SmartLife Non-sterile Batteries Instructions for Use Rev AA Jan 2020

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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, 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.

7126-110-700 Rev-AA

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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7126-110-700 Rev-AA

For Use With

User/Patient Safety

The Stryker SmartLife Non-sterile Batteries are used to power Stryker System 7 (REF 720X-XXX-XXX series), Cordless Driver 4 (REF 4405-000-000), and Sabo®2 (REF 4408-000-000) handpieces. Charge these batteries 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). Stryker SmartLife Non-sterile Batteries are intended for use with the Stryker SmartLife Aseptic Housing and Transfer Shield: NON-STERILE BATTERY

ASEPTIC HOUSING

TRANSFER SHIELD

Large (REF 7126-110-000)

Large (REF 7126-120-000)

Large (REF 7126-130-000)

Small (REF 7222-110-000)

Small (REF 7222-120-000)

Small (REF 7222-130-000)

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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 battery 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. • DO NOT STERILIZE. • Risk of Fire, Burns and Explosion. Do not Short Circuit, Open, Crush, Incinerate, or Immerse. Consult instructions for use.

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7126-110-700 Rev-AA

Definitions

Features

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

A

B

DEFINITION General warning sign

DO NOT STERILIZE

C

Do not sterilize

+

Positive battery polarity terminal

–

Negative battery polarity terminal

A

Indicator Light – Provides status information for the battery: • The light will blink when the battery is near the end of its charge cycle. • The light will illuminate in a steady state for 10 seconds when the battery is expended.

B

Handle

C

Contacts – Interlock with the handpiece via the aseptic housing to complete the electric circuit.

Direct current

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7126-110-700 Rev-AA

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Instructions

• See the instructions for use supplied with the handpiece to properly install and remove the battery from the handpiece. • Typical battery run time is 20 minutes or longer, depending on surgical procedure or technique. • When the indicator light blinks, reducing the load on the handpiece may extend the usage time of the battery. • To install a non-sterile battery into an aseptic housing (REF 7126-120-000 or REF 7222-120000), see the instructions for use supplied with the housing.

CAUTION: ALWAYS remove the non-sterile battery from the aseptic housing before charging the battery. NOTES: • See the instructions for use supplied with the battery charger to properly charge the battery before each use. • A typical charging sequence will take between 5 and 30 minutes. Charging a fully expended large battery may take up to 75 minutes. • For maximum capacity, store the battery on the battery charger to maintain a full charge. DO NOT store the battery installed in a handpiece. Discharge will occur even though the handpiece is not operating. • Stryker recommends using batteries that have been charged within the last 10 days.

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7126-110-700 Rev-AA

Cleaning WARNING: Do not immerse or sterilize this battery. 1. Remove the non-sterile battery from the aseptic housing. 2. Inspect the battery housing 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.

Storage and Handling CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. See the Specifications section of the instructions for use supplied with the handpiece. To ensure the longevity, performance and safety of this equipment, use of the original packaging material is recommended for long-term storage or when transporting this equipment.

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Disposal/Recycle WARNINGS: • 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. • ALWAYS decontaminate a battery exposed to infectious material before sending it to a waste treatment facility. To comply with Batteries Directive 2006/66/EC, the battery has been designed to be recycled at the end-of-life by the end user as a complete unit. No disassembly is required.

Li-ION

Per Directive 2006/66/EC, collect and recycle batteries/battery packs according to EU Member State regulations. This rechargeable battery contains Lithium-Ion.

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7126-110-700 Rev-AA

Specifications Model:

Stryker SmartLife Non-sterile Battery, Large (REF 7126-110-000)

Stryker SmartLife Non-sterile Battery, Small (REF 7222-110-000)

Type:

Rechargeable, Lithium-Ion Battery

Rechargeable, Lithium-Ion Battery

Dimensions:

7.82 cm [3.08 inch] length 6.45 cm [2.54 inch] width 6.60 cm [2.6 inch] height

7.82 cm [3.08 inch] length 6.45 cm [2.54 inch] width 4.75 cm [1.87 inch] height 0.21 kg [0.46 lb]

Mass:

0.34 kg [0.76 lb]

Electrical Output:

Refer to battery housing for voltage rating.

Capacity:

Refer to battery housing for watt-hour rating.

Mode of Operation:

See the mode of operation in the instructions for use supplied with the handpiece.

Ingress Protection:

IPX0

Environmental Conditions:

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

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

7126-110-700 Rev-AA

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