980 R7.0 Software Update Addendum Rev A May 2020

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European Community (EC) authorized representative Manufacturer-Ventilator manufacturer

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Table of Contents 1 Software Enhancements... 3 Overview... 3 Update to 4.7.2 NIV Breathing Interfaces... 3 Update to 4.7.3 NIV Setup... 3 Update to 4.7.4 Conversion from Invasive to NIV Ventilation Type... 4 Update to 5.4.2 Communication Setup... 4 Update to 5.4.7 SNDF Command... 4 Update to Table 5-2. MISCF Response... 4 Update to 6.6.21 Driving Pressure (PDRIVE)... 6 Update to Table 11-9. Ventilator Settings Range and Resolution... 6 Update to Table 11-11. Patient Data Range and Resolution... 6 Update to Table B-1. Maximum Leak Compensation Flow Based on Patient Type... 6 Update to Table B-2. DSENS Settings... 7 Update to Table D-3. Humidifier Volumes-Neonatal Patients... 7

Operator's Manual Addendum

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1. Software Enhancements 1.1. Overview This addendum describes enhancements to the 980 Ventilator System and changes to the 980 Ventilator System Operator’s Manual.

1.2. Update to 4.7.2 NIV Breathing Interfaces The following non-vented interfaces are compatible with the use of NIV/CPAP on the Puritan Bennett 980 ventilator: Full-face mask - ResMed Mirage™* non-vented full face mask Nasal mask - ResMed Ultra Mirage™* non-vented mask Infant nasal prongs - Argyle™* nasal prongs, Hudson RCI™* Infant Nasal prongs, Fisher & Paykel™* nasal prongs, Medin™* nasal prongs, and Ram cannula Uncuffed neonatal ET tube - Shiley™ Uncuffed tracheal tube, Murphy (3.0 mm)

1.3. Update to 4.7.3 NIV Setup To function as intended, DSENS needs to be set between the LEAK data value displayed while the patient is connected, and the LEAK data value displayed when the interface is open to ambient and not connected to the patient. To set DSENS with NIV interfaces when Leak Sync is enabled 1. 2.

After adjusting the patient settings, start ventilation. Ensure that Leak Sync is enabled and set DSENS to the highest setting.

3. 4.

Select LEAK (L/min) to be displayed in the patient data banner. With the NIV interface connected to the breathing circuit and open to ambient, use the patient data value called LEAK to quantify the leak in L/min. Set the DSENS (in L/min) below the leak rate (in L/min) to ensure that the disconnect alarm is violated during a disconnect. Note that this will cause a CIRCUIT DISCONNECT alarm. Connect the patient interface to the patient and ensure that the CIRCUIT DISCONNECT alarm is resolved. DSENS needs to be set higher than the LEAK data value displayed while the patient is connected and lower than the LEAK data value displayed when the interface is open to ambient and not connected to the patient. Periodically assess the leak rate, especially with PEEP changes, and adjust the DSENS setting as needed to ensure the presence of an alarm during disconnect and the absence of nuisance alarms while the interface is connected to the patient. Always use alternative methods of monitoring during NIV.

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Operator's Manual Addendum

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1.4. Update to 4.7.4 Conversion from Invasive to NIV Ventilation Type Note: Before switching to non-invasive ventilation from invasive ventilation when the EtCO2 sensor was used, ensure the EtCO2 option is disabled.

1.5. Update to 5.4.2 Communication Setup To specify the communication configuration for the ventilator 1. Touch the configure icon in the constant access icons area of the GUI. A menu appears with several tabs. 2. Touch the Comm Setup tab. The Comm Setup screen appears allowing three ports to be configured. These ports can be designated as DCI, DCI 2.0, DCI 3.0, Philips, Spacelabs, or Waveforms.

1.6. Update to 5.4.7 SNDF Command MISCF

1225*

169

<STX>

FIELD 5, … FIELD 173,

<ETX>

<CR>

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2

3

4

5

6

7

1

Response code to SNDF command

5

Data field, left-justified and padded with spaces

2

Number of bytes between <STX> and <CR> 6

End of transmission (03 hex)

3

Number of data fields between <STX> and <ETX>

7

Terminating carriage return

4

Start of transmission (02 hex)

*

1229 if Philips is selected for serial port in communication setup

Note: Ensure your external devices are compatible with the latest DCI software to prevent incompatibilities as data fields may have been modified.

1.7. Update to Table 5-2. MISCF Response

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Component

Description

Field 8

Ventilation Type (NIV______ or Invasive_ or HFO2T____) (9 characters)

Field 9

Mode (A/C___, SIMV__, SPONT_ or CPAP__) (6 characters)

Field 11

Spontaneous Type (PS____, TC____, VS____, PA____) (6 characters)

Field 12

Trigger Type setting (

Field 18

PEEP/CPAP setting in cmH2O (6 characters)

Field 56

Disconnect sensitivity (DSENS) setting in %, L/min or OFF (6 characters)

Field 78

Monitored Inspired tidal volume (VTI) in L# (6 characters) # VTL (L), If Leak Sync ON.

Field 87

Monitored Positive end expiratory pressure (PEEP) in cmH2O (6 characters)

Field 91

Monitored total PEEP (PEEPTOT) from expiratory pause maneuver in cmH2O (6 characters)

Field 101

Proximal Flow Sensor state (ON or OFF) (6 characters)

Operator's Manual Addendum

English

-Trig, P-Trig, IESYNC) (6 characters)

(continued) Component

Description

Field 116

Inadvertent Power Off alarm* (6 characters)

Field 127

Procedure error alarm* (6 characters)

Field 128

1

Compliance limited tidal volume (VTI) alarm* (6 characters)

Field 146

1

Technical malfunction A50* (6 characters)

Field 1471

Technical malfunction A55* (6 characters)

1

Field 148

Technical malfunction A60* (6 characters)

1

Field 149

Technical malfunction A65* (6 characters)

Field 150

Technical malfunction A70* (6 characters)2

Field 151

Technical malfunction A75* (6 characters)3

Field 152

Technical malfunction A80* (6 characters)4

Field 153

High ETCO2 Alarm* (6 characters)

Field 158

LEAK in L/min (6 characters)

Field 159

VLEAK in mL (6 characters)

Field 161

ETCO2 (mmHg) when COM port is set to DCI 2.0 or DCI 3.0 (6 characters). Otherwise Blank

Field 1625

Inspiratory Compliance ratio (C20/C) (6 characters)

5

Field 163

Three times Inspiratory Time Constant (3TauI) in seconds (6 characters)

Field 164

5

Delivered mL/kg Volume (VTI/PBW)#. # VTL/PBW (mL/kg), If Leak Sync ON. (6 characters)

Field 1655

Monitored Driving Pressure (PDRIVE) in cmH2O (6 characters)

Field 166

Monitored Positive End Expiratory Pressure at Patient Interface (PEEPIF) in cmH2O (6 char- acters)

Field 1675

Monitored End Inspiratory Pressure at Patient Interface (PI END IF) in cmH2O (6 characters)

Field 168

Monitored Constant Flow (

Field 1695

IE Sync Trigger Sensitivity (ISYNC) setting (6 characters)

Field 170

IE Sync Cycle Sensitivity (ESYNC) setting (6 characters)

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5

5

Field 171

5

Constant flow (

Field 172

5

Ventilator State (6 characters)

Field 173

Nebulizer State7 (6 characters)

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) in L/min (6 characters)

CONST

) setting in L/min (6 characters)

CONST 6

*Possible responses are: NORMAL, LOW, MEDIUM, HIGH, or RESET. 1

Fields 146 to 149 are blank for DCI 3.0.

2

Nebulizer Inoperative Alarm*, when COM port is set to DCI 3.0.

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CO2 Monitor Inoperative Alarm* when COM port is set to DCI 3.0.

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Low EtCO2 Alarm*, when COM port is set to DCI 3.0.

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Fields 162 to 173 are configured for DCI 3.0, otherwise Blank.

Possible Ventilator State responses are: STNDBY (Stand-By Mode), SAFPCV (Safety PCV), BREATH (Normal Breathing Mode), DISCON (Circuit Disconnect), OCCLUD (Occlusion), SVOPEN (Safety Valve Open), BUV (Backup Ventilation), MIX-BUV (Mixer Backup Ventilation), HFO2T, APNEA. 6

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Possible Nebulizer State responses are: ON, OFF, SUSPND (Suspended). Operator's Manual Addendum

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1.8. Update to 6.6.21 Driving Pressure (PDRIVE) While ventilating with PAV+™, Driving Pressure (PDRIVE) is the difference between Plateau pressure and estimated PEEPTOT and represents the amount of pressure required to overcome the elastic recoil of the lungs. PDRIVE can also be calculated by dividing VT by CPAV (VT/CPAV). PAV+™ software automatically performs a 300 ms end-inspiratory hold in a random pattern every four to ten PAV+™ breaths. Each time the end-inspiratory hold is conducted this pressure change is measured from the end expiratory lung pressure at the beginning of the breath to the pressure at the end of the plateau maneuver.

1.9. Update to Table 11-9. Ventilator Settings Range and Resolution Setting

Description

Range and resolution

Disconnect sensitivity (DSENS)

Leak Sync disabled: The percentage of returned volume lost, above which the ventilator declares a CIRCUIT DISCON- NECT alarm. Leak Sync enabled: The leak at PEEP value in L/min, above which the venti- lator declares a CIRCUIT DISCONNECT alarm.

Range (Leak Sync disabled): 20% to 95% or OFF Range (Leak Sync enabled): NEONATAL: Invasive: 1 L/min to 15 L/min NIV: 1 L/min to 30 L/min PEDIATRIC: 1 L/min to 40 L/min ADULT: 1 L/min to 65 L/min Resolution (Leak Sync disabled): 1% Resolution (Leak Sync enabled): 0.5 L/min for values < 10 L/min; 1 L/min for values ≥ 10 L/min

1.10. Update to Table 11-11. Patient Data Range and Resolution Data value

Description

Range and resolution

Driving Pressure (PDRIVE)

During PAV+™, PDRIVE is computed as the pressure difference between Pla- teau Pressure and the estimated PEEPTOT.

Range: 0 cmH2O to 90 cmH2O Resolution: 0.1 cmH2O for 0 cmH2O to 9.9 cmH2O;1.0 cmH2O for values 10 cmH2O to 90 cmH2O

1.11. Update to Table B-1. Maximum Leak Compensation Flow Based on Patient Type

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Patient type

Maximum leak compensation flow at PEEP

Maximum total flow

Neonatal

Invasive: 15 L/min NIV: 30 L/min (25 L/min if compressor is the air source)

50 L/min

Operator's Manual Addendum

English

1.12. Update to Table B-2. DSENS Settings Breathing circuit type

DSENS setting

Maximum total flow

Neonatal

Range: Invasive: 1 L/min to 15 L/min NIV: 1 L/min to 30 L/min Default: 2 L/min (Invasive ventilation) 5 L/min (NIV)

50 L/min

Pediatric

Range: 1 L/min to 40 L/min Default: 20 L/min

120 L/min

Adult

Range: 1 L/min to 65 L/min Default: 40 L/min

200 L/min

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1.13. Update to Table D-3. Humidifier Volumes-Neonatal Patients Manufacturer

Model

Description

Fisher & Paykel™*

MR290

Neo/adult, disposable, auto- 5501 feed

Teleflex™* (Concha)

382-10

ConchaSmart

390

AirLife™*

AH290

Disposable, autofeed

520

SST humidifier volume set- ting (mL)

If the following neonatal patient circuits are used with a Fisher & Paykel™* MR850 humidifier, enter 500 mL as the humidifier volume: 1

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DAR neonatal patient circuit with single heated wire (DAR 307S9910)–for incubator use

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DAR neonatal patient circuit with single heated wire (DAR 307/8682)–not for incubator use

Operator's Manual Addendum

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