3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Page 5
Section 1 Indications, Warnings and Cautions
For more information, see the Precision Flow Instructions for Use.
Masimo
®
Warnings, Cautions and Notes
General:
•
The Oxygen Assist Module is to be operated by, or under the supervision of, qualified
personnel only. The manual, accessories, directions for use, all precautionary information,
and specifications should be read before use.
Warnings
:
•
As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
•
Do not place the Oxygen Assist Module or accessories in any position that might cause it to
fall on the patient.
•
Do not start or operate the Oxygen Assist Module unless the setup was verified to be correct.
•
Do not use the Oxygen Assist Module during magnetic resonance imaging (MRI) or in an MRI
environment.
•
Do not use the Oxygen Assist Module if it appears or is suspected to be damaged.
•
Explosion hazard: Do not use the Oxygen Assist Module in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
•
To ensure safety, avoid stacking multiple devices or placing anything on the device during
operation.
•
To protect against injury, follow the directions below:
◦
Avoid placing the device on surfaces with visible liquid spills.
◦
Do not soak or immerse the device in liquids.
◦
Do not attempt to sterilize the device.
◦
Use cleaning solutions only as instructed in this Instructions for Use.
◦
Do not attempt to clean the device while attached to a patient.
•
To protect from electric shock, always remove the SpO
2
sensor and completely disconnect the
Oxygen Assist Module from the patient before bathing the patient.
•
If the SpO
2
measurement seems questionable, first check the patient’s vital signs by alternate
means and then check the Oxygen Assist Module for proper functioning.
•
Inaccurate SpO
2
readings may be caused by:
◦
Improper sensor application and placement
◦
Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with
a seemingly normal SpO
2
. When elevated levels of COHb or MetHb are suspected,
laboratory analysis (CO-Oximetry) of a blood sample should be performed.
◦
Elevated levels of bilirubin
◦
Elevated levels of dyshemoglobin
◦
Vasospastic disease, such as Raynaud’s, and peripheral vascular disease
◦
Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc.
◦
Hypocapnic or hypercapnic conditions
◦
Severe anemia
