Beijing Choice Electronic Technology MD300C1 Operator's Manual

OPERATOR'S
MANUAL
VER1.0C1
Fingertip Pulse Oximeter
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 small size, low power consumption, convenient operation and portability. It is only
necessary for a patient to put one of his fingers into the fingertip photoelectric sensor for diagnosis, and a display screen will
show oxygen saturation. 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 glow 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 glow
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 shown on the Oximeter's display through electronic circuits and a microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
Precautions for use
Do not use the pulse oximeter in an MRI or CT environment
1
Do not use the pulse oximeter in situations where alarms are required. The device has no alarms.
2
Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
3
The pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with other
4
methods of assessing clinical signs and symptoms.
Check the pulse oximeter sensor application site frequently to determine the positioning of the sensor and circulation
5
and skin sensitivity of the patient.
Do not stretch the adhesive tape while applying the pulse oximeter sensor. This may cause inaccurate readings or skin
6
blisters.
Before use, carefully read the manual.
7
The pulse oximeter has no SpO alarms; it is not for continuous monitoring.
8
2
Prolonged use or the patient's condition may require changing the sensor site periodically. Change sensor site and
9
check skin integrity, circulatory status, and correct alignment at least every 4 hours.
Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid.
10
Significant levels of dysfunctional hemoglobins (such as carbonxy- hemoglobin or methemoglobin) may affect the
11
readings.
Intravascular dyes such as indocyanine green or methylene blue
12
SpO measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a
13
2
surgical towel, or direct sunlight, for example) if necessary.
Excessive patient movement may cause inaccurate readings.
14
High-frequency electrosurgical interference may cause inaccurate readings.
15
Venous pulsations may cause inaccurate readings.
16
Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
17
The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
18
The patient is in cardiac arrest or is in shock.
19
Fingernail polish or false fingernails may cause inaccurate SpO
20
Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device
components, including batteries.
Product Properties
1 Operation of the product is simple and convenient.
2 The product is small in volume, light in weight and convenient in carrying.
3 Power consumption of the product is low and the two AAA batteries can be operated continuously for 30 hours.
4 A low voltage warning will be indicated in visual window when battery voltage is so low that normal operation of the
oximeter might be influenced.
5 The product will automatically be powered off when no signal is in the product for longer than 8 seconds.
Product Operation Scope
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO
pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive
care etc). It is not for continuously monitoring.
The PULSE OXIMETER requires no routine calibration or maintenance other than replacement of batteries.
Operation Instructions
1 Install two AAA batteries into battery cassette before closing its cover.
2 Place clamp over finger nail as the following diagram.
3 Insert one finger into rubber hole of the Oximeter fully.
4 Press the switch for one time on front panel.
5 Finger and body should not tremble during measuring.
6 Read corresponding data on the display screen.
Note: Please use medical alcohol to clean the rubber, inside the Oximeter, that touches the finger. Also, clean the test finger
with alcohol before and after each test. (The rubber inside of the Oximeter is medical rubber, which has no toxins, and is not
harmful to the skin).
When your finger is inserted into the Oximeter, your nail surface must be upward.
Operation Instructions
The Pulse bar graph displays corresponding with the patient's pulse beat. The height of the bar graph shows the patient's
pulse strength.
Product Accessories
1. One strap
2. Two AAA batteries
3. One user's manual
Battery Installation
1. Put the two AAA batteries into battery compartment in correct polarities.
2. Push the battery cover horizontally along the arrow shown as below:
Notes:
Battery polarities should be correctly installed. Otherwise, damage may be caused
to the device.
Please put in or remove batteries in right order, or may cause damage to the device
bracket.
Please remove the batteries if the Oximeter will not be used for a long time.
MD300C1
readings.
2
) and
2
Strap Installation
1. Thread thinner end of the strap through the loop.
2. Thread thicker end of the strap through the threaded end before pulling it tightly.
Calibrating the pulse oximeter
1. The functional tester cannot be used to assess the accuracy of the oximeter.
2. The test methods used to establish the SpO
haemoglobin oxygen saturation levels and these levels are to be compared to the levels determined from arterial
blood sampling with a CO-oximeter.
3. Index 2 made by Bioteck company is a function tester. Set Tech to 1, R curve to 2, then user can use this particular
calibration curve to measure the oximeter.
Maintenance and Storage
1. Replace the batteries in time 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 inside the battery cassette if the Oximeter will not be operated for a long time.
4. It is best to preserve the product in a place where ambient temperatures is -20℃～55℃(-4～131℉) and relative
humidity is ≤93%.
5. It is recommended that the product should be kept in a dry environment anytime. A wet ambient might affect its lifetime
and even might damage the product.
6. Please follow the law of the local government to deal with used battery.
Detailed descriptions of product functions
1. Display Type: LED
2. SpO :
2
Measurement range: 70-99%
Accuracy: 80%-99%, ±2%; 70%-80%,±3%; ≤69% no definition.
3. Pulse Rate:
Measure range: 30-235 BPM
Accuracy: 30~99bpm, ±2bpm; 100~235bpm, ±2%
Pulse Intensity: Bargraph Indicator
4. Power Requirements:
Two AAA alkaline Batteries
Power consumption: Less than 40mA
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated as long as 30 hours.
5. Dimension:
Length: 56mm～62mm
Width: 32mm～38mm
Height: 34mm～38mm
Weight: 45g～60g (including two AAA batteries)
6. Environment Requirements:
Operation Temperature: 5～40℃
Storage Temperature: -20～55℃
Ambient Humidity: ≤80%, no condensation in operation.
≤93%, no condensation in storage
7. Measurement Performance in Low Perfusion Condition: required the test equipment (BIO-TEK INDEX Pulse Oximeter
tester) the pulse wave is available without failure when the simulation pulse wave amplitude is at 6%.
8. Interference Resistance Capacity against Ambient Light: Device works normally when mixed noise produced by
BIO-TEK INDEX Pulse Oximeter tester.
Declaration
EMC of this product complies with IEC60601-1-2 standard.
The materials which the user can come into contact have no toxicity and no action on tissues comply with ISO10993-1,
ISO10993-5 and ISO10993-10.
Guidance and manufacturer's declaration – electromagnetic emissions-for all EQUIPMENT and
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
the Pulse Oximeter should assure that it is used in such an environment.
Emission test Compliance
The Pulse Oximeter uses RF energy only for its internal function. Therefore, its RF
RF emissions Group 1
emissions are very low and are not likely to cause any interference in nearby
CISPR 11
electronic equipment.
RF emission Class B
The Pulse Oximeter is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply.
CISPR 11
network that supplies buildings used for domestic purposes.
Possible Problems and resolutions
Problems Possible reason
1. Finger is not inserted correctly
SpO or PR
2
2. Patient's Oxyhemoglobin value is too low to be
can not be
measured
shown
normally
1. Finger might not be inserted deep enough.
SpO or PR is
2
2. Finger is trembling or patient's body is in movement
shown
status.
unstably
1. Power of batteries might be inadequate or not be
The Oximeter
there at all
can not be
2. Batteries might be installed incorrectly
powered on
3. The Oximeter might be damaged
1. The product is automatically powered off when no
Indication
signal is detected longer than 8 seconds
lamps are
2. Power quantity of the batteries is started being
suddenly off
inadequate
1. Low power
"Error3" or
2. Receiving tube being shielded or damaged together
"Error4" is
with broken connector.
displayed on
3. Mechanical Misplace for receive-emission tube
screen
4. Amp circuit malfunctions.
"Error7" is 1. Low power
displayed on 2. Emission tube damaged.
screen 3. Current control circuit malfunctions.
Symbol Definitions
Symbol Definition
Type BF applied part.
Attention, consult accompanying documents.
﹪SpO Arterial Oxygen saturation
2
Pulse rate (BPM)
Low power indication
No SpO Alarm
2
Power switch
SN
Serial No.
Note：The illustration used in this manual may differ slightly from the appearance of the actual product.
accuracy is clinical testing. The oximeter used to measure the arterial
2
SYSTEMS
Electromagnetic environment – guidance
Solution
1.Retry by inserting the finger
2. Try some more times, If you can make sure no
problem is existing in the product. Please go to a
hospital timely for exact diagnosis.
1. Retry by inserting the finger
2. Try not to move
1. Please replace batteries
2. Please reinstall the batteries
3. Please contact with local customer service centre
1. Normal
2. Replace the batteries
1. Change batteries
2. Please contact local customer service center
3. Please contact local customer service center
4 Please contact local customer service center
1 Please change battery
2 Please contact local customer service center
3 Please contact local customer service center
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