Operator`s / User`s Manual - "KMI" KOLSTER METHODS
Contents
1. 2001 2004 All rights reserved Kolster Methods Inc Specification Danger Warning If the equipment is used in a manner not specified by the manu facturer the protection provided by the equipment may be impaired Specifications Danger Advertissements Si cet equipement n est pas utilise selon les directives du fabri cant le bon fonctionnement de appareil risque d etre compromis Technische Daten Warnhinweise Wenn dieses great nicht nach vorschriften des herstellers ange wendet wird ist die garantie hinfallig Especificaciones Peligro Advertencias Si el equipo es utilizado de manera no especificada por el fabri cante la proteccion que ofrece el equipo puede verse afectada Page 2 TABLE OF CONTENTS Table of Contents Warnings 3 Specifications 4 General Information 5 Warnings and Precautions 6 Supplies T Components 8 Safety 9 Care and Maintenance 10 STARS Set up 11 STARS Set up Continued 12 STARS Set up Continued 13 STARS Set up Continued 14 Requesting Assistance 15 Federal USA law restrict this device to sale by or on the order of a physician or surgeon ELECTRICAL SHOCK HAZARD DO NOT REMOVE COVER Refer servicing to qualified service personnel EXPLOSION RISK if used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Page 3 SPECIFICATIONS INDOOR USE ONLY Weight 14 LBS Physical Dimensions 12 in x 8 5 in x 32. Requesting Assistance If you need assistance service ordering supplies or general questions on the STARS please feel free to contact our Global Headquarters at 951 737 5476 and ask for technical support We are always happy to hear from our valued customers For a complete listing of all K M I authorized distributors and service Centers contact K M I Global Headquarters and ask for sales Be sure to visit our web site www featherlift com Page 15 WARRANTY K M I STARS AF Elite is warranted free of defects in material and workmanship under normal use and operation for a period of 1 one year 90 days for hand piece under terms and conditions of the K M I warranty in place at the time of purchase During the warranty period K M I will repair or replace at its sole option free of charge any defective parts or products returned with prior authorization to K M I Warranty does not cover products abused misused or altered outside of the factory location or devices not utilizing K M I Supplied components devices and supplies intended for the proper operation of the equipment unless authorized by a representative of K M I There are no obligations on the part of K M I for consequential damages arising out of or in connection with the use or perform ance of the product K M I disclaims all implied warranties of merchantability and of fitness for a particular purpose The warranty is non negotiable and non trans
3. case and top components of the device for obvious ssigns of ship ping damage If any of the components are damage or you suspect any damage do not connect the STARS to an electrical power source Contact K M I or your distributor ASAP To ensure proper electrical grounding of your STARS be sure that your power source is marked Hospital Grade There are no user serviceable components inside of the device enclosure Always refer to qualified service technician for service Always refer any service to K M I or one of our authorized dis ributors to prevent voiding the warranty If you should attempt to service the Device always DISCONNECT the main power prior to performing any service Page 9 VC B N N O Care and Maintenance Prior to cleaning with any solution be sure to Disconnect the STARS from its main power Source to prevent electrical shock Instructions for cleaning and sterilization of the hand piece and cannula Shut down all power switches disconnect from the main power source Remove the cannula from the hand piece Remove the suction tube from hand piece Rinse the inside of cannula and clean with brush Rinse inside of hand piece with warm water and brush you may use a syringe if desired DO NOT SUBMERGE HANDPIECE EVER Wipe items dry with clean soft towel and prep for sterilization Sterilization Protocol A gas sterilization is preferred following the standard of
4. 5 in in inches Power Requirements 85 VAC to 264 VAC Mains Power Input Fusing 1 T 1 0A 250V Operating Temperature Range 5 Centigrade to 40 Centigrade Humidity non condensing Maximum relative humidity 80 for temperaturew up to 31 centigrade Decreasing linearly to 50 relative humidity at 40 centigrade Installation Catogory Il per IEC 664 Pollution Degree 2 per IEC 664 Safety EN55011 March 1991 EN50082 1 Jan 1991 EN61010 April 1993 IEC60601 1 1998 ISO 10079 1 Electro Magnetic Compliance 73 23 EEC 93 68 EEC Protection Against Electrical Shock Class 1 Type BF Enclosure Rating Ordinary Equipment Atmospheric Pressure Range 500 Hpa to 1060 Hpa Chemical Resistance All materials will withstand mild didinfectant solution or cleaning solvents NON ABRASIVE DANGER WARNING EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS Page 4 Thank you for purchasing a K M I Soft tissue Advanced Rotary Sculptre System Because your office is getting busier and your procedures more demanding K M I has developed the STARS K M I s STARS will save you time and money while delivering su perior technology To ensure years of trouble free operation we deliver this operator s user s man ual It is filled with valuable information on how to operate maintain and order the manufacturer re commended supplies Please readf this manual com pletely
5. and carefully Please record your STARS information in the Spaces provided below When calling for technical service or customer support some or all of this in formation may be required to expedite your needs Model No AF Elite Serial No Purchase Date Purchased From This information may be found on your packing slip and or the side of the unit Page 5 Warning and Precautions WARNING 1 This device will not in and of itself produce significant weight reduction 2 This device should be used with extreme caution in patient with chronic medical conditions such as diabetes heart lung or circulatory system disease or obesity 3 The volume of blood loss and endogenous body fluid loss may adversely affect intra and or postoperative hemodynamic stability and patient safety The capability of providing adequate timely replacement is essential for patient safety Precautions 1 This device is designed to contour the body by removing localized deposits of excess fat through small incisions 2 Use of this device is limited to those physicians who by means of formal professional traing and sanctioned continuing medical edu cation including supervised operative experience have attained proficiency in suction lipoplasty 3 Results of this procedure will vary depending upon patient age surgical site and experience of the physician 4 Results of this procedure may or may not be permanent 5 The am
6. ferable unless expressed by K M I in written form Page 16 NOTES Page 1
7. fice protocol or the device is to be sterilized in a steam autoclave at a temperature of 275 Fahrenheit for a period of 15 minutes The device is to be sterilized in a sealed pouch approved for steam sterilization Visually inspect the main power cord on a periodic basis to ensure serviceability Should any breaks or tearing in the insulated rubber Jacket appear or any cracks in the connection body of either end of the cord set DO NOT USE discard immediately and order a new cord set from K M I Do not use any cord set other than that from the manufacturer The cord set is specifically designed to handle the current draw required by your device Page 10 STARS A F ELITE set up e The aspiration device used with the STARS must have a minimum Of 1 3 horsepower 6 scfm an available vacuum range of 0 29 8 inches Hg a fully adjustable High Low vacuum control setting an inline microbial filter between aspirator collection canister and one at exhaust end of aspirator Prior to set up your STARS be sure to inspect the device for ship ping damage Place the power unit on a flat level surface where you plan to use the device during surgery Utilizing the usual sterile procedures technique connect any sterile PVC suction tubing 1 4 3 8 ID and a minimum of 6 feet in length to the hose barbed fitting on the proximal end of the STARS hand piece connect the other end to your vacuum source Connect the hand piece cable to the Fron
8. itch ON button should footswitch fail or become lost you can override footswitch by depressing RUN in the motion block lower center Page 13 STARS A F Elite set up Speed and angle may be changed while cannula is running or while stationary adjustments must be made 1 increment at a time Please wait for device to complete its audio announcement before making another setting change Audio announcements may be turned off by depressing the OFF button in the Audio Feedback block center right position Procedure timer is located in the upper right position If you are using special cannula that require orifice orientation after attaching cannula to hand piece adjustments can be mede by depressing the JOG button then depressing and holding down the INDEX button until desired position is achieved Depress OSC to return to the oscillation mode Page 14 STARS A F Elite shut down To shut down the power cannula system complete the following in this order To shut down the system stop cannula motion by stepping on footswitch If in override mode depress the STOP button lower center Depress the O button lower left main power block On the bottom of the device place the main power switch in the OFF O position Disconnect footswitch from front panel Unscrew hand piece locking ring Pull hand piece connection straight out DO NOT TURN OR TWIST CONNECTION EVER
9. ount of fot removed should be limited to that necessary to achieve the desired cosmetic effect 6 All reusable components of the device must be sterilized and all dis posable components replaced before using the device system on another patient Page 6 Components Driver Controller a 9 Lbs sa Universal Voltage 2 ss Controls Motion Jog Oscillating Speed 60 90 120 175 Angle 90 180 360 720 Page 7 Components Hand piece Comes with cable pre attached Straight through design Autoclavable Cannula Pack Cannula below or 5 of your choice 2 0 mm x 20 cm Spiral cut cannula 2 5 mm x 20 cm Spiral cut cannula 3 0 mm x 25 cm Spiral cut cannula 3 mm x 30 cm Spiral cut cannula 4 2 mm x 35 cm Spiral cut cannula Luer lock needle adapter Page 8 CAUTION THE SPIRAL CUT CANNULA SHOULD BE USED WITH EXTREME CAUTION IN AREAS OF SUPERFICIAL MOTOR NERVE PATHS Prior to any operation of the STARS be sure you have read and completely understood all instructions pertaining to the device Training on the safe and proper use of the device is always your best safety feature If at any time during the operation of the STARS you feel any unsafe condition has occurred discontinue use and contact us immediately Please pay close attention to the instructions given through out this manual Remove the STARS from the shipping carton Please keep any and all shipping material that came with your device Inspect the outer
10. t of the STARS driver unit On The hand piece cabled connector you will see a red orientation dot You will also see a red orientation dot at the connection point of the STARS driver unit Be sure to line up the red dots then insert the cable connections together Turn on the cable security ring to ensure secure connection NOTE The device will not activate unless this ring is securely in place Page 11 STARS A F Elite set up ot 3 ee eo E J gt as RE rt On the bottom of the device please note the mains power on off switch Be sure the device is in the off position This is the position where the O on the switch is depressed The posi tion is the on position On the bottom of the device connect the supplied power cord into the power entry module plug other end into wall outlet marked hospital grade After power cord is connected place the main power switch in the ON position Page 12 STARS A F Elite set up Locate and visually inspect the footswitch cable and cable connection Do not use if any damage is noted The footswitch receptacle is located on the front face just right of hand piece port Attach footswitch here Main Control Panel To activate the device depress the button in the main power block in the lower left corner Device will default to the lowest speed and angle available In the lower right corner depress the footsw
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