Vapotherm Precision Flow User Manual

Page 1
QUICK REFERENCE GUIDE
Battery low
or charging
(not indicative of
charge level)
Blocked tube
General fault
Water out
Alarm mute LED
Alarm mute button
Setting Control Knob
Disposable Water Path
faulty or
absent
Low Flow
Circuit
Installed
High Flow
Circuit
Installed
Vapor Transfer
Cartridge fault
Gas supply
fault
Run/Stop
Status LED
Run/ Standby
button
This guide provides you with basic instructions on how to set up and operate the Precision Flow®. Before operating the Vapotherm Precision Flow®, please review the Instructions For Use which can be found at our website www.vapotherm.com and on the USB drive provided in the Start-Up Kit.
Page 2
ALARM ICON WARNING INDICATES CAUSE ACTION
ALARM ICON WARNING INDICATES CAUSE ACTION
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 ow 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 eld transport
• The Precision Flow® is MRI unsafe. Do not use it in an MR environment.
Additional patient monitoring including pulse oximetry is necessary if the Precision Flow® is used to give supplementary oxygen.
Precision Flow® Packaging contains:
Precision Flow® Unit Power Cord US ONLY - Air and Oxygen Hoses
Check gas supply. If not
GENERAL FAULT
and
– – IN FLOW
(FLASHING)
Malfunction of sensor or control system
Internal component failure
corrected, disconnect patient. Unplug AC power, press and hold Run/Standby button for 3 seconds to clear the alarm, send for service.
GENERAL FAULT
and
– – IN 0
2
(FLASHING)
O₂ sensor fault
Depleted or defective O₂ sensor
Unplug AC power, press and hold Run/Standby button for 3 seconds to clear the alarm. Replace O2 sensor. Restart unit.
Cannot be corrected by user:
GENERAL FAULT
and
– – IN TEMP
(FLASHING)
Temperature out of range.
Overheating or temperature sensor malfunction.
disconnect patient. Unplug AC power, press and hold Run/ Standby button for 3 seconds to clear the alarm, send for
service.
No water in dispos-
WATER OUT
able water path. Gas ow continues without heating or water
Sterile water empty, or obstructed inlet tube.
Replace water bag or straighten inlet tube. Restart unit. If alarm persists, disconnect patient from therapy.
circulation.
If disposable water path is present, place unit into Standby, remove and replace disposable patient circuit to reset detector. Restart unit.
DISPOSABLE WATER PATH
(FLASHING)
BATTERY
CHARGING
(STEADY)
Disposable water path faulty or not detected. Unit will not run.
Disposable water path defective, not properly seated or not installed.
The internal battery backup is not fully charged. The 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
BATTERY
(FLASHING)
in BATTERY mode. Gas ow and blending continues without heat or water circulation.
AC power is disconnected
Reconnect AC power.
Obstructed or
BLOCKED TUBE
(FLASHING)
High back pressure
kinked cannula/ delivery tube, incor­rect cannula for
Clear obstruction, check
cannula type, re-install DPC ow rate or DPC improperly seated
GENERAL FAULT ALARMS:
indicated by this icon accompanied by the Temp display showing numbers between 50 & 84 (error codes) and dashes in 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, rst 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.
Failures in the control or measurement systems will cause a General Fault alarm
CANNULA FLOW RATES
CARTRIDGE CANNULA TYPE OPERATIONAL FLOW RATES
High Flow Adult, Pediatric/Adult Small, Pediatric Small* 5-40 liters per minute (L/min)
Low Flow Premature, Neonatal, Infant, Intermediate Infant,
Solo, Pediatric Small*
*Pediatric Small cannula is intended to deliver ow rates of 1-20 L/min
1-8 liters per minute (L/min)
Page 3
ALARM ICON WARNING INDICATES CAUSE ACTION
LO HI
CARTRIDGE
FAU LT
CARTRIDGE
TYPE
GAS SUPPLY
(FLASHING)
GAS SUPPLY
(CONTINUOUS
AND FLOW
RATE NUMERIC
DISPLAY
FLASHES)
TEMPERATURE
NUMERIC
DISPLAY
FLASHES
Disconnect patient. Remove
Cartridge and/or DPC not detected. Unit will not run.
RUN mode: faulty sensor or cartridge not detected.
disposable patient circuit. Check cartridge installation. Check sensor windows are clean.
Disconnect patient. Place Gas bubbles in water circulation. Unit continues to operate.
Excessive gas diusion through cartridge bers.
unit into Standby. Replace
disposable patient circuit
including water path,
cartridge & delivery tube.
Cartridge and/or DPC not detected.
STANDBY mode: missing cartridge.
Remove disposable
patient circuit. Check
cartridge installation.
Indicates type of cartridge installed (low or high ow). Not an alarm.
Gas supply pressure outside 4-85 psi (28-586 kPa) range. Unit will not operate.
Selected ow can not be provided from current gas supply.
Gas supply is disconnected or exhausted.
Inlet gas pressure too low for select­ed ow rate.
Check gas supply and correct
as necessary.
Increase gas pressure or
decrease ow setting.
User enters set
Temperature 2° > set point
point much lower than previous
Silence alarm and wait for
temperature to drop.
temperature.
Temperature 2° < set point
Very low water temperature after bag replacement.
Silence alarm and wait for
temperature to rise.
INDICATIONS, WARNINGS AND CAUTIONS
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 ow 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 eld transport
• The Precision Flow® is MRI unsafe. Do not use it in an MR environment.
Additional patient monitoring including pulse oximetry is necessary if the Precision Flow® is used to give supplementary oxygen.
Precision Flow® Packaging contains:
Precision Flow® Unit Power Cord US ONLY - Air and Oxygen Hoses
Instructions For Use on USB Quick Reference Guide Air & Oxygen Inlet Particulate Traps with Connectors O2 Sensor cell Delivery Tube clip
Page 4
DISPOSABLE PATIENT CIRCUIT
• Assemble Disposable Patient Circuit according to provided instructions.
• Open door and install Disposable Water Path into docking station so there is no gap between bottom of the Disposable Water Path and the Docking Station Floor
• Hang sterile water bag or bottle
• Wipe water spike with alcohol pad or equivalent and insert into sterile water bag
• Allow a minimum of 200ml of water to ll into the Disposable Patient Circuit
• Precision Flow is ready for start up
START UP AND ADJUSTING PARAMETERS
• Install oxygen sensor. Replace sensor annually
• Install gas inlet lters on back with lter bowls vertical (glass side down). Replace gas inlet lters every six months
• Attach air & O₂ hoses. Plug in power cord
• Rotate the blue Setting Control Knob to illuminate display
• Press in Setting Control Knob to select the parameter and rotate to adjust the value
• Press and release (do not hold) the Run/Standby button once to start A GREEN light indicates RUN mode (AMBER light indicates STANDBY mode, No Flow)
• Green light will stop ashing once temperature is reached
CONNECT TO PATIENT
• The ashing green LED becomes steady when the set variables are reached
• Place the cannula on the patient. Once the unit has reached at least 33°C, connect to delivery tube
• The unit should not be placed in Standby mode for extended periods of time. For pauses in therapy, keep unit in RUN mode, remove cannula from the patient, and set the parameters to the lowest available setting. To reinitiate therapy, before cannula is placed on patient, clear accumulated condensate
INTERNAL BATTERY BACK-UP
• The back-up battery is designed for temporary use only, when AC power to the unit has been interrupted
• The unit will enter into battery mode and will maintain ow and oxygen percentage for at least 15 minutes
• The battery icon will ash
• Replace battery every two years
• Battery recharges in two hours
SHUT DOWN
• Press the Run/Standby button. Unit will enter Standby mode (No Flow), indicated by the AMBER light
• Clamp the water inlet tube. Open the door, remove the Disposable Patient Circuit (includes delivery tube & cartridge) by sliding it upwards out of the docking station
• Discard all disposables according to hospital guidelines
• Disconnect unit from AC power
• Wipe down with Super Sani-Cloth®. In addition, if hospital procedures require, the following may be used: 70-90% Isopropyl Alcohol, 2% (maximum) chlorine cleaning solution, 6% (maximum) Hydrogen Peroxide cleaning solution, CaviWipesTM, AF3 Germicidal, Incidin® OxyWipe, Bacillol® 30 Tissues, Clinell® Alcohol Wipes, or Tue Disinfectant Wipes
VAPOTHERM, INC.
100 Domain Drive Exeter, NH 03833 T: 603-658-0011 USA
3101540 Rev. A
May be patented. www.vapotherm.com/patents
Technical Support
T: 855 557 8276 Domestic +1 (603) 658-5121 International ts@vtherm.com
0297
RMS-UK Ltd. 28 Trinity Road Nailsea, North Somerset BS48 4 NU United Kingdom
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