Wistron NeWeb DRCM Part 15 Spread Spectrum Module (802.11 B/G) User Manual Page 1

Wistron NeWeb Corporation Part 15 Spread Spectrum Module (802.11 B/G) Page 1

Contents

User Manual

BrainPort® V100 Device User Manual Wicab, Inc. 8313 Greenway 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 Appendix B Clinical Safety Information ........................ 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 BrainPort® 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 i s 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 c onditions 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 thi s 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 y ou 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 e ntangled, 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 po sitioned 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% in 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.
BrainPort V100 User Manual 18 Figure 1: BrainPort V100 BrainPort® V100 Device Components 1 Headset 2 Camera – Image Sensor 3 Camera Tilt Knob 4 Contrast Button 5 Power Indicator LED 6 Stimulation Indicator LED 7 IOD Receptacle 8 Zoom Dial / Zoom Home 9 Intensity Dial / Invert 10 Status Button 11 Image Gain LOCK 12 IOD (Intra-Oral Device) with Tongue Array 13 Test Button 14 Image Mode Button 15 Headset Connector 16 Option Button 17 Headset Cable 18 Power ON/OFF Button
BrainPort V100 User Manual 19 User Interface Description The BrainPort V100 may be held in either hand with the bottom end of the controller (point of headset connection) facing downwards and the front panel of the controller with six raised buttons facing toward the user. Four of the raised buttons on the front panel of the device are oriented in a diamond pattern, located at 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock. There are two additional buttons on the front panel near the bottom of the controller. On each side of the device there are wheels that both rotate and act as a button when pressed in. Wicab recommends holding the device so that your thumb rotates one wheel and your forefinger rotates the other wheel. Finally, on the bottom of the controller, next to the connector is a button controlling power on and off. Pressing the buttons or wheels will emit a beep and a voice will announce the information assigned to each button. Some actions also trigger a vibration felt in the hand. Button descriptions and uses are provided below. Contrast (12 o'clock button- 4): This button toggles between standard contrast (default) and high contrast mode. PRESS once to activate high contrast and PRESS again to return to normal contrast. Status (3 o'clock button- 10): PRESS and release of this button provides a quick status of the battery percentage and zoom level in degrees field of view. PRESS-HOLD the button for one second to hear additional status information such as battery level, zoom level, intensity level, lock status, and invert status, tilt, low light status.
BrainPort V100 User Manual 20 Image Mode (6 o'clock button- 14): This button is a three state toggle. PRESSing it once makes a bright image more detailed on the tongue, PRESSing it twice makes a darker image more detailed on the tongue, and PRESSing it three times returns to default image mode. Lock (9 o'clock button- 11): This button toggles between allowing the camera to automatically adjust to the lighting conditions (default) and locking that feature. The device will announce whether lock is on or off. Test (Bottom left button- 13): PRESSing this button displays a test pattern on the tongue array to enable confirmation that the tongue display is active. To stop the test pattern press the Test button a second time. Volume (Bottom right button- 16): This button toggles between three volume levels: high volume, low volume (default), and mute/vibrate only. Note: You cannot mute the status button. Power (18): Located o n the narrow end o f the controller, next to the headset connector housing is a small button controlling power on and off. To turn the device on or off, PRESS the button for two seconds. Intensity and Invert (Left Wheel- 9): On the left side of the controller is a rotating wheel that also acts as a button when PRESSed. This wheel controls stimulation intensity, while the button controls the invert function. Turning the wheel up (towards the top of the controller) increases the intensity of the stimulation on your tongue. Turning the whe el down ( towards the bo ttom o f the controller) d ecreases the intensity o n y our t ongue. T he device will vibrate at the limits of stimulation (highest = 100, l owest = 0 ). At po wer up, s timulation intensity always re sets to ze ro and m ust be i ncreased to y our comfortable working level.
BrainPort V100 User Manual 21 A PRESS of t he stimulation wheel activates the Invert feature that inverts the stimulation intensity values – strongest becomes weakest and vice-versa. The Invert Feature is used to toggle between whether bright objects or dark objects in the field of view stimulate the tongue array. Zoom and Home (Right Wheel- 8): On the right side of the controller is a rotating wheel that also acts as a button when PRESSed. The wheel and button control the zoom level of the camera. Turning the wheel up (towards the top of the controller) zooms the camera in (reducing the camera’s effective field of view). Turning the wheel down (towards the bottom of the controller) zooms the camera out (increasing the camera’s field of view). The device will vibrate at the limits of zoom (widest = 69 degrees, narrowest = 3 degrees). PRESSing the wheel straight in activates the home zoom position. The default home position is a medium field of view (24 degrees). To set the home zoom position, use the right zoom wheel to achieve the desired field of view and then PRESS and hold the right wheel for two seconds. Camera Tilt (3): On the left side of the headset temple is a small round wheel with a tactile line in the middle. Prior to start up, make sure the tactile line is positioned horizontally. Upon start up, rotating the knob through its positions (all the way down and all the way up) calibrates the digital camera tilt. You will hear a tone once tilt has been initialized. The tilt knob is non-functional until it has been calibrated. The raised tactile line indicates the direction of tilt. Battery Compartment: On the back of the unit is a sunken well. Insert a finger into the well to grasp the lip
BrainPort V100 User Manual 22 of the battery cover door and pull straight back, away from the controller, to open the battery compartment. A fully charged battery should always be used at the start of each session. Companion Software (vRemote) Letters in parentheses refer to Figure 2. vRemote below. The vRemote software program runs on a personal computer and can be used by a sighted companion to view the images collected by the BrainPort V100 camera and presented to the IOD. The Camera View (A) represents a generally higher resolution view of the scene detected by the camera. The yellow box in the Camera View (A) represents the region of interest (zoom/field of view) that the user has chosen. The IOD View (B) is a visual representation of the information being sent to the IOD (derived from the region of interest). vRemote is not to be used by the companion to provide any instructions to the user, but is simply for watching. The companion software can be used as an assistive tool for practice following standard device training with a Wicab certified trainer. Note: The personal computer used to run the vRemote software must have an operating system of Windows XP or higher (.NET 4.0 or higher), and must be able to establish an ‘ad-hoc’ Wi-Fi connection (minimum 802.11 a/b) with the BrainPort V100 device.
BrainPort V100 User Manual 23 A B C E D Figure 2. vRemote A. Camera View B. IOD View C. Device Name (Serial No.) D. Connect/Disconnect Button E. Refresh Button
BrainPort V100 User Manual 24 Quick Start: Turning on the BrainPort V100 Numbers in parentheses refer to Figure 1: BrainPort V100 1. Fully charge the batteries included with your device prior to using your BrainPort V100 for the first time. 2. Wicab recommends that you thoroughly clean the IOD before using it for the first time. Use the alcohol towelette (included with y our de vice) to clean the IOD. Allow to air dry. Thoroughly rinse the IOD with tap water. Your IOD is ready for use after the rinse. See “Care and Maintenance” for detailed instructions on how to clean the IOD. 3. The h eadset c able c onnector (15) is attac hed to a receptacle at the base of the Controller near the Power On/Off button (18).This will be considered the bottom of the Controller. 4. Insert a f ully c harged battery into the b ack o f the Controller. 5. Verify that the Tilt Knob (3) is at its home position by rotating it up (clockwise) until it reaches its stop position (do not force past the stop point). 6. There are two way s to u se the B rainPort V 100: i n standalone mode, or in Wi-Fi mode to connect to the companion vRemote software. Standalone Mode To turn on the BrainPort V100 in standalone mode, PRESS the Power On/Off button (18) at the bottom of the C ontroller. After po wer-up, the re i s a series of one s econd t icks followed b y ( ~35 se c) the phras e “active mode” which indicates the BrainPort V100 has completed its self-test and is ready for use. WiFi Mode To turn on the BrainPort V100 in Wi-Fi mode, hold both wheels (8 and 9) in towards the middle of the controller t hen PRESS the P ower O n/Off b utton (18)
BrainPort V100 User Manual 25 at the bo ttom o f th e C ontroller. T he C ontroller w ill double beep, perform the same power up self-testing as above, and then announce “Wi-Fi enabled” “active mode”. You may release the wheels after the initial double beep. Starting in W iFi m ode i s ne cessary i f y ou wi sh to connect to vRemote 7. Place the headset onto your head and make any adjustments for comfort. 8. Initialize camera t ilt b y rotating the t ilt knob (3) down (c ounter-clockwise) and bac k to its s tart position, until an initialization double beep is heard. This ensures that the device tilt range is maximized. 9. Hold the C ontroller in y our r ight han d with the buttons o f the f ront pane l f acing to ward y ou for purposes of these instructions. 10. Place the I OD i n y our m outh. U se t he stimulation intensity dial on the left side (9) of the Controller to control stimulation intensity. 11. The c amera f ield o f v iew ( zoom) wi ll d efault to a medium field of view (24 degrees). This can be changed by using the Zoom dial (8). 12. To sh ut down the s ystem, PRESS-HOLD the P ower On/Off button (18) until all beeps are finished (approximately 4 seconds). Starting vRemote If your sighted companion will be using the personal computer with vRemote software, follow the instructions below: 1. Start the V100 in WiFi mode.
BrainPort V100 User Manual 26 2. Power-on the personal computer and wait for the operating system to boot. 3. Open the vRemote program and click the Refresh button. 4. Each unit is configured with an Ad Hoc network corresponding to its serial number. From the drop-down menu in vRemote, choose the wireless network that matches the numeric portion of the device serial number of the user’s device. For instance if the device serial number is SN000079, select wireless network BPV-000079. Press the Connect button to connect to the Wi-Fi network. The device will announce “Wi-Fi connect” and the camera image will appear inside vRemote. 5. A Camera View (A) and IOD View image (B) should appear in vRemote on the personal computer. Note: a. Reminder: Review Personal Computer under General Warnings. 6. To turn off the system, turn off both the BrainPort V100 device and the personal computer; order is not important. a. Exit the vRemote application and power down the personal computer. Device Announcements During use, the device will produce a variety of announcements following button presses. These announcements let the user know which button was pressed and what c hanges hav e be en m ade to the camera or IOD. Sometimes the device may detect change in environmental conditions. Low Light
BrainPort V100 User Manual 27 In low light conditions, the device will announce “low light” one time per session. A long PRESS of the Status button will reveal whether the conditions remain low light. This announcement is used to remind users to optimize their lighting conditions (i.e. turn on a light) in order for the camera to capture a useful image. LOW BATTERY When the battery l evel decreases to a low level, the device will repeatedly announce “low battery”. T his announcement ac ts as a re minder that a re placement battery should be inserted in order to continue using the device. STANDBY MODE The de vice wi ll ann ounce “standby m ode” when t he headset is not properly connected to the controller. When the d evice i s in standby m ode, no butto n wi ll f unction until the device returns to active mode. ACTIVE MODE The device will announce “active mode” upon completion of start-up testing or when the headset connection has been restored. The device is ready for use while in active mode. WI-FI MODE The device will announce “Wi-Fi enabled” upon activation of the Wi-Fi module and completion of start-up testing. The device is ready to connect to the vRemote software while in Wi-Fi mode. When the device connects with the vRemote software, the device will announce “Wi-Fi connect”. When the device is disconnected from vRemote, it will announce “Wi-Fi disconnect”.
BrainPort V100 User Manual 28 Batteries The system includes a rechargeable Lithium-Polymer battery, c harger and c harging instructions. W hen f ully charged, a batte ry provides approximately three hours of standard usage. A given battery has an expected life of more than 5 00 c harge c ycles. A f ully c harged batte ry should always be used at the beginning of each session. To replace the battery, open the door on the back o n the Controller b y i nserting a f inger into the re cessed a rea and s winging the door toward the end of the box where the cable connects. To remove the battery, grip the top of the battery and pull outward. To replace the battery, align the exposed metal connectors to the metal connectors in the Controller and snap the battery into place and close the door. To test the battery power while using the BrainPort V100, use a PRESS of the Status button. The speaker will report the appro ximate p ercentage o f c harge re maining f or the installed b attery. In a low b attery c ondition, the d evice may shutdown automatically to avoid improper operation. Avoid direct contact with the gold contacts located in the battery compartment and on the battery. • If you will not be using the BrainPort V100 for a period of more than 5 days, remove the battery. • Storage and Transportation Conditions: o Temperature: -20°C to +45°C o Humidity: 5% to 85%
BrainPort V100 User Manual 29 The nearby figure shows the location of the Battery Manufacturer Part Number. BrainPort V100 Battery Specifications Wicab Part Number DR-000839 Manufacturer Part Number 56446 702 099 Battery Type Rechargeable Li-Polymer Electrical Specification - 3.7V - 2260mAh - 8.4Wh Storage and Transportation Conditions - Temperature: -20°C to +45°C - Humidity: 5% to 85% Charge Cycles > 500 Battery Charger A c opy o f the batte ry c harger m anual is pro vided w ith your BrainPort V 100. Follow the manufacturer’s instructions when charging your battery. Avoid direct contact with the gold contacts located in the pocket of the charger. Do not power the charger using a power strip or extension cord. Battery Manufacturer Part Number
BrainPort V100 User Manual 30 Battery Precautions  Avoid short circuits  Do not heat the batteries above 60°C  Do not dispose of batteries in fire  Do not solder directly to the battery  Do not charge with more that 1C and above 4.2V  Do not charge below 0°C or above 45°C  Do not discharge with more than 1C and below 2.7V  Do not discharge below -20°C or above 60°C  Do not disassemble the batteries  Do not insert the batteries in reverse polarity  WARNING: FIRE, EXPLOSION, AND SEVERE BURNS HAZARD Personal injury can occur if the battery is handled carelessly or improperly. For your safety, follow these instructions for proper battery handling: • The battery can ignite or explode if not handled properly. If you notice any deformities, cracks, or other abnormalities in the battery, immediately discontinue use of the battery and contact the manufacturer. • Use only authentic, manufacturer-recommend battery chargers and charge the battery only by the method described in this user manual. • Do not place the battery near heating devices or expose to excessively warm environments, such as the inside of an enclosed car in the summertime. • Do not place the battery in a microwave oven. • Avoid storing or using the battery in hot, humid places, such as spas or shower enclosures
BrainPort V100 User Manual 31 Care and Maintenance • If you will not be using the BrainPort V100 for a period of more than 5 days, remove the battery. • Thoroughly rinse the IOD with tap water as needed to remove c ontaminants. Y ou m ay us e i t i mmediately following such a rinse. • Wicab recommends that you clean the IOD once a week. Use the cleaning solutions listed in Appendix A on a c otton bal l o r cotton swab to g ently w ipe the surfaces of the IOD. DO NOT SCRUB! Thoroughly rinse the IOD with tap water to remove any residual cleaning solution and allow it to air-dry. • As n eeded, u se a cloth slightly dam p with wate r to wipe the ex terior of the c ontroller, he adset, and battery charger. DO NOT rinse or immerse the controller, he adset, or the batte ry c harger. A fter cleaning, a llow the controller, he adset, and b attery charger to dry completely before use. • DO NOT store or transport the device in extreme hot or c old c onditions ( except f or batte ries – see a bove section). Storage and Transportation Conditions: o Temperature: -25°C to +70°C o Humidity: 5% to 95% • DO NOT bend, fold, or crush the IOD cable as this may permanently damage the IOD. • Always protect the IOD. T o avoid damaging the IOD, follow these instructions: o Do not drag the IOD electrode surface across an object; o Do not strike the IOD against a hard object; o Do n ot a llow t he I OD t o c ome i n c ontact w ith o ther electrical e quipment s uch a s c ell p hones, c ell p hone chargers, portable music players, etc.
BrainPort V100 User Manual 32 CHAPTER 3 Troubleshooting This chapter describes steps you can take if the BrainPort V100 does n ot s eem to be wo rking pro perly. Y ou m ay need the assistance of a sighted individual to help with troubleshooting. If the troubleshooting procedures do not help, if you need further assistance, or if you think the device may need service, use the information on the inside back cover of this manual to contact Wicab. The BrainPort V 100 has n o u ser-serviceable parts and does no t re quire ro utine adj ustment o r c alibration. Y ou will void your warranty if you attempt to service the BrainPort V100. DO NOT attempt to repair the BrainPort V100 yourself. To insure that y ou receive accurate real time information representative of the scene captured by the camera, the device self-monitors and transitions from active mode to standby m ode ( stimulation d isabled) w henever an irregularity o ccurs. T his is the no rmal and i ntended behavior o f the de vice as i t insures that you d o no t ac t upon potentially compromised or significantly time delayed visual information. You must take action to return to ac tive m ode. The d evice pre vents a re turn to active m ode i f the i rregularity pe rsists. If the de vice emits 3 warning beeps and stops functioning, simply turn the power off, then restart the device as usual.
BrainPort V100 User Manual 33 Problems with Battery Power The B rainPort V 100 batte ry s tatus re ports the estimated percentage of power remaining, assuming a fully charged battery was installed at the beginning of the session. In cases wh ere a p artially c harged batte ry i s us ed, the battery report may be misleading and put the device into low battery states more quickly than expected. When the battery in the BrainPort V100 nears the end of its useful life it may take longer to recharge and the duration of use following a recharge may be shorter. If you notice these changes, or suspect that you have other battery related problems, execute the steps below before contacting Wicab. The BrainPort V100 uses a rechargeable battery that contains electronic components that address safety requirements and that increase its useful life. These electronic components are not present in over-the-counter batteries. Using any other battery may damage the device and increase risk of use. The battery charger supplied with the BrainPort V100 is specifically designed for use with the battery of the BrainPort V100. Using any other battery charger may damage the device and increase risk of use. Do not use the device with the battery compartment door open. Perform t he f ollowing s teps t o i dentify t he s ource of a battery power problem. 1. Follow the instructions in the batte ry c harger m anual to insure the charger is working properly. If the behavior o f y our batte ry c harger d oes no t m atch the operation described in the manual, the problem is most l ikely to be wi th the batte ry c harger. U se the information on the inside back cover of this manual to
BrainPort V100 User Manual 34 contact Wicab to report the charger problem. 2. If the charger functions correctly, fully charge a battery. O nce c harged, p lace the batte ry into the BrainPort V100 controller and attempt to power up the controller. I f the controller d oes no t illuminate the green power-on light or begin the startup ticks, repeat the pri or te st w ith y our s econd batte ry. I f the controller still does not illuminate the green power-on light o r e mit the s tartup t icks, the pro blem i s most likely to be with the controller. Use the information on the inside back cover of this manual to contact Wicab to report the controller problem. If, ho wever, the gre en po wer-on l ight illuminates o r startup ticks begin with one, but not the other, of your batteries, the pro blem i s most likely w ith the b attery that fails to power up the controller. Use the information on the inside back cover of this manual to contact Wicab to report the battery problem. 3. With the f ully c harged batte ry inserted, turn y our system o n and no te the ti me. I f af ter t wo ho urs o f continuous operation, if the device is functioning, your battery i s f unctioning as e xpected. Repeat the tw o hour te st on y our second batte ry. Should e ither battery fail to operate the device for two hours or more, the batte ry is l ikely ne aring the e nd o f i ts natural life. U se the i nformation o n the i nside bac k cover of this manual to contact Wicab. 4. If you reach this point, your batteries are mostly likely functioning properly. If you continue to have problems with your device, proceed to the controller troubleshooting section below.
BrainPort V100 User Manual 35 Controller Troubleshooting Perform the following steps if you suspect a malfunction with the controller. If you identify a problem with the controller and c ontact W icab, t he s upport s taff m ay as k for the serial number of the controller. This is found on the system label on the rear of the unit (see Product Label in Chapter 1). 1. Place a f ully c harged b attery i nto the c ontroller and attempt to po wer up the c ontroller. I f th e c ontroller does not illuminate the green power-on light or begin the s tartup t icks, pe rform the bat tery po wer troubleshooting procedure described above before continuing with troubleshooting of the controller. 2. If the c ontroller illuminates the gre en po wer-on l ight and begins the startup ticks, but does not produce the ready for operation announcement of “active mode”, the problem is most likely to be with the controller. Use the information on the inside back cover of this manual to c ontact Wicab to re port th e controller problem. 3. If t he c ontroller s uccessfully c ompletes t he s elf-test, depress each of the buttons and dials in turn. The controller s hould b eep wi th e ach d epression. I f th e controller d oes n ot beep f or ev ery d epression of a button o r d ial, the p roblem is m ost likely t o b e w ith the controller. Use the information on the inside back cover of this manual to contact Wicab to report the controller problem. 4. If the controller successfully recognizes button and dial depressions, rotate the stimulation dial and verify the stimulation light illuminates yellow and that you feel stimulation on your tongue from the IOD. If the yellow stimulation light fails to illuminate or you do not feel any stimulation, the problem is most likely to be with the controller. Use the information on the inside back c over o f thi s m anual to c ontact Wicab to re port the controller problem.
BrainPort V100 User Manual 36 5. If the yellow stimulation light illuminates or you can feel stimulation, remove the IOD from your mouth. Rotate b oth the s timulation and zo om d ials through their f ully up and f ully do wn po sitions. V erify the controller v ibrates whe n the m aximum a nd m inimum stimulation and zoom levels are reached. If the controller does not vibrate when a limit is reached, the yellow s timulation light s tays i lluminated, or y ou f eel stimulation when the stimulation dial is rotated to minimum, the problem is most likely to be with the controller. U se the i nformation o n the i nside bac k cover of this manual to contact Wicab to report the controller problem. 6. If you reach this point, your controller is mostly likely functioning properly. If you continue to have problems with your device, proceed to the headset troubleshooting section.
BrainPort V100 User Manual 37 Headset Troubleshooting 1. Perform the following step if you suspect a malfunction with the headset. If you identify a problem with the headset and contact Wicab, the support staff may ask for the serial number of the headset. This is found on the l abel located o n the i nside o f the gl asses on the left hand s ide. P erform the c ontroller tro ubleshooting section; including a test of your batteries as noted in step o ne. I f bo th y our b atteries and c ontroller are functioning properly, then the problem is most likely with the he adset. U se the i nformation on the in side back c over o f thi s m anual to c ontact Wicab to re port the headset problem. vRemote Troubleshooting 1. Delayed camera image. Due to Wi-Fi limitations an occasional delay in the camera image may occur. To minimize delay the distance between the personal computer and Controller should be less than 6 meters (20 feet). 2. Intermittent connection problems. Replace the battery with a fully charged battery in the Controller. Follow instructions in “Starting vRemote”. 3. Device serial number not listed in “Wireless Connection” dialog on the personal computer. Replace the battery with a fully charged battery in the Controller. Follow instructions in “Starting vRemote”. If you continue to experience difficulties with the device or the vRemote software, contact Wicab for assistance.
BrainPort V100 User Manual 38 CHAPTER 4 Product Specifications and Technical References This chapter provides technical reference material that may be useful to you, your doctor, your trainer, or local, state, and national regulatory agencies. General Specifications Type BF Equipment Physical Length 13.3 cm width 5.6 cm height 3.5 cm (excluding belt clip) weight <175 g (including battery) Cable length to headset 106 cm Power Internally powered by a lithium polymer rechargeable battery (3.7V, 2260mAh, 8.4Wh) Output Waveforms Monophasic Capacitive coupling Pulse Frequency 200 Hz Pulse Width 25 µs Surface Area 0.46 mm² (per electrode) Voltage 0 to 1.414 V rms (per electrode) 0 to 14.14 V rms (device) Current 0 to 0.518 mA rms (per electrode) 0 to 20.7 mA rms (device) Energy/pulse 10.35µJ (see note below) Materials The BrainPort V100 is not made with natural rubber latex Disposal Many localities have recycling requirements for batteries, electronic equipment, and packaging. Recycle or dispose of the device and its packaging in accordance with local ordinances. Environmental Conditions Operating Conditions: - Temperature Range: 0°C to +40°C - Humidity Range: 5% to 95%
BrainPort V100 User Manual 39 - Atmospheric pressure range of 700 hPa to 1060 hPa Storage and Transportation Conditions (except batteries): - Temperature Range: -25°C to +70°C - Humidity Range: 5% to 95% Storage and Transportation Conditions (batteries): - Temperature Range: -20°C to +45°C - Humidity Range: 5% to 85% IP Classification The BrainPort V100 is classified as IP20. The device is protected against solid foreign objects over 12 mm. Regarding 60601-1-11 8.3.1: Other than the IOD assembly, the V100 device is not designed to prevent ingress of water or other liquids per test of IEC 60529:1989 for IPX2. However, in all cases the device maintains BASIC SAFETY and ESSENTIAL PERFORMANCE (which may include cessation of operation) after undergoing the test. The IOD assembly is IPX4 rated (protection against splashing water) Intended Conditions for Use - Non-Sterile - Used in the home environment - Used to augment white cane or guide dog. Does not replace white cane or guide dog. - Typical duration of use: multiple sessions per day, usually less than an hour per session Part Numbers Controller: DR-000994 (V100) Headset: DR-000649 Battery: DR-000839 (56446 702 099) Declaration of Conformity The CE mark on this product indicates it complies with the provisions noted in the 93/42/EEC Medical Device Directive. Note: Stimulation is voltage controlled and limited to 20.0 Volts. Stimulation current depends on variations in user physiology and with the pressure of the tongue against the electrode array. Values given for current and energy per pulse are at maximum voltage into a 2770 Ω load, for a single electrode. Up to four electrodes may be active at any given time; therefore the current may exceed 10mA rms.
BrainPort V100 User Manual 40 User Profile User For use by individuals who are profoundly blind. Education Completed traditional blindness rehabilitation: white cane, and/or guide dog, and rehabilitation in activities of daily living Knowledge Minimum: ability to understand verbal training instructions Reading and comprehension at 10th grade level Experience All users must participate in a minimum of 10 hours of supervised training per Wicab’s training protocol prior to unsupervised use of the device Permissible Impairments Diagnosis of no light perception or light perception Blindness may be acquired or congenital Absence of oral sensory impairments
BrainPort V100 User Manual 41 Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding electromagnetic compatibility. The BrainPort V100 should be used according to the electromagnetic compatibility information provided below. NOTE: The BrainPort V100 (DR-0001062) uses WiFi and an antenna. The following information is included for reference. Your BrainPort V100 contains a Wi-Fi transmitter and receiver with the following characteristics: FCC ID NKRDRCM Description WLAN 802.11B/G CF MODULE Model No. DRCM-81 Frequency Range 802.11b/g: 2400~2483.5 MHz Support channels for 802.11b/g 11 Channels Antenna Type Antenna peak Gain Dipole 2 dBi (11b/g) Other e quipment m ay i nterfere w ith th is device, even i f that other equipment complies with CISPR emission requirements. This equipment has been designed to comply with the limits for a Class B digital device, pursuant to Part 15 of the F CC R ules. These l imits are d esigned to pro vide reasonable protection against harmful interference in a residential installation. T his e quipment g enerates, us es, and c an radi ate ra dio f requency e nergy and , if no t installed and used in accordance with the instruction, may cause harmful interference to radio communications. There is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to rad io o r te levision re ception, which c an be d etermined by turn ing th e e quipment o ff and on, the user is encouraged to try the correct the interference by one of the following measures:
BrainPort V100 User Manual 42 − Reorient or relocate the receiving antenna. − Increase the s eparation be tween th e e quipment and receiver − Consult the d ealer o r an e xperienced rad io/TV technician for help. The BrainPort V100 has been tested and found to conform to IEC 60601-1-2 and is intended for use in the electromagnetic environment specified in the following tables. I f y ou m ust us e the BrainPort V 100 in c lose proximity to other electronic equipment, observe the device to verify normal operations before starting use. Note: The f ollowing t ables u se t he Eu ropean c onvention of representing decimal values with a comma instead of a period as is done in the United States. For example, the value “2,5 GHz” in Table 204 is typically written “2.5 GHz” in the United States.This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
BrainPort V100 User Manual 43 Table 1: Electromagnetic Emissions The user of the BrainPort V100 should ensure that it is used in the intended environment, as specified below. Guidance and manufacturer’s declaration – electromagnetic emissions The BrainPort V100 is intended for use in the electromagnetic environment specified below. T he cu stomer or t he u ser o f t he BrainPort V 100 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The BrainPort V100 must emit electro-magnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The product is considered Group 1 - the emitted energy is below 9kHz. RF emissions CISPR 11 Class B The BrainPort V100 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network, which supplies power for buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Not applicable (internally powered) Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable (internally powered)
BrainPort V100 User Manual 44 Table 2: Electromagnetic Immunity The user of the BrainPort V100 should ensure that it is used in the intended environment, as specified below. Guidance and manufacturer’s declaration – electromagnetic immunity The B rainPort V 100 is intended for u se in t he e lectromagnetic e nvironment specified below. The customer or the user of the BrainPort V100 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 ±8 kV contact ±15 kV air ±8 kV contact ± 15 kV air Floors should be wood, concrete, or ceramic tile. If floor covering is 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 Not applicable (internally powered) (No input/output lines) Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth Not applicable (internally powered) Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 <5% Ut (>95% dip in Ut) for 0,5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec Not applicable (internally powered) Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical commercial building or hospital or home. Note: Ut is the a.c. main voltage prior to application of the test level.
BrainPort V100 User Manual 45 Table 3: Electromagnetic Immunity Users of the BrainPort V100 should ensure that it is used in the intended environment, as specified below. Guidance and manufacturer’s declaration – electromagnetic immunity The BrainPort V100 is intended for use in the electromagnetic environment specified below. The customer or the user of the BrainPort V100 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 the BrainPort V100, including cables, than the recommended separation distance calculated from the equation that applies to the transmitter’s frequency. Recommended separation distance Conducted RF IEC 61000-4-6 6 Vrms; 150 kHz to 80 MHz 6 V d =1,2√P Radiated RF IEC 61000-4-3 10 V/m; 80 MHz to 2,7 GHz 10 V/m d =1,2√P 80 MHz to 800 MHz d =2,3√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 metres (m). Field strengths from fixed RF transmitters, as
BrainPort V100 User Manual 46 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 range applies. Note2: 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 e lectromagnetic e nvironment d ue to fixed RF transmitters, consider doing an electromagnetic site survey. If the measured field strength in the location in which the BrainPort V100 is used exceeds the applicable RF c ompliance level above, observe the BrainPort V 100 to verify normal operation. If you detect abnormal performance, additional measures may be necessary, such as reorienting or relocating the BrainPort V100. b Over the f requency range of 150 kHz to 80 MHz, field s trengths s hould b e less than 10 V/m.
BrainPort V100 User Manual 47 Table 4: Recommended Separation Distances Users of the BrainPort V100 should ensure that it is used in the intended environment, as specified below. Recommended separation distances between portable and mobile RF communications equipment and the BrainPort V100. The BrainPort V100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the BrainPort V100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BrainPort V100 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 M 150 kHz to 80 MHz d = 1,2√P 80 MHz to 800 MHz d = 1,2√P 800 MHz to 2,5 GHz d = 2,3√P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power 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.
BrainPort V100 User Manual 48 Warranty Limited Product Warranty. Wicab, Inc. (the “Company”) warrants to the purchaser (“Purchaser”) (limited to the original Purchaser and to no other person) that the Product and the component parts thereof manufactured and distributed by the Company will meet the specifications stated on the Product specification sheets and shall be free from defects in workmanship and materials f or a period of two years ( Service Life) measured from t he date the Product is shipped to the Purchaser (“Warranty Period”). If any component of the Product does not conform to these specifications, the Company will, at its sole discretion, as its sole and exclusive liability and as to the Buyer's sole and exclusive remedy, repair or replace the Product with a new or factory reconditioned Product at no charge or refund the cost of the Product; provided that notice of nonconformance (setting forth in reasonable detail the nature of the nonconformance) is given the Company within the Warranty Period and within 30 calendar days of the discovery of the defect or nonconformance. This warranty limits the Company's liability to the repair or replacement of Product or refund of the cost of Product. No other warranties of any kind, express o r i mplied, i ncluding w ithout l imitation, a n i mplied w arranty o f merchantability or fitness for a particular purpose or noninfringement, are provided by company. Company shall in no event be liable for personal injury or property damage or any other loss, damage, cost of repair, or direct, indirect, incidental, special, consequential, or punitive damages of any kind, whether based upon warranty, contract, strict liability, negligence, o r a ny o ther ca use o f a ction, arising o ut o f th e sa le, u se, results of the use or inability to use product or its components. The foregoing shall apply, without limitation to losses of profits, business interruption, d amages t o p urchaser’s r eputation o r a ny o ther s uch damages. Limitation of Liability. With respect to any Company liability not legally subject to the foregoing terms, the Company's liability shall not exceed the amount paid by Purchaser to the Company for the Product.
BrainPort V100 User Manual 49 Appendix A Cleansers Wicab recommends that you clean the IOD once per week using t he cleansers listed in the table below. I f the cleanser is i n s olution, we t a c otton ball or c otton s wab and gently wipe the surfaces of the IOD. DO NOT SCRUB! Thoroughly rinse the I OD wi th tap wate r to re move any residual cleanser and allow it to air-dry. The cleansers listed below have been tested and shown to be compatible with the materials used in IOD. Follow the manufacturer’s directions regarding safe use and disposal for the cleanser. Please v isit o ur we bsite f or the m ost re cent l ist o f approved cleansers. Cleansers are add ed to the l ist as they are tested and shown to be compatible with the IOD. Cleanser Source 70% isopropyl alcohol (rubbing alcohol) Over the Counter (local pharmacy) May be in solution or as ‘wipes’ The IOD may be damaged by bleach or oxidizing agents. Do not use any product that contains chlorine, sodium hypochlorite, calcium hypochlorite, hydrogen peroxide, sodium percarbonate, sodium perborate, or similar chemical. Household bleach and over-the-counter whitening agents will damage the IOD.
BrainPort V100 User Manual 50 Appendix B Clinical Safety Information As described in Chapter 1, the BrainPort V100 was evaluated in a clinical study of 75 enrolled subjects. All adverse events reported, regardless of whether or not the events were related to the device, were captured in the study. The device-related adverse events are presented in Table A below. Throughout the 12 month study, a total of 28 device-related adverse events were reported in 18 subjects, but no clinically significant device-related adverse event occurred.
BrainPort V100 User Manual 51 Table A: Device-Related Adverse Events Reported with Use of the BrainPort V100 Device (n=75 Subjects) Type of Event Number of Events Events Allergic reaction NOT requiring medical care 3 Sinus Drainage Worsening Metallic Taste Suspected Metal Allergy Positively altered change in taste or numbness that is NOT sustained 2 Tingling sensation in mouth Hypergeusia (increased taste sensation) Negatively altered change in taste or numbness that is NOT sustained 13 Tongue sensitivity Taste of metal in mouth Dysgeusia while using device (metallic taste) Tingling on tongue Metallic taste while using the device Occasional hyposensitivity to taste after prolonged use Intermittent numbness in upper right dentition- canine and incisor Intermittent tingling sensation on tongue Increased sensitivity in teeth Increased tongue sensitivity Tongue stinging Mild sensitivity to teeth Soreness of tongue Other event related to health or condition not included in above categories 10 Increased tongue awareness Headache Increased salivation Small erythematous area on hard palate of mouth Small 2-3mm irritation in ridge- midline of mouth Headaches Clicking on right side of jaw Clicking of jaw (more on right than left) Headaches after prolonged use of device, intermittent Clicking of jaw bilaterally Note: S ome s tudy p articipants r eported m ore tha n 1 e vent; e ach e vent i s counted individually in the table above. The IOD component of the BrainPort V100 device has also been evaluated in patients with balance disorders in another device (Wicab Balance). The device-related safety data reported for this device are presented below. The Balance device is indicated for use in patients with
BrainPort V100 User Manual 52 balance disorders, and thus the reported adverse events may not be the same as those reported in the profoundly blind patients that were treated with the BrainPort V100 vision device. However, for a comprehensive evaluation of the device safety profile, all relevant available device-related safety data are presented in Table B (events reported during the clinical study of the Balance Device) below. Table B: Device-Related Adverse Events Reported with the BrainPort Balance Device – Controlled Clinical Trial (n=148 Users) Type of Event Events Number of Events Oral Conditions Tingling tongue 4 Dysgeusia 3 Tongue irritation 2 Cheilitis 2 Mouth ulcer 3 Burning tongue 1 Oral pain 1 Ear & Labyrinth Disorders Vertigo 4 Accident, Injury, And Procedural Complications Fall 3 Ankle sprain 1 Nervous System Disorders Migraine 1 Headache 1 Gastrointestinal Disorders Nausea 1 Psychiatric Disorders Concentration deficit 1
BrainPort V100 User Manual 53 User Assistance If you need assistance setting up, using or maintaining the BrainPort V100, or to report unexpected operation or events, please contact Wicab, Inc. by mail, telephone, or e-mail: North America Wicab, Inc. Attn: Customer Support 8313 Greenway Blvd. Suite 100 Middleton, WI 53562 USA Telephone: 1.608.829.4500 Fax: 1.608.829.4501 E-Mail: customersupportus@wicab.com Internet: www.wicab.com BrainPort is a trademark or registered trademark of Wicab, Inc. in the United States and other countries.
BrainPort V100 User Manual 54 0473 Correct Disposal of This Product (WEEE - Waste Electrical & Electronic Equipment) This marking on the product, accessories or literature indicates that the product and its electronic accessories should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the distributor where they purchased this product or their local government office for details of where and how they can take these items for environmentally safe recycling. Copyright 2014, Wicab, Inc. DR-001114 Rev D, January 2015

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