0406-900-702 Rev-E
EN
www.stryker.com
7
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, 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.
If additional information, especially safety information, or in-service training
is required, contact your Stryker sales representative or call Stryker
customer service.
User/Patient Safety
WARNINGS:
• Only trained and experienced healthcare professionals should use this
equipment.
• Before using any system component or any component compatible
with this system, read and understand the instructions. Pay special
attention to WARNING information. Become familiar with the handling
characteristics, the intended use(s) of this equipment, and system
components prior to use. Contact your Stryker sales representative or
customer service for in-service training.
• The healthcare professional performing any procedure is responsible
for determining the appropriateness of this equipment and the specific
technique for each patient. Stryker, as a manufacturer, DOES NOT
recommend surgical procedure.
• Upon initial receipt and before each use, operate the equipment and
inspect each component for damage. DO NOT use any component
if damage is apparent. Only trained and experienced healthcare
professionals should maintain this equipment. See the
Interventional
Spine (IVS) Care Instructions
.
• DO NOT use this equipment in areas in which flammable anesthetics or
flammable agents are mixed with air, oxygen or nitrous oxide.
• DO NOT use this equipment in the presence of endogenous gases.
• DO NOT use this equipment in the presence of cotton, wool or gauze
that is saturated with oxygen.
• Take special precautions regarding electromagnetic compatibility
(EMC) when using medical electrical equipment like this system. Install
and place this system into service according to the EMC information
contained in this manual. Portable and mobile RF communications
equipment can affect the function of this system.
• DO NOT use this equipment with patients having a cardiac pacemaker
or pacemaker electrodes unless otherwise directed by the cognizant
cardiology department.
WARNINGS:
• Patients taking steroids and patients with pacemakers, lupus, gout,
uncontrolled diabetes, Ehlers-Danlos syndrome, prior open capsular
procedures, autoimmune disease, or etiologies where their immune
systems are compromised require special consideration.
• To prevent a system failure that could delay surgery, DO NOT operate
the generator outside of its prescribed environmental conditions. See the
Specifications
section.
• Wipe away any potentially flammable liquids underneath the patient or in
body recesses or cavities before using the equipment.
• Apply dry gauze as required to avoid skin-to-skin contact between the
patient’s arms and body.
• DO NOT allow the patient to come in contact with metal parts that are
grounded or have a large capacitance with respect to ground (operating
table, supports). Use antistatic covers as required.
• When RF electro-surgical and physiological monitoring equipment
are used simultaneously on the same patient, position the monitoring
electrodes as far away from the surgical electrodes as possible,
especially if no protective resistors or RF chokes are present. DO NOT
use needle electrodes for monitoring.
• ALWAYS use patient monitoring systems that include high frequency
current limiting devices. Failure to comply may cause the patient
monitoring equipment to malfunction.
• DO NOT allow the leads to the surgical electrodes to touch the patient or
other leads.
• Place temporarily unused electrodes connected to the generator in
an electrically-insulated container. Never place an unused, connected
electrode on the patient.
• ALWAYS use parallel bipolar techniques for surgical procedures where
high frequency current could flow through parts of the body that have
a relatively small cross sectional area. Failure to comply may cause
undesirable tissue damage and result in patient injury.
Содержание RF MultiGen 0406-900-000
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