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5.2.1

Responsibility of the manufacturer

The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:

•

All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment man-
ufacturer or personnel authorized by the manufacturer.

•

The electrical installation to which the equipment is connected complies with EN/IEC requirements.

•

The equipment is used in accordance with the instructions for use.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of
equipment serviced or repaired by other parties.

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Otometrics - AURICAL OTOcam 300

5 AURICAL OTOcam 300 video otoscope standards and safety

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Summary of Contents for AURICAL OTOCAM 300

Page 1: ...AURICAL OTOcam 300 and the Video Otoscopy Module Reference Manual Doc No 7 50 1340 EN 06 Part No 7 50 13400 EN ...

Page 2: ...ometrics the Otometrics Icon AURICAL MADSEN Otoscan ICS and HORTMANN are registered trademarks of GN Otometrics A S in the U S A and or other countries Version release date 2018 12 06 204106 Technical support Please contact your supplier Otometrics AURICAL OTOcam 300 2 ...

Page 3: ... Capture functions 12 3 6 2 Capturing a picture 13 3 6 3 Switching modes with AURICAL OTOcam 300 14 3 7 Edit mode 14 3 7 1 Right click functions 15 3 7 2 Adding markers to a picture 16 3 7 3 Removing markers 16 3 7 4 Adding comments to a picture 17 3 7 5 Assigning a picture to the other ear 17 3 8 Deleting pictures 17 3 9 Copying pictures to the clipboard 17 3 10 Exporting pictures 18 3 11 Live Ot...

Page 4: ...App 1 2 Device 25 App 1 3 Notes on EMC Electromagnetic Compatibility 28 Index 33 4 Otometrics AURICAL OTOcam 300 ...

Page 5: ...RICAL OTOcam 300 is intended for use in connection with the OTOsuite Video Otoscopy module to visually inspect the ear canal and the tympanic membrane and to capture and store pictures of the ear canal and the tympanic membrane or other such applications performed by audiologists hearing instrument dispensers ENT doctors and other trained per sonnel Please note that local regulations may define us...

Page 6: ... AURICAL OTOcam 300 video otoscope standards and safety 22 1 3 Typographical conventions The use of Warning Caution and Note To draw your attention to information regarding safe and appropriate use of the device or software the manual uses pre cautionary statements as follows Warning Indicates that there is a risk of death or serious injury to the user or patient Caution Indicates that there is a ...

Page 7: ...to keep the packing material in which they were delivered If you need to send AURICAL OTOcam 300 in for service the original packing material will protect against damage during transport etc 2 Inspect the equipment for possible visual damage If damage has occurred do not put the device into operation Contact your local distributor for assistance 3 Check the packing list accompanying the package to...

Page 8: ...te and select the OTOsuite Video Otoscopy module AURICAL OTOcam 300 is automatically connected to the OTOsuite Video Otoscopy module 2 5 Switching AURICAL OTOcam 300 on and off Switching on AURICAL OTOcam 300 1 Start up the computer 2 Connect the USB cable of AURICAL OTOcam 300 to one of the computer s USB ports 3 Launch OTOsuite and select the Video Otoscopy module If OTOcam 300 is not placed in ...

Page 9: ...ms In most cases the camera tip has a lower temperature than the air in the ear canal This causes condensation which reduces the image quality In AURICAL OTOcam 300 the built in heater pre heats the camera tip so that the temperature difference between the camera tip and the air inside the ear canal is minimal The pre heating function is activated when the AURICAL OTOcam 300 is plugged into the PC...

Page 10: ...iques The lighted camera allows a full view of the area to be cleaned If you use a cerumen removal speculum it may not be necessary to apply any fluids in the ear canal This makes the speculum approach useful and effective even for cases with PE tubes and for other situations where the tympanic membrane is not intact 3 3 Preparing for a session with a client 1 Connect AURICAL OTOcam 300 to the PC ...

Page 11: ...correct path 3 5 The main window The Video Otoscopy screen is divided into three main sections Before capturing pictures If AURICAL OTOcam 300 is connected the Video Otoscopy module opens up showing a live image A Left Picture Panel B Main work area C Right Picture Panel As default the left Picture Panel is shown to the left of the screen If you want to switch the right Picture Panel to the left s...

Page 12: ...ually inspect and capture pictures of the ear canal the tympanic membrane or other such applications 3 6 1 Capture functions The Capture toolbar Delete All Pictures Deletes all pictures captured in this session Icon AURICAL OTOcam 300 Shortcut Capture L Captures the picture as Left Ear R Captures the picture as Right Ear 12 Otometrics AURICAL OTOcam 300 3 Capturing and editing pictures ...

Page 13: ... the Spacebar to freeze the image 2 When a satisfactory image is obtained press the Right Ear or Left Ear button on OTOcam 300 to capture the image 3 If needed press the Spacebar to unfreeze the image 4 Press Esc to return to regular viewing mode 3 6 2 Capturing a picture 1 In OTOsuite click Capture in the Video Otoscopy section of the Navigation Panel The Video Otoscopy module is launched and AUR...

Page 14: ... or Left Ear button on AURICAL OTOcam 300 OTOsuite will switch to Capture mode Press the Right Ear or Left Ear button again to capture a picture 3 7 Edit mode In Edit mode you can add markers and comments to the individual pictures If you have assigned a picture to the wrong ear when you captured it you can assign it to the other ear The Edit toolbar Delete All Pictures Deletes all pictures captur...

Page 15: ...s Select the Eraser tool and click on the marker When you no longer want to use the Eraser tool click on the Pointer tool or a Marker in the toolbar Pointer tool The Pointer tool is selected as default When you no longer want to use the Eraser tool or a Marker tool click on the Pointer tool in the tool bar 3 7 1 Right click functions You can right click on a picture in one of the Picture Panels an...

Page 16: ...ck on the picture in the right or left Picture Panel The picture is shown in the cen ter of the screen 2 To add a marker click on one of the markers in the toolbar and click on the relevant area you wish to mark up on the central picture The markers will be listed ranging from A to Z The corresponding picture in the Picture Panel will be marked with a Comment icon 3 7 3 Removing markers You can re...

Page 17: ... If you have assigned a picture to the wrong ear when you captured it you can assign it to the other ear Right click on the relevant picture in the right or left Picture Panel and select Swap Ear 3 8 Deleting pictures You can delete individual pictures or all pictures Deleting individual pictures When you mouse over a picture in the right or left Picture Panel a Delete icon is shown for that pictu...

Page 18: ...en the video otoscopy window A Button for closing the window B Grabber for resizing the window 3 12 PC shortcut keys General shortcut keys are described in the OTOsuite User Manual Shortcut keys in Capture mode Shortcut key Function Spacebar Toggles the Freeze function L Captures the picture as Left Ear R Captures the picture as Right Ear Alt Enter Ctrl Enter Enters Full Screen View can also be do...

Page 19: ... picture as Right Ear Escape Esc Closes Full Screen View can also be done from right click menu or by double clicking on picure Alt Enter Ctrl Enter Closes Full Screen View Otometrics AURICAL OTOcam 300 19 3 Capturing and editing pictures ...

Page 20: ...ever use sharp or pointed objects for cleaning Warning Do not clean the otoscope in an ultrasonic bath and do not gas sterilize or autoclave the otoscope 1 Disconnect AURICAL OTOcam 300 from the computer 2 Use a soft slightly damp cloth with a small amount of mild detergent on it to clean the housing camera head plugs and cable Caution Do not allow any moisture inside the device 3 If the glass sur...

Page 21: ...tion The camera view area in the Video Otoscopy module is black Direct 3D is not rendered correctly by the graphics card Update the PC s graphics card driver Otometrics AURICAL OTOcam 300 21 4 Maintenance and Cleaning of AURICAL OTOcam 300 ...

Page 22: ...2003 CAN CSA 22 2 No 601 1 M90 Electronic equipment covered by the Directive 2002 96 EC on waste electrical and electronic equipment WEEE All electrical and electronic products batteries and accumulators must be taken to separate collection at the end of their working life This requirement applies in the European Union Do not dispose of these products as unsorted municipal waste You can return you...

Page 23: ...lier for advice AURICAL OTOcam 300 is intended for use by audiologists and other trained health care professionals in visually inspecting the ear canal and tympanic membrane Do not use the device for uses other than those described in the Intended Use section For example do not use the device for examination of nasal cavities eyes or larynx Do not store or operate AURICAL OTOcam 300 at temperature...

Page 24: ...ufacturer or personnel authorized by the manufacturer The electrical installation to which the equipment is connected complies with EN IEC requirements The equipment is used in accordance with the instructions for use The manufacturer reserves the right to disclaim all responsibility for the operating safety reliability and performance of equipment serviced or repaired by other parties 24 Otometri...

Page 25: ...10 micro lenses with fixed focus with large depth of field Sensor resolution 720 H x 720 V pixels Frame rate 24 frames second Output signals USB 2 0 Optical data Minimum working distance 10 mm 0 4 inches Preheater The preheater is active when the AURICAL OTOcam 300 is plugged into the PC and placed in its cradle Preheater activation Activated by magnet in cradle Preheater power Heats camera distal...

Page 26: ...e Expected Service life 5 years Storage environment Temperature 20 C to 60 C 4 F to 140 F Operating environment Temperature 10 C to 30 C 50 F to 86 F Air humidity 30 to 75 non condensing Air pressure 600 hPa to 1060 hPa Warm up time Warm up time 20 seconds Note In order for the pre heater to heat the camera tip to body temperature AURICAL OTOcam 300 should remain in the cradle connected to a PC wh...

Page 27: ... Type BF UL60601 1 CAN CSA C22 2 NO 601 1 90 EMC IEC 60601 1 2 2007 and EN 60601 1 2 2007 IEC 60601 1 2 2014 and EN 60601 1 2 2015 Safety Protection class II IEC 60601 1 IPX0 Application class BF Otometrics AURICAL OTOcam 300 27 App 1 Technical Specifications ...

Page 28: ... low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer sdeclaration electromagnetic immunity for all equipment and systems AURICAL OTOcam 300 is intended for use in the electromagnetic environment specified below The user of AUR...

Page 29: ...t must be more than 30 cm 11 8 inches Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people IEC 60601 1 2 2007 and EN 60601 1 2 2007 Guidance and manufacturer sdeclaration electromagnetic emissionsfor all equipment and systems AURICAL OTOcam 300 is intended for use in the electromagnetic environ...

Page 30: ...sure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 V rms 150 kHzto 80 MHz 3 V rms 150 kHzto 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of AURICAL OTOcam 300 including cables than the recommended separation distance calculated from the equat...

Page 31: ... The customer or the user of the AURICAL OTOcam 300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com munications equipment transmitters and the AURICAL OTOcam 300 as recommended below according to the maximum output power of the com munications equipment Rated maximum output power of transmitter W Separation distance according to fr...

Page 32: ...App 1 Technical Specifications 32 Otometrics AURICAL OTOcam 300 ...

Page 33: ...12 Capture Right 12 Delete 12 14 Eraser tool 14 Freeze 12 Full screen view 12 Pointer tool 14 Installing OTOcam 300 7 Intended use 5 Introduction 5 M Main window Video Otoscopy 11 Maintenance 20 Manufacturer 23 Markers 14 adding 16 removing 16 O OTOcam 300 assembly 7 cerumen removal 10 connecting 8 cradle 7 9 device type 25 introduction 5 maintenance and cleaning 20 safety 22 storing 7 switching o...

Page 34: ...rumen removal 10 disposal 20 how to use 10 Storing the device 7 Swap ear 17 Switching OTOcam 300 on off 8 T Technical specifications 25 video system 25 Toolbar capture 12 edit 14 U Unpacking and installing OTOcam 300 7 Unpacking the device 7 V Video Otoscopy module main window 11 PC shortcut keys 18 right click functions 15 Video system technical specifications 25 W Warning notes 22 Otometrics AUR...

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