Medipost-Nutristoma MD300K2 User manual

Copyright
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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
- 2 -- 2 -
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.