System 6 Battery Packs Instructions for Use Rev AA Jan 2020

EN

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. Trademarks not the property of Stryker Corporation are the property of their respective owners.

Indications For Use Stryker System 6 Battery Packs are intended for use with Stryker handpieces only. 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.

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Contraindications None known.

For Use With Stryker System 6 Battery Packs are intended for use with the following Stryker handpieces: BATTERY PACK

HANDPIECES

System 6 Battery Pack, Small (REF 6212-000-000)

Cordless Driver 3 (REF 4300-000-000) Sabo® Sagittal Saw (REF 4300-034-000) System 6 Handpieces (REF 620X-XXX-XXX series)* System 7 Handpieces (REF 720X-XXX-XXX series)

System 6 Battery Pack, Large (REF 6215-000-000)

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

*Except the System 6 Sagittal Saw (REF 6208-000-000)

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6215-001-700 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 all components for damage. Damage may include 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. 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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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 General warning sign

Ni-Cd

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 NOTES: • Recharge battery packs before each surgery, even if they have not been used, to ensure the maximum running time. • The charge cycle takes approximately 5­­to 60 minutes. • The expected run time for each battery is 2.5 to 10 minutes depending on demand procedure utilization. • Only use battery packs that have been charged within the last 48 hours. • Store battery packs on the charger where they will be maintained fully charged until they are sterilized. DO NOT store battery packs in handpieces where they will discharge. Discharge will occur even though the handpiece is not running. • Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only.

Care Instructions

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

1. To properly install the battery pack into a handpiece, read and understand the appropriate Stryker handpiece instructions for use. 2. To properly charge the battery pack, read and understand the instructions for use provided with the Stryker System 6 Battery Charger (REF 6110-120-000).

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

System 6 Battery Pack, Large (REF 6215-000-000)

System 6 Battery Pack, Small (REF 6212-000-000)

Dimensions:

75.5 mm [2.98 inch] height 75.2 mm [2.96 inch] width 78.8 mm [3.11 inch] length

60.7 mm [2.39 inch] height 59.3 mm [2.34 inch] width 62.5 mm [2.46 inch] length

Mass:

0.54 kg [1.2 lb]

0.24 kg [0.52 lb]

Electrical:

Large Battery Pack

Small Battery Pack

2.0 A

1.0 A

Charge Output

9.6 V

(Direct Current)

9.6 V

(Direct Current)

Mode of Operation:

See the recommended duty cycle information supplied with each handpiece.

Ingress Protection:

IPX0 Ordinary Equipment

Environmental Conditions:

Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure Limitation:

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

6215-001-700 Rev-AA

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