User instructions boso ABI-system 100 0124
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 • Installing the network version 9 9 10 Installing the USB connection cable 10 11 Using the ABI-sys
Contents 12 Preparing for an ABI measurement 16 • Attaching the cuff • Assigning cuffs to limbs 16 16 13 Taking an ABI measurement 17 • Saving an ABI measurement • Repeating an ABI measurement 18 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
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 certificate 1 User instructions 2 Minimum system requirements • Pentium II or higher • 256 MB RAM • Graphics card • 20 MB hard disk space • USB 1.
3 Explanation of symbols and operating controls Cuff connection Right arm (colour code red) Cuff connection Left arm (colour code yellow) Cuff connection Right leg (colour code black) Cuff connection Left leg (colour code green) 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.
4 Explanation of icons Read the user instructions Protection class II device Degree of protection against electric shock: type BF USB 2.0 connection 0124 The CE mark documents compliance with the Medical Devices Directive 93/42/EEC, Notified body: DEKRA, 0124 Year of manufacture Manufacturer Potential equalisation Do not dispose of this device in the domestic waste. For further information see page 20.
5 Preliminary remarks Your boso ABI-system 100 is an innovation on the market of blood pressure measurement 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.
• 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. 7 Ankle-Brachial Index (ABI) To determine the ABI value, the systolic blood pressure values of the arms and legs must be measured.
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.
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. 10 Installing the USB connection cable • Connect the apparatus to a free USB port on your PC.
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.
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.
Patient tab On starting the program you are taken to the ABI patient management screen. If the patient concerned 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 obligatory fields.
Measurement tab Previous measurements can be viewed and new measurements taken in the "Measurements” tab. To display previous ABI measurements, select the required ABI measurement in the “Date-Time” field.
Click on one of the oscillation profiles to enlarge the selected profile. The “Pulse level / time” tab shows the oscillation curve over the time axis. The “Pulse level / cuff pressure” tab shows the oscillation curve over the cuff pressure. Profiles tab The ABI values of all measurements are displayed graphically in the “Profiles” tab. The colour mode is that set in “ABI classification” (red: ABI < 0.9).
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.
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).
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 corresponding symbol. When determining the ABI it is recommended to perform all measurements at the same time.
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 apparatus and cuffs for disinfection. 17 Warranty and customer service For details of the warranty conditions, please consult the warranty certificate supplied.
18 Technical data Measurement principle: oscillometric Measurement range: 40 to 240 mmHg Cuff pressure: 0 to 300 mmHg Maximum deviation of cuff pressure measurement: ± 3 mmHg 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 100240 V, 50-60 Hz, order no.
20 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 [Settings …] button in the "Patient" tab to select “Test mode" and click on the “Start” button. 2.) After a short calibration process the apparatus will be in test mode.
21 EMC notes for your boso ABI-system 100 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.
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.
22 Your notes 24
Your notes 25
Your notes 26
Your notes 27
Subject to change without prior notification. Omissions and errors excepted. (08/05/2012) BOSCH + SOHN GmbH u. Co. KG Bahnhofstraße 64 • 72417 Jungingen • Germany Telefon: +49 (0) 74 77 / 92 75-0 • Fax: +49 (0) 74 77 / 10 21 www.boso.de • mail: zentrale@boso.
