R.TEST Evolution 4 User Manual
Contents
1. NovacoR_ NN de ee SE j Correctly connected R Test and connector 5 9 2 Disconnection of the cable To disconnect R Test from the cable After having turned over the R Test connector it is necessary to R Test Evolution 4 User Manual 6UK 23 07 2012 Page 34 press firmly on the serrated part of the connector using the thumb and forefinger before e releasing the R Test from the connector by moving them apart 5 10 Resuming monitoring 5 10 1 Without changing batteries It is possible after reading the R Test data to continue the recording for the same patient Simply reconnect the R Test and its cable to the patient electrodes the procedure continues automatically 5 10 2 Changing batteries Carry Out the change of the batteries as indicated in the 5 3 Inserting new batteries After the start up the led must flicker green once every five seconds Then simply reconnect the R Test and its cable to the patient electrodes the procedures continues automatically R Test Evolution 4 User Manual 6UK 23 07 2012 Page 35 6 Maintenance 6 1 Handling and use The installation of the apparatus to a patient must be carried out by a qualified person Always press the centre of the recorder s keys never use a blunt or pointed object or your finger nail A The R Test Evolution 4 can be fitted to children of less than ten kilograms If you believe there is any risk of strangulation with2. NovacoR R TEST Evolution 4 User Manual R TEST Evolution 4 User Manual NOVACOR SAS 4 passage Saint Antoine 92508 Rueil Malmaison Cedex France R TEST Evolution 4 Manual NOVACOR SAS All rights reserved R Test Evolution 4 User Manual 6UK 23 07 2012 Page 2 R Test4 Evolution CONTENTS stone de nn an one dec nana nee na tn ect ema Ne ee Reese sc none eee nue 5 INTRODUCTION as 7 DESCRIPTION OF THE HARDWARE 2 an 15 OPERATION see eier RE PRE 19 CONNECTING THE PATIENT 8005 27 MAINTENANCE ueber 37 SPECIFICATIONS sn es E rouen ee 39 ACCESSORIES AND CONSUMABLES suis 41 1 Contents 1 CONTENT eee sense ee Rae Ge een eee ace 5 2 INTRODUCTION nenn ee 7 2 1 DESCRIPTION OF PRE DEVICE Se ee da a eee nee erster 7 2 2 7 2 3 SAP ET INFORMATION ea 7 2 4 ee ea a E a D co ae ee ne 11 2 5 GUARANTEE a ee se a de 14 2 5 1 Specific Guarantees of the DEVICE unsre rennen 14 2 5 2 Specific Guarantees Of the accessories 14 253 A T E ee ee EE EOE 14 PO AEDO een een 14 251 Er NMO ON ETENEE ee 14 CO 5 g E a AEEA EE A EAE EEEE te en ee 14 3 DESCRIPTION OF THE HARDWARE u een 15 3 1 THE RECORDER IR DES EVOLUTION A nee ea 16 3 2 ABLE ee E ee 17 3 3 ACCESSORIES A A en ern 17 4 OPERATION eat 19 4 1 COLLECTION OFEN Aa ee 19 4 2 RECORDING MODE ee
3. p d 3 P 3 For transmitters for which the maximum transmission power assigned is not displayed above the recommended separation distance d in meters m can be estimated by using the equation applicable to the frequency of the transmitter where P is the maximum power of output of the transmitter in watts W according to the manufacturer of that transmitter Note 1 At 80 MHz and at 800 MHz The separation distance for the highest frequency range applies Note 2 These guides may not be applied in every situation The electromagnetic spread is affected by the absorption and by the reflexion of structures objects and people Precautions for use must be taken with respect to the phenomena of electromagnetic compatibility CEM R Test Evolution 4 must be installed and commissioned above and in accordance with recommendations CEM Abnormal operations can be caused by the proximity of communication equipment such as RF portables or mobiles R Test Evolution 4 is not protected from the effects of the discharges of an external defibrillator The minimal amplitude of the physiological patient signals is 0 5 mV The use of the equipment close to this minimal level can generate incorrect results The equipment or system is under the responsibility of qualified staff This equipment or system can be the source of radio interferences or be the source of abnormal operations of another apparatus located in the immediate vicinity Some car
4. 5 6 2 Neck Sternum configuration with solid gel electrodes ccccseeccccseseecceeececeesececeesesesesecsesseseeenses 30 5 6 3 Configuration in CM5 pre gelled 32 5 7 START AND HOOK UP TEST 2 en as aeg 32 5 7 1 Startup in continuous 32 22 DISCONNECLDN TEIL ee a ai nd ae ET 33 5 8 REMOVING THE Re TEST nun a eier 33 58 1 nao DON LONG een 33 5 8 2 Temporary Interruption Of the monitoring ss 33 583 To Unplug the cable HOMER rennen ee ehren ersehen energie 33 5 9 CONNECHONTORL ON DT Eee E 34 591 Comec hote R ete a 34 592 DISCO een ana ee de ee a en ee 34 5 10 RESUMINGIMONITORIN Siesta ee tn de 35 5 10 1 Without changing batteries 35 5 10 2 changing DALOTIES 35 6 MAINTENANCE aa en sa O EHRT RER EEG 37 6 1 SAINS ANSE ee ee a se en Bene 37 6 2 CHEANING ee re ee EN a te ta 37 6 3 AFTER SALES SERVICE ee ee een 37 6 4 STORAGE ANID DIEPAT HIN G san nee ee ern 38 6 5 PREVENFIVE MANTENAN E ne ea 38 7 SPECIFICATION ea 39 8 ACCESSORIES AND CONSUMABLES nun ea 41 R Test Evolution 4 User Manual 6UK 23 07 2012 Page 6 2 Introduction 2
5. 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 a minimum charge for administrative and testing costs An estimate will be sent by mail or fax upon receipt of the unit and completion of the diagnostic tests No repair can take place without a signed order from the customer 6 4 Storage and dispatching Take care to remove the R Test Evolution 4 batteries ifthe device will be stored for more than a few days During shipping the R Test Evolution 4 is protected by its packaging This should be kept in case it is needed at a later date it also contains a Complaint Report form you will be able to use in the event of incident during the use of the device When throwing out the batteries use proper containers following any applicable local laws You must respect the current regulations concerning the disposal of the unit 6 5 Preventive Maintenance A preventive check up of the recorder is recommended every two years This check up will reduce the number of potential break downs and prolong its useful life The unit will be checked for its correct functioning in particular ECG amplifiers and safeguard battery The check up must be carried out in our workshop or by an approved distributor The invoicing covers the tests only the quote for any necessary repair will be sent by mail or by fax The repair can only be carri
6. 1 Description of the device The R Test Evolution 4 is a miniature automatic ECG arrhythmia detection device it is quick and easy to fit to the patient It is designed to detect and store the most important pathologic events symptomatic or asymptomatic as well as the patient s continuous heart rate and is capable of up to 32 days of ambulatory monitoring The system consists of a unit weighing approximately 40 grams that can be worn by the patient unobtrusively and without any discomfort The R Test Evolution 4 is connected to the patient by a system of electrodes and a neck cable Events stored by the R Test Evolution 4 are then transferred for interpretation via a USB cable connected to a computer The use of a computer will allow the programming of the conditions and criteria for each recording made by the R Test Evolution 4 in addition to select organize and store the results of the examinations then to print them in the form of a customised report according to your needs 2 2 The manual This manual describes the physical operation instructions characteristics technical specifications and the particular recommendations of use of the R Test Evolution 4 and its accessories Although the greatest care was taken in its drafting in order to make it as complete as possible NOVACOR does not accept any responsibility for any errors omissions or inaccuracies which it may contain The functionalities of the device and the access
7. ILS Connecting the ECG cable to the patient When connecting it Always connect the cable to the recorder first then to the electrodes on the patient R Test Evolution 4 User Manual 6UK 23 07 2012 Page 12 When removing the unit Always disconnect the ECG cable from the electrodes on the patient before unplugging the cable from the recorder NOVACOR will provide electrical circuit diagrams and information about the nature of the materials for customers if required R Test Evolution 4 User Manual 6UK 23 07 2012 Page 13 2 5 Guarantees NOVACOR undertakes to deliver merchandise conforming to the technical specifications mentioned and to replace any merchandise recognised as being defective during the period of guarantee 2 5 1 Specific Guarantees of the device NOVACOR guarantees the unit for the period of one year from the date of delivery against any defect resulting in the unit functioning abnormally 2 5 2 Specific Guarantees of the accessories The parts or components not considered an integral part of the device and in particular the accessories and cables do not benefit from any particular guarantee 2 5 3 Limits of guarantee The guarantee does not apply 1 if the device is repaired or opened outside of our workshops 2 if the device is damaged following negligence accident or use that does not conform with the procedures described in the instruction manual If necessary please contact your local distribu
8. ORS Couplets and Triplets 1 2 or 3 consecutive premature QRS Runs 4 or more consecutive premature QRS This identification enables the R Test to distinguish 8 subcategories of rapid events lsolated Supraventricular Ectopic e Supraventricular Couplets e Supraventricular Triplets e Supraventricular Runs lsolated Ventricular Ectopic e Ventricular Couplets e Ventricular Triplets e Ventricular Runs In the case of the isolated events couplets and triplets of the same type the reserved memory capacity is common If the memory is full a new event will replace another according to the following criteria of gravity a triplet is more serious than a couplet which itself is more serious than an isolated premature QRS Standard program RR lt RR8N 25 RR8N 4 5 3 2 Absolute Pauses Characterised by an R R interval exceeding a certain duration whatever the morphology of the QRS and irrespective of the presence of a premature QRS Standard program RR gt 2 0 seconds R Test Evolution 4 User Manual 6UK 23 07 2012 Page 22 4 5 3 3 Relative Pauses Characterised by an R R interval exceeding a given percentage of the mean reference R R interval providing that it does not follow a premature ORS complex and that its duration is shorter than the absolute pause threshold Standard program RR gt 175 RR8N 4 5 34 Bradycardia Characterised by the decrease of the reference heart rate below a threshold with a minimum
9. R Test are sufficiently far apart from one another for their recordings to be separate These two events are therefore two single events 4 6 2 Superimposed Events enregistrement 2 Superimposed Events If the interval separating two events is lower than the post event duration of the first pre event of the second and the second event actually occurs after the post event of the first has finished they will each be recorded normally each one in its own category Contrary to the operation of R Tests of preceding generations the second recording will not be shifted in time the concept of chain events no longer exists with R Test Evolution 4 Each event respects its parameter settings of pre event and post event R Test Evolution 4 User Manual 6UK 23 07 2012 Page 24 4 6 3 Multiple Events Evt2 anteriorite 1 post riorit 1 enregistrement 1 Ev nements multiples Multiple Events When two consecutive events are such that the second occurs in the post event of the first the second will not be recorded separately However if it is either an absolute pause or a run i e at least 4 consecutive premature 5 the recording of this double event will be identified as a multiple event 47 Setting of the events in memory 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 memoris
10. een ee ee ee ee 20 Manua RCC OMIA ee een na 20 4 2 2 Automatic Recording with the option of patient activated recordings 20 4 3 OPERATION IN MANUAL RECORDING MODE uasenssenesensnnennnnnnnnnnennnsnnnnnnnnnnsnnnnnnsnunsnnnsnnsnunsnnnsnnsnunsnnssnnsnnnsnnsnnnenen 20 4 4 OPERATION IN AUTOMATIC RECORDING MODE zu ee aa 20 4 5 AUTOMATIC da nn er ee 21 751 DOUTE ER 21 4 5 2 21 45 3 Detection of rhythm lt 22 4 6 ROSE CUTIE E een 24 AoT SIMPE EVEN ee ee er er 24 462 SUPT OSC EVENTS a 24 263 NA EI DIVERS 25 4 7 SETTING OF THE EVENTS IN MEMORY ee ose 25 4 8 DEFAULT PROGRAM anne a ee ee ee 26 5 CONNECTING THE PATIENT en nie 27 Dall ORDER OF CONNECTION ee en 28 5 2 CEO re De ea ee mse ne 28 521 NEC Con gurao 28 5 22 LONG ANDRES a a te 28 R Test Evolution 4 User Manual 6UK 23 07 2012 Page 5 5 3 INSERTING NEW BATTERIES nt ee 28 5 4 PROGRAMMING OF THE RECORDER as ea ne ennemies 29 5 5 CONNECTING THE PATIENT CABLE TO THE IR TEST une 29 5 6 PLACING THE ELECTRODES AND CONNECTING THE RS EST nenne en 30 IOL ON re ee de ore Tener ete ee a ee eer ee 30
11. emits a signal modulated by the ECG The modulation of the signal during its 20 seconds duration makes it possible to immediately detect with the ear possible anomalies in the detection of the ECG R Test Evolution 4 User Manual 6UK 23 07 2012 Page 32 After these 20 seconds the recording starts and R Test emits beep synchronised with each detected QRS In the absence of visualisation of the signal a perfect synchronization of the beeps with the pulse of the patient during at least 30 seconds constitutes the best guarantee that the selected configuration is sufficient in amplitude gt 1 mV In automatic mode this check is imperative if you want to ensure a reliable detection If it proves to be negative it is advisable to check the quality of the connections and the positioning of the electrodes Once you are happy press again on the central key to stop the beeps and to allow manual recordings to be made Throughout the entire recording the Led emits a green flash every 5 seconds to indicate the status is recording in progress 5 7 2 Disconnection Test If the disconnection alarm has been programmed recommended disconnect the unit or the cable from an 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 ou
12. the spiral cord of the 5 cable you can decide not to place it around the neck or alternatively make use of the V5 cable Operation in moist environment The R TEST Evolution 4 is water resistant to IPx4 and is protected from splashing water projections However the device does not have any specific protection against moisture when the ECG cable is not connected Do not use the R TEST 4 if any part including the cables appears broken or damaged Do not make any additions or modifications to the equipment other than fitting a replacement Novacor branded cable but return it to your dealer for repair 6 2 Cleaning Before carrying out cleaning the cable must be connected and the batteries removed Regularly clean and disinfect the R Test Evolution 4 and its accessories We recommend gently wiping with surgical spirit 70 never use very strong disinfectants such as nail polish remover or acetone A Never leave the device in touch with liquid or a wet tissue If you want to use another cleaning product make a preliminary test to ensure there is no degradation to the coating In particular it is recommended to thoroughly clean the ECG cables between patients 6 3 After sales Service 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 or to provide compensation of any sort R Test Evolution 4 User Manual 6UK 23 07 2012 Page 37
13. e of instalment could be necessary The equipment should not be used adjacent to or placed upon other equipment If this use is necessary a check for good performance of the equipment in this configuration must be made 2 4 Symbols R Test Evolution 4 User Manual 6UK 23 07 2012 Page 11 This sign on an apparatus indicates to the user that additional information available in the accompanying documents must be consulted R Test Evolution 4 works exclusively with an internal power source and complies with standards of protection for units in class BF Fitted with its ECG cable R Test Evolution 4 is classified IPx4 protected against pxa Water projections R TEST Evolution 4 is not an apparatus of category AP nor APG R TEST Evolution 4 is planned for a continuous service _R TEST Evolution 4 is in conformity with the Electromagnetic standard of Compatibility EN 60 601 1 2 However if it is used in a very specific way there can be some problems with interference CE Mark according to European Directive 93 42 for medical devices The device does not possess any specific protection against humidity as a consequence it is recommended to store it in a dry place Risk associated with the ESDs The product must be eliminated in a structure of suitable recovery and recycling ZN Store away from light m a Storage Temperature Limits Humidity Storage Limits Pressure Storage Limits
14. ed 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 is incremented by 1 in the corresponding hour segment and the severity ofthe event is measured for pauses according to their duration for premature complexes according to their number and for Bradycardia Tachycardia and runs according to their rate The R Test stores only the most serious detected events When the memory allocated for a given type of pathology is saturated the R Test does not memorise a new event of the same type unless it more serious than the least serious event it has already preserved In the case that a new event is more serious in order to free enough memory for this new event the least serious event is erased This rule does not apply to the multiple events which once memorised cannot be overridden R Test Evolution 4 User Manual 6UK 23 07 2012 Page 25 In addition it should be noted that the manually recorded events cannot be replaced when the allocated portion of memory is saturated by them as a result the manual event button becomes inoperative until the R Test is reprogrammed During the whole time it is connected to the patient the R Test also memorises
15. ed out upon reception of a customer order R Test Evolution 4 User Manual 6UK 23 07 2012 Page 38 7 Specifications Weight with batteries Index IP with ECG cable in place Temperature 20 45 C Conditions of storage transport Moisture 10 to 95 non condensing Pressure 500hPA to 1060hPA Temperature 10 C to 45 C Operating Conditions Moisture 10 to 99 Pressure 700hPA to 1060hPA 675 Zinc Air Batteries Type IEC PR44 ANSI NEDA 700320 Automatic Recorder ECG Arrhythmia detection Type of recorder and Heart Rate trend Manual Recorder of ECG episodes Supraventricular and Ventricular ORS Isolated couplets triplets and runs Dec Absolute and relative Pauses Bradycardia Tachycardia ST shifts Atrial Fibrillation Manual Markers automatic mode Maximum Number of events Duration of the events Programmable from 105 to 60 min with pre event minimum 55 maximum 5 min e automatic mode post event minimum 5s maximum 59 min 55s looping memory e manual mode only pre event 0 post event 30s to 60min R Test Evolution 4 User Manual 6UK 23 07 2012 Page 39 Total Duration of recording e ECG events Heart rate and histograms trend Maximum Duration of an examination e automatic mode e manual mode only Electrical Supply Number of channels Data Storage Memory Lifetime Sampling and analysis Vertical Resolution Precision of the ECG in duration Precis
16. ents who perspire heavily or who will be connected to the R Test for more than 24 hours 5 6 2 2 Connecting the cervical electrode Cervical Electrode Electrode plus adhesive patch Put the R Test and cable around the patients neck like a necklace without attaching the unit to the sternum and let it 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 a hole Then connect the neck electrode followed by the sternal electrode to the R Test by simply applying light pressure R Test Evolution 4 User Manual 6UK 23 07 2012 Page 31 5 6 3 Configuration in 5 pre gelled electrodes Configuration in CM5 5 6 3 1 Placing the electrodes 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 Plug the 5 cable into the R Test as indicated before for the neck sternum cable put the spiral support part around the patients neck then click the R Test onto the sternal electrode and the distant connector to the electrode in the V5 position 5 7 Start up and hook up test 5 7 1 Startup in continuous mode Press on the central key on the device to start The R Test
17. es and connecting the R Test 5 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 a few days after the electrodes are removed If the patient s skin is particularly sensitive wait until the rash has completely disappeared before placing electrodes on him again and take any other precautions that you consider necessary The installation of the electrodes for the R Test requires careful preparation of the patients skin it is recommended to shave the site of the electrodes where necessary and if clean the area with a suitable wipe and then thoroughly dry 5 6 2 Neck Sternum configuration with solid gel electrodes Neck Sternum configuration R Test Evolution 4 User Manual 6UK 23 07 2012 Page 30 5 6 2 1 Connecting the sternal electrode Sternal electrode Electrode with reinforcement 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 is particularly large i Adhesive patches must be used to make sure that the solid gel electrodes adhere properly especially for pati
18. esponding to the pre event recording time defined for this type of event and will R Test Evolution 4 User Manual 6UK 23 07 2012 Page 20 continue to memorise the ECG until the end of the post event recording time defined for this type of event If during post event other events are detected they will be simply marked on the ECG but the R Test will not start a new recording see also 5 4 6 3 Multiple Events ant riorit 1 posteriorite 1 Enregistrement 1 45 Automatic Signal Analysis The analysis of the ECG takes place in real time in the R Test as the ECG signal is stored in the buffer the microchip of R Test using a specific software algorithm carries out the following operations automatically identification of the QRS and possible elimination of artefacts e determination of the morphology of the QRS e calculation of R R intervals and the basal heart rate e continuous storage of the heart rate e recognition and hourly counting of arrhythmic events memorisation of selected episodes with date and time QRS and events characteristics 4 5 1 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 preceding few R R intervals recognised by the R Test as being normal Excluded from this average are R R intervals considered normal these include periods of artefact pauses interva
19. hoose between the neck sternum and the 5 lead configurations there is a specially designed cable for each The neck sternum configuration allows the collection of the ECG signal characterised by morphology and an amplitude of QRS similar to V2 e significantly different right and left ventricular activations e generally optimal P waves amplitude The CM5 configuration allows collection of the ECG signal characterised by amorphology and an amplitude of QRS similar to V5 anamplitude often greater than the neck sternum configuration The 5 cable may provide a better recording of ST changes and give more flexibility when the anatomy of the patient s sternum makes it impossible to connect the R Test normally 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 events whether they be cardiac or not R Test Evolution 4 User Manual 6UK 23 07 2012 Page 19 42 Recording modes The clinician can decide to use one of the two options below 4 2 1 Manual Recording The ECG is recorded by the R Test for one predetermined length of time without analysis or processing when the patient presses on the manual e
20. hour by hour the total number of events detected for each pathology whether they are memorised or not This enables tables and event histograms by pathology to be created for the whole monitoring period 48 Default Program Pre event Post event Standard event Criteria of detection mm ss mm ss __ 1403 0015 005 21 60 ____ PSVT 00 15 00 15 10 300 Threshold lt RR8N 25 RR8N Threshold lt RR8N 259 RR gt 175 Tachycardia 0015 0015 8 240 Threshold gt 140 bpm _ Bradycardia 0015 0015 8 240 Threshold lt 40bpm _ STshifts 0025 005 6 240 Offsetz2mm 0015 000 8 8D Manual Markers 0020 0010 8 20 R Test Evolution 4 User Manual 6UK 23 07 2012 Page 26 5 Connecting the patient Hg z ei gs zzzz P mm zz 9 are The R Test Evolution is usually connected to the patient using ECG electrodes with the 5 lead although another lead such as the Neck Sternum 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 Neck Sternum lead and metal electrodes can be used The patient is connected as described below for most cases ECG e
21. ion of the ECG in voltage Storage PC connection R Test Evolution 4 User Manual 6UK 23 07 2012 e 32 days 2 months Page 40 8 Accessories and consumables The following accessories and consumables are available from your supplier Accessory amp Consumables Reference Conditioning Special Batteries Box of 60 batteries Pre gelled Ag AgCl Electrodes Box of 50 electrodes Neck Cable configuration neck sternum 1 part CM5 Cable standard 40 cm 1 part CM5 Cable long 60 cm 1 part V5 cable standard 30cm 1 part V5 cable long 60cm 1 part Battery Cover RT4 1 part R Test PC USB Cable 1 part Software RTSoft PC CD Applications User Manual R TEST Evolution 4 this handbook as CD Applications R Test Evolution 4 User Manual 6UK 23 07 2012 Page 41 0459 R Test Evolution 4 User Manual 6UK 23 07 2012 Page 42
22. ion of the R Test for up to 16 days in automatic mode with all options activated The R Test should be used only with Zinc Air 1 4V batteries PR44 respecting the A polarity of insertion Do not forget to remove the cover placed on the bottom of the batteries before use R Test Evolution 4 User Manual 6UK 23 07 2012 Page 28 Insert the new batteries respecting the polarity indicated the side bottom of the batteries directed upwards The R Test then begins a cycle of battery checks for a few seconds ending with a double tone If the batteries are new the LED illuminates green for 5 seconds If the batteries are not new the LED illuminates orange for 5 seconds If the batteries are low the LED illuminates in red for 5 seconds 5 4 Programming of the recorder Connect the R TEST Evolution 4 to the PC via the USB cable then Program Read via the software to choose the program to be used as well as to input patient information Note it is not necessary to have inserted batteries to read or program and R TEST Evolution 4 with the USB cable 5 5 Connecting the Patient Cable to the R Test R Test cable R Test Evolution 4 User Manual 6UK 23 07 2012 Page 29 Make sure that the connector is lined up with the R Test so that the logos on the connector and the front plate of the R Test are visible at the same time Guide the connector into the unit until it is locked into position 5 6 Placing the electrod
23. ith accuracy In order to evaluate the electromagnetic environment due to set transmitters an electromagnetic investigation on location must be considered If the field intensity measured at the location where the R TEST Evolution including the cables is used exceeds the level of RF conformity applicable above the R TEST Evolution must be observed including the cables to check if it is running normally If abnormal performances are observed extra measures may be necessary in order to reorient or reposition the R TEST Evolution including the cables on the range of frequencies 150kHz to 80MHz field intensities must be lower than V m Separation distances recommended between portable RF devices and or mobile telephones and R TEST Evolution 4 R TEST Evolution 4 is meant to be used in an electromagnetic environment in which RF disturbances are checked The R TEST Evolution user can help prevent electromagnetic disturbances by maintaining a minimum distance between the portable device and the RF communication mobile transmitters and the R TEST Evolution as it is recommended below according to the maximum transmission power of the communication device Outdistance separation according to the frequency of the transmitter m R Test Evolution 4 User Manual 6UK 23 07 2012 Page 10 emission assigned of From 150 Khz with 80 From 80 MHZ with 800 From 800 MHZ with 2 5 the transmitter W MHZ MHZ GHZ 3 3 5 5 7 d yp d
24. lectrodes R Test Evolution 4 User Manual 6UK 23 07 2012 Page 27 5 1 Order ofconnection Choice of lead Inserting new batteries Initialising the unit Connecting the patient cable to the R Test Placing the electrodes on the patient and connecting the R Test Start up and start up test 5 2 Choice of lead 5 2 1 Neck Sternum Configuration This configuration which gives an ECG signal of very good quality in particular with clear P waves requires the use of the neck cable ref ACC 0105 00 It must also be chosen to carry out specific manual only recordings with metal electrodes on symptomatic patients 5 2 2 Configuration CM5 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 CM5 lead instead The 5 lead may also be used for analysis of ST segment changes or if there are problems with the patient s sternum 5 is the standard lead supplied with the R Test Evolution 4 5 3 Inserting new batteries The replacement of the used batteries should be carried out just before the initialisation of the R Test in order that it can function for the longest possible time The use of special NOVACOR batteries allows the operat
25. ls preceding and following premature QRS in order to also eliminate compensatory pauses By default this calculation is carried out on the last 8 normal R R intervals collected noted RR8N 4 5 2 Storage 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 minimum rate mean rate and maximum rate The duration of this interval is chosen according to the length of time that the patient is connected to the unit The R Test therefore also provides the physician with continuous monitoring of the minimum mean and maximum heart rates for a period of up to 32 days R Test Evolution 4 User Manual 6UK 23 07 2012 Page 21 Duration of lt 48h From 2 4 From 40 8 From8to From 16 to examination days days 16 days 32 days Sampling of the HR 45 3 Detection of rhythm disorders Arrhythmias detected by the R Test are classified in several categories Some automatic functions of the R Test Evolution 4 may be available only as additional options 4 5 3 1 Fast Rhythm disorders premature QRS and salvos AORS is considered as premature if the R R interval preceding it is lower by a given percentage standard program 25 compared to the base period RR8N The R Test characterises premature ORS according to The morphology Normal or Narrow QRS as Supraventricular Aberrant or Wide ORS as Ventricular Their organisation Isolated
26. munication Electromagnetic Emissions Conformity Group 1 Warning prone to the electromagnetic environment R TEST EVOLUTION 4 uses RF energy only for its internal functions Consequently its RF emissions are very weak and are not likely to cause interferences in a nearby electronic device R TEST EVOLUTION can be used in all institutions including domestic buildings Nonapplicable Nonapplicable Electromagnetic Immunity Conformity Conform Conform Warning regarding the electromagnetic environment If the ground is covered with synthetic materials it is appropriate that the relative humidity is at least 30 It is appropriate that the magnetic fields at the frequency of the electrical communication have the levels characteristic of a representative place located in a typical hospital environment R Test Evolution 4 User Manual 6UK 23 07 2012 Page 8 Electromagnetic Immunity Tests of Level of tests CIS Warning regarding the electromagnetic immunity 60601 environment 50 60 Hertz CIS 61000 4 8 Led RF 3 Veff 3 V It is appropriate that the portable RF devices and mobile communications devices are too not close to CIS 61000 4 6 from 150 Khz with every part of R TEST 4 including the cables It is 80 MHZ outside tapes ISM advisable to respect the distance from separation recommended computed starting from the equation applicable to the frequency of the t
27. of 8 consecutive RR intervals Standard program 8xRR lt 40 BPM 4 5 3 5 Sinus Tachycardia Characterised by the increase of the reference heart rate above a given threshold Standard program 8xRR gt 140 BPM 4 5 3 6 STSegment Analysis The ST segment is characterised by its shift compared to the base line it can be positive elevation or negative depression It is measured in millimetres mm the scale of the ordinates being of 1 mV cm 30 MSy 4 60 ms 4 Location of the measurement points An ST episode can be recorded by the R Test if during 32 QRS the shift is larger than the programmed threshold For the histograms the R Test computes the averages shift for each 30 period and retains the maximum and minimum shift values 4 5 3 7 Atrial Fibrillation Analysis Atrial fibrillation is often associated with a fast and irregular heart rate An analysis of the rhythm makes it possible to detect episodes of AF The algorithm used analyses R Test Evolution 4 User Manual 6UK 23 07 2012 Page 23 the width of the distribution of R R intervals as well as the temporal stability of alternations between regular and irregular states 46 Consecutive Events 4 6 1 Simple Events ant rorit 2 post 2 ant riorit 1 post riorit 1 Enregistrement 1 Enregistement2 Enregistrement2 2 Ev nements simples Simple Events In general two consecutive events detected by the
28. ories as well as the contents of the manual can be modified by NOVACOR without notice 2 3 Safety information Intended Users The R Test Evolution 4 is intended for use by a licensed physician or a person working under his supervision The patient is required to wear the device and should trigger recordings manually the physician should ensure that the mental and physical condition of the patient is compatible with an R Test procedure The physician should inform the patient of the nature ofthe test and any actions that are required e g removal of the recorder for shower manual activation of recordings etc R Test Evolution 4 User Manual 6UK 23 07 2012 Page 7 The R Test 4 should not be used on patients with potentially life threatening arrhythmias who require inpatient monitoring or on patients who the attending physician thinks should be hospitalised Recommendations and Manufacturer s declaration The R TEST Evolution 4 is meant to be used in an electromagnetic environment only as specified below The clinician should make sure the device is used in such an environment Tests of emissions Emissions RF CISPR 11 Emissions RF CISPR 11 Emission of harmonics CIS 61000 3 2 Emission of fluctuation of tension CIS 61000 3 3 Tests of Level of tests CIS immunity 60601 Electrostatic 6kV with the Discharge contact 8kV in the air Magnetic Fields at the frequency of the electrical com
29. ransmitter Recommended separation distance d 1 17 p d recommended separation distance inm p maximum output power of the transmitter in W Ex to see table Ci afterwards Interferences can occur near the marked devices of the following symbol R Test Evolution 4 User Manual 6UK 23 07 2012 Page 9 Electromagnetic Immunity Tests of Level of tests CIS Warning regarding the electromagnetic immunity 60601 environment Radiated RF 3 V m of 80MHz 3 V m Outdistance separation recommended with 2 5GHz CIS 61000 4 3 d 1 17 p of 80MHz with 800 Mhzs d 2 33 p of 800Mhz with 2 5Ghz d distance from separation recommended in m maximum power of output of the transmitter out of W Field intensity of RF transmitters should be set determined by an electromagnetic investigation on location and should be lower than the level of conformity in each frequency range Ex See the following table Note 1 With 80MHz and 800 MHZ the highest band frequency applies Note 2 These guides may not apply in all situations The electromagnetic propagation may be affected by the absorption and reflections of structures objects and people Field intensities of the transmitters that are set such as base stations for radiotelephones cellular wireless and land mobile radios amateur radio radio broadcasting AM and FM and TV broadcasting cannot be theoretically forecasted w
30. ser of ECG events gt ambulatory gt automatic or manual gt single channel gt longterm Intended for asymptomatic and or symptomatic patients Page 15 R Test Evolution 4 User Manual 6UK 23 07 2012 3 1 The recorder R TEST Evolution 4 4 hi Real time transmission Multifunction LED Indicator Initialisation Manual Event Recording Information ECG USB Connector R Test Evolution 4 User Manual 6UK 23 07 2012 Page 16 3 2 R Test PC USB Cable 3 3 Accessories ra 2 Pre gelled electrodes 3 Reinforcements of electrodes A Metal electrodes CM5Cable standard 40 cm or long 57 cm R Test Evolution 4 User Manual 6UK 23 07 2012 Page 17 an increase in the levels of emission a reduction in the levels of immunity of the N The use of accessories sensors and cables other than those specified can induce equipment R Test Evolution 4 User Manual 6UK 23 07 2012 Page 18 4 Operation 4 1 Collection of ECG signal The surface ECG signal is collected according to a bipolar configuration between two ECG electrodes especially adapted to the R Test The apparatus is integrated directly with one of the electrodes in contact with the patient s sternum The second electrode placed either behind the neck or on the patient s side is connected to the R Test by using the supplied accessory The physician is free to c
31. t The patient should be provided with an extra set of electrodes in case he needs them 5 8 Removing the R Test 5 8 1 End of monitoring If the R Test monitoring is not to continue after data transfer simply disconnect the recorder together with its cable from the electrodes The electrodes can then be removed and the patient s skin can then be cleaned and dried if required following any instructions given by the physician 5 8 2 Temporary Interruption of the monitoring You can choose to proceed as previously described and after the data transfer to replace the electrodes with new ones or to leave the electrodes in place disconnect the R Test from its sternal electrode and then unplug the cable from the R Test as described below 5 8 3 To Unplug the 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 R Test Evolution 4 User Manual 6UK 23 07 2012 Page 33 disconnect the cable from the unit the connector must first be unlocked do not pull using brute force the unit could be damaged Press firmly on the two faces of the connector marked PRESS and pull straight until clear as indicated in the picture above 5 9 Connection to computer 5 9 1 Connecting the R Test PC cable Completely engage the R Test on the connector in accordance with the symbol shown on the interior of the connector
32. tor or our after sales service directly We do not accept any return of goods without prior arrangement 2 5 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 repair of the unit within the limits of the guarantee 2 5 1 Users information All the customers duly recorded at NOVACOR or if necessary by its distributors will be kept informed as well as possible of various developments of R TEST Evolution 4 2 5 2 Copyrights Manual R TEST Evolution 4 2011 Novacor SAS All rights reserved R Test is a registered trademark of NOVACOR SAS Windows is a registered trademark of Microsoft Corporation R Test Evolution 4 User Manual 6UK 23 07 2012 Page 14 3 Description ofthe hardware R TEST Evolution 4 is a recorder analy
33. vent button on the device Each recording is obtained according to the pre and post event durations set in the current program configurable by the clinician via the software 4 2 2 Automatic Recording with the option of patient activated recordings The ECG signal is processed and analysed in real time and the most significant pathologies are stored into the memory of the device Each recording is obtained according to the criteria and to the pre and post event durations set in the current program configurable by the clinician via the software 4 3 Operation in manual recording mode This mode is intended for symptomatic patients for whom one wishes to carry out a recording of the crisis or symptom even if this symptom is not very frequent 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 4 4 Operation in automatic recording mode 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 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 5 minutes During the detection of an event R TEST Evolution 4 will record the ECG corr
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