Technical data

5 Preliminary remarks

Your boso ABI-system 100 is an innovation on the market of blood pressure mea-

surement 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. The great advantage of this type of

measurement is that there is no need for a microphone or amplifier which must be

positioned exactly if accurate results are to be obtained.

This system complies with the European directives on which the German Medical

Devices Act (CE mark: CE0124) is based and with European Standard EN 1060,

Part 1: “Non-invasive sphygmomanometers - General requirements” and Part 3:

“Supplementary requirements for electro-mechanical blood pressure measuring

systems”.

Calibration checks - every 2 years at the latest - can be performed either by

the manufacturer, or the trade measurement authorities, or persons who fulfil

the requirements of the legislation governing the operation of medical devices

(German Medical Devices Operator Ordinance section 6). Instructions for cali-

bration checks can be found on page 21 of these user instructions.

Medical electrical apparatuses are subject to specific precautions as regards elec-

tromagnetic compatibility and must therefore be installed and operated according

to the EMC instructions given on pages 22 and 23.

6 Important information

• The same exclusion criteria apply for oscillometric ABI measurements as for

Doppler measurements.

• Cardiac arrhythmias can interfere with the accuracy of a measurement and pro-

duce incorrect readings. Interference can also occur in wearers of pacemakers

if they have a weak pulse. The blood pressure monitor will have no effect on the

pacemaker, however.

Do not use the apparatus in patients with severe heart failure.

Do not use the apparatus unattended in unconscious, helpless or unresponsive

persons.

Do not place the cuffs over open wounds, implanted stents or lymphoedema.

Allow an interval of at least 2 minutes between 2 consecutive measurements.