Power Pack User Manual Rev B

Technical Support Contacts Covidien Argentina Estados Unidos 5180 (Complejo San Eduardo - Nave 4) CP:1667 Ciudad: Tortuguitas, Provincia: Buenos Aires, Argentina Tel: (5411) 4863-5300

Covidien Australia 52A Huntingwood Drive Huntingwood, NSW 2148 Australia Telephone (+61) 1800 350702

Covidien Austria GmbH Campus21 Europaring F09402 Brunn am Gebrige A-2345 Österreich Tel +43 223 637 88 39

Covidien Belgie S.A.-N.V. Generaal De Wittelaan 9/5 Mechelen 2800 België Tel +32 152 981 37

Covidien Brazil Av. Das Nações Undias 12995 Andar 23 - Brooklin São Paulo, SP Brasil 04578-000 Tel: (5511) 2187-6200

Covidien Canada 19600 Clark Graham Baie d'Urfe, QC, H9X 3R8 Canada Tel: 1-514-332-1220

Covidien Chile Rosario Norte 530, Piso 12 Las Condes Santiago de Chile, Chile Tel: (562) 231-3411

Covidien Colombia Edificio Prados de la Morea Carretera Central Del Norte (Cra 7a)Kilometro 18, Chia-Cundinamarca Bogota, Colombia Tel:(571)668-3777

Covidien Costa Rica De la Panasonic, 1 km al Sur y 400 m al Oeste, Ofibodegas del Oeste, Bodega #6 Lindora, San Jose, Costa Rica Tel: (506) 2239 - 4124

Covidien Czech Republic Covidien ECE s.r.o. Technical service Galvaniho 7/a 821 04 Bratsilava Slovakia

Covidien Danmark A/S Tel +45 702 753 50 Arne Jacobsens Allé 7 5 sal DK-2300 COPENHAGEN S DENMARK (commercial only)

Covidien Deutschland GmbH Technisches Service Center Raffineriestr. 18 93333 Neustadt / Donau Germany Tel +49 (0) 9445 959381

Covidien ECE Covidien ECE s.r.o. Technical service Galvaniho 7/a 821 04 Bratsilava Slovakia Tel+ Tel:4212 482 14573

Covidien Finland Oy Läkkisepäntie 23 00620 Helsinki Finland Tel. +35 896 226 84 10

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 Tel +33 (0) 810 787590

Covidien Hellas SA 8 Fragoklisias Street Maroussi, 151 25 Greece Tel +30 211 180 36 00

Covidien Hungary Covidien ECE s.r.o. Technical service Galvaniho 7/a 821 04 Bratsilava Slovakia Tel+ 421248214573

Covidien Ireland Commercial Ltd Block G, Ground Floor, Cherrywood Technology Park, Loughlinstown County Dublin Ireland

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

Covidien Italia S.p.A. Via Rivoltana 2/D 20090 Segrate Italy Tel +39 027 031 72 61

Covidien Japan Inc. Technical Support Center 83-1, Takashimadaira 1-Chome Itabashi-ku, Tokyo 175-0082 Japan Tel: +81 (0) 3 6859 0120

Covidien Mexico Insurgentes Sur No. 863 Piso 16 Col. Nápoles Del. Benito Juarez Mexico, D.F. 03810 Mexico Tel: (5255) 5804-1524

Covidien Nederland BV Hogeweg 105 5301 LL Zaltbommel Nederland Tel +31 41 857 66 68

Covidien Norge AS Postboks 343 1372 Asker. Norway Tel +47 668 522 22

Technical Support Contacts (Continued) Covidien Panama Parque Industrial Costa del Esta Calle Primera, Edifio # 109 Panama City, Panama Tel: (507) 264-7337

Covidien Polska COVIDIEN POLSKA SP.Z.O.O AL JEROZOLIMSKIE 181 WARSZAWA POLSKA 02-342 Tel:+48 2227 90405

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

Covidien Puerto Rico Palmas Industrial Park Road 869 Km 2.0 Bdlg. #1 Cataño, PR 00962 Tel. 787-993-7250 Ext. 7222 & 7221

Covidien Russia 53 bld. 5 Dubininskaya Street Moscow RUSSIA. 119054Tel +70 495 933 64 69

Covidien Saglik A.S. Maslak Mahallesi Bilim Sokak No: 5, Sun Plaza Kat: 2-3 Sisli, Istanbul 34398 Turkey [T] (+90) 212 366 20 00 [F] (+90) 212 276 35 25

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

Covidien Spain S.L. COVIDIEN SPAIN, S.L WORLD TRADE CENTER ALMEDA PARK PLAÇA DE LA PAU, S/N, EDIF 7-3ª PLANTA 08940 CORNELLA DE LLOBREGAT BARCELONA 8970 Tel 00 34 9347 58669

Covidien Sverige AB Box 54 171 74 Solna Sweden Tel +46 858 56 05 00

Covidien Switzerland Roosstr. 53 Wollerau 8832 Schweiz Tel +41 17865050

Covidien UK & Ireland Unit 2, Talisman Business Park London Road, Bicester OX26 6HR, United Kingdom Tel +44(0)1869 328092

Asia: Covidien Private Limited Singapore Regional Service Centre 15 Pioneer Hub, #06-04 Singapore 627753 Tel (65) 6578 5187 / 8 / 9 Tel (65) 6515 6578/5288 Email: [email protected]

Covidien USA 2101 Faraday Ave Carlsbad, CA 92008 Phone: 1-800-255-6774 (option 4) Email: [email protected]

Table of Contents 1 Safety Information 1.1 Overview... 1 1.2 Definitions... 1 1.3 Warnings... 1 1.4 Symbols, Labels and Markings... 4 2 General Introduction 2.1 Overview... 7 2.2 Indications for Use... 7 2.3 List of Components... 7 2.4 Power Pack Enclosure Views... 8 3 Installation 3.1 Overview... 11 3.2 Installation Instructions... 11 3.3 Installation of Power Pack into Carrying Bag... 11 3.4 Removable Battery Installation in Power Pack... 12 3.5 Power Pack Battery Charge Procedure... 13 3.6 Power Pack to Ventilator Connections... 14 3.7 Connecting the Dual Bag to the Carrying Bag... 16 3.8 Installation on a Wheelchair Using the Dual Bag... 16 3.9 Uninstalling Removable Battery... 17 3.10 Removable Battery Replacement... 17 4 Operation 4.1 Overview... 19 4.2 Battery Indicators... 19 4.3 Charging Battery Auto Test... 19 4.4 Charging the Power Pack Batteries... 19 4.5 When the Power Pack Battery Is Powering the Ventilator... 20 4.6 Battery Charge Indicator... 20 4.7 Low Battery Indicator... 20 4.8 Depleted Battery Indicator... 20 4.9 Temperature Indicator... 20 5 Maintenance 5.1 Overview... 21 5.2 Cleaning... 21 5.3 Preventive Maintenance... 22 5.4 Fuse Removal and Replacement... 23 6 Troubleshooting 6.1 Overview... 25 7 Parts and Accessories 7.1 Overview... 27 7.2 Replacement Parts... 27 User’s Manual

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8 Service 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10

Overview... 31 Warnings and ESD Control... 31 Tools and Equipment... 32 Internal Battery Replacement... 33 AC/DC Converter and Battery Charger Replacement... 35 Printed Circuit Board Assembly Replacement... 37 Main Housing Assembly Replacement... 40 Housing Cover and Battery Compartment Door Replacement... 41 Electrical Safety Test... 42 PB500 Series Battery Extraction Tab Installation... 43

9 Product Specifications 9.1 Overview... 45 9.2 Power Pack Electrical Characteristics... 45 9.3 Average Battery Operating Times... 45 9.4 Environmental Conditions... 46 9.5 Product Compliance... 46 9.6 Manufacturer’s Declaration... 47

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List of Tables Table 1-1. Symbol Descriptions... 4 Table 2-1. Typical Power Pack Carton Packing List... 7 Table 5-1. Operational Verification Checklist... 22 Table 6-1. Troubleshooting Guidelines... 25 Table 7-1. Consumables and Accessories... 29 Table 8-1. Tools and Equipment For Servicing the Power Pack... 32 Table 8-2. Electrical Safety Test Limits... 42 Table 9-1. Power Pack Electrical Characteristics... 45 Table 9-2. Average Times, Based on Ventilator Settings and Battery Type... 45 Table 9-3. Electromagnetic Emissions... 47 Table 9-4. Electromagnetic Immunity... 47 Table 9-5. Electromagnetic Immunity – Conducted and Radiated RF... 48 Table 9-6. Recommended Separation Distances... 49

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List of Figures Figure 2-1. Front Panel...8 Figure 2-2. Side Panel...8 Figure 2-3. Rear Panel...9 Figure 2-4. Ventilator Dual Bag and Power Pack Carrying Bag...9 Figure 3-1. Power Pack Installation...11 Figure 3-2. Battery Placement...12 Figure 3-3. AC Mains Connection...13 Figure 3-4. DC Power Cable Connector to Ventilator Connection...14 Figure 3-5. DC Power Cable Connection...15 Figure 3-6. Installing the Power Pack onto a Wheelchair...16 Figure 5-1. Fuse Replacement...23 Figure 7-1. Replacement Parts Exploded View...28 Figure 8-1. Enclosure Screw Removal...33 Figure 8-2. Internal Battery Orientation...34 Figure 8-3. Input and Output Cable Connectors...35 Figure 8-4. AC/DC Converter and Battery Charger Screws...36 Figure 8-5. PCBA Removal...37 Figure 8-6. Input and Output Cable Disconnection...38 Figure 8-7. J12 Connector Open...38 Figure 8-8. J12 Connector Closed...39 Figure 8-9. Main Assembly...40 Figure 8-10. Battery with Extraction Tab Attached...43 Figure 8-11. Battery Orientation Indicator...44

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Overview

1

Safety Information

1.1

Overview This chapter contains safety information requiring users to exercise appropriate caution while using the Puritan Bennett™ Power Pack with a Puritan Bennett™ 500 Series Ventilator.

1.2

Definitions This manual uses three indicators to highlight critical information. Warning Indicates a condition that can endanger the patient or equipment operator.

Caution Indicates a condition that can damage the equipment.

Note: Indicates points of particular emphasis for more efficient or convenient operation of the equipment.

Read, understand, and follow these instructions before using the Power Pack. In addition, to use the Power Pack correctly and efficiently and to help prevent incidents, review and adhere to all warnings and cautions contained in the Clinician’s or User’s Manual specific to the ventilator in use.

1.3

Warnings Fire hazard warnings

• Never expose batteries to direct flame. Warnings before using equipment

• Never use a Power Pack or any components or accessories that appear to be damaged. If any signs of damage are evident, contact your equipment supplier or Covidien.

Warnings regarding environment of use

• Do not operate in direct sunlight, near heat sources, outdoors, or near installations where liquid may pose a risk without first providing adequate protection for the device.

• To ensure correct and lasting operation of the device, install and operate the equipment in the environmental conditions/ranges recommended in this manual.

• Handle the Power Pack with care during and after use, particularly when ambient temperatures are high. Some Power Pack surfaces may become hot, even if safety specifications are not exceeded.

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• If the Power Pack 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, allow the Power Pack to stabilise in its operating environment for at least two (2) hours prior to use.

Warnings applicable during use of equipment

• To minimise the risk of damage, you must use the carrying bag to transport the Power Pack. • When the Power Pack is in use, ensure that the ventilator is connected to an alternative power source (such as AC or a fully charged internal battery) before disconnecting the Power Pack battery from the ventilator.

• Never immerse the device in any liquid or allow liquid to enter any device opening. Never place a container of liquid on top of the device. Immediately wipe away any liquid on the surface of the device.

• Although the Extra Long Life Li-Ion Battery (4.8 AH) meets current safety standards, it exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the Power Pack 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 Extra Long Life Li-Ion Battery is permitted as checkedin 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 the 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.

Warnings regarding electrical power

• Do not position the Power Pack in a way that makes it difficult to access the AC power cord or power cord connectors. The power cord serves as the means to disconnect the Power Pack from the AC input.

• Ensure the Power Pack battery, the Power Pack removable battery and the ventilator’s internal battery are fully charged before connecting the ventilator to the Power Pack.

• Powering the ventilator using the Power Pack DC cable only does not enable the ventilator's internal battery to recharge.

• When recharging the Power Pack batteries, the power supply to which the Power Pack is connected must comply with all applicable standards and provide electrical power corresponding to the AC voltage characteristics stated on the Power Pack label.

• To ensure 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.

• To avoid damage to the batteries or electrical components, prevent fluids from entering the device.

• Ensure that the AC and DC power cables are in perfect condition and not compressed. The device should not be turned on if the AC or DC power cable is damaged.

• 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.

• Connect the AC mains return cable by first connecting the cable to the ventilator and then to the Power Pack AC outlet port. Follow the reverse procedure to disconnect the device from the external DC power source. When connected to the AC mains supply, the Power Pack AC mains return cable is a live mains cable and should be treated as such. 2

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Warnings

• 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, within or removed from the Power Pack prior to its first use. Periodic recharging is important to help maximise useful life of the battery. Do not store the battery for extended periods, without recharging, as this may reduce the maximum life.

Warnings regarding hoses and accessories

• To ensure proper performance of the equipment, use only accessories approved and recommended by Covidien.

Warnings regarding maintenance

• Other than replacing the removable battery, do not attempt to open, repair or otherwise service the Power Pack. Doing so might endanger the patient, damage the battery, and/or void the warranty. Only personnel authorised and qualified by Covidien should repair, open, or service the Power Pack.

• Regularly clean the Power Pack device and carrying bag according to manufacturer’s recommendations.

• Use all cleaning solutions and products with caution, using only those solutions listed in this manual. Read and follow the instructions associated with the cleaning solutions used to clean the device.

Warnings to protect the environment

• The battery and the Power Pack should be considered as waste electrical and electronic equipment (WEEE). Dispose of battery and Power Pack in accordance with local requirements and regulations.

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1.4

Symbols, Labels and Markings Table 1-1. Symbol Descriptions

Symbols

Descriptions Caution, consult accompanying documents. Read, understand, and follow the User’s Manual instructions before using the Power Pack. DC power indicator on the ventilator. Alternating Current indicator. Charge indicator push button.

Internal battery charge indicator.

Removable battery charge indicator.

Temperature LED.

Serial number. IP3X: Protection rating against the intrusion of small foreign bodies into the device (without carrying bag). IPX2: Protection rating against water dripping or falling vertically when enclosure is tilted up to 15 degrees on either side of the vertical, as well as an environment featuring water vapour, condensation, or light rain (with device inside carrying bag). Canadian Standards Association (CSA). Signifies compliance with all applicable standards for the Canadian market. Manufacturer. Year of manufacture. WEEE (Waste Electrical and Electronic Equipment) symbol. This product must not be disposed of with household waste. Observe local ordinances for proper disposal. Air dry after cleaning. Machine wash up to 40ºC (104ºF) temperature water. Do not bleach. Do not iron. Do not dry clean.

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Symbols, Labels and Markings

Table 1-1. Symbol Descriptions (Continued) Symbols

Descriptions Temperature limitation.

Humidity limitation.

Atmospheric pressure limitation.

Electromagnetic symbol.

CE - Conformity European Signifies compliance with the medical device directive 2007/47/EC.

For prescription use only.

Label advising user to read the User’s Manual for information on how to insert the battery. See 3-2, Battery Placement, on page 12.

Insulation Class II Equipment (IEC 60417-5172).

Keep dry.

Operator must consult instructions for use.

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Overview

2

General Introduction

2.1

Overview This chapter contains general information about the Puritan Bennett™ Power Pack.

2.2

Indications for Use Intended Use The Puritan Bennett™ Power Pack provides an external battery which connects to the Puritan Bennett™ 500 Series Ventilators. It is an external DC power source.

Target Operators

• • • • •

Respiratory therapists Doctors Nurses Homecare providers Patient and patient’s families

Target Environments The Power Pack is suitable for use in institutional, home, and portable settings.

2.3

List of Components Table 2-1. Typical Power Pack Carton Packing List Quantity

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Item

1

Power Pack enclosure, including internal charger and battery

1

DC connection cable (25cm)

1

Carrying bag (blue or pink based on customer request)

1

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1

AC mains cable

1

AC mains return cable

7

2.4

Power Pack Enclosure Views Front Panel Figure 2-1. Front Panel

1 2 3 4 5 6

Keyboard Battery charge indicator LED, Internal Battery Battery charge indicator LED, Removable Battery Charge indicator push button AC power indicator Temperature LED

Side Panel Figure 2-2. Side Panel

1 2

8

Removable battery slot door Battery door latch

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Power Pack Enclosure Views

Rear Panel Figure 2-3. Rear Panel

1 2 3 4

DC connector AC mains cable retention AC mains output connector AC mains input connector

Front View Figure 2-4. Ventilator Dual Bag and Power Pack Carrying Bag

1 2

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Power Pack carrying bag Ventilator dual bag

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Overview

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Installation

3.1

Overview This chapter contains information for installing the Puritan Bennett™ Power Pack and connecting it to a Puritan Bennett™ 500 Series Ventilator.

3.2

Installation Instructions Warning Ensure the Power Pack battery, the Power Pack removable battery and the ventilator’s internal battery are fully charged before powering the ventilator from the Power Pack. Powering the ventilator using the Power Pack DC connection cable only does not enable the ventilator's internal battery to recharge.

If the Power Pack system is used without its carrying bag, set it down on a flat stable surface so that the shock absorber feet are all in contact with the surface. If not, it can also operate inside its carrying bag in any other position. Check that the surroundings do not hinder the different connections needed to run the apparatus, causing falls or jamming the cables connected to it.

3.3

Installation of Power Pack into Carrying Bag 1. Open the front panel of the carrying bag. 2. Slip the Power Pack into the carrying bag. 3. Secure the Velcro® strips to secure the Power Pack. 4. Check that the Power Pack is correctly inserted into the carrying bag and that the keyboard is clearly visible. Figure 3-1. Power Pack Installation

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