Cardioline ECG100+ User Manual
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Cardioline ECG100+ User Manual

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ECG100+ - ECG200+
ECG100S - ECG200S
User manual
Rev. 08 – 21.01.2019
1936

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Summary of Contents for Cardioline ECG100+

  • Page 1 ECG100+ - ECG200+ ECG100S - ECG200S User manual Rev. 08 – 21.01.2019 1936...
  • Page 2 ECG100+ - ECG200+ - ECG100S - ECG200S All rights reserved © Cardioline SpA. CARDIOLINE® is a registered trademark of Cardioline SpA. This publication may not be reproduced, in whole or in part, in any form or manner, without prior written authorisation...

  • Page 3: Table Of Contents

    ECG100+ - ECG200+ - ECG100S - ECG200S Table of Contents GENERAL INFORMATION .........................4 1.1. Other important information ......................4 SAFETY INFORMATION ..........................5 2.1. Wireless Data Transmission ......................10 2.2. Wirless Option ..........................10 ELECTROMAGNETIC COMPATIBILITY (EMC) .....................12 3.1. Guidance and Manufacturer's declaration - Electromagnetic emissions .........13 3.2.
  • Page 4 ECG100+ - ECG200+ - ECG100S - ECG200S 7.2.1. Preparing the patient .......................34 7.2.2. Connecting the patient ......................35 7.3. Viewing the ECG ..........................37 7.3.1. Disconnection of the leads .......................38 7.4. Entering patient data ........................38 7.4.1. Manually entering the patient's data ..................39 7.4.2.
  • Page 5 ECG100+ - ECG200+ - ECG100S - ECG200S 9.3. Audit trail ............................60 10. CONNECTIVITY, RECEIVING WORK LISTS AND TRANSMITTING ECG EXAMS ..........61 10.1. General ............................61 10.1.1. Configuring LAN connectivity ....................61 10.1.2. Configuring WLAN connectivity ....................62 10.2. USB connectivity ..........................62 10.2.1. Connection to a computer .......................63 10.2.2.
  • Page 6 ECG100+ - ECG200+ - ECG100S - ECG200S...

  • Page 7: General Information

    Other important information This manual was written with the utmost care. Should you find any details which do not correspond to those contained in this manual, please inform Cardioline SpA who will correct such inconsistencies as soon as possible. The information contained in this manual is subject to change without notice.

  • Page 8: Safety Information

    SAFETY INFORMATION SAFETY INFORMATION Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if: 1. the assembly operations, modifications or repairs are carried out by Cardioline SpA or by its Authorised Service Centre;...
  • Page 9 UL 60601-1, IEC 60601-1 and IEC 60601-2-25 standards. Only use spare parts and accessories supplied with the device and available from Cardioline SpA. Refer to section 12.2 for the list approved accessories. ...
  • Page 10  The internal rechargeable battery is hermetically sealed NiMH and requires no maintenance. Should the battery be faulty, contact Cardioline's technical assistance service.  The low battery warning is designed for the recommended batteries only. Using other types of batteries may lead to a lack of indication resulting in device failure.
  • Page 11 ECG100+ - ECG200+ - ECG100S - ECG200S SAFETY INFORMATION  Do not clean the device or the patient cables by submersing them in liquid, autoclaving, or steam cleaning. This may cause serious damage to equipment or reduce its lifespan. Using non-specific detergents/disinfectants, failure to comply with the recommended procedures or contact with non- specific materials may cause additional risks to operators, patients or bystanders or may damage the device.
  • Page 12 ECG100+ - ECG200+ - ECG100S - ECG200S SAFETY INFORMATION  If the electrodes are not properly connected to the patient, or one or more patient leads are damaged, the display will indicate a lead failure. When the ECG is printed, these leads will come out on paper as a square wave.

  • Page 13: Wireless Data Transmission

    RF sources may interfere with the transmission generated by the device. Cardioline SpA has tested the coexistence of the device with other devices that can interfere such as devices using WLAN, Bluetooth radio and/or cell phones. Although the current technology allows a very successful rate of transmission, it is possible that in some rare occurrences, the system may not perform at its best resulting in a “failed transmission”.
  • Page 14 ECG100+ - ECG200+ - ECG100S - ECG200S SAFETY INFORMATION In order to achieve the best transmission rate, it is necessary that the facility where the device is operated can provide good area coverage. Please consult the IT personnel of the facility to verify the proper WLAN availability in the area where the device will be used.

  • Page 15: Electromagnetic Compatibility (Emc)

     The use of accessories and cables other than those recommended by Cardioline may cause an increase in emissions or a lowering in the protection of the system. ...

  • Page 16: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    ECG100+ - ECG200+ - ECG100S - ECG200S ELECTROMAGNETIC COMPABILITY (EMC) Fixed, portable and mobile equipment for RF communication may affect the protection of the medical equipment. See par. 3.4 for the recommended separation distance between the radio equipment and the device.

  • Page 17: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    ECG100+ - ECG200+ - ECG100S - ECG200S ELECTROMAGNETIC COMPABILITY (EMC) 3.2. Guidance and Manufacturer's declaration - Electromagnetic immunity The ECG100+/ECG200+/ECG100S/ECG200S is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG100+/ECG200+/ECG100S/ECG200S should assure that it is used in such an environment.
  • Page 18 ECG100+ - ECG200+ - ECG100S - ECG200S ELECTROMAGNETIC COMPABILITY (EMC) distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: From 80 MHz to 800 MHz 3 V/m From 800 MHz to 2.5 GHz Radiated RF From 80 MHz to 2.5 3 V/m IEC 61000-4-3...

  • Page 19: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Ecg100+/Ecg200+/Ecg100S/Ecg200S

    ECG100+ - ECG200+ - ECG100S - ECG200S ELECTROMAGNETIC COMPABILITY (EMC) 3.4. Recommended separation distances between portable and mobile communications equipment ECG100+/ECG200+/ECG100S/ECG200S The ECG100+/ECG200+/ECG100S/ECG200S is intended for use in an electromagnetic environment in which radiated disturbances controlled. customer user ECG100+/ECG200+/ECG100S/ECG200S can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ECG100+/ECG200+/ECG100S/ECG200S as recommended below, according to the maximum output power of the communications equipment.
  • Page 20 ECG100+ - ECG200+ - ECG100S - ECG200S ELECTROMAGNETIC COMPABILITY (EMC) 16-QAM, 64Q-AM 2.437 9.27 9.67 5.65 5.89 802.11G CCK, OFDM, BPSK, GPSK, 16-QAM, 64Q-AM 2.480 9.64 9.84 5.87 802.11G CCK, OFDM, BPSK, GPSK, 16-QAM, 64Q-AM 2.412 11.53 10.62 7.03 6.47 802.11N CCK, OFDM, BPSK, GPSK, 16-QAM, 64Q-AM...

  • Page 21: Symbols And Label

    ECG100+ - ECG200+ - ECG100S - ECG200S SYMBOLS AND LABEL SYMBOLS AND LABEL 4.1. Explanation of the symbols Symbol Description Comply with the instructions in the use manual CE marking – compliance with the European Union directives Manufacturer Reference number (product code) Serial Number Lot number Year of manufacture...

  • Page 22: Device Label

    ECG100+ - ECG200+ - ECG100S - ECG200S SYMBOLS AND LABEL 4.2. Device label ECG100+ ECG200+ ECG100S ECG200S RF Symbol beside the connectors in the rear part of the device (see par. 5.4.1).

  • Page 23: Introduction

    ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION INTRODUCTION 5.1. Purpose of the manual This manual deals with the ECG100+/ECG200+/ECG100S/ECG200S devices. The manual represents a guide for the execution of the following operations:  Reasonable use of the electrocardiograph, of the function keys and of the sequence of menus. ...

  • Page 24: Description Of The Device

    ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION  The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.  The device is indicated for use on adult and paediatric populations. ...

  • Page 25: General Overview

    ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION 5.4.1. General overview Front view: ECG100+ Display Thermal printer Keyboard ECG200+ Display Thermal printer Keyboard...
  • Page 26 ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION ECG100S Display Thermal printer Keyboard ECG200S Display Thermal printer Keyboard...
  • Page 27 ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION Rear view: Mini USB connector Power supply Side view: Patient cable input...
  • Page 28 ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION Display and keyboard: ECG100+/ECG200+ Display Function keys On/Off switch Hot keys Complete keyboard ECG100S/ECG200S Display Function keys On/Off switch Hot keys Complete keyboard...

  • Page 29: Keyboard

    ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION Function keys Display Labels Display with traces and function keys labels 5.4.2. Keyboard The electrocardiograph is equipped with a complete alphanumerical keyboard for entering numbers, characters and symbols. The keyboard also has hot keys, to easily activate the main operations, and some function keys.

  • Page 30: Display

    ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION Special symbols and characters Pressing “SYM”, when a text field is selected, grants access to the special symbols and characters menu. Symbols and special characters menu Using the function keys is possible to move between characters and select them: ...
  • Page 31 ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION  Surname, Name: surname and name of the patient being examined, if entered.  Heart Rate (HR): when a patient is connected to the device, his/her HR is viewed in real time. ...
  • Page 32 ECG100+ - ECG200+ - ECG100S - ECG200S INTRODUCTION Memory Patient Heart rate Messages Status name Name of Function traces keys Clock Speed, gain WiFi and filter Battery status...

  • Page 33: Preparation For Use

    Patient cable connection Connect the patient cable terminal plug to the connector on the side of the electrocardiograph. The connector is so designed that the patient cable can only be inserted one way, with the “Cardioline” logo on the plug facing upwards.

  • Page 34: Loading The Paper

    ECG100+ - ECG200+ - ECG100S - ECG200S PREPARATION FOR USE 6.3. Loading the paper Load paper in the electrocardiograph as follows: 1. Remove the outer packaging of the ream of paper. 2. Open the printer compartment, lifting the panel and turning it anticlockwise around its pivot. 3.

  • Page 35: Power Connection

    NOTE: after printing it is important that the paper is cut by pulling it to the right instead of to the left. If the paper is pulled towards the left the door may accidentally open, thus causing problems with any subsequent prints. NOTE: For the best performance of the thermal printer, use the thermal paper recommended by Cardioline. 6.4. Power connection The electrocardiograph can also be powered by battery, disconnected from the mains.

  • Page 36: Battery Operation

    ECG100+ - ECG200+ - ECG100S - ECG200S PREPARATION FOR USE 6.5. Battery operation When the electrocardiograph is not plugged in, it is powered by battery. When the device is switched on the “unknown level” icon is displayed until the actual battery level is measured.

  • Page 37: Execution Of An Exam

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM EXECUTION OF AN EXAM 7.1. General procedure To acquire an ECG proceed as follows: 1. Prepare and connect the patient (as described in Par. 7.2) 2. Check the display to verify the quality of the tracings and to make sure there are no error messages (as described in Par.

  • Page 38: Connecting The Patient

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM  Dry the skin vigorously with an abrasive pad, such as a 2x2 or 4x4 gauze, to remove dead skin cells and fat. NOTE: Pay attention not to cause abrasions, discomfort or bruises on the skin. Always observe the utmost clinical discretion when preparing the patient.
  • Page 39 ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM NOTE: It is important to locate the fourth intercostal space for an accurate positioning and monitoring of the precordial leads. It is possible to locate the fourth intercostal space starting from the first intercostal space. Given the variable conformation of the patient, palpating the first intercostal space accurately can be difficult.

  • Page 40: Viewing The Ecg

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM 7.3. Viewing the ECG The electrocardiograph starting screen is the real time display. Real time display Display and function keys The display shows ECG traces in real time, some basic information (name and surname of the patient, heart rate, speed, gain, filter and battery charge, as indicated in Par.

  • Page 41: Disconnection Of The Leads

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM Message area Real time display with warning message. 7.3.1. Disconnection of the leads If one or more electrodes are disconnected the message “Lead fail” followed by the list of leads in fail is displayed.

  • Page 42: Manually Entering The Patient's Data

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM Screen for patient data input. NOTE: make sure patient data are cleared and retyped before acquiring an ECG for a new patient, as they are not automatically reset after an exams. Patient data are automatically cleared only when the device is turned off or use function key New Id –...

  • Page 43: Automatically Entering The Patient's Data

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM  F2 () to move down.  F3 () to scroll the list of the possible items associated with a field (such as sex and race). The other function keys allow you to: ...

  • Page 44: Acquisition Of An Ecg

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM The other function keys allow you to:  F5 (Select) load the selected order and to go back to the initial screen  F6 (Cancel) go back to the initial screen without loading any data NOTE: if the order contains the fields VisitID and ReasonForStudy, these are automatically saved in the file SCP of the examination performed starting from that order, even though they are not visible from the ECG machine.
  • Page 45 ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM If the automatic printing option (Par.8.6.2) is enabled, the examination is printed automatically at the end of the acquisition. In the same way, if the automatic saving option (Par. 8.6.2) is enabled, the examination is saved automatically at the end of the acquisition.

  • Page 46: Manual Acquisition Of An Ecg (Manual)

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM 7.5.2. Manual acquisition of an ECG (MANUAL) Pressing the MANUAL key on the real time display screen starts manual acquisition and printing of the ECG tracing. Display during manual acquisition of an ECG Function keys The function keys allow you to modify the printing parameters of the ECG: ...

  • Page 47: Identifying Urgent Ecgs (Stat)

    7.6. Identifying urgent ECGs (STAT) The acquired examinations can be identified as “urgent”, for example for flagging as such in Cardioline WebApp or in an archive. Once the ECG has been acquired it can be given the “urgent” status by pressing the F3 function key (STAT).

  • Page 48: Printing Formats

    ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM It is also possible to start manual printing by using the MANUAL hot key on the real time display screen (Par. 7.5.2). NOTE: the heart rate shown in print is that calculated as the average of the 10 s rhythm printed. It may therefore be different from that shown on the display before printing, which instead corresponds to the rate in real time.
  • Page 49 ECG100+ - ECG200+ - ECG100S - ECG200S EXECUTION OF AN EXAM The examination can be transmitted automatically or manually (using the LINK key) at the end of the acquisition, as described in par. 7.5.1, depending on whether the “Autosave” function is active in the Settings (par.

  • Page 50: Menu And Device Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS MENU AND DEVICE SETTINGS 8.1. Main menu The main menu can be accessed by pressing the F6 function key (Menu) on the real time display screen. Main menu screen Function keys From the Main menu, you may access the various sections using the corresponding function keys: ...

  • Page 51: Work Lists

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS 8.2. Work lists If the electrocardiograph has the Connectivity option, it is capable of downloading the work lists generated by the server it is connected to. Worklist screen Display and function keys The work lists are displayed on a specific screen, reached from the Main menu (with the F1 function key (Worklist)) or from the patient's data screen (as described in Par.

  • Page 52: Ecg Archive

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS 8.3. ECG archive The electrocardiograph can save up to 100 ECG's (1000 if the extended memory option is enabled). To access the ECG archive, press the F2 key (ECG Archive) on the Main menu. ECG archive screen Display and function keys The stored examinations are viewed as a list, each including:...

  • Page 53: Archive Full

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS The following hot keys are also enabled in the archive screen:  LINK: if the connectivity option of the electrocardiograph is enabled, it allows you to send all of the ECG's not transmitted (“non-transmitted”...

  • Page 54: Print Configuration

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS Display and function keys You may shift among the fields of the page by using the function keys:  F1 () to move to the previous field,  F2 () to move to the following field, ...

  • Page 55: Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS  Number of orders and stored ECG's 8.6. Settings The settings menu consists of several pages that allow to change the device settings. To move between the pages and between the fields of each page, use the function keys: ...

  • Page 56: Default Ecg Settings

    Option is DICOM and allows to choose if the ECG100+/ECG200+) DICOM transmission has to be done using an external gateway (Cardioline Gateway), If set to Yes the external gateway is used. Configuration PIN Allows to set a 4 digits PIN in order to protect the Numeric (4 digits) access to settings.

  • Page 57: Manual Printing Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS Field Description Possible values applied. The 150 Hz filter is available only if using a sampling frequency of 1000 Hz. Speed Initial speed of the tracings. 50/25/10/ 5 mm/sec If changed, it needs the device reboot to be applied.

  • Page 58: Connectivity Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS Field Description Possible values Rhythm Lead 2 rhythm lead (3x4+3) From I to V6 (default VI) Rhythm Lead 3 rhythm lead (3x4+3) From I to V6 (default V5) No. copies Number of printed copies.

  • Page 59: Lan Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS Field Description Possible values Connectivity Settings (page 5) Cart # Device identification number. From 0 to 65535 Department ID Department identification number. From 0 to 65535 Time Server Server address for automatic synchronisation of Alphanumerical (256 time (if enabled).

  • Page 60: Wlan Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS 8.6.7. WLAN Settings (page 7) Field Description Possible values DHCP DHCP on or off. With DHCP “On”, the network On/Off automatically and dynamically assigns an IP address to the device and therefore it is not necessary to enter an IP address manually.

  • Page 61: Protection Of The Settings

    ECG100+ - ECG200+ - ECG100S - ECG200S MENU AND DEVICE SETTINGS Field Description Possible values Test Button to test the wifi connectivity Enable WiFi Enable/Disable the WiFi antenna of the device On/Off make WLAN settings page accessible/inaccessible. 8.7. Protection of the Settings You can set a security code (PIN) that allows access to the settings section to be protected.

  • Page 62: Set The Device In Accordance With Gdpr (General Data Protection Regulation)

    ECG100+ - ECG200+ - ECG100S - ECG200S SET THE DEVICE IN ACCORDANCE WITH GDPR (General Data Protection Regulation) SET THE DEVICE IN ACCORDANCE WITH GDPR (General Data Protection Regulation) 9.1. General information The electrocardiograph provides a series of features (described in the table below) that can be used by the Data Controller in order to comply with the minimum requirements of EU Regulation 2016/679, known as GDPR (General Data Protection Regulation).

  • Page 63: Audit Trail

    ECG100+ - ECG200+ - ECG100S - ECG200S SET THE DEVICE IN ACCORDANCE WITH GDPR (General Data Protection Regulation) At startup, the device works in anonymous access mode. To enable the full access mode, insert an NFV reader into the USB socket, with which to scan an adequately configured NFC card. Similarly, after a period of inactivity, the device automatically returns to the anonymous access mode and full access is restored by scanning the NFC card again.

  • Page 64: Connectivity, Receiving Work Lists And Transmitting Ecg Exams

    ECG100+ - ECG200+ - ECG100S - ECG200S CONNECTIVITY, RECEIVING WORK LISTS AND TRANSMITTING ECG EXAMS CONNECTIVITY, RECEIVING WORK LISTS AND TRANSMITTING ECG EXAMS 10.1. General ECG100+/ECG200+/ECG100S/ECG200S electrocardiographs are all equipped with a USB port and they can be optionally equipped with: ...

  • Page 65: Configuring Wlan Connectivity

    ECG100+ - ECG200+ - ECG100S - ECG200S CONNECTIVITY, RECEIVING WORK LISTS AND TRANSMITTING ECG EXAMS LAN connector 10.1.2. Configuring WLAN connectivity If the WLAN option is enabled the transmission can be wireless. The connection parameters for LAN connectivity must be configured correctly, as indicated in Par. 8.6.1. In particular, if the DHCP is set at “No”, the WLAN access point will have a static network setting and the following parameters must be configured in the electrocardiograph: ...

  • Page 66: Connection To A Computer

    ECG100+ - ECG200+ - ECG100S - ECG200S CONNECTIVITY, RECEIVING WORK LISTS AND TRANSMITTING ECG EXAMS The type A USB port can be used to transfer data from the electrocardiograph to a USB memory stick inserted in the port (as described in par.10.2.1) and for technical assistance. The mini-USB port can be connected to a computer, as described in Par.10.2.2.

  • Page 67: Standard Network Connectivity (Lan)

    If the device is equipped with WiFi and/or LAN, the electrocardiograph can transmit ECG traces via the network to an external Cardioline ECGWebApp archive system (as described in Par. 7.5). It is also possible to download work lists as described in Par. 8.2. The work lists must be constructed based DICOM attributes conform to the Modality Worklist Information Model of DICOM PS 3.4, Annex K.6.1.2.

  • Page 68: Upgrading Your Device Options

    Activating new options on your device is simple. First of all, you have to contact Cardioline, or your distributor, to purchase the upgrades you need. Be sure you have the serial number of all the devices you need to upgrade, because they are required to finalize the purchase.

  • Page 69: Maintenance And Troubleshooting

    To switch the device off completely, disconnect the power cable and keep the ON/OFF key pressed for 2 seconds. Always perform this operation before proceeding with authorised repairs of the device. 12.3. Regular maintenance Cardioline suggests to regularly check the device:  Perform a functional and operation check daily ...

  • Page 70: Patient Cable Cleaning

    ECG100+ - ECG200+ - ECG100S - ECG200S MAINTENANCE AND TROUBLESHOOTING  Check battery works properly. If you notice anything needing a repair, contact an authorised assistance operator to perform it. 12.3.2. Patient cable cleaning  Before cleaning, remove the cables and terminations. ...

  • Page 71: Operation Check

    ECG100+ - ECG200+ - ECG100S - ECG200S MAINTENANCE AND TROUBLESHOOTING 12.3.4. Operation check After cleaning and checking the device, it is possible to verify the correct operation of the device using an ECG simulator to acquire and print a standard 12-lead ECG of known amplitude. Printing must be clear and uniform on the whole page.
  • Page 72 ECG100+ - ECG200+ - ECG100S - ECG200S MAINTENANCE AND TROUBLESHOOTING 6. Close the battery door with the screw driver. 7. Turn on the device to check if the battery has been replaced correctly. If the device does not turn on, the battery may have been connected in the wrong way. Open the battery door again and repeat the above procedure.

  • Page 73: Cleaning The Thermal Printer

    ECG100+ - ECG200+ - ECG100S - ECG200S MAINTENANCE AND TROUBLESHOOTING NOTE: Refer to section 12.2 for the reference to the approved battery. 12.6. Cleaning the thermal printer Periodically, and anyhow whenever the tracing printing is faulty, the printer and thermal head of the device should be cleaned.

  • Page 74: Messages And Solutions Table

     Door not completely closed Noisy printer Open the door and close it firmly. Verify Cardioline paper is in place.  Non original paper Paper sliding problems Take out paper and position it as  Paper placed incorrectly described in this manual.
  • Page 75 If the problem is not solved try a new patient cable. If the problem still persists contact Cardioline or an Authorized Distributor. Unable to save The system can’t save changes to Try a hardware shutdown. If the problem...
  • Page 76 ECG100+ - ECG200+ - ECG100S - ECG200S MAINTENANCE AND TROUBLESHOOTING Message Cause Solution administrator to check for the correct username and password.

  • Page 77: Technical Specifications

    ECG100+ - ECG200+ - ECG100S - ECG200S TECHNICAL SPECIFICATION TECHNICAL SPECIFICATIONS ECG channels ........12-lead (I, II, III, aVR-L-F, V1-6) CMRR ..........> 100 dB DC input impedance ......No lead-off 100 MΩ A/D converter ........24 bit, 32 kHz Sampling frequency ......

  • Page 78: Filter Features

    ECG100+ - ECG200+ - ECG100S - ECG200S TECHNICAL SPECIFICATION (Glasgow University – Prof. MacFarlane) Adult, Paediatric, STEMI Keyboard ........... Mechanical keypad with alphanumeric keys and special function keys Connectivity ........USB device, LAN (optional) Patient cable ........Standard 15D, 10-wires Data export ........

  • Page 79: Harmonised Standards Applied

    ECG100+ - ECG200+ - ECG100S - ECG200S TECHNICAL SPECIFICATION “A 0,3 mV × s (3 mV for 100 ms) impulse input shall not produce a displacement greater than 0.1 mV outside the region of the impulse.” The acquisition (sampling and filtering) system of the device complies with AHA recommendations (Paul Kligfield et al., Circulation 2007) for both paediatric and adult ECGs.

  • Page 80: Accessories

    Adapters for tab and button electrodes for 4 mm plug, 10 pcs 66010051C Z-FOLD 100X150mm Paper 180 sheets (ECG100) 66010052S Z-FOLD 210x295mm A4 PAPER (ECG200+) 66010053S Z-FOLD 216x280mm LETTER PAPER (ECG200+) 67010223 Carrying case “Cardioline ECG 100” 67040225 ECG200+/s dust cover 67040224 ECG100 dust cover 63090712 ECG100+/S/L trolley II Edition 63090713...

  • Page 81: Warranty

    Cardioline Spa declines all liability for any damage which may be caused, directly or indirectly, to persons or property as a consequence of non-compliance with all the prescriptions specified in the manual, especially warnings regarding installation, safety, use and maintenance of the equipment, as well as non-operation of the equipment.

  • Page 82: Disposal

    ECG100+ - ECG200+ - ECG100S - ECG200S DISPOSAL DISPOSAL Pursuant to Italian Legislative Decree no. 49 dated 14 March 2014 "Implementation of Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE)", the crossed-out "wheeled bin" symbol on the medical device indicates that, at the end of its service life, the product must be collected separately from other wastes.
  • Page 83 ECG100+ - ECG200+ - ECG100S - ECG200S...
  • Page 84 Sales Office: Via F.lli Bronzetti, 8 20129 Milan, Italy T. +39 02 94750470 F. +39 02 94750471 Factory Via Linz, 151 38121 Trento Italy T. +39 0463 850125 F. +39 0463 850088 www.lifelinemedical.net...

This manual is also suitable for:

Ecg200+Ecg100sEcg200s

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