General Description; Measurement Principle; Precautions For Use - VISIOMED OXYcheck VM-300C18 Manuel D'utilisation

GENERAL DESCRIPTION

Oxygen Saturation measures the percentage of Hemoglobin binding
sites in the bloodstream occupied by oxygen. There are many factors that
may alter the hemoglobin's affinity for oxygen, resulting in a lowering of
oxygen saturation in the blood. Monitoring oxygen saturation is critical
to those who may have factors that may cause desaturation, which may
require health care providers to take action to improve this deficiency. A
finger pulse Oximeter can help monitor oxygen saturation.
The Fingertip Pulse Oximeter features small size, low power consumption,
convenient operation, and portability. It is only necessary for a patient
to insert one finger into the fingertip photoelectric sensor for diagnosis,
resulting in a oxygen saturation displayed on screen. It has been proven in
clinical experiments that it also features high precision and repeatability.

MEASUREMENT PRINCIPLE

Principle of the Oximeter is as follows: A mathematical formula is esta-
blished making use of Lambert Beer Law according to Spectrum Absorp-
tion Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin
(HbO2) in glow and near-infrared zones. Operation principle of the instru-
ment : Photoelectric Oxyhemoglobin Inspection Technology is adopted
in accordance with Capacity Pulse Scanning and Recording Technology,
so that two beams of different wavelength of lights (660 nm glow and
940 nm near infrared light) can be focused onto a human nail tip through
a clamping finger-type sensor. A measured signal obtained by a photosen-
sitive element, will be shown on the Oximeter's display.
Diagram of Operation Principle (Figure 2) :
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube

PRECAUTIONS FOR USE

1. Before use, carefully read the manual.
2. Operation of the fingertip pulse oximeter may be affected by the use of
an electrosurgical unit (ESU).
3. The fingertip pulse oximeter must be able to measure the pulse properly
to obtain an accurate SpO measurement. Verify that nothing is hinde-
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Visiomed - VM-300C18 - USER MANUAL - 062014
ring the pulse measurement before relying on the SpO
4. Do not use the fingertip pulse oximeter in an MRI or CT environment.
5. Do not use the fingertip pulse oximeter in situations where alarms are
required. The device has no alarms. It is not for continuous monitoring.
6. Do not use the fingertip pulse oximeter in an explosive atmosphere.
7. The fingertip pulse oximeter is intended only as an adjunct in patient
assessment. It must be used in conjunction with other methods of asses-
sing clinical signs and symptoms.
8. In order to ensure correct sensor alignment and skin integrity, the maxi-
mum application time at a single site for our device should be less than
half an hour.
9. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or
immersing the device in liquid. The device is not intended for sterilization.
10. Follow local ordinances and recycling instructions regarding disposal
or recycling of the device and device components, including batteries.
11. 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.
12. Portable and mobile RF communications equipment can affect medi-
cal electrical equipment.
13. This equipment is not intended for use during patient transport out-
side the healthcare facility.
14. This equipment should not be used adjacent to or stacked with other
equipment.
15. Do not disassemble, repair or modify the equipment without authority.
16. These materials that contact with the patient's skin contain medical
silicone and ABS plastic enclosure are all pass the ISO10993-5 Tests for
invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-
type hypersensitivity.
Inaccurate measurements may be caused by
1. Significant levels of dysfunctional hemoglobin (such as carbonyl -
Visiomed - VM-300C18 - USER MANUAL - 062014
measurement.
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