Little Doctor MD300C23 User manual

INSTRUCTION MANUAL
Fingertip Pulse Oximeter model MD300C23
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 Posto-
perative 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 oxy-
gen 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.
PARTS LIST
Complete set (fig. 1):
Main Unit – 1 pcs.,
Instruction Manual with Warranty Card – 1 pcs.,
Hang Lace – 1 pcs.,
batteries – 2 pcs.
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 is Photoelectric Oxyhemoglobin Inspection Technology is adopted in accor-
dance 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 OLED
display through process in electronic circuits and microprocessor.
Diagram of Operation Principle
1. 1.Red and Infrared-ray Receipt Tube.
2. 1.Red and Infrared-ray Emission Tube. (fig.2)
INTENDED USE
The Fingertip Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation
of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type
facilities and homecare.
PRECAUTIONS FOR USE
1. Before use, carefully read the manual.
2. Operation of the pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
3. The pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify
that nothing is hindering the pulse measurement before relying on the SpO2 measurement.
4. Do not use the pulse oximeter in an MRI or CT environment.
5. Do not use the pulse oximeter in situations where alarms are required. The device has no alarms. It is not for
continuous monitoring.
6. Do not use the pulse oximeter in an explosive atmosphere.
7. 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.
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 com-
ponents, including batteries.
11. This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for medical electrical equ-
ipment 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. The portable and
mobile RF communications equipment should be used no closer than 30cm (12 inches) to any part of the device,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
13. This equipment is not intended for use during patient transport outside the healthcare facility.
14. The patient is an intended operator. All functions of the device can be safely used.
15. 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
16. The material that contact with the patient’s skin has passed the ISO10993-5 Tests for invitro cytotoxicity and
ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
17. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
18. The use of accessories, transducers and cables other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.
19. When the signal is not stable, the reading may be inaccurate. Please do not refer to the measurement.
20. The material of the device has no nature latex.
21. The pulse oximeter equipment is calibrated to display functional oxygen saturation.
22. The waveform we provide is normalized.
Rx only: „Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.”
BATTERY INSTALLATION
1. Shift the bottom panel and then open it (fig.3a).
2. Put the two AAA batteries into battery cassette
in correct polarities (fig. 3b).
3. Close the bottom panel (fig. 3c).
WARNING!
Replace batteries when low power indncator “ ” is lit or if after pressing Power button there is no indica-
tion on display.
Please remove the battery if the Oximeter will not be used for a long time.
Do not use re-chargable batteries.
HOW TO USE
WARNING! Do not tremble the hand with oximeter during measuremrnt
1. Open the clamp (fig. 4)
2. Plug one of fingers into rubber hole of the oximeter (it is best to plug the finger
thoroughly) before releasing the clamp.
3. Press the button once on front panel.
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
SpO 2%
PR bpm
95 84
2
SpO 2%
PR bpm
97 74
3
SpO 2%
PR bpm
98
77
4
SpO 2%
PR bpm
98
77
5
SpO 2%
PR bpm
97 77
6
SpO 2%
PR bpm
97 74
4. Read correspondent data from display screen:
SpO 2%
PR bpm
97 74
Low power indicator
Pulse Wave
SpO 2%
PR bpm
95
84
PR signal
intensity Bar
graph
PR
SpO 2
BRIGHTNESS ADJUSTMENT
When you press the power switch for a long time (more than one second), the brightness of the oximeter will
be changed by degrees, there are 10 levels on brightness; the default level is level four.
HANG LACE INSTALLATION
1. Thread thinner end of the hang lace through the hanging hole (fig. 5).
2. Thread thicker and of the lace through the threaded end before pulling it tightly.
MAINTENANCE AND STORAGE
Replace the batteries timely when indncator “ ” is lit.
Clean surface of the fingertip oximeter before it is used in diagnosis for patients
Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time.
It is best to preserve the product in a place where ambient temperatures -20-55r and humidity is <93%.
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.
Please follow the law of the local govern ment to deal with used battery.
SPECIFICATION
Model MD300C23
Display OLED display
SpO2
measurement range
accuracy
70% - 100%
±2%
Pulse Rate
measurement range
accuracy
30 - 250 bpm
30 - 99 bpm - ±2 bpm;
100 - 250 bpm - ±2%
Measurement wavelengths
red
infrared
660 nm
905 nm
Power source 2 x 1,5V AAA (LR03)
Battery set operating period > 30 hrs.
Max. power consumption 0.075 W
Applicable finger circumference 20-75 mm
Fig. 5
Fig. 4
Fig. 2
1
2
Fig. 1
Fig. 3a Fig. 3b Fig. 3c
ENG

®Registered trade marks of Little Doctor International (S) Pte. Ltd.
© Little Doctor International (S) Pte. Ltd., 2021
Operating conditions :
Temperature
Relative humidity
5ºС ~ 40ºС
<80%
Storage and transportation environment :
Temperature
Relative humidity
-20 ºС ~ 55ºС
< 93%
Net Weight (without batteries) 31g
External dimension 58 (L) х 30 (W) х 34 (H) mm.
Date of manufacturing Manufacturing Date printed on sticker
Country of Origin PRC
Symbol Definitions:
SYMBOL DEFINITION SYMBOL DEFINITION
Type BF applied part. Conformity to WEEE Directive
IP22 Protected against dripping water. Attention
PR bpm Pulse rate (BPM) %SpO2 Oxygen saturation
No SpO2 Alarm Low power indication
Storage temperature and relative
humidity Serial No.
Date of Manufacture Follow instructions for use
European Union approval Authorized representative in the
European community
Sign of type approval of measuring
instruments Manufacturer’s information
DECLARATION
This device complies with EMC (IEC 60601-1-2:2001, CISPR 11/A2:2002
(Group 1, Class B), IEC 61000-4-2:2001, IEC 61000-4-3:2002, IEC 61000-4-8:2001).
The materials which user can come into contact have no toxicity and no action on tissues, complying with ISO10993-
1,-5,-10.
Manufactured under control and for Little Doctor International (S) Pte. Ltd., 7500A, Beach Road, 11-313 The Plaza
199591, Singapore. Yishun Central P.O. Box 9293 Singapore 917699.
Manufacturer: Beijing Choice Electronic Technology Co., Ltd. (Room 4104, №.A12 Yuquan Road, Haidian District,
100143 Beijing, PRC).
Distributor in Europe: Little Doctor Europe Sp. z o.o., 57G Zawila Street, 30-390, Kraków, Poland
Sales Office phone: [phone], fax: [phone]
E-mail: [e-mail]
www.LittleDoctor.pl
GUARANTEE
We grant 2 years guarantee on the product commencing on the date purchase. The guarantee only comes info force
if the data of purchase is confirmed by the dealer’s stamp and signature on Guarantee Card.
This warranty does not extend to, and will be void in respect of any products which have been subjected to misuse,
neglect, fire, improper modification, use in violation of the instructions furnished by us repaired by an unauthorized
third party.
TROUBLESHOUTING
Problems Possible reason Solution
SpO2 or
PR can not
be shown
normally
1. Finger is not plugged
correctly
2. Patient’s Oxyhemoglobin
value is too low to be measured
1. Retry by plugging the finger
2. Measure other patients to make sure that no problem
exists in the product. Go to a hospital in a timely manner
for an exact diagnosis.
SpO2 or PR
is shown
unstably
1. Finger might not be plugged
deep enough
2. Finger is trembling or
patient’s body is in movement
status
1. Retry by plugging the finger
2. Try not to move
The Oximeter
can not be
powered on
1. Power of batteries might be
inadequate or not be there
at all
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. Power is too low.
1. Normal
2. Replace the batteries
E595/2111/4_ENG
MD300C23
Name and address of retailer
Serial №MODEL
Date of Purchase Purchaser sign
I confirm that surface appearance
and complete set of device is OK:
Retailer stamp
Purchaser sign
GUARANTEE CARD
For more information please visit
WWW.LITTLEDOCTOR.SG
LITTLE DOCTOR INTERNATIONAL (S) PTE. LTD.
Yishun Central P.O. Box 9293 Singapore 917699,
Fax: [phone], E-mail: [e-mail]
EC-Rep: Shanghai International Holding Gorp. GmbH (Europe).
Eiffestrasse 80, 20537 Hamburg, Germany.
Beijing Choice Electronic Technology Co., Ltd.,
Room 4104, №.A12 Yuquan Road, Haidian District,
100143 Beijing, PRC
“Error3” or
“Error4”
Displayed on
screen
1 .Low power
2. Receiving tube being
shielded or damaged together
with broken connector.
3. Mechanical Misplace for
receive-emission tube
4. Amp circuit is malfunction.
1. Change new battery
2. Please contact with local customer service center
3. Please contact with local customer service center
4 Please contact with local customer service center
“Error7”
displayed on
screen
1. Low power
2. Emission tube damaged.
3. Current control circuit is
malfunction.
1 Change battery
2 Contact with local customer service center
3 Contact with local customer service center
ELECTROMAGNETIC COMPATIBILITY
The device conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard.
Essential performance is defined as SpO2 accuracy and pulse rate accuracy or an indication of abnormal operation.
Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environ-
ments listed in the intended use. If issues are experienced, move the device away from the source of electromagne-
tic disturbances.
TABLE 1: ELECTROMAGNETIC EMISSIONS LIMITS AND COMPLIANCE
Emissions Test Compliance
RF Emissions
CISPR 11 Group 1, Class B
Note: Harmonic Emissions (IEC 61000-3-2), Voltage Flicker Emissions (IEC 61000-3-3) are not applicable.
TABLE 2: ELECTROMAGNETIC IMMUNITY
Immunity Test Compliance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Rated power Frequency Magnetic Fields
IEC 61000-4-8
30 A/m
50Hz and 60 Hz
Radiated RF
IEC 61000-4-3
80 MHz – 2.7 GHz 10 V/m 80% AM 1kHz
380 – 390 MHz 27 V/m Pulse mod. 18Hz
430 – 470 MHz 28 V/m FM±5Hz deviation 1kHz sine
704 – 787 MHz 9 V/m Pulse mod. 217Hz
800 – 960 MHz 28 V/m Pulse mod. 18Hz
1.7 – 1.99 GHz 28 V/m Pulse mod. 217Hz
2.4 – 2.57 GHz 28 V/m Pulse mod. 217Hz
5.1 – 5.8 GHz 9 V/m Pulse mod. 217Hz
Note: Electrical Fast Transients (IEC 61000-4-4), Surge (IEC 61000-4-5), Voltage dips (IEC 61000-4-11),
Conducted Immunity (IEC 61000-4-6) are not applicable.