ChoiceMMed MD300C5 User manual

Fingertip
Pulse Oximeter
USER MANUAL
Ver6.0C5
General Description
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity, compounded with oxygen, by all combinative hemoglobin
(Hb) capacity in blood. In other words, it is 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 (HbO2) in red and near-infrared zones.
Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity
Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 940nm 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 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 60601-1-2:2007 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.
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 Do not disassemble, repair or modify the equipment without authority.
16 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
17 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.
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 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
Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate of pediatric patients in hospitals and hospital-type facilities.
Operation Instructions
1 Install two AAAbatteries 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 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:
1. 2. 3 4 5 6.
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
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2and pulse rate value is potentially incorrect.
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 -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. SpO2
Display range: 0%~99%
Measurement range: 70%~99%
Accuracy: 70%~99%: ±3%; 0%~69% no definition
Resolution: 1%
Note：
Afunctional 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~254bpm
Measure range: 30bpm~235bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~235bpm, ±2%
Resolution: 1bpm
4. Probe LED Specifications
Wavelength
Radiant Power
RED
660±2nm
1.8mW
IR
940±10nm
2.0mW
MD300C5

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 12.4s.
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 MD300C5 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of MD300C5 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 MD300C5 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 (MD300C5) 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 MD300C5 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the MD300C5 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 MD300C5 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the MD300C5 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 (MD300C5), 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.
aField 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 (MD300C5) 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 (MD300C5).
bOver 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 (MD300C5)
The Pulse Oximeter (MD300C5) is intended for use in electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Pulse Oximeter (MD300C5) can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse
Oximeter (MD300C5) 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 cannot
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
Change the screen
“Error7” 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
Type BF applied part.
Caution
Follow instructions for use
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
Manufacturer’s information
Date of Manufacture
Waste electrical and electronic equipment
European union approval
Authorized representative in the European community
Box Contents
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One user manual
5. One silicone case
6. One carrying bag
Applicable Models
MD300C5 MD300C52 MD300C53 MD300C54
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 28，2014