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American Diagnostic Corporation (ADC) Adimals 2150 User Manual

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ADC® Fingertip Pediatric Pulse Oximeter

Thank you for purchasing an ADC Diagnostix™ Brand Fingertip Pediatric 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™ Fingertip Pediatric 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 a pediatric patient’s blood. It is intended for use on fingers with a thick-

ness of 7.64mm - 11.19mm (.3” to .44”). 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 Oxime-

ter requires no routine calibration or maintenance other than replacement of batteries.

Pulse oximetry combines the principles of optical plethysmography and spectrophotometry to deter-

mine arterial oxygen saturation values. Optical plethysmography uses light absorbance technology to

reproduce waveforms produced by pulsating blood. Spectrophotometry uses various wavelengths of

light to perform quantitative measurements about light absorption. Photoelectric Oxyhemoglobin In-

spection Technology is combined with Capacity Pulse Scanning and Recording Technology, so that

two beams of different wavelengths of light (660nm glow and 940nm near infrared light) can be fo-

cused 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 frequencies. 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-he-

moglobin 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 discon-

tinued 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.