Oximeter Plus C21 User manual

Manufactured for:
Oximeter Plus, Inc.
18 Milburn Lane
Roslyn Heights, NY 11577
Phone: [phone]
Oximeter Plus, Inc.
C21 Fingertip Pulse Oximeter
USER MANUAL Ver1.0
General Description
Oxygen binds to hemoglobin in red blood cells when moving through the lungs. It is transported throughout the body as arterial
blood. Apulse 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 pulsating arteriolar vascular bed. The
sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, whichis 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 Emission Tube
2. Red and Infrared-ray Receipt Tube
Precautions For Use
1．Before use, carefully read the manual.
2．Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
3．The fingertip 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 fingertip pulse oximeter in an MRI or CT environment.
5．Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms. It is not for
continuous monitoring.
6．Do not use the fingertip pulse oximeter in an explosive atmosphere.
7．The fingertip 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
13．This equipment is not intended for use during patient transport outside the healthcare facility.
14．This equipment should not be used adjacent to or stacked with other equipment.
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．These materials that contact with the patient’s skin contain medical silicone and ABS plastic enclosure are all pass the
ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
17．When the signal is not stable, the reading may be inaccurate. Please do not reference.
Rx only: “Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.”
Contraindication
It is not for continuous monitoring.
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 Features
1．Simple to operate and convenient to carry.
2．Small volume, light weight and low power consumption.
3．Dual color OLED displays SpO2, PR, Pulse bar, and waveform.
4．6 display modes
5．Level 1-10 adjustable brightness.
6．2pcs AAA-size alkaline batteries; real-time battery status indication.
7．Weak or unstable signal prompt provides more accurate measurements.
8．When no signal or low signal is detected, the pulse oximeter will power off automatically in 8 seconds
9．Multiple-patient reusability.
Intended Use
The Fingertip Pulse Oximeter MD300C21 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 is recommended
that you do not move your body while taking a reading.
5 Read the data from the display screen
6 Press 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.
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:
Front Panel
Note:
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2 or pulse rate value is potentially incorrect.
Battery Installation
1. 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.
2. Slide the battery door cover horizontally along the arrow shown as the picture.
Notes:
²Please remove the batteries if the pulse oximeter will not be used for long periods of time.
²Please replace the battery when the power indicator starting flickering.
Using the Lanyard
1．Thread thinner end of the lanyard through the loop.
2．Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
²Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking
hazards.
²Do not hang the lanyard from the device’s electrical wire.
²Please 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.
Cleaning the fingertip pulse oximeter
Please use medical alcohol to clean the silicone touching the finger inside of oximeter with a soft cloth dampened with 70%
isopropyl alcohol. Also clean the being tested finger using alcohol before and after each test.
Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter to
dry thoroughly before reuse.
The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries.
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:
lAn error in the Possible Problems and solutions is displayed on screen.
lThe oximeter cannot be powered on in any case and not the reasons of battery.
lThere 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.
Disinfecting
The applied parts touching the patients’ body are required to be disinfected once after each use. The recommended disinfectants
include: ethanol 70%, isopropanol 70%, glutaraldehyde-type 2% liquid disinfectants.
Disinfection may cause damage to the equipment and is therefore not recommended for this pulse oximeter unless otherwise
indicated in your hospital’s servicing schedule. Clean the pulse oximeter before disinfecting it.
CAUTION: Never use EtO or formaldehyde for disinfection.
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%
3. Pulse Rate
Display range: 30bpm~250bpm
Measure range: 30bpm~250bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100~250bpm, ±2%
Resolution: 1bpm
4. Probe LED Specifications
Wavelength
Radiant Power
RED
660±3nm
3.2mW
IR
905±10nm
2.4mW
5. Power Requirements
TwoAAA 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 Response Time
As shown in the following figure.
Response time 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（The application part is rubber inside of the
Pulse Oximeter）;
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 for MD300C21 is shown as following:
ARMS ValueAnalysis 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
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
shown unstably 1. Finger might not be inserted deep enough. 2. Excessive patient movement 1. Retry by inserting the finger 2. Be calmness
The oximeter
cannot 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
“Error3” or
“Error4” is
displayed on
screen
1. Err 3 means the red emission LED is
damaged
2. Err 4 means the infra-red emission LED is
damaged
1. Check the red emission LED
2. Check the infra-red emission LED
Error 6 Err 6 means the screen is failure Please contact with local customer service
centre
“Error7” is
displayed on
screen
Err 7 means all the emission LED or reception
diode is damaged. Please contact with local customer service centre
Symbol Definitions
Symbol Definition Symbol Definition
Type BF applied part. Attention
IP22 Protected against dripping water. SpO2
﹪
Oxygen saturation
PR bpm Pulse rate (BPM) Low power indication
No SpO2Alarm SN Serial No.
Storage temperature and relative
humidity Follow instruction for use
Manufacturer’s information Date of Manufacture
Power Switch RX ONLY Prescription (Rx) Only
Waste electrical and electronic
equipment
Box Content
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
Applicable Models
C21
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.
ALL RIGHTS RESERVED
Revised Date: November 10, 2016