QUICK REFERENCE GUIDE Battery low or charging (not indicative of charge level) Disposable Blocked tube Water Path faulty or absent General fault Low Flow Circuit Installed High Flow Water out Circuit Installed Alarm mute LED Vapor Transfer Cartridge fault Alarm mute Gas supply button fault Setting Control Run/Stop Knob Status LED Run/Standby button This guide provides you with basic instructions on how to set up and operate the Precision Flow® Heliox. Before operating the Vapotherm Precision Flow® Heliox, 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. ALARM ICON WARNING INDICATES CAUSE ACTION ALARM ICON WARNING INDICATES CAUSE ACTION Check gas supply. If not Disconnect patient. Remove corrected, disconnect patient. GENERAL FAULT Malfunction of Cartridge and/or DPC not RUN mode: faulty disposable patient circuit. and Internal Unplug AC power, press and sensor or cartridge Check cartridge installation. – – IN FLOW sensor or control detected. Unit will not run. system component failure hold Run/Standby button for not detected. Check sensor windows are (FLASHING) 3 seconds to clear the alarm, clean. send for service. Disconnect patient. Place CARTRIDGE FAULT Gas bubbles in water Excessive gas unit into Standby. Replace GENERAL FAULT Unplug AC power, press and circulation. Unit diffusion through disposable patient circuit and O₂ sensor fault Depleted or hold Run/Standby button for continues to operate. cartridge fibers. including water path, – – IN 02 defective O₂ sensor 3 seconds to clear the alarm. cartridge & delivery tube. (FLASHING) Replace O2 sensor. Restart unit. Remove disposable Cartridge and/or DPC STANDBY mode: patient circuit. Check Cannot be corrected by user: not detected. missing cartridge. cartridge installation. disconnect patient. Unplug AC GENERAL FAULT Overheating or and power, press and hold Run/ Temperature temperature sensor – – IN TEMP out of range. Standby button for 3 seconds (FLASHING) malfunction. to clear the alarm, send for CARTRIDGE TYPE Indicates type of cartridge installed (low or high flow). Not an alarm. service. No water in dispos- able Sterile water empty, Replace water bag or straighten water path. Gas flow inlet tube. Restart unit. If alarm GAS SUPPLY WATER OUT or obstructed inlet Gas supply pressure Gas supply is continues without tube. persists, disconnect patient (FLASHING) outside 4-85 psi Check gas supply and correct heating or water from therapy. (28-586 kPa) range. disconnected or as necessary. circulation. exhausted. GAS SUPPLY Unit will not operate. (CONTINUOUS If disposable water path is Disposable water Disposable water AND FLOW Selected flow can not Inlet gas pressure present, place unit into RATE NUMERIC DISPOSABLE path faulty or not path defective, not be provided from current too low for Increase gas pressure or WATER PATH Standby, remove and replace DISPLAY decrease flow setting. (FLASHING) detected. Unit will properly seated or disposable patient circuit to FLASHES) gas supply. selected flow rate. not run. not installed. reset detector. Restart unit. User enters set point much lower Silence alarm and wait for Temperature 2° > set point than previous temperature to drop. BATTERY The internal battery backup is not fully charged. The unit would not run on TEMPERATURE CHARGING battery for the full rated time in the event of a power failure. No action is NUMERIC temperature. (STEADY) necessary. DISPLAY FLASHES Very low water Silence alarm and wait for Temperature 2° < set point temperature after temperature to rise. The unit is running bag replacement. in BATTERY mode. BATTERY Gas flow and AC power is Reconnect AC power. (FLASHING) blending continues disconnected INDICATIONS, WARNINGS AND CAUTIONS without heat or water circulation. Primary Indications: Obstructed or The Precision Flow® Heliox is intended to add warm moisture to breathing gases from an external source for kinked cannula/ administration to a neonate/infant, pediatric and adult patients in the BLOCKED TUBE High back pressure delivery tube, incor- Clear obstruction, check hospital, subacute institutions, and home settings. It adds heat and moisture to a blended medical heliox (79% (FLASHING) rect cannula for cannula type, re-install DPC flow rate or DPC helium, 21% oxygen)/ oxygen mixture and assures the integrity of the precise heliox/oxygen mixture via an improperly seated integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. GENERAL FAULT ALARMS: Failures in the control or measurement systems will cause a General Fault alarm Contraindications: General: indicated by this icon accompanied by the Temp display showing numbers between 50 & 84 (error codes) and • Not appropriate for patients who are not spontaneously breathing, are unable to protect their airway or have anatomic or dashes in O₂ and Flow displays. When an error code is displayed, gas delivery is stopped. The user needs to monitor injury induced blockage of the nasal pathway to the nasopharyngeal space the treatment and respond to general fault alarms. General Fault alarms cannot be silenced with the mute button. To reset, first disconnect the unit from AC power and then press the Run/Standby Button. With the exception of O₂ • Not for treating OSA and snoring sensor replacement, the unit must be repaired by an approved service facility. • The Precision Flow® Heliox is not for field transport • The Precision Flow® Heliox is MRI unsafe. Do not use it in an MR environment. CANNULA FLOW RATES Additional patient monitoring including pulse oximetry is necessary if the Precision Flow® Heliox is used to give CARTRIDGE CANNULA TYPE OPERATIONAL FLOW RATES supplementary oxygen. High Flow Adult, Pediatric/Adult Small, Pediatric Small* 5-40 liters per minute (L/min) Precision Flow® Heliox Packaging contains: Low Flow Premature, Neonatal, Infant, Intermediate Infant, 1-8 liters per minute (L/min) Precision Flow® Heliox Unit Instructions For Use on USB Quick Reference Guide Solo, Pediatric Small* Power Cord Delivery Tube clip O2 Sensor cell *Pediatric Small cannula is intended to deliver flow rates of 1-20 L/min US ONLY - Heliox and Oxygen Hoses ALARM ICON WARNING INDICATES CAUSE ACTION ALARM ICON WARNING INDICATES CAUSE ACTION Check gas supply. If not Disconnect patient. Remove corrected, disconnect patient. GENERAL FAULT Malfunction of Cartridge and/or DPC not RUN mode: faulty disposable patient circuit. and Internal Unplug AC power, press and sensor or cartridge Check cartridge installation. – – IN FLOW sensor or control detected. Unit will not run. system component failure hold Run/Standby button for not detected. Check sensor windows are (FLASHING) 3 seconds to clear the alarm, clean. send for service. Disconnect patient. Place CARTRIDGE FAULT Gas bubbles in water Excessive gas unit into Standby. Replace GENERAL FAULT Unplug AC power, press and circulation. Unit diffusion through disposable patient circuit and O₂ sensor fault Depleted or hold Run/Standby button for continues to operate. cartridge fibers. including water path, – – IN 02 defective O₂ sensor 3 seconds to clear the alarm. cartridge & delivery tube. (FLASHING) Replace O2 sensor. Restart unit. Remove disposable Cartridge and/or DPC STANDBY mode: patient circuit. Check Cannot be corrected by user: not detected. missing cartridge. cartridge installation. disconnect patient. Unplug AC GENERAL FAULT Overheating or and power, press and hold Run/ Temperature temperature sensor – – IN TEMP out of range. Standby button for 3 seconds (FLASHING) malfunction. to clear the alarm, send for LO HI CARTRIDGE Indicates type of cartridge installed (low or high flow). Not an alarm. service. TYPE No water in dispos- able Sterile water empty, Replace water bag or straighten water path. Gas flow inlet tube. Restart unit. If alarm GAS SUPPLY WATER OUT or obstructed inlet Gas supply pressure Gas supply is continues without tube. persists, disconnect patient (FLASHING) outside 4-85 psi Check gas supply and correct heating or water from therapy. (28-586 kPa) range. disconnected or as necessary. circulation. exhausted. GAS SUPPLY Unit will not operate. (CONTINUOUS If disposable water path is Disposable water Disposable water AND FLOW Selected flow can not Inlet gas pressure DISPOSABLE present, place unit into RATE NUMERIC Increase gas pressure or WATER PATH path faulty or not path defective, not DISPLAY be provided from current too low for Standby, remove and replace decrease flow setting. (FLASHING) detected. Unit will properly seated or disposable patient circuit to FLASHES) gas supply. selected flow rate. not run. not installed. reset detector. Restart unit. User enters set point much lower Silence alarm and wait for Temperature 2° > set point than previous temperature to drop. BATTERY The internal battery backup is not fully charged. The unit would not run on TEMPERATURE CHARGING battery for the full rated time in the event of a power failure. No action is NUMERIC temperature. (STEADY) DISPLAY necessary. FLASHES Very low water Silence alarm and wait for Temperature 2° < set point temperature after temperature to rise. The unit is running bag replacement. in BATTERY mode. BATTERY Gas flow and AC power is Reconnect AC power. (FLASHING) blending continues disconnected INDICATIONS, WARNINGS AND CAUTIONS without heat or water circulation. Primary Indications: Obstructed or The Precision Flow® Heliox is intended to add warm moisture to breathing gases from an external source for kinked cannula/