Vapotherm HVT 2.0 Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Vapotherm Manuals
  4. Medical Equipment
  5. HVT 2.0
  6. Instructions for use manual

Vapotherm HVT 2.0 Instructions For Use Manual

High velocity therapy system
Hide thumbs
Table of Contents

Advertisement

Quick Links

HVT 2.0
High Velocity Therapy System
Instructions for Use

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the HVT 2.0 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Vapotherm HVT 2.0

Summary of Contents for Vapotherm HVT 2.0

  • Page 1 HVT 2.0 High Velocity Therapy System Instructions for Use...
  • Page 2 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 Page 2 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 3: Table Of Contents

    Contraindications ....................7 Warnings & Precautions ................General Warnings ..................8 General Precautions ..................10 Section 2: Overview of the HVT 2.0 System ........Features of the HVT 2.0 System ..............Principles of Operations ................HVT 2.0 Device ...................... 13 Disposable Components ..................14 Accessories ......................
  • Page 4 Replace the Internal Safety Battery ..............54 Cleaning & Disinfection ................Disposal Instructions ................... HVT 2.0 Device Disposal ..................56 Patient Circuit and Accessories Disposal ............56 Service ......................Software Updates ..................Page 4 HVT 2.0 Instructions for Use 43000655 Rev C...
  • Page 5 Appendix E: Symbol & Icon Key ............Device Screen Icons................... E-1 Labeling Symbols ..................... E-2 Appendix F: Glossary ................Terms ........................F-1 Appendix G: Transfer and Ambulation Tank Table ...... Warranty ....................HVT 2.0 Instructions for Use 43000655 Rev C Page 5...
  • Page 6 This page intentionally left blank. Page 6 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 7: 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 FiO delivery from 21% to 100%, dependent on the oxygen source.

  • Page 8: Warnings & Precautions

    • The oxygen must be clean, dry, medical- monitoring, including pulse oximetry, is grade gas to prevent harm to the patient necessary if the HVT 2.0 is used to give and to prevent damage to the device. supplementary oxygen. •...
  • Page 9 • Do not use if device is damaged. radios, amateur radio and AM and FM • HVT 2.0 is MR Unsafe and is not intended radios, can affect medical equipment and for use in MRI environments. Keep away should not be used near the device.

  • Page 10: General Precautions

    General Precautions • HVT 2.0 will not operate without the • Do not use bleach, organic solvents, or internal safety battery in place. Have an abrasive cleaners. Hypochlorite solutions...

  • Page 11: Section 2: Overview Of The Hvt 2.0 System

    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...

  • Page 12: Features Of The Hvt 2.0 System

    • 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. Page 12 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 13: Principles Of Operations

    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.

  • Page 14: Disposable Components

    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.
  • Page 15 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. HVT 2.0 Instructions for Use 43000655 Rev C Page 15...

  • Page 16: Accessories

    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.

  • Page 17: Section 3: Setting Up The Hvt 2.0 System

    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”...

  • Page 18: Set Up The Transfer Upgrade Kit

    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.

  • Page 19: Hvt 2.0 Initial Device Setup Process

    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).
  • Page 20 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 Page 20 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 21: Hvt 2.0 Device Settings

    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.
  • Page 22 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 Page 22 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 23: Circuit Details

    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 HVT 2.0 Instructions for Use 43000655 Rev C Page 23...

  • Page 24: Oxygen Source

    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. Page 24 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 25: Preheat Water

    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 HVT 2.0 Instructions for Use 43000655 Rev C Page 25...

  • Page 26: Therapy Presets

    Figure 18: Therapy presets the right of the preset. 3. To select your preset values, select the Flow, FiO , or Temp by tapping them. Figure 19: Edit Therapy Preset Page 26 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 27: Software Update

    The button will only be enabled when a USB is placed in the back of the Figure 21: Software update selections device. See “Appendix D: Software Update Process” for sofware update instructions. HVT 2.0 Instructions for Use 43000655 Rev C Page 27...
  • Page 28 This page intentionally left blank. Page 28 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 29: Section 4: Using The Hvt 2.0 System

    HVT 2.0 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.

  • Page 30: Starting Therapy

    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. Page 30 HVT 2.0 Instructions for Use 43000655 Rev C...
  • Page 31 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 HVT 2.0 Instructions for Use 43000655 Rev C Page 31...

  • Page 32: Select Patient Interface Type

    2. Select an optional therapy preset by tapping [Preset 1 or Preset 2]. NOTE: Select “none” to manually-adjust therapy parameters. Tap to confirm cannula or Trach Adapter and preset settings. Figure 25: Select and confirm patient and patient interface type Page 32 HVT 2.0 Instructions for Use 43000655 Rev C...
  • Page 33 DPC, including flexible, rigid, or semi-rigid water bags and bottles. If you selected a Therapy Preset, your therapy settings will be automatically loaded and you can proceed to ”Start Therapy” on page 37. HVT 2.0 Instructions for Use 43000655 Rev C Page 33...

  • Page 34: Select Therapy Parameters

    NOTE on 100% FiO button: While in therapy, a [100% FiO button is available. If pressed and confirmed, FiO is administered at 100% for 2 minutes. Figure 30: 100% FiO button Page 34 HVT 2.0 Instructions for Use 43000655 Rev C...
  • Page 35 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 HVT 2.0 Instructions for Use 43000655 Rev C Page 35...
  • Page 36 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. WARNING: Cannula prongs should not obstruct more than 50% of the nares of the patient.
  • Page 37 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 Figure 35: Device in Run mode temperature. HVT 2.0 Instructions for Use 43000655 Rev C Page 37...

  • Page 38: Adjust Therapy Parameters With An Oxygen Concentrator

    (Flow, Fi , and Temp). A scroll bar will Figure 37: Unlock screen to change the Flow, FiO , or Temp display, allowing a new settings parameter target to be selected. Page 38 HVT 2.0 Instructions for Use 43000655 Rev C...
  • Page 39 (see the message “FiO lowered to 56% due to high flow rate” on the screen below). Figure 39: System resets the oxygen percentage based on high flow rate HVT 2.0 Instructions for Use 43000655 Rev C Page 39...
  • Page 40 • Cannula limit (displays to indicate the upper flow rate limit for the cannula selected) 6. When adjustments are completed, tap the [Confirm] button at the bottom of the screen. Page 40 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 41: Stop Therapy

    When you tap the [Stop therapy] button, a Confirmation pop-up screen displays: Figure 41: [Stop therapy] Confirmation pop-up screen Discontinue Therapy When a patient is ready to discontinue use of the HVT 2.0 device, follow the instructions below to stop therapy: 1. Remove the cannula from the patient.

  • Page 42: Shut Down

    Intra-Hospital Patient Transfer NOTE: This section is only applicable if the HVT 2.0 device is equipped with the HVT 2.0 Transfer Upgrade Kit. The HVT 2.0 system with the transfer upgrade supports the transfer of patients and patient ambulation within the hospital environment, including from the Emergency Department to inpatient care areas, to and from tests and procedures (non-MRI), and to rehabilitation activities.

  • Page 43: How To Transfer A Patient

    3. Disconnect the wall oxygen hose. 4. Unplug the HVT 2.0 device from the wall outlet. (Note: Keep the power cord with the device.) The device will now run on the transfer battery without interruption to deliver therapy.

  • Page 44: Section 5: Alarms & Advisories, Hospital/Clinician Use

    46 for more details. HVT 2.0 employs two levels of alarms, depending on the urgency of the alarm. Medium Priority Alarms: The alarm tone is a series of three beeps, repeated every 5 seconds. Medium priority alarms take priority over and are sounded at a higher volume than all low priority alarms.

  • Page 45: What To Do If An Alarm Or Alert Occurs

    The device must be repaired by trained service personnel. NOTE on Operator’s Position: The alarm priorities have been designed for an operator positioned within 3 meters of the device. HVT 2.0 Instructions for Use 43000655 Rev C Page 45...

  • Page 46: Alarm System Functionality Verification

    NOTE: All alarms can be found on the “Event Log”. Figure 44: Sample of alarm displaying on the screen Page 46 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 47: Multiple Alarms - Medium Priority And Low Priority

    For serious situations, such Figure 47: Sample of caution with [More information] button as Water out, tap the [More information] button for actions to take to rectify the problem. HVT 2.0 Instructions for Use 43000655 Rev C Page 47...
  • Page 48 Description and Actions Required Low Flow Detected flow does not match user setting. Check cannula selection. If the alarm re-occurs, call your Vapotherm service provider for help. High Flow Detected flow does not match user setting. If the alarm re-occurs, call your Vapotherm service provider for help.
  • Page 49 To continue therapy, re-insert circuit. Error - Detected FiO does not match user setting. Therapy Stopped If the alarm re-occurs, call your Vapotherm service provider for help. Safety Battery Safety battery failed or not installed. Failure Call your Vapotherm service provider for help.
  • Page 50 High System Check that the vents on the back and the bottom of the device are Temperature not obstructed. If the error persists, call your Vapotherm service provider for help. Table: Information Advisories Message Description and Actions Required Water Low Water running low.

  • Page 51: Water Level Sensing

    Water Level Sensing The HVT 2.0 device is equipped with water level sensing to notify clinicians of the water level and indicate when water must be added. It provides notifications in the following intervals: Alarm Notification Water Level First Alarm: Water supply running low.
  • Page 52 This page intentionally left blank. Page 52 HVT 2.0 Instructions for Use 43000655 Rev C...

  • Page 53: Section 6: Training

    Vapotherm website. Section 7: Maintenance & Disinfection All HVT 2.0 Disposables (patient circuits, cannulas, and accessories) are validated for single patient use for up to 30 days. Preventive Maintenance The table below outlines the anticipated schedule of routine maintenance.

  • Page 54: Inspect The Power Supply Cord

    6 months or as recommended per your institution’s policy. To replace, insert the patient air intake filter into the back of the HVT 2.0 device. Figure 48: Insert patient air intake filter in back of device Replace the Internal Safety Battery Caution: HVT 2.0 will not operate without the internal safety battery in place.

  • Page 55: Cleaning & Disinfection

    Outside the U.S., follow national or international regulations. NOTE: The HVT 2.0 device should be cleaned according to the above instruction after each patient. HVT 2.0 Instructions for Use 43000655 Rev C Page 55...

  • Page 56: Disposal Instructions

    Disposal Instructions HVT 2.0 Device Disposal The HVT 2.0 device contains electronics. Do not discard with regular waste. Instead, return the device to Vapotherm or dispose of it according to local guidelines for disposing of electronics. For the European Union, dispose of the device according to the Waste Electrical and Electronic Equipment (WEEE) directive.

Table of Contents

Save PDF