Beckman Coulter S120 Instructions For Use Manual

Instructions for Use

StatSpin CritSpin Digital Reader Model Number S120

For In Vitro Diagnostic Use

This manual is intended for

CSD2 Digital Reader -with tube adapter for 75mm tubes, and with a universal power
supply.

Printed in U.S.A.

55-003823-001CC
September 2018

Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Instructions for Use
StatSpin CritSpin Digital Reader Model Number S120

PN 55-003823-001CC (September 2018)

©

2018 Beckman Coulter, Inc.

All Rights Reserved.

Trademarks

Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned
herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other
countries.

All other trademarks are the property of their respective owners.

Find us on the World Wide Web at:

www.beckmancoulter.com

Rx Only
Original Instructions

Revision History

55-003823-001 CC, 09/2018

• Moved: Symbol/Regulatory Mark and a link to the website in the California
Proposition 65 statement

55-003823-001 CB, 03/2018

• Converted the CritSpin Digital Reader Operations Manual to a Beckman Coulter
Instructions for Use (IFU) Manual, and made general clarification to the IFU

• Added: Revision History, Safety Notice, Symbols and Definitions table, Alerts for
Warning, Caution, Important, Note, and Tip explanations, and Warning and Cautions

• Updated: Logo, Manufacturer address, and Limited Warranty statement

• Deleted: EC Rep

55-003823-001CC

iii

Revision History

iv 55-003823-001CC

Read all product manuals and consult with Beckman Coulter-trained personnel before you
operate the system. Do not perform any procedure before you carefully read all
instructions. Always follow the product labels and the manufacturer’s recommendations. If
you have any questions:

• Visit http://www.beckmancoulter.com.

• US customers: Contact Beckman Coulter Customer Support at 1-800-854-3633.

• International customers: Contact your local distributor.

Alerts for Warning, Caution, Important, Note, and Tip

Warning

Warning indicates a potentially hazardous situation which, if not avoided, could
cause death or serious injury. Warning can indicate the possibility of erroneous data
that could cause an incorrect diagnosis.

Safety Notice

Caution

Caution indicates a potentially hazardous situation which, if not avoided, can cause
minor or moderate injury. Caution can also alert against unsafe practices, or indicate
the possibility of erroneous data that could cause an incorrect diagnosis.

Important

Important indicates important information to follow.

Note

Note indicates notable information to follow.

Tip

Tip indicates information to consider.

Warning and Cautions

Pay close attention to the instructions that accompany the notes and symbols and the
standard laboratory procedures outlined by your facility and local regulatory agencies.

55-003823-001CC

v

Safety Notice

Warning and Cautions

Warning

Perform system operations with caution.

Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and lab coats.

Wash hands thoroughly after contact with sample media and all maintenance
activities.

Observe all laboratory policies and procedures related to the handling of
biohazardous materials.

Refer to the applicable sources (such as Material Safety Data Sheets) for specific
hazard information.

Warning

If the equipment is used in a manner not specified by Beckman Coulter, the
protection provided by the equipment may be impaired.

Warning

Outside of North America: do not use the power cord supplied. Use power cord for at
least 1.0 Amp with an IEC320/CEE22 female connector and male connector suitable
for the power outlet to be used.

Warning

Electromagnetic Wave and Noise

The system generates, uses, and can radiate radio frequency energy. If the system is
not installed and operated correctly, this energy can cause interference with other
equipment. In addition, other equipment can radiate radio frequency energy to
which the system is sensitive. If you suspect interference between the system and
other equipment, Beckman Coulter recommends the following actions to correct the
interference:

This equipment complies with the emission and immunity requirements described in this

•

part of the EN/IEC 61326 -1
As to emission, this system has been designed and tested to CISPR 11 Class A, so in a

•

domestic environment, it may cause radio interference, in which case, you may need to
take measure to mitigate the interference.

It is recommended to evaluate the electromagnetic environment prior to operations of

•

the system.
Do not use this system in close proximity to sources of strong electromagnetic radiation

•

(for example, unshielded intentional RF sources). As they can interfere with the proper
operation.

vi 55-003823-001CC

Do not use mobile or cordless telephones and transceivers in the same room as the

•

system.
Do not use medical equipment that can be susceptible to malfunctions caused by Electric

•

Magnetic Field (EMF) near the system.

Please use the instrument as intended. Improper use may cause damage to the instrument,
inaccurate results, or potentially nullify warranties.

Symbols and Definitions

CritSpin Symbols GlossaryTable 1

Symbol Description

Safety Notice

Symbols and Definitions

Consult instructions for use

Indicates the need for the user to consult the instructions for use.

ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.4.3

Caution

Indicates the need for the user to consult the instructions for use for
important cautionary information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the medical device itself.

ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.4.4

Direct current

To indicate on the rating plate that the equipment is suitable for direct
current only; to identify relevant terminals.

IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5031

Manufacturer

Indicates the medical device manufacturer as defined in EU Directives
90/385/ EEC, 93/42/EEC and 98/79/EC.

ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.1.1

Supplemental Product-Specific Manufacturer Information

This symbol identifies who the legal manufacturer of the product is.

55-003823-001CC vii

Safety Notice

Symbols and Definitions

Table 1

CritSpin Symbols Glossary (Continued)

Symbol Description

Date of Manufacture

To indicate the date when the medical device was manufactured.

ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.1.3

In vitro diagnostic medical device

Indicates a medical device that is intended to be used as an in vitro
diagnostic medical device.

ISO 15223-1: Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General requirements,
clause 5.5.1

Catalogue Number

Indicates the manufacturer's catalogue number so that the medical device
can be identified.

ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.1.4

Serial number

Indicates the manufacturer's serial number so that a specific medical
device can be identified.

ISO 15223-1. Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
Requirements. #5.1.7

Country of Origin Symbol

This symbol indicates the country that the product was manufactured.

Polarity of d.c. power connector

To identify the positive and negative connections (the polarity) of a d.c.
power supply, or the positive and negative connections on a piece of
equipment to which a d.c. power supply may be connected.

IEC 60417: Graphical symbols for use on equipment - Overview and
application, #5926

viii 55-003823-001CC

Safety Notice

Symbols and Definitions

Table 1

CritSpin Symbols Glossary (Continued)

Symbol Description

Warning; Biological hazard

To warn of a biological hazard.

IEC 60878. Graphical Symbols for electrical equipment in medical practices.
#7010-W009

Supplemental Product-Specific Manufacturer Information

This label indicates a caution to operate only with all covers in position to
decrease risk of personal injury or biohazard.

This label indicates the use of biohazardous materials in the area. Use
caution when working with possible infectious samples.

Wear Personal Protective Equipment (PPE) such as gloves, eye shields, and
lab coats. Handle and dispose of biohazardous materials according to your
laboratory procedures.

California Proposition 65

This product can expose you to chemicals known to the State of California
to cause Cancer and Reproductive Harm. For more information go to

https://www.P65Warnings.ca.gov.

55-003823-001CC ix

Safety Notice

Symbols and Definitions

x 55-003823-001CC

Revision History , iii

Safety Notice, v

CHAPTER 1: System Overview, 1-1

Intended Use, 1-1

Description, 1-1

CHAPTER 2: Operating Instructions, 2-1

Operation, 2-1

Read Spun Hematocrit Tubes inside Rotor, 2-1

Use 75 mm Adapter, 2-3

Readout Setting, 2-3

Cleaning, 2-4

Troubleshooting and Maintenance, 2-4

APPENDIX A: Specifications, A-1

Specifications , A-1

Accessories List, A-1

Contents

APPENDIX B: References, B-1

References, B-1

55-003823-001CC

xi

Contents

xii 55-003823-001CC

Intended Use

The StatSpin CritSpin Digital Reader assists the operator in measuring spun hematocrits
from the StatSpin Centrifuges. A tube adapter is also provided to measure spun hematocrits
in 75 mm tubes from other hematocrit centrifuges.

For in vitro diagnostic use.

Description

The CritSpin Digital Reader operates from the switching power supply (PN
X01-003553-001) provided with the digital reader. Plug the power supply into the digital
reader (Digital Reader (PN CSD2).)

CHAPTER 1

System Overview

Important

Use only the AC Power Adapter supplied with the digital reader. Use of another power
supply will damage the Reader and void the warranty.

Figure 1.1

Reader Configuration Product No.: CSD2

55-003823-001CC

1-1

System Overview

Description

1-2 55-003823-001CC

Operation

To use this digital reader, hematocrit tubes are filled with blood, sealed and centrifuged in
the RH12 hematocrit rotor. The procedure and step-by-step drawings for filling hematocrit
tubes can be found in your centrifuge Instructions for Use manual. Normal values are
located in your Instructions for Use manual, read the manual before performing a
hematocrit. Follow laboratory procedures when performing any procedure on body fluids.
When tubes are centrifuged, the hematocrit rotor is removed from the centrifuge and
placed into the digital reader.

Read Spun Hematocrit Tubes inside Rotor

The digital reader has a tilt bar on the underside. Use the tilt bar to provide a tilted position
from which to read tubes. You can use either position for reading.

1

Install the rotor in the digital reader:

a. Move the pointer all the way to the right.

CHAPTER 2

Operating Instructions

Tip

To move the pointer, gently press it down to allow a smooth gliding motion.

b. Place the rotor in the center of the digital reader.

2

Turn the rotor so that the first tube to be read is at the 3-o’clock position.

3

To initiate the first reading, press Set.
The LED next to the label Move pointer to bottom of cells. Set "0" flashes.

Figure 2.1 Press and Set Buttons

55-003823-001CC

2-1

Operating Instructions

Read Spun Hematocrit Tubes inside Rotor

1. Press button 2. Set button

Figure 2.2 LEDs that Flash

1. LED that flashes for step 3. 2. LED that flashes for step 4.

4

Move the pointer to the bottom of the red blood cells (top of the clay). Then press Set.
The system displays 0 in the digital display.

The LED next to the label Move pointer to top of plasma. Set "100" flashes.

5

Move the pointer to the top of the plasma (plasma and air interface). Then press Set.
The system displays 100 in the digital display.

The digital display becomes active, and numbers change as you move the pointer.

6

Move the pointer slowly to the plasma and red cell interface, and then press Press.

Note

To avoid false readings, do not press the membrane on either side of the gliding
pointer arm.

7

Read the digital display, and record the number.

8

Turn the rotor for the next tube to be read, and press Set to initiate the next reading.

9

Continue until all tubes are read and recorded.

2-2 55-003823-001CC

Use 75 mm Adapter

1

Move the pointer completely to the right. Place the tube adapter in the slot in the center
of the digital reader.

2

Place the spun 75 mm hematocrit tube in tube adapter (clay on the right). Slide the
hematocrit tube completely to the right. Follow steps 1 to 5 in the Read Spun
Hematocrit Tubes inside Rotor to read the tube. Record the result.

Readout Setting

The digital display can be set to read either percent or decimal figures. When the digital
reader is shipped, it is set in the percent mode. The mode can be changed from a percent to
a decimal figure.

Operating Instructions

Use 75 mm Adapter

2

1

Remove the base plate on the underside of the digital reader by removing four Phillips
screws. Set the base plate and screws aside.

2

Move the jumper (small black piece) from pins 1 + 2 to pins 2 + 3.

Figure 2.3

1. Detail A

2. Jumper

3. Percent Mode

4. Pin 3

5. Negative

6. Bulb

7. Positive

8. Fiber Optic Bundle

55-003823-001CC 2-3

Operating Instructions

Cleaning

Cleaning

The instruction overlay on the digital reader has a protective coating. To clean the
instrument, dampen an absorbent tissue with warm water and a mild detergent and wipe
all surfaces.

Troubleshooting and Maintenance

The error indicator "flashing zero" indicates an error in the reading sequence. Repeat the
reading. Select Set to reset and begin the reading process.

The light is the only user-serviceable part of the digital reader. To replace the light, remove
the bottom plate by releasing the four screws on the underside. For more information, refer
to Readout Setting figure. Gently dislodge the bulb by pulling out the bulb. Remove bulb
and snap in new bulb. Replace the component to the original position.

The StatSpin CritSpin Digital Reader has no other user-serviceable parts. If a problem
occurs, the operator must contact Beckman Coulter Customer support 1-800-854-3633.
Disassembly of the unit voids the warranty.

2-4 55-003823-001CC

Specifications

Product No. CSD2 (supplied with the digital reader)

Model No. S120

Electrical 24 Volts DC, 1.7 amps.

Dimensions Height: 2 3/8” 6.0 cm

Environmental Indoor use

APPENDIX A

Specifications

Power supplied by switching power supply for 100-240 VAC, 50/60 Hz.

Width: 6 7/8" 17.5 cm

Length: 6 3/8” 16.2 cm

Weight: 1.25 lbs. 0.6 kg

Altitude up to 2000m

Accessories List

X01-003553-001 Power Supply

X01-003877-001 Light Bulb for Digital Reader

X00-002227-001 RH12-1 12-position Hematocrit Rotor

Plastic and glass tubes are available from your local dealer, or Contact Beckman Coulter
Customer Support 1-800-854-3633.

Operating temperature: 15°C to 32°C

Maximum relative humidity 80% for temperatures up to 31°C decreasing linearly
to 50% relative humidity at 40°C.

Main supply voltage fluctuations not to exceed +/- 10% of the nominal voltage.

Transient overvoltages according to installation category II

Pollution degree 2

CritSpin Digital Reader AccessoriesTable A.2

PN Description

55-003823-001CC

A-1

Specifications

Accessories List

A-2 55-003823-001CC

References

APPENDIX B

References

1

Clinical Laboratory Standards Institute. Proposed Guideline, Protection of Laboratory
Workers from Instrument Biohazards, Document I 17-P, Vol. 11, No. 15, Appendix A, Pg.

61.

2

CDC. Recommendations for prevention of HIV transmission in health care settings. MMWR
(Suppl. No. 2S):2S-18S, 1987.

3

CDC. Update: Universal precautions for prevention of transmission of human
immunodeficiency virus, hepatitis B virus and other blood borne pathogens in health care
settings. MMWR 37:377-387, 1988.

4

Clinical Laboratory Standards Institute. Quantities and Units: SI; Committee Report. CLSI
Publication C11-CR. CLSI, Villanova, PA 1983.

5

Clinical Laboratory Standards Institute. Procedure for Determining Packed Cell Volume
by the Microhematocrit Method. Approved Standard. CLSI Publication H7-A. NCCLS,

Villanova, PA, 1985.

6

Miale, JB, Laboratory Medicine: Hematology, 5th Edition, C.V. Mosby Co., St. Louis, 1977.

7

Clinical Laboratory Standards Institute. Procedures for the Collection of Blood by
Venipuncture, 2nd Edition; Approved Standard. CLSI Publication H3-A2. CLSI, Villanova,

PA, 1984.

8

Fairbanks, VF, Nonequivalence of Automated and Manual Hematocrit and Erythrocytic
Indices, Am. J. Clin. Path. 73:55-62, 1980.

9

Meites, S., Pediatric Clinical Chemistry: 3rd Edition, Amer. Assoc. for Clin. Chem.,
Washington, DC. 1989.

55-003823-001CC

B-1

References

References

B-2 55-003823-001CC

www.beckmancoulter.com

©

2018 Beckman Coulter, Inc.

All Rights Reserved.