Helena Laboratories SPIFE 3000 User manual
SPIFE® 3000
Gel Electrophoresis and Processing
Operator's Manual
Catalog Number 1088, 120 Vac
Catalog Number 1089, 240 Vac
SPIFE 3000 Table of Contents
List of Sections
Section 1 - Instrument Use and Function ............................................................................ 1-1
Section 2 - Principles of Operation ...................................................................................... 2-1
Section 3 - Precautions and Limitations ............................................................................. 3-1
Section 4 - Hazards ............................................................................................................... 4-1
Section 5 - Controls and Displays ....................................................................................... 5-1
Section 6 - Installation Instructions ..................................................................................... 6-1
6.1. Unpacking and Inspection ............................................................................................ 6-1
6.2. Installation .................................................................................................................... 6-2
6.2.1. Selecting Instrument Location ................................................................................ 6-2
6.2.2. Removing Shipping Bracket & Leveling Instrument ............................................... 6-2
6.2.3. Connecting Vats & Instrument ................................................................................ 6-2
6.2.4. Power Cord & Parts Handling ................................................................................ 6-3
6.3. Programming for Tests ................................................................................................. 6-4
6.3.1. Electrophoresis Test Programming ........................................................................ 6-4
6.3.2. Stainer Test Programming ..................................................................................... 6-5
6.4. Setup Customizing........................................................................................................ 6-6
6.4.1. Language ............................................................................................................... 6-6
6.4.2. Test List.................................................................................................................. 6-6
6.4.3. Adjust Alarm Volume .............................................................................................. 6-7
6.4.4. Key Beep................................................................................................................ 6-7
6.4.5. Positive Patient ID .................................................................................................. 6-7
6.4.6. Reagent Detection ................................................................................................. 6-8
6.4.7. Purge Time ............................................................................................................. 6-8
6.4.8. Return to Main Program ......................................................................................... 6-8
Section 7 - Operating Instructions ....................................................................................... 7-1
7.1. Preparation ................................................................................................................... 7-1
7.1.1. CAUTIONS ............................................................................................................. 7-1
7.1.2. Powering Up Instrument ......................................................................................... 7-1
7.2. Positive Patient ID ........................................................................................................ 7-1
7.3. Instrument Operation .................................................................................................... 7-2
7.3.1. Kit Supplied Procedures ......................................................................................... 7-2
7.3.2. TEST SELECT/CONTINUE Keys .......................................................................... 7-2
7.3.3. START/STOP Keys ................................................................................................ 7-2
7.3.4. Instrument Alarm .................................................................................................... 7-2
7.3.5. Start Test at Any Operation .................................................................................... 7-2
7.3.6. To Abort Operation ................................................................................................. 7-2
7.3.7. Electrophoresis Specific Information ...................................................................... 7-3
7.3.8. Stainer Specific Information ................................................................................... 7-3
7.4. Results .......................................................................................................................... 7-3
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SPIFE 3000 Table of Contents
7.5. Cleanup ........................................................................................................................ 7-3
Section 8 - Test Functions and Quality Control.................................................................. 8-1
Section 9 - Performance Specifications .............................................................................. 9-1
Section 10 - Maintenance, Troubleshooting, Warranty .................................................... 10-1
10.1. Maintenance ............................................................................................................. 10-1
10.1.1. Clean Electrophoresis Chamber ........................................................................ 10-1
10.1.2. Clean Electrodes ................................................................................................ 10-1
10.1.3. Clean Rigid Antisera Template ........................................................................... 10-1
10.1.4. Clean Sample Base (Non-Disposable Type) ...................................................... 10-1
10.1.5. Perform Maintenance Wash ............................................................................... 10-1
10.1.6. Clean Stainer Level Detectors ............................................................................ 10-2
10.1.7. Clean the Waste Level Sensor ........................................................................... 10-2
10.1.8. Fuse Replacement ............................................................................................. 10-2
10.1.9. Replacing Contact Sheet (Electrophoresis Chamber Insulation) ........................ 10-2
10.1.10. Clean Gel Holder .............................................................................................. 10-3
10.1.11. Clean Antisera Tray ......................................................................................... 10-4
10.1.12. Clean Instrument .............................................................................................. 10-4
10.1.13. Rinse/Replace Reagent Vat(s) ......................................................................... 10-4
10.2. Troubleshooting ........................................................................................................ 10-6
10.3. Warranty ................................................................................................................... 10-8
Section 11 - Symbology ...................................................................................................... 11-1
List of Figures
Figure 1-1 SPIFE 3000 .......................................................................................................... 1-2
Figure 2-1. Signal Flow Diagram, Electrophoresis Side ................................................... 2-3
Figure 2-2. Signal Flow Diagram, Stainer Side .................................................................. 2-4
Figure 5-1 SPIFE 3000 Controls and Displays ................................................................... 5-2
Figure 5-2 Power On/Off Switch, Right Side ...................................................................... 5-2
Figure 5-3 SPIFE 3000 Menus ............................................................................................. 5-3
Figure 6-1 Shipping Bracket Installed ................................................................................ 6-9
Figure 6-2 Shipping Bracket Removed ............................................................................... 6-9
Figure 6-3 SPIFE 3000 Installation .................................................................................... 6-10
Figure 6-4 Ports and Tubing, Left Side ............................................................................. 6-11
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SPIFE 3000 Table of Contents
Figure 6-5 Connection for Barcode Reader, Power Cord, Catch Pan Port, and
Overflow Sensor (or Shorting Plug), Back ........................................................................ 6-12
Figure 7-1 Blades in Applicator, Gel in Chamber .............................................................. 7-4
Figure 7-2 Placement of Sample Tray with Disposable Cups .......................................... 7-5
Figure 7-3 Gel and Gel Holder Above Stainer Chamber ................................................... 7-6
Figure 10-1 Fuses ............................................................................................................... 10-5
List of Tables
Table 6-1 Inventory ............................................................................................................... 6-1
Table 10-1 Maintenance Schedule Summary .................................................................... 10-1
Table 10-2 Troubleshooting .............................................................................................. 10-6
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SPIFE 3000 ONE - Instrument Use and Function
Section 1 - Instrument Use and
Function
Helena Laboratories’ SPIFE 3000 (Figure
1-1) is used for automatic sample application, electrophoresis, automatic reagent
application and spreading, staining, fixing,
destaining, and drying of SPIFE agarose
gels. It will completely process the gel for
viewing or for quantitation of results on a
densitometer. SPIFE 3000 is to be used
only with Helena Laboratories SPIFE gels.
SPIFE 3000 is intended for in-vitro diagnostic use only, and is for use in a
laboratory or similar environment.
SPIFE 3000 contains preprogrammed parameters for SPIFE Serum Protein, Serum
or Urine IFE, CSF IgG IEF, Acid Hemoglobin, Alkaline Hemoglobin, Alkaline
Phosphatase, Cholesterol Profile, LD Isoenzyme, CK, Split Beta SPE, and
Lipoproteins tests (for electrophoresis and
staining) and QuickGel Acid Hemoglobin,
Split Beta SPE, CK, LD Isoenzyme, and
Alkaline Hemoglobin (for staining). You
may alter the parameters for these tests, if
desired. Additional tests will become
available in the future and you will be able
to program the SPIFE 3000 with those parameters.
Refer to the procedure supplied with the
reagents for information on the following
areas:
Summary
Principle
Reagents
Instruments
Specimen Collection and Handling
Reagent Preparation
Sample Application
Test Procedure
Performance Characteristics
Stability of End Product
Reference Values
Evaluation of the Bands
Interpretation of Results
Bibliography
The SPIFE 3000 automates or eliminates
the technique-dependent steps of conventional electrophoresis. Samples are
automatically applied to the gel, then electrophoresed. When appropriate, reagents
are automatically spread on the gel and
incubated.
Gels are moved to a gel holder and lowered into the staining chamber, where they
are washed, stained, destained, fixed, and
dried automatically. The processed gels
can then be scanned with a densitometer
and the results printed on a report form.
1-1
SPIFE 3000 ONE - Instrument Use and Function
Figure 1-1 SPIFE 3000
1-2
SPIFE 3000 TWO - Principles of Operation
Section 2 - Principles of Operation
The relationship of the functional units of
the SPIFE 3000 are shown in Figure 1-1
and Figure 2-1. SPIFE 3000 is divided
into two distinct parts, the applicator/incubation and electrophoresis side on
the right, and the stainer side on the left.
Operation is controlled by a microprocessor and its memory, and by four push
keys.
The applicator consists of a rack which
holds disposable blade applicators, a motor to move the blades to the sample and
to the gel, a reagent dump bar, and a motor to move the bar. The electrophoresis
side contains a power supply, electrodes,
constant voltage output for electrophoresis, and electrophoresis chamber heating
and cooling systems. The stainer side
contains a heater/dryer blower, a gel
chamber, gel carrier switch, fluid level detectors, temperature sensor, fluid valve,
and fluid pump.
The microprocessor directs operation of
the LCD display and the push keys let the
operator respond to the displays. During a
typical operation, the operator loads sample, selects the type of test, and can start
or stop the automatic sequence of operations using the appropriate push keys.
Any time a prompt appears which requires
a user action, an alarm will sound until the
user presses the indicated key.
Sample is manually loaded into sample
wells and the operator positions the wells
and the gel. The applicator then automatically picks up sample and applies it to the
gel.
For electrophoresis and incubation, the
gel is manually placed in the electrophoresis chamber. The electrodes are
positioned, the door is closed and the
right-hand TEST SELECT/ CONTINUE
key is pressed to select a test, and
START/STOP is pressed to start the selected test. Electrophoresis takes place at
the programmed parameters when high
voltage is applied across the electrodes
and gel. If required by the test, incubation
and pre-drying are accomplished by controlling and monitoring the temperature of
the electrophoresis chamber.
If required by the test, the reagent is automatically applied and spread.
When prompted, the operator removes the
electrodes, then the gel blocks. The electrodes are then replaced and the righthand TEST SELECT/CONTINUE key is
pressed to dry the plate. The gel is then
placed in the stainer chamber.
When the left-hand START/STOP key is
pushed, the microcomputer directs the fluid valve to open one of the fluid lines and
turns on the fluid pump to fill the stainer
chamber with the appropriate solution. A
level detector signals the microcomputer
when to stop the filling operation, and the
pump is turned off. The operation is
timed. When the time reaches zero, the
microcomputer directs the fluid valve to
open another line and turns the pump on
again. The pump empties the solution
through a fluid drain.
This sequence of events is repeated for
each necessary solution in the staining,
fixing, and destaining procedures. If agitation is required, the fluid pump moves
solution in and out of the stainer chamber.
The microcomputer then signals the heaters in the staining chamber to heat the
chamber to drying temperature. An air fan
blows heated air through the chamber.
Temperature is controlled by a sensor.
When drying time reaches zero, the microcomputer turns off the heaters and an
alarm notifies the operator that the procedure is complete.
2-1
SPIFE 3000 Table of Contents
The computer initializes at power on and
runs a self-test to detect error conditions
or potential problems. If an error is detected, the computer responds by
displaying an error message (see section
10.2, Troubleshooting).
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SPIFE 3000 TWO - Principles of Operation
Memory
Push Keys
Lid Switch
Voltage / Current
Monitor
Chamber TEC
Current Monitor
Electrophesis Display
Audio Alarm
Electrophoresis Power
Supply
Microcomputer
Chamber TEC
Controller
Chamber Temperature
Monitor
Figure 2-1 Signal Flow Diagram, Electrophoresis Side
Fans
Applicator
2-3
SPIFE 3000 TWO - Principles of Operation
Memory
Pushbuttons
Temperature Sensor
Fluid Level Sensors
Gel Holder Sensor
Stainer Display
Beeper
Heater
Microcomputer
Blower
Pumps
Valve Position Controls
Figure 2-2 Signal Flow Diagram, Stainer Side
2-4
SPIFE 3000 THREE - Precautions and Limitations
Section 3 - Precautions and
Limitations
3.1. The entire operator’s manual should
be read and understood before attempting
instrument operation.
3.2. Refer to the procedure supplied with
the gels and reagents for proper gel orientation, reagent preparation, specimen
collection and handling, and other information.
3.3. Use only reagents and gels made
specifically for use with SPIFE instruments. Refer to the procedures supplied
with the reagents for precautions and limitations specific to the reagents.
3.4. Do not expose the instrument to
drafts or to direct sunlight. Do not operate
at temperatures above 80°F (27°C) or below 59°F (15°C), or allow prolonged
exposure to high humidity.
3.5. Do not place the instrument near a
strong source of electromagnetic interference, such as a centrifuge, x-ray machine,
etc.
3.6. Provide adequate room on all sides
of the instrument for good air circulation.
3.7. Do not block air vents or intakes.
3.8. To prevent damage to the SPIFE
3000, never place objects on the top of
the instrument. Keep the gel holder installed in the stainer at all times.
3.9. This instrument should not be connected to any other devices or instruments
in any way not described in this manual.
3.10. Do not expose the sample tray to
temperatures above 158°F (70°C), or severe warping of the tray may result,
making the tray unsuitable for use.
3.11. Installation should not be attempted
unless a representative of Helena Laboratories or of its subsidiaries or distributors is
present, or, unless verbal or written permission to proceed has been given by
Helena Laboratories, its subsidiaries or
distributors.
3.12. The instrument should not be moved
once the Helena Laboratories approved
representative has installed the instrument. For ALL moves, the instrument’s
shipping bracket, used to lock the applicator sled in place, must be installed.
Improper handling of the applicator sled
could result in the instrument needing realignment, which can only be completed by
a Helena Laboratories representative.
3.13. This instrument meets the leakage
current specifications of directive EN
61010-1. To meet standards more stringent than this, we recommend either
grounding the instrument to station ground
via the ground lug provided on the back of
the instrument, or the purchase of an isolation transformer. Specifications for this
transformer are given in section nine.
3.14. For emergency shut down, disconnect the SPIFE 3000 power cord.
3.15. All tubing must be securely connected to fittings to prevent leaks.
3.16. Before starting electrophoresis verify
the following. The sample gels are oriented correctly. The sample cups are
installed correctly and are fully seated in
the sample tray. The applicator blades
are properly seated and installed in the
slots indicated in the procedure supplied
with the reagents. The reagent bottle is
installed correctly and fully seated in the
dump bar, if applicable.
3.17. Due to high heat, do not touch the
surfaces of the electrophoresis chamber
immediately after pre-drying.
3.18. Should an instrument be contaminated by blood or blood derivative, spray
any contaminated surface with a commercial virucidal and germicidal agent.
Observe where the specimens are used
inside the instrument and confine cleaning
to that area. Wipe up the residue. These
3-1
SPIFE 3000 TWO - Principles of Operation
materials contain corrosives and are
harmful to metal surfaces.
No harsh cleansers, acids, or bases
should be used or spilled on inner or outer
surfaces. Do not immerse the unit. AL-
WAYS UNPLUG THE MAIN POWER
CORD BEFORE CLEANING.
3-2
SPIFE 3000 FOUR - Hazards
Section 4 - Hazards
4.1. If the instrument is used in a manner
not specified by this manual, the protection provided by equipment design may be
impaired.
4.2. This device contains very high voltages which can be extremely dangerous.
Safeguards are built into the instrument to
prevent user contact with high voltage;
however, ALWAYS TURN OFF THE
POWER, DISCONNECT THE MAIN
POWER CORDS, AND USE EXTREME
CARE when attempting disassembly for
cleaning, repair, or adjustments.
4.3. Shock hazard. Never touch the
cables at the rear of the SPIFE 3000
during operation. When the electrophoresis chamber lid is open, power to
the chamber is cut off. However, never
touch the electrophoresis chamber during electrophoresis.
4.9. Follow safe handling and disposal
procedures for reagents used with this instrument.
4.10. Keep flammable liquids and flammable vapors away from the instrument at all
times.
4.4. Do not attempt to operate the instrument without plugging the power cords
into a grounded wall outlet of the proper
voltage and frequency. This information is
contained on the serial number plate located on the back of the instrument.
4.5. Do not operate with the cover re-
moved. Do not place fingers under the
applicators.
4.6. Do not lubricate any parts of the instrument not specified by Helena
Laboratories.
4.7. Do not touch the gel chamber anywhere except where directed by the
labeling. The inner surfaces of the gel
chamber reach temperatures of 60° to
70°C and can cause burns.
4.8. Use only the reagents specified by
the Helena procedure in use. Damage to
the instrument may result from introducing
some types of solutions into the instrument.
4-1
SPIFE 3000 FIVE - Controls and Displays
Section 5 - Controls and Displays
1. Main Power Switch: A switch on right
side of SPIFE 3000 which controls power
to the instrument (Figure 5-2).
2. Displays: Two liquid crystal displays
are provided, one for the electrophoresis
chamber and one for the staining chamber. Each is 2-lines with 40 characters per
line. The displays show test type, prompts
and status, or messages throughout operation (Figure 5-1).
The displays for the electrophoresis and
stainer sides shown on Figure 5-3, all appear for test programming (EDIT mode);
however, only the selected displays appear when performing a test or while
viewing a test’s programming (READ
mode). A display’s first line is the prompt
to the user and the second line is the instrument operation.
Electrophoresis Chamber
3. START/STOP Key: Starts or stops op-
eration of electrophoresis chamber (Figure
5-1).
4. TEST SELECT/CONTINUE Key: Selects test type and is used as a means of
operator response to displayed prompts
(Figure 5-1).
The START/STOP and TEST SELECT/
CONTINUE keys are also used while programming test parameters.
Stainer Chamber
5. START/STOP Key: Starts or stops op-
eration of staining chamber (Figure 5-1).
6. TEST SELECT/CONTINUE Key: Se-
lects test type and is used as a means of
operator response to displayed prompts
(Figure 5-1).
The START/STOP and TEST SELECT/
CONTINUE keys are also used while programming test parameters.
5-1
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