boso ABI-system 100 User manual

User instructions
boso ABI-system 100
0124

2
Contents
1 Contents of package 4
2 Minimum system requirements 4
3 Explanation of symbols and operating controls 5
4 Explanation of icons 6
5 Preliminary remarks 7
6 Important information 7
7 Ankle-Brachial Index (ABI) 8
8 Turning the device on 8
9 Installing the ABI system 100 software 8
• Installing the single user version 9
• Installing the network version 9
10 Installing the USB connection cable 10
11 Using the ABI-system 100 software 10
• Starting the program 10
• Calling up the Help function 10
• Conguration before rst use 10
• Entering doctor’s data 11
• Entering GDT les for incorporation in the practice 11
EDP system
• Entering limits for the ABI assessment 11
• Denition of output format 12
• Patient tab 13
• Measurement tab 14
• Profiles tab 15

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Contents
12 Preparing for an ABI measurement 16
• Attaching the cuff 16
• Assigning cuffs to limbs 16
13 Taking an ABI measurement 17
• Saving an ABI measurement 18
• Repeating an ABI measurement 18
14 Incorporation in practice EDP system via GDT interface 18
15 Cleaning the device and cuff 19
16 Disinfecting the apparatus 19
17 Warranty and customer service 19
18 Technical data 20
19 Instructions for disposal 20
20 Calibration checks - Testing instructions 21
• Function testing 21
• Testing of pressure circuit integrity and deviation of pressure 21
display
• Safety seal 21
21 EMC notes for your boso ABI-system 100 22
22 Your notes 24

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1 Contents of package
1 ABI-system 100
2 CA04 upper arm cuffs
2 CL04 ankle cuffs
1 ABI-system 100 software
1 USB cable
1 boso power supply unit art. no.: 410-7-154
1 Warranty certicate
1 User instructions
2 Minimum system requirements
• Pentium II or higher
• 256 MB RAM
• Graphics card
• 20 MB hard disk space
• USB 1.0-interface
• Microsoft Windows® XP, Windows® Vista™, Windows® 7

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3 Explanation of symbols and operating controls
START key
Press this key to start an ABI measurement manually. All 4 cuffs will be
inflated.
STOP key
Press this key to cancel an ABI measurement manually. All 4 cuffs will be
deflated and the display switched off.
Key for starting and cancelling a single measurement
These keys enable the user to start and cancel individual measurements
of the limbs.
Power on indicator
The green light is illuminated when power is supplied to the device.
Cuff connection
Right arm
(colour code red)
Cuff connection
Right leg
(colour code black)
Cuff connection
Left arm
(colour code yellow)
Cuff connection
Left leg
(colour code green)

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Read the user instructions
4 Explanation of icons
Protection class II device
Degree of protection against electric shock: type BF
USB 2.0 connection
The CE mark documents compliance with the Medical Devices
Directive 93/42/EEC,
Notified body: DEKRA, 0124
0124
Year of manufacture
Potential equalisation
Do not dispose of this device in the domestic waste. For further
information see page 20.
Manufacturer

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5 Preliminary remarks
Your boso ABI-system 100 is an innovation on the market of blood pressure mea-
surement technology. It provides a simple way of determining the ankle-brachial
index (ABI) and works on the oscillometric measurement principle. The pressure
variations (oscillations) caused by pulse waves and transmitted by the cuffs are
stored and evaluated by microprocessors. The great advantage of this type of
measurement is that there is no need for a microphone or amplifier which must be
positioned exactly if accurate results are to be obtained.
This system complies with the European directives on which the German Medical
Devices Act (CE mark: CE0124) is based and with European Standard EN 1060,
Part 1: “Non-invasive sphygmomanometers - General requirements” and Part 3:
“Supplementary requirements for electro-mechanical blood pressure measuring
systems”.
Calibration checks - every 2 years at the latest - can be performed either by
the manufacturer, or the trade measurement authorities, or persons who fulfil
the requirements of the legislation governing the operation of medical devices
(German Medical Devices Operator Ordinance section 6). Instructions for cali-
bration checks can be found on page 21 of these user instructions.
Medical electrical apparatuses are subject to specific precautions as regards elec-
tromagnetic compatibility and must therefore be installed and operated according
to the EMC instructions given on pages 22 and 23.
6 Important information
• The same exclusion criteria apply for oscillometric ABI measurements as for
Doppler measurements.
• Cardiac arrhythmias can interfere with the accuracy of a measurement and pro-
duce incorrect readings. Interference can also occur in wearers of pacemakers
if they have a weak pulse. The blood pressure monitor will have no effect on the
pacemaker, however.
Do not use the apparatus in patients with severe heart failure.
Do not use the apparatus unattended in unconscious, helpless or unresponsive
persons.
Do not place the cuffs over open wounds, implanted stents or lymphoedema.
Allow an interval of at least 2 minutes between 2 consecutive measurements.

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7 Ankle-Brachial Index (ABI)
To determine the ABI value, the systolic blood pressure values of the arms and
legs must be measured. Blood pressure measurement values are given in mmHg
(mm of mercury).
The ABI is calculated as a quotient of the systolic pressure of the leg measure-
ment (the mean pressure of the posterior and anterior tibial arteries) and the
higher systolic pressure of the arm measurements.
• Operating the device in the vicinity of strong electromagnetic fields (e.g. radiation
devices, mobile phones) can cause it to malfunction (see pages 22 and 23).
• The computer used for the analysis must meet the requirements of EN 60601-1.
• If the instrument is to be sold, ensure that these user instructions are enclosed.
9 Installing the ABI-system 100 software
After the “ABI-system 100” CD is inserted,
a selection window will appear to enable
the software to be installed either as a
single user version or as a network
version.
¹ Deutsches Ärzteblatt | Vol. 102 | Issue 34-35 | 29 August 2005 | Knöchel-Arm-Index | C. Diehm, H. Darius, D. Pittrow, J. Allenberg
8 Turning the device on
The mains connection socket is located at the rear of the device. Use only the
boso power supply unit (order no. 410-7-154), as it produces a rectified output of
the correct polarity. Other commercially available power supply units can cause
damage to the electronic components, which will invalidate the warranty.

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Installing the single user version
Click the [Installiere ABI-Software] button under "Einzelplatzversion" and follow
the dialogue on the screen.
Installing the network version
1. Install the Firebird-DB-server locally on the server computer by clicking the
[Installiere Firebird-DB-Server] button (this step is not required if a Firebird server
is already running on the system). With active firewall, please define the TCP-port
3050 as an exception.
2. Then install the database file “ABI.fdb” locally on the server computer in a direc-
tory of your choice by clicking the [Installiere Datenbankdatei] button.
3. Then install the ABI software on each workstation PC required by clicking the
[Installiere ABI-Software] button.
Note
You will need to reboot the computer when the installation is complete.
After starting the ABI software for the first time as a network version, you will be
prompted to enter access data (on this occasion only).
These data are:
Server name: Your server’s computer name in the network

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10 Installing the USB connection cable
• Connect the apparatus to a free USB port on your PC.
• WINDOWS automatically detects the USB connection
Database file (Datenbankdatei): the target folder on the server\ABI.fdb
User name (Benutzername): sysdba (fixed)
Password (Passwort): masterkey (fixed)
The access data will be stored in the file ABI.ini; this information does not need to
be re-entered on start-up.
11 Using the ABI-system 100 software
Starting the program
Double click on the desktop symbol “boso ABI-system 100”
Calling up the Help function
Press the F1 key or the [Help] button at any time to call up these user instruc-
tions as a PDF file.
Configuration before first use
Before starting the boso ABI system 100, you can enter the following settings
([Settings...] button).

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Entering doctor’s data
The treating doctor’s
personal data can be entered
in the “Doctor” tab, which is
then used as the basis for the
printout footer.
Entering GDT files for incorporation in the practice EDP System
The “Import/Export” tab is
used to define the transfer files
for incorporation in the practice
EDP system.
The buttons next to the input
fields for the import
and export files
allow you to access the
Windows directory structure
directly.
boso import file = export file from the practice EDP system
boso export file = import file to the practice EDP system
Entering limits for the ABI assessment
The "ABI-calssification" tab
provides an option for altering
the limits for classifying the
ABI value.
NB:
Changes take effect only
after the program is restarted.

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Definition of output format
Use the “Printer settings”
tab to define whether the results
are output in paper format, as print
preview and/or as a PDF document
by clicking on the appropriate [Print...]
button during the program run.
If "Printer” is selected, click the [Print...]
button during the program run to display the
Output Options" dialogue. Here it is possible to
choose between "Printer" and "Preview". The "File"
function is redundant here.
If "PDF file" is selected, a PDF file is created (directory as defined under
[Settings…] (Einstellungen...) "Printer settings").
The file name for this PDF file is constructed as follows:
Output of patient data: ABI_pat#.pdf
Output of measurement data: ABI_pat#_YYYYMMDD_m. pdf
Output of profile: ABI_pat#_p.pdf
(pat# = patient number| YYYYMMDD = measurement date)
Note: at least one medium, “Printer” or "PDF file", must be selected.

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Patient tab
On starting the program you are
taken to the ABI patient manage-
ment screen. If the patient con-
cerned is already registered, click
on the listing to select them. If
the program was started from the
practice system, the patient will be
automatically selected or created
by GDT import.
To add a new patient in the ABI software,
select the [New ...] button in the "Patient"
tab. “Name” and “Patient No.” are obliga-
tory fields. The patient number is presen-
ted automatically, but can also be altered
manually.
You have the option here:
• to edit existing patients
• to delete existing patients
The measurement data of the selected patient can be exported to any directory in
Excel format using the [Export/Import] "Export Excel" button for further proces-
sing.
Complete patient data (master data and measurement data) can be transferred by
the [Export/Import] "Export Patient (ABI)" button in the format "abi_pat#" (pat# =
patient number)
The import function is available for reading in these data via [Export/Import] "Import
Patient (ABI)". Select the required patient number from the listed files in the format
"abi _pat#" (pat# = patient number).

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Measurement tab
Previous measurements can be
viewed and new measurements
taken in the "Measurements” tab.
To display previous ABI measure-
ments, select the required ABI
measurement in the “Date-Time”
field.
The following parameters will be displayed on screen (for the left and right side of
the body, respectively):
Sys systolic blood pressure of the upper arm, displayed in red if >140 mmHg
Dia diastolic blood pressure of the upper arm, displayed in red if > 90 mmHg
PP pulse pressure = difference between systole - diastole, displayed in red
if >54 mmHg
Pul pulse value in 1/min
Arr indicates whether a pulse rate irregularity of more than 25% occurred
during a measurement; red if “yes”, not if “no”)
ABI Ankle-Brachial Index = quotient of the systolic pressure of the leg
measurement and the higher systolic pressure of the arm measurements,
displayed in red in line with the settings under [Settings...]
“ABI assessment” (default <0.9)
Sys systolic blood pressure at the ankle
Note: If no measurement result is displayed for the systolic blood pressure at
the ankle, check the cuff and tubes and repeat the measurement. If still no mea-
surement result is displayed, this may indicate a circulatory disturbance or medial
sclerosis. Further investigations are advisable.
Diff Arm Sys difference between the systolic values of the left upper arm and
the right upper arm, displayed in red if > 19 mmHg
Diff Arm Dia difference between the diastolic values of the left upper arm and
the right upper arm, displayed in red if > 19 mmHg
Diff Leg Sys difference between the systolic values of the left
ankle and the right ankle, displayed in red if > 19 mmHg

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Profiles tab
The ABI values of all
measurements are displayed gra-
phically in the “Profiles” tab.
The colour mode is that set in “ABI
classification” (red: ABI < 0.9).
Click on one of the oscillation profiles to
enlarge the selected profile.
The “Pulse level / time” tab shows the oscillati-
on curve over the time axis.
The “Pulse level / cuff pressure” tab shows
the oscillation curve over the cuff pressure.

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12 Preparing for an ABI measurement
The measurement must be performed with the patient supine to ensure
comparable blood pressure conditions in arms and legs.
The patient should rest for about 5 minutes before a measurement is
taken.
Attaching the cuff
The device should only be used with original boso CA04 or CL04 cuffs
Type Circumference Order no.
Upper arm cuff CA04 22 - 42 cm 143-4-768
Ankle cuff CL04 18 - 38 cm 143-4-769
The cuffs are colour-coded. Attach the individual cuffs to both upper arms and both
ankles according to their colour coding (matching the symbols next to the air con-
nection sockets on the apparatus).
Attach the upper arm cuffs so that the lower edge of the cuff is
about 2-3 cm above the elbow joint.
The cuff should be positioned in such a way that the marking is
over the brachial artery.
Assignment of cuffs to limbs
Check that the cuffs are correctly assigned to the individual limbs by individual
measurements of the right or left arm and right or left leg.
Never place the metal ring over arteries, as this may produce an incorrect
reading.
Attach the ankle cuffs so that the lower edge of the cuff
is about 1-2 cm above the ankle joint.
The cuff should be positioned in such a way that the
yellow marking is over the posterior tibial artery.
Ensure that the cuff fits tightly at the ankle.

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13 Taking an ABI measurement
A measurement can be
cancelled at any time by clicking
on the [Cancel measurement]
button in the software or pressing
the STOP key on the apparatus;
all the cuffs deflate automatically.
Alternatively, the cuffs can be
removed from the limbs at any
time.
Select “Start new measurement” in the “Measurements” tab or press the START
button on the apparatus. The ABI-system 100 starts the ABI measurement after a
short calibration process (about 3 seconds).
The apparatus has an intelligent automatic inflation system to ensure comfortable
inflation to the correct cuff pressure. When the correct inflation pressure has been
reached, the pump will switch off and the cuffs will deflate automatically.
At this point (if not before) the patient must keep all four limbs completely
still and may not talk.
After the end of the measurement, the built-in valves open automatically and the
cuffs deflate rapidly.
The measurement values are displayed in the ABI software.
Individual comments can be added
for each ABI measurement taken
via the [Remarks...] button.
Comments templates can be
defined and saved for later use.

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Saving an ABI measurement
To save an ABI measurement, click on the [Save measurement] button.
Repeating an ABI measurement
Allow an interval or at least 2 minutes between successive measurements.
To repeat an ABI measurement press the [Start new measurement] button.
To take a measurement on one limb only, press the START key next to the corre-
sponding symbol.
When determining the ABI it is recommended to perform all measurements at the
same time.
If no further measurement is required, remove the cuffs from the limbs.
14 Incorporation in the practice EDP system via GDT interface
For incorporation in the practice EDP
system, define the relevant communication
pathways and import/export file names
under [Settings ...] "Import/Export".
Import occurs automatically on program
start-up. Export is performed manually via
the [Export GDT] button in the “Measure-
ments” tab or automatically on exiting the
program if a measurement has been
taken. Export is only possible after patient data has been successfully imported.

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15 Cleaning the apparatus and cuff
Please use only a soft, dry cloth to clean the device.
Small stains on the cuff can be carefully removed with a damp cloth.
16 Disinfecting the apparatus
We recommend Antifect® Liquid disinfectant (Schülke&Mayr) to wipe the appara-
tus and cuffs for disinfection.
17 Warranty and customer service
For details of the warranty conditions, please consult the warranty certificate sup-
plied.
A claim under warranty will only be accepted if the warranty certificate, completed
and stamped by the dealer, is returned with the device.
For warranty and repair work, please send the device, carefully packaged and with
sufficient postage, to your authorised dealer or directly to:
BOSCH + SOHN GmbH u. Co. KG
Bahnhofstraße 64
D-72417 Jungingen

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18 Technical data
Measurement principle: oscillometric
Measurement range: 40 to 240 mmHg
Cuff pressure: 0 to 300 mmHg
Maximum deviation of cuff ± 3 mmHg
pressure measurement:
Operating conditions: Environmental temperature 10 to 40°C
Relative humidity 10 to 85%
Transport and storage conditions: Environmental temperature -5°C to 50°C
Relative humidity max. 85%
Power supply: DC 5 V power supply unit, 2.7 A, AC 100-
240 V, 50-60 Hz, order no.: 410-7-154
Weight: 3.68 kg without power supply unit
Dimensions (W x H x D): 458 mm x 83 mm x 290 mm
Classification: Protection class II (Symbol )
Type BF (Symbol : )
Clinical test (DIN 58130): accuracy complies with the requirements
of EN 1060 part 3
Subject to technical modifications.
19 Instructions for disposal
This apparatus falls within the scope of EC Directive 2002/96/EC (WEEE). It is
not registered for use in private households and disposal via communal collection
sites for obsolete electrical apparatus is prohibited. Bosch + Sohn has commissi-
oned a company to dispose of the apparatus safely and legally. Please refer to the
address mentioned at the end of these user instructions for further information.