Steeper Myo Kinisi Page 38 Technical Manual Download

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Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.

Myo Kinisi Technical Manual

Symbol

Definition

Source

Indicates the medical device may be

used multiple times (multiple

procedures) on a single patient.

ISO/DIS 15223- 1:2020(E)

Reference no. 5.4.12.

(ISO 7000-3706)

Mobius logo indicates that the marked

item or its material is part of a recovery

or recycling process.

ISO 704, ISO/IEC 13251,

ISO 10987-1, ISO 9687

(Reference no. IS0 7000

-1135)

Packaging is covered by the Forest

Stewardship Council assurance that it

is made with, or contains, forest-based

materials from FSC-certified forests or

reclaimed sources.

FSC Certification

Symbols Used on Product & Packaging

Summary of Contents for Myo Kinisi

Page 1: ...Distributeur Myo Kinisi Technical Manual ...

Page 2: ......

Page 3: ... Grip Feature 18 12 Mechanical Safety Release 19 13 Additional Safety Feature 21 14 Maximum Pulses 22 15 Myo Kinisi Control Parameters 23 16 Adjustable Parameters Table 24 17 Myo Kinisi Mode Overview 25 17 1 Mode 0 AUTO CLOSE 25 17 2 Mode 1 DUAL ELEC 25 17 3 Mode 2 QUICK OPEN 26 17 4 Mode 3 ALTERNATE 26 17 5 Mode 4 PULSE 26 18 Removing the Hand Shell 27 19 Fitting the Hand Shell 28 20 Fitting Repl...

Page 4: ...Myo Kinisi van Steeper distributeur Loth Fabenim B V Myo Kinisi Technical Manual 4 Box Contents 1 Myo Kinisi with PVC hand shell Technical Manual for clinician use User Guide please supply to the end user ...

Page 5: ...er to have a secure grasp on unstable objects Compatible with the Steeper Quick Disconnect Wrist Friction Wrist and Short Wrist ranges M12 or 1 2 x 20 TPI threaded stems Recommended for use with the Steeper S Charge System other 6 8 4V power systems are compatible however these may restrict capacity Independently operated mechanical safety feature Durable PVC hand shell Programmed using the Steepe...

Page 6: ...rovides a standard grip function and the auto grip feature is enabled In combination with the Steeper Configuration Device the Myo Kinisi operational Mode 0 4 can be changed threshold settings can be manipulated and the auto grip feature can be enabled or disabled Dependant on the user s ability the Steeper Configuration Device can be used to adjust the parameters including the speed and grip stre...

Page 7: ...prosthetists the choice between five modes to suit patient needs The Myo Kinisi is supplied in Mode 1 Dual Elec the parameters of this mode can be adjusted using the Steeper Configuration Device More details about the modes available can be found on page 24 The Steeper Configuration Device can be ordered using product code MYO CFG via Steeper Customer Services ...

Page 8: ...s important the user inspects their myoelectric hand regularly to ensure early detection of any problems Ensure that the hand is securely fitted to the wrist plate of choice for the hand to function If the Myo Kinisi is not functioning as expected check the electrode connection connectors are not damaged The Myo Kinisi is not dirt resistant or waterproof therefore moisture and or debris must not e...

Page 9: ...the outer glove or the hand shell use a damp cloth to gently remove any marks Do not use solvents Do not expose the Myo Kinisi to a naked flame or excessive heat Avoid exposing the hand to long periods of direct sunlight Do not expose the Myo Kinisi to any live electrical components Do not subject the hand to any impact mechanical vibrations or excessive load Before detaching the Myo Kinisi from t...

Page 10: ...are and operation of this product A User Guide will be supplied with the hand for their reference This product is intended for use by a single user during daily activities See warranty terms for further information If this product does not meet your expectations please contact Steeper Customer Services or your local Steeper distributor See www steepergroup com for the latest version of this Techni...

Page 11: ...d the vehicle Driving with the Myo Kinisi switched on may result in accidental unintentional operation of the hand presenting a significant risk of losing control of the vehicle and injury as a result If exposed to salt water contact your prosthetist immediately to arrange an inspection and return to Steeper for repair if required Do not expose the device to a naked flame or excessive heat Avoid e...

Page 12: ...5kg 27 55lb Before detaching the Myo Kinisi from the prosthesis you must ensure that the Myo Kinisi is switched off press and hold the function button as described in Location of the Function Button p 14 and then check the hand functionality to ensure it is switched off In the event that the device or prosthesis is exposed to unusual substances or stresses please stop using the device immediately ...

Page 13: ...h 100mm 3 9 100mm 3 9 100mm 3 9 Maximum length fingertip to hand base 170mm 6 7 170mm 6 7 175mm 6 89 Maximum speed when closing from fully open 220mm s 220mm s 220mm s Compatible with wrist sizes 45mm 1 77 50mm 1 97 54mm 2 16 Weight of device with EQD Wrist and hand shell 530g 550g 565g Grip force c 90N c 90N c 90N All figures are for guidance only ...

Page 14: ...rage and Transport 20 C 4 F to 50 C 122 F If the hand has been in storage or has been transported place the device in an ambient temperature 20 C two hours prior to using Operational 5 C 23 F to 40 C 104 F Pressure Range 700 1060 hPA Maximum 80 relative humidity non condensing Do not expose to EM emissions above 8kV contact 15kV air ...

Page 15: ... which you can operate the device To switch off the device press and hold the button for 3 seconds a feedback vibration will indicate that the device is switching off To switch the Myo Kinisi back on press the function button for for 1 second a vibration feedback will indicate the device is on When the device is on the auto grip function can be activated by pressing and releasing the function butt...

Page 16: ...isi Technical Manual 16 Note The force required to press this button has been designed to avoid accidental operation Note If the Myo Kinisi is not functioning this will likely be because the system is off press the button firmly to turn it on The Function Button 9 ...

Page 17: ...onsciously positioned when performing any turning actions to prevent unintentional disconnection of the hand at the wrist Whilst using the hand if the user is intending to drive they MUST ensure the device is turned off and in a position which allows them to easily disconnect the hand from the vehicle Driving with the power on may result in accidental unintentional operation of the hand potentiall...

Page 18: ...powered on Press and release the function button to activate auto grip a single short burst haptic vibration will indicate that the auto grip is active Close the hand onto the object until the grip force increases to elicit 1 pulse Auto grip is now engaged ensuring the grip strength applied to the object is maintained Once auto grip is active the hand must be engaged in gripping an object within 1...

Page 19: ...ted on the outside of the thumb Press this firmly and push the top of the thumb open to activate the safety release Important Clinician Information The safety release function must be demonstrated to the patient prior to leaving the clinic The patient must be confident in how to safely manoeuvre the safety release back into its correct position A video guide can be found on the Steeper website www...

Page 20: ...then feel it relocate To check if the thumb has re engaged ask the user to close the hand if the thumb moves accordingly it has been reset correctly The mechanical safety release will work with the hand in either an open or closed position and will not require recalibration if deployed To ensure the thumb is functioning as expected the user must grip an object before commencing with further activi...

Page 21: ...l Safety Feature 13 When the battery runs low the hand will slow this is intentional to signal the user to recharge or change their battery If the battery fully discharges during use as a final action the Myo Kinisi will open and remain in an open position until the battery is recharged or changed ...

Page 22: ...es 14 The grip can be maximised by maintaining or pulsing the close signal after gripping an object A number of pulses will be felt as the grip increases This feature incrementally increases grip to the pre set maximum pulse count 1 3 When the maximum pulse count is achieved the grip is at a maximum ...

Page 23: ...e selection based on the need of the user These modes cannot be selected or adjusted without the use of the Steeper Configuration Device The table adjacent illustrates the key attributes of each of the five modes Control Mode No of Sites Compatible Inputs Control Strategy Auto Grip Opening Closing Single Dual AC DC Electrode Force Sensitive Resistor FSR Switch Linear Transducer Threshold Proportio...

Page 24: ... with each of the five Myo Kinisi hand modes are illustrated in the table below Control Mode Invert Flip Electrodes Auto Grip Electrode Mode Input 1 Input 2 Control Parameters Highest First Close priority ON Level Max Level ON Level MAX Level Max Open Speed Max Close Speed Pulse Period Alt Delay Max Pulses 0 1 2 3 4 Only available when using a Proportional mode ...

Page 25: ...Pulses Count of 3 An input signal must pass the ON Level threshold to elicit movement in a respective direction The method for changing direction of movement is Highest by default meaning that the largest signal will take priority to determine the direction of the hand When the First Signal option is selected the first electrode to increase above its ON Level threshold will determine the direction...

Page 26: ...initial signal Single Site 2 Channel Signal A short burst input signal will open the terminal device to close the device the user must provide a long burst signal A short burst signal is an input signal that rises to 400 of the ON Level threshold and falls back below the ON Level threshold within a programmable Pulse Period A long burst signal is an input signal that is sustained for a longer than...

Page 27: ...refully work the inner hand shell distally on the chassis Ensure the fingers are worked free from the palps throughout the process until the hand shell can be lifted off Some gentle external heating of the inner hand shell can aid the process however extreme care must be taken not to heat the internal mechanism Do not put the hand in the oven Note The inner hand shell should only be removed if the...

Page 28: ...mmended The PVC hand shell can be gently heated to aid the donning process place the hand shell on to a clean flat surface in a fan assisted oven at 110 C 230 F for 90 seconds When the hand shell is warm and malleable carefully ease the wrist section over the fingers before pulling over the chassis Once partially donned the inner hand shell should be pushed down fully into place so that there is n...

Page 29: ...and cosmetic hand shell as per the instructions within in this manual Gently pull off the damaged palp s ensuring unnecessary damage is not inflicted to the fingers or hand The surface must be cleaned with IPA or equivalent prior to the palp being replaced Replacement palps are a push on fit but for additional security super glue must be applied sparingly to the thumb or fingertips beforehand Care...

Page 30: ...oid localised overheating If applying a silicone glove no heating is required Pull the glove over the hand manipulating it carefully to avoid excessive stretching Once the fingertips of the device meet the palm of the glove carefully push the glove down into position over the fingers and thumb The cosmetic glove should fit closely all over the fingers and the thumb and cover the hand When extended...

Page 31: ...htly open the hand and isolate the power supply Apply a water based surgical lubricant to the outer glove surface before inverting the glove and pulling the proximal edge back over the hand distally in a firm action Avoid cutting off the cosmetic glove where possible to prevent risk of damaging the inner hand shell beneath Doffing the Cosmetic Glove 22 ...

Page 32: ...es back to Steeper The warranty will be void on all system components if any components have been subject to abuse modification neglect deliberate damage loads beyond those for which the product was designed or repair or maintenance by an uncertified person The design and manufacture of Steeper equipment and components are subject to a policy of continuous reappraisal The company therefore reserve...

Page 33: ...turns Authorisation Number and 8 2 1 FRM 028 Product Concern Report Form All items must be returned to Steeper with an RTA and completed 8 2 1 FRM 028 Product Concern Report with the product return The RTA number must be clearly stated on the outside of the packaging prior to return The serial number found under the hand shell close to the wrist as per photo must be added to the Serial No section ...

Page 34: ...on N 9612243 Model N RP628 This Device complies with the requirements of the Medical Device Regulations MDR 2017 745 The design and manufacture of Steeper equipment and components are subject to a policy of continuous reappraisal The company therefore reserves the right to introduce changes and withdraw products without notice This device is CE marked to confirm the device is compliant with EU Leg...

Page 35: ...he Device and its associated components listed within this document have been tested and certified to the following standard and requirements IEC 60601 1 2005 AMD 2012 IEC 60601 1 11 2015 IEC 60601 1 2 2014 RTCA DO 160G Includes meeting requirements of ISO 14971 2019 Test Certification 26 ...

Page 36: ...posing of this product correctly will help save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling Please contact your local authority for further details regarding your nearest designated collection point Penalties may be applicable for incorrect disposal of this waste in accordance with y...

Page 37: ...uidance using the ukca marking Indicates a carrier that contains Unique Device Identifier information MDR 2017 745 23 2 h ISO 15223 1 2016 Indicates the manufacturer s batch code so that the batch or lot can be identified ISO 15223 1 2016 Reference no 5 1 5 ISO 7000 2492 Indicates the item is a medical device ISO DIS 15223 1 2020 Reference 5 7 7 Indicates a medical device that has not been subject...

Page 38: ...E Reference no 5 4 12 ISO 7000 3706 Mobius logo indicates that the marked item or its material is part of a recovery or recycling process ISO 704 ISO IEC 13251 ISO 10987 1 ISO 9687 Reference no IS0 7000 1135 Packaging is covered by the Forest Stewardship Council assurance that it is made with or contains forest based materials from FSC certified forests or reclaimed sources FSC Certification Symbo...

Page 39: ...EN Myo Kinisi van Steeper distributeur Loth Fabenim B V Myo Kinisi Technical Manual 39 ...

Page 40: ...ct us if you find any page missing or disordered Contact Loth Fabenim B V De Liesbosch 14 G 3439 LC Nieuwegein THE NETHERLANDS Tel 31 30 27 32 506 Fax 31 30 27 11 045 Email sales lothfabenim nl www lothfabenim nl Manufacture Authorized representative for EU countries Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Tel 31 70 345 8570 Email EmergoEurope ul com ...

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