User's Manual

Page 7
About warnings and cautions
Warning and caution statements can appear on the monitor, on the packaging, on the
shipping container, or in this document.
The monitor is safe for patients and clinicians when used in accordance with the instructions
and with the warning and caution statements presented in this manual.
Before using the monitor, familiarize yourself with the sections of this direction for use that
pertains to your use of the monitor.
l Failure to understand and observe any warning statement in this manual could lead to
patient injury, illness, or death.
l Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.
General warnings and cautions
WARNING Many environmental variables, including patient physiology
and clinical application, can affect the accuracy and performance of the
monitor. The clinician must verify all vital signs information before treating
the patient. If there is any question about the accuracy of measurements,
verify the measurement using another clinically accepted method.
WARNING Alarm limits are patient- or facility-specific. The clinician must
set or verify alarm limits appropriate for each patient. Each time the
monitor is powered on, you must check that the alarm settings are
appropriate for your patient before you start monitoring.
WARNING The monitor is not intended for use during patient transport
outside of the medical facility. Do not use the monitor to take
measurements on any patient in transit.
WARNING Use only Fukuda Denshi approved accessories. Using
unapproved accessories with the monitor can affect patient and operator
safety and adversely affect product performance and accuracy. To ensure
patient safety and optimal product performance, use only Fukuda Denshi
recommended accessories and supplies (i.e., cuffs, horses, thermometer,
SpO2 sensors, etc.) and use according to the accessory manufacturer’s
direction for use.
WARNING Inaccurate measurement risk. Do not connect more than one
patient to a monitor.
WARNING Inaccurate measurement risk. Dust and particle ingress can
affect the accuracy of blood pressure measurement. Use the monitor in
clean environments to ensure measurement accuracy. If you notice dust or
lint build-up on the monitor’s vent openings, have the monitor inspected