ADC Diagnostix 2100 Manual

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ADC®Diagnos ixTM 2100
Finger ip Pulse Oxime er
Directions
for Use

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ADC®Fingertip Pulse Oximeter
Thank you for purchasing an ADC DiagnostixTM 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 DiagnostixTM Fingertip Pulse
Oximeter will provide many years of dependable service.
Device Description and Intended Use
This device is intended for medical diagnostic purposes only. t is used to indirectly
measure the functional oxygen saturation (SpO2) of an adult or pediatric patient’s
blood. t is intended for use on fingers with a thickness of 8mm to 20mm (.31” to .79”).
This is the distance between the fingernail (top), and the finger pad (bottom). Func-
tional 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 replace-
ment 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 nspection 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 de-
tected using photoelectric sensors and run through a microprocessor which converts
the readings to numerical values.

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Contraindications:
• The patient suffers from significant levels of dysfunctional hemoglobins (such
as carboxyhemoglobin or methemoglobin).
• ntravascular 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.
Symbol Definition
Follow instructions for use
Authorized European Representative
nformation
Manufacturer’s nformation
Serial Number
Recyclable
RX Only
Symbol Definitions
Symbol Definition
mportant Warning/Caution
Not made with natural rubber latex
Equipment type is BF
Hemoglobin Saturation
Heart Rate (BPM)
Low Power ndication
Not for Continuous Monitoring

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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 MR 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 physi-
cian or licensed healthcare practitioner.
WARNING: The pulse oximeter is intended only as an adjunct in patient assess-
ment. t must be used in conjunction with other methods of assessing clinical
signs and symptoms.
WARNING: Follow local ordinances and recycling instructions regarding dis-
posal or recycling of the device and device components, including batteries.
WARNING: This product may contain a chemical known to the state of California
to cause cancer, birth defects, or other reproductive harm.
CAU ION: Do not use the pulse oximeter in an explosive atmosphere.
CAU ION: 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 quali-
fied healthcare professional should interpret the data obtained on this device.
CAU ION: Check the pulse oximeter sensor application site frequently to deter-
mine the positioning of the sensor and circulation and skin sensitivity of the pa-
tient.
CAU ION: The pulse oximeter is not for continuous monitoring.
CAU ION: Prolonged use or the patient's condition may require changing the
sensor site periodically. Change sensor site and check skin integrity, circulatorys-
tatus, and correct alignment at least every 4 hours.
CAU ION: naccurate measurements may be caused by autoclaving, ethylene
oxide sterilizing, or immersing the sensors in liquid.
CAU ION: The device should not be used on an extremity with a blood pressure
cuff, arterial catheter, or intravascular line.

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Brief Description of Front Panel
Included Pulse Oximeter Accessories
• One (1) lanyard
• Two (2) AAA batteries
• One (1) user manual
• One(1) rubberized bumper
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. nsert 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 dis-
play. Always replace BOTH batteries at the same time
SpO2
Pulse Rate Signal
Intensity Bar Graph
Pulse Rate
Power Switch
Low Power
Indicator
SpO2
Waveform
1
2
(Figure 1)

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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. nsert 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.) ndex 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 re-
moved from the device.
(Figure 2)

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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
Handstand Horizontal
(4th click)
Pulse one Active
Alarm one Active
Normal Vertical
(5th click)
Pulse one Active
Alarm one Active
Handstand Vertical
(6th click)
Pulse one Active
Alarm one Active
Normal Horizontal
Wave Display
(Default Setting)
No Pulse one
Alarm one Active
Normal Horizontal
Wire Display
(2nd click)
Pulse one Active
Alarm one Active
Normal Horizontal
(3rd click)
Pulse one Active
Alarm one Active

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Alarm
On models equipped with an alarm, the alarm condition will appear when:
SPO2 < 90% / PR <60 or >100bpm
f 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. f the unit is in display modes
2-6 (audible mode), the unit will beep during measurement and will signal and alarm
condition with both visual and audible alerts.
Note: The alarm can be deactivated for 30 seconds by pressing the power
button once.
Note: This device is not intended for continuous patient monitoring.
Alarm sounds are for reference purposes only.
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. t 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. t 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. t is recommended that the product should be kept in a dry environment at
all times.
6. Please follow local ordinances when disposing of batteries.

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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.
roubleshooting Possible Problems
Problem Possible Reason Solution
1. Finger is not inserted correctly.
2. Patient SpO2 value is too low to
be measured.
1. Finger might not be inserted
deep enough.
2. Excessive patient movement.
1. No battery or low battery power.
2. Battery not installed correctly.
3. The monitor may be damaged.
1. The Oximeter is automatically
powered off, when no signal
was detected after 8 seconds.
2. The battery power is too low
to operate.
1. ERR 3 means the red emission
LED is damaged.
2. Err 4 means the infra-red
emission LED is damaged.
Err 6 means crystal damage.
Err 7 means all the emission LED or
reception dioxide is damaged.
SpO2% or pulse
rate do not display
normally.
SpO2% or pulse
rate is shown
unstably.
The monitor cannot
be powered on.
ndication is
suddenly off.
“Err 3” or “Err 4”
“Err 6”
“Err 7”
1. Retry inserting the finger.
2. There is excessive illumination.
3. Measure more times. f you determine the product
is working correctly, see your healthcare provider
for an exact diagnosis.
1. Retry inserting the finger.
2. Sit calmly and retry.
1. Replace battery.
2. Remove and reinstall battery.
3. Contact customer service center.
1. Normal.
2. Replace batteries.
1. Check the red emission LED.
2. Check the infra-red emission LED.
3. Return to Service Center
1. Return to Service Center
1. Return to Service Center

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Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
Guidance and Manufacturer’s declaration - electromagnetic environment specified below.
The customer or the user of the PULSE OX METER should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
For all Equipment and Systems
Guidance and Manufacturer’s declaration - electromagnetic environment specified below.
The customer or the user of the PULSE OX METER should assure that it is used in such an environment.
Electronic Environment Guidance
The PULSE OX METER uses very low RF energy only and
is not likely to cause interference to nearby electronic
equipment.
The PULSE OX METER is suitable for use in all establish-
ments,including domestic and those directly connected to
the public low-voltage power supply which powers build-
ings used for domestic purposes.
Emission est
RF Emissions C SPR11
RF Emissions C SPR11
Harmonic emissions EC
61000-3-2
Voltage fluctuations/
Flicker emissions EC
61000-3-2
Compliance Level
Group 1
Class B
Not applicable
Not applicable
Immunity est
Electrostatic Discharge
(ESD) EC 61000-4-2
Power Frequency (50/60
Hz) Magnetic Field EC
61000-4-8
IEC 60601 est
Level
+/- kV contact
+/- 8kV air
3A/m
Compliance
Level
+/- kV Contact
+/- 8kV air
3A/m
Electronic
Environment Guidance
Floors should be wood, concrete, or ceramic tile. f floor is
covered with synthetic material, the relative humidity should
be at least 30%.
Power frequency magnetic fields should be at levels charac-
teristic of a typical location in a typical commercial or hospital
environment.