Puritan Bennett 560 Ventilator Clinician’s Manual

Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B.4

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B.4.1

Monitored Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B.5

Range, Resolution, and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B.6

B–4

B.7

Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–8

B.8

USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–8

B.9

Pneumatic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–9

B.10 Manufacturer’s Declaration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–10

B.11 Standards Compliance and IEC Classification . . . . . . . . . . . . . . . . . . . . . . . .

B–14

C Theory of Operation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C–1

C.1 Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C–1

C.2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C–1

D Modes and Breath Types

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D–1

D.1 Modes of Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assist/Control (A/C) Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D.1.1

SIMV Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D.1.2

CPAP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D.1.3

PSV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D.1.4

D.2 Breath Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D–2

Clinician’s Manual

iii

Contents

D.2.1

Volume Breaths in Assist/Control Mode . . . . . . . . . . . . . . . . . . . . . . .

D–2

D.2.2

Pressure Control Breaths in Assist/Control Mode . . . . . . . . . . . . . . . .

D–3

D.2.3

Volume Breaths in V SIMV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D–4

D.2.4

Pressure Supported Breaths in SIMV and PSV Modes . . . . . . . . . . . . .

D–5

D.2.5

CPAP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D–6

D.3 Ventilation Modes and Apnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D–6

E Operational Verification Checklist

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E–1

F Alarms Tests

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–1

F.1

Low Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–1

F.2

Apnea Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–2

F.3

Power Failure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–2

F.4

Occlusion Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–2

F.5

High Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–3

F.6

Testing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–4

F.7

Involuntary Stop Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F–4

G Unpacking and Preparation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

G–1

H Parts and Accessories

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

H–1

I Glossary

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I–1

Index

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Index–1

Clinician’s Manual

Figures

Figure 1-1.

Locations of Labels – Top-Front View . . . . . . . . . . . . . . . . . . . . . . . .

1–15

Figure 1-2.

Locations of Labels – Front-Left View . . . . . . . . . . . . . . . . . . . . . . . .

1–16

Figure 1-3.

Location of Labels and Markings – Rear View. . . . . . . . . . . . . . . . . .

1–16

Figure 1-4.

Location of Labels – Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . .

1–17

Figure 2-1.

Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–4

Figure 2-2.

Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–5

Figure 2-3.

Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–6

Figure 2-4.

Ventilation Menu Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–7

Figure 2-5.

Alarm Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–8

Figure 2-6.

Waveforms Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–9

Figure 2-7.

USB Memory Device Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2–10

Figure 3-1.

Menus in PSV Mode with exhalation valve configuration . . . . . . . . . .

3–1

Figure 3-2.

Menus in PSV Mode with leakage configuration . . . . . . . . . . . . . . . .

3–1

Figure 3-3.

Exhalation Trigger Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–4

Figure 3-4.

Menus in CPAP Mode in leakage configuration . . . . . . . . . . . . . . . . .

3–7

Figure 3-5.

Menus in P A/C Mode with exhalation valve configuration . . . . . . . . .

3–9

Figure 3-6.

Menus in P A/C Mode with leakage configuration . . . . . . . . . . . . . . .

3–9

Figure 3-7.

Menus in the V A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–14

Figure 3-8.

Menus in P SIMV Ventilation Mode . . . . . . . . . . . . . . . . . . . . . . . . .

3–18

Figure 3-9.

Exhalation trigger sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–21

Figure 3-10. Menus in V SIMV Ventilation Mode . . . . . . . . . . . . . . . . . . . . . . . . .

3–23

Figure 3-11. Exhalation trigger sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–27

Figure 4-1.

Ventilation Menu: Pressure Leakage Configuration Modes (CPAP,

PSV S, PSV ST, PCV, P A/C). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–1

Figure 4-2.

Ventilation Menu: Pressure Valve Configuration Modes (PSV S, PSV ST, PCV,

P A/C)

4–1

Figure 4-3.

Ventilation Menu: Volume Mode (CV, V A/C, SIMV). . . . . . . . . . . . . .

4–2

Figure 4-4.

Alarm Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV,

P A/C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–2

Figure 4-5.

Alarm Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C) . . . .

4–2

Figure 4-6.

Alarm Menu: Volume Modes (CV, V A/C, SIMV). . . . . . . . . . . . . . . . .

4–2

Figure 4-7.

Waveform Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST,

PCV, P A/C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–3

Figure 4-8.

Waveform Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C) .

4–3

Figure 4-9.

Waveform Menu: Volume Mode (CV, V A/C, SIMV) . . . . . . . . . . . . . .

4–3

Figure 4-10. Monitored Parameter Inserts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–3

Figure 4-11. Display Showing Unavailable Parameter Values . . . . . . . . . . . . . . . . .

4–4

Figure 4-12. Inspiratory Effort Detected Indicator. . . . . . . . . . . . . . . . . . . . . . . . . .

4–4

Figure 4-13. Bargraph Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–6

Figure 4-14. Waveform Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–6

Figure 4-15. Ventilation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–7

Figure 5-1.

Alarm Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–2

Figure 5-2.

Accessing Alarm Logs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–3

Figure 5-3.

Displaying the Alarm Logs Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–3

Clinician’s Manual

Figures

Figure 5-4.

Alarm Logs Display when No Alarm Activated . . . . . . . . . . . . . . . . . .

5–3

Figure 5-5.

Silencing the Audible Portion of Alarms. . . . . . . . . . . . . . . . . . . . . . .

5–4

Figure 5-6.

Manually Pausing Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–5

Figure 5-7.

Reactivating Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–6

Figure 5-8.

Alarm Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–6

Figure 6-1.

The Power Cable Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–2

Figure 6-2.

Inserting the Power Cable Holder Into the Notch . . . . . . . . . . . . . . . .

6–3

Figure 6-3.

Power Cable Connected to the Ventilator . . . . . . . . . . . . . . . . . . . . .

6–3

Figure 6-4.

Power Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–4

Figure 6-5.

Connecting the Ventilator to an External DC Power Source . . . . . . . .

6–5

Figure 6-6.

Connecting the DC Power Cable to the Ventilator. . . . . . . . . . . . . . .

6–5

Figure 6-7.

Single Limb Patient Circuit With Exhalation Valve . . . . . . . . . . . . . . .

6–7

Figure 6-8.

Double Limb Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–8

Figure 6-9.

Close-up of Exhalation Valve Tube and Proximal Pressure Tube . . . . .

6–9

Figure 6-10. Single limb Patient Circuit Without Exhalation Valve . . . . . . . . . . . . .

6–9

Figure 6-11. Air Inlet Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–11

Figure 6-12. Bacteria Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–11

Figure 6-13. Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–12

Figure 6-14. Removing the Exhalation Block . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–13

Figure 6-15. Rear Panel Oxygen Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–15

Figure 6-16. Connecting the Oxygen Supply System . . . . . . . . . . . . . . . . . . . . . .

6–15

Figure 6-17. Disconnecting the Oxygen Supply System . . . . . . . . . . . . . . . . . . . .

6–16

Figure 6-18. Connecting the FIO

sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–17

Figure 6-19. Using the Dual Bag Accessory . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6–18

Figure 6-20. Connecting the Nurse Call Cable. . . . . . . . . . . . . . . . . . . . . . . . . . .

6–20

Figure 7-1.

Turning on the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–2

Figure 7-2.

Welcome Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–2

Figure 7-3.

Ventilation Menu Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–3

Figure 7-4.

Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–3

Figure 7-5.

Absolute and Relative Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–6

Figure 7-6.

E Sens Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–7

Figure 7-7.

Resetting Patient Hours to Zero (1) . . . . . . . . . . . . . . . . . . . . . . . . . .

7–8

Figure 7-8.

Resetting Patient Hours to Zero (2) . . . . . . . . . . . . . . . . . . . . . . . . . .

7–8

Figure 7-9.

Resetting Patient Hours to Zero (3) . . . . . . . . . . . . . . . . . . . . . . . . . .

7–9

Figure 7-10. Resetting Patient Hours to Zero (4) . . . . . . . . . . . . . . . . . . . . . . . . . .

7–9

Figure 7-11. Selecting the Preferences Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–10

Figure 7-12. Changing Settings in the Preferences Menu . . . . . . . . . . . . . . . . . .

7–10

Figure 7-13. Setting the Apnea Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–14

Figure 7-14. Accessing the Ventilation Report . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–16

Figure 7-15. Changing Ventilation Modes While on Standby. . . . . . . . . . . . . . . .

7–17

Figure 7-16. Changing Ventilation Modes During Ventilation (1) . . . . . . . . . . . . .

7–17

Figure 7-17. Changing Ventilation Modes During Ventilation (2) . . . . . . . . . . . . .

7–18

Figure 7-18. Changing Ventilation Modes During Ventilation (3) . . . . . . . . . . . . .

7–18

Figure 7-19. Changing Ventilation Modes During Ventilation (4) . . . . . . . . . . . . .

7–19

Figure 7-20. Modifying a Ventilation Parameter . . . . . . . . . . . . . . . . . . . . . . . . .

7–20

Figure 7-21. Setting Links Between Ventilation Parameters . . . . . . . . . . . . . . . . .

7–21

Clinician’s Manual

Figures

Figure 7-22. Modifying Alarm Parameters – Min Value . . . . . . . . . . . . . . . . . . . .

7–22

Figure 7-23. Modifying Alarm Parameters – Max Value . . . . . . . . . . . . . . . . . . . .

7–23

Figure 7-24. Selecting the USB Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–24

Figure 7-25. Selecting Transfer Continuously . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–25

Figure 7-26. Selecting Transfer Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–26

Figure 7-27. Erasing Data from the USB Memory Device . . . . . . . . . . . . . . . . . . .

7–27

Figure 7-28. Installing the Locking Key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–28

Figure 7-29. Prompt to Start Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–29

Figure 7-30. Starting Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–30

Figure 7-31. Stopping Ventilation (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–30

Figure 7-32. Stopping Ventilation (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–31

Figure 8-1.

Internal Battery Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8–3

Figure 8-2.

Battery Reserve Capacity as a Percentage . . . . . . . . . . . . . . . . . . . . . .

8–3

Figure 8-3.

Battery Reserve Capacity in Hours and Minutes . . . . . . . . . . . . . . . . .

8–3

Figure 8-4.

Power Indicators When Charging the Battery . . . . . . . . . . . . . . . . . . .

8–5

Figure 10-1. Blocking the Patient Wye (Double-Limb Circuit Shown) . . . . . . . . . .

10–1

Figure 10-2. Calibrating the Exhalation Flow Sensor (1) . . . . . . . . . . . . . . . . . . . .

10–2

Figure 10-3. Calibrating the Exhalation Flow Sensor (2) . . . . . . . . . . . . . . . . . . . .

10–2

Figure 10-4. Calibrating the Exhalation Flow Sensor (3) . . . . . . . . . . . . . . . . . . . .

10–2

Figure 10-5. Calibrating the FIO

sensor (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10–4

Figure 10-6. Calibrating the FIO

Sensor (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10–4

Figure 10-7. Calibrating the FIO

Sensor (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10–5

Figure 10-8. Calibrating the FIO

Sensor (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10–5

Figure 10-9. Replacing the Air Inlet filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10–6

Figure C-1.

Gas Delivery System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C–2

Figure F-1.

Blocking the Patient End of a Single Limb Circuit . . . . . . . . . . . . . . . .

F–3

Figure G-1.

Puritan Bennett™ 560 Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . .

G–2

Figure G-2.

Dual Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

G–2

Clinician’s Manual

vii

This page intentionally blank.

viii

Clinician’s Manual

Tables

Table 1-1.

Ventilator Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1–10

Table 1-2.

Ventilator Labels and Markings . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1–14

Table 3-1.

Ventilation Parameters in PSV Menu . . . . . . . . . . . . . . . . . . . . . . . . .

3–2

Table 3-2.

Alarm Parameters in PSV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–2

Table 3-3.

Ventilation Parameters in CPAP Menu . . . . . . . . . . . . . . . . . . . . . . . .

3–7

Table 3-4.

Alarm Parameters in CPAP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–7

Table 3-5.

Ventilation Parameters in P A/C Mode Menu . . . . . . . . . . . . . . . . . .

3–10

Table 3-6.

Alarm Parameters in P A/C Mode . . . . . . . . . . . . . . . . . . . . . . . . . .

3–10

Table 3-7.

Ventilation Parameters in V A/C Ventilation Mode . . . . . . . . . . . . . .

3–14

Table 3-8.

V A/C Mode Alarm Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3–14

Table 3-9.

Ventilation Parameters in P SIMV Ventilation Mode . . . . . . . . . . . . .

3–18

Table 3-10.

Alarm Parameters in P SIMV Ventilation Mode . . . . . . . . . . . . . . . .

3–19

Table 3-11.

Ventilation Parameters in V SIMV Mode . . . . . . . . . . . . . . . . . . . . .

3–23

Table 3-12.

Alarm Parameters in the V SIMV Mode Menu . . . . . . . . . . . . . . . . .

3–24

Table 4-1.

Displayed Monitored Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4–4

Table 5-1.

Overview of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–7

Table 5-2.

Alarms and Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5–14

Table 5-3.

Additional Troubleshooting and Corrective Actions . . . . . . . . . . . . .

5–24

Table 7-1.

Languages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–5

Table 7-2.

USB Memory Device Specifications. . . . . . . . . . . . . . . . . . . . . . . . . .

7–24

Table 7-3.

Time taken to transfer trends data from the ventilator to a USB memory device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7–27

Table 8-1.

Internal Battery Reserve Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8–2

Table 9-1.

Approved Cleaning Solutions for Exterior Ventilator Surfaces . . . . . .

9–2

Table 10-1.

Consumables and Replacement Intervals . . . . . . . . . . . . . . . . . . . . .

10–7

Table A-1.

Patient/Caregiver Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A–1

Table B-1.

Physical Description (Excluding Accessories) . . . . . . . . . . . . . . . . . . . .

B–1

Table B-2.

AC Electrical Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–1

Table B-3.

Internal Lithium Ion Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–2

Table B-4.

Remote Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–2

Table B-5.

Power Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–3

Table B-6.

Alarm Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–3

Table B-7.

Audio Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–3

Table B-8.

Performance Parameter Specifications and Tolerances . . . . . . . . . . . .

B–3

Table B-9.

Monitored Parameter Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–3

Table B-10.

Ventilator Range, Resolution, and Accuracy . . . . . . . . . . . . . . . . . . . .

B–4

Table B-11.

Environmental Conditions for Storage or Transport . . . . . . . . . . . . . .

B–8

Table B-12.

Environmental Conditions for Operation . . . . . . . . . . . . . . . . . . . . . .

B–8

Table B-13.

USB Memory Device Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . .

B–8

Table B-14.

Data Transfer Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–8

Table B-15.

Airway Resistances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–9

Table B-16.

Patient Circuit Resistances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–9

Table B-17.

Air Inlet Resistance (Filter) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–9

Table B-18.

Oxygen Inlet Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–9

Clinician’s Manual

Tables

Table B-19.

Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–9

Table B-20.

Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–10

Table B-21.

Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B–11

Table B-22.

Electromagnetic Immunity – Conducted and Radiated RF . . . . . . . .

B–12

Table B-23.

B–13

Table B-24.

Compliant Cables and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . .

B–14

Table E-1.

Operational Verification Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . .

E–1

Table H-1.

List of Consumables and Accessories . . . . . . . . . . . . . . . . . . . . . . . . .

H–1

Table H-2.

List of Circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

H–2

Clinician’s Manual

Preface

Purpose of This Manual

This manual contains important information regarding the safe operation of your Puritan Bennett™

560 Ventilator. Your ventilator is an electrical device that can provide years of useful service with the proper care, as described in this manual.

Ensure that you read and understand the instructions contained in this manual before operating the ventilator.

Warning

Before operating the ventilator, read, understand, and strictly follow the information contained

in Chapter 1, “Safety Information” .

Qualification of Personnel

Installation and maintenance of the device must be made by authorised and trained personnel. In particular, training for the handling of products sensitive to electrostatic discharges must include the use of Electrostatic Discharge (ESD) protection devices and knowledge of the following symbol’s meaning: , as well as using original spare parts and respecting quality assurance and traceability rules approved by Covidien.

Warranty

Information regarding your product warranty is available from your sales representative or

Covidien.

Extended Service

The Puritan Bennett 560 Ventilator offers extended service contracts/warranties for purchase when the ventilator is purchased. Please contact your local Covidien Sales or Service Representative for additional information.

For online technical support, visit the SolvIT

Center Knowledge Base by clicking the link at http://www.covidien.com. Here, you will find answers to frequently asked questions about the product and other Covidien products 24 hours a day, 7 days a week. If you require further assistance, contact your local Covidien representative.

Preface

Technical Support

Technical Service Contacts:

Covidien Argentina

Aguero 351

Capital Federal - 1171 ABC,

Argentina

Tel: (5411) 4863-5300

Fax: (5411) 4863-4142

Covidien Belgie S.A.-N.V.

Generaal De Wittelaan 9/5

Mechelen

2800

België

Tel +32 152 981 37

Fax +32 152 167 83

Covidien Chile

Rosario Norte 530, Piso 12

Las Condes

Santiago de Chile, Chile

Tel: (562) 231-3411

Fax: (562) 231-3527

Covidien Czech Republic

Vyskocilova 1410/1

140 00

Praha

Ceska Republika

Tel +42 024 109 57 35

Fax + 42 02 3900 0437

Covidien ECE

Galvaniho 7/a

821 04 Bratislava

Slovenska Republika

Tel +42 124 821 45 73

Fax +42 124 821 45 01

Covidien Hellas SA

8 Fragoklisias Street

Maroussi, 151 25

Greece

Tel +30 211 180 36 00

Fax +30 210 614 63 80

Covidien Australia

52A Huntingwood Drive

Huntingwood, NSW 2148

Australia

Telephone (+61) 1800 350702

Fax +612 9671 8118

Covidien Brazil

Av. Nações Undias 23013-A

Vila Almeida

São Paulo, SP

Brasil 04795-100

Tel: (5511) 5683-8300

Fax: (5511) 5683-8349

Covidien Colombia

Edificio Prados de la Morea

Carretera Central Del Norte

(Cra 7a) Kilometro 18,

Chia-Cundinamarca

Bogota, Colombia

Tel: (571) 619-5469

Fax: (571) 619-5425

Covidien Danmark A/S

Langebrogade 6E, 4. sal

1411 København K

Danmark

Tel +45 702 753 50

Fax:+45 702 756 50

Covidien Finland Oy

Läkkisepäntie 23

00620 Helsinki

Finland

Te. +35 896 226 84 10

Fax +35 896 226 84 11

Covidien Hungary

1095 Budapest

Mariassy u. 7

Magyarorszag

Hungary

Tel + 36 1880 7975

Fax + 36 1777 4932

Covidien Austria GmbH

Campus21

Europaring F09402

Brunn am Gebrige

A-2345 Österreich

+43 223 637 88 39

+43 223 637 88 39 40

Covidien Canada

19600 Clark Graham

Baie d'Urfe, QC, H9X 3R8

Canada

Tel:1-514-695-1220, Ext.4004

Fax: 1-514-695-4965

Covidien Costa Rica

La Uruca 75 Metros al Oseste de

Faco

Oficentro La Virgen, Edificio "I"

San Jose, Costa Rica

Tel: (506) 256-1170

Fax: (506) 256-1185

Fax: (506) 290-8173

Covidien Deutschland GmbH

Technisches Service Center

Raffineriestr. 18

93333 Neustadt / Donau

Germany

Tel + 49 944 595 93 80

Fax + 49 944 595 93 65

Covidien France SA

Parc d’affaires Technopolis

Bat. Sigma, 3 Avenue du

Canada

LP 851 Les Ulis

91975 Courtaboeuf Cedex

France

Tel +33 169 821 400

Fax +33 169 821 532

Covidien Ireland Commercial

Ltd

Block G, Ground Floor,

Cherrywood Technology Park,

Loughlinstown

County Dublin

Ireland

Tel +353 1 4381613

xii

Clinician’s Manual

Preface

Technical Service Contacts:

Covidien Israel

5 Shacham St.

North Industrial Park

Caesarea

38900 Israel

Tel +97 246 277 388

Fax+97 266 277 688

Covidien Mexico

Calz.Ermita Iztapalapa 1514

Col. Barrio San Miguel

Del. Iztapalapa

Mexico, D.F. 09360 Mexico

Tel: (5255) 5804-1524

Fax: (5255) 5685-1899

Covidien Panama

Parque Industrial Costa del Esta

Calle Primera, Edifio # 109

Panama City, Panama

Tel: (507) 264-7337

Fax: (507) 236-7408

Covidien Puerto Rico

Palmas Industrial Park

Road 869 Km 2.0 Bdlg. #1

Cataño, PR 00962

Tel. 787-993-7250

Ext. 7222 & 7221

Fax 787-993-7234

Covidien South Africa

Corporate Park North

379 Roan Crescent

Randjespark

Midrand, South Africa

Tel +27 115 429 500

Fax +27 115 429 547

Covidien Switzerland

Roosstr. 53

Wollerau

8832

Schweiz

Tel +41 17865050

Fax +41 17865010

Covidien Italia S.p.A.

Via Rivoltana 2/D

20090 Segrate

Italy

Tel +39 027 031 72 61

Fax +39 027 031 72 84

Covidien Nederland BV

Hogeweg 105

5301 LL Zaltbommel

Nederland

Tel +31 41 857 66 68

Fax +31 41 857 67 96

Covidien Polska

Al. Jerozolimskie 162

Warszawa. 02-342

Polska

Tel +48 223 122 130

Fax +48 223 122 020

Covidien Russia

53 bld. 5 Dubininskaya Street

Moscow

RUSSIA. 119054 Poccии

Tel +70 495 933 64 69

Fax +70 495 933 64 68

Covidien Spain S.L.

c/Fructuós Gelabert

6, pl. Sótano

08970 Sant Joan Despí

Barcelona, Spain

Tel +34 93 475 86 69

Fax +34 93 373 87 10

Covidien UK & Ireland

Unit 2, Talisman Business Park

London Road, Bicester

OX26 6HR, United Kingdom

Tel +44(0)1869 328092

Fax +44(0)1869 327585

Covidien Japan Inc.

Technical Support Center

83-1, Takashimadaira 1-Chome

Itabashi-ku, Tokyo 175-0082

Japan

Tel: +81 (0) 3 6859 0120

Fax: +81 (0) 3 6859 0142

Covidien Norge AS

Postboks 343

1372 Asker.

Norway

Tel +47 668 522 22

Fax +47 668 522 23

Covidien Portugal Lda.

Estrada do Outeiro de Polima,

Lote 10-1° Abóboda

2785-521 S.Domingos de Rana

Portugal

Tel +35 121 448 10 36

Fax +35 121 445 1082

Covidien Saglik A.S.

Maslak Mahallesi Bilim Sokak

No: 5, Sun Plaza Kat: 2-3

Sisli, Istanbul 34398

Turkey

Tel +90 212 366 20 00

Fax +90 212 276 35 25

Covidien Sverige AB

Box 54

171 74 Solna

Sweden

Tel +46 858 56 05 00

Fax + 46 858 56 05 29

Covidien Singapore

Singapore Regional Service

Centre

15 Pioneer Hub, #06-04

Singapore 627753

Tel (65) 6578 5187 / 8 / 9

Fax (65)6515 5260.

Email:

[email protected]

Clinician’s Manual

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xiv

Clinician’s Manual

1 Safety Information

1.1 Definitions

This manual uses three indicators to highlight critical information: Warning, Caution, and Note.

They are defined as follows:

Warning

Indicates a condition that can endanger the patient or the ventilator operator.

Indicates a condition that can damage the equipment.

Note:

Indicates points of particular emphasis that make operation of the ventilator more efficient or convenient.

It is essential to read, understand and follow these instructions before using the Puritan Bennett™

560 Ventilator.

In order to use the ventilator correctly and efficiently and to help prevent incidents, please pay particular attention to section 1.2,

“Warnings” , as well as all warnings and cautions contained

throughout this manual.

1.2 Warnings

General Warnings Regarding Use

• The ventilator must be used only under the responsibility and on the prescription of a doctor.

• The ventilator must be used according to its intended use. Refer to section 2.1, “Indications for

Use” .

• Be aware this manual describes how to respond to ventilator, but it does NOT tell you how to respond to the patient.

• While the ventilator is in use, an alternative means of ventilation should always be available in the event of a ventilator problem. This is particularly true for ventilator-dependent patients.

Supplementary observation, appropriate for the patient's condition, is also recommended.

• To ensure that ventilation continues uninterrupted, ensure alternative power sources are available (AC power source, extra batteries, or an auxiliary DC car adapter). Be prepared for the possibility of power failure by having an alternative means of ventilation ready for use – particularly for ventilator-dependent patients.

• Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of exhalation gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death.

Safety Information

• The ventilator must not be used with flammable anesthetic substances.

• Do not start ventilation until you ensure that the device is suitably assembled, that the air inlet filter is properly installed and is not obstructed, and that there is proper clearance all around the unit. Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient circuit, including all hoses, is not damaged or obstructed.

• A ventilator-dependent patient should always be monitored by trained and competent medical personnel. Ensure that the patient’s caregiver is able and prepared to take suitable action in the event the ventilator identifies an alarmed condition or experiences a problem.

• Do not use a patient circuit with a leak accessory for ventilator-dependent patients.

• Before dispensing the ventilator to caregivers or the patient for home use, ensure the Locking

Key is activated so that critical ventilator settings are not modified.

• Do not perform ventilator alarm tests while the patient is connected to the ventilator. Provide the patient with an alternate means of ventilation before conducting these tests.

• Verify the functionality of the alarm conditions before connecting the patient to the ventilator.

Refer to chapter F, “Alarms Tests”

• If the ventilator fails the alarm tests or if you cannot complete the tests, refer to chapter 5.8,

“Troubleshooting”

or call your equipment supplier or Covidien.

• When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator.

• A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, ventilation will resume without having to press the VENTILATION ON/OFF button.

• To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories.

• A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet – or both ports if a double-limb circuit is used – is recommended. Refer to

chapter 9, “Cleaning” .

• Handle the ventilator with care during and after use, particularly when ambient temperatures are high. Some ventilator surfaces may become hot, even if safety specifications are not exceeded.

Warnings Regarding Installation and Environment of Use

• Even though the Puritan Bennett™ 560 Ventilator meets current safety standards, the internal

Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to be

Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the

Puritan Bennett 560 Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA: International

Air Transport Association), International Maritime Dangerous Goods code for sea and the

European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements apply. For air transport; the Puritan Bennett 560

Ventilator is permitted as checked-in or carry-on baggage. Two spare batteries per person may be taken on board as carry-on luggage only, with the prior approval of the airline. This classification and regulatory requirements may vary depending upon the country and mode of transport.

Therefore it is recommended that users verify with the carrier / airline as to which measures to take before the voyage.

• To minimise the risk of damage, you must use the ventilator’s Dual Bag to transport the

ventilator. See Table H-1, List of Consumables and Accessories

• Regularly clean the ventilator’s Dual Bag according to manufacturer’s recommendations.

1-2

Clinician’s Manual

Safety Information

• The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately.

• To avoid damage to the ventilator, in particular the batteries or electrical components, fluids must not be allowed to enter the device, particularly through the air inlet filter or the cooling apertures located in the side, rear, and bottom panels of the ventilator.

• To ensure correct and lasting operation of the device, ensure that the ventilator is installed and

operated in the environmental conditions recommended in Appendix B, “Specifications” .

• Do not leave power cables lying on the ground where they may pose a hazard.

• Do not operate the ventilator in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device.

• Avoid using the ventilator, if possible, in dusty environments. Dusty environments may require more vigilant monitoring, cleaning, and/or replacement of air intake and other filters.

• Ensure that the ventilator’s immediate surroundings allow for the proper operational connection of the device without folding, pinching, or damaging any of the required cables or tubes, and that the connection of the to the patient provides for a secure, comfortable fit.

• Place the ventilator in a safe place when ventilating and according to the recommendations in this manual.

• Do not place the ventilator in a position where a child can reach it or in any position that might cause it to fall on the patient or someone else.

• To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes

(main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains.

• If the ventilator has been transported or stored at a temperature that differs more than ± 20 °C

(± 36 °F) from the temperature in which it will be operating, the ventilator should be allowed to stabilise in its operating environment for at least two (2) hours prior to use.

• If the ambient temperature where the device is operated is greater than 35 °C (95 °F), the flow supplied at the device outlet may exceed 41 °C (106 °F). This may lead to undesirable side effects for the patient. To avoid injury to the patient move the patient and the ventilator to a cooler location. For more information, contact Covidien.

• The default setting for altitude compensation is YES. Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations.

• To reduce the risk of a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (such as flammable anesthetics and/or heaters) away from the ventilator and oxygen hoses.

• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If

necessary, replace the filter before the recommended replacement period is over (see chapter 10,

“Routine Maintenance” ). This is particularly important when the ventilator is installed on a

wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.

• Handle the ventilator with care during and after use, particularly when ambient temperatures are high. Some ventilator surfaces may become hot, even if safety specifications are not exceeded.

Warnings Regarding Electrical Power Supplies

• Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off.

• The operator should connect the ventilator to an AC power source whenever available, for safer operation.

• The maximum recommended shelf life of the internal battery is two (2) years. Do not use a battery that has been stored for two years prior to its first use.

Clinician’s Manual

1-3

Safety Information

• Periodic recharging is important to help maximize useful life of the battery. Do not store the internal battery for extended periods, without recharging, as this may reduce the maximum life.

• For the AC (“mains”) power cable to be properly secured, the attachment located on the power cable must be fitted into the power cable holder incorporated in the battery access cover and

located under the AC (mains) power socket. Refer to section 6.2, “Connecting to External AC

Power” .

• The power supply to which the ventilator is connected (both AC and DC) must comply with all applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear of the ventilator to ensure correct operation. Refer also to the electrical

specifications found in Appendix B, “Specifications”

• Ensure that the ventilator’s internal battery is fully charged before connecting the ventilator to an external DC power source. Powering the ventilator using an external 12– 30 VDC power source (via the DC power cable) does not enable its internal battery to recharge.

• Due to its limited internal battery’s reserve capacity, the ventilator should only be operated on the internal battery when no other power source is available. Ensure that the internal battery never becomes fully discharged.

• When using a car auxiliary adapter (cigarette lighter) ensure the car has been started prior to

plugging in the ventilator’s DC adapter. Refer to chapter 6.3, “Connecting to an External DC

Power Source”

• Even if the “INTERNAL BATTERY” charging indicator is off, charging of the battery may sometimes be incomplete if the ambient temperature is above 40 °C (104 °F) because of the battery’s internal heat safety device.

• When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.

• Batteries should be disposed of according to environmental legislation in your country and locality.

• Never expose any batteries to direct flame.

• Ensure that the AC power cable is in perfect condition and not compressed. The device should not be turned on if the AC power cable is damaged.

Warnings Regarding Hoses and Accessories

• The ventilator must not use, nor be connected to, any anti-static or electrically conductive hoses, tubing, or conduits.

• Minimum and maximum VTE alarm parameters must be properly set to warn in the event of patient disconnection.

• Before opening the packaging for the Patient Circuit, ensure that no damage is evident to the packaging or its contents. Do not use if evidence of damage exists.

• The patient circuit should not be changed during ventilation.

• On a DAILY basis, inspect the patient circuit to ensure that it shows no signs of damage, is properly connected, and is operating correctly without leakage.

• Single Use accessories should not be reused.

• The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilised. To maintain good measurement quality when

used continuously, clean the exhalation block periodically (refer to section 9.3, “Cleaning the

Exhalation Block”

). The exhalation block should be changed every 4 months and cannot be reused with any other patient.

• During invasive ventilation (when an artificial airway bypasses the patient’s upper respiratory system), the patient’s upper respiratory system cannot humidify the incoming gas. For this reason, the use of a humidifier, to minimise drying of the patient’s airway and subsequent irritation and discomfort, must be used.

1-4

Clinician’s Manual

Safety Information

• If exhaled tidal volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must be used in order to detect leaks. In this case, both the minimum and maximum VTE alarm parameters must be properly set to warn in the event of patient disconnection.

• Failing to replace a dirty air inlet filter, or operating the ventilator without a filter, may cause serious damage to the ventilator.

• Before cleaning the ventilator, first disconnect the ventilator and the patient circuit.

• If the ventilator is used indoors, the condition of the air inlet filter should be checked monthly. If the ventilator is used outdoors or in a dusty environment, the filter should be checked weekly and replaced as necessary.

• The air inlet filter is not reusable; do not attempt to wash, clean, or reuse it.

• The patient circuit should always be positioned to avoid hindering the patient's movements, to prevent accidental disconnection or leakage, and to minimise the risk of patient strangulation.

• For pediatric use, ensure that the patient circuit type fits, and, in all respects, is suitable for use with a child. Use a pediatric circuit for patients that weigh under 53 lb. (23 kg). To ensure proper

performance of the ventilator, See Table H-2, List of Circuits , on page H-2, for a list of

recommended patient circuits.

• Resistance of the exhalation valve and accessories (water traps, filters, HMEs etc) must be as low as possible.

• Adding attachments to the ventilator breathing system can cause the pressure during exhalation at the patient connection port to increase.

• The exhalation valve must allow rapid discharge of the circuit pressure. Ensure that the exhalation valve is always clean and its evacuation aperture (exhaust port) is never obstructed.

• Users must always possess an additional breathing circuit and exhalation valve while using the

Puritan Bennett™ 560 Ventilator.

• Always ensure that the humidification device is positioned lower than both the ventilator and the patient. Use water traps, if necessary, to limit water in the patient circuit and periodically empty these water traps.

• If a heated humidifier is used, you should always monitor the temperature of the gas delivered to the patient. Gas delivered from the ventilator that becomes too hot may burn the patient's airway.

• Adding accessories to the ventilator breathing circuit, such as a humidifier and water trap(s), may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory. Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration.

• The level of inspiratory resistance of the circuit and accessories (bacteria filter, humidifier, HMEs etc) must be as low as possible. Settings – particularly the PATIENT DISCONNECTION alarm, maximum inspired volume (Max VTI), and minimum inspired volume (Min VTI) settings – must be periodically adjusted according to changes in the patient circuit resistance – especially when filters are replaced.

• To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien

in this manual; refer to chapter 6, “Installation and Assembly” and

Appendix H, “Parts and

Accessories”

. The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 1.1 metres (3.6 feet) to 2.0 metres (6.6 feet). The tubing must conform to all applicable standards and must be fitted with Ø 22 mm terminals that also conform to all applicable standards. Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume: a corrugated tube of Ø 22 mm for adult patients, and a corrugated tube of Ø 15 mm for pediatric patients with a tidal volume lower than

200 ml.

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1-5

Safety Information

• To ensure proper performance of the ventilator, use only accessories (including oxygen

accessories) approved and recommended by Covidien. See Appendix H, “Parts and Accessories”

or contact your customer services.

• When using non-invasive ventilation (NIV) without an exhalation valve, use a vented nose or face mask or a non vented combined with a leak accessory. When using non-invasive ventilation

(NIV) with an exhalation valve, use a non-vented mask.

• Before using the Nurse Call system, ensure that its connections are secure and it operates properly. For more information, contact Covidien.

• To connect the ventilator to a Nurse Call device, contact Covidien to check the ventilator's compatibility with the Nurse Call device and order a suitable connection cable.

• Do not use Nurse Call devices that operate based on the closure of an electrical circuit, because the devices often do not take into account possible cable disconnection or a total loss of power.

Ensure that the Nurse Call device is always connected to the ventilator.

Warnings Regarding Settings:

• Before starting ventilation, always verify that all settings are properly set in accordance with the required prescription.

• Before starting ventilation, ensure that the device is properly assembled and that the air inlet, cooling vents, and alarm sound diffusion holes are not obstructed. Ensure also that the patient circuit is of the proper configuration (double or single limb), properly connected to the ventilator, and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies.

• The CPAP mode does not provide a set respiratory rate. Do not use this mode for ventilatordependent patients.

• Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of exhalation gas, primarily carbon dioxide, may be inhaled by the patient.

• Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. The audible alarm vents located at the front of the device should never be obstructed. The alarm can be paused with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared.

• Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths.

• Monitor the patient's state of health in order to ensure that the ventilator’s settings are always suited to the patient’s current physiological requirements.

• In adult or pediatric use ensure that the adjusted tidal volume is compatible with the needs of the patient.

• When changing the mode during ventilation, significant transitions of pressure, flow or cycling rate might occur, depending on the difference between the modes. Before setting the new mode, first ensure that the settings between the different modes are compatible. This reduces the risk of discomfort and harm to the patient.

• Do not conduct the ventilator alarm test while the patient is connected to the ventilator. Switch the patient to an alternate means of ventilation before testing.

• The setting of the Low PIP alarm must be adjusted for the patient, but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly. Perform the Low

Pressure Test (refer to section F.1, “Low Pressure Test”

) to ensure the Low PIP alarm is properly set.

• If APNEA TIME is set to a value higher than 60/Control R then the APNEA alarm will not activate.

• If an APNEA alarm is required, set the APNEA setting to YES in the Preferences Menu.

• The Apnea Alarm should be set to YES for ventilator dependant patients.

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Clinician’s Manual

Safety Information

• Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction.

• Ensure the Insp Time setting is compatible with the physiological requirements of the patient.

• Adjustable alarms should not be systematically cancelled; instead, they should be adjusted according to the needs and condition of the patient.

• A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, the ventilation will resume without having to press the VENTILATION ON/OFF button.

• In the SIMV mode the use of a double limb circuit is recommended. The Min VTE setting should remain active in the event that pressure losses are present on the patient circuit downstream from the proximal pressure link. In such cases the “PATIENT DISCONNECTION” alarm would not be systematically activated in case of a disconnection of the circuit.

• The inspiration trigger threshold should be carefully modified in order to avoid the risk of false triggering or “autotriggering” of the ventilator. For example, Level 1P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.

• The sound level of the alarms should be adjusted according to the installation environment and the size of the area monitored by the patient’s caregiver. Ensure that the alarm sound apertures at the front of the device are never obstructed.

Warnings Regarding USB Memory Device

• Always verify the file ID before using a USB memory device to transfer data between the ventilator and a PC.

Warnings Regarding Maintenance

• Never use a ventilator or any components or accessories that appear to be damaged. If any signs of damage are evident, contact your equipment supplier or Covidien.

• To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator, only personnel authorised and qualified by Covidien should attempt to service or make authorised modifications to the Puritan Bennett™ 560 Ventilator.

• If you cannot determine the cause of a problem with your ventilator, contact your equipment supplier. Do not use the ventilator until the problem has been corrected.

• To ensure proper performance of the ventilator, the preventative maintenance schedule should be followed. For further information contact Covidien.

• On a daily basis, ensure the proper connection and operation of the patient circuit.

• If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER.

If necessary, remove the patient from the ventilator and provide an alternative means of ventilation.

• After assembling, cleaning, or reassembling the patient circuit, and on a daily basis, inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure.

• Use all cleaning solutions and products with caution. Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator. Use only those solutions listed in

Table 9-1

• Never use a liquid cleaner inside the patient circuit, or on any component of a gas pathway.

Clean the patient circuit only as specified by the manufacturer's instructions.

• Do not attempt to open, repair or otherwise service the ventilator yourself. Doing so might endanger the patient, damage the ventilator, and/or void your warranty. Only personnel authorised and qualified by Covidien should repair, open or service the ventilator.

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1-7

Safety Information

• If the ventilator is damaged or its external housing is not correctly closed or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odor, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.

• The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilised. To maintain good measurement quality when

used continuously, clean the exhalation block periodically (refer to section 9.3, “Cleaning the

Exhalation Block”

). The exhalation block should be changed every 4 months and cannot be reused with any other patient.

• Ensure that the exhalation block is completely dried after cleaning and prior to use.

• When an exhalation block is set up, each time it is removed, or after installing a new exhalation block on the machine, it is essential that the exhalation flow sensor be recalibrated before the

exhalation block is used. Refer to section 10.1, “Calibrating the Exhalation Flow Sensor”

• The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer’s recommendations and according to the patient circuit lifetime.

Refer to the instructions for use supplied by the manufacturer of the patient circuit (included

with the ventilator) and chapter 6, “Installation and Assembly” .

chapter 9, “Cleaning” .

• Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If

necessary, replace the filter before the recommended replacement period is over (see chapter 10,

“Routine Maintenance”

). This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly.

• For environmental protection, the ventilator and its components, whatever their respective conditions of operation, cannot be disposed of with household waste and must be submitted for suitable selective collection and possible recycling. Observe all applicable regulations when disposing of the ventilator and any of its components.

• If the device is damaged, its external housing is not correctly closed, or it behaves in a way that is not described in this manual (excessive noise, heat emission, unusual odour, alarms not triggered during the start-up procedure), the oxygen and power supplies should be disconnected and use of the device stopped immediately.

• Before using the ventilator’s internal battery, ensure that the battery is fully charged and that the charge holds. Back up ventilators or those in storage should be connected to an AC power source to protect the integrity of the battery.

• The maximum recommended shelf life of the internal battery is two (2) years. Do not use a battery that has been stored for two years prior to its first use. Periodic recharging is important to help maximize useful life of the battery. Do not store the internal battery for extended periods, without recharging, as this may reduce the maximum life.

• To connect the ventilator to an external power source, first ensure the ventilator’s I/O switch is off (O). Then, connect the desired power cable to the ventilator. Finally, connect the power cable to the external power source.

• To disconnect the ventilator from an external power source, first power-down the ventilator.

Then, disconnect the power cable from the external power source and, finally, the ventilator.

• Connect the external DC power source by first connecting the power cable to the ventilator and then to the external DC source. Follow the reverse procedure to disconnect the device from the external DC power source.

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Clinician’s Manual

Safety Information

• Connect the external electrical power source by first connecting the power cable to the ventilator and then to the external power source. Follow the reverse procedure to disconnect the device from electrical power sources.

Warnings Regarding Oxygen

• The ventilator must not be used with flammable anesthetic substances.

• Oxygen therapy for patients with respiratory failure is a common and effective medical prescription. However, be aware that inappropriate oxygen use may potentially lead to serious complications, including, but not limited to, patient injury.

• Strictly follow the instructions provided in section 6.8.2, “Connecting the Oxygen Supply” , which

include the use of a flow regulator and special oxygen connector.

• To avoid injury to the patient and/or possible damage to the ventilator: before connecting the ventilator to the oxygen supply, ensure a flow meter (flow regulator) is connected to the ventilator to regulate the oxygen supply to the required specification.

• The Puritan Bennett™ 560 Ventilator can be used with an optional oxygen analyser with minimum and maximum concentration alarms. Always measure the delivered oxygen with a calibrated oxygen analyser (FIO

kit) that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.

• The Puritan Bennett 560 Ventilator is designed to deliver a percentage of oxygen equal or lower than 50%. Do not exceed this value as this may cause the ventilator to malfunction and put the patient at risk.

• Ensure that the oxygen supply pressure to the machine never exceeds 7 psi (50 kPa) or a flow of

15 lpm. Refer to

Table B-8 on page B-3 for volume and sensitivity tolerances.

• In the event of an oxygen leak, shut down the supply of oxygen at its source. In addition, remove and/or keep any incandescent source away from the device, which may be enriched with oxygen. Circulate fresh air into the room to bring the oxygen level down to normal.

• The hose connecting the ventilator to the oxygen source must be designed exclusively for use with medical-grade oxygen. Under no circumstances should the oxygen hose be modified by the user. In addition, the hose must be installed without the use of lubricants.

• Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical-grade oxygen.

• The coupler must not remain connected to the oxygen connector unless it also connected to a leak-proof, external oxygen gas source. When an oxygen supply is not being used with the ventilator, disconnect the oxygen source completely from the ventilator.

• To prevent any interference with the internal sensors of the ventilator, do not install a humidifier upstream of the ventilator.

• To ensure stability, when the Puritan Bennett 560 Ventilator is mounted on a cart, the weight of the oxygen bottle should not exceed 14 kg (30 lbs).

• The oxygen supply hose ages even when it is not in use and should be replaced periodically. The expiration date may be located on the back of the hose end-piece.

• The oxygen supply must be regulated using a flow meter connected to the source gas outlet.

• The oxygen supply must be shut off when ventilation is interrupted. Before disconnecting the oxygen hose, allow the ventilator to continue for a few cycles without oxygen to flush the patient circuit of excess oxygen.

• Before connecting the oxygen supply, ensure that the stud on the oxygen connector is protruding outwards.

• Inspect the oxygen coupler before use to ensure it has its black O-ring attached and in good condition. Do not use an oxygen coupler with a missing, damaged, or worn O-ring.

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1-9

Safety Information

Warnings Regarding Electromagnetic Interference

• The Puritan Bennett™ 560 requires special precautions for electromagnetic compatibility and

should be installed and started according to the recommendations found in Appendix B,

“Specifications” In particular, the use of nearby mobile and portable communications equipment

using radio frequencies, such as mobile telephones or other systems exceeding the levels set in

the IEC 60601-1-2 standard, may affect its operation. Refer to section B.10, “Manufacturer’s

Declaration” .

• The use of any accessory other than those specified, with the exception of the power supplies or cables sold by Covidien, may lead to an increase in electromagnetic emissions or a decrease in the equipment protection against electromagnetic emissions. If the ventilator is used adjacent to such accessories or stacked with such devices, the ventilator’s performance should be monitored to verify normal operation.

1.3 Symbols and Markings

Table 1-1. Ventilator Symbols

Symbols Descriptions

It is essential to read, understand, and follow these instructions before using the Puritan Bennett 560

Ventilator (ISO 7000-0434A).

This symbol appears on the ventilator’s back panel, see Table 1-2 , item 5.

Type BF applied part (IEC 60417-5333).

A regulatory standard classification for protection against electrical shock for the part of the device that contacts the patient.

This symbol appears on the ventilator’s back panel; see Table 1-2 , item 5.

Direct current, DC (IEC 60417-5031).

This symbol appears on the ventilator’s back panel and keyboard; see Figure 1-4 , item 9.

Alternating current, AC (IEC 60417-5032).

This symbol appears on the ventilator’s back panel and keyboard; see Figure 1-4 , item 8, and

Figure 2-2 on page 2-5, item 10.

Internal Battery.

This symbol appears on the ventilator’s keyboard; see Figure 2-3 on page 2-6, item 10.

IP31

Insulation class II equipment (IEC 60417-5172).

A regulatory standard classification for protection against electric shock. Class II equipment relies on double insulation rather than protective earthing.

This symbol appears on the ventilator’s back panel; see Table 1-2 , item 5.

Index of Protection rating for the ventilator’s enclosure, defined in IEC 60529 (BSEN60529:1991).

The first digit, 3, indicates protection against the intrusion of small foreign bodies (including fingers, tools, wires, etc. with a diameter greater than 2.5 mm) into the ventilator. The second digit, 1, indicates protection against water dripping or falling vertically, as well as an environment featuring water vapour condensation and/or light rain.

This rating appears on the ventilator’s back panel; see

Table 1-2 , item 5.

CSA – Canadian Standards Association.

This symbol appears on the ventilator’s back panel; see Table 1-2 , item 5.

CE – Conformity European

Signifies compliance with the medical device directive 2007/47/EC.

This symbol appears on the ventilator’s back panel; see Table 1-2 , item 5.

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Safety Information

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

This symbol appears on the ventilator’s front panel UP/UNFREEZE key; see Figure 2-3 on page 2-6,

item 4.

This key is used to: move the LCD display’s cursor upwards, line-by-line; increase the value of displayed and selected parameter settings; restart (“unfreeze”) waveforms tracing.

This symbol appears on the ventilator’s front panel DOWN/FREEZE key; see Figure 2-3 on page 2-6,

item 6.

This key is used to: move the LCD display’s cursor downwards, line-by-line; decrease the value of displayed and selected parameter settings; stop (“freeze”) waveforms tracing.

This symbol appears on the ventilator’s front panel ENTER key; see Figure 2-3 on page 2-6, item 5.

This key is used to confirm command actions.

This symbol appears on the ventilator’s front panel ALARM CONTROL key; see

Figure 2-3 on page 2-6, item 3.

(See my notes, to the left and below, in red).

This key is used to: cancel the audible portion of alarms for 60 seconds at a time; cancel an alarm.

For more information, refer to section F, “Alarms Tests.”

This symbol appears on the ventilator’s front panel MENU key; see Figure 2-3 on page 2-6, item 7.

This key is used to access the ventilator’s menus via the ventilator’s front panel LCD display.

This symbol (IEC 60417– 5009) appears on the ventilator’s front panel VENTILATION ON/OFF button;

see Figure 2-3 on page 2-6, item 8.

This key is used to Start and Stop ventilation.

To patient port.

This symbol appears on the front right of the ventilator, adjacent to the To Patient port;

see Figure 1-1 on page 1-15, item 1.

From patient-port (double-limb option).

This symbol appears on the front-left of the ventilator, adjacent to the From Patient

port; see Figure 1-1 on page 1-15, item 4.

Patient proximal pressure port.

This symbol appears on the front right of the ventilator, adjacent to the From Patient port;

see Figure 1-1

on page 1-15 and Figure 1-4 on page 1-17, item 3.

Exhalation valve pilot port.

This symbol appears on the front right of the ventilator, adjacent to the To Patient port indicating the connection of the tubing between the patient circuit exhalation valve;

see Figure 1-1 on page 1-15, and

Figure 1-4 on page 1-17, item 3.

Oxygen inlet.

This marking appears on the back panel of the ventilator, adjacent to the oxygen inlet port;

see Figure 1-3 on page 1-16, item 2.

Nurse Call connector.

This symbol appears on the back panel of the ventilator, adjacent to the nurse call connector;

see Figure 1-3 on page 1-16, item 2.

Switch in “Off” position (IEC 60417-5008).

This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator to indicate the switch’s “Off” position. See

Figure 2-2 on page 2-5, item 2.

Switch in “On” position (IEC 60417-5007).

This symbol appears on the I/O (power on/off) switch on the back panel of the ventilator to indicate the switch’s “On” position. See

Figure 2-2 on page 2-5, item 2.

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Clinician’s Manual

Safety Information

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

Software Lock Enabled.

This symbol appears on the upper-left of the ventilator’s LCD display when the keyboard Locking Key is

enabled; see section 7.8, “Locking the Control Panel” .

Internal Battery.

This symbol appears on the top-center of ventilator’s LCD display to indicate that the ventilator is being

on page 2-7, item 1 and refer to chapter 8, “Internal

Battery” , for more information.

Pressure rise times (inspiratory phase) parameter.

These symbols appear on the ventilation mode menu screens. For more information, refer to chapter 3,

“Operating Parameters” . In pressure ventilation modes, you can select one of four rise times with

setting 1 representing the fastest rise time and setting 4 representing the slowest.

Flow shape (“flow distribution shape”, inspiratory phase) parameter.

These symbols appear on the ventilation mode menu screens; selectable for V A/C mode only. For

more information, refer to chapter 3, “Operating Parameters”

. In volume ventilation mode you can select between Square (SQ), Descending (D) or Sinusoidal (S) flow patterns.

Selected line (filled square).

When making menu choices, this graphic indicates the line on which the cursor is currently positioned.

See Figure 7-11, Selecting the Preferences Menu , on page 7-10.

Non-selected line (empty square).

When making menu choices, this graphic indicates a line on which the cursor is currently not positioned.

Locked parameter line.

When making menu choices, this graphic indicates a line that cannot be selected (the Locking Key is enabled).

Active parameter line.

When making menu choices, this graphic indicates that the current parameter is selected and can be

changed. See chapter 7, “Operating Procedures” .

Inspiratory Effort Detected.

This symbol appears in the front panel display’s Status window when the patient triggers a breath.

Parameter adjustment bar.

This graphic shows the current setting for parameters such as display contrast and alarm volume in the

Preferences menu. Refer to section 7.3, “Preferences Menu Parameters”

WEEE (Waste Electrical and Electronic Equipment).

This symbol means that this product must not be disposed of with household waste. Observe local ordinances for proper disposal. Refer to

Table 1-2

, item 5.

Year of Manufacture.

Manufacturer.

Audio Paused.

This symbol means the sounding of audible alarms is currently disabled. For more information, refer to

section 5.4, “Silencing the Audible Portion of Alarms” .

Alarm Paused (reset/cancelled).

This symbol means one or more alarms have been paused, or reset/cancelled. For more information,

refer to section 5.5, “Pausing/Resetting Alarms” .

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Safety Information

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

Apnea Alarm Deactivated.

This symbol means that the Apnea Alarm has been deactivated. For more information, refer to section

5.5, “Pausing/Resetting Alarms” .

Exhalation Valve detected.

This symbol means that an exhalation valve has been detected during ventilation.

No Exhalation Valve detected.

This symbol means that no exhalation valve has been detected during ventilation.

Single patient use only (ISO 7000-1051).

This symbol means that the labeled device is for use by a single patient only.

Freeze Waveforms.

This symbol means the tracing of patient pressure and flow waveforms is currently paused or “frozen.”

For more information, refer to section 4.3, “Waveform Display” .

Follow instructions for use (ISO 7000-1641).

This symbol directs the user to observe and adhere to the instructions contained in the product’s user manuals.

USB port.

This symbol indicates a communications port for interfacing with a USB connector.

See

Figure 2-2 , item 11.

PC connector.

This symbol indicates a port that can be used by authorised Covidien product service personnel or

Covidien service personnel for software maintenance. See

Figure 2-2

, item 10.

Atmospheric pressure limitation.

Humidity limitations.

Temperature limitations.

Fragile.

Keep dry.

Keep away from direct sunlight.

This side up.

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Safety Information

1.4 Labels / Identification and Instruction Information

Various labels or specific markings are affixed to the ventilator that describe precautions to be taken for the correct use of the ventilator and contribute to the traceability of the product. Refer to

Table 1-2

and the figures on the following pages for illustrations of these labels and markings and their locations on the ventilator. Use the item numbers in the following tables to locate the labels in

Figure 1-1

to Figure 1-4 .

Table 1-2. Ventilator Labels and Markings

1. Patient Gas Inlet Label

(

Figure 1-1 ,

2. Oxygen Inlet Marking and Label

( Figure 1-3

)

3. Exhalation Valve and Patient

Pressure Connection Label

(

Figure 1-1 ,

1-14

4. From Patient Port,

Exhalation Limb Connection of

Patient Circuit – Single Use

Exhalation Block Label

(

5. Air Inlet Label

)

Location of AC

Power Cable

Connector

6. Exhaled Gas Outlet Label

(

Figure 1-2 )

Location of DC

Power Cable

Connector

7. Identification Label

(

8. AC Power (Mains)

Cable Connector Marking

( Figure 1-3

)

9. External Cable

Connector Marking

(

Figure 1-3 )

10. PC Connection marking

(

Figure 1-3 )

11. USB Port marking

( Figure 1-3

)

12. Nurse Call Cable

Connector Marking

(

Figure 1-3 )

Clinician’s Manual

Table 1-2. Ventilator Labels and Markings (Continued)

13. FIO

Label

(

Figure 1-1 ,

The item number callouts in the following figures refer to those listed in Table 1-2 .

Note:

Safety Information

4 3

Figure 1-1. Locations of Labels – Top-Front View

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Safety Information

1-16

Figure 1-2. Locations of Labels – Front-Left View

12 2 2

Figure 1-3. Location of Labels and Markings – Rear View

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Figure 1-4. Location of Labels – Bottom View

Safety Information

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2 Ventilator Overview

2.1 Indications for Use

The Puritan Bennett™ 560 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 lb (5 kg) who require mechanical ventilation.

The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a doctor. It is essential to read, understand, and follow these instructions before using the Puritan Bennett 560 Ventilator.

Target Patients

Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:

• Positive Pressure ventilation

• Assist/Control, SIMV, or CPAP modes of ventilation

• Breath types including Volume Control, Pressure Control, and Pressure Support

Target Environments

The ventilator is suitable for use in institutional, home, and portable settings. It is not intended for use as an emergency transport ventilator.

The Puritan Bennett 560 Ventilator is suitable for use on commercial aircraft, per FAA requirements.

Refer to chapter B.11, “Standards Compliance and IEC Classification” . Patients traveling with the

Puritan Bennett 560 Ventilator may be required by their airline to demonstrate evidence of compliance with the RTCA/DO-160F standard, as well as other requirements. Contact your airline prior to travel to determine airline specific requirements and documentation.

Warning

Even though the Puritan Bennett 560 Ventilator meets current safety standards, the internal

Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the

Puritan Bennett 560 Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA:

International Air Transport Association), International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by

Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements apply. For air transport; the

Puritan Bennett 560 Ventilator is permitted as checked-in or carry-on baggage. Two spare batteries per person may be taken on board as carry-on luggage only, with the prior approval of the airline. This classification and regulatory requirements may vary depending upon the country and mode of transport. Therefore it is recommended that users verify with the carrier / airline as to which measures to take before the voyage.

Ventilator Overview

Target Operators

The ventilator may be operated by:

• Respiratory therapists

• Doctors

• Nurses

• Homecare providers

• Patient and patient’s families

For more details on the knowledge and skill requirements for operating the Puritan Bennett™ 560

Ventilator, refer to Appendix A Patient/Caregiver Checklist.

Warning

This ventilator must be used only under the responsibility and on the prescription of a doctor.

2.2 Contraindications

This ventilator is not for use with anesthetic gases, and is not intended for use as an emergency transport ventilator.

2.3 Operational Use

The Puritan Bennett 560 Portable Ventilator uses a micro-turbine to provide ventilatory support to patients. Clinicians may use a variety of interfaces to connect patients to the ventilator: nasal masks or full face masks; endotracheal or tracheotomy tubes. User-selectable ventilation modes are:

• Assisted Controlled Volume (V A/C)

• Assisted Controlled Pressure (P A/C)

• Volume Synchronised Intermittent Mandatory Ventilation (V SIMV)

• Pressure Synchronised Intermittent Mandatory Ventilation (P SIMV)

• Continuous Positive Airway Pressure (CPAP)

• Pressure Support Ventilation with apnea ventilation (PSV/ST)

Safety Net

Incorporated in the ventilator design is an alarm system that continuously monitors both patient and machine for signs of specific errors or faults that could lead to an unsafe condition. Should any of these errors or faults be detected, the alarm system announces the specific alarm condition both audibly and visually. The machine-related alarm conditions are factory set, whereas the patientrelated alarm conditions are defined by alarm-threshold values selected by an operator (a clinician

or a caregiver). For more information, refer to chapter 5, “Alarms and Troubleshooting.”

Settings

A software key, known as the “Locking Key,” restricts access to ventilation parameter settings and ventilation mode changes in order to distinguish between “clinician” usage and “patient” usage

(refer to section 7.8, “Locking the Control Panel,” on page 7-28

Oxygen Enrichment

Oxygen may be supplied from an external, low pressure source, but the oxygen flow must be limited to 15 lpm (50 kPa, 7 PSI). The ventilator automatically compensates for the extra flow created by the external oxygen supply

(

refer to chapter 6, “Installation and Assembly.”

)

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Ventilator Overview

Breathing Circuit

The ventilator can be used with a single or double limb patient circuit. If exhaled volume monitoring is required (such as ventilator dependant patients), use the double-limb circuit for

exhaled tidal volume monitoring. For more information, refer to section 6.4, “Patient Circuit,” on page 6-6

Warning

Users must always possess an additional breathing circuit and exhalation valve while using the

Puritan Bennett™ 560 Ventilator.

2.4 Device Classification

The ventilator’s IEC / EN 60601-1classification is as follows:

• Protection/Insulation class (electric shock): Class II

• Protection index of enclosure: IP31

• Medical device directive classification: II B

• Degree of protection against risk of electric shock: BF

• Power: External (AC – mains, or DC – cigarette lighter) or internal (DC – battery)

• Operation mode: Continuous operation

For additional information, refer to section B, “Specifications.”

Clinician’s Manual

2-3

Ventilator Overview

2.5 Front Panel

8 7 6 5

LCD Display – Displays information about the ventilator including patient hours and software version, ventilation modes and settings, and monitored and calculated patient data and waveforms. The display also allows the user to view and, using the Control

Panel, adjust the ventilator’s operating and alarm configuration settings.

Control Panel – Features the controls for setting up and operating the ventilator, and LEDs to indicate the ventilator's power source, ventilation On/Off status, and alarm priority level. Control functions include turning on and off the ventilation, configuring ventilation modes, silencing and cancelling alarms, and setting device and alarm parameters.

Exhalation Valve Port – Nipple for providing piloting pressure to the exhalation valve. Controls the open-closed position of the exhalation valve.

Lateral and Front Openings – Vents that allow for air circulation to cool the ventilator’s internal components. In addition, these openings function as sound ports for audible alarms.

Warning

Do not cover or obstruct these openings.

3 FIO

Sensor Connection – Connection for FIO

sensor which monitors the amount of oxygen in the patient circuit.

From Patient Port – Exhaled volume measurements are taken from this port, through which a portion of the exhaled gas is diverted to the exhalation flow sensor. VTE is calculated from this flow measurement.

Exhaled Gas Outlet – Exhalation Valve connects here.

Patient Connection Port – Provides an outlet for the gas to be delivered to the patient via the patient circuit.

Patient Pressure Monitoring Port – Nipple for monitoring proximal patient pressure.

a. If exhaled tidal volume monitoring is required, use the double-limb circuit.

Figure 2-1. Front Panel

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Clinician’s Manual

2.6 Back Panel

Ventilator Overview

9 8

7 6 5

Ergonomic carrying handle.

On/Off (I/O) switch with protective cover:

Device powered on in position I; device switched off in position 0.

AC power (“Mains”) cable connector.

AC power (“Mains”) cable holding system:

Secures AC power cable to avoid accidental disconnection.

Access cover for the internal battery.

DC power cable connector with key.

PC Cable Connector:

USB mini-B connector used for Puritan Bennett™

Ventilator Test Software.

Inlet Port:

Connects the ventilator to a low pressure oxygen source via an adaptor connected to the O

Inlet

(refer to section 6.8, “Oxygen,” on page 6-14

Nurse Call Output Connector:

Used to connect the ventilator to the nurse call system.

USB Memory Device connection:

USB connection to be used with Puritan Bennett respiratory insight software. There are two USB type A ports.

Air Inlet Filter:

Filters air as it enters the ventilator.

Figure 2-2. Back Panel

Clinician’s Manual

2-5

Ventilator Overview

2.7 Control Panel

Alarm indicators (two LEDs):

Red indicator:

• Continuous: Very High Priority (VHP) alarm activated

• High priority (HP) alarm activated.

Yellow indicator:

• Medium priority (MP) alarm activated.

DOWN/FREEZE key:

• Moves the cursor down and decreases parameter values.

• During ventilation, freezes displayed waveform in the

Waveform menu.

ALARM CONTROL key:

• Press once to silence an audible alarm for

60 seconds.

• Press twice to halt visual and audible alarms. If alarm is remedied, the alarm is cancelled (other than the high pressure alarm).

Display screen:

Display of modes, ventilation settings, patient data and waveforms, configuration of the ventilator and alarm management.

UP/UNFREEZE Key:

• Moves the cursor up and increases parameter values.

• During ventilation reactivates waveform tracing in the Waveform menu.

ENTER key:

• Access to a setting value and validation of the modification of this setting.

• Access to a sub-menu.

MENU key:

Changes the displayed menu. From the Ventilation menu screen, press this key to display the Alarm menu screen.

When a USB memory device is inserted into the ventilator, press this key to display the USB memory device screen.

VENTILATION ON/OFF button:

• ON: Press briefly and release to start ventilation.

• OFF: Press and hold for three (3) seconds, then press again to stop ventilation.

Ventilation status indicator:

• Blue indicator illuminated: device is powered on and ventilation is off (on standby).

• Blue indicator off: ventilation is on.

10 Electrical power source indicators:

• AC POWER indicator lit: AC power source connected.

• DC POWER indicator lit: DC power source connected.

• INTERNAL BATTERY indicator lit continuously: Internal battery in use (no external power source connected.)

• INTERNAL BATTERY indicator flashing: battery charging.

Figure 2-3. Control Panel

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Clinician’s Manual

Ventilator Overview

2.8 Ventilation Menu

Ventilation menu with ventilation on standby.

PB560C01

Ventilation menu during ventilation.

PB560C02

General information line:

Displays the current ventilation mode, along with the following:

• Battery symbol if the device is powered by the internal battery.

• Audio paused symbol if an alarm is currently inhibited.

• Alarm paused symbol if an alarm has been cancelled manually and the cause of the alarm remains.

• Apnea Alarm deactivation

• Exhalation valve symbol.

• No exhalation valve symbol.

• Absolute ABS symbol.

• Relative REL symbol.

Bargraph:

Displays pressure generation during ventilation.

Ventilation settings:

Displays the specific ventilation parameter values for the currently selected ventilation mode.

Refer to chapter 3, “Operating

Parameters” for more

information.

Preferences menu access line:

Highlight this line and press the ENTER key to display the Preferences menu.

Refer to manual section 7.3,

“Preferences Menu

Parameters,” on page 7-10

for more information.

Status/monitored data window:

• Ventilation stopped

(Standby): displays the message, “PRESS TO

START VENTILATION.”

• Ventilation on: parameters are monitored and displayed.

• The Inspiratory Effort

Detected symbol appears adjacent to the monitored I:E ratio when the patient actively triggers a breath.

Alarm conditions window:

• For Active alarms, scrolls through active alarm messages in flashing reverse video.

• For Inactive alarms, displays the last alarm along with its trigger date and end-of-event time.

Refer to chapter 5, “Alarms and Troubleshooting”

for details.

Figure 2-4. Ventilation Menu Display

Clinician’s Manual

2-7

Ventilator Overview

2.9 Alarm Menu

PB560C03

Alarm menu with ventilation on standby.

PB560C04

Alarm menu when not in standby.

Title line:

Displays ventilation mode and the following symbols:

• Battery if the ventilator is powered by the internal battery

• Audio paused if an alarm is currently inhibited.

• Alarm paused if an alarm has been cancelled manually and the cause of the alarm remains.

• Apnea Alarm deactivation

• Exhalation valve symbol.

• No exhalation valve symbol.

Alarm settings:

Displays the specific alarm parameter values for the currently selected ventilation mode, which are:

• Min and Max alarm threshold settings, and

• Current monitored patient readings, or hyphen (-) when ventilation is in standby.

Access line to Alarm Logs menu.

Highlight this line and press the

ENTER key to display the Alarm Logs menu.

Refer to manual section

5.3, “Alarm Logs Menu,” on page 5-3 .

Status/monitored data window:

• Ventilation stopped (Standby): displays the message, “PRESS

TO START VENTILATION.”

• Ventilation on: parameters are monitored and displayed.

• The Inspiratory Effort Detected symbol appears adjacent to the monitored I:E ratio when the patient actively triggers a breath.

Alarm message window:

• For Active alarms, scrolls through active alarm messages in flashing reverse video.

• For Inactive alarms, displays the last alarm along with its trigger date and end-of-event time.

Refer to chapter 5, “Alarms and

Troubleshooting” for more

information.

Figure 2-5. Alarm Menu

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Clinician’s Manual

Ventilator Overview

2.10 Waveforms Menu

The display of waveforms (

Figure 2-6

) is optional and can be selected using the Menu key

(refer to chapter 4, “Monitored Parameters.” ). The Waveform menu is only accessible when

ventilation is active.

PB560C05

Title line:

• Displays ventilation mode and the following symbols:

• Battery if the ventilator is powered by the internal battery

• Audio paused if an alarm is currently inhibited.

• Alarm paused if an alarm has been cancelled manually and the cause of the alarm remains.

• Apnea Alarm deactivation.

• Freeze Waveforms if the tracing of patient waveforms has been halted during ventilation.

• Exhalation valve symbol.

• No exhalation valve symbol.

Graphic zone:

Displays the patient’s pressure and flow waveforms as a function of time.

For more information, refer to chapter 4, “Monitored

Parameters.”

Numeric zone:

Displays monitored data.

Figure 2-6. Waveforms Menu

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2-9

Ventilator Overview

2.11 USB Memory Device Menu

PB560C70

Title line

Ventilator serial number

Figure 2-7. USB Memory Device Menu

USB Memory Device Menu

Dialogue box

2.12 If Ventilator Failure Occurs

If a problem with the ventilator is suspected, FIRST CHECK THAT THE PATIENT IS NOT IN DANGER.

If necessary, remove the patient from the ventilator and provide an alternate means of ventilation.

Keep in mind that troubleshooting information is available in this manual to assist you in the event

of a problem. Refer to chapter 5, “Alarms and Troubleshooting”

If you cannot determine the cause of a problem, contact your equipment supplier or Covidien.

Refer to chapter 10.5, “Service Assistance” .

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Clinician’s Manual

3 Operating Parameters

This chapter describes ventilation and alarm parameters and their setting ranges for each ventilation mode. For a listing of operating parameters and monitored patient data, refer to

Table B-11 on page B-8. For further information about the different ventilation modes and breath

types provided by the Puritan Bennett™ 560 Ventilator, refer to Appendix D, “Modes and Breath

Types.”

Warning

If APNEA TIME is set to a value higher than 60/Rate then the APNEA alarm will not activate.

3.1 PSV Mode Parameters and Setting Ranges

The menus for PSV – Pressure Support Ventilation mode are shown in

Figure 3-1

, and

Figure 3-2 :

PB560C08 PB560C09

PB560C08A

Figure 3-1. Menus in PSV Mode with exhalation valve configuration

PB560C09A

Figure 3-2. Menus in PSV Mode with leakage configuration

The ventilation parameters and setting ranges available in PSV mode are listed in

Table 3-1

Operating Parameters

Table 3-1. Ventilation Parameters in PSV Menu

Name Units Min. Value Max. Value

P Support

PEEP

Rise Time

I Sens

E Sens a

Backup R

Apnea Time

Vt Target

Min I Time

Max P

Max I Time cmH

2 hPa cmH

2 hPa

–

% bpm s ml s s

O, mbar or

O, m bar or mbar

Standby: 2

Valve configuration: 5

Leak configuration: 6

Standby: OFF

Valve configuration: OFF

Leak configuration: 4

5 (-95)

0.1

0.8

Standby: 55

Valve configuration: 55

Leak configuration: 30

95 (-5)

2000

2.8

a. Refer to chapter 7, “Operating Procedures”

for information on positive and negative E Sens settings

Adjustment

Resolution

0.1

Default

Value

OFF

Auto

OFF = 100

Auto

PIP + 3

Auto

Linked

Parameters

PEEP

P Support

Max P

Insp Time

–

Min I Time

Backup R

–

Max I Time

–

Min I Time

Table 3-2

lists the available alarm settings in PSV mode.

Table 3-2. Alarm Parameters in PSV Mode

Name

Min VTI

Max VTI

Min VTE (with exhalation valve)

Max VTE (with exhalation valve)

Max Leak

(with leak configuration)

Max Rtot

Min FIO

Max FIO

Units

ml ml ml ml lpm bpm

Min.

Value

Max.

Value

2000

3000

1990

3000

200

100

Adjustment

Resolution

Default

Value

300

2,000

300

1000

OFF

Linked

Parameters

Max VTI

Min VTI

Max VTE

Min VTE

–

OFF

Backup R

Max FIO

Min FIO

P Support – Pressure Support

When Relative Pressure is set to YES in the Setup Menu, P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase.

In this configuration, the sum of P Support and PEEP must not exceed 55 mbar.

When Relative Pressure is set to OFF in the Setup Menu, P Support allows you to determine inspiratory Absolute pressure.

In this configuration, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

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Clinician’s Manual

Operating Parameters

PEEP – Positive End Expiratory Pressure

PEEP allows you to determine the level of pressure maintained during the exhalation phase.

When Relative Pressure is set to YES in the Setup Menu, the sum of P Support and PEEP must not exceed 55 mbar.

When relative pressure is set to OFF, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.

In leak configuration, the minimum PEEP setting is 4 mbar.

Rise Time

This parameter is used during the inspiration phase to determine how the target pressure will be reached. This setting indirectly defines the minimum inspiratory time.

The different levels available are as follows:

Rise time = 200 ms

Rise time

= 400 ms

= 600 ms

Rise time = 800 ms

These time ranges are determined by the pressure setting required, the breath rate , and the physiological condition of the patient.

I Sens – Inspiratory Trigger Sensitivity

I Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath.

The sensitivity levels decrease from 1P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.

I Sens 1 (P) = Bias flow + (0.4 lpm to 1 lpm) (P = Pediatric use)

I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)

I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)

I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)

I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)

The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO

The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms, depending on the preceding peak inspiratory flow.

Warning

Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths.

Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering.

Level 1P, the most sensitive inspiratory trigger, is recommended for pediatric use. For an adult, this setting may result in ventilator autotriggering.

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3-3

Operating Parameters

E Sens – EXHALATION SENSITIVITY

E sens is available in the PSIMV, VSIMV, and PSV modes.

E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.

The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting.

The exhalation trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.

If the flow drop is insufficient, exhalation is automatically triggered independently of the E Sens, which is defined as a percentage of peak inspiratory flow. Exhalation may be triggered if the maximum inspiratory time of three (3) seconds has elapsed, which corresponds to an I:E Ratio of

1:1.0, to ensure that the patient has enough time to exhale.

3-4

Figure 3-3.

Exhalation Trigger Sensitivity

Note:

(Refer to chapter 7.2.2, “Changing the Setup Menu Parameters”

for positive and negative E Sens settings.)

Backup R

Backup R allows you to determine the frequency of ventilation breaths to be applied in the event of prolonged apnea – as long as no inspiratory trigger is detected.

The inspiratory time of the backup breaths applied in the event of apnea still depends on the detection of Exhalation trigger (E Sens) and the safety maximum inspiratory time (see above comment on E Sens). The rise time of these cycles is identical to the ventilation cycle previously set.

The controlled cycles following apnea are interrupted as soon as a new spontaneous inspiration of the patient is detected.

The Backup R is linked to the Min I Time so that the Min I Time setting cannot be greater than half the inspiratory phase of a ventilator controlled breath.

Backup R breath is delivered at the Pressure Support settings.

Setting a Backup Rate is not optional; it is always set.

Apnea Time

Apnea time allows the user to monitor and detect interruptions to the patient's spontaneous breathing pattern. The ventilator declares apnea when no breath has been delivered by the time that the operator-selected apnea interval elapses.

Clinician’s Manual

Operating Parameters

The APNEA TIME adjustment range shall be 1 to 60 seconds. The ventilator shall enable the operator to set an auto-setting which shall automatically calculate the APNEA TIME according to the following: APNEA TIME = 60 / BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV modes.

The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (Auto = Maximum value between 3 seconds and 60/Backup R or AUTO=30 in CPAP mode).

Note:

During apnea ventilation, the ventilator delivers machine controlled breaths according to a backup rate

(Backup R) – as long as no inspiratory trigger has been detected.

The Backup R value applied depends on the Rate setting.

If the Apnea Alarm is set to OFF in the Preferences Menu, the Apnea Time setting will still be active.

VT Target – TARGET TIDAL VOLUME

VT Target allows the ventilator to deliver a target volume of gas to the patient.

When a VT Target is set, the ventilator constantly adjusts the target inspiratory pressure between

PIP and Max P to ensure the inspired tidal volume remains as close as possible to the VT target.

VT Target should be more than 10 ml higher than Min VTE and more than 10 ml lower than Max

VTI to avoid triggering VTI or VTE alarms.

The minimum increase or decrease of target inspiratory pressure is 0.5 mbar and the maximum is

2 mbar.

Setting the Vt Target is not mandatory (it can be set to “OFF”).

Max P – MAXIMUM INSPIRATION PRESSURE

Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the Target Tidal Volume. (Vt Target)

P Support and Max P are related and the difference between them must be less than 20 mbar.

Max P is not displayed when VT Target is set to OFF.

Min and Max I Time – MINIMUM / MAXIMUM INSPIRATION TIME

Min I Time and Max I Time are ventilation parameters that can be adjusted in the alarm menu.

Min I Time defines the minimum duration of time the inspiratory phase is maintained. It takes priority over activation of the exhalation trigger which can only be triggered after the Min I Time has expired.

The Backup R is linked to the Min I Time so that the Min I Time setting cannot be greater than half the inspiratory phase of a cycle triggered by the ventilator.

If Backup R is changed, Min I Time is, if necessary, automatically readjusted so that the difference between them is always maintained.

The minimum time by default if no parameter is set (Min I Time = AUTO) corresponds to the lower

value in the range of the Rise Time to which an operating margin of 0.3 seconds is added. See

“Rise Time” on page 3-3 for details about Rise Time.

Max I Time defines the maximum duration of time during which the inspiratory phase is maintained. The switch-over to exhalation occurs , at the latest , after this time has expired.

By default, if no parameter is set, the maximum time (Max I Time = AUTO) is the shortest time between a fixed time of three (3) seconds and half the duration of the patient’s inspiratory breaths expressed in seconds. (AUTO equals the lesser of 3 seconds or 30/Rate). This default value will be applied if it is lower than the Max I Time setting.

Min I Time and Max I Time are related so that the Max I Time cannot be set to a value lower than the Min I Time.

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3-5

Operating Parameters

VTI (Min and/or Max Alarm Settings) – INSPIRATORY TIDAL VOLUME

It is possible to set a minimum and/or maximum Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.

This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI” alarm) or greater than the maximum threshold set (“HIGH VTI”

alarm). Refer to chapter 5, “Alarms and Troubleshooting”

Min VTI and Max VTI are related, and their settings must be set to values that maintain a minimum difference of 20 ml between the two.

It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.

VTE (Min and/or Max Alarm Settings) – EXHALATION TIDAL VOLUME

Use a double limb patient circuit configuration when setting the minimum and/or maximum

Exhalation Tidal Volume alarm parameters.

These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE” alarm) or greater than the maximum threshold set

(“HIGH VTE” alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.

VTE is displayed when ventilating with an exhalation valve.

It is not mandatory to set the minimum and maximum VTE alarm limits. When the minimum and maximum VTE alarm limits are not set, the display will read “OFF” for these settings.

Max Leak (Max Alarm Settings)

The setting of a high leakage threshold enables a “HIGH LEAKAGE” alarm to be triggered in the event the calculated leakage flow exceeds this limit. The displayed value corresponds to the mean parasite leakage flow observed during the exhalation phase.

Max Leak is displayed when ventilating without an exhalation valve.

Setting the Max Leak is not mandatory (it can be set to “OFF”) , but the measured value is always displayed.

Max Rtot (Max Alarm Setting) – TOTAL BREATH RATE

The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering.

The alarm setting is used to trigger the “HIGH RATE” alarm. Refer to chapter 5, “Alarms and

The ventilation parameters and setting ranges available in CPAP mode are listed in Table 3-3 .

When set, the Max Rtot threshold must always exceed the Backup Rate by 5 bpm. If the Backup

Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of

5 bpm.

Setting the Max Rtot is not mandatory (it can be set to “OFF”) , but the measured value is always displayed.

FIO

– (Min and/or Max Alarm Settings) – FRACTION OF INSPIRED OXYGEN

An FIO

sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.

Min and Max FIO

thresholds can be set to trigger “LOW FIO

” or “HIGH FIO

” alarms.

Min FIO

and Max FIO

thresholds are related and their settings must maintain a minimum difference of 10% between the two.

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Clinician’s Manual

Operating Parameters

Min and Max FIO

settings can be set to OFF if an FIO

2 sensor is not connected. Settings are automatically restored once a sensor is reconnected.

These settings are the same for all ventilation modes.

3.2 CPAP Mode Parameters and Setting Ranges

The menus in CPAP (Continuous Positive Airway Pressure) ventilation mode are shown below:

PB560C06

PB560C07

Figure 3-4. Menus in CPAP Mode in leakage configuration

Table 3-3. Ventilation Parameters in CPAP Menu

Name Units

Min.

Value

4 PEEP

Apnea Time a cmH

O, mbar or hPa s 1 a. not available if Apnea Alarm is set to OFF in Preferences Menu

Max.

Value

Adjustment

Resolution

Default

Value

Auto

Linked

Parameters

PIP

Backup R

Table 3-4

lists the available alarm settings in CPAP mode.

Table 3-4. Alarm Parameters in CPAP Mode

Name

Min VTI

Max VTI

Max Leak

Max Rtot

Min FIO

Max FIO

Units

ml ml lpm bpm

Min.

Value

Max.

Value

2,000

3,000

200

100

Adjustment

Resolution

Default

Value

300

2,000

OFF

Linked

Parameters

Max VTI

Min VTI

–

Backup R

Max FIO

Min FIO

Warning

The CPAP mode does not feature control cycles. Do not use this mode for ventilator-dependent patients.

Note:

Only leak configuration

is available in CPAP mode.

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3-7

Operating Parameters

PEEP – Positive End Expiratory Pressure

PEEP allows you to determine the level of pressure maintained during the exhalation phase.

The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”).

A PEEP value can be set to determine the level of pressure maintained during the inspiratory phase and the exhalation phase.

Apnea Time

The Apnea Time “AUTO” setting is 30 seconds.

Apnea Time is not available if Apnea Alarm is set to OFF in the Preferences Menu.

VTI (Min and/or Max Alarm Settings) – INSPIRATORY TIDAL VOLUME

It is possible to set a Min and/or Max Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.

alarm). Refer to chapter 5, “Alarms and Troubleshooting”

Min VTI and Max VTI are related, and their settings must be set to values that maintain a minimum difference of 20 ml between the two.

It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.

Max Leak (Max Alarm Settings)

It is not mandatory to set the minimum and maximum LEAK alarm limits. When the minimum and maximum LEAK alarm limits are not set, the display will read “OFF” for these settings.

Max Rtot (Max Alarm Setting) – TOTAL BREATH RATE

The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering.

The alarm setting is used to trigger the “HIGH RATE” alarm. Refer to chapter 5, “Alarms and

The Ventilation parameters adjustable in P A/C mode are listed in Table 3-5 .

When set, the Max Rtot threshold must always exceed the Backup Rate by 5 bpm. If the Backup

Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of

5 bpm.

Setting the Max Rtot is not mandatory (it can be set to “OFF”) , but the measured value is always displayed.

I Sens – INSPIRATORY TRIGGER SENSITIVITY

The trigger threshold for switching to inhalation cannot be set in CPAP mode. The device is configured with a default I Sens of 2.

E Sens – EXHALATION TRIGGER SENSITIVITY

The trigger threshold for switching to exhalation cannot be set in CPAP mode. The device is configured with a default E Sens of 25%.

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Clinician’s Manual

Operating Parameters

FIO

(Min and/or Max Alarm Settings) – Fraction of Inspired Oxygen

An FIO

sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.

Min and Max FIO

thresholds can be set to trigger “LOW FIO

” or “HIGH FIO

” alarms.

Min FIO

and Max FIO

thresholds are related and their settings must maintain a minimum difference of 10% between the two.

Min and Max FIO

settings can be set to OFF if an FIO

2 sensor is not connected. Settings are automatically restored once a sensor is reconnected.

These settings are the same for all ventilation modes.

3.3 P A/C Mode Parameters and Setting Ranges

The menus in P A/C (Pressure Assisted/Controlled) ventilation mode are shown in

Figure 3-5

PB560C10

PB560C11

Figure 3-5. Menus in P A/C Mode with exhalation valve configuration

PB560C10A PB560C11A

Figure 3-6. Menus in P A/C Mode with leakage configuration

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3-9

Operating Parameters

Table 3-5. Ventilation Parameters in P A/C Mode Menu

Name

PIP

PEEP

Rise Time

Rate

I:E/

(I/T)

I Sens

VT Target

Max P

Units

cmH

O, mbar or hPa cmH

O, mbar or hPa

–

Min. Value Max. Value

Standby: 2

Valve configuration: 5

Leak configuration: 6

Standby: 55

Valve configuration: 55

Leak configuration: 30

20 Standby: OFF

Valve configuration: OFF

Leak configuration: 4

Adjustment

Resolution

1 4 1

Default

Value

OFF

Linked

Parameters

PEEP

PIP bpm s

5 60 1 13

Rate

I/T

Max Rtot

–

– ml

1/4

(20%)

OFF

1/1

(50%)

2000

1/0.1

(1%)

1/2

(33%)

OFF cmH

2 hPa

O, mbar or

8 55 1 PIP + 3

–

Min VTE

Max VTE

Min VTI

Max VTI

PIP

PEEP

Table 3-6

lists the adjustable alarm parameters in P A/C mode.

Table 3-6. Alarm Parameters in P A/C Mode

Name

Min VTI

Max VTI

Min VTE

(with exhalation valve)

Max VTE

(with exhalation valve)

Max Leak

(leakage configuration)

Max Rtot

Min FIO

Max FIO

Units

ml ml ml ml ml bpm

Min.

Value

Max.

Value

2,000

3,000

1,990

Adjustment

Resolution

3,000

200

100

Default

Value

300

2000

300

Linked

Parameters

Max VTI

Min VTI

Max VTE

1000

OFF

Min VTE

–

Rate

Max FIO

Min FIO

3-10

Clinician’s Manual

Operating Parameters

PIP – Peak Inspiratory Pressure

When Relative Pressure is set to YES in the Setup Menu, PIP allows you to determine inspiratory pressure added to PEEP during the inspiratory phase.

In this configuration, the sum of PIP and PEEP must not exceed 55 mbar.

When Relative Pressure is set to OFF in the Setup Menu, PIP allows you to determine inspiratory

Absolute pressure.

In this configuration, PIP and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

PEEP – Positive End Expiratory Pressure

PEEP allows you to determine the level of pressure maintained during the exhalation phase.

When Relative Pressure is set to YES in the Setup Menu, the sum of PIP and PEEP must not exceed

55 mbar.

When relative pressure is set to OFF, PIP and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.

In leak configuration, the minimum PEEP setting is 4 mbar.

Rise Time

This parameter is used during the inspiration phase to adjust how the pressure setpoint will be reached. This setting indirectly defines the minimum inspiratory time.

The different levels available are as follows:

Rise time = 200 ms

Rise time

= 400 ms

= 600 ms

Rise time = 800 ms

These time ranges are determined by the combination of the pressure setting required, the breath rate and the physiological conditions of the patient.

The pressure rise time built-up at each cycle depends on the inspiratory time corresponding to the combination of the rate setting and the Insp Time setting.

• Rise Time is always possible

• Rise Time is established only if Insp Time



0.7 seconds

• Rise Time is established only if Insp Time



0.9 seconds

• Rise Time is established only if Insp Time



1.1 seconds.

Note:

Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.

Rate – RESPIRATORY RATE

Rate allows you to define the minimal frequency of mandatory ventilator breaths.

If the patient actuates the inspiration trigger, Total Rate may increase.

Note:

Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.

Clinician’s Manual

3-11

Operating Parameters

I:E (I/T) Cycling rate

I:E allows you to determine the ratio between the inspiratory breath phase duration and the exhalation breath phase duration.

I/T allows you to determine the ratio between the inspiratory breath phase duration and the total breath duration (inhalation + exhalation).

Note:

Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.

I Sens – INSPIRATORY TRIGGER SENSITIVITY

I Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.

The sensitivity levels decrease from 1P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.

I Sens 1 (P) = Bias flow + (0.4 lpm to 1 lpm) (P = Pediatric use)

I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)

I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)

I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)

I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)

The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO

The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow. I Sens can be set to OFF.

Warning

The inspiration trigger threshold should be carefully modified in order to avoid the risk of false triggering or “autotriggering” of the ventilator. For example, Level 1P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.

VT Target – TARGET TIDAL VOLUME

VT Target allows the ventilator to deliver a target volume of air to the patient.

When a VT Target is set, the ventilator constantly adjusts the target inspiratory pressure between

PIP and Max P to ensure the inspired tidal volume remains as close as possible to the VT target.

VT Target should be more than 10 ml higher than Min VTE and more than 10 ml lower than

Max VTI to avoid triggering VTI or VTE alarms.

The minimum increase or decrease of target inspiratory pressure is 0.5 mbar and the maximum is

2 mbar.

Setting the Vt Target is not mandatory (it can be set to “OFF”).

Max P – MAXIMUM INSPIRATION PRESSURE

Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the Target Tidal Volume. (Vt Target)

PIP and Max P are related and the difference between them must be less than 20 mbar.

Max P is not displayed when VT Target is set to OFF.

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Clinician’s Manual

Operating Parameters

VTI (Min and/or Max Alarm Settings) – INSPIRATORY TIDAL VOLUME

It is possible to set a Min and/or Max Tidal Volume alarm threshold for the patient’s inspired tidal volume during a cycle.

This setting is used to trigger an alarm if the tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI” alarm) , or greater than the maximum threshold set

(“HIGH VTI” alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

Min VTI and Max VTI are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.

It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.

VTE (Min and/or Max Alarm Settings) – EXPIRED TIDAL VOLUME

A Min and/or Max Tidal volume expired by the patient can always be set but can only be used in a double limb circuit configuration.

These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE” alarm) or greater than the maximum threshold set

(“HIGH VTE” alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two.

VTE is displayed when ventilating with an exhalation valve.

Setting Min VTE and Max VTE is not mandatory (they can be set to “OFF”) , but the display of the measured value is always active in double limb configuration.

Max Leak

Max Rtot (Max Alarm Setting) – TOTAL BREATH RATE

The maximum rate threshold setting is used to warn of hyperventilation or autotriggering of the

ventilator. This setting is used to trigger the “HIGH RATE” alarm. Refer to chapter 5, “Alarms and

DISCONNECTION“ alarm. Refer to chapter 5, “Alarms and Troubleshooting”

The Max Rtot threshold must always be set at least 5 bpm higher than the Rate. If the Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm.

Setting the Max Rtot is not mandatory (it can be set to “OFF”) , but the measured value is always displayed.

FIO

(Min and/or Max Alarm Settings) – FRACTION OF INSPIRED OXYGEN

An FIO

sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.

Min and Max FIO

thresholds can be set to trigger “LOW FIO

” or “HIGH FIO

” alarms.

Min and Max FIO

thresholds are related and their settings must maintain a minimum difference of

10% between the two.

Min and Max FIO

settings can be set to OFF if an FIO

2 sensor is not connected. Settings are automatically restored once a sensor is reconnected.

These settings are the same for all ventilation modes.

Clinician’s Manual

3-13

Operating Parameters

3.4 V A/C Mode Parameters and Setting Ranges

The menus in the V A/C (Volume Assisted/Controlled) ventilation mode are shown in

Figure 3-7

PB560C12

PB560C13

3-14

Figure 3-7. Menus in the V A/C Mode

The ventilation parameters that are adjustable in the V A/C mode are shown in

Table 3-7 on page 3-14.

Table 3-7. Ventilation Parameters in V A/C Ventilation Mode

Name

PEEP

Ramp Pattern

Rate

Units

ml cmH

O, mbar or hPa

– bpm

Min.

Value

OFF

Max.

Value

2000

Adjustment

Resolution

–

Default

Value

500

OFF

I:E

(I/T)

I Sens

Sigh a

Rate

Sigh Vt

–

(%)

–

1/4

(20%)

1.0

1/1

(50%)

250

2.0

1/0.1

(1%)

0.1

1/2

(33%)

1 a. When set to YES, Sigh Vt and Sigh Rate are displayed. A Sigh Rate of 50 means a sigh is delivered every 50 breaths.

Linked

Parameters

Rate

Min VTE

Max VTE

Vt Sigh

Min PIP

Max PIP

–

Max Rtot

–

The alarm parameters adjustable in V A/C mode are as follows:

Table 3-8. V A/C Mode Alarm Parameters

Name

Min PIP

Units

Min.

Value

Max.

Value

Adjustment

Resolution

Max PIP

Min VTE cmH

O, mbar or hPa cmH

O, mbar or hPa ml

1,990

Default

Value

300

Linked

Parameters

PEEP

Max PIP

PEEP

Min PIP

Clinician’s Manual

Operating Parameters

Table 3-8. V A/C Mode Alarm Parameters (Continued)

Name

Max VTE

Max Rtot

Min FIO

Max FIO

Units

ml bpm

Min.

Value

Max.

Value

3,000

100

Adjustment

Resolution

Default

Value

1000

OFF

Linked

Parameters

Rate

Max FIO

Min FIO

Vt – VOLUME CONTROL

Vt allows you to set the tidal volume to be delivered to the patient at each inspiratory phase.

For physiological and safety reasons, the Vt setting is limited by the settings of Insp Time and Rate.

The ratio of Vt to Insp Time (Vt / Insp Time) is [3< (Vt x 60) / (Insp Time x 1000) < 100].

Warning

Ensure that the patient circuit is appropriate for the tidal volume setting (tube Ø 22 mm for adults, and Ø 15 mm for pediatric tidal volumes lower than 200 ml).

PEEP – POSITIVE END EXPIRATORY PRESSURE

PEEP allows you to determine the level of pressure maintained during the exhalation phase.

The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”).

Ramp Pattern – FLOW SHAPE

This parameter is used to adjust the flow distribution shape (or ramp pattern) during the inspiratory phase.

The three flow patterns available are:

• Ramp Pattern: (square waveform) or constant flow

• Ramp Pattern:

Decelerated (sawtooth waveform) or decreasing flow.

Sinusoidal flow

Rate – RESPIRATORY RATE

Rate allows you to define the frequency of ventilation cycles triggered by the ventilator.

If the patient actuates the inspiratory trigger, Total Rate may increase.

For physiological and efficiency reasons, Rate setting is limited by the settings of Vt and I:E (I/T).

I:E (I/T) Ratio – INSPIRATION AND EXHALATION RATIO

I:E allows you to determine the ratio between the inspiratory breath phase duration and the exhalation breath phase duration.

I/T allows you to determine the ratio between the inspiratory breath phase duration and the total breath duration. (inhalation + exhalation)

Note:

Insp Time is not a setting and is displayed as Ti when the I:E or I/T ratio is adjusted.

Clinician’s Manual

3-15

Operating Parameters

I Sens – INSPIRATORY TRIGGER SENSITIVITY

I Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.

The sensitivity levels decrease from 1P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.

I Sens 1 (P) = Bias flow + (0.4 lpm to 1 lpm) (P = Pediatric use)

I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)

I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)

I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)

I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)

The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO

The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow. I Sens can be set to OFF.

Warning

Sigh VT

A sigh is an increased volume of gas delivered to the patient at a set rate. i.e. every 50 breaths. The

Vt multiplied by Sigh Vt gives the amount of volume delivered to the patient during a Sigh.

Sigh Rate

Sigh Rate is the frequency with which Sigh breaths are delivered.

PIP (Min and Max Alarm Settings) – PEAK INSPIRATORY PRESSURE

A minimum and maximum inspiratory pressure alarm threshold must be set.

The Min PIP (or Low Pressure) setting determines the trigger threshold for the “PATIENT

. If this pressure level is not reached during a fixed time, the alarm is triggered.

Warning

The setting of the LOW PIP alarm must be adjusted for the patient, but must also be set high enough to allow the “PATIENT DISCONNECTION” alarm to trigger properly. Perform the Low

Pressure Test (refer to section F.1, “Low Pressure Test,” on page F-1 ) to ensure the LOW PIP alarm

is properly set.

The Max PIP or Max Pressure setting determines the level of pressure which is not to be exceeded during the inspiratory phase. Once this level is reached, inspiration is terminated, ventilation

switches to exhalation, and a “High PIP“ alarm is triggered. Refer to chapter 5, “Alarms and

(“HIGH VTE“ alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

The difference between the Min PIP and Max PIP settings is limited to a minimum of 8 mbar.

This setting is also limited by the setting of PEEP; thus, the Min PIP setting must exceed the PEEP setting by at least 2 mbar. In addition, the Max PIP setting must exceed the PEEP setting by at least

10 mbar. A change in the PEEP level may lead to automatic changes in the Min PIP and/or Max PIP thresholds, in order to maintain these setting differences.

3-16

Clinician’s Manual

Operating Parameters

VTE (Min and/or Max Alarm Settings) – EXPIRED TIDAL VOLUME

Minimum and/or maximum expired tidal volume settings are adjustable, but can only be used with a double limb circuit configuration.

These thresholds can be set to trigger an alarm if the tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE“ alarm) or greater than the maximum threshold set

Min VTE and Max VTE are linked to Vt so that Vt must be greater than Min VTE by at least 10 ml but lower than Max VTE by at least 10 ml.

If Vt is changed, Min VTE and Max VTE are automatically readjusted so that the difference between them is always maintained.

VTE is displayed when ventilating with an exhalation valve.

Setting Min VTE and Max VTE is not mandatory (they can be set to “OFF“, which is the default setting), but the measured value is always displayed when using double limb configurations.

Max Rtot (Max Alarm Setting) – TOTAL BREATH RATE

The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering.

Its setting is used to trigger the “HIGH RATE“ alarm. Refer to chapter 5, “Alarms and

mode are shown in Figure 3-8 .

When set, the Max Rtot threshold must always exceed the Rate setting by at least 5 bpm. If the

Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of

5 bpm.

Setting the Max Rtot is not mandatory (it can be set to “OFF“, the default setting), but the measured value is always displayed.

FIO

(Min and/or Max Alarm Settings) – FRACTION OF INSPIRED OXYGEN

An FIO

sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.

Min and Max FIO

thresholds can be set to trigger “LOW FIO

” or “HIGH FIO

” alarms.

FIO

Min and FIO

Max thresholds are related and their settings must maintain a minimum difference of 10% between the two.

Min and Max FIO

settings can be set to OFF if an FIO

2 sensor is not connected. Settings are automatically restored once a sensor is reconnected.

These settings are the same for all ventilation modes.

Clinician’s Manual

3-17

Operating Parameters

3.5 P SIMV Mode Parameters and Setting Ranges

The menus in the P SIMV (Synchronised Intermittent Mandatory Ventilation Pressure) ventilation

PB560C15

PB560C14

Figure 3-8. Menus in P SIMV Ventilation Mode

Table 3-9

shows the adjustable Ventilation parameters in P SIMV mode.

Table 3-9. Ventilation Parameters in P SIMV Ventilation Mode

Name

P Control

Min.

Value

Max.

Value

Adjustment

Resolution

P Support

PEEP

Rate

Units

cmH

O, mbar or hPa cmH

O, mbar or hPa bpm

OFF

Default

Value

OFF

Insp Time s 0.3

2.4

0.1

1.5

Linked

Parameters

PEEP

E Sens

I Sens

Rise Time

Apnea Time

– s

–

5 (-95)

95 (-5)

Auto

P Support

P Control

PIP

Max Rtot

Insp Time

Rate

Apnea Time

–

Backup R

I:E (I/T)

3-18

Clinician’s Manual

Operating Parameters

Table 3-10 shows the adjustable alarm parameters in P SIMV mode.

Table 3-10. Alarm Parameters in P SIMV Ventilation Mode

Name

Min VTI

Max VTI

Min VTE

Max VTE

Max Rtot

Min FIO

Max FIO

Units

ml ml ml ml bpm

Min.

Value

Max.

Value

2000

3000

1990

3000

100

Adjustment

Resolution

Default

Value

300

2000

300

1000

OFF

Links

Max VTI

Min VTI

Max VTE

Min VTE

Rate

Max FIO

Min FIO

P Control – PRESSURE CONTROL

When Relative Pressure is set to YES in the Setup Menu, P Control allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of controlled breaths.

In this configuration, the sum of P Control and PEEP must not exceed 55 mbar.

When Relative Pressure is set to OFF in the Setup Menu, P Control allows you to determine inspiratory Absolute pressure of controlled breaths.

In this configuration, P Control and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

P Support – PRESSURE SUPPORT

When Relative Pressure is set to YES in the Setup Menu, P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of spontaneous breaths.

In this configuration, the sum of P Support and PEEP must not exceed 55 mbar.

When Relative Pressure is set to OFF in the Setup Menu, P Support allows you to determine inspiratory Absolute pressure of spontaneous breaths.

In this configuration, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

PEEP – POSITIVE END EXPIRATORY PRESSURE

PEEP allows you to determine the level of pressure maintained during the exhalation phase.

When Relative Pressure is set to YES in the Setup Menu, the sum of P Control or P Support and

PEEP must not exceed 55 mbar.

When relative pressure is set to OFF, P Control or P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.

In leak configuration, the minimum PEEP setting is 4 mbar.

Clinician’s Manual

3-19

Operating Parameters

Rate – RESPIRATORY RATE

R-Rate is the rate at which the ventilator control pressure cycles are initiated, excluding apnea phases.

Rate and Insp Time are related so that if Rate is greater than 12 bpm, then Insp Time must be between 20% and 80% of the breath cycle duration as determined by Rate:

Insp Time < 0.33 x 60 /R Rate if Rate ≥ 8.

Insp Time ≤



2.4 if Rate < 8.

Note:

• During apnea ventilation, the ventilator delivers controlled breaths according to a backup rate

(Backup R) as long as no inspiratory trigger has been detected.

• The Backup R value applied depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and is equal to the Rate value if Rate is greater than 8 bpm.

Insp Time – INSPIRATORY TIME CONTROLLED

Insp Time allows you to determine the duration of the inspiratory phase of controlled breaths triggered by the ventilator and is limited to a 1:2 I:E ratio.

Backup R and Insp Time are related.

I Sens – INSPIRATORY TRIGGER SENSITIVITY

I Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath.

The sensitivity levels decrease from 1P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.

I Sens 1 (P) = Bias flow + (0.4 lpm to 1 lpm) (P = Pediatric use)

I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)

I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)

I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)

I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)

The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO

The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms , depending on the preceding peak inspiratory flow. I Sens can be set to OFF.

Warning

Apnea Time

3-20

Clinician’s Manual

Operating Parameters

The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (Auto = Maximum value between 3 seconds and 60/Backup R or Auto = 30 if Backup R = OFF).

Note:

• During apnea ventilation, the ventilator delivers machine controlled breaths according to a backup rate

(Backup R) – as long as no inspiratory trigger has been detected.

• The Backup R value applied depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the Rate value if Rate is greater than 8 bpm.

I Time (Min and Max Settings)

The minimum (Min I Time) and maximum (Max I Time) duration of the inspiratory phase cannot be set in V SIMV or P SIMV mode. In both the V SIMV and P SIMV modes, the Min I Time defaults to a setting equal to RISE TIME + 300 ms and the Max I Time defaults to the lesser of 3 seconds or

30/Rate.

Rise Time

The Rise Time during the inspiratory phase can be set in P SIMV mode and the range is 1-5. The device is configured with a default Rise Time setting of two (2) (or a pressure rise time of 200 ms to

800 ms).

E Sens – EXHALATION SENSITIVITY

E sens is available in the P SIMV, V SIMV, and PSV modes. In CPAP, E Sens is defaulted to 25% and is not adjustable.

E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.

The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting.

The exhalation trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.

1:1.0, to ensure that the patient has enough time to exhale.

Clinician’s Manual

Figure 3-9.

Exhalation trigger sensitivity

Note:

Refer to chapter 7, “Operating Procedures” for positive and negative E Sens settings.

3-21

Operating Parameters

VTI (Min and/or Max Alarm Settings) – INSPIRATORY TIDAL VOLUME

It is possible to set a Min and/or Max Tidal Volume alarm threshold for the patient’s inspired tidal volume.

This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI“ alarm) or greater than the maximum threshold set (“HIGH VTI“

alarm). Refer to chapter 5, “Alarms and Troubleshooting”

Min VTI and Max VTI are related and their setting must maintain a minimum difference of 20 ml between them.

It is not mandatory to set the minimum and maximum VTI alarm limits. When the minimum and maximum VTI alarm limits are not set, the display will read “OFF” for these settings.

VTE (Min and/or Max Alarm Settings) – EXPIRED TIDAL VOLUME

A Min and/or Max Tidal volume expired by the patient can be set but can only be used in a double limb circuit configuration.

These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE“ alarm) or greater than the maximum threshold set

(“HIGH VTE“ alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between them.

VTE is displayed when ventilating with an exhalation valve.

Setting Min VTE and Max VTE is not mandatory (set to “OFF”), but the display of the measured value is always active in double limb configuration.

Max Rtot (Max Alarm Setting) – TOTAL BREATH RATE

The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering.

Its setting is used to trigger the “HIGH RATE“ alarm. Refer to chapter 5, “Alarms and

mode are shown in Figure 3-10

When set, the Max Rtot threshold must always exceed the Rate setting by at least 5 bpm. If the

Rate is readjusted, the Max Rtot is automatically readjusted to maintain a minimum difference of

5 bpm.

Setting the Max Rtot is not mandatory (it can be set to “OFF“, the default setting), but the measured value is always displayed.

FIO

(Min and/or Max Alarm Settings) – FRACTION OF INSPIRED OXYGEN

An FIO

sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient.

Min and Max FIO

thresholds can be set to trigger “LOW FIO

” or “HIGH FIO

” alarms.

Min and Max FIO

Max thresholds are related and their settings must maintain a minimum difference of 10% between the two.

Min and Max FIO

settings can be set to OFF if an FIO

sensor is not connected. Settings are automatically restored once a sensor is reconnected.

These settings are the same for all ventilation modes.

3-22

Clinician’s Manual

Operating Parameters

3.6 V SIMV Mode Parameters and Setting Ranges

The menus in the V SIMV (Synchronised Intermittent Mandatory Ventilation Volume) ventilation

PB560C16bis

PB560C17bis

Figure 3-10. Menus in V SIMV Ventilation Mode

Table 3-11 shows the adjustments and limits in V SIMV mode.

Table 3-11. Ventilation Parameters in V SIMV Mode

Name

Units

Min.

Value

Max.

Value

2000

Adjustment

Resolution

Default

Value

500

P Support

PEEP

Rate

Insp Time

E Sens

I Sens

Rise Time

Apnea Time s

– s

–

– cmH

O, mbar or hPa cmH

O, mbar or hPa bpm

OFF

0.3

5 (-95)

2.4

95 (-5)

0.1

OFF

1.5

Auto

Links

Min VTE

Max VTE

Insp Time

PEEP

Min PIP

Max PIP

P Support

Max PIP

Min PIP

Max Rtot

Insp Time

Rate

–

Rate

–

Backup R

Clinician’s Manual

3-23

Operating Parameters

Alarm parameters that are adjustable in the V SIMV mode menu and their adjustment limits are

listed in Table 3-12 .

Table 3-12. Alarm Parameters in the V SIMV Mode Menu

Name

Min PIP

Max PIP

Min VTE

Max VTE

Max Rtot

Min FIO

Max FIO

Units

cmH

O, mbar or hPa cmH

O, mbar or hPa ml ml bpm

Min.

Value

Max.

Value

1990

3000

100

Adjustment

Resolution

Default

Value

300

1000

OFF

Links

PIP

PEEP

Max PIP

PIP

PEEP

Min PIP

Max VTE

Min VTE

Rate

Max FIO

Min FIO

Vt – VOLUME CONTROL

Vt allows you to set the tidal volume delivered to the patient at each inspiration phase of intermittent or successive controlled breath cycles (triggered by the ventilator) in the event of patient apnea.

For physiological and safety reasons, the Vt setting is limited by the settings of Insp Time and Rate.

The ratio of Vt to Insp Time (Vt / Insp Time) must be 3 lpm < (Vt *60) / (60/Rate *I/T)

Insp Time*1000) < 100 lpm.

Note:

The Backup R value applied depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the Rate value if Rate is greater than 8 bpm.

Warning

Ensure that the patient circuit is appropriate for the tidal volume setting (tube Ø 22 mm for adults, and Ø 15 mm for pediatric tidal volumes lower than 200 ml).

P Support – PRESSURE SUPPORT

When Relative Pressure is set to YES in the Setup Menu, P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of spontaneous breaths.

In this configuration, the sum of P Support and PEEP must not exceed 55 mbar.

When Relative Pressure is set to OFF in the Setup Menu, P Support allows you to determine inspiratory Absolute pressure of spontaneous breaths.

In this configuration, P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration.

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Operating Parameters

PEEP – POSITIVE END EXPIRATORY PRESSURE

PEEP allows you to determine the level of pressure maintained during the exhalation phase.

When Relative Pressure is set to YES in the Setup Menu, the sum of P Support and PEEP must not exceed 55 mbar.

The ventilation mode can be adjusted without PEEP (PEEP is nearly 0 mbar when set to “OFF”) in valve configuration.

In leak configuration, the minimum PEEP setting is 4 mbar.

Rate – RESPIRATORY RATE

Rate is the rate at which ventilator controlled breaths are triggered, excluding apnea ventilation.

Rate and Insp Time are related so that if Rate is greater than 8 bpm, then Insp Time must be

0.2 x 60 / Rate < Insp Time < 0.8 x 60 / Rate

Note:

• During apnea, ventilation, the ventilator delivers controlled breaths according to a backup rate

(Backup R) as long as no inspiratory trigger has been detected.

• The Backup R value depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and becomes equal to the Rate value if Rate is greater than 8 bpm.

Insp Time – INSPIRATORY TIME

Insp Time allows you to determine the inspiratory phase duration of ventilator controlled breaths.

For physiological and efficiency reasons, its setting is limited by those of Vt and Rate.

The ratio Vt/Insp Time must be between 3 litres and 100 litres [3 < (Vt x 60) / (InspTime x 1000) <

100].

Note:

The Backup R value depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and becomes equal to the Rate value if Rate is greater than 8 bpm.

I Sens – INSPIRATORY TRIGGER SENSITIVITY

I Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath.

The sensitivity levels decrease from 1P to 5: the lower the number, the more sensitive the trigger sensitivity. These levels correspond to differences in flow compared to the bias flow.

I Sens 1 (P) = Bias flow + (0.4 lpm to 1 lpm) (P = Pediatric use)

I Sens 2 = Bias flow + (0.7 lpm to 1.3 lpm)

I Sens 3 = Bias flow + (0.9 lpm to 1.5 lpm)

I Sens 4 = Bias flow + (1.0 lpm to 1.6 lpm)

I Sens 5 = Bias flow + (1.2 lpm to 1.8 lpm)

The bias flow consists of turbine flow through the patient circuit, during the exhalation phase, that helps the patient avoid rebreathing exhaled gas (CO

The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms, depending on the preceding peak inspiratory flow.

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Operating Parameters

Warning

Apnea Time

The APNEA TIME adjustment range shall be 1 to 60 seconds. The Ventilator shall enable the operator to set an auto-setting which shall automatically calculate the APNEA TIME according to the following: APNEA TIME = 60 / BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV modes.

The Apnea Time “AUTO” setting (in seconds) is calculated using the formula (Auto = Maximum value between 3 seconds and 60/Backup R or Auto = 30 if Backup R = OFF).

Note:

• During apnea ventilation, the ventilator delivers machine controlled breaths according to a backup rate

(Backup R) – as long as no inspiratory trigger has been detected.

• The Backup R value applied depends on the Rate setting. Hence, Backup R is at least equal to 8 bpm and takes the Rate value if Rate is greater than 8 bpm.

I Time (Min and Max)

30/Rate.

Ramp

The distribution shape (or flow pattern) of the flow rate during the inspiratory phase cannot be set in V SIMV mode. The device is configured by default with a square wave flow pattern that represents a constant flow rate .

Rise Time

The Rise Time during the inspiratory phase can be set in V SIMV mode and the range is 1-5. The ventilator has a default Rise Time of 2 (or a pressure rise time of 400 ms).

E Sens – EXHALATION SENSITIVITY

E Sens is available in the P SIMV, V SIMV, and PSV mode. E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath.

The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting.

The exhalation trigger is only taken into account after the Rise Time (which constitutes a default minimum inspiratory time) has elapsed.

1:1.0, to ensure that the patient has enough time to exhale.

Note:

Refer to chapter 7, “Operating Procedures” for positive and negative E Sens settings.

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Operating Parameters

Figure 3-11.

Exhalation trigger sensitivity

PIP (Min and Max Alarm Settings) – PEAK INSPIRATORY PRESSURE

A minimum and maximum pressure alarm threshold must be set.

The Min PIP (or Min Pressure) setting determines the trigger threshold for the “PATIENT

DISCONNECTION“ alarm. Refer to chapter 5, “Alarms and Troubleshooting”

Warning

The setting of the LOW PIP alarm must be adjusted for the patient, but must also be set high enough to allow the “PATIENT DISCONNECTION” alarm to trigger properly. Perform the Low

Pressure Test (refer to section F.1, “Low Pressure Test,” on page F-1 ) to ensure the LOW PIP alarm

is properly set.

The Max PIP or Max Pressure setting determines the level of pressure which is not to be exceeded during the inspiratory phase. When this level is reached, inspiration is terminated, the device

switches to exhalation, and a “High PIP“ alarm is triggered. Refer to chapter 5, “Alarms and

threshold set (“HIGH VTI“ alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

The difference between the Min PIP and Max PIP settings is limited to a minimum of 8 mbar. Their settings are also limited by that of PEEP; thus, Min PIP must be greater than PEEP by at least 2 mbar and Max PIP must be greater than PEEP by at least 10 mbar. A change in the PEEP level may lead to automatic changes in the Min PIP and/or Max PIP thresholds so that these differences are always maintained.

VTI (Min and/or Max Alarm Settings) – INSPIRATORY TIDAL VOLUME

It is possible to set a Min and/or Max alarm threshold for the inspired tidal volume received by the patient.

VTI allows you to trigger an alarm during breath delivery if the tidal volume inspired by the patient is lower than the minimum threshold set (“LOW VTI“ alarm) or greater than the maximum

Min VTI and Max VTI are related to Vt such that Vt must be higher than Min VTI by at least 10 ml, but lower than Max VTI by at least 10 ml.

If Vt is changed, Min VTI and Max VTI are, if necessary, automatically readjusted so that the difference between them is maintained.

Setting Min VTI and Max VTI is not mandatory (set to “OFF“), but the display of the measured value is always active in a double limb configuration.

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Operating Parameters

VTE (Min and/or Max Alarm Settings) – EXPIRED TIDAL VOLUME

A double limb patient circuit configuration must be used when setting the Min and/or Max Tidal volume alarm limits.

These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set (“LOW VTE“ alarm) or greater than the maximum threshold set

(“HIGH VTE“ alarm). Refer to chapter 5, “Alarms and Troubleshooting” .

Min VTE and Max VTE are linked to Vt such that Vt must be greater than Min VTE by at least 10 ml but lower than Max VTE by at least 10 ml.

If Vt is changed, Min VTE and Max VTE are, if necessary, automatically readjusted so that the difference between them is always maintained.

VTE is displayed when ventilating with an exhalation valve.

Setting Min VTE and Max VTE is not mandatory (each can be set to “OFF“) , but the measured value is always displayed using a double limb patient circuit.

Max Rtot (Max Alarm Setting) – TOTAL BREATH RATE

The maximum rate threshold set is used to monitor and alarm for ventilator autotriggering.

The alarm setting is used to trigger the “HIGH RATE” alarm. Refer to chapter 5, “Alarms and