Interacoustics Sera

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D-0112389-I – 2022/04

Sera™ - Instructions for Use - EN Page 8

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Table of Contents3
Introduction7
About this Manual7
Intended Use7
Contraindications7
Product Description8
Clinical Benefit9
Warnings10
Malfunction10
Safety Precautions11
General11
Cautions - General11
Environmental Factors12
Electrical and Electrostatic Safety12
Electromagnetic Compatibility (EMC)12
Explosion Hazards12
Use in Home Healthcare Environment13
Measuring Security and Clinical Benefit13
Miscellaneous13
Use of Equipment after Transport and Storage13
Unpacking and Installation15
Unpacking and Inspection15
Markings16
Installing the Cradle17
Installing the HM-E200 Label Printer (Optional)18
Battery Charging19
Installing Label Paper in the Printer19
Turning the Printer on and off19
Connecting the Wireless Printer to the Sera19
Printer Offline20
The Sera TM Hardware21
Connecting the Probe Cable to the Sera TM22
Connecting Transducers to the Preamplifier22
Connecting the Electrode Cables to the Preamplifier22
Use of the IP30 Transducer with Ear Tips or Earcups (ABRIS Only)23
Connecting to the Optional Pass-Checker23
Transducers and Calibration24
Charging and Powering Sera25
The Battery25
Battery Lifetime and Charging Time25
Indication Lights on Sera26
Hearsim TM Software Bundle27
Licenses27
Adding a New License to Sera TM27
Updating the Firmware27
Operating Instructions29
General Precautions29
Switching the Sera TM on and off30
Testing During Charging30
Battery Charge Status Indicator30
Sera TM Operation and Button Overview31
The Sera TM Screen F Ormat31
Common Function Buttons32
Keyboards (Special Characters)32
Home Screen34
Adding a New Patient34
Patient ID Conflict35
Selecting from the Patient List36
General Test Information37
Patient Preparation - Automated ABR Testing37
Patient Preparation - OAE Testing37
Handling and Selection of Ear Tips37
Use of Earcups38
Starting a Test38
Select Test Type39
Test-Related Field Entry39
Stop Reason for Incomplete Test40
Printing after Testing41
Automated ABR Testing42
Automated ABR Initial Test Screen42
Impedance Check Screen43
Automated ABR Measurement Screen44
Noise Bar44
Time Bar45
Test Done Screen45
OAE Testing47
OAE Initial Test Screen47
Probe Check Screen48
OAE Measurement Screen50
Probe Stability Bar51
Noise Bar51
Time Bar52
Test Done Screen52
Probe Stability % (DPOAE Only)55
Stimulus Stability % (TEOAE Only)55
Artifact55
Time55
Quick Test56
General56
Saving a Quick Test56
Printing57
Ways of Printing57
Label Print Format57
Reviewing Patients and Saved Sessions58
Select Patient58
Search for a Patient58
Test Button58
View Saved Tests58
Printing a Saved Test59
Reviewing a Saved Test59
User Management on Device60
General60
Selecting the User (Optional)60
Entering the Password60
Incorrect Password61
Setup62
Language Screen62
Device62
Sound63
Printer63
About64
Equipment (Integrity) Checks65
General65
Pass-Checker for Automated ABR (Optional)65
Probe Integrity Test for TEOAE67
Probe Integrity Test for DPOAE68
Maintenance69
General Maintenance Procedures69
Cleaning the Sera70
Touch Screen70
Case, Cradle and Cables70
Disposables70
Cleaning the OWA Probe Tip71
Cleaning the Snapprobe73
Accessories/Replacement Parts73
Repair74
Warranty74
General Technical Specification75
Sera Instrument - Technical Specif Ications75
Specification of Input/Output Connections79
Calibration Reference Values for the CE-Chirp® Stimulus80
Calibration Reference Values for the Click Stimulus80
Coupler Types Used for Calibration80
General Information about Specifications81
Appendix A: Stimulus81
Appendix B: Electromagnetic Compatibility (EMC)82

Interacoustics Sera - Page 14

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