Interacoustics MT10 User manual

D-0100255-F – 2017/11
Instructions for Use – Part 1
MT10
Handheld Impedance
Tympanometer
EN Instructions for Use
DE Gebrauchsanweisung
FR Instructions d’utilisation
SV Bruksanvisning
EL Οδηγίες Χρήσης
IT Istruzioni per l’uso
PT Instrucções para a utilização
DA Brugsanvisning
FI Käyttöohje
ES Manual de instrucciones

nstructions for Use - EN
Hand Held Impedance Tympanometer MT10

Table of Contents
1. Introduction...................................................................................................................1
1.1 About this Manual ............................................................................................................... 1
1.2 Intended Use....................................................................................................................... 1
1.3 Product Description............................................................................................................. 1
1.4 Warnings and Precautions.................................................................................................. 2
2. Unpacking and Installation.............................................................................................3
2.1 Unpacking and Inspection................................................................................................... 3
2.2 Safety Regulations.............................................................................................................. 3
2.3 Marking ............................................................................................................................... 4
2.4 Connections........................................................................................................................ 4
3. Operating instructions ...................................................................................................5
3.1 Installing & replacing batteries............................................................................................ 5
3.2 Controls and indicators ....................................................................................................... 5
3.3 The Probe ........................................................................................................................... 6
3.4 Start up and menu display.................................................................................................. 7
3.5 MT10 – Menu Summery ..................................................................................................... 7
3.5.1 Main menu Selections .............................................................................................. 7
3.5.2 Sub-Menu Selections................................................................................................ 7
4. Maintenance...............................................................................................................................11
4.1 General Maintenance Procedure...................................................................................... 11
4.2 Cleaning the Accessories ................................................................................................. 11
4.3 Calibration and Return of the Instrument.......................................................................... 11
4.4 How to clean Interacoustics Products............................................................................... 11
4.5 Concerning Repair............................................................................................................ 12
4.6 Warranty............................................................................................................................ 12
5. Technical Specifications...........................................................................................................15
5.1 Electromagnetic Compatibility (EMC)............................................................................... 17
Data Transfer Guide

MT10 Instruction for Use - EN Page 1
1. Introduction
1.1 About this Manual
This manual is valid for the hand held tympanometer MT10.
Manufacturer: Manufactured for:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
1.2 Intended Use
The MT10 is a handheld screening tympanometer offering Tympanometry and optional Ipsi reflex
testing. The MT10 allows storing of data by printing (optional printer) or by transferring data to a
computer (optional software module).
The MT10 tympanometer is intended to be used by an audiologist, hearing healthcare professional, or
trained technician in a quiet environment (tymp and reflexes).
1.3 Product Description
The MT10 is designed for use by audiologists, general practitioners, hearing aid dispensers and child
health professionals. The instrument performs two types of measurement:
Tympanometry is used to measure the compliance of the tympanic membrane and middle ear at a
fixed frequency over a range of pressures.
Optional:
Reflex tests are used to measure stapedial reflexes. The MT10 measures ipsilateral reflexes and,
when selected, reflex measurement is automatically carried out after a tympanogram is taken.
The system includes the following included and additional parts:
Included Parts MT10:
4 x 1.5V ‘AA’ Batteries
Set of disposable ear-tips
Instructions for UseCalibration certificate
Warranty card
Additional Parts:
4 in 1 test cavity assembly
Carrying case
Portable thermal printer
2 rolls of thermal paper
Diagnostic Suite and OtoAccess™
Infra-red USB Adapter
Additional probe tip
Additional sets of ear tips

MT10 Instruction for Use - EN Page 2
1.4 Warnings and Precautions
1. The instrument is not intended to be used in oxygen rich environments or use in conjunction
with flammable agents.
1. The instrument is not intended to be used in environments exposed to fluid spills.
2. Ear tip are single use only.
3. Do not insert or in any way try to conduct measurements without proper probe eartip in place.
NOTICE
1. Be sure to insert the probe tip in a way which will assure an air tight fit without causing any
harm to the patient. Using a proper and clean ear tip is mandatory.
2. Be sure to use only stimulation intensities acceptable for the patient.
3. Never clean the transducer housing with water or insertion instruments.
4. Although the instrument fulfils the relevant EMC requirements precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the
device is used adjacent to other equipment it must be observed that no mutual disturbance
appears.
Within the European Union it is illegal to dispose electric and electronic
waste as unsorted municipal waste. Electric and electronic waste may
contain hazardous substances and therefore has to be collected separately.
Such products will be marked with the crossed-out wheeled bin shown
below. The cooperation of the user is important in order to ensure a high
level of reuse and recycling of electric and electronic waste. Failing to
recycle such waste products in an appropriate way may endanger the environment and
consequently the health of human beings.
WARNING indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in minor or moderate injury.
NOTICE NOTICE is used to address practices not related to personal injury

MT10 Instruction for Use - EN Page 3
2. Unpacking and Installation
2.1 Unpacking and Inspection
Check box and contents for damage
When the instrument is received please check the shipping box for rough handling and damage. If the
box is damaged it should be kept until the contents of the shipment have been checked mechanically
and electrically. If the instrument is faulty please contact your local distributor. Keep the shipping
material for the carrier’s inspection and insurance claim.
Keep carton for future shipment
The MT10 comes in its own shipping carton, which is specially designed for the MT10. Please keep
this carton. It will be needed if the instrument has to be returned for service.
If service is required please contact your local distributor.
Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. All of the cabinet and
the accessories should be checked visually for scratches and missing parts.
Report immediately any faults
Any missing part or malfunction should be reported immediately to the supplier of the instrument
together with the invoice, serial number, and a detailed report of the problem. In the back of this
manual you will find a "Return Report" where you can describe the problem.
Please use "Return Report"
Please realise that if the service engineer does not know what problem to look for he may not find it,
so using the Return Report will be of great help to us and is your best guarantee that the correction of
the problem will be to your satisfaction.
2.2 Safety Regulations
Electrical Safety:
This audiometer is specified to comply with the international standard IEC 60601-1.
The instrument is not intended to be used in oxygen rich environments or use in conjunction with
flammable agents.

MT10 Instruction for Use - EN Page 4
2.3 Marking
The following marking can be found on the instrument:
Symbol
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be immediately
released from the patient.
Refer to instruction manual
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product,
it must be sent to separate collection facilities for recovery and recycling.
0123
The CE-mark indicates that Interacoustics A/S meets the requirements of
Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service,
Identification No. 0123, has approved the quality system.
The number next to the symbol indicates the year of manufacture.
Do not re-use
Parts that are marked with this symbol are for single use only.
Label to be found in the battery compartment beneath the battery.
2.4 Connections
Infrared adapter (the MT10 has been tested with Actysis ACTIR2000U USB adapter and it is
recommended by Interacoustics to use this device).