Thermo Fisher Scientific Genexus Integrated Sequencer User guide

Brand
Thermo Fisher Scientific
Model
Genexus Integrated Sequencer
Type
User guide
Genexus™ Integrated Sequencer
Publication NumberMAN0017918 RevisionG.0
This guide contains the information that is needed to prepare your site for installation of an Ion Torrent™
Genexus™ Integrated Sequencer (Cat.No.A45727).
Site preparation workflow
IMPORTANT! Thermo Fisher Scientific does not install, service, or repair products in areas designated
BioSafety Level 3 (BSL-3) or BioSafety Level 4 (BSL-4).
A Thermo Fisher Scientific service representative will contact you to schedule the installation. When the
installation date is scheduled, perform the following tasks.
Site preparation workflow
Review this site preparation guide
Complete the site preparation checklist (page2)
Complete, date, and initial all items in the checklist before the scheduled installation
date.
Receive and inspect the shipment (page16)
•Verify that items ordered were shipped.
•Inspect the shipping containers and report any damage.
•Unpack the installation kit and store as directed.
Move the crated shipment to the installation site
(page17)
•Prepare the installation site.
•Move the crated instrument to the site.
SITE PREPARATION GUIDE
For Research Use Only. Not for use in diagnostic procedures.
Site preparation checklist
IMPORTANT! Complete, date, and initial all items in the following checklist before the scheduled
installation date. If the site preparation checklist is not complete when the service representative arrives,
the scheduled installation may be postponed.
✓Date Initials Site preparation requirement See page
 Customer responsibilities have been reviewed. 3
 Personnel have been assigned tasks and responsibilities.
 The installation site is identified and meets the following requirements:
 Space and clearance 4
 Environmental 7
 Electrical 10
 Network 12
 Instrument-to-computer connection 6
 Safety 14
 The shipment was received and inspected as follows:
 The items shown on the shipping list are the items that were ordered
at the time of purchase.
16
 Damage to shipping containers was reported to the shipping
company that delivered the shipment and to your service representative.
 Damage or mishandling was recorded on the shipping documents.
 If provided with the shipment, all reagents and plates are unpacked
and stored as specified on package labels.
 The installation site is cleared and ready for the installation.
17
 The packaged shipping containers are moved to the installation site.
 All materials for installation, qualification, and operation are available. 15
 The Genexus™ Integrated Sequencer IT Checklist (Pub.No.MAN0018466)
has been completed and returned according to the checklist instructions.
18
Customer signature:
Site preparation checklist
2Genexus™ Integrated Sequencer Site Preparation Guide
Customer responsibilities
Personnel Responsibilities
Site preparation/
installation
coordinator
•Reviews the site preparation guide for safety information and instrument requirements.
•Coordinates personnel and tasks.
•Chooses the site.
•Reviews checklists with applicable personnel, then with the service representative to
verify that the site is properly prepared.
•Receives and inspects the Genexus™ Integrated Sequencer.
•Stores the installation kit contents according to the specifications provided in this guide
(see “Installation kit” on page15).
•Schedules the installation and informs personnel of the installation day.
•Ensures that the site is clear of unnecessary material on the installation day.
•Is available to assist the service representative throughout installation.
Laboratory safety
representative
•Reviews the site preparation guide for safety information.
•Ensures that the required safety practices and equipment are in place.
•Is in the vicinity and available to the service representative at all times while the service
representative is at the customer's facility.
Laboratory
personnel/ primary
users
•Reviews safety information.
•Ensures that all customer-provided materials for installation are present at the site.
•Ensures that primary users (responsible for training other users) are available during the
installation, so that they can be trained on the instrument.
Facilities personnel •Ensures that the installation requirements are met for:
–Space at the installation site
–Building clearances
–Temperature and humidity
–Waste collection
–Electrical supply
–Safety and installation materials
•If possible, moves the crated Genexus™ Integrated Sequencer to the site before the
installation date.
•Is available to assist service representative and laboratory personnel throughout
installation.
•If applicable, ensures that at least two people are available to help the service
representative move and position the instrument.
Customer responsibilities
Genexus™ Integrated Sequencer Site Preparation Guide 3
(continued)
Personnel Responsibilities
Network or IT
specialist (if the
instrument will be
connected to a
network)
•Ensures that active, tested local area network (LAN) connections are in place before the
scheduled installation date.
•Ensures that network hardware is compatible with an RJ45-type connector.
•If necessary, supplies additional cables.
•Is available during installation to connect the Genexus™ Integrated Sequencer to the
network.
IMPORTANT! Do not attempt to connect the Genexus™ Integrated Sequencer to the
network before the service representative arrives.
Site requirements
Dimensions and weights
To prepare for installation, provide space for receipt and configuration of the components listed in
this section. This section provides dimensions and weights for the packages you will receive, and it
describes the dimensions of the components after installation and configuration.
Crates and packages
CAUTION! PHYSICAL INJURY HAZARD. Do not attempt to lift or move the instrument without
the assistance of others, the use of appropriate moving equipment, and proper lifting techniques.
Improper lifting can cause painful and permanent back injury. Depending on the weight, moving or
lifting an instrument may require two or more people.
MISE EN GARDE! RISQUE DE BLESSURE PHYSIQUE. N’essayez pas de soulever ou de dépla
cer l’instrument sans l’aide d’autres personnes et sans utiliser les équipements de déplacement et
les techniques de levage adaptés. Un levage incorrect peut provoquer des lésions douloureuses et
permanentes du dos. Le levage ou le déplacement d’un instrument peut nécessiter deux personnes
ou plus, selon le poids.
Ensure that the building clearances allow for the passage of the instrument crates and packages. In
addition, 18 linear feet (5.5 m) of clearance are required to uncrate the sequencer. When uncrating,
one side of the shipping crate serves as a ramp to roll the wheeled sequencer from the crate pallet
to the floor. If the installation site does not have adequate space to deploy the ramp, leave the crated
instrument in a secure receiving area that has sucient space to deploy the ramp.
Crate Height Length (depth) Width Weight
Genexus™ Integrated Sequencer 75.1 in (190.7 cm) 41.7 in (105.8 cm) 57.6 in (146.2 cm) 896 lbs (407 kg)
Site requirements
4Genexus™ Integrated Sequencer Site Preparation Guide
Components
Ensure that the installation site floor space is level and can accommodate the dimensions.
Component
Height Length (depth) Width
Weight
Open Closed Open Closed Open Closed
Genexus™
Integrated
Sequencer
81.1 in
(205.9
cm)
66.1 in
(167.8cm)
43.5 in
(110.5cm)
32.1 in
(81.6cm)
58.5 in
(148.7cm)
41.9 in
(106.5 cm)
450 lb
(204.1kg)
32.1 in
81.6 cm
58.5 in
148.7 cm
41.9 in
106.5 cm
66.1 in
167.8 cm
81.1 in
205.9 cm
43.5 in
110.5 cm
Figure1Instrument dimensions
CAUTION! PHYSICAL INJURY HAZARD. Do not attempt to lift or move the instrument without
the assistance of others, the use of appropriate moving equipment, and proper lifting techniques.
Improper lifting can cause painful and permanent back injury. Depending on the weight, moving or
lifting an instrument may require two or more people.
MISE EN GARDE! RISQUE DE BLESSURE PHYSIQUE. N’essayez pas de soulever ou de dépla
cer l’instrument sans l’aide d’autres personnes et sans utiliser les équipements de déplacement et
les techniques de levage adaptés. Un levage incorrect peut provoquer des lésions douloureuses et
permanentes du dos. Le levage ou le déplacement d’un instrument peut nécessiter deux personnes
ou plus, selon le poids.
Site requirements
Genexus™ Integrated Sequencer Site Preparation Guide 5
Instrument clearances
During instrument setup and maintenance, it is necessary to access the back and sides of the
instrument. If the back of an instrument component faces a wall, it is necessary to have enough space
to roll the instrument out from the wall to enable access to the back of the instrument.
IMPORTANT! For safety, the power outlet that is used for powering the instrument must be accessible
at all times.
Component Top Front Left/Right Back
Genexus™ Integrated Sequencer 20 in (50.8 cm) 18 in (45.7 cm)[1] 6 in/12 in[2]
(15.2 cm/30.5 cm)
12 in (30.5 cm)
[1] The instrument requires 36.0 in (90.0 cm) aisle in front of bench for operator access.
[2] To allow sufficient side clearance for the instrument doors to open.
Laboratory layout of the Genexus™ Integrated Sequencer
The Genexus™ Integrated Sequencer is equipped with an internal server and only requires connection to
a local area network (Figure2).
Figure2Genexus™ Integrated Sequencer configuration
1
2
4
3
1Genexus™ Integrated Sequencer
2Local area network
3Internet
4Client computer
Site requirements
6Genexus™ Integrated Sequencer Site Preparation Guide
Internet connectivity
The Genexus™ Integrated Sequencer should be connected to a network with internet access.
Connecting to the internet allows you to update your software and access remote system support
easily. Software updates through the network/internet are free. If you do not connect your instrument to
a network, software updates must be manually installed via a USB drive.
IMPORTANT! Thermo Fisher Scientific does not support the USB drive method for updating software.
Any problems (for example, file corruption, or incomplete updates) resulting from update of the
sequencer or server using a USB device that require correction of the faulty update is not covered
by your Genexus™ Integrated Sequencer warranty or any service contract you may have purchased.
You are required to schedule an on-site Time and Materials visit by a field service engineer to correct
the problem at your own expense.
In providing outbound access to the Internet from the server, you enable the support team to provide
inbound support. The Genexus™ Integrated Sequencer runs a remote monitor agent that can provide
service personnel with critical system information, such as installed software versions and instrument
alarms. With your permission, the agent also allows service personnel to access the sequencer
remotely, which is required for system support. Without remote access, service personnel cannot
access, view, and troubleshoot problems regarding instrument performance.
To enable full support, the instrument must have outbound internet access (ports 22, 80, and 443), and
be behind an appropriately configured firewall. Although not recommended, you can enable access to
the internal server of the instrument. If you provide such access, you must restrict access to the server
using HTTP and AUTH firewall rules, or a combination of the two. Implementing and maintaining such
restrictions is the responsibility of your server administrator and not of Thermo Fisher Scientific.
Environmental requirements
Ensure that the installation room is maintained under correct environmental conditions. Avoid placing
the sequencer next to heaters, cooling ducts, or in direct sunlight. Place the sequencer at least 1 meter
away from major sources of electronic noise such as refrigerators or microwaves. Fluctuations between
day and night temperatures can cause system instability.
Component Acceptable range
Altitude Located between sea level and 2,500 m (8,200 ft) above sea level
Humidity 20%–70%, non-condensing
Operating
temperature
15°C to 30°C (59°F to 86°F)
IMPORTANT!
·The recommended operating temperature for the Genexus™ Integrated Sequencer
during install qualification and performance qualification runs is 23°C (73°F).
·If the sequencer is operated at an elevation of 1,800 m (5,900 ft) or greater above
sea level, the maximum operating temperature is 23°C (73°F).
·The room temperature must not fluctuate more than 2°C (3.6°F) over a 2‑hour
period.
Site requirements
Genexus™ Integrated Sequencer Site Preparation Guide 7
(continued)
Component Acceptable range
Vibration Do not install the instrument(s) near equipment that causes vibration (freezers, pumps,
and similar equipment). Significant vibration during sequencing can add noise and
reduce the quality of the sequencing measurements.
Electromagnetic
interference
The electromagnetic environment should be evaluated before placement and operation
of the instrument. Do not use the instrument in close proximity to sources of strong
electromagnetic radiation (for example, unshielded intentional RF sources), as these
sources can interfere with proper operation.
Pollution The Genexus™ Integrated Sequencer is intended to be used in Oce or Laboratory
controlled environments.
Other conditions For indoor use only. Install the sequencer on a level surface. The installation location
must be away from any vents that could expel particulate material on the system
components.
Thermal specifications for the instrument
During operation, the thermal output based on the typical current draw of the instrument is:
Component Typical draw[1] Thermal output
Genexus™ Integrated Sequencer 1000W 3412 BTU/h
[1] Maximum draw: 1200W
Ventilation requirements
Allow at least 12 in (30 cm) of clearance around the Genexus™ Integrated Sequencer for ventilation. Do
not block air inlets or outlets that allow proper ventilation.
Cleaning or decontamination
See the user documentation for your Genexus™ Integrated Sequencer for information on how to clean
or decontaminate the instrument.
Wear appropriate protection, including gloves, laboratory goggles, and coat whenever you work with
the fluids that are used on this instrument, or parts that may come into contact with these fluids.
Use only the cleaning agents as described in the user documentation for your Genexus™ Integrated
Sequencer. Use of cleaning agents that are not described in user documentation can impair the
instrument. Contact Technical Support if you have questions.
Wipe o any liquid on or near the instrument using a lint-free tissue.
Site requirements
8Genexus™ Integrated Sequencer Site Preparation Guide
Disposing of waste
WARNING! CHEMICAL HAZARD. Refer to Safety Data Sheets (SDSs) and local regulations for
handling and disposing of plastic consumables. Follow local municipal waste ordinances for proper
disposal provisions to reduce the environmental impact of plastic consumables.
AVERTISSEMENT! DANGER CHIMIQUE. Consulter les fiches de données de sécurité (FDS) et les
réglementations locales en matière de manipulation et d’élimination des consommables en plastique.
Se conformer à la réglementation locale relative à l’élimination des déchets usuels pour réduire
l’impact environnemental des consommables en plastique.
WARNING! CHEMICAL HAZARD. Before handling chemicals, refer to the Safety Data Sheet (SDS)
provided by the manufacturer, and observe all relevant precautions.
AVERTISSEMENT! DANGER CHIMIQUE. Avant de manipuler des produits chimiques, se référer
à la fiche de données de sécurité (FDS) fournie par le fabricant et respecter toutes les précautions
d’usage.
WARNING! CHEMICAL HAZARD. All chemicals in the instrument, including liquid in the lines, are
potentially hazardous. Always determine what chemicals have been used in the instrument before
changing reagents or instrument components. Wear appropriate eyewear, protective clothing, and
gloves when working on the instrument.
AVERTISSEMENT! DANGER CHIMIQUE. Tous les produits chimiques contenus dans l’instrument,
notamment le liquide dans les lignes, sont potentiellement dangereux. Toujours déterminer les pro
duits chimiques utilisés dans l’instrument avant le remplacement de réactifs ou de composants de
l’instrument. Porter des gants, des vêtements de protection et des protections oculaires appropriés
lors de toute intervention sur l’instrument.
WARNING! CHEMICAL HAZARD. Waste produced by instruments can be hazardous and can
cause injury or illness.
AVERTISSEMENT! DANGER CHIMIQUE Les déchets produits par les instruments peuvent être
dangereux et entraîner des blessures ou des maladies.
Site requirements
Genexus™ Integrated Sequencer Site Preparation Guide 9
Electrical requirements
WARNING! For safety, the power outlet used for powering the instrument must be accessible at all
times. See “Instrument clearances” on page6 for information about the space needed between the
wall and the instrument. In case of emergency, you must be able to immediately disconnect the main
power supply to the instrument. Allow adequate space between the wall and the equipment so that
the power cord can be disconnected in case of emergency.
AVERTISSEMENT! Par souci de sécurité, la prise de courant alimentant l’instrument doit être
accessible à tout moment. En cas d’urgence, il doit être possible de débrancher immédiatement
l’alimentation principale de l’ensemble des équipements. Laisser susamment d’espace entre le mur
et les équipements afin de pouvoir débrancher les câbles d’alimentation sans encombre, en cas
d’urgence.
•Electric receptacle required: 2-prong with ground pin
•Mains AC line voltage tolerances can be up to ± 10% percent of nominal voltage
•Use only the specified power cable supplied with the instrument to connect the sequencer to a wall
receptacle. Route the power cord away from the workspace to avoid accidental disconnection.
Component Rated input voltage Rated current[1] Rated frequency Rated power[2]
Genexus™ Integrated Sequencer 100–240 VAC 12–5A 50/60 Hz 1200W
[1] Based on rated current at minimum input voltage.
[2] Average power is 1000W.
A power cord is provided with the instrument. If the power cord is not suitable for installation in your
region, ensure that any power cord you do use is:
•Maximum 10ft (3m) in length
•Grounding type
•Compatible with the power supply receptacles used to connect to main power
•Suitable for the rating of the instrument and mains power supply
•Compliant with local safety requirements (for example, UL Listed for North America, JIS approved
for Japan, HAR or agency certified for Europe)
Site requirements
10 Genexus™ Integrated Sequencer Site Preparation Guide
Electrical protective devices
We recommend several protective devices to protect the system in environments with large voltage and
power fluctuations.
Device Description
Power line
regulator
We recommend the use of a 2.5-kVA power line regulator in areas where the supplied
power fluctuates in excess of ± 10% of the normal voltage. Power fluctuations can
adversely aect the function of the instrument and computer.
Note: A power line regulator monitors the input current and adjusts the power supplied
to the instrument or computer. It does not protect against a power surge or failure.
Uninterruptible
power supply
(UPS)
We recommend the use of a 2.5-kVA uninterruptible power supply (UPS), especially in
areas prone to power failure. Power failures and other events that abruptly terminate
the function of the instrument and computer can corrupt data and possibly damage the
system.
WARNING! PHYSICAL INJURY HAZARD. Do not attempt to lift the UPS unit
without assistance of at least two people. Improper lifting can cause painful
and permanent back injury. Refer to the UPS manufacturer user guide for more
information.
AVERTISSEMENT! RISQUE DE BLESSURES CORPORELLES. Ne pas es
sayer de soulever l’onduleur sans l’aide d’au moins deux personnes. En soule
vant incorrectement l’appareil, l’opérateur risque de se blesser au dos de façon
permanente. Voir le guide de l’utilisateur du fabricant de l’onduleur pour plus
d’informations.
IMPORTANT! UPSs provide power for a limited time. They are meant to delay the
eects of a power outage, not to serve as replacement power sources. In the event of a
power loss, power o the instrument and computer unless you expect to regain power
within the battery life of the UPS.
Surge protector We recommend the use of a 10-kVA surge protector (line conditioner) in areas with
frequent electrical storms or near devices that are electrically noisy, such as refrigerators,
air conditioners, or centrifuges. Short-duration, high-voltage power fluctuations can
abruptly terminate the function of, and thereby damage the components of, the
computer and the instrument.
Note: A dedicated line and ground between the instrument, computer, and the
building’s main electrical service can also prevent problems caused by power
fluctuations.
Site requirements
Genexus™ Integrated Sequencer Site Preparation Guide 11
Network requirements
The system is factory-configured for the TCP/IP protocol.
For the instrument to be connected to a LAN, an active, tested 1 GB LAN connection must be in place
before the scheduled installation date.
Network configuration
The following requirements must be met before installation of the instrument. Discuss any
discrepancies in the checklist with your field service representative before the visit.
•An information technologies resource must be available to assist with the network connection on
the date that the instrument will be installed.
•A static (or dynamic) IP address must be reserved for the instrument.
Note: If necessary, field service can provide the instrument's MAC address prior to the installation.
•The room where the instrument is deployed must contain at least one active 1 GB network jack.
•The site DNS Server must be configured for the instrument so that users can access the server
URL from their workstations.
•The instrument must be protected behind an appropriately configured network firewall and have
outbound internet access as described below.
Note: While not recommended, you can enable access to the instrument from the internet (via the
web server running on the Torrent Server). If you provide such access, you must restrict access
to the server using HTTP and AUTH firewall rules, or a combination of the two. Implementing and
maintaining such restrictions is the responsibility of the server administrator and not of Thermo
Fisher Scientific.
•The instrument requires outbound internet access through HTTP/port-80 to Connect at
apps.thermofisher.com to retrieve software updates.
Note: The instrument requires an ecient internet connection to download software updates. If
they are isolated from the internet, you must download and install updates manually to the server.
IMPORTANT! Manually installing server updates is not supported by Thermo Fisher Scientific.
If you choose to download the updates to a USB drive and manually update the internal server,
you do so at your own risk. Any issues updating the server in this manner requiring Thermo
Fisher Scientific intervention are not covered by the warranty or any service contract you may have
purchased. You will need to schedule an on-site visit by your field service engineer at your own
expense.
Site requirements
12 Genexus™ Integrated Sequencer Site Preparation Guide
•The instrument requires outbound internet access through HTTPS/port-443 and SSH/port-22 to
allow us to provide remote support via the Axeda Remote System Monitoring (RSM) Agent. The
server includes the Axeda Agent to assist you in maintaining your system and to provide timely
technical support.
IMPORTANT! Without access through HTTPS/port-443 and SSH/port-22, we cannot support your
site in a timely fashion and we may forego remote support for your site altogether at our discretion.
In addition, have port‑5000 and port‑9000 open and reserved for deep laser uploads, and port‑25
open and reserved for Simple Mail Transfer Protocol (SMTP).
Note: The Axeda Agent is already in use with other Ion Torrent™ sequencers to perform instrument
diagnostics, preventive maintenance, failure prediction, and proactive notification. The agent does
not collect any sequencing reports, results, or data.
•If the instrument is installed without a connection to a local area network, you must provide a router
to access data generated by the instrument. Connection and configuration of the router is not the
responsibility of the field service engineer.
Network and password security requirements
Network configuration and security
The network configuration and security settings (for example, firewalls, antivirus software, network
passwords) of your laboratory or facility are the sole responsibility of your facility administrators and
IT and security personnel. Genexus™ Software does not provide any network or security configuration
files, utilities, or instructions.
If external or network drives are connected to the sequencer, it is the responsibility of your IT personnel
to ensure that such drives are configured and secured correctly to prevent data corruption or loss.
Note: If a LIMS system is configured to retrieve files from the sequencer, you have the option to
manually set up an FTP directory or drive mapping. This configuration is not provided as part of
sequencer installation, and must be set up by your LIMS system integration or IT group.
Password security
Best practice is to maintain unique passwords for all accounts in use in Genexus™ Software. All
passwords must be reset the first time a user signs into the software. Change passwords according to
your organization's password policy.
It is the sole responsibility of your IT personnel to develop and enforce secure use of passwords.
This feature allows you to meet Title 21 CFR Part 11 of Federal Regulations that establishes the
United States Food and Drug Administration regulations on electronic records and signatures, password
policies, and user activity auditing.
Antivirus software
Thermo Fisher Scientific has tested Genexus™ Software with the following antivirus software products
and found them compatible as antivirus solutions:
•Bitdefender GravityZone™ Business Security
•Avast Antivirus
Site requirements
Genexus™ Integrated Sequencer Site Preparation Guide 13
Note: Antivirus Software definition files are updated frequently, sometimes daily. Definition file updates
for antivirus software can bring added settings or updates to the system which can aect the function
of Genexus™ Software.
Safety requirements
Safety practices
A safety representative from your facility must ensure that:
•Personnel establish and follow all applicable safety practices and policies to protect laboratory
personnel from potential hazards.
•All applicable safety devices and equipment are available at all times.
Required safety equipment
Your laboratory has specific safety practices and policies designed to protect laboratory personnel from
potential hazards that are present. Follow all applicable safety-related procedures at all times.
The following safety equipment and protection from hazards must be available at the installation site:
•Protection from any sources of hazardous chemicals, radiation (for example, lasers, radioisotopes,
radioactive wastes, and contaminated equipment), and potentially infectious biological material that
may be present in the area where the service representative will work.
•Eyewash
•Safety shower
•Eye and hand protection
•Adequate ventilation, including vent line/fume hood, if applicable
•Biohazard waste container, if applicable
•First-aid equipment
•Spill cleanup equipment
•Applicable Safety Data Sheets (SDSs)
Site requirements
14 Genexus™ Integrated Sequencer Site Preparation Guide
Materials for installation and operation
Installation kit
The Ion Torrent™ Genexus™ Installation and Training Kit (Cat. No. A40278) is available to first-time
owners of a Genexus™ Integrated Sequencer and is shipped with the instrument. The kit contains the
core reagents, supplies, and controls that are used during the installation, training, and operation of the
instrument.
Contents Part No. Quantity Storage
Genexus™ Controls A40267 1 kit −30°C to −10°C
Genexus™ Strip1 A46812 8 strips 2°C to 8°C
Genexus™ Strip2‑AS A46813 8 strips −30°C to −10°C
Genexus™ Barcodes 1–32AS A40258 1 plate 15°C to 30°C
Genexus™ Strip3‑GX5™A46815 8 strips 2°C to 8°C
Genexus™ Strip4 A46816 8 strips −30°C to −10°C
Genexus™ Cartridge A40272 2 cartridges −30°C to −10°C
Genexus™ Bottle 2 A40273 4 bottles
15°C to 30°C
Genexus™ Bottles 1 and 3 A40274 2 bottles each
Genexus™ Pipette Tips A40266 12 racks
Genexus™ Conical Bottles A40275 2 sets of 5 bottles
Genexus™ Filter A40302 1 filter
GX5™ Chip and Genexus™ Coupler A40269 2 each
Adhesive PCR Plate Foils AB0626 1 box (100 foils)
MicroAmp™ EnduraPlate™ Optical 96-Well Clear Reaction
Plates with Barcode
4483354 20 plates
Operation materials
Additional supplies and consumables are necessary for routine operation. Contact a sales
representative to order these additional supplies. Use only supplies as specified by Thermo Fisher
Scientific.
Materials for installation and operation
Genexus™ Integrated Sequencer Site Preparation Guide 15
Equipment required if using the Genexus™ Strip Centrifuge Adapter
If you are using the Genexus™ Strip Centrifuge Adapter to centrifuge library and templating reagent
strips before loading in the sequencer, you can use the following centrifuge, rotor, and buckets with
the adapter. Equipment that performs equivalently can also be used. Unless otherwise indicated, all
materials are available through thermofisher.com.
Item Source
Sorvall™ ST 8 Small Benchtop Centrifuge (or equivalent)[1] 75007200
Thermo Scientific™ M10 Microplate Swinging Bucket Rotor (or equivalent)[2] 75005706
Buckets for M10 Rotor; Capacity: 4 Standard or 2 Midi-Deepwell plates (Set of2) (or equivalent) 75005721
[1] Centrifuge must achieve an RCF of 2000 × g, have a swinging bucket rotor, and accommodate deepwell plates.
[2] Swinging bucket rotor must carry deepwell plates in the landscape orientation.
Receive and inspect the shipment
1. Verify that the items shown on the shipping list are the items that were ordered at the time of
purchase.
2. Carefully inspect the shipping containers. Report any damage to the shipping company and to
your service representative. Record any damage or mishandling on the shipping documents.
Note: The shipping crate is equipped with a "Tip-N-Tell" label to detect tipping during shipment.
Report the presence of blue beads in the arrow to your service representative.
3. Immediately unpack the reagents or installation kit box (boxed separately from the instrument
components). Store the reagents at the temperatures specified on the product packaging or labels.
IMPORTANT! Other than reagents or plates that require storage at specific conditions, do not unpack
shipping containers at this time. To protect yourself from liability for damage that occurred during
shipping, inspect the shipping containers and report damage as described above.
Receive and inspect the shipment
16 Genexus™ Integrated Sequencer Site Preparation Guide
Move the crated instrument to the installation site
1. Clear the installation site of all unnecessary materials.
2. If possible, move the crated instrument and other shipping containers to the installation site. Do
not uncrate.
Note: One side of the shipping crate serves as a ramp to roll the instrument from the crate pallet
to the floor. Eighteen linear feet (5.5 m) of clearance are required to uncrate the instrument using
the ramp. If the installation site does not have adequate space to deploy the ramp, leave the crated
instrument in a secure receiving area where there is sucient space.
CAUTION! PHYSICAL INJURY HAZARD. Do not attempt to lift or move the instrument without
the assistance of others, the use of appropriate moving equipment, and proper lifting techniques.
Improper lifting can cause painful and permanent back injury. Depending on the weight, moving or
lifting an instrument may require two or more people.
MISE EN GARDE! RISQUE DE BLESSURE PHYSIQUE. N’essayez pas de soulever ou de dépla
cer l’instrument sans l’aide d’autres personnes et sans utiliser les équipements de déplacement et
les techniques de levage adaptés. Un levage incorrect peut provoquer des lésions douloureuses et
permanentes du dos. Le levage ou le déplacement d’un instrument peut nécessiter deux personnes
ou plus, selon le poids.
IMPORTANT!
·Do not tip the crated instrument on end. Tipping can damage the instrument hardware and
electronics.
·After installation, retain the crate and instrument packaging if you need to relocate the instrument.
Move the crated instrument to the installation site
Genexus™ Integrated Sequencer Site Preparation Guide 17
Documentation and support
Related documentation
Document Pub. No. Description
Genexus™ Integrated
Sequencer User Guide
MAN0017910 Describes the Genexus™ Integrated Sequencer hardware and
software, and provides information on operating, maintaining, and
troubleshooting the instrument.
Genexus™ Integrated
Sequencer IT Checklist
MAN0018466 Describes the IT setup requirements for successful installation of
the Genexus™ Integrated Sequencer, and for eective support of the
instrument by Thermo Fisher Scientific.
Customer and technical support
Visit thermofisher.com/support for the latest service and support information.
•Worldwide contact telephone numbers
•Product support information
–Product FAQs
–Software, patches, and updates
–Training for many applications and instruments
•Order and web support
•Product documentation
–User guides, manuals, and protocols
–Certificates of Analysis
–Safety Data Sheets (SDSs; also known as MSDSs)
Note: For SDSs for reagents and chemicals from other manufacturers, contact the
manufacturer.
Thermo Fisher Scientific Concierge contact information
Contact your Thermo Fisher Scientific Concierge Team or your local Field Service Engineer (FSE) for
any questions you may have.
Location Support contact information
Americas AMER.Concierge@themofisher.com
Asia, Pacific, Japan APJ.Concierge@thermofisher.com
Europe, Middle East, Africa EMEA.Concierge@thermofisher.com
Other regions thermofisher.com/askaquestion
Documentation and support
18 Genexus™ Integrated Sequencer Site Preparation Guide
Limited product warranty
Life Technologies Corporation and/or its aliate(s) warrant their products as set forth in the
Life Technologies' General Terms and Conditions of Sale at www.thermofisher.com/us/en/home/
global/terms-and-conditions.html. If you have any questions, please contact Life Technologies at
www.thermofisher.com/support.
Documentation and support
Genexus™ Integrated Sequencer Site Preparation Guide 19
Life Technologies Holdings Pte Ltd |
Block 33 |
Marsiling Industrial Estate Road 3 |
#07-06, Singapore 739256
Products manufactured at this site:
Genexus™ Integrated Sequencer
For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.
Revision history:MAN0017918 G.0 (English)
Revision Date Description
G.0 1 June 2023 •Updated guidance for antivirus software. See “Antivirus software” on page13.
•Added Concierge contact information. See “Thermo Fisher Scientific Concierge contact information”
on page18
F.0 18 October 2022 •Updated shipping crate dimensions in “Crates and packages” on page4.
•Added information for centrifuge and rotor needed for the Genexus™ Strip Centrifuge Adapter.
•Updated guidance for antivirus software. See “Antivirus software” on page13.
E.0 12 April 2022 •Updated altitude limit and added a temperature limit when operating the sequencer at high altitude
in “Environmental requirements” on page7.
•Added rated power specification in “Electrical requirements” on page10.
D.0 3 November 2021 •Changed the acceptable range of operating conditions for humidity from 10%–80% to 20%–70% in
“Environmental requirements” on page7.
•Added guidance for antivirus software. See “Antivirus software” on page13.
C.0 18 May 2021 •Added operating temperature recommendation for install qualification and performance qualification
runs to “Environmental requirements” on page7.
•Updated “Network configuration” on page12.
B.0 30 June 2020 •Updated the Genexus™ Installation and Training Kit components.
•Added #unique_24/unique_24_Connect_42_GUID-9B934283-9E84-41C4-ACCA-CD6F060B43FE on
page8.
A.0 11 November 2019 New site preparation guide for the Genexus™ Integrated Sequencer
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL,
INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT,
INCLUDING YOUR USE OF IT.
Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these products, you accept the
terms and conditions of all applicable Limited Use Label Licenses.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Bitdefender GravityZone is a
trademark of Bitdefender IPR Management Ltd. Kaspersky is a trademark of Kaspersky Labs International.
©2019-2023 Thermo Fisher Scientific Inc. All rights reserved.
Genexus Integrated Sequencer_SPG_MAN0017918-v9-GUID-5E535C4D-9AE3-40BD-B66D-
CD16A35584BF-2022/11/29 16:43:38 en
16:34:49.604+01:00
thermofisher.com/support|thermofisher.com/askaquestion
thermofisher.com
1 June 2023
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Thermo Fisher Scientific Genexus Integrated Sequencer User guide

Brand
Thermo Fisher Scientific
Model
Genexus Integrated Sequencer
Type
User guide
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