Cytology Centrifuge Operator’s Manual Part of Thermo Fisher Scientific 582 Monroe Road, Suite 1424 Sanford, FL 32771 800-777-6668 · 407-788-8791 www.separationtechnology.com TABLE OF CONTENTS SECTION 1 INTRODUCTION 1.1 Description and Intended Use 1.2 Safety SECTION 2 UNPACKING AND INSTALLATION 2.1 Unpacking 2.2 Power Requirements and Power Cord Installation 2.3 Sealed Head Installation and Removal SECTION 3 OPERATING INSTRUCTIONS 3.1 Loading and Balancing the Sealed Head 3.2 Control Panel 3.3 Setting Up and Naming Programs 3.4 Accessing Saved Programs 3.5 Spinning the Samples 3.6 Unloading 3.7 Automatic Lid Lock - Manual Override 3.8 Standby Mode SECTION 4 MAINTENANCE 4.1 General Cleaning and Disinfecting 4.2 Sealed Head Cleaning and Disinfecting 4.3 Inspections 4.4 Speed Check 4.5 Timer Check 4.6 Service SECTION 5 TROUBLESHOOTING SECTION 6 ACCESSORIES SECTION 7 WARRANTY SECTION 8 SPECIFICATIONS SECTION 9 GLOSSARY SECTION 1 INTRODUCTION 1.1 DESCRIPTION AND INTENDED USE The SlidePrep Plus is a self contained, compact, sturdy centrifuge whose primary function is to produce a monolayer of cells onto a glass slide from any fluid suspension under the safest conditions possible. It effectively bypasses the difficulties normally associated with depositions obtained by direct smear or filtration. For In-vitro diagnostic use. This operator’s manual provides instructions for the correct operation and use of the SlidePrep Plus. 1.2 SAFETY STI products are designed for convenient and reliable operation and to accepted standards of safety. The use of the SlidePrep Plus does not entail any hazard if operated in accordance with the instructions given in the manual. However, incorrect actions by a user may damage the equipment or cause a hazard to health. It is important to comply with the following safety precautions. All users must read and understand the Operator’s Manual and only operate the instrument in accordance with the instructions. If the instructions are not followed, then the protection provided by the instrument may be impaired. Potentially lethal voltages above 110V a.c. or 50V d.c. are present inside the instrument. Do not remove any access covers unless specifically instructed to do so. This instrument must be properly connected to a good earth (Ground) via the mains input supply. The instrument should be positioned so that the disconnect device is easily accessible. Do not lean on the instrument. Do not remove any panels or covers. There are no user serviceable parts inside the instrument. The SlidePrep Plus is not intended for use with flammable materials or solvents, or with materials which could be explosive or chemically reactive. Always load and unload the sealed head in a biological safety cabinet. Assume that the samples are biologically hazardous. Do not stay in the clearance envelope longer than necessary for operation reasons. Do not deposit potentially hazardous material within the clearance envelope. Seals and other biosafety components cannot be relied upon as a sole safeguard against contamination by pathogenic micro-organisms. It is important that normal standards of safety and good laboratory practices are employed. Always use common sense and the best known practice when operating the instrument. Refer to your own laboratory procedures and manufacturer’s data sheets when using reagents. Contact Separation Technology Customer Service at 407-788-8791 with questions or concerns. 1 SECTION 2 UNPACKING AND INSTALLATION 2.1 UNPACKING The shipping box contains: Centrifuge Sealed head (slide holder, bowl and bowl lid) One sealed head is included with the instrument, but many laboratories shorten preparation time by having a second sealed head ready for when the first finishes processing. See Section 6, Accessories. Power cord set Latch tool Operator’s manual Place the instrument and other items in the box on a rigid and level bench made of a non-flammable material. 2.2 POWER REQUIREMENTS AND POWER CORD INSTALLATION The instrument has a built-in voltage selector switch which can be set for use on either 110V, 60Hz or 220V, 50Hz current. Locate this switch on the back of the instrument next to the power cord connector plug and check to see that it is set to the proper voltage for your electrical outlet. In the United States the proper setting is 110V. TO AVOID DAMAGE TO THE SELECTOR SWITCH, DO NOT ATTEMPT TO CHANGE THE VOLTAGE WHILE THE POWER CORD IS PLUGGED INTO AN ELECTRICAL OUTLET. If the voltage selector switch is at the improper setting, unplug the instrument, insert a flat head screwdriver into the slot of the switch and turn it to the proper setting. Plug the instrument power cord into the power connector at the rear of the instrument, then into a grounded power outlet rated at the appropriate voltage. To avoid equipment damage and/or electrical shock hazards, connect power cord only to a three-wire grounded receptacle. 2.3 SEALED HEAD INSTALLATION AND REMOVAL To install the sealed head, position it onto the motor coupling. To remove the sealed head, pull up on the knob. 2 SECTION 3 OPERATING INSTRUCTIONS Prepare samples as required. Samples are centrifuged in reusable or disposable concentrating funnels, or in concentrating funnels that include a filter material to absorb and capture suspension fluid during cytocentrifugation. The SlidePrep Plus accepts Shandon or equivalent concentrating funnels. See package inserts for instructions for use. Not for use with Shandon Megafunnel™ or equivalent. Make sure the power switch, which is located at the rear of the instrument, is in the ON position. 3.1 LOADING AND BALANCING THE SEALED HEAD Place the funnels into the sealed head. Make sure they are distributed evenly so that the SlidePrep Plus is balanced. Empty funnels may be used for balance. If the instrument is run out of balance, the program will be aborted and an alarm will beep once per second until the On/Off switch is cycled. An imbalance message will display. Load the funnels after they have been inserted into the sealed head. Do not place more than 0.5ml of a sample in a Cytofunnel sample chamber with white filter card (0.4ml for a Cytofunnel sample chamber with brown filter card). Make sure that the sample is deposited directly into the bottom of the sample chamber. Do not allow the sample to drip down the sides of the chamber. Replace the bowl lid and tighten the knob. Carefully install the sealed head onto the center of the instrument. Lock the instrument lid by pressing down firmly on the lid tab. TO AVOID AN OUT OF BALANCE ERROR MAKE SURE THAT THE FUNNEL ASSEMBLIES ARE EVENLY DISTRIBUTED IN THE SEALED HEAD TO ENSURE THE SEALED HEAD IS BALANCED. ALWAYS KEEP THE SEALED HEAD LEVEL WHEN IT CONTAINS SPECIMENS. ALWAYS LOAD AND UNLOAD THE SEALED HEAD IN A BIOLOGICAL SAFETY CABINET. AFTER SPINNING, TAKE THE SEALED HEAD TO THE SAFETY CABINET TO OPEN IT. THIS IS PARTICULARLY IMPORTANT IF THE SAMPLES UNDER INVESTIGATION CONTAIN, OR COULD CONTAIN, PATHOGENIC MICRO-ORGANISMS. BE AWARE OF SAMPLES USED. THEY MAY POSE A BIO HAZARD. UNIVERSAL PROCAUTIONS SHOULD BE FOLLOWED ON ALL SPECIMENS, REGARDLESS OF WHETHER THE SAMPLE IS KNOWN TO CONTAIN AN INFECTIOUS AGENT. MAKE SURE THAT THE LID IS SECURELY FITTED. 3.2 CONTROL PANEL The control panel is situated on the front of the instrument. The main menu displays: Spin time (1-99 minutes) RPM (250-2400 rpm) RCF (Relative centrifugal force) Program name 3 Acceleration rate (slow, medium or high) Status o Lid Open o Lid Closed o Starting o Running Program (name) o Imbalance (centrifuge will stop spinning and a beep will sound once per minute until the On/Off switch is cycled) o Low RPM (displayed if rpm drops 10% below the set rpm) o High RPM (displayed if rpm is 10% above the set rpm) o Failure Call STI o Complete Main Menu Display 3.3 SETTING UP AND NAMING PROGRAMS Up to 25 programs can be saved. To set up a new program, select the desired settings as described below. When changing the settings, ~ will display in the upper right corner indicating that the program settings displayed have not been saved. When the program is saved, the ~ will disappear. Enter the time by pressing [TIME]. The time digits will be underlined. The [UP] arrow will increase the time 1 minute each time it is pressed. The [DOWN] arrow will decrease the time 1 minute each time it is pressed. If either arrow is held down, the time will increase or decrease in steps of 5 minutes. Press [SAVE] to save the time setting under the current program name and return to the main menu. Press [START] to begin the run. Press [STOP] to return to the main menu. Enter the RPM by pressing [SPEED]. The RPM digits will be underlined. The [UP] arrow will increase the speed 10 rpm each time it is pressed. The [DOWN] arrow will decrease the speed 10 rpm each time it is pressed. If either arrow is held down, the speed will increase or decrease in steps of 50 rpm. Press [SAVE] to save the speed setting under the current program name and return to the main menu. Press [START] to begin the run. Press [STOP] to return to the main menu. SlidePrep Plus ‘g’ Forces RPM 250 300 350 400 450 500 550 600 650 RCF RPM 1350 1400 1450 1500 1550 1600 1650 1700 1750 8 11 14 18 22 26 31 37 4 RCF 159 171 184 197 210 224 238 252 268 700 750 800 850 900 950 1000 1050 1100 1150 1200 1250 1300 43 49 56 63 71 79 87 96 106 116 126 137 148 1800 1850 1900 1950 2000 2050 2100 2150 2200 2250 2300 2350 2400 283 299 315 332 349 367 385 404 423 442 462 482 503 May vary slightly Choose the rate of acceleration by pressing [ACCEL]. One of the three selectable acceleration settings - SLOW, MEDIUM, and HIGH will be underlined. These settings change the time in seconds required for the sealed head to reach the selected RPM after pressing [START]. Acceleration/Deceleration Table RPM Slow Medium High Deceleration Time 500 9 sec 7 sec 6 sec 11 sec 1000 20 sec 15 sec 10 sec 15 sec 1500 29 sec 22 sec 17 sec 17 sec 2000 39 sec 30 sec 24 sec 20 sec 2400 44 sec 35 sec 26 sec 23 sec The deceleration time may vary slightly depending on the number of slides being spun. Use the arrows to step through the settings until the desired acceleration setting is displayed. Press [SAVE] to save the acceleration setting under the current program name and return to the main menu. Press [START] to begin the run. Press [STOP] to return to the main menu. Save the parameters that have been entered with the program name displayed, by pressing [SAVE]. Note that this will overwrite the program information previously saved under that program name. Press [START] to begin the run. To name a program, save the parameters that have been entered with a new program name, by pressing [PROG] twice. The last program name used will display with an arrow under the first character. Naming a Program Display Program names may consist of numbers and/or letters with a maximum of 8 characters. Use the [UP] and [DOWN] arrows to increment to the next character. To move the arrow one space to the right, press [SPEED] once. To insert a blank space press [SPEED] a second time. To backspace press [TIME]. The arrow will point to the character selected. Once the desired name is entered press [SAVE] to save the program and return to the main menu. The last program run will always be displayed on the main menu even if the instrument has been powered off and on. 3.4 ACCESSING SAVED PROGRAMS To access a saved program, from the main menu press [PROG]. The program selection screen will display. Program 01 is a default program and is always displayed as Program 01. Program numbers 02 to 25 do not have parameters set. 5 Selecting a Program Display Use the [UP] and [DOWN] arrow keys until the desired program is displayed. Press [START] to run the program. Press [STOP] to return to the main menu. Press [ACCEL] to delete the program. Press [PROG] to set up or edit the program. 3.5 SPINNING THE SAMPLES With the sealed head properly seated in the instrument and the lid locked, press [START] to begin the timed cycle. When the cycle is complete, the sealed head will stop, three beeps will be heard, and the instrument lid will open automatically. Do not attempt to open the lid during operation. Three beeps will sound every few seconds until the user presses [STOP]. 3.6 UNLOADING Once the instrument lid has automatically opened, remove the sealed head to a biological safety cabinet. Only open the sealed head assembly in a biologically safe cabinet. Fix the samples as soon as possible to avoid autolysis. The specimens can now be stained and examined according to laboratory procedures and examined microscopically. BE AWARE OF SAMPLES USED. THEY MAY POSE A BIO HAZARD. 3.7 AUTOMATIC LID LOCK - MANUAL OVERRIDE You may manually override the instrument automatic lid lock by turning the power switch off, waiting 5 seconds and turning it back on, or by inserting the L - shaped latch tool into the small hole on the right side of the instrument, pushing gently until the lid opens. 3.8 STANDBY MODE Press [STANDBY] to switch the instrument into standby mode. A log history will display as the instrument is shutting down. Press [STANDBY] again to restart the instrument. The last program run will be displayed. Standby Display 6 SECTION 4 MAINTENANCE 4.1 GENERAL CLEANING AND DISINFECTING As with all electrical devices, make sure the instrument is unplugged before cleaning. Always wear protective clothing when using any cleaning materials. NEVER USE BLEACH, ABRASIVES OR CORROSIVE SOLVENTS TO CLEAN. DO NOT SPRAY OR ALLOW ANY LIQUID TO GET INSIDE THE INSTRUMENT. LIQUID WILL HARM THE ELECTRONICS. SUBSEQUENT PROBLEMS WILL NOT BE COVERED UNDER WARRANTY. Use a cloth slightly dampened with a non-corrosive disinfectant solution to clean the lid, front panel and other parts of the instrument housing. Dry all surfaces with a soft tissue or cloth after cleaning. If hazardous material is spilled on or inside the SlidePrep Plus, the user should carry out the appropriate decontamination. 4.2 SEALED HEAD CLEANING AND DISINFECTING IT IS IMPORTANT THAT THE INSTRUCTIONS FOR THE SEALED HEAD ARE FOLLOWED IF THE SEALED HEAD IS TO CONTINUE TO ACT AS AN EFFECTIVE BIOSAFETY SEAL. Autoclave all parts of the sealed head at 121◦C (250◦F) for 15 minutes daily, if necessary and immediately after serious spillage. Unlock the lid so that the steam can fully penetrate the interior. After autoclaving, wash the sealed head components and accessories in warm soapy water. Dry in an oven at a temperature not exceeding 65°C (149°F). Check that no parts are cracked or damaged. 4.3 INSPECTIONS Periodically inspect the protective casing to ensure there are no cracks or damage. Prior to use, inspect the bowl seal for wear, stretching or damage and replace annually. To remove the bowl seal, simply pull the old bowl seal off of the rim of the bowl. To fit the bowl seal, place the groove of the replacement seal over the bowl lip. See Section 6, Accessories for ordering information. 7 4.4 SPEED CHECK Check the motor speed with a calibrated tachometer. The speed is acceptable if it is within + 5% of the speed setting. 4.5 TIMER CHECK Check the minute timer with a calibrated stop watch. Press [START] on the instrument. Start the stop watch when the time count begins to count down. Stop the stop watch when the time count reaches zero. The time is acceptable if it is within ± 3 seconds of the set spin time. 4.6 SERVICE For service, call Separation Technology Customer Service at 407-788-8791 for a Return Authorization Number and a Certificate of Decontamination and Cleaning. All instruments or accessories must be cleaned and decontaminated prior to shipment to the manufacturer for service. This decontamination is required by Federal law and EPA regulations. Employees of Separation Technology cannot perform this decontamination. 8 SECTION 5 TROUBLESHOOTING Symptom Instrument will not spin Problem Solution Lid not locked Press down firmly on lid tab Lid lock is engaged Disengage lid lock (See Section 3.7) Instrument is in the spin cycle Allow spin cycle to end (See Section 3.5) The program aborts, a beep sounds once per second and the status shows Imbalance Sealed head out of balance Cycle On/Off switch and balance sealed head (See Section 3.1) Instrument vibrating abnormally during spin cycle Sealed head out of balance Balance sealed head (See Section 3.1) Instrument power switch is off Turn power on Instrument not plugged into electrical outlet Plug power cord into electrical outlet (See Section 2.2) Voltage selector switch not set properly Select proper input voltage.(See Section 2.2) Blown fuse Replace fuse with proper replacement type No power at outlet Contact facility maintenance Lid will not open Instrument will not operate. If the SlidePrep Plus Centrifuge fails to operate correctly after following the above procedures, call Separation Technology Customer Service at 407-788-8791. 9 SECTION 6 ACCESSORIES Catalog # 230-411 230-407 230-400 230-409 230-405 230-412 230-413 230-404 230-403 230-406 230-408 230-409 230-415 230-402 230-401 230-410 Description Closure Cap, TPX Chamber, 12/pkg Cytoclips, SS, 6/pkg Double Cytology Funnel, White, 25/pkg EZ Double Cytofunnel, 200/pack EZ Double Cytofunnel, White, 40/pkg EZ Funnel Starter Kit, Shandon EZ Single Cytofunnel, 200/pack EZ Single Cytofunnel, Brown, 40/pkg EZ Single Cytofunnel, White, 40/pkg EZ Cytofunnel Stand Filter Card, Brown, 200/pkg Filter Card, White, 200/pkg Single Cytofunnel, Caps, 500/case Single Cytology Funnel, White, 50/pkg Single Cytology Funnel, Brown, 50/pkg Single Cytology Funnel, White, 500/case 550-100 550-101 120V Power Cord. 3 prong NEMA 5-15P Plug 230V Power Cord, 8 ft. 2 prong Euro Plug 200-400 720-400 Complete Sealed Head Bowl Lid Seal 910-400 640-116 Operator's Manual Latch Tool 10 SECTION 7 WARRANTY SEPARATION TECHNOLOGY, INC. (STI) warrants each new SlidePrep Plus™ Centrifuge (the Product) against defects in materials or workmanship for a period of two years from the date of purchase and agrees to repair or replace any defective Product without charge. This warranty does not cover damage resulting from accident, misuse, lack of reasonable care, improper cleaning, improper maintenance or improper packaging for return shipment to STI. This warranty shall be void if the Product is repaired by anyone other than STI. This warranty does not extend to anyone other than the original purchaser or to accessories manufactured by other vendors. Except as provided herein, STI makes no warranties of any kind, either express or implied and specifically excluding any warranty of merchantability or warranty of fitness for a particular purpose. STI will not be liable for any special, consequential or incidental damages arising out of the use or inability to use the Product. In no event shall STI's liability hereunder exceed the purchase price of the Product. This warranty shall be void and of no force and effect with respect to any Product which is damaged as a result of a) neglect, alteration, electric current fluctuation or accident, b) improper use, including failure to follow proper operation and maintenance, and to provide proper environmental conditions prescribed in STI's Product operator’s manuals, c) repair by other than STI or authorized service agents appointed by STI and acting in accordance with STI's service announcements or d) use of supplies or parts which do not meet STI specifications. To obtain warranty service, call Separation Technology Customer Service at 407-788-8791. 11 SECTION 8 SPECIFICATIONS Model number: Recommended use: Slide holder: Maximum slide holder capacity: Motor: On/Off switch: Electrical supply voltage: Power cord: Dimensions (WxLxH): Clearance area requirements (WxLxH): Weight: Operating noise level: Temperature range: Conditions: Approvals: 100-400 Produce a monolayer of cells onto a glass slide from any fluid suspension Sealed head Six filled Cytofunnels Brushless Located at the rear of the instrument 120V 60Hz ± 10% 150W 120V Fuse, 1.25 amp (5 x 20mm) Type 218 Slo Blo 230V 50Hz ± 10% 150W 230V Fuse, .63 amp (5 x 20mm) Type 218 Slo Blo Grounded cord with 3-prong NEMA 5-15p plug 10" x 15" x 10" 15" x 18" x 20" 10 lb. Less than 65 db Operating 10°C (50°F) to 40°C (104°F) Storage -10°C (14°F) to 60°C (140°F) For indoor use only. Maximum relative humidity 95% non-condensing ETL/CETL Listing for North America UL 61010-1 CAN/CSAC22.2#61010-1 IEC 61010-1 CENELEC EN 61010-1 IEC 61010-2-020 12 Section 9 GLOSSARY SYMBOL USED FOR SYMBOL USED FOR Start There may be a biohazard associated with the instrument Stop Caution. Instructions must be followed for safe and correct operation. Up Consult Instructions For Use Down Manufacturer Time Temperature Limitation Speed Serial Number Accelerate Catalog Number Program In vitro Diagnostic Medical Device Save European Community Authorized Representative Standby 13 910-400E 07/2011 Manufactured by: Separation Technology, Inc. 582 Monroe Road, Suite 1424 Sanford, FL 32771 www.separationtechnology.com Made in USA
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