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Battery Support System 2 Operating Instructions

User guide 28 pagine · 785.98 KB · PDF

BATTERY SUPPORT SYSTEM 2

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OPERATING INSTRUCTIONS

BATTERY SUPPORT SYSTEM 2

IMPORTANT

Federal (USA) law restricts this device to sale by or on the order of a physician. This instrument is to be used by authorized personnel only.

Device Tracking

(USA only, including US government-owned units) The Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. If your defibrillator has been sold, donated, lost, stolen, exported, or destroyed or if it was not obtained directly from Medtronic Physio-Control Corp., please notify Physio at 1.800.442.1142, extension 4530.

Responsibility for Information

It is the responsibility of our customers to ensure that the appropriate person(s) within their organization have access to this information, including general safety information provided in Section 1.

Medtronic Physio-Control

11811 Willows Road Northeast

Post Office Box 97006

Redmond, WA 98073-9706 USA

Telephone: 425.867.4000

Toll Free (USA only): 800.442.1142

Fax: 425.867.4121

Internet: www.physiocontrol.com

www.medtronic.com

European Union Contact

Medtronic Physio-Control UK Ltd.

Leamington Court

Andover Road, Newfound

Basingstoke, Hampshire

RG23 7HE United Kingdom

Telephone: 44.1256.782.727

Fax: 44.1256.782.728

TABLE OF CONTENTS

1 Safety Information
Terms.....1-2
General Warnings and Cautions.....1-2
Symbols and Abbreviations.....1-3
Document Conventions.....1-4
2 Basic Orientation
PHYSIO-CONTROL Battery Support System 2.....2-2
The FASTPAK and LIFEPAK Family of Batteries.....2-2
Unpacking and Inspecting.....2-3
Controls, Indicators, and Connectors.....2-3
Inserting Batteries.....2-4
3 Battery Maintenance
Battery Maintenance Warning.....3-2
Battery Maintenance Guidelines and Procedures.....3-2
Receiving New Batteries.....3-4
Storing Batteries.....3-4
Discarding/Recycling Batteries.....3-4
4 BSS 2 Maintenance
The BSS 2 Service Indicator.....4-2
Cleaning.....4-2
Fuse Replacement.....4-2
Troubleshooting.....4-3
Replacement Parts and Accessories.....4-4
Specifications.....4-4
Warranty Policy.....4-6
Product Recycling Information.....4-6

LIST OF FIGURES

Figure 2-1 Physio-Control FASTPAK and LIFEPAK batteries ..... 2-2
Figure 2-2 Controls, indicators, and connectors ..... 2-3
Figure 2-3 Battery fuel gauge ..... 2-4

LIST OF TABLES

Table 2-1 Controls, indicators, and connectors.....2-3
Table 4-1 Troubleshooting tips for the BSS 2.....4-3
Table 4-2 Replacement Parts and Accessories.....4-4
Table 4-3 BSS 2 specifications.....4-4
Table 4-4 FASTPAK and LIFEPAK Battery Specifications.....4-5

CEDECLARATION OF CONFORMITY according to ISO/IEC Guide 22 and EN 45014
Manufacturer's Name:Medtronic Physio-Control Corp.
Manufacturer's Address:11811 Willows Road NE P.O. Box 97006 Redmond, WA 98073-9706 USA
declares that the CE-marked product
Product Name:Battery Support System 2
Model Number(s):3010035
complies with 93/42/EEC (Medical Device Directive) class I, conformity assessed per Annex 7.
This product complies with:
Safety:EN 61010 PT1 1993 amd. 1995- Class I - Pollution degree 2 - Installation Category II
EMC:EN 55011: 1991 amd. 1997 Susceptibility (CISPR 11)- Group 1, Class B EN 61000 PT4-2: 1995 ESD- 6 kV CD, 8 kV AD EN 61000 PT4-3: 1996 Radiated Immunity - 3 V/m EN 61000 PT4-4: 1996 Transient/Burst - 0.5 kV Signal lines - 1 kV Power lines
Redmond, February 14, 1998

Redmond, February 14, 1998

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dỆhiij

Michael D. Willingham

Vice President of Quality and Regulatory Affairs

European Contact: Your local Medtronic Physio-Control Sales and Service Office or Leamington Court, Andover Rd, Newfound, Basingstoke, Hampshire RG23 7HE UK.

SAFETY INFORMATION

This section provides important information to help you safely operate the PHYSIO-CONTROL $ ^{\circledR} $ Battery Support System 2. Familiarize yourself with all of these terms, warnings, and symbols.

Termspage 1-2
General Warnings and Cautions1-2
Symbols and Abbreviations1-3
Document Conventions1-4

TERMS

The following terms are used either in these operating instructions or on the Battery Support System 2 (BSS 2):

Danger: Immediate hazards that will result in serious personal injury or death.

Warning: Hazards or unsafe practices that could result in serious personal injury or death.

Caution: Hazards or unsafe practices that could result in minor personal injury, product damage, or property damage.

GENERAL WARNINGS AND CAUTIONS

The following are general warning and caution statements. Other specific warnings and cautions are provided as needed in other sections of these operating instructions.

WARNINGS!

Shock or fire hazard.

Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on the device or accessories. Do not clean with alcohol, ketones, or other flammable agents. Do not autoclave or sterilize this device unless otherwise specified.

Possible fire or explosion.

Do not use this device in the presence of flammable gases or anesthetics. Place the BSS 2 in the proper

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