2007/09
6208-001-701 Rev-B
www.stryker.com
Instructions For Use
System 6
Sagittal Saw
Ref 6208
US Patents: 5,263,972; 5,747,953; 6,013,991
Страница 1: ...2007 09 6208 001 701 Rev B www stryker com Instructions For Use System 6 Sagittal Saw ref 6208 US Patents 5 263 972 5 747 953 6 013 991 ...
Страница 2: ...y Failure to comply may result in patient and or health care staff injury ALWAYS use Stryker sagittal saw blades with this handpiece 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 healt...
Страница 3: ... 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 electri cal 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 t...
Страница 4: ... to operate in the FAST or STD mode the safe mode prevents operation of the handpiece Accessory Interface Connector provides power and communication for future accessories Symbol Definitions Slide the FAST STD Safe control to the FAST position to allow the handpiece to operate at high torque and high speed when the trigger is depressed Slide the FAST STD Safe control to the STD standard position t...
Страница 5: ... figure 1 Insert the blade into the slot Ensure the full insert line of the blade disappears in the blade retainer indicating the blade is positioned properly 1 2 3 4 Once the sagittal head is positioned release the index button and gently turn the sagittal head to ensure it is locked into position 2 WARNING To prevent the inadvertent running of the handpiece ALWAYS place the FAST STD safe control...
Страница 6: ...ce the FAST STD 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 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 t...
Страница 7: ...NTERVAL ACTIVITY Prior to each use Inspect operate and test the hand piece 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 vibra tions and note the operating speed Storage and Handling To ensure the longevity performance and safety of this equipment use the original packaging material...
Страница 8: ... the bat tery pack if required See the instructions supplied with the battery charger Blade will not fit into the blade retainer or cannot be secured Debris is inside the end of the blade retainer Clean the handpiece with a small brush Blade is not a Stryker product Use a Stryker blade Blade retainer is damaged Return the handpiece for repair Handpiece has become noisy and vibrates Blade is not a ...
Страница 9: ... 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 To Clean Battery Packs and Accessories See the care instructions supplied with the battery packs battery pack modules and battery charger Cleaning Recommendat...
Страница 10: ...the care instructions supplied 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 2...
Страница 11: ...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 Specifica...
Страница 12: ...ssions 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 ...
Страница 13: ...han 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 ma...
Страница 14: ...erial 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 UT 95 dip in UT for 0 5 cycle n a 40 UT 60 dip in UT for 5 cycles n a 7...
Страница 15: ... 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 t...
Страница 16: ...ts 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 6208 001 711 JA ZH KO 6208 001 721 SV DA FI PT NO 6208 001 731 EL PL 6208 001 751 ...
