AURICAL FreeFit User Guide, EN version

AURICAL FreeFit

OTOsuite PMM Module

OTOsuite Counseling and

Simulations Module

User Guide

Doc. No. 7-50-1220-EN/06

Part No. 7-50-12200-EN

Copyright notice

© 2012, 2017 GN Otometrics A/S. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICS and HORTMANN are registered trademarks of GN Otometrics A/S in the U.S.A. and/or other countries.

Version release date

2017-03-12 (153432)

Technical support

Please contact your supplier.

2

Otometrics - AURICAL FreeFit

Table of Contents

1

Device Description

2

Intended use

3

Unpacking AURICAL FreeFit

4

Installation

5

Powering the device

6

Switching AURICAL FreeFit on or off

7

Connecting AURICAL FreeFit to PMM

8

AURICAL FreeFit probes

9

Toolbar icons in PMM and Counseling and Simulations

10 Simulating hearing loss

11 Simulating hearing instruments

12 Speech Mapping

13 Performing probe microphone measurements

14 Demonstrating hearing instrument features

15 Service, cleaning and maintenance

16 Other references

17 Technical specifications

18 Manufacturer

19 Warning notes

20 Notes on EMC (Electromagnetic Compatibility)

21 Definition of symbols


17

21

22

23

11

12

14

17

27

28

31

23

26

6

7

7

8

4

4

5

5

User Guide

3

User Guide

1 Device Description

AURICAL FreeFit is used for measuring the sound pressure level close to the client's eardrum as well as outside the ear by the pinna for both ears simultaneously.

AURICAL FreeFit should only be charged using the type 1053 charger unit or the type 1081 AURICAL speaker unit from GN

Otometrics A/S.

4

Type 1053 charger unit AURICAL speaker unit with charger

Note

•

This manual describes the assembly and use of the type 1053 charger unit. If you use the AURICAL speaker unit to charge your FreeFit, see the manual for AURICAL Aud.

Note

•

For information about the Counseling and Simulations software, see the manual for AURICAL Visible Speech and the Counseling and Simulations Module.

You use the OTOsuite PMM module and the Counseling and Simulations module to operate AURICAL FreeFit. AURICAL

FreeFit cannot be used without OTOsuite software.

2

2.1

Intended use

Users: audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals.

Use: to visualize the amplified signal recorded in the ear with reference information such as target curves to provide an objective basis for adjusting the hearing instrument settings.

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.


User Guide

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.

3 Unpacking AURICAL FreeFit

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 Installation

Installation for desk top use Wall mount installation

Mounting the NOAHLink charger on the

AURICAL FreeFit charger base plate


5

User Guide

5 Powering the device

Caution

• Use only the following battery types:

Rechargeable, Ni-MH, AA (R6) 1.2V, 1 pc.(Use only rechargeable batteries supplied by GN Otometrics A/S). Can also be used with Alkaline AA (R6) 1.2V, 1 pc.

A.

Press to open

6

5.1

Recharging the battery using the charger stand

Warning

• If you are using an alkaline battery, do not attempt to charge your AURICAL FreeFit. Your alkaline battery may be damaged and leak, and this may in turn cause damage to AURICAL FreeFit. Place

FreeFit in the charger unit only if AURICAL FreeFit contains a rechargeable battery.

Batteries should be removed if equipment is not likely to be used for some time.

Caution

• To power the charger, you must use an IEC/UL 60601-01 certified power adaptor supplying 9 V DC, min.

300 mA and with a maximum available output of 15 W. The adapter supplied with the unit meets these specifications.


User Guide

6 Switching AURICAL FreeFit on or off

Warning

• Unless you are charging AURICAL FreeFit with the AURICAL Aud speaker unit, which has a medically isolated power supply unit, do not attempt to use AURICAL FreeFit with clients while it is placed in the charger unit.

To switch on FreeFit

Press and hold the power button on top of the device until the status indicator light turns on. The status indicator will light for about 3 seconds, and then go into periodic flashing.

To switch off FreeFit

Press and hold the power button on top of the device until the status indicator light turns off.

7

A.

Power button

Connecting AURICAL FreeFit to PMM

When you use PMM for the first time, run the configuration wizard to set up the connection between AURICAL FreeFit and PMM.

After you have configured PMM for the first time, if FreeFit is turned on when you open the Control Panel in PMM, then

FreeFit will connect to PMM automatically. Otherwise, you can connect FreeFit as follows:

1. Switch on FreeFit.

2. In PMM, on the toolbar, click

Control Panel

.

3. In the control panel, click

Connect

.


7

User Guide

8 AURICAL FreeFit probes

Probe with original accessories

A.

Probe tube port

B.

Marker ring

C.

Ear cord

D.

Probe tube support

E.

Probe tube

F.

Transducer tube port (RECD probe only)

G.

Probe housing

Probe with probe enhancement accessories

8

A.

Probe tube port

B.

Marker ring

C.

Probe tube support

D.

Ear hook

E.

F.

G.

Probe tube with millimeter markings

Transducer tube port (RECD probe only)

Probe housing

The ear cord or ear hook is used to hang the probe below the client's ear. The probe tube is inserted into the ear canal for probe microphone measurements. The probe tube has a black marker ring for marking how far into the ear canal the tube should be inserted. The probe tube support is used to stabilize the position of the probe tube. Before you make RECD measurements, you fit a transducer tube on the transducer tube port.


User Guide

8.1

8.2

Fitting probe tubes on the probes

A bag of silicone probe tubes is supplied together with AURICAL FreeFit.

To fit a probe tube on the probe

Fit a probe tube to the probe tube port (thin metal tube) at the top of the probe housing. Gently push and twist the probe tube down as far as possible over the port.

Calibrating the probe tubes

Note

•

To prevent cross-infection, use new probe tubes for each client.

1. Fit a new probe tube on the probe.

2. Insert the free end of the probe tube in the test location on the probe.

8.3

A.

Probe tube

B.

Test location for probe tube calibration

3. Make sure that AURICAL FreeFit is connected to PMM.

4. Press the power button briefly on AURICAL FreeFit.

The

Probe Tube Calibration

dialog box appears and the calibration starts automatically.

Alternatively, launch the wizard with the toolbar icon. In RECD, pressing the power button starts an ear measurement.

5. If the tube calibration fails, check whether the tubes are blocked (pinched or clogged) and try to eliminate sources of ambient noise.

Fitting the probes on the client and inserting the probe tubes

It is important that the probe tube for every measurement is inserted correctly and consistently in the ear of the client.

For adults and children 16 years and older, it is recommended to use the ProbeTube Assistant to assist you with positioning the probe tubes. Alternatively, you can place the tubes based on recommended distances.

1. Place the black marker ring at the recommended distance from the tip of the probe tube.


9

User Guide

2. If the reference point of the black marker ring is the intertragus notch, you can add 8 mm for the concha depth.

Note

• To avoid touching the ear drum, you must take into account that the probe tube should not be inserted closer to the ear drum than 4 mm.

Note

• The length of ear canal may vary from country to country and even depending on the physical size of the patient, so make sure that you take this into account when you use the recommended distances.

Note

• In the case of children, otoscopy is especially recommended to prevent contact with the eardrum.

Recommended distances

The recommended distances are based on the complete average lengths of ear canals, where the reference point is at the opening of the ear canal.

Men

Women

Children from 6 months

25-29 mm

22-26 mm

18-22 mm

Distances are based on:

• ISO 12124:2001

• Wayne Staab, The Human Ear Canal -V, July 7, 2014.

• Voss SE(1), Herrmann BS. How does the sound pressure generated by circumaural, supra-aural, and insert earphones differ for adult and infant ears? Ear Hear. 2005 Dec; 26(6):636-50.

3. Place the ear cords or ear hooks with the probes over the ears of the client. Adjust the length of the ear cords or ear hooks, if required.

10

With original probe accessories

With probe enhancement accessories

4.

Be careful!

Carefully insert the probe tube into the ear canal until the black marker ring reaches the intertragal notch.


User Guide

9 Toolbar icons in PMM and Counseling and

Simulations

The icons available in the toolbar depend on the test function that you have selected.


Select device.

Toggle between Response, Gain, REIG and Predicted Aided Audiogram (PAA) views.

(PMM)

Select view:

HL

: Hearing Level or

SPL

: Sound Pressure Level

Select audiogram view: Left, both or right

Open

Fitting Details

dialog. (PMM)

Note

• You must select the

Use OpenREM calibration

option if you are fitting an open ear instrument.

Open

Listen at the Eardrum

/

Listen in the Coupler

window to record the signal at the eardrum or in the coupler, or monitor the signal through your headphones.

(PMM)

Show/hide

Legend

and

Overlays

box.

Switch to

Feature-2-Benefit

view.

(PMM - FreeStyle only)

Launch probe tube calibration wizard.

Toggle between standard calibration and OpenREM calibration.

(PMM)

Select previously measured RECD values.

(RECD only)


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User Guide


Toggle between coupler fitting mode and Real Ear fitting mode.

(PMM)

Show/Hide

OnTarget

view, which displays the difference between the target curve and the measured curve.

(Aided Response only)

Open the

Live Video Otoscopy

window on top of the current tab to view otoscopy video from OTOcam.

(PMM)

Open the ProbeTube Assistant for guided assistance in placing the probe tube in the patient's ear canal.

Switch to

On Top

mode.

Click to reload the original audiogram.

(Simulators only)

Display the Predicted Aided Audiogram.

(Hearing Instrument Simulator only)

Select text file to read aloud.

(Counseling and Simulations only)

10 Simulating hearing loss

The buttons that are available in the Control Panel depend on:

• The

Speaker Channel

setting in the Configuration Wizard (

Left

or

Right

for one speaker or

Left + Right

for two speakers)

• The

Sound Output

setting in

Options

(

Headphone

or

Speaker

).

Hearing Loss Simulator - with headphones or two speakers

Play the selected signal. While the signal plays, you can switch between presenting the signal in the following modes:

• without hearing loss simulation, or

• with hearing loss simulation for both ears.

12


User Guide

Note

• When you use headphones or two speakers, you can use the volume slider to lower the volume of one speaker or headphone, in order to demonstrate one ear at a time.

Hearing Loss Simulator - with one speaker


• without hearing loss simulation, or or

10.1

Without simulation

• with hearing loss simulation for selected ears. (If you select

Both

, the hearing losses from both ears are simulated together in the single speaker.)

A.

Status indicator

B.

Normal HTLs

C.

Client's HTLs (inactive)

D.

Speech Banana and Speech Letters (default overlays)

E.

Unusable Area (default overlay)


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User Guide

10.2

With simulation

A.

Area of opportunity

B.

Predicted UCL (no symbols)

C.

Measured UCL (symbols)

D.


11 Simulating hearing instruments

The buttons that are available in the Control Panel depend on:

• The

Speaker Channel

setting in the Configuration Wizard (

Left

or

Right

for one speaker or

Left + Right

for two speakers)

• The

Sound Output

setting in

Options

(

Headphone

or

Speaker

).

Hearing Instrument Simulator - with one speaker


• without hearing instrument simulation, or

• with hearing instrument simulation for selected ear.

or

Hearing Instrument Simulator - with two speakers


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User Guide


• with hearing instrument simulation for both ears.

Hearing Instrument Simulator - with headphones



• with hearing instrument simulation for selected ear or both ears.

or

11.1

With versus without hearing instrument simulation - HL

A.

Status indicator

B.

Client’s HTLs (inactive)

C.

Customized Speech Banana and Speech Letters (default overlays)

D.


E.


F.

Counseling and Simulations spectrum (default overlay)

G.


Use the customized speech banana to explain the concept of reduced dynamic range and the purpose of compression in hearing instruments.


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User Guide

11.2

With versus without Hearing Instrument Simulation - SPL

A.


B.


11.3

The Predicted Aided Audiogram view

C.

Client’s HTLs

16

A.

Client's HTL

B.

Predicted Aided Audiogram


User Guide

In the Predicted Aided Audiogram view, the traditional speech banana is displayed instead of the customized speech banana. When you simulate use of a hearing instrument, the audiogram is displayed with a lowered threshold, to demonstrate that the client would have access to a greater part of the sound signal, and thereby improved access to the speech banana.

The displayed values are the client’s thresholds minus the target insertion gain.

12 Speech Mapping

The

Speech Mapping

screen in

Counseling and Simulations

allows you to perform probe microphone measurements to demonstrate that speech sounds that are amplified by the hearing instrument are audible, and are presented within the client's remaining hearing range.

If you are using AURICAL FreeFit, you can use the

FreeStyle

screen in PMM for this purpose.

13 Performing probe microphone measurements

When you start a new session in PMM, you must ensure the fitting parameters are set correctly in the

Fitting Details

dialog box.

To set the fitting parameters

1. Press F10 to open the

Fitting Details

dialog box.

2. Select the appropriate target rule.

3. Fill in the remaining fields in the dialog box.

Making Probe Microphone Measurements

The following sections describe the main procedures involved in PMM:

Measuring RECD ► 17

Measuring Unaided Response ► 19

Measuring Occluded Response ► 20

Measuring Aided Response ► 20

13.1

Measuring RECD

If you want to use measured RECD values for coupler based fitting, you can measure RECD in PMM as follows:

Measure coupler response:

Skip this procedure if you have a stored coupler measurement.

1. Open the

RECD

tab in PMM.

2. Indicate the type of coupler adapter you are using, and whether you are using an ear mold or foam insert tip.

3. Click

Coupler Response

... in the RECD Control Panel.

4. Attach the right RECD ear probe to the coupler in AURICAL HIT.


17

User Guide

A.

RECD coupling

B.

BTE adapter tube

C.

BTE (HA2) adapter

D.

Transducer tubing

E.

Transducer tube port

5. Click the

Measure Right

button.

6. Connect the left probe to the coupler in AURICAL HIT.

7. Click the

Measure Left

button.

8. Click

OK

.

9. Remove the probe from AURICAL HIT and remove the RECD coupling from the tubing of the BTE coupler.

Then measure real ear response:

1. Attach the probes to the FreeFit.

2. Perform probe tube calibration.

3. Connect the RECD coupling to the ear mold tubing (or foam insert tip).

A.

Transducer tubing

B.

RECD coupling

C.

Ear mold or foam insert tip

D.

Transducer tube port

E.

Probe tube

18

4. Place the probe tubes in the client’s ears together with the ear molds or foam insert tips (see

the client and inserting the probe tubes ► 9

).

Fitting the probes on


User Guide

5. Select ear to measure.

6. In the control panel, click

Ear Response

(or briefly press the power button on the FreeFit).

The measured ear response and the RECD are displayed in their respective graphs.

13.2

Measuring Unaided Response

In the

Unaided

screen, measure without hearing instruments to determine the natural amplification of the ear canal.

1. Insert probe tube.

2. Select ear to measure.

3. Select graph.

4. Click the

Unaided

button on the Control Panel.

Note

•

In an unaided measurement, we usually expect a peak on the measurement curve around the 3kHz frequency of about 10-20 dB SPL.


19

User Guide

A.

UCL

B.

Audiogram

C.

Peak around 3 kHz

D.

Measurement curve

13.3

Measuring Occluded Response

In the

Occluded Response

screen, measure with muted hearing instruments in ears to measure the occlusion or openness of the fitting.

1. Place the hearing instrument on the ear of the patient, with the probe tube inserted in the ear canal. Ensure the hearing instrument is muted or turned off.

2. Click the

Occluded

button on the Control Panel.

When you compare the REUR to the REOR, you can see the impact of the occlusion of the ear canal.

13.4

Measuring Aided Response

In the

Aided

screen, measure the gain that the hearing instruments are providing in relation to a specified prescriptive fitting target.

1. Place the hearing instrument on the ear of the patient, with the probe tube inserted in the ear canal.

Note

•

For Coupler based fitting, select the Coupler based fitting icon on the toolbar and attach the hearing instrument to the coupler in AURICAL HIT (see the manual for AURICAL HIT).

2. Switch the hearing aid on without moving it.

All the hearing instrument features should be left on with the general use program selected.

3. Configure the control panel to play up to 5 signals. For example: 3 input levels for a speech or speech-like stimulus:

Soft (50/55 dB SPL), Average (65 dB SPL) and Loud (80 dB SPL) plus an MPO stimulus.

4. Present the various input levels and MPO signal separately or in one sequence.

20


User Guide

5. Compare the measured aided response curve to the prescriptive target values (dashed curve) and the measured MPO curve to the UCL. Consider adjusting the MPO (Maximum Power Output) if indicated by any report of loudness discomfort.

6. Adjust the hearing instrument with the fitting software to achieve the desired gain, and repeat the measurements to evaluate the effects of the changes.

A.

Sequence button

B.

Measurement buttons for different stimuli

C.

Curve legend for button 1.

D.

Target curve for MPO.

E.

Measurement curve for MPO.

F.

Measurement curve and target curve for button 1.

You can also select

OnTarget

view, which shows a live display of the difference between the target curve and the measured curve. This makes it easier to adjust the HI programming.

14 Demonstrating hearing instrument features

Use the

Noise Reduction

screen to evaluate and demonstrate the hearing instrument’s noise reduction feature. Each

Noise Reduction test is an automatic sequence that contains two curves (with a delay between the two curves):

• Curve 1 – a snapshot taken immediately before Noise Reduction takes effect.

• Curve 2 – a snapshot taken automatically after the selected Adaptation Interval, when the Noise Reduction has taken effect.

To demonstrate the Noise Reduction feature:

1. Program the hearing instrument for the desired Noise Reduction setting.


21

User Guide

2. Configure the measurement buttons to demonstrate the conditions you prefer. For each button, select the time difference between the two measurements (Curve 1 and Curve 2).

3. Click a measurement button in the control panel.

The snapshot curves are displayed in the graph and the overall Noise Reduction is displayed in the curve legend.

The

Feature-2-Benefit

view gives you the opportunity to see and show the gain difference in an easy to understand graph.

The

FreeStyle

test screen is similar to the other PMM test screens but with numerous possibilities to customize protocols.

15 Service, cleaning and maintenance

Warning

• Under no circumstances disassemble AURICAL FreeFit or the AURICAL FreeFit charger. Contact your supplier. Parts inside AURICAL FreeFit and the AURICAL FreeFit charger must only be checked or serviced by authorized personnel.

15.1

Service

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.

15.2

Cleaning

Use a soft, slightly damp cloth with a small amount of mild detergent or approved non-caustic medical grade disinfectant wipes to clean the unit and charger according to local infection control regulations.

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.

Caution

•

Never immerse the AURICAL FreeFit probes into water or other cleaning solutions.

Caution

• No part of AURICAL FreeFit or its accessories is suitable for autoclaving or thermal disinfection/sterilization methods.

Probe tubes, tube guides and ear cords or ear hooks

These parts are in constant contact with your clients.

• Probe tubes:

The only part which is inserted into the ear canal during PMM testing is the Probe tube. These tubes are disposable, and should only be used once per client.

22


User Guide

• Tube guides and ear cords or ear hooks:

Use a soft, slightly damp cloth with a small amount of detergent to clean the ear cords or ear hooks and the tube guides.

Disposal

There are no special requirements regarding the disposal of the silicone test tubes, i.e. they can be discarded according to local regulations.

15.3

Maintenance

Annual calibration

FreeFit and the FreeFit probes must be calibrated once a year by your authorized service department.

16 Other references

For more information, see the online Help in OTOsuite, which contains detailed reference information about AURICAL

FreeFit and PMM, and other OTOsuite products.

For instructions on installing OTOsuite, see the OTOsuite Installation Manual, which you can find on the OTOsuite installation medium (disk or memory stick).

17 Technical specifications

AURICAL FreeFit

Type identification

AURICAL FreeFit is type 1053 from GN Otometrics A/S

Interface

Interface Wireless Bluetooth data transfer to PC, version 2.0, + EDR, class 2 (10 meters/33ft).

BT antenna

BT antenna:

Antenna gain:

Antenna impedance:

Chip multilayer antenna for 2.4 GHz

2 dBi

50 Ohm

The device supports Bluetooth SIG standards and uses features and functions from connected peripherals such as displaying the working status on the console from a Bluetooth connection.


23

User Guide

The device with Bluetooth technology, which operates in the same spectrum range in the 2.400 GHz-2.4835GHz (ISM band) as Classic Bluetooth technology, uses Bluetooth technology's 79 1-MHz wide channels. Within the channel, data is transmitted using Gaussian frequency shift modulation (GFSK), similar to Classic Bluetooth's Basic Rate scheme. The bit rate is 1 Mbit/s.

Power supply

Battery types:

Battery supply voltage:

Min. start-up:

Min. when running:

Low battery indicator level:

Estimated battery life:

Rechargeable, Ni-MH, AA (R6) 1.2V, 1 pc.(Use only rechargeable batteries supplied by GN Otometrics A/S). Can also be used with Alkaline AA (R6) 1.2V, 1 pc.

Nom. 1.30 V,

Max. 1.65 V,

1.10 V (Measured with instrument load)

1.00 V

When approximately 30 minutes of battery operating time remain.

5 hours of continuous use. (This is based on a typical use scenario. The actual use can influence the battery life time).

Accessories

• Test software. See the AURICAL FreeFit Service Manual.

Charger unit

Note

• This manual describes the assembly and use of the type 1053 charger unit. If you use the AURICAL speaker unit to charge your FreeFit, refer to the technical specifications in the manual for AURICAL Aud.

Type identification

Charger unit is type 1053 Charger from GN Otometrics A/S

Power supply

Nominal input voltage:

Min. input voltage:

Max. input voltage:

9 V DC

6.5 V DC

12 V DC

Max. power consumption while charging: 300 mA (at 9 V input voltage)

Max. power consumption when not charging:

60 mA (at 9 V input voltage)

External power adaptor

Power supply: BRIDGEPOWER CORP,

MENB1010A0903B01

Input voltage range: 100-240 V AC, 50-60 Hz

Output voltage range: 9 V DC, 1.10 A

24


User Guide

Power supply: DONGGUAN SHILONG

FUHUA ELECTRONIC CO., LTD., UE08WCP-

090056SPA



Power supply: DONGGUAN SHILONG

FUHUA ELECTRONIC CO., LTD.,

UES06WNCP-090060SPA



Use only the power adaptor supplied with the instrument.

Operating environment

Mode of operation:

Temperature:

Relative humidity:

Warm-up time:

Continuous.

+15°C to +35°C (59°F to +95°F)

30 to 90%, non-condensing

< 1 min.

Air pressure: 600 hPa to 1060 hPa

Operation at temperatures below -20°C or above +60°C may cause permanent damage.

Storing and handling

Temperature:

Rel. humidity:

Air pressure:

Dimensions

AURICAL FreeFit (HxWxD):

Charger unit (HxWxD):

-20°C to +60°C (-4°F to +140°F)

< 90%, non-condensing

500 hPa to 1060 hPa

23 mm x 350 mm x 230 mm (0.91 x 13.7 x 9.1 inches)

280 mm x 180 mm x 230 mm (11.4 x 7.1 x 9.1 inches) (with table plate mounted)

340 mm x 180 mm x 230 mm (13.8 x 7.1 x 9.1 inches) (with wall plate mounted)

Weight

AURICAL FreeFit:

Charger unit:

0.180 kg/0.40 lb

0.700 kg/1.54 lb

Essential performance

AURICAL FreeFit has no essential performance and accordingly, the applicable requirements are as stated in the following:

• Basic safety as defined by IEC 60601-1

All information required by IEC 60601-1-2:2007, #5.2.2.1-#5.2.2.10 is available in the AURICAL FreeFit User Guide.

Standards

Real Ear Measurement: EN 61669, ISO 12124


25

User Guide

Safety:

EMC:

IEC 60601-1, UL 60601-1, CAN/CSA -C22.2 NO 601.1-90

AURICAL FreeFit: IEC 60601-1, Internally Powered, Type BF, IPX0

IEC 60601-1-2, EN 300 328-2, EN 301 489-17

17.1

Accessories

Standard accessories and optional accessories vary from country to country - please consult your local distributor.

• REM Probes (2 pieces) - cable length approximately 20 cm (7.9 in)

• RECD Probes - short (2 pieces) - cable length approximately 20 cm (7.9 in)

• RECD Probe - long (1 piece) - cable length approximately 150 cm (5 feet)

• REM Probe Tubes (50 pieces)

• Silicone Ear Cords (50 pieces)

• Ear Hooks

• SoundHub 100

• Headphone, semi-closed (customer) - cable length approximately 250 cm (8 feet)

• Headset, open (dispenser) - cable length approximately 200 cm (6.5 feet)

• Table-top microphone (recording) - cable length approximately 300 cm (100 feet)

• NOAHlink straps

• Velcro clips

• Y-splitter adaptor cable

• REM tube support

• OTOsuite DVD

• OTOair Bluetooth Dongle

• RECD fitting kit (tubing and coupling)

• RECD Eartip starter kit

• AURICAL FreeFit Reference Manual

• AURICAL FreeFit User Guide

18 Manufacturer

GN Otometrics A/S

Hoerskaetten 9, 2630 Taastrup

Denmark

(

+45 45 75 55 55

7

+45 45 75 55 59 www.otometrics.com

26


User Guide

18.1

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 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.

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

19 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.

AURICAL FreeFit should only be provided with prescribed battery types, see

Powering the device ► 6

.

Place the battery as indicated in the battery compartment.

If you are using an alkaline battery, do not attempt to charge your AURICAL FreeFit. Your alkaline battery may be damaged and leak, and this may in turn cause damage to AURICAL FreeFit. Place FreeFit in the charger unit only if AURICAL FreeFit contains a rechargeable battery.

Batteries should be removed if equipment is not likely to be used for some time.

AURICAL FreeFit should only be charged using the type 1053 charger unit or the type 1081 AURICAL speaker unit from GN Otometrics A/S.

Unless you are charging AURICAL FreeFit with the AURICAL Aud speaker unit, which has a medically isolated power supply unit, do not attempt to use AURICAL FreeFit with clients while it is placed in the charger unit.

1. There are no user-serviceable parts inside the cabinet of the device or charger. 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.

2. 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.

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

4. 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 FreeFit be restricted.

5. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the equipment.

6. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential


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User Guide

installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

– Reorient or relocate the receiving antenna.

– Increase the separation between the equipment and receiver.

– Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

– Consult the dealer or an experienced radio/TV technician for help.

7. For use in Canada: To prevent radio interference to the licensed service, this device is intended to be operated indoors and away from windows to provide maximum shielding. Equipment (or its transmit antenna) that is installed outdoors is subject to licensing.

8. 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.

9. The device and charger unit can be disposed of as normal electronic waste, according to local regulations. Please investigate local regulations concerning the disposal of rechargeable and alkaline batteries.

10. For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system.

11. It is recommended that an annual calibration be performed on accessories containing transducers. Furthermore, it is recommended that calibration be performed if the equipment has suffered any potential damage (e.g. headphones dropped on the floor).

12. To comply with EN 60601-1-1 computer and printer must be placed out of reach of the client, i.e. not closer than approx. 1.5 meters/5 ft.

13. We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that the operation of the device is not affected.

14. In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician.

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

16. The charger unit should be kept away from the client area.

20 Notes on EMC (Electromagnetic Compatibility)

• AURICAL FreeFit 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 FreeFit.

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User Guide

Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems

AURICAL FreeFit is intended for use in the electromagnetic environment specified below. The user of AURICAL FreeFit should ensure that it is used in such an environment.

Emissions test

RF emissions

CISPR 11

Compliance

Group 1

RF emissions

CISPR 11

Harmonic emissions IEC 61000-3-2

Class B

Not applicable

Voltage fluctuations/flicker emissions IEC

61000-3-3

Not applicable

Electromagnetic environment - guidance

AURICAL FreeFit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

AURICAL FreeFit 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.

Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems


Immunity test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge

(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 humidity should be at least 30 %.

Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note

•

U

T is the AC mains voltage prior to application of the test level.


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User Guide

Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting


Immunity test IEC 60601 test level

Compliance level Electromagnetic environment - guidance

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m Portable and mobile RF communications equipment should be used no closer to any part of

AURICAL FreeFit, 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 transmitter in watts (W) according to the transmitter 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 FreeFit is used exceeds the applicable RF compliance level above, the AURICAL FreeFit should be observed to verify normal operation. If abnormal performance is observed, additional measures might be necessary, such as reorienting or relocating AURICAL FreeFit.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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User Guide

Recommended separation distances between portable and mobile RF communications equipment and AURICAL FreeFit

The AURICAL FreeFit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the

AURICAL FreeFit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AURICAL FreeFitas recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2

d = 2.3

0.01

0.1

1

0.12

0.38

1.2

0.23

0.73

2.3

10

100

3.8

12

7.3

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.

21 Definition of symbols

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.

Identifies the correct position of the battery inside the battery compartment.

Interference may occur in the vicinity of the device. Local regulations and precautions for other equipment in the environment should always be followed to avoid interference.

The separation distance from this device to other devices complying with standard immunity requirements in IEC 60601-1-2 is minimum 0.35 m/1ft.


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User Guide

Suitable for direct current only.

In France, it is only permitted to use the device indoors.

Consult user manual for warnings and cautions.

Follow instructions for use.

Consult instructions for use.

Complies with Type BF requirements of IEC60601-1.

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

Complies with the Radio Equipment and Telecommunications Terminal Equipment Directive 1999/5/EC.

The installation must be carried out in accordance with Medical Electrical Systems clause 16 in IEC 60601-

1 (3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-1-08-CAN/CSA. The supplementary provisions on the reliability of electro-medical systems.

It is a general rule for all electrical equipment used in the proximity of the client that:

• The connected equipment must comply with IEC 60601-1 (3rd).

This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:

• This device must not cause harmful interference.

• This device must accept any interference received, including interference that may cause undesired operation.

The term”IC” before the certification/registration number signifies that the Industry Canada technical specifications were met.

Do not reuse.

Used in error message dialogs if software program fails. See the detailed information in the dialog box.

Manufacturer and date of manufacture.

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