xiii
Electromagnetic Compatibility (for Europe)
This equipment complies with EN 60601-1-2 (2015), safety standard regarding the electromagnetic
disturbances of medical electrical equipment. To ensure maximum performance against the
electromagnetic disturbances, make sure to follow the precautions for installation and usage described
in this manual.
●
This equipment is intended for use in the medical facility (except inside the shield room of MRI device),
and satisfies the immunity level for professional healthcare facility environment stipulated in
EN 60601-1-2.
●
An excessive magnetic disturbance may degrade the HR measurement accuracy (refer to
2. Specification, ECG, HR measurement detection), which is the essential performance of this equipment,
and may cause delay in treatment or inaccurate diagnosis.
●
When using this equipment, interference with other medical electrical equipments or non-medical
electrical equipments may oocur. Make sure that no interference is present before usage.
●
To ensure basic safety and essential performance related to electromagnetic distrubances during the
expected service life of this equipment, “Daily Check” and “Periodic Check” must be performed.
(refer to 7. Maintenance and Inspection)
Precautions for Safe Operation under Electromagnetic Influence
CAUTION
If any sorts of electromagnetic wave, magnetic field, or static electricity exist around the
equipment, noise interference or malfunction of the equipment may occur. If any unintended
malfunction or noise occurs during monitoring, check the magnetic influence and take
appropriate countermeasures.
The followings are examples of the common cause and countermeasures.
●
Mobile Phone
The radio wave may cause malfunction to the equipment.
Mobile phones and radio sets should be turned off in the room (building) where medical device is
located.
●
Static Electricity
In a dry environment (room), static electricity is likely to occur. Take the following countermeasures.
Both operator and patient should remove any static electricity before entering the room.
Humidify the room.
CAUTION
If this equipment is installed close to, or stacked with other equipment, malfunction may
occur. Make sure to verify that the equipments operate properly in a used location.
Use of accessories, probes, or cables other than specified may cause increase in
electromagnetic emission or decrease in electromagnetic immunity resulting in malfunction of
the equipment.
The portable RF communications equipment (including antenna cable and peripheral
equipment such as external antenna) with the specified cable should be used in a location at
least 30 cm apart from any part of this equipment. Otherwise, it may result in performance
degradation of this equipment.
