Intended Use; Product Description - Joycare JC-1321 Manual Del Usuario

INTENDED USE

The fully automatic electronic sphygmomanometer is for use at home. It is a non-invasive blood
pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse
rate of an adult individual by using a non invasive technique in which an inflatable cuff is wrapped
around the upper arm. The cuff circumference is limited to 22 cm - 30 cm.
CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this Electronic Sphygmomanometer.

PRODUCT DESCRIPTION

Based on Oscillometric methodology and silicon integrated pressure sensor, blood pressure and pulse
rate can be measured automatically and non-invasively. The LCD display will show blood pressure and
pulse rate. The most recent 2x60 measurements can be stored in the memory with date and time stamp.
The monitor can also show the average reading of the last three measurements.
The Electronic Sphygmomanometers corresponds to the below standards: IEC 60601- 1:2005/EN
60601-1:2006/AC:2010 (Medical electrical equipment -- Part 1: General requirements for basic safety
and essential performance), IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical electrical
equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility – Requirements and tests), IEC 80601-2- 30:2009+Cor.2010/
EN 80601-2-30:2010 (Medical electrical equipment –Part 2-30: Particular requirements for the basic
safety and essential performance of automated non-invasive sphygmomanometers) EN 1060-1:
1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements), EN
1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems).
SPECIFICATIONS
1. Product name: Blood Pressure Monitor
2. Model: JC-1321 (KD-558)
3. Classification: Internally powered, Type BF applied part, IPX0, No AP or APG, Continuous operation
4. Device size: Ca. 138 mm x 48 mm x 98 mm
5. Cuff circumference: 22 cm-30 cm
6. Weight: Approx. 211 g (batteries and cuff excluded)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 2 users x 60 measurements with time and date stamp
9. Power source: Batteries: 4 x 1.5 V
10. Measurement range:
Cuff pressure: 0 – 300 mm Hg
Systolic: 60 – 260 mm Hg
Diastolic: 40 – 199 mm Hg
Pulse rate: 40 – 180 beats/minute
11. Accuracy:
Pressure: 3 mm Hg
Pulse rate: 5 %
12. Environmental temperature for operation: +10 °C to +40 °C (50 °F to 104 °F)
13. Environmental humidity for operation: ≤ 90 % RH
14. Environmental temperature for storage and transport: -20 ° to 55 °C (-4 ° to 131 °F)
15. Environmental humidity for storage and transport: ≤ 90 % RH
16. Environmental pressure: 80 kPa to 105 kPa
type AA
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