Ellume LAB User Manual

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CONTENTS

INTRODUCTION .............................................................................................................................. 3

Intended Use .................................................................................................................................................. 3

Package Contents ........................................................................................................................................... 3

ellume·lab Layout ........................................................................................................................................... 3

Safety ............................................................................................................................................. 4

Universal Labels and Symbols ........................................................................................................................ 4

Warnings and Safety Precautions .................................................................................................................. 4

SET UP ............................................................................................................................................ 5

Initial Setup .................................................................................................................................................... 5

3.1.1

Accessing Settings .................................................................................................................................. 5

3.1.2

Wi-Fi Connection Setup ......................................................................................................................... 5

3.1.3

Setting Time Zone .................................................................................................................................. 6

3.1.4

Manually set Time Zone ......................................................................................................................... 6

Initial Charging ............................................................................................................................................... 6

Power On ....................................................................................................................................................... 6

Power Off ....................................................................................................................................................... 6

USER INTERFACE ............................................................................................................................ 6

Home Screen .................................................................................................................................................. 6

Indicator Icons ............................................................................................................................................... 7

PREPARATION FOR PATIENT/EXTERNAL QUALITY CONTROLS TEST .............................................. 7

PERFORMING TWO TESTs .............................................................................................................. 8

Previous Results ............................................................................................................................. 8

PREINSTALLED APPS ....................................................................................................................... 9

Instructions .................................................................................................................................................... 9

SETTINGS ........................................................................................................................................ 9

Screen Brightness ........................................................................................................................................... 9

Notification Volume ....................................................................................................................................... 9

Change Wi-Fi Connection ............................................................................................................................... 9

Modify System Date and/or Time ................................................................................................................ 10

About ........................................................................................................................................................... 10

10 MAINTENANCE AND CLEANING ................................................................................................... 10

Cleaning / Disinfecting ................................................................................................................................. 10

IFU002 Version 5.0 | 09

January 2020

ELLUME·LAB USER MANUAL

FOR

INVESTIGATIONAL PURPOSES

ellume·lab User Manual

ONLY

Page 1 of 11

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Summary of Contents for Ellume LAB

Page 1: Table Of Contents
INVESTIGATIONAL PURPOSES CONTENTS INTRODUCTION ..........................3 Intended Use ..............................3 Package Contents ............................3 ellume·lab Layout ............................3 Safety ............................. 4 Universal Labels and Symbols ........................4 Warnings and Safety Precautions ........................4 SET UP ............................5 Initial Setup ..............................5 3.1.1...
Page 2 Battery Charging ............................10 10.2.1 Charging Cradle ............................ 10 10.2.2 ellume·lab Charging Port ........................10 11 APPENDIX ............................. 11 Technical Specifications ..........................11 Troubleshooting ............................11 11.2.1 Restarting ............................. 11 11.2.2 General Complaints or Technical Problems ..................11 11.2.3 Ordering ............................... 11 12 CONTACT ............................
Page 3: Introduction
Intended Use The ellume·lab is a handheld digital 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 tests. Each ellume·lab test is able to detect specific markers of common infectious and non-infectious conditions, e.g.
Page 4: Safety
The ellume·lab is designed to ensure safe and reliable operation, when used in accordance with this User Manual. If the ellume·lab is used in ways other than specified in this manual, safety of the operator and reliability of results may be compromised. All warnings and precautions must be followed to avoid personal injury or damage to the device.
Page 5: Set Up
• The ellume·lab may influence the surrounding environment due to its Wi-Fi connectivity • The ellume·lab has been validated for use of up to 5000 insertions per testing port. Do not use the device for more than the recommended number of insertions •...
Page 6: Setting Time Zone
Enter password (if required). d. Press Save. 5. The ellume·lab should now be connected to the new Wi-Fi network. This can be confirmed by checking that in the list of networks the Wi-Fi ON icon (Section 4.2) is next to the network name.
Page 7: Indicator Icons
Across the top of all screens are indicator icons for Wi-Fi and battery status. The Wi-Fi icon indicates whether the ellume·lab is connected to a wireless network. The battery status icon indicates what level of charge remains in the battery and whether the ellume·lab is charging.
Page 8: Performing Two Tests
The eStick must be used within 60 minutes from insertion into the ellume·lab. eStick will be voided if no sample is loaded within 60 minutes from insertion. Keep the ellume·lab horizontal while test is in progress. Rotating the device while performing a test will prompt a warning message.
Page 9: Preinstalled Apps
8 PREINSTALLED APPS Instructions The Instructions app contains all instructional material for the ellume·lab Tests, including Information Videos, Instructions for Use, and Quick Reference Instructions. The Instructions app can be opened by pressing the Instructions icon (Figure 8) on the home screen (Figure 2).
Page 10: Modify System Date And/Or Time
Cleaning / Disinfecting The ellume·lab should be cleaned after each use, each time a test is processed and after the device has been handled. Clean by rubbing by hand each surface for at least 30 seconds using disinfection wipes soaked in isopropyl alcohol (70% minimum), or by utilizing off-the-shelf wipes.
Page 11 Troubleshooting Restarting If the ellume·lab device is unresponsive, press and hold the Power button (Figure 1) for more than 7 seconds to force the ellume·lab to power off. Press the Power button again to turn on the device. General Complaints or Technical Problems Call the Ellume helpline or go online via www.ellumelab.com.
Page 12 FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.