Stryker SYSTEM G 7309-120-000 Bedienungsanleitung

2016-06 7309-120-700 Rev-B www.stryker.com

Instructions For Use

STRYKER SYSTEM G™

Power Module

7309-120-000

ENGLISH (EN)

ESPAÑOL (ES)

ITALIANO (IT)

PORTUGUÊS (PT)

TÜRKÇE (TR)

РУССКИЙ (RU)

中文 (ZH)

한국어 (KO)

2 www.stryker.com

EN 7309-120-700 Rev-B

Introduction

This instructions for use manual contains

information intended to ensure the safe, effective,

and compliant use of your product.

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.

Contents

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

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

Storage and Handling. . . . . . . . . . . . . 7

Disposal/Recycle . . . . . . . . . . . . . . . 7

Specifications . . . . . . . . . . . . . . . . 8

Product Safety Compliance . . . . . . . . . . 9

7309-120-700 Rev-B EN

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Contact 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.

Indications For Use

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.

Contraindications

None known.

For Use With

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

STRYKER SYSTEM G

Reciprocating Saw

7306-001-000

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

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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EN 7309-120-700 Rev-B

Safety Directives

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.

▪ 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.

7309-120-700 Rev-B EN

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Features

A Handle – Used to insert and remove

the power module from the handpiece.

B Battery Contacts – Interlock with the

battery charger to complete an electric

circuit.

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

DO NOT

STERILIZE Do not sterilize

Consult instructions for use

Universal Recycling Symbol

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EN 7309-120-700 Rev-B

Symbol Definition

1 V 1 Volt

1 A 1 Ampere

1 VA 1 Volt Ampere

1 Hz 1 Hertz

AC Alternating Current

REF Catalog Number

Care Instructions

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.

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.

7309-120-700 Rev-B EN

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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.

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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EN 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: 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, 12.6 V

(Direct current) maximum

Capacity: 21.6 Wh

Lithium-ion

Code: 3INR 19/65

Ingress

Protection (IP): IPX0

European

Conformity:

7309-120-700 Rev-B EN

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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 Non-

Acid 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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ES 7309-120-700 Rev-B

Introducción

Este manual de instrucciones de uso contiene

información concebida para asegurar el uso seguro,

eficaz y conforme a las normativas del producto.

Destinatarios

Este manual está dirigido a formadores internos

del centro, médicos, enfermeros y técnicos

quirúrgicos. Conserve y consulte este manual de

referencia durante toda la vida del producto.

Convenciones

Este manual utiliza las siguientes convenciones:

▪ Una ADVERTENCIA destaca un problema

relacionado con la seguridad. Cumpla

SIEMPRE esta información para evitar

lesiones al paciente o al personal sanitario.

▪ Una PRECAUCIÓN destaca un problema de

fiabilidad del producto. Cumpla SIEMPRE esta

información para evitar daños al producto.

▪ Una NOTA complementa o aclara la

información de un procedimiento.

Contenido

Introducción . . . . . . . . . . . . . . . . . 2

Destinatarios . . . . . . . . . . . . . . 2

Convenciones . . . . . . . . . . . . . 2

Información de contacto . . . . . . . . . 3

Indicaciones de uso . . . . . . . . . . . . . 3

Contraindicaciones . . . . . . . . . . . . . . 3

Para uso con. . . . . . . . . . . . . . . . . 3

Directivas de seguridad . . . . . . . . . . . . 4

Características . . . . . . . . . . . . . . . . 5

Definiciones . . . . . . . . . . . . . . . . . 5

Instrucciones para el cuidado . . . . . . . . . 6

Instrucciones. . . . . . . . . . . . . . . . . 6

Almacenamiento y manipulación . . . . . . . 7

Eliminación y reciclaje . . . . . . . . . . . . 7

Especificaciones . . . . . . . . . . . . . . . 8

Homologaciones de seguridad de los productos 9

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