Spengler CARDIOMATE 12 EM-1201 Series User Manual

Electrocardiograph
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CARDIOMATE 12
®
Électrocardiographe
Electrocardiograph
Electrocardiografo
Elektrokardiograph
‫جهاز تخطيط القلب‬
0 1 2 3
Manuel utilisateur
P.4
User Manual
P.52
Manual del usuario
P.99
P.147
Benutzerhandbuch
‫دليل المستخدم‬
P.000
WWW.SPENGLER.FR

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Summary of Contents for Spengler CARDIOMATE 12 EM-1201 Series

  • Page 1 CARDIOMATE 12 ® Électrocardiographe Electrocardiograph Electrocardiografo Elektrokardiograph ‫جهاز تخطيط القلب‬ 0 1 2 3 Manuel utilisateur User Manual P.52 Manual del usuario P.99 P.147 Benutzerhandbuch ‫دليل المستخدم‬ P.000 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

    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 Fragile Batch Number Follow instructions for use www.spengler.fr...
  • Page 7: Product Introduction

    LAN Port 10-Inch 12bit, 1000sps/ 2000sps/ EM-1201B color LCD 432x334x76 without LAN ≤80 channel channel display Port 10-Inch 12bit, 1000sps/ 2000sps/ EM-1201A color LCD 432x334x76 with channel channel display LAN Port 2.3 Product Details 2.3.1 Top Panel www.spengler.fr...
  • Page 8: Bottom Panel

    The rated voltage and the rated capacity of the battery pack are as follows : Rated Voltage:14.4V; Rated Capacity : 5200mAh 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. www.spengler.fr...
  • Page 9: Right Panel

    Read the SD card USB Socket Standard USB socket, connecting to a U disk USB Socket Master USB socket, connecting to a PC to realize data exchange Net cable port Standard net port, connecting to a PC (optional) 2.3.5 Keyboard Function www.spengler.fr...
  • Page 10: 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 11: 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 12 1) Press the button indicated in Figure A to open the recorder casing (as shown in Figure B); 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 13 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 14: 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 15: 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 16: Acquisition And Print Ecg Report

    ECG acquisition time less than 10s and the ECG waveform can be frozen up to 300seconds. 【 】 Lead Press function key to enter the Lead interface 【 】 Setup Press function key to enter the system settinginterface 【 】 More Press function key to go to the next page www.spengler.fr...
  • Page 17: 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 18 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 19 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 20: 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 21: Ecg Acquisition

    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 Manual12 Twelve-channel mode. Record ECG data of twelve leads simultaneously www.spengler.fr...
  • Page 22: 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 23: 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 24 12*1 print format Simple mode: print waveform of 12 * 1 format. The print time can be set and only the interpretations will be printed. Print time Not suitable for roll paper printing of simple mode of 12 * 1 format www.spengler.fr...
  • Page 25: 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 26: Communication Setup

    In the Setup interface, press button【3】to enter the Communication Setup, as shown below: The corresponding setting interface can be accessed through the digital key. The premise of successful communication setting is that the ECG must be connected to the Internet. www.spengler.fr...
  • Page 27: 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 28 80 bpm), and the word “demo” is displayed on the screen. Data mode In this mode, real-time signals cannot be obtained. Calibration waveform is displayed in the interface (1mv square Calibration wave). In this mode, real-time signals can not be obtained. www.spengler.fr...
  • Page 29: 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 30: 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 required lead system through 【 】and 【 】 button. The lead systems areas follows: www.spengler.fr...
  • Page 31: 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 32: System Check

    System check interface. 6. File Management On the second page of the main interface, press File【F2】to enter the file management interface. Patient records can be edited, printed, queried, previewed, deleted, and uploaded here. www.spengler.fr...
  • Page 33: Upload Report

    Note: The import file format must be the format supported by the equipment, otherwise the import will fail. F7more Press F7 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 34: 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 35: 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 36: 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 37: 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 38 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 39: 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 40: 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 41: 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 42: 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 43: Appendix B: Technical Specifications

    10/5 mm/mV, 20/10 mm/mV, AGC. Tolerance ±2% 2000 sps/channel (EM-1201/ EM-1201B) Sampling Rate 32000sps/channel (EM-1201A) Storage rate 1000sps/channel ~ Amplitude : ±2mV ±700mV Pacemaker pulse detection ~ duration time : 0.1 ms 2.0 ms 4.563 uV/LSB (EM-1201/ EM-1201B) Amplitude quantisation 2.289 uV/LSB (EM-1201A) www.spengler.fr...
  • Page 44: Function Features

    2. It can be connected to external USB printer to print ECG report on A4 Print paper. 3. It supports print ECG grid on paper without grids. 3. Recorder Recorder : Thermal Dot-matrix Recorder ≥ 8 dots/mm (vertical direction) ≥ 40 dots/mm (25mm/s); ≥ 20 dots/mm (50 mm/s) (horizontal Resolution direction) www.spengler.fr...
  • Page 45: Device Classification

    4.2 kg Gross weight 7.5 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 46: 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 47: 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 48: 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...

This manual is also suitable for:

Cardiomate 12 em-1201Cardiomate 12 em-1201bCardiomate 12 em-1201a

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