Instructions for Use
85 Pages
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Science made smarter
Instructions for Use - EN
D-0123234-E – 2020/11
Affinity Compact
Table of Contents 1
INTRODUCTION ... 1 1.1 About this manual ... 1 1.2 Intended use... 1 1.3 Product description ... 1 1.4 Included and optional parts and accessories ... 2 1.5 Warnings and precautions ... 3
2
UNPACKING AND INSTALLATION ... 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 safety ... 7 2.3.3 Explosion hazards ... 8 2.3.4 Electromagnetic compatibility (EMC) ... 8 2.3.5 Cautions – General ... 8 2.3.6 Environmental factors ... 9 2.3.7 NOTICE ... 9 2.4 Malfunction ... 10 2.5 Connection panel dictionary ... 11 2.6 Affinity Compact Indicators ... 12 2.7 Software installation ... 13 2.7.1 Software installation Windows®7 ... 14 2.7.2 Software installation Windows®8.1 ... 17 2.7.3 Software installation Windows®10 ... 20 2.8 Driver installation ... 23 2.9 Using with databases ... 23 2.9.1 Noah 4 ... 23 2.10 Standalone version ... 23 2.11 How to configure an alternative data recovery location ... 23 2.12 License ... 24 2.13 About Affinity Suite ... 24
3
OPERATING INSTRUCTIONS ... 25 3.1 Using the tone screen ... 26 3.2 Using the speech screen ... 32 3.2.1 Speech audiometry in graph mode ... 34 3.2.2 Speech audiometry in table mode ... 35 3.2.3 PC keyboard shortcuts manager ... 37 3.2.4 Technical specifications of the AC440 Software ... 38 3.3 The REM440 screen ... 40 3.3.1 REM software - Technical specifications ... 47 3.4 The HIT440 screen ... 48 3.4.1 HIT440 Software - Technical Specifications ... 52 3.5 Using the print wizard ... 54
4
MAINTENANCE ... 57 4.1 General maintenance procedures ... 57 4.2 How to clean Interacoustics products ... 57 4.3 Concerning repair ... 58 4.4 Warranty ... 58
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GENERAL TECHNICAL SPECIFICATIONS ... 59 5.1 Affinity Compact Hardware - Technical Specifications ... 59 5.2 Tone reference equivalent threshold values for transducers ... 61 5.3 Pin assignments ... 74 5.4 Electromagnetic compatibility (EMC) ... 76
1 Introduction 1.1
About this manual
This manual is valid for the Affinity Compact. This product is manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] Web: www.interacoustics.com
1.2
Intended use
The Affinity Compact with AC440 is intended to be used for the detection and diagnosis of suspected hearing loss. The Affinity Compact with HIT440 is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. The Affinity Compact with REM440 is intended to be used for Real-Ear Measurement that takes care of all clinical verification needs. Intended operator Trained operators like audiologist, hearing healthcare professional, or trained technician.
1.3
Product description
The Affinity Compact is a Hearing Aid Analyzer that interfaces with integrated audiologic software modules on a PC. Depending on the installed software modules it can perform: • Audiometry (AC440) • Real Ear Measurements (REM440) including Visible Speech Mapping • Hearing Instrument Testing (HIT440)
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1.4
Included and optional parts and accessories AC440
REM440/VSP440
HIT440
Standard parts:
Standard parts:
Standardparts:
• • • • •
Affinity suite software DD45 Audiometric headset 1 Monitor Headset Talk back microphone B81 Bone conductorError!
•
APS3 Patient response buttonError! Bookmark not defined. Standard USB cable Power supply - UE60240250SPA3 Power cable Mouse pad
• • • •
Bookmark not defined.
Optional parts: •
Earphone 3A insert earphones Error! Bookmark not defined./2
•
IP30 insert earphones
•
B71 Bone Conductor
•
IP30 insert phone – single sited Audiocup enclosures DD65 v2Error! Bookmark not
• • •
Error!
Bookmark not defined.
Error!
Bookmark not defined.
• •
Affinity suite software IHM65 In-situ headsetError!
• •
• •
Probe tubes, 50 pcs. SPL60 Transducer kit for RECD measurement including probes and ear tips SP100 loudspeaker Standard USB cable Power supply - UE60240250SPA3 Power cable Mouse pad
• • •
• • • • •
Optional parts: • • • • • •
defined.
HDA300 Audiometric headsetError! Bookmark not defined.
•
DD450 High frequency headsetError! Bookmark not defined.
• • • • • • • • • • • •
SP85A Loudspeaker SP90A Loudspeaker SP100 Loudspeaker EM400 Electret microphone Ambient noise microphone Accessory bracket Desktop bracket Table mount bracket Wall mount bracket Cable Extender Box Sound room kit OtoAccess® database
Bookmark not defined./2
• • • • • •
Accessory bracket Desktop bracket Table mount bracket Wall mount bracket Battery adapters BAA675, BAA13, BAA312, BAA10, BAA5 Coupler and microphone kit o ½” microphone o Reference microphone o 2cc coupler o 0.4cc coupler o BTE Short o BTE Long o ITE o Rubber tubes Coupler seal wax Ear simulator Monitor headset SP85A Loudspeaker SP90A Loudspeaker OtoAccess® database
• •
Affinity suite software Coupler and microphone kit o ½” microphone o Reference microphone o 2cc coupler o 0.4cc coupler o BTE Short o BTE Long o ITE o Rubber tubes Coupler seal wax Standard USB cable Power supply - UE60240250SPA3 Power cable Mouse pad Optional parts:
• • • • • • •
Battery adapters BAA675, BAA13, BAA312, BAA10, BAA5 Adaptor for Body Style HA Ear simulator SKS10 Skull Simulator with power supply Tele coil Monitor headset OtoAccess® database
1 Applied part according to IEC 60601-1
2 This part is not certified according to IEC 60601-1
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1.5
Warnings and precautions
Throughout this manual, the following definitions of warning, caution and notice are used: WARNING
The WARNING label identifies conditions or practices that may present danger to the patient and/or user.
CAUTION
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
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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 Affinity Compact comes in its own shipping carton, which is specially designed for the Affinity 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 following conditions: Temperature; Relative Humidity:
0-50°C 10-95% Non condensing
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2.2
Symbols
The following symbols can be found 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 facilities for recycling. 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.
Medical Device.
Year of manufacture
Manufacturer
Serial number
REF
Reference number
Indicates a component is intended for one use, or for use on a single patient during a single procedure. Cross contamination risk.
Stand by
Keep dry
Transport and storage temperature range
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Transport and storage humidity limitations
ETL listing mark
Logo
2.3
Important safety instructions
2.3.1
Electrical system safety
Read these instructions carefully and completely before using the product
WARNING
2.3.2
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 for 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 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 the requirements. If in doubt, contact qualified medical technician or your local representative. If the instrument is connected to a PC (IT equipment forming 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 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
Electrical safety WARNING
Do not modify this equipment without authorization of Interacoustics Do not disassemble or modify the product as this may impact on the safety and/or performance of the device. Refer servicing to qualified personnel. For maximum electrical safety, 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.
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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 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 WARNING
Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire 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) CAUTION
Although the instrument fulfills 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 refer to the appendix regarding EMC. 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 also refer to the appendix regarding EMC.
2.3.5
Cautions – General CAUTION
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.
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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-defective ear-tip. Always make sure that the foam or ear-tip is mounted correctly. Ear-tips and foam are for single use only. The instrument is not intended for use in environments exposed to fluid 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 reused. Components marked for ‘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 informed. Interacoustics has a vigilance system to help with this.
2.3.6
Environmental factors CAUTION
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 come into contact with any of the electronic components or wiring. Should the user suspect fluids 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 sufficient space around the instrument to ensure proper ventilation.
2.3.7
NOTICE
To prevent system faults 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.
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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 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. Outside the European Union, local regulations should be followed when disposing of the product after end of life.
2.4
Malfunction In the event of a product malfunction, 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, software version, connected accessories and any other relevant information. 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: 1 2 3 4 5 6 7
Symbol: Headset 2 Left and Ins. Masker Headset 2 Right Bone Pat. Resp. Monitor Mic. –Talk F. Ambient- Cal. Mic.
8 9 10 11 12 13 14 15 16 17
AUX Talk B. AC Headset Left AC Headset Right FF1 Power FF2 Power FF 1-2 Line Insitu Headset UE60-240250SPA3 USB-PC
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Function: Socket for Insert phone or HF Phone or Insert Masker Socket for Insert phone or HF Phone Socket for Bone headset Socket for Patient Response Button Socket for Monitor Headset Socket for Talk forward Microphone Socket for Ambient Noise Microphone or Automatic FF Verification Microphone Socket for line in from External Sound Source Socket for Talk back Microphone Socket for Left AC Phone or HF Phone Socket for Right AC Phone or HF Phone Socket for power out to FF loudspeaker Socket for power out to FF loudspeaker Socket for line output to FF loudspeaker Socket for Insitu REM headset Socket for external power supply Socket for USB connection to PC
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Position: 1 2 3 4
Symbol: Reference Coupler Battery Telecoil
Function: Socket for Reference Microphone Socket for Coupler Microphone Socket for Battery Simulator power out Socket for Telecoil out
2.6 Affinity Compact Indicators
The Affinity Compact hardware has an LED light indicator which changes status during different operations of the Affinity Compact Suite and hardware. These different 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: RED-Light: BLUE-Light: PURPLE-Light: LIGHT BLUE-Light:
Ready Indicates right ear selected in REM and HIT module Indicates left ear selected in REM and HIT module Indicates both ears selected in REM and HIT module Indicates that the Affinity Compact is not correctly connected to the Affinity Compact Suite
A dimmed light indicates that the Affinity Compact has entered power saving mode. This can happen in any of the colours mentioned above.
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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 before 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. Affinity Compact Suite Installation USB Drive 2. USB Cable 3. Affinity Compact Hardware Supported Noah Office Systems We are compatible with all Noah-integrated office 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 office system prior to this installation of the Affinity Compact Suite. NOTICE: As a part of data protection, ensure to be compliant to all the following 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® 7 (32 and 64 bit), Windows®8 and Windows®10 systems are supported. Software Installation on Windows® 7 Insert the installation USB and follow the steps below to install the Affinity Compact Suite software. To find the installation file; click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB. Double click the “AffinitySuiteSetup.exe” file to initiate the installation.
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2.7.1 Software installation Windows®7
Insert the installation USB and follow the steps below to install the Affinity Compact Suite software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB. Double click the “AffinitySuiteSetup.exe” file to initiate the installation. 1. Wait for the dialog shown below to appear, please specify which hardware you wish to install the software for. You must also 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.
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Should you wish to install the software to a different location than the default then please click on ’Options’ ahead of ’Install’
2. User Account Control may ask if you want to allow the program to make changes to your computer. Click Yes if this happens.
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3. The installer will now copy all the necessary files to the PC. This process may take several minutes.
4. When the installation is complete, the dialog box below is shown.
5. Click “Close” to finish the installation. The Affinity Compact/Equinox Suite is now installed.
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