Beijing Choice Electronic Technology MD300C22 User manual

OPERATOR'S
MANUAL
( E0123
I MD300C2i
V3.0C2
Fingertip Pulse Oximeter
General Description '.-:-'. .
Oxygen Saturation is a percentage of Oxyhemoglobin (Hb02) 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 (Hb02) 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 rnfrared-ray Receipt Tube
Precautions for use
Do not use the pulse oximeter in an MRI or CT environment
2 Do not use the pulse oximeter in situations where alarms are required. The device
has no alarms.
3 Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
4 The pulse oximeter is intended only as an adjunct in patient assessment. It must be
used in conjunction with other methods of assessinq clinical signs and symptoms.
5 Check the pulse oximeter sensor application site frequently to determine the
positioning of the sensor and circulation and skin sensitivity of the patient.
6' Do not stretch the adhesive tape while applying the pulse oximeter sensor. This may
cause inaccurate readings or skin blisters.
7 Before use, carefully read the manual.
8 The pulse oximeter has no Sp02 alarms; it is not for continuous monitoring.
9 Prolonged use or the patient's condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours.
10 Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing,
or immersing the sensors in liquid.
11 Significant levels of dysfunctional hemoglobins (such as carbonxy- hemoglobin or
methemoglobin) may cause inaccurate readings.
12 Intravascular dyes such as indocyanine green or methylene blue.
13 Sp02 measurements may be adversely affected in the presence of high ambient light.
Shield the sensor area (with a surgical towel, or direct sunlight, for example) if
necessary.
14 Excessive patient movement may cause inaccurate readings.
15 Venous pulsations may cause inaccurate readings.
16 High-frequency electrosurgical interference may cause inaccurate readings.
17 Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
18 The patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia.
19 The patient is in cardiac arrest or is in shock.
20 Fingernail polish or false fingernails may cause inaccurate Sp02 readings.
Follow local ordinances and recycling instructions regarding disposal or
recycling of the device and device components, including batteries.
Product Properties
Operation of the product is simple and convenient
The product is small in volume, light in weight and convenient in carrying.
Power consumption of the product is low and the two AAA batteries can be
operated continuously for 30 hours.
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.
1
2
3
4
Product Operation Scope
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check, oxygen saturation
of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patient at home, and
hospital (including clinical use in intemisUsurgery, 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 compartment correctly.
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 once on the front panel.
5 Finger and body should not tremble duringl'lleasuring.
6 Read correspondent data from display screen.
7Six 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:
seo PR
SpO_ SpO,
PR_
95 84 97 74 198
I.
--
2.
~3.
'Ild
'OdS
PR
SpO,
'tld
L6
1
-...j
(,0
«:t
-...j
I'-
4. 5. 6.
When you press and hold the power switch for more than one second, the brightness of
the oximeter will be changed by degrees, there are 10 levels on brightness; the default
is level four.
NOTE: Please use medical alcohol to clean the rubber touching the finger inside of
Oximeter, and clean the test finger using alcohol before and after each test. (The rubber
inside of the Oximeter belongs medical rubber, which has no toxin and no harmful to the
skin).
When your finger is inserted into the Oximeter, your nail surface
must be upward.
Brief Description of Front Panel
Pulse bar graph
sp<n% Waw/oml P~ Swi1dl
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.
2.
3.
One strap
Two batteries
One user's manual
Battery Installation
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
installed. Otherwise, damage
caused to the device.
Please put in or remove batteries in right
order, or may cause damage to the device
bracket.
correctly
may be
Please remove the batteries if the Oximeter
will not be used for a long time.

Strap Installation Possible Problems and resolutions
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. Problems
SpO,orPR
can not be
shown
normally
Possible reason
1. Finger is not inserted correctly
2. Patient's Oxyhemoglobin value is
too low to be measured
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.
Retry by inserting the finger
Try not to move
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, accuracy is clinical testing. The
oximeter used to measure the arterial 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.
1. Finger might not be inserted deep 1
enough. 2
2 Finger is trembling or patient's
body is in movement statu .
1. Power of batteries might be
inadequate or not be there at all
2. Batteries might be installed
incorrectly
3. The Oximeter "2 ght be damaged
1. The product is automatically 1 Normal
powered off when no signal is 2. Replace the batteries
detected longer than 8 seconds
2. Power quantity of the battenes is
started being inadequate
1 .Low power
2. Receiving tube being shielded or
damaged together with broken
connector.
3. Mechanical Misplace for
receive-emission tube
4. Amp circuit malfunctions.
SpO, or PR IS
shown
unstably
1 Please replace batteries
2. Please reinstall the batteries
3. Please contact with local
customer service centre
The OXimeter
can not be
powered on
Maintenance and Storage
Indication
lamps are
suddenly off
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
'C-55'C(-4-131'1') 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.
1 Change battenes
2. Please contact local customer
service center
3. Please contact local customer
service center
4 Please contact local
customer service center
"Error3" or
"Error4" is
displayed on
screen
"Error?" is
displayed on
screen
1. Low power
2. Emission tube damaged.
3. Current control Circuit
malfunctions.
Please change battery
""-.:i!: PI tact local
customer service center
3 Please contact local
customer service center
Detailed descriptions of product functions
1. Display Type: OLEO
2.SpO,:
Measurement range: 70-99%
Accuracy: 80%-99%, ±2%; 70%-80%,±3%; ~69% no definition.
Symbol Definitions
Symbol Definition
3. Pulse Rate:
Measure range, 30-235 BPM
Accuracy, 30-99bpm, ±2bpm; 100-235bpm, ±2%
Pulse Intensity: Bargraph Indicator Type BF applied part.
Attention, consult accompanying documents.
4. Power ReqUirements:
Two AAA alkaline Batteries
Power consumption: Less than 40mA Oxygen saturation
•
(JP
Heart rate (BPM)
Low powet-illdication:
Battery life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated
as long as 30 hours. Low power indication
~
pOa
Not for continuous monitoring
5. Dimension:
Length: 56mm-62mm
Width: 32mm-38mm
Height: 34mm-38mm
Weight: 45g-60g (including two AAA batteries)
S
Serial No.
Applicable models
6. Environment Requirements:
Operation Temperature: 5-40'C
Storage Temperature: -20-55'C
Ambient Humidity: ~80%, no condensation in operation.
~93%, no condensation in storage
MD300C2 MD300C203 MD300C204 MD300C21 MD300C21C MD300C21-P
MD300C22 MD300C23 MD300C24 MD300C25 MD300C26 MD300C28
MD300C29 MD300C20 MD300C2A MD300C2B MD300C2D MD300C2E
7. Measurement Performance In Low Perfusion Condition: required the test
equipmen (BIO-TEK IN EX Pulse Oximeter tester) the pulse wave is available wit out
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.
Note, The illustration used In this manual may differ slightly from the appearance
of the actual product.
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 IS010993-1 , IS010993-5 and IS010993-10.
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 the Pulse Oximeter should assure that it is used
in such an environment.
Emission test
RF emissions
CISPR 11
Compliance
Group 1
Electromagnetic environment - guidance
The Pulse Oximeter uses RF energy only for its
intemal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
The Pulse Oximeter 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.
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RF emission
CISPR 11 Class B
ALL RIGHTS RESERVED
Issue date: 221February2010