Stryker Precision 6209-000-000 User manual

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Instructions For Use
6209-001-708 E

2015-06 6209-001-708 Rev-E www.stryker.com
Instructions For Use
ENGLISH (EN)
System 6
Stryker Precision®Oscillating Tip Saw
REF
6209-000-000

2 www.stryker.com
EN 6209-001-708 Rev-E
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.
Indications For Use
The Stryker Precision System is intended for use
in the cutting and shaping of bone and other bone
related tissue. The intended surgical applications are
orthopedic surgeries involving the shoulder, hip, knee,
and ankle.
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.
• 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.
• Upon initial receipt and before each use, clean and
sterilize the equipment as indicated. See the care
instructions manual supplied with the equipment.
• Perform recommended maintenance as indicated.
Only trained and experienced healthcare
professionals should maintain this equipment. See
the care instructions manual supplied with the
equipment.

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• ALWAYS operate the equipment within the
specified environmental condition values. See the
Specifications section.
• ALWAYS follow the recommended duty cycle to
prevent the equipment from overheating. See the
Specifications section.
• 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 the handpiece. Install and place
the handpiece into service according to the EMC
information in this manual. Portable and mobile RF
communications equipment can affect the function
of the handpiece.
Accessories
WARNINGS:
• 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.
• ALWAYS use a Stryker Precision Oscillating Tip Saw
Cartridge with this handpiece.
• 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.
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
System 6 Aseptic Battery
Kit, Large
6126-000-000
System 6 Battery Pack,
Large
6215-000-000
Precision Oscillating Tip
Saw Cartridges
6425-XXX-XXX series
6525-XXX-XXX series
Precision Falcon®
Oscillating Tip Saw
Cartridges
6625-XXX-XXX series
6720-XXX-XXX series
6725-XXX-XXX series

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EN 6209-001-708 Rev-E
Features
Handpiece
• Battery Latch - Depress the latch to release the battery pack from the handpiece.
• Battery Pack - Contains a rechargeable battery that provides power to the handpiece.
• Head - The head may be indexed in 45-degree increments and can turn in a complete 360-degree rotation to
achieve the desired cutting angle.
• Cartridge - Single use, disposable cutting accessory with a stationary bar component and oscillating cutting tip.
• Index Button - Press to rotate and orient the position of the head as desired.
• Wingnut - Used to secure the cartridge to the handpiece.
• Trigger Switch - The trigger is pressure sensitive for variable speed operation.
•FAST/STD/Safe Control - Based on its position, allows the handpiece to operate in the FAST or STD mode; the
safe mode position prevents inadvertent operation of the handpiece.
• Accessory Interface - Connector provides power and communication for future accessories.
• Applied Parts - The distal end of the handpiece and the cartridge (as defined by the standards listed in the
Specifications section under Product Safety Certification).
Wingnut
Cartridge
Trigger Switch
Battery Latch
Battery Pack
FAST/STD/Safe Control
Head
Index Button
Accessory Interface
Applied Parts

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FAST/STD/Safe Control
FAST Mode – Slide the FAST/STD/
Safe control to the FAST mode
position to allow the handpiece
to operate at high torque and
high speed when the trigger is
depressed.
STD Mode – Slide the FAST/STD/
Safe control to the STD (standard)
mode position to allow the
handpiece to operate at high torque
and standard speed when the trigger
switch is depressed.
Safe Mode – Slide the FAST/STD/
Safe control to the safe mode
position to lock the trigger and
prevent inadvertent operation of the
handpiece; the handpiece cannot be
operated.
Cartridge
NOTE: The incremental marks on the length of the cartridge are for
reference only.

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EN 6209-001-708 Rev-E
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
FAST Mode
STD Mode
CARTRIDGE LOCK
CARTRIDGE UNLOCK
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.
Instructions
WARNING: ALWAYS place the FAST/STD/Safe
control in the safe mode position while the
handpiece is idle, before installing or removing
any accessory or battery pack, or when passing
the handpiece to another person.
To Install the Cartridge
WARNING: ALWAYS install the cartridge with the
FULL INSERT marking visibly facing up. Failure
to comply may result in product damage and
patient and/or healthcare staff injury.
1. Slide the FAST/STD/Safe control to the safe mode
position.
2. Rotate the wingnut to the UNLOCK position.
3. With the FULL INSERT marking visibly facing up,
install the cartridge onto the head by aligning the
blade rod ends with the drive pins on the head (see
figure 1).

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Cartridge
Wingnut
Drive
Pins (2)
Head
Blade
Rod Ends
Post
Keyhole
Tabs (2)
Figure 1 – To Install Cartridge
4. With the drive pins engaged in the rod ends, pull the
cartridge away from the handpiece until the cartridge
drops down onto the surface of the head. The post
will pass through the large opening in the cartridge
keyhole.
5. Guide the cartridge as it springs back toward the
handpiece. Make sure the post is aligned with the
FULL INSERT mark (see figure 2). The cartridge
should be fully seated under the tabs on the head.
Figure 2 – Align Post with FULL INSERT mark
6. Rotate and align the wingnut dot with the LOCK
symbol to secure the cartridge (see figure 3).
Figure 3 – Rotate Wingnut to Lock

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EN 6209-001-708 Rev-E
To Index Sagittal Head
CAUTION: Before operating the handpiece, ensure the
sagittal head is locked into position. Failure to comply
may result in product damage.
NOTE: The sagittal head has eight possible cutting
angle positions (45-degree increments).
1. Push and hold the index button; rotate the sagittal
head to the desired cutting angle (see figure 4).
Index Button
Figure 4 – Push Button To Allow Head Rotation
2. Once the sagittal head is positioned, release the
index button, and gently turn the sagittal head to
ensure it is locked into position.
To Install Battery Pack
NOTES:
• This handpiece is designed to accept the Stryker
Large Battery Pack (REF 6215-000-000) only.
This battery pack can be charged in the Stryker
System 6 Battery Charger (REF 6110-120-000) or
the Universal Battery Charger (REF 7110-120-000)
configured with the appropriate battery charger
module.
• See the instructions for use supplied with the battery
charger and/or battery pack for charging details and
specifications.
1. Slide a fully charged battery pack firmly into the
handpiece until the battery latch snaps, indicating
the pack is secure (see figure 5).
Battery Latch
Figure 5 – Install Battery Pack
2. Test the operation of the handpiece by sliding the
FAST/STD/Safe control to either the FAST or STD
mode position and squeezing the trigger.
3. Slide the FAST/STD/Safe control to the safe mode
position until you are ready to use the handpiece.

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1. Ensure the drive pins are free from all obstructions
during operation (see figure 6).
Drive
Pins
Figure 6 – Drive Pin Clearance
2. Slide the FAST/STD/Safe control to the FAST or STD
mode position to allow the handpiece to operate.
3. Squeeze the pressure sensitive trigger for variable
speed operation.
4. Slide the FAST/STD/Safe control to the safe mode
position when you are finished operating the
handpiece.
To Operate Handpiece
WARNINGS:
• ALWAYS place the FAST/STD/Safe control in the
safe mode position while the handpiece is idle,
before installing or removing any accessory, or when
passing the handpiece to another person.
• DO NOT place a hand on the drive pins located on
the blade mount of the handpiece. Friction between
the drive pins and hand may create heat.
• DO NOT apply excessive pressure, such as bending
or prying, with a cutting accessory to prevent
fracturing and/or excessively heating the accessory.
CAUTIONS:
• DO NOT stall the handpiece. Failure to comply may
damage the electric motor and/or battery pack. If
the handpiece jams, release the trigger immediately.
Remove any obstructions before continuing the
procedure.
• If any power loss is experienced while using a
handpiece, ALWAYS replace the battery pack with
a fully charged battery pack. Failure to comply may
result in a drained or damaged battery pack with a
shortened life.

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EN 6209-001-708 Rev-E
To Remove/Dispose of Cartridge
WARNING: ALWAYS place the FAST/STD/
Safe control in the safe mode position before
attaching or removing any accessory to prevent
inadvertent running of the handpiece.
1. Slide the FAST/STD/Safe control to the safe mode
position.
2. To unlock the cartridge, rotate the wingnut to the
UNLOCK position. Pull the cartridge away from the
head and lift the cartridge away from the handpiece
(see figure 1).
3. Properly dispose of the single use cartridge.
Battery Pack Removal
Depress the battery latch and pull the battery pack out
of the handpiece.
Care Instructions
For processing instructions and disposal/recycle
information, see the care instructions manual supplied
with the equipment.

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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
oscillates at a reduced speed
making cutting difficult.
Battery pack is discharged. Recharge the battery pack in Stryker
charger.
Battery pack is expended. Replace the battery pack.
FAST/STD/Safe control is in the safe
mode position.
Slide the FAST/STD/Safe control to the
FAST or STD mode position.
Cartridge is malfunctioning. Replace the cartridge.
Drivetrain is malfunctioning. Return the handpiece for repair.
Motor runs but cartridge does
not move.
Drivetrain is malfunctioning. Return the handpiece for repair.
Cartridge is malfunctioning. Replace the cartridge.
Battery pack becomes
unusually hot during use.
Circuitry is malfunctioning. Check the battery pack on the Stryker
charger and replace the battery pack
if required. See the instructions for use
supplied with the battery charger.
Handpiece has become noisy
and vibrates.
Cartridge is not fully seated. Reseat the cartridge.
Cartridge is malfunctioning. Replace the cartridge.
Drivetrain is malfunctioning. 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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EN 6209-001-708 Rev-E
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: System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000)
Dimensions: 8.9 inch [226 mm] height (with large battery pack)
1.6 inch [41 mm] width
7.2 inch [183 mm] length
Mass: 3.6 lb [1.63 kg] (with large battery pack)
Speed: 10,000 cycles per minute (STD mode); 12,000 cycles per minute (FAST mode)
Excursion: 12-degree arc
Mode of Operation:
Duty Cycle:
Rest Between Cycles:
Non-Continuous Operation
1 minute on/4 minutes off, 5 times
3 hours
Equipment Type:
Type BF Applied Part
Maximum Temperature
of Applied Parts:
Less than 124 °F [51 °C] (Maximum surface temperature as tested to the standards
listed under Product Safety Certification.)
Power Supply: Internally Powered 9.6 V (Direct current)
Ingress Protection: IPX0 Ordinary Equipment

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Product Safety
Certification: CSA International
International Electrotechnical Commission
IEC 60601-1:2005, Medical Electrical Equipment — Part 1: General Requirements
for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC
Corrigendum 2 (2007)
IEC 60601-1:1988, Medical Electrical Equipment — Part 1: General Requirements for
Safety - Second Edition; Amendment 1 (1991); Amendment 2 (1995); Corrigendum
1 (1995)
Canadian Standards Association
CAN/CSA-C22.2 No. 60601-1:08, Medical Electrical Equipment — Part 1: General
Requirements for Basic Safety and Essential Performance
CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment — Part 1: General
Requirements for Safety
American National Standards Institute / Association for the Advancement of Medical
Instrumentation
ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment — Part 1: General
Requirements for Basic Safety and Essential Performance; Consolidated Reprint
(2009); Amendment 2 (2010)
Underwriters Laboratories
UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety —
First Edition; Revisions through and including April 26, 2006
European Committee for Electrotechnical Standardization (CENELEC)
EN 60601-1:2006, Medical Electrical Equipment — Part 1: General Requirements
for Basic Safety and Essential Performance; IEC Corrigendum 1 (2006); IEC
Corrigendum 2 (2007); CENELEC Corrigendum (2010)

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EN 6209-001-708 Rev-E
Environmental Conditions: Operation Storage and Transportation
Temperature Limitation:
Humidity Limitation:
Atmospheric Pressure
Limitation:
Guidance and manufacturer's declaration - electromagnetic emissions
The System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 6 Stryker Precision Oscillating Tip Saw (REF
6209-000-000) should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The System 6 Stryker Precision Oscillating Tip Saw (REF 6209-
000-000) uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B The System 6 Stryker Precision Oscillating Tip Saw (REF 6209-
000-000) is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
N/A
Specifications (continued)

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Guidance and manufacturer's declaration - electromagnetic immunity
The System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 6 Stryker Precision Oscillating Tip Saw (REF
6209-000-000) should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
± 6 kV
contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast transient/
burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
N/A N/A
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth N/A N/A
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT)
for 0,5 cycle
N/A N/A
40 % UT(60 % dip in UT)
for 5 cycles
70 % UT(30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 sec
Power frequency (50/60
Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE: UTis the alternating current mains voltage prior to application of the test level.

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EN 6209-001-708 Rev-E
Guidance and manufacturer's declaration - electromagnetic immunity
The System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 6 Stryker Precision Oscillating Tip Saw (REF
6209-000-000) should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
N/A
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the System 6
Stryker Precision Oscillating Tip Saw (REF 6209-000-000),
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d= 1.2√P 80 MHz to 800 MHz
d= 2.3√P 800 MHz to 2,5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic site
surveya, should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment marked
with the following symbol:
(Non-ionizing electromagnetic radiation)
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the System 6 Stryker Precision
Oscillating Tip Saw (REF 6209-000-000) is used exceeds the applicable RF compliance level above, the System 6 Stryker Precision Oscillating Tip Saw
(REF 6209-000-000) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000).
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between portable and mobile RF communications equipment and the
System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000)
The System 6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000) is intended for use in the electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the System 6 Stryker
Precision Oscillating Tip Saw (REF 6209-000-000) can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the System
6 Stryker Precision Oscillating Tip Saw (REF 6209-000-000) as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHz
d= 1.2√P
800 MHz to 2,5 GHz
d= 2.3√P
0,01 N/A 0.12 0.23
0,1 N/A 0.38 0.73
1 N/A 1. 2 2.3
10 N/A 3.8 7.3
100 N/A 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.