OxyNov FreeO2 User manual

FreeO2
Automated Oxygen Therapy Device
User Manual
Models:
FO2-110-00, adult and pediatric - STD

Copyright © 2021 OxyNov
User Manual, FO2-OMP-02 (English)
Version 3.4, 2021-05

Table of Contents
Page iii
TableofContents
1 Typographic Conventions, Alerts, and Symbols ..............................................................1
1.1 Typographic Conventions ..........................................................................................................................1
1.2 Alerts ...................................................................................................................................................................1
1.3 Symbols ..............................................................................................................................................................2
2 Indications for Use .......................................................................................................................3
2.1 Indications ........................................................................................................................................................3
2.2 Contraindications ..........................................................................................................................................3
3 Description ......................................................................................................................................5
4 Installation ......................................................................................................................................9
4.1 Installing the FreeO2....................................................................................................................................9
4.2 Startup .............................................................................................................................................................12
4.3 Shutdown .......................................................................................................................................................14
4.4 Changing the Oxygen Source During Treatment ..........................................................................14
4.5 Description of icons ...................................................................................................................................14
5 Oximeter Warnings and Cautions ......................................................................................17
5.1 Oximeter Warnings ...................................................................................................................................17
5.2 Oximeter Cautions .....................................................................................................................................17
6 Operation ......................................................................................................................................19
6.1 Selecting a Patient ......................................................................................................................................19
6.2 Continuing the Treatment ......................................................................................................................20
6.3 Monitoring .....................................................................................................................................................21
6.4 Treatment ......................................................................................................................................................22
6.5 Alarms .............................................................................................................................................................25
6.6 Trend Measurement ..................................................................................................................................29
6.7 Configuration ...............................................................................................................................................30
6.8 Screen Locking .............................................................................................................................................34
7 Electromagnetic Emissions and Immunity ....................................................................35
7.1 Electromagnetic Emissions ....................................................................................................................35
7.2 Electromagnetic Immunity ....................................................................................................................37
7.3 Distances between RF Communication Equipment and the FreeO2....................................39
8 Maintenance ................................................................................................................................41
8.1 Cleaning ..........................................................................................................................................................41
8.2 Calibration .....................................................................................................................................................41
8.3 SpO2Testing .................................................................................................................................................42
8.4 Batteries .........................................................................................................................................................42
9 Warranty and Contact .............................................................................................................45
9.1 Warranty ........................................................................................................................................................45
9.2 Contact ............................................................................................................................................................46

Page iv
Table of Contents
9.3 Training ..........................................................................................................................................................46
Appendix A Specifications ..........................................................................................................47
Appendix A.1 FreeO2..........................................................................................................................................47
Appendix A.2 FreeO2Response Time .........................................................................................................49
Appendix A.3 Example of the SpO2Exponential Averaging..............................................................49
Appendix A.4 Default Values and Limits....................................................................................................50
Appendix A.5 SpO2Sensors.............................................................................................................................53
Appendix A.6 Power Supply............................................................................................................................53
Appendix B Testing Summary ..................................................................................................55
Appendix B.1 SpO2Accuracy Testing..........................................................................................................55
Appendix B.2 Heart Rate Motion Testing..................................................................................................55
Appendix B.3 Low Perfusion Testing..........................................................................................................55
Appendix B.4 Test Results ...............................................................................................................................55

Typographic Conventions, Alerts, and Symbols
Page 1
1TypographicConventions,Alerts,andSymbols
This chapter presents the conventions used to present information as well as the warning symbols.
1.1TypographicConventions
In a procedure, the steps that the user must follow are numbered 1, 2, 3 ... Lower case letters (a, b, c ...) are
used to indicate substeps for a complex procedure.
Small capitals are used to identify a term marked on the unit, such as connector names, buttons, indicator
lights, etc.
All terms used in the software interface, such as command names and text boxes are in bold.
1.2Alerts
This section presents the alert symbols and words that indicate critical information to be aware of before
using the FreeO2.
IMPORTANT: Indicates information that should be taken into consideration.
NOTE: Indicates additional information about using FreeO2.
Warning
Indicates that you must be extremely careful when executing these
instructions. Not complying with these warnings can cause serious injury or
even death.
Caution
Indicates that you must be careful when executing these instructions. Not
complying with these caution directives can cause minor injury or equipment
damage.

Page 2
Typographic Conventions, Alerts, and Symbols
1.3Symbols
This section presents the symbols used with regard to this medical device.
Symbol Label Symbol Label
Manufacturer
Manufacturing date
Oxygen
Authorized representative in
the European Community
CE mark (made in compliance with
93/42EEC Directive on class IIA or
IIB medical devices)
Serial number Refer to the instruction manual or
booklet
Catalogue number Non-ionizing electromagnetic
radiation
Quantity DC power
Medical Device Not for general waste
Unique Device Identifier Do not use if the package is
damaged
Type BF applied part Bell, temporarily canceled
Temperature limits USB connection

Indications for Use
Page 3
2IndicationsforUse
The FreeO2Automated Oxygen Therapy Device provides oxygen therapy on demand, based on continuous,
non-invasive monitoring of oxygen saturation.
The FreeO2Automated Oxygen Therapy Device is intended to deliver a titrated (self-adjusting) flow of oxygen
to maintain the patients within predetermined oxygen saturation levels, as set by the user and monitored by
the system via an oximeter.
The FreeO2Automated Oxygen Therapy Device is indicated for use under the direction of a physician in a
clinical or hospital environment, on spontaneously breathing pediatric, and adult patients who are prescribed
supplemental oxygen via a nasal cannula or oxygen mask.
This chapter presents the indications and contraindications for using the FreeO2.
2.1Indications
The FreeO2device is an automated oxygen regulator intended to be:
•Operated by trained personnel.
•Used under the direction of a physician in a clinical or hospital setting.
•Used to titrate the oxygen flow.
•Used to maintain a target SpO2level, set by clinicians, for spontaneously breathing patients older
than 1 month.
2.2Contraindications
•The FreeO2device is not intended to be used simultaneously on multiple patients.
•Do not use the FreeO2on a patient:
That is less than 1 month old.
For whom the SpO2is not stable.
With CO poisoning.
That is not spontaneously breathing.
Who is incapable to keep airways clear or free of secretions.
NOTE: For additional contraindication, warning, and caution indications, refer to the applicable sensor
instructions for use.

Page 4
Indications for Use

Description
Page 5
3Description
This chapter presents the components of the FreeO2.
The FreeO2is an automated oxygen regulator intended to be operated by trained personnel, under the
direction of a physician in a clinical or hospital environment, to titrate the oxygen flow, based on a pulse
oximetry signal, and to maintain a target SpO2level on spontaneously breathing patients.
It automatically delivers, through standard devices (nasal cannula, face mask), the necessary oxygen flow rate
according to the oxygenation level defined by the clinician and the dynamic response of each patient type.
It works in a closed loop and adapts, every seconds, the oxygen flow rate administered, between 0 and
20 l/min in increments of 0.1 l/min, according to the values read of the oxygen saturation (SpO2) in the blood,
provided by a pulse oximeter installed on the patient.
IMPORTANT: The FreeO2may only be used by trained personnel, according to directions of a physician,
and only for patients that are spontaneously breathing.
Figure 3-1 presents the components of the FreeO2front and back panels.
Figure 3-1 Front panel (left) and back panel (right)
Bolus mode (see Figure 3-1 left)
The bolus mode administers a fixed oxygen flow rate for 2 minutes then returns to the mode previously
selected either: FreeO2, CONSTANT FLOW, or ACQUISITION. Press the yellow button "Bolus mode" to activate
it. It is possible to deactivate the Bolus mode before the end of the 2 minutes, by pressing the button again.
Start/stop
button
Touch
screen
Network
connection
2.0 USB
port
Electric power
connector
Oximeter
connector
Bolus mode
Connection reserved
for the use of
OxyNov
Indicator light
of the oxygen
bolus mode
activation
Indicator light
of the power
and battery
levels
Alarm indicator light
Snooze
button
Oxygen output
(to patient)
Oxygen
input

Page 6
Description
This mode is used when a quick oxygen boost is needed without having to reconfigure the FreeO2.
Oxygen flow rate:
•Pediatric, 5 L/min
•Adult, 10 L/min
NOTE: If no patient type is selected, Bolus mode is 2 L/min.
Indicator light of the power and battery level (see Figure 3-1 right)
The indicator light of the power and battery levels is green when the unit is connected to a power source and
the batteries are fully charged. While charging, the indicator is yellow. When the unit is used with the
batteries, the indicator is off. In addition, when the unit is operating on batteries, the indication "BATTERY-
OPERATED" appears on the monitoring screen (Figure 3-3).
When the indicator light flashes yellow, it indicates a potential problem with the batteries. Check the battery
icon on the screen (Figure 4-8) and if the screen does not represent a full battery even though the equipment
has been plugged into the wall for at least 5 hours, this indicates that the batteries might need to be changed
and the FreeO2 device should be sent to an authorized service center for evaluation.
Snooze button (see Figure 3-1 left)
During an alarm, tapping this button stops the alarm for a period of 2 minutes after which the alarm restarts.
If you tap the button before the end of the 2-minute period, the alarm restarts.
Figure 3-2 presents the components of the FreeO2left and right panels.
Figure 3-2 Left side (left) and right side (right)
Oxygen outputOxygen input