System 8 Battery Packs Instructions for Use Oct 2016

System 8 Battery Packs 8212-000-000 8215-000-000 Instructions For Use

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Print Date: Dec 02, 2016 08:32:12 AM 0000226015, Rev. - Effective Date: Dec 2, 2016 8:29:56 AM

www.stryker.com

EN

8215-001-700 Rev-

Introduction

Indications For Use

This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product. This manual is intended for in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product.

See the instructions for use supplied with the handpiece.

Contraindications See the instructions for use supplied with the handpiece.

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, including safety information, in-service training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-269-323-7700 or 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.

For Use With The battery pack is only intended for use with the following Stryker handpieces: DESCRIPTION

REF

System 8 Handpieces

820X-XXX-XXX series

System 7 Handpieces

720X-XXX-XXX series

System 8 Cordless Driver

4505-000-000

Cordless Driver 4

4405-000-000

System 8 Sabo® Sagittal Saw

4508-000-000

Sabo2 Sagittal Saw

4408-000-000

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8215-001-700 Rev-

EN

Charge the battery pack with one of the following Stryker battery chargers configured with a Stryker System 6 Charger Module (REF 6110-625-000): DESCRIPTION

REF

Universal Battery Charger

7110-120-000

System 6 Battery Charger

6110-120-000

Safety Directives WARNINGS: • Before using this equipment, or any component compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. • Only healthcare professionals trained and experienced in the use of this medical device should operate this equipment.

• The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. • Upon initial receipt and before each use, inspect the equipment for damage. DO NOT use any equipment if damage is apparent. • Before use, ALWAYS allow the equipment to reach the operation temperature range specified in the instructions for use supplied with the handpiece. • To prevent the equipment from overheating, ALWAYS follow the recommended duty cycle specified in the instructions for use supplied with the handpiece. • DO NOT allow the battery contacts to touch metal objects.

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Print Date: Dec 02, 2016 08:32:12 AM 0000226015, Rev. - Effective Date: Dec 2, 2016 8:29:56 AM

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Features

Definitions C B

A

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 General warning sign Battery pack status (indicator light)

A

Indicator Light – Provides status information for the battery pack. The light will illuminate in a steady state for 10 seconds when the battery pack is expended.

B

Battery Latch – Retains the battery pack in the handpiece.

C

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

WARNING ADVERTISSEMENT

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Print Date: Dec 02, 2016 08:32:12 AM 0000226015, Rev. - Effective Date: Dec 2, 2016 8:29:56 AM

WARNING: Battery contains Lithium-ion material. Risk of fire, burns, and explosion. DO NOT short circuit, open, crush or incinerate. Sterilize only per instructions. Consult instructions for use.

www.stryker.com

8215-001-700 Rev-

EN

Instructions

Care Instructions

NOTES:

For processing instructions, see the care instructions manual supplied with the handpiece.

• See the instructions for use supplied with the battery charger to properly charge the battery pack before each use.

Disposal/Recycle

• For maximum capacity, charge the battery pack before sterilization, even if the battery pack has not been used. • A typical charging sequence will take between 5 and 30 minutes. Charging a fully expended large battery pack may take up to 90 minutes. • For maximum capacity, store the battery pack on the battery charger to maintain a full charge. DO NOT store the battery pack installed in a handpiece. Discharge will occur even though the handpiece is not operating. • Stryker recommends using battery packs that have been charged within the last 30 days. • See the instructions for use supplied with the handpiece to properly install and remove the battery pack from the handpiece.

This rechargeable battery pack contains Lithium-Ion.

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.

• When the indicator light blinks, reducing the load on the handpiece may extend the usage time of the battery pack. www.stryker.com

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Specifications CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. Model:

System 8 Battery Pack, Small (REF 8212-000-000)

Type:

Rechargeable, Lithium-Ion Battery Pack

Dimensions:

58 mm [2.3 inch] height 71 mm [2.8 inch] width 84 mm [3.3 inch] length

Mass:

0.27 kg [0.60 lb]

Voltage:

9.9 V

Energy:

13.4 Wh

26.7 Wh

Current:

30 A (Limited)

60 A (Limited)

Capacity:

1350 mAh

2700 mAh

Mode of Operation:

See the instructions for use supplied with the handpiece.

Ingress Protection:

IPX0

Environmental Conditions:

See the instructions for use supplied with the handpiece.

(Direct current)

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System 8 Battery Pack, Large (REF 8215-000-000) 76 mm [3.0 inch] height 71 mm [2.8 inch] width 84 mm [3.3 inch] length 0.42 kg [0.93 lb] 9.9 V

www.stryker.com

Print Date: Dec 02, 2016 08:32:12 AM 0000226015, Rev. - Effective Date: Dec 2, 2016 8:29:56 AM

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 2016-10

8215-001-700 Rev-

Print Date: Dec 02, 2016 08:32:12 AM 0000226015, Rev. - Effective Date: Dec 2, 2016 8:29:56 AM

www.stryker.com

Signature History Report Version

Signature

Role

Event Date

Vote

-

Volstromer, Craig

CA_Owner

2016-10-19 06:49:51 EDT

Continue

-

Sidow, Brian

CA_Clinical Sciences 2016-10-19 07:59:21 EDT

Approve

-

Modi Karankumar

CA_Regulatory Affairs

2016-10-23 15:23:20 EDT

Approve

-

Mouatt, Gerard

CA_Product Design Engineer

2016-10-24 13:35:28 EDT

Approve

-

Eggleston Ryan

CA_Quality Engineer

2016-10-24 15:49:19 EDT

Approve

-

Burke Adam

CA_Marketing Manager

2016-10-27 11:14:08 EDT

Approve

-

Morgan, Carianne

CA_Product Safety

2016-10-27 21:25:42 EDT

Approve

-

Schrauben Haley

Editor

2016-12-01 15:19:54 EST

Continue

NOTE: IF THIS REPORT IS BLANK, PLEASE SEE WINDCHILL ECN FOR SIGNATURES.

Related Information CR Number

CR0296241

CR Class

DMR-All Pre-Commercial Release

Originating Entity

INST: Kalamazoo

Origin

New Product Development

Initial CR Approval Date

05/04/2016 07:24:20

CN Number

CN155348

CA Number

CA184803

NPD Disposition Plan

none

Print Date: Dec 02, 2016 08:32:12 AM 0000226015, Rev. - Effective Date: Dec 2, 2016 8:29:56 AM