Cardioline ECG100L User Manual
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Cardioline ECG100L User Manual

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ECG100L
User manual
Rev.01 – 22.09.2017
1936

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Summary of Contents for Cardioline ECG100L

  • Page 1 ECG100L User manual Rev.01 – 22.09.2017 1936...
  • Page 2 ECG100L 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 Cardioline Spa Via Linz, 19-20-21...

  • Page 3: Table Of Contents

    Guidance and Manufacturer's declaration - Electromagnetic immunity .........10 3.3. Guidance and Manufacturer's declaration - Electromagnetic immunity .........11 3.4. Recommended separation distances between portable and mobile RF communications equipment and the ECG100L ........................12 SYMBOLS AND LABEL ..........................15 4.1. Explanation of the symbols ......................15 4.2.
  • Page 4 ECG100L 7.3. Viewing the ECG ..........................30 7.3.1. Disconnection of the leads .......................31 7.4. Acquiring an ECG ..........................31 7.4.1. Automatic acquisition of an ECG (AUTO) .................32 7.4.2. Manual acquisition of an ECG (MANUAL) ................33 7.4.3. Acquisition of an urgent ECG ....................34 7.5.
  • Page 5 ECG100L 10.7. Troubleshooting table ........................47 10.8. Error notifications ..........................48 11. TECHNICAL SPECIFICATIONS ........................51 11.1. Harmonised standards applied ......................52 11.2. Accessories............................53 12. WARRANTY ..............................55 13. DISPOSAL ..............................56...
  • Page 6 ECG100L...

  • 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 ECG100L GENERAL INFORMATION...

  • Page 9: 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 10 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 11.2 for the list approved accessories. ...
  • Page 11  The internal rechargeable battery is hermetically sealed NiMH and requires no maintenance. Should the battery be faulty, contact Cardioline 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 12 ECG100L SAFETY INFORMATION  The device and the patient cable should be cleaned before use. Check the connections for any damage or excessive wear before each use. Replace the patient cable should it present any damage or be excessively worn.
  • Page 13 ECG100L SAFETY INFORMATION  Power Supply has the following characteristics:  Model: AFM60US18  Manufacturer: XP Power Limited  Rated Input: 100-240 VAC, 50-60 Hz, 1.5-0.9 A  Rated Output: 60 W, 18 V, 3.34 A  Protection Class: I ...
  • Page 14 ECG100L SAFETY INFORMATION...

  • 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

    3.2. Guidance and Manufacturer's declaration - Electromagnetic immunity The ECG100L is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG100L assure that it is used in such an environment. Immunity test Conformity...

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

    3.3. Guidance and Manufacturer's declaration - Electromagnetic immunity The ECG100L is intended for use in the electromagnetic environment specified below. The customer or the user of the ECG100L should assure that it is used in such an environment. Emission test...

  • Page 18: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Ecg100L

    If the measured field strength in the location in which the ECG100L is used exceeds the applicable RF compliance level above, the ECG100L should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ECG100L.
  • Page 19 ECG100L ELECTROMAGNETIC COMPABILITY (EMC) For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 20 ECG100L ELECTROMAGNETIC COMPABILITY (EMC)

  • Page 21: Symbols And Label

    ECG100L 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...

  • Page 22: Device Label

    ECG100L SYMBOLS AND LABEL 4.2. Device label ECG100L...

  • Page 23: Introduction

    USB, print the 12 lead ECG in automatic or manual mode by means of its built-in thermal printer. ECG100L is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.

  • Page 24: Description Of The Device

    ECG100L is characterized by a useful 5” colour touchscreen display, from which all operations can be easily performed. A smart user interface guides the user through the different steps necessary to acquire the electrocardiogram.

  • Page 25: General Overview

    ECG100L INTRODUCTION 5.4.1. General overview Front view: Display Thermal printer Physical Keys Rear view: Power supply...
  • Page 26 ECG100L INTRODUCTION Side view: Patient cable input Display and hardware keys: Display On/Off switch Physical Keys...

  • Page 27: Keyboard

    Physical keys Physical Keys ECG100L has five physical keys that, depending on the duration of the pressure, will activate the primary function or the secondary feature, with the exception of the power button. The user shall keep the key pressed for more than 1s to trigger the secondary function. Below are the available functions: Description Turns on/off the device.

  • Page 28: Display

    ECG100L INTRODUCTION 5.4.3. Display ECG100L is supplied with a 5” Backlit LCD display with Resistive Touch Panel. When acquiring an ECG tracing, the display shows the following main information:  Surname, Name: surname and name of the patient being examined, if entered.

  • Page 29: 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 30: Loading The Paper

    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.

  • Page 31: Power Connection

    6.4. Power connection ECG100L can also be powered by battery, disconnected from the mains. The first time it is used, charge the battery completely, connecting the electrocardiograph to the power supply. Make sure that the power supply is connected to an earthed electrical socket.

  • Page 32: Battery Operation

    ECG100L 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. The device switches off automatically when the battery reaches the minimum allowed level. When the device detects that the battery voltage has discharged almost to this point, the message "Battery depleted"...

  • Page 33: Execution Of An Exam

    ECG100L 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 34: Connecting The Patient

    ECG100L 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.
  • Page 35 ECG100L 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.

  • Page 36: Viewing The Ecg

    ECG100L EXECUTION OF AN EXAM 7.3. Viewing the ECG The electrocardiograph starting screen is the real time with torso screen and lead fail indications. Real time display Display 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 37: Disconnection Of The Leads

    Message area Real time display with warning message. NOTE: To set up the Cabrera format contact the Cardioline service. 7.3.1. Disconnection of the leads If one or more electrodes are disconnected the message “Lead fail” is displayed over the traces. The device draws the Torso screen and the lead in fail is marked with a red dot.

  • Page 38: Automatic Acquisition Of An Ecg (Auto)

    ECG100L EXECUTION OF AN EXAM 7.4.1. Automatic acquisition of an ECG (AUTO) When the operator presses the AUTO button, if the device has the patient demographics already loaded, it prompts the user to confirm whether to continue with the current patient or start with a new one.

  • Page 39: Manual Acquisition Of An Ecg (Manual)

    ECG100L EXECUTION OF AN EXAM  Filter Selects the low-pass filter to apply to the of the the displayed and printed traces (off, 40, 25 Hz).  Print Prints the ECG with the current settings.  Save Saves the acquired ECG in the internal memory.

  • Page 40: Acquisition Of An Urgent Ecg

    Stops the manual printout and restores the real time display screen. 7.4.3. Acquisition of an urgent ECG ECG100L provides a way to acquire urgent ECG, skipping the patient data entry proposed during the AUTO acquisition. Urgent (STAT) ECG can be acquired by keeping the AUTO key pressed for 2 seconds.

  • Page 41: Automatic Printing Formats

    ECG100L EXECUTION OF AN EXAM 7.5.1. Automatic Printing formats Format ECG data 5 seconds of 6 leads in 6 channel format. 2.5 seconds of 12 leads in 3 channel format. 3x4+1 2.5 seconds of 12 leads in 3 channel format; the fourth channel is a rhythm strip of 10 second lead defined by the user (Rhythm Lead).
  • Page 42 ECG100L EXECUTION OF AN EXAM The screen will show a USB icon indicating that the device is connected via USB. When the device is disconnected, a message tells you to restart the device to re-enable the features. When this screen is on, no keys on the device is active.

  • Page 43: Device Settings

    ECG100L DEVICE SETTINGS DEVICE SETTINGS 8.1. 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 soft keys on the display.

  • Page 44: System Settings

    ECG100L DEVICE SETTINGS 8.3. System settings The system settings page allows the user to choose the following parameters: Field Description Possible values Language User interface Language Date format Format of the date DMY (Default)/MDY/YMD AC Filter AC filter 50Hz/60Hz/Off (Stored in the SCP record of the exam in...

  • Page 45: Rhythm Leads Setting

    ECG100L DEVICE SETTINGS 8.4. Rhythm Leads setting The rhythm leads page allows the user to define rhythm leads for AUTO printout layouts 3x4+1 and 3x4+3: Field Description Possible values LEAD 1 Default II I, II, III, aVR, aVL, aVF, V1, V2, V3, V4,...

  • Page 46: Memory Wipe

    ECG100L DEVICE SETTINGS 8.5.1. Memory wipe To wipe the internal memory of the device, select the Service settings page and then press Wipe memory. After having deleted all the ECGs, the device will reboot. 8.5.2. Display calibration The touchscreen can be recalibrated pressing the Reset calibration key in the Service settings page.

  • Page 47: 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 48 ECG100L UPGRADING YOUR DEVICE OPTIONS...

  • Page 49: Maintenance And Troubleshooting

    To switch the device off completely, disconnect the power cable and keep the ON/OFF key pressed. Always perform this operation before proceeding with authorised repairs of the device. 10.3. Regular maintenance Cardioline suggests to regularly check the device:  Perform a functional and operation check daily ...

  • Page 50: Patient Cable Cleaning

    ECG100L MAINTENANCE AND TROUBLESHOOTING  Check that the keys and controls work properly and have an appropriate aspect.  Check battery works properly. If you notice anything needing a repair, contact an authorised assistance operator to perform it. 10.3.2. Patient cable cleaning ...

  • Page 51: Recommendations

    ECG100L MAINTENANCE AND TROUBLESHOOTING 10.4. Recommendations Ensuing any type of assistance on the device or should you suspect non-conforming operation, we recommend the following procedures:  Check that it works properly.  Perform the checks to guarantee a continuous electrical safety of the device: ...
  • Page 52 ECG100L MAINTENANCE AND TROUBLESHOOTING 1. Open the battery door with a screw driver. 2. Disconnect the battery connector. 3. Connect the new battery. 4. Place the battery in its compartment. It is recommended to plug the device in when possible to charge the battery to a maximum.

  • Page 53: Cleaning The Thermal Printer

    ECG100L MAINTENANCE AND TROUBLESHOOTING 10.6. Cleaning the thermal printer Periodically, and anyhow whenever the tracing printing is faulty, the printer and thermal head of the device should be cleaned. 10.6.1. Cleaning the printer  Unplug the electrocardiograph.  Clean the outside surface of the unit with a moist cloth and a water and neutral detergent solution.

  • Page 54: Error Notifications

    10.8. Error notifications ECG100L will display on a popup message error/warning conditions requiring the intervention of the operator as described below. The popup message may appear in any screen, consistently with the function performed in the screen; the error reported in the popup message may be acknowledged by the operator and thus closed, or it may automatically close if the condition resolves.
  • Page 55 ECG100L MAINTENANCE AND TROUBLESHOOTING Message Cause Solution the battery is depleted. Unable to export The device does not export the Try to disconnect and reconnect the USB Key. exams to USB flash drive. If the error remains try a different USB key.
  • Page 56 ECG100L MAINTENANCE AND TROUBLESHOOTING...

  • Page 57: Technical Specifications

    ECG100L 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 ........16 bit, 32 kHz Sampling frequency ......500Hz A/D conversion ........16 bit Output data resolution ......

  • Page 58: Harmonised Standards Applied

    ECG100L TECHNICAL SPECIFICATION Connectivity ........USB device Patient cable ........Standard 15D, 10-wires Data export ........SCP (standard format). PDF and other formats via external PC software Power supply ........Medical grade AC power supply (100-240 VAC 50/60 Hz); internal rechargeable battery (NiMH) Internal battery .........

  • Page 59: Accessories

    ECG100L TECHNICAL SPECIFICATION STANDARD DESCRIPTION 62304:2006/AC:2008 EN 62366:2008 Medical devices - Application of usability engineering to medical devices 11.2. Accessories CODE DESCRIPTION 63030105 4 Peripheral ECG electrodes clamp AG/ agcl 63030106 Set of 4 peripheral ECG electric clamp Ag/Agl 63030107...
  • Page 60 ECG100L TECHNICAL SPECIFICATION...

  • Page 61: 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 62: Disposal

    ECG100L 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 63 ECG100L...
  • Page 64 Sales Office Via F.lli Bronzetti, 8 20129 Milan, Italy T. +39 02 94750470 F. +39 02 94750471 Factory Via Linz, 19-20-21 Spini di Gardolo 38121 Trento Italy T. +39 0463 850125 F. +39 0463 850088...

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