User's Manual

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IFU002 Version 5.0 | 09

January 2020 ellume·lab User Manual Page 1 of 11

CONTENTS

1 INTRODUCTION .............................................................................................................................. 3

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

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

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

2 Safety ............................................................................................................................................. 4

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

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

3 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

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

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

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

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

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

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

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

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

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

ELLUME·LAB USER MANUAL

FOR INVESTIGATIONAL PURPOSES ONLY

Summary of content (12 pages)

PAGE 1
ELLUME·LAB USER MANUAL FOR INVESTIGATIONAL PURPOSES ONLY CONTENTS 1 INTRODUCTION .............................................................................................................................. 3 Intended Use .................................................................................................................................................. 3 Package Contents..........................................................................................................................
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Battery Charging .......................................................................................................................................... 10 10.2.1 Charging Cradle .................................................................................................................................... 10 10.2.2 ellume·lab Charging Port...................................................................................................................... 10 11 APPENDIX .........................
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1 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. Group A Streptococcus, Influenza A+B, RSV etc. For test specific information, refer to the package inserts supplied with each test kit carton.
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2 SAFETY Universal Labels and Symbols Manufacturer Date of manufacture In vitro diagnostic medical device Biological risks Consult instructions for use Regulatory Compliance Mark (RCM) Catalogue Number CAUTION Consult accompanying documents. WARNING Indicates a hazardous situation, which if not avoided, could result in injury to the operator (e.g.
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Minimise the risk of infection from contact with the ellume·lab: • The ellume·lab requires cleaning after every test procedure or potential contact with infectious substances. Please refer to Section 10 ‘Maintenance and Cleaning’ for cleaning procedures • Clean the device using disinfecting wipes containing isopropyl alcohol (70% minimum). Off-the-shelf wipes (MEDI-9 Wipes, Clinell Wipes) have been validating for effective cleaning of the ellume·lab.
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4. Select the preferred Wi-Fi network from the list and enter the password (if required). If the preferred Wi-Fi network is not in the list, it can be manually added by select +Add network. a. Input the Wi-Fi network name (SSID). b. Select the security type. c. 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. 6.
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Figure 2 - Home Screen 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. The battery status icon will turn red when there is less than 40% battery charge left and if not connected to charging.
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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. The ellume·lab will notify the user if the eStick is exposed to unsuitable lighting conditions. Remove the ellume·lab and eStick from fluctuating light sources if a warning is displayed.
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Site/Pateint ID number Site/Control ID number Date test performed Time test performed LOT number Unique eStick ID number Figure 7 – Result Legend Figure 5 - Previous Results (Patients) Figure 6 - Previous Results (Controls) 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.
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5. 6. c. Enter password (if required). d. Press Save. 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. Press the Wi-Fi back button in the top left hand corner to return to the Settings menu. Modify System Date and/or Time It is recommended that Automatic Date & Time be set to Use network-provided time.
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APPENDIX Technical Specifications Dimensions Weight Power Supply Input Display Operating environment Shipping Storage 185 x 103 x 31 mm 390 g 100 ~ 240 VAC ; 50 ~ 60 Hz 6.95 inch diagonal – Touch screen 15°C – 35°C, 20% - 90% RH (non-condensing) -20°C – 40°C, 10% - 90% RH (non-condensing) 5°C - 35°C 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.
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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.