Precision Flow Instructions for Use Rev B

Table of Contents

Page

Symbols

3

Section 1

Indications, Warnings and Cautions

4

Section 2

Overview

7

Section 3

Principles of operation

8

Section 4

Controls, displays & connections

10

Section 5

Modes of operation

13

Section 6

Initial assembly

14

Section 7

Setting up

15

Section 8

Adjustments

19

Section 9

Connecting to patient

20

Section 10

Operating guidelines

21

Section 11

Changing the disposable patient circuit

22

Section 12

Alarms

23

Section 13

Shut down

27

Section 14

Routine maintenance

27

Section 15

Cleaning and disinfection

28

Section 16

Specifications

29

Appendix: Audio Tone Characteristics Software modes EMC Guidance

32 33 34

Precision Flow® Packaging contains: Precision Flow® 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 Delivery Tube clip

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MR Unsafe

Vapotherm Inc. has declared that this product conforms with the European Council Directive 93/42/EEC Medical Device Directive when it is used in accordance with the instructions provided in the Instructions For Use. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as an unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

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Section 1 Indications, Warnings and Cautions General Indications & Contraindications.

Primary Indications: Precision Flow® 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: • Not appropriate for patients who are not spontaneously breathing, are unable to protect their airway or have anatomic or injury induced blockage of the nasal pathway to the nasopharyngeal space • Not for treating OSA and snoring • The Precision Flow® is not for field transport • The Precision Flow® is MRI unsafe. Do not use it in an MR environment. Warnings and Cautions A Warning indicates that a situation may occur which is potentially harmful to the patient or user. A Caution indicates a condition that may lead to equipment damage, malfunction, or inaccurate operation. A Note indicates a point of emphasis to make operation more efficient or convenient. Please take the time to familiarize yourself with the warnings, cautions, and notes listed in these instructions. They cover safety considerations, special requirements, and regulations. The user of this product shall have sole responsibility for any malfunction due to operation or maintenance performed by anyone not trained by Vapotherm staff or official training documentation. When handling any part of the Precision Flow®, always follow hospital infection control guidelines and Standard Precautions. Vapotherm also recommends that users follow the Centers for Disease Control (CDC) publications: Guidelines for Maintenance of In-Use Respiratory Therapy Equipment and Guidelines for Prevention of Nosocomial Pneumonia. General Warnings Federal Law (U.S.) restricts the sale of this device to, or by the order of any physician. This device should be used ONLY by a trained respiratory therapist or certified operator. Training is to be provided and shall be conducted by authorized Vapotherm personnel only. This is a humidification device generally used for providing continuous flows of breathing gas. The Precision Flow® is not a ventilator and should not be used as life support. Oxygen supports combustion; this device should not be used near or around open flames, oil, or grease, or flammables. Service on the device should only be performed by qualified, certified service technicians. To prevent injury, do not attempt to do any service to the Precision Flow® while a patient is connected to the device.

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Section 1 Indications, Warnings and Cautions If the device is damaged or not working properly, do not use. Contact Vapotherm or your authorized Vapotherm representative. Do not operate if power cord is damaged. No modification of the equipment is allowed. Do not modify this equipment without authorization of Vapotherm. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. The device should not be placed in run mode and left unattended in a non-care environment. When utilized in a care environment, operator shall remain close enough to hear the alarms. Do not use the Precision Flow® at an altitude above 6,392 feet or outside a temperature of 1830°C. Using the Precision Flow® outside of this temperature range or above this altitude can affect the quality of the therapy or injure the patient. Do not use the Precision Flow® in or around water, other than the sterile water supply that feeds the system. Do not use the Precision Flow® system in combination with any other system intended for humidification of respiratory gases (e.g. heat and moisture exchangers (HMES)). Do not add any attachments or accessories to the Precision Flow® that are not approved by Vapotherm. Unauthorized attachments or accessories may affect the quality of the therapy. Prior to use, the Precision Flow® should be positioned and secured to a Vapotherm approved roll stand with the base of the unit no more than 40” (102cm) above the floor to reduce risk of tipping. Make sure all Disposable Patient Circuit connections have been properly secured. The vapor transfer cartridge, disposable water path and delivery tube are labeled as single patient use only and must be replaced after 30 days use on a single patient (nasal cannula replaced as required): do not attempt to sterilize or reuse and follow all local and federal regulations for disposal. Outside the USA follow national or international regulations. Reuse of any of these components may result in mechanical failure and/or increased risk of bacterial contamination. Failure to utilize sterile water supply or clean gas supply may increase risk of bacterial contamination. •

Use aseptic technique.

•

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

Precision Flow® is not a Continuous Positive Airway Pressure (CPAP) device. There are no controls to deliver or monitor airway pressure. Precision Flow® should not be used to deliver pressure in a closed system. Never connect the unit to a patient until it reaches at least 33°C. Allow the unit to warm-up to purge condensate and prevent patient discomfort due to cold or partly humidified gas. Patients receiving supplemental oxygen are acute and appropriate clinical vigilance should be observed by the care team. Additional patient monitoring including pulse oximetry is necessary if the Precision Flow® is used to give supplementary oxygen. The Precision Flow® is MRI unsafe. Do not use it in an MR environment. 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 Precision Flow Instructions for Use 3101458-01-EN Rev. B

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Section 1 Indications, Warnings and Cautions 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. The internal battery backup maintains flow and oxygen percentage for at least 15 minutes if AC power is cut off. When the Precision Flow® is running on battery, there is no heat or humidity provided with the set flow and FiO2 and humidity level may drop below safe limits. After the battery is fully discharged the device will not operate and patient gas flow will cease. There are no alarms or display indicators after the battery has discharged. The battery is not intended for patient transport. To reduce the risk that the patient may aspirate condensed water from the breathing circuit, regularly observe the patient and output of the patient interface for excess water, and if detected, remove patient interface from the patient. Water in the center lumen can result from condensation or due to a leak from the outer lumens that surround the breathing circuit.

General Cautions Read and understand these instructions prior to operating the system. Clamp sterile water supply when not in use, including Standby mode, to prevent damage by water ingress. Aseptic techniques (including hand washing and avoiding touching connection points) and Standard Precautions should always be followed when handling medical equipment. Standard Precautions should always be followed when coming into contact with patients. Do not cover the unit; blocking the vent may damage the unit. Do not: • • •

Immerse the Precision Flow® in water. Steam or gas sterilize the Precision Flow®. Wipe with chlorine bleach solution greater than 2% strength.

Flexible sterile water bags are recommended. If rigid or semi-rigid bottles are used, a Vapotherm approved adapter must be used. NOTE: Interdependence of FiO2 and Flow are directly related to input supply pressure. The Precision Flow® may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa); however, for the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be 40 psi (276 kPa) or above. When both or either of the supply pressures are less than 40 psi, the Precision Flow® calculates the maximum achievable flow and/or titration and limits the user adjustable parameters on the user interface. The maximum limited pressure and maximum operating pressure of the Precision Flow® is 20 psi (138 kPa). Precision Flow® is not for field transport. When used with approved ancillary equipment, the Precision Flow® may be used for transferring patients within the hospital.

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Section 2 Overview The Precision Flow® 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 •

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 L/min

•

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

•

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

•

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

•

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

•

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

•

Warm-up time less than five minutes

•

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

•

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

•

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

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Precision Flow®

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Section 3 Principles of operation The Precision Flow® warms and humidifies breathing gas for delivery by a Vapotherm approved interface at flows from 1 to 40 L/min. The unit incorporates an electronic blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently. The Precision Flow® consists of two parts: Main unit • The capital unit which contains all the electrical and electronic components including the electronic blender and flow controllers, and remote sensors to monitor the disposable water path. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. •

The flow of oxygen and air are measured by mass flow sensors. The operating software calculates the required flow of each needed to reach the target flow and oxygen percentage set by the operator. The system controls gas flows accordingly by adjusting proportional solenoid valves on the gas lines. An oxygen sensor monitors the gas mixture and signals any discrepancy between target and measured percentage. The oxygen sensor is automatically calibrated with oxygen at power-up and every 24 hours.

•

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

•

After a two hour charging period, an internal battery backup will maintain the set flow and oxygen blend for at least 15 minutes without AC power. WARNING: The back-up battery is designed for temporary use only, when AC power to the unit has been interrupted. When the Precision Flow® is running on battery, there is no heat or humidity provided with the set flow and FiO2 and humidity level may drop below safe limits. After the battery is fully discharged the device will not operate and patient gas flow will cease. When fully charged, the battery provides 15 minutes of power. The battery is not intended for patient transport.

Disposable patient circuit •

•

The disposable patient circuit (DPC) is comprised of the disposable water path (DWP), vapor transfer cartridge (VTC) and delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable water path. Vapor transfer cartridge. In the cartridge, blended gas passes through the lumens of hundreds of parallel hollow fibers made of a specially developed polymer. Warm water circulates around the fibers and diffuses as vapor through the fiber material into the gas stream flowing through each fiber. Unlike most humidifiers, there is no direct contact between the water and gas streams. The gas stream leaves the cartridge saturated with vapor at the set temperature.

Note: Use only approved cartridges from Vapotherm Inc. Page 8

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Air Inlet Water Inlet

Water Outlet Air Outlet

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Section 3 Principles of operation •

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

•

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

Breathing Gas

Warm Water Flow

Warm Water Return

Cross-section of Tubing

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

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Section 4 Controls, displays & connections 16

1

15 2 14

13

3 12

11 4 5

10

6 7

9 8

1. Battery low or charging 2. Disposable water path faulty or absent 3. Vapor transfer cartridge type 4. Vapor transfer cartridge fault 5. Gas supply fault 6. Run/Stop Status LED 7. Run/Standby button (see note) 8. Setting control knob

9. Alarm mute button 10. Alarm muted LED 11. General fault 12. Water out 13. Blocked tube 14. Temperature Display 15. Flow Display 16. Oxygen % Display

Note:The Precision Flow® has no ON/OFF switch. Plug the unit into a wall outlet to keep the battery fully charged. Page 10

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Section 4 Controls, displays displays,&&connections connections Front view 1 2

3

4

1. Folding carrying handle 2. Multi-function display: • Shows set values for oxygen %, flow and temperature • Icons indicate alarm conditions and device status 3. Alarm mute: • Press to silence alarms for up to 2 minutes • LED indicates one or more alarms are muted 4. Setting control knob: • Press to select which variable to adjust • Rotate to adjust to parameter value • Press again to set value

5

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 Precision Flow Instructions for Use 3101458-01-EN Rev. B

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6

7

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Section 4 Controls, displays, & connections 1

2

3

4 5

6 7

Rear view 1. Hinged door • Open to install or remove disposable water path

8

2. Vent 3. Access panel for O2 sensor (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 O2 sensor cell that is one year from the date it is removed from its packaging. Page 12

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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

Input parameters can be adjusted, no gas flow

Amber

Run

Warming to set point temperature, gas flow

Flashing green

Unit operating at set point, gas flow

Solid green

See Appendix for a description of the software operating modes. Precision Flow Instructions for Use 3101458-01-EN Rev. B

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Section 6 Initial assembly Certain accessories must be installed in the Precision Flow® 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. WARNING: Do not position the Precision Flow® so that it is difficult to operate the disconnection of the device. 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. Oxygen Sensor Access Panel

6b. Inlet gas filter trap assemblies.

Gas inlet filters and traps are supplied in a separate box with the O2 sensor and must be 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. WARNING: Never attempt to run the Precision Flow® 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 14

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Section 7 Setting up 7-1.

Hang the sterile water supply from hook on Vapotherm approved roll stand.

7-2.

Attach the unit to Vapotherm approved roll stand below lowest point of the sterile water supply.

NOTE: The Precision Flow® 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. 7-3. Connect oxygen and air supply hoses to correct inlets, then connect them to the wall outlets. 7-4. Connect power cord.

Pole clamp

7-5. Open the bags containing the disposable water path, Oxygen Power vapor transfer cartridge, and delivery tube, and cord assemble them as follows: Air 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.

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 L/min.

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 L/min.

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Section 7 Setting up 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 16

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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. If screen is dark, press any button or turn the setting control knob prior to placing in Run mode. 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® unit may further assist with water flow 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® Instructions for Use for information regarding alarms. Additional alarm information: If a medium priority Water Out Alarm occurs, this may be due to the sterile water supply being empty, an obstructed inlet tube, or accumulation of air within the DPC. 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® unit. Press Run/Standby button to restart the unit. If alarm persists, disconnect patient from therapy. 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.

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Section 7 Setting up WARNING: Use high-flow cartridge for flows 5-40 L/min and low-flow cartridge for flows 1-8 L/min. 7-7. Plug in power cord, and check that all the display indicators light up. The Precision Flow® 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® 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® 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 Run/Standby button 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® 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 disinfect spike with 70-90% isopropyl alcohol or equivalent. 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 18

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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. Precision Flow Instructions for Use 3101458-01-EN Rev. B

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Setting control knob Page 19

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Section 8 Adjustments 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® 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 cannot be set below 5 L/min. • If a LOW-FLOW cartridge is installed the flow cannot be set above 8 L/min. NOTES on adjustment: • Transient temperature changes may occur after rapid changes in flow settings. • During warmup the temperature display shows the actual temperature 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), then the unit will return to default settings

Section 9 Connecting to patient 9-1. Wait for the unit to reach 33°C before placing the cannula (applied part) on the end of the patient delivery tube. The flashing green Status LED becomes stead when the set temperature is reached. 9-2. Check water level, temperature display, gas flow rate, and oxygen percentage. 9-3. Size cannula (applied part) 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 (applied part) 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 High Flow Low Flow

Patients weighing less than 3 Kg must always be put on Low Flow

Cannula type Adult, pediatric & small adult, pediatric small* Premature, solo, neonatal, infant, intermediate infant, pediatric small*

Operational flow rates 5-40 L/min 1-8 L/min

*Pediatric small cannula is intended to deliver flows from 1-20 L/min

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3101458-01-EN Rev B PF Classic IFU.indd 20

Precision Flow Instructions for Use 3101458-01-EN Rev. B

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