pulse rate from
2-100Hz.
2. Press the SET button again and the µs symbol will ash on/off, then
press the + or – button to adjust the pulse duration from 50 - 450µs.
3. Press the SET button again and the Clock [Time] symbol will ash on/
off, then press the Channel A +/- button to alter the hours and Channel B
+/- button to adjust minutes.[Maximum time 12 hours 59 minutes].
45 Number of hours the device
was used when it was locked.
20mA 20mA
Ch.A Ch.B
Average Intensity used on channel A and B