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3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Section 1 Indications, Warnings and Cautions
Primary Indications
The Oxygen Assist Module is an optional module used only with the Vapotherm Precision Flow
and is indicated for on-demand titration of oxygen into warm humidified breathing gases delivered
to spontaneously breathing patients based on continuous non-invasive monitoring of blood oxygen
saturation.
The Oxygen Assist Module is intended to treat pediatric (including neonatal) and adult patients in
monitored clinical environments.
Warnings and Cautions
•
A Warning indicates that a situation may occur which is potentially harmful to the patient or user.
•
A Caution indicates a condition that may lead to equipment damage, malfunction or inaccurate
operation.
•
A Note indicates a point of emphasis to make operation more efficient or convenient.
Please take the time to familiarize yourself with the warnings, cautions, and notes listed in these
Instructions for Use and in the Precision Flow Instructions for Use.
The user of this product shall have sole responsibility for any malfunction due to operation or maintenance
performed by anyone not trained by Vapotherm staff or official training documentation.
When handling any part of the Precision Flow system, always follow hospital infection control
guidelines and standard precautions. Vapotherm also recommends that users follow the Center
for Disease Control (CDC) publications Guidelines for Maintenance of In-Use Respiratory Therapy
Equipment and Guidelines for Prevention of Nosocomial Pneumonia. For more information, see the
Precision Flow Instructions for Use.
General Warnings
Federal Law (U.S.) restricts the use of this device to, or by the order of a physician. This device should
be used only by clinical staff who are trained on use and operation of the Oxygen Assist Module and
the Precision Flow.
Service on the device should only be performed by qualified, certified service technicians.
If the device is damaged or not working properly, do not use. Contact your authorized clinical trial
study coordinator.
Do not operate if power cord is damaged. Do not use any cord except the one provided. Do not use
extension cords.
WARNING: Do not modify this equipment without authorization of the manufacturer.
Failure to follow this warning may result in device failure or patient harm.
For use only in a clinical setting with standard of care patient monitoring. Operator shall remain close
enough to hear alarms.
For use only on spontaneously breathing patients. The Precision Flow
®
with or without the Oxygen
Assist Module is not life supporting.
Incorporation of SpO
2
into the Precision Flow
®
with the Oxygen Assist Module
does not eliminate the need for separate and independent patient monitoring
indicated by the Precision Flow
®
system labeling.
Patients on high velocity nasal
insufflation receiving supplemental oxygen are acute and appropriate clinical vigilance should be
observed by the care team. Additional patient monitoring including pulse oximetry is necessary if the
Precision Flow
®
is used to give supplementary oxygen.
Do not initiate automatic oxygen delivery with the Oxygen Assist Module until the patient’s SpO
2
is
stable.
