Guidance And Manufacturer's Declaration - Omron WheezeScan HWZ-1000T-E Manual De Instrucciones

9. Guidance and Manufacturer's Declaration

• Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipment type
HWZ-1000T-E is in compliance with Directive 2014/53/EU.
• The full text of the EU declaration of conformity is available at the following internet
address: www.omron-healthcare.com
• This OMRON product is produced under the strict quality system of OMRON
HEALTHCARE Co., Ltd., 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.
Symbols Description
Applied part - Type BF Degree of
protection against electric shock
(leakage current)
CE Marking
Medical device
Humidity limitation
Necessity for the user to consult this
instruction manual
Date of manufacture
To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation, or to
indicate equipment or systems e.g. in the medical electrical area that include RF transmitters
or that intentionally apply RF electromagnetic energy for diagnosis or treatment.
Ingress protection degree provided
IP XX
by IEC 60529
Serial number
Temperature limitation
Atmospheric pressure limitation
Power on / off
The direction of correct polarity of
the battery
EN
EN22