ChoiceMMed MD300C2ES User Manual

Fingertip Pulse Oximeter
MD300C2ES USER MANUAL

General Description

Oxygen Saturation is a percentage of Oxyhemoglobin (HbO ) capacity, compounded with oxygen, by all combinative hemoglobin (Hb) capacity in blood. In other words, it is
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consistency of Oxyhemoglobin in blood. It is a very important parameter for the Respiratory Circulation System. Many respiratory diseases can result in oxygen saturation being
lowered in human blood. Additionally, the following factors can reduce oxygen saturation: Automatic regulation of organ dysfunction caused by Anesthesia, Intensive Postoperative
Trauma, injuries caused by some medical examinations. That situation might result in light-headedness, asthenia, and vomiting. Therefore, it is very important to know the oxygen
saturation of a patient so that doctors can find problems in a timely manner.
The fingertip pulse oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate
and oxygen saturation will appear on the display. It has been proven in clinical experiments that it also features high precision and repeatability.

Measurement Principle

Principle of the oximeter is as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive
hemoglobin (RHb) and Oxyhemoglobin (HbO ) in red and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in
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accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused
onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in
electronic circuits and microprocessor.

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 SpO
before relying on the SpO measurement.
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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 60601-1-2:2007 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.
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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.
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 Properties

1 Simple to operate and convenient to carry.
2 Small volume, light weight and low power consumption.
3 High brightness OLED display SpO , PR, and Pulse bar; two directions display mode.
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4 2 display modes.
5 2pcs AAA-size alkaline batteries; battery-low indicator.

Intended Use

The Fingertip Pulse Oximeter is only for sports and aviation use. It is ideal for use during sports activities, mountain climbing and piloting airplanes. It is not intended to diagnosis any
medical condition or to be used in medical applications.

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 After take out the finger, the measurement data displays in the screen for 5 seconds and then the pulse oximeter will power off automatically in 5 seconds.
7 Press the button again to toggle between two display modes.
After turning on the Oximeter, each time you press the power switch, the Oximeter will switch to another display mode. There are 2 display modes shown as follows:
1.
Holding the power switch for longer than one second, will adjust the brightness of the oximeter. There are 10 levels of brightness. The default level is level four.
Front Panel
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO

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 low battery power indicator.

Using the Lanyard
1. Thread thinner end of the lanyard through the loop.
Ver1.0
measurement. Verify that nothing is hindering the pulse measurement
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2.
and pulse rate value is potentially incorrect.
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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.

1. 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 -20℃～+55℃ 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 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.


Specifications

1. Display Type
OLED display
2. SpO
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Display range: 0%~100%
Measurement range: 70%~100%
Accuracy: 70%~100%: ±2%; 0%~69% no definition
Resolution: 1%
ARMS Value Analysis
Testing Range
70--<80
80--<90
90--100
70--100
Bland-Altman graphical plot of all sampled data points as below
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
hemoglobin saturation value (SpO ) of the sensors is compared to arterial hemoglobin oxygen (SaO
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accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO
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~254bpm
Measure range: 30bpm~235bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~235bpm, ±2%
Resolution: 1bpm
4. LED Wavelengths
Wavelength Radiant Power
660
±
RED 3.2mw
3nm
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 30mA
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated as long as 30 hours.
6. Environment Requirements
Operation Temperature: 5℃～40℃
Storage/ Transport Temperature: -20℃～+55℃
Ambient Humidity: ≤80% no condensation in operation; ≤93% no condensation in storage/transport
Atmosphere pressure: 86kPa～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: IPX1
According to the mode of operation: CONTINUOUS OPERATION
Declaration
Guidance and Manufacturer's declaration – electromagnetic emissions-For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer's declaration - electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of 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 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 is suitable for use in all establishments, including domestic establishments and those
Harmonic emissions Not Applicable directly connected to the public low-voltage power supply network that supplies buildings used for domestic
IEC 61000-3-2 purposes.
Voltage fluctuations/ flicker emissions Not Applicable
IEC 61000-3-3
Guidance and Manufacturer's declaration – electromagnetic immunity-For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer's declaration - electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such
an environment.
Immunity test IEC 60601 test Compliance
level Level
Electrostatic +/- 6kV contact +/- 6kV contact
Discharge (ESD) +/- 8kV air +/- 8kV air
IEC 61000-4-2
Data Points Bias ARMS Specification
81 -0.70 1.82 ±2
71 -0.60 1.52 ±2
84 -0.15 1.78 ±2
236 -0.47 1.72 ±2
) value, determined from blood samples with a laboratory CO-oximeter. The
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range of 70%~100%. Accuracy data is calculated using the root-mean-squared (Arms
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Electromagnetic Environment – guidance
Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the
relative humidity should be at least 30%.
accuracy. The measured arterial
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