Audioscan Verifit User Manual

4 (1)

Audioscan Verifit®

User's Guide 3.12

ã May 2015

Table of Contents

 

1

About Verifit..........................................................................................................................................................................

6

 

New in this software release................................................................................................................................................

6

 

Product description...............................................................................................................................................................

6

 

Associated items and supplies..............................................................................................................................................

7

 

SAFETY WARNINGS and NOTICES................................................................................................................................

7

 

Environmental safety............................................................................................................................................................

8

 

Declaration of Electromagnetic Compatibility (EMC).......................................................................................................

8

 

Warranty, Trademarks, Acknowledgments.........................................................................................................................

9

 

EC Declaration of Conformity...........................................................................................................................................

11

 

Electronic User’s Guide.....................................................................................................................................................

12

 

How to Avoid Undesirable Side Effects............................................................................................................................

12

2

Getting Started.....................................................................................................................................................................

14

 

Unpacking and connecting.................................................................................................................................................

14

 

Microphone connection......................................................................................................................................................

15

 

General care instructions....................................................................................................................................................

16

 

Microphone care.................................................................................................................................................................

16

 

Battery pill use and care.....................................................................................................................................................

17

 

Mouse, keyboard, barcode scanner....................................................................................................................................

17

 

Monitor headphones...........................................................................................................................................................

18

 

External peripherals............................................................................................................................................................

18

3

General Operation................................................................................................................................................................

20

 

Input device operation........................................................................................................................................................

20

 

Barcode data input..............................................................................................................................................................

20

 

Keypad keys........................................................................................................................................................................

21

 

Menus, lists and buttons.....................................................................................................................................................

22

 

Screen messages and Help.................................................................................................................................................

22

 

Software updating...............................................................................................................................................................

23

4

General Setup.......................................................................................................................................................................

24

 

Date and time setup............................................................................................................................................................

24

 

Display settings...................................................................................................................................................................

24

 

Saving test setup.................................................................................................................................................................

24

5 Networking...........................................................................................................................................................................

26

 

Networking requirements...................................................................................................................................................

26

 

Networking setup................................................................................................................................................................

26

 

NOAH Service Port............................................................................................................................................................

27

 

Changing the NOAH service port......................................................................................................................................

27

 

Testing the NOAH service port..........................................................................................................................................

28

6

Single computer connection................................................................................................................................................

29

 

Automatic connection (recommended)..............................................................................................................................

29

 

Static connection................................................................................................................................................................

29

7

Printing and Storing Results................................................................................................................................................

31

 

Internal printer paper loading.............................................................................................................................................

31

 

Barcodes, tabular data, headers and comments on printouts............................................................................................

32

 

Local printer setup..............................................................................................................................................................

33

 

Printing to USB memory....................................................................................................................................................

33

 

Network printer setup.........................................................................................................................................................

34

 

Printing to a network file....................................................................................................................................................

34

 

Storing and restoring data – setup......................................................................................................................................

35

 

Storing and restoring data..................................................................................................................................................

36

 

Data storage using NOAH..................................................................................................................................................

37

8

Test Box Measures - Setup..................................................................................................................................................

38

 

Test box screen...................................................................................................................................................................

38

 

Format.................................................................................................................................................................................

39

 

Scale....................................................................................................................................................................................

39

 

Hide or Show test box curves.............................................................................................................................................

39

 

1996 or 2003 ANSI standard..............................................................................................................................................

39

 

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ANSI test frequencies.........................................................................................................................................................

40

 

Test box calibration facts...................................................................................................................................................

40

 

Calibrating test box reference microphone........................................................................................................................

41

 

Calibration check for coupler microphone........................................................................................................................

42

 

Coupling the hearing instrument for ANSI tests...............................................................................................................

43

 

Coupling the hearing instrument for Test box Speechmap...............................................................................................

43

 

Positioning the hearing instrument....................................................................................................................................

44

9 ANSI Hearing Aid Tests......................................................................................................................................................

45

 

ANSI S3.22-1996 facts.......................................................................................................................................................

45

 

ANSI S3.22-2003 facts.......................................................................................................................................................

45

 

ANSI 1996 Linear and AGC tests......................................................................................................................................

46

 

ANSI 2003 Linear and AGC tests......................................................................................................................................

46

 

ANSI test results.................................................................................................................................................................

47

 

ANSI input-output curves..................................................................................................................................................

47

 

ANSI telecoil terminology.................................................................................................................................................

48

 

ANSI telephone simulator (TMFS) test.............................................................................................................................

49

 

ANSI test loop test..............................................................................................................................................................

50

10

Telecoil test results.............................................................................................................................................................

50

Other Test Box Measures..................................................................................................................................................

52

 

Harmonic distortion............................................................................................................................................................

52

 

Noise reduction...................................................................................................................................................................

52

 

Feedback suppression test..................................................................................................................................................

53

 

Directional function test.....................................................................................................................................................

54

 

Directional ITE positioning................................................................................................................................................

55

 

Directional BTE positioning..............................................................................................................................................

55

 

Test box directional procedure...........................................................................................................................................

56

 

Multicurve procedure.........................................................................................................................................................

57

 

Multicurve results...............................................................................................................................................................

57

 

Spectral analysis in Multicurve..........................................................................................................................................

58

 

Battery drain test................................................................................................................................................................

58

 

Manual control procedure..................................................................................................................................................

59

11

Sound level meter using manual control...........................................................................................................................

60

Sensory loss simulator.......................................................................................................................................................

62

 

Sensory loss simulator description.....................................................................................................................................

62

12

Sensory loss simulator operation.......................................................................................................................................

62

On-Ear Measures - Setup...................................................................................................................................................

63

 

External sound-field speaker setup....................................................................................................................................

63

 

On-ear calibration facts......................................................................................................................................................

63

 

Calibration of on-ear probe microphone............................................................................................................................

64

 

Calibration check for probe module..................................................................................................................................

65

 

Max TM SPL setup............................................................................................................................................................

66

 

ABR nHL to eHL setup......................................................................................................................................................

67

 

Positioning the client..........................................................................................................................................................

67

13

Positioning the probe tube..................................................................................................................................................

68

On-Ear Measures Screen Setup.........................................................................................................................................

70

 

On-ear single or dual view.................................................................................................................................................

70

 

Graph, table or 2cc target format.......................................................................................................................................

71

 

SPL or HL scale..................................................................................................................................................................

71

14

Hide or show on-ear curves................................................................................................................................................

71

On-Ear Instrument Measures.............................................................................................................................................

73

 

On-ear directional test overview........................................................................................................................................

73

 

On-ear directional testing...................................................................................................................................................

73

 

 

 

 

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Verifit®User's Guide Version 3.12 ã May 2015

 

On-ear feedback test...........................................................................................................................................................

74

 

On-ear noise reduction test.................................................................................................................................................

74

 

On-ear manual control........................................................................................................................................................

75

15

Sound level meter using on-ear microphones....................................................................................................................

76

Occlusion Effect Test.........................................................................................................................................................

78

 

Occlusion effect measurement...........................................................................................................................................

78

16 RECD measurement...........................................................................................................................................................

79

 

Calibration of RECD transducer........................................................................................................................................

79

 

Measure RECD ..................................................................................................................................................................

80

 

RECD results......................................................................................................................................................................

81

 

ANSI S3.46(2013) RECD .................................................................................................................................................

82

 

RECD protocols..................................................................................................................................................................

82

17

RECD facts.........................................................................................................................................................................

84

Insertion Gain.....................................................................................................................................................................

85

 

Insertion gain in SPL..........................................................................................................................................................

85

 

Insertion gain in HL...........................................................................................................................................................

86

 

Audiometric data entry.......................................................................................................................................................

86

 

REUR measurement procedure..........................................................................................................................................

87

 

REAR measurement procedure..........................................................................................................................................

88

 

SII calculation in Insertion gain.........................................................................................................................................

89

 

CROS fitting using Insertion gain......................................................................................................................................

89

18 Speechmap.........................................................................................................................................................................

91

 

Speechmap facts.................................................................................................................................................................

91

 

DSL 5.0 in Speechmap.......................................................................................................................................................

91

 

DSL 5.0 changes.................................................................................................................................................................

92

 

NAL-NL1 in Speechmap....................................................................................................................................................

92

 

NAL-NL2 in Speechmap....................................................................................................................................................

92

 

Camfit in Speechmap.........................................................................................................................................................

93

 

Using Speechmap...............................................................................................................................................................

93

 

Speechmap Setup................................................................................................................................................................

94

 

Screen tour - unaided screen..............................................................................................................................................

95

 

Screen tour - aided screen..................................................................................................................................................

96

 

On-ear or Test box mode....................................................................................................................................................

96

 

SII calculation in Speechmap.............................................................................................................................................

97

 

Using custom stimuli in Speechmap..................................................................................................................................

97

19

Creating WAV files for Speechmap..................................................................................................................................

99

Speechmap Fitting Procedures........................................................................................................................................

101

 

Assessment data entry......................................................................................................................................................

101

 

Assessment data choices..................................................................................................................................................

102

 

Fitting to targets for soft speech.......................................................................................................................................

103

 

Fitting to targets for loud sounds.....................................................................................................................................

104

 

Fitting to targets for mid-level speech.............................................................................................................................

104

 

Open fittings in Speechmap.............................................................................................................................................

105

 

Verifying Frequency Compression/ Frequency-Lowering Hearing Instruments in Speechmap....................................

105

 

FM fitting and verification...............................................................................................................................................

107

 

CROS fitting in Speechmap.............................................................................................................................................

108

20

T-Loop fitting and verification in Speechmap................................................................................................................

109

Speechmap Technical Details..........................................................................................................................................

112

 

Speechmap stimuli...........................................................................................................................................................

112

 

Stimulus levels..................................................................................................................................................................

112

 

Microphone location effects.............................................................................................................................................

113

 

Deep insertion compensation...........................................................................................................................................

114

 

 

 

 

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Speech signal analysis......................................................................................................................................................

114

21

Viewport...........................................................................................................................................................................

115

 

Viewport setup..................................................................................................................................................................

115

 

Accessing Viewport tests.................................................................................................................................................

116

 

Viewport Audibility test...................................................................................................................................................

116

 

Viewport Test box directional test...................................................................................................................................

117

 

Viewport Test box feedback test......................................................................................................................................

120

 

Viewport On-ear feedback test.........................................................................................................................................

121

22

Troubleshooting...............................................................................................................................................................

123

 

Self test failures................................................................................................................................................................

123

 

Initialize Function............................................................................................................................................................

123

 

Test box high distortion or noise......................................................................................................................................

124

 

Test box curves inconsistent............................................................................................................................................

124

 

Test box curves differ from specifications......................................................................................................................

124

 

Test box speaker overdriven............................................................................................................................................

125

 

No test box reference mic. detected.................................................................................................................................

125

 

Invalid test box calibration...............................................................................................................................................

125

 

No on-ear ref. mic. detected.............................................................................................................................................

125

 

Invalid on-ear calibration.................................................................................................................................................

126

 

Sound-field speaker overdriven.......................................................................................................................................

126

 

Barcode scanner malfunction...........................................................................................................................................

126

23

Technical Specifications..................................................................................................................................................

129

24

Glossary............................................................................................................................................................................

132

25

References........................................................................................................................................................................

137

26

Appendix 1.......................................................................................................................................................................

140

 

Manufacturer Disclosure Statement for Medical Device Security.................................................................................

140

27

Appendix 2.......................................................................................................................................................................

143

 

AudioNote 2.1 VERIFIT and RM500SL Test Signals and Analysis..............................................................................

143

5

Verifit®User's Guide Version 3.12 ã May 2015

1 About Verifit

This section provides a listing of features new in this software release, describes the Audioscan Verifit, provides contact, warranty and trademark information, safety warnings and notices and instructions for accessing the electronic User’s Guide.

Note that the User's Guide may be viewed on the Verifit at any time by pressing <Help>. (For long Help pages,

use <Left/Right> (or mouse) to switch between the Help index and the Help page and

arrows (or mouse) to

scroll through the page).

 

New in this software release

Software 3.12 introduces the following significant additions and changes:

1.NAL-NL2 prescription formula. For details, see 17. NAL-NL2 in Speechmap.

2.User-supplied test signals. For details see 17. Using custom stimuli in Speechmap

3.Inductive stimulus in Speechmap for adjusting tcoils for use with room loops. For details see 18. T-Loop fitting and verification in Speechmap.

4.New Directional Test works with feedback cancelers and frequency-lowering devices.

5.Improved audioscan updater. USB memory sticks left plugged in will not interfere with startup.

Product description

The Verifit is a hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearing aid specialists to verify the electro-acoustic performance of a hearing aid connected to a standard earphone coupler or while worn on the ear of the end user. It consists of:

a) an acoustically-treated test chamber which houses a battery substitute (1.3 volt supply), 2 loudspeakers, a reference microphone for controlling the signal from the loudspeakers, a standardized earphone coupler connected to a measuring microphone for the purpose of measuring the sound level produced in the standard coupler by a hearing aid and a custom keypad.

b)an analyzer/display unit housing a flat-panel video display, power supply, signal generation, measurement and control electronics and two sound-field loudspeakers.

c)two real-ear measurement microphone assemblies, each housing a reference microphone for controlling the signal from the sound-field speakers and a probe microphone connected to a thin silicone tube which may be

inserted into the ear canal for the purpose of measuring the sound level in the ear canal produced by a hearing aid.

d) a miniature earphone used to measure the real-ear to coupler difference (RECD) useful in estimating the sound level produced in an individual ear from measurements in the standard earphone coupler.

The analyzer attaches to the acoustic test chamber via two 15-conductor cables. The acoustic test chamber provides connectors for the microphones used for controlling the stimulus and measuring the response. For HIT mode, a reference microphone, coupler microphone and a battery simulator are normally connected via connectors provided inside the acoustic test chamber. For REM mode, two probe modules – each containing a reference microphone and a measurement microphone, and a real-ear to coupler difference (RECD) earphone are normally connected via connectors situated on the front of the acoustic test chamber. A connector and volume control for headphones, used to monitor coupler and probe microphone signals, are provided on the front right side of the test chamber.

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Verifit®User's Guide Version 3.12 ã May 2015

There are connectors on the rear of the main display unit for 4 USB devices (flash drives, a QWERTY keyboard, mouse, printer, barcode scanner), external speakers, an external HDMI monitor and connection to a network (LAN) (serial number 4671 and higher). Units with serial number below 4671 have connectors for 2 USB devices, an external VGA monitor, parallel printer, external speakers, a local area network (LAN) and an RS223 serial port (not supported in this version of software).

Electrical supply input requirement: 100 – 240 Vac 47 – 63 Hz 250VA A hospital grade grounded outlet is required.

Associated items and supplies

VA-100 Soft case for Verifit

VA-111 External speaker with folding stand and clips for microphone extension cables

VA-120 Barcode scanner for reading barcoded audiometric data on printouts from Audioscan analyzers VA-131 Microphone extension cable (3') for use with Audioscan analyzers

VA-133 Microphone extension cable (10') for use with Audioscan analyzers

VA-201 NOAH® module allows a networked PC running NOAH to exchange data with Audioscan analyzers RE201-25 Thermal printer paper for the internal printer in the Verifit

RE367-36 Probe microphone tubes for single patient use (36 per bag)

SAFETY WARNINGS and NOTICES

For purposes of IEC 60601-1, this product is Class I with Type BF applied part.

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

(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation

This Class A digital apparatus complies with Canadian ICES-003

WARNING: To avoid the risk of electric shock, this product must be connected only to a supply mains with protective earth (ground).

WARNING: To avoid the risk of electrical shock, any line-powered peripheral equipment connected to this product must comply with UL/IEC 60601-1 OR comply with UL or IEC and ISO safety standards for such equipment AND a) be operated from an isolating transformer complying with UL/IEC 60601-1 OR b) be kept at least 6 feet (1.8 m) from the patient.

WARNING: This equipment is not suitable for use in an oxygen-rich environment or in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide.

WARNING: No modification of this equipment is permitted

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Verifit®User's Guide Version 3.12 ã May 2015

This symbol on the product is a WARNING that failure to follow instructions in this part of the User’s and/or Quick Start Guides could place the operator or patient at risk.

This symbol on the product means that the parts applied to the patient meet the safety requirements of IEC 60601-1 for type BF isolated (floating) applied parts

Environmental safety

This symbol on the product means that this product is not to be disposed of in unsorted municipal waste because electrical and electronic waste may contain hazardous substances which could endanger the environment and human health.

This product and its associated items must be disposed of in accordance with local disposal regulations for electrical and electronic waste. Consult your local waste disposal authority regarding applicable regulations.

The microphone probe tubes and the foam eartips used with the RECD transducer are for single patient use. After use, they may be disposed of in unsorted municipal waste or as required by your facility's waste management policy.

Declaration of Electromagnetic Compatibility (EMC)

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the following information:

The Verifit should not be used adjacent to or stacked on other equipment. If this is necessary, its operation should be verified as normal in this configuration.

Portable and mobile RF communications equipment can affect medical electrical equipment and may affect the performance of the Verifit.

Performance degradation due to electromagnetic disturbances (including electrostatic discharge) is considered normal and acceptable

The compliances listed in the following table are met with the supplied RECD transducer, microphones, headphones, mouse and keyboard connected and with unterminated speaker cables (2), USB cables (2), Ethernet cable, parallel printer cable, serial cable and VGA display cable connected. The connection of other devices may result in increased emissions.

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Verifit®User's Guide Version 3.12 ã May 2015

Guidance and manufacturer’s declaration - electromagnetic emissions

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

Emissions test

 

Compliance

Electromagnetic environment - guidance

 

 

 

 

RF emissions

 

 

The Verifit uses RF energy only for internal function.

 

Group 1

Therefore RF emissions are very low and not likely to

CISPR 11

 

 

 

cause any interference in nearby electronic equipment.

 

 

 

RF emissions

 

Class A

 

CISPR 11

 

The Verifit is suitable for use in all establishments

 

 

Harmonic emissions

 

 

 

Class A

other than domestic and those directly connected to

IEC 61000-3-2

 

 

 

the public low-voltage power supply network that

Voltage fluctuations/

flicker

 

 

supplies buildings used for domestic purposes.

emissions

 

Complies

 

 

IEC 61000-3-3

 

 

 

Warranty, Trademarks, Acknowledgments

The Audioscan Verifit is manufactured by Etymonic Design Inc., 20 Ludwig St., Dorchester, Ontario, Canada, N0L 1G4. Web site www.audioscan.com.

Phone: 800-265-2093 (USA only); 519-268-3313 Fax: 519-268-3256 Email: info@audioscan.com or service@audioscan.com

The authorized representative for this product in the European Community is: P.C. Werth, Audiology House, 45 Nightingale Lane, London, UK, SW12 8SP. Phone: +44 (0) 181-675 5151 Fax +44 (0) 181-675 7577.

Warranty: The Verifit is warranted against defects for two years from date of purchase. Within this period, it will be repaired without charge for parts, labor or return shipping when returned prepaid to your authorized Audioscan service agent. This warranty does not apply to equipment that, in our sole judgment, has been subject to misuse, or unauthorized alteration or repair.

This warranty does not apply to battery substitutes (pills), which carry a 90 day warranty. This warranty does not cover battery substitutes used in a hearing aid manufacturing facility.

Trademarks:

Audioscan, Axiom, Speechmap, Verifit and Viewport, are registered trademarks of Etymonic Design Inc. DSL is a registered trademark of the University of Western Ontario. All rights reserved. HP LASERJET is a registered trademark of Hewlett-Packard Company. NOAH is a registered trademark of the Hearing Instrument Manufacturer's Software Association. QUEST is a trademark of Quest Technologies Inc. PostScript is a registered trademark of Adobe Systems, Inc.

Acknowledgments:

DSL 5.0 is used under license from the University of Western Ontario (UWO) which is solely responsible for its content. We acknowledge the support received from past and present staff at the National Centre for Audiology at UWO in implementing the DSL method.

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Verifit®User's Guide Version 3.12 ã May 2015

CAMFIT is used under license from Prof. Brian C.J. Moore, University of Cambridge, UK. We are indebted to the University of Memphis Hearing Aid Research Laboratory for permission to use some of their recorded speech material.

NAL-NL1 is used under license from the National Acoustics Laboratories, Australia. NAL-NL2 is used under license from Hearworks Pty Ltd, Australia.

Software licenses:

Audioscan distributes selected software components under various open source licenses. These licenses generally give you the right to copy and change the affected component's software source code. For details, see the license files distributed with the software, or contact Audioscan.

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Audioscan Verifit User Manual

Verifit®User's Guide Version 3.12 ã May 2015

EC Declaration of Conformity

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Verifit®User's Guide Version 3.12 ã May 2015

Electronic User’s Guide

You can download the current User's Guide directly from www.audioscan.com. A printable User's Guide is also provided with each new instrument and each software update. A .pdf file viewer, such as Acrobat Reader (5.0 or higher) or Foxit Reader is required to view the User’s Guide. Except for some additional reference material, the information in the User's Guide is available to you at any time by pressing <Help> on the Verifit.

If your Verifit does not have a built-in CD drive (serial number 4671 and higher), a printable User’s Guide is on the updater USB flash drive supplied with the instrument. This User's Guide will be updated each time you download new software from www.audioscan.com to the updater USB flash drive.

To view the User's Guide:

1.Insert the updater USB flash drive into a USB port on your PC.

2.If your PC does not open the flash drive automatically, select My Computer, then the Removable Disk drive (usually E or F).

3.Double click the User_Guide folder to open it.

4.Double click the english folder and copy the Verifit Users Guide.pdf file to an appropriate location on your PC. Double click on the file to open it for viewing.

When you have finished copying the file from the USB flash drive, click on the safely remove icon on your PC and remove the flash drive when you are notified that it is safe to do so.

STORE THE UPDATER USB FLASH DRIVE IN A SAFE PLACE. YOU WILL REQUIRE IT TO INSTALL FUTURE SOFTWARE UPDATES.

If your Verifit has a CD drive (serial # less than 4671), a printable User's Guide will be on the update CD-ROM which was mailed to you (on request) or which you created from a software download from

www.audioscan.com.

To view the User's Guide:

1.Insert the CD-ROM into the CD drive on your PC.

2.Select My Computer, then the CD drive and the User's Guide folder.

3.Double click the english folder and copy the Verifit Users Guide.pdf file to an appropriate location on your PC. Double click on the file to open it for viewing.

The User's Guide may also be downloaded from www.audioscan.com.

See Software updating for instructions on installing and removing the CD-ROM.

How to Avoid Undesirable Side Effects

During the development of the hearing aid analyzer, Audioscan performed a rigorous Risk Assessment to identify any undesirable side effects that a user could be exposed to during the use of the Verifit, and incorporated numerous risk reduction design elements into the Verifit to minimize the risk to users and patients.

Following are the actions which a user should take to ensure that these risk control measures continue to be effective

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Verifit®User's Guide Version 3.12 ã May 2015

Loud Sounds:

The Verifit is designed to produce sound pressure levels as high as 85 dB at the probe reference microphone. Exposure to these levels for more than 7 hours can produce hearing damage. When such levels are amplified by a hearing aid, the level in the ear canal will be determined by the settings of the hearing aid but may reach levels that can produce hearing damage in less than 30 seconds. To avoid this possibility,

1.hearing aids should be adjusted to limit sound pressure levels to safe levels

2.the maximum TM SPL setting (see Max TM SPL Setup) should be used to terminate tests if an unsafe level is detected in the ear canal

3.test levels should be limited to 70 dB SPL except when necessary to verify the limiting levels of the hearing aid, in which case, the test should not last longer than 15 seconds

4.be aware of the test signal and patient reaction during a test and be prepared to respond to any sign of discomfort by reducing the SPL setting, switching off the equipment or the hearing aid, or removing the patient from the area.

When using the equipment to measure the Real-Ear to Coupler Difference in small ear canals, it is possible to induce a hearing loss if the test is allowed to continue for more than 1 hour. Since accurate results can be obtained in less than 10 seconds, this possibility should never occur in normal practice.

Power and Grounding:

This product contains numerous safety features to ensure that the probability of electrical shock is as low as reasonably practicable. In order to ensure that all of the safety features work optimally you must ensure that the power cord is plugged into a grounded outlet. Any line-powered peripherals connected to the Verifit must comply with UL/IEC 60601-1 OR comply with UL or IEC or ISO safety standards for such equipment, AND a) be operated from an isolating transformer complying with UL/IEC 60601-1, OR b) be kept at least 6 feet (1.8m) from the patient.

Ear Infection:

Probe tubes or RECD foam tips should not be re-used on another patient. There is a possibility of transferring an ear infection to the other patient. Probe tubes and RECD foam tips are for single-patient use only. Do not attempt to clean or re-use.

Ear Canal Discomfort:

An otoscopic examination should always be performed prior to inserting a probe tube into the ear canal to ensure that it is healthy and free of obstructions. Care is needed when inserting probe tubes into the ear canal. Although the probe tubes are made of soft, flexible material specially designed for this application, it is possible to scrape the ear canal or touch the eardrum causing brief discomfort. You should carefully follow the instructions in “Positioning the probe tube” section of this User’s Guide.

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Verifit®User's Guide Version 3.12 ã May 2015

2 Getting Started

This section provides instructions for unpacking the Verifit and connecting various components and associated items.

Unpacking and connecting

1.Carefully unpack the two parts of the Verifit and check the contents of the shipping box against the enclosed packing list. Note that some parts may be packed inside the test chamber.

2.Connect the two 15 pin cables from the connectors on the rear of the test chamber to the connectors on the front of the main display unit as shown. The top side of each connector is labeled to assist you. Take care not to force the connectors as the pins are easily bent. Both short (as shown) and long cables are provided for flexibility in locating the two parts of the instrument.

3.Connect the power cord to the socket next to the power switch on the left side of the main display unit. Plug the other end into a grounded 100 – 240 volt power outlet.

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Verifit®User's Guide Version 3.12 ã May 2015

Microphone connection

1.Plug the reference microphone and the coupler microphone into the connectors in the test chamber as shown.

2.Plug the probe microphone assemblies into the probe connectors located at the front edge of the built-in keypad as shown.

NOTE: A microphone extension cable (VA-131, VA133) is available from Audioscan. Standard audio extension cables should not be used. They will substantially increase noise levels.

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Verifit®User's Guide Version 3.12 ã May 2015

General care instructions

Probe tubes are for single patient use only. They may be wiped with alcohol wipes for re-use with the same patient, but must not be used with multiple patients. Attempts at ultrasonic cleaning usually result in cerumen becoming lodged in the lateral end which causes irreparable damage to the probe microphones.

The case can normally be cleaned/dusted with a damp cloth, however if it is soiled we recommend wiping with a mild solution of water and detergent, or with alcohol-impregnated wipes deemed safe for use on electronic equipment. Parts that come into contact with patients (the probe module body, cable, and blue lanyard) should be regularly wiped down with alcohol wipes.

Hearing instruments should be cleaned prior to introduction to the test chamber due to the difficulty of sanitizing the acoustic foam. Custom hearing instruments must be cleaned with disinfectant towlettes (i.e. audiowipes) prior to placing in the test for this reason and to minimize contamination of the blue putty used with the HA-1 coupler. The acoustic foam in the floor of the test chamber is easily removed and should be replaced if badly worn or soiled.

The foam floor in the Verifit test chamber is printed on both sides and may be flipped over to double its life.

Audioscan recommends periodic replacement of the blue putty used with the HA-1 coupler to ensure cleanliness. Both couplers and coupler mic can be wiped down with alcohol wipes as needed.

Ensure that all safety and usage recommendations on cleaning product packages are followed.

Microphone care

Coupler microphone:

1.DO NOT twist the cable when attaching a coupler to the coupler microphone. Turn only the coupler or unplug the coupler microphone before turning it.

2.DO NOT leave the coupler microphone plugged in when transporting.

3.DO make sure that the 2cc coupler is tightly screwed to the coupler microphone when performing hearing instrument tests. Coupler leakage can cause feedback and erratic response curves.

4.DO make sure the tubing on the BTE (HA-2) coupler is free from any cracks/tears.

5.DO make sure that any replacement tubing used on the BTE coupler is either obtained from Audioscan, or is #13 heavy wall earmold tubing exactly 10 mm in length.

Probe microphone:

Debris can alter the probe module reference microphone calibration and frequency response and can permanently clog the probe module port.

1.DO NOT reuse probe tubes. Probe tubes can be wiped with alcohol wipes for re-use with the same patient, but must not be used with multiple patients. Attempts at ultrasonic cleaning usually result in cerumen becoming lodged in the lateral end which causes irreparable damage to the probe microphones.

2.DO NOT attempt to open or repair the probe microphone. Attempting to repair the probe module may lead to damage or alteration of the factory calibration.

3.DO keep the probe module and probe tubes in a clean area.

4.DO stow the probe module when not in use or when transporting the Verifit.

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Battery pill use and care

The thin connecting strip of each battery pill is fragile. When inserting pills into hearing instrument battery compartments, take care that this strip is not pinched or bent severely as the battery door is closed.

1.Select a battery pill that is appropriately sized for the hearing instrument that you are testing.

2.Insert the pill into the hearing instrument, carefully closing the battery door over the thin connecting strip.

3.Plug the pill’s cable into the battery pill jack inside the Verifit test box (to the right of the coupler microphone connection).

4.Turn the hearing instrument on.

Mouse, keyboard, barcode scanner

The Verifit may be operated from the built-in keypad, a mouse or a standard computer (QWERTY) keyboard, which may also be used to enter headers and comments on printouts. A USB mouse or keyboard may be plugged directly into any of the USB ports provided. See Input device operation. Verifits with serial numbers below 4671 also have connectors for a PS2 mouse and keyboard.

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An optional barcode scanner may be connected to a USB port to enter threshold, UCL and RECD data directly from Audioscan printouts. Barcoded threshold data printed by some Grason-Stadler audiometric equipment may also be scanned. Scanners other than that supplied by Audioscan may not work and are not supported by Audioscan.

Monitor headphones

The monitor headphones supplied with the Verifit may be used to listen to the signal being measured by the coupler or the probe microphone. This is useful for:

1.listening to the hearing aid to troubleshoot sound quality complaints

2.listening to the wearer's own voice to troubleshoot occlusion effect complaints

3.verifying program settings and their notification beeps

4.demonstrating a variety of hearing aid features to parents, teachers and significant others

Plug the headphones into the jack marked "Headphones" on the right side of the test chamber, near the front. The volume may be adjusted using the volume wheel located next to the headphone jack. Rotating it toward the front of the test chamber increases the volume.

Failure to follow operating instructions could place the user or operator at risk.

External peripherals

Serial number 4671 and higher: An external video monitor (HDMI or DVI with adapter) may be connected to the HDMI connector on the rear of the main display unit. The internal display and external monitor will operate simultaneously. The external monitor must be capable of displaying 800 x 600 at a refresh rate of 60Hz. Ensure that the external display is powered up and set to the correct input prior to powering on the Verifit.

An external printer may be connected to one of the USB ports. It may be color or black & white but it must be PCL3, PCL 5 or Postscript compatible.

Serial number below 4671: Verifits with serial number below 4671 have 15 pin VGA monitor output which operates simultaneously with the internal display. An external printer may be connected to one of the USB ports or to the parallel port. It may be color or black & white but it must be PCL3, PCL 5 or Postscript compatible.

The external printer must first be selected in Setup. See Printing and Storing Results

Connectors for external front and back sound-field speakers are provided. The VA-111 external speaker with a multipurpose folding stand is available from Audioscan but any small, non-powered 4 - 8 ohm speaker having a smooth frequency response and good efficiency may be used. The rear external speaker is automatically selected when required by a test but the front speaker must first be selected in Setup. See External sound-field speaker setup

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Verifit connector panel – serial number 4671 and higher

Verifit connector panel – serial number below 4671. The RS232 Serial port and Aux Audio connectors are not active in this version of software.

WARNING: To avoid the risk of electrical shock, any line-powered peripheral equipment connected to this product must comply with UL/IEC 60601-1 OR comply with UL or IEC and ISO safety standards for such equipment AND a) be operated from an isolating transformer complying with UL/IEC 6061-1 OR b) be kept at least 6 feet (1.8 m) from the patient.

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3 General Operation

This section describes the use of the built-in keypad, a QWERTY keyboard (not included) or a computer mouse to control the Verifit and enter data. It also describes the use of an (optional) barcode scanner to enter data from printouts produced by Audioscan analyzers and provides instructions for updating the Verifit operating software.

Input device operation

The Verifit may be operated by means of the built-in keypad, an external mouse or an external QWERTY keyboard. These devices are used to summon on-screen menus and select items from them, to operate on-screen buttons and to input data. The scroll wheel on this type of mouse will scroll through long lists in list boxes and in Help. Clicking the right mouse button generates an image of the keypad which may be operated by the mouse. Clicking the left mouse button when the mouse pointer is on a graph will display a screen cursor with a digital readout of X and Y co-ordinates. Clicking again will dismiss the cursor. Note that mouse speed can be

changed by selecting Setup and Display.

 

 

 

 

Function

Keypad

QWERTY

Mouse

Summon Help menu

<Help>

F1

Right click

Summon Setup menu

<Setup>

F2

Right click

Summon Test menu

<Tests>

F3

Right click

Summon Session menu

<Session>

F4

Right click

Switch between Ears or

<Left/Right>

F5

Left click or Right click

A/B Data or Help index and Help page

 

 

for keypad image

Print

<Print>

Print Scrn

Right click

Move across screen columns

 

 

Move mouse

 

Arrows

Arrows

 

Move within a screen column

Arrows

Arrows

Move mouse

Select a highlighted item or operate a

Round key (<PICK>

Numeric

Left click

screen button

key)

Enter Key

 

Enter numeric data

Select point on chart

Numeric

Left click on a point on

 

 

keypad

chart

Enter text

Not possible

Any key

Not possible

Proceed from current state

<Continue>

Enter

Click Continue

Revert to previous state

<Cancel>

Esc

Click Cancel

Barcode data input

In Speechmap, Viewport and Insertion gain tests, audiometric data in barcode form on an Audioscan analyzer printout may be entered by scanning the appropriate barcode. In Speechmap, air and bone threshold, UCL, RECD, audiometric transducer, age, and ABR nHL to eHL conversion factors are encoded. In Insertion gain, threshold and audiometric transducer type are encoded. The type of data and the ear (left, right or left/right) is shown below the barcode. Only data for the displayed ear are imported (data for both ears in dual view). Barcodes may be scanned in any order and it does not matter if the barcode is 'upside down'.

1. Select Speechmap, Viewport or Insertion gain from the Tests menu.

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2.Hold the printout so that the barcode is flat. With the scanner 6 – 8 in. (15 – 20 cm) from the barcode, press the trigger on the scanner and center the illuminated red line along the length of the barcode.

3.When the scan is successful, the scanner will 'beep', the red line will extinguish and a Barcode Entry poster will appear on the screen. A green checkmark on the poster shows which data have been accepted. A message will advise if the barcode does not contain data for the screen you are viewing.

4.When all desired data have been accepted, select [Done] to apply the data.

See Barcodes, tabular data, headers and comments on printouts under Printing and Storing Results.

Keypad keys

 

 

Keypad Button

Function

<Help>

Summon context-sensitive Help Screen.

<Setup>

Summon Setup Menu containing a list of Verifit features that can be

 

modified. Any modifications made will be maintained after power off.

<Tests>

Summon Test Selection Menu containing a list of the available test

 

procedures.

<Session>

Summon Session Data Menu to erase, export or import data

<Left/Right>

Used in the Single View Mode to alternate between ears or A/B Data. Used

 

in the Dual View Mode to navigate between ears or test panels. Used in

 

Help to switch between Help index and Help page.

<Print>

Print on internal or external printer or print to file.

Arrows

Move across screen columns.

Arrows

Move within a screen column.

 

Round Key (<PICK> key)

Select a highlighted item or operate a screen button.

<Continue>

Proceed from current state.

<Cancel>

Revert to previous state.

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Menus, lists and buttons

Menu buttons Screen buttons

As illustrated above, menu buttons are gray rectangular bars containing descriptive text while screen buttons are a highlighted square at the right-hand end of a white window. A screen button with a down arrow indicates that it will summon a drop-down list of options, the current selection being shown in the window to its left. A plain button toggles between two choices; the current choice is shown in the window to its left.

Positioning the mouse cursor over a menu button changes it from gray to white; positioning it over a window with a screen button changes the button from dark gray to light gray. Left clicking the mouse operates the selected button. A menu button or the window containing a screen button, selected using the keypad or a QWERTY keyboard is surrounded by a heavy line and is operated by pressing the <PICK> (round) key on the keypad or the Enter key on the numeric keypad on a QWERTY keyboard. This process also selects the highlighted item in a drop-down option list.

Screen messages and Help

The Title bar (top line of the display screen) informs you of the selected Test (e.g., Speechmap).

The Message bar (bottom line of the display screen) suggests the next step in a test or informs you of the state of the instrument or conditions that could affect your data. For example, it will inform you if the microphones need to be calibrated.

Context-sensitive help is available by pressing <Help> or F1 on a connected QWERTY keyboard. The Left/Right key or a mouse may be used to switch between the Help index (left panel) and the Help page (right panel). The side sliders on each panel may be used to scroll through the Help index or long Help pages. This

may also be accomplished using the

arrows, the scroll wheel on the mouse or the arrows on a QWERTY

keyboard.

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Software updating

If your Verifit does not have a CD drive (serial number 4671 and higher) a USB flash drive was shipped with your Verifit. It is required to transfer software updates from a PC to the Verifit. Please STORE IT IN A SAFE PLACE. You may download the latest software from www.audioscan.com or request that a CD-ROM be mailed to you. Instructions for transferring the software update from your PC to the Verifit will be included with the software download or the CD-ROM.

If your Verifit has a CD-ROM drive (serial number less than 4671), you may download the latest software from www.audioscan.com and burn it to a CD-ROM. Alternately, you may request that a CD-ROM be mailed to you.

To install the new CD-ROM:

1.Under Setup, select CD-ROM, then select Open CD drive.

2.Press the OPEN button on the door of the CD drive. The door should open.

3.Remove the old CD-ROM by pressing on the center spindle and gently lifting the outside edge.

4.Position the new CD-ROM on the spindle, printed side up, and press gently downward until it snaps into place.

5.Gently push the CD drive door inward until it snaps closed.

6.Select <Continue> and follow on-screen instructions.

If the CD drive door fails to open in step 2, switch the Verifit OFF and back ON and press the OPEN button on the CD door within 3 – 5 seconds. The door should open. Switch the Verifit OFF and install the new CD-ROM. Switch it ON and follow any on-screen instructions. If necessary to open the CD drive without power, insert the end of a small screwdriver (or paper clip) in the hole near the light on the CD drive door.

Note that the CD-ROM must be present in the CD drive for normal operation

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4 General Setup

This section covers Date and Time setup, Display settings (including mouse pointer speed setting) and Saving test setup.

Date and time setup

To set the date and time that appears on printouts and calibration screens:

1.Press <Setup>, then highlight and <PICK> [Date & Time] on the Setup poster.

2.To change the date, highlight and <PICK> the month window to display a drop-down list of months.

3.Highlight and <PICK> the desired month on the list.

4.Repeat the previous step to change the date, year and time in the appropriate windows.

5.When the new date and time information has been set, press <Continue> to exit.

Display settings

To change the screen language, screen saver timing and the background color for charts (for both the internal display and any connected external monitor):

1.Press <Setup>, then highlight and <PICK> [Display].

2.To change the screen language, highlight and <PICK> [Language] to toggle between English and German.

3.To change the idle time before the screen saver blanks the screen to prolong display life, highlight and <PICK> the Screen saver window.

4.Highlight and <PICK> the desired screen saver timing from the drop-down list.

5.To change the background color of the graphic display on the various test screens, highlight and <PICK> [Color] to toggle between black and white.

6.In this screen you can also select the Mouse pointer speed button and select the response speed from the drop-down list.

7.Press <Continue> to exit setup.

Saving test setup

This feature lets you retain the last-used stimulus type and level for most tests when the power is turned off and the last-used target method and transducer type in Viewport, Speechmap and Insertion Gain tests. This feature also lets you determine how assessment parameters, test levels and stimuli are treated when <Session>, [Erase data] is selected.

To enable/disable saving of test levels, stimuli and assessment parameters:

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1.Press <Setup>, then highlight and <PICK> [Save option]

2.Highlight and <PICK> [Save test setups on power off] to toggle between Yes and No.

To enable/disable erasing of test levels, stimuli and assessment parameters when Erase data is selected:

1.Press <Setup>, then highlight and <PICK> [Save option]

2.Highlight and <PICK> [Save test setups on erase data to toggle between Yes and No.

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5 Networking

Connection to a computer network allows screen images to be printed on a network printer or on a shared printer on a networked PC. Images and underlying data may also be saved to a shared folder on a networked PC. See Printing and Storing Results for details. The Verifit may also be connected to a single computer using a network router, switch or hub. Note that sharing data with NOAH is done over this network connection.

Failure to follow operating instructions could place the user or operator at risk.

Networking requirements

Connection of the Verifit to a computer network requires a Cat 5, RJ-45 cable.

The Verifit can connect to a local area network (LAN) using either automatic or static internet address assignment. Most home and small-office networks use automatic addressing. These networks have a DHCP server (Dynamic Host Configuration Protocol). Special-purpose networks might use static address assignment provided by the network administrator.

Networking setup

Check Networking requirements and connect the Verifit to your network.

1.Press <Setup> and then choose [Network] from the Setup menu.

2.In the Network poster, select [Enable].

3.In most cases, your network will support automatic address assignment (DHCP) and you need only select [Auto] and click on [Test ].

4.If the test is successful, your computer domain, address and port assignments will be reported.

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Note for network administrators: To manually change networking settings, uncheck Auto and click the Change button.

NOAH Service Port

Consult your Network Administrator before changing the NOAH service port. Changing the port successfully requires understanding the security polices on your Windows PC and computer network.

The Audioscan NOAH Module communicates with the Verifit through the NOAH network service. The Verifit provides the NOAH service on a TCP port. The Windows computer running the module must be configured to access the same TCP port, which is 8080 by default. Some Windows anti-virus software packages and some network firewalls prevent access to specific ports, including 8080. Using the NOAH module in the presence of such security settings may necessitate changing the NOAH service port.

Note that changing the NOAH service port requres restarting the Product software.

Changing the NOAH service port

1.Press <Change> next to the NOAH service port.

2.Select the appropriate five digits to enter the desired port number. The software will prevent you from entering the same port as the Product web service (typically port 80).

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3.Select <Continue>.

4.You will be prompted to restart the equipment. Select <Continue> to restart, or <Cancel> to enter a different port number.

Testing the NOAH service port

The Verifit provides the NOAH service using the HTTP protocol. Communication between the Windows PC and the Verifit can be tested using an ordinary web browser.

1.On the Windows PC, enter the Verifit network address and port number into a web browser following this example:

http://172.30.86:8080/noah

2. If the communication is successful, the web browser will display NOAH data formatted in XML: <noah> Example XML </noah>

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6 Single computer connection

Most office computers today are already connected to a network, through either a wired or wireless (wifi) interface. In these cases, the Verifit must be added to the same network as the computer. (See Networking for details.) In cases where no network exists, the Verifit can be networked directly to a single computer. There are two methods, depending on the network hardware available. The following two sections describe the alternatives. The computer must be running Windows 7 or higher and have an available, functioning network port.

Please note: only use these methods of connection if your PC is not currently on any network (i.e. the computer does not print to a network printer, does not receive email, and does not have Internet access). Adding a second network connection to a Windows PC is complex and can have unexpected effects on the primary connection.

Automatic connection (recommended)

Automatic connection requires a small 10/100 network router. Most routers have DHCP address assignment active by default and do not require changes from the default Windows settings on the computer to establish a simple connection with a Verifit.

3.Connect a Cat 5, RJ-45 cable from one router port to the Verifit network connector.

4.Connect a second cable from a router port to the network connector on the PC.

5.On the Verifit, press <Setup> and then choose [Network] from the Setup menu.

6.Select [Enable]. Ensure the Auto checkbox is checked, and choose [Test].

A network address will be provided by the router and should show up in the 'Network address' window.

By default, Windows 7 computers have networking and DHCP enabled so at this point your connection should be complete.

If required, to check your PC settings:

1.Go to Control Panel / Network and Sharing Center then select 'Change Adapter Settings' on the left-hand panel.

2.Right-click on Local Area Connection and choose Properties. Ensure that Internet Protocol (TCP/IP or TCP/IPv4) is checked. Select this and select the Properties button. Ensure that 'Obtain an IP address automatically' is selected.

Static connection

A static connection requires an Ethernet switch. The Network addresses must be entered manually into the Verifit and into the computer's Windows network setup.

1.Connect a Cat 5, RJ-45 cable from one port on the Ethernet switch to the Verifit network connector.

2.Connect a second cable from another port on the Ethernet switch to the computer's network connector.

3.In Windows 7, go to Control Panel / Network and Sharing Center then select 'Change Adapter Settings' on the left-hand panel.

4.Right-click on Local Area Connection and choose Properties. Ensure that Internet Protocol (TCP/IP or TCP/IPv4) is checked. Select this and select the Properties button.

5.Check 'Use the following IP address' and enter the following in the IP address box: 172.30.1.1. Enter

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255.255.255.0 in the Subnet mask box.

6.On the Verifit, un-check Auto (use DHCP) on the Setup network screen and click the Change button. Then set the network addresses as shown below by clicking on the down arrow buttons and selecting from the drop-down lists.

7.On the Verifit, uncheck Auto on the Setup network screen and click the Change button. Then set as shown below by clicking on the down arrow buttons and selecting from the drop-down lists.

8.Select [Continue].

9.Click on the Test button to check that a connection has been established.

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