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User instructions
boso ABI-system 100
and
boso ABI-system 100 PWV
the powerful system for the early detection of PAD and
the determination of the pulse wave velocity (optional)
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Table of contents
1. Contents of package .............................................................................. 3
2. Purpose .................................................................................................. 3
3. Contraindications ................................................................................... 3
4. Explanation of symbols and operating controls ....................................... 4
5. Explanation of icons ............................................................................... 5
6. Preliminary remarks ................................................................................ 6
7. Important information ............................................................................ 6
8. Ankle-Brachial Index (ABI) ....................................................................... 7
9. Pulse wave velocity (PWV) ...................................................................... 7
10. Turning the device on ............................................................................. 8
11. Installation and operation of the software............................................... 8
12. Preparing for an ABI / PWV measurement ............................................... 8
13. Taking and ABI / PWV measurement ..................................................... 10
14. Cleaning the apparatus and cuff ........................................................... 12
15. Disinfecting the apparatus and cuff ...................................................... 12
16. Warranty and customer service ............................................................. 12
17. Technical data ...................................................................................... 12
18. Instructions for disposal ........................................................................ 13
19. Calibration checks – Testing instructions ............................................... 14
20. EMC notes ........................................................................................... 15
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1. Contents of package
1 boso ABI-system 100 / boso ABI-system 100 PWV
2 CA04 upper arm cuffs
2 CL04 ankle cuffs
1 bosoprol-managerXD
1 USB cable 3,0 m
1 boso power supply unit art. no.: 410-7-154
1 Warrantycerticate
1 User instructions boso ABI-system 100 / boso ABI-system 100 PWV
1 Userinstructionsbosoprol-managerXD
2. Purpose
Non-invasive measurement of systolic and diastolic blood preasure on the following
limbs: arm left, arm right, ankle left, ankle right. The theraby determinated Ankle
Brachial Index (ABI) is utilised as an indication of the prevalence of peripheral arterial
disease.
In addition to the ABI-measurement optionally via a second measurement the pulse
wave velocity (PWV) is determined. The PWV is an indicator of arterial stiffness. A
stiff vessel expands less than an elastic vessel and therefore has a higher pulse wave
velocity.
3. Contraindications
• For the oscillometric ABI measurement, the same exclusion criteria apply as for the
doppler measurement.
• The device is not suitable for newborns and infants.
• Do not use the device in patients with severe heart failure.
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4. Explanation of symbols and operating controls
Cu connection
Right arm
(colour code red)
Cu connection
Right leg
(colour code black)
Cu connection
Left arm
(colour code yellow)
Cu connection
Left leg
(colour code green)
START key
Press this key to start a easurement 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 a single measurement
These keys enable the user to start individual measurements of the limbs.
Power on indicator
The green light is illuminated when power is supplied to the device.
To disconnect the instrument from the mains voltage, unplug the
AC-adapter from the wall socket.
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5. Explanation of icons
Read the user instructions
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
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Directive 93/42/EEC,
Notified body: DEKRA, 0124
Manufacturer
2018
Year of manufacture
Potential equalisation
Do not dispose of this device in the domestic waste.
For further information see page 13.
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6. Preliminary remarks
Your boso ABI-system 100 is an innovation on the market of blood pressure
measurement technology for medical professionals. It provides a simple way of determining the ankle-brachial index (ABI) and optional pulse wave velocity (PWV). 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 calibration checks
can be found on page 14 of these user instructions.
Medical electrical apparatuses are subject to specific precautions as regards electromagnetic compatibility and must therefore be installed and operated according to
the EMC instructions given on page 15.
7. 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 produce
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.
• The device is suitable for patients of all ages, whose upper arm circumferences are
between 22 and 48 cm and ankle circumferences are between 18 and 38 cm.
• The device is not suitable for newborn babies.
• 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.
• Make sure that the tubes are not kinked during the measurement. A congestion
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could lead to injuries.
• During measurement the flow of blood must not be stopped any longer than
necessary (> 2 minutes). In case of a malfunction of the device, take off the cuffs
from the arms and legs.
• Too many measurements may lead to impairment of blood flow and thus to injries.
• The cuff should not be applied on wounds, as this may cause further injuries.
• Make sure the cuff is not applied to an arm or leg which arteries or veins are or
have been under medical treatment (e.g. shunt).
• Women with mastectomy should not have a cuff on the arm at the side where the
breast has been amputated.
• During the measurement, a malfunction may occur in other medical devices which
are applied simultaneously on the same arm.
• Operating the device in the vicinity of strong electromagnetic fields (e.g. radiation
devices, mobile phones) can cause it to malfunction (see page 15).
• 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.
• The instrument has to be installed in a way that the plug of the power supply
is easily accessible.
8. 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 measurement
(the mean pressure of the posterior and anterior tibial arteries) and the higher systolic
pressure of the arm measurements.
9. Pulse wave velocity (PWV) (optional)
The pulse wave velocity is calculated using the pulse transit time between upper arm
and ankle, and body size. The measured values are given in m / s (meters per second).
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10. 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.
To establish the potential equalization connect an appropriate wire to the relevant
potential compensation of the unit. Furthermore the requirements of EN 606011:2006 apply for potential compensation.
The bonding conductor shall not be used as a protective conductor
connection.
11. Installation and operation of the software of the ABI-system 100
see user instruction / installation guide of boso profil-manager XD
12. Preparing for an ABI / PWV (optional) measurement
The measurement must be performed with the patient supine to ensure
comparable blood pressure conditions in arms and legs. The legs must
not be crossed.
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, CA03, CA02 or
CL04 cuffs.
Type Circumference Order no.
Upper arm cuff CA04
Upper arm cuff CA03
Upper arm cuff CA02
22 - 42 cm
16 - 22 cm
32 - 48 cm
143-4-768
143-4-773
143-4-771
Ankle cuff CL04 18 - 38 cm 143-4-769
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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 connection
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.
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
white marking is over the posterior tibial artery.
Ensure that the cuff fits tightly at the ankle.
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.
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13. Taking an ABI / PWV (optional) 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 measure ment” 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.
(optional)
Select "ABI + PWV measurement" in the registry "data" or press the START button
on the unit. The ABI-system 100 starts the ABI measurement after a short calibration
procedure (about 3 seconds). Upon completion of the ABI measurement and another
break (about 10 seconds) the PWV measurement is started.
After the measurement the valves are opened automatically to allow rapid deflation
ofthecuffs.ThemeasuredvaluesaredisplayedintheprofilmanagerXD.
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Individual comments can be added for each ABI measurement via the "Remarks..."
button. Templates can be defined and stored for later usage.
Saving an ABI / PWV (optional) measurement
To save an ABI measurement, select "Save measurement".
The measurement must be repeated if the results are obviously wrong
Blood pressure is a dynamic parameter and can be influenced by various
effects:
- movement before or during the measurement
- physical condition (stress, illness ...)
Repeating an ABI / PWV (optional) measurement
Allow an interval or at least 2 minutes between successive measurements.
To repeat an ABI measurement select "ABI measurement" or "ABI + PWV measurement".
To take a measurement on one limb only, press the START key next to the corresponding 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.
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14. 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.
15. Disinfecting the apparatus
We recommend Antifect® Liquid disinfectant (Schülke&Mayr) to wipe the apparatus
and cuffs for disinfection. To disinfect the cuff, we recommend spray disinfection.
16. Warranty and customer service
We give 2 years warranty from the date of purchase. The purchase date has to be
proven by the invoice. Within the warranty period defects are eliminated free of charge. After repairs the warranty period is not extended on the whole unit, but only to
the replaced components.
Excluded from the warranty are parts subject to normal wear and tear (e.g. cuff),
transport damages and any damage caused by improper handling (e.g. non-compliance with the instructions for use). Damages due to disassembly by unauthorized
persons are also excluded from warranty.
No claims for damages against us are substantiated by the warranty. In the case of
justified warranty claims the device has to be sent along with the original invoice to:
BOSCH + SOHN GMBH U. CO. KG
Bahnhofstr. 64
D-72417 Jungingen
This device must be maintained by trained and approved staff.
Do not modify this equipment without authorization of the manufacturer.
17. Technical data
Measurement principle: oscillometric
Measurement range: 60 to 240 mmHg
(bloodpressure, SYS)
Measurement range: 40 to 140 mmHg
(bloodpressure, DIA)
Cuff pressure: 0 to 300 mmHg
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Maximum deviation of cuff ± 3 mmHg
pressure measurement: (max. difference right/left ± 2 mmHg)
Measurement range puls: 30 to 190 puls/min.
Maximum deviation of ± 5 %
puls measurement:
Maximum deviation of ± 5 %
PWV measurement:
Operating conditions: Environmental temperature +10 to +40°C
Relative humidity 30 to 85%
Transport and storage conditions: Environmental temperature -10 to +60°C
Relative humidity 30 to 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: 3.7 kg without power supply unit
Dimensions (W x H x D): 460 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.
18. 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 commissioned 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.
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19. Calibration checks – Testing instructions
Function testing
Function testing of the device can only be carried out on a person or with a suitable
simulator.
Testing of pressure circuit integrity and deviation of pressure display
1.) Use the "Pressure sensors A"or
"Pressure sensors B" button in
sub-registry "Test mode" to
start the test mode.
2.) After a short calibration process the apparatus will be in test mode. The
current pressure will be displayed in the corresponding boso profil-manager
XDfields.
3.) Perform the usual test for deviation of pressure display and pressure cir-
cuit integrity (allow a set-up time of at least 30 seconds for the cuff).
Maximum difference of the pressure right - left ± 2 mmHg.
4.) Run the test for all 4 limbs.
5.) Exit test by pressing the “Finish test” button.
The activation of the “pressure sensors B” is only possible for devices with a
serial number upper 46620000 and upper 47300000.
Safety seal
As a safeguard, the upper and lower parts of the housing can be joined with a safety
seal. The unauthorized destruction of the hedging mark voids the warranty.
(optional)
The testing of the "PWV"-function requires specialized simulators and can just be
done by the manufacturer.
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20. EMC notes for boso ABI-system 100 / boso ABI-system 100 PWV
Guidance and manufacturer’s declaration – electromagnetic emissions
The boso ABI-system 100 (PWV) is intended for use in the electromagnetic environment specified below. The customer of the user of the
Aussendungs-Messungen Übereinstimmung Elektromagnetische Umgebung-Leitlinien
RF emissions
CISPR 11
boso ABI-system 100 (PWV) should assure that it is used in such an environment.
Group 1 The boso ABI-system 100 (PWV) uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Class B The boso ABI-system 100 (PWV) is suitable for use in all establishments,
Class A
Complies
including domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for domestic
purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
The boso ABI-system 100 (PWV) is intended for use in the electromagnetic environment specified below. The customer or the user of the
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst IEC 610004-4 (100kHz)
Surges IEC 610004-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
boso ABI-system 100 (PWV) should assure that it is used in such an environment.
IEC 60601-
test level
± 8 kV
contact
± 15 kV
air
± 2 kV
power supply lines
± 1 kV
input/output lines
± 1 kV
differential mode
± 2 kV
common mode
Test level - % Uref
A/A 30
A/A 100
A/A 100
C/C 100
30A/m 30A/m
Compliance level Electromanetic environment - guidance
± 8 kV
contact
± 15 kV
air
± 2 kV
power supply lines
± 1 kV
input/output lines
± 1 kV
differential mode
± 2 kV
common mode
Duration s / Phase °
0.50 (0)
0.01 (0, 45, 90,
135, 180, 225, 270,
315)
0.02 (0)
5.00 (0)
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment.
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the boso ABI-system 100
(PWV) requires continued operation during power mains interruptions, it is recommended that the boso ABI-system 100 (PWV) has
to be powered from a uninterruptible power supply or a battery.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The boso ABI-system 100 (PWV) is intended for use in the electromagnetic environment specified below. The customer or the user of the
Immunity test IEC 60601 test
Conducted IEC
61000-4-6
and ISM & radio
band
(6V
)
rms
Spot-frequency:
380 MHz bis
5800MHz
Radiated RF
IEC 61000-4-3
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d
is the ecommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, a hould be less than the compliance level in each frequency range.b Interference may occur in the
vicinity of equipment marked with the following symbol:
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.
a
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
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which
the boso unit is used exceeds the applicable RF compliance level above, the boso unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such als re-orienting or relocating the boso ABI-system 100 (PWV).
level
3 V
ISM: 0,15 MHz bis
80MHz
radio band:
0,15 MHz bis
80 MHZ
6V
3V
150kHz bis 80MHz
boso unit should assure that it is used in such an environment.
Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be
used no closer to any party of the boso ABI-system 100 (PWV),
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
/m
rms
/m 6V
rms
/m
rms
3 V
/m
rms
ISM: 0,15 MHz bis
80MHz
radio band:
0,15 MHz bis
80 MHZ
/m d = 1,2 √P
rms
3V
/m
rms
150kHz bis 80MHz
d = 1,2 √P
d = 1,2 √P 80 MHz to 800 MHz
Recommended separation distances between portable and mobile RF communications equipment and the
boso ABI-system 100 (PWV)
The boso ABI-system 100 (PWV) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the boso ABI-system 100 (PWV) can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the boso ABI-system 100 (PWV) as recommended below,
Rated maximum
output
power of trans-
mitter
W
according the the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
150 kHz bis 80 Mhz
d= 1,2 √P
80 Mhz bis 800 MHz
d= 1,2 √P
800 Mhz bis 2,5GHz
d= 2,3 √P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitter 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 the 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 absorption and reflection from structures, objects and people.
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Your notes:
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Your notes:
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Your notes:
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BOSCH + SOHN GmbH u. Co. KG
Bahnhofstrasse 64 • 72417 Jungingen • Germany
Phone: +49 (0) 74 77 / 92 75-0 • Fax: +49 (0) 74 77 / 10 21
www.boso.de • mail: zentrale@boso.de
Subject to change without prior notication. Omissions and errors
excepted. (10/01/2018)
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