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WARNING! Tissue damage may result from overexposure to sensor light during
photodynamic therapy with agents such as verteporphin, porfimer sodium,
and metatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at least
every hour and observe for signs of tissue damage. More frequent sensor site
changes/inspections may be indicated depending upon the photodynamic
agent used, agent dose, skin condition, total exposure time or other factors.
Use multiple sensor sites.
WARNING! When connecting this monitor to any instrument, verify proper operation
before clinical use. Refer to the instrument's user manual for full instructions.
Accessory equipment connected to the monitor's data interface must be
certified according to the respective IEC standards, i.e., IEC 950 for data
processing equipment or IEC 601-1 for electromedical equipment. All
combinations of equipment must be in compliance with IEC 601-1-1 systems
requirements. Anyone connecting additional equipment to the signal input
port or the signal output port configures a medical system, and, therefore,
is responsible that the system complies with the requirements of the system
standard IEC 601-1-1.
WARNING! IEC 950 approved equipment must be placed outside the "patient
environment". The patient environment is defined as an area 1.5 m (4.92 feet)
from the patient.
WARNING! Verify that all LEDs (light emitting diodes) on the display light up upon startup
of the device.
WARNING! Remove device batteries prior to long term storage.
WARNING! Under certain clinical conditions, pulse oximeters may display dashes if unable
to display SpO
oximeters may also display erroneous values. These conditions include, but are
not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low
pulse rates or a combination of the above conditions. Failure of the clinician to
recognize the effects of these conditions on pulse oximeter readings may result
in patient injury.
Pulse Oximeter for Sleep Screening Operation Manual
PATIENT ENVIRONMENT
and/or pulse rate values. Under these conditions, pulse
2
Chapter 1: Introduction
1-3
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