PULSE OXIMETER

INSTRUCTION
MANUAL MD300I
 Copyright Content
Our company owns all rights of this unpublished work and intends to maintain it as a 1 Introduction.....................................................................................................1
confidential work. We may also seek to maintain this work as an unpublished copyright. This 1.1 Brief Introduction.................................................................................................................1
publication is to be used solely for the purpose of reference or operation of our software
system. No part of this work can be disseminated for other purposes. 1.2 Intended Use.......................................................................................................................1

In the event of inadvertent or deliberate publication, we intend to enforce its right to this work 1.3 Measurement Principle........................................................................................................1
under copyright laws as a published work. Those having access to this work may not copy, 1.4 Safety Information...............................................................................................................1
use, or disclose the information in this work unless expressly authorized by our company.
1.5 Electromagnetic Interference..............................................................................................4
All information contained in this publication is believed to be correct. We shall not be liable for
1.6 Explanation of Symbols.......................................................................................................5
errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this material. The information this publication refers to is 1.7 Product Features.................................................................................................................5
protected by copyrights or patents and does not convey any license under the patent rights CHAPTER 2 General Descriptions..................................................................7
of our company, nor the rights of others. We do not assume any liability arising out of any
2.2 Battery Installation...............................................................................................................7
infringements of patents or other rights of third parties.
2.3 Sensor Connection..............................................................................................................8
Content of the manual is subject to change without prior notice.
CHAPTER 3 Take a Measurement...................................................................9
3.1 Before Measurement...........................................................................................................9
All rights reserved.
3.2 Display.................................................................................................................................9
Version: Ver3.0I1
3.3 Warning.............................................................................................................................10
Revised date:January 29, 2018
CHAPTER 4 Settings......................................................................................12
4.1 Brief Introduction of Setting...............................................................................................12
4.2 Parameters Change..........................................................................................................12
4.3 Brightness Adjustment.......................................................................................................12
4.4 Data Replay and Transmission.........................................................................................13

CHAPTER 5 Maintenance and Repair...........................................................14

5.1 Maintenance......................................................................................................................14
5.2 Cleaning and Calibrating...................................................................................................14
5.3 Troubleshooting.................................................................................................................14
5.4 Warranty and Repair.........................................................................................................15
APPENDIX A Specifications..........................................................................18
APPENDIX B declaration...............................................................................21
INSTRUCTION MANUAL MD300I

1 Introduction
1.1 Brief Introduction
Thank you for purchasing the handheld pulse oximeter for the functional oxygen saturation of
arterial hemoglobin (SpO2) and Pulse Rate (PR) measurement. The pulse oximeter features
PR tone modulation, data storage and data transmission capabilities. Please read the user
manual carefully before using this instrument.
Note:
• The illustrations applied in the manual may differ slightly from the actual device.
• The specifications are subject to change without prior notice.
• The device is designed of handheld structure and please be sure not to turn upside
down when using it.
1.2 Intended Use
The MD300I 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 patient
at home and hospital (including clinical use in internist/surgery, Anesthesia, intensive care
and etc). It is not for continuous monitoring.
1.3 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.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
1.4 Safety Information
Conception of Warning, Caution and Note
The Warning, Caution and Note at this document are special information in favor of user’s
operation.
• Warning - Indicates a potential hazard or unsafe practice that, if not avoided, will result
in death or serious injury.
• Caution - Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

• Note - Provides application tips or other useful information to ensure that you get the • This equipment is not intended for use during patient transport outside the healthcare
most from your product. facility
• • When connecting this device to other peripherals, make sure that you are qualified to
operate this device. Any peripheral must be certified according to the protocol of IEC
Warnings!
950 and IEC 601-1-1. Any input/output device should follow the protocol of IEC 601-1-
• Before use, carefully read the manual. This device is intended for use by persons 1.
trained in professional health care. Our company will assume no warranty for using
• Rx only: “Caution: Federal law restricts this device to sale by or on the order of a
this equipment improperly.
physician.”
• The handheld pulse oximeter is to be operated by qualified personnel only.
Cautions:
• Operation of the handheld pulse oximeter may be affected by the use of an
electrosurgical unit (ESU). • The handheld pulse oximeter must be able to measure the pulse properly to obtain an
accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement
• Sensor malfunction may cause inaccurate data possibly resulting in patient injury or
before relying on the SpO2 measurement.
death, so pay close attention to the sensor and inspect it often.
• Worn-out data cables may also cause inaccurate data, so if the data is used as a
• Do not use the handheld pulse oximeter in an MRI or CT environment.
reference to treat a patient, pay special attention to data cable and check it more
• Although the pulse oximeter has alarms, it is not suggested for long time continuous frequently.
monitoring.
• Do not tangle the SpO2 cable with the wires of ES (Electrosurgery) equipment.
• Do not use the handheld pulse oximeter in an explosive atmosphere.
• Single use accessories should never be reused.
• The handheld pulse oximeter is intended only as an adjunct in patient assessment.
• Only use SpO2 sensors specified by the manufacturer. Other SpO2 sensors may
It must be used in conjunction with other methods of assessing clinical signs and
cause improper performance.
symptoms.
• Unplug the sensor from the monitor before cleaning or disinfecting to prevent sensor
• Check the pulse oximeter sensor application site every 4 hours to determine the
or monitor from being damaged, and to prevent user under safety situation.
positioning of the sensor and circulation and skin sensitivity of the patient.
• Alarm must be set up according to different situation of individual patient. Make sure
• When link this equipment to other peripherals, make sure you are sophisticated
that audio sound can be activated when alarm occurs.
operator to handle this device. Any peripherals should be in the light of protocol of IEC
950 and IEC 601-1-1. Any input/output device should be following the protocol of IEC • To avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it
601-1-1. with liquid cleaning agents. Always take out the batteries before cleaning.

• Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing • If oximeter becomes accidentally wet during use, stop operation of the oximeter until
the device in liquid. The device is not intended for sterilization. all affected components have been cleaned and permitted to dry completely. Contact
your local representative if additional information is required.
• Follow local ordinances and recycling instructions regarding disposal or recycling of
the device and device components, including batteries. • Portable and mobile RF communications equipment can affect medical electrical
equipment.
• This equipment complies with IEC 60601-1-2:2007 for electromagnetic compatibility
for medical electrical equipment and/or systems. However, because of the proliferation • This equipment is not intended for use during patient transport outside the healthcare
of radio-frequency transmitting equipment and other sources of electrical noise in facility
healthcare and other environments, it is possible that high levels of such interference • This equipment should not be used adjacent to or stacked with other equipment.
due to close proximity or strength of a source might disrupt the performance of this • Do not disassemble, repair or modify the equipment without authority.
device. • These materials that contact with the patient’s skin contain medical silicone and
• Portable and mobile RF communications equipment can affect medical electrical ABS plastic enclosure are all pass the ISO10993-5 Tests for invitro cytotoxicity and
equipment. ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
• You should operate the equipment according to the EMC information provided in the Notes:
accompanying documents. • Optical cross talk can occur when two or more sensors are located in adjoining areas.
• This equipment should not be used adjacent to or stacked with other equipment. It can be eliminated by covering each site with opaque material. Optical cross talk may

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

adversely affect the accuracy of the SpO2 readings. this international standard are: CISPR11, GROP1, and CLASS B.
• Obstructions or dirt on the sensor’s red light or detector may cause a sensor failure. 1.6 Explanation of Symbols
Make sure there are no obstructions and the sensor is clean.
• Any condition that restricts blood flow, such as use of a blood pressure cuff or Symbol Definition
extremes in systemic vascular resistance, may cause a failure to determine accurate
pulse rate and SpO2 readings.
Caution
• Hazards arising from software errors have been minimized. Hazard analysis conforms
to meet ISO14971: 2000 and EN60601-1-4: 1996. Significant levels of dysfunctional
Follow instructions for use
hemoglobin, such as carboxyhemoglogin or methhemoglobin, will spawn an affection
of the accuracy of the SpO2 measurement.
Type BF applied part.
• The handheld pulse oximeter can monitor only one patient synchronously.
• For routine equipment maintenance, please refer to the service procedures at the Protected against dripping water.
associated section as indicated in the manual.
• As to the other concerns for attention, please carefully look through the specific SpO2% Oxygen Saturation.
chapter in this instruction.
Inaccurate measurements may be caused by: Low power indication.
• Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or
methemoglobin); No SpO2 Alarm.
• Intravascular dyes such as indocyanine green or methylene blue;
• High ambient light. Shield the sensor area if necessary;
SN Serial No.
• Excessive patient movement;
• High-frequency electrosurgical interference and defibrillators;
• Venous pulsations; Storage temperature and relative humidity.
• Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line;
• The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia; Waste electrical and electronic equipment
• The patient is in cardiac arrest or is in shock;
• Fingernail polish or false fingernails; Manufacturer’s information.
• Weak pulse quality (low perfusion);
• Low hemoglobin;
Date of Manufacture.
1.5 Electromagnetic Interference
This oximeter is designed and tested in compliance with the EMC standard, complying with
European union approval.
the international standard for the EMC of the electronic medical device - IEC 60601-1-2.
However, because of the proliferation of radio frequency transmitting equipment and other
sources of electrical noise in the health-care and home environments (e.g. cellular phones, Authorized representative in the European community.
mobile two-way radios, electrical appliances) it is possible that high levels of such interference
due to close proximity or strength of a source, may result in disruption of performance of this 1.7 Product Features
device. ● Simple to use and easy to operate.
This apparatus complies with the IEC 60601-1-2 international standard. The requirements of ● Portable and compact in design.

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

● OLED display screen with adjustable backlight.

● Up to 10 patients’ IDs and 72-hour records can be saved.
CHAPTER 2 General Descriptions
● Data transfer to PC by USB cable. 2.1 Appearance
● Powered by two AA alkaline.
● Suitable for adult and pediatric patients.

Fig.2-1 Appearance of the oximeter

Sensor Interface: This interface is designed for two purposes, one is to connect the SpO2
probe for measurement, and the other is to connect the pulse oximeter to PC with USB cable
for data transmission.
Function key - at the left of the oximeter, acts as a power on switch when the oximeter is
power off. While the oximeter is power on, it acts as a function key.
Setting key - at the right of the oximeter, while the oximeter is power on, it acts as a setting
key.
While there is no measurement or operation the oximeter will power off automatically in 30
seconds.
2.2 Battery Installation
1. Slide the battery door cover along the arrow as shown in Fig.2-2.
2. Install two AA 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.
3. Replace the battery cover.

Warning!

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Install the batteries with the correct polarity. Incorrect placement may cause damage to the
bracket. CHAPTER 3 Take a Measurement
Note:
Definition of key press
Please remove the batteries if the pulse oximeter will not be used for long periods of time.
There are three ways to press the key:
A low voltage warning will be indicated with flashing when the battery voltage is lower 1. Press: press the key quickly, the duration time should no more than 1 second.
than 2.7V. Please replace the batteries as soon as possible, otherwise normal operation of
the oximeter might be influenced. 2. Double press: Two-time continuous press, the time between the two press action should
no more than 0.5 second.
3. Longtime press: press the key for a long time, the time should more than 1.5 seconds.
3.1 Before Measurement
Press the key in the left of the oximeter to power the device on.
Clip the sensor to the rational position of the patient finger, and ensure the patient’s nail
surface is facing upward as shown in Fig.3-1.

Fig.3-1 Placement of the finger

Fig.2-2 Fig.2-3 3.2 Display
2.3 Sensor Connection The handheld pulse oximeter can display the SpO2 and pulse rate (PR) value, pulse bar as
Select an appropriate sensor, and then connect the sensor to the top of the oximeter as well as SpO2 waveform and perfusion indication.
shown in Fig.2-4. Ensure that the sensor is firmly plugged in. There are 3 display modes for the handheld pulse oximeter. After turning on the device, each
time the function key (left key) is pressed, the handheld pulse oximeter will switch to another
display mode as shown in the following figures.

Fig.2-4
The interface is also used for transferring data to the software for management. To transfer
data, please connect the data cable to the interface. For detailed information, refer to
MedView software instruction manual.
Notes:
1. Please make the raised lump side of sensor cable upside when inserting the sensor. Fig.3-2 (1) Pulse column display mode
2. Do not insert the sensor forcefully.

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Low priority: indicates the technical alarm caused by the device itself.
Alarms of the oximeter include technical and physiological alarms. All the three priorities are
divided by built-in module and cannot be changed by user.
Assignment of priority:

Alarm
Event Display Audiblesound
priority
Fig.3-2 (2). Filled waveform mode Fig.3-2 (3). Line waveform mode High The SpO2 is beyond The SpO2 value is “Di- Di – Di ----- Di - Di”, “Di-
the limits flashing Di – Di ----- Di - Di” once
The first figure is pulse column display mode. The second figure is filled waveform mode. The
circularly every 3 seconds
third figure is line waveform mode indicating SpO2% trend. Medium The pulse rate is The pulse rate “Di - Di - Di”, once circularly
PR tone modulation: Beeps in sync with the patient’s pulse, even under most challenging beyond the limits value is flashing every 5 seconds
patient motion conditions, except when in the (2) mode. Low The probe or finger Finger out “Di”, once circularly every 20
is not inserted Probe off seconds
3.3 Warning
Warning: Technical warning and physiological warning.
Technical warning: finger out, probe off, power low and error code.
In the situation that the finger is not inserted correctly or the connection state of the probe is
not good results in failure of measurement, “Finger out” or ”Sensor off” may be displayed on
the normal screen.
When battery power is lower than 2.6±0.1V, the sign will flicker in its display area.
Replace the batteries as soon as possible.
In the failure state, the oximeter will display error codes, and will automatically power off if
the error code display lasts for more than 30 seconds. For the details and definitions on error,
please refer to chapter 5.3.
Physiological warning: SpO2 and PR
If the measured SpO2 and/or PR value is beyond the default limit, the corresponding value
will flash with audible sound.
By default:
SpO2: The upper limit: 100%, The lower limit: 90%
PR: The upper limit: 100bpm, The lower limit: 60bpm
Note: During the warning is issued, press the functional button, you can silence the alarm for
30 seconds. And press it again, the screen switches between pulse column display mode,
filled waveform mode and line waveform mode.
ALARM PRIORITY:
There are three-level priorities for selection.
High priority: indicates the patient is in the very dangerous situation.
Medium priority: indicates the warnings should be paid attention to.

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Holding the function key (left key) for more than one second, the brightness level headed with
CHAPTER 4 Settings “Br” will be shown on the top right of the screen. You can adjust the brightness by degrees by
pressing the setting key (right key). There are 7 levels of brightness in all. The default is level 3.
4.1 Brief Introduction of Setting
You can enter or exit the setting only under “measure mode” and “information display mode”
in order to set the brightness, patient ID, date and time.
Enter setting: Press the function key for more than one second, the oximeter will enter
setting.
Save and exit setting: Press function key and setting key simultaneously, the modification
under the setting mode will be saved, at the same time, the system will exit from setting mode
and return to “non-setting mode”. Fig.4-1
4.4 Data Replay and Transmission
Cancel and exit from setting: Under the “setting mode”, press function board twice, the
modification under setting mode will be canceled, at the same time, the system will exit from The oximeter can record SpO2 and PR value for more than 72 hours, and can analyze
setting and return to “non-setting mode”. records one by one. You can transfer the history data to a PC by using “MEDVIEW”
software and an attached data cable. As for detailed setup and operation, please refer to the
If there is no operation under “setting mode” in 10 seconds, the modification under “setting “MEDVIEW” operator’s manual.
mode” will be canceled automatically, at the same time, the system will exit from “setting
mode” and return to “non-setting mode”.
4.2 Parameters Change
Enter the Setting Mode under the “Measure mode”, you can only set Brightness and Patient
ID. Enter the Setting Mode under the “Information Display mode”, you can set Brightness,
Patient ID, Date and Time. Current parameters and data will be displayed at the top right
corner which is used to display the “PR”. The various parameters display title is as follows:
Br(brightness)-->ID(patientID)-->Y(year)-->M(month)-->D(date)-->H(hour)-->m(minute)--
>S(second)--Br(brightness)-->...
Br: brightness, range: 1-7.
ID: patient ID, range: 1-10.
Y: year, range: 0-99, short for 2000-2099.
M: month, range: 1-12.
D: day, range: 1-31.
H: hour, range: 0-23.
m: minute, range: 0-59.
S: second, range: 0-59.
Change current value of the parameter
Press “setting key”, current parameter setting will be added by 1 unit.
Double press or longtime press “setting key”, current parameter setting will be added by 10
units.
4.3 Brightness Adjustment
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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Err 7: sensor emission diode or receipt diode damaged.

CHAPTER 5 Maintenance and Repair Err 9: real time clock damaged.
Warnings! Err 10: EEPROM chip damaged.
• The advanced circuit inside the oximeter does not require periodic calibration and
b) Possible problems and corresponding solutions
maintenance, except replacing the batteries.
• Don’t open the cover of oximeter or repair electronic circuits. Its open will cause the Problems Possible Reason Solution
damage of the device and the annulment of the guarantee. SpO2 or PR 1. Finger is not plugged 1. Retry by plugging the finger
cannot be correctly 2. Attempt several times to obtain
5.1 Maintenance
displayed 2. Patient’s Oxyhemoglobin a reading, If you are sure that no
Replace the batteries in a timely manner when low voltage lamp is lighted. normally value is too low to be measured problem exists, obtain further clinical
Clean surface of the oximeter before it is used in diagnosis for patients. examination
SpO 2 or PR 1. Finger might not be plugged 1. Retry by plugging the finger
Remove the batteries if the oximeter is not operated for a long time.
display is deep enough 2. Urge the patient to remain still
It is best to store the product in -20℃～ +55℃ and ≤93% humidity. unstable 2. Finger is trembling or patient
Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage. is moving continually
The 1. Battery power may be 1. Please replace batteries
Dispose of batteries properly; follow any applicable local battery disposal laws. Oximeter inadequate or not installed 2. Please reinstall the batteries
5.2 Cleaning and Calibrating cannot be 2. Batteries might be installed 3.Contact local customer Technical
powered on incorrectly Service
Please use medical alcohol to clean the silicone touching the finger inside of SpO2 probe with
3. The Oximeter might be
a soft cloth dampened with 70% isopropyl alcohol. Also clean the being tested finger using
damaged
alcohol before and after each test. “Error3” or 1. Receiving diode may be 1.Contact local customer Technical
Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any “Error4” shielded or damaged together Service
openings in the device. Allow the oximeter to dry thoroughly before reuse. Displayed on with broken connector. 2.Contact local customer Technical
screen 2. Mechanical Misplace for Service
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor
receive-emission diode 3.Contact local customer Technical
or sensor. Clinical testing is used to establish the SpO2 accuracy. The measured arterial
3. Amp circuit malfunction. Service
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 “Error7” 1. Emission diode damaged. 1 Contact local customer Technical
accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 displayed on 2. Current control circuit Service
range of 70–99%. Accuracy data is calculated using the root-mean-squared (Arms value) for screen malfunction. 2 Contact local customer Technical
all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular requirements for the Service
basic safety and essential performance of pulse oximeter equipment for medical use.
“Probe off” 1. The sensor is not connected 1.Connect the sensor
5.3 Troubleshooting displayed on 2 The connection between the 2. Please check if the probe was
a) Error Definitions screen Probe and Oximeter is loose connected with oximeter correctly
Err 1: program memory damaged. 5.4 Warranty and Repair
Err 2: data memory damaged.
5.4.1 Service Method
Err 3: sensor Red Emission Diode damaged. Service support: Our company will offer user telephone and e-mail support as well as in-
Err 4: sensor Infrared-ray Emission Diode damaged. house repair at our facility.

Err 5: sensor Infrared-ray Receipt Diode damaged. Parts replacement: Our company will replace parts, accessories, free of charge during the
warranty period.
Err 6: exterior crystal oscillator damaged.

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Our company will update the system software free of charge. • Not carefully read manual and so wrong operation lead to oximeter damage and
failure.
5.4.2 Exempt and Limitation 5.4.5 User’s Special Request for Guarantee Time
a) Our company isn’t responsible for such damage caused by force majeure. For example:
fire, thunder flash, flood, cyclone, hail, earthquake, house collapse, commotion, plane failing Our guarantee constitution for oximeter complies with electronic product after-sale service
and traffic accident, deliberate damage, lack of fuel or water, labor and capital bother, strike standard regulated by national laws. We regulate the guarantee time of hoist board is one
and stop-working etc. year and all the accessories are three months. If users request the guarantee time beyond
our regulated guarantee time, we should take it into consideration. Because electronic
b) No-service offer product has such character of quick changing, for such user asking more than three years
The corresponding charge and insurance charge of disassembling, refurbishing, repackaging guarantee time, our company will not sell oximeter parts during maintenance. Our company
and moving the oximeter or the part of it. will upgrade oximeter or change new maintenance methods, for this, we charge the lowest
The damage caused by the third company not commended by our company to adjust, install, price for new oximeter with user permission.
replace the parts of the oximeter. 5.4.6 Repackage
The damage and failure caused by user or its representative doesn’t comply with the • Take all the accessories and put them into plastic cover.
operator’s manual. • Try to use original package and packing material. User will be responsible for such
c) The oximeter is installed or connected with such external device without our company damage caused by bad package during transportation.
permission as printer, computer, net line and lead to oximeter failure. Our company will • Please offer guarantee list and copy of invoice to standby with the period of guarantee.
charge for the maintenance. • Please describe failure phenomenon in detail and altogether offer oximeter.
d) Responsibility limitation Storage and Transportation
During the period of maintenance contract validity, if user changes the parts manufactured Storage: Storage Temperature -20℃ ~ +55℃ , Relative Humidity ≤93%, no condensation.
by other manufacturers without our company permission, our company is entitled to stop Transportation: Transport by airline, train or vessel after packing according to request.
contract.
Package
5.4.3 User Guarantee
Pack the product with the hard bag, and put the foam between the inner box and the carton
a) Please read user manual carefully before operation. to alleviate the shake.
b) Please operate and make daily maintenance as request of manual and guarantee.
c) Power supply and environment.
5.4.4 No-guarantee Principle
• There is no-dispelled smut and not-original mark in the crust.
• There is physical damage on oximeter and its accessory.
• There are liquid leftover and eyewinker on oximeter, which may lead to short circuit
and plug board failure.
• All the probe and accessories belong to consumption and beyond free change range.
• Such damage of probe caused by mechanical force doesn’t belong to free change
range.
• During measurement of SPO 2, principle leads to measuring value difficultly or
inaccurate measurement.
• Not-original package leads to damaging oximeter during transportation
• Not our company professionals or authorized personnel disassemble oximeter and
lead to oximeter failure.

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Data Cable Interface: DB9 (Connect to Pulse Oximeter); USB (Connect to PC)
APPENDIX A Specifications Environment Requirements
Notes: Operating Temperature: 5℃ ~ 40℃
Specifications may be changed without prior notice.
Storage Temperature: -20℃ ~ +55℃
The circuit diagrams, the list of components, the illustrations of diagrams, and the detailed Operating Humidity: ≤80%RH, no condensation
rules of calibration are provided exclusively to professional personnel authorized by our
Storage Humidity: ≤93%RH, no condensation
company.
Classification per IEC60601-1
Display
Type: OLED Classification according to IEC-60601-1
Parameters: SpO2, Pulse Rate, Plethysmogram, Pulse bar According to the type of protection
Internal electrical power source equipment
against Electrical shock:
Mode: 3 display modes.
According to the degree of protection
Data update time: 15s Type BF equipment
against Electrical shock:
SpO2
According to the degree of protection
Display Range: 0% ~ 99% IPX1
against harmful ingress of water.
Resolution: 1%
According to the methods of Non-sterilizable: Use of Liquid surface
Accuracy: 70% ~ 99%: ±2% 0% ~ 69%: unspecified sterilization or disinfection disinfectants only.
Pulse Rate According to the mode of operation: Continuous operation
Measuring Range: 30bpm ~ 235 bpm Equipment not suitable for use in the presence of a flammable anesthetic mixture air or
Resolution: 1bpm with oxygen or nitrous oxide.

Accuracy: ±2bpm Dimensions: 110 x 35 x 27mm (Length×Width×Height)

Probe LED Specifications Weight: 110g (with alkaline batteries)
Power Supply
Wavelength Radiant Power
Type: 2 AA Alkaline batteries
RED 660±2nm 1.8mW Operation time: About 24 hours of typical operation
Voltage: +3.3 ± 0.17 V DC
IR 940±10nm 2.0mW
Average Current: 30mA
Alarm Accessories
Alarm: Probe off, Finger out, Low power Standard accessories:
Modes: visual information One user manual;
Record One finger sensor for adult (Model: M-50A);
Two AA-Size Alkaline batteries;
Patient ID: 10 patients
One MedView software CD;
Data record: Up to 72 hours
One data cable;
Data Transmission
Optional accessories:
Transmission Method: Cable Transmission

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 MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Binding sensor for pediatric

(Pediatric 15-45 Kg).
APPENDIX B Declaration
Model: M-50B Guidance and manufacturer’s declaration - Electromagnetic emission----
for all EQUIPMENT AND SYSTEM
Confirm that the items listed are packed with the pulse oximeter. If any item on this list is
1 Guidance and manufacturer’s declaration- electromagnetic emission
missed or damaged, contact your distributor. Contact the carrier immediately if the shipping
carton is damaged. 2 The model MD300I Pulse Oximeter is intended for use in the electromagnetic
specified below. The customer or the user of the model MD300I Pulse Oximeter
should assure that it is such an environment.
3 Emissions Compliance Electromagnetic environment-guidance
test
4 RF Group 1 The model MD300I Pulse Oximeter uses RF
emissions energy only for its internal function. Therefore,
CISPR11 its RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
5 RF Group B
emissions
CISPR11
6 Harmonic Class A
emissions
IEC 61000-
3-2
7 Voltage Complies
fluctuations/
IEC 61000-
3-3

Guidance and manufacturer’s declaration - Electromagnetic Immunity-

For all Equipment and Systems
Guidance and manufacturer’s declaration- electromagnetic immunity
The model MD300I Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of the model MD300I
Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic
test level environment-guidance
Electrostatic ±6kV contact ±6kV contact Floors should be
discharge ±8kV air ±8kV air wood，concrete or
（ESD）IEC ceramic tile. If floors are
61000-4-2 covered with synthetic
material，the relative
humidity should be at
least 30%.

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MD300I PULSE OXIMETER INSTRUCTION MANUAL MD300I

Electrostatic ±2kV for ±2kV for power Mains power quality Portable and mobile RF
transient/burst power supply supply lines should be that of a communications equipment should be
IEC 61000-4-4 lines ±1kV for input/output typical commercial or used no closer to any part of the model
±1kV for input/ lines hospital environment. MD300I Pulse Oximeter, including
output lines cables, than the recommended
Surge IEC ±1kV ±1kV differential Mains power quality separation distance calculated from the
61000-4-5 differential mode should be that of a equation applicable to the frequency of
mode ±2kV common mode typical commercial or the transmitter.
±2kV common hospital environment. Recommended separation distance
mode
Voltage dips, <5% UT <5% UT Mains power quality
short （ >95%dip in （ >95%dip in UT） should be that of a
Conducted 3Vrms 3V 80MHz to 800MHz
interruptions UT） for 0.5 cycles typical commercial or
and for 0.5 cycles 40% UT hospital environment. RF IEC 150kHz
800MHz to 2.5GHz
voltage 40% UT （ 60%dip in UT） If the user of the 61000-4-6 to 80MHz
Where P is the maximum output
variations （ 60%dip in for 5 cycles model MD300I Pulse
power rating of the transmitter in
o n p o w e r UT） 70% UT Oximeter requires
Radiated 3V/m Watts (W) according to the transmitter
supply for 5 cycles （ 30%dip in UT） continued operation
manufacture and d is the recommended
input lines 70% UT For2 5 cycles during power main RF IEC 80MHz 3V/m separation distance in meters (m).
IEC 61000-4-11 （ 30%dip in <5% UT interruptions, it is
61000-4-3 to 2.5GHz Field strengths from fixed RF
UT） （ >95%dip in UT） recommended that the
For2 5 cycles for 5 sec model MD300I Pulse transmitters, as determined by an
<5% UT Oximeter be powered electromagnetic site survey,a should be
（ >95%dip in from an uninterruptible less than the compliance level in each
UT） power supply or a frequency range.b
for 5 sec battery. Interference may occur in the vicinity of
Power 3A/m 3A/m Power frequency
equipment marked with the following
frequency magnetic fields should
symbol:
(50/60Hz) be at levels characteristic
magnetic field of a typical location in
IEC 61000-4-8 a typical commercial or
NOTE1 At 80MHz and 800MHz, the higher frequency range applies.
hospital environment.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is
NOTE UT is the a.c. mains voltage prior to application of the test level. affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base situation for radio (cellular/
Guidance and manufacturer’s declaration- electromagnetic immunity- cordless) telephones and land/mobile radios, amateur radio, AM and FM radio broadcast
For EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
Guidance and manufacturer’s declaration – electromagnetic immunity should be considered. If the measured field strength in the location in which the model
The model MD300I Pulse Oximeter is intended for use in the electromagnetic specified
MD300I Pulse Oximeter is used exceeds the applicable RF compliance level above, the
below. The customer of the user of the MD300I Pulse Oximeter should assure that it is
Pulse Oximeter should be observed to verify normal operation. If abnormal performance
used in such an environment.
is observed, the additional measures may be necessary, such as reorienting or relocating
Immunity IEC 60601 Compliance Electromagnetic environment-
the model MD300I Pulse Oximeter.
test test level level guidance
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

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 MD300I PULSE OXIMETER

Recommended separation distances between portable and mobile RF communications

equipment and the EQUIPMENT or SYSTEM-for EQIPMENT and SYSTEMS that are not
LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications

equipment and the MD300I Pulse Oximeter
The model MD300I Pulse Oximeter is intended for use in an electromagnetic
environment in which radiated RF disturbance are controlled. The customer or the user
of the model MD300I Pulse Oximeter can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communication
equipment ( transmitters) and the model MD300I Pulse Oximeter as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum
output of 150KHz to 80 MHz 80MHz to 800 MHz 800MHz to 2.5 GHz
transmitter(W)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance 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.
MD300I
NOTE1 At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic interference is
affected by absorption and reflection from structures, objects and people.

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