MedRx Avant A2D+ User manual

INSTALLATION MANUAL
www.medrx-usa.com

Contents
Getting to Know Your AVANT A2D+........................................................................................
3
Transducers.............................................................................................................................
4
Software Installation ................................................................................................................
5
Loading Calibration Files .........................................................................................................
9
EMC Precautions.....................................................................................................................
10
Safety ......................................................................................................................................
13
Cleaning .................................................................................................................................
15
Limited Warranty .....................................................................................................................
16
#0086
www.medrx-usa.com
1200 Starkey Rd., #105, Largo FL 33771 U.S.A.
Toll Free: [phone] • [phone]
Fax: [phone] • Email: [e-mail]
MedRx's Authorized Representative in Europe
(Regulatory affairs only)
Emergo Europe, Molenstraat 15
2513 BH The Hague, The Netherlands
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Getting to Know Your
AVANT A2D+ Audiometer
The AVANT A2D+ represents a new era of ultra compact diagnostic audiometry for your office.
Compact yet rugged, this PC-Based system is USB powered and supports ANSI and IEC audiometric
tests. The following section of this manual will familiarize you with the physical features and
accessories of the A2D+ system.
Unit Powered On – No Ear Selected Bottom View
A unique feature of the AVANT A2D+ Audiometer is the light panel which indicates which ear is
selected in the software. When the unit is powered up and no ear is selected, the light shines
green as shown above. During testing, the light shines blue when the left ear is selected and red
when the right is selected as shown below.
Patient Side View Operator Side View
Left Ear Selected
Right Ear Selected
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Transducers and Accessories
3A Insert Earphones Supra-Aural Headphones Bone Conductor
Talkback Microphone Patient Response Switch
Operator Mic and Monitor
(may vary)
USB Cable
Use the accessories provided with your Avant A2D+. Use of un-approved accessories is not recommended.
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Software Installation
Do Not Plug in the AVANT A2D+ USB Cable yet!
1. Insert the AVANT A2D+ Software Install
disk into the CD drive. Wait until the Setup
program starts.
•If the Setup program does not
automatically start:
•Press the “Win – R” keys on the
keyboard.
•Type D:\Setup.exe in the window
where ‘D’ is the drive letter assigned
to the CD ROM drive on your
computer.
•Press OK to start the Setup.
2. On the Setup screen, choose Install AVANT
A2D+ Audiometer.
NOTE: No MedRx driver installation is
required with the AVANT A2D+. (Windows 7
or 8 Professional 32/64 bit recommended)
3. This is the Welcome screen.
•To continue, Click Next.
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4. Read the Software License Agreement. This
important document defines the acceptable
usage of the A2D+ Audiometer software.
•After reading the Agreement,
•select “I accept …”
•click Next.
5. This screen sets the language and location
choice. Make a selection and click Next.
6. This screen indicates the location of the
program files. The default location is
recommended for most users. If necessary,
this location can be changed.
•To continue with the default settings, click
Next.
•To change the location of the files
(advanced users or system administrators
only, click Change).
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7. Installation of Program is ready to start.
•To continue, click Install.
•To make changes, click Back.
8. Installation is in process.
9. When the installation is complete, click Finish.
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Your AVANT A2D+ is USB powered.
Connect the USB cable from the AVANT A2D+ TM to your computer as shown below.
Wait for the system to copy and install default Windows drivers.
When this screen appears and all devices are “Ready to
use”, click Close.
Next you need to confirm or set the Default Windows sound card settings. This will route all non-AVANTTM
Windows sounds to the internal sound card of your computer. These sounds include event notifications
such as new e-mail and error warnings as well as audio and video playback.
Launch the AVANT A2D+software.
Open the Advanced Options from File menu as shown.
Open Audio tab.
When the audio properties are configured
properly, during driver installation, the Audio
Tab will appear like the image on the left. If not,
use the pull-down lists to adjust the settings to
match the image.
Click Audio Properties.
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In Windows Sound control panel, make sure
the MedRx Audio Device is not set as default.
If it is default, change this by clicking on your
system (non-MedRx) audio device and then
choose Set Default.
NOTE: The internal sound card on your
computer will likely not have the same name as
this screen shot. Consult your computer’s
documentation for the name of the internal
sound card and set this control accordingly.
Click OK.
Loading Calibration Files
Each AVANT A2D+ audiometer is calibrated in
compliance with the ANSI S3.6 standard. This
calibration procedure results in a series of files
that the A2D+ software reads to keep the
hardware in calibration. These files are supplied
on a CD bearing the same serial number as your
A2D+ device.
The final step before using your AVANT A2D+ to
evaluate hearing is to load these device-specific
calibration files onto the computer used to
operate the A2D+ device.
1. With the Calibration CD in the drive, open
the AVANT A2D+software and click:
•Function.
•Calibrate.
•Load Calibration.
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2. After a few seconds, the CD will “spin up”
and this message will appear.
•Click Load.
3. When the files are finished being loaded,
this message will appear:
•Click YES to complete loading the
calibration.
EMC Precautions
The Avant A2D+ needs special precautions regarding EMC and needs to be installed
and put into service according to the following EMC information.
List of all cables and maximum lengths of cables, transducers and accessories:
Transducer / Accessories
Maximum Cable length
USB Cable
3 meters
Insert Earphones
2 meters
All Headsets
2 meters
All Microphones
2 meters
Warnings!
•The use of accessories, transducers and cables other than those specified, with
the exception of transducers and cables sold by the manufacturer of the Avant
A2D+ as replacement parts for internal components, may result in increased
emissions or decreased immunity of the Avant A2D+.
•The Avant A2D+ should not be used adjacent to or stacked with other equipment
and if adjacent or stacked use is necessary, the Avant A2D+ should be observed
to verify normal operation in the configuration in which it will be used.
•The Avant A2D+ may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.
•The Avant A2D+ does not have life supporting function
•Portable and mobile RF communications equipment can affect the Avant A2D+.
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Guidance and manufacturer’s declaration – electromagnetic emissions
The Avant A2D+ is intended for use in electromagnetic environment specific below. The customer or the user of the
Avant A2D+ should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Avant A2D+ 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 Avant A2D+ is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low - voltage power supply network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Non applicable
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Non applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
The Avant A2D+ is intended for use in electromagnetic environment specific below. The customer or the user of the
Avant A2D+ should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast transient /
burst
IEC 61000-4-4
+/- 2 kV for power supply
lines
+/- 1 kV for input / output
lines
+/- 2 kV for power supply
lines
+/- 1 kV for input / output
lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
Power frequency (50/60 Hz)
Magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Avant A2D+ is intended for use in electromagnetic environment specific below. The customer or the user of the
Avant A2D+ should assure that it is used in such an environment.
Immunity test
IEC 60601- test level
Compliance level
Electromagnetic environment -
guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the Avant
A2D+, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 Veff 3 Veff
d = 1,17
P×
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
d = 1,17
P×
80 to 800 MHz
d = 2,33
P×
800 MHz to 2,5 GHz
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Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a, should be
less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency ranges applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Avant A2D+ is used
exceeds the applicable RF compliance level above, the Avant A2D+ should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Avant A2D+.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
Portable and mobile RF communications equipment and the Avant A2D+
The Avant A2D+ is intended to use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Avant A2D+ can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the Avant A2D+
as recommended below, according to the maximum output power of the communications equipment.
Rated
maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
meters
150 kHz to 80 MHz
d = 1,17
P×
80 MHz to 800 MHz
d = 1,17
P×
800 MHz to 2,5 GHz
d = 2,33
P×
0,01
0,12
0,12
0,233
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,7
3,7
7,40
100
11,7
11,7
23,3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
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Safety
•Regarding electrical safety, this device is designed to be used only by
professionals in the hearing healthcare industry.
•It is Class II Medical Electrical (ME) equipment that is part of an ME system.
This device provides Type B protection (Type B equipment,
Type B applied part)
•This device is not protected from ingress of water. The water protection level is
IP21.
•Power is supplied by the USB cable connected to a computer.
•A USB Optical Isolator, with a minimum of 1000 DC volt isolation, should be
placed in-line between the computer’s USB connection and the MedRx device.
The Optical Isolator should be powered by a power supply that conforms to IEC
60601-1. The computer, Optical Isolator’s power supply and the speaker’s power
supply should be connected to the Medical Grade isolation transformer that
conforms to IEC 60601-1. Follow the manufacturer’s instructions for installation
and use.
•The computer used with this device should conform to the requirements of IEC
60950-1 and IEC 60601-1-4.
•A MULTIPLE PORTABLE SOCKET-OUTLET or extension cord shall not be
connected to the system.
•The device warm-up time is less than 2 minutes.
•Do not connect items that are not specified as part of the system.
•The use environment should be between 10°C and 35°C , humidity
within 30% to 90% and an atmospheric pressure range from 80 kPa
to 104 kPa.
•Storage temperature range at least from 0°C to 50°C
•All components with patient contact are made of bio-compatible materials.
•This device does not produce any adverse physiological effects.
•Install the device as directed by this manual to achieve optimal use. Clean
accessories per the cleaning instructions prior to use. No Sterilization is required
for components of this device. However, new foam inserts are needed for each
patient where applicable and cleaning of the device and accessories should follow
the procedure outlined below.
•The device is not intended to be operated in an environment with anesthetics,
oxygen or NO. It is not an AP or APG device. This ME System is not intended
for use with flammable anesthetics.
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•This device uses Type B application parts temporarily placed on the patient
during testing. They are nonconductive and can be immediately withdrawn from
the patient at any time.
•The device is intended for continuous operation.
•The computer and the MedRx device or accessories may be located in the patient
environment if required.
•The colored lights are as designated by ANSI S 3.6 and IEC 60645-1. They
signify that either the left (blue) channel is active or the right (red) channel is
active, or no channel is active (green). The colors do not signify any dangerous or
faulty condition.
•Contact the local MedRx distributor for safe and proper disposal of this
equipment. Proper disposal may require that it be sent to collection
facilities for recovery and recycling.
•All repairs should be sent to MedRx for evaluation and / or repair. However,
necessary diagrams and repair instruction will upon request be provided to
authorized repair personnel.
•There are no known contraindications for the use of this equipment.
Symbols that may be used:
Read the instruction manuals for
safe usage of the device. (operating
instructions)
or SN Indicates that the
device serial number will follow.
Type B applied part. (Type B
equipment)
Manufacturer (MedRx)
Authorized Representative in
Europe
Non-ionizing
electromagnetic radiation
Special Disposal Required.
Humidity Limitation
Caution, General
warning sign
Temperature limitation
Read the instruction
manuals for safe usage of the device
(operating instructions).
Class II equipment
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Start (of action)
Stop (of action)
Percentile Setup
Calibration
Loudspeaker (Speaker)
Headphones
Handheld microphone
(Talkback Microphone)
Recording
Microphone
Recommended Procedures for Cleaning and Disinfection
1. Foam ear tips are single use components, and should not be re-used by another patient.
2. It is recommended that 70% Isopropyl Alcohol should be applied to a soft clean cloth or
tissue, not directly on the component to be cleaned. The cloth should never be wet, just
damp. A mild soapy water solution is an alternative cleaning liquid.
3. To ensure that cross contamination does not occur, use clean cloth or sealed Alcohol swabs
for each device to be cleaned.
4. Wipe the surfaces of the Operator headset and headphone pads with the 70% Isopropyl
Alcohol. Clean other transducers in the same way. Do not let 70% Isopropyl Alcohol or water
enter the microphone sound inlet.
5. The white device housing may also be wiped with 70% Isopropyl Alcohol. The speaker
controls, headphone ear pads, head band and other components may be cleaned in a similar
way.
6. Let all components that have been cleaned, thoroughly dry before use.
7. Cleaning of the computer should be performed using the methods suggested in the
computer’s manual.
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Congratulations
Your MedRx system is now set up and ready for use. Please consult the
Training Manual and the Interactive Help Files within the software for instructions
and procedures. The Training Manual is available in PDF format on CD and at
www.medrx-usa.com in our Download Section.
Limited Warranty
MedRx, Inc warrants this product to be free from defects in material and
workmanship for one year from the time of purchase. If this system fails to perform
as specified during this period, the purchaser is responsible for calling MedRx at
[phone] or [phone]. The company's representative will advise the
owner to either return specific components or the entire system to:
MedRx, Inc.
1200 Starkey Road #105
Largo, FL 33771 USA
MedRx will repair or replace any defective devices, fully test the system and/or
components and ship the system promptly back to the owner. There is no cost for the
repair or return shipping, provided the system is one year old or less and has not
been misused, abused or damaged. Such damage includes, but is not limited to,
dropping, exposure to excessive heat greater than 100ºF and water/liquid damage.
Repair or replacement of the system as provided under this warranty is the sole and
exclusive remedy of the purchaser. MedRx shall not be liable for any consequential
or incidental damages or for breach of any express or implied warranty. Except to the
extent of applicable law, any implied warranty, merchantability or fitness of this
product is limited to the duration of this warranty.
MedRx will, at its discretion, service and repair out of warranty products at the
purchaser's request, charging for parts and labor as necessary.
The limited warranty is deemed void if software or hardware is installed on this
product which is not pre-approved by MedRx, Inc. Approved software includes
NOAH™and HIMSA approved hearing aid manufacturer programming modules for
fitting hearing aids.
MedRx, Inc is not responsible for problems resulting from installation of unapproved
software or hardware. In the event of unapproved software or hardware installed on
the system causing a conflict, MedRx will service the product for a fee to be
determined at the time of service.
Any extension of this warranty past the initial one-year warranty is subject to the
following (where applicable).
1. A $300 deductible per repair.
2. Extended warranty does not include cables, connectors or peripherals.
3. Extended warranty of the Video Otoscope covers optics only.
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