Bosch+Sohn ABI Series User manual
User manual
boso ABI-Serie
Ankle-brachial index measurement system
EN
2
Contents of package ........................................................................3
Explanation of symbols ....................................................................3
Symbols on the measuring device......................................................4
Device overview................................................................................4
Device overview | Front + back of the device. ....................... ........................5
Legend | Software + ABI.......................................................................6
Preliminary remark ...........................................................................7
Introduction .....................................................................................7
Intended use....................................................................................8
Contraindications.............................................................................8
Important information ......................................................................9
The ankle-brachial index.................................................................11
Using the device for the first time ...................................................11
Preparation of the ABI measurement ..............................................12
Fitting the cuffs..............................................................................13
Performing the ABI measurement ...................................................15
After use........................................................................................19
Customer information | for returning commercial waste electrical equipment..20
Incident reporting obligation ..........................................................21
Warranty, guarantee, customer service ............................................22
Technical data................................................................................23
Metrology test instructions .............................................................24
EMC information boso ABI-Serie.....................................................26
Table of contents
3
• System for determining the ankle-brachial index (ABI)
• Carrying case
• Power pack
• Upper arm cuffs | 2 cuffs (arm circumference 22 – 42 cm), incl. tube
• Ankle cuffs | 2 cuffs (leg circumference 18 – 38 cm), incl. tube
• User manuals for:
- boso ABI-Serie
- profil-manager XD
• Medical device book
• Guarantee certificate
• CD-ROM
- boso profil-manager XD
• USB cable 3.0 m
• Brochures + poster
Contents of package
Date of manufacture
Explanation of symbols
Important information/warnings Order number
Store dry
Air humidity limit
Switzerland – authorisation
Read the electronic user manual
Medical device
Temperature limits
Fragile, handle with care
Action note for the user
4
CE mark
USB connection
Equipotential bonding
Serial number
Symbols on the measuring device
Degree of electrical shock protection: Type BF
Protection class II device
8
DE
Symbol Funktion/Bedeutung
Systolischer Blutdruck in mmHg
Diastolischer Blutdruck in mmHg
Puls pro Minute
Gerät ist konform mit der europäischen
Medizinprodukterichtlinie.
Gerät darf nicht über den Hausmüll entsorgt werden.
Hersteller
Gebrauchsanweisung lesen
Polarität der Netzgerätanschlussbuchse
SYS
DIA
PUL
0124
Symbole auf dem Blutdruckmessgerät
_boso_medicusX_1711sd.qxd:Layout 1 15.11.2017 13:43 Uhr Seite 8
The device may not be discarded
via household waste
8
DE
Symbol Funktion/Bedeutung
Systolischer Blutdruck in mmHg
Diastolischer Blutdruck in mmHg
Puls pro Minute
Gerät ist konform mit der europäischen
Medizinprodukterichtlinie.
Gerät darf nicht über den Hausmüll entsorgt werden.
Hersteller
Gebrauchsanweisung lesen
Polarität der Netzgerätanschlussbuchse
SYS
DIA
PUL
0124
Symbole auf dem Blutdruckmessgerät
_boso_medicusX_1711sd.qxd:Layout 1 15.11.2017 13:43 Uhr Seite 8
Manufacturer Read user manual
Device overview
Unique device identification
Fig. 1
boso ABI-system 100
boso AC-Adapter
410-7-154
DC5V / min. 2700mA
BOSCH+SOHN GMBH U. CO. KG
D- 72417 JUNGINGEN/Germany
00000000
0124
+E12047301410/$+47301492D
Front of the device
boso ABI-system 100
boso AC-Adapter
410-7-154
DC5V / min. 2700mA
BOSCH+SOHN GMBH U. CO. KG
D- 72417 JUNGINGEN/Germany
00000000
0124
+E12047301410/$+47301492D
Back of the device Fig. 2
5
Cuff connections
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)
START button
A measurement can be started manually using this button.
All 4 cuffs will be inflated.
STOP button
The measurement can be manually discontinued using this button.
All cuffs will be deflated and the display switched off.
Buttons to start an individual measurement
Individual measurements on the limbs can be started using these buttons.
Operating display
The display is lit and green as soon as the device is supplied with operating voltage.
To completely disconnect the device from the mains voltage, pull the power pack
out of the socket.
Read user manual
USB connection for type B plug
Mains connection
Equipotential bonding
Device overview - Front of the device (Fig.1)
Device overview - Back of the device (Fig.2)
6
Legend - Software + ABI
mmHg Pressure unit (millimetre mercury column)
Sys Systolic blood pressure in mmHg
Dia Diastolic blood pressure in mmHg
PP Pulse pressure in mmHg
Pulse pressure = Difference between systole - diastole
Pul Pulse value in 1/min
Arr Arrhythmia
Indication of whether a pulse irregularity of over 25% was
observed during the measurement
ABI Ankle-brachial index
ABI = Ratio of systolic pressure of the leg measurement and
higher systolic pressure of the arm measurements
baPWV Pulse wave velocity at the upper arm-ankle
cfPWV Pulse wave velocity between carotid aorta and femoral aorta
∆ Arm Sys Diff Arm Sys in mmHg
Difference between the systolic values of the left and
right upper arm
∆ Arm Dia Diff Arm Dia in mmHg
Difference between the diastolic values of the left
and right upper arm
7
Introduction
Please read this user manual carefully before initial use.
This user manual is a part of a modular system comprising two parts:
• User manual for boso ABI-Serie
• User manual for boso profil-manager XD
To be able to use all of the device functions of the boso ABI-Serie, please
use both of the available user manuals.
Please familiarise yourself with both user manuals before initial use.The
manufacturer reserves the right to modify the information in this user
manual without notice.The current version can be downloaded from the
website: https://www.boso.de/downloads
Dear Customer,
We are pleased that you have decided to purchase a system to measure
the ankle-brachial index.
Your boso ABI-Serie device is an innovation on the market of blood
pressure measurement technology for medical professionals. It easily
measures the ankle-brachial index (ABI). The system works according
to the oscillometric measurement principle. The pressure fluctuations
(oscillations) caused by the pulse waves and transferred from the cuffs
are stored and evaluated by the microprocessors. The major advantage
of this measurement method is that it does not require any microphone
or Doppler which need precise positioning in order to ensure the
reliability of the readings.
This blood pressure monitor complies with the current European
regulations as well as international standard IEC 80601-2-30:
Preliminary remark
8
Non-invasive recording of the systolic and diastolic blood pressure value
at the limbs: left upper arm, right upper arm, left ankle, right ankle.The
ankle-brachial index (ABI) that can be determined as a result is used to
indicate the presence of peripheral arterial occlusive disease.
Contraindications
“Particular requirements for basic safety and essential performance of
automated type non-invasive sphygmomanometers.”
The metrology test – every 2 years at the latest – can be performed by
the manufacturer, the authority responsible for metrology, or persons
who meet the requirements of the German Medical Device Operator
Ordinance (MP-BetreibV), section 6. The instructions for the metrology
test can be found in the chapter “Metrology test instructions” of this
manual.
Medical electrical devices are subject to particular precautions in
relation to electromagnetic compatibility and must be installed and put
into operation in accordance with the EMC information given.
The operating instructions must be kept together with the product
so that they are available at all times.
The icon in this manual indicates an action to be taken by the user.
Intended use
The same exclusion criteria apply to the oscillometric ABI
measurement as to a Doppler measurement.
Do not use the device on patients with severe heart failure.
The device is not suitable for infants and toddlers.
9
Cardiac arrhythmia can impair the measurement accuracy of the
device and lead to faulty measurements.
Adverse effects may occur in persons with cardiac pacemakers if
they have a weak pulse.
The device is suitable for patients of any age whose upper
arm circumference is between 22 and 48 cm and whose ankle
circumference is between 18 and 38 cm.
The device was not validated for use in pregnant women.
Do not use the device unattended on unconscious, helpless, or
unresponsive persons.
Do not place the cuffs over open wounds, implanted stents, and
lymphoedema.
When performing consecutive measurements, wait at least 2
minutes between each measurement.
Make sure that the air tube is not kinked during the reading. The
resultant blood congestion could cause injury.
The process of taking blood pressure must not stop the circulation
for an unnecessarily long time (more than 2 minutes). In the
event of device malfunction, press the Stop button and remove
the cuffs from the limbs.
In the case of a patient with limited cognitive ability, the
measurement should be performed only under supervision by
medical staff.
The long 2 m and 3.5 m cuff tubes present a risk of strangulation.
Excessively frequent readings can impair circulation and
consequently lead to injury.
Important information
10
The cuff must not be fitted over wounds as this could lead to
further injury.
Ensure that the cuffs are not placed on an arm or leg of which
the arteries or veins are undergoing or have undergone medical
treatment, e.g. a shunt.
In the case of women who have had a mastectomy, the cuffs
should not be placed on the arm on the side from which the
breast has been removed.
Medical devices being used on the same arm at the same time
may malfunction.
Operation in the vicinity of strong electromagnetic fields (e.g. due
to radiation devices, mobile phone(s)) can cause malfunction (see
EMC information).
The computer used for the evaluation must meet the requirements
according to EN 60601-1.
If you sell the device, the following must be included:
- User manual for boso ABI-Serie
- User manual for boso profil-manager XD, incl. software
The device must be set up such that the plug of the power pack
is easily accessible.
The performance of the device can be affected by excessive
temperature, humidity or altitude.
If the device was exposed to moisture or if liquid got into the device
during cleaning/use, no measurements should be performed on
the patient.
The manufacturer is only liable for effects on the safety, reliability and
performance of the device if:
assembly, extensions, reinstallation, alterations or repairs have
been carried out by individuals approved by the manufacturer.
the device is used in accordance with the manual.
This manual suits for next models
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Table of contents
