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37
6. Specifications
EN
Notes:
• These specifications are subject to change without notice.
• In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood pressure.
• This device is clinically investigated according to the requirements of ISO 81060-2:2013 (excluding pregnant
and pre-eclampsia patients).
• This device has been validated for use on pregnant and pre-eclampsia patients according to the Modified
European Society of Hypertension Protocol*.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This device and
optional AC adapter are protected against solid foreign objects of 12.5 mm diameter and greater such as a
finger. The optional AC adapter (HHP-CM01) is protected against vertically falling water drops which may cause
issues during a normal operation. Another optional AC adapter (HHP-BFH01) is protected against oblique
falling water drops which may cause issues during a normal operation.
• This device fulfils the provisions of EC directive 93/42/EEC (Medical Device Directive).
• This device is designed according to the European Standard EN1060, Non-invasive
sphygmomanometers Part 1: General Requirements and Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems.
• This OMRON device is produced under the strict quality system of OMRON
HEALTHCARE Co., Ltd., Japan. The core component for OMRON devices, which is the
Pressure Sensor, is produced in Japan.
Weight
Monitor: Approx. 390g without batteries
Arm cuff: Approx. 163g
Dimensions
Monitor: Approx. 124 (w) mm
×
90 (h) mm
×
161 (l) mm
Arm cuff: Approx. 145 mm
×
532 mm (air tube: 750 mm)
Cuff circumference
22 to 42 cm
Cuff / Tube material
Nylon, polyester, polyvinyl chloride
Contents
Monitor, arm cuff, instruction manual, storage case, battery set, blood pressure diary, setup
instructions
* Prof. Roland Asmar et al.
publication pending
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