Stryker System 5 4207 User manual

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IMPORTANT INFORMATION: File in your records
INSTRUCTIONS FOR USE REF 4207
Recip/Sternum Saw
10/05 4207-001-703 Rev-C
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
US Patents: 5,747,953;
6,001,115; 6,013,991

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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
Recip/Sternum Saw is a linear cutting device used for
cutting away bone and bone related tissue including the
sternum.
Accessories
DESCRIPTION REF
Battery Pack ....... 4112, 4212, 4215, 4222, 4226
Sternum Blade Guard............................. 4107-8
A list of cutting accessories is available from your
Stryker Instruments sales representative.

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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 presence 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 Recip/Sternum Saw. A list
of accessories is available from your Stryker Instruments
sales representative.
• DO NOT service handpieces or battery packs. These
products contain no parts that the user can service.
• If you are using a Stryker Reciprocating Double Sided
Blade (REF 277-96-275) or a Reciprocating Heavy Duty
Blade (REF 277-96-325), be alert to blade whip when
the handpiece is operated below the maximum speed.
Blade whip increases the chance of blade fracture and
user/patient injury.
• DO NOT operate the handpiece until the blade is in
contact with bone or tissue. Operating the handpiece
before the blade is in contact with bone or tissue may
cause the blade to break or eject from the handpiece
and endanger persons nearby.
• Reuse of single use blades can cause blade breakage
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. Water
may enter the casing and damage the electrical compo-
nents.
*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.

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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.
•Safety Switch - The switch allows the cutting tool to operate in RUN or SAFE mode. The switch prevents
inadvertent operation of the handpiece.
•Blade Collar - The spring-loaded blade collar allows the insertion and release of the blade.
•Blade - The blade teeth may be directed in any of four positions.
•Sternum Blade Guard - Protects soft tissue from coming into contact with the blade.
•Guard Actuating Button - Depress button to release the sternum blade guard.
•Trigger - The trigger is pressure sensitive for variable speed operation.
Battery Pack
Trigger
Sternum Blade Guard
Blade Collar
Symbol Definitions
Guard Actuating Button
Safety Switch
Battery Latch
(other side)
Blade
Safety switch
shown in SAFE
position; the
handpiece can-
not be operated.
Safety switch
shown in the RUN
position; depress
trigger to operate
the handpiece.
RUN
SAFE
RUN
SAFE
SAFE RUN

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Blade Installation
WARNING:
Always place the safety switch in the SAFE position
before attaching or removing any accessory to prevent
inadvertent running of the handpiece.
1. Rotate the safety switch clockwise to the SAFE
position.
2. Rotate the spring-loaded blade collar clockwise
aligning the slots. Insert the blade (see figure 1).
NOTE: The blade teeth may be directed in any of four
positions. However, if using the sternum blade guard,
the teeth must point away from the sternum blade
guard.
3. Release the blade collar. Ensure the blade collar
springs back to its original position indicating the
blade is properly seated.
4. Gently tug the blade back and forth to ensure it is
secure.
Figure 1 Blade Insertion
Instructions
Sternum Blade Guard Installation
NOTE: When the sternum blade guard is used, it can
be installed in the orientation shown or rotated 180° (see
figure 2). The blade teeth must point away from the
sternum blade guard.
1. Slide the guard actuating button and position the
sternum blade guard over the blade so that the
blade’s teeth are pointing away from the guard.
Release the guard actuating button to secure the
sternum blade guard.
2. Gently tug the sternum blade guard to ensure it is
secure.
3. Visually inspect the blade and sternum blade guard
to ensure the blade neither retracts nor extends from
the sternum blade guard.
Figure 2 Guard Installation

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Instructions (cont’d)
WARNINGS:
• If the blade retracts or extends from the end of the
sternum blade guard, the blade may cause tissue
damage.
• Do not grasp the handpiece near the guard actuating
button or handle the handpiece in a way that may
displace the guard actuating button during use.
Displacing the guard actuating button causes the
sternum blade guard to disengage and may cause
loss of tactile control and patient injury.
Battery Pack Installation
NOTES:
• The Recip/Sternum Saw is designed to accept REF
4112, REF 4212, REF 4215, REF 4222 or REF 4226
batteries (or kit). These batteries may be charged
in the System 4 Battery Charger configured with
Charger Module REF 4110-412, REF 4110-422, or
REF 4110-426 respectively. The REF 4112 battery
may also be charged in the System 2000 Charger
with Battery Adaptor (REF 4110-112).
• 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 setting the
safety switch to the RUN position and squeezing the
trigger.
3. Set the safety 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 Latch

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Battery Pack Removal
Depress the battery latch and pull the battery pack out.
Sternum Guard Removal
Rotate the guard actuating button to disengage the
sternum blade guard and withdraw it from the hand-
piece.
Blade Removal
Rotate the spring-loaded blade collar clockwise to
realign the slots and remove the blade.
Instructions (cont’d)

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PROBLEM
Instrument does not run or reciprocates 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 collar.
Blade collar does not spring back to retain
the blade.
Sternum blade guard will not fit into the
handpiece.
Handpiece has become noisy and vibrates.
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.
Safety switch is in the SAFE position.
Drivetrain is malfunctioning.
Drivetrain is malfunctioning.
Circuitry is malfunctioning.
Debris is inside the end of the blade
collar.
Blade collar is damaged.
Debris is inside of blade collar.
Debris is inside of the blade guard
retainer.
Sternum blade guard is damaged.
Drivetrain is malfunctioning.
ACTION
Recharge the battery in Stryker charger.
Replace the battery pack.
Set the safety switch to the RUN position.
Return the handpiece for repair.
Return the handpiece for repair.
Check the battery pack on the Stryker
charger and replace if indicated. See
Charger Instructions.
Clean with a small brush.
Return the handpiece for repair.
Clean with small brush, then actuate blade
collar several times to obtain smooth
operation.
Clean with a small brush.
Replace the sternum blade guard.
Return the handpiece for repair.

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Troubleshooting Guidelines (cont’d)
PROBLEM
Sporadic electrical interference is expe-
rienced.
CAUSE
Electrical noise is present.
ACTION
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.
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.

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Cleaning Recommendations
WARNINGS:
• Handpieces, accessories and batteries must be
cleaned and sterilized 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 and Sternum Blade Guard
1. Remove the battery pack, sternum blade guard and
blade from the handpiece.
2. Using a stiff bristle brush and mild detergent (hospital
enzymatic cleaner), scrub the debris from the
handpiece and sternum blade guard. Pay special
attention to crevices and other hard to reach areas
such as seams, joints, and details around the blade
collar and trigger areas. Rotate the safety switch
and guard actuating button to clean around and
under them.
CAUTION:
DO NOT allow water to run directly into the battery
chamber. Minimize the amount of water running into the
guard slot.
3. Rinse all external surfaces of the handpiece and
sternum blade guard under running water.
4. Actuate the guard actuating button to flush water
from the small holes in the handpiece.
5. Visually inspect the handpiece for any remaining
debris; if any is present, repeat the cleaning and
rinsing procedure using fresh hospital enzymatic
cleaner.
6. Dry the handpiece and sternum blade guard with a
lint-free towel.
7. After cleaning, sterilize as directed. See Sterilization
Recommendations.

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Sterilization Recommendations
WARNINGS:
• Handpieces and batteries must be cleaned and
sterilized before first and every use.
• Remove the sternum blade guard, 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 and Sternum Blade Guard

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Model: REF 4207 Recip/Sternum Saw
Size: 7.4 in. [188mm] height (with battery)
1.5 in. [38.1mm] width
7 in. [178mm] length (without sternum blade guard)
Weight: 2.5 lbs. [1.13kg] (with battery, but without sternum blade guard)
Speed: 11,000 CPM
Excursion: 0.152 in. [3.9mm]
Duty Cycle: Intermittent Operation - 1 minute on / 4 minutes off 5 times
with a 3 hour rest
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*

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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.

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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.

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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.

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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

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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.

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