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Tyromotion PABLO Manual

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PABLO®
GEBRAUCHSANWEISUNG / MANUAL
Sprachen / Languages: Deutsch (DE), English (EN)
st
Ausgabedatum der Gebrauchsanweisung: 31. Mai. 2017 / Issue Date of User Manual 31
May 2017

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Summary of Contents for Tyromotion PABLO

  • Page 1 PABLO® GEBRAUCHSANWEISUNG / MANUAL Sprachen / Languages: Deutsch (DE), English (EN) Ausgabedatum der Gebrauchsanweisung: 31. Mai. 2017 / Issue Date of User Manual 31 May 2017...
  • Page 2 Contact information: Manufacturer: TYROMOTION GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA PHONE +43 316 908 909 +43 316 231123 9144 EMAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com Distributor: TYROMOTION GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA PHONE +43 316 908 909 +43 316 231123 9144 EMAIL office@tyromotion.com...

  • Page 3: Table Of Contents

    PABLO® Motionsensor 2.3.3 PABLO® Multiboard 2.3.4 PABLO® Multiball 2.3.5 PABLO® Charger 2.3.6 Explanation of the LED Display at the PABLO® system 2.3.7 Battery 2.3.8 Switching the PABLO® Sensors on/off Preparation/Basic Information Installation of the Software Installation of the Bluetooth adapter...
  • Page 4 Residual risk 4.2.3 Patient information Prior to training 4.3.1 Activating the PABLO® system Performing training 4.4.1 Attaching the PABLO® system to the patient 4.4.2 Application After training 4.5.1 Detaching the patient from the PABLO® system 4.5.2 Storing the PABLO® Sensors 4.5.3...

  • Page 5: Introduction

    Introduction 1.1 Introduction We are happy to provide this user manual as an introduction for the usage of the PABLO® system. The following user manual addresses the essential functions that are necessary for understanding the functionality and usage of the PABLO® system.

  • Page 6: System Content

     USB stick (User manual, tyroS® Software) Only use original accessories from the manufacturer. Accessories or spare parts such as PABLO® Strap Set can be obtained directly from the manufacturer. 1.1.4 The therapy system The PABLO® Handsensor offers measuring options for various grasping patterns of the human hand, including resulting force, and allows the depiction of trends.

  • Page 7: Intended Purpose

    1.1.7 Safety The PABLO® system can only be used 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...

  • Page 8: Warning

    Accessory: Only use original accessories from the manufacturer. Warranty and legal disclaimer: Please note that the PABLO® Strap Set is not covered by our manufacturer’s warranty. The straps are consumables, in other words wear parts. Warnings from chapter 2 Electromagnetic compatibility: PABLO®...
  • Page 9 TYROMOTION GmbH is expressly forbidden, because unforeseen risks could arise for people and equipment. Make sure there are no other objects than the charging PABLO® Sensors on the PABLO® Charger, as they may cause harm to the device as well as to people.

  • Page 10: Owner's Responsibility

    Storing the PABLO® Sensors: Make sure all PABLO® components are securely stowed after use so they cannot fall on the floor and thus cause harm to patients and or break. Cleaning PABLO® system and associated parts The hygienic instructions stated in chapter 4.5.3 must be strictly observed.

  • Page 11: Warranty And Legal Disclaimer

    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.

  • Page 12: Training Concept

    Users are able to perform initial and repeated therapies training with the PABLO® system. Users are not permitted to instruct other persons in the usage of the PABLO® system. Users are trained by a member of TYROMOTION GmbH or by another trainer delegated by TYROMOTION GmbH.
  • Page 13 Do not discard with household waste. CE mark IP22 Protection class for foreign objects and water Information about the manufacturer of PABLO®, including the manufacturer's full mailing address is displayed next to the factory symbol. On-switch for PABLO® Handsensor and PABLO® Motionsensor Contact area for wireless battery charging Direction indicator for correctly attaching the PABLO®...

  • Page 14: Type Label

    1.3.1 Type label The type labels designate the PABLO® system as a medical product. PABLO® Handsensor Figure 1: Type label PABLO® Handsensor PABLO® Motionsensor Figure 2: Type label PABLO® Motionsensor PABLO® Charger Figure 3: Type label PABLO® Charger EN – 14...
  • Page 15 PABLO® Multiball Figure 4: Type label PABLO® Multiball PABLO® Multiboard Figure 5: Type label PABLO® Multiboard EN – 15...

  • Page 16: Technology

    Can also be determined from the serial number, e.g. SN: PR4-2017-XXX refers to the year 2017. Classification: The PABLO® system is an active, therapeutic class I medical product according to regulation 1 and 13 of the Council's Directive 2017/745 MDR. Type of applied part:...

  • Page 17: Area Of Application

    Temperature: -20 ... 60 °C Humidity: 20 ... 90 % relative humidity, no dew Caution: The PABLO® 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 PABLO®...
  • Page 18 Guidelines and MANUFACTURER‘s declaration – ELECTROMAGNETIC EMISSIONS The PABLO® system is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below. The customer or user of the PABLO® system must ensure that it is used in such an environment. Interference emission Agreement ELECTROMAGNETIC ENVIRONMENT –...
  • Page 19 The PABLO® system is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below. The customer or user of the PABLO® system must ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 20 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PABLO® system is used exceeds the applicable RF compliance level above, EN – 20...
  • Page 21 Recommended separation distances between portable and mobile RF communications equipment and PABLO® system The PABLO® system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device can help prevent electromagnetic interference by...

  • Page 22: Repair

    2.1.3 Repair Always contact the manufacturer for repairs! 2.1.4 Disposal The PABLO® system must not be disposed of in the same manner as normal waste, but returned to the company TYROMOTION GmbH. Monthly functionality check / Recurring check 2.2.1 Check list functionality test The functionality checks described here must be performed on a monthly basis.

  • Page 23: Recurring Checks

    Recurring checks may only be carried out by technically qualified personnel. The device operator must ensure that the intervals for the recurring checks stipulated by him are observed. Usage of the PABLO® system must cease if the inspection intervals are not observed.

  • Page 24: The Pablo® System

    The hand’s extension- and flexion forces can be measured by means of force sensors inside the cylindrical handles. The special design of the PABLO® Handsensor allows for measuring the force of functional grasp motions such as pincer-, lateral- and interdigital grips.

  • Page 25: Pablo® Motionsensor

    2.3.2 PABLO® Motionsensor Figure 7: PABLO® Motionsensor The PABLO® Motionsensor is connected to the PC via Bluetooth and can be used both independently and in combination with the PABLO® Multiball, PABLO® Multiboard or the included strap set. It is a portable, compact and wireless sensor for monitoring spatial movement.

  • Page 26: Pablo® Multiboard

    2.3.3 PABLO® Multiboard Figure 8: PABLO® Multiboard The PABLO® Multiboard, in combination with the PABLO® Motionsensor, is used for active training of the entire upper extremity and the torso. With this component, the elbow- and shoulder-joints can be moved in different directions.

  • Page 27: Pablo® Charger

    -extension. 2.3.5 PABLO® Charger Figure 10: PABLO® Charger You can charge up to six PABLO® Motionsensors respectively up to two PABLO® Handsensor with the PABLO® Charger. Place the PABLO® Sensors in the designated positions.

  • Page 28: Battery

    Charging Battery: In order to charge the batteries, first connect the PABLO® Charger to a plug and then put the PABLO® Sensors onto the charging sockets destined for the sensors. The PABLO® Sensors switches into the charging mode automatically (Note the LED display described in Chapter 2.3.6).
  • Page 29 TYROMOTION GmbH is expressly forbidden, because unforeseen risks could arise for people and equipment. Make sure there are no other objects than the charging PABLO® Sensors on the PABLO® Charger, as they may cause harm to the device as well as to people. Duration of Charging: The duration of charging depends, among other things, upon whether the battery was fully uncharged at the start of the charging process or not.

  • Page 30: Switching The Pablo® Sensors On/Off

    2.3.8 Switching the PABLO® Sensors on/off A short push of the switch turns on the PABLO® Sensors. The system vibrates briefly. The PABLO® Handsensor and the PABLO® Motionsensor are ready for use approx. 3 seconds after being switched on.

  • Page 31: Preparation/Basic Information

    Software. 3.2 Installation of the Bluetooth adapter The PABLO® system is connected to your PC with Bluetooth technology. In order to produce this connection, it is first necessary to connect the Bluetooth adapter included in the scope of delivery to your PC and to install it. If you have purchased a PC from TYROMOTION this installation will already have been carried out.

  • Page 32: Windows 10

    After a while, all nearby Bluetooth devices appear. Select the entry “Serial Adapter” or the device with the PABLO® serial number and click on “Next”. Then click on “Close”. Installation is completed and the PABLO® system is now ready for use.

  • Page 33: Preparation Of The Pablo® System

    Wi-Fi, the signal may be lost occasionally. 3.5 Preparation of the PABLO® Handsensor In order to prevent any therapy disruption as well as damage to the PABLO® Handsensor, the sensor can be attached to the patient’s hand with the hand strap included.
  • Page 34 Pull the finger strap through the two strap clamps on the left-hand side of the PABLO® Handsensor, starting from the bottom. Then, pull the wrist strap through the strap clamps on the right-hand side of the PABLO® Handsensor. Make sure the orange Velcro® strap is pulled through the upper-, and the black Velcro®...

  • Page 35: Preparation Pablo® Multiball/Multiboard

    3.6 Preparation PABLO® Multiball/Multiboard 3.6.1 PABLO® Multiball In order to prevent any therapy disruption as well as damages to the PABLO® Multiball, it can be attached to the patient’s hand with the strap included. Remove the PABLO® Multiball and the supplied straps from the packaging and place them in front of you.
  • Page 36 Now, thread the short Velcro® straps with the stoppers through the narrow strap clamps at the back of the PABLO® Multiball. Make sure the Velcro® fastener faces upwards. The stoppers prevent the short Velcro® straps from slipping off the strap clamps when unfastened.

  • Page 37: Pablo® Multiboard

    Figure 23: Threading the wide strap at the front 3.6.2 PABLO® Multiboard The PABLO® Multiboard is disassembled when delivered (main arm, two hand rests, one handle). Mount the single components of the PABLO® Multiboard with the 6 raised flathead screws included. Use the hex driver included.

  • Page 38: Preparation Pablo® Motionsensor

    3.7 Preparation PABLO® Motionsensor The PABLO® Motionsensor can be mounted to and dismounted from the PABLO® Multiball or the PABLO® Multiboard with the buckle release, or connected with the strap system. When mounting the PABLO® Motionsensor, make sure that the arrow on the housing always points in the correct direction.
  • Page 39 Correct alignment of the PABLO® Motionsensor in conjunction with straps Figure 28: Correct alignment of the PABLO® Motionsensor in conjunction with straps EN – 39...

  • Page 40: Clinical Application

    Before applying PABLO® therapy to a patient, check carefully if one or more contraindications exist. Also, be aware that your patient may have additional indications and/or contraindications that have not been listed here but may be relevant.
  • Page 41 Fractures: Do not carry out training with unstable or still inadequately consolidated fractures Relative Contraindications: Each patient has to be conscientiously assessed by the doctor/therapist in charge individually to determine if PABLO® therapy is suitable for the patient in case of:  Apraxia ...

  • Page 42: Safety

    However, the probability of such injuries is very low, and the injuries should not be severe as long as all safety instructions in the present user manual are observed. TYROMOTION GmbH can provide a detailed risk analysis upon request.

  • Page 43: Performing Training

    The PABLO® system connects itself automatically to your PC via Bluetooth technology as soon as you start a therapy session with PABLO®. Please note the LED display at the PABLO® Sensors (chapter 2.3.6). This gives information on which status the PABLO®...
  • Page 44 Attaching the PABLO® Multiball Proceed as follows when attaching the hand to the PABLO® Multiball. Place the hand on the PABLO® Multiball and fixate the hand with the straps as follows. Figure 31: For fixation of the hand, attach the strap to the PABLO® Multiball If needed, you can also fixate the thumb using the long Velcro®...
  • Page 45 Figure 32: Fixation of the thumb on the PABLO® Multiball Attaching the PABLO® Motionsensor The sensors can be attached to various parts of the upper and lower extremities as well as the torso with the straps included in the set.

  • Page 46: Application

    Click the PABLO® Motionsensor into the designated bracket. PLEASE NOTE: When attaching the PABLO® Motionsensor, make sure that the arrow on the housing always points upwards. Figure 35: Correctly attaching the PABLO® Motionsensor Using the straps to fixate the PABLO® Motionsensor may cause skin irritations.

  • Page 47: Cleaning Pablo® System And Associated Parts

    4.5.4 Switching off the PABLO® system Terminate the application by exiting the tyroS® Software and closing down the PC. If a PABLO® Sensor is disconnected from the software for more than an hour, it will switch off automatically. Please always observe the tyroS® software user manual throughout the entire training.

  • Page 48: Faq-Frequently Asked-Questions

    When using the PABLO® System, certain aspects have to be considered in order to achieve correct values. The PABLO® Sensor has to be fixated or attached to the patient’s body in such a way that it can tilt or rotate during therapy as depicted in Figure 36 and Figure 37.
  • Page 49 Figure 38: Linear motions without tilting of the sensor cannot be measured or lead to inaccurate values Why are the angles displayed in the tyroS® Assessments inverted when using the PABLO® Motionsensor? Make sure the sensor is attached and aligned correctly (note the direction of the arrow on the housing).
  • Page 50 TYROMOTION GMBH Bahnhofgürtel 59 8020 Graz, Austria PHONE +43 316 908 909 +43 316 231123 9144 EMAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com...

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