ChoiceMMed Fingertip Pulse Oximeter User manual

Fingertip
Pulse Oximeter
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 pulsating arteriolar vascular bed. 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 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 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 High brightness LED/LCD display SpO2, PR, and Pulse bar.
2 Two display modes. (NOTE: except for LCD series)
3 2 pcs AAA-size alkaline batteries; battery-low indicator.
4 When no operation 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 is recommended
that you do not move your body while taking a reading.
5．Read the data from the display screen. There are two display modes. After turning on the pulse oximeter, each time you
press the power switch, the pulse oximeter will switch to another display modes. (NOTE: only for the LED series)
Front Panel
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2and 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.
Note:
Please remove the batteries if the pulse oximeter will not be used for long periods of time.
Please 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!
Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.
Do not hang the lanyard from the device’s electrical wire.
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.
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:
An error in the Possible Problems and solutions is displayed on screen.
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.
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
LED/LCD display
2. SpO2
Display range: 0%~100%
Measurement range: 70%~100%
Accuracy: 70%~100%±2digits; 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 9919:2005, 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: 0bpm~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.
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 18 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: IPX22
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 is shown as following:
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
Declaration
Guidance and Manufacturer’s declaration – electromagnetic emissions-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic emission
The MD300C1 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of MD300C1 Pulse Oximeter should assure that it is used in such an environment.
Emission test Compliance Electromagnetic Environment – guidance
RF emissions CISPR 11 Group 1 The MD300C1 Pulse Oximeter uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions CISPR 11 Class B The pulse Oximeter (MD300C1) is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Harmonic emissions IEC 61000-3-2 Not Applicable
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not Applicable
Guidance and Manufacturer’s declaration – electromagnetic immunity-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic immunity
The MD300C1 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the MD300C1 Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
Level
Electromagnetic Environment – guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
+/- 6kV contact
+/- 8kV air
+/- 6kV contact
+/- 8kV air
Floors should be wood, concrete or ceramic tile. If
floor are covered with synthetic material, the relative
humidity should be at least 30%.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be at levels
characteristics of a typical location in a typical
commercial or hospital environment.
Guidance and Manufacturer’s declaration – electromagnetic immunity-
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacturer’s declaration - electromagnetic immunity
The MD300C1 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the MD300C1 Pulse Oximeter should assure that it is used in such an environment.
Immunity
test
IEC 60601 test
level
Compliance
Level
Electromagnetic Environment – guidance
Radiated
RF
IEC
61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m Portable and mobile RF communications equipment should be
used no closer to any part of the Pulse Oximeter (MD300C1),
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz 800 MHz to 2.5 GHz
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 surveya, should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of equipment marked with
following symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
a Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Pulse Oximeter (MD300C1) should be observed to verify normal operation.
If abnormal performance is observed, additional measurements may be necessary, such as reorienting of the relocating the
Pulse Oximeter (MD300C1).
b Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/m
Recommended separation distances between portable and mobile RF communications 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 (MD300C1)
The Pulse Oximeter (MD300C1) is intended for use in electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Pulse Oximeter (MD300C1) can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse
Oximeter (MD300C1) as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01 0.1167 0.2334
0.1 0.3689 0.7378
1 1.1667 2.3334
10 3.6893 7.3786
100 11.6667 23.3334
For transmitters rated at a maximum output power not listed above, the recommended separation distanced 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 At 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.
Possible Problems and Solutions
Problems Possible reason Solution
SpO2or PR can not
be shown normally
1. Finger is not inserted correctly
2. Patient’s Oxyhemoglobin value is too low to be
measured
1.Retry by inserting the finge
r
2. 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. Finger is trembling or patient’s body is in movement
status.
1. Retry by inserting the finge
r
2. Try not to move
The oximeter can not
be powered on
1. Power of batteries might be inadequate or not be
there at all.
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. Power quantity of the batteries is started being
inadequate
1. Normal
2. Replace the batteries
“Error7” is displayed
on screen
1. Low power
2. Emission tube damaged.
3. Current control circuit malfunctions.
1 Please change battery
2 Please contact local customer service center
3 Please contact local customer service center
Symbol Definitions
Symbol Definition Symbol Definition
Type BF applied part. Attention.
IP22 The degree of protection against ingress of water ﹪SpO2Oxygen saturation
Pulse rate (BPM) Low power indication
No SpO2Alarm Power switch
Storage temperature and relative humidity Follow instruction for use
Date of Manufacture SN Serial No.
European union approval
Manufacturer’s information
Authorized representative in the European community Conformity to WEEE Directive
Box Content
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
Applicable Models
MD300C1 series:
LED screen
MD300C1 MD300C12 MD300C13 MD300C15 MD300C16 MD300C17 MD300C18 MD300C19 MD300C1A
MD300C1B MD300C1C MD300C1D MD300C1E MD300C1F MD300C1G MD300C1H MD300C1I
LCD screen
MD300C15D MD300C15F MD300C150
MD300C4 series:
LED screen:
MD300C4 MD300C41 MD300C42 MD300C11
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: March 2, 2017
Version：Ver1.0