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2 Primary Tube Centrifuge
Operator’s Manual
Operator’s Manual
Express 2 Primary Tube Centrifuge
Model Number M501-22
FOR IN VITRO DIAGNOSTIC USE
Product Number
SSX2 - Express 2 for 100-240 VAC, 50/60 Hz
StatSpin is a registered trademark of StatSpin Inc., a Subsidiary of IRIS International, Inc.
Copyright 2001, 2003
Printed in U.S.A.
Table of Contents
i
How to use this manual.............................................................................................ii
Section 1..............................................................................................................1
Unpacking and Installation.......................................................................................1
Inspect Packaging.................................................................................................1
Verify Contents......................................................................................................1
Install System ........................................................................................................1
Connect Power......................................................................................................1
Section 2 ……………………………………………………………..……….……….. 2
System Overview ……………………………………………………………………...2
Principle and Intended Use
Symbols and Definitions …………………………………………………………………………….. 2
Error Indicators ……………………………………………………………………………………………3
Accessories………………………………………………………………………………………………....3
Section 3 ………………………………………………………………………………..4
Operating Instructions ……………………………………………………………… 4
Opening and Closing the Cover …………………………………………………………….. …. 4
Removing and Installing the Rotor ……………………………………………………………. 4
Spinning the Sample ………………………………………………………………………………… 5
Section 4 ………………………………………………………………………………. 6
Maintenance ….……...…………………………………………………………..…….6
Overview ……………………………………………………………………………………………….... 6
Cleaning …………………………………………………………………………………………….………6
Checking the Rotor Speed……………………………………………………………………………7
Service ………………………………………………………..……………………………..……..………….7
Troubleshooting .................................................................................................... 8
Appendix .............................................................................................................9
Appendix A - Specifications .................................................................................9
References………………………...…………………………………………..…………….. 10
StatSpin Warranty……
.………………………………………………………………11
………………………………………………………………...……… 2
i
This manual along with inf ormation cont ained on product labels and in package ins erts should
provide you with all the information you need to operate and maintain the Expr ess 2.
Notes appear in italics to highlight information. When the information requires special attention, a
caution symbol appears next t o the italicized text.
Please pay close attention to the instructions that acc ompany the notes and symbols as well as the
standard laboratory practic es outlined by your f acility and local regulatory agencies. The table below
lists all the CAUTIONS/WARNINGS for the Express 2.
WARNING - North American Installation: Only use the power supply included
with the unit. Use of other power supplies or transformers will damage the Express
2 electronics and void the warranty.
WARNING - Outside of North America: Do Not Use the Line Cord Supplied. Use
power cord for at least 1.0 Amp or more with an IEC320/CEE22 female c onnector
and male connector suitable for the power outlet to be used.
CAUTION - The cover interlock bypass is designed for emergency use only. If the
equipment is not used properly, safety may be impaired.
CAUTION- The rotor (RTX4) has a finite lifespan that is dependant on usage.
Cracks or swelling that develop indicate the rotor should be replaced immediately.
CAUTION – Failure to properly install the rotor may result in damage to the
centrifuge and will void the warranty.
CAUTION – Never operate the Express 2 without the rotor in place.
CAUTION - Replace balance tube every 10 cycles to prevent possible breakage
due to the repeated stress of centrifugation.
CAUTION
maintenance.
WARNING – Do not expos e Express 2 and its rotor to strong or concentrated acids,
bases, esters, aromatic or halogenated hydrocarbons, ketones or strong oxidizing
agents.
CAUTION – DO NOT spray the bowl or outer surfaces wit h detergent or bleach.
Excess liquid will harm the electronics and subsequent problems may not be
covered under warranty.
CAUTION - Universal Precautions should be followed on all spec imens, regardless
of whether a specimen is known to contain an infectious agent. (See references)
How to use this manual
– Unplug the Express 2 from the wall outlet before performing
Please use the system as intended. Improper use of the Express 2 Primary Tube Centrifuge and/or
its ac c essori es may c ause damage t o t he syst em, inacc urate results, or potentially nullif y w ar ranti es.
The Express 2 Primary Tube Centr ifuge, and its ass ociated components are covered under US
patent nos. 4,846,974 & 4,981,585 & 5,566,919
ii
Section 1
Unpacking and Installation
Inspect Packaging
The Express 2 and its acc essories are delivered in one carton. If the centrifuge or acc essories have
suffered any damage in transport, please inform your carrier immediately.
NOTE: Save shipping carton and components to simplify return should service be required.
Verify Contents
The package cont ains:
One Express 2 centr ifuge (Model No. M501-22)
One Centrifuge Rotor (Product No. RTX4)
Four Rotor Inserts for 13x75 mm tubes (Product No. SV01)
One Universal Switching Power Supply
(StatSpin Product No. 01-3553- 001, APS Product No. AD-740U-1240)
One grounded line cord (f or North American use only)
One Operator’s Manual
One Tool for Removing Rot or, 7/16” Nut Driver
Install System
1. Place the Express 2 on a level surface suitable for laboratory instrumentation.
2. Maintain a 300mm clearance boundary around the centrifuge for ventilation and safety.
3. Position the Express 2 away from direct sunlight and sources of heat or cold.
(See Appendix A for specifications.)
4. Remove blue foam packaging around the rotor befor e oper ating the centrifuge.
Connect Power
Plug the power supply into a grounded outlet supplying the voltage and frequency indicated on the
power supply. When power is connected, the 30 s. LED will illuminate and the cover lock will
release.
WARNING - North American Installation:
Use of other power supplies or transformers will damage the Express 2 electronics and void
the warranty.
WARNING - Outside of North America: Do Not Use the Line Cord Supplied. Use power
cord for at least 1.0 Amp or more with an IEC320/CEE22 female connector and male
connector suitable for the power outlet to be used.
Only use the power supply included with the unit.
1
Principle and Intended Use
IVD
For in vitro diagnostic use for rapid separation of whole blood contained in original collection tubes.
The Express 2 is a microprocessor controlled, high-speed bench top centrifuge designed to rapidly
separate blood in the original evacuated or syringe type collection tubes.
The four-place 30° angle rotor included with the centrifuge is designed to provide rapid s eparation
while minimizing potent ial re-suspension of cells. The speed is fixed at 8500 r pm (+
producing a centrifugal force of 4440 xg at the maximum tube radius of 5.5 cm. The operator may
select three factory-set timed cycles, each cycle spinning for 30, 120 and 180 seconds.
Symbols and Definitions
Section 2
System Overview
250 rpm),
Start button The start button initiates a pre-timed cycle at the
speed select ed. NOTE: The Ex press 2 does not have
an on/off switch and is normally left plugged in and
“on”.
Stop/open button The stop/open button interrupts the cycle and stops
Cycle selector This button allows for selection of the appropriate
Error/Service
indicator
Power input DC Power Input: 24V DC Plug-in
the centr ifugation. This button may also be used to
release the cover.
cycle.
The red LED identified, as error/service is illuminated
continuously or flashing when s ervice is r equired.
2
Symbols and Definitions (cont.)
REF
Product/Referenc e
Number
Caution Statement of caution/warning, read instruction
Temperature
limitation
Indicates the StatSpin pr oduct/catalog number
carefully
Indicates storage requirements range
Error/Service
light flashing
or continous
Error Indicators
Error codes for t he Express 2 ar e s pecified by a combin ation of the Error/Service LED flashing or
continuous and any combination of the cycle LEDs on the front panel.
Error/Service = Quick Spin = 30 s Normal Spin = 120 s Hard Spin = 180 s
IVD
S N
EC Representat ive European Community Author ized Representative
For in vitro
diagnostic use
Non sterile Indicates non-sterile pr oduct
Serial Number Indicates instrument serial number code
Consult
Instructions
Rotor failed
to reach rpm
within 30 s
Clarifies for us e as in vitro diagnostic only
Consult instruction manual or insert sheet for further
explanation
Cover opened
or cycle
changed during
operation
Insufficient
power to
maintain
rpm
Rotor spun
backward
direction during
reverse braking
Error/Service light will continuously illuminate when the c entrifuge has achieved a total cycle count of 18,000, which
is the us eful life of t he drive system. Drive mechanism needs r eplacing. Contact an aut horized service center.
Accessories
Product No. Description
SV01 Inserts for 5 mL tubes (13 x 75 mm or 10.25 x 82 mm) 4/pk. Included with centrifuge
SV02 Inserts for 3 mL tubes. (10.25 x 64 mm) 4/pk.
SV03 Inserts for 2 mL tubes. (10.25 x 47 mm or BD Microtainers) 4/pk.
SV04 Inserts for 1.5-2 mL Microtubes (e.g. LipoClear) 4/pk.
DL01 Disposable chamber liners. 10/pk.
RTX4 Express 2 Rotor. Includes four SV01 inserts.
3
Operating Instructions
Opening and Closing the Cover
The system’s electr ically operated c over interlock mechanism prevents operation until the cover is
completely c losed and latched, and prevents the cover from being opened while the rotor is turning.
When the cover is c ompletely closed and locked an oper ating cycle can be initiated.
The system is also equipped with a manually operated latch that holds the cover down after spinning
is complete. The int erlock is automatically released at the end of the operating cyc le or by pushing
the stop/open button. Squeeze the black latch pieces together to open cover.
Cover Interlock By-pass
The electronically operated c over interlock mechanism can be released manually by ins erting the
straightened end of a large paper clip or similar object into the small hole in the center of the front
membrane panel. Manually push the lock lever inward about one inch (25mm) to releas e the
interlock mechanism if the stop/open button does not release the cover.
CAUTION - The cover interlock bypass is designed for emergency use only. If the
equipment is not used properly, safety may be compromised.
Section 3
Removing and Installing the Rotor
The Express 2 is shipped with the rot or installed. To prevent possible damage to the centrifuge’s
motor mount, it is important t o remove the rotor whenever the centrifuge is moved or shipped to
another location.
CAUTION- The rotor (RTX4) has a finite lifespan that is dependant on usage. Cracks
or swelling are signs of fatigue, replace immediately.
1. Remove the tube inserts from the rotor.
2. Remove r otor, locking nut and washer fr om the rotor holder using 7/16” nut driver.
3. Gently rock the rotor back and forth until the mounting pins on the rotor holder release.
4. Remove the rotor.
To re-install rotor:
1. Remove the tube inserts from rotor. Place rotor on rotor holder, ens uring the two mounting pins
on the rotor holder are aligned with two of the four s mall holes near t he center of the rotor.
2. Gently rock the rotor back and forth to ensure the rotor seats properly on the rotor holder.
3. Install washer, then nut and secure the rotor by tight ening the nut with the 7/16” nut driver
provided.
4. Re-install the tube inserts into the rotor cavities. The centrifuge is now ready for use.
CAUTION- Failure to properly install the rotor may result in damage to the centrifuge
and will void the warranty.
4
Spinning the Sample
Loading
CAUTION - Never operate the Express 2 without the rotor in pl ace.
1. Ensure the appropriate tube inserts are inst alled. The Express 2 centrifuge is
provided with four tube inserts for 13 x 75 mm tubes (Product No. SV01). Other sizes
are avail able (See accessories).
2. Two or four tubes may be processed at one t ime. The rotor must be properly
balanced to ensure smooth oper ation.
3. Use the same size and style tubes in opposite positions. Balance liquid in tubes to
within 0.5 mL.
CAUTION - Replace balance tube every 10 cycles to prevent possible breakage due
to repeated stress of centrifugation.
4. Clos e and latch the centrifuge cover.
5. Select the appropriat e cycle by pressing the cycle selector until the desired LED is
illuminated. (See Table 1)
6. Press start button.
Table 1: Express 2 Cycle Settings. The operator should experiment with different settings to
achieve optimum performance for specific applications. The following are general guidelines:
Setting Speed Time
30s Intended t o provide a short spin
to immediately separate the red cells
from the plasma/serum.
120s Intended t o produce good
quali ty plas m a/seru m fr om w hole
blood for chemistry or coagulation.
180s Intended to provide a minimal
particle/cell count and should be
used for specialized applications.
(e.g Lipoclear
The normal spin (120 s) can be used for most chemistry and coagulation applications.
The hard spin (180 s) can be used for gel separator tubes. (PST/SST)
NOTE: The Expr ess 2 has no “on-off” switch, and therefore is normally left plugged in and “on”.
Unloading
®
)
8500 rpm 30 seconds
8500 rpm 120 seconds
8500 rpm 180 seconds
1. Upon completion of the cycle, the rotor decelerates to a c omplete stop in 25 seconds and
the latch interlock automatically unlocks.
2. Squeeze the black latch pieces together to open cover.
3. Carefully remove tubes using care not t o re-suspend the sediment.
5
Overview
StatSpin recommends that instrument operators perform per iodic inspections and preventative
maintenance on all StatSpin instruments. Contact StatSpin’s cust omer service department or
distributor if, at any time, the instrument is not functioning properly.
Cleaning
The Express 2 is supplied with a disposable bowl liner to simplify routine cleaning. Additional bowl
liners are available. (Pr oduct No. DL01). The liner should be replaced monthly or whenever a spill
occurs. Clean the outside surfaces and switch overlay panel with a water-dampened cloth and mild
detergent. Clean the inner surf ace or bowl with a mild detergent, and if necess ary, a disinfect ant,
wiping s urf ac es with a
Section 4
Maintenance
CAUTION - Unplug the Express 2 from the wall outlet before performing
maintenance.
WARNING - Do not expose Express 2 and its rotor to strong or concentrated acids,
bases, esters, aromatic or halogenated hydrocarbons, ketones or strong oxidizing
agents.
dampened cloth using 70% alcohol or 10% bleach solut ion.
General Cleaning
Rotor Disinfecting
CAUTION - DO NOT s pray the bowl or outer surfaces with detergent or bleach.
Excess liquid will harm the electronics and subsequent problems may not be covered
under warranty.
1. Open centrifuge cover.
2. Unplug the power supply from the electrical outlet.
3. Remove all tubes and ins erts. Remove the rotor (see Removing and Installing the Rotor).
4. Remove the black gasket surrounding the chamber by pulling up one end of the gasket.
5. Remove the bowl liner and dispose. Install a new bowl liner.
6. Replace the black gasket around the chamber opening.
7. Reinstall rotor (see Removing and Installing the Rotor).
8. Plug in the power supply.
1. Open centrifuge cover.
2. Unplug the power supply from the electrical outlet.
3. Remove all tubes and ins erts. Remove the rotor (see Removing and Installing the Rotor).
4. The rotor and inserts may be soaked in detergent and warm water or a 10% bleach solution.
5. DO NOT attempt to clean an insert that has a broken tube. Dispos e of insert immediately.
6. Dry the rotor and inserts with a clean absorbent paper towel or allow to air dry.
7. Re-install the rotor (see Removing and Installing the Rotor).
6
Checking the Rotor Speed
The rated speeds (+5%) can be checked with a photoelectr ic tachometer availabl e from many
sources. If the Expr ess 2 fails to achieve operating speed 8500 rpm
StatSpin Cus tomer S er vice depart ment.
Service
There are no us er-serviceable parts. Refer all service to qualified service personnel.
Reference the StatSpin W arranty for further instruction. Be sure to complet e and return t he warranty
card as directed.
Decontamination before returning for service
Any instrument or access ory containing accumulated blood and/or other biological or chemical
deposits must be cleaned prior to shipment to the manuf acturer/dealer for servic e. This
decontamination is required by Feder al Law (Title 48 and 49 of the Feder al Regulations) and in
accordance with the Environmental Protection Agency’s Regulat ions for Biohazard W aste
Management. StatSpin personnel cannot perform this decontamination.
+5% contact your distributor or
7
Troubleshooting
No Power Light
↓
Is the power cord completely
plugged into the wall?
↓
YES
↓
Is the wall outlet working properly?
↓
Is the barrel connector from the
transformer completely plugged into
the centrifuge?
↓
YES
↓
Contact StatSpin or an Authorized
Repair Facility.
Centrifuge Will Not Spin/Shuts
Off Prematurely
↓
Is the cover completely c losed and
cannot be opened manually?
↓
YES
↓
Contact StatSpin or an Authorized
Repair Facility.
→ NO→
→ NO→
→ NO→
→ NO→
Plug power cord into the wall.
Try another wall out let.
Plug the barrel connector into the centrifuge.
Completely close the cover.
Centrifuge will not open at end
of cycle
↓
Is the bowl gasket completely
seated and sealing the bowl?
↓
YES
↓
Contact StatSpin or an Authorized
Repair Facility.
→ NO→
Press the bowl gasket all the way down into
the housing slot.
8
Appendix A - Specifications
Product No. SSX2
Model No. M501-22
Speeds 8500 rpm + 250
Force 4440 xg
Cycles 30s: 30 seconds
120s: 120 seconds
180s: 180 seconds
Acceleration Time Approximately 20 seconds
Deceleration Time Approximately 25 seconds
Electrical 24 Volts, DC, 1.7 amp. Includes switching power supply for 100-240
Dimensions Diameter 6.6”/ 16.8 cm
Height 6.0”/15.2 cm
Weight 5 lbs/2.3 kg
Environmental Indoor use
Altitude up to 2000m
Temperature 5ºC to 40ºC
Maximum relative humidity 80% for temperatures up to 31ºC decreasing
Main supply voltage fluctuations not to exceed +/- 10% of the nominal
Transient over-voltages according to installation category II
Pollution degree 2
Appendix
VAC, 50/60 Hz
linearly to 50% relative humidity at 40ºC
voltage
9
A Subsidiary of IRIS International Inc
Norwood, MA 02062 USA
Phone: 800-782-8774
or 781-551-0100
Fax: 781-551-0036
www.statspin.com
mdi Europa GmbH
Wittekamp 30
D-30163 Hanover Germany
+49-511-39089530
Made in USA
References
1. NCCLS. “Protection of Laboratory Workers from Occupationally Acquired Infections;
Approved Guideline-Second Edition.” NCCLS document M29-A2 [ISBN 1-56238-453-8].
NCCLS, 940 West Valley Rd, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2001.
2. CDC. Recommendations for prevention of HIV transmission in health care settings.
MMWR (Suppl. No. 2S):2S-18S, 1987.
3. CDC. Updated: US Public Health Service Guidelines for the Management of Occupational
Exposures to HBV, HCV and HIV and Recommendations for Post Exposure Prophylaxis.
Appendix A and B. MMWR 50 (RR-11): 1-42, June 29, 2001.
55-003910-001 Rev. E
10
StatSpin Warranty
StatSpin, Inc., a Subsidiary of IRIS International, Inc. warrants that the instruments shall be free from defects in
material and/or workmans hip, under normal use and s ervice, for the period expiring twelve (12) months from the
date of installation, provided the purchaser has completed and forwarded to StatSpin the Warranty Registration
Card. StatSpin will, at its discretion repair or replace any unit covered under this warranty returned to StatSpin
with shipping costs prepaid. Repaired or replaced instruments supplied under this warranty c arry only the
remaining portion of the original warranty and repairs shall not interrupt or prolong this warranty. For warrant y
terms and conditions outside the United States, c ontact your Authorized StatSpin Distributor.
No warranty extended by StatSpin shall apply to any instrument that has been damaged due to misuse,
negligence, accident, or damage resulting from unauthorized repairs, alterations, or improper installation.
StatSpin mak es no warrant y other than the one set forth herein. This warranty is given expressly in lieu of all other
warranties, express ed or implied. The purchaser agrees that there is no warranty of merchantability or of fitness
for any intended purpose and that there are no other remedies or warranties, express ed or implied, which extend
beyond the description on the face of the agr eement. No agent or employee of StatSpin is authorized to extend
any other warranty or assume for StatSpin any liability except as set forth above. This warranty is only applicable
to the original purchaser.
Limitation of Liability
StatSpin shall not be liable for any loss of use, revenue or anticipated profits, or for any consequent ial or incident al
damages resulting from the sale or us e of the products. The purchaser shall be deemed liable for any and all
claims, losses, or damages incurred by the us e or misus e of the StatSpin instrument by the purchaser, its
employees or others, following receipt of the instrument or other items.
11
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