Thermo Scientific Cryofuge 5500i GMP User manual

Thermo Scientific
Cryofuge 5500i GMP
Instructions for Use
20057801-e• 07/ 2020
Visit us online to register your warranty:
thermofisher.com/labwarranty

How to use this manual
Please, use this manual to get acquainted
with your centrifuge and its accessories.
The manual helps you to avoid inappropriate handling.
Make sure to always keep itclose to the centrifuge.
Amanual that is not kept handy cannot provide aid
against improper handling and thus against dam-
age to individuals and surrounding.
The manual contains chapters on:
Safety regulations
Instrument description
Transport and installation of the centrifuge
Rotors and accessories
Use of the centrifuge
Maintenance and care
Troubleshooting
Technical data
Index
Overleaf you will find a graphical
illustration of the control panel and a
survey of the most important functions
Unfold, please

Before switching on the centrifuge
please read this manual!
display for optional
accessories
acceleration
profiles
deceleration
profiles temperature
program display
key switch
program selection
program storage key
speed/RCF run time
switch key
rpm-/RCF-display
quick run
start
open lid
stop
bucket selection “set” keys pre-temperature-regulation
The mains switch is located on the right-hand sidepanel.
Pressed up = ON I
Pressed down = OFF 0
“set” keys

Control panel of the Cryofuge
®
5500i GMP
Displays
Program selection
Program selection key: stepwise recall of programs
Switch key: open/shut program storage
Acceleration profiles (1= slow ........ 9= fast)
display: acceleration profile last set 1-9
Deceleration profiles (1= slow ........ 9= fast)
display: deceleration profile last set 1-9
Speed / RCF
run: actual value of speed or RCF after actuating
switch key
end: “End”
lid open: “OPEN”
“Lift Lid” (if lid is not automatically lifted off)
Keys
start : normal start of the centrifuge
stop : manual stop of a run
open lid: open lid (possible only with theinstrument
switched on)
Quick run: short-term operation of the centrifuge as long as
key remains pressed
switching
rpm/RCF: switching between rpm and RCFdisplay
Bucket set: setting of the bucket number
Pretemp : pre-temp-function
“set” keys: stepwise increase/decrease of set values
Short pressing of any of these keys: switching from actual to set
value, signaled by flashing display
(before start)
lid closed: “0” with flashing point
(rotor not yetidentified)
error code: will flash in display
Run time
time selection: - remaining run time up to 0
continuous - run time passed
operation (hold) (in minutes and seconds)
“quick run”: - run time passed
(in minutes and seconds)
Temperature
run: actual sample temperature in°C
(in temperature equilibrium)
Troubleshooting see chapter “Troubleshooting”):
E-00: motor blocked
E-03: speed measurement
E-08: over voltage; over temperature in the electronics
E-14: no rotor or rotor identification not possible
E-17: lid cannot be opened
E-23: under voltage; over temperature in the motor or
excessive pressure in the refrigerator
rotor: set speed higher than highest permissible speed
of the rotor
bAL : imbalance
Lid: lid burst open during run or open

1
Contents
For your safety........................................... 3
Proper use ............................................................... 3
Improper use ........................................................... 3
Centrifuging hazardous materials............................ 3
Handling the centrifuge............................................ 4
Conformity to current standards .............................. 5
Safety instructions in this manual............................ 5
The Cryofuge
®
5500i GMP ......................... 7
Safety systems ........................................................ 8
Schedule of parts supplied ...................................... 8
Function and features.............................................. 9
Before the use.......................................... 13
Setting up and connecting the centrifuge .............. 13
The correct installation locations ........................... 13
Transporting centrifuge.......................................... 13
Connection conditions ........................................... 15
Commissioning ...................................................... 15
Rotors and accessories .......................... 17
Adapter and accessories ....................................... 22
Handling rotors ...................................................... 29
Swinging Bucket Rotors..................................... 29
LH-4000 ............................................................. 29
LH-4000 W......................................................... 29
Contents
BIOshield®- Rotor............................................... 30
Highplate®- Rotor ............................................... 31
Handling micro plates......................................... 32
Diagnostik™- Rotor............................................ 33
Highconic®- Rotor............................................... 33
LAC-250 ............................................................. 34
Aerosol-tight operation........................................... 36
Checking of aerosol-tight bio-containment......... 40
Operation.................................................. 41
Switching on the centrifuge.................................... 41
Actuating the lid ..................................................... 41
Opening the lid ................................................... 41
Closing the lid..................................................... 41
Installing the rotor .................................................. 42
Loading the rotor.................................................... 43
Maximum loading ............................................... 43
Filling the centrifuge tubes ................................. 44
Maximum permissible load difference................ 44
Inserting the centrifuge tubes............................. 45
Entering parameters .............................................. 48
Key switch.............................................................. 48
Acceleration / Deceleration curves ........................ 49
Switching from speed to RCF display .................... 49
Bucket selection for swinging bucket rotors.......................49

2
Contents
Selecting speed ..................................................... 50
Entering the RCF value ......................................... 51
RCF value explanation....................................... 51
Selecting run time .................................................. 52
Fixed run time .................................................... 52
Continuous operation......................................... 52
Limited time mode.............................................. 53
k-factor ............................................................... 53
Selecting the temperature ..................................... 54
Pretemp function.................................................... 54
Starting the centrifuge............................................ 55
Imbalance display .................................................. 55
Changing the settings during the run..................... 55
Stopping the centrifuge.......................................... 56
At limited run time .............................................. 56
At continuous operation ..................................... 56
Temperature control during standby...................... 56
Working with programs .......................................... 57
Program display ................................................. 57
Entering / changing a program........................... 57
Centrifuging with a program............................... 58
“Quick Run”............................................................ 58
Removing the rotor ................................................ 59
Audible alarm......................................................... 59
Putting the centrifuge out of operation................... 60
WEEE Compliance ................................................ 60
Maintenance and care ............................. 61
Maintenance to be performed by the customer ..... 61
Cleaning ............................................................. 61
Disinfection......................................................... 62
Decontamination ................................................ 64
Autoclaving......................................................... 64
The Thermo Fisher Scientific Service offer............ 65
Warranty conditions ............................................... 65
Troubleshooting....................................... 67
Emergency lid release ........................................... 67
Troubleshooting you can handle yourself .............. 69
If customer service is required............................... 77
Technical Data.......................................... 78
Electrical connections / fuses ................................ 79
Appendix .................................................. 80
Acceleration and deceleration profiles................... 80
Speed/RCF diagrams ............................................ 96
Index ....................................................... 104

Safety instructions
3
For your safety
These centrifuges are manufactured according to
current technical standards and regulations. Nonethe-
less, centrifuges may pose danger to individuals and
surrounding if
they are not used as designed,
they are operated by untrained personnel,
their design is improperly changed,
the safety instructions are not followed.
Therefore, personnel involved with operation and
maintenance of the centrifuge must read and follow
the safety instructions.
In addition, the pertinent regulations for prevention of
accidents must be strictly followed.
This manual is an integral part of the centri-
fuge assembly and must be kept close at
hand at all times.
Proper use
The centrifuge is designed to separate liquid-
suspended materials having different densities and
particle size, respectively (maximum sample density is
1.2 g/cm³ {ml} at maximum speed).
Improper use
During a run, a safety zone of 30 cm around the centri-
fuge must be maintained where neither persons nor
hazardous materials may be present.
The centrifuge may cause harm to its user or other
persons or may damage goods if safety measures are
not followed:
Centrifuging hazardous materials
The centrifuge is neither made inert, nor is it
explosion-proof. Therefore, never use the centrifuge
in an explosion-prone environment.
Do not centrifuge explosive or flammable sub-
stances. The same holds for substances prone to
react violently with each other.
When damages to the power cord or at
casing are noticed the centrifuge must
to be set out of operation!

Safety instructions
4
Do not centrifuge toxic or radioactive substances or
pathogenic microorganisms without suitable safety
systems.
If microbiological samples of risk group II (according
to “Laboratory Bio-safety Manual” of WHO) are be-
ing centrifuged, aerosol-tight bio-seals have to be
used.
For materials in a higher risk group, more than one
precaution is required.
Should toxins or pathogenic substances enter the
centrifuge or its parts, you must perform appropriate
procedures for disinfection (see “Maintenance and
care – Disinfection”).
Strongly corrosive substances that may cause dam-
age to materials and reduce the mechanical
strength of the rotor may be centrifuged only inside
protective tubes.
Handling the centrifuge
Use only original accessories for the centrifuge. The
only exceptions are common glass or plastic centri-
fuge tubes if they are approved for the rotor speed
and RCF values.
Never use the centrifuge unless the rotor is properly
installed.
You may usethe centrifuge only with a properly
loaded rotor. You mustnot overload the rotor.
Strictly follow the rules and regulations for cleaning
and disinfection
If the rotor or the rotor lid shows signs of corrosion
or wear, you must stop using it.
Never open the lid manually if the rotor is still turn-
ing.
You may usethe emergency lid release only in case
of emergency, e.g. during an interruption of power
supply
(see chapter “Troubleshooting”).
Never use the centrifuge with an opened lid.
Never use the centrifuge if the front panel has been
partially or totally removed.
Changes in mechanical or electrical components of
the centrifuge may only be carried out by individuals
authorized by Thermo Fisher Scientific.

Safety instructions
5
Conformity to current standards
These centrifuges are manufactured and tested
according to the following standards and regulations:
- For all voltages
IEC 61010
- For 230 V only
Please get acquainted with the details of the test stan-
dards from the technical data.
Safety instructions in this manual
This symbol denotes potential hazards to
persons.
This symbol denotes potential damage to
the centrifuge or parts in its immediate
surroundings.
Attention: general danger place
General comments are marked with this
symbol.
Before switching on the centrifuge please
read this manual

Safety instructions
6
CAUTION: This product is intended for General
Laboratory Use. It is the customer’s responsibility to
ensure that the performance of the product is suitable
for customer’s specific use or application.

Description of the Cryofuge®
7
The Cryofuge®5500i GMP
The figure below shows a Cryofuge®5500i GMP with
the lid open and a LH-4000 rotor installed.
Description
The Cryofuge®5500i GMP is a large-scale universal
centrifuge with an internal, water-cooled refrigeration
system for biotechnical and pharmaceutical research,
as well as for clinics and blood transfusion centers. It
is optimized for the highest level of sample throughput
and automated laboratory processes in large-scale
laboratories and other operations within the pharma-
ceutical and biotechnological industry.
In addition, the Cryofuge® 5500i GMP is a compact
centrifuge for blood component separation in transfu-
sion centers.
The Cryofuge®5500i GMP is designed especially in
accordance with the requirements for GMP (Good
Manufacturing Practice). This is characterized, among
other things, by a completely encapsulated casing
which suppresses the emission of particles and thus
prevents contamination of the clean room environ-
ment.
Smooth surfaces and a rubber sealing between centri-
fuge and platform guarantee thorough cleaning. In this
way the device is especially suitable for “pure rooms”
in accordance with EC-GMP Guide Annex 1 and FDA
Aseptic Guide.
Cooling water is necessary for the
operation of this GMP Cryofuge!

Description of the Cryofuge
®
8
Safety systems
The Cryofuge®5500i GMP is equipped with a number
of safety systems:
Casing and lid made of 8 mm armored steel sheet.
Lid with sight glass
Lid lock with safety check
Schedule of parts supplied
Accessories supplied with the centrifuge are:
connection cable
a wrench for fixing the rotor
You can open the centrifuge lid only when the cen-
trifuge is switched on and the rotor has come to a
stop. Start the centrifuge with properly locked lid
only.
Automatic rotor identification
Electronic imbalance detection as a function of
rotor (SMARTspinTM)
corrosion protective oil
installation set with instrument feet,
mounting tools and
box level
Do not tamper with the safety system!
The printed documents include the delivery docu-
ments and this Manual.
The rotors are not included in the schedule of
parts supplied of the Cryofuge®.

Description of the Cryofuge®
9
Function and features
Basic unit/ function Description / feature
Assembly / casing galvanized steel sheet base with armored steel chamber
Chamber stainless steel
Drive brush less induction drive
Keys and display key pad and display elements covered by an easy-care protective cover
Control microprocessor controlled by “Easycontrol II”
Operating memory last set parameters remain
Program memory values are stored until new data will be entered after starting.
Functions RCF-selection, quick run, pretemp, temperature regulation during standby
Acceleration and deceleration profiles 9 acceleration and 9 deceleration profiles
Rotor identification automatic
SMARTspinTM
imbalance detection system
electronic, effective as a function of rotor and speed
Lid lock motor assisted lid locking

Description of the Cryofuge
®
10
The Easycontrol user interface
Function Feature
Program display free program selection
[ - ] operating memory
[ 1...9 ] memory capacity for set values
[ ] “quick run”-mode
Acceleration / deceleration profile 1 = slow, ... 9 = fast acceleration / deceleration curve
Speed selection adjustable from 300 rpm to 10 000 rpm, in 10 rpm increments
RCF selection after actuating RCF switch key, the RCF value can be entered
Time selection adjustable in seconds up to 9 min 59 sec,
in the range of 10 min up to 99 min in minutes,
“hold”-mode: continuous operation
Run time display in “quick run” mode in second increments
Temperature selection adjustable from -9 °C to +40 °C, in one degree increments
End of centrifugation the speed display will read “End”

Description of the Cryofuge®
11
Function Feature
Lid opening
automatic unlocking via “open lid” key ( )
(unlocking in case of power failure: see chapter “Troubleshooting”)
Start
start key ( )
Stop
stop key ( )
“quick run” mode
pressing the “quick run” key ( ) activates maximum acceleration up to the
maximum permissible speed of rotor; upon key release centrifuge stops with
maximum deceleration power.
Diagnostic messages
alternating display “rotor”/maximum speed or RCF
(speed selected exceeds max. speed of the rotor)
lid has not been lifted off the lock during opening:
display “lift lid” (manual lifting of lid required)
general instrument malfunction
(error messages with ERROR codes, see “Troubleshooting”)

Description of the Cryofuge
®
12
Notes

Before the use
13
The setting up and connecting of the
Cryofuge 5500i GMP may be imple-
mented exclusively by trained special-
ist personnel only!
Before the use
Setting up and connecting the centrifuge
The correct installation locations
The utilization of the centrifuge has to be implemented
in interior compartments. The installation locations
must meet these requirements:
A security area of at least 30 cm must be kept
around the centrifuge. No dangerous materials may
be located there during the centrifugation.
The floor must be stable and resonance-free.
The centrifuge must be protected against heat and
strong solar radiation.
Transporting centrifuge
UV radiation reduce the durability of
plastics.
Place the centrifuge, as well as ro-
tors and accessories of plastic, so
that they are not exposed to direct
solar radiation!
The centrifuge can be damaged
during transport through shock
impacts!
Transport the centrifuge in the
upright position, without rotor and
only in the corresponding special
packing.
Ensure sufficient protection!

Before the use
14
Mains switch
Scanner connection
Optional for HERANET
Service inter-
Mains inlet
Water drain
Zero-potential outlet for
a water-circulation-
Water supply

Before the use
15
The mains switch must not be used to
interrupt the centrifuge run (except for
emergencies). For this, the STOP key
is provided!
Connection conditions
Before the centrifuge is connected with the mains net-
work, the following must be ensured:
1. A water connection is available for a ¾" screwed
connection:
Min. flow rate of the water 10 litres per
minute Water pressure from 2.5 bar to 6.0
bar Water temperature 14 °C to 18 °C
2. Water runoff (pressure-free) is available
3. The voltage information on the type designation
plate is identical to the available mains voltage
4. The mains connection at a plug socket with protec-
tive grounding takes place.
The Cryofuge GMP can be connected
to a closed-circuit in-house water
circulation system. The connection to
a water-circulation-cooler (e.g. HWK
4600/A, Order No. 76007473) is also
possible.
Commissioning
Connect plug with plug socket.
Ensure water supply and return flow.
Activate mains switches in front to the right.
All strainer segment displays and diodes light up after
that for short time for the purpose of verification
(system check).
The hoses for the water connection
may be exchanged only by technical
personnel.
Shortening of the hoses is not
permissible!

Before the use
16
Notes