Fitbit Zip Flow User manual

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Fitbit Flow User Manual
Version B
129-0575-01
May 2020

WARNING
The Fitbit Flow has not been FDA cleared or approved;
The Fitbit Flow has been authorized by FDA under an EUA;
The Fitbit Flow is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency use of
ventilators under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
Due to the rapid development cycle for this emergency use device, all efforts were made to
verify the software, but defects may still exist. The consequences of these defects are unknown
and may pose a risk to the patient.
For use only while FDA’s Emergency Use Authorization is in effect.
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Table of Contents
Glossary 6
Purpose of this manual 9
Safety Information 9
Definitions 9
General Warning Statements 9
Symbols and Markings 11
Fitbit Flow Overview 14
Indications for Use 14
Target Patients 14
Target Environment 14
Operational Use 14
Breathing Circuit 16
Respiratory Parameter Controls 17
Safety Features 17
Compatible Manual Ventilator 18
Tubing, Sensors, and Valves (outside enclosure) 18
Tubing, Sensors, and Valves (inside enclosure) 19
Risks and Benefits 19
Device Description 20
User Interface 20
Controls, Indicators, and Displays 20
Front Panel 22
Back Panel 23
Left Panel 24
Right Panel 25
For use only while FDA’s Emergency Use Authorization is in effect.
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Size and Weight 26
Environmental Conditions 26
Alarms and Troubleshooting 27
Alarm Level of Priority 27
Alarm Display 28
Silence Alarms 28
Alarm List 29
Additional Troubleshooting 30
Installation and Setup 31
Assemble the Stand 31
Components 31
Assembly Instructions 33
Assemble the Fitbit Flow Air Pathway System 35
Components 35
Assemble the Patient Circuit 39
Assemble the BVM Inside the Fitbit Flow 40
Power the Fitbit Flow 41
Operating Procedures 43
Turn On the Fitbit Flow 43
Start Ventilation 43
Ventilation Modes 43
Volume Control Mode 44
Pressure Control Mode 45
Assist Control 47
Inspiratory Hold 48
Stop Ventilation 49
Turn off the Fitbit Flow 49
For use only while FDA’s Emergency Use Authorization is in effect.
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Adjust Settings and Alarm Parameters 49
Cleaning and Maintenance 51
Cleaning the Fitbit Flow 51
Cleaning the Manual Resuscitator Bag 51
Replace Accessories 52
Specifications 52
Physical 52
Accuracy 53
Labeling Parameters 53
Electrical 54
Alarm Conditions 55
Appendix 57
A.1 FiO2 Flow and Minute Ventilation 57
Standards Compliance 58
General Standard 58
Particular Standards 58
User Assistance Information 59
Technical Support 59
Trademark Information 59
For use only while FDA’s Emergency Use Authorization is in effect.
5

Glossary
A
Acute respiratory distress syndrome (ARDS)
A life-threatening lung condition in which fluid enters the lungs, causing low blood oxygen
Assist control (AC)
An optional setting which provides support for patient-triggered breaths when enabled
B
Bag valve mask (BVM)
See Manual resuscitator.
D
Dual limb breathing circuit
Patient circuit with two tubes: one tube between the gas outlet and the patient for inspiratory gas, and one tube
between the patient and the exhalation block for exhalation gas
E
Endotracheal tube
A plastic tube that is placed through the patient’s mouth into the trachea
Expiratory tidal volume (VTe)
The volume of air moved out of the lungs in a breath
I
I:E ratio
The ratio of the inspiratory time as compared to the expiratory time
Inspiration time (IT)
The amount of time it takes to deliver air to the patient’s lungs
Inspiratory pressure (Pins)
The level of pressure applied to the lungs during the inspiration phase
Inspiratory tidal volume (VTi)
The volume of air moved into the lungs in a breath
For use only while FDA’s Emergency Use Authorization is in effect.
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M
Manual resuscitator
A bag used to provide positive pressure ventilation to patients who are not breathing. Also known as a bag valve
mask (BVM).
P
Patient-triggered breath
A breath initiated by the patient
Peak inspiratory pressure (PIP)
The highest pressure measured during the inspiration phase
Plateau Pressure (Pplt)
The pressure within the breathing circuit following an end-inspiratory pause
Positive end-expiratory pressure (PEEP)
Pressure that is applied by the ventilator at the end of the patient’s breath
Pressure (P)
The force of air applied per unit area
Pressure control mode (PCV)
A mode of ventilation in which a fixed pressure is applied during the inspiratory phase
R
Respiratory rate (RR)
The number of breaths per minute (bpm) a patient takes
T
Tidal volume (Vt)
The volume of gas delivered to the patient in one breath
U
Uninterruptible power supply (UPS)
A backup device that supplies electricity when the regular power source fails
For use only while FDA’s Emergency Use Authorization is in effect.
7

V
Volume control mode (VCV)
A mode of ventilation in which a fixed volume is applied during the inspiratory phase
For use only while FDA’s Emergency Use Authorization is in effect.
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Purpose of this manual
This user manual contains information on the safe and effective use, setup, and maintenance of
your Fitbit Flow. Before operating the Fitbit Flow, be sure to read and understand all the
instructions in this manual. The Fitbit Flow is intended for use by qualified, trained personnel
under the direction of a physician only when an FDA-cleared clinical ventilator is not available.
Safety Information
Definitions
This manual uses the following type of indicator to highlight critical information:
WARNING
WARNING indicators describe potentially hazardous conditions that could
result in death or serious injury.
General Warning Statements
● Use only as directed. Review the User Manual completely before use. Improper
usage or unauthorized modification of this product may result in user or patient
injury.
● The use of a UPS (Uninterruptible Power Supply) designed for a clinical setting is
mandatory as loss of power may result in patient injury or death.
● The UPS connected to the Fitbit Flow should be equipped with an alarm to alert
the operator when power is switched to battery power. The UPS should also
indicate how much battery power and/or time remains.
● The system does not have the capability to sound an alarm due to a power outage
to the system. If the power source is interrupted, the system will revert to the
default settings when power is restored. The operator will need to change any
desired settings and restart ventilation.
● Clinical monitoring (e.g. SpO2with finger pulse oximetry and arterial blood gases)
should be conducted to make sure the patient is achieving adequate oxygenation.
The Fitbit Flow does not directly measure the %FiO2delivered to the patient, and
one should not assume that the delivered %FiO2is equal to the %O2of the source.
● The Fitbit Flow has not been tested for electromagnetic compatibility (EMC). It
may produce electromagnetic disturbances that will affect the performance of
other equipment. It may fail to perform as expected in the presence of
electromagnetic disturbances from other equipment.
For use only while FDA’s Emergency Use Authorization is in effect.
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● The Fitbit Flow has not been tested for MRI scanner compatibility and should not
be used in the vicinity of an MRI scanner.
● Do not pull on the oxygen tube. Doing so could dislodge or otherwise move the
manual resuscitator within the enclosure.
● The Fitbit Flow has been tested for 24 hours of continuous use. If using longer
than 24 hours, check for signs of wear and tear, particularly on the manual
resuscitator.
● The Fitbit Flow has not been characterized under leakage test conditions. If there
is significant patient circuit leakage, the device may under-deliver tidal volume to
the patient.
● Provide sufficient space around the Fitbit Flow for adequate air flow. Do not
position next to objects that may block the flow of air. Failure to do so may cause
the equipment to overheat, thereby interfering with patient ventilation.
● Do not block the gas intake port or emergency intake port. This may interfere with
patient ventilation.
● Do not add any attachments or accessories to the Fitbit Flow that contravene the
instructions for use of the Fitbit Flow, as the Fitbit Flow might not function
correctly, leading to the risk of patient death or serious deterioration of health.
● The Fitbit Flow shall not be used in a hyperbaric chamber. Such use might cause
the Fitbit Flow to not function correctly, causing patient death or serious
deterioration of health.
● The Fitbit Flow does not support the delivery of gas anesthesia agents, and is not
intended for use with such medications. Such use might cause the Fitbit Flow to
not function correctly, causing patient death or serious deterioration of health.
● The Fitbit Flow shall not be used with inlet gases other than medical air or oxygen,
which are not specified for use (e.g. helium or mixtures with helium). Such use
might cause the Fitbit Flow to not function correctly, causing patient death or
serious deterioration of health.
● It is the responsibility of the clinician to ensure that the oxygen source is
appropriately selected with respect to the range of pressure, flow rate and oxygen
concentration.
● Breathing system filters and heat and moisture exchangers may require more
frequent replacement to prevent increased resistance and blockage.
● When moving the Fitbit Flow, disconnect it from the patient and turn off the
device.
● Lock the stand’s caster wheels whenever the Fitbit Flow is in use.
● Do not attempt to move the Fitbit Flow when it is connected to a patient.
● Do not cover or obstruct the alarm button. The operator must be able to see the
alarm button when the device is connected to the patient, particularly in noisy
environments where the operator may not hear the alarm.
● Frequent alarms are possible. When an alarm is triggered, always check the cause
and respond accordingly. Failure to respond to alarms can result in serious harm
or death.
● Failure to follow the cleaning and maintenance instructions could result in
equipment damage and potentially harm the patient.
● Do not attempt to clean or re-use single use accessories.
● Do not reuse single-use components. Doing so increases the risk of
cross-contaminations between patients.
For use only while FDA’s Emergency Use Authorization is in effect.
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