illumina NextSeq 550Dx Installation and operating manual

This guide provides important safety information
pertaining to the installation, servicing, and operation of
the Illumina®NextSeq™550Dx instrument. This guide
includes product compliance and regulatory statements.
Read this document before performing any procedures on
the instrument.
The country of origin and date of manufacture of the
system are printed on the instrument label.
Safety Considerations and Markings
This section identifies potential hazards associated with
installing, servicing, and operating the instrument. Do not
operate or interact with the instrument in a manner that
exposes you to any of these dangers.
All of the hazards described herein can be avoided by
following the standard operating procedures included in
the NextSeq 550Dx Instrument Reference Guide
(document # 1000000009513) .
General Safety Warnings
Make sure that all personnel are trained in the correct
operation of the instrument and any potential safety
considerations.
Follow all operating instructions when
working in areas marked with this label
to minimize risk to personnel or the
instrument.
Laser Safety Warning
The NextSeq 550Dx instrument is a
Class 1 laser product embedded with a
Class 3B diode. Class 1 levels of
radiation are not considered hazardous.
All laser radiation accessible to the
operator is in accordance with IEC
60825-1 accessible limits for Class 1
laser products.
Electrical Safety Warnings
Do not remove the outer panels from the instrument.
There are no user-serviceable components inside.
Operating the instrument with any of the panels removed
creates potential exposure to line voltage and DC
voltages.
The instrument is powered by 100–240
volts AC operating at 50–60 Hz.
Hazardous voltage sources are located
behind the rear and left side panel, but
can be accessible if other panels are
removed. Some voltage is present on
the instrument even when the instrument
is turned off. Operate the instrument
with all panels intact to avoid electrical
shock.
Power Specifications
Type Specification
Line Voltage 100–240 Volts AC @ 50/60Hz
Power Supply Rating 600Watts, maximum
Electrical Connections
Connect the instrument to a grounded circuit capable of
delivering at least:
u15 Amps for a 100–110 Volt power source
u10 Amps for a 220–240 Volt power source
For more information, see the NextSeq 550Dx Instrument
Site Prep Guide (document # 1000000009869) .
Protective Earth
The instrument has a connection to
protective earth through the enclosure. The
safety ground on the power cord returns
protective earth to a safe reference. The
protective earth connection on the power
cord must be in good working condition
when using this device.
Fuses
The instrument contains no user-replaceable fuses.
FOR IN VITRO DIAGNOSTIC USE
Document # 1000000009868 v01
NextSeq 550Dx
Instrument Safety and Compliance Guide

Hot Surface Safety Warning
Do not operate the instrument with any
of the panels removed.
Do not touch the temperature station in
the flow cell compartment. The heater
used in this area is normally controlled
between ambient room temperature
(22°C) and 95°C. Exposure to
temperatures at the upper end of this
range can result in burns.
Heavy Object Safety Warning
The instrument weighs approximately 86
kg (184 lb) and can cause serious injury
if dropped or mishandled.
Mechanical Safety Warning
Keep fingers away from syringes inside
the reagent compartment while the
instrument pump is running.
Uncrating, Installing, and Moving the Instrument
Only personnel authorized by Illumina can uncrate, install,
or move the instrument. If you must relocate the
instrument, contact your Illumina representative.
Environmental Considerations
Element Specification
Temperature Transportation and Storage: -10°C to
50°C (14°F to 122°F).
Operating Conditions: Maintain a lab
temperature of 19°C to 25°C (22°C
±3°C). This temperature is the
operating temperature of the
instrument. During a run, do not allow
the ambient temperature to vary more
than ±2°C.
Humidity Transportation and Storage: Non-
condensing humidity between 15-80%.
Operating Conditions: Maintain a
noncondensing relative humidity
between 20–80%.
Elevation Locate the instrument at an altitude
below 2000 meters (6500 feet).
Air Quality Operate the instrument in a Pollution
DegreeII environment or better. A
Pollution DegreeII environment is
defined as an environment that
normally includes only nonconductive
pollutants.
Ventilation Consult your facilities department for
ventilation requirements based on the
instrument heat output specifications.
Symbols
For in vitro diagnostic use
European Representative
Manufactured By
Date of Manufacture
Model Number
Serial Number
Off
On
Humidity Range (on packaging:
indicates acceptable shipping and
storage limits)
Temperature Range (on packaging:
indicates acceptable shipping and
storage limits)
Consult the Instructions for Use
Product Compliance and Regulatory Statements
Simplified Declaration of Conformity
Illumina, Inc. hereby declares that the NextSeq 550Dx
instrument is in compliance with the following Directives:
uEMC Directive [2014/30/EU]
uLow Voltage Directive [2014/35/EU]
uRED Directive [2014/53/EU]
The full text of the EU Declaration of Conformity is
available at the following internet address:
support.illumina.com/certificates.html.
Restriction of Hazardous Substances (RoHS)
This label indicates that the instrument
meets the WEEE Directive for waste.
Visit support.illumina.com/certificates.html
for guidance on recycling your equipment.
NextSeq 550Dx Instrument Safety and Compliance Guide
Document # 1000000009868 v01

Human Exposure to Radio Frequency
This equipment complies with maximum permissible
exposure (MPE) limits for the general population per Title
47 CFR § 1.1310 Table 1.
This equipment complies with the limitation of human
exposure to electromagnetic fields (EMFs) for devices
operating within the frequency range 0 Hz to 10 GHz,
used in radio frequency identification (RFID) in an
occupational or professional environment. (EN
50364:2010 sections 4.0.)
For information on RFID compliance, see the RFID
Reader Module Compliance Guide (document #
1000000030332) .
FCC Compliance
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following 2 conditions:
1 This device may not cause harmful interference.
2 This device must accept any interference received,
including interference that may cause undesired
operation.
CAUTION
Changes or modifications to this unit not expressly
approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
NOTE
This equipment has been tested and found to comply with
the limits 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 a commercial environment.
This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in
accordance with the instrumentation manual, may cause
harmful interference to radio communications. Operation
of this equipment in a residential area is likely to cause
harmful interference in which case users will be required
to correct the interference at their own expense.
Shielded Cables
Shielded cables must be used with this unit to ensure
compliance with the Class A FCC limits.
EMC Considerations
This IVD equipment complies with the emission and
immunity requirements described in IEC 61326-2-6.
This equipment has been designed and tested to the
CISPR 11 Class A standard. In a domestic environment it
may cause radio interference, in which case, you may
need to take measures to mitigate the interference.
Do not use the device in close proximity to sources of
strong electromagnetic radiation, as these can interfere
with proper operation.
Evaluate the electromagnetic environment before
operation of the device.
IC Compliance
This Class A digital apparatus meets all requirements of
the Canadian Interference‐Causing Equipment
Regulations.
This device complies with Industry Canada license‐
exempt RSS standards. Operation is subject to the
following 2 conditions:
1 This device may not cause interference.
2 This device must accept any interference, including
interference that may cause undesired operation of
the device.
Korea Compliance
해당무선설비는운용중전파혼신가능성이있음.
A급기기(업무용방송통신기자재)
이기기는업무용(A급)으로전자파적합로서판매
자또는사용자는이점을주의
하시기바라며,가정외의지역에서사용하는것을
목적으로합니다.
NextSeq 550Dx Instrument Safety and Compliance Guide
Document # 1000000009868 v01

Revision History
Document Date Description of Change
Document #
1000000009868
v01
August
2018
Updated regulatory markings.
Document #
1000000009868
v00
November
2017
Initial release.
Copyright and Trademarks
© 2018 Illumina, Inc. All rights reserved.All trademarks are the property
of Illumina, Inc. or their respective owners. For specific trademark
information, see www.illumina.com/company/legal.html.
Contact Information
Illumina
5200 Illumina Way
San Diego, California
92122 U.S.A.
+1.800.809.ILMN (4566)
+1.858.202.4566 (outside
North America)
[e-mail]
www.illumina.com
Illumina Cambridge
Limited
Chesterford Research
Park, Little Chesterford
Saffron Walden, CB10 1XL
UNITED KINGDOM
Australian Sponsor
Illumina Australia Pty Ltd
1 International Court
Scoresby, Victoria, 3179
Australia
NextSeq 550Dx Instrument Safety and Compliance Guide
Document # 1000000009868 v01