Choice Electronics MD300W628 User manual

Wrist
Pulse Oximeter
MD300W628
INSTRUCTION
MANUAL

Copyright
Our company owns all rights to this unpublished work and intends to maintain this work as condential. Our company
may also seek to maintain this work as an unpublished copyright. This publication is to be used solely for the purpose of
reference, operation, maintenance or repair of our equipment. No part of this can be disseminated for other purposes.
In the event of inadvertent or deliberate publication, our company intends to enforce its right to this work under copyright
laws as a published work. Those having access to this manual may not copy, use, or disclose the information in this
work unless expressly authorized by our company to do so.
All information contained in this manual is believed to be correct. Our company shall not be liable for errors contained
herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this
material. This publication may refer to information and protected by copyrights or patents and does not convey any
license under the patent rights of our company, nor the rights of others. Our company does not assume any liability
arising out of any infringements of patents or other rights of third parties.
Content of the manual is subject to change without prior notice.
ALL RIGHTS RESERVED
Bluetooth® and the Bluetooth® Logo are registered trademarks of Bluetooth® SIG, Inc.
Version: Ver1.0
Issue Date: May 20, 2020

CONTENT
1 Introduction .........................................................................................................................................1
1.1 Brief Introduction ......................................................................................................................................................1
1.2 Safety Information ....................................................................................................................................................1
1.3 Intended Use ............................................................................................................................................................6
1.4 Electromagnetism Interference.................................................................................................................................6
1.5 Explanation of Symbols ............................................................................................................................................7
1.6 Product Features ......................................................................................................................................................8
2 General Description ............................................................................................................................9
2.1 Appearance ..............................................................................................................................................................9
2.2 Power Supply .........................................................................................................................................................10
3 Take a Measurement .........................................................................................................................12
3.1 Power On ................................................................................................................................................................12
3.2 Probe Installation ....................................................................................................................................................12
3.3 Take a Measurement ..............................................................................................................................................13
3.4 Data storage and transfmission .............................................................................................................................. 17

4 Settings ..............................................................................................................................................18
4.1 Indication Setting ....................................................................................................................................................18
4.2 Date Management ..................................................................................................................................................20
4.3 System Setting .......................................................................................................................................................21
4.4 Other Settings .........................................................................................................................................................22
5 Troubleshooting ................................................................................................................................23
6 Maintenance and Repairs .................................................................................................................24
6.1 Maintenance ...........................................................................................................................................................24
6.2 Safety Checks ........................................................................................................................................................24
6.3 Calibration and Verication .....................................................................................................................................26
6.4 Warranty and Repair...............................................................................................................................................27
7 FCC Declaration ................................................................................................................................32
Appendix A Specications ..................................................................................................................33
Appendix B Declaration.......................................................................................................................36

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1 Introduction
1.1 Brief Introduction
Thank you for purchasing MD300W628 Wrist Pulse Oximeter. The main functions of the device include
hemoglobin oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI) measurements, visual and
audible indication, data storage and transmission through Bluetooth®. Please read this manual carefully before
using the device.
Note: The illustrations applied in the manual may differ slightly from the actual device.
1.2 Safety Information
Contraindications
None
Conception of Warning, Caution an 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.
Note - Provides application tips or other useful information to ensure that you get the most from your product.

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Warnings!
• Before use, carefully read the manual.
• The wrist 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.
• The wrist 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.
• Do not use the device for treatment; we are not responsible for contretemps happened during
measuring.
• Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid.
The device is not intended for sterilization.
• Operation of the device may be affected by the use of an electrosurgical unit (ESU).
• Carefully route patient cables and connections to reduce the possibility of patient entanglement or
strangulation.
• Check the oximeter sensor application site every half an hour to determine the positioning of the sensor
and skin sensitivity of the patient.
• Do not use the wrist pulse oximeter in situations where alarms are required. The device has no alarms.
• Do not use the device under conditions of shocks and vibrations. Do not use it, either, with the patient
connected to such medical electrical equipment as a cardiac pacemaker and other electrical stimulators.
• Do not, under any circumstance, perform any testing or maintenance on the wrist pulse oximeter while it

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is being used to oximeter a patient.
• Products contain small parts; Keep the equipment away from children and pets.
• This equipment may cause allergy.
• This equipment is not intended for use during patient transport outside the healthcare facility.
• Do not use the wrist pulse oximeter in an MRI or CT environment.
• Explosion Hazard: Do not use the wrist pulse oximeter in an explosive atmosphere or in the presence of
ammable anesthetics or gases.
• Portable RF communications equipment should be used no closer than 30 cm (12 inches) to any part of
the equipment.
• Use of accessories, transducers and cables other than those specied 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.
• 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.
Cautions:
• Do not immerse the wrist pulse oximeter or sensors in any liquid.
• Do not place or pour liquids on the surface of the wrist pulse oximeter.
• Before cleaning or disinfecting the probe, unplug it from the oximeter to prevent probe or oximeter from

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being damaged, and to protect user under safety situation.
• The wrist pulse oximeter is a precision electronic instrument. It must be repaired by trained personnel
only.
• Ensure that the wrist strap ts comfortably on the patient’s arm. Do not over-tighten the wrist strap.
• This equipment complies with IEC 60601-1-2:2014 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.
• Please use accessories specied for this device and do not change them casually.
• The malfunction of probe or worn-out data cables may cause inaccurate measurement results, so the
user should check them frequently and make sure that they are in good working state.
• Follow local governing ordinances and recycling instructions regarding disposal or recycling of the unit
and unit components.
• The device is only for prescription use, federal law restricts this device to sale by or on the order of a
physician.
Notes:
• The performance of this device may be affected by the portable and mobile RF communications
equipment.

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• Application of this device in the background of electromagnetic areas may influence the measuring
accuracy such as in the environment of electro-surgery.
• SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the probe
area (with a surgical towel, for example) if necessary.
• Signicant levels of dysfunctional hemoglobin may affect the accuracy of the measurement.
• Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and
uorescein, may adversely affect the accuracy of the SpO2 reading.
• Any condition that restricts blood ow, such as use of a blood pressure cuff or extremes in systemic
vascular resistance, may cause a failure to determine accurate pulse rate and SpO2 readings.
• Remove fingernail polish or artificial fingernails before applying SpO2 probes. Fingernail polish or
articial ngernails may lead to inaccurate SpO2 readings.
• Optical cross talk can occur when two or more probes are located in adjoining area. It can be eliminated
by covering each site with opaque material. Optical cross talk may adversely affect the accuracy of the
SpO2 readings.
• Obstructions or dirt on the probe’s red light or detector may cause a probe failure. Make sure the probe
is clean.
• For routine equipment maintenance, please refer to the service procedures at the associated section as
indicated in the manual.
• Our company will only provide the schematic, components list, legend and correction details for the

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qualied technical personnel authorized by our company.
• As to the other concerns for attention, please carefully look through the specific chapter in this
instruction.
• This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
this device may not cause harmful interference and this device must accept any interference received,
including interference that may cause undesired operation.
• Pulse oximeter monitor has been validated and tested for compliance with this international standard
1.3 Intended Use
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended for measuring the
functional arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patients in hospital and home
care environment.
1.4 Electromagnetism Interference
This wrist pulse oximeter is designed and tested in compliance with the EMC standard, complying with 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, 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 device.

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This apparatus complies with the IEC 60601-1-2 international standard. The requirements of this international
standard are: CISPR11, GROP1, and CLASS B.
1.5 Explanation of Symbols
Symbol Meaning Symbol Meaning
%SpO2Hemoglobin Oxygen Saturation PR Pulse Rate
Type BF applied part IP33 Protected against dripping water
Attention, consult the accompanying
documents.
PR bpm
Serial number
Manufacture’s information Date of Manufacture
No SpO2Alarm Storage temperature and relative
humidity
Power button ? Indicate the signal is not stable
Low battery indication Follow instruction for use
European union approval Authorized representative in the
European community

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1.6 Product Features
 Compact in design, easy to wear;
 Touch screen, simple operation;
 Data storage, bluetooth transmission;
 Abnormal data, vibration reminder.

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2 General Description
The wrist pulse oximeter adopts OLED touch screen, which can display the SpO2, PR and PI value. It can also
provide information of date and time, remind you of the connection of Bluetooth®, probe or nger as well as
record your walk steps.
2.1 Appearance
Fig.2-1
Description of Fig.2-1:
1: OLED touch screen: display SpO2, PR and PI values, date & time, battery power, Bluetooth® connection.
2: Wrist
3: Power button: Press and hold the button for 3±1s to power the device on or off. Short press the button to

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turn on or off the screen when the device is powered on.
4: The probe socket/charging interface: to connect SpO2 probe for measurement and connect USB cable
for battery charging.
2.2 Power Supply
The MD300W628 wrist pulse oximeter is powered by lithium-ion rechargeable battery. The battery will typically
work for 10 hours in sleeping mode with the screen off.
Battery charging steps:
First, connect the device and the power adapter with the attached USB cable. The standard USB plug should
be connected to the power adapter and the other end of the USB cable should be connected to the probe
socket of the device.
Second, connect the power adapter into the power outlet.
In the charging process the screen will show "Charging". When the battery is full screen will show "Complete".
The typical charging time is less than 2 hours.
Fig.2-2

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Notes:
 Keep the device and power adapter away from source of re and/or heat;
 Do not touch the power adapter with your wet hands;
 The battery is not a detachable part, do not attempt to disassemble it;
 Charge the battery using specied chargers;
 Do not use the battery and power adapter in un-specied application.

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3 Take a Measurement
3.1 Power On
Press and hold "Power button" for 3±1s to start up the device.
The display screen will be highlighted when powered on (see Fig.3-1).
Then the screen will show a time and a date (see Fig.3-2).
Swipping the screen left and right to switch the interfaces.
Fig.3-1 Fig.3-2
3.2 Probe Installation
1. Plug the SpO2 probe into the probe socket of the Wrist Pulse Oximeter, ensure that the sensor is plugged
correctly and rmly (see Fig.3-3).
Fig.3-3
NOTE: Be sure to insert the sensor correctly, otherwise there will be no signal detected.

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2. Place the patient’s nger inside the sensor as shown in Fig.3-4.
Fig.3-4
3.3 Take a Measurement
i Swipe the creen left to enter the measurement interface, as the Fig.3-5, the values will be horizontal lines "-"
before the results show.
Fig.3-5
ii Then the measurement result will display as in Fig.3-6. Read the measured SpO2 value, PR and PI values

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from the screen. Swipe the creen left, you can check your walk steps, see Fig.3-7
Fig.3-6 Fig.3-7
Description of measurement screen:
98 : %SpO2value
79 : PR value
3.6 : PI value
: Pulse waveform
: Battery power indication.
A low battery indication may be displayed, when the remaining power capability is insufcient.
The device will automatically shut down when the battery voltage is lower than 3.5V + 0.1V.
: The Bluetooth® indicator: The indicator keeps lighted for Bluetooth® working mode, but flashes if no
device connection.
? : If the screen displays “?”, it means the signal is unstable, please keep your hands still and retry.
Note:

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If the probe is inserted into the pulse oximeter but no nger is placed, “Finger Out” will appear on the screen
(Fig.3-8). If there is no probe inserted after power on, “Probe Off” will appear on the screen (Fig.3-9).
Fig.3-8 Fig.3-9
iii Switch measuring modes:
The device will default to real-time measurement each time you power it on. Swipe down from the top on
any screen and tap on the screen as shown in Fig.3-10, the device will switch to "sleeping mode" and the
Bluetooth® will break. The measurements will also be recorded.
Fig.3-10
Factors that may affect the measurement

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During operation, the accuracy of oximetry readings can be affected by the following factors:
(1) Instrument performance depends on the pulsatile character of the artery. The measurement would not be
considered reliable and accurate if the following conditions take place during measurement.

Shock or cardiac arrest

Temperature beyond the limit

After the administration of a cardiovascular drug

Anemia

Evidence of ventilation-perfusion mismatch
(2) Instrument performance depends on the wavelength absorption for oxyhemoglobin and deoxyhemoglobin.
If there are substances absorbing the same wavelength, this would induce false or low SpO2 values. The
following may affect these values:

carboxyhemoglobin

methemoglobin

methylene blue

Indigo carmine
(3) Extremely high illumination could affect the SpO2 measurement. Use a semi-translucent or opaque cover to
shield the sensor.
(4) Other factors
a) High-frequency electrosurgical interference from external units, including debrillators.
b) Placement of a sensor on an extremity that currently has been placed a blood pressure cuff, arterial