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Vapotherm Precision Flow Hi-VNI Instructions For Use Manual
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Vapotherm Precision Flow Hi-VNI Instructions For Use Manual

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Precision Flow
Hi-VNI
®
Instructions for Use

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Summary of Contents for Vapotherm Precision Flow Hi-VNI

  • Page 1 Precision Flow Hi-VNI ® Instructions for Use...

  • Page 2: Table Of Contents

    US ONLY- Air and Oxygen Hoses Nurse Call / EMR Communication Cable with adapter cables (varies by country) Quick Set Up Sticker (English speaking countries only) Delivery Tube clip Page 2 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...

  • Page 3: Symbols

    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.

  • Page 4: Indications, Warnings And Cautions

    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 Hi-VNI, always follow hospital infection ®...
  • Page 5 Section 1 Indications, Warnings and Cautions is 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. No modification of the equipment is allowed. Do not modify this equipment without authorization of Vapotherm.
  • Page 6 Precision Flow Hi-VNI is not for field transport. When used with approved ancillary ® equipment, the Precision Flow Hi-VNI may be used for transferring patients within the ® hospital. Page 6 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...

  • Page 7: Overview

    Hi-VNI 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.

  • Page 8: Principles Of Operation

    Section 3 Principles of operation The Precision Flow Hi-VNI 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.
  • Page 9 Hi-VNI’s ® data output to specific EMR system formats, then validate the functionality of the connection. Bernoulli Systems (formally Nuvon) and Capsule are the Vapotherm recommended 3rd party integrators. See Section 5 for a description of the modes of operation.

  • Page 10: Controls, Displays & Connections

    8. Setting control knob 16. Oxygen % Display Note:The Precision Flow Hi-VNI has no ON/OFF switch. Plug the unit into a wall outlet to ® keep the battery fully charged. Page 10 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...
  • Page 11 (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 Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 11...
  • Page 12 Computers or other equipment should not be plugged into the Nurse Call/EMR Port. Only Nurse Call / EMR cable (PN# 3100897) shall be used. Page 12 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...

  • Page 13: Modes Of Operation

    Amber 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 Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 13...

  • Page 14: Initial Assembly

    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 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...

  • Page 15: Setting Up

    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. Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 15...
  • Page 16 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 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...
  • Page 17 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. Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 17...
  • Page 18 “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 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...

  • Page 19: Adjustments

    Rotating the knob has no effect unless one of the settings has been selected and one of the displayed values is flashing. Setting control knob Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 19...

  • Page 20: Connecting To Patient

    1-8 L/min Patients weighing less than 3 Kg must always be put on Low Flow pediatric small* *Pediatric small cannula is intended to deliver flows from 1-20 L/min Page 20 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...
  • Page 21 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 22: 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 23: Alarms

    • low pitched buzz when you try to change a setting that cannot be changed or when alarm conditions prevent entering the run mode • five slowly repeating single beep during disposable water path testing when entering run mode. Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 23...
  • Page 24 Priority disposable water empty, or straighten inlet tube. path. Gas flow obstructed inlet Restart unit. If alarm continues without tube. persists, disconnect heating or water patient from therapy. circulation. Page 24 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...
  • Page 25 Medium Selected flow Inlet gas Increase gas pressure or Priority cannot be pressure too decrease flow setting. provided from low for current gas selected supply. flow rate. Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 25...
  • Page 26 Temperature 2° Very low water Silence alarm and wait for < set point temperature temperature to rise. after bag replacement. Page 26 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...

  • Page 27: 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 28: Cleaning And Disinfection

    Ensure that the unit is unplugged before replacing fuses. 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 29: 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 30 NOTE: At flow rates less than 3 L/min, for 22% & 23% oxygen blend, the delivered oxygen is 21%. At flow rates less than 3 L/min, for 98% and 99% oxygen blend, the delivered oxygen is 100%. Page 30 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...
  • Page 31 Instructions for Use instructions and cautions, and the timely execution of routine maintenance. More frequent use, dirty and or wet gas supplies, or the use of organic or abrasive cleaners will reduce the expected life. Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 31...
  • Page 32 Inter-Burst Tone Type Spacing Duration (Hz) per Burst Interval (s) (ms) (ms) Medium Priority Low Priority Run/Standby Transition Encoder Know Press User Interface Error Self Test 1000 DWP Detecting Page 32 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...
  • Page 33 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. Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B Page 33...
  • Page 34 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Precision Flow Hi-VNI System, including cables specified by Vapotherm. Otherwise, degradation of the ®...
  • Page 35 Hi-VNI 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 Hi-VNI device that is defective at no cost to the Customer. Vapotherm shall pay any shipping charges required ®...
  • Page 36 Vapotherm Inc. 100 Domain Drive Exeter, NH 03833 Phone: 603-658-0011 Fax: 603-658-0181 3101477-01-EN Rev B Page 36 Precision Flow Hi-VNI Instructions for Use 3101477-01-EN Rev B...