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  9. Beijing Choice Electronic Technology Fingertip Pulse Oximeter User manual

Beijing Choice Electronic Technology Fingertip Pulse Oximeter User manual

OPERATOR'S
MANUAL C E0
1
23
V4.00I
Fingertip Pulse Oximeter

MD300CI
Gen
era
l
D
esc
r
iption
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
.
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 tight) 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
I
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 assessing 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 Sp0
2
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 affect the 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 High-frequency electrosurgical interference may cause inaccurate readings.
16
Venous pulsations 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 Sp0
2
readings.
Follow local ordinances and recycling instructions regarding disposal or
recycling of the device and device components, including batteries.
-
Produ
ct
ra
Pro
p
er
ties
1

Operation of the product is simple and convenient.
2

The product is small in volume, tight 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
lO
peration
S
c
op
e
Fingertip PULSE OXIMETER is a portable non-invasive, spot-check, oxygen saturation
of arterial hemoglobin
(SPO2)
and 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.
Power Swrlch
Pulse us' graph

Oxygen Saturat~on
Pulse Rate
The Pulse bar graph displays corresponding with the patient's pulse beat. The height of
the bar graph shows the patient's pulse strength.
1.
One strap
2.
Two batteries
3.
One user's manual
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:
O
Battery polarities should be correctly installed.
Otherwise, damage may be caused to the
device.
4-
Please put in or remove batteries in right
order, or may cause damage to the device
bracket.
.
4-
Please remove the batteries if the Oximeter
will not be used for a long time.
-
ni rnrnrrti
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
,
1.

The functional tester cannot be used to assess the accuracy of the oximeter
2.
The test methods used to establish the
5P°2
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 function tester. Set Tech to 1, R curve 102,
then user can use this particular calibration curve to measure the oximeter.
The Oximeter
1.
Power of batteries might be
can not be
inadequate or not be there at all
powered on
2.
Batteries might be installed
incorrectly
3.
The Odrneter mig)) be damaged
Indication
1. The product is automatically
lamps are
powered off

when no signal is
suddenly off
detected longer than 8 seconds
2 Power quantity of the batteries is
started being inadequate
Error3'

or
1.
Low power
"Error4" is
2.
Receiving tube being shielded or
displayed on
damaged together with broken
screen
connector.
3.
Mechanical Misplace for
receive-emission tube
4.
Amp circuit malfunctions.
Error7' is
1.
Low power
displayed on
2.
Emission tube damaged.
screen
3.
Current control circuit
malfunctions.
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
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
t-55t(4---131I') and relative humidity is n93%.
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.
Display Type: LED
2.
Sp0
2
:
Measurement range: 70-99%
Accuracy. 80%-99%. ±2
0
%; 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 AA) alkaline Batteries
Power consumption: Less than 40mA
Low power indication:
LIZIP
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---40C
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
equpment (B(O-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 BlO-TEK INDEX Pulse Oximeter tester.
Symbol

Definition
Type BF applied part.
Attention, consult accompanying documents.
% Sp02

Oxygen saturation
BPM

Heart rate (BPM)
IIZII

Low power indication
No Sp0
2
Alarm
Power switch
SN

Serial No.
Applicable m
MD300C1

MD300C1C MD300C12 MD300C12-P MD300013 MD300014
MD300C1-E MD300C15 MD300C16 MD300C17 MD300C18 MD300C19
MD300C10 MD300C1A MD300C16 MD300C1D MD300C1E
Note: The illustration used in this manual may differ slightly from the appearance
of the actual product.
EMC of this product complies with 1EC60601-1-2 standard
The materials which the user can come into contact have no toxicity and no action on
tissues comply with 15010993-1, 1S010993-5 and lSO10993-10.
Guidance and manufacturer's declaration - electromagnetic emission
The
Pulse Ox/meter
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

Electromagnetic environment - guidance
RF emissions

Group 1

The
Pulse Oximeter
uses RE energy only for its
CISPR 11

internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emission

Class B

The
Pulse Ox/meter
is suitable for use in all
CISPR 11

establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply. network
that supplies buildings used for domestic
purposes.
Possible
Problems
,t-ii
and

I7rTTh..
Possible reason
Solution
Sp0
2
or PR
1.
Finger is not inserted correctly
1
.Retry by inserting the finger
can not be
2.
Patient's Oxyhemoglobin value is

2. Try some more times, If you
shown
too low to be measured
can make sure no problem is
normally
existing in the product.
Please go to a hospital timely
for exact diagnosis.
Sp0
2
or PR is
1.
Finger might not be inserted deep

1. Retry by inserting the finger
shown
enough.
2. Try not to move
unstably
2.
Finger is trembling or patient's
body is in movement status.
S
Be
,
iing Choice Eiecfron,c Technoiogy Co. Lid
Blcngycan81127-1128.Fcei'g R.A36
100039 hepng
PEOPLE'S REPUBLIC Of CHINA
Em-t-13. 80,20537
EC REP
Ho,nbcrg GERMANY
Shanghai internatIonal
Raiding Coip.Gnlb$-4(Edrop,.)

'
ALL RIGHTS RESERVED
Issue date: 25/February 2010

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