FEEL THE POWER OF PULSETTO

There is no prior mindfulness or meditation experience required. Benefits to your well-

being are cumulative with regular sessions and are effective from the first time you use your
Pulsetto.

OUR STORY
The purpose of Pulsetto is to provide stress resilience and well-being to people from
all walks of life by utilizing effective methodologies and cutting-edge technology.
Based on decades of expertise working with stress and trauma-related conditions, we
are bringing to the mainstream market a vagus nerve stimulation technology that will enable
customers to treat conditions such as stress, poor sleep, and anxiety.
We are a small team working hard to bring Pulsetto to as many people as possible –
your support and assistance are really appreciated, so please stay in touch or even leave a 5-
star rating in the App Store or Google Play if you're enjoying your sessions.

Before that – make the most of your sessions

▪ Set aside some uninterrupted time – even 10 to 15 minutes is sufficient.

▪ To avoid notifications, set your phone to sleep or do-not-disturb mode.
▪ Put Pulsetto on your neck and adjust the size to keep it in place.
▪ Make sure Bluetooth is turned on, begin your session using the app, then relax...
What should you expect after a session?

Even if Pulsetto works from the first session, the long-term effects are cumulative and
can vary. When you're finished, move gently and carefully as you become a better version of
yourself! Pulsetto affects everyone differently; however, the most frequent long-term outcomes
people describe are:
▪ improved sleep length and quality
▪ improved mood and anxiety lowered
▪ increased resilience to stress
We advocate keeping an open mind – and please let us know what changes you see along
the way; we'd love to hear from you.

GETTING STARTED

Using your smartphone, search for ‘Pulsetto‘ in the App Store (iPhone) or
Google Play (Android) and install the app. After downloading, open the app
and follow the instructions to complete your setup.

1. Make sure that Bluetooth and location services are enabled on your phone, and the
phone is near the ‘Pulsetto’ device.
2. Please view the tutorial and follow the instructions in the Application.
3. Sign up to the application. If it is your first time, you will have to sign up to the
Pulsetto application to become a Pulser.
4. When you first log in, you will see the tutorial messages. Later, you can find them on
the "Settings" page under “Tutorial.”
5. Remove any jewelry that may touch the session location.
 6. Find a comfortable sitting position. (A place where you can see your neck in the
mirror may be helpful.)
7. Make sure the session location is clean and dry.
8. Apply gel to the neck region. Apply on both sides.
9. Put the Pulsetto device on your neck and check if
electrodes are on the site where you applied the gel. Not
applying the gel as described may cause the stimulation
to be uncomfortable or less effective.
10. Turn Pulsetto on by pressing the power button on the
device. You will see a green LED indication around the
button.
11. You will see the available programs on our applications on
the home screen. You can read more on the settings page.
12. Position the device in the correct place on the
neck over the session location. Adjust the collar
dimension to feel mild to moderate pressure, so the
device makes good contact with the skin; however, do
not apply excessive pressure to the neck.
13. Select the program. You will see more
instructions on the program screen.
14. Increase the intensity level in the application to
the comfortable level you can tolerate. Once you have
found your preferred intensity level, just enjoy your
remaining session! You will likely feel muscle
contractions at
the session
location. These
muscle
contractions are
normal and
should stop after the stimulation is complete.
The appropriate intensity level differs for every
person and may vary from stimulation to
stimulation.

15. Following the session, you will have the ability to rate
your session and view session details. Your profile has all of
this information. This will also help us create a better user
experience!

NOTE: You can always check your previous sessions

and preferences in your profile to check the programs. And
Pulsate even more!

NOTE: Neck muscle contractions that are not painful

during the stimulation are normal and not a reason to stop
the stimulation. If muscle contractions are too strong or
uncomfortable, try:

▪ Removing Pulsetto from the neck.

▪ Lowering the intensity level by pressing the bottom area
of the control button.
 ▪ Repositioning the Pulsetto on the neck over the pulse and slowly increasing the
intensity level again by pressing the top area of the control button.
▪ If the stimulation is still intolerable, turn the device off by pressing and holding the
power button and discontinue the stimulation.

Clean Pulsetto by wiping the leftover gel off the stimulation surfaces with a soft, dry cloth.
Clean the excess gel off your neck with a cloth or tissue. The gel is not intended to be left on
the skin and may cause skin irritation for some people.

INDICATIONS AND PRODUCT DESCRIPTION

Pulsetto (non-invasive vagus nerve stimulator) is indicated for:
▪ Stress reduction
▪ Coping with anxiety
▪ Improving sleep
Pulsetto provides a mild electrical stimulation to the vagus nerve, which runs through
the neck and carries information to the central nervous system. According to your selected
program, each stimulation with Pulsetto lasts from 1 to 15 minutes. You can always add a
couple of additional minutes.
The user controls the intensity level and duration.
Pulsetto is supplied non-sterile.

Device Feature Description / Use

Points of contact with the
Stimulation Surfaces patient’s skin
Power Button Turns power ON/OFF
Adjustable sliding mechanism Allows User to adjust the size
Charging cable Charges the device

Functions:
 Power Button

Press the power button to turn the device ON

Hold the power button to turn the device OFF

LED display symbols:

Icon Description LED indicator Description

Glowing blue light Device is booting

Glowing green light The device is ready for pairing

Blinking purple colors The session started.

Glowing red light Charging.

Charging Instructions:

1. Plug the USB-C cable into the device charging point. Connect the other end of the
USB-C cable to the power outlet minimum requirement of 0.5A.
2. The device LED will glow RED color while charging.

Cleaning:
▪ Clean the device after each use by gently wiping the case and the stimulation surfaces
with a soft, dry cloth to remove the leftover gel.
▪ Put the cap back on the device after use to protect the stimulation surfaces from dirt,
debris, and damage.
COMMON SIDE EFFECTS ASSOCIATED WITH PULSETTO
The most common side effects include:
▪ Application site discomfort
▪ Application site irritation/redness
▪ Local pain, face/head/neck area (including toothache)
▪ Muscle twitching and/or contractions, face/head/neck area (including facial droop
and/or lip pull)
▪ Headache/migraine
▪ Dizziness
▪ Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is
applied (paresthesia/dysesthesia)
▪ These side effects typically resolve immediately after the stimulation is complete.
CONTRAINDICATIONS
Contraindications include but are not limited to:
▪ Users with an active implantable medical device, such as a pacemaker, hearing aid
implant, or any implanted electronic device
▪ Users with a metallic device such as a stent, bone plate, or bone screw implanted at
or near their neck
▪ Users who are using another device at the same time (e.g., TENS Unit, muscle
stimulator) or any portable electronic device (e.g., mobile phone)

Users should not use Pulsetto:

▪ While driving, operating machinery, or during any activity that may put the patient at
risk of injury
▪ Near microwave machines, magnetic resonance imaging, radiofrequency surgical, or
computer-aided tomography machines
▪ In an explosive atmosphere or in the presence of flammable gas mixtures
▪ If the user has an open wound, rash, infection, swelling, cut, sore, drug patch, or
surgical scar(s) on the neck at the session location
▪ If the user has wet skin, is in the water, or just stepped out of the water (e.g., shower,
bath, pool)

WARNINGS, PRECAUTIONS, POTENTIAL ADVERSE EFFECTS

Warnings indicate instructions, which, if not followed, may result in serious injury or death to
the device user or to the patient.

Precautions indicate instructions, which, if not followed,

may result in damage to the equipment or degradation in the quality of the session.

Warnings:
▪ The safety and efficacy of Pulsetto have not been evaluated in the following users or situations:
▪ Users with uncontrolled hypertension, hypotension, bradycardia, or tachycardia
▪ Users with a history of baseline cardiac disease or atherosclerotic cardiovascular disease,
including congestive heart failure, known severe coronary artery disease, or recent myocardial
infarction (within 5 years)
▪ Users with a history of abnormal baseline ECG, prolonged QT interval, or arrhythmia
▪ Users who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
▪ Pediatric Users
 ▪ Pregnant women
▪ Users with active cancer or cancer in remission
▪ Users with an abnormal cervical anatomy
▪ Users with a history of brain tumor, aneurysm, bleed or head trauma
▪ Users with a history of syncope or seizures

● PRECAUTIONS
Before Use:
▪ You must carefully read the Pulsetto Instructions for Use.
▪ Only use Pulsetto as described in the Instructions for Use.
▪ Do not share Pulsetto with another person.
▪ Pulsetto should not be applied across or through the head, directly on the eyes, covering the
mouth, chest, upper back, or heart.
▪ Remove jewelry that may touch the session location (necklaces, earrings, etc.).
▪ Carefully examine the device for any signs of damage or defects.

Do not use Pulsetto if:

▪ The stimulation surfaces are broken or cracked.
▪ The casing is cracked, dented, or appears to be damaged.

DURING SESSION:
DISCONTINUE SESSION IF YOU EXPERIENCE:
▪ Light-headedness, dizziness, or chest pain
▪ Excessive skin irritation
If the device seems to malfunction, discontinue use immediately. When possible,
contact Customer Service for assistance with your device; Customer Service cannot provide
medical assistance.

CARING FOR YOUR DEVICE:

▪ Turn off Pulsetto when it is not being used. If the device is not turned off, the battery
may become depleted, and the device may not deliver sessions when needed. If the
battery becomes depleted, place it in the charging cable to recharge.
▪ Keep Pulsetto away from water or other liquids, including cleaning liquids.
▪ Moisture may damage the device. Keep Pulsetto away from items such as nebulizers
and steam kettles.
▪ Store Pulsetto in a safe location out of reach of children.
▪ Avoid exposure to extreme hot or cold temperatures outside the range of 0°C to 38°C
(32°F to 100°F). Exposure to such conditions may cause the device to malfunction.
▪ Do not attempt to replace the device battery. If the device is not working, contact
Customer Service.
▪ Do not open or take apart the case or attempt to repair or modify the device. There are
no user- serviceable parts. If the device is not working, contact Customer Service.
▪ Do not intentionally damage, burn, or puncture the device.
▪ Wireless communications equipment, such as wireless home network devices, mobile
phones, cordless telephones, and their base stations, and walkie-talkies, can affect
this equipment. Keep Pulsetto at least 3.3 m (10.8 ft) away from these items while in
use.

Potential Adverse Effects

 Potential adverse effects associated with the use of this device include but are not limited
to the following:
▪ Application site discomfort
▪ Application site irritation/redness
▪ Local pain, face/head/neck area (including toothache)
▪ Muscle twitching and/or contractions, face/head/neck area (including facial droop
and/or lip pull)
▪ Headache/migraine
▪ Dizziness
▪ Tingling, pricking, or a feeling of “pins and needles” on the skin where the device is
applied (paresthesia/dysesthesia)

These side effects typically resolve immediately after the stimulation is complete.
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POTENTIAL RISKS AND COMPLICATIONS ASSOCIATED WITH
OTHER VAGUS NERVE STIMULATION DEVICES
The following risks and complications have been associated with other VNS devices and
may potentially occur with Pulsetto:
▪ Coughing
▪ Gastrointestinal discomfort
▪ Headache
▪ Hoarseness or change in voice
▪ Irregular heartbeat (arrhythmia)
▪ Light-headedness/dizziness
▪ Metallic taste
▪ Muscle twitching and/or contractions of head/neck/face
▪ Nausea
▪ Pain
▪ Shortness of breath (dyspnea)
▪ Skin irritation
▪ Tingling, pricking, or a feeling of “pins and needles” (paresthesia/dysesthesia)

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 Precautions:
▪ Do not submerge the device in water; it is not water-resistant.
▪ Do not use soap, hand sanitizer, detergents, or other cleansers when cleaning the
device.

PRODUCT HANDLING
Operating Conditions – Pulsetto
▪ Range: 10°C to 45°C (50°F to 113°F)
▪ Humidity: 10% to 90%
▪ Barometric Pressure: 80 to 101 kPa
▪ Altitude: Use below 2000 m
▪ Maximum Output: 30V (peak), 40mA (peak)

Storage/Transport Conditions
▪ Pulsetto should be stored at room temperature away from moisture
▪ Range: 0°C to 50°C (32°F to 122°F)
▪ Humidity: 10% to 90%
▪ Barometric Pressure: 80 to 101 kPa

TROUBLESHOOTING
Pulsetto does not turn on
Charge Pulsetto. If the device is charging, the button will glow RED.
Restart Pulsetto. Turn Pulsetto off and on again.
Pulsetto does not charge.
Ensure the USB-C power cord is plugged correctly.
You can find more information in the FAQ section of the application or on the website.

PRODUCT DISPOSAL
Regulations require that the disposal of electrical and electronic equipment,
including used and unused medical devices, is handled in a controlled manner.
A product that may be contaminated after use or contain chemicals or elements
that may present hazards to people or the environment must be disposed of
according to the applicable government regulations. Contact Customer Service
(refer to Section 27) if you have questions about the appropriate disposal of
this device.

NOTE: Pulsetto contains a lithium battery that cannot be removed by the user.

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PRODUCT DESCRIPTION

Pulsetto is a Bluetooth Low Energy communication based device, powered from an internal
rechargeable battery, LiPo 350mAh, 3.7V. The device is powered over a USB-C connector.
The device has a single button to turn-on and turn-off. The main control is done over a
dedicated smartphone application. The device has an internal DC-DC voltage converter that
creates 0.2ms period, 12-46Vp-p, 50%duty cycle impulses 5 impulses that are repeated each
15ms.
Device has a single embedded ceramic antenna with gain of 0.5dBi and the transceiver that
is set to 0dBm Tx. Device operates as a „System using digital modulation techniques“. Single
channel bandwidth is 1MHz, opearating frequency range is 2402-2480MHz.

RETURNS POLICY & WARRANTY

If, for any reason, you are not happy with your purchase, you can return your order within 30
days from the date of delivery for a full refund. Please note that the item price and applicable
taxes will be refunded. Shipping will not be refunded unless an error occurred on our part or
the merchandise is deemed defective.
Returns will not be accepted if any of the following conditions apply:
1. The product is missing parts or has been damaged due to improper use.
2. The product has been damaged or modified from its original form in a manner not
consistent with typical use.
3. The product is not returned with all hardware and accessories.
4. No refunds will be given after thirty (30) days from the date of delivery.
5. All returns must be in their original unaltered packaging.

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NOTICE:
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.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio
exempts de licence. L'exploitation est autorisée aux deux conditions suivantes:
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'appareil doit accepter tout brouillage radioélectrique subi, même si le
brouillage est susceptible d'en compromettre le fonctionnement.

NOTICE:
Changes or modifications made to this equipment not expressly approved by
Pulsetto may void the FCC authorization to operate this equipment.
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ELECTRICAL CLASSIFICATION

❖ Electrical Classification (Pulsetto)

• UL 60601-1 Class III; EN 60601-1 Internally Powered Equipment
• Type BF Applied part
• IP22 Protected against ingress of solid foreign objects ≥ 12.5 mm diameter and protected
against vertically falling water drops when enclosure tilted up to 15°
• Product contains Bluetooth RF transmitter: Frequency range of 2.379 to 2.496 GHz, GFSK
Modulation, 1mW max power

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ELECTROMAGNETIC COMPATIBILITY GUIDANCE

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 particular installation. If
this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.