Oasis™ User Manual - Neuromonics Professional

Oasis™ User Manual - Neuromonics Professional
Oasis™ User Manual
2
Manufactured and marketed by:
United States:
Neuromonics Inc.
8774 Yates Dr. Unit 220
Westminster, CO 80031
Toll Free: +1-866-606-3876
www.neuromonics.com
Product protected by patents 778093 (Australia), 2004294229
(Australia), 2007254667 (Australia). 2,368,045 (Canada),
ZL200480041291.3 (China), ZL200410088176.3 (China),
ZL00807081.4 (China), HK1077189 (Hong Kong), 249,46
(India), 4249908 (Japan), 514,889 (New Zealand), 529,257
(New Zealand), 551,980 (New Zealand), 83502 (Singapore),
6,682,472 (USA), 7,520,851 (USA), 7,736,297 (USA), 7,850,596
(USA) and 7,854,697 (USA). Other patents pending, including
Publication No. 2011/0137111 (USA).
Neuromonics is a trademark of Neuromonics Pty Ltd and Inc.
© Copyright 2012 Neuromonics Pty Ltd and Inc.
DOC No: 002-0056N Rev. 2
3
TABLE OF CONTENTS
USER ASSISTANCE INFORMATION .................................... 7
CLINICIAN NAME AND CONTACT INFORMATION ... 7
CLASSIFICATION ......................................................................... 8
SYMBOLS ......................................................................................... 9
ABBREVIATIONS ....................................................................... 10
BEFORE YOU BEGIN ............................................................... 11
FOR YOUR SAFETY .................................................................. 12
Warnings .................................................................................... 12
Precautions................................................................................. 13
INDICATIONS FOR USE ......................................................... 14
YOUR OASIS DEVICE .............................................................. 15
Components Checklist ............................................................. 16
USING THE OASIS DEVICE .................................................. 16
When To Use ............................................................................ 16
How Long To Use .................................................................... 17
How To Listen .......................................................................... 17
Tips for Use ............................................................................... 17
OPERATING THE OASIS DEVICE ...................................... 18
Powering On the Oasis device ............................................... 18
Connecting the Headphones................................................... 18
4
Beginning and Ending a Session ............................................ 19
Setting the Volume ................................................................... 20
Selecting a Track ....................................................................... 22
CHARGING THE OASIS DEVICE ........................................ 24
DATE AND TIME ....................................................................... 26
Setting the Date and Time ....................................................... 26
Checking Date and Time ......................................................... 26
ADDITIONAL FEATURES ...................................................... 27
Sleep Timer ................................................................................ 27
Single/Continuous Mode ........................................................ 27
Progressive Muscle Relaxation Track .................................... 28
CARE AND MAINTENANCE ................................................. 29
The Oasis Device ...................................................................... 29
Headphones ............................................................................... 29
SERVICE AND REPAIR ............................................................ 30
TROUBLESHOOTING .............................................................. 31
SPECIFICATIONS ....................................................................... 32
Physical Specifications ............................................................. 32
Dimensions ................................................................................ 32
Weight......................................................................................... 32
Functional Specifications ......................................................... 32
5
Power Specifications ................................................................ 32
Environmental Specifications ................................................. 32
Operating Conditions ............................................................... 32
Storage Conditions ................................................................... 32
IEC 60601-1 General Requirements for Safety ................... 33
FCC COMPLIANCE STATEMENT ........................................ 33
LEGAL ............................................................................................ 34
Limited Warranty ...................................................................... 34
Product Warranty Period ......................................................... 34
LIST OF FIGURES
Figure 1 – Oasis device ........................................................ 15
Figure 2 – Connecting Headphones to The Oasis device
.................................................................................................. 19
Figure 3 – Select A Particular Track Using << and >>
Buttons.................................................................................... 23
Figure 4 – Micro USB Charging Port (Located on Bottom
of the Oasis Device............................................................... 25 LIST OF TABLES
Table 1 – Troubleshooting ................................................. 31 6
Please read this manual carefully before using the Oasis device.
USER ASSISTANCE INFORMATION
Should you experience a problem with your Oasis device or
accessories, please contact your clinician.
CLINICIAN NAME AND CONTACT
INFORMATION
Name: ___________________________________________
Contact information: ________________________________
7
Classification
Equipment Function:
Degree of protection
against electrical shock:
Treatment of tinnitus
disturbance.
Type BF applied part.
Supply connection:
Internal rechargeable LiON
battery
Battery Charger:
5 VDC, 1 A
Mode of Operation:
Continuous
Degree of mobility:
Handheld
Classification:
Class II Internally Powered
CSA Canada and USA Safety
Testing :
IEC60601-1
8
SYMBOLS
Back
<<
Forward
>>
Up
+
Down
-
Consult instruction for use
(Consulter les instructions d'utilisation)
Caution (Attention)
CSA
Type BF applied part
(Partie appliquée de type F)
Double Insulation(Double Isolation)
Warning (Avertissement)
Temperature limits (Température limite)
Manufacturer (Manufacture)
Date of Manufacturer (Date de Manufacture)
9
ABBREVIATIONS
A
Amperes
DC
Direct Current
F
Fahrenheit
FCC
Federal Communications
Commission
Hz
Hertz
MRI
Magnetic Resonance Imaging
SN
Serial Number
USB
Universal Serial Bus
V
Volts
VAC
Volts Alternating Current
VDC
Volts Direct Current
10
BEFORE YOU BEGIN
You are now ready to start using your Neuromonics Oasis at
home and at work in specific situations that are impacted by
your tinnitus. This User Manual will help you set up and use
your Oasis device.
The Oasis device has been designed to help you treat your
tinnitus. There are four tracks that have been prescribed as part
of your tinnitus treatment program. Your clinician has
explained how to use the Oasis device, also as part of your
tinnitus treatment program. When used as part of this
protocol, individuals with tinnitus typically experience:
1. Relief from their tinnitus while using the Oasis device;
2. A gradual feeling of control over the tinnitus as the
lifestyle effects of tinnitus are overcome.
3. 3. A gradual reduction (over several months) in the
disturbance of tinnitus between listening sessions.
This manual is designed as a guide to help you remember what
you and your clinician discussed. This manual discusses:
•
•
•
Using the Oasis device
Operating the Oasis device
Charging the Oasis device
11
FOR YOUR SAFETY
Warnings
•
•
•
•
•
•
•
•
12
Federal US law restricts this device to sale by, or on the
order of, a qualified clinician.
The Oasis device may be affected by portable and
mobile radio frequency communications equipment.
Use only the Neuromonics battery charger provided.
Other chargers may not provide adequate protection
against electrical shock.
This equipment is not suitable for use in the presence of
a flammable anesthetic mixture with air or with oxygen
or nitrous oxide.
Permanent hearing loss may occur if the Oasis device is
used at a high volume.
If set to the maximum output level and worn for periods
of time exceeding four (4) hours a day, your exposure to
sound energy has the potential to exceed noise exposure
limits.
To avoid shock or injury, do not use the Oasis device in
or near water or wet locations.
Avoid using the Oasis device while driving, cycling or
while performing any other activity that requires your
full attention.
•
•
•
The battery used in this device may present a chemical
burn or fire hazard if mistreated. Do not disassemble,
heat above 130°F (55°C) or incinerate.
The Oasis device has been certified to be protected to
emissions and immunity according to IEC-60601-1-2.
Consult your clinician if you are concerned at any time
about your tinnitus getting worse or if you believe you
have any other side effects from the Oasis device.
Precautions
•
•
•
•
•
•
Avoid using the Oasis device in areas that are extremely
hot or cold, dusty or humid.
Store the Oasis device carefully and keep it away from
high humidity and strong magnetic fields (e.g. Magnetic
Resonance Imaging [MRI]).
Take care when handling the Oasis device, as incorrect
handling or dropping the Oasis device may cause
damage.
The Oasis device can be used when the battery is being
charged as long the supplied battery charger is used.
Remove hearing aid, if applicable, before using the Oasis
device.
Use only the headphones supplied with your Oasis
device. Other headphones may not transmit the
13
•
•
•
•
•
•
•
prescribed sounds that are essential for effective
treatment with the device.
If the sounds you hear seem to be unbalanced or
uncorrelated, there may be something wrong with the
headphones. See the section “Setting the volume” for
instructions.
Do not adjust the volume during sessions so that the
music is uncomfortably loud. Contact your
Neuromonics clinician if you are unable to set your
device at a comfortable listening volume.
Do not bend or crush the headphone wires or
connector.
Do not attempt to repair the Oasis device yourself. This
may cause harm to you and voids the limited warranty.
Only use accessories with your Oasis device that are
supplied through Neuromonics.
Use only the battery charger provided. Other chargers
may look similar but may cause damage to your Oasis
device.
Take care not to apply excessive pressure or deform the
device.
INDICATIONS FOR USE
The Oasis device is intended for the treatment of adult patients
with tinnitus that have been assessed by, and are under the
supervision of a qualified clinician.
14
YOUR OASIS DEVICE
Your Oasis device uses buttons to navigate through the menu
structure and through sound files. Figure 1 shows a
representative image of the Oasis device.
Figure 1. Oasis device
15
Components Checklist
The following items are packaged with the Oasis device:
•
•
•
•
•
•
Oasis device
Headphones
Battery charger and micro Universal Serial Bus (USB)
cable
User Manual
Neuromonics Tinnitus Management Handbook
Warranty Registration Card
USING THE OASIS DEVICE
When To Use
You can use the Oasis device at any time—day or night. It is
recommended that you listen to your Oasis device 2-4 hours
each day, and specifically when you find your tinnitus
disturbing. You may want to use your Oasis device when you
are relaxing, contemplating or performing quiet tasks. The
tracks have been specially selected to maximize your relaxation
response, but not to be too distracting. The Oasis device can
also aid the onset of sleep and help you get a good night’s rest.
For bedtime use, the Oasis device can be set to turn off
automatically (for details, see “Selecting a Track”).
Once the tracks have been heard a few times, the music tends
to fade into the background of your consciousness. It may help
you concentrate while reading, writing or using a computer.
16
How Long To Use
We recommend you use your Oasis between 2 to 4 hours each
day. The guiding principle is to use your Oasis device
whenever the tinnitus is disturbing you in order to condition a
relaxation response to your tinnitus perception. If your tinnitus
is disturbing for more than 4 hours each day, then additional
usage is acceptable.
How To Listen
It is best not to consciously listen during a session. Set the
volume appropriately (for details, see “Setting the Volume”)
when you begin a listening session, then try to place the music
in the background of your awareness. This becomes easier as
you become familiar with the tracks.
Once you have set the volume at the beginning of a session, try
to avoid "tuning in" to your tinnitus.
Tips for Use
•
•
•
Your Oasis device is small, light and designed to fit in a
pocket or bag.
If you need help with your sleep, use your Oasis device
at bedtime.
A number of conditions may temporarily make your
tinnitus perception worse: colds or flu, excessive caffeine
intake, medication, excessive noise (for example at a
party), straining to hear quiet speech, and periods when
you are highly stressed. At such times, you may need to
increase the volume level of treatment to achieve the
17
required level of interaction (blending) with your tinnitus
perception. However you should avoid using any volume
level that prevents the sound from always being
comfortable, pleasant, and relaxing.
OPERATING THE OASIS DEVICE
Powering On the Oasis device
If the Oasis device is powered off, press down the middle
button. The Oasis device powers on to the Menu screen.
Connecting the Headphones
The sounds played by your Oasis have been exactly matched to
the spectral profile of the supplied headphones to ensure your
device usage is effective. Additional headphone options are
available for purchase through your clinician. Headphones
other than those prescribed by your clinician for use with the
Oasis device are not designed to deliver the appropriate
acoustic stimulus.
Plug the supplied headphones into the headphone port on the
top of the Oasis device, shown in Figure 2.
18
Figure 2. Connecting Headphones to tThe Oasis device
Beginning and Ending a Session
There are four Neuromonics customized music tracks that
have been programmed for your listening sessions. For more
details, see “Selecting a Track.”
To play a track:
1. Press the center Play button. The first track starts to
play.
2. Press Play again to pause treatment.
3. To skip between tracks, press the << or >> button.
When you press play again, play resumes from the point where
the track paused. If the device remains paused for five minutes,
the device shuts off. If play is pressed again while off, the
Oasis device starts over by playing the first track.
19
Setting the Volume
Do not adjust the volume during sessions so
that it is uncomfortably loud. It is important
to always listen at a comfortable level, even if
you are still able to hear your tinnitus.
Each time you press PLAY at the start of a session, the volume
starts at a minimum volume level. This is so that you set the
volume to the correct level each time you listen to your Oasis
device.
•
20
The Oasis device is designed to replace the unpleasant
sound of the tinnitus with a pleasant external sound.
Set the volume at a level that is comfortable, but
provides as much relief from the tinnitus as possible.
Don’t be afraid to use more volume if you need it for
relief however, the treatment always needs to be
pleasant and relaxing. Listening at higher volumes can
take away from the relaxing aspects and can become
frustrating.
During musical quiet periods, you may notice a pleasant
background noise. This has been added to provide a high level
of interaction with your tinnitus. At other times, depending on
the phase of treatment, this sound may not be present.
It is important to set the volume only when you initially switch
on the Oasis device. Do not adjust the volume again during the
session unless it becomes uncomfortably loud.
If the sounds you hear seem to be unbalanced
or uncorrelated, there may be something
wrong with the headphones. Check that you
have placed them in the correct ears. Also
check that they are both working by listening
to one at a time. If you feel there is a problem
with the headphones, please contact your
clinician.
21
To adjust the volume:
1. Press the +/- buttons on the Oasis device. See Figure 1.
Each time you press a button, the volume increases or
decreases incrementally.
2. Press the desired button until you reach a volume
comfortable for you.
Selecting a Track
Each of the four music tracks lasts for approximately 60
minutes. You may prefer to listen to a variety of track or to a
single track several times. You may find some tracks are more
appropriate for certain listening times, for example when you
are going to sleep or when you are working.
To select a particular track, press the << or >> buttons.
Repeat until you reach the desired track, indicated on the Oasis
device screen. See Figure 3.
22
Back
Forward
Figure 3. Select A Particular Track Using << and >> Buttons
•
•
If you select SINGLE mode, the selected track plays
through once, then fades out and ends. You may wish to
use the SINGLE setting when using the Oasis device to
help fall asleep.
If you select CONTINUOUS mode, the entire track list
plays continuously until you press Play/Pause or turn off
the Oasis device. For example, track 2 follows track 1,
Track 3 follows track 2, and so on. When track 4
finishes, track 1 begins again, and the sequence
continues.
23
CHARGING THE OASIS DEVICE
Use only the Neuromonics battery charger
provided. Other chargers may not provide
adequate protection against electrical shock
or may damage your device. The Oasis device
is supplied about halfway charged and should
be charged upon receipt.
It is recommended that you charge your
device daily.
When battery power is getting low, the battery indicator on the
screen starts to blink on and off while you are using the Oasis
device. You have a few hours of usage time from when the
battery indicator begins blinking. Following this, the device
stops playing and shuts down. You need to recharge your
device before you use it again. You can use the Oasis device
while it is being charged as long as you use the supplied battery
charger.
Use the battery charger provided. Other
chargers may look similar but may cause
damage to your Oasis device.
24
To charge the Oasis device:
1. Plug the supplied power cord into a power outlet.
2. Insert the charger plug into the Oasis device micro USB
charging port (Figure 4).
Bottom
Micro-USB
Port
Figure 4. Micro USB Charging Port (Located on Bottom of the
Oasis Device)
3. Plugging the charger into the device automatically starts
charging the Oasis device. You can verify this by viewing
the “Charge Battery” icon on the main screen. Battery
charging can take up to 10 hours. When charging is
complete, the batter icon fills in completely and the
normal charged icon will appear on the screen.
4. Disconnect the charger and unplug from the power
outlet.
25
DATE AND TIME
Setting the Date and Time
To set the date and time:
1. Press and hold the Play button until the set-up menu
appears (approx. 5 seconds).
2. Using the +/- buttons, scroll down until the Set
Date/Time Menu is highlighted.
3. Press the center Play button to access the Date/Time
Menu
4. In the Date field press the +/- keys until the desired
month is selected. By using the << and >> buttons, you
can move to the Day field and repeat step number 4 to
achieve the desired day.
5. Repeat step 4 to change the year.
6. To complete setting the time, return to the setup screen
by advancing to the “Setup Menu” item, and then press
the center button to return.
Note: The Oasis device will automatically return to the main
screen if no action is taken for approximately 30 seconds.
Checking Date and Time
The current date and time is displayed on your home screen.
26
ADDITIONAL FEATURES
Sleep Timer
The Oasis device comes with a sleep timer so that you can play
the Oasis device for 5 minutes up to 120 minutes.
To change the sleep timer:
1. Press and hold the center Play button for approximately
3 seconds to access the set-up menu.
2. To select the Sleep Timer Menu, press the << or >>
buttons until the Sleep Timer is highlighted. By pressing
the << or >> buttons, the Sleep Timer will change from
5 to 120 minutes.
3. Select the desired sleep time, then scroll down to return
to the Setup Menu.
Note: The Oasis device will automatically return to the main
screen if no action is taken for approximately 30 seconds.
Single/Continuous Mode
The Oasis device allows you to play your tracks in either a
continuous fashion or a single time only. When selecting
Continuous, the track sequence will repeat after the final track
and start at the beginning once more.
27
To Select Single or Continuous Mode:
1. Press and hold Play for approximately 5 seconds to
access the set-up menu.
2. Press the +/- buttons until the desired mode is
highlighted. Pressing the << or >> button changes the
mode from Single to Continuous.
3. Select the desired mode, then scroll down to return to
the Setup Menu.
Progressive Muscle Relaxation Track
Your Oasis device contains a selection that walks you through
the steps of a progressive muscle relaxation exercise. These
exercises can help you relax by teaching you to calm your
body when you feel anxious.
From the Utilities menu select “Play PRM”.
28
CARE AND MAINTENANCE
Avoid using The Oasis device in areas where
it is extremely hot or cold, dusty or humid.
Store The Oasis device carefully and keep it
away from high humidity and strong
magnetic fields (e.g. MRI).
Take care when handling the Oasis device, as
improper handling or dropping the device
may cause damage.
The Oasis Device
Clean only with a dry cloth.
Headphones
It is important to take good care of the headphones provided
with the Oasis device. They are high quality, high fidelity
headphones and have been chosen specifically because of their
superior acoustic performance characteristics. Together with
your customized Oasis device, these headphones ensure that
you receive the optimal acoustic stimulation for your tinnitus
treatment.
29
SERVICE AND REPAIR
Do not attempt to change the battery or open
the Oasis device for any reason. The battery
must be changed by Neuromonics. If you
open the Oasis device, you will void the
warranty.
There are no serviceable parts inside the Oasis device.
Refer all servicing to qualified Neuromonics service personnel.
Please contact your clinician to organize servicing as required.
30
TROUBLESHOOTING
Use Table 1 to troubleshoot your Oasis device.
Table 1. Troubleshooting
If
Then
the device will not
power on,
Charge the Oasis device (see the section
“Charging the Oasis device”). Keeping it
charged will ensure your device
continues to operate. Please note: there
will be approximately four hours of play
time available after the blinking light
begins. If it does not play after fully
charging, contact your clinician.
you hear the track
in one headphone
only,
Check that the headphones plug is
pushed firmly into the headphones port
on the top of the Oasis device (see
Figure 1). Make sure headphones are
inserted properly in each ear. If you still
cannot hear the track in both
headphones, please contact your
clinician.
the Oasis device
stops treatment
after one track,
Verify that the SINGLE /
CONTINUOUS setting is set to
SINGLE. Reset to CONTINUOUS (see
“Selecting a Track”).
31
SPECIFICATIONS
Physical Specifications
Dimensions: 3.9 x 2.4 x .7 in
Weight: 3.2 ounces
Functional Specifications
Power 3.6VDC, internally powered rechargeable LiON battery
Power Specifications
Battery charger input: input voltage 110–240 VAC
Input current: 0.3 amps
Input frequency: 50–60 Hz
Battery charger output: 5.0 VDC at 1 amp
Environmental Specifications
Operating Conditions
32° to 104°F (0° to 40°C)
Storage Conditions
-4° to 104°F (-20° to 40°C)
32
IEC 60601-1 General Requirements for Safety
Complies with:
•
•
IEC 60601-1 Electrical Safety
IEC 60601-1-2 Electromagnetic Compatibility
FCC COMPLIANCE STATEMENT
This equipment has been tested and found to comply with the
limits for a Class BF digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful
interference to radio communications. However, there is no
guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference
to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try
and correct the interference by one or more of the following
measures:
•
•
•
•
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and
receiver.
Connect the equipment into an outlet on a circuit
different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV
technician for help.
33
LEGAL
Limited Warranty
Neuromonics warrants that your Oasis device and headphones
will be free from defects in materials and workmanship for the
period specified below from the date of purchase by the initial
customer.
Product Warranty Period
Neuromonics device:
12 months
Headphones:
12 months
If the product fails under conditions of normal use,
Neuromonics will repair or replace, at its option, the defective
product or any of its components. This is Neuromonics’ sole
obligation under this Limited Warranty. This Limited Warranty
does not cover: a) any damage caused as a result of improper
use, abuse, modification or alteration of the product; or b)
repairs carried out by any service organization that has not
been expressly authorized by Neuromonics to perform such
repairs. Any product repaired or replaced under warranty will
be returned, freight prepaid, to the customer. The cost of
transporting the product to an authorized service organization
will be borne by the customer.
Neuromonics provides a Limited One Year (365 days)
Warranty against Manufacturing Defects for the Oasis.
If the Oasis contained a Manufacturing Defect when it was
purchased from an Authorized Provider, Neuromonics, at its
sole discretion, will (i) repair, (ii) replace, or (iii) provide a
34
Warranty Credit for the Oasis. The amount of the Warranty
Credit shall be equal to the purchase price of the Oasis paid to
the Authorized Provider. Neuromonics reserves the right to
inspect any Product subject to a warranty claim to determine,
at its sole discretion, whether the claimed defect is a
Manufacturing Defect or otherwise. All Warranty Credits and
Aggressive Listener Credits may be used only toward the
purchase of the Neuromonics Oasis.
THIS LIMITED WARRANTY CONTAINS YOUR
EXCLUSIVE REMEDIES. NEUROMONICS DOES
NOT GIVE ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. NEUROMONICS SHALL
NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL
OR CONSEQUENTIAL DAMAGES ARISING FROM
BREACH OF WARRANTY OR USE OF ITS
PRODUCTS, INCLUDING, WITHOUT
LIMITATION, MEDICAL EXPENSES, EVEN IF
NEUROMONICS HAS BEEN ADVISED OF THE
POSSIBLITY OF SUCH DAMAGES.
For further information on your warranty rights contact the
supplier of your device or
[email protected]
35
Musical recordings under license from Naxos of America,
www.naxos.com. ©2001 HNH International Ltd. All rights reserved.
Unlawful duplication, broadcast or public performance of the
recordings is prohibited by applicable law.
Musical works and recordings under license from New Earth
Records. ©2003 Shiva Shakti Music Publishing. All rights reserved.
Unlawful duplication, broadcast or public performance of the
recordings is prohibited by applicable law.
Musical works and recordings under license from Studio Horizon. ©
(P) 1990
Studio Horizon Productions Pty Ltd. All rights reserved. Unlawful
duplication, Broadcast or public performance of the recordings is
prohibited by applicable law.
36
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