oxycure MD300 C63 User manual

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 1
Fingertip Puls Oximeter
MD300 C63
User manual
Start-up: summarised instructions
1. Before use, disinfect the device and the finger used for measured.
2. Insert your finger into the device until the end and nail towards the screen!
3. Press the start / stop button
4. Remove the finger. The device turns off automatically.
Periodic maintenance.
1. Regular disinfection.

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 2
Thank you for choosing an Oxycure concentrator.
The Oxycure range, from left to right
Oxycure portable concentrators
Oxycure portable concentrator – Inogen G4
Oxycure portable concentrator – Inogen G3
Oxycure portable concentrator – Zen-O lite
Oxycure portable concentrator – Simply Go Mini
Oxycure portable concentrator – SimplyGo
Oxycure portable concentrator – eQuinox
Oxycure concentrators
Oxycure – Kröber concentrator
Oxycure cylinders (gaseous oxygen)
Oxycure B2 cylinder – 0.4 m³
Oxycure B5 cylinder – 1.0 m³
Oxycure tanks (liquid oxygen)
Oxycure liquid oxygen tank – 25.6 m³
Oxycure portable liquid oxygen tank (1.0 m³)
More information at www.oxycure.be

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 3
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 : [e-mail]
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.

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 4
OPERATOR’S
MANUAL
V1.0C63
Fingertip Pulse Oximeter
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 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 (HbO2) 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 Infrared-ray Receipt Tube
Precautions for use
1Do not use the pulse oximeter in an MRI or CT environment
2Do not use the pulse oximeter in situations where alarms are required.
3Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
4The 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.
5Check the pulse oximeter sensor application site frequently to determine the positioning
of the sensor and circulation and skin sensitivity of the patient.
6Do not stretch the adhesive tape while applying the pulse oximeter sensor. This may
cause inaccurate readings or skin blisters.
7Before use, carefully read the manual.
8The pulse oximeter has no SpO2alarms; it is not for continuous monitoring, as indicated
MD300C63

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 5
by the symbol.
9Prolonged 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 may cause inaccurate readings.
11 Significant levels of dysfunctional hemoglobins (such as carbonxy- hemoglobin or
methemoglobin)
12 Intravascular dyes such as indocyanine green or methylene blue
13 SpO2measurements 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
15 Venous pulsations
16 Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line.
17 The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia
18 The patient is in cardiac arrest or is in shock.
19 Fingernail polish or false fingernails may cause inaccurate SpO2readings.
Follow local ordinances and recycling instructions regarding disposal or recycling
of the device and device components, including batteries.
Product Properties
1Operation of the product is simple and convenient.
2The product is small in volume, light in weight and convenient in carrying.
3Power consumption of the product is low.
4Low voltage warning will be indicated in visual window when battery voltage is so low
that normal operation of the Oximeter might be influenced.
5The product will automatically be powered off when no signal is in the product for longer
than 8 seconds.
Product Operation Scope
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 and etc). Not
for continuously monitoring.
The PULSE OXIMETER requires no routine calibration or maintenance other than
replacement of batteries.
Operation Instructions
1Installing two AAA batteries correctly.
2Nip the clamp as diagram.
3Insert one finger into rubber hole of the Oximeter fully.
4Press the switch button once on front panel.
5Your finger and body do not tremble during the Oximeter is working.
6Read corresponding data from display screen.
7Six display modes

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 6
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. 2. 3.
4. 5. 6.
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.
NOTE: Please use the 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 to medical rubber, which has no toxin and no harm to the
skin of human being).
When your finger is plugged into the Oximeter, your nail surface must
be upward.
Brief Description of Front Panel
The PR 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. One lanyard
2. Two batteries
3. One user manual
Battery Installation
1. Put the two AAA batteries into battery cassette with correct polarities.
2. Push the battery cover horizontally along the arrow shown as below:
Notes: Battery polarities must be correctly installed. Otherwise,
damage might be caused to device.
Please put or remove batteries in right order, or is likely to damage the
device bracket.
Please remove batteries if the Oximeter will not be used for a long time.
Lanyard Installation
1. Thread thinner end of the hang lace through the hanging hole.
PR Bar graph
Low power indicator
SPO2waveform
SpO2
Pulse Rate

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 7
2. Thread thicker end of the lace through the threaded end before pulling it tightly.
Maintenance and Storage
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 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 temperature –20～55℃ and
humidity is <93% (no condensation).
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 batteries.
Calibration
1. The functional tester cannot be used to assess the accuracy of the Oximeter.
2. Index 2 that made by Bioteck company is a function tester. Set Tech to 1, R curve to 2,
and then a user can use this particular calibration curve to measure the Oximeter.
3. The test methods used to establish the SpO2accuracy 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-
O x i m e t e r.
Declaration
EMC of this product complies with IEC60601-1-2 standard.
The materials which user can come into contact have no toxicity and no action on tissues,
complying with ISO10993-1,-5,-10.
Detailed descriptions of product functions
1. Display Type: OLED display
2. SpO2:
Measurement range:70-100%
Accuracy：70%-100%, ±3%; ≤70% no definition.
3. Pulse Rate:
Measure range：30~235 BPM
Accuracy：30~99bpm ±2bpm; 100~235bpm, ±2%.
Pulse Intensity: Bar graph Indicator
4. Power Requirements:
Two AAA alkaline Batteries
Power consumption: Less than 30mA
Low power indication:
Battery Life:
Two AAA 1.5V, 800mAh alkaline batteries could be continuously operated as long as
30 hours.
5. Dimension:
Length: 58mm

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 8
Width: 32mm
Height: 37mm
Weight: 33g (without batteries)
6. Environment Requirements:
Operation Temperature: 5～40℃
Storage Temperature: -20～55℃
Ambient Temperature: <80% in operation, no condensation.
<93% in storage, no condensation.
7. Declaration: EMC of this product complies with IEC60601-1-2 standard.
8. Measurement Performance in Low Perfusion Condition: required the test
equipment (BIO-TEK INDEX Pulse Oximeter tester) the pulse wave is available without
failure when the simulation pulse wave amplitude is at 0.6%.
9. Interference Resistance Capacity against Ambient Light: Device work normally
when mixed noise produced by BIO-TEK INDEX Pulse Oximeter tester.
Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified
below. The customer of the user of the Pulse Oximeter
should assure that it is used in
such and 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 emission
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.
Possible Problems and resolutions
Problems
Possible reason
Solution
SpO
2
or PR is
not displayed.
1. Finger is not inserted
correctly.
2. Patient’s SpO2value is too
low to be measured.
1..Re-insert the finger.
2. Try some more times, If you can
make sure about no problem
existing in the product. Please go
to a hospital timely for exact
diagnosis
SpO2or PR
reading is
unstable.
1. Finger is not inserted
correctly.
2.Excessive patient movement.
1..Re-insert the finger.
2. Restrict patient/ oximeter
movement.

D.SPEC.05.10 Pulse oxymètre MD300-C63 - Mode d'emploi_EN
v. 28/06/2019 9
The Oximeter
can not be
powered on.
1. No battery or low power of
battery.l
2. Batteries might be installed
incorrectly
3. The Oximeter might be
damaged
1. Replace batteries.
2. Reinstall batteries.
3. Contact with local customer
service centre.
Display
suddenly turns
off.
1. The oximeter will
automatically power off
when no signal is detected
longer than 8 seconds.
2. Battery power is low.
1. Normal
2. Replace batteries
“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 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
malfunction.
1 Please change battery
2 Please contact with local
customer service center
3 Please contact with local
customer service center
Symbol Definitions
Symbol
Definition
Type BF applied part.
Attention, consult accompanying documents.
SpO2
﹪
Oxygen saturation
Heart rate (BPM)
Low power indication
Not for continuous monitoring
SN
Serial No.
Issue date: 10/August 2009