Vapotherm Precision Flow Hi-vni User Manual

Precision Flow® Hi-VNI

Instructions for Use

Table of Contents

Symbols 3

Section 1 Indications, Warnings and Cautions 4

Section 2 Overview 7

Section 3 Principles of operation 8

Section 4 Controls, displays & connections 10

Section 5 Modes of operation 13

Section 6 Initial assembly 14

Section 7 Setting up 15

Section 8 Adjustments 19

Section 9 Connecting to patient 20

Section 10 Operating guidelines 21

Section 11 Changing the disposable patient circuit 22

Section 12 Alarms 23

Section 13 Shut down 27

Section 14 Routine maintenance 27

Section 15 Cleaning and disinfection 28

Section 16 Specifications 29

Appendix:
Audio Tone Characteristics 32
Software modes 33
EMC Guidance 34

Page

Precision Flow® Hi-VNI Packaging contains:

Precision Flow® Hi-VNI Unit
Instructions for Use (USB)
Quick Reference Guide
Power Cord
O2 Sensor Cell
Air & Oxygen Inlet Particulate Traps with Connectors
US ONLY- Air and Oxygen Hoses
Nurse Call / EMR Communication Cable
with adapter cables (varies by country)
Quick Set Up Sticker (English speaking countries only)
Delivery Tube clip

Page 2 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B

MR Unsafe

Vapotherm Inc. has declared that this product conforms with the European
Council Directive 93/42/EEC Medical Device Directive when it is used in
accordance with the instructions provided in the Instructions For Use.

This symbol indicates that the waste of electrical and electronic equipment
must not be disposed as an unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the manufacturer for
information concerning the decommissioning of your equipment.

Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 3

Section 1 Indications, Warnings and Cautions

General Indications & Contraindications.

Primary Indications:

Precision Flow® Hi-VNI is intended for use to add warm moisture to breathing gases from an
external source for administration to a neonate/infant, pediatric and adult patients in the hospital
and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen
mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen
analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

Precision Flow® Hi-VNI provides high velocity nasal insufflation (HVNI) with simultaneous
oxygen delivery to augment breathing of spontaneously breathing patients suffering from
respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® Hi-VNI is not
intended to provide total ventilatory requirements of the patient and not for use during field

transport.

Contraindications:
General:

• 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

• The Precision Flow® Hi-VNI is not for field transport

• The Precision Flow® Hi-VNI is MRI unsafe. Do not use it in an MR environment.

Warnings and Cautions

A Warning indicates that a situation may occur which is potentially harmful to the patient or user.
A Caution indicates a condition that may lead to equipment damage, malfunction, or inaccurate
operation. A Note indicates a point of emphasis to make operation more efficient or convenient.

Please take the time to familiarize yourself with the warnings, cautions, and notes listed in
these instructions. They cover safety considerations, special requirements, and regulations.

The user of this product shall have sole responsibility for any malfunction due to operation
or maintenance performed by anyone not trained by Vapotherm staff or official training
documentation.

When handling any part of the Precision Flow® Hi-VNI, always follow hospital infection
control guidelines and Standard Precautions. Vapotherm also recommends that users follow
the Centers for Disease Control (CDC) publications: Guidelines for Maintenance of In-Use
Respiratory Therapy Equipment and Guidelines for Prevention of Nosocomial Pneumonia.

General Warnings

Federal Law (U.S.) restricts the sale of this device to, or by the order of any physician. This
device should be used ONLY by a trained respiratory therapist or certified operator. Training is
to be provided and shall be conducted by authorized Vapotherm personnel only.

This is a humidification device generally used for providing continuous flows of breathing gas.

The Precision Flow® Hi-VNI is not a ventilator and should not be used as life support.

Oxygen supports combustion; this device should not be used near or around open flames, oil, or
grease, or flammables.

Service on the device should only be performed by qualified, certified service technicians.

To prevent injury, do not attempt to do any service to the Precision Flow® Hi-VNI while a patient

Page 4 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B

Section 1 Indications, Warnings and Cautions

is connected to the device.

If the device is damaged or not working properly, do not use. Contact Vapotherm or your
authorized Vapotherm representative.

Do not operate if power cord is damaged.

No modification of the equipment is allowed. Do not modify this equipment without
authorization of Vapotherm. If this equipment is modified, appropriate inspection and testing
must be conducted to ensure continued safe use of the equipment.

The device should not be placed in run mode and left unattended in a non-care environment.
When utilized in a care environment, operator shall remain close enough to hear the alarms.

Do not use the Precision Flow® Hi-VNI at an altitude above 6,392 feet or outside a temperature
of 18-30°C. Using the Precision Flow® Hi-VNI outside of this temperature range or above this
altitude can affect the quality of the therapy or injure the patient.

Do not use the Precision Flow® Hi-VNI in or around water, other than the sterile water supply
that feeds the system.

Do not use the Precision Flow® Hi-VNI system in combination with any other system intended
for humidification of respiratory gases (e.g. heat and moisture exchangers (HMES)).

Do not add any attachments or accessories to the Precision Flow® Hi-VNI that are not
approved by Vapotherm. Unauthorized attachments or accessories may affect the quality of
the therapy.

Prior to use, the Precision Flow® Hi-VNI should be positioned and secured to a Vapotherm
approved roll stand with the base of the unit no more than 40” (102cm) above the floor to
reduce risk of tipping.

Make sure all Disposable Patient Circuit connections have been properly secured.

The vapor transfer cartridge, disposable water path and delivery tube are labeled as single
patient use only and must be replaced after 30 days use on a single patient (nasal cannula
replaced as required): do not attempt to sterilize or reuse and follow all local and federal
regulations for disposal. Outside the USA follow national or international regulations. Reuse
of any of these components may result in mechanical failure and/or increased risk of bacterial
contamination.

Failure to utilize sterile water supply or clean gas supply may increase risk of bacterial
contamination.

• Use aseptic technique.

• Gas supply must be clean dry medical grade gas to prevent harm to the patient and
prevent damage to the Precision Flow® Hi-VNI

Precision Flow® Hi-VNI is not a Continuous Positive Airway Pressure (CPAP) device.
There are no controls to deliver or monitor airway pressure. Precision Flow® Hi-VNI should not
be used to deliver pressure in a closed system.

Never connect the unit to a patient until it reaches at least 33°C. Allow the unit to warm-up to
purge condensate and prevent patient discomfort due to cold or partly humidified gas.

Patients receiving supplemental oxygen are acute and appropriate clinical vigilance should be
observed by the care team. Additional patient monitoring including pulse oximetry is necessary
if the Precision Flow® Hi-VNI is used to give supplementary oxygen.

The Precision Flow® Hi-VNI is MRI unsafe. Do not use it in an MR environment.

Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 5

Section 1 Indications, Warnings and Cautions

The unit is provided with a Hospital Grade power cord. Do not use any other cord. Do not
use extension cords. For grounding reliability, the cord must be connected to an equivalent
receptacle marked “Hospital Grade” or “Hospital Only.” If any doubt exists as to the grounding
connection, do not operate the device.

Medical electrical equipment needs special precautions regarding electromagnetic radiation.
Portable and mobile RF communications equipment can affect medical equipment and should
not be used near the Precision Flow® Hi-VNI.

The back-up battery is designed for temporary use only, when AC power to the unit has been
interrupted. The internal battery backup maintains flow and oxygen percentage for at least 15
minutes if AC power is cut off. When the Precision Flow® Hi-VNI is running on battery, there
is no heat or humidity provided with the set flow and FiO2 and humidity level may drop below
safe limits. After the battery is fully discharged the device will not operate and patient gas flow
will cease. There are no alarms or display indicators after the battery has discharged. The
battery is not intended for patient transport.

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.

General Cautions

Read and understand these instructions prior to operating the system.

Clamp sterile water supply when not in use, including Standby mode, to prevent damage by
water ingress.

Aseptic techniques (including hand washing and avoiding touching connection points) and
Standard Precautions should always be followed when handling medical equipment. Standard
Precautions should always be followed when coming into contact with patients.

Do not cover the unit; blocking the vent may damage the unit.

Do not:

• Immerse the Precision Flow® Hi-VNI in water.

• Steam or gas sterilize the Precision Flow® Hi-VNI.

• Wipe with chlorine bleach solution greater than 2% strength.

Flexible sterile water bags are recommended. If rigid or semi-rigid bottles are used, a
Vapotherm approved adapter must be used.

NOTE: Interdependence of FiO2 and Flow are directly related to input supply pressure. The
Precision Flow® Hi-VNI may be operated with limited performance at gas inlet pressures
as low as 4 psi (28 kPa); however, for the full specified range of gas flows and oxygen
percentages, both gas inlet pressures must be 40 psi (276 kPa) or above. When both or
either of the supply pressures are less than 40 psi, the Precision Flow® Hi-VNI calculates the
maximum achievable flow and/or titration and limits the user adjustable parameters on the
user interface.

The maximum limited pressure and maximum operating pressure of the Precision Flow® Hi­VNI is 20 psi (138 kPa).

Precision Flow® Hi-VNI is not for field transport. When used with approved ancillary
equipment, the Precision Flow® Hi-VNI may be used for transferring patients within the
hospital.

Page 6 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B

Section 2 Overview

The Precision Flow® Hi-VNI is a system for high flow humidified respiratory therapy by a
Vapotherm approved interface. It incorporates the Vapotherm core humidification technology
with an electronic blender and flow controller. The water and gas pathways are both
incorporated into a removable, disposable patient circuit.

Features

• EMR and nurse call connectivity capable for indicating
an alarm condition on a hospital nurse call system
and interfacing Electronic Medical Record capable
technologies.

• The patient circuit is detachable and disposable: no
disinfection necessary

• Minimal downtime between patients: less than five
minutes to change disposables

• Built-in oxygen/air blender

• Built-in electronic flowmeters and controllers

• Self-testing and self-calibrating

• Internal battery backup maintains flow and oxygen
percentage for at least 15 minutes if AC power is cut
off. Battery recharges in 2 hrs.

• All internal sensors are self-calibrating and self­monitoring

• Single button starts and stops the device

• Temperature, flow and oxygen percentage are
adjusted via a single setting control knob on the front panel

• All values and alarms displayed in a single large color-coded panel

• Flow range 1-40 L/min

• Oxygen percentage is fully adjustable from 21 to 100% when two 40 psi (276 kPa) gas
sources are used

• Inlet gas pressure range is 4-85 psi (28-586 kPa)

• Single gas operation: the Precision Flow® Hi-VNI detects inlet gas pressure and blends flow
based on demand required and available supply. Supply pressure determines FiO2 and
delivered flow; if demand exceeds supply an alarm sounds

• At low gas inlet pressures, maximum flow rate and oxygen percentage settings are
automatically reduced to match the inlet pressure

• Automatically senses cartridge type: maximum flow setting is automatically reduced if low­flow cartridge is installed

• Warm-up time less than five minutes

• Sterile water supply is connected to the disposable water path using a standard spike

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

• Scheduled maintenance: gas inlet filters replaced at 6-month intervals, oxygen sensor
replaced annually, battery replaced every two years

Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 7

Precision Flow® Hi-VNI

Section 3 Principles of operation

The Precision Flow® Hi-VNI warms and humidifies breathing gas for delivery by a Vapotherm
approved interface at flows from 1 to 40 L/min. The unit incorporates an electronic blender and flow
sensors that allow the oxygen percentage and total gas flow to be set independently.
The Precision Flow® Hi-VNI consists of two parts:

Main unit

• The capital unit which contains all the electrical and electronic components including the
electronic blender and flow controllers, and remote sensors to monitor the disposable water
path. The main unit 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 are 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 lines. An oxygen sensor monitors the gas mixture and signals
any discrepancy between target and measured percentage. The oxygen sensor is automatically
calibrated with oxygen at power-up and every 24 hours.

• Firmware running in the main unit uses sensors to monitor gas pressure, water temperature,
and to detect air leaks into the water pathway of the disposable patient circuit (bubble detector).
Alarms are displayed if any parameters are outside the normal range. Other indicators show low
charge in the backup battery, and the type of cartridge installed. See Appendix for a description
of the firmware states and transitions.

• After a two hour charging period, an internal battery backup will maintain the set flow and oxygen
blend for at least 15 minutes without AC power.

WARNING: The back-up battery is designed for temporary use only, when AC power to the
unit has been interrupted. When the Precision Flow® Hi-VNI is running on battery, there is no
heat or humidity provided with the set flow and FiO2 and humidity level may drop below safe limits.

After the battery is fully discharged the device will not operate and patient gas flow will cease.
When fully charged, the battery provides at least 15 minutes of power. The battery is not
intended for patient transport.

Disposable patient circuit

• The disposable patient circuit (DPC) is comprised
of the disposable water path (DWP), vapor transfer
cartridge (VTC) and delivery tube. Conditions in the
circulating water and gas streams are sensed remotely
via the interface between the main unit and the
disposable water path.

• Vapor transfer cartridge. In the cartridge, blended
gas passes through the lumens of hundreds of parallel
hollow fibers made of a specially developed polymer.
Warm water circulates around the fibers and diffuses
as vapor through the fiber material into the gas stream
flowing through each fiber. Unlike most humidifiers,
there is no direct contact between the water and
gas streams. The gas stream leaves the cartridge
saturated with vapor at the set temperature.

Note: Use only approved cartridges from Vapotherm Inc.

Page 8 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B

Air Inlet

Water Inlet

Water Outlet

Air Outlet

Section 3 Principles of operation

• Patient delivery tube. The warmed humidified gas

passes through the center of a triple-lumen heated
delivery tube. The center lumen is surrounded by two
outer lumens circulating warmed water to maintain
the temperature of the inner lumen and to minimize
rain- out. A proprietary short nasal cannula is
connected to the end of the delivery tube and passes
the humidified breathing gas to the patient’s nares. It
is normal for non-DEHP PVC tubing to appear slightly
cloudy, or yellow, especially during longer use or
when operated at higher temperatures.

• Disposable water path. The disposable water path
houses a water reservoir, pump, connections for
the vapor transfer cartridge and delivery tube, and
sensor interfaces to the main unit. Water is pumped
past a heater plate through the outer lumens of the
delivery tube. Returning water passes through the
outer jacket of the specially designed vapor transfer
cartridge where some water is lost as vapor to the
gas stream. There is no direct contact between water
and gas flows. The water then returns to the pump
reservoir. Heater power automatically maintains
the set temperature. Water flows into the circuit
from the sterile water supply to replace evaporative
losses in the vapor transfer cartridge. Air is purged
to atmosphere from the circulation via a hydrophobic
filter membrane.

Electronic Medical Record (EMR) System Integration

Warm Wa ter

Flow

Cross-secti on of Tubing

Breathing

Gas

Warm Wa ter

Ret urn

The Precision Flow® Hi-VNI provides outbound interface capabilities that facilitate integration
with Electronic Medical Record (EMR) Systems. The Precision Flow® Hi-VNI does not connect
directly to EMR Systems. Interface of the Precision Flow® Hi-VNI to EMR systems requires the
services and technology of an EMR Integrator. The EMR Integrator provides integration into
the institution’s physical network with interface hardware (wired or wireless device adapters)
and a communication translation engine (Gateway) to translate the Precision Flow® Hi-VNI’s
data output to specific EMR system formats, then validate the functionality of the connection.
Bernoulli Systems (formally Nuvon) and Capsule are the Vapotherm recommended 3rd party
integrators.

See Section 5 for a description of the modes of operation.

Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 9

Section 4 Controls, displays, & connections

16

15

13

12

11

1

2
14

3

4

10

9

8

1. Battery low or charging

2. Disposable water path faulty or absent

3. Vapor transfer cartridge type

4. Vapor transfer cartridge fault

5. Gas supply fault

6. Run/Stop Status LED

7. Run/Standby button (see note)

8. Setting control knob

9. Alarm mute button

10. Alarm muted LED

11. General fault

12. Water out

13. Blocked tube

14. Temperature Display

15. Flow Display

16. Oxygen % Display

5

6

7

Note:The Precision Flow® Hi-VNI has no ON/OFF switch. Plug the unit into a wall outlet to

keep the battery fully charged.

Page 10 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B

Section 4 Controls, displays, & connections

Front view

1

2

3

4

5. Hinged door:

• Opens to install or remove disposable

water path

6. Status light:

• Amber flashing in Sleep mode

• Amber solid in Standby mode

• Flashing green in Run mode when output

does not match settings
(e.g. during warmup)

• Steady green in Run mode when unit is

operating normally

7. Run/standby button:

• Press to start unit after water, DPC,

and gas are connected

1. Folding carrying handle

2. Multi-function display:

• Shows set values for oxygen %, flow
and temperature

• Icons indicate alarm conditions and
device status

3. Alarm mute:

• Press to silence alarms for up to
2 minutes

• LED indicates one or more alarms
are muted

4. Setting control knob:

• Press to select which variable to adjust

• Rotate to adjust to parameter value

• Press again to set value

5

6

7

Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 11