Mobil-O-Graph NG Revision 1.5 Operating Instruction HMS for WINDOWS ver 7.x May 2007

Copyright© Mobil-O-Graph NG® Revision 1.5 05/2007 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 Tél.: +49 2402 - 9500 0 Fax: +49 2402 - 9500 11 email: iem.office@iem.de homepage: www.iem.de

CONTENTS

1. Introduction

TABLE OF CONTENTS

Foreword... 1.1 The operating instructions... 1.2 Clinical tests... 1.3 CE mark... 1.4 Scope of delivery... 1.5

2. Operating instructions

Correct use... 2.1 Incorrect use... 2.2 Indication... 2.3 Side effects of long-term blood pressure monitoring... 2.4 Important instructions for the doctor... 2.5 Important instructions for the patient... 2.6

3. Product description

Introduction... 3.1 Unpacking... 3.2 The monitor... 3.3

Keys... ...3.3.1 Display... 3.3.2 Acoustic signals... 3.3.2 Cuff connection... 3.3.3 Data port... 3.3.4 Infrared interface... 3.3.5

Preparing for monitoring... 3.4

Switching on... 3.4.1 Clearing the memory... 3.4.2 Setting the time/date... 3.4.3 Transmitting patient data... 3.4.4 Specifying the measurement protocol required... 3.4.5 Putting on the monitors and starting measurement... 3.4.6

Technical data... 3.5 Symbols... 3.6

4. Hypertension Management Software for Windows®

WINDOWS-Software - installation... 4.1 Installation in WINDOWS 95/ 98/ NT/ 2000... 4.1.1 Update installation... 4.1.2

Program structure... 4.2

Menu bar... 4.2.1 Toolbar... 4.2.2

Brief instructions... 4.3 The first steps... 4.4

Example... 4.4.1 Help... 4.4.2 Windows... 4.4.3 Closing the program... 4.4.4

Patient data... 4.5

Entering new patients in the database... 4.5.1 Loading stored patient data... 4.5.2 Exporting readings (ANSI file)... 4.5.3 Mobil-O-Graph NG® blood pressure monitor... 4.6 Preparing the monitor... 4.6.1 Downloading from the monitor after the 24-hour monitoring session... 4.6.2

Stabil-O-Graph (optional)... 4.7

Infrared data transmission using the “Stabil-O-Graph®”... 4.7.1 Preparing for monitoring... 4.7.2

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH

CONTENTS Analysis... 4.8

Profile display... 4.8.1 Histogram... 4.8.2 Table of measurements... 4.8.3 Report of findings (statistics)... 4.8.4 Comparing two series of measurements... 4.8.5 Hourly mean values... 4.8.6 Changes in blood pressure... 4.8.7 Correlation... 4.8.8 Comments... 4.8.9

Settings... 4.9

5. Care and maintenance 6. Troubleshooting

Principal sources of error... 6.1 Battery voltage curve... 6.2 Transmission errors... 6.3 Check list... 6.4 Error tables... 6.5

Troubleshooting, Mobil-O-Graph NG®. ... 6.5.1 Communication errors, Stabil-O-Graph®... 6.5.2

7. Charging units

M2X-I.E.M... 7.1 TL 4+4 Ultrafast Charger... 7.2 Operation with alkaline batteries... 7.3

8. Guarantee and repair conditions 9. Appendix

EMC guidance and manufacturer’s declaration ... 9.1 Master copy: Important instructions for the patient... 9.2 Master copy: Accessories order form Mobil-O-Graph®... 9.3 Master copy: Home blood pressure monitors order form... 9.4

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH

INTRODUCTION 1. EINFÜHRUNG

1

1. INTRODUCTION 1.1 Foreword

This Mobil-O-Graph NG® 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-OGraph® ABP monitor. We have also incorporated our customers’ wishes into the Mobil-O-Graph NG®. The blood pressure monitor, also referred to below as the ABP monitor or recorder, can be prepared for a new patient at the surgery 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 NG® will thus quickly be integrated into the daily routine of the practice. Clinical experience has shown that in addition to the ABPM, analysis of blood pressure self-monitoring is also sensible. The client/server data management extension enables a virtual patient clinic to be established.

1.2 The 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. The Mobil-O-Graph NG® is supplied by I.E.M. in two versions with different evaluation programs:

- Hypertension Management Software for Windows (from Version 7.0). 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.

1.3 Clinical tests

The Mobil-O-Graph NG® blood pressure monitor fulfils the requirements of the ESH (European Society of Hypertension).

1.4 CE mark

The Mobil-O-Graph NG® fulfils the requirements of the Medical Products Directive 93/42/EEC and bears the CE mark. The Mobil-O-Graph NG® 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. ABP monitor Mobil-O-Graph NG® 2. S , M und L Cuffs 3. Cuff tube, incl. connector 4. Pouch for Mobil-O-Graph NG® 5. Charger, incl. 4 NiMH batteries 6. Operating instructions 7. Measuring tape

Analysis options: Analysis unit HMS for Windows® 1. HMS software on CD 2. USB/serial PC cable 3. IR-MED serial or USB (optional)

I.E.M. GmbH, Mobil-O-Graph®, Bedienungsanleitung, Rev. November 2000 ® Mobil-O-Graph NG , Operating instructions, Rev. 1.5 05/2007, GmbH

2. OPERATING INSTRUCTIONS

2

2. Operating instructions 2.1 Correct use

The correct use is the 24-hour blood pressure monitoring of adults. The Mobil-O-Graph NG® 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 NG® may not be used for patients who are legally incompetent, and may not get into the hands of unsupervised children. The Mobil-O-Graph NG® may not be used for blood pressure monitoring in intensive care or during operations.

2.3 Indication

The Mobil-O-Graph NG® 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 long-term blood pressure monitoring

Long-term 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 long-term 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 broken off at any time by pressing one of the monitor keys. This deflates the cuff.

(except for the Day/Night key)  Inform 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 readings.  The air tube between the Mobil-O-Graph NG® recorder and the cuff must never be knotted, compressed or stretched.  Observe the hygiene rules shown in the maintenance schedule.

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 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, petechia, haemoralgias or subcutaneous haematomas are possible. 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 convinced that, according to the health of the patient, the use of the device will not damage blood circulation in the arm.

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH

2.4

2. OPERATING1. INSTRUCTIONS EINFÜHRUNG  The Mobil-O-Graph NG® is not suitable for use at the same time as high-frequency surgical equipment.  The Mobil-O-Graph NG® fulfils the requirements of EMC standards; nevertheless, the Mobil-O-Graph NG® 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 readings.

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

saves 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 desired

at the set time. To switch off, press the key for longer than 2 seconds.  A measurement can be broken off 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 NG® and the tube that will produce incorrect measurements. You can find a form to copy and give to the patient in the Appendix!

I.E.M. GmbH, Mobil-O-Graph®, Bedienungsanleitung, Rev. November 2000 ® Mobil-O-Graph NG , Operating instructions, Rev. 1.5 05/2007, GmbH

3

3. PRODUCT DESCRIPTION

3. Product description 3.1 Introduction

The Mobil-O-Graph NG® system consists of two principal components: Mobil-O-Graph NG® Basic set with various cuffs and further accessories Interpretation software for the doctor to evaluate the readings. Readings from the ABP monitor can be interpreted using the Analysis unit (either: HM Client software or HM Windows software). Using the software, saved readings 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 NG® can then be prepared immediately for the next patient. With 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 NG® monitoring system is designed to allow the 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 despatch 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 section Warnings). Caution: Switch the unit on again to continue.

DAY/NIGHT 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.

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH

3.3.3

3. PRODUCT DESCRIPTION

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 blood pressure 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 that may cause blood pressure to rise or fall. Pressing this key directly triggers a measurement. The reason for pressing the Event key should be noted by the patient 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.

3.3.3 Display The LCD display is located on the front of the recorder housing (see Figure 5.1 Monitor, top view). It displays useful information for the doctor and patient on measurement data, monitor settings and measurement errors. 3.3.4 Acoustic signals The acoustic signals used consist of single or multiple beeps. The following signals are emitted: 1 beep: 3 beeps: Permanent beep: Combined beeps:

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 System error Serious system error (e.g. cuff pressure is greater than 15 mmHg for more than 10 seconds outside of a measurement) For manual deletion of readings, first one beep is emitted and 2 seconds later 5 beeps.

3.3.5 Cuff connection The cuff connection is fitted on the front of the recorder housing (see Figure 5.1 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 NG® and the tube that will produce incorrect measurements.

3.3.6 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) 3.3.7 The 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)

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH

3.4

4. PRODUCT 3. PRODUKTBESCHREIBUNG DESCRIPTION 3.4 Preparing for monitoring Connect the cuff tube with one of the cuffs supplied by sticking 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 be visible: 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. Check whether all segments are being shown correctly and completely (the complete code is constantly being checked for correctness in the background)

Current 24-hour time:

21:45

(Example)

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 direct to IEM 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 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 NG® 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 series of measurements. The time and date can be set with the analysis software. You can also set the time and date manually by holding down 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 Transfer of patient ID The monitor has to be prepared with the transfer of the patient ID. This enables a clear assigment of the data to the correct patient. (Please also take a look at chapter 4.6.2 downloading)

I.E.M. GmbH, Mobil-O-Graph®, Bedienungsanleitung, Rev. November 2000 ® Mobil-O-Graph NG , Operating instructions, Rev. 1.5 05/2007, GmbH

3.4.5

4.3. PRODUKTBESCHREIBUNG PRODUCT DESCRIPTION

3.4.5 Specifying the measurement protocol required You can use the Protocol key to choose one of nine (1–9) 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. 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

Value shown on display

1

08:00 00:00

23:59 07:59

4 2

YES NO

YES

2

08:00 23:00

22:59 07:59

4 1

YES NO

YES

3

07:00 22:00

21:59 06:59

4 2

YES NO

NO

4

08:00 00:00

23:59 07:59

4 2

YES NO

NO

5

18:00 10:00

09:59 17:59

4 2

YES NO

YES

6

07:00 00:00

23:59 06:59

4 2

YES NO

YES

7

06:00 23:00

22:59 05:59

4 2

YES NO

NO

8

07:00 09:00

08:59 23:59

6 4

YES NO

YES

9

09:00

08:59

30

NO

YES

Table 3.0 Protocol list Note:

Protocols 1 and 2 are set as standard, but can be changed using the analysis software versions (see sections Analysis unit: Windows software, preparing the monitor). Protocol 5 is suitable for night-time activity (night shift). Protocol 9 is the Schellongtest.

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).

I.E.M. GmbH, Mobil-O-Graph®, Bedienungsanleitung, Rev. November 2000 ® Mobil-O-Graph NG , Operating instructions, Rev. 1.5 05/2007, GmbH

3.5

4. PRODUCT 3. PRODUKTBESCHREIBUNG DESCRIPTION Figure 3.2 Putting on the cuff 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 recorder on the right-hand side.

Please note the following points: 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 aspect 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 reproducible 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 20 - 24 cm 24 - 32 cm 32 - 38 cm 38 - 55 cm

Cuff S M L XL

7. 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. 8. 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 faults 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 results under “Interruption”. Important: Before beginning a 24-hour monitoring session, take the patient through section 2: Operating instructions.

3.5 Technical data Pressure measurement range: Accuracy: Static pressure range: Pulse range: Method: Measurement intervals: Monitoring protocols: Storage capacity: Battery capacity: Operating temperatures: Operating humidity: Storage environment: Dimensions: Weight: Power supply: Interfaces:

Systolic 60 to 290 mmHg Diastolic 30 to 195 mmHg +/- 3 mmHg in the range indicated 0 to 300 mmHg 30 to 240 beats per minute oscillometric 0, 1, 2, 4, 5, 6, 12 or 30 measurements per hour 2 modifiable interval groups 300 measurements > 300 measurements +10°C to +40°C 15% to 90% 20°C to 50°C and 15% to 95% humidity 128 x 75 x 30 mm approx. 240 g including batteries 2 NiMH batteries, each 1.2 V and at least 1500mAh (AA, Mignon) 2 alkaline 1.5 V batteries (AA, Mignon) Serial (cable) Infrared IEM-specific Bluetooth (Class 1/100 m

I.E.M. GmbH, Mobil-O-Graph®, Bedienungsanleitung, Rev. November 2000 ® Mobil-O-Graph NG , Operating instructions, Rev. 1.5 05/2007, GmbH

3.6

4.3. PRODUKTBESCHREIBUNG PRODUCT DESCRIPTION

3.6 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 defibrillator rated equipment

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

Manufacturing date

CE mark

Meaning: Date of manufacture

Meaning: The device fulfils the basic requirements of the European Directives on medical products.

I.E.M. GmbH, Mobil-O-Graph®, Bedienungsanleitung, Rev. November 2000 ® Mobil-O-Graph NG , Operating instructions, Rev. 1.5 05/2007, GmbH

4. Hypertension Management Software for Windows®

4

4. Hypertension Management Software for Windows® Blood pressure is measured by the ABP monitor and the reading stored. On completion of measurements, the stored readings are transferred to your computer, and you can then evaluate them according to your requirements. A patient file is prepared, containing all important data such as: * Personal patient ID number (obligatory entry) * Name (obligatory entry) * Address, telephone number * Personal data (age, sex etc.) * Medication The software program offers you various options for analysis. You can choose to display the results on your screen or print them out directly as: * Display of all individual measurements * Statistical analysis with mean blood pressure values for the whole day, and for the daytime and night-time periods and the first hour after waking, plus hourly mean values * Extreme values (maximum and minimum values) * Percentage incidence of values above a predetermined limit * Standard deviation (variability) * Calculation of day/night reduction * Graphs such as: * Curve of measurements * Bar chart of measurements * Histogram of blood pressure distribution * Curve comparison for optimising treatment * Envelope curve of hourly mean values * Curve of blood pressure changes * Correlation * Pie chart of percentage of values exceeding limits This equipment allows rapid and simple visualisation of the course and fluctuations in blood pressure over the day and night. Medication can be adjusted to take the best possible account of these changes. Using the same program, readings from the “Klock®” - the blood pressure monitor wristwatch - and the Stabil-O-Graph® - the upper arm blood pressure monitor - can also be entered and the data managed. An infrared eye is required for data transfer. For further information, please contact your specialist dealer or I.E.M. GmbH direct.

4.1 Installation 4.1.1 Installation in Windows 95 / 98 / NT / 2000 / ME / XP Switch on your PC. Insert the CD into the CD-ROM drive. If installation does not start automatically, choose “Start”, enter <cd>:SETUP and click ENTER (<cd> represents the CD-ROM drive). The following window will appear:

Figure 4.1.1 USB cable: If you are using the USB cable for data transfer, you must first install the corresponding driver. At this time, the USB cable must not yet be plugged into your computer! Select the “USB cable driver” button and follow the instructions until driver installation is complete. Hypertension Management Software: To install the Hypertension Management Software, select the “HMS Installation” button and follow the instructions until installation is complete.

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH

4. Hypertension Management Software for Windows®

4.2.2 Network installation: Contact your practice IT manager

4.1.2 Update installation Should an older version of HMS for Windows® already be installed on your PC, proceed exactly as for the initial installation (see 4.1.1). All existing patient data and measurements will be retained. To use the Mobil-O-Graph NG® you need Version 7.0 or later.

4.2 Program structure

The program is designed to allow you to move step by step through it from the first screen displayed. You can either use the mouse or move by using the function keys F1–F12. You can also use the program with the “Alt” key + the underlined letters and/ or the cursor keys (arrow keys). The description given below in this manual is for mouse operation only, as this is the most convenient method, but you can, of course operate without a mouse, as is clear from the instructions.

4.2.1 Menu bar The menu bar displays all operating or selection criteria for the screen in question.

Figure 4.2.1: Menu bar (excerpt) 4.2.2 Toolbar Using the toolbar (see Figure 9.1: Menu bar (excerpt)) you can simplify and speed up your work, as the main functions (buttons shown on the active areas) are directly available by clicking the appropriate symbol. If you do not wish to use the toolbar, you can remove it from the screen, by going to the “Settings” menu and clicking on the “Toolbar” command. Click this command again to make the toolbar visible again.

Figure 4.2.2: Toolbar

4.3 Brief instructions

1) Load existing patient or set up a new patient. Note: After setting up a new patient, selection of the available series of measurements must be discontinued, as no monitoring session has yet been recorded. 2) Connecting to the recorder (co mode). See section Preparing the monitor. 3) Send patient ID number to recorder, and check the protocol used and time. 4) Close HMS for WINDOWS and disconnect the monitor from the computer. 5) Switch recorder off and on again. When the time is displayed, the recorder is ready to be fitted to the patient as described in the section Preparing for monitoring. 6) After a 24-hour monitoring is complete, connect the recorder to the PC and download the readings from the recorder as described in the section Analysis

4.4 The first steps

Open the ABPM program via START – PROGRAM HYPERTENSION MANAGEMENT. Using the mouse, now click on the function you require on the menu bar. The submenu will then appear and you can start the function by clicking the appropriate command. The process is even quicker if there is a symbol on the toolbar for the function you require. Then simply click the appropriate symbol. The number of symbols displayed depends on the screen resolution you have set. To allow you to get to know the program, a fictitious patient has been set up as an example.

4.4.1 Example Loading:

Measurements:

You can look at the data for the sample patient, John Doe, by clicking “Patient” on the menu bar and selecting the command “Load”. Alternatively, you can click on the symbol on the left. On the screen that now appears, mark the patient John Doe, either by entering the name in the “Find name” field or directly clicking on the name “Doe” in the Table, so that the name is highlighted in colour. Then click “OK”. The window with the patient’s data will be built up. If you now click “OK” again, the “Existing measurements” window will appear. You can now select a series of readings by marking it and clicking “OK”. You then return to the basic screen, although you will notice that you now have more choices of symbols than before and you can also open a larger number of commands on the “Measurements” menu.

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4.4.4

Now simply run through the various evaluations by clicking on the symbols..

This will give you an initial overview of the variety of analysis and display options offered by the program. You will always return to the basic screen when you click Close. 4.4.2 Help

You can call up various Help topics from all parts of the program. It is also possible, for example, to call up the Direct help screen, which gives explanations on the topic you are currently processing. In addition, however, you can also have displayed detailed help screens on particular questions or topics. To make use of this option, call up the menu. Under the menu commands “Contents”, “Search” and “Use help”, you have a wide variety of question options, topic overviews and explanations of functions.

4.4.3 Window Using the “Window” menu you can see how many windows you have opened at one time. Click the appropriate window to move backwards or forwards between the various analyses. 4.4.4 Closing the program To leave the program click “Close” either using the button or the command in the “Patients” menu.

4.5 Patient data 4.5.1 Entering new patients in the database Using the button or the “New” command in the “Patients” menu, call up the input screen for entering new patients .

Figure 4.5.1: Patient data Move through the record sheet during input using the tabulator key. For later allocation of measurements, however, the only other important feature apart from the ID number is the name (both inputs are sort and search criteria). All other information is voluntary. Using the “Diagnosis” field, you can enter your diagnosis for the patient in a text field. The “Extended” switch opens a box for entering more detailed patient information, such as medication, telephone number, email address or the one-off blood pressure result taken manually. Once entered, the values are available at all times and can also be changed.

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4.5.3 To save the new patient, click OK

If you do not wish to save the data entered, click Close. You will again be asked whether the data should be saved. If you click “No”, the data will not be saved and the window will be closed. 4.5.2 Loading stored patient data From this list, select a patient, to see their findings to date, to program the recorder for this patient or to allocate a new series of results to the patient. From this list, select a patient, to see their findings to date, to program the recorder for this patient or to allocate a new series of results to the patient.

Figure 4.5.2: List of patients You can load the patient either by double-clicking his or her name in the list, or by marking the name with a single click and then opening using the “OK” button. Search: Enter the surname of the patient in the “Name search” field to find him or her quickly. Alternatively, you can enter the patient’s ID number in the “Pat. no. search” field. List:

If you click on the “Print list” field, the whole list of patients will be printed, sorted either alphabetically by name or by patient ID numbers, depending on the sort criterion selected.

4.5.4 Exporting readings (ANSI file) It is possible to store the reading from long term monitoring, which have been loaded from the recorder and then evaluated, as a report of readings, so that they are available to your practice system. Set up:

If, after selecting a series of measurements for a patient in the “Measurements” menu, you click the command “Save values in ANSI format“, the program automatically converts the data into an ANSI file. You can then access these data from your practice system.

Export file:

If you wish to change the specified name of the export file, you can do so via the “Settings” menu with the command “ANSI export file”. In this dialogue box you can enter the required name and directory of the export file.

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4.5.4

4.6 Mobil-O-Graph NG® blood pressure monitor” 4.6.1Preparing the monitor Connection via cable:

Connection via infrared:

Make sure that your PC is switched off. Connect the interface cable supplied to the selected interface of your PC. The other end of the cable is now connected to the recorder, which must be switched off. The plug is inserted in the port on the recorder until it engages. Please do not force it! Switch on the monitor. The letters “co” should be visible on the display. If your PC does not have a free serial port, you can also use a USB port with the USB combi cables. Switch on the Mobil-O-Graph NG®. Open the interface menu by pressing and holding the Start key, and then pressing the Day/Night key. You can now choose between the flashing messages “co”, “bt” and “PAIr” with the Start key. Select “co” and confirm this with the Event key. The letters “co” now longer flash and the inter face is active. Now point the “IR-Med” IR interface, which is connected to your PC, towards the IR interface of the Mobil-O-Graph NG® at a distance of 10–15 cm. Two IR interfaces are available from I.E.M. (see also Figure 4.7.1): - IR-Med with serial interface to PC - IR-Med with USB interface to PC Note:

- The devices are not compatible with existing built-in infrared interfaces, for example in laptops. - If there is no activity, the “co” mode will stop after 10 minutes.

Set-up:

You must first decide on a free serial port on your PC. In the “Settings” menu you can use the “Interface for monitor” command to open a dialogue window, in which you can select the serial port you wish to use to connect the Blood pressure monitor to your PC. (Note: COM1 is general ly already being used for the mouse.) Click “OK” to save your setting.

Preparation:

Using the “Monitor” menu, the “Prepare” command will take you into the window for programming the recorder for the next monitoring session. You can also reach this window via the button shown on the left. You now select the measurement protocol to be used for the monitoring session. The parameters you will enter include the time intervals (throughout the day) at which measurements are to be taken (intervals always start on the hour), and whether the values measured are to be shown on the monitor display after a measurement or not. These changes can be undertaken in protocol 1 and protocol 2.

Important:

You must in any case enter all the intervals, even if you wish to select only one interval for the whole of the monitoring session. In this case please set the same characteristics of measurement frequency and acoustic signals for all intervals; only the start times must be different.

Acoustic signal:

Using the “Buzzer” option, choose whether or not an acoustic signal is to be emitted to warn of a measurement.

Monitor clock:

Using the “Set recorder clock” function, you also have the option of setting the time shown on the monitor to that of your computer.

Monitor test:

To ensure that the monitor is functioning correctly, you can test its functions before starting the monitoring session. Click the button

to get to Figure 4.6.1:

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4.6.2

Figure 4.6.1: Monitor test Click the individual test functions to test the equipment accordingly. Patient ID number: The patient ID number just stored in the monitor is saved by clicking the active area, so that readings can later be allocated to the patient automatically when downloaded to the PC. Switching off:

Now switch the recorder off, and disconnect the PC connector cable. Now switch the equipment on again; after the battery voltage has been displayed, the display will show the time.

Protocol:

By pressing and holding the Day/Night key while pressing the Event key, check whether the right measurement protocol has been saved (protocols1 and 2 can be changed as you wish). The protocol can also be selected directly from the PC in “Preparing the monitor”, by marking the button with an X by clicking.

Note:

It is extremely important always to check the protocol set before starting the long-term moni toring process, since no further change can be made to the protocol once the first measurement is under way.

Measurement:

Please follow the instructions in the sections Preparing for monitoring, section. 3.4/ Putting on the Monitor and starting measurements section. 3.4.6 and Instructions for the patient section.2.6.

4.6.2 Downloading from the monitor after the 24-hour monitoring session Reconnect the monitor to your PC, and the switch the monitor on. “co” is shown again on the display. If you are using the IR interface, select “co” using the keys of the Mobil-O-Graph NG® (see section 4.6.1). If you stored the patient’s ID number in the recorder during preparation of long term monitoring, you now only need to select the “Download” command from the basic screen in the “Monitor” menu or click the button, to have the measurements allocated automatically to the patient. However, if you have not stored the patient ID number in the recorder, you must first load the patient (see section 4.5.2), in order to use the “Download” command in the “Monitor” menu. After downloading you will be asked whether you wish to delete the data in the recorder. If the transfer was completed without an error message, click “Yes” to allow you to prepare the recorder for the next patient. If you do not delete the data at this point, you will be reminded to do so again later when you are setting up the new patient.

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4.7.2

4.7 “Stabil-O-Graph®” (optional) 4.7.1 Infrared data transmission using the “Stabil-O-Graph®” The Stabil-O-Graph® provides a wireless method of exchanging data with a computer (PC) via an infrared interface. Data exchange is possible as soon as the infrared connection between the device and the computer has been established. I.E.M. provides two IR interfaces: - IR-Med with serial interface to PC - IR-Med with USB interface to PC Note:

The devices are not compatible with existing built-in infrared interfaces, for example in laptops. The IR interface provided by I.E.M. can also be used for your Mobil-O-Graph NG®.

System requirements * Computer with a free serial 9-pole interface, or computer with a free USB interface. * Successfully installed HMS software * Separate infrared interface (see Fig. 4.7.1)

Figure 4.7.1: Infrared interface with 9-pole serial connection Installation instructions for the serial infrared interface 1. Take care to ensure that your PC is switched off. Connect the infrared interface to a free serial port at the rear of the computer and tighten the screws.

Figure 4.7.2: Connecting infrared interface to the computer 2. Switch on the computer and start the software. 3. Set the serial interface in the software, by choosing “Interface for monitor” in the “Settings” menu. Installations instructions for the USB infrared interface 1. First, install the USB driver found on the CD of HMS software before connecting the IR interface to the PC for the first time. 2. Set the IR interface in the software by choosing “Interface for monitor” in the “Settings” menu. 4.7.2 Preparing for monitoring • Ensure that the batteries in the unit have enough capacity, i.e. date and time are shown, but the battery symbol is invisible. • Switch the unit into transmission mode. First press and hold the START key, then also press the MENU key. “co” will appear and the unit is ready to exchange data. • Place the unit and the infrared interface on a smooth surface, about 2–10 cm apart. Please point the infra red interface towards the side window of the unit. • Take care to ensure that the unit remains in the same position during the whole transmission.

Mobil-O-Graph NG®, Operating instructions, Rev. 1.5 05/2007, GmbH