Beam ECG Operating Manual
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Beam ECG Operating Manual

Loop-/ event recorder
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Operating Manual
ECG Loop-/ Event Recorder
0044
ECG e-health Loop/Event
Analysis Unit:
Hypertension Management Software
Client-Server
(HMS CS) Version 4.6 and higher
Vendor:
EN

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  • Page 1 Operating Manual ECG Loop-/ Event Recorder 0044 ECG e-health Loop/Event Analysis Unit: Hypertension Management Software Client-Server (HMS CS) Version 4.6 and higher Vendor:...
  • Page 2 © ® Copyright Beam Revision 4.6.1 01/2016 I.E.M. GmbH all rights reserved. The content may not be duplicated or published without the prior written consent of I.E.M. GmbH. Manufacturer: I.E.M. Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft GmbH Cockerillstraße 69 52222 Stolberg...

  • Page 3: Table Of Contents

    4.4 Setup of User Interface HMS CS ........... 24 4.4.1 Menu Bar ..................24 4.4.2 Taskbar ..................... 26 4.4.3 Using the Mouse ................27 4.5 First steps with a sample patient..........27 4.5.1 Show Sample Patient ............... 27 Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...
  • Page 4 Set filter and zoom ................45 4.10.2 Show and hide conductions ............. 46 4.10.3 R-R Interval-Detection ..............46 4.10.4 Measuring the ECG using the mouse pointer ........46 4.10.5 Add comments ................. 47 4.10.6 Print ....................49 4.11 e-health .................. 50 4.11.1...
  • Page 5 7. Warranty and Repair Terms ..........8. Appendix 8.1 EMC Guidelines and Manufacturer Statement ...... 71 8.2 Important Notes for the Patient ..........74 8.3 Accessories Order list ECG Recorder Beam ....... 75 ® Beam ® , Operating Manual, Rev. 4.6.1 01/2016,...

  • Page 7: Introduction

    1.2 About this Operating Manual This operating manual will make you quickly familiar with the use of the ECG Loop-/ Event Recorder and its accessories. After a little practicing you will learn how easily ®...

  • Page 8: Scope Of Delivery

    3-channel ECG Loop-/ Event Recorder ® 2. Bag for the Beam 3-channel ECG Loop-/Event Recorder 3. 2 AAA alkaline batteries 4. Electrode Cables 5. HMS Client-Server on CD 6. Operating Manual Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 9: Directions For Use

    Infrequently (Not daily) occurring palpitations, mild dizziness, mild faintness, car- diac presyncopes, cardiac syncopes with longer lasting aura. These indications are the same as for the execution of a long term-ECG but the diagnostic accuracy is significantly higher for symptoms not occurring everyday due to the longer operating time of the ECG Loop-/Event Recorders.

  • Page 10: Important Notes For The Patient

    Handle the connection with care - the plug should slide without too much pressure into the port. ■ In the normal operating mode the ECG Recorder flashes green every 2 Seconds. If an error occurs the recorder will issue audible signals.

  • Page 11: Product Description

    The ECG Loop-/Event Recorder is prepared and read by the analysis unit HMS CS. Using the HMS CS, saved recordings can be transferred to a PC and be displayed on the monitor in different forms as graphics and can be printed.

  • Page 12: The Start Button

    If possible the Loop-/Event-function of the Beam should be used with the electrode ® cable in order to record the ECG in the Loop mode immediately before pressing the start button. The cable has 4 pushbuttons for the standard single-use electrodes for the European system: Code 1 (Europe) Beam ®...

  • Page 13: The Bluetooth-Interface

    The advantages of this method are, that a ECG documentation is not only possible from activation onwards, but also beforehand improving ECG quality, which facilitates the interpretation.

  • Page 14: Recording Preparation

    3. Product Description The ECG Recorder Beam recognises if a single-use electrode cable is connected and activates then the Loop or Event recording automatically. 3.5 Recording Preparation ■ Use the electrode cable with single-use electrodes if possible. The Beam ®...
  • Page 15 ■ After the preparation of the patient the control recording is carried out (training). The ECG recording can be transferred in real-time to the HMS CS via Bluetooth. Patient and staff receive an immediate overview of the correct positioning of the electrodes on the chest wall.

  • Page 16: E-Health Preparation

    I.E.M. GmbH company. Figure 3.3 E-Health Data Transfer The ECG Loop-/Event Recorder and the portable radio have to be connected once via Bluetooth. If this has not been done by the vendor or by I.E.M. GmbH, the fol- lowing steps have to be carried out: ■...

  • Page 17: Technical Data

    A/D Resolution: 12 Bit Input Impedance: 9 MΩ Sensitivity: 5 mV Event Case Electrodes: 4 Ag/AgCl on the reverse of the Beam ® Loop/Event cable single- cable connector for 4 standard single-use electrodes use electrodes: Ag/AgCl Event Period: adjustable (15 sec to 3 min)

  • Page 18: Symbols

    Meaning: Warning, please read accompanying documenta- tion. Manufacturing Date Meaning: Date of production CE Sign Meaning: The device meets the basic requirements of the European Medical Devices Directive. Bluetooth-Label Meaning: Bluetooth-Interface integrated. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 19: Hypertension-Management-Software Client-Server

    4. Hypertension-Management-Software Client-Server ® The ECG is recorded and saved upon pressing the button. After each recording the ECG can, depending on the settings, be transmitted telemetrically to the physician and/or be analyzed in the practice. The HMS CS (from Version 3.0) configures the recorder, manages the patient data and displays the ECG recordings.

  • Page 20: Install Software

    2) Select Patient or create new 3) Connect recorder with HMS CS 4) Prepare recorder 5) End HMS CS. ■ After receipt of the ECG recording: 1) Start HMS CS 2) Connect recorder with HMS CS 3) Read measured values from recorder 4) Analyse measured data 5) End HMS CS.

  • Page 21: Installation For Windows

    □ open the CD-ROM-drive in Windows Explorer and □ click on the file CD_Start.exe in order to start the installation. ► Select your language. ► In the installation menu click on HMS CS Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 22: Installation For Macintosh ® Os 10.4 And Newer

    ► Put the provided CD into your CD-ROM driver. The CD symbol for HMS CS appears on the screen. ► Double-click this CD symbol for HMS CS. The CD-ROM will open. ► Open the directory Mac_10-4. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 23: Installation For Linux

    ► In the the upper area of the work windows click in the task bar on If you changed a file before you will be asked if you want to save data. Information about the progress of the completion appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 24: Setup Of User Interface Hms Cs

    (Warning: By restoring the database the existing data will be replaced with the – saved database – danger of data loss.) Audit trail Record of all changes made in patient data Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...
  • Page 25 Specify settings for analysis Colours Specify colours for curves and background for dia- grams Options Specify calculations, display and Bluetooth GDT settings Specify file and directory settings for the GDT import/ export Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 26: Taskbar

    Close Program End HMS CS. Practice Receive series of measurements via the practice Monitoring monitoring Note: Some of these functions can also be selected via menu items in the menu bar. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 27: Using The Mouse

    The working window and the window Patient List appear. 4.5.1 Show Sample Patient ► Click on the Doe John row and then on Tip: It’s quicker to just double-click the row. Patient information is displayed in the working window. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 28: Display Measured Data Of The Sample Patient

    4.5.2 Display measured data of the sample patient ► Click on the ECG tab. The ECG tab contains a list of already performed measurements on the left side. ► Click on the measurement. The belonging measured value table is displayed.

  • Page 29: End Hms Cs

    Hypertension-Management-Software Client-Server ® In the lower window, the above displayed area of the entire ECG is highligh- ted in blue. ► In order to print the ECG please click on 4.5.3 End HMS CS ► In the upper area of the task bar click on If you changed a file before you will be asked if you want to save data.

  • Page 30: Edit Patient Information

    ► In order to save the new patient, click on Answer the prompt with ► In order to discard the new patient, click on In both cases you will return to the working window. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 31: Select Already Created Patients

    ■ transfer the values from the recently carried out long-term measuring with the measuring device into the HMS CS. ► In the task bar click on The Patient List window with all already created patients in the HMS CS appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 32: Edit Or Change Patient Data

    ► In order to change the address or the patient data enter the new information into the fields. ► In order to add emergency contacts, medical history and medication, click on An additional window appears. ► Enter the information into the fields. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 33: Change The Personal Patient Number (Patient Id)

    ► Answer the prompt with The current patient including their measured data is deleted. 4.6.6 Audit trail To display the record of all patient data changes, click Audit trail in the File bar. I Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 34: Using The Loop-/Event Recorder Beam

    ® ® 4.7 Using the Loop-/Event Recorder Beam ® Connection via Bluetooth The following steps are needed for the use of the ECG Recorders Beam and the ® HMS CS Program for the configuration: Initial Situation: ■ Important: Bluetooth drivers are installed! ■...
  • Page 35 Interfaces window on the Bluetooth tab. ► Click on ® The Bluetooth interface between the ECG Recorder Beam and the HMS CS pro- gram is now configured and the HMS Client Server Software detects from now on ®...
  • Page 36 Hypertension-Management-Software Client-Server ® ECG Recorder Beam ® preparation for recording Initial Situation: ■ ECG Recorder Beam is shut off, ® ■ PC is turned on, ■ Interface for ECG Recorder Beam is known to HMS CS program. ® ECG Recorder Beam ®...
  • Page 37 ECG transmission appears. ► Close the window when the training is success- fully completed. ► Click on Buzzer sounds. ► In the task bar click on ► The program will be closed. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...
  • Page 38 Hypertension-Management-Software Client-Server ® Read out recordings from the ECG Recorder Beam ® via Bluetooth Initial Situation: ■ ECG Recorder Beam is turned on, ® ■ PC is turned on, ■ Interface for ECG Recorder Beam is known to HMS CS program.

  • Page 39: Prepare Ecg Recorder Beam

    - Start training (Device test), see 4.8.7, Training ► Display the desired patient (see 4.6.2, Select already created patient). ► Activate the Bluetooth interface of the ECG Recorder beam , by pressing ® and holding it for 3 seconds.

  • Page 40: Specify Event Recording Times

    You ensure that the measuring device works correctly. ► Click on The Device Tests window appears: ► Click on the respective function keys. ► Answer the prompt with Complete tests ► Click on Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 41: Delete Old Recordings

    ► Click on The Training window appears. ► With connected single-use electrodes you should immediately see the ECG of the patient in the Lifestream and be able to evaluate its quality. ► If you are using the case electrodes you can show the patient the correct posi- tioning and check the quality of the signal.

  • Page 42: Complete Recorder Preparation

    Bluetooth interface. The following steps are processed: - Connect the HMS CS with the recorder, see 4.7 Connection via Bluetooth ® - Transfer recordings from recorder, see 4.7, Read recordings from ECG Recorder Beam via Bluetooth ®...

  • Page 43: Export Ecg Recordings

    ► Display the desired patient (see 4.6.2, Select already created patient). ► In the working window click on the ECG tab. The ECG tab contains a list of already performed recordings on the left side. Beam ® , Operating Manual, Rev. 4.6.1 01/2016,...
  • Page 44 ► In the taskbar click on Series of Measurements and then on Export (Excel), (XML) and (GDT). The export series of measurements window appears. ► Specify directory and name for the file. ► Click on Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 45: Analyse Recordings

    ► Display the desired patient (see 4.6.2, Select already created patient). ► In the working window click on the ECG tab. The ECG tab contains a list of already transferred recordings on the left side. ► Click on a measurement.

  • Page 46: Show And Hide Conductions

    ► Display the desired patient (see 4.6.2, select already created patient). ► In the working window click on the ECG tab. The ECG tab contains a list of already transferred recordings on the left side. ► Click on a measurement.

  • Page 47: Add Comments

    ► Click on a measurement. The belonging ECG will be displayed. ► For the measurement click on one point in the ECG and drag a red triangle or a line from this point. Another click fixes the measurements. The measure- ments of the tagged area appears on the upper left side of the ECG field.
  • Page 48 The belonging ECG will be displayed. ► Double-click on one position where you want to add a comment. A comment window will open. ► Here you can comment on the position and save it with OK. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 49: Print

    ► Display the desired patient (see 4.6.2, Select an already created patient). ► In the working window click on the ECG tab. The ECG tab contains a list of already transferred recordings on the left side. ► Click on a measurement.

  • Page 50: E-Health

    ► Click on Active and activate the e-health Service. ► Enter the username and password, which you received from I.E.M GmbH or your vendor. ► Click on Export Settings. ► The window Export settings appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 51: Import Patients From The E-Health Server

    ► Click on save. The window disappears. 4.11.2 Import patients from the e-health server ► Click on ► The patient list window appears. ► Click on Import Patient. ► The Import window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 52: Export Patients To E-Health Server

    ► Click on import and the blue highlighted patients will be imported into the HMS CS, including any existing series of measurements. 4.11.3 Export patients to e-health server ► Click on ► The patient list window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...
  • Page 53 If you open such a patient all new telemetric measurements are transferred automatically from the e-health server. If you want to revert the authorisation of a patient on the e-health server double- click the Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 54: Gdt-Interfaces

    - Which window appears after program start, see 4.13.8, Options ■ Technical Specifications - Interfaces basics, see 4.13.4, Interfaces - Database, see 4.13.1, Database - e-health Service, see 4.13.3, e-health Service - Bluetooth, see 4.13.8, Bluetooth - GDT-Interface, see 4.13.9 Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 55: Database

    ► In the taskbar click on Settings and then on Language. The Language window appears. ► Click on the desired language in the drop-down menu. ► Click on The window disappears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 56: E-Health Service

    ■ Combi-cable with USB interface ■ infrared (IR) with serial interface ■ infrared (IR) with USB interface ■ Bluetooth. ► In the taskbar click on Settings and then on Interfaces. The Interfaces window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...
  • Page 57 ► Turn on the measuring device and switch to the PAIr-Mode (see 4.7.2, Connection via Bluetooth). ► Click on The Bluetooth device search window appears. After a moment the serial number appears in the window, e.g. C00607. ► Click on the serial number. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 58: Blood Pressure Thresholds (Only For The Abdm Measuring Device Mobil-O-Graph)

    Patient Information tab (see 4.6, Modify Patient Information). Specify thresholds for analysis ► In the taskbar click on Settings and then on Blood Pressure Thresholds. The Blood Pressure Thresholds window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 59: Analysis (Only For The Abdm Measuring Device Mobil-O-Graph)

    ■ With and without day/night key: Settings for the start times of four daytime intervals. 4.13.7 Specify colours for curves and background for results ► In the taskbar click on Settings and then on Colours. The Colours window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 60: Options

    ■ whether the patient list will be displayed at program start or an “empty” wor- king window appears, ■ whether you use Bluetooth. ► In the taskbar click on Settings and then on Options. The Options window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 61: Gdt Settings

    HMS CS. If the correct settings are made here the HMS CS can start your practice software and load the patient data directly from it. ► In the taskbar click on Settings and then on GDT Settings. The GDT settings window appears. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...
  • Page 62 In the HMS CS and the practice software the same name has to be configured. ► Enter the start file HMS_GDT.exe into the settings of the practice computer system. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 63: Service And Maintenance

    Before each use please check: ■The ECG recording with an online transmission (training) to the HMS CS ■The functionality of the LED ■The functionality of the acoustic transmitter Cleaning and Sanitisation: The user (physician) decides, if and when sanitisation of the device for sanitary reasons is applicable (I.E.M.
  • Page 64 Service and Maintenance Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 65: Troubleshooting

    If an error occurs, a 12-tone audible signal will sound. 6.4 Checklist ® Please verify the following checklist if errors occur during the use of the Beam Many errors have simple causes. ■Check that the cable in the Loop/Event mode are tightly connected.

  • Page 66: Error Tables Of Ecg-Recorders Beam

    LED, respective patient in the HMS Memory is full every 2 minutes a 3-tone CS and delete the memory of audible signal. the ECG recorder Beam ®. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 67: Error Tables Of R-R Interval-Detection

    Error code Description Input signal not determinable Length of ECG signal too short (below 15 seconds) or too long (more than 10 minutes) No R-peaks detected or heart rate not plausible Signal quality not sufficient. Analysis in heart rate area not possible Poor signal quality.

  • Page 69: Warranty And Repair Terms

    7. Warranty and Repair Terms ® Warranty: The hardware, i.e. the actual ECG Recorder Beam is warranted by I.E.M. for a period of 2 years. The warranty expires if the device is opened, oper- ated incorrectly or is damaged negligently or intentionally. The also war- ranty expires if the device is repaired by an unauthorised party.
  • Page 70 A change of the burden of proof to the disadvantage of the customer is not associated with the above regulations. The above mentioned terms do not apply to the liability for characteristic and durability warranties or upon deceit and fraudulent concealment. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 71: Appendix

    Guidelines and Manufacturer Statement – Electromagnetic Immunity to Interferences The Loop-/Event Recorder Beam is intended for the operation in the following referred to ® environment. The customer or the user of the Loop-/Event Recorders Beam should ensure ® that it is used in such an environment.
  • Page 72 In order to calculate the electromagnetic environment with regard to stationary transmit- ters, a local evaluation should be considered. If the measured field strength at a location, where the Loop-/Event Recorder Beam ® used, is exceeding the above mentioned corresponding level, the Loop-/Event Recorder Beam®...
  • Page 73 NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies. NOTE 2: These guidelines may not apply to all cases. The emission of electromagnetic values is influenced by absorption and reflection of buildings, objects and people. Beam ® , Operating Manual, Rev. 4.6.1 01/2016, GmbH...

  • Page 74: Important Notes For The Patient

    Handle the connection with care – the plug should slide without much pressure into the port. ■ In normal operational status the ECG recorder will flash green every 2 seconds. If an interference occurs the recorder will issue audible signals.

  • Page 75: Accessories Order List Ecg Recorder Beam

    Appendix 8.3 Accessories Order list ECG Recorder Beam ® Fax-No.: +49 2402-9500-11 Beam ® – The Loop-/Event Recorder Doctor’s surgery : Street: ZIP / City: Phone: Fax: Please send me a quote for the following items  I would like to order the following items ...

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