Stryker 6206 Saw Recip 3D Active Trac Service Manual Serial Number 1614 and Above

2006/05 6206-001-700 Rev- www.stryker.com
Instructions For Use
REF 6206
System 6
Reciprocating Saw
US Patents: 5,747,953; 6,013,991 and other patents pending.
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Intended Use

The Stryker System 6 Battery Powered Heavy Duty Reciprocating Saw is a linear cutting device used for cutting bone and bone related tissue.
DESCRIPTION REF
Short Blade ..................................................... 277-96-250
Offset Reciprocating Blade ........................... 277-96-251
Double Sided Blade .......................................277-96-275
Double Sided Blade, Offset ........................... 277-96-276
Double Sided Blade, Offset ........................... 277-96-277
Double Sided Blade, Offset, Long................. 277-96-278
Double Sided Blade, Long ............................. 277-96-281
Long Blade ......................................................277-96-300
Heavy Duty Reciprocating Blade ................... 277-96-325
Offset Reciprocating Blade ........................... 277-96-326
Large Battery Pack ...................................................6215

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.
*Contact your Stryker sales representative for a com­plete list of additional accessories.
Accessory Information*
WARNINGS:
• 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.
• ALWAYS use Stryker reciprocating blades REF 277­96-xxx series only. Failure to comply may result in patient and/or health care staff injury.
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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 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.
• DO NOT apply excessive pressure, such as bending or prying, with a cutting accessory to prevent fractur­ing the accessory. 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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User/Patient Safety (cont’d)
WARNING: If you are using one of the
following blades, watch for blade whip when the handpiece is operated below the maxi­mum speed:
Double Sided Reciprocating Blade ­REF 277-96-275
47.5 x 6 x 0.77mm Offset Reciprocating Blade - REF 277-96-251
70 x 12.5 x 8mm Double Sided Reciprocat­ing Blade - REF 277-96-276
70 x 12.5 x 1mm Double Sided Reciprocat­ing Blade - REF 277-96-277
Long Heavy Duty Reciprocating Blade ­REF 277-96-325
Blade whip increases the chance of blade fracture and may result in patient and/or health care staff injury.
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Features

Symbol Definitions

Slide the run/safe control to the safe position to lock the trigger and prevent inadvertent operation of the handpiece; the handpiece cannot be operated.
Slide the run/safe control to either run position (two available) to allow the hand­piece to operate while the trigger is depressed.
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 - The trigger is pressure sensitive for variable speed operation.
Run/Safe Control - Based on its position, allows the handpiece to operate in the run or safe mode; safe mode prevents the inadvertent operation of the handpiece.
Blade - Several Stryker blades are available.
Blade Collar - The spring-loaded blade collar allows the insertion and release of the blade.
Accessory Interface - Connector provides power and communication for future accessories.
Battery Latch
Battery Pack
Trigger Switch
Blade
Blade Collar
Run/Safe Control
Accessory Interface
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Slide the run/safe control to the safe position.
Rotate the spring-loaded blade collar clockwise align­ing the slots. Insert the blade (see figure 1).
1.
2.
Figure 1 To Install Blade
Figure 2 To Install Battery Pack

Instructions

NOTE: The blade teeth may be directed in any of four
positions.
To Install Battery Pack
NOTES:
• This handpiece is designed to accept a Stryker Large Battery Pack REF 6215 only. This battery pack can be charged in the Stryker System 6 Battery Charger REF 6110-120 configured with the appropriate battery charger module.
• 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.
Release the blade collar. Ensure the blade collar springs back to its original position indicating the blade is properly seated.
Gently tug the blade back and forth to ensure it is secure.
3.
4.
To Install Cutting Accessory
WARNING: To prevent the inadvertent
running of the handpiece, ALWAYS place the run/safe control in the safe position before installing or removing any cutting accessory.
Test the operation of the handpiece by sliding the run/safe control to a run position and squeezing the trigger.
Slide the run/safe control to the safe position until you are ready to use the handpiece.
2.
3.
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To Operate Handpiece
Instructions (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.
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 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, damaged battery pack with a shortened life.
To Remove Battery Pack
Depress the battery latch and pull the battery pack out.
To Remove Cutting Accessory
Rotate the spring-loaded blade collar clockwise to realign the slots and remove the cutting accessory.
WARNING: ALWAYS place the run/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.
Slide the run/safe control to the either position to allow the handpiece to operate.
Squeeze the pressure sensitive trigger for variable speed operation.
Slide the run/safe control to the safe position when you are finished operating the handpiece.
1.
2.
3.
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Troubleshooting Guide*
PROBLEM CAUSE ACTION
Handpiece does not run or re­ciprocates 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.
Run/safe control is in the safe position.
Slide the run/safe control to the run position.
Drivetrain is malfunctioning. Return the handpiece for repair.
Motor runs but blade does not move.
Drivetrain is malfunctioning. Return the handpiece for repair.
Battery pack becomes unusually hot during use.
Circuitry is malfunctioning. Check the battery pack on the charger. Replace the bat-
tery pack if required. See the instructions supplied with the battery charger.
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 inside of blade collar. Clean the handpiece with a small brush. Actuate the
blade collar several times to obtain smooth operation.
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 operat-
ing room.
Relocate electrical equipment; increase spatial distance.
Plug operating room equipment into different operating room outlets.
*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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To Drain Water From Handpiece
To Clean Handpiece
Remove the battery pack and cutting accessory from the handpiece.
Using a brush with stiff, non-metallic bristles and hospital enzymatic cleaner, scrub the debris from the handpiece. Pay special attention to crevices and other hard to reach areas such as seams, joints, and details around the blade retainer, trigger, and con­nector areas.
Rinse all the external surfaces of the handpiece under running water. Hold the handpiece upright to prevent water from running into the battery pack contact area.
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 handpieces for any remaining debris; if any debris is present, repeat the cleaning and rinsing procedure using fresh hospital enzymatic cleaner.
Dry the handpiece with a lint-free towel.
After cleaning, sterilize as directed. See Sterilization Recommendations.
5.
6.
7.

Cleaning Recommendations

WARNINGS:
• Clean and sterilize handpieces and batteries before first and every use.
• Prior to cleaning and sterilization, remove all acces­sories from the handpieces.
• DO NOT use solvents, lubricants, or other chemicals unless otherwise specified.
CAUTIONS:
• DO NOT immerse a handpiece 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 components.
To Clean Battery Packs and Accessories
See the care instructions supplied with the battery packs, battery pack modules and battery charger.
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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
• 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
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.
To Sterilize Handpieces
NOTE: After sterilization, allow the equipment to cool
to room temperature to ensure a comfortable operating temperature.
To Sterilize Battery Packs
See the care instructions supplied with the battery packs.
WARNINGS:
• Clean and sterilize handpieces and batteries before first and every use.
• Prior to cleaning and sterilization, remove all acces­sories from the handpieces.
Sterilization Recommendations*
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Specifications*
Model: REF 6206 Reciprocating Saw
Size: 8.60 in. [218 mm] height (with large battery pack)
1.475 in. [37 mm] width
7 in. [178 mm] length
Weight: 3.25 lbs. [1.46 kg] (with large battery pack)
Speed: 13,000 CPM
Excursion: 0.152 in. [3.9mm]
Duty Cycle:
Intermittent Operation - 1 minute on / 4 minutes off 5 times with a 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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Guidance and manufacturer's declaration - electromagnetic emissions
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.
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)
6206-001-700 Rev- 2006/05
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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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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)
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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 controlled.
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 recommend-
ed 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)
2006/05 6206-001-700 Rev- 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
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