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MediTouch BalanceTutor BT100 User Manual

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BalanceTutor user manual 200824.doc
BalanceTutor™
User Manual
July 2020
BalanceTutor a dynamic and static postural control trainer
45 Hamelacha, Poleg industrial zone, Netanya, Israel.
Zip: 42505, PO Box: 8306
Page 1 of 85
www.meditouch.co.il
info@meditouch.co.il
DO-15-01-02

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  • Page 1 BalanceTutor™ User Manual July 2020 BalanceTutor a dynamic and static postural control trainer www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 1 of 85 BalanceTutor user manual 200824.doc DO-15-01-02...
  • Page 2 This manual covers operation procedures for the following MediTouch product: BalanceTutor BT100 The BalanceTutor by MediTouch is a Perturbation Treadmill designed for postural control training has been tested to IEC medical standards for electrical safety. It is a Class I, Type BF device.

  • Page 3: User Responsibility

    Should such repair or replacement become necessary, it is recommended that a telephone or written request for service advice be made to MediTouch This Product or any of its parts should not be repaired other than in accordance with instructions provided by MediTouch authorized representatives or by MediTouch Trained personnel.

  • Page 4: Table Of Contents

    Contents User Responsibility................................3 MediTouch Contact Information ............................3 Device description ................................8 1 Safety, Warnings, Precautions, Prohibitions ....................9 1.1 Electric safety / safety classes ........................10 1.2 Patient and Therapist security according to IEC 601-1 ................10 ............... 10 1.3 Connection of units installed outside medically utilized locations...
  • Page 5 ..........................58 4.4.3 System Hardening ..........................59 4.4.4 Automatic System Log Off ........................60 4.5 Data Export ..............................60 www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 5 of 85 BalanceTutor user manual 200824.doc...
  • Page 6 ......................74 6.1.6 Multi-Task ............................74 6.1.7 Standing Stability ..........................74 6.1.8 Walking Stability ..........................74 www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 6 of 85 BalanceTutor user manual 200824.doc...
  • Page 7 ................................ 85 12.1 Disassemble and cut up ..........................85 13 Appendix ..............................85 13.1 Instruction & Commissioning ........................85 www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 7 of 85 BalanceTutor user manual 200824.doc...

  • Page 8: Device Description

    Device description The BalanceTutor by MediTouch is a Perturbation Treadmill that is an innovative device for postural control and balance trainer. The device consists of a treadmill mounted on a moving force plate platform. The platform moves in the medial/ lateral and forward/ backward plains to simulate a slip and a trip in both the standing and walking phase.

  • Page 9: Safety, Warnings, Precautions, Prohibitions

     If there are faults or abnormal or if there is evidence of damage (e.g. unusual sounds), the training session must be stopped immediately and a MediTouch authorized technician must be informed without delay.

  • Page 10: Electric Safety / Safety Classes

    1.3 Connection of units installed outside medically utilized locations If units installed outside medically utilized locations (e.g. external printer, host computer etc.) are connected to a MediTouch unit installed in a medically utilized location the VDE 0750 regulations must be observed. Connection only via: 1.

  • Page 11: Protection Against The Danger Of Electrical Shocks

    1.5 Environmental requirements MediTouch systems are not to be used in medically utilized rooms with a danger of explosions or in easily inflammable atmospheres. The devices must not be installed near to e.g. an x-ray device, motors or transformer with high connection power, as the electric and magnetic interference can falsify measurements or even make them impossible.

  • Page 12: Economic Life-Time

    (at damage or unusual heavy duty possibly earlier) and the recommended maintenance intervals are kept. Every maintenance and repair work needs to be carried out by authorized MediTouch technicians. For expendable parts a shorter life-time is due. 1.7 Labels, Locations, Interpretations Read and understand the labels on the BalanceTutor.

  • Page 13: Name Plate

    Symbol for collection, treatment, recycling and disposal of waste electrical and electronic equipment (WEEE) as set out in Directive 2002/96/EC of 27 January 2003 of the European Parliament and of the Council on waste electrical and electronic equipment www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 14: Warning Labels

    The high voltage can cause serious injury or death. Only a qualified MediTouch Service Technician should attempt any repairs in these areas. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 15: Safety Standards, Norms

    1.7.4 Safety standards, norms All MediTouch systems are produced according to strict safety and quality controls. The product must not be used, if the certificates/permissions and the (according to the list of technical specifications) defined safety standards do not correspond with the local and country-specific requirements.

  • Page 16: Intended Use - Indications

    1.8.4 Sport Training  Rehabilitation after sport injury  Athletes training 1.8.5 Aging  Fall prevention  ADL activities improvement www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 16 of 85 BalanceTutor user manual 200824.doc...

  • Page 17: Special Care In Use

    ! Soft tissue damage such as Muscle or ligaments tear. ! ACL/PCL restoration of Knee ! Droop foot ! Limb prosthesis ! Joint replacement like Hip, knee and Ankle. ! Epilepsy www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 17 of 85 BalanceTutor user manual 200824.doc...

  • Page 18: Forbidden Use - Contraindications

    1.10 Clinical guidelines When an unexpected perturbation is happening, Center of Mass (COM) is passively moving toward the perturbation direction. The body needs to react immediately (70-120 ms) to restrain this www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.
  • Page 19  High level coordination of ankle agonist and antagonist muscle activation Target: Ankle instability rehabilitation Technique: Multi-Direction Unexpected Perturbation Clinical effect:  High Level ankle neuromuscular coordination www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 20  Fast contraction of Iliopsoas through automatic response at swing phase Target: Hip extension rehabilitation Technique: Backward to Forward Perturbation while standing and walking Clinical effect:  Fast contraction of Gluteus maximus through automatic response www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 21 At the suspicion of unauthorized access or other reasons to lock the BalanceTutor device, the system has to be locked, signed as „blocked“ and secured against use (for example, unplug the power cord and to affix warning label). www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 22: Installation & Commissioning

    Pre-installation Technical training 2 hour Distributor qualified technician On site Hospital clinical staff Clinical training 1 day Distributor or MediTouch clinician Remotely, On Hospital clinical staff site (optional) 2.2 Staff members qualification ROLL MINIMAL QUALIFICATION SKILLS Distributor technician Mature technical skills. Solid understanding in mechanical assembly and maintenance and good understanding in electricity and electronics.

  • Page 23: Device Installation Schematics

    Floor cable cover Internet line (Optional) Power line Isolation transformer (acts as a ON/OFF device power) KEEP OUT zone sticker (on floor) www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 23 of 85 BalanceTutor user manual 200824.doc...

  • Page 24: Installation Preparation Form

    SITE DETAILS Organization name: ____________________________________________________________ Full address: ____________________________________________________________ Contact person: ____________________________________________________________ Tel: ____________________________________________________________ Mobile: ____________________________________________________________ Scan and email to: info@meditouch.co.il Confirmed by: __________________ __________________ Full Name Signature www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...

  • Page 25: Installation Procedure

    In order perform installation and to be familiar with the product's maintenance procedures, please refer to the following document: File name: BalanceTutor Service Manual File number: DO-15-01-12 www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 25 of 85 BalanceTutor user manual 200824.doc...

  • Page 26: Transport, Unpacking & Packaging

    Ask your dealer and the carrier to take the packaging and the recyclable transport tool back to your dealer or to MediTouch at your own costs. In some cases, a credit note can be granted. Special packaging and/or carrier constructions must not be disposed unauthorized.

  • Page 27: Mechanical Installation

     The bearing capacity of floor and ceiling in the building must be higher than the weight of the machine. It has to be approved for the MediTouch device by an authorized body of the operator. Example BalanceTutor in standard configuration, Dimensions ground frame unweighting system: L 232 cm x W 161 cm = 3.74 m²...
  • Page 28  Damaged leads and couplers and defective or dirty contacts have to be exchanged immediately. Rubber-leads can get porous and friable after some years.  For further questions please ask your electrical engineer or MediTouch.  Plug the device directly into the wall socket with checked ground wire. Device has to be connected to a separate circuit.

  • Page 29: Instructions For Use

    BalanceTutor. A detailed information of the installation and check list of all the tests performed, need to be delivered to the customer. Ask from the encharged of the installation a Summery Report (MediTouch reff. # DO-15-01-13). www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 30: Switching The Device On

    [01] During the treatment the patient can enjoy from instructions and juidance about the current state of the treatment presented at the patient’s screen. [02] www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 30 of 85 BalanceTutor user manual 200824.doc...

  • Page 31: Switching The Device Off

    The intervals of switching off- and on must not be shorter than 1-2 minutes. Otherwise it could lead to interference.  The system should be unplugged in case of longer breaks (for example overnight). www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...

  • Page 32: Software Operation

    In order the perturbation platform be located in the center of the device, a homing procedure required. By pressing OK, the platform will move one time to the right then return to the exact center of the device. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 33: Patient List

    4.3.3 Patient List In this stage you can create new patients, edit there profile and selecting a specific patient to start work with. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 33 of 85 BalanceTutor user manual 200824.doc...

  • Page 34: Operational Modes

    A series of examinations to quantify postural control abilities Session Log Documentation and follow up of patient’s progress A series of treatments based on patient’s Center Of Pressure controlling www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...

  • Page 35: Trigger Treatment

    Swing phase and Stance phase automatically. This mode compused of 3 main stages (Baseline, Setup and Treatment) as described as follows: www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.
  • Page 36 Baseline The Baseline stage is designed to set the walking speed and Perturbation intensities in four directions according to patinet’s abilities and rehabilitation needs. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 36 of 85 BalanceTutor user manual 200824.doc...
  • Page 37 4.3.5.4.1 Choosing from existing protocol Protocols The therapist chooses the specific protocol out of the protocol list and then presses the select button. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 38 7. After building of session as described above press Save to complete the protocol definishion www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 38 of 85 BalanceTutor user manual 200824.doc...

  • Page 39: Muscle Training

    The muscle training mode is designed to set the kind of the perturbation according to the anatomy of the body. Select Muscle Choose the area of the body as the aim of the rehabilitation. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...

  • Page 40: Evaluations

    4.3.7 Evaluations The evaluation mode is designed to evaluate Walking ability, Standing stability and Postural analysis. 4.3.7.1 Gait Analysis www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 40 of 85 BalanceTutor user manual 200824.doc...
  • Page 41 Set the standing position, direction of the perturbation, level of the perturbation and start. Press save to document the evaluation.  Comment Choose the standing position according to patient ability. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...
  • Page 42 7. A report detailing stance postiion and direction and amplitude of perturbation together with the resulting reactive response is generated for the therapy records www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 43 Distance in mm from first overshoot to first undershoot COP Travel [mm]: Sum of the total length of COP excursions between perturbation event and return to resting sway www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...

  • Page 44: Reports

    Therefore these objective measures allow the therapist to better customize reactive response training and improve balance and gait ability. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.
  • Page 45 4.3.8.1 Gait Analysis Single report: Accumulated data report: www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 45 of 85 BalanceTutor user manual 200824.doc DO-15-01-02...
  • Page 46 A stage in stance phase, at which only one foot is in contact with the ground. Double Support (% of gait cycle) A stage that both feet are simultaneously in the stance phase www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...
  • Page 47 Normal Range An average of normal gait spatio-temporal parameters of adults. Bogdan Pietraszewski et al, 2012 http://www.actabio.pwr.wroc.pl/Vol14No3/2.pdf www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 47 of 85 BalanceTutor user manual 200824.doc...
  • Page 48 Documentation for accumulated records: www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 48 of 85 BalanceTutor user manual 200824.doc DO-15-01-02...
  • Page 49 4.3.8.2 Standing Stability Documentation for accumulated records: www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 49 of 85 BalanceTutor user manual 200824.doc DO-15-01-02...
  • Page 50 4.3.8.3 Postural Analysis Documentation for accumulated records: www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 50 of 85 BalanceTutor user manual 200824.doc DO-15-01-02...
  • Page 51 Peak Peak-to-peak amplitude is the change between peak (highest and lowest amplitude value. COP Travel The total distance that the cop is moving. (COp excursion) www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 51 of 85 BalanceTutor user manual 200824.doc...

  • Page 52: Session Log

    4.3.9.1 Baseline Baseline report can be generated by clicking on the appropriate label in the top icons. These report can be printed or saved as pdf files. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 53 4.3.9.2 Treatments Treatments report can be generated by clicking on the appropriate label in the top icons. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 53 of 85 BalanceTutor user manual 200824.doc...

  • Page 54: Cop

    The COP task have been desgined to facilitate repetitions of isolated weight shifting practice in any stance positon. The practice cabn be customized according to the patient’s weight shifting movement ability and the therapists objective for practice. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.
  • Page 55 Or press automatic to generate targets  Press start to commence the  Comment No force can be applied to force plate apart from patient www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 56  Check Range icone on left  Set treatmetn parametrs according to patient’s ability  Press start  Comment No force can be applied to force plate apart from patient www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...

  • Page 57: System Security

    3. Fill in the details of the new user and select Position as Operator 4. Press Save 5. A new user will be added to the left users list www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...

  • Page 58: Anonymous Patient

    6. Press Save Following this process patient will be added with initials only and a four digit identifier number created by the user as demonstrated in the following example. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...

  • Page 59: System Hardening

    The SSD (Solid State Drive) within the embedded computer of the BalanceTutor my can configured to be solidified. There is an option supplied by MediTouch IT team to disable the ability of deleting or inserting files to the file system in order to protect the integrity of the operation system the www.meditouch.co.il...

  • Page 60: Automatic System Log Off

    1. Select a patient 2. Go Evaluation or Sessions Log 3. Choose a Report 4. Click the Save icon 5. Save file in computers’ directory www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 60 of 85 BalanceTutor user manual 200824.doc...
  • Page 61 Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 61 of 85 BalanceTutor user manual 200824.doc DO-15-01-02...

  • Page 62: Csv

    2. Press the Setting button  Press Parameters 3. Press Edit and Check the Sensors Logger box * Evaluations may also be saved by checking the Save Evaluation Locally box as well 4. Press Save www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...
  • Page 63 All CSV files can be extracted to a comfortable visual view using Matlab *.m file procedure. Please see the following an example describing COP behavior during perturbations. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...

  • Page 64: System Messages

    Failed to analayze recorded data from the Fault COP sensory system. It caused because no one is standing on the platform. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 65 Change in Baseline will lead a warning Warning message for a new set of perturbation intensities will be next on in treatments. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 65 of 85 BalanceTutor user manual 200824.doc...

  • Page 66: Version Identifier

    4.7 Version identifier Each version of the BalanceTutor software has a unique version number that could be detected from the bottom right screen. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 66 of 85 BalanceTutor user manual 200824.doc...

  • Page 67: Training

    Avoid pressure around the chest and around the legs. The vest must support the person from the legs, not from the chest, arms, ribs or hips. Always fasten the straps in the order given in these instructions. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 68: Sizes

    5.2.2 Sizes Description MediTouch P/N Fall Protection Harness S DS-06-01-02-A Fall Protection Harness UNI DS-06-01-01-A Fall Protection Harness XL DS-06-01-03-A Standards: CE EN361, CE EN358, CE EN1497 5.2.3 Harness features 5.2.4 Trigger positioning lanyar www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 69: Harness Setup

    Adjust harness level to patient's height using the red trigger adjuster. STAGE 2 – Wearing the harness Wear the harness and confirm its height according the image. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...
  • Page 70 STAGE 5 – Tension adjustment Adjust rope tension using the red trigger adjuster to allow; A. Secured height in case of a fall. B. Comfortable movement tolerance. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935...

  • Page 71: General Advice For Training

    In general, the increase in the speed of movements should be adapted individually to the progress the user is making during treatment. Selecting www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 72: Training Troubleshooting

    5.9 At the end of a training day  Switch OFF the BalanceTutor according to the manufacturers’ orders.  Pull the plug out of the socket, to separate the BalanceTutor from the current. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 73: Clinical Guidelines

    Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 74: Muscle Activation

    6.1.8 Walking Stability BalanceTutor system allows for providing customized Perturbation Based- Balance Training to improve Proactive and Reactive responses also in walking in addition to standing position. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...
  • Page 75 Walking stability training using BalanceTutor can be achieved by practicing of computerized perturbation according to specific Gait phase such as Stance, Swing or Double Support phase during the walking. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il...

  • Page 76: Maintenance & Safety Inspections

    7 Maintenance & Safety Inspections The MediTouch authorized service engineers are happy to help you in the case of occurring problems. A preventive maintenance can avoid problems in the future and is indispensable for the safety of such technical devices. Therefore, ask for an annual preventive maintenance contract, which is highly recommended by the manufacturer, from our service department.

  • Page 77: Treadmill Belt Set To The Correct Tension

    7.3 Regular inspections/examinations Following list will containe which elements to be examined or inspected every year by MediTouch or any any technical personel authorized by MediTouch:  Check metal construction for: Visual damage, rust, paint scraped, metal deformation.

  • Page 78: Visual Inspection Dirt / Damage - Daily Before Training

     For full furfillment of the inspection report see MediTouch Annual Service Report with document number: DO-15-01-18 7.4 Visual inspection dirt / damage – daily before training  Carry out a general visual inspection to check for any damage to the device and support system.

  • Page 79: Wearable Sensors

    8 Wearable sensors Wearable MediTouch motion feedback devices can be worn during static and dynamic balance training in order to provide feedback on the user’s body part positions and instructions on the correct positioning and movement of body parts. The feedback also provides additional motivation to take part and complete the exercise task.

  • Page 80: Troubleshooting

    Very strong sources of interference (e.g. above the limit according to EMT) can influence the functions of the device. www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 81: Technical Specifications

    High-tension power lines nearby and electrical devices without - sign and without a certificate of compliance for electro-magnetic-tolerance should be avoided as well. 10 Technical specifications Product technical specification file could be found under the following MediTouch document part number: DO-15-01-01 www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel.

  • Page 82: Certificates

    11 Certificates 11.1 ISO 9001 Certificate of the SII (The Standards Institution of Israel) and the IQNET (The International Certification Network) according to ISO 9001-2015: www.meditouch.co.il Tel: (972)-9-8637477 45 Hamelacha, Poleg industrial zone, Netanya, Israel. info@meditouch.co.il Fax: (972)-9-8852935 Zip: 42505, PO Box: 8306 Page 82 of 85 BalanceTutor user manual 200824.doc...

  • Page 83: Iso 13485

    Certification Network) according to ISO 13485-2016: 11.3 Certificate of compliance medical devices Certificate of Compliance for devices for medical and rehabilitation purposes  Manufacturer Name: MediTouch Ltd. Tel: +972 9 8637477 Fax: +972 9 8852935 Address: 45 Hamelacha, Poleg industrial zone, Netanya 42505, Israel.
  • Page 84  EN ISO 13485:2016  IEC-601-60601-1, B3 This certificate of compliance covers the BalanceTutor which is produced by MediTouch. The validity of this certificate of compliance expires on the release date of a certificate of compliance with a later issue date, which may be necessary due to technical modifications or due to changes of standards, guidelines and directives.

  • Page 85: Disposal

    12 Disposal By request and at the expense of the client MediTouch might take over the disposal of old devices and devices no longer functioning. Please contact info@meditouch.co.il for a detailed offer. Note the information for possible disposal of the BalanceTutor system parts or components through the client or a subcontractor.

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