Cytology Centrifuge - Separation Technology Inc.

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