Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Summary of Contents for Bosch+Sohn ABI Series
- Page 1 User manual boso ABI-Serie Ankle-brachial index measurement system...
-
Page 2: Table Of Contents
Table of contents Contents of package ................3 Explanation of symbols ..............3 Symbols on the measuring device............4 Device overview................4 Device overview | ....5 Front + back of the device....... Legend | ...............6 Software + ABI Preliminary remark ................7 Introduction ..................7 Intended use ..................8 Contraindications ................8... -
Page 3: Contents Of Package
Contents of package • 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 •... -
Page 4: Symbols On The Measuring Device
Fig. 1 Back of the device Fig. 2 boso ABI-system 100 00000000 0124 +E12047301410/$+47301492D boso ABI-system 100 BOSCH+SOHN GMBH U. CO. KG D- 72417 JUNGINGEN/Germany 00000000 boso AC-Adapter 410-7-154 DC5V / min. 2700mA 0124 +E12047301410/$+47301492D BOSCH+SOHN GMBH U. CO. KG... -
Page 5: Device Overview | Front + Back Of The Device
Device overview - Front of the device (Fig.1) 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. -
Page 6: Legend | Software + Abi
Legend - Software + ABI mmHg Pressure unit (millimetre mercury column) Systolic blood pressure in mmHg Diastolic blood pressure in mmHg Pulse pressure in mmHg Pulse pressure = Difference between systole - diastole Pulse value in 1/min Arrhythmia Indication of whether a pulse irregularity of over 25% was observed during the measurement Ankle-brachial index ABI = Ratio of systolic pressure of the leg measurement and... -
Page 7: Preliminary Remark
Preliminary remark 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. -
Page 8: Intended Use
“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. -
Page 9: Important Information
Important information 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. - Page 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.
-
Page 11: The Ankle-Brachial Index
The ankle-brachial index To determine the ABI value, the systolic blood pressure values of the arms and legs must be measured. Blood pressure readings are expressed in mmHg (mm mercury column). The ABI value is calculated as the ratio of the systolic pressure of the leg measurement (the averaged pressure of the posterior tibial artery and anterior tibial artery) and the higher systolic pressure of the arm measurements. -
Page 12: Preparation Of The Abi Measurement
Use only the boso power pack (art. no. 410-7-154). This power pack has been stabilised with regard to output, accurately set, and correctly polarised. Conventional power packs can damage the electronics and result in loss of the manufacturer's warranty. To establish equipotential bonding, connect a suitable conductor to the intended equipotential bonding on the device. -
Page 13: Fitting The Cuffs
Placing the cuffs The device may be used only with original boso cuffs CA04, CL04, CA02 or CA03. Type description Circumference Order no. Upper arm cuff CA04 22 - 42 cm 143 - 4 - 768 Ankle cuff CL04 18 - 38 cm 143 - 4 - 769 Upper arm cuff CA02... - Page 14 2-3 cm Right arm Fig. 4 2-3 cm 2-3 cm Artery Arterie Markierung Mark Place the ankle cuffs such that the lower edge of the cuff is approx. 1-2 cm above the ankle. Position the cuff such that the white mark is on the posterior tibial artery.
-
Page 15: Performing The Abi Measurement
Performing the ABI measurement A measurement can be discontinued at any time by pressing the “Cancel measurement” button in the software or the STOP button on the device; upon doing so, all cuffs will be automatically deflated. Alternatively, the cuffs can be removed from the limbs at any time. - Page 16 The integrated valves automatically open to rapidly deflate the cuffs once the measurement is complete. The measured values are displayed in the boso profil-manager XD. Individual remarks can be added for each measurement performed using the “Remarks” button. Remark templates can be defined and saved for later use. Screenshot | boso profi l-manager XD Fig.
- Page 17 Pulse value in 1/min Arrhythmia: Indication of whether a pulse irregularity of over 25% is observed during the measurement Display in red indicates arrhythmia Ankle-brachial index ABI = Ratio of the systolic pressure measured in the leg and the higher systolic pressure measured in the arm.
- Page 18 Storing the ABI measurement To store a measurement, click on the “Save measurement” button. The reading must be repeated if it is obviously incorrect! Blood pressure is a dynamic parameter and can be influenced by various factors, such as: • Movement before or during the measurement •...
-
Page 19: After Use
Performing a repeat ABI/PWV measurement A gap of at least 2 minutes must be left between 2 consecutive readings. To perform a repeat measurement, press the “ABI measurement” or “ABI+PWV measurement” button again. To perform a measurement on only one limb, press the START button next to the corresponding symbol. -
Page 20: Customer Information For Returning Commercial Waste Electrical Equipment
Customer information for returning commercial waste electrical equipment 1) Purpose Based on the EU directive 2012/19/EU, the German implementation for the Electrical and Electronic Equipment Act (ElektroG) was revised in 2021. The amended ElektroG3 took effect on 01/01/2022. The reason for this is to continuously improve the collection rates of electronic waste and achieve a rate of >... -
Page 21: Incident Reporting Obligation
Incident reporting obligation A serious incident is to be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is located. A “serious incident” denotes an incident which had, could have had, or could have one of the following consequences, directly or indirectly: Death of a patient, user, or another person;... -
Page 22: Warranty, Guarantee, Customer Service
Warranty, guarantee, customer service We provide a two-year manufacturer's warranty on this product from the date of purchase. The date of purchase must be shown by the invoice. Defects due to material or manufacturing errors are repaired free of charge within the warranty period. If parts are replaced under warranty, the warranty period is extended only for those parts, not for the entire device. -
Page 23: Technical Data
Technical data Principle of measurement: Oscillometric Type designation: boso ABI-Serie Measurement range 60 to 240 mmHg (blood pressure, SYS): Measurement range 40 to 140 mmHg (blood pressure, DIA): Cuff pressure: 0 to 300 mmHg Maximum cuff pressure ± 3 mmHg (max. difference right/ measurement deviation: left ±... -
Page 24: Metrology Test Instructions
Dimensions (W x H x D): 460 mm x 83 mm x 290 mm Classification: Protective class II (symbol: Type BF (symbol: Clinical test (DIN 58130): Accuracy of measurement complies with the requirements of EN 1060 part 3 Metrology test instructions A) Function test Function tests of the device can only be performed on a human subject or a suitable simulator. - Page 25 2.) After a brief calibration, the device is in test mode. The current pressure is displayed in the corresponding fields of the boso profil-manager XD. 3.) Carry out the pressure display deviation test and pressure circuit tightness test in the usual way, taking care to ensure that the cuff set-up time is at least 30 seconds.
-
Page 26: Emc Information Boso Abi-Serie
HF emissions according to CISPR 11 Class B Devices of the boso ABI series are intended for use in all facilities, including residential areas and areas Harmonic emissions according to Class A... - Page 27 Guidelines and manufacturer's declaration - electromagnetic emission The boso ABI-Serie devices are intended to be operated in the electromagnetic environment indicated below. The customer or user of the boso ABI-Serie device should ensure that it is used in such an environment. IEC 60601 Electromagnetic environment –...
- Page 28 BOSCH + SOHN GmbH u. Co. KG Bahnhofstraße 64 | 72417 Jungingen, Germany | T + 49 (0) 74 77 92 75 - 0 Email zentrale@boso.de | boso.de...
Need help?
Do you have a question about the ABI Series and is the answer not in the manual?
Questions and answers