Service Manual Otoflex100

OTOflex 100

Service Manual

Doc no. 7-60-0116/02

0459

FM template version: 01-02-2010

Copyright noticeNo part of this Manual or program may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written con-sent of GN Otometrics A/S.

Copyright 2011, GN Otometrics A/SPrinted in Denmark by GN Otometrics A/S, DenmarkAll information, illustrations, and specifications in this manual are based on the latest product information available at the time of publication. GN Otometrics A/S reserves the right to make changes at any time with-out notice.

Version release date30. August 2011

Technical supportPlease contact your supplier.

Otometrics 65

8-14-8582 - Keyboard, parts list, p. 2

Pos. No. Description Part No.

Projekt : OTOFLEX

Page: 2

4-72-01600

4-72-02000

4-72-012

4-72-02300

4-72-012

4-72-012

IC1 IC,TCUT1200,Optical sensor 6-82-00700

IC37 IC,MAX4466EXK-T mic,op-amp SMD 6-58-04100

R1 RES,422R,1/8W,1%,MF,0603 3-54-00202

R2 RES,2.94K,1/8W,1%,MF,0603 3-54-00206

R3 RES,49.9R,1/8W,1%,MF,0603 3-54-00201

R4 RES,100K,1/8W,1%,MF,0603 3-54-00214

R5 RES,10K,1/8W,1%,MF,0603 3-54-00208

R6 RES,665K,1/8W,1%,MF,0603 3-54-00218

R7 RES,665K,1/8W,1%,MF,0603 3-54-00218

R8 RES,2.94K,1/8W,1%,MF,0603 3-54-00206

C1 CAP, ceramic 2.2UF/6.3V 10% SM

C2

C3

C4

C5

C6

CAP, ceramic 100NF/16V 10% SMD

Cond. ceramic 1nF 10% SMD

Cap,10nF,25V,10%,X7R,0603



Complist for: 8-14-8587#00

PCB Name : KEY BOARD

Parts List No: 8-14-85800

PCB No: 2-11-22200

Printed: 11-12-2003

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8-14-8584 - Keyboard, top & bottom view

Design

Drawn

Checked

Drawing No: Revision:

11-1

2-20

03 1

2:55

:04

PCB No: 2-11-22200 Parts List: 8-14-85800

OtoFlex KeyboardOTOFLEX

8-14-8584 /00

Page No:PCBIKP

IKP

CHH

TOP VIEW

BOTTOM VIEW

Otometrics 67

6 OTOflex 100 Calibration/Adjustment

6.1 Introduction to calibration/adjustment of OTOflex 100The OTOflex 100 consists of many features and must be set up and calibrated before use. All calibration and setup is done from the keypad and menu.

This chapter will guide you through setup and calibration of the OTOflex 100 with the help of the messages on the instrument display.

Note When you calibrate a transducer, you must complete the procedure before new data is saved.

Note OTOflex 100 must be calibrated annually.

The contra transducer (E-A-RTONE 3A or equivalent) has a built-in calibration chip, and can be connected to the instrument without recalibration as long as the cal-ibration is within the annual recalibration period.

The impedance probe has a built-in calibration chip, and can be connected to the instrument without calibration as long as the pressure system in the instrument is within the annual recalibration period.

6.1.1 Service menu access code

The default access code is 123. If you wish to change this access code:

1. Select Menu > Advanced > Service.See the OTOflex 100 Users

Reference Manual on howto use the text editor

2. Use the text editor to enter the default access code (123).3. Select Calibration.4. Select Change Access Code.5. Use the text editor to enter the new access code.

Note Make a note of the new access code for future reference!

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OTOflex 100 Calibration/Adjustment

Calibration features

6.2 Calibration features

Important If you leave the Calibration menu before saving the calibration, all new calibration data will be lost. Calibration can only be saved by using this menu item.

The calibrating routine consists of the following features:

Note The calibration routine is done in English.

1. To calibrate OTOflex 100 switch on the device and select Menu > Advanced > Service.

See the OTOflex 100 UsersReference Manual on how

to use the text editor

2. Use the text editor to enter the access code. Press OK.3. Press the right arrow softkey. The main Service menu appears.4. Select Calibration.5. The recommended sequence of selections from the Calibration menu is:

Altitude Pressure Method Standard Calibrate probe Calibrate contra

6.2.1 Altitude

1. From the Calibration menu, select Altitude.2. Press Select and then scroll to select the height in meters above sea level where

the device is calibrated (100 meters = approx. 330 ft).3. Press Select to confirm the selection. The height is stored.

6.2.2 Pressure

1. Connect a pressure gauge to OTOflex 100.2. From the Calibration menu, select Pressure.3. The OTOflex 100 automatically adjusts to a value as close to the target value

(+200 daPa) as possible. Use the Scroll Wheel to scroll to the exact target value. Read the pressure gauge to check the value.

4. Press the right arrow softkey. The OTOflex 100 automatically adjusts to a value as close to the target value (-400 daPa) as possible. Use the Scroll Wheel to scroll to the exact target value. Read the pressure gauge to check the value.

5. Press the right arrow softkey. 6. You are prompted to save the data. Press OK or Cancel.

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6.2.3 Method

1. From the Calibration menu, select Method.2. Select the calibration method for either SPL or HL: Press Select to toggle

between the values. SPL

OTOflex 100 is calibrated to a fixed SPL level and automatically calculates the HL level.

HLOTOflex 100 is calibrated to an SPL level plus the HL correction value.

3. Remember always to add the microphone correction values.OTOflex 100 can calibrate in both HL and SPL. OTOflex 100 is calibrated to SPL, because the measuring sound level meter measures the sound level in SPL. The dif-ference between HL calibration and SPL calibration is that in the SPL calibration the instrument makes all norm corrections automatically. You only have to set the needle of the sound level meter to the same fixed SPL value for all signals the correction value of the microphone.

This makes the calibration process very fast and reliable. This method is possible because the HL correction factors for most transducers are fixed and set in standards.

During HL calibration, OTOflex 100 is set to a given HL reading. The signal levels are adjusted to different values depending on the microphone correction and the HL correction. This method is very slow with the risk of calculating errors, etc. Accord-ingly, the instrument uses SPL calibration as default.

6.2.4 Standard

1. From the Calibration menu select Standard.2. Press Select and then use the Scroll Wheel to scroll to the appropriate value.

ISOCalibrate according to the ISO standard.

ANSICalibrate according to the ANSI standard.

CountryCountry-specific calibration. Reserved for future use.

3. Press Select to confirm your choice.

6.2.5 Calibrate probe

From the Calibration menu, select Calibrate probe...

Note This menu item applies only if a probe is connected.

From the Calibrate probe menu, you can access the following menu items:

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Info Probe tones IPSI stimulus Admittance calibration Save Save default

Info From the Calibration menu, select Calibrate probe... > Info

Info screen 1 provides the following information:

Transducer name Calibration date Serial no.

Step 1 Transducer type (internal number)Info screen 2 provides the following information:

Max HL values and HL corrections for all ipsilateral stimuli.Info screen 3 provides the following information:

Ipsi levels at 50 mV out of the device.Info screen 4 provides the following information:

Probe tone levels at 50 mV out of the device.Info screen 5 provides the following information:

Admittance coefficients.Info screen 6 provides the following information:

Microphone coefficients.Info screen 7 provides the following information:

Microphone phase coefficients.Info screen 8 provides the following information:

Microphone phase coefficients and altitude coefficients.

Probe tones From the Calibration menu select Calibrate probe... > Probe tones

Insert the probe into a 2.0 cc coupler with connected SPL meter.

Calibrate the 226 Hz, 678 Hz, 800 Hz and 1000 Hz probe tones by changing the offset.

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Important Keep the probe in the 2.0 cc coupler during the entire Probe tones calibra-tion and do not touch the probe cable.

Press Select and then use the Scroll Wheel to change the offset to the correct reading on the connected SPL meter.

Press the right arrow softkey to calibrate the subsequent probe tones. Repeat for all four frequencies.

Important When right arrow softkey is pressed, the probe microphone samples the probe tone in the 2.0 cc coupler. To ensure an undisturbed sample, do not touch the cable.

When you have calibrated the probe tones, press the left softkey and return to the main calibration menu.

Ipsi stimulus From the Calibration menu, select Calibrate probe... > IPSI stimulus

Calibrate 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN, HPN, LPN stimuli by changing the offset.

Press Select and then use the Scroll Wheel to change the offset to the correct reading on the connected SPL meter.

Press the right arrow softkey to calibrate the subsequent stimulus. When you have calibrated the stimuli, press the left softkey and return to the

main calibration menu.

Admittance calibration From the Calibration menu select Calibrate probe... > Admittance cal

Press Select to start admittance calibration. Insert the probe in a 0.5 cc hard-wall cavity and press the right arrow softkey.

Wait a few seconds. Insert the probe in a 2.0 cc hard-wall cavity and press the right arrow softkey.



Wait a few seconds. When you have calibrated the admittance values, press the left softkey and

return to the main calibration menu.

Save From the Calibration menu select Calibrate probe... > Save

When you have finished calibrating, select this item to save the calibration. A message appears stating that the calibration data is saved.

Data on stimuli, probe tones and admittance are stored in the probe.

72 Otometrics



Data on pressure is stored in the device.


6.2.6 Calibrate contra insert phone

From the Calibration menu select Calibrate contra...

Note This menu item applies only if a contra insert phone is connected.

From the Calibrate contra menu you can access the following menu items:

Info Contra stimulus Save

Info From the Calibration menu select Calibrate contra... > Info


Transducer name Calibration date Serial no. (six-digit number on the contra transducer) Transducer type (internal number)


Max HL values and HL corrections for all contralateral stimuli.Info screen 3 provides the following information:

Contra levels at 50 mV out of the device.

Contra stimulus From the Calibration menu select Calibrate contra... > Contra stimulus

Calibrate 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, BBN, HPN, LPN stimuli by changing the offset.

Press Select and use the Scroll Wheel to change the offset to the correct read-ing on the connected SPL meter.

Press the right arrow softkey to calibrate the subsequent stimulus. When you have calibrated the stimuli, press the left softkey and return to the

main calibration menu.

Save From the Calibration menu select Calibrate contra... > Save

Otometrics 73


Calibration tools

When you have finished calibrating, select this item to save the calibration. A message appears stating that the calibration data is saved.

Data on stimuli, probe tones and admittance are stored in the probe. Data on pressure is stored in the device.


6.3 Calibration tools

6.3.1 Standard equipment needed:

Pressure Meter Sound Level Meter Pre-amp for mic. Pressure-field mic. Alternatives:

B&K Type 4144 (1) G.R.A.S. Type 40EN (1) G.R.A.S. Type 40AG (1/2)

6.3.2 PROBE

Equipment needed for calibrating the impedance probe: Admittance calibration: Cavity set: Otometrics part 8-67-41300 IEC 60126/ANSI S3.7 2cc coupler. Three alternatives:

B&K Type DB0138 for 1 mic and Otometrics part 8-67-290 adaptor. G.R.A.S. Type RA0113 for 1 mic and G.R.A.S. Type RA0120 adaptor. G.R.A.S. Type RA0038 for 1/2 mic and G.R.A.S. Type RA0121 adaptor.

Angled test base for vertical positioning of 2cc coupler (recommended). E.g. G.R.A.S. Type RA0070 or an Artificial Ear, e.g. B&K Type 4152 (1) (includes DB0138 and 4144) or G.R.A.S. Type 43AB (1/2) (includes RA0038 and 40AG).

Grey 11 mm eartip mounted on probe to fit in the adaptor.

6.3.3 E-A-RTONE 3A or equivalent

Equipment needed for calibrating the insert phone: Artificial Ear B&K Type 4152 or G.R.A.S. Type 43AF IEC 60126/ANSI S3.7 2cc coupler. Three alternatives:

B&K Type DB0138 for 1 mic.

74 Otometrics


Licenses

G.R.A.S. Type RA0113 for 1 mic. G.R.A.S. Type RA0038 for 1/2 mic.

Angled test base for vertical positioning of 2cc coupler (recommended).

6.4 Licenses1. To add or remove OTOflex 100 services, switch on the device and then select

Menu > Advanced > Service.See the OTOflex 100 Users

Reference Manual on howto use the text editor

2. Use the text editor to enter the access code. Press OK.3. Press the right arrow softkey. The main Service menu appears.4. Select Licenses.5. From the Licenses menu you can access:

Add feature Remove feature

6.4.1 Add feature

Note Adding a feature in OTOflex 100 requires a unique license key.

See the OTOflex 100 UsersReference Manual on how

to use the text editor

1. In the Add feature screen use the text editor to enter the unique license key.2. When you have entered the license key, press the right arrow softkey. The new

feature is automatically added and is now available in the OTOflex 100 configu-ration.

6.4.2 Remove feature

1. In the Remove feature screen use the Scroll Wheel to go to the feature to be removed.

2. Press Select. A pop-up menu asks you to press Cancel, or OK to confirm.

Note Adding a removed feature in OTOflex 100 requires a unique license key.

Rubber seal

Nipple

DB 013818 mm ear mould coupler

Otometrics 75

7 Technical Specifications

7.1 OTOflex 100

7.1.1 Compliance measuring system

Probe tone:226Hz @ 85dBspl 1.5dB1000Hz @ 75dBspl 1.5dB

THD:< 3% in 2 cc

Frequency accuracy:0.5%

Range:0.1 ml to 8.0 ml 5% or 0.1 ml whichever is greater

7.1.2 Acoustic Reflex

7.1.2.1 Contralateral Stimulation

Pure tones:500Hz, 1000Hz, 2000Hz, 3000Hz, 4000Hz

Frequency accuracy: 0.5%

NoiseWhite Noise according to IEC 1027Low Pass 400 to 1600 Hz.High Pass 1600 to 4000 Hz.Roll off >12 dB/Octave.

Range at:BBN, LPN at 50 to 100 dB HL 3 dBHPN at 50 to 95 dB HL 3 dB

Step size dB1, 2, 5, 10 dB

Contra insert (E-A-RTONE 3A or equivalent):

Range at:500Hz at 50 to 105dB HL 3dB1000Hz at 50 to 120dB HL 3dB2000Hz at 50 to 115dB HL 3dB

76 Otometrics

Technical Specifications

OTOflex 100

3000Hz at 50 to 105dB HL 3dB4000Hz at 50 to 110 dB HL 3dB

THD:< 3% in 2 cc (measured 5 dB below max output)

Immittance probe:

Range at:500Hz at 50 to 105dB HL 3dB1000Hz at 50 to 120dB HL 3dB2000Hz at 50 to 115dB HL 3dB3000Hz at 50 to 105dB HL 3dB4000Hz at 50 to 110 dB HL 3dB


7.1.2.2 Ipsilateral Stimulation

Tone:500Hz, 1000Hz, 2000Hz, 3000Hz, 4000Hz

Frequency accuracy: 0.5%

NoiseWhite Noise according to IEC 1027Low Pass 400 to 1600 HzHigh Pass 1600 to 4000 HzRoll off >12 dB/Octave

Step size dB:1, 2, 5, 10 dB

Range at:500Hz at 50 to 105dB HL 3dB1000Hz at 50 to 120dB HL 3dB2000Hz at 50 to 115dB HL 3dB3000Hz at 50 to 105dB HL 3dB4000Hz at 50 to 110 dB HL 3dB


7.1.3 Air pressure system

Range:Normal +200 to -400 daPa/s, Extended +400 to -600 daPa/s

Pressure sweep rate:50, 100, 200, 400 daPa/s, A.F.A.PA.F.A.P. will start at 500 daPa/s and slow down to 400 daPa, when at peak is detected.

Pressure accuracy: 10% or 10 daPa, whichever is greatest

Otometrics 77


Charger unit

Pump measure direction:Positive to negative or negative to positive

Safety:Separate safety +530 daPa and -730 daPa. 70 daPaSoftware safety +450 daPa and -650 daPa. 70 daPa.

7.1.4 Unit of admittance graph Y-axis

ml, cc, mmho, l

7.1.5 Unit of graph X-axis

daPa, sec

7.1.6 Display

Graphic 128x128 dots

7.1.7 Interface

Wireless Bluetooth data transfer to PC

7.1.8 Type identification

OTOflex 100 is type 1012 from GN Otometrics A/S

7.1.9 Power supply

Battery types:Rechargeable (Ni-MH type) AA (R6) 1.2V, 4 pcs. Use only rechargeable batteries supplied by GN Otometrics A/SAlkaline AA (R6) 1.5V, 4 pcs.

Battery supply voltage:Nom. 5V, max. 6.4V, min. 4.0V (instrument power off volt-age)

Low battery indicator level:To be specified

Estimated battery life:To be specified

7.1.10 Dimensions and weight

Dimensions:To be specifiedWeight:To be specified

7.2 Charger unitType identification:Charger unit is type 1012 Charger from GN Otometrics A/S

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Operating environment

Power:100 - 240 VAC 10%, 50/60 Hz

Power consumption< 10VA

7.3 Operating environmentTemperature:+15C to +35C (59F to +95F)

Rel. humidity:30 to 90 %, non-condensing

Warm-up time:< 2 min.

Air pressure:600 hPa to 1060 hPa

Operation at temperatures below -20C or above +60C may cause permanent dam-age.

7.4 Storing and handlingTemperature:-20C to +60C (-4F to +140F)

Rel. humidity:< 90 %, non-condensing

Air pressure:500 hPa to 1060 hPa

7.5 DimensionsOTOflex 100 (HxWxD):20 cm x 4.9 cm x 7.8 cm (7.9 x 1.9 x 3.0)

Charger unit (HxWxD):18 cm x 4.9 cm x 7.8 cm (6.9 x 1.9 x 3.0)

7.6 WeightOTOflex 100:0.6 kg/1.3 lb

Charger unit:0.23 kg/0.5 lb

7.7 Miscellaneous2cc coupler.

Clock and calendar.

Otometrics 79


Calibration

7.8 CalibrationEquipment should be calibrated regularly according to EN 61027 and ANSI S3.39

7.9 StandardsSafety:EN 60601-1, UL 2601-1, CAN/CSA -C22.2 NO 601.1-90

OTOflex 100: EN 60601-1, Class II, Internal Powered, Type BF, IPX0

Charger unit: EN 60601-1, Class II, IPX0

EMC:EN 60601-1-2, EN 300 328-2, EN 301 489-17

Impedance/Admittance:EN 61027 Type 1, ANSI S3.39 Type 1

80 Otometrics


Standards

Otometrics 81

Index

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

IndexAAccess code 67

change default 67Altitude 68Assembly, charger 28Assembly, OTOflex 100 18

CCalibration 6768

altitude 68contra 72contra insert phone info 72method 69pressure 68probe 69probe admittance 71probe contra stimulus 72probe info 70probe ipsi stimulus 71probe tones 70save probe calibration 7172standard 69

Calibration flowchart 73CE marking 8Component placement, overview 14Contra insert phone

calibration 72calibration info 72

DDisassembly, charger 28Disassembly, OTOflex 100 17

EE-A-RTONE 73

MManufacturer 11

responsibility 11

Mechanics 17

PPlatform 31Pressure

calibration 68Probe

admittance calibration 71calibration 69calibration contra stimulus 72calibration info 70calibration ipsi stimulus 71calibration tones 70save calibration 7172

SSafety 7

CE marking 8Medical Devices Directive 8warning notes 9

Specifications, technical 75System description 13

TTechnical specifications 75Tools 17

WWarning notes 9

82 Otometrics

Index

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
OTOflex 100

Service Manual Otoflex100

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