Mindray BeneHeart D6 - Monitoring Spo; Spo2 Safety Information

13 - 1
13 Monitoring SpO
2
13.1 SpO2 Safety Information
WARNING
• When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a
laboratory co-oximeter to completely understand the patient’s condition.
• Do not use SpO
2
sensors during magnetic resonance imaging (MRI). Induced current could
potentially cause burns.
• Prolonged continuous monitoring may increase the risk of undesirable changes in skin
characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two
hours and move the sensor if the skin quality changes. Change the application site every four hours.
For neonates or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor
site more frequently.
• If the sensor is too tight because the application site is too large or becomes too large due to edema,
excessive pressure for prolonged periods may result in venous congestion distal from the
application site, leading to interstitial edema and tissue ischemia.
• 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
interference with photodynamic therapy.
• Setting alarm limits to extreme values may cause the alarm system to become ineffective. For
example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a
consideration, do not set the high alarm limit to 100%, which is equivalent to switching off the
alarm.
• SpO
2
is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin
(COHb) and methemoglobin (MetHb).
• To protect from electric shock, always remove the sensor and completely disconnect the pulse
oximeter before bathing the patient.
• The pulse oximeter is not an apnea monitor.
• The pulse oximeter should not be used for arrhythmia analysis.
CAUTION
• Change the application site or replace the sensor and/or patient cable when a persistent SpO2 Low
Signal Quality message is displayed on the equipment. These messages may indicate that patient
monitoring time is exhausted on the patient cable or sensor.
• Replace the cable or sensor when a “SpO2 Sensor Off”, “SpO2 No Sensor”, or “SpO2 Low Signal
Quality” message is consistently displayed while monitoring consecutive patients after completing
troubleshooting steps listed in this manual.
• Variation in 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 analyzed by laboratory instruments prior to clinical decision making to completely
understand the patient’s condition.
• Use only SpO
2
sensors specified in this manual. Follow the SpO
2
sensor’s instructions for use and
adhere to all warnings and cautions.
• Do not place the pulse oximeter where the controls can be changed by the patient.
• 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.