audioscan verifit - Manufacturer Disclosure Statement for Medical Device Security; 25 Appendix 1

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Verifit

®

User's Guide Version 4.8 © November 2016

25 Appendix 1

Manufacturer Disclosure Statement for Medical Device Security

158

Table of Contents

Default Chapter2
- Table of Contents2
1 About Verifit6
- Product Description6
- Accessories12
- Associated Items and Supplies12
- SAFETY WARNINGS and NOTICES13
- Environmental Safety14
- Declaration of Electromagnetic Compatibility (EMC)14
- Warranty, Trademarks, Acknowledgments15
- EC Declaration of Conformity17
- Electronic User's Guide18
- How to Avoid Undesirable Side Effects18
2 Getting Started20
- Office Setups20
- Unpacking and Connecting20
- Microphone Connection22
- General Care Instructions24
- Microphone Care24
- Mouse and Keyboard25
- Monitor Headphones25
- External Peripherals27
3 General Operation28
- Switching ON/OFF28
- Input Device Operation28
- Network Connection30
- Printer Connection31
- Menus, Lists and Buttons32
- Screen Messages and Help32
- Software Updating32
4 General Setup34
- Date and Time Setup34
- Display Settings34
- Saving Test Setup34
5 On-Ear Measures - Setup36
- External Sound Field Speaker Setup36
- On-Ear Calibration Facts37
- Calibration of On-Ear Probe Microphone37
- Calibration Check for Probe Module39
- Max TM SPL Setup40
- ABR Nhl to Ehl Setup40
- Positioning the Client40
- Positioning the Probe Tube41
6 On-Ear Measures Screen Setup43
- On-Ear Single or Dual View43
- Graph, Table or 2Cc Target Format43
- SPL or HL Scale43
- Hide or Show On-Ear Curves43
7 Speechmap45
- Speechmap Facts45
- DSL 5 in Speechmap45
- NAL-NL1 in Speechmap46
- NAL-NL2 in Speechmap46
- Camfit in Speechmap46
- Using Speechmap47
- Speechmap Setup47
- Screen Tour - Unaided Screen49
- Screen Tour - Aided Screen50
- On-Ear or Test Box Mode50
- SII Calculation in Speechmap51
- Using Custom Stimuli in Speechmap51
- Creating WAV Files for Speechmap53
8 Speechmap Fitting Procedures55
- Speechmap Screen Choices55
- Data Entry57
- Fitting to Targets for Soft Speech57
- Fitting to Targets for Average Speech58
- Adjusting the Maximum Output Level59
- Open Fittings in Speechmap60
- Verifying Frequency Compression/ Frequency-Lowering Hearing Instruments in Speechmap61
- Binaural Fitting in Speechmap62
- CROS Fitting in Speechmap63
- T-Loop Fitting and Verification in Speechmap64
- Tele-Test Fitting and Verification in Speechmap65
- FM Fitting and Verification67
- How to Verify with Calibrated 'S' and 'SH' Stimuli67
9 Speechmap Technical Details69
- Wideband Measurements in Speechmap69
- Speechmap Stimuli69
- Stimulus Spectra70
- Microphone Location Effects72
- Deep Insertion Compensation72
- Speech Signal Analysis73
10 On-Ear Instrument Measures74
- On-Ear Directional Test Overview74
- On-Ear Directional Testing74
- On-Ear Feedback Test75
- On-Ear Noise Reduction Test75
- On-Ear Noise Reduction Stimuli76
- On-Ear Manual Control76
- Sound Level Meter Using On-Ear Microphones77
11 WRECD Measurement78
- Calibration of WRECD Transducer78
- Measure WRECD79
- WRECD Results80
- WRECD Protocols81
- WRECD Facts82
12 Occlusion Effect Test83
- Occlusion Effect Measurement83
13 Sensory Loss Simulator84
- Sensory Loss Simulator Description84
- Sensory Loss Simulator Operation84
14 Insertion Gain86
- Insertion Gain in SPL86
- Insertion Gain in HL87
- Audiometric Data Entry88
- REUR Measurement Procedure89
- REAR Measurement Procedure90
- SII Calculation in Insertion Gain90
- CROS Fitting Using Insertion Gain91
- Verifit ® User's Guide Version 4.8 © November92
15 Test Box Measures - Setup93
- Test Box Screen93
- Format95
- Scale95
- Hide or Show Test Box Curves95
- ANSI Test Frequencies96
- Test Box Calibration Facts97
- Calibrating Test Box Reference Microphone97
- Calibration Check for Coupler Microphone98
- Coupling for Binaural/Wideband Tests99
- Positioning HI for Binaural/Wideband Tests99
- Coupling for ANSI/IEC Tests100
- Positioning HI for ANSI/IEC Tests101
16 ANSI/IEC Hearing Aid Tests103
- ANSI S3.22-2003 and ANSI S3.22-2009 Facts103
- ANSI 2003 and 2009/IEC Tests103
- ANSI Test Results104
- ANSI Input-Output Curves104
- ANSI Telecoil Terminology105
- ANSI Telephone Simulator (TMFS) Test105
- ANSI Test Loop Test106
- Telecoil Test Results107
17 Other Test Box Measures108
- Harmonic Distortion108
- Noise Reduction108
- Noise Reduction Stimuli109
- Directional Function Test109
- Directional ITE Positioning110
- Directional BTE Positioning110
- Test Box Directional Procedure111
- Multicurve Procedure112
- Multicurve Results112
- Spectral Analysis in Multicurve113
- Battery Drain Test113
- Manual Control Procedure114
- Sound Level Meter Using Manual Control115
18 Networking117
- Networking Standards117
- Network Setup117
- Remote Operation119
- Changing the Remote Operation Settings120
- Teleaudiology120
- Changing the Teleaudiology Settings120
- NOAH Service Port121
- Changing the NOAH Service Port121
- Testing the NOAH Service Port122
- Web Service Port122
19 Single Computer Connection124
- Automatic Connection (Recommended)124
- Static Connection124
20 Printing and Storing Results126
- Storing Data in NOAH126
- Printing Results126
- Printing Setup126
- Printer Connection127
- Verifit ® User's Guide Version 4.8 © November127
- Printer Types128
- HP Printer128
- Custom Printer128
- File Output129
- Page Setup129
- Windows-Shared Printers and Folders131
- Network Printer133
- Web Browser Screen Capture133
- Session Setup134
- Storing and Restoring Session Files135
21 Troubleshooting137
- Self Test Failures137
- Initialize Function137
- Inconsistent Levels in Speech Stimulus138
- Test Box High Distortion or Noise138
- Test Box Curves Inconsistent138
- Test Box Curves Differ from Specifications138
- Test Box Speaker Overdriven139
- No Test Box Reference MIC. Detected139
- Invalid Test Box Calibration139
- Unable to Calibrate Test Box Microphone139
- No On-Ear Ref. MIC. Detected140
- Invalid On-Ear Calibration140
- Unable to Calibrate On-Ear Microphone140
- Sound Field Speaker Overdriven140
- Binaural Tests Run Twice141
- Invalid Binaural Equalization141
- Invalid WRECD Transducer Coupler Calibration141
- Invalid RECD Real Ear Measurement141
- Headphone High Distortion or Noise142
22 Technical Specifications143
23 Glossary150
24 References155
- Manufacturer Disclosure Statement for Medical Device Security158
25 Appendix 1158

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