Tyromotion Myro User manual

MYRO®
GEBRAUCHSANWEISUNG / USER MANUAL
Sprachen: Deutsch (DE) - Originalsprache, Ausgabedatum der Gebrauchsanweisung: 04.01.2017
Languages: English (EN), Issue Date of User Manual 4. January 2017

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Contact information:
Manufacturer:
TYROMOTION GmbH
Bahnhofgürtel 59
8020 Graz
AUSTRIA
TEL [phone]
FAX [phone]
MAIL [e-mail]
WEB www.tyromotion.com
SUPPORT [e-mail]
Distributor:
TYROMOTION GmbH
Bahnhofgürtel 59
8020 Graz
AUSTRIA
TEL [phone]
FAX [phone]
MAIL [e-mail]
WEB www.tyromotion.com
SUPPORT [e-mail]

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Table of contents
Introduction 5
1.1 Introduction 5
1.1.1 Regarding the usage of this documentation 5
1.1.2 Symbols in the user manual 5
1.1.3 System content 5
1.1.4 The therapy system 6
1.1.5 Intended purpose 7
1.1.6 Notices 7
1.1.7 Safety 8
1.1.8 Warnings 8
1.1.9 Owner's responsibility 12
1.1.10 Errors and omissions 12
1.1.11 Property of TYROMOTION GmbH 12
1.1.12 Warranty and legal disclaimer 12
1.2 Training concept 14
1.3 Symbols on MYRO® 14
1.3.1 Type label 16
Technology 17
2.1 Technology 17
2.1.1 Overview 17
2.1.2 Area of application 18
2.2 The MYRO® system 20
2.2.1 Power supply MYRO® 22
2.2.2 Installation 22
2.2.3 Repair 23
2.2.4 Disposal 23
2.3 Adjustment options MYRO ® 23
2.3.1 Height adjustment MYRO® 24
2.3.2 Referencing the MYRO® lifting columns 25
2.3.3 Tilt adjustment MYRO® 25
2.3.4 System/Headphones volume control 26
2.4 Device setup and movement 26
2.5 Monthly functionality check / Recurring check 27
2.5.1 Check list functionality test 27
2.5.2 Recurring checks 28
Clinical application 29
3.1 Indications/Contraindications 29
3.2 Safety 31

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3.2.1 Safety concept 31
3.2.2 Residual risk 32
3.3 Prior to training 32
3.3.1 Activating the MYRO® system 32
3.4 Performing training 32
3.4.1 Patient information 33
3.5 After training 33
3.5.1 Deactivating the MYRO® system 33
3.5.2 Cleaning the MYRO® system and associated parts 33

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Introduction
1.1 Introduction
We are happy to provide this user manual as an introduction for the usage of the MYRO®
therapy system. The following user manual addresses the essential functions that are
necessary for understanding the functionality and usage of MYRO®.
1.1.1 Regarding the usage of this documentation
It is absolutely imperative that every user completes the training course
and has read the user manual prior to using MYRO®!
For legibility reasons, the following pages only refer to the male gender, which, however,
always implies the female gender as well. TYROMOTION GmbH rejects any liability for
damages to persons or material if safety regulations and instructions relevant to the
usage of the MYRO® system are not observed!
1.1.2 Symbols in the user manual
Warnings: Severe risk of injury or hazard results when this symbol is
displayed in the user manual and notices are not observed. Be especially
mindful of these notices!
Follow the user manual.
1.1.3 System content
The MYRO® system consists of the following components, included in the delivery:
•Table frame consisting of foot stabilizers with castors, lifting column (including
controls), table top, storage container, 3 transport restraints, 3 covers for the
transport restraint openings, control cabinet with integrated PC and screen
•Mouse, mouse pad and keyboard
•USB-Stick (Quickstart Guide, User Manual, SetUp, Software)
•Power plug
•Headphone jack adapter (from 6.3 mm to 3.5 mm)
•MYRO® objects

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•Coin
•Ball
•Cup
•Handle
•Empty platform for individual objects
•Suction cup for traction and/or pressure applications
Accessories or spare parts such as MYRO® objects can be obtained directly from the
manufacturer.
Only use original accessories from the manufacturer.
Only the supplied suction cup may be used for traction and pressure
applications due to safety considerations.
1.1.4 The therapy system
MYRO® is a therapy table that, for the first time, allows the therapeutic usage of real
objects, swinging exercises as preparation for graphical-motor training and spatial-
explorative elements in a motivating and task-oriented manner.
The selected technology makes it possible to concurrently detect several points of
contact or objects, which provides the advantage of interactive and intuitive controls and
therapy without additional media and thus, by and large, barrier-free accessibility. Daily
movements can be trained and motor skills gradually re-learned with this therapy-
supporting device. All processes are recorded statistically and can be utilised for later
documentations and assessments.

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Image 1: Symbol photo MYRO® therapy system
1.1.5 Intended purpose
The MYRO® therapy system is generally used for neurological rehabilitation of the upper
extremities. The target group not only includes neurological, but also orthopedic and
pediatric patients. Depending on national variances, the MYRO® system is typically used
in ergotherapy and/or physiotherapy as therapeutic support, enhancement and
intensification in addition to conventional therapy forms. Repetitive active exercise and
training promotes the neuronal plasticity and thus the alteration (adaptation) of
synapses, nerve cells or even entire cerebral areas for the purpose of regaining lost
functionality.
1.1.6 Notices
Familiarize yourself with the user manual prior to system usage and re-
read the manual in regular intervals.
System users are also required to read the provided user manual for the
tyroS software and the accompanying papers!
Medical personnel and properly trained therapists responsible for the MYRO® system
are required to admonish technicians, patients and other persons within the vicinity of
the device to fully observe the contained safety precautions. The system may only be
operated by properly trained personnel. Training can be requested as required. Ensure
that the system is not manipulated by unauthorized personnel. The system is unpacked

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and installed by service personnel authorized by TYROMOTION GmbH. Never attempt to
install the system by yourself.
1.1.7 Safety
The MYRO® therapy system must be activated by persons who have read and
understood chapter 1.1.7 and 1.1.8. Modifications by users can compromise safety and
system performance. All modifications must be performed by persons certified by
TYROMOTION. The information in section 1.1.8.familiarizes users with potential hazards
of system usage and warns about injuries and damages resulting from non-observance
of safety precautions. Users are obligated to familiarize themselves with these safety
instructions and avoid conditions that may lead to injuries or damages.
1.1.8 Warnings
Warnings are always identified in the user manual by the symbol displayed in chapter
1.1.2 (yellow triangle with exclamation mark).
All warnings from the chapters are collectively stated in the following in order to ensure
the applicability of this user manual.
Warnings from chapter 1
Initial usage:
It is absolutely imperative that every user completes the training course and has read the
user manual prior to using MYRO®!
Accessory:
Only use original accessories from the manufacturer.
Only the supplied suction cup may be used for traction and pressure applications due to
safety considerations.
Warnings from chapter 2
Electromagnetic compatibility:
MYRO® is classified as a medical electronic device and therefore subject to specific
precautionary measures relating to electromagnetic compatibility (EMC). It is absolutely
imperative to observe the following EMC indications. Portable and mobile HF
communication equipment may affect MYRO®.
COMMENT: Administrations may also permit the setup and operation of class A devices
–with all necessary measures –in residential areas and facilities that are directly

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connected to the PUBLIC POWER GRID despite the fact that class A threshold values are
derived for industrial and commercial service rooms.
Consumption of food or beverages:
It is not permitted to consume or set down food or beverages near or on the device due
to safety considerations.
Liquids:
It is not permitted to set down liquids (for example, disinfectants) near or on the device
due to safety considerations.
Load capacity:
Caution: The therapy table is not designed to support a person who is standing or sitting
on it. The maximum load for the MYRO® application part is 60kg. The indicated load limit
only applies to the application part (device part that necessarily comes into physical
contact with the patient during proper usage so the device can function).
Power supply MYRO®:
The system may only be connected to a safety outlet as such an outlet provides the
necessary protection.
The system may only be connected to electric IT circuits equipped with max. 30mA RCCB
protection.
The system may not be connected to the electric circuit with extension cables.
A USB port is provided at the control cabinet. Connecting peripheral devices (printer, etc.)
is not permitted.
Touching electrically live parts:
Some system parts may conduct electricity. The operator may NOT concurrently touch
the patient and any of these parts. The patient may also not touch these parts directly.
This applies to the following components:
•Lifting cylinder of the linear drive for the tilt adjustment of the table
Repair:
Always contact the manufacturer for repairs!

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Safety instructions - MYRO® adjustment:
Body parts may be pinched when lowering the lifting column or tipping the table. Ensure
that no body parts of yours, the patient or a third person are close to the tipping
mechanism while tipping the device.
Observe the notices attached to the device: "Warning crushing hazard" and "No entry".
Ensure that no objects are located on MYRO® when adjusting the height or tilt of the
system as these objects may fall.
The MYRO® control panel must only be operated by therapists.
Height adjustment MYRO®:
The height adjustment must always be performed while taking space requirements and
the patient's range of motion into account.
Adjust the height of the system to ensure optimal operation during therapy. The therapist
is responsible for making this adjustment.
Lowering the lifting column: It is possible to pinch body parts under MYRO® while lowering
the lifting column. Observe the warnings attached to the device! Only therapists may
lower the lifting column.
Tilt adjustment MYRO®:
The tilt adjustment must always be performed while taking space requirements and the
patient's range of motion into account.
Tilt of the therapy table: It is possible to pinch body parts while adjusting the tilt of the
therapy table. Observe the warnings attached to the device! Only therapists may adjust
the tilt of the therapy table.
System/Headphones volume control:
Make sure that the volume level is appropriate when using headphones in order to avoid
hearing damage and check the volume before use on patient.
Tipping hazard while moving the device:
It is imperative that the following items are observed due to the increased tipping hazard:
•Never move the device while a patient is close by.
•Always move the MYRO® therapy system in the collapsed mode (tabletop not tilted,
lowest position).
•Exercise caution while crossing thresholds.
•Observe the warning "Sitting prohibited", which is attached to the device.

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Monthly functionality check:
Immediately cease using the system if one of the malfunctions described in chapter 2.5.1
occurs or is suspected.
Warnings from chapter 3
Suitability of the system for the envisaged therapy:
•Consistent evaluation of the patient's therapy results
•Discontinuation of therapy in case of disproportionate deterioration of the patient's
condition.
Safety concept –Clinical application:
Never use objects made of glass, ceramics, metal or sharp, pointy, hot objects or liquids
that may injure the user/patient or damage the MYRO® therapy system.
The responsible therapist must assess whether and for how long the patient should
perform therapeutic work independently before starting the therapy. Cognitive abilities
and the general condition of the patient’s health must be taken into consideration.
Therapy must be interrupted if the therapist is unable to either see or hear the patient.
Therapy with cognitively impaired children or patients requires constant supervision by
the therapist.
Individual objects must not be used for patients under 3 years of age, as these constitute
a swallowing and injury hazard.
Performing the therapy while standing increases the falling risk and requires constant
supervision by the therapist.
Patients who are unable to keep their upper body in an upright position by themselves
require sitting supports to secure them in a seated position that is suitable for the
respective therapy.
Please also observe the user manual for the tyroS software.
Performing training:
Please always observe the tyroS software user manual throughout the entire training.

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Only trained personnel may be near the patient and therapy system during therapy.
Therapy personnel are ideally located beside the patient during therapy by the control
panel in order to give instructions and quickly activate the emergency shutdown in case
of emergency!
Cleaning the MYRO® system (see chapter 3.5.2):
Mandatory, standardized disinfection measures:
•Disinfection of MYRO® objects after therapy
•Disinfection of the MYRO® control surface after therapy
1.1.9 Owner's responsibility
The owner is responsible for ensuring that all persons who operate the system have read
and understood this user manual. However, we cannot guarantee that every person who
has read this manual is qualified to operate, inspect, check, calibrate, repair or modify
the system or fix system errors. The owner must ensure that the installation,
maintenance, calibration and repair of the system as well as the fixing of errors are only
performed by properly trained and fully qualified personnel. The owner of the MYRO®
therapy system must ensure that only properly trained and fully qualified personnel
(certified users or operators) receive the authorization to operate the system. It must be
ensured that the user has read and fully understood the operating instructions contained
in this user manual and has been trained either by TYROMOTION or by other employees
of the owner who have been trained by TYROMOTION before being authorized to
operate the MYRO® system. The owner is obligated to maintain a list of authorized
operators. The operator must contact TYROMOTION if the system does not work
properly or does not respond correctly to the commands described in this user manual.
1.1.10 Errors and omissions
Please contact TYROMOTION GmbH if this user manual contains errors or omissions
(addresses are listed at the beginning of the document and on our website
www.tyromotion.com).
1.1.11 Property of TYROMOTION GmbH
TYROMOTION GmbH owns the copyright-protected content of this user manual,
including all figures and illustrations; this information is exclusively provided for
operational, maintenance and repair purposes. Any distribution for other purposes or
copying without prior written approval by TYROMOTION is prohibited.
1.1.12 Warranty and legal disclaimer
TYROMOTION GmbH issues a warranty to the original system purchaser that the system
shall be free of material and qualitative processing defects for a period of 12 months

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under normal usage conditions from the date of installation on the owner's premises and
that the system complies with the mechanical and electrical specifications published by
TYROMOTION (unless the warranty term is extended by an optional service contract).
This warranty is granted under the provision that the system is installed, operated and
maintained in accordance with the user manual. The customer must submit all warranty
claims to TYROMOTION in written form within 60 days of the occurrence of the problem
and before the expiry of the warranty. TYROMOTION is exclusively obligated to repair,
exchange or correct faulty or non-compliant parts at its own discretion in accordance
with the warranty. TYROMOTION has no further obligations to the owner in regard to
these parts after the repair or exchange of faulty or non-compliant parts. All repairs or
maintenance work must be performed by an authorized TYROMOTION service
representative in accordance with this warranty. The above mentioned warranty
becomes null and void if repairs, maintenance or other work is performed by third
parties. Moreover, problems resulting from accidents, improper use, incorrect
application, storage damage, negligence as well as system or component modifications
are excluded from the warranty.
The above mentioned warranty is granted in place of all other warranties, rights or
conditions, and the system is delivered "without deficiency warranty" apart from the
limited warranty. TYROMOTION and its third-party suppliers specifically and
unreservedly reject all other explicit or implicit warranties held by the owner, his
personnel and patients, customers, users and any third parties, unreservedly including
all warranties for marketability, applicability for a specific purpose, non-infringement and
any warranties resulting from performance development, business trends or commercial
customs. TYROMOTION and its third-party suppliers do not provide declarations or
warranties for system compliance with the owner's requirements or for functionality
without interruption, errors or deficiencies.
TYROMOTION is in no way liable for indirect, incidental, specific or consequential
damage or for punitive damage compensation including, among other things, the loss or
absence of profits, yield, goodwill or usage, which the owner or third parties may incur
or for damage to connected equipment, costs for replacement products, installations,
servicing, exchange elements or idle time or for claims from patients, customers, visitors,
the owner's employees or other persons, regardless whether submitted within the
context of a contractual claim, due to unauthorized behavior, strict liability or imposed
by law or otherwise even when TYROMOTION has been informed about the possibility
of such damages. TYROMOTION's liability for damages resulting from or in connection
with this contract may not in any event exceed the purchasing price of the system.
Some jurisdictions limit or exclude the extent of restrictions, the exclusion of legal
means, compensation or liability, such as liability for gross negligence or willful
misconduct according to or in the abovementioned extent or do not permit the exclusion
of implicit warranties. In such jurisdictions, the restriction or exclusion of warranties,
legal means, compensations or liabilities described above may not be valid for the owner.

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Such restrictions or exclusions apply according to the highest legally permitted extent
even if they are not valid according to the legally prohibited extent. The owner may also
have other rights that vary depending on the specific country or other jurisdictions.
1.2 Training concept
The MYRO® therapy system is a complex technical device. Users of the MYRO® system
are required to complete a training course and read the user manual in order to ensure
the safety of patients, users and the device itself. Merely reading the present manual
does not convey sufficient competence for operating MYRO®. Prospective users are also
required to have basic medical training (e.g. physiotherapy/ergotherapy). TYROMOTION
GmbH rejects all liability for damages resulting from therapy that was performed by an
untrained user. Prospective users are trained after delivery of the MYRO® therapy
system.
Users are able to perform initial and repeated therapies training with MYRO®. Users are
not permitted to instruct other persons in the usage of MYRO®. Users are trained by a
member of TYROMOTION GmbH or by another trainer delegated by TYROMOTION
GmbH.
1.3 Symbols on MYRO®
STOP
Emergency shutdown button for interrupting the power supply to the actuators
(lifting column, lifting cylinder of the linear drive for adjusting the tilt of the
table)
Do not discard with household waste.
Application part, type B
Alternating current
CE mark

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Information about the manufacturer of MYRO®, including the manufacturer's
full mailing address is displayed next to the factory symbol.
Follow the user manual.
Warning symbol: Tipping hazard while pushing the device
The symbol warns users that the device may tip when moved. Keep this in mind
when moving the device.
Warning symbol: Crushing hazard warning
IP20
Protection class against penetration of foreign bodies and water: 2 means
protection against penetration of solid bodies ≥ 12.5 mm Ø. 0 means NO
protection against water penetration.
No entry!
Entering the area is prohibited due to potential pinch point and breakage
hazard.
Sitting prohibited!
Sitting on or bracing oneself against the device or device parts is prohibited.
Labelling on the power switch:
I means the device is activated (top position, switch lights up green).
O means the device is deactivated (bottom position).

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MYRO® activation button
1.3.1 Type label
Image 2: Type label MYRO®
The type label designates MYRO® as a medical product.

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Technology
2.1 Technology
2.1.1 Overview
Type designation:
MYRO®
Build year:
Can also be determined from the serial number, e.g. SN: MR1-2016 –XXX
refers to the year 2016.
Classification:
The MYRO® system is an active, therapeutic class I medical product according
to regulation 1 and 12 of the Council's Directive 93/42/EEC, appendix IX and
the current supplement 2007/47/EC.
Type of application part:
Type B
Protection against electric
shock:
Protection class I device –protective grounding
Electromagnetic
compatibility:
Class A device (CISPR 11) The MYRO® system is suitable for usage in all other
facilities apart from apartments and residential dwellings that are directly
connected to the PUBLIC POWER GRID that supplies the building. EN60601-
1-2:2001, requirements have been fulfilled.
Country of origin:
Austria
Power supply voltage:
110 –240V alternating current
Supply frequency:
50/60Hz
Electricity/Power
consumption:
5 –2,5A / 540W
Supply grid:
Only connect to supply grids with protective ground wiring.
Operating type:
Continuous operation
Electrical adjustment drives interval operation (2 min. on/18 min. off)
Fuses:
Secured for all poles (2x T6, 3A L 250V)
Power supply voltage:
Drives:
12/24V DC
Max. tipping speed:
13-16 mm/second
Max. drive power:
500N pushing/pulling
Measurement range:
pressure (table horizontal): screen center 0 –300N
pressure (table vertical): screen center 0 –200N
traction (table horizontal or vertical): screen center 0 –50N
Measurement deviation
strength assessment:
< ±5%
Weight:
110kg

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Dimensions (WxLxH)
Collapsed (in mm): 1504 x 890 x 703
Extended (in mm): 1504 x 890 x 1363
Max. height in extended and tipped state (in mm): 1730
Penetration protection:
IP20
MYRO® is classified as a medical electronic device and therefore subject to
specific precautionary measures relating to electromagnetic compatibility
(EMC). It is absolutely imperative to observe the following EMC indications.
Portable and mobile HF communication equipment may affect MYRO®.
Guidelines and manufacturer's declaration –ELECTROMAGNETIC EMISSIONS
The MYRO® system is exclusively designed for operation in an ELECTROMAGNETIC ENVIRONMENT as
indicated below. The customer or user of the MYRO® therapy system must ensure that it is used in such an
environment.
Interference emission
measurements
Compliance
ELECTROMAGNETIC
ENVIRONMENT –
Guidelines
HF emissions according to CISPR
11
Group 1
Class A
MYRO® system exclusively uses HF
energy for internal functionality.
Therefore, HF emissions are very
low and unlikely to disrupt
electronic devices within range.
Harmonics emissions according
to IEC 61000-3-2
Class A
The MYRO® therapy system is
suitable for usage in all other
facilities apart from apartments
and residential dwellings that are
directly connected to the public
power grid that supplies the
building.
Voltage fluctuations/flicker
emissions according to IEC
61000-3-3
Not applicable
COMMENT: Administrations may also permit the setup and operation of
class A devices –with all necessary measures –in residential areas and
facilities that are directly connected to the PUBLIC POWER GRID despite
the fact that the threshold values for class A are derived for industrial and
commercial service rooms.
2.1.2 Area of application
Device usage is principally limited to clean, dry rooms within professional health care
establishments.

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Operation:
Temperature: 10 ... 30 °C
Humidity: 30 ... 75 % relative humidity
Storage and transport:
Temperature: -20 ... 60 °C
Humidity: 20 ... 90 % relative humidity, no dew
Caution:
The MYRO® therapy system may not be used in explosion-prone zones AP and APG
according to EN 60601-1/2006.
Among other things, this means:
The usage of easily flammable and explosive, anesthetic inhalation materials and
mixtures thereof is not permitted within the vicinity of the MYRO® therapy system. These
materials include:
•Ether pro narcosi (diethyl ether)
•Cyclopropane
It is not permitted to consume or set down food or beverages near or on
the device due to safety considerations.
It is not permitted to set down liquids (for example, disinfectants) near or
on the device due to safety considerations.
Caution: The therapy table is not designed to support a person who is
standing or sitting on it. The maximum load for the MYRO® application
part is 60 kg. The indicated load limit only applies to the application part
(device part that necessarily comes into physical contact with the patient
during proper usage so the device can function).

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2.2 The MYRO® system
Bild 3
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