Bedienungsanleitung Omron M3 Comfort - HEM-7155-E (Seite 10 von 18) (Englisch)

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Note

• These specifications are subject to change without notice.

• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013. In the clinical validation study, K5 was used on

85subjects for determination of diastolic blood pressure.

• This device has been validated for use on pregnant and pre-eclampsia patients according to the Modified European Society of Hypertension

Protocol*.

• This device has been validated for use on diabetic (Type II) population**.

• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This monitor 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 is protected against vertically

falling water drops which may cause issues during a normal operation.

* Topouchian J et al. Vascular Health and Risk Management 2018:14 189–197

** Chahine M.N. et al. Medical Devices: Evidence and Research 2018:11 11–20

7. Correct Disposal of This Product (Waste Electrical & Electronic Equipment)

This marking shown on the product or its literature, indicates that it should not be disposed of, with other household wastes at the

end of its working life.

To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this product from

other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources.

Household users should contact either the retailer where they purchased this product, or their local government office, for details of

where and how they can return this item for environmentally safe recycling.

Business users should contact their supplier and check the terms and conditions of the purchase contract. This product should not be mixed with

other commercial waste for disposal.

8. Important Information Regarding Electromagnetic Compatibility (EMC)

HEM-7155-E and HEM-7155-EO conform to EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard.

Further documentation in accordance with this EMC standard is available at

www.omron-healthcare.com

Refer to the EMC information for HEM-7155-E and HEM-7155-EO on the website.

9. Guidance and Manufacturer’s Declaration

• This blood pressure monitor 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 product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan. The Core component for OMRON

blood pressure monitors, which is the Pressure Sensor, is produced in Japan.

• Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident

that has occurred in relation to this device.

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