Vapotherm Precision Flow Plus User Manual

Precision Flow® Plus

Instructions for Use

Table of Contents

DRAFT

Symbols 3

Section 1 Indications, Warnings and Cautions 4

Section 2 Overview 6

Section 3 Principles of operation 7

Section 4 Controls, displays & connections 8

Section 5 Modes of operation 11

Section 6 Initial assembly 12

Section 7 Setting up 13

Section 8 Adjustments 17

Section 9 Connecting to patient 18

Section 10 Operating guidelines 19

Section 11 Changing the disposable patient circuit 20

Section 12 Alarms 21

Section 13 Shut down 24

Section 14 Routine maintenance 24

Section 15 Cleaning and disinfection 25

Section 16 Specifications 26

Appendix:

Audio Tone Characteristics 28
Software modes 29
EMC Guidance 30

Page

Precision Flow® Plus Packaging contains:

Precision Flow® Plus 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
Quick Set Up Sticker (English speaking countries only)
Delivery Tube clip

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Symbols

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.

Some Vapotherm accessories contain DEHP [Di-(2-Ethylhexyl) Phthalate] which
is the most frequently used plasticizer to add flexibility to medical tubing. The
medical tubing is intended for the transport of medical breathing gases and not for
the storage of substances that have chemical extraction properties. The European
Commission has issued the following statement:

“The Scientific Committee on Emerging and Newly Identified Health Risks
(SCENIHR) has evaluated the exposure to DEHP for the general population and
patients during medical procedures. In some cases the exposure is significant and
exceeds the toxic doses observed in animal studies. There is a reason for some
concern for prematurely born male neonates for which the DEHP exposure may
be transiently above the dose inducing reproductive toxicity in animal studies. So
far, there is no conclusive scientific evidence that DEHP exposure via medical
treatments has harmful effects in humans. But, it is recognized that especially
the potentially high exposure during medical treatments may raise a concern,
even in the absence of clinical or epidemiological evidence, for harmful effects in
humans.” – SCENIHR 2008

Pregnant and nursing women should consider the effects on a child that may
occur from medical respiratory treatments. The general population is exposed
to phthalates daily from dietary sources and the inhalation of air. The extent of
medical treatment exposure largely depends upon the medical treatments given
and the duration of the treatment.

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Section 1 Indications, Warnings and Cautions

DRAFT

General Indications & Contraindications.

Primary Indications:

Precision Flow® Plus 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,
subacute institutions, and home 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.

Contraindications:
General:

Precision Flow
Specific to Nasal Cannula:

Patients with occluded or defective nares should not use the system.

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
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.

®

Plus: None Known

®

Plus, always follow hospital infection control

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 operator.

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

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

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.
The device should not be turned on and left unattended if not on a patient.
Do not use the Precision Flow

the system.
Do not use the Precision Flow

humidification of respiratory gases (e.g. heat and moisture exchangers (HMES))
Prior to use, the Precision Flow

roll stand with the base of the unit no more than 40” (102cm) above the floor to reduce risk of tipping.

Page 4 3100954 Rev. A

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Plus is not a ventilator and should not be used as life support.

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Plus while a patient is

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Plus in or around water, other than the sterile water supply that feeds

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Plus system in combination with any other system intended for

®

Plus should be positioned and secured to a Vapotherm approved

Section 1 Indications, Warnings and Cautions

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: do not attempt to sterilize or
reuse and follow all local and federal regulations for disposal. Outside the USA follow national or
international regulations.

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® Plus

®

Precision Flow
no controls to deliver or monitor airway pressure. Precision Flow® Plus should not be used to deliver
pressure in a closed system.
Never connect the unit to a patient until it reaches set point temperature (temperature display stops
flashing). Allow the unit to warm-up to purge condensate and prevent patient discomfort due to cold
or partly humidified gas.

Additional patient monitoring is necessary if the Precision Flow

The Precision Flow

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

The back-up battery is designed for temporary use only, when AC power to the unit has been
interrupted. 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.

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® Plus in water.

• Steam or gas sterilize the Precision Flow® Plus.

• Wipe with bleach.

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

NOTE: The Precision Flow
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. Precision Flow® Plus
has not been tested for use in field transport. When used with approved ancillary equipment, the
Precision Flow® Plus may be used for transferring patients within the hosiptal.

3100954 Rev. A Page 5

Plus is not a Continuous Positive Airway Pressure (CPAP) device. There are

®

Plus is used to give supplementary oxygen.

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Plus is not MRI compatible.

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Plus

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Plus may be operated with limited performance at gas inlet

Section 2 Overview

DRAFT

The Precision Flow® Plus 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

• 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
self monitoring

• 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 lpm

• 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® Plus detects inlet gas pressure and blends
flow based on demand required and available supply. Supply pressure determines FiO
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
low-flow 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® Plus

2

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Section 3 Principles of operation

The Precision Flow® Plus warms and humidifies breathing gas for delivery by a Vapotherm approved
interface at flows from 1 to 40 lpm. 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

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 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. 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.

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.

• 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.

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

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Plus consists of two parts:

Section 4 Controls, displays, & connections

DRAFT

13

12

11

1

2

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

Note:The Precision Flow® Plus has no ON/OFF switch. Plug the unit into a wall outlet to
keep the battery fully charged

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

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Section 4 Controls, displays, & connections

Front view

1

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

2. Multi-function display:

• Shows set values for oxygen %, flow
and temperature

3

• 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:

4

• Press to select which variable to adjust

• Rotate to adjust to parameter value

• Press again to set value

5

6

7

3100954 Rev. A Page 9

Section 4 Controls, displays, & connections

DRAFT

1

2

3

5

6

7

4

Rear view

1. Hinged door

• Open to install or remove disposable water path

2. Vent

3. Access panel for O2 sensor with nurse call/EMR connector (see note)

4. Pole clamp

5. Power cord connection and fuse holder

6. DISS or NIST oxygen connection

7. DISS or NIST air connection

8. Gas inlet filters and traps

Note: Using a permanent marker, write an expiration date on the O
sensor cell that is one year from the date it is removed from its packaging.

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(subscript)

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