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Cardioline AR2100viewbt - User manual

1. Red C1 Vi White Yellow C2 V2 White Green C3 V3 White Brown C4 V4 White Black C5 V5 White Violet C6 V6 amp 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 amp 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 6 L V4 on the 5th intercostal space left oo LA hemiclavicular v g 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 RL N E LL 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 a c mains power supply see Initial preparation CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um
2. 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 Recording in manual mode Having selected manual mode see Operating mode lt a to start the recording If the signal has not yet been initialised the message Clamp is displayed to change the leads printed or displayed during recording The leads printed are those displayed on the screen to interrupt the recording stop 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 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 Having selected Automatic mode see Operating mode to start the recording If the signal has not yet been initialised the message Wait will be displayed amp During the recording progress messages are displayed 1 Acquisition 2 Ac
3. Reset button L gt used to re establish normal operating conditions in the event of an error that cannot be managed using the keyboard 8 Mains line connector 9 Equipotential earth connection functional 10 IR infrared interface CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 15 56 CARDIOLINE ar2100viewbt Installation and initial preparation This section describes the operations to be performed before using your new CARDIOLINE ar2100viewbt 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 nu electrocardiograph for use such as loading the thermal paper power supply control and Hf H Tf fL un management of the rechargeable internal battery switching on and off the menu set up 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 amp avoid the use of
4. amp summary table of ST values relative to all twelve leads El amp templates of all twelve leads el 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 amp Start automatic at the end of the recording amp Stop automatic at the end of printing the report The message Analysis OK is displayed amp When analysis and printing is complete if the Editor function is enabled the patient file is displayed see Editing a report It is therefore possible to change and add to the information obtained in the Summary section el 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 39 56 CARDIOLINE ar2100viewbt Warning if the device cannot perform the analysis due to poor signal quality the following error message appears on the displa
5. 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 8 56 CARDIOLINE ar2100viewbt E 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
6. Manual mode homogeneous display format formats available S 3 3x2 6 6x2 In manual mode print and display CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 12 56 Automatic mode formats available en 3 az Sr oir E In manual mode print and display select print EU Page dy EU format selections lt Page 3 ormat Manual mode formats available 3 6 12 a c mains and On Display On Off crer on muscle Su paper interference filter Speeds available 5 25 Select paper 50 mm s scroll speed homogeneous recording sensitivity on Wavelengths available Select ECG recording gt 10 20 sensitivity on Automatic paper CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 13 56 CARDIOLINE ar2100viewbt 2 Enter patient Displays patient data file Copy last recording Display to display the ECG signal management of functioning operations patient data report data and settings hk JOHN DH RE In normal operating mode sermancov Patient data area display Last and First Names ECG signal display area Each lead is preceded by its name Selected operating mode In Menu mode 4 W gt indicates scroll functions active Heart rate Selected speed of printing val
7. SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 44 56 CARDIOLINE ar2 100viewbt 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 lt a g To start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed 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 Ly to scroll the leads displayed during the test based on the electrodes connected to interrupt stop No report is printed and the recorded data are cancelled to print copy of the report at the end of the test 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 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 r
8. amp ARR Leads select lead full disclosure report It could be possible enable disable 10 s print delay referred Print Delay to a real time event General Options Actions Description available Date Time Accessing the date time programming masks Use number keys for settings Set units to be used for management of numerical patient Units data Weight and Height Two options are available Standard cm Kg US Inch Pound Page Format Set reference page format UNI A4 or Letter To ensure the device operates correctly select the mains a c mains filter frequency in the area of use Two options are available 50 Hz 60 Hz Brightness and Contrast may be set according to the environmental conditions of use A numerical id 5 characters for the recorder being used can Recorder ID be entered Password A password maximum 8 characters can be entered to be requested when reports are being prepared Editor function to access the archive if present 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 of 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 Display Tools The Tools menu allows the user to acce
9. 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 The manufacturer will acknowledge liability for the safety reliability and functional efficiency of the device only if 1 modifications and repairs are performed by the manufacturer or by an Authorised Assistance Centre 2 the a c mains power supply of the building responds to current regulations 3 the device is operated according to user instructions 4 any accessories in use are those approved by the manufacturer Instructions for the Bluetooth transmission The device is conforming to the requisite required by the Directive R amp TTE on the Radio Equipment and Telecommunications Terminal Equipment Nevertheless with the purpose to protect the device from other devices NOT conform to the normative aforesaid we recommend to put the device the most distant possible from other devices that use the transmission Bluetooth The electrocardiograph In order to simplify t
10. mobile phones near the electrocardiograph amp 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 amp 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 amp 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 amp 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 Loading the thermal paper CARDIOLINE ar2100viewbt is able to reproduce the ECG signal both on thermal paper in Z fold packs Thermal paper in rolls can also be used It s necessary to plan the format page as CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 1
11. the cause of the interference and not only the visible effect on the trace see Troubleshooting Initial preparation CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 35 56 CARDIOLINE ar2100viewbt Recording of a rest ECG Patient data entry Ar E U to display the patient file at any time FATIEHT DATA Fatient ID 123 Surn ne gt JOHH Home 5 OHERE Date of Birth 1270371968 Eden sey Bex l Male Surnane 2 Blood Pressure 88 128 EmmHal Heisht 175 cma Heisht 73 ka Type i Caucasian Hedicanents HOHE Hote SMOKER A 4 io Contr 1 rn zes as za Inside the patient file amp display the New option Confirming the data presents are cancelled D Qo to move around inside the file and display the options associated with the Type nr to enter data E to clear the character highlighted by the cursor CD to confirm data to interrupt the data entry phase with no changes CARDIOLINE is an et medical devices SpA brand User Manual um_ar2100viewbt_03_eng1 doc Rel 1 1 Ed 1 1 36 56 www cardioline biz CARDIOLINE ar2100viewbt 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
12. transfer the exam to a PC PC archive option After selecting Emergency mode see Operation mode lt a to start the recording If the signal has not yet been initialized the message Wait Will be displayed The procedure Patient data entry is omitted During the recording progress messages are displayed 1 Acquisition 2 Acquisition OK The patient can now be disconnected g 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 42 56 CARDIOLINE ar2 100viewbt 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 lt a amp to start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed amp The programmed recordings are in real time The printouts shown information alongside the date time field relating to the number of the interval and
13. 1 1 www cardioline biz Basic accessories supplied Patient cable ref 63050025 6 suction cup electrodes ref 63030163 4 peripheral electrodes ref 63030105 Bottle gel ref 66020002 1 pack Z fold paper 210mm x 150mm x 30 metres ref 66010027 no longer available 1 pack Z fold paper 210mm x 140mm x 28 metres cod 66010045 ECG ruler User manual de de je b Je je je e CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 56 56
14. 10 25 50 mm s 5 Screen scrolling speed 12 5 25 50 mm s Thermal paper in rolls height 210x280mm length 17m 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 linear phase may be switched on off Anti drift Digital high pass 0 5 Hz linear phase always CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 53 56 CARDIOLINE ar2100viewbt Serial interface Keyboard Display Interpretation program Type of use Operating modes Options Battery capacity Recharging time Housing protection category Ambient conditions operation transport and storage enabled Infrared Membrane with 16 functional 33 alphanumeric and 1 LED keyboard extended monochrome type graphic LCD 320x240 pixels 5 7 inch display area120x89 mm Backlit with cold cathode fluorescent light Parameter calculation optional ECG interpretation optional Arrhythmia Program optional HRV RR variability optional Continuous Manual acquisition and printing in real time Automatic simultaneous acquisition Timed acquisition at user defined intervals Arrhythmia arrhythmic event recognition optional PC ECG real time acquisition with display
15. 6 56 CARDIOLINE ar2100viewbt Letter refer to the following paragraphs for the menus of configuration To correctly load the different types of paper If using paper in packs amp Open the paper compartment amp 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 amp 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 amp Open the paper compartment and remove the roll guide To avoid losing the guide place it in a safe place Jf replacing an empty roll retrieve the core before throwing away the empty roll amp 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 amp 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 Power supply control and management of the rechargeable battery Your electrocardiograph uses a dual power supply system a c mains and a rechargeabl
16. _ar2100viewbt_03_eng1 doc 32 56 CARDIOLINE ar2 100viewbt Select recording characteristics operating mode display and print format speed sensitivity filters Operating mode u The available recording modes Operating mode depend on the active configuration of the electrocardiograph gt A EI to select the desired mode the corresponding choice is displayed on the screen The options available are Automatic Manual Custom To change Custom mode see Settings During printing the active mode is printed on the information line of the printout Options Actions E All 12 ECG leads are recorded simultaneously 10 seconds Automatic ECG The signal printed out refers to the same time period and is saved The selected leads are recorded and printed out The Manual ECG recorded signal is in real time i e the trace is produced simultaneously with its acquisition Personalised See Personalised mode for details Display and print format Several different formats are available to display the ECG signal and several print types are available depending on the operating mode selected To select the desired display format the corresponding selection is displayed The options available depend on the operating mode selected Automatic mode and leads 3 3x2 6 6x2 Full Page 1 3x4 R for 1 page Full Page 3 3x4 3R for 1 page and 12 ch Manual mode 3 3x2 6 6x2 If Manual Mode is used the
17. able CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 um_ar2100viewbt_03_eng1 doc 52 56 www cardioline biz CARDIOLINE ar2100viewbt Technical specifications A c mains power supply Device specified class I 230 V 10 50 60Hz 115 V 10 50 60 Hz Maximum current absorbed 0 5 mA at 115 V 10 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 protection Pico fuse SHF SLO BLO T 5 A Littelfuse Classification EN60601 1 device class I Applied part type CF Class 93 42 EEC Directive IIa 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 with balanced electrode impedance Frequency response 0 05 150 Hz gt 3db Time constant 3 35 Acquisition 12 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 Signal memory 10 seconds for each lead in auto isochronous Recording sensitivity display Manual 5 10 20 mm mV Automatic dependent on number of channels printed Writing system Thermal printer a 8 dot mm Usable print height 210 mm Print channels 12 Print format Automatic mode 3 3x2 6 6x2 Full Page 3x4 R x1 e 3x4 3R x1 12x1 Manual mode 3 6 12 Paper transport speed 5 mm s
18. ains 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 mains with earth connection realised following the current regulations How to switch on the electrocardiograph amp The display lights up amp The display lights up indicating the active Use Profile When fully on the ECG signal and selected settings are displayed ready to proceed Warning if the symbols and BLE 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 How to switch off the electrocardiograph U The display switch off Settings related to the last recording are maintained in memory To know the effect of the turning off on the last automatic recording refers to the 8 Copy of a recording automatic ECG 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 Auto power off CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100vie
19. al and electronic equipment WEEE Medical electrical equipment Part 1 General requirements for safety Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Medical electrical equipment Part 2 25 Particular requirements for the safety of electrocardiographs Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analysing single channel and multichannel electrocardiographs Electromagnetic compatibility and Radio spectrum Matters ERM Electromagnetic Compatibility EMC standard for radio equipment and services Part 17 Specific conditions for 2 4 GHz wideband transmission systems and 5 GHz high performance RLAN equipment Electromagnetic compatibility and Radio spectrum Matters ERM Wideband transmission systems Data transmission equipment operating in the 2 4 GHz ISM band and using wide band modulation techniques Harmonized EN covering essential requirements under article 3 2 of the R amp TTE Directive CARDIOLINE is an et medical devices SpA brand Rel 1 1 Ed
20. at PC HRV heart rate variability analysis Paper Saving acquisition without printing Memories option ECG measurements option ECG interpretation option Arrhythmia option HRV Option PC archive option PC ECG Option Internal battery 1 hour in continuous recording and printing Internal battery 24 hours 100 IP 20 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 5000 grams without paper Conformity Directive 93 42 EEC Medical devices CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 54 56 CARDIOLINE ar2100viewbt 1999 5 EC 2002 96 EC Norms EN60601 1 1990 EN60601 1 A1 1993 EN60601 1 A2 1995 EN60601 1 A13 1996 EN60601 1 1 2001 EN60601 1 2 2001 EN60601 1 4 1996 EN60601 1 4 A1 1999 EN60601 2 25 1995 EN60601 2 25 A1 1999 EN60601 2 51 2003 ETSI EN 301 489 17 v 1 2 1 2002 08 ETSI EN 300 328 v 1 7 1 2006 10 User Manual um_ar2100viewbt_03_eng1 doc 55 56 Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity R amp TTE Waste electric
21. ay AN mee Tv 8 Or 1 00N User Manual CARDIOLINE ar2100viewbt CE 0470 english um_ar2100viewbt_02_eng1 Ed 1 1 18 02 2009 Cod 36510161 All rights reserved et medical devices SpA CARDIOLINE is a registered trademark of et medical devices SpA No part of this book may be reproduced in any form nor may it be stored in a retrieval system or transmitted in any form without written permission from et medical devices SpA Via De Zinis 6 38011 Cavareno TN Italy All the information included in this manual are subject to modification without notice In case of difference between user manual and device please refer to a representative CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 2 56 Contents Introduction 6 How to read the manual 7 Information and recommendations relating to safe use 8 Instructions for the Bluetooth transmission 9 The electrocardiograph 9 Parts symbols and controls 12 Installation and initial preparation 16 Selecting the installation site 16 Loading the thermal paper 16 If using paper in packs 17 If using rolls of paper 17 Power supply control and management of the rechargeable battery 17 Recharging the battery 17 How to switch on the electrocardiograph 18 How to switch off the electrocardiograph 18 Auto power off 18 Preparation for use the menu 20 How to access the menu 20 Structure of the me
22. ce 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 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 standard 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
23. cg amp 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 amp Emergency option allows to perform and eventually transmit an ECG exam taken in emergency situation in completely automatic mode T Note For more information on available options contact your selected dealer CONGRATULATIONS ON YOUR PURCHASE Your new computerised electrocardiograph CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 6 56 CARDIOLINE ar2100viewbt 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 How to read the manual In order to ensure the CARDIOLINE ar2100viewbt is operated in a safe and correct manner and to appreciate i
24. ctrodes potential defibrillation 47 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 4 56 Batteries low or in need of recharging 47 Print system control Out of paper 48 Status messages and error indication description and related event 48 Troubleshooting 48 Maintenance 50 Self test 50 Replacing the thermal paper 50 How to clean the device and the electrodes 51 Maintenance of the display 51 Periodic checks 51 Waste disposal 51 Technical information 52 Technical specifications 53 Basic accessories supplied 56 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 5 56 CARDIOLINE ar2100viewbt Introduction ar2100viewbt combines optimised performance in multichannel ECG recording equipped with graphic display and A4 format print system with all the features of reliability modularity versatility and upgradeability that characterise the latest generation of CARDIOLINE electrocardiographs ar2100viewbt is an electrocardiograph with dual power supply mains and rechargeable internal batteries which in the basic configuration will amp record an ECG exam in automatic manual and timed mode amp real time display of the ECG signal on the built in graphic display in 3 6 or 6 6 channel format amp reproduces the ECG signal on 210 mm paper in various formats tank to hi
25. display and print formats are the same to scroll the leads on the display To select the desired print format ED to select the desired format the corresponding choice is displayed on the screen CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 33 56 CARDIOLINE ar2100viewbt The available formats are as follows Format Type In Automatic mode the twelve ECG leads are printed out in groups of three each page presents one group Total no of pages per ECG 4 Additional pages if diagnosis aids e g Interpretation are available In Manual mode three leads In Automatic mode the twelve ECG leads are printed out in groups of six on each page Total no of pages per ECG 2 Additional pages if diagnosis aids e g Interpretation are available In Manual mode 6 leads per page continuously Zu In Automatic mode the twelve ECG leads are printed on a single page Total page pages per ECG 1 Additional pages if 12 ne diagnosis aids e g Interpretation are available In Manual mode twelve leads per page continuously pe e 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 in groups of six and each pa
26. e lead battery The rechargeable battery is housed inside the device and is protected against short circuits Caution before using the device it is necessary 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 empty MH the reserve charge is lower than 30 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 17 56 CARDIOLINE ar2 100viewbt Connect the electrocardiograph to the mains LED e 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 180 complete ECGs automatic recording mode 6 channel print format speed 25 mm s complete with analysis two A4 pages If the battery should be completely discharged symbol LCH it is still possible to make an ECG recording by connecting the device to the a c m
27. e performed due to excessive signal noise No data Impossible to obtain copy of the last recording AN amp Critical electrodes amp 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 Eh Batteries low Ch Batteries completely discharged Troubleshooting The following table summarises certain problems that may occur and the relative causes Problem Cause CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 48 56 CARDIOLINE ar2100viewbt Isoelectric line drift Interference from a c mains supply Muscle tremors Irregular paper transport Analysis impossible No copy of trace Abnormal signal User Manual um_ar2100viewbt_03_eng1 doc fo b b b E Use of electrodes other than originals Use of electrodes in saturation Insufficient electrode skin contact Electrode surface dirty Patient moving Voltage generator too close presence of other clinical instruments e g X rays etc Patient in contact with metallic parts or with other persons Patient not relaxed Peripheral electrodes adhering too tightly End of paper roll Paper roll incorrectly positioned Use of non original paper Signal too unstable or noisy Recording interrupted before 10 seconds have elapsed amp Defecti
28. elete amp User data e Profile name e Usere Institution e Ward Dept name e Reporting Doctor amp Editor e Yes User Manual um_ar2100viewbt_03_eng1 doc Rel 1 1 Ed 1 1 CARDIOLINE is an et medical devices SpA brand www cardioline biz 21 56 e No amp FP Print Report Management e Auto FP o Simultaneous o Sequential e FP Rhythm Leads o Channel 1 o Channel 2 o Channel 3 amp Lead sequence e Standard e Cabrera e Custom amp Configure Analysis e ECG measurements o Summary o ST amplitudes o Representative cycles e ECG Interpretation Summary Rhyth Interpretation Parameters o Representative cycles e None amp Configure Copy e Complete e ECG only 0000 e Analysis Only M amp Archive Management e Save o Automatic o Request o None e Deleting o Manual o Automatic e Autotrx last ECG o Yes o No e Emergency only amp HRV analysis CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 22 56 CARDIOLINE ar2100viewbt e Duration x e HRV Lead xxx amp Autotimer e No Intervals xx e Duration of intervals xx e Print Format o Auto o 3 leads amp Lead selection o 6 leads amp Lead selection amp Arrhythmia e RR advance RR delay Print advance Print delay Event print e ARR lead amp Print delay e Yes e No General Date Time Communication type amp Infrared amp Bluetooth select for u
29. er the recording can be printed or saved to PC archive Feature associated with memory option The twelve ECG leads are displayed in real time on your M Computer screen where thanks to the CARDIOLINE PC ECG software Real Time ECG it is possible to perform all the ECG recording operations The ECG signal is acquired in continuous mode and then V Aritmia printed in compressed format Any arrhythmic phenomena are highlighted on the trace M The signal is acquired and then reprocessed indicating the HRV analysis parameters and trends of the variation in heart rate CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 24 56 eY e EN ar2 O0viewbt The ECG archive u The menu allows the main archive management functions to be operated Options Actions Description available Displays the ECG list contained in the archive Scroll the list and select an exam patient The user can now View amp Archive the selected exam to a Personal Computer ArchPC amp Print the selected example Print amp Delete the exam selected Delete PCarchve 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 Clear BO message is displayed Settings The Settings menu allows different users to configure the func
30. ge 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 on a single page 2 5 secs for each lead 3x4 plus 10 secs for the Full Page 1 3x4 R rhythm leads up to 3 selected by the user in FP3 The Full Page 3 3x4 3R upper part of the page 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 recording on the display and on paper To select the scrolling speed of the displayed signal the corresponding value is displayed The options available are 12 5 mm s 25 mm s and 50 mm s To select the printing speed CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 34 56 CARDIOLINE ar2100viewbt ED 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 all mm mV and 20 mm mV the corresponding value is displayed The options available are 5 mm mV 10 To select the sensitivity of rec
31. gh resolution thermal printer 3 3x2 6 6x2 Full Page 1 3x4 R for 1 page Full Page 3 3x4 3R for 1 page and 12 channels amp organize recordings thanks to the clock date stamp and extended alphanumeric keyboard to manage user and patient data amp set up to 4 different user profiles to tailor how the device functions to differing requirements Thanks to the flexibility of the software used and to the infrared interface the ar2100viewbt 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 ar2100viewbt can be equipped with amp Memory option storage of up to 40 full ECG exams with no need to print out immediately on paper paper saving mode amp ECG parameters option automatic ECG parameter measurement program ECG analysis option a useful and dependable diagnostic support amp arrhythmia option a program enabling detection of arrhythmia events during continuous recording amp HRV analysis option a program enabling detection of variations in heart rate amp PC archive option for saving the exam to archive stored in a personal computer running CARDIOLINE software cubee
32. he archive can contain up to 40 recordings for subsequent processing or transfer to PC Memory option amp Start automatic or on demand at the end of a recording see Settings amp If On Demand the patient file is displayed at the end of an automatic recording Two options are available Save amp Esc and Confirm amp Esc Select Save amp Esc to save the trace or Confirm amp Esc if you do not wish to save the trace In this case the will remain available for copies until a new recording is made or until the device is switched off Warning the number of tests in the memory and the percentage of space available can be checked inside trhe main screen 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 After selectioning ECG archive S to select the desired action 1 Display 2 Archive PC 3 Print List 4 Empty 1 scroll pages if more than 1 activate the find function research key last name L to confirm the desired action For details of the options available see ECG Archive Saving to Personal Computer archive u 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
33. he 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 9 56 Front view CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 10 56 CARDIOLINE ar2 100viewbt Side view CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 11 56 aJ 1m e 1 113 ar2100viewbt Parts symbols and controls 1 Keyboard Messages amp Symbols displayed Associated LED amp LED on device connected to mains power internal battery charging L full symbol battery charged part empty symbol battery on off 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 select start contact saturation operating mode interrupt current operation stop amp Automatic recording N Manual recording amp Recording mode selected in configuration phase Custom mode select Mi mode m amp Automatic mode formats available Select ECG 3 3x2 6 6x2 format selections are
34. hythm 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 To start the recording the message Paper Battery will appear If the signal has not yet been initialised the message Wait will be displayed amp The patient data entry procedure now starts see Patient data entry amp 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 45 56 j to interrupt stop K Defibrillation If defibrillation occurs the oz 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 ap
35. l products Warning if the display panel should break do not swallow the liquid released If this should come into contact with skin or clothing wash immediately using copious quantities of soap and water High pressure during use can cause fonts to be displayed abnormally Normal operations will be re established Periodic checks To ensure correct and long lasting operation of the device it is necessary tohave an Authorised Assistance Centre carry out the following checks amp paper drive speed calibration every year cleaning of paper compartment paper presence sensor and writing system every year integrity of cables and connectors every year by means of an ECG simulator general check of functional efficiency of the device and leakage currents every 2 years 4 b T Waste disposal In compliance with the WEEE 2002 96 EC Directive the product and all of his parts patient cables batteries etc cannot be treated as domestic waste For further information on the disposal contact the competent office of your city or a Cardioline Assistance Center CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 51 56 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 service
36. lar 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 For further information contact directly CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 7 56 CARDIOLINE ar2100viewbt aa 7 Customer Support Centre Tel 39 02 95051890 e mail csc etmed biz Information and recommendations relating to safe use T 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 devi
37. le to the connector aD identified with the symbol 181 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 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 amp 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 amp Clean the skin thoroughly with alcohol or ether at the areas where the electrodes will be placed amp Connect each colour coded plug of the patient cable to the respective electrode observing the colour position matches indicated below Colour Symbol Electrode position CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 31 56 CARDIOLINE ar2100viewbt Red R Right arm Yellow L Left arm Green F Left leg Black N Right leg White
38. nces the rhythm lead selection menu Three options are available Standard amp Cabrera amp Custom 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 Inside the single menus D to enable disable a section amp 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 PQ QRS and QTr wave amplitudes frontal vectors axes If present includes the report prepared using the Editor function ST Parameters printout of table of ST depression values on the twelve leads Templates printout of templates relative to the twelve leads amp ECG Interpretation 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 If present includes the report prepared using the Editor function Rhythm Analysis print rhythm strip and diagnosis Interpretation processi
39. ng 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 Configure Copy The Copy key can be configured M Analysis configuration CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 27 56 CARDIOLINE ar2100viewbt Complete the last automatic recording is printed out in full ECG only only ECG of last automatic recording is printed out Analysis only only analysis of last automatic recording is printed out i The way in which ECG traces are saved can be set and the memorystatus checked If the device is being used in Paper Saving mode saving is always automatic Save Automatic trace saved automatically after acquisition without action by operator The operation is indicated on the display by the following messages Saving and ECG saved In this case a report cannot be edited with the Editor function On Demand on completion of the recording or reporting phases Editor enabled the option Save amp Exit Press to continue If you do not want to save the trace select Confirm amp Esc A copy of the trace Archive management remains available until a new recording is made
40. nu 21 Menu activated operation and customization of the electrocardiograph24 Customise mode M 24 The ECG archive M 25 Settings 25 Use profiles 25 General 29 Password 29 Tools 29 Preparing for an ECG recording 31 Connecting the patient cable 31 Preparing the patient and applying the electrodes 31 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 3 56 CARDIOLINE ar2100viewbt Select recording characteristics operating mode display and print format speed sensitivity filters 33 Operating mode u 33 Display and print format 33 Speed of recording on the display and on paper 34 Sensitivity of recording on the display and on paper 35 Recording filters 35 Recording of a rest ECG 36 Patient data entry 36 Recording in manual mode 37 Recording in automatic mode 37 Editing a report 38 Automatic calculation of ECG parameters M 39 Automatic ECG interpretation u 39 Copy of an automatic ECG recording 40 ECG memory saving a recording u 41 ECG memory archive management M 41 Saving to Personal Computer archive M 41 Recording in Emergency mode u 42 Recording in ECG Autotimer mode 43 Paper Saving mode 43 Recording in PC ECG mode u 44 Recording in HRV Analysis mode M 44 Recording in Arrhythmia mode M 45 Defibrillation 46 Management and control of electrocardiograph functionalities 47 Disconnected ele
41. onsidered Reported by name of Reporting Doctor If the Memory Option is not installed E E to select the Confirm amp Esc option and record the report To execute the selected action If the Memory Option is installed CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 38 56 CARDIOLINE ar2 100viewbt K to select the Save amp Esc option and archive the test or Confirm amp Esc to record the report without the save procedure a to execute the selected action to print a copy of the trace complete with report 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 amp Start automatic at the end of the recording amp Stop automatic at the end of printing the report The message Analysis OK is displayed amp When analysis and printing is complete if the Editor function is enabled the patient file is displayed see Editing a report It is therefore possible to change and add to the information obtained in the Summary section el The principal items of information in the report are amp computed value of the following parameters heart rate rhythm type P QT QTc PQ QRS and QTr wave amplitudes frontal vectors axes
42. or the device is switched off None saving disabled amp 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 amp 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 The following can be set duration of the test 1 to 5 minutes HRV analysis and 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 V Arrhythmia amp The RR advance in percentage amp The RR delay in percentage M Archive management ECG Autotimer CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 28 56 ray N m a 1 1103 ar2100viewbt amp 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 amp The Print Delay how many seconds of normal ECG after the last event min 2 sec max 10 sec amp Event Print enable the abnormal ECG printout during the test
43. ording on printing Hl ED x the corresponding value is displayed The options 5 mm mV 10 mm mV and 20 mm mV During printing the recording sensitivity is indicated on the information line Note selecting 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 twelve lead 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 both the displayed and 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 to activate the filters 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 activated filters are indicated on the information line 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
44. proved electrodes supplied with the electrocardiograph have been designed so as to minimise the risk in case of accidental contact CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 46 56 CARDIOLINE ar2100viewbt Management and control of electrocardiograph functionalities 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 amp 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 arm electrode and of electrode C1 amp 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 OLL 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 Automa
45. quisition OK The patient can now be disconnected CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 37 56 CARDIOLINE ar2100viewbt E g 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 Editing a report The Editor function allows a report with comments to be prepared directly on the electrocardiogram at the end of each automatic recording 20 lines of 52 characters are available 12 if diagnostic aids are available The reporting phase may be protected with an access Password see Settings This function is not accessible if in Paper Saving mode or if automatic recording saving is set amp At the end of the recording the patient file is displayed to select the Edit option to access the editor and prepare the report Enter password if requested 0 Z Z to move around inside the file K to display the management options available Conf amp Esc to confirm and exit Delete whole line Cut line Add line to execute the selected action without saving the changes to exit er to prepare the report E to delete the character highlighted by the cursor to select Confirm to confirm the data and return to the patient file Once the report has been confirmed the test is c
46. raph 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 How to access the menu E to access the menu from the main screen Main Menu Personalize Mode ECG Archive Settings Tools a Meru ddl ess l69 19 E 00 ood to scroll through the menu items E executes the action associated with the symbol displayed access the lower level menu select and confirm E to scroll multiple selections If available symbol displayed CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 20 56 E E to return to the previous level Structure of the menu CARDIOLINE ar2100viewbt The menu is organised in four sections Custom mode ECG archive 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 amp Custom mode Emergency Paper Saving PCECG Arrhythmia Monitor u HRV analysis M ECG autotimer ECG archive View PC Archive Print Delete PC Archive Print List Clear amp Settings Operation profile Select profile Profilei Profile2 Profile3 Profile4 Set Profile Change New D
47. s 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 to start printing a copy The message Copying is amp displayed E 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 40 56 CARDIOLINE ar2 100viewbt 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 T
48. s 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 do not run the service self test without a qualified technician in attendance 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 50 56 CARDIOLINE ar2100viewbt 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 Maintenance of the display amp Keep the display dry avoiding condensate formation If condensate forms the liquid crystals could be damaged amp Use a soft cloth to clean the surface of the display Use of rough cloths could scratch the surface Do not use solvent based chemica
49. se in PC ECG mode Units Cm Kg amp Inch Pound Page format Mains filter 50Hz 60 Hz Display amp Brightness amp Contrast Recorder ID Password Tools About Print Configuration Default Configuration Self test User CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 23 56 CARDIOLINE ar2100viewbt amp Display amp Keyboard amp Printer amp Memory amp About Service Only available to Technical Service Menu activated operation and customization 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 Customise mode M The menu allows one of the enabled modes to be added to the direct selection of traditional vn Y operating modes Automatic and Manual The mode selected is displayed in the lower left corner of the main screen Options Actions Description available The recording starts immediately pressing start key If the V Emergency automatic interpretation is enabled analysis will be performed considering a person of 35 years old gender male The ECG trace is recorded and saved without any hard copy of the signal generated The steps and the quality of the V Paper saving recording are monitored through messages in the display Thereaft
50. ss system related information and activate the self test and setting functions of the device CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 29 56 Options Actions Description available Displays the recorder identification data software version About installed and language Print Configuration a the general recorder configuration and use profiles l To restore the ECG to factory configuration cancelling the Default Configuration settings selected There are two self test menus available User and Service Self test Do not run the service self test without a qualified technician in attendance For details see Maintenance CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 um_ar2100viewbt_03_eng1 doc 30 56 www cardioline biz CARDIOLINE ar2100viewbt Preparing for an ECG recording This section describes the preliminary operations required when recording an at rest electrocardiogram with the CARDIOLINE ar2 ooviewbt 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 activation of filters Connecting the patient cable Connect the terminal plug of the patient cab
51. the time of recording format xx yy min to scroll the leads on the display during the test lt to start manual recording inside an interval the print format corresponds to the format selected on the display to pause manual printing F to interrupt the test 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 lt a g to start the recording If the signal has not yet been initialised the message Wait will be displayed amp The patient data entry procedure now starts see Patient data entry Patient data are mandatory amp 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 43 56 CARDIOLINE ar2 100viewbt amp 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 Recording in PC ECG mode M Associated with the CARDIOLINE software your ar2100vie
52. tic 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 oz symbol is displayed See Defibrillation Batteries low or in need of recharging When the BCE 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 CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 47 56 CARDIOLINE ar2100viewbt 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 of paper or Printer are displayed for 3 seconds approx 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 b
53. tions of the electrocardiograph as best suits their individual working methods Configurable characteristics are grouped together in three menus Use profiles General and Passwords Use profiles Up to four different Use profile can be saved This facility enabled the recorder to be modified for different use requirements in just a few seconds Accessing the Use Profiles menu the user can amp recall an existing profile Select Profile The list of saved Profiles is displayed Select the desired Profile therecorder settings are changed correspondingly amp seta new profile Set Profile A new Profile New can be created or a programme can be 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 Uigsr Data A Profile Name 8 characters User Institution Name 30 characters Ward Dept Name 16 characters and Name of CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 25 56 CARDIOLINE ar2100viewbt Patient data management Editor FP Print Report Management Reporting Doctor 13 characters can be entered The User Institution and Ward Dept Name will be printed on all documents and sent to the PC when data is saved The profile name is
54. ts 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 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 ar2100viewbt in traditional ECG procedures and an introduction to the use of particu
55. 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 amp Position the electrocardiograph relative to the infrared adapter connected previously to the PC as illustrated in the following figure CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 41 56 CARDIOLINE ar2100viewbt ee 7 89 EBEN E to start transfer EA g 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 amp Position the electrocardiograph as indicated previously amp Select the ECG archive menu and proceed as appropriate For details of the options available see ECG archive 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
56. ue 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 Filters on off indicator In automatic and paper saving mode displays number of tests in memory and space available in Autotimer HRV and Arrhythmia mode displays duration of tests CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 14 56 CARDIOLINE ar2100viewbt Time indicator m Battery status indicator n Operating information and error message area In Menu mode indicates the active keys and the presence of additional options Display management keyboard U9 E Cancel operation delete text return to previous menu E lt gt amp scroll menus and information In main screen scroll leads on display Access to Menu If available scrolls multiple selections displayed QWERTY alphanumeric keyboard for patient data management amp Special characters are associated with each key and can be displayed by pressing the key in sequence A p E displays the symbols and special characters map E 00 amp to select to copy the symbol into the text delete text gt confirm 5 ie type patient cable connector protected against defibrillation as indicated by the symbol 6 Paper compartment door 7
57. used to retrieve the settings Ar Patient data can be entered and updated at any time U 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 T je je de b de b hb Je de b E When Yes is selected the patient record file is displayed at the end of a recording and the Report management screen can be accessed 20 lines of 52 characters 12 if diagnostic aids are available are available If auxiliary diagnostic tools are enabled the Summary Diagnosis is displayed again and it can be changed or completed If No is selected the report preparation function is not managed amp Auto FP 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 amp FP Rhythm Leads The reference leads can be set for rhythm in FP formats 3x4 R and 3x4 3R essen The sequence of leads printed can be selected As well as q modifying the order in which the leads are printed out the User Manual um_ar2100viewbt_03_eng1 doc CARDIOLINE is an et medical devices SpA brand Rel 1 1 Ed 1 1 26 56 www cardioline biz CARDIOLINE ar2100viewbt selection also influe
58. ve patient cable Defective electrodes CARDIOLINE is an et medical devices SpA brand Rel 1 1 Ed 1 1 www cardioline biz 49 56 CARDIOLINE ar2100viewbt Maintenance 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 E gt to select the type of test required E to start the test Tests available 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 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 Memory a message relating to the statu
59. wbt becomes a PCbased acquisition system For details on the use of the application software consult the specific manual Having selected PC ECG mode see Operating mode amp Position the electrocardiograph relative to the infrared adapter connected previously to the PC as illustrated in the following figure A ee ae RGG oo E oc i L S IHI HT TT a to start transmission The message Wait is displayed followed by a scroll bar During the transmission the ECG leads are also displayed on the recorder display 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 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 CARDIOLINE is an et medical devices
60. wbt_03_eng1 doc 18 56 CARDIOLINE ar2100viewbt 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 7he procedure is activated only after the current operation has been completed amp After 10 min has elapsed without any key being pressed reserve power gt 30 amp After 1 min has elapsed without any key being pressed reserve power between 15 and 30 ELA After 10 sec have elapsed without any key being pressed reserve power lt 15 L 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 amp 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 je je b je b T CARDIOLINE is an et medical devices SpA brand User Manual Rel 1 1 Ed 1 1 www cardioline biz um_ar2100viewbt_03_eng1 doc 19 56 CARDIOLINE ar2 100viewbt Preparation for use the menu Navigating within the menu of your ar2100viewbt there are options for intuitive customization of the operating modes using the dedicated display keys To ensure your electrocardiog
61. y 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 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 amp 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 amp 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 amp In the EKG program the category A diagnostic suggestions are obtained using a multivariate alternative classification that i

Cardioline AR2100viewbt - User manual

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