System G Power Module -Battery Pack Instructions for Use Rev B June 2016

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7309-120-700 Rev-B

Contents

Introduction

Introduction . . . . . . . . . . . . . . . . . . 2

This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.

Audience . . . . . . . . . . . . . . . . 2 Conventions . . . . . . . . . . . . . . . 2 Contact Information . . . . . . . . . . . . 3 Indications For Use . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . 3 For Use With . . . . . . . . . . . . . . . . . 3 Safety Directives . . . . . . . . . . . . . . . . 4 Features . . . . . . . . . . . . . . . . . . . 5 Definitions . . . . . . . . . . . . . . . . . . . 5 Care Instructions... 6 Instructions . . . . . . . . . . . . . . . . . . 6

Audience This manual is intended for in-service trainers, physicians, nurses, and surgical technologists. Keep and consult this reference manual during the life of the product.

Conventions 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.

Storage and Handling . . . . . . . . . . . . . 7 Disposal/Recycle . . . . . . . . . . . . . . . 7 Specifications . . . . . . . . . . . . . . . . . 8 Product Safety Compliance . . . . . . . . . . . 9

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7309-120-700 Rev-B

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Contact Information

For Use With

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.

This section identifies components intended to be used with the equipment to obtain a safe combination. Description

REF

STRYKER SYSTEM G Rotary Drill

7305-001-000

Indications For Use

STRYKER SYSTEM G Reciprocating Saw

7306-001-000

The STRYKER SYSTEM G Power Module is intended to power the STRYKER SYSTEM G handpieces. The power module is a non-sterile, rechargeable unit, which is intended to be charged using the STRYKER SYSTEM G Charger.

STRYKER SYSTEM G Sagittal Saw

7308-001-000

STRYKER SYSTEM G Transfer Shield

7304-120-000

STRYKER SYSTEM G Charger, 2-Bay

7310-120-000

Contraindications None known.

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NOTE: For a complete list of components or ordering information, contact your Stryker sales representative or call Stryker customer service. See the Contact Information section. Outside the US, contact your nearest Stryker subsidiary.

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7309-120-700 Rev-B

Safety Directives

▪▪

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.

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DO NOT allow the battery contacts to touch metal objects.

WARNINGS: ▪▪

Before using this equipment, read and understand the instructions for use. Pay particular attention to safety information.

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Only trained and experienced healthcare professionals should use 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 does not recommend surgical procedure or technique.

▪▪

Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent. See the care instructions manual supplied with the handpiece for inspection criteria.

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7309-120-700 Rev-B

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Features

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.

A

Symbol

Definition General Warning Sign Caution

B DO NOT STERILIZE

Do not sterilize

A

Handle – Used to insert and remove the power module from the handpiece.

Consult instructions for use

B

Battery Contacts – Interlock with the battery charger to complete an electric circuit.

Universal Recycling Symbol

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7309-120-700 Rev-B

Symbol

Definition

1V

1 Volt

1A

1 Ampere

1 VA

1 Volt Ampere

1 Hz

1 Hertz

AC

Alternating Current

REF

Catalog Number

Care Instructions

Instructions WARNINGS: ▪▪

The power module is not supplied with a full charge. Always charge the power module before first use.

▪▪

ALWAYS use a STRYKER SYSTEM G Charger to charge power modules.

CAUTIONS: ▪▪

ALWAYS install the power module onto the charger to activate it before first use. A new power module will not function until it has been installed onto the charger.

▪▪

DO NOT store the power module installed in a handpiece. Discharge will occur even though the handpiece is not operating.

WARNINGS: ▪▪

Upon initial receipt and before each use, clean the equipment as indicated.

▪▪

DO NOT sterilize the power module.

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

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7309-120-700 Rev-B

Fully charge the power module before first and every use. NOTES: ▪▪

For charging instructions, see the instructions for use supplied with the battery charger.

▪▪

For maximum capacity, store the power module on the battery charger to maintain a full charge.

▪▪

Stryker recommends using power modules that have been charged within the last 5 days.

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To install and remove the power module from a handpiece, see the instructions for use supplied with the handpiece.

▪▪

Typical power module run time is 5 minutes or longer, depending on surgical procedure and technique.

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Storage and Handling CAUTION: ALWAYS transport and store the equipment within the specified environmental condition values: Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Disposal/Recycle WARNINGS: ▪▪

Power modules contain Lithium-ion material. Risk of fire, burns, and explosion. DO NOT short circuit, open, crush or incinerate. Consult instructions for use.

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▪▪

7309-120-700 Rev-B

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. To comply with European Community Batteries Directive 2006/66/EC, power modules have been designed to be recycled at the end-of-life by the end user as complete units. No disassembly is required. Power modules contain Lithium-ion material. Contains no hazardous substances, per China RoHS standard.

Specifications Model: Catalog Number:

STRYKER SYSTEM G Power Module 7309-120-000

Dimensions:

Length: 98 mm Width: 69 mm Height: 153 mm

Mass:

0.425 kg

Maximum Speed:

21000 revolutions per minute (nominal)

Electrical Input:

Internally Powered, 12.6 V (Direct current) maximum

Capacity:

21.6 Wh

Lithium-ion Code:

3INR 19/65

Ingress IPX0 Protection (IP): European Conformity: 8

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7309-120-700 Rev-B

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Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1J A1: R:2012 (3.1 Edition): Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2 (2007); Amendment 1 (2012) IEC 60601-1-6: 2013: USABILITY – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability – Edition 3.1 Consolidated Reprint. IEC 62366: 2014: USABILITY – Medical devices – Application of usability engineering to medical devices - Edition 1.1 Consolidated Reprint. IEC 60601-1-2: 2010: EMC (Version 3.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 3.0 IEC 62133: 2012/12/06 Edition: 2.0: Secondary Cells and Batteries Containing Alkaline or other NonAcid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications, Corrigendum 1:2013 European Committee for Electrotechnical Standardization (CENELEC) EN 60601-1:2006/A1:2013 (3.1 Edition): Medical electrical equipment Part 1: General requirements for basic safety and essential performance – Incorporates Amendment A12: 2014

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