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Technical

Medical Device

Classification:

Class IIa, internally powered, continuous operation. Type BF
applied part(s)

Ingress
protection rating

No protection against liquid ingress. Do not get the device wet!
Protected against objects entering the stimulator of 12.5mm and
above.

Operational

Storage & Transport

Temperature:

Electrodes:

5°C to 27°C

Alkaline Battery:

-20

°C to 54°C

System (excluding above

items):

°C to 40°C

Electrodes:

5°C to 27°C >1

month

Electrodes:

0°C to 40°C <1

month

Alkaline Battery:

5°C to 30°C

System (excluding above
items):

-20°C to 70°C

Relative

humidity:

Electrodes: 35% to 50%

System & Batteries: 15% to 90%

Electrodes: 35% to 50%

System & Batteries: 15% to 90%

Atmospheric

pressure:

700hPa to 1060hPa

Stimulator size:

125 x 70 x 26 mm

Battery:

PP3, 9V

Battery life of

average use:

Alkaline battery: 6 to 12 weeks

Stimulator

weight:

165g with battery

Содержание Microstim2

Страница 1: ...ent choice The output of this device has a physiological effect The device should only be supplied and set up by a trained clinician Read the instructions and precautions before use INSTRUCTION MANUAL Microstim2 ...

Страница 2: ...2 ...

Страница 3: ...ntroduction 5 Intended use 5 Important Information Contraindications 6 Warnings 6 8 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 1 2 3 4 ...

Страница 4: ...iption 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 1 ...

Страница 5: ...e 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 fitting Should any failure of the d...

Страница 6: ...verse effects on heart rhythm or blood pressure Open or Infected Wounds Stimulation should not be applied over open wounds or over swollen infected or inflamed 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 can...

Страница 7: ...Medical Limited recommend that an intended device user is fit 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 possibl...

Страница 8: ...ammable 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 Use of this equipment adjacent to or stacked with other equipment should be avoided because it could res...

Страница 9: ... 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 moist...

Страница 10: ...d 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 Dysreflexia Patients who have high level spinal cord injuries T6 and above may experience symptoms of autonomic dysreflexia increased blood pressure or sweating in response to...

Страница 11: ... 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 defined 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 Disconn...

Страница 12: ...hould 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 test...

Страница 13: ... 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 specific components such as electrodes and batteries inside the packaging Manufactured by Odstock Medical Lim...

Страница 14: ...e 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 LOT Batch number SN Unique serial number of the stimulator REF Odstock Medical Limited stimulator reference number EC REP European authorised representative 2 ...

Страница 15: ...g Battery Location and Electrode Sockets A 0 I 1 2 3 4 5 6 7 8 9 B Mode Power On indicator flashes Mode change switch and display Output indicator for channel A Output indicator for channel B 3 0 I 1 2 3 4 5 6 7 8 9 On Off Click position PP 3 Battery 3 ...

Страница 16: ...se 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 t...

Страница 17: ...hat 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 flash the power indicator for approximately thirty seconds After this t...

Страница 18: ...Frequency Format Possible Use 0 40Hz 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 ...

Страница 19: ...mulation 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...

Страница 20: ...cle 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 B Channel B Channel B Time 2 second ramp up 2 second ramp down 2 second wait between stimulation 10 se...

Страница 21: ...mum channel B ramps down Channel A then continues and B will ramp up again and the sequence repeats Overlapping mode is used for shoulder subluxation exercise One electrode pair is placed over the anterior and posterior deltoid muscles and the other over the supraspinatus and middle deltoid muscles The first pair of muscles lifts the humerus into the glenoid humerus socket while the second pair ma...

Страница 22: ...res 4 After use peel the electrode away from the skin by lifting its edge Do not pull the flying lead Replace the electrodes on their plastic sheet and remove the electrode lead by pulling the plug from the flying lead connector Do not pull on the electrode lead 5 Replace the electrodes in their plastic bag and reseal the bag to prevent evaporation of moisture from the electrode gel 6 If after rep...

Страница 23: ...enters the muscle Motor points are generally situated about 1 3rd from the proximal end of the muscle Muscles can also be activated by stimulating the motor nerve before it enters the muscle for example stimulating the common peroneal nerve as it crosses the head of the fibula bone will recruit all the muscles that dorsiflex and evert the foot and extend the toes Generally speaking the active elec...

Страница 24: ...t less thumb extension Swapping the active and indifferent electrodes will give stronger thumb extension but less wrist extension Choosing the electrode size is important to achieve the best effect Larger electrodes may be more comfortable to use as the current is spread over a larger area but may give undesirable effects because current may spread to more muscles and nerves than is required The b...

Страница 25: ...vement a Incorrect electrode positions refer to therapist s diagrams or contact your therapist b Incorrect level of stimulation the level may be too high or low c Incorrect electrode polarity may have been used refer to therapist s diagrams or contact your therapist d Poor electrode contact re apply or replace electrodes The movement produced is weaker than normal a Insufficient stimulation increa...

Страница 26: ...e form Nominally square with passive charge balancing 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 4 Item Expected service life Shelf life Microstim ...

Страница 27: ... 5 C to 27 C Alkaline Battery 20 C to 54 C System excluding above items 5 C to 40 C Electrodes 5 C to 27 C 1 month Electrodes 0 C to 40 C 1 month Alkaline Battery 5 C to 30 C System excluding above items 20 C to 70 C Relative humidity Electrodes 35 to 50 System Batteries 15 to 90 Electrodes 35 to 50 System Batteries 15 to 90 Atmospheric pressure 700hPa to 1060hPa 700hPa to 1060hPa Stimulator size ...

Страница 28: ...ase 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 Special Requirements The Microstim2 may be supplied with different parameters if required Please address any such requests to sales odstockmedical com 4 ...

Страница 29: ...29 Notes 4 ...

Страница 30: ...30 Notes 4 ...

Страница 31: ...31 Notes 4 ...

Страница 32: ...ry District Hospital Salisbury Wiltshire SP2 8BJ United Kingdom Registered Company No 5532620 Copyright Odstock Medical Limited 2008 2021 Revision 13 00 Manual Product Code 11 003 0008 QF 018 44 0 1722 439540 www odstockmedical com enquiries odstockmedical com 2797 ...

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