Summary of Contents for Électronique du Mazet AudioBlue
- Page 1 Page 1 on 32 31/05/2021 ECH003XN101-A5 User Guide Audiometry equipment ECHODIA AudioBlue (AudioBlue, AudioLite)
- Page 2 Page 2 on 32 31/05/2021 ECH003XN101-A5 Instructions for use & Technical description Please read these instructions carefully before using your new device! This manual is an integral part of the device and must be kept until it is destroyed. This equipment has been designed and manufactured for use in otologic diagnosis.
-
Page 3: Presentation Of The Devices
ECH003XN101-A5 Presentation of the devices Our AudioBlue audiometry equipment line is designed for the screening, documentation, monitoring and diagnosis of hearing function. It is intended for use by ear, nose and throat specialists, neurologists, audiologists, pediatricians and other healthcare professionals in office and hospital settings. -
Page 4: Table Of Contents
6.2.1 Minimum system requirements....................15 6.2.2 Installation of the software ...................... 15 6.2.3 Patient management ........................ 17 6.2.4 Setting up the AudioBlue ......................18 CA Audiometry ....................20 6.3.1 Patient Preparation & Setup ..................... 20 6.3.2 Carrying out the measurement ....................20 Clinical Guide ...................... -
Page 5: Description And Technical Information
Page 5 on 32 31/05/2021 ECH003XN101-A5 Description and technical information This user and maintenance manual is published to help you to get started with your ECHODIA device from the initial receipt, through commissioning, use and maintenance. If you have any difficulty in understanding this manual, contact your dealer/distributor or the manufacturer, Électronique du Mazet. - Page 6 Page 6 on 32 31/05/2021 ECH003XN101-A5 Serial number Manufacturer Non-ionising electromagnetic radiation Product reference CE marking Medical device Buttons at bottom right earpiece shell Caution: Switching the device on/off USB-C port for charging the device Caution: For use only with the SWM6-5-EH-I38 adapter supplied with the unit...
-
Page 7: Technical Specifications
Page 7 on 32 31/05/2021 ECH003XN101-A5 Left earpiece shell (differs depending on the device) Commercial label 2.2 Technical specifications 2.2.1 General characteristics • Operating temperature: 15°C to 30°C. • Storage temperature: -20°C to 60°C. • Operating relative humidity: 30% to 90%. •... -
Page 8: Accessories
Page 8 on 32 31/05/2021 ECH003XN101-A5 2.2.4 Accessories This device is delivered with the following accessories as standard: • USB type C charging cable • USB power adapter The device is in contact with the patient through disposable covers that must be placed on each side of the helmet. -
Page 9: Nameplate Label
2.3 Nameplate label The information and characteristics are shown on the label on the right side of the headset. A second label is used to identify the product: Name of the device Device traceability label : (product code): AudioBlue ECH003KP100 AudioLite ECH003KP110... -
Page 10: Warnings
Page 10 on 32 31/05/2021 ECH003XN101-A5 Warnings CAUTION: The device must be handled by a qualified operator (hospital staff, doctor, etc.). The patient must not come into contact with the device other than through the accessories. CAUTION: The battery must be charged using the mains charger supplied. -
Page 11: Precautions
Page 11 on 32 31/05/2021 ECH003XN101-A5 CAUTION: The device has no special protection against flammable or corrosive products. Exposure to such products may damage the unit. Precautions Applied parts that are too old or of poor-quality can impair the quality of contact with the patient and cause discomfort. -
Page 12: Installation Of The Device
Page 12 on 32 31/05/2021 ECH003XN101-A5 Installation of the device Please refer to the instructions for the kit (device + accessory) for which the distributor is responsible. If you have any doubts about the integrity of the device and its proper functioning, contact Électronique du Mazet or your distributor. -
Page 13: User's Manual
On the computer, a new Bluetooth device must be added, When the window for adding a new Bluetooth device appears, it takes a few seconds before the AudioBlue and its serial number appear. -
Page 14: Switching Off The Device
Page 14 on 32 31/05/2021 ECH003XN101-A5 Just click on it to start the pairing. Finally, the power button must be pressed again so that the device exits pairing mode, the indicator light should then flash slowly in blue. This operation should only be carried out once when using the computer for the first time, or when changing computers. -
Page 15: Indicator Light
In this mode, it is also possible to pair a new answer button. • Steady blue: Bluetooth mode, the OtoWin software is connected to the AudioBlue. • Turquoise slow/fast/fixed flashing: Maintenance mode, used only by the manufacturer or distributor. - Page 16 Page 16 on 32 31/05/2021 ECH003XN101-A5 At the start of the installation, you must accept the user licence agreement. You can then choose to place an icon in the start menu and on the desktop. Finally, you can choose the location where the application files will be installed (by default "C:/Program Files/Echodia/OtoWin").
-
Page 17: Patient Management
Page 17 on 32 31/05/2021 ECH003XN101-A5 6.2.3 Patient management The OtoWin software allows measurements to be taken, stored and viewed. It integrates a database in which patient information and their respective measurements can be stored. 6.2.3.1 Add a patient to the database By default, the database does not contain patients,... -
Page 18: Setting Up The Audioblue
6.2.4 Setting up the AudioBlue By default, the AudioBlue device will not be detected by OtoWin. You have to activate its support in the software settings. To do this, click on the cogwheel at the top right of the homepage. - Page 19 Page 19 on 32 31/05/2021 ECH003XN101-A5 Click on "Enable AudioBlue" to allow the software to connect to the AudioBlue. By default, the detection is automatic. Each time the software starts, it will scan the various devices on your computer to find the AudioBlue.
-
Page 20: Ca Audiometry
- Place the audiometry headset on the patient's head. 6.3.2 Carrying out the measurement Start the OtoWin software, the window below will open. If the AudioBlue is correctly paired (Bluetooth) to your computer, and its support is activated in the software settings, the "Audiometry"... - Page 21 Page 21 on 32 31/05/2021 ECH003XN101-A5 There are three different modes for setting the acoustic stimulation characteristics: • Move the mouse cursor over the graphs, and click to start the stimulation. The Enter key is used to validate the patient response, •...
- Page 22 The automatic mode can be stopped by clicking this button again. 10. Saves the current measurement. 11. Allows a Weber test to be performed (not available with AudioBlue). 12. Summary of patient information. 13. Summary of information about the device used.
-
Page 23: Clinical Guide
No side effects identified to date Maintenance and servicing AudioBlue devices are designed to have a service life of 5 years. To ensure that the performance of the device is maintained throughout its life, it is necessary to have the device checked by Electronique du Mazet technicians or its authorised distributors every year. -
Page 24: Malfunction
Page 24 on 32 31/05/2021 ECH003XN101-A5 Malfunction If you notice a malfunction that is not documented on in the documents accompanying the device (see below), please inform your dealer or the manufacturer. In the case of a shipment of the device, please observe the following instructions: ▪... - Page 25 Page 25 on 32 31/05/2021 ECH003XN101-A5 If the device is dropped or if water penetrates, it is imperative to have the device checked by Électronique du Mazet to exclude any risk (patient and user) related to the use of the device.
-
Page 26: After-Sales Service And Warranty
Page 26 on 32 31/05/2021 ECH003XN101-A5 10 After-sales service and warranty This appliance is guaranteed by your supplier under the conditions specified in this document, provided that : ◼ Only accessories supplied or qualified by Électronique du Mazet should be used ◼... -
Page 27: Disposal
Page 27 on 32 31/05/2021 ECH003XN101-A5 11 Disposal 11.1 Accessories As soon as any damage to an accessory is detected, the product must be cleaned with a broad spectrum disinfectant and returned to the manufacturer. 11.2 Electronics If the product becomes inoperative or unusable, it should be returned to the manufacturer or taken to an ECOSYSTEM collection point. -
Page 28: Ce Declaration
Page 28 on 32 31/05/2021 ECH003XN101-A5 13 CE declaration ÉLECTRONIQUE DU MAZET can provide the CE declaration for this device on request. The first affixing of the medical CE to this device took place on september 2021. 14 Manufacturer Électronique du Mazet is a company located in the heart of the Massif Central. Originally a simple manufacturer of electronic cards, over the years it has developed its own brand of medical devices. -
Page 29: Emc Compliance Table
Page 29 on 32 31/05/2021 ECH003XN101-A5 15 EMC compliance table EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015) The Echodia range of products are intended for use in the electromagnetic environment specified below. The customer or user of the equipment should ensure that it is used in such an environment. Emissions testing Compliance Electromagnetic environment - guidelines... - Page 30 Page 30 on 32 31/05/2021 ECH003XN101-A5 Single-phase: Single-phase: at 0 degrees at 0 degrees 250/300 cycles 250/300 cycles Magnetic field Magnetic fields at the frequency of the mains power system should have levels 30 A/m 30 A/m frequency characteristic of a representative location in 50Hz or 60Hz 50Hz or 60Hz (50/60 Hz)
- Page 31 Page 31 on 32 31/05/2021 ECH003XN101-A5 b) Above the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3V/m. Recommended separation distances between portable and mobile RF devices and the Echodia range The Echodia range of devices is intended for use in an electromagnetic environment in which radiated RF interference is controlled.
- Page 32 Page 32 on 32 31/05/2021 ECH003XN101-A5 ELECTRONIQUE DU MAZET ZA ROUTE DE TENCE 43520 LE MAZET SAINT VOY Tél : +33 4 71 65 02 16 Mail : sav@electroniquedumazet.com Your dealer / distributor :...