OML Microstim2V2 Instruction Manual

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Download this manual

INSTRUCTION MANUAL

Microstim2V2

The output of this device has a physiological effect.

Read the instructions and precautions before use.

The device must be set up by a person who has been trained in the

use of FES

...a confident choice

Table of Contents

Need help?

Do you have a question about the Microstim2V2 and is the answer not in the manual?

Questions and answers

Summary of Contents for OML Microstim2V2

Page 1 INSTRUCTION MANUAL Microstim2V2 The output of this device has a physiological effect. Read the instructions and precautions before use. The device must be set up by a person who has been trained in the use of FES …a confident choice...
Page 3: Table Of Contents
Contents Introduction Kit Content Intended use Introduction Important Information Contraindications Warnings Precautions 10-13 Symbols and Definitions 14-16 Operating Guide Key Features 17-19 Stimulation Modes 20-24 Electrodes 25-27 Technical Technical 28-31...
Page 4 Microstim2 Kit Contents Description Product Code Microstim 2V2 01-001-0015 Electrode Lead 1m 03-001-0008 Electrodes, Grey, 33x53mm 01-004-0007* 1 pack of 4 electrodes Battery,PP3, 9V 05-001-0002 Instruction manual 11-003-0008 Warranty Card 11-003-0067 * This item has an expiry date. Please refer to its packaging for more detail.
Page 5: Intended Use
Intended Use 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 flow.
Page 6: Introduction
Introduction 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.
Page 7: Important Information
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 defibrillator, or other electronic implanted device unless investigations...
Page 8: Warnings
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.
Page 9: Electromagnetic Emissions
Important Information (Warnings) External Orthopaedic Metal Fixation Stimulation should not be applied in the area of exposed orthopaedic metal work. Flammability Do not use the stimulator near flammable fuels, fumes or chemicals. Electromagnetic Emissions Use of accessories and cables other than those specified or provided by Odstock Medical Limited could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Page 10: Precautions
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 stiff or have cracked insulation. Handling Electrodes Do not handle electrodes while the stimulation is on. Always make sure that the Microstim2 is turned off before adjusting the electrodes.
Page 11 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.
Page 12: Equipment Modification
Important Information (Precautions) Injury, Fracture or Surgery Electrical stimulation should not be carried out in areas of the body affected 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.
Page 13 Important Information (Precautions) Storage Temperature Do not store outside of the temperature limits as detailed in the specification 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.
Page 14: Symbol Definitions
Symbol Definitions Attention: device has a physiological effect Caution (used throughout the instruction manual to identify caution item). Applied parts of insulation type BF. Read the instructions and precautions before use. Read Instructon for use The CE mark indicates that the Microstim2 complies with the European Union Medical Device Directive.
Page 15 Symbol Definitions Do not store outside of specified 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 specified relative humidity limits. Do not store outside of the specified atmospheric pressure limits Batch number.
Page 16 Symbol Definitions Distributor 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.
Page 17: Key Features
Key Features Front Cover: Mode change switch Power On and display indicator (flashes) 0 / I 0 / I Mode On/Off Click position Output indicator Output indicator for channel B for channel A Underneath View Showing Battery Location and Electrode Sockets:...
Page 18: Controls And Indicators
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 flashing and continue flashing while the stimulator remains on.
Page 19: Output Connectors
Key Features Output 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.
Page 20: Stimulation Modes
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 finding the correct electrode sites. Mode Frequency Format Possible Use...
Page 21 Stimulation Modes exercising on mode 3 the user may only select modes 2 or 4. After a short delay 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.
Page 22 Stimulation Modes Alternate 10 second level Channel A Channel A 2 second 2 second ramp up ramp down Channel B Channel B Time 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.
Page 23 Stimulation Modes simultaneously, with stimulation intensity changes in phase. This format is the normal exercise mode for related muscle groups requiring stimulation at the same time e.g. Elbow and finger extensors. Overlapping 10 second level Channel A Channel A Channel A 2 second 2 second ramp up...
Page 24: Electrodes
Electrodes Electrodes Two types of electrodes are available; • self-adhesive electrodes. • conductive silicone rubber electrodes used with adhesive gel. The therapist will explain which type you have and how to use them. Self-Adhesive Electrodes Connect the electrodes to the leads by inserting the pin into the connector on the flying leads of the electrodes.
Page 25: Electrodes Placement
Electrodes adhesion to the skin. Place the electrodes on the skin in the desired positions. The electrode with the black plug is the active electrode. The electrode with the red plug is the indifferent electrode Adhesive tape will be required to hold the electrodes in place.
Page 26 Electrodes stimulating for hand opening, place the indifferent over the thumb and index finger motor points (centre of the forearm about 3 finger breadths above the wrist) and active electrode over the wrist and finger extensors (posterior interosseous nerve – about 3 finger breadths proximal from the indifferent electrode) will give strong finger and wrist extension but less thumb extension.
Page 27: Fault Finding
Electrodes Fault Finding To assist you with solving any problems you may have with your stimulator, we have included a list of possible problems with likely solutions; No output and no indicator lights: Exhausted battery - replace battery. Battery incorrectly installed - reconnect battery. Faulty stimulator - return to Odstock Medical.
Page 28: Technical
Technical Excessively high stimulation intensity - adjust appropriate level control. The stimulator bleeps for 30 seconds then switches off: Low battery - replace battery if a non-rechargeable PP3 is used, recharge battery if a rechargeable battery is used. Specifications Output amplitude: Maximum 100mA with 1KOhm output load.
Page 29 Technical Medical Device Class IIa, internally powered, continuous operation. Type BF Classification: applied part(s) No protection against liquid ingress. Do not get the device wet! Ingress Protected against objects entering the stimulator of 12.5mm and protection rating above. Operational Storage & Transport Electrodes: 5°C to 27°C >1 month Electrodes: 5°C to 27°C...
Page 30: Special Requirements
Technical Feedback We are looking to improve our products and make them more suitable for the needs of patients and therapists. Please contact us with your ideas for improvements. Whilst we may not be able to change products that are in production we welcome ideas that we can incorporate into future developments.
Page 31 Notes...
Page 32 Odstock Medical Limited +44 (0) 1722 439540 The National Clinical FES Centre Salisbury District Hospital, www.odstockmedical.com Salisbury, Wiltshire SP2 8BJ United Kingdom enquiries@odstockmedical.com Registered Company No. 5532620 © Copyright Odstock Medical Limited 2025 Revision: 16.00 Manual Product Code: 01-003-0008 2797...