Ellume ELLUME·LAB User Manual

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8 ellume·lab User Manual

4 Introduction

4.1 Intended Use

The ellume·lab is a handheld digital diagnostic device intended for use by

healthcare professionals at the point of care. It is used in combination with the

ellume·labsuiteofrapidinvitrodiagnostic(IVD)teststodetectspecicmarkersof

infectiousdiseases.PleaserefertotheIVD-specicInstructionsForUseprovided

with each authorized test kit for details of their intended use.

The ellume∙lab alsoprovides educational contentanddigitalservices througha

wide range of applications.

4.2 PackageContents

The ellume·lab product box contains:

• 1 x ellume·lab

• 1 x charging adapter

• 1 x ellume·lab USB charging cable

• 1 x User Manual

• 1 x Quick Start Guide

Checktheellume·labpackagecontentstoconrmallcontentsareincludedand

have no signs of damage or defects. Use the ellume·lab with approved ellume·lab

tests only. Using non-approved test cartridges, test kit components, chargers,

cables, and accessories will impact on device function and void warranty.

Please contact the Ellume Customer Support on 1-888-919-0779 for all inquiries.

Additionalinformationcanbefoundatwww.ellumelab.com.

4.2.1 ellume∙labAccessories

The accessories (charging cable and charging adapter) supplied are for use with

the ellume·lab only and may vary depending on region. Do not use ellume∙lab

accessories with other medical or electronic devices.

4.3 Calibration and Quality Control (QC)

4.3.1 ellume∙lab

The ellume∙lab does not require calibration from the user. When an eStick is

inserted, it automatically performs a series of self-tests and calibration checks.

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ELLUME·LAB ·lab Covid Antigen