System 6 Aseptic Battery Kit Instructions for Use Rev AA Jan 2020

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6126-120-700 Rev-AA

Contents

Introduction

Introduction...2 Indications For Use...3 Contraindications...3 For Use With...3 User/Patient Safety...4 Definitions...4 Instructions...5 To Install Non-sterile Battery...5 Sterile Assistant Action...5 Circulating Assistant Action...6 Sterile Assistant Action...6 To Replace Battery...7 Care Instructions...7 Specifications...7

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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6126-120-700 Rev-AA

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Indications For Use

For Use With

The Stryker System 6 Aseptic Battery Kit provides a sterile enclosure for the Stryker Non-sterile Battery. After a Non-sterile Battery is charged, it is placed in a sterilized Aseptic Housing using a Transfer Shield. The housing containing the battery is then installed into a Stryker handpiece. See the For Use With section. Charge these battery packs on the System 6 Battery Charger (REF 6110-120-000) or the Universal Battery Charger (REF 7110-120-000). The charger must be configured with the System 6 Charger Module (REF 6110-625-000) only.

Stryker Aseptic Battery Kits are intended for use with the following Stryker handpieces: Aseptic Battery Kit*

Handpieces

REF 6126-000-000

System 6 Handpieces REF 620X-XXX-XXX series System 7 Handpieces REF 720X-XXX-XXX series Cordless Driver 3 REF 4300-000-000

*Includes Non-sterile Battery (REF 6126-110-000), Transfer Shield (REF 6126-130-000), and Aseptic Housing (REF 6126-120-000).

Contraindications None known.

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6126-120-700 Rev-AA

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 each component for damage. Damage may include, but is not limited to, bent contacts and cracks in the housing. DO NOT charge or use if damage is apparent. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen or nitrous oxide. • DO NOT modify any system component or accessory.

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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 Lock Unlock Refer to instruction manual/booklet General warning sign

DO NOT STERILIZE

Do not sterilize

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6126-120-700 Rev-AA

Instructions CAUTION: ALWAYS remove the non-sterile battery from the aseptic housing before charging the battery. Failure to comply may result in product damage. NOTES: • See the instructions supplied with the System 6 Non-sterile Battery and the battery charger used to recharge the batteries. Instructions contain important safety information and charging instructions. • Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only.

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Sterile Assistant Action 1. Open the lid.

2. With the aseptic housing chamber open, place the transfer shield onto the aseptic housing and over its chamber.

To Install Non-sterile Battery WARNING: DO NOT use the Aseptic Housing, Transfer Shield, or Non-sterile Battery unless they are dry. CAUTION: DO NOT allow the battery contact terminals to touch metal objects. Failure to comply may compromise battery performance and result in product damage. NOTE: Ensure more than one sterilized Aseptic Battery Kit is available in case a second battery installation is necessary.

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3. Present the chamber to the circulating assistant.

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6126-120-700 Rev-AA

Circulating Assistant Action WARNING: DO NOT contaminate the aseptic housing. The transfer shield guards the aseptic housing from contamination during battery installation. 4. Hold the non-sterile battery by the handle. 5. While aligning the battery’s housing profile with the transfer shield and chamber opening, place the non-sterile battery into the chamber.

6. Lay the battery handle flat against its housing. 7. Remove the contaminated transfer shield and set it aside.

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WARNING: Sterilize the contaminated transfer shield before using it again. See the care instructions manual supplied with the handpiece. Sterile Assistant Action 8. Close the aseptic housing lid and move the latch to the lock symbol. Ensure the dot on the latch aligns with the dot on the lock symbol.

WARNING: Ensure the dot on the latch aligns with the dot at the lock symbol. Failure to comply may allow the lid to open, exposing the non-sterile battery and result in patient injury. 9. Slide the aseptic housing containing the installed non-sterile battery firmly into the handpiece until it snaps into place.

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6126-120-700 Rev-AA

To Replace Battery WARNING: After installation, DO NOT remove a non-sterile battery from its sterile aseptic housing. If a new battery is required, use another sterile Aseptic Battery Kit and perform the installation procedure.

Care Instructions For processing instructions and disposal/recycle information, see the instructions for use supplied with the battery. To process the aseptic housing and transfer shield, see the care instructions manual supplied with the handpiece.

Specifications Model:

System 6 Non-sterile Battery (REF 6126-110-000)

Dimensions:

53 mm [2.1 inch] 53 mm [2.1 inch] 66 mm [2.6 inch]

Mass:

0.36 kg [0.79 lb]

Electrical:

2A charge (Direct Current) output 9.6 V

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Model:

System 6 Aseptic Housing (REF 6126-120-000)

Dimensions:

79 mm [3.1 inch] 74 mm [2.9 inch] 89 mm [3.5 inch]

Mass:

0.22 kg [0.49 lb]

Model:

System 6 Transfer Shield (REF 6126-130-000)

Dimensions:

48 mm [1.9 inch] 109 mm [4.3 inch] 196 mm [7.7 inch]

Mass:

0.09 kg [0.20 lb]

Mode of Operation:

See the recommended duty cycle information supplied with each handpiece.

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation: Humidity Limitation: Atmospheric Pressure Limitation: 7

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

6126-120-700 Rev-AA

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