11. The device complies with electromagnetic compatibility requirements
for electronic medical products or systems in IEC60601-1-2. Radio
transmission equipment or other electromagnetic interference may affect
the performance of this device.
12. Portable radio communication equipment may affect the performance
of this device.
13. The device should not be used in the vicinity of other radio equipment
or stacked on any other equipment.
14. Use of the device is not recommended during transportation of
patients, such as in ambulances or other vehicles.
15. Do not disassemble,or attempt repair of this device without prior
authorization.
16. The materials that will come into contact with the patient is a medical
silica gel pad that conforms to ISO 10993.
17.Temperature shall not exceed 40℃ when in contact with patient. The
recommended maximum application time should not exceed 2 hours.
18. The device is not intended for patients weighing less than
20kg,Pregnant women and nursing Mothers.
19.Please comply with local authority regulations when disposing of
batteries. Never dispose of batteries in fire!
20.This device has no audible alarms.
21.The device is ready for its intended use when the ambient temperature
is 40℃ ,The time required to reach ambient temperature from the
minimum/maximum storage temperature is 15±5mins.
4.2 Causes of Incorrect Measurements
1. Dysfunction of important indicators of hemoglobin (such as carbon-
containing hemochrome or methemoglobin);
2. Excessive intravascular staining agent (such as indocyanine green or
methylene blue);
3. Impact of surrounding light; add a protective housing to the sensor if
necessary;
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4. Excessive patient movement may be erroneously identified as pulse
signals and may affect the measurements of this device.
5. Venous rhythmic beating;
6. Placement of the sensor and blood pressure cuff at the same artery or
blood vessel.
7. Excessively low blood pressure, systolic blood pressure, severe anemia
or hypothermia;
8. Cardiac arrest or shock;
9. Excessively smooth nails or false nails;
10. Weak pulse or weak perfusion;
11. Low hemoglobin;
12. Excessively long nails or nail polish and other cosmetics on nails.
13. Blood oxygen waveform is not normalized; when the signal is too
weak, waveform amplitude decreases; excessively low waveform
amplitude may lead to inaccurate measurement results;
5. Symbol Description
Symbol
Type BF applied part
%SpO
Pulse oxygen saturation
2
PI%
Perfusion index
PR
Pulse Rate
Battery power indication
Attention
Description
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