Vapotherm Oxygen Assist Module Instructions for Use Rev C

Table of Contents

Page

Symbols

3

Section 1

Indications, Warnings and Cautions

4

Section 2

Principles of operation

6

Section 3

Components

7

Section 4

Assembly and connections

8

Section 5

Controls and Displays

9

Section 6

Power Up and Basic Setup

10

Section 7

Patient Admission

10

Section 8

Alarm Setup

11

Section 9

SpO2 Setup

12

Section 10

%O2 Setup

15

Section 11

System Shutdown

16

Section 12

Graphical Trend Display

16

Section 13

Logging of Variables

16

Section 14

Cleaning and Disinfecting

17

Section 15

Data Download

17

Section 16

Software Updates

17

Section 17

Referenced Documentation

17

Section 18

Troubleshooting and Support

18

Section 19

Specifications

19

Section 20

Alarm and Advisory Messages

22

Section 21

Terminology

24

Section 22

Further Reading

24

Appendix

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25

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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 SpO2 Patient Cable Connection Receptacle USB Connection Receptacle Ethernet Connection Receptacle Nurse Call Connection Receptacle Precision Flow Connection Receptacle Reserved Connection Receptacle

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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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 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. Do not initiate automatic oxygen delivery with the Oxygen Assist Module until the patient’s SpO2 is stable. Page 4

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

Section 1 Indications, Warnings and Cautions For more information, see the Precision Flow Instructions for Use.

NellcorTM Warnings, Cautions and Notes General:

•

Indicated for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospitaltype facilities.

Warnings:

• •

• • • • • • • • • • •

Use only Medtronic (NellcorTM) OxiMaxTM sensors and accessories. Connecting any other cable or sensor influences the accuracy of sensor data, which may lead to adverse results. Pulse oximetry readings and pulse signals can be affected by certain ambient conditions, sensor application errors and certain patient conditions (examples: excessive patient movement, medical procedures, or external agents such as dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents such as nail polish, dye, or pigmented cream). Carefully read the sensor Instructions for Use, including all warnings, cautions, and instructions. Review safety labeling based on the intended use of the equipment. Do not use a damaged sensor or interface cable. Do not use a sensor with exposed optical components. Incorrect application or inappropriate duration of use of a sensor can cause tissue damage. Inspect the sensor site as directed in the Instructions for Use. Long cables (such as the sensor or extension cable) may cause patient strangulation if routed incorrectly. Do not simultaneously be in contact with device connectors and patient. Do not immerse or wet the sensor. Do not use near MRI device. Do not use oximeter in close proximity to ESU and Defibrillator. Do not use NIBP or other constricting instruments on same appendage as sensor. Use hospital grade line cords in AC-powered systems. Failure to cover the sensor site with opaque material when operating under high ambient light conditions may result in inaccurate measurements. Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, sensor application errors, and certain patient conditions.

Cautions:

• •

Use only differentially wired extension cables. Periodically inspect extension cables and sensors for damage and discontinue the use of these if damage is found. Implement a periodic testing strategy. Hand-held, battery-operated Pulse Simulation testers (SRC-MAX with Respiration Rate Enabled) are available from Medtronic (NellcorTM). Contact Medtronic's Technical Services Department at 1.800.635.5267, or your local Medtronic representative.

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 2 Principles of Operation 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 SpO2 reading. 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.

Vapotherm Oxygen Assist Module

Vapotherm Precision Flow

The Vapotherm Oxygen Assist Module uses proven pulse oximetry and Precision Flow gas delivery technologies and a proprietary algorithm that increases or decreases the %O2 setting in an effort to maintain a target SpO2 value. The clinician sets the target SpO2 and the system uses the algorithm that combines analysis of real-time measurements and trending to choose the appropriate %O2 delivery. Oxygen Assist Module is designed for use with the Precision Flow System, which controls the %O2 delivery 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.

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3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

Section 3 Components The Vapotherm Oxygen Assist Module consists of the following parts:

• • • •

The Oxygen Assist Module Pole Mount Assembly Power Supply Nellcor SpO2 Patient 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. Nellcor sensors are available separately. Approved Nellcor sensor models include the following:

Item Nellcor

SKU

Patient Size

Max Length

Adult SpO2 Sensor, Reusable (Nonsterile)

DS100A

>40 kg

3.0 ft (0.9 m)

NellcorTM Adult Flexible SpO2 Sensor, Reusable (Nonsterile)

FLEXMAX

>20 kg

3.0 ft (0.9 m)

NellcorTM Pediatric Flexible SpO2 Sensor, Reusable (Nonsterile) Small

FLEXMAX-P

>20 kg

3.0 ft (0.9 m)

NellcorTM Adult XL SpO2 Sensor (Sterile, single-use only)

MAXAL

>30 kg

3.0 ft (0.9 m)

NellcorTM Forehead SpO2 Sensor (Sterile, single-use only)

MAXFAST

≥10 kg

2.5 ft (0.75 m)

NellcorTM Neonatal-Adult SpO2 Sensor (Sterile, single-use only)

MAXN

<3 or >40 kg

NellcorTM Infant SpO2 Sensor (Sterile, single-use only)

MAXI

3 to 20 kp

NellcorTM Pediatric SpO2 Sensor (Sterile, single-use only)

MAXP

10 to 50 kg

NellcorTM Adult SpO2 Sensor (Sterile, single-use only)

MAXA

>30 kg

NellcorTM Adult-Neonatal SpO2 Sensor with wraps (Reusable with adhesive)

OXI-A/N

<3 or >40 kg

NellcorTM Pediatric-Infant SpO2 Sensor with wraps (Reusable with adhesive)

OXI-P/I

3 to 40 kg

NellcorTM Pediatric SpO2 Sensor, Two Piece (Sterile, single-use only)

P

10 to 50 kg

NellcorTM Neonatal-Adult SpO2 Sensor, Two Piece (Sterile, single-use only)

N

<3 or >40 kg

NellcorTM Adult SpO2 Sensor, Two Piece (Sterile, single-use only)

A

>30 kg

NellcorTM SpO2 Sensor, Multi-site Reusable (Nonsterile)

D-YS

>1 kg

NellcorTM SpO2 Ear Clip, Reusable (Nonsterile)

D-YSE

>30 kg

NellcorTM Pediatric SpO2 Sensor Clip, Reusable (Nonsterile)

D-YSPD

3 to 40 kg

TM

1.5 ft (0.5 m)

3.0 ft (0.9 m)

OC-3 cable, 3.0 ft (0.9 m)

4.0 ft (1.2 m)

WARNING: Applied parts that may be used with the Oxygen Assist Module are the Nellcor SpO2 probes referenced above. Please consult Nellcor accompanying documents for details.

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 4 Assembly and Connections System Assembly Affix the Oxygen Assist Module to the Pole Mount Assembly. Mount the Oxygen Assist Module to the Vapotherm approved roll stand as shown. Remove the silicone plug in the oxygen sensor cover on the back of the Precision Flow. Plug the communication cable into the Oxygen Assist Module and tighten the two thumb screws. Connect the communication cable from the Oxygen Assist Module into the Precision Flow’s interface port. Plug the Oxygen Assist Module Power Supply into the Oxygen Assist Module and into an electrical outlet marked “Hospital Grade” or “Hospital Only.”

1. 2. 3. 4. 5. 6.

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 SpO2 patient cable to the SpO2 receptacle on the connector panel of the Oxygen Assist Module. Please consult the Nellcor sensor Instructions 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

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3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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 2 3 4

Patient Type Indicator Trend Display Patient ID, Time and Date Display Alarm Silence Indicator (crossed when silenced)

5 6 7 8

Message Display %O2 Mode (Auto; Manual) Parameter Boxes (press to call up menus) Menu Keys

Note: The Oxygen Assist Module is calibrated to display functional oxygen saturation. Both SpO2 and %O2 displayed values on the trend display are normalized as percentages. 3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 6 Power Up and Basic Setup 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 %O2 delivery using the Precision Flow when the Oxygen Assist Module is in Auto Mode. A manual change in %O2 on the Precision Flow with “Exit Auto Mode” selected will immediately place the Oxygen Assist Module in Manual %O2 Mode. A manual change in %O2 on the Precision Flow with “120/90/60/30/15/5” seconds selected will suppress Auto Mode %O2 titration for that period of time before the Oxygen Assist Module restarts auto %O2 titration.

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.

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 %O2 Mode. 1.

Set the Patient Type (Neonate), %SpO2 Target, %SpO2 Upper and Lower Range, Backup %O2, and %O2 Alarm 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.

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3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

Section 8 Alarm Setup Alarm Indications 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.

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 9 SpO2 Setup Sensor Selection and Placement Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented in the Instructions for Use accompanying the sensor. Clean and remove any substances such as nail polish from the application site. Periodically check to ensure that the recommended sensor remains properly positioned on the patient. Consult the sensor Instructions for Use for proper sensor application. Apply the sensor as follows: 1. Remove plastic backing from the sensor and locate transparent windows on the adhesive side. Windows cover optical components. 2. Orient the sensor so the dashed line is on the lateral edge of the site. Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular infusion line. 3. Wrap the sensor firmly, but not too tightly around the foot or finger. Windows must oppose each other. For more information on application of the sensor, consult the Nellcor sensor Directions for Use.

Warnings: Do not use the sensor during MRI scanning. Conducted current may cause burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements.

•

Cautions: In the event of damage to the sterile packaging, do NOT re-sterilize. Follow local governing ordinances and recycling instructions regarding disposal or recycling of sensors. Failure to apply the sensor properly may cause incorrect measurements.

• • • • • • • • • •

While the sensor is designed to reduce the effects of ambient light, excessive light may cause inaccurate measurements. In such cases, cover the sensor with opaque material. Circulation distal to the sensor site should be checked routinely. The site must be inspected every 8 hours to ensure adhesion, application pressure, skin integrity, and correct optical alignment. If skin integrity changes, move the sensor to another site. If the sensor is misapplied with excessive pressure, a pressure injury can occur. Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream may lead to inaccurate measurements. Excessive motion may compromise performance. In such cases, try to keep the patient still, or change the sensor site to one with less motion. Do not immerse in water or cleaning solutions. Do not resterilize. Immersion or resterilization could damage the sensor. If the sensor is wrapped too tightly or supplemental tape is applied, venous pulsations may lead to inaccurate saturation measurements. Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy. For additional warnings, cautions or contraindications when using this sensor with Nellcorcompatible instruments, refer to the instrument operator’s manual or contact the manufacturer of the instrument. Note: High oxygen levels may predispose a premature infant to develop retinopathy. Therefore, the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical standards and considering the accuracy range of the oximeter being used.

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3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

Section 9 SpO2 Setup It is important that an appropriate / recommended sensor is selected, apply it as directed, and observe all warnings and cautions presented in the Instructions for Use accompanying the sensor. Clean and remove any substances such as nail polish from the application site. Periodically check to ensure that the recommended sensor remains properly positioned on the patient. High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a recommended sensor. To prevent interference from ambient light, ensure the recommended sensor is properly applied and cover the sensor with opaque material. Application issues and certain patient conditions can affect the measurements of the monitoring system and cause the loss of the pulse signal. Anemia - Anemia causes decreased arterial oxygen content. Although SpO2 readings may appear normal, an anemic patient may be hypoxic. Correcting anemia can improve arterial oxygen content. The monitoring system may fail to provide an SpO2 reading if hemoglobin levels fall below 5 gm/dl. Dysfunctional hemoglobins - Dysfunctional hemoglobins such as carboxyhemoglobin, methemoglobin, and sulfhemoglobin are unable to carry oxygen. SpO2 readings may appear normal; however, a patient may be hypoxic because less hemoglobin is available to carry oxygen. Further assessment beyond pulse oximetry is recommended.

• •

A variety of conditions can cause inaccurate sensor measurements. Incorrect application of the recommended sensor Placement of the recommended sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line Ambient light and/or electromagnetic interference Failure to cover the sensor site with opaque material when operating under high ambient light conditions Excessive patient movement Dark skin pigment

• • • • • • •

Intravascular dyes or externally applied coloring, such as nail polish or pigmented cream

Loss-of-pulse signal can occur for several reasons. Recommended sensor applied too tightly

• • • •

Inflation of a blood pressure cuff on the same extremity as the attached sensor Arterial occlusion proximal to the recommended sensor Poor peripheral perfusion

If patient movement presets a problem, try one or more of the following: Verify the recommended sensor is properly and securely applied.

• • • • •

Move the sensor to a less active site. Use an adhesive sensor that improves patient skin contact. Use a new sensor with fresh adhesive backing. Keep the patient still, if possible.

If patient has poor perfusion, consider using the Nellcor™ forehead SpO2 sensor (MAXFAST), which provides superior detection in the presence of vasoconstriction. Nellcor™ forehead SpO2 sensors work particularly well on supine patients. During low perfusion conditions, Nellcor™ forehead SpO2 sensors reflect changes to SpO2 values up to 60 seconds earlier than digit sensor. 3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 9 SpO2 Setup SpO2 Parameter Box Display

The SpO2 display 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 and pulse rate are updated once per second.

SpO2 Target Setup 1.

Press the SpO2 Target Box on the Home screen or select the Patient menu to set the SpO2 target.

2.

Press the %SpO2 Target parameter box on the touch screen, and set the patient’s target SpO2 using the settings control knob. Set the Target Range by pressing the %SpO2 Upper and Lower Range parameter boxes on the touch screen, and set the percent difference from the %SpO2 Target using the settings control knob.

3.

NOTE: Setting the Target Range does not change the SpO2 Target. This setting only adjusts the time in range calculation when reviewing trends.

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3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

Section 10 %O2 Setup Goal and purpose: The automatic %O2 control system uses the patient’s measured SpO2 values to control the delivery of %O2 based on patient need. When the automatic %O2 control mode is enabled, the system tries to maintain the patient’s SpO2 level at or near a preconfigured SpO2 target (see also Further Reading). 1.

Select the Patient menu to set the %O2 Mode.

2.

Press the Backup %O2 parameter box on the touch screen, and set the patient’s Backup %O2 using the settings control knob. Note: See description of Fallback %O2 Functionality 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 O2 Mode AUTO button to put the device into Auto Mode (default is Manual). Note: To enable Auto %O2 Mode, 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 %O2 titration based on the patient’s SpO2 level and the set %SpO2 Target. %O2 delivered by the Precision Flow can range from 21-100%, unless a %O2 Limit is set. Delivered %O2 can be seen on the Precision Flow display, or on the Oxygen Assist Module Home Screen graphical trend display.

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 10 %O2 Setup Fallback %O2 Functionality For short instances of invalid or unreliable SpO2 readings, an error message is displayed that reflects the error condition and the Oxygen Assist Module will continue to deliver the calculated %O2 until the SpO2 reading becomes valid and reliable. While the SpO2 signal is invalid or unreliable, the %O2 delivery is set to the greater of the following:

• • •

The Backup %O2 setting. The Baseline %O2 setting, algorithm calculated as the value needed to keep the patient at SpO2 set point during the period the Oxygen Assist Module was in Auto %O2 Mode. The median value of the last three Auto %O2 values delivered prior to the SpO2 failure.

The Oxygen Assist Module automatically exits the Auto mode under the following circumstances:

• •

Clinical staff changes %O2 settings at the Precision Flow. The Oxygen Assist Module behaves according to Auto Mode Override setting. The Oxygen Assist Module detects invalid or unreliable SpO2 reading 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.

Section 11 System Shutdown 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.

Section 12 Graphical Trend Display 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.

Section 13 Logging of Variables 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.

• • •

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Date and Time O2 Mode SpO2 Target 3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

Section 13 Logging of Variables • SpO • %O • Pulse Rate • Percent Modulation • O2 Alarm Limit • Flow (L/min) • Temperature 2

2

Section 14 Cleaning and Disinfecting 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 SpO2 sensor and patient cable, see the instructions provided with the sensor.

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

Section 17 Referenced Documentation Precision Flow Instructions for Use can be found at our website www.vapotherm.com 3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 18 Troubleshooting and Support General If you need assistance with the Oxygen Assist Module of Vapotherm system, please contact Vapotherm Technical Support at TS@vtherm.com. 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 TS@vtherm.com). Prior to use, perform a visual inspection of the display, casing, and wires to confirm there is no visible damage.

Troubleshooting: SpO2 Probable Cause

Action Check the sensor Instructions for Use to confirm appropriate usage and proper application. Check sensor and interface cable connections. Test the sensor on another patient and/or try another sensor or interface cable.

The Pulse Search is reported for more than 10 seconds (before any measurements take place).

Perfusion may be too low for the module to track the pulse. Check the patient. Test the module on someone else. Change the sensor site. Try another type of Nellcor™ sensor. Interference may be preventing the module from tracking the pulse. Keep the patient still, if possible. Verify that the sensor is securely applied and replace it if necessary. Change the sensor site. Electromagnetic interference may be preventing the module from tracking the pulse. Remove the source of interference and/or try to stabilize the environment. Use a type of sensor that tolerates more patient movement; for example, a Nellcor™ adhesive sensor. The sensor may be too tight, there may be excessive ambient light, or the sensor may be on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. Reposition the sensor as necessary. Check the status of the patient. Perfusion may be too low for the module to track the pulse. Test the monitoring system on another patient. Change the sensor site and/or try another type of Nellcor™ sensor.

The Pulse Search is reported after successful measurements occur.

Interference may be preventing the module from tracking the pulse. Verify the sensor is securely applied and replace it if necessary. Change the sensor site. Use a type of sensor that tolerates more patient movement; for example, an Nellcor™ adhesive sensor. Electromagnetic interference may be preventing the monitoring system from tracking the pulse. Remove the source of interference and/or try to stabilize the environment. The sensor may be too tight, there may be excessive ambient light, or the sensor may be on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. Reposition the sensor as necessary.

Monitor appears functional, but is not registering patient data.

Ensure pulse oximetry sensor and interface cable are both Nellcor™ products.

Patient data appears suspect.

Reset the module.

Intermittent or corrupt patient data.

Reset the module.

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If interference is being reported ensure Nellcor™ sensor is firmly connected and patient remains still. Check if loss-of-pulse is being reported; ensure Nellcor™ sensor is firmly connected. Check sensor and interface cable connections. Check sensor and interface cable connections. 3101888-EN Rev C 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

Battery:

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. Li-ion, 34-37 Wh, internal

External Battery Charger:

N/A

Power:

Environment Ambient Temperature: 18-30°C Operation:

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 SpO2 sensor and Precision Flow O2 cannula

Liquid Ingress Protection:

IPX2 – Drip-proof

Alarm Sound Pressure

Medium Priority Alarm 65dBA maximum at volume setting 10

Operating Altitude

2000 meters

Inputs Sensors: External Device Communication:

SpO2 connector for Nellcor patient interface 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.

3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use

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Section 19 Specifications Standards IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) IEC 60601-1-10:2007, AMD1:2013 for use in conjunction with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012

Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance Medical Electrical Equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral standard: Requirements for the development of Physiologic Closed-loop Controllers (FDA Consensus Standard FR Recognition Number 19-9)

IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)

Medical Electrical Equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability

IEC 60601-1- 8: 2006 (Second Edition) + Am.1: 2012 for use in conjunction with IEC 60601-1: 2005 (Third Edition) + Am.1: 2012

Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-2. Ed. 4.0 (2014-02)

General requirements for safety – Collateral standard: Electromagnetic Compatibility – Requirements and tests

ISO 80601-2-61:2017, COR1:2018 for use IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012

Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

IEC 62304:2006 (First Edition) + A1:2015 (or IEC 62304:2015 CSV)

Medical device software: Software Life cycle processes

IEC 62366-1:2015

Medical devices – Part 1: Application of usability engineering to medical devices

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3101888-EN Rev C Vapotherm Oxygen Assist Module Instructions for Use