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ISO 15223-1

Symbol 5.4.2

Do not reuse.
Indicates a medical device that is intended for one use, or for use on a single patient during a
single procedure.

21 CFR Part 801.

§801.109(b)(1)

Device is cleared for the US market as requiring a prescriptionUSA Code of Federal Regulations.
21 CFR Part 801. § 801.109(b)(1)

ISO 15223-1

Symbol 5.4.3 and

IEC 60601-1

Table D.1 #11

Consult instructions for use

Indicates the need for the user to consult the instructions for use.

IEC 60601-1

Table D.2 #10

Follow instructions for use

Complies with Class II requirements of the safety standard IEC 60601-1:2005+AMD1:2012 and
EN 60601-1:2006+A1:2013.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only
in accordance with ANSI/AAMI ES60601-1:2005 + A1:2012, C1:2009/(R)2012 and A2:2010
(R)2012, CAN/CSA-C22.2 NO. 60601-1:14 , IEC 60601-1:2005+A1:2012.

ISO 15223-1

Symbol 5.3.8

Humidity limitation

Indicates the range of humidity to which the medical device can be safely exposed.

ISO 15223-1

Symbol 5.3.7

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed.

ISO 15223-1

Symbol 5.3.9

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

Aurical Otocam 300

25

7 Aurical Otocam 300 video otoscope standards and safety

Содержание Aurical Otocam 300

Страница 1: ...Aurical Otocam 300 Aurical Otocam 300 and the Video Otoscopy Module Reference Manual Doc No 7 50 1340 EN 08 Part No 7 50 13400 EN...

Страница 2: ...metrics the Otometrics Icon Aurical Madsen HI PRO 2 Oto scan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 2020 05 11...

Страница 3: ...nt 11 4 4 Viewing pictures from old Otocam 300 software 12 4 5 The main window 12 4 6 Capture mode 13 4 6 1 Capture functions 13 4 6 2 Capturing a picture 14 4 6 3 Switching modes with Aurical Otocam...

Страница 4: ...anufacturer 28 7 2 1 Responsibility of the manufacturer 28 8 Technical Specifications 29 App 0 1 Accessories 29 8 1 Device 29 8 2 Notes on EMC Electromagnetic Compatibility 31 Index 37 4 Aurical Otoca...

Страница 5: ...out for the mouse or the keyboard of your computer The Otosuite Video Otoscopy module With the Otosuite Video Otoscopy module you can capture and edit pictures from AURICAL Aurical Otocam 300 You can...

Страница 6: ...complied with at all times Natus Medical Denmark ApS cannot be held responsible for unauthorized use of specula 2 3 About this manual This is your guide to using the Aurical Otocam 300 and the Otosuit...

Страница 7: ...e 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 risk of injury to the...

Страница 8: ...dea 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 Ins...

Страница 9: ...300 to one of the USB connections on the rear of Aurical Aud 2 Launch Otosuite and select the Otosuite Video Otoscopy module Aurical Otocam 300 is automatically connected to the Otosuite Video Otosco...

Страница 10: ...en it is not in use It controls the light source and the camera tip heating When Aurical Otocam 300 is placed in the cradle the light source is turned off and the camera tip heating is turned on No co...

Страница 11: ...ympanic membrane You can use specula specifically designed for cerumen removal with Aurical Otocam 300 Using a speculum to remove cerumen has several advantages over other techniques The lighted camer...

Страница 12: ...on Configure next to Video Otoscopy 3 Make sure that the path indicates the correct path to the old Otocam 300 pictures If it does not click the arrow to browse and select the correct path 4 5 The mai...

Страница 13: ...n visually inspect and capture pictures of the ear canal the tympanic membrane or other such applications 4 6 1 Capture functions The Capture toolbar Delete All Pictures Deletes all pictures captured...

Страница 14: ...press 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...

Страница 15: ...t Ear 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 4 7 Edit mode In Edit mode you can add markers and...

Страница 16: ...rkers 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 de...

Страница 17: ...1 Click 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...

Страница 18: ...The corresponding picture in the Picture Panel will be marked with a Comment icon 4 7 5 Assigning a picture to the other ear If you have assigned a picture to the wrong ear when you captured it you c...

Страница 19: ...copy window on top of the PMM window If you use Aurical FreeFit this can be useful in order to monitor the placement of the probe tube for example It can also be useful for training clients Click the...

Страница 20: ...s in Full Screen View mode Shortcut key Function Spacebar Toggles the Freeze function L Captures the picture as Left Ear R Captures the picture as Right Ear Escape Esc Closes Full Screen View can also...

Страница 21: ...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...

Страница 22: ...o medical equip ment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops In case of any defects make a detailed description of the defect s and con...

Страница 23: ...Problem Cause Solution 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 Aurical Otocam 300 23 6...

Страница 24: ...EC and 98 79 EC ISO 15223 1 Symbol 5 1 3 Date of manufacture Indicates the date when the medical device was manufactured ISO 15223 1 Symbol 5 1 7 Serial number Indicates the manufacturer s serial numb...

Страница 25: ...EC 60601 1 2005 AMD1 2012 and EN 60601 1 2006 A1 2013 MEDICAL General Medical Equipment as to electrical shock fire and mechanical hazards only in accordance with ANSI AAMI ES60601 1 2005 A1 2012 C1 2...

Страница 26: ...ment EEE contains materials components and substances that may be hazardous and present a risk to human health and the environment when WEEE is not handled correctly Therefore end users also have a ro...

Страница 27: ...ntact your supplier for advice Aurical Otocam 300 is intended for use by audiologists and other trained health care professionals in visually inspect ing the ear canal and tympanic membrane Do not use...

Страница 28: ...ifications 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 re...

Страница 29: ...ystem 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...

Страница 30: ...s Total weight 1300 g Service life Expected Service life 5 years Storage environment Temperature 20 C to 60 C 4 F to 140 F Relative humidity 90 non condensing Air pressure 500 hPa to 1060 hPa Operatin...

Страница 31: ...is suitable for use in all environments including domestic environments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes...

Страница 32: ...V m 710 MHz 745 MHz 780 MHz 28 V m 810 MHz 870 MHz 930 MHz 28 V m 1720 MHz 1845 MHz 1970 MHz 28 V m 2450 MHz 9 V m 5240 MHz 5500 MHz 5785 MHz Separation distance between any electronic parts of Aur i...

Страница 33: ...rge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humid ity should be at least...

Страница 34: ...io AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey shou...

Страница 35: ...here P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range ap...

Страница 36: ...8 Technical Specifications 36 Aurical Otocam 300...

Страница 37: ...Left 13 Capture Right 13 Delete 13 15 Eraser tool 15 Freeze 13 Full screen view 13 Pointer tool 15 Installing OTOcam 300 8 Intended use 6 Introduction 5 M Main window Video Otoscopy 12 Maintenance 21...

Страница 38: ...cerumen removal 11 disposal 21 how to use 11 Storing the device 8 Swap ear 18 Switching OTOcam 300 on off 9 T Technical specifications 29 video system 29 Toolbar capture 13 edit 15 U Unpacking and in...

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