Beam ECG, Operating Manual

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 EN ...

Page 2: ...e 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 49 0 2402 9500 0 Fax 49 0 2402 9500 11 E Mail service iem de Homepage www iem de ...

Page 3: ... 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 Win...

Page 4: ...am 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...

Page 5: ...e 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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Page 7: ...ent 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 an...

Page 8: ...e 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 ...

Page 9: ...oop 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 electrode...

Page 10: ...e 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 s...

Page 11: ...lts by the physician 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 Telemetrically sent data can be queried by the HMS CS 3 2 Unpacking All parts included in the scope of the delivery were packed appropriately and tested on com...

Page 12: ...ding is activated LED flashes green twice every 5 seconds Error message Priority 1 Fatal Error LED continuously flashes red every 2 minutes a 3 tone audible signal Error message Priority 2 Main battery discharged LED flashes red every 2 seconds every 2 minutes a 3 tone audible signal Error message Priority 3 Single use electrodes in the Loop mode have no contact LED flashes red twice every 5 secon...

Page 13: ...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 A disadvantage is the use of single use electrodes and the permanent body contact Warning After the start of operation or upon changing the electrode a waiting period will occur which is dependent on the configured lo...

Page 14: ...train relief for the cable adhesive tape made of same material as electrodes in order to avoid direct pressure on the electrodes Prepare the skin for a better signal transmission by shaving the positions for the single use electrodes and removing the upper fragile epithelial layer e g with fine sandpaper and degreasing the skin on these spots e g with medical benzine Position the single use electr...

Page 15: ...ning 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 When using the device electrodes the correct positioning and the correctly applied pressure can be determined and indicated to the patient Follow the description in chapter 4 8 7 The device can be carried o...

Page 16: ...mode by pressing and holding the start button inserting the battery and keep holding the start button for another 5 seconds until an audible signal confirms that pairing mode and the LED is continuously green Your Beam now opens a Bluetooth interface of the initially located radio You should ensure that for pairing only the desired cell phone or modem has an active Bluetooth interface in the immed...

Page 17: ...n 15 sec inter vals Recordable Events dependent from the set event period Event Transmission e health Via Mobile GPRS after each reading Memory Capacity 16Mbit maximum of 28 minutes Battery Capacity Event Mode 40 days at BT transmission 46 without for 5 events at 15 seconds each per day Loop Mode 10 days for BT transmissions for 5 events at 15 seconds each per day Streaming 7 hours of permanent tr...

Page 18: ...to a recycling facility for electric and electronic devices For further information please refer to your community the local waste manage ment or your vendor Defilibration Protected Meaning Defibrillation protected use part of Type B Warning please read accompanying documentation Meaning Warning please read accompanying documenta tion Manufacturing Date Meaning Date of production CE Sign Meaning T...

Page 19: ...to connect an e health service Telemedicine also for further devices by I E M offering a significantly higher security for the patient and an additional facility for the physician at the same time In addition to other products the following are available Blood pressure monitoring with the Ambulant Blood Pressure Monitor System Mobil O Graph NG the upper arm measuring device Stabil O Graph mobil an...

Page 20: ... Bluetooth Adapter Details can be found in this text Note Please only plug the USB Adapter into the computer after the software instal lation or when you are prompted to do so 4 2 1 System Requirements 1 Computer 1 GHz 512 MB RAM 100 MB Hard Disk Storage 1024x768 Pixel Two spare USB Ports 2 Operating System a Windows 2000 SP4 XP Vista b Mac OS X 10 4 or newer c Linux with Intel AMD Processor GNU L...

Page 21: ...th BlueZ or Affix Bluetooth Stack no installation necessary 4 2 2 Installation for Windows Note Please only plug the Bluetooth Adapter into the computer after the software installation or when you are prompted to do so Important If you are using the USB interface and or Bluetooth then please first install the respective drivers Procedure 1 Install application from CD ROM 2 If required install driv...

Page 22: ...es For this purpose you will need to open the Bluetooth properties after the installation and mark the checkbox as shown here in the image Install USB Drivers Note Please connect the USB Adapter USB Stick or cable with USB interface only after the software has been installed on the computer In the installation menu click on USB cable drivers Follow the instructions on the screen The software insta...

Page 23: ... link to the HMS CS file on your desktop The software installation is now finished On the installation CD there are several documents in the Docs directory first steps quick manuals operating manuals The available documents are displayed clearly via index htm 4 3 Start and close HMS CS For the operation of the HMS CS program we assume basic knowledge and experience with the Windows OS MacOS or Lin...

Page 24: ...the symbols for the individual process steps The working window contains the two tabs Patient Information and Readings 4 4 1 Menu Bar At the very top of the operating window is the Menu Bar Each menu item combines functions Menu File Menu Item Function Patient List Show list of already created patients New patient Create new patient Import Import of patient data Abdm mdb GDT and patient Data back ...

Page 25: ...series of data to an excel file Export XML Save currently selected series of data to an XML file Export GDT Save currently selected series of data to an GDT file delete Delete selected series of measurements Menu Settings Note For detailed information please see 4 13 Configure Standard Settings for HMS CS Menu Item Function Database Configure Database only for experienced users Language Specify la...

Page 26: ...atient Add new patient see 4 6 1 Create New Patient Patient List Display list of already created patients see 4 6 2 Select already created patients Prepare device Program measuring device for the next long term measurement Read out device Read out measured values from recorder Start PWA A pulse wave analysis reading in the Mobil O Graph NG will be started Bluetooth red Bluetooth not active green B...

Page 27: ...t important func tions using the sample patient Doe John For the operation of the HMS CS program we assume basic knowledge and experience with the Windows OS Mac OS or Linux Double click on the desktop on The HMS CS program is started Information about the loading progress of the program appears e g program version progress bar The working window and the window Patient List appear 4 5 1 Show Sampl...

Page 28: ...of bir th of the patient The Patient Information tab contains several areas Address Patient Data Emergency Contacts Medical History and Medication 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: ... 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 Information about the closing progress appears The HMS CS working window disappears ...

Page 30: ...patient information from different sources All patient information can be changed anytime after its creation 4 6 1 Create new patient In the task bar click on The New Patient window appears Patient ID and Last Name are mandatory fields both information are sorting or search criteria all other information is optional Tip Use the tab key to jump from one field to the next In order to save the new pa...

Page 31: ...cal History and Medication 4 6 2 Select already created patients From all in the HMS CS created patients select one patient in order to look up their previous readings prepare the measuring device for this patient or 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 creat...

Page 32: ...ven during entering of the data the HMS CS searches the database and dis plays the found patients click on the respective list entry and then on Tip It s quicker to just double click the list entry You will return to the working window further procedure see 4 6 3 Edit or chan ge patient data If you can t find the desire patient click on The New Patient window appears further procedure see 4 6 1 Cr...

Page 33: ...In the taskbar click on Patient and then on change ID The change Patient ID window appears with the current patient number Change the patient ID Click on 4 6 5 Delete Patient In the taskbar click on Patient and then on Delete 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 t...

Page 34: ...n Step ECG Recorder Beam PC 1 Start the HMS CS program Assuming the respec tive program settings the Patient List window appears see 4 13 8 Options In this case select any patient see 4 6 2 Select already crea ted patient In the taskbar click on set tings and then on inter faces In the interfaces window click on the Bluetooth tab Click on A Note appears Turn on the device and switch to the PAlr mo...

Page 35: ...dow e g 180000H1 Click on the serial num ber Click on A Note appears The one time Pairing was successful Click on 5 Buzzer sounds 6 The measuring device appears in the 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 the ECG Recorder Beam as soon as ...

Page 36: ...face for ECG Recorder Beam is known to HMS CS program Step ECG Recorder Beam PC 1 Insert the battery into the ECG Recorder Beam 2 Start the HMS CS program In the task bar indicates the active Bluetooth connection Display the patient see 4 6 1 Create new patient and 4 6 2 Select already created patient 3 Press and hold for 3 seconds The buzzer sounds and the LED turns orange 4 The Device action win...

Page 37: ...ning The time will be taken transferred from the com puter Check the correct time on your computer Click on If you are using single use electrodes now plug the cables into the device Click on The training window with an online ECG transmission appears Close the window when the training is success fully completed Click on 6 Buzzer sounds 7 In the task bar click on The program will be closed ...

Page 38: ... indicates the active Bluetooth connection The Device action window appears 2 Remove the measuring device from the patient remove electrodes from patient and cables from measuring device Press and hold for 3 seconds 3 The buzzer sounds and the LED turns orange 4 Click on question appears Assign mea sured data to patient with pati ent ID xxx Click on After the data transfer the Delete measured valu...

Page 39: ...ent Recorder Beam The following steps are processed Specify Loop Event recording time see 4 8 1 Specify measuring protocol Configure device clock see 4 8 2 Configure device clock Transfer Patient ID see 4 8 3 Transfer Patient ID Device Test see 4 8 4 Test measuring device Delete old recordings see 4 8 5 Delete old measurements Activate E health Online Transmission see 4 8 6 Activate E health onlin...

Page 40: ...k You transfer the time of your PC to your measuring device Click on Answer the prompt with 4 8 3 Transfer Patient ID You save the patient ID of the selected patient in the measuring device Later at the transfer of the long term measured values the HMS CS program recognizes the patient automatically Click on Answer the prompt with 4 8 4 Test measuring device You ensure that the measuring device wo...

Page 41: ...r the activation of the e health function please go to the prepare measuring device window and click on 4 8 7 Training You ensure that the recorder is working correctly and the electrodes are positioned correctly and the patient places the device correctly on his chest Click on The Training window appears With connected single use electrodes you should immediately see the ECG of the patient in the...

Page 42: ...order see 4 7 Connection via Bluetooth Transfer recordings from recorder see 4 7 Read recordings from ECG Recorder Beam via Bluetooth Start the HMS CS program Assuming the respective program settings the Patient List window appears see 4 13 8 Options In this case select any patient see 4 6 2 Select already cre ated patient Bring your ECG Recorder Beam into the communication mode by pressing and ho...

Page 43: ...n Click on The tab with the ECG recordings appears The transferred recordings will be displayed as graphics similar to mm paper calibration spike see 4 10 Analyse Recordings 4 9 5 Export ECG Recordings The recordings which you have transferred to the HMS CS can be saved to a file Using this file you can transfer the measuring results into your practice system Display the desired patient see 4 6 2 ...

Page 44: ...ion Management Software Client Server 4 Click on the recording to be exported 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 ...

Page 45: ...ter and zoom Show and hide conductions Measuring the ECG using the mouse pointer Add comment Print 4 10 1 Set filter and zoom 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 The belonging ECG will be displayed For the determination of...

Page 46: ...s Based on these data the HMS CS will then provide a calculation of the mean heart rate on a complete measurement The HMS CS detects a different signal quality in the R waves In case of best signal quality all time intervals from R to R will be indicated in black numbers A non optimal signal quality will be indicated in red numbers for the time data between two R intervals Values marked in red wil...

Page 47: ...he measure ments of the tagged area appears on the upper left side of the ECG field Click again somewhere in the ECG graph and the line or triangle disappears Additionally there is 1 mV sized calibration spike for an improved scale recognition on the lower left side of the ECG figure 4 10 5 Add comments Display the desired patient see 4 6 2 Select already created patient In the working window clic...

Page 48: ...ypertension Management Software Client Server 4 Click on a measurement 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 ...

Page 49: ...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 The belonging ECG will be displayed To print click on this tab A print window will open Click on the analysis and settings to be printed Click on The print window appears ...

Page 50: ...t server solution you can Create patients for e health on the e health server Synchronise the data of selected patients with the e health server Query telemetrically raised measured values Save measured values and recordings from the practice to the server and make them accessible to co workers 4 11 1 Activate e health Service In the taskbar click on Settings and then on e health Service The e hea...

Page 51: ...ecify what data will be transferred to the e health server and if they should be sent anonymized If the Anonymize field is checked only the patient ID will be used 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 ...

Page 52: ...Highlight the patients which you want to import from the e health server to the HMS CS 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 ...

Page 53: ...nised using the symbol After the import or export of patients the patients authorised for the e health database are marked with a small in the patient list and therefore authorised for the synchronization with the e health server 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 ...

Page 54: ...gured 4 12 1 Transfer result reports to the practice software Either close the HMS CS or set the HMS CS into observation mode You access the observation mode by clicking on the symbol right of the IEM Logo The software is then minimised and waits in the background for inco ming GDT data As soon as a file is found the software starts automatically with the patient 4 13 Configure Standard Values for...

Page 55: ...e you also specified the access to the database For further information please refer to your vendor or directly to I E M GmbH In the taskbar click on Settings and then on Database The Database window appears Enter the desired information Click on The window disappears 4 13 2 Switch Language The user interface offers you various languages In the taskbar click on Settings and then on Language The La...

Page 56: ...vice The e health Service window appears Enter the desired information Click on The window disappears Further information can be found in chapter 4 11 4 13 4 Interfaces Here you specified the interfaces which connect the measuring device with the PC For the Loop Event Recorder Beam only Bluetooth can be used Cable with serial interface COM1 2 Combi cable with USB interface infrared IR with serial ...

Page 57: ...ecify Bluetooth interface for a measuring device In the Bluetooth tab click on A Note appears Turn on Mobil O Graph NG and switch to PAIr mode 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 ...

Page 58: ...nformation click on The Interfaces window disappears 4 13 5 Blood Pressure Thresholds only for the ABDM Measuring device Mobil O Graph You can specify global thresholds for systolic and diastolic blood pressure Upon exceeding the threshold the measured values will be marked accordingly in the analysis These values will be automatically saved as thresholds for new created patients Note You can spec...

Page 59: ...ph Here you can select different settings for the analysis Initial Additional Start Interval to the four Daytime Intervals Static Start Start Time of graphic display Tabular display Here the result report can be switched to a tabular display 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 task...

Page 60: ... for the ABDM Measuring device Mobil O Graph Calculation of mean arterial pressure measured or calculated MAP only for the ABDM Measuring device Mobil O Graph which measured value analysis will be displayed after the transfer of the measured values from the device to the HMS CS device Measured Value table or Graph only for the ABDM Measuring Device Mobil O Graph whether the patient list will be di...

Page 61: ...established medical doctors The GDT interface serves for the system independent data transfer between medical measuring devices and a practice computer system The GDT settings are required for the automatic exchange of patient data between your practice and the 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...

Page 62: ...nter the name of the GDT file in the Practice Computer system HMS cli ent server field which transfers the patient data from your practice software to the HMS CS In the HMS CS and the practice software the same name has to be configured Enter the name of the GDT file in the HMS client server Practice Computer system field which transfers the result report from your HMS CS to the practi ce software...

Page 63: ...ntact with the interface of the recorder or penetrate the interior of the recorder Do not spray disinfectant onto the recorder but use a damp cloth for the cleaning and sanitising Do not put either the recorder or the electrodes into a disinfectant solution The user is responsible for any damage caused by the use of other disinfectants which are not recommended by I E M Never use disinfectants whi...

Page 64: ...64 Beam Operating Manual Rev 4 6 1 01 2016 GmbH Service and Maintenance 5 ...

Page 65: ...ery 6 2 Battery voltage curve Figure 6 2 1 Good battery quality Figure 6 2 2 Bad battery quality 6 3 Transmission errors To avoid errors during data transmission the monitor contains a verification of the data 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 tha...

Page 66: ... tone red flashing of the LED every 5 minutes a 3 tone audible signal Error message Priority 3 Single use electrodes in the Loop mode are not connected Check that the cable plug is securely attached to the device port Check that the adhesive electrodes are securely attached to the patients chest Only use single use electrodes of branded manufacturers Plug the single use elec trodes first onto the ...

Page 67: ... rate not plausible 4 Signal quality not sufficient Analysis in heart rate area not possible 5 Poor signal quality No reliable values If signal is too poor No values 6 Standard deviation on all R R intervals is too large 7 Too much time elapsed until start of ECG data that might be useful for analysis in proportion of length of ECG signal Note ECG recording needs to be at least 5 seconds longer th...

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Page 69: ...f the defect results from a disregard of the operating manual inappropriate use wetness dampness extreme heat or climatic conditions or temporary fluctuation of respective factors or cor rosion oxidation unauthorised access or connecting attempts unauthor ised opening or repair repair attempts using not authorised spare parts mis use inappropriate installation accidents acts of God spilling of foo...

Page 70: ... not apply to independent liability according to product liability acts Also it does not apply to the liability from culpable breaches of essential contractual obligations but the liability is insofar restricted to the predictable contract typical damages except for cases as in 1 and 2 A change of the burden of proof to the disadvantage of the customer is not associated with the above regulations ...

Page 71: ... area and those which are directly connected to a public power supply which provides power to buildings that are also used residentially 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 ...

Page 72: ... The field strength of a stationary radio transmit ter should according to a local evalu ation be less than the corresponding level for all frequencies In the vicinity of devices which carry the symbol for non Ionising emission interference is possible 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 ...

Page 73: ... below Safe Distance dependent on the transmitter frequency in m Nominal power of transmitter P in W 0 01 0 1 1 10 100 80 MHz to 800 MHz d 1 17 Root P W 0 12 0 37 1 17 3 70 11 70 800 MHz to 2 5 GHz d 2 33 Root P W 0 23 0 74 2 33 7 37 23 30 150 KHz to 80 MHz not applicable not applicable not applicable not applicable not applicable For transmitters whose maximum nominal power is not stated in the a...

Page 74: ...n The recorder flashes red every two seconds The battery is discharged 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 interferences can only be remedied with the assistance of the physician The recorder flashes red three times every 6 seconds The recording memor...

Page 75: ...the following items Item Quantity ECG single use electrodes 100pcs packing unit e health Service Single use electrode cable Bag for recorder Battery I am interested in another Beam ECG Loop Event Recorder with the trade in of old device without the trade in of an old device I am interested in the e health Service I am interested in information for the following devices Mobil O Graph Tel O Graph Li...

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