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AFT 1000 USER GUIDE
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1. Gnd ground to connect to patient reference electrode 00 OWP Gnd EQUIPMENT PRESENT IN THE PACKAGING In standard configuration the device is delivered with An ECG cable 2 channels 3 leads This manual is in electronic format pdf in the memory of the recorder in the folder Guides The Setup program for Quick Reader Setup exe is present in the memory of the recorder in the folder QuickReader The software has it s own guide Look at if there is a new version of this software on the Download page of Holter Supplies web site An After Sales Service file to fill in case of failure directory SAV The USB2 cable type A mini ref RFU 00A is delivered separately The pouch and lanyard are delivered in separate packaging ref PC T01 0010A or PCTO3 050 A with lanyards PCT05 010 A lll Electrodes placement The electrodes placement except the case of single lead follows the usual Holter recommendations At the end the user verifies the ECG displayed on the screen of the device To ensure a good quality of the recording special care must be taken when preparing the patient s skin placing the electrodes and connecting the leads Gently rub the patient s skin and clean it to obtain a good electrode skin contact and reduce impedance ATTENTION if the patient has a pacemaker use a cable 250 1000Hz RFT0O0 2L3 1000 2L5 1000 or 3L7 1000 and set it to 1000Hz to properly record the pulses ge
2. Affaires Poincare 78 Avenue Raymond Poincare 75116 PARIS France Tel 33 1 47 51 40 04 www holtersupplies com Note These data are indicatives and don t engage Holter Supplies depending of the hardware and software versions several points can change and functioning be different from those indicated We invite the user to verity the functioning of his device with its ECG cables and its battery You can also look at our web site www holtersupplies com 16
3. Last Name First Name 11 Vill Technical specifications ECG features R COTOINON ee bebe ct without compression delta 8 bit optimized 6 GHannel ane dns 1 to 3 channels OF ESO LUO ie de te 12 bit 10uV amp 2 5uV 1000 H Q model e Sampling frequency 250Hz amp 1000Hz H Q Bandpass eee en den dnenee 0 05Hz 80Hz 400Hz H Q 3dB amy amp 001 0 0 gt ana EepEe ee ean he 5 mV e SIONS mener eee ne ean eae Internal flash memory 0 5 to 1 Gigabytes e Spikes of pace maker detection during reading on 1000HZz signal Electrical specifications e nputimpedance ss maniement 40MQ between two poles e COMMON mode rejection gt 60dB from 10 to 120Hz CONSUMPUON nan na lt 3mW mean value SPORE tete 1 x battery 1 5V AAA Environment recording e Battery voltage resolution 10mV 1 measure 10s e emperature ann resolution 0 1 C 3 1 measure 10s e Spatial position Optional acceleration X Y Z 1 measure 10s e Leads impedances permanent measurement Physical DIMENSIONS EAU rind as delns cite bane ied iint rains 41 x 65 x 14 5mm Weight with battery cccccccccccccceeeeseeeseeeeseees 429 MR TCIOSUTO er ee Molded polycarbonate plastic a BEDOV 2 a ne OLED 128x64 pixels Protection against water without pouch IPXO IX Precautions for use and mai
4. The AFT1000 permanently checks the impedance of the cables and the electrodes Channel a More the connection is good higher is the line of impedance Impedance of the channel Threshold The vertical line must be above the threshold otherwise there is a faulty electrode or a cable failure ADVICE BEFORE LET THE PATIENT GO Before to shut down the display the device emits 3 notes to confirm the correct starting of the recording You can verify a last time that the recorder is properly recording press to see the main screen with the turning wheel and if you press a second time you verify the quality of the ECG signal for each channel Your patient can go SECURITY AGAINST DATA ERASING lf during the recording minimum 10mn one stops the recording and restarts it later the recorder displays a restart screen with few right arrows which means a new recording will be set after the previous There is no lost of any recorded data During the reading there will be several sessions separated by stopping intervals The connexion of a USB cable for the transfer of data to the PC reset this security The recorder will start normally SECURITY AGAINST A LOW BATTERY VOLTAGE The recorder measures the battery voltage and detects a drop under a critical value The threshold is fixed at 1 16V The low voltage detection stops the device in full security and the previous recorded data are saved Stop the recorder To stop th
5. ally facing V2 The orange electrode C is placed on V2 ee gs black orange brown blue red green The switch between 250Hz 1000HZ is done in the adjustment screen See chapter V IV Starting the recorder Put the battery Open the battery case at the back of the device Install a new alkaline battery AAA or a rechargeable battery and respect the polarity as indicated in the battery case see below 0459 IPxO mm 7 I Install and close the battery cover until the Index is positioned on O OFF The autonomy is function of the battery voltage for a recorder working around 23 C with 2 channels in standard mode with a moderate usage lt 5 day of the display The NiMH AAA batteries 800mAh give an autonomy of 10 days with a standard 2 channels ATTENTION In normal use don t remove the battery between two recordings If the recorder stands without battery during more than 5 minutes it can loose the date and the time For stopping it during long periods it is recommended to withdraw the battery When it will be power up it will be then necessary to adjust the time and the date Write the patient s name Whether stick a identification label of the patient in the pouch Whether write it with a erasable pen Whether write it in the memory of the recorder p 8 Whether on Quick Reader v 2 03 or and transfer in AFT Connect the patient cable cup E Press the terminal of the ECG
6. cables on the tips of the T k electrodes then insert the connector in the recorder until it is locked by its clip AFT 1 The connector is unplugged by pushing the lever which releases the clip DURATION OF RECORDING days ECG Cable 2tracks 250Hz 2 tracks 1000Hz 3 tracks 250Hz 3 tracks 1000Hz AFT1000 01 A 10d 2d 6d 16d AFT1000 01 B 22d 5d 14d 36d Place the recorder in a disposable protective pouch PCT03 economic amp lanyards PCTO5 The pouch must be changed for each patient Switch on the recorder Put the index on I move the battery cover by pushing the central beam The recorder switches on and displays the main display after a memory check co e LL battery open ia O PS f 4 e IPxO AFT LOGO ST OP I 0 0192MB 036 Normal stop by cover STOP I O Low battery stop STOP V lt 1 16V Message explaining the reason for which the last recording stopped Full memory stop STOP 100 Bad battery contact STOP xi If the ECG connector is not plugged in the recorder displays the screen for time and date adjustment In case of problem a message is displayed see p 9 In case of not start verify that the battery has a enough voltage gt 1 20V ATTENTION If the recording is not launched and without any action during 2 minutes the recorder stops In this case the device is completely halted To restart you need to put th
7. e index on O during around 2 seconds then to put it on I V Menu of the AFT1000 Except the time date and if case the sampling frequency adjustment screen there is not anything to set The only one button to use is the button Display S which commands the next screen in the menu O Main diagram Soa A FT Incorrect Date hour Initialization screen 1000 arno CE Origin of the last stop nd r o Internal check up Si92MB 036 Main screen with D 10 30 10 Recorded duration h 23 07 2012 ECG cable xN or xH Battery voltage Move the cursor with jj h Navigation icons Place the cursor above and push on J available duration x number of channels Graphique display A 10 29 57 Man HAN pla 23 07 2012 LT with impedance bar 2 D 250HZ gt 7 p S Adjust time and date Enter the patient s name Switch 250 1000Hz identif n or birth date EE gt Back to main screen before reaching the 0 Any disconnected channel is advertised by a JL Count down 9 gt 0 Launches recording after 0 Erasing Then erases the memory of the The wheel previous patient turns 14 35 38 Main screen 10s 307 O8 2012 ATTENTION if this screen is during recording 2N 0000 0534 not displayed the recorder has m 30 not started During the recording the button commands the display of the main screen In this case the wheel turns IMPEDANCES MEASUREMENT
8. e recorder at the end of the recording place the index of the battery cover on O The device can also stop spontaneously on low battery voltage a memory full or a bad contact with the battery To clean the recorder see Care of the Device chap IX ERROR MESSAGES During the check up and when the recorder starts several messages can be displayed in case of problem battery voltage too low to record 24h Change the battery hard failure of the flash memory return the recorder to After Sales Services failure of the flash memory which allows to make a recording in the safe part of the memory but the maximum duration of the recording is shorter Verify this duration in the general screen and program a return for repairing VI Data transfer After the device stopped and after setting the index of the battery cover on O you can process to the transfer of the data to a PC under Windows XP Vista 7 which has a minimum of 1 Gigabyte of memory 10 Gigabytes free on the hard disk and a USB 2 High Speed connector see Quick Reader specifications The software Quick Reader must be previously installed you will find the Setup in the memory of the recorder in the directory Quick Reader First remove the ECG connector and plug the USB cable inside the receptacle of the ECG connector Then the screen displays USB 0 0 The last line gt remembers why the recorder stopped last time see p 7 0 0 lf the recorder was not st
9. eflection from structures objects and people 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 AFT1000 is used exceeds the applicable RF compliance level above the AFT1000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the AFT1000 P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Guidance and manufacturer s declaration electromagnetic emissions The AFT1000 is intended for use in the electromagnetic environment specified below The customer or the user of the AFT1000 should assure that it is used in such an environment RF emissions Group 1 The AFT1000 uses RF energy only for its internal function Therefore its CISPR 11 RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The AFT1000 is suitable for use in all establishments including domestic En J Sm establishments and those directly connected to the public low voltage power supply network that supplies buildings
10. m AFT 1000 Et y AFT 1000 Digital Holter recorder USER GUIDE Software version 1 4 CE 0459 r f AM710_GBA4_07F I Introduction The AFT1000 is an ECG Electrocardiogram Holter recorder using an internal flash memory The AFT1000 records 1 2 or 3 tracks of ECG in standard quality 250Hz 10uV or in High Quality 1000HZ 2 5uV The recorded data are transferred via a USB2 High Speed 480Mbauds cable to a PC running the Quick Reader software giving a general overview of the recording and able to analyze it rhythm ST segment elevation QT interval ll General description Connector of the patient cable Graphic display Special surface to Increase the indexed value write patient name option tele transmission button SE LA i vua J opp D AFT 1000 se Display button LE Event marker button Back view with the battery AAA case open Description of symbols present on the case The following symbols are printed on the case of the AFT1000 Indicates that the device is B type IEC 60601 1 Indicates that the user must refer to the AFT1000 users manual before handling the part of the device with this symbol gt gt CE mark the AFT1000 complies with EC directive 93 42 EEC End of live don t throw it away but return it to your distributor eid 3 Manufacturer O Colors of the ECG cables A channel input and B and C channels
11. nect the ECG cable You will find a schema of electrodes positioning in the folder Guide in the memory of the recorder The use of a belt with permanent electrodes simplifies a lot this procedures If the patient temporarily removes the device he shall never switch it off or extract it from the pouch The patient shall contact his physician if the electrodes or the contact with the pouch provoke any skin irritation In case of symptom or for any activity having direct effect on the heart the patient must push on the Event button green the time of the push is then recorded The patient can read the time and the date that are displayed during 5s and report them on his diary sheet with comments The patient should daily make sure that the device is recording If he has not used the Event button he can push on the Display button and verify the display of the main screen with the wheel rotating In case of problem he should immediately contact his physician or the technician The patient must avoid proximity of radio or radar antenna this can perturb excessively the ECG signal It is strongly recommended to print and give to him the eh um Configuration 2 channels 3 electrodes Patient s diary document present in the recorder To do this easily make a copy of this file on the desk you will have just to click on it for opening in a pdf reader and call print COR Sn ivre eus out eus grue y Bs ee PATIENT S DIARY
12. nerated see Adjustment screen chapter V 2 channels recording 3 electrodes Cable RFT00 2L3 250 or RFT00 2L3 1000 Place the electrode with the red connector A over a rib at V5 the electrode with the brown connector B over the xiphoid at the bottom of sternum and the electrode with the white connector common on the manubrium white brown red 2 channels recording 5 electrodes 250 or 1000Hz Cable RFT00 2L5 1000 Place the white connector A on the manubrium and the red connector A over a rib at V5 The black connector B is also placed on the manubrium at the left of the white one and the brown connector B over the xiphoid at the bottom of sternum The Ground electrode with the green connector is placed over a rib on the right side of the chest white black brown red green The switch between 250Hz 1000Hz is done in the adjustment screen See chapter V 3 channels recording 4 electrodes 250Hz Cable RFT00 3L4 250 This configuration is the same as the 2 channels recording 3 electrodes with an antero posterior lead more The blue connector C is placed posteriorly and paravertebrally facing V2 rit 7 white blue brown red 3 channels recording 7 electrodes 250 or 1000Hz Cable RFT00 3L7 1000 lt is the same as the 2 channels recording with 5 electrodes with a CBV2 anteroposterior lead close to the Z axis The blue electrode C lies posteriorly and paravertebr
13. ntenance Transport The AFT1000 is packed in the packaging for delivery lf you want to repack and carry or deliver the AFT1000 after its first usage we recommend putting all the parts back to their initial position End of life When the device is out of order it should be returned to your distributor for appropriate recycling The batteries should be recycled as appropriate ECG cables and pouch can be thrown away since they do not contain specific dangerous material The AFT1000 parts and accessories do not contain mercury nor mercury compounds Conditions for use and storage of the device The following table shows the conditions for use storage and transportation of AFT 1000 Temp rature Humidit Pression Operating 10 to 45 C 10 to 95 700 hPA to non condensino 1060 hPa Storage and 20 to 65 C 5 to 95 500 hPA to Transportation non condensing 1060 hPa During long duration storage few months the battery must be removed from the device The AFT1000 is not protected against chocks from defibrillator the high frequency current and magnetic fields 12 WARNING If a patient wearing an AFT1000 recorder needs to be defibrillated it is mandatory that the recorder s electrodes be removed before the defibrillator is used WARNING The AFT1000 shall not be used in environments with flammable aesthetic mixtures with oxygen or nitrous oxide WARNING The recorder can be disturbed by strong electrostatic discha
14. opped an error message STOP REC is USB displayed STOPS I O lf you must install Quick Reader call the Windows Explorer to find the unit corresponding to the recorder AFT1000 Double click on the folder QuickReader then on the Setup exe program Follow the instructions When Quick Reader is installed you call it by a double click on the icon present on the desktop We recommend to read the manual displayed when you click on the icon The transfer starts when you click on the download icon The transfer is done at a very high rate max 480Mb lf you had written the patient s name on the case enter it in the identification dialog box then erase it with the special eraser The end of the transfer is indicated by a message you must then disconnect the recorder from the USB cable lf you need to make another transfer to another PC it is possible because the data are not erased until a new record starts Avoid intrusions of the PC in the flash memory during the USB download The USB screen displays a closed lock corresponding to a write protect setup of the flash memory There is no more risk to see a virus or a large volume of data writing on the flash memory to compromise the functioning of the recorder In rare cases a spontaneous alteration of the flash memory can occur which impedes Windows to read this memory the download stops with a message as An unexpected error occurs depending of the Window
15. or solvent as alcohol or acetone must not be used Maintenance lf the device doesn t function properly look at the Guide for maintenance in the file of the recorder Never open the device in any case see Warranty You can make a reset of the device in case of failing to work properly or to erase the flag preventing erase of the last record You have access to the reset button through an eye present in the case receiving the ECG connector along the right side at half height Insert a tool paper clip for instance to switch on the reset ATTENTION never make a reset during erasing or recording there is a risk to corrupt the flash memory This reset gives also access to test programs which need special accessories to run However several tests can corrupt the internal memory we recommend to not use these tests if you are not a technician trained to this device 13 X Warranty AFT1000 guaranteed for parts and labour during two years from the date of delivery The accessories as the ECG cables are not guaranteed after their first use After sales service is available after the warranty has expired WARNING the warranty is only valid under the condition that no attempts have been made to open or repair the device or to write or erase the flash memory as virus The warranty will be void if the device or accessories have been used contrary this user s manual recommendations particularly if it is worn without protective p
16. ouch if it receives electric discharges chocks mechanical strain excessive pressure or humidity as defined by the standards applicable to this device CAUTION Federal law restricts the sale of this device by or on the order of a ohysician US only XI Annexe 1 Guidance and manufacturer s declaration electromagnetic immunity The AFT1000 is intended for use in the electromagnetic environment specified below The customer or the user of the AFT1000 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment test level level guidance Electrostatic on USB inputs Floors should be wood concrete or ceramic tile If Discharge ESD 6 kV contact 6 kV contact floors are covered with synthetic material the EC 61000 4 2 8 kV air 8 KV air relative humidity should be at least 30 Electric fast 2 kV for power Mains power quality should be that of a Transient burst Supply lines Non applicable typical commercial or hospital environment IEC 61000 4 4 lines 1 kV input output lines 1 kV differential Mains power quality should be that of a mode Non applicable typical commercial or hospital IEC 61000 4 5 2 kV common mode environment Voltage dips On power Mains power quality the device is powered by a supply input lines N A Non applicable battery IEC 61000 4 11 Power frequency Power frequency magnetic fields 50 60 Hz 3 Alm 3A M should be at levels characteris
17. rges particularly if it is out of its protective pouch A so strong discharge can induce a reset and then stopping the current recording or more a breakdown of the device If a reset occurs the program restarts and the mains screen is displayed as usual The best to do in this case Is to stop the device index on O and to avoid to restart a new recording before download the data to the PC the last data would be erased Electromagnetic compatibility The use of portable and mobile RF communication equipment ex cellular phones radio radar can affect the event recorder since the recorded ECG signal may be disturbed due to electromagnetic interference The device shall not be used in presence of ionizing radiations X rays gamma rays that could cancel the internal memory and the internal flash card Tables about electromagnetic emission and immunity of the recorder are reported in the annex of that manual Care of the device It is advised to test regularly the ECG cables with the tester of cables TCB00 04 A which can be fixed in the suitcase An annual servicing is advised to control functioning of the recorder and to keep it as reliable as possible The pole of the battery must be kept clean Ask to your distributor a maintenance contract The surface of the case and the patient cables can be cleaned with a slightly damp cloth or one wet with soapy water Detergents aggressive products as Dakin for instance
18. s version and language In this case Windows refuses to read memory if it cannot access it in writing mode One can just ask to Start again the reading procedure after gt having open the lock by a push on the blue button as it is indicated 560 on the screen During the download Windows supports error USB correction by modifying the memory configuration Verify after this that the correction doesnt interfere with the internal management by checking the memory of the recorder start gt main screen or time adjust screen STOP I O 10 A sudden hard drive failure can happen Don t forget to secure your download data on the PC create an copy of each record in a second hard disk of the PC internal of external or by write on a flash memory or a DVD with all the last data Vil Recommandations for the patient The patient must be informed of several points The patient should never take any shower or bath while the device is wear This will damage the device The patient shall from time to time take off the device and disconnect ECG cable from the electrodes without switching off the device in order to take a shower or bath one must explain to him how to disconnect the snap fastener without pull the cables If an electrode doesn t stick properly the patient must use a new one so it is necessary to tell him how to position the electrodes give to him enough electrodes for the recording period and tell him how to con
19. tic of a Magnetic field typical location in a typical commercial IEC 61000 4 8 or hospital environment 14 Surge Guidance and manufacturer s declaration electromagnetic immunity The AFT1000 is intended for use in the electromagnetic environment specified below The customer or the user of the AFT1000 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the AFT1000 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 24 P 80 MHz to 800 MHz a VaN d 2 34 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 Radiated RF 3 V m recommended separation distance in metres m IEC 61000 4 3 80 MHz to Field strengths from fixed RF transmitters as determined by an 25 GHz electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and r
20. used for domestic purposes Harmonic emissions Non applicable P RSS Voltage fluctuations flicker emissions IEC 61000 3 3 15 Recommended separation distances between portable and mobile RF communications equipment and the AFT1000 The AFT1000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AFT1000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AFT1000 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter d 1 17VP d 1 17VP d 2334P For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Manufacturer Holter Supplies Centre d
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