Stryker System 5 User manual

1
IMPORTANT INFORMATION: File in your records
INSTRUCTIONS FOR USE REF 4208
Sagittal Saw
10/05 4208-001-700 Rev-C
US Patents: 5,263,972;
5,747,953; 6,013,991
4100 E. Milham
Kalamazoo, Michigan
(USA) 49001
269-323-7700
1-800-253-3210
www.stryker.com
European Authorized Rep:
RA/QA Manager
Stryker France
ZAC Satolas Green Pusignan
Av. de Satolas Green
69881 MEYZIEU Cedex
France

2
Important Information
WARNING - CAUTION - NOTE
Please read this manual and follow its instructions
carefully. The words WARNING, CAUTION and NOTE
carry special meanings and should be carefully
reviewed.
WARNING: The personal safety of the patient
and user may be involved.
Disregarding this information could
result in injury to the patient and/or
user.
CAUTION: These instructions point out special
service procedures or precautions
that must be followed to avoid
damaging the instrument.
NOTE: This provides special information to
make maintenance easier or
important instructions clearer.
An exclamation point within a
triangle displayed on the product is
intended to alert the user to the
presence of important operating
and maintenance instructions in this
manual.
Intended Use
The Stryker System 5 Battery Powered Heavy Duty Sag-
ittal Saw is an oscillating cutting device used for cutting
away bone and bone related tissue.
Accessories
DESCRIPTION REF
Battery Pack ............................. 4115, 4116, 4126
A list of cutting accessories is available from your
Stryker Instruments sales representative.

3
User/Patient Safety*
WARNINGS:
• Read and understand the information in this manual.
Familiarization with the Stryker System 5 Battery
Powered Instruments prior to use is important.
• Prior to each use, operate system components
and inspect for damage. DO NOT use if damage
is apparent. Take special precaution regarding
electromagnetic compatibility (EMC) when using
medical electrical equipment like the System 5
handpiece. Install and place the handpiece into
service according to the EMC information in this
manual. Portable and mobile RF communications
equipment, such as wireless phones, can affect the
function of the handpiece.
• Use only Stryker approved accessories. Other
accessories may result in increased emissions or
decreased immunity of the system. Contact your
Stryker sales representative for a complete list of
accessories. DO NOT modify any accessory. Failure
to comply may result in patient and/or operating room
staff injury.
• Prior to each use, system components should be
operated and inspected for any loose components
or damage. DO NOT use if these conditions exist.
Loose components could fall off the handpiece into
the wound site causing potential patient injury.
• Clean and sterilize instruments before first and every
use.
• This equipment is not suitable for use in the pres-
ence of flammable anesthetic mixture with air or with
oxygen or nitrous oxide.
• Avoid unintentional operation of the handpiece. A
handpiece that contains a battery should always be
placed in the SAFE mode while it is either sitting
idle or an accessory is being attached or removed.
Remove the battery pack from the handpiece when
the instrument is not in use.
• DO NOT pry or use excessive force on the blade as
the blade may bend and/or break causing potential
patient injury.
• Use only Stryker approved accessories. Only Stryker
saw blades can be used with the Sagittal Saw. A list
of accessories is available from your Stryker Instru-
ments sales representative.
• DO NOT service handpieces or battery packs. These
products contain no parts that the user can service.
• Reuse of single use blades can cause blade break-
age and possible injury to the patient and/or user.
CAUTIONS:
• DO NOT stall the handpiece to prevent damaging the
electric motor and/or battery pack. If the handpiece
jams, release the trigger immediately. Remove any
obstructions before continuing the procedure.
• DO NOT immerse the handpiece or battery pack. Wa-
ter may enter the casing and damage the electrical
components.
*For further information, contact your Stryker Instruments sales representative or Customer Service at 1-800-
253-3210. Outside the USA, contact your nearest Stryker subsidiary.

4
Features and Functions
•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.
•Blade Lock Button - The button allows the insertion and release of the blade.
•Blade Retainer- The retainer holds the blade.
•Sagittal Head - The sagittal head may be indexed in 45° increments and can turn in a complete 360° rotation to
achieve the desired cutting angle.
•Trigger Switch - The trigger is pressure sensitive for variable speed operation. When rotated, the trigger switch
allows the cutting tool to operate in STD (standard), SAFE and FAST mode.
Battery Pack
Sagittal Head
Blade Retainer
Symbol Definitions
Blade Lock Button
Trigger Switch
Battery Latch
The SAFE position locks
the trigger and prevents
inadvertent operation
of the handpiece; the
handpiece cannot be
operated.
The FAST position
allows the handpiece
to operate at high
torque and high speed
when the trigger is
depressed.
The STD (standard)
position allows the
handpiece to operate
at high torque and
standard speed
when the trigger is
depressed.

5
Blade Installation
WARNING:
Always place the trigger switch in the SAFE position
before attaching or removing any accessory to prevent
inadvertent running of the handpiece.
1. Rotate the trigger switch clockwise to the SAFE
position.
2. Depress the blade lock button and insert the blade
until the FULL INSERT line disappears in the blade
retainer indicating the blade is positioned properly
(see figure 1).
3. Release the blade lock button. Gently tug the blade to
ensure it is secure.
Figure 1 Blade Insertion
Instructions
1. Pull the sagittal head forward and away from the
handpiece body; then rotate it to the desired cutting
angle (see figure 2).
NOTE: The sagittal head has eight possible cutting
angle positions (45° increments).
CAUTION:
Before use, the sagittal head must be firmly locked
against the handpiece body to prevent damage to the
instrument. Ensure NO gap exists between the sagittal
head and the handpiece body.
2. Once positioned, gently turn the sagittal head to
ensure that it has snapped into place against the
handpiece body and is locked into position (see
figure 2).
Figure 2 Sagittal Head Positioning
Sagittal Head Positioning
No Gap

6
Instructions (cont’d)
Battery Pack Installation
NOTES:
• The Sagittal Saw is designed to accept REF 4115,
REF 4116, or REF 4126 batteries. These batteries
may be charged in the System 4 or 5 Battery Charger
configured with Charger Module REF 4110-415, REF
4110-416, or REF 4110-426 respectively. The REF
4115 battery may also be charged in the System
2000 Charger with Battery Adaptor (REF 4110-115).
• Refer to the instructions supplied with the battery
charger and/or battery 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 3).
Figure 3 Battery Pack Installation
2. Test the operation of the handpiece by rotating the
trigger switch to either the STD or FAST position and
squeezing the trigger.
3. Set the trigger switch to the SAFE position until you
are ready to use the handpiece.
Saw Operation
NOTE: The handpiece has a variable speed motor that
is controlled by slight pressure variations on the trigger.
CAUTION:
When operating the saw, let the blade do the cutting.
Applying too much pressure will bend the blade and
reduce the cutting quality.
Battery Pack Removal
Depress the battery latch and pull the battery pack out.
Blade Removal
Depress the blade lock button and remove the blade.
Battery Latch

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PROBLEM
Instrument does not run or oscillates at a
reduced speed making cutting difficult.
Motor runs but blade does not move.
Battery pack becomes unusually hot
during use.
Blade will not fit into the blade retainer or
cannot be secured.
Handpiece has become noisy and vibrates.
Sporadic electrical interference is expe-
rienced.
Troubleshooting Guidelines*
*This product is not field repairable. In case of operating difficulties, all Stryker products must be returned to Stryker Instruments for repair.
For more information, contact your Stryker Instruments sales representative or call Stryker Customer Service at 1-800-253-3210. Outside the
USA, contact your nearest Stryker subsidiary.
CAUSE
Battery pack is discharged.
Battery pack is expended.
Trigger switch is in the SAFE position.
Drivetrain is malfunctioning.
Drivetrain is malfunctioning.
Circuitry is malfunctioning.
Debris is inside the end of the blade
retainer.
Blade is not a Stryker product.
Blade retainer is damaged.
Blade is not a Stryker product.
Drivetrain is malfunctioning.
Electrical noise is present.
ACTION
Recharge the battery in Stryker charger.
Replace the battery pack.
Set the trigger switch to the FAST or STD
position.
Return the handpiece for repair.
Return the handpiece for repair.
Check the battery pack on the Stryker
charger and replace it if indicated. See
Charger Instructions.
Clean with a small brush.
Use a Stryker blade.
Return the handpiece for repair.
Use a Stryker blade.
Return the handpiece for repair.
Turn off all electrical equipment not in use
in the operating room.
Relocate electrical equipment; increase
spatial distance.
Plug operating room equipment into differ-
ent operating room outlets.

8
Periodic Maintenance
INTERVAL ACTIVITY
Prior to each use. Inspect, operate and test the handpiece to ensure that it is
working properly. Ensure 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.
Storage and Handling
To ensure the longevity, performance and safety of this equipment, package in original packaging materials when
storing or transporting.

9
Cleaning Recommendations
WARNINGS:
• Handpieces and batteries must be cleaned and steril-
ized before first and every use.
• DO NOT use solvents, lubricants, or other chemicals
unless otherwise specified.
CAUTION:
DO NOT immerse the handpiece or battery pack.
Battery Packs and Accessories
Refer to the Cleaning Recommendations for the battery
packs, battery pack adaptors and chargers provided
with those products.
Handpiece
1. Remove the battery pack and blade from the
handpiece.
2. Using a stiff bristle brush and mild detergent (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 and trigger areas.
CAUTION:
DO NOT allow water to run directly into the battery
contact area.
3. Rinse instruments under running water. Hold the
handpiece upright to prevent water from running into
the battery contact area.
4. If water leaks into the handpiece, tip the handpiece
back as shown below to allow drainage from a small
opening in the battery contact area.
5. Visually inspect the handpiece for any remaining de-
bris; if any is present, repeat the cleaning and rinsing
procedure using fresh hospital enzymatic cleaner.
6. Dry the handpiece with a lint-free towel.
7. After cleaning, sterilize as directed. See Sterilization
Recommendations.
Drain Water From Handpiece

10
Sterilization Recommendations
WARNINGS:
• Handpieces and batteries must be cleaned and
sterilized before first and every use.
• Remove the blade and battery from the handpiece
prior to sterilization.
To obtain optimum performance from the instruments
and help prevent damage to the instruments, it
is essential that one of the following sterilization
procedures be performed.
“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
Battery Packs
Refer to the Sterilization Recommendations provided
with the battery packs.
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
Sterilization Recommendations
Validation based on AAMI protocol.
Handpiece

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Model: REF 4208 Sagittal Saw
Size: 8.9 in. [226 mm] height (with battery)
1.6 in. [41 mm] width
6.5 in. [165 mm] length
Weight: 3.4 lbs. [1.54 kg] (with battery)
Speed: 10,000 CPM (STD mode); 12,000 CPM (FAST mode)
Excursion: 5° arc
Duty Cycle: Intermittent Operation - 1 minute on / 4 minutes off 5 times
with a 3 hour rest
Approvals: 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
Enclosure Protection: IPX0 Ordinary Equipment
Environmental Conditions: Operation Storage and Transportation
Temperature:
Relative Humidity:
Atmospheric Pressure:
*Specifications listed are approximate and may vary slightly from unit to unit or by power supply fluctuations.
Specifications*

12
Guidance and manufacturer’s declaration - electromagnetic emissions
The System 5 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of
the System 5 handpiece should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Compliance
Group 1
Class B
n/a
n/a
Electromagnetic environment - guidance
The System 5 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.

13
Guidance and manufacturer’s declaration - electromagnetic immunity
The System 5 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of
the System 5 handpiece should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
test level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance level
n/a
n/a
3 V/m
80 MHz to 2.5 GHz
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the System 5 handpiece, including cables, than
the recommended separation 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 dis the
recommended separation distance in meters (m)
Interference may occur in the vicinity of equipment
marked with the following symbol:
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.

14
Guidance and manufacturer’s declaration - electromagnetic immunity
The System 5 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the System 5
handpiece should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
±6 kV contact
±8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
±1 kV differential mode
±2 kV common mode
<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
3 A/m
Compliance level
±2, 4, 6 kV contact
±2, 4, 8 kV air
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
3 A/m
NOTE: UTis the a.c. mains voltage prior to application of the test level.
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30%.
Power frequency magnetic fields should be at levels
characteristics of a typical location in a typical commercial
or hospital environment.

15
Recommended separation distances between portable and mobile RF communications equipment and the System 5
handpiece
The System 5 handpiece is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the System 5 handpiece can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the System 5 handpiece as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
W
0.01
0.1
1
10
100
150 kHz to 80 MHz
d= [ —]√P
n/a
n/a
n/a
n/a
n/a
80 MHz to 800 MHz
d= [ —]√P
0.12
0.37
1.17
3.70
11.70
800 MHz to 2.5 GHz
d= [ —]√P
0.23
0.74
2.33
7.37
23.30
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 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.
Separation distance according to frequency of transmitter
m
3.5
V1
3.5
E1
7
E1

16
Repair and Loaner Program
This service is available in the United States only. Outside the USA, contact your Stryker sales representative or nearest Stryker
subsidiary.
On request, Stryker Instruments will provide a loaner unit for your use while repairs are being made. Please clean and sterilize all
potentially contaminated products being sent in for repair, credit, or return of a loaner unit. The policy of Stryker Instruments is not to
accept or process potentially contaminated products that do not meet this requirement.
Also, please be aware that it is unlawful to transport bio-contaminated products through interstate commerce that are not properly
packaged and labeled as such.
1. Contact Stryker Customer Service at 1-800-253-3210 to request a loaner. Provide a name and address for shipping. Every effort
will be made to send a loaner unit immediately.
2. Send the inoperative unit to Stryker with a purchase order number of authorization for repair. The order should explain the nature
of the difficulty. Also, provide a name and address for shipping the repaired instruments.
Return the inoperative unit to: Stryker Instruments
Repair Department
4100 E. Milham
Kalamazoo, Michigan, 49001
3. The repaired unit will be shipped back and the repair invoice will follow under separate cover. Under most conditions, repair
turnaround time will be approximately 2 to 3 weeks.
4. As soon as your repaired unit is returned, return the loaner to Stryker Instruments.
Limited Warranty
In the U.S.A. only, products of Stryker Instruments are warranted to the original purchaser for a period of one year from the date
of purchase, with exceptions noted below. Products are warranted to be free from defects in material and workmanship. Abnormal
wear and tear or damage caused by misuse or by failure to perform normal and routine maintenance as set out in these instructions,
or as demonstrated by an authorized Stryker Instruments representative, is not covered by the warranty. Any effort at field repair or
adjustment may invalidate your warranty.
The warranty extends to all purchasers and is limited to the repair or replacement of the product without charge when returned
prepaid to Stryker Instruments. There are no other expressed warranties. This warranty gives you specific legal rights and you may
have other rights which vary by state and municipality.
For selected products: Battery Packs are warranted for a period of 90 days from the date of invoice.
European Equiv. 4208-001-713
N. European Equiv. 4208-001-730
Japanese Equiv. 4208-001-720
Polish Equiv. 4208-001-750