Introduction; Brief Introduction; Intended Use; Measurement Principle - Apex MD300M Bedienungsanleitung

MD300M

1 Introduction

1.1 Brief Introduction

Thank you for purchasing the MD300M pulse oximeter. The main functions of the device
include SpO , PR and PI (Perfusion Index) measurements, visual and audible alarm, data
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storage, review and transmission, etc. Please read this manual carefully before using the
device.
Notes:
1. The illustrations applied in the manual may differ slightly from the actual device.
2. The specifications are subject to change without prior notice.
3. The device is designed of handheld structure and please be sure not to turn upside down
when using it.

1.2 Intended Use

The MD300M pulse oximeter is intended for continuous monitoring, spot-checking of oxygen
saturation (SpO ) and pulse rate (PR) of single adult and pediatric patients in hospitals and
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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 (HbO
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 finger-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 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.
PULSE OXIMETER
) in red and near-infrared zones. Operation
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INSTRUCTION MANUAL
Warnings!
Before use, carefully read the manual. This device is intended for use by persons trained
in professional health care. Our company will assume no warranty for using this equipment
improperly.
The pulse oximeter is to be operated by qualified personnel only.
Operation of the pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
Sensor malfunction may cause inaccurate data possibly resulting in patient injury or death,
so pay close attention to the sensor and inspect it often.
Do not use the pulse oximeter in an MRI or CT environment.
Although the pulse oximeter has alarms, it is not suggested for long time continuous
monitoring.
Do not use the pulse oximeter in an explosive atmosphere.
The 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.
Check the pulse oximeter sensor application site half an hour to determine the positioning
of the sensor and circulation and skin sensitivity of the patient.
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 60601-1. Any
input/output device should be following the protocol of IEC 60601-1.
Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the
device in liquid. The device is not intended for sterilization.
Follow local ordinances and recycling instructions regarding disposal or recycling of the
device and device components, including batteries.
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.
Portable and mobile RF communications equipment can affect medical electrical equipment.
You should operate the equipment according to the EMC information provided in the
accompanying documents.
This equipment should not be used adjacent to or stacked with other equipment.
This equipment is not intended for use during patient transport outside the healthcare
facility.
When 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 60601-
1. Any input/output device should follow the protocol of IEC 60601-1.
When using the equipment, the voice of the environment is not greater than 45 db.
Rx only: "Caution: Federal law restricts this device to sale by or on the order of a
physician."
Cautions:
The pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO
measurement. Verify that nothing is hindering the pulse measurement before relying on the
SpO measurement.
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MD300M
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