Non-sterile Batteries Instructions for Use Rev AA Jan 2020

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4126-110-700 Rev-AA

Introduction This Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. If additional information or in-service training is required, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

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4126-110-700 Rev-AA

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Indications For Use Non-sterile Batteries REF 4126-110-000 and 4222-110-000 are used to power certain Stryker handpieces. See the For Use With section.

Contraindications None known.

For Use With Stryker Non-sterile Batteries are intended for use with the following Stryker Battery Protector Kits: Non-sterile Battery

Battery Protector Kit*

REF 4126-110-000

REF 4126-000-000 REF 4226-000-000

REF 4222-110-000

REF 4222-000-000 REF 6127-000-000

*Includes Non-sterile Battery, Transfer Shield, and Aseptic Housing.

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4126-110-700 Rev-AA

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User/Patient Safety WARNINGS:

• Only trained and experienced healthcare professionals should use this equipment. Before using any system component or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • Upon initial receipt and before each use, inspect Non-sterile Batteries for damage. DO NOT charge or use if there is evidence of damage. Electrolytes may leak from damaged batteries and cause serious chemical burns to the surgical site, skin and/or eyes. • DO NOT modify any system component or accessory. • DO NOT sterilize these batteries. After charging, a Non-sterile Battery is placed in a sterilized Aseptic Housing, then loaded into a handpiece. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen or nitrous oxide. CAUTIONS:

• Before placement in the charger, Non-sterile Batteries must be thoroughly dry or batteries and charger may become damaged. • At the first indication that a Non-sterile Battery is low on energy, replace it with a fully charged Non-sterile Battery.

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4126-110-700 Rev-AA

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NOTES:

• Before each surgery, recharge Non-sterile Batteries even if they have not been used. This ensures the maximum charge is available. • Expected Non-sterile Battery run time is 2.5 to 10 minutes depending on procedure utilization. • Use Non-sterile Batteries that have been charged within the last 48 hours. • Never store a Non-sterile Battery in the handpiece. It will discharge energy even though the handpiece is not running. • Store Non-sterile Batteries in the charger until they are needed for surgery. This is the best method of storage for extended periods. • Have several charged Non-sterile Batteries available for the procedure.

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Definitions The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL

DEFINITION Refer to instruction manual/booklet

General warning sign

Ni-Cd

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To comply with European Community Batteries Directive 2006/66/EC, this device has been designed for safe removal of the batteries at the end-of-life by a waste treatment facility. Infected units should be decontaminated before they are sent for recycling. If it is not possible to decontaminate the unit for recycling, the hospital should not attempt to remove the batteries from waste equipment. Continued disposal of small amounts of portable batteries to landfill and incineration is allowed under Directive 2006/66/EC and Member State regulations.

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Instructions Charging the Battery Charge the Non-sterile Batteries in a Stryker System 4 or 5 Charger configured with Charger Module REF 4110-426-000, or charge the Non-sterile Batteries in a Stryker System 6 Charger configured with Charger Module REF 6110-426-000. • See instructions supplied with charger for details. • Charge Non-sterile Batteries at normal room temperature, approximately 64-75 °F [18-24 °C]. Charge time: approximately 5 to 45 minutes.

Periodic Maintenance NOTE: Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only.

Storage and Handling CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. See the Specifications section. To ensure the longevity, performance and safety of this equipment, use of the original packaging material is recommended when storing or transporting this equipment. www.stryker.com

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4126-110-700 Rev-AA

Recycle/Disposal WARNING: ALWAYS Follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life.

Cleaning WARNING: DO NOT immerse or sterilize this battery.

1. Remove the Non-sterile Battery from the Battery Protector Kit. 2. Inspect the Non-sterile Battery for cracks or damage. DO NOT use the battery if damage is apparent. CAUTION: Do not rinse, spray, or wipe the battery with a saturated cloth.

3. Wipe the Non-sterile Battery with a clean dry cloth.

Limited Warranty For selected products. Batteries are warranted for a period of 90 days from the date of invoice.

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Specifications NOTE: Specifications are approximate and may vary between devices. Model:

Non-sterile Large Battery (REF 4126-110-000)

Non-sterile Small Battery (REF 4222-110-000)

Dimensions:

47 mm [1.9 inch] height 73 mm [2.9 inch] width 91 mm [3.6 inch] length

40 mm [1.6 inch] height 57 mm [2.2 inch] width 71 mm [2.8 inch] length

Mass:

0.36 kg [0.79 lb]

0.16 kg [0.35 lb]

Electrical:

1.75 A Charge (Direct Current) 9.6 V Output

1.0 A Charge 9.6 V (Direct Current) Output

Environmental Conditions:

Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure Limitation: Not user serviceable.

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JA/ZH/KO

4126-110-720

Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2020-01

4126-110-700 Rev-AA

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