Beam ECG User manual

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

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
Germany
Phone: [phone] - 9500 0
Fax: [phone] - 9500 11
E-Mail: [email protected]
Homepage: www.iem.de

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Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
Inhaltsverzeichnis
1. Introduction
1.1 Preamble .................................................................................. 7
1.2 About this Operating Manual.................................................... 7
1.3 Classification ............................................................................ 7
1.4 CE Sign .................................................................................... 7
1.5 Scope of Delivery .................................................................... 8
2. Directions for use
2.1 Intended Use............................................................................ 9
2.2 Not intended use ...................................................................... 9
2.5 Important Notes for the Physician............................................ 9
2.6 Important Notes for the Patient .............................................. 10
3. Product Description..............................................................
3.1 Introduction..............................................................................11
3.2 Unpacking ...............................................................................11
3.3 The Recorder ..........................................................................11
3.3.1 The Start Button ............................................................................... 12
3.3.3 Audible and visual signal.................................................................. 12
3.3.4 The electrode cable.......................................................................... 12
3.3.5 The Bluetooth-Interface.................................................................... 13
3.4 Recording process ................................................................. 13
3.4.1 Loop (with cable single-use electrodes)........................................... 13
3.4.2 Event (with case electrodes) ............................................................ 13
3.5 Recording Preparation ........................................................... 14
3.6 E-health Preparation .............................................................. 16
3.7 Technical Data........................................................................ 17
3.8 Symbols.................................................................................. 18
4. Hypertension-Management-Software Client-Server®
4.1 Working with HMS CS............................................................ 19
4.2 Install Software....................................................................... 20
4.2.1 System Requirements ...................................................................... 20
4.2.2 Installation for Windows®................................................................ 21
4.2.3 Installation for Macintosh®OS 10.4 and newer................................ 22
4.2.4 Installation for Linux ......................................................................... 23
4.3 Start and close HMS CS ........................................................ 23
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

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Table of Contents 3
4.5.2 Display measured data of the sample patient.................................. 28
4.5.3 End HMS CS.................................................................................... 29
4.6 Edit Patient Information.......................................................... 30
4.6.1 Create new patient ........................................................................... 30
4.6.2 Select already created patients........................................................ 31
4.6.3 Edit or Change Patient Data ............................................................ 32
4.6.4 Change the personal patient number (patient ID)............................ 33
4.6.5 Delete Patient................................................................................... 33
4.6.6 Audit trail .......................................................................................... 33
4.7 Using the Loop-/Event Recorder Beam®........................ 34
4.8 Prepare ECG Recorder Beam®.............................................. 39
4.8.1 Specify Event recording times.......................................................... 40
4.8.2 Configure device clock ..................................................................... 40
4.8.3 Transfer Patient-ID ........................................................................... 40
4.8.4 Test measuring device .........................................................................
.......................................................................................................... 40
4.8.5 Delete old recordings ....................................................................... 41
4.8.6 Activate E-health online transmission .............................................. 41
4.8.7 Training............................................................................................. 41
4.8.8 Complete recorder preparation ........................................................ 42
4.8.8 Activate recording mode of ECG Recorder Beam®.......................... 42
4.9 Read out recordings from recorder ........................................ 42
4.9.5 Export ECG Recordings................................................................... 43
4.10 Analyse Recordings ............................................................... 45
4.10.1 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 Activate e-health Service.................................................................. 50
4.11.2 Import patients from the e-health server .......................................... 51
4.11.3 Export patients to e-health server .................................................... 52
4.12 GDT-Interfaces ....................................................................... 54
4.12.1 Transfer result reports to the practice software ............................... 54
4.13 Configure Standard Values for the HMS CS.......................... 54
4.13.1 Database .......................................................................................... 55
4.13.2 Switch Language.............................................................................. 55
4.13.3 e-health Service ............................................................................... 56
4.13.4 Interfaces.......................................................................................... 56
4.13.5 Blood Pressure Thresholds (only for the ABDM Measuring device
Mobil-O-Graph)................................................................................. 58
4.13.6 Analysis (only for the ABDM Measuring device Mobil-O-Graph) ..... 59
4.13.7 Specify colours for curves and background for results .................... 59
4.13.8 Options ............................................................................................. 60
4.13.9 GDT Settings.................................................................................... 61
5. Service and Maintenance
6. Troubleshooting

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Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
3. Product Description
3
6.1 Main error sources ................................................................. 65
6.2 Battery voltage curve ............................................................. 65
6.3 Transmission errors................................................................ 65
6.4 Checklist................................................................................. 65
6.5 Error tables of ECG-Recorders Beam®................................. 66
6.6 Error tables of R-R Interval-Detection ................................... 67
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

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Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
1. Introduction
1.1 Preamble
With this ECG Loop-/Event Recorder, Beam®, you own a state of the art system.
The ECG Loop-/Event Recorder can be prepared for a new patient in a practice
within a few minutes and can therefore be integrated into the daily operation of
the practice quickly.
Additionally to the known Loop/Event recording the recorder also provides the
option to send recordings via the mobile network and to inform the physician
about incoming readings. The patient does not need to appear in the practice for
the analysis. Only after receipt of a qualitatively sufficient reading an appointment
is setup with the patient.
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
the ECG Loop-/Event Recorder Beam®can be operated.
For the management of the ECG Loop-/Event Recorder Beam
®
, I.E.M GmbH offers
the following Software:
■Hypertension-Management-Software Client-Server Data Management
(HMS CS) Version 3.0 or higher.
■The Loop/Event Recorder Beam®cannot be used without the HMS CS.
References to specific version characteristics only apply to the the relevant parts
of the respective version.
Important: The operating manual describes the ECG Loop-/Event Recorder
Beam®and the accessories in the order in which you start to operate
the device and use it later on. The general explanation, the installation,
launch, and reading preparation, is followed by the setup of the patient
and analysis. The individual functions will only be explained when
they are needed. This way you will be introduced to the Loop/Event
Recorders Beam®step-by-step.
The operating manual must always be available to the user.
1.3 Classification
The ECG Loop/Event-Recorder Beam®is a medical device of the class IIa accord-
ing to Rule 10, Annex IX, Directive 93/42EEC.
1.4 CE Sign
The Beam®meets the requirements for the Medical Device Directive
93/42/EEC and carries the CE sign.
The Beam®meets the requirements of the R&TTE Directive 1999/5/EC
and carries the CE-sign.

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Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
Introduction 3
The conformity declaration for the product can be downloaded from the I.E.M.
Website www.iem.de
The device meets all requirements for the norms applicable according to the direc-
tives.
1.5 Scope of Delivery
Basis Set
1. Beam®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

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Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
2. Directions for use
2.1 Intended Use
The intended use is the recording of ECG events for adults.
The indications for an examination with an ECG Loop-/Event Recorder are:
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. A two week
recording by a ECG Loop-/Event Recorder appears optimal for the clarification of
palpitations.
The ECG Loop-/Event Recorder Beam®may only be used after medical attention
and instruction. The ECG signal is exclusively displayed in a raw format and is not
analysed by the accompanying HMS CS software.
2.2 Not intended use
The ECG Loop-/Event Recorder Beam®may not be used for ECG recordings in
intensive care units and at surgeries.
The diagnosis may not be solely based on the ECG Data of the ECG Loop-/Event
Recorder Beam® .
The ECG Loop-/Event Recorder, Beam® is not appropriate for ECG-recordings of
syncopes without prodromes.
The ECG Loop-/Event Recorder, Beam® is not approved for children with a body
weight of less than 10 Kg.
2.5 Important Notes for the Physician
■The diagnosis may not be based solely on the ECG Loop-/Event Recorder,
Beam®ECG Data, because the position and the distance of the electrodes is
not standardised.
■The recording of pacemaker signals is not always possible because of the
sampling rate.
■Please inform the patient that the electrodes should be removed upon the
occurrence of skin rashes or itching in the area, where the electrodes touch the
skin, or if the electrodes no longer touch the skin.
■Please inform the patient about the importance of the correct positioning of the
electrodes.
■The device may not be operated in areas close to a MRI or other significant
magnetic fields.
■The use of components, which were not in the scope of the delivery, can lead
to faulty recordings. Only use original parts by I.E.M. GmbH.
■The ECG Loop-/Event Recorder Beam®was designed for battery-powered
operation and may not be operated by an external power source, e.g. a DC
adapter, or be in a direct connection with the power circuits.
■Please maintain hygiene according to maintenance plan.

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Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
Directions for use 2
■Pay attention to the maximum operating period of used single-use electrodes
and inform your patient about the period and the affixing of new electrodes.
■Only use single-use electrodes which are appropriate for the skin type of your
patient.
2.6 Important Notes for the Patient
■Please comply with the instructions of your physician.
■Stay calm during the reading until the process is finished.
■The ECG Recorder Beam® comes with a cable recognition. Wait for a short
audible signal on plugging in the cable, only then is the cable correctly
plugged in. For the correct positioning you can find a red dot on the plug
and on the case, which belong together. 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.
The following errors can be remedied by you, if this was discussed
previously with the physician:
• The Recorder flashes red every 2 seconds:
The battery is flat – replace the battery.
• The Recorder flashes red twice every 5 seconds:
One electrode has insufficient contact – check the positioning of the
electrode as shown by the physician.
The following errors can only be remedied with the assistance of the phy-
sician:
• The recorder flashes red three times every 6 seconds:
The recording memory is full – Contact your physician for further
instructions.
• The recorder flashes red without interruption:
Remove the device and contact your physician for further instructions.
Warnings:
■The ECG recorder Beam®should not come in contact with any fluids. Do
not wear the device when taking a shower or bath!
If water should penetrate the device it can not be used anymore. Please
remove the battery immediately.
■If skin irritations, rashes, or itching occurs in the area of the electrodes
please remove the electrodes and inform your physician.
■Inform your physician if the device does not flash green every 2 seconds.
Please find a template copy for the patient in the attachment!