IRIS Cytofuge 12 User manual

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.

i
Table of Contents
How to use this manual......................................................................................ii
Section 1.............................................................................................................1
Inspect Packaging..........................................................................................1
Verify Contents...............................................................................................1
Install..............................................................................................................1
Connect Power...............................................................................................2
Section 2.............................................................................................................3
Principle and Intended Use ............................................................................3
Symbols and Definitions.................................................................................3
Operator Controls...........................................................................................4
Error Indicators...............................................................................................5
Accessories....................................................................................................5
Section 3.............................................................................................................6
Overview ........................................................................................................6
Sample Volumes ............................................................................................6
Pre-concentration...........................................................................................6
Dilution ...........................................................................................................6
Section 4.............................................................................................................7
Opening and Closing the Cover .....................................................................7
Using the Removable Rotor ...........................................................................7
Spinning Samples...........................................................................................8
Programming..................................................................................................9
Section 5...........................................................................................................10
Overview ......................................................................................................10
Cleaning.......................................................................................................10
Checking/Replacing Rotor Seal....................................................................11
Checking/Replacing Drive Cone O-rings......................................................11
Checking the Rotor Speed ...........................................................................12
Troubleshooting............................................................................................12
Service .........................................................................................................13
Section 6...........................................................................................................14
Specifications ...............................................................................................14
References...................................................................................................15
Iris Sample Processing Warranty .................................................................16
Limitation of Liability.....................................................................................16

ii
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 appears next to the italicized
text.
Please pay close attention to the instructions that accompany the notes and symbols as well as the
standard laboratory practices outlined by your facility and local regulatory agencies. The table below lists
all the CAUTIONS and WARNINGS for the Cytofuge®12 Cytocentrifuge.
WARNING - Do not expose the cytocentrifuge or its rotor to strong or concentrated acids, bases or
oxidizing agents, aromatic or halogenated hydrocarbons, esters or ketones.
WARNING - Do not use the supplied line cord outside of North America.Use a power cord with a
grounded male connector suitable for the power outlet being used, which is rated at 3.0 Amps or more
and has an IEC320/CEE22 female connector to attach to the cytocentrifuge.
WARNING - Maintain a 300 mm (11.8 inches) clearance envelope around cytocentrifuge during
operation. Do not deposit any potentially hazardous materials within the CLEARANCE ENVELOPE.
WARNING - Inspect instrument for cracks or any physical damage to housing, cover, lid and rotor.
Damage may result in unsafe operation; discontinue use until repairs have been performed.
CAUTION - Do not overfill the concentrators. Addition of excess amounts of liquid to Cell or Filter
Concentrators will result in the fluid being “spun out” during centrifugation.
CAUTION - Do not place the cytocentrifuge on top of other equipment and do not place other objects or
equipment on top of the cytocentrifuge.
CAUTION - The cover interlock by-pass is for emergency use only. Do not attempt to operate the
Cytofuge 12 while the latch release tool is inserted in the housing. Misuse of the interlock bypass may
expose the operator to unsafe conditions.
CAUTION - Before using any cleaning or decontamination methods except those recommended,
operators should check with customer service that the proposed method will not damage the
equipment.
CAUTION - The rotor (CFRT-12) is designed for many years of service but, depending on the
frequency of use, the rotor components may develop cracks over time or if dropped on a hard surface.
Inspect the rotor for damage or cracks before each use. If damage is found discontinue use and
contact customer service or your distributor for a replacement.
CAUTION - Do not lift the rotor (CFRT-12) by the locking button - the lid may release allowing the rotor
bowl to fall. Always lift the rotor by the black center grip.
CAUTION - The rotor (CFRT-12) is intended for use with biological samples only. Do Not place
flammable or reactive substances in the rotor.
CAUTION - While in the resting position, the rotor is designed to maintain the Concentrators at an
angle to prevent fluid from contacting the slide and/or the filter card prior to spinning. Keep the rotor
level during transport to and from the cytocentrifuge to ensure proper concentrator angle.
CAUTION - Do not defeat any safety interlocks while checking the rotor speed. Bypassing interlocks
could result in personal injury.
CAUTION - Unplug the cytocentrifuge from the wall outlet before cleaning or performing maintenance.

iii
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. These
seals should not be relied upon for protection against biohazardous contamination.
Please use the system as intended. Improper use of the Cytofuge®12 Cytocentrifuge and/or its
accessories may cause personal injury, damage to the system, inaccurate results, or potentially nullify
warranties.
The Cytofuge®12 Cytocentrifuge System, and its associated components and consumables are covered
under U.S. Patent Nos. 5,480,484 & 5,679,154.

1
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.
Verify Contents
The package contains:
One Cytofuge®12 Cytocentrifuge (CF12)
One cytocentrifuge rotor (CFRT-12)
One Accesory Carton
The Accesory Carton consists of:
One line cord (for use in North America only).
One Operator’s Manual CD
One latch release tool
3-well Cell Concentrators and 3-well gaskets
pkg of 4, (CC03)
1-well Cell Concentrators and 1-well gaskets
pkg of 4, (CC01)
Stainless Steel Clips for Cell Concentrators
pkg of 8, (CLIP)
Backing Plates for Cell Concentrators
pkg of 4, (BP01)
Filter Concentrators
2 bags of 4 each (FF01)
Stainless Steel Clips for Filter Concentrators
3 pkgs of 4, (FFCL)
Install
oPlace the cytocentrifuge on a solid level surface suitable for operation of laboratory instrumentation.
CAUTION - Do not place the cytocentrifuge on top of other equipment and do not place other
objects or equipment on top of the cytocentrifuge.
oPosition the cytocentrifuge out of direct sunlight and away from sources of intense heat or cold.
Improper conditions can cause damage to the housing, rendering unit unsafe to operate.
oSee the Appendix for the acceptable range of operating temperature and humidity.
oRemove the foam shipping retainer around the rotor before operating the cytocentrifuge.
WARNING - Maintain a 300 mm (11.8 inches) clearance envelope around cytocentrifuge during
operation. Do not deposit any potentially hazardous materials within the CLEARANCE ENVELOPE.

2
Connect Power
oPlug the cytocentrifuge into a grounded outlet supplying 100-240 V @ 50-60 Hz.
oTurn on the power switch (located on the rear panel, above the line cord connector).
oWhen 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. Use a power cord with a
grounded male connector suitable for the power outlet being used, which is rated at 3.0 Amps or
more and has an IEC320/CEE22 female connector to attach to the cytocentrifuge.

3
Section 2
System Overview
Principle and Intended Use
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. Samples are centrifuged in reusable or
disposable gasket-sealed chambers (Cell Concentrators), or in disposable chambers (Filter
Concentrators) that include a filter material to absorb and capture suspension fluid during centrifugation.
A dual row 12-position rotor with transparent lid is supplied as standard equipment. The system is
designed to be operated on a laboratory bench or, if potentially biohazardous samples are processed, in
a biological safety cabinet. A cover interlock system prevents operation until the cytocentrifuge cover is
securely latched, and prevents access to spinning parts until the rotor has come to a complete stop.
Speeds from 200 rpm to 2000 rpm and cycle times from 1 minute to 99 minutes may be selected. The
system features three acceleration rates and dynamic braking to protect delicate samples.
Symbols and Definitions
Product/Reference Number
Indicates the Iris Sample Processing
product/catalog number
Caution
Statement of caution/warning: Read
carefully.
Biohazard
Indicates potential biohazard
EC Representative
European Community Authorized
Representative
For in vitro diagnostic use
Indicates for use only as in-vitro diagnostic
device
Date of manufacture
Indicates instrument manufacturing date
Serial Number
Indicates instrument serial number
Consult Instructions
Refers operator to the instruction manual
for additional information
European Community
Compliance to IVD Directive
Agency
Listed device with Intertek testing agency
Fuse
Rating: (located on serial number label,
replace with same value and type)
AC
Single Phase Alternating Current
IVD

4
Operator Controls
Start
Initiates the selected cycle
Stop/Open
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. Each key press will
change the speed by 10 rpm. Press and hold the key for 2 seconds to change the rpm in 50 rpm
increments.
To change the cycle time use the arrow keys to the right of the TIME display. Each key press will change
the time by 1 minute. Press and hold the key for 2 seconds to change the time in 10 minute increments.
To change the Acceleration rate press the key until the desired rate (high, medium, or low) is illuminated.
To change the Program use the arrow keys to the right of the PROG display.

5
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.
Incorrect Speed
Remove and inspect rotor, check drive
cone o-rings (see Section 5), contact
customer service.
Cover is not closed
Confirm cover is fully seated in closed
position.
Out of balance
Confirm concentrators are balanced in
rotor and cytocentrifuge is on a level
surface.
Accessories
Product No.
Description
CC03
3-well Cell Concentrators and 3-well gaskets; Box of 10
CC01
1-well Cell Concentrators and 1-well gaskets; Box of 10
CLIP
Stainless Steel Clips for all Cell Concentrators; Bag of 10
GK01
Replacement Gasket for CC01 and CCR1; Box of 100
GK03
Replacement Gasket for CC03 and CCR3; Box of 100
CCR1
1-well Cell Concentrators, reusable, autoclavable; Box of 10
CCR3
3-well Cell Concentrators, reusable, autoclavable; Box of 10
BP01
Backing Plates for all Cell Concentrators; Box of 10
FF01
Filter Concentrators , Disposable; Box of 48
FF01-B
Filter Concentrators , Disposable; Box of 200 Filter Cards, 192 Concentrators
FFR1
Filter Concentrators, Reusable; Box of 200 Filter Cards, 20 Concentrators
FFCL
Stainless Steel Clips for Filter Concentrators; Box of 4
CFRT-12
Cytofuge 12 Rotor Assembly, replacement or spare, includes cover
CFRC-12
Cytofuge 12 Rotor Lid, replacement