ELLUME·LAB ·lab Covid Antigen

User Manual - Page 6

For ELLUME·LAB.

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6 ellume·lab User Manual
Minimizetheriskofinfectionfromcontactwiththeellume·lab:
The ellume·lab requires cleaning after every test or potential contact with
infectious substances. See Section 14 ‘Maintenance and Cleaning’ for cleaning
procedures.
Minimizetheriskofcontaminationoftheellume·lab:
Consider and treat all patient samples as infectious/biohazardous material.
Dispose of specimens and patient samples in accordance with federal, state,
and local requirements.
Clean the ellume·lab as per Section 14 ‘Maintenance and Cleaning’ prior to use,
storage, transport, or disposal.
• Ensureyouhavereceivedspecictraininginspecimencollectionandhandling
procedures before using the ellume·lab.
Wear appropriate personal protective equipment (PPE) including gloves,
protective clothing and eye protection when handling patient samples.
Otherprecautionsandadditionalinformation:
• The ellume·lab may inuencethesurroundingenvironment due to itsWi-Fi
connectivity.
The ellume·lab has been validated for use of up to 5000 eStick insertions per
testing port. Do not use the device for more than the recommended number
of eStick insertions.
The device is designed in accordance with international electrical safety
standards (IEC 61010-1, IEC 61010-2-101, and IEC 60601-1-2). This equipment has
been designed and tested to CISPR11 Class B.
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following conditions:
1. This device may not cause interference; and
2. This device must accept any interference, including interference that may
cause undesired operation of the device
3. This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiate radio
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