Common Patient Questions:

‍Question--Answer

How many times a day do I have to do this?--Twice per day; two sessions within a 24-hour period (midnight to midnight)What if I can’t do the sessions at least 6 hours apart?--At the end of the day, finding time to complete 2 sessions in less than 6 hours will still lead to better results, compared to just doing 1 or none.How/why does this work?--Freespira trains you to control your breathing rate and exhaled CO2 levels in order to stabilize and normalize your breathing pattern.Should I stay on my medications?--Freespira is an adjunctive treatment, meaning it is meant to be used in conjunction with the other treatment modalities you have been given by your providers.Should I still do my session if I’m having a panic attack?--During a panic attack it is best to wait to complete a breathing session. Doing a breathing session post panic attack can help your body recover more quickly.What should I do if I can’t breathe through my nose?--Sometimes allergies and getting sick can impact our ability to breathe through our noses. If you’re unable to breathe through your nose, contact your coach immediately to let them know.Can I do more than 2 sessions a day?--A max of 2 sessions per day is recommended, and, if you wish to practice more, speak to your coach about ways to complete extra practice in between sessions.Can I do the breathing exercises lying down?--Please do the breathing sessions while in a seated position with your eyes open to encourage muscle memory that supports you learning how to bring this skill into practice outside of sessions.Is there any medication in the cartridges?--No; the purpose of the cartridges is purely a technology piece to ensure the accuracy of the breath detection.How will this work when nothing else has worked?--Although there is no guarantee, please note that 86% of people who complete treatment report a reduction or elimination of physiological symptoms by the end of treatment.

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‍Technical FAQ:

‍Question--Answer

‍What is FS3?--This refers to Freespira 3, the only FDA-cleared treatment proven to reduce or eliminate panic attacks and post-traumatic stress disorder (PTSD) symptoms. Unlike medication or talk therapy, in 28 days Freespira addresses the underlying breathing irregularities for individuals suffering from these debilitating anxiety conditions.Define cal--CalibrationDefine cal cart--Calibration CartridgeDefine MU--Measurement UnitWhat is film?--CO2 sensitive paper stored within the measurement unit. While in the presence of CO2 it will change color.What is film damage?--Film should be uniform dark blue color, and ideally have no spots or scratches on the film. Other damage types are listed below.Yellow Spots/Scratches: Yellowing of the film indicates permanent damage to the film cell due to chemical contamination or water damage. (Worst damage)Spotting/Robin Egging: Spotting appears, usually, as small dark blue dots and scratches. If the film appears to have more than 30% of the film contaminated, then the film shall be scrapped.Non-uniformity: If the film cell appears non-uniform in color, then it is possible the film will not react properly when in the presence of CO2. Non-uniformity appears as swathes of lighter/darker blue tone.Define ChA/B/C/D--Channel A/B/C/D are voltage readings from the sensor located within the measurement unit. They are used to quantify the change in color of the film.What does brick’d mean?--When a sensor is allowed to discharge for a long period of time the voltage in the battery will drop and be unable to charge via USB. Instead, the sensor will need to be opened and jumped with a power supply unit to jumpstart charging.Define FsDiag--Freespira IDE used to program and debug sensors.Define FAT and/or FAT Test--Final Assembly Test procedure. Used to validate expected sensor functionality before sending out to patients. TP – 4081 Test Procedure, FINAL ASSEMBLY, FS3Define ROSE--Production test fixture for calibration and final testing sensors. Can only test one sensor at a time.Define MMH--Manufacturing Multi – Host is used to calibrate and final test multiple sensors simultaneously.What does RR stand for?--Respiration Rate in breaths per minute (BPM)What tools or equipment are needed to work on the FS3?--Phillips Screwdriver: used on the Sensor housing and circuit boardT6 Screwdriver: used to Disassemble MUMicroscope: to Examine film cell and circuitryDental tool: used for Removal of cannula cover on sensorSpudger tool: used to Remove faceplate and adjust tubing within housing.Calibration Cartridge: Calibration gas used for testing.Calibration torque driver: used to Install faceplate and ringlight edgelitSoftware Final Testing: Production FAT testing--FSdiag + Rose suite is used by production to calibrate and final test sensors. Can only test one sensor at a time.The software for Rose is on LabVIEW and a separate computer is used to run FSdiag to monitor the CO2 levels.TP – 4081 Test Procedure, FINAL ASSEMBLY, FS3Below is the script used to run FAT testing on the Rose system.LabVIEW Script:C:\LabView\BKUP_PAHS_Instrument_Jan_3_2016\PAHSMain.viSoftware Final Testing: Engineering FAT testing--The MMH is used to test multiple sensors.MPI: Currently a work in progressNot production ready as of 9/17/21How to set up for Hardware Testing--Describe your test hardware setup. Include pictures and/or diagrams if useful. If applicable, reference another test plan’s test hardware setup.What is the test procedure?--General StepsFirst step will always be to see if the error is reproduceable. Most issues can be solved with a fresh calibration cartridge and recalibration. All troubleshooting steps below should be attempted after recalibration has failed or the error was reproduced.Append new errors not in the guide and include the steps used to troubleshoot said problem.What to do for Failure Mode: Failed Char Offsets--1. Swap out MU and check original MU for film damagea. Reset char hours2. Move to location or create environment with as low ambient CO2 as possible and recalibrate3. Check tubing for pinches/disconnection or debris4. Check if calibration cartridge is difficult to install or if there is a sound of a leak.a. If leaks are heard inspect button and make sure BirdPrecision fitting has Loctite on Bird Precision fitting threads.b. If calibration cartridge seems exceptionally difficult tolatch, measure the force required to latch the calibrationcartridge with a force gauge.i. If the force required exceeds 12 lbf examine the button assembly.ii. Check if the O ring on the button assembly is worn out, if so replace.iii. Replace the button assembly.What to do for Failure Mode: Sensor can’t communicate with FsDiag--1. Check if USB connection is loosea. If yes replace triangle board2. Check triangle circuit board for shorted pinsa. if yes replace triangle board3. Check triangle circuit board for broken inductora. if yes replace triangle boardWhat to do for Failure Mode: Tablet Frozen--1. Hold the power button down to turn tablet off, then turn back onWhat to do for Failure Mode: Sensor Frozen--1. Take a small pin and hit the sensor reset, located under the sensor charging portWhat to do for Failure Mode: Bluetooth connection errors--1. If tablet and sensor can’t connect, turn off tablet and sensor, turn back on and re-try2. If issue persists, turn the sensor on and go into the Freespira App. Go into the “Settings” tab and click the “More” button. Hit “Select Sensor” and tap the sensor number that matches the serial number on the back of the sensorWhat to do for Failure Mode: Failed Span Calculation (Error code: Stage 3)--1. Attempt to calibrate with a new piece of film2. Check for high room air3. Make sure sensor temperature is not too cold4. Attempt to calibrate sensor with a different MU5. Check that LEDs are reading correctly6. Make sure calibration cartridge is new and full of gas7. Check that FilmCharCoefs were programmed correctly8. Check original MU with a different sensora. If successful blow out the sensori. If no flow change orificeWhat to do for Failure Mode: USB Disconnects from sensor--1. Test USB cable with cable testing procedure2. Disassemble sensor and check triangle board for damage.3. Check if USB connection is loose4. If yes replace triangle boardWhat to do for Failure Mode: Sensor isn’t charging and/or LEDs aren’t on--1. Check if the sensor has been brick’d, if it has jump the sensor with 3.3 volts until it is charged.2. If that doesn’t work check the voltage across the battery. If it is ~0 Volts, the microchip on the battery may have disconnected the battery to prevent over discharging.a. Remove the faceplate and pop off the main circuit boardb. Disconnect the battery and charge it with ~3.2 volts with a current limit of <= 200mA3. Check for damaged LED(s) and replace as necessary4. Replace the triangle board5. Replace the main boardWhat to do for Failure Mode: Failed Gain Limit Check (Error code: Stage 9)--1. Move to location or create environment with as low ambient CO2 as possible and recalibrate2. Turn sensor on/off a few times to allow for solenoid switching to occur.3. Check if solenoids are leaking4. Check if solenoid is broken and is pulling from canula port instead of calibration cartridge (while patient had cannula in, this could have created a high room air reading)5. Check if calibration cartridge is difficult to install or if there is a sound of a leak.a. If leaks are heard inspect button and make sure BirdPrecision fitting has Loctite on Bird Precision fitting threads.b. If calibration cartridge seems exceptionally difficult to latch, measure the force required to latch the calibration cartridge with a force gauge.i. If the force required exceeds 12 lbf examine the button assembly.ii. Check if the O ring on the button assembly is worn out, if so replace.iii. Replace the button assembly.6. Open and examine MU film cell for damage and/or non-uniformity, ability to change color when breathed on.7. Perform MU vacuum check and try again8. Swap out with another MUa. If failed, test original MU with another sensor.9. Open original sensor and inspect tubing, make sure tubing is connected, not pinched, no debris.10. Blow out sensor and check airflow -> recalibratea. If the flow is not at least 55mL/min, replace bird precision fitting and try recalibrating11. Replace transition board -> recalibrate12. If original MU works then sensor should have FW reloaded, reprogrammed, then recalibrated.What to do for Failure Mode: Cannula Pinched/Blocked info warning in FsDiag--1. Recalibrate sensor and see if cannula pinched/blocked warning is reproduceable.2. Replace cannula3. If the warning remains disassemble the sensor and examine the tubing to make sure no tubes are pinched and the tubes are in the correct position.4. While disassembled run another calibration to see if removing faceplate allows for the tubes to unwind.a. If warning disappears reassemble sensor making sure the cannula tube is behind the motor when placing the faceplate back on.b. Otherwise replace tubing try calibration again.5. Perform a blow out on sensor.6. If errors continue, escalate to engineering.What to do for Failure Mode: No Flow during blowout TDN – 0034--1. Perform blow out and check for flow if no flow cont.2. Clean orifice with q-tip + alcohol3. Check for audible flow from sol1 and sol 2 commands from register control4. Inspect tubing for pinch or disconnected tubing and make sure no debris in tubinga. Replace pinched tubingb. If debris perform blowoutc. If debris rust -> replace solenoid5. Inspect solenoid installed correctly (not upside down).6. Remove 2mm blue tube from barbed fitting on Bird Precision orifice7. Rerun TDN 34 without attaching flow meter and with 2mm blue tube exhausting to atmosphere.8. Check to make sure air flow audible from 2mm tubing.9. .0016” could be clogged -> replace button assemblya. If that doesn’t work create new NCMR -> escalate to engineeringWhat to do for Failure Mode: Failed to Humidify (Error code: Stage 1)--1. Check if calibration cartridge is difficult to install or if there is a sound of a leak.2. Check if calibration cartridge is difficult to install or if there is a sound of a leak.a. Verify the seal tab was securely sealing the moisture ports on the calibration cartridge.b. Use a new calibration cartridgec. Inspect the square O ring at the moisture port and replace if system cannot humidify in a dry ambient environmentd. If calibration cartridge seems exceptionally difficult to latch, measure the force required to latch the calibration cartridge with a force gauge.i. If the force required exceeds 12 lbf examine the button assembly.ii. Check if the O ring on the button assembly is worn out, if so replace.iii. Replace the button assembly.What to do for Failure Mode: Sensor lacked overshoot during respiration rate testing--Calibrate sensor and breathe into sensor using monitor mode on FSdiag2. Check voltage on ChAa. If no overshoot detected this could indicate film damage.i. If film is damaged it may react slower to the presence of CO2 or not able to react to it at all. Examine the film and replace if necessary.What to do for Failure Mode: Failed FAT test during switched gas (simulated respiration)--1. Recalibrate and retest final test using a new calibration cartridge2. If CO2 was below threshold during final test, then examine/replace film cell.What to do for Failure Mode: Charging LEDs not sequencing--1. Plug in power adapter and check if sensor can start sequencing.2. If been the sensor has been inactive for 3+ months jump start sensor with 3.3V while plugged into a charger.3. Allow the sensor to charge for a bit.4. Check for damaged LED(s) and replace as necessaryWhat to do for Failure Mode: Temp too low--1. Ambient temperature may have been too cold to operate sensor.2. Check if film has damage, could indicate standing water insensor causing low temp error.What to do for Failure Mode: No CO2 Detected (Error code: Stage 5)--1. Try Calibrating and FAT testing the unit2. Remove Calibration Cartridge make sure fits easily and no leaks are heard.a. If leaks are heard inspect button and make sure Bird Precision fitting has Loctite on the Bird Precision fitting threads.3. Recalibrate sensor again with fresh cartridgea. If ChA voltage >3V check if film has been damaged (yellow)i. Swap out MUii. If voltage persists, go to step 6-8.4. Run a script to cycle the solenoids multiple times. Verify the movement of the solenoid can be felt.a. Perform on both solenoids individually to verify movementb. Perform on both solenoids together and verify movement5. In FsDiag observe the pressure increase when calibration gas is present is 3 to 6 torr higher than ambient6. Check plumbing for disconnected, pinched tubes, or debris in tubes.a. If debris -> blow out sensor recalibrateb. Broken solenoid port7. MU VAC check8. Attempt Calibrate with another MU9. Calibrate MU with another sensora. If MU can calibrate on another sensor and ChA voltage remains >3V implies this could be a firmware issue.What to do for Failure Mode: Low CO2 (Error code: Stage 6)--1. Try a new calibration cartridge2. Swap out the MU and verify sensor calibrates correctly3. Dismantle MU and examine the film for damagea. Replace film if damaged and retest4. Inspect MU O rings for wear and potential leaksWhat to do for Failure Mode: High CO2--Indicates a film error or a sensor electrical error.By looking at ChA voltage on either a serial log or during the FAT test you can examine:1. Attempt recalibration and rerun FAT test2. Check MU film for damage3. Swap out MU and attempt recalibration/FAT test.What to do for Failure Mode: Failed Room Air Validation--1. Move to location or create environment with as low ambient CO2 as possible and recalibrate2. Use FsDiag and observe the initial and final room air voltages during calibration(s)3. Check if Pump/Filter/Cannula are the newest modulesa. If not, replace them4. Is CO2 entering the system properly?a. If no, then if small CO2 waveforms are present, this indicates leaky solenoid (replace solenoids)b. If yes, check if tubing is pinched or disconnected or ifthere’s debrisi. Blow out sensor and recalibrate if air flow presentii. If there’s debris and it is rust, replace solenoids