Steeper Myo Kinisi User manual
Distributeur
Myo Kinisi
Technical Manual
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 3
Contents
1. Box Contents ............................................................................................................................. 4
2. Features of the Myo Kinisi ..................................................................................................... 5
3. Steeper Myo Kinisi ................................................................................................................... 6
4. The Steeper Conguration Device ...................................................................................... 7
5. Important Clinician Information .......................................................................................... 8
6. Important User Information ............................................................................................... 11
7. Technical Information .......................................................................................................... 13
8. Environmental and Operational Conditions .................................................................. 14
9. The Function Button ............................................................................................................. 15
10. Specic Activity Use .............................................................................................................. 17
11. Activating the Auto-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 Replacement Palps .................................................................................................. 29
21. Donning the Cosmetic Glove ............................................................................................. 30
22. Dong the Cosmetic Glove ................................................................................................ 31
23. Warranty Terms ..................................................................................................................... 32
24. Returns ..................................................................................................................................... 33
25. Quality Assurance ................................................................................................................. 34
25. Test Certication .................................................................................................................... 35
27. Disposal .................................................................................................................................... 36
28. Symbols Used on Product & Packaging .......................................................................... 37
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual4
Box Contents
1
Myo Kinisi with PVC hand shell
Technical Manual (for clinician use)
User Guide (please supply to the end user)
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 5
Features of the Myo Kinisi
2
Independently controlled opening and closing speed options.
Integrated function button to turn the hand on/off.
Grip strength increase pattern allows the user to confidently increase their grip
when required.
Auto-grip feature allows the user 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 Steeper Configuration Device, which enables the choice
between Mode 0-4 for the Myo Kinisi (see the Steeper Configuration Device -
Programming Guide for Myo Kinisi).
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual6
3Steeper Myo Kinisi
The Myo Kinisi is a myo-electrically controlled terminal device designed for external
use by those with an upper limb absence. It is suitable for patients at levels equivalent
to transradial and more proximally, in both unilateral and bilateral applications. The
hand is available in three sizes (71/4”, 73/4” and 81/4”) and four wrist variations, to
suit a broad range of clinical presentations.
The Myo Kinisi oers an easy to control, highspeed grasp, with a strong maximum
grip force; promoting bi-manual manipulation and performing daily activities. The
device is supplied in Mode 1 ‘Dual Elec’ which provides a standard grip function and
the auto-grip feature is enabled. In combination with the Steeper Conguration
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 Conguration Device can be used to adjust the
parameters, including the speed and grip strength.
For optimum performance and extended capacity, it is recommended that the Myo
Kinisi is used alongside the Steeper S-Charge System and Steeper Electrodes.
A PVC hand shell encloses the inner mechanism to protect the Myo Kinisi and provide
a hand shape. Prior to providing the user with the Myo Kinisi, a Steeper cosmetic
glove must be tted to protect the hand shell. The Elegance Plus reinforced silicone
cosmetic glove is recommended and has been designed specically for use with the
Myo Kinisi.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 7
The Steeper Conguration Device
4
The Steeper Conguration Device oers prosthetists the choice between ve 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 Conguration Device.
More details about the modes available can be found on page 24.
The Steeper Conguration Device can be ordered using product code MYO-CFG via
Steeper Customer Services.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual8
Important Clinician Information
5
The Myo Kinisi must only be prescribed and tted by a qualied prosthetist
in a suitable clinical environment.
This Device is a Class I Medical Device which meets the general safety and
performance requirements in MDR 2017/745 Annex I.
Do not adjust, dismantle, attempt to maintain or modify the Myo Kinisi or its
associated components.
It is important the user inspects their myoelectric hand regularly to ensure
early detection of any problems.
Ensure that the hand is securely tted 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 enter the hand. If liquid/debris does enter the hand, it must
not be operated and should be returned for safety checks and/or repair.
In the event of device failure, or suspected malfunction, please contact
Steeper Customer Services or your local Steeper distributor.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 9
If a serious incident occurs, in relation to the device, it should be reported
to the Manufacturer and the competent authority of the Member State in
which the user and/or patient is established.
Important Clinician Information
5
Unless under clinical supervision, the user must always operate the hand
with the inner PVC shell tted.
To clean 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 ame 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 the power source, the user must
ensure that the Myo Kinisi is switched o, 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 o.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual10
Important Clinician Information
5
Do not use a combination of batteries with varying voltages to power the
hand.
Ensure the end user is fully informed of the care 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 Technical Manual.
WARNING: Do not modify this equipment.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 11
Important User Information
6
If your Myo Kinisi has been tted with a Quick Disconnect Wrist, the device
must be consciously positioned when performing any turning actions to
prevent unintentional disconnection of the hand atthe wrist.
When driving, the hand must be turned o, and in a position that prevents
the permanent connection between the device and the vehicle. Driving with
the Myo Kinisi switched on may result in accidental/unintentional operation
of the hand, presenting a signicant 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 ame or excessive heat. Avoid exposing
the hand to long periods of direct sunlight.
The prosthesis must not be worn whilst the batteries are charging.
Whilst the battery pack is being charged, the hand will not function.
Do not touch any live electrical equipment with the hand.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual12
Important User Information
6
The Myo Kinisi must not be used during extreme sports. Steeper does not
accept any responsibility for damage or injury due to improper use.
Do not store device in fully closed position, always store with ngers and
thumb slightly open.
The maximum carry load for the Myo Kinisi is 12.5kg (27.55lb).
Before detaching the Myo Kinisi from the prosthesis, you must ensure
that the Myo Kinisi is switched o, 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 o.
In the event that the device or prosthesis is exposed to unusual substances
or stresses, please stop using the device immediately and contact your
prosthetist to arrange an inspection, and return for repair if required.
Please visit www.steepergroup.com for the latest version of the User Guide.
WARNING: Do not modify this equipment.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 13
7Technical Information
Hand sizes*: 7¼” 7¾” 8¼”
Maximum opening width 100mm (3.9”) 100mm (3.9”) 100mm (3.9”)
Maximum length -
ngertip 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.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual14
Environmental and Operational Conditions
8
Storage 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
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 15
The Function Button
9
The Myo Kinisi has a low prole function button, located on the back of the hand (as
shown in the diagram).
The Myo Kinisi is on by default after connecting to a power source; initial start
up of the device will take between 2-4 seconds after 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 button (see p.17 for more details).
Location of the Function Button. This switches the device ON/OFF and is
used to activate the auto-grip feature.
Press here
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual16
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
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 17
Specic Activity Use
10
The hand must be turned o during an activity that requires it to remain in the
same position for long periods of time, or when the user wants to prevent accidental
operation of the device - particularly if associated muscle contractions in the residual
limb will occur. The function button is used to power the hand o.
If the Myo Kinisi has been tted with a Quick Disconnect Wrist, the device must
be consciously 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 o, 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, potentially causing loss of vehicle control and injury as a
result.
It is the responsibility of each user to ensure they comply with local regulations
before operating any motorised vehicle.
Note: Steeper recommends assessment from an authorised/specialist test centre to
determine if the user’s vehicle requires any adaptations.
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual18
Activating the Auto-Grip Feature
11
The auto-grip feature is designed to give the user greater condence when
grasping objects. When gripping an object, this feature will oer a grip strength that
automatically adjusts to accommodate for any slip of the gripped object.
Prosthetists can enable/disable this feature using the Steeper Conguration Device.
Auto-grip utilises the function button; please see page 14 for a diagram of location.
To operate:
The hand must be in an open position and 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 minute; otherwise the auto-grip function will automatically deactivate.
If the object is removed, the hand will close.
When engaged, auto-grip is cancelled by a strong open signal, or after 2 minutes
if the gripped object does not slip.
Auto-grip can also be cancelled by pressing the function button a second time
before gripping the object (producing a double burst haptic vibration).
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual 19
Mechanical Safety Release
12
In the event in that the grip cannot be released, such as a loss of power to the Myo
Kinisi, the safety release button can be used to disengage the thumb.
The safety release button is located on the outside of the thumb. Press this rmly
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 condent in how to safely manoeuvre the safety release back into its
correct position. A video guide can be found on the Steeper website www.
steepergroup.com.
Caution: This must only be used in the event of loss of power on the ...
Press firmly here
EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual20
Re-engaging the safety release:
To reset the mechanical safety release, push the button and move the thumb
back to its original position, you will 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 activities.
Mechanical Safety Release
12
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