GSi CORTITM - Regulatory Symbols

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Regulatory Symbols

No.

Symbol

IEC Pub.

Description

980 & 60601-1

Serial Number

980 & 60601-1

Date of Manufacture

980 & 60601-1

Manufacturer

980 & 60601-1

Caution, Consult Accompanying

Documents

980 & 60601-1

Return to Authorized Representative,

Special Disposal Required

980 & 60601-1

Reference Number

60601-1

B Patient Applied Part According to

IEC60601-1

980 & 60601-1

Consult Operating Instructions

60601-1

Keep Dry

60601-1

Transport and Storage Temperature

range

Logo

EC REP

980 & 60601-1

EU Authorized Representative

ISO 7010-

M002&60601-

Where Appropriate

REF

Main Page

Default Chapter1
- User Manual1
- Table of Contents3
Standards Compliance7
Indications for Use8
Warranty9
Warnings, Cautions, and Errors10
- Status/Error Messages12
Customer Responsibility14
Safety Precautions15
- Cautions - General15
- Warning - Electric Shock Hazards16
- Warning - in Case of Emergency16
- Warning - Explosion16
- Warning - Battery Safety16
- Warning - General16
Recycling/Disposal17
Regulatory Symbols18
Introduction20
- How Does the Corti Device Work20
- What Are Dpoaes20
- What Are Teoaes21
- What Do Otoacoustic Emission Results Tell Us21
- What Frequency Range of Hearing Is Estimated21
- How Are the Results Stored and Reported21
- Sensitivity and Specificity22
Setup23
- Unpacking the System23
- Optional Accessories23
- Cradle (Optional)23
- Battery Charging23
- Installing the Probe24
- Attaching Probe Tube25
- Attaching Eartips25
Operating Instructions27
- Preparing the Patient for Testing27
- Turning on the Instrument27
- Control Panel27
- Main Menu28
- Selecting the Test Protocol28
- Starting a Test28
- Autostart Probe Check29
- Test Phase29
- SNR Bar Graph View30
- Value Graph View30
- Viewing Results30
- Test Technique31
- Noise Sources32
- Turning off the Instrument32
Managing Results33
- Saving Results33
- Deleting Results34
- Printing to a Thermal Printer34
- Connecting to the Corti Data Manager35
Understanding Printed Results36
- Understanding the DPOAE Printout36
- Understanding the TEOAE Printout36
- Rounding Results37
Clock Settings38
- Accessing the Clock Menu38
- Changing the Date/Time38
Instrument Settings39
- Wireless Device Pairing39
- Clearing Test Results40
- Auto Shutdown Time40
- Save Mode/Storing Test Results40
- Minimum Amplitude41
- Clock Mode41
- Graph Style41
- Language42
- Reset to Default42
Advanced Options for the DPOAE Diagnostic Unit43
- Instructions for Customizing a Test Protocol43
- Selecting the Level of Primary Tones44
- Setting the Averaging Time44
- Setting the PASS SNR Level44
- Setting the Number of Frequencies for PASS45
- Reset Protocol45
- Save Protocol45
Advanced Options for the TEOAE Diagnostic Unit46
- Instructions for Customizing a Test Protocol46
- Selecting the Averaging Time47
- Setting the PASS SNR Level47
- Setting the Number of Frequencies for PASS47
- Reset Protocol48
- Save Protocol48
Cleaning and Maintenance49
- Cleaning and Disinfection49
- Maintenance50
- Probe Tube Replacement50
Troubleshooting51
Appendix A: Specifications53
Appendix B: Flowcharts54
- Flowchart - Measurement54
- Flowchart - Setup Menus55
Appendix C: Test Sequence56
- For Dpoae56
- For Teoae56
- Comment about Variations in the SNR Estimate57
Appendix D: Pass/Refer Criteria58
- Pass/Refer Criteria for DPOAE58
- Pass/Refer Criteria for TEOAE59
Appendix E: Configurations and Test Protocols60
Appendix F: EMC Compatibility62
- Electromagnetic Compatibility62
- Electrical Safety, EMC and Associated Standards62
- Guidance and Manufacturer's Declaration - Electromagnetic Emissions63
  - Guidance and Manufacturer's Declaration - Electromagnetic Immunity64
  - Guidance and Manufacturer's Declaration - Electromagnetic Immunity65

GSi CORTITM - Regulatory Symbols

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