Cytofuge®12 Cytocentrifuge System Operator’s Manual A Division of IRIS International, Inc.
Operator’s Manual Cytofuge®12 Cytocentrifuge System Model Number M802 For in-vitro diagnostic use Product Number CF12 – Cytofuge 12 for 100-240 VAC, 50/60 Hz StatSpin and Iris are registered trademarks of IRIS International, Inc. Copyright 2009 Printed in U.S.A.
Table of Contents How to use this manual ...................................................................................... ii Section 1 ............................................................................................................. 1 Inspect Packaging .......................................................................................... 1 Verify Contents ............................................................................................... 1 Install ..........................
How to use this manual This manual along with information contained on product labels and in package inserts should provide you with all the information you need to operate and maintain the Cytofuge 12 Cytocentrifuge system. When the information requires special attention, a caution symbol text.
CAUTION – Do not lean, or place materials, on the cytocentrifuge. CAUTION - Follow Universal Precautions with all biological specimens, regardless of whether the specimen is known to contain an infectious agent. Bioseals cannot be relied upon as a sole safeguard against contamination by pathogens. Always load and unload the rotor under a biological safety hood. (See references). CAUTION – The seals in the removable rotor are intended to stop gross fluid leakage only.
Section 1 Unpacking and Installation Inspect Packaging The Cytofuge® 12 Cytocentrifuge and its accessories are delivered in a single carton. If the cytocentrifuge or accessories have been damaged in transport, please inform your carrier immediately. NOTE: Save the shipping carton and packing materials to facilitate return should service be required.
Connect Power o Plug the cytocentrifuge into a grounded outlet supplying 100-240 V @ 50-60 Hz. o Turn on the power switch (located on the rear panel, above the line cord connector). o When the Cytofuge 12 completes the power-on check it will give a two-beep ready signal. Press the STOP/OPEN button to release the latch and open cover. WARNING - Do not use the supplied line cord outside of North America.
Section 2 System Overview Principle and Intended Use IVD For in vitro diagnostic use in concentrating cells onto a microscope slide. The Cytofuge® 12 Cytocentrifuge is a microprocessor-controlled cell preparation system that uses centrifugal force to deposit cells onto microscope slides.
Operator Controls Start Stop/Open Initiates the selected cycle Interrupts the cycle and releases the cover when the rotor has stopped. Cancels Programming Mode Save Enters Programming Mode to store speed, time and acceleration settings Acceleration Select Depress to select acceleration profile - Low, Medium or High Up Increments program, speed or time Down Decrements program, speed or time CONTROL PANEL To change the cycle speed use the arrow keys to the right of the SPEED display.
Error Indicators Cytofuge® 12 Cytocentrifuge error conditions are signaled by flashing codes appearing in the TIME display on the front panel. To clear an error condition, correct the problem and press the Stop/Open button. Error Codes Acceleration Error Confirm no obstruction in bowl area, check drive cone o-rings (see Section 5), contact customer service. Latch is not locked Confirm cover is fully seated in closed position.
Section 3 Sample Requirements/Preparation Overview The approximate cell concentration of the specimen should be established prior to slide preparation on the Cytofuge 12. Samples containing higher than optimal cell concentration will produce slides with cells too closely packed or overlapping. Samples containing too low a cell concentration will yield slides where cells are difficult to find, count, or examine.
Section 4 Operating Instructions Opening and Closing the Cover An electronic operated cover interlock mechanism prevents operation if the cover is not completely closed and locked, and prevents the cover from opening when the rotor is turning. An operating cycle can be initiated only if the cover latch is engaged. Cover Interlock By-pass In case of power failure or malfunction, the Stop/Open button may not release the cover.
Spinning Samples CAUTION – Maintain a 300 mm (11.8 inches) clearance envelope around cytocentrifuge during operation. Do not deposit any potentially hazardous materials within the clearance envelope. CAUTION – Do not lean, or place materials, on the cytocentrifuge. CAUTION – The seals in the removable rotor are intended to stop gross fluid leakage only. These seals should not be relied upon for protection against biohazardous contamination.
Cytofuge 12 operating parameters generally depend upon the size and specific gravity of the cells to be concentrated onto the microscope slide. The operator should experiment with different settings to achieve optimum performance for specific applications. The following are general guidelines: Application Speed Range (RPM) Time Range Cytology 400 to 650 2 to 4 minutes Hematology 650 to 1500 4 to 8 minutes Microbiology 1000 to 2000 4 to 10 minutes For fragile cells, reduce speed.
Section 5 Maintenance Overview Iris Sample Processing recommends that instrument operators perform periodic inspections and preventative maintenance on all instruments. Contact customer service or your distributor for optional repair and calibration services offered for this instrument. CAUTION - Unplug the cytocentrifuge from the wall outlet before cleaning or performing maintenance. WARNING - Inspect instrument for cracks or any physical damage to housing, cover, lid and rotor.
Checking/Replacing Rotor Seal Over time seals may become brittle and develop cracks. To ensure optimal rotor performance, check the inner and outer seals of the rotor regularly for any tears or cracks. The center seal is user replaceable. The outer seal is part of the rotor bowl – if this seal becomes worn or damaged a new rotor bowl should be purchased.
Checking the Rotor Speed Rotor speeds (+5%) may be checked with a stroboscope or photoelectric tachometer. 1. Remove the rotor and locate the reflective patch located on the top of the drive cone. Close the instrument cover. 2. Set the instrument to the desired speed. 3. Point the tachometer through the transparent cover at the reflective patch. 4. Press the Start button. Allow the instrument sufficient time to reach speed before making a measurement.
Service Refer all service to Iris Sample Processing or an Authorized Repair Facility. Instrument fuse(s) are located on the rear panel. Remove the line cord to access the fuse holder. Replace with fuses of the same type and rating. 2.5A 250V F 5 x 20 mm Be sure to complete the Warranty Registration Card as directed.
Section 6 Appendix Specifications ® Product Name Cytofuge 12 Cytocentrifuge Product No. CF12 Model No. M802 Capacity 12 Filter and/or Cell concentrators Programs 24 user configurable Speed Range Accuracy 200-2000 rpm Time Range Accuracy 1-99 minutes Acceleration Range Deceleration Fixed ± 5% ± 2 seconds LO (45-50 RPM/sec); MED (65-70 RPM/sec); HI (85-90 RPM/sec) < 1min 100 – 240 VAC, 50/60Hz, 2.5 A Electrical 300 W Physical Height: 8.0“ (20.3 cm) Width: 13.0” (33.0 cm) Depth: 16.
References 1. CLSI. “Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Third Edition.” CLSI document M29-A3 [ISBN 1-56238-567-4]. CLSI, 940 West Valley Rd, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005. 2. CDC. Recommendations for Prevention of HIV Transmission in Health Care Settings. MMWR (Suppl. No. 2S):2S-18S, 1987. 3. CDC.
Iris Sample Processing Warranty Iris Sample Processing, a Division of IRIS International, Inc. warrants that the cytocentrifuge shall be free from defects in material and/or workmanship, under normal use and service, for the period expiring Twelve (12) months from the date of installation.