OML Microstim2 Manuale utente
…a confident choice
The output of this device has a physiological eect.
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 Denitions 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 debrillator, 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 diculty in breathing. Stimulation over the neck (especially carotid sinus)
could have adverse eects on heart rhythm or blood pressure.
Open or Infected Wounds
Stimulation should not be applied over open wounds or over swollen, infected,
or inamed 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 eects 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 specied 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, dierent 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 stiness
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 Dysreexia
Patients who have high level spinal cord injuries (T6 and above), may experience
symptoms of autonomic dysreexia (increased blood pressure or sweating in
response to stimulation). This may also be seen in patients with multiple sclerosis.
If aected, 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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