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Manuale utente EMG-USB2

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1. 0 pag 15 pag 3 pag 4 AEMG User manual v 11 AEMG User manual v 11 Or 1 GENERAL DESCRIPTION The HEMG is a single channel EMG logger It has been designed to detect surface electromyographic EMG signals together with adhesive concentric electrode CoDe The yEMG allows the detection and recording of the EMG signals generated by human body The single differential signal detected by the CoDe electrode is amplified filtered digitally converted and then stored on a MicroSD card A freeware software called OT BioLab has been designed by OT Bioelettronica and is available for download on the website www otbioelettronica it under the download page 2 HEMG KIT CONTENT 1 amplifier EMG 6 electrode CoDe 4 reference electrode LuEMG user manual 3 END USER The HEMG amplifier allows non invasive recording of single differential electromyographic signals detected by surface CoDe electrode The end user must be familiar with the EMG technique and received a proper training in EMG detection and interpretation Contraindications The HEMG is a battery powered device and has no particular contraindications Side effects No significant side effects are known The materials used for manufacturing all the parts in contact with the patient are biocompatible Possible slight cutaneous allergic reactions e g skin reddening are reduce
2. 0 on the entire bandwidth CMRR gt 95 dB 1 button 57 x 36x 16mm 25 0 pag 14 EMG User manual v 11 Or 10 WARRANTY The HEMG is covered by a 24 months warranty starting from the purchasing date of the electronic parts The warranty is void in case of device violation or in case of intervention from unauthorized staff Warranty conditions are reported hereinafter Warranty conditions 1 The warranty lasts 24 months on the electronic parts Warranty is provided by the manufacturer 2 The warranty covers only device damages that cause malfunctioning The product must have the same serial number indicated on this certificate or the warranty is released 3 The warranty covers only the cost of repair or substitutions of defective components including the costs of labour 4 The warranty is void in case of damages caused by negligence use not compliant with the instructions supplied unauthorized repairs and accidental circumstances especially for the external part 5 The warranty is void with damages caused by incorrect power supply 6 The warranty is not applied on all the parts subject to wear and tear 7 The warranty does not include the shipment costs 8 After 24 months the warranty is released All the substituted parts the labour costs and the shipment costs will be charged to the purchaser according to the rates in force pag 15 EMG User manual v 11 Designed produced and distribu
3. Bioelettronica User manual v 1 1 uEMG Single channel EMG logger This product is manufactured in compliance with the European Standard 93 42 CEE about medical instrumentation and according to the EN 60601 rules for Medical Electrical Equipment pag 2 AEMG User manual v 11 EMG User manual v 11 OT INDEX 1 GENERAL DESCRIPTION n di pag 5 2 PEMG KET CONTENT a EANN pag 5 2 EINEN pag 5 Contraindications pag 5 Side eg pag 5 4 5 5 55 2 pag 6 5 TECHNICAL SPECIFICATIONS la ada daaa vr aaa aaa ni oi a ia ia pag 7 6 DETAILED DESORTPT ON n LAB a IRR RI pag 8 Concentric electrode CODE faves aaa aaa aa aaa dale gelini Galin ne pag 8 Status edu m m n y E pag 9 laan BEE pag 9 MicroSD card la el ala pag 9 Electrode Connector sayan aim nda aram armin aa pag 10 Reference NANSENS pag 10 Z USE OF PEMO en ee ee pag 11 Performing AN ACQUISILION vk eege E aa aaa Ae pag 11 Files UE pag il Battery replacement su saa aza BR EE ee Eege pag 12 8 EMGMAINTENANCEANDSTORAGE pag 13 TECHNICAL CHARACTERISTICS pag 14 10 WARRANTY ini e ine as gal sa pag 15
4. EMG should be stored with all the enclosed accessories on a safe desk far from all the situations listed in the section Warnings HEMG should be stored in the following ambient conditions Temperature from 20 C to 40 C Maximum relative humidity 75 Atmospheric pressure from 700 hPa to 1060 hPa Cleaning use only a dry cloth to clean the device The HEMG should be repaired by the manufacturer only Every repair executed by unauthorized personnel will be considered as a device violation voids the manufacturer s warranty Disposal The device and the accessories should be disposed in compliance with the relative standards in special equipped areas or with special waste pag 13 Or EMG User manual v 11 9 TECHNICAL CHARACTERISTICS Model Classification Case Power supply Consumption Limitations Working conditions Input channels Amplifier Commands Dimensions Weight HEMG battery supplied device IP50 about the penetration of fluids and dust device not protected plastic case 12V MN21 battery 25 mW the device is not suitable for use in environments with high oxygen concentration and or flammable fluids and or gases do not use with electro surgery or short wave microwave therapy equipment device suitable for continuative work 1 channel Maximum input range 3 3 MVpp Bandwidth 10 500 Hz Total noise RTI 3uVems Gain 980 V V Input impedance gt 101
5. ar amplifier and shows a spatial selectivity comparable with the Laplacian system pag 8 EMG User manual v 11 Or which comprises 5 electrodes Higher selectivity implies a lower amount of crosstalk which is one of the main problems in surface EMG recordings Status led The led on the yEMG indicate the device status In table 2 the led condition and the associated status are described Led is OFF The yEMG is switched OFF Led is ON The EMG is in standby No acquisition is running Led pulses every 3 seconds The acquisition is running The battery is low or the MicroSD not correctly formatted It is not possible to start an acquisition Led pulses continuously TAB 2 UEMG status Start Stop button The red button starts or stop the signal acquisition and the data storing on the MicroSD card When the button is pressed a new file is created on the MicroSD card and is closed when the button is pressed again To avoid the creation of large files the EMG automatically close the file when it reach the dimension of 1 MByte after about 17 minutes and open a new file to continue the data acquisition A REMARK Removing the MicroSD card during the signal storing will avoid the file closing The file not closed will be displayed on the PC browser with a dimension of 0 kByte and it will be not possible to recover the data MicroSD card On the left side of the HEMG there is a slot for the MicroSD inse
6. d to a minimum during short duration electromyographic signal acquisitions pag 5 AEMG User manual v 11 4 SAFETY CAUTIONS AND OTHER WARNINGS The use of the HEMG amplifier is forbidden in the following conditions While electro surgery equipment short waves or microwaves therapy devices are used By mentally impaired people Whenever the equipment is damaged In proximity of inflammable substances especially inflammable liquids and gases or in environments with high concentration of oxygen On patients carrying life supporting equipment that might be adversely affected by electromagnetic interferences such as pacemakers etc The following cautions should be observed Only use electrodes supplied by the manufacturer HEMG is guaranteed to achieve tested performance only if used with electrodes supplied by the manufacturer Contact the manufacturer immediately if extraneous materials permeate into the device liquids powders etc In case of hard shocks suffered by the yEMG like a drop to the floor etc verify that no crack or any other kind of damage of the box resulted from the shock In case of doubt please contact the manufacturer The EMG is subject to electromagnetic interference that is not dangerous for the patient such as electrostatic or electromagnetic interference generated by electrical motors and other sources This interference may affect the measurements of the physiological variables derived
7. ect the reference electrode or the reference strap to a point without EMG activity on the subject and connect the clip of the electrode with the clip on the back of the HEMG 2 Place the CoDe on the muscle to investigate and connect the code to the EMG 3 Insert the MicroSD card in the yEMG slot the led will turn on 4 Press once the red button to start an acquisition the led will start to pulse every 3 seconds 5 Press the button again the led will stop pulses and will turn on 6 Repeat the points 4 and 5 all the times you need 7 Remove the MicroSD card and insert it in a card reader on a PC with OTBioLab installed 8 Open the saved files with OTBioLab and process them Files details The files are stored on the memory card with a standard name The name is structured as follow UEMG_FXY EMG Where X is the session counter and Y is the acquisition counter The acquisition counter is incremented every time the start stop button is pressed The session counter is incremented every time the MicroSD card is removed and then inserted Since the two characters can assume the values 1 2 8 9 A B Z it means that up to 36 different files can be acquired in the same session and 36 different session can be created before to obtain two file with the same name It is up to the user to copy the files out of the memory card and delete the files in the card to free the filenames When a file exist on the memory card and a new one with t
8. from the EMG signal These measurements are not meant to be used for diagnostic purposes and thus these signal alterations cannot be dangerous for the patient please always take into account the presence of noise in your signal processing tasks and evaluations The use of the yEMG is restricted to skilled personnel Incorrect measurements can arise when unskilled personnel use the device in presence of strong sources electromagnetic interference e g strong electromagnetic fields The presence of interference in the signals is easily recognised by skilled personnel pag 6 OT 5 TECHNICAL SPECIFICATIONS EMG User manual v 11 The HEMG is a battery powered device designed to guarantee an high safety level for the patient The signal amplified by the instrument is stored in a proprietary file format on a MicroSD card The HEMG technical specifications are shown in table 1 Signal amplification Amplification Gain 980 V V Bandwidth 10 Hz to 500 Hz Maximum input range 3 3 MV pp Noise level referred to input lt 3 uVems Input impedance gt 10 lo CMRR gt 95 dB Output range 0 3 3V Data conversion A D converter resolution 8 bit Storage memory MicroSD Sample frequency 1 kHz TAB 1 EMG technical specification pag 7 EMG User manual v 11 Or 6 DETAILED DESCRIPTION FIG 1 shows controls indicators and connectors present on
9. he same name is created the file is appended to the existing file Since the HEMG does not have an internal real time clock device the date and time of the files will not reflect the real time in which they are generated Although the time and date is generated starting from the 00 00 of the January 197 2010 and is incremented by 1 minute at every new acquisition Sorting the files for the date it is possible to have the file listed in the same order in which they has been created pag 11 EMG User manual v 11 Or Battery replacement The yEMG works with a 12V battery MN21 The battery allows the acquisition of about 8 9 hours of EMG signals When the yEMG led starts to pulse continuously it is necessary to replace the battery To replace the battery it is necessary to open the uEMG The yEMG has no screws just pull the upper and bottom part of the enclosure Remove the previous battery and put the new one Take care about the battery polarity The EMG is not damaged if the battery is inserted in the opposite way but the battery can lose a large amount of charge pag 12 EMG User manual v 11 8 EMG MAINTENANCE AND STORAGE The yEMG has to be used in the following ambient conditions Temperature from 0 C to 40 C Maximum relative humidity 75 Atmospheric pressure from 700 hPa to 1060 hPa It is recommended to turn off the EMG at the end of each measurement session by removing the MicroSD card The y
10. rtion The MicroSD have to be inserted vvith its contacts upvvard In any case it is not possible to insert the card in the opposite vvay Push the MicroSD to insert it and push again to release it The insertion of the MicroSD card switch on the HEMG Removing the MicroSD card the HEMG is switched off Always remove the MicroSD card when the EMG is not used to save the battery pag 9 EMG User manual v 11 Or The MicroSD card must be formatted with standard FAT Formatting the card as FAT32 or NTFS the instrument will not work and the led will pulse continuously to indicate the malfunction N REMARK Use only MicroSD card The HC version will not work with the HEMG Electrode connector The CoDe electrode have to be connected at this circular connector The portion of cable between the HEMG and the electrode connector is shielded to reduce interference coupling Reference clip On the back side of the HEMG a clip connector has a double function The primary function is to fix the voltage reference on the patient the second is to keep mechanically the EMG without the need of tapes It is possible to use a common electrode or a reference strap to electrically connect the HEMG internal reference point with a point on the patient without EMG activity e g the ankle or the wrist pag 10 EMG User manual v 11 7 USE OF pEMG Performing an acquisition To perform an acquisition follow the steps reported here 1 Conn
11. ted by OT Bioelettronica C so Unione Sovietica 312 10135 Torino TO ITALY Tel 39 011 6198498 Fax 39 011 6198498 URL www otbioelettronica it e mail mail otbioelettronica it pag 16
12. the HEMG and described in the following sections Concentric electrode CoDe Ki Status led Start Stop button 4 MicroSD card Electrode connector Reference clip FIG 1 UFMG description Concentric electrode CoDe The CoDe Concentric Detection is an adhesive disposable concentric electrode distributed by OT Bioelettronica The CoDe electrode allows the detection of surface myoelectric signals The geometry of the system a point electrode and a circular ring avoids the problem of the orientation of classic bipolar recordings Moreover the system transfer function approximates a double differential filter which thus provides better spatial selectivity and better reduction of crosstalk with respect to bipolar systems The electrode is available in different sizes depending on the specific application The detection site is made of AgCI and the electrode connector types can be mounted depending on the needs The CoDe electrode is the only system purely isotropic that is invariant to rotations Other systems such as the Laplacian recording approximate the isotropic condition but do not fulfill it The isotropy eliminates the problem of electrode orientation In addition the system provides a two dimensional spatial filtering with selectivity similar or higher than other systems with larger number of electrodes The proposed system only uses two electrodes thus it can be used with any standard bipol

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