Quattro - OT Bioelettronica
Contents
1. following local regulations Follow the disposal regulations of your country in order to ensure the correct disposal of the Quattro and its accessories For further information about the disposal of this device contact the Environment Department and local authority Life span of the device A Warning Do not dispose this product as unsorted municipal waste Collection of such waste separately for special treatment of necessary following the 2002 96 EC of the European Parliament and European Council on waste electrical and electronic equipment WEEE The regulation is not valid in case of corrupted product The Quattro system is produced in order to last if the use and maintenance conditions indicated in this User s manual are followed The life span of the device is determined by the life span of the battery 5 years After this period it is recommended to take the device to the manufacturer every two years v1 2 Ed 07 2014 Pag 14 17 OT Bioelettronica snc 10 TECHNICAL SPECIFICATIONS User Manual ABIE XZ elettronica The Quattro device is a battery system designed following the medical regulations in order to ensure the patient safety The signal amplified by the system is transferred to a PC by wired USB cable or by wireless Bluetooth modalities In table 1 technical specifications of the Quattro device are reported Model Quattro Classification Battery system Degree of Protect2. OT Bioelettronica snc User Manual Y elettronica User s Manual Quattro A Read this manual carefully before using Quattro v1 2 Ed 07 2014 Pag 1 17 OT Bioelettronica snc User Manual Y 3 elettronica ZIO elettronica OT Bioelettronica C so Unione sovietica 312 10135 Torino www otbioelettronica it mail otbioelettronica it v1 2 Ed 07 2014 Pag 2 17 OT Bioelettronica snc User Manual NS 3 elettronica SYMBOLS USED The graphic symbols used on this device and on this manual refer to the UNI EN ISO 980 Law CEI EN 60601 1 RAEE Law and 2002 96 ECC Directive SYMBOL DESCRIPTION Serial Number Device with BF parts Class Il device Warning read the instructions before using the device This symbol could also be used as a Warning symbol Manufacturer Do not dispose this product as unsorted municipal waste Collection of such waste separately for special treatment is necessary following the 2002 96 EC Law of the European Parliament and Council of the European Union about the disposal of e waste SN li Read the instructions of use The Quattro device has been tested in reference to the EN 60601 1 and the EN 60601 1 2 Law If the user connects the Quattro device to any other unauthorized device following the EN 606011 and EN 60601 1 2 Laws he she has to ensure that the combined use of the two devices follows the laws above mentioned Otherwise OT Bioelettronica sha
3. T Bioelettronica snc User Manual Geile KIND OF PATIENT a Age gt 15 years b c Health No cardiovascular problems no pacemakers d Weight Not Important Nationality not relevant 5 SAFETY CAUTIONS AND WARNINGS The use of Quattro is forbidden in the following conditions e Simultaneous use of electro surgery systems shortwave or microwave therapy or near these type of devices e Unsound mind patient e The device is damaged e Near inflammable anaesthetics with air oxygen or nitrous oxide e Tomake an electrocardiographic exam e Pacemaker users These warnings must be followed e Contact immediately the manufacturer if foreign materials liquids etc come into contact with the device e lf the device falls in to the ground or something similar happens check if the device is undamaged In case of doubt contact the manufacturer The Quattro could be sensitive to electromagnetic interferences of other devices that could alter its electromyography measurements and consequently the physiological variables calculated on the basis of the information detected For this reason do not use it near devices that could cause the problems described above for example mobile phones instruments with power transformer etc e The operator must be sure that the battery of the device is completely charged following what is indicated in this User s Manual before to give the device to the patient e The device must be kept out of rea
4. ch of children or unsound mind patient e Do not clean the device using acetone ether freon oil products or any other solvent e Do not use soap or water on the connector pin e Do not clean Quattro or connection cables with water in autoclave or steam cleaning A The device must not be used in any other vvay than indicated in these instructions v1 2 Ed 07 2014 Pag 7 17 OT Bioelettronica snc User Manual NS 3 elettronica 6 CONTENT OF THE QUATTRO KIT ACCESSORIES AND DOCUMENTS Description Features USB connection cable to CUSB03 recharge internal battery UNSTERILE REUSABLE and for PC connection ADx5JC 4 bipolar electrodes UNSTERILE REUSABLE connection adapter TRBELTO1 Belt holder UNSTERILE REUSABLE A The accessories of the machine indicated above are to be considered as part of the device itself so they are not subject to C marking ACCESSORIES NEEDED BUT NOT INCLUDED IN THE STANDARD EQUIPMENT Description STERILE SINGLE USE Concentric Detection electrodes Bipolar detection electrodes Bipolar detection electrodes A Use of the equipment accessories and or C accessories of the OT Bioelettronica to be used for the detection of the electromyography signals v1 2 Ed 07 2014 Pag 8 17 OT Bioelettronica snc User Manual 7 DETAILED DESCRIPTION ABIE IZ elettronica Controls indicators and connectors of the Quattro are shown in Fig 1 and describe
5. ct with the investigated muscles e take the snap on connector of the reference cable and connect it to the reference electrode displaced on a point without EMG activity e wear the chest belt e connect the electrode adapter to the interested electrodes e switch on the Quattro device using the ON OFF switch e connect the USB cable CUSB03 for wired recordings e run the OT BioLab software and proceed with the signal acquisition see OT BioLab SW manual e at the end of the measurement session remove the electrodes and disconnect them Disconnect the electrode adapter from the Quattro device and then put the device and its accessories back in its packaging Throw away the single use electrodes A The single use concentric electrodes cannot be reused v1 2 Ed 07 2014 Pag 11 17 OT Bioelettronica snc User Manual Y 3 elettronica 8 TROUBLESHOOTING This section describes the most common problems that may be found by Quattro users Problem Description How to deal with it After the Quattro switch on the Check the Battery charge Bluetooth connection is not available Battery empty so recharge it or The red LED Error is switched on OO Data transmission error please move near to the PC tablet smartphone with Quattro device v1 2 Ed 07 2014 Pag 12 17 OT Bioelettronica snc User Manual S 3 elettronica 9 QUATTRO MAINTENANCE AND STORAGE Quattro has to be used transported and stored in the following c
6. d in the following sections Frontal View Posterior View Designed by OT Bioelettronica Adapter Inputs Torino Italy otbioelettronica it Analog Out Battery Error Status Recharge USB ON Fig 1 Front view and Back view of the Quattro v1 2 Ed 07 2014 Analog Out Battery Error LED Status LED Recharge LED USB connector ON OFF Connector Pag 9 17 OT Bioelettronica snc User Manual NS 3 elettronica Description of controls indicators and connectors shown in fig 1 Adapters Inputs These for inputs allow the connection of electrode adapters ADx5JC Analog Out At this connector are available the 4 EMG signals amplified and filtered in an analog modality after octocoupling Battery Error LED This red LED is normally off it switch on when the battery is empty and when there is some loose of data during Bluetooth transmission Status LED This LED flashes blue when Quattro is working Recharge LED This red LED switches on to indicate that battery are under charge It switch off when battery are fully recharged USB connector this connector is used to recharge battery and to transfer data from Quattro to the PC ON OFF switch With this switch is possible to turn off and on the Quattro system When the system is connected via USB to the PC it is automatically on independently of the ON OFF switch position Electrode adapters to detect the electromyography signals produced by musc
7. hic EMG device This system has been designed to detect surface electromyography signals SEMG from skeletal muscles with the use of the surface electrodes The information detected from electrodes is then transferred to a PC with a wired connection USB or with a wireless connection Bluetooth The Quattro works with a software named OT BioLab in order to display and process the data This software is part of the Quattro system and it is also possible to download it for free on the website www otbioelettronica it in the Downloads section 2 INTENDED USE Quattro has been designed to be used as an electromyography to detect the activity of skeletal muscles up to 4 muscles simultaneously N The device is not intended to be used near inflammable anaesthetics 3 PLACE OF USE Quattro is intended to be used primarily as a laboratory device and secondly as a hospital device as a home device the patient uses the device at home during the day and as a hospital device the operator uses the information detected from it in order to make a diagnosis 4 USER PROFILE USER Specialized operator a Knowledge Minimum Basic notions about the human body b c Experience Minimum Minimum training about the device use d Languages Italian and or English Handicaps Maximum reduction of the hearing of 40 with residual hearing at 60 Maximum sight reduction of 40 with residual sight at 60 v1 2 Ed 07 2014 Pag 6 17 O
8. ion IP32 Case Plastic case Power Supply 3 7V Battery rechargeable Battery time 8 Hours full charge Charging time 2 hours Class Numbers of Channels 4 Dynamics 0 3 3 mVpp Band 10 500Hz Input Noise lt 2 uVrms Amplification 150 V V Input impedance gt 102 Q on the entire bandwidth CMRR gt 96 dB Output Dynamics 0 3 3V A D converter resolution 16 bits Wireless transmission modality Bluetooth Wired transmission modality USB Sampling rate 1 024 Hz Dimensions 59 x 95 x 20 mm Weight 90g TAB 1 Technical Specifications of the Quattro v1 2 Ed 07 2014 Pag 15 17 OT Bioelettronica snc User Manual NS 3 elettronica A CUSTOMER SERVICE Quattro has no parts that can be replaced or repaired by the user contact the distributor for assistance so that he she can repair or replace the products under vvarranty Maintenance and replacement of parts modifications and or reparations made by unauthorized Companies and or operators by OT Bioelettronica will forfeit entitlement to warranty OT Bioelettronica denies any and all responsibility for damages caused directly or indirectly as a result of maintenance replacement of parts modifications and or reparations made by Companies and or operator that are not authorized by the OT Bioelettronica Quattro does not need any prior mainte
9. les the Quattro needs at least one of the four adapters ADx5JC connected Each one of ADx5JC adapters ends with a jack connector in one termination the other termination can be composed by different connectors according to the selected electrodes to place on the skin Aro make a proper measurement the adapter ADx5JC with snap on reference must be connected to Quattro device USB cable charge battery cable The Quattro device has as accessory a USB cable called CUSB03 USB miniUSB This cable allows charging Quattro by its connection to a USB PC port or to a power supplier that incorporates an USB output v1 2 Ed 07 2014 Pag 10 17 OT Bioelettronica snc User Manual NS 3 elettronica System Requirements for PC connection 1 Windows Operating system for PC Windows XP Vista Windows 7 Windows 8 2 USB port to recharge the Quattro equipment Behaviour of the device during battery charge process During the battery charge process the red Recharge LED located on the Quattro right side posterior view becomes red till the end of the recharge process when the battery is fully charged the red LED switches off AN Charge the device for at least 2 hours before to use it Application and acquisition with the Quattro device To use the Quattro system properly please follow these instructions e connect electrode adapter adapters ADx5JC to the Quattro device e take the electrodes and apply them that means in direct conta
10. ll not be held liable for accidents and or injuries to persons or damage For the features of the software please read the Software Manual v1 2 Ed 07 2014 Pag 3 17 OT Bioelettronica snc User Manual Y 3 elettronica v1 2 Ed 07 2014 Pag 4 17 OT Bioelettronica snc User Manual NS 3 elettronica INDEX 1T GENERAL DESCRIP HON aaa pag 2 INTENDED USE uns pag Es PLACE OF USE scia pag 4 OPERATOR AND PATIENT PROFILE lu pag 5 SAFETY PRECAUTIONS AND WARNINGS ii pag 6 CONTENT OF THE QUATTRO SYSTEM nn pag T DETAILED DESCRIPTION suini iii pag Electrode adapters ii pag USB cable for battery charge era ataca cinta pag System requirements for PC connection e pag Behaviour of the device during battery charge process pag Application and processing with Quattro device pag 8 TROUBLE SHOOTING ira pag 9 MAINTENANCE AND STORAGE pag epa clip che e WIGS RR pag Disposal t Riario pag Life span of the device arenas pag 10 TECHNICAL SPECIFICATIONS nn pag CUSTOMER SERVICE qu ascended pag Ci ia pag v1 2 Ed 07 2014 oN DD Oo OD 10 11 11 11 12 13 13 14 14 15 16 16 Pag 5 17 OT Bioelettronica snc User Manual Y 3 elettronica 1 GENERAL DESCRIPTION The Quattro is a 4 channel surface electromyograp
11. nance A VVARRANTY OT Bioelettronica ensures that every nevv product has no defects due to materials and labour and will repair and or replace in warranty products used following the intended use and used in the use conditions described in this manual Warranty lasts 2 years only after filling and signature of the warranty application form that you find below Warranty conditions the obligations of OT Bioelettronica following the warranty are limited exclusively to what follows reparation will be made by and no later than 30 work days after the receipt of the product and only after the verification that the malfunctioning is not due to inadequate or inaccurate use maintenance and or reparation v1 2 Ed 07 2014 Pag 16 17 OT Bioelettronica snc User Manual NS 3 elettronica If OT Bioelettronica verifies that the malfunctioning is not due to inadequate or inaccurate use or unauthorized maintenance reparation the reparation costs materials and labour will be invoiced only after acceptation of the budget of reparation by the owner These warranty conditions substitute all the other warranty conditions explicit or implicit included but not within limits of the general conditions specified in the international sale regulations OT Bioelettronica reserves the right to refuse the reparation of any products sent by the user for reparation this refusal will be conveniently explained The only obligation of OT Bioelettr
12. onditions Temperature from 10 C to 40 C Maximum relative humidity from 30 to 75 Atmospheric pressure from 700 hPa to 1060 hPa It is recommended to turn off the Quattro at the end of every session The Quattro should be stored with all the enclosed accessories on a safe place far from all conditions described in the Warnings section of this manual The Quattro does not need any particular maintenance procedure to work To maintain the battery efficiency recharge the device before every use and check regularly the efficiency status of the battery A If during the use and after the battery charging the battery lasts less than 1 hour contact the manufacturer to check the electrical source itself Cleaning the device At the end of every use please clean the Quattro with a clean cloth A Do not clean the Quattro using acetone ether freon oil products or any other solvent A Do not use soap or vvater on the connectors pin contacts o A Do not clean the Quattro or its cables vvith vvater in autoclave or vvith steam cleaning A VVARNING clean electrodes adapter cable only vvith hospital disinfectants before every use to avoid microbial contamination betvveen patients and healthcare professionals v1 2 Ed 07 2014 Pag 13 17 OT Bioelettronica snc Product Disposal GBO User Manual IZ elettronica The Quattro contains electronic parts that must be disposed of as e waste Dispose the device and the accessories
13. onica is that of returning the product to the user at its own expenses Manufactured by OT Bioelettronica C so Unione Sovietica 312 10135 Torino TO ITALY www otbioelettronica it e mail mail otbioelettronica it v1 2 Ed 07 2014 Pag 17 17
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