Operator's Manual

Chapter 6 Taking medical readings
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 94
CAUTION

Variation in haemoglobin measurements may be profound and may be affected by
sampling technique as well as the patient's physiological conditions. Any results
exhibiting inconsistency with the patient’s clinical status should be repeated and/or
supplemented with additional test data. Blood samples should be analysed by
laboratory devices prior to clinical decision making to completely understand the
patient’s condition.
 Do not submerge the pulse co-oximeter in any cleaning solution or attempt to sterilize
by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will
seriously damage the pulse co-oximeter.
 Electrical Shock Hazard: Carry out periodic tests to verify that leakage 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 compliance with IEC 60601-1 and UL60601-1. The system leakage current 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, retest before further use. Injury to personnel could occur.
 Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
 To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse co-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 co-oximeter.
 High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor,
may not allow the pulse co-oximeter to obtain vital sign readings.
 When using the Maximum Sensitivity setting, performance of the "Sensor Off"
detection may be compromised. If the device is in this setting and the sensor becomes
dislodged from the patient, the potential for false readings may occur due to
environmental "noise" such as light, vibration, and excessive air movement.
 Do not loop the patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
 Additional information specific to the Masimo sensors compatible with the pulse
oximeter, including information about parameter/measurement performance during
motion and low perfusion, may be found in the sensor's directions for use (DFU).
 Cables and sensors are provided with X-Cal™ technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or
Sensor DFU for the specified duration of the patient monitoring time.