USER MANUAL
`
`BTTTM Headgear
`
`(
`
`for Sleep Optimization
`
`1
`
`The BTTTM Sleep Optimization Service monitors
`gour BTT signals to identifg and induce the restorative,
`protective and rejuvenative BTTTM Delta sleep
`
`.\
`
`BTT
`
`b-tt 0m HEADG EAR
`
`technologg bg
`M. Abreu M.D.
`
`'UCCOIOI.
`
`I........OO
`
`00.00.00.000.
`
`0000......0000000
`
`coco-OOOOIIOOOOQoo-
`
`

`

`Introducing
`The Headgear
`
`
`
`The BTTTM Headgear is part of the BTTTM Sleep Optimization Service and works in conjunction
`with the BTTTM Health application to optimize sleep and performance based on BTT
`thermodgnamic signals. signals from other sensors, and data provided bg user. The service
`collects and tracks data and shares it with a Service Provider, such as gour doctor, who gou
`choose and authorize to view gour data to help optimize your sleep, which as part of a
`healthg lifestgle mag help reduce the risk of cancer, Alzheimer's disease, Parkinsons's
`disease. amgotrophic lateral sclerosis (ALS) and other conditions.
`
`BTTTM Delta is the fundamental cerebral state that determines the brain's thermodynamic
`status for restorative sleep and removal of toxic waste from the brain that is associated
`with aging, Alzheimer's disease, Parkinsons’s disease, ALS and other disorders. Using our
`cloud-based technology and intelligent pattern detection, We assess the presence or
`absence of EiTTTM Delta, the level of BTTTM Delta and level of sleep fragmentation. We track
`dailg activities, habits, phgsiologg (eg. hydration level and bowel movements) and signals
`that are associated with generation of BTTTM Delta, and therefore, restorative, protective
`and rejuvenative sleep.
`
`We also provide an assessment report with activities. habits, and signals that generate or
`prevent BTTTM Delta. With this report, Service Providers can help clients optimize sleep and
`performance as well as reduce risk of diseases and retard aging.
`
`
`
`
`
`
`8T1"M Headgear i Sloop Optimization Service
`
`(
`
`

`

`
`
`Introducing
`The headgear
`
`Headgear
`
`Head straps
`
`a. Button
`b. Led
`c. USB
`d. Access to motion and light sensors
`e. Light diffuser
`f. Access to humiditg sensors
`9. Fiexibie arms (silicone)
`h. BTT sensor
`
`i. Veicro (hooks)
`
`j. VeLcro (Loops)
`k. Top fitting tape (ioops)
`l. Top fitting plastic buckte
`m. Back fitting tape [Loops]
`n. Back fitting plastic buckle
`
`
` 0
`
`(figure 7)
`
`Additional items on page 7 (USB cable, charger, USB flash drive and velvet pouch).
`
`
`
`x—%
`BTT'" Headgear i Sleep Optimization Service
`
`(
`
`

`

`BTTTM Headgear
`Sleep Optimization Service
`
`Keg functions
`
`
`
`oi Track dailg activities and habits that are associated with generation of BTT‘M Delta
`k.
`
`Track BTT thermodgnamic signals from the brain
`
`a Track signals from other sensors, such as heart rate monitor
`
`1 Assessment Report for Service Providers, such as gour doctor. with signal data, activities,
`and habits that generate or prevent BTT'M Delta
`
`Educational
`
`Section
`
`What is the BTT
`
`is a thermodgnamic
`(BTT)
`tunnel
`The brain thermal
`pathwag between the cavernous
`sinus around the
`hgpothalamic thermoregulatorg center and the fat free.
`thermallg conductive skin that overlies the egelid at the
`supero-medial orbit. This area between the age and the
`nose is referred to as the BTT site (see figure 2). This
`thermodynamic configuration provides direct transfer of
`thermal energg from inside
`of
`the brain without
`interference from elements, such as fat, which prevents
`heat
`transmission to the body's
`surface. The BTT‘M
`Headgear is designed to be positioned directlg above the
`left and right BTT sites to gather BTT thermodynamic
`signals.
`
`
`
`(figure 2)
`
`Where is the BTT Site
`
`
`BTT tunnels
`
`
`BTT Site
`
`
`
`
`1’figure 3)
`
`
`
`(
`
`BTT‘" Headgear I Sleep Optimization Service
`
`

`

`Setting up
`811‘“ Headgear
`
`
`
`1:. Download the BTT‘” Health App from the
`App Stone (105) or Gooqla Flag (Android).
`
`
`
`figure SJ
`
`n. Register uour BTT'" Health account I
`profile 5. Sign In to the BTT‘" Health App [see
`figure 6).
`
`
`I!
`“mgr
`.I t
`
`rwr
`
`
`
`I'M»! 7)
`
`c. In new first access. please Install and
`sync the BIT“ Headgear wlth the APP. (see
`figure 7).
`
`2. Waring the ITT" Huang lit
`
`.437
`
`m 3)
`
`figure 9)
`
`a. Attaching the headgear to the head
`strap [see than: a and 9].
`Ana-.- Malm sum the Velcro ls seturllg fastened.
`
`!
`
`/\_,
`
`ITF‘HIidglari Sleep Optimlzatlon Service
`
`0. Pull the head strap Inside out
`(see figure 10}.
`
`‘\
`
`
`
`
`\
`”we l 1‘!
`
`c. Place the haedgoar to your forehead with
`the amen on the an slta tor inltlal
`admment of tha mr arms length (see
`
`figure 11).
`f
`
`

`

`Setting up
`BTTrM Headgear
`
`3. Sensor arm length adjustment
`
`4. Adjusting the straps
`
`1.!"
`
`(figure i2)
`
`0. Pull or push the silicone arms slightly
`(see figure 12) and individuallg (one at a
`time) to position the sensor.
`A note: if you are not sure about the positioning,
`Visit the “Where is the BTT site " section on page 3.
`
`
`
`.5
`‘
`
`figure 13}
`
`(figure 14)
`
`b. Test the position. Repeat the process until
`gou get a correct fitting (see figure IB/M).
`A note: The portion sensor should necessarily touch
`the skin, but gently so that comfort is not
`compromised.
`
`
`
`(figure 75,)
`
`a. Adjust the bands of the neck and top of
`the head through the plastic buckles (see
`figure 16).
`A note: Secure the straps to the head and make
`sure that sensor portion is resting on the skin at
`the BTT site, but avoid tightening the bands too
`much on the back and top of the head.
`
`if I
`
` (figure 75)
`
`c. When you see the safety mark. stop
`pulling on the silicone, as it indicates the
`end of the path (see figure 15).
`
`A, note: Be careful not do exceed the specified
`limits, because that may damage the sensor
`connections.
`
`(figure 77)
`
`b. In the case of long hair, pull the hair up
`between the two bands (see figure 17).
`
`\‘_——
`(
`BTT“‘I Headgear i Sleep Optimization Servxce
`
`

`

`
`
`Setting up
`BTTTM Headgear
`
`5. Sensor positioning
`
`
`
`{figure 78)
`
`a. Before starting moniroting make sure the BTT‘M Headgear is centered and fixed on gour head
`(see figure 18).
`
`6. Start Monitoring
`
`When using the BTTTM headgear for the first time, gou need to pair the device with gour phone.
`For more information on pairing, see section “Getting started" on the page 04.
`
`
`
`(figure i9)
`
`(figure 20)
`
`{figure 2i)
`
`(figure 22}
`
`(figure 23)
`
`{figure 24}
`
`a. Open the BTTTM Health app and go to the sleep monitoring (0) section [see figure 19).
`
`b. Press the button (see figure 20) on the headgear and select the Setup Monitoring on App.
`
`c. Turn on the device selecting the button ( O) in the app (see figure 21].
`
`d. When the green light blinks (see figure 22). press the Start Monitoring on App (see figure 23)‘
`9. You are readg to monitor gour BTT signal (see figure 24).
`
`
`
`i
`
`BTTm Headgear | Sleep Optimization Service
`
`

`

`Cleaning
`And Storage
`
`Cleaning the head strap
`
`(figure 25)
`
`(figure 25)
`
`fl
`t 7
`Hand
`wash
`
`><
`Do not
`W
`tugble
`
`
`
`
`
`; x ‘
`>O<
`7
`[)0 not
`Drg in
`bleach
`the shade
`
`I
`"
`7‘.
`c - l X
`Do not
`Do not
`
`Iran
`(figure 27)
`
`drgclean
`
`0. Remove the headgear from the head strap bg pulling it off the Velcro on the head strap
`(see figure 25].
`
`A note: Only the head strap can be washed (see figure 25).
`& note: Follow the washing instructions (see figure 27).
`
`Cleaning the sensor lenses
`
`
`
`{figure 28)
`
`0. Use a cotton swab dipped in isopropgl alcohol (70% or above) to clean the probe lens (see
`figure 28). Repeat the process for the other lens.
`
`A note: The probe lens is the most delicate part of the headgear. Use care when cleaning the probe lens to avoid
`damage.
`A note: Avoid getting your headgear device wet in order to avoid permanent damage to electronics and sensor
`parts.
`
`Headgear storage
`
`
`
`.fgureh29) (xi(figure30)
`
`0. Use the velvet bag to store your headgear (see figure 29), and the other parts [see figure 30).
`A note: Keep it stored in dry place and at room temperature.
`
`/—¥
`
`BTT'“ Headgear | Sleep Optimization Service
`
`(
`
`

`

`Charglng the
`Batterg
`
`.
`
`I
`
`D 0% .
`
`
`
`100%
`
`[m 5?)
`
`(may;
`
`(Faun 33}
`
`a. When the hams-u discharws (sea figure 311, plug the U53 charger lam rho headmar [we
`figure 32) and wait fur the battery to mun charge {see figure 33}
`& nan-Donarm than-rm uflbdmm ch. battery. TM mommrmgfomurc wit bodamolodmw
`dam 5mm m murmur scarce
`
`Headgear
`Specificatlons
`
`d Tampermzure measumment range: 93.2"!2 - WE'F ENC - All?)
`
`0' Operating temperature range: SD'F - th'F {IO'C- 60C). :55 - 85% RH
`
`' Storage mmpcrature rangu: Start at room temperature banner: -"F- 322* (-ZO'C
`50°CLRH 35%. Transportation «murmur! should be has man TSS'F. RH 95%
`
`I Armorial: prmuru: mm» 1013 hPa
`
`C (amid!!! with ASTM E1965.“ EN ISO Mid-55. lEC/ENEIOED‘I-l-KEHC].
`WENW‘I-thltu] standards ISOIOQQB, ROI-t5
`
`I Input: 1:33-sz ~ 1001M
`50-60“: mom
`
`I Saturn Ufa Cum: ~ 500 charges
`
`U RGB it!)
`
`I Dimmflan: 72mm x 115mm x 35mm (h x lx a)
`
`0 Weight: 55g (2 oz.)
`
`

`

`Terms
`
`And conditions
`
`
`
`
`
`
`
`
`The BTTTM SLEEP OPTIMIZATION SERVICE is intended for wellness purposes only and is not
`intended for use in the diagnosis of disease or other conditions, or in the cure. mitigation,
`treatment, or prevention of disease. Service is not intended for use in the detection.
`diagnosis, monitoring, management, or treatment of any medical condition, disease, or
`vital physiological process or for the transmission of time-sensitive health information.
`
`
`
`Any information found, acquired, or accessed through the BTTT“ HEALTH APPLICATION and
`the BTT'M HEADGEAR is made available only for your convenience and should not be
`treated as medical advice. You Should seek medical advice from a doctor before starting
`
`
`a wellness or lifestyle regimen. You understand and agree that any information you
`
`
`obtain from the BTTTM SLEEP OPTIMIZATION SERVICE may not be suitable, accurate,
`
`
`complete, or reliable and that BTTTM CORP. will not be held liable for any injuries,
`
`
`damages, losses and/or costs associated with the BTTTM SLEEP OPTIMIZATION SERVICE, nor
`
`
`for the accuracy or reliability of any information found, acquired. or accessed through the
`
`
`BTTTM SLEEP OPTIMIZATION SERVICE. You acknowledge and agree that BTT1M CORP.
`is not
`
`
`engaged in the practice of medicine and that BTTTM CORP does not determine the
`appropriate medical use of the BTTTM SLEEP OPTIMIZATION SERVICE.
`
`
`
`
`No changes
`
`ETT'” Corp has not approved any changes or modi cations to this device by the user. Any changes or modi cations
`could void the user’s authority to operate the equipment and may cause harm.
`
`FCC Regulatory information
`
`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.
`
`ACaution: Any Changes or modifications not
`expressly approved by the party responsible
`for compliance could void the user's authority
`
`to operate the equipment.
`
`Note: This equipment has been tested and found to
`comply with the limits for a Class B 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
`
`EBIuetnoth" F©
`
`If this equipment does cause
`particular installation.
`harmful interference to radio or television reception,
`which can be determined by turning the equipment off
`and on. the user is encouraged to try to correct the
`interference by one or more of the following measures:
`1. Reorient or relocate the receiving antenna.
`2. Increase the separation between the equipment
`and receiver.
`3. Connect the equipment into an outlet on a circuit
`different from that to which the receiver is
`connected.
`4. Consult the dealer or an experienced radio/ TV
`technician for help.
`
`This product emits radio frequency energy. but the
`radiated output power of this device is far below the
`FCC radio frequency exposure limits. This equipment
`complies with FCC RF radiation exposure limits forth
`for an uncontrolled environment.
`
`Protected by U5. Patents 7187960, 9011349, 9398856
`9301719, 94085 72, 944576 7, 7787960. 8849379.
`8328420, 8721562, 8834020, 8172459. 9119530 and
`other Patents Pending (U5. and international)
`
`
`LBTT'" Headgear | Sleep Optimization Service
`
`

`

`b-t-t 0"“
`
`Brain Tunnelgenix Technologies (BTT) Corp
`17501 Biscagne Blvd, Suite 470
`Aventura. FL 33160
`
`info@bttcorp.com
`
`@
`c3)
`
`
`
`-|OOI......IOI-
`
`o.............o-
`
`0000.00.00.00...
`
`00..........OOOO
`
`

`

`USER MANUAL
`
`BTTTM Headgear
`
`(
`
`for Sleep Optimization
`
`1
`
`The BTTTM Sleep Optimization Service monitors
`gour BTT signals to identifg and induce the restorative,
`protective and rejuvenative BTTTM Delta sleep
`
`.\
`
`BTT
`
`b-tt 0m HEADG EAR
`
`technologg bg
`M. Abreu M.D.
`
`'UCCOIOI.
`
`I........OO
`
`00.00.00.000.
`
`0000......0000000
`
`coco-OOOOIIOOOOQoo-
`
`

`

`Introducing
`The Headgear
`
`
`
`The BTTTM Headgear is part of the BTTTM Sleep Optimization Service and works in conjunction
`with the BTTTM Health application to optimize sleep and performance based on BTT
`thermodgnamic signals. signals from other sensors, and data provided bg user. The service
`collects and tracks data and shares it with a Service Provider, such as gour doctor, who gou
`choose and authorize to view gour data to help optimize your sleep, which as part of a
`healthg lifestgle mag help reduce the risk of cancer, Alzheimer's disease, Parkinsons's
`disease. amgotrophic lateral sclerosis (ALS) and other conditions.
`
`BTTTM Delta is the fundamental cerebral state that determines the brain's thermodynamic
`status for restorative sleep and removal of toxic waste from the brain that is associated
`with aging, Alzheimer's disease, Parkinsons’s disease, ALS and other disorders. Using our
`cloud-based technology and intelligent pattern detection, We assess the presence or
`absence of EiTTTM Delta, the level of BTTTM Delta and level of sleep fragmentation. We track
`dailg activities, habits, phgsiologg (eg. hydration level and bowel movements) and signals
`that are associated with generation of BTTTM Delta, and therefore, restorative, protective
`and rejuvenative sleep.
`
`We also provide an assessment report with activities. habits, and signals that generate or
`prevent BTTTM Delta. With this report, Service Providers can help clients optimize sleep and
`performance as well as reduce risk of diseases and retard aging.
`
`
`
`
`
`
`8T1"M Headgear i Sloop Optimization Service
`
`(
`
`

`

`
`
`Introducing
`The headgear
`
`Headgear
`
`Head straps
`
`a. Button
`b. Led
`c. USB
`d. Access to motion and light sensors
`e. Light diffuser
`f. Access to humiditg sensors
`9. Fiexibie arms (silicone)
`h. BTT sensor
`
`i. Veicro (hooks)
`
`j. VeLcro (Loops)
`k. Top fitting tape (ioops)
`l. Top fitting plastic buckte
`m. Back fitting tape [Loops]
`n. Back fitting plastic buckle
`
`
` 0
`
`(figure 7)
`
`Additional items on page 7 (USB cable, charger, USB flash drive and velvet pouch).
`
`
`
`x—%
`BTT'" Headgear i Sleep Optimization Service
`
`(
`
`

`

`BTTTM Headgear
`Sleep Optimization Service
`
`Keg functions
`
`
`
`oi Track dailg activities and habits that are associated with generation of BTT‘M Delta
`k.
`
`Track BTT thermodgnamic signals from the brain
`
`a Track signals from other sensors, such as heart rate monitor
`
`1 Assessment Report for Service Providers, such as gour doctor. with signal data, activities,
`and habits that generate or prevent BTT'M Delta
`
`Educational
`
`Section
`
`What is the BTT
`
`is a thermodgnamic
`(BTT)
`tunnel
`The brain thermal
`pathwag between the cavernous
`sinus around the
`hgpothalamic thermoregulatorg center and the fat free.
`thermallg conductive skin that overlies the egelid at the
`supero-medial orbit. This area between the age and the
`nose is referred to as the BTT site (see figure 2). This
`thermodynamic configuration provides direct transfer of
`thermal energg from inside
`of
`the brain without
`interference from elements, such as fat, which prevents
`heat
`transmission to the body's
`surface. The BTT‘M
`Headgear is designed to be positioned directlg above the
`left and right BTT sites to gather BTT thermodynamic
`signals.
`
`
`
`(figure 2)
`
`Where is the BTT Site
`
`
`BTT tunnels
`
`
`BTT Site
`
`
`
`
`1’figure 3)
`
`
`
`(
`
`BTT‘" Headgear I Sleep Optimization Service
`
`

`

`Setting up
`811‘“ Headgear
`
`
`
`1:. Download the BTT‘” Health App from the
`App Stone (105) or Gooqla Flag (Android).
`
`
`
`figure SJ
`
`n. Register uour BTT'" Health account I
`profile 5. Sign In to the BTT‘" Health App [see
`figure 6).
`
`
`I!
`“mgr
`.I t
`
`rwr
`
`
`
`I'M»! 7)
`
`c. In new first access. please Install and
`sync the BIT“ Headgear wlth the APP. (see
`figure 7).
`
`2. Waring the ITT" Huang lit
`
`.437
`
`m 3)
`
`figure 9)
`
`a. Attaching the headgear to the head
`strap [see than: a and 9].
`Ana-.- Malm sum the Velcro ls seturllg fastened.
`
`!
`
`/\_,
`
`ITF‘HIidglari Sleep Optimlzatlon Service
`
`0. Pull the head strap Inside out
`(see figure 10}.
`
`‘\
`
`
`
`
`\
`”we l 1‘!
`
`c. Place the haedgoar to your forehead with
`the amen on the an slta tor inltlal
`admment of tha mr arms length (see
`
`figure 11).
`f
`
`

`

`Setting up
`BTTrM Headgear
`
`3. Sensor arm length adjustment
`
`4. Adjusting the straps
`
`1.!"
`
`(figure i2)
`
`0. Pull or push the silicone arms slightly
`(see figure 12) and individuallg (one at a
`time) to position the sensor.
`A note: if you are not sure about the positioning,
`Visit the “Where is the BTT site " section on page 3.
`
`
`
`.5
`‘
`
`figure 13}
`
`(figure 14)
`
`b. Test the position. Repeat the process until
`gou get a correct fitting (see figure IB/M).
`A note: The portion sensor should necessarily touch
`the skin, but gently so that comfort is not
`compromised.
`
`
`
`(figure 75,)
`
`a. Adjust the bands of the neck and top of
`the head through the plastic buckles (see
`figure 16).
`A note: Secure the straps to the head and make
`sure that sensor portion is resting on the skin at
`the BTT site, but avoid tightening the bands too
`much on the back and top of the head.
`
`if I
`
` (figure 75)
`
`c. When you see the safety mark. stop
`pulling on the silicone, as it indicates the
`end of the path (see figure 15).
`
`A, note: Be careful not do exceed the specified
`limits, because that may damage the sensor
`connections.
`
`(figure 77)
`
`b. In the case of long hair, pull the hair up
`between the two bands (see figure 17).
`
`\‘_——
`(
`BTT“‘I Headgear i Sleep Optimization Servxce
`
`

`

`
`
`Setting up
`BTTTM Headgear
`
`5. Sensor positioning
`
`
`
`{figure 78)
`
`a. Before starting moniroting make sure the BTT‘M Headgear is centered and fixed on gour head
`(see figure 18).
`
`6. Start Monitoring
`
`When using the BTTTM headgear for the first time, gou need to pair the device with gour phone.
`For more information on pairing, see section “Getting started" on the page 04.
`
`
`
`(figure i9)
`
`(figure 20)
`
`{figure 2i)
`
`(figure 22}
`
`(figure 23)
`
`{figure 24}
`
`a. Open the BTTTM Health app and go to the sleep monitoring (0) section [see figure 19).
`
`b. Press the button (see figure 20) on the headgear and select the Setup Monitoring on App.
`
`c. Turn on the device selecting the button ( O) in the app (see figure 21].
`
`d. When the green light blinks (see figure 22). press the Start Monitoring on App (see figure 23)‘
`9. You are readg to monitor gour BTT signal (see figure 24).
`
`
`
`i
`
`BTTm Headgear | Sleep Optimization Service
`
`

`

`Cleaning
`And Storage
`
`Cleaning the head strap
`
`(figure 25)
`
`(figure 25)
`
`fl
`t 7
`Hand
`wash
`
`><
`Do not
`W
`tugble
`
`
`
`
`
`; x ‘
`>O<
`7
`[)0 not
`Drg in
`bleach
`the shade
`
`I
`"
`7‘.
`c - l X
`Do not
`Do not
`
`Iran
`(figure 27)
`
`drgclean
`
`0. Remove the headgear from the head strap bg pulling it off the Velcro on the head strap
`(see figure 25].
`
`A note: Only the head strap can be washed (see figure 25).
`& note: Follow the washing instructions (see figure 27).
`
`Cleaning the sensor lenses
`
`
`
`{figure 28)
`
`0. Use a cotton swab dipped in isopropgl alcohol (70% or above) to clean the probe lens (see
`figure 28). Repeat the process for the other lens.
`
`A note: The probe lens is the most delicate part of the headgear. Use care when cleaning the probe lens to avoid
`damage.
`A note: Avoid getting your headgear device wet in order to avoid permanent damage to electronics and sensor
`parts.
`
`Headgear storage
`
`
`
`.fgureh29) (xi(figure30)
`
`0. Use the velvet bag to store your headgear (see figure 29), and the other parts [see figure 30).
`A note: Keep it stored in dry place and at room temperature.
`
`/—¥
`
`BTT'“ Headgear | Sleep Optimization Service
`
`(
`
`

`

`Charglng the
`Batterg
`
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`
`I
`
`D 0% .
`
`
`
`100%
`
`[m 5?)
`
`(may;
`
`(Faun 33}
`
`a. When the hams-u discharws (sea figure 311, plug the U53 charger lam rho headmar [we
`figure 32) and wait fur the battery to mun charge {see figure 33}
`& nan-Donarm than-rm uflbdmm ch. battery. TM mommrmgfomurc wit bodamolodmw
`dam 5mm m murmur scarce
`
`Headgear
`Specificatlons
`
`d Tampermzure measumment range: 93.2"!2 - WE'F ENC - All?)
`
`0' Operating temperature range: SD'F - th'F {IO'C- 60C). :55 - 85% RH
`
`' Storage mmpcrature rangu: Start at room temperature banner: -"F- 322* (-ZO'C
`50°CLRH 35%. Transportation «murmur! should be has man TSS'F. RH 95%
`
`I Armorial: prmuru: mm» 1013 hPa
`
`C (amid!!! with ASTM E1965.“ EN ISO Mid-55. lEC/ENEIOED‘I-l-KEHC].
`WENW‘I-thltu] standards ISOIOQQB, ROI-t5
`
`I Input: 1:33-sz ~ 1001M
`50-60“: mom
`
`I Saturn Ufa Cum: ~ 500 charges
`
`U RGB it!)
`
`I Dimmflan: 72mm x 115mm x 35mm (h x lx a)
`
`0 Weight: 55g (2 oz.)
`
`

`

`Terms
`
`And conditions
`
`
`
`
`
`
`
`
`The BTTTM SLEEP OPTIMIZATION SERVICE is intended for wellness purposes only and is not
`intended for use in the diagnosis of disease or other conditions, or in the cure. mitigation,
`treatment, or prevention of disease. Service is not intended for use in the detection.
`diagnosis, monitoring, management, or treatment of any medical condition, disease, or
`vital physiological process or for the transmission of time-sensitive health information.
`
`
`
`Any information found, acquired, or accessed through the BTTT“ HEALTH APPLICATION and
`the BTT'M HEADGEAR is made available only for your convenience and should not be
`treated as medical advice. You Should seek medical advice from a doctor before starting
`
`
`a wellness or lifestyle regimen. You understand and agree that any information you
`
`
`obtain from the BTTTM SLEEP OPTIMIZATION SERVICE may not be suitable, accurate,
`
`
`complete, or reliable and that BTTTM CORP. will not be held liable for any injuries,
`
`
`damages, losses and/or costs associated with the BTTTM SLEEP OPTIMIZATION SERVICE, nor
`
`
`for the accuracy or reliability of any information found, acquired. or accessed through the
`
`
`BTTTM SLEEP OPTIMIZATION SERVICE. You acknowledge and agree that BTT1M CORP.
`is not
`
`
`engaged in the practice of medicine and that BTTTM CORP does not determine the
`appropriate medical use of the BTTTM SLEEP OPTIMIZATION SERVICE.
`
`
`
`
`No changes
`
`ETT'” Corp has not approved any changes or modi cations to this device by the user. Any changes or modi cations
`could void the user’s authority to operate the equipment and may cause harm.
`
`FCC Regulatory information
`
`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.
`
`ACaution: Any Changes or modifications not
`expressly approved by the party responsible
`for compliance could void the user's authority
`
`to operate the equipment.
`
`Note: This equipment has been tested and found to
`comply with the limits for a Class B 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
`
`EBIuetnoth" F©
`
`If this equipment does cause
`particular installation.
`harmful interference to radio or television reception,
`which can be determined by turning the equipment off
`and on. the user is encouraged to try to correct the
`interference by one or more of the following measures:
`1. Reorient or relocate the receiving antenna.
`2. Increase the separation between the equipment
`and receiver.
`3. Connect the equipment into an outlet on a circuit
`different from that to which the receiver is
`connected.
`4. Consult the dealer or an experienced radio/ TV
`technician for help.
`
`This product emits radio frequency energy. but the
`radiated output power of this device is far below the
`FCC radio frequency exposure limits. This equipment
`complies with FCC RF radiation exposure limits forth
`for an uncontrolled environment.
`
`Protected by U5. Patents 7187960, 9011349, 9398856
`9301719, 94085 72, 944576 7, 7787960. 8849379.
`8328420, 8721562, 8834020, 8172459. 9119530 and
`other Patents Pending (U5. and international)
`
`
`LBTT'" Headgear | Sleep Optimization Service
`
`

`

`b-t-t 0"“
`
`Brain Tunnelgenix Technologies (BTT) Corp
`17501 Biscagne Blvd, Suite 470
`Aventura. FL 33160
`
`info@bttcorp.com
`
`@
`c3)
`
`
`
`-|OOI......IOI-
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`
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`
`

`

`BTT HEA T SHOCK TECHNOLOGIES LLC
`
`INFORMED CONSENT and
`
`AUTHORIZATION FOR PROCEDURE
`
`THERMAL MODULATION
`
`b-t-t 0“"
`
`Protect preserve and proLong Life
`
`

`

`BTT HEAT SHOCK TECHNOLOGIES LLC
`
`INFORMED CONSENT and AUTHORIZATION FOR PROCEDURE
`
`BRAIN COOLING using THERMAL MODULATION
`
`TO THE PATIENT, MRS. xxxxxxxx, you have the right, as a patient, to be informed about your
`condition and the recommended surgical, medical or diagnostic procedure to be used, so that
`you may make the decision whether or not to undergo the procedure after knowing the risks
`and hazards involved. This disclosure is not meant to scare or alarm you; it is simply an effort to
`
`make you better informed so you may give or withhold your consent for this procedure.
`
`I, XXXXXXXXX voluntarily request, Dr. M. MARC ABREU, MD. as my physician, and such
`associated physicians, and other assistants and other health care providers and technical
`providers as he may deem necessary, to treat my condition, which has been explained to my
`satisfaction in layman‘s terms.
`
`Diagnosis: You have a condition known as Multiple Sclerosis (”MS”).
`
`I, xxxxxxxxx, understand that the following procedure is planned
`Explanation of Procedure:
`for me, and I voluntarily consent and authorize this procedure (in lay terms), referred herein
`as ”Procedure”: EXPOSURE OF MY ENTIRE BODY AND MY HEAD, TO A VERY LOW TEMPERATURE,
`WITH CONTINUOUS MONITORING OF MY BRAIN THERMAL TUNNEL TEMPERATURE USING A
`NONINVASIVE SENSOR THAT IS POSITION ED ON THE SKIN OF MY EYELID BETWEEN MY EYE AND
`NOSE. THE PROCEDURE MAY INVOLVE VERY LOW BODY AND BRAIN TEMPERATURE AND I MAY
`FEEL VERY COLD AND MAY SHIVER. COLD DELIVERY TO MY BODY WILL BE MONITORED
`CONTINUOUSLY AND CONTROLED BY A SIGNAL COMING FROM A SENSOR IN MY BRAIN
`THERMAL TUNNEL. THE TEMPERATURE OF PROBES ON MY BODY WILL BE ALSO MONITORED
`CONTINUOUSLY AND CONTROLLED BY A SIGNAL FROM THE BRAIN THERMAL TUNNEL
`ACCORDING TO THE SETTINGS PRESCRIBED DURING THE PROCEDURE BY THE TREATING
`PHYISICIAN. THE OBJECTIVE OF THE PROCEDURE IS TO INDUCE MYELIN FORMATION AND
`REDUCE HARMFUL INFLAMMATORY ACTIVITY. There will be a total of 1 Procedure. The
`
`procedure may include a pre—induction and post—induction phases, which includes reducing your
`temperature before and after your body being exposed to low temperature. The whole—body
`brain cooling procedure will occur after blood is drawn from my arm or hand, and after
`placement ofan intravenous access line. Blood will be drawn several times after each procedure
`according to the prescription by the treating physician.
`
`Prior to treatment Mrs. Xxxxxxxxx may receive 300 cc to 1 liter of water or water/electrolyte as
`determined by treating physician, however the decision to ingest fluids orally or by intravenous
`injection relies on the treating, who may elect not to administer fluids, based on the clinical
`condition, such as, but not limited to, the cardiovascular and respiratory status of the patient.
`
`Patient Initials:
`
`Witness Initials:
`
`2
`
`

`

`Mrs. Xxxxxxxxx may have IV line and may receive 1.0 L intravenous (IV) 5% dextrose in 0.25
`normal saline or Ringer Lactate per treatment session, according to prescription by physician
`overseeing treatment. However, administration of fluids may vary and will be dependent on
`clinical evaluation at the time of the procedure.
`
`Duration of session will be determined by treating physician depending on clinical condition and
`therapeutic effect. A series of blood drawn for measuring heat shock proteins may be necessary
`for each operation.
`
`Observation period: Mrs. Xxxxxxxxx will be placed in a recovery room and may be observed for
`1 hour or longer as determined by treating physician.
`
`It must be noted that BTT Heat Shock Technologies is specialized only in treatment by thermal
`modulation and it is not equipped to provide medical care or overnight stay, and it does not
`offer or have in—patient rooms, and it does not offer stay beyond the observation period post
`treatment.
`
`Tests to measure muscle strength and other measurements may be used before and after the
`Procedure.
`
`I understand that my physicianis) may discover other different conditions which may require
`additional or different procedures than those planned. I authorize my physician, and said such
`associates,
`technical assistants and other health care providers to perform such other
`procedures, which are advisable in their professional judgment.
`
`No Guarantee and Research Disclosure: I understand that NO WARRANTY OR GUARANTEE OF
`
`ANY TYPE has been made to me as to the result or benefit ofthis Procedure or anticipated care,
`and that my condition may progress at the current rate or faster rate than before the procedure,
`and that there may be no clinical benefit.
`I understand that my results may be used in a
`published research study without my name being identified or without additional prior consent.
`I understand that photographs will be taken and that there will be video recording of the entire
`time that I am at the medical facility where I am receiving care, and that I explicitly grant
`permission to BTT Heat Shock Technologies, LLC (and any of its associated companies) and any
`scientific journal to publish my data and the photos of my body including my face, except any
`naked pictures,
`in all formats (print and digital) including online publication.
`In addition,
`I
`understand that I will be tracked by a treatment registry run by the BTT Heat Shock Technologies
`LLC, where I am receiving care. This will include someone contacting me (or a family member)
`via e—mail or phone, my filling out questionnaires, answering questions, and the like, at certain
`times and that this is planned to continue for a period of 12 months.
`
`Possible Side Effects of Procedure: Just as there may be risks and hazards in continuing my
`present condition without
`treatment,
`there are also risks and hazards related to the
`performance of the medical and/or diagnostic procedures planned for me. I realize that general
`risks of all procedures of this type are skin freezing, rapid heart rate, rapid respiratory rate,
`Patient initials:
`Witness initials:
`
`

`

`shortness of breath, renal damage, liver damage, blood clots, allergic reaction, or even death. I
`also realize the following hazards may occur in connection with this particular Procedure: 1.
`Nausea and vomiting, 2. Bruising/bleeding at the site of injection and vein access line, 3.
`Infection at the site of the injection and vein access line, 4. Celiulitis at the vein site. 5. Allergic
`drug reaction, 6. Numbness, 7. Discomfort due to low temperature, 8. Increase in blood
`pressure, 9. Loss of consciousness, 10. Abnormal heartbeat, 11. Vomiting and possible
`aspiration, 12. Kidney failure, 13. Liver failure, 14. Paralysis, 15. Weight loss, 16. Nerve injury,
`17. Brain damage, and 18. Coma. The above risks and complications ARE NOT THE ONLY
`POSSIBLE SIDE EFECTS AND RISKS. The treatment or procedure may involve risks that are
`currently unforeseeable, and side effects include death.
`
`Possible Side Effects of Sedation [if any): I understand that I can elect to have sedation and that
`it involves additional risks and hazards. Sedation or anesthesia means that I will be given a vein
`injection of medication or a numbing injection or both. I realize the sedation may have to be
`given, possibly without explanation to me, depending on my thermal tolerance, body weight,
`and stress level. I understand that certain complications m