MedRx Avant Stealth User manual

INSTALLATION MANUAL

Contents
Getting to Know your AVANT™ Stealth Audiometer ......................................................
4
Transducers and Accessories ........................................................................................
5
Software Installation .......................................................................................................
7
Loading the Calibration ..................................................................................................
10
EMC Precautions ...........................................................................................................
11
Safety .............................................................................................................................
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 Stealth Audiometer
Top View Type 1A HF E Audiometer
Bottom View
The Avant Stealth Audiometer represents
a new era of ultra compact diagnostic
audiometry for your office. Compact yet
rugged, this PC-Based system is USB or
external powered* and performs all
required ANSI and IEC audiometric tests.
The following section of this manual will
familiarize you with the physical features
and accessories of the system.
The Avant Stealth complies with the
requirements of: ANSI S3.6-2010, IEC
60645-1:2012, IEC 60645-2:1993 and
IEC 60645-4:1994.
*External Power is required to utilize the built-in
2x20 Watt Amplifiers and the Optional High
Frequency Feature. (See safety page for power
supply specification).
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Transducers and Accessories
3A Insert Earphones TDH-39 or DD45 Earphones HDA200 (Optional)*
High Frequency
NOTE: The Avant Stealth Audiometer supports 3A Insert earphones, TDH-39 or DD45 earphones and HDA200 extended high
frequency earphones. The standard configuration includes either 3A or TDH-39/DD45 earphones.
* HDA200 earphones must be ordered with the High Frequency Option Upgrade.
Operator Mic and Monitor Speakers (Optional) Bone Conductor
Power Supply
USB Cable
Patient Response Switch
Talkback Microphone
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The AVANT Stealth may be located inside or outside of a sound booth.
Refer to the Certificate of Calibration for transducer characteristics and the date of the next required
transducer calibration. Only transducers supplied by MedRx and specifically calibrated for each AVANT
Stealth Audiometer should be used.
There are two sets of air conduction transducer connections, AC-1 and AC-2 and two Operator Microphone
connections 1 and 2.
* High frequency transducers, such as HDA200, can be plugged to either AC-1 or AC-2 output.
* Either amplified or non-amplified speakers can be used. Amplified speakers are connected to the
Free Field (Line-Out) output. Non-amplified speakers are connected to the Free Field Loudspeaker outputs.
Make sure that the correct transducers are set in the software by right-clicking any transducer button on the
Audiometry screen and left-clicking to change the transducer.
*External power is required for non-amplified speakers and high frequency audiometry.
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Software Installation
1. Insert the AVANT TM Audiometer
CD-ROM into the CD drive. Wait until
the Setup program starts.
If Setup does not start automatically,
press Win+R on the keyboard, in the
box type D:\setup.exe (where D is
the letter of your CD-ROM drive),
and press Enter.
2. On the Setup screen, choose
Install Avant Stealth Audiometer.
3. This is the Welcome screen.
• To continue, click Next.
4. Read the Software License Agreement.
This important document defines the
acceptable usage of the AVANT Stealth
Audiometer.
• After reading the Agreement, choose
the Accept option and click Next.
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5. This screen indicates the software language
of the program. Choose the appropriate
language option.
• To continue with the default settings,
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.
7. This screen summarizes the installation
configuration.
•To continue, click Install.
•To make changes, click Back.
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8. When the installation is complete, click
Finish.
The Installation is finished.
Drivers are not required with the Stealth.
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Loading the Calibration
Each Avant Stealth Audiometer is calibrated
in compliance with the ANSI S3.6 standard.
This calibration procedure results in
accessing a series of files that the software
reads to keep the hardware in calibration.
These files are supplied on a CD bearing the
same serial number as your device.
The final step before using your Avant to
evaluate hearing is to load these device-
specific calibration files onto the computer
used to control the device.
1. Depending on your computer settings
you may see this screen
•Click the X to close out of this
window.
2. With the Calibration CD in the drive,
open the Avant software and click:
•Function
•Calibrate
•Load Calibration
3. After a few seconds, the CD will “spin
up” and this message will appear.
•Click Load.
4. When the files are finished being
loaded, this message will appear.
•Click OK to complete loading
the calibration.
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EMC Precautions
The Avant Stealth Audiometer 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 from transducers and accessories:
Transducer / Accessories
Maximum Cable length
Power Cord
2,0 meters
USB Cable
2,0 meters
All Transducers
2,0 meters
Monitor Headset
2,0 meters
Patient Microphone
2,0 meters
Patient switch
2,0 meters
Warnings!
•The Avant Stealth Audiometer generates high frequency for its own use.
•The Avant Stealth Audiometer is intended to create a medical system.
•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 Stealth Audiometer as replacement
parts for internal components, may result in increased emissions or decreased immunity of the
Avant Stealth Audiometer.
•The Avant Stealth Audiometer should not be used adjacent to or stacked with other equipment
and if adjacent or stacked use is necessary, the Avant Stealth Audiometer should be observed to
verify normal operation in the configuration in which it will be used.
•The Avant Stealth Audiometer may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.
•The Avant Stealth Audiometer does not have life supporting function.
•Portable and mobile RF communications equipment can affect the Avant Stealth Audiometer.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Avant Stealth Audiometer is intended for use in electromagnetic environment specific below. The customer or the
user of the Avant Stealth Audiometer should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Avant Stealth Audiometer 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 Stealth Audiometer 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.
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Harmonic emissions
IEC 61000-3-2
Class 1.Not applicable
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Passed
Guidance and manufacturer’s declaration – electromagnetic immunity
The Avant Stealth Audiometer is intended for use in electromagnetic environment specific below. The customer or the
user of the Avant Stealth Audiometer 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.
Surge
IEC 61000-4-5
+/- 1 kV
differential mode
+/- 2 kV
common mode
+/- 1 kV
differential mode
+/- 2 kV
common mode
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
< 5 % U
T
(> 95 % dip in UT)
for ½ cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
passed
passed
passed
passed criteria B
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the Avant Stealth
Audiometer requires
continued operation during
power main interruptions, it
is recommended that the
Avant Stealth Audiometer be
powered from an
uninterruptible power supply
or a battery.
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(> 95 % dip in U
T
) for 5 s
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.
NOTE U
T
is the a.c. mains voltage prior to application of the test level
Guidance and manufacturer’s declaration – electromagnetic immunity
The Avant Stealth Audiometer is intended for use in electromagnetic environment specific below. The customer or the
user of the Avant Stealth Audiometer 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
Stealth Audiometer, 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
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.
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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 abso
rption 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 Stealth Audiometer
is used exceeds the applicable RF compliance level above, the Avant Stealth Audiometer should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Avant Stealth Audiometer.
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 Stealth Audiometer
The Avant Stealth Audiometer is intended to use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Avant Stealth Audiometer can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Avant Stealth Audiometer 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 to be used only by professionals in the hearing
healthcare industry. This audiometer conforms to the requirements of IEC 60601-1.
It is Class II Medical Electrical (ME) equipment that is part of an ME system.
Power is supplied by an un-grounded mains power cable to a medical grade power supply, and
by the USB connection to a computer. A medical grade computer is recommended and a medical
grade isolation transformer will help minimize ground current. The use environment should be
between 10°C and 35°C, humidity within 30% to 90%, ambient pressure of 1013 +/- 10% mbar.
All components with patient contact are made of bio-compatible materials. The IP code is IP22.
The colored lights on the device only signify that the device is operational. The color does not
signify any dangerous or faulty condition. Mild soapy water or 70% isopropyl alcohol are the
preferred cleaning solutions.
Maximum warm-up time needed is 5 minutes.
Use only the 15 VDC, 2A medical power supply supplied with your Avant Stealth: ETMA150200UD-P5P-IC.
Mains power 100 – 240 VAC 50/60 Hz. The operator should periodically inspect the power supply and
cables for any signs of wear or damage. Contact MedRx for replacement parts.
The power supply cable should always be accessible in order to disconnect it from the supply mains.
All repairs should be sent to MedRx for evaluation and / or repair.
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.
Manufacturer (MedRx).
Authorized Representative in Europe.
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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 (888)
392-1234 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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