background image

EN – 20 

Immunity Test 

IEC 60601-Test 

Level  

Compliance Level 

ELECTROMAGNETIC 

ENVIRONMENT - Guidance 

  

  

  

Recommended Separation 
Distance: 

Conducted RF 
IEC 61000-4-6 

6 V

rms 

 

150 kHz to 80 MHz  

6 V  

𝑑 = 0.58 √𝑃

 

Radiated RF 
IEC 61000-4-3  
  
  

10 V/m  

80 MHz to 2.7 GHz  

  
  
  

10 V/m  
  
  
  

𝑑 = 0.35 √𝑃

   80 MHz to 800 

MHz 
 

𝑑 = 0.7 √𝑃

  800 MHz to 2.5 

GHz  
 
where P is the maximum 

output power rating of the 

transmitter in watts (W) 

according to the transmitter 

manufacturer and d is the 

recommended separation 

distance in meters (m). 

Field strengths from fixed RF 

transmitters, as determined by 

an electromagnetic site 

survey

a

, should be less than the 

compliance level in each 

frequency range.

b

 

Interference may occur in the 

vicinity of equipment marked 

with the following symbol:   

  

NOTES: 
 - At 80 MHz and 800 MHz, the higher frequency range applies. 
 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption 
and reflection from structures, objects, and people. 

a

 

 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones 

and  land mobile  radios,  amateur  radio,  AM  and  FM radio  broadcast  and  TV broadcast  cannot  be 

predicted  theoretically  with  accuracy.  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, 

Summary of Contents for PABLO

Page 1: ...PABLO GEBRAUCHSANWEISUNG MANUAL Sprachen Languages Deutsch DE English EN Ausgabedatum der Gebrauchsanweisung 31 Mai 2017 Issue Date of User Manual 31st May 2017 ...

Page 2: ... 908 909 FAX 43 316 231123 9144 EMAIL office tyromotion com WEB www tyromotion com SUPPORT support tyromotion com Distributor TYROMOTION GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA PHONE 43 316 908 909 FAX 43 316 231123 9144 EMAIL office tyromotion com WEB www tyromotion com SUPPORT support tyromotion com ...

Page 3: ...LO system 12 1 3 1 Type label 14 Technology 16 2 1 Technology 16 2 1 1 Overview 16 2 1 2 Area of application 17 2 1 3 Repair 22 2 1 4 Disposal 22 2 2 Monthly functionality check Recurring check 22 2 2 1 Check list functionality test 22 2 2 2 Recurring checks 23 2 3 The PABLO System 24 2 3 1 PABLO Handsensor 24 2 3 2 PABLO Motionsensor 25 2 3 3 PABLO Multiboard 26 2 3 4 PABLO Multiball 26 2 3 5 PAB...

Page 4: ...tionsensor 38 Clinical application 40 4 1 Indications Contraindications 40 4 2 Safety 42 4 2 1 Safety concept 42 4 2 2 Residual risk 42 4 2 3 Patient information 42 4 3 Prior to training 42 4 3 1 Activating the PABLO system 42 4 4 Performing training 43 4 4 1 Attaching the PABLO system to the patient 43 4 4 2 Application 46 4 5 After training 46 4 5 1 Detaching the patient from the PABLO system 46...

Page 5: ...perative that every user completes the training course and has read the user manual prior to using PABLO 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 PABLO system are not obser...

Page 6: ...PABLO Multiboard installation 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 Tha...

Page 7: ...ead the provided user manual for the tyroS software and the accompanying documents Medical personnel and properly trained therapists responsible for the PABLO system are required to warn 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...

Page 8: ...our manufacturer s warranty The straps are consumables in other words wear parts Warnings from chapter 2 Electromagnetic compatibility PABLO 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 equip...

Page 9: ...wireless communication via Bluetooth use a similar bandwidth to Wi Fi the signal may be lost occasionally Warnings from chapter 4 Is the system suitable for the intended therapy Continual checking of the therapy success of the patient Stop of the treatment if there is a sign of disproportional worsening of the patient s condition Safety concept Clinical application The responsible therapist must a...

Page 10: ...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 PABLO 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 e...

Page 11: ...ies 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 sup...

Page 12: ...Please note that the PABLO Strap Set is not covered by our manufacturer s warranty The straps are consumables in other words wear parts 1 2 Training concept The PABLO system is a complex technical device Users of the PABLO 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 manua...

Page 13: ...formation 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 Motionsensor Table 1 Symbols on PABLO system ...

Page 14: ... 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 ...

Page 15: ...EN 15 PABLO Multiball Figure 4 Type label PABLO Multiball PABLO Multiboard Figure 5 Type label PABLO Multiboard ...

Page 16: ...ected to the PUBLIC SUPPLY GRID which also supplies residential buildings Country of origin AUSTRIA Power supply voltage 110 240V alternating current Supply frequency 50 60Hz Electricity Power consumption 5V DC 5A 25W Battery Contained power solution Polymer lithium ion battery 3 7V 480mAh The battery must not be replaced Radio transmission frequency 2 4 GHz Band Bluetooth 2 1 Radiated transmissio...

Page 17: ...tel or AMD Processor with 1 6GHz at least 4 GB RAM Display resolution 1280x768 Microsoft NET framework 4 5 2 installed by default Unity3D Webplayer Plugin installed by default One free USB port 2 1 2 Area of application Device usage is principally limited to clean dry rooms within professional health care establishments Operation Temperature 10 30 C Humidity 30 75 relative humidity Storage and tra...

Page 18: ... very low and unlikely to disrupt electronic devices within range HF emissions according to CISPR 11 Class B The PABLO system is suitable for usage in all establishments including residential areas and areas that are directly connected to the PUBLIC SUPPLY GRID which also supplies residential buildings Harmonics emissions according to IEC 61000 3 2 Class A Emissions of voltage fluctuations flicker...

Page 19: ...or 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the AC mains voltage before application of the test level Tabl...

Page 20: ...in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTES At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio...

Page 21: ...cording to maximum output power of the communications equipment Rated Maximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter 150 kHz to 80 MHz 𝑑 0 58 𝑃 80 MHz to 800 MHz 𝑑 0 35 𝑃 800 MHz to 2 5 GHz 𝑑 0 7 𝑃 0 01 0 058 0 035 0 07 0 1 0 18 0 11 0 22 1 0 58 0 35 0 70 10 1 83 1 11 2 21 100 5 80 3 50 7 00 For transmitters rated at a maximum output power not liste...

Page 22: ...on Malfunction Resulting measure Protective covers Covers shake Covers missing Covers damaged Further use is prohibited Contact TYROMOTION GmbH Externally visible deformations Parts bent out of shape Parts asymmetrical Parts defective Further use is prohibited Contact TYROMOTION GmbH Cleaning PABLO system contaminated Further use is prohibited Clean the contaminated parts as described in chapter 4...

Page 23: ...acement The device operator is responsible for performing both checks TYROMOTION GmbH has determined an interval of one year for 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 no...

Page 24: ...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 Additionally the range of motion of the arm shoulder elbow and wrist can be determined by means of position sensors Furthermore the PABLO Handsensor offers the possibility of a haptic feedback rendition by means of vibration Please ...

Page 25: ...ched to various parts of the upper and lower extremities as well as the torso with the straps included in the set Furthermore the PABLO Motionsensor offers the possibility of a haptic feedback rendition by means of vibration The sensors included in the set offer a variety of therapeutic possibilities when used in combination with the tyroS software Please also observe the user manual for the tyroS...

Page 26: ...BLO 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 2 3 4 PABLO Multiball Figure 9 PABLO Multiball ...

Page 27: ...ively up to two PABLO Handsensor with the PABLO Charger Place the PABLO Sensors in the designated positions 2 3 6 Explanation of the LED Display at the PABLO system LED Display Meaning Necessary Action Shining RED Connection with software okay battery level under 15 Charging the battery section 2 3 7 Flashing RED No connection with software battery level under 15 Charging the battery section 2 3 7...

Page 28: ...ng process Follow the instructions however about the use of the device during a charging process The use of charging units that have not been recommended by TYROMOTION GmbH is expressly forbidden because unforeseen risks could arise for people and equipment 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 s...

Page 29: ...ll 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 As a general rule however the charging process should not last longer than 4 hours In this connection see the LED display at the PABLO Sensors If the LED flashes blue then the charging process is active If the LED shines b...

Page 30: ...er to prevent the battery inside the device from becoming too hot Battery life In use the battery service life is approximately 8 hours when fully charged thereafter the battery will have to be charged again 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 app...

Page 31: ...e purchased a PC from TYROMOTION this installation will already have been carried out Otherwise connect the Bluetooth adapter to the USB extension and then to a free USB port of your PC and follow the installation instructions of your PC Figure 13 Bluetooth adapter Figure 14 Bluetooth adapter incl USB extension Use only the supplied adapter to set up the Bluetooth connection 3 3 Connecting PABLO s...

Page 32: ... completed and the PABLO system is now ready for use Repeat these steps for all PABLO Sensors 3 3 3 Windows 7 Go to Control Panel and select Devices and Printers Click on Add Device 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 r...

Page 33: ...Start the tyroS software by double clicking on the tyroS symbol on your desktop 5 The PABLO system connects itself to your PC automatically via Bluetooth technology as soon as you start a therapy session with the PABLO system Please note the LED display on the PABLO Handsensor and the PABLO Motionsensor Chapter 2 3 6 This gives information on the current status of the PABLO system As the PABLO Sen...

Page 34: ...ndsensor 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 strap is pulled through the lower strap Figure 16 Fixation of the finger strap 1 Figure 17 Fixation of the finger strap 2 ...

Page 35: ...ABLO 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 1 Remove the PABLO Multiball and the supplied straps from the packaging and place them in front of you Make sure the short Velcro straps with stoppers are at the back and the long Velcro straps are at the front Figure 20 PABLO Multibal...

Page 36: ...lipping off the strap clamps when unfastened Figure 21 Threading the short straps at the back 3 Now thread the long Velcro straps through the wide strap clamps at the front of the PABLO Multiball Make sure the Velcro fastener faces upwards Figure 22 Threading the long straps at the front 4 Now thread the wide strap through the wide strap clamp at the front of the PABLO Multiball Make sure the Velc...

Page 37: ...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 Figure 24 Mount the hand rests to the main arm Figure 25 Mount the handle to the main arm ...

Page 38: ...e 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 PABLO Multiball Figure 26 Correct alignment of the PABLO Motionsensor on the PABLO Multiball PABLO Multiboard Figure 27 Correct alignment of the PABLO Motionsensor on the PABLO Multiboard ...

Page 39: ...EN 39 Correct alignment of the PABLO Motionsensor in conjunction with straps Figure 28 Correct alignment of the PABLO Motionsensor in conjunction with straps ...

Page 40: ...ions exist Also be aware that your patient may have additional indications and or contraindications that have not been listed here but may be relevant The following listings have no claim to completeness Common Indications Stroke cerebral hemorrhages ischemic damages Traumatic brain injury TBI Spinal cord injury SCI Brain tumor Parkinson s disease Chronic diseases e g multiple sclerosis MS Cerebra...

Page 41: ... essential The PABLO system does not influence heart pacemakers if the distance between pacemaker and device is more than 15 cm Infections Joint problems Repetitive training may cause pain and irritation in case of weak joints Neglect Osteoporosis Orthostatic circulatory problems Pain e g complex regional pain syndrome CRPS Sensory disorders Patients with sensory impairment cannot report potential...

Page 42: ...autions In rare cases the patient may experience minor pinching or crushing injuries even during proper operation 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 4 2 3 Patient information Patient relevant information...

Page 43: ...e patient and thus ensure the best therapy results possible Please note Check for possible existing circulatory disorders before attaching the straps to the patient In case of indication of any such disorder the patient must be regularly examined and checked for pain swellings and skin discoloration during therapy with the PABLO system If the patient shows any signs of such indications the therapy...

Page 44: ...ist strap to the PABLO Handsensor Attaching the PABLO Multiball Proceed as follows when attaching the hand to the PABLO Multiball 1 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 2 If needed you can also fixate the thumb using the long Velcro strap ...

Page 45: ...e 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 1 Attach the strap to the desired part Choose a suitable strap length Figure 33 Strap for the PABLO Motionsensor Figure 34 Fixing possibilities PABLO Motionsensor ...

Page 46: ...actions if attaching the straps directly to the skin 4 4 2 Application Apply the PABLO system and follow the instructions given by the software Please always observe the tyroS software user manual throughout the entire training 4 5 After training 4 5 1 Detaching the patient from the PABLO system After use detach the patient from all used PABLO components 4 5 2 Storing the PABLO Sensors After use p...

Page 47: ...objects that come into contact with the patient and the therapist should be cleaned and disinfected in order to minimize the risk of spreading germs Use a disposable cloth with alcohol containing surface disinfectant for disinfection and cleaning since this method does not require a long application time Ensure that the disposable cloth is only lightly dampened with disinfectant Never use abrasive...

Page 48: ...long can I use a charged PABLO Sensor for therapy In use the battery service life is approximately 8 hours when fully charged thereafter the battery will have to be charged again Which motions can be monitored with the PABLO system 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 bod...

Page 49: ...s 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 Also see chapter 4 4 1 ...

Page 50: ...TYROMOTION GMBH Bahnhofgürtel 59 8020 Graz Austria PHONE 43 316 908 909 FAX 43 316 231123 9144 EMAIL office tyromotion com WEB www tyromotion com SUPPORT support tyromotion com ...

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