Interacoustics ad226 User manual

D-0102163-D - 2016/06
Instructions for Use –Part 1
AD226
Diagnostic Audiometer
EN Instructions for Use
DE Gebrauchsanweisung
FR Instructions d’utilisation
SV Bruksanvisning
DA Brugsanvisning
FI Käyttöohje
NO Bruksanvisning

Instructions for Use - EN
Diagnostic Audiometer 226

Table of Contents
1 INTRODUCTION........................................................................................ ................................. 1
1.1 About this Manual ............................................................................................................... 1
1.2 Intended Use....................................................................................................................... 1
1.3 Product Description............................................................................................................. 0
1.4 Warnings............................................................................................................................. 0
2 UNPACKING AND INSTALLATION.......................................................... ................................. 1
2.1 Unpacking and Inspection................................................................................................... 1
2.2 Marking ............................................................................................................................... 2
2.3 General Warnings and Precautions.................................................................................... 2
3 GETTING STARTED - SETUP AND INSTALLATION.............................. ................................. 5
3.1 Back Panel Connections –Standard Accessories.............................................................. 5
3.2 PC-Interface........................................................................................................................ 6
3.3 Operating instructions......................................................................................................... 6
3.4 Tone test............................................................................................................................. 9
3.5 Stenger Test...................................................................................................................... 10
3.6 ABLB Test......................................................................................................................... 10
3.7 Hughson-Westlake Test.................................................................................................... 11
3.8 Setup ................................................................................................................................ 11
3.9 Sessions and clients ......................................................................................................... 12
3.9.1 Save Session.......................................................................................................... 12
3.9.2 View client............................................................................................................... 12
4 CARE AND MAINTENANCE..................................................................... ............................... 13
4.1 General Maintenance Procedures .................................................................................... 13
4.2 How to clean Interacoustics Products............................................................................... 14
4.3 Concerning Repair............................................................................................................ 14
4.4 Warranty............................................................................................................................ 15
5 GENERAL TECHNICAL SPECIFICATIONS............................................. ............................... 17
5.1 Reference Equivalent Threshold Values for transducers ................................................. 19
5.2 Pin Assignments ............................................................................................................... 19
5.3 Electromagnetic Compatibility (EMC)............................................................................... 19

AD226 Instruction for Use - EN Page 1
1Introduction
1.1 About this Manual
This manual is valid for the AD226. These products are manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]om
Web: www.interacoustics.com
1.2 Intended Use
The AD226 diagnostic audiometer is designed to be a device for diagnosing hearing loss. Output and
specificity of this type of device are based on the test characteristics defined by the user, and may vary
depending on environmental and operating conditions. The diagnosing of hearing loss using this kind of
diagnostic audiometer depends on the interaction with the patient. However, for patients not responding well
possibilities of various tests allow the tester of having at least some evaluative result. Thus, a “normal
hearing” result should not allow for ignoring other contra indications in this case. A full audiologic evaluation
should be administered if concerns about hearing sensitivity persist.
The AD226 audiometer is intended to be used by an audiologist, hearing healthcare professional, or trained
technician in an extremely quiet environment according to the ISO standard 8253-1.. . This instrument is
intended for all patient groups regarding sex, age and health. Careful handling of instrument whenever in
contact with patient should be of high priority. Calm and stable positioning while testing is preferred for
optimal accuracy.

AD226 Instruction for Use - EN Page 0
1.3 Product Description
The AD226 is a 1½ channel portable audiometer offering air and bone conduction test capabilities with
masking. It offers a range of special test features such as SISI, HW, Stenger and Langenbeck.
As standard AD226 is delivered with the following:
1.4 Warnings
Throughout this manual the following meaning of warnings, cautions and notices are used:
Included parts
DD45 Audiometric headset
B71 Bone conductor
APS3 Patient response button
Power supply
Operation manual CD
Multilingual CE instructions for use
Optional parts
Diagnostic Suite software
OtoAccess database
21925 Amplivox audiocups, noise reducing headset
Carrying case (Standard or Trolly Style)
EARTone3A Audiometric insert phones
TDH39 Audiometric headset
CIR33 Insert earphone set for masking or monitoring
IP30 Insert phones
DD45 Audiometric headset P3100 (Pediatric headband)
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 is used to address practices not related to personal injury.

AD226 Instruction for Use - EN Page 1
2Unpacking 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 AD226 comes in its own shipping carton, which is specially designed for the AD226. 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.
Storage
If you need to store the AD226 for a period, please ensure it is stored uder the conditions specified in the
section for technical specifications.

AD226 Instruction for Use - EN Page 2
2.2 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.
Failing to do so may endanger the environment.
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.
Year of manufacture
Do not re-use
Parts like ear-tips and similar are for single use only
Type plate is located beneath the instrument
2.3 General Warnings and Precautions
External equipment intended for connection to signal input, signal output or other connectors shall comply
with relevant IEC standard (e.g. IEC 60950 for IT equipment). In these situations an optical isolator is
recommended to fulfill the requirements. Equipment not complying with IEC 60601-1 shall be kept outside
the patient environment, as defined in the standard (usually 1.5 meter). If in doubt, contact qualified medical
technician or your local representative.
This instrument does not incorporate any separation devices at connections for PC’s, printers, active
speakers etc. (Medical Electrical System)
When the instrument is connected to a PC and other items of equipment of a medical electrical system
assure that the total leakage current cannot exceed the safety limits and that separations have the dielectric
strength, creepage clearances and air clearances required fulfilling the requirements of IEC/ES 60601-1.
When the instrument is connected to a PC and other similar items be aware of not touching the PC and
patient simultaneously