D.SPEC.05.

14 Pulse oxymètre MD300-C15D - Mode d'emploi_EN

Fingertip Puls Oximeter

MD300 C15D
User manual

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Thank you for choosing an Oxycure concentrator.

The Oxycure range, from left to right

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More information at www.oxycure.be

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OXYCURE : ORDERS 081 22 15 90

Oxycure Belgium plc.
Business Park Fernelmont
L. Génicot, 9
B-5380 Fernelmont
Belgium
Tel + 32 (0)81 22 15 90
Fax + 32 (0)81 22 15 99

http://www.oxycure.be
e-mail : [email protected]

OPENING HOURS
From Monday to Friday 09.00 – 12.30 and 13.30 – 18.00

CUSTOMER SERVICE 0800 98 0 68

Our customer service operates 24/7.

It is exclusively to urgent installations or repairs on our medical devices.

Call to guard service

 Leave a message on the answering machine with your name and phone number and give a
brief reason of your call ;
 The customer service will call you within 20 minutes ;
 If the customer service did not call you within 20 minutes, call again.

Notes
1. Technical interventions (repairs) are included in the price of the assistance of the leasing.
2. Deliveries of goods, outside the opening hours, will be charged.

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Fingertip MD300 C15D

Pulse Oximeter
USER MANUAL
Ver3.0C1/C4
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 low power consumption, convenient operation and portability.
Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen
saturation will appear on the display. 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 red 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
red and 905nm 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.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
Precautions For Use
1. Before use, carefully read the manual.
2. Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit
(ESU).
3. The fingertip 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 fingertip pulse oximeter in an MRI or CT environment.
5. Do not use the fingertip pulse oximeter in situations where alarms are required. The device has
no alarms. It is not for continuous monitoring.
6. Do not use the fingertip pulse oximeter in an explosive atmosphere.
7. The fingertip 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
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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 components, including batteries.
11. This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility for medical
electrical equipment 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.
13. This equipment is not intended for use during patient transport outside the healthcare facility.
14. This equipment should not be used adjacent to or stacked with other equipment.
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. These materials that contact with the patient’s skin contain medical silicone and ABS plastic
enclosure are all pass the ISO10993-5 Tests for invitro cytotoxicity and ISO10993-10 Tests for
irritation and delayed-type hypersensitivity.
Rx only: “Caution: Federal law (USA) restricts this device to sale by or on the order of a
licensed practitioner.”
Contraindication
It is not for continuous monitoring.
Inaccurate measurements may be caused by
1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or
methemoglobin).
2. Intravascular dyes such as indocyanine green or methylene blue.
3. High ambient light. Shield the sensor area if necessary.
4. Excessive patient movement.
5. High-frequency electrosurgical interference and defibrillators.
6. Venous pulsations.
7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9. The patient is in cardiac arrest or is in shock.
10. Fingernail polish or false fingernails.
11. Weak pulse quality (low perfusion).
12. Low hemoglobin.
Product Features
1 High brightness LED/LCD display SpO2, PR, and Pulse bar.
2 Two display modes. (NOTE: except for LCD series)
3 2 pcs AAA-size alkaline batteries; battery-low indicator.
4 When no operation or low signal is detected, the pulse oximeter will power off automatically in
8 seconds.
Intended Use
Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals,
hospital-type facilities.
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Operation Instructions
1． Install two AAA batteries according to the Battery Installation instructions.
2． Place one of your fingers into the rubber opening of the pulse oximeter.
3． Press the switch button one time on front panel to turn the pulse oximeter on.
4． Keep your hands still for the reading. Do not shake your finger during the test. It is
recommended that you do not move your body while taking a reading.
5． Read the data from the display screen. There are two display modes. After turning on the pulse
oximeter, each time you press the power switch, the pulse oximeter will switch to another
display modes. (NOTE: only for the MD300C4 series)

Front Panel
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2 and pulse rate
value is potentially incorrect.

Battery Installation
1. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs
in the compartment. If the polarities are not matched, damage may be caused to the oximeter.
2. Slide the battery door cover horizontally along the arrow shown as the picture.
Note:
 Please remove the batteries if the pulse oximeter will not be used for long periods of time.
 Please replace the battery when the power indicator starting flickering.

Using the Lanyard

1. Thread thinner end of the lanyard through the loop.
2. Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
 Keep the oximeter away from young children. Small items such as the battery door, battery, and
lanyard are choking hazards.
 Do not hang the lanyard from the device’s electrical wire.
 Please notice that the lanyard which is tied to the oximeter may cause strangulation due to
excessive length.
Maintenance and Storage
1. Replace the batteries in a timely manner when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for patients.
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3. Remove the batteries if the oximeter is not operated for a long time.
4. It is best to store the product in -20℃～+55℃ and ≤93% humidity.
5. Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.
6. Dispose of battery properly; follow any applicable local battery disposal laws.
Cleaning the fingertip pulse oximeter
Please use medical alcohol to clean the silicone touching the finger inside of oximeter with a soft
cloth dampened with 70% isopropyl alcohol. Also clean the being tested finger using alcohol before
and after each test.
Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in
the device. Allow the oximeter to dry thoroughly before reuse.
The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement
of batteries.
The use life of the device is five years when it is used for 15 measurements every day
and 10 minutes per one measurement. Stop using and contact local service center if
one of the following cases occurs:
 An error in the Possible Problems and solutions is displayed on screen.
 The oximeter cannot be powered on in any case and not the reasons of battery.
 There is a crack on the oximeter or damage on the display resulting readings cannot be identified;
the spring is invalid; or the key is unresponsive or unavailable.
Specifications
1. Display Type
LED display
2. SpO2
Display range: 0%~100%
Measurement range: 70%~100%
Accuracy: 70%~100%±2digits; 0%~69% no definition
Resolution: 1%
ARMS Value Analysis
Item 70--100 90--100 80--<90 70--<80
#pts 231 82 89 60
Bias 1.10 0.49 1.35 1.62
ARMS 1.68 1.09 1.77 2.14
Bland-Altman plot analysis of sampled data points on all subjects as below

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
Clinical testing is used to establish the SpO2 accuracy. The measured arterial hemoglobin saturation
value (SpO2) of the sensors is compared to arterial hemoglobin oxygen (SaO2) value, determined
from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to
the CO-oximeter samples measured over the SpO2 range of 70%~100%. Accuracy data is
calculated using the root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical
Electrical Equipment–Particular requirements for the basic safety and essential performance of
pulse oximeter equipment for medical use.
A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the
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specified calibration curve and the PR accuracy.

The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3.
3. Pulse Rate
Display range: 0bpm~250bpm
Measure range: 30bpm~250bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~250bpm, ±2%
Resolution: 1bpm
4. Probe LED Specifications
Wavelength Radiant Power
RED 660±2nm 3.2mW
IR 905±10nm 2.4mW
NOTE: The information about wavelength range can be especially useful to clinicians.
5. Power Requirements
Two AAA alkaline Batteries
Power consumption: Less than 25mA
Battery Life: Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as
16 hours.
6. Environment Requirements
Operation Temperature: 5℃～40℃
Storage/ Transport Temperature: -20℃～+55℃
Ambient Humidity: ≤80% no condensation in operation; ≤93% no condensation in
storage/transport
Atmosphere pressure: 86kPa～106kPa
7. Equipment data update period
As shown in the following figure. Data update period of slower average is 12.4s.

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: IPX1
According to the mode of operation: CONTINUOUS OPERATION
Declaration
Guidance and Manufacturer’s declaration – electromagnetic emissions-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic emission
The MD300C1 Pulse Oximeter is intended for use in the electromagnetic environment specified
below. The customer or the user of MD300C1 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 MD300C1 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

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electronic equipment.
RF emissions CISPR 11 Class B The pulse Oximeter (MD300C1) is suitable for use in all
Harmonic emissions Not establishments, including domestic establishments and
IEC 61000-3-2 Applicable those directly connected to the public low-voltage power
Voltage fluctuations/ Not supply network that supplies buildings used for domestic
flicker emissions Applicable purposes.
IEC 61000-3-3
Guidance and Manufacturer’s declaration – electromagnetic immunity-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration - electromagnetic immunity
The MD300C1 Pulse Oximeter is intended for use in the electromagnetic environment specified
below. The customer or the user of the MD300C1 Pulse Oximeter should assure that it is used in
such an environment.
Immunity test IEC 60601 Compliance Electromagnetic Environment –
test level Level guidance
Electrostatic +/- 6kV +/- 6kV Floors should be wood, concrete or
Discharge (ESD) contact contact ceramic tile. If floor are covered with
IEC 61000-4-2 +/- 8kV air +/- 8kV air synthetic material, the relative humidity
should be at least 30%.
Power frequency (50/60 3A/m 3A/m Power frequency magnetic fields should
Hz) magnetic field be at levels characteristics of a typical
IEC 61000-4-8 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 MD300C1 Pulse Oximeter is intended for use in the electromagnetic environment specified
below. The customer or the user of the MD300C1 Pulse Oximeter should assure that it is used in
such an environment.
Immunity IEC 60601 Compliance Electromagnetic Environment – guidance
test test level Level
Radiated 3 V/m 3 V/m Portable and mobile RF communications equipment
RF 80 MHz to should be used no closer to any part of the Pulse
IEC 2.5 GHz Oximeter (MD300C1), including cables, than the
61000-4-3 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

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determined by an electromagnetic site surveya,

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 (MD300C1) 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 (MD300C1).
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 P ulse Oxim eter (M D300C1)
The Pulse Oximeter (MD300C1) is intended for use in electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter
(MD300C1) can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Pulse
Oximeter (MD300C1) as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter (m)
output power of 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter (W)

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
SpO2 or PR can 1. Finger is not inserted correctly 1.Retry by inserting the finger
not be shown 2. Patient’s Oxyhemoglobin value is too 2. Try some more times. If you can
low to be measured make sure no problem exist in the
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normally product, please go to a hospital

timely for exact diagnosis.
SpO2 or PR is 1. Finger might not be inserted deep 1. Retry by inserting the finger
shown unstably enough. 2. Try not to move
2. Finger is trembling or patient’s body is
in movement status.
The oximeter 1. Power of batteries might be inadequate 1. Please replace batteries
can not be or not be there at all. 2. Please reinstall the batteries
powered on 2. Batteries might be installed incorrectly. 3. Please contact with local customer
3. The oximeter might be damaged. service centre
Indication 1. The product is automatically powered 1. Normal
lamps are off when no signal is detected longer 2. Replace the batteries
suddenly off than 8 seconds
2. Power quantity of the batteries is
started being inadequate
“Error3” or 1. Low power 1. Change batteries
“Error4” is 2. Receiving tube being shielded or 2. Please contact local customer
displayed on damaged together with broken service center
screen connector. 3. Please contact local customer
3. Mechanical Misplace for service center
receive-emission tube. 4. Please contact local customer
4. Amp circuit malfunctions. service center
Please contact local customer service
Error 6 Err 6 means the screen is failure
center
“Error7” is 1. Low power 1 Please change battery
displayed on 2. Emission tube damaged. 2 Please contact local customer
screen 3. Current control circuit malfunctions. service center
3 Please contact local customer
service center
Symbol Definitions
Symb
Symbol Definition Definition
ol
Type BF applied part. Attention.
Protected against dripping
﹪SpO2 Oxygen saturation
water.
Pulse rate (BPM) Low power indication
No SpO2 Alarm Power switch
Storage temperature and
relative Follow instruction for use
humidity
Date of Manufacture SN Serial No.
European union approval Manufacturer’s information
Authorized representative in Waste electrical and electronic
the European community equipment

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Box Content
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
Applicable Models
MD300C1 series:
LED screen
MD300C1 MD300C12 MD300C13 MD300C15 MD300C16 MD300C17 MD300C19
MD300C1A MD300C1B MD300C1C MD300C1D MD300C1E MD300C1F MD300C1G
MD300C1H MD300C1I
LCD screen
MD300C15D MD300C15F MD300C150
MD300C4 series:
MD300C4 MD300C41 MD300C42 MD300C11
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: December 05，2014

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