PHYSIO CONTROL Battery Support System 2 Operating Instructions part number 3010515-000

OPERATING INSTRUCTIONS

BATTERY SUPPORT SYSTEM 2

Important Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Tracking (USA only, including US government-owned units) Under the Safe Medical Devices Act of 1990, defibrillator manufacturers and distributors are required to track the location of defibrillators. If your defibrillator has been sold, donated, lost, stolen, exported, or destroyed, or if it was not obtained directly from Physio-Control Corporation, please notify PhysioControl Corporation 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 information provided in the Safety Information section.

Corporate Headquarters 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

PHYSIO-CONTROL, LIFEPAK, and FASTPAK are registered trademarks of Physio-Control Corporation. PARTSLINE is a trademark of Physio-Control Corporation. Specifications and prices subject to change without notice. Litho in USA. ©February 1998 Physio-Control Corporation. P/N 3010515-000

European Union Contact 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

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Bat teySuportSystem2Opera tnigInsuctr tions

Table of Contents

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... 4-5 Product Recycling Information ... 4-6

Battery Support System 2 Operating Instructions

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List of Figures

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 SLA Battery Specifications... 4-5

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Battery Support System 2 Operating Instructions

DECLARATION OF CONFORMITY according to ISO/IEC Guide 22 and EN 45014 Manufacturer’s Name: Manufacturer’s Address:

Physio-Control Corporation

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 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) EN 61000 PT4-2: 1995 ESD EN 61000 PT4-3: 1996 Radiated Immunity EN 61000 PT4-4: 1996 Transient/Burst

− Group 1, Class B − 6 kV CD, 8 kV AD − 3 V/m − 0.5 kV Signal lines − 1 kV Power lines

Redmond, February 14, 1998

_____________________________________________

Michael D. Willingham Vice President of Quality and Regulatory Affairs

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

Battery Support System 2 Operating Instructions

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1

SAFETY INFORMATION

This section provides important information to help you safely operate the PHYSIO-CONTROL® Battery Support System 2. Familiarize yourself with all of these terms, warnings, and symbols. Terms General Warnings and Cautions Symbols and Abbreviations Document Conventions

Battery Support System 2 Operating Instructions

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Safety Information

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 location as specified in these operating instructions. Possible fire or explosion.

The BSS 2 is designed to be used with Physio-Control batteries only. Other manufacturers’ batteries may overheat in this battery support system. Do not use with remanufactured or alternate source batteries. Possible loss of power during patient care.

Physio-Control has no information regarding the performance or effectiveness of its LIFEPAK® defibrillator/monitors if they are used with other manufacturers’ batteries or battery chargers. Using other manufacturers’ batteries or battery chargers may result in device failure and may void warranty. Use only Physio-Control batteries and the appropriate PHYSIO-CONTROL Battery Support System.

CAUTIONS! Possible equipment damage.

This device may be damaged by mechanical or physical abuse such as immersion in water or dropping. If the device has been abused, remove it from use and contact a qualified service technician. Possible or potential inaccurate battery charge level indicator.

Using the PHYSIO-CONTROL Battery Support System (P/N 801807) or the two-well Battery Charger (P/Ns 9-00284, 9-00288, and 801530) to charge and maintain a FASTPAK ® 2 battery will eventually result in an inaccurate battery charge level indicator. Use only the BSS 2 (P/N 3010035) to charge and maintain FASTPAK 2 batteries. Possible equipment damage.

The supplied power cord is used to connect the battery support system to ac line voltage. Excessive voltage may cause fuses in the BSS 2 to blow. Before connecting the battery support system, ensure that you are using a grounded outlet of the correct voltage. Note: The BSS 2 has no ON/OFF switch. When connecting the BSS 2 to ac line voltage, make sure

that the power cord is easily accessible and is not obstructed in any way. In case of device malfunction or overheating, disconnect the device from the ac line voltage by removing the power cord. 1-2

Battery Support System 2 Operating Instructions

Safety Information

SYMBOLS AND ABBREVIATIONS The symbols and abbreviations below may be found in these operating instructions, on the BSS 2, or on FASTPAK and LIFEPAK SLA batteries: Attention, consult accompanying documents

C

RC RB

RB R

Recycle NiCd battery Ni-Cd

Recycle PB battery

or

Recycle this product

Rechargeable battery: recycle battery Direct Current (DC) Alternating Current (AC) Positive terminal Negative terminal

Fuse Type B, isolation (no patient connection) Indoor use only

LOT YYWW YYYY

NRTL/C

Manufacturing date (batteries) Manufacturing date (BSS 2)

Canadian Standards Association certification for United States (Nationally Recognized Test Laboratory) and Canada European Economic Community mark of conformity to one or more European norms or directives, as indicated in the Declaration of Conformity

Hz

Hertz (frequency)

V

Volts

A

Amps

W

Watts

Battery Support System 2 Operating Instructions

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Safety Information

T

Slow Blow fuse

LED

Light Emitting Diode

NiCd

Nickel Cadmium chemistry battery

P/N

Part Number

S/N

Serial Number

SLA

Sealed Lead Acid chemistry battery

DOCUMENT CONVENTIONS Text references to device buttons and labels are indicated in capital letters, for example: CHARGE.

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Battery Support System 2 Operating Instructions

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BASIC ORIENTATION

This section provides a basic orientation to the PHYSIO-CONTROL® Battery Support System 2. PHYSIO-CONTROL Battery Support System 2 The FASTPAK and LIFEPAK Family of Batteries Unpacking and Inspecting Controls, Indicators, and Connectors Inserting Batteries

Battery Support System 2 Operating Instructions

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Basic Orientation

PHYSIO-CONTROL BATTERY SUPPORT SYSTEM 2 The PHYSIO-CONTROL Battery Support System 2 (BSS 2) provides charging, conditioning, and shelf life testing for the complete family of Physio-Control FASTPAK and LIFEPAK SLA batteries. The BSS 2: • Provides a clear indication that a battery is charging, ready for use, or needs to be discarded. • Can charge, condition, or shelf life test up to three FASTPAK and LIFEPAK SLA batteries at one time. • Is provided with a detachable power cord that connects to a grounded ac outlet. • Has a wall mount bracket (optional) that permits horizontal or vertical mounting.

THE FASTPAK AND LIFEPAK FAMILY OF BATTERIES WARNING! Possible explosion.

Attempting to charge a LIFEPAK 5 battery in the BSS 2 may cause the battery to explode. Do not charge LIFEPAK 5 batteries in the BSS 2.

The batteries shown in Figure 2-1 can be used in the LIFEPAK® 12 defibrillator/monitor series and, except for the LIFEPAK SLA, can be used with other LIFEPAK defibrillator/monitors. The LIFEPAK SLA battery can only be used in the LIFEPAK 12 defibrillator/monitor.

FASTPAK 2 battery P/N 3009375

FASTPAK battery P/N 9-10424-19 (gold) P/N 9-10424-18 (white)

LIFEPAK SLA battery P/N 3009378

Figure 2-1 Physio-Control FASTPAK and LIFEPAK batteries

FASTPAK and FASTPAK 2 batteries have a nickel cadmium (NiCd) chemistry and LIFEPAK SLA batteries have a sealed lead acid (SLA) chemistry. In addition, the FASTPAK 2 battery has a charge level indicator (fuel gauge). Charge FASTPAK batteries in either the Battery Support System (BSS) (P/N 801807), the Battery Support System 2 (BSS 2) (P/N 3010035), or the LIFEPAK 12 defibrillator when it is powered by the AC or DC Power Adapter. FASTPAK batteries require periodic conditioning and shelf life testing to optimize performance. Condition and shelf life test FASTPAK batteries in the BSS or BSS 2. Charge the FASTPAK 2 battery in the BSS 2 or in the LIFEPAK 12 defibrillator when it is powered by the AC or DC Power Adapter. Using the BSS (P/N 801807) or the two-well Battery Charger (P/Ns 9-00284, 9-00288, and 801530) to charge and maintain a FASTPAK 2 battery will eventually result in an inaccurate battery charge level indicator. FASTPAK 2 batteries require periodic conditioning and shelf life testing to optimize performance. Condition and shelf life test FASTPAK 2 batteries only in the BSS 2. Charge SLA batteries either in the BSS 2 or in the LIFEPAK 12 defibrillator when it is powered by the AC or DC Power Adapter. Periodic conditioning and shelf life testing may optimize SLA battery performance. Condition and shelf life test LIFEPAK SLA batteries in the BSS 2.

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Battery Support System 2 Operating Instructions

Basic Orientation

UNPACKING AND INSPECTING Remove the BSS 2, ac power cord, and product literature from the shipping container. Carefully inspect the BSS 2 and the power cord for any signs of damage during shipping. Verify the receipt of everything noted in the packing list. Save the shipping container and the foam inserts in case the BSS 2 needs to be returned.

CONTROLS, INDICATORS, AND CONNECTORS Figure 2-2, Figure 2-3, and Table 2-1 provide an overview of the controls, indicators, and connectors for the BSS 2 and FASTPAK 2 batteries.

9

12

8 10, 11

7 6

5 4 1

3 2 Figure 2-2 Controls, indicators, and connectors

Table 2-1 Controls, indicators, and connectors

1

SERVICE

Indicates BSS 2 needs service.

2

POWER

Indicates power is on.

3

SHELF LIFE

Amber LED indicates battery is undergoing a shelf life test.

4

CONDITION

Amber LED indicates battery is conditioning.

5

CHARGE

Amber LED indicates battery is charging.

6

DISCARD

Indicates battery should be removed from use and discarded/ recycled.

7

READY

Indicates battery is ready for use.

8

+ /– Terminals

Transfer charge current onto battery.

Battery Support System 2 Operating Instructions

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Basic Orientation

9

Communication Pins

Provide digital communication between the BSS 2 and the battery.

10

AC Power Input Receptacle

Receptacle for ac power cord.

11

Fuses

Two fuses help protect the BSS 2 from current surges.

12

Power Cord

Cable for operation from an ac outlet.

14

13

Figure 2-3 Battery fuel gauge

13

Fuel Gauge Button

14

Fuel Gauge Indicators

Lights the fuel gauge indicators. One to four lights indicate the relative charge of the battery, with four lights indicating maximum charge. One light flashing: charge battery. Two alternately flashing lights: battery requires conditioning. No lights: battery has 0% charge or needs to be discarded.

INSERTING BATTERIES CAUTION! Failure to charge batteries.

Battery pins in the battery support system may be damaged if the batteries are dropped or forced into the battery wells. Inspect the battery pins routinely for signs of damage.

Routinely inspect batteries for damage or leakage. Discard/recycle damaged or leaking batteries. To insert a battery into a battery well: 1 2 3 4 5

Inspect the +/- terminals (pins) in the battery well for signs of damage. Inspect the battery well for signs of damage or distortion. Align the battery so that the battery clip is over the pins in the battery well. Insert the end of the battery opposite the battery clip into the battery well. Firmly press the other end into the battery well until it clicks into place.

To remove the battery, press the battery clip in and lift the battery out of the battery well.

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Battery Support System 2 Operating Instructions

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BATTERY MAINTENANCE

This section describes how to use the PHYSIO-CONTROL Battery Support System 2 to maintain FASTPAK and LIFEPAK SLA batteries. Battery Maintenance Warning Battery Maintenance Guidelines and Procedures Receiving New Batteries Storing Batteries Discarding/Recycling Batteries

Battery Support System 2 Operating Instructions

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Battery Maintenance

BATTERY MAINTENANCE WARNING WARNING! Possible loss of power and delay of therapy during patient care.

Using an improperly maintained battery to power the defibrillator may cause power failure without warning. Use the appropriate PHYSIO-CONTROL Battery Support System to charge and condition batteries.

BATTERY MAINTENANCE GUIDELINES AND PROCEDURES To maximize BSS 2 operation and battery performance and life, observe these guidelines: • Place the BSS 2 in the proper location • Charge batteries at room temperature • Rotate batteries • Condition batteries every three months • Perform shelf life tests every six months (optional for LIFEPAK SLA)

Place the BSS 2 in the Proper Location To help ensure proper BSS 2 functioning: • Place in a dry, well-ventilated area • Keep at room temperature • Keep batteries in wells • Do not place in direct sunlight • Do not place near a heat source or an air conditioner • Keep fan vent on back panel unobstructed

Charge Batteries at Room Temperature Charging batteries at room temperature, 20°C to 25°C (68°F to 78°F), is preferred to maximize battery performance and life. The extreme temperature range for charging batteries is 5°C to 35°C (41°F to 95°F). Batteries charged outside this temperature range may not reach a full charge (even if charging time is increased) and irreversible cell damage could occur. CAUTION! Possible battery damage.

Charging a battery at temperatures below 5°C (41°F) or above 35°C (95°F) prevents the battery from reaching full capacity and may cause irreversible cell damage.

Fully charge SLA batteries between uses. If SLA batteries are not 100% recharged between uses, sulfation (lead sulfate buildup on electrode surfaces inside the battery) can occur. Sulfation reduces battery capacity and may result in premature battery failure. To charge a battery: 1 Insert a battery into a BSS 2 battery well. CHARGE LED lights and charging begins automatically. 2 READY lights when a battery reaches full charge. The battery may remain in the battery well until needed. The BSS 2 supplies a trickle charge that prevents overcharging and maintains the battery at peak capacity. Note: CONDITION LED lights and the conditioning procedure begins automatically if aFASTPAK 2 or LIFEPAK SLA battery requires conditioning. Note: Withdrawal of the battery from the charger prior to a READY indication may result in inadequate charge. Note: If DISCARD lights, remove the battery from use and discard/recycle (see page 3-4). 3-2

Battery Support System 2 Operating Instructions

Battery Maintenance

Rotate Batteries Rotate all batteries in active use so that they are used with equal frequency.

Condition Batteries Every Three Months Voltage depression is a condition that reduces battery performance. When NiCd batteries repeatedly receive a shallow discharge (that is, not allowed to drain completely between charging cycles), voltage depression occurs. This condition is often mistakenly called “memory.” Voltage depression can usually be reversed by conditioning the battery every three months. Conditioning is a series of charge/deep discharge cycles performed in the BSS 2 to measure and optimize battery capacity. To condition a battery: 1 Insert the battery into any battery well. CONDITION LED lights automatically when a FASTPAK 2 or LIFEPAK SLA battery requires conditioning. Allow the FASTPAK 2 or the LIFEPAK SLA battery to complete the condition cycle. 2 Press CONDITION for other FASTPAK batteries. 3 READY lights when a battery is fully recharged. The BSS 2 automatically recharges a battery that passes the conditioning process. Note: If DISCARD lights, remove the battery from use and discard/recycle. Note: If a power failure occurs during battery conditioning, the BSS 2 interrupts conditioning and

reverts to CHARGE mode once power is restored. Battery conditioning may not have been completed. Repeat conditioning process.

Perform Shelf Life Testing Every Six Months Batteries self-discharge when not in use. A new NiCd battery self-discharges approximately 1% of its capacity every day when stored at room temperature. In 10 days, a new NiCd battery loses approximately 10% of its capacity. SLA batteries have a low self-discharge rate. A new SLA battery self-discharges approximately 0.1% of its capacity each day when stored at room temperature. In 10 days, a new SLA battery loses approximately 1.0% of its capacity. The actual rate of battery self-discharge depends on: • Battery age • Temperature • Frequency of use • Length of time in storage • Physical condition These factors can combine to significantly increase the battery discharge rate. For example, an older NiCd battery stored at higher temperatures may have an accelerated self-discharge rate much greater than 1% a day. The self-discharge rate increases as the battery ages. The shelf life test evaluates the self-discharge rate of a battery. Any battery that fails the shelf life test (DISCARD lights) should be removed from use and discarded/recycled. To perform a shelf life test: 1 2 3 4

Complete the conditioning procedure. Remove the battery from the BSS 2 and store for 7 days at room temperature. After storage, insert the battery into a battery well and press SHELF LIFE within 3 seconds. Verify that SHELF LIFE LED lights.

Battery Support System 2 Operating Instructions

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Battery Maintenance

5

READY lights when the battery passes the shelf life test and is fully recharged. The battery may then be returned to use.

Note: If DISCARD lights, remove the battery from use and discard/recycle. Note: If a power failure occurs during shelf life test, the BSS 2 interrupts the shelf life test and reverts

to CHARGE mode once power is restored. Shelf life test may not have been completed. Repeat the shelf life test.

RECEIVING NEW BATTERIES When newly-purchased batteries are received, charge each new battery. Because batteries selfdischarge during storage, a new battery may not be fully charged when it is received.

STORING BATTERIES WARNING! Possible loss of power during patient care.

Stored batteries lose charge. Failure to charge a stored battery before use may cause device power failure without warning. Always charge a stored battery before placing it in active use.

Store batteries in or out of the BSS 2 except when performing the shelf life test. During storage, batteries still require routine maintenance (refer to the conditioning procedure, page 3-3, and the shelf life test, page 3-3). Storing an SLA battery that is less than 100% charged can result in permanent damage. When storing batteries: • Fully charge LIFEPAK SLA batteries before storing. • Store batteries between 4.4°C and 26.7°C (40°F to 80°F). Lower temperatures reduce the battery self-discharge rate. Higher temperatures increase the self-discharge rate. • Do not freeze batteries. Damage to the battery may result. • Charge stored batteries before placing in use.

DISCARDING/RECYCLING BATTERIES Properly maintained FASTPAK batteries have a useful life of approximately two years. Properly maintained FASTPAK 2 batteries have a useful life up to five years. Properly maintained LIFEPAK SLA batteries have a useful life of up to three years. A FASTPAK, FASTPAK 2, or LIFEPAK SLA battery has reached the end of useful life if one or more of the following circumstances occur: • Battery fails conditioning or shelf life test. • There is physical damage to the battery case. • The battery is leaking. • The BSS 2 indicates DISCARD during any battery maintenance procedure. Note: The FASTPAK 2 and LIFEPAK SLA batteries have internal parameters that establish limits

for useful life. If these parameters are exceeded, the BSS 2 will indicate DISCARD when battery is inserted into the battery well.

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Battery Support System 2 Operating Instructions

Battery Maintenance

RBR

RC RB

C

To promote awareness of battery recycling, Physio-Control FASTPAK and LIFEPAK SLA batteries are marked with one of these symbols:

Ni-Cd

When a FASTPAK or LIFEPAK SLA battery reaches the end of its useful life, recycle the battery as follows:

Battery Recycling in the USA Recycle batteries by participating with Physio-Control Corporation in a national battery recycling program. Contact your local Physio-Control representative to obtain shipping instructions and shipping containers. Do not return your batteries to the Physio-Control Corporate Headquarters in Redmond, Washington, unless instructed to do so by your Physio-Control representative.

Battery Recycling Outside the USA Recycle batteries according to national and local regulations. Contact your local Physio-Control representative for assistance.

Battery Support System 2 Operating Instructions

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4

BSS 2 MAINTENANCE

This section describes the PHYSIO-CONTROL Battery Support System 2 maintenance. The BSS 2 Service Indicator Cleaning Fuse Replacement Troubleshooting Replacement Parts and Accessories Specifications Warranty Policy Product Recycling Information

Battery Support System 2 Operating Instructions

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