IEM Mobil O Graph Manual
IEM Mobil O Graph Manual
Analysis unit:
Hypertension Management Software
Client-Server Version 5.1
(HMS CS 5.1)
Dealer:
EN
Copyright© Mobil-O-Graph® Revision 5.1 10/2015 I.E.M. GmbH All rights reserved.
The contents may not be copied or published without written permission from I.E.M.
GmbH.
Manufacturer:
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Mobil-O-Graph®, operating instructions, Rev. 5.1 10/2015, GmbH
Contents
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Mobil-O-Graph®, operating instructions, Rev. 5.1 10/2015, GmbH
Contents
6. Troubleshooting.................................................................................................77
6.1 Principal sources of error ............................................................................ 77
6.2 Battery voltage curve .................................................................................. 77
6.3 Transmission errors .....................................................................................77
6.4 Check list ..................................................................................................... 77
6.5 Error tables .................................................................................................. 77
6.5.1 Troubleshooting, Mobil-O-Graph® ............................................................................. 77
6.5.2 Communication errors, Stabil-O-Graph® ................................................................... 80
6.5.3 Communication errors, Mobil-O-Graph® Bluetooth interface ................................... 81
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Mobil-O-Graph®, operating instructions, Rev. 5.1 10/2015, GmbH
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 suc-
cessful 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 integrat-
ed 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.
1.4 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
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Mobil-O-Graph®, operating instructions, Rev. 5.1 10/2015, GmbH
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.
2.3 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.
Warnings:
■ The shoulder strap or cuff tube can become entangled around the patient’s neck and lead to stran-
gulation.
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2. Operating instructions 2.6
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 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 mal-
function.
■ 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 tem-
perature 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 fibril-
lation, 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.
■ 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 meas-
urements.
You can find a form to copy and give to the patient in the Appendix!
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Mobil-O-Graph®, operating instructions, Rev. 5.1 10/2015, GmbH
3. Product description
3.1 Introduction
The Mobil-O-Graph® system consists of two principal components:
■ the Mobil-O-Graph® NG or Mobil-O-Graph® PWA with different cuffs and further accessories.
■ analysis software for the doctor to analyse the measurements.
Measurements from ABP monitor can be interpreted using the analysis unit HMS Client-Server. Using this soft-
ware, saved measurements can be downloaded to a PC, presented on the screen in various forms, as dia-
grams, lists and statistics, and printed out.
The Mobil-O-Graph® can then be prepared immediately for the next patient. With a little practice, this proce-
dure 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 pres-
sure 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.
3.3.1 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 3.3.2
DAY/NIGHT The DAY/NIGHT key allows waking and sleeping phases to be differentiated when record-
ing, which is important from the point of view of statistical evaluation and graphic presenta-
tion. For precise details of the effects on the printout, please see the relevant sections on
analysis.
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 individu-
al 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 inter-
val 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 plausibil-
ity, to ensure that the subsequent automatic measurements are correct, and that
the cuff fits properly. If the measurement is incorrect, the instructions in the sec-
tions Preparing for monitoring and Troubleshooting should be followed.
When the Start key is pressed, the number of measurements recorded so far is dis-
played and manual measurement begins. This differs from automatic measurement
according to the monitoring protocol, in that the cuff is inflated in stages. This deter-
mines the cuff pressure required to allow the systolic blood pressure to be meas-
ured. This maximum inflation pressure is stored and is then approached immedi-
ately 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:
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.
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3.3.6 3. Product description
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:
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.
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3. Product description 3.4.6
You can set the protocols manually by holding down the Day/Night and then pressing the Event key. Use the
Start/Stop key to change the protocol, and confirm with the Event key.
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3.4.6 3. Product description
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 work-
ing 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.
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3. Product description 3.5
3.6 Symbols
Battery symbol
Meaning: The symbol shows the type of voltage.
Defibrillator rating
Meaning: BF applied part, defibrillator protected
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, Self-
measurements). 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.
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 meas-
urement 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
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4. Hypertension Management Software Client-Server 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.
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4.2.2 4. Hypertension Management Software Client-Server
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Mobil-O-Graph®, operating instructions, Rev. 5.1 10/2015, GmbH
4. Hypertension Management Software Client-Server 4.2.4
4) Enter a filename and location to save the data you are backing up.
5) Click Save.
6) Your data is backed-up.
Restore data
To restore your data, proceed as follows:
1) Launch your Hypertension Management Software.
2) In the menu bar, click on Data -> Data back-up and Restore data.
3) The Back up data window appears.
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4.3 4. Hypertension Management Software Client-Server
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4. Hypertension Management Software Client-Server 4.4.1
■ Menu Patient
■ Menu Settings
Note: for detailed information see 4.12, Setting standard values for HMS CS
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4.4.2 4. Hypertension Management Software Client-Server
■ Menu ?
4.4.2 Toolbar
At the top of the control window, below the Menu bar is the Toolbar. It contains buttons (symbols) for calling up
important functions quickly. 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).
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
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.
Basic knowledge and experience of the operating systems Windows®, Macintosh® or Linux® are required
for using HMS CS.
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4. Hypertension Management Software Client-Server 4.5.1
Top right in the window you will see the patient’s name and date of birth.
The Patient information tab contains several fields: address, patient data, emergency contacts, medical
history and medication.
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4.5.3 4. Hypertension Management Software Client-Server
The highlighted values are measurements that lie outside the defined limits (see 4.12, Setting standard val-
ues for HMS CS).
► To display further analyses, click the header of the analysis you wish to see.
Tip: If your mouse pointer hovers over a tab header, a brief explanatory text will appear (Tooltip).
You can find further information about analyses under 4.11, Analysing measurements.
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4. Hypertension Management Software Client-Server 4.6.2
Patient ID and Surname are mandatory fields (both details are criteria for searching and sorting), all the
other details are optional.
Tip: Use the tab key to jump from one field to the next.
Confirm with .
The Patient information tab contains several fields: address, patient data, emergency contacts, medical his-
tory and medication.
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4.6.3 4. Hypertension Management Software Client-Server
► click .
The window New patient appears (for how to proceed further see 4.6.1, Entering new patient).
► Click .
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4. Hypertension Management Software Client-Server 4.6.6
► Confirm with .
The current patient is deleted, including all measurements.
► Type the measurements, date and time in the window Manual BP measurement.
► Click .
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4.6.9 4. Hypertension Management Software Client-Server
► In the window Manual weight measurement type in weight, date and time.
► Click .
4.6.9 Audit trail
To display the record of all patient data changes, click Audit trail in the File bar.
Step Mobil-O-Graph® PC
1) ► Switch off the Mobil-O-Graph®
2) Establishing a connection between Mobil-O-Graph® and PC
a) via serial interface (COM1,2...) with cable or combi cable
► Switch off the PC
► Connect the cable to the serial interface
(COM1,2...)
► Switch on the PC.
b) via USB interface
► Connect the cable to a USB port.
3) ► Insert the plug into the data port on the left-
hand side of the housing until it engages.
Note: The red dot on the plug must be aligned
with the red dot on the data port.
Caution: Do not force it!
4) ► Switch on the Mobil-O-GraphNG®
co appears on the display..
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4. Hypertension Management Software Client-Server 4.7.1
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras).
In this case, select a patient (see 4.6.2,
Selecting existing patient)
► In the Menu bar click Settings and then
Interfaces.
► In the window Interfaces click the Serial/IR/
USB tab.
► Set COM1,2... as the interface (see 4.12.4,
Interfaces)
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
► Display the patient (see 4.6.1, Entering new
patient and 4.6.2, Selecting existing patient)
► Click .
► Click .
► Click .
► Click .
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4.7.1 4. Hypertension Management Software Client-Server
Step Mobil-O-Graph® PC
1) ► Put the monitor on the patient (put on the cuff
and connect it to the recorder).
► Switch on the Mobil-O-Graph®.
On the display appears the time set.
Step Mobil-O-Graph® PC
1) ► Switch off the Mobil-O-Graph®
► Take the monitor off the patient (take off the
cuff and disconnect the recorder).
2) Establish a connection between Mobil-O-Graph® and PC
a) via serial interface (COM1,2...) with cable or combi cable
If the cable is no longer connected to the PC:
► Switch off the PC
► Connect the cable to the serial interface
(COM1,2...)
► Switch on the PC.
b) via USB interface
► Connect the cable to a USB port.
3) ► Insert the plug into the data port on the left-
hand side of the housing until it engages.
Note: The red dot on the plug must be aligned
with the red dot on the data port.
► Switch on the Mobil-O-Graph®
co appears on the display..
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4. Hypertension Management Software Client-Server 4.7.2
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras).
In this case, select a patient (see 4.6.2,
Selecting existing patient)
► Click .
The question appears: Delete patient ID and
measurements from the recorder?
► Click .
After data transmission the window
Measurement series appears.
► If necessary, change the times for the daytime
and night intervals.
► Click .
The transmitted measurements are displayed
as a Table of measurements.
2) ► Switch off the Mobil-O-Graph®
► Disconnect cable (pull the plug from the data
port).
For further analysis of the measurement series see 4.11, Analysing measurements.
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4.7.2 4. Hypertension Management Software Client-Server
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras).
In this case, select a patient (see 4.6.2,
Selecting existing patient)
► In the menu bar, click settings and then
Interfaces.
► In the window Interfaces click the Bluetooth
tab.
► Click .
The message appears: Switch on the Mobil-O-
Graph® and change to PAIr mode.
2) ► Switch on the Mobil-O-Graph®
Change to PAIr mode:
► Press .
PAIr stops flashing and the buzzer sounds.
3)
► Click .
After a moment, the serial number appears
in the window, for example C00607.
► Click the serial number.
► Click .
The message appears: Pairing successful.
► Click .
The window Connection with device appears.
► Click .
4) Buzzer sounds
5) The monitor appears in the window Interfaces in
the Bluetooth tab.
► Click .
6) ► Switch off the Mobil-O-Graph®
The Bluetooth interface between the Mobil-O-Graph® and the HMS-CS program is now configured. The soft-
ware will detect the presence of the Mobil-O-Graph® as soon as the recorder is placed in Bluetooth communi-
cations mode, denoted by “bt” on the recorder display.
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4. Hypertension Management Software Client-Server 4.7.2
Step Mobil-O-Graph® PC
1) ► Switch on the Mobil-O-Graph®
2) ► Start HMS CS.
► Press .
bt stops flashing and the buzzer sounds.
4) The window Action of device appears.
5) Buzzer sounds twice.
6)
► Click .
Caution: If battery voltage is insufficient for
24-hour monitoring, a message will appear.
Please note this information!
The window Prepare monitor appears.
► Set the protocol for 24-hour monitoring (see
4.8.1, Setting the measurement protocol).
► Click .
► Click .
► Click .
► Click .
7) Buzzer sounds.
First, bt end and then the time appears on the
display.
8)
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4.7.2 4. Hypertension Management Software Client-Server
Step Mobil-O-Graph® PC
1) ► Put the monitor on the patient (put on the cuff
and connect it to the recorder).
Read out measurements from 24-hour monitoring from Mobil-O-Graph® via Bluetooth
Starting situation:
■ Mobil-O-Graph® is switched on,
■ PC is switched on,
■ Mobil-O-Graph® interface recognises HMS CS.
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
► Press .
bt stops flashing and the buzzer sounds.
3) Buzzer sounds twice.
4)
► Click .
The question appears: Assign measurements to
patient with ID number xxx?
► Click .
After data transmission the window
Measurement series appears.
► If necessary, change the times for the daytime
and night intervals.
► Click .
The question appears: Assign measurements to
patient with ID number xxx?
► Click .
The transmitted measurements are displayed
as a Table of measurements.
4) Buzzer sounds.
First bt end, and then the time appear on the dis-
play.
► Switch off the Mobil-O-Graph®.
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4. Hypertension Management Software Client-Server 4.7.3
When using the Mobil-O-Graph® monitor with the IR-Med infrared interface, follow these steps:
■ Connect the monitor to the PC,
■ Configure the monitor in HMS CS
■ Set the monitor for the patient using HMS CS,
■ Test the monitor and put it on the patient.
After 24-hour monitoring
■ Take the monitor off the patient (take off the cuff and disconnect the recorder),
■ Read out measurements from monitor and save them in HMS CS under patient information.
Step Mobil-O-Graph® PC
1) ► Switch off the Mobil-O-Graph®
2) Establish a connection between Mobil-O-Graph® and PC
a) via serial interface (COM1,2...) with cable or combi cable
► Switch off the PC
► Connect the cable to the serial interface
(COM1,2...)
► Switch on the PC.
b) via USB interface
► Connect the cable to a USB port.
3) ► Point the Infrared interface of the Mobil-O-
Graph® towards the IR-Med infrared interface
at a distance of 10-15 cm.
4) ► Switch on the Mobil-O-Graph®
Change to co mode:
► Press .
co stops flashing and the buzzer sounds.
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4.7.3 4. Hypertension Management Software Client-Server
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras).
In this case, select a patient (see 4.6.2,
Selecting existing patient)
► In the menu bar, click Settings and then
Interfaces.
► In the window Interfaces, click the Serial/IR/
USB tab.
► Set COM1,2... as the interface (see 4.12.4,
Interfaces)
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
► Display the patient (see 4.6.1, Entering new
patient and 4.6.2, Selecting existing patient)
► Click .
► Click .
► Click .
► Click .
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4. Hypertension Management Software Client-Server 4.7.3
Step Mobil-O-Graph® PC
1) ► Put the monitor on the patient (put on the cuff
and connect it to the recorder).
► Switch on the Mobil-O-Graph®.
2)
► Press for a manual measurement, to
ensure that the monitor works as it should.
► Wait for the first, manual measurement.
If everything is in order, the patient can leave.
A successful measurement is necessary to
activate the protocol!
After 24-hour monitoring session, connect PC to Mobil-O-Graph® via IR-Med infrared interface
After 24-hour monitoring session, transmit data from the monitor to HMS CS.
Starting situation:
■ Mobil-O-Graph® is on the patient’s arm and is switched on.
■ PC is connected to IR-Med infrared interface.
Step Mobil-O-Graph® PC
1) ► Switch off the Mobil-O-Graph®.
► Take the monitor off the patient (take off the
cuff and disconnect the recorder).
2) ► Point the Infrared interface of the Mobil-O-
Graph® towards the IR-Med infrared interface
at a distance of 10-15 cm.
3) ► Switch on the Mobil-O-Graph®.
Change to co mode:
► Press .
co stops flashing and the buzzer sounds.
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4.8 4. Hypertension Management Software Client-Server
Step Mobil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras). In
this case, select a patient(see 4.6.2, Selecting
existing patient)
► Click .
After data transmission, the window
Measurement series appears
► If necessary, change the times for the daytime
and night intervals.
► Click .
The question appears: Delete patient ID and
measurements from the recorder?
► Click .
The transmitted measurements are displayed
as a Table of measurements.
2) ► Switch off the Mobil-O-Graph®.
For further analysis of the measurement series see 4.11, Analysing measurements.
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4. Hypertension Management Software Client-Server 4.8.1
■ Stabil-O-Graph® (optional)
Selecting a protocol
► In the pop-up field Protocol click the protocol you require.
► In Protocol 1 or 2, set the timeframe (beginning of time interval) under daytime interval and night interval,
■ timeframe (beginning of time interval),
■ the number of measurements during this interval,
■ whether the measurement will be shown on the monitor (Display measurements),
■ and whether an acoustic signal (buzzer) will sound as the measurement starts.
Transmit protocol
► Click .
► Confirm with
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4.8.2 4. Hypertension Management Software Client-Server
► Click .
► Confirm with
The monitor shows the imported time.
► Click .
► Confirm with
► Click .
The window Device testing appears. Its content depends on the type of monitor.
■ Mobil-O-Graph®
■ Stabil-O-Graph® (optional)
► Confirm with
Complete testing
► Click .
► Click .
► Confirm with
► Click .
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4. Hypertension Management Software Client-Server 4.8.7
The time and type of reminder are imported from the monitor and displayed.
► Click .
► Confirm with
► Click .
The window Prepare monitor disappears.
► Disconnect the physical connection between monitor and PC.
► Put the monitor on the patient (put on the cuff and connect it to the recorder).
► Switch on the monitor.
Ensure that the monitor works as it should.
► Put the monitor on the patient (put on the cuff and connect it to the recorder).
Ensure that the monitor works as it should.
► Press any key.
The time and date are displayed.
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4.9 4. Hypertension Management Software Client-Server
If yes If not
The question appears: Assign measurements to ► Select the required patient (see 4.6.2, Selecting
patient with ID number xxx? existing patient).
► Click .
The measurements are imported into HMS CS and saved under that patient.
The question appears: Delete Patient ID and measurements from the recorder?
Note: It is normally sensible to delete these details from the monitor. When preparing the monitor for a “new”
patient, HMS CS indicates whether “old” measurements are still in the monitor.
If yes If not
► Click . ► Click .
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4. Hypertension Management Software Client-Server 4.9.5
► Click .
The measurements transmitted are displayed as a table of measurements (see 4.11.1, Table of measurements).
► Click .
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4.10 4. Hypertension Management Software Client-Server
When using the Stabil-O-Graph NG® monitor with the IR-Med infrared interface, follow these steps:
■ Connect the monitor to the PC,
■ Configure the monitor in HMS CS
■ Set the monitor for the patient using HMS CS,
■ Test the monitor and put it on the patient.
After monitoring
■ Take the monitor off the patient and connect it to the PC,
■ Read out measurements from monitor and save them in HMS CS under patient information.
Connect PC to Stabil-O-Graph®
Step Stabil-O-Graph® PC
1) ► Switch off the PC
2) Establish a connection between Stabil-O-Graph® and PC
a) via serial interface (COM1,2...) with cable or combi cable
► Connect the cable to the serial interface
(COM1,2...).
b) via USB interface
► Connect the cable to a USB port.
3) ► Point the Infrared interface of the Mobil-O-
Graph® towards the IR-Med infrared interface
at a distance of 10-15 cm.
4) Change to co mode:
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4
Step Stabil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras).
In this case, select a patient (see 4.6.2,
Selecting existing patient)
► In the menu bar, click Settings and then
Interfaces.
► In the window Interfaces, click the Serial/IR/
USB tab.
► Set COM1,2... as the interface (see 4.12.4,
Interfaces)
Step Stabil-O-Graph® PC
1) ► Start HMS CS.
► Display the patient (see 4.6.1, Entering new
patient and 4.6.2, Selecting existing patient)
► Click .
► Click .
► Click .
► Click .
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4.10 4. Hypertension Management Software Client-Server
Start measurement
Starting situation:
■ The monitor should be disconnected from the PC.
Step Stabil-O-Graph® PC
1) ► Put the monitor on the patient (put on the cuff
and connect it to the recorder).
2) ► Press any key.
The time and date are displayed.
At the patient’s next visit, connect PC to the Stabil-O-Graph® via IR-Med infrared interface
You can transmit the data from the monitor to HMS CS.
Starting situation:
■ Stabil-O-Graph® is switched on.
■ PC is connected to IR-Med infrared interface.
Step Stabil-O-Graph® PC
1) ► Switch on the PC
2) ► Point the Infrared interface of the Mobil-O-
Graph® towards the IR-Med infrared interface
at a distance of 10-15 cm.
3) Change to co mode:
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4
Step Stabil-O-Graph® PC
1) ► Start HMS CS.
If the program is set up for this, the window
Patient list will appear (see 4.12.7, Extras).
In this case, select a patient (see 4.6.2,
Selecting existing patient)
► Click .
After data transmission, the window
Measurement series appears.
► If necessary, change the times for the daytime
and night intervals.
► Click .
The question appears: Delete patient ID and
measurements from the recorder?
► Click .
The exported measurements transmitted are
displayed as a table of measurements.
For further analysis of the measurement series see 4.11, Analysing measurements.
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4. Hypertension Management Software Client-Server 4.11
Tip: If your mouse pointer hovers over a tab, a brief explanatory text will appear (Tooltip).
► Display the patient you want to see (see 4.6.2, Selecting existing patient).
► In the control window, click the Measurements tab.
The Measurements tab contains, on the left, a list of the monitoring sessions already performed.
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4.11.1 4. Hypertension Management Software Client-Server
Tip: If your mouse pointer hovers over the table header, a brief explanatory text will appear (e.g. 24h BP
monitor, automatic measurement).
Commenting on a measurement
► Click the column Commentary in the required row.
► Type in your comment.
► Press the return key.
Excluding a measurement
If one measurement is a complete outlier and would therefore falsify a representative 24-hour analysis, you
can exclude it:
► Click the column No. in the required row.
The number of the measurement disappears and that value is now excluded from statistical analyses from
now on.
Note: To include the measurement again, click the number again.
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4. Hypertension Management Software Client-Server 4.11.2
The left-hand y-axis with the units mmHg applies to systolic, diastolic and mean values (BP values).
The right-hand y-axis with the units 1/min applies to heart rate.
The x-axis applies to time. The four daily intervals are highlighted. Day counts all three daytime intervals togeth-
er. “M” signifies manual measurements
You can see the upper BP limits (systolic, diastolic) as horizontal set-point curves.
Note: You can set these values in the Patient information tab in the BP limits field.
4.11.3 Profile
In this profile view the following values of the test series will be displayed graphically as a function of time in a
bar diagram:
■ systolic values
■ median Values
■ diastolic values
■ heart rate
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4.11.4 4. Hypertension Management Software Client-Server
The left-hand y-axis with the units mmHg applies to systolic, diastolic and mean values (BP values).
The right-hand y-axis with the units 1/min applies to heart rate.
The x-axis applies to time. The four daily intervals are highlighted. Day counts all three daytime intervals togeth-
er. “M” signifies manual measurements.
You can see the upper BP limits (systolic, diastolic) as horizontal set-point curves.
Note: You can set these values in the Patient information tab in the BP limits field.
4.11.4 Correlation
This diagram shows the correlation of diastolic to systolic blood pressure. Each dot corresponds to one meas-
urement.
The y-axis applies to diastolic values. the x-axis applies to systolic values.
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You can see the BP limits as horizontal (systolic) and vertical (diastolic) set-point curves.
Note: You can set BP limits in the Patient information tab in the BP limits field.
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4.11.7 4. Hypertension Management Software Client-Server
4.11.7 Report
The report contains important statistical statements on systolic and diastolic blood pressure. The values are
shown for day and night, respectively.
Directly below Day and Night are average values and the scatter (empirical standard deviation) of the meas-
urements.
Below Systolic and Diastolic you will see the frequency distribution of the measurements. The frequency distri-
bution shows how many measurements out of all the valid measurements lie above a particular value. The BP
limit set for this patient is used as a starting value.
Note: You can set the BP limits on the Patient information tab in the BP limits field.
The result report can also be displayed in tabular form. Click on analysis in the settings menu and
check the tabular display box
Below Day/Night lowering you can see the percentage lowering of the BP mean values (= average
values) between day and night.
Printing report
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The left-hand y-axis with the units mmHg applies to systolic, diastolic and mean values (BP values).
The right-hand y-axis with the units mmHg/h applies to blood pressure change.
The x-axis applies to time. The intervals for morning rise in blood pressure are highlighted.
The lower, flattened curve shows the course of blood pressure. It transforms blood pressure data in the frequen-
cy range of mean arterial pressure through Fourier analysis. The outliers are neglected, giving the curve shown
after inverse Fourier transformation. It shows the positive changes in blood pressure (mmHg per hour) for times
of rise in BP, and the negative change for times of BP lowering. The red, vertical lines mark the beginning and
end (=duration) of the early-morning rise and the time and magnitude of the maximum rise. The upper BP lim-
its (systolic, diastolic) are shown as horizontal set-point curves.
Note: You can set these values in the Patient information tab in the BP limits field.
4.11.10 Printing
The Print function enables you to print the analyses you require.
► Click .
The window Print appears.
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4. Hypertension Management Software Client-Server 4.11.11
4.11.12 24h-PWA
In this analysis, the PWA history is displayed over a 24h-period at preset protocol 11. In addition to blood pres-
sure and pulse, the following parameters are displayed as a time series:
■ Central blood pressure
■ Alx@75 [90%CI]
■ Cardiac Output [CO]
■ Total vascular resistance
► Click on the 24h-PWA tab to display the history of the values named above.
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4.11.13 4. Hypertension Management Software Client-Server
The pop-up window displays the PWA just like a PWA conducted at the doctor’s practice.
To display the bar chart (PWA), click on the bar chart (PWA) tab .
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4. Hypertension Management Software Client-Server 4.11.14
To access the patient report (day average), click on the Patient report (Day Average) tab .
The Patient report (Day Average) tab is divided into four areas:
Peripheral blood pressure:
The peripheral blood pressure area displays the peripheral systolic and peripheral diastolic blood
pressure measured.
Central blood pressure:
The central blood pressure area displays the central systolic blood pressure calculated.
Arterial stiffness:
The arterial stiffness area displays the PWV (pulse wave velocity) measured for large vessels and the
augmentation index at a heart rate of 75 1/min (AIx@75) in the case of small vessels.
Vascular age:
The vascular age area shows the vascular age of the patient determined from the haemodynamic
information. The vascular age display can be set in the Hypertension Management Software settings.
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4. Hypertension Management Software Client-Server 4
The vascular age display can be changed in the Hypertension Management Software settings. Here, you can
set the standard procedures for:
• Absolute or relative vascular age
• Patient report display with or without smiley
Through combinations of these settings, you have the following options for displaying the vascular age in the
patient report:
Option 1: Depiction with smiley, vascular age: relative
Option 2: Depiction with smiley, vascular age: absolute
Option 3: Depiction without smiley, vascular age: relative
Option 4: Depiction without smiley, vascular age: absolute
4.12 e-health
The HMS CS supports the e-health service data base (telemedicine) provided by I.E.M. GmbH. Using this ser-
vice you can setup your own virtual patient clinic. Vital values measured by the patient himself are transferred
via mobile radio to a server and can be synchronized with the HMS CS at any time.
Using the client-server solution you can:
■ Create patients for e-health on the e-health server.
■ Synchronize the data of selected patients with the e-health server.
■ Request telemetrically surveyed measured values
■ Save measured practice values on the server and enable access to them for your colleagues
► Check the active box and thereby activate the e-health service.
► Enter the user name and password, which you received from I.E.M. GmbH or your retailer.
► Click on export settings.
► The export settings window appears.
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4.12.2 4. Hypertension Management Software Client-Server
In the export settings window you can specify which data will be transferred to the e-health server and if the-
se will be anonymized.
If the anonymize box is checked, then only the patient ID is used
► Click on save.
The window disappears
► Click on
► The patient list window appears.
► Check the patients, which you want to import from the e-health server to your HMS CS.
► Click on import and the patients highlighted in blue will be imported into your HMS CS; including existing test
series.
► Click on
► The patient list window appears.
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4. Hypertension Management Software Client-Server 4.13
► Click on yes
Already opened patients can also be exported using the symbol and synchronized using the
symbol.
After the import or export of patients, the patients authorized for e-health are marked with a small in the
patient list and thereby authorized for synchronization with the e-health server.
If you open such a patient, all new telemetric measurements will be automatically polled from the e-health
server.
If you want to reverse the clearance of a patient on the e-health server, click .
► To ensure that the device functions as desired, push for the start of a manual measurement. A successful
measurement is a condition for the activation of the protocol!
► Wait for the first automatic measurement.
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4.13.2 4. Hypertension Management Software Client-Server
► After the first measurement the symbol appears in the symbol list. Click on this symbol.
► The practice monitoring window appears
► Click on assign
► The selection window appears
► Here you can assign the test series to the currently opened patient or to a patient from the patient list.
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4.14.2
► If you use Bluetooth, select in the appearing window to start the PWA measurement
window.
► If you use infrared, start the PWA measurement window with the icon in the menu bar.
► The following PWA measurement window appears:
► When all measurement steps of the PWA ran successfully please click on .
► If you use Bluetooth, select in the appearing window to start the Triple-PWA
measurement window.
► Click on OK to start the measurement.
After taking a Triple PWA measurement, a statistics window appears listing the three PWA measures taken so that
you can compare them. The individual measurements are displayed in different colours.
Click Print to print the statistics.
After the statistics window has been confirmed with OK, the window itself cannot be retrieved. The individual PWA
measurements then appear consecutively in the list of measurements already taken.
To take a Triple PWA measurement, you need three PWA licenses.
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4.14.5 4. Hypertension Management Software Client-Server
Preparing the Mobil-O-Graph ® with integrated 24h-PWA with protocol 11 starts a regular blood pressure
measurement at the preset intervals. After measuring blood pressure, a PWA is carried out as well, by re-infla-
ting the device and recording the pulse at the diastolic pressure.
The 24h-PWA measurement identifies patients suspected of having LVH (left ventricular hypertrophy) and cor-
relates with the actual physiological aortic systolic blood pressure. Initial scientific evidence shows that predic-
tions regarding mortality are significantly better suited if the MAP-C2-calibration is used.
Out of 10 measured pulse waves, one filtered, average pulse wave is determined and the central aortal pulse
wave is calculated with it.
The augmentation index (AIx) is always cited in the literature in dependence of sex, age and heart rate. For
this reason a standardized display in accordance with these conditions is often used. First the augmentati-
on index is standardized using an empiric determined regression [1] to 75 heart beats. This parameter is then
described as Alx@75. If you analyse a representative cross-section of the population, as for example descri-
bed in [2], you shall receive an age-dependent estimate for the Alx@75 plus the respective confidence inter-
val. These relevant analyses have also shown that there is a significant difference for the average Alx@75 bet-
ween men and women.
Based on research with a surveyed cross-section of the population of about 2,000 people, in the following figure
average values and 90% confidence interval were determined. As with the already discussed analysis, an incre-
ase of the Alx until the 55th year can also be identified in the self-surveyed measurements. Afterwards, a plateau
building up for both sexes follows. The level difference of the Alx between the sexes is about 8 to 10%. If the
measured values exceed the sex- and age-specific interval, further examinations according to the European exa-
mination guidelines for hypertension [3] are recommended in order to detect the reason for the dysfunction.
Figure 4.1: Average value and 90% confidence interval for the Alx@75
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4. Hypertension Management Software Client-Server 4.14.7
4
1) Wilkinson I.B. et al. Heart Rate Dependency of Pulse Pressure Amplification and Arterial Stiffness. American
Journal of Hypertension 2002;15:24-30.
2) Fantin F. et al. Is augmentation index a good measure of vascular stiffness in the elderly? Age and Ageing 2007;
36: 43-48.
3) The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH)
and the European Society of Cardiology (ESC). 2007 Guidelines for the management of arterial hypertension.
European Heart Journal 2007; 28: 1462-1536.
To retrieve the AIx and PWV history, click the Arterial stiffness tab .
4.15 GDT-Interface
The HMS CS offers the option to be integrated into a practice administration system via the GDT interface. After
the integration into the practice software (see 4.14.8, GDT settings) and the start of the HMS_GDT.EXE in the
program directory you will find a new symbol next to the IEM Logo in the upper right corner:
In this mode patient lists cannot be selected. The patient, who is transferred to the practice software, is active.
The same will be, if known, loaded from the data base or a new entry created.
For known patients the existing test series can be reviewed or be requested directly from the practice software
if the same is accordingly configured.
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4.15.1 4. Hypertension Management Software Client-Server
► You can enter the observation mode by clicking the symbol right next to the IEM Logo. The software is
then minimized and waits for incoming GDT files in the background. As soon as a file is found, the software starts
automatically with the patient.
4.16.1 Database
The patient data and the respective measurements are stored in a database. Here you can set details for acces-
sing the database. For further information, please contact your specialist dealer or I.E.M. GmbH directly.
► In the menu bar, click Settings and then Database.
The window Database appears.
► Click .
The window disappears.
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4
► Click .
The window disappears.
Important!
For the new language to become active, you must quit HMS CS and restart it.
► Click .
The window disappears.
Further information can be found in chapter 4.12
4.16.4 Interfaces
Here you can set the interface that connects the monitor to your PC. Possible connections:
■ Cable with serial interface (COM1,2...)
■ Combi cable with USB interface
■ Infrared (IR) with serial interface
■ Infrared (IR) with USB interface
■ Bluetooth.
► In the menu bar, click settings and then Interfaces.
The window Interfaces appears.
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► Click .
The device found is displayed in the pop-up list Interface.
If no device is found, a message to this effect appears.
To add the device to the Interfaces list,
► click .
The window disappears and the new device is shown in the Interface list.
► Click .
A window appears with the results of the connectivity test.
► Click .
The window Search for Bluetooth device appears.
After a moment, the serial number appears in the window, for example C00607.
► Click .
The message appears: Pairing successful.
► Click .
► Click .
The new device appears in the window Interfaces in the Bluetooth tab.
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4
► Click .
► Confirm with
The device disappears from the list.
Secure interface
To accept the details you have set,
► Click .
The window Interfaces disappears.
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4.16.6 4. Hypertension Management Software Client-Server
4.16.6 Analysis
Here you can select different settings for the analysis.
■ Initial: Additional start interval to the four day-time intervals
■ Static start: Start time of the graphic display
■ Tabular display: Here the analysis report can be switched to a tabular display.
■ With or without day/night button: Settings for the start times of the four day-time intervals.
► To change colour, in the appropriate pop-up field, click the required colour.
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4
► Click .
The window disappears.
4.16.8 Extras
Here you can set standard procedures for:
■ Calculation of mean (of all single measurements or the hourly mean values (HM)
■ Calculation of mean arterial pressure (measured MAP or calculated MAP)
■ which measurement analysis will be displayed after transmission of measurements from the device to HMS CS
CS (Table of measurements or graph).
■ Whether the Patient list will be shown on starting the program, or an „empty” control window appears.
■ Whether you are using Bluetooth.
► In the menu bar, click settings and then Extras.
The window Extras appears.
► Click .
The window disappears.
► Click Selection. Here you can set the directory shared between the HMS CS and your practice’s computer sys-
tem. The HMS CS and practice IT system must have the same setting for the directory. By preference, the pro-
gram directory of the HMS CS should be set.
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4
4.16.10 4. Hypertension Management Software Client-Server
► In the field Practice IT system -> HMS Client-Server enter the name of the GDT file that will be exporting pati-
ent data from your practice’s system to the HMS CS. The same name must be set in both the HMS CS and the
practice’s system.
► In the field HMS Client-Server -> Practice IT system enter the name of the GDT file that will be exporting the
HMS CS Report to your practice’s system. The same name must be set in both the HMS CS and the practice’s
system.
In the Version window, the following information will be shown regarding the Hypertension Management
Software:
• Manufacturer information
• Name and version of the software
• Versions of the program libraries
• Version and date of the last build
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5. Care and maintenance
To ensure lasting optimal functionality of your Mobil-O-Graph®, regular care and maintenance of the unit is nec-
essary.
Cleaning and disinfection
The user (doctor) decides, whether and when disinfection of the cuff sleeve is necessary
for reasons of hygiene (e.g. after each use).
For disinfecting the cuff sleeve, I.E.M. has successfully tested and recommends the fol-
lowing solutions:
1. Terralin Liquid (manufacturer: Schuelke & Mayr)
2. Isopropanol (70%)
Important: It is vital to observe the manufacturer's instructions for the use of these
products. Always leave the solution to dry completely.
Avoid disinfecting the cuff bladder and connected rubber tube. Before disinfecting, take
the bladder and the tube carefully out of the cuff sleeve. The bladder and tube may be
damaged by disinfectants. Do not place the cuff sleeve in the disinfectant solution. This
might damage it.
To achieve the full effect, wet the cuff cover with the disinfectant for at least five minutes.
When using other disinfectants not recommended by I.E.M., the user is responsible for
proving harmless application. Never use disinfectants that leave a residue on the product
or which are unsuitable for use in contact with skin.
Caution: Some patients have intolerances (e.g. allergies) to disinfectants or their
components. If you have such a patient or you are not sure, remove pos-
sible residues with careful washing. The cuff sleeve can be washed in
a washing machine at max. 30 °C using a mild washing powder (do not
spin). Do not use fabric softeners or other aids (e.g. disinfectant rins-
es, textile deodorants). These solutions may leave residues and dam-
age the material. The cuff sleeve is not suitable for drying in a tumble dryer.
It is important to ensure that the disinfectant is washed off completely before
setting the cuff in place. Attention, there must be no residual disinfectant on the
blood pressure cuff before setting the cuff in place over 24 hours.
The Velcro must always be fastened before washing.
Bladder: Wash the bladder only with lukewarm water, adding a mild cleaning solution if
necessary, and wipe off. Take care to ensure that no water enters the tube opening.
Monitor: Clean the Mobil-O-Graph® only with a damp cotton cloth. Do not use corrosive
liquids or solvents. Take care to ensure that no water enters the device.
IMPORTANT: If liquid does penetrate the unit, switch it off immediately and send it to I.E.M.
for testing.
Pouch: Please clean the pouch only with a damp cotton cloth (do not use corrosive liq-
uids or solvents).
Service plan
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5. Care and maintenance 5
Every 2 years As evidence of continuing to comply with the essential requirements of Directive
93/42/EEC, the Mobil-O-Graph® monitor must be subject to metrological checks
every two years. In some countries, this requirement may be the subject of nation-
al laws or regulations.
We offer to provide you with metrological check and complete servicing.
This service comprises:
■ Calibration
■ Software update
■ Functional testing: electronics, pump and pneumatic circuit.
Batteries Rechargeable batteries age. Batteries that are damaged, or with which 24-hour monitor-
ing is no longer possible, must be replaced immediately. The batteries will last substan-
tially longer if they drain completely before charging them.
The batteries supplied are of the nickel-metal hydride (NiMH) type. Self-discharge of
these batteries depends on the ambient temperature. It is therefore recommended to
leave the batteries in the charger until they are actually needed.
We recommend using I.E.M. batteries exclusively, as their capacity and quality has been
tested. Care should always be taken that the batteries’ capacity is above 1500 mAh.
Battery charger Follow the operating instructions included with the charger.
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6. Troubleshooting
6.1 Principal sources of error
The following may cause faulty measurements or undesired results:
■ Arm movement by the patient during the measurement
■ Switching off the device (e.g. at night)
■ Incorrect cuff size fitted
■ Slipping of the cuff in use
■ Absence of successful manual measurement in practice
■ Failure to take medication
■ Incorrect protocol set by the user
■ Batteries not fully or correctly charged, or worn out
■ Defect in the charging unit
Figure 6.2.1 Rechargeable batteries Figure 6.2.2 Batteries old or too little
OK / Batteries OK. voltage, wrong batteries
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6. Troubleshooting 6.5.1
6
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6.5.1 6. Troubleshooting
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6. Troubleshooting 6.5.2
6
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6
6.5.3 6. Troubleshooting
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7. Charging units
A common reason for reduced battery life is incorrect charging. If these batteries are used incorrectly, they lose
capacity and are no longer able to supply the Mobil-O-Graph® with power for 24 hours. Should the batteries
have lost their charge during storage, please recharge accordingly. For further information, please see the notes
in the Operating Instructions for the charging unit.
Tips:
■ Charge these batteries fully before using them for the first time.
■ Please note that these NiMH rechargeable batteries reach full charging capacity only after their 4th
charging cycle.
■ Recharge the batteries if they have been unused for some time.
■ Do not use batteries that have been stored at above 45 °C or below 0 °C.
■ To protect your batteries, avoid deep discharging.
■ Should the service life of the batteries sink significantly, replace all the batteries simultaneously. Never
use old, used batteries together with new, unused ones!
Safety instructions:
■ Never load non-rechargeable batteries. These may leak or explode and cause damage to health.
■ Do not dismantle the unit or the charger cable.
■ Cease using the unit if it has been damaged.
7.1 M2X
If you are using the M2X or a structurally identical charging unit, you must observe the following instructions:
■ Before using it for the first time, plug the power plug supplied into a mains socket and the small plug into
the jack on the charging unit.
■ Open the cover of the unit and place 1 to 4 rechargeable batteries individually into the upper level of the
charger (check their polarity!). Each shaft has a separate charging circuit, and each of these four circuits
can charge a battery.
If the red LED light does not come on, check whether the battery is placed correctly in the shaft, touching the
contacts. Should the red light still not come on, the battery can no longer be charged.
If the red light does not change to green after more than two hours of charging (for batteries up to 2000 mAh),
the battery is no longer capable of being fully charged and should be replaced.
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7. Charging units 7.2
If you leave a battery in the unit, it will be trickle charged so that the battery does not discharge. If you do not
use the unit for some time, remove the plug from the power supply.
Because of the unit's high charging current (950 mA for AA and 500 mA for AAA), it should be used only for high-
quality rechargeable batteries >1000 mAh (AA) and >500 mAh (AAA). The M2X quick charger has four charging
circuits, which enable 1, 2, 3 or 4 batteries to be charged simultaneously. Mignon (AA) micro (AAA), NiCd (nickel
cadmium) and NiMH (nickel metal hydride) batteries can be charged. The unit has overload protection.
Charging station
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8. Guarantee and repair conditions
Guarantee: I.E.M. provides a two-year guarantee on the hardware, that is, the actual ABP monitor. The
guarantee becomes invalid if the unit has been opened, incorrectly used or damaged deliber-
ately or as a result of negligence. The guarantee also becomes invalid if the equipment has
been repaired by an unauthorised person. The user may change only the NiMH batteries.
The guarantee does not cover normal wear and tear of rechargeable batteries, connector cable,
cuffs and tube. Under the terms of the guarantee, I.E.M. is liable only for faults that existed
when the customer acquired the product (and which may have come to light only later).
Furthermore, this guarantee is not applicable if the fault has been caused by failure to observe
the operating instructions, incorrect use, liquids, dampness, extreme temperature and climate
conditions or fluctuations, or by corrosion, oxidation, unauthorised interventions or attempts to
connect it, unauthorised opening or repair, attempts to repair using unauthorised parts, incor-
rect operation, incorrect installation, accidents, acts of God, spillage of food or drinks, chem-
ical effects or other external influences (faults in wearing parts such as batteries, which have
only a limited lifespan, are also excluded), unless the fault is directly due to flaws in material,
construction or manufacture.
Repair: If the unit has functional errors, or if constant measurement anomalies occur, you should con-
tact your Mobil-O-Graph® specialist dealer or I.E.M. GmbH directly for repair and despatch
instructions.
Caution: Do not open the housing. If the unit has been opened, all guarantees become null
and void.
MTK: As evidence of continuing to comply with the basic requirements and general
Directives (e.g. 93/42/EEC, Medical Device Operators Ordinance Art. 11 and Appendix
2) the Mobil-O-Graph® monitor must be subject to metrological checks every two
years. In some countries, this requirement may be the subject of national laws or reg-
ulations.
Liability clause: In all cases in which I.E.M. is obliged by contractual or legal reasons to damages or reimburse-
ment of expenses, we shall only be liable insofar as we, our executive personnel or auxiliary
staff can be charged with intent or gross negligence. Liability regardless of fault shall remain
unaffected in accordance with the Product Liability Act. Liability for culpable violation of fun-
damental contractual obligations shall also be unaffected; however, apart from cases in the
first and second sentence, liability shall be limited to the predictable damages typical for such
kind of contract.
A change in the burden of proof to the disadvantage of the buyer is not associated with the
aforementioned regulations. Liability for guarantees of condition or durability or by maliciously
concealing a defect is not affected by the aforementioned provisions.
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9. Appendix
9.1 EMC guidelines and manufacturer’s declaration
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9. Appendix 9.1
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretical-
ly with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnet-
ic site survey should be considered. If the measured field strength in the location in which the Mobil-O-Graph®
blood pressure monitor is used exceeds the applicable RF compliance level above, the Mobil-O-Graph® blood
pressure monitor should be observed to verify normal operation. If abnormal performance is observed, addition-
al measures may be necessary, such as reorienting or relocating the Mobil-O-Graph® blood pressure monitor.
The Mobil-O-Graph® blood pressure monitor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Mobil-O-Graph® blood pressure mon-
itor can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Mobil-O-Graph® blood pressure monitor as rec-
ommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter in m
Rate maximum output of 80 MHz to 800 MHz 800 MHz to 2.5 GHz 150 KHz to 80 MHz
transmitter P in W d=1.17 d=2.33
0.01 0.12 0.23 not applicable
0.1 0.37 0.74 not applicable
1 1.17 2.33 not applicable
10 3.70 7.37 not applicable
100 11.70 23.30 not applicable
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects and people.
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9.2 Form to copy
■ 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.
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Form to copy 9.3
Item Number
Cuff S (20-24 cm)
Cuff M (24-32 cm)
Cuff L (32-42 cm)
Cuff XL (38-55 cm)
Mobil-O-Graph® Universal Case
Complete cuff tube, 50 cm
Air connector for cuff tube
Battery charger
I.E.M. rechargeable battery AA 1.2 V
Batteries AA 1.5 V Pack of 4
PC combi cable serial
PC combi cable USB
Combi Handbook
Infrared component IR-med serial
Infrared component IR-med USB
Bluetooth USB dongle
HM software for Windows CD update
HMS client/server
PWA-Dongle
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