Vapotherm Precision Flow Instructions For Use Manual
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Vapotherm Precision Flow Instructions For Use Manual

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Precision Flow
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Instructions For Use

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Summary of Contents for Vapotherm Precision Flow

  • Page 1 Precision Flow ® Instructions For Use...

  • Page 2: Table Of Contents

    Section 14 Routine maintenance Section 15 Cleaning and disinfection Section 16 Specifications Appendix: Audio Tone Characteristics Software modes EMC Guidance Precision Flow Packaging contains: ® Precision Flow Unit ® Instructions For Use (USB) Quick Reference Guide Power Cord Sensor cell Air &...

  • Page 3: Symbols

    Symbols 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. 0297 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.

  • Page 4: 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.
  • Page 5 ® • Steam or gas sterilize the Precision Flow • Wipe with chlorine bleach solutions 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. ®...

  • Page 6: Overview

    ® 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.

  • Page 7: Principles Of Operation

    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.

  • Page 8: Controls, Displays & Connections

    14. Temperature display 7. Run/Standby button (see note) 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 8 3001002 Rev. T...
  • Page 9 Section 4 Controls, displays & connections Front view 1. Folding carrying handle 2. Multi-function display: • Shows set values for oxygen %, flow and temperature • Icons indicate alarm conditions 3. Alarm mute: • Press to silence alarms for up to 2 minutes •...
  • Page 10 Section 4 Controls, displays & connections Rear view 1. Hinged door • Open to install or remove disposable water path 2. Vent 3. Access panel for oxygen sensor (see note) 4. Pole clamp 5. Power cord connection and fuse holder 6.

  • Page 11: Modes Of Operation

    Section 4 Controls, displays & connections WARNING: Heater plate may Docking station for disposable water path be hot! Arrows show location 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...

  • Page 12: Initial Assembly

    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 country- specific.The power cord plugs into the IEC60320-compliant receptacle on the rear panel.

  • Page 13: Setting Up

    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.
  • Page 14 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.
  • Page 15 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 Instruction For Use for information regarding ®...
  • Page 16 Section 7 Setting up 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. The Precision Flow ® performs a self-test: • all icons and numeric displays light up for a few seconds •...

  • Page 17: Adjustments

    (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.

  • Page 18: Connecting To Patient

    Section 8 Adjustments • 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. •...

  • Page 19: Operating Guidelines

    • Change nasal cannulas when soiled. NOTES: • The Vapotherm approved interface should be connected to the patient only when the unit has reached at least 33°C. • Droplets of condensation may appear at the end of patient delivery tube while unit is warming up.

  • Page 20: Changing The Disposable Patient Circuit

    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.

  • Page 21: Alarms

    (slow double beeps). ® In addition to the medium and low alarms, the Precision Flow emits the following audio signals: • single dull tone that sounds when the unit switches from run to standby mode •...
  • Page 22 Section 12 Alarms Alarm Table Alarm icon Audio Signal Indicates Cause Action General fault Medium Malfunction of Internal compo- Check gas supply. If and " - - " in Priority sensor or con- nent failure or not corrected, discon- flow Cannot be trol system insufficient gas...
  • Page 23 Section 12 Alarms Alarm Table Alarm icon Audio Indicates Cause Action Signal Cartridge fault Medium Cartridge and/ RUN mode: Disconnect patient. Remove Priority or DPC not faulty sensor disposable patient circuit. detected. Unit or cartridge not Check cartridge installation. will not run detected.

  • Page 24: Shut Down

    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.

  • Page 25: Cleaning And Disinfection

    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 required for annual (PM Kit P/N 3100904) and biennial (PM Kit P/N 3100906) routine maintenance.

  • Page 26: Specifications

    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 for inhalation in pre-filled sealed container.
  • Page 27 45 dB measured 1m from unit EXPECTED LIFE ® The Precision Flow has an expected life of 5 years with typical use of roughly 150 days per year. Actual life will vary depending on whether typical use is greater than 150 days per year, quality of gas supplies, cleaning with proper agents, operating per Instructions for Use instructions and cautions, and the timely execution of routine maintenance.

  • Page 28: Appendix

    Appendix Standard Cannula Prong Outer Size Part No. Dia. (mm) Max. Flow Premature MN1100A Neonatal MN1100B Infant MI1300 Intermediate Infant MI1300B SOLO cannula SOLO1300 Pediatric Small MPS1500 Pediatric/Adult Small MP1500 Adult (base) MA1700 Audio Tone Characteristics Page 28 3001002 Rev. T...

  • Page 29: Software 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 ® • 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.

  • Page 30: Emc Guidance

    Guidance and manufacturer’s declaration - electromagnetic emissions The Precision Flow® is intended for use in the electromagnetic environment specified below. The customer or the user of the Precision Flow® should assure that it is used in such an environment. Emissions test...
  • Page 31 Customer. ® Vapotherm shall pay any shipping charges required in repairing or replacing any part or all of a Precision Flow device during the warranty period. Thereafter, shipping charges shall be paid by ®...
  • Page 32 Vapotherm Inc. 100 Domain Drive Exeter, NH 03833 Phone: 603-658-0011 Fax: 603-658-0181 3001002 Rev. T Page 32 3001002 Rev. T...

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