Free O2 patient safety

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NA n and Weani ng A tio M a

FreeO2

Automated oxygen therapy ensuring patient safety

FreeO2

Oxygen therapy optimization is now possible with FreeO2

02 Source

02 Flow

Spo2 Target

Sp02

The FreeO2 device automatically adjusts the oxygen flow rate thereby maintaining an ideal oxygen target for maximum patient safety throughout the treatment period, while reducing potential side effects.

How it works FreeO2 controls a closed loop system that continuously adjusts the oxygen flow between 0 and 20 L/min in real time, (with or without a humidification system) based on the blood’s oxygen saturation (SpO 2).

The FreeO2 tailors oxygen therapy treatment to the patient’s needs, thereby reducing the risk of serious complications related to hypoxemia, including both hypoxia and hyperoxia.

Clinical recommendations can be delivered without complications for both the patient, and the attending personnel.

Features Real-time SpO2 monitoring Oxygen flow optimization Patient monitoring Alarms Plethysmography curve Heart Rate Respiratory Rate

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Medico-economic benefits

FreeO2 was designed and developed by clinicians aware of both the common and serious dangers of oxygen toxicity, and the inherent difficulties encountered by healthcare workers.

Safety and testing FreeO2 has been the subject of numerous successful studies and clinical validation trials on more than 500 patients in Canada and Europe.

FreeO2 Reduces patient’s length of stay by 29% In Days 15

-52%

-29% 9,9

10 7,1

5

0

• Clinical Benefits

• • • • • •

• The device-a technological pioneer-is dedicated entirely to automated oxygen therapy thereby reducing the effects of hypoxia and hyperoxia.

• Real-time monitoring and automatic counteractions to SpO2 fluctuations.

• Therapeutic data available for patient monitoring and trend observations.

• Physiological alarms for monitoring the clinical condition of the patient.

• Organizational Benefits

• • • • • • • •

• Optimizes multi-departmental oxygen therapy.

• Decreases patient length-of-stay by 29%.

• Minimizes overall oxygen consumption by about 50% thereby reducing costs.

• Reduces clinical interventions to assess patient SpO2.

• Easy to use, ensuring patient safety and increased staff confidence.

COPD exacerbation Lellouche 2016

Acute Resp Acute Resp Distress ED non Distress ED non COPD L’Her COPD L’Her 2017 2017

Pneumonia Carnot 2019

Freedom Lellouche 2019

Mean

Free02 Manual

Doubles the amount of time patient is in targeted SpO2 range and reduces oxygen consumption by 50%

• Patient Benefits

• • • •

• Recommended for the majority of patients who require oxygen as part of their treatment.

• Enhanced and individual oxygen therapy through treatment optimization.

• A safe device dedicated to the unique oxygen needs of every patient.

Time within the oxygenation target(%)

1 Lellouche F, Bouchard P, Roberge M, Simard S, L’Her E, Maltais F, LacasseY.Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. International Journal of COPD: 24 August 2016Volume 2016:11(1) Pages 1983—1990 2 L’Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N,Archambault P, Bouchard PA, Lellouche F.Automatic versus manual oxygen administration in the emergency department.. IEur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.

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3 Non-published datas: clinical trial n° NCT03396172 4 I Ouanes, F Bouhaouala, S Maatouk, M Lahmar, S Ben Abdallah, Z Hammouda, F Dachraoui, L Ouanes-Besbes, E L’Her, F Abroug.Automatic oxygen administration and weaning in patients following mechanical ventilation. J Crit Care . 2021 Feb;61:45-51. doi: 10.1016/j.jcrc.2020.10.005. Epub 2020 Oct 10

Oxygen consumption during the study (L)

87

43

120

240 5

Oxygen toxicity is systemic…

…which justifies the new practical guidelines for automating oxygen titration

FreeO2

The primary goal of oxygen therapy is to prevent hypoxia and hyperoxia.

The first goal: avoid hypoxia When SpO2 is less than 88%, tachycardia, myocardial ischemia, and arrhythmia events can occur.

For COPD patients, this increases pulmonary artery pressure and the subsequent death rate from associated complications.

The second goal: avoid hyperoxia

In 2017, the British Thoracic Society (BTS) published new guidelines8 regarding SpO2 targets to be maintained.

COPD patients Hypercapnic patients or at risk of hypercapnia

Target SpO2 88

92

General population

Target SpO2 90

94

The FreeO2 allows healthcare workers to apply clinical recommendations safely and confidently.

Patients are treated according to their particular needs, reducing the risk of complications related to hypoxia and hyperoxia.

8 O’Driscoll BR1, Howard LS1, Earis J1, MakV1. British Thoracic Society Guideline for oxygen use in adults in healthcare and emergency settings. BMJ Open Respir Res. 2017 May 15;4(1):e000170. doi: 10.1136/bmjresp-2016-000170. eCollection 2017.

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Notes

Technical data sheet

Description

FreeO2 is a device used for automated oxygen therapy. It can be used in a hospital environment by spontaneously breathing pediatric to adult patients requiring this type of treatment.

Indication

FreeO2 is an automated oxygen regulator designed to be used by trained personnel under the supervision of a physician in a clinical or hospital environment.Titrate oxygen flow. Maintain a clinician-defined target SpO2 level in spontaneously breathing patients over 1 month of age.

Performance

SpO2 reading: 70% to 100% ± 2 digits Heart rate: 40 to 240 bpm ± 5 digits O2 flow rate generated: 0 to 20 L/min, in increments of 0.1 Input pressure: 10 bar max.

Alarms (visible and audible) SpO2: min. and max.

Heart rate: min. and max.

Low battery Audible alarm reminder button High alarm sound level: 56 dB Low alarm sound level: 33 dB Alarm delay <5 sec.

Oxygen flow alarm

8

FreeO2

Electrical characteristics Main 100-240 VAC, 50-60 Hz DC input: 24 VDC, 1.33 A, AC adapter Power consumption: 15 W Batteries Type: Lithium ion Capacity: 3 hours Charging time: 4 hours

Environmental operating conditions

Operating temperature: 10°C to 40°C Operating humidity: 10% to 90% non-condensing Atmospheric pressure: 70 kPa to 106 kPa Storage temperature: -20°C to 70°C Storage humidity: 10% to 90% non-condensing

Device Classification (IEC 60601-1)

Type of protection: Class II (AC adapter, external power supply) Degree of protection: Type BF Applied Part Degree of protection of housing against water ingress with harmful effects: IP22 Operating mode: Continuous

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