System G Power Module Instructions for Use Rev AB

EN

7309-120-700 Rev-AB

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 . . . . . . . . . . . . . . . 8 Product Safety Compliance . . . . . . . . . . 10 Specifications . . . . . . . . . . . . . . . . 11

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7309-120-700 Rev-AB

EN

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-AB

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.

▪

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.

▪

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-AB

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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-AB

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-AB

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.

▪

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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EN

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

Humidity Limitation

Atmospheric Pressure Limitation

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7309-120-700 Rev-AB

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.

▪

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. In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended, product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling.

NOTE: Contact Stryker for the recycling passport for this product. The Batteries Directive 2006/66/EC introduces new requirements from September 2008 on removability of batteries from waste equipment in EU Member States. To comply with this Directive, this device has been designed for safe removal of the batteries at end-of-life by a waste treatment facility. Infected units should be decontaminated before they are sent for recycling. In the case that 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 the Batteries Directive 2006/66/EC and Member State regulations. Power modules contain Lithium-ion material.

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7309-120-700 Rev-AB

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China RoHS Standard SJ/T 11364 To comply with China RoHS Standard SJ/T 11364, this device has been marked with the environmentallyfriendly use period (EFUP) number, measured in years. The device contains at least one of the listed hazardous substances above threshold.

China RoHS Disclosure Report REF 7309-120-000 Hazardous Substances Part Name

Electronic Circuit Boards

Lead (Pb)

Mercury (Hg)

Cadmium (Cd)

Hexavalent Chromium (Cr [VI])

Polybrominated biphenyls (PBB)

Polybrominated diphenyl ethers (PBDE)

X

O

O

O

O

O

This table is prepared in accordance with the provisions of SJ/T11364. O: Indicates that said hazardous substance contained in all of the homogenous materials for this part is below the limit requirement of GB/T26572. X: Indicates that said hazardous substance contained in at least one of the homogenous materials used for this part is above the limit requirement of GB/T26572.

Material: In accordance with the European REACH regulation and other environmental regulatory requirements, components within the power module contain Lead Cas. No. 7439-92-1. This declaration is made in good faith and is either based on a technical evaluation, supplier data and/or laboratory testing. www.stryker.com

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7309-120-700 Rev-AB

Product Safety Compliance International Electrotechnical Commission (IEC) IEC 60601-1 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 IEC 62133-2: 2017: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications 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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7309-120-700 Rev-AB

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Specifications Model:

STRYKER SYSTEM G Power Module

Catalog Number:

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, (Direct 12.6 V current) maximum

Capacity:

21.6 Wh

Lithium-ion Code:

3INR 19/65

Ingress Protection (IP):

IPX0

European Conformity:

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7309-120-700 Rev-AB

Homologaciones de seguridad de los productos International Electrotechnical Commission (IEC) IEC 60601-1 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 IEC 62133-2: 2017: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications 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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IT

7309-120-700 Rev-AB

Conformità di sicurezza del prodotto International Electrotechnical Commission (IEC) IEC 60601-1 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 IEC 62133-2: 2017: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications 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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PT

7309-120-700 Rev-AB

Conformidade da segurança do produto International Electrotechnical Commission (IEC) IEC 60601-1 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 IEC 62133-2: 2017: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications 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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TR

7309-120-700 Rev-AB

Ürün Güvenlik Uyumu International Electrotechnical Commission (IEC) IEC 60601-1 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 IEC 62133-2: 2017: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications 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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RU

7309-120-700 Rev-AB

Соответствие изделия требованиям по безопасности International Electrotechnical Commission (IEC) IEC 60601-1 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: 2014: EMC (Version 4.0) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests – Edition 4.0 IEC 62133-2: 2017: Secondary Cells and Batteries Containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells and for Batteries Made from Them for use in Portable Applications 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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