Аппарат пуритан беннет 560 инструкция

Table of Contents

2Ventilator Overview

Table of Contents

3Alarms and Troubleshooting

4Installation and Assembly

Table of Contents

5Operating Procedures

6Internal Battery

7Cleaning

8Routine Maintenance

ASpecifications

Table of Contents

BModes of Ventilation

COperational Verification Checklist

DUnpacking and Preparation

EAlarms Tests

GGlossary

List of Figures

Figure 1-1. Locations of Labels—Top-Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25 Figure 1-2. Locations of Labels—Front-Left View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25 Figure 1-3. Location of Labels and Markings—Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26 Figure 1-4. Location of Labels—Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26 Figure 2-1. Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Figure 2-2. Back Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Figure 2-3. Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Figure 2-4. Ventilation Menu Display (on standby at left; during ventilation at right) . . . . . . . . . . . . . . . . . . 2-8 Figure 2-5. Alarm Menu (on standby at left; during ventilation at right) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9 Figure 2-6. Waveforms Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Figure 2-7. USB Memory Device Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11 Figure 3-1. Front Panel (Alarm Control Key). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Figure 3-2. Alarm Messages (in Ventilation menu at left, in Alarm menu at right) . . . . . . . . . . . . . . . . . . . . . . 3-3 Figure 3-3. Accessing the Alarm Logs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Figure 3-4. Alarm Logs Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Figure 3-5. Alarm Logs Screen (no alarm activated). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Figure 3-6. Pausing the Audible Portion of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Figure 3-7. Ventilator Screen (alarm paused indicator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Figure 3-8. Reactivating Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Figure 3-9. Alarm Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Figure 4-1. The Power Cable Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Figure 4-2. Inserting the Power Cable Holder into the Notch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Figure 4-3. Power Cable Connected to the Ventilator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Figure 4-4. Power Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Figure 4-5. Connecting the DC Power Cable to the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Figure 4-6. Connecting the Ventilator to an External DC Power Source . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7 Figure 4-7. Single-Limb Patient Circuit With Exhalation Valve (including accessories). . . . . . . . . . . . . . . . . 4-10 Figure 4-8. Closeup of Exhalation Valve Tube and Proximal Pressure Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11 Figure 4-9. Double-Limb Patient Circuit (including accessories). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 Figure 4-10. Closeup of Exhalation Valve Tube and Proximal Pressure Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13 Figure 4-11. Close-up of Exhalation Bacteria Filter Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14 Figure 4-12. Single-Limb Patient Circuit Without Exhalation Valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14 Figure 4-13. Air Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16 Figure 4-14. Bacteria Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17 Figure 4-15. Humidifier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18 Figure 4-16. Removing the Exhalation Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19 Figure 4-17. Rear Panel Oxygen Inlet Port and Coupler. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21 Figure 4-18. Connecting the Oxygen Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22 Figure 4-19. Disconnecting the Oxygen Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23 Figure 4-20. Connecting the FiO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24 Figure 4-21. Using the Dual Bag as a Backpack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26 Figure 4-22. Using the Dual Bag on a Wheelchair (with double-limb circuit on left; with

single-limb circuit on right) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27 Figure 4-23. Using the Dual Bag in a Personal Vehicle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

List of Figures

Figure 4-24. Mounting the Ventilator on the Utility Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 Figure 4-25. Securing the Ventilator on the Utility Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 Figure 4-26. Puritan Bennett™ 560 Ventilator Mounted on Utility Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 Figure 5-1. Turning on the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 Figure 5-2. VENTILATION ON/OFF Button and Standby Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Figure 5-3. Welcome Menu Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 Figure 5-4. Ventilation Menu Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4 Figure 5-5. Selecting the USB Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Figure 5-6. Selecting Transfer Continuously . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6 Figure 5-7. Selecting Transfer Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7 Figure 5-8. Prompt to Start Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 Figure 5-9. Starting Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10 Figure 5-10. Stopping Ventilation (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10 Figure 5-11. Stopping Ventilation (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Figure 6-1. Internal Battery Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Figure 6-2. Battery Reserve Capacity as a Percentage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Figure 6-3. Battery Reserve Capacity in Hours and Minutes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Figure 6-4. Power Indicators when Charging the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Figure 7-1. Removing the Exhalation Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Figure 7-2. Puritan Bennett ™ 560 Ventilator Pneumatic Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Figure 8-1. Blocking the Patient Circuit (single-limb circuit at left; double-limb circuit at right) . . . . . . . . 8-2 Figure 8-2. Calibrating the Exhalation Flow Sensor (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Figure 8-3. Calibrating the Exhalation Flow Sensor (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Figure 8-4. Calibrating the Exhalation Flow Sensor (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Figure 8-5. Calibrating the FiO2 Sensor (1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 Figure 8-6. Calibrating the FiO2 Sensor (2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 Figure 8-7. Calibrating the FiO2 Sensor (3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6 Figure 8-8. Replacing the Air Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Figure E-1. Ventilator Screen (Patient Disconnection alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2 Figure E-2. Ventilator Screen (High Leakage alarm shown). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3 Figure E-3. Circuit Check Screen (before starting). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4 Figure E-4. Blocking the Patient Circuit (single-limb circuit at left; double-limb circuit at right) . . . . . . . . E-5 Figure E-5. Circuit Check (running) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5 Figure E-6. Circuit Check (complete, passed) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Figure E-7. Circuit Check (complete, failed) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-6 Figure E-8. Ventilator Screen (AC Power Disconnection alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-8 Figure E-9. Blocking the Patient Circuit (single-limb circuit at left; double-limb circuit at right) . . . . . . . . E-8 Figure E-10. Ventilator Screen (Occlusion alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-9 Figure E-11. Ventilator Screen (AC Power Disconnection alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-10

List of Tables

Table 1-1. Ventilator Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 Table 1-2. Ventilator Labels and Markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24 Table 3-1. Overview of Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9 Table 3-2. Alarms and Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 Table 3-3. Additional Troubleshooting and Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25 Table 5-1. USB Memory Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Table 5-2. Ventilator to USB Device Data Transfer Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8 Table 6-1. Internal Battery Reserve Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Table 7-1. Approved Cleaning Solutions for Exterior Ventilator Surfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Table 8-1. Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 Table A-1. Physical Description (excluding accessories) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 Table A-2. Electrical Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 Table A-3. Internal Lithium Ion Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Table A-4. Power Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Table A-5. Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Table A-6. Audio Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Table A-7. Performance Parameter Specifications and Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Table A-8. Monitored Parameter Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Table A-9. Ventilator Range, Resolution, and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Table A-10. Environmental Conditions for Storage or Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 Table A-11. Environmental Conditions for Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 Table A-12. USB Memory Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 Table A-13. Data Transfer Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8 Table A-14. Airway Resistances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Table A-15. Patient Circuit Resistances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Table A-16. Air Inlet Resistance (Filter) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Table A-17. Oxygen Inlet Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Table A-18. Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Table A-19. Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11 Table A-20. Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11 Table A-21. Electromagnetic Immunity—Conducted and Radiated RF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12 Table A-22. Compliant Cables and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12 Table C-1. Operational Verification Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 Table D-1. Items Included with Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 Table F-1. List of Consumables and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1 Table F-2. List of Circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2

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 authorized 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 meaning of the symbol at left, 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 SolvITSM Center Knowledge Base by clicking the link at www.medtronic.com/covidien/support/solvit- center-knowledge-base/. 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.

Service Centers

1Safety Information

1.1Definitions

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.

Caution

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.

:Note:

Many ventilator functions are not accessible when the Locking key is enabled. For additional assistance contact your clinician or equipment representative.

1.2Warnings

1.2.1General Warnings Regarding Use of Equipment

<WARNING:

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

<WARNING:

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

<WARNING:

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

<WARNING:

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.

<WARNING:

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 ventilatordependent patients.

<WARNING:

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.

<WARNING:

Always have immediate access to an alternative means of ventilation, which is ready for use, to avoid patient death or serious injury.

<WARNING:

The ventilator must not be used with flammable anesthetic substances.

<WARNING:

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.

<WARNING:

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.

<WARNING:

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

Warnings

<WARNING:

Refer to this manual for equipment compatible with this ventilator. It may be unsafe to interconnect this equipment with other equipment not described in this manual.

<WARNING:

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.

<WARNING:

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.

<WARNING:

Verify the functionality of the alarms before connecting the patient to the ventilator. Refer to Appendix

E, Alarms Tests.

<WARNING:

If the ventilator fails the alarm tests or if you cannot complete the tests, refer to Chapter 3, Alarms and Troubleshooting or call your equipment supplier or Covidien.

<WARNING:

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.

<WARNING:

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.

<WARNING:

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

<WARNING:

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 (TO PATIENT) port—or both ports if a double-limb circuit is used—is recommended. Refer to Chapter 7, Cleaning.

<WARNING:

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.

<WARNING:

Do not connect the ventilator to any device other than a PC with a dedicated compatible Puritan Bennett™ software package.

<WARNING:

The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of conditions. For a detailed understanding of ventilator operations, be sure to thoroughly read this manual before attempting to use the ventilator system.

1.2.2Warnings Regarding Installation and Environment of Use

<WARNING:

Even though the Puritan Bennett™ 560 ventilator meets current safety standards, the internal Lithiumion 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.

<WARNING:

To minimize the risk of damage, you must use the ventilator’s dual bag to transport the ventilator. Ventilator accessories are listed in Table F-1.

<WARNING:

When using the ventilator in a carrying case, only use a carrying case that is listed in the instructions for use to prevent adverse ventilator performance, which can consequently result in patient death.

<WARNING:

Regularly clean the ventilator’s dual bag according to manufacturer’s recommendations.

<WARNING:

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

Warnings

<WARNING:

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.

<WARNING:

To ensure correct and lasting operation of the device, ensure that the ventilator is installed and operated in the environmental conditions recommended in Appendix A, Specifications.

<WARNING:

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

<WARNING:

Do not operate the ventilator in a magnetic resonance imaging (MRI) environment. Doing so could cause a ventilator malfunction.

<WARNING:

Do not operate the ventilator in the presence of active high frequency (HF) surgical equipment. Doing so could cause a ventilator malfunction.

<WARNING:

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.

<WARNING:

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.

<WARNING:

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 patient circuit to the patient provides for a secure, comfortable fit.

<WARNING:

Ensure that the ventilator is not positioned or located such that the AC and DC connections at the back of the ventilator are difficult to access.

<WARNING:

Do not cover the ventilator or place in a position that affects proper operation, e.g., blocking a front or lateral opening.

<WARNING:

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

<WARNING:

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

<WARNING:

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.

<WARNING:

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 stabilize in its operating environment for at least 2 hours prior to use. When the ambient temperature is 20°C, 2 hours are required to warm the ventilator from the minimum storage temperature or to cool the ventilator from the maximum storage temperature prior to use.

<WARNING:

If the ambient temperature where the device is operated is greater than 35°C (95°F), the temperature of the patient circuit or the flow supplied at the device outlet may exceed 41°C (106°F), and the patient circuit may reach up to 60°C (140°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.

<WARNING:

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

<WARNING:

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.

<WARNING:

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 8, 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.

<WARNING:

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

<WARNING:

Exercise care to avoid any potential significant risks of reciprocal interference posed by the ventilator and accessories during specific investigations or treatments.

1.2.3Warnings Regarding Electrical Power Supplies

<WARNING:

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

<WARNING:

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

<WARNING:

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.

<WARNING:

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 4.2, Connecting to External AC Power.

<WARNING:

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 A, Specifications.

<WARNING:

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.

<WARNING:

Due to the internal battery’s limited 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.

<WARNING:

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 section 4.3, Connecting to an External DC Power Source.

<WARNING:

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.

<WARNING:

When the Low Battery alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery.

<WARNING:

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

<WARNING:

Never expose any batteries to direct flame.

<WARNING:

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.

1.2.4Warnings Regarding Hoses and Accessories

<WARNING:

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

<WARNING:

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

<WARNING:

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.

<WARNING:

The patient circuit should not be changed during ventilation.

<WARNING:

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.

<WARNING:

Single use accessories should not be reused.

Warnings

<WARNING:

The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically (refer to section 7.3, Cleaning the Exhalation Block). The exhalation block should be changed every 4 months and cannot be reused with any other patient.

<WARNING:

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, a humidifier, to minimize drying of the patient’s airway and subsequent irritation and discomfort, must be used.

<WARNING:

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.

<WARNING:

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

<WARNING:

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

<WARNING:

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.

<WARNING:

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

<WARNING:

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

<WARNING:

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, use a recommended patient circuit; see Table F-2.

<WARNING:

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

<WARNING:

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

<WARNING:

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.

<WARNING:

Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett™ 560 ventilator.

<WARNING:

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. Take precautions when discarding the fluid in the water trap. Discard per local ordinance for proper disposal.

<WARNING:

Use of a nebulizer or humidifier can lead to an increase in the resistance of inspiratory and exhalation filters. Monitor the filters frequently for increased resistance or blockage.

<WARNING:

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.

<WARNING:

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.

<WARNING:

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.

<WARNING:

To ensure proper performance of the ventilator, use a patient circuit recommended by Covidien in this manual; refer to Chapter 4, Installation and Assembly and Appendix F, 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 meters (3.6 feet) to 2.0 meters (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

Warnings

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.

<WARNING:

To ensure proper performance of the ventilator, use only accessories (including oxygen accessories) approved and recommended by Covidien. See Appendix F, Parts and Accessories or contact your customer services.

<WARNING:

To reduce the likelihood of disconnection and to prevent adverse ventilator performance, use only accessories compatible with the ventilator. Compatibility is determined by reviewing the instructions for use of either the ventilator or the accessories.

<WARNING:

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.

1.2.5Warnings Regarding Settings

<WARNING:

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

<WARNING:

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.

<WARNING:

The CPAP mode does not provide a set respiratory rate. Do not use this mode for ventilator-dependent patients.

<WARNING:

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.

<WARNING:

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.

<WARNING:

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

<WARNING:

The ventilator offers a variety of breath delivery options. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and settings to use for that patient, based on clinical judgment, the condition and needs of the patient, and the benefits, limitations, and characteristics of the breath delivery options. As the patient’s condition changes over time, periodically assess the chosen modes and settings to determine whether those are best for the patient’s current needs.

<WARNING:

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

<WARNING:

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.

<WARNING:

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.

<WARNING:

The Min PIP alarm setting 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 to ensure the alarm is properly set.

<WARNING:

The Max Leak alarm setting must be adjusted for the patient, but must also be set low enough to allow the High Leakage alarm to trigger properly. Perform the max leak test to ensure the alarm is functioning properly. This alarm only applies to leak configuration (NIV).

<WARNING:

If Apnea Time is set to a value higher than 60/Control R then the Apnea alarm will not activate.

<WARNING:

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

Warnings

<WARNING:

The Apnea alarm should be set to YES for ventilator dependent patients.

<WARNING:

Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not to activate during ventilation, which reduces its efficacy for monitoring the patient and alerting the clinician to situations that may require intervention.

<WARNING:

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

<WARNING:

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

<WARNING:

Do not pause, disable, or decrease the volume of the ventilator’s audible alarm if patient safety could be compromised.

<WARNING:

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.

<WARNING:

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.

<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 0P, the most sensitive mode, is recommended for pediatric use. However, for an adult, this setting may result in autotriggering.

<WARNING:

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.

1.2.6Warnings Regarding PC Connection and USB Memory Devices

<WARNING:

Do not connect the ventilator to any device other than a PC with a dedicated compatible Puritan Bennett™ software package.

<WARNING:

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

<WARNING:

USB connections are not intended for connection to any devices other than the specified USB flash storage (see section 5.2.1, USB Memory Device Specifications).

1.2.7Warnings Regarding Maintenance

<WARNING:

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.

<WARNING:

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

<WARNING:

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.

<WARNING:

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

<WARNING:

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

<WARNING:

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.

Warnings

<WARNING:

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.

<WARNING:

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 7-1.

<WARNING:

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.

<WARNING:

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

<WARNING:

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.

<WARNING:

The exhalation block is intended for single use by a single patient . It may periodically be cleaned, but it cannot be disinfected or sterilized. To maintain good measurement quality when used continuously, clean the exhalation block periodically (refer to section 7.3, Cleaning the Exhalation Block). The exhalation block should be changed every 4 months and cannot be reused with any other patient.

<WARNING:

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

<WARNING:

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 8.3, Calibrating the Exhalation Flow Sensor.

<WARNING:

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 4, Installation and Assembly.

<WARNING:

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 (TO PATIENT) port—or both ports if a double-limb circuit is used—is recommended. Refer to Chapter 7, Cleaning.

<WARNING:

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 8, 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.

<WARNING:

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.

<WARNING:

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.

<WARNING:

The maximum recommended shelf life of the internal battery is 2 years. Do not use a battery that has been stored for 2 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.

<WARNING:

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

<WARNING:

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.

<WARNING:

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.

Warnings

<WARNING:

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.

1.2.8Warnings Regarding Oxygen

<WARNING:

The ventilator must not be used with flammable anesthetic substances.

<WARNING:

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.

<WARNING:

Strictly follow the instructions provided in section 4.8.2, Connecting the Oxygen Supply, which include the use of a flow regulator and special oxygen connector.

<WARNING:

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.

<WARNING:

The Puritan Bennett™ 560 ventilator can be used with an optional oxygen analyzer with minimum and maximum concentration alarms. Always measure the delivered oxygen with a calibrated oxygen analyzer (FiO2 kit) that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.

<WARNING:

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.

<WARNING:

Ensure that the oxygen supply pressure to the machine never exceeds 7 psi (50 kPa) or a flow of 15 lpm. For volume and sensitivity tolerances, refer to Table A-7.

<WARNING:

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.

<WARNING:

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.

<WARNING:

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

<WARNING:

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

<WARNING:

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

<WARNING:

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).

<WARNING:

The oxygen supply hose ages even when it is not in use and should be replaced periodically. Follow the expiration date, if any.

<WARNING:

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

<WARNING:

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.

<WARNING:

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

<WARNING:

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.

Symbols and Markings

1.2.9Warnings Regarding Electromagnetic Interference

<WARNING:

The Puritan Bennett™ 560 ventilator requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix A, 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 A.10, Manufacturer’s Declaration.

<WARNING:

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ventilator, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

<WARNING:

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 item 5 in Table 1-2.

It is mandatory to read, understand, and follow these instructions before using the Puritan Bennett™ 560 Ventilator (ISO 7010-M002). This symbol appears on the ventilator’s air inlet label, see item 5 in Table 1-2.

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 item 5 in Table 1-2.

Direct current, DC (IEC 60417-5031).

This symbol appears on the ventilator’s front panel and back panel; see Figure 1-1, and item 9 in Figure 1-3.

Alternating current, AC (IEC 60417-5032).

This symbol appears on the ventilator’s front panel and back panel; see item 8 in Figure 1-3, and item 10 in

Figure 2-3 (page 2-7).

Internal battery.

This symbol appears on the ventilator’s front panel; see item 10 in Figure 2-3 (page 2-7).

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

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 item 5 in Table 1-2.

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

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, 2, indicates protection against water dripping or falling vertically when the enclosure is tilted at an angle up to 15° from its normal position, as well as an environment featuring water vapor condensation and/or light rain.

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

CSA—Canadian Standards Association.

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

CE—Conformity European

Signifies compliance with the medical device directive 93/42/EEC as amended by 2007/47/EC.

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

This combined symbol appears on the ventilator’s UP/UNFREEZE key; see item 4 in Figure 2-3 (page 2-7).

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 combined symbol appears on the ventilator’s DOWN/FREEZE key; see item 6 in Figure 2-3 (page 2-7).

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 ENTER key; see item 5 in Figure 2-3 (page 2-7).

This key is used to confirm command actions.

This combined symbol appears on the ventilator’s ALARM CONTROL key; see item 2 in Figure 2-3 (page 2-7).

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

For more information, see Appendix E, Alarms Tests.

This symbol appears on the ventilator’s MENU key; see item 7 in Figure 2-3 (page 2-7).

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 VENTILATION ON/OFF button; see item 8 in Figure 2-3 (page 2-7).

This button 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 item 1 in Figure 1-1.

FROM PATIENT port (double-limb option).

This symbol appears on the front left of the ventilator, adjacent to the FROM PATIENT port; see item 4 in Figure 1-1.

Patient proximal pressure port.

This symbol appears on the front right of the ventilator, adjacent to the proximal pressure and TO PATIENT ports; see Figure 1-1, and item 3 in Figure 1-4.

Symbols and Markings

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

Exhalation valve pilot port.

This symbol appears on the front right of the ventilator, adjacent to the exhalation valve and TO PATIENT ports, indicating the connection of the tubing between the patient circuit exhalation valve; see Figure 1-1, and item 3 in Figure 1-4.

Oxygen inlet.

This marking appears on the back panel of the ventilator, adjacent to the oxygen inlet port; see item 2 in Figure 1-3.

Nurse call connection.

This symbol appears on the back panel of the ventilator, adjacent to the nurse call receptacle; see item 12 in

Figure 1-3.

Note: Nurse call is not intended for use in the home environment.

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 item 2 in Figure 2-2 (page 2-6).

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 item 2 in Figure 2-2 (page 2-6).

Software lock enabled.

This symbol appears at upper left in the ventilator’s LCD display when the keyboard Locking key is enabled.

Internal battery.

This symbol appears at top center in the ventilator’s LCD display to indicate that the ventilator is being powered by its internal battery. See item 1 in Figure 2-4 (page 2-8), and Chapter 6, Internal Battery, for more information.

Pressure rise times (inspiratory phase) parameter.

These symbols appear on the ventilation mode menu screens. 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. 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.

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 5, Operating Procedures.

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

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.

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. See item 5 in Table 1-2.

Year of manufacture.

Manufacturer.

Authorized representative.

Audio paused (ALARM CONTROL key pressed once).

This symbol means the sounding of audible alarms is currently disabled. This period lasts 60 seconds. For more information, see section 3.5, Pausing the Audible Portion of Alarms.

Alarm paused (ALARM CONTROL key pressed twice).

This symbol means one or more alarms have been paused, or reset/canceled. The alarm is paused until the alarm condition is corrected and the condition reoccurs. For more information, see section 3.6, Pausing and Resetting Alarms.

Alarm off (Apnea off).

This symbol means that the Apnea alarm has been set to OFF in the Preferences menu. For more information, see section 3.6, Pausing and 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.”

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 item 11 in Figure 1-3.

Symbols and Markings

Table 1-1. Ventilator Symbols (Continued)

Symbols Descriptions

PC connection.

This symbol indicates a port that can be used by authorized Covidien product service personnel or Covidien service personnel for software maintenance. See item 10 in Figure 1-3.

Atmospheric pressure limitations. See section A.7 for specifications.

Humidity limitations. See section A.7 for specifications.

Temperature limitations. See section A.7 for specifications.

Fragile.

Keep dry.

Keep away from direct sunlight.

This side up.

Stacking limitation.

The number shown (represented by “n”) indicates the maximum number of additional identical packages that may be stacked on top of a package containing this device, when this device is correctly packaged.

For the Puritan Bennett™ 560 ventilator, n = 2.

Lithium battery.

This symbol Indicates that the contents of the package contain lithium batteries.

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. See 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 Table 1-2 to locate the labels in Figures 1-1 through

1-4.

Table 1-2. Ventilator Labels and Markings

Labels (Identification and Instruction Information)

:Note:

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

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

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

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

Figure 1-4. Location of Labels—Bottom View

2Ventilator Overview

2.1Indications 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.

2.1.1 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

2.1.2Target Environments

The ventilator is suitable for use in institutional, home, and portable settings. It is not intended for use in Emergency Medical Service (EMS) such as an emergency transport.

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

2.1.3Target Operators

<WARNING:

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

The ventilator may be operated by the following caregivers:

•Respiratory therapists

•Doctors

•Nurses

•Homecare providers

•Patient and patient’s families

For more details on knowledge and skill requirements for operating the Puritan Bennett™ 560 ventilator, please consult your clinician.

It is the responsibility of the clinician or clinical educator to ensure that both the patient and the caregiver fully understand the topics necessary for operation of the ventilator.

2.2 Contraindications

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

Operational Use

2.3 Operational Use

The Puritan Bennett™ 560 ventilator uses a micro-turbine to provide ventilatory support to patients. Clinicians may use a variety of interfaces to connect patients to the ventilator for continuous or intermittent ventilatory support. Some examples include mouthpieces; nasal masks or full face masks; endotracheal tubes or tracheotomy tubes. User-selectable ventilation modes are:

•Assisted Controlled Volume (V A/C)

•Assisted Controlled Pressure (P A/C)

•Volume Synchronized Intermittent Mandatory Ventilation (V SIMV)

•Pressure Synchronized Intermittent Mandatory Ventilation (P SIMV)

•Continuous Positive Airway Pressure (CPAP)

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

2.3.1Safety 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, see Chapter 3, Alarms and Troubleshooting.

2.3.2 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.

2.3.3 Oxygen Enrichment

Oxygen may be supplied from an external, low pressure source, but the oxygen flow must be limited to 15 lpm (50 kPa, 500 mbar). The ventilator automatically compensates for the extra flow created by the external oxygen supply (see Chapter 4, Installation and Assembly.)

2.3.4 Breathing Circuit

The ventilator can be used with a singleor double-limb patient circuit. If exhaled volume monitoring is required (such as ventilator dependent patients), use the double-limb circuit for exhaled tidal volume monitoring. For more information, see section 4.4, Patient Circuit.

<WARNING:

Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett™ 560 ventilator.

2.4Device Classification

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

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

•Protection index of enclosure: IP32

•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, see Appendix A, Specifications.

Front Panel

2.5 Front Panel

Figure 2-1. Front Panel

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

2.6 Back Panel

Figure 2-2. Back Panel

Control Panel

2.7 Control Panel

Figure 2-3. Control Panel

2.8 Ventilation Menu

Figure 2-4. Ventilation Menu Display (on standby at left; during ventilation at right)

Alarm Menu

2.9 Alarm Menu

Figure 2-5. Alarm Menu (on standby at left; during ventilation at right)

2.10 Waveforms Menu

The display of waveforms (see Figure 2-6) is optional and can be selected using the Menu key.

The Waveform menu is only accessible when ventilation is active.

Figure 2-6. Waveforms Menu