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Spengler CARDIOMATE 3 User Manual

Electrocardiograph

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CARDIOMATE 3
& CARDIOMATE 6
Électrocardiographe
Electrocardiograph
Electrocardiografo
Elektrokardiograph
‫جهاز تخطيط القلب‬
®
®
Manuel utilisateur
User Manual
Manual del usuario
Benutzerhandbuch
‫دليل املستخدم‬
WWW.SPENGLER.FR
0 1 2 3
P.4
P.52
P.100
P.148
P.194

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Summary of Contents for Spengler CARDIOMATE 3

  • Page 1 CARDIOMATE 3 ® & CARDIOMATE 6 ® Électrocardiographe Electrocardiograph Electrocardiografo Elektrokardiograph ‫جهاز تخطيط القلب‬ 0 1 2 3 Manuel utilisateur User Manual P.52 Manual del usuario P.100 Benutzerhandbuch P.148 ‫دليل املستخدم‬ P.194 WWW.SPENGLER.FR...
  • Page 2 Damage not caused by non-human factors or force majeure factors such as typhoons and earthquakes. 0 1 2 3 SPENGLER SAS 30 rue Jean de Guiramand - 13290 Aix en Provence - France Shenzhen ECGMAC Medical Electronics Co., Ltd. 2nd Floor of Block 2, Haoye Industrial Park, Tiegang Road, Xixiang Street, Baoan District,...
  • Page 3: Table Of Contents

    Useful Life & Date of Manufacture Appendix A Package and Accessories Appendix B Technical Specifications Appendix C Key Components Appendix D List of Functional Accessories Appendix E EMC Information Appendix F Manufacturer Information Appendix G European Authorized Representative Information www.spengler.fr...
  • Page 4: Safety Guidance

    In this condition, the safety of instrument operation can not be guaranteed. When the patient is equipped with pacemaker, it may influence the accuracy and results of the ECG examination. It is recommended that the doctor combines the waveform to www.spengler.fr...
  • Page 5: Warnings And Cautions

    To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Do not place ME equipment where it is difficult to operate the disconnect device. 1.3 Warnings and Cautions None www.spengler.fr...
  • Page 6: Lithium Battery Care Warnings

    Battery indicator know to avoid possible damage to patients or operators. Caution signs: Information you should know about how to Equipotentiality avoid possible damage to your equipment. Humidity range of transportation Atmospheric pressure range for transportation and and storage storage www.spengler.fr...
  • Page 7: Product Introduction

    LCD display LAN Port 12bit, 1000sps/ 2000sps/ 7-inch color ≤ EM-601B 310 244 65 without LAN channel channel LCD display Port 12bit, 1000sps/ 32000sps/ 7-inch color EM-601A 310 244 65 with channel channel LCD display LAN Port www.spengler.fr...
  • Page 8: Product Details

    Do not place heavy objects on the LCD screen or hit the LCD screen, otherwise, it will be damaged. When the equipment is not in use, put the display back to its original position to prevent accidental damage. 2.3.2 Bottom Panel www.spengler.fr...
  • Page 9: Right Panel

    If the lithium battery is not used for a long time (more than two to three months), the user shouldfirst charge the battery when using it again. 2.3.3 Rear Panel Indicator Name Function Power Supply Sock- Connected to power adapter Heat Emission Hole Path for internal heat emission Handle Portable 2.3.4 Right Panel www.spengler.fr...
  • Page 10: Keyboard Function

    Conductor other grounding wires or installed grounding wires 2.3.5 Keyboard Function Indica- Name Function Alphanumeric Input digit, letter and symbols keyboard Cancel operation Function Key Select menu functions on the screen Delete Delete characters www.spengler.fr...
  • Page 11: Patient Cable Socket And Definition For Plug Pins

    2.4 Patient Cable Socket and Definition for Plug Pins 2.4.1 Patient Cable Socket : Applied part of type CF with defibrillator proof 2.4.2 Definitions of Corresponding Pins Signal Signal Signal C2(Input) F(Input) C3(Input) C4(Input) C1(Input) C5(Input) R(Input) C6(Input) L(Input) N or RF(Input) www.spengler.fr...
  • Page 12: Patient Cable & Electrodes

    Make sure that there is no intense electromagnetic interference source around the equipment, such as electrosurgical equipment, ultrasound instruments, radiographs, etc. Turn off the equipment if necessary. The temperature must be kept between 5 ºC and 40 ºC during operation while humidity less than or equal to 80%. www.spengler.fr...
  • Page 13 1) Press the button indicated in Figure A to open the recorder case. Figure A Figure B 2) Take out the paper roller, as shown in the figure below and then put the paper through the roller with the grid side of the paper facing the thermal print head; www.spengler.fr...
  • Page 14 Do not use water pipes or other pipes as the earth wire, otherwise the first-level safety measures of the equipment are invalid and patients may be at risk of electric shock. www.spengler.fr...
  • Page 15: Preparing The Patients

    3.3 Connect the Patient Cable The Patient Cable will be used as applied parts specified. As shown below, connect the patient cable to the patient cable socket on the right side of the main unit, and then screw it. Patient cables www.spengler.fr...
  • Page 16: Connect The Electrodes

    Right leg/Upper leg as close to torso as possible N or RF Black Green Left leg/Upper leg as close to torso as possible Green Chest 1 Chest 2 Yellow Yellow Chest 3 Green Green Chest 4 Brown Blue Chest 5 Black Orange Chest 6 Purple Purple www.spengler.fr...
  • Page 17: Acquisition And Print Ecg Report

    ECG waveform. However, the freeze function Freeze would not available if ECG acquisition time less than 10s and the ECG waveform can be frozen up to 300seconds. 【F5】 More Press function key to go to the next page www.spengler.fr...
  • Page 18: Input Patient Information

    The default way of ID input is via time collection and it can be changed in system setting. Attention : The ID, Name, Inpatient No, Outpatient No, Technician and Physician should less than or equal to 63 ASCII characters. www.spengler.fr...
  • Page 19 Caution : if the barcode is set correctly, but only ID can be scanned, please try to scan the barcode of the «enter» key in the manual with the scanner, and then try to scan the barcode again. www.spengler.fr...
  • Page 20 Date range : Query the patient information of the set date range Query the server information according to the selected update time range, and return to Confirm F1 check the query results when the server is set correctly. Cancel F2 Cancel query and return. No results www.spengler.fr...
  • Page 21: Check The Quality Of The Ecg

    Note : If lead-off alarm appears during the acquisition, please re-sample. The data acquired in the case of lead off may lead to information loss, leading to missed diagnosis or misdiagnosis. www.spengler.fr...
  • Page 22: Ecg Acquisition

    Single channel mode. Record ECG data of single lead Manual2 Two-channel mode. Record ECG data of two leads simultaneously Manual3 Three-channel mode. Record ECG data of three leads simultaneously Manual6 Six-channel mode. Record ECG data of six leads simultaneously www.spengler.fr...
  • Page 23: Reanalysis

    Move the calibration line left and right according to the set steps 4.6 Print ECG Report This equipment supports two print methods: thermal printer and USB printer. You can select the appropriate printing method in the print setup interface. www.spengler.fr...
  • Page 24: Setup

    Restore factory settings/Default F2: Restore the related parameters of the machine to the factory default state. 5.1 Print Setup Press button【1】to enter print setup interface in the system setting interface. Use 【▲】 and【▼】button to select Printer. The interface is shown as the figure below: www.spengler.fr...
  • Page 25 2 min, and Duration is set to 24 min, after pressing the START/STOP key, the print will be performed every two minutes and come to 12 times. Duration Set the duration of periodic sample Interval Set the interval of periodic sample www.spengler.fr...
  • Page 26: Analysis Setup

    In the System Setting interface, press button【2】to enter the Analysis Setup, as shown below: Measurement information will be showed in the printout or files when the ECG measure- ment is enabled. The measurement information includes: HR---Heart Rate PR interval ECG Measurement QRS complex duration QT/QTC P/QRS/T RV5/SV1 RV5+SV1 www.spengler.fr...
  • Page 27: Communication Setup

    To access the HL7 server, the HL7 server of the ECG must be set. The specific HL7 setup settings are based on the HL7 server. To access the WORKLIST server, the WORKLIST server of the ECG must be set, WORKLIST setup and the specific settings are based on the WORKLIST server. www.spengler.fr...
  • Page 28: Information Setup

    5.5 Admin Configuration In the Setup interface, press button 【5】on the keyboard and then the password input prompt box will pop out. Input the password (default password 123456) and then press 【F1】to enter the admin configurations, as shown below: www.spengler.fr...
  • Page 29 Cancel the settings and exit the Admin Configuration Change P Change Admin Configuration password Sys check Enter the system diagnosis to self-check the hardware of the ECG, see 5.10 for details More F5 Function button for switching to the next page of the Admin Configuration www.spengler.fr...
  • Page 30: Filter Setup

    Baseline Filter OFF, 0.05 Hz, 0.16 Hz, 0.25 Hz, 0.32 Hz, 0.5 Hz, 0.67 Hz EMG Filter OFF, 20 Hz, 25 Hz, 30 Hz, 35 Hz, 40 Hz, 45 Hz Low pass Filter OFF, 75 Hz, 100 Hz, 150 Hz www.spengler.fr...
  • Page 31: Time And Date Setup

    In the Setup interface, press button【8】to enter the Lead Selection Setup, the users can set the rhythm lead and lead system, as shown below:below: There are 8 lead setup systems available for selection. Users can select one according to their needs. www.spengler.fr...
  • Page 32: Others

    All : 5 mm/s, 6.25 mm/s, 10 mm/s, 12.5 mm/s, 25 mm/s and 50 mm/s Switch the gain in the main interface Normal : 5 mm/mV, 10 mm/mV, 20 mm/mV; Gain All : 1.25 mm/mV, 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 40 mm/mV, 10/5 mm/ mV, 20/10 mm/mV, AGC www.spengler.fr...
  • Page 33: System Check

    Press 【Enter】 to enter the test item. After the test, press the 【ESC】 to exit the current test item interface and return to the System check interface. 6. File Management On the second page of the main interface, press File【F3】to enter the file management interface. Patient records can edited, printed, queried, previewed, deleted, and uploaded here. www.spengler.fr...
  • Page 34: Upload Report

    Note: The import file format must be the format supported by the equipment, otherwise the import will fail. More F5 Press F5 to show more function keys. 6.1 Upload Report The report can be uploaded through FTP, shared directory, DICOM and other protocols. www.spengler.fr...
  • Page 35: Data Exchange With External Storage

    When importing data, users must ensure that the external storage is effectively connected to the ECG machine, otherwise the import failure may occur. Users must insert a USB flash disk or SD card before entering file management, otherwise the import may fail. www.spengler.fr...
  • Page 36: Check Ecg Files On Pc

    ECG data management software to set the import path as the path of the ECG data. Select the ECG data to be imported and click confirm, then the ECG data is successfully imported to the ECG data management software. www.spengler.fr...
  • Page 37: Cleaning, Care And Maintenance

    (75%). For stubborn stain, soak it with a little alcohol (75%) first and wipe it off with a clean soft cloth. After air dried, install the recorder paper and close the recorder casing. www.spengler.fr...
  • Page 38: Disinfection

    LCD screen, as follow: Full capacity Capacity is adequate. Capacity is low and needed to be charged. Capacity is insufficient and needed to be charged. Capacity is exhausted and needed to be charged immediately. www.spengler.fr...
  • Page 39 Check whether the patient cables are in good contact according to the following table. The resistance between each lead from the electrode plug to the corresponding pin in the lead wire plug is less than 10 Ω. • Note: The resistance of the patient cable with defibrillation-proof is approx.10 KΩ. www.spengler.fr...
  • Page 40: Troubleshooting

    If the problem still exists, please contact our after- sales service department or designated repair unit. 8.3 AC Interference • In the ECG recording process, there is a certain range of regular interference. There is obvious ECG baseline jitter, as shown in the following ECG waveform. www.spengler.fr...
  • Page 41: Emg Interference

    • Are the electrodes and patient skin clean? • Is gel applied to the skin where electrodes placed? • Is it caused by movement or breathing of the patient? • Are the old electrodes mixed with the new ones? www.spengler.fr...
  • Page 42: Save Ecg Data Without Printing

    For software upgrades, please consult the manufacturer directly. Note: Spengler‘s obligations under this warranty do not include freight and other expenses. All costs of repairing products beyond the warranty period shall be borne by the user. All maintenance and treatment shall be carried out by engineer and technical personnel approved by ECGMAC.
  • Page 43: After-Sale Service

    If you have any question about maintenance, technical specifications or malfunctions of devices, please contac: - the distributor: SPENGLER SAS - 30 rue Jean de Guiramand - 13290 Aix-en-Provence - FRANCE - or manufacturer: Shenzhen ECGMAC Medical Electronics Co., Ltd...
  • Page 44: Appendix B: Technical Specifications

    1.25 mm/mV、2.5 mm/mV、5 mm/mV、10 mm/mV、20 mm/mV、40 mm/ Gain mV、10/5 mm/mV、20/10 mm/mV、AGC. Tolerance ±2% 2000 sps/channel (EM-301/ EM-301B/ EM-601/ EM-601B) Sampling Rate 32000sps/channel(EM-301A/ EM-601A) 1000sps/channel Storage rate Amplitude:±2mV~±700mV Pacemaker pulse detection duration time:0.1 ms~2.0 ms 4.563 uV/LSB(EM-301/ EM-301B/ EM-601/ EM-601B) Amplitude quantisation 2.289 uV/LSB(EM-301A/ EM-601A) www.spengler.fr...
  • Page 45: Function Features

    2. It can be connected to designated external USB printer to print ECG re- Print port on A4 paper. 3. It supports print ECG grid on paper without grids. 3. Recorder Recorder : Thermal Dot-matrix Recorder ≥ 8 dots/mm (vertical direction) Resolution ≥40 dots/mm (25mm/s); ≥ 20 dots/mm (50 mm/s) (horizontal direction) www.spengler.fr...
  • Page 46: Device Classification

    2.0 kg Gross weight : 4.5 kg B.3 Environment Condition 1. Transportation Temperature -20℃~+55℃ Relative Humidity ≤93% Atmospheric Pressure 50kPa~106kPa 2. Storage Temperature -20℃~+55℃ Relative Humidity ≤93% Atmospheric Pressure 50kPa~106kPa 3. Working Temperature +5℃~+40℃ Relative Humidity ≤80% Atmospheric Pressure 86kPa~106kPa www.spengler.fr...
  • Page 47: Appendix C: Key Components

    ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE). www.spengler.fr...
  • Page 48: Technical Description

    10 V/m IEC61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz 80 % AM at 1 kHz 80 % AM at 1 kHz NOTE UT is the a.c. mians voltage prior to application of the test level. www.spengler.fr...
  • Page 49: Appendix F: Manufacturer Information

    Email : info@ecgmac.com Appendix G: European Authorized Representative Information Company Name: Well Kang Ltd Company Address: Entreprise Hub, NW Business Complex, 1 Beraghmore Rd, Derry, BTS48 8SE, Northern Ireland, UK Tel: +44(20)3287 6300, +44(33)3303 1126 Fax: +44(20)7681 1874 Web: www.wellkang.ltd.uk, www.CE-marking.eu www.spengler.fr...
  • Page 50 Date de 1 marquage CE : 19/01/2012 CE marking date: 2012/01/19...