Functional test equipment or SpO
2
simulators cannot be used to verify the accuracy of the SpO
2
monitor
and pulse oximeter sensor. The accuracy of the SpO
2
monitor and pulse oximeter sensor needs to be
verified by clinical data.
Functional test equipment or SpO
2
simulators can be used to evaluate the accuracy of PR.
This monitor and its supporting SpO
2
sensor and cable extender have been tested for compliance with
ISO 80601-2-61.
The Monitor is compatible with the SpO
2
sensor specified by Comen only.
Before monitoring the patient please check if the sensor and extension cord are compatible with the
Monitor. Incompatible accessories may reduce the performance of the Monitor.
Before monitoring the patient please check if the sensor cable works properly. Remove the SpO
2
sensor
cable from the sensor interface, and the Monitor will display the prompt message “SpO
2
sensor off” and
trigger the alarm sound.
If the SpO
2
sensor or its package seems damaged do not use it but return it to the manufacturer or your
distributer.
Long-time continuous monitoring may increase the risk of undesired skin characteristic changes
(extremely sensitive, turning red, blistered or pressure necrosis), especially for neonates or the patients
with perfusion disorder or variable or immature skin morphology diagram. Align the sensor with the light
path, fix it properly and check its position regularly based on skin quality changes (change the sensor
position in case of reduced skin quality). Perform such checks more frequently if necessary (subject to the
condition of the patient).
Check the patient’s skin every two hours to ensure good skin quality and lighting. In case of any skin
change, move the sensor to another part. Change the location of the sensor at least every four hours.
Make sure the sensor cable and electrosurgical equipment cable are not intertwined.
Do not place the sensor on a limb with ductus arteriosus or intravenous tubes.
Setting the upper SpO
2
alarm limit to 100% will disable the upper-limit alarm. Premature infants may get
infected with crystalline posterior fibrous tissue diseases in cases of high SpO
2
. Please set the upper SpO
2
alarm limit based on well-established clinical practices.
The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only. The manual,
accessories, directions for use, all precautionary information, and specifications should be read before
use.
Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
Do not place the pulse oximeter or accessories in any position that might cause it to fall on the patient.
Do not start or operate the pulse oximeter unless the setup was verified to be correct.
Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an MRI environment.
Explosion hazard: Do not use the pulse oximeter in the presence of flammable anesthetics or other
flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide.
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