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Interacoustics Sera User Manual

Interacoustics Sera
87 pages
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Instructions for Use - EN
Sera™
Science made smarter
8501165 / D-0112389-I 2022/04

Table of Contents

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Interacoustics Sera Specifications

General IconGeneral
BrandInteracoustics
ModelSera
CategoryMedical Equipment
LanguageEnglish

Summary

Introduction

About this manual

Manual validity, manufacturer details, and contact information for the SeraTM device.

Intended use

Specifies the audiologic applications and target population for the SeraTM device.

Contraindications

Lists conditions where testing is not advised without medical approval.

Product description

Details the SeraTM device's capabilities, configurations, and components.

Clinical benefit

Explains the importance of diagnosing hearing loss in infants for development.

Warnings

Defines symbols used for warnings, cautions, and notices in the manual.

Malfunction

Provides instructions for handling and reporting product malfunctions.

Safety Precautions

General

General safety guidelines for operating electrical equipment and device use.

Cautions - general

Important cautions regarding device operation, repair, and accessory use.

Environmental factors

Specifies recommended operating and storage conditions for the instrument.

Electrical and electrostatic safety

Safety measures related to electrical connections and avoiding leakage current.

Electromagnetic compatibility (EMC)

Precautions for avoiding electromagnetic field exposure and mutual disturbance.

Explosion hazards

Warnings about using the device in environments with flammable gases or oxygen.

Use in home healthcare environment

Notes on the instrument's suitability for home healthcare use with protection.

Measuring security and clinical benefit

Emphasizes annual calibration for accuracy and potential warranty voiding.

Miscellaneous

Important notes on software installation, storage, handling, and disposal.

Use of equipment after transport and storage

Guidance on acclimatizing and checking the instrument after transport.

Unpacking and Installation

Unpacking and inspection

Procedures for checking the received instrument for damage and reporting faults.

Markings

Explains various symbols and their meanings found on the instrument.

Installing the cradle

Instructions on how to connect and place the SeraTM cradle for charging.

Installing the HM-E200 label printer (optional)

Guidance on connecting and pairing the optional wireless label printer.

Battery charging

Details on how to charge the printer's battery using various connection methods.

Installing label paper in the printer

Step-by-step instructions for loading label rolls into the printer.

Turning the printer on and off

How to power the printer on, off, and manage standby mode.

Connecting the wireless printer to the Sera™™

Instructions for pairing the HM-E200 printer with the SeraTM device.

Printer offline

Explains the error message when the printer is not found or out of range.

The Sera™™ hardware

Identifies and describes the main hardware components of the SeraTM handheld unit.

Connecting the probe cable to the Sera™™

Details the two methods for connecting the SnapPROBETM probe to the device.

Connecting transducers to the preamplifier

Instructions for connecting transducers via the preamplifier cable.

Connecting the electrode cables to the preamplifier

How to securely connect electrode lead cables to the preamplifier.

Use of the IP30 transducer with ear tips or EarCups (ABRIS only)

Describes the two versions of IP30 transducers for ABRIS module use.

Connecting to the optional pass-checker

Instructions on connecting the ABRIS pass-checker for hardware integrity assessment.

Transducers and calibration

Explains how SeraTM automatically detects transducers and reads calibration data.

Charging and powering Sera™™

Details on powering the instrument using the battery and AC cradle.

The battery

Information on the rechargeable Lithium-ion battery and connection for charging.

Battery lifetime and charging time

Precautions for battery maintenance and estimates of charging times.

Indication lights on Sera™™

Explains the meaning of LED indicator light colors on the SeraTM and cradle.

HearSIM™™ software bundle

Overview of the HearSIMTM software for device customization and data management.

Licenses

Information on managing test type licenses for the SeraTM device.

Adding a new license to Sera™™

Step-by-step guide to adding new test type licenses via software.

Updating the firmware

Instructions on how to check and update the device's firmware.

Operating Instructions

General precautions

Essential precautions for using the SeraTM device safely and effectively.

Switching the Sera™ on and off

Procedures for powering the SeraTM device on, off, and boot-up sequence.

Testing during charging

Guidelines on performing tests while the device is charging.

Battery charge status indicator

Explains how to interpret the battery status symbols and warnings.

Sera™™ operation and button overview

Overview of the SeraTM screen layout and common function buttons.

The Sera™ screen format

Details the components of the general SeraTM screen layout.

Common function buttons

Explains the icons and functions of common buttons used in the interface.

Keyboards (special characters)

How to access and use special characters on the on-screen keyboard.

Home screen

Describes the main screen and its buttons for accessing core functions.

Adding a new patient

Steps for entering patient demographic information manually.

Patient ID conflict

Explains the process for resolving duplicate patient ID entries.

Selecting from the patient list

How to find and select patients from the stored database.

General test information

Guidance on patient consent, test procedures, and result interpretation.

Patient preparation – Automated ABR testing

Steps for preparing a patient for Automated ABR testing.

Patient preparation – OAE testing

Guidance on preparing a patient for OAE testing.

Handling and selection of ear tips

Instructions on using and selecting appropriate disposable ear tips.

Use of EarCups and EARturtle™™

Guidance on using EarCups and EARturtle™™ accessories for testing.

Starting a test

Describes the different ways to initiate a test on the device.

Select test type

How to choose the specific test protocol (TEOAE, DPOAE, ABR) to perform.

Test-related field entry

Configuring and entering patient-specific test fields.

Screening result symbols

Explains the symbols used to indicate test results (Pass, Refer, Incomplete).

Stop reason for incomplete test

How to select and record a reason for an incomplete test.

Printing after testing

Procedures for printing test results using the label printer.

Automated ABR testing

Overview of the steps and screens involved in Automated ABR testing.

Automated ABR initial test screen

Details the initial screen and components for Automated ABR testing.

Impedance check screen

Explains the impedance check process and feedback indicators.

Automated ABR measurement screen

Describes the measurement screen, progress bars, and noise indicators.

Noise bar

How the noise bar indicates EEG quality and acceptable signal levels.

Time bar

Explains the progress of the time bar during the measurement.

Test done screen

Details the screen shown after completing an Automated ABR test.

OAE testing

Overview of the steps and screens involved in OAE testing.

OAE initial test screen

Details the initial screen and components for OAE testing.

Probe check screen

Explains the probe fit check process for DPOAE and TEOAE.

OAE measurement screen

Describes the OAE measurement screen with progress bars and stability indicators.

Probe stability bar

How the probe stability bar indicates fit quality during OAE testing.

Noise bar

How the noise bar indicates acoustic noise levels during OAE testing.

Time bar

Explains the progress of the time bar during OAE measurements.

Test done screen

Details the screen shown after completing an OAE test.

Quick test

Instructions for performing and saving quick tests without patient data entry.

General

Overview of the Quick Test function and its limitations.

Saving a quick test

Steps to save a Quick Test session to a specific patient.

Printing

Information on how to print test results from the device.

Ways of printing

Describes how to access printing functions from different screens.

Label print format

Details the information included on the printed labels.

Reviewing patients and saved sessions

Steps for managing patient data, viewing test history, and printing sessions.

Select patient

How to view and sort the list of patients stored on the device.

Search for a patient

Instructions on using the search function to find patients.

Test button

How to proceed with testing a selected patient.

View saved tests

How to access a list of previously performed tests for a patient.

Printing a saved test

Steps to select and print individual saved tests.

Reviewing a saved test

How to view detailed test results and associated field information.

User management on device

Information on setting up and managing user logins for the SeraTM device.

General

Overview of user login functionality, which is disabled by default.

Selecting the user (optional)

Steps for selecting a user from the list after login is enabled.

Entering the password

How to enter the user password to access the device.

Incorrect password

Explains the message displayed for incorrect password entries.

Setup

Accessing and configuring device settings directly on the SeraTM.

Language screen

How to select the preferred language for the device interface.

Device

Setting preferences for power save, power off, display brightness, and time/date.

Sound

Configuring sound feedback for button presses, test end, and warnings.

Printer

Steps for pairing the HM-E200 wireless printer with the SeraTM.

About

Viewing device information such as version, serial numbers, and licenses.

Equipment (integrity) checks

General

Recommends daily equipment checks to ensure proper functioning of probes and cables.

Pass-checker for automated ABR (optional)

How to use the optional Pass-Checker accessory for ABR integrity checks.

Probe integrity test for TEOAE

Procedure for testing probe integrity for TEOAE using the Infant Ear Simulator.

Probe integrity test for DPOAE

Procedure for testing probe integrity for DPOAE using the Infant Ear Simulator.

Maintenance

General maintenance procedures

Recommendations for maintaining instrument performance and safety, including annual service.

General maintenance procedures

Safety precautions and recommended solutions for cleaning the instrument.

Cleaning the Sera™™

Instructions for cleaning the touch screen, case, cradle, and cables.

Touch screen

How to clean the SeraTM touch screen using a lint-free cloth.

Case, cradle and cables

Guidance on cleaning and disinfecting the instrument's external parts.

Disposables

Emphasizes single-use nature of disposables and risk of cross-contamination.

Cleaning the OWA probe tip

Illustrated instructions for cleaning the OWA probe tip using cleaning floss.

Cleaning the SnapPROBETM

How to access and clean the filters within the SnapPROBETM probe.

Accessories/replacement parts

Recommends keeping reusable components and replacement parts available.

Repair

Conditions under which Interacoustics is responsible for repair and service.

Warranty

Details the warranty terms and expected service life of the SeraTM instrument.

General technical specification

Sera™ instrument – technical specifications

Comprehensive technical specifications including CE marking, standards, power, and environment.

Specification of input/output connections

Details pin descriptions for connectors and USB specifications.

Calibration reference values for the CE-Chirp® stimulus

Provides reference SPL values for CE-Chirp stimulus calibration.

Calibration reference values for the click stimulus

Provides reference SPL values for click stimulus calibration.

Coupler types used for calibration

Specifies the ear simulator coupler types used for calibration.

General information about specifications

Notes on product improvement, maintenance, and contact information for inquiries.

Appendix A: Stimulus

Explains the CE-Chirp® stimulus used in some ABR protocols.

Appendix B: Electromagnetic Compatibility (EMC)

Details EMC requirements and guidance for the SeraTM equipment.

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