MediTouch BalanceTutor BT100 Скачать руководство пользователя страница 4

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www.meditouch.co.il

[email protected]

Tel: (972)-9-8637477

Fax: (972)-9-8852935

45 Hamelacha, Poleg industrial zone, Netanya, Israel.

Zip: 42505, PO Box: 8306

DO-15-01-02

BalanceTutor user manual 200824.doc

Contents

User Responsibility

...............................................................................................................................................................

MediTouch Contact Information

.........................................................................................................................................

Device description

................................................................................................................................................................

Safety, Warnings, Precautions, Prohibitions

.................................................................................................... 9

1.1 Electric safety / safety classes

..................................................................................................................... 10

1.2 Patient and Therapist security according to IEC 601-1

................................................................................ 10

1.3 Connection of units installed outside medically utilized locations

...............................................................

1.4

Protection against the danger of electrical shocks

...................................................................................... 11

1.5 Environmental requirements

.......................................................................................................................

1.6 Economic life-time

....................................................................................................................................... 12

1.7 Labels, Locations, Interpretations

................................................................................................................

1.7.1 Name plate

......................................................................................................................................... 13

1.7.2 User manual labels

............................................................................................................................. 13

1.7.3

Warning labels

...................................................................................................................................

1.7.4 Safety standards, norms

.................................................................................................................... 15

1.7.5 The CE mark

.......................................................................................................................................

1.7.6 EMC Electromagnetic & Safety Compatibility

.................................................................................... 15

1.8 Intended use

–

Indications

...........................................................................................................................

1.8.1 Neuromuscular Rehabilitation

...........................................................................................................

1.8.2 Musculoskeletal Rehabilitation

.......................................................................................................... 16

1.8.3 Vestibular Rehabilitation

....................................................................................................................

1.8.4 Sport Training

..................................................................................................................................... 16

1.8.5

Aging

.................................................................................................................................................. 16

1.8.6 Special Care in Use

............................................................................................................................. 17

1.9 Forbidden use

–

Contraindications

..............................................................................................................

1.10 Clinical guidelines

........................................................................................................................................ 18

Installation & commissioning

........................................................................................................................ 22

2.1 Staff members

............................................................................................................................................. 22

Содержание BalanceTutor BT100

Страница 1: ...l Tel 972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc BalanceTutor User Manual July 2020 Balance...

Страница 2: ...compliant IEC 60601 1 2 compliant IPX 0 Date Change description Written by Ver 11 Feb 2016 Initial version Ziv K 160211 8 Nov 2017 Adding Wearable sensor usability 9 2 9 3 Update Platform load bearin...

Страница 3: ...ediTouch authorized representatives or by MediTouch Trained personnel The Product must not be altered without the prior written approval of the MediTouch Quality Assurance Department The user of this...

Страница 4: ...utilized locations 10 1 4 Protection against the danger of electrical shocks 11 1 5 Environmental requirements 11 1 6 Economic life time 12 1 7 Labels Locations Interpretations 12 1 7 1 Name plate 13...

Страница 5: ...27 3 3 Electrical installation 27 4 Instructions For Use 29 4 1 Iluminated system status indicators 29 4 2 Starting the BalanceTutor system 29 4 2 1 Installation Overview Checklist 29 4 2 2 Switching...

Страница 6: ...2 2 Sizes 68 5 2 3 Harness features 68 5 2 4 Trigger positioning lanyar 68 5 2 5 Harness setup 69 5 3 General advice for training 71 5 4 Training duration and frequency 71 5 5 Selecting training param...

Страница 7: ...Immediate maintenance 77 7 3 Regular inspections examinations 77 7 4 Visual inspection dirt damage daily before training 78 8 Wearable sensors 79 8 1 Setup IMU sensors 79 8 2 Setup Heart Rate monitor...

Страница 8: ...e 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 An innovative approach using wireless sensors...

Страница 9: ...of 2 meters away from any part of the system Don t use any system additional part accessory which has not been installed or checked by MediTouch BalanceTutor must only be used after equipment verific...

Страница 10: ...safety precautions with protective wiring and the safety class II i e safety measures without protective wiring but with double isolation Devices of the safety class I are devices where the metallic c...

Страница 11: ...ctric device to the earth end subject via the therapist doctor 1 5 Environmental requirements MediTouch systems are not to be used in medically utilized rooms with a danger of explosions or in easily...

Страница 12: ...s mechanical parts like for example deflection pulleys are renewed at damage or unusual heavy duty possibly earlier and the recommended maintenance intervals are kept Every maintenance and repair work...

Страница 13: ...r manual labels IMAGE MESSAGE Refer to instruction manual booklet Warning Hazard Safety precautions Pay attention to accompanying instructions Devices of the type BF Alternating current AC Bullet poin...

Страница 14: ...ation of the system Sitting Prohibited This label located on the moving platform and indicates to any person not sit on the platform Protective Earth Ground This label located near any physical connec...

Страница 15: ...l with reference to design and construction characteristics refer to the up to date valid versions at the time of manufacture The standards with date in this manual applying to routine measurements an...

Страница 16: ...hat the system can be indicated as follows 1 8 1 Neuromuscular Rehabilitation Stroke Head injury Spinal cord injury Multiple sclerosis Cerebral palsy Peripheral nerve injury 1 8 2 Musculoskeletal Reha...

Страница 17: ...quires special attention to ability and medical condition of patient However the following list highlights particular indications that require specific care in use according to relevant therapy protoc...

Страница 18: ...Severe vascular disorders of the lower limbs In general patients who have been ordered to remain in bed or immobile due to for instance osteomyelitis or other inflammatory infectious disorders The ab...

Страница 19: ...al Lateral Unexpected Perturbation Clinical effect Weight bearing through customized reactive response Proprioceptive and kinesthesis rehabilitation Target Ankle flexion rehabilitation Technique Forwa...

Страница 20: ...cs triggered perturbation Clinical effect Fast Co contraction of Agonist and Antagonist muscles of the limb in stance phase Fast Co ordination of Agonist and Antagonist muscles of the limb in swing ph...

Страница 21: ...ion while running Clinical effect Improvement of Automatic Postural adjustment Faster compensatory step Improvement of Recovery time Target Multi task training Technique Multi Direction perturbation C...

Страница 22: ...sistant On site Remote control 1 hour Institution system administrator Remotely Pre installation Technical training 2 hour Distributor qualified technician Hospital clinical staff On site Clinical tra...

Страница 23: ...ling the correct installation area for the BalanceTutor ITEM DESCRIPTION Power inlet 2 cases can be valid 1 Phase 230 Volt AC L N PE 50 60Hz 16A circuit breaker dedicated line 3 Phase 190 230 Volt AC...

Страница 24: ...hase 16A 2 Phase 16A Dedicated power line required ___ A Power and Network inlets Specify location on top of the schematics diagram DESCRIPTION OPTION mark your option Wall type Stone Sheetrock Wood O...

Страница 25: ...trial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 2 5 Installation procedure In order perform installation and to be familiar with the product s maintenan...

Страница 26: ...end it back to the manufacturer transportation is to be paid by the customer Often a recyclable transport tool or packaging or a transport fuse metal angle with screws is included in the extent of del...

Страница 27: ...ust 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...

Страница 28: ...external isolation transformer it required to be fixed to a wall and not be disconnected in any case Before installing the BalanceTutor system please compare the specifications on the nameplate concer...

Страница 29: ...apist s operation touch screen Touch screen Isolation transformer power ON light Frontal side of the isolation transformer 4 2 Starting the BalanceTutor system 4 2 1 Installation Overview Checklist As...

Страница 30: ...ne time on the button to turn ON the computer of the BalanceTutor and let the operation system complete its loading 03 Type Username admin Password admin 04 Perform perturbation platform calibration b...

Страница 31: ...the touch screen then press Shutdown The computer of the BalanceTutor will be shutdown 02 Press one time on the button to turn OFF the computer of the BalanceTutor 03 Turn the isulation transformer d...

Страница 32: ...Software Operation This section describes the operation of BalanceTutor software usage 4 3 1 Login Type your username and password to login into the software Username admin Password admin 4 3 2 Homing...

Страница 33: ...7 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 3 3 Patient List In this stage you can create new patients...

Страница 34: ...r enables five main applications for postural control and balance therapy Trigger Treatment A series of different approaches to trigger a perturbation Muscle Training A series of different perturbatio...

Страница 35: ...perturbations Protocol A utility to customize a series of predefined perturbation types 4 3 5 1 Manual Trigger The Manual Trigger mode is designed to allow the therapist full controlling of treatment...

Страница 36: ...such as phase of the gait direction of the perturbation Treatment time perturbation time interval perturbation sequence random or blook and belt direction movement Treatment The Treatment stage allow...

Страница 37: ...ment stage allows the therapist to follow the treatment process as well as to show or eliminate patient s feedbacks shown on his screen 4 3 5 4 Protocol The protocol mode is designed to build specific...

Страница 38: ...Press on New button to create a new protocol The therapist can build a list of different perturbations events and defined them as a single protocol as follows 1 Define protocol name 2 Define which tri...

Страница 39: ...4 doc Treatment The Treatment stage allows the therapist to follow the treatment process as well as to show or disappear the perturbation timing direction and Balance COP distribution to the patient 4...

Страница 40: ...mber of the perturbation per minute and the intensity of the perturbation It should be noted that the direction of the perturbation is automatically set Treatment The Treatment stage allows the therap...

Страница 41: ...king speed and record for 2min until evaluation finished Comment This evaluation is indicated for patient suffering form limited gait distance ability like less than 100 meters License This feature is...

Страница 42: ...ist chooses the stance position 2 Therapist chooses either left or right perturbation 3 Therapist sets perturbation amplitude 4 Thereapist instructs the patient to maintain the stance through the pert...

Страница 43: ...C Regaining of the natural body sway after perturbation Time Point 1 Start of the recording Time Point 2 Perturbation event Time Point 3 First overshoot of the COP peak following perturbation event T...

Страница 44: ...ance ability These powerful assessments allow the therapist to establish a baseline showing the patient s functional ability at a given time during Physical therapy This baseline measurement will allo...

Страница 45: ...nfo meditouch co il Tel 972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 3 8 1 Gait Analysis Si...

Страница 46: ...m A numerical measurement of how far the subject walks during a given time Step Length cm The distance between the point of initial contact of one foot and the point of initial contact of the opposit...

Страница 47: ...gait cycle The entire time that a foot is on the ground Swing of gait cycle The entire time that the foot is in the air Mean An average of a certain parameter COV Coefficient of Variation COV is the r...

Страница 48: ...uch co il info meditouch co il Tel 972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc Documentation...

Страница 49: ...meditouch co il Tel 972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 3 8 2 Standing Stability...

Страница 50: ...o meditouch co il Tel 972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 3 8 3 Postural Analysis...

Страница 51: ...f the postural unexpected perturbation It refers to how far the platform is moving during the fixed time of 300 ms It is scaled from 1 to 30 For instance intensity 10 means that the platform is moving...

Страница 52: ...42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 3 9 Session Log A session Log is an inquiry of Baseline changes and all Treatment conducted in patient s activity history 4 3 9 1 B...

Страница 53: ...972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 3 9 2 Treatments Treatments report can be gene...

Страница 54: ...6 DO 15 01 02 BalanceTutor user manual 200824 doc These report can be printed or saved as pdf files 4 3 10 COP The COP task have been desgined to facilitate repetitions of isolated weight shifting pra...

Страница 55: ...posterior and medial lateral weight shifting practice in any stance position Therapist instructions Choose stance position Calibrate the fruit jug to this start position Instruct patient to do anterio...

Страница 56: ...nt purpose To facilite anterior posterior and medial lateral weight shifting practice in any stance position Therapist instructions Choose stance position Choose medial lateral of anterior posterior t...

Страница 57: ...ftware can t be added to Active Directory or organizations Group Policy However internal users can be created managed and supervised within the application 4 4 1 Users There are two types of internal...

Страница 58: ...some organization there is a request to keep patients identity anonymous The system provides this option using the following steps 1 Access the application as Administrator 2 Press the Setting button...

Страница 59: ...O 15 01 02 BalanceTutor user manual 200824 doc 4 4 3 System Hardening The SSD Solid State Drive within the embedded computer of the BalanceTutor my can configured to be solidified There is an option s...

Страница 60: ...system provides an additional security option to automatically log off the last user following inactivity 4 5 Data Export The BalanceTutor software generates two kind of files PDF and CSV 4 5 1 PDF A...

Страница 61: ...61 of 85 www meditouch co il info meditouch co il Tel 972 9 8637477 Fax 972 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 20082...

Страница 62: ...ncetutor sensorlogs after each treatment or an evaluation The content is raw data of Sampled Time COP Sensors IMU s an option and Perturbation states Sample rate is 65 70 samples second In order to en...

Страница 63: ...45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc All CSV files can be extracted to a comfortable visual view using Matlab m file...

Страница 64: ...E DESCRIPTION SEVIRITY Wrong User Password at login Error The perturbation platform start with homing procedure Message An attempt of the system to start homming procedure but one of the following pre...

Страница 65: ...ceTutor user manual 200824 doc Different Evaluations will present similar messages that summarizes patient performances Message Different Treatments will present similar messages that summarizes devic...

Страница 66: ...72 9 8852935 45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 4 7 Version identifier Each version of the BalanceTutor software ha...

Страница 67: ...hat the BalanceTutor does before their first training session Make patients aware of the benefits and risks of training as well as the concept of perturbation 5 2 Safety harness The BalanceTutor comes...

Страница 68: ...Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 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 Fa...

Страница 69: ...dustrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 5 2 5 Harness setup STAGE 1 Harness level adjustment Adjust harness level to patient s height using t...

Страница 70: ...505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc STAGE 3 Buckle leg straps Buckle leg straps and adjust their length if required STAGE 4 Buckle chest straps Buckle chest straps STAGE 5...

Страница 71: ...patient is making during the course of treatment Current scientific knowledge about training stipulates as a requirement for maximum motor learning success that the organism has recovered as fully as...

Страница 72: ...rders Pull the plug out of the socket to separate the BalanceTutor from the current Is there a person or object inside the danger zone Stop the training session immediately and make sure that there is...

Страница 73: ...lking situation 6 1 Clinical Applications BalanceTutor enables Perturbation based Balance Training and Center of Pressure COP practicing to improve and retain postural control and balance ability by f...

Страница 74: ...sk needing proper physical and cognitive ability This task requires coordination of automatic body movement during the gait together with cognitive process like reading or thinking BalanceTutor allows...

Страница 75: ...leg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc Walking stability training using BalanceTutor can be achieved by practicing of computerized per...

Страница 76: ...ust also be carried out at shorter intervals 7 1 Preventive maintenance 7 1 1 Power entry to the device Before switching the device ON always check the circuit cable plug outlet socket and circuit ent...

Страница 77: ...use Fluid has got into the device Cable and or connector plug have been damaged Coverings and or safety warnings have fallen Off The rope or the deflection pulleys show sign of wear A defect or malfun...

Страница 78: ...e to the device and support system If any damage is suspected the BalanceTutor must not be used Clean any remains on the floor before turning ON the device Clean the therapist touch screen Check that...

Страница 79: ...ositioning and movement of body parts The feedback also provides additional motivation to take part and complete the exercise task 8 1 Setup IMU sensors Step Description Indication 1 Turn IMU sensor O...

Страница 80: ...e between the user and the device Electrostatic discharges can in certain cases result in interference of the device Generally those electrostatic discharges are without harm for the user as well as f...

Страница 81: ...306 DO 15 01 02 BalanceTutor user manual 200824 doc High tension power lines nearby and electrical devices without sign and without a certificate of compliance for electro magnetic tolerance should be...

Страница 82: ...45 Hamelacha Poleg industrial zone Netanya Israel Zip 42505 PO Box 8306 DO 15 01 02 BalanceTutor user manual 200824 doc 11 Certificates 11 1 ISO 9001 Certificate of the SII The Standards Institution...

Страница 83: ...stitution of Israel and the IQNET The International Certification Network according to ISO 13485 2016 11 3 Certificate of compliance medical devices Certificate of Compliance for devices for medical a...

Страница 84: ...mark gets affixed to the product The following listed and fulfilled norms are elements of our production EN 60601 1 EN 60601 2 EN ISO 9001 2015 EN ISO 13485 2016 IEC 601 60601 1 B3 This certificate of...

Страница 85: ...linked to the heavy metals concerned and the flame retardants concerned 12 1 Disassemble and cut up Use personal protective equipment when cutting up material of any kind with the appropriate tools ey...

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