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Operating instructions Ambulatory 24-hour blood pressure monitoring system for the products: ® Mobil-O-Graph ® Mobil-O-Graph 0044 Blood pressure monitor Pulse Wave Analysis (PWA) Analysis unit: Hypertension Management Software Client-Server Version 5.1 (HMS CS 5.1) Dealer:...
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The contents may not be copied or published without written permission from I.E.M. GmbH. Manufacturer: I.E.M. Industrielle Entwicklung Medizintechnik GmbH Cockerillstrasse 69 52222 Stolberg Germany Tel.: + 49 (0)2402 - 9500 0 Fax: + 49 (0)2402 - 9500 11 e-mail: iem.office@iem.de Homepage: www.iem.de...
Contents 1. Introduction ......................7 1.1 Foreword .......................7 1.2 Operating Instructions ................... 7 1.3 Clinical tests ....................7 1.4 CE mark ......................7 1.5 Scope of delivery ...................7 2. Operating instructions ..................9 2.1 Intended use....................9 2.2 Incorrect use....................9 2.3 Indication .......................9 2.4 Side effects of 24-hour blood pressure monitoring ........
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Contents 4.6.7 Enter office measurements BP ................... 28 4.6.8 Enter office measurements weight ................28 4.6.9 Audit trail ........................29 4.7 Using the Mobil-O-Graph ® blood pressure monitor ........29 4.7.1 Connection via cable ....................29 ® 4.7.2 Connection via Bluetooth ..................
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Contents 6. Troubleshooting....................77 6.1 Principal sources of error ................77 6.2 Battery voltage curve .................. 77 6.3 Transmission errors ..................77 6.4 Check list ..................... 77 6.5 Error tables ....................77 ® 6.5.1 Troubleshooting, Mobil-O-Graph ................77 ® 6.5.2 Communication errors, Stabil-O-Graph ..............
R&TTE Directive 1999/5/EU and bears the CE mark. The declaration of conformity for this product can be downloaded from the I.E.M. website www.iem.de. This device fulfils the requirements of the standards applicable in accordance with the Directives. In particular, it fulfils the applicable requirements of the following standards: 1.
■ The equipment must never be connected to a PC or other unit while still fitted to the patient. ■ The use of components not supplied with the equipment can lead to incorrect measurements. Use only accessories offered by IEM. ®...
2. Operating instructions Countermeasures: The doctor should draw the patient’s attention to the fact that the cuff must be worn on the upper arm only and care must always be taken to ensure that neither the shoulder strap nor the air tube can ever become wrapped around the neck.
3. Product description 3.1 Introduction ® The Mobil-O-Graph system consists of two principal components: ■ the Mobil-O-Graph ® NG or Mobil-O-Graph ® PWA with different cuffs and further accessories. ■ analysis software for the doctor to analyse the measurements. Measurements from ABP monitor can be interpreted using the analysis unit HMS Client-Server. Using this soft- ware, saved measurements can be downloaded to a PC, presented on the screen in various forms, as dia- grams, lists and statistics, and printed out.
3. Product description 3.3.2 DAY/NIGHT The DAY/NIGHT key allows waking and sleeping phases to be differentiated when record- ing, which is important from the point of view of statistical evaluation and graphic presenta- tion. For precise details of the effects on the printout, please see the relevant sections on analysis.
3.3.6 3. Product description 3.3.6 Infrared interface The infrared interface provides an equal, wireless alternative to the data port. To use this interface you will need the PC infrared interface IR-Med. The infrared interface can be obtained from your specialist dealer (see sec- tion: The analysis unit).
3. Product description 3.4.6 You can set the protocols manually by holding down the Day/Night and then pressing the Event key. Use the Start/Stop key to change the protocol, and confirm with the Event key. Protocol Day time Night time Measurements Acoustic signal Measurements...
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3.4.6 3. Product description Please note the following points: IMPORTANT: 1. When putting the recorder on the patient, the recorder must not be connected to other external equip- ment! 2. The cuff must fit so that the air tube cannot be kinked or compressed at any point. The tube connection on the cuff should therefore be directed upwards.
2 NiMH batteries, each 1.2 V and at least 1500 mAh (AA, Mignon) 2 alkaline 1.5 V batteries (AA, Mignon) Interfaces: Serial (cable) Infrared IEM-specific Bluetooth (Class 1/100 m) 3.6 Symbols Battery symbol Meaning: The symbol shows the type of voltage.
4. Hypertension Management Software Client-Server The monitor measures blood pressure and stores the measurement. On completion of measurements, the stored measurements are transferred to your computer. You can then analyse the measurements according to your requirements. The patient file contains important data such as: ■...
4. Hypertension Management Software Client-Server 4) Prepare monitor 5) Quit HMS CS. ■ After 24-hour monitoring: Process data 1) Start HMS CS 2) Connect HMS CS to monitor 3) Read out measurements from the recorder 4) Analyse data 5) Quit HMS CS. 4.2 Installing the software The software is able to communicate with the monitor via different interfaces.
4.2.2 4. Hypertension Management Software Client-Server ® 4.2.2 Installation for Windows Note: Please insert the USB adaptor (USB stick or cable with USB interface) only after installing the software onto your computer, or when prompted to do so. Important: If you are using the USB interface and/or Bluetooth, you must first install the corresponding driver. Procedure: 1) Install application from CD-ROM 2) If necessary, install drivers from CD-ROM in the following order:...
4. Hypertension Management Software Client-Server 4.2.4 4.2.4 Installation for Linux Procedure: 1) Install the application from the CD-ROM 2) Plug Bluetooth adapter and/or USB adapter into your computer. Install the application from the CD-ROM ► Log in as System Administrator (root). ►...
4. Hypertension Management Software Client-Server 4) Select the appropriate file containing your backed-up data. 5) Click Open. 6) Confirm that you wish to restore your data. 7) Your data is restored. 4.3 Starting and quitting HMS CS ® ® ® Basic knowledge and experience of the operating systems Windows , Macintosh or Linux...
4. Hypertension Management Software Client-Server 4.4.1 Figure: control window with Patient information tab. You can call up functions in the Menu bar at the top of the window. The Toolbar directly under the Menu bar contains buttons (symbols) for individual process steps. The task panel contains the two tabs Patient informa- tion and Measurements.
4.4.2 4. Hypertension Management Software Client-Server ■ Menu ? Menu item Function About... Display information about HMS CS version 4.4.2 Toolbar At the top of the control window, below the Menu bar is the Toolbar. It contains buttons (symbols) for calling up important functions quickly.
4. Hypertension Management Software Client-Server 4.5.1 4.5.1 Displaying sample patient ► Click the line containing Doe, John and then Tip: It is even quicker to double-click the line. Patient information is shown in the control window. Top right in the window you will see the patient’s name and date of birth. The Patient information tab contains several fields: address, patient data, emergency contacts, medical history and medication.
4.5.3 4. Hypertension Management Software Client-Server ► Click a monitoring session Its Table of measurements is displayed. The highlighted values are measurements that lie outside the defined limits (see 4.12, Setting standard val- ues for HMS CS). ► To display further analyses, click the header of the analysis you wish to see. Tip: If your mouse pointer hovers over a tab header, a brief explanatory text will appear (Tooltip).
4. Hypertension Management Software Client-Server 4.6.2 Patient ID and Surname are mandatory fields (both details are criteria for searching and sorting), all the other details are optional. Tip: Use the tab key to jump from one field to the next. ►...
4.6.3 4. Hypertension Management Software Client-Server If you see the required patient in the window, ► click the list entry and then Tip: It is even quicker to double-click the list entry. This takes you back to the control window (for how to proceed further see 4.6.3, Supplementing or modi- fying patient data).
■ you can type in self-measured values, ■ Values that the patient’s scales have recorded and transmitted to the IEM server can be called up via synchron ization with the IEM server (for further information, please contact your specialist dealer or I.E.M.
4.6.9 4. Hypertension Management Software Client-Server ► In the window Manual weight measurement type in weight, date and time. ► Click 4.6.9 Audit trail To display the record of all patient data changes, click Audit trail in the File bar. 4.7 Using the Mobil-O-Graph ®...
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4. Hypertension Management Software Client-Server 4.7.1 ® Configuring interface between Mobil-O-Graph and HMS CS Starting situation: ■ Monitor is connected to the PC, ® ■ Mobil-O-Graph is switched on, ■ PC is switched on. ® Step Mobil-O-Graph ► Start HMS CS. If the program is set up for this, the window Patient list will appear (see 4.12.7, Extras).
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4.7.1 4. Hypertension Management Software Client-Server Begin 24-hour monitoring Starting situation: ■ The monitor should be disconnected from the PC. ® Step Mobil-O-Graph ► Put the monitor on the patient (put on the cuff and connect it to the recorder). ®...
4. Hypertension Management Software Client-Server 4.7.2 ® Read out measurements from 24-hour monitoring from Mobil-O-Graph Starting situation: ■ Monitor is connected to the PC, ® ■ Mobil-O-Graph is switched on, ■ PC is switched on, ® ■ Mobil-O-Graph interface recognises HMS CS. ®...
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4.7.2 4. Hypertension Management Software Client-Server ® Configuring interface between Mobil-O-Graph and HMS CS Starting situation: ■ important: Bluetooth driver is installed! ■ PC is switched on. ® Step Mobil-O-Graph ► Start HMS CS. If the program is set up for this, the window Patient list will appear (see 4.12.7, Extras).
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4. Hypertension Management Software Client-Server 4.7.2 ® Preparing the Mobil-O-Graph for 24-hour monitoring Starting situation: ® ■ Mobil-O-Graph is switched off, ■ PC is switched on, ® ■ Mobil-O-Graph interface recognises HMS CS. ® Step Mobil-O-Graph ® ► Switch on the Mobil-O-Graph ►...
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4.7.2 4. Hypertension Management Software Client-Server Begin 24-hour monitoring Starting situation: ® ■ Mobil-O-Graph is switched on. ® Step Mobil-O-Graph ► Put the monitor on the patient (put on the cuff and connect it to the recorder). ► Press for a manual measurement, to ensure that the monitor works as it should.
4. Hypertension Management Software Client-Server 4.7.3 4.7.3 Connection via infrared (IR) ® The IR-Med infrared interface enables wireless data transmission between the Mobil-O-Graph monitor and the PC. The IR-Med infrared interface is connected to the PC by cable: ■ via serial interface (COM1,2...) or ■...
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4.7.3 4. Hypertension Management Software Client-Server ® Configuring interface between Mobil-O-Graph and HMS CS Starting situation: ■ Monitor is connected to the PC, ® ■ Mobil-O-Graph is switched on, ■ PC is switched on. ® Step Mobil-O-Graph ► Start HMS CS. If the program is set up for this, the window Patient list will appear (see 4.12.7, Extras).
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4. Hypertension Management Software Client-Server 4.7.3 Begin 24-hour monitoring Starting situation: ■ The monitor should be disconnected from the PC. ® Step Mobil-O-Graph ► Put the monitor on the patient (put on the cuff and connect it to the recorder). ®...
4. Hypertension Management Software Client-Server ® Read out measurements from 24-hour monitoring session from Mobil-O-Graph Starting situation: ■ Monitor is connected to the PC, ® ■ Mobil-O-Graph is switched on, ■ PC is switched on, ® ■ Mobil-O-Graph interface recognises HMS CS. ®...
If you are interested in telemonitoring or require further information regarding practice monitoring, you can obtain this from your specialist dealer or directly from IEM GmbH. Protocol 11 activates the additional pulse wave analysis. The intervals for blood pressure monitoring and pulse wave analysis can be configured independently.
4.8.2 4. Hypertension Management Software Client-Server 4.8.2 Setting the monitor’s clock Import the time on the PC into the monitor. ► Click ► Confirm with The monitor shows the imported time. 4.8.3 Importing a patient ID You can save the Patient ID of the selected patient in the monitor. Later, when you import the 24-hour meas- urements, HMS CS will automatically recognise the patient.
4. Hypertension Management Software Client-Server 4.8.7 The time and type of reminder are imported from the monitor and displayed. Setting the type of reminder The monitor is able to remind the patient to measure BP in two ways: ■ By flashing light ■...
4. Hypertension Management Software Client-Server 4.9 Reading out measurements from the monitor You can transmit data from the monitor to HMS CS. Depending on the monitor, it will run through the following steps: ® ■ Mobil-O-Graph ® - End 24-hour monitoring, see 4.9.1, Ending 24-hour monitoring with the Mobil-O-Graph ®...
4. Hypertension Management Software Client-Server 4.9.5 ► If necessary, change the times of daytime and night intervals. ► Type in a report. ► Click The measurements transmitted are displayed as a table of measurements (see 4.11.1, Table of measurements). 4.9.5 Exporting measurements You can save measurements from a 24-hour monitoring session, which you have imported from a monitor into HMS CS and analysed, in a file.
4.10 4. Hypertension Management Software Client-Server 4.10 Using the Stabil-O-Graph ® (optional) ® The IR-Med infrared interface enables wireless data transmission between the Stabil-O-Graph NG monitor and the PC. The IR-Med infrared interface is connected to the PC by cable: ■...
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4. Hypertension Management Software Client-Server 4.10 ® Configuring interface between Stabil-O-Graph and HMS CS Starting situation: ■ Monitor is connected to the PC, ® ■ Stabil-O-Graph is switched on, ■ PC is switched on. ® Step Stabil-O-Graph ► Start HMS CS. If the program is set up for this, the window Patient list will appear (see 4.12.7, Extras).
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4.10 4. Hypertension Management Software Client-Server Start measurement Starting situation: ■ The monitor should be disconnected from the PC. ® Step Stabil-O-Graph ► Put the monitor on the patient (put on the cuff and connect it to the recorder). ► Press any key. The time and date are displayed.
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4. Hypertension Management Software Client-Server 4.10 ® Read out measurements from Stabil-O-Graph Starting situation: ■ Monitor is connected to the PC, ® ■ Stabil-O-Graph is switched on, ■ PC is switched on, ® ■ HMS CS recognises the interface for Stabil-O-Graph ®...
4. Hypertension Management Software Client-Server 4.11 4.11 Analysing measurements Starting situation: You have already read out measurements from the recorder and saved them in HMS CS (see 4.9, Reading out measurements from the recorder). The following analyses and functions are available for analysing measurements: Tab header Analysis Table of measurements, see 4.11.1, Table of measurements...
4.11.1 4. Hypertension Management Software Client-Server The window Measurement series appears. ► Type in your report. ► To accept the report, double-click The window disappears. 4.11.1 Table of measurements The table of measurements lists all measurements in a measurements series as a table. ►...
4. Hypertension Management Software Client-Server 4.11.2 The left-hand y-axis with the units mmHg applies to systolic, diastolic and mean values (BP values). The right-hand y-axis with the units 1/min applies to heart rate. The x-axis applies to time. The four daily intervals are highlighted. Day counts all three daytime intervals togeth- er.
4.11.4 4. Hypertension Management Software Client-Server The left-hand y-axis with the units mmHg applies to systolic, diastolic and mean values (BP values). The right-hand y-axis with the units 1/min applies to heart rate. The x-axis applies to time. The four daily intervals are highlighted. Day counts all three daytime intervals togeth- er.
4. Hypertension Management Software Client-Server 4.11.5 You can see the BP limits as horizontal (systolic) and vertical (diastolic) set-point curves. Note: You can set BP limits in the Patient information tab in the BP limits field. Show or hide daytime/night measurements ►...
4.11.7 4. Hypertension Management Software Client-Server Selecting measurements for calculation ► In the pop-up field, click below left on the required period for calculation (total, day, night). In the displays for day and for night, vertical lines indicate the BP limits. Note: You can set BP limits on the Patient information tab in the BP limits field.
4. Hypertension Management Software Client-Server 4.11.8 4.11.8 Hourly mean values This analysis lists all hourly mean values for blood pressure and pulse as a table. ► To display the hourly mean values, click on the tab Change basis for calculating hourly mean values ►...
4.11.10 4. Hypertension Management Software Client-Server The left-hand y-axis with the units mmHg applies to systolic, diastolic and mean values (BP values). The right-hand y-axis with the units mmHg/h applies to blood pressure change. The x-axis applies to time. The intervals for morning rise in blood pressure are highlighted. The lower, flattened curve shows the course of blood pressure.
4. Hypertension Management Software Client-Server 4.11.11 4.11.11 Comparing several measurement series If there are at least two measurement series stored for a patient, you can compare them. Depending on the analysis, ■ diagrams of the individual measurement series are shown one below the other, ■...
4.11.13 4. Hypertension Management Software Client-Server ► Click on the tab measured data to display a single PWA. ► In the measured data window click on a PWA value at the desired measuring. The pop-up window displays the PWA just like a PWA conducted at the doctor’s practice. 4.11.13 Bar chart (PWA) In the bar chart for PWA (pulse wave analysis) measurements with protocol 10 or protocol 11, the peripheral and central blood pressure readings are shown as a function of time.
4. Hypertension Management Software Client-Server 4.11.14 4.11.14 Patient report (Day Average) In the case of PWA measurements as part of 24h ABPM values, the patient report displays the average of select- ed haemodynamic information determined during the measurement period. In the case of PWA measurements in the doctor’s office, the patient report displays haemodynamic information determined from the single measurement.
4. Hypertension Management Software Client-Server Further information on the vascular age display: The vascular age of a patient is calculated based on the pulse wave velocity measured. In addition to the nor- mal age-related development of arterial stiffness in healthy people (green curve), measured in metres per sec- ond (m/s), there are also people who do not fit the normal pattern (red dot).
4.12.2 4. Hypertension Management Software Client-Server In the export settings window you can specify which data will be transferred to the e-health server and if the- se will be anonymized. If the anonymize box is checked, then only the patient ID is used ►...
4. Hypertension Management Software Client-Server 4.13 ► Click on export patient ► The export window appears ► Click on yes Already opened patients can also be exported using the symbol and synchronized using the symbol. After the import or export of patients, the patients authorized for e-health are marked with a small in the patient list and thereby authorized for synchronization with the e-health server.
4.13.2 4. Hypertension Management Software Client-Server 4.13.2 Assign received test series ► After the first measurement the symbol appears in the symbol list. Click on this symbol. ► The practice monitoring window appears ► Click on assign ► The selection window appears ►...
4. Hypertension Management Software Client-Server 4.14.2 4.14.2 Carry out pulse wave analysis The pulse wave analysis is in practice carried out via the Bluetooth interface or the IR interface of the ® Mobil-O-Graph . If you have previously only worked with a cable interface, please follow the instructions in section 4.7.2 Connection via Bluetooth or 4.7.3 Connection via Infrared (IR) for the configuration of the interface.
4.14.5 4. Hypertension Management Software Client-Server Preparing the Mobil-O-Graph ® with integrated 24h-PWA with protocol 11 starts a regular blood pressure measurement at the preset intervals. After measuring blood pressure, a PWA is carried out as well, by re-infla- ting the device and recording the pulse at the diastolic pressure. The 24h-PWA measurement identifies patients suspected of having LVH (left ventricular hypertrophy) and cor- relates with the actual physiological aortic systolic blood pressure.
(see 4.14.8, GDT settings) and the start of the HMS_GDT.EXE in the program directory you will find a new symbol next to the IEM Logo in the upper right corner: In this mode patient lists cannot be selected. The patient, who is transferred to the practice software, is active.
► You can enter the observation mode by clicking the symbol right next to the IEM Logo. The software is then minimized and waits for incoming GDT files in the background. As soon as a file is found, the software starts automatically with the patient.
4. Hypertension Management Software Client-Server 4.16.3 ► In the pop-up field, click the required language. ► Click The window disappears. Important! For the new language to become active, you must quit HMS CS and restart it. 4.16.3 e-health service Here the access to the e-health server is configured. ►...
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4 4 .16.4 4. Hypertension Management Software Client-Server Setting serial/IR/USB interface for a monitor ► In the Serial/IR/USB tab, click The window Connection with device appears. To search for a device, ► switch on the monitor. ► Click The device found is displayed in the pop-up list Interface. If no device is found, a message to this effect appears.
4. Hypertension Management Software Client-Server 4.16.5 Delete a monitor from the list ► Click the interface of the monitor you want to delete ► Click ► Confirm with The device disappears from the list. Secure interface To accept the details you have set, ►...
4.16.6 4. Hypertension Management Software Client-Server ► Type in the required limits. ► To accept the new limits, click The window disappears. 4.16.6 Analysis Here you can select different settings for the analysis. ■ Initial: Additional start interval to the four day-time intervals ■...
4. Hypertension Management Software Client-Server 4.16.8 ► Click The window disappears. 4.16.8 Extras Here you can set standard procedures for: ■ Calculation of mean (of all single measurements or the hourly mean values (HM) ■ Calculation of mean arterial pressure (measured MAP or calculated MAP) ■...
4.16.10 4. Hypertension Management Software Client-Server ► In the field Practice IT system -> HMS Client-Server enter the name of the GDT file that will be exporting pati- ent data from your practice’s system to the HMS CS. The same name must be set in both the HMS CS and the practice’s system.
5. Care and maintenance ® To ensure lasting optimal functionality of your Mobil-O-Graph , regular care and maintenance of the unit is nec- essary. Cleaning and disinfection The user (doctor) decides, whether and when disinfection of the cuff sleeve is necessary for reasons of hygiene (e.g.
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5. Care and maintenance Every 2 years As evidence of continuing to comply with the essential requirements of Directive ® 93/42/EEC, the Mobil-O-Graph monitor must be subject to metrological checks every two years. In some countries, this requirement may be the subject of nation- al laws or regulations.
The biennial calibration has not od of time without power supply been performed. Send the device for calibration through accumulators or batteries to your dealer or directly to IEM The buffer battery is changed at GmbH. the metrological check. The measurement data can no...
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6. Troubleshooting 6.5.1 Error symptom Possible cause Remedy The connection from the Mobil-O- 1. The incorrect COM interface is 1. Set the correct interface in the ® Graph to the PC is faulty. set. utilities program. 2. The cable plug or port is defec- 2.
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1. Serious fault due to pressure Send the unit without delay to your key is pressed build-up outside the meas- dealer or directly to IEM GmbH for urement process (pump has checking and repair switched on illegally) 2. These error messages all indi- cate a serious error in the pro- gram code.
2. Replace the batteries 3. Display defective 3. Send the unit for repair to your specialist dealer or directly to IEM GmbH. A fault occurs during the first meas- The cuff does not fit the upper arm Using the tape measure supplied, urement.
6.5.3 6. Troubleshooting 6.5.3 Communication errors, Mobil-O-Graph® Bluetooth interface Error Possible cause Remedy ® Code 1 Mobil-O-Graph Bluetooth interface Send the unit to your deal- has not started up correctly. er or directly to I.E.M. GmbH for checking. Possible hardware error. ®...
7. Charging units A common reason for reduced battery life is incorrect charging. If these batteries are used incorrectly, they lose ® capacity and are no longer able to supply the Mobil-O-Graph with power for 24 hours. Should the batteries have lost their charge during storage, please recharge accordingly.
7. Charging units If you leave a battery in the unit, it will be trickle charged so that the battery does not discharge. If you do not use the unit for some time, remove the plug from the power supply. Because of the unit's high charging current (950 mA for AA and 500 mA for AAA), it should be used only for high- quality rechargeable batteries >1000 mAh (AA) and >500 mAh (AAA).
8. Guarantee and repair conditions Guarantee: I.E.M. provides a two-year guarantee on the hardware, that is, the actual ABP monitor. The guarantee becomes invalid if the unit has been opened, incorrectly used or damaged deliber- ately or as a result of negligence. The guarantee also becomes invalid if the equipment has been repaired by an unauthorised person.
9. Appendix 9.1 EMC guidelines and manufacturer’s declaration Guidelines and manufacturer’s declaration - electromagnetic emissions ® The Mobil-O-Graph blood pressure monitor is intended for use in the environment specified below. The pur- ® chaser or user of the Mobil-O-Graph blood pressure monitor should ensure that it is used in such an environ- ment.
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9. Appendix Guidelines and manufacturer’s declaration - electromagnetic immunity ® The Mobil-O-Graph blood pressure monitor is intended for use in the environment specified below. The pur- ® chaser or user of the Mobil-O-Graph blood pressure monitor should ensure that it is used in such an environ- ment.
Form to copy 9.2 Important instructions for the patient ■ The beep signals a measurement. Keep still during the measurement until the process is complete. Let your arm hang loosely or, when sitting, let your lower arm rest on the table or on a support. Avoid moving your hand during the measurement.
Form to copy 9.3 Accessories order form Mobil-O-Graph ® ABP monitor Mobil-O-Graph - The 24h blood pressure monitor ® Practice: Dealer’s stamp: Street: Postcode/town: Tel.: Fax: Please give full address! Please provide a quotation for the following items I wish to order the following items Item Number Cuff S (20-24 cm)
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