IRIS M510 User manual

StatSpin®Express 4 Horizontal Centrifuge
Operator’s Manual
A Division of IRIS International, Inc.

Operator’s Manual
StatSpin®Express 4
Horizontal Centrifuge
Model Number M510
For in-vitro diagnostic use
Product Number
SSH4 –StatSpin®Express 4 for 100-240 VAC, 50/60 Hz
StatSpin and Iris are registered trademarks of IRIS International, Inc.
Copyright 2008
Printed in U.S.A.

i
Table of Contents
How to use this manual…………………………………………..……….………… ii
Section 1 ……………………………………………………………..……….……….. 1
Unpacking and Installation ..………………………………………………………...1
Inspect Packaging ………………………………………………………………...………................... 1
Verify Contents ………………………………………………………………...………. ........................ 1
Install ………………………………………………………………...………. ............................................ 1
Connect Power ………………………………………………………………...………. ........................ 1
Section 2 ……………………………………………………………..……….……….. 2
System Overview ……………………………………………………………………. .2
Principle and Intended Use ………………………………………………………………...……… 2
Symbols and Definitions ………………………………………………………... 2
Operator Controls ………………………………………………………………...……….................... 3
Error Indicators …………………………………………………………………… 3
Error Codes Table…………………………………………………………...........4
Accessories………………………………………………………………………... 4
StatSpin Express 4 Tube Insert Guide………………………………………… 5
Section 3 ……………………………………………………………………………….. 6
Operating Instructions ……………………………………………………………… 6
Opening and Closing the Cover ………………………………………………………………… 6
Removing and Installing the Rotor ……………………………………………………………… 6
Spinning the Sample …………………………………………………………………………………. 7
Section 4 ………………………………………………………………………………..8
Maintenance ….……...…………………………………………………………..……. 8
Overview ………………………………………………………………………………………………..… ... 8
Cleaning …………………………………………………………………………………………….…….... 8
Checking the Rotor Speed………………………………………………………………….…… ..... 8
Troubleshooting …………………………………………………………………………………….…… 9
Service ………………………………………………………………………………….…… ....................10
Section 5 …………………………………………………………………………… .. 11
Appendix …..….……...…………………………………………………………..… ..11
Specifications………………………………………………………………………………………….… 11
References………………………………………………………………………………………………. 12
Warranty………………………………………………………………………………….… ...................13

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 StatSpin®Express 4.
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 StatSpin®Express 4.
WARNING –Do not expose the centrifuge or its rotor to strong or concentrated acids, bases or
oxidizing agents, aromatic or halogenated hydrocarbons, esters or ketones.
WARNING –Do not operate or store centrifuge or its rotor below the 2oC minimum operating
temperature. At extreme low temperature (below -18oC) the rotor material is subject to cracking under
impact stress (such as dropping onto a hard surface).
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 centrifuge.
CAUTION –Maintain a 300 mm (11.8 inches) clearance envelope around centrifuge during operation.
Do not deposit any potentially hazardous materials within the CLEARANCE ENVELOPE.
CAUTION –Never operate the centrifuge without the rotor locked securely in place. Failure to properly
install and secure the rotor may result in damage to the centrifuge not covered by warranty.
WARNING –Inspect instrument for cracks or any physical damage to housing, cover and rotor.
Damage may result in unsafe operation; discontinue use until repairs have been performed.
CAUTION - Replace glass tubes used for rotor balancing after 10 spin cycles to reduce chances of
breakage due to the repeated stress of centrifugation. Replace Tube Inserts immediately if a tube
breaks during centrifugation.
CAUTION- The rotor (RTH8) has a finite lifespan of 50,000 cycles. Discontinue use after this period.
CAUTION -The cover interlock by-pass is for emergency use only. Misuse may expose the operator to
unsafe conditions.
CAUTION –Do not spray cleaning solutions directly onto the centrifuge bowl or housing; overspray
could reach the motor bearings or internal circuitry. Subsequent damage may not be covered by
warranty. Before using any cleaning or decontamination methods except those recommended,
operators should check with the manufacturer that the proposed method will not damage the
equipment.
CAUTION –Unplug the centrifuge from the wall outlet before cleaning or performing maintenance.
CAUTION –Follow Universal Precautions with all biological specimens, regardless of whether the
specimen is known to contain an infectious agent. (See references)
Please use the system as intended. Improper use of the StatSpin®Express 4 Horizontal Centrifuge
and/or its accessories may cause damage to the system, inaccurate results, or potentially nullify
warranties.

1
Section 1
Unpacking and Installation
Inspect Packaging
The StatSpin®Express 4 and its accessories are delivered in a single carton. If the centrifuge 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 StatSpin®Express 4 horizontal centrifuge (Product No. SSH4)
One centrifuge rotor (Product No. RTH8)
Eight rotor inserts for 13x100 mm tubes (Product No. SV09)
Eight rotor inserts for 16x100 mm tubes (Product No. SV07)
One line cord for use in North America only.
One Operator’s Manual
One manual latch release tool
One 1/8 inch hex key
Install
oPlace the centrifuge on a solid level surface suitable for operation of laboratory instrumentation.
oPosition the centrifuge 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 centrifuge.
WARNING - Maintain a 300 mm (11.8 inches) clearance around the centrifuge. Do not deposit
any potentially hazardous materials within the CLEARANCE ENVELOPE.
Connect Power
oPlug the centrifuge 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 instrument completes the power-on check it will give a two-beep ready signal. The three-
minute green indicator will illuminate. Press the stop 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 centrifuge.

2
Section 2
System Overview
Principle and Intended Use
For in-vitro diagnostic use to produce the rapid separation of whole blood contained in original collection
tubes.
The StatSpin®Express 4 is a high-speed horizontal bench top centrifuge used to rapidly separate blood
components in the original sample collection tubes. Do Not centrifuge substances with a density greater
than 1.2 kg/dm3.
The horizontal rotor included with the centrifuge accepts up to 8 primary 16x100mm primary blood tubes
with a maximum volume of 10 mL per tube. The operator selects a fixed spin time of 3, 5 or 10 minutes.
The rotation speed is 5100 rpm for the 3 and 5 minute cycles, producing a centrifugal force of 4000 xg at
a rotor radius of 13.8 cm.
The 10 minute cycle generates 3100 xg at 4500 rpm. This setting provides lower g-forces for procedures
which require a traditional spin.
Symbols and Definitions
REF
Product/Reference
Number
Indicates the Iris Sample Processing product/catalog
number
Caution
Statement of caution/warning: Read carefully.
Temperature
limitation
Indicates storage or operating temperature
restrictions
EC Representative
European Community Authorized Representative
IVD
For in vitro
diagnostic use
Indicates for use only as in-vitro diagnostic device
Non-sterile
Indicates a non-sterile product
S N
Serial Number
Indicates instrument serial number
Consult
Instructions
Refers operator to the instruction manual for
additional information
CE
European
Community
Compliance to IVD Directive
cUL / UL
Agency
Listed device with Underwriters Laboratory
Fuse
Rating: 2.5A , 250V , F
AC
Single Phase Alternating Current
IVD

3
Operator Controls
Start
The Start button initiates the selected cycle.
Stop/Open
The Stop/Open button interrupts the cycle and
releases the cover when the rotor has stopped.
3 Minute Cycle
The 3 min button selects a cycle of three minutes at
5100 rpm.
5 Minute Cycle
The 5 min button selects a cycle of five minutes at
5100 rpm.
10 Minute Cycle
The 10 min button selects a cycle of ten minutes at
4500 rpm.
Error/Service
The red indicator with an adjacent wrench symbol
flashes to signal an error condition or remains
continuously illuminated once the rotor reaches
50,000 cycles.
Error Indicators
StatSpin®Express 4 error conditions are signaled by a flashing red Error/Service indicator on the
control panel.
The cause of the error condition can be identified by the combination of green cycle time indicators
that are also flashing. See Error Codes Table.
To clear the error condition, correct the problem and press the Stop/Open button.
3 min
5 min
10 min
Error/Service
light flashing

4
Error Codes Table
Failure to reach speed in 30 seconds.
Confirm no obstruction in bowl area,
contact customer service.
Latch is not locked.
Confirm cover is fully seated in closed
position.
Rotor exceeded set speed.
Remove and inspect rotor, reinstall.
Cover is not closed.
Confirm cover is fully seated in closed
position.
Out of balance.
Confirm tubes are balanced in rotor and
centrifuge is on a level surface.
Rotor cannot maintain speed.
Contact customer service.
Shield is not installed.
Confirm shield is installed and in the
locked position.
Continuously illuminated
Error / Service indicator.
Cycle Counter
50,000 spins have been reached, contact
distributor or customer service to purchase
replacement rotor.
Accessories
Product No.
Description
SV02
Inserts for 3 mL tubes (10.25 x 64 mm) 4/pk.
SV05
Inserts for 2 mL tubes (10.25 x 47 mm or BD Microtainers) 4/pk.
SV06
Inserts for 7 mL tubes (16 x 75 mm) 8/pk.
SV07
Inserts for 10 mL tubes (16 x 100 mm) 8/pk. Included with centrifuge
SV08
Inserts for 5 mL BD tubes (13 x 75 mm) 8/pk.
SV09
Inserts for 7 mL tubes (13 x 100 mm) 8/pk. Included with centrifuge
SV10
Inserts for 5 mL Greiner tubes (13 x 75 mm) 8/pk.
SV11
Inserts for 4 mL BD RST tubes (13 x 100 mm) 8/pk
RTH8
8 place horizontal rotor. Included with centrifuge
3 min
5 min
3 min
5 min
10 min
10 min
10 min
3 min
3 min
5 min
5 min
10 min

5

6
Section 3
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. To recover
samples in the rotor, the cover interlock mechanism can be released manually by inserting the
manual latch release tool supplied with the instrument into the small hole located in the front of the
housing. Push the tool inward about one inch (25 mm) to release the latch.
CAUTION - The cover interlock by-pass is for emergency use only. Misuse may
expose the operator to unsafe conditions.
Removing and Installing the Rotor
The StatSpin® Express 4 is shipped with the rotor installed and supported by a shipping retainer.
To prevent possible damage to the centrifuge’s motor mount, it is important to remove the rotor
whenever the centrifuge is moved or shipped to another location.
CAUTION- The rotor (RTH8) has a finite lifespan of 50,000 cycles. Discontinue use of
rotor after this period. Replace with new rotor for continued use of centrifuge.
Before operating the centrifuge, ensure that the rotor is fully seated onto the motor shaft and
the hex screw is fully tightened.
To remove the rotor:
1. Open cover and remove shield. Grasp shield at the center opening and rotate clockwise.
Simply lift straight up and out of centrifuge housing.
2. Locate 1/8 inch hex key supplied and remove center screw of rotor hub.
3. Remove rotor lifting straight up and out of centrifuge.
To re-install rotor:
Note that the motor shaft has a D shape at the tip. This mates with the rotor and must be aligned for
the rotor to fully seat onto the motor shaft. Do not force rotors onto shaft. Damage could result to
motor and affect warranty.
1. Align “D” shape on shaft with rotor hub.
2. Slide the rotor onto the shaft and push down gently to seat.