Reha Technology Armotion User manual

Armotion™
User Manual

1 Introduction ................................................................................... 1
1.1 About the User Manual ............................................................................................... 1
1.2 Explanation of Symbols ............................................................................................... 2
1.3 Warranty and Liability ................................................................................................. 3
1.4 opyright Protection ................................................................................................... 4
2 The Armotion™ ............................................................................... 5
2.1 General ........................................................................................................................ 5
2.2 Manufacturing and Optimization ................................................................................ 6
2.3 Type Label ................................................................................................................... 6
3 Safety Instructions .......................................................................... 7
3.1 Intended Use ............................................................................................................... 7
3.2 ontraindications ........................................................................................................ 8
3.2.1 General contraindications .................................................................................... 8
3.2.2 Spasticity management ........................................................................................ 9
3.3 General Hazards ........................................................................................................ 10
3.4 Personnel Qualification ............................................................................................. 10
4 S ecifications ............................................................................... 11
4.1 Specifications in Detail .............................................................................................. 11
4.2 Operating onditions ................................................................................................ 11
4.3 F compliance ......................................................................................................... 12
5 Com onents ................................................................................. 13
5.1 Overview ................................................................................................................... 13
6 O eration of Armotion ................................................................. 20
6.1 Switching on the Armotion ....................................................................................... 20
6.2 Starting the Armotion ............................................................................................... 21
7 The Armotion Software ................................................................ 23
7.1 Starting the Software ................................................................................................ 23
7.2 Navigation in ARMOTION Software .......................................................................... 24
7.3 Patient File ................................................................................................................. 25
7.4 Exercises .................................................................................................................... 28
7.4.1 Parameters common to all exercises ................................................................. 29
7.4.1.1 Auto mode: passive therapy option ........................................................... 29

7.4.1.2 Normal Mode: active assistive therapy option .......................................... 29
7.4.2 Exercise “Tracks” ................................................................................................ 30
7.4.3 Exercise “ oins” ................................................................................................. 34
7.4.4 Exercise “ ar racing” .......................................................................................... 36
7.4.5 Exercise “Memory” ............................................................................................ 37
7.4.6 Exercise “Dish Washing” .................................................................................... 39
7.4.7 Scoring and results ............................................................................................. 41
8 Maintenance ................................................................................ 47
8.1 leaning the Armotion .............................................................................................. 47
8.2 Annual Maintenance heck ...................................................................................... 48
9 Dis osal ........................................................................................ 48

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1Introduction
1.1 About the User Manual
The manual contains all the information necessary in order to ensure the safe use of the
Armotion. This manual is intended for the use of the software version 1.2 and its subversions. In
case there are software updates performed new user manuals are distributed if required.
The manual is intended for medical and therapeutic personnel. Practical knowledge of medical
processes and applications as well as the technical terms used for the execution of this type of
therapy are a prerequisite to operating personnel.
Trained and qualified medical personnel and therapists who are responsible for the Armotion are
obliged to ensure that technicians, patients and other persons who are present around the device
comply strictly with the safety regulations contained within this document.
This manual describes the operation and maintenance of the Armotion. ompliance with the
stated safety and operating instructions is a prerequisite for safe and proper operation of this
machine.
The user manual is integral part of the device and has to be kept near the related device, ensuring
access to operating personnel at all times. This user manual can also be accessed directly on the
P via a link in the program.
All images, pictures, diagrams, screenshots and drawings are figurative and can differ from the
effective appearance.
In addition to the hints provided by this manual, local accident prevention regulation, national
health and safety measures have to be taken into account.

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1.2 Ex lanation of Symbols
The symbols and signal words are used in order to point to hazards that can cause accidents,
injuries or property damage. The instructions must be observed in order to ensure the safe use
of the Armotion.
This combination of symbol and signal word points to an imminent danger that
may lead to death or serious injury if not avoided.
This combination of symbol
and signal word
indicates a
potentially hazardous
situation, which could result in death or serious injury if not avoided.
This combination of symbol
and
signal
word indicates
a potentially hazardous
situation which could result in moderate or minor injury, if it is not avoided.
NOTICE
This combination of symbol and signal word warns of a potentially dangerous
situation that could lead to material losses and environmental damage and /
or gives important additional information to be aware of.

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1.3 Warranty and Liability
The warranty and liability of Reha Technology AG are based on the purchase contract.
NOTICE
The warranty and liability shall ex ire rematurely if the customer or a third arty:
•uses and commands the Armotion not according to this manual,
•does not apply the national health and safety regulations,
•applies inappropriate changes or repairs to the device,
•allows changes, repairs or maintenance by physical or legal persons not certified by the
manufacturer of the device,
•impedes the installation and commissioning of the device by physical or legal persons
certified by the manufacturer of the device or the manufacturer itself,
•does not contact Reha Technology AG to provide assistance and repairs in case of
defect and/or does not take actions to minimize damage,
•uses non original or not by Reha Technology approved spare parts,
•does not comply with maintenance and cleaning instructions given by this manual.
NOTICE
The connection of devices not recommended in this manual is not permitted and must always
be agreed with Reha Technology AG.
Liability and warranty loss or voidance to o erate the the equi ment through unauthorized
modifications!
•All unauthorized technical modification is prohibited.

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Changes or modifications to this unit not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Defects which cannot be traced directly to Reha Technology by means of improper material
quality, faulty construction or assembly as well as defects caused by factors outside the control
of Reha Technology are excluded from warranty and liability regulations.
Liability of subsequent error is excluded if not in direct conflict with national product liability
regulations. This is valid also for defects which can provoke inherited damage to the device
known by the manufacturer.
Reha Technology reserves the right to implement technical modifications on the product in order
to improve the usage requirements and device characteristics.
1.4 Co yright Protection
The contents of this instruction manual including all figures and drawings are copyrighted
information and property of Reha Technology and are exclusively provided for the purpose of
operation, maintenance and repair.
Dissemination for other purposes or copying thereof without previous written consent by Reha
Technology is forbidden.

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2The Armotion™
2.1 General
The Armotion is an innovative robotic solution in the treatment of severe and moderate
neurological and orthopaedic dysfunction of the upper extremity.
The Armotion`s unique force feedback and force multiplier features detect and react on patient
movements, maximizing the effect of each therapy session. The combined recording of kinematic
(speed and direction) and dynamic (force interaction by the patient) parameters allow a precise
quantitative evaluation and constant monitoring of patient progress. The patient’s cognitive
ability is enhanced by multiple functional ADL-related game types and a unique active assistive
therapy option.
The substantial reduction in size, its portable and compact design and state of the art technology
makes the Armotion an easy to use device for the rehabilitation of the upper extremities. The
wireless connection to the computer, the rechargeable batteries and the short and simple setup
and quick start of therapy further contribute to an optimized allocation of the hospitals resources
on a daily routine.
The Armotion can easily be employed both in the treatment of severe and moderate neurological
dysfunctions (i.e. post stroke recovery) as well as in the rehabilitation of orthopaedic conditions.

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Patients exhibiting deficits in the range of motion and strength of the shoulder and elbow with
or without minor cognitive deficits related to recognition, find the use of Armotion an innovative
solution for a prompt functional recovery.
2.2 Manufacturing and O timization
The Armotion was designed and developed by Humanware S.r.l. and Reha Technology AG in
cooperation with the medical University of Pisa, Italy.
Reha Technology AG is interested in continual optimization of the practical use of the therapy on
patients and improvements to ease of operation of its devices. For this process Reha Technology
AG is dependent on you, as a regular user, for ideas and suggestions.
Please, do not hesitate to share your inputs by contacting: [email protected]
2.3 Ty e Label
At the bottom of the Armotion there is a label containing the following information

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3Safety Instructions
This chapter provides an overview of all important safety aspects for the safe and proper
operation of the Armotion.
3.1 Intended Use
Only when used according to the specifications of the user manual, the operating safety can be
guaranteed. The Armotion is intended only for use on patients with severe and moderate motor
disorder of the upper extremities – shoulder and elbow. Dedicated software, with numerous
exercises, allows the therapist to choose the ideal protocol according to the patient’s dysfunction
and therapeutic goal.
The software records and evaluates each exercise done by the patient
The fields of application include:
•Neurological Rehabilitation
•Post-traumatic rehabilitation
•Orthopaedic and after surgery rehabilitation
The Armotion also finds applications in those patients without force and / or without anti-gravity
abilities (i.e. patients who are unable to lift the arm/shoulder). The use of the Armotion in the
rehabilitation of the upper extremities has shown clinical effectiveness in the treatment of
patients with damage to the central nervous system (i.e. post stroke recovery) and in patients
with neurodegenerative syndromes and polyneuropathies. . . As mentioned it may be particularly
useful for those patients with serious motor limitations that therefore could not be treated with
conventional occupational therapy.
The Armotion is a medical device according to E class 2a and therefore it shall be used with a
prescribed physical therapy.

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Given the mentioned application areas of use, the practitioner defines the intended use and
mode of administration of therapy depending on the severity of the disease and diagnosis.
The system may not be o erated by non-qualified ersonnel!
Accidents and injuries due to ignorance and misuse
•Read the user manual
NOTI E
Any additional and / or different use of the Armotion is prohibited and is considered to be
improper.
3.2 Contraindications
As it is the case with any other therapy, the treating physician is responsible for compliance with
the indications.
3.2.1 General contraindications
•Unstable fractures of the upper extremity: do not carry out any therapy on patients with
unstable fractures or fractures which have not yet suitably consolidated.
•Heavy Osteoporosis: there might be a danger of fractures.
•Skin problems: Before and after each therapy make a visual check for existing wounds or
pressure points and for ones which may have been caused by the therapy.
•ooperation: whether or not a therapy on the Armotion can be carried out on patients
with reduced cooperation, psychotic illnesses or neurotic dysfunctions has to be carefully
considered in each individual case.
•Spasticity: Modified Ashworth Scale >3*

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Please note that other contraindications which are not listed here may be present in your
patients. If anything is unclear, or if you have feedback please contact Reha Technology AG. (See
contact details on the last page).
3.2.2 S asticity management
linical studies confirms that active movement training does not result in increased hypertonia,
but results in spasticity reduction in antagonist muscles by activating the reciprocal inhibition
mechanism. Furthermore robot –mediated therapy contributes to a decrease in motor
impairment of the upper limbs in subjects with chronic hemiparesis, resulting in a reduction on
shoulder pain.**
linical observation show how Armotion can accommodate neuromuscular abnormalities
associated with spastic joint evaluated on a Modified Ashworth Scale Bohannon & Smith value:
< or = 3.
As a general indication we recommend either both manual gentle muscle stretching techniques
(i.e conventional muscle stretching, muscle reinforcement, physical agent and pain management
techniques) prior to the training on Armotion.
When spams or alteration of the tone are observed during the therapy on Armotion, it is
recommended to stop the therapy by pressing one of the emergency stop.
Score
Ashworth Scale (1964)
Modified Ashworth Scale Bohannon & Smith (1987)
0
(0)
No increase in tone
No increase in muscle tone
1 (1)
Slight increase in tone giving a catch
when the limb was moved in flexion
or extension
Slight increase in muscle tone,
manifested by a catch and release
or by minimal resistance at the end of the range of motion when
the affected part(s) is moved in flexion or extension
1+ (2)
Slight increase in muscle tone, manifested by a catch, followed
by minimal resistance throughou
t the reminder (less than half)
of the ROM (range of movement)
2 (3)*
More marked increase in tone but
limb easily flexed
More marked increase in muscle tone through most of the ROM,
but affected part(s) easily moved
3 (4)
onsiderable increase in tone -
passive movement difficult
onsiderable increase in muscle tone passive, movement
difficult
4
(5)
Limb rigid in flexion or extension
Affected part(s) rigid in flexion or extension

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**Upper limb spasticity reduction following active training: a robot-mediated study in patients with chronic hemiparesis”
Posteraro et al, Journal Rehabilitation edicine 2010; 42: 279-281
3.3 General Hazards
Despite extensive risk analysis according to EN ISO 14971 remains a residual risk. A detailed risk
analysis of Reha Technology AG can be viewed up on request.
Injury risk by means of clam ing and crushing!
Abidance in areas of mechanically moved parts implicates the injury risk of clamping or
crushing.
•Abidance in areas of mechanically moved parts is not allowed during device motion
operation.
3.4 Personnel Qualification
To guarantee the safety of the patient of the operator and the device itself, and in order to
guarantee safe and successful therapy on the patient, the use of Armotion is allowed only after
having carefully read this instruction manual.
Future operators should fulfil the prerequisite of having absolved a medical training (e.g.
Medicine, Physiotherapy and Occupational Therapy).
The user manual gives the operators an overview over the following topics:
•Device handling and use according to regulations including practical exercises
•Device and function principles
•ommand settings
•Indications and recommended settings
•ontraindications and side effects
•Explanation of the maintenance operations carried out by operators (daily/monthly
control)

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4Specifications
The following section provides a general overview of the Armotion.
4.1 S ecifications in Detail
Designation of Type: Armotion
Year of manufacture: 2014
Applicable Norms: EN ISO 13485:2012, ISO 9001:2008,
IE 60601-1:2007, IE 60601-1-2:2010,
IE 60601-1-6:2010, IE 62304:2006
ISO 14971:2012, EN 14155:2012, EN 10993-1:2010
lassification: E class 2a
Type of application: rehabilitation of upper extremities
ountry of Origin: Switzerland
Power Supply: 11.1 V D , 10A
Highest permissible force: 40 N
4.2 O erating Conditions
Temperature: 15°, + 40 °
Humidity: 0% - 75 % relative humidity
NOTI E
The stationing of the device is limited to clean, dry rooms.
NOTI E
The
Armotion
may only be
under the supervision of
a medical specialist
.

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Ex losion ha
zard
when used
in
areas of danger of ex losion
!
The Armotion can provoke explosion by means of electric power supply components.
•The Armotion may not be used in areas of danger of explosion, zones AP and APG
according to IE 60601-1:1990.
•The use of flammable and explosive anaesthetic inhalation agents or combinations
thereof is not permitted in the surroundings of the Armotion
4.3 FCC com liance
This equipment has been tested and found to comply with the limits for a lass B digital device,
pursuant to part 15 of the F Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is
no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
— onnect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
— onsult the dealer or an experienced radio/TV technician for help.
This device complies with part 15 of the F Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.

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5omponents
5.1 Overview
The ARMOTION system consists of the following parts:
•One Armotion
•One height adjustable table
•One rubber working surface with encoded optical tracks
•An emergency stop “fungus” (connected to the Armotion)
•Three different handles
•One P and monitor (or all-in-one P depending on the country of use)
•Two rechargeable battery packs
•One docking station for recharging the battery
•Optionally: one USB Bluetooth adapter and its extension if not integrated in the P
onfiguration of the Armotion System as a whole

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The working surface provides an optical encoding allowing the Armotion to find its position at
any time. The working surface is also equipped with safety edges to prevent accidental falls of
the Armotion.
The patient's arm is resting on the support (Picture 3) and stabilized with the Velcro straps
provided. The patient interacts with the system by grasping the one of the provided handle.). A
force sensor detects the intensity and the direction of the force exerted by the user.
Arm support
Emergency stop
onnector for
external safety
switch
Main Switch
On-off
Exchangeble handle
Emergency stop
Exchangeable
battery
ounterweight

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Safety recautions
•Do not lift the Armotion by gripping it from the front part
For safety reason, the robot is equipped with an acoustic indicator that emits a variety of sounds
when in use
The picture above shows the Armotion as a whole. The Armotion interacts with a P using
dedicated software. ommunication with the P is done via Bluetooth.

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The patient will be required to perform therapeutic exercises according to his needs. While
performing the given exercise kinematic data (position, velocity and accelerations) and dynamic
data (the forces exerted by the patient) will be recorded.
Analysing these data, it will be possible to:
•orrect in real time the movements of the patient
•Evaluate the performance at the end of each therapy session
•Evaluate the progresses out of the overall therapies sessions
•Retrieve logged data for off-line analysis
The Armotion system can be used with three different handles, depending on the needs and
capabilities of the patient.
•2 horizontal handles, i.e. parallel to the work surface
•1 vertical handle, i.e. perpendicular to the work surface
Armotion
Dedicated
P

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•