Vapotherm Oxygen Assist Module, Инструкция по эксплуатации

Страница: 6 / 32

Page 6 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Section 1 Indications, Warnings and Cautions
◦
Very low arterial perfusion
◦
Extreme motion artifact
◦
Abnormal venous pulsation or venous constriction
◦
Severe vasoconstriction or hypothermia
◦
Arterial catheters and intra-aortic balloon
◦
Intravascular dyes, such as indocyanine green or methylene blue
◦
Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.
◦
Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc.
◦
Skin color disorders
•
Interfering Substances: Dyes or any substance containing dyes that change usual blood
pigmentation may cause erroneous readings.
•
The Oxygen Assist Module should not be used as the sole basis for medical decisions. It must
be used in conjunction with clinical signs and symptoms
•
The SpO
2
measurement on the Oxygen Assist Module is not a measure of apnea.
•
The Oxygen Assist Module may be used during defibrillation but this may affect the accuracy or
availability of the SpO
2
measurement.
•
The Oxygen Assist Module may be used during electrocautery, but this may affect the accuracy
or availability of the SpO
2
measurement.
•
The SpO
2
measurement on the Oxygen Assist Module should not be used for arrhythmia
analysis.
•
SpO
2
is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
•
Do not adjust, repair, open, disassemble, or modify the Oxygen Assist Module or accessories.
Injury to personnel or equipment damage could occur. Return the Oxygen Assist Module for
servicing if necessary.
Cautions:
•
Do not place the Oxygen Assist Module where the controls can be changed by the patient.
•
Electrical shock and flammability hazard: Before cleaning, always turn off the device and
disconnect from any power source.
•
When patients are undergoing photodynamic therapy they may be sensitive to light sources.
Pulse oximetry may be used only under careful clinical supervision for short time periods to
minimize interference with photodynamic therapy.
•
Do not place the Oxygen Assist Module on electrical equipment that may affect the device,
preventing it from working properly.
•
If SpO
2
values indicate hypoxemia, a laboratory blood sample should be taken to confirm the
patient’s condition.
•
If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In
the interim, assess the patient and, if indicated, verify oxygenation status through other means.
•
Change the application site or replace the SpO
2
sensor and/or patient cable when a “Replace
sensor” and/or “Replace patient cable”, or a persistent poor signal quality message (such
as “Low SIQ”) is displayed. These messages may indicate that patient monitoring time is
exhausted on the patient cable or sensor.