Illumina NextSeq 500 and NextSeq 550 Sequencing Systems Safety and Compliance Guide

Introduction

This guide provides essential safety information for the installation, servicing, and operation of Illumina® NextSeq® 500 and NextSeq® 550 systems. It also includes product compliance and regulatory statements. Read this document before performing any procedures on the system.

Safety Precautions and Markings

General Safety Warnings

Ensure all personnel are trained in proper instrument operation and potential safety precautions. Use caution in marked areas.

⚠️ In areas marked with this symbol, follow all operating instructions to minimize risks to personnel or the instrument.

Laser Safety Warnings

NextSeq systems are Class 1 laser products incorporating a Class 3B diode. Class 1 radiation is not considered hazardous. All laser radiation emitted towards the operator complies with the IEC 60825-1 limits for Class 1 laser products.

Electrical Safety Warnings

Do not remove external panels. The instrument contains no user-serviceable parts. Removing any panel may expose you to line voltage and DC voltage, posing a shock hazard. The instrument is powered by 100-240 VAC at 50-60 Hz. Hazardous voltage sources are located behind the rear and left-side panels, but may be accessible if other panels are removed. Voltage may be present even when the instrument is off. Operate the instrument with all panels intact to prevent electric shock.

Protective Grounding

The instrument is protected by its chassis, which is connected to protective earth. The safety ground of the power cord connects the protective earth to a safe reference potential. The protective earth connection of the power cord must be in good working order when using this device.

Fuses

This instrument does not contain user-replaceable fuses.

Surface High Temperature Warning

Do not operate the instrument with any panels removed. Do not touch the temperature stations in the flow cell. The heaters in this area typically control temperatures between ambient room temperature (22°C) and 95°C. High temperatures can cause burns. ?

Heavy Object Safety Warning

The instrument weighs approximately 83 kg (183 lbs). Dropping or improper handling can cause serious injury. ⚠️

Mechanical Safety Warnings

Do not touch the syringe in the reagent cartridge while the instrument pump is running. ⚠️

Unpacking, Installation, and Moving

Only authorized Illumina personnel are permitted to unpack, install, or move the instrument. For relocation, please contact your Illumina representative.

Environmental Considerations

Factor	Specification
Temperature	Maintain laboratory temperature between 19°C and 25°C (22°C ±3°C). This is the operating temperature. Ambient temperature fluctuations must not exceed ±2°C during operation.
Humidity	Maintain relative non-condensing humidity between 20-80%.
Altitude	Operate at altitudes below 2000 meters (6500 feet).
Air Quality	Operate in a Class 9 (General Laboratory Grade) or better cleanroom environment (ISO 14644-1). Keep the instrument away from dust sources.
Ventilation	Consult facilities for ventilation requirements based on instrument heat output specifications.
Vibration	Continuous vibration on laboratory floors should be limited to ISO office-grade levels. Do not exceed ISO operating room-grade limits during sequencing runs. Avoid intermittent vibration or disturbances near the instrument.

Specifications

Electrical Specifications

Type	Specification
Line Voltage	100-240 VAC, 50/60 Hz
Power Rating	Max 600 W

Electrical Connection

Connect the instrument to a grounded circuit capable of supplying at least:

15 Amps (for 100-110 V power)
10 Amps (for 220-240 V power)

For details, refer to the "NextSeq System Site Preparation Guide" (Document No. 15045113).

Regulatory Compliance

Simplified Compliance Statement

Illumina, Inc. hereby declares that the NextSeq 500 complies with the following directives:

EMC Directive [2014/30/EU]
Low Voltage Directive [2014/35/EU]
RED Directive [2014/53/EU]

For the full EU Declaration of Conformity, visit: support.illumina.com/certificates.html.

Compliance and Regulatory Markings

This instrument bears the following compliance and regulatory marks:

NRTL Mark: This label certifies that the product has been tested and certified by TUV Rheinland (a US nationally recognized testing laboratory).
CE Mark: This label certifies that the product meets the basic requirements of all relevant EU directives.
10-Year Symbol: This label certifies that the product meets the environmental use period – 10 years.

Hazardous Substances Directive (RoHS)

This label indicates that the instrument complies with the WEEE directive. Visit support.illumina.com/certificates.html for information on equipment recycling.

Radiation Exposure

This device complies with the General Population/Uncontrolled Exposure limits specified in 47 CFR § 1.1310 Table 1 (MPE). This device complies with the limits for human exposure to electromagnetic fields (EMF) for devices operating in the 0 Hz to 10 GHz frequency range, intended for occupational or professional environments (EN 50364:2010 Section 4.0).

FCC Compliance

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired operation.

Shielded Cables

Shielded cables must be used to ensure compliance with FCC Class A digital device limits.

Note: Changes or modifications to this device 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 in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be responsible for correcting the interference at their own expense.

IC Compliance

This Class A digital apparatus complies with Canadian Interference-Causing Equipment Regulations.

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions:

This device may not cause interference.
This device must accept any interference, including interference that may cause undesired operation of the device.

Korean Regulatory Compliance

This radio equipment may cause radio interference during operation. This is a Class A device (Business-use Radio Communication Equipment). Users should be aware of this and use it outside of residential areas.

Revision History

Document No.	Date	Revision Description
15046564 v03	March 2020	Removed "Compliance and Regulatory Markings" section. Updated "Class A EMC Compliance" section title to "Korean Regulatory Compliance". Updated title to specify NextSeq 500 and NextSeq 550.
15046564 v02	March 2016	Corrected product certification list to UL 61010-1:2012. Removed Peltier effect description from heater type.
15046564 v01	October 2015	Added Arabic translation. Added French, German, Italian, Korean, Portuguese, Russian, Simplified Chinese, and Spanish translations.
15046564 B	May 2015	Title changed to "NextSeq System Safety and Compliance Guide". This guide applies to NextSeq 500 and NextSeq 550 systems.
15046564 A	December 2013	Initial release.

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