Omron HEM-7380T1-EBK - Correct Disposal of this Product (Waste Electrical & Electronic Equipment); Guidance and Manufacturers Declaration

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R This monitor is clinically investigated according to the requirements
of ENISO81060-2:2014 and complies with ENISO81060-2:2014 and
ENISO81060-2:2019 + A1:2020 (excluding pregnant and pre-eclampsia
patients). In the clinical validation study, K5 was used on 85subjects for
determination of diastolic blood pressure.
R This device has been validated for use on pregnant and pre-eclampsia
patients according to the Modified European Society of Hypertension
Protocol*.
R This device has been validated for use on diabetic (Type II) population**.
R 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 monitor and optional ACadapter HHP-CM01 are protected
against vertically falling water drops which may cause issues during a normal
operation. The optional ACadapter HHP-BFH01 is protected against oblique
falling water drops which may cause issues during a normal operation.
R Operation mode classification complies with IEC60601-1.
R Communication with a smart device is paired and encrypted according to
Bluetooth Low Energy specifications. Pairing requires user interaction.
* 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
About a wireless communication interference
The Bluetooth option in the product is used to connect to dedicated apps
on mobile devices to synchronize date/time data from mobile device to the
product, and to synchronize measurement data from the product to mobile
device. Further handling of the data on the mobile device is up to the user’s
discretion. This produc t operates in an unlicensed ISM band at 2.4GHz where
any third party can intercept the radio waves, willfully or accidentally, for any
unknown purpose. In the event this product is used near other wireless devices
such as microwave and wireless LAN, which operate on the same frequency
band as this product, there is a possibility that interference may occur. If
interference occurs, stop the operation of the other devi
ces or relocate this
product away from other wireless devices before attempting to use it.
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 f
or disposal.
8. Important Information regarding
Electromagnetic Compatibility (EMC)
HEM-7380T1-EBK conforms to the EN60601-1-2 Electromagnetic Compatibility
(EMC) standard.
Further documentation in accordance with this EMC standard is available at:
https://healthcare.omron.com/electro-magnetic-compatibility.
Refer to the EMC information for HEM-7380T1-EBK on the website.
9. Guidance and Manufacturer’s Declaration
R Hereby, OMRONHEALTHCARECo.,Ltd., declares that the radio equipments
type HEM-7380T1-EBK is in compliance with Directive 2014/53/EU.
R The full text of the EU declaration of conformity is available at the following
internet address: www.omron-healthcare.com
R 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.
The AFib algorithm was developed using several databases published by
PhysioNet that are available under the ODCAttributionLicense.
For more information, please visit the product page:
www.omron-healthcare.com
R Please report to the manufacturer and the competent authority of the
Member State in which you are established ab
out any serious incident that
has occurred in relation to this device.
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