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
Page 2 3100954 Rev. A
Page 3
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.
3100954 Rev. A Page 3
Page 4
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
®
Plus is not a ventilator and should not be used as life support.
®
Plus while a patient is
®
Plus in or around water, other than the sterile water supply that feeds
®
Plus system in combination with any other system intended for
®
Plus should be positioned and secured to a Vapotherm approved
Page 5
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.
®
Plus is not MRI compatible.
®
Plus
®
Plus may be operated with limited performance at gas inlet
Page 6
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
Page 6 3100954 Rev. A
Page 7
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.
3100954 Rev. A Page 7
®
Plus consists of two parts:
Page 8
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
Page 8 3100954 Rev. A
Page 9
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
Page 10
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.
Page 10 3100954 Rev. A
8
(subscript)
2
Page 11
Section 4 Controls, displays, & connections
Docking station for disposable water path
WARNING:
Heater plate may
be hot!
Arrows show locations of optical sensor ports.
Do not scratch or scrub the ports.
Do not apply organic solvents or bleach.
Section 5 Modes of operation
ModeActionIndicator light color
SleepDisplay in sleep mode, no gas flowAmber
StandbyDisplay flashes 00; parameters can be adjusted, no gas flowAmber
RunWarming to set point temperature, gas flow
Unit operating at set point, gas flow
See Appendix for a description of the software operating modes.
3100954 Rev. A Page 11
Flashing green
Solid green
Page 12
Section 6 Initial assembly
DRAFT
Certain accessories must be installed in the Precision Flow® Plus unit before it can be used.
These will normally be supplied in a separate package from the main unit as some are countryspecific.The power cord plugs into the IEC60320-compliant receptacle on the rear panel.
6a. Oxygen sensor installation
CAUTION: The oxygen sensor is in a sealed
package. Un-sealing the package admits oxygen
to the sensor, which should be replaced after 1
year. Do not open the package until the unit is to
be used. Write the expiration date on the oxygen
sensor cell.
1. Loosen three (3) captive screws from the access
panel. Pull the panel away from the unit.
2. Insert the threaded end of oxygen sensor into port,
and screw into place. Sensor should be hand-tight only.
Do not use tools.
3. Plug sensor cable into connector. Replace cover.
When replacing cover, be certain not to pinch cables.
Do not over-tighten screws.
6b. Inlet gas filter trap assemblies.
Gas inlet filters and traps are supplied in a separate box with the O
installed before first-time use. The inlet filter and trap assemblies have a quick-disconnect
fitting which connects to the main unit, and a gas fitting for either an oxygen or an air hose.
Note: The quick-disconnect tubes for the oxygen and air filters are different sizes, so that they
can not be connected incorrectly.
Oxygen Sensor Access Panel
sensor and must be
2
WARNING: Never attempt to run the Precision Flow® Plus unit without the gas inlet filters.
Particles in the inlet gas flow will cause irreparable damage to the mass flow sensors.
Installing the gas inlet filters
1. Push the filter assembly firmly into the correct connector opening until it is fully engaged
and it clicks. The filter can rotate but not pull out. Filter bowls should be vertical (glass
side down) when in use.
Removing gas inlet filter assembly from main unit
Note: It is not normally necessary to remove the inlet filter and trap assemblies (unless
performing preventative maintenance), but shipping and packing are easier if the filters are
detached first.
1. Press the filter assembly into the main unit.
2. Hold the locking ring in place and push it back against the main unit backplate.
3. Pull the filter assembly straight out.
Page 12 3100954 Rev. A
Page 13
Section 7 Setting up
7-1. Connect power cord if it is not already in place.
7-2. Hang the sterile water supply from hook on
Vapotherm approved roll stand.
7-3. Attach the unit to Vapotherm approved roll stand
below lowest point of the sterile water supply.
NOTE: The Precision Flow® Plus oxygen and air supply
inlet fittings are gas-specific to ensure correct connection.
WARNING: Unit weighs 10.6 lb.(4.81kg) To prevent
possible injury or damage from falling, it must be
securely fixed to a Vapotherm approved roll stand,
with the base of the unit not more than 40” (102cm)
above the floor. Fixed rail supports may also be used.
Use with Vapotherm approved roll stands.
7-4. Connect oxygen and air supply hoses to correct
inlets, then connect them to the wall outlets.
7-5. Open the bags containing the disposable water path,
vapor transfer cartridge, and delivery tube, and
assemble them as follows:
7-5-1. Remove the rubber plugs from the vapor transfer cartridge.
Install a high or low-flow vapor transfer cartridge in disposable waterpath as shown.
The vapor transfer cartridge may be inserted either way up. Align the vapor transfer
cartridge ports with the disposable water path openings and press firmly into place.
Pole
clamp
Power
cord
Oxygen
A High Flow Vapor Transfer Cartridge is shown below. It is indicated with a
REF: PF-VTC-HIGH and blue caps. High Flow Cartridges are for flow rates of 5-40 LPM.
A Low Flow Vapor Transfer Cartridge is shown below. It is indicated with a
REF: PF-VTC-LOW, red caps and the addition of two black stripes. Low Flow
Cartridges are for flow rates of 1-8 LPM.
3100954 Rev. A Page 13
Page 14
Section 7 Setting up
DRAFT
7-5-2. Connect the delivery tube to the disposable water path as shown.
Press firmly into place.
7-6. Inserting disposable patient circuit:
7-6-1. Open door to expose the docking station.
7-6-2. Hold disposable patient circuit by its handle,
with the delivery tube downward as shown.
7-6-3. Slide disposable patient circuit downward into
the docking station until it stops.
7-6-4. Press down firmly so there is no gap between the
bottom of the Disposable Water Path and the docking
station floor.
7-6-5. Close door.
NOTE: If the door does not close easily, check that the cartridge is installed correctly
and the disposable water path is fully inserted into the docking station.
CAUTION: Do not remove the disposable patient circuit while the unit is operating
Page 14 3100954 Rev. A
Page 15
Section 7 Setting up
7-6-6. General Guidelines
After connecting to the sterile water supply and unclamping the water inlet tube make sure
water is flowing into the disposable patient circuit (DPC). Wait approximately 90 seconds (or
180 seconds if using a hard water bottle) before pressing the Run/Standby button. Uncoil and
straighten the delivery tube to allow water to more easily flow into the DPC. If air pockets are
observed, gently tap the delivery tube to remove the air. Insufficient water flow may lead to a
temperature out of range alarm. Holding the distal end of the delivery tube below the Precision
®
Flow
Plus unit may fur ther assist with water f low into the DPC.
After pressing the Run/Standby button, confirm that water is properly circulating through the
machine by making sure the patient delivery tube is warm across the entire length. If good
circulation cannot be confirmed, check that the water flow is not obstructed by air bubbles in
the water inlet tube connected to the water supply, or in the patient delivery tube. Gently tap
and wiggle the tubing, or lift it up and down in order to remove any air seen in the lines.
Reference Section 12 of the Precision Flow
alarms. Additional alarm information:
If a medium priority Water Out Alarm occurs, this may be due to the sterile water supply
being empt y, an obstructed inlet tube, or accumulation of air within the DPC. Press Run/
Standby button to place the unit in Standby and disconnect patient. If the sterile water supply
is empty, replace sterile water supply. If the inlet tube is obstructed, straighten the inlet tube. If
necessary, remove and reseat the DPC to ensure that the DPC is fully seated in the Precision
®
Flow
Plus unit. Press Run/Standby button to restart the unit.
The DPC may be used up to 30 days. Circuit life may be less than 30 days, especially when
running at higher flow rates and temperatures which may reduce the useful life of the Vapor
Transfer Cartridge. This typically results in the sterile water bag filling up with air and/or a
cartridge fault alarm occurring due to gas bubbles in the water path.
After addressing any alarm condition, especially those involving an obstruction of the gas or
water flow, check all connections for leaks and make sure the Vapor Transfer Cartridge ( VTC)
is fully seated into the DPC.
®
Plus Instruction For Use for information regarding
3100954 Rev. A Page 15
Page 16
Section 7 Setting up
DRAFT
WARNING: Use high–flow cartridge for flows 5-40 lpm and low-flow cartridge for flows 1-8 lpm.
7-7. Plug in power cord, and check that all the display indicators light up. The Precision Flow
Plus performs a self-test:
• all icons and numeric displays light up for a few seconds
• internal sensors and control systems are checked
• if no faults are detected the unit enters STANDBY mode
• “Water Out” icon indicates there is no water in the disposable water path
• status LED is amber (solid)
7-8. The Precision Flow® Plus unit has three controls.
Run/Standby Button – Places the unit into run or standby mode.
Setting Control Knob - Allows you to adjust the parameters.
Alarm Mute Button – Will intermittently silence alarms
and also dims the display panel.
The Precision Flow® Plus has three modes. Those are
Sleep, Standby, and Run. In Sleep mode, the unit will
have a blank screen and a flashing amber light showing.
The unit cannot be started from sleep. (Note: If the
unit is in Standby mode and there is no user interaction
with the unit for 5 minutes, the unit automatically enters
Sleep mode).
To put the unit in Standby (from Sleep mode), simply
rotate the blue Control Setting Knob to illuminate the
display. You will see the three parameters of Flow,
percent oxygen, and Temperature. There will also
be a corresponding vapor transfer cartridge indicator
on the lower right hand side which will identify what
type of disposable patient circuit is in place
(Blue/High or Red/Low).
To enter Run Mode (from Standby mode), with the screen illuminated,
simply press and release the Run/Standby Button.
The machine will give a series of 10 beeps, and begin to power up. At this point the
small light above the Run/Standby Button will change from Amber to flashing Green.
During this start up, you will also see two amber alarm indicators illuminated.
This is normal and is part of the Precision Flow® Plus start up self test.
7-9. Push or rotate the control setting knob in either direction to light up the display in
STANDBY mode.
7-10. Press the Mute button to change between bright and dim display
(this function is only available if no alarms are active).
7-11. To connect the sterile water supply, remove spike cap and wipe spike with 70-90%
isopropyl alcohol. Firmly insert spike into spike port of the sterile water supply,
avoiding direct hand contact. Unclamp the water inlet tube so that water (>200 ml)
flows into the disposable water path and the “Water Out” alarm icon clears.
(*Wait approximately 90 seconds (or 180 seconds if using a hard water bottle)
before pressing the Run/Standby button)
Page 16 3100954 Rev. A
Run/Standby
button
®
Page 17
Section 7 Setting up
7-12. Press Run/Standby button to start gas flow, pump and heater.
Press twice if the display is initially blank (once to wake the unit up, and again
to put the unit into run mode). Check that the unit beeps while it tests the disposable
water path and pump (see Notes below).
7-13. If all tests are passed the unit enters RUN mode. Water circulates and fills the delivery
tube. The three numeric displays for flow, temperature and oxygen % display initial
factory settings or the last settings used. The Status LED flashes then shows
continuously green when the unit reaches desired temperature.
NOTES on startup:
• When the Run/Standby button is pressed, the unit enters a detection mode. A prompt
sounds and the disposable water path icon flashes for approximately five seconds.
In this mode the unit inspects the disposable water path to confirm that: a vapor
transfer cartridge is present; the disposable water path is present; and the water level
is correct. Power is then applied to the water pump. After five seconds the unit checks
that the water pump has started and is running at the correct speed.
• If the “water out” icon is displayed and accompanied by an alarm, place unit in Standby
and allow DPC to fully prime. Press Run/Standby button.
• Purging of air bubbles from the circulation cannot be seen, because the gas escapes
through a membrane at the top of the DWP, not into the water container.
• Clamp the inlet tube to stop the flow of water into disposable patient circuit
whenever the unit is in standby mode.
To adjust settings: See section 8 (Adjustments)
For alarms and troubleshooting: See section 12 (Alarms)
Section 8 Adjustments
Flow rate, oxygen %, and temperature are all adjusted
using the setting control knob in the center
of the front panel.
8-1. To enter Adjustment mode, press and release
the setting control knob. One of the three
parameters will flash to show that it is selected
for adjustment. Press the knob repeatedly to
cycle the active selection through flow rate,
oxygen %, and temperature.
8-2. To change the selected variable, rotate the
knob until the desired value is displayed.
Press the knob again to enter this value and
select the next variable.
8-3. If the knob is not rotated for five (5) seconds,
the unit returns to the normal Run mode or
Standby mode. To re-enter Adjustment mode,
press the knob again. Rotating the knob has
no effect unless one of the settings has been
selected and one of the displayed values is flashing.
3100954 Rev. A Page 17
Setting control knob
Page 18
Section 8 Adjustments
DRAFT
NOTES on settings:
• When gas inlet pressures are less than 40 psi (276 kPa) the full specified range of flows
and oxygen mixtures is not available. The Precision Flow® Plus detects the actual inlet
pressures and calculates the range of values that can be achieved. An alarm sounds if
the operator attempts to make settings outside this range.
• If oxygen is not connected, the blender setting will be fixed at 21%. If air is not connected
the setting is fixed at 100%. An audio signal sounds if the operator attempts to set any
other value.
• If a HIGH-FLOW cartridge is installed the flow can not be set below 5 lpm.
• If a LOW-FLOW cartridge is installed the flow can not be set above 8 lpm.
NOTES on adjustment:
• Transient temperature changes may occur after rapid changes in flow settings.
• During warmup the temperature display shows the actual temp of the gases being
delivered, not the set value.
• In Run mode the display shows the current set values for flow rate, oxygen %,
and temperature.
• The setting control knob is sensitive to speed. Rotate quickly for large increments and
slowly for small increments.
• If the unit is completely powered down (disconnection of AC power), than the unit will
return to default settings
Section 9 Connecting to patient
9-1. Wait for desired set temperature to be reached before placing the cannula on the end of
the patient delivery tube. The flashing green Status LED becomes steady when the set
temperature is reached.
9-2. Check water level, temperature display, gas flow rate, and oxygen percentage.
9-3. Size cannula to patient by ensuring that nasal prongs do not fit tightly into nares (1/2 the
diameter of the nares).
9-4. Attach correct sized cannula for the patient and vapor transfer cartridge onto the delivery
tube. Adjust the flow to the desired rate and fit the cannula to the patient. See appendix
table for cannula flow rates. DPC flow ranges are shown in the table below:
CartridgeCannula typeOperational flow rates
High Flow
Low Flow
*Pediatric small cannula is intended to deliver flows from 1-20 lpm
WARNINGS:
• Always follow aseptic technique (including proper hand washing and avoiding direct
hand contact with connection points) when setting up the Precision Flow® Plus and
Standard Precautions when placing on a patient.
• Cannula should not obstruct more than 50% of the nares of the patient.
• Change nasal cannulas when soiled.
Page 18 3100954 Rev. A
Adult, pediatric & small adult,
pediatric small*
Premature, solo, neonatal,
infant, intermediate infant,
pediatric small*
5-40 lpm
1-8 lpm
Page 19
Section 9 Connecting to patient
NOTES:
• The a Vapotherm approved interface should be connected to the patient only when the
unit has warmed to set temperature (temperature display stops flashing).
• 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.
• 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 tissues.
• The unit should not be placed in Standby mode for extended periods of time. For
pauses in therapy, remove cannula from the patient, set the parameters to the lowest
available setting and clamp the inlet/spike tube when not in use. To reinitiate therapy,
before the cannula is placed on patient, place the unit int RUN mode to clear
accumulated condensation.
Section 10 Operations: General Guidelines
WARNING:
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.
10-1. Check that water is properly circulating through the disposable by making sure the patient
delivery tube is warm across the entire length. If good circulation cannot be confirmed,
check that the water flow is not obstructed by air bubbles in the patient delivery tube.
10-2. Check that the patient delivery tube will not be occluded by the patient’s position or
moving bed structures.
10-3. 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.
10-4. During operation the door should be closed.
10-5. Check inlet gas traps for contaminates and press valve to empty any condensate,
if present.
10-6. Check that nothing blocks the vent on the back of the unit.
NOTE: Condensation in the cannula may occur in certain ambient conditions at flow rates
less than 5 lpm (low flow cartridge) or less than 10 lpm (high flow cartridge). To minimize
condensation it is recommended not to set the temperature higher than 34°C, if using flow
rates less than 5 lpm.
3100954 Rev. A Page 19
Page 20
Section 11 Changing the disposable patient circuit
DRAFT
The disposable patient circuit, consisting of the disposable water path, vapor transfer
cartridge and delivery tube, is marked for single patient use. They may be used for up
to 30 days on a single patient but must then be replaced.
11-1. Stop the unit by pressing the Run/Standby button.
11-2. Clamp the water inlet tube connected to the sterile water supply.
11-3. Open the door to expose the disposable water path.
11-4. Lift the disposable patient circuit out of the Precision Flow® Plus unit and discard in
accordance with institutional guidelines.
11-5. Wipe down the docking station with 70-90% isopropyl alcohol wipes or other Vapotherm
approved cleaning agents.
NOTE: If the door does not close easily, check that the cartridge is installed correctly
and the disposable water path is fully inserted into the docking station.
WARNINGS:
• The heater plates on the docking station and
disposable water path may be hot !
• Universal precautions and aseptic technique must be used in
handling the disposable parts.
11-6. Open a new vapor transfer cartridge, delivery tube and disposable water path.
11-7. Install the vapor transfer cartridge in the disposable water path as described in Section 7
(Setting up).
CAUTIONS:
• The sensor windows in the docking station must not be scratched or damaged. If
necessary, wipe down the docking station with 70-90% isopropyl alcohol wipes or
other Vapotherm approved cleaning agents. Never use sharp instruments or
abrasive cleaners to clean windows.
11-8. Slide the disposable patient circuit into the docking station and close the door.
11-9. Hang new sterile water supply on the hook of the Vapotherm approved roll stand.
11-10. Wipe the spike on the water inlet tube with 70-90% isopropyl alcohol and insert into
spike port of the sterile water supply.
11-11. Re-start the unit.
Page 20 3100954 Rev. A
Page 21
Section 12 Alarms
Fault conditions are indicated by icons displayed on the front panel and by audio signals.
• Unless indicated otherwise, alarms will self-clear when the fault condition is corrected.
• The MUTE button will silence low priority alarms for 2 minutes and medium priority alarms
for 20 seconds (except for Blocked Tube alarm, which can only be muted for 5 seconds or
less while the alarm resets). General fault alarms cannot be muted.
• Gas flow continues during alarm conditions -except when the O2 supply gas pressure is
outside specified range.
• An amber LED above the Mute button indicates that one or more alarms are muted.
FLOW display in liters/min OXYGEN % display
Battery low or
charging (not
indicative of
charge level)
Disposable
water path faulty
or absent
Low flow Vapor
transfer cartridge
Blocked
tube
Water
out
General
fault
TEMPERATURE display
installed
Vapor transfer
cartridge fault (low
flow or high flow)
High flow Vapor
transfer cartridge
installed
Gas supply fault
ALARM TONE PRIORITIES
• MEDIUM PRIORITY alarms require immediate attention and are indicated by rapid
intermittent tones (fast triple beeps).
• LOW PRIORITY alarms require attention as soon as reasonably possible and are
indicated by infrequent intermittent tones (slow double beeps).
In addition to the medium and low alarms, the Precision Flow® Plus emits the following
audio signals:
• single dull tone that sounds when the unit switches from run to standby mode
• single high pitched beep whenever you press the control setting knob
• low pitched buzz when you try to change a setting that cannot be changed or when alarm
conditions prevent entering the run mode
• slowly repeating single beep during disposable water path testing
3100954 Rev. A Page 21
Page 22
Section 12 Alarms
DRAFT
Alarm Table
Alarm iconAudio SignalIndicatesCauseAction
General fault
and " - - " in
flow
(flashing)
Medium
Priority
Cannot be
muted
Malfunction of
sensor or control system
Internal component failure
Cannot be corrected
by user: disconnect
patient. Shut off unit,
send for service.
General fault
and " - - " in
(flashing)
O
2
Blocked tube
(flashing)
Water outMedium
Disposable
water path
(flashing)
Battery
charging
(steady)
Battery
(flashing)
Medium
Priority
Cannot be
muted
Medium
Priority
Mutes only
during brief
reset period
Priority
Medium
Priority
NoneThe internal battery backup is not fully charged. The
Medium
Priority
O2 sensor
fault
High back
pressure
No water in
disposable
water path.
Gas flow
continues
without heating or water
circulation.
Disposable
water path
faulty or not
detected. Unit
will not run.
unit would not run on battery for the full rated time in the
event of a power failure. No action is necessary.
The unit is
running in
BATTERY
mode. Gas
flow and
blending continue without
heat or water
circulation.
Depleted or
defective O2
sensor
Obstructed or
kinked cannula/
delivery tube,
incorrect cannula for flow
rate, or DPC
improperly
seated
Sterile water
empty, or
obstructed inlet
tube.
Disposable water path
defective, not
properly seated
or not installed.
AC power is
disconnected
Reset by shutting
off unit. Replace O2
sensor. Restart unit
Gas supply (flashing)
Gas supply
(continuous and flow
rate numeric display
flashes)
General Fault
and " - - " in
temperature
(flashing)
Temperature numeric
display flashes
GENERAL FAULT ALARMS: Failures in the control or measurement systems will cause a General Fault
alarm indicated by this icon accompanied by the Temp display showing numbers between 50 & 84 (error codes)
and dashes in the O2 and Flow displays. When an error code is displayed, gas delivery is stopped. The user
needs to monitor the treatment and respond to general fault alarms. General Fault alarms cannot be silenced
with the mute button. To reset, first disconnect the unit from AC power and then press the Run/Standby button.
With the exception of O2 sensor replacement, the unit must be repaired by an approved service facility.
3100954 Rev. A Page 23
Medium
Priority
Medium
Priority
Medium
Priority
Cannot be
muted
NoneTemperature 2°
Gas supply
pressure
outside 4-85 psi
(28-586 kPa)
range. Unit will
not operate.
Selected flow
can not be
provided from
current gas
supply.
Temperature
out of range.
> set point
Temperature 2°
< set point
Gas supply is
disconnected
or exhausted.
Inlet gas pressure too low
for selected
flow rate.
Overheating
or temperature sensor
malfunction.
User enters
set point
much lower
than previous
temperature.
Very low water
temperature
after bag
replacement.
Check gas supply and correct as necessary.
Increase gas pressure or
decrease flow setting.
Cannot be corrected by
user: disconnect patient.
Shut off unit and send for
service.
Silence alarm and wait for
temperature to drop.
Silence alarm and wait for
temperature to rise.
Page 24
Section 13 Shut down
DRAFT
13-1. Stop the unit by pressing the Run/Standby button and hold for 2 seconds. Unit will enter
Standby mode.
13-2. Clamp the water inlet tube.
13-3. Open the hinged door, remove the disposable water path with vapor transfer cartridge
and delivery tube attached by sliding it upwards out of the docking station.
13-4. Discard all disposables according to hospital guidelines.
13-5. Disconnect unit from AC power.
Note: The Precision Flow® Plus has no ON/OFF switch. Plug the unit into a wall socket to
keep the battery fully charged.
CAUTION: Even a fully charged battery will lose its charge over a period of weeks
when the unit is not connected to an AC source. It is recommended that the unit is
connected to AC for at least two hours once a month to maintain battery charge.
Section 14 Routine maintenance
14.a The internal backup battery should be replaced every two years. Contact Vapotherm for
further information.
14.b Oxygen sensor
The oxygen sensor (part no. 3003011) should be replaced annually. It is accessible by
removing a panel at the back of the unit, and can be changed in a few minutes by the user or
biomedical engineer. Use only Vapotherm approved parts.
To replace oxygen sensor:
1. Loosen three (3) captive screws from the access panel.
Pull the panel away from the unit.
2. Disconnect the cable connector: grasp with pliers and
pull straight back.
3. Unscrew the sensor body from its housing. Insert new
sensor and screw in.
4. Plug in cable and replace cover. When replacing cover,
be certain not to pinch cables. Do not over-tighten
screws.
5. Apply label to indicate when replacement is due or write
the date with a permanent marker.
CAUTION: Sensor should be hand-tight only. Do not use tools.
Oxygen sensor access panel
Page 24 3100954 Rev. A
Page 25
Section 14 Routine maintenance
14.b Gas inlet filters and traps
Replace the gas inlet filters every 6 months. For ordering information, please contact Vapotherm.
14.c Fuses
The mains fuses (two GMA - 3A F250 V, 5 x 20mm) are located next to the power cord inlet.
Use a small flat blade screwdriver to pry open the fuse compartment door to access fuses.
NOTE: Vapotherm Preventative Maintenance Kits include all parts require for annual (PM Kit
P/N 3100904) and bi-annual (PM Kit P/N 3100906) routine maintenance.
Section 15 Cleaning and disinfection
The entire disposable patient circuit is disposable and no disinfection is required. The main
unit, including the docking station for the disposable water path should be wiped down
with any of the following in 70-90% isopropyl alcohol, 2% (maximum) Chlorine cleaning
solution (Sodium Hypochlorite), or 6% (maximum) Hydrogen Peroxide cleaning solution.
In addition, the following detergent wipes may be used to remove any soil from the unit:
CaviwipesTM or Sani-Cloth
while cleaning and disinfecting.
NOTE: The transparent sensor ports in the docking station must be clean. The unit will
not operate if the sensors do not receive a clear signal.
TM
AF3 Germicidal. Unplug the Precision Flow® Plus
CAUTION: Do not use organic solvents or abrasive cleaners. Hypochlorite solutions
liberate toxic gases such as chlorine when acidified or heated. The reaction with ammonia
or wtih substances that can generate ammonia can produce chloramines which are also
toxic and have explosive potential. Do not expose the surface of the heater plate on the
Precision Flow
prolonged period of time, as this may cause surface damage to the metal plating.
3100954 Rev. A Page 25
®
Plus unit to concentrations of Chlorine solution (Sodium Hypochlorite) for a
Page 26
Section 16 Specifications
DRAFT
PHYSICAL CHARACTERISTICS
Dimensions:
Height 11.5”(300mm), width 8”(200mm), depth 7”(180mm), excluding Vapotherm approved
roll stand clamp and gas inlet filters.
Weight:
10.6 lb (4.81 kg) without disposable patient circuit
Circulating Water Volume:
400 ml approx. including delivery tube and vapor transfer cartridge.
Mounting:
Rear mounted clamp fits Vapotherm approved roll stands up to 1.5”(38mm) diameter.
Gas Connections:
Standard non-interchangeable fittings for medical air and oxygen.
FUSES: (Qty 2) GMA 3A F250 V 5mm x 20mm
SYSTEM REQUIREMENTS
Power:
100-240VAC, 50-60Hz, approx. 200VA during warm up, approx. 80VA in steady state
(depends on flow rate and temperature).
Back-up power:
4.8V nickel-metal hydride battery pack.
Gas supply:
Medical air and oxygen at inlet pressures between 4 and 85 psi (28-586 KPa).
NOTE: the full range of flows and oxygen percentage is available only if both gases are
present at inlet pressures of at least 40 psi (276 kPa). Unit is calibrated at Vapotherm
using 100% O
Water:
Sterile water in pre-filled sealed container.
PERFORMANCE
Temperature:
Range- 33 to 43°C at exit from the delivery tube, adjustable
Resolution- 1°C
Accuracy- ± 2°C
Warm up time:
± 2°C of 33°C set point < 5 minutes (at ambient 23°C)
Humidification:
Complies with ISO8185-2007 Respiratory tract humidifiers for medical use, paragraph 101
Oxygen percentage:
Range- 21 to 100% O2
Accuracy- ± 2%
Resolution- 1%
NOTE: At 22% & 23% oxygen blend, the delivered oxygen is 21%. At 98% and 99% oxygen
Ambient Pressure: Standard atmospheric – Not to be used in hyperbaric conditions
Storage and Shipping
Ambient temperature: -10 - +50°C
Ambient relative humidity: 20-90% RH
ALARM SOUND PRESSURE RANGES
Medium Priority Alarm
47 dB measured 1m from unit
Low Priority Alarm
45 dB measured 1m from unit
3100954 Rev. A Page 27
Page 28
Appendix
DRAFT
Standard Cannula
SizePart No.
PrematureMN1100A1.58
NeonatalMN1100B1.58
InfantMI13001.98
Intermediate InfantMI1300B1.98
SOLO cannulaSOLO13001.98
Pediatric SmallMPS15001.920
Pediatric/Adult SmallMP15002.740
Adult (base)MA17004.840
Audio Tone Characteristics
Prong Outer
Dia. (mm)Max. Flow
Page 28 3100954 Rev. A
Page 29
Appendix
Software operating modes
The diagram illustrates the operating modes for the unit.
• Immediately on connection to AC power a POST (Power-On Self Test) is run to verify
proper function of subsystems, sensors and actuators in the Precision Flow® Plus.
• On successfully completing the POST the unit enters STANDBY unless there is a test
failure, when the system alarms, enters FAULT mode and cannot be started.
• The Precision Flow® Plus enters RUN mode from STANDBY when the RUN/STANDBY
button is pressed. Normal operation starts. The pump, heater and gas flow proportioning
systems start. Sensors and alarms are active and flow, temperature and oxygen % can
be set.
• To return to STANDBY, the RUN/STANDBY button is pressed again and held for
2 seconds.
• If AC power is disconnected when the unit is in RUN mode it enters BATTERY mode. If
the battery is fully charged, gas mixing and metering continues for at least 15 minutes,
but water is not circulated or heated. When the battery is discharged the unit enters the
POWER OFF mode.
• If AC power is disconnected in STANDBY, the unit enters POWER OFF mode.
3100954 Rev. A Page 29
Page 30
Appendix
DRAFT
Guidance and manufacturer’s declaration -electromagnetic emissions
®
The Precision Flow
The customer or the user of the Precision Flow
Electro-Static Discharge
EN 61000-4-2:1995,+A1:1998,
+A2:2001
Radiated RF Susceptibility
EN 61000-4-3:2002
Electrical Fast Transients
EN 61000-4-4:2004
Surges
EN 61000-4-5:1995, +A1:2001
Line Conducted RF Susceptibility
EN 61000-4-6: 1996, +A1:2001
Power Frequency Magnetics
EN 61000-4-8: 1993, +A1:2001
Voltage Dips and Dropouts
EN 61000-4-11: 2004
Group 1
Class B
Class A
Complies
The Precision Flow® Plus uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby equipment.
®
The Precision Flow
other than domestic, and may be used in domestic establishments
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigating measures,
such as re-orienting or relocating the Precision Flow
shielding the location.
±6kV Contact discharge
±8kV Air discharge
80- 2500MHz @ 3 V/m,
1kHz AM 80% modulation
±5kV AC mains,
±0.5,1kV Line to line
±0.5, 1 2kV Line to protected earth
0.15-80MHz @ 3Vrms,
1kHz AM 80% modulation
3A/m @ 50/60Hz PASSED
Per Standard
Plus is suitable for use in all establishments
®
Plus or
Page 30 3100954 Rev. A
Page 31
Warranty
Vapotherm expressly warrants, for a period of one (1) year from the date of shipment by
Vapotherm to the initial purchaser of the Precision Flow® Plus device (“Customer”) that the
Precision Flow® Plus device shall meet the specications set forth in the applicable ofcial
instructions for use provided with each Precision Flow® Plus device (the “Instructions”). The
sole remedy for this warranty is that Vapotherm shall, at its sole option, either refund, repair
or replace any or all of any Precision Flow® Plus device that is defective at no cost to the
Customer. Vapotherm shall pay any shipping charges required in repairing or replacing any
part or all of a Precision Flow® Plus device during the warranty period. Thereafter, shipping
charges shall be paid by the Customer. Customer shall also be responsible for the cost of
labor for repairs. This warranty does not apply to any disposable component to the Precision
Flow® Plus device, including with limitation the disposable patient circuits and hoses supplied
with the Precision Flow® Plus device. The warranty set for herein shall become null and void if:
(1) the Precision Flow® Plus device is not used or serviced in accordance with the applicable
Instructions or any related preventative maintenance instructions provided with the Precision
Flow® Plus device; or (2) the Precision Flow® Plus device is opened or tampered with, or if
repairs or service are performed or attempted on the Precision Flow® Plus device by anyone
other than Vapotherm or a Vapotherm-certied service center.
EXCEPT AS EXPRESSLY SET FORTH ABOVE, VAPOTHERM MAKES NO WARRANTY,
EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE PRODUCTS
OR ANY OTHER ITEMS PROVIDED BY VAPOTHERM, AND HEREBY EXPRESSLY
DISCLAIMS ANY OTHER FORM OF WARRANTY, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THIS
STATED WARRANTY IS EXCLUSIVE IN LIEU OF ALLL OTHER WARRANTIES PROVIDED
BY LAW.
For further information contact:
Vapotherm Inc.
22 Industrial Drive
Exeter, NH 03833
USA
Phone: 603-658-0011
Fax: 603-658-0181
www.vapotherm.com
May be patented
www.vapotherm.com/patents
Technical Support Line
Domestic: 855-557-8276
International: 603-658-5121
TS@Vtherm.com
3100954 Rev. A Page 31
RMS – UK Limited
28 Trinity Road
Nailsea, North Somerset BS48 4NU
United Kingdom
Phone: +44-1275-85-88-91
Fax: +44-1275-85-88-91
Page 32
Vapotherm Inc.
22 Industrial Drive
Exeter, NH 03833
USA
Phone: 603-658-0011
Fax: 603-658-0181
3100954 Rev. A
Page 323100954 Rev. A
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