Guidance And Manufacturer's Declaration - Omron M6 Comfort Manual De Instrucciones

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-7360-E/EO conforms to the EN60601-1-2:2015 Electromagnetic
Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
OMRON HEALTHCARE EUROPE at the address mentioned in this instruction
manual or at: www.omron-healthcare.com.

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.
EN7
• 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.
10. How to Calculate Weekly Averages
Morning Weekly Average Calculation
This is the average for the measurements taken during the morning (4:00 - 9:59)
between Sunday and Saturday. The 2 or 3 readings taken within the first
10 minute timeframe in the morning between 4:00 - 9:59 will be used to
calculate the morning average for each day.
Evening Weekly Average Calculation
This is the average for the measurements taken during the evening (19:00 - 1:59)
between Sunday and Saturday. The 2 or 3 readings taken within the last
10 minute timeframe in the evening between 19:00 - 1:59 will be used to
calculate the evening average for each day.
Within 10 min.
Measurements
in the morning
Within 10 min.
Measurements
in the morning