Omron M7 Intelli IT Instruction Manual page 41

6. Specifications
Cuff / Tube material
Contents
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.
• This device has not been validated for use on pregnant patients.
• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This
device is protected against solid foreign objects of 12 mm diameter and greater such as a finger.
• 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.
Nylon, polyester, polyvinyl chloride
Monitor, arm cuff, instruction manual, storage case, battery set, blood pressure
pass, setup instructions
EN
37