Stryker System 5 4207 Instructions For Use Manual Download Page 2

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IMPORTANT INFORMATION

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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

Summary of Contents for System 5 4207

Page 1: ......

Page 2: ...num 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 ...

Page 3: ...ging 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 devi...

Page 4: ...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 accessorie...

Page 5: ...lade 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 Swit...

Page 6: ...dicating 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 st...

Page 7: ... 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 Pac...

Page 8: ...tery 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 ...

Page 9: ...bsidiary 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 AC...

Page 10: ... 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...

Page 11: ...ternum 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 t...

Page 12: ...wrapped 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 instrume...

Page 13: ...n 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...

Page 14: ...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 interfer...

Page 15: ... 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 d is ...

Page 16: ...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 UT is the a c mains voltage prior to a...

Page 17: ...er 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 d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rat...

Page 18: ...r 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 ...

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Page 21: ...1 731 Japanese Equiv 4207 001 720 Polish Equiv 4207 001 750 4100 E Milham Kalamazoo Michigan USA 49001 269 323 7700 1 800 253 3210 European Authorized Rep RA QA Manager Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France ...

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