K2 Scientific K215SDF-BB-BF User manual

Use and Operational Manual
Blood Bank

K2 Scientific
3029 Horseshoe Ln
Charlotte, NC 28208
800-218-7613 [email protected]
technical support: [email protected]
website: k2sci.com
Manufacturer’s responsibility:
The manufacturer us responsible as to safety and correct use of these refrigerators only if:
•The operations of setting, change and repair must be performed by authorized personnel.
•The electrical installation has been carried out in conformity with the instructions.
•The device is used in accordance with this manual.
Special warnings: not to be used in the presence of explosive gases or
mixtures/ not intended for flammable material storage.
Do not for use close to sources with high magnetic or electric fields.

Index
1. STANDARDS AND GENERAL WARNINGS ----------------------------------------------------------- 7
1.1 TESTING AND INTENDED USE ------------------------------------------------------------------------------------------------------------- 8
1.2 INTRODUCTION ------------------------------------------------------------------------------------------------------------------------------------ 8
1.3 PRODUCT DESCRIPTION --------------------------------------------------------------------------------------------------------------------- 9
1.4 CERTIFICATION ----------------------------------------------------------------------------------------------------------------------------------- 9
1.5 GENERAL SAFETY REGULATIONS ------------------------------------------------------------------------------------------------------ 9
1.6 CUSTOMER’S RESPONSIBILITIES ------------------------------------------------------------------------------------------------------10
1.7 CUSTOMER SERVICE REQUESTS ------------------------------------------------------------------------------------------------------10
1.8 ORDERING OF SPARE PARTS ------------------------------------------------------------------------------------------------------------11
1.9 PRODUCT CONFIGURATION ---------------------------------------------------------------------------------------------------------------11
1.10 MATERIALS AND REFRIGERANTS ---------------------------------------------------------------------------------------------------11
1.11 WARNING LABELS ----------------------------------------------------------------------------------------------------------------------------11
1.12 FDA LABELS -------------------------------------------------------------------------------------------------------------------------------------14
2. INSTALLATION ------------------------------------------------------------------------------------------- 16
2.1 TRANSPORTATION AND HANDLING --------------------------------------------------------------------------------------------------16
2.2 POSITIONING --------------------------------------------------------------------------------------------------------------------------------------16
2.3 WIRING AND ELECTRICAL HOOK-UP -------------------------------------------------------------------------------------------------17
2.4 SET UP OPERATIONS -------------------------------------------------------------------------------------------------------------------------17
2.5 RE- INSTALLATION -----------------------------------------------------------------------------------------------------------------------------18
2.6 SCRAPPING AND DISPOSAL --------------------------------------------------------------------------------------------------------------18
2.7 REMOTE ALARM CONNECTION ----------------------------------------------------------------------------------------------------------18
3. OPERATION ------------------------------------------------------------------------------------------------- 19
3.1 STARTING CYCLE --------------------------------------------------------------------------------------------------------------------------------19
3.1.1 Time Cycle -------------------------------------------------------------------------------------------------------------------------------------21
3.1.2 Product temperature Cycle --------------------------------------------------------------------------------------------------------------21
3.2 USER MENU -----------------------------------------------------------------------------------------------------------------------------------------22
3.2.1 USB option --------------------------------------------------------------------------------------------------------------------------------------22
3.2.1 I/O STATUS ------------------------------------------------------------------------------------------------------------------------------------23
3.2.3 HACCP download ----------------------------------------------------------------------------------------------------------------------------23
3.2.4 Using a property Software to trace HACCP data --------------------------------------------------------------------------------24

3.2.5 Access the source HACCP files for own purpose -------------------------------------------------------------------------------27
4 TROUBLESHOOTING -------------------------------------------------------------------------------------- 29

STANDARDS AND GENERAL WARNINGS
7
1. STANDARDS AND GENERAL WARNINGS
PRODUCTS APPLICABLE TO THIS MANUAL
The present manual is exclusively valid and applicable to the following products range:
Plasma Freezer
Adjustable temperature control range: lowest T = -40°C (-40°F), highest T = -30°C (-22°F)
Operating temperature: - 40°C (-40F)
Factory pre-set to: -40°C (-40°F)
Models:K215SDF-BB-BF
Environmental Operating Conditions
-Nominal environmental operating condition: Climatic class 4 ( 30°C, HR%=55%);
- Ambient temperature operating range: 10°C~40°C;
- Humidity: 65% maximum, non-condensing;
-Electrical supply: 220v/60Hz/3f;
-Altitude: 2000 meters MSL (Mean Sea Level);
- Usage: This product is intended for use indoors only.
Model
Number
W
D
H
SetPoint
Temp.
lec. V/Ph/Hz
Gas Type
K215SDF-BB-BF
800mm
(31 ½ in)
835mm
(32 7/8 in)
1964mm
(77 5/16 in)
-40°C
(-40F) 220V/3/60 R452A

STANDARDS AND GENERAL WARNINGS
8
Note: All relevant data referring to these products can be found on the data label visible on the
rear part of the cabinet. Here is an example of the label:
1.1 TESTING AND INTENDED USE
This equipment is tested in compliance with established regulations and then shipped ready for
use.
•This product is intended for use:
•As a rapid freezer in research use.
•As a medical device for freezing samples for diagnostic use (storage of samples not
intended to be re-introduced to the human body).
•As a medical device for freezing blood components for storage and eventual re-introduction
to the human body.
This Product is not intended for long-term storage.
Registration: This medical application is considered a Class II medical device by the FDA.
“If the equipment is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired.”
1.2 INTRODUCTION
This manual provides all instructions required for the correct use of the equipment and to keep it
in optimal condition. It also contains important user safety information. The following professional
roles are explained in order to define individual responsibilities:
Installer: a qualified technician who installs the equipment in accordance with these instructions.
User: the person who, after having read this manual carefully, uses the equipment in
accordance with the intended specification of use described in this manual. User’s

STANDARDS AND GENERAL WARNINGS
9
responsibilities: ensure that the product is kept at suitable temperatures in an ambient
environment less than +40°C (104°F); be aware of the regulations governing the conservation of
products to refrigerate and to observe any whatsoever hygiene indications that may be
applicable. The user is obliged to carefully read the manual and refer to its information at all
times. Particular attention must be paid to safety warnings (refer to Section 1.5).
Routine maintenance technician: qualified operator able to perform routine maintenance of
the equipment by following the instructions in this manual.
Service engineer: qualified technician, authorized by the manufacturer to perform
extraordinary maintenance of the equipment.
The symbol appears at certain points in the manual to draw the reader’s attention to
important safety information.
The manufacturer declines any responsibility in case of improper use of the equipment
deviating from the reasonably construed intended use, and for all operations carried out that
are not in compliance with the instructions reported in the manual.
This manual must be stored in an accessible and known place for all operators (installer,
user, routine maintenance technician, service engineer).
1.3 PRODUCT DESCRIPTION
The equipment comprises a single body with paneling in various materials and insulation with
expanded polyurethane foam. The equipment instruments are located on the front panel where the
electrical wiring is housed. The interior parts are fitted with suitable supports for shelves. The
doors are fitted with an automatic return device and magnetic seal elements. During the design
and construction stage all measures have been adopted to implement total safety including radius
interior corners, funnel-shaped base panel to convey condensate to exterior, no rough surfaces,
fixed guards protecting moving or potentially dangerous parts.
1.4 CERTIFICATION
The appliances listed in this manual are manufactured in accordance with the following regulations:
-UL/CSA 61010-1 3rd edition and IEC 61010-2-011
-CISPR 11:2009 + A1:2010;
-IEC 61000-4-2:2008;
-IEC 61000-4-3:2006 + A1:2007 + A2:2010;
-IEC 61000-4-3:2006 + A1:2007 + A2:2010;
-IEC 61000-4-4:2012;
-IEC 61000-4-5:2005;
-IEC 61000-4-6:2013;
-IEC 61000-4-8:2009;
-IEC 61000-4-11:2004
1.5 GENERAL SAFETY REGULATIONS
Read this manual carefully and follow the instructions contained herein.
The user assumes full responsibility in case of operations carried out without observing the
instructions in the manual.
Do not use this product with flammable gases or flammable solvents.

STANDARDS AND GENERAL WARNINGS
10
Do not store flammable gases, flammable liquids or flammable solids in these units.
Primary general safety regulations:
Do not touch the unit with wet hands and/or feet. Do not use the equipment with bare feet;
Do not insert screwdrivers or other pointed objects between guards or moving parts of the
equipment;
Do not pull the power cord to disconnect the equipment from the electrical mains Make sure
that the equipment is not used by unsuitably qualified persons;
Before performing any cleaning or maintenance on the equipment disconnect it from the
electrical mains by switching off the main switch and extracting the plug;
Never use any metallic scouring pads, brushes, abrasive cleaners or strong alkaline
solution on any surface.
The relocation of the unit must be performed by qualified personnel. Do not shift the
refrigerator from side to side as this may create leakage point across the cooling unit
piping.
In case of faults or malfunctions, switch off the equipment and do not attempt to repair it by
yourself as doing so may void the warranty. All service and repair operations must be
performed exclusively by a manufacture’s authorized engineer. (Authorized service
technician, trained service personnel, authorized service personnel)
This unit, like any other appliance, must have access to fresh air/oxygen;
Do not use FLAME to check for gas leak.
Do not under any circumstances try to modify or repair valves, regulator, connectors,
controls or any other appliance. Doing so creates the risk of a gas leak.
1.6 CUSTOMER’S RESPONSIBILITIES
The customer is required to:
Execute the electrical connection of the equipment. Prepare the place of installation;
Provide consumable materials for cleaning Perform routine maintenance;
In the case of power failures or malfunctions do not open the doors, in order to maintain
the internal temperature for as long as possible. If the problem persists for more than a
few hours, move the contents to a more suitable place.
1.7 CUSTOMER SERVICE REQUESTS
For all technical problems and any requests for technical service, refer exclusively to the
manufacturer’s authorized personnel;

STANDARDS AND GENERAL WARNINGS
11
1.8 ORDERING OF SPARE PARTS
Orders of spare parts should be made by consulting the part reference code and the serial
number of your unit. Consult your dealer.
1.9 PRODUCT CONFIGURATION
The unit is designed solely for the preservation of laboratory products, which requires
various controls and warning in case of sudden alteration of temperature.
PRODUCTS MUST BE STORED IN ORDER TO ENSURE EFFICIENT AIR
CIRCULATION INSIDE THE UNIT AND SHALL NOT COME OUT OF THE
SHELF/DRAWER PERIMETER.
All uses outside of manufacturer’s intended use in section 1.1 shall be construed as
“improper use” for which the manufacturer declines all responsibility.
It’s allowed to accommodate on the shelf a maximum of 20kg per shelf in according to the
UL471 regulation. [The most critical application in terms of weight (glass door/ stainless
steel) has been tested following the Base standard UL 61010-1.The application can contain
a maximum of 15 shelve.
1.10 MATERIALS AND REFRIGERANTS
Materials in contact or potentially in contact with products are in compliance with the
relevant directives. The equipments designed and built so that contact parts can be cleaned
before each use. The refrigerants utilized comply with established regulations.
1.11 WARNING LABELS
Electrical Shock LABEL A
Use of this equipment involves power supplies which convert line
voltage to low voltage power. Do not modify or use power supplies
other than OEM equipment. Connection of the power supply may
require a properly grounded receptacle. Potential for electrical
shock or equipment damage exists if precautions are not followed.
Hot Surface LABEL B
Avoid contact with the hot surfaces potential for skin’s burns.
Cold Surface LABEL C
Avoid contact with cold freezer surfaces potential for cold burns or
skin sticking to cold surfaces.
Safety Alert LABEL D

STANDARDS AND GENERAL WARNINGS
12
Important operating instructions. To reduce the risk of injury or poor
performance of the unit read the user manual before putting the
equipment into operation .
Warning
Indicates an immediately hazardous situation, which if not avoided,
will result in death or serious injury .

STANDARDS AND GENERAL WARNINGS
13
Caution
Indicates an immediately hazardous situation, which if not avoided,
may result in minor to moderate injury
Battery LABEL E
Indicates the location of the back-up battery
Grounding LABEL G
Indicates that the electrical components are electrically grounded.
Finger crashing
Risk of finger crashing
Refrigerating Equipment intended for
laboratory use.

1.12 FDA LABELS
Manufacturer
Manufacture Date
Keep Dry
Don’t Use if the Package is Brocken
Not Sterile
Attention
STANDARDS AND GENERAL WARNINGS
It indicates the generality of the manufacturer of the medical
Device.
Indicated the
the day of manufacture of the medical device
Keep the medical device dry.
Don’t Use if the Package is Brocken
Don’t use if the package of the medical Device is broken of
Opened.
This Medical Device has not
undergone a sterilization process
Read The instructions before the use of the Medical Device.
STANDARDS AND GENERAL WARNINGS
14
It indicates the generality of the manufacturer of the medical
the day of manufacture of the medical device
Don’t use if the package of the medical Device is broken of
undergone a sterilization process
.
Read The instructions before the use of the Medical Device.

Upper temperature limit
Upper and lower humidity
limit
Catalog number
Lot Number
Serial Number
STANDARDS AND GENERAL WARNINGS
The maximum environmental temperature to grant the safe use of
the medical device is 32°C.
limit
s
The maximum environmental humidity to grant the safe use of the
medical device is 70% while the lower one is 10%..
It indicate the model of the Medical Device.
Is the identifier of the production batch.
Is the manufacturer internal code. It consent to identify a specific
Medical Device.
STANDARDS AND GENERAL WARNINGS
15
The maximum environmental temperature to grant the safe use of
The maximum environmental humidity to grant the safe use of the
medical device is 70% while the lower one is 10%..
It indicate the model of the Medical Device.
Is the manufacturer internal code. It consent to identify a specific

16
2. INSTALLATION
2.1 TRANSPORTATION AND HANDLING
The equipment must be transported and handled exclusively in upright position, in
observance of the instructions printed on the packing.
This precaution is necessary to avoid contamination of the refrigerant circuit with compressor lube
oil with resulting valve and heat exchanger coil failure and problems starting the electric motor or
the risk of a gas leak. The manufacturer is not responsible for any problems due to transport
executed in conditions other than those specified herewith.
The equipment is secured to a wooden pallet base, wrapped in a plastic film and packaged into a
three waves carton box..
The equipment must be handled using a fork lift truck or a pallet truck with suitable forks (fork
length at least equal to 2/3 length of unit).
2.2 POSITIONING
Incorrect positioning can cause damage to the equipment and generate hazardous conditions for
personnel. The installer must therefore observe the following general regulations:
Make sure you maintain a minimum of 11 13 16 inches (30 cm). clearance from the back wall,
19 43 54
” (50 cm) from the side walls and the ceiling. The room must be well ventilated.
Keep well away from sources of heat. Avoid direct sunlight exposure.
Remove packing material.
Remove accessories from inside the unit.

STANDARDS AND GENERAL WARNINGS
17
Cartoon box or Wood base removal: using a hammer, tilt the cabinet to one side and loosen
the two thread-forming screws, drag the cabinet from the back side holding the base still until
the four castors have gone out from the containing holes, slightly tilt the cabinet backward and
take the base away pulling it from the front side.
Use gloves when handling the 3 Waves cartoon box or the wooden base to protect the hands
from splinters.
Position the equipment with the help of a level. Remove the protective PVC film from the
external surfaces of the unit.
2.3 WIRING AND ELECTRICAL HOOK-UP
Receptacle installation and electrical wiring operations must be performed by a qualified
electrician. For safety reasons adhere to the following indications:
Check that the electrical plant is suitably sized for the absorbed power of the unit.
If the electrical socket and the plug on the equipment power cord are incompatible,
call technical service or your local distributor.
Do not use reductions or multi-way adapters (Fig.1)
It is important to connect the equipment correctly to an efficient earth system
executed in compliance with the relevant legislation.
A switch or circuit-breaker must be included in the installation:
it must be suitably located and easily reached;
it must be marked as the disconnecting device for the equipment.
The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in residential environment for which
CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
The Plasma Freezer is a Medical Equipment that meets the requirement of CISPR 11 Class A
appliances: this means that they are predominantly intended to be connected (e.g. in
hospitals or doctor's offices) to dedicated supply systems (normally fed by separations
transformer)
2.4 SET UP OPERATIONS
To avoid errors and accidents, perform a series of checks for possible damage sustained during
transport, installation and hook-up operations before starting up the unit.
PRELIMINARY CHECKS
Check the condition of the power cord (no cut or chaffing). Check that the door hinges and
shelf support are stable.
Check the door seals and shelves are not damaged (broken or scratched) and that the door
closes and seals properly.
Make sure all copper tubing, unions are in perfect condition.
FOR OPTIMAL PERFORMANCE
Do not block the motor compartment air vents. Do not lay objects on the top of the equipment
Before storing products wait until they are cold.

STANDARDS AND GENERAL WARNINGS
18
Arrange the products on suitable shelves or in containers. Do not place products directly on
the base or against the walls, doors or fixed guards of the unit.
Make sure doors are kept closed.
Keep the defrost water drain outlet clear.
Limit the frequency and duration of opening; each time the door is opened the internal
temperature will alter.
Load products at ambient temperature gradually to allow correct refrigeration. Perform routine
maintenance regularly.
2.5 RE- INSTALLATION
Observe the following procedure:
Switch off the equipment from the main switch.
Disconnect the power cord from the electrical outlet.
Handle the equipment in accordance with the instructions in Section 2.1.
Follow the instructions in Section 2.2 for positioning and hook-ups in the new location.
2.6 SCRAPPING AND DISPOSAL
These units may contain materials, which at the end of the working life of the apparatus, must be
disposed at one of the recycling centers nominated by your Local National Health Department or
as specified by the law in force. Scrapping and disposal of the equipment must be carried out in full
observance of established legislation in your country.
In particular, the apparatus may contain the following materials:
Iron
Copper
Aluminium
Non-biodegradable plastics
Fibre glass for printed circuits
Ferrite
Batteries
CFC-free refrigeration gas
Electrical and electronic equipment (WEEE)
The manufacturer shall not be chargeable for any disposal of the apparatus at the end of its
working life.
In line with EU Directive 2002/96/EC for waste electrical and electronic
equipment (WEEE), this electrical product must not be disposed of as
unsorted municipal waste. Please dispose of this product by returning it to
your local municipal collection point for recycling.
2.7 REMOTE ALARM CONNECTION
These units are equipped with a remote alarm plug for the
connection to a remote alarm network.
The remote alarm plug is installed at the back of the cabinet near the
electrical box enclosure and it is wired through a connection cable to
the controller board.

STANDARDS AND GENERAL WARNINGS
19
The Remote alarm contact is a Dry contact (low voltage: max 24VAc/VDc, 1A, SELV) and
consist of three outputs: C (Common)/N.O. (Normally Opened Circuit) / N.C. (Normally Closed
Circuit). For the external network connection, fasten directly the pins according with the remote
alarm network configuration. When an alarm occurs the contact relay switches from the N.C.
position to N.O.
3. OPERATION
Before switching ON the unit, check that the electrical connections have been made correctly and
above all, that the ground connection is available and working properly.
Please read before using this manual
- This manual is part of the product and should be kept near the instrument for easy and quick
reference.
- Digital controller with defrost and fans management shall not be used for purpose different
from those described hereunder. It cannot be used as a safely device.
- Check the application limits before proceeding.
Safety precautions
- Check the supply voltage is correct before connecting the instrument.
- Do not expose to water or moisture: use the controller only within the operating limits avoiding
the temperature changes with high atmospheric humidity to prevent formation of
condensation.
Warning
- Disconnect all the electrical connections before any kind of maintenance.
- In case of failure or faulty operation contact technical service or Dealer.
- Consider the maximum current which can be applied to each relay.
- Ensure that the wired for probes, loads and the power supply are separated and far enough
from each other, without crossing or intertwining.
3.1 STARTING CYCLE
Plug in the unit, the controller will start to load the software then it will put the screen into the Home
page view.
From the Home Page screen touch the START CYCLE mark button:
The cycle settings menu view will then appear on the screen:

OPERATION
20
Touch the “CYCLE TYPE” tab to select a cycle either by time or by product temperature core probe:
In order to modify the cycle options, press into the tab of the option that need to be adjusted . The
tab will light green then dial the value using the keyboard on the right side of the screen. Once set
up the correct value, press the OK button.
By factory default, the AIR TEMP. is -40°C, the fan speed is 10 and the storage temperature is
-40°C.
Once set up the cycle options touch the START button to start up the cycle: the controller will start
to load the program and a message will be displayed on the screen:

OPERATION
21
Once the cycle starts, the screen will show the cycle main view: a graph shows in real time the
temperatures detected by the four cores of the product probe as well as the cavity temperature:
On the right side of the screen instead the hottest core probe value, the cavity temperature, the
counting time from the start of the cycle, the end cycle temperature set point, the cavity temperature
set point, the cycle time set point and the fan speed are displayed.
Once the cycle is completed, a flag icon will appear on the screen and a buzzer will alert that the
cycle ended. The unit switches automatically into storage mode.
If you want to interrupt an ongoing cycle, press the STOP CYCLE red button. The screen will return
to the Home page.
3.1.1 Time Cycle
During a Time Cycle (clock icon in the CYCLE TYPE tab) the unit will run the
cycle pulling down and holding the temperature inside the cavity at the desired
temperature set in the “AIR TEMP.” tab, for the desired target time set in the
“CYCLE TIME” tab.
Once the CYCLE TIME is elapsed, a checkered flag will appear on the screen
and a buzzer will start to sound alarming that the cycle ended.
At the end of the cycle, the unit will switch automatically into the STORAGE
mode, adjusting and holding the temperature set in the T.STORAGE tab until the unit is not
stopped manually by touching the stop button on the screen.
3.1.2 Product temperature Cycle
During a Temperature cycle (Needle probe icon in the CYCLE TYPE tab), the
multi-core needle probes of the unit must be inserted inside a simulation bag.
The Unit will run the cycle pulling down and holding the temperature inside the
cavity at the desired temperature set in the “AIR TEMP.” tab until the 4 cores of
the needle probe reads the target temperature set in the “CYCLE TEMP.” tab.
Once the multi-cores needle probe hits the target temperature, a checkered
flag will appear on the screen and a buzzer will start to sound alarming that the
cycle ended.
At the end of the cycle, the unit will switch automatically into the STORAGE mode, adjusting and
holding the temperature set in the T.STORAGE tab until the unit is not stopped manually by
touching the stop button on the screen.

OPERATION
22
Note: in case the temperature measured by the needle probe is lower than the target
temperature, the cycle won’t start and a message will appear on the screen saying “Start
Cycle failed!”
3.2 USER MENU
From the HOME PAGE screen, touch the USER icon :
The screen then will display the USER menu that includes the Date&Time settings menu, the
Language set up menu, the USB options menu, LAN network settings menu, I/O STATUS menu
and the Manual Defrost start cycle.
3.2.1 USB option
Through the USB port, located on the right side of the Touch Screen frame, it’s possible both to
import and export data from/to a USB stick. There are no special requirement for the type of USB,
however an empty formatted USB with minimum 2 gigs is recommended.
In the USER MENU screen, touch the USB mark tab then you will be put into the USB options view: