Latex Content Statement; Section1-Overview; Intended Use; Essential Performance - MedLinket AM-806 Manual De Instrucciones

Latex Content Statement

The PULSE OXIMETER is not made with natural rubber latex in any location that may
result in users contact.

Intended Use

This pulse oximeter is not a medical device and is not intended to diagnose and/or
treat any medical condition or disease. It is intended for non-medical use by healthy
people to monitor their pulse rate and blood oxygen levels. It is for sports and/or
aviation use.
Target population: Adult, adolescent and child.

Essential Performance

The essential performance of this device is defined as SpO2 accuracy and pulse rate
accuracy, or an indication of abnormal operation. Accuracies may be affected as a
result of exposure to electromagnetic disturbances that are outside of the
environments listed in this Instruction For Use. If such a kind of situation appears,
move the device away from the source of electromagnetic disturbances. When
there's signal inadequacy, the symbol of "?" will be displayed on the screen, indicating
the displayed SpO2 or pulse rate value is potentially incorrect.

About the Pulse Oximeter

The device contains a dual light source (red LED and infrared red LED) and a photo
detector. Bone, tissue, pigmentation and venous vessels normally absorb a constant
amount of light over time. The arteriolar bed normally pulsates and absorbs variable
amounts of light during the pulsations. The ratio of light absorbed is translated in an
oxygen saturation measurement (SpO2). Because a measurement of SpO2 is
dependent on light from the device, excessive ambient light can interfere with this
measurement.
Section 1- Overview
English 4