520 Service Manual Rev G

Preface About This Manual This manual provides information needed to service the Puritan Bennett™ 520 Ventilator. This manual is intended for use by factory-trained biomedical engineering technicians or personnel with equivalent experience and training in servicing this type of equipment. It is recommended that the user complete the Puritan Bennett™ 520 Ventilator training class. Note: This manual is written assuming English (US) language is selected in ventilator SETUP (Section 2.12). Ventilator messages will be different depending upon the language selected. While this manual covers the ventilator configurations currently supported by Covidien, it may not be all-inclusive and may not be applicable to your ventilator. You should ensure you have the most current applicable version of this manual; if in doubt, contact Puritan Bennett LLC or visit the Covidien product manual web page at: http://www.covidien.com/rms/sales-support/product-manuals. Contact your local representative for questions regarding the applicability of the 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 following symbol’s meaning:

.

Electromagnetic Susceptibility The Puritan Bennett™ 520 Ventilator complies with the requirements of IEC 60601-1-2:2007 (EMC Collateral Standard), including the E-field susceptibility requirements at a level of 10 volts per meter at frequencies up to 1 GHz, and 10 volts per meter at frequencies between 1 GHz and 2.5 GHz, and the ESD requirements of this standard. However, even at this level of device immunity, certain transmitting devices (cellular phones, walkie-talkies, cordless phones, paging transmitters, etc.) emit radio frequencies that could interrupt ventilator operation if located in a range too close to the ventilator. It is difficult to determine when the field strength of these devices becomes excessive. Practitioners should be aware that radio frequency emissions are additive, and that the ventilator must be located a sufficient distance from transmitting devices to avoid interruption. Do not operate or store the ventilator in the presence of strong electromagnetic fields such as a magnetic resonance imaging (MRI) environment. Chapter 4 describes possible ventilator alarms and what to do if they occur. Contact an authorized service representative or you local durable medical equipment (DME) representative in case of interrupted ventilator operation and before relocating any life support equipment.

Service Manual

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Preface

WARNING Accessory equipment connected to the power receptacle, analog, and digital interfaces must be certified according to IEC 60601-1. Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the power receptacle, signal input part, or signal output part of the Puritan Bennett™ 520 Ventilator configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult Puritan Bennett Technical Support at 1.800.255.6774 or your local representative.

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.

Customer Assistance For online technical support, visit the SolvITSM Center Knowledge Base by clicking the link at www.medtronic.com/covidien/support/solvitcenter-knowledge-base/. Here, you will find answers to frequently asked questions about the Puritan Bennett™ 520 Ventilator, and other Puritan Bennett products 24 hours a day, 7 days a week. For troubleshooting help or to obtain service for your ventilator, call your local Puritan Bennett Technical Support center. If you require further assistance, contact your local Puritan Bennett representative.

Year of Manufacture The year of manufacture for ventilators is indicated on the bottom of the ventilator as shown here.

2007

Manufacturer The manufacturer and authorized representative are shown below|.

Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien lreland Limited, IDA Business & Technology Park, Tullamore.

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Service Manual

Service Centers

Service Centers The following table provides the addresses and phone numbers for the Covidien International Service Centers.

Table 1-1. Covidien International Service Centers Covidien Argentina

Covidien Asia

Covidien Australia

Vedia 3616

Singapore Regional Service Centre

52A Huntingwood Drive

15 Pioneer Hub, #06-04

Europaring F09402

Buenos Aires, Argentina

Covidien Austria GmbH Campus21

Tel: 5411 4863 5300

Singapore 627753

Huntingwood, NSW 2148

Fax: 5411 4863 4142

Tel: 65 6578 5288

Australia

A-2345 Österreich

Fax: 65 6515 5260

Tel: +61 1800 350702

Tel: +43 1 20609 1143

Fax: +61 2967 18118

Fax: +43 1 20609 2457

Covidien Brazil

Covidien Canada

Covidien Chile

19600 Clark Graham

Lo Boza 107 Pudahuel

2800 Mechelen

Praça Agrícola La Paz Tristante, 121 Osasco – São Paulo / CEP 06276-035

Belgium

São Paulo, SP

Tel: +32 220 08260 Fax: +32 270 06690

Covidien Belgium BVBA/SPRL. Generaal De Wittelaan 9/5

Baie d'Urfe, QC, H9X 3R8

Brunn am Gebrige

Santiago

Canada

Chile

Brasil

Tel:1 877 664 8926 (option 2)

Tel: 562 2739 3000

Tel: +55 11 2187 6543

Fax: 1 514 695 7534

Fax: 562 783 3149

Fax: 5511 2187-6380 Covidien China

Covidien Colombia

Covidien Costa Rica

Covidien ECE s.r.o.

1st Floor, Covidien Plaza, Building 14

Edificio Prados de la Morea

Global Park, Parkway 50

organizační složka

No. 99 Tian Zhou Rd

Carretera Central Del Norte

La Auroa de Heredia 40104

(Cra 7a)Kilometro 18,

Costa Rica

Tel: +420 241 095 735

Chia-Cundinamarca

Tel: 506 2293 4854

Fax: +420 239 016 856

Bogota, Colombia

Fax: 506 2239 9108

CAOHEJING High Tech Park Xu Hui District Shanghai 200233 P.R. China Tel: +86 400821-6699

Prosek, Prosecká 852/66 190 00 Praha 9

Tel: 571 668 3777

Fax: +86 2154 4511 18

Fax: 571 668 3777 ext. 181

Covidien Danmark A/S

Covidien Deutschland GmbH

Covidien ECE s.r.o.

Covidien Finland Oy

Galvaniho 7 / A

Rahtitie 3

Langebrogade 6E, 4. sal

82104 Bratislava

FI-01530 VANTAA

1411 København K

Technisches Service Center

Danmark

Raffineriestr. 18

Tel: +45 43 68 21 71

93333Neustadt / Donau

Fax:+45 43 31 48 99

Slovakia

Finland

Tel: +421 2 4821 4573

Tel: +358 9725 192 88

Fax: +421 2 4821 4501

Fax: +358 9725 192 89

Germany Tel: + 49 69 51 709670 Fax: + 49 69 29 9571608

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Preface

Table 1-1. Covidien International Service Centers (Continued) Covidien France SAS

Covidien Hong Kong

Covidien India

Covidien ECE s.r.o.

Parc d’affaires Technopolis

Unit 12 - 16, 18/F

10th Floor Building No 9B

Magyarországi Fióktelepe

Bat. Sigma, 3 Avenue du Canada

Millennium City 5

DLF Cyber City Phase III Gurgaon

Máriassy u.7

Haryana - 122002

Hungary

India

Tel: + 36 1 880 7975

Tel: + 91 1244 709800

Fax: + 36 1 778 9459

LP 851 Les Ulis 91975 Courtaboeuf Cedex France Tel: +33 1 57 32 35 10 Fax: +33 1 57 32 70 10

BEA Tower 4187 Kwun Tong Road Kwum Tong, Kowloon, Hong Kong Tel: + 852 2574 3251 Fax: + 852 2838 0749

1095 Budapest

Fax: + 91 1244 206850

Covidien Ireland

Covidien Israel

Covidien Italia S.p.A

Covidien Japan Inc.

Block G, Ground Floor,

5, Shacham St.

S. Bovio 3

Cherrywood Technology Park,

North Industrial Park

Technical Support Center

PO Box 3069

20090 S. Felice di Segrate (MI)

Loughlinstown

Caesarea, Israel

Italy

83-1, Takashimadaira 1Chome

Dublin 18, Ireland

3088900

Tel: +353 0 1 4073173

Itabashi-ku, Tokyo 1750082

Tel: +972 4 6277388

Tel: +39 02 91483320 (option 3)

Fax: +353 0 1 9075668

Fax: +39 02 91294863

Japan

Fax:+972 4 6370053

Tel: +81 0 3 6859 0120 Fax: +81 0 3 6859 0142

Covidien Korea

Covidien Mexico

5F, Hibrand Living Gwan, #215, Yangjae-Dong,

Av. Insurgentes Sur 863, Pisos 15 y 16 Col. Nápoles

Seocho-Gu

Del. Benito Juarez

Seoul, Korea

Mexico, D.F. 03810 Mexico

Tel: +822 6196 5459 Fax: +822 6196 5498

Tel: 5255 5804 1524

Covidien Nederland BV

Covidien New Zealand

Hogeweg 105 5301 LL Zaltbommel

Cnr Manu Tapu Dr & Joseph Hammond Pl.

Nederland

Auckland Airport

Tel: +31 202061470

New Zealand

Fax: +31 707 709229

Tel: + 64 508 489 264

Covidien Portugal Lda.

Fax: 5255 5536 1326

Covidien Norge AS

Covidien Panama

Covidien Polska

Postboks 343

Parque Industrial Costa del Esta

Al. Jerozolimskie 182

Calle Primera, Edifio # 109

Polska

N-1372 Asker. Norway Tel: +47 2415 9887 Fax: +47 2302 4955

Panama City, Panama Tel: 507 264-7337

02-222 Warszawa Tel: +48 22 279 04 05 Fax: +48 22 279 04 03

Estrada do Outeiro de Polima, Lote 10, 1° Piso Abóboda 2785-521 S. Domingos de Rana Portugal

Fax: 507 236-7408

Tel: +351 21 761 62 44 Fax: +351 800 781385

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Covidien Puerto Rico

Covidien Russia

Covidien Saglik A.S.

Covidien South Africa

Palmas Industrial Park

53 bld. 5 Dubininskaya

Corporate Park North

Road 869 Km 2.0 Bdlg. #1

Street Moscow

Maslak Mahallesi Bilim Sokak No: 5, Sun Plaza Kat: 2-3

Russia 119054

379 Roan Crescent

Sisli, Istanbul 34398

Randjespark Midrand, South Africa

Turkey

Tel: +27 115 429 500

ext. 7222 & 7221

Tel: +90 212 366 20 00

Fax: +27 115 429 624

Fax: 787 993 7234

Fax: +90 212 276 35 25

Cataño, PR 00962

Tel: +70 495 933 64 69

Tel: 787 993 7250

Fax: +70 495 933 64 68

Service Manual

Service Centers

Table 1-1. Covidien International Service Centers (Continued) Covidien Spain S.L.

Covidien Sverige AB

Covidien Switzerland

Covidien Thailand

Servicio Técnico WTC Almeda Park

Box 54

Roosstrasse 53

99 Soi Rubia

171 74 Solna

Ch-8832 Wollerau

Sukhumvit 42 Road

Plaça de la Pau, S/N Edif. 7, 3a Planta 08940 Cornellá de Llobregat (Barcelona)

Sweden

Schweiz

Tel: +46 8 517 615 73

Tel: +41 44 511 82 71

13-14 Fl., Berli Jucker Building

Fax: + 46 8 502 521 10

Fax: +41 44 511 16 34

Prakanong, Klongtoney

Spain

Bangkok 10110, Thailand

Tel: +34 91 275 48 54 (option 3)

Tel: +66 2 207 3 100 Fax: +66 2 657 6325

Fax: +34 91 276 89 33 Covidien UK

Covidien USA

Unit 2, Talisman Business Park

2101 Faraday Ave

London Road, Bicester OX26 6HR, United Kingdom

Phone: 1 800 255 6774 (option 4)

Carlsbad, CA 92008 Email: [email protected]

Tel: +44 20 3027 1757 Fax: +44 20 3684 8869

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Preface

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Service Manual

Contents

1

Preface... About This Manual... Qualification of Personnel... Electromagnetic Susceptibility... Warranty... Extended Service... Customer Assistance... Year of Manufacture... Manufacturer... Service Centers...

P-1 P-1 P-1 P-1 P-2 P-2 P-2 P-2 P-2 P-3

Safety Information...

1–1 1–1 1–1

1.1 1.2

2

General Information... 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13

3

Definitions... Warnings...

About This Manual... Product Description... Specifications... Range, Resolution, and Accuracy... Default Settings... Compliance and Approvals... 2.6.1 Manufacturer’s Declaration... Tools, Equipment, and Service Materials... Preventive Maintenance... 2.8.1 Preventive Maintenance Parts... Controls, Indicators, and Interfaces... Symbols, Abbreviations, and Internal Labels... Ventilator Serial Number and Software Versions... How to Configure the Ventilator... Service Philosophy...

Theory of Operation... 3.1 3.2 3.3 3.4

Service Manual

Operational Overview... Safety Net... Ventilator Components... Pneumatic System... 3.4.1 Inlet Air Filter... 3.4.2 Low Pressure Oxygen Inlet/Valve... 3.4.3 Oxygen Solenoid Valve...

2–1 2–1 2–2 2–5 2–8 2–14 2–15 2–16 2–22 2–25 2–28 2–29 2–38 2–42 2–42 2–46 3–1 3–1 3–2 3–3 3–4 3–4 3–4 3–4

i

Contents

3.5

3.6

4

Alarms and Troubleshooting... 4–1 4.1 4.2

4.3

ii

3.4.4 Inlet Silencer... 3–4 3.4.5 Turbine Assembly... 3–5 3.4.6 Outlet Silencer... 3–5 3.4.7 Exhalation Solenoid Valve... 3–5 3.4.8 Inspiratory Block... 3–6 3.4.9 Inspiratory Flow Sensor... 3–7 3.4.10 Proximal Pressure Sensor... 3–7 3.4.11 Inspiratory Pressure Sensor... 3–7 3.4.12 Exhalation Valve (Internal Valve) Pressure Sensor... 3–7 3.4.13 Barometric Pressure Sensor... 3–7 3.4.14 Patient Circuit... 3–7 Electrical System... 3–8 3.5.1 Power Management PCBA... 3–9 3.5.2 AC to DC Conversion... 3–9 3.5.3 DC Voltage Conversion and Distribution... 3–9 3.5.4 Internal Battery Charging and Discharging... 3–10 3.5.5 Power Source Priority and Switching... 3–10 3.5.6 USB Interface... 3–11 3.5.7 Microcontroller Functions... 3–11 3.5.8 CPU PCBA... 3–12 3.5.9 Breath Delivery Functions... 3–12 3.5.10 LCD Panel Interface... 3–13 3.5.11 Power Management PCBA Communication... 3–13 3.5.12 Status and Error Monitoring... 3–13 3.5.13 Memory... 3–13 3.5.14 Turbine Control PCBA... 3–14 3.5.15 Buzzer PCBA... 3–14 3.5.16 Battery Connection PCBA... 3–14 3.5.17 Internal Battery... 3–14 3.5.18 Ventilator Compartment Temperature Sensor... 3–15 3.5.19 Fan... 3–15 Ventilation Features... 3–15 3.6.1 Vt Target... 3–15 3.6.2 Leak Compensation... 3–15 3.6.3 Circuit Detection and Management... 3–16 3.6.4 Relative or Absolute Pressure... 3–16 3.6.5 Invasive or Non-invasive Ventilation... 3–16 3.6.6 FiO2 for Various Oxygen and Ventilator Settings... 3–17

Alarm Classification... How to Respond to Alarms... 4.2.1 How to Pause the Audible Portion of an Alarm... 4.2.2 How to Pause an Alarm... 4.2.3 How to Reactivate a Paused Alarm... 4.2.4 Alarm Reset Function... How to Access Stored Ventilator Diagnostic Logs... 4.3.1 Alarm Log... 4.3.2 Technical Fault Log...

4–1 4–3 4–3 4–4 4–5 4–6 4–7 4–7 4–7

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Contents

4.3.3 Event Log... Troubleshooting... 4.4.1 Troubleshooting Technical Faults... 4.4.2 Troubleshooting Ventilation Alarm Messages... 4.4.3 Troubleshooting Miscellaneous Symptoms... 4.4.4 PCBA Test Points...

4–9 4–9 4–10 4–12 4–33 4–34

Service and Repair...

5–1 5–1 5–2 5–2 5–3 5–3 5–3 5–4 5–4 5–4 5–4 5–5 5–9 5–9 5–9 5–10 5–12 5–13 5–14 5–17 5–17 5–19 5–20 5–24 5–26 5–28 5–29 5–31 5–33 5–34 5–36 5–37 5–39 5–39 5–40 5–44 5–45 5–46

4.4

5

5.1 5.2 5.3 5.4 5.5 5.6

5.7

5.8

6

Warnings... Electrical Cables and Pneumatic Tubing... Electrostatic Discharge Control... 5.3.1 ESD Procedures and Precautions... Replacement Part Ordering... Patient System and Accessories... Service Prerequisites... 5.6.1 Cleaning... 5.6.2 Labeling Checks... 5.6.3 External Inspection... 5.6.4 Measurement Check... 5.6.5 Review Technical Fault Log... Ventilator Repair... 5.7.1 Inlet Air Filter Removal and Replacement... 5.7.2 Power Switch Cover Replacement... 5.7.3 Adhesive Feet Removal and Replacement... 5.7.4 Battery Removal and Replacement... 5.7.5 Housing Disassembly and Assembly... 5.7.6 Carrying Handle Removal and replacement... 5.7.7 Keypad Removal and Replacement... 5.7.8 Exhalation Solenoid Valve Removal and Replacement... 5.7.9 CPU PCBA Removal and Replacement... 5.7.10 LCD Panel Removal and Replacement... 5.7.11 3V Battery Removal and Replacement... 5.7.12 Inspiratory Block Removal and Replacement... 5.7.13 Buzzer PCBA Removal and Replacement... 5.7.14 Oxygen Solenoid Valve Removal and Replacement... 5.7.15 Turbine Assembly Removal and Replacement... 5.7.16 Turbine Control PCBA Removal and Replacement... 5.7.17 Turbine Foam Pads Removal and Replacement... 5.7.18 Power Management PCBA Removal and Replacement... 5.7.19 Fan Removal and Replacement... 5.7.20 Battery Connection PCBA Removal and Replacement... 5.7.21 Remote Alarm (Nurse Call) Cable Removal and Replacement... 5.7.22 Oxygen Connector/Tube Assembly Removal and Replacement... 5.7.23 Lower Housing Replacement... Post-ventilator Repair Information...

Performance Verification... 6.1 6.2

Service Manual

Test Prerequisites... When to Run Performance Verification...

6–1 6–1 6–2

iii

Contents

6.3 6.4 6.5 6.6

6.7 6.8 6.9

6.10

6.11

6.12 6.13 6.14

6.15 6.16 6.17

7

Required Materials and Equipment... 6–4 6.3.1 PTS 2000 Setup... 6–5 Electrical Safety Test... 6–6 Power-on Indicators Check... 6–8 Ventilator Configuration... 6–8 6.6.1 Accessing the Setup Screen... 6–8 6.6.2 Change Language, Date, Time, or Other Settings... 6–9 6.6.3 Entering Maintenance Mode... 6–9 Technical Fault Check... 6–10 Measurements Check... 6–11 Calibration... 6–15 6.9.1 Patient Pressure Sensor Calibration... 6–15 6.9.2 Exhalation Valve (Internal Valve) Pressure Sensor Calibration... 6–17 6.9.3 Inspiration Flow Calibration... 6–17 Flow Sensor Capacity Test... 6–19 6.10.1 Turbine Performance Test... 6–19 6.10.2 Oxygen Solenoid Functional Test... 6–21 Breath Delivery Accuracy Tests... 6–23 6.11.1 Test Prerequisites... 6–23 6.11.2 Pediatric Pressure Accuracy... 6–24 6.11.3 Adult Pressure Accuracy... 6–25 AC/DC/Battery Power Switching Test... 6–26 Remote Alarm Test... 6–28 Alarms Tests... 6–31 6.14.1 AC Power Disconnection Alarm Test... 6–31 6.14.2 Patient Disconnect Alarm... 6–32 6.14.3 Power Off While Ventilating Test... 6–32 Set Default Parameters/Time & Date Verification... 6–33 Clear Faults... 6–35 Reset Patient Hours... 6–35

Parts List... 7–1 7.1 7.2 7.3 7.4 7.5 7.6

How to Use the Parts Lists... 7–1 Major System Components... 7–2 Electrical System Components... 7–5 Pneumatic System Components... 7–7 Turbine Assembly Components... 7–9 Label Kit... 7–11

A Appendix A... A.1

iv

Overview...

A–1 A–1

Service Manual

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

Service Manual

Control Panel... Puritan Bennett 520 Ventilator Front View... Puritan Bennett 520 Ventilator Rear View... Top View... Bottom View... Side View... Puritan Bennett 520 Ventilator Setup Screen... Maintenance Screen on Puritan Bennett 520 Ventilator... Setup 2 Menu... Service Process... Exhalation Solenoid Valve... Puritan Bennett 520 Ventilator with Single Limb Circuit... FiO2 for Various Oxygen and Ventilator Settings... Alarm display messages... Alarm Settings Menu During Audio Paused Period... Alarm Settings Menu During Alarm Paused Condition... Alarm Log Screen (with and without alarms in the log)... Maintenance Screen... Faults Screen With No faults Present... Selecting Measurement Check... Measurement Check Screen... Removing the Inlet Air Filter... Switch Cover, Spring, and Pin Detail... Power Switch Cover Spring Position Detail... Removing/Replacing the Battery... Removing Top Cover... Disconnecting the Keypad Flex Circuit... Replacing the Keypad... Pneumatic Tubing Connections (top view)... CPU PCBA Cables and Tubes (top view)... CPU PCBA Tubing Connections (underside view)... Pneumatic Tubing Diagram... Removing the LCD Panel... LCD Flex Circuit Detail... Removing the 3V Battery (LCD panel removed)... Replacing the 3V Battery... Installing the Inspiratory Block... Buzzer PCBA and Cable Detail...

2–29 2–32 2–33 2–35 2–36 2–38 2–43 2–45 2–45 2–46 3–6 3–8 3–17 4–3 4–4 4–5 4–6 4–8 4–9 5–6 5–6 5–10 5–11 5–12 5–13 5–15 5–16 5–18 5–19 5–21 5–22 5–23 5–25 5–26 5–27 5–28 5–29 5–30

v

Figures

Figure 5-20. Figure 5-21. Figure 5-22. Figure 5-23. Figure 5-24. Figure 5-25. Figure 5-26. Figure 5-27. Figure 5-28. Figure 5-29. Figure 5-30. Figure 5-31. Figure 5-32. Figure 5-33. Figure 5-34. 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 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure A-1. Figure A-2. Figure A-3.

vi

How to properly set the Buzzer PCBA switch (underside of PCBA shown)... 5–31 Oxygen Valve Detail... 5–32 Power Management/ Turbine Control Cable Detail... 5–33 Turbine Control PCBA... 5–35 Turbine support pad detail... 5–36 Upper Turbine Pad Detail... 5–37 Power Management PCBA Mounting Screw Locations... 5–38 Fan Detail... 5–39 Battery Connection PCBA... 5–40 Remote Alarm Cable and Oxygen Tubing Detail... 5–41 Remote Alarm Harness... 5–41 Aligning the Tab on the Harness Connector With the Notch on the Housing... 5–42 Orientation of the Connector and Tightening Locking Nut... 5–42 Remote Alarm Harness Installed Into Ferrite... 5–44 Oxygen Connector Properly Oriented... 5–45 PTS 2000 Setup... 6–5 Setup Screen on Puritan Bennett 520 Ventilator... 6–9 Maintenance Screen... 6–10 Measurements Check Screen... 6–11 Pressure Sensor Calibration Test Setup... 6–16 Inspiration Flow Calibration Test Setup... 6–17 Test Setup for Turbine Performance Test... 6–20 Expected Turbine Performance Test Patient Pressure Reading... 6–21 Oxygen Solenoid Test Setup... 6–21 Pediatric Pressure Test Setup... 6–24 Adult Pressure Accuracy Test Setup... 6–25 Power Switching Test Setup (rear view)... 6–27 Power Switching Test Setup (front view)... 6–27 Remote Alarm Test Setup (front view)... 6–29 Remote Alarm Test Box Connected to Ventilator (rear view)... 6–29 Remote Alarm Pin Diagram... 6–30 Major System Components... 7–4 Major Electrical Assemblies... 7–6 Pneumatic Components and Connection Diagram... 7–8 Turbine Assembly Drawing... 7–10 Front Panel Labels... 7–12 Rear Panel Labels... 7–13 Bottom Panel Label... 7–14 Pneumatic Block Diagram... A–1 Power Management PCBA Block Diagram... A–2 Exhalation Solenoid Valve During Inspiration And Exhalation... A–3

Service Manual

Tables Table 1-1. Table 2-1. Table 2-2. Table 2-3. Table 2-4. Table 2-5. Table 2-6. Table 2-7. Table 2-8. Table 2-9. Table 2-10. Table 2-11. Table 2-12. Table 2-13. Table 2-14. Table 2-15. Table 2-16. Table 2-17. Table 2-18. Table 2-19. Table 2-20. Table 2-21. Table 2-22. Table 3-1. Table 3-2. Table 4-1. Table 4-2. Table 4-3. Table 4-4. Table 5-1. Table 5-2. Table 6-1. Table 6-2. Table 6-3. Table 6-4. Table 6-5. Table 6-6.

Service Manual

Covidien International Service Centers... Puritan Bennett 520 Ventilator Accessories... Consumable Parts for the Puritan Bennett 520 Ventilator... Puritan Bennett 520 Ventilator Specifications... Puritan Bennett 520 Ventilator Range, Resolution, and Accuracy... Default Puritan Bennett 520 Ventilator Settings... Default Puritan Bennett 520 Ventilator Alarm Settings... Default Puritan Bennett 520 Ventilator Preferences (after software download)... Ventilator Compliance with Standards... Electromagnetic Emissions... Electromagnetic Immunity... Electromagnetic Immunity - Conducted and Radiated RF... Recommended separation distances Between Portable and Mobile RF Communications Equipment and the Puritan Bennett 520 Ventilator . . Compliant Cables and Accessories... Tools, Equipment, and Service Materials... Preventive Maintenance Schedule... Preventive Maintenance Parts List... Puritan Bennett 520 Ventilator Control Panel Keys and Indicators... Puritan Bennett 520 Ventilator Front Panel... Puritan Bennett 520 Ventilator Rear Panel Labels and Markings... Puritan Bennett 520 Ventilator Bottom Panel... Puritan Bennett 520 Ventilator Side Panel... Puritan Bennett 520 Ventilator On-screen Symbols, Abbreviations, and Internal Labels... Pneumatic Component Operating Ranges... Power source Switching Priority... Alarm Priority Classification... Technical Fault Error Troubleshooting Guide... Ventilation Alarm Troubleshooting Guide... Miscellaneous Symptom Troubleshooting Guide... Specifications for Measurement Check Verification... Testing and Calibration Requirements... Testing and Calibration Requirements... Electrical Safety Test Limits... Measurements Check Specifications... Default Ventilator Settings... Default Alarm Settings... Default Preferences...

1–3 2–2 2–4 2–5 2–9 2–14 2–14 2–14 2–15 2–17 2–18 2–19 2–21 2–22 2–23 2–26 2–28 2–29 2–32 2–33 2–37 2–38 2–39 3–4 3–11 4–2 4–10 4–13 4–33 5–7 5–46 6–2 6–6 6–12 6–34 6–34 6–34

vii

Tables

Table 7-1. Table 7-2. Table 7-3. Table 7-4. Table 7-5. Table 7-6. Table 7-7. Table 7-8. Table 7-9.

viii

Abbreviations... 7–1 Major System Component Part Numbers... 7–2 Electrical system component part numbers... 7–5 Pneumatic System Component Part Numbers... 7–7 Turbine Assembly Component Part Numbers... 7–9 Label Kit, P/N10000561... 7–11 Front Panel Labels... 7–12 Rear Panel Labels... 7–13 Bottom Panel Label... 7–14

Service Manual

1 Safety Information 1.1

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

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

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.

Please take the time to familiarize yourself with the following caveats as they cover safety considerations, special handling requirements, and regulations that govern the use of the Puritan Bennett™ 520 Ventilator.

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Warnings

General Warnings

• Not all clinical warnings are included in this service manual. The service manual is not intended for clinical use. Please consult the Puritan Bennett 520 Ventilator Clinician’s Manual for clinicalrelated warnings.

Fire Hazard Warnings

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

• In case of fire or a burning smell, immediately disconnect the ventilator from the oxygen supply, facility power, and battery. 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.

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Safety Information

• Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. (Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen.)

• The ventilator must not be used with flammable anesthetic substances. • Never expose any batteries to direct flame. Warnings for General Repair Safety

• To ensure proper servicing and avoid the possibility of physical injury, only qualified personnel should attempt to service or make authorized modifications to the ventilator.

• To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by disconnecting the power source and turning off all ventilator power switches before servicing. Follow accepted safety practices for electrical equipment when testing or making equipment adjustment, or repairs.

• When replacing the ventilator's internal battery, the ventilator must be disconnected from all external power supplies and turned off.

• When servicing the ventilator, be sure to familiarize yourself with, and adhere to all posted and stated safety warning and caution labels on the ventilator and its components, and on any service equipment and materials used. Failure to adhere to such warnings and cautions at all times may result in injury or property damage.

• To prevent personal injury or death, do not attempt any ventilator service while a patient, or other person, is connected to the ventilator.

• Never touch the ventilator's internal components, including the battery, and the patient simultaneously.

• To ensure proper performance of the ventilator, follow the preventive maintenance schedule listed in Table 2-15.

• To prevent possible personal injury, always disconnect the oxygen source from the ventilator before service.

• 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 2-14.

• Do not clean any gas pathway with a liquid cleaner. Refer to Table 2-14 for allowable cleaning and disinfecting agents for use on other parts of the ventilator.

• Use personal protective equipment whenever exposure to toxic fumes, vapor, dust particles, blood pathogens, and other transmittable diseases and hazardous material can be expected. If in doubt, consult an environmental health and safety specialist or an industrial hygienist before servicing the ventilator. Refer to Section 5.6.1 for cleaning procedure.

• Chemicals from a broken LCD panel are toxic when ingested. Use caution when handling a ventilator with a broken display panel.

• To prevent possible damage to the power supply, remove the battery from the ventilator (Section 5.7.4) during disassembly and reassembly.

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Service Manual

Safety Information

Warnings about Reducing Infection

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

• 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 bacteria filter at the ventilator's inlet is recommended. Refer to the “Cleaning” chapter in the Clinician’s manual.

• When handling any part of the ventilator, always follow appropriate infection control guidelines for handling infectious material.

• Covidien recognizes that cleaning, sterilization, sanitation, and disinfection practices vary widely among healthcare institutions. It is not possible for Covidien to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting.

• Covidien recommends that users of its products that require cleaning and sterilization/ disinfection consider the National Standards and Recommended Practices for Sterilization published by the Association for the Advancement of Medical Instrumentation (AAMI), as well as the following Center for Disease Control (CDC) publications: Guidelines for Maintenance of In-use Respiratory Therapy Equipment and Guidelines for Prevention of Nosocomial Pneumonia.

Warnings Before Using Equipment

• The Puritan Bennett 520 Ventilator is not intended for ventilator-dependent patients. • Ensure the Apnea Alarm is set to YES in the Preferences menu to enable an alarm tone if apnea occurs. If Apnea Alarm is set to OFF, the ventilator will still supply a backup rate during apnea conditions, but no alarm tone will sound.

• Ensure the Intentional Vent Stop alarm is set to YES in the Preferences menu to enable alarm tones and an alarm message if the ventilator is voluntarily turned off. If the Intentional Vent Stop alarm is set to OFF, an alarm will not sound, nor will a message appear when the ventilator is turned off in the normal manner.

• For a thorough understanding of ventilator operations, be sure to thoroughly read this manual and the Clinician’s manual before attempting to use the ventilator.

• The ventilator must be used only under the responsibility and on the prescription of a doctor. • Check the ventilator periodically as outlined in this manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated.

• Before activating any part of the ventilator, be sure to check the equipment for proper operation. • To prevent patient injury, do not use a ventilator if it requires repair. • 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.

• Verify the functionality of the alarms before making ventilator available for patient use. • Do not perform ventilator alarm tests while the patient is connected to the ventilator.

Service Manual

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Safety Information

• If the ventilator fails any alarm tests, refer to Chapter 5 to service appropriate components. Refer to Table 4-3 to troubleshoot specific alarm messages.

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

• To minimize the risk of damage, you must use the ventilator's factory approved packaging to transport the ventilator.

• Do not use the ventilator without a properly installed inlet air filter or with a dirty inlet air filter. • The inlet air filter is not reusable. Do not attempt to wash, clean, or reuse it. • If you cannot determine the cause of a problem with the ventilator, contact Covidien Technical Support or your local representative. Do not use the ventilator on a patient until the problem has been corrected.

• To avoid injury and/or possible damage to the ventilator: before using the ventilator, use a flow meter (flow regulator) to regulate the oxygen supply to specifications before connecting the ventilator to the oxygen supply.

General Warnings Regarding Use of Equipment

• The ventilator must be used only under the responsibility and on the prescription of a doctor. • Patients on mechanical ventilation should be appropriately monitored by competent medical personnel and suitable monitoring devices.

• An alternative source of ventilation should always be available when using the Puritan Bennett 520 Ventilator.

• 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.

• Do not use sharp objects to make selections on the keyboard. • Do not clean any gas pathway (including the patient circuit) with a liquid cleaner. Refer to Table 2-14 for allowable cleaning and disinfecting agents for use on other parts of the ventilator.

• 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 2-14.

• The SET UP menu is only accessible if ventilation is stopped and the ventilator is powered on while the ALARM CONTROL key is pressed.

• A continuous alarm condition will be activated if the ventilator power is switched off during ventilation. When the power is switched back on, ventilation will resume without having to press the ventilator’s ON/OFF key.

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Service Manual

Safety Information

• 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 device’s lithium battery is below the 100 Wh 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 ensure correct and lasting operation of the device, ensure the ventilator is installed and operated in the environmental conditions recommended in Appendix B, “Specifications” of the Clinician’s manual.

• To ensure correct and lasting operation of the ventilator, ensure 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.

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

• If the ventilator has been transported or stored at a temperature that differs more than 20 °C ( 68 °F) from the temperature in which it will be operating, the ventilator should be allowed to stabilize in its operating environment for at least two (2) hours prior to use.

• If the ambient temperature is above 104 °F (40 °C), the battery's thermal cut-off circuit may prevent the battery from recharging fully-even if the INTERNAL BAT charging indicator indicates the battery is completely recharged.

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

• 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.

• 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 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 the connection of the patient circuit to the patient provides for a secure comfortable fit.

• 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.

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