SBM IDRA User Manual Download Page 2

2

INTRODUCTION 

SYMBOLS 

4

CARES, WARNINGS AND GENERAL SAFETY ADVICES 

 

Ordinary maintenance 

 

Transport, storage conditions and terms of use 

THE INSTRUMENT 

6  

 

Spare parts 

6  

 Accessories 

7  

 

Supply package 

SOFTWARE ICP USER MANUAL 

8  

 

Software installation 

8  

 

First use 

10 

GUIDE OF USE 

10  

 

Functional features 

10 

MAIN USE 

11 

HOME SCREEN 

12  

 

Create a new patient 

12  

 

New exam 

13 

MAIN EXAMS 

14 

ADDITIONAL EXAMINATIONS 

15 

 Pupillometry 

16 

GENERIC EXAM 

18  

EXAMS LIST 

19  

 

Display exams related to a patient 

19  

 

Type of saved exams 

19 

BUTTONS 

20 

TROUBLESHOOTING 

21 

TECHNICAL AND ELECTRICAL FEATURES 

21 

 

Minimum hardware requirements 

22 

TEST RESULTS 

22  

 

Measurement of emission 

22  

 

Radiated Emission Peak 

23  

 

Immunity test 

24  

 

Radiated Electromagnetic Immunity 

24  

 

Immunity to RF wireless communication equipment 

25  

 

Power frequency magnetic fields immunity test 

26 

SUMMARY OF TESTS RESULTS 

26 

SETTINGS 

27 

 

Using ICP as a viewer 

29

DISPOSAL POLICY 

30 

LIABILITY 

30

WARRANTY AND CONTACTS 

31

CERTIFICATION AND DECLARATION OF CONFORMITY 

31

INDEX

Summary of Contents for IDRA

Page 1: ...User Manual IDRA...

Page 2: ...15 Pupillometry 16 GENERIC EXAM 18 EXAMS LIST 19 Display exams related to a patient 19 Type of saved exams 19 BUTTONS 20 TROUBLESHOOTING 21 TECHNICAL AND ELECTRICAL FEATURES 21 Minimum hardware requir...

Page 3: ...video or using the voice TearMeniscus through the automatic centering of the device it allows to measure the quantity of aqueous layer in millimeters and to save the value NIBUT recording a video it...

Page 4: ...pose Keep away from moisture Manufacturer info according to Directive 93 42 EEC and subsequent amendments Device number reference Device serial number Handle with care Upward Fragile Transport and sto...

Page 5: ...er source The device must not touch the patient A long exposure to strong light can damage the retina the use of the device for ocular examination must not last unnecessarily Assistance If you encount...

Page 6: ...ative humidity between 10 and 90 The environmental terms of use are as follows Temperature between 15 C and 45 C Atmospheric pressure between 700 hPa and 1060 hPa relative humidity between 30 and 75 T...

Page 7: ...upport applicable to the working table Suitcase to store the device to protect and transport it Supply package The instrument is delivered in a packaging In the suitcase are inserted required accessor...

Page 8: ...stallation of the software files through the Setup provided by the supplier 1 Execute Setup file 2 Start the software to download the ICP application on the PC 3 Wait for the end of procedure 4 Wait f...

Page 9: ...ion provided by your supplier or enter the code if provided by the same Data protection code Fig 2 For added security you can set a code that you enter each time you sign in the application or wake up...

Page 10: ...be kept as close as possible to the eye without touching Closer is the device to the eye broader is the area lighted by the instrument The light reflected from the tear film can be observed as a whit...

Page 11: ...erved with IDRA presents with a typical black line near the convex part of the meniscus profile Tear film stability and regularity IDRA allows to evaluate stability and regularity of the tear film usi...

Page 12: ...Pupillometry let you know which the values of pupillometry are in scotopic mesopic and photopic vision done with the IDRA Warning by pressing any delete button will lost your data in a permanent and...

Page 13: ...ture of the patient through the button In addition you can add any information about the patient s exam New exam Tapping New Exam button on the top it is possible to start a new screening exam for the...

Page 14: ...record a good video go on focus on the iris moving the base and then move backward of 2mm to focus properly on the LIPID LAYER the iris will be not on focus The circle of light has to be around 5mm it...

Page 15: ...tion At the end of the procedure will be shown the image with the lids and glands area highlighted with red and green color Fig 12 1 Now you can save the measure to return on the exams screen ADDITION...

Page 16: ...tic led adjustment A summary of this collected results is accessible on the bottom of the main screen Pupillometry Fig 15 Demodex Fig 14 To take a picture and do this exam you need you need to remove...

Page 17: ...PHOTOPIC light will switch on Follow instructions as in point 1 Now it s possible to evaluate the acquisitions following the instructions on the left 1 with the first acquisition you obtain the pupil...

Page 18: ...device such as a digital slit lamp to study the anterior ocular segment It is possible to record videos take pictures and choose the kind of lighting After doing generic exam for example to analyse bu...

Page 19: ...the bottom there are play pause full screen view compare result and processing of the selected video while on the right there are buttons to do a screenshot by the video and evaluate the tear meniscu...

Page 20: ...lly ISO Button Tap ISO or ISO to manually manage the light exposure of the device camera Auto Focus Button The Auto Focus button allows to obtain and maintain automatically focus on a subject Focus Bu...

Page 21: ...easure meniscus PROBLEM Not working or switched off led Turned off camera black screen REMEDY In case of protracted use system goes on energy saving mode If it happens close and restart the acquisitio...

Page 22: ...pply Voltage Device Operating Voltage 2 cm 6 cm by ocular surface USB 2 0 e USB 3 0 B connector IEC 60601 1 2 2015 5 V 5 V TEST RESULTS Measurement of emission Measurement of radiated emission Referen...

Page 23: ...23 Radiated emission peak...

Page 24: ...Reference document Test Level Test Equipment Environmental Conditions Uncertainty EN 61000 4 3 10V m modulated AM 80 1kHz Generator Rhode Schwarz SM300 Amplifier Kalmus 737FC Frankonia Amplifier FLG3...

Page 25: ...2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 EN 60601 1 2 Immunity to rf wireless communication equipment Reference document Test level Te...

Page 26: ...summarizes the tests performed Port Enclosure Enclosure Enclosure Enclosure Enclosure Frequency range MHz 30 1000 80 2700 See point 6 2 3 0 00005 Test Level Class B 15KV air 8KV contact 3V m modulated...

Page 27: ...n your PC Moreover it is possible to choose the language App Pass Code see p 9 Example Exams allows to download some photos and videos to show different situations Video settings in case the videos we...

Page 28: ...use ICP as a viewer to open a database located on the local network please read Using ICP as a Viewer section below Instruments section gives you technical information of the hardware Company is used...

Page 29: ...twork drive is mapped you can configure ICP to use it From the ICP main screen press Settings button to open settings panel In settings section press Database button to view database settings In the D...

Page 30: ...with Directive 2012 19 EU must be requested by sending an email to info sbmsistemi com Severe administrative sanctions available under the law in force for offenders 2018 SBM Sistemi S r l All rights...

Page 31: ...mage suffered in the period of disuse To obtain technical maintenance contact a technical support center or directly refer to SBM SISTEMI S r l Strada Torino 43 10043 Orbassano Torino Italy 0039 011 1...

Page 32: ...www sbmsistemi com Strada Torino 43 10043 Orbassano Torino Italy Tel 39 011 19923378 info sbmsistemi com...

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