Thermo Scientific CW3 Instruction Manual

Thermo Scientific CW3 Cell Washer
Instruction Manual
50144259_h 06 / 2018
Visit us online to register your warranty:
www.thermofisher.com/labwarranty
1. Preface ............................................................... 5
1. 1. Items Supplied .............................................................5
1. 2. Intended Use ...............................................................7
1. 3. Precautions ................................................................7
1. 4. Symbols Used on the Cell Washer .............................................10
1. 5. Symbols Used in the Manual .................................................11
2. Technical Specifications ................................................12
2. 1. Directives and Standards ....................................................13
2. 2. Mains Supply .............................................................13
2. 3. Location and Function of Parts ................................................14
2. 4. Control Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2. 5. Condition-setting Panel .....................................................18
3. Transport and Set Up ...................................................20
3. 1. Before Setting Up ..........................................................20
3. 2. Location .................................................................20
3. 3. Transporting ..............................................................20
3. 4. Leveling ..................................................................21
3. 5. Check Mains Connection ....................................................21
3. 6. Setting Up ................................................................21
3. 7. Storage ..................................................................32
3. 8. Shipping .................................................................32
4. Operation ............................................................ 33
4. 1. Preparation ...............................................................33
4. 1. 1. Injection Volume Adjustment and Pump Ventilation ..........................................33
4. 1. 2. Setting the Operating Conditions .......................................................35
4. 1. 3. Preparation of the Sample ............................................................35
4. 2. Operation Modes ...........................................................36
Thermo Scientic CW3 | 3
4. 2. 1. Automatic Mode ...................................................................36
4. 2. 2. Manual Mode .....................................................................36
4. 2. 3. Agitation-Centrifugation ..............................................................36
4. 2. 4. Operational Sequence for Antiglobulin Test ................................................37
5. Maintenance .......................................................... 38
5. 1. Cleaning .................................................................38
5. 1. 1. Pump, Tank and Tubing ..............................................................39
5. 1. 2. Rotor, Distributor and Bowl ...........................................................39
5. 1. 3. Chamber, Splash Guard, Drain Cover and Door Stopper Parts ..................................40
5. 2. Preventive Maintenance .....................................................41
5. 3. Shipping and Disposal ......................................................41
6. Troubleshooting ....................................................... 42
6. 1. Mechanical Emergency Door Release ..........................................42
6. 2. Error Codes ...............................................................43
6. 3. Troublshooting when no Error Code is indicated ..................................44
Decontamination Information Certificate ..................................... 45
Chemical Compatibility ................................................... 46
Index ..................................................................49
4 | CW3 Thermo Scientic

1. Preface

1. 1. Items Supplied

Article No. Description Quantity
Thermo Scientific CW3 cell washer 1
S402776A Bowl Assembly 1
S413259C Tank (5 L) 1
4744346 Tubing 3 m
75000015 Tube Connector 1
S4011034 Drain Tube 2.5 m
Items Supplied
480270
483719 Grease 1
8046004 Hex. Wrench 1
S411107 Motor Guard Plate 1
4666354
4666357
4666355
S413181A L-shaped Adapter 1
480879 D10 Adapter 25
Rotor Assembly Options 1
75000020 24 place rotor assembly with distributor
75000021 12 place rotor assembly with distributor
Test Tubes (12 mm in diameter and 75 mm in length)
Hose Band
Small
Medium
Big
Power Cord 1
Instruction Manual 1
50 (1 box)
1
1
2
 
Thermo Scientic CW3 | 5
Items Supplied
Article No. Description Quantity
Replacement Parts
Rotor Assembly 1
75000022 24 places
75000023 12 places
Distributor Assembly 1
75000024 24 places
75000025 12 places
6 | CW3 Thermo Scientic

1. 2. Intended Use

The Thermo Scientific CW3 cell washer is designed to perform cell washing in multiple washing cycles using saline solution. The cell washer provides blood cells after sample separation, which can be used for further blood testing such as Antiglobulin test, ABO compatibility, Rh testing, Cross-matching and Antibody screening.
The centrifuge should always be operated by a trained individual such as a clinical laboratory technologist or a person with a similar education.

1. 3. Precautions

Carefully read the following safety precautions for a thorough understanding.
Protection is impaired if the cell washer is not used as specified in the intended use.
Follow the instructions and procedures described in this instruction manual to operate this cell washer safely.
Be sure to observe the precautions in this instruction manual and on your equipment.
It is the general obligation of the operator to make sure, that the proper protective clothing is used. Mind the „Laboratory Biosafety Manual“ of the World Health Organization (WHO) and the regulations in your country.
Safety messages are indicated as follows. They are stated with signal words combined with the safety alert symbol to call your attention to items or operations that could be dangerous to you or other persons using this equipment. The definitions of signal words are as follows:
WARNING: Warning notes indicate any condition or practice, which if not strictly observed, could result in seri-
ous injury or possible death.
CAUTION: Caution notes indicate any condition or practice, which if not strictly observed or stopped, could
result in personal injury, damage or destruction of the equipment.
NOTICE: Notes indicate an area or subject of special merit, emphasizing either the product’s capabilities or
common errors in operation or maintenance.
Do not operate this cell washer in any manner not described in this Instruction Manual. Should you have any troubles with this cell washer, call a Thermo Fisher Scientific authorized sales/service representative.
The precautions described in this Instruction Manual are carefully developed to cover all possible risks. It is important that you are alert for unexpected incidents. Be careful when operating this cell washer.
Intended Use
Thermo Scientic CW3 | 7
Precautions
WARNING
1. The cell washer is neither inert nor protected against explosion. Never use the cell washer in an explosion-prone environment.
2. Do not set up the cell washer in or near places where flammable gases are generated or chemicals are stored.
3. If centrifuging any hazardous materials mind the „Laboratory Biosafety Manual“ of the World Health Organization (WHO). Look on the internet page of the World Health Organization (www.who.int) for the „Laboratory Biosafety Manual“. For materials in a higher risk group, extra safety measures have to be taken.
4. Take all necessary safety measures before using samples that are toxic or radioactive, or blood samples that are pathogenic or infectious. You use such samples at your own responsibility.
a. If the cell washer, rotor, or an accessory is contaminated by samples that are toxic or radioactive, or blood
samples that are pathogenic or infectious, be sure to decontaminate the item according to good laboratory procedures and methods.
b. If there is a possibility that the cell washer, rotor, or an accessory is contaminated by samples that might
impair human health (for example, samples that are toxic or radioactive, or blood samples that are pathogenic or infectious), it is your responsibility to sterilize or decontaminate the cell washer, rotor, or the accessory properly before requesting repairs from a Thermo Fisher Scientific authorized sales/service representative.
c. It is your responsibility to sterilize and/or decontaminate the cell washer, rotor, or parts properly before
returning them to a Thermo Fisher Scientific authorized sales/service representative.
5. Do not centrifuge explosive or flammable materials or substances which could react violently
6. Because the liquid samples, the saline, etc. are used in this cell washer, your cell washer must be grounded properly.
7. To avoid electrical shocks, do not handle the power cord or turn on or off the POWER switch with wet hands.
8. The cell washer itself may move if the rotor fails during high-speed rotation. Make sure there is a 30 cm area around the cell washer that will allow for such movement and do not allow individuals to enter into that area during operation. Also do not place dangerous objects such as flammable or explosive materials on top of the cell washer or in the surrounding area.
9. While the rotor spins, never unlock the door.
10. Repairs, disassembly, and other modifications to the cell washer are strictly prohibited unless performed by a Thermo Fisher Scientific authorized sales/service representative.
8 | CW3 Thermo Scientic
CAUTION
1. Turn off the cell washer at the main switch. The mains plug must be freely accessible at all times. Press STOP to shut the cell washer down. Pull out the power supply plug or disconnect the power supply in an emergency.
2. Use the cell washer only with correct installed rotor and distributor assembly and correct inserted bowl, splash guard and drain cover.
3. Do not move or relocate the cell washer while the rotor spins.
4. Do not lean on the cell washer.
5. Do not pour any solution such as water, detergent, or disinfectant directly into the rotor chamber. If you do so, the bearings of the drive unit might corrode or deteriorate.
6. Connect the saline tank to the pump inlet connector of the cell washer correctly with the hose bands (standard accessories). Otherwise the liquid might leak from the tube and the liquid might get into the inside of the cell washer. If you think liquid is inside of the cell washer, contact a Thermo Fisher Scientific authorized sales/service representative to clean and dry the cell washer.
7. Before you operate the cell washer, remove any dropped objects and tube fragments from inside the rotor chamber.
8. Always check for corrosion and damage on the rotor before using it. Do not use a corroded or damaged rotor.
9. Be sure to use the specified test tubes with a wall thickness of 1 mm or more. When using thin test tubes such as disposable test tubes, do not use them repeatedly. If any scratches, crack, inside warp, etc. is found on the test tubes, do not use them because they cannot bear a centrifugal force.
10. Be sure to load test tubes to all the holders.
11. Use one or two drops (about 50 μl) of 3-5% erythrocyte suspension as sample volume for blood cell washing. When using precipitated erythrocyte layer, use one or two drops (about 50 μl or less) per test tube. Use the 80% or less of the test tube capacity as sample volume for centrifugation.
12. If you observe some abnormality in this product, stop using it immediately and contact a Thermo Fisher Scientific authorized sales/service representative. Notify the service representative of the alarm code if displayed.
13. If the cell washer will not be used for a long time, remove the power cord from the socket.
14. For connection to a different outlet, the power cord might be needed to be replaced.
15. Follow local electrical codes.
16. Depending on the magnitude, an earthquake might damage the cell washer. If you observe some abnormality, contact a Thermo Fisher Scientific authorized sales/service representative.
Precautions
NOTICE
Usually the control panel and the surface of the cell washer get warm during operation.
Thermo Scientic CW3 | 9
Symbols Used on the Cell Washer

1. 4. Symbols Used on the Cell Washer

This symbol refers to general hazards.
CAUTION means that material damage could occur.
WARNING means that injuries or material damage or contamination could occur.
This symbol refers to biological hazards.
Observe the information contained in the instruction manual to keep yourself and your environment safe.
This symbol refers to information on hazards, described within the manual.
This symbol demands to disconnect mains before transporting or servicing the cell washer.
This symbol demands to not pour the open cell washer with water.
This symbol shows the inflow and draining directions of the cell washer. The arrow pointing towards the cell washer shows the inflow direction. The arrow pointing away from the cell washer shows the draining direction.
This symbol demands to make sure, that the drain cover is installed in the cell washer door before you start the CW3 cell washer. If not, biological hazard is possible when contaminated samples are used.
See “5. 1. 4. 4. Drain Cover” on page 40 for removing and installation.
Caution: Federal law restricts this device to sale by or on the order with a qualified clinical facility manager or equivalent.
10 | CW3 Thermo Scientic
The CE mark states that this product is meeting all requirements for the European Economic Area.
This CSA mark states that this product is meeting all requirements for Canada and USA.
This symbol marks the manufacturer of this product.
Symbols Used in the Manual
This symbol marks the manufacturing date of this product.
This symbol marks the catalogue number of this product.
This symbol marks this product as intended to be used as an in vitro diagnostic medical device.

1. 5. Symbols Used in the Manual

This symbol refers to general hazards.
CAUTION means that material damage could occur.
WARNING means that injuries or material damage or contamination could occur.
This symbol refers to biological hazards.
Observe the information contained in the instruction manual to keep yourself and your environment safe.
Thermo Scientic CW3 | 11
Symbols Used in the Manual
2. Technical Specifications
Environmental Conditions Altitudes of up to 2000 m above sea level
Environmental Conditions during Storage and Shipping
Permissible Ambient Temperature during Operation
Average Heat Dissipation 54 Wh / 184 Btu/h / 194 kJ/h
Overvoltage Category II
Pollution Degree 2
IP 20
Running Time Automatic: 1 – 99 sec / manual: 1 – 999 sec
Max. relative humidity 80% up to 31°C; decreasing linearly up to 50% relative humidity at 40°C
Temperature: -10 °C to +55 °C
Humidity: 15% to 85%
+2 °C to +35 °C
Maximum Speed² n
Minimum Speed³ n
Maximum RCF-Value at n
max
min
max
Noise Level at Maximum Speed
¹
3000 rpm
330 rpm
1180 x g
< 53 dB (A)
Maximum Kinetic Energy 0.46 kJ
Dimensions
Height (open door / closed door) 630 mm / 410 mm
Width
Depth
²
Weight
1
Front Side Measurement, 1 m in fr ont of the instrument at 1.6 m height. 3 washing-cycles each with about 35 s centrifugation.
2
Mode manual centrifuge
2
Mode manual decant
370 mm
450 mm
28 kg
12 | CW3 Thermo Scientic

2. 1. Directives and Standards

Region Directive Standard
Europe
220-230 V, 50/60 Hz
USA & Canada
120 V, 60 Hz
China
220-230 V, 50/60 Hz
98/79/EC In Vitro Diagnostic Medical Devices (IVD)
2014/35/EU Low Voltage (protective goals)
2006/42/EC Machinery (protective goals)
2014/30/EC Electromagnetic Compatibility
(EMC) (protective goals)
2011/65/EC RoHS – Directive on the Restriction of the use of certain Hazardous Substances in electrical and electronic equipment
FDA – 510(k) cleared
Regulation Name: Automated Cell-Washing Centrifuge for Immunohematology
Regulatory Class: 2
Product Code: KSN
EN 61010-1
EN 61010-2-020
IEC 61010-2-101
EN 61326-1 Class B
EN ISO 13485
CAN/CSA-C22.2 No. 61010-1-04
UL Std. No. 61010-1
CAN/CSA-C22.2 No. 61010-2-020-09- Part 2-020
IEC 61010-2-020
IEC 61010-2-101
IEC 61010-1
IEC 61010-2-020
IEC 61010-2-101
EN 61326-1 Class B
Directives and Standards

2. 2. Mains Supply

The following table contains an overview of the electrical connection data. This data is to be taken into consideration, when selecting the mains connection socket.
Unit Thermo Scientific CW3 cell washer
Article No. 75007404 75007405
Mains Voltage 120 V 220-30 V
Frequency 60 Hz 50 / 60 Hz
Rated Current 2.7 A 1.5 A
Power Consumption 135 W 135 W
Equipment Fuse 10 AT 10 AT
Building Fuse 15 AT 16 AT
Thermo Scientic CW3 | 13
Location and Function of Parts

2. 3. Location and Function of Parts

Front view
1
11
2
3
10
4
9
5
8
7
6
No. Part Description
1 Nozzle Through this nozzle, saline is supplied from the pump to the distributor.
2 Drain cover Receives the waste liquid decanted from the rotor and discharges it to the outside.
3 Distributor Distributes the saline supplied from the pump to each test tube held on the rotor.
4 Rotor A 12 or 24-sample rotor.
5 Splash guard Designed to keep saline, waste liquid, etc. from leaking to the internal mechanism of the
cell washer. Removable.
6 Condition-setting panel See “2. 5. Condition-setting Panel” on page 18.
7 POWER switch Switches on and o the cell washer power. It doubles as a circuit protector. It
automatically switches o the cell washer power if abnormal current passes.
8 Control panel See “2. 4. Control Panel” on page 17.
9 Door lock lever Keeps the door locked while the rotor is running.
10 Bowl Rotates together with the rotor. It determines the angle to which the test-tube holders of
the rotor swing.
11 Door Test tubes are set on the rotor after opening the door. The drain cover and nozzle are
installed on the back of the door.
14 | CW3 Thermo Scientic
Rear view
1
3
Location and Function of Parts
8
7
6
2
5
4
No. Part Description
1 View port You can measure the rotor speed through the view port by an optical reflection type
rotation meter.
2 Drain connector The overflowed waste liquid is drained through this connector.
3 Power connector To be connected to a power supply.
4 Sensor connector To be connected to the sensor which detects the level of saline in the tank.
5 Auxiliary drain tube The chamber is drained through this tube if the drain connector is blocked.
6 Pump Provided for supplying saline into the cell washer.
7 Pump inlet connector To be connected to the saline tank by tubing.
8 Door stopper parts Designed to keep the open angle (60°) of the door to prevent the door to be wide-open.
Thermo Scientic CW3 | 15
Loading...
+ 36 hidden pages