SLE6000 OxyGenie User Guide sw ver 2.0.40 onwards

Useful References Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology 2014;105:55–63. Poets CF, Roberts RS, Schmidt B, et al. Association between intermittent hypoxemia or bradycardia and late death or disability in extremely preterm infants. JAMA 2015;314:595–603. Plottier GK, Wheeler KI, Ali SKM, Sadeghi Fathabadi O, Jayakar R, Gale TJ, Dargaville PA. Clinical evaluation of a novel adaptive algorithm for automated control of oxygen therapy in preterm infants on non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed 2017; 102: F37-F43. Peter A Dargaville, Omid Sadeghi Fathabadi, Gemma K Plottier, Kathleen Lim, Kevin I Wheeler, Rohan Jayakar, Timothy J Gale Development and preclinical testing of an adaptive algorithm for automated control of inspired oxygen in the preterm infant Arch Dis Child Fetal Neonatal Ed 2016;0:F1–F6. Clarke, A., Yeomans, E., Elsayed, K., Medhurst, A., Berger, P., Skuza, E. and Tan, K. (2015) A randomised crossover trial of clinical algorithm for oxygen saturation targeting in preterm infants with frequent desaturation episodes. Neonatology, 107 (2), 130-136.

This booklet is designed to act as a guide to using OxyGenie®. It is not intended to replace formal training or the User Manual. All operators of the SLE6000 must be trained and competent in the use of the SLE6000. All data correct at time of publication. Specifications relevant to software version V 2.0.40 onwards, however some software versions may differ.

OxyGenie® OxyGenie® is a system intended to control the inspired oxygen delivery to keep the patient’s SpO2 within a predefined target range. OxyGenie can be used during mechanical ventilation, nCPAP, non-invasive respiratory support and High Flow Oxygen Therapy when administered to neonatal, infant and paediatric patients.

Contents Required equipment... 4 How to get a proper SpO2 reading... 4

Warnings and Cautions... 4 Using OxyGenie... 5 1. Turning on SpO2 monitoring... 5

2. Preparing for OxyGenie... 6

3. Turning on OxyGenie... 6

Turning off OxyGenie... 7 Monitoring... 8

Reference O2... 9

Manual Override... 9

Loss or low SpO2 signal. Fall-back mode... 10

Delta FiO2 max... 11

If FiO2 goes higher than FiO2 upper alarm set in alarm panel?... 12 Suction/disconnect patient?... 12

Set FiO2 may be different to monitored FiO2?... 12

Alarms linked to SpO2 monitoring... 13

OxyGenie alarm messages ... 15

SpO2 sensor alarm messages... 16 What can affect SpO2 measurements?... 18

How it works Developed at the University of Tasmania, in collaboration with the Royal Hobart Hospital, the OxyGenie® software module uses a Proportional/Integral/ Derivative algorithm which makes it responsive to SpO2 deviations, allowing it to recognise serious instability and then be able to safely and quickly counteract it. OxyGenie® can make adjustments to the SLE6000’s FiO2 every second. OxyGenie® also calculates the average amount of oxygen required to keep the patient within the target range. This is calculated using the previous hour’s data and this value is called the “Reference O2”. The Reference O2 is recalculated every 30 minutes.

Required equipment • • • • •

Implementation of SLE6000 OxyGenie® software on your SLE6000 Implementation of SLE6000 SpO2 software SLE uSpO2 cable (Masimo SET®) Masimo LNC SpO2 adhesive sensor (to suit patient) An RD to LNC adaptor cable (Part number: LSPO2/4089) is required to use Masimo RD Neonatal adhesive sensors.

How to get a proper SpO2 reading

As OxyGenie relies on SpO2 monitoring to adjust FiO2, it is essential to get reliable readings of SpO2. Masimo SET technology has a quality index monitoring the SpO2 signal continuously.

Warnings and Cautions: • • • •

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If the difference between SpO2 and SaO2 is greater than 5% OxyGenie is not recommended since the SpO2 may not accurately reflect the patient’s PaO2.

An increasing requirement for oxygen while using OxyGenie may be indicative of an underlying condition which has to be addressed, even if the SpO2 is within the target range. OxyGenie does not replace the need to analyse blood samples and should be performed on a regular basis for monitoring the patient’s condition.

Use of OxyGenie is contraindicated on patients whose target SpO2 is outside the following target ranges. 90-94%, 91-95%, 92-96%, 94-98%.

Read the User Manual for more information.

Using OxyGenie®: 1. Turning on SpO2 monitoring 1. Ensure SpO2 module is active and plugged in 2. Select Utilities button 3. Select SpO2 sub-menu 4. SpO2 switch...turn on (if not on).

SpO2 averaging time is automatically set at 2-4 seconds.

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Delay between time where the upper/lower SpO2 or upper FiO2 set alarms threshold are reached and the audible alarm sounds.

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Rapid Desat: Auto default set at 10%

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Select a target range suitable for the patient.

Utilities button > Sensors tab > SpO2 button >

5. Choose a suitable target range for the patient. • • • •

90% -94% 91% - 95% (Default) 92% - 96% 94% - 98%

The target range can be changed at any time. When OxyGenie is activated; High SpO2 alarm threshold is automatically set to the high SpO2 limit + 1% Low SpO2 alarm threshold is automatically set to the low SpO2 limit -1% For alarms, please refer to page 13. Alarms appropriate to the patient should be set manually.

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Using OxyGenie®: 2. Preparing for OxyGenie® First, manually set the FiO2 to achieve an SpO2 within the desired SpO2 target range, and then turn on OxyGenie. This allows for the optimal response from OxyGenie.

Using OxyGenie®: 3. Turning on OxyGenie® Be aware that the Max FiO2 that can be set on start up is 60%, within one second OxyGenie recalculates and changes FiO2 if the patient is outside the target range. OxyGenie is not available when SpO2 monitoring is off.

1. Press until OxyGenie control appears

a. Select the OxyGenie button

2.

b. Press confirm button �

OxyGenie is activated

The FiO2 that was set before turning on OxyGenie becomes the Reference O2

3. The concentration of O2 will now be automatically controlled to maintain the midpoint of the target SpO2 range.

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Turning off OxyGenie® 1. Press and hold the O2 parameter button until the OxyGenie control appears.

2.

OxyGenie button (Press to Disable) is activated,

Press confirm button.

The O2 parameter control returns to manual adjustment, using the last Reference O2.

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Monitoring To view the OxyGenie data you should select the SpO2 screen in the layout menu.

SpO2 view is available in Layout Select here to edit screen contents

Layout button >

Select to confirm

Layout button > Edit

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Current FiO2 PI: Perfusion Index PR: Pulse rate Singal Indicator Quality (SIQ) SpO2 targeted range Reference O2 High FiO2 alarm threshold Patient’s current SpO2

SpO2 layout screen

OxyGenie is ON and in AUTO mode Delivered FiO2

OxyGenie is ON

SpO2 target range

Reference O2 The displayed Reference O2 shows the average FiO2 used during the last hour to keep the SpO2 within the SpO2 Target Range. It is updated every 30 minutes. The Reference O2 is an indicator of the severity of lung disease. OxyGenie takes into account the Reference O2 when adjusting the FiO2 since the same increase in FiO2 will have a different effect in a lung with a low FiO2 requirement compared with a lung with a high FiO2 requirement. OxyGenie limits any increase in FiO2 to the Reference O2+40%.

Manual Override To modify the FiO2 concentration: Manually press the O2 button.

Text “Auto” will be replaced by three dashes. Adjust the O2% to the required percentage by pressing the plus/minus buttons. On pressing the confirm button the 30 second manual override will start. 9

Message box turns blue and displays “Manual Override” with the remaining time (in 30 seconds).

Each manual override counts down from 30s. OxyGenie then recalculates and readjusts the FiO2 every second to maintain the patient within the desired SpO2 target, starting from: • The FiO2 used during the override if FiO2 during the override is lower than or equal to Reference FiO2 + 40% • The Reference FiO2 + 40% if FiO2 during the override was higher than or equal to Ref FiO2 + 40%

Loss or low SpO2 signal. Fall-back mode.

Two dashes in the SpO2 value and three dashes in the O2 parameter button are shown with “Waiting for Signal in the status indicator.

1. During the first 60 seconds of no valid SpO2 signal, OxyGenie delivers the last O2 setting. 2. After 60 seconds of no valid SpO2 signal: • If the last valid SpO2 reading was within the target range OxyGenie continues to deliver the last set FiO2 value. • If the last valid SpO2 reading was above the target range and FiO2 was more than 10% above the reference FiO2, OxyGenie will slowly decrease the delivered oxygen towards the reference O2 value. • If the last valid SpO2 reading was below the target range and FiO2 was more than 5% below the reference FiO2 OxyGenie will slowly increase the delivered oxygen towards the reference O2 value As soon as a valid SpO2 signal is detected OxyGenie will calculate and set the FiO2 based on that SpO2 value. 10

Alarms and Notifications Delta FiO2 max. OxyGenie will not increase FiO2 to more than 40% above the Reference O2 to avoid large fluctuations in delivered oxygen.

If an increase of FiO2 of more than 40% above the Reference O2 is required to maintain patient within SpO2 target, OxyGenie will give the message “∆FiO2 Max” and “Low SpO2” alarm will appear if the target is not reached. The ventilator will not increase FiO2 any further. It is important to re-assess the condition of the patient if the delta O2 requirement has changed drastically. Check SpO2 monitoring, selective intubation, extubation, as well as underlying conditions such as; lung collapse, pneumothorax and haemodynamic problems to identify possible causes. If the change of patient condition is transitory (post suctioning,...), FiO2 can be increased by manually overriding FiO2. The override lasts for 30s. If the deterioration of the patient’s condition is expected to last for a longer time and their new required FiO2 is above FiO2 Ref + 40%, then a new FiO2 reference should be entered by following these steps; 1. Turn off OxyGenie 2. Enter the new required FiO2 3. Turn OxyGenie back on The new FiO2 becomes the new Ref SpO2; however keep in mind that it cannot be set above 60% but OxyGenie is very reactive and can adjust the FiO2 up to 100%.

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If FiO2 goes higher than FiO2 upper alarm set in alarm panel? “O2 over set limit” alarm is triggered. It doesn’t prevent OxyGenie from using higher FiO2 than the set High FiO2 alarm: it is just an alert

Exceeded alarm limit Current delivered FiO2

Alarms button > Limits tab

Suction/disconnect patient? No specific action, ventilator controls FiO2 related to SpO2.

Set FiO2 may be different to monitored FiO2?

The set FiO2 is the desired FiO2, but there is a small delay between updating the screen FiO2 by the oxygen cell.

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Alarms linked to SpO2 monitoring 1. “High and low SpO2” 2

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3

Alarms button > Limits tab > SpO2

These are automatically set at • +1 % above the upper limit of the selected target • -1 % below the lower upper limit of the selected target They can be modified manually to reflect the patient’s condition.

2. “Alarm Delay” 2 1 3

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Utilities button > Sensors tab > SpO2 button > Alarm delay

Alarm delay: Delay between time when the upper/lower SpO2 set alarm thresholds are reached, and the audible alarm is triggered.

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3. “Rapid Desat” alarm

It allows the clinician to override the audible alarm delay when the SpO2 value exceeds the alarm limit threshold set by the user by more than 5% or 10%. It can be disabled. 2

PTV

1 3

4

Utilities button > Sensors tab > SpO2 button > Alarm Delay

4. “FiO2 high” alarm

The user can set a delivered oxygen level above which they want to be notified (default of 60%), alarm delay is the same as SpO2 alarm delay. It is a visual and audible alarm but doesn’t prevent OxyGenie from using a higher FiO2 than the alarm threshold.

Alarms button > Limits tab > O2

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OxyGenie® alarm messages

Alarms button > Limits tab > O2

1. “O2 over set limit”

When OxyGenie® is active the user can set an FiO2 above which they want to be notified (default of 60). Alarm delay is the same as SpO2 alarm delay. Action: Check patient for change of underlying condition causing increased requirement for oxygen. Consider adjusting ventilator parameters. Check patient circuit for leak.

2. “Low SpO2”

When SpO2 drops below the set low SpO2 alarm threshold. The alarm delay applies. If rapid Desat Alarm is on, It overrides the audible alarm delay when the SpO2 value exceeds by 5% or 10% the alarm limit threshold set by the user. Action: Check patient’s FiO2 is adequate. Consider adjusting ventilator parameters.

3. “OxyGenie is not available”

Technical problem of communication with PCLC Action: OxyGenie is not available so manual titration/adjustment of oxygen is required. Route ventilator for repair when convenient.

4. “OxyGenie Unexpected reset”

Previous problem has resolved. OxyGenie® is now available. Before re-initiating OxyGenie®, set the O2 setting regarding the patient’s current clinical condition to ensure that the control algorithm responds appropriately.

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SpO2 sensor alarm messages 1. “No SpO2 Module Connected”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Connect SpO2 module, cable and sensor or turn OFF SpO2 monitoring

2. “No SpO2 Sensor Connected”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Connect SpO2 sensor or turn OFF SpO2 monitoring

3. “No SpO2 Cable Connected”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Connect SpO2 cable and sensor or turn OFF SpO2 monitoring

4. “No Adhesive SpO2 Sensor Connected”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Connect SpO2 adhesive sensor or turn OFF SpO2 monitoring. Action: Whenever SpO2 monitoring is turned off, OxyGenie is automatically disabled.

5. “Defective SpO2 Sensor – 1”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Replace defective SpO2 sensor

6. “Defective SpO2 Sensor – 2”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Replace unrecognised SpO2 sensor

7. “SpO2 Sensor Off Patient”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Check SpO2 sensor

8. “SpO2 Sensor Interference Detected”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Check SpO2 sensor 16

9. “Low SpO2 Signal IQ”

The ventilator will display this alarm message and show dashes in the SpO2 value in the monitored parameter display. Action: Check SpO2 sensor

10. “Too Much Ambient Light (SpO2)”

Action: Check sensor and reduce ambient light

11. “Low Perfusion Index (SpO2)”

Action: Check sensor (too tight), Check patient (haemodynamic problem), Check ventilation parameters.

12. “High SpO2”

The ventilator will display this alarm message and flash the SpO2 value in the monitored parameter display. Action: Check patient/Check ventilation parameters/ Check alarms setting

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What can affect SpO2 measurements? •

• • • • •

• • • • 18

Placement of a sensor on the same extremity as a blood pressure cuff, arterial catheter, or intra-vascular line. The patient has hypotension, severe vasoconstriction, severe anaemia, or hypothermia. The patient is in cardiac arrest or is in shock. Significant level of dysfunctional haemoglobins (e.g., carboxyhaemoglobin or methaemoglobin) Interfering Substances: Any substance containing dyes such as indocyanine green or methylene blue, which change usual blood pigmentation and may cause erroneous readings. Exposure to excessive illumination: Bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material) Excessive patient movement. Venous congestion may cause under reading of actual arterial oxygen saturation. Therefore, assure proper venous outflow from monitored site. Venous pulsations may cause erroneous low readings (e.g. tricuspid value regurgitation). Patient suffers from abnormal pulse rhythm.

•

• •

With very low perfusion at the monitored site, the readings may read lower than core arterial oxygen saturation. If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. Excessive moisture can cause the pulse oximeter to perform inaccurately or fail. Sensors applied too tightly or that become tight due to oedema will cause inaccurate readings and can cause pressure necrosis. Watch the SpO2 video

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®

SLE Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL UK

Videos and other support materials such as clinical and technical information can be found below or contact your local representative for more.

Videos The SLE6000: The Lunar Interface High Frequency Oscillation Ventilation SpO2 monitoring and accessories Synchronised Intermittent Mandatory Ventilation Non-invasive Ventilation and accessories

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Masimo, SET and are federally registered trademarks of Masimo Corporation. OxyGenie® is a registered trade mark of SLE Ltd in the EU. | SLE and SLE6000 are trademarks of SLE Ltd. All other names, logos, and brands are property of their respective owners. | Copyright SLE Ltd ©2019 | Subject to Change | G0175/0UK/001 01/19

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