Vapotherm Oxygen Assist Module User manual

Oxygen Assist Module
for use with Vapotherm Precision Flow®
Instructions for Use

Page 2 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Table of Contents Page
Symbols 3
Section 1 Indications, Warnings and Cautions 4
Section 2 Principles of operation 8
Section 3 Components 9
Section 4 Assembly and connections 10
Section 5 Controls and Displays 11
Section 6 Power Up and Basic Setup 12
Section 7 Patient Admission 12
Section 8 Alarm Setup 13
Section 9 SpO2Setup 13
Section 10 %O2Setup 16
Section 11 System Shutdown 17
Section 12 Graphical Trend Display 17
Section 13 Logging of Variables 17
Section 14 Cleaning and Disinfecting 18
Section 15 Data Download 18
Section 16 Software Updates 18
Section 17 Referenced Documentation 18
Section 18 Troubleshooting and Support 19
Section 19 Specifications 20
Section 20 Alarm and Advisory Messages 23
Section 21 Terminology 25
Section 22 Further Reading 25
Appendix 26

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 3
Symbols
Attention: Consult Manual
Warning: Instructions for Use must be read
Alternating Current
Single Patient Use
Protective Earth
Do not cover
Type BF Class 1
This symbol indicates that the waste of electrical and electronic equipment must not
be disposed as an unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
Device On/Off
Alarm Silence/Suspend
Alarm Silenced
Battery Charge
USB Connected
Electronic Medical Record Connection Receptacle
SpO2Patient Cable Connection Receptacle
USB Connection Receptacle
Ethernet Connection Receptacle
Nurse Call Connection Receptacle
Precision Flow Connection Receptacle
Reserved Connection Receptacle

Page 4 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 SpO2into 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 SpO2is
stable.

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 SpO2sensor and completely disconnect the
Oxygen Assist Module from the patient before bathing the patient.
• If the SpO2measurement seems questionable, first check the patient’s vital signs by alternate
means and then check the Oxygen Assist Module for proper functioning.
• Inaccurate SpO2readings 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 SpO2. 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

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 SpO2measurement 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 SpO2measurement.
• The Oxygen Assist Module may be used during electrocautery, but this may affect the accuracy
or availability of the SpO2measurement.
• The SpO2measurement on the Oxygen Assist Module should not be used for arrhythmia
analysis.
• SpO2is 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 SpO2values 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 SpO2sensor 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.

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 7
Section 1 Indications, Warnings and Cautions
• If using the Oxygen Assist Module during full body irradiation, keep the SpO2sensor out of the
radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the
device might read zero for the duration of the active irradiation period.
• Variation in measurements may be profound and may be affected by sampling technique as
well as the patient's physiological conditions. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated and/or supplemented with additional test data.
Blood samples should be analyzed by laboratory instruments prior to clinical decision making
to completely understand the patient’s condition.
• Do not submerge the Oxygen Assist Module or any associated accessories in any cleaning
solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any
other method. This will seriously damage the device.
• Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-
applied circuits and the system are within acceptable limits as specified by the applicable
safety standards. The summation of leakage currents must be checked and in compliance
with IEC 60601-1 and UL60601-1. The system leakage current must be checked when
connecting external equipment to the system. When an event such as a component drop of
approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before
further use. Injury to personnel could occur.
• Disposal of product - Comply with local laws in the disposal of the device and/or its
accessories.
• To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the Oxygen Assist Module.
• Replace the SpO2cable or sensor when a replace sensor or when a low SIQ message is
consistently displayed while monitoring consecutive patients after completing troubleshooting
steps listed in this manual.
Notes:
• A functional tester cannot be used to assess the accuracy of the SpO2measurement on the
Oxygen Assist Module.
• High-intensity extreme lights (such as pulsating strobe lights) directed on the SpO2sensor,
may not allow the Oxygen Assist Module to obtain an accurate reading.
• Do not loop the SpO2patient cabling into a tight coil or wrap around the device, as this can
damage the patient cabling.
• Additional information specific to the Masimo sensors compatible with the Oxygen Assist
Module, including information about parameter/measurement performance during motion and
low perfusion, may be found in the sensor's directions for use (DFU).
• SpO2cables and sensors are provided with X-Cal™ technology to minimize the risk of
inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor
DFU for the specified duration of the patient monitoring time.
This device is covered under one or more patents as set forth at: www.masimo.com/patents.htm
NO IMPLIED LICENSE: Possession or purchase of this device does not convey any express or
implied license to use the device with unauthorized sensors or cables which would, alone or in
combination with this device, fall within the scope of one or more of the patents relating to this
device.

Page 8 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
The Vapotherm Oxygen Assist Module is designed to work with the Precision Flow system to manage
oxygen delivery based on patient clinical need as reflected in their SpO2reading. This automatic
control system uses a proprietary feedback control algorithm to track a patient’s oxygen saturation
and automatically adjust the oxygen concentration delivered through their respiratory support.
The Vapotherm Oxygen Assist Module uses proven pulse oximetry and Precision Flow gas delivery
technologies and a proprietary algorithm that increases or decreases the %O2setting in an effort to
maintain a target SpO2value. The clinician sets the target SpO2and the system uses the algorithm
that combines analysis of real-time measurements and trending to choose the appropriate %O2
delivery. The use of smart averaging and hysteresis algorithms by the Masimo SET™ SpO2monitor
protects the system from artifacts that could cause too rapid cycling of O2delivery. Oxygen Assist
Module is designed for use with the Precision Flow System, which controls the %O2delivery based on
a setting sent from Oxygen Assist Module or being set on the Precision Flow itself manually.
The Oxygen Assist Module communicates with the Precision Flow through the serial interface port
located on the back of the Precision Flow unit.
NOTE: Some clinicians may find the peak wavelengths and radiant power of the light emitting diodes
employed in the SpO2probe useful. Masimo’s sensors use Red and Infrared light emitting diodes.
These diodes emit at 660nm and 905nm respectively and have a radiant power of less than 15mW.
Section 2 Principles of Operation
Vapotherm Precision Flow
Vapotherm Oxygen
Assist Module

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 9
Section 3 Components
The Vapotherm Oxygen Assist Module consists of the following parts:
• The Oxygen Assist Module
• Pole Mount Assembly
• Power Supply
• Masimo SpO2Patient Cable
WARNING: The provided power adapter is the only adapter approved for use with the Oxygen
Assist Module and provides 12VDC to the Oxygen Assist Module. Contact
Vapotherm if you believe your power adapter to not be functional or you need a
replacement. Only use power adapter as provided by Vapotherm.
Masimo sensors are available separately. Approved Masimo sensor models include the following:
• LNCS®Adhesive Sensors
• LNCS®Neo-3 Adhesive Sensors
• RD SET™ Sensors
WARNING: Applied parts that may be used with the Oxygen Assist Module are the Masimo
SpO2probes referenced above. Please consult Masimo accompanying
documents for details.

Page 10 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Section 4 Assembly and Connections
System Assembly
1. Affix the Oxygen Assist Module to the Pole Mount Assembly.
2. Mount the Oxygen Assist Module to the Vapotherm approved roll stand as shown.
3. Remove the silicone plug in the oxygen sensor cover on the back of the Precision Flow.
4. Plug the communication cable into the Oxygen Assist Module and tighten the two thumb screws.
5. Connect the communication cable from the Oxygen Assist Module into the Precision Flow’s
interface port.
6. Plug the Oxygen Assist Module Power Supply into the Oxygen Assist Module and into an
electrical outlet marked “Hospital Grade” or “Hospital Only.”
NOTE: Ensure proper orientation on Power Supply connector when inserting into the Oxygen
Assist Module.
WARNING: Do not position the Oxygen Assist Module so that it is difficult to disconnect the
device.
Sensor Connection
• Connect the SpO2patient cable to the SpO2receptacle on the connector panel of the Oxygen
Assist Module. Please consult Attaching the Sensor to the Patient Cable in the Masimo
DIRECTIONS FOR USE to learn how to connect the sensor.
Oxygen
Assist
Module
mounted
and
plugged
into the
Precision
Flow and
Power
Vapotherm Oxygen Assist Module Connector Panel

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 11
Section 5 Controls and Display
The Oxygen Assist Module is controlled via two fixed keys (On/Off; Alarm Silence), a settings control
knob, and a touch screen. When connected to the Precision Flow and to the patient via an SpO2
sensor, the Oxygen Assist Module delivers manual control (Manual Mode) or automatic control (Auto
Mode) delivery of oxygen.
Using Menus
• To call up a menu, press the desired menu tab. Alternately, parameter boxes will redirect to
the associated menu.
Notes:
Unless otherwise stated, the change to settings takes effect when you press the key.
1 Patient Type Indicator 5 Message Display
2 Trend Display 6 %O2Mode (Auto; Manual)
3 Patient ID, Time and Date Display 7 Parameter Boxes (press to call up menus)
4 Alarm Silence Indicator (crossed when silenced) 8 Menu Keys
Note: The Oxygen Assist Module is calibrated to display functional oxygen saturation. Both SpO2and
%O2displayed values on the trend display are normalized as percentages.

Page 12 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
System Setup
1. Set up the Precision Flow according to Precision Flow Instructions for use. Connect oxygen
and air supply hoses to correct inlets, then connect them to wall outlets. Connect power cord.
2. Plug the Oxygen Assist Module unit into power. The “Splash Screen” will be shown while the
system powers up. The On/Off Key is used to turn on the device when plugged into power.
Select the System Menu. Set TIME and DATE to their correct values.
3. Set the Auto Mode Override to the desired setting. Options are: Exit Auto Mode, 120, 90, 60,
30, 15, or 5 seconds. “Auto Mode Override” establishes how the Oxygen Assist Module will
respond to a manual change of the %O2delivery using the Precision Flow when the Oxygen
Assist Module is in Auto Mode. A manual change in %O2on the Precision Flow with “Exit Auto
Mode” selected will immediately place the Oxygen Assist Module in Manual %O2Mode. A
manual change in %O2on the Precision Flow with “120/90/60/30/15/5” seconds selected will
suppress Auto Mode %O2titration for that period of time before the Oxygen Assist Module
restarts auto %O2titration.
4. Set preferred speaker volume and screen brightness.
System Access
PINs are required to access Software Updates, Case Data, and Institutional Defaults.
Default PINs:
Software Update - 1234
Manage Case Data - 5678
Institutional Defaults - 0987
PINs can be changed on the System screen by using the Access Tab.
Alarm Indications
Section 6 Power Up and Basic Setup
Section 7 Patient Admission
The Patient menu allows the selection of the patient type and patient specific settings, as well as
starting a new case and switching between Auto and Manual %O2Mode.
1. Set the Patient Type (Neonate), %SpO2Target, %SpO2Upper and Lower Range, Backup %O2,
and %O2Alarm Limit.
2. Press Start Case. When a new case is started, the Oxygen Assist Module creates a new Patient
ID consisting of a date and time stamp. This Patient ID is displayed at the top of all screens.

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 13
Section 8 Alarm Setup
The Oxygen Assist Module announces 1 level of alarm:
• Medium Priority Alarm: Flashing amber; burst of 3 beeps.
The Oxygen Assist Module displays silent advisory messages in the message area.
Notes:
Before starting a new case, with the patient sensor disconnected, confirm that the alarm system is
functional by observing that an alarm is generated stating "No Sensor Connected".
Alarm messages cycle in the message area.
For a list of alarm messages and required action, please see the section Alarm and Status
Messages.
For alarm indications of the Precision Flow, please see the Precision Flow Instructions for Use.
Alarm Silence/Suspend
• Press the Alarm Silence fixed key to mute all alarms for 2 minutes.
Note: If alarms are muted, a crossed bell icon appears in the upper right-hand
corner of the screen.
Warnings:
If alarms are silenced for 2 minutes, a subsequent alarm of the same alarm priority will not be
announced during the 2-minute alarm silence period.

Page 14 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Sensor Selection and Placement
When selecting a sensor, consider the following:
• Patient weight
• Patient activity level
• Patient perfusion levels
• Available sensor sites
• Anticipated duration of SpO2monitoring
Masimo sensor models include the following:
• LNCS®Reusable Sensors (1)
• LNCS®Adhesive Sensors (2)
• LNCS®Neo-3 Adhesive Sensors (3)
• RD SET Sensors (4)
Apply the sensor as follows:
1. Clean application site. Remove nail polish, if necessary.
2. Select an appropriate sensor and apply as directed in the sensor documentation.
3. If there is bright ambient light, cover the application site with opaque material. (Direct sunlight,
surgical and fluorescent lights, bilirubin lamps, and infrared heating lamps can interfere with
sensor performance.
For more information on application of the sensor, consult Site Selection in the Masimo DIRECTIONS FOR USE.
Warnings:
• Use only approved Masimo oximetry sensors for SpO2measurements. Other sensors may cause
incorrect SpO2readings.
• Before using the sensor, carefully read the sensor documentation, including all warnings,
cautions and instructions.
• The accuracy of pulse oximetry readings can be adversely affected by ambient conditions,
sensor application errors, and patient movement.
• Do not use the sensor on an extremity with a blood pressure cuff, arterial catheter or
intravascular line.
• Significant levels of dysfunctional hemoglobin (HbCO or MetHb) can cause inaccurate readings.
• Do not use a damaged sensor or damaged patient cables.
• Do not use a sensor with exposed optical components.
• Do not use sensors in MR environments. Conducted current could cause burns.
• Use of the sensor during defibrillation may cause incorrect readings.
• Incorrect application and prolonged use of the sensor can cause tissue damage. Inspect the
application site frequently to ensure that correct sensor positioning is maintained, and to detect
any skin irritation.
• Do not wrap the sensor too tightly.
• Do not apply excessive tension to sensor cables.
• Do not immerse the sensor or patient cables in water, solvents, or cleaning solutions. Sensor,
connectors and patient cables are not waterproof.
Section 9 SpO2Setup

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 15
• Do not sterilize the sensor or patient cables by irradiation, steam, or ethylene oxide. Consult the
cleaning and sterilization instructions in the documentation for reusable pulse oximetry sensors
and patient cables.
Note: The sensors used with this device can be categorized as surface devices contacting
skin for a limited period of time. The sensors have passed the recommended biocompatibility
testing and are therefore in compliance with ISO 10993–1.
SpO2Parameter Box Display
Note: The indicator lights provide information on Signal IQ. Green denotes Signal IQ values of equal to
or greater than 0.3%. Red denotes Signal IQ values of less than 0.3%.
The SpO2display range is from 1-100%. A value of “---“ indicates that no measurement is available. The
pulse rate display range is from 1-240 bpm. A value of “---“ indicates that no measurement is available.
Note: The SpO2, pulse rate, and Signal IQ are updated once per second.
SpO2Target Setup
1. Press the SpO2Target Box on the Home screen or select the Patient menu to set the SpO2target.
2. Press the %SpO2Target parameter box on the touch screen, and set the patient’s target SpO2
using the settings control knob.
3. Set the Target Range by pressing the %SpO2Upper and Lower Range parameter boxes on the
touch screen, and set the percent difference from the %SpO2Target using the settings control knob.
NOTE: Setting the Target Range does not change the SpO2Target. This setting only adjusts
the time in range calculation when reviewing trends.
Section 9 SpO2Setup

Page 16 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Section 10 %O2Setup
Goal and purpose: The automatic %O2control system uses the patient’s measured SpO2values to
control the delivery of %O2based on patient need. When the automatic %O2control mode is enabled,
the system tries to maintain the patient’s SpO2level at or near a preconfigured SpO2target (see also
Further Reading).
1. Select the Patient menu to set the %O2Mode.
2. Press the Backup %O2parameter box on the touch screen, and set the patient’s Backup %O2
using the settings control knob.
Note: See description of Fallback %O2Functionality on the following page for more information.
3. Insert Oxygen Assist Module Time Card and Press Start Case. When the patient is stable, press
the O2Mode AUTO button to put the device into Auto Mode (default is Manual).
Note: To enable Auto %O2Mode, there must be a time card inserted and a patient case started
on the Oxygen Assist Module.
4. The Home screen will now display AUTO mode and the Oxygen Assist Module will begin auto
%O2titration based on the patient’s SpO2level and the set %SpO2Target. %O2delivered by the
Precision Flow can range from 21-100%, unless a %O2Limit is set. Delivered %O2can be seen on
the Precision Flow display, or on the Oxygen Assist Module Home Screen graphical trend display.

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 17
Fallback %O2Functionality
For short instances of invalid or unreliable SpO2readings, an error message is displayed that reflects
the error condition and the Oxygen Assist Module will continue to deliver the calculated %O2until the
SpO2reading becomes valid and reliable.
While the SpO2signal is invalid or unreliable, the %O2delivery is set to the greater of the following:
• The Backup %O2setting.
• The Baseline %O2setting, algorithm calculated as the value needed to keep the patient at
SpO2set point during the period the Oxygen Assist Module was in Auto %O2Mode.
• The median value of the last three Auto %O2values delivered prior to the SpO2failure.
The Oxygen Assist Module automatically exits the Auto mode under the following circumstances:
• Clinical staff changes %O2settings at the Precision Flow. The Oxygen Assist Module behaves
according to Auto Mode Override setting.
• The Oxygen Assist Module detects invalid or unreliable SpO2reading as described above for
more than 2 minutes.
If the Oxygen Assist Module has exited the Auto mode, check the patient, sensor placement,
connections and settings. When clinically indicated, place the Oxygen Assist Module back into Auto
mode in the Patient menu.
System Shutdown
1. On the Patient menu, select End Case.
2. To power down the Oxygen Assist Module, press the On/Off button to turn off the device, then
remove the provided AC power adapter from the AC wall receptacle.
Trend data is displayed on the Home screen. It shows SpO2(blue) and %O2(green) trended values,
with the latest values on the right hand side of the display and oldest to the left. %O2 Alarm Limit is
shown by the dashed red line. The trend display is updated every second. The trend data can also
be viewed on the Trend screen, where the trend display time can be adjusted.
On the Trend screen, the trend data can be viewed and display can be modified using the
navigation buttons.
The following variables are logged at one second intervals and stored indefinitely in non-volatile
memory. The non-volatile memory retains its settings even after a loss of power or the system has
been turned off.
• Time stamp
• SpO2
• %O2
• Auto/Manual Mode
Section 10 %O2Setup
Section 11 System Shutdown
Section 12 Graphical Trend Display
Section 13 Logging of Variables

Page 18 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
The Oxygen Assist Module must always be cleaned and disinfected between patients. Follow the steps
below to ensure a clean and disinfected device.
• Wipe down the main unit with Super Sani-Cloth®.
• Examine for visible soil. If visible soil is present, use a brush (e.g. Spectrum M16 brush) to
remove visible soil.
• Wet the module with another Super Sani-Cloth®. Keep the surface wet for at least six minutes.
Use additional Super Sani-Cloth®if needed.
Caution: Do not use bleach, organic solvents or abrasive cleaners.
For cleaning and disinfecting instructions for the Precision Flow, see the Precision Flow Instructions for Use.
For cleaning and disinfecting instructions for the SpO2sensor and patient cable, see the instructions
provided with the sensor.
Section 14 Cleaning and Disinfecting
Section 17 Referenced Documentation
Precision Flow Instructions for Use can be found at our website www.vapotherm.com
Section 15 Data Download
1. Insert USB Drive into the Oxygen Assist Module.
2. On the System screen, select Case Data and enter PIN.
3. Choose which Case file or files to download and press Download button.
NOTE: Downloading multiple large case files may take several minutes to complete.
4. Once data is saved, press OK and remove USB Drive.
5. As needed, delete Case files to clear Local Storage.
Section 16 Software Updates
1. Insert USB Drive with software file into the Oxygen Assist Module.
2. On the System screen, select Updates and enter PIN.
3. Select Update Software.
NOTE: System will reboot throughout the Software Update Process

3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use Page 19
General
If you need assistance with the Oxygen Assist Module of Vapotherm system, please contact
Vapotherm Technical Support at [email protected].
The Oxygen Assist Module has a user-replaceable battery. Remove the mounting plate on the back
of the Oxygen Assist Module to access battery compartment. Remove old battery and replace with
new battery (Contact Vapotherm Technical Support at [email protected]).
Prior to use, perform a visual inspection of the display, casing, and wires to confirm there is no
visible damage.
Troubleshooting: SpO2
Section 18 Troubleshooting and Support
Condition Probable Cause Action
No signal:
SpO2and PR at 0
Clinical (patient condition). Check patient.
Sensor not connected. Check sensor and cable connections.
Sensor off patient. Check sensor application.
Sensor or cables damaged. Check sensor and cables. Replace, if
necessary.
Excessive patient movement or
electrosurgical interference.
If possible, keep patient still. Check
sensor and sensor application. Move
sensor to a different site or use a sensor
that tolerates more motion.
Inaccurate
SpO2values
Clinical (patient condition). Check patient.
Excessive ambient light. Check sensor. Cover sensor with opaque
material.
Excessive movement.
If possible, keep patient still. Check
sensor and sensor application. Move
sensor to a different site or use a sensor
that tolerates more motion.
Nail polish at application site. Remove nail polish.
Sensor is applied on an extremity that has
a blood pressure cuff, arterial catheter or
intravascular line.
Move sensor to a different site.

Page 20 3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Section 19 Specifications
Physical Characteristics
Dimensions: Height 9”, width 9”, depth 4”
Weight: 4.1 lbs.
Mounting: VESA Oxygen Assist Module Pole Mount Assembly
Connections: Via Oxygen Assist Module communication cable to Precision Flow
System Requirements
Power:
Included 12VDC power supply operates over 100-240VAC, 18W, 47-63Hz
This power adapter provides magnetic isolation of the Oxygen Assist Module to
the mains supply.
Battery: Li-ion, 34-37 Wh, internal
External Battery Charger: N/A
Environment
Operation:
Ambient Temperature: 18-30°C
Ambient Relative Humidity: 20-90% RH non-condensing
Ambient Pressure: Standard atmospheric (not to be used in hyperbaric cond.)
Storage and Shipping: Ambient Temperature: -10- +50°C
Ambient Relative Humidity: 20-90% RH
Contact with Patient: Indirectly via SpO2sensor and Precision Flow O2cannula
Liquid Ingress Protection: IPX2 – Drip-proof
Alarm Sound Pressure Medium Priority Alarm 65dBA maximum at volume setting 10
Operating Altitude 2000 meters
Inputs
Sensors: SpO2connector for Masimo patient interface cable
External Device Communication: Connection to Precision Flow via the Oxygen Assist Module communication
cable
Outputs
RJ45 Connection: WARNING: This connection is not intended for network connectivity. It is
for Vapotherm use only.
NOTE: The Oxygen Assist Module system is comprised of the Oxygen Assist Module and the
provided AC power adapter. The provided AC power adapter is protection Class I device.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.