Table of Contents
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Summary of Contents for OML Microstim2
- Page 1 INSTRUCTION MANUAL Microstim2 The output of this device has a physiological effect. Read the instructions and precautions before use. The device should only be supplied and set-up by a trained clinician. …a confident choice...
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Page 3: Table Of Contents
Contents Introduction Kit Content Introduction Intended use Important Information Contraindications Warnings Precautions 9-12 Symbols and Definitions 13-14 Operating Guide Key Features 15-17 Stimulation Modes 18-21 Electrodes 22-24 Technical Technical 25-28... - Page 4 Microstim2 Kit Contents Description Product Code Microstim 2V2 01-001-0015 Electrode Lead 1m 03-001-0008 Electrodes, Grey, 30x50mm 01-004-008 1 pack of 4 electrodes Battery,PP3, 9V 05-001-0002 Instruction manual 11-003-0008 Warranty Card 11-003-0067...
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Page 5: Introduction
Warranty The Microstim2 is warrantied for a period of two years from the date of sale or fitting. 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. -
Page 6: Important Information
Contraindications The Microstim2 should not be used on people who have a cardiac pacemaker, implanted defibrillator, or other electronic implanted device unless investigations demonstrate that there is no interaction between the devices. -
Page 7: Warnings
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 fit free for 3 months before commencing treatment. - Page 8 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 flammable fuels, fumes or chemicals.
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Page 9: Precautions
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. 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. - Page 10 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 11 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 12 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.
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Page 13: Symbols And Definitions
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. - Page 14 Symbol Definitions 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 specified temperature limits. If accompanied by <mo; for storage less than 1 month. If >mo; for storage greater than 1 month.
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Page 15: 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 A for channel B Underneath View Showing Battery Location and Electrode Sockets:... - Page 16 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 17 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.
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Page 18: 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 19 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 different stimulation frequency is required, it is necessary to switch OFF the stimulator, select the new mode and then switch ON the stimulator.
- Page 20 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 21 Stimulation Modes decrease to zero. After a set time this cycle is repeated. Both outputs are active 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.
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Page 22: 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 23 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 24 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.
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Page 25: Technical
Technical 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 26 Stimulation pulse width: 330µs maximum . The Microstim2 is a Class IIa Medical Device within the definition of the European Medical Devices Directive. Expected Service Life and Shelf life This is an indication of the life span of the parts (figures based upon daily use). Life span will depend on usage.
- Page 27 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 28 Whilst we may not be able to change products that are in production we welcome ideas that we can incorporate into future developments. Special Requirements The Microstim2 may be supplied with different parameters if required. Please address any such requests to sales@odstockmedical.com...
- Page 29 Notes...
- Page 30 Notes...
- 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 2008 - 2021 Revision: 13.00 Manual Product Code: 11-003-0008 QF/018 2797...