540 Ventilator Clinicians Manual Rev B

Contents Preface... Preface - 1 1

Safety Information... 1 - 1 1.1 Definitions... 1 - 1 1.2 Warnings... 1 - 1 1.3 Symbols and Markings... 1 - 11 1.4 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 USB Memory Device Menu... 2 - 9 2.11 If Ventilator Failure Occurs... 2 - 9

3

Operating Parameters... 3 - 1 3.1 PSV Mode Parameters and Setting Ranges... 3 - 1 3.2 CPAP Mode Parameters and Setting Ranges... 3 - 6 3.3 P A/C Mode Parameters and Setting Ranges... 3 - 8 3.4 FiO2 For Various Oxygen and Ventilator Settings... 3 - 13

4

Monitored Parameters... 4 - 1 4.1 Digital Monitoring... 4 - 1 4.2 Bargraph Display... 4 - 4 4.3 Ventilation Report... 4 - 4

5

Alarms and Troubleshooting... 5 - 1 5.1 Alarm Level of Priority... 5 - 1 5.2 Alarm Display... 5 - 2 5.3 Alarm Log Menu... 5 - 3 5.4 Silencing the Audible Portion of Alarms... 5 - 4 5.5 Pausing/Resetting Alarms... 5 - 5 5.6 Re-activating Alarms... 5 - 6 5.7 Overview of Alarms... 5 - 7

Clinician’s Manual

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Contents

5.8

2

Troubleshooting... 5 - 14 5.8.1 Alarms... 5 - 14 5.8.2 Additional Troubleshooting... 5 - 21

6

Installation and Assembly... 6 - 1 6.1 Installing the Ventilator... 6 - 1 6.2 Connecting to External AC Power... 6 - 2 6.3 Connecting to an External DC Power Source... 6 - 4 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 - 11 6.7 Oxygen... 6 - 12 6.7.1 Administering Oxygen... 6 - 12 6.7.2 Connecting the Oxygen Supply... 6 - 13 6.8 Fitting the Ventilator into the Dual Bag... 6 - 15 6.9 Mounting the Ventilator on a Wheelchair... 6 - 16 6.10 Mounting the Ventilator on the Utility Cart... 6 - 17 6.11 Connecting the Nurse Call Cable... 6 - 18

7

Operating Procedures... 7 - 1 7.1 Turning on the Ventilator... 7 - 1 7.2 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 - 8 7.3 Preferences Menu Parameters... 7 - 8 7.3.1 Preferences Menu... 7 - 8 7.3.2 Backlight... 7 - 10 7.3.3 Contrast... 7 - 10 7.3.4 Alarm Volume... 7 - 11 7.3.5 Key Sound... 7 - 12 7.3.6 Intentional Vent Stop Alarm... 7 - 12 7.3.7 Apnea Alarm... 7 - 12 7.3.8 Disconnection Alarm... 7 - 13 7.3.9 Pediatric Circuit... 7 - 13 7.3.10 Ventilation Report... 7 - 14 7.4 Setting the Ventilation Mode... 7 - 14 7.4.1 Changing Modes While Ventilation is on Standby. 7 - 15 7.4.2 Changing Modes During Ventilation... 7 - 15 7.5 Setting Ventilation Parameters... 7 - 18 7.5.1 Links between Ventilation Parameters... 7 - 19 7.5.2 Links between Ventilation and Alarm Parameters . 7 - 19 7.6 Setting Alarm Parameters... 7 - 19 7.7 USB Menu Parameters... 7 - 21 7.7.1 USB Memory Device Specifications... 7 - 22 Clinician’s Manual

7.8 7.9 7.10 7.11 7.12

7.7.2 USB Menu... 7 - 22 7.7.3 Transfer Continuously... 7 - 22 7.7.4 Transfer Trends... 7 - 23 7.7.5 Erase Data from the USB Memory Device... 7 - 25 Locking the Control Panel... 7 - 26 Unlocking the Control Panel... 7 - 26 Starting Ventilation... 7 - 27 Stopping Ventilation... 7 - 28 Turning Off the Ventilator... 7 - 29

8

Internal Battery... 8 - 1 8.1 Battery Capacity... 8 - 1 8.2 Battery Operation... 8 - 2 8.3 Testing the Battery... 8 - 4 8.4 Recharging the Battery... 8 - 4 8.5 Storage... 8 - 5

9

Cleaning... 9 - 1 9.1 Cleaning the Ventilator... 9 - 1 9.2 Cleaning the Accessories... 9 - 2 9.3 Cleaning the Ventilator Between Patients... 9 - 2

10

Routine Maintenance... 10 - 1 10.1 Replacing the Air Inlet Filter... 10 - 1 10.2 Recommended Schedule of Maintenance... 10 - 2 10.3 Service Assistance... 10 - 3

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 - 5 B.7 Environmental... B - 7 B.8 USB... B - 7 B.9 Pneumatic... B - 8 B.10 Manufacturer’s Declaration... B - 9 B.11 Standards Compliance and IEC Classification... B - 13

C

Theory of Operation... C - 1 C.1 Architecture... C - 1 C.2 Operation... C - 1

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Contents

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D

Modes and Breath Types... D - 1 D.1 Modes of Ventilation... D - 1 D.1.1 Assist/Control (A/C) Mode... D - 1 D.1.2 CPAP Mode... D - 1 D.1.3 PSV Mode... D - 1 D.2 Breath Types... D - 1 D.2.1 Pressure Control Breaths in Assist/Control Mode. . . D - 1 D.2.2 Pressure Supported Breaths in PSV Mode... D - 2 D.2.3 CPAP... D - 3 D.3 Ventilation Modes and Apnea... D - 3 D.4 VT Target... D - 4

E

Operational Verification Checklist... E - 1

F

Alarms Tests... F - 1 F.1 Low Pressure Test... F - 1 F.2 Apnea Test... F - 2 F.3 Power Failure Test... F - 2 F.4 Occlusion Test... F - 2 F.5 Testing the Battery... F - 3 F.6 Involuntary Stop Test... F - 4

G

Unpacking and Preparation... G - 1

H

Parts and Accessories... H - 1

I

Glossary... I - 1

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Figures

Figure 1-1. Locations of Labels – Top-Front View... Figure 1-2. Location of Labels and Markings – Rear View... Figure 1-3. Location of Labels – Bottom View... Figure 2-1. Front Panel... Figure 2-2. Back Panel... Figure 2-3. Control Panel... Figure 2-4. Ventilation Menu Display... Figure 2-5. Alarm Menu... Figure 2-6. USB Memory Device Menu... Figure 3-1. Menus in PSV Mode with Exhalation Valve Configuration... Figure 3-2. Menus in PSV Mode with Leakage Configuration... Figure 3-3. Exhalation Trigger Sensitivity... Figure 3-4. Menus in CPAP Mode in Leakage Configuration... Figure 3-5. Menus in P A/C Mode with Exhalation Valve Configuration... Figure 3-6. Menus in P A/C Mode with Leakage Configuration... Figure 3-7. Fi02 for Oxygen and Ventilator Settings... Figure 4-1. Ventilation Menu: Pressure Leakage Configuration Modes (CPAP, PSV ST, P A/C) . . . Figure 4-2. Ventilation Menu: Pressure Valve Configuration Modes (PSV ST, P A/C)... Figure 4-3. Alarm Menu: Pressure Leakage Modes (CPAP, PSV ST, P A/C)... Figure 4-4. Alarm Menu: Pressure Valve Modes (PSV ST, P A/C)... Figure 4-5. Inspiratory Effort Detected Indicator... Figure 4-6. Bargraph Display... Figure 4-7. Ventilation Report... Figure 5-1. Alarm Displays... Figure 5-2. Accessing Alarm Log Menu... Figure 5-3. Displaying the Alarm Log Screen... Figure 5-4. Alarm Log Display when No Alarm Activated... Figure 5-5. Silencing the Audible Portion of Alarms... Figure 5-6. Manually Pausing Alarms... Figure 5-7. Reactivating Alarms... Figure 5-8. Alarm Log... Figure 6-1. The Power Cable Holder... Figure 6-2. Inserting the Power Cable Holder Into the Notch... Figure 6-3. Power Cable Connected to the Ventilator... Figure 6-4. Power Indicators... Figure 6-5. Connecting the Ventilator to an External DC Power Source... Figure 6-6. Connecting the DC Power Cable to the Ventilator... Figure 6-7. Single Limb Patient Circuit With Exhalation Valve... Figure 6-8. Close-up of Exhalation Valve Tube and Proximal Pressure Tube... Figure 6-9. Single Limb Patient Circuit Without Exhalation Valve... Figure 6-10. Air Inlet Filter... Figure 6-11. Bacteria Filter... Figure 6-12. Humidifier... Figure 6-13. Rear Panel Oxygen Connector... Figure 6-14. Connecting the Oxygen Supply System... Figure 6-15. Disconnecting the Oxygen Supply System... Figure 6-16. Using the Dual Bag... Figure 6-17. Mounting the Ventilator on the Utility Cart... Figure 6-18. Using the Utility Cart... Figure 6-19. Connecting the Nurse Call Cable... Clinician’s Manual

1–16 1–16 1–17 2–4 2–5 2–6 2–7 2–8 2–9 3–1 3–2 3–4 3–7 3–9 3–9 3–13 4–1 4–1 4–2 4–2 4–2 4–4 4–4 5–2 5–3 5–3 5–4 5–4 5–5 5–6 5–6 6–2 6–3 6–3 6–4 6–5 6–5 6–7 6–8 6–9 6–10 6–11 6–11 6–13 6–14 6–14 6–16 6–17 6–17 6–18 5

Figures

Figure 7-1. Turning on the Ventilator... Figure 7-2. Welcome Menu Screen... Figure 7-3. Ventilation Menu Parameters... Figure 7-4. Setup Menu... Figure 7-5. Absolute and Relative Pressure... Figure 7-6. E Sens Settings... Figure 7-7. Resetting Patient Hours to Zero (1)... Figure 7-8. Resetting Patient Hours to Zero (2)... Figure 7-9. Resetting Patient Hours to Zero (3)... Figure 7-10. Resetting Patient Hours to Zero (4)... Figure 7-11. Selecting the Preferences Menu... Figure 7-12. Changing Settings in the Preferences Menu... Figure 7-13. Modifying the Parameters... Figure 7-14. Increasing the Contrast... Figure 7-15. Decreasing the Contrast... Figure 7-16. Increasing the Alarm Volume... Figure 7-17. Decreasing the Alarm Volume... Figure 7-18. Setting the Apnea Alarm... Figure 7-19. Accessing the Ventilation Report... Figure 7-20. Changing Ventilation Modes While on Standby... Figure 7-21. Changing Ventilation Modes During Ventilation... Figure 7-22. Displaying Active and Inactive Modes... Figure 7-23. Changing the Settings of the New Mode... Figure 7-24. Changing Ventilation Modes and Parameters... Figure 7-25. Modifying a Ventilation Parameter... Figure 7-26. Setting Links Between Ventilation Parameters... Figure 7-27. Modifying Alarm Parameters – Min Value... Figure 7-28. Modifying Alarm Parameters – Max Value... Figure 7-29. Selecting the USB Menu... Figure 7-30. Selecting Transfer Continuously... Figure 7-31. Selecting Transfer Trends... Figure 7-32. Erasing Data from the USB Memory Device... Figure 7-33. Enabling the Locking Key... Figure 7-34. Prompt to Start Ventilation... Figure 7-35. Starting Ventilation... Figure 7-36. Stopping Ventilation (1)... Figure 7-37. Stopping Ventilation (2)... Figure 8-1. Internal Battery Indicator... Figure 8-2. Battery Reserve Capacity as a Percentage... Figure 8-3. Battery Reserve Capacity in Hours and Minutes... Figure 8-4. Power Indicators When Charging the Battery... Figure 10-1. Replacing the Air Inlet Filter... Figure C-1. Gas Delivery System... Figure D-1. Flow Patterns in P A/C Mode... Figure D-2. Controlled Machine Breaths in P A/C Mode... Figure D-3. Pressure Supported Breaths in PSV Mode... Figure D-4. Flow Patterns in CPAP Mode... Figure D-5. Target Volume in Pressure Modes... Figure F-1. Blocking the Patient End of a Single Limb Circuit... Figure G-1. Puritan Bennett™ 520 Ventilator... Figure G-2. Dual Bag...

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7–2 7–2 7–3 7–3 7–6 7–6 7–7 7–7 7–7 7–8 7–9 7–9 7–9 7–11 7–11 7–11 7–11 7–13 7–14 7–15 7–16 7–16 7–17 7–17 7–18 7–19 7–20 7–20 7–22 7–23 7–24 7–25 7–26 7–27 7–28 7–28 7–29 8–2 8–3 8–3 8–4 10–2 C–2 D–2 D–2 D–3 D–3 D–4 F–3 G–2 G–2

Clinician’s Manual

Tables Table 1-1. Ventilator Symbols... Table 1-2. Ventilator Labels and Markings... Table 3-1. Ventilation Parameters in PSV Menu... Table 3-2. Alarm Parameters in PSV Mode... Table 3-3. Ventilation Parameters in CPAP Menu... Table 3-4. Alarm Parameters in CPAP Mode... Table 3-5. Ventilation Parameters in P A/C Mode Menu... Table 3-6. Alarm Parameters in P A/C Mode... Table 4-1. Displayed Monitored Parameters... Table 5-1. Overview of Alarms... Table 5-2. Alarms and Corrective Actions... Table 5-3. Additional Troubleshooting and Corrective Actions... Table 7-1. Languages... Table 7-2. USB Memory Device Specifications... Table 7-3. Trends Data Transfer Time from Ventilator to USB Memory Device... Table 8-1. Internal Battery Reserve Capacity... Table 9-1. Approved Cleaning Solutions for Exterior Ventilator Surfaces... Table 10-1. Consumables and Replacement Intervals... Table A-1. Patient/Caregiver Checklist... Table B-1. Physical Description (Excluding Accessories)... Table B-2. AC Electrical Supply... Table B-3. Internal Lithium Ion Battery... Table B-4. Remote Alarm... Table B-5. Power Indicators... Table B-6. Alarm Indicators... Table B-7. Audio Alarms... Table B-8. Performance Parameter Specifications and Tolerances... Table B-9. Monitored Parameter Specifications and Tolerances... Table B-10. Ventilator Range, Resolution, and Accuracy... Table B-11. Environmental Conditions for Storage or Transport... Table B-12. Environmental Conditions for Operation... Table B-13. USB Memory Device Specifications... Table B-14. Data Transfer Characteristics... Table B-15. Airway Resistances... Table B-16. Air Inlet Resistance (Filter)... Table B-17. Oxygen Inlet Specifications... Table B-18. Performance Specifications... Table B-19. Electromagnetic Emissions... Table B-20. Electromagnetic Immunity... Table B-21. Electromagnetic Immunity – Conducted and Radiated RF... Table B-22. Recommended Separation Distances... Table B-23. Compliant Cables and Accessories... Table D-1. Volume target measurements in pressure modes... Table E-1. Operational Verification Checklist... Table H-1. List of Consumables and Accessories... Table H-2. List of Circuits...

Clinician’s Manual

1–11 1–14 3–2 3–2 3–7 3–7 3–9 3–10 4–3 5–7 5–14 5–21 7–5 7–22 7–24 8–1 9–1 10–2 A–1 B–1 B–1 B–1 B–2 B–3 B–3 B–3 B–3 B–3 B–5 B–7 B–7 B–7 B–8 B–8 B–8 B–8 B–8 B–9 B–10 B–11 B–12 B–13 D–4 E–1 H–1 H–2

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Tables

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Clinician’s Manual

Purpose of This Manual

Preface Purpose of This Manual This manual contains important information regarding the safe operation of your Puritan Bennett™ 520 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™ 520 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.respiratorysolutions.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.

Clinician’s Manual

Preface-1

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 Hungary 1095 Budapest Mariassy u. 7 Magyarorszag Hungary Tel + 36 1880 7975 Fax + 36 1777 4932

Preface-2

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 Ireland Commercial Ltd Block G, Ground Floor, Cherrywood Technology Park, Loughlinstown County Dublin Ireland Tel +353 1 4381613

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 Israel 5 Shacham St. North Industrial Park Caesarea 38900 Israel Tel +97 246 277 388 Fax+97 266 277 688

Clinician’s Manual

Technical Support

Technical Service Contacts: 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 России 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 and Ireland Unit 2, Talisman Business Park London Road, Bicester OX26 6HR, United Kingdom Tel +44(0)1869 328092 Fax +44(0)1869 327585

Clinician’s Manual

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 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 or 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

Asia: Tyco Healthcare Pte Ltd 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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Clinician’s Manual

Definitions

1 Safety Information 1.1

Definitions This manual uses three indicators to highlight critical information: Warning, Caution, and Note. They are defined as follows:

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

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™ 520 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 Fire Hazard Warnings

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

• Never expose any batteries to direct flame. • 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 reduce the oxygen concentration level.

Warnings about Reducing Infection

• 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.

• Single Use accessories should not be reused. • The air inlet filter is for use on a single patient and is not reusable; do not attempt to wash, clean, or reuse it.

Clinician’s Manual

1-1

Safety Information

Warnings before Using Equipment

• The ventilator must be used only under the responsibility and on the prescription of a doctor. • The ventilator is not intended to be used for patients without breathing autonomy or who are ventilator dependent.

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

• 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 Appendix F, “Alarms Tests”.

• If the ventilator fails the alarm tests or if you cannot complete the tests, refer to section 5.8, “Troubleshooting” or call your equipment supplier or 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.

• 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, properly connected to the ventilator, and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies.

• This ventilator offers a choice of breath delivery modes and types. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode and/or breath type to use for that patient. This selection should be based on the clinician’s clinical judgment, considering the condition and needs of the individual patient, as such condition and needs change from time to time, and considering the benefits, limitations and operating characteristics of each mode and/or breath type.

• Patients on home care ventilation equipment should be appropriately monitored by clinicians, caregivers and suitable monitoring equipment, as advised by the patient’s clinician. The Puritan Bennett™ 520 Ventilator is not intended to be a comprehensive monitoring device and does not activate alarms for all types of dangerous conditions for patients.

Warnings regarding Environment of Use

• 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 patient circuit 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.

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Clinician’s Manual

Warnings

• 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.

• 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.

• 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, properly connected to the ventilator, and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies.

• 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.

• Due to typical voltage fluctuations that occur during normal power wheelchair use, the wheelchair mains battery should never be used to power the Puritan Bennett™ 520 Ventilator. The ventilator should always be connected to an independent power source (e.g. AC power, extra batteries, or DC power source).

• 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.

• Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. See 7.3.4, “Alarm Volume”. The audible alarm vents located at the front of the device should never be obstructed.

Warnings Regarding Electromagnetic Interference

• The Puritan Bennett™ 520 ventilator requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix B, “Specifications.” In particular, the use of nearby mobile and portable communications equipment using radio frequencies, such as mobile telephones or other systems exceeding the levels set in the IEC 60601-1-2 standard, may affect its operation. Refer to section B.10, “Manufacturer’s Declaration”.

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

Warnings regarding Settings

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

• The Puritan Bennett™ 520 Ventilator offers a variety of breath delivery modes. Throughout the patient’s treatment, the clinician should carefully select the ventilation mode or modes to use for that patient. This selection should be based on the clinician's clinical judgment, considering the condition and needs of the individual patient, as such condition and needs change from time to time, and considering the benefits, limitations and operating characteristics of each mode.

• The CPAP mode does not provide a set respiratory rate. Do not use this mode if it is not appropriate for the patient’s condition.

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Safety Information

• Alarm volume should be adjusted with respect to the ventilator’s operating environment and so that the patient's caretakers can hear the alarms. See 7.3.4, “Alarm Volume”.

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

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

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

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

• The setting of the Min PIP alarm must be adjusted for the patient, but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly. Perform the Low Pressure Test (refer to section F.1, “Low Pressure Test”) to ensure the Min PIP alarm is properly set.

• If APNEA TIME is set to a value higher than 60/Control R then the APNEA alarm will not activate. • The Apnea Alarm should be set to YES if an audible alarm sound is desired when apnea events occur. • Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction. • Ensure the I Time setting is compatible with the physiological requirements of the patient. • Adjustable alarms should not be systematically cancelled; instead, they should be adjusted according to the needs and condition of the patient.

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

Warnings Applicable during Use of Equipment

• 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”. • The ventilator is not intended to be used for patients without breathing autonomy or who are ventilator dependent.

• Be aware this manual describes how to respond to the 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. Supplementary observation, appropriate for the patient's condition, is also recommended.

• Patients 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 alarm condition or experiences a problem.

• 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.

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

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Warnings

• 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.

• Even though the Puritan Bennett™ 520 Ventilator meets current safety standards, and although the internal Lithium-ion battery of the device is considered to be Dangerous Goods for transport in commerce, this devices lithium battery is below the 100Wh threshold and is therefore excepted from being a Class 9 – Miscellaneous - Dangerous Goods (DG). As such, the Puritan Bennett™ 520 Ventilator and/or the associated Lithium-ion battery are subject to some 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™ 520 Ventilator is permitted as checked-in or carry-on baggage. Spare batteries may be taken on board as carry-on luggage only. 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”.

• 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.

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

• 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.

Warnings regarding Electrical Power

• 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.

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

• 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.

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

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Safety Information

• Due to typical voltage fluctuations that occur during normal power wheelchair use, the wheelchair mains battery should never be used to power the Puritan Bennett™ 520 Ventilator. The ventilator should always be connected to an independent power source. (e.g. AC power, extra batteries, or DC power source)

• 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, or more, prior to its first use.

• Periodic recharging is important to help maximise 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 section 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. • 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.

• 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.

• 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.

• To connect the ventilator to an external power source, first connect the desired power cable to the ventilator. Then connect the power cable to the external power source.

• To disconnect the ventilator from an external power source, first disconnect the power cable from the external power source and then, the ventilator.

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

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Warnings

Warnings regarding Oxygen

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

• Strictly follow the instructions provided in section 6.7.2 , “Connecting the Oxygen Supply”, which include the use of a special oxygen connector.

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

• If using oxygen with the Puritan Bennett™ 520 Ventilator, Covidien recommends using an oxygen analyser with minimum and maximum concentration alarms. Always measure the delivered oxygen with a calibrated oxygen analyser that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient.

• The Puritan Bennett™ 520 Ventilator is designed to deliver a percentage of oxygen equal to or lower than 50%. Do not exceed this value as this may cause the ventilator to malfunction and put the patient at risk.

• Ensure that the oxygen supply pressure to the machine never exceeds 7 psi (50 kPa) or a flow of 15 lpm. Refer to Table B-8 on page B-3 for sensitivity tolerances.

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

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

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

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

• To ensure stability, when the Puritan Bennett™ 520 Ventilator is mounted on a cart, the weight of the oxygen bottle should not exceed 14 kg (30 lbs).

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

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

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

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

Warnings regarding Hoses and Accessories

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

• 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.

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