Wicab BrainPort V100 Device User Manual
BrainPort
®
V100 Device
User Manual
Wicab, Inc.
8313 Greenwa y Blvd.
Middleton, Wisconsin 53562 USA
BrainPort V100 User Manual 2
Table of Contents
CHAPTER 1 ..................................................................... 5
General Information ........................................................ 5
Purpose of Device (Indications for Use) ............................. 5
Description of BrainPort® V100 ......................................... 6
When NOT TO USE the Device (Contraindications) .............. 7
Risks of Use ................................................................... 7
General Warnings ........................................................... 7
Precautions .................................................................. 12
Clinical Experience ........................................................ 13
Product and Package Labeling ........................................ 14
CHAPTER 2 Using the BrainPort® V100 ....................... 17
User Interface Description .............................................. 19
Contrast ................................................................... 19
Status ...................................................................... 19
Image Mode .............................................................. 20
Lock ......................................................................... 20
Test ......................................................................... 20
Volume .................................................................... 20
Power ...................................................................... 20
Intensity and Invert ................................................... 20
Zoom ....................................................................... 21
Camera Tilt ............................................................... 21
Battery Compartment ................................................ 21
Quick Start: Turning on the BrainPort V100 ...................... 24
Starting vRemote .......................................................... 25
Device Announcements.................................................. 26
Batteries ...................................................................... 28
Battery Charger ............................................................ 29
Battery Precautions ....................................................... 30
Care and Maintenance ................................................... 31
CHAPTER 3 Troubleshooting ........................................ 32
Problems with Battery Power .......................................... 33
Controller Troubleshooting ............................................. 35
Headset Troubleshooting ............................................... 37
vRemote Troubleshooting .............................................. 37
CHAPTER 4 Product Specifications and Technical
References ................................................................... 38
General Specifications ................................................... 38
BrainPort V100 User Manual 3
User Profile .................................................................. 40
Electromagnetic Compatibility ........................................ 41
Warranty ..................................................................... 48
Appendix A Cleansers ................................................... 49
Appen dix B Clinical Safety I nformation ........................ 50
BrainPort V100 User Manual 4
Using this Manual
This manual is in tended f or us e af ter you hav e be en
trained o n the o peration o f the B rainPort
®
V100. T his
manual serves as a reference to supplement your training
and to address any questions you may have when you
use the device at home.
The m anual c ontains ge neral i nformation o n s afety,
operation, and troubleshooting. Please read it thoroughly
and become familiar with its contents.
This manual is written in an accessible format.
• Chapter 1 describes the BrainPort V100 and the risks
and benefits of using it.
• Chapter 2 explains how to use the BrainPort V100.
• Chapter 3 includes troubleshooting procedures to use
in the event of problems with the BrainPort V100.
• Chapter 4 lists product specifications and technical
references.
Attention, consult accompanying documents
This label is a reminder for you to consult
this manual or other material you received
with the device for important safety
information.
Rx only
Caution: Federal law restricts this device to sale by or on the
order of a physician.
BrainPort V100 User Manual 5
CHAPTER 1
General Information
The BrainPort V100 is a non-surgical electronic assistive
prescription device for profoundly blind individuals to aid
in orientation, mobility and object recognition. The
BrainPort V100 is indicated as an adjunct to other
assistive devices, such as the white cane and guide dog.
It translates digital information from a video camera to
gentle electrical stimulation patterns on the surface of the
tongue. Users describe the experience as streaming
images drawn on their tongue with small bubbles. With
training, users are able to interpret the shape, size,
location and motion of objects in their environment.
Warning
The BrainPort V100 does not replace the cane or guide
dog. T he BrainPort V 100 is i ntended to aug ment, rathe r
than re place, o ther assistive t echnologies such a s t he
white cane or guide dog.
Training is required before using the
BrainPort V100.
Purpose of Device (Indications for Use)
The BrainPort V100 is intended for use as an electronic
assistive prescription device for profoundly blind
individuals to aid in orientation, mobility and object
recognition. The BrainPort V100 is indicated as an adjunct
to other assistive devices, such as the white cane and
guide dog.
BrainPort V100 User Manual 6
Description of B rainPort® V100
Headset
A digital video camera is mounted on a pair of sunglasses
at the nose bridge. The camera is capable of working
indoors and o utdoors i n t ypical lighting c onditions. T he
camera’s f ield o f v iew is us er-controlled and v aries f rom
narrow to wide angle views. There are two cables
permanently attached to the l eft e ar pi ece: T he I OD
assembly and the headset cable.
Intra Oral Device (IOD)
The IOD (tongue electrode array) contains electrodes that
act as “pixels” for the tongue. The flat side with the
electrodes should be in contact with the front top surface
of the tongue. Close your lips around the thin stem,
maximizing to ngue contact wi th the e lectrodes. T he
stimulus p attern o n the electrode array corresponds t o
the s cene c aptured by the c amera. T here i s o ne c able
exiting the th in s tem o f the IOD that is pe rmanently
attached to the ear piece of the headset.
Controller
The Controller contains the battery as well as the user
control features for the BrainPort V100. The Controller is
generally handheld. A belt clip is provided for hands free
operation.
Battery Charger
A battery charger with factory instructions is included.
Training and Training PC
Training is required before you use the BrainPort V100.
The trainer may use an accessory personal computer
during training. When the personal computer is in use:
• Do not touch the personal computer or your trainer, and
• Do not come into contact with any device plugged into a
wall circuit.
Your BrainPort V100 does not include or require a
personal computer.
BrainPort V100 User Manual 7
When NOT TO USE the Device
(Contraindications)
You should not use the BrainPort V100 if you have any of
the following conditions:
• Numbness or lack of feeling of your tongue
• History of injuries that impair sensation or use of your
tongue
• Any n eurological c ondition t hat c auses im paired
sensitivity to your tongue or loss of consciousness
Risks of Use
Potential risks arising from the use of the BrainPort V100
include:
• Electrical an d e lectromagnetic s afety hazards
associated with battery-operated devices
• Allergic reaction to the materials in the device
• Irritation o f y our t ongue f rom the e lectrodes or
excessive stimulation
You can manage these risks by setting the stimulus level
according to your preferred comfort level, adhering to the
instructions in this manual, and applying the training you
received for the proper and safe use of the device.
General Warnings
• Long-term use . Limited data are available on the long-
term effects of electrical stimulation of the tongue.
Long-term ef fects (b eyond on e y ear) h ave n ot b een
evaluated in clinical trials.
• Device Usage. Limited data is available on use of the
device exceeding an average of between 250 and 400
BrainPort V100 User Manual 8
minutes per month, and a maximum of 1550 minutes
per month. Wicab recommends that you tailor your
use of the device to be within these time limits since
long-term effects (beyond one year) exceeding this
usage have not been evaluated in clinical trials.
• Trainers. Potential trainers o f us ers o f th e B rainPort
V100 s hould h ave r elevant ex perience, s uch a s
experience working with the blind or visually impaired.
Trainers may have professional credentials, such as
certification as a Certified Low Vision S pecialists
(CLVS), C ertified O rientation and Mobility S pecialist
(COMS) or Teachers of the Visually Impaired (TVI).
All potential trainers will be trained by Wicab according
to W icab pro cedures and o nly tho se who hav e
successfully completed the training will be considered
qualified to train users of the BrainPort V100.
• Supervision. T he BrainPort V 100 should o nly be us ed
after you have completed training. Do not give the
device to untrained individuals for use.
• Use only Wicab supplied components and procedures.
Using controls, adjustments, components, or
procedures o ther than tho se s pecified in this m anual
may damage the BrainPort V100, increase risk, or
decrease benefit.
• Oral Health. L imited d ata is a vailable o n s timulation
sensitivity f or individuals w ith oral conditions s uch as
oral u lcerations, he rpes s implex, o ral t hrush, and
geographic to ngue. I f us e o f the de vice c auses
discomfort, discontinue use.
• Oral Health. I ndividuals w ith h igh, nar row p alatal
vaults should discontinue use of the device if use
causes discomfort
• Oral Health. Individuals w ith m axillary o r m andibular
tori that interfere with the IOD placement such that
full contact with the tongue is prevented should seek
BrainPort V100 User Manual 9
additional training to gain the most benefit of the
device.
• Dental Appliances (orthodontic appliances, removable
partial or full dentures, lingual amalgam alloy
restoration, metal crowns, etc.) Electrical stimulation
of t he t ongue w hen m etal a ppliances/surfaces are
present m ay c hange results and/ or c ause unintended
stimulation. If the stimulation causes discomfort,
remove the IOD from your mouth and discontinue use
of the device. If you notice a change in your dental
device or appliance (warmth or looseness),
discontinue the use of the device and contact your
dentist.
• Dental Implants. The B rainPort de vice ha s no t b een
thoroughly evaluated in the presence of dental
implants. T he s afety o f de ntal implants in B rainPort
users i s u nknown. The use o f this d evice p otentially
may cause heating of dental implants; chronic use of
this device potentially may result in loosening and
failure of dental implants.
• Condition of device. Before EACH use, tactilely inspect
the device for damage, for example, anything rough or
loose on the IOD, disconnected cables, worn cables,
cracked or broken glasses, cracked or broken handset,
etc. If you find these or similar issues, contact
Customer Support and DO NOT use the device. Using
a damaged device could expose sharp edges and/or
the dam age c ould pr event no rmal o peration, the reby
increasing the risk of use.
• Proper environment for use. T he BrainPort V 100 is
intended for use as a supplemental assistive device.
o Do not use it in environments that could put you in
danger.
o Do not operate the device in hot or cold conditions
(below 0°C/32°F or above 40°C/104°F). Maintain
conditions between 5% and 95% relative humidity.
BrainPort V100 User Manual 10
The device is intended for operation under normal
atmospheric pressures (700 hPa to 1060 hPa)
o If the controller becomes uncomfortably warm, or
when the ambient temperature exceeds 35°C/95°F,
use the belt clip to carry the device.
o The controller, camera, and other headset
components are not waterproof. Do not use the
device in environments that will allow liquids (such
as rain and snow) to enter these components.
o Electrical shock. To avoid electrical shock, do
not immerse the BrainPort V100 or the
battery charger in liquids.
o Do not use where flammable gases are present.
o Do not come into contact with any device w hich is
plugged into a wall circuit or any person using such
a device.
o Follow the gui dance o utlined i n CHAPTER 4 –
Product Specifications and Technical References
regarding the intended electromagnetic use
environment.
o Contact W icab if y ou hav e que stions o r co ncerns
about a particular use environment.
• Discomfort. Using the BrainPort V100 should not cause
discomfort. I f you ex perience a ny p ain, n umbness or
discomfort including burning or stinging, please stop
using the device. If the symptoms are temporary, you
may re sume us ing the de vice b y re ducing the
stimulation le vel t o a c omfortable le vel. I f t he
condition re curs, s top us ing the de vice and s eek
professional help.
• Risk of Strangulation. Take care in arranging cables to
avoid the r isk o f s trangulation. Small c hildren m ay
become entangled in the cables. Do not allow children
to use the device. Store the device out of reach of
small children.
BrainPort V100 User Manual 11
• Choking. The B rainPort V 100 c ontains s mall par ts.
Check the device for loose or missing parts before
each use. Do not use the device if parts are missing.
Do no t al low c hildren to us e th e de vice. S tore th e
device out of reach of small children.
• Discomfort. Use of the BrainPort V100 may be
contraindicated for young individuals or people with
narrow dental arcades of the upper palate – it may be
difficult to comfortably place the IOD on the tongue for
these individuals.
• Care and Maintenance. Use only the procedures in this
manual to care for your device.
• Intended Purpose. Do not use the BrainPort V100 for
any purpose other than that stated in the Indications
for Use.
• Personal Computer. When us ing a pe rsonal c omputer
with vRemote:
o Do not allow the user to touch the personal
computer;
o Do no t to uch the pe rsonal c omputer and the us er
at the same time;
o Do not allow the user to come into direct or indirect
contact with any device plugged into a wall circuit;
o Do not use a power strip or extension cord to
power the personal computer;
o The personal computer used to run vRemote is an
accessory that i s us ed o nly by trainers or us ers’
sighted c ompanions, and is no t a m edical de vice
when o perated standalone. I t becomes part o f a
medical device system when used for training and
the precautions listed inside the BrainPort V100
Device User Manual must be followed to insure
client safety.
BrainPort V100 User Manual 12
Precautions
• Signal Stimulation. A djust the s timulation to a
comfortable level that allows you to clearly feel and
respond to the signal. Increasing beyond this point
does n ot i mprove ef fectiveness. If the s timulation
causes discomfort, reduce the stimulation setting to a
comfortable level. If discomfort continues, remove the
IOD f rom y our m outh and discontinue u se o f t he
device.
• Sensitivity to stimulation. Although the BrainPort V100
is de signed to m inimize the r isk o f injury due to
stimulation s trength, i f y ou re act ne gatively to the
stimulation from the BrainPort V100, remove the IOD
from your mouth and discontinue use of the device.
• Oral health. If you currently have or develop open
lesions, sores or abrasions in your mouth, discontinue
use of the BrainPort V100 until the situation has
resolved.
• Mouth injuries/Dental Trauma. The IOD is intended to
be held in the mouth during use. Take care so that the
cables do no t be come entangled, p ulling t he I OD out
of your mouth potentially injuring your mouth, teeth
or lips.
• Choking. The IOD is intended to be held in the mouth
during us e. T o m inimize the r isk o f c hoking o n the
IOD, make certain it is securely connected to the
flexible c able and th at the I OD i s positioned p roperly
in the mouth. Do not use the device if the IOD is
damaged.
• Neck Trauma. Take c are s o that y ou do not be come
entangled in the c ables that run f rom the he adset to
the c ontroller. A s udden y ank c ould c ause ne ck
trauma.
• Batteries. Do n ot u se t he d evice with the batte ry
compartment door open. Inspect the battery prior to
use. Do not use the battery if it appears damaged,
BrainPort V100 User Manual 13
corroded, is leaking, or is swollen.
• Connections. Do not attempt to connect the headset
to equipment other than the BrainPort V100 controller.
Doing so may d amage the BrainPort V 100, i ncrease
risk, or decrease benefit.
• Connections. Do not attempt to connect anything
other than the headset that came with your unit to the
BrainPort V 100 c ontroller. D oing s o may damage the
BrainPort V100, increase risk, or decrease benefit.
Clinical Experience
The BrainPort V100 device was evaluated in a single arm,
open label clinical study of 75 enrolled blind/profoundly
blind subjects from 7 s ites i n the U .S. and C anada.
Subjects unde rwent 2 -3 day s ( 10 ho urs) o f tra ining
followed by in-home use over the span of 12 months for
the study.
The p rimary s afety endpoint was no o ccurrence o f a
clinically s ignificant device-related a dverse e vent. A
clinically s ignificant device-related adv erse e vent wa s
defined as any e vent that resulted i n to ngue b urns
attributed to use of the BrainPort V100 device, an allergic
reaction requiring medical care, or negatively altered
changes in taste or numbness that was sustained and/or
resulted in withdrawal from the study. The primary
efficacy e ndpoint w as su ccess i n a t est of ob ject
recognition of at least 50%. The secondary endpoints
measured success rates of at least 50% in tests of word
identification a nd at l east 3 5% i n s ign identification i n a
mobility task. Effectiveness e ndpoints we re m easured at
12 month follow up, and safety events were captured
throughout the study.
Study results demonstrated that the safety objective was
achieved, with no clinically significant d evice-related
adverse e vents thro ughout the s tudy. There w ere n o
serious device-related adverse events. Two (2.67%) of
BrainPort V100 User Manual 14
the s tudy s ubjects re ported m ild/moderate e vents
possibly/probably related to the device that led to
decrease i n d evice u se or d iscontinuation of d evice u se.
One subject reported worsening sinus drainage that was
considered a po ssible m etal a llergy and p ossibly re lated
to the device. Device use was discontinued for this
subject. One subject reported tongue soreness that wa s
considered pro bably related to the de vice. D evice us e
decreased for this subject. Both subjects recovered. For
a complete list of device-related adverse e vents that
occurred in the clinical study of the device, see Appendix
B.
In te rms o f e ffectiveness, the pri mary e fficacy o bjective
was achieved with more than 50% of subjects achieving
success o n the object re cognition tas k. Results o f the
secondary efficacy endpoints similarly confirmed device
performance, where approximately 44% of subjects were
able to successfully complete the word identification and
mobility tasks (where subjects with missing data were
counted as failures for a conservative analysis). Based on
all av ailable data at the e nd o f the s tudy, i.e., the “pe r
protocol” subjects who completed 12 month follow up,
57.9% of the study subjects successfully completed the
word identification and mobility tasks.
Overall, evaluation of the safety and efficacy of the
BrainPort V100 device demonstrated a low-risk safety
profile with no serious device-related adverse events, and
strong effectiveness results confirming d evice
performance in the intended user population.
Product and Package Labeling
The labels on the back of the BrainPort V100 controller
and on its packaging provide important information. You
will ne ed the m odel nam e, model num ber, r eference
number, and s erial num ber if y ou call W icab for
assistance. See t he inside bac k c over o f t his m anual for
contact information.
BrainPort V100 User Manual 15
Product Label
Explanation of Symbols
Important safety information is contained in the
documents that accompany the device.
Year of manufacture
The BrainPort V100 includes RF transmitters
Keep the BrainPort V100 dry.
Dispose of in accordance with WEEE
Serial Number
Reference Number
SN
REF
BrainPort V100 User Manual 16
Package Label
Explanation of Symbols
Humidity range for transportation
and storage
Fragile
Temperature range for
transportation and storage
Keep dry
Important safety information is
contained in the documents that
accompany the device.
Year of manufacture
Dispose of in accordance with WEEE
BrainPort V100 User Manual 17
CHAPTER 2
Using the BrainPort® V100
This chapter explains how to set up and use the BrainPort
V100.
(Refer to Figure 1: BrainPort V100 and/or the verbal descriptions below)
Using procedures other than those specified in
this manual may damage the BrainPort V100,
increase risk of injury, and decrease benefits of
use.
Before EACH use, tactilely inspect the device
for damage, for example, anything rough or
loose on the IOD, disconnected cables, etc. If
you find any of these problems, contact
Customer Support and DO NOT use the device.
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