ADC Adimals 2150 Instructions For Use

Specifications
1. Display Type: OLED display
2. SpO :
2
Display range: 0%~100%
Measurement range: 70~100%
Accuracy: 70%~100% ±2 digits; 0%~69% no definition
Resolution: 1%
Note: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used
to establish the SpO 2 accuracy. The measured arterial hemoglobin saturation value (SpO 2 ) of the sensors is compared to arterial
hemoglobin oxygen (SaO 2 ) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors
in comparison to the CO-oximeter samples measured over the SpO 2 range of 70%~100%. Accuracy data is calculated using
the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment–Particular requirements
for the basic safety and essential performance of pulse oximeter equipment for medical use.
A functional tester is used to measure how accurately fingertip pulse oximeter is reproducing the specified calibration curve and
the PR accuracy.
3. Pulse Rate:
Display range: 0bpm~250bpm
Measurement range: 30~250BPM
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~250bpm, ±2% bpm
Resolution: 1bpm
4. Probe LED Specifications:
Wavelength Radiant Power
RED 660±3nm 3.2mW
IR 905±10nm 2.4mW
The information about wavelength range can be especially useful to clinicians.
5. Power Requirements:
Two AAA alkaline batteries
Power consumption: Less than 40mA
Battery life: Two AAA 1.5V, 1200mAh alkaline batteries could
be continuously operated as long as 24 hours.
6. Dimensions:
Length: 2.19'' (5.5cm)
Width: 1.13'' (2.9cm)
Height: 1'' (2.5cm)
Weight: 1.76 oz (50g) (including two AAA batteries)
7. Environmental Requirements:
Operation temperature: 41°F~104F (5°C~40°C)
Storage temperature: -13°F~158°F (-25°C~70°C)
Ambient humidity: 15%~93% no condensation in operation;
≤93% no condensation in storage/transport
Atmosphere pressure: 70kPa~106kPa
8. Equipment data
update period:
As shown right, the average
data update period is 8s.
9. Classification:
According to the type of
protection against electric shock: Internally powered equipment.
According to the degree of protection against electric shock: Type BF Applied
Part (applied part: the rubber hole of the device);
According to the degree of protection against ingress of water: IP22
According to the mode of operation: Continuous operation.
Clinical Study Summary
The following details are provided to disclose actual performance observed in the clinical validation
study of healthy adult volunteers. The ARMS value analysis statement and Bland-Altman plot of
data are shown as follows:
ARMS Value Analysis Statement
Item 90~100 80~<90 70~<80
#pts 78 66 63
Bias 1.02 0.4 -0.48
ARMS 1.66 1.46 1.93
Standards
This equipment complies with IEC 60601-1-2:2014 for electromagnetic
compatibility for medical electrical equipment and/or systems.
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 Ambient Light: Device work nor-
mally when mixed noise produced by BIO-TEK INDEX Pulse Oximeter tester.
Electromagnetic Compatibility
The device conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard.
Essential performance is defined as SpO accuracy and pulse rate accuracy or an indication of
2
abnormal operation. Accuracies may be affected as a result of exposure to electromagnetic
disturbances that are outside of the environments listed in the intended use. If issues are
experienced, move the device away from the source of electromagnetic disturbances.
Table 1: Electromagnetic Emissions Limits and Compliance
Emissions Test Compliance
RF Emissions CISPR 11 Group 1, Class B
Note: Harmonics Emissions (IEC 61000-3-2), Voltage Flicker Emissions (IEC 61000-3-3 are not applicable.
Table 2: Electromagnetic Immunity
Immunity Test Compliance
Electrostatic Discharge (ESD) ±8 kV contact
IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Rated Power Frequency
30 A/m
Magnetic Fields
IEC 61000-4-8 50 Hz and 60 Hz
Radiated RF 80 MHz - 2.7 GHz
IEC 61000-4-3 380 - 390 MHz
430 - 470 MHz
704 - 787 MHz
800 - 960 MHz
1.7 - 1.99 GHz
2.4 - 2.57 GHz
5.1 - 5.8 GHz
Note: Electrical Fast Transients (IEC 61000-4-4), Surge (IEC 61000-4-5), Voltage dips (IEC61000-4-1),
Conducted Immunity (IEC 61000-4-6) are not applicable.
Troubleshooting Solutions
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.
1. Finger might not be inserted
SpO2% or pulse
rate is shown deep enough.
unstably. 2. Excessive patient movement.
1. No battery or low battery power.
The monitor cannot
be powered on. 2. Battery not installed correctly.
3. The monitor may be damaged.
1. The oximeter is automatically
Indication is
powered off, when no signal
suddenly off.
was detected after 8 seconds.
2. The battery power is too low
to operate.
1. Low power
2. Emission tube damaged
"Err 7"
3. Current control circuit malfunction
10 V/m 80% AM 1kHz
27 V/m Pulse mod. 18Hzn
28 V/m FM±5Hz deviation
1kHz sine
9 V/m Pulse mod. 217Hz
28 V/m Pulse mod. 18Hz
28 V/m Pulse mod. 217Hz
28 ZV/m Pulse mod. 217Hz
9 V/m Pulse mod. 217Hz
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. Change batteries.
2. Return to service center
3. Return to service center
®
ADC Adimals
Fingertip Pulse Oximeter
Instructions
for Use
Warranty
American Diagnostic Corporation (ADC
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 years from date of purchase.
What Is Covered: Replacement of parts, and labor.
What Is Not Covered: Transportation charges to ADC. Batteries where supplied. Damages
caused by abuse, misuse, accident, or negligence. Incidental, special, or consequential damages.
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 ADC, Attn: Repair Dept., 55
Commerce Dr., Hauppauge, NY 11788. Please include your name and address, phone no.,
proof of purchase, and a brief note explaining the problem.
Implied Warranty: Any 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.
To register your product visit us at
www.adctoday.com/support/warranty-registration
FOR QUESTIONS, COMMENTS, OR SUGGESTIONS CALL TOLL FREE:
1-800-ADC-2670
www.adctoday.com/feedback
This manual is available online in a variety of
languages, follow the links for language options.
www.adctoday.com/care
Beijing Choice
Electronic Technology Co., Ltd.
2nd Fl, 3rd Fl and Rm 410-412 4th Fl
No. 2 Bldg, No. 9 Shuangyuan Rd
Shijingshan District
100041,Beijing, P.R.C.
Shanghai International
Holding Corp. GmbH (Europe)
EiffestraBe 80, 20537
Hamburg, Germany
IB p/n 93-2150-00 rev 10 (8/11/2021)
®
2150 Pediatric
® ) warrants its products against defects in materials
OR VISIT
Mfg. for: ADC
55 Commerce Drive
Hauppauge, NY 11788
Inspected in the U.S.A.
Made in China
tel: 631-273-9600
1-800-232-2670
fax: 631-273-9659
www.adctoday.com
0123
Printed in China
®
®