Cardioline AR2100ADV - Frank`s Hospital Workshop
Contents
1. 13 If using paper in packs Open the paper compartment b Prepare a new pack and position it in the compartment Check that the red mark on the paper is on the upper left of the pack c Position the paper centring it between the two paper guides Close the cover positioning the paper between the rubber roller and the device case If using rolls of paper d Open the paper compartment and remove the roll 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 e Insert the core in a new roll of paper and place in the paper compartment fitting the pins into the guides provided Check that the black mark on the paper is on the upper part of the paper holder f Position the paper centring it between the two paper guides Close the cover positioning the paper between the rubber roller and the device case Caution 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 a c mains and a rechargeable lead battery The rechargeable battery is housed inside the device and is protected against short circuits Caution before using the device it is nec2. CARDIOLINE ar2100adv user manual C 0470 english This User Manual has been prepared with the objective of giving the user all the information necessary to make the best use of the CARDIOLINE ar2100adv 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 v 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 KKK K KS um_ar2100adv_cardioline_02_eng1 Rev 02 sr GZ 20 03 2007 Ref 36519098 Contents
3. 1 Introduction 1 1 How to read the manual 1 2 Information and recommendations relating to safe use 1 3 The electrocardiograph Front view Side view Parts symbols and controls 2 Installation and initial preparation 2 1 Selecting the installation site 2 2 Loading the thermal paper 2 3 Power supply control and management of the rechargeable battery Recharging the battery 2 4 How to switch on the electrocardiograph 2 5 How to switch off the electrocardiograph Auto power off 3 Preparation for use the menu 3 1 How to access the menu 3 2 Structure of the menu 3 3 Menu activated operation and personalization of the electrocardiograph Personalise mode M The ECG archive M Settings Tools 4 Preparing for an ECG recording 4 1 Connecting the patient cable 4 2 Preparing the patient and applying the electrodes 4 3 Select recording characteristics operating mode print format sensitivity filters Operating mode Print format Speed of recording on paper Sensitivity of recording on paper Recording filters 5 Recording of a rest ECG O OO N OO U 10 13 13 13 14 14 15 15 16 17 17 17 20 20 21 21 24 25 25 25 speed 26 26 27 28 28 28 30 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 saving a rec
4. 60 Hz Display Brightness Contrast Tools o About o Print Profile o Default Configuration o Self test User Display 19 Keyboard Printer Memory About Service Not Available 3 3 Menu activated operation and personalization of the electrocardiograph Listed below are the operating and configuration details associated with the single items of the menu To operate the menu refer to the heading How to access the menu Personalise 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 selected mode is indicated in the main page of the display at the top left oo 4 Options Actions available 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 p f monitored through messages in the display the recording can be aper saving 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 it is possible to 7 perform all the ECG recording operations The ECG signal is acquired in continuous mode and then printed in compressed 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
5. and the features that can be selected Details on the single items are given in subsequent headings gt Personalised mode o Paper Saving M o PCECG M o Arrhythmia Monitor M o HRV analysis M o ECG autotimer o Arrhythmia Monitor M 17 gt ECG archive M o o o o View PC archive Print Delete PC archive Print list Clear gt Settings o 18 Operation Profile Patient data management All None Patient ID First Name Last Name 1 Last Name 2 Date of Birth Sex Height Weight Type Blood Pressure Medications Notes Ward Dept Lead Sequence Standard Cabrera Auto FP Simultaneous Sequential FP Rhythm Leads Change Lead Selection rss Y ECG parameters e Summary e ST amplitudes e Templates ECG interpretation e Summary e Rhythm e Interpretation Parameters e Templates None Configure Copy Complete ECG Only Analysis Only M Archive EET E Save Automatic e On demand None Deleting Manual Automatic y Y z Duration x Lead Autotimer No Intervals 7 Duration of intervals xxx Print format 12 leads e 3 leads Lead Selection e 6 leads Lead Selection Arrhythmia mode RR Advance RR Delay Print Advance Print Delay Arrhythmia Monitor o General User Name Device ID Ward Dept Name Date Time Units o Cm kg o Inch Pound Page Format Mains filter 50 Hz
6. 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 Personalised Automatic mode 3x1 3x2 6x1 6x2 12 Full Page 1 Full Page 3 Manual mode 3 6 12 Manual recording Recording mode selected in configuration phase Personalised mode filter on paper speed 25 mm s paper speed 50 mm s select paper speed paper speed 5 mm s automatic sensitivity the device optimises the ratio between n channels and available space sensitivity 5 mm mV select recording sensitivity sensitivity 10 mm mV sensitivity 20 mm mV copy last recording Display to manage operating functions and patient data In normal operating mode line 1 information on recording parameters selected gt line 2 operating information and error messages gt line 3 battery charge status heart rate menu gt AV indicate the presence of additional menu options and information gt cancel operation delete text return to previous menu gt D scroll menus and information gt Menu access and selection Execute action highlighted on lower right of display e g 8M QWERTY alphanumeric keyboard for patient data management 11 gt displays symbol map and special
7. 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 OLL1 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 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 A 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 Follow the indications given in the heading Installation and initial preparation 39 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 inhibited automatically and the messages Out
8. end of printing the report The message Analysis OK is displayed Warning The automatic interpretation program in case of missing patient data considers for the analysis a person of 35 years old gender male Warning the computerised analysis must always be validated by the medical specialist responsible for the ECG examination Warning if the device cannot perform the analysis due to poor signal quality the following error message appears 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 32 1 processing and filtering of the electrocardiographic signal 2 identification of the waveform and positioning of the markers 3 calculation of the characteristic 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 syst
9. heart rate ECGs are recorded automatically at user defined intervals in Settings menu M Arrhythmia Monitor ECG autotimer 20 The ECG archive M The menu allows the main archive management functions to be operated Options Actions available 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 3 Delete the exam selected Delete Settings The Settings menu allows different users to configure the functions of the electrocardiograph as best suits their individual working methods Configurable properties are grouped together into two menus Operation Profile and General Operation Profile Options Actions available The method of managing patient data can be selected by the user The selected data will be requested at the start of each recording Select All None to cancel the request or enable the complete list o All None to quickly select or de select all available data Patient ID Name Last Name Last Name 2 Date of Birth Sex Height Weight Type Blood Pressure Medications Notes Ward Dept to modify the reference entered in the settings phase for the current ECG only Patient data management o o o o o o o o o o o o o 21 Lead Sequence Auto FP FP Rhythm Lead
10. not affected by disturbances originating from the a c mains power supply see Initial preparation 4 3 Select recording characteristics operating mode print format speed sensitivity filters Operating mode The available recording modes Operating mode depend on the active configuration of the electrocardiograph MN CA he ES to select the desired mode the corresponding choice is displayed on the screen The options available are Automatic Manual Personalised To change Personalised mode see Settings During printing the active mode is printed on the information line of the printout 26 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 Personalised See Personalised mode for details Print format Several print formats are available according to the operating mode selected he to select the desired format the corresponding choice is displayed on the screen The available formats are as follows In Manual mode three leads per page continuously Format Type In Manual mode six leads per page continuously In Automatic mode the twelve ECG leads are printed on a single Total page pages per ECG 1 Additional pages if diagn
11. 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 In the 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 u
12. 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 For more information on available options contact your selected dealer 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 relevant CE0470 mark 1 1 How to read the manual In order to ensure the CARDIOLINE ar2100adv 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 f
13. ains with earth connection realised following the current regulations 2 4 How to switch on the electrocardiograph po for at least two seconds he The display lights up for at least two seconds The display lights up Warning if the symbols CH and Zh 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 2 5 How to switch off the electrocardiograph he 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 1 during the transmission of an ECG to a PC 2 during the self test routine 3 if set up mode is active In these cases first stop the device and then switch off 15 Auto power off To conserve 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 has elapsed without any key being pressed reserve power gt 30 After 1 min has elapsed without any key being pressed reserve power between 15 and 30 EF Afte
14. ait while the analysis is being performed 36 the patient can now be disconnected 3 Save pr Once the ECG has been stored it can be printed or transferred to a PC from the ECG archive function 5 7 Recording in HRV Analysis mode M Warning To obtain a correct recording in HRV 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 he lt To start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed Ww If predict the patient data entry procedure now starts see Patient data entry pr The display show
15. an be entered The name of the Ward Dept performing the recording can be entered Ward Dept name The name entered can be changed before a recording enabling the Ward Dept request in the patient data settings Date Time Accessing the date time programming masks Use number keys for settings Units Set units to be used for management of numerical patient data Weight and Height Page format Set reference page format UNI A4 or Letter fe 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 Contract may be set according to the environmental Display e conditions of use Tools The Tools menu allows the user to access system related information and activate the self test and setting functions of the device Options Actions available Displays the version of software program installed Print Profile To print out the operation profile set Default Configuration le htc the ECG to factory configuration cancelling the settings There are two self test menus available User and Service Do not run the service self test without a qualified technician in attendance For details see Maintenance 24 4 Preparing for an ECG recording This section describes the preliminary operations required when recording an at rest electrocardiogram with the CARDIOLINE ar2100adv electrocardiograph In part
16. arning 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 acknowledge liability for the safety reliability and functional efficiency of the device only if o modifications and repairs are performed by the manufacturer or by an Authorised Assistance Centre o the a c mains power supply of the building responds to current regulations o the device is operated according to user instructions o any accessories in use 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 with the logic of its operation Front view ES o Side view GURSEUROKRACURULEN 42 1 Bu Le Parts symbols and controls 1 Keyboard Function ke select start operating mode interrupt current operation stop e o select operating mode select print format x a c mains and muscle interference filter 10 Messages amp Symbols displayed Associated LED LED on device connected to mains power internal battery charging full symbol battery charged
17. characters B to select to copy symbol into text gt Q delete text gt confirm CF type patient cable connector protected against defibrillation as indicated by the w symbol Paper compartment door 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 Equipotential earth connection functional IR infrared interface 2 Installation and initial preparation This section describes the operations to be performed before using your new CARDIOLINE ar2100adv 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 dire
18. ctives 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 placing 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 ar2i00adv is able to reproduce the ECG signal both on thermal paper in Z fold packs Thermal paper in rolls with can also be used It s necessary to insert the page format Letter refers to the following 8 for the configuration menu To correctly load the different types of paper
19. d the time of recording format xx yy min he e to start a recording manually within an interval 35 he my to interrupt stop 5 5 Recording in PC ECG mode M Your ar2100adv 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 he Position the electrocardiograph relative to the infrared adapter connected previously to the PC as illustrated in the following figure A PERR Y A Ww KEN to start transmission The message PC ECG transmission is displayed he EJ to end transmission 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 5 6 Paper Saving mode M 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 e to start the recording If the signal has not yet been initialised the message Wait will be displayed If predict the patient data entry procedure now starts see Patient data entry Ww During the recording progress messages are displayed 1 Acquisition 2 W
20. e chosen the option View 30 hw my to terminate the data entry step the recording is cancelled 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 ee Ww to start the recording If the signal has not yet been initialised the A symbol will be displayed hr If predict the patient data entry procedure now starts see Patient data entry lt he lt to change the leads printed during recording The names of the active leads are indicated in the display O po Note during a manual recording it is possible to change the recording characteristics speed sensitivity filters 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 options to obtain a copy of the recording to save the recording Memory option and to transfer the ECG to a Computer PC archive option to interrupt the recording stop Having selected Automatic mode see Operating mode he e to start the recording If the signal has not yet been initialised the message Wait will be displayed The patient data entry procedure now starts see Patient da
21. e 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 25 v Apply a small amount of electrocardiograph conductive gel to the area of the skin that will be in contact with the electrode spreading it 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 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
22. ecording on paper O he Ey to select the speed the corresponding value appears in the display 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 paper he Ey to select the sensitivity the corresponding value appears in the display 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 multi channel printing To find out how automatic sensitivity is determined see Technical Specifications 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 om NN he to activate the filters the corresponding symbol appears in 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 perman
23. ently activated During printing the activated filters are indicated on the information line 28 Warning the filters of your ECG are 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 29 5 Recording of a rest ECG 5 1 Patient data entry At the beginning of each recording in case you have choose to insert patient data except in the case of PC ECG mode the patient data management pages are displayed Phase 1 select type of patient he to clear data relative to the previous recording and begin a new entry hr amp to display the View option he to scroll through existing data and confirm je to confirm without modification Phase 2 enter data The display prompts in sequence for Patient ID First name Last name 1 Last name 2 Date of birth Sex Height Weight Type Blood Pressure Medications Notes Ward Dept pe 68 to enter data he Q to delete the character highlighted by the cursor Ww to change the position of the cursor and select the Sex of the patient i to start the recording without patient data if you have chosen the option new patient or with the previous data if you hav
24. es 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
25. essary to go through a complete cycle of recharging of the battery Before connecting the electrocardiograph to the a c supply with the cable supplied check that the mains voltage is the right voltage for the device Caution when the device is connected to the mains the 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 battery The battery must be recharged when the power indicator symbol is part 14 empty Zh the reserve charge is lower than 30 Connect the electrocardiograph to the mains Led lit Complete recharging of the battery requires at least 24 hours For longer life the battery should be allowed to run down and recharged completely at least every two months A complete recharge allows the recording of up to 220 complete ECGs automatic recording mode 6 channel print format speed 25 mm s complete with analysis two pages If the battery should be completely discharged symbol Ch it is still possible to make an ECG recording by connecting the device to the a c mains supply The average life of the battery is more than 300 complete discharge recharge cycles Warning do not dispose of a spent battery as ordinary refuse or litter If the battery appears to need replacing consult an Authorised Assistance Centre Warning the device must be connected only to m
26. icular 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 activation of filters 4 1 Connecting the patient cable Connect the terminal plug of the patient cable to the connector Be oe identified with the symbol ig 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 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 cabl
27. irmware configuration chart that accompanies each individual appliance M 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 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 ar2100adv 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 c
28. isition without action by operator The operation is indicated on the display by the following messages Saving and ECG saved V On Demand when recording is complete Archive management confirm save request displayed Save ECG Press OK to continue None saving disabled gt Delete Manual files can be deleted using the delete function on the Look in ECG archive menu Automatic archive files are deleted automatically after successful transmission to a PC with the ArchPC function V The following can be set duration of the test 1 to 5 minutes and HRV analysis reference lead for analysis The following can be set number of recordings intervals duration of intervals i e time between recordings 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 ECG Autotimer Arrhythmia 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 23 General Options Actions available The user ID data can also be entered and reproduced on all printed User Name q documents Space available 30 characters An item identifying the device being used c
29. ncels the ECG trace saved previously 33 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 pr Start automatic or on demand at the end of a recording see Settings Warning The message Memory full is displayed when the memory space is closed to be 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 Having selected ECG Archive he to select the menu 1 View 2 PC Archive 3 Print List 4 Empty he to confirm the menu 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 n
30. ng protection IP 20 category ee Ambient conditions operation transport and storage Ambient temperature from 10 C to 40 C Relative humidity from 25 to 95 without condensation Atmospheric pressure from 700hPa to 1060 hPa Ambient temperature from 10 C to 40 C Relative humidity from 10 to 95 without condensation Atmospheric pressure from 500 to 1060 hPa Dimensions 325 x 80 x 345 mm length x height x depth Weight 4800 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 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 ref 63050025 6 suction cup electrodes ref 66030163 4 peripheral electrodes ref 63030105 Bottle gel ref 66020002 1 pack Z fold paper 210mm x 150mm x 30 metres ref 66010027 not available 1 pack Z fold paper 210mm x 140mm ref 66010045 ECG ruler User manual 45 46 Page intentionally left blank Page intentionally left blank 47 48 CARDIOLINE Marketing amp Sal
31. nterpretation o Summary represents the minimum report and cannot be de selected The following are reported date and time of recording patient data note field ECG parameters calculated frontal vector indication of normality Rhythm Analysis print rhythm strip 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 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 The PC Archive function enables the trace recorded and stored automatically to be transferred to a PC using CARDIOLINE software The functions of the copy key change according to the choice made Mo arhive 1 Copy to PC when the copy key is pressed the past automatic recording is transferred to the PC 2 Hard copy pressing the copy key the last recording is printed out on paper The way in which ECG traces are saved can be set and the memory status checked gt Save Automatic trace saved automatically after acqu
32. 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 na Automatic ECG analysis cannot be performed due to excessive signal noise No data Impossible to obtain copy of the last recording A Critical electrodes Waiting for signal to be centred before printing can start 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 W Batteries low C p Batteries completely discharged 40 6 5 Troubleshooting The following table summarises certain problems that may occur and the relative causes Problem Cause Use of electrodes other than originals Use of electrodes in saturation Insufficient electrode skin contact Electrode surface dirty Patient moving Isoelectric line drift Interference from a c 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 n
33. ole 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 mode and computed ECG parameters if any are automatically saved and can therefore be reproduced on paper any number of times pe to start printing a copy The message Copying is displayed he 3 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 ca
34. ommands presented in the manual 6 Further information and clarifications can be requested directly from CARDIOLINE Supporto Prodotto 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
35. ording M ECG memory archive management M Saving to Personal Computer archive M 5 4 Recording in ECG Autotimer mode 5 5 Recording in PC ECG mode M 5 6 Paper Saving mode M 5 7 Recording in HRV Analysis mode M 5 8 Recording in Arrhythmia mode M 5 9 Defibrillation 6 Management and control of electrocardiograph functionalities 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 7 4 Periodic checks 8 Technical specifications Basic accessories supplied 30 31 31 32 32 33 34 34 34 35 36 36 37 37 38 39 39 40 40 41 42 42 43 43 43 44 45 1 Introduction ar2100adv combines optimised performance in multichannel ECG recording with all the features of reliability modularity versatility and upgradeability that characterise the latest generation of CARDIOLINE electrocardiographs ar2100adv is an electrocardiograph with dual power supply mains and rechargeable internal batteries which in the basic configuration will Y record an ECG exam in automatic manual and timed mode v reproduces the ECG signal on 210 mm paper in various formats thanks to high resolution thermal
36. osis aids e g Interpretation are available In Manual mode twelve leads per page continuously In Automatic mode the twelve ECG leads are printed out in groups of three each page presents two groups Total no of pages per ECG 2 Additional pages if diagnosis aids e g Interpretation are available In Automatic mode the twelve ECG leads are printed out in groups of three each page presents two groups Total no of pages per ECG 4 Additional pages if diagnosis aids e g Interpretation are available wm N In Automatic mode the twelve ECG leads are printed out in groups of six per page and each page presents two groups Total no of pages per ECG 1 Additional pages if diagnosis aids e g Interpretation are available In Automatic mode the twelve ECG leads are printed in groups of six on a single page Total no of pages per ECG 2 Additional pages if diagnosis aids e g Interpretation are available 27 In Automatic mode the twelve ECG leads are printed on a single page 2 5 secs for each lead 3x4 plus 10 secs for the rhythm leads up to 3 selected by the user in FP3 The upper part of the page Full Page 1 3x4 R Full Page 3 3x4 R reports the diagnosis summary if available Total no pages 1 Additional pages if extended diagnosis aids e g Interpretation available The selected format will be applied to all manual automatic and autotimed twelve lead recordings Speed of r
37. ot installed he Position the electrocardiograph relative to the infrared adapter connected previously to the PC as illustrated in the following figure 34 sae d he plus to start the transfer If the Memory Option is installed The user can either proceed as described 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 he Position the electrocardiograph as indicated previously hw Select the ECG archive menu and proceed as appropriate For details of the options available see ECG archive 5 4 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 he lt 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 If predict the patient data entry procedure now starts see Patient data entry Ww The programmed recordings are in real time The printouts shown information alongside the date time field relating to the number of the interval an
38. ot relaxed Peripheral electrodes adhering too tightl 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 Recording interrupted before 10 seconds have elapsed Abnormal signal Defective patient cable Defective electrodes 41 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 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 je he to start the test he E to select the type of test required Tests available o Display pixel scan The presence of blank areas signifies faulty operation of the display 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 Printer the writing system gene
39. printer 3 6x1 6x2 Full Page 1 3x4 R for 1 page Full Page 3 3x4 3R for 1 page and 12 channels Y store the most recent recording in automatic mode and print additional copies Thanks to the flexibility of the software used and to the infrared interface the ar2100adv 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 the 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 ar2100adv can be equipped with memory option storage of up to 40 full ECG exams with no need to print out immediately on paper paper saving mode ECG parameters option automatic ECG parameter measurement program ECG signal interpretive option a useful and dependable diagnostic support provided by the program arrhythmia option a program enabling detection of arrhythmia events during continuous recording 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
40. r 10 sec have elapsed without any key being pressed reserve power lt 15 Ch If the auto power off function is activated last ECG recorded if any and the relative settings will be held in the memory 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 the device is connected to the mains 16 3 Preparation for use the menu Navigating within the menu of your ar2100adv there are options for intuitive personalization of the operating modes using the dedicated display keys To ensure your electrocardiograph can be operated taking advantage of its simplicity and versatility of use to the maximum it is advisable to select the preferred set up before the first recording is made 3 1 How to access the menu From the main page Ww to display the menu pe amp to scroll through the menu items Ww to access the lower level menu or make a selection Execute action highlighted on lower right of display e g 9 hr to return to the previous level 3 2 Structure of the menu The menu is organised in four sections Personalised mode ECG archive Settings and Tools The following tree layout of the menu illustrates the different levels of exploration possible
41. rates 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 Memory a message relating to the status of the memory is printed About The following items of information are printed model identification serial number of the device details of software version and language code Warning attendance 42 do not run the service self test without a qualified technician in 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 To replace the paper proceed as indicated in the heading Installation and initial preparation 7 3 How to clean the device and the electrodes To clean the 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 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 v paper drive
42. s M Analysis configuration Configure Copy 22 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 Two options are available 1 Standard 2 Cabrera The way the signal is represented may also be selected when a Full Page format is selected Two options are available 1 simultaneous all 12 leads of the 3x4 part have the same time reference 2 sequential the 12 leads of the 3x4 part are represented in time sequence The reference leads can be set for rhythm in FP formats 3x4 R and 3x4 3R 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 gt ECG Parameters o 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 QRS and QTr wave amplitudes frontal vectors axes ST Parameters printout of table of ST depression values on the twelve leads o Templates printout of templates relative to the twelve leads gt ECG I
43. s 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 hr EJ to interrupt stop No report is printed and the recorded data are cancelled hw to print copy of the report at the end of the test 5 8 Recording in Arrhythmia mode 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 37 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 To start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed hr The pa
44. se at the time of drafting this manual Avoid exposing the equipment to extreme temperatures excessive dust or dirt and very salty or 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 W
45. speed calibration every year Y 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 currents every 2 years Technical information Technical information et medical devices SpA undertakes when requested by qualified persons to furnish the circuit diagrams and the list of components used in the device and the information necessary to repair the parts of the device considered serviceable 43 8 Technical specifications A c mains power supply A C mains with internal power supply 230 V 10 50 60Hz 115 V 10 50 60 Hz Maximum current 0 5 mA at 115 V 10 absorbed 0 25 mA at 230 V 10 Mains protection Fuse T 0 5 A Internal power source 12 V 2Ah rechargeable lead battery Internal power supply Pico fuse SHF SLO BLO T 5 A Littelfuse protection Applied part CF type Defibrillation protection Internal Input dynamic 300 mV 0 Hz 10 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 Time constant 3 3 s Acquisition 12 bit 1000 samples s channel printing and filters 500 samples s channel in calculation and filters Resolution 5 uV bit Leads 12 Standard or Cabrera leads Signal memory 10 seconds for each lead in automatic mode Recording sensiti
46. ta entry he During the recording progress messages are displayed 1 Acquisition 2 Acquisition OK The patient can now be disconnected 31 pe my 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 PR QRS and QTr wave amplitudes frontal vectors axes summary table of ST amplitudes relative to all twelve leads 7 templates of all twelve leads A Warning if the parameters cannot be computed the message Analysis nd is displayed This situation may be due to excessive noise affecting the 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 at the end of each automatic recording Ww Start automatic at the end of the recording he Stop automatic at the
47. tient data entry procedure now starts if predict see Patient data entry hr Pressing again the key after choosing new patient the recording start without entry the data patient h 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 in any case every 5 minutes if the test is longer than it O Ww Ka to interrupt stop 5 9 Defibrillation If defibrillation occurs the 4 symbol is displayed Within 10 seconds of the discharge the signal is automatically restored if a printout of the signal was active in manual mode Remember always to avoid direct contact between the electrodes of the defibrillator and those of the electrocardiograph The original approved electrodes supplied with the electrocardiograph have been designed so as to minimise the risk in case of accidental contact 38 6 Management and control of electrocardiograph functionalities 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 A 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
48. vity 5 10 20 mm mV Monitor Backlit graphic display 120x32 pixels 61x16 mm 2 5 inches Writing system Thermal printer 8 dot mm Usable print height 210 mm Print channels 12 Print format Automatic mode 3 6x1 6x2 Full Page 3x4 R x1 12x1 Manual mode 3 6 12 Paper transport speed 5 mm s 10 5 25 50 mm s Thermal paper in rolls length 17 m page 210x280 gridded Z fold pack length 28 m page 210x140 mm gridded Z fold pack length 60 m page 210x280 mm gridded Pacemaker recognition Recognises pulse in accordance with current IEC standards 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 and alphanumeric keyboard extended 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 44 Timed acquisition at user defined intervals Arrhythmia arrhythmic event recognition optional PC ECG real time acquisition with display at PC HRV heart rate variability analysis Paper Saving Automatic acquisition and archiving without printing Battery capacity Internal battery 1hour with printing in 6 channel mode Recharging time Internal battery 24 hours 100 Housi
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