800 Series Ventilator System Operator’s Manual Addendum Rev E Software Enhancements

Software Enhancements Figure 6: New patient ventilator settings screen-NIV... 29 Figure 7: More patient data screen-NIV... 29 Table 7: Visual differences between NIV and INVASIVE vent types... 30 NIV setup... 31 High Spontaneous Inspiratory Time limit setting... 33 Apnea setup... 34 Alarm setup... 34 Figure 8: New patient alarm settings... 35 Changing patient from INVASIVE to NIV Vent Type... 36 Table 8: Automatic settings changes-INVASIVE to NIV... 36 Changing patient from NIV to INVASIVE Vent Type... 37 Table 9: Automatic settings changes-NIV to INVASIVE... 37

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Introduction This addendum describes enhancements to the 840™ Ventilator System and changes to the 840 Ventilator System Operator’s and Technical Reference Manual (part number 4-070088-00) up to and including Revision D. Updates to the manual include: •

The patient circuit type specified during short self test (SST) determines default settings and available ranges for ventilator operation.

•

Certain recommended ranges can be overridden. Touching the OK button allows operation outside the recommended setting range.

•

The humidification type can be changed after running SST without adversely affecting breath delivery or spirometry, and humidifier volume can be entered for non-HME humidifiers during or following SST.

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A prompt has been added at the start of the SST compliance test to allow the operator to check for the presence of water in the humidifier.

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A reminder arrow now flashes at the Ventilator Startup screen to prompt the operator to consider previous settings.

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Display of data on the upper GUI screen is larger for improved visibility at a distance.

•

Alarm Silence in Progress and 100% O2/CAL in Progress indicators (when active) and the CANCEL buttons for them are displayed on the lower GUI screen.

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The main settings (buttons displayed at the top of the lower screen) can be set individually or in a batch to allow quick setup.

•

Drop-down menus of available selections have been added for mode, mandatory type, spontaneous type, trigger type, apnea mandatory type, and graphics plot setup.

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The lower screen displays monitored settings if you select or change the settings that affect them: − Selecting or changing the volume setting displays the current volume per weight ratio (VT/IBW or VT SUPP/IBW). − Selecting or changing the respiratory rate or volume setting displays the set minute volume (VE SET).

•

Expiratory sensitivity (ESENS) is now a primary setting that appears at the top of the lower screen. ESENS can be set as high as 80% for leak management.

•

The alarm setting bars on the alarm setup screen display the recent range of the corresponding patient data.

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Circuit disconnect and patient data alarms no longer reset an active alarm silence.

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Oxygen sensor calibration (100% O2 CAL) can be canceled.

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An automatic expiratory or inspiratory pause maneuver can be canceled by touching the CANCEL button on the lower GUI display.

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If the ventilator enters idle mode or an occlusion status cycling (OSC) state when NeoMode™ is active, the ventilator delivers 40% O2 if available.

•

Peak Circuit Pressure (PPEAK) shows the peak inspiratory pressure, and is updated at the end of each inspiration. Previously, this number represented the peak pressure for the whole breath.

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Mean Circuit Pressure (PMEAN) indicates the average circuit pressure over all breaths for the previous 1-minute interval.

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The O2 sensor alarm is no longer a DEVICE ALERT alarm.

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Various alarm parameters have been changed to reduce the occurrence of nuisance alarms.

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The following have changed: P %

This symbol is now defined as Rise Time Percent (was Flow Acceleration). The symbol has not changed.

PMEAN

New symbol for mean airway pressure (was PCIRC).

PPEAK

New symbol for peak circuit pressure (monitored) (was PCIRC MAX).

PEEP

New symbol for end expiratory pressure (monitored) (was PE END).

VE SET

New symbol, now defined as set minute volume (was V and defined as minute volume).

CSTAT

New symbol for static compliance (was C).

RSTAT

New symbol for static resistance (was R).

•

The extended self test (EST) compressor leak test now takes approximately one minute (was five minutes).

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Several spontaneous data parameters (rapid shallow breathing index, spontaneous inspiratory time, and spontaneous percent inspiratory time) have been added to the More Patient Data screen.

•

Graphics displays have been enhanced to show estimated carinal pressure when the TC or PA spontaneous breath type is active.

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Frozen graphics can now be printed.

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The clinician must now select a Ventilation Type, either INVASIVE or NIV (Non-invasive Ventilation), during new patient set-up.

•

The INSPIRATION TOO LONG alarm now applies only to INVASIVE Vent Type, and a High Spontaneous Inspiratory Time Limit (2TI SPONT) ventilator setting is available for NIV Vent Type with SIMV and SPONT breath modes.

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Update to patient circuit ranges This section updates Operator’s Manual section 2.3. Warning When using a Fisher & Paykel humidifier with the 840 Ventilator, use the Fisher & Paykel model 210 or 250 humidifier chamber for adult patients and the model 220 or 290 humidifier chamber for pediatric patients. Other Fisher & Paykel humidifier chambers can cause water to splash into the patient circuit during circuit disconnects and high peak flow rate conditions.

Patient circuit type selection Table 1 shows IBW values and patient circuit types. The “Allowed but not recommended” ranges require an override. Table 1: Patient circuit and IBW values Recommendation

Ideal body weight (IBW) in kg (lb)

Recommended

Neonatal: 0.5-7.0 kg (1.1-15 lb) Pediatric: 7.0-24 kg (15-53 lb) Adult: 25-150 kg (55-330 lb)

Allowed but not recommended

Neonatal: Not applicable Pediatric: 3.5-6.5 kg (7.7-14.3 lb), and 25-35 kg (55-77 lb) Adult: 7-24 kg (15-53 lb)

Warning Recommended ranges exist to ensure patient safety. Only those with expertise to judge the appropriate circumstances should override the recommended ranges.

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Update to short self test (SST) and humidification type This section updates the Operator’s Manual sections 3 and 4.8.

SST setup For optimum inspiratory volume and spirometry accuracy, SST asks you to specify the humidification type: Heated exp tube, Non-heated exp tube, or HME (HME = heat-moisture exchanger). For non-HME humidifiers, you can touch the Humidifier Volume button, then turn the knob to select the dry humidifier volume (the humidifier’s specified volume, not compressible volume). The Humidifier Volume button is not visible when HME is selected.

SST compliance calibration For a humidification type of Heated exp tube or Non-heated exp tube, the ventilator prompts you to indicate if there is water (Yes or No) in the humidifier.

Changing humidification type after SST For optimum spirometry accuracy, humidification type and volume (for non-HME humidifiers) can now be changed after running SST. Follow these steps to select the humidification type and set its volume: 1. Touch the Other Screens button, then touch the More Settings button. 2. Touch the Humidification Type button, then turn the knob to select the new value (Heated exp tube, Non-heated exp tube, or HME). 3. For non-HME humidifiers, touch the Humidifier Volume button, then turn the knob to select the dry humidifier volume. (The Humidifier Volume button is not visible when HME is selected.) 4. Review the proposed settings, then press ACCEPT to apply the new settings.

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Update to ventilator startup screen This section updates Operator’s Manual section 4.1. The Ventilator Startup screen (Figure 1 below) has changed: •

Expiratory sensitivity (ESENS) is now a primary setting and appears at the top of the lower GUI screen.

•

The startup screen includes flashing reminder arrow (next to the SAME PATIENT button) that prompts the user to consider previous settings.

•

During and after Ventilator Startup, drop-down menus of available selections are displayed for mode, mandatory type, spontaneous type, trigger type, and apnea mandatory type.

•

Once Ventilator Startup is complete, the volume per weight ratio is displayed when the volume setting is selected or changed. Volume = tidal volume (VT) when breath type is VC, target volume (VT) when breath type is VC+, target support volume (VT SUPP) when breath type is VS.

•

VE is no longer displayed in the Ventilator Startup screen.

•

For additional changes to Ventilator Startup screen, see “Ventilation Type - INVASIVE/NIV” on page 25.

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Figure 1: Ventilator Startup screen

Update to normal ventilation screens This section updates Operator’s Manual section 4.2. The upper GUI screen (Figure 2 below) now displays patient data in large characters on a single line for improved distance visibility. Breath type is indicated in the upper left corner (C = control, S = spontaneous, A = assist). To view units and symbol definitions at the bottom of the screen, touch the displayed symbol. Additional data is available on the More Data screen. For additional changes to normal ventilation screens see “Ventilation Type - INVASIVE/NIV” on page 25.

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Figure 2: Upper GUI screen The lower GUI screen (Figure 3) shows the Alarm Silence In Progress and the 100% O2/CAL In Progress indicators if no higher-priority display is active. The lower screen automatically displays the In Progress indicators when you press the 100% O2/CAL 2 min key.

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Figure 3: Lower GUI screen

Update to main settings changes This section updates Operator’s Manual section 4.3 to reflect that main settings can now be changed in a batch to allow quick setup. Main settings are the buttons displayed at the top of the lower screen. Follow these steps to change main settings: 1. Touch a setting you want to change. Turn the knob to set the desired value. 2. Repeat for each setting to be changed. 3. Touch CANCEL ALL to cancel the new input and leave the settings unchanged. 4. Touch ACCEPT to apply the new setting(s).

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The lower screen displays monitored settings (Table 2) if you select or change the settings that affect them: Table 2: Monitored settings VE SET

Set minute volume: displayed along with the breath timing bar whenever you select or change the respiratory rate (f) or volume setting.

VT/IBW

Volume per weight ratio: displayed when you select or change the tidal volume (VT, when breath type is VC) or target volume (VT, when breath type is VC+) setting.

VT SUPP/IBW

Volume per weight ratio: displayed when you select or change the target support volume (VT SUPP, when breath type is VS) setting.

Update to mode, breath type, and batch (multiple) settings changes This section updates Operator’s Manual section 4.4 to reflect that VE is no longer displayed in the Current Vent Setup screen.

Update to apnea ventilation settings changes This section updates Operator’s Manual section 4.6 to reflect that when the apnea mandatory type is selected in the Apnea Setup screen, a drop-down menu of all available selections is displayed with the current selection highlighted. Apnea set minute volume is no longer displayed in the Apnea Setup screen.

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Update to setting alarms This section updates Operator’s Manual section 4.7 to reflect the updated Alarm Setup screen (Figure 4). Alarm setting bars now include a highlighted block that represents the recent range of the corresponding patient data.

Figure 4: Alarm setup screen

Update to more settings This section updates Operator’s Manual section 4.8. The More Settings screen has changed: •

ESENS has been removed (and is now a primary setting).

•

Humidifier Volume (for non-HME humidifiers) has been added.

The procedure for changing any setting on the More Settings screen is the same.

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Updated ranges for settings, alarms, and data This section updates Operator’s Manual section 4.9 and Appendix A.6, and includes only changes to ventilator settings or alarms. Ventilators equipped with the NeoMode option can select all ranges (neonatal, pediatric, or adult). Only pediatric and adult ranges are available to ventilators without the NeoMode option. Some settings have recommended limits that can be overridden. When a proposed setting exceeds the recommended limits, the ventilator sounds a tone and asks you to confirm that you want to override the recommended range. Table 3 lists changes to ventilator settings. Table 4 lists changes to alarm settings. Table 5 lists additions to patient data. Table 3: Ventilator settings updates Setting

Function/Details

Apnea mandatory type

New patient value: Neonatal: Same as non-apnea mandatory type when non-apnea mandatory type is PC or VC. PC when non-apnea mandatory type is VC+. Pediatric: Same as non-apnea mandatory type when non-apnea mandatory type is PC or VC. VC when non-apnea mandatory type is VC+. Adult: Same as non-apnea mandatory type when non-apnea mandatory type is PC or VC. VC when non-apnea mandatory type is VC+.

Apnea interval (TA)

New patient value: Neonatal: 10 s Pediatric: 15 s Adult: 20 s

Apnea respiratory rate (f)

New patient value: Neonatal: 20/min Pediatric: 14/min Adult: 10/min

Expiratory sensitivity (ESENS)

Range: 1% to 80%, 1 to 10% for PAV+ option New patient value: 25%, 3% for PAV+ option

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Table 3: Ventilator settings updates Setting Flow pattern

Function/Details Range: Flow pattern not selectable when mandatory type is PC or VC+. New patient value: Neonatal: Descending ramp Pediatric: Square when mandatory type is VC Adult: Square when mandatory type is VC

Flow sensitivity (VSENS)

Range:

High spontaneous inspiratory time limit (2TI SPONT) (Available when Vent Type is NIV, only)

Range: Neonatal: 0.4 sec to (1 + (0.1 x IBW)) sec Pediatric/Adult: 0.4 sec to (1.99 + (0.02 x IBW)) sec New patient value: Neonatal: (1 + (0.1 x IBW)) sec Pediatric/Adult: (1.99 + (0.02 x IBW)) sec

Neonatal: 0.1 L/min to 10 L/min Pediatric/Adult: 0.2 L/min to 20 L/min New patient value: Neonatal: 1.0 L/min Pediatric: 2.0 L/min Adult: 3.0 L/min

Humidifier volume Function: The empty volume of the currently-installed humidifier. Range: 100 mL to 1000 mL Default: 480 mL Resolution: 10 mL

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Table 3: Ventilator settings updates Setting

Function/Details

Ideal body weight (IBW)

Range:

Inspiratory time (TI )

New patient value: Based on VT and VMAX Resolution: 0.01 s when mandatory type is PC or VC+, 0.02 s when mandatory type is VC.

Mandatory type

Function: Sets the type of mandatory breath: volume control (VC), pressure control (PC), or volume control plus (VC+). VC+ is only available with the Volume Ventilation Plus option when the mode is A/C or SIMV. Range: VC, PC, or VC+ New patient value: Neonatal: PC Pediatric/Adult: VC

Mode

New patient value: Neonatal: SIMV Pediatric/Adult: A/C

O2%

New patient value: Neonatal: 40% Pediatric/Adult: 100%

Neonatal: ≥ 0.5 kg (1.1 lb), ≤7.0 kg (15 lb) Pediatric: ≥ 3.5 kg (7.7 lb), ≤35 kg (77 lb) Adult: ≥ 7.0 kg (15 lb), ≤150 kg (330 lb) New patient value: Neonatal: 3.0 kg Pediatric: 15.0 kg Adult: 50 kg Resolution: 0.1 kg for 0.5 kg to 3.5 kg 0.5 kg for 3.5 kg to 10 kg 1.0 kg for 10 kg to 50 kg 5 kg for 50 kg to 100 kg 10 kg for 100 kg to 150 kg

Patient circuit type Range: Neonatal, Pediatric, or Adult. Neonatal is only available with the NeoMode option.

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Table 3: Ventilator settings updates Setting Peak flow (VMAX)

Function/Details Range:

Neonatal: ≥ 1.0 L/min, ≤30 L/min Pediatric: ≥ 3.0 L/min, ≤60 L/min Adult: ≥ 3.0 L/min, ≤150 L/min New patient value: Based on IBW Resolution: 0.1 L/min for flows of 1 L/min to 20 L/min 1 L/min for flows of 20 L/min and above

Respiratory rate (f)

Function: Sets the minimum number of mandatory breaths the patient receives per minute. Active in A/C, SIMV, and BiLevel Range: Neonatal: 1.0 /min to 150 /min Pediatric/Adult: 1.0 /min to 100 /min New patient value: Neonatal: 20 /min Pediatric: 14 /min Adult: 10/min Resolution: 0.1/min for 1.0 to 10 /min 1/min for 10 to 150 /min Accuracy: ± 0.1 (+0.6% of setting) 1 /min averaged over 60 s or 5 breaths, whichever occurs last

Spontaneous type

Function: Sets the type of spontaneous breath: pressure supported (PS), not pressure supported (NONE), Tube Compensated (TC), volume support (VS), or proportional assist (PA) TC is only available with the TC option when the patient circuit type is pediatric or adult VS is only available with the Volume Ventilation Plus option when the mode is SPONT PA is only available with the PAV+ option when the IBW ≥ 25.0 kg (patient type is Adult), tube I.D. ≥ 6.0 mm, and the mode is SPONT Range: Neonatal: PS, NONE, VS Pediatric: PS, NONE, TC, VS Adult: PS, NONE, TC, VS, PA

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Table 3: Ventilator settings updates Setting

Function/Details

Target volume (VT) Range: or Tidal volume (VT)

Neonatal: 5 mL to 315 mL Pediatric/Adult: 25 mL to 2500 mL (IBW-based range is 1.16 × IBW minimum; 45.7 × IBW maximum) New patient value: Neonatal: The greater of 5 mL or (7.25 × IBW) Pediatric/Adult: The greater of 25 mL or (7.25 × IBW) Resolution: 1 mL for 5 mL to 100 mL 5 mL for 100 mL to 400 mL 10 mL for 400 mL to 2500 mL

Trigger type

Range: Neonatal: Flow (V -TRIG) Pediatric/Adult: Pressure (P-TRIG) or V -TRIG New patient value: V -TRIG

Vent type

Range: INVASIVE or NIV (non-invasive) New patient value: INVASIVE

Table 4: Alarm settings updates Alarm

Range

High circuit pressure (2PPEAK)

New patient value: Neonatal: 30 cmH2O Pediatric/Adult: 40 cmH2O

High exhaled minute volume (2VE TOT)

Range: OFF or ≥ 0.10 L/min or > low exhaled minute volume limit, and Neonatal: ≤10 L/min Pediatric: ≤30 L/min Adult: ≤100 L/min New patient value: Based on IBW

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Table 4: Alarm settings updates (continued) Alarm

Range

High exhaled tidal Range: volume limit (2VTE)

OFF or > low exhaled spontaneous tidal volume limit > low exhaled mandatory tidal volume limit, and Neonatal: 5 mL to 500 mL Pediatric: 25 mL to 1500 mL Adult: 25 mL to 3000 mL New patient value: Based on IBW Resolution: 1 mL for 5 mL to 100 mL 5 mL for 100 mL to 400 mL 10 mL for 400 mL to 3000 mL

High respiratory rate (2fTOT)

Range:

Low exhaled mandatory tidal volume (4VTE MAND )

Range: OFF or ≥ 1 mL < high exhaled tidal volume limit and Neonatal: ≤300 mL Pediatric: ≤1000 mL Adult: ≤2500 mL New patient value (INVASIVE Vent Type): Based on IBW New patient value (NIV Vent Type): OFF Resolution: 1 mL for 1 mL to 100 mL 5 mL for 100 mL to 400 mL 10 mL for 400 mL to 2500 mL

OFF or Neonatal: 10 /min to 170 /min Pediatric/Adult: 10 /min to 110 /min New patient value: OFF Resolution: 1 /min

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Table 4: Alarm settings updates (continued) Alarm Low exhaled minute volume (4VE TOT)

Range Range: OFF or < high exhaled minute volume limit, and Neonatal: OFF or 0.01 L/min to 10 L/min Pediatric: 0.05 L/min to 30 L/min Adult: 0.05 L/min to 60 L/min New patient value (INVASIVE Vent Type): Based on IBW New patient value (NIV Vent Type): OFF Resolution: 0.005 L/min for 0.01 L/min to 0.50 L/min 0.05 L/min for 0.05 L/min to 5.0 L/min 0.5 L/min for 5.0 L/min to 60.0 L/min

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