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.
2

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.
3

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.
4

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.
6

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.
8

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.
9

● 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.
10

● When operating in PCV (Pressure Control Mode) the Fitbit Flow may not achieve a
constant pressure throughout the entire inspiratory period, which may reduce the
delivered tidal volume.
● When Assist Control is enabled, it is important to monitor for breath stacking (also
called breath dyssynchrony stacking), which can result in unintended high tidal
volumes as a consequence of incomplete exhalation between consecutive cycles.
Continuous CO2monitoring (also called capnography) and arterial blood gas
sampling should be conducted to detect high CO2levels which may be a
consequence of hypoventilation.
● In some patients, especially those with abnormal lung compliance, an inspiratory
hold of one second may not be long enough for the pressure to equilibrate in the
lungs. In such cases, the reported plateau pressure will not be accurate.
Federal law restricts this device to sale by or on the order of a Physician.
For use only while FDA’s Emergency Use Authorization is in effect.
11

Symbols and Markings
Symbol
Meaning
This symbol appears in the user manual.
It is essential to read, understand, and follow these instructions or warnings before
using the Fitbit Flow.
This symbol appears in the Fitbit Flow box.
Pinch point. Keep hands and fingers clear during operation.
This symbol appears on the Fitbit Flow’s back panel.
It signifies where the AC connector cable is located.
This symbol appears on the Fitbit Flow’s back panel in two locations: the holes
where the external display attachment should be screwed in, and above the HDMI
and USB connections.
It signifies where to connect the optional external display.
This symbol appears on the Fitbit Flow’s back panel above a USB connection.
It signifies where to connect to the Fitbit Flow in order to service it.
This symbol appears on the control panel’s alarm button.
It is used to display alarm details and silence an active alarm.
This symbol appears on the control panel’s up button.
It is used to scroll up through menu items or increase a parameter value.
This symbol appears on the control panel’s down button.
It is used to scroll down through menu items or decrease a parameter value.
This symbol appears on the control panel’s back button.
It is used to return to the previous menu.
This symbol appears on the control panel’s confirm button.
It is used to accept a new setting.
For use only while FDA’s Emergency Use Authorization is in effect.
12

This symbol appears on the control panel’s start/stop button.
It is used to start or stop ventilation.
For use only while FDA’s Emergency Use Authorization is in effect.
13

Fitbit Flow Overview
Indications for Use
The Fitbit Flow is indicated for the continuous mechanical ventilatory support of adult patients.
The Fitbit Flow is an accessory to a manual resuscitator and consists of a reusable mechanical
actuator and the single-use, disposable tubing assembly. The Fitbit Flow supports conventional
Volume Control and Pressure Control modes of ventilation, as well as an “Assist Control” feature
to support breaths triggered by the patient. 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 during the COVID-19 pandemic.
Target Patients
The Fitbit Flow is intended for adult patients who require the following types of invasive or
non-invasive ventilatory support, as prescribed by an attending physician:
● Positive Pressure ventilation
● Breath types including Volume Control and Pressure Control
● Assist/Control
The Fitbit Flow is applicable to patients with severe respiratory symptoms, including those with
Acute Respiratory Distress Syndrome (ARDS), who require respiratory support.
Target Environment
The Fitbit Flow is intended for use in hospitals and hospital-type facilities (including field
hospitals), that provide care for patients requiring respiratory support.
The Fitbit Flow is not intended for home use. The Fitbit Flow must be operated by respiratory
therapists, doctors, or nurses. The Fitbit Flow should only be used on adult patients when an
FDA-cleared clinical ventilator is not available.
Operational Use
The Fitbit Flow is designed to provide continuous ventilation through automated activation of an
FDA-cleared manual resuscitator (also called bag valve mask (BVM)). The system consists of
the box and a dual-limb breathing circuit attached to the patient, shown in Figure 1.
For use only while FDA’s Emergency Use Authorization is in effect.
14

Figure 1: System Diagram
For use only while FDA’s Emergency Use Authorization is in effect.
15

The Fitbit Flow should only be used on adult patients and when an FDA-cleared clinical
ventilator is not available. The Fitbit Flow is designed to provide continuous mechanical
ventilation to the patient.
Ventilation modes include a volume control mode (VCV) and a pressure control mode (PCV). An
optional Assist Control setting provides support for patient-triggered breaths when enabled.
Enabling Assist Control allows the software to automatically detect when the patient is
attempting to trigger spontaneous breaths in between ventilator cycles, by sensing the pressure
below the positive end-expiratory pressure (PEEP) on the inspiration limb. When a
patient-triggered breath is sensed, the Fitbit Flow will provide support for that breath to achieve
the target volume or pressure. When Assist Control is disabled, the respiratory rate is entirely
determined by the ventilator rate setting.
Breathing Circuit
The medical gas source is connected to the box and the gas flows through the resuscitator bag
within the box (see Figure 2) into the standard breathing circuit tubing outside of the box and
into the patient’s airway through a standard endotracheal tube.
Figure 2: Internal Air Pathway
The Fitbit Flow connects to a medical gas source through the manual resuscitator bag or the
reservoir bag, as per the indications of use of the manual resuscitator. The Fitbit Flow accessory
uses motorized arms to automatically compress a resuscitator bag (see Figure 3).
For use only while FDA’s Emergency Use Authorization is in effect.
16

Figure 3: Compression Mechanism
Respiratory Parameter Controls
Controls are provided for setting respiratory parameters:
● Respiratory Rate (RR)
● Inspiratory:Expiratory ratio (I:E)
● Tidal Volume (Vt)
● Inspiratory Pressure (P)
PEEP is set by a compatible manual valve made by the resuscitator or ventilatory accessory
manufacturer.
Safety Features
The Fitbit Flow accessory has a pressure sensor at the patient connection and flow sensors on
the inspiratory path and expiratory path for monitoring and feedback control. These pressure
and flow sensors connect to standard ventilator tubing connectors, as listed below. There are
hardware pressure valves which limit the pressure in either limb to 1 PSI (70 cmH2O). There is
also a pressure-limiting valve, which is an optional part available for the resuscitator bag, that
limits the pressure to 40 cmH2O (typical). In addition, you can set software limits that trigger
audible alarms for pressure and flow values. For more information on alarms, see Alarms and
Troubleshooting.
For use only while FDA’s Emergency Use Authorization is in effect.
17

Compatible Manual Ventilator
Part
Supplier
Part
Ambu SPUR II Adult
Resuscitator
Ambu
Ambu Spur II
Tubing, Sensors, and Valves (outside enclosure)
Part
Supplier
Part
Quantity
Heat Moisture Exchange (HME) plus virus filter,
22 mm connector
Hsiner
70531
1
Virus filter, 22OD/22ID connector
Hsiner
70530
2
PEEP Valve, 30 mm ID, manual adjustable
5-20cm H2O
Hsiner
60019
1
Non Rebreathing Valve (NRV or patient valve)
with 60cm H2O pop off valve and expiratory
diverter for PEEP connection, 30 mm OD
Hsiner
60031
1
Tubing Adapter 22 mm ID x 30 mm OD
Hsiner
70080
1
Adapter 30mm ID x 22 mm OD
Hsiner
70065
1
Corrugated Tubing 22 mm ID - cut to 60 inch
segment
Hsiner
70204
1
Corrugated Tubing 22 mm ID - cut to 30 inch
segment
Hsiner
70202
2
Pressure line adapter, 22mm OD x 22mm ID, for
4-6 mm ID pressure tubing
Hsiner
70084
1
Flexible tubing for air, fits pressure sensor
adapter, 3/16” ID, 60 inch long
Saint Gobain
ADF00012
1
Water Trap, 22M, Adult, disposable
Hsiner
70520
1
Catheter mount adapter, 22Fx22M15F,
disposable
Hsiner
70130 or
70131
1
For use only while FDA’s Emergency Use Authorization is in effect.
18

Tubing, Sensors, and Valves (inside enclosure)
Part
Supplier
Part
Quantity
Digital Flow sensor
Sensirion
SFM3019
2
Digital flow sensor cable (to MB)
Sensirion IAC
6017A0254301
2
Pressure line adapter, 22mm OD x 22mm ID, for
5-7 mm ID pressure tubing
Teleflex
1642
2
Tubing Adapter 22 mm OD x 22 mm OD
Hsiner
70019
3
Elbow adapter 22mm ID - 22mm OD
Teleflex
1641
1
Corrugated Tubing 22 mm ID - cut to 18 inch
segment
Hsiner
70226
1
Corrugated Tubing 22 mm ID - cut to 6 inch
segment
Hsiner
70201
1
Corrugated Tubing 22 mm ID - cut to 12 inch
segment
Hsiner
70231
1
Corrugated Tubing 22 mm ID - cut to 6 inch
segment
Hsiner
70201
1
Flexible tubing for air, fits pressure sensor
adapter, 3/16”ID, 30 inch long
Saint Gobain
ADF00012
3
Flexible tubing for air, fits pressure sensor port
(1.9 mm OD), 1/16" ID, 12 inch long
Saint Gobain
ADF00002
3
Eldon James 1/4-18 NPSM to 3/16" x 3/16"
Barbed Bulkhead Adapter
Eldon James
BH4S-3-3-200
NK
1
Tight-Seal Moisture-Resistant Barbed Tube
Fitting
Plastic, for Air and Water, Reducer, 3/16" x 1/16"
Tube ID
Eldon James
C3-1-200NK-Q
C
3
Risks and Benefits
The benefits for the use of the Fitbit Flow have been reviewed against the risks of use and have
found to outweigh the risks of use during the COVID-19 health emergency.
For use only while FDA’s Emergency Use Authorization is in effect.
19

Device Description
User Interface
The user interface consists of an LCD panel and control buttons and knobs on the front of the
box. The LCD screen displays values from the system sensors, as well as mode and alarm
settings. Settings may be selected and adjusted with the buttons and knobs as described below
(Figure 4).
Controls, Indicators, and Displays
Figure 4: User Interface
For use only while FDA’s Emergency Use Authorization is in effect.
20