TecnoBody PROKIN-MF User manual

Használati Útmutató
PROKIN-MF/PROKIN-E
rendszer
PROKIN-MF / PROKIN-E
TecnoBody S.r.l.
Publikálva: 2015 január
Code-Version: MF-PK-MANOP-02-EN

TecnoBody S.r.l –PROKIN Systems
This document is in constantly updating.
© 2015. TecnoBody S.r.l. . All rights are reserved.
For more information and new versions of the note make reference to
the internet site :
www.tecnobody.com

TecnoBody S.r.l –PROKIN Systems
Index
OPERATOR’S MANUAL...................................................................................................... 7
SYMBOLS USED IN THIS MANUAL ................................................................................. 7
APPLICATION FOR USE .................................................................................................. 8
SAFETY GUIDELINES FOR INSTALLATION AND USE.................................................. 10
SYSTEM DETAILS ...........................................................................................................13
INSTALLATION STABILITY SYSTEM .................................................................................16
WHERE TO INSTALL THE SYSTEM...................................................................................18
ASSEMBLY PROKIN - MF SYSTEM ...................................................................................19
ASSEMBLY PROKIN - E SYSTEM ......................................................................................20
REQUIREMENTS AND CONNECTION TO THE PERSONAL COMPUTER ......................21
TECHINICAL DETAILS PROKIN-MF SYSTEM ...................................................................22
TECHINICAL DETAILS PROKIN- E SYSTEM .....................................................................23
FREEDOM DEGREES .........................................................................................................24
OPERATIONS ......................................................................................................................25
ADJUSTEMENT................................................................................................................25
SYSTEM ON/OFF SWITCH .............................................................................................26
DISCONNECT THE SYSTEM FROM NETWORK...............................................................29
MOBILE PLATFORM REFERENCES ..............................................................................30
PATIENT’S POSITIONING ON TWO-FOOTED PROKIN SYSTEMS..............................31
ANNEX A - Norms and Standards References....................................................................33
SYSTEM LABELING PROKIN-MF .......................................................................................34
SYSTEM LABELING PROKIN-E ..........................................................................................35
ANNEX B .................................................................................................................................42
Environment conditions ........................................................................................................42
System maintenance ............................................................................................................42
Operator’s maintenance .......................................................................................................43
ERROR MESSAGES ........................................................................................................44
ANNEX C - Warranty and Liabilities .....................................................................................46

TecnoBody S.r.l –PROKIN Systems
Thank you for having chosen to purchase a Tecnobody system.
The purpose of this manual is to provide a simple and clear description of the PROKIN
(PROKIN-MF/PROKIN-E)
system’s essential features and instructions on how to use it.
The documents that are provided with a STABILITY system have been divided into three
distinct manuals: The Operator’s Manual, the Software Manual and the Clinical Manual.
OPERATOR’S MANUAL
Code: MF-PK-MANOP-EN
The Operator’s Manual is provided both in a hardcopy (together with the
PROKIN system) and a digital version (in PDF-Acrobat format, in the CD
-
ROM software as well as in the application installed on Personal
Computer). All the directions provided in the Operator’s Manual must be
read very carefully and acknowledged by the operator prior to actually
beginning to use the system itself in any way whatsoever.
Generality
Installation of the PROKIN system
Contains a brief description of the system’s essential features and the procedures
required for a correct system
installation.
Technical features
This section of the manual provides specific directions that are aimed at ensuring the
operator fully understands the system operations, as well as the data supplied by the
application programs. Furthermore, it contains information on how to position the patient,
together with a set of safety rules and inst
ructions aimed at preventing patient injury. It is
necessary that all given directions and instructions are carefully adhered to at all times.
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SOFTWARE MANUAL
Code: MF-MANSW-EN
The Software Manual is provided in digital version (in PDF-
Acrobat
format, both in the CD-ROM software as well as in the application
installed on the Personal Computer).
• Software Installation
Provides all the necessary instructions for installing the system’s application program
packages onto your Personal Computer.
• Program description
Provides a description of the application software’s essential features, with a brief
summary of each individual function command.
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TecnoBody S.r.l –PROKIN Systems
CLINIC MANUAL
Code: MF-CLINICMAN-EN
The Clinical Manual is provided in digital version (in PDF-
Acrobat format, both in the CD-ROM software as well as in the
application installed on the Personal Computer).
• Clinical system application and assessment
Provides a detailed description of the correct procedures applicable to the proprioceptive
assessment phases, as well as providing essential directions on subsequent rehab
treatments.
To get regular software updates, it is essential that the client send, no later than one
month after installation of the system, the document titled Installation and Testing to
the TecnoBody offices.
This document will also be entitled to the warranty period.
TecnoBody References:
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PROKIN-MF /PROKIN-E SYSTEM – OPERATOR’S MANUAL
TecnoBody s.r.l.
Via Lodi N. 10 - 24044 Dalmine (Bergamo - Italia)
Tel. [phone] Fax. [phone]
Sito Internet..: www.tecnobody.com
e-mail [e-mail]

TecnoBody S.r.l –PROKIN Systems
OPERATOR’S MANUAL
SYMBOLS USED IN THIS MANUAL
DANGER
Text passages marked with this sign provide instructions that must be carefully followed in order
to avoid harm or injuries to the operator or to the patient.
CAUTION
Instructions under this sign must be carefully observed to avoid system or hardware damages.
NOTES
Notes providing important info and recommendations useful to system functions.
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TecnoBody S.r.l –PROKIN Systems
APPLICATION FOR USE
PROKIN Medical Device is a system that improves the quality of rehabilitation programs in
both orthopedic and neurological fields with many applications such as:
Functionalities:

EVALUATION AND TRAINING OF ORTHOSTATIC DYNAMIC
BALANCE;
EVALUATION AND TRAINING OF COGNITIVE CAPACITY AND
SENSORIMOTOR LEGS;
BIOFEEDBACK MUSCLE MOVEMENT EVALUATION AND TRAINING


ORTHOPEDICS REHABILITATION
- HIP PROSTHESIS – LIGAMENT INSTABILITY
- RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT
- RECONSTRUCTION OF THE CRUCIATE LIGAMENT
- KNEE PROSTHESIS
- LIGAMENT INSTABILTY
- PATELLAR CURTAINS
NEUROMOTOR REHABILITATION
RECOVERY OF THE MOTOR END OF THE LOWER ART WITH A CONTROLLED LOAD
ICTUS
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ICTUS
HEMIPLEGIA
ATAXIA
TROUBLES OF THE MOTOR KINESTETIC CONTROL
The Medical Device PROKIN, meaning "I measure," shall carry out its functions through a
detection system of forces applied on the floor’s adjustable corner. Specifically identified are:
• Variable loads from 0.1 to 150.0 kg with a resolution of 0.1 kg and precision of 0.5 kg;
• Variable tilt from +15° to -
15° in any directions and with a resolution of 0,2° and precision
of 0,5 °;
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TecnoBody S.r.l –PROKIN Systems
These metrological surveys allow for the identification of the loads and forces generated by
the human body in an orthostatic position and during flexion/extension of the joint.
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TecnoBody S.r.l –PROKIN Systems
SAFETY GUIDELINES FOR INSTALLATION AND USE
Read all the following instructions before installing the PROKIN system.
Do not use the system nearby water or any liquids that could fall
onto/into the device.
Never place the unit near radiators or other heat sources, where
there
is an explosive fire hazard, or where it is exposed to the elements
Never use the equipment in an environment with abnormal
atmospheric pressure and/or oxygen rich conditions.
Do not install and/or use any system in an environment in which there
are major magnetic sources
(diagnostic departments, radiotherapy
departments, MRIs, magneto therapy, etc.). In connection, never use
the system simultaneously in treatments or diagnostic tests that
provide for the presence of important sources of electromagnetism.
Do not install/use
any system in positions that prevent its physical
disconnection from the mains.
Do not operate the device in an improper configuration or when there is
a suspicion that it may cause harm to the patient.
Do not access the mechanical moving parts while making adjustments.
Do not insert your fingers into the cracks between floors during
adjustments in order avoid the risk of them getting trapped and
crushed
In normal operation, the patient's body is in contact with the supporting
surfaces of the PROKIN system
. The operator must then make sure
that this contact is hygienic and safe
The system must be used after a specific training phase by
professional staff (doctor, physiotherapist, graduated in physical
education). The system, however, comes with a clinical manual which
should be taken as a reference method for proprioceptive rehabilitation.
In normal operation, the operator or patient's body should not be in
direct contact with the power cables of the device or with the protective
fuses of the device itself.
Connect PROKIN system (read carefully the annex A) only to
electronic systems that follow normal guidelines in regards to electric
protection and correct positioning. Failure to comply with these
provisions shall also entail the forfeiture of the PROKIN guarantee
system.
Before cleaning the unit, disconnect the cables connected to it. For
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TecnoBody S.r.l –PROKIN Systems
detergents or alcohol. (This is confusing, it says to use a detergent and
then it says not to use detergents, I don’t know what is correct)
We do
not grant any changes to the system. Do not make any changes
other than the actions covered in the manual.
The system supports and works in efficiency for loads up to 150 kg, as
indicated by the labels; do not use with patients who weigh more than
this.
The system must be used only by professionals (medical practitioners,
physiotherapists or individuals with physical education and health
degrees) that have undergone specific training and are qualified to use
the system. The system is, nevertheless, supplied with a specific
clinical manual that must be referred to for the proprioceptive
rehabilitation application method(s).
For the basic operation of the system, there is no need for it to be used
in combination with other devices. If the operator decides to u
se it in
conjunction with other DM, it is necessary to make sure in advance that
such DM do not create interference in the operation of the system, and,
in particular, in accordance with that defined in the Electromagnetic
Compatibility.
For correct perfor
mance of the device it is summarized on the reliability
of the measurement functions of the device itself that you must do one
thing: measure the loads applied within the tolerances. To guarantee
effective performance, the PROKIN system must be subject to the
processes of maintenance and calibration on a schedule. See Annex B
for this information.
In case of detected change in the performance measurement of the
device (after a fault or occasional event), you should not use
the
system until it has been reset
through specific technical intervention
(re-calibration and / or repair) to the original levels of performance
Overall, there are no side effects or contraindications specific to
usage of the device.
Parts of the system applied to the PROKIN are
identified in the support
surface and in the body sensor (optional).
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For specific problems call TecnoBody for service
The cable and/or relative plug is/are damaged and/or worn.
Liquid has entered into the system or it has been exposed to rain.
The PROKIN
system doesn’t work (software or hardware damages)
after following the instructions. Only do the operation described in the
manual. A wrong operation can get serious damages, which may
require the intervention of a specialized technician.
The system received shocks or is damaged on the outside.
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TecnoBody S.r.l –PROKIN Systems
The Platform shows a significant deterioration in the operation, which
indicates the need of a revision.
The Platform does not seem properly calibrated for the loads applied
or inclinations measured.
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For all matters not otherwise
Operating Manual and Software
specified
and
provided
for
in
the
•
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TecnoBody S.r.l –PROKIN Systems
SYSTEM DETAILS
Let’s describe now, shortly, the working beginnings of the PROKIN system and let’s examine
the principal characteristics.
The system is made up, essentially, of a sensors net that takes every angular movement and
the applied load on a sophisticated tilting board.
When the patient interacts with the tilting board, the data acquired board changes every
single movement to electric impulses, sending them directly to the PC.
The electric impulses will be deciphered by the software and will show a tracing on the
computer monitor that corresponds to the angular movement in the tilting board or to the
applied load on it.
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TecnoBody S.r.l –PROKIN Systems
The obtained result is very important for both the patient and the operator.
The patient can see continuous visual feedback that allows him/her to establish a comparison
between what he feels at the proprioceptive and kinestesic level and what
he’s really
producing on the motor. With practice, the patient can gradually rebuild the correct map of
proprioceptive and kinestesic sensations.
For the specialized operator, there are three things needed to assess the innovative
contribution of the system in rehabilitation.
1-Precise assessment and the possibility to personalize the rehabilitation intervention.
This shows every interaction of the patient with the system on the computer monitor, by the
development of a tracing, so the doctor
can easily recognize if there are articular blocks, for
example, or a deficit at tonic-
muscular or neurosensorial level. Making an assessment, the
therapist can easily draw a series of “Rehabilitation Tracings” on the screen. In this way the
patient, follo
wing the rehabilitation route drawn by the therapist, can make, with precision and
constancy, the requested movement, without having troubles with wrong interpretations of the
deliveries.
Also, to make it easier for the therapist working on building rehabilitation tracings while
responding to functional troubles of the patient, the software contains some default
rehabilitation routes.
2-To save and to compare rehabilitation tracings.
The PROKIN-MF system can save rehabilitation tracings that have been obtained by the
patient and can insert them automatically into an electronic personal folder. The therapist,
using the folder-
patient management, can easily recall executed tracings from a specific
patient and to periodically check the evolution of the rehabilitation process.
The electronic archive is very useful to the therapist because it offers him/her the opportunity
to assess objectively, and with precision, the effectiveness of the rehabilitation actions,
without the possibility that they are being partially blocked with actual instruments.
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TecnoBody S.r.l –PROKIN Systems
3-To modify the active resistance and the instability of the tilting board.
The active resistance of the tilting board can be easily modified by four decelerator pistons.
This possibility allows the therapist to introduce tonic or trophic-
muscular work that is
modifiable in the base of requested work loaded.
Besides the active resistance, the tilting board can be modified sectorially, making a muscular
intervention that is diversified in relation to the trophic or tonic specific lacks and isolated by
the therapist possible.
Another funda
mental characteristic of the system is that it can modify the tilting board stability.
This characteristic allows the operator to modify the articular and neuromuscular activity that
is requested for the patient in relation to his conditions, or for the proposed Rehabilitation
Tracing.
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TecnoBody S.r.l –PROKIN Systems
INSTALLATION STABILITY SYSTEM
See the next chapter for more information about the assembly process of the system.
COMPONENTS
In all packing systems you will find the following components:
1
2
PROKIN-MF
/
PROKIN-E
3
4
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TecnoBody S.r.l –PROKIN Systems
1.
2.
PROKIN System (PROKIN -MF or PROKIN -E with Personal Computer).
N. 1 CD Rom. ( STABILITY-MF Software – Manuals in PDF format )
3.
Operator’s Manual, Configuration Documents, Check Certificate, CE certificate
4.
Trunk Sensor – Sensore Tronco
The CD-ROM, to avoid damage, it must be kept in a place free of dust
and away from heat sources.
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TecnoBody S.r.l –PROKIN Systems
WHERE TO INSTALL THE SYSTEM
The installation of a PROKIN system must be made by qualified TecnoBody
staff (TecnoBody staff or certificated reseller).
To correctly install the system, it is necessary to adhere to some general
rules:
Before starting the installation procedure of a PROKIN system,
carefully read the annex A of this manual.
•
Place the PROKIN system over a stable surface that is far from scales
or ramps. A soft surface can alter the response of the transducers
placed within the system and make them become unstable.
•
Choose a place protected from moisture and dust.
•
Keep the system away from potential sources of electromagnetic
interference, such as loudspeakers or mobile phones.
•
Ensure that in the space surrounding the system there is no furniture, equipment,
walls, or other objects that might pose a danger to the patient and /
or operator while
they are using the system.
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TecnoBody S.r.l –PROKIN Systems
ASSEMBLY PROKIN - MF SYSTEM
See the PROKIN assembly guide for the complete instructions on the assembly of the
PROKIN
“ PACKING LIST – ASSEMBLY PROCEDURE” /
PK-MF-ASSPRO.
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WOODEN
BASE
BASE
MAIN
STRUCTURE
HANDLES
TABLE
PC LCD SUPPORT
PC LCD TOUCH-SCREEN

TecnoBody S.r.l –PROKIN Systems
ASSEMBLY PROKIN - E SYSTEM
See the PROKIN - E assembly guide for the complete instructions on the
assembly of the
PROKIN - E
“ PACKING LIST –ASSEMBLY PROCEDURE” /
PE-ASSPRO.
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BASE
STRUCTURE
HANDLES
SUPPORTO PC LCD
PC LCD TOUCH-SCREEN

TecnoBody S.r.l –PROKIN Systems
REQUIREMENTS AND CONNECTION TO THE PERSONAL COMPUTER
The
PROKIN
system is composed, essentially, of two different units: the
Static Dynamic
Electric Platform and the Personal Computer
The Personal Computer is used for the connection with and the management of the Mobile
Electronic Board, which has the following minimum requirements for Hardware/Software.
The Personal Computer follows the directives 2004/108/EC (EMC) and 2006/95/EC(LVD) and
in particular the norms :
EN60950-1:2006 (A1:2009)
EN55022:2006-A1:2007
EN 55024::1998 (A1:2001,A2:2003)
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Components
Minimum Requirements
Operative system
Windows 7
Computer (cpu)
1.8-2.3 GHz
Memory
2-4 GByte
Space on the fix disk
10 GByte free of space on the hard disk
Monitor (Graphic schedule)
Monitor 16:9 resolution 1600x900 / 1366x768
Interface
Serial Port RS232