Hall Large Lithium Battery Instructions for Use Rev AG

ENGLISH/ INSTRUCTIONS FOR USE

Hall® Large Lithium Battery Catalog #

Description

L3000LG

Hall® Large Lithium Battery

DESCRIPTION The rechargeable Hall® Large Lithium Battery (L3000LG) is used to power all approved Hall battery handpieces except PowerPro. This battery is charged using the Hall Lithium Battery Charger (L3000). For more detailed information about the Battery Charger, reference the Hall Lithium Battery Charger (L3000) manual. Battery packs are shipped non-sterile and not fully charged. Always clean, charge and sterilize battery packs before use.

INTENDED USE The rechargeable Hall Large Lithium Battery (L3000LG) is intended to power all approved Hall battery handpieces except PowerPro.

WARNINGS 1. T  his equipment is designed for use by medical professionals familiar with the instructions for use. Prior to use, read and follow all warnings, precautions and instructions marked on the product and included in this manual. 2. Do not short circuit battery terminals or allow them to come into contact with metal objects. This could cause a shock or burn injury and also damage the battery pack. 3. Inspect battery pack for damage (e.g., cracks in battery case, corrosion on contacts, etc) prior to use. Do not use damaged battery packs. If battery pack is damaged and leakage or residue is noticed, do not allow it to come in contact with skin, eyes or clothing. Burns may result. If contact occurs, flush area with copious amounts of water and seek medical attention immediately. Dispose of or recycle in accordance with your local, state and government regulations. 4. The battery pack used in this device may present a risk of fire or chemical burn if mistreated. Do not disassemble, heat above 278°F (137°C), or incinerate. Replace battery with approved Hall Lithium Batteries only. Use of another battery may present a risk of fire or explosion.

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PRECAUTIONS 1. C  harge this battery using the Hall Lithium Battery Charger (L3000) only. Use of any non-approved charger may cause injury or damage to the battery. 2. Dispose of used battery promptly. Keep away from children. Do not disassemble and do not dispose of in fire. These battery packs contain lithium iron phosphate which must be recycled or disposed of properly. The disposal of lithium iron phospate batteries as municipal waste is prohibited. Dispose of or recycle in accordance with your local, state and government regulations. In the U.S., call 1-866-426-6633 for additional information on battery pack disposal or recycling. Outside the U.S. contact your local CONMED representative. 3. Depletion of the battery charge results if the battery pack is attached to a handpiece while the handpiece is not used or is stored. 4. Do not drop, as this could damage the battery potentially creating an unsafe condition. 5. Do not immerse battery pack in any liquid or solution. Contact corrosion may occur resulting in decreased battery and/or handpiece performance. 6. Do not clean battery pack with bleach, chlorine-based detergent, or caustic solutions that contain phenol. Contact corrosion may occur resulting in decreased battery and/or handpiece performance. 7. Do not expose battery pack to fire or incineration; this may cause the battery to rupture, potentially creating an unsafe condition. 8. Battery pack should be completely discharged if returned to manufacturer. 9. Lithium iron phosphate batteries lose approximately 3% of charge per month during storage at nominal room temperature. It is recommended that the batteries be stored on the charger while not in use to assure full charge.

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INSTRUCTIONS FOR USE 1. A  lways clean battery packs prior to charging. See “Cleaning” information in the “CLEANING and STERILIZATION GUIDELINES” section.

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2. Slide a clean, dry battery pack onto a battery charger station until it locks into place. Charging begins automatically. 3. A battery charge icon displays during the charge cycle. Note: For examples of icon symbols refer to the Hall Lithium Battery Charger (L3000) manual. 4. A charge complete icon displays when a battery pack completes a charge cycle. A complete charge is obtained in approximately 30 minutes. 5. When the faulty battery icon displays, replace the battery. 6. After charging, sterilize battery packs. See “Sterilization” information in the “CLEANING and STERILIZATION GUIDELINES” section.

CLEANING and STERILIZATION GUIDELINES 1. S  trict adherence to recommended sterilization procedure is necessary to prevent a possible delay in surgery. Heat exposure and age have the greatest impact on battery life, leading to failure. Ensure the following: a. Do not leave battery pack in the autoclave longer than the recommended sterilization cycle. b. Remove the battery pack from the autoclave chamber immediately following the recommended sterilization cycle. 2. Follow universal precautions for protective apparel when handling and cleaning contaminated batteries. 3. Always remove battery pack from handpiece prior to cleaning and sterilization. 4. Always clean battery pack prior to charging and sterilizing. 5. Do not sterilize battery pack while connected to handpiece. 6. Do not use battery pack while warm. Allow adequate time for cooling prior to use. Do not immerse in liquid or cover with a damp cloth to cool. Cool by exposure to room temperature. Operation of a battery pack that is not completely cool and dry may decrease performance and/or reliability. 7. See handpiece instruction manual for additional warnings and precautions. Manual Cleaning PRECAUTION: Cleaners, presoak sprays or similar products available on the market that are designed to remove organic soils are known to react negatively with plastic and/or metal. Therefore it is recommended that if any of these items are used in the processing of the Hall Large Lithium Battery, the battery must be thoroughly rinsed under running water for a minimum of 10 seconds to remove all residue before sterilization. Failure to do so may result in degradation of the plastic and/or metal of the battery causing premature cracking or breaking. 1. Clean the battery pack after each use with a lint-free cloth dampened with a pH-balanced detergent of your choosing. Follow the manufacturer’s instructions for preparation of the cleaning product selected and ensure that it is approved for use on plastics. Failure to follow these guidelines may cause damage to the battery pack. Remove all traces of blood and coagulated material, etc. Repeat as necessary until clean. 2. After cleaning the battery pack, rinse the battery pack under running water (minimum temperature 25°C/77°F) for a minimum of 10 seconds using a minimum of 500 milliliters of rinse water. Ensure battery is visibly free of detergent or cleaning residues. Thoroughly wipe the battery pack with a lint-free cloth moistened with deionized water. Note: Tap water can cause mineral deposits to collect on the contacts which may affect operation of the handpiece. 3. Dry with a clean, lint-free cloth. 4. At least once a week, thoroughly clean the metal contact points on the battery pack. Use a cotton swab and a non-abrasive cleaning product approved for use with metal. Repeat cleaning as necessary. Automated Cleaning 1. Under running water or using a dampened lint-free cloth, remove all traces of blood and debris. 2. Load battery in washer/sanitizer, ensuring proper battery orientation as displayed in the image below.

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3. Run washer/sanitizer according to the manufacturer’s specifications. A dry cycle is recommended but not required.

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Sterilization 1. Sterilization of battery packs can be done using steam or STERRAD®1. WARNING: The use of disinfecting solutions for an exterior battery wipe will not sterilize the equipment and is not recommended. Individually double wrap batteries. In the United States, use FDA cleared sterilization wrap.

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Table 1: Sterilization Parameters for Hall Lithium Battery without a System Sterilization Tray in the United States Steam Sterilization for Batteries Intended to be Stored for Later Use Method

Cycle

Temperature

Exposure

Dry Time

Steam (Wrapped)

Pre-Vacuum

270°F (132°C)

3 minutes

20 minutes

Steam Sterilization for Batteries Intended for Immediate Use Method

Cycle

Temperature

Exposure

Dry Time

Steam (Wrapped)

Pre-Vacuum

270°F (132°C)

3 minutes

No Dry Time

Table 2: Sterilization Parameters for Hall Lithium Battery Outside the United States Steam Sterilization for Batteries Intended to be Stored for Later Use Method

Cycle

Steam (Wrapped)

Min Temperature

Max Temperature

Min Exposure Max Exposure

Dry Time

Pre-Vacuum 273°F (134°C)

278°F (137°C)

3 minutes

4 minutes

20 minutes

Steam Pre-Vacuum 273°F (134°C) (In Aluminum Tray)

278°F (137°C)

4 minutes

18 minutes

45 minutes*

Steam Sterilization for Batteries Intended for Immediate Use Method

Cycle

Min Temperature

Steam (Wrapped)

Pre-Vacuum 273°F (134°C)

Max Temperature

Min Exposure Max Exposure

Dry Time

278°F (137°C)

3 minutes

No Dry Time

4 minutes

*Refer to Hall Sterilization Tray IFUs for tray specific sterilization parameters. WARNING: Wet batteries should not be stored for use at a later time. Failure to use immediately could compromise sterility of the battery. PRECAUTION: Batteries should not be subjected to consecutive “Immediate Use” cycles. Ensure a dry cycle is performed in between “Immediate Use” cycles. Failure to dry battery could lead to degradation of performance. Note: Batteries have been tested for survivability up to 278°F (137°C) with an 18 minute exposure time and a 45 minute dry time within approved aluminum tray. The battery described in this manual has been approved for sterilization in the STERRAD® 100S, 200, 50, NX®, 100NX® Systems.

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STERRAD® System STERRAD® 100S and STERRAD® 200 STERRAD 50 ®

STERRAD® NX® STERRAD 100NX®

Cycle

Comments

SHORT

Only Cycle available in the US

LONG

Only Cycle available outside the US

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-

STANDARD

-

ADVANCED

-

EXPRESS

-

STANDARD

-

Testing was performed in accordance with AAMI TIR No. 12-2010 guidelines, “Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Heath Care Facilities: A Guide for Device Manufacturers.” Please refer to the STERRAD System User’s Guides for general reprocessing instructions, including proper cleaning, and drying, and packaging information prior to reprocessing any medical device in a STERRAD System.

1. STERRAD®, STERRAD® 100S, STERRAD® 200, STERRAD® 50, STERRAD® NX®, and STERRAD 100NX® are registered trademarks of Advanced Sterilization Products (ASP) Division of Ethicon, Inc. a Johnson & Johnson company.

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SPECIFICATIONS L3000LG Weight:

18.7 oz. (530 g)

Type:

Lithium Iron Phosphate (4 cells)

Capacity:

2.5 A-h (amp. hr.)/33 W-h

Voltage:

13.2 VDC

Color:

Black

Environmental Conditions

Operating

Temperature:

Storage and Transport 70° C 158° F

25° C 77° F 10° C 50° F

-20° C -4° F

Relative Humidity:

75%

30%

Non-Condensing 1060 hPa

Atmospheric Pressure: 700 hPa

93%

10%

Non-Condensing 1060 hPa

500 hPa

See Hall Lithium Battery Charger (L3000) manual for Electromagnetic Emissions/ Immunity Considerations.

PACKAGING AND LABELING Upon initial receipt of the product, this device should only be used if the original packaging and labeling are intact. If packaging has been opened or altered, contact your local CONMED representative, or in the U.S. contact the Customer Service Department (1-866-426-6633).

CONTACT INFORMATION For more information or a product demonstration, contact your regional sales representative, or call 1-866-426-6633 in the U.S.

RETURNING BATTERIES Due to International Air Transport Association (IATA) regulations, this device cannot be returned by AIR transport. This battery must be return shipped by GROUND. For questions, please contact your regional sales representative, or call 1-866-426-6633 in the U.S.

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MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

525 French Road Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com All rights reserved.

W55-000-771

Rev AG

UKRP CONMED UK Ltd 73/74 Shrivenham Hundred Business Park Swindon SN6 8TY United Kingdom

SPC1592400 Rev A SPC1592399 Rev B

05/2022