American Diagnostic Corporation (ADC) Diagnostix 2100 - Manual (Page 2)

ADC® Fingertip Pulse Oximeter
Thank you for purchasing an ADC Diagnostix TM Brand Fingertip Pulse Oximeter. We’re proud of the care
and quality that goes into the manufacture of every product that bears our name. With proper care and
maintenance your Diagnostix TM Fingertip Pulse Oximeter will provide many years of dependable service.
Device Description and Intended Use
This device is intended for medical diagnostic purposes only. It is used to indirectly measure the func-
tional oxygen saturation (SpO2) of an adult or pediatric patient’s blood. It is intended for use on fingers
with a thickness of 8mm-20mm (.31”-.79”). This is the distance between the fingernail (top), and the
finger pad (bottom). Functional oxygen saturation refers to the ratio of oxyhemoglobin to all hemoglobin
that is capable of carrying oxygen. This oximeter is not intended for continuous monitoring. The Pulse
Oximeter requires no routine calibration or maintenance other than replacement of batteries.
Pulse oximetry combines the principles of optical plethysmography and spectrophotometry to
determine arterial oxygen saturation values. Optical plethysmography uses light absorbance technol-
ogy to reproduce waveforms produced by pulsating blood. Spectrophotometry uses various wave-
lengths of light to perform quantitative measurements about light absorption. Photoelectric
Oxyhemoglobin Inspection Technology is combined with Capacity Pulse Scanning and Recording
Technology, so that two beams of different wavelengths of light (660nm glow and 940nm near in-
frared light) can be focused onto the human nail tip through a finger-tip sensor. These two LED’s are
chosen because the light absorption varies with the oxygen concentration of hemoglobin in these fre-
quencies. The pulse amplitudes of the red and near infrared signals are detected using photoelectric
sensors and run through a microprocessor which converts the readings to numerical values.
Contraindications:
The patient suffers from significant levels of dysfunctional hemoglobins (such as carbonxy- •
hemoglobin or methemoglobin).
Intravascular dyes such as indocyanine green or methylene blue have been injected into the •
patient.
Used in the presence of high ambient light (ie, direct sunlight). Shield the sensor area with a •
surgical towel if necessary.
There is excessive patient movement. •
The patient experiences venous pulsations. •
The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. •
The patient is in cardiac arrest or is in shock. •
Patients have fingernail polish or false fingernails as they may cause inaccurate SpO2 readings. •
General Warnings
A warning statement in this manual identifies a condition or practice which, if not corrected or dis-
continued immediately, could lead to patient injury, illness, or death.
WARNING: Before use, carefully read the manual.
WARNING: Do not use the pulse oximeter in an MRI or CT environment.
WARNING: The operation of Pulse Oximeter may be affected by the use of an electrosurgical unit (ESU).
WARNING: Federal law restricts this device to sale by or on the order of a physician or licensed
healthcare practitioner.
WARNING: 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.
WARNING: Follow local ordinances and recycling instructions regarding disposal or recycling of