Beijing Choice Electronic Technology MD300K3 User manual

V1.0K3 PULSE OXIMETER INSTRUCTION MANUAL
0
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confidential work. We may also seek to maintain this work as an unpublished copyright.
This publication is to be used solely for the purpose of reference or operation of our device.
No part of this work can be disseminated for other purposes.
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for errors contained herein nor for incidental or consequential damages in connection with
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to is protected by copyrights or patents and does not convey any license under the patent
rights of our company, nor the rights of others. We do 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.
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V1.0K3
Issue date: 13th October, 2010

V1.0K3 PULSE OXIMETER INSTRUCTION MANUAL
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Contents
1 Introduction............................................................................................. 2
1.1 Brief Introduction................................................................................................2
1.2 Safety Information ..............................................................................................2
1.3 Intended use........................................................................................................4
1.4 Electromagnetism Interference.........................................................................4
1.5 Explanation of Symbols.....................................................................................5
1.6 Product Features ................................................................................................5
2 General Descriptions.............................................................................. 6
2.1 Appearance .........................................................................................................6
2.2 Rear Panel ...........................................................................................................9
2.3 Power Supply......................................................................................................9
3 Install SpO2Probe................................................................................. 11
4 Setting ID, Date and Time..................................................................... 12
4.1 Date & Time Settings........................................................................................12
4.2 ID number Setting.............................................................................................13
5 Take a Measurement............................................................................. 14
6 Other Settings ....................................................................................... 17
6.1 Alarm Setting.....................................................................................................17
6.2 Data Management .............................................................................................18
6.3 System Setting..................................................................................................22
7 Maintain and Repair.............................................................................. 25
7.1 Maintenance......................................................................................................25
7.2 Safety Checks ...................................................................................................25
7.3 Calibration and Verification .............................................................................27
7.4 Trouble Shooting ..............................................................................................28
7.5 Warranty and Repair.........................................................................................28
7.6 Storage and Transportation.............................................................................30
APPENDIX A Specifications.................................................................... 30

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1 Introduction
1.1 Brief Introduction
Thank you for purchasing the pulse oximeter. The main functions of the device include
Haemoglobin Saturation (SpO2) and pulse rate (PR) measurements, visual and audible
alarm, batteries charging, data storage and review, USB cable and Bluetooth®for data
transmission, etc. Please read this manual carefully before using the device.
Note: The illustrations applied in the manual may differ slightly from the actual unit.
1.2 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.
¾Warning - Indicates a potential hazard or unsafe practice that, if not avoided, will
result in death or serious injury.
¾Caution - Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
¾Note - Provides application tips or other useful information to ensure that you get
the most from your product.
Warnings
zUsers should follow all instructions listed in this manual. Our company will assume no
warranty for using this equipment improperly.
zDo not use the oximeter in the presence of flammable anesthetics, vapors or liquids.
zDo not use the oximeter in an MRI or CT environment.
zThis equipment is intended only as an adjunct in patient assessment, and the
measurement results only serve as a reference for any relevant treatment.
zConnect the probe correctly; please see the directions for use of any accessories.
zProlonged use of the probe/sensor or the patient’s condition may require changing the
sensor site periodically. Change the sensor site and check skin integrity, circulatory
status, and correct alignment at least every 4 hours. Prolonged use may cause blisters,

V1.0K3 PULSE OXIMETER INSTRUCTION MANUAL
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skin deterioration, and discomfort.
zWhen 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
950 and IEC 601-1-1. Any input/output device should follow the protocol of IEC
601-1-1.
zThe malfunction of probe or worn-out data cables may cause inaccurate measurement
results, so the user should inspect them frequently and make sure that they are in good
working state.
zDo not touch the AC adapter with wet hands, otherwise, you may suffer electric shock.
zThe disposable accessories should not be cycled.
Cautions
zClean the probe with an H2O solution and a neutral detergent.
zDon’t submerge the probe into any liquid. Do not use in autoclave (sterilizer).
zBefore cleaning or disinfecting the probe, unplug it from the oximeter to prevent probe
or oximeter from being damaged, and to protect user under safety situation.
zTo avoid an electrical hazard, never immerse the unit in any liquid or attempt to clean it
with liquid cleaning agents. Always disconnect the device from AC adapter before
cleaning.
zAlarm must be set up according to different situations of individual patient. Make sure
that alarm sound can be activated when alarm function begins to work.
zThe materials that contact with human bodies are all non-toxic.
Notes
zApplication of this device in the background of electromagnetic areas may influence the
measuring accuracy such as in the environment of electro-surgery.
zSpO2measurements may be adversely affected in the presence of high ambient light.
Shield the probe area (with a surgical towel, for example) if necessary.
zDyes introduced into the bloodstream, such as methylene blue, indocyanine green,
indigo carmine, and fluorescein, may adversely affect the accuracy of the SpO2
reading.
zAny condition that restricts blood flow, such as use of a blood pressure cuff or extremes
in systemic vascular resistance, may cause a failure to determine accurate pulse rate
and SpO2readings.

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zRemove fingernail polish or artificial fingernails before applying SpO2probes.
Fingernail polish or artificial fingernails may lead to inaccurate SpO2readings.
zOptical 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 SpO2readings.
zObstructions or dirt on the probe’s red light or detector may cause a probe failure.
Make sure there are no obstructions and the probe is clean.
zThe AC adapter and accessories used with the device should be complied with the
requirement of IEC60601-1.
zFor routine equipment maintenance, please refer to the service procedures at the
associated section as indicated in the manual.
zDispose of the device or its accessories end of life in accordance with the local
ordinances and regulations, otherwise, discarding them as you like may cause
pollution to the environment.
zIt is not recommended to take measurements during battery charging.
zOur company will only provide the schematic, components list, legend and correction
details for the qualified technical personnel authorized by our company.
zThe device is only for prescription use, federal law restricts this device to sale by or on
the order of a physician.
zAs to the other concerns for attention, please carefully look through the specific chapter
in this instruction.
1.3 Intended use
The MD300K3 handheld pulse oximeter is a portable, non-invasive device intended for
continuous monitoring, spot checking of functional arterial oxygen saturation(SpO2) and
pulse rate of adult and pediatric patients in hospital and home care. The application site
are fingers.
1.4 Electromagnetism Interference
This 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

V1.0K3 PULSE OXIMETER INSTRUCTION MANUAL
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levels of such interference due to close proximity or strength of a source, may result in
disruption of performance of this device.
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 Explanation Symbol Explanation
Type BF applied part IPX1 Protected against dripping
water
ID indication Battery power indication
Audible alarm on Audible alarm inhibition
Pulse Beep on Pulse Beep off
Keyboard is unlocked Keyboard is locked
USB cable is
connected. USB cable disconnected
SpO2probe is inserted SpO2probe off
Bluetooth®activated Bluetooth®inactivated
SD card is inserted The adapter is connected
Printer The SD card socket
Alarm inhibition Power on/off
Prevent from rain SN Serial number
Storage temperature
and relative humidity Attention, consult the
accompanying documents.
Date of Manufacture Manufacturer’s information

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1.6 Product Features
Simple to use and easy to operate.
Portable and compact in design.
TFT display screen with adjustable backlight.
Up to 127 patients’ ID and 72-hour records can be saved.
Visual and three-level audible alarms, low battery power alarm.
Data transfer to PC by USB cable or Bluetooth®.
Powered by four AA alkaline/Ni-MH batteries/power adapter.
Battery charge function with adapter (optional).
Suitable for adult and pediatric patients.
2 General Descriptions
The pulse oximeter adopts 2.8 inch TFT screen, which can display the SpO2% and pulse
rate value, other indication parameters, such as time, ID number, pulse bar and battery
power status, alarm limits and the connection of probe, etc.
2.1 Appearance

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Fig.2-1
Description of Fig.2-1：
(1) Fixing clip for the SpO2probe.
(2) Displaying screen.
(3) Print Button: Press this button to turn on/off the function of printing.
(4) OK Button: Press this button to enter menu items or confirm the
selection/setting.

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(5) Up Button: Press this button shortly to increase the value by one unit. You
can press and hold the button extendedly to speed up the adjustment of values.
(6) Alarm inhibition button: Press this button to close alarm sound for 120
seconds. You can open the alarm sound in the process of alarm inhibition by pressing
the button again.
(7) Down button: Press this button shortly to decrease the value by one unit.
You can press and hold the button extendedly to speed up the adjustment of values.
(8) Return/Lock button: On the measuring screen, it serves as Lock button. You
can lock the keyboard by long pressing it and press it again to unlock; On the menu
and sub-menu screen, it serves as Return button.
(9) Power button: Press and hold it for about 3 seconds to power the device on,
and for about 4 seconds to turn the device off.
(10) Adapter socket: For connecting the power adapter.
(11) Paper Feed button: When the printing function is turned on, you can press the
button to start printing.
(12) SpO2socket: For connecting the SpO2probe with the oximeter and connecting
USB cable with your computer for data transmission.
(13) micro SD: The socket for installation of the SD memory card.
(14) USB socket: It is designed to update the software of the device and only serves
engineers.
(15) Speaker: The speaker for alarm and beep, its volume can be adjusted.
(16) Alarm lamp/ Charge indicator: When SpO2or/and PR alarm occurs, it flashes in
yellow. When the unit is being charged, the lamp will flash in green; when it is
charged to full, the lamp will keep light without flashing.
Notes:
When the keyboard is locked, all the keys will be inactivated.
You can set auto power-off mode through system setting.
The SpO2socket and data transmission share a common interface, so you
can’t take a measurement when the unit is uploading data to PC.
You should refer to the corresponding chapter about the specific operation of
printing.

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2.2 Rear Panel
(1) Paper Feed button: when the printing function is on, press this button you can start
printing.
(2) Outlet: the outlet for printing paper.
(3) The groove for installing the printing paper.
(4) The cover of battery compartment.
Fig.2-2
2.3 Power Supply
The device can be powered by 4 AA alkaline batteries, Ni-MH batteries or power adapter.
2.3.1 Powered by batteries
Batteries Installation:
1) Open the battery cover and you can see the battery polarities as shown in Fig.2-3.
2) Install 4 AA alkaline batteries (or 4 AA Ni-MH batteries) lightly as indicated by the
polarity signs in battery compartment.

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Fig.2-3
Warnings!
DO NOT USE Ni-MH rechargeable and alkaline batteries together, otherwise,
that may damage the device or injury users.
Make sure the polarities of the batteries are correct.
3) Close the battery cover.
Battery life
When the battery power is lower than 4.5V±0.1V the battery indicator will become empty
and at the same time its frame will become red, which means little of battery capacity
remains. You should replace the batteries with new ones in time.
The unit will shut down when the battery voltage is lower than 4.4V±0.1V.
Cautions!
Do not use batteries not specified for this unit.
Do not dispose of batteries in fire.
If battery fluid gets on your skin or clothing, rinse with plenty of clean water
immediately.
Remove the batteries from this unit when you are not going to use it for a long
period of time (approximately one month).

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Do not use batteries of different types together.
Do not use new and used batteries together.
Dispose of batteries in accordance with the local ordinances and regulations.
Regular maintenance of rechargeable batteries is required, such as periodic charge
and discharge.
The charging time shouldn’t be too long, otherwise, it may reduce batteries
performance and shorten batteries’ life.
2.3.2 Charging Batteries through adapter (optional)
To charge batteries, please ensure the installed batteries are Ni-MH ones. Firstly connect
the adapter with the oximeter and secondly with the wall outlet, and then press and hold
the power switch for 3 seconds to power the device on.
A prompt window will appear inquiring you “Are the batteries Ni-MH ones?”. Select “Yes”
to charge them by wall outlet or “No” to abandon charge.
Notes:
1. To avoid the device from being damaged due to shot circuit, please make sure the
adapter is firstly connected with the oximeter and secondly with the wall outlet. While
disconnected the connection, please make sure the adapter is firstly disconnected from
the wall outlet and then disconnected from the oximeter.
2. During battery charge, the “Power Auto” and “Brightness” items can not be accessible.
3. It is not recommended to take a measurement during the oximeter is powered by wall
outlet or being charged, for damages and injuries may be caused to the device or users.
4. DO NOT charge when the non-rechargeable batteries are installed, otherwise damages
or injuries may be caused to the device or users.
5. You can cut off the power of the device through unplug the adapter.
6. It is not recommended to charge batteries while the battery power is sufficient. If you
perform the charging action at this time, the device will detect the battery voltage and
terminate the charging automatically to protect the batteries. In this case the prompt
window will not appear.
3 Install SpO2Probe
Set the fixing clip for SpO2probe, and then insert the SpO2probe to the SpO2socket as

V1.0K3 PULSE OXIMETER INSTRUCTION MANUAL
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shown in Fig.3-1. When the SpO2probe is connected well, please set the fixing clip up to
ensure the probe well connected.
Fig.3-1
The indicator will be shown on the display screen when the probe is well connected. If
the probe is disconnected from the unit, the indicator and the prompt “Probe Off！！！”
will appear in the status column.
The socket is also used for USB cable connected with the PC for data transmission. For
more information on data transmission and data management, refer to the corresponding
software instruction manual.
4 Setting ID, Date and Time
Always set the date and time before using the unit for the first time. Set different ID
numbers for different users.
Check the date and time are correct before using the unit, and reset them if necessary.
The date and time are important indicators when a measurement is taken.
4.1 Date & Time Settings
Set the correct time according to the following steps:
1) Press the power switch for 3 seconds to power on the oximeter and then press the
menu button to enter the main menu, refer to Fig.4-1.

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Fig.4-1
2) Press the Down button to select the “Date and Time” item, and then press the Menu
button to enter the time setup screen, refer to Fig.4-2.
Fig.4-2
Pick different sub-items to set and press the OK button to highlight it and then using the
Up or Down button to adjust the value. At last, press the OK button to confirm your
settings.
4.2 ID number Setting
Enter the “User ID Setting” item from the main menu screen, refer to Fig.4-3. Press the OK
button to make the “User ID number” highlighted, and then press the Up or Down button to
increase or decrease the ID number, and then press the OK button again to confirm your
settings. The range of ID number is: 001-127.
Note: The user ID cannot be changed; you may get the prompt information saying

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that “Cannot change!!!”, if you attempt to change it when taking a measurement.
Fig.4-3
5 Take a Measurement
Warnings!
zThe measurement would not be performed if the following instances come across
in operation:
zShock
zLow temperature of hand
zHave taken vascular activity medicine
zAnemia
zcarboxyhemoglobin
zmethemoglobin
zmethylene blue
zIndigo carmine
zOnly use the SpO2probes provided by the manufacturer, other SpO2probes may
cause improper performance.
zDo not use the SpO2probe with exposed optical components.
zExcessive patient movement may cause inaccurate measurements.
zTissue damage can be caused by incorrect application of the probe, for example
by wrapping the probe too tightly. Inspect the probe site to ensure skin integrity
and correct positioning and adhesion of the probe. More frequently inspection
should be taken depend on different patients if necessary.
zInaccurate measurements may be caused by:
zSignificant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or
methemoglobin);
zIntravascular dyes such as indocyanine green or methylene blue;
zExposure to excessive illumination, such as surgical lamps (especially ones with a

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15
xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight;
zHigh-frequency electro surgical interference and defibrillators;
zVenous pulsations;
zPlacement of a probe on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line;
zThe patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia;
zThere is arterial occlusion proximal to the probe;
zThe patient is in cardiac arrest or shock.
zLoss of pulse signal can occur in any of the following situations:
zThe probe is too tight
zThere is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight
zA blood pressure cuff is inflated on the same extremity as the one to which an SpO2
probe is attached
Note：SpO2probe should obviate the light source, e.g. radial lamp or infrared lamp.
Before taking a measurement:
zSelect a suitable probe in terms of type and dimension.
zPlug the probe into the SpO2socket on top of the pulse oximeter.
zClip the patient finger to the rational position of the probe as the illustration as Fig.5-1.
Fig.5-1 Placement of the probe
Note: If no finger is in the probe, the words “Finger Out!!” will be shown.
There are two display modes as shown in Fig.5-2&5-3.

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Fig.5-2Digitaldisplay Fig.5-3Wavedisplay
Status bar 1: The status of the oximeter is shown on the bar (Measure… , Finger
out!!, Probe off!! and so on).
Status bar 2: If the measured SpO2% or PR value exceeds the alarm limits, there will
be corresponding information.
SpO2%: SpO2area of display
◆It shows the oxygen saturation level of functional hemoglobin during normal
measurement.
◆The color of the SpO2value will become red when the SpO2value exceeds the
alarm limits.
◆It shows two dashes throughout probe off and finger out conditions.
100: SpO2% high alarm limit indicator; 90: SpO2% low alarm limit indicator.
Pulse amplitude bar:
It indicates the dynamic pulse amplitude and rate. As the detected pulse becomes
stronger, more bars are illumined with each pulse. The reverse is true for weak
pulses.
100: PR high alarm limit indicator; 60: PR low alarm limit indicator.
PR: PR area of display
◆It shows the pulse rate in beats per minute during normal measurement.

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◆The color of the PR value will become yellow when the PR value exceeds the
alarm limits.
◆It shows three dashes throughout probe off and finger out conditions.
15:00: The current time.
6 Other Settings
6.1 Alarm Setting
From the main menu, select and enter the “Alarm setting” screen, refer to Fig.6-1.
1) SpO2alarm setup
To set SpO2alarm high limit in the “Alarm setting” screen, press the Up or Down button to
select the “High limit（SpO2）”. And then press the OK button to highlight the item. Press
the Up or Down button to adjust its value, and then press the OK button again to confirm
the setting of SpO2high limit. The range of SpO2high limit is 71%-100%.
Fig.6-1
Set the low limit for SpO2alarm as the above steps of SpO2high limit settings. The range
of SpO2 alarm low limit is 70%-99%.
2) PR alarm setting
The limits settings of PR are performed as similarly as the SpO2limits. The range of High
limit is 31bpm-235bpm, the range of low limit is 30bpm-234bpm.
3) Alarm on/off
In the Alarm Setting screen, press the Up or Down button to select the Alarm (SpO2or PR)
sub-item, and press the OK button to highlight it. Then press the Up or Down button to
select ON or OFF. And at last press the OK button to confirm your setting. If you set the
SpO2and/or PR alarm off, the corresponding limits on the measurement display is crossed

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with “×”.
Note: Please caution the alarm off item, it may cause damages to users.
ALARM PRIORITY
Alarms of the oximeter include technical and physiological alarms. All the three priorities
are divided by built-in module and can not be changed by users.
High priority: indicates the patient is in the very dangerous situation.
Medium priority: indicates the warnings should be paid attention to.
Low priority: indicates the technical alarm caused by the device itself.
Assignment of priority:
High Medium Low
Paramter SpO2PR
Value Red Yellow
Alarm lamp Flashing with yellow Flashing with yellow
Lamp
Frequency 1.5Hz 0.5Hz
Audiblesound Di- Di – Di ----- Di - Di Di - Di - Di Di
Alarm cycle 3 s 5 s 20 s
Alarm info SpO2too high/low PR too high/low Probe off/Finger out
AUDIBLE ALARM INHIBITION:
Short press the button to silence the audible alarm for 120 seconds, the audible
alarm indicator will be displayed as , together with the countdown from 120s to 0s,
short press it again, you can cancel alarm inhibition.
Warnings!
When an alarm occurs, check patients’ conditions immediately.
zCheck which parameter is alarming or which alarm is going on.
zCheck patient’s condition.
zSearch for the source of alarm.
zMake the alarm mute if necessary.
6.2 Data Management
From the main menu screen, select and enter the “Data Manage” screen, refer to Fig.6-2.
The unit can store 72-hour records. If the storage is full you should delete the old records

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manually for free space.
Fig.6-2
6.2.1 Data Review
Pick and enter the “Data Review” sub-item, the screen as shown in Fig.6-3 will appear.
You can move the rolling bar to view all the records that have saved in the unit by pressing
the Up or Down button.
Press the OK button, a dialog box will pop up, refer to Fig.6-4. After selecting a ID number,
press the Up or Down button to select “Delete” or “Review” and then press the OK button
to confirm, you can delete or review all the records saved under this ID.
Fig.6-3 Fig.6-4
6.2.2 SpO2Trend
Pick and enter the “SpO2Trend” sub-item, and the screen as shown in Fig.6-5 will appear.