2
skin, inspect the sensor site more frequently.
Ÿ
Functional tester cannot be used to assess the accuracy of a SpO
2
sensor or a device.
Ÿ
This device is designed to determine the arterial oxygen saturation
percentage of functional hemoglobin. Factors that may degrade pulse
oximeter performance or affect the accuracy of the measurement include
the following:
- excess ambient light
- excessive motion
- electrosurgical interference
- blood flow restrictors
(arterial catheters, blood pressure cuffs, infusion lines, etc.)
- moisture in the sensor
- improperly applied sensor
- incorrect sensor type
- poor pulse quality
- venous pulsations
- anemia or low hemoglobin -concentrations
- cardiogreen and other -intravascular dyes
- carboxyhemoglobin
- methemoglobin
- dysfunctional hemoglobin
1.2
Guide to Symbols
Symbol
Description
Type BF-Applied Part
Manufacturer
European authorized representative
CE0197
CE Marking indicating conformance to EC directive
No. 93/42/EEC concerning medical devices.
MRI unsafe. Presents hazards in all MR
environments as device contains strongly
ferromagnetic materials.
Indicate separate collection for electrical and
electronic equipment (WEEE).
