Operators-Users Manual
17 Pages
Preview
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Operator’s / User’s Manual
© 2001-2004 All rights reserved. Kolster Methods, Inc.
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TABLE OF CONTENTS Table of Contents / Warnings
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Specifications
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General Information
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Warnings and Precautions
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Supplies
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Components
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Safety
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Care and Maintenance
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STARS Set-up
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STARS Set-up Continued
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STARS Set-up Continued
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STARS Set-up Continued
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Requesting Assistance
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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 3.5 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 : II 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.
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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 superior technology. To ensure years of trouble free operation, we deliver this operator’s / user’s manual. It is filled with valuable information on how to operate, maintain and order the manufacturer recommended supplies. Please readf this manual completely 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 information 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.
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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 education (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 amount 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 disposable components replaced before using the device system on another patient.
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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 3.7 mm x 30 cm Spiral cut cannula 4.2 mm x 35 cm Spiral cut cannula Luer-lock needle adapter
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Safety
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 case and top components of the device for obvious ssigns of shipping 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 disributors 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
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. 1. Shut down all power switches, disconnect from the main power source. 2. Remove the cannula from the hand piece. 3. Remove the suction tube from hand piece. 4. Rinse the inside of cannula and clean with brush. 5. Rinse inside of hand piece with warm water and brush, you may use a syringe if desired. ( DO NOT SUBMERGE HANDPIECE, EVER !!!) 6. Wipe items dry with clean soft towel and prep for sterilization. 7. Sterilization Protocol : A gas sterilization is preferred, following the standard office 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.
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STARS A/F ELITE set-up •
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 shipping 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 Front 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.
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STARS A/F Elite set-up
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 “│” position 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.
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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 footswitch “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.
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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).
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
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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 performance 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-transferable unless expressed by K.M.I. in written form.
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NOTES
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