Interacoustics Affinity Compact User manual

Instructions for Use - US
Affinity
Compact
Science
made
smarter
D-0123672-H – 2022/05

Table of Contents
1INTRODUCTION .................................................................................................................1
1.1 About this manual .......................................................................................................1
1.2 Intended use ..............................................................................................................1
1.3 Product description.....................................................................................................2
1.4 Standard and Optional parts........................................................................................3
1.5 Warnings and precautions ...........................................................................................4
2UNP ACKING AND INST ALL ATION .....................................................................................5
2.1 Unpacking and inspection ...........................................................................................5
2.2 Symbols.....................................................................................................................6
2.3 Important safety instructions........................................................................................7
2.3.1 Electrical system safety......................................................................................7
2.3.2 Electrical saf ety .................................................................................................7
2.3.3 Explosion hazards .............................................................................................8
2.3.4 Electromagnetic compatibility (EMC)...................................................................8
2.3.5 Cautions – General............................................................................................8
2.3.6 Environmental f actors ........................................................................................9
2.3.7 NOTICE ............................................................................................................9
2.4 Malfunction............................................................................................................... 10
2.5 Connection panel dictionary ...................................................................................... 11
2.6 Affinity Compact Indicators........................................................................................12
2.7 Sof tware installation.................................................................................................. 13
2.7.1 Sof tware installation Windows®11, Windows®10, , Windows®8.1, and
Windows®8.....................................................................................................14
2.8 Driver installation ......................................................................................................19
2.9 Using with databases ................................................................................................ 19
2.9.1 Noah 4............................................................................................................19
2.10 Standalone version ................................................................................................... 19
2.11 How to conf igure an alternative data recovery location................................................ 19
2.12 License ....................................................................................................................20
2.13 About Affinity Suite ...................................................................................................20
3OPERATING INST RUCTI ONS ........................................................................................... 21
3.1 Using the tone screen ...............................................................................................22
3.2 Using the speech screen ........................................................................................... 28
3.2.1 Speech audiometry in graph mode ................................................................... 30
3.2.2 Speech audiometry in table mode..................................................................... 31
3.2.3 PC keyboard shortcuts manager....................................................................... 33
3.2.4 Technical specifications of the AC440 Software................................................. 34
3.3 The REM440 screen ................................................................................................. 36
3.3.1 REM sof tware - Technical specif ications ........................................................... 43
3.4 The HIT440 screen ...................................................................................................44
3.4.1 HIT440 Software - Technical Specifications....................................................... 48
3.5 Using the print wizard................................................................................................50
4MAINTE NANCE ................................................................................................................ 53
4.1 General maintenanc e procedures ..............................................................................53
4.2 How to clean Interacoustics products ......................................................................... 53
4.3 Concerning repair ..................................................................................................... 54
4.4 Warranty ..................................................................................................................54
4.5 Replacement of consumables.................................................................................... 55
4.5.1 Foam tips........................................................................................................55
4.5.2 Probe tubes .................................................................................................... 55
4.5.3 SPL60 probe tubes.......................................................................................... 55

4.5.4 Ear tips ...........................................................................................................56
5GENERAL TE CHNICAL SPECIFICATIO NS ....................................................................... 57
5.1 Affinity Compact Hardware - Technical Specifications.................................................. 57
5.2 Tone reference equivalent threshold values for transducers ........................................ 59
5.3 Pin assignments ....................................................................................................... 72
5.4 Electromagnetic compatibility (EMC) ..........................................................................74

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1Introduction
1.1 About this manual
This manual is valid for the Af finity Compact. This product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelf art
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
1.2 Intended use
Indications for use
The Af finity Compact with AC440 is intended to be used f or the detection and diagnosis of suspected
hearing loss. The outcomes of which can be used f or further testing procedures and/or the f itting of hearing
aid devices.
The Af finity Compact with HIT440 is intended to be used for hearing instrument testing; a way to produce an
objective indication of the characteristics of hearing instruments inside an enclosed test chamber using a
coupler.
The Af finity Compact with REM440 is intended to be used for Real-Ear Measurement that takes care of all
clinical verif ication needs during hearing aid f itting. The process is such that reference microphones sit
outside of the ears whilst a small probe tube microphone is placed in each canal close to the subjects’ ear
drum. Sound pressure levels are measured to generate graphs which correspond to various tests that can
be performed in the REM440 module. Data sets are then gathered to validate and verif y hearing instrument
settings.
Intended operator
Trained operators like audiologist, hearing healthcare prof essional, or trained technician
Intended population
No restrictions
Contraindications
None known
Clinical Benefits
The Af f inity Compact with AC440 uses tonal and speech stimuli to provide the user with a representation of
whether there is a hearing loss present and the degree of any hearing loss. In turn, this allows the relevant
qualif ied operator to prescribe hearing instruments and f urther support any additional/ongoing otological
management.
The Af finity Compact with HIT440 provides objective measurements f rom hearing aids and assistive hearing
devices which can be compared against local standard protocols or hearing aid manufacturer specifications
to ensure consistency in quality and performance and to also detect any deviations from manuf acturer
specifications. This ensures the subject is always in receipt of ef fectively functioning hearing instruments.
The Af f inity Compact with REM440 provides the recipient of hearing instruments with objectively validated
and verified devices. It considers the unique quality of a subjects’ external auditory canal, thereby the
operator can accurately prescribe the device to targeted audibility levels.

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1.3 Product description
The Af finity Compact is a Hearing Aid Analyzer that interf aces with integrated audiologic software modules
on a PC. Depending on the installed sof tware modules it can perf orm:
•Audiometry (AC440)
•Real Ear Measurements (REM440) including Visible Speech Mapping
•Hearing Instrument Testing (HIT440)
PLEASE NOTE – This product is not a sterile device and is not intended to be sterilized bef ore use.

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1.4 Standard and Optional parts
AC440
REM440/VSP440
HIT440
Standard parts
•Affinity suite software
•DD45 Audiometric headset1
•MonitorHeadset
•Talk back microphone
•B81 Bone conductor1
•APS3 Patient response
button1
•Standard USB cable
•Powersupply -
UES65-240250SPA3
•Power cable
•Mouse pad
Optional parts
•IP30 insert earphones1
•B71 Bone Conductor1
•IP30 insert phone – single
sited
•Audiocup enclosures
•DD65 v21
•DD450 High frequency
headset1
•SP85A Loudspeaker
•SP90A Loudspeaker
•SP100 Loudspeaker
•10m cable forSP100
•EM400 Electret microphone
•Ambient noise microphone
•Accessory bracket
•Desktop bracket
•Table mount bracket
•Wall mount bracket
•Cable Extender Box
•Sound room kit
•OtoAccess® database
Standard parts
•Affinity suite software
•IHM65 In-situ headset1/ 2
•Probe tubes, 50 pcs.
•SPL60 Transducer kit for
RECD measurement
including probes and ear
tips4
•Coupler and microphone
kit4
o½” microphone
oReference
microphone
o2cc coupler
o0.4cc coupler
oBTE Short
oBTE Long
oITE
oRubber tubes
•Coupler seal wax4
•Aidapters4
•SP100 loudspeaker4
•Standard USB cable
•Powersupply -
UES65-240250SPA3
•Power cable
•Mouse pad
Optional parts
•Accessory bracket
•Desktop bracket
•Table mount bracket
•Wall mount bracket
•Battery adapters BAA675,
BAA13, BAA312, BAA10,
BAA5
•Coupler support
•Coupler support kit
•Ear simulator
•Monitor headset
•SP85A Loudspeaker
•SP90A Loudspeaker
•10m cable for SP100
•Travel trolly
•OtoAccess® database
Standard parts
•Aff inity suite software
•Coupler and microphone kit
o½” microphone
oReference
microphone
o2cc coupler
o0.4cc coupler
oBTE Short
oBTE Long
oITE
oRubber tubes
•Coupler seal wax
•Aidapters
•Standard USB cable
•Power supply - UES65-
240250SPA3
•Power cable
•Mouse pad
Optional parts
•Battery adapters BAA675,
BAA13, BAA312, BAA10,
BAA5
•Coupler support
•Coupler support kit
•Adaptor for Body Style HA
•Ear simulator
•SKS10 Skull Simulator with
power supply
•Tele coil
•Monitor headset
•Travel trolly
•OtoAccess® database
1Applied part according to IEC 60601-1
2This part is not certif ied according to IEC 60601-1
3Not included f or Affinity Compact version 1 & 2
4Optional part f or Affinity Compact version 2

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1.5 Warnings and precautions
Throughout this manual, the following def initions 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 this device to sale by or on the order of a licensed medical practitioner
WARNING
CAUTION

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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 f or the
carrier’s inspection and insurance claim.
Keep carton for future shipment
The Af finity Compact comes in its own shipping carton, which is specially designed f or the Af f inity Compact.
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 imperfections and missing parts.
Immediately report 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 Affinity Compact for a period, please ensure it is stored under the f ollowing
conditions:
Temperature; 0-50°C
Relative Humidity: 10-95% Non-condensing

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2.2 Symbols
The following symbols can be f ound on the instrument, accessories or packaging:
Symbol
Explanation
Type B applied parts
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 f acilities for recycling.
The CE-mark in combination with MD symbol indicates that Interacoustics A/S
meets the requirements of the Medical Device Regulation (EU) 2017/745 Annex I
Approval of the quality system is made by TÜV – identification no. 0123.
Medical Device.
Year of manufacture
Manufacturer
Serial number
Reference number
Indicates a component is intended for one use, or f or use on a single patient during
a single procedure. Cross contamination risk.
Stand by
Keep dry
Transport and storage temperature range
REF

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Transport and storage humidity limitations
ETL listing mark
Logo
2.3 Important safety instructions
Read these instructions carefully and completely before using the product
2.3.1 Electrical system safety
When connecting the instrument to the computer, the following warnings must
be observed:
This equipment is intended to be connected to other equipment thus forming a
Medical Electrical System. External equipment intended f or connection to
signal input, signal output or other connectors shall 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 – shall comply with the safety requirements stated the
general standard IEC 60601-1, edition 3, clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601-1 shall be kept
outside the patient environment i.e., at least 1.5 m from the patient support or
shall be supplied via a separation transf ormer 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 theref ore
responsible f or the system to comply with the requirements. If in doubt, contact
qualif ied medical technician or your local representative. If the instrument is
connected to a PC (IT equipment f orming a system) ensure not to touch the
patient while operating the PC.
A Separation Device (isolation device) is needed to isolate the equipment
located outside the patient environment f rom the equipment located inside the
patient environment. Such a Separation Device is required when a network
connection is made. The requirement for the Separation Device is def ined in
IEC 60601-1 clause 16
2.3.2 Electrical safety
Do not modify this equipment without authorization of Interacoustics Do not
disassemble or modify the product as this may impact on the saf ety and/or
performance of the device. Refer servicing to qualif ied personnel.
For maximum electrical saf ety, turn off the power when it is left unused
The power plug shall be placed so it is easy to pull out the plug
Do not use any additional multiple socket-outlet or extension cord.
Do not use the equipment if it is showing visible signs of damage.
WARNING
WARNING

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The instrument is not protected against ingress of water or other liquids. If any
spillage occurs, check the instrument caref ully bef ore use or return f or service
No part of the equipment can be serviced or maintained while in use with the
patient.
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
2.3.3 Explosion hazards
Do NOT use in the presence of f lammable gaseous mixtures. Users should
consider the possibility of explosions or f ire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the instrument in a highly oxygen-enriched environment, such as
a hyperbaric chamber, oxygen tent, etc.
Before cleaning make sure to disconnect power source
2.3.4 Electromagnetic compatibility (EMC)
Although the instrument f ulfills 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. Please also ref er to the
appendix regarding EMC.
Use of accessories, transducers, and cables other than specified, except f or
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 also
refer to the appendix regarding EMC.
2.3.5 Cautions – General
If the system is not functioning properly, do not operate it until all necessary
repairs are made and the unit is tested and calibrated for proper functioning in
accordance with Interacoustics’ specifications.
Do not drop or in any other way cause undue impact to this device. If the
instrument is damaged, return it to the manufacturer for repair and/or
calibration. Do not use the instrument if any damage is suspected.
This product and its components will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual,
accompanying labels, and/or inserts. A defective product should not be used.
Make sure all connections to external accessories are secured properly. Parts
which may be broken or missing or are visibly worn, distorted, or contaminated
should be replaced immediately with clean, genuine replacement parts
manufactured by or available from Interacoustics.
WARNING
CAUTION
CAUTION

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Interacoustics will make available on request circuit diagrams, component part
lists, descriptions, calibration instructions, or other information that will assist
authorized service personnel to repair those parts of this instrument that are
designated by Interacoustics as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the
patient.
Connect only accessories purchased from Interacoustics to the instrument.
Only accessories which have been stated by Interacoustics to be compatible
are allowed to be connected to the device.
Never insert, or in any way use, the insert headset without a new clean and
non-def ective ear-tip. Always make sure that the foam or ear-tip is mounted
correctly. Ear-tips and f oam are f or single use only.
The instrument is not intended f or use in environments exposed to f luid spills.
Check calibration if any parts of the equipment are exposed to shock or rough
handling.
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 f or ‘single use’ are not intended to be reprocessed.
Use only transducers calibrated with the actual instrument.
In case of a serious incident with serious health impact for the patient or user
Interacoustics shall be informed. Beside that the competent authority in
patient’s home country shall be inf ormed. Interacoustics has a vigilance
system to help with this.
2.3.6 Environmental factors
Storage outside temperature range as specified in Section 2.1 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can meet any of the
electronic components or wiring. Should the user suspect f luids have contacted
the system components or accessories, the unit should not be used until
deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind and allow
suf ficient space around the instrument to ensure proper ventilation.
2.3.7 NOTICE
To prevent system f aults, take appropriate precautions to avoid PC viruses and
similar.
Using operating systems where Microsoft have discontinued software and
security support will increase the risk for viruses and malware, which may result
in breakdowns, data loss and data theft and misuse.
CAUTION

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Interacoustics A/S cannot be held liable for your data. Some Interacoustics A/S
products support or may work with operating systems unsupported by Microsoft.
Interacoustics A/S recommends you to always use Microsoft supported operating
systems that are kept fully security updated.
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 theref ore must be collected separately. Such products
will be marked with the crossed-out wheeled bin symbol, shown below. The
cooperation of the user is important 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.
Outside the European Union, local regulations should be f ollowed when disposing
of the product after end of life.
2.4 Malfunction
In the event of a product malf unction, it is important to protect patients, users, and other
persons against harm. Therefore, if the product has caused, or potentially could cause such
harm, it must be quarantined immediately.
Both harmful and harmless malfunctions, related to the product itself or to its use, must
immediately be reported to the distributor where the product was acquired. Please remember to
include as many details as possible e.g., the type of harm, serial number of the product,
sof tware version, connected accessories and any other relevant inf ormation.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Interacoustics and the local national competent authority.

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2.5 Connection panel dictionary
Position:
Symbol:
Function:
1
Headset 2 Left and Ins.
Masker
Socket for Insert phone or HF Phone or Insert Masker
2
Headset 2 Right
Socket for Insert phone or HF Phone
3
Bone
Socket for Bone headset
4
Pat. Resp.
Socket for Patient Response Button
5
Monitor
Socket for Monitor Headset
6
Mic. –Talk F.
Socket for Talk forward Microphone
7
Ambient- Cal. Mic.
Socket for Ambient Noise Microphone or Automatic FF Verification
Microphone
8
AUX
Socket for line in from External Sound Source
9
Talk B.
Socket for Talk back Microphone
10
AC Headset Left
Socket for Left AC Phone or HF Phone
11
AC Headset Right
Socket for Right AC Phone or HF Phone
12
FF1 Power
Socket for power out to FF loudspeaker
13
FF2 Power
Socket for power out to FF loudspeaker
14
FF 1-2 Line
Socket for line output to FF loudspeaker
15
Insitu Headset
Socket for Insitu REM headset
16
UES65-240250SPA3
Socket for external power supply
17
USB-PC
Socket for USB connection to PC

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2.6 Affinity Compact Indicators
The Aff inity Compact hardware has an LED light indicator which changes status during different operations
of the Af finity Compact Suite and hardware. These dif f erent colours and their statuses are listed and shown
below.
The LED light is visible from both the front and the top of the Affinity Compact.
GREEN-Light: Ready
RED-Light: Indicates right ear selected in REM and HIT module
BLUE-Light: Indicates left ear selected in REM and HIT module
PURPLE-Light: Indicates both ears selected in REM and HIT module
LIGHT BLUE-Light: Indicates that the Aff inity Compact is not correctly connected to the Af finity
Compact Suite
A dimmed light indicates that the Aff inity Compact has entered power saving mode. This can happen in any of
the colours mentioned above.
Position:
Symbol:
Function:
1
Reference
Socket for Reference Microphone
2
Coupler
Socket for Coupler Microphone
3
Battery
Socket for Battery Simulator power out
4
Telecoil
Socket for Telecoil out

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2.7 Software installation
To know before you Start the Installation
You must have administrative rights to the computer on which you are installing the Affinity Compact Suite.
NOTICE
1. DO NOT connect the Affinity Compact hardware to the computer bef ore the software has been
installed.
2. Interacoustics will not make any guarantee to the functionality of the system if any other software is
installed, with exception of the Interacoustics measurement (AC440/REM440) modules and
AuditBase system4, OtoAccess®, or Noah4 compatible Office Systems or later releases.
What you will need:
1. Aff inity Compact Suite Installation USB Drive
2. USB Cable
3. Aff inity Compact Hardware
Supported Noah Office Systems
We are compatible with all Noah-integrated of f ice systems which are running on Noah and Noah engine.
To use the software in conjunction with a database, make sure the database is installed prior to the Affinity
Compact Suite installation. Follow the manufacturer’s installation instructions provided to install the relevant
database.
Note that if you are using AuditBase you must ensure to launch this of fice system prior to this installation of
the Af f inity Compact Suite.
NOTICE: As a part of data protection, ensure to be compliant to all the f ollowing points:
1. Use Microsoft supported operating systems
2. Ensure operating systems are security patched
3. Enable database encryption
4. Use individual user accounts and passwords
5. Secure psychical and network access to computers with local data storage
6. Use updated antivirus and firewall and anti-malware software
7. Implement appropriate backup policy
8. Implement appropriate log retention policy
Installation on various Windows® versions
Windows®8, Windows®10 and Windows®11 systems are supported.

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2.7.1 Software installation Windows®11, Windows®10, , Windows®8.1, and Windows®8
Insert the installation USB drive and f ollow the steps below to install the Affinity Suite sof tware. To f ind the
installation f ile; click “Start”, then go to “My Computer” and double click the USB drive to view the contents of
the installation USB. Double click the “setup.exe” file to initiate the installation.
Wait for the dialog shown below to appear, you must accept the license terms and conditions ahead of
installing. On checking the box to accept this, the Install button will become available, click “Install” to begin
the installation.
Note: There are also options to include the installation of Interacoustics Universe and Callisto documentation
within this step. They are by def ault checked on; you can disable this if you wish.
Make sure you are choosing Af finity Compact when selecting the hardware in this step.

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Should you wish to install the software to a dif f erent location than the def ault then please click on
’Options’ ahead of ’Install’

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User Account Control may ask if you want to allow the program to make changes to your computer.
Click Yes if this happens.
The installer will now copy all the necessary files to the PC. This process may take several minutes.