980 Series High Flow Oxygen Therapy Option Addendum Rev A Feb 2021

COVIDIEN, COVIDIEN with logo and Covidien logo are trademarks of Covidien. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Covidien entity in the United States and/or in other countries. Puritan Bennett™ The information contained in this addendum is the sole property of Covidien and may not be duplicated without permission. This addendum may be revised or replaced by Covidien at any time and without notice. Ensure this addendum is the most current applicable version. If in doubt, contact Covidien’s technical support department. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. The ventilator should be operated and serviced only by trained professionals. Covidien’s sole responsibility with respect to the ventilator and software, and its use, is as stated in the limited warranty provided. Nothing in this document shall limit or restrict in any way Covidien’s right to revise or otherwise change or modify the equipment (including its software) described herein, without notice. In the absence of an express, written agreement to the contrary, Covidien has no obligation to furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its software) described herein. U.S. Patents: www.covidien.com/patents. Covidien is a Medtronic company.

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1 High Flow Oxygen Therapy (HFO2T) 1.1 Overview This addendum describes the operation of the Puritan Bennett 980 Series Ventilator High Flow Oxygen Therapy (HFO2T) software option, which provides a continuous flow of inspiratory gas to spontaneously breathing patients. See the Puritan Bennett 980 Series Ventilator Operator’s Manual for additional information on operating the ventilator.

1.2 Product Description HFO2T software adds an additional selection for ventilation type to the ventilator. When selected, HFO2T will deliver and maintain the operator-set constant flow (⩒ CONST) and O2% through a single limb circuit that is connected to an oxygen therapy interface. The vital patient data banner clearly indicates that HFO2T is active and displays monitored ⩒CONST and O2% (see Figure 1). Figure 1. PB980 HFO2T

HFO2T is used with a single-limb breathing circuit connected from the gas outlet (To patient port) of the ventilator, through the humidifier, to an HFO2T patient interface. During HFO2T, the ventilator’s graphical user interface (GUI) settings area displays: • Set constant flow rate (⩒ CONST) • Set O2%

During HFO2T, the ventilator’s GUI monitored patient data area displays: • Monitored (⩒ CONST)

• Monitored O2% (see Figure 2).

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Figure 2. PB980 HFO2T Vital Patient Data area and Settings area

1.3 Intended Use The HFO2T software option is intended to provide a constant flow of oxygen and air, which is ideally heated and humidified, to spontaneously breathing adult, pediatric, and neonatal patients using a single limb circuit.

1.4 Safety Terms This section contains safety information for users who should always exercise appropriate caution while using the ventilator. Table 1. Safety Terms Term Warning Caution Note

Definition Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment. Cautions alert users to exercise appropriate care for safe and effective use of the product. Notes provide additional guidelines or information.

1.5 Safety Information Warning: The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment, the condition and needs of the patient, and the benefits, limitations and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether or not those are best for the patient’s current needs. Warning: For proper delivery of HFO2T to the patient, the HFO2T interface must be connected directly to the inspiratory limb of the breathing circuit. The wye connector and expiratory limb are not used with HFO2T. 6

Warning: Do not use HFO2T with a dual-limb ventilator circuit that is connected to the ventilator’s exhalation filter or HFO2T will not be delivered properly to the patient. Warning: Ensure that the circuit being used does not have a pressure relief valve anywhere between the ventilator and the patient as this may prevent the ventilator alarms from working properly. Warning: To prevent impedance to patient exhalation and exposure to excess pressure, use only interfaces intended for HFO2T such as a high flow nasal cannula, a tee piece, an aerosol mask, a tracheal mask, an oxygen hood, an oxygen box, or an oxygen tent. Warning: To prevent CO2 rebreathing, ensure that the flow used during HFO2T is adequate to clear the HFO2T interface of exhaled CO2. Warning: As HFO2T does not provide mechanical ventilation or patient alarms like apnea or low minute volume, only use HFO2T on spontaneously breathing patients with adequate external monitoring to reduce the incidence of hypoventilation, hyperventilation, or lack of alveolar ventilation. Warning: Use an active heated, humidification system with the ventilator during HFO2T to add heat and moisture to the inhaled gas to prevent drying of airways and pulmonary secretions. See the Puritan Bennett 980 Series Ventilator Operator’s Manual for additional safety information.

1.6 Software Requirements The HFO2T software option must be installed and enabled by a Medtronic-trained service technician.

1.7 On-screen Symbols Table 2. Symbols and Abbreviations Symbol or abbreviation Monitored ⩒ CONST

Definition Constant flow Oxygen percentage

O2%

1.8 SST Requirements Prior to the use of HFO2T with a single-limb circuit, perform SST using a dual-limb circuit that is appropriately sized for the patient type. Although SST is not required for HFO2T, Medtronic recommends that SST be performed, in the event that the patient requires switching to invasive or noninvasive ventilatory support.

1.9 Using the HFO2T Function Review and follow all warnings prior to patient ventilation with the HFO2T feature. See Section 1.5, Safety Information, page 6. Configure the breathing circuit for HFO2T using a circuit from the Puritan Bennett 980 Series Ventilator Operator’s Manual or a Fisher & Paykel™* adult single limb circuit P/N RT202 or Optiflow™* junior single limb circuit P/N RT330: 1. Remove the expiratory limb and patient wye connector from the conventional dual limb ventilator breathing circuit. 2. Connect one end of the inspiratory, single limb to the heated humidification system outlet. 3. Connect the other end of the inspiratory, single limb to an appropriately sized HFO2T patient interface. Set up the ventilator to deliver HFO2T on a new patient prior to ventilation: 1. Select HFO2T as the Ventilation Type from the vent setup screen. 7

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2. Adjust ⩒ CONST and O2% settings as prescribed .

Note: The ventilator emits an audible tone when the recommended high flow limit is reached. To continue beyond this point, the operator must acknowledge a visual prompt. 3. Touch ACCEPT ALL to begin HFO2T.

Set up the ventilator to deliver HFO2T on a patient currently receiving ventilatory support: 1. Enter Stand-By before using HFO2T. Figure 3 shows that selecting HFO2T without first entering Stand-By results in a prompt that reminds the operator to enter Stand-By. 2. Assemble and connect a single limb circuit configuration according Step 1 to through Step 3 under Configure the breathing circuit for HFO2T. 3.

Touch the vent setup button at the bottom left of the GUI display screen. 4. Touch HFO2T as the Ventilation Type. 5. Adjust ⩒ CONST and O2% settings as prescribed.

6. Touch ACCEPT ALL to begin HFO2T. Note: If a SEVERE OCCLUSION alarm occurs while transitioning to HFO2T, the ventilator will not transition to HFO2T until the following steps are performed. a. Disconnect the inspiratory limb at the (To patient port). b. Touch the Alarm Reset key. c. Reconnect the inspiratory limb. d. Verify that (HFO2T Active) is displayed at the top of the screen.

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Figure 3. HFO2T with current patient with Stand-By prompt

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To monitor the patient on HFO2T: Observe the GUI vital patient data area for displays of monitored ⩒ CONST and O2% (see Figure 4). Figure 4. PB980 HFO2T Vital Patient Data

To disable HFO2T and initiate conventional positive pressure ventilatory support: 1. Reconfigure the HFO2T breathing circuit to a dual-limb configuration by attaching the expiratory limb and patient wye connector to the inspiratory limb previously used for HFO2T. 2. Connect the free end of the expiratory limb to the ventilator’s expiratory filter. 9

3.

Touch the vent setup button. 4. Touch either Invasive or NIV as the desired Ventilation Type. 5. Adjust mode, breath type, and settings as prescribed. 6. Touch ACCEPT ALL (see Figure 5). Figure 5. Transitioning from HFO2T to Invasive Ventilation

1.10 Alarms The following alarm events are associated with the HFO2T feature: Note: No user-settable alarms are available. • HIGH DELIVERED O2%-Alarm indicates the delivered O2 percentage is at or above the error percentage above the O2% setting for at least 30 s. The error percentage is 7% (12% during the first hour of operation). These percentages increase by 5% for 4 min following a decrease in the O2% setting. Note: The 30 second time delay is intended to eliminate nuisance alarms after changes to set O2% while delivering low flows. • LOW DELIVERED O2%-Alarm indicates the delivered O2% is at or below the error percentage, or less than or equal to 18%, for at least 30 s. The error percentage is 7% (12% during the first hour of operation). These percentages increase by 5% for 4 min following an increase in the O2% setting. • ↓⩒CONST-Alarm indicates the delivered constant flow is < 80% of set for ≥ 5 s due to back pressure > 40 cmH2O from the breathing circuit and interface (see Figure 6). • ⩒EXP-Alarm indicates the ventilator has detected expiratory flow > 0.5 L/min (see Figure 7). 10

Note: Alarm indicates the ventilator has detected a conventional breathing circuit. Table 3. Alarm Summary Base message ↑O2% (patient data alarm)

Priority Medium High

↓O2% (patient data alarm)

High

↓⩒CONST(patient data alarm) ⩒EXP(patient data alarm)

Medium Medium

Remedy Message / Analysis message Response Measured O2% > set for Check patient, gas ≥ 30 s but <2 min. sources, O2 analyzer Measured O2% > set for and ventilator. ≥ 2 min. Measured O2% < set Check patient, gas O2% sources, O2 analyzer and ventilator. Low measured constant Check circuit for occluflow. sion. Expiratory Limb Connected.

Figure 6. HFO2T Low Measured Constant Flow alarm

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Use inspiratory limb with high-flow patient interface. Disconnect wye and exhalation limb.

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Figure 7. HFO2T Expiratory Limb Connected alarm

1.11 Specifications Table 4 lists the ventilator parameters, accuracy, range, and resolution. Table 4. Ventilator Parameters, Accuracy, Range, and Resolution Parameters Accuracy

⩒CONST

O2%

Range and resolution Rangea: ADULT: 1 L/min to 80 L/min (softbound alert at 60 L/min) PEDIATRIC: 1.0 L/min to 50 L/min NEONATAL: 1.0 L/min to ± (0.5 L/min+ 10% of the setting) 50 L/min L/min BTPS Resolution: 0.5 L/min for values < 10 L/min 1 L/min for values ≥ 10 L/min Default: ADULT: 30 L/min PEDIATRIC: 10 L/min NEONATAL: 2 L/min Range: 21% to 100% ± 3% (absolute) Resolution: 1%

a For all patient types, the actual flow delivered to the patient, regardless of the setting, is restricted by the

ventilator’s safety system, which decreases the flow delivered as pressure approaches 50 cmH2O in order to limit pressure to no greater than 50 cmH2O.

Note: See the Puritan Bennett 980 Series Ventilator Operator’s Manual for additional specifications.

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