Cardioline ar1200view - User manual
Contents
1. Peripheral electrodes generally a few centimetres above ankles and wrists Warning make certain that the conductive parts of the electrodes are not in contact one with another or with other metallic parts In any event silver and silver chloride electrodes are designed and manufactured in such away as to minimise the likelihood of accidental contact between conductive parts and external metal objects Ensure that the device is not affected by disturbances originating from the AC mains power supply see Initial preparation 4 3 Select recording characteristics operating mode display and print format speed sensitivity filter Operating mode M The available recording modes Operating mode depend on the active configuration of the electrocardiograph he to select the desired mode the corresponding choice is displayed on the screen The options available are Automatic Manual Personalized To change Personalize Mode see Settings During printing the active mode is printed on the information line of the printout 30 Automatic ECG All 12 ECG leads are recorded simultaneously 10 seconds The signal printed out refers to the same time period and is saved The selected leads are recorded and printed out The recorded signal Manual ECG is in real time i e the trace is produced simultaneously with its acquisition Personalize See Personalize mode for details Display and print format To se2. 1 Introduction 6 1 1 How to read the manual 1 2 Information and recommendations relating to safe use 8 1 3 The electrocardiograph 10 Front view 10 Side view and bottom 10 Parts symbols and controls 11 2 Installation and initial preparation 16 2 1 Selecting the installation site 16 2 2 Loading the thermal paper 16 2 3 Power supply control and management of the rechargeable battery 17 Recharging the battery 18 2 4 How to switch on the electrocardiograph 18 2 5 How to switch off the electrocardiograph 19 Auto power off 19 3 Preparation for use the menu 20 3 1 How to access the menu 20 3 2 Structure of the menu 20 3 3 Menu activated operation and personalization of the electrocardiograph 23 Personalize sas Ol 23 The ECG archive M 24 Settings 24 Tools 28 4 Preparing for an ECG recording 29 4 1 Connecting the patient cable 29 4 2 Preparing the patient and applying the electrodes 29 4 3 Select recording characteristics operating mode display and print format speed sensitivity filter 30 Operating mode M 30 Display and print format 31 Speed of recording on the display and on paper 32 Sensitivity of recording on the display and on paper 32 Recording filter 32 3 5 Recording of a rest ECG 5 1 Patient data entry 5 2 Recording in manual mode 5 3 Recording in automatic mode Automatic calculation of ECG parameters M Automatic ECG interpretation M Copy of an automatic ECG recording ECG memory savin
3. 25 Leads sequence The sequence of leads printed can be selected As well as modifying the order in which the leads are printed out the selection also influences the rhythm lead selection menu Three options are available 1 Standard 2 Cabrera 3 Personalize a special sequence can be set The type of processing of the ECG trace acquired in automatic mode can be selected The choice influences the type of document printed Two configuration menus are available linked to the type of automatic processing available ECG Parameters and ECG Interpretation Processing may also be disabled by selecting None Lead Sequence Inside the single menus f to enable disable a section ECG Parameters Summary represents the minimum report and cannot be de selected The following are reported date and time of recording patient data note field main ECG parameters calculated heart rate rhythm type P QT QTc PR V QRS and QTr wave amplitudes frontal vectors axes Analysis ST Measurements printout of table of ST depression values on the twelve leads Templates printout of templates relative to the twelve leads ECG Interpretation Summary represents the minimum report and cannot be de selected The following are reported date and time of recording patient data if inserted note field ECG parameters calculated frontal vector indication of normality Rhythm Analysis print rhythm strip
4. 6 5 Troubleshooting The following table summarises certain problems that may occur and the relative causes Problem Cause Isoelectric line drift Use of electrodes other than originals Use of electrodes in saturation Insufficient electrode skin contact Electrode surface dirty Patient moving Interference from AC mains supply Voltage generator too close presence of other clinical instruments e g X rays etc Patient in contact with metallic parts or with other persons Muscle tremors Patient not relaxed Peripheral electrodes adhering too tight Irregular paper transport End of paper roll Paper roll incorrectly positioned Use of non original paper Analysis impossible Signal too unstable or noisy No copy of trace Wrong copy setup Recording is interrupted before 10 seconds Real time operation mode Manual Autotimer Arrhythmia HRV If the memory option is enabled if the device is off after the last acquisition Abnormal signal Defective patient cable Defective electrodes 47 7 Maintenance 7 1 Self test Run the User self test procedure periodically This performs a routine check on the functional efficiency of the display the keys the writing system and the memory The user can also print out identifying information relative to the individual device In the event of error messages being displayed contact the CARDIOLINE Authorised Assistance Centre and a
5. If the signal is already buffered the print continues without interruption The event is indicated in the same way as for all other phases Defibrillation The OL symbol is displayed See Defibrillation 6 2 Batteries low or in need of recharging When the symbol is displayed the battery must be recharged the reserve charge is lower than 30 6 3 Print system control Out of paper Sensors verify the correct closure of the paper compartment cover and indicate when the thermal paper is depleted During a recording printout is 45 inhibited automatically and the messages Out of paper or Printer are displayed for 3 seconds approx 6 4 Status messages and error indication description and related event Listed below are the various error messages displayed and or printed on paper when abnormal events occur Each message is correlated to a specific condition or phase of operation Messages Message Description of status event Not Available Function or action not available for the selected operating mode Analysis nd Automatic ECG analysis cannot be performed due to excessive signal noise No data Impossible to obtain copy of the last recording A Critical electrodes Attention OL Disconnected electrodes or potential defibrillation Out of paper Paper finished insert a new pack roll Printer Paper compartment cover open or not properly closed Lh Low battery Ch Run down battery 46
6. M Warning To obtain a correct recording in Arrhythmia mode mode ensure that the battery and paper load are enough to perform the selected acquisition A recording in Arrhythmia mode allow to analyze in real time the ECG signal for a predicted period of time in order to detect potential abnormalities of the Rhythm in the time domain During the test if an abnormal rhythm is detected a printout of the events can be obtained in continuous until the rhythm become normal again the length of the printout depends on the setup At the end of the test or after every 5 minutes a complete report is printed full disclosure of the reference ECG lead selected by the menu with marker identification of the abnormal beats patient data summary table of the computed parameters Note connect only the electrodes related to the reference lead in order to increase the patient comfort After selecting Arrhythmia mode he UI To start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed h The patient data entry procedure now starts see Patient data entry h The display shows the time from the test start The test is automatically terminated at the end of the default time 5 minutes and the final report is printed out in any case every 5 minutes pressing the key stop 43 jie to interrupt stop 5 1
7. Automatic archive files are deleted automatically after successful transmission to a PC with the ArchPC function Auto transmission last ECG Yes last stored ECG will be automatically sent No no auto transmission Emergency only only last stored ECG acquired in Emergency mode will be automatically sent V HRV The following can be set duration of the test 1 to 5 minutes and reference lead for analysis analysis The following can be set number of recordings intervals duration of intervals i e time between recordings print delay timed prints and manually activated prints between two intervals are referred to a sample acquired 10 seconds earlier number of leads being printed twelve in format set three or six selectable The user can set the RR advance in percentage the RR delay in percentage the Print Advance how many seconds of signal to be printed as reference normal ECG before the first event min 2 sec max 10 sec the Print Delay how many seconds of normal ECG after the last event min 2 sec max 10 sec Arrhythmia monitor enable the printout of the abnormal ECG during the test Event Print enable the abnormal ECG printout during the test ARR Leads select lead full disclosure report Print Delay It could be possible enable disable 10 s print delay referred to a real time event 27 General Options Actions available Date Time o the date time progr
8. accidentally as this will adversely affect its capability and its operation interrupting and preventing the correct flow of data The manufacturer will acknowledge liability for the safety reliability and functional efficiency of the device only if modifications and repairs are performed by the manufacturer or by an Authorised Assistance Centre the AC mains power supply of the building responds to current regulations the device is operated according to user instructions any accessories in use are those approved by the manufacturer 1 3 The electrocardiograph Front view Side view and bottom Parts symbols and controls 2 Keyboard Function ke select start operating mode interrupt current operation stop Select operating mode Select ECG display format Select print format Messages amp Symbols displayed Associated LED LED on device connected to mains power internal battery charging full symbol battery charged part empty symbol battery power less than 30 empty symbol internal battery flat the device must be connected to the mains power for recharging Indicated electrodes not connected or insufficient contact saturation Automatic recording Personalized Automatic mode available formats 3 6 Manual mode available formats 3 6 Automatic mode available formats 3 3 R 6 Manual mode a
9. non filtered ECG signal he to install the filter on is associated with the corresponding symbol on the display The filters available have been designed to reduce the effect of both mains disturbances and muscle tremor The special isoelectric anti drift filter ADF remains permanently activated During printing the filter installed is shown in the information line Warning the filter of your ECG is very effective in attenuating disturbances and do not reduce the diagnostic content of the traces Nonetheless it is advisable to eliminate the cause of the interference and not only the visible effect on the trace see Troubleshooting Initial preparation 33 5 Recording of a rest ECG 5 1 Patient data entry to display the patient file at any time PATIENT DATA Patient ID 1234 Surname BROH Hare i JEMES Date of Birth 1270371974 dden Sex I Male Surnane 2 Blood Pressure 1 1260786 CrmHal Heisht 172 cm Meisht 7i kal Type 1 Caucasian Medicaments 1 DOPMIHA Hote 1 SMOKER Hord Dert Hane UTIC Cal Confira Inside the patient file he to display the New option On confirmation the displayed data are cancelled e g GD DI to move around inside the file and display the options associated with the Type jie to enter data 34 he to clear the text before the cursor to clear the text after
10. o Default Configuration o Self test User Display Keyboard Printer Memory About Service Only available to Technical Service 3 3 Menu activated operation and personalization of the electrocardiograph Listed below are the operating and configuration details associated with the single items in the menu To operate the menu refer to the heading How to access the menu Personalize mode M The menu allows one of the enabled modes to be added to the direct selection of traditional operating modes Automatic and Manual The mode selected is displayed in the lower left corner of the main screen Options Actions available Description _ _ The recording starts immediately pressing start key If the automatic V E interpretation is enabled analysis will be performed considering a mergency person of 35 years old gender male 23 The ECG trace is recorded and saved without any hard copy of the signal generated The steps and the quality of the recording are V monitored through messages in the display Thereafter the recording Paper saving can be printed or saved to PC archive Feature associated with memory option The twelve ECG leads are displayed in real time on your Computer V PC ECG screen where thanks to the CARDIOLINE software Real Time ECG j it is possible to perform all the ECG recording operations The ECG signal is acquired in continuous mode and then printed in compress
11. until the device is switched off Warning the number of tests in the memory and the percentage of space used can be checked on the main screen The message Memory full is displayed when the memory space is completely or close to completely filled After finishing the current operation free space in the memory by cancelling exams or transferring the archive to the PC ECG memory archive management M je lt to select the desired action 1 Display 2 Archive PC 3 Print List 4 Empty 38 he f to scroll pages if more than 1 he Oe to enable the find function research key last name jie to confirm the desired action For details of the options available see ECG Archive Saving to Personal Computer archive M Warning to ensure correct data transmission position the IR adapter of the PC at a distance of no more than 50cm Avoid placing objects between the two interfaces Your electrocardiograph is capable of transferring stored ECG traces to a Personal Computer equipped with CARDIOLINE management software For details on the use of the application software consult the specific manual If the Memory Option is not installed he Position the electrocardiograph close to the infrared adapter connected previously to the PC as illustrated in the following figure l ae he to start transfer If the Memory Option is installed The user can either proceed as d
12. which must be requested specifically at the time of purchase This symbol allows you to identify the functional behavioural and operational aspects that may be conditioned by the type of configuration selected during the step of Preparation for use the menu When a given key is depicted in the body of a sentence or a paragraph press the corresponding key on the device to perform the action The structure of this manual allows you to approach the use of the electrocardiograph according to your level of knowledge If you have already had experience with CARDIOLINE equipment the initial fast track part of each paragraph will allow you to begin working immediately In the continuation of the paragraph on the other hand the single aspects of operation are discussed in more depth The manual gives detailed information on the use of the model ar1200view in traditional 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 The quick guide to the electrocardiograph at power up the display shows the message Press 1 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 Supporto Prodotto
13. 0 Defibrillation If defibrillation occurs the symbol is displayed Within 10 seconds from the discharge the signal is automatically restored 44 6 Management and control of electrocardiograph functions 6 1 Disconnected electrodes potential defibrillation Saturation events are controlled and monitored by your electrocardiograph The response of the electrocardiograph depends on the current phase of operation Stop phase Y Symbol displayed critical electrode contact The user can proceed with the recording the critical electrodes are indicated in the print report on the information line for example A L 1 indicates the critical nature of the left arm electrode and of electrode C1 Y Symbol OL displayed electrodes disconnected saturation It is not possible to start an automatic recording A manual recording can be started the disconnected electrodes are indicated in the display and in the print report on the information line and a flat signal will be reproduced on paper where a lead cannot be acquired due to the absence of an electrode e g OL L 1 indicates saturation of the left arm electrode and of electrode C1 Manual recording phase The event is indicated as for 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
14. 5 Recording in ECG Autotimer mode Warning To obtain a correct recording in ECG Autotimer mode ensure that the battery and paper load are enough to perform the selected acquisition Operating in Autotimer mode the device can make timed recordings of the 12 standard leads or of a group of three user selectable leads After having selected ECG Autotimer mode jir lt a to start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed he The programmed recordings are in real time Together with the date time field details regarding the interval number and recording time format xx yy min are shown in the printouts as well as the 40 wording print from memory if this type of print has been previously enabled during setup he f to scroll the leads on the display during the test jie lt a to start manual recording inside an interval the print format corresponds to the format selected on the display to pause manual printing je to interrupt the test 5 6 Recording in paper saving mode If Paper Saving mode is selected the device performs and stores an automatic ECG recording including any ECG calculation and analysis programs option ECG Parameters ECG Interpretation without any printout After selecting Paper Saving mode see Operating mode he lt a to start the recording If the s
15. Analysis mode ensure that the battery and paper load are enough to perform the selected acquisition A recording in HRV mode allow to analyse the measurement of the heart rate variability in a predicted interval from 1 to 5 minutes and to printout a complete report full disclosure of the reference ECG lead selected by the menu patient data summary table of the variability parameters total R R intervals medium HR medium R R interval maximum R R interval minimum R R interval ratio max min standard deviation coefficient of R R variability number of R R intervals greater than 2 2s and not reported on the graph graph of the R R distribution in the time domain R R trend graph Note only the electrodes referred to the lead set for the test can be connected improving patient comfort After selecting HRV Analysis mode je lt a To start the analysis the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed 42 e The display shows the time from the test start The test is automatically terminated at the end of the scheduled time and the final report is printed out he f to scroll the leads displayed during the test based on the electrodes connected jie to interrupt stop No report is printed and the recorded data are cancelled he to print copy of the report at the end of the test 5 9 Recording in Arrhythmia mode
16. CARDIOLINE ar1200view User s Manual CE 0470 English This User Manual has been prepared with the objective of giving the user all the necessary information to make the best use of the CARDIOLINE ar1200view General information et medical devices SpA continuously in search of technological improvement and customer satisfaction reserves the right to modify this publication without prior notice at any time All rights reserved et medical devices SpA ITALY CARDIOLINE is a registered trademark of et medical devices SpA CARDIOLINE product support services For any questions about a CARDIOLINE product Y consult the documentation and other printed material included in the package Y consult any guidelines available If you find no solution you can obtain further information by contacting your CARDIOLINE supplier Before calling check you have the available documentation to hand and the product nearby It may also be necessary to supply the following information serial number and product reference number if available type of hardware available including any network hardware fitted operating system used for software products exact contents of any error messages displayed description of the operation being executed when the problem occurred description of any action taken to solve the problem SS um_ar1200view_cardioline_01_eng1 doc Rev 01 sr GZ 15 09 2005 Ref 36519130 Contents
17. 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 1 2 Information and recommendations relating to safe use The electrical system used by the device must be in accordance with the standard in force Always use the equipment 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 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 will not accept liability for any damage to the device or any other adverse effect 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 device tested by an Authorised Assistance Centre to verify its functional efficiency 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 pe
18. Y First make sure the patient is comfortable and relaxed and does not feel cold The individual should lie back on a suitably large couch with arms and hands extended along the sides of the body this will minimise the likelihood of the ECG trace being affected by muscle tremor Y Clean the skin thoroughly with alcohol or ether at the areas where the electrodes will be placed Y Connect each colour coded plug of the patient cable to the respective electrode observing the colour position matches 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 y Apply a small amount of electrocardiograph conductive gel to the area of the skin that will be in contact with the electrode spreading it 29 carefully and evenly this is not necessary when using disposable electrodes with built in gel v _ The following figure shows the standard positioning of the electrodes Standard positioning of the electrodes V1 on the 4th intercostal space right parasternal V2 on the 4th intercostal space left parasternal V3 on the 5th rib between V2 and V4 V4 on the 5th intercostal space left hemiclavicular V5 on the left anterior axillary same level as V4 V6 on the left mid axillary at the level of V4
19. amming masks Use number keys for Set units to be used for management of numerical patient data Weight and Height Two options are available cm Kg inch pound Mains filter To ensure the device operates correctly select the mains frequency in the area of use Two options are available 50 Hz 60 Hz Brightness and Contrast may be set according to the environmental Display conditions of use It is possible to modify bright and contrast pressing simultaneously Shift arrows from main menu A numerical ID 5 characters for the recorder being used can be Recorder ID entered Password A password maximum 8 characters can be entered that will be requested to access the archive if any to set change Use Profiles or to restore the factory configuration default If you do not wish to use the protection system leave the Password field blank Warning to change or disable a Password you need to know the current active Password It is therefore suggested that you carefully store the protection key used If you lose it contact the nearest Service Centre Tools The Tools menu allows the user to access system related information and enable the self test and setting functions of the device Options Actions available Displays the recorder identification data software version installed and language Print Configuration To print the general recorder configuration and use profiles enter
20. and diagnosis Interpretation processing and printing out of ECG interpretation In particular atrial diagnosis repolarisation disorders atrial blocks QRS T evaluation Parameters print complete ECG parameters table Templates printout of templates relative to the twelve leads The Copy key can be configured 1 Complete the last automatic recording is printed out in full 2 ECG only only ECG of last automatic recording is printed out 3 Analysis only only analysis of last automatic recording is printed out if available configuration ECG traces can be stored in different ways and memory status can be checked When operating in Paper Saving mode the saving function is always automatic Automatic traces are saved automatically when the scan is completed V with no action by the operator The operation is indicated on the display by Archive messages such as Saving and ECG saved management Upon request at the end of recording the patient s file is shown where the option Save amp Exit is available Press Pio proceed If the test does not have to be saved select Confirm amp Exit A copy of the test will still remain available until a new recording is made or the device is switched off None saving disabled 26 Det 4WY Manual files can be deleted using the delete function on the Look in ECG archive menu
21. ank Page intentionally left blank 55 56 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
22. aper by means of the high resolution thermal printer 3 3 R and 6 channels v sorting of the tests according to clock dater and alphanumeric keyboard to manage user and patient data Y storage of the most recent automatic recording and print of additional copies Y setting of up to 4 different user profiles to tailor device functions to differing requirements ar1200viewv can be updated with e memory option storage of up to 40 full ECG exams with no need to print out immediately on paper paper saving mode e ECG parameters option automatic ECG parameter measurement program e ECG signal interpretive option a useful and dependable diagnostic support e arrhythmia option a program enabling detection of arrhythmia events during continuous recording e HRV analysis option a program enabling detection of variations in heart rate e PC archive option for saving the exam to archive stored in a personal computer running CARDIOLINE software The data upload to the PC is made by use of the wireless IR interface no direct connection to the PC is required e PC ECG option for real time display of the twelve leads on your computer screen to allow management of patient medical records and archiving of exams in digital format using CARDIOLINE software The software has an optional module for automatic interpretation of the ECG signal e Emergency option allows to perform and eventuall
23. ate during any communication with the Authorised Support Centres 10 Rated voltage plate 11 Rechargeable battery compartment door 15 2 Installation and initial preparation This section describes the operations to be performed before using your new CARDIOLINE ari200view 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 thermal paper power supply control and management of the rechargeable internal battery switching on and off the menu set up 2 1 Selecting the installation site Your 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 equipments not in conformity with the aforementioned directives avoid the use of mobile phones near the electrocardiograph place the electrocardiograph as far as possible from electrical power lines and sources of static electricity The ECG signal can be disturbed if the electrocardiograph is placed near sources of high voltage or electricity lines avoid p
24. compartment located at the sliding bottom of the device and is protected against short circuits Warning before using the device it is necessary to go through a complete cycle of recharging of the battery Before connecting the electrocardiograph to the AC supply with the cable supplied make sure that the device supply voltage and the mains voltage are the same Warning the internal feeder of the device is classified under Class I Warning when the device is connected to the mains the battery is automatically recharged during use To gain maximum benefit from the characteristics of the dual power supply system follow the indications given below Recharging the battery The battery must be recharged when the power indicator symbol is partly empty Hh the reserve charge is lower than 30 Connect the electrocardiograph to the mains LED lit Complete battery recharging requires at least 18 hours For longer life the batteries should be allowed to run down and then be recharged completely at least every two months A complete recharge allows the recording of up to 300 complete ECGs automatic recording mode 3 channel print format 25 mm s speed Note recording with different print format the maximum number of tests recorded can change When the batteries are run down symbol Ch it is still possible to make an ECG recording by connecting the device to the AC supply Warning do not dispose of run down ba
25. damp environments observe the ambient conditions described in detail under the Technical specifications heading Periodically check the efficiency of all accessories and of the device itself Contact the Authorised Assistance Centre whenever the device seems to be operating irregularly To prolong the life of your device have it checked periodically by an Authorised Assistance Centre Warning The electrocardiograph can be used for intracardial applications Warning It is therefore necessary before activating the equipment to make sure of the connection to ground normally secured by the power supply cable If grounding of the main electrical service is not certain do not connect the device and use it powered only by the rechargeable internal battery Warning do not use the device in the presence of anaesthetics or volatile gases Warning 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 Operators must in any event read this manual carefully and familiarise themselves with the instrument before using it on a patient Warning the indications obtained using automatic interpreting programs or other diagnostic aids must be reviewed and countersigned by a qualified medical person Warning the device is provided with an IR interface for the transfer of data to other devices The IR interface must not be masked even
26. device use a cloth moistened 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 wash the leads box and the patient socket Note the device cannot be sterilised The electrodes can be sterilised with ethylene oxide 7 4 Battery replacement The battery pack should be replaced when the recorder is not used with the mains supply and the battery is low or run down therefore insufficient for operation The average life of a battery pack is about one year Warning Use only original batteries supplied with a protection device Warning Before removing from or introducing the batteries in the recorder make sure that the device is off and the power supply cable is disconnected from the mains Not doing so may cause electric shock to the patient or operator 1 Open the battery compartment 2 Annotate the battery pack connection polarities red black then remove the batteries from their housing by pulling the connector 3 Introduce the new batteries and reconnect the connector with the correct polarities red black 4 Close the battery compartment 49 5 Before using the recorder again read carefully the recharge instructions given in Battery recharge 6 Reset date and time in the appropr
27. e ECG trace or to incorrect positioning of the electrodes Automatic ECG interpretation M The automatic ECG interpreter is a function of the analysis program that can be used to obtain an evaluation of the trace at the end of each automatic recording he Start automatic at the end of the recording 36 he Stop automatic at the end of printing the report The message Analysis OK is displayed Warning The ECG Interpretation option assume that an ECG is taken on a rested person without pace maker Warning The correctness of the results furnished by the ECG Interpretation option also depends on the exact formulation of the physical data of the patient sex age that the user is kept to effect before the execution of the analysis according to the illustrated formalities in the User Manual The automatic interpretation program in case of missing patient data considers for the analysis a person of 35 years old gender male Warning if the device could not perform the test due to poor signal quality on the display the following error message is shown on the display Analysis na This situation may be due to excessive noise affecting the ECG trace or to incorrect positioning of the electrodes Note The ECG interpreter program is structured in four parts 1 processing and filtering of the electrocardiographic signal 2 identification of the waveform and positioning of the markers 3 calculation of the character
28. ed Default Configuration e near the ECG to factory configuration cancelling the settings There are two self test menus available User and Service See Maintenance chapter for details 28 4 Preparing for an ECG recording This section describes the preliminary operations required when recording an at rest electrocardiogram with the CARDIOLINE ari200view electrocardiograph In particular indications are given for connecting the patient cable preparing the patient applying the electrodes Also illustrated are the necessary procedures for choosing the correct recording parameters such as speed sensitivity and introduction of the filter 4 1 Connecting the patient cable Connect the terminal plug of the patient cable to the connector Te O identified with the symbol 9 positioned on the right side of the device Note to avoid breaking the patient cable remove it from the connector gripping it by the plug and without tugging Warning the device is protected internally against defibrillation discharges restoration of the signal is guaranteed as long as original electrodes are used To ensure conditions of safety are always maintained use only original accessories 4 2 Preparing the patient and applying the electrodes Careful preparation of the patient and correct positioning of the electrodes are fundamental in obtaining an ECG recording of high quality
29. ed format Any arrhythmic phenomena are highlighted on the trace V The signal is acquired and then reprocessed indicating the HRV analysis parameters and trends of the variation in heart rate ECG autotimer Bi are recorded automatically at user defined intervals in Settings The ECG archive M The menu allows the main archive management functions to be operated Options Actions available M Arrhythmia Monitor Displays the ECG list contained in the archive Scroll the list and select an exam patient The user can now 1 Archive the selected exam to a Personal Computer ArchPC 2 Print the selected example Print Delete the exam selected Delete Transfers and saves all stored exams to PC Print list Prints the list of exams currently in the memory Deletes all exams held in the memory A confirmation message is displayed Seach Searches a patient search key Name in the archive Settings The Settings menu allows different users to configure the functions of the electrocardiograph as best suits their individual working methods Configurable characteristics are grouped together in three menus Operation profiles General and Passwords 24 Operation profiles Up to four different Operation Profiles can be saved This facility enabled the recorder to be modified for different use requirements in just a few seconds Accessing the Operat
30. escribed above if the intention is to transfer the complete ECG archive A detailed management of the ECG transmission can be done by using the ECG archive menu e Position the electrocardiograph as indicated previously 39 he Select the ECG archive menu and proceed as appropriate For details of the options available see 8 ECG archive Warning in order to provide a correct transmission of data position the IR adapter from PC at a distance not greater than 50 cm Do not place any object between the two interfaces 5 4 Recording in Emergency mode M A Recording in Emergency mode is similar to an automatic recording a part from the patient data It allows to perform parameter calculation and analysis available ECG measurement option ECG interpretation option considering a person of 35 years old gender male to print a copy to store recording memory option and to transfer the exam to a PC PC archive option After selecting Emergency mode see Operation mode je lt a to start the recording If the signal has not yet been initialized the message Wait will be displayed e During the recording progress messages are displayed 1 Acquisition 2 Acquisition OK The patient can now be disconnected jie to interrupt printing stop If the signal has already been saved Acquisition OK it will still be possible to print a copy of the recording 5
31. esponding value is displayed The options available are 12 5 mm s 25 mm s and 50 mm s To select the printing speed O P je gt the corresponding value is displayed The options available are 5mm s 25 mm s and 50 mm s During printing the paper transport speed is indicated on the information line Sensitivity of recording on the display and on paper To select the sensitivity of recording on the display nil he al the corresponding value is displayed The options available are 5 mm mV 10 mm mV and 20 mm mvV To select the sensitivity of recording on printing alll jie o a the corresponding value is displayed The options available are 5 mm mv 10 mm mV and 20 mm mv During printing the recording sensitivity is indicated on the information line Note selecting O the sensitivity is set automatically by the device in a way that optimises the recording over the entire width of the paper In this case a sensitivity of 2 5 mm mV may be used This option is recommended for six 3 R lead printing To find out how automatic sensitivity is determined see Technical Specifications Recording filter If necessary it is possible to use filters capable of improving the legibility of 32 the signal without modifying its morphology Filter introduction affects both the displayed and the printed signal To ensure correct and accurate tests automatic interpretation of the trace is always performed only on the
32. essed reserve power between 15 and 30 After 10 secs have elapsed without any key being pressed reserve power lt 15 If the auto power off function is enabled the relative settings will be stored Auto power off is inhibited if a recording is in progress in ECG autotimer mode a recording is in progress in PC ECG mode a recording is in progress in HRV mode a recording is in progress in Arrhythmia mode during the self test routine during set up 19 3 Preparation for use the menu 3 1 How to access the menu he d to access the menu from the main screen Hain Menu Personalize Mode ECG Archive Settings Tools g ID DD to scroll through the menu items he executes the action associated with the symbol e displayed access the lower level menu select and confirm Y he d to scroll multiple selections If available symbol LX displayed he to return to the previous level 3 2 Structure of the menu The menu is organised in four sections Personalize mode ECG archive 1 20 Settings and Tools The following tree layout of the menu illustrates the different levels of exploration possible and the features that can be selected Details on the single items are given in subsequent headings gt Personalize mode o Emergency o Paper Saving M o PC cM o Arrhythmia Monitor M o HRV analysis M o ECG autotimer gt ECG a
33. g a recording M ECG memory archive management M Saving to Personal Computer archive M 5 4 Recording in Emergency mode M 5 5 Recording in ECG Autotimer mode 5 6 Recording in paper saving mode 5 7 Recording in PC ECG mode M 5 8 Recording in HRV Analysis mode M 5 9 Recording in Arrhythmia mode M 5 10 Defibrillation 6 Management and control of electrocardiograph functions 6 1 Disconnected electrodes potential defibrillation 6 2 Batteries low or in need of recharging 6 3 Print system control Out of paper 6 4 Status messages and error indication description and related event 6 5 Troubleshooting 7 Maintenance 7 1 Self test 7 2 Replacing the thermal paper 7 3 How to clean the device and the electrodes 34 34 35 35 36 36 37 38 38 39 40 40 41 41 42 43 44 45 45 45 45 46 47 48 48 49 49 7 4 Battery replacement 7 5 Display maintenance 7 6 Periodic checks Technical information 8 Technical specifications Basic accessories supplied 49 50 50 50 51 53 1 Introduction ar1200view is an electrocardiograph with dual power supply mains and rechargeable internal batteries whose basic configuration allows for the following functions Y ECG recording in automatic manual and timed mode v real time display of the ECG signal on the built in graphic display in 3 6 channel format Y reproduction of the ECG signal on several different formats of 120mm p
34. iate menu Warning If the battery pack connection polarities are not matched correctly severe damage can be caused to the recorder and the guarantee will be invalidated Warning Do not abandon the exhausted batteries in the environment Use only original batteries supplied by the manufacturer Note Removing the battery pack will not determine a loss of data 7 5 Display maintenance Y Keep the display dry and avoiding the formation of condensation If condensation forms the liquid crystals could be damaged v Use a soft cloth to clean the surface of the display Use of rough cloths could scratch the surface Y Do not use solvent based chemical products Warning in case the display panel breaks do not swallow the liquid released If this liquid comes into contact with skin or clothing wash immediately using abundant quantities of soapy water High pressure during use can cause fonts to be displayed abnormally Normal operations will be re established 7 6 Periodic checks To ensure correct and long lasting operation of the device it is necessary to have an Authorised Assistance Centre carry out the following checks Y paper drive speed calibration every year v cleaning of paper compartment paper presence sensor and writing system every year v integrity of cables and connectors every year by means of an ECG simulator Y general check of functional efficiency of the device and leakage cu
35. ignal has not yet been initialised the message Wait will be displayed he The patient data entry procedure now starts see Patient data entry Patient data are mandatory pe During the recording progress messages are displayed 1 Acquisition 2 Wait while the analysis is being performed the patient can now be disconnected 3 Save he When saving is complete copies of the recording can be printed or the recordings can be transferred to the PC using the Copy function or the ECG Archive menu 5 7 Recording in PC ECG mode M Associated with the CARDIOLINE software your ar1200view becomes a PC based acquisition system For details on the use of the application software consult the specific manual Having selected PC ECG mode see Operating mode je Position the electrocardiograph close to the infrared adapter 41 connected previously to the PC as illustrated in the following figure e lt a to start transmission The message PC ECG transmission is displayed During transmission the ECG leads are also displayed on the recorder display he to end transmission Warning to favour a correct transmission of data position the IR adapter for PC to a distance not greater than 50 cm Do not place any object between the two interfaces 5 8 Recording in HRV Analysis mode M Warning To obtain a correct recording in HRV
36. indicates scroll functions enabled Heart rate Selected speed of printing value on left and display value on right Selected sensitivity of printing value on left and display value on right Selected print format value on left and display format value on right 13 h Filter in place not in place indicator i Number of tests stored and space available M in Autotimer HRV Mano Arrhythmia salu it displays test timing l Time display m Battery status indicator n Operating information and error message area In Menu mode it indicates enabled keys and any additional options o In Autotimer HRV PC ECG Store in PC modes Arrhythmia displays a progress bar 3 Display control keyboard gt Cancel operation back to previous menu gt Ge E2 scroll menu and information In main screen scroll leads on display gt Access to Menu It scrolls multiple selections if any symbol C displayed 4 Alphanumeric keyboard for patient data management gt Characters that can be displayed in sequence are associated to each key gt Deletes texts before cursor gt Confirms operation Patient cable connector 6 Paper compartment door 7 Reset button gt used to re establish normal operating conditions in the event of an error that cannot be managed using the keyboard Mains line connector Identification plate Please refer to the information shown on this pl
37. ing time Internal battery 18 hours 100 Housing protection degree IP 20 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 hPa Dimensions 320 x 72 x 240 mm length x height x depth Weight 2150 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 EN 60601 2 25 A1 1999 Particular safety standards for electrocardiographs IEC 60601 2 51 Ed 1 2001 Particular standards on essential recording and analysis performance safety of single and multichannel electrocardiographs 52 Basic accessories supplied IEC Patient cable ref 63050025 6 suction cup electrodes ref 66030163 4 peripheral electrodes ref 660301105 1260 gr gel bottle ref 66020002 1 paper roll 120 mm x 20m ref 66010033 1 Z fold paper pack 120 x 100 mm x 30 metres ref 66010039 ECG ruler User s Manual Note may vary according to sale configuration selected upon purchase 53 54 Page intentionally left bl
38. ion Profiles menu the user can recall an existing profile Select Profile The list of saved Profiles is displayed Select the desired Profile the recorder settings are changed accordingly hr set a new profile Set Profile Anew Profile New can be created changed Change or deleted Delete C to select the desired option to confirm The parameters that can be associated to each profile are listed below Options Actions Description available A Profile Name 8 characters User Institution Name 30 characters Ward Dept Name 16 characters can be entered User Name and Ward Dept ID will be printed on all printed documents and sent to the PC when saved The profile name is used to retrieve the settings User Data However patient data can be entered and updated at any time The following data items are present in the file Patient ID Last Name First Name Date of Birth Sex Last Name 2 Blood Pressure Height Weight Type Medications Notes Ward Department Patient data management 0000000000000 Auto 3 R The signal representation mode can be selected when a 3 R format is selected 3 R Print Two options are available Report 1 simultaneous all 12 leads of the 3x4 part have the same time reference Management 2 sequential the 12 leads of the 3x4 part are represented in time sequence FP Rhythm Leads The reference lead can be set
39. istic parameters of the QRST complex 4 processing of the diagnosis and analysis of the rhythm The part of the program processing of the diagnosis and analysis of the rhythm provides the evaluation of the trace and specifically a identification of the parameters that deviate from standard these parameters are identified in the final document by an asterisk for example duration of P wave lengthening of PQ interval widening of QRS Furthermore the data related to the rhythm is analysed and evaluated and the related indications are given for example sinus arrhythmia sinus rhythm with extra ventricular systole with compensatory pause etc All diagnostic indications described are defined category B in accordance with American College of Cardiology conventions b analysis of repolarisation changes as internal or external and the degree of intensity as reflected by variations in the ST T segment These diagnostic indications are defined category c In the EKG program the category A diagnostic suggestions are obtained using a multivariate alternative classification that is a combination of statistical analysis and a ramified structure decisional technique By virtue of its characteristics and the reliability of the results provided the EKG program is in conformity with the requirements of IEC standards pertinent to programs for the automatic ECG trace evaluation Copy of an automatic ECG recording An ECG recorded in automatic
40. lacing the electrocardiograph close to other diagnostic or therapeutic equipment e g X ray machines ultrasound machines electrically operated beds etc that could be a source of excessive interference and ECG signal distortion if it is impossible to position the electrocardiograph at a distance from other electrical equipment switch the other equipment off while recording an ECG Also to avoid the effect of ambient conditions when recording ECG 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 record using the battery disconnecting the device from the mains power supply This avoids presence of mains power disturbance of the recorded ECG signal 2 2 Loading the thermal paper CARDIOLINE ari200view is able to reproduce the ECG signal both on thermal paper in rolls and on thermal paper in packs No particular configuration procedure is required To correctly load the two types of paper 16 If using paper in rolls a Open the paper compartment using a coin or a similar object remove the roll guide hub and the pack guide To avoid losing the guide place it in a safe place If replacing an empty roll retrieve the core before throwing away the empty roll b Insert the hub in a new paper roll 1 and house it in the paper compartment by positioning
41. lect the desired display format Iw gt the corresponding selection is displayed on screen The options are 3 6 When operating in Manual Mode the display and print formats coincide je g to scroll the leads on the display To select the desired print format jie f to select the desired format the corresponding choice is displayed on the screen The available formats are described below In Automatic mode the twelve ECG leads are printed by groups of three The total number of pages per block of leads depends on the settings Additional pages can be added if diagnosis is produced with the help of other means such as Interpretation In Manual mode three continuous leads In Automatic mode the twelve ECG leads are printed by groups of six The total number of pages per block of leads depends on the settings Additional pages are available if diagnosis aids e g Interpretation are used In Manual mode six continuous leads 31 In Automatic mode the twelve ECG leads are printed by groups 2 5 3 R sec per each lead 3x4 plus 10 sec for rhythm leads Additional pages are available if diagnosis aids e g Interpretation are used The selected format will be applied to all manual automatic and autotimed twelve lead recordings Speed of recording on the display and on paper To select the scrolling speed of the displayed signal e he a the corr
42. mode and computed ECG parameters if any can therefore be reproduced on paper any number of times 37 he to start printing a copy The message Copying is displayed he to interrupt printing stop If the memory does not contain valid data the message No data is displayed Note the trace is saved without filtering the signal irrespective of whether the filters are activated during the recording The parameters can therefore be modified before printing filters speed and sensitivity Warning If the Memory Option is not installed each new acquisition cancels the ECG trace saved previously If the Memory Option is installed the save procedure is related to the set up After switching off the unit enter the archive to obtain copy of the ECG recorded ECG memory saving a recording M At the end of the automatic recording the ECG may be saved in the memory The archive can contain up to 40 recordings for subsequent processing or transfer to PC Memory option he Start automatic or on demand at the end of a recording see Settings he If On Demand the patient file is displayed at the end of an automatic recording Two options are available Save amp Exit and Confirm amp Exit Select Save amp Exit to save the test or Confirm amp Exit if you do not wish to save the test In this case the test will remain available for copies until a new recording is made or
43. mory option and to transfer the ECG to a Computer PC archive option Having selected Automatic mode see Operating mode e TX to start the recording If the signal has not yet been initialised the message Wait will be displayed e The patient data entry procedure now starts see Patient data entry he During the recording progress messages are displayed 1 Acquisition 2 Acquisition OK The patient can now be disconnected jir to interrupt printing stop If the signal has already been saved Acquisition OK it will still be possible to print a copy of the recording Automatic calculation of ECG parameters M The program for automatic measurement of the ECG parameters allows a report of the principal parameters calculated to be obtained 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 message Analysis OK is displayed The principal items of information in the report are computed value of the following parameters heart rate rhythm type P QT QTc PQ QRS and QTr wave amplitudes frontal vectors axes summary table of ST values for to all twelve leads 7 templates of all twelve leads Ea Warning if the parameters cannot be computed the message Analysis nd is displayed This situation may be due to excessive noise affecting th
44. rchive M o View PC archive Print Delete o PC archive o Print list o Clear gt Settings o Operation Profile Select Profile Profile 1 Profile 2 Profile 3 Profile 4 Set Profile Change New User Data Profile Name User Institution Ward Dept Name 3 R Print Report e Auto 3 R o Simultaneous o Sequential e FP Rhythm Leads Lead Sequence e Standard e Cabrera Personalized Number of auto pages 1 page e 2 pages Configure Analysis ECG measurements o Summary 21 o ST amplitudes o Templates ECG interpretation o Summary Configure Copy o Rhythm o Interpretation o Measurements o Templates None Complete ECG Only Analysis Only M Archive Management M Save o Automatic o Request o None Deleting o Manual o Automatic Autotrx last ECG o Yes o No o Emergency only Analisi HRV M HRV analysis M Duration x Lead Autotimer No Intervals xxx Duration of intervals xxx Type of print o From memory o Realtime Print format o Auto o 3 leads Lead Selection o 6 leads Lead Selection Arrhythmia 22 RR Advance RR Delay Print Advance Print Delay Event Print ARR Lead Print delay e Yes No o General Date Time Measurement Units o Cm Kg o Inch Pound Mains filter 50 Hz 60 Hz Display Brightness Contrast Recorder ID o Password only numerical gt Tools o About o Configuration Print
45. rrents every 2 years Technical information et medical devices SpA undertakes when requested by qualified persons to furnish the list of components used in the device and the information necessary to repair the parts of the device considered serviceable 50 8 Technical specifications Mains power supply Internal supply class I 230 V 10 50 60Hz 115 V 10 50 60 Hz Maximum current 160 mA at 115 V 10 absorbed 80 mA at 230 V 10 Mains protection Fuse TO 5A Internal power supply 12V 1800 mAh NiMh rechargeable battery pack Internal power supply Pico fuse SHF SLO BLO T 5 A Littelfuse protection Applied part CF type Defibrillation protection In the device Input dynamic 300 mV 0 0 Hz 5 mV in pass band Input impedance gt 100 MQ on each electrode Common mode rejection gt 100 dB with balanced electrode impedance Frequency response 0 05 150 Hz 3db Time constant 3 35 Acquisition 11 bit 1000 samples s channel printing and filters 500 samples s channel in calculation and filters Resolution 5 uV bit Leads 12 leads in Standard Cabrera or Personalize sequence Signal memory 10 seconds for each lead in auto Recording display Manual 5 10 20 mm mV 5 sensitivity Automatic 2 5 5 10 20 mm mV 5 dependent on number of channels printed Writing system Thermal printer 8 dot mm Usable print height 108 mm Print channels 6 Print format 3 6 3 R Display channel 3 6 Paper transpo
46. rsons 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 Inthe event of other equipment being connected directly or indirectly to the patient check for the possible risks caused by the sum of the leakage currents on the body of the patient The device is protected against defibrillation discharges in accordance with IEC standard 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 device 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 when such devices are in use disconnect the patient from the electrocardiograph temporarily The device recognises 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 Avoid exposing the equipment to extreme temperatures excessive dust or dirt and very salty or
47. rt speed 5 mm s 10 25 50 mm s Screen scrolling speed 12 5 25 50 mm s Thermal paper In rolls 20 m long page 120x100 mm gridded Z fold pack 30 m long gridded 120x100 mm page Pacemaker recognition Recognises pulse in accordance with current IEC standards Filters Mains interference Modified linear phase digital notch filter 50 60 Hz may be switched on off Anti drift Digital high pass 0 5 Hz linear phase always enabled Serial interface Infrared Keyboard Membrane with functional and alphanumeric keyboard extended Display Single colour graphic 320x240 pixels 4 7 inches LCD Actual display area 100x75 mm 51 Backlit with cold cathode fluorescent light Interpretation program Parameter calculation optional ECG interpretation optional Arrhythmia Program optional HRV RR variability optional Type of use Continuous Operating modes Manual acquisition and printing in real time Automatic simultaneous acquisition Timed acquisition at user defined intervals Arrhythmia analyse in real time arrhythmic phenomenon s with recording in continuous PC ECG real time acquisition with display at PC HRV heart rate variability analysis Emergency acquisition in emergency Options Memories option ECG measurements option ECG interpretation option Arrhythmia option HRV option PC archive option PC ECG option Battery capacity Internal battery 100 min with 3 channel print Recharg
48. technician will investigate and eliminate the causes of the trouble The self test menu is accessed by selecting Tools gt Self test gt User Before running the self test procedure ensure that there is paper loaded e yy to select the type of test required he to start the test We Tests available o Display pixel scan The presence of blank areas signifies faulty operation of the display o Keyboard the position of the single keys is simulated in the display Pressing a given key the corresponding area of the display is energised A lack of response in any one area indicates that the relative key is faulty o Printer the writing system generates two triangular waves the character set in the memory and signals with different speeds and sensitivities Irregularities of the printing system are detectable in non continuous lines o Memory a message relating to the status of the memory is printed o About The following items of information are printed model identification serial number of the device details of software version and language code Warning do not run the service self test without a qualified technician in attendance 48 7 2 Replacing the thermal paper When the thermal paper is depleted the device stops and any attempt to start recording is inhibited see Print system control Out of paper 7 3 How to clean the device and the electrodes To clean the
49. the cursor he to confirm data he i to interrupt the data entry phase with no changes The data entered in the patient file are in sequence Patient ID Last Name First Name Date of birth Sex Last Name 2 Blood Pressure Height Weight Type Medications Notes Ward Dept Name The patient data are retained in memory until they are modified or the equipment is turned off Once entered the first name and last name are displayed on the main screen Warning new data will be saved only when the final item entered is confirmed 5 2 Recording in manual mode Having selected manual mode see Operating mode je E to start the recording If the signal has not yet been initialised the message Clamp is displayed he f to change the leads printed or displayed during recording The leads printed are those displayed on the screen he interrupt the recording stop Note during a manual recording it is possible to change the recording characteristics speed sensitivity filter Warning starting a manual recording cancels the last trace recorded in automatic mode 5 3 Recording in automatic mode An automatic recording allows the user to run available computation and analysis programs on the traces ECG Parameters ECG Interpretation 35 options to obtain a copy of the recording to save the recording Me
50. the pins in their specific guides 2 Make sure that the black mark on the paper is in the upper part of the roll c Position the paper by centring it between the two paper guides 3 Close the cover with the paper positioned between the rubber roller and the device case 4 If using paper in packs a Open the paper compartment using a coin or a similar object remove the pack guide and the roll guide hub To avoid losing the guide place it in a safe place b Prepare a new pack 1 and house it in the paper compartment Make sure that the red mark on the paper is on the upper left part of the pack Position the paper guide plate 2 onto the pack d Position the paper exactly in the centre between the two paper guides 3 Close the cover with the paper positioned between the rubber roller and the device case 4 Warning For reasons of safety the device must be used only with the paper compartment cover duly closed Warning use only original thermal paper or paper approved by the manufacturer The use of paper that does not respond to the manufacturer s specifications could jeopardise the correct operation of the device 2 3 Power supply control and management of the rechargeable battery Your electrocardiograph uses a dual power supply system AC supply mains and rechargeable NiMh battery The rechargeable battery which consists in a pack with 5 5 elements is housed in the special purpose
51. tteries in the environment Use only original batteries supplied by the manufacturer The average life of the batteries is about one year Warning the device must be connected only to mains equipped with earth connection executed in compliance with applicable regulations 2 4 How to switch on the electrocardiograph he aa for at least two seconds he The display turns on showing the Operation Profile screen When the booting procedure is completed the ECG signal and the settings selected are displayed on screen Now you can use the device Warning if the symbols CH and m are displayed internal power is insufficient and the battery must therefore be recharged by connecting the device to the mains see heading Power supply The battery will recharge even if the device is in use 18 2 5 How to switch off the electrocardiograph he jon The display turns off The settings for the last recording remain stored in the memory To see the effect of switching off on the last automatic recording see Copy an automatic ECG recording Warning switching off is not enabled as specified in 8 Auto power off In these cases first stop the device and then switch off Auto power off The procedure is enabled only after the current operation has been completed After 10 min have elapsed without any key being pressed reserve power gt 30 After 1 min has elapsed without any key being pr
52. vailable formats 3 6 Manual recording Recording mode selected in configuration phase Personalize mode In manual mode print and display format selections are consistent with each other In manual mode print and display format selections are consistent with each other 11 12 AC mains and muscle interference filter a al Select ECG scroll speed on display al Select paper scroll speed El Select ECG recording sensitivity on screen on fr Select ECG recording sensitivity on pa on El Enter patient data last recording o Store in PC A On display On Off Filter on 2v O Onpaper Available speeds 12 5 25 50 mm s Available speeds 5 25 50 mm s Available wavelengths 5 10 20 Available wavelengths 5 10 20 Automatic Displays patient data file 2 Display to display the ECG signal control operations patient data report data and settings t Y d BROWH 75 a JEMES oe HE LAE 7 Ss 25125 10 S MR 6 95 9 EP fo TA In normal operating mode a Patient data area displays Last Name first line and First Name second line ECG signal display area Each lead is preceded by its name Selected operating mode In Menu mode A Y 4
53. y transmit an ECG exam taken in emergency situation in completely automatic mode For more information on available options contact your selected dealer THANK YOU FOR BUYING CARDIOLINE 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 relevant CE0470 mark 1 1 How to read the manual In order to ensure the CARDIOLINE ari200view 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 that accompanies each individual appliance M This symbol allows you to identify the functions not provided on all models
Download Pdf Manuals
Related Search