Worthington K Series User manual

© Worthington Cylinders GmbH
English European Edition —January 2018
INSTRUCTION MANUAL
Medical Device
K SERIES Cryostorage System
CryoCe38K
CryoCe24K
CryoCe10K
CAUTION —SAFETY FIRST!
FOR PROPER AND SAFE OPERATION AND USE OF THIS
CRYOSTORAGE SYSTEM, IT IS ABSOLUTELY NECESSARY TO
REVIEW AND UNDERSTAND THE FOLLOWING WARNINGS AND
SAFETY PRECAUTIONS BEFORE ATTEMPTING TO INSTALL,
OPERATE OR MAINTAIN THE CRYOSTORAGE SYSTEM.
DO NOT ATTEMPT TO INSTALL, USE OR MAINTAIN THE
CRYOSTORAGE SYSTEM UNTIL YOU READ AND UNDERSTAND
THESE INSTRUCTIONS.
DO NOT PERMIT UNTRAINED PERSONS TO INSTALL, USE OR
MAINTAIN THIS CRYOSTORAGE SYSTEM.
IF YOU DO NOT FULLY UNDERSTAND THESE INSTRUCTIONS,
CONTACT WORTHINGTON INDUSTRIES OR YOUR DISTRIBUTOR
FOR FURTHER INFORMATION.
NOTE: Devices may differ slightly from the image

Instruction Manual
K SERIES Cryostorage System
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CONTENTS
1 USER DIRECTIONS.........................................................................................................................................5
2 SAFETY PRECAUTIONS................................................................................................................................6
3 SYMBOLS ..........................................................................................................................................................9
4 DEVICE DESCRIPTION ................................................................................................................................11
4.1 DEVICE INTENDED USE.......................................................................................................................11
4.2 DEVICE INTENDED LOCATION AND USER.....................................................................................11
4.3 DEVICE OVERVIEW AND KEY FEATURES......................................................................................12
4.4 CRYOSTORAGE SPECIFICATIONS...................................................................................................14
4.5 INVENTORY CONTROL SYSTEM SPECIFICATIONS.....................................................................15
5 INSTALLATION OF DEVICE.........................................................................................................................20
5.1 UNPACKING AND INSPECTION..........................................................................................................20
5.2 CONDITIONS OF OPERATION AND STORAGE..............................................................................21
5.3 LIQUID NITROGEN SUPPLY CONNECTION....................................................................................22
5.4 ELECTRICAL POWER SUPPLY CONNECTION...............................................................................23
5.5 FIRMWARE...............................................................................................................................................23
6 OPERATION OF DEVICE..............................................................................................................................24
6.1 SELECTING CRYOPROTECTANTS ...................................................................................................24
6.2 INITIAL FILL..............................................................................................................................................24
6.3 NORMAL FILL CYCLE............................................................................................................................25
6.4 ADDING AN INVENTORY CONTROL SYSTEM................................................................................27
7 OPERATION OF LIQUID NITROGEN LEVEL CONTROL SYSTEM .....................................................28
7.1 CONTROLLER INITIAL START UP......................................................................................................28
7.2 CONTROLLER SET UP..........................................................................................................................29
7.3 CONTROLLER CONFIGURATION AND CALIBRATION .................................................................37
7.4 CONTROLLER OTHER SETTINGS (ENGINEER MENU)................................................................48
7.5 CONTROLLER IN NORMAL OPERATION.........................................................................................48
7.6 CONTROLLER ALARMS........................................................................................................................49
7.7 CONTROLLER RESET...........................................................................................................................52
8 CARE AND MAINTENANCE OF DEVICE..................................................................................................54
8.1 GENERAL CONSIDERATIONS............................................................................................................54
8.2 INSPECTION AND MAINTENANCE SCHEDULE..............................................................................55
8.3 CLEANING THE STRAINER..................................................................................................................56
8.4 DEFROSTING THE CRYOSTORAGE SYSTEM................................................................................57
8.5 CLEANING AND DISINFECTING THE CRYOSTORAGE SYSTEM...............................................58

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8.6 NORMAL EVAPORATION RATE (NER) TEST..................................................................................59
8.7 TRANSPORT OF DEVICE.....................................................................................................................60
8.8 RETURN OF DEVICE.............................................................................................................................60
8.9 DISPOSAL OF DEVICE..........................................................................................................................60
9 WARRANTY TERMS......................................................................................................................................62
10 MANUFACTURER'S DECLARATION.......................................................................................................63
11 ADDITIONAL TECHNICAL DATA..............................................................................................................64
LIST OF APPENDIXES.....................................................................................................................................66

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TABLES AND FIGURES
Table 1 K SERIES Cryostorage System specifications.....................................................................14
Table 2 K SERIES Cryostorage System Inventory Control System specifications.............................15
Table 3 K SERIES Cryostorage System admissible ambient conditions ...........................................21
Table 4 Procedure for initial start up of the controller........................................................................28
Table 5 Timers/Clock Menu's options of the controller ......................................................................29
Table 6 Procedure for setting up the controller..................................................................................30
Table 7 Configuration/Calibration Menu's options of the controller....................................................37
Table 8 Procedure for configuration/calibration the controller............................................................37
Table 9 Engineer Menu's options of the controller.............................................................................48
Table 10 Procedure for resetting the controller .................................................................................52
Table 11 Recommended inspection and maintenance schedule........................................................55
Table 12 K SERIES Cryostorage System warranty terms.................................................................62
Table 13 Technical data of the K SERIES Cryostorage System........................................................64
Table 14 Radiated Immunity .............................................................................................................65
Table 15 Conducted Immunity ..........................................................................................................65
Figure 1 K SERIES CryoCe24K Standard Model..............................................................................12
Figure 2 Level Controller Display (type M505CE)..............................................................................13
Figure 3 Vial storage in boxes on racks ............................................................................................16
Figure 4 Rack arrangements for 50 ml cassettes (7-level configuration)...........................................17
Figure 5 Rack arrangements for 250 ml cassettes (5-level configuration).........................................18
Figure 6 Rack arrangements for 500 ml cassettes (5-level configuration).........................................19
Figure 7 Fill cycle and evaporation period time.................................................................................25
Figure 8 Sensor positioning ..............................................................................................................72
Figure 9 Thermocouple positioning...................................................................................................73
Figure 10 Suggested Form of Thermocouple for Vapour Phase Storage ..........................................75
Figure 11 Connection for Simultaneous Filling..................................................................................79
Figure 12 Connection for Sequential Filling.......................................................................................80
Figure 13 Connection for Gas Venting..............................................................................................81

Instruction Manual
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1 USER DIRECTIONS
IMPORTANT
READ THIS INSTRUCTION MANUAL!
Failure to follow the instructions in this manual can result in injury to personnel,
damage to your K SERIES Cryostorage System, or poor performance of this medical
device!
THIS INSTRUCTION MANUAL IS FOR PROFESSIONAL STAFF ONLY!
Do not permit any other untrained person to install, use or maintain this K SERIES
Cryostorage System.
THIS INSTRUCTION MANUAL IS AN ESSENTIAL ACCESSORY TO YOUR
K SERIES CRYOSTORAGE SYSTEM.
As such it is to be kept in a suitable place near the operating location of your K
SERIES Cryostorage System and should be accessible at all times to the persons
involved in the use, operation and maintenance. The instruction manual should be
included, if the K SERIES Cryostorage System is transferred to another location.
In this instruction manual, the following symbols are used:
Warnings and safety precautions:
This symbol indicates warnings and safety precautions which, in the context of a
potentially hazardous situation, shall followed to reduce the risk of any injury to
personnel, or malfunction or poor performance to the K SERIES Cryostorage
System.
Important and useful information:
This symbol indicates important and useful information which, in context of a
operating instruction, should followed to optimize the performance of the
K SERIES Cryostorage System.

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2 SAFETY PRECAUTIONS
IMPORTANT
The following safety precautions apply to the Worthington Industries K SERIES
Cryostorage System:
The safety precautions in this instruction manual are for your protection:
Before operating or maintaining your K SERIES Cryostorage System, become
familiar with the warnings and safety precautions.
It is the sole responsibility of the operating company to ensure refreshing
trainings.
Make sure that all applicable provisions have been followed before putting your
K SERIES Cryostorage System in operation.
Any damage can lead to malfunction:
Check your K SERIES Cryostorage System for faults and signs of damage
before use.
If the K SERIES Cryostorage System is suspected of malfunction, take it out of
operation immediately and affix appropriate warning labels to ensure that the K
SERIES Cryostorage System is no longer in use until the necessary repairs
have been carried out.
Extremely cold refrigerant may cause freezing injuries:
Your K SERIES Cryostorage System operates with liquid nitrogen, a cryogenic
liquid that is extremely cold and will be at a temperature of -196 ºC under
normal atmospheric pressure.
Accidental contact of the skin or eyes with nitrogen liquid or gas may cause a
freezing injury similar to frostbite.
Protect your eyes and cover your skin when handling stored samples, or when
transferring liquid nitrogen; or in any other instance where the possibility of
contact with cryogenic liquid, cold pipes, and cold gas may exist.
Use safety goggles or a face shield, and safety gloves, and long-sleeved
clothing that can be easily removed.

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IMPORTANT
The following safety precautions apply to the Worthington Industries K SERIES
Cryostorage System (continued):
Inlet pressure should not exceed 1.5 bar / 152 kPa:
Higher pressures could result in damage to equipment and/or sufficient
depletion of oxygen in the atmosphere to cause dizziness,
unconsciousness, or even death.
The liquid nitrogen supply pressure at the inlet to the refrigerator should be in
the range of 0.7 bar / 69 kPa to 1.4 bar / 138 kPa for optimum performance.
Higher operating pressures will increase transfer losses and create excessive
turbulence of the liquid in the refrigerator which can generate false signals to the
liquid level controller causing the refrigerator to underfill.
In “liquid phase” storage applications, excessive turbulence can cause splashing
which could result in personal injury and/or damage to the refrigerator.
When installing piping or fill hose assemblies, make sure a suitable safety relief
valve is installed in each section of plumbing between shut-off valves. Trapped
liquefied gas will expand greatly as it warms and may burst hoses or piping
causing damage or personal injury.
A relief valve is installed in the refrigerator plumbing to protect the line between
the customer supplied shut-off valve and the refrigerator solenoid valve.
Keep the location well ventilated:
A confined area without adequate ventilation can result in an atmosphere
that does not contain enough oxygen for breathing and will cause
asphyxiation, dizziness, unconsciousness, or even death.
Although nitrogen is non-toxic and non-flammable, it is an colorless, odorless,
and tasteless gas, and cannot be detected by the human senses, and will be
inhaled normally as if it were air.
Ensure there is adequate ventilation where your K SERIES Cryostorage System
is used and store liquid refrigerant supply containers only in a well ventilated
area.
In case of First Aid: Have someone call for emergency medical services
immediately and do not leave victims of asphyxia alone at all times.

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IMPORTANT
The following safety precautions apply to the Worthington Industries K SERIES
Cryostorage System (continued):
Electrical shock can kill:
Always disconnect the electrical power cord before you attempt any repair or
maintenance on your K SERIES Cryostorage System.
The liquid level controller used with the refrigerator operates from 24 VAC.
However, the external transformer does have a 230 VAC primary power supply.
Connect the refrigerator only to the mains power supply with protective
conductor.
Always make sure that the wiring and electrical installations in any given room
comply with the applicable standards and regulations before using the device in
the room. Take measures to ensure that any sources of magnetic induction of
external origin (e.g., emission of rays or high temperatures) are kept to an
absolute minimum.
Do not make any modifications:
Repairs and maintenance services to your K SERIES Cryostorage System must
be carried out by service personnel instructed and authorized only by
Worthington Industries.
Use only approved accessories and replacement parts:
Your K SERIES Cryostorage System is supplied with Worthington Industries
approved accessories and replacement parts.
Except Printers and PCs, only devices and accessories approved by
Worthington Industries may be connected to the controller or power supply.
Complete the service history log:
Arrange for the regular inspections and checks to be carried out to this
instruction manual. Sign off in the service history log each time service and
maintenance is finished to your K SERIES Cryostorage System.
For more detailed information concerning safety precautions and safe
practices to be observed when handling cryogenic liquids refer to CGA
publication P-12 “Safe Handling of Cryogenic Liquids” available from the
Compressed Gas Association, www.cganet.com; and the comparable
publications from the European Industrial Gases Association, www.eiga.eu.

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3 SYMBOLS
IMPORTANT
The following symbols apply to the Worthington Industries K SERIES Cryostorage
System:
CE mark with Notified Body number
Declares compliance with EU Directive 93/42/EEC (Medical Device
Directive)
20XX
Manufacturer as defined in EU Directive 93/42/EEC
Combined with year of manufacture of medical device
Manufacturer’s model reference of medical device
Manufacturer’s serial number of medical device
Follow this instruction manual for important warnings and safety
precautions
Danger!
Use protective gloves
Use protective goggles

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IMPORTANT
The following symbols apply to the Worthington Industries K SERIES Cryostorage
System (continued):
AC voltage
DC voltage
Protective earth conductor
Ingress protection rating
Transport and move medical device in upright position
Do not stack medical devices
Fragile, handle medical device with care
Keep medical device away from sunlight and heat
Keep medical device dry
Temperature limits to which the medical device can be safely exposed
Humidity limits to which the medical device can be safely exposed
Atmospheric pressure limits to which the medical device can be safely
exposed
Do not dispose of medical device or parts with unsorted non-recyclable
waste
The packaging materials are recyclable
Do not dispose of the packaging in the household waste
Dispose the packaging through waste collection or recycle where
facilities are available

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4 DEVICE DESCRIPTION
4.1 DEVICE INTENDED USE
The Worthington Industries K SERIES Cryostorage System is a medical device intended to use
for cryogenic long-term storing of bags, vials and similar containers
with biological specimens of human origin, such as cord blood, stem cell or semen
that will eventually be investigated or introduced into the human body
at extremely low temperatures from -100 °C to -196 °C
supplied by liquid nitrogen as cyrogenic agent under normal atmospheric pressure.
Any other use is not declared by the manufacturer!
Worthington Industries and the distributors of the K SERIES Cryostorage System refuse
all liability when the device is not used in compliance with this instruction manual.
4.2 DEVICE INTENDED LOCATION AND USER
The Worthington Industries K SERIES Cryostorage System is a medical device intended to be used in
locations in the area of professional health care facilities, such as hospitals, clinics, medical practices,
medical laboratories.
The environment of professional health care does not include every arbitrary
location. So this environment comprises not areas, where sensitive facilities or sources
of intense electromagnetic interference are located, such as radio frequency (RF)
shielded rooms for magnetic resonance imaging (MRI), areas in operation rooms with
active high frequency (HF) surgical equipment, electrophysical laboratories or areas
where short-wave therapy equipment is used.
For further details on the admissible ambient conditions for operating the K SERIES
Cryostorage System, see section 5.2.
The Worthington Industries K SERIES Cryostorage System is a medical device
intended to be used by trained professional users, such as clinicians, medical and
laboratory technicians, medical and laboratory assistants and other health care
professionals, experienced with cyrogenic agents and cryogenic equipment.
Any other untrained person is not permitted to use the K SERIES
Cryostorage System in any way!
Worthington Industries and the distributors of the K SERIES Cryostorage System refuse
all liability when the user, operator or other person is not sufficiently instructed to use
this K SERIES Cryostorage System, with reference to this instruction manual including

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all relevant aspects for the proper operation and necessary safety precautions, and any
inspections to be performed prior to each application, and maintenance to be carried
out in certain intervals.
4.3 DEVICE OVERVIEW AND KEY FEATURES
The Worthington Industries K SERIES Cryostorage System is a state-of-the-art cryogenic storage
system with the following key features:
can be used in either liquid or vapor phase under normal atmospheric pressure
uses liquid nitrogen as cryogenic agent that is non-toxic and non-flammable
stainless steel vacuum vessel with superior vacuum performance
wide-neck opening allows easy loading and retrieval of samples
robust design of smooth surfaces for easy cleaning and disinfection
thermally insulated and lockable lid
microprocessor based controller with intuitive touch controls for:
oliquid level and temperature monitoring, and alarms
ologging of temperature, levels, alarms, fill activity etc.
oremote alarm (optional)
mounted lockable casters to enable limited mobility for cleaning purposes
variety of racks and boxes allows a wide range of storage capacity to fit individual sample
management
Figure 1 K SERIES CryoCe24K Standard Model

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The Worthington Industries K SERIES Cryostorage System is available with the following types of
level controller display:
M505CE (standard version), designed for fitting to CryoCe10K and CryoCe24K
M505CE-B (boxed version), designed for fitting to CryoCe38K
Figure 2 Level Controller Display (type M505CE)
NOTE Level controller displays are identical for type M505CE and M505CE-B
Use only Worthington Industries approved electronic liquid level controllers:
If other liquid level controllers are required, please contact Worthington Industries before
putting your K SERIES Cryostorage System into operation.

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4.4 CRYOSTORAGE SPECIFICATIONS
The Worthington Industries K SERIES Cryostorage System is designed for the following models:
Table 1 K SERIES Cryostorage System specifications
MODEL
CryoCe10K
CryoCe24K
CryoCe38K
Dimensions (mm)
Height
111.8
111.8
1245
Width/Depth
587 x 775
864 x 965
1067
Internal Useable Height
737
737
737
Internal Diameter
533
787
991
LN2 Capacity (litre)
165
365
590
Evaporation Rate* (litre/day)
5.0
7.0
8.0
Empty Weight (kg)
111
184
256
Maximum Gross Weight (kg)
including unit, controls and plumbing
assembly, liquid nitrogen, racks,
boxes, vials and samples
332
669
1037
Static Holding Time* (days)
33
52
74
NOTE * Evaporation Rate and Static Holding Time are nominal. Actual rate may be affected by the
nature of the contents, atmospheric conditions, container history and manufacturing tolerances.
The K SERIES Cryostorage System has a maximum weight capacity which
exceeds the maximum amount of liquid nitrogen the refrigerator is capable of
holding.
Generally, as samples are added to liquid phase storage, the stored samples and
inventory control system are heavier than the liquid nitrogen they displace. In vapor-
phase storage applications, where the liquid nitrogen is found only in the bottom portion
of the refrigerator, the weight of contents is determined more by the weight of the stored
product.

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4.5 INVENTORY CONTROL SYSTEM SPECIFICATIONS
The Worthington Industries K SERIES Cryostorage System standard models will accommodate
inventory control systems or provide unobstructed storage area for larger samples:
Table 2 K SERIES Cryostorage System Inventory Control System specifications
MODEL
CryoCe10K
CryoCe24K
CryoCe38K
Racks per 25 cell boxes
4
6
6
Racks per 100/81 cell boxes
7
17
28
Cell box size
5 in. x 5 in. (127 mm x 127 mm) square
3 in. x 3 in. (76 mm x 76 mm) square
Shelves per rack
13
13
13
Vials per 2 ml
(12.5 mm O.D. internal thread)
10 400
24 050
38 350
Straws per 0.5 cc
(10 per goblet, 2-13 mm goblets per can)
44 000
59 400
114 000
Bags per 50 ml (7 level rack)
343
805
1 407
Bags per 250 ml (5 level rack)
235
535
870
Bags per 500 ml (5 level rack)
185
475
680
NOTE Various box and bag sizes and capacity details are available upon request.

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The following images show the different rack arrangements for the K SERIES Cryostorage System:
Figure 3 Vial storage in boxes on racks

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Figure 4 Rack arrangements for 50 ml cassettes (7-level configuration)

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Figure 5 Rack arrangements for 250 ml cassettes (5-level configuration)

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Figure 6 Rack arrangements for 500 ml cassettes (5-level configuration)

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5 INSTALLATION OF DEVICE
Installation as well as all associated inspections should only be performed
by qualified persons:
These persons are qualified due to their special education and their practical
experiences, in particular with regard to the relevant legislation and standards, to
recognize the potential impact and hazards and to assess the necessary measures.
5.1 UNPACKING AND INSPECTION
The Worthington Industries K SERIES Cryostorage System is delivered in new condition.
For your own protection, take time to visually inspect each shipment for external damage.
Open the shipping containers
Use the packing list to check off each item as the system is unpacked
Inspect for damage
Be sure to inventory all components supplied before discarding any shipping materials
All claims for damage (apparent or concealed) or partial loss of shipment must be
made in writing within 5 (five) days from receipt of goods.
If damage or loss is apparent, please notify the shipping agent immediately.
In case of parts or accessory shortages, advise Worthington Industries immediately.
Worthington Industries and the distributor cannot be responsible for any missing parts
unless notified within 10 (ten) days of receipt of shipment.