560 Ventilator Users Manual Rev D May 2017

Table of Contents Preface Purpose of This Manual... xi Qualification of Personnel... xi Warranty... xi Extended Service... xi Technical Support... xii 1

Safety Information

1.1 1.2 1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.2.6 1.2.7 1.2.8 1.2.9 1.3 1.4 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 3 3.1 3.2

User Manual

Definitions... 1-1 Warnings... 1-1 General Warnings Regarding Use of Equipment... 1-1 Warnings Regarding Installation and Environment of Use... 1-4 Warnings Regarding Electrical Power Supplies... 1-6 Warnings Regarding Hoses and Accessories... 1-8 Warnings Regarding Settings...1-11 Warnings Regarding USB Memory Device...1-13 Warnings Regarding Maintenance ...1-13 Warnings Regarding Oxygen...1-17 Warnings Regarding Electromagnetic Interference...1-19 Symbols and Markings... 1-19 Labels/Identification and Instruction Information... 1-24 Ventilator Overview Indications for Use... 2-1 Contraindications... 2-2 Operational Use... 2-2 Device Classification... 2-3 Front Panel... 2-4 Back Panel... 2-5 Control Panel... 2-6 Ventilation Menu... 2-7 Alarm Menu... 2-8 Waveforms Menu... 2-9 USB Memory Device Menu... 2-10 If Ventilator Failure Occurs... 2-10 Alarms and Troubleshooting Alarm Level of Priority... 3-2 Alarm Display... 3-2

iii

3.3 3.4 3.5 3.6 3.7 3.8 3.8.1 3.8.2 4

Installation and Assembly

4.1 4.2 4.3 4.4 4.4.1 4.4.2 4.5 4.5.1 4.5.2 4.6 4.7 4.8 4.8.1 4.8.2 4.8.3 4.9 4.10 4.11 4.12 5

5.2.1 5.2.2 5.2.3 5.2.4

iv

Installing the Ventilator ... 4-1 Connecting to External AC Power... 4-3 Connecting to an External DC Power Source... 4-6 Patient Circuit... 4-8 Choosing the Patient Circuit Type...4-10 Installing the Patient Circuit...4-10 Filters ... 4-15 Air Inlet Filter...4-15 Bacteria Filter...4-16 Humidifier... 4-17 Exhalation Block... 4-18 Oxygen... 4-19 Administering Oxygen...4-19 Connecting the Oxygen Supply...4-20 Connecting the FiO2 sensor...4-22 Fitting the Ventilator into the Dual Bag... 4-23 Mounting the Ventilator on a Wheelchair... 4-24 Mounting the Ventilator on the Utility Cart... 4-26 Connecting the Nurse Call Cable... 4-27 Operating Procedures

5.1 5.2

5.3 5.4 5.5

Alarm Logs Menu... 3-4 Pausing the Audible Portion of Alarms... 3-5 Pausing/Resetting Alarms... 3-6 Reactivating Alarms... 3-7 Overview of Alarms... 3-9 Troubleshooting... 3-16 Alarms...3-16 Additional Troubleshooting...3-30

Turning on the Ventilator... 5-1 USB Menu Parameters... 5-4 USB Memory Device Specifications... 5-4 USB Menu... 5-5 Transfer Continuously... 5-5 Transfer Trends... 5-7 Starting Ventilation... 5-8 Stopping Ventilation... 5-10 Turning Off the Ventilator... 5-11

User Manual

Table of Contents 6

Internal Battery

6.1 6.2 6.3 6.4 6.5

Battery Capacity... 6-1 Battery Operation... 6-2 Testing the Battery... 6-4 Recharging the Battery... 6-5 Storage... 6-6

7

Cleaning

7.1 7.2 7.3

Cleaning the Ventilator... 7-1 Cleaning the Accessories... 7-2 Cleaning the Exhalation Block... 7-3

8

Routine Maintenance

8.1 8.2 8.3

Replacing the Air Inlet Filter... 8-1 Recommended Schedule of Maintenance... 8-2 Service Assistance... 8-4

A

Specifications

A.1 A.2 A.3 A.4 A.4.1 A.5 A.6 A.7 A.8 A.9 A.10 A.11 B

Modes of Ventilation

B.1 B.1.1 B.1.2 B.1.3 B.1.4

User Manual

Physical... A-1 Electrical... A-1 Indicators and Alarms... A-3 Performance... A-3 Specifications...A-3 Monitored Parameters... A-4 Range, Resolution, and Accuracy... A-4 Environmental... A-8 USB... A-8 Pneumatic... A-9 Manufacturer’s Declaration...A-10 Standards Compliance and IEC Classification ...A-15

Modes of Ventilation... B-1 Assist/Control (A/C) Modes...B-1 SIMV Modes...B-1 CPAP Mode...B-2 PSV Mode...B-2

v

C

Operational Verification Checklist

D

Unpacking and Preparation

E

Alarms Tests

E.1 E.2 E.2.1 E.2.2 E.3 E.4 E.5 E.6

vi

Low Pressure Test... E-1 Circuit Check Test... E-2 Performing a Circuit Check... E-2 Troubleshooting a Failed Check... E-4 Power Failure Test... E-5 Occlusion Test... E-5 Battery Test... E-6 Involuntary Stop Test... E-7

F

Parts and Accessories

G

Glossary

User Manual

List of 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 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 4-16. Figure 4-17. Figure 4-18. Figure 4-19. Figure 4-20. Figure 5-1. Figure 5-2. Figure 5-3. Figure 5-4. Figure 5-5.

User Manual

Locations of Labels-Top-Front View... 1-25 Locations of Labels-Front-Left View... 1-26 Location of Labels and Markings-Rear View... 1-26 Location of Labels-Bottom View... 1-27 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 Accessing Alarm Logs Menu... 3-4 Alarm Logs Screen... 3-4 Alarm Logs Screen when No Alarm Activated... 3-5 Pausing the Audible Portion of Alarms... 3-6 Manually Pausing Alarms... 3-7 Reactivating Alarms... 3-8 Alarm Logs... 3-8 The Power Cable Holder... 4-4 Inserting the Power Cable Holder into the Notch... 4-4 Power Cable Connected to the Ventilator... 4-5 Power Indicators... 4-6 Connecting the Ventilator to an External DC Power Source... 4-7 Connecting the DC Power Cable to the Ventilator... 4-8 Single-Limb Patient Circuit With Exhalation Valve... 4-11 Double-Limb Patient Circuit... 4-12 Closeup of Exhalation Valve Tube and Proximal Pressure Tube... 4-13 Single-Limb Patient Circuit Without Exhalation Valve... 4-14 Air Inlet Filter... 4-16 Bacteria Filter... 4-17 Humidifier... 4-18 Removing the Exhalation Block... 4-19 Rear Panel Oxygen Connector... 4-20 Connecting the Oxygen Supply System... 4-21 Disconnecting the Oxygen Supply System... 4-22 Connecting the FiO2 sensor... 4-23 Using the Dual Bag Accessory... 4-25 Connecting the Nurse Call Cable... 4-27 Turning on the Ventilator... 5-2 Welcome Menu Screen... 5-3 Ventilation Menu Parameters... 5-4 Selecting the USB Menu... 5-5 Selecting Transfer Continuously... 5-6

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Figure 5-6. Figure 5-7. Figure 5-8. Figure 5-9. Figure 5-10. Figure 6-1. Figure 6-2. Figure 6-3. Figure 6-4. Figure 8-1. Figure D-1. Figure D-2. Figure E-1. Figure E-2. Figure E-3. Figure E-4. Figure E-5. Figure E-6.

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Selecting Transfer Trends... 5-7 Prompt to Start Ventilation... 5-9 Starting Ventilation... 5-10 Stopping Ventilation (1)... 5-10 Stopping Ventilation (2)... 5-11 Internal Battery Indicator... 6-3 Battery Reserve Capacity as a Percentage... 6-3 Battery Reserve Capacity in Hours and Minutes... 6-4 Power Indicators when Charging the Battery... 6-5 Replacing the Air Inlet filter... 8-2 Puritan Bennett 560 Ventilator... D-2 Dual Bag... D-3 Circuit Check Screen (Before Starting)... E-2 Blocking the Patient End of a Single Limb Circuit... E-3 Circuit Check (Running)... E-3 Circuit Check (Complete, Passed)... E-4 Circuit Check (Complete, Failed)... E-4 Blocking the Patient End of a Patient Circuit... E-6

User Manual

List of Tables Table 1-1. Table 1-2. Table 3-1. Table 3-2. Table 3-3. Table 5-1. Table 5-2. Table 6-1. Table 7-1. Table 8-1. Table A-1. Table A-2. Table A-3. Table A-4. Table A-5. Table A-6. Table A-7. Table A-8. Table A-9. Table A-10. Table A-11. Table A-12. Table A-13. Table A-14. Table A-15. Table A-16. Table A-17. Table A-18. Table A-19. Table A-20. Table A-21. Table A-22. Table A-23. Table A-24. Table C-1. Table F-1. Table F-2.

User Manual

Ventilator Symbols... 1-19 Ventilator Labels and Markings... 1-24 Overview of Alarms... 3-9 Alarms and Corrective Actions... 3-17 Additional Troubleshooting and Corrective Actions... 3-30 USB Memory Device Specifications... 5-4 Time taken to transfer trends data from the ventilator to a USB memory device... 5-8 Internal Battery Reserve Capacity... 6-2 Approved Cleaning Solutions for Exterior Ventilator Surfaces... 7-2 Consumables and Replacement Intervals... 8-2 Physical Description (Excluding Accessories)... A-1 AC Electrical Supply... A-1 Internal Lithium Ion Battery... A-2 Remote Alarm... A-2 Power Indicators... A-3 Alarm Indicators... A-3 Audio Alarms... A-3 Performance Parameter Specifications and Tolerances... A-3 Monitored Parameter Tolerance... A-4 Ventilator Range, Resolution, and Accuracy... A-5 Environmental Conditions for Storage or Transport... A-8 Environmental Conditions for Operation... A-8 USB Memory Device Specifications... A-8 Data Transfer Characteristics... A-9 Airway Resistances... A-9 Patient Circuit Resistances... A-9 Air Inlet Resistance (Filter)... A-9 Oxygen Inlet Specifications... A-9 Performance Specifications... A-9 Electromagnetic Emissions... A-10 Electromagnetic Immunity... A-10 Electromagnetic Immunity-Conducted and Radiated RF... A-12 Recommended Separation Distances... A-13 Compliant Cables and Accessories... A-14 Operational Verification Checklist... C-1 List of Consumables and Accessories... F-1 List of Circuits... F-2

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Page Left Intentionally Blank

x

Preface Purpose of This Manual This manual contains important information regarding the safe operation of your Puritan Bennett™ 560 Ventilator. Your ventilator is an electrical device that can provide years of useful service with the proper care, as described in this manual. Ensure that you read and understand the instructions contained in this manual before operating the ventilator.



WARNING: Before operating the ventilator, read, understand, and strictly follow the information contained in Chapter 1, “Safety Information.”

Qualification of Personnel Installation and maintenance of the device must be made by authorized and trained personnel. In particular, training for the handling of products sensitive to electrostatic discharges must include the use of electrostatic discharge (ESD) protection devices and knowledge of the 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.

xi

Preface

For online technical support, visit the SolvITSM Center Knowledge Base by clicking the link at www.medtronic.com/covidien/ support/solvit-center-knowledge-base/. Here, you will find answers to frequently asked questions about the product and other Covidien products 24 hours a day, 7 days a week. If you require further assistance, contact your local Covidien representative.

Technical Support Technical service contacts: Covidien Argentina

Covidien Australia

Covidien Austria GmbH

Vedia 3616

52A Huntingwood Drive

Buenos Aires Argentina

Huntingwood, NSW 2148

Tel: 5411 4863 5300

Campus21 Europaring F09402 Brunn am Gebrige A-2345 Österreich

Tel: +61 1800 350702

Fax: 5411 4863 4142

Fax: +612 9671 8118

Tel: +43 1 20609 1143 Fax: +43 1 20609 2457

Covidien Belgie S.A.-N.V. Generaal De Wittelaan 9/5 Mechelen 2800 België

Covidien Brazil

Covidien Canada

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

19600 Clark Graham

São Paulo, SP

Canada

Brasil 04795-100

Tel: 1 877 664 8926 (option 2)

Tel: 5511 5683-8300

Fax: 1 514 695 7534

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

Australia

Baie d'Urfe, QC, H9X 3R8

Fax: 5511 5683-8349 Covidien Chile

Covidien Colombia

Covidien Costa Rica

Lo Boza 107

Edificio Prados de la Morea

Global Park, Parkway 50

Pudahuel

Carretera Central Del Norte

La Aurora, Heredia, 40104

Santiago de Chile, Chile

(Cra 7a)Kilometro 18,

Costa Rica

Tel: 562 231 3411

Chia-Cundinamarca

Tel: 506 256 1170

Fax: 562 231 3527

Bogota, Colombia

Fax: 506 256 1185

Tel: 571 619 5469

Fax: 506 290 8173

Fax: 571 619 5425 Covidien ECE s.r.o. organizační složka Covidien Danmark A/S Prosek, Prosecká 852/66 Langebrogade 6E, 4. sal 190 00 Praha 9 1411 København K

Covidien Deutschland GmbH

Tel:+420 241 095 735

Danmark

93333 Neustadt / Donau

Fax:+420 239 016 856

Tel: +45 43 68 21 71

Germany

Fax:+45 43 31 48 99

Tel: + 49 69 51 709670

Technisches Service Center Raffineriestr. 18

Fax: + 49 69 29 9571608

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User Manual

Technical Support

Technical service contacts: Covidien ECE

Covidien Finland Oy

Covidien France SA

Galvaniho 7/a

Rahtitie 3

Parc d’affaires Technopolis

821 04 Bratislava

FI-01530 Vantaa

Bat. Sigma, 3 Avenue du Canada

Slovenska Republika

Finland

LP 851 Les Ulis

Tel: +42 124 821 45 73

Tel: +358 9 725 192 88

91975 Courtaboeuf Cedex France

Fax: +42 124 821 45 01

Fax: +358 9 725 192 89

Tel: +33 1 57 32 35 10 Fax: +33 1 57 32 70 10

Covidien Hellas SA

Covidien Hungary

Covidien Ireland Commercial Ltd

8 Fragoklisias Street

1095 Budapest

Block G, Ground Floor,

Maroussi, 151 25

Mariassy u. 7

Cherrywood Technology Park,

Greece

Magyarorszag

Loughlinstown

Tel: +30 211 180 36 00

Hungary

County Dublin

Fax: +30 210 614 63 80

Tel: + 36 1880 7975

Ireland

Fax: + 36 1777 4932

Tel: +353 1 407 3173 Fax: +353 1 907 5668

Covidien Israel

Covidien Italia S.p.A.

Covidien Japan Inc.

5 Shacham St. North Industrial Park Caesarea 38900 Israel

Via S.Bovio 3

Technical Support Center

San Felice, 20090 Segrate (MI) Italy

83-1, Takashimadaira 1-Chome

Italy

Itabashi-ku, Tokyo 175-0082 Japan

Tel: +39 02 91483320 (option 3)

Tel: +81 0 3 6859 0120

Fax: +39 02 91294863

Fax: +81 0 3 6859 0142

Covidien Nederland BV

Covidien Norge AS

Tel: +97 246 277 388 Fax:+97 266 277 688 Covidien Mexico

Av. Insurgentes Sur 863, Pisos 15 y 16 Hogeweg 105

Postboks 343

Col. Nápoles

5301 LL Zaltbommel

1372 Asker.

Del. Benito Juárez

Nederland

Norway

México, D.F. 03810 México

Tel: +31 202061470

Tel: +47 2415 9887

Tel: 5255 5804 1524

Fax: +31 707 709229

Fax: +47 2302 4955

Covidien Panama

Covidien Polska

Covidien Portugal Lda.

Parque Industrial Costa del Esta

Al. Jerozolimskie 182 Warszawa. 02-222 Polska

Estrada do Outeiro de Polima, Lote 10-1° Abóboda

Tel: +48 22 279 04 05

Portugal

Fax: +48 22 279 04 03

Tel: +351 21 761 62 44

Fax: 5255 5685 1899

Calle Primera, Edifio # 109 Panama City, Panama Tel: 507 264-7337 Fax: 507 236-7408

2785-521 S.Domingos de Rana

Fax: +351 800 781385 Covidien Puerto Rico

Covidien Russia

Covidien Saglik A.S.

Palmas Industrial Park Road 869 Km 2.0 Bdlg. #1

53 bld. 5 Dubininskaya Street Moscow

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

Cataño, PR 00962

RUSSIA. 119054 Poccии

Sisli, Istanbul 34398

Tel.: 787 993 7250 (ext. 7222 & 7221)

Tel: +70 495 933 64 69 Fax: +70 495 933 64 68

Turkey

Fax: 787 993 7234

Tel: +90 212 366 20 00 Fax: +90 212 276 35 25

User Manual

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Preface

Technical service contacts: Covidien South Africa

Covidien Spain S.L.

Covidien Sverige AB

Corporate Park North 379 Roan Crescent Randjespark Midrand, South Africa Tel: +27 115 429 500 Fax: +27 115 429 547

Servicio Técnico

Box 54

WTC Almeda Park

171 74 Solna

Plaça de la Pau, S/N - Edif. 7, 3ª Planta Sweden 08940 Cornellá de Llobregat

Tel: +46 8 517 615 73

Barcelona, Spain

Fax: + 46 8 502 521 10

Tel: +34 91 275 48 54 (Opción 3) Fax: +34 91 276 89 33 Covidien Switzerland

Covidien UK & Ireland

Covidien Singapore

Roosstr. 53

Unit 2, Talisman Business Park

Singapore Regional Service Centre

Wollerau 8832 Schweiz

London Road, Bicester

15 Pioneer Hub, #06-04

OX26 6HR, United Kingdom

Singapore 627753

Tel: +44 20 3027 1757

Tel: 656578 5187 / 8 / 9

Fax: +44 20 3684 8869

Fax: 65 6515 5260

Tel: +41 44 511 82 71 Fax: +41 44 511 16 34

Email: [email protected]

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User 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.

It is essential to read, understand and follow these instructions before using the Puritan Bennett™ 560 Ventilator. In order to use the ventilator correctly and efficiently and to help prevent incidents, please pay particular attention to section 1.2, “Warnings,” as well as all warnings and cautions contained throughout this manual.



Note: Many of the functions of the ventilator are not accessible when the Locking key additional assistance contact your clinician or equipment representative.

1.2

is enabled. For

Warnings

1.2.1 General Warnings Regarding Use of Equipment



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

1-1

Safety Information

         1-2

WARNING: The ventilator must be used according to its intended use. Refer to section 2.1, “Indications for Use.” WARNING: Be aware this material describes how to respond to ventilator, but does not tell you how to respond to the patient. WARNING: While the ventilator is in use, an alternative means of ventilation should always be available in the event of a ventilator problem. This is particularly true for ventilator-dependent patients. Supplementary observation, appropriate for the patient’s condition, is also recommended. WARNING: To ensure that ventilation continues uninterrupted ensure alternative power sources are available (AC power source, extra batteries, or an auxiliary DC car adapter). Be prepared for the possibility of power failure by having an alternative means of ventilation ready for use-particularly for ventilator-dependent patients. WARNING: Do not allow a patient to remain connected to the ventilator when ventilation is stopped, because a substantial quantity of exhalation gas, primarily carbon dioxide, may be inhaled by the patient. In some circumstances, inhaling carbon dioxide may lead to under-ventilation, suffocation, and serious injury or death. WARNING: The ventilator must not be used with flammable anesthetic substances. WARNING: Do not start ventilation until you ensure that the device is suitably assembled, that the air inlet filter is properly installed and is not obstructed, and that there is proper clearance all around the unit. Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient circuit, including all hoses, is not damaged or obstructed. WARNING: A ventilator-dependent patient should always be monitored by trained and competent medical personnel. Ensure that the patient’s caregiver is able and prepared to take suitable action in the event the ventilator identifies an alarmed condition or experiences a problem. WARNING: Do not use a patient circuit with a leak accessory for ventilator-dependent patients.

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Warnings

        

User Manual

WARNING: Before dispensing the ventilator to caregivers or the patient for home use, ensure the Locking Key is activated so that critical ventilator settings are not modified. WARNING: Do not perform ventilator alarm tests while the patient is connected to the ventilator. Provide the patient with an alternate means of ventilation before conducting these tests. WARNING: Verify the functionality of the alarm conditions before connecting the patient to the ventilator. WARNING: If the ventilator fails the alarm tests or if you cannot complete the tests, refer to Chapter 3, “Alarms and Troubleshooting” or call your equipment supplier or Covidien. WARNING: When an alarm condition is triggered, or there is evidence of a patient-ventilator fault or problem, examine the patient first before examining the ventilator. WARNING: A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress. When the power switch is turned back on again, ventilation will resume without having to press the VENTILATION ON/OFF button. WARNING: To reduce the risk of infection, wash your hands thoroughly before and after handling the ventilator or its accessories. WARNING: A patient treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated equipment is a potential source of infection. Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection. The use of a bacterial filter at the ventilator’s outlet-or both ports if a double-limb circuit is used-is recommended. Refer to Chapter 7, “Cleaning. “ WARNING: Handle the ventilator with care during and after use, particularly when ambient temperatures are high. Some ventilator surfaces may become hot, even if safety specifications are not exceeded.

1-3

Safety Information

1.2.2 Warnings Regarding Installation and Environment of Use



     

1-4

WARNING: Even though the Puritan Bennett™ 560 Ventilator meets current safety standards, the internal Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the Puritan Bennett™ 560 Ventilator and/or the associated Lithium-ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport (IATA: International Air Transport Association), International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) for Europe. Private individuals who transport the device are excluded from these regulations although for air transport some requirements apply. For air transport; the Puritan Bennett™ 560 Ventilator is permitted as checked-in or carry-on baggage. Two spare batteries per person may be taken on board as carry-on luggage only, with the prior approval of the airline. This classification and regulatory requirements may vary depending upon the country and mode of transport. Therefore it is recommended that users verify with the carrier / airline as to which measures to take before the voyage. WARNING: To minimize the risk of damage, you must use the ventilator’s Dual Bag to transport the ventilator. See Table F-1. , List of Consumables and Accessories. WARNING: Regularly clean the ventilator’s Dual Bag according to manufacturer’s recommendations. WARNING: The ventilator should never be immersed in any liquid, and any liquid on the surface of the device should be wiped away immediately. WARNING: To avoid damage to the ventilator, in particular the batteries or electrical components, fluids must not be allowed to enter the device, particularly through the air inlet filter or the cooling apertures located in the side, rear, and bottom panels of the ventilator. WARNING: To ensure correct and lasting operation of the device, ensure that the ventilator is installed and operated in the environmental conditions recommended in Appendix A, “Specifications.” WARNING: Do not leave power cables lying on the ground where they may pose a hazard.

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Warnings

        

User Manual

WARNING: Do not operate the ventilator in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device. WARNING: Avoid using the ventilator, if possible, in dusty environments. Dusty environments may require more vigilant monitoring, cleaning, and/or replacement of air intake and other filters. WARNING: Ensure that the ventilator’s immediate surroundings allow for the proper operational connection of the device without folding, pinching, or damaging any of the required cables or tubes, and that the connection of the patient circuit to the patient provides for a secure, comfortable fit. WARNING: Place the ventilator in a safe place when ventilating and according to the recommendations in this manual. WARNING: Do not place the ventilator in a position where a child can reach it or in any position that might cause it to fall on the patient or someone else. WARNING: To ensure correct and lasting operation of the ventilator, ensure that its air circulation holes (main inlet or cooling) are never obstructed. Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics, such as curtains. WARNING: If the ventilator has been transported or stored at a temperature that differs more than 20°C ( 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. WARNING: 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. WARNING: The default setting for altitude compensation is YES. Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations.

1-5

Safety Information

  

WARNING: To reduce the risk of a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (such as flammable anesthetics and/or heaters) away from the ventilator and oxygen hoses. WARNING: Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator. If necessary, replace the filter before the recommended replacement period is over (see Chapter 8, “Routine Maintenance”). This is particularly important when the ventilator is installed on a wheelchair, because environmental conditions may cause the filter to become dirty more rapidly. WARNING: Handle the ventilator with care during and after use, particularly when ambient temperatures are high. Some ventilator surfaces may become hot, even if safety specifications are not exceeded.

1.2.3 Warnings Regarding Electrical Power Supplies

      1-6

WARNING: Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off. WARNING: The operator should connect the ventilator to an AC power source whenever available, for safer operation. WARNING: The maximum recommended shelf life of the internal battery is two (2) years. Do not use a battery that has been stored for two years prior to its first use. WARNING: Periodic recharging is important to help maximize useful life of the battery. Do not store the internal battery for extended periods, without recharging, as this may reduce the maximum life. WARNING: For the AC (“mains”) power cable to be properly secured, the attachment located on the power cable must be fitted into the power cable holder incorporated in the battery access cover and located under the AC (mains) power socket. Refer to section 4.2, “Connecting to External AC Power.” WARNING: The power supply to which the ventilator is connected (both AC and DC) must comply with all applicable standards and provide electrical power corresponding to the voltage characteristics

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Warnings

inscribed on the rear of the ventilator to ensure correct operation. Refer also to the electrical specifications found in Appendix A, “Specifications.”

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User Manual

WARNING: Ensure that the ventilator’s internal battery is fully charged before connecting the ventilator to an external DC power source. Powering the ventilator using an external 12– 30 VDC power source (via the DC power cable) does not enable its internal battery to recharge. WARNING: Due to 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. WARNING: When using a car auxiliary adapter (cigarette lighter) ensure the car has been started prior to plugging in the ventilator’s DC adapter. Refer to section 4.3, “Connecting to an External DC Power Source.” WARNING: Even if the “INTERNAL BATTERY” charging indicator is off, charging of the battery may sometimes be incomplete if the ambient temperature is above 40 °C (104 °F) because of the battery’s internal heat safety device. WARNING: When the “LOW BATTERY“ alarm is triggered, immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery. WARNING: Batteries should be disposed of according to environmental legislation in your country and locality. WARNING: Never expose any batteries to direct flame. WARNING: Ensure that the AC power cable is in perfect condition and not compressed. The device should not be turned on if the AC power cable is damaged.

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