Cardioline ar600 - User manual
Contents
1. fe to start the recording If the signal has not yet been initialized the LED A lights up momentarily he At the end of acquisition 10 seconds the LED Y blinks indicating that the signal has been completely stored in the memory It is now possible to disconnect the patient 22 he ES to interrupt printing stop If the signal is already in memory LED Y blinking it will still be possible to print a copy of the recording Automatic calculation of the ECG parameters M7 The program for automatic measurement of the ECG parameters allows you to obtain a report of the principal measurements calculated at the end of each automatic recording he Start automatic at the end of the recording he Stop automatic at the end of printing the report The principal items of information in the report are The average ECG complex for the ECG lead with the greatest ST level deviation The following measurements are indicated by markers on the average ECG complex onset and offset of the P wave QRS and end of the T wave calculated measurement of the following parameters QRS duration PQ interval QTc interval corrected ST level deviation interval RR and heart rate If any of these parameters are outside of normal limits they are flagged with an asterisk representation of ECG rhythm Caution if it is not possible to calculate the measurements a message is reproduced on paper Measurements or analysis impossible d2. D On Off G selection of operating mode alll Selection of recording sensitivity ox Ns mains and muscle interference filter selection of paper speed a start selected operating mode interrupt current operation stop 10 Associated LEDs LED on device connected to a c power supply internal batteries charging LED off batteries charged LED blinking charge level of batteries lower than 30 LED on internal batteries the device must be connected to the a c supply for recharging ECG recording in manual mode ECG recording in automatic mode setup mode access to configuration menu ECG recording in PC ECG mode automatic sensitivity the device optimizes the ratio between n channels and available space sensitivity 5 mm mV sensitivity 10 mm mV sensitivity 20 mm mV LED on filter on paper speed 25 mm s paper speed 50 mm s LED on electrodes not connected or insufficient contact saturation Paper compartment cover IR interface Connector for the CF type patient cable protected from defibrillation as indicated by the symbol 119 Reset key 3 allows normal operating conditions to be restored in the event of an error that cannot be managed using the other keys Battery charger connector Data plate In the event of communicating with Authorized Assistance Centers refer to the data indicated Batter
3. blinking Function selected active Out of paper or paper cover open 27 5 5 Troubleshooting The following table summarizes problems which may occasionally occur and their causes Problem Cause Drift of the isoelectric line Use of electrodes other than originals Use of electrodes in saturation Insufficient electrode skin contact Electrode surface dirty Patient moving Interferences of the electrical supply Voltage generator too close presence of other clinical instruments e g X rays Ultrasound etc Patient in contact with metallic parts or with other persons Muscle tremor Patient not relaxed Loose or improper Peripheral electrodes Improper paper flow End of paper roll Paper roll incorrectly positioned Use of improper paper Impossible to perform ECG analysis Signal too unstable or noisy Not possible to copy ECG e Recording interrupted before 10 seconds Excessive noise on the ECG defective patient cable defective electrodes 28 6 Maintenance 6 1 Self test Periodically carry out the self test procedure which permits a functional check of the writing system electronic parts of the keys and of the LEDs In the event of error messages contact the CARDIOLINE Authorized Assistance Center which will do whatever is necessary to eliminate the causes of the malfunction Access to the self test menu is accomplished from the setup mode Before starting the self test proce
4. 99 5 mm mV 10 mm mV and 20 mm mv During printing the sensitivity of recording on paper is indicated by the height of the calibration impulse that precedes each lead and is recorded on the information line Note if you select O the sensitivity is set automatically by the device in a way that optimizes the recording over the entire height of the paper In this case a sensitivity of 2 5 mm mV may be used This option is recommended during multi channel printing To know how automatic sensitivity is determined see the paragraph Technical Characteristics Recording filters If necessary it is possible to activate filters capable of improving the legibility of the signal without modifying its morphology Activation of the filters has an effect on the printed signal To guarantee a correct and accurate analysis any automatic interpretation of the trace is performed always and only on the non filtered ECG signal he to insert the filters corresponding LED on The filters available have been designed to reduce the effect of both mains disturbances and muscle tremors The special filter against drift of the isoelectric line ADF is always inserted During printing the filters inserted are recorded on the information line Caution the use of the filters of your ECG is very effective for attenuating disturbances and does not reduce the diagnostic content of the traces Nevertheless it is recommended to eliminate the cause of th
5. channel printing and filters 500 samples s channel in calculation and filters Resolution 5 uV bit ECG leads 12 standard cabrera leads ECG memory 10 seconds for each lead in auto isochronous Recording sensitivity manual 5 10 20 mm mV 5 automatic dependent on number of channels being printed Writing system Thermal printer 8 dot mm Usable print height 50 mm Print channels 1 3 optional Print format 1 2 3 optional Paper transport speed 25 50 mm s Heat sensitive paper rolls length 15 m gridded pack of Z Fold length 18 m page 60x75 mm gridded Filters Mains interference Modified digital notch filter 50 60 Hz Anti drift digital high pass 0 5 Hz linear phase Serial interface Infrared Keyboard Membrane with functional keyboard Interpretation program Parameter calculation optional Type of use continuous Operating modes manual acquisition and printing in real time automatic simultaneous acquisition Battery Capacity Internal battery 3 hours in 1 channel mode Recharging time Internal battery 14 hours 100 32 Housing protection IP 20 category Ambient conditions operation Ambient temperature from 10 C to 40 C Relative humidity from 25 to 95 without condensation Atmospheric pressure from 700hPa to 1060 hPa transport and storage Ambient temperature from 10 C to 40 C Relative humidity from 10 to 95 without condensation Atmospheric pressure from 500 to 1060 hP
6. is necessary to have an Authorized Assistance Center perform the following checks Y Y Y Y paper drive speed calibration every year cleaning of the paper compartment the paper present sensor and the writing system every year checking all the cables and connectors every year by means of an ECG simulator general check on functional efficiency of the device and leakage current every 2 years Technical information et medical devices SpA will supply circuit diagrams a list of components and information needed to enable the repair of user serviceable parts when requested by qualified persons 31 7 Technical Specifications Service power supply AC mains with external power supply 230V410 50 60 Hz available also 115V 10 50 60 Hz device with ower supply specified class II second REF type 6308 Maximum current 100 mA at 117 V 10 50 mA at 230 V 10 Mains protection Fuse TO 5A Internal power source Set of rechargeable NiMH batteries 8x1 2 Vdc 1500 mAh Battery protection PolySwitch 1 5 A 40 C in ambient conditions Internal power supply Pico fuse SHF SLO BLO T 2 A Littelfuse protection Applied part CF type Defibrillation protection Internal Input dynamics 300 mV 0 Hz 5 mV in pass band Input impedance gt 100 MQ on each electrode Common mode rejection gt 100 dB Frequency response 0 05 150 Hz 3dB without filters Time constant 3 35 Acquisition 11 bit 1000 samples s
7. rin SETAE NEEG 29 6 2 Replacement of the heat sensitive paper ocococccccncncncnncncncnnnnnnnnnos 29 6 3 How to clean the device and the electrodes ocococcccccccncncocononnnnnnos 30 6 4 How to replace the batteries oooococccccnccncncnconnnnnnenennnncncncnnnnnnnnnanes 30 6 5 Periodic checks iii A a A Seca 31 Technical information ocococncncncnnncncnncnnonennnnnnanrnnnnenenrrnnnnnanrnrnranenenes 31 7 Technical Specification S encore Aa arene a 32 Basic accessories SUPplied ocococncncncncncnnnncnnonennnnrnrnnnnananrnrnrnrnrnnnnnes 33 1 Introduction ar600 embodies the features of reliability modularity versatility and upgradability that characterize the latest generation of CARDIOLINE electrocardiographs ar600 is a portable electrocardiograph with dual power supply mains and rechargeable internal batteries which in the basic configuration allows Y recording of an ECG in either automatic or manual mode Y printing the ECG on 60 mm single channel format paper using a high resolution thermal print y storing the most recent ECG recording in automatic mode and printing additional copies of the ECG as required Thanks to the flexibility of the software used and to the infrared interface the ar600 can be adapted at any given moment to suit your individual requirements The range of options offered is particularly generous and there are no restrictions or constraints as the selection can be made either at t
8. CARDIOLINE ar600 user manual CE 0470 English This User Manual is prepared with the objective of providing the user with all of the information necessary to obtain the best use of the CARDIOLINE ar600 Together with a description of the equipment s functions the following documentation will be found Certificate of Guarantee General information CARDIOLINE is a registered trade mark et medical devices SpA All rights reserved et medical devices SpA ITALY et medical devices SpA in its continual pursuit of technological improvement and customer satisfaction reserves the right to modify this publication without notice at any time um_ar600_cardioline_01_eng1 doc Rev O1 sr GZ 07 09 2005 Ref 36519094 1 IMEFOGUCTION vicio a E A A A cote dmnadiebaaiian 5 1 1 How to read the manual a ociocinioiin sin ir e aa 6 1 2 Information and recommendations related to safe USE asce 7 1 3 The electrocardio graphs iccisscccccsctedsecedaecseangiserareiecadaseneae dE 9 Front VIS Wei in ias 9 Side VIEW and DOOM ici icici ne caewenc sta chee i aaa 9 Parts symbols ANd COMMANAS ceeeeeeeeee eee e eee ee eset eeeeeeeeeaeaeaeaee 10 2 Installation and initial preparation ccceeeeeee eee eects eee eens ee eeeaea eae 12 2 1 Selecting the installation Site cece eeee eect eee eee tees enna ee eeeaeaee 12 2 2 Loading the heat Sensitive PaPer cceeceeeeee cece eens ee eeeeeeeeeeeeeeeeee 12 If USING rOllS
9. Of paper eee ee cece eee e eee e eect teens nena eee eee a EATE 13 If USING PACKS OF PAPEM mina canedie seas decd AA 13 2 3 Power supply control and management of the internal batteries 13 Recharging the batteries cccceeee eee e eee eee eee eee teense nena ea eeeaeaes 14 Battery charger precautions for USC ceceeee sees eens tees tees ee eeeeeeenes 15 2 4 How to switch on the electrocardiograph 0 eceeeeeeeeeeeeeeeeeeeees 15 2 5 How to switch off the electrocardiograph eceeeeeeeeeeeeeeee enna es 15 AUTO POWER Off esis cceseecssseacaiuseradecanscinaeaiindan axnentas EE CENNE ANE ENEE SREE 15 2 6 Setup of the electrocardiograph cococococcccncnconononenanacanananancnnnannnes 16 How to access the Setup Menu cceceeeeeeeeee eect eset eens eens ee eaeeeaeaes 16 How to Change the SetUpPisiiconnaisi cit 16 Selections available sasen otr AEE 16 How to quit the Setup Menu cccceeeee cece e eee eee e eee eee ee ee eeeeeeeeeaea ed 18 3 Preparing for an ECG recordinQ occccccocococoncnnnnnnnancncnnnnnnnrnrnrnnanennnanans 19 3 1 Connecting the patient Cable cece ee cece ee eee e eee eee eee ee ee ea ea es 19 3 2 Preparing the patient and applying the electrodes eeeeeeee es 19 3 3 Selection of recording characteristics speed sensitivity filters 20 Speed of recording ON Papel ccececeeee cece eens este tees eee eeeeeeeeeeeeaeaeaeas 20 Sensitivi
10. a Dimensions 250 x 60 x 185 mm length x height x depth Weight 1000 grams without paper Conformity to standards EN 60601 1 1990 EN 60601 1 A1 1992 EN 60601 1 A2 1995 EN 60601 1 A13 1995 General standards for safety of electromedical equipment EN 60601 1 2 1993 Standards on electromagnetic compatibility of electromedical equipment EN 60601 2 25 1995 Particular safety standards for electrocardiographs EN 60601 2 51 Ed 1 2001 Particular standards on essential recording and analysis performance safety of single and multichannel electrocardiographs Basic accessories supplied patient cable cod 63050025 6 suction cup electrodes cod 66030163 4 peripheral electrodes cod 63030105 bottle gel 260 ml cod 66020002 1roll paper 60mm x 75m cod 66010037 frequency count gauge user manual cod 33 34 Page intentionally left blank CARDIOLINE Marketing amp Sales Head Office Strada Nuova Rivoltana 53 20060 Vignate MI ITALY tel 39 02 95 05 181 fax 39 02 95 66 013 e mail etmed etmed biz www cardioline biz
11. ally operated beds etc that could be a source of excessive interference and ECG signal distortion if it is impossible to position the electrocardiograph away from other electrical equipment switch off such equipment when recording an ECG Also observe the ambient operating conditions when recording ECGs record in a room where the temperature is between 20 and 25 degrees Centigrade This precaution prevents the patient from feeling cold which could increase shivering and contribute to muscle tremor Avoid exposing the equipment to extreme temperatures excessive dust or dirt and very salty or humid environments refer to the ambient conditions described in detail under the Technical characteristics heading 2 2 Loading the heat sensitive paper CARDIOLINE ar600 is able to reproduce the ECG signal both on heat sensitive paper in rolls and on heat sensitive paper in packs No special setup procedure is required for either This sections gives the instructions for the correct loading of both types of paper 12 If using rolls of paper a Using a coin or similar instrument open the paper compartment and remove the roll guide hub If replacing a depleted roll recover the hub before throwing away the core of the previous roll b Slot the hub into a new roll of paper 1 and locate in the paper compartment positioning the pins in the sockets 2 Ensure that the black mark on the paper is on the lower part of t
12. amage to the device or any other effect on it caused by the use of unsuitable paper Do not subject the device to impact or excessive vibrations Do not allow liquids to penetrate inside the device If this should accidentally occur have the functional efficiency of the device tested by a Qualified Assistance Centre before using it again Make sure that the value of the supply voltage corresponds to that indicated on the data plate of the device If you are using the device in connection with others ensure that all connections are made by skilled persons all connections comply with safety regulations all other devices connected respond likewise to regulations Non compliance with regulations can cause physical harm to the patient connected and to the person operating the device Should it be difficult to obtain the necessary information for assessing the risk of the individual connections apply directly to the manufacturers concerned or avoid making the connections If other equipment is used connected directly or indirectly to the patient check the possible risks caused by the sum of the leakage currents on the body of the patient The device is protected against defibrillation discharges according to standards IEC 601 1 25 to ensure that the signal is restored use only original electrodes or electrodes responding to IEC and AAMI standards If an electrosurgical scalpel is in use the patient cable should be disconnected from the devic
13. ant CE0470 mark 1 1 How to read the manual In order to ensure the ar600 is operated in a safe and correct manner and to appreciate its ease of use and high reliability the user instructions must be read carefully This documentation describes the functions of your electrocardiograph including those provided by all the possible options available It is therefore possible that some of the functions described may not be present in the model you have purchased For details of the options consult the firmware configuration chart which accompanies each individual appliance v This symbol allows you to identify the functions not provided on all models which must be requested specifically at the time of purchase This symbol allows you to identify the functional behavioral and operational aspects that may be programmed by the type of configuration selected during the step of Installation and initial preparation setup of the electrocardiograph 22 When a given key is depicted in the body of a sentence or a paragraph press the corresponding key on the appliance to perform the action The structure of this manual allows you to approach the use of the electrocardiograph according to your own level of experience If you are already familiar with CARDIOLINE equipment the initial fast track part of each paragraph will allow you to begin working immediately If you continue reading the paragraph however you will see that the indiv
14. ardiograph 5 1 Disconnected electrodes potential presence of defibrillation Saturation events are controlled and monitored by your electrocardiograph The operation of the electrocardiograph depends on the current operating phase Stop phase Y LED A blinking critical electrodes contact It is possible to proceed with the recording the critical electrodes are indicated on the print report in the information line for example A L 1 indicates the critical nature of the left arm electrode and of the electrode C1 Y LED A on electrodes disconnected saturation It is not possible to start an automatic recording A manual recording may be started the disconnected electrodes are indicated on the print report in the information line and a flat signal will be reproduced on paper corresponding to the lead that cannot be acquired due to the absence of an electrode for example A 1i indicates the saturation of the left arm electrode and of the electrode C1 Manual recording phase The event is indicated as in the stop phase When normal conditions have been restored the signal is centred Automatic recording phase If the event is detected during acquisition 10s the ECG is stopped and automatically returns to the stop phase If the signal is already in the memory printing continues without interruptions The indication of the event is the same as in all the other phases Defibrillation The LED lights up A See
15. back of the device The battery charger is protected against short circuits by an internal fuse not replaceable and against overheating Caution the battery charger is a class II power supply and does not require earthling of the electrical system Caution when the device is connected to the mains the internal batteries are recharged automatically even during use To gain maximum benefit from the characteristics of the dual power supply system follow the indications given below Recharging the batteries The batteries must be recharged when the LED e begins to blink signifying that the reserve charge is lower than 30 Connect the electrocardiograph to the mains LED turns on Complete recharging of the batteries requires about 14 hours The batteries can be recharged in part or the device can be kept connected permanently to the mains For longer life the batteries should be allowed to run down and recharged completely at least every two months A complete recharge allows the recording of up to 500 complete ECGs automatic recording mode 3 channel print format speed 25 mm s When recording with single channel print format the number is reduced to 250 If the batteries have completely run down LED e lit it is still possible to make an ECG recording by connecting the device to the mains The average life of the batteries is more than 300 complete discharge recharge cycles Caution do not dispo
16. ccess the Setup Menu De lt gt jie to select setup mode LED e on he to print the menu and the active setup How to change the setup Accessing the setup menu a page is printed which shows the list of the available setup options The active setup is highlighted by two square brackets Press the key associated with each option to change the selection Selections available Print format Status Setup Option selections avaliable change selection Up to three print formats are available 1 channel per page 2 channels per page 3 channels per page The appendix illustrates examples of recordings in different formats see Print formats examples 16 The format selected will be applied to all the recordings in manual and automatic mode Automatic calculation of ECG parameters ECG measurements Status Setup Option selections available change selection Y Calculate parameters The program for automatic measurement of the ECG parameters allows a report of the principal measurements calculated to be obtained at the end of each automatic recording Selecting Yes the program will be performed automatically at the end of acquisition selecting No no measurements will be calculated PC ECG recording mode Status Setup Option selections available change selection The PC ECG function allows real time viewing of the twelve leads on the screen of your Computer us
17. dure ensure that there is paper in the machine Si to select setup mode LED eS on to print the menu to access the self test menu Be A start LED test all the LEDs light up in sequence start keyboard test follow the printed instructions TOY F F F F start printer test two triangular waves are printed the characters available in memory signals with different speeds and sensitivities Anomalies of the printing system are detectable by non continuous lines start memory test a message concerning the memory status is printed he a print ECG information chart Notify the information listed in all communications with the Assistance Centers he to quit the menu 6 2 Replacement of the heat sensitive paper When the heat sensitive paper is used up the device stops and any attempt to start recording is blocked see paragraph Print system control Out of paper 29 To replace the paper proceed as indicated in the paragraph Installation and initial preparation 6 3 How to clean the device and the electrodes To clean the device use a cloth dampened with water or denatured ethyl alcohol Do not use other chemical products or household detergents For the electrodes remove the electrodes from the patient cable and wash under running water Do not scratch the electrodes and do not wet the leads box and the patient socket Note the device cannot be sterilized The electrodes can be sterilized wit
18. e At all events when defibrillators or high frequency surgical devices are being used at the same time it is essential to take the greatest care If there is any doubt concerning their use disconnect the ECG patient cable temporarily The device recognizes the impulses generated by a pacemaker and does not interfere with its operation as prescribed by standards in use at the time of drafting this manual Periodically check the efficiency of all accessories and of the device itself Use the built in test function to make a first check of the equipment s efficiency Contact the Authorized Technical Assistance Center whenever the equipment appears to be malfunctioning To ensure a longer life of your device it is necessary to have it checked periodically by an Authorized Assistance Center Caution do not use the electrocardiograph for intracardiac applications or for monitoring activities in the operating theatre Caution do not use the device in the presence of anaesthetics or inflammable gases Caution devices for medical applications must be used only by persons who by virtue of training or practical experience are able to ensure maximum safety and effectiveness in operation Every operator must become familiar with the instrument before using it on a patient Caution the indications obtained using automatic interpreting programs or other diagnostic aids must be passed and countersigned by a qualified medical person Cautio
19. e interference and not just the visible effect on the trace see paragraphs Troubleshooting Initial preparation 21 4 Recording a resting ECG 4 1 Recording in manual mode The selected leads are recorded and printed on paper The signal is recorded in real time i e acquisition and reproduction of the trace are simultaneous When operating in manual mode it is possible to establish the duration of registration independently for each group of leads starting from Di D1 D2 D3 in multi channel print format to select manual mode LED S on jie to start the recording If the signal has not yet been initialized the LED 4 lights up momentarily e lt a je a to change the ECG leads being printed during recording Q jie E to interrupt the recording stop Note during a manual recording it is possible to alter the recording characteristics speed sensitivity filters Caution starting a manual recording cancels the last trace recorded in automatic mode 4 2 Recording in automatic mode All of the ECG leads are simultaneously recorded 10 seconds The signal printed on paper refers to the same time period and is stored in memory An automatic recording allows you to run calculation and analysis programs on the traces available ECG measurement option to obtain a copy of the recording and to transfer the test to a Computer PC archive option to select automatic mode LED Y on
20. electrodes Standard positioning of the electrodes V1 on the 4th intercostal space along the right parasternal line V2 on the 4th intercostal space along the left parasternal line V3 on the 5th rib between V2 and V4 V4 on the 5th intercostal space on the left hemiclavicular region V5 on the left anterior axillary at the same level as V4 V6 on the left mid axillary at the level of V4 peripheral electrodes generally a few centimeters above ankles and wrists Warning make sure that the conductive portions of the electrodes are not touching each other or other metallic parts In any case series original electrodes of silver and silver chloride are designed and manufactured in order to minimize the likelihood of accidental contact between conductive parts and external metal objects Ensure that the machine is not affected by disturbances originating from the power supply network see paragraph Initial preparation 3 3 Selection of recording characteristics speed sensitivity filters Speed of recording on paper to select the speed corresponding LED on The possible choices are 25 mm s and 50 mm s During printing the speed of the paper flow is indicated by the width of the calibration impulse that precedes each lead and is recorded in the information line 20 Sensitivity of recording on paper Ww to select the sensitivity corresponding LED on The possible choices are
21. h oxide of ethylene 6 4 How to replace the batteries If the operation time in battery mode is considerably reduced or if it s no more possible to operate the recorder in battery mode the batteries must be replaced The battery lifetime is approximately one year Attention be sure to use original batteries containing protection circuit Attention When removing or inserting the batteries from the recorder make sure that the recorder is turned off and the A C power cord is disconnected from the mains otherwise the patient and the operator may be subjected to an electrical shock 1 Openthe battery compartment 2 Remove the batteries taking off the connector please remember to take note of connection polarity red black 3 Insert the new batteries and reconnect the connector observing the polarity red black 4 Close the batteries compartment Before using the device refer to the recharge instruction see Recharging the batteries Attention the non respect of the batteries connection polarity may cause serious damages to the device as well as the warranty validity failure Attention do not dispose of spent batteries as ordinary refuse or litter Use only original batteries provide from the manufacturer 30 Note the removal of the battery pack doesn t cause the data loss 6 5 Periodic checks To ensure correct and long lasting operation of the device it
22. he moment of purchase or later on at your clinic or surgery without having to interrupt day to day activity In just a few minutes your ar600 can be equipped with multi channel option for printing the ECG signal in 1 2 and 3 channel format ECG measurement option automatic ECG parameter measurement program PC archive option Archival storage of the ECG in a personal computer running the CARDIOLINE software for the ECG computerised management The data upload to the PC is made by use of the wireless IR interface no direct connection to the PC is required PC ECG option real time display of the 12 ECG leads on a personal computer screen endowed with CARDIOLINE software for the ECG computerised management The software can offer an optional module for automatic interpretation of the ECG signal CONGRATULATIONS ON YOUR PURCHASE Your new computerised electrocardiograph CARDIOLINE has been designed and built in compliance with the applicable regulations in force at the time when et medical devices SpA Cavareno Trento ITALY drew up this manual et medical devices operates in accordance with the requirements for quality management systems defined by EN ISO 9001 2000 and EN ISO 13485 2003 standards The system is covered by a Nemko Certification AS Cert N 800278 Your new electrocardiograph has also been built in compliance with the Medical Device Directive 93 42 EEC and is therefore marked by the relev
23. he roll c Close the cover positioning the paper between the rubber roller and the casing of the device 3 If using packs of paper a Using a coin or similar instrument open the paper compartment and remove the roll guide hub To avoid accidentally losing the hub store it in a safe place b Prepare a new pack 1 and position it in the compartment 2 Ensure that the black mark on the paper is on the lower part of the pack c Close the cover positioning the paper between the rubber roller and the casing of the device 3 Warning use only original heat sensitive paper or paper approved by the manufacturer The use of paper that does not respond to the manufacturer s specifications could jeopardize the correct operation of the device 2 3 Power supply control and management of the internal batteries Your electrocardiograph uses a dual power supply system a c mains and NiMh rechargeable internal batteries 13 The rechargeable batteries come as a pack of 4 4 elements housed in the battery compartment on the bottom of the device and are protected against short circuits Caution before using the device it is necessary to go through a complete cycle of recharging of the batteries However it is advisable to connect the appliance to the mains during the installation procedures To connect the electrocardiograph to the mains connect the battery A charger provided to the connector EE on the
24. idual aspects of the operation are discussed in more detail The manual gives detailed information on the use of the model ar600 for typical ECG procedures and an introduction to the use of particular functionalities involving interaction with software and a Personal Computer For instructions on the use of the software applications for Personal Computer consult the special online guides Y The quick guide to the electrocardiograph fies to obtain the printout sums up the operations linked to the single commands presented in the manual Further information and clarifications can be requested directly from CARDIOLINE Product Support Strada Rivoltana Nuova 53 I 20060 Vignate MI ITALIA e mail et service etmed biz tel 39 02 95 05 181 fax 39 02 95 66 013 6 1 2 Information and recommendations related to safe use Always use the device according to the instructions in this manual The device is equipped with a set of standard accessories For reasons of safety reliability and conformity with the Medical Devices Directive 93 42 EEC use only original accessories or accessories approved by the manufacturer The device is equipped with a special long life thermal print head writing system which allows maximum writing precision To avoid frequent and costly replacements and repairs always use the original paper or paper approved by the manufacturer The manufacturer does not accept responsibility for any d
25. ing R T E 4057 Real Time ECG software Selecting Yes it will be possible to select the PC ECG operating mode from the keyboard in addition to the traditional automatic and manual modes selecting No this selection will not be possible Saving to Personal Computer archive i Status Setup Option selections available change selection Using the PC Archive function in association with CARDIOLINE software a trace recorded and stored in automatic mode can be transferred to a computer Selecting Yes the action activate transmission to PC is associated with the key selecting No the associated action is print copy of last recording 17 ECG report length Status F Setup Option selections available change selection It is possible to select the length of the signal to be represented on paper during automatic recordings indicating the number of pages to be used Two options are available 1 page per lead or group of leads if a multi channel format has been selected 2 pages per lead or group of leads if a multi channel format has been selected The option selected will be applied to all recordings in automatic mode Mains frequency Status Setup Option selections available change selection Mains frequency 50 60 To ensure correct operation of the device the program must be set to recognize the mains frequency adopted in the area of use Two options are availab
26. it is necessary to use protected electrodes To ensure that safety conditions are respected use only original accessories 3 2 Preparing the patient and applying the electrodes A careful preparation of the patient and the correct positioning of the electrodes are at the foundation of an ECG recording of high quality Y First make the patient comfortable he should be warm and relaxed as much as possible he should lie on his back on an examination bed or table of adequate size with his arms and hands relaxed along the sides of his body this will minimize the likelihood of trace interference originating from muscle tremor Y Thoroughly clean the skin where the electrodes will be placed with alcohol or ether Y Connect each unipolar plug of the patient cable distinguished by colour coding to the respective electrodes observing the colour position relationship indicated below Colour Symbol Electrode position Red R right arm Yellow L left arm Green F left leg Black N right leg White Red Ci vi White Yellow C2 V2 White Green C3 V3 White Brown C4 V4 White Black C5 V5 White Violet C6 V6 19 Y Apply a small amount of electrocardiograph conductive gel on the skin area that will be in contact with the electrode spreading it carefully this procedure is not necessary when using disposable electrodes with built in gel v The following figure shows the standard positioning of the
27. le 50 Hz 60 Hz The option selected will have an effect both on the battery charging process and on the operation of the filters used to reduce mains interference Self test Status Setup Option selections available change selection s ee ee Oo To verify correct operation of the electrocardiograph the self test routine can be run by accessing the dedicated menu For details see Maintenance Self test How to quit the Setup Menu Y he EE to quit setup mode Select a new operating mode to continue 18 3 Preparing for an ECG recording Below are described the operations to be performed prior to recording a resting electrocardiogram with the CARDIOLINE ar600 electrocardiograph In particular indications are given on connecting the patient cable suitably preparing the patient applying the electrodes Moreover the necessary procedures for choosing the correct recording parameters such as speed sensitivity and inserting the filters are illustrated 3 1 Connecting the patient cable Connect the terminal plug of the patient cable to the connector a identified with the symbol A positioned on the right side of the device Note to avoid breaking the patient cable remove it from the connector without tugging it gripping it by the plug Warning the device is internally protected against defibrillation discharges in order to guarantee the resetting of the signal
28. n use only original battery chargers as indicated alongside the connector and in the paragraph Accessories supplied The original battery chargers ensure the electrical isolation of the patient and the operator guaranteeing essential conditions of safety Do not use replacement accessories that have not been approved by the manufacturer Caution the device is provided with an IR interface for the transfer of data to other devices The IR interface must not be masked even accidentally as this will adversely affect its capability and its operation interrupting and preventing the correct flow of data The manufacturer will be responsible for the safety and correct use of the devices only if o modifications and repairs are performed by the manufacturer or by an Authorized Assistance Center o the a c power supply of the building responds to current regulations o the device is operated in accordance with user instructions o the accessories used are those approved by the manufacturer 1 3 The electrocardiograph In order to simplify the installation and the use of your electrocardiograph it is recommended that you become familiar with the component parts and method of operation Front view Parts symbols and commands 1 The keyboard Function ke
29. o more than one meter Avoid placing objects between the two interfaces 4 3 Recording in PC ECG mode Mi The twelve ECG leads are displayed in real time on your Computer screen where thanks to the CARDIOLINE software it is possible to perform all the ECG recording operations Your ar600 therefore becomes an acquisition system based on a PC For details on the use of the application software consult the specific manual he Place the electrocardiograph in position with respect to the infrared adapter previously connected to the PC oe iw Sau to select PC ECG mode LEDs e D Ve iit a lt E to start transmission During transmission the LEDs ef DO 08 blink jie to end transmission Caution to assist correct data transmission position the IR adapter for PC at a distance of no more than one meter Avoid placing objects between the two interfaces 4 4 Defibrillation In the case of defibrillation the LED 4 lights up Within 10 seconds of the discharge the signal is automatically reset if the paper reproduction of the 24 signal was activated in manual mode Always remember to avoid direct contact between the electrodes of the defibrillator and those of the electrocardiograph The approved electrodes supplied as original equipment with your electrocardiograph were developed so as to minimize the risk in case of accidental contact 25 5 Management and control of the functions of the electroc
30. paragraph Defibrillation 5 2 Batteries low on energy or no charge The batteries must be recharged when the LED ea begins to blink the reserve charge is lower than 30 Follow the indications supplied in the paragraph Installation and initial preparation 26 5 3 Print system control Out of paper The correct closure of the paper cover is monitored and depletion of the thermal paper generates a warning signal During a recording printing is automatically blocked and the LEDs amp blink for 5 seconds 5 4 Status messages amp errors indication description and related event Below are listed the various error messages printed on paper and the behavior of the LEDs in case of unusual events Each message and LED is correlated to a specific condition or operating phase Messages Message Status event description Measurements or analysis impossible due to the poor quality of the signal It is not possible to perform automatic calculation of the ECG measurements because the signal is too noisy No ECG trace in memory Impossible to obtain copy of the last recording LEDS Description Status event description e blinking Batteries low on energy e alight No battery charge eh alight Disconnected electrodes or potential defibrillation IN blinking Critical electrodes Standby for signal centering prior to start printing Qe blinking The signal recorded in automatic mode has been memorized eS D O
31. red in the memory Caution switching off is not enabled 1 during the transmission of an ECG to a PC 2 during the self test routine 3 if setup mode is active In these cases first stop the device and then switch off Auto power off To preserve the battery charge the electrocardiograph is provided with an auto power off function that will activate automatically depending on the amount of power still available and on the operating mode selected The procedure is activated only after the current operation has been completed After 10 min have elapsed without any key being pressed reserve power gt 30 15 After 1 min has elapsed without any key being pressed reserve power between 15 and 30 LED AF blinking After 10 sec have elapsed without any key being pressed reserve power lt 15 LED alight If the auto power off function is activated the current ECG and settings if applicable will be stored in memory Auto power off is inhibited if a recording is in progress in PC ECG mode during the self test routine during setup 2 6 Setup of the electrocardiograph Some of the characteristics of your electrocardiograph can be set according to individual preference and convenience The characteristics that can be configured are listed in the Setup Menu Within the menu it is possible to activate the self test function of the device see paragraph Maintenance How to a
32. se of spent batteries as ordinary refuse or litter Use only original batteries provide from the manufacturer The battery lifetime is approximately one year 14 Battery charger precautions for use The battery charger can be damaged if dropped struck or tampered with Do not immerse the battery charger in water or other liquids When using it do not place it on or near sources of heat Do not damage or tamper with the cables for connection to the mains and to the electrocardiograph Connect the battery charger to the electrocardiograph only by means of the connector provided Use the battery charger only at the specified mains voltage If the battery charger provided is not compatible with your mains supply ask the nearest Authorized Assistance Center for a suitable model 2 4 How to switch on the electrocardiograph a 0D je Ex for at least two seconds he The LEDs corresponding to the settings previously selected will light up you can proceed Caution if the LED AF remains alight or blinking internal power is insufficient and the batteries must therefore be recharged connecting the device to the mains see paragraph Power supply The batteries are recharged even if the device is in use 2 5 How to switch off the electrocardiograph he The LEDs corresponding to the selected settings will extinguish The memorized ECG if any and the settings for the last recording are sto
33. ty of recording ON PAPeTF ooccccccnconnnnnnnnnnnnnnncnnnnnananrnnnnanannnnns 21 Recording filter Sissis a aca 21 4 Recording a resting ECG secar scores a e lt act 22 4 1 Recording in manual mode 0ooccccccocnnnnnnnannncnnanencnnnnnanrnrnrnnnnanananan 22 4 2 Recording in automatic MOde occccccncncnnnnnnnnnnnncncnnnnnnnananennnnanannnnns 22 Automatic calculation of the ECG parameters Mi is 23 Copy of an automatic ECG recording H oococccncoconnnnnnnnnnnanannnnnnnn nn 23 Saving an automatic ECG recording to archive on a Personal Computer A peace AN TE 24 4 3 Recording in PC ECG mode vi O O AN 24 4 4 Defibrillation AAN EANN Mee 24 5 Management and control of the functions of the electrocardiograph 26 5 1 Disconnected electrodes potential presence of defibrillation 26 Stop POSE iii a han ete bustles aia seek beads 26 Manual recording phaSe ccececeeee eee eee eects eens ease ease ease eeeeeneeaeae 26 Automatic recording Phase cccceeee cece eee e reese eee eee e eee ee ee eeeeee teens 26 DetiDrilatiOn 000 A EEA 26 5 2 Batteries low on energy Or NO Charge ccccccncncncnencnncncnnnnnanenenennnnos 26 5 3 Print system control Out Of Paper occccccccncncncncncnncnnnnnnnnnanenennanens 27 5 4 Status messages amp errors indication description and related event 27 5 5 TroubleshootiNg wiii aei aiaia Aaa 28 M intenanCe risers iida aaan A E A E A E A eebaee 29 Ged Self test ini S aAA EEA AA A
34. ue to the poor quality of the signal This situation may be due to excessive noise of the ECG trace or to incorrect positioning of the electrodes Copy of an automatic ECG recording The ECG recording in automatic mode and the respective analysis if processed automatically are automatically memorized and can therefore be reproduced on paper an unlimited number of times oer he to start printing a copy 7 he EA to interrupt printing stop If the memory does not contain valid data the message No ECG trace in memory is printed Note memorization of the trace is performed without filtering the signal notwithstanding the operation of filters during the recording The parameters may therefore be modified before printing inserting the filters speed and sensitivity Caution each new acquisition cancels the ECG trace previously stored in the memory 23 Saving an automatic ECG recording to archive on a Personal Computer ME Your electrocardiograph is capable of transferring the stored ECG test to a Personal Computer equipped with CARDIOLINE software For details on the use of the application software consult the specific manual pe Place the electrocardiograph in position with respect to the infrared adapter previously connected to the PC he to start the transfer jie to interrupt the transfer before the end Caution to assist correct data transmission position the IR adapter for PC at a distance of n
35. y compartment cover 11 2 Installation and initial preparation This section describes the operations to be performed prior to using your new CARDIOLINE ar600 electrocardiograph Suggestions are given for selecting the installation site and recommendations for safe use in conformity with current statutory regulations are indicated Also introduced are the operations involved in preparing the electrocardiograph for use such as loading the heat sensitive paper power supply control and management of the internal batteries switching on and off setup 2 1 Selecting the installation site The ar600 electrocardiograph complies with European directives on electromagnetic compatibility The absence of emissions damaging to radio and telecommunications transmissions is therefore assured as also is protection from interference emitted by other systems and equipment Nevertheless in order to protect your device from other equipment not in conformity with the aforementioned directives avoid the use of mobile phones in the vicinity place the electrocardiograph as far as possible from electrical power lines or from sources of static electricity The ECG signal can in fact be disturbed if the electrocardiograph is situated in proximity to sources of high voltage or electrical lines avoid placing the electrocardiograph close to other diagnostic or therapeutic equipment e g X ray machines ultrasound machines electric
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