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: IPX22
According to the mode of operation: CONTINUOUS OPERATION
Clinical Study Summary
The following details are provided to disclose actual performance observed in the clinical validation study of healthy adult
volunteers. The ARMS value analysis statement and Bland-Altman plot of data is shown as following:
ARMS Value Analysis Statement
Item
90--100
80--<90
70--<80
#pts 78
66
63
Bias 1.02
0.40
-0.48
ARMS 1.66
1.46
1.93
Bland-Altman Plot Graphic
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 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 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
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 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 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, 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 survey
a
, 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.
a Field 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 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.
b Over 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
The
Pulse Oximeter
is intended for use in electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the
Pulse Oximeter
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Pulse Oximeter
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
SpO
2
or PR can not
be shown normally
1. Finger is not inserted correctly
2. Patient’s SpO
2
value 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.
SpO
2
or 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
“Error7” is displayed
on screen
Err 7 means all the emission LED or reception diode is
damaged.
Please contact with local customer service centre
Symbol Definitions
Symbol
Definition
Symbol
Definition
Type BF applied part.
Attention
IP22
Protected against dripping water.
﹪
SpO
2
Oxygen saturation
PR
bpm
Pulse rate (BPM)
Low power indication
No SpO
2
Alarm
SN
Serial No.
Storage temperature and relative
humidity
Follow instruction for use
Date of Manufacture
Authorized representative in the European
community
European union approval
Manufacturer’s information
Conformity to WEEE Directive
Box Contents
1.
Fingertip pulse oximeter
2. One
lanyard
3. Two
AAA
batteries
4.
One instruction manual
Applicable Models
MD300C2 MD300C21 MD300C21C MD300C22 MD300C23 MD300C25 MD300C26 MD300C29 MD300C2A
MD300C2B MD300C2D MD300C2E MD300C2F MD300C2G MD300C2H MD300C2I MD300C203 MD300C21-P
Pay attention:
Only the device of MD300C203 is single-color OLED screen.
Only the device of MD300C21-P has the feature of automatically power on.
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: March 2, 2017
Version: Ver1.0