Aurical Otocam 300 and the Video Otoscopy Module User Guide Rev 07 May 2020

Copyright notice © 2014, 2020 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics Icon, Aurical, Madsen, HI-PRO 2, Otoscan, 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 (216990) Technical support Please contact your supplier.

2

Aurical Otocam 300

User Guide

Table of Contents 1

Introduction

4

2

Intended use

4

3

Typographical conventions

4

4

Unpacking

5

5

Assembling

5

6

Switching Aurical Otocam 300 on and off

7

7

The Aurical Otocam 300 cradle

7

8

Capturing and editing pictures with Video Otoscopy

7

9

Service, cleaning and maintenance

11

10 Troubleshooting

13

11 Other references

13

12 Technical Specifications

13

13 Definition of symbols

19

14 Warning notes

22

15 Manufacturer

23

Aurical Otocam 300

3

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

2.1

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.

Intended patient population The intended patient population is all patient groups from pediatric through adulthood.

2.2

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.Natus Medical Denmark ApS 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:

4

Aurical Otocam 300

User Guide

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.

Note • Indicates that you should take special notice.

4

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

Aurical Otocam 300

5

User Guide

5.1

Installing Otosuite Install Otosuite on the PC before you connect to Aurical Otocam 300 from the PC. For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium.

5.2

Connecting Aurical 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.

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Aurical Otocam 300

User Guide

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.

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.

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 completely switch off Otocam 300, disconnect the USB cable from the computer.

7

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.

Aurical Otocam 300

7

User Guide

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

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.

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Aurical Otocam 300

User Guide

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.

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.

Aurical Otocam 300

9

User Guide

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.

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.

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Aurical Otocam 300

User Guide

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.

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.

9

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.

Aurical Otocam 300

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User Guide

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.

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.

9.3

Maintenance Aurical Otocam 300 requires no preventive maintenance except for cleaning and regular inspection of cable and plastic housing of the device.

Warning • 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.

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Aurical Otocam 300

User Guide

10

11

Troubleshooting 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.

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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Technical Specifications Type identification Aurical Otocam 300 is type 1076 from Natus Medical Denmark ApS.

Video system Sensor

0.3 inch CMOS Digital Image Sensor

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

Buttons Freeze frame

Aurical Otocam 300

Right/left ear

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User Guide

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

2700 mm (8.86 feet)

Length without cable

170mm ( 6.7 inches)

Weight including cable

250 g (8.8 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

-20°C to +60°C (-4°F to +140°F)

Relative humidity

<90%, non-condensing

Air pressure

500 hPa to 1060 hPa

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

Essential performance Aurical Otocam 300 has no essential performance.

Standards Patient Safety

IEC 60601-1:2005+AMD1:2012 and EN 60601-1:2006+A1:2013 CAN/CSA-C22.2 NO. 60601-1:14 Class II; applied part Type BF; IPX0 Endoscopic equipment: IEC 60601-2-18:2009 and EN 60601-2-18:1996 + A1:2000

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Aurical Otocam 300

User Guide

EMC

12.1

12.2

IEC 60601-1-2:2007 and EN 60601-1-2:2007 IEC 60601-1-2:2014 and EN 60601-1-2:2015

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

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 highfrequency communication devices, such as mobile phones, may interfere with the functioning of Aurical Otocam 300.

IEC 60601-1-2:2014 and EN 60601-1-2:2015 Guidance and 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 300 should ensure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

Aurical Otocam 300 uses RF energy only for its internal function. Therefore, its RF emissions are

CISPR11 RF emissions

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

CISPR11

Aurical Otocam 300 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.

Harmonic emissions IEC

Not applicable

61000-3-2 Voltage fluctuations/flicker

Not applicable

emissions IEC 61000-3-3

Guidance and 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 300 should ensure that it is used in such an environment.

Aurical Otocam 300

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User Guide

Immunity test

IEC 60601

Compliance level

Electromagnetic environment - guidance

test level Electrostatic discharge (ESD)

+/- 8 kV contact

+/- 8 kV contact

Floors should be wood, concrete or ceramic tile. If floors

IEC 61000-4-2

+/- 2 kV, +/- 4 kV,

+/- 2 kV, +/- 4 kV,

are covered with synthetic material, the relative humid-

+/- 8 kV, +/- 15 kV air

+/- 8 kV, +/- 15 kV air

ity should be at least 30 %.

+/- 1 kV for input/output lines

+/- 1 kV for input/output lines

30 A/m

No relevant ports that could be

Power frequency magnetic fields should be at levels char-

affected

acteristic of a typical location in a typical commercial or

Electrical fast transient/burst IEC 61000-4-4 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

hospital environment.

Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment Aurical Otocam 300 is intended for use in the electromagnetic environment specified below. The user of Aurical Otocam 300 should ensure that it is used in such an environment. Immunity test

IEC 60601

Compliance level

Electromagnetic environment - guidance

test level Conducted RF

3 V rms

3 V rms

IEC 61000-4-6

150 kHz to 80 MHz

150 kHz to 80 MHz

6 V rms

6 V rms

IISM Bands and Amateur

IISM Bands and Amateur

Radiated RF

10 V/m

10 V/m

IEC 61000-4-3

80 MHz to 2.7 GHz

80 MHz to 2.7 GHz

Proximity fields from RF wire- 27 V/m

27 V/m

Separation distance between any electronic parts of Aur-

less communications

385 MHz

385 MHz

ical Otocam 300 and any RF wireless communication

28 V/m

28 V/m

450 MHz,

450 MHz,

9 V/m

9 V/m

710 MHz, 745 MHz, 780 MHz

710 MHz, 745 MHz, 780 MHz

28 V/m

28 V/m

810 MHz, 870 MHz, 930 MHz,

810 MHz, 870 MHz, 930 MHz,

28 V/m

28 V/m

1720 MHz, 1845 MHz, 1970 MHz

1720 MHz, 1845 MHz, 1970 MHz

28 V/m

28 V/m

2450 MHz,

2450 MHz,

9 V/m

9 V/m

5240 MHz, 5500 MHz, 5785 MHz

5240 MHz, 5500 MHz, 5785 MHz

IEC 61000-4-3

16

equipment 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.

Aurical Otocam 300

User Guide

IEC 60601-1-2:2007 and EN 60601-1-2:2007 Guidance and 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 300 should ensure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

Aurical Otocam 300 uses RF energy only for its internal function. Therefore, its RF emissions are

CISPR11 RF emissions

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

CISPR11

Aurical Otocam 300 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.

Harmonic emissions IEC

Not applicable

61000-3-2 Voltage fluctuations/flicker

Not applicable

emissions IEC 61000-3-3

Guidance and 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 300 should ensure that it is used in such an environment. Immunity test

IEC 60601

Compliance level

Electromagnetic environment - guidance

test level Electrostatic discharge (ESD)

+/- 6 kV contact

+/- 6 kV contact

Floors should be wood, concrete or ceramic tile. If floors

IEC 61000-4-2

+/- 8 kV air

+/- 8 kV air

are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

+/- 1 kV for input/output lines

+/- 1 kV for input/output lines

3 A/m

3 A/m

IEC 61000-4-4 Power frequency

Power frequency magnetic fields should be at levels char-

(50/60 Hz) magnetic field

acteristic of a typical location in a typical commercial or

IEC 61000-4-8

hospital environment.

Guidance and 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 300 should ensure that it is used in such an environment. Immunity test

IEC 60601

Compliance level

Electromagnetic environment - guidance

test level

Aurical Otocam 300

17

User Guide

Conducted RF

3 V rms

3 V rms

Portable and mobile RF communications equipment

IEC 61000-4-6

150 kHz to 80 MHz

150 kHz to 80 MHz

should be used no closer to any part of Aurical Otocam 300, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1.2

for 80 MHz to 800 MHz

d = 2.3

for 80 MHz to 2.5 GHz,

where P is the maximum output power rating of the Radiated RF

3 V/m

3 V/m

transmitter in watts (W) according to the transmitter

IEC 61000-4-3

80 MHz to 2.5 GHz

80 MHz to 2.5 GHz

manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less 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 MHz and 800 MHz the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, 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 should be considered. If the measured field strength in the location in which Aurical Otocam 300 is used exceeds the applicable RF compliance level above, the Aurical Otocam 300 should be observed to verify normal operation. If abnormal performance is observed, additional measures might be necessary, such as reorienting or relocating Aurical Otocam 300. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and Aurical Otocam 300 The Aurical Otocam 300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. 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 communications equipment (transmitters) and the Aurical Otocam 300 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of

Separation distance according to frequency of transmitter

transmitter

m

W

18

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2

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

Aurical Otocam 300

User Guide

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 MHz and 800 MHz the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

13

Definition of symbols Manufacturer

ISO 15223-1

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

Symbol 5.1.1

Date of manufacture. Indicates the date when the medical device was manufactured. ISO 15223-1 Symbol 5.1.3

Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified. ISO 15223-1 Symbol 5.1.7

Catalog/product number Indicates the manufacturer’s catalogue number so that the medical device can be identified. ISO 15223-1 Symbol 5.1.6

Type BF applied part Complies with Type BF requirements of IEC 60601-1. IEC 60601-1 Table D.1 #20

CE marking of conformity 93/42/EEC

Aurical Otocam 300

Certification mark that indicates conformity with applicable regulations and directives for the European Economic Area.

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User Guide

Medical device

Use-by date Indicates the date after which the medical device is not to be used. ISO 15223-1 Symbol 5.1.5

ISO 15223-1

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

Symbol 5.4.2

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

Consult instructions for use Indicates the need for the user to consult the instructions for use. ISO 15223-1 Symbol 5.4.3 and IEC 60601-1 Table D.1 #11

Follow instructions for use IEC 60601-1 Table D.2 #10

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

ISO 15223-1 Symbol 5.3.8

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Aurical Otocam 300