SurePower Single Bay Charger Operators Guide Rev C Jan 2019

The issue date for the SurePower Single Bay Charger Operator’s Guide (REF 9650-000272-05 Rev. C) is January, 2019. SurePower and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners. Copyright © 2019 ZOLL Medical Corporation. All rights reserved. ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

Preface Using this Manual ...iv Organization ...iv Symbols Used on the Equipment ...v Conventions...vi Inspection and Service ... vii Contacting Technical Service ... vii Returning a Unit for Service... viii Safety...ix Warnings...ix Cautions...x Notes ...x FDA Tracking Requirements ...x Notification of Adverse Events...xi

Chapter 1

Product Overview

SurePower Single Bay Charger ... 1-1 Charger with SurePower... 1-2 Charger with SurePower II... 1-2 Battery Bay Panel ... 1-3 Charger and Battery Keys ... 1-4 Battery Charging Requirement ... 1-4 Charging Modes ... 1-5 QuickCharge... 1-5 ManualTest ... 1-5

Chapter 2

Set Up

Powering on the Charger ... 2-2 Self Test at Power On... 2-2

Chapter 3

Operation

Charging the SurePower and SurePower II Battery Packs ... 3-1 Troubleshooting Charging Faults... 3-5 Testing Batteries (Manual Procedure) ... 3-6 When Should You Test and Recalibrate a Battery? ... 3-6 Performing a Manual Battery Test ... 3-7 Testing the Battery Bay ... 3-8 Charger Operation -- General Information ... 3-9 Indicators When Powering On or Testing the Unit... 3-9 Indicators When Charging a Battery... 3-10 Indicators When Removing a Battery ... 3-11

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TABLE OF CONTENTS

Chapter 4

Maintenance and Troubleshooting

Inspection...4-1 Cleaning ...4-1 Troubleshooting ...4-2

Chapter 5

Using ZOLL Rechargeable Batteries Effectively

Getting the Most from Your SurePower Battery Pack and SurePower II Battery Pack ...5-1 Developing a Battery Management Program ...5-1

Chapter 6

Product Specifications - SurePower Single Bay Charger

Appendix A

Manufacturer’s Declaration - Electromagnetic Emissions and Immunity-Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

Electromagnetic Immunity Declaration (EID) ... A-2 EID for Non-Life-Support Functions ... A-3 Recommended Separation Distances from RF Equipment for Non-Life-Support Functions ... A-4

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Preface This manual describes how to set up, use, and maintain ZOLL Medical Corporation’s SurePower Single Bay Charger which you use to test, recalibrate, and charge ZOLL’s rechargeable lithium ion defibrillator batteries. It is important that you read and understand the information in this manual. The proper charging and maintenance of ZOLL’s rechargeable defibrillator batteries is critical to the reliable operation of your ZOLL defibrillator.

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Using this Manual This section describes the organization of the SurePower Single Bay Charger Operator’s Guide.

Organization We organize the manual as follows:

Preface Provides introductory information about this manual: the manual’s organization, the symbols and conventions that the manual uses, and important warnings and notices regarding the SurePower Single Bay Charger.

Chapter 1 Product Overview Provides a general overview of the SurePower Single Bay Charger.

Chapter 2 Set Up Describes how to set up the SurePower Single Bay Charger.

Chapter 3 Operation Describes how to use the SurePower Single Bay Charger to test, recalibrate, and charge ZOLL’s rechargeable defibrillator batteries.

Chapter 4 Maintenance and Troubleshooting Describes how to clean and maintain the SurePower Single Bay Charger and how to troubleshoot operating problems.

Chapter 5 Battery Management Provides general information how to run an effective battery management program. This chapter also provides general information on how to set up a battery management program.

Chapter 6 Product Specifications Provides a detailed list of product specifications for the SurePower Single Bay Charger.

Appendix A Manufacturer’s Declaration -- Electromagnetic Emissions Provides information on electromagnetic emissions in regard to the SurePower Single Bay Charger.

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Using this Manual

Symbols Used on the Equipment This manual, the SurePower Single Bay Charger, or the SurePower or SurePower II Battery Pack may display any or all of the following symbols:

Symbol

Description Attention! Refer to Operator’s Guide for important safety-related information, such as Warnings and Cautions that cannot be presented on the device.

DANGER high voltage present.

Protective (earth) ground terminal.

Alternating current.

Temperature Limitation.

Conformité Européenne Complies with medical device directive 93/42/EEC.

Contains lithium. Recycle or dispose of properly.

Keep away from open flame and high heat.

Do not discard in trash. Recycle or dispose of properly.

Nonionizing electromagnetic radiation.

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Symbol

Description Return to a collection site intended for waste electrical and electronic equipment (WEEE). Do not dispose of in unsorted trash.

With respect to electric shock, fire, mechanical, and other specified hazards only in accordance with IEC 60601-1 and CAN/CSA C22.2 No. 601.1, Medical Equipment Certified for USA and Canada 58NA.

IPX2

Equipment that is protected against harmful effects from water ingress of vertically falling water drip when enclosure is tilted up to 15°.

Manufacturer.

Authorized representative in the European Community.

Serial Number.

Catalogue number.

Consult the Operator’s Guide for information on the proper use of this device.

Conventions This manual uses the following convention:

Warning!

Warning statements describe conditions or actions that can result in personal injury or death.

Caution

Caution statements describe conditions or actions that result in damage to the SurePower Single Bay Charger. Note:

Notes contain additional information on using and maintaining the SurePower Single Bay Charger.

The manual displays button and LED labels in bold face type.

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Using this Manual

Inspection and Service When unpacking the SurePower Single Bay Charger, carefully inspect each container for damage. If the shipping container or cushion material is damaged, keep it until you have checked the contents for completeness and the unit has been checked for mechanical and electrical integrity. If the contents are incomplete, if there is physical damage, or if the unit does not pass its electrical self-test, North American customers should call ZOLL’s Technical Service Department. Customers outside the United States and Canada should contact their ZOLL authorized representative. If the shipping container is damaged, also notify the carrier.

Contacting Technical Service The SurePower Single Bay Charger does not require periodic recalibration or adjustment. You should, however, periodically perform the maintenance that this manual describes to verify proper operation of the unit If the SurePower Single Bay Charger requires service, North American customers should contact the ZOLL Technical Service Department: Telephone: 1-800-348-9011 1-978-421-9655 FAX:

1-978-421-0010

Customers outside the United States and Canada should contact their ZOLL authorized representative. When requesting service for the SurePower Single Bay Charger, please provide the following information to the Technical Service representative: • • • • •

Unit serial number Description of the problem Department using the equipment Purchase order to allow tracking of loan equipment Purchase order for a unit with an expired warranty

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Returning a unit for service If you need to send a SurePower Single Bay Charger to the ZOLL Technical Service Department for repair, obtain a service request (SR) number from the service representative. If you are returning a SurePower Single Bay Charger, remove all battery packs from the unit, and return the unit in the original containers or equivalent packaging, and be sure to include the service request number with the unit. For customers

Return the unit to ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105

In the U.S.A.

Attention: Technical Service Department (SR number) Telephone:1-800-348-9011 1-978-421-9655 Fax:1-978-421-0010 ZOLL Medical Canada, Inc. 1750 Sismet Rd., Unit#1

In Canada

Mississauga, ON L4W 1R6 Attention: Technical Service Department (SR number) Telephone: 1-866-442-1011 The nearest authorized ZOLL Medical Corporation representative To locate an authorized service center, contact the International Sales Department at

In other locations

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 Telephone: 1-978-421-9655

The ZOLL Serial Number Each ZOLL product displays a serial number that contains information about that product. From left to right, ZOLL serial numbers are structured as follows: • A two-character product code • A three-character date-of-manufacture code • A product serial number of six or more alphanumeric characters.

The product code for the SurePower Single Bay Charger is “AT” and one product code for the SurePower Battery Pack is “AG.” The first two characters of the date-of-manufacture code give the last two digits of the year (for example, “05” would appear for products manufactured in 2005). The last character of the dateof-manufacture code gives the month in which the product was manufactured. The month appears in the form of a single alphabetic character: “A” for January, “B” for February, “C” for March, and so on through “L” for December.

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Using this Manual The product serial number is a unique set of alphanumeric characters that ZOLL assigns to each individual unit.

Safety The following sections provide important warnings and notices regarding ZOLL’s SurePower Single Bay Charger.

Warnings • Always check that a battery pack’s Ready light is on before using the battery in a

defibrillator.

• Do not use the SurePower Single Bay Charger in a patient environment. • Charge only SurePower and SurePower II battery packs in the SurePower Single Bay

Charger. Charging other battery packs may cause overheating or damage.

• Accidental sliding or drop of the SurePower Single Bay Charger or battery may cause

•

•

• • •

• • • •

•

•

• •

physical injury. Operate the SurePower Single Bay Charger on a stable surface and be careful when carrying or moving the unit to avoid injury. Damaged batteries may expose users to a safety hazard. Should the SurePower Single Bay Charger or SurePower Battery Pack be dropped, inspect and test the unit prior to further use following the procedures described in this manual. Use caution when handling batteries with damaged case. Avoid prolonged exposure of the SurePower Single Bay Charger Operator’s Guide or SurePower Battery Pack to direct sunlight to minimize charger and battery heating and the damage that may occur from exposure to ultraviolet light. The SurePower Single Bay Charger and ZOLL rechargeable defibrillator batteries have been tested against interference from radio frequency emissions typical of two-way radios used in emergency service/public safety activities. Refer to Appendix A to determine recommended operating distances from RF transmission equipment. Use only the AC cord supplied with the device. Failure to use the proper line cord could result in excess leakage currents, EMC problems, and reduced safety. Do not disassemble the SurePower Single Bay Charger. A shock hazard exists. Refer all problems to qualified personnel. Do not place anything on top of or beneath the SurePower Single Bay Charger, such as blankets or cloths. Doing so may block the vents on the unit, preventing proper dissipation of heat during operation. Do not use the SurePower Single Bay Charger unit stacked with other equipment. Do not use a battery unless the charger’s Ready LED is lit and the Fault LED is off. Failure to do so may result in the use of a fully depleted battery. Use the SurePower Single Bay Charger only in a well-ventilated area. Should a battery become overheated, the battery can vent gas that is harmful and potentially explosive. An insulation or ground failure in the SurePower Single Bay Charger can result in dangerous leakage currents. To avoid this, perform periodic inspection following the procedures described in this manual. Do not operate the SurePower Single Bay Charger in the presence of flammable agents (such as gasoline), oxygen-rich atmospheres, or flammable anesthetics. Using the device in the presence of flammable agents can cause an explosion. Do not immerse or set the SurePower Single Bay Charger or SurePower Battery Pack in liquid. Using the device near or within puddles of water may present a shock hazard to the operator, patient, and nearby personnel. A pinch hazard exists when installing a battery into the charging bay. If the display indicators on a SurePower Battery Pack are not consistent with the indicators on the SurePower Single Bay Charger or ZOLL defibrillator, a charging fault condition is present. Remove the battery from service as soon as practical, and verify the correct operation of the charger, defibrillator, and battery.

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• Do not use the SurePower Single Bay Charger in environmental conditions that fall outside

• • • •

of those specified in Chapter 6, “Product Specifications-SurePower Single Bay Charger.” Using the SurePower Single Bay Charger in environmental conditions that fall outside those described in the product specifications can result in failure of the unit. Do not use the SurePower Single Bay Charger in the presence of Electrosurical Units (ESU). Do not short the power output pins (battery mating pins) of the charger. To avoid the risk of electric shock, the SurePower Single Bay Charger must only be connected to a supply mains with protective earth. Do not use the SurePower Single Bay Charger in the rain.

Cautions • Follow all recommended maintenance instructions. If a problem occurs, obtain service

immediately.

• Do not use ketones (MEK, acetone, etc.) to clean the SurePower Single Bay Charger. • Do not sterilize or autoclave the SurePower Single Bay Charger. • Do not touch the exposed pins in the charging bay -- if the pins are damaged, the charging

bay won’t be usable. These pins do not pose an electrical hazard.

• Do not install batteries into Monitor/Defibrillators or a SurePower Single Bay Charger that

is not plugged into live AC mains when storage may exceed 90 days. Battery damage may occur. • Do not connect any cables or devices to the covered connector port -- the connector port is only for ZOLL factory use. • Do not remove or discard the connector port cover.

Notes • If you are disposing of your SurePower Single Bay Charger, contact your local authorities

to determine the requirements for the recycling and disposal of electrical equipment and follow those requirements. • The end-of-life of the SurePower Single Bay Charger is determined by the availability of replacement parts and service for the unit. Contact ZOLL’s Technical Service Department for information on the availability of replacement parts and service for the SurePower Single Bay Charger.

FDA Tracking Requirements U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners of this device must notify ZOLL Medical Corporation if this product is • received • lost, stolen, or destroyed • donated, resold, or otherwise distributed to a different organization

If any such event occurs, contact ZOLL Medical Corporation in writing with the following information: 1. Originator’s organization- Company name, address, contact name, and contact phone number 2. Part number, model number, and serial number of the device

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Using this Manual 3. Disposition of the device (for example, received, lost, stolen, destroyed, distributed to

another organization), new location and/or organization (if known and different from originator’s organization) - company name, address, contact name, and contact phone number 4. Date when the change took effect Please address the information to: ZOLL Medical Corporation Attn: Tracking Coordinator 269 Mill Road Chelmsford, MA 01824-4105 Fax: (978)-421-0025 Tel: (978)-421-9655

Notification of Adverse Events As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA) for reporting the occurrence of certain events to ZOLL Medical Corporation and possibly, in the United States, to the Food and Drug Administration (FDA). These events, described 21 CFR Part 803, include device-related death and serious injury or illness. In any event, as part of our Quality Assurance Program, ZOLL Medical Corporation should be notified of any device failures or malfunctions. This information is required to ensure that ZOLL Medical Corporation provides only the highest quality products.

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Chapter 1 Product Overview - SurePower Single Bay Charger The ZOLL SurePower Single Bay Charger is a single-bay unit that can test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery.

Figure 1-1 SurePower Single-Bay Charger

The charging bay in the SurePower Single Bay Charger is designed to accommodate the following ZOLL rechargeable lithium ion batteries: • SurePower Battery Pack • SurePower II Battery Pack

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CHAPTER 1 PRODUCT OVERVIEW -SUREPOWER SINGLE BAY CHARGER

Charger with SurePower Battery Pack The following illustration is of a SurePower Single Bay Charger with a SurePower Battery Pack installed in it.

?

Charger with SurePower II Battery Pack The following illustration is of a SurePower Single Bay Charger with a SurePower II Battery Pack installed in it.

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Battery Panel At the front of the bay is an information and control panel:

Figure 1-2 Charger Control Panel

The panel has five LEDs with identifying icons and a Test button: Charging. The LED lights next to this icon to indicate that the battery is charging.

Ready. The LED lights next to this icon to indicate that the battery is fully charged and ready to use.

Test button. Pressing this button initiates a manual test of the battery.

Test. The LED light next to this icon to indicate that the charger is testing the battery.

Fault. The charger has determined that there is a charging fault. If there is no battery in the charging bay, the charger has determined that there is a an internal fault with charger.

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CHAPTER 1 PRODUCT OVERVIEW -SUREPOWER SINGLE BAY CHARGER Power. The LED light next to this icon indicates that the charger is connected to the AC mains.

Charger and Battery Keys ZOLL’s defibrillator batteries and the bay in the SurePower Single Bay Charger are keyed to prevent incompatible batteries from seating in the charging bay and damaging the SurePower Single Bay Charger. The following illustration shows the key on the SurePower Single Bay Charger.

Figure 1-3 Battery Key

Batteries that do not have the correct keys will not seat in the charging bay and cannot be charged and tested by the SurePower Single Bay Charger. Caution

Do not use the SurePower Single Bay Charger to charge any battery packs which are not designed for use with SurePower Single Bay Chargers.

Battery Charging Requirement Each battery type has its own charging requirements. When you place a battery pack into the bay of a SurePower Single Bay Charger, the charger identifies the battery type and the battery communicates its charging requirements to the charger.

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Charging Modes

Charging Modes The SurePower Single Bay Charger supports two charging modes: QuickCharge and ManualTest. These charging modes control how quickly the charger brings the battery to full charge and whether or not the battery’s runtime indicator is recalibrated.

QuickCharge The QuickCharge charging mode immediately charges the depleted battery. The QuickCharge charging mode is the default charging method for ZOLL’s lithium ion batteries, such as the SurePower Battery Pack. The QuickCharge mode is the quickest way to charge lithium ion batteries, which do not require frequent testing to maintain their usable life.

ManualTest The ManualTest charging mode tests and recalibrates ZOLL batteries. The SurePower and SurePower II Battery Packs automatically recalibrate themselves. We describe how to perform a ManualTest in Chapter 3. In summary, the SurePower Single Bay Charger can ensure the availability of fully-charged defibrillator batteries in an emergency situation. SurePower and SurePower II Battery Packs can be recharged, recalibrated, and tested by this device.

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