Interacoustics AA222 User manual

Instructions for Use
AA222
Impedance Audiometer
D-0113181-B – 2017/05
English
Инструкция по применению
United States (USA)
Istruzioni d’uso
Instrukcja użycia
Οδηγίες χρήσης - Ελληνικά
Manual de Uso
Bedienungsanleitung
Návod k použitı
Instruções de Uso
使用说明

Table of Contents
1Introduction ..........................................................................................................................1
1.1 About this manual...................................................................................................................1
1.2 Intended use...........................................................................................................................1
1.2.1 Contraindications for performing impedance audiometry............................................1
1.3 Product description.................................................................................................................2
1.4 Warnings and precautions .....................................................................................................3
2Unpacking and installation .................................................................................................5
2.1 Unpacking and inspection......................................................................................................5
2.2 Symbols..................................................................................................................................6
2.3 Important safety instructions..................................................................................................8
2.4 Connections .........................................................................................................................10
2.4.1 Changing probe system.............................................................................................11
2.4.2 Safety precautions to take when connecting the AA222...........................................11
2.5 License.................................................................................................................................13
3Operating instructions.......................................................................................................15
3.1 AA222 operation panel.........................................................................................................16
3.2 Startup..................................................................................................................................20
3.3 Instrument settings...............................................................................................................20
3.4 About....................................................................................................................................22
3.5 Clients and session handling ...............................................................................................23
3.5.1 Clients ........................................................................................................................23
3.5.2 View historical sessions.............................................................................................25
3.5.3 Save session..............................................................................................................26
3.6 Operating instructions – Impedance ....................................................................................27
3.6.1 Calibration cavities.....................................................................................................27
3.6.2 Handling and selection of ear tips..............................................................................27
3.6.3 Probe status...............................................................................................................28
3.6.4 Tympanometry test screen ........................................................................................29
3.6.5 Reflex test screen ......................................................................................................31
3.6.6 Reflex decay test screen............................................................................................33
3.6.7 Reflex latency test screen (extended license) ...........................................................34
3.6.8 Eustachian tube function – Non-perforated eardrum.................................................34
3.6.9 Eustachian tube function – perforated eardrum.........................................................36
3.6.10 Eustachian tube function – patulous eustachian tube (extended license).................37
3.7 Operating instructions – audiometry ....................................................................................38
3.7.1 Tone audiometry test screen .....................................................................................38
3.8 Operating in sync mode (only with the Diagnostic Suite).....................................................49
3.8.1 PC power configuration..............................................................................................49
3.8.2. Starting from OtoAccess™ ........................................................................................49
3.8.3 Starting from Noah 4..................................................................................................49
3.8.4 Crash report...............................................................................................................49
3.8.5 Instrument setup ........................................................................................................50
3.9 Using sync mode..................................................................................................................51
3.9.1 Using IMP sync..........................................................................................................51
3.9.2 Using AUD sync.........................................................................................................53
3.9.3 Sync mode .................................................................................................................55
3.9.4 Client upload ..............................................................................................................55
3.9.5 Session download......................................................................................................56

4Maintenance........................................................................................................................57
4.1 General maintenance procedures........................................................................................57
4.2 Cleaning the probe tip..........................................................................................................59
4.3 Repair...................................................................................................................................60
4.4 Warranty...............................................................................................................................60
4.5 Periodic calibration...............................................................................................................61
5Technical specifications....................................................................................................63
5.1 Calibration Properties...........................................................................................................68
5.2 Reference equivalent threshold values for transducers.......................................................72
5.2.1 Impedance - Frequencies and intensity ranges.........................................................72
5.2.2 Audiometry – Survey of reference and max hearing level tone audiometry..............73
5.3 Pin Assignments...................................................................................................................82
5.4 Electromagnetic compatibility (EMC) ...................................................................................84

AA222 Instructions for Use - EN Page 1
1Introduction
1.1 About this manual
This manual is valid for the AA222 (Model 1078) firmware version 1.10.
The product is manufactured by:
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
Indications for use
The Interacoustics Audio Traveller AA222 is intended for use by trained operators in hospitals, nurseries,
ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of
possible otologic disorders. The AA222 is a combination of audiometer and tympanometer, which reduces
the amount of equipment necessary.
Intended operator
Trained operators like audiologist, hearing healthcare professional, or trained technician
Intended population
No restrictions
1.2.1 Contraindications for performing impedance audiometry
•Recent stapedectomy or other middle ear surgery
•Discharging ear
•Acute external auditory canal trauma
•Discomfort (e.g. severe otitis externa)
•Occlusion of the external auditory canal
•Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when
high intensity stimuli are used
Tympanometry should not be performed on patients with the above-mentioned symptoms without a medical
doctor’s approval.
Visual inspection for obvious structural abnormalities of the external ear structure and positioning as well as
the external ear canal should be performed before testing.

AA222 Instructions for Use - EN Page 2
1.3 Product description
The AA222 consists of the following parts:
Included parts
AA222 instrument
Power supply unit UE60-240250SPA3
Operation manual CD including Additional Information
Multilingual instructions for use
Cleaning cloth
Clinical probe system and/or Diagnostic probe system1
Contralateral headphone1
Assortment bag BET55
Floss kit
Daily check cavity
Audiometric headset1
Monitor headset
Bone conductor1
APS3 Patient response1
Optional parts
Printer kit including MTPIII printer
Wall mount
CAT50 calibration cavities
IP30 Insert contra headphone1
CIR insert earphone1
TDH39 contra headphone1
Amplivox audiocups, noise reducing headset1
EARTone3A/5A Audiometric insert phones1
IP30 Audiometric insert phones1
HDA300 Audiometric headset with double mono 6.3mm jack1
HDA280 Audiometric headset 1
TDH39 Audiometric headset1
Free field speaker
Talk back microphone
Diagnostic Suite software
OtoAccessTM database
1Applied part as according to IEC60601-1

AA222 Instructions for Use - EN Page 3
1.4 Warnings and precautions
Throughout this manual, the following definitions of warning, caution and notice are used:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE NOTICE is used to address practices not related to personal injury.
Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a licensed medical
practitioner.
WARNING
CAUTION

AA222 Instructions for Use - EN Page 4

AA222 Instructions for Use - EN Page 5
2Unpacking and installation
2.1 Unpacking and inspection
Keep the shipping box for future shipment
Please store the AA222 shipping box. It will be needed if the instrument has to be returned for service. If
service is required please contact your local distributor.
Inspect before connection
Prior to connecting the product it should be inspected for damage again. 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 the "Return Report"
Use of the Return Report provides the service engineer with the relevant information to investigate the
reported issue. Without this information, there may be difficulty in determining the fault and repairing the
device. Please always return the device with a completed Return Report in order to guarantee that correction
of the problem will be to your satisfaction.
Storage
If you need to store the AA222 for a period, please ensure that it is stored under the conditions specified in
the section for technical specifications.

AA222 Instructions for Use - EN Page 6
2.2 Symbols
The following symbols can be found on the instrument, accessories or packaging:
Symbol
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be released immediately
from the patient.
Follow instructions for use
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 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.
Year of manufacture
Manufacturer
Serial number
Reference number
Indicates a component is intended for one use, or for use on a single patient
during a single procedure
Display Port Connection – HDMI type
“ON” / “OFF” (push-push)
Keep dry
Transport and storage temperature range
REF

AA222 Instructions for Use - EN Page 7
Transport and storage humidity limitations
4005727
Conforms to
ANSI/AAMI ES60601-1:2005/A1:2
C er t i f i ed t o
CAN/CSA-C22.2 No. 60601-1:20
ETL CLASSIFIED
ETL listing mark
Logo

AA222 Instructions for Use – EN Page 8
2.3 Important safety instructions
Read these instructions carefully and completely before using the product
1. This equipment is intended to be connected to other equipment thus forming a Medical Electrical
System. External equipment intended for connection to signal input, signal output or other connectors
must comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-
series for medical electrical equipment. In addition, all such combinations – Medical Electrical Systems –
must comply with the safety requirements stated in the general standard IEC 60601-1, (edition 3.1),
clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 must be
kept outside the patient environment i.e. at least 1.5m from the patient support or must be supplied via a
separation transformer to reduce the leakage currents. Any person who connects external equipment to
signal input, signal output or other connectors has formed a Medical Electrical System and is therefore
responsible for the system to comply with these requirements. If in doubt, contact a qualified medical
technician or your local representative. When the instrument is connected to a PC, or other similar items,
beware of not touching the PC and patient simultaneously.
2. A Separation Device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular such a Separation
Device is required when a network connection is made. The requirement for the Separation Device is
defined in IEC 60601-1 clause 16.
3. To avoid the risk of electric shock, this equipment must only be connected to supply mains with a
protective earth.
4. Do not use any additional multiple socket-outlet or extension cord. For safe setup please refer to section
2.4.2
5. This instrument contains a coin-type lithium battery. The cell can only be changed by service personnel.
Batteries may explode or cause burns, if disassembled, crushed or exposed to fire or high temperatures.
Do not short-circuit.
6. No modification of this equipment is allowed without the authorization of Interacoustics.
Interacoustics will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information. This will assist service personnel to repair, the parts of this
audiometer that are designated by the Interacoustics service personnel as repairable.
7. For maximum electrical safety, turn off the power to a mains- powered instrument when it is left unused.
8. The instrument is not protected against ingress of water or other liquids. If any spillage occurs, check the
instrument carefully before use or return for service.
9. No part of the equipment can be serviced or maintained while in use with the patient.
10. Do not use the equipment if it is showing visible signs of damage.
1. Never insert, or in any way use, the insert headset without a new clean and non-defective test tip.
Always make sure that the foam or ear-tip is mounted correctly. Ear tips and foam are for single use
only.
2. The instrument is not intended for use in environments exposed to fluid spills.
3. The instrument is not intended for use in oxygen rich environments or for use in conjunction with
flammable agents.
WARNING
CAUTION

AA222 Instructions for Use – EN Page 9
4. Check calibration if any parts of the equipment are exposed to shock or rough handling.
5. Components marked for “single use” are intended for a single patient during a single procedure, and
there is a risk of contamination if the component is re-used.
Components marked for “single use” are not intended to be reprocessed.
NOTICE:
1. To prevent system faults take appropriate precautions to avoid PC viruses and similar.
2. Use only transducers calibrated with the actual instrument. To identify a valid calibration, the serial
number for the instrument will be marked on the transducer.
3. 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 monitored to ensure that there is no mutual disturbance. Please
also refer to EMC considerations in section 5.3.
4. Use of accessories, transducers and cables other than specified, with the exception of transducers and
cables sold by Interacoustics or representatives, may result in increased emission or decreased
immunity of the equipment. For a list of accessories, transducers and cables that fulfil the requirements
please refer to section 5.3.
5. Within the European Union, it is illegal to dispose of electric and electronic items in 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 symbol, 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.
6. Outside the European Union, local regulations should be followed when
disposing of the product after end of life.

AA222 Instructions for Use – EN Page 10
2.4 Connections
The back panel contains the connectors (sockets):
1
Probe
Dedicated probe connection
2
Contra
Contra probe connection
3
Assist Mon.
Assisting Monitor (monitor headset)
4
FF1
Free field 1
5
FF2
Free field 2
6
LAN
LAN (Not used)
7
USB B
For PC connection
8
USB A
For printer, mouse, keyboard, memory stick
9
HDMI
For external monitor or projector
10
In 24 V
Use only specified power supply unit UE60-240250SPA3 type
11
Pat. Resp.
Patient response button
12
Right
Audiometry Right output
13
Left
Audiometry Left output
14
Bone
Audiometry Bone output
15
TF
Talk forward (monitor headset microphone)
16
TB
Talk back
17
CD
CD for CD input

AA222 Instructions for Use – EN Page 11
2.4.1 Changing probe system
Change between the standard and clinical probe as follows:
1. Locate the probe connection on the back of the unit.
2. Open the 2 locks by pushing them to the sides.
3. Swap to the other probe system.
4. Close the 2 locks by pushing them to the center.
2.4.2 Safety precautions to take when connecting the AA222
Please note that if connections are made to standard equipment such as printers and networks, special
precautions must be taken in order to maintain medical safety. Please refer to section 2.3.
Use only specified power supply unit UE60-240250SPA3 type.
WARNING
WARNING

AA222 Instructions for Use – EN Page 12
Please follow the instructions below.
Fig 1. AA222 used with the medically approved power supply UE60-240250SPA3.
Fig. 2. AA222 used with a medically approved safety transformer and a wired connection to a PC.

AA222 Instructions for Use – EN Page 13
Fig. 3. AA222 used with the medically approved power supply UE60-240250SPA3 and optical USB
connection to a PC.
Fig. 4. AA222 used with the medically approved power supply UE60-240250SPA3 and printout with MPT-
III printer.
The separable mains plug for UE60-240250SPA3 is used to safely disconnect
mains from the device. Do not position the power supply in a position so that it
is difficult to disconnect the device.
2.5 License
When you receive the AA222, it already contains the license you have ordered. If you would like to add
licenses that are available for the AA222, please contact your local distributer.
WARNING

AA222 Instructions for Use – EN Page 14

AA222 Instructions for Use – EN Page 15
3Operating instructions
When operating the instrument, please observe the following guidelines:
1. Use this device only as described in this manual.
2. Use only the disposable SanibelTM ear tips designed for use with this instrument.
3. Always use a new ear tip for each patient to avoid cross-contamination. The ear tip is not designed
for reuse.
4. Never insert the probe tip into the ear canal without affixing an ear tip as this may damage the
patient’s ear canal.
5. Keep the box of ear tips outside the reach of the patient. Risk of choking.
6. Be sure to insert the probe tip in a way which will assure an airtight fit without causing any harm to
the patient. Use of a correct and clean ear tip is mandatory.
7. Be sure to use only stimulation intensities acceptable to the patient.
8. When presenting contralateral stimuli using the insert phones – do not insert the phones, or in any
way try to conduct measurements, without a correct insert ear tip in place.
9. Clean the headphone cushion regularly using a recognized disinfectant (70% isopropyl alcohol).
10. The presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing
when high intensity stimuli are used.
NOTICE
1. Careful handling of the probe system whenever in contact with a patient should be given high
priority. Calm and stable positioning while testing is preferred for optimal accuracy.
2. The AA222 should be operated in a quiet environment, so that measurements are not influenced by
external acoustic noises. This may be determined by an appropriately skilled person trained in
acoustics. ISO 8253-1 Section 11, defines guidelines for permissible ambient noise for audiometric
hearing testing.
3. It is recommended that the instrument be operated within an ambient temperature range of
15°C/59°F-35°C/95°F.
4. The headphone and insert phone are calibrated to the AA222 – introducing transducers from other
equipment requires a re-calibration.
5. Never clean the transducer housing with water or insert non-specified instruments into the
transducer.
6. Do not drop or cause any other undue impact to this device. If the instrument is dropped or in any
other way damaged, return it to the manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
CAUTION

AA222 Instructions for Use – EN Page 16
3.1 AA222 operation panel
Name
Description
1
Turns the AA222 ON/OFF.
2
Shift
The shift key activates the sub functions of the other keys.
3
Clients
Press the Clients button to open a window in which a client can be selected,
edited or created. Also its historic sessions can be viewed.
4
Setup
Hold down Setup and use the wheel (19) to select the desired Setup menu
then let go of the Setup button to open it.
5-14
Function keys
The 10 function keys hold functions displayed on the screen directly above the
individual F-key
15
Tests
Hold down Test and use the wheel (34/38) to select the desired protocol with
the module or switch between the audiometry and impedance module. Let go
of the Test button to make your selection.
16
Del Point
Del curve
Delete points during audiometry testing.
Delete the entire audiometry threshold curve of a graph by holding ‘shift (2)’
together with this button.
17
Save session
New session
Saves the current session including audiometry and impedance measures.
Create a new session by pressing ‘shift (2)’ together with this button. A new
session will recall the default settings.
18
Print
Prints the session that is currently selected to the printer setup in the
Instrument settings.