Related Manuals for Novacor R.TEST Evolution 4
Summary of Contents for Novacor R.TEST Evolution 4
- Page 1 R.TEST Evolution 4 User Manual NOVACOR 4 Passage Saint-Antoine 92500 Rueil-Malmaison FRANCE R.TEST Evolution 4 Manual NOVACOR - All rights reserved User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 1...
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Page 3: Table Of Contents
Multiple Events ..........................23 ......................23 ETTING OF THE EVENTS IN MEMORY ..........................24 EFAULT ROGRAM CONNECTING THE PATIENT ........................25 ..........................26 RDER OF CONNECTION ............................26 HOICE OF LEAD User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 3... - Page 4 ..........................35 ANDLING AND USE ............................... 35 LEANING ..........................36 FTER SALES ERVICE ........................36 TORAGE AND DISPATCHING ........................36 REVENTIVE AINTENANCE SPECIFICATIONS ............................. 37 ACCESSORIES AND CONSUMABLES ......................39 User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 4...
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Page 5: Introduction
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 to a computer for interpretation via a USB cable. - Page 6 If this is necessary, this unit and other devices should be observed for normal operation. Warning: The use of accessories other than those specified or sold by NOVACOR as replacement parts may result in increased emission or decreased immunity of the medical device and may cause improper operation.
- Page 7 Magnetic field at 30 A/m 30 A/m Home health care assigned environment and an industrial environment of a frequency professional health care (IEC61000-4-8) facility. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 7...
- Page 8 80 % MA at 1 80 % MA at 1 (IEC61000-4-2) 10 V/m 10 V/m 80 MHz at 2.7 80 MHz at 2.7 80 % MA at 1 80 % MA at 1 User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 8...
- Page 9 (specified above), it is necessary to test the product performance to verify that it conforms to the specifications. If User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 9...
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Page 10: Symbols
R.TEST 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 User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 10... - Page 11 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. User Manual - R.Test Evolution 4 EN V2019-12/06/2019...
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Page 12: Guarantees
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. -
Page 13: Description Of The Hardware
3 Description of the hardware R.TEST Evolution 4 is a recorder / analyser of ECG events ➢ ambulatory, ➢ automatic or manual, ➢ single channel, ➢ long term, Intended for asymptomatic and/or symptomatic patients. User Manual - R.Test Evolution 4 EN V2019-12/06/2019... -
Page 14: The Recorder R.test Evolution 4
A second press, starts the QRS beeps Indication of the memory state: - If red LED: memory full for one of the programmed events - If green led: no memory category is filled User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 14... -
Page 15: R.test-Pc Usb Cable
The use of accessories, sensors and cables other than those specified can induce an increase in the levels of electromagnetic emission or a reduction in the levels of immunity of the equipment. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 15... -
Page 17: Operation
- 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). User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 17... -
Page 18: Recording Modes
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 store the ECG corresponding to the pre-event recording time defined for this type of event and will continue to memorise the ECG until the end of the post-event recording time defined for this type of event. -
Page 19: Automatic Signal Analysis
32 days. Duration of From 2 to From 4 to From 8 to From 16 to < 48h examination 4 days 8 days 16 days 32 days Sampling of the HR User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 19... -
Page 20: Detection Of Rhythm Disorders
4.5.3 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) A QRS 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). - Page 21 AF. The algorithm used analyses the width of the distribution of R-R intervals as well as the temporal stability of alternations between regular and irregular states. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 21...
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Page 22: Consecutive Events
Contrary to the operation of R.Tests from 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. -
Page 23: Multiple Events
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. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 23... -
Page 24: Default Program
RR > 175% RR8N Tachycardia 00:15 00:30 Threshold > 140 bpm Bradycardia 00:15 00:30 Threshold < 50 bpm ST shifts 00:15 00:15 Offset ≥ 2 mm 00:45 00:45 Manual Markers 00:40 00:20 User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 24... -
Page 25: Connecting The Patient
ECG electrodes, with the CM5 lead, although another lead (such as the “Neck-Sternum”) can be chosen. The patient is connected, as described below, using ECG electrodes in most cases. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 25... -
Page 26: Order Of Connection
The replacement of the used batteries should be carried out just before the initialisation of the R.Test in order for it to function for the longest possible time. The use of special NOVACOR batteries allows the operation of the R.Test for up to 16 days in automatic mode with all options activated. -
Page 27: Programming Of The Recorder
If the batteries are low, the LED illuminates in red for 5 seconds 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. -
Page 28: Connecting The Patient Cable To The R.test
Placing the electrodes 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. - Page 29 (popper through a hole). Then connect the neck electrode, followed by the sternal electrode to the R.Test by simply applying light pressure. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 29...
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Page 30: Configuration In Cm5: Pre-Gelled Electrodes
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 neck, then click the R.Test onto the sternal electrode and the distant connector to the electrode in the V5 position. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 30... -
Page 31: Start Up And Hook-Up Test
- 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. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 31... -
Page 32: To Unplug The Cable From R.test
Completely engage the R.Test on the connector, in accordance with the symbol shown on the interior of the connector, until the two red positioning triangles are exactly face-to-face: Correctly connected R.Test and connector User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 32... -
Page 33: Disconnection Of The Cable
Change the batteries as indicated in §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 procedure continues automatically. User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 33... -
Page 35: Maintenance
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. -
Page 36: After-Sales Service
No repair can take place without a signed order from the customer. Storage and dispatching Take care to remove the R.Test Evolution 4 batteries if the 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;... -
Page 37: Specifications
• pre-event 0 + post-event 30s to 60min manual mode only Total Duration of recording • • ECG events 60 min • • Heart rate and histograms trend 32 days User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 37... - Page 38 Precision of the ECG in voltage: ± 6 µV Storage 100 Hz PC connection USB2.0 Full compatible Speed Lifetime of the device (estimate) 5 years 5 years Lifetime of the accessories (estimate) User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 38...
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Page 39: Accessories And Consumables
R.Test - PC USB Cable ACC-0159-00 1 part Software RTSoft PC LOG-0700-05 DVD Applications User Manual R.TEST Evolution 4 (this handbook) CDI-0201-00 CD Manuals First placed on the market in 2011 User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 39... - Page 40 User Manual - R.Test Evolution 4 EN V2019-12/06/2019 Page 40...