2008/01 6205-001-700 Rev-A www.stryker.com
Instructions For Use
REF 6205
System 6
Dual Trigger Rotary Handpiece
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2008/01 6205-001-700 Rev-A
Intended Use
The Stryker System 6 Battery Powered Heavy Duty Dual
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.
Accessory Information*
DESCRIPTION REF
Small Battery Pack ................................................... 6212
Large Battery Pack .................................................. 6215
Aseptic Battery Kit ..................................................... 6126
Small Aseptic Battery Kit .......................................... 6127
*See the System 6 Rotary Handpiece Attachments
booklet for a complete list of attachments. Contact your
Stryker sales representative for a complete list of additional accessories.
WARNING: Use only Stryker-approved
components and accessories, unless otherwise specified. Other accessories may result in increased electromagnetic emissions
or decreased electromagnetic immunity of
the system. DO NOT modify any component
or accessory. Failure to comply may result
in patient and/or health care staff injury.
Important Information
The words WARNING, CAUTION and NOTE have special
meaning and should be reviewed.
WARNING:
Disregarding WARNING information
may compromise the safety of the
patient and/or health care staff and
may result in injury.
CAUTION:
Disregarding CAUTION information
may compromise product reliability
and may result in damage.
NOTE:
NOTE information supplements and/
or clarifies procedural information.
A triangle with an exclamation point
alerts the health care professional to
read and understand the accompanying instructions, especially the
operating, maintenance, and safety
information.
6205-001-700 Rev-A 2008/01
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User/Patient Safety*
WARNINGS:
• Only trained and experienced health care 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 system components prior
to use. Failure to comply may result in patient and/or
health care staff injury.
• 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.
Failure to comply may result in patient and/or health
care staff injury.
• Perform recommended periodic maintenance as
indicated in the instructions for use. Only trained
and experienced health care professionals should
maintain this equipment.
• Clean and sterilize handpieces, attachments and batteries before first and every use.
• DO NOT use this equipment in the presence of a
mixture consisting of flammable anesthetic and air or
with 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.
• ALWAYS place the handpiece in the safe mode while
the handpiece is idle, before installing or removing
any accessory, or when passing the handpiece to another person. Failure to comply may result in patient
and/or health care staff injury.
• A wobbling attachment may cause bone or tissue
damage or inaccurate wiring or pin placement. If
wobbling occurs, see Troubleshooting Guide. Failure
to comply may result in patient injury.
• 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.
Failure to comply may result in patient and/or health
care staff injury.
• DO NOT reuse single use cutting accessories. Failure
to comply may result in patient and/or health care
staff injury.
*If you need more information, contact your Stryker sales representative or call Stryker customer service at 1-800-253-3210. Outside
the US, contact your nearest Stryker subsidiary.
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2008/01 6205-001-700 Rev-A
Features
• Battery Latch - To release the battery pack from the handpiece, depress the battery latch.
• Battery Pack - Rechargeable battery pack provides power to the handpiece.
• Reverse Trigger - To cause counterclockwise rotation and vary speed, press this pressure-sensitive trigger.
• Forward Trigger - To cause clockwise rotation and vary speed, press this pressure-sensitive trigger.
• F/R/Safe Control - Based on its position, allows the handpiece to operate in forward, reverse, or oscillate mode;
safe mode prevents the 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.
Symbol Definitions
FORWARD - Fully depress the
F/R/Safe control to lock the
reverse trigger. The forward trigger
is functional.
REVERSE - Press trigger to
operate in the counterclockwise direction.
REAM - For slow
speed, rotate the
shifter knob to REAM.
SAFETY - Center the F/R/Safe
control to lock both triggers.
OSCILLATE - Press both
triggers to operate the handpiece in the oscillate mode.
DRILL - For fast
speed, rotate the
shifter knob to DRILL.
FORWARD/REVERSE - Fully
extend the F/R/Safe control to
unlock both triggers. Both triggers
are functional.
FORWARD - Press trigger
to operate in the clockwise
direction.
Battery Latch
Battery Pack
Forward Trigger
Actuating Collar
Shifter Knob
F/R/Safe Control
Reverse Trigger
Accessory Interface
6205-001-700 Rev-A 2008/01
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Figure 2 To Install Battery Pack
Instructions
To Install Battery Pack
NOTES:
• This handpiece is designed to accept a Stryker Large
or Small Battery Pack only (REF 6215 or REF 6212).
These battery packs can be charged in the Stryker
System 6 Battery Charger REF 6110-120 configured
with the appropriate battery charger modules.
• See the instructions supplied with the battery charger
and/or battery pack for charging details and specifications.
Slide a fully charged battery pack firmly into the
handpiece until the battery latch snaps, indicating the
battery pack is secure (see figure 2).
1.
Test the operation of the handpiece by sliding the
F/R/Safe control to FORWARD (F) or FORWARD/REVERSE (F/R) and squeezing the trigger.
Slide the F/R/Safe control to the safe position until
you are ready to use the handpiece.
2.
3.
Slide the F/R/Safe control to the safe position.
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).
1.
2.
Once properly aligned, insert the attachment into the
handpiece until the attachment “snaps” into place.
Tug the attachment to ensure it is secure.
Install the desired cutting accessory. See the System
6 Rotary Handpiece Attachments booklet.
3.
4.
5.
NOTE: Several attachments are available and each
has a specialized accessory retainer.
WARNING: To prevent inadvertent run-
ning of the handpiece, ALWAYS place the
F/R/Safe control in the safe position before
installing or removing any attachment.
To Install Attachment
Figure 1 To Install Attachment
Driveshaft
Tabs
Notches
(not always
present)
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2008/01 6205-001-700 Rev-A
Instructions (cont’d)
To Remove Attachment
Slide the F/R/Safe control to the safe position.
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.
1.
2.
To Change Handpiece Speed
WARNINGS:
• DO NOT change the handpiece speed while operating the handpiece. Failure to comply may result in
patient and/or health care staff injury.
• 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 health
care staff injury.
To Operate Handpiece
Slide the F/R/Safe control to the appropriate position
to allow the handpiece to operate in the forward,
reverse or oscillate mode.
Squeeze the appropriate pressure sensitive trigger
for variable speed operation. For oscillation, squeeze
both triggers simultaneously.
Slide the F/R/Safe control to the safe position when
you are finished operating the handpiece.
1.
2.
3.
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.
• For DRILL mode, rotate the shifter knob counter
-
clockwise until it clicks in place.
• For REAM mode, rotate the shifter knob clockwise
until it clicks in place.
Ensure the handpiece is not running.
Change the handpiece speed as follows:
1.
2.
Test the operation of the handpiece.
Slide the F/R/Safe control to the safe position until
you are ready to use the handpiece.
3.
4.
WARNING: ALWAYS place the F/R/Safe
control in the safe position while the
handpiece is idle, before installing or
removing an accessory, or when passing
the handpiece to another person. Failure to
comply may result in patient and/or health
care staff injury.
6205-001-700 Rev-A 2008/01
www.stryker.com 7
Troubleshooting Guide*
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 position. Slide F/R/Safe control to the forward or
forward/reverse position.
Drivetrain is malfunctioning. Return the handpiece for repair.
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 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 reamers in the REAM mode.
*DO NOT service this equipment. If you require service, contact your Stryker sales representative or call Stryker customer service
at 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary.
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2008/01 6205-001-700 Rev-A
Troubleshooting Guide (cont’d)
Periodic Maintenance
Storage and Handling
To ensure the longevity, performance and safety of this equipment, use the original packaging materials when storing or transporting this equipment.
INTERVAL ACTIVITY
Prior to each use. Inspect, operate and test the handpiece to ensure that it is working properly. Ensure that there are no
loose or missing components. Check all moving parts for free movement. Be alert for unusual sounds or
vibrations and note the operating speed.
PROBLEM CAUSE ACTION
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.
6205-001-700 Rev-A 2008/01
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Cleaning Recommendations
WARNINGS:
• Clean and sterilize handpieces, attachments and batteries before first and every use.
• Prior to cleaning and sterilization, remove all attachments and accessories from the handpieces.
• DO NOT use solvents, lubricants, or other chemicals
unless otherwise specified.
CAUTIONS:
• DO NOT immerse a handpiece, attachment or battery
pack in liquid. Moisture may enter the equipment,
cause corrosion, and damage the electrical and/or
mechanical components.
• DO NOT allow liquid to run directly into any electrical
connection. Moisture may cause corrosion to electrical and/or mechanical components.
To Drain Water From Handpiece
To Clean Battery Packs and Accessories
See the care instructions supplied with the battery
packs, battery pack modules and battery charger.
To Clean Handpiece and Attachments
Remove the battery pack and attachment from the
handpiece.
Using a brush with stiff, non-metallic bristles and
hospital enzymatic cleaner, scrub the debris from the
handpiece and attachments. Pay special attention
to crevices and other hard to reach areas such as
seams, joints, and details around the retainer, trigger,
and connector areas. Use a bottle brush to clean the
cannula.
Rinse all external surfaces of the handpiece under
tap water. Hold the handpiece upright to prevent water from running into the battery contact area. Flush
the cannula with running water.
If water leaks into the handpiece, tip the handpiece
back as shown below to allow drainage from a small
opening in the battery pack contact area.
1.
2.
3.
4.
Visually inspect the handpiece for any remaining
debris; if any debris is present, repeat the cleaning
and rinsing procedure using fresh hospital enzymatic
cleaner.
Dry the handpiece and attachments with a lint-free
towel.
After cleaning, sterilize as directed. See Sterilization
Recommendations.
5.
6.
7.
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2008/01 6205-001-700 Rev-A
WARNINGS:
• Clean and sterilize handpieces, attachments and batteries before first and every use.
• Prior to cleaning and sterilization, remove attachments and all accessories from the handpieces.
• Orient the handpiece to allow steam to flow through
the cannulated handpiece when using a gravity displacement sterilizer.
To obtain optimal performance and prevent damage,
perform one of the following sterilization procedures:
“Flash” Autoclave:
• Gravity displacement sterilizer
• 270-272 °F (132-134 °C)
• Unwrapped in an instrument tray in a vertical position
so steam can flow through the cannula
• 10-minute minimum exposure time
Hi Vac:
• Pre-vacuumed sterilizer
• 270-272 °F (132-134 °C)
• Wrapped or unwrapped
• 4-minute minimum exposure time
• 8-minute minimum dry time
To Sterilize Battery Packs
See the care instructions supplied with the battery
packs.
To Sterilize Handpieces and Attachments
Sterilization Recommendations*
ETO:
• 100% ETO
• 120-135 °F (49-57 °C)
• Wrapped in an instrument tray or fully perforated
sterilization box
• 2-hour 30-minute exposure time, 8-hour minimum
aeration time
250 °F Gravity:
• Gravity displacement sterilizer
• 250-254 °F (121-123 °C)
• Wrapped in an instrument tray or fully perforated
sterilization box
• 50-minute exposure time
• 8-minute minimum drying time
270 °F Gravity:
• Gravity displacement sterilizer
• 270-272 °F (132-134 °C)
• Wrapped in an instrument tray or fully perforated
sterilization box
• 35-minute minimum exposure time
• 8-minute minimum dry time
*Validation is based on the Association for the Advancement of
Medical Instrumentation (AAMI) protocol.
NOTE: After sterilization, allow the equipment to cool
to room temperature to ensure a comfortable operating
temperature.
6205-001-700 Rev-A 2008/01
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Specifications*
Model: REF 6205 Dual Trigger Rotary Handpiece
Size: 8.6 in. [219 mm] height (with large battery pack)
1.5 in. [38 mm] width
6.0 in. [153 mm] length
Weight: 3.5 lbs. [1.6 kg] (with large battery pack)
Speed: 1200 rpm (drill); 270 rpm (ream)
Duty Cycle:
Intermittent Operation - 1 minute on/4 minutes off 3 times with 3 hour rest
Approval: CSA International
CAN/CSA-C22.2 No. 601.1-M90
UL 60601-1
IEC 60601-1
Equipment Type:
Type BF Applied Part
Power Supply: Internally Powered 9.6 V
Enclosure Protection: IPX0 Ordinary Equipment
Environmental Conditions: Operation Storage and Transportation
Temperature:
Relative Humidity:
Atmospheric Pressure:
*Specifications are approximate and may vary from unit to unit or as a result of power supply fluctuations.
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2008/01 6205-001-700 Rev-A
Guidance and manufacturer's declaration - electromagnetic emissions
The System 6 handpdiece is intended for use in the electromagnetic environment specified below. The customer or the user of
the System 6 handpiece 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 handpiece 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
CISPR 11
Class B The System 6 handpiece is suitable for use in all establishments, includ-
ing domestic establishments 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 (cont’d)
6205-001-700 Rev-A 2008/01
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Guidance and manufacturer's declaration - electromagnetic immunity
The System 6 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the
System 6 handpiece 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
3 Vrms
150 kHz to 80 MHz
n/a
n/a
Portable and mobile RF communications equipment
should be used no closer to any part of the System 6
handpiece, including cables, than the recommended sep-
aration distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d=1.67√P
d=1.67√P
80 MHz to 800 MHz
d=2.33√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 d is the recommended separation
distance in meters (m)
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
80 MHz to 2.5 GHz
NOTE 1: At 80 MHz and 800MHz 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.
Specifications (cont’d)
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2008/01 6205-001-700 Rev-A
Guidance and manufacturer's declaration - electromagnetic immunity
The System 6 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the
System 6 handpiece 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
±2, 4, 6 kV contact
±2, 4, 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 differential mode
±2 kV common mode
n/a
n/a
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in UT )
for 0,5 cycle
n/a
40%
U
T
(60% dip in UT)
for 5 cycles
n/a
70% UT
(30% dip in UT)
for 25 cycles
n/a
<5% U
T
(>95% dip in UT )
for 5 sec
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 characteristics of a
typical location in a typical commercial
or hospital environment.
NOTE:
UT is the alternating current mains voltage prior to application of the test level.
Specifications (cont’d)
6205-001-700 Rev-A 2008/01
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Recommended separation distances between portable and mobile RF communications
equipment and the System 6 handpiece
The System 6 handpiece is intended for use in the electromagnetic environment in which radiated RF disturbances are con-
trolled. The customer or the user of the System 6 handpiece can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the System 6 handpiece 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 800 MHz to 2.5 GHz
0.01 n/a 0.12 0.23
0.1 n/a 0.37 0.74
1 n/a 1.17 2.33
10 n/a 3.70 7.37
100 n/a 11.70 23.30
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 P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800MHz, 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.
Specifications (cont’d)
2008/01 6205-001-700 Rev-A www.stryker.com
Stryker Instruments
4100 E. Milham
Kalamazoo, Michigan
(USA) 49001
1-269-323-7700
1-800-253-3210
Stryker France
ZAC Satolas Green Pusignan
Av. de Satolas Green
69881 MEYZIEU Cedex
France
ES/DE/FR/IT/NL
JA/ZH/KO
SV/DA/FI/PT/NO
PL/EL
6205-001-710
6205-001-720
6205-001-730
6205-001-750
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