T4 Power Pack Instruction for Use Rev H May 2013

0400-650-704 Rev-H

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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, 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, including safety 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.

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0400-650-704 Rev-H

Indications For Use See the instructions for use supplied with the Stryker T4/T5 Helmets.

Contraindications See the instructions for use supplied with the Stryker T4/T5 Helmets.

Intended Use The Stryker T4 Power Pack provides electrical power to the T3 Helmets, T4 Helmets, and T5 Helmets REF 0400-610-000, 0400-635-000, 0400-645-000, and 0400-675-000.

For Use With The T4 Power Pack is charged in the following Stryker battery chargers:

4

DESCRIPTION

REF

T4 Battery Charger (USA)

0400-655-000

T4 Battery Charger (EUROPE)

0400-655-001

T4 Battery Charger (JAPAN)

0400-655-002

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0400-650-704 Rev-H

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User/Patient Safety WARNINGS: • Before using any component, or any component compatible with this equipment, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the components prior to use. • Only trained and experienced healthcare professionals should use this equipment. • Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent. • ALWAYS clean the power pack before first and every use. • DO NOT use a power pack that gives off an odor, generates heat, becomes discolored, or leaks. • DO NOT short circuit, crush, incinerate or disassemble. Damage increases the risk of chemical burns from electrolyte leakage, fire or explosion. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen or nitrous oxide. CAUTION: DO NOT sterilize or immerse.

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Accessories WARNINGS: • Use only Stryker-approved components and accessories, unless otherwise specified. Failure to comply may result in fire, electric shock, or injury. • Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. • DO NOT modify any component or accessory, unless otherwise specified. NOTE: For more information or a complete list of accessory information, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

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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 Caution Refer to Instruction Manual/Booklet

Consult Instructions for Use

Direct Current (DC)

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0400-650-704 Rev-H

Instructions To clean, inspect and test, or charge a power pack, see the instructions for use supplied with the Stryker T4 Charger. To use a power pack, see the instructions for use supplied with the T3, T4, or T5 Helmet.

Cleaning See the instructions for use supplied with the charger.

Inspection and Testing See the instructions for use supplied with the charger.

Troubleshooting WARNING: DO NOT disassemble or service this equipment, unless otherwise specified. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. See the instructions for use supplied with the charger.

Storage and Handling See the instructions for use supplied with the charger.

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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 equipment exposed to infectious material before sending it to a waste treatment facility. Per Directive 2006/66/EC, collect and recycle batteries/battery packs according to EU Member State regulations. The rechargeable power pack contains Nickel Metal Hydride material.

50

Years of environmentally-friendly use, per China RoHS standard.

To comply with Batteries Directive 2006/66/EC, the power pack has been designed to be recycled at the end-of-life by the end user as a complete unit. No disassembly is required.

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Specifications Model:

T4 Power Pack REF 0400-655-003

Electrical Output:

6.0 V

Duration:

4 to 5 hours at highest fan speed setting

Mode of Operation:

See the instructions for use supplied with the helmet.

Ingress Protection (IP):

IPX0

Environmental Conditions:

Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure Limitation:

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

Stryker France ZAC Satolas Green Pusignan Av. de Satolas Green 69881 MEYZIEU Cedex France 2013-05

0400-650-704 Rev-H

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