HVT2.0 IFU.pdf

HVT 2.0

High Velocity Therapy System

Instructions for Use

Page 2 HVT 2.0 Instructions for Use 43000655 Rev A

The screen images shown in this IFU may not match the layout of the screen on your device due to configurable parameters the user may have selected during set-up of the device.

HVT 2.0 Instructions for Use 43000655 Rev A Page 3

Table of Contents Section 1: Indications, Warnings & Precautions

Indications / Intended Use

Contraindications

Warnings & Precautions

General Warnings General Precautions

Section 2: Overview of the HVT 2.0 System

Features of the HVT 2.0 System

Principles of Operations

HVT 2.0 Device Disposable Components Accessories

Section 3: Setting Up the HVT 2.0 System

Assemble the HVT 2.0 Device for Use

Set up the Transfer Upgrade Kit

HVT 2.0 Initial Device Setup Process

HVT 2.0 Device Settings

Circuit Details Event Log Oxygen Source Preheat Water Therapy Presets Software Update

Section 4: Using the HVT 2.0 system

Modes of Operation overview

Start-Up Preparation

Page 4 HVT 2.0 Instructions for Use 43000655 Rev A

Starting Therapy

Initiate and Start Therapy Select Patient Interface Type Select Therapy Parameters Adjust Therapy Parameters with an Oxygen Concentrator

Stop Therapy

Discontinue Therapy Shut Down

Intra-Hospital Patient Transfer

How to Transfer a Patient

Section 5: Alarms & Advisories, Hospital/Clinician Use

Alarms & Advisories Overview

What to do if an Alarm or Alert Occurs Alarm System Functionality Verification How to get Information about an Alarm Multiple Alarms - Medium Priority and Low Priority Table: Medium Priority Alarms Table: Low Priority Alarms Table: Information Advisories Water Level Sensing

Section 6: Training

Section 7: Maintenance & Disinfection

Preventive Maintenance

Inspect the Power Supply Cord Inspect the Chassis Vent and Cooling Fan Replace the Patient Air Intake Filter Replace the Internal Safety Battery

Cleaning & Disinfection

Disposal Instructions

HVT 2.0 Device Disposal Patient Circuit and Accessories Disposal

Service

Software Updates

HVT 2.0 Instructions for Use 43000655 Rev A Page 5

Appendices Appendix A – Nurse Call System Installations ..............................A-1

Nurse Call Installation Instructions .........................................................A-2

Introduction ....................................................................................................... A-2 Scope ................................................................................................................... A-2 Nurse Call Hardware Interface Description ................................................. A-2 Installation Verification Procedure ................................................................ A-2

Appendix B – Electronic Medical Records (EMR) Integration ... B-1

Appendix C – Technical Specifications ............................................C-1

Physical Characteristics.....................................................................................C-1 System Requirements .......................................................................................C-1 Environment .......................................................................................................C-1 Performance .......................................................................................................C-2 Useful Life ...........................................................................................................C-2 Use with Oxygen Concentrators ....................................................................C-3 Inputs ..................................................................................................................C-3 Outputs ..............................................................................................................C-3 Bidirectional Connectivity ...............................................................................C-3 Minimum Alarm Sound Pressure Ranges ....................................................C-4 Available Parameter Settings and Factory Defaults ..................................C-4 Cybersecurity .....................................................................................................C-4 Standards/References .....................................................................................C-5 Guidance and Manufacturer’s Declaration ................................................C-5

Appendix D: Software Update Process ...........................................D-1

Appendix E: Symbol & Icon Key ....................................................... E-1

Device Screen Icons...........................................................................................E-1 Labeling Symbols ............................................................................................. E-2

Appendix F: Glossary ........................................................................... F-1

Terms .................................................................................................................... F-1

Warranty ..................................................................................................F-2

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Section 1: Indications, Warnings & Precautions The HVT 2.0 high velocity therapy system consists of the HVT 2.0 device and a Disposable Patient Circuit (DPC).

The HVT 2.0 system is equipped with an internal air blower. The addition of an external oxygen source (wall, tank, or oxygen concentrator) enables FiO2 delivery from 21% to 100%, dependent on the oxygen source.

The HVT 2.0 system is intended to be used by qualified medical professionals, such as physicians, nurses, respiratory therapists.

Accessories may not be available in all countries. Contact the local Vapotherm representative for more information.

If there is a serious incidence with the device, it should be reported to Vapotherm Technical Support at the number specified on the final page of the IFU or to your Authorized Vapotherm Representative. Follow local regulations and report the incidence to the competent authority or regulating agency.

Indications / Intended Use The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult, pediatric, and infant patients (5 kg and up).

The device is intended to be used in hospital, skilled nursing facilities, and sub-acute facilities.

Contraindications

• Not appropriate for patients who are not spontaneously breathing, are unable to protect their airway, or have anatomic or injury-induced blockage of the nasal pathway to the nasopharyngeal space.

• Not for treating OSA and snoring.

• HVT 2.0 is not for field transport.

• HVT 2.0 is MRI unsafe. Do not use it in an MR environment.

Page 8 HVT 2.0 Instructions for Use 43000655 Rev A

Warnings & Precautions Please take the time to review and become familiar with the warnings, precautions, and notes listed in this Instructions for Use document. They cover safety considerations, special requirements, and regulations. Warnings and precautions must be understood by the user to prevent adverse events to the patient or to the operator due to electromagnetic disturbances.

The user of this product shall have sole responsibility for any malfunction due to operation or maintenance errors by unauthorized/untrained personnel. Federal Law (U.S.) restricts the sale of this device to or by order of a physician. This device should be used only by a trained operator.

WARNING PRECAUTION NOTE

A Warning indicates that a situation may occur which is potentially harmful to the patient or user.

A Precaution 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.

General Warnings

• HVT 2.0 is not a Continuous Positive

Airway Pressure (CPAP) device. There are no controls to deliver or monitor airway pressure. HVT 2.0 should not be used to deliver pressure in a closed system.

• Patients receiving supplemental oxygen are often acutely ill and appropriate clinical vigilance should be observed by the care team. Additional patient monitoring, including pulse oximetry, is necessary if the HVT 2.0 is used to give supplementary oxygen.

• Use only the accessories, transducers, and cables specified or provided by the manufacturer of this equipment. Use of other accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

• Do not add any attachments or accessories to the HVT 2.0 system that are not listed in this Instructions for Use. The HVT 2.0 device might not function correctly, which could affect the quality of the therapy or could cause harm to the patient.

• Oxygen supports combustion. This device should not be used near open flames, flammables, oil, or grease. The device is not intended for use in oxygen-rich environments.

• Do not use the device in or around water (with the exception of the water bag that feeds the system).

• The oxygen must be clean, dry, medical-grade gas to prevent harm to the patient and to prevent damage to the device.

• Improperly sizing the cannula, specifically complete occlusion of the nares by the nasal prongs, may lead to a risk of pneumothorax.

• Cannula prongs should not obstruct more than 50% of the nares of the patient.

• Change nasal cannulas when soiled.

Replace cannulas according to clinical judgment and hospital policy but not to exceed 30 days continuous use.

• If used with an oxygen concentrator, the maximum oxygen percentage will be limited depending on the type of concentrator used and total set flow.

HVT 2.0 Instructions for Use 43000655 Rev A Page 9

General Warnings (continued)

• Only use sterile or distilled water. Failure to utilize sterile or distilled water supply or clean oxygen source may increase the risk of bacterial contamination.

• In specific countries, this device can be used to deliver nebulized medications inhaled through the nasal cannula and patient circuit.

• Always follow aseptic technique (including proper hand washing and avoiding direct hand contact with connection points) when setting up the HVT 2.0 device and use Standard Precautions when placing on a patient.

• Use with magnetic resonance imaging (MRI) and radio frequency (RF) equipment may cause patient injury.

• Medical electrical equipment needs special precautions regarding radio frequency (RF) electromagnetic radiation.

Portable and mobile RF communications equipment such as base stations for cordless telephones and land mobile radios, amateur radio and AM and FM radios, can affect medical equipment and should not be used near the device.

• If the HVT 2.0 system is placed in close proximity to RF emitters, an indication that HVT 2.0 performance is being affected by the emitters is false alarms and front panel display showing values that are out of specification. In certain circumstances, HVT 2.0 may affect or be affected by nearby equipment due to electromagnetic interference. If this should happen, try moving the HVT 2.0 device or moving the device causing interference or consult with the manufacturer.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the HVT 2.0 system, including specified cables. Otherwise, degradation of the performance of this equipment could result.

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating correctly.

• Use only the power supply cord that was provided with the device. Do not use any other cord. Do not use extension cords.

• Do not operate the device if the power supply cord is damaged.

• The power supply cord can be disconnected to isolate the product from mains. It is recommended that the device be unplugged when not in use to prevent hazards occurring when unattended.

• Do not modify this equipment without authorization from the manufacturer.

• HVT 2.0 is MR Unsafe and is not intended for use in MRI environments. Keep away from magnetic resonance imaging (MRI) equipment.

• Do not connect any device, system, or accessory that has not been approved by Vapotherm.

• Do not use the HVT 2.0 device at an altitude above 3000m or outside a temperature of 18 to 30°C. Using the device outside of this temperature range or above this altitude can affect the quality of the therapy or harm the patient.

• To prevent disconnection of the tubing or tubing system during use, especially during ambulatory use, only tubes in compliance with ISO 5367 or ISO 80601-2- 74 should be used.

• The device should not be turned on and left unattended when not connected to a patient.

• Before cleaning and disinfecting, unplug the device from line power.

• General Fault alarms are failures in the control or measurement systems.

Depending on the cause of the failure, gas delivery may or may not be interrupted. If a General Fault alarm occurs, disconnect the patient, and shut off the device. The device must be repaired by trained service personnel.

• To reduce the risk of strangulation from patient tubing, use the provided tubing clip to secure the patient tubing.

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General Warnings (continued)

• The internal safety battery is designed for temporary use only when AC or external DC power to the unit has been interrupted, and no transfer battery is present. When the HVT 2.0 device is running on the internal safety battery, there is no heat or humidity provided with the set flow and FiO2 and the humidity level may drop below safe limits. After the internal safety battery is fully discharged, the device will not operate, and patient gas flow will cease. When fully charged, the internal safety battery provides at least 15 minutes of power. The internal safety battery is not intended for patient transport.

• All disposable components are labeled as “single patient use only” and must be replaced after 30 days of use on a single patient. Cannulas should be replaced according to clinical use, but not to exceed 30 days. Do not attempt to sterilize or reuse any of these components, and follow all local and federal regulations for disposal. Outside the U.S., follow national or international regulations.

• Do not use disposables on more than one patient. Multi-patient use may lead to patient injury from infection and/or delivery of therapy outside of published specifications.

• To reduce the risk that the patient may aspirate condensed water from the breathing circuit, regularly observe the patient and output of the patient interface for excess water, and if detected remove patient interface from the patient. Water in the center lumen can result from condensation or due to a leak from the outer lumens that surround the breathing circuit. Condensation in the cannula may also occur in certain ambient conditions and low flow rates.

If minimal condensation occurs after confirming no leaks, it is recommended to select a lower temperature setpoint.

General Precautions

• HVT 2.0 will not operate without the internal safety battery in place. Have an internal safety battery on hand to ensure the continued availability of the use of the device. To ensure safe and reliable operation, use only the Vapotherm specified replacement battery.

• Do not ɖ cover the device (blocking the vent may damage the device) ɖ immerse the device in water ɖ steam or gas sterilize the device.

• Even a fully charged battery will lose its charge over a period of weeks when the device is not connected to line power.

It is recommended that the device be connected to line power at least 2 hours a month to maintain the battery charge.

The internal safety battery should only be accessed or replaced by trained service personnel.

• Do not use bleach, organic solvents, or abrasive cleaners. Hypochlorite solutions liberate toxic gases such as chlorine when acidified or heated. The reaction with ammonia or with substances that can generate ammonia can produce chloramines which are also toxic and have explosive potential.

NOTE: Flexible sterile or distilled water supply is recommended. If rigid or semi-rigid bottles are used, a Vapotherm-approved venting bottle cap spike must be used.

NOTE: HVT 2.0 may be operated with a limited performance at oxygen inlet pressures as low as 4 psi (28 kPa). However, for the full specified range of gas flows and oxygen percentages, oxygen inlet pressures must be 40 psi (276 kPa) or above (Caution:

Not to exceed 65 psi).

HVT 2.0 Instructions for Use 43000655 Rev A Page 11

Section 2: Overview of the HVT 2.0 System The HVT 2.0 high velocity therapy system consists of the HVT 2.0 device and a Disposable Patient Circuit (DPC).

While the HVT 2.0 device can be used over again on another patient, each patient will require a Disposable Patient Circuit (DPC) and nasal cannula, which are attached to the HVT 2.0 device and enable the delivery of high velocity therapy to the patient.

The ProSoft nasal cannula is proprietary to Vapotherm and the HVT 2.0. device will not work correctly unless using ProSoft cannulas.

Other accessories validated for use with the device are the roll stand, the Transfer Upgrade Kit, and the HVT 2.0 Nurse Call Interface Cable and the HVT 2.0 EMR Link Cable.

l

Figure 1: HVT 2.0 Device (above) and LED indicators on front of device

Page 12 HVT 2.0 Instructions for Use 43000655 Rev A

Features of the HVT 2.0 System

• Flow range from 5 to 45 L/min BTPS.

• Oxygen percentage is fully adjustable when connected to a 40 psi (276 kPa) oxygen gas source (non-oxygen concentrator).

• Temperature can be adjusted from 33 to 39°C.

• Built-in oxygen/air blender.

• All internal sensors are self-calibrating and self-monitoring.

• Flow, oxygen, and temperature settings are adjusted via touch screen scroll bars.

• Built-in electronic flow meters and controllers.

• Minimal downtime between patients: less than ten minutes to change disposables and disinfect.

• Warm-up time less than five minutes.

• Preheat feature circulates water and warms the circuit water to 33°C.

• EMR and Nurse Call connectivity capable of indicating an alarm condition on a hospital Nurse Call system and interfacing with Electronic Medical Record technologies.

• The Disposable Patient Circuit (DPC) is detachable and disposable: no disinfection necessary.

• A single DPC enables the full system flow range (5 to 45 L/min). The DPC is fully assembled and ready to use out of the packaging.

• Universal power requirements allow use anywhere with only a change of power cord.

• Internal safety battery maintains flow and oxygen percentage for at least 15 minutes if AC or external DC power is cut off. Safety battery recharges in 2 hours.

HVT 2.0 Instructions for Use 43000655 Rev A Page 13

Principles of Operations The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows up to 45 L/min to spontaneously breathing patients, without the need for wall air or any pressured air source. The device incorporates a proportional valve and flow sensors that allow the oxygen percentage and total gas flow to be set independently.

The HVT 2.0 system consists of two parts: the HVT 2.0 device and the Disposable Patient Circuit (DPC). A validated patient interface (e.g., Vapotherm ProSoft nasal cannula) is required to deliver therapy to the patient. In addition, there are optional accessories that can be added to the therapy based on a patient’s needs.

HVT 2.0 Device The HVT 2.0 device contains all the electrical and electronic components, including the proportional valve and flow controllers and remote sensors to monitor the disposable water path. The device has no water pathways, and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection.

The flow of oxygen and air is measured by mass flow sensors. The operating software calculates the required flow of each needed to reach the target flow and oxygen percentage set by the operator. The system controls gas flows accordingly by adjusting proportional solenoid valves on the gas line.

Firmware running in the device uses sensors to monitor gas pressure and water temperature. Alarms are activated if any parameters are outside the normal range.

Troubleshooting instructions for the alarms can be immediately displayed on the screen. Other indicators show a low charge in the internal safety battery.

After a two-hour charging period, the internal safety battery will maintain the set flow and oxygen blend for at least 15 minutes should AC, or external DC power be interrupted.

WARNING: The internal safety battery is designed for temporary use only when AC or external DC power to the unit has been interrupted, and no transfer battery is present. When the HVT 2.0 device is running on the internal safety battery, there is no heat or humidity provided with the set flow and FiO2 and the humidity level may drop below safe limits. After the internal safety battery is fully discharged, the device will not operate, and patient gas flow will cease.

When fully charged, the internal safety battery provides at least 15 minutes of power. The internal safety battery is not intended for patient transport.

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Disposable Components The following disposable components are compatible with HVT 2.0:

• Disposable Patient Circuit (DPC) [REQUIRED] – Single disposable patient circuit that enables delivery of high velocity therapy for adult, pediatric, and infant patients, for flows 5 to 45 L/min. The DPC is provided fully assembled and ready to use.

• ProSoft® Nasal Cannula [REQUIRED]– Various sizes are available so that a cannula can be selected to fit the patient comfortably. The cannula is connected to the DPC.

• Tubing Adapter - (optional) Available should the therapy need to be delivered through a trach mask or t-piece instead of the nasal cannula.

All disposable components are labeled as “single patient use only” and must be replaced after 30 days of use on a single patient. Cannulas should be replaced according to clinical use, but not to exceed 30 days. Do not attempt to sterilize or reuse any of these components, and follow all local and federal regulations for disposal.

Outside the U.S., follow national or international regulations.

WARNING: All disposable components are labeled as “single patient use only” and must be replaced after 30 days of use on a single patient. Cannulas should be replaced according to clinical use, but not to exceed 30 days. Do not attempt to sterilize or reuse any of these components, and follow all local and federal regulations for disposal. Outside the U.S., follow national or international regulations.

WARNING: Do not use disposables on more than one patient. Multi-patient use may lead to patient injury from infection and/or delivery of therapy outside of published specifications.

HVT 2.0 Instructions for Use 43000655 Rev A Page 15

HVT 2.0 Disposable Components

Disposables Patient Weight (kg) / Age Flow

Range (L/min)

5 - 10 kg ≥ 1 mo

10 - 20 kg ≥ 1 mo - 6 yrs

20 - 40 kg ≥ 6 - 18 yrs

> 40 kg > 12 yrs

>100 kg > 12 yrs

Disposable Patient Circuit (DPC)

Air/O2 (Standard) X X X X X 5-45

Cannulas

ProSoft Adult Long

X 5-45

ProSoft Adult X 5-45

ProSoft Adult Small/Pediatric

X 5-45

ProSoft Pediatric Small

X 5-20

ProSoft Intermediate Infant

X 5-8

ProSoft Infant X 5-8

Optional add-on

Tubing Adapter X X X X X 8-45

WARNING: Cannula prongs should not obstruct more than 50% of the nares of the patient.

NOTE: When delivering therapy to pediatric patients (via a nasal cannula or the tubing adapter), the recommended guidance for setting starting flow rate is 2 L/min/kg. See “Performance” on page C-2 for humidification output at specific flow rates.

NOTE: The Tubing Adapter is not intended to be connected directly to a trach collar.

An open system must be maintained to ensure gas egress. To facilitate humidification via a bypassed upper airway, connect to a tracheostomy mask or T-piece.

Page 16 HVT 2.0 Instructions for Use 43000655 Rev A

Accessories

• Roll Stand – rolling stand to hold the HVT 2.0 device.

• Transfer Upgrade Kit – to allow for moving the patient from one location to another within the hospital, includes:

ɖ Transfer Battery - 1-hour Lithium-ion battery (VTBP-2.0, 14.4Vdc; 2 x6900mAh;

2 x99.4 Wh) ɖ Oxygen manifold ɖ Oxygen hoses (U.S. Only) ɖ Adjustable oxygen tank holder (fits tank up to E-cylinder size)

• HVT 2.0 Nurse Call Interface Cable (2.9m) – to allow connectivity to the hospital Nurse Call System.

• HVT 2.0 EMR Link Cable (2.9m) – to allow interface with the hospital Electronic Medical Record System.

WARNING: Use only the accessories, transducers, and cables specified or provided by the manufacturer of this equipment. Use of other accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

WARNING: Do not add any attachments or accessories to the HVT 2.0 system that are not listed in this Instructions for Use. The HVT 2.0 device might not function correctly, which could affect the quality of the therapy or could cause harm to the patient.

HVT 2.0 Instructions for Use 43000655 Rev A Page 17

Section 3: Setting Up the HVT 2.0 System The following steps must be taken in preparation for using the HVT 2.0 System:

1. Assemble the HVT 2.0 device for use (including the Transfer Upgrade Kit, if applicable). (See details below).

2. Complete the Initial Setup of device settings. (See “HVT 2.0 Initial Device Setup Process” details below).

3. Insert the Disposable Patient Circuit (DPC) unit. Note: The DPC is provided fully assembled and ready to use.

4. Select the patient and interface type.

5. Connect the HVT 2.0 device to the patient.

Assemble the HVT 2.0 Device for Use

1. Attach the HVT 2.0 device securely to the sturdy roll stand or place it on a tabletop. See “Appendix C – Technical Specifications” for the roll stand dimensions.

2. Visually check that the patient air filter is installed. (The HVT 2.0 device comes with one pre-installed, and there is a replacement in the user kit).

3. [Optional] Install the Transfer Upgrade Kit. For step-by-step instructions, see the “Set up the Transfer Upgrade Kit” section below.

4. Insert power supply cord into a facility-approved wall outlet.

WARNING: Do not operate the device if the power supply cord is damaged.

WARNING: The power supply cord can be disconnected to isolate the product from mains. It is recommended that the device be unplugged when not in use to prevent hazards occurring when unattended.

WARNING: Use only the power supply cord that was provided with the device. Do not use any other cord. Do not use extension cords.

Page 18 HVT 2.0 Instructions for Use 43000655 Rev A

5. Connect the oxygen hose to the oxygen inlet at the back of the device or tubing if using an oxygen concentrator.

6. If applicable, connect the Nurse Call cables to the appropriate port on the back of the HVT 2.0 device.

Once connected, the Nurse Call System will be enabled.

See “Appendix A – Nurse Call System Installations” for complete instructions for use on connection and use of Nurse Call.

If available, connect the EMR system. See “Appendix B – Electronic Medical Records (EMR) Integration” for more information.

Set up the Transfer Upgrade Kit Setting up the Transfer Upgrade Kit involves four (4) steps:

1. Insert the Transfer Battery into the HVT 2.0 device.

2. Attach the oxygen manifold to the Roll Stand.

3. Connect the oxygen hoses to their appropriate locations per the labels on each hose.

4. Attach the tank holder to the Roll Stand.

For more information on transferring patients, see “Intra-Hospital Patient Transfer” on page 43.

NOTE: The maximum weight capacity of the roll stand when equipped with the transfer kit is 40 kg. The basket has a maximum weight capacity of 5 kg.

Figure 2: Roll Stand

HVT 2.0 Instructions for Use 43000655 Rev A Page 19

HVT 2.0 Initial Device Setup Process There is a five-step process for initial setup for the HVT 2.0 device. Note: Initial setup screens will only appear when powering on the dervice for the first time or after Factory Reset is selected (from the Admin Settings menu).

“Step 1: Set up Language”

“Step 2: Set up Date & time”

“Step 3: Set up Admin passcode”

“Step 4: Set up Therapy presets”

“Step 5: Set up Device preferences”

Step 1: Set up Language On the Set device language screen, tap the language button from the language options displayed.

NOTE: Changing the language will restart (reboot) the system after you confirm the change in language. Figure 3: Language setting

Step 2: Set up Date & time Set up the device date/ time.

Note: The time is in the 24-hour format (e.g., no AM or PM).

Figure 4: Date & time setting

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Step 3: Set up Admin passcode Create the 4-digit Admin passcode.

The passcode must be confirmed by inputing it twice in order to continue the setup process. If the passcodes do not match, a message will display and the passcode must be re-entered.

Figure 5: Admin passcode setting

Step 4: Set up Therapy presets Set up therapy presets.

Figure 6: Therapy presets setting

Step 5: Set up Device preferences Set up the device preferences.

Figure 7: Device preferences settings

HVT 2.0 Instructions for Use 43000655 Rev A Page 21

HVT 2.0 Device Settings The HVT 2.0 device has a number of settings that can be accessed and adjusted, if necessary. These settings can be adjusted from the Settings menu.

To access the Settings menu:

1. Tap the [Unlock] button at the top left corner of the main screen.

The [Unlock] button will be replaced by a [Lock] button, and a [Menu] button will display next to it.

2. Next, tap the [Menu] button to display the Settings menu.

Figure 8: Tap the [Unlock] button to access Settings [Menu] button

The [Menu] button enables users to access the General Settings and Admin Settings in order to establish settings for the device in both Standby and Run modes.

The following settings can be defined from the General Settings menu:

• Circuit details – Select the patient interface (trach adapter or cannula size).

See”Circuit Details” on page 23 for more details on this feature.

• Screen brightness – Set the desired screen brightness level.

• Audio volume – Set the volume level of the alarms.

• Event log - Displays all events captured on the device, including event details, date and time. See”Event Log” on page 23 for more details on this feature.

• Oxygen Source – Select the source of the oxygen that will be connected to the device (e.g., Wall/tank or Concentrator). See”Oxygen Source” on page 24 for more details on this feature.

• Software details – Displays Controller board and GUI application software versions.

• Admin settings access – Enables user to open the Admin Settings menu.

The following settings can be defined from the Admin Settings menu:

• Preferences (includes Patient Type selection and Preheat)

• Preheat water - Enable the Preheat water mode, which circulates water and warms the circuit water to 33°C. See”Preheat Water” on page 25 for more details on this feature.

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• Therapy presets – Add or edit therapy preset configurations for Flow, Oxygen, and Temperature. See”Therapy Presets” on page 26 for more details on this feature.

• Date & time – Set the format for the device date and time.

• Language - Select the screen language.

• Calibrate water level - Activate water level calibration, only if advised by

Vapotherm to do so.

• Admin Passcode - The user is able to change the admin passcode.

• Software update – Update Controller board and GUI application software, when directed by Vapotherm personnel. See”Appendix D: Software Update Process” for more instructions on how to udate the device software

• Factory reset - The user is able to restore the device to factory settings from the Admin. Settings menu when not in therapy. Therapy must be stopped to reset the device. Select “Factory Reset” from the Admin Settings Menu. The Factory reset will reboot the device and display the”HVT 2.0 Initial Device Setup Process”.

NOTE on Screen Lock functionality:

The screen will lock automatically after 3 minutes of non-activity.

To unlock the screen, tap the [Unlock] button in the top left of the screen.

Figure 9: Screen Lock/Unlock

HVT 2.0 Instructions for Use 43000655 Rev A Page 23

Circuit Details

Select patient interface When you select Circuit Details from the General settings menu, the Select patient interface screen displays.

From the screen, select the correct cannula size or select Trach adapter for the patient.

Figure 10: Patient interface setting

Event Log

1. To access the Event Log, select [Event Log] from the General settings menu.

The Event Log can hold up to 2,000 events.

Figure 11: Event log - all events

2. To filter the list, tap the [Show button] above the Event listing table.

Events can be limited to a particular category, including:

• All events

• All alarms

• Therapy changes

• System changes

Figure 12: Event Log filter selection

Page 24 HVT 2.0 Instructions for Use 43000655 Rev A

Oxygen Source

Oxygen Source can be selected from the General settings menu.

1. Select the source of oxygen for the patient by tapping either the Wall/tank option or the Concentrator option.

Figure 13: Therapy presets setting

NOTE: When using an oxygen concentrator, refer to the Concentrator Flow Rate table in “Appendix C – Technical Specifications”- in the “Use with Oxygen Concentrator” section, for the estimated oxygen concentration.

2. If Concentrator is selected, the current O2 percentage and maximum flow rate will display. To make a change, tap on O2 concentration to select a new oxygen concentration percentage. To set the maximum flow rate, tap either 5 L/Min or 10 L/Min. A checkmark will display next to the selected flow rate. Figure 14: Oxygen source: Concentrator selected

3. The system will default to 92% oxygen concentration. If you need to change the oxygen concentration, tap the 92 and select the new percentage from the scroll bar.

4. Tap the [Confirm] button below the scroll bar to save the changes.

Figure 15: Concentrator - Scroll bar to change O2 changes

HVT 2.0 Instructions for Use 43000655 Rev A Page 25

Preheat Water Enabling the Preheat water mode circulates water and warms the circuit water to 33°C.

When the system is operating from AC power, preheat automatically starts after circuit priming completes or therapy is stopped.

Preheat Water is part of the Preferences option from the Admin settings menu.

The Preheat water mode is enabled during Initial Setup or can be enabled by selecting it from the Admin settings menu.

Once enabled, while the system is operating on AC power, the preheat water feature automatically starts.

A Preheat status bar will display on the screen.

Figure 16: Preheat status bar displays

Note that when the system operating power transitions from AC power to Transfer battery power, preheating the water can be activated via the [Warm-up] button that will display on the screen. Press the button to begin the pre-heat process.

Figure 17: Preheat warm-up button

Page 26 HVT 2.0 Instructions for Use 43000655 Rev A

Therapy Presets

1. From the Admin settings menu, tap the [Therapy Presets] button to display the screen.

2. The Therapy Presets settings allow you to set up two different therapy settings that are ready for quick initiation of therapy.

To create a preset, tap the [Edit] button to the right of the preset. Figure 18: Therapy presets

3. To select your preset values, select the Flow, FiO2, or Temp by tapping them.

Figure 19: Edit Therapy Preset

4. When the parameter is tapped, a scroll bar will display below

it. Use the scroll bar to select your target value(s) for each parameter: Flow, FiO2, or Temp.

Tap [Confirm] to save the value as a part of the preset.

Figure 20: Adjust settings - Therapy preset Flow target

HVT 2.0 Instructions for Use 43000655 Rev A Page 27

Software Update

From the Admin Settings menu, tap the [Software update] button to display the screen.

The screen will display the latest software versions and dates for the Controller board and Graphic User Interface (GUI) application.

NOTE: The button will only be enabled when a USB is placed in the back of the device. See “Appendix D:

Software Update Process” for sofware update instructions.

Figure 21: Software update selections

Page 28 HVT 2.0 Instructions for Use 43000655 Rev A

HVT 2.0 Instructions for Use 43000655 Rev A Page 29

Section 4: Using the HVT 2.0 system Modes of Operation overview HVT 2.0 has three modes of operation: Sleep, Standby, and Run. The mode displays at the top of the screen.

Figure 22: Modes of operation

Sleep: The device is plugged in but is not turned on. No therapy is being delivered.

Standby: The device is on, and the screen is illuminated. No therapy is being delivered.

This mode is indicated by either “NO CIRCUIT” (DPC is not installed) or “STANDBY” (DPC installed but therapy not started). To start therapy, tap the [Start therapy] button at the bottom of the screen.

Run: The device is on and delivering therapy according to the parameter’s setup. This mode is indicated by “RUNNING” being displayed at the top of the screen and the [Stop therapy] button at the bottom of the screen.

Start-Up Preparation Before assembling the device for use, make sure the following items are available:

ɖ Disposable Patient Circuit (DPC) ɖ Sterile or distilled water supply ɖ Validated patient interface (ProSoft nasal cannula or trach adapter) ɖ Adequate oxygen source and connectors

1. Visually inspect the power supply cord to verify that it is not damaged or kinked. Then, plug the power supply cord into a facility-approved wall outlet.

2. Connect the oxygen hose to the facility-approved oxygen wall outlet, oxygen tank, or an oxygen concentrator.

NOTE: When using an oxygen concentrator, a 1/4” barb nipple is required.

3. Press the [Power] button on the device. The screen will illuminate and display the software revision number and will automatically conduct the alarm sound test.

Page 30 HVT 2.0 Instructions for Use 43000655 Rev A

Starting Therapy

WARNING: The device should not be turned on and left unattended when not connected to a patient.

If the device has been exposed to very hot or very cold temperatures, allow it to reach operating temperature before use. After being exposed to extreme temperatures, the device can take up to 12 hours to reach room temperature.

The Start Therapy procedures have been divided into the following sections:

1. “Insert the Disposable Patient Circuit (DPC)”

2. “Select Patient Interface Type”

3. “Select Therapy Parameters”

4. “Start Therapy”

NOTE: Optional Therapy Presets or the ”Pediatric Flow Calculator” are available to select your therapy parameters.

Initiate and Start Therapy

Insert the Disposable Patient Circuit (DPC)

1. Insert the Disposable Patient Circuit (DPC) according to the illustrations below.

NOTE: The DPC is provided fully assembled and ready to use.

NOTE: If the device is not powered on, inserting the DPC will automatically power on the unit (if it is connected to wall power or transfer battery).

Figure 23: Insert the Disposable Patient Circuit (DPC) into the device.

HVT 2.0 Instructions for Use 43000655 Rev A Page 31

2. Hang the sterile or distilled water supply from the Roll Stand and connect it to the DPC via the water inlet tube. Spike the water supply and unclip the tubing, if necessary, to begin the flow of water to the device.

NOTE: When using some water bottles, it may be necessary to use a hook to lower and hang the water bottle (included in the user kit) to facilitate connection with the spike tube.

Flexible sterile or distilled water supply are recommended. If rigid or semi-rigid bottles are used, a Vapotherm-approved venting bottle cap must be used.

WARNING: Only use sterile or distilled water. Failure to utilize sterile or distilled water supply or clean oxygen source may increase the risk of bacterial contamination.

3. Next, select the patient interface type on the screen.

Selecting a cannula will lock in the flow range that the cannula is labeled for.

Figure 24: New circuit detected

Page 32 HVT 2.0 Instructions for Use 43000655 Rev A

Select Patient Interface Type

1. Select the desired patient interface type on the screen. If selecting a cannula, place the cannula on the patient to allow the cannula to warm to the patient’s skin temperature. This helps minimize condensation during therapy delivery.

NOTE: The Infant cannula selection includes both the infant and intermediate-sized cannulas. The Pediatric Small is limited to the pediatric small-sized cannula. And, the Pediatric/Adult cannula selection includes the Pediatric/Adult Small, Adult, and Adult Long-sized cannulas. [For more information on cannula sizes, see “HVT 2.0 Disposable Components” on page 15.].

WARNING: Cannula prongs should not obstruct more than 50% of the nares of the patient.

NOTE: If the flow rate was set prior to selecting the cannula, the device will verify that the flow rate is within the range permitted for the selected cannula. If it is not within the appropriate range, a message will display indicating either the flow rate needs to be lowered or a different patient interface type should be selected.

Sample screen message: Current flow (35 L/min) higher than selected cannula limit (20 L/ min). Selecting this cannula will decrease flow to 20 L/min.

2. Select an optional therapy preset or use the starting pediatric flow calculator by tapping [Pediatric flow calc]. For detailed instructions on using the Pediatric Flow Calculator, see “Pediatric Flow Calculator” on page 38.

NOTE: The pediatric flow calculator is intended to provide suggested starting flow rates for pediatric patients up to 13 years of age, and flow can be subsequently titrated to clinical effect.

NOTE: Select “none” to manually-adjust therapy parameters.

3. Tap to confirm cannula or Trach Adapter and preset settings.

Figure 25: Select and confirm patient and patient interface type

HVT 2.0 Instructions for Use 43000655 Rev A Page 33

4. The home screen will display the three therapy parameters and the message bar will display

“PRIMING”.

Figure 26: Priming in progress message

5. If the water is not circulating through the DPC when priming, the screen top banner will show an advisory to unclamp the water line.

Unclamp the water line to proceed.

Figure 27: Priming in progress message

6. Allow the DPC to prime with water before starting therapy. The device will indicate when priming is complete. It takes 60 seconds for a flexible sterile or distilled water supply to prime the DPC; it takes 180 seconds for rigid or semi-rigid water bottles to do so.

7. If you selected a Therapy Preset, your therapy settings will be automatically loaded and you can proceed to ”Start Therapy” on page 37.

Page 34 HVT 2.0 Instructions for Use 43000655 Rev A

Select Therapy Parameters If you did not select a therapy preset or use the pediatric flow calculator, follow the steps below to manually adjust the therapy settings.

1. To change the therapy parameters, first tap the [Unlock] button at the top left of the screen.

Figure 28: Unlock screen to change the settings

2. To set a therapy parameter, tap the parameter on the screen (Flow, FiO2, or Temp). A scroll bar displays allowing a new parameter target to be set.

3. For each parameter, select a setting from the horizontal scroll bar that displays.

The scroll bar allows you to slide to the left or right in order to find the right setting. Adjustments can be made to one or more of the parameters before saving the changes.

4. Tap the [Close] button to save the new therapy parameters. Figure 29: Setting FiO2 parameter using the scroll bar

NOTE on 100% FiO2 button:

While in therapy, a [100% FiO2] button is available. If pressed and confirmed, FiO2 is administered at 100% for 2 minutes.

Figure 30: 100% FiO2 button

HVT 2.0 Instructions for Use 43000655 Rev A Page 35

When the [100% FiO2] button is pressed and confirmed, FiO2 is administered at 100% for 2 minutes and a timer displays on the screen.

When the 2 minutes expire, the FiO2 setting returns to the initial setting.

NOTE: To stop administering 100% FiO2 before the 2 minutes expire, press and hold the “X” on the status bar for 2 seconds. Figure 31: 100% FiO2 timer displays

NOTE: When using an oxygen concentrator, the system will notify you of changes in delivered FiO2 as the Flow rate is titrated up.

[See “Adjust Therapy Parameters with an Oxygen Concentrator” for more details.]

Figure 32: Notification of changes in FiO2 as Flow rate changes

5. After setting the therapy parameters and when the temperature on the screen has reached at least 33°C, connect the patient’s cannula interface to the delivery tube.

NOTE: Check water level, temperature display, gas flow rate, and oxygen percentage.

Figure 33: Connect cannula to delivery tube

WARNING: Always follow aseptic technique (including proper hand washing and avoiding direct hand contact with connection points) when setting up the HVT 2.0 device and use Standard Precautions when placing on a patient.

Page 36 HVT 2.0 Instructions for Use 43000655 Rev A

WARNING: Cannula prongs should not obstruct more than 50% of the nares of the patient.

WARNING: Change nasal cannulas when soiled. Replace cannulas according to clinical judgment and hospital policy but not to exceed 30 days continuous use.

WARNING: Improperly sizing the cannula, specifically complete occlusion of the nares by the nasal prongs, may lead to a risk of pneumothorax.

WARNING: To reduce the risk that the patient may aspirate condensed water from the breathing circuit, regularly observe the patient and output of the patient interface for excess water, and if detected remove patient interface from the patient. Water in the center lumen can result from condensation or due to a leak from the outer lumens that surround the breathing circuit. Condensation in the cannula may also occur in certain ambient conditions and low flow rates.

If minimal condensation occurs after confirming no leaks, it is recommended to select a lower temperature setpoint.

NOTE: Droplets of condensation may appear at the end of patient delivery tube while unit is warming up. This is normal and will stop within a few minutes when set temperature is reached and the cannula is fitted to the patient.

NOTE: Some condensation around the nose is possible. In addition, a high moisture level may mobilize mucus from nose and sinuses. Make sure patient has a supply of facial tissues.

NOTE: Take precautions to minimize cooling of the unheated cannula by trying to maintain contact with the patient’s skin and insulating the exposed portion of the cannula with bedding.

HVT 2.0 Instructions for Use 43000655 Rev A Page 37

Start Therapy

1. Start therapy by tapping the [Start therapy] button at the bottom of the screen to begin delivering flow.

Figure 34: [Start therapy] button

2. After tapping the [Start therapy] button, the device is in Run mode.

This is indicated by the word “RUNNING” displayed at the top of the screen.

NOTE: If the target temperature has not been reached, the screen will also indicate the Actual versus Target temperatures as it monitors the status of the temperature. Figure 35: Device in Run mode

Page 38 HVT 2.0 Instructions for Use 43000655 Rev A

Pediatric Flow Calculator

The Pediatric Flow Calculator provides suggested starting flow rates for pediatric patients up to 13 years of age. It uses a patient’s weight and respiratory rate to calculate a suggested starting flow rate. This feature is accessible in Start Therapy when a DPC is inserted into the device.

1. If you tapped [Pediatric flow calc], the Pediatric Flow Calculator screen displays.

NOTE: The default measurement is kilograms (kg).

You can switch to pounds (lbs), if preferred, by tapping the [Switch to lbs] button.

2. To enter the patient’s weight, tap the Patient Weight tab on the screen. Figure 36: Pediatric flow calculator

3. A scroll bar will display. Use the scroll bar to select the patient’s weight.

4. Tap [Confirm] to save your patient weight selection.

Figure 37: Select and then confirm patient’s weight

5. To enter the patient’s current respiratory rate, tap the Patient respiratory rate tab.

6. A scroll bar displays.

Select the respiratory rate (breaths/minute) from the scroll bar.

7. Tap [Confirm] to save the respiratory rate selected. Figure 38: Select and confirm patient respiratory rate

HVT 2.0 Instructions for Use 43000655 Rev A Page 39

8. Tap [Set as current flow] if you want to use the provided value as the starting flow rate. Then tap [Confirm] to exit the screen and view the home screen.

If you do not want to use the suggested flow rate, tap the [<Back to patient interface selection] button to exit the pediatric flow calculator.

The suggested starting flow rate displays.

Figure 39: Confirm patient and patient interface type

9. If the suggested starting flow is higher than the currently selected cannula range, a notification will display.

10. To change the patient interface selection, tap the [<Back to patient interface selection] button. Make the change, then re-select the pediatric flow calculator by tapping [Pediatric flow calc] and follow the steps above.

Figure 40: Notification displays: Higher than cannula rate

NOTE on Therapy Adjustments: You can adjust any of the parameters (Flow, FiO2, and Temp) while the device is in Run mode. Simply tap the desired parameter on the screen and select the desired setting from the scroll bar that displays.

Figure 41: Adjusting Flow using the scroll bar

Adjustments can be made among any or all of the three parameters (Flow, FiO2, and Temp) before saving the changes.