Safety Directives; Indications For Use - Stryker 0206-600-000 Instrucciones De Uso

Introduction
This instructions for use manual contains the information intended to
ensure the safe, effective, and compliant use of your product. This
manual is intended for 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.
For additional information, including safety information, in-service
training, or current literature, contact your Stryker sales representative
or call Stryker customer service. Outside the US, contact your
nearest Stryker subsidiary.

Indications For Use

The Dual Speed Cement Injection Gun is designed for use with
the Stryker High Vacuum Cement Injection System. The injection
gun is used to apply bone cement during total-hip and total-knee
arthroplasty.
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2017-06
Printed Date: Jul 03, 2018 22:39:49 GMT
0000003147, Rev. E Effective Date: Jul 21, 2017 11:19:40 AM
Dual Speed Cement Injection Gun

Safety Directives

WARNINGS:
▪ Before using this equipment, or any component compatible with
this equipment, read and understand the instructions for use. Pay
particular attention to safety information. Become familiar with the
equipment before use.
▪ Only healthcare professionals trained and experienced in the use
of this medical device should operate this equipment.
▪ 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.
▪ Upon initial receipt and before each use, clean and sterilize the
equipment as indicated. See the Processing Instructions section.
▪ Before using this cement gun in a clinical environment, practice
mixing bone cement and using the cement gun.
▪ DO NOT apply pressure in the femoral canal if the bone cement
might penetrate or flow uncontrollably into the femoral cortex,
arterial or venous system.
▪ The cartridge will not withstand the excessive pressure that
is created when doughy cement is extruded. DO NOT attempt
to extrude the cement if excessive force is necessary. In this
situation, remove the application tip and hand pack the cement.
Excessive force may cause the cartridge to break. Pieces of the
broken cartridge may cause patient and/or operating room staff
injury.
▪ Prepare the acetabulum to ensure the bone cement does not flow
into the pelvic cavity.
CAUTION: DO NOT repair this cement gun. In case of operating
difficulties, return to Stryker for repair.
0206-600-700 Rev-E
0206-600-000
Instructions For Use
www.stryker.com