980 Series Users Pocket Guide Rev B Dec 2014

©2012 Covidien. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. *Proportional Assist and PAV are registered trademarks of The University of Manitoba, Canada. Used under license. Other brands are trademarks of a Covidien company. The information contained in this pocket guide is the sole property of Covidien and may not be duplicated without permission. It may be revised or replaced by Covidien at any time and without notice. While the information set forth herein is believed to be accurate, it is not a substitute for the exercise of professional judgment. Covidien’s sole responsibility with respect to the ventilator, and its use, is as stated in the limited warranty provided. Nothing in this publication 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.

CONTENTS 1.0) Ventilator Tour... 1 1.1) Graphic User Interface (GUI) Touchscreen... 1 1.2) Control Keys... 2 1.3) Areas of the Touchscreen... 3 1.4) Visual Indicators... 4 1.5) Breath Delivery Unit (BDU) Front View... 6 1.6) Breath Delivery Unit (BDU) Rear View... 7 2.0) Power Sources... 8 3.0) Common Tasks... 8 3.1) Initial Setup... 8 3.1.1) Quick Start Set-up ...9 3.1.2) Standard New Patient Set-up...9 3.2) Ventilation After Temporary Non-ventilation ... 10 3.3) Return to Previous Patient Settings... 10 4.0) Modes and Breath Types... 10 4.1) Ventilation Settings Adjustment... 10 4.2) Mandatory Ventilation: A/C Mode... 11 4.2.1) Volume Control (VC)...11 4.2.2) Pressure Control (PC)...11 4.2.3) Volume Control Plus (VC+)...11 4.3) Spontaneous Ventilation: SPONT Mode... 11 4.3.1) Volume Support (VS)...11 4.3.2) Pressure Support (PS)...12 4.3.3) Tube Compensation (TC)...12 4.3.4) PAV™*+ Software...12 4.4) Mixed Mode Ventilation: SIMV & BiLevel... 15 4.4.1) Synchronous Intermittent Mandatory Ventilation (SIMV)...15 4.4.2) Bilevel...15 5.0) Noninvasive (NIV) and Leak Sync... 15 5.1) Approved NIV Breathing Interfaces... 16 5.2) Conversions for INVASIVE and NIV Vent Types... 17 5.3) Leak Sync Software... 17

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6.0) NeoMode 2.0 Software... 19 6.1) CPAP... 19 6.2) The Proximal Flow Sensor... 20 6.2.1) Proximal Flow Usage...20 6.2.2) Proximal Flow Alarms...22 7.0) Apnea and Alarm Settings...22 7.1) Apnea Settings... 22 7.2) Alarm Settings... 23 8.0) Respiratory Mechanics Maneuvers... 24 8.1) Inspiratory Pause Maneuvers... 25 8.2) Expiratory Pause Maneuvers... 25 8.3) Negative Inspiratory Force (NIF) Maneuver... 25 8.4) Occlusion Pressure Maneuver (P0.1)... 26 8.5) Vital Capacity Maneuver (VC)... 26 9.0) Monitored Patient Data... 27 9.1) Waveforms and Loops... 27 9.2) Touchscreen Brightness... 29 9.3) Display Lock... 29 9.4) Data Storage and Retrieval... 29 9.5) Large Patient Data Display... 29 10.0) Alarms... 30 10.1) Audible Alarm Types... 30 10.2) Visual Alarm Types... 31 10.3) Active Alarm Banners... 31 10.4) Alarm Examples... 32 11.0) Fine Tune Settings... 32 11.1) Rise Time %... 32 11.2) Expiratory Sensitivity (ESENS)... 32 11.3) Disconnect Sensitivity (DSENS)... 33 12.0) Safety... 33 12.1) New Ventilator Safety Features... 33 12.2) Established Ventilator Safety Features... 34

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13.0) Testing... 35 13.1) Extended Self Test (EST)... 35 13.2) Short Self Test (SST)... 35 13.2.1) Running SST...35 13.2.2) SST Results...36 14.0) The Oxygen Sensor... 37 14.1) Oxygen Sensor Function... 37 14.2) Oxygen Sensor Calibration... 37 14.3) Disable or Enable the Oxygen Sensor... 37 15.0) Preventive Maintenance... 38 Covidien Centers... 40

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Dear valued Puritan Bennett™ 980 ventilator user, We hope you are enjoying your Puritan Bennett 980 ventilator. This pocket guide provides an overview of the ventilator, acting as a supplement to the Operator’s Manual, and was designed to help guide you through the typical, everyday process of setting up and using the ventilator. We want you to get the most out of your ventilator, so in this guide you will find descriptions of our advanced modes, safety features and data capture capabilities, among other useful tips. The ventilator should be operated and serviced only by professionals trained specifically on the Puritan Bennett™ 980 ventilator. It is important to familiarize yourself with all information in the Operator’s Manual relevant to your institution’s use of the ventilator, including on-screen helps, instructions, warnings and cautions. This pocket guide is intended to supplement, not replace, the

Operator’s Manual, which should always be available while using the ventilator. Should you encounter any questions or concerns not covered in this guide or the Operator’s Manual, contact Covidien Technical Services at 1.800.255.6774 or your local Covidien representative, per the list at the end of this guide.

1.0) VENTILATOR TOUR The Puritan Bennett™ 980 Ventilator System is designed for use on patient population sizes from neonatal (NICU) through adult who weigh a minimum of 0.3 kg. The customizable touchscreen interface provides improved navigation, information visibility and ventilation management.

1.1) Graphic User Interface (GUI) Touchscreen

1. Display brightness key

6. Inspiratory pause key

2. Display lock key

7. Expiratory pause key

3. Alarm volume key

8. Alarm reset key

4. Manual Inspiration key

9. Alarm silence key

5. Rotary encoder (knob)

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1.2) Control Keys Key symbol

Description Display brightness key-Adjusts screen brightness. Press the key and turn the knob to adjust touchscreen brightness. Display lock key-Prevents inadvertent settings changes to the ventilator (including the knob function). Useful when cleaning the touchscreen. Press again to unlock. Alarm volume key-Adjusts the alarm volume. The alarm volume cannot be turned OFF.

Manual inspiration key-Use to deliver mandatory breaths to the patient or to run an inspiratory pause maneuver in SPONT mode. In A/C, SIMV and SPONT modes, delivers one manual breath to the patient based on current mandatory breath parameters. In BiLevel mode, transitions from low pressure (PL) to high pressure (PH) (or vice versa). Inspiratory pause key-Initiates an inspiratory pause that closes the inspiratory and exhalation valves and extends the inspiratory phase of a mandatory breath while measuring end inspiratory pressure (PI END) for calculation of plateau pressure (PPL), static compliance (CSTAT) and static resistance (RSTAT). Expiratory pause key-Initiates an expiratory pause that extends the expiratory phase of the current breath in order to measure total PEEP (PEEPTOT). Alarm reset key-Clears active alarms or resets high-priority alarms and cancels an active alarm silence. An alarm reset is recorded in the alarm log if there is an active alarm. DEVICE ALERT alarms cannot be reset. Alarm silence key-Silences alarms for two minutes. Touch Cancel to halt the alarm silence.

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1.3) Areas of the Touchscreen

1.

Patient data area

2.

Alarm banners

3.

Constant access area

4.

Constant access icons

5.

Current settings area

6.

Vent Setup button

7.

Patient type indicator

8.

Prompt area

9.

Menu tab

10.

Waveform area

11.

Breath phase indicator

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1.4) Visual Indicators Symbol

Description Low-priority alarm icon-Appears on alarm banner.

Medium-priority alarm icon-Appears on alarm banner. High-priority alarm icon-Appears on alarm banner.

Maximize waveform icon-Enlarge the waveform to its maximum size with a touch. Restore waveform icon-Restore the waveform to its original size with a touch.

Waveform layout icon-View up to five waveforms simultaneously. Open the waveform layout dialog with a touch. Grid lines icon-Turn waveform grid-lines on or off with a touch. Vent Setup button-Open the ventilator setup screen with a touch.

Home icon-Touch to dismiss all open dialogs.

Alarms icon-Touch to display alarm settings.

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Symbol

Description Configure icon-Touch to access the SST screen. Perform all the SST tests or a single SST test. Also use to access options, comm setup, or to change date and time. Logs icon-Touch to display the logs screen, which contains tabs for Alarms, Settings, Patient Data, Diagnostics, EST/SST status, General Event and Service logs. Unread items icon-Overlays other icons or tabs to indicate unread items at this location. Elevate O2 control-Touch to increase the set oxygen concentration for two minutes. Screen capture icon-Touch to capture the image displayed on the screen.

Help icon-Drag to the item in question and release. A tooltip will appear describing the item’s function. Pause icon-Touch to pause the waveform graph.

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1.5) Breath Delivery Unit (BDU) Front View

1. Power switch

6. Status display

2. AC power indicator

7. Internal inspiratory filter

3. Expiratory filter latch

8. Option connector panel door

4. Expiratory filter 5. Condensate vial

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1.6) Breath Delivery Unit (BDU) Rear View

1. Oxygen inlet

a. Service mode switch

d. HDMI port

2. Air inlet

b. USB port (2x)

e. Ethernet connector

3. Cylinder mount

c. Remote alarm port

f. Service port g. RS-232 serial port

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2.0) POWER SOURCES Batteries charge whenever the ventilator is connected to AC power, whether the ventilator is operating or not. The ventilator’s primary battery will fully charge within six hours. A fully charged battery will provide approximately one hour of ventilation, depending on settings. The ventilator charges its primary battery first, then its extended battery. An optional, extended battery is available. When operating on battery power, the ventilator status display indicates the estimated charge level of the installed batteries. Battery life is approximately three years. Actual battery life depends on the history of use and ambient conditions.

3.0) COMMON TASKS Warning: In case of ventilator failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient death. An alternative source of ventilation, such as a self-inflating, manually-powered resuscitator (as specified in ISO 10651-4 with mask) should always be available when using the ventilator. Warning: Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run SST as described in this guide. The easy-viewing touchscreen rotates in either direction and also allows for a tilt of up to 45⁰ from vertical for easy viewing.

3.1) Initial Setup From the New Patient prompt, select either Quick START (3.1.1) or begin with the standard new patient setup (3.1.2).

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3.1.1) Quick Start Set-up Quick Start allows for rapid setup and initiation of mechanical ventilation. Ensure Quick Start parameters are consistent with institutional practice before using this feature. 1.

Touch New Patient.

2.

Touch the highlighted PBW or Gender/Height.

3.

Turn the knob to adjust.

4.

Touch Quick START.

5.

Connect the circuit wye adapter to the patient’s airway or interface connection.

3.1.2) Standard New Patient Set-up 1.

Touch New Patient. The New Patient settings screen allows entry of ventilation control parameters.

2.

Enter the patient’s PBW or gender and height.

3.

If default settings are appropriate for the patient, touch START to confirm. Otherwise, touch the parameter and turn the knob to adjust the setting. Continue for all parameters needing adjustment.

4.

Touch START to confirm change(s).

5.

Connect circuit to patient’s airway to begin ventilation.

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3.2) Ventilation After Temporary Non-ventilation Ventilation of a patient who has been disconnected but whose settings were already configured is easy. 1. Touch Same Patient. Previous ventilator settings appear for review prior to applying to the patient. 2. If settings are acceptable, Touch START. Otherwise, make necessary changes and touch Accept. 3. Connect circuit to patient’s airway to initiate ventilation.

3.3) Return to Previous Patient Settings 1. Touch Previous Setup. 2. If the settings are acceptable, touch Accept or Accept ALL.

4.0) MODES AND BREATH TYPES 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. The Puritan Bennett™ 980 ventilator provides mandatory, spontaneous, and two forms of mixed mode ventilation. A/C, SIMV, SPONT, BiLevel, and CPAP Mandatory Breath Types PC

VC

VC+

Spontaneous Breath Types PS

TC

VS

PAV™*+

4.1) Ventilation Settings Adjustment 1.

Touch Vent Setup button.

2.

Touch, then turn the knob to adjust each parameter needing adjustment.

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3.

Touch Accept or Accept ALL.

4.2) Mandatory Ventilation: A/C Mode Assist/control (A/C) mode requires the practitioner to choose patient breath delivery settings. All breaths are mandatory, and can be pressure-controlled (PC), volume-controlled (VC), or VC+. Mandatory breath triggering methods can be P-TRIG, v-TRIG, time-triggered, or operator-initiated. 4.2.1) Volume Control (VC) Volume Control breaths are based on a target tidal volume and flow rate. Peak pressure can fluctuate to ensure the target tidal volume is delivered, regardless of changes in compliance and resistance. 4.2.2) Pressure Control (PC) Pressure Control breath delivery is based on achieving and sustaining a pressure target at a set rate. The patient can trigger the ventilator with effort. 4.2.3) Volume Control Plus (VC+) Volume Control Plus breath type provides a mandatory, pressure-controlled breath that does not restrict flow during the inspiratory phase, and automatically adjusts the inspiratory pressure target from breath to breath to achieve the desired tidal volume, despite changing lung conditions.

4.3) Spontaneous Ventilation: SPONT Mode SPONT mode breath types include Pressure Support (PS), Volume Support (VS), Tube Compensation (TC), and Proportional Assist™* Ventilation Plus (PAV™*+). 4.3.1) Volume Support (VS) The clinician sets both PEEP and target tidal volume. The set tidal volume is delivered to the patient with varying levels of support depending on the patient’s effort. If patient effort increases, pressure will drop to keep the patient near the target tidal volume. Puritan Bennett™ 980 Ventilator System User’s Pocket Guide | 11

4.3.2) Pressure Support (PS) PS requires a preset pressure and allows the patient to control the inhaled tidal volume. The patient can do almost no work or nearly all of the work depending on the percentage of support provided.1 Patients may draw large breaths if desired, but may have to work harder to receive them, depending on pressure and expiratory sensitivity settings. Support does not rise to accommodate a large effort. The breath cycles off when reaching a given percentage of peak inspiratory flow (ESENS). 4.3.3) Tube Compensation (TC) The ventilator delivers positive pressure to overcome the additional work of breathing imposed by an artificial airway. To enable TC: 1.

Touch the Vent Setup button.

2.

Touch SPONT for the mode selection and TC for Spontaneous type.

3.

Finish setting up the ventilator as described above.

4.

Select the tube type (either endotracheal or tracheostomy) and set the proper tube ID.

5.

After making the changes, touch Accept ALL to apply the new settings, or Cancel the last change.

To select new settings for the tube: 1.

Touch Vent Setup button.

2.

Touch Tube Type or Tube ID to change.

3.

Turn the knob to change the setting.

4.

Make other tube settings, as necessary.

5.

Touch Accept ALL to apply the new settings, or Cancel the last change.

4.3.4) PAV™*+ Software The PAV™*+ breath type enables the patient to help dictate the breath he or she receives, and helps clinicians more clearly understand the work required by the patient to 12 | Puritan Bennett™ 980 Ventilator System User’s Pocket Guide

complete each breath.2, 3 The PAV™*+ breath type is indicated for use in spontaneously breathing adult patients whose ventilator predicted body weight (PBW) setting is at least 25.0 kg (55 lb). Patients must be intubated with either endotracheal (ET) or tracheostomy (trach) tubes of internal diameter (ID) 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive. The clinician sets a desired percent support, and then uses the provided Work of Breathing (WOB) bar for real-time feedback on the appropriateness of the support provided. • Estimates of work of breathing relative to normal, subnormal and above-normal values • An indicator showing the proportion of patient inspiratory work relative to the total work of breathing

This enables clinicians to keep the patient at a sustainable level of work-reducing the risk for respiratory muscle atrophy, but potentially offloading enough work to avoid fatigue.2, 4, 5 With the PAV™*+ breath type, the patient and the ventilator share in the work of breathing. The percent WOBTOT performed by the ventilator equals the % Supp setting and the percent WOBTOT performed by the patient equals (100 minus the % Supp setting). WOBTOT is the sum of the work to move the breathing gas through the artificial airway and the patient’s own airways plus the work to inflate the patient’s elastic lung-thorax. The WOBPT is the portion of the total work performed by the patient. With PAV™*+ selected, Leak Sync is disabled. The ventilator uses soft- and hard-bound values for estimated tube ID based on PBW.

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Warning: Ensure that the correct artificial airway ID size is entered. Because PAV™*+ amplifies flow, entering a smaller-than-actual airway ID causes the flow-PAV™*+ based pressure assistance to over-support the patient. Conversely, entering a larger-than-actual ID results in under-support. Do not use non-invasive patient interfaces such as masks, nasal prongs, uncuffed ET tubes, etc. as leaks associated with these interfaces may result in over-assist and patient discomfort. To set up the PAV™*+ breath type: 1.

Touch Vent Setup button.

2.

Touch Invasive vent type.

3.

Touch SPONT mode.

4.

Touch PAV™*+ to select spontaneous type.

5.

Touch the desired trigger type (P-TRIG or v-TRIG).

6.

Select tube type and ID; initially, a default value is shown based on the PBW entered at ventilator startup. If this ID is not correct for the airway in use, turn the knob to adjust the ID setting.

1. 2. 3.

Shadow trace (trace of the estimated lung pressure) Patient’s work of breathing (WOBPT) Total work of breathing (WOBTOT)

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