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GSi CORTITM User Manual
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No.
Symbol
IEC Pub.
Description
CAN/CSA-
C22.2 No.
60601-1 (2008)
(Medical
Electrical
Equipment -
Part 1: General
Requirements
for Basic Safety
and Essential
Performance).
Only those produ
cts bearin
g the UL
Classification M
ark for the
U.S. and
Canada should be
considered as b
eing
covered by UL'
s Classification an
d
Follow-Up Serv
ice and m
eeting the
appropriate U.S. and C
anadian
requirements.
980 & 60601-1
Conforms to European Medical
Device Directive 93/94/EEC
FCC part 15
FCC 47CFR, Part
15.247 & 15.249
(Wireless)
18
20
Table of Contents
Default Chapter
1
User Manual
1
Table of Contents
3
Standards Compliance
7
Indications for Use
8
Warranty
9
Warnings, Cautions, and Errors
10
Status/Error Messages
12
Customer Responsibility
14
Safety Precautions
15
Cautions - General
15
Warning - Electric Shock Hazards
16
Warning - in Case of Emergency
16
Warning - Explosion
16
Warning - Battery Safety
16
Warning - General
16
Recycling/Disposal
17
Regulatory Symbols
18
Introduction
20
How Does the Corti Device Work
20
What Are Dpoaes
20
What Are Teoaes
21
What Do Otoacoustic Emission Results Tell Us
21
What Frequency Range of Hearing Is Estimated
21
How Are the Results Stored and Reported
21
Sensitivity and Specificity
22
Setup
23
Unpacking the System
23
Optional Accessories
23
Cradle (Optional)
23
Battery Charging
23
Installing the Probe
24
Attaching Probe Tube
25
Attaching Eartips
25
Operating Instructions
27
Preparing the Patient for Testing
27
Turning on the Instrument
27
Control Panel
27
Main Menu
28
Selecting the Test Protocol
28
Starting a Test
28
Autostart Probe Check
29
Test Phase
29
SNR Bar Graph View
30
Value Graph View
30
Viewing Results
30
Test Technique
31
Noise Sources
32
Turning off the Instrument
32
Managing Results
33
Saving Results
33
Deleting Results
34
Printing to a Thermal Printer
34
Connecting to the Corti Data Manager
35
Understanding Printed Results
36
Understanding the DPOAE Printout
36
Understanding the TEOAE Printout
36
Rounding Results
37
Clock Settings
38
Accessing the Clock Menu
38
Changing the Date/Time
38
Instrument Settings
39
Wireless Device Pairing
39
Clearing Test Results
40
Auto Shutdown Time
40
Save Mode/Storing Test Results
40
Minimum Amplitude
41
Clock Mode
41
Graph Style
41
Language
42
Reset to Default
42
Advanced Options for the DPOAE Diagnostic Unit
43
Instructions for Customizing a Test Protocol
43
Selecting the Level of Primary Tones
44
Setting the Averaging Time
44
Setting the PASS SNR Level
44
Setting the Number of Frequencies for PASS
45
Reset Protocol
45
Save Protocol
45
Advanced Options for the TEOAE Diagnostic Unit
46
Instructions for Customizing a Test Protocol
46
Selecting the Averaging Time
47
Setting the PASS SNR Level
47
Setting the Number of Frequencies for PASS
47
Reset Protocol
48
Save Protocol
48
Cleaning and Maintenance
49
Cleaning and Disinfection
49
Maintenance
50
Probe Tube Replacement
50
Troubleshooting
51
Appendix A: Specifications
53
Appendix B: Flowcharts
54
Flowchart - Measurement
54
Flowchart - Setup Menus
55
Appendix C: Test Sequence
56
For Dpoae
56
For Teoae
56
Comment about Variations in the SNR Estimate
57
Appendix D: Pass/Refer Criteria
58
Pass/Refer Criteria for DPOAE
58
Pass/Refer Criteria for TEOAE
59
Appendix E: Configurations and Test Protocols
60
Appendix F: EMC Compatibility
62
Electromagnetic Compatibility
62
Electrical Safety, EMC and Associated Standards
62
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
63
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
64
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
65
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GSi CORTITM Specifications
General
Brand
GSi
Model
CORTITM
Category
Medical Equipment
Language
English
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