560 Clinicians Manual Rev B March 2012

Contents Preface...

xi

1 Safety Information... 1.1 1.2 1.3 1.4

1–1 Definitions... 1–1 Warnings... 1–1 Symbols and Markings... 1–10 Labels / Identification and Instruction Information... 1–14

2 Ventilator Overview...

2–1 2.1 Indications for Use... 2–1 2.2 Contraindications... 2–2 2.3 Operational Use... 2–2 2.4 Device Classification... 2–3 2.5 Front Panel... 2–4 2.6 Back Panel... 2–5 2.7 Control Panel... 2–6 2.8 Ventilation Menu... 2–7 2.9 Alarm Menu... 2–8 2.10 Waveforms Menu... 2–9 2.11 USB Memory Device Menu... 2–10 2.12 If Ventilator Failure Occurs... 2–10

3 Operating Parameters... 3.1 3.2 3.3 3.4 3.5 3.6 3.7

3–1 PSV Mode Parameters and Setting Ranges... 3–1 CPAP Mode Parameters and Setting Ranges... 3–7 P A/C Mode Parameters and Setting Ranges... 3–9 V A/C Mode Parameters and Setting Ranges... 3–14 P SIMV Mode Parameters and Setting Ranges... 3–18 V SIMV Mode Parameters and Setting Ranges... 3–23 FIO2 For Various Oxygen and Ventilator Settings... 3–29

4 Monitored Parameters... 4.1 4.2 4.3 4.4

Digital Monitoring... Bargraph Display... Waveform Display... Ventilation Report...

4–1 4–1 4–6 4–6 4–7

5 Alarms and Troubleshooting... 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8

Clinician’s Manual

5–1 Alarm Level of Priority... 5–1 Alarm Display... 5–2 Alarm Logs Menu... 5–3 Silencing the Audible Portion of Alarms... 5–4 Pausing/Resetting Alarms... 5–5 Re-activating Alarms... 5–6 Overview of Alarms... 5–7 Troubleshooting... 5–13 5.8.1 Alarms... 5–13 5.8.2 Additional Troubleshooting... 5–24 i

Contents

6 Installation and Assembly...

6–1 Installing the Ventilator... 6–1 Connecting to External AC Power... 6–2 Connecting to an External DC Power Source... 6–4 Patient Circuit... 6–6 6.4.1 Choosing the Patient Circuit Type... 6–6 6.4.2 Installing the Patient Circuit... 6–7 6.5 Filters... 6–10 6.6 Humidifier... 6–12 6.7 Exhalation Block... 6–13 6.8 Oxygen... 6–14 6.8.1 Administering Oxygen... 6–14 6.8.2 Connecting the Oxygen Supply... 6–14 6.8.3 Connecting the FIO2 sensor... 6–17 6.9 Mounting the Ventilator on a Wheelchair... 6–18 6.10 Mounting the Ventilator on the Utility Cart... 6–19 6.11 Connecting the Nurse Call Cable... 6–20 6.1 6.2 6.3 6.4

7 Operating Procedures... 7.1 7.2

7.3

7.4

7.5

7.6 7.7

7.8 7.9 ii

7–1 Turning on the Ventilator... 7–1 Setup Menu Parameters... 7–3 7.2.1 Accessing Setup Configuration... 7–3 7.2.2 Changing the Setup Menu Parameters... 7–4 7.2.3 Exiting the Setup Screen... 7–9 Preferences Menu Parameters... 7–10 7.3.1 Preferences Menu... 7–10 7.3.2 Backlight... 7–11 7.3.3 Contrast... 7–12 7.3.4 Alarm Volume... 7–13 7.3.5 Key Sound... 7–13 7.3.6 Apnea Alarm... 7–14 7.3.7 Disconnection Alarm... 7–15 7.3.8 Waveforms Display... 7–15 7.3.9 Pediatric Circuit... 7–15 7.3.10 Ventilation Report... 7–16 Setting the Ventilation Mode... 7–16 7.4.1 Changing Modes While Ventilation is on Standby... 7–17 7.4.2 Changing Modes During Ventilation... 7–17 Setting Ventilation Parameters... 7–20 7.5.1 Links between Ventilation Parameters... 7–21 7.5.2 Links between Ventilation and Alarm Parameters... 7–21 Setting Alarm Parameters... 7–22 USB Menu Parameters... 7–24 7.7.1 USB Memory Device Specifications... 7–24 7.7.2 USB Menu... 7–24 7.7.3 Transfer Continuously... 7–25 7.7.4 Transfer Trends... 7–26 7.7.5 Erase Data from the USB Memory Device... 7–27 Locking the Control Panel... 7–28 Unlocking the Control Panel... 7–29 Clinician’s Manual

Contents

7.10 Starting Ventilation... 7.11 Stopping Ventilation... 7.12 Turning Off the Ventilator...

7–29 7–30 7–31

8 Internal Battery...

8–1 8–1 8–2 8–4 8–4 8–5

8.1 8.2 8.3 8.4 8.5

Battery Capacity... Battery Operation... Testing the Battery... Recharging the Battery... Storage...

9 Cleaning... 9.1 9.2 9.3

Cleaning the Ventilator... Cleaning the Accessories... Cleaning the Exhalation Block...

10 Routine Maintenance... 10.1 Calibrating the Exhalation Flow Sensor... 10.2 Calibrating the FIO2 sensor... 10.3 Replacing the Air Inlet Filter... 10.4 Recommended Schedule of Maintenance... 10.5 Service Assistance...

9–1 9–1 9–2 9–2 10–1 10–1 10–4 10–6 10–7 10–8

A Patient/Caregiver Checklist... A–1 B Specifications...

B–1 B.1 Physical... B–1 B.2 Electrical... B–1 B.3 Indicators and Alarms... B–3 B.4 Performance... B–3 B.4.1 Specifications... B–3 B.5 Monitored Parameters... B–3 B.6 Range, Resolution, and Accuracy... 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... D.1.1 Assist/Control (A/C) Modes... D.1.2 SIMV Modes... D.1.3 CPAP Mode... D.1.4 PSV Mode... D.2 Breath Types...

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D–1 D–1 D–1 D–1 D–1 D–2

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Contents

D.2.1 Volume Breaths in Assist/Control Mode... D.2.2 Pressure Control Breaths in Assist/Control Mode... D.2.3 Volume Breaths in V SIMV Mode... D.2.4 Pressure Supported Breaths in SIMV and PSV Modes... D.2.5 CPAP... D.3 Ventilation Modes and Apnea...

D–2 D–3 D–4 D–5 D–6 D–6

E Operational Verification Checklist...

E–1

F

Low Pressure Test... Apnea Test... Power Failure Test... Occlusion Test... High Pressure Test... Testing the Battery... Involuntary Stop Test...

F–1 F–1 F–2 F–2 F–2 F–3 F–4 F–4

G Unpacking and Preparation...

G–1

H Parts and Accessories...

H–1

Alarms Tests... F.1 F.2 F.3 F.4 F.5 F.6 F.7

I

Glossary... I–1 Index...

iv

Index–1

Clinician’s Manual

Figures Figure 1-1. Figure 1-2. Figure 1-3. Figure 1-4. Figure 2-1. Figure 2-2. Figure 2-3. Figure 2-4. Figure 2-5. Figure 2-6. Figure 2-7. Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 3-8. Figure 3-9. Figure 3-10. Figure 3-11. Figure 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7. Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11. Figure 4-12. Figure 4-13. Figure 4-14. Figure 4-15. Figure 5-1. Figure 5-2. Figure 5-3.

Clinician’s Manual

Locations of Labels – Top-Front View... 1–15 Locations of Labels – Front-Left View... 1–16 Location of Labels and Markings – Rear View... 1–16 Location of Labels – Bottom View... 1–17 Front Panel... 2–4 Back Panel... 2–5 Control Panel... 2–6 Ventilation Menu Display... 2–7 Alarm Menu... 2–8 Waveforms Menu... 2–9 USB Memory Device Menu... 2–10 Menus in PSV Mode with exhalation valve configuration... 3–1 Menus in PSV Mode with leakage configuration... 3–1 Exhalation Trigger Sensitivity... 3–4 Menus in CPAP Mode in leakage configuration... 3–7 Menus in P A/C Mode with exhalation valve configuration... 3–9 Menus in P A/C Mode with leakage configuration... 3–9 Menus in the V A/C Mode... 3–14 Menus in P SIMV Ventilation Mode... 3–18 Exhalation trigger sensitivity... 3–21 Menus in V SIMV Ventilation Mode... 3–23 Exhalation trigger sensitivity... 3–27 Ventilation Menu: Pressure Leakage Configuration Modes (CPAP, PSV S, PSV ST, PCV, P A/C)... 4–1 Ventilation Menu: Pressure Valve Configuration Modes (PSV S, PSV ST, PCV, P A/C) 4–1 Ventilation Menu: Volume Mode (CV, V A/C, SIMV)... 4–2 Alarm Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV, P A/C)... 4–2 Alarm Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C)... 4–2 Alarm Menu: Volume Modes (CV, V A/C, SIMV)... 4–2 Waveform Menu: Pressure Leakage Modes (CPAP, PSV S, PSV ST, PCV, P A/C)... 4–3 Waveform Menu: Pressure Valve Modes (PSV S, PSV ST, PCV, P A/C) . 4–3 Waveform Menu: Volume Mode (CV, V A/C, SIMV)... 4–3 Monitored Parameter Inserts... 4–3 Display Showing Unavailable Parameter Values... 4–4 Inspiratory Effort Detected Indicator... 4–4 Bargraph Display... 4–6 Waveform Screen... 4–6 Ventilation Report... 4–7 Alarm Displays... 5–2 Accessing Alarm Logs Menu... 5–3 Displaying the Alarm Logs Screen... 5–3

v

Figures

Figure 5-4. Figure 5-5. Figure 5-6. Figure 5-7. Figure 5-8. Figure 6-1. Figure 6-2. Figure 6-3. Figure 6-4. Figure 6-5. Figure 6-6. Figure 6-7. Figure 6-8. Figure 6-9. Figure 6-10. Figure 6-11. Figure 6-12. Figure 6-13. Figure 6-14. Figure 6-15. Figure 6-16. Figure 6-17. Figure 6-18. Figure 6-19. Figure 6-20. Figure 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure 7-8. Figure 7-9. Figure 7-10. Figure 7-11. Figure 7-12. Figure 7-13. Figure 7-14. Figure 7-15. Figure 7-16. Figure 7-17. Figure 7-18. Figure 7-19. Figure 7-20. Figure 7-21.

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Alarm Logs Display when No Alarm Activated... 5–3 Silencing the Audible Portion of Alarms... 5–4 Manually Pausing Alarms... 5–5 Reactivating Alarms... 5–6 Alarm Logs... 5–6 The Power Cable Holder... 6–2 Inserting the Power Cable Holder Into the Notch... 6–3 Power Cable Connected to the Ventilator... 6–3 Power Indicators... 6–4 Connecting the Ventilator to an External DC Power Source... 6–5 Connecting the DC Power Cable to the Ventilator... 6–5 Single Limb Patient Circuit With Exhalation Valve... 6–7 Double Limb Patient Circuit... 6–8 Close-up of Exhalation Valve Tube and Proximal Pressure Tube... 6–9 Single limb Patient Circuit Without Exhalation Valve... 6–9 Air Inlet Filter... 6–11 Bacteria Filter... 6–11 Humidifier... 6–12 Removing the Exhalation Block... 6–13 Rear Panel Oxygen Connector... 6–15 Connecting the Oxygen Supply System... 6–15 Disconnecting the Oxygen Supply System... 6–16 Connecting the FIO2 sensor... 6–17 Using the Dual Bag Accessory... 6–18 Connecting the Nurse Call Cable... 6–20 Turning on the Ventilator... 7–2 Welcome Menu Screen... 7–2 Ventilation Menu Parameters... 7–3 Setup Menu... 7–3 Absolute and Relative Pressure... 7–6 E Sens Settings... 7–7 Resetting Patient Hours to Zero (1)... 7–8 Resetting Patient Hours to Zero (2)... 7–8 Resetting Patient Hours to Zero (3)... 7–9 Resetting Patient Hours to Zero (4)... 7–9 Selecting the Preferences Menu... 7–10 Changing Settings in the Preferences Menu... 7–10 Setting the Apnea Alarm... 7–14 Accessing the Ventilation Report... 7–16 Changing Ventilation Modes While on Standby... 7–17 Changing Ventilation Modes During Ventilation (1)... 7–17 Changing Ventilation Modes During Ventilation (2)... 7–18 Changing Ventilation Modes During Ventilation (3)... 7–18 Changing Ventilation Modes During Ventilation (4)... 7–19 Modifying a Ventilation Parameter... 7–20 Setting Links Between Ventilation Parameters... 7–21

Clinician’s Manual

Figures

Figure 7-22. Figure 7-23. Figure 7-24. Figure 7-25. Figure 7-26. Figure 7-27. Figure 7-28. Figure 7-29. Figure 7-30. Figure 7-31. Figure 7-32. Figure 8-1. Figure 8-2. Figure 8-3. Figure 8-4. Figure 10-1. Figure 10-2. Figure 10-3. Figure 10-4. Figure 10-5. Figure 10-6. Figure 10-7. Figure 10-8. Figure 10-9. Figure C-1. Figure F-1. Figure G-1. Figure G-2.

Clinician’s Manual

Modifying Alarm Parameters – Min Value... 7–22 Modifying Alarm Parameters – Max Value... 7–23 Selecting the USB Menu... 7–24 Selecting Transfer Continuously... 7–25 Selecting Transfer Trends... 7–26 Erasing Data from the USB Memory Device... 7–27 Installing the Locking Key... 7–28 Prompt to Start Ventilation... 7–29 Starting Ventilation... 7–30 Stopping Ventilation (1)... 7–30 Stopping Ventilation (2)... 7–31 Internal Battery Indicator... 8–3 Battery Reserve Capacity as a Percentage... 8–3 Battery Reserve Capacity in Hours and Minutes... 8–3 Power Indicators When Charging the Battery... 8–5 Blocking the Patient Wye (Double-Limb Circuit Shown)... 10–1 Calibrating the Exhalation Flow Sensor (1)... 10–2 Calibrating the Exhalation Flow Sensor (2)... 10–2 Calibrating the Exhalation Flow Sensor (3)... 10–2 Calibrating the FIO2 sensor (1)... 10–4 Calibrating the FIO2 Sensor (2)... 10–4 Calibrating the FIO2 Sensor (3)... 10–5 Calibrating the FIO2 Sensor (4)... 10–5 Replacing the Air Inlet filter... 10–6 Gas Delivery System... C–2 Blocking the Patient End of a Single Limb Circuit... F–3 Puritan Bennett™ 560 Ventilator... G–2 Dual Bag... G–2

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Tables Table 1-1. Table 1-2. Table 3-1. Table 3-2. Table 3-3. Table 3-4. Table 3-5. Table 3-6. Table 3-7. Table 3-8. Table 3-9. Table 3-10. Table 3-11. Table 3-12. Table 4-1. Table 5-1. Table 5-2. Table 5-3. Table 7-1. Table 7-2. Table 7-3. Table 8-1. Table 9-1. Table 10-1. Table A-1. Table B-1. Table B-2. Table B-3. Table B-4. Table B-5. Table B-6. Table B-7. Table B-8. Table B-9. Table B-10. Table B-11. Table B-12. Table B-13. Table B-14. Table B-15. Table B-16. Table B-17. Table B-18.

Clinician’s Manual

Ventilator Symbols... 1–10 Ventilator Labels and Markings... 1–14 Ventilation Parameters in PSV Menu... 3–2 Alarm Parameters in PSV Mode... 3–2 Ventilation Parameters in CPAP Menu... 3–7 Alarm Parameters in CPAP Mode... 3–7 Ventilation Parameters in P A/C Mode Menu... 3–10 Alarm Parameters in P A/C Mode... 3–10 Ventilation Parameters in V A/C Ventilation Mode... 3–14 V A/C Mode Alarm Parameters... 3–14 Ventilation Parameters in P SIMV Ventilation Mode... 3–18 Alarm Parameters in P SIMV Ventilation Mode... 3–19 Ventilation Parameters in V SIMV Mode... 3–23 Alarm Parameters in the V SIMV Mode Menu... 3–24 Displayed Monitored Parameters... 4–4 Overview of Alarms... 5–7 Alarms and Corrective Actions... 5–14 Additional Troubleshooting and Corrective Actions... 5–24 Languages... 7–5 USB Memory Device Specifications... 7–24 Time taken to transfer trends data from the ventilator to a USB memory device... 7–27 Internal Battery Reserve Capacity... 8–2 Approved Cleaning Solutions for Exterior Ventilator Surfaces... 9–2 Consumables and Replacement Intervals... 10–7 Patient/Caregiver Checklist... A–1 Physical Description (Excluding Accessories)... B–1 AC Electrical Supply... B–1 Internal Lithium Ion Battery... B–2 Remote Alarm... B–2 Power Indicators... B–3 Alarm Indicators... B–3 Audio Alarms... B–3 Performance Parameter Specifications and Tolerances... B–3 Monitored Parameter Tolerances... B–3 Ventilator Range, Resolution, and Accuracy... B–4 Environmental Conditions for Storage or Transport... B–8 Environmental Conditions for Operation... B–8 USB Memory Device Specifications... B–8 Data Transfer Characteristics... B–8 Airway Resistances... B–9 Patient Circuit Resistances... B–9 Air Inlet Resistance (Filter)... B–9 Oxygen Inlet Specifications... B–9

ix

Tables

Table B-19. Table B-20. Table B-21. Table B-22. Table B-23. Table B-24. Table E-1. Table H-1. Table H-2.

x

Performance Specifications... B–9 Electromagnetic Emissions... B–10 Electromagnetic Immunity... B–11 Electromagnetic Immunity – Conducted and Radiated RF... B–12 Recommended Separation Distances... B–13 Compliant Cables and Accessories... B–14 Operational Verification Checklist... E–1 List of Consumables and Accessories... H–1 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 SolvITSM 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

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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

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

Clinician’s Manual

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]

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1

1.1

Safety Information

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.

Warning 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.

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.

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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.

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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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