Cell Isolation, Enumeration, and Enrichment

Genesis Cell Isolation System
User Guide

Introduction

The Genesis Cell Isolation System enables a range of single-cell applications with Celselect Slides™
technology.
Celselect Slides capture and isolate individual circulating tumor cells (CTCs) and other rare cells basedon their size, utilizing microfluidics and individual microchambers. Isolated cells can be stained for
immunofluorescent applications such as enumeration, or enriched for downstream methods such ascell culture or single-cell genomics.
Features
Genesis System

Semiautomated workflow
Flexibility to run 1 or 2 Celselect Slides at a time
■ Network-ready for remote updates and support■ Open design for user-customized applications and protocols■■

Celselect Slides and Consumables

Microchambers capture CTCs based on size
High capture efficiency■ Ability to customize staining■■

Components Overview
The following figures and Tables 1–8 outline the main components
and details of the Genesis System for operation.

Table 1. Genesis System front.
Number

Front Component

1

USB 2.0 port

2

Genesis System touch screen

3Power indicator light4

Lid

Table 2. Genesis System back.

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NumberBack Component

1

24 VDC power input

2

Ethernet port

3

USB 2.0 port

4Power switch

Genesis Cell Isolation System User Guide

Table 4 describes the accessories used in conjunction with theGenesis System for operation.
Table 4. Genesis System accessories.
Component

Description

Celselect Slides
stationOrients and stabilizes Celselect Slides on the
Genesis System.

Reagents cartridge
venterVendor:cartridge
Troutt Visual Services
Fits directly onto the chambers of the reagents
File Name: Fig_06 _CelselectDate: 02/26/24
and opens the chambers for use on the Genesis
System.
Proof:4
Required to prevent the formation of a vacuum and to allow
proper flow of reagents.

Wireless barcode
scanner and baseScans barcodes that are included on consumables.

Celselect imaging
slide adaptor

Holds up to two Celselect Slides and fits directly in any
automated microscope.

Table 3. Genesis System interior.
Number Component

Description

1

Reagents cartridge
retainer

Keeps the reagents cartridge in place during
dispensing steps, while the disposable
cartridge piercer pushes up on the Reagents
Cartridge to pierce the bottom foil from below.

2

Reagents cartridge
spindleHolds the reagents cartridge in place during
the run to control the order of reagent
dispensation.

3

Piercer drip plate

Holds the disposable piercer used to pierce
the bottom foil of a reagents cartridge.

4

Actuator

Moves the piercer drip plate up and down
to perform reagents cartridge piercing anddispensing steps.

5

Liquid level sensor

Monitors the level of the reagents in theinlet funnel.

6

Manifold plate

Holds the slide station in place during the run.

7

Slide station
clamping box

Holds the Celselect Slides stations in the
manifold plate during the run.

8

Thermal blockTransfers heat to a slide, during heating andcooling steps, from an assembly below.

9

Vacuum tubing pin

Holds the free end of the vacuum tubing inplace while not in use.

10

Pinch valve

Holds the waste jar tubing during the run tocontrol the liquid flow through the slide.

11

Waste jar slot

Holds the waste jar in place during a run.

Project Title: CelselectVendor: Troutt Visual Services
File Name: Fig_05_CelselectDate: 02/26/24
Proof:4

Backflow adaptor© 2024 Bio-Rad Laboratories, Inc.

Project Title: Celselect2

Seals priming reservoir for enrichment cell collection.

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Consumables Overview

Getting Started

Table 5. Genesis System consumables.

Genesis Software Overview

The Genesis graphical user interface (GUI) is the main userinterface for operating the Genesis System. The GUI loads
automatically after startup and logs every run. The GUI home
screen has four options:

Consumable

Description

Celselect Slides

Celselect Slides use Bio-Rad’s proprietary CTC capture
and analysis technology. Each slide has one laminated sideand the other side contains inlet and outlet ports. Opticalcharacteristics closely mimic a glass slide, rendering the slide
Project Title: Celselectfit for imaging.
Vendor: Troutt Visual Services

Start
Logs
■ Maintenance■ Settings■■

One can also log in, gather system information, or shut down the
instrument from the home screen. Note: Login is not required.

File Name: Fig_08_CelselectDate: 02/26/24
Proof:4

Inlet funnel

The sample enters the Celselect Slides through theinlet funnel.

Project Title: CelselectVendor: Troutt Visual Services
File Name: Fig_07_CelselectDate: 02/26/24
Proof:4

Reagents
cartridge piercer

The reagents cartridge piercer is firmly placed in the drip
plate of the Genesis System to penetrate the bottom of
the reagents cartridge and allow reagents to enter the inlet
funnel.

Start
Click Start to bring up the Self Test screen.

Waste jar tubing

The waste jar tubing collects reagents after processing.

User-Supplied Consumables and Equipment

See individual application protocols and site preparation checklists
for complete lists of user-supplied consumables and equipment.
User-Supplied Consumables for Instrument Maintenance
Table 6. User-supplied consumables for instrument maintenance.
Consumable

Source10% bleach

Major lab supplier

70% ethanol

Project Title: CelselectMajor lab supplier

Water, laboratory-grade*

After selecting the lane, or both, to conduct a self test on, theMajor lab supplierFile Name: Fig_14_CelselectVendor: Troutt Visual Services

instrument will confirm:

Date: 02/26/24* Always use laboratory-grade water or deionized water to perform instrument
Proof: 4procedures. Never use tap water.

■

Reagents cartridges are not loaded■

Level sensors are unblocked■■© 2024 Bio-Rad Laboratories, Inc.

3

Waste jar inlet tubing is loaded into the pinch valve orotherwise clamped
Lid is closed

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Click Next to perform the self test.

When prompted, confirm that the proper consumables wereentered, then click Run.

The lane(s) is now ready to configure a run, starting with a prompt
to select the desired protocol to run.

Run in progress

Run complete

After a protocol is selected, the Celselect Slides reagents,
Celselect Slides consumables, and Celselect Slides can bescanned in with the barcode scanner or manually entered with theonscreen keyboard then loaded onto the instrument. If entering
manually, follow this naming scheme:
1.

Celselect Slides reagents: R######

2.

Celselect Slides consumables: M######

3.

Celselect Slides: S#########© 2024 Bio-Rad Laboratories, Inc.

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Settings
The Settings screen allows the user to control several functions.

■User Login■

The system can be run without logging in, but an Admin must log
in to access and manage user accounts in the system settings.
The default user login and password:■

User name: genesis
Password: Genesis01■

Time and Date

Set the time and date for the device.

■

■

■

The user can touch a text item on the highlighted line to select itfor modification
User identifications (IDs) cannot be modified once a user issuccessfully saved
The Enforce Login button updates login enforcement
immediately; it does not require clicking Save
When an Admin is logged in, that person’s Admin checkbox
will be grayed out and cannot be unchecked. Admins cannot
remove their own Admin privileges
The Save button will only be enabled once all changed data
is validated
When adding a new user, the Admin must input a valid user ID,
first name, and last name, and set the new user’s password
Once a user is created and the Admin wishes to change
someone else’s password, the Admin will be prompted to
re-enter the Admin password before changing the otheruser’s password

Best Practices
Good Laboratory Practices

Wear appropriate personal protective equipment.
Reagents Cartridge

Avoid pipetting bubbles into the reagent cartridge or inlet funnel.
Protocols

Operation

View currently installed system protocols, file names, andtimestamps. Insert a USB drive to import or export files.

Introduction

To perform any of the Bio-Rad certified protocols on the Genesis
System, initial setup steps are required. Different assays will
have different setups, which are addressed in the individual assay
protocols. This section provides a high-level overview. Once thesetup is complete, the Genesis System will perform a systemself test followed by a set of software prompts to configure a run.
Prepare Samples, Prime Slides, and Load Samples

Follow the instructions detailed in the assay-specific protocol toprepare samples, prime slides, and load samples.
Prepare Reagents and Load Reagents Cartridge

Follow the instructions detailed in the assay-specific protocol toprepare and load the reagents as well as to load the slides into
their slide stations.

Accounts

Perform Self Test on the Genesis System

Add or modify accounts on the device.

Follow the instructions in the Start section of this guide to run
a self test.
MaintenanceRoutine Cleaning

Clean the Genesis System and slide stations after each use or
weekly when not in use.
■■

© 2024 Bio-Rad Laboratories, Inc.

5

Wipe instrument deck with 10% bleach solution on a toweletteIf 10% bleach solution is not available, wipe instrument deck with
70% ethanol on a towelette

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As-Needed Cleaning

Loading Protocols Using Protocol Builder

1.

In addition to running supported and validated protocols, theGenesis System can carry out customized protocols based onuser requirements using Protocol Builder. The Protocol Builder
process and supporting guidelines are described in the Protocol
Builder User Guide.

System Decontamination
WARNING! To prevent electrical shock, always turn off andunplug the instrument prior to performing decontamination
procedures. To prepare and apply the disinfectant, refer to the
instructions provided by the product manufacturer. Do not use
abrasive or corrosive detergents or strong alkaline solutions.
These agents can scratch the surfaces of the thermal block,resulting in loss of precise thermal control.

Shutting Down the Instrument■

Outer enclosure lid and chassis

The Genesis System can be left idle for up to 1 week. If theGenesis System is not going to be used for more than 1 week, theslide stations and all consumables should be removed from themachine. The machine should be turned off and cleaned. Oncethe machine is off for more than 1 week, it is recommended thatpreventive maintenance is performed.

■

Inner lane components, including the thermal block

Appendix 1: Troubleshooting– Rinse the thermal block several times with water after
applying disinfectant. Thoroughly dry the thermal block
after rinsing with water

1.

The following areas can be cleaned with any hospital-grade
bactericide, virucide, or fungicide:■2.

If either lane fails a self test, check the following to correct
the issue:

LCD screen

Tighten all fittings between the instrument and waste
Confirm waste jar tubing is not pinched or clamped■ Make sure the level sensor is unobstructed■

Cleaning Spills■

Clean up all spills immediately. Dispose of all samples andwaste according to proper handling procedures and local
regulations.
■

■

2.

■

■

Consult appropriate Safety Data Sheets when necessary

The Genesis System is designed to operate safely when used in
the manner prescribed by the manufacturer. If the Genesis Systemor any of its associated accessory components are used in amanner not specified by the manufacturer, the inherent protection
provided by the instrument may be impaired.

Software Updates

Bio-Rad is not liable for any injury or damage caused by the use ofthis equipment in any unspecified manner, or by modifications to
the instrument not performed by Bio-Rad or an authorized agent.
Service of the Genesis System should be performed only by
Bio-Rad personnel.

Regular updates to software and firmware are necessary to enable
the most current and effective programming. Updates can be
performed in one of four ways:
Remote access (see prior section)
Locally through the Settings page on the Genesis System
control module
During an on-site visit■

With update files and instructions shared by an engineer© 2024 Bio-Rad Laboratories, Inc.

 ontact your field application specialist forC
troubleshooting help

Some hazards are indicated on the instrument by labels shown inthis section.

At any point, the user may terminate the connection and end
remote access. In addition, the user can request in-person local
updates and maintenance, though this support is pending service
contracts and technician availability.

■

Allow the other lane to complete its processing

Appendix 2: Warnings, Hazards, and Safety Considerations
This section identifies potential hazards associated with operating
the Genesis System. Do not operate or interact with the system ina manner that causes exposure to these dangers.

The Genesis System comes with networking capabilities. Once
the Genesis System is installed, the field service engineer will, withpermission from the customer, establish a connection from the
instrument to the internet using a standard Ethernet port and LAN
connection. This connection can be used to update software andfirmware, to collect and analyze log files from previous runs, and tooperate the device.

■

Single Lane Failure
If one lane fails when processing two samples in parallel:

Always dispose of all consumables coming into contact withthe sample after each sample run in an appropriate manner

Remote Access■Self Test Failure

General Safety Warnings

Before operating the Genesis System, all personnel must be
trained in the correct operation of the instrument and any potential
safety considerations.

6

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Electrical Safety Warnings

Electrical Hazards

Do not remove any of the outer enclosure components from theGenesis System. There are no user-serviceable components
inside. If the instrument is operated with the enclosure removed,
the user may be exposed to line voltage as well as to DC voltages.

The Genesis System poses no uncommon electrical hazard tooperators if installed and operated properly without physicalmodification and connected to a power source of proper
specification.

The Genesis System is powered by 100–240 volts AC operating
at either 50 or 60 Hz. Most of the voltage sources are located at
the back right side, under the enclosure. Some voltage is present
on the instrument even when the instrument is powered down.
Operate the instrument with the enclosure intact to avoid electricalshock.

Battery

The Genesis System uses a 3 V lithium manganese dioxide
nonrechargeable coin cell battery to maintain time and datesettings in the event of AC power loss. If the time and date settings
do not remain set after the unit is turned off, it may be an indicationthat the battery is weak or has no charge. If this occurs, contact
Bio-Rad Technical Support for assistance.

Electrical Connections

The Genesis System should be plugged into a dedicated, groundedcircuit capable of providing at least 10 amps for a 100–120 V powersource or 6 amps for a 220–240 V power source.

WARNING! Do not attempt to change the battery. Contact
Bio-Rad Technical Support.
For the State of California, USA, only:

For more information, see the Genesis System Site Preparation
Guide.

■

Perchlorate material — special handling may apply.
See dtsc.ca.gov/hazardouswaste/perchlorate

Hot Surface Safety Warning■

Do not operate the Genesis System with any of the enclosure
panels removed.

Transport

Perchlorate material — lithium battery contains perchlorate

Before moving or shipping the Genesis System, decontamination
procedures must be performed. Always move or ship the Genesis
System with the supplied packaging materials to protect the
instrument from damage. If appropriate containers cannot befound, contact your local Bio-Rad representative.

Do not touch the thermal block of the slide station manifold plate.
The Peltier controller used in the thermal block normally operates
at ambient temperature (22°C) but can range from 5 to 105°C.
Exposure to temperatures at the upper end of this range could
result in burns.

Transport/Storage Environmental Conditions

The Genesis System can be stored under the following conditions:

WARNING! Hot surface! This symbol identifies
components that pose a risk of personal injury due
to excessive heat if improperly handled.
Important: The thermal blocks can become hot
enough during normal operation to cause liquids toboil and explode.

■

Temperature range: –20 to 60°C■

Relative humidity: maximum 80%

Disposal

The Genesis System contains electrical materials; itshould be disposed of as unsorted waste and must
be collected separately according to the EU Directive
2002/96/CE on waste and electronic equipment.
Before disposal, contact your local Bio-Rad
representative for country-specific instructions.

A thermal cycler generates enough heat to cause serious burns.
Always allow the thermal block(s) to return to ambient temperature
before opening the lid and removing the slide. Always allow
maximum clearance to avoid accidental skin burns.
Biohazards

Disposal of Instrument Waste

The Genesis System is a laboratory product. However, if
biohazardous samples are present, adhere to all laboratory, local,
regional, and national guidelines. See Routine Cleaning section for
more information on decontamination.

■■

Chemical Hazards

Disposal of instrument — contact Bio-Rad Tech Support

Disposal of Biohazardous Material

The Genesis System contains no potentially hazardous chemicalmaterials.

The Genesis System contains no hazardous chemical materials.
Dispose of the following potentially contaminated materials
in accordance with laboratory, local, regional, and national
regulations:

Explosive or Flammability Hazards

The Genesis System poses no uncommon hazard related to
flammability or explosion when used in a proper manner as
specified by Bio-Rad.

■

Clinical samples■

Reagents■© 2024 Bio-Rad Laboratories, Inc.

Waste jars — the Genesis System has a dedicated waste jar
for each run. Collect and dispose of all waste jars using proper
precautions in accordance with local safety regulations

7

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Safety Specifications and Compliance

Symbols Used on the Instrument or Kits

Safety specifications for the Genesis System are listed in Table 8.
Shielded cables (supplied) must be used with this unit to ensurecompliance with the Class A Federal Communications Commission(FCC) limits.

Table 7. Symbol list.
SymbolMeaning
Manufacturer

Table 8. Safety specifications.
Date of manufacture

LOT

Batch code

Catalog number

SN

Serial number

Safety Guideline

Specification

Operating condition

Indoor use

Temperature

65–83°F (18–28°C)

Humidity

20–80% noncondensing

Elevation

Below 6,500 feet (1,981 meters)

Installation (overvoltage)
category

II (external power supply plugs into standard AC
receptacle)

Air quality

Pollution Degree 2 per IEC 60664-1

Electrical supply

100–240 VAC, 50/60 Hz, 200 W

Main supply voltage
fluctuations

Not to exceed ±10% of nominal voltage

Regulatory ComplianceThis instrument has been tested and found to be in compliancewith all applicable requirements of the following safety andelectromagnetic standards:

Consult instructions for use

Warning: hot surface

European conformity■

UL 61010-1:2018, Third Edition Dated May 11, 2012■

UL 61010-2-010, Fourth Edition Dated June 27, 2019■

UL 61010-2-101, Third Edition Dated July 31, 2019■■

Waste Electrical and Electronic Equipment Directive■

Biological risks■

Temperature limit

IEC 61010-1 Electrical Equipment for Measurement, Control, andLaboratory Use, Edition 3 (2010-06)+AMD1 (2016-12)
IEC 61010-2-010 Particular Requirements for Laboratory
Equipment for the Heating of Materials, Fourth Edition
IEC 61010-2-101 In Vitro Diagnostic (IVD) Medical Equipment(2018-10)
 N 61326-1:2006 (Class A) Electrical Equipment forE
Measurement, Control, and Laboratory Use. EMC Requirements,
Part 1: General Requirements
The CE mark indicates that the manufacturer ensures
the product conforms with the essential requirementsof the applicable EN directives.

Do not reuse

The UL mark indicates that a product has been tested
to Canadian and U.S. standards, and it meets therequirements of those applicable standards.
This equipment has been tested and found to comply with thelimits for a Class A digital device pursuant to Part 15 of the FCC
rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in acommercial environment.

© 2024 Bio-Rad Laboratories, Inc.

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Bio-Rad Technical Support
The Bio-Rad Technical Support department in the U.S. is open
Monday through Friday, 5:00 AM to 5:00 PM, Pacific time.
Phone: 1-800-424-6723, option 2
Email: support@bio-rad.com (U.S./Canada only)
For technical assistance outside the U.S. and Canada, contact
your local technical support office or click the Contact us linkat bio-rad.com.
Legal Notices
No part of this publication may be reproduced or transmitted in any form or by any means,electronic or mechanical, including photocopy, recording, or any information storage or
retrieval system, without permission in writing from Bio-Rad Laboratories, Inc.
Bio-Rad reserves the right to modify its products and services at any time. This guide issubject to change without notice. Although prepared to ensure accuracy, Bio-Rad assumes
no liability for errors or omissions, or for any damage resulting from the application or useof this information.
BIO-RAD and CELSELECT SLIDES are trademarks of Bio-Rad Laboratories, Inc. in certain
jurisdictions. All trademarks used herein are the property of their respective owner.
© 2024 Bio-Rad Laboratories, Inc.

For research use only. Not for use in diagnostic procedures.

Bio-RadLaboratories, Inc.
Website bio-rad.com USA 1 800 424 6723 Australia 61 2 9914 2800 Austria 00 800 00 24 67 23 Belgium 00 800 00 24 67 23 Brazil 4003 0399
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