Medipost-Nutristoma MD300K2 User manual

Copyright
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condential 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 We may also seek to maintain this work as an unpublished copyright.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 software
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All information contained in this publication is believed to be correct. We 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. The information this publication refers 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.
Model: MD300K2
Version: Ver 1.0K2
Revised Date: March 10, 2017

Content
1 INTRODUCTION................................................................................................................1
2 GENERAL DESCRIPTION ...............................................................................................5
3 TIME AND DATE SETTINGS.............................................................................................8
4 TAKE A MEASUREMENT ................................................................................................9
5 SETTING..........................................................................................................................12
6 DATA MANAGEMENT.....................................................................................................15
7 ALARM.............................................................................................................................18
8 MAINTENANCE AND REPAIR........................................................................................20
APPENDIX A SPECIFICATIONS........................................................................................24
APPENDIX B CLINICAL STUDY SUMMARY ....................................................................27
APPENDIX C DECLARATION ...........................................................................................29

INSTRUCTION MANUAL MD300K2
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INSTRUCTION MANUAL
1 INTRODUCTION
1.1 Brief Introduction
Thank you for purchasing the MD300K2 pulse oximeter. The main functions of the device
include SpO2, PR and PI (Perfusion Index) measurements, visual and audible indication,
probe off and nger out indicarion, data storage, transmitting and review etc. Please read this
manual carefully before using the device.
Notes:
The illustrations applied in the manual may differ slightly from the actual device.
The device is designed of handheld structure, please be sure not to turn upside down when
using it.
1.2 Intended Use
The MD300K2 Pulse Oximeter is intended for continuous monitoring, spot-checking of oxygen
saturation (SpO2), pulse rate (PR) and PI (Perfusion Index) of single adult, adolescent, child
and infant patients in hospitals and clinics.
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 red 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 red and 905nm near infrared light) can be focused
onto a human nail tip through a clamping nger-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 users
operation.
Warning - Information concerning something that could possibly hurt the patient or operator.
Caution - Reminds the user to pay close attention to device operation, failure of which may
cause abnormal function of the instrument.
Note - Informs the user of other important information by suggestion, requirement and
supplement.
Warnings!
1. Before use, carefully read the manual. This device is intended for use by persons trained in
Fig.1-1

PULSE OXIMETER
MD300K2
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professional health care. Our company will assume no warranty for using this equipment
improperly.
2. Operation of the handheld pulse oximeter may be affected by the use of an electrosurgical
unit (ESU).
3. Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death,
so pay close attention to the sensor and inspect it often.
4. Do not use the handheld pulse oximeter in an MRI or CT environment.
5. Although the pulse oximeter has alarms, it is not suggested for long time continuous
monitoring.
6. Do not use the handheld pulse oximeter in an explosive atmosphere.
7. The handheld 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.
8. Check the pulse oximeter sensor application site every half an hour to determine the
positioning of the sensor and circulation and skin sensitivity of the patient.
9. When begin to gauge associated body features please follow the doctor’s counseling.
10. When link this equipment to other peripherals, make sure you are sophisticated 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 601-1-1.
11. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the
device in liquid. The device is not intended for sterilization.
12. Follow local ordinances and recycling instructions regarding disposal or recycling of the
device and device components, including batteries.
13. This equipment complies with IEC 60601-1-2:2007 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.
14. You should operate the equipment according to the EMC information provided in the
accompanying documents.
15. Portable and mobile RF communications equipment can affect medical electrical
equipment.
16. This equipment should not be used adjacent to or stacked with other equipment.
17. This equipment is not intended for use during patient transport outside the healthcare facility.
18. When connecting this device to other peripherals, make sure that you are qualied to
operate this device. Any peripheral must be certied according to the protocol of IEC 60601-1.
Any input/output device should follow the protocol of IEC 60601-1.
Cautions:
1. The 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.
2. Worn-out data cables may also cause inaccurate data, so if the data is used as a reference
to treat a patient, pay special attention to data cable and check it more frequently.
3. Do not tangle the SpO2 cable with the wires of ES (Electrosurgery) equipment.
4. Single use accessories should never be reused.

INSTRUCTION MANUAL MD300K2
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5. Only use SpO2 sensors specied by the manufacturer. Other SpO2sensors may cause
improper performance.
6. Unplug the sensor from the monitor before cleaning or disinfecting to prevent sensor or
monitor from being damaged, and to prevent user under safety situation.
7. Alarm must be set up according to different situation of individual patient. Make sure that
audio sound can be activated when alarm occurs.
Notes:
1. Optical cross talk can occur when two or more sensors are located in adjoining areas.
It can be eliminated by covering each site with opaque material. Optical cross talk may
adversely affect the accuracy of the SpO2 readings.
2. Obstructions 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.
3. For routine equipment maintenance, please refer to the service procedures at the
associated section as indicated in the manual.
5. All functions of the device that the intended operator can safely use.
6. The material of the device has no nature latex.
Inaccurate measurements may be caused by:
1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or
methemoglobin);
2. Intravascular dyes such as indocyanine green or methylene blue;
3. High ambient light. Shield the sensor area if necessary;
4. Excessive patient movement;
5. High-frequency electrosurgical interference and debrillators;
6. Venous pulsations;
7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or
intravascular line;
8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia;
9. The patient is in cardiac arrest or is in shock;
10. Fingernail polish or false ngernails;
11. Weak pulse quality (low perfusion);
12. Low hemoglobin;
1.5 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.

PULSE OXIMETER
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1.6 Explanation of Symbols
Symbol Explanation Symbol Explanation
Type BF applied part IPX1 Protected against dripping water
Caution Prevent from rain
Date of Manufacture Manufacturer’s information
SN Serial number User ID
Audio alarm inhibition Battery power indication
Storage temperature and
relative humidity Follow instructions for use
bpm Pulse rate SpO2Hemoglobin Oxygen Saturation
USB cable is connected Battery cover unlock / lock
European union approval Authorized representative in the
European community
Do not discard the device
and other components Class II equipment
Waste electrical and
electronic equipment Beep silence
Alarm inhibit ?Indicate the signal is not stable
1.7 Product Features
Compact, light in weight and simple to use.
TFT displaying screen with adjustable backlight.
Up to 127 user ID and 72-hour records storage.
Visual and three-level audible alarms, low battery alarm.
Data transfer to PC by USB cable.
Powered by three AA alkaline batteries or power adapter (optional).
1.8 Contraindication
None

INSTRUCTION MANUAL MD300K2
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2 GENERAL DESCRIPTION
The handheld pulse oximeter adopts 2.4 inch TFT displaying screen. It can display the SpO2,
PR value, PI, pulse bar, SpO2waveform and other kinds of parameters, such as the time, ID
number, battery status and so on.
2.1 Appearance
Fig.2.1
Description of Fig.2-1:
1. Connector for probe: Used to connect with SpO2 probe with the pulse oximeter.
2. Alarm indicator: When SpO2 or/and PR alarm occurs, It ashes in red.
3. Displaying screen.
4. Navigation buttons (UP, DOWN, LEFT, RIGHT): The function of the left button is conrming
the items that you choose and long press in measurement screen will lead to password
changing screen; the function of the right button is back to the previous or menu interface. In
the measuring interface, press the right button to shift between digital mode and wave mode.
5. Menu button: Short press to enter the main menu; long press it to silence the audio alarm,
the device will be appear the audio alarm indicator icon covered with “X” and countdown, long
press it again, the device will recover the audio alarm.
6. Power button: Press and hold the button for 3 seconds to power the device on, and for
about 4 seconds to power it off.
7. Connector for adapter.

PULSE OXIMETER
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8. USB interface: Used to connect the USB cable for data transmission.
9. Side UP/DOWN button: Press it for extended time to increase/decrease the brightness of
the backlight.
NOTE: In the measuring interface, press the menu button for extended time, the alarm pause
will be turned on; press it again, the alarm pause will be turned off.
2.2 Power Supply
The device can be powered by 3 AA alkaline batteries.
Rear panel introduction:
1: Battery compartment
2: Fixing hole
3: Speaker for alarm
Fig.2.2 Rear Panel
Batteries Installation:
1) Open the battery cover: Slide the xing screw slightly in the rear panel to the position
which is marked with “ ” and then open the cover.
2) Batteries installation: Install 3 AA alkaline batteries or rechargeable batteries lightly as
indicated by the polarity signs as shown in Fig.2-2.
3) Close the battery cover: Close the battery cover and slide the screw to the position. It
means that the battery cover is locked.
Battery life and replacement
When the battery voltage is lower, the battery indicator will become empty and its frame
shows in red, which means few of battery capacity remains. You should replace the batteries
with new ones in time.
Warnings!
If battery fluid should get into your eyes, immediately rinse with plenty of clean water.
Consult a doctor immediately.

INSTRUCTION MANUAL MD300K2
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Be sure to insert the batteries in the correct polarities, as indicated by polarity markings
inside the battery compartment.
Cautions!
Do not use batteries not specied for this unit.
Do not dispose of batteries in re.
Remove the batteries from this unit when you are not going to use it for a long period.
Do not use batteries of different types together.
Do not use new and used batteries together.
Do not use the broken battery.
Dispose of batteries in accordance with the local ordinances and regulations.
AC Power Supply (optional)
When there are no batteries in the battery compartment, the device can be supplied by AC
power through connecting the device to AC adapter.
Note: Use the AC power supply, make sure put the device in the safety and proper place and
convenient to power off.
Warnings!
Be sure to use the adapter that specied for this device.
Plug and unplug the adapter cautiously to avoid injuries caused to your body.
Please remove the adapter from this device when you are not going to use it for a long
period.
If the device suddenly power off, please take out your nger at once, and then connect
power or install the batteries.
The device can measure normally during the process of charging, but we won’t recommend
doing so.

PULSE OXIMETER
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3 TIME AND DATE 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 the Fig.3.1.
Measuring
%
100
090
100
060
98 70
bpm
Menu
Data Management
OK Back12:00
Alarm Setting
System Setting
Date and Time
SpO2PR
SpO2 %
Measuring 120s
SpO
2
%
100
090
100
060
98
PR
70
bpm
Date and Time
Date
Time
04
OK
2012
Cancel12:00
23
06 00
：
SpO2 %
Fig.3.1 Fig.3.2
2) Press the Navigation button to select “Date and Time” item, and then press the OK button
to enter the time setup screen, refer to Fig.3.2.
Press the Navigation button adjust the value, and then press the OK button to conrm the
value.
The date is displayed as the order of Year-Month-Day and Time of Hour-Minute (time show:
24-hour).

INSTRUCTION MANUAL MD300K2
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4 TAKE A MEASUREMENT
4.1 Install the Probe
1. Before use, check the pulse oximeter for mechanical damage.
Fig.4.1
2. Insert the SpO2 probe into the probe socket (refer to Fig.4.1). If the SpO2probe is
disconnected from the unit, a prompt “Probe Off” will be shown in the status bar in the top left
of the display screen.
Note:
The probes that specied for this device conform to the ISO80601-2-61 standard.
The connector is also applied to uploading data to MedView software for reviewing. For
detailed information, refer to the instruction manual of MedView software.
After nishing the time setting, plug your nger into the sensor as shown in the following
illustration.
Fig.4.2 Placement of the sensor
Select the suitable sensor in terms of type and dimension.

PULSE OXIMETER
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4.2 Measurement Screens
There are two display modes as shown in the following pictures.
bpm
PR
12:00
SpO2%
100
090 98
Shift
Measuring
ID:001
100
060 70
1
2
3
4
5
6
7
8
ID:001 12:00
SpO2%
100
090
100
060
98 70
PR bpm
Shift
Measuring
PI % 5.0
1
2
36
5
7
8
9
Fig.4.3 Fig.4.4
Description of measurement screens:
1. Measuring: The pulse oximeter is in the status of measuring.
It shows “Finger off” when there is no nger inserted or no signal is detected.
It shows “Probe off” when the sensor/probe is not connected to the pulse oximeter.
2. 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 SpO2 is beyond the alarm limits.
It shows two dashes throughout probe off and nger out conditions.
3. 100: SpO2high alarm limit; 90: SpO2 low alarm limit.
4. :Pulse bar
5. 100: PR high alarm limit; 060: PR low alarm limit.
6. PR: PR area of display
It shows the pulse rate in beats per minute during normal measurement.
The color of the PR value will become red when the PR is beyond the alarm limits.
It shows three dashes throughout probe off and nger out conditions.
7. ID: 001, the ID number of the current patient is 001.
8. 12:00: The current time.
9. PI%: Perfusion Index indicator display area.

INSTRUCTION MANUAL MD300K2
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Warnings!
Use only SpO2 probes provided by manufacturer. Other SpO2probes may cause improper
performance.
Do not use an SpO2 probe with exposed optical components.
Excessive patient movement may cause inaccurate measurements.
Tissue damage can be caused by incorrect operation or misusing probe; for example,
by wrapping the probe too tight. Inspect the probe site to ensure the skin’s integrity and
the adhesion position of the probe is correct. More frequent inspection should be taken if
necessary.
Loss of pulse signal can occur in any of the following situations:
a) The probe is too tight;
b) There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp,
or sunlight; Pulse sensor should obviate the light source, e.g. radial lamp or infrared lamp.
c) A blood pressure cuff is inated on the same extremity as the one to which an SpO2 sensor
is attached.
After measurement, please take off your nger and press and hold the power button to turn
off the device.

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5 SETTING
5.1 System Setting
Pick and enter the [System Setting] interface from the main menu. And then press the
Navigation buttons to select different item to set.
Measuring 120s
SpO2 %
100
090
100
060
98 70
PR bpm
OK
System Setting
Alarm Volume
Back12:00
Alarm Pause
Beep Tone
Backlight Setting
Language
Screen Sleep Mode
5
120s
5
5
Measuring 120s
100
090
100
060
98 70
PR bpm
OK
System Setting
01
Back12:00
Charging Management
ID setup
Factory Default
SpO2 %
Fig.5.1 Fig.5.2
Alarm Volume: you can adjust the value of alarm volume, there are 7 levels, and the default
level is 3.
Alarm Pause: there are two modes, 60s and 120s, and the default mode is 120s. The device
audibly alarm upon new alarm conditions.
Beep Tone: the level is from 0 to 7, and the default level is 3.
Backlight Setting: the level of brightness is from 1 to 7, and the default level is 3.
Language: English, French, German, Spanish, Italian, Japanese, Russian and Chinese.
Screen Sleep Mode: 1minute, 10 minutes, 30 minutes, screen always on, and the default is
1 minutes
Charging management: Charging activated, Charging stop.
ID setup: ① press OK button, ② press Navigation button to change the number, ③press OK
button to conrm.
Factory Default: recover to factory reset.
Note:
1. Every time enter into the Alarm Volume and Alarm Pause, you should input the password,
refer to Alarm Setting.
2. The ID range is 1~127.

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5.2 Alarm Setting
Pick the [Alarm Setting] interface from the main menu.
Before setting, please enter password (1234) to set the parameter. Or you can direct access
to check the parameter but not to change.
OK
Enter the password
BackOK 09:31
SpO PR bpm2%
100
090
100
088
Finger off
0 0 0 0
Fig.5.3
How do you input passwords?
1. Press the Navigation button to change the numbers.
2. Press the OK button to conrm the number.
3. Press the Navigation button switch to the next numbers.
4. Press the OK button to conrm your selection.
5. Repeat the step one.
How to change the passwords?
In the measuring interface, hole and press the menu button for 5s to change the passwords.
The rst time, enter the old passwords.
The second time, enter the new passwords.
Then you can change the passwords.
Notes:
1. The read-only password is 0000. Under this password, you can only check the parameter
but not change.
2. The make-changes password is 1234, enter this password, you can set the parameters.
3. You can change the password. If you forget the password, Please choose “Factory Default”
in System Setting, the password will Recover to factory password (1234) .
4. Every time enter into the Alarm Setting in the main menu, Alarm Volume and Alarm Pause
in the System Setting, you should input the password.

PULSE OXIMETER
MD300K2
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Enter the [Alarm Setting] interface.
Measuring 120s
SpO2
2
%
100
090
100
060
98
PR
70
bpm
Alarm Setting
Alarm
High Limit
Low Limit
ON ON
OK
100
90 60
100
PRSpO
Cancel12:00
SpO2%
Fig.5.4
You can select the Alarm on or off.
High limit SpO2 range is 71~100, Low Limit SpO2 range is 70~99
High Limit PR range is 31~250, Low Limit PR range is 30~249

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6 DATA MANAGEMENT
Pick and enter the [Data Management] interface from the main menu.
Measuring 120s
SpO2%
100
090
100
060
98
PR
70
bpm
Data Management
Data Review
OK Back12:00
SpO2Trend
PR Trend
Delete all data
Fig.6.1
6.1 Data Review
Pick and enter the “Data review” interface as shown in Fig.6.2. By pressing the UP / DOWN
button, the user can turn to the earlier/later item page.
The pulse oximeter can record the alarming parameter marked with red color. Press the
MENU button, it will return to the main menu interface.
Measuring 120s
SpO2PR
Page 01/80
Time
Back
98 70 1
98 70 1
98 70 1
98 70 1
90 60 1
90 60 1
90 60 1
90 60 1
90 60 1
90 60 1
23/04 06:00:20
23/04 06:00:16
23/04 06:00:12
23/04 06:00:08
23/04 06:00:04
23/04 06:00:00
23/04 05:59:56
23/04 05:59:52
23/04 05:59:48
23/04 05:59:44
ID
Fig.6.2

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6.2 SpO2Trend
Pick and enter the “SpO2 Trend” interface as shown in Fig.6.3. Press the Left / Right button;
you can turn to the earlier or later item page. Press the Up button, the pulse oximeter returns
to the previous interface. Press the MENU button, the pulse oximeter returns to the main
menu interface.
Fig.6.3
On the above of the trend, the date and time of the rst item are displayed, with month/day;
hour: minute: second.
6.3 PR Trend
Pick and enter the “PR Trend” interface as shown in Fig.6.4. Press the Left / Right button; you
can turn to the earlier or later item page. Press the Up button, the pulse oximeter returns to
the previous interface. Press the MENU button, the pulse oximeter returns to the main menu
interface.
Fig.6.4

INSTRUCTION MANUAL MD300K2
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6.4 Delete All Data
Pick and enter the “Delete all data” interface as shown in Fig.6.5. You can select “Yes” or “No”
by pressing the up or down button, and by pressing the OK button to conrm your selection.
Note:
1. Please take caution to the deletion of data; you will never get the data back once deleted.
2. Data is unable to be deleted during measurement.
Measuring 120s
SpO2
%
100
090
100
060
98
PR
70
bpm
Delete all data
YES NO
OK 12:00 Back
SpO2%
Fig.6.5

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7 ALARM
ALARM PRIORITY:
There are two-level priorities for selection.
High priority: the highest level alarm, indicates the patient is in the very dangerous situation.
Low priority: indicate the technical alarm caused by the device itself.
Alarms of the oximeter include technical and physiological alarms. All the two priorities
divided by built-in module and cannot be changed by user.
Assignment of priority:
High Low
Paramter SpO2 / PR /
Value Red /
Alarm lamp Flashing /
Lamp Frequency 1.5Hz /
Audiblesound Di- Di – Di ----- Di - Di Di
Alarm cycle 3 s 20 s
Alarm info SpO2 too high/low, PR too
high/low, Battery power low Probe off/Finger off
Notes:
1. The alarm will appear if the measurement value out of range.
2. The alarm sound will go on until alarm disappears or is turned off.
3. After silencing the alarm, the corresponding indicator will indicate this.
4. The power low alarm: the corresponding indication lamp will be ashing with a red frame.
Warnings!
When the alarm occurs, check patients’ conditions immediately.
Check which parameter is alarming or which alarm is going on.
Check patient’s condition.
Search for the source of alarm.
Make the alarm mute if necessary.
Check the alarm when no warning.
Alarm delay
The alarm condition delay and alarm signal generation delay: less than 1s.