Indications For Use - Stryker 0210-000 Serie Manual De Instrucciones

EN
Introduction
This Instructions For Use manual is the most comprehensive source of information
for the safe and effective use of your product. This manual may be used by in-
service trainers, physicians, nurses, and surgical technologists.
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.
If additional information, especially safety information, or in-service training is
required, contact your Stryker sales representative or call Stryker customer
service.
Trademarks not the property of Stryker Corporation are the property of their
respective owners.

Indications For Use

The Stryker InterPulse Irrigation System is used for wound debridement, soft
tissue debridement, and cleansing of medical, clinical, or surgical sites. This
includes cleansing of bone in surgical procedures, hydrodebridement of chronic
wounds, debridement of loose skin from burns, and the cleansing of trauma
wounds.
Contraindications
None known.
For Use With
This section describes system components that must be used with the equipment
described in this manual to create a safe and effective system. The InterPulse
Rechargeable Power Pack Handpiece requires the following system components:
DESCRIPTION
InterPulse Rechargeable Power Pack
InterPulse Power Pack Charger
All InterPulse handpieces require the following system components:
DESCRIPTION
InterPulse Tips or Wound Care Replacement Sets
Stryker IV Pole (or equivalent)
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Print Date: Nov 02, 2016 02:57:27 PM
0000004059, Rev. T Effective Date: Sep 26, 2016 2:47:57 PM
User/Patient Safety
• Before using any system component, or any component compatible with
this system, read and understand the instructions. Pay particular attention to
WARNING information. Become familiar with the system components prior to
use.
• Only trained and experienced healthcare professionals should use this
equipment.
• Upon initial receipt, inspect the packaging and each component for damage.
DO NOT use any equipment if damage is apparent or the sterile barrier has
been compromised. See the Inspection and Testing section for inspection
criteria.
• The healthcare professional performing any procedure is responsible for
determining the appropriateness of this equipment and the specific technique
used for each patient. Stryker, as a manufacturer, does not recommend
surgical procedure or technique.
• DO NOT use this equipment in areas in which flammable anesthetics or
flammable agents are mixed with air, oxygen or nitrous oxide.
• Take special precautions regarding electromagnetic compatibility (EMC) when
using medical electrical equipment like this system. Install and place the
system into service according to the EMC information in this manual. Portable
and mobile RF communications equipment can affect the function of the
system. See the Specifications section.
Accessories
This section describes system components that may be ordered to replace
original equipment that is damaged, worn, or must be replaced. This section may
also contain optional components used with the system.
• Use only Stryker-approved system components and accessories, unless
otherwise specified.
• Using other electronic components and accessories may result in increased
REF
electromagnetic emissions or decreased electromagnetic immunity of the
0211-022-000
system.
0211-024-000 • DO NOT modify any system component or accessory.
• DO NOT reuse, reprocess, or repackage a single use device. A single use
device is intended for a single use only. A single use device may not withstand
chemical, chemical vapor, or high temperature sterilization reprocessing.
REF
Design features may make cleaning difficult. Reuse may create a serious risk
0210-XXX-XXX Series
of contamination and may compromise the structural integrity of the single use
device resulting in operational failure. Critical product information may be lost if
0296-003-000
the single use device is repackaged. Failure to comply may lead to infection or
cross-infection and result in patient and/or healthcare staff injury.
The following Stryker-approved accessories are sold separately:
DESCRIPTION
InterPulse Tips, sterile, disposable, 12 per package
InterPulse Splash Shields, sterile, disposable, 12 per
package
InterPulse Wound Care Replacement Sets, sterile,
disposable, 12 per package
IV Pole
NOTE: For a complete list of accessories, contact your Stryker sales
representative or call Stryker customer service. Outside the US, contact your
nearest Stryker subsidiary.
WARNINGS:
WARNINGS:
0210-100-700 Rev-T
REF
0210-0XX-X00 Series
0210-034-000
0210-31X-X00 Series
0296-003-000
www.stryker.com