Mobil-O-Graph Operating Instructions Rev 4.6 Oct 2011

Copyright© Mobil-O-Graph® Revision 4.6 08/2011 I.E.M. GmbH All rights reserved. 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 D-52222 Stolberg Tel.: + 49 02402 - 9500 0 Fax: + 49 02402 - 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... 9 2.5 Important instructions for the doctor ... 9 2.6 Important instructions for the patient ... 10 3. Product description... 11 3.1 Introduction... 11 3.2 Unpacking... 11 3.3 The monitor... 11

3.4

3.5 3.6

3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6

Keys...11 Display... 12 Acoustic signals... 12 Cuff connection... 12 Data port... 12 Infrared interface... 13

3.4.1 3.4.2 3.4.3 3.4.4 3.4.5 3.4.6

Switching on... 13 Clearing the memory... 13 Setting the time/date... 13 Transmitting patient data (ID)... 13 Specifying the measurement protocol required... 13 Putting on the monitor and starting measurement... 14

4.2.1 4.2.2 4.2.3 4.2.4

System requirements... 18 Installation for Windows® ... 19 Installation for Macintosh® OS 10.4 and later... 19 Installation for Linux... 20

4.4.1 4.4.2 4.4.3

Menu bar... 21 Toolbar... 22 Using the mouse... 22

4.5.1 4.5.2 4.5.3

Displaying sample patient... 23 Displaying sample patient’s data... 23 Quitting HMS CS... 24

4.6.1 4.6.2 4.6.3 4.6.4 4.6.5 4.6.6 4.6.7 4.6.8

Entering new patient... 24 Selecting existing patient... 25 Supplementing or modifying patient data... 26 Changing patient ID number... 26 Blood Pressure Limits... 26 Deleting a patient... 27 Enter office measurements BP... 27 Enter office measurements weight... 27

Preparing for monitoring... 13

Technical data... 15 Symbols...16 4. Hypertension Management Software client/server®... 17 4.1 Using HMS CS...17 4.2 Installing the software... 18

4.3 4.4

Starting and quitting HMS CS... 20 Structure of HMS CS user interface... 20

4.5

First steps with a sample patient... 22

4.6

Editing patient data...24

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Contents 4.6.9

Audit trail... 28

4.7.1 4.7.2 4.7.3

Connection via cable... 28 Connection via Bluetooth® ... 31 Connection via infrared (IR)... 35

4.8.1 4.8.2 4.8.3 4.8.4 4.8.5 4.8.6 4.8.7 4.8.8 4.8.9

Setting the measurement protocol... 39 Setting the monitor’s clock... 40 Importing a patient ID... 40 Testing the monitor... 40 Deleting old measurements... 40 Setting reminder times... 40 Ending device preparation... 41 Starting 24-hour monitoring with the Mobil-O-Graph®... 41 Starting measurement with the Stabil-O-Graph®... 41

4.9.1 4.9.2 4.9.3 4.9.4 4.9.5

Ending 24-hour monitoring with the Mobil-O-Graph®... 42 Connecting HMS CS to the Mobil-O-Graph®... 42 Connecting HMS CS to the Stabil-O-Graph®... 42 Importing measurements from monitor into HMS CS... 42 Exporting measurements... 43

4.7

Using the Mobil-O-Graph® blood pressure monitor... 28

4.8

Preparing the monitor...38

4.9

Reading out measurements from the monitor... 42

4.10 Using the Stabil-O-Graph® (optional)... 44 4.11 Analysing measurements... 49

4.11.1 Table of measurements... 50 4.11.2 Blood Pressure Profile (trend)... 50 4.11.3 Profile... 51 4.11.4 Correlation... 52 4.11.5 Values above limit... 53 4.11.6 Frequency distributions... 53 4.11.7 Report... 54 4.11.8 Hourly mean values... 55 4.11.9 Changes in blood pressure... 55 4.11.10 Printing... 56 4.11.11 Comparing several measurement series... 56 4.11.12 24h-PWA... 57

4.12 e-health...58 4.12.1 4.12.2 4.12.3

Activate e-health service... 58 Import Patients from e-health server ... 59 Export Patients to e-health Server ... 59

4.13.1 4.13.2

Prepare Mobil-O-Graph® for the practice monitoring... 60 Assign received test series... 60

4.14.1 4.14.2 4.14.3 4.14.4 4.14.5

Installation of the PWA at the doctor’s practice... 61 Carry out pulse wave analysis... 61 Activating the 24h-PWA... 62 Reading and Analysing the 24h-PWA... 62 Display of Pulse Wave Analysis... 62

4.15.1

Transfer Analysis Reports to Practice Software... 63

4.16.1 4.16.2 4.16.3 4.16.4 4.16.5 4.16.6 4.16.7 4.16.8 4.16.9

Database... 64 Changing language... 64 e-health service... 65 Interfaces... 65 Setting BP limits... 67 Analysis... 68 Setting colours for curves and background in graphs... 68 Extras... 68 GDT settings... 69

4.13 Practice Monitoring...60 4.14 Pulse Wave Analysis (PWA)... 61

4.15 GDT-Interface...63 4.16 Setting standard values for HMS CS... 64

5. Care and maintenance...71

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Contents 6. Troubleshooting...73 6.1 Principal sources of error... 73 6.2 Battery voltage curve...73 6.3 Transmission errors...73 6.4 Check list... 73 6.5 Error tables... 73 6.5.1 6.5.2 6.5.3

Troubleshooting, Mobil-O-Graph® ... 73 Communication errors, Stabil-O-Graph® ... 76 Communication errors, Mobil-O-Graph® Bluetooth interface ... 76

7. Charging units... 79 7.1 M2X...79 7.2 TL 4+4 Ultrafast Charger... 80 7.3 Operation with alkaline batteries... 80 8. Guarantee and repair conditions... 81 9. Appendix...83 9.1 EMC guidelines and manufacturer’s declaration... 83 9.2 Important instructions for the patient... 85 9.3 Accessories order form Mobil-O-Graph NG® ... 86 9.4 Blood pressure self-monitoring device order form... 87

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1. Introduction 1.1 Foreword This Mobil-O-Graph® 24-hour Ambulatory Blood Pressure Monitor system (ABPM) provides you with a system using the latest specialist technology, which incorporates all our experience of the past few years with the successful Mobil-O-Graph® ABP monitor. We have also incorporated our customers' wishes into the Mobil-O-Graph®. The blood pressure monitor, also referred to below as ABP monitor or recorder, can be prepared for a new patient in practice in just a few minutes. This gives you the advantage of using the ABP monitor optimally, and the ability to complete a whole monitoring session each day. The Mobil-O-Graph® will thus quickly be integrated into the daily routine of the practice. Clinical experience has shown that in addition to the ABPM, analysis of BP self-measurement is also sensible. The client/server data management extension enables a virtual patient clinic to be established.

1.2 Operating Instructions These operating instructions will show you quickly and simply how to use the ABP monitoring system and its accessories. With a little practice you will see how easy it is to use the ambulatory blood pressure monitor. For the analysis of the Mobil-O-Graph® the Hypertension-Management-Software Client-Server® data management is used. Where reference is made to specific characteristics, only those sections relating to your version are relevant! Important: The operating instructions describe the ABP monitor and its accessories in the sequence in which you will be setting up the equipment and then using it. After the general description you will find details of installation, setting up, preparation for monitoring, fitting to the patient and evaluation. The individual functions are explained later, at the point at which they are to be used. You will therefore become familiar with use of the blood pressure monitor step by step. The user should always have the operating instructions at hand.

1.3 Clinical tests The Mobil-O-Graph® blood pressure monitor fulfils the requirements of the ESH (European Society of Hypertension). Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic or automated Sphygmomanometers.

1.4 CE mark The Mobil-O-Graph® fulfils the requirements of the Medical Products Directive 93/42/EEC and bears the CE mark. The Mobil-O-Graph® fulfils the requirements of the 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. EN 1060-1 Noninvasive blood pressure measuring equipment - Part 1: General requirements 2. EN 1060-3 Noninvasive blood pressure measuring equipment - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems

1.5 Scope of delivery Basic set 1. Mobil-O-Graph® (NG or 24h PWA) 2. S-, M- and L-Cuff 3. Mobil-O-Graph® Universal Case 4. Recharger including 4 NiMH batteries 5. Operating Manual 6. Measuring tape 7. Event protocol

Analysis options: Analysis unit HMS Client-Server 1. HMS Client-Server on CD 2. Bluetooth-Dongle alternatively 3. IR-MED serial or USB alternatively 4. PC hybrid cable USB or serial

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2. Operating instructions 2.1 Intended use The appropriate use is 24-hour blood pressure monitoring and pulse wave analysis (PWA). The Mobil-O-Graph® should be used only under medical supervision.

2.2 Incorrect use Because of the risk of strangulation from the tube and cuff, the ABPM System Mobil-O-Graph® may not be used for patients who are legally incompetent nor for unattended children. The Mobil-O-Graph® is not designed for the application in neonates and children under the age of 3. The Mobil-O-Graph® must not be used for blood pressure monitoring during surgeries. It has not been designed for alarm-giving monitoring in intensive care units.

2.3

Indication The Mobil-O-Graph® ABPM system is intended for clarifying blood pressure and for use as a diagnostic aid. The doctor can, at his or her own discretion, prescribe the use of this medical system for patients if they are suffering from: ■■hypertension, ■■hypotension, ■■borderline hypertrophy, ■■impaired renal function, or ■■require antihypertensive therapy.

2.4

Side effects of 24-hour blood pressure monitoring 24-hour blood pressure monitoring is now a familiar, acceptable and valuable method of measurement, used daily in diagnostic investigation and treatment follow-up. When considering the use of 24-hour blood pressure monitoring, it is important to check whether the patient is suffering from coagulation disorders or is on anticoagulant treatment. As with occasional blood pressure measurement, petechial bleeding can occur. In patients on anticoagulant therapy or patients with coagulation disorders, petechial bleeding can occur on the measurement arm in spite of correct cuff fit. The special risk to patients due to anticoagulant treatment or coagulation disorders is present in all cases irrespective of the type of equipment used in measurement.

2.5

Important instructions for the doctor ■■A measurement can be stopped at any time by pressing one of the monitor keys. This deflates the cuff. ■■Tell your patients that, if a measurement should ever become painful, they should switch off the unit and take off the cuff. ■■Explain to the patient how to place the cuff correctly. ■■The equipment must not be used in the vicinity of an MRI scanner! ■■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. ■■The air tube between the Mobil-O-Graph® recorder and the cuff must never be knotted, compressed or stretched. ■■Observe the hygiene rules shown in the maintenance schedule. ■■Attention: Due to the risk of strangulation with the tube and cuff, the ABPM system must only be applied in children with special care and under the permanent supervision after specific prescription by the doctor. ■■Please note that for the application of the pulse wave analysis in children there are currently no clinical studies available against reference methods. ■■The pulse wave analysis provides additional indicators for possible risks, but is not admissible or valid as a sufficient indicator for single diseases or therapy recommendations. Warnings: ■■The shoulder strap or cuff tube can become entangled around the patient’s neck and lead to strangulation.

Countermeasures:

The doctor should draw the patient’s attention to the fact that the cuff must be worn on the upper 9

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2. Operating instructions

2.6

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. The air tube should therefore always be worn under the outer clothing (even at night). ■■If you suspect that water may have entered the unit during cleaning or use of the equipment, the device may no longer be used on the patient. Inform your service engineer without delay or send it for testing. ■■The air tube may kink when inflated. The doctor should explain to the patient that, particularly when sleeping, the equipment should be positioned in such a way that the tube cannot be compressed. If the patient is not fully competent, the equipment should be worn only under supervision. ■■In some patients petechiae, haemorrhages or subcutaneous haematomas may occur. All patients must be told when putting on the cuff that if they experience pain they should switch off the equipment and inform the doctor. ■■The doctor must be certain that, according to the health of the patient, the use of the device will not damage blood circulation in the arm. ■■The Mobil-O-Graph® is not suitable for use at the same time as high-frequency surgical equipment. ■■The Mobil-O-Graph® fulfils the requirements of EMC standards; nevertheless, the Mobil-O-Graph® should not be exposed to strong electromagnetic fields, as outside the limits they may cause malfunction. ■■The cuffs and the tube are made of electrically nonconductive material. They thus protect the device from the effects of a defibrillator discharge. ■■During a defibrillator discharge the device must not be allowed to touch the patient. The device may be damaged by such a discharge and give inaccurate measurements. ■■The device may not meet its performance specifications if stored or used outside the specified temperature and humidity ranges (see section 3.5) ■■In the majority of all cases the device is able to function according to specifications in the presence of common arrhythmias such as atrial or ventricular premature beats. In the condition of atrial fibrillation, the device may not be able to function to its specifications. ■■Caution: Substitution of a component different from that supplied might result in measurement error.

2.6

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. ■■The Start key triggers an additional measurement. Press this key only if instructed to do so by your doctor (e.g. after taking medication, if you have chest pains or shortness of breath etc.).

■■The Event key records the time of an event and triggers a measurement. Press this key only if something important or unusual is happening. ■■The Day/Night key

should be pressed immediately before going to sleep and upon waking.

■■The ON/OFF key permits the device to be switched on and off if a measurement is not required at the set time. To switch off, press the key for longer than 2 seconds. ■■A measurement can be interrupted at any time by pressing any of the keys. This deflates the cuff. Warnings: ■■The cuff may only be worn on the upper arm and in every case you should ensure that neither the shoulder strap nor the air tube can ever become wrapped around your neck. The air tube should therefore always be worn under the outer clothing (even at night). ■■Take care to ensure that the tube of the cuff cannot be kinked or compressed, particularly while sleeping. ■■If the measurement causes you pain, switch off the device, take off the cuff and inform your doctor. ■■The blood pressure monitor must not come into contact with liquids. Do not wear the equipment in the shower! If, for example, water has entered the device, it may no longer be used. Switch off the device and take out the batteries. ■■Serious malfunctions are indicated by a continuous beep. If a continuous beep sounds, switch off the device, take off the cuff and inform your doctor. ■■The cuff connection (air connector) must always engage with an audible click. Otherwise there will be a leaky connection between the Mobil-O-Graph® and the tube that will produce incorrect measurements. You can find a form to copy and give to the patient in the Appendix! 10

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3. Product description 3.1

Introduction The Mobil-O-Graph® system consists of two principal components: ■■the Mobil-O-Graph NG Classic® or Mobil-O-Graph® 24h-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 (either: HMS client/server HMS for Windows). Using this software, saved measurements can be downloaded to a PC, presented on the screen in various forms, as diagrams, lists and statistics, and printed out. The Mobil-O-Graph® can then be prepared immediately for the next patient. With a little practice, this procedure can be completed in just a few minutes. This allows the doctor to use the equipment on each working day, around the clock. The Mobil-O-Graph® monitoring system is designed to allow recording and display of a blood pressure profile throughout the day and night. Additional parameters are detected, such as nocturnal values and blood pressure variations. This allows the doctor to prescribe the optimum medication for the individual and to monitor the therapeutic outcome.

3.2

Unpacking All parts supplied are packed carefully for dispatch and checked for completeness and correct function. Should the goods supplied be incomplete or damaged, please notify the supplier without delay.

3.3

The monitor Components: 1: Cuff tube/air connector 2: Cuff connection 3: START key 4: DAY/NIGHT key 5: EVENT key 6: ON/OFF key 7: LCD display 8: Infrared interface 9: Battery compartment cover 10: Battery compartment 11: PC interface cable 12: Data port 13: Bluetooth interface (not visible)

Figure 3.1 Monitor, top view 3.3.1

Keys All keys are located on the front of the recorder housing (see Figure 3.1 Monitor, top view). ON/OFF

This key switches the ABP recorder on and off. To prevent switching it on or off by mistake, the key reacts only after 2 seconds. As with all the other keys, blood pressure measurement can also be interrupted prematurely, causing the pressure in the cuff to be released rapidly (see also the section Warnings). Caution: Switch the unit on again to continue.

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3. Product description DAY/NIGHT

3.3.2

The DAY/NIGHT key allows waking and sleeping phases to be differentiated when recording, which is important from the point of view of statistical evaluation and graphic presentation. For precise details of the effects on the printout, please see the relevant sections on analysis. Briefly: the patient is instructed to operate the “DAY/NIGHT” key on going to bed and again when getting up in the morning. This adjusts the monitoring interval to suit the individual patient and helps you in assessing the BP profile. As well as adjusting the interval, the appropriate notes are shown on the printout. If this key is not operated, the change in interval will take place according to the protocol selected.

EVENT

This key allows the patient to record the time at which medication is taken or any events happen that may cause blood pressure to rise or fall. Pressing this key directly triggers a measurement. The patient should note the reason for pressing the Event key in the events diary.

START

This key starts the 24-hour measurement period and also allows a measurement outside the pre-set measurement cycle. Caution: The result of the first measurement should be checked by the doctor for plausibility, to ensure that the subsequent automatic measurements are correct, and that the cuff fits properly. If the measurement is incorrect, the instructions in the sections Preparing for monitoring and Troubleshooting should be followed. When the Start key is pressed, the number of measurements recorded so far is displayed and manual measurement begins. This differs from automatic measurement according to the monitoring protocol, in that the cuff is inflated in stages. This determines the cuff pressure required to allow the systolic blood pressure to be measured. This maximum inflation pressure is stored and is then approached immediately by direct inflation for the subsequent automatic measurements. The patient can use the Start key to take manual measurements in addition to the pre-set measurement cycle.

3.3.2

Display The LCD display is located on the front of the recorder housing (see Figure 3.1 Monitor, top view). It displays useful information for the doctor and patient on measurement data, monitor settings and measurement errors.

3.3.3

Acoustic signals The acoustic signals used consist of single or multiple beeps. The following signals are emitted:

3.3.4

1 beep

Switching on or off, start and completion of a measurement (except for night intervals), removal of interface cable, end of IR communication, set-up and end of Bluetooth communication, and measuring error

3 beeps

System error

Continuous beep

Serious system error (e.g. cuff pressure is greater than 15 mmHg for more than 10 seconds outside of a measurement)

Combined beeps

When deleting measurements manually, first one beep is emitted and 2 seconds later 5 beeps.

Cuff connection The cuff connection is fitted on the front of the recorder housing (see Figure 3.1 Monitor, top view). This metal plug is used to connect the recorder with the cuff via the cuff tube and the metal cuff socket. Important: Both the doctor and the patient should be aware that the metal plug (air connector) must always engage with an audible click. Otherwise there will be a leaky connection between the Mobil-O-Graph® and the tube that will produce incorrect measurements.

3.3.5

Data port The data port is located on the left-hand side of the housing (see Figure 3.1 Monitor, top view). The connector cable supplied goes into this socket. This is a plug-in connection, i.e. the red dot on the plug must be aligned with the red dot on the socket. To disconnect, pull on the outer metal ring of the plug (see section: The analysis unit).

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3.3.6 3.3.6

3. Product description 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 section: The analysis unit).

3.4

Preparing for monitoring

■■Connect the cuff tube with one of the cuffs supplied, by pushing it onto the plastic connector. ■■Connect the cuff tube with the socket on the front of the recorder housing. ■■First check that the batteries have been inserted correctly. You should always use fully charged batteries for a new monitoring session. Alternatively, you can use alkaline batteries. Take care to insert the batteries the right way round. Important: Use only the I.E.M. NiMH rechargeable batteries supplied or alkaline batteries. Although zinc-carbon batteries and NiCd rechargeables show adequate voltage in the battery test, the output is often insufficient to carry out monitoring over a 24-hour period. The rechargeable batteries should be discharged and recharged several times before they are first used. Please follow the instructions for use enclosed with the charging unit. To perform monitoring over a 48-hour period, you need 2 additional batteries to exchange after 24 hours.

3.4.1

Switching on Always check the condition of your recorder first, before you give it to a patient. You can do this by observing the initial displays shown on the recorder shortly after switching it on. The following sequence of displays should appear: Test

Display

Commentary

Battery status (Volts)

2.85

(for NiMH rechargeable batteries min. 2.75; for alkaline batteries min. 3.10)

Display Segment Test

999:999 to 000:000

Along with the numbers, all the other LCD symbols are shown.

21:45

(Example)

Current 24-hour time

Check whether all segments are being shown correctly and completely (the complete code is constantly being checked for correctness in the background)

If a fault occurs during the internal test, the recorder shows E004 on the display and emits an acoustic signal. For safety reasons, use of the recorder is blocked. Return the recorder to your specialist dealer or directly to I.E.M. GmbH for repair without delay. 3.4.2

Clearing the memory The memory must be cleared before each monitoring session, i.e. no blood pressure data from the previous patient must be left in the memory. However, should values still be present, you can delete them with the delete function of the analysis software. You can delete the memory manually by pressing and holding down the start button for at least 5 seconds. While holding down, all segments of the LCD are highlighted followed by a single beep. Subsequently the number of the recordings is shown, followed by “clr”. If the event button is pressed within 5 seconds and held down for at least 2 seconds, all recordings will be deleted.

3.4.3

Setting the time/date The Mobil-O-Graph® has an internal buffer battery that allows the clock to continue running even after the batteries have been removed. You should nevertheless check the time and date before each measurement series. The time and date can be set with the analysis software. You can also set the time and date manually by holding the Start key and then pressing the Event key. Now you are in the “Set time” mode. Use the Start key to change the number in question, and use the Event key to jump to the next.

3.4.4

Transmitting patient data (ID) The Monitor must be prepared by transmitting the patient data (ID), so that measurements are allocated correctly when reading out (see 4.8.3, Importing a patient ID).

3.4.5

Specifying the measurement protocol required You have the option to select from eleven (1-11) protocols. Once you have completed one measurement, the protocol cannot be changed until deletion of all data has been completed. The protocols can be set using the analysis software.

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3. Product description

3.4.5

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 per hour

Acoustic signal

Measurements shown on display

1

08:00 00:00

23:59 07:59

4

YES

YES

2

NO

2

08:00 23:00

22:59 07:59

4

YES

1

NO

3

07:00 22:00

21:59 06:59

4

YES

2

NO

08:00 00:00

23:59 07:59

4

YES

2

NO

18:00 10:00

09:59 17:59

4 2

YES

07:00 00:00

23:59 06:59

4

YES

2

NO

7

06:00 23:00

22:59 05:59

4

YES

2

NO

8

07:00 09:00 00:00

08:59 23:59 06:59

6

YES

4

YES

2

NO

4 5 6

YES NO NO YES

NO YES NO YES

9

09:00

08:59

30

NO

10

08:00

07:59

30

YES

NO

11

08:00 00:00

23:59 07:59

4

YES

YES

2

NO

YES

Table 3.0 Protocol list Note:

Protocols 1, 2 and 10 are provided as defaults, but they can be modified using the analysis software (see 4.8, prepare measurement device). Protocol 5 is suitable for nighttime activity (night shift). Protocol 9 is the Schellong-test. Protocol 10 transmits the values automatically after each measurement to your doctor’s PC via Bluetooth, or to a database via mobile communications such as a mobile phone or modem (preconfigured by I.E.M.; see 4.8.1, Setting the measurement protocol). Only preconfigured mobile phones or modems can send the data via GPRS as a block of data. Protocol 11 is only available for the Mobil-O-Graph® with integrated 24-h-PWA and the HMS CS as of version 4.0. Here, the intervals for blood pressure monitoring and 24-h-PWA can be configured independently

3.4.6

Putting on the monitor and starting measurement Put the equipment pouch on the patient. By varying the length of the strap you can use it either as a hip belt or a shoulder strap. Alternatively, use a normal belt that matches the patient’s clothing. Now fit the cuff on the patient; correct cuff fit is extremely important for accurate measurement (see Figure 3.2). The cuff can also be worn over the shirt or blouse. We recommend that the cuff be fitted on the bare upper arm. In this case, bring the tube out between the buttons of the shirt or blouse, around the back of the neck to the ABP monitor on the right-hand side.

Figure 3.2 Putting on the cuff Please note the following points: 14

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3.5

3. Product description IMPORTANT: 1. When putting the recorder on the patient, the recorder must not be connected to other external equipment! 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. The air tube should allow free movement of the upper arm and should run over the back of the neck to the other side of the body. 3. It is essential to ensure that the artery symbol lies over the brachial artery. When the cuff fits correctly, the metal strip is on the outer side of the upper arm (elbow side). 4. The material loop must cover the skin under the metal strip. 5. The lower edge of the cuff should be about 2 cm above the bend of the patient’s elbow. 6. The cuff should fit relatively snugly on the upper arm. Correct fit can be checked by a simple test: there should be room to slip one finger under the cuff. 7. The correct cuff size is also important if blood pressure is to be measured correctly. To obtain reproduc­ ible results, standardised monitoring conditions are required, i.e. the cuff must be the correct size for the patient. Using the tape measure supplied, measure the circumference at the middle of the upper arm and select the appropriate cuff: Upper arm circumference

Cuff

20 - 24 cm

S

24 - 32 cm

M

32 - 38 cm

L

38 - 55 cm

XL

8. Connect the air tube from the cuff to the ABP recorder. Push the tube firmly over the connection until a click is heard as it engages; to disconnect, simply pull back the outer metal ring on the plug. 9. The recorder is now correctly fitted and ready for use. Once all these steps have been completed, the monitor can be started. First, a manual measurement must be carried out by pressing the “START” key. This measurement is used to determine whether the recorder is working correctly. If errors occur, check once more that the procedure followed in setting up and fitting the equipment was correct. Should this not solve the problem, repeat the setting-up procedure. Only after a successful manual measurement can the patient be allowed to leave with the equipment. Interrupting measurements During a measurement, ANY key can be used to interrupt the measurement. The display then shows “-StoP-” and beeps 5 times. The process is also saved in the table of measurements under “Interruption”. Important: Before beginning a 24-hour monitoring session, take the patient through Chapter 2: Operating instructions.

3.5

Technical data Pressure measurement range:

Systolic Diastolic

60 to 290 mmHg 30 to195 mmHg

Accuracy:

+/- 3 mmHg in the range indicated

Static pressure range:

0 to 300 mmHg

Pulse range:

30 to 240 beats per minute

Method:

oscillometric

Measurement intervals:

0, 1, 2, 4, 5, 6, 12 or 30 measurements per hour

Monitoring protocols:

2 modifiable interval groups

Storage capacity:

300 measurements

Battery capacity:

> 300 measurements

Operating temperatures:

+10 °C to +40 °C

Operating humidity:

15% to 90%

Storage environment:

-20 °C to 50 °C and 15% to 95% humidity

Dimensions:

128 x 75 x 30 mm

Weight:

approx. 240 g including batteries

Power supply:

2 NiMH batteries, each 1.2 V and at least 1500 mAh (AA, Mignon) 2 alkaline 1.5 V batteries (AA, Mignon)

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3. Product description Interfaces:

3.6

3.6 Serial (cable) Infrared IEM-specific Bluetooth (Class 1/100 m)

Symbols Battery symbol Meaning: The symbol shows the type of voltage.

Disposal of used electrical and electronic appliances Meaning: This symbol on a product or its packaging indicates that the product should not be treated as normal household waste, but must be returned to a recycling point for electrical and electronic appliances. You can obtain further information from your local authority, local waste disposal plants or specialist dealers. Defibrillator rating Meaning: BF applied part, defibrillator protected

Caution, consult accompanying documents Meaning: caution, consult accompanying documents

Manufacturing date Meaning: Date of manufacture

CE mark Meaning: The device fulfils the basic requirements of the European Directives on medical devices.

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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: ■■Personal patient ID number (mandatory entry) ■■Name (mandatory entry) ■■Address, telephone number ■■Personal data (age, sex etc.) ■■Medication, medical history, emergency contacts The HMS CS program offers you various options for analysis. You can choose to display the results on your screen or print them out directly as: ■■4.11.1, Table of measurements ■■Statistical analysis with mean blood pressure values for the whole day, and for the daytime and nighttime periods and the first hour after waking, plus hourly mean values, see 4.11.7, Report ■■Extreme values (maximum and minimum values), see 4.11.7, Report ■■Percentage incidence of values above a predetermined limit, see 4.11.7, Report ■■Standard deviation (variability), see 4.11.8, Hourly mean values ■■Calculation of day/night reduction, see 4.11.7, Report ■■Graphs such as: □□Envelope curve of hourly mean values, see 4.11.2, BP profile □□Correlation, see 4.11.4, Correlation □□Pie chart of percentage of values above limit, see 4.11.5, Values above limit □□Bar chart of measurements, see 4.11.6 Frequency distributions □□Curve of changes in blood pressure, see 4.11.9, Changes in blood pressure □□Curve of measurements, see 4.11.9, Changes in blood pressure □□Histogram of blood pressure distribution, see 4.11.9, Changes in blood pressure □□Curve comparison for optimising treatment, see 4.11.9, Changes in blood pressure In this way you can rapidly and simply visualise the course of and fluctuations in blood pressure over the day and night. You can adjust medication to take the best possible account of these changes. You can also enter measurements from the „Klock®” - the wrist blood pressure monitor - and the Stabil-O-Graph - the upper arm blood pressure monitor - and manage the data using the HMS CS program (see 4.11.3, Selfmeasurements). An infrared eye is required for data transfer. The HMS CS also provides the opportunity to establish an E-Health Service (telemedicine), with a significantly higher security for the patient, while saving work for the doctor. You can set limits, or define alarms that will only inform you if the limits you have set are exceeded (e.g. by Fax). The offers include blood pressure monitoring by the Stabil-O-graph mobil and weight monitoring with the scale mobil. In addition to an online database, you can use these devices to synchronise and manage data online with the HMS CS online. For further information, please contact your specialist dealer or I.E.M. GmbH directly.

4.1

Using HMS CS Basic knowledge and experience of the operating systems Windows®, Mac OS® or Linux® are required for using HMS CS. Use the HMS CS program to manage blood pressure monitoring data and evaluate them. You classify these measurements by patient. You can store as many measurement series as you like for each patient. Each measurement series consists of many single measurements. HMS CS will run through the following steps: ■■Before 24-hour monitoring: prepare measurement 1) Start HMS CS 2) Select patient or enter new patient 3) Connect monitor to HMS CS 17

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4.2

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. The following connections are possible: ■■Cable with serial interface (e.g. COM1,2...), ■■Combi cable with USB interface, ■■Infrared (IR) with serial interface, ■■Infrared (IR) with USB interface, ■■Bluetooth. Important: If you are using the USB interface and/or Bluetooth, you must first install the corresponding driver. You can find the details below. 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.

4.2.1

System requirements 1) Computer ■■1 GHz ■■512 MB RAM ■■100 MB hard disk storage ■■1024x768 pixels ■■Two spare USB ports 2) Operating system a) Windows 2000 SP4, XP, Vista b) Mac OS X 10.4 or later c) Linux (with Intel/AMD processors), GNU/Linux with BlueZ or Affix Bluetooth Stack 3) Software Java Runtime Environment (JRE is supplied with the installation CD) 4) Bluetooth ■■Bluetooth USB adaptor ■■Bluetooth 2.0 ■■USB Version 1.1 or higher ■■BlueSoleil driver or software must not be installed! ■■Tested USB adaptors: -- DIGITUS  Windows XP SP2: automatic installation with Microsoft Stack -- Gigabyte GN-BT03D  Windows XP SP2: automatic installation with Microsoft Stack -- ANYCOM USB-200 or USB 250 Blue USB adaptor  Windows XP, Windows XP SP2: installation of supplied driver for Windows XP Bluetooth Stack or installation of supplied Bluetooth software BTW  Windows 2000, XP, Mac OS X 10.4 or newer: Installation of supplied Bluetooth Software BTW  GNU/Linux 2.4, GNU/Linux 2.6 with BlueZ or Affix Bluetooth Stack: no installation necessary

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4. Hypertension Management Software client/server®

4.2.2 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: -- first Bluetooth driver, -- then USB driver. 3) Insert USB adaptor and/or Bluetooth adaptor into the computer. Installing the application from CD-ROM ►► Insert the CD into the CD-ROM drive. The installation program will normally start automatically. If it does not (autorun function has been switched off), □□open the CD-ROM drive in Windows Explorer and □□click the file CD_Start.exe, to start installation. ►► Select your language. ►► In the installation menu, click HMS-CS Setup. The installation wizard will appear.

►► Follow the instructions on the screen. Installing the Bluetooth driver Note: Please insert the Bluetooth adaptor only after installing the software onto your computer, or when prompted to do so. For the Bluetooth-Adapter DIGITUS (usable from Windows XP SP2 and higher) no driver software is needed. ►► In the installation menu, click Bluetooth driver ►► Follow the instructions on the screen. Installing USB driver Note: Please insert the USB adaptor (USB stick or cable with USB interface) only after installing the software onto your computer. ►► In the installation menu, click USB cable driver ►► Follow the instructions on the screen. Installation of the software is now complete. 4.2.3

Installation for Macintosh® OS 10.4 and later Procedure: 1) Install application from CD-ROM 2) Insert USB adaptor and/or Bluetooth adaptor into the computer. Installing application from CD-ROM ►► Insert the supplied CD into your CD-ROM drive. The CD symbol HMS CS appears on the desktop. ►► Double-click this CD symbol for HMS CS. The CD-ROM opens. ►► Open the directory Mac_10-4. ►► Drag the file HMS.app into your Applications folder. Installation of the software is now complete.

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4. Hypertension Management Software client/server® 4.2.4

4.3

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). ►► Place the CD supplied into your CD-ROM drive. ►► On the CD, open the Linux directory. ►► Copy the HMS CS folder into your Home directory. ►► Set the HMS CS file in the Home directory to executable. ►► Set up a link to the HMS file on your desktop. Software installation is now complete. On the installation CD, the “Docs” directory contains various documents (first steps, brief instructions, user manual). “index.htm” shows the available documents.

4.3

Starting and quitting HMS CS Basic knowledge and experience of the operating systems Windows®, Mac OS® or Linux® are required for using HMS CS.. Starting the program ►► On the desktop, double-click HMS CS starts up. Information about the progress of loading the program appears (e.g. program version, progress bar). Quitting the program ►► In the work window, in the toolbar at the top, click

.

If you have previously modified data, you will be asked if you want to save the data. Information about the progress of quitting appears.

4.4

Structure of HMS CS user interface You can access all functions from the control window. More windows may appear depending on the function.

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 information and Measurements. 20

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4.4.2 4.4.1

Menu bar At the top of the control window is the Menu bar.

Each menu item combines functions. ■■Menu File Menu item

Function

Patient list

Display list with existing patients

New Patient

Setup new patient

Import

Import of patient data (Abdm.mdb, GDT and patient)

Data back-up

Storing and restoring of database (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

Quit program

Quit HMS CS

■■Menu Patient Menu item

Function

Delete

Delete current patient, including all measurements, see 4.6.5, Deleting a patient

Export

Manual export of patient to the e-health database

Change ID

Change personal patient number of the currently modified patient, see 4.6.4, Change Personal Patient Number (Patient-ID)

Export Patient

Manual export of a patient to the e-health data base

Delete modification

Reverse modifications on a currently opened patient data base

■■Menu Measurement series Menu item

Function

Export (Excel)

save the currently selected test series in an Excel file, see 4.9.5, export test results

Export (XML)

save the currently selected test series in an XML file, see 4.9.5, export test results

Export (GDT)

save the currently selected test series in a GDT file, see 4.9.5, export test results

Delete

Delete selected measurement series

■■Menu Settings Note: for detailed information see 4.12, Setting standard values for HMS CS Menu item

Function

Database

Configuring database, only for experienced users!

Language

Setting the language of the program

e-Health service

Establishing connection to e-Health service

Interfaces

Setting interface for recorder

BP limits

Setting limits for analyses

Analysis

Specify settings for analysis

Colours

Setting colours for curves and background in graphs

Extras

Procedure for calculations, display and Bluetooth

GDT Settings

Specify file and folder settings for the GDT import/export

■■Menu ? Menu item

Function

About...

Display information about HMS CS version

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4. Hypertension Management Software client/server® 4.4.2

4.4.3

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. On the far right you will see the current patient’s name and date of birth.

Tip: If your mouse pointer hovers over a symbol, a brief explanatory text will appear (Tooltip). Symbol

Meaning

Function

New patient

Enter a new patient, see 4.6.1, Entering new patient

Patient list

Display list of existing patients, see 4.6.2, Selecting existing patient

Prepare device

Program recorder for the next 24-hour monitoring period

Read out device

Read out measurements from the recorder

Start PWA

A pulse wave analysis will be started in the Mobil-O-Graph®.

Bluetooth

red: Bluetooth not active green: Bluetooth active

e-health symbols

Export current patients to the e-health data base. Synchronize current patients with the e-health data base.

Quit program

Quit HMS CS

Practice Monitoring

Receive test series via the Practice Monitoring

Note: You can call up some of these functions via menu items in the Menu bar. 4.4.3

Using the mouse Click means: click the left mouse button once. Double-click: click the left mouse button briefly twice.

4.5

First steps with a sample patient Once you have successfully installed HMS CS, you can try out important functions using the sample patient John Doe. Basic knowledge and experience of the operating systems Windows®, Mac OS® or Linux® are required for using HMS CS. ►► On the desktop, double-click

.

HMS CS starts up. Information about the progress of loading the program appears (e.g. program version, progress bar).

The control window and the window Patient list appear.

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