Power Requirements; Calibration; Declaration; Detailed Descriptions Of Product Functions - Henry Schein 900-6368 Operator's Manual

Calibration

1. The functional tester cannot be used to assess the accuracy of the Oximeter.
2. Index 2 that made by Bio-Tek company is a function tester. Set Tech to 1, R curve to 2, and then a user can
use this particular calibration curve to measure the Oximeter.
3. The test methods used to establish the SpO2 accuracy is clinical testing. The Oximeter used to measure the
arterial haemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from
arterial blood sampling with a CO-Oximeter.

Declaration

EMC of this product complies with IEC60601-1-2 standard.
The materials which the user can come into contact have no toxicity and no action on tissues comply with
ISO10993-1, ISO10993-5 and ISO10993-10.

Detailed descriptions of product functions

1. Display Type: OLED display
2. SpO : Measurement range: 70-100%
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3. Pulse Rate: Measure range: 30~235 BPM
Pulse Intensity: Bar graph Indicator

4. Power Requirements:

Two AAA alkaline Batteries
Low power indication:
Battery Life:
Two AAA 1.5V, 800mAh alkaline batteries could be continuously operated as long as 30 hours.
Accuracy: 70%-100%, ±3%; 69% no definition.
Accuracy: 30~99bpm, ±2bpm; 100~235bpm, ±2%
Power consumption: Less than 30mA
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