Stryker Electric System 6 User manual

2019-09 6297-001-700 Rev-AB www.stryker.com
Instructions For Use
ENGLISH (EN)
Electric System 6™
Sternum Saw
6297-000-000

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EN 6297-001-700 Rev-AB
Indications For Use
The Stryker Electric System 6 Heavy Duty Sternum
Saw is used with the Consolidated Operating Room
Equipment (CORE™) System. The saw is a linear cutting
device used for cutting bone and bone related tissue
including the sternum.
Contraindications
None known.
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 particular attention to WARNING
information. Become familiar with the system
components prior to use.
• 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.
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.
For additional information, especially safety information,
or in-service training, contact your Stryker sales
representative or call Stryker customer service. Outside
the US, contact your nearest Stryker subsidiary.
NOTE: The user and/or patient should report any serious
product-related incident to both the manufacturer and
the Competent Authority of the European Member State
where the user and/or patient is established.

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• 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.
• Perform recommended maintenance as indicated.
Only trained and experienced healthcare
professionals should maintain this equipment. See
the care instructions manual supplied with the
equipment.
• Upon initial receipt and before each use, clean and
sterilize the equipment as indicated. See the care
instructions manual supplied with the equipment.
• DO NOT use this equipment in areas in which
flammable anesthetics or flammable agents are
mixed with air, oxygen, or nitrous oxide.
• ALWAYS place the handpiece in the safe mode
position while the handpiece is idle, before installing
or removing any accessory, and when passing the
handpiece to another person.
• ALWAYS operate the equipment within the
specified environmental condition values. See the
Specifications section.
Accessories
WARNING: Use only Stryker-approved
system components and accessories, unless
otherwise specified. Using other accessories
may result in increased electromagnetic
emissions or decreased electromagnetic
immunity of the system. DO NOT modify any
system component or accessory.
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.
The following Stryker-approved accessories are sold
separately:
DESCRIPTION REF
Handpiece Cord 6292-004-000

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EN 6297-001-700 Rev-AB
Blades
WARNINGS:
• DO NOT reuse, reprocess, or repackage single use
cutting accessories. All cutting accessories are
intended for a single use only. Reuse may create a
serious risk of contamination and lead to infection
or cross-infection. Reprocessing may compromise
the structural integrity of the cutting accessory and
result in fragmentation during use. Critical product
information may be lost if the cutting accessory is
repackaged.
• Upon initial receipt and before use, visually inspect
the package for damage to confirm the integrity of
the sterile barrier. Do not use the product if damage
is apparent, the sterile barrier is compromised, or the
package is unintentionally opened.
NOTE: Sterile cutting accessories are sterilized by
irradiation.
DESCRIPTION REF
Sternum Blade, Offset 0296-097-102
0298-097-100
0298-097-101
0298-097-104
Stryker Performance Series®
Sternum Blade
6207-097-101
Sternum Blade Guard 4107-008-000
7207-002-000
7207-003-000

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Features
Handpiece
•Cord Latch - To release the handpiece cord from the handpiece, press the latch.
•Cord Connector - Install the handpiece cord into this connector.
• Run/Safe Control - The run mode position allows the handpiece to operate. The safe mode position prevents
inadvertent operation of the handpiece.
• Blade Collar - The spring-loaded blade collar allows the insertion and release of the blade.
• Blade - The blade teeth may be directed in one of two positions. The teeth must always be directed away from the
sternum blade guard.
• Sternum Blade Guard - Protects soft tissue from coming into contact with the blade.
• Guard Actuating Knob - To release the sternum blade guard, push on knob with a circular motion.
• Trigger - The trigger is pressure sensitive for variable speed operation.
•Applied Part - The distal end of the handpiece and the sternum blade guard (as defined by the Product Safety
Certification standards listed in the Specifications section of the instructions for use supplied with the console).
Cord Connector
Trigger
Sternum Blade Guard
Blade Collar
Guard Actuating Knob
Run/Safe Control
Cord Latch Blade
Applied Part

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EN 6297-001-700 Rev-AB
Run/Safe Control
Run Mode – Slide the run/safe control to either run
mode position (two available) to allow the handpiece to
operate while the trigger is depressed.
Safe Mode – Slide the run/safe control to the safe
mode position to lock the trigger and prevent inadvertent
operation of the handpiece; the handpiece cannot be
operated.
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
Run Mode/Safe Mode
General warning sign
Per European Union Directive 2012/19/EU, product must be collected separately. Do not
dispose of as unsorted municipal waste. Contact local distributor for disposal information.

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Instructions
To Install Cutting Accessory
WARNING: To prevent the inadvertent running
of the handpiece, ALWAYS place the run/
safe control in the safe mode position before
installing or removing any accessory.
1. Slide the run/safe control to the safe mode position.
2. Rotate the spring-loaded blade collar clockwise
aligning the slots. Insert the blade (see figure 1).
NOTE: The blade teeth may be directed in one of two
positions. When using the sternum blade guard, the teeth
must point away from the sternum blade guard.
Figure 1 – To Install Blade
3. Release the blade collar. Ensure the blade collar
springs back to its original position indicating the
blade is properly seated.
4. Gently tug the cutting accessory to ensure it is
secure.
To Install Sternum Blade Guard
WARNING: DO NOT allow the blade to retract
or extend from the end of the sternum blade
guard.
NOTE: The sternum blade guard may be installed in the
orientation shown in figure 2 or rotated 180 degrees.
ALWAYS orient the sternum guard such that the blade
teeth point away from the guard as illustrated.
Knob on Collar
Figure 2 – To Install Sternum Blade Guard
1. Push against the guard actuating knob to rotate the
collar. Install the sternum blade guard over the blade
ensuring the blade’s teeth are pointed away from the
guard. Release the guard actuating knob to allow the
spring-loaded collar to snap back and lock sternum
blade guard in place.
2. Gently tug the sternum blade guard to ensure that it
is secure.
3. Visually inspect the blade and sternum blade guard
to ensure the blade neither retracts nor extends from
the sternum blade guard.

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EN 6297-001-700 Rev-AB
To Operate Handpiece
WARNINGS:
• ALWAYS place the run/safe control in the safe mode
position while the handpiece is idle, before installing
or removing an accessory, and when passing the
handpiece to another person.
• DO NOT operate the handpiece until the blade is
in contact with bone or tissue. Failure to comply
may cause the blade to break or eject from the
handpiece.
• While operating the handpiece, DO NOT grasp the
handpiece near the guard actuating knob or cause
the knob to move. Moving the knob during operation
may cause the sternum blade guard to disengage.
Failure to comply may cause the loss of tactile
control.
• DO NOT apply excessive pressure, such as
bending or prying, with a cutting accessory
to prevent fracturing the accessory. Applying
excessive pressure, especially during high operating
speeds, may cause the cutting accessory to bend
significantly and result in tissue damage, loss of
tactile control and the ejection of cutting accessory
pieces at a high velocity.
• ALWAYS follow the recommended duty cycle to
prevent the equipment from overheating. See the
Specifications section.
CAUTIONS:
• When operating the handpiece, let the blade do the
cutting. Applying too much pressure will bend the
blade and reduce the cutting quality.
• DO NOT stall the handpiece. Failure to comply
may damage the electric motor. If the handpiece
jams, release the trigger immediately. Remove any
obstructions before continuing the procedure.
1. Slide the run/safe control to the safe mode position.
2. Insert the handpiece cord into cord connector of the
handpiece until the connector latch engages. An
audible click should be heard. Gently tug on the cord
to ensure that the cord is secure.
3. Connect the other end of the handpiece cord to the
console.
4. At the console, program the operational settings of
the handpiece as required. See the instructions for
use supplied with the console.
5. Slide the run/safe control to either run position to
allow the handpiece to operate.
6. Squeeze the pressure-sensitive trigger for variable
speed operation.
7. Slide the run/safe control to the safe mode position
when you are finished operating the handpiece.

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To Remove Handpiece Cord
Press the cord latch and pull the handpiece cord out of
the handpiece.
To Remove Sternum Blade Guard
1. Slide the run/safe control to the safe mode position.
2. Push against the guard actuating knob to rotate the
collar. Remove the sternum blade guard from the
handpiece. Release the guard actuating knob to
allow the spring-loaded collar to snap back to its
original position.
To Remove Cutting Accessory
1. Slide the run/safe control to the safe mode position.
2. Rotate the spring-loaded blade collar clockwise to
realign the slots and remove the blade.
Care Instructions
For processing instructions and disposal/recycle
information, see the care instructions manual supplied
with the equipment.

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EN 6297-001-700 Rev-AB
Troubleshooting
WARNING: DO NOT disassemble or service this equipment.
NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US,
contact your nearest Stryker subsidiary.
PROBLEM CAUSE ACTION
Handpiece does not run or
reciprocates at a reduced speed
making cutting difficult.
Handpiece cord is not properly
connected.
Reconnect the handpiece cord
between the handpiece and console.
Handpiece cord is damaged. Return the handpiece cord for repair.
Run/safe control is in the safe
mode position.
Slide the run/safe control to the run
mode position.
Handpiece is damaged. Return the handpiece for repair.
Motor runs but blade does not move. Handpiece is damaged. Return the handpiece for repair.
Blade will not fit into the blade collar. Debris is inside the end of the
blade collar.
Clean the handpiece with a small
brush.
Blade collar is damaged. Return the handpiece for repair.
Blade collar does not spring back to
retain the blade.
Debris is inside of blade collar. Clean the handpiece with small brush.
Actuate the blade collar several times
to obtain smooth operation.
Sternum blade guard will not fit into
the handpiece.
Debris is inside of the blade guard
retainer.
Clean the handpiece with a small
brush.
Sternum blade guard is damaged. Replace the sternum blade guard.
Handpiece has become noisy and
vibrates.
Handpiece is damaged. Return the handpiece for repair.
Sporadic electrical interference is
experienced.
Electrical noise is present. Turn off all electrical equipment not in
use in the operating room.
Relocate electrical equipment;
increase spatial distance.
Plug operating room equipment into
different operating room outlets.

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Specifications
WARNING: ALWAYS check any documentation that accompanies attachments, burs, pins, and/or blades for
special duty cycle and usage instructions.
NOTE: Specifications are approximate and may vary between devices or as a result of power supply fluctuations.
Model: Electric System 6 Sternum Saw (REF 6297-000-000)
Dimensions: 5.6 inch [142 mm] height
1.49 inch [38 mm] width
7 inch [178 mm] length (without sternum blade guard)
Mass: 2.20 lb [1.00 kg] (without sternum blade guard)
Speed: 14,000 cycles per minute
Excursion: 0.152 inch [3.9 mm]
Mode of Operation:
Duty Cycle:
Rest Between Cycles:
Non-continuous Operation
1 minute on/4 minutes off, 5 times
3 hours
Power Supply: Externally supplied (CORE console REF 5400-050-000) (CORE 2 console REF 5400-
052-000)
Ingress Protection: IPX0 Ordinary Equipment
Maximum Temperature
of Applied Part:
Less than 124 °F [51 °C] (Maximum surface temperature as tested to the standards
listed under Product Safety Certification in the instructions for use supplied with the
console.)
Environmental
Conditions:
Operation Storage and Transportation
Temperature Limitation:
Humidity Limitation:
Atmospheric Pressure
Limitation:

2019-09 6297-001-700 Rev-AB www.stryker.com
Stryker Instruments
1941 Stryker Way
Portage, Michigan
(USA) 49002
1-269-323-7700
1-800-253-3210
ES/DE/FR/IT/NL 6297-001-710
JA/ZH/KO 6297-001-720
SV/DA/FI/PT/NO 6297-001-730
PL/EL 6297-001-750