MediTouch BalanceTutor BT100 User manual

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BalanceTutor™
User Manual
July 2020
BalanceTutor a dynamic and static postural control trainer

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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.
Type BF Medical Equipment
IEC 60601-1-1 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 bearing calculation
Ziv K.
171108
18 Jun 2018
Modification of (Special Care in Use)
Avraham C.
180618
03 Oct 2018
Modifications to comply with IEC60601-1 Ed 3.1
Ziv K.
181003
18 Feb 2020
Adding Gait Analysis evaluation
Ziv K.
200218
25 Feb 2020
Adding section: system security
Ziv K., Moshe D.
200225
22 Mar 2020
Evaluation reports parameters definitions
Avraham C.
200322
17 Jun 2020
Certificate update: ISO 9001:2015, ISO 13485:2016. Name plate EC rep details
Ziv K.
200617
24 Aug 2020
Adding postural analysis measures descriptions
Avraham C.
200824
E&EO

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User Responsibility
This Product will perform as described in this User Manual and by accompanying labels and/or
inserts, when it is assembled, operated, maintained and repaired in accordance with the instructions
provided. This Product must be checked periodically as described in this manual. A defective
product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated
should be replaced immediately. 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. The Product must
not be altered without the prior written approval of the MediTouch Quality Assurance Department.
The user of this Product shall bear the sole responsibility for any malfunction which results from
improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than an
MediTouch authorized representatives. Any unauthorized maintenance, repairs or equipment
modification activities may void the MediTouch product warranty.
MediTouch Contact Information
MediTouch welcomes your inquiries and comments. Professional staff, including physiologists,
physiotherapists, applications engineers, and customer support specialists are available to assist you
with any questions you may have regarding your BalanceTutor system.
MediTouch Headquarter
Address
45 Hamelacha street, Netanya 42505, Israel
Telephone
(972) 9 8637477
Fax
(972) 9 8652935
Website
www.meditouch.co.il
Service and Support
Address
45 Hamelacha street, Netanya 42505, Israel
Telephone
(972) 9 8637475
Fax
(972) 9 8652935
Email
[email protected]

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Contents
User Responsibility...............................................................................................................................................................3
MediTouch Contact Information .........................................................................................................................................3
Device description................................................................................................................................................................8
1Safety, 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 ...............................................................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
1.7.2 User manual labels .............................................................................................................................13
1.7.3 Warning labels ...................................................................................................................................14
1.7.4 Safety standards, norms ....................................................................................................................15
1.7.5 The CE mark .......................................................................................................................................15
1.7.6 EMC Electromagnetic & Safety Compatibility ....................................................................................15
1.8 Intended use –Indications ...........................................................................................................................16
1.8.1 Neuromuscular Rehabilitation ...........................................................................................................16
1.8.2 Musculoskeletal Rehabilitation ..........................................................................................................16
1.8.3 Vestibular Rehabilitation ....................................................................................................................16
1.8.4 Sport Training .....................................................................................................................................16
1.8.5 Aging ..................................................................................................................................................16
1.8.6 Special Care in Use .............................................................................................................................17
1.9 Forbidden use –Contraindications ..............................................................................................................18
1.10 Clinical guidelines ........................................................................................................................................18
2Installation & commissioning ........................................................................................................................22
2.1 Staff members .............................................................................................................................................22

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2.2 Staff members qualification ........................................................................................................................22
2.3 Device installation schematics .....................................................................................................................23
2.4 Installation preparation form ......................................................................................................................24
2.5 Installation procedure ..................................................................................................................................25
3 Transport, Unpacking & Packaging ................................................................................................................26
3.1 Transport to upper floors and through narrow doors .................................................................................26
3.2 Mechanical installation ...............................................................................................................................27
3.3 Electrical installation ...................................................................................................................................27
4Instructions 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 the device ON ....................................................................................................................30
4.2.3 Start working with patients ................................................................................................................30
4.2.4 Switching the device OFF ...................................................................................................................31
4.3 Software Operation .....................................................................................................................................32
4.3.1 Login ...................................................................................................................................................32
4.3.2 Homing stage .....................................................................................................................................32
4.3.3 Patient List .........................................................................................................................................33
4.3.4 Operational Modes ............................................................................................................................34
4.3.5 Trigger Treatment ..............................................................................................................................35
4.3.6 Muscle Training ..................................................................................................................................39
4.3.7 Evaluations .........................................................................................................................................40
4.3.8 Reports ...............................................................................................................................................43
4.3.9 Session Log .........................................................................................................................................52
4.3.10 COP .....................................................................................................................................................54
4.4 System Security ............................................................................................................................................57
4.4.1 Users ..................................................................................................................................................57
4.4.2 Anonymous Patient ............................................................................................................................58
4.4.3 System Hardening ..............................................................................................................................59
4.4.4 Automatic System Log Off ..................................................................................................................60
4.5 Data Export ..................................................................................................................................................60

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4.5.1 PDF .....................................................................................................................................................60
4.5.2 CSV .....................................................................................................................................................62
4.6 System messages .........................................................................................................................................64
4.7 Version identifier .........................................................................................................................................66
5Training ........................................................................................................................................................ 67
5.1 General notes ...............................................................................................................................................67
5.1.1 Suitable clothing .................................................................................................................................67
5.1.2 Before starting training ......................................................................................................................67
5.2 Safety harness ..............................................................................................................................................67
5.2.1 Putting on the harness .......................................................................................................................67
5.2.2 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 parameters .....................................................................................................................71
5.6 Training troubleshooting .............................................................................................................................72
5.7 Patient becomes unconscious ......................................................................................................................72
5.8 After training ...............................................................................................................................................72
5.9 At the end of a training day .........................................................................................................................72
6Clinical Guidelines .........................................................................................................................................73
6.1 Clinical Applications .....................................................................................................................................73
6.1.1 Weight-Bearing Encouragement ........................................................................................................73
6.1.2 Compensatory Step Respond .............................................................................................................73
6.1.3 Vestibular Rehabilitation ....................................................................................................................73
6.1.4 Muscle Activation ...............................................................................................................................74
6.1.5 Somatosensory System Training ........................................................................................................74
6.1.6 Multi-Task ..........................................................................................................................................74
6.1.7 Standing Stability ...............................................................................................................................74
6.1.8 Walking Stability ................................................................................................................................74

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7 Maintenance & Safety Inspections ................................................................................................................76
7.1 Preventive maintenance ..............................................................................................................................76
7.1.1 Power entry to the device ..................................................................................................................76
7.1.2 Treadmill belt set to the correct tension ...........................................................................................77
7.1.3 Perturbation plate centering ..............................................................................................................77
7.2 Immediate maintenance ..............................................................................................................................77
7.3 Regular inspections/examinations ..............................................................................................................77
7.4 Visual inspection dirt / damage –daily before training ...............................................................................78
8Wearable sensors .......................................................................................................................................... 79
8.1 Setup IMU sensors .......................................................................................................................................79
8.2 Setup Heart Rate monitor ............................................................................................................................79
9Troubleshooting ............................................................................................................................................80
9.1 Touch screen is not responding ...................................................................................................................80
9.2 Interference factor .......................................................................................................................................80
9.2.1 Mechanical .........................................................................................................................................80
9.2.2 Electrostatic Discharge .......................................................................................................................80
9.2.3 Source of Interference .......................................................................................................................80
10 Technical specifications ........................................................................................................................................81
11 Certificates ................................................................................................................................................... 82
11.1 ISO 9001 .............................................................................................................................................82
11.2 ISO 13485 ...........................................................................................................................................83
11.3 Certificate of compliance medical devices ...................................................................................................83
12 Disposal ........................................................................................................................................................ 85
12.1 Disassemble and cut up ...............................................................................................................................85
13 Appendix ................................................................................................................................................... 85
13.1 Instruction & Commissioning .......................................................................................................................85

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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.
An innovative approach using wireless sensors integrated in the BalanceTutor allows for the
provision of numerous kinds of controlled expected and unexpected perturbation. These kinds of
perturbation can be generated in relation to the specific phase of gait namely in stance or swing
phase in the gait cycle. In addition to controlled expected and unexpected perturbation in the
standing and gait, the device also allows for Center of Pressure control practicing.

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1 Safety, Warnings, Precautions, Prohibitions
Read the whole manual before use.
Consult a doctor before using this device.
Only one person at a time to use BalanceTutor.
Do not use walk aid devices like stick or walker with the device.
Use only with appropriate clothing and training shoes.
Incorrect and/or forbidden use and/or overtraining can lead to serious injury or even death.
If you feel close to fainting, the training has to be stopped immediately.
If you feel sick or dizzy, stop training immediately and consult a doctor.
Always warm up fully at walking speed before starting to run.
Any kind of BalanceTutor operation including patient treatment must be carried out by only
trained therapist/ doctor certified by MediTouch Company.
Use at own risk - the manufacturer is not liable for damage.
Anyone not involved in the training session must keep at least a safe distance 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 verification according to user manual.
Do not start or carry out training if abnormal operation detected. If an abnormal operation
occurs during a session stop the session immediately by the emergency stop switch or by the
software in the operators display panel.
Before start of any treatment on the BalanceTutor wear the safety harness on the patient and
confirm patient is secured, safe and ready to start a treatment or a session.
The BalanceTutor is approved for use with a maximum body weight of 135 kilograms.
Heavier patients must not be trained with the BalanceTutor.
Make sure, before releasing the user from the harness belt, the treadmill and the perturbation
mode are not active and no automatic software program is in progress.
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.
In the event of a power failure the user must be lowered using the emergency release. Do not
continue training until proper operation is guaranteed.

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The BalanceTutor system may only be used if maintenance has been carried out properly
according to the instructions included in this user manual.
Consulting, sales, installation, commissioning, instruction, inspections, maintenance and
service repair works only through trained and by MediTouch certified personnel.
1.1 Electric safety / safety classes
The BalanceTutor is a class Ⅰ ME equiepment (Medical Electrical). Therefore,
Background:
In order to protect the user and the personnel, the association of German electro technicians Inc, (VDE) has published
special directives for medical used rooms and electro-medical devices. Devices with a power supply therefore have to, in
order to prevent the passing on of the mains voltage over to touchable metal pieces, be equipped with not only a reliable
isolation of the parts being under voltage but also additional safety precautions.
The VDE-association divides it into so called safety classes. For electro-medical devices, licensed safety classes are
mainly used the safety class I (i.e. 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 casing-
parts are connected with the protective wire of the line net via the safety contact. In the case of an isolation error the
inserted fuse element switches off.
1.2 Patient and Therapist security according to IEC 601-1
At your BalanceTutor medical product the user is protected / isolated from the mains in accordance
with the safety standard referring to the requirements for leakage current values according to IEC
601-1. The connection of further mains-operated units to your BalanceTutor may cause that all the
leakage currents add and the safety of the patient is reduced. Due to this the connection of further
units may only be carried out on consultation with MediTouch.
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. Optical fiber or optocoupler (4kV checked and approved) or …
2. Protective isolation via insulation transformer according to IEC 601-1.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.

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These units are to be connected to the equipotent conductor. Due to the increased safety
requirements medical instruments may not be connected via extension leads or multi-way
connectors.
1.4 Protection against the danger of electrical shocks
Casing and cover: Parts of non-medical electric devices
within the surrounding of the subject, which, after
having taken off the coverings etc. without the use of
tools for a routine maintenance etc., are in touchable
reach, have to operate with a voltage that does not
exceed 25 volt alternate voltage and 60 volt direct
voltage, which is produced by a separate source as
described in IEC 601-1. According to this example the
leakage current would flow from the electric 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 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. High voltage lines must be avoided nearby the
device. MediTouch electrical devices with mains connections must neither be used in wet and humid
areas (e.g. swimming pool, sauna, etc.) nor in environmental chambers.
If not stated otherwise in the delivery information MediTouch devices are designed for operation in
normal climatic surroundings (DIN IEC 601-1):
Temperature: + 10° ... + 40° C
Relative humidity: 30 ... 70 % (non-condensing!)
Air pressure: < 1.5 bar (approx. 10,000 feet (3000m), without pressurization)
The system has to be protected from high humidity. Store the devices at a temperature of –20° ... +
50° C.
Electrical equipment [3] and a subject [1] must never be touched by the doctor or trainer [2]
at the same time.

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1.6 Economic life-time
The economic life time of the product is determined at common usage and application to 15 years,
provided that after 10 years all electrical parts and component, as well as 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 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. The labels provide safety information while
using the device for safe and enjoyable exercise experience. Should any of the labels become
damaged and unreadable, immediately contact MediTouch for replacements.

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1.7.1 Name plate
IMAGE
LOCATION
1.7.2 User 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 point
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

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1.7.3 Warning labels
IMAGE
MESSAGE
DESCRIPTION
LOCATION
Hand Crush/Moving Parts
This label is located on areas where
the moving platform slides below
the stationary metal cover that
present a pinch hazard. Hands or
any other part of the body should
not be placed in these areas during
operation 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
connection of ground wire to
chases. Normally this label located
within the device.
Internal ground
connection
Electrical
Shock/Electrocution
This label is located beside the
electrical entrance of the device
and indicates a high voltage is
present in that location. If you see
this label, do not get close to or
disassemble any of the components
to which it is attached. The high
voltage can cause serious injury or
death. Only a qualified MediTouch
Service Technician should attempt
any repairs in these areas.

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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. The country-specific requirements must be compared before initial operation. Operate
BalanceTutor system only, if the requirements correspond. Full list of applicable norms see also in
the CE-certificate of compliance.
The standards with date in this manual 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 and continual safety
relevant measures (e.g. electrical measurements to determine leakage current, insulation resistances
etc.) can and will change with time. Therefore the up to date valid versions of the respective
standards at the time of measurement and their limit values, which can deviate then from the
procedures and limit values in this manual, apply.
1.7.5 The CE mark
The mark on the nameplate of the device confirms the compliance to the council directive
89/336/EEC appendix I (EMC electromagnetic compatibility).
1.7.6 EMC Electromagnetic & Safety Compatibility
The BalanceTutor system for medical applications has been built corresponding to the European
Union Council Directive 93/42/EEC Norms: EMC: EN60601-1-2, Safety: EN60601-1 Ed 3.1
Certification bodies: ITL –Israel Testing Laboratories.

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1.8 Intended use –Indications
BalanceTutor can be used in Neuromuscular, Musculoskeletal rehabilitation, vestibular
rehabilitation, sport training and fall prevention in geriatric field. There are varieties of medical
indications that 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 Rehabilitation
Joint surgery / fracture
Amputation
Muscle weakness
Prosthetic
Muscle / tendon strain
Ligament strain
1.8.3 Vestibular Rehabilitation
Dizziness, vertigo and equilibrium therapy
1.8.4 Sport Training
Rehabilitation after sport injury
Athletes training
1.8.5 Aging
Fall prevention
ADL activities improvement
Consult a qualified doctor before using this device. The physician in charge is always responsible for
indicating the training.

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1.8.6 Special Care in Use
In general, any kind of training by the device requires 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 protocols and must be with the approval of a qualified
physician/ doctor recommendation.
!Joint instability following surgery or trauma.
!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

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1.9 Forbidden use –Contraindications
Any kind of medical problems including cardiovascular, mental or physical impairment leading to an
inability to use the system are contraindicated for using of the device. The following
contraindications must be taken into account before using of the BalanceTutor:
Patients who are not able to stand or walk without walk aid devices or external assistance.
Body weight greater than 135 kg
Severely fixed contractures
Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)
Open skin lesions in the area of the lower limbs and torso
Unstable circulation
Cardiac (blood) contraindications
Uncooperative or (self) aggressive behavior, such as transitory psychotic syndrome
Severe cognitive deficits
Patients with (long-term) infusions
Mechanical ventilation
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 above list does not claim to be exhaustive. The decision as to whether a patient is suitable for
treatment always comes under the remit of the physician in charge, who has sole medical
responsibility for the treatment. As part of this, he must evaluate in particular, in each individual
case, possible risks and side-effects of the treatment against the benefit gained from it. In addition,
the patient’s individual situation plays just as important a role as the basic risk assessment for
specific patient groups.
Being a scientific discipline, medicine is subject to constant change in response to new knowledge
and progress. It is therefore the task of the physician in charge to continually keep his knowledge up
to date by reading the latest scientific literature and to acquire new knowledge during the course of
treatment.
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

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DO-15-01-02
BalanceTutor user manual 200824.doc
unplanned COM passive movement. This reactive postural response is intended to stabilize the COM
over the Base of Support by returning it back to initial position or to create new safe BOS for COM
using a compensatory step. In these two cases the body tries to move actively to opposite direction of
the applied perturbation.
There are several guidelines based the above concept how to formulate the appropriate perturbation
according to rehabilitation aims as follows.
Target: Weight bearing encouragement
Technique: Medial /Lateral Unexpected Perturbation
Clinical effect:
Weight bearing through customized reactive response
Proprioceptive and kinesthesis rehabilitation
Target: Ankle flexion rehabilitation
Technique: Forward to Backward unexpected Perturbation
Clinical effect:
Fast and highly intensive activation of Gastrocnemius and Soleus muscles
Unique technique for Forefoot weight bearing
High level coordination of ankle agonist and antagonist muscle activation
Unique facilitation of gait initiation
Target: Ankle extension rehabilitation
Technique: Backward to Forward Unexpected Perturbation
Clinical effect:
Fast and highly intensive activation of ankle extensors muscles
Unique technique for Rearfoot weight bearing
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

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DO-15-01-02
BalanceTutor user manual 200824.doc
Static and Dynamic ankle joint stabilization
High resolution of Proprioceptive and Kinesthesis activation
Target: ACL rehabilitation
Technique: Forward to Backward Unexpected Perturbation
Clinical effect:
Fast and Highly Intensive activation of Knee muscles
Use of ACL Proprioceptive and Kinesthesis abilities at maximum capacity
Accurate and Fast Quadriceps and Hamstrings Coordination
Target: Neuromuscular coordination training
Technique: Kinetics and kinematics 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 phase
Customized open- loop and closed-loop neuromuscular control
Target: Groin strain rehabilitation
Technique: Accelerated Perturbation while walking sideways
Clinical effect:
Controlled contraction and stretching of the hip adductors
Target: Hip flexion rehabilitation
Technique: Forward to Backward Perturbation while standing and walking
Clinical effect:
Unique technique for stretching of Iliopsoas in stance phase
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