3)
Measurement: Oscillometric method with automatic inflation and controlled pressure release valve.
4)
Measurement range: 40~250 mmHg for blood pressure, 40~200 beats/minute for pulse.
5)
Technical measuring precision:
Cuff pressure Accuracy: ±3mmHg or ±2% of readout value for blood pressure. ±5% of readout for pulse.
6)
Measurement resolution: 1mmHg for blood pressure. 1 beat/min for pulse.
7)
Power source: 4 x 1.5V Batteries; size AAA, supplied.
8)
Operating conditions: 10~40C (50~104F) temperature, 15~90% relative maximum humidity, atmospheric
pressure 86Kpa~106kpa, maximum altitude: 2000m.
9)
Storage and transport conditions: -25~70C (-13~158F) temperature, 10~95% relative maximum humidity,
atmospheric pressure 86Kpa~106kpa, maximum altitude: 2000m.
10)
Compatibility: iPhone 4S or later, iPad 4th generation or later, iPad mini, iPod Touch 5th generation or
later. Free companion app with iOS 7.0 or later.
11) Product life : 5 years
12) Clinical Test : In accordance with EN1060-4 :2004 & ANSI/AAMI/ISO 81060‐2:2009
Specifications are subject to change without prior notice or any obligation on the parts of the
manufacturer.
Disposal
Actuation of European directives 2002/95/EC, 2002/96/EC and 2003/108/EC, for reduction in
use of dangerous substances in the electric and electronic device and for garbage disposal.
The symbol applied on the device or its packaging means that at the end of its useful life the
product must not be disposed of with domestic waste.
At the end of devices useful life, the user must deliver it to the able collecting centers for
electric and electronic garbage, or give back to the retailer when purchasing a new device. Disposing of
the product separately prevents possible negative consequences for the environment and for health,
deriving from inadequate disposal. It also allows the recovery of materials of which it’s made up in order
to obtain an important saving of energy and resources and to avoid negative effects to the environment
and health. In case of abusive disposal of device by the user, will be applied administrative
endorsements in compliance with current standard. The device and its parts is mared with regard to
disposal, as appropriate, in accordance with national or regional regulations.
Certifications
This device complies with the following normative documents:
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices as amended by Directive 2007/47/EC
EN ISO 13485:2003/AC: 2009:Medical devices - Quality management systems – Requirements for regulatory
purposes (ISO 13485:2003) Reference to standards contd.
EN ISO14971:2012: Medical devices - Application of risk management to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-1:2006+AC (2010) : Medical electrical equipment -
Part 1:General requirements for basic safety and essential Performance
EN1060-3:1997+A1:2005+A2:2009: Non-invasive sphygmomanometers, Part 3: Supplementary requirements for
electromechanical blood pressure measuring systems
EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers.
