CellSolutions 30 User manual

CellSolutions 30
Operator’s Manual
Document Number: CS-OP-30US
Rev. 07
Issue Date: July 24, 2020

CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 ii
Copyright 2015 - CellSolutions, LLC. All rights reserved. No part of this manual or the described software
may be copied, reproduced, translated or reduced to any electronic medium or machine-readable form without
the prior written consent of CellSolutions, LLC., except that you may make one copy of the program and
related files for back-up purposes.
Although this manual was prepared with every precaution to ensure accuracy, CellSolutions assume no
liability for errors or omission, nor for danger resulting from application or use of this information.
C
P
CELLSOLUTIONS GmbH
Halbinselstr. 37
88142 Wasserburg, Germany
M
CellSolutions, LLC.
1100 Revolution Mill Drive
Suite 1
Greensboro, NC 27405, USA

CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 iii
Table of Contents
Preface
v
Information about this Manual
v
General Information
v
Warranty and Contact Information
v
Section 1.0 Introduction
1-1
1.1 Intended Use
1-1
1.2 Requirements
1-1
1.3 Hazards and Warnings
1-1
Section 2.0 Specifications and Installation
2-1
2.1 Equipment Specifications
2-1
2.2 Recommended Installation Space
2-2
2.3 Installation and Setup
2-3
2.4 Power the Unit
2-3
2.5 Aligning Unit for Operation
2-4
2.6 Transport, Storage, Disposal
2-4
Section 3.0 Material Requirements
3-1
3.1 Reagents
3-1
3.2 Re-usable Materials
3-1
3.3 Consumable Materials
3-1
Section 4.0 Operation Overview
4-1
4.1 Specimen Identification
4-1
4.2 Slide Presentation and Barcoding
4-1
4.3 Specimen Volume Detection
4-1
4.4 Specimen Dilution
4-1
4.5 Specimen Mixing and Transfer
4-2
4.6 Specimen Application to Slide
4-2
4.7 Loading Slide into Staining Rack
4-2
4.8 Specimen Drying
4-2
Section 5.0 Sample Preparation
5-1
5.1 Sample Collection
5-1
5.2 Sample Identification and Tracking
5-1
5.3 Sample Transfer
5-1
5.4 Centrifugation
5-1
5.5 Decanting
5-2

CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 iv
5.6 Vortexing
5-5
Section 6.0 Operating Procedure
6-1
6.1 Software Operator Interface
6-1
6.2 Operating Modes
6-1
6.3System Initialization
6-3
6.4 Startup Checks
6-3
6.5 Processing Samples
6-9
6.6System Utilities
6-12
6.7 System Shutdown
6-15
Section 7.0 Maintenance
7-1
7.1 Daily Maintenance
7-1
7.2 Weekly Maintenance
7-1
7.3 Semi-Annual Maintenance
7-2
Section 8.0 Troubleshooting
8-1
Appendix A Glossary of Terms
A-1
Appendix B Glossary of Symbols
B-1
Appendix C Microscope Slide Printer
C-1
Index

CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 v
PREFACE
Information About This Manual
This manual provides information on the installation, operation and
maintenance of the CellSolutions 30 System and its software.
Throughout the manual the following three notices are used to highlight
important information:
WARNING: INDICATES THE POSSIBILITY OF SEVERE
PERSONAL INJURY OR LOSS OF LIFE IF INSTRUCTIONS ARE
NOT FOLLOWED.
Caution: Indicates the possibility of severe equipment damage if
instructions are not followed.
Note: Indicates useful information.
General Information
This device is intended for the preparation of thin-layer cell
presentations on microscope slides for subsequent staining and
evaluation. All users of the device should be appropriately trained on
the uses of the device and have an understanding of the overall slide
preparation and screening process.
WARRANTY INFORMATION
The CellSolutions 30 has a one-year warranty from the date of sale. For
technical support or repair information contact your designated local
representative or CellSolutions.
CellSolutions
1100 Revolution Mill Drive
Greensboro, NC 27405, USA
[phone]

Introduction
CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 1-1
1.0 INTRODUCTION
1.1 Intended Use
The CellSolutions 30 automates certain steps in the process of preparing a microscope slide with
a thin layer of cells for microscopic visual evaluation. The unit takes as input, preserved cell
samples that have already been concentrated by centrifugation. The system then outputs
optimized samples of approximately the same cellularity onto microscope slides that are ready for
staining.
1.2 Requirements
The device is designed to use the specific reagents and consumable materials identified in this
manual (i.e. reagents, disposable tubes, automated pipette tips, stain shield labels). Use of other
reagents and materials may damage the device and cause incorrect results as well as render the
warranty invalid.
The samples should be collected by experienced professionals using an acceptable cervical
sampling device that allows detachment or thorough rinsing of the brush or spatula head in the
preservative vials. The vials used for collection are BestPrep®General Cytology Preservative
Vials (C-101-500).
1.3 Hazards and Warnings
1.3.1 Chemical Hazards
The fluids processed by the device are biological samples that may contain infectious
material.
WARNING: SPECIMENS MAY CONTAIN INFECTIOUS MATERIAL.
WEAR PROTECTIVE CLOTHING AND AVOID CONTACT WITH
SPECIMEN.
WARNING: IF A SPILL OCCURS, WIPE CLEAN THE AFFECTED
AREA USING APPROPRIATE CLEANING MATERIAL FOR THE TYPE
OF SPILL. POTENTIAL BIOHAZARD CLEAN UP MAY USE A TOWEL
LIGHTLY DAMPENED WITH A 10% BLEACH SOLUTION.
1.3.2 Mechanical Hazards
The CellSolutions 30 is controlled by a computer in communication with sensors and
motors that when properly operated should prevent any accidental harm to the operator.
The operator should take reasonable care not to interfere with moving parts of the system
while in operation.

Introduction
CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 1-2
1.3.3 Electrical Hazards
The CellSolutions 30 has 2 items that are separately plugged into an alternating current
supply. The 2 items are a computer and the CellSolutions 30 Processing Platform. Each
item operates on 100 to 240 volts and 50 to 60 Hz. Usual electrical precautions should
be observed.

Specifications and Installation
CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 2-1
2.0 SPECIFICATIONS AND INSTALLATION
2.1 Equipment Specifications
The system comes with a CellSolutions 30 processing platform, a computer and a Smart
Card reader. A separate centrifuge and vortex mixer that is not provided with the system
is needed to perform the overall process. The centrifuge and vortex mixer listed below
are suggested units, however, others may be used as long as they can achieve the
required G-forces and mixing requirements of the process. The physical dimensions and
specifications for each unit are as follows:
2.1.1 CellSolutions 30:
Dimensions: Width: 430 mm (17 inches)
Depth: 580 mm (23 inches)
Height: 740 mm (29 inches)
Power: Configuration 1: 120VAC, 60Hz
•CellSolutions 30 platform –6.2 amps
•Computer –0.5 amps
Configuration 2: 240VAC, 50Hz
•CellSolutions 30 platform –3.1 amps
•Computer –1 amp
(Note: Operation at 100VAC to 240VAC is
acceptable.)
Weight: 41 kg (90 lbs)
Operating Temperature: 5Cto 35C (41to 95F)
Relative Humidity: 30 to 80% RH, non-condensing
Throughput: 30 slides per hour (may vary based on sample size)
Barcode: Code 128, DataMatrix, PDF417 (Other formats available
–
Contact Authorized Representative)
Remote Access: Remote Troubleshooting Support (Contact
Authorized Representative for availability)
Computer: System runs on a computer with a Windows 7 or later
operating system that is connected with a USB cable.

Specifications and Installation
CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 2-2
2.1.2 Centrifuge:
A centrifuge is required but not provided. The following centrifuge is suggested
as being one that is compatible with the CellSolutions 30 system:
Manufacturer: Drucker
Model: Horizon 24 Flex with six-bucket rotor
Dimensions: Width: 380 mm (15 inches)
Depth: 430 mm (17 inches)
Height: 230 mm (9 inches)
Power: Configuration 1: 120VAC, 60 Hz, 1 amp
Configuration 2: 240VAC, 50 Hz, 0.5 amps
Weight: 17 kg (37 lbs)
Capacity: 24 tubes (6 position rotor with a 4-tube
rack in each position)
2.1.3 Vortexer:
A vortex mixer is required but not provided.
A standard laboratory vortex mixer with comparable specifications to the unit
noted below is acceptable.
Manufacturer: Thermolyne
Model: Maxi Mix II, No. M37615
Dimensions: Width: 130 mm (5 inches)
Depth: 200 mm (8 inches)
Height: 150 mm (6 inches)
Weight: 3 kg (6 lbs)
2.2 Recommended Installation Space
In addition to the bench top space required to hold the CellSolutions 30 platform, space is
also needed for the computer and for handling tubes, racks, and slides.
Recommended Bench Space for CellSolutions 30:
Width: 1200 mm (48 inches)
Depth: 750 mm (30 inches)
Height: Approximately 800 mm (32 inches)
Recommended Bench Space for centrifuge, vortex mixer, and handling:
Width: 1200 mm (48 inches)
Depth: 750 mm (30 inches)
Height: Not critical.

Specifications and Installation
CellSolutions 30 Operator’s Manual CS-OP-30US Rev. 07 2-3
The above dimensions are recommended values. Each installation site’s space will vary
based on space constraints and usage volumes.
2.3 Installation and Setup
The CellSolutions 30 should be placed on a sturdy and stable table that does not tilt or
flex.
The unit can be placed with the back toward a wall so long as there is at least 50 mm (2
inches) of space between the unit’s back and the wall. This space provides ventilation for
unit cooling.
Once the unit is in its final place on the table, the 4 machine feet should be adjusted to
level the machine. The feet should be adjusted until the bubble in the level attached to
the rotary table is centered. All 4 feet must be adjusted so they are touching the table
and the unit does not tilt back and forth on two feet.
Note: It is critical that the machine be completely level so that the cell suspension
deposited on the slide does not run off the slide or pool toward one side of the deposit
area. If the solution pools to one side, that side will have a higher cell concentration than
the rest of the slide.
Note: Any time the machine is moved, the level should be re-checked and adjusted if
necessary.
The tubing to the pump should be placed in a reservoir bottle or container. The container
should be filled with a 50% ethanol solution.
The tubing that is connected to the priming station standpipe should be routed to a
discharge collection container or to a drain.
During operation, the unit ejects used pipette tips into the detachable tip chute toward the
back left of the instrument. The detachable tip chute is held in place with a threaded
thumb screw so the chute can be easily removed for cleaning with a dilute bleach
solution. A small metal pin is on the top of the tip chute for attaching a tip disposal bag
such as a Whitney Products Safe-Keeper Container (Item BH2005). Other suitable leak
proof tip disposal containers may also be used and are the option of the user.
2.4 Powering the Unit
The CellSolutions 30 processing platform and the computer have separate power cords.
Each of these components can be powered with 100 to 240 VAC and 50 to 60 Hz.
Check that the available power is correct before plugging the components into the wall
socket.
The computer is connected to the processing platform with a USB cable. The cable
should be connected to the USB connection marked on the computer and the square
USB connection under the air inlet on the back of the machine.
The Smart Card reader is plugged into a USB port on the computer.