Stryker System 6 6203-000-000 User manual

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Instructions For Use
6203-001-700 E

2015-03 6203-001-700 Rev-E www.stryker.com
System 6
Single Trigger Rotary Handpiece
6203-000-000
Instructions For Use
ENGLISH (EN)

2 www.stryker.com
EN 6203-001-700 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 System 6 Battery Powered Heavy Duty
Single Trigger Rotary Handpiece, when used with
a variety of attachments, is intended for surgical
procedures involving drilling, reaming, driving wire or
pins, cutting bone and hard tissue.
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.

6203-001-700 Rev-E EN
www.stryker.com 3
▪ 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 and/or the instructions for
use supplied with the attachment.
▪ 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.
▪ 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
Small Battery Pack 6212-000-000
Large Battery Pack 6215-000-000
Aseptic Battery Kit 6126-000-000
Small Aseptic Battery Kit 6127-000-000

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EN 6203-001-700 Rev-E
Features
Handpiece
▪ Battery Latch - To release the battery pack from the handpiece, depress the battery latch.
▪ Battery Pack - Rechargeable battery pack provides power to the handpiece.
▪ Trigger Switch - To cause rotation and vary speed, press this pressure-sensitive trigger.
▪ F/R/Safe Control - Based on its position, allows the handpiece to operate in forward or reverse mode; the
safe mode position prevents the inadvertent operation of the handpiece.
▪ Actuating Collar - To release the attachment, slide the actuating collar.
▪ Shifter Knob - To select the handpiece mode of REAM (slow) or DRILL (fast), rotate the knob to the
appropriate position, as required.
▪ Accessory Interface - Connector provides power and communication for future accessories.
▪ Attachment - A variety of attachments are available for use with this handpiece. Each attachment has a
specialized retainer for wires, pins, tools and/or cutting accessories.
▪ Applied Parts - The distal end of the handpiece and the attachment (as defined by the standards listed in
the Specifications section under Product Safety Certification).
Battery Latch
Battery Pack
Trigger Switch
Actuating Collar
Attachment
Applied Parts
Shifter Knob
F/R/Safe Control
Accessory Interface

6203-001-700 Rev-E EN
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F/R/Safe Control
Forward Mode – Slide the F/R/
Safe control to the forward mode
position to allow the handpiece to
run clockwise while the trigger is
depressed.
Reverse Mode – Slide the F/R/Safe
control to the reverse mode position
to allow the handpiece to run
counterclockwise while the trigger is
depressed.
Safe Mode – Slide the F/R/Safe
control to the safe mode position to
prevent inadvertent operation of the
handpiece – the handpiece cannot
be operated.
Shifter Knob
DRILL Mode – For fast speed and
low torque, rotate shifter knob to
DRILL.
REAM Mode – For slow speed and
high torque, rotate shifter knob to
REAM.
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 SYMBOL DEFINITION
Forward Mode DRILL
Reverse Mode REAM
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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EN 6203-001-700 Rev-E
3. Once properly aligned, insert the attachment into
the handpiece until the attachment “snaps” into
place.
4. Tug the attachment to ensure it is secure.
5. Install the desired cutting accessory. See the
instructions for use manual for the attachment.
To Install Battery Pack
NOTES:
▪ This handpiece is designed to accept a Stryker
Large or Small Battery Pack only (REF 6215-000-
000 or REF 6212-000-000). These battery packs
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 modules.
▪ See the instructions for use supplied with the
battery charger and/or battery pack for charging
details and specifications.
Instructions
To Install Attachment
WARNING: To prevent inadvertent
running of the handpiece, ALWAYS place
the F/R/Safe control in the safe mode
position before installing or removing any
attachment.
NOTE: Several attachments are available and each
has a specialized accessory retainer.
1. Slide the F/R/Safe control to the safe mode
position.
2. To install an attachment, align the driveshaft of
the attachment with the handpiece spindle. If the
attachment has notches, also align the notches
with the tabs in the sleeve of the handpiece (see
figure 1).
Driveshaft
Tabs
Notches
(not always
present)
Figure 1 – To Install Attachment

6203-001-700 Rev-E EN
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1. Slide a fully charged battery pack firmly into the
handpiece until the battery latch snaps, indicating
the battery pack is secure (see figure 2).
Figure 2 – To Install Battery Pack
2. Test the operation of the handpiece by sliding the
F/R/Safe Control to FORWARD (F) or REVERSE
(R) and squeezing the trigger.
3. Slide the F/R/Safe control to the safe mode
position until you are ready to use the handpiece.
To Operate Handpiece
WARNINGS:
▪ ALWAYS place the F/R/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.
▪ Ensure the F/R/Safe control DOES NOT change
position, for example, forward to reverse, while the
handpiece is operating.
▪ A wobbling attachment may cause bone or tissue
damage or inaccurate wiring or pin placement. If
wobbling occurs, see the Troubleshooting section.
▪ 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.
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.
1. Slide the F/R/Safe control to the appropriate
position to allow the handpiece to operate in the
forward or reverse mode.
2. Squeeze the pressure sensitive trigger for variable
speed operation.
3. Slide the F/R/Safe control to the safe mode
position when you are finished operating the
handpiece.

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EN 6203-001-700 Rev-E
▪ For REAM mode, rotate the shifter knob
clockwise until it clicks in place.
3. Test the operation of the handpiece.
4. Slide the F/R/Safe control to the safe mode
position until you are ready to use the handpiece.
To Remove Attachment
1. Slide the F/R/Safe control to the safe mode
position.
2. Slide the actuating collar back to release the
attachment.
To Remove Battery Pack
Depress the battery latch and pull the battery pack out
of the handpiece.
To Change Handpiece Mode
WARNINGS:
▪ DO NOT change the handpiece mode while
operating the handpiece.
▪ DO NOT use a reamer in the handpiece and
operate the handpiece in the DRILL mode. Failure
to comply may cause wobble and result in patient
and/or healthcare staff injury.
1. Ensure the handpiece is not running.
2. Change the handpiece mode as follows:
▪ For DRILL mode, rotate the shifter knob
counterclockwise until it clicks in place.
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
turns at a reduced speed.
Battery pack is discharged. Recharge the battery pack in Stryker battery
charger.
Battery pack is expended. Replace the battery pack.
F/R/Safe control is in the safe mode
position.
Slide F/R/Safe control to the forward or
reverse mode position.
Drivetrain is malfunctioning. Return the handpiece for repair.

6203-001-700 Rev-E EN
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PROBLEM CAUSE ACTION
Motor runs but cutting
accessory does not move.
Drivetrain is malfunctioning. Return the handpiece for repair.
Attachment is not fully seated. Remove and insert the attachment. Ensure the
attachment is fully seated.
Shifter knob is positioned between
the DRILL and REAM selections.
Position shifter knob to either the DRILL or
REAM position.
Battery pack becomes
unusually hot during use.
Circuitry is malfunctioning. Check the battery pack on the charger.
Replace the battery pack if required. See the
instructions for use supplied with the battery
charger.
Attachment will not fit into
the handpiece.
Debris is on the attachment
or inside the front end of the
handpiece.
Clean the attachment and/or handpiece with a
small brush with stiff, non-metallic bristles.
Attachment is damaged. Return the attachment for repair.
Handpiece is damaged. Return the handpiece for repair.
Attachment and/or cutting
accessory wobbles in
handpiece.
Cutting accessory or wire/pin is
bent, extends too far from the distal
end of attachment, is the wrong
size, or is not properly centered in
the attachment.
Reinsert the cutting accessory, wire or pin.
If wobble persists, return the handpiece and
attachment for repair.
A reamer is installed and the
handpiece is in the DRILL mode.
ALWAYS operate a reamer in the REAM mode.
Handpiece has become
noisy and vibrates.
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 6203-001-700 Rev-E
Care Instructions
For processing instructions and disposal/recycle information, see the care instructions manual supplied with the
equipment.
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 Single Trigger Rotary Handpiece (REF 6203-000-000)
Dimensions: 8.6 inch [219 mm] height (with large battery pack)
1.5 inch [38 mm] width
6.0 inch [153 mm] length
Mass: 3.5 lb [1.6 kg] (with large battery pack)
Speed: 1200 rpm (drill); 270 rpm (ream)
Mode of Operation:
Duty Cycle:
Rest Between Cycles:
Non-continuous Operation
1 minute on/4 minutes off, 3 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

6203-001-700 Rev-E EN
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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 6203-001-700 Rev-E
Specifications (continued)
Environmental Conditions: Operation Storage and Transportation
Temperature Limitation:
Humidity Limitation:
Atmospheric Pressure
Limitation:
Guidance and manufacturer’s declaration - electromagnetic emissions
The System 6 Single Trigger Rotary Handpiece (REF 6203-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 6 Single Trigger Rotary Handpiece (REF
6203-000-000) 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 Single Trigger Rotary Handpiece (REF
6203-000-000) 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 Single Trigger Rotary Handpiece (REF 6203-
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

6203-001-700 Rev-E EN
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Guidance and manufacturer’s declaration - electromagnetic immunity
The System 6 Single Trigger Rotary Handpiece (REF 6203-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 6 Single Trigger Rotary Handpiece (REF
6203-000-000) 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
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
N/A N/A
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.

14 www.stryker.com
EN 6203-001-700 Rev-E
Guidance and manufacturer’s declaration - electromagnetic immunity
The System 6 Single Trigger Rotary Handpiece (REF 6203-000-000) is intended for use in the electromagnetic
environment specified below. The customer or the user of the System 6 Single Trigger Rotary Handpiece (REF
6203-000-000) 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 Single
Trigger Rotary Handpiece (REF 6203-000-000), 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 Pis 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.
a
Field 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 Single Trigger Rotary Handpiece
(REF 6203-000-000) is used exceeds the applicable RF compliance level above, the System 6 Single Trigger Rotary Handpiece (REF 6203-000-000) 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 Single Trigger Rotary Handpiece (REF 6203-000-000).
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

6203-001-700 Rev-E EN
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Recommended separation distances between portable and mobile RF communications equipment and the
System 6 Single Trigger Rotary Handpiece (REF 6203-000-000)
The System 6 Single Trigger Rotary Handpiece (REF 6203-000-000) is intended for use in the electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the System 6 Single
Trigger Rotary Handpiece (REF 6203-000-000) can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the System 6
Single Trigger Rotary Handpiece (REF 6203-000-000) 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 din 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.

2015-03 6203-001-700 Rev-E www.stryker.com
ES/DE/FR/IT/NL 6203-001-710
JA/ZH/KO 6203-001-720
SV/DA/FI/PT/NO 6203-001-730
PL/EL/TR 6203-001-750
Stryker Instruments
4100 E. Milham
Kalamazoo, Michigan
(USA) 49001
1-269-323-7700
1-800-253-3210