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RT3 Manu 6 GB

1. eene eene ee terrenis 70 12 MAINTENANCE nn ee race NE a 71 12 1 ANDEING THEE OUIPMENT j ed Ebene ee een 71 12 2 XZEBANING THE EQUIPMENT a een 71 123 REPLACING THE BACK UP BATTERY un ae din 71 12 4 STORAGE AND DISPATCHING anni ee 71 12 5 USER PRECAUTIONS Gesendet 42 TGs IWIN TENANCE Sr M M Ni nie en ae ten 12 I2 PREVENTIVE MAIN PENANG Eire caren tats nt nern T2 12 8 INORMS AND SAFETY STANDARDS sa EE EH Pes eM ISIN PE INE 74 129 JECHNICAD DA ss nennen 75 12 10 SPECH CAT ON Sees ee ee DER eter ass 75 12 11 ACCESSORIES AND CONSUMABLES ecce hene nee enn enne e een nenne 76 RT User Manual 6 GB 14 May 2004 Contents page 6 R TEST EVOLUTION Contents RT User Manual 6 GB 14 May 2004 page 7 R TEST EVOLUTION Contents RT User Manual 6 GB 14 May 2004 page 8 R TEST EVOLUTION 1 Introduction The R Test Evolution and the R Test Evolution II and 3 are miniature ECG event recorders quick and easy to place on the patient They store the most important pathologic events symptomatic or silent as well as the patient s continuous heart rate and 1s capable of up to eight days ambulatory recording The system consists of a unit weighing about 40 grams and a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort The R Test Evolution is connected to the patient by a system of electrodes and a neck cable Events stored by the R Test Evolution are then tra
2. Put the electrocardiograph into the manual continuous recording mode Start up the Decotest by pressing its key which will light up Let the patient know that he will have within about 10 seconds to do the following Press the key real time ECG transmission or the M key transmission of the memory until he hears the modulated signal Bring his telephone microphone close to the R Test Stop the audible signal by pressing the same key as soon as the transmission of the recording 1s finished Put the telephone earphone on the Decotest rubber cradle Run the ECG paper The transfer will stop automatically after 5 minutes if the patient has not stopped it himself and the R Test will switch back to its initial recording mode RT User Manual 6 GB 14 May 2004 page 55 R TEST EVOLUTION Telephonic transmission RT User Manual 6 GB 14 May 2004 page 56 R TEST EVOLUTION Modem transmission 10 Modem transmission The information recorded by the R Test Evolution II or 3 can be transmitted via modem from any standard network telephone socket to a remote computer also connected into the telephone network by modem This mode of transmission differs to the standard R Test transmission system telephonic transmission by acoustic coupling in that it allows the transmission of all the information graphs heart rate curve dates and times tables rather than just the graphs and 1s ten time
3. set off the recording by pressing the centre key for about 1 second with his index finger making sure that the R Test is held in this position for the whole recording which ends with a beep RT User Manual 6 GB 14 May 2004 page 38 R TEST EVOLUTION How the unit works 6 How the unit works When the R Test ready to start has been connected to the patient follow the instructions for the mode you have chosen continuous or discontinuous RT User Manual 6 GB 14 May 2004 page 39 R TEST EVOLUTION How the unit works 6 1 Start up and start up test in the continuous mode 6 1 1 6 1 2 solid gel electrodes only Continuous mode about 8 days solid gel electrodes only The R Test continuously analyses all QRS It will record automatically or manually and recordings contain a pre event and a post event duration The R Test goes into the continuous mode automatically when solid gel electrodes are used It can however if required be forced into the discontinuous mode even if solid gel electrodes are used otart up in the continuous mode Press the centre key of the unit to start The R Test will emit a continuous audible signal for 6 seconds then emit a signal modulated by the patient s ECG for 20 seconds enabling any problems in the ECG detection to be picked up immediately If necessary use the Decotest to carry out a more detailed test described below with measurements and visualization of the si
4. Accessory Reference Packaging Special batteries Zinc Air 1 4 V ACC 0706 00 Box of 60 batteries V 5 patient cable standard 30 cm RTSoft software for PC LOG 0001 00 pack NovaDrive software LOG 0500 00 Applications CD NovaMail software LOG 0500 00 Applications CD NovaModem software LOG 0500 00 Applications CD R Test Decotest user manual this manual LOG 0500 00 Applications CD R Test Decotest quick reference guide ACM 0201 0x l item RTSoft manual LOG 0500 00 Applications CD NovaDrive manual LOG 0500 00 Applications CD x language 1 French 2 English 3 German 4 Spanish 5 Portuguese 6 Italian For the Decotest Accessory Reference Packaging Det DTE DTE 0001 00 00 dunt unit RT User Manual 6 GB 14 May 2004 page 76 R TEST EVOLUTION Maintenance RT User Manual 6 GB 14 May 2004 page 77 R TEST EVOLUTION 0459 RT User Manual 6 GB 14 May 2004 page 78
5. R Test Evolution R Test Evolution ll R Test Evolution 3 User Manual English NOVACOR S A 4 passage Saint Antoine 92508 Rueil Malmaison Cedex France R Test Evolution Manual 2001 2004 NOVACOR SA All rights reserved RT User Manual 6 GB 14 May 2004 page 1 RT User Manual 6 GB 14 May 2004 page 2 R TEST EVOLUTION Contents R Test Evolution R Test Evolution II R Test Evolution 3 ls JINTRODUCIION sa 9 25 GUARANTEE ge a RUE RM dn RE EIER e E ip 11 54 OPERATION 43 nn hr UI MSAN MM MANN MM IT EIE 13 4 DESCRIPTION OF THE EQUIPMENT 20us8ua08 aan 25 35 CONNECTING IHE PATIENT susanne 3l 6 HOW THE UNIT WORKS portenta en anna 39 Te PATIENT INSTRUCTION ans nis 43 DOWNLOADING THE RESULTS 58 2082 Bra Bi 47 9 TELEPHONIC TRANSMISSION na 53 10 MODEM TRANSMISSION 2 400022 Rag Ue se ee iiaae 57 11 E MAIL TRANSMISSION sccccssssassssssssscsoscsseasseocdsccsscsssssvaasvecseseansssasecdsassscsnsesese 67 12 MAINTENANEE 0a 71 RT User Manual 6 GB 14 May 2004 page 3 R TEST EVOLUTION 1 INTRODUCTION A A ee nn m tastes tint sente AVETE 9 1 1 ABOUT THIS MANUA a acca sh Ast MAR E E 10 1 1 1 Gonera S weiss an ats TOR TES 10 1 2 REMOTEUSERS Lernen 10 EZER Resulis sent Dy MON RS Cone aa aoa 10 1 2 1 2 Isesults sent Dy inall nee een een ee 10 GUARANTEE ERR ets Mens E vx MS Messa tUe lit nie 11 AE SPECIFIC GUARANTEES CONCERNING UNITS sssccccecesseccceeeesecceeeausecceeeua
6. This check up must be carried out in the Novacor or a Novacor recommended workshop The invoicing covers the tests only no repair work can be carried out unless a written order has been received from the customer RT User Manual 6 GB 14 May 2004 page 72 R TEST EVOLUTION Maintenance Problem Possible Cause When the unit is started up The unit is in the Change the batteries pressing the centre key does safeguard mode and reinitialise the not work R Test Impossible to read the The unit is in the Change the batteries R Test safeguard mode without reinitialising the R Test The memory is empty following a reinitialisation of the unit The memory is empty For a new patient because no recordings reinitialise the unit have been made The Decotest luminous Batteries are flat Change the batteries button does not light The Decotest luminous Batteries are starting to Change the batteries button is blinking run down The electrocardiographic Electrode skin contact is Change the noise Telephonic transmission re O O O The electrocardiographic Activate the filter rejector filter has been deactivated The R Test alarm rings The electrode alarm has Change the every quarter of an hour been activated electrodes If the unit is disconnected the alarm will stop when it is reinitialised The start up test does not Le R Test is too far away Bring the R Test 10 work from the Decotest cm away from the Decotest RT U
7. This operation must be carried out very carefully so as not to damage the unit nor the cable Training beforehand is essential To disconnect the cable from the unit the connector must first be unlocked do not pull using brute force the unit could be damaged D Press the two faces of the connector marked PRESS and 2 pull straight until clear as indicated in the picture above RT User Manual 6 GB 14 May 2004 page 69 R TEST EVOLUTION E mail transmission 11 5 Connecting the R Test to the R Test PC cable The connector must fit into the R Test according to the symbol shown on the interior of the connector NOVACOR R Test and connector connected correctly 11 6 Disconnecting the R Test PC cable To disconnect R Test from cable After having turned over the R Test connector it is necessary to D press firmly on the serrated part of the connector using the thumb and forefinger before 2 releasing the R Test from the connector RT User Manual 6 GB 14 May 2004 page 70 R TEST EVOLUTION Maintenance 12 Maintenance 12 1 Handling the equipment Always press the centre of the keys never use finger nails or a pointed object The R Test recorder is dust proof and water resistant complies to norm 60 601 1 protection level IPX4 It should never be immersed in water Nevertheless it 1s recommended not to keep it to take the shower If the unit is sprinkled with water wipe it
8. Connecting The stermalelecttOde s o e e et n delere 35 5 6 2 2 Connecting the cervical electrode zn ire es sn eri ice oe taces 36 5 6 3 CMS configuration with solid gel electrodes 36 5 6 3 1 Placine the electrodes ied ro Eee He des ide eol s ee 37 5 6 3 2 Connecti the Ie T ESEL sioe en seen 37 5 6 4 Configuration with metal electrodes nnneenn 38 HOW THE UNIT WORKS 39 6 1 START UP AND START UP TEST IN THE CONTINUOUS MODE cene 40 6 1 1 Start up in the continuous mode 40 6 1 2 Visualisation of the test SIGNAL iere tee rates 40 6 1 2 1 Visualisation on an electrocardiograph uueeeeeeeeeeeeeeeeeeeenneseeeeeeeeeeeeeeeeeenn 41 6 1 3 DUSCOHWOCUOR IOSE da det ea Ale cea M IA cs 41 6 2 START UP AND START UP TEST IN THE DISCONTINUOUS MODE 42 PATIENT INSTRUC LION 2 emailen 43 7 1 GENERAL COMMENTS ei uma NN sn NI idR 44 2 ACTIVATING A MANUAL RECORDING een nnn nn 44 7 2 R Test Evolution with solid gel electrodes 44 16822892 R Test Evolution with metal electrodes see 44 uos REMOVING THEIR TEST VOLUTION nee einen 45 7 4 FAULIY EUECTRODECONNECHION ei 45 DOWNLOADING THE RESULTS a essen au uns 47 8 1 REMOVING THE R FPES Tee en NER rennen 48 a ENTON VCC OV ANNO anerkennt 46 8 1 2 Temporary interruption of recording eesssss ee 46 8 1 2 1 Disconnects he Clee EOS iod carie Lo deci dee poe
9. There is a ridge around the recording key so that it can easily be used even through a shirt Place the unit against the chest pulling it downwards so that the metal electrode 1s in contact with the skin at the level of the sternum This operation also ensures that the neck electrode is properly connected and in the right position Keep holding the unit in this way and press its centre key briefly The unit will then emit an audible signal indicating that the recording has been set off The R Test must be kept pressed against the chest for the whole duration of the recording without being jerked as this could produce noise on the recording The R Test indicates the end of the recording by another audible signal Inform the patient of the pre programmed recording duration RT User Manual 6 GB 14 May 2004 page 44 R TEST EVOLUTION Patient instruction 7 3 Removing the R Test Evolution The patient may need to take the unit off in order to wash or to change faulty electrodes To remove the unit Disconnect the sternal electrode and the neck or V5 electrode keeping them held against the skin with one hand and pull the R Test or the cable connector with the other be careful not to damage the electrode or pull it off Take the R Test system off as 1f it were a necklace the unit should not be separated from the neck cable 7 4 Faulty electrode connection If there is a faulty electrode connection electrode unstuck faulty
10. ref ACC 0158 01 can be used with most computers The Decotest is necessary however for a start up test on the screen connecting the R Test to an electrocardiograph computers that are not compatible with the cable RT User Manual 6 GB 14 May 2004 page 29 R TEST EVOLUTION 4 3 R Test Evolution accessories RT User Manual 6 GB 14 May 2004 Equipment l Neck cable tous modeles 2 V5 cable 30 ou 60 cm RTE et RT II 3 Suspension cable RTE et RT II Nota 2 et 3 are progressively replaced by 7 4 Solid gel electrodes 5 Adhesive patches for electrodes 6 Metal electrodes 7 CMS cable for R Test 3 standard 40 cm or long 57 cm usable with all models in place of n 2 and 3 page 30 R TEST EVOLUTION Connecting the patient 9 Connecting the patient The R Test Evolution 1s usually connected to the patient using solid gel electrodes with the Neck Sternum lead although another lead such as CMS can be preferred If the physician only wants to obtain manual recordings with no pre event duration the unit can be worn loose around the patient s neck In this case the patient holds the R Test Evolution through his clothes against his skin during the recording The patient 1s connected as described below for standard cases solid gel electrodes For manual recordings with no pre event duration the metal electrodes supplied with the unit are used
11. 2004 page 43 R TEST EVOLUTION Patient instruction 7 1 General comments The R Test can be worn all day and all night without any special precautions The patient can carry on with his normal activities including sports if he is fit The R Test is dust proof perspiration proof and water resistant but showers and baths must not be taken by a patient equipped with an R Test If he wants to have a bath or shower he can remove the R Test unit but should leave the electrodes in place If however they become too wet they may have to be changed 7 2 Activating a manual recording 7 2 1 7 2 2 The patient can set off a recording whenever he feels a symptom as long as this was authorised when the unit was programmed Manual recording can be explained to the patient at the end of the start up test twenty seconds later he can activate a recording himself which can be used as a reference during final analysis of the procedure R Test Evolution with solid gel electrodes Press the centre key briefly and the unit will emit an audible signal indicating that the recording has been set off Another shorter audible signal will indicate the end of the recording this is just for the patient s information he is not required to do anything else R Test Evolution with metal electrodes Hold the R Test on each side between the thumb and the middle finger through the clothes or directly if the clothes are too thick to hold the unit
12. 6 GB 14 May 2004 page 51 R TEST EVOLUTION Downloading the results 8 3 3 Order of transfer Recordings are transferred either chronologically to the electrocardiograph or if the Arrhythmia and or ST options have been installed classified by type of event in the following order Narrow premature isolated complexes 2 to 5 narrow premature complexes Narrow runs Wide premature isolated complexes 2 to 5 wide premature complexes Wide runs Relative pauses Absolute pauses Bradycardias Manual recordings ST shifts Recordings are separated by an easily recognised square signal Separator Event Separator 2 Events separator Recordings may have a supplementary marker symptomatic event marker in the shape of a short line of triangular waves indicating the moment when the patient pressed the centre key of the unit whilst a recording was already in process Event Symptomatic event marker RT User Manual 6 GB 14 May 2004 page 52 R TEST EVOLUTION Telephonic transmission 9 Telephonic transmission R Test Evolution patients can transmit recordings by telephone either the contents of the unit s memory or the patient s real time ECG to the physician or an analysis centre This function available as standard on all R Tests must be programmed to be activated RT User Manual 6 GB 14 May 2004 page 53 R TEST EVOLUTION Telephonic transmission 9 1 How the telephonic transm
13. R Test so as to not damage the equipment R Test PC cable RT User Manual 6 GB 14 May 2004 page 68 R TEST EVOLUTION E mail transmission 11 4 Removing the R Test 11 4 1 End of recording If the R Test monitoring is not to continue after data transfer removal of the unit is not difficult Patient s skin can then be dried or cleaned with soap and a clean cloth following any instructions given by the physician 11 4 2 Temporary interruption of recording It is possible then either to proceed as above and after the transfer the electrodes are replaced with new ones or let the electrodes in place on the skin disconnect the patient cable neck cable or V5 cable from its electrode then disconnect the R Test from the sternum electrode then unplug the cable from the R Test with the V5 cable the suspension cable will not be disconnected form the R Test 11 4 2 1 Disconnecting the electrodes Cable electrode with a finger on each side of the press stud press firmly on the neck cable electrode and with the other hand lift up one side of the connector to remove it from the press stud of the electrode R Test electrode place a finger on each side of the press stud of the sternum electrode and lift up one side of the unit until it clicks out of the electrode This way the R Test and the cable can be reconnected to the same electrodes as they have not been removed 11 4 3 Unplugging cable from R Test
14. be held upside down with the front plate key side turned towards the operator Insert the R Test vertically into the Decotest hatches which open automatically Guide the unit manually into the connectors and continue pushing it vertically until it is fully engaged 8 2 3 Transfer of data to a computer This 1s fully explained in the RTSoft software manual RT User Manual 6 GB 14 May 2004 page 50 R TEST EVOLUTION Downloading the results 8 3 Transfer to an electrocardiograph 9 3 1 8 3 2 Connection Introduce the banana plugs into the same colour connectors of the Decotest Turn on the electrocardiograph in the continuous recording mode Turn on the electrocardiograph in the continuous recording mode Acoustic transfer If a computer is not being used the contents of the R Test memory are transferred acoustically to the electrocardiograph Put the R Test unit in the rubber cradle of the Decotest with the front plate visible Press the Decotest key its luminous button will light up Start running the ECG paper and simultaneously press the M key of the R Test to start up the transfer The electrocardiograph prints the events recorded during the monitoring period on ECG paper the dates and times of these events should be supplied by the patient When the transfer is finished stop the ECG recorder and do not forget to switch off the Decotest by pressing its key again RT User Manual
15. continuously processed and analysed and the most significant pathological events are saved in the unit s memory Each recording includes the ECG immediately preceding and following the event the durations of which are programmed by the physician Real Time Transmission The ECG only is transmitted in real time in the form of a modulated acoustic signal to the physician s surgery or a reception centre The reception equipment is in general a Decotest linked to an ECG monitor or to an electrocardiograph Real time transmission can be programmed by the physician when he is connecting the patient who can then activate it as many times as necessary After transmission the R Test automatically goes back to its pre programmed mode RT User Manual 6 GB 14 May 2004 page 15 R TEST EVOLUTION Operation 3 3 Manual Recording This mode is designed for symptomatic patients for whom a per critical ECG recording is required even if this symptom only occurs occasionally The patient simply has to press the R Test recording key and the ECG recording will then be saved in the unit s memory This recording is stored without being analysed or interpreted so that the physician can examine it later on 3 4 Automatic Recording 3 4 1 The R Test monitors the ECG signal continuously and stores it in a loop memory which therefore contains at any given moment the previous few minutes of the ECG recording this means that a given duration
16. errors or inaccuracies which may be found in this manual NOVACOR may change the functions of the devices or their accessories without prior notice 1 2 Remote users This manual is obviously made for the use of the main R Test user who is generally unique In some cases units are managed by users who in collaboration with another centre deal with fitting and removing the R Test but do not interpret the recordings carried out These remote users transfer then patients data to the interpretation centre either by modem or by e mail The practical details of such operations are given in specific chapters which can be printed separately and given to these remote users 1 2 1 1 Results sent by modem Chapter 10 3 pages 61 to 65 can be printed and given to a remote user physician or patient who will have to send results by modem 1 2 1 2 Results sent by e mail Chapter 11 pages 67 to 70 can be printed and given to a remote physician who will have to send results by e mail RT User Manual 6 GB 14 May 2004 page 10 R TEST EVOLUTION Guarantee 2 Guarantee NOVACOR undertakes to deliver merchandise conforming to the technical specifications mentioned and to replace any merchandise recognised as being defective during the period of garantee RT User Manual 6 GB 14 May 2004 page 11 R TEST EVOLUTION Guarantee 2 1 Specific guarantees concerning units NOVACOR guarantees the unit recorders and Decotest fo
17. medical personnel to guarantee its proper use t should only be fitted to patients aware of the unit and capable of understanding recommendations given to them and able to take action if necessary to stop the recording The R Test is an ambulatory recorder and has no monitoring functions no alarm system in particular It should not then be used for monitoring 12 6 Maintenance If the unit is not working properly first consult the table on next page This should be able to help in most cases Maintenance is carried out in our workshop as rapidly as possible We are unable however to provide a unit on loan during the repair period except under special agreement or to provide compensation of any sort In all cases including units under guarantee transport costs are the customer s responsibility If the unit is examined outside the guarantee period there will be at the minimum a charge for administrative and testing costs On receipt of the unit diagnostic tests will be carried out and an estimate will be sent by post or by fax 1f appropriate No repair work can be carried out unless a written order has been received from the customer 12 Preventive maintenance A check up of the recorder is recommended every two years This is to reduce the number of problems and to prolong its useable life The unit will be checked that it functions correctly especially the ECG amplification circuits and the back up battery
18. of the ECG preceding a detected event can be included in the recording This duration called the pre event can vary from 5 seconds to four minutes Filtering external noise The difficulty in making an accurate automatic analysis of an ECG recording is often due to interference caused by different factors which may distort the signal significantly The R Test and its patient cable possess specialised sensors capable of identifying most of these noises as they appear and rejecting the invalid part of the signal Interference is thus removed making analysis of the ECG signal much more efficient RT User Manual 6 GB 14 May 2004 page 16 R TEST EVOLUTION Operation 3 5 Automatic analysis of the ECG 3 9 1 3 9 2 The ECG recording is analysed in real time by the R Test as the ECG signal is stored in the loop memory the R Test s microprocessor uses specific software and algorithms to automatically carry out the following operations QRS identification and elimination of noise QRS morphology and width measurement R R interval and basal heart rate calculation continuous memorisation of the heart rate recognition and hourly counting of arrhythmic events memorisation of selected episodes with date and time shown Basal heart rate The reference R R interval which corresponds to the basal heart rate is obtained by continuous calculation of the average of the last R R intervals recognised by the R Test
19. of waste Never use an R Test if the casing is damaged cracked or broken to avoid any risk of electric shock NOVACOR has electronic plans of the devices available on demand RT User Manual 6 GB 14 May 2004 page 74 R TEST EVOLUTION Maintenance 12 9 Technical data Overall width 33 mm Weight with batteries 320g 12 10 Specifications Type of recorder Automatic ECG event and Heart Rate trend recorder Manual ECG event recorder Type of events Premature fine and large QRS automatic mode isolated multiplets and runs Absolute and relative pauses Bradycardias ST shifts Length of events automatic mode Programmable from 10 s to 20 min with pre event mini 5 s maxi 4 min and post event mini 5 s maxi 19 min 55 s loop memory manual only mode pre event 0 post event 30 s or pre event 20 post event 10 s Total length of recording ECG events 20 min Heart rate trend 8 days Maximum length of monitoring automatic mode 8 days manual only mode 2 months Electrical supply zinc air batteries 1 4 V 600 mAh Number of channels Data storage RAM solid memory Sampling 100 Hz Precision of ECG in voltage standard initial signal lt 3 mV 6 UV 3 mV lt initial signal lt 6 mV 12 uV RT User Manual 6 GB 14 May 2004 page 75 R TEST EVOLUTION Maintenance 12 11 Accessories and consumables The following accessories and consumables are available from your supplier For the R Test
20. systole The R Test uses a point on the base line 20 ms before each QRS complex as the reference level for the ST shift 3 6 2 The beginning of the ST segment The beginning of the ST segment J point is identified by the R Test on the ECG signal 10 ms after the end of the ORS complex being analysed 3 6 3 The ST segment The ST segment used for measuring the slope connects the J point to an ST point situated 60 ms later on the ECG signal 3 6 4 Measurement of the ST shift The ST shift is measured at the M point situated 30 ms after the J point of the ECG signal 10 5 mV s 3mm Example of ST shift 3 6 5 Detection criteria An ST change can be recorded by the R Test if the shift is greater than the pre programmed threshold value and slope is less than the pre programmed threshold value for 30 seconds To construct histograms the R Test calculates the mean ST shift and slope for each group of 30 QRS complexes and retains the highest shift observed every 16 minutes RT User Manual 6 GB 14 May 2004 page 20 R TEST EVOLUTION Operation 3 Consecutive events 3 7 1 Single events pre event 2 ln Recording n 1 EE Recording n 2 Single events In general two consecutive events detected by the R Test are sufficiently far apart from one another for their recordings to be separate These two events are therefore two single events 3 2 Chained events pre event 2 post even
21. C under Windows must be equipped with a modem connected to the telephone network preferably an external modem connected to the computer s serial ports However an internal modem or a PCMCIA modem drive for laptops would be suitable a receiving software unit NovaModem supplied by Novacor an RTSoft software version 1 11 0 or above with the Modem Communication option installed RT User Manual 6 GB 14 May 2004 page 58 R TEST EVOLUTION Modem transmission To transmit via modem the receiver s computer must be on with the NovaModem software in Stand by mode remote user connects the R Test to the modem then presses the M button on the R Test Once the transmission is finished the remote user can continue the recording by reconnecting the R Test as it was before the transmission 35 Whilst the physician s modem is awaiting reception of an R Test procedure no other information should be sent to him An attempt to connect will suspend the Novacor stand by and no other information can be received anyway It is strongly advised to use this modem exclusively for reception of R Test procedures 10 2 Equipment Equipment given to the remote user 10 2 1 The recorder R Tests with the modem transmission feature have serial numbers beginning with RTM In these units the High and Low Alarms in the Frequency 30 option have been removed They can be used as normal without taking int
22. S ee ee qr oboli od pin nie ei ACE 21 3 7 1 Sinele PONS A ETE E E EE NAI AE AE ee im 21 3 72 Chained CONS eee ed bn ele sive en 21 3 7 3 WDE EVENS ETI TEE ET dem deis T Or cts trate athe 22 3 8 MEMORISATION OF EVENTS bananes e tet od miss ele tu evt ada etes 22 3 9 USING THE R TEST EVOLUTION WITHOUT A COMPUTER suisses 23 DESCRIPTION OE THE EQUIPMENT sentis 25 4 THE R TEST EVOLUTION RECORDER 0ccccessecccessececaeeccecusecceseecceeaeeceeeueeceeaes 26 4 2 CO NECHION ee ee eo ae cou 24 4 2 1 LICE DL AN RS CP 27 4 2 2 Descripiton of the D cCOtes ta dede e tte e eoo inde 26 4 2 3 Changing the Decotest batteries 28 4 2 4 Lhe R Lole C COO O EE 29 4 3 I TEST EVOLUTION ACCESSORIES Ener 30 RT User Manual 6 GB 14 May 2004 Contents page 4 R TEST EVOLUTION 5 CONNECTING THE PATIENT ur AR 31 5 1 ORDER OF CONNEC TION arora iera A n EE EEA E 32 2 CHOICHOPLBAD en aan ee 32 324 Neck Sternum configuration sai isti acea a na on caesus 32 To CMS CON EUFO OW uoto E EET E T s 32 se INSERTING NEW BATTERIES Se nt ne 32 5 4 INITEALISING THE DEUM E 33 5 4 1 With Compiler eisernen 33 3 4 2 DU 211700 hte e ee ar PEE 33 5 5 CONNECTING THE PATIENT CABLE TO THE R TEST 0 cccccccccecccceeeeeeeeeeeeeeeeeees 34 5 6 PLACING THE ELECTRODES AND CONNECTING THE R TEST nn 34 5 6 1 TCD AVALON NH 34 5 6 2 Neck Sternum configuration with solid gel electrodes 35 5 6 2 1
23. and let it dry If the unit is immersed in water wipe it and send back to Novacor for verification 12 2 Cleaning the equipment AN As the R Test may be in direct contact with patients skin it will need to be cleaned regularly To proceed to device cleaning it 1s necessary to keep a patient cable connected to the R Test in order to avoid any inside contamination with cleaning product This should be done with a soft cloth lightly moistened with alcohol or a product which does not contain solvents or detergents preferably with the cable connected Avoid direct contact with liquids The Decotest and the cables can be cleaned in the same way 12 3 Replacing the back up battery The lithium back up battery is necessary for the R Test to work at it s best When this s run down the recorder s serial number is no longer displayed and there will be a risk of losing data It can only be replaced in a NOVACOR approved workshop If this should happen contact your distributor who will explain what to do 12 4 Storage and dispatching If the R Test is going to be stored for more than a few days make sure that the batteries have been removed When the R Test and Decotest are dispatched they are protected by their packaging which should be kept in case it is needed RT User Manual 6 GB 14 May 2004 page 71 R TEST EVOLUTION Maintenance 12 5 User precautions The equipment must only be used by qualified R Test trained
24. as being normal The R R intervals recognised as being abnormal 1 e periods containing noise pauses and intervals preceding and following premature QRS complexes in order to also eliminate compensatory pauses are therefore excluded from the calculation of the mean interval By default this calculation is made from the last 8 R R intervals recognised as being normal Special case of runs when a run which is defined as 6 successive premature QRS complexes has been identified its rate becomes the reference rate This facilitates identification of the termination of a run by the relative lengthening of the first normal R R interval which follows Memorisation of the heart rate At regular intervals the R Test stores 3 values enabling assessment of the patient s heart rate trend to be made mean rate maximum rate and minimum rate The duration of this interval is chosen according to the length of time that the patient will be connected to the unit In addition to recording pathological events the R Test therefore also provides the physician with continuous monitoring of the mean maximum and minimum heart rates for a period of up to eight days maximum basal heart rate defined above RT User Manual 6 GB 14 May 2004 page 17 R TEST EVOLUTION Operation 3 5 3 Detection of arrhythmias Arrhythmias detected by the R Test are classified in the following categories 3 5 3 1 Rapid arrhythmias premature QRS c
25. be switched on at the time of transmission and more results from all R Test Evolution models are compatible RT User Manual 6 GB 14 May 2004 page 67 R TEST EVOLUTION E mail transmission 11 1 Operation The R Test is connected to the remote physician s computer via a cable connected to a serial port The NovaDrive software whose main function is to program Novacor ambulatory recorders without the full corresponding software is installed with its E com option on the remote physician s computer The remote physician simply downloads and saves the recordings using the NovaDrive software He can thus re use the R Test immediately either on the same patient continuation of current procedure or on a new patient after changing the batteries and if necessary the programme patient name included still using NovaDrive The receiving computer in an analysis centre for example must have RTSoft software version 1 12 or above with the E mail option and NovaMail specific software for Email reception 11 2 The NovaDrive and NovaMail software Use of NovaMail is described in the RTSoft manual and NovaDrive in the NovaDrive Manual 11 3 The R Test PC connection cable The R Test PC cable has two connectors The PC serial port end can be identified by the PC sign Make sure the instructions given in the following chapters 11 5 and 11 6 are followed when connecting and disconnecting the other end to the
26. contact R Test disconnected and the electrode alarm is activated the unit will emit an alarm signal every 15 minutes until the problem has been corrected If the patient is of a nervous disposition let him listen to the alarm when you are connecting the unit and reassure him that this is a completely harmless incident To correct the electrode fault the patient can press the electrodes back into place If the problem is repetitive the electrodes should be changed as follows Take the R Test off as explained above Take the electrodes off having very carefully taken note of their positions Clean the skin to eliminate any perspiration or gel and make it dry Place the new electrodes on the skin in exactly the same positions as before RT User Manual 6 GB 14 May 2004 page 45 R TEST EVOLUTION Patient instruction RT User Manual 6 GB 14 May 2004 page 46 R TEST EVOLUTION Downloading the results 8 Downloading the results When the patient brings the R Test Evolution back the physician has immediate access to the recordings in its memory As with the tests when the unit is connected the recordings can be transferred either to an electrocardiograph or to a computer on which the RTSoft software has been installed version 1 11 0 minimum for the R Test Evolution II or 3 In both cases transmission can be made via the Decotest For transmission to a computer with Windows the most common a direct cable connect
27. e are hatches for connecting the R Test a luminous button and a rubber cradle for acoustic transmissions The following connectors are located on the back plate Four standard connectors for the patient cable of an electrocardiograph Each connector is identified by a colour and the same colour banana plug of the patient cable is inserted into it A computer connector DB9 type for using the R Test with RTSoft software with the cable provided A lateral connector allowing the Decotest to be plugged into an external power supply 6 V DC such as a mains supply charger instead of using batteries The luminous button is used for starting and stopping the Decotest only when it 1s used with an electrocardiograph or an ECG monitor When the Decotest is connected to a computer this button is inactive as the software starts up the Decotest automatically It therefore only lights up during transfers 4 2 3 Changing the Decotest batteries When the batteries start running down the luminous button will start to blink The batteries should be changed immediately To do this open the battery cover under the Decotest and insert four R6 AA batteries taking care not to invert the polarities RT User Manual 6 GB 14 May 2004 page 28 R TEST EVOLUTION Equipment 4 2 4 The R Test PC cable R Test PC cable The Decotest 1s not always necessary for connecting the R Test to a computer the direct connection cable
28. ed to the PC serial port can be used Recordings can also be transmitted from a distance either by the patient himself or by a collaborating physician either to a medical centre or to an analysis centre Teletransmission of recordings by telephone modem or by E mail is described in the following chapters 9 to 11 RT User Manual 6 GB 14 May 2004 page 47 R TEST EVOLUTION Downloading the results 8 1 Removing the R Test 8 1 1 8 1 2 End of recording If the R Test monitoring is not to continue after data transfer removal of the unit is not difficult Patient s skin can then be dried or cleaned with soap and a clean cloth following any instructions given by the physician Temporary interruption of recording It is possible then either to proceed as above and after the transfer the electrodes are replaced with new ones or let the electrodes in place on the skin disconnect the patient cable neck cable or V5 cable from its electrode then disconnect the R Test from the sternum electrode then unplug the cable from the R Test with the V5 cable the suspension cable will not be disconnected form the R Test 8 1 2 1 Disconnecting the electrodes Cable electrode with a finger on each side of the press stud press firmly on the neck cable electrode and with the other hand lift up one side of the connector to remove it from the press stud of the electrode R Test electrode place a finger on eac
29. eeeceees 12 2 2 SPECIFIC GUARANTEES CONCERNING ACCESSORIES suisses sense eene 12 2 94 RESTRICTIONS OF THE GUARANTEE sisi eene nennen nennen nenne senes 12 2 4 RESPONSIBILITIES sen een 12 2 9 UPGRAD S CE 12 2 6 OOP VGN Ses Sexes at mp dM PIE LC E QE 12 OPERATION Aon RSR Si it id see ia ess 13 3 1 COLLECTING THE ECG SIGNAL Ss ns 14 3 2 RECORDING MODES standen animal 15 3 2 1 Manual VECO AI seis eie Sts cicada et a ence pepe ee 15 3 2 2 AWOME VOC ONIN NN De 15 3 2 9 Real lime Transmission o aec dar ANNE nr are ts 15 3 3 WEAN UAT RECORDING onere oec oe ER P epi ER see 16 3 4 AUTOMATIC RECORDING ses eek 16 3 4 1 Fierin ternal NOISC sans neueste 16 39 AUTOMATIC ANALYSIS OF THE ECG sis 17 3 5 1 Basal Near TV IC whe een NE Rte Ne sh te ua UE 17 323 25 IMemoris tion of the heart rate 17 3 5 3 Detection of arrhythmidS acsi sees dde oto ei apt enda scthastanis itas 18 3 95 93 1 Rapid arrhythmias premature QRS complexes and runs 18 333 2 ABSOLUE DANSE S232 oa sou Si et Me ee ee 18 3 5 3 5 Iselattve pause Sess ceste nc Atc ee 18 3 5 3 4 Bradyc alias sr el else ctt c cnet tees ed ee es 18 3 5 4 Unc P 19 3 6 ST SBEGMENT NAT Y SIS Cd die tee M epos ia ed tese Dee 19 3 6 1 DAS DT E C 20 3 6 2 The beginning of the ST segment 20 3 6 3 TNEST Seesen nee Eu 20 3 6 4 Measurement of the ST Shift 20 3 6 5 Dete ct los cel esit eret r sente E niet ei eau 20 Su CONSE CUM EVEN
30. es If the batteries are flat they should be replaced just before the R Test is initialised for a new patient so that it can function for the longest possible time The special R Test batteries enable the unit to function for more than a week in the automatic detection mode with all its options activated Make sure that the new batteries have been inserted before initialising the unit Taking the batteries out afterwards before start up of the R Test will freeze the clock as long as the batteries remain removed after start up of the R Test switches the unit into the Safeguard mode and blocks it from functioning until it has been reinitialised RT User Manual 6 GB 14 May 2004 page 32 R TEST EVOLUTION Connecting the patient Lift the handle and turn it a 4 of the way round in either direction RTE and RT ID or unlock battery cover R Test 3 Take the old batteries out by turning the unit over Take the adhesive strip off the new batteries Put them in taking care not to invert the polarities The side back of the batteries should be pointing upwards Put the battery cover back in place Turn the handle 1 4 of the way round to lock the cover back in place or check that battery cover is properly locked R Test 3 The R Test will then go through a 6 second battery check at the end of which you will hear a two tone signal 9 4 Initialising the unit 9 4 1 With a computer This consists of p
31. est to the electrocardiograph by putting the peripheral banana plugs of the patient cable of the electrocardiograph into the Decotest connectors of the same colour Press the Decotest button which will light up then turn on the electrocardiograph A single channel model is preferable This should be used in the continuous recording mode manual mode generally in D1 lead for models with a selector active filter If however a multi channel model is used only the D1 lead will be taken into consideration As soon as the R Test Evolution starts up a 20 second ECG recording is obtained which should be as clear as normal with a peak to peak amplitude of the QRS complexes of at least 1 millivolt Disconnection test If the disconnection alarm has been programmed recommended disconnect the unit or the neck electrode for a few seconds to activate it and explain what it means to the patient The warning signal will be emitted every 15 minutes by the R Test until the problem has been resolved for example by replacing an electrode which has come unstuck or has dried up the patient should be provided with an extra set of 2 electrodes in case he needs them RT User Manual 6 GB 14 May 2004 page 41 R TEST EVOLUTION How the unit works 6 2 Start up and start up test in the discontinuous mode with solid gel or metal electrodes Discontinuous mode about 2 months solid gel or metal electrodes In this mode recordings are activa
32. g key is inoperative During the whole time it is connected to the patient the R Test also memorises hour by hour the total number of events detected for each pathology whether they are memorised or not This enables tables or event histograms by pathology to be established for the whole monitoring period 3 9 Using the R Test Evolution without a computer In such basic version the automatic mode is not available and so only manual recordings can be made The R Test memory is restricted to 5 minutes enabling 10 manual recordings of 30 seconds each to be made During its test phase explained in 6 the R Test automatically identifies the electrode configuration used by measuring the impedance between them If it identifies solid gel electrodes 1 e a permanent electric connection the recordings will have a pre event duration of 20 seconds and a post event duration of 10 seconds otherwise the 30 second recording will be attributed to the post event duration i e from the moment the patient sets off the recording Once the physician has transferred the recordings to his electrocardiograph he can then delete the contents of the memory by pressing the initialisation push button RT User Manual 6 GB 14 May 2004 page 23 R TEST EVOLUTION Operation RT User Manual 6 GB 14 May 2004 page 24 R TEST EVOLUTION Equipment 4 Description of the equipment For optimum use under all circumstances the R Test Evolution uses var
33. gnal After this period of 20 seconds the recording begins and the R Test will emit a beep synchronized with each QRS complex detected If the ECG signal is not visualized see next perfect synchronization of the beeps with the pulse rate for at least 30 seconds 1s the best guarantee that the voltage of the lead configuration chosen is sufficient gt 1mV In the automatic mode this check 1s absolutely necessary to ensure accurate detection If it 1s negative check the connections and or change to the CM5 lead configuration Recording has begun so press the centre key again to stop the beeps and allow manual recordings Visualisation of the test signal The signal collected during the acoustic phase of the start up test can be visualised using the Decotest The direct connection cable allows only audible verification and checking the beep pulse synchronisation as described above is thus essential RT User Manual 6 GB 14 May 2004 page 40 R TEST EVOLUTION 6 1 3 How the unit works The modulated audible signal emitted by the R Test is picked up by the Decotest when the patient moves near it this is transformed into an electric signal which can be examined either on a computer screen explained in the RTSoft software manual oronan electrocardiograph paper recording or an ECG monitor depending on the options chosen by the physician 6 1 2 1 Visualisation on an electrocardiograph First connect the Decot
34. h side of the press stud of the sternum electrode and lift up one side of the unit until it clicks out of the electrode This way the R Test and the cable can be reconnected to the same electrodes as they have not been removed 8 1 3 Unplugging cable from R Test This operation must be carried out very carefully so as not to damage the unit nor the cable Training beforehand is essential To disconnect the cable from the unit the connector must first be unlocked do not pull using brute force the unit could be damaged D Press the two faces of the connector marked PRESS and 2 pull straight until clear as indicated in the picture above RT User Manual 6 GB 14 May 2004 page 48 R TEST EVOLUTION Downloading the results 8 2 Connection to a computer 8 2 1 Using the direct cable RS232 only 8 2 1 1 Connecting the R Test PC cable The connector must fit into the R Test according to the symbol shown on the interior of the connector R Test and connector connected correctly 8 2 1 2 Disconnecting the R Test PC cable To disconnect R Test from cable After having turned over the R Test connector it is necessary to D press firmly on the serrated part of the connector using the thumb and forefinger before 2 releasing the R Test from the connector RT User Manual 6 GB 14 May 2004 page 49 R TEST EVOLUTION Downloading the results 8 2 2 Using the Decotest The unit should
35. instead of solid gel electrodes and generally the Neck Sternum lead is used although occasionally the Neck V5 lead will be preferred Other differences are specified where applicable RT User Manual 6 GB 14 May 2004 page 31 R TEST EVOLUTION Connecting the patient 5 1 Order of connection Choice of lead nserting new batteries nitialising the unit Connecting the patient cable to the R Test Placing the solid gel electrodes on the patient and connecting the R Test Start up and start up test 5 2 Choice of lead 9 2 1 DUE Neck Sternum configuration This lead which gives very good quality ECG signal especially generally with clear P waves requires the use of the Neck Sternum patient cable ref ACC 0105 00 It must be chosen to perform manual only recordings discontinuous mode with metal electrodes on symptomatic patients see 5 6 4 p 38 CM5 configuration In some cases the Neck Sternum lead will not be chosen particularly if the QRS amplitude is inadequate A preliminary decision can be made by examining the surface ECG If the peak to peak amplitude of the QRS in V2 is less than 1 mV it is best not to use the Neck Sternum lead and to choose for example the CMS lead instead The CMS lead may also be used for analysis of ST segment changes or if there are problems with the patient s sternum CMS is the standard lead with R Test 3 unit 5 3 Inserting new batteri
36. ious different accessories connection to a computer only or to a computer and or an electrocardiograph programming and reading in the same place or for example programming in one practice and reading n another teletransmission of data or not for teletransmission of data choice of telephone e mail or modem for the R Test Evolution II and 3 RT User Manual 6 GB 14 May 2004 page 25 R TEST EVOLUTION Equipment 4 1 Ihe R Test Evolution recorder Before R Test Evolution 3 Connector Memory transmission Real time key transmission key Start manual recording key Manual initialization push button Battery cover lock substituted with a clip on R Test 3 R Test 3 battery cover locking clip RT User Manual 6 GB 14 May 2004 page 26 R TEST EVOLUTION 4 2 Connection Equipment 4 2 1 The Decotest RT User Manual 6 GB 14 May 2004 D RS232 Connector output to computer ECG Connectors output to electrocardiograph Rubber cradle Off On light connection to a electrocardiograph or Communication light connection to a computer Socket for connection to R Test Microphone for acoustic reception and start up test page 27 R TEST EVOLUTION Equipment 4 2 2 Description of the Decotest The Decotest enables the recorder to communicate with a computer an electrocardiograph or an ECG monitor On the front plate ther
37. ission works R Test Evolution patients can transmit recordings by telephone as many times as necessary These may be either the contents of the unit s memory ECG recordings identified and classified by pathology in the R Test memory or the patient s real time ECG the ECG signal can be received by an electrocardiograph As telephonic transmission is the modulation of an acoustic signal only the ECG can be transferred analogical signal The Decotest receives the signals transmitted by telephone transcribes them and transfers them to the electrocardiograph 9 2 Patient action The patient telephones the physician or analysis centre normally Once the reception equipment is set up the transfer can take place The patient presses the M button to transfer the contents of the R Test s memory Or Presses the button for real time transfer of the ECG Pressing the button again will stop the transfer The handset should be held very near the R Test but not touching risk of noise The real time ECG transmission will stop after 5 minutes but can be repeated as often as necessary RT User Manual 6 GB 14 May 2004 page 54 R TEST EVOLUTION Telephonic transmission 9 3 Physician s action If not already done upon receiving the call from the patient Connect the electrocardiograph to the Decotest by connecting the peripheral banana plugs of the patient cable to the Decotest connectors with the same colours
38. letely disappeared before placing electrodes on him again and take any other precautions that you consider necessary The patient s skin must be carefully prepared before fitting R Test electrodes shave the area if too much hair wipe with ether briefly if excessive sweating A light scrub or shave helps a good contact between the electrode and the skin RT User Manual 6 GB 14 May 2004 page 34 R TEST EVOLUTION Connecting the patient 5 6 2 Neck Sternum configuration with solid gel electrodes Neck sternum configuration 5 6 2 1 Connecting the sternal electrode LT Sternal electrode Sternal electrode plus adhesive patch Place the sternal electrode first on the lower third of the sternum if possible or in any case as low as possible if the patient s chest 1s particularly large 35 Adhesive patches must be used to make sure that the solid gel electrodes adhere properly especially for patients who perspire heavily or who will be connected to the R Test for more than 24 hours These adhesive patches have been developed so that they can be used both with the sternal electrode use centre hole and with the cervical electrode use off centre hole RT User Manual 6 GB 14 May 2004 page 35 R TEST EVOLUTION Connecting the patient 5 6 2 2 Connecting the cervical electrode u SS re un a4 EE Cervical electrode Cervical electrode plus adhesive patch Put the R Test and cable a
39. nsferred for interpretation either by a decoder the Decotest to an electrocardiograph or an ECG monitor or to a computer or by cable directly to a computer This transfer is generally done at the physician s surgery at the following visit It can also be teletransferred by phone or e mail or by modem for the R Test Evolution II or 3 either from the patient s home or from the office of a physician working in connection with an interpretation centre The R Test Evolution can also transmit real time ECG recordings by telephone and after reading or transmission the R Test Evolution can continue recording any further pathological events which may occur on the same patient Using a computer enables you to define the conditions and criteria of the recordings to be made by the R Test Evolution to select organise and store the results of a procedure and to print them in customized reports RT User Manual 6 GB 14 May 2004 Introduction page 9 R TEST EVOLUTION Introduction 1 1 About this manual 1 1 1 Generalities This manual concerns R Test Evolution all models inclusive R Test Evolution 3 It describes the way they work and the way to use them It also contains technical data and indicates when particular attention is required Especially all specific precautions and safety norms are indicated in chapter 12 Although it has been redacted very carefully NOVACOR accepts no responsibility for any
40. o account the modem transmission function RT User Manual 6 GB 14 May 2004 page 59 R TEST EVOLUTION Modem transmission 10 2 2 The modems 10 2 2 1 Receiver Modem Any modem found commercially would be suitable as the receiving modem 10 2 2 2 Remote user Modem The transmitting modem must be able to use the R Test communication system Novacor holds a list of compatible modems selected from those most commonly found available for users The modem must have the EC mark 10 2 3 The software R Tests are driven programming reading etc by the RTSoft software To receive recordings by modem version 1 11 0 or above with Modem option is required Also a specific Novacor software for modem reception NovaModem must be installed on the receiving computer Obviously versions 1 11 0 and above of RTSoft can be used with the whole R Test Evolution range 10 2 4 Ihe R Test Modem cable The R Test Modem cable has two connectors The modem end can be connected to the modem before being given to the remote user In order to avoid any risk of damage to the equipment make sure this one knows how to properly connect and disconnect the other R Test end cf 10 3 4 and 10 3 5 1 The R Test Modem cable RT User Manual 6 GB 14 May 2004 page 60 R TEST EVOLUTION Modem transmission 10 3 Remote user participation 10 3 1 What the remote user has to do The remote user must carry out the transfe
41. o around two minutes depending on the amount of data to be transmitted finally three beeps followed by one long beep are given out indicating that the transfer 1s finished and that the data has been successfully received by the remote computer The remote user can then disconnect the R Test from the modem cable and turn the modem off 10 3 5 1 Disconnecting the R Test Modem cable To disconnect R Test from cable After having turned over the R Test connector it is necessary to D press firmly on the serrated part of the connector using the thumb and forefinger before releasing the R Test from the connector RT User Manual 6 GB 14 May 2004 page 64 R TEST EVOLUTION Modem transmission 10 3 5 2 Turning off the modem If as is normally the case the remote user does not have another modem transfer to carry out in the near future it is advised to turn the modem off switch found on the modem In the event that the remote user is not going to re use the modem at all he can unplug it completely including the electricity and plug in his telephone as before 10 3 5 3 Continuation of monitoring 10 3 5 3 1 Reconnecting the cable If the remote user is to continue with the R Test monitoring he must first of all reconnect his cable neck or V5 D place the cable connector opposite that of the R Test so that the two red positioning triangles are facing each other 2 gently push the cable connecto
42. oae dese or idet es dtc eo edet 48 8 1 3 Unplugging cable from R Test eee 46 8 2 CONNECTION TOA COMPUTER essen entsperren 49 8 2 4 Usinge the direct cable RS2 gt 2 0n nasse 49 8 2 1 1 Connecting the R Test PO eable aieo a eei dinde 49 82 1 2 Diseonnecting the R Test PC cable u Ze tenet 49 8 22 Cine Ihe Decotest san aaa lee 50 8 2 3 Transfer of data lo d CODIDUleE sco te cau eda e aan 50 8 3 TRANSFER TO AN ELECTROCARDIOGRAPH ccccccccccssccceesssssseeeeescceceesessaeaeeessees 5 8 3 1 CONNEC HON Ester S 51 8 3 2 P SOIT AYITSR TNT UOI T2 TON ODE S 51 8 3 3 Order OF TANS OF ARR TENE cS 22 TELEPHONIC TRANSMISSION 2 53 9 1 HOW THE TELEPHONIC TRANSMISSION WORKS ssssseeececceceeeeeeeasseeseseseseeeeees 54 9 2 PATIENT ACTION sedeat es iiM id eu ctt dec Le teo a es I edis 54 33 PHYSICEANAS ACTION east dent etoile 55 RT User Manual 6 GB 14 May 2004 Contents page 5 R TEST EVOLUTION 10 MODEM TRANSMISSION aeo va Seo e avene pens roo ean rae esa na da a Ea eO eu Crea eoa nac oe ea obe 57 10 1 OPERATION seele sts esse 58 102 BEODIENIEN TES ee a oat en OE US ce LOS n 59 10 2 1 VII 2714 07 17 CR nee er ROTER ee 59 0 22 LR MOACNS LS RER OT ee Beine 60 10 2 2 1 Receiver Modens ene OR n omo seele 60 19222 Remoteuser VLOG CI een 60 PODS INE SOMWOTE aden ists serien 60 10 2 4 The R Test Modem cable au ala 60 10 3 REMOTE USER PARTICIPATION Se eite eed bas n das ole
43. omplexes and runs A QRS complex is considered to be premature if the R R interval preceding it is shorter by a given proportion standard program 25 than the reference interval mean rate The R Test classifies QRS complexes according to their width Narrow premature QRS complexes QRS less than 120 ms Wide premature ORS complexes QRS 120 ms or more their organisation Isolated QRS complexes Multiples 2 to 5 consecutive premature QRS complexes Runs 6 or more consecutive premature QRS complexes This form of identification enables the R Test to distinguish six sub groups of rapid events Isolated premature narrow QRS complexes Narrow multiples Narrow runs Isolated premature wide QRS complexes Wide multiples Wide runs 3 5 3 2 Absolute pauses These are characterised by an R R interval exceeding a certain duration standard program 2 0 seconds irrespective of the QRS morphology whether or not this R R interval is consecutive to a premature QRS complex 3 5 3 3 Relative pauses These are characterised by an R R interval exceeding a given percentage of the mean reference R R interval standard program 175 providing that it does not follow a premature QRS complex and that its duration is shorter than the absolute pause threshold 3 5 3 4 Bradycardias These are characterised by a reference heart rate lower than the pre defined threshold standard
44. on cable to the handle of the battery cover and connect the V5 cable as indicated for the neck cable In this configuration the R Test is worn upside down and is hung around the neck by the suspension neck cable Put the suspension cable around the patient s neck The R Test should now be upside down with the V5 cable hanging downwards Click the R Test onto the sternal electrode and then connect the cable to the corresponding electrode in the V5 position CM5 cable Plug the CM5 cable into the R Test as indicated before for the neck sternum cable put the spiral support part around the patient s nack then click the R Test onto the sternal electrode and the distant connector to the corresponding electrode in the V5 position RT User Manual 6 GB 14 May 2004 page 37 R TEST EVOLUTION Connecting the patient 5 6 4 Configuration with metal electrodes Connect the neck cable to the R Test then click one metal electrode into the neck cable connector and the other one into the back of the R Test Put the system around the patient s neck making sure that the cervical electrode 1s correctly applied to the skin To make a recording the patient should either directly or through his clothes hold the R Test on each side between his thumb and middle finger pull it gently downwards whilst pressing the unit to the skin at the level of the sternum or where applicable at V5 level so that there is a good electrode skin contact
45. program 50 bpm RT User Manual 6 GB 14 May 2004 page 18 R TEST EVOLUTION Operation 3 5 4 Definitions Type of event Definition detection threshold standard program Premature QRS RR mean RR 25 9o complexes and runs narrow or wide Narrow QRS Normal QRS complexes supraventricular m 120 ms ventricular in some cases Wide QRS Ventricular or pathological QRS iN or gt 120 ms Relative Pause R R interval exceeding a given percentage RR gt 175 x mean RR of the mean reference R R interval Absolute Pause R R interval exceeding a given duration RR gt 2 0 sec Bradycardia Reference heart rate lower than pre Mean FC lt 50 min defined threshold Manual recording The R Test record button is pressed EE 3 6 ST segment analysis The ST segment is characterised by its slope with reference to the beginning of the segment J point this may be ascending zero 0 or descending This is expressed as millivolts per second mV s its shift in relation to the base line this can be positive elevation or negative depression It is measured in millimetres mm the ordinate scale being mV cm 30 ms 4 60 ms 4 location of measurement points RT User Manual 6 GB 14 May 2004 page 19 R TEST EVOLUTION Operation 3 6 1 Base line The base line or the iso electric line represents the electric level of the ECG signal after a diastole and before the next
46. r into the R Test until their locking into place can be felt This operation similar to that described above 10 3 4 for connecting the R Test to the modem cable must be shown to the remote user beforehand 10 3 5 4 Replacing the R Test on the patient If the previously used electrodes had been removed they must be replaced with new ones and new patches if necessary Then and this applies also when having taken off the R Test without removing the electrodes simply click the R Test onto the sternum electrode after having slipped the suspension cable or the R Test and cable around the neck then the opposing connector onto the other electrode The continuation of the monitoring is immediate and automatic RT User Manual 6 GB 14 May 2004 page 65 R TEST EVOLUTION Modem transmission RT User Manual 6 GB 14 May 2004 page 66 R TEST EVOLUTION E mail transmission 11 E mail transmission Transmission by electronic mail or E mail is principally aimed at physicians who in collaboration with another centre deal with fitting and removing the R Test but do not interpret the recordings carried out It is a useful alternative to modem transmission as it passes via the Internet and requires no specific material or connections Of course both the sending and the receiving physician must have a computer equipped with a messaging software Another advantage is that the receiving computer does not have to
47. r of the contents of the R Test modem himself He must learn the following manipulations beforehand check the modem is correctly connected and turned on remove the R Test connect it to the modem transfer the recordings disconnect the R Test and the modem turn off the modem if necessary put the R Test back on It goes without saying that the physician must be sure that the remote user knows how to carry out these manipulations correctly so as to avoid any risk of damage to his equipment and ensure correct transmission of procedures 10 3 2 Modem connection To avoid additional handling the modem can be given to the remote user with the R Test cable already plugged in 10 3 2 1 Telephone connection If the remote user has a telephone socket available the modem telephone network cable can be plugged in directly As a general rule the patient should unplug his telephone from the wall socket connect the modem telephone network cable in it s place and then reconnect the telephone into the back of the modem telephone jack in the wall This connection enables the use of either the telephone or the modem but never both at the same time RT User Manual 6 GB 14 May 2004 page 61 R TEST EVOLUTION Modem transmission 10 3 2 2 Mains connection The remote user must plug the modem electric cable usually with a transformer into a mains electricity socket Before using the modem the remote user m
48. r the period of one year from the date of delivery against any defect resulting in an abnormal function of the unit 2 2 Specific guarantees concerning accessories Equipment which is not categorised as a unit in particular the accessories and cables 1s not covered by the guarantee 2 3 Restrictions of the guarantee The guarantee does not apply to units repaired or opened outside our workshop to units damaged by negligence by accident or because the instructions in the user manual have not been correctly followed If necessary contact your distributor or our maintenance service We do not accept units which have been returned without prior agreement 2 4 Responsibilities NOVACOR will not under any circumstances be held responsible for physical or material damage of whatever nature resulting either directly or indirectly from improper use of the unit or from failure to follow the instructions in the user manual Although NOVACOR manufactures products to the highest standards justifying customer confidence it cannot guarantee or be responsible for the validity or accuracy of the measurements made with its units Therefore connection of the unit to the patient interpretation of the ensuing clinical results and the diagnosis established from them are the entire responsibility of the physician No damage either direct or indirect resulting from the use of one of its units can be attributed to NOVACOR excluding the
49. rally optimal P wave amplitude However the physician may prefer to use a different lead to the neck sternum such as the CMS lead for which there is a specially designed cable The CMS lead may be chosen in the following cases when the amplitude of the neck sternum lead is insufficient when the anatomy of the patient s sternum makes it impossible to connect the R Test properly when the main aim is to record ST changes The R Test stores significant ECG events in its memory The physician can pre program the duration of these events and the mode in which they will be recorded automatically for asymptomatic problems according to recognition criteria specific to each pathology or by patient activation pressing the recording key for symptomatic or silent events whether they be cardiac or not RT User Manual 6 GB 14 May 2004 page 14 R TEST EVOLUTION Operation 3 2 Recording modes 3 21 322 3 28 The physician can select one two or all three of the following recording modes depending on which software options he has installed Manual recording The ECG is recorded by the R Test for a pre determined duration each time the patient presses the unit s recording key but is not analysed or processed Each recording includes the ECG immediately preceding and following the event the durations of which are programmed by the physician Automatic recording The ECG signal is
50. ree de ts 61 10 3 1 What the remote user has to do 61 10 3 2 Modem COMO CUI ON ecu c sete M reed 61 10 3 2 1 Telephone Connection ice oe ei entes ctis e deseo cte eite decl beu ca ee ese 61 10 3 2 2 MAINS CONNECTION ee usus lent else 62 10 33 sdXemovine The Test area 62 10 3 3 1 bud CONN ec sd Mesa sen ae a ne iut 62 10 3 3 2 Temporary interruption of recording 62 10 3 3 3 DisconneeinscheR Test cable Anne ine in tiene 63 10 3 4 Connecting the R Test to the modem cable 65 10 3 5 Transfer of recordings une rer ui ae 64 10 3 5 1 Disconnecting the R Test Modem cable 64 10 3 5 2 Turn ns olf the mode naar et eoe eee teu ees Aes 65 10 3 5 3 Continuation of monitoring 65 10 3 5 4 Replacing the R Test on the patient 65 11 E MAIL TRANSMISSION 2 00 67 jd de OPERATION Ss Seelen ee 68 11 2 THE NOVADRIVE AND NOVAMAIL SOFTWARE ceeensssennsssennssennnsennnsnnnnnnnnnnnennnnn 68 11 3 THE R TEST PC CONNECTION CABLE eeeeessssseessnnssssnsennnnssnnsnnnssenennnessensesennn 68 Dl REMOTING THER TES ARS dE epu eM AP a pna ENS ae neo 69 PLA BR Of TECON us dts ey as tia nie ee tl eeu teca 69 11 4 2 Temporary interruption of recording 69 11 4 2 1 Disconnechns the elect tOde s oda e D e t edid iius 69 11 4 3 Unplugging cable from R Test eene 69 11 5 CONNECTING THE R TEST TO THE R TEST PC CABLE enm 70 11 6 DISCONNECTING THE R TEST PC CABLE
51. repair of the unit within the limits of the guarantee 2 9 Upgrades All customers duly registered with NOVACOR or where applicable with one of its distributors will be kept informed to the best of NOVACOR S ability of any upgrades to the R Test Evolution system as they become available 2 6 Copyrights Manuel R Test Evolution 3 2004 Novacor S A All rights reserved R Test Decotest RTSoft and their respective logos are registered trademarks of NOVACOR SA Windows is a registered trademark of Microsoft Corporation RT User Manual 6 GB 14 May 2004 page 12 R TEST EVOLUTION Operation 3 Operation Le R Test Evolution 1s an ambulatory automatic or manual single channel ECG event recorder for asymptomatic or symptomatic patients RT User Manual 6 GB 14 May 2004 page 13 R TEST EVOLUTION Operation 3 1 Collecting the ECG signal The surface ECG signal is recorded with a bipolar lead between two ECG electrodes specially adapted for the R Test The unit is connected directly to one of the electrodes on the patient s sternum The second electrode which is placed behind the patient s neck is connected to the R Test by a polyurethane neck cable which automatically adapts itself to the patient s size and shape The neck sternum lead enables an ECG signal to be recorded with a QRS morphology and amplitude comparable to V2 significantly different right and left ventricular activations gene
52. rogramming the R Test for a new patient see the Programming section in the RTSoft software manual 9 4 2 Manually Press the R Test initialisation push button with for example the tip of a biro until the unit emits a series of beeps This will delete any recordings left in the R Test memory RT User Manual 6 GB 14 May 2004 page 33 R TEST EVOLUTION Connecting the patient 9 9 Connecting the Patient Cable to the R Test When the Neck Sternum lead has been chosen the neck cable should be connected to the R Test before it is placed on the patient so that the solid gel electrodes can be correctly placed R Test cable connection Make sure that the connector is lined up with the R Test so that the logos of the connector and the front plate are visible at the same time Guide the connector into the unit until it is locked into position 5 6 Placing the electrodes and connecting the R Test 9 6 1 Preparation Novacor recommends the exclusive use of the specially selected electrodes for R Test monitoring which are supplied in sealed pouches These electrodes are hypoallergenic Ag AgCl and can normally be worn for several days without any side effects However people with sensitive skin may have an allergic reaction rashes spots etc These reactions will usually disappear spontaneously after a few days when removing the electrodes If the patient s skin is particularly sensitive wait until the rash has comp
53. round the patient s neck without attaching the unit to the sternum and let them hang naturally against the cervico thoracic spine Locate the place where the neck electrode will be applied round electrode put it in place then stick the adhesive patch over it popper through the off centre hole Click on the neck electrode and click the R Test onto the sternal electrode 5 6 3 CM5 configuration with solid gel electrodes Avec Neck cable et V5 cable With new CMS cable CMS configuration RT User Manual 6 GB 14 May 2004 page 36 R TEST EVOLUTION Connecting the patient 5 6 3 1 Placing the electrodes Lr SE Sternal and V5 electrodes plus adhesive patch This is connected in the same way except that the sternal electrode is placed higher up on the sternal manubrium ideally at the angle of Louis Then place the electrode in V5 as indicated 5 6 3 2 Connecting the R Test In this configuration instead of the neck sternum cable you will use either the V5 cable and its suspension cable or the CMS cable supplied in standard with the R Test 3 and which will finally replace V5 and suspension cables 35 Please note that the V5 cable is available upon demand in two sizes standard about 30 cm and Jarge about 60 cm Also for the CMS cable standard about 40 cm delivered with the unit and large about 55 cm upon demand V5 cable plus suspension cable Attach the spiral support cable suspensi
54. s faster The Modem transmission was designed to be carried out by the patient himself however it could also be done by a doctor in connection with an analysis centre who fits and removes the R Test but does not analyse the recordings RT User Manual 6 GB 14 May 2004 page 57 R TEST EVOLUTION Modem transmission 10 1 Operation Modem transmission of R Test recordings can be done either by the patient him self from his home orby a physician who in collaboration with a cardiology centre fits and removes the R Test but does not interpret the recordings This person physician patient or whoever will be referred to as the remote user during this chapter Modem teletransmission The addressee of the modem transmission will be referred to as the receiver Modem transmission can only be carried out using R Test units whose serial number begins with RTM The remote user receives in addition to the R Test unit and its standard accessories a modem which must be connected to the telephone network analogic network 1f there is no free line the remote user must disconnect his telephone connect the modem and reconnect the telephone in the back of the modem Jack the mains electricity via the transformer delivered with the modem The remote user will also receive a cable permanently connected to the modem to connect the R Test to when transmitting the memorised information Also the receiving computer P
55. ser Manual 6 GB 14 May 2004 page 73 R TEST EVOLUTION Maintenance 12 8 Norms and safety standards A A CEM R Test Evolution R Test Evolution II and R Test Evolution 3 work exclusively with an internal power source and comply with class BF device protection standards This sign on a unit indicates that extra information 1s available in the user manuals which should be consulted The use of special batteries 1 4v zinc air enables the R Test to run for more than a week in the automatic detection mode with all its options activated Using the R Test with other types of batteries may result in loss of performance or reduce the length of time it will function for and may even damage the unit Consequently our guarantee does not apply if batteries other the recommended ones have been used Equipment connected to the Decotest or to the R Test Evolution must comply to the EN 60 950 standard and the EN 60 601 standard for external supply to the Decotest When using external supply to the Decotest batteries must be removed The R Test Evolution and the R Test Evolution II and 3 comply to the EN 60 601 1 2 electromagnetic compatibility standard However use under certain specific conditions may be effected by disturbances CE mark conform to the 93 42 CEE European Directive applied to medical devices Dispose out of date or unusable products and accessories following regulations and laws for the disposal
56. t 1 pre event 1 recording n 2 Chained events Two consecutive events will be chained if the interval separating them is less than the duration of the post event of the first pre event of the second and the second event occurs after the post event of the first They will be classified normally in their specific categories and in addition identified as links n 1 and n 2 of chain n x The recording of the second event will have the pre defined pre event post event duration of its category but it will start after the end of the post event duration of the first Note that the following event may also be added to the chain if it fulfils the above criteria as there is no restriction to the length of a chain It will then be recorded in its own category and identified as link n 3 of chain n x RT User Manual 6 GB 14 May 2004 page 21 R TEST EVOLUTION Operation 3 3 Multiple events pre event 1 post event 1 Multiple Events Multiple events When two consecutive events are such that the second occurs within the post event of the first the second will not be recorded separately However when the second event is an absolute pause or a run i e at least 6 consecutive premature QRS complexes worse than the previously memorised worst absolute pause or run the recording of this double event will be attributed to the special multiple event register 3 8 Memorisa
57. ted manually by the patient and only contain a post event duration To put the R Test into the discontinuous mode if you do not use a software program the following instructions should be carefully followed Press the centre key and remove the unit from the patient s chest essential for forcing the unit into discontinuous mode The R Test will emit a continuous audible signal for 6 seconds during which the unit must be kept held away from the patient s chest for at least 3 seconds Place the unit against the sternum gently pulling it downwards if metal electrodes are being used or connect it if solid gel electrodes are being used Listen for the audible signal modulated by the ECG about 20 seconds or this can be visualised using the Decotest see 6 1 2 The unit is ready to start recording as soon as this signal stops RT User Manual 6 GB 14 May 2004 page 42 R TEST EVOLUTION Patient instruction Patient instruction The success of a procedure depends partly on the patient s co operation and understanding of its aims It 1s important therefore to give him the necessary instruction when the R Test is connected The following paragraphs summarise the most important points that the patient should be aware of at the beginning of the procedure We suggest that you first of all try out the operations on yourself so that you are familiar with them before explaining them to a patient RT User Manual 6 GB 14 May
58. they have not been removed RT User Manual 6 GB 14 May 2004 page 62 R TEST EVOLUTION Modem transmission 10 3 3 3 Disconnecting the R Test cable This operation must be carried out very carefully so as not to damage the unit nor the cable Training beforehand is essential To disconnect the cable from the unit the connector must first be unlocked do not pull using brute force the unit could be damaged D Press the two faces of the connector marked PRESS and 2 pull straight until clear as indicated in the picture above 10 3 4 Connecting the R Test to the modem cable The connector must fit into the R Test according to the symbol shown on the interior of the connector R Test and connector connected correctly RT User Manual 6 GB 14 May 2004 page 63 R TEST EVOLUTION Modem transmission 10 3 5 Transfer of recordings Once the connections for transfer are finished the receiver may have asked the remote user to notify him by telephone the remote user has only to press the M button black green on the R Test and the data transmission will go ahead automatically as follows the R Test gives a one second beep the modem initialises communication making various noises indicator lights may flash during several seconds then a telephone call noise is audible the transfer begins during which the modem gives a weak crackling noise the transfer can last anything from fifteen seconds t
59. tion of events When the R Test is programmed the total duration of its memory is divided up between the different types of pathologies The number of events of each type which can be memorised by the R Test depends on the size of the memory allocated to that type of event and the duration of the recording period chosen for each episode pre event post event In addition to this each time an event corresponding to one of the pre defined pathologies is identified the event counter for this type of pathology in the hour interval is incremented by l in the corresponding hour segment and the severity of the event is measured for pauses according to their duration for premature complexes according to their number and for bradycardias and runs according to their rate The R Test only stores the most severe events detected in its memory When the memory allocated to a pathology is saturated the R Test will only memorise a new event of the same type if it is more pronounced than the least severe event already memorised The new event will then replace the previous least severe event in the memory RT User Manual 6 GB 14 May 2004 page 22 R TEST EVOLUTION Operation This rule does not apply to multiple events which once memorised cannot be replaced It should also be noted that manually recorded events cannot be replaced when the memory allocated to them is saturated once this memory is full the manual recordin
60. ust make sure that it has been correctly set up modems usually have an on off switch which must be pressed These vary from one modem to another It is advisable to switch the modem off when not in use 10 3 3 Removing the R Test 10 3 3 1 End of recording If the R Test monitoring is not to continue after data transfer removal of the unit is not difficult The patient skin can then be dried or cleaned with soap and a clean cloth or following any instructions given by the physician 10 3 3 2 Temporary interruption of recording It is possible then either to proceed as above and after the transfer replace the electrodes with new ones or let the electrodes in place on the skin disconnect the patient cable neck cable or V5 cable from its electrode then disconnect the R Test from the sternum electrode then unplug the cable from the R Test with the V5 cable the suspension cable will not be disconnected form the R Test 10 3 3 2 1 Disconnecting the electrodes Cable electrode with a finger on each side of the press stud press firmly on the neck cable electrode and with the other hand lift up one side of the connector to remove it from the press stud of the electrode R Test electrode place a finger on each side of the press stud of the sternum electrode and lift up one side of the unit until it clicks out of the electrode This way the R Test and the cable can be reconnected to the same electrodes as

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