Interacoustics VRA201 User manual

Instructions for Use – Part 1
VRA201
Science made smarter
8521412 D-0125524-A – 2020/03
EN Instructions for Use
DE Gebrauchsanweisung
SV Bruksanvisning
DA Brugsanvisning
NO Bruksanvisning
FR Instructions d‘utilisation
ES Manual de instrucciones
IT Istruzioni per l‘uso
PL Instrukcja obsługi

Instructions for Use - EN

Table of contents
1Introduction ......................................................................................................................................... 1
About this manual...........................................................................................................................1
Intended use...................................................................................................................................1
Contraindications............................................................................................................................1
Product description.........................................................................................................................1
Warnings ........................................................................................................................................2
2Unpacking and installation ................................................................................................................ 3
2.1 Unpacking and inspection ..............................................................................................................3
2.2 Reporting imperfections .................................................................................................................3
2.3 Markings.........................................................................................................................................4
2.4 Safety precautions..........................................................................................................................5
Cautions – general...............................................................................................................5
Environmental factors ..........................................................................................................5
Electrical and electrostatic safety.........................................................................................6
Electromagnetic compatibility (EMC)...................................................................................6
Miscellaneous ......................................................................................................................6
Use of equipment after transport and storage .....................................................................7
3Operating instructions ....................................................................................................................... 9
3.1 How to operate VRA201 ................................................................................................................9
3.2 Connection panel dictionary...........................................................................................................9
3.3 Safety precautions when connecting the VRA201.........................................................................9
4Maintenance ...................................................................................................................................... 11
4.1 General maintenance procedures............................................................................................... 11
4.2 Repair.......................................................................................................................................... 11
4.3 Warranty...................................................................................................................................... 11
5General technical specification....................................................................................................... 13
5.1 VRA – technical specifications .................................................................................................... 13
5.2 General information about specifications.................................................................................... 13
5.3 Electromagnetic Compatibility (EMC) ......................................................................................... 14

VRA201 - Instructions for Use - EN Page 1
1Introduction
About this manual
This manual is valid for the Interacoustics VRA201. This 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
Intended use
The Interacoustics VRA201 is a manually controlled visual reinforcement tool. The tool is aimed at giving
visual rewards to pediatric patients in order to keep their focus during tests.
Contraindications
None known.
Product description
The Interacoustics VRA201 is a box with a toy animal hidden behind a dark plexiglass. By means of a push
on a response switch, the toy animal is illuminated and starts moving.
This device thereby provides visual reinforcement for children that are tested for their hearing capability with
illumination and movement.
Included parts:
VRA201 box
Power supply UES24LCP-120200SPA
Patient response APS3
Instructions for Use Multilingual

VRA201 - Instructions for Use - EN Page 2
Warnings
Throughout this manual, the following meanings of warning, caution and notice apply:
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.

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2Unpacking and installation
2.1 Unpacking and inspection
Check box and contents for damage
When you receive VRA201, please check the shipping box for rough handling and damage. If the box is
damaged, you should keep it until the contents of the shipment have been checked mechanically and
electrically. If your VRA201 is faulty, please contact your local distributor. Keep the shipping material for the
carrier’s inspection and insurance claim.
Keep carton for future shipment
VRA201 comes in its own shipping carton, which is specially designed for the VRA201 system. Please keep
this carton. You will need it should you need to return VRA201 for service.
If service is required, please contact your local distributor.
2.2 Reporting imperfections
Inspect before connection
Prior to connecting the product, you should inspect it once more for damage. You should visually check the
cabinet and the accessories for scratches and missing parts.
Report any faults immediately
Any missing parts or malfunctions should be reported immediately to the supplier of the instrument together
with the invoice, serial number, and a detailed report of the problem. At the end 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 a satisfactory
repair.

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2.3 Markings
The following markings can be found on the instrument:
Symbol
Explanation
Type B applied parts. According to IEC 60601-1.
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 recovery and recycling. Failing
to do so may endanger the environment.
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.
Serial number.
Date of manufacture.
Manufacturer.
Reference number.
Keep dry.
Transport and storage humidity range.
Transport and storage temperature range.
Logo.

VRA201 - Instructions for Use - EN Page 5
2.4 Safety precautions
Read these instructions carefully and completely before using the product.
Cautions – general
If the system is not functioning properly, do not use it until all necessary repairs are made and the unit
is tested 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. 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 or distorted should be replaced
immediately with clean, genuine replacement parts manufactured by or available from Interacoustics.
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.
Only connect accessories purchased from Interacoustics to the instrument. Only accessories, which
have been stated by Interacoustics as compatible, may be connected to the device.
The instrument is not intended for use in environments exposed to fluid spills.
Environmental factors
Storage in temperatures outside the temperature range specified in sections 2.4.5 and 5.1 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can get in contact with any of the electronic
components or wiring. Should the user suspect fluids have been in contact with system components or
accessories, the unit should not be used until deemed safe by an authorized service technician.

VRA201 - Instructions for Use - EN Page 6
Do not place the instrument next to a heat source of any kind, and allow enough space around the
instrument to ensure proper ventilation.
Electrical and electrostatic safety
Do not modify this equipment without authorization from Interacoustics. Do not disassemble or modify
the product as this may impact the safety and/or performance of the device. Limit servicing to qualified
personnel.
For maximum electrical safety, turn off the power when it is left unused.
The power plug must be placed so it is easy to pull out the plug.
Do not use any additional multiple socket-outlet or extension cord. For safe setup, please refer to
section 3.1.2.
Do not use the equipment if it is showing visible signs of damage.
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.
Electromagnetic compatibility (EMC)
NOTICE
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 and cables other than specified, apart from cables sold by Interacoustics or
representatives, may result in increased emission or decreased immunity of the equipment. For a list of
accessories that fulfil the requirements, please refer to the appendix regarding EMC.
Miscellaneous
Please note:
Storage in temperatures below 0°C /32°F and above 50°C /122°F may cause permanent damage to the
instrument and its accessories.

VRA201 - Instructions for Use - EN Page 7
Do not place the instrument next to a heat source of any kind. Within the European
Union, it is illegal to dispose of electrical and electronic waste as unsorted municipal
waste. Electrical and electronic waste may contain hazardous substances and therefore
must be disposed of separately. Such products will be marked with the crossed-out
wheelie-bin image shown to the left. User cooperation is important in order to ensure a
high level of reuse and recycling of electrical and electronic waste. Failure 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 its end
of life.
Use of equipment after transport and storage
Please make sure that the instrument is functioning correctly before use. If the instrument has been stored in
a cold environment (even for a short period of time), please allow the instrument to become acclimatized.
This can take long time depending on the conditions (such as environmental humidity). You can reduce the
condensation by storing the instrument in its original packaging. If the instrument is stored under warmer
conditions than the actual use conditions, no special precaution is required before use.

VRA201 - Instructions for Use - EN Page 8

VRA201 - Instructions for Use - EN Page 9
3Operating instructions
3.1 How to operate VRA201
Connect the medically approved power supply and the patient response to the VRA201.
The toy and light are controlled manually by the means of the activator button. The speed of the toy can be
adjusted by the means of a potentiometer on the rear panel.
3.2 Connection panel dictionary
Name
Description
Power
Only use power supply UES24LCP-120200SPA
Activator
Patient response used to activate the visual reinforcement
Intensity
Speed of the toy animal
3.3 Safety precautions when connecting the VRA201
Only use power supply UES24LCP-120200SPA.
The separable mains plug for UES24LCP-120200SPA 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.
Fig 1. VRA201 used with the medically approved power supply.
IN 12V=
/2.0A
Intensity
Activator
WARNING
WARNING

VRA201 - Instructions for Use - EN Page 10

VRA201 - Instructions for Use - EN Page 11
4Maintenance
4.1 General maintenance procedures
•Before cleaning, always switch off and disconnect from the power supply
•Use a soft cloth lightly dampened with a cleaning solution to clean all exposed surfaces
•Do not autoclave, sterilize or immerse the instrument or accessory in any fluid
•Do not use hard or pointed objects to clean any part of the instrument or accessory
•Do not let parts that have been in contact with fluids dry before cleaning
Recommended cleaning and disinfection solutions:
•Warm water with mild, non-abrasive cleaning solution (soap)
•70% isopropyl alcohol only on hard cover surfaces
4.2 Repair
Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety,
reliability and performance of the equipment if:
1. assembly operations, extensions, readjustments, modifications or repairs are carried out by
authorized persons
2. the electrical installation of the relevant room complies with the appropriate requirements, and
3. the equipment is used by authorized personnel in accordance with the documentation supplied by
Interacoustics.
It is important that the customer (distributor) fills out the RETURN REPORT every time a problem arises and
sends it to
DGS Diagnostics Sp. z o.o.
ul. Sloneczny Sad 4d
72-002 Doluje
Polska
This should also be done every time an instrument is returned to Interacoustics. (This of course also applies
in the unlikely worst-case scenario of death or serious injury to a patient or user).
4.3 Warranty
Interacoustics guarantees that:
•The Interacoustics VRA201 is free from defects in material and workmanship under normal use
and service for a period of 24 months from the date of delivery by Interacoustics to the first
purchaser
•Accessories are free from defects in material and workmanship under normal use and service for
a period of ninety (90) days from the date of delivery by Interacoustics to the first purchaser
If any product requires service during the applicable warranty period, the purchaser should communicate
directly with the local Interacoustics service center to determine the appropriate repair facility. Repair or
replacement will be carried out at Interacoustics’ expense, subject to the terms of this warranty. The product
requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in
return shipment to Interacoustics shall be at the purchaser's risk.

VRA201 - Instructions for Use - EN Page 12
This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or
holder of the product. Furthermore, this warranty shall not apply to, and Interacoustics shall not be
responsible for, any loss arising in connection with the purchase or use of any Interacoustics product that
has been:
•repaired by anyone other than an authorized Interacoustics service representative;
•altered in any way so as, in Interacoustics opinion, to affect its stability or reliability;
•subject to misuse or negligence or accident, or that has had the serial or lot number altered;
defaced or removed; or
•improperly maintained or used in any manner other than in accordance with the instructions
provided by Interacoustics.
In no event shall Interacoustics be liable for any incidental, indirect or consequential damages in connection
with the purchase or use of any Interacoustics product.
This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of
Interacoustics. Interacoustics does not give or grant, directly or indirectly, the authority to any representative
or other person to assume on behalf of Interacoustics any other liability in connection with the sale of
Interacoustics products.
INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION.

VRA201 - Instructions for Use - EN Page 13
5General technical specification
5.1 VRA – technical specifications
General
Standards:
Safety (power supply):
IEC 60601-1:2012
EMC:
IEC 60601-1-2:2014
Operation
environment:
Temperature:
15-35 °C
Relative humidity:
30-90%
Transport &
storage:
Storage temperature:
Transport temperature:
Rel. humidity:
0°C-50°C
-20-50 °C
10-95%
Power supply UES24LCP-
120200SPA
Only use specified power supply unit type
Input: 100-240VAC 50/60 Hz, 500mA
Output: 12.0 VDC 2.0A
Dimensions
H x W x L
D28 x W30 x H40 cm (11x12x16 inches)
VRA201 weight
6.6 kg/14.7 lbs.
Light
Two LED strips of 8.5W total, 12 Vdc
Construction
Wooden (MDF) cabinet
5.2 General information about specifications
Interacoustics continuously strives to improve its products and their performance. Therefore, the
specifications can be subject to change without notice.
Enquiries about representatives and products may be sent to:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com

VRA201 - Instructions for Use - EN Page 14
5.3 Electromagnetic Compatibility (EMC)
•This VRA201 is suitable in hospital environments except for near active HF surgical equipment and RF
shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic
disturbance is high
•Use of this VRA201 adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this VRA201 and the other equipment should be
observed to verify that they are operating normally
•Use of accessories, transducers and cables other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation. The list of accessories, transducers and
cables can be found in this appendix.
•Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this VRA201, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result
in improper operation
To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use
only the following accessories:
Item
Manufacturer
Model
Patient response switch
Radioear
APS3
Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types
and cable lengths are as specified below:
Description
Length (m)
Screened (Yes/No)
Patient response switch
2.0
Yes
Guidance and manufacturer’s declaration - electromagnetic emissions
The VRA201 is intended for use in the electromagnetic environment specified below. The customer or the
user of the VRA201 should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The VRA201 uses RF energy only for its internal
function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The VRA201 is suitable for use in all commercial,
industrial, business, and residential environments.
Harmonic emissions
IEC 61000-3-2
Complies
Class A Category
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies