500 Series Ventilator Power Pack Users Manual Rev D

Technical Support Contacts Covidien Argentina

Covidien Australia

Covidien Austria GmbH

Aguero 351

52A Huntingwood Drive

Capital Federal - 1171 ABC, Argentina

Huntingwood, NSW 2148

Tel: (5411) 4863-5300

Campus21 Europaring F09402 Brunn am Gebrige A-2345 Österreich

Telephone (+61) 1800 350702

Fax: (5411) 4863-4142

Fax +612 9671 8118

+43 223 637 88 39 +43 223 637 88 39 40

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

Covidien Brazil

Covidien Canada

Av. Nações Undias 23013-A

19600 Clark Graham

Vila Almeida

Baie d'Urfe, QC, H9X 3R8

São Paulo, SP

Canada

Tel +32 152 981 37

Brasil 04795-100

Tel:1-514-695-1220, Ext.4004

Fax +32 152 167 83

Tel: (5511) 5683-8300

Fax: 1-514-695-4965

Australia

Fax: (5511) 5683-8349 Covidien Chile

Covidien Colombia

Covidien Costa Rica

Rosario Norte 530, Piso 12

Edificio Prados de la Morea

Las Condes

Carretera Central Del Norte

La Uruca 75 Metros al Oseste de Faco

Santiago de Chile, Chile

(Cra 7a)Kilometro 18,

Oficentro La Virgen, Edificio "I"

Tel: (562) 231-3411

Chia-Cundinamarca

San Jose, Costa Rica

Fax: (562) 231-3527

Bogota, Colombia

Tel: (506) 256-1170

Tel: (571) 619-5469

Fax: (506) 256-1185

Fax: (571) 619-5425

Fax: (506) 290-8173

Covidien Czech Republic

Covidien Danmark A/S

Covidien Deutschland GmbH

Vyskocilova 1410/1

Langebrogade 6E, 4. sal

Technisches Service Center

140 00

1411 København K

Raffineriestr. 18

Praha

Danmark

93333 Neustadt / Donau

Ceska Republika

Tel +45 702 753 50

Germany

Tel +42 024 109 57 35

Fax:+45 702 756 50

Tel + 49 944 595 93 80 Fax + 49 944 595 93 65

Fax + 42 02 3900 0437 Covidien ECE

Covidien Finland Oy

Covidien France SA

Galvaniho 7/a

Läkkisepäntie 23

Parc d’affaires Technopolis

821 04 Bratislava

00620 Helsinki

Slovenska Republika

Finland

Bat. Sigma, 3 Avenue du Canada

Tel +42 124 821 45 73

Te. +35 896 226 84 10

LP 851 Les Ulis

Fax +42 124 821 45 01

Fax +35 896 226 84 11

91975 Courtaboeuf Cedex France Tel +33 169 821 400 Fax +33 169 821 532

Covidien Hellas SA

Covidien Hungary

8 Fragoklisias Street

1095 Budapest

Covidien Ireland Commercial Ltd

Maroussi, 151 25

Mariassy u. 7

Block G, Ground Floor,

Greece

Magyarorszag

Cherrywood Technology Park,

Tel +30 211 180 36 00

Hungary

Loughlinstown

Fax +30 210 614 63 80

Tel + 36 1880 7975

County Dublin

Fax + 36 1777 4932

Ireland Tel +353 1 4381613

Technical Support Contacts (Continued) Covidien Israel

Covidien Italia S.p.A.

Covidien Japan Inc.

5 Shacham St. North Industrial Park Caesarea 38900 Israel

Via Rivoltana 2/D

Technical Support Center

20090 Segrate

83-1, Takashimadaira 1-Chome

Italy Tel +39 027 031 72 61

Itabashi-ku, Tokyo 175-0082 Japan

Fax +39 027 031 72 84

Tel: +81 (0) 3 6859 0120

Tel +97 246 277 388 Fax+97 266 277 688

Fax: +81 (0) 3 6859 0142 Covidien Mexico

Covidien Nederland BV

Covidien Norge AS

Calz.Ermita Iztapalapa 1514

Hogeweg 105

Postboks 343

Col. Barrio San Miguel

5301 LL Zaltbommel

1372 Asker.

Del. Iztapalapa

Nederland

Norway

Mexico, D.F. 09360 Mexico

Tel +31 41 857 66 68

Tel +47 668 522 22

Tel: (5255) 5804-1524

Fax +31 41 857 67 96

Fax +47 668 522 23

Covidien Panama

Covidien Polska

Covidien Portugal Lda.

Parque Industrial Costa del Esta

Al. Jerozolimskie 162 Warszawa. 02-342 Polska

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

Tel +48 223 122 130

Portugal

Fax +48 223 122 020

Tel +35 121 448 10 36

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 +35 121 445 1082 Covidien Puerto Rico

Covidien Russia

Covidien Saglik A.S.

Palmas Industrial Park

53 bld. 5 Dubininskaya Street Moscow

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

RUSSIA. 119054Tel +70 495 933 64 69 Fax +70 495 933 64 68

Sisli, Istanbul 34398

Road 869 Km 2.0 Bdlg. #1 Cataño, PR 00962 Tel. 787-993-7250

Turkey

Ext. 7222 & 7221

Tel +90 212 366 20 00

Fax 787-993-7234

Fax +90 212 276 35 25

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

c/Fructuós Gelabert

Box 54

6, pl. Sótano

171 74 Solna

08970 Sant Joan Despí

Sweden

Barcelona, Spain

Tel +46 858 56 05 00

Tel +34 93 475 86 69

Fax + 46 858 56 05 29

Fax +34 93 373 87 10

Technical Support Contacts (Continued) Covidien Switzerland

Covidien UK & Ireland

Asia: Tyco Healthcare Pte Ltd

Roosstr. 53

Unit 2, Talisman Business Park

Wollerau 8832 Schweiz

London Road, Bicester

Singapore Regional Service Centre

OX26 6HR, United Kingdom

15 Pioneer Hub, #06-04

Tel +44(0)1869 328092

Singapore 627753

Fax +44(0)1869 327585

Tel (65) 6578 5187 / 8 / 9

Tel +41 17865050 Fax +41 17865010

Fax (65)6515 5260. Email: [email protected]

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

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Table of Contents

1 Safety Information ... 1 1.1 1.2 1.3 1.4

Overview... 1 - 1 Definitions... 1 - 1 Warnings... 1 - 1 Symbols, Labels and Markings... 1 - 4

2 General Introduction ... 7 2.1 2.2 2.3 2.4

Overview... 2 - 7 Indications for Use... 2 - 7 List of Components... 2 - 7 Power Pack Enclosure Views... 2 - 8

3 Installation ... 11 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10

Overview... 3 - 11 Installation Instructions... 3 - 11 Installation of Power Pack into Carrying Bag... 3 - 11 Battery Installation in Power Pack... 3 - 11 Power Pack Battery Charge Procedure... 3 - 12 Power Pack to Ventilator Connection... 3 - 12 Connecting the Dual Bag to the Carrying Bag... 3 - 14 Installation on a Wheelchair Using the Dual Bag... 3 - 14 Battery Removal... 3 - 15 Battery Replacement... 3 - 15

4 Operation ... 17 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10

Overview... 4 - 17 Battery Indicators... 4 - 17 Charging Battery Auto Test... 4 - 17 Charging the Power Pack Battery with the External Charger. 4 - 17 When the Power Pack is Powering the Ventilator... 4 - 17 Battery Charge Indicator... 4 - 17 Low Battery Indicator... 4 - 17 Depleted Battery Indicator... 4 - 18 Temperature Indicator... 4 - 18 External Battery Charger LED... 4 - 18

5 Preventive Maintenance ... 19 5.1 5.2 5.3

Overview... 5 - 19 Maintenance... 5 - 19 Periodic Safety Checks... 5 - 20

6 Parts and Accessories ... 21 6.1 6.2 User’s Manual

Overview... 6 - 21 Replacement Parts... 6 - 21 i

7 Product Specifications ... 23 7.1 7.2 7.3 7.4 7.5 7.6 7.7

ii

Overview... 7 - 23 External Charger Electrical Characteristics... 7 - 23 Power Pack Electrical Characteristics... 7 - 23 Average Battery Operating Times... 7 - 23 Environmental Conditions... 7 - 24 Product Compliance... 7 - 24 Manufacturer’s Declaration... 7 - 24

User’s Manual

Overview

1

Safety Information

1.1

Overview This section 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 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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1

• 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.

• The Long Life Li-Ion Battery (2.4AH) meets current safety standards, and although lithium batteries are considered to be Dangerous Goods for transport in commerce, this battery is below the 100Wh threshold and is therefore excepted from being a Class 9 – Miscellaneous - Dangerous Goods (DG). However, the Long Life Li-Ion Battery is 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, two spare Long Life Li-Ion batteries per person may be taken on board as carry-on luggage only. 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.

• 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

• Ensure the power pack battery, the power pack spare 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 does not enable its internal battery to recharge. • When recharging the power pack batteries, the power supply to which the external charger is connected must comply with all applicable standards and provide electrical power corresponding to the AC voltage characteristics stated on the external charger 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.

2

User’s Manual

Warnings

• 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.

• 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 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 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. 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. Charge indicator push button.

Battery charge indicator. Temperature LED.

Serial number. Index of Protection rating indicates protection against the intrusion of small foreign bodies into the device and protection against water dripping or falling vertically, as well as an environment featuring water vapour condensation and/or light rain. (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. Temperature limitation.

Humidity limitation.

Atmospheric pressure limitation.

4

User’s Manual

Symbols, Labels and Markings

Table 1. Symbol Descriptions (Continued) Symbols

Descriptions DC power input connector that connects the battery charger output to the power pack. DC power output connector that connects the power pack to the DC connector of the Puritan Bennett™ 500 Series ventilator via the DC connection cable. 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 batttery. See Figure 2, Battery Placement, on page 12.

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6

User’s Manual

Overview

2

General Introduction

2.1

Overview This section 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 1. Typical Power Pack Carton Packing List Quantity

User’s Manual

Item

1

Power pack enclosure

1

DC connection cable (25cm)

1

External charger and AC cable

1

Carrying bag (blue or pink based on customer request)

1

Puritan Bennett™ Power Pack User’s Manual

1

Long lasting or extra long lasting battery (based on customer request)

7

2.4

Power Pack Enclosure Views Front Panel Figure 2. Front Panel

1 2 3 4

Control panel Charge indicator push button Battery charge indicator LED Temperature LED

Side Panel Figure 3. Side Panel

1 2 3

8

Spare Battery Storage Slot Active Battery Slot Door Battery Door Latch

User’s Manual

Power Pack Enclosure Views

Rear Panel Figure 4. Rear Panel

1 2

DC connector port DC connector cable

Front View Figure 5. Ventilator dual bag and power pack carrying bag

1 2

User’s Manual

Power pack carrying bag Ventilator dual bag

9

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User’s Manual

Overview

3

Installation

3.1

Overview This section 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 spare 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 does not enable its internal battery to recharge.

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 1. Power Pack Installation

3.4

Battery Installation in Power Pack To install the battery in the power pack enclosure: 1. Place the battery on a level, dry surface. 2. Open the door latch of the active battery compartment. 3. Position the battery to match the orientation shown on the label inside the door latch. 4. Slide the supplemental battery into the active battery compartment and snap gently into place.

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5. Close the door latch of the active battery compartment. 6. Click the latch to the right to ensure it is securely fastened. 7. Check that the power pack is correctly inserted into the carrying bag and that the keyboard is clearly visible. 8. Charge the battery shipped with the power pack enclosure. See “Power Pack Battery Charge Procedure” on page 12. Figure 2. Battery Placement

3.5

1

Spare battery compartment

2

Spare battery (optional)

3

Battery in use

Power Pack Battery Charge Procedure To charge the power pack battery: 1. Line up the marker dot on the connector of the external charger’s DC power cable with the dot on the DC connector on the rear of the power pack enclosure. 2. Push the DC power cable onto the power pack enclosure connector until an audible click occurs. The click indicates the connectors are locked together. 3. Plug the female connector on the AC power cable included with the charger into the socket on the charger. 4. Connect the other end of the AC power cable to a main power outlet.

3.6

Power Pack to Ventilator Connection Warning Ensure the power pack battery, the power pack spare battery and the ventilator’s internal battery are fully charged before connecting the ventilator to the power pack. 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.

12

User’s Manual

Power Pack to Ventilator Connection

To connect the power pack to the ventilator: 1. Line up the red marker dot on the DC connector on the rear of the power pack with the marker on the smaller connector on the power pack cable. See Figure 4, Rear Panel, on page 9. 2. Push the DC power cable onto the power pack’s DC power connector until an audible click occurs. The click indicates the connectors are locked together. 3. Line up the red marker dot on the ventilator’s DC power connector with the marker on the larger connector on the power pack cable. See Figure 3 below. Figure 3. Larger DC Power Cable Connector to Ventilator Connection

1 Red dots, aligned 2 DC power cable

4. Push the DC power cable onto the ventilator’s DC power connector until an audible click occurs. The click indicates the connectors are locked together. With the proper connection of all cables, the DC POWER corner of the ventilator illuminates.

indicator on the top left

To disconnect the DC power cable from the power pack and the ventilator: 1. Grasp the DC power cable on the ventilator. 2. Slide the locking ring back. 3. Pull the plug away from the ventilator’s rear panel to disengage it. 4. A “DC POWER DISCONNECTION“ alarm signals an automatic switch to the ventilator internal battery. 5. Grasp the DC power cable on the power pack. 6. Slide the locking ring back. 7. Pull the plug away from the power pack’s rear panel to disengage it. 8. Place the cable in a safe location for future use.

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