Product Manual

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ADC

Fingertip Pulse Oximeter

Thank you for purchasing an ADC Diagnostix

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

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 functional oxygen saturation (SpO2) of an adult or pediatric patient’s

blood. It is intended for use on fingers with a thickness of .3” to .8” (6.6mm to

19.7mm). 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 spectropho-

tometry to determine 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 measure-

ments 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 infrared light) can be

focused onto the human nail tip through a finger-tip sensor. These two LED’s are cho-

sen 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 de-

tected 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 discontinued 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 the device and device components, including batteries.

CAUTION: Do not use the pulse oximeter in an explosive atmosphere.

CAUTION: SpO2 and pulse rate data is displayed for informational purposes only

and does not constitute a diagnosis or medical advice of any kind. Only a

qualified healthcare professional should interpret the data obtained on this device.

CAUTION: Check the pulse oximeter sensor application site frequently to

determine the positioning of the sensor and circulation and skin sensitivity of

the patient.

CAUTION: The pulse oximeter is not for continuous monitoring.

CAUTION: Prolonged use or the patient's condition may require changing the

sensor site periodically. Change sensor site and check skin integrity, circulatory

status, and correct alignment at least every 4 hours.

CAUTION: Inaccurate measurements may be caused by autoclaving, ethylene

oxide sterilizing, or immersing the sensors in liquid.

CAUTION: The device should not be used on an extremity with a blood pressure

cuff, arterial catheter, or intravascular line.

Brief Description of Front Panel

Included Pulse Oximeter Accessories

• One (1) lanyard

• Two (2) AAA batteries

• One (1) user manual

Battery Installation

1. Remove battery compartment cover

by depressing button on battery

cover top, then slide cover in the

direction of the arrow, then tilt

upward on hinge.

2. Insert two AAA batteries into battery

compartment being sure to

observe the correct polarities.

3. Replace the battery cover by

reversing step 1. (Figure 1)

Note: Be sure to observe correct battery polarity. Failure to do so might

damage the device. If device will not be used for an extended period of time,

remove batteries. Replace batteries when low battery symbol appears on

display. Always replace BOTH batteries at the same time

Operating Instructions

1. Be sure to insert two AAA batteries before attempting to operate.

2. Clean inside surface of oximeter and patient’s finger with isopropyl alcohol

before use.

3. Squeeze the end opposite the power switch between the thumb and forefinger

in order to open the device (there is a textured surface on the battery cover

side to facilitate grip) (Figure 2)

4. Insert patient’s finger, nail side up into the device. (be sure to fully insert the

patient’s finger so that the sensors are completely covered by the finger.) Index

or middle finger is recommended.

5. Release the device allowing it to clamp down on the patient’s finger.

6. Press the power switch on the front (top) panel to activate.

7. Have patient keep still for optimal accuracy

8. Depending upon environmental and patient conditions, the device will begin

to display readings in about 4 seconds.

9. Note readings on the display.

10. Remove the patient’s finger from the device by squeezing between forefinger

and thumb as indicated in Figure 2.

11. The display will indicate finger out.

12. The unit will power off approximately 10 seconds after the patient’s finger is

removed from the device.

Changing Oximeter Display Mode

There are six different display modes. The display modes alter the orientation of the

display to facilitate reading by the observer. Horizontal modes display the pulse wave

form along with SPO2 and pulse rate while vertical modes display a pulse rate bar

graph along with the SPO2 and pulse rate readings.

To alter the display mode:

1. After the unit is powered on each brief press of the power switch will cycle

through to the next display mode in the sequence shown.

Note: the default setting is display mode 1.

Display Mode Cycle

Alarm

On models equipped with an alarm, the alarm condition will appear when:

SPO2 < 90% / PR <60 or >100bpm

If the unit is in display mode 1 (silent mode), the parameter (SPO or PR) flashes and

an audible beep is heard if it exceeds the alarm condition. If the unit is in display

modes 2-6 (audible mode), the unit will signal an alarm condition with both visual and

audible alerts.

To silence the alarm tone for 30 seconds press the power button twice during the

condition.

Changing the Display Brightness (10 adjustable brightness settings)

To change the brightness setting:

1. After the unit is powered on, hold and depress the power switch. It will cycle

through from BR4 up to BR10, then start back at BR1.

Note: The default setting is level 4 (BR4).

Lanyard Attachment

1. Thread thinner end of the lanyard through the hanging hole at the rear end of

the device.

2. Thread thicker end of the lanyard through the threaded end before pulling

it tightly.

Care and Maintenance

1. Replace the batteries promptly when low voltage indicator appears.

2. Clean surface of the fingertip and oximeter with isopropyl alcohol before it

is used in diagnosis for patients.

3. Remove the batteries if unit will not be operated for extended period of time.

4. It is best to store this product in a place where ambient temperature is

-10°C -40°C(14°F -104°F) and humidity is 10%-80%.

5. It is recommended that the product should be kept in a dry environment at

all times.

6. Please follow local ordinances when disposing of batteries.

Cleaning the Pulse Oximeter

Clean the rubber touching the finger inside of the Oximeter with a soft dampened cloth

with 70% isopropyl alcohol, and clean the test finger using alcohol before and after

each test.

Note: Do not pour or spray any liquids onto the Oximeter, and do not allow any

liquids to enter any openings in the device. Allow the Oximeter to dry thoroughly

before reusing.

SpO

Pulse Rate Signal

Intensity Bar Graph

Pulse Rate

Power Switch

Low Power

Indicator

SpO

Waveform

(Figure 2)

Handstand Horizontal

(4th click)

Normal Vertical

(5th click)

Handstand Vertical

(6th click)

Normal Horizontal

Wave Display

(Default Setting)

Normal Horizontal

Wire Display

(2nd click)

Normal Horizontal

(3rd click)

(Figure 1)