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.
Incorporation of SpO2 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.
Oxygen Assist Module Packaging contains:
Oxygen Assist Module Unit
Quick Reference Guide
Power Cord
Pole Mount Assembly
SpO2 Patient Cable
ALARM/ALERT MESSAGE
ACTION
%O
2
Above Limit*
Increase %O
2
Alarm Limit, or enter MANUAL mode
Battery Backup In Use
Oxygen Assist Module is in Battery Mode. When external power is lost,
the module will automatically switch to Battery Mode
Battery Low
Plug the Oxygen Assist Module into external power
Check Precision Flow
Clear Precision Flow alarm and ensure it is in Run Mode with both Air
and O
2
sources present
Check SpO
2
*
See the alert message on screen for additional information. Reconnect
sensor with good signal or replace SpO
2
sensor or patient cable
Local Storage is Low
Delete Previous Case Files from Local Storage
Local Storage is Full
Delete Previous Case Files from Local Storage
SpO
2
Target > 95%
Change SpO
2
Target to 95% or Below
SpO
2
Target < 85%
Change SpO
2
Target to 85% or Above
Time Near Expiration
Insert new Time Card before time expires or End Case
SYSTEM SET-UP
• Connect Oxygen Assist Module to Precision Flow and ensure the Precision Flow is in
RUN mode and shows a GREEN LED light
• Connect the SpO2 patient cable to the Oxygen Assist Module. Attach the sensor to the
patient cable and apply the sensor to the patient
• Plug Oxygen Assist Module into external power and power on
• On the System screen, check settings
• On the Patient screen, check settings. Select parameters with the touchscreen and
rotate the blue Setting Control Knob to adjust the value.
• Start Case
• Press the O2 Mode AUTO button to begin automatic mode once the patient is in a
stable SpO2 state.