ChoiceMMed MD300K User manual

Contents
CHAPTER 1 INTRODUCTION……………………………2
1.1 Brief Introduction……………………………………………….2
1.2 Safety Information……………………………………………2
1.3 Electromagnetism Interference………………………………5
1.4 Equipment Classification……………………………………5
1.5 Accessory……………………………………………………5
CHAPTER 2 General Descriptions ……………………….....6
2.1 Front panel………………………………………………6
2.2 Rear panel……………………………………………………7
2.3 Product feature…………………………………………………8
2.4 Scope application……………………………………………8
CHAPTER3 Install the batteries and the sensor………….....8
CHAPTER 4 ID, Date and time Setting…………………10
CHAPTER 5 Take a measurement……………………………10
CHAPTER 6 History Data reviewing……………………........13
CHAPTER 7 ID setting……………………………...................14

VER.1.3 PULSE OXIMETER OPERATOR＇S MANUAL
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CHAPTER 8 Alarm setting…………………………….............14
CHAPTER 9 Beep on/off………………………………………18
CHAPTER 10 Maintain and repair……………………………18
APPENDIX A: Specifications…………………………23
APPENDIX B: Guidance and manufacture's declaration
- electromagnetic immunity……………………….24

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1 INTRODUCTION
1.1 Brief Introduction
Thank you for using the handheld pulse oximeter. The main function of
the device is to measure SPO2 and PR, visual and audio alarm, sensor
off alarm, data storage and replay etc. Please read the operator's
manual carefully before using it.
1.2 Safety Information
Conception of Warning, Precaution and Notice
The Warning, precaution and Notice at this document are special
information in favor of users operation.
Warning★
Indicate that maybe some potential hurt or damage to patients.
Precaution★
Make user must take a serious attitude to the incorrect operation, which
are likely to incur some life-threatening incidents.
Notice★
Serve as a pivotal notice to avoid preventable incidents during
application of this equipment.
Warnings
zThe handheld pulse oximeter should be confined to sophisticated
operator exclusively. Prior to application, we strongly suggest you
should follow instructions listed in this document, or any wrong-doing
operation which causes serious damage will take full responsibility
for this. Our company will assume no warranty for using this
equipment improperly.
zDo not close to liable flammable matters, spark in case of
unexpected explosion.
zDo not apply this equipment at such environment as magnetic
resonance imaging (MR or MRI) equipment which is the source of
some electric noise to influence the accuracy of this equipment and
following treatment.
zMake sure to apply this equipment for medial sphere, and gauging
results only serve as a reference for any relevant treatment.
zPlease cautiously use this equipment for too long time, It is
necessary for you to protect yourself from avoidable injury.

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zWhen placing sensor in right place, please see to it that strict work
instructions must be due, for example do not extend tape or fix it too
tightly.
zWhen begin to gauge associated body features please follow the
doctor’s counseling.
zWhen connecting this equipment to any instrument, verify proper
operation before clinical use. Refer to the other device’s manual for
full instruments. Accessory equipment connected to the oximeter’s
data interface must be certified according to IEC Standard 950 for
data-processing equipment or IEC Standard 601-1 for electromedical
equipment. All combinations of equipment must be in compliance
with IEC Standard 601-1-1 system’s requirements. Anyone who
connects additional equipment to the signal input port or signal
output port configures a medical system and is therefore responsible
that the system complies with the requirements of system standard
IEC Standard 601-1-1.
zConsidering the sensor is a sensitive device so please strictly follow
the sensor application instructions.
zThe malfunction of sensor may cause inaccurate data which serve as
a foundation to treat patients, so make pay more attention to the
sensor and inspect it more usually.
zThe worn-out data cables may cause inaccurate data and used as a
reference to treat patient, so must pay attention to data cable and
check it more frequently.
zThe disposable peripheral should not be cycled.
Precautions
zRinsing the sensors with ethylene oxide solution may have adverse
influence on the machine, Apart from this, should not autoclave or
submerge the sensor.
zThis device is intended for use by persons trained in professional
health care. The operator must be thoroughly familiar with the
information in this manual before using the device.
zUnplug the sensor from the monitor before cleaning or disinfecting to
prevent sensor or monitor from being damaged, and to prevent user
under safety situation.
zAlarm must be set up according to different situation of individual
patient. Make sure that chime sound can be activated when alarm

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function begin to work.
Notices
zApplication of this device may influence the measuring accuracy in
the background of electromagnetic areas such as electro-surgery
environment.
zOperation of this device may be adversely affected in the presence of
computed tomography (CT) equipment. Use only BCI SpO2 sensors
supplied with, or specifically intended for use with, this BCI device.
Use of sensors not intended for use with this device may cause
inaccurate readings. Pay more attention to the application when
apply this device under the situation of computed tomography (CT)
environment. Please exclusively use the attached accessory, BCI
SPO2,
zSpO2 measurements may be adversely affected in the presence of
high ambient light. Shield the sensor 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 SpO2 readings.
zRemove fingernail polish or artificial fingernails before applying SpO2
sensors. Fingernail polish or artificial fingernails may lead to
inaccurate SpO2 readings.
zSpO2 averaging is the number of pulse beats over which the SpO2
value is averaged; pulse averaging is the number of seconds over
which the pulse value is averaged.
zHazards arising from software errors have been minimized. Hazard
analysis conforms to meet ISO14971: 2000 and EN60601-1-4: 1996.
Significant levels of dysfunctional hemoglogins, such as
carboxyhemoglogin or methhemoglobin, will spawn an affection of
the accuracy of the SpO2 measurement.
zOptical cross-talk can occur when two or more sensors 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.

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zObstructions or dirt on the sensor’s red light or detector may cause a
sensor failure. Make sure there are no obstructions and the sensor is
clean.
zFor routine equipment maintenance, please refer to the service
procedures at the associated section as indicated in the manual.
zAs to the other concerns for attention, please carefully look through
the specific chapter in this instruction.
1.3 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 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
1.4 Equipment classification
1.5 Accessory
1. Two AA batteries
2. One operator’s manual

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3. One adult finger sensor: compatible with BCI
Optional accessory:
1. Finger sensor for pediatric and infant: compatible with BCI
(Pediatric 15-45 Kg, Infant 3-15 Kg)
2. Finger sensor for neonate: compatible with BCI (Neonate<3kg)
3. Data cable
4. Software for data transmission.
2 General Descriptions
The handheld pulse oximeter adapts 8-segment digital LED as
indication. It can display the SPO2 and pulse rate value, all kinds of
parameters, such as time & date, ID number, as well as pulse bar
battery status etc.
2.1 Front panel:
Please refer to Fig 1. The figure is initial display mode.
Fig1Front panel

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Instruction of figure 1：
□1 SPO2：SPO2 value（displaying value is 98% now）
□2 PR：Pulse rate（displaying value is 76 bpm now）
□3 ：Low power indication. When the power is lower than 2.4V, this
sign will be lighted. And the oximeter will power off automatically
when the power is lower than 2.3V.
□4 Alarm Indication：When technical alarm or physiological alarm
occurs, the light on the sign will turn red.
□5 Power on button
□6 Navigation buttons: you can select and set the different parameters.
□Shortcut key: key: press the up key, the unit will display the ID
number. key: press the right key, the unit will display the Error
number.
□7 Menu button: You can return to the measurement picture or switch
the main menu item by this button.
□8 Reserved function.
□9 Beep off/on Indication: When beep voice off, the LED on.
□10 Alarm light: When there is an alarm or indication, the relative light
on the sign will be light.
□11 Pulse bar：The pulse bar is proportion to the Pulse volume.
Note: According to the customs orders, not all the pulse oximeter
with all the functions listed above.
2.2 Rear panel

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Fig.2
Rear panel introduction:
1: Battery box
2: Fixing hole
3: Battery box cover
4: Fixing screw
2.3 Product features:
Rubber grip design offers special protection
Compact, lightweight design for simple, one-hand operation
High brightness LED display SpO2, pulse rate and pulse bar.
Up to 100 patients’ ID and 72-hour record storage
Visual & audio alarm, low battery alarm
Data transfer to PC for storage or printing
Convenient 2 AA size alkaline batteries
Suitable for adult, pediatric and neonatal patient
2.4 Scope application:
The purpose and function of the handheld pulse oximeter is to spot
check or monitor %SpO2 and pulse rate for adults, pediatric and
neonate patients in all hospital areas. It can help the doctor and nurse
know the patient’s %SpO2 and pulse rate rapidly, and stored the 72
hours data.

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3 Install the batteries and the sensor
3.1 Install the batteries as the following pictures:
1）Open the battery cover: Rotate the fixing screw slightly in the rear
panel to the upright position which is marked with “ ” and then open
the cover with nail.
Fig.3
2) Install two batteries lightly as indicated by the polarity sign:(refer to
Picture 4）
Note: Make sure the polarity of the batteries is correct
3) Close battery cover
Close the battery cover and rotate the screw to the position. And the
battery is locked.
Make sure that the polarity of the batteries is correct.
Otherwise the unit cannot operate normally.
Battery life and replacement
When the low power indication light please replace the batteries with
new ones timely.
Always turn the unit off before replacing the batteries.
Dispose of the used batteries according to the applicable local
regulations.
Fig. 4

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Warnings!
If battery fluid should get in your eyes, immediately rinse with plenty of
clean water. Consult a doctor immediately.
Caution!
Do not use batteries not specified for this unit. Do not insert the
batteries with the polarities in the wrong direction.
Do not dispose of batteries in fire.
If battery fluid should get on your skin or clothing, immediately rinse
with plenty of clean water.
Remove the batteries from this unit when you are not going to use it
for a long period of time (approximately three month or more).
Do not use batteries of a different type together.
Do not use new and used batteries together.
3.2 Install the sensor as the following pictures:
Fig.5
Insert the SpO2 sensor to the socket.
4 Setting ID, Date and time
Always set the date and time before using the unit for the first time.
Set different ID number for different user.
Check the date and time are correct before using the unit, reset them if
necessary. The date and time are important indicators when a measurement
is taken.

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4.1 Date & Time Setting
Press the menu key three times under the interface of initial display
mode to enter time setup, and then press the left or the right button to
select different data & time parameters, parameter will be displayed in
the following order.
: It means the minute. The setting range is: 0-59
: It means the hour. The setting range is: 0-23
: It means the date. The setting range is: 1-31
: It means the month. The setting range is: 1-12
: It means the year. The setting range is: 0-20
Press up or down key to your suitable value.
Minute setting for example:
1) Press the power button to turn on the unit.
2) Press the menu button for four times to enter
into the time setting picture shown as fig.6:
press the up or down button to set the
suitable year, and then press the left or
the right button to enter into the other date and
time parameters setting pictures.
4.2 ID number Setting
In initial display mode press up key, the number
LED shows ID number, after 3 seconds, it will
back to initial display mode automatically.
After power on, press the menu button for two
times you can enter into the ID setting picture.
Press the up or down button to set the
ID number and then press the menu button to
confirm your selection and enter into other parameter setting picture. It
will turn to the normal measuring picture if there is no button pressed for
one minute. The setting range of ID number is: 0-127
Fig. 7

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5 Take a measurement
After finishing the time and the ID number setting, plug your finger into
the sensor shown as the following picture:
Fig 8 placement of the sensor
zSelect the suitable sensor in terms of type and dimension.
zClip the sensor to the rational position of the patient finger
zPlug sensor into SpO2 port on top panel of pulse
oximeter.
Description of Fig.9:
SPO2: SPO2 value （displaying value is 98%
now）
PR：Pulse rate（displaying value is 67 bpm now）
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
Fig.9

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zUse only SPO2 sensors provided by manufacturer for SPO2
measurements. Other SPO2 sensors may cause improper
performance.
zDo not use an SPO2 sensor with exposed optical components.
zExcessive patient movement may cause inaccurate
measurements.
zTissue damage can be caused by incorrect application or use of
sensor, for example by wrapping the sensor too tightly. Inspect
the sensor site to ensure skin integrity and correct positioning
and adhesion of the sensor. More frequently inspection should
be taken depend on different patients if necessary.
zSet the upper limit of SPO2 alarm to 100% means cut off the
upper alarm. High density of oxygen will cause adverse
affection to the neonate .So the upper limit of SPO2 alarm must
be selected prudently according to the acknowledge clinical
practice.
zInaccurate measurements may be caused by:
zIncorrect sensor application or use
zSignificant levels of dysfunctional hemoglobins (such as c
arboxyhemoglobin or methemoglobin)
zIntravascular dyes such as indocyanine green or methylene blue
zExposure to excessive illumination, such as surgical lamps
(especially ones with a 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 sensor 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 sensor
zThe patient is in cardiac arrest or is in shock
zLoss of pulse signal can occur in any of the following situations:
zThe sensor 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 sensor is attached

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Note：Pulse sensor should obviate the light source, e.g. radial
lamp or infrared lamp.
6 History Data reviewing
6.1 Character Definition:
: The user’s SpO2.
: The user’s pulse rate.
: The user’s ID number.
: The minute of the history data.
: The hour of the history data.
: The date of the history data.
: The month of the history data.
: The year of the history data.
6.2 Reviewing operation:
In the measuring picture press the menu button for
one time you can enter into the data reviewing
picture shown as the Fig 10. And then press the
up or down button, you can review the last
user’s SpO2, PR, ID and the minute, hour, data,
month and year of measuring. The measuring data
is recorded every four seconds, so press the right
or left button, you can get the data of other
four seconds.
7 ID setting
Please refer to the “4 Setting ID, Date and time”
CAUSION: If user wants to save the measurement value, should setup
the ID number first.
WARNING!
zIf user wants to save the history measurement value, should setup ID
number first.
zThe ID number is from 0-127, If change a patient, user should setup
a new ID number to part the last patient
Fig.10

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8 Alarm setting
8.1 ALARM PRIORITY
There are there-level priorities for selection.
High priority: the highest level alarm, indicate the patient is in the very
dangerous situation.
Medium priority: indicate the warning should be paid attention.
Low priority: indicate the measuring value beyond the preset limitation.
Alarm of this oximeter includes technical and physiological alarm. All
three priorities divided by built-in module and can not be changed by
user.
VISUAL ALARM INDICATORS:
If the alarm is activated through over limitation of physiological alarm,
corresponding data area is flashing. If the alarm is activated by more
than one physiological alarm, each parameter will be displayed with
flashing.
AUDIBLE ALARM INDICATORS:
Audible alarms can be heard if there is no silence. The audible alarm
has different tone pitch and on-off beep patterns for each alarm priority.
High priority: "du-du-du-------------du-du”, beeps every 8 seconds.
Medium priority: "du-du-du", beeps every 5 seconds.
Low priority: "du-”, beeps every 5 seconds.
8.2Character Definition:
: High alarm of SpO2
: Low alarm of SpO2
: High alarm of pulse rate
: Low alarm of pulse rate
:Turn on or turn off the Alarm
8.3 SpO2 alarm setting:
SpO2 high alarm: Turn on the oximeter and
press the menu button for three times, and you will
enter into the following picture of high alarm of
SpO2. Press the up or down button to set
the data, and press the right button to set other
Fig.11
Fig.12

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alarms or press menu button to return to the measuring picture. The
alarm setting range is:71-100
SpO2 Low alarm: After high alarm setting press the right
button to enter into the low alarm of SpO2 setting. Press the up or
down button to set the data. The alarm setting range is: 70-99.
8.4 PR alarm setting:
After SpO2 alarm setting press the right button, and you will enter
into the pulse high alarm setting refer to the picture13: the high alarm
setting range is: 31-255
Press the up or down button to set the data, and press the right button
to set the low PR alarm. The low alarm setting range is: 30-254
8.5 Alarm on/off
After PR alarm setting press the right , and you will enter into the
alarm on/off setting. Press the up or button to set the alarm on
or off.
8.5 ALARM ACTION
Fig.13 Fig.14
Fig.15 Fig.16

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Alarm will be activated on following conditions:
Physiological alarm:
The alarm will work when the SPO2 value or pulse rate beyond the
up-limitation or goes below the down-limitation. The difference is their
priority; the SPO2 has the high priority while the pulse rate has the
medium.
zTechnical alarm (error code):
Table of error code
Alarm priority Status Malfunction phenomenon
E01 Malfunction of SpO2 mode, can
not measure usually
E09 The SpO2 value is lower than
the low limit
High priority
E10 The SpO2 value is higher than
the high limit
E03 Signal strength weak
E11 The value of pulse rate is lower
than the low limit
E12 The value of pulse rate is higher
than the high limit
E13 Power supply is lower. When
battery power is lower than2.4V,
the LED on, and the unit will be
power off automatically
Medium priority
E14 Timing system Low Power
indication ：The power of the
timing system is another internal
button battery. When the symbol
displayed, the time should be
set after every power on,
otherwise the time would be
error.

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E04 Sensor is unplugged
E05 No finger or sensor problem
E06 Searching for pulse
E07 Searching too long
Low priority
E08 Lost pulse alarm
Note: The symbol “Beep off” indicates no selection for voice.
When the E9, E10, E11 or E12 occurs, the value of the LED
displays will flash.
zCheck the error code
Press right key under initial display mode, it will indicate error code if
there have. If want to return initial mode please press menu keypad
again.
Warnings!
When 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.
zCheck the alarm when no warning.
9 Beep on/off
Press the menu key five times under the
interface of initial display mode to enter access
to this function, associated display shown as
below.
Press up or down key to set the speaker on/off.
10Maintain and Repair
10.1 Maintenance
It is very important for user to make daily maintenance of oximeter and
Fig.15