User instructions for the ABI-system 100 0124
User instructions for the ABI-system 100 1 ABI-system 100 2 CA04 cuffs (for upper arms) 2 CL04 cuffs (for legs) 1 ABI-system 100 software 1 USB cable 1 boso mains power supply art. no.
Explanation of symbols and user controls Cuff connection Right arm (Red colour code) Cuff connection Left arm (Yellow colour code) Cuff connection Right leg (Black colour code) Cuff connection Left leg (Green colour code) START key Press this key to start an ABI measurement. All 4 cuffs will be inflated. STOP key Press this key to cancel an ABI measurement. All of the cuffs will be deflated and the display will be switched off.
Explanation of symbols used Read the user instructions! Class II device Protection level against electric shock: Type BF USB 2.0 Connection 0124 The CE symbol is proof of compliance with Directive 93/42/ EEC concerning medical devices, Notified body: DEKRA, 0124 Year of manufacture Potential equalisation This device falls within the scope of EU Directive 2002/96/EC (WEEE). It is not registered for use in private households.
Introductory information Your boso ABI-system 100 is an innovation on the market for blood pressure measurement. It represents an easy way to determine the ankle-brachial index (ABI) and works according to the oscillometric measurement principle. The pressure variations (oscillations) caused by the pulse waves and transmitted by the cuffs are saved and evaluated by the microprocessors.
• The computer used to evaluate the readings must meet the requirements set out in EN 60601-1. • The instrument can only be operated together with the enclosed software. ABI The systolic blood pressure values of a person’s arms and legs need to be measured in order to determine the ABI value. The blood pressure measurements are stated in mmHg. The ankle-brachial index (ABI) is calculated as a quotient of the systolic pressure from the leg measurement (the higher pressure in A. tibialis posterior and A.
Installing the network version Firstly you need to install the Firebird database server locally on the server by clicking the button “Installiere Firebird DB-Server” (this step is not required if a Firebird server is already running on this system). Then install the database file “ABI.fdb” locally on the server in a directory of your choice by clicking the button “Installiere Datenbankdatei”. Then install the ABI software on each required workstation PC by clicking the button “Installiere ABI-Software”.
Database File: The target folder for the server\ABI.fdb Username: sysdba (fix) Password: masterkey (fix) The access data will be saved in the ABI.ini file; this information does not need to be entered again during startup. Installing the USB connection cable • Connect the USB connection cable to a free USB port on your PC.
Entering doctor’s data: The personal data of the doctor in charge can be entered in the “Doctor” tab which is then used as the basis for the printout footer: Adding GDT files for integration in the Doctors Patient System: The “Import/export” tab is used to define the transfer files for integration in the Doctors Patient System.
Assignment of the cuffs to the extremities.: Check the correct assignment of the cuffs to the extremities by seperate measurements of left arm, right arm, left leg and right leg. Using the program: Patient tab: After starting the program you will be taken to the ABI patient management screen. If the patient is already registered, select him or her by clicking on the listing with the mouse.
Measurement tab: Performed measurements can be viewed in the “Measurements” tab. If several measurements have already been carried out, select the desired ABI measurement in the “Date-time” field.
Click on one of the oscillation profiles to enlarge the view of the selected profile. The “Pulse level over time” tab shows the oscillation curve over the time axis. The “Pulse level over cuff pressure” shows the oscillation curve over the cuff pressure. “Profiles” tab: The ABI values of all measurements are displayed as graphs in the “Profiles” tab. The blue bar represents the ABI value of the first measurement, the red bar the ABI value of the second measurement.
Preparing for a measurement The measurement must be performed on a patient who is lying down in order ensure equal blood pressure among all limbs. The patient should lie down for approx. 5 minutes before taking a measurement. Fixing the cuff The cuffs are colour coded. Affix the cuffs on both upper arms and both ankles according to their colour coding (matching the symbols next to the air connection sockets on the device).
Taking a measurement In order to add a new patient in the ABI software, select the “New” button in the “Patient” tab. “Name” and “Patient no.” are obligatory fields. Select “NStart new measurement” in the “Measurements” tab or press the START button on the device. The ABI-system 100 starts the ABI measurement after a short calibration procedure (approx. 3 seconds). Press the START key on the ABI-system 100.
The decreasing cuff pressure will be displayed during the measuring phase. By this time (at the latest) all four limbs have to be kept absolutely still and the patient must not talk. Once the measurement has finished, the integrated valves will open automatically to quickly deflate the cuffs. The measured values are displayed in the ABI software. The measurement will be displayed on the screen and so the user can check the measurement, and it is automatically transferred to the ABI software.
Repeating a measurement In order to repeat a measurement, press the START key on the ABI-system 100 again. The previous measurement will be overwritten. In order to perform a measurement on one limb, press the Start new measurement” button again. However it is recommended to perform all measurements at the same time. If no other measurement is required, remove all of the cuffs from the limbs. The current measurement results will be displayed until the device is turned off by pressing the STOP key.
The times above the measurement value columns indicate the time of measurement (1st and 2nd measurement). Cancelling a measurement A measurement can be cancelled at any time by clicking the “Cancel measurement” button in the software or pressing the STOP key on the device, which in turn automatically deflates all of the cuffs. Alternatively, the cuffs can be removed from the limbs at any time. Cleaning the device and cuffs Please only use a soft, dry cloth to clean the device.
Technical data Measurement method: oscillometric Measurement range: 40 – 240 mmHg Cuff pressure: 0 – 300 mmHg Display: LCD Operating conditions: Ambient temperature 10°C to 40°C Rel. humidity 10 to 85% Transport and storage conditions: Ambient temperature -5°C to + 50°C Rel. humidity max. 85% Power supply: Mains power supply DC 5V, AC 100-240V, 50-60 Hz, 2700mA, order no.: 410 – 7 – 154 (Polarity: outer MINUS, inner PLUS) Weight: 3.
Technical testing procedure A) Function testing Function testing of the device can only be performed on human subjects or using a suitable simulator. B) Leak testing of the pressure circuit and display error testing Note: If the pressure during measuring mode increases to more than 320 mmHg, the quick deflate valve will be activated and the pressure circuit will be opened. The measurement value display will also blink if the pressure exceeds 320 mmHg when in test mode. Testing: 1.
EMC-notes for your ABI-system 100 Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according the EMC information provided in the following. Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment. The use of accessories and cables other than those specified (other than boso original parts) may result in increased emissions or decreased immunity of the unit.
Guidance and manufacturer’s declaration – electromagnetic immunity The boso unit is intended for use in the electromagnetic environment specified below. The customer or the user of the boso unit should assure that it is used in such an environment.
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Your notes: 23
Subject to change without prior notification. Omissions and errors excepted. (09/2008) BOSCH + SOHN GmbH u. Co. KG Bahnhofstraße 64 • 72417 Jungingen • Germany Phone: +49 (74 77) 92 75-0 • Fax: +49 (74 77) 10 21 Internet: www.boso.de • e-Mail: zentrale@boso.
