Mobiclinic TX-01 - Intended Use; Product Description

Blood Pressure Monitor
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SWE
PL DKENES
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2. DISPLAY CONTENT AND INDICATORS
3. INTENDED USE
The fully automatic electronic sphygmomanometer is for use by medical professionals or
at home. It is a non-invasive blood pressure measurement system designed to measure the
systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive
technique, where an inatable cu is wrapped around the upper arm. The circumference of the
cu is limited to 22cm-42cm (approx. 8 21/32” - 16 17/32”).
This electronic sphygmomanometer is not suitable for people with severe
arrhythmias. It cannot be used near active HF SURGICAL EQUIPMENT and the
RF shielded room of an EM SYSTEM for magnetic resonance imaging, where the
intensity of EM DISTURBANCE is high.
4. PRODUCT DESCRIPTION
Thanks to the silicon oscillometric methodology and the integrated pressure sensor, blood
pressure and pulse can be measured automatically and non-invasively. The LCD display will
show blood pressure and pulse. The last 4x30 measurements can be stored in the memory
with date and time. The voice function will facilitate the operation.
The electronic sphygmomanometers correspond to the following standards: . IEC
60601-1Edition 3. 1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical equipment -- Part
1: General requirements for basic safety and essential performance), IEC60601-1-2:2014/EN
60601-1-2:2015 (Medical electrical equipment -- Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility - Requirements
and tests), IEC80601-2-30:2009+AMD1:2013/EN 80601-2-30:2010/A1:2015 (Medical electrical
equipment - Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers)EN 1060-1: 1995 + A2: 2009 (Non-invasive
Date and time
Voltage rating level
Systolic
Diastolic
Pulse
Air tube
input
Cu
Connector
LCD
display
On/O
Button
Memory
button
Pulse symbol
Deate remaining air
Low battery
Irregular heartbeat symbol