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clinical institutions and home environments.
2.2
Brief Device Description
The A310L Pulse Oximeter, is based on digital technology. The device is intended for non-invasive spot-check measurement
of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm
[4]
can minimize the influence of
motion artifact and improve measurement accuracy of low perfusion
[5]
.
The A310 Series Pulse Oximeter can be used to measure human SpO2 and pulse rate through the finger. The product is
suitable for private home-use, hospitals (including clinical use in internist/surgery, anesthesia, pediatrics etc.), social medical
organizations, physical care in sports etc.
Note: [4] DSP algorithm: Digital signal processor algorithm.
[5] Low Perfusion: In physiology, perfusion is the process of a body delivering blood to a capillary bed in its biological tissue.
Under the condition of low perfusion, the measurement of non-invasive saturation of pulse-blood oxygen is not accurate.
2.3
Product Features
Lightweight for easy carrying and use.
Manually adjust the direction of interface.
Color LED display, simultaneous display for testing value and plethysmography [6].
Visual & Sound reminder function. Real-time spot-checks.
Low Battery voltage indicator.
Automatic switch-off.
Includes two standard AAA 1.5V alkaline batteries.
Note:[6] Plethysmograph: is an instrument for measuring changes in volume within an organ or whole body (usually resulting from
fluctuations in the amount of blood or air it contains).
CAUTION
: The device must not be used on children below 3 years of age, as it cannot be guaranteed to provide accurate results.
CAUTION
: The Pulse Oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with
other methods of assessing clinical signs and symptoms.
CAUTION
: A function tester cannot be used to assess the accuracy of the Pulse Oximeter monitor or sensor.
Clinical testing is used to establish the SpO2 accuracy. The measured arterial SpO2 value (SpO2) of the sensor is
compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter.
The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 70-100%.
Accuracy data is calculated using the root-mean-square (Arms value) for all subjects. Only about two-thirds of PULSE
OXIMETER EQUIPMENT measurements can be expected to fall within ±Arms of the value measured by a
CO-oximeter.
A pulse simulator shall be used to assess pulse rate accuracy. The measured pulse rate is compared to the preset pulse rate
value in the simulator. Accuracy data is calculated using the root-mean-square (Arms value) for all subjects.
2.4
Expected Service Life
Is dependent on:
The expected service life of the ME equipment;
The expected service life of parts or accessories shipped with the ME equipment;
Where the shelf life is less than the expected service life, the shelf life of parts or accessories shipped with the ME
equipment.
2.5
Operation
2.5.1
Installing batteries
Place two AAA batteries into the battery compartment taking care to align the
polarities, then close the cover.
WARNING
: Do not attempt to recharge normal alkaline batteries, as they may leak and may cause a fire or even
explode.
