AURICAL OTOcam 300 and Video Otoscopy Module User Guide Feb 2015

Copyrightnotice No part of this documentation orprogram may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any means, electronic, mechanical, photocopying, recording,or otherwise,without the prior written consent of GN Otometrics A/S. Copyright© 2015, GN Otometrics A/S Published in Denmark byGN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of publication. GN Otometrics A/Sreserves the right to make changes at any time without notice. Registered trademarks and Trademarks MADSEN Itera II,MADSEN OTOflex 100, OTOsuite,AURICAL FreeFit, AURICAL Visible Speech, MADSEN Astera², MADSEN Xeta, ICS Chartr 200 VNG/ENG, ICS Chartr EP, OTOcam 300, MADSEN AccuScreen, MADSEN AccuLink,ICS AirCal, AURICAL Aud, AURICAL HIT, ICS Impulse, OTObase and MADSEN Capella² are either registered trademarks ortrademarks of GN Otometrics A/S. Versionrelease date 2015-02-19 Technicalsupport Please contact your supplier.

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User Guide

Table of Contents 1

Introduction

4

2

Intended use

4

3

Typographical conventions

4

4

Unpacking OTOcam 300

5

5

Assembling OTOcam 300

5

6

Switching AURICAL OTOcam 300 on and off

6

7

The AURICAL OTOcam 300 cradle

7

8

Capturing and editing pictures with Video Otoscopy

7

9

Service, cleaning and maintenance

11

10 Other references

12

11 Accessories

12

12 Technical Specifications

12

13 Manufacturer

14

14 Warning notes

15

15 Notes on EMC (Electromagnetic Compatibility)

16

16 Definition of symbols

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Otometrics - AURICAL OTOcam 300

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User Guide

1

Introduction AURICAL OTOcam 300 is a video otoscope (VO) for visually inspecting and capturing pictures of the ear canal, the tympanic membrane or other such applications. AURICAL OTOcam 300 is used in connection with the OTOsuite Video Otoscopy module to capture and edit pictures.

2

Intended use AURICAL OTOcam 300 and the OTOsuite Video Otoscopy module Users: Audiologists, hearing instrument dispensers, ENT doctors and other trained personnel. Please note that local regulations may define users for video otoscopy differently. Local regulations must be complied with at all times. Use: 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.

Specula with cerumen management Please note that the use of specula with cerumen management may require special training in order to authorize personnel to carry out cerumen removal. These requirements are locally defined. Local regulations must be complied with at all times.GN Otometrics A/S cannot be held responsible for unauthorized use of specula.

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 precautionary 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 user or patient or risk of damage to data or the device.

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Note • Indicates that you should take special notice.

4

Unpacking OTOcam 300 1. Unpack the device carefully. When you unpack the device and accessories, it is a good idea to keep the packing material in which they were delivered. If you need to send the device in for service, the original packing material will protect against damage during transport, etc. 2. Visually inspect the equipment for possible damage. If damage has occurred, do not put the device into operation. Contact your local distributor for assistance. 3. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is incomplete, contact your local distributor.

4.1

Storing OTOcam 300 If you need to store AURICAL OTOcam 300 before you put it into operation, follow the guidelines below: • Store AURICAL OTOcam 300 and accessories in the boxes provided to protect the equipment from damage. •

5

Store AURICAL OTOcam 300 and accessories in a dry environment.

Assembling OTOcam 300 Only the cradle needs to be assembled. Use the supplied Allen key, screws and washer to assemble the cradle as shown.

Otometrics - AURICAL OTOcam 300

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User Guide

5.1

Installing OTOsuite Install OTOsuite on the PC before you connect to AURICAL OTOcam 300 from the PC. For instructions on installing OTOsuite, see the OTOsuite Installation Guide, which you can find on the OTOsuite installation medium (disk or memory stick).

5.2

Connecting OTOcam 300 to OTOsuite 1. Connect the USB cable of AURICAL OTOcam 300 to one of the computer’s USB ports. AURICAL OTOcam 300 is powered through the USB connection to the PC.

If you are using AURICAL OTOcam 300 in connection with AURICAL Aud, you can alternatively connect AURICAL OTOcam 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 Otoscopy module.

6

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 its cradle, the light beam is switched on.

–

If OTOcam 300 is placed in its cradle, the light beam is not switched on.

Warning • Do not stare into the light beam, or point the light beam in the direction of other people’s eyes. It can damage the eyes.

Switching off AURICAL OTOcam 300 To switch off OTOcam 300, disconnect the USB cable from the computer or switch off the computer.

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User Guide

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The AURICAL OTOcam 300 cradle The cradle is a multi-functional holder for your AURICAL OTOcam 300 when 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.

Avoid condensation 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 (which is powered on) and placed in its cradle. In order for the pre-heater to heat the camera tip to body temperature, AURICAL OTOcam 300 should remain in the cradle for approx. 5 minutes before the camera is used.

8

Capturing and editing pictures with Video Otoscopy 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

Otometrics - AURICAL OTOcam 300

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User Guide

After capturing pictures The left and right Picture Panels list the pictures you capture.

8.1

Capture mode In Capture mode you can inspect the ear and capture pictures with OTOcam 300.

The Capture toolbar

Delete All Pictures Delete all pictures captured in this session.

Icon

AURICAL OTOcam 300

Shortcut

Capture

L

Capture the picture as Left Ear.

R

Capture the picture as Right Ear.

Freeze You can freeze a picture before capturing it as a picture. 1. To freeze the image, click the Freeze icon in the toolbar or press the Spacebar. 2. If needed, click the Freeze icon or press the Spacebar to unfreeze the image.

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Full Screen mode Displays a full screen view of the selected picture. Press Esc to return to regular viewing mode.

8.2

Capturing a picture 1. In OTOsuite, click Capture in the Video Otoscopy section of the Navigation Panel. The Video Otoscopy module is launched and AURICAL OTOcam 300 is active.

Warning • Do not stare into the light beam, or point the light beam in the direction of other people’s eyes. It can damage the eyes.

2. Press a speculum onto the tip of AURICAL OTOcam 300.

Warning • Be careful when you insert the speculum in the ear of the patient - there is a risk of damaging the wall of the ear canal and/or the tympanic membrane.

The specula must be disposed of after single use. 3. Insert the speculum on AURICAL OTOcam 300 in the ear of the client. 4. When a satisfactory image is obtained, press the Right Ear or Left Ear button on AURICAL OTOcam 300.

8.3

Edit mode In Edit mode you can add markers and comments to the individual pictures.

Otometrics - AURICAL OTOcam 300

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User Guide

The Edit toolbar

Delete All Pictures Delete all pictures captured in this session.

Markers

•

Click on the desired marker in the Edit toolbar.

•

Position the cursor at the point where you wish to place the marker and click once.

Eraser tool •

Select the Eraser tool and click on the marker that you wish to remove.

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 toolbar.

Right-click functions You can right-click on a picture in one of the Picture Panels, and in Edit mode also on the central picture.

Delete Delete the selected picture.

Edit Select the picture for editing.

Copy to Clipboard Copy the selected picture including markers to the clipboard. You can paste the picture into other software programs.

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Swap Ear Assign a picture to the other ear.

Right-click functions on the central picture Remove All Markers Right-click anywhere in the central picture and select Remove All Markers.

Remove Marker Right-click on one marker in the central picture and select Remove Marker.

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Service, cleaning and maintenance Warning • Under no circumstances disassemble OTOcam 300. Contact your supplier. Parts inside OTOcam 300 must only be checked or serviced by authorized personnel.

9.1

Service and repair For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment 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 contact your supplier. Do not use a defective device.

Note • There are no user-serviceable parts inside the OTOcam 300 housing.

9.2

Cleaning Never 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.

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User Guide

Caution • Do not allow any moisture inside the device!

3. If the glass surface of the lens is very dirty, use a cotton pad with alcohol to clean it. 4. After cleaning, remove the cleaning agents thoroughly by wiping with a cloth dampened with pure, deionised water. 5. Finally, carefully dry all surfaces of AURICAL OTOcam 300 and the glass surface of the lens with a soft cloth.

Cleaning accessories Specula Specula are disposable and therefore should not be cleaned or re-used. There are no special requirements for the disposal of specula.

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Other references After you install OTOsuite, you can find OTOsuite manuals and related documentation on your PC. In the Start menu, open OTOsuite Manuals, which contains an overview with links to all manuals.

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Accessories Accessory Name

Part Number

Desktop cradle

8-35-30800

OTOsuite PC software

8-49-75800

Specula, normal (12 pcs)

8-62-42700

Specula, with cerumen management (12 pcs)

8-62-42710

Technical Specifications AURICAL OTOcam 300 is type 1076 from GN Otometrics A/S.

Video system Sensor

12

1/3" CMOS Digital Image Sensor

Otometrics - AURICAL OTOcam 300

User Guide

Lens System

10 micro lenses with fixed focus with large depth of field

Sensor resolution

720 (H) x 720 (V) pixels

Frame rate

24 frames/sec.

Output signals

USB 2.0

Optical data Minimum working distance

8 mm (0.3 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 tip to approx +5°C (9°F) above ambient temperature after 5 minutes of activation

Buttons Freeze frame

Right/left ear

Electrical data Supply voltage through USB port Input power

USB 2.0, Max. 500 mA.

Light source

2 LEDs, fibre-optic light guide

USB plug

USB, type A (LED power supply/Camera/Pre-heating)

Switch activated by magnet contact used to switch between pre-heating and light.

Mechanical data Cable length

2950mm (9.65 feet)

Length without cable

170mm ( 6.7 inches)

Weight including cable

225 g (8 ounces)

Largest diameter

45 mm (1.8 inches)

Distal diameter

max. 3.4 mm (0.134 inches)

Total weight

1300 g

Service life Expected Service life

5 years

Storage environment Temperature

Otometrics - AURICAL OTOcam 300

-20°C to +60°C (-4°F to +140°F)

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User Guide

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 which is powered on) for minimum 5 minutes before the camera is used. The time should be extended if AURICAL OTOcam 300 has been stored in a cold environment.

Standards Patient Safety

EMC

•

IEC 60601-1, Class II, applied part Type BF;

•

UL60601-1; CAN/CSA-C22.2 NO 601.1-90

IEC 60601-1-2

Safety

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Protection class

II IEC 60601-1, IPX0

Application class

BF

Manufacturer GN Otometrics A/S Hoerskaetten 9, 2630 Taastrup Denmark ( +45 45 75 55 55 7 +45 45 75 55 59 www.otometrics.com

13.1

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

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•

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

Otometrics - AURICAL OTOcam 300

User Guide

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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Warning notes This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times. When the Video Otoscopy module is used in conjunction with a device (including devices other than those produced by Otometrics), make sure that all information and warnings in the documentation of the device are followed.

Warning • Do not stare into the light beam, or point the light beam in the direction of other people’s eyes. It can damage the eyes.

Warning • For continued protection against fire hazard, replace fuses with the same type and rating only.

•

Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.

•

No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended Use section of this manual.

•

For safety reasons, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system.

•

This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional.

•

Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere with the performance of the device. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We recommend that the use of such devices in the vicinity of AURICAL OTOcam 300 be restricted.

•

RF emissions from AURICAL OTOcam 300 are very low and are not likely to cause any interference in nearby electronic equipment. However, local devices placed in close vicinity of AURICAL OTOcam 300 may experience a negative effect or loss of functionality..

•

It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example, anti-static carpeting is recommended.

•

To prevent cross-infection or re-infection, the specula must be disposed of after single use.

•

Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your supplier 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.

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User Guide

•

Do not store or operate AURICAL OTOcam 300 at temperatures and humidity exceeding those stated in Technical Specifications. Noncompliance can have negative effects on performance and/or cause degradation of device components.

•

Be careful when you insert the speculum in the ear of the patient - there is a risk of damaging the wall of the ear canal and/or the tympanic membrane. Do not apply excessive force to the outer ear with the speculum. When you connect other electrical equipment to AURICAL OTOcam 300, remember that equipment that does not comply with the same safety standards as AURICAL OTOcam 300 can lead to a general reduction in the system's safety level. The equipment must comply with IEC 60950. When selecting accessories connected to the AURICAL OTOcam 300, the following points must be considered: • Use of connected equipment in a patient environment

• Proof that connected equipment has been tested in accordance with IEC60601-1 and/or IEC60601-1-1 Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the instrument and it may result in a risk of electrical shock to the user or patient.

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Notes on EMC (Electromagnetic Compatibility) AURICAL OTOcam 300 is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely. Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of AURICAL OTOcam 300. Guidanceand manufacturer's declaration - electromagnetic emissions for all equipment and systems AURICAL OTOcam 300 is intended for use in the electromagnetic environment specified below. The user of AURICAL OTOcam 300should ensure that it is used in such an environment. Emissionstest

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

AURICAL OTOcam 300 uses RF energy only for its internal function. Therefore, its RF emis-

CISPR 11

sions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

Class B

CISPR 11

AURICAL OTOcam 300 is suitablefor use in all environments, including domestic environmentsand those directly connected to the public low-voltage power supply network that supplies buildingsused for domestic purposes.

Harmonic emissions IEC 61000- 3-2

Not applicable

Voltagefluctuations/flicker emissionsIEC Not applicable 61000-3-3

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Guidanceand manufacturer's declaration - electromagnetic immunity for all equipment and systems AURICAL OTOcam 300 is intended for use in the electromagnetic environment specified below. The user of AURICAL OTOcam 300should ensure that it is used in such an environment. Immunitytest

IEC 60601

Compliancelevel

Electromagnetic environment - guidance

+/- 6 kV contact

+/- 6 kV contact

Floors should bewood, concrete or ceramic tile. If floors are covered with syn-

+/- 8 kV air

+/- 8 kV air

thetic material, the relative humidity should be at least 30%.

3A/m

3A/m

Power frequency magnetic fields should be at levels characteristic of a typical

test level

Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic field

location in a typical commercial or hospital environment.

IEC 61000-4-8

Note • UT is the AC mains voltage prior to application of the test level.

Otometrics - AURICAL OTOcam 300

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User Guide

Guidanceand manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting AURICAL OTOcam 300 is intended for use in the electromagnetic environment specified below. The user of AURICAL OTOcam 300should ensure that it is used in such an environment. Immunity test

IEC 60601

Compliance level

Electromagnetic environment - guidance

test level Radiated RF

150 kHzto 80 MHz

Portableand mobile RF communications equip-

IEC 61000-4-3

outsideISM bands

ment should be used no closer to any part of

3V/m 80MHz to 2.5 GHz

AURICAL OTOcam 300, including cables,than the 3V/m

recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2

for 80MHz to 800 MHz

d = 2.3

for 80MHz to 2.5 GHz,

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengthsfrom fixed RF transmitters, as determined by an electromagnetic site survey, a should beless than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with this symbol:

Note 1:At 80 MHzand 800 MHz the separation distancefor the higher frequency range applies. Note 2:These guidelinesmay not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengthsfrom fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,amateur radio, AM and FMradio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should beconsidered. If the measured field strength in the location in which AURICAL OTOcam 300 isused exceeds the applicable RF compliance level above, the AURICAL OTOcam 300should be observed to verify normal operation. If abnormal performance isobserved, additional measuresmight benecessary, such as reorienting or relocating AURICAL OTOcam 300. b. Over the frequency range 150 kHzto 80MHz, field strengths should beless than 3 V/m.

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Recommended separation distances between portable and mobile RF communications equipment and AURICAL OTOcam 300 The AURICAL OTOcam 300is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AURICAL OTOcam 300can help prevent electromagnetic interference by maintaining a minimum distance between portableand mobile RF communications equipment (transmitters) and the AURICAL OTOcam 300as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

Separation distance according to frequency of transmitter m

W 150 kHzto 80MHz

80MHz to 800 MHz

d = 1.2

800 MHz to 2.5 GHz

d = 1.2

d = 2.3

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1:At 80 MHzand 800 MHz the separation distancefor the higher frequency range applies. Note 2:These guidelinesmay not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Definition of symbols Complies with Type BF requirements of IEC60601-1.

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Consult user manual for warnings and cautions.

Follow instructions for use.

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User Guide

Complies with Class II requirements of the safety standard IEC 60601-1.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, first edition, 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 your device and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal. Used in error message dialogs if software program fails. See the detailed information in the dialog box.

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Otometrics - AURICAL OTOcam 300