OML Microstim2 User manual

…a confident choice
The output of this device has a physiological e󰀨ect.
The device should only be supplied and set-up by a trained clinician.
Read the instructions and precautions before use.
INSTRUCTION MANUAL
Microstim2

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Contents
Introduction
Kit Content 4
Introduction 5
Intended use 5
Important Information
Contraindications 6
Warnings 6-8
Precautions 9-12
Symbols and Denitions 13-14
Operating Guide
Key Features 15-17
Stimulation Modes 18-21
Electrodes 22-24
Technical
Technical 25-28
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Microstim2 Kit Contents
Description Product Code Qty
Microstim 2V2 01-001-0015 1
Electrode Lead 1m 03-001-0008 2
Electrodes, Grey, 30x50mm 01-004-008 1 pack of 4 electrodes
Battery,PP3, 9V 05-001-0002 1
Instruction manual 11-003-0008 1
Warranty Card 11-003-0067 1
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Introduction
Intended Use Statement
The Microstim2 is intended to be used for the alleviation of disability related to
muscular weakness or inactivity. The weakness may be due to an upper motor
neurone lesion or disuse atrophy.
The Microstim2 can be used to strengthen muscles, reduce spasticity, increase
range of movement, reduce pain, reduce oedema and increase local blood ow.
Stimulation can also modulate the central nervous system promoting neuroplasticity.
The Microstim2 is designed for use in home healthcare, residential and hospital or
healthcare environments.
General Description
The Microstim2 neuromuscular stimulator is intended for the exercise of weak or
paralysed muscle. It is designed to be simple to use with the minimum necessary
user controls. The output stimulation intensity is ramped at the beginning and
end of each cycle by pulse width modulation to produce a comfortable sensation.
Powered by a standard 9V battery, this makes it ideal for use at home for regular
exercise.
Warranty
The Microstim2 is warrantied for a period of two years from the date of sale or
tting. Should any failure of the device occur during the warranty period, the device
should be returned to Odstock Medical Limited for inspection. Should the failure be
due to manufacturing or material defect the device will be repaired or a replacement
supplied free of charge.
The warranty is valid providing that the failure cannot be attributed to misuse and
the warranty registration card has been completed and returned to Odstock Medical
Limited as soon as possible. Alternatively, this information can be completed online
at: www.odstockmedical.com
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Important Information (Warnings)
Important Information
The clinician shall brief the patient on any known contraindications and warnings
to the use of this system and any precautions to be taken. The clinician shall issue
and guide the patient through the user instruction manual.
Contraindications
The Microstim2 should not be used on people who have a cardiac pacemaker,
implanted debrillator, or other electronic implanted device unless investigations
demonstrate that there is no interaction between the devices.
Neck Stimulation
Stimulation should not be applied over the neck, because severe spasm of the
muscles may occur and the contractions may be strong enough to close the airway
or cause di󰀩culty in breathing. Stimulation over the neck (especially carotid sinus)
could have adverse e󰀨ects on heart rhythm or blood pressure.
Open or Infected Wounds
Stimulation should not be applied over open wounds or over swollen, infected,
or inamed areas or skin eruptions. Stimulation should only be applied to normal
intact, clean skin. Dilated capillaries and movement caused by moving muscles
may disrupt healing tissue.
Cancer
Stimulation should not be applied over, or in proximity to, cancerous tissues as
increased local blood ow may increase tumour growth.
Electronic Monitoring Equipment
Stimulation should not be applied in the presence of electronic monitoring
equipment, such as cardiac monitors and electrocardiogram alarms. Monitoring
equipment may not operate properly when the electrical stimulation device is in
use.
Transcerebral Stimulation
The e󰀨ects of stimulation of the brain are unknown. Therefore, stimulation should
not be applied across the head and electrodes should not be placed on opposite
sides of the head, directly on the eyes or covering the mouth.
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Important Information (Warnings)
Strangulation
There is a risk of strangulation with wires of the system. Do not place leads around
the neck. Use an appropriate length of lead.
Chest Stimulation
Stimulation should not be applied between the chest and upper back, crossing over
the heart, because the introduction of electrical current into the chest may cause
rhythm disturbances to the patient’s heart, which could be fatal.
Epilepsy
People with suspected or diagnosed epilepsy should follow precautions
recommended by their physicians. The Microstim2 should not be used by people
who have poorly controlled epilepsy. Odstock Medical Limited recommend that an
intended device user is t free for 3 months before commencing treatment.
Sleeping
Do not use the stimulator whilst sleeping.
Batteries
Only use batteries recommended by Odstock Medical Limited.
Ensure you follow the instructions for installing, using, storing and disposing of the
battery.
Do not short circuit the battery. Doing so may lead to excessive heat and possible
burns.
When transporting batteries, cover the terminals with tape or other non-conductive
material to prevent the terminals from shorting.
Flammable Cleaning Products
Do not use ammable cleaning products to clean the device.
High Frequency Surgical Equipment
Simultaneous connection to high frequency surgical equipment may result in burns
at the site of the stimulator electrodes and possible damage to the stimulator.
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Important Information (Warnings)
Oxygen Rich Environments
Do not use stimulation within oxygen rich environments such as a hyperbaric
oxygen chamber or in close proximity to an oxygen mask.
External Orthopaedic Metal Fixation
Stimulation should not be applied in the area of exposed orthopaedic metal work.
Flammability
Do not use the stimulator near ammable fuels, fumes or chemicals.
Electromagnetic Emissions
Use of accessories and cables other than those specied or provided by Odstock
Medical Limited could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally.
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Important Information (Precautions)
Degradation of Stimulator, Consumables and Accessories
Do not use the device if the stimulator, cables or electrodes are damaged in any
way. Replace the cables if they become sti󰀨 or have cracked insulation.
Handling Electrodes
Do not handle electrodes while the stimulation is on. Always make sure that the
Microstim2 is turned o󰀨 before adjusting the electrodes. Only apply electrodes as
described in this instruction manual.
Exposed Electrode Pins
Ensure that the pins of the electrode wire are fully inserted into each electrode
before use.
Skin Irritation
Some people may experience skin irritation due to electrical stimulation or the
electrodes. The irritation can usually be reduced by using an alternative type of
electrode, di󰀨erent device settings or a new electrode position. A slight reddening
of the skin under the electrodes is normal and this should clear within 1 hour of
stopping stimulation. If stimulation causes long term marking of the skin, the patient
should discontinue use and contact their clinician.
Skin Care
Do not shave the skin under the electrodes. If long hairs require removal, cut the
hairs using scissors. If skin moisturisers are required, use overnight and remove
residue using warm water with a mild soap before applying electrodes in the
morning.
Prevention of Pressure Sores.
Patients should check the integrity of their skin that is in contact with the electrodes,
lead, or stimulator each time the device is used. If pressure marking occurs, remove
the cause of the pressure and recommence use once the skin marking has cleared
Spasticity
If stimulation causes increased spasticity (involuntary, exaggerated muscle sti󰀨ness
and spasms), the patient should discontinue use and consult their clinician.
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Important Information (Precautions)
Machinery Operation and Driving
Stimulation should not be used when driving, operating machinery, or during any
activity in which electrical stimulation could distract or put the patient at risk of
injury.
Bathing, Showering or Swimming
Do not use stimulation in the bath, shower or when swimming.
Water Ingress
Do not get the stimulator, or any part of the system or accessories wet. Water
ingress may stop the stimulator or accessories working. If submerged, remove
battery (if present), dry out thoroughly and return to Odstock Medical Limited for
assessment. If liquid is split on the stimulator, remove battery and dry out thoroughly
prior to re-use.
Shortwave and Microwave Therapy
Do not use in close proximity (e.g. 1m) to a shortwave or microwave therapy
medical equipment as it may produce instability in the stimulator output.
Autonomic Dysreexia
Patients who have high level spinal cord injuries (T6 and above), may experience
symptoms of autonomic dysreexia (increased blood pressure or sweating in
response to stimulation). This may also be seen in patients with multiple sclerosis.
If a󰀨ected, the patient should discontinue use and consult their physician.
Cardiac/Exercise Stress
Patients with suspected or diagnosed heart disease should follow the exercise
precautions recommended by their physician.
Deep vein thrombosis
Patients with suspected or diagnosed deep vein thrombosis should follow the
exercise precautions recommended by their physician.
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Important Information (Precautions)
Injury, Fracture or Surgery
Electrical stimulation should not be carried out in areas of the body a󰀨ected by
recent injury, fracture or surgery. Movement caused by moving muscles may
disrupt healing.
Pregnancy
The safety of using electrical stimulation during pregnancy has not been established.
Prescribed User
The device should only be used by the patient that the system has been prescribed
for. Keep out of reach of non-intended users. Only use as instructed by the clinician.
Long-term E󰀨ects
The long-term e󰀨ects of electrical stimulation are unknown. Odstock devices have
been successfully used by individuals for over 20 years.
Accessories and Consumables
Only use accessories and consumables recommended by Odstock Medical
Limited. Do not connect with equipment other than that intended to be used with
this system as dened within this instruction manual or that of the other equipment.
Battery Change and Battery Cover
Do not operate the stimulator with the battery cover removed. Disconnect all the
leads prior to opening the battery cover. The clinician / carer should not be in
contact with the patient when changing the battery.
Equipment Modication
Do not tamper with, or modify the equipment.
Shelf Life
Do not use the consumables if they have passed their expiry date.
Equipment Re-use
Electrodes are single patient use only. If re-using other parts of the system ensure
a thorough clean using anti-bacterial wipes.
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Important Information (Precautions)
Storage Temperature
Do not store outside of the temperature limits as detailed in the specication on
page 27 If the Microstim2 or accessories (excluding electrodes) have been stored
at the minimum (-20°C) or maximum (70°C) storage temperatures, allow at least 10
minutes in ambient temperature before use.
Use of Small Electrodes
The use of small electrodes (less than 32mm diameter) may result in higher charge
density especially when using high output settings (current, frequency) and may
lead to an increase in the likelihood of skin irritation. When possible use larger
electrodes. Always monitor skin condition closely.
Adverse Reactions
The patient should report any undesirable outcomes, malfunctioning of the device,
mistakes in using the device, or injury from the use of this device to the clinician
who provided it to them.
The clinician is responsible for reporting all adverse events to Odstock Medical
Limited or their local representative.
Residual Risk
Even though Odstock Medical Limited have taken all foreseeable steps, through
design and testing, to ensure this device is safe and reliable, there remains a small
risk of stimulation not being delivered when required.
Safe Disposal of Equipment
Care should be taken to dispose of parts and accessories of the device in the correct
manner. In order to protect the environment, the product and its accessories should
not be disposed of in household waste. Please dispose of as per local regulations.
Alternatively, equipment can be returned to Odstock Medical Limited for disposal
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Symbol Denitions
Attention: device has a physiological e󰀨ect
Caution (used throughout the instruction manual to identify
caution item).
Applied parts of insulation type BF.
Read the instructions and precautions before use.
This product should not be disposed of with other household waste.
Your Microstim2 and accessories can be returned to Odstock
Medical Limited for appropriate disposal.
The CE mark indicates that the Microstim2 complies with the
European Union Medical Device Directive.
Date of manufacture.
Do not get any part of the system wet.
Expiry date (Year, Month, Day) of product (may relate to
specic components, such as electrodes and batteries inside
the packaging).
Manufactured by Odstock Medical Limited
Odstock Medical Limited
National Clinical FES Centre
Salisbury District Hospital
Salisbury, Wiltshire, UK
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Symbol Denitions
Do not use if the packaging is substantially damaged. Proceed
with caution and check components for damage prior to use.
Do not store outside of specied temperature limits. If
accompanied by <mo; for storage less than 1 month. If >mo; for
storage greater than 1 month.
Do not store outside of the specied relative humidity limits.
Do not store outside of the specied atmospheric pressure limits
LOT
Batch number.
SN
Unique serial number of the stimulator.
REF
Odstock Medical Limited stimulator reference number
EC REP
European authorised representative.
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Key Features
Front Cover:
Underneath View Showing Battery Location and Electrode
Sockets:
A
0
/
I
1
2
3
456
7
8
9
B
Mode
+
-
Power On
indicator
(flashes)
Mode change switch
and display
Output indicator
for channel A
Output indicator
for channel B
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0
/
I
1
2
3
456
7
8
9
On/Off Click
position
PP3
Battery
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Key Features
Controls & Indicators
The stimulation output level controls
are the rotary knobs. To switch ON
the stimulator, rotate either of the
level controls clockwise from the ‘I/0’
position until a click is heard. The
stimulator should emit a short bleep
and the green power indicator will
begin ashing and continue ashing
while the stimulator remains on.
After the initial long beep a sequence
of quick beeps will signal the number
of the mode selected. Note that
mode 0 means there will be zero short
beeps! Further clockwise rotation
of the level controls increases the
stimulation intensity. To switch OFF
the stimulator, rotate both level
controls fully anti-clockwise until a
click is heard and the power indicator
is extinguished.
The presence of a stimulation voltage
at either of the output connectors is
shown by the corresponding yellow
output indicator. The ‘A’ output is on
the left of the box and the ‘B’ output
is on the right.
The mode select control is the central
pushbutton switch. A number is
displayed which indicates the mode
selected. To increase the mode the lower switch is pressed and to decrease the
upper switch is pressed. The mode control permits selection of the appropriate
stimulation frequency and pattern for the chosen exercise.
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Key Features
Connectors
Two stimulation output connectors are provided. One is located in each side of the
case. The stimulation lead connectors should be inserted here ensuring positive
engagement in the sockets. When disconnecting the leads, remove the plugs by
holding the plastic body - do not pull the wires.
Battery
A 9V PP3 alkaline non-rechargeable battery or equivalent rechargeable battery
can be used. Ensure that the battery is correctly inserted. Remove the battery
from the stimulator if it is not intended to be used for an extended period.
Low Battery
When the battery nears exhaustion a low battery warning will occur. During an
exercise period the stimulator will automatically reduce the stimulation output to
zero and then bleep and ash the power indicator for approximately thirty seconds.
After this time the stimulator will enter ‘sleep’ mode and should be switched OFF
before replacing the battery. The ‘low battery’ warning has been set to provide
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Stimulation Modes
Stimulation Modes
Eight modes (0-7) are provided for general exercise with modes 8 & 9 provided
for more specialised exercise. The stimulation formats are summarised in the
following table and explained fully below.
A continuous mode is useful when nding the correct electrode sites.
Changing Modes
While the stimulator is operating, the mode switch can be used to change to a
stimulation mode which has the same stimulation frequency. For example, while
exercising on mode 3 the user may only select modes 2 or 4. After a short delay
Mode Frequency Format Possible Use
040Hz ALTERNATE
Slow ramp (6s)
• Exercise modes for possible improvement
in muscle fatigue resistance etc.
• A slow ramp is used when there is a high
level of spasticity
1 40Hz SIMULTANEOUS
Slow ramp (6s
2 20Hz CONTINUOUS • Setting up electrode positions and
stimulation levels
3 20Hz ALTERNATE • Normal quadriceps exercise mode
4 20Hz SIMULTANEOUS • For simultaneous contraction of 2 sets of
muscles e.g. hand stimulation
5 40Hz CONTINUOUS • Setting up electrode positions and
stimulation levels or when using a probe
6 40Hz ALTERNATE • Normal common-peroneal exercise mode
7 40Hz SIMULTANEOUS • For simultaneous contraction of 2 sets of
muscles
8 40Hz OVERLAPPING • Shoulder subluxation
9 20Hz OVERLAPPING • Shoulder subluxation – reduced fatigue
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Stimulation Modes
the stimulation intensity will decrease to zero and a bleep will inform the user that
the mode has changed. The intensity will then increase to the previously set level
and exercise will continue in the new mode. If a mode with a di󰀨erent stimulation
frequency is required, it is necessary to switch OFF the stimulator, select the
new mode and then switch ON the stimulator. This is a safety feature to avoid
unexpectedly high stimulation levels.`
Stimulation Formats
The formats continuous, alternate, simultaneous and overlapping describe the
manner in which the intensity of the stimulation output of channels A & B change
relative to each other.
Continuous
The intensity of both outputs gradually increases from zero to the maximum set
by each channel level control and remains at this level until another mode is
selected or the stimulator is switched o󰀨. This format is normally used before an
exercise period to allow location of optimum electrodes positions and comfortable
stimulation levels.
Muscle Recruitment
Channel A
Channel B
Time
2 second
ramp up
level until switch off or mode change
Switch on
Beeps finish
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Stimulation Modes
Alternate
The intensity of each output gradually increases from zero to the maximum set
by the channel level control, remains at this level for a set time and gradually
decreases from this level back to zero. After a set time this cycle is repeated. Only
one of the two outputs is on at any time. This format is the normal exercise mode
for independent muscle groups such as the quadriceps or agonist / antagonist
muscle pairs.
Simultaneous
The intensity of both outputs gradually increases from zero to the maximum set
by each channel level control, remain at this level for a set time and gradually
Muscle Recruitment
Channel A Channel A
Channel A
Channel BChannel B Channel B
Time
2 second
ramp up
2 second
ramp down
2 second
wait between
stimulation
10 second
level
Switch on
Beeps finish
Muscle Recruitment
Channel A Channel A
Channel B Channel B
Time
2 second
ramp up
2 second
ramp down
10 second
level
Switch on
Beeps finish
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