High Velocity Therapy System HVT 2.0 Instructions for Use Rev C

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 or the software version of the device

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HVT 2.0 Instructions for Use 43000655 Rev C

Table of Contents Section 1: Indications, Warnings & Precautions... 7 Indications / Intended Use... 7 Contraindications...7

Warnings & Precautions... 8 General Warnings... 8 General Precautions... 10

Section 2: Overview of the HVT 2.0 System...11 Features of the HVT 2.0 System... 12 Principles of Operations... 13 HVT 2.0 Device... 13 Disposable Components... 14 Accessories... 16

Section 3: Setting Up the HVT 2.0 System... 17 Assemble the HVT 2.0 Device for Use...17 Set up the Transfer Upgrade Kit... 18 HVT 2.0 Initial Device Setup Process ... 19 HVT 2.0 Device Settings... 21 Circuit Details... 23 Event Log... 23 Oxygen Source... 24 Preheat Water... 25 Therapy Presets... 26 Software Update...27

Section 4: Using the HVT 2.0 system... 29 Modes of Operation overview...29 Start-Up Preparation... 29

HVT 2.0 Instructions for Use 43000655 Rev C

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Starting Therapy... 30 Initiate and Start Therapy... 30 Select Patient Interface Type... 32 Select Therapy Parameters... 34 Adjust Therapy Parameters with an Oxygen Concentrator... 38

Stop Therapy... 41 Discontinue Therapy... 41 Shut Down... 42

Intra-Hospital Patient Transfer...42 How to Transfer a Patient ... 43

Section 5: Alarms & Advisories, Hospital/Clinician Use... 44 Alarms & Advisories Overview... 44 What to do if an Alarm or Alert Occurs... 45 Alarm System Functionality Verification... 46 How to get Information about an Alarm... 46 Multiple Alarms - Medium Priority and Low Priority ...47 Table: Medium Priority Alarms ... 48 Table: Low Priority Alarms ... 50 Table: Information Advisories ... 50 Water Level Sensing... 51

Section 6: Training... 53 Section 7: Maintenance & Disinfection ... 53 Preventive Maintenance... 53 Inspect the Power Supply Cord... 54 Inspect the Chassis Vent and Cooling Fan... 54 Replace the Patient Air Intake Filter ... 54 Replace the Internal Safety Battery... 54

Cleaning & Disinfection... 55 Disposal Instructions...56 HVT 2.0 Device Disposal... 56 Patient Circuit and Accessories Disposal... 56

Service...56 Software Updates...56 Page 4

HVT 2.0 Instructions for Use 43000655 Rev C

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

Appendix G: Transfer and Ambulation Tank Table... G-1 Warranty... G-2

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HVT 2.0 Instructions for Use 43000655 Rev C

HVT 2.0 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 provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS). 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. • Not for use with an Oxygen Concentrator (when treating respiratory distress).

HVT 2.0 Instructions for Use 43000655 Rev C

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

PRECAUTION

NOTE

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.

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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.

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

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

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The oxygen must be clean, dry, medicalgrade gas to prevent harm to the patient and to prevent damage to the device.

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.

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

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

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

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.

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

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An Air Compressor is not to be used with the device.

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HVT 2.0 Instructions for Use 43000655 Rev C

General Warnings (continued) •

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

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

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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.

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•

•

• To avoid electric shock;

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.

HVT 2.0 Instructions for Use 43000655 Rev C

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

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

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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.

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Do not modify this equipment without authorization from the manufacturer.

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

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Do not use near or in water.

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Do not use if device is damaged.

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

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

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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.

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To prevent disconnection of the tubing or tubing system during use, especially during ambulatory use, only tubes in compliance with ISO 5367 or ISO 80601-274 should be used.

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

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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.

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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) •

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The internal safety battery is designed for temporary use only when AC 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.

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.

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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.

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

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.

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Do not

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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.

ɖ cover the device (blocking the vent may damage the device) ɖ immerse the device in water ɖ steam or gas sterilize the device.

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

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.

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, appropriate for treating respiratory distress, oxygen inlet pressures must be 40 psi (276 kPa) or above (Caution: Not to exceed 87 psi).

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HVT 2.0 Instructions for Use 43000655 Rev C

HVT 2.0 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.

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

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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 power is cut off. Safety battery recharges in 2 hours.

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HVT 2.0 Instructions for Use 43000655 Rev C

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 power be interrupted. WARNING: The internal safety battery is designed for temporary use only when AC 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.

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HVT 2.0 Instructions for Use 43000655 Rev C

HVT 2.0 Disposable Components Disposables

Flow Range

Patient Weight (kg) / Age 5 - 10 kg ≥ 1 mo

(L/min)

10 - 20 kg ≥ 1 mo - 6 yrs

20 - 40 kg ≥ 6 - 18 yrs

> 40 kg > 12 yrs

>100 kg > 12 yrs

X

X

X

X

5-45

X

5-45

Disposable Patient Circuit (DPC) Air/O2 (Standard)

X

Cannulas ProSoft Adult Long ProSoft Adult

X

ProSoft Adult Small/Pediatric

5-45

X

ProSoft Pediatric Small

5-45

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.

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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 (14.4Vdc; 2 x6800mAh; 2 x97.9 Wh) ɖ Oxygen manifold ɖ Oxygen hoses (U.S. Only) ɖ Adjustable oxygen tank holder (Use only 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.

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HVT 2.0 Instructions for Use 43000655 Rev C

HVT 2.0 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.

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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 42. 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

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HVT 2.0 Instructions for Use 43000655 Rev C

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 device 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 24hour 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 reentered.

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

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HVT 2.0 Instructions for Use 43000655 Rev C