MH3418-01
EN-4
The Quanta Pulse Oximeter and its accessories should be disposed of properly.
Battery Caution:
There is a risk of explosion if the battery for the Quanta Pulse
Oximeter is replaced by an incorrect type.
The Quanta Pulse Oximeter is intended for adult use.
Quanta Pulse Oximeter does not provide with a low SpO2 alarm condition or
pulse rate physiological alarm condition.
Quanta Pulse Oximeter does not support low perfusion detection.
Clean the skin of Quanta Pulse Oximeter sensor and charger with 75% alcohol;
and clean the finger sleeve in wash machine.
If you wear Quanta Pulse Oximeter too long, it may cause uncomfortable by
long time pressure. Please check if you have any on the finger every eight
hours.
Quanta Pulse Oximeter Sensor is a compact all-in-one design with Emitter /
Receiver embedded inside. So that it doesn’t have to verify the compliance of
monitor, probe extenders and cable before use.
Quanta Pulse Oximeter has been validated and tested for compliance with
international standard ISO 80601-2-61.
The self life of Quanta Pulse Oximeter is 2 years.
Quanta Pulse Oximeter is calibrated to display functional oxygen saturation.
The pulse rate accuracy is verified by the root-mean-square(rms) method which
is the difference between pulse rate data recorded by Quanta Pulse Oximeter
and with pulse rate data set by the SpO2 simulator.
Do not use any unauthorized oximeter simulator to assess the accuracy of
Quanta Pulse Oximeter. And if there has any question please contact Quanta
Customer Support.
The SpO2 accuracy validation, Quanta Pulse oximeter clinical trial was
performed in accordance with ISO 80601-2-61 and FDA guidance. The study
population is healthy volunteers who consent to induced hypoxia and arterial
blood sampling more than 200 data points. Participated subjects is including
Asian, Caucasian, African, Male, and Female. Their ages are from 21 to 50
years old. The statistically study result indicated that the SpO2 accuracy (
±
Arms)
of Quanta Pulse Oximeter was less than
±
3 % in the SpO2 range 70% ~100%
complied with the accuracy requirement.
When the finger sleeve is not viscous, or it is recommended to use finger sleeve
for a month if it’s used every day.
