Stryker SYSTEM G 7309-120-000 User manual

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)

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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

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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.

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Features
A
B
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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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.

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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:

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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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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