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3001002 Rev. T    

 

Page  7

Section 3   

Principles of operation

The Precision Flow

®

 warms and humidifies breathing gas for delivery by nasal cannula 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

® 

 consists of two parts:

Main unit

• The 

main 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. The battery is not operator replaceable.

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.

Summary of Contents for precision flow

Page 1: ...Precision Flow Instructions For Use...

Page 2: ...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 Sec...

Page 3: ...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 an...

Page 4: ...lways 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 I...

Page 5: ...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 ne...

Page 6: ...ingle 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 p...

Page 7: ...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 an...

Page 8: ...battery fully charged 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...

Page 9: ...LED indicates one or more alarms are muted 4 Setting control knob Press to select which variable to adjust Rotate to adjust to new value Press again to set value 5 Hinged door Opens to install or remo...

Page 10: ...Access panel for oxygen 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 p...

Page 11: ...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 ad...

Page 12: ...te 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...

Page 13: ...pply hoses to correct inlets then connect them to the wall outlets 7 4 Connect power cord 7 5 Open the bags containing the disposable water path vapor transfer cartridge and delivery tube and assemble...

Page 14: ...tion CAUTION Do not remove the disposable patient circuit while the unit is operating 7 6 Inserting disposable patient circuit 7 6 1 Open door to expose the docking station 7 6 2 Hold disposable patie...

Page 15: ...n 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 Instruction For Use for info...

Page 16: ...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 with the screen illuminated simply press and release the Run S...

Page 17: ...to 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 t...

Page 18: ...ion of AC power then 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 de...

Page 19: ...es less than 5 lpm WARNINGS Always follow aseptic technique including proper hand washing and avoiding direct hand contact with connection points when setting up the Precision Flow and Standard Precau...

Page 20: ...able water path is fully inserted into the docking station 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 V...

Page 21: ...rmittent 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...

Page 22: ...ed Clear obstruction check cannula type re install DPC Water out Medium Priority No water in disposable water path Gas flow continues without heat ing or water circulation Sterile water empty or obstr...

Page 23: ...tandby Replace dispos able patient circuit includ ing water path cartridge delivery tube None Cartridge and or DPC not detected STANDBY mode missing cartridge Remove disposable patient circuit Check c...

Page 24: ...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...

Page 25: ...aximum Hydrogen Peroxide cleaning solution In addition the following detergent wipes may be used to remove any soil from the unit CaviwipesTM Sani ClothTM AF3 Germicidal Incidin OxyWipe Bacillol 30 Ti...

Page 26: ...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 g...

Page 27: ...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 un...

Page 28: ...uter Dia mm Max Flow 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 Sma...

Page 29: ...n Flow 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 tempe...

Page 30: ...ectly 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...

Page 31: ...The warranty set forth herein shall become null and void if 1 the Precision Flow device is not used or serviced in accordance with the applicable Instructions or any related preventative maintenance...

Page 32: ...Page 32 3001002 Rev T 3001002 Rev T Vapotherm Inc 100 Domain Drive Exeter NH 03833 USA Phone 603 658 0011 Fax 603 658 0181...

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