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) 0124
Table of contents 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. Explanation of symbols and operating controls........................................ 4 Explanation of icons................................................................................ 5 Preliminary remarks................................................................................. 6 Important information............................................................................. 6 Ankle-Brachial Index (ABI).............
Contents of package 1 boso ABI-system 100 / boso ABI-system 100 PWV 2 CA04 upper arm cuffs 2 CL04 ankle cuffs 1 boso profil-manager XD 1 USB cable 3,0 m 1 boso power supply unit art. no.
1. 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 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.
2. 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 15.
3. 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 optional pulse wave velocity (PWV). The pressure variations (oscillations) caused by pulse waves and transmitted by the cuffs are stored and evaluated by microprocessors.
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).
7. 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.
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.
. 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 measurement” in the “Measurements” tab or press the START button on the apparatus.
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 ...
11. 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. 12. Disinfecting the apparatus We recommend Antifect® Liquid disinfectant (Schülke&Mayr) to wipe the apparatus and cuffs for disinfection. 13. Warranty and customer service For details of the warranty conditions, please consult the warranty certificate supplied.
Maximum deviation of puls measurement: ±5% Maximum deviation of PWV measurement: ±5% 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 100240 V, 50-60 Hz, order no.: 410-7-154 Weight: 3.
16. 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.
17. EMC notes for 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.
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Subject to change without prior notification. Omissions and errors excepted. (07/05/2014) 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.