Vapotherm Precision Flow Plus User Manual

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Precision Flow® Plus

Instructions for Use

Page 2

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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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.

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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

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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.

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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

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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

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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:

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Section 4 Controls, displays, & connections

DRAFT

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

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Section 4 Controls, displays, & connections

Front view

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

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Section 4 Controls, displays, & connections

DRAFT

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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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

Mode Action Indicator light color

Sleep Display in sleep mode, no gas flow Amber

Standby Display flashes 00; parameters can be adjusted, no gas flow Amber

Run Warming to set point temperature, gas flow

Unit operating at set point, gas flow

See Appendix for a description of the software operating modes.

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Flashing green

Solid green

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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

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.

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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.

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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

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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

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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)

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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.

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Setting control knob

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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:

Cartridge Cannula type Operational 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.

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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 icon Audio Signal Indicates Cause Action

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)

Blocked tube (flashing)

Water out Medium

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

None The 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

Clear obstruction, check cannula type, re-install DPC

Disconnect patient. Replace water bag or straighten inlet tube. Restart unit.

If disposable water path is present, remove and replace to reset detector.

Reconnect AC power.

Page 22 3100954 Rev. A

Page 23

Section 12 Alarms

Alarm Table

Alarm icon Audio

Cartridge fault

Cartridge type None Indicates type of cartridge installed (low or high flow). Not an

Signal

Medium Priority

Low Priority

None Cartridge and/

Indicates Cause Action

Cartridge and/ or DPC not detected. Unit will not run

Gas bubbles in water circulation. Unit continues to operate.

or DPC not detected.

alarm.

RUN mode: faulty sensor or cartridge not detected.

Excessive gas diffusion through cartridge fibers.

STANDBY mode: missing cartridge.

Disconnect patient. Remove disposable patient circuit. Check cartrridge installation. Check sensor windows are clean.

Disconnect patient. Shut off unit. Replace disposable patient circuit including water path, cartridge & delivery tube.

Remove disposable patient circuit. Check cartridge installation.

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 Cannot be muted

None Temperature 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.

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

blend, the delivered oxygen is 100%.

Page 26 3100954 Rev. A

Page 27

Section 16 Specifications

PERFORMANCE Flow rate:

STANDARDS

Designed to conform to the following standards:

IEC 60601-1

UL60601-01

CSA C.22.2/No. 601.1

AS/NZS 3200.1.2

EN60601-1

ISO 8185

ISO 11195

ISTA-2A

ENVIRONMENTAL

Operating

Ambient temperature: 18-30°C

Ambient relative humidity: 0-90% RH non-condensing

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

Size Part No.

Premature MN1100A 1.5 8

Neonatal MN1100B 1.5 8

Infant MI1300 1.9 8

Intermediate Infant MI1300B 1.9 8

SOLO cannula SOLO1300 1.9 8

Pediatric Small MPS1500 1.9 20

Pediatric/Adult Small MP1500 2.7 40

Adult (base) MA1700 4.8 40

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

Emissions test Compliance Electromagnetic environment- guidance

Plus is intended for use in the electromagnetic environment specified below.

Plus should assure that it is used in such an environment.

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Guidance and manufacturer’s declaration- electromagnetic immunity

IEC 60601-1-2:2001+A1:2004 EN60601-1-2:2001 AS/NZ3200.1.2:2005

Sub Test Passed Parameters

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 specications set forth in the applicable ofcial 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-certied 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 32 3100954 Rev. A