SmartLife Aseptic Housings and Transfer Shields Instructions for Use Rev AC Jan 2021

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7126-120-700 Rev-AC

Contents

Introduction

Introduction...2 Indications For Use...3 Contraindications...3 User/Patient Safety...3 For Use With...4 Definitions...4 Features...5 Instructions...6 To Install Non-sterile Battery...6 Sterile Assistant Action...6 Circulating Assistant Action...7 Sterile Assistant Action...7 To Replace Battery...8 Care Instructions...8 Specifications...8

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, biomedical equipment technicians, and central supply/sterile processing 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. For additional information, especially safety information, or in-service training, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

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7126-120-700 Rev-AC

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.

Indications For Use The Stryker SmartLife Non-sterile Batteries are accessories to Stryker handpieces. These batteries are intended to supply energy to power Stryker handpieces which are for use in the cutting, drilling, decorticating, and smoothing of bone and other bonerelated tissue in a variety of surgical procedures. These batteries are only intended to be used with Stryker handpieces and are not intended to be autoclaved. The non-sterile battery is intended to be used with an appropriate Stryker aseptic housing and transfer shield. See the For Use With section. For additional information, see the instructions for use supplied with the handpiece. For charging instructions, see the instructions for use supplied with the charger.

Contraindications None known.

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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, operate the equipment and inspect each component for damage. Damage may include, but is not limited to, bent contacts and cracks in the housing. DO NOT use any equipment if damage is apparent. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen or nitrous oxide. NOTE: The product was designed and tested for 100 uses.

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7126-120-700 Rev-AC

For Use With Stryker SmartLife Aseptic Housings and Transfer Shields are intended for use with the following Stryker equipment: ASEPTIC HOUSING

TRANSFER SHIELD

NON-STERILE BATTERY

HANDPIECES

Large (REF 7126-120-000)

Large (REF 7126-130-000)

Large (REF 7126-110-000)

Small (REF 7222-120-000)

Small (REF 7222-130-000)

Small (REF 7222-110-000)

System 7 Handpieces (REF 720X-XXX-XXX series) Cordless Driver 4 (REF 4405-000-000) Sabo®2 (REF 4408-000-000)

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

SYMBOL

DEFINITION General warning sign

Unlock

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7126-120-700 Rev-AC

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Features

A

Non-sterile Battery – See the instructions for use supplied with the Stryker SmartLife Non-sterile Battery.

B

Transfer Shield – Guards the aseptic housing from contamination during battery installation.

C

Aseptic Housing – Encloses the battery and provides interface to the handpiece.

D

Battery Latch – Retains the aseptic housing in the handpiece.

E

Housing Contacts – Interlock with the handpiece to complete the electric circuit.

A

B

C

F

D G E

F

Lid

G

Housing Latch – Secures the lid.

H

Indicator Light Window – Allows the battery indicator light to be observed through the housing.

H

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7126-120-700 Rev-AC

Instructions CAUTION: ALWAYS remove the non-sterile battery from the aseptic housing before charging the battery. Failure to comply may result in product damage. NOTE: See the instructions for use supplied with the Stryker SmartLife Non-sterile Battery and the battery charger used to recharge the batteries. The instructions for use contain important safety information and charging instructions.

To Install Non-sterile Battery WARNING: DO NOT use the aseptic housing, transfer shield, or non-sterile battery unless they are dry.

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.

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 housing and transfer shield are available in case a second battery installation is necessary. 3. Present the chamber to the circulating assistant.

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7126-120-700 Rev-AC

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.

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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 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, which may result in patient injury. 7. Close the aseptic housing lid and move the latch toward the lock symbol. Ensure the dot on the latch aligns with the dot near the lock symbol.

6. Remove the contaminated transfer shield and set it aside.

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7126-120-700 Rev-AC

8. Slide the aseptic housing containing the nonsterile battery firmly into the handpiece until it snaps into place.

Model:

Stryker SmartLife Aseptic Housing, Small (REF 7222-120-000)

Dimensions:

9.50 cm [3.74 inch] length 7.44 cm [2.93 inch] width 8.51 cm [3.35 inch] height

Mass:

0.21 kg [0.47 lb]

Model:

Stryker SmartLife Transfer Shield, Large (REF 7126-130-000)

Dimensions:

18.97 cm [7.47 inch] length 12.42 cm [4.89 inch] width 3.91 cm [1.54 inch] height

Mass:

0.08 kg [0.18 lb]

Model:

Stryker SmartLife Transfer Shield, Small (REF 7222-130-000)

Dimensions:

15.32 cm [6.03 inch] length 12.42 cm [4.89 inch] width 3.91 cm [1.54 inch] height

Mass:

0.07 kg [0.15 lb]

Mode of Operation:

See the instructions for use supplied with the handpiece.

Environmental Conditions:

See the operation, storage, and transportation specifications in the instructions for use supplied with the handpiece.

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 housing and transfer shield and perform the installation procedure.

Care Instructions For processing instructions and disposal/recycle information, see the care instructions manual supplied with the handpiece.

Specifications

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Model:

Stryker SmartLife Aseptic Housing, Large (REF 7126-120-000)

Dimensions:

9.50 cm [3.74 inch] length 7.44 cm [2.93 inch] width 10.08 cm [3.97 inch] height

Mass:

0.24 kg [0.52 lb]

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Stryker Instruments 1941 Stryker Way Portage, Michigan (USA) 49002 1-269-323-7700 1-800-253-3210 2021-01

7126-120-700 Rev-AC

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