Seca mVSA 535 Instructions For Use Manual page 70

70 • /
seca mVSA 535 seca mBCA 525
CAUTION!
Patient hazard, incorrect measurement
► Do not use damaged sensors or damaged patient cables, for
example with exposed optics.
► Do not place the pulse oximeter where the controls can be changed
by the patient.
► Electrical shock and flammability hazard: Before cleaning, always
turn off the device and disconnect from any power source.
► When patients are undergoing photodynamic therapy they may be
sensitive to light sources. Pulse oximetry may be used only under
careful clinical supervision for short time periods to minimize inter-
ference with photodynamic therapy.
► Do not place the pulse oximeter on electrical equipment that may af-
fect the device, preventing it from working properly.
► If SpO
values indicate hypoxemia, a laboratory blood sample
2
should be taken to confirm the patient's condition.
► If the Low Perfusion or Low Signal Qualitiy message is frequently
displayed, find a better perfused monitoring site. In the interim, as-
sess the patient and, if indicated, verify oxygenation status through
other means.
► Change the application site or replace the sensor and/or patient ca-
ble when a "Replace sensor" and/or "Replace patient cable", or a
persistent poor signal quality message (such as "Low SIQ") is dis-
played on the host monitor. These messages may indicate that pa-
tient monitoring time is exhausted on the patient cable or sensor.
► If using pulse oximetry during full body irradiation, keep the sensor
out of the radiation field. If the sensor is exposed to the radiation, the
reading might be inaccurate or the device might read zero for the
duration of the active irradiation period.
► Variation in measurements may be profound and may be affected
by sampling technique as well as the patient's physiological condi-
tions. Any results exhibiting inconsistency with the patient's clinical
status should be repeated and/or supplemented with additional test
data. Blood samples should be analyzed by laboratory instruments
prior to clinical decision making to completely understand the pa-
tient's condition.
► Do not submerge the pulse oximeter in any cleaning solution or at-
tempt to sterilize by autoclave, irradiation, steam, gas, ethylene ox-
ide or any other method. This will seriously damage the pulse
oximeter.
► Electrical Shock Hazard: Carry out periodic tests to verify that leak-
age currents of patient-applied circuits and the system are within
acceptable limits as specified by the applicable safety standards.
The summation of leakage currents must be checked and in com-
pliance with IEC 60601-1 and UL60601-1. The system leakage cur-
rent must be checked when connecting external equipment to the
system. When an event such as a component drop of approximately
1 meter or greater or a spillage of blood or other liquids occurs, re-
test before further use. Injury to personnel could occur.
► To minimize radio interference, other electrical equipment that emits
radio frequency transmissions should not be in close proximity to
the pulse oximeter.
► Replace the cable or sensor when a replace sensor or when a low
SIQ message is consistently displayed while monitoring consecutive
patients after completing troubleshooting steps listed in this manual.
NOTE:
• A functional tester cannot be used to assess the accuracy of the
pulse oximeter.