ADC Diagnostix 2100 Directions For Use

Troubleshooting Possible Problems
Problem Possible Reason
SpO2% or pulse 1. Finger is not inserted correctly.
rate do not display 2. Patient SpO2 value is too low to
be measured.
normally.
SpO2% or pulse 1. Finger might not be inserted
rate is shown deep enough.
unstably. 2. Excessive patient movement.
The monitor cannot 1. No battery or low battery power.
2. Battery not installed correctly.
be powered on.
3. The monitor may be damaged.
Indication is 1. The Oximeter is automatically
suddenly off. powered off, when no signal
was detected after 8 seconds.
2. The battery power is too low
to operate.
"Err 3" or "Err 4" 1. ERR 3 means the red emission
LED is damaged.
2. Err 4 means the infra-red
emission LED is damaged.
"Err 6" Err 6 means crystal damage.
Err 7 means all the emission LED
"Err 7"
or reception dioxide is damaged.
Guidance and Manufacturer's Declaration
Electromagnetic Emissions
Guidance and Manufacturer' s declaration - electromagnetic environment specified below.
The customer or the user of the PULSE OXIMETER should assure that it is used in such an environment.
Emission Test Compliance Level
RF Emissions CISPR11 Group 1
RF Emissions CISPR11 Class B
Harmonic emissions Not applicable
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions Not applicable
IEC 61000-3-2
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 OXIMETER should assure that it is used in such an environment.
Immunity IEC 60601 Compliance
Test Test Level
Electrostatic Discharge +/- kV contact +/- kV Contact
(ESD) +/- 8kV air +/- 8kV air
IEC 61000-4-2
Power Frequency
(50/60 Hz) Magnetic Field 3 /m
IEC 61000-4-8
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
For all Equipment and Systems that are not Life-Supporting
Guidance and Manufacturer' s declaration - electromagnetic environment specified below.
The customer or the user of the PULSE OXIMETER should assure that it is used in such an environment.
Immunity IEC 60601 Compliance
Test Test Level Level
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
NOTE 1: t 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
structures, objects and people.
. Field strengths from fixed transmitters, such as base stations for radio, (cellular/cordless) telephones, and land mobile radios,
amateur radio, M/FM radio, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic en-
vironment due to fixed RF transmitters, an electromagnetic site survey should be considered. If measured field strength in the
location in which the Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional
measurements may be necessary, such as reorienting the location of the Pulse Oximeter.
B.Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Recommended Separation Distance Between Portable and Mobile RF communication equipment
and the Equipment or Systems
For all equipment and Systems that are not Life-Supporting
Recommended separation distances between portable and mobile RF communications equipment
and Pulse Oximeter
The Pulse Oximeter is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Pulse Oximeter can help prevent electromagnetic intereference by maintaining a minimum distance
between portable and recommended below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter (m)
Output power of
transmitter (W) 80 MHz to 800 MHz
0.01 0.1167
0.1 0.3689
1 1.1667
10 3.6893
100 11.6667
For transmitters rated at a maximum output power not listed above, the recommended separtaion distance (d) in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where (p) is the maximum output power rating of the transmitter in watts (w)
according to the transmitter manufacturer.
NOTE 1: t 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.

Technical Specifications

Display Type: OLED Display
SPO2 display range: 0-100%
PR Display Range: 30-235 BPM
PR Display Mode: Bargraph
Data Update Time: < 15 s
LED Wavelengths
Red: 660nm
Infrared: 940nm
Measurement range:
SPO2: 70-99% - 100% ±3%; s 70%
no definition
Pulse Rate: 30-235 BPM, ±2 bpm during the
pulse rate range of 30-99 bpm
and 2% during the pulse rate
range of 100-235 bpm.
ccuracy: ±2% on the stage of 80%-99%;
±3% on the stage of 70%-80%;
ccuracy: ±2 BPM or ±2% (larger)
Pulse Intensity: Bargraph Indicator
Power Requirements: Two alkaline Batteries
Power consumption: Less than 40m

Symbol Definitions

Symbol Definition
Important Warning/Caution
Latex-Free
Equipment type is BF
Hemoglobin Saturation
Heart Rate (BPM)
Low Power Indication
Declaration: EMC of this product comply with IEC60601-1-2 standard.
Measurement Performance in Low Perfusion Condition: required the test equipment (BIO-TEK INDEX Pulse Oximeter
tester) the pulse wave is available without failure when the simulation pulse wave amplitude is at 6%.
Interference Resistance Capacity against mbient Light: Device work normally when mixed noise produced by BIO-TEK
INDEX Pulse Oximeter tester.
Solution
1. Retry inserting the finger.
2. There is excessive illumination.
3. Measure more times. If 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
Electronic Environment Guidance
The PULSE OXIMETER uses very low RF energy
only and is not likely to cause interference
to nearby electronic equipment.
The PULSE OXIMETER is suitable for use
in all establishments,including domestic and
those directly connected to the public
low-voltage power supply which powers
buildings used for domestic purposes.
Electronic
Level Environment Guidance
Floors should be wood, concrete, or ceramic tile.
If floor is covered with synthetic material, the
relative humidity should be
at least 30%.
Power frequency magnetic fields should be at
3 /m levels characteristic of a typical location in a typical
commercial or hospital environment.
Electronic
Environment Guidance
Portable and mobile RF communications equipment should not be
used close to any part of the Pulse Oximeter, including cables.
The recommended separation distance should be calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
80MHZ to 800MHZ
800MHZ to 2.5GHz
Where P is maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer
and (d) is the recommended separation distance in meters (m).
Where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d
is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey. should be less than the compliance
level in each frequency range.
800 MHz to 2.5 GHz
0.2334
0.7378
2.3334
7.3786
23.3334
Low power indication:
Battery Life: (2) "
alkaline batteries Can
operate as long as
30 hours (continious).
Dimension:
Length: 2.3" (58mm)
Width: 1.3" (32mm)
Height: 1.3" (34mm)
Weight: 1.8oz. (50g)
(including two
batteries)
Environment:
Operation Temperature: 41°F - 104°F (5°C - 40°C)
Storage Temperature: 14°F - 104°F (-10°C - 40°C)
Relative Humidty: 15%-80% in operation /
10%-80% in storage
Finger Range: .31" - .98" (.8cm-2.5cm)
Minimum Weight: 20lbs. (13kg)
Symbol Definition
Not for Continuous Monitoring
Conforms to EU Standards
uthorized European Represenative' s
Information
Manufacturer' s Information
Serial Number
DC
Fingertip Pulse Oximeter
merican Diagnostic Corporation ( DC
terials and workmanship under normal use and service as follows:
1. Warranty service extends to the original retail purchaser only and commences with
the date of delivery.
2. Your Pulse Oximeter is warranted for two (2) years from date of purchase (all parts).
What is Covered: Replacement of parts, and labor.
What is Not Covered: Transportation charges to and from DC
by abuse, misuse, accident, or negligence. Incidental, special, or consequential dam-
ages. Some states do not allow the exclusion or limitation of incidental, special, or
consequential damages, so this limitation may not apply to you.
To Obtain Warranty Service: Send item(s) postage paid to DC
Dept., 55 Commerce Dr., Hauppauge, NY 11788. Please include your name and ad-
dress, phone no., proof of purchase, and a brief note explaining the problem.
Implied Warranty: ny implied warranty shall be limited in duration to the terms of
this warranty and in no case beyond the original selling price (except where prohibited
by law).
This warranty gives you specific legal rights and you may have other rights which vary
from state to state.
" 1.5V, 600m h
IB p/n 93-2100-00 rev 4
®
Diagnostix TM 2100
Warranty
® ) warrants its products against defects in ma-
To register your product visit us at
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DC
55 Commerce Drive
Hauppauge, NY 11788
DC (UK) Ltd.
Unit 6, PO14 1TH
United Kingdom
0197
Directions
for Use
®
® . Damages caused
® , ttn: Repair
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