dynarex Resp-O2 36402 User manual

General Description
Oxygen binds to hemoglobin in red blood cells when moving through the lungs. It is transported throughout the body as arterial
blood. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage (%) of hemoglobin in the blood
that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. A pulse oximeter also measures and
displays the pulse rate at the same time it measures the SpO2level.
Measurement Principle
Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light
source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red
light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger
sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally
pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of
light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as
SpO2.
Diagram of Operation Principle
1. Red and Infrared-ray Detector
2. Red and Infrared-ray Light Source
Precautions For Use
1. Before use, carefully read the manual.
2. Operation of the pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
3. The pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2measurement. Verify that nothing is
hindering the pulse measurement before relying on the SpO2measurement.
4. Do not use the pulse oximeter in an MRI or CT environment.
5. Do not use the pulse oximeter in situations where alarms are required. The device has no alarms. It is not for continuous
monitoring.
6. Do not use the pulse oximeter in an explosive atmosphere.
7. 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.
8. In order to ensure correct sensor alignment and skin integrity, the maximum application time at a single site for our device should
be less than half an hour.
9. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not
intended for sterilization.
10. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,
including batteries.
11. This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equipment and/or
systems. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in
healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source
might disrupt the performance of this device.
12. Portable and mobile RF communications equipment can affect medical electrical equipment.
The portable and mobile RF communications equipment should be used no closer than 30cm (12 inches) to any part of the device,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
13. This equipment is not intended for use during patient transport outside the healthcare facility.
14. The patient is an intended operator. All functions of the device can be safely used by the patient.
15. It may be unsafe to:
—use accessories, detachable parts and materials not described in the instructions for use
—interconnect this equipment with other equipment not described in the instructions for use
—disassemble, repair or modify the equipment
16. The material that contact with the patient’s skin has passed the ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests
for irritation and delayed-type hypersensitivity.
17. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating
normally.
18. The use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
19. When the signal is not stable, the reading may be inaccurate, please do not refer.
20. The material of the device has no nature latex.
21. The pulse oximeter equipment is calibrated to display functional oxygen saturation.
Rx only: “Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.”
Contraindication
Not yet found.
Inaccurate measurements may be caused by
1．Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin).
2．Intravascular dyes such as indocyanine green or methylene blue.
3．High ambient light. Shield the sensor area if necessary.
4．Excessive patient movement.
5．High-frequency electrosurgical interference and defibrillators.
6．Venous pulsations.
7．Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
8．The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9．The patient is in cardiac arrest or is in shock.
10．Fingernail polish or false fingernails.
11．Weak pulse quality (low perfusion).
12．Low hemoglobin.
Product Properties
1. Simple to operate and convenient to carry.
2. Small volume, light weight and low power consumption.
3. OLED display SpO2, PR, and Pulse bar.
4. Level 1-10 adjustable brightness.
5. 6 display modes.
6. 2pcs AAA-size alkaline batteries; battery-low indicator.
7. When no or low signal is detected, the pulse oximeter will power off automatically in 8 seconds.
Intended Use
The Fingertip Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial
hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.
Operation Instructions
1. Install two AAA batteries according to the Battery Installation instructions.
2. Place one of your fingers into the rubber opening of the pulse oximeter.
3. Press the switch button one time on front panel to turn the pulse oximeter on.
4. Keep your hands still for the reading. Do not shake your finger during the test. It isrecommended that you do not move your
body while taking a reading.
5. Read the data from the display screen.
6. Press the button again to toggle between six display modes.
After turning on the Oximeter, each time you press the power switch, the Oximeter will switch to another display mode.
There are 6 display modes shown as follows:
Holding the power switch for longer than one second will adjust the brightness of the oximeter. There are 10 levels of brightness.
The default is level four.
Front Panel
Notes：
1. The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2and pulse rate value is potentially incorrect.
2. If the screen displays “?”, it means the signal is unstable, please keep your hands still and retry.
Battery Installation
1. Open the battery door cover shown as the picture.
2. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the
polarities are not matched, damage may be caused to the oximeter.
3. Close the battery door cover.
Note:
Please remove the batteries if the pulse oximeter will not be used for long periods of time.
Please replace the battery when the low battery power indicator.
Using the Lanyard
1. Thread thinner end of the lanyard through the hanging hole.
2. Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
1. Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.
2. Do not hang the lanyard from the device’s electrical wire.
3. Please notice that the lanyard which is tied to the oximeter may cause strangulation due to excessive length.
Maintenance and Storage
1. Replace the batteries in a timely manner when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for patients.
3. Remove the batteries if the oximeter is not operated for a long time.
4. It is best to store the product in -25℃~+70℃and ≤93% humidity.
5. Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.
6. Dispose of battery properly; follow any applicable local battery disposal laws.
Clean and disinfect the device
It is recommended to clean and disinfect the silicone touching the finger inside of device with a soft cloth dampened with
recommended alcohol of 70% isopropyl or 70% ethanol before and after each use.
Excessive disinfection may cause damage to the device and is therefore not recommended for this device unless otherwise
indicated in your hospital’s servicing schedule.
Do not pour or spray liquids onto the device and do not allow any liquid to enter any openings in the device. Allow the device to
dry thoroughly before reuse.
The Fingertip Pulse Oximeter requires no routine calibration or maintenance other than replacement of batteries.
Caution: Never use EtO (ethylene oxide) or formaldehyde for disinfection.
The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one measurement.
Stop using and contact local service center if one of the following cases occurs:
Any of the problems in the Possible Problems and solutions cannot be solved.
The oximeter cannot be powered on in any case and not the reasons of battery.
There is a crack on the oximeter or damage on the display resulting readings cannot be identified; the spring is invalid; or the
key is unresponsive or unavailable.
Specifications
1. Display Type
OLED display
2. SpO2
Display range: 0%~100%
Measurement range: 70%~100%
Accuracy: 70%~100% ±2%; 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 SpO2accuracy. The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial
hemoglobin oxygen (SaO2) 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 SpO2range 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.
The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3.
3. Pulse Rate
Display range: 30bpm~250bpm
Measure range: 30bpm~250bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~250bpm, ±2%
Resolution: 1bpm
4. Probe LED Specifications
Wavelength
Radiant Power
RED
660
±
3nm
3.2mW
IR
905±10nm
2.4mW
NOTE: The information about wavelength range can be especially useful to clinicians.
Fingertip Pulse Oximeter (Pediatric)
Reorder No. 36402

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. Environment Requirements
Operation Temperature: 5~40
Storage Temperature: -25~+70
Ambient Humidity: 15%~93% no condensation in operation; ≤93% no condensation in storage/transport
Atmosphere pressure: 70kPa~106kPa
7. Equipment data update period
As shown in the following figure. Data update period of slower average is 8s.
8. 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
0.40
-0.48
ARMS
1.66
1.46
1.93
Bland-Altman Plot Graphic
Electromagnetic Compatibility
The device conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard.
Essential performance is defined as SpO2accuracy and pulse rate accuracy or an indication of 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: Harmonic 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)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Rated power Frequency Magnetic Fields
IEC 61000-4-8
30 A/m
50Hz and 60 Hz
Radiated RF
IEC 61000-4-3
80 MHz – 2.7 GHz
10 V/m 80% AM 1kHz
380 – 390 MHz
27 V/m Pulse mod. 18Hz
430 – 470 MHz
28 V/m FM±5Hz deviation 1kHz sine
704 – 787 MHz
9 V/m Pulse mod. 217Hz
800 – 960 MHz
28 V/m Pulse mod. 18Hz
1.7 – 1.99 GHz
28 V/m Pulse mod. 217Hz
2.4 – 2.57 GHz
28 V/m Pulse mod. 217Hz
5.1 – 5.8 GHz
9 V/m Pulse mod. 217Hz
Note: Electrical Fast Transients (IEC 61000-4-4), Surge (IEC 61000-4-5), Voltage dips (IEC 61000-4-11), Conducted Immunity
(IEC 61000-4-6) are not applicable.
Possible Problems and Solutions
Problems
Possible reason
Solution
SpO2or PR can
not
be shown normally
1. Finger is not inserted correctly
2. Patient’s SpO2value is too low to be measured
1. Retry by inserting the finger
2. There is excessive illumination
3. Try some more times. If you can make sure
no
problem exist in the product, please go to
a
hospital timely for exact diagnosis.
SpO2or PR is sho
wn
unstably
1. Finger might not be inserted deep enough.
2. Excessive patient movement
1. Retry by inserting the finger
2. Be calmness
The oximeter cann
ot
be powered on
1. No battery or low power of battery
2. Batteries might be installed incorrectly
3. The oximeter might be damaged
1. Please replace batteries
2. Please reinstall the batteries
3. Please contact with local customer service centre
Indication lamps
are
suddenly off
1. The product is automatically powered off when no
signal is detected longer than 8 seconds
2. The battery power is too low to work
1. Normal
2. Replace the batteries
“Err7” is displayed
on
screen
Err 7 means all the emission LED or reception diode
is damaged. Check the emission LED and reception diode.
Symbol Definitions
Symbol Definition Symbol Definition
Type BF applied part. Caution
Follow instructions for use Low power indication
No SpO2Alarm ﹪SpO2Oxygen saturation
IP22 Protected against dripping water.
Serial No.
PR bpm Pulse rate (BPM)
?
Indicate the signal is not stable
Date of Manufacture
Waste electrical and electronic
equipment
Box Contents
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One
Silicon rubber boot
user manual
5.
Manufactured for: Dynarex Corporation
10 Glenshaw Street • Orangeburg, NY 10962
USA • www.dynarex.com
Made in China R210909
Notes
1. The illustrations used in this manual may differ slightly from the appearance of the actual product.
2. The specifications are subject to change without prior notice.
-13°F
-25°C
+158°F
+70°C
0%
93%
Non-ionizing electromagnetic
radiation
Does not contain Phthalates (DEHP)
Prescription use only
Temperature limit
Humidity limitation
Batch code