Ohh-Med Medical Vertica User manual

Vertica® User Manual
Getting Started
Congratulations on your new Vertica® device.
For your safety and the success of treatments, please read and
understand the entire user manual prior to using your Vertica® device.
Keep the manual safe for future reference.
Your attention!
The Vertica® device is designed for personal and intimate
medical treatment at home.
The device left our factory clean and ready for use. The device
will be considered as “used” after removing or damaging the
tamper evident seal on the device.

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Table of contents
Important Note .................................................................................................................................................4
Introduction ........................................................................................................................................................5
About Erectile Dysfunction (ED) ..........................................................................................................6
Treatment with Vertica®................................................................................................................................7
Package Contents ..........................................................................................................................................8
Safety Features Information ...................................................................................................................8
Precaution and safety instructions .....................................................................................................9
Contraindications and warnings ........................................................................................................10
Possible side effects ....................................................................................................................................10
What to Expect After Treatment?..........................................................................................................11
Getting to know Your Vertica® device ..............................................................................................12
Let’s get started! ...........................................................................................................................................20
Recommended treatment .....................................................................................................................22
Recommended care ..................................................................................................................................22
Storage instructions/conditions .........................................................................................................23
Troubleshooting (FAQ) ..............................................................................................................................24
Label Material Specifications ................................................................................................................25
Care, Maintenance and Storage ........................................................................................................27
Disposal of the Vertica® device ...........................................................................................................28
Declaration – electromagnetic emissions ..................................................................................29
Vertica® Warranty ........................................................................................................................................33
Customer Service ........................................................................................................................................36

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Important Note
Before you begin using your Vertica® device, it is important to carefully read all the
necessary information provided in this manual.
Before using your Vertica® device please consult a doctor.
Pay special attention to Instructions, Warnings, Precautions, and Safety.
WARNING: The use of energy emitting devices e.g. laser, intense pulse light,
and radio frequency (RF), must be in accordance with the instructions in the
user guidelines. If used in a manner not intended may cause injury.
This symbol will appear beside possible safety risks.
iThis symbol will appear beside helpful information and tips.

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Introduction
Intended use of Vertica®
Vertica® is a battery powered hand-held medical device that makes use of RF
energy to improve erectile function. The device is intended for home use.
Overview of Vertica®
The Vertica® device is a hand-held medical appliance meant for the purpose of
improving the following:
• Erectile function by increasing blood flow into the penis and cavernosal
volume
• Support increase of tumescence
• Maintain erection and act synergistically for enhancing a better sexual
response
The device has 3sets of electrodes that emit radio frequency (RF) energy that
increases the temperature inside the penis, enhancing penile erectile response.

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About Erectile Dysfunction (ED)
Erection is a neuro-vascular event. Excited nerves initiate erection by dilating
the arteries (used for increasing blood flow into the penis), when the nervous
and vascular systems are intact- erection occurs. Any neural or vascular (blood
vessels) dysfunction may have a negative impact on normal erectile function.
Powered by patented technology, Vertica® is a non-invasive home-use device for
the treatment of ED by enhancing blood inflow into the erectile bodies, thereby
improving the erection process.
The Vertica® device is the first appliance that targets the blood vessels involved in
erectile function, by inducing thermal stimulation which causes even more blood
inflow allowing dilatation of the arteries.
The Vertica® technology generates vasodilation using its RF energy induced heat in
the areas involved in the erectile process.

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Treatment with Vertica®:
• The Vertica® device consists of two parts that accurately provide a deep
treatment for erectile dysfunction.
• The erectile tissue which is responsible for erection expands (or stretches) from
the visible part of the penis, deep into the pelvis and behind the pubis.
• The PAD part of the Vertica® device is designed to treat this area specifically.
• Therefore, the Vertica® method has a high-degree of accuracy - it covers
the whole length of the erectile bodies and provides a complete therapeutic
solution to the issue.
• The Vertica® device consists of 6 (RF) generator electrodes (and one pair of
pins) located around the inner circle of the device’s ring. The combination of
the advanced algorithm controls equal delivery spreads of RF energy, with
simultaneous real-time regulation of the optimal energy outflow by continuous
skin temperature measurement. This process ensures that the user experiences
optimal individual results.
• Each treatment is unique due to the use of particular hardware and software
technology. The required optimal level of energy on the specific area of
treatment is provided during actual real-time use.
• The target tissue is accessed by the RF energy which is channeled by the
novel positioning mode of the electrodes, resulting in optimal treatment to the
selected area.
• During treatment sessions, the device gathers data, learns and retains
calculated skin parameters and adapts the device’s parameters accordingly.
• Applying ultrasound gel or RF conductive gel during treatment ensures the
best-possible energy transmission between the electrodes and the target area.

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Package Contents
Your Vertica® package contains the following items:
• Vertica® device
• Electrode PAD
• Charger/Adapter
• Ultrasound or RF conductive gel*
• Quick reference guide
• User manual
• Device warranty
* Vertica® provides ultrasonic/conductive RF generic gel with CE certication.
Safety Features Information
With Vertica®, your safety comes first!
Please read the information provided before use.
The Vertica® device is created with the following safety features:
• Six Temperature sensors - the skin surface temperature is continuously
monitored and measured by six specifically designed sensors concealed
inside the electrodes.
• Ultrasound gel or RF Conductive gel - The device will automatically stop
delivering energy once it identifies lack of skin contact between the Vertica®
electrodes, RF conductive gel, and the skin surface of the penis.
• Power LEDs (1-6) - Six LEDs are located around the energy button. Each
LED indicates a power level that lights-up according to the selected power
strength that flash during treatment. Whenever RF is not delivered, the LEDs
will stay lit without flashing. The number of LEDs always indicates the power
level. One LED is the minimum level; six LEDs is the maximum power level. The
device is equipped with an automatic control mechanism to prevent over-
heating; the “smart” sensor on the device detects optimal temperature,
allowing full regulation of energy transmission.

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• Charging - All functionality will stop once the charging cable is connected
to the device.
• Penile shaft sensor - The device will automatically deliver RF energy only when
the required penile shaft characteristics (impedance values) are correctly
measured by the device. Energy is delivered when these measured values
match with the device’s pre-determined values to allow optimal treatment.
• Automatic power off - The device will automatically shut down after 10
minutes of inactivity.
Precaution and safety instructions
Only use this device for its intended function and as instructed in the user manual.
• Always switch the device off after each treatment session and during
cleaning.
• The device must be charged only with the supplied charger. Do not use any
other charger!
• Do not use the device if it is damaged.
• Do not operate the device close to any inflammable liquids (i.e. alcohol and
acetone).
• Always keep the device out of reach of children.
• Do not attempt to use the device on any other parts of the body other than
that permitted in the instructions.
The device requires the use of either RF conductive gel or ultrasound gel. For
your safety and in order to achieve effective treatment, a generous layer of gel
should be applied along the penis and care should be taken to add gel as needed
during the treatment. For illustration, please see Figure 5. Prior to use, check the
validity and expiry dates on the label of the RF conductive gel.
Once opened, do not use the gel after the 12-month period. If the gel is purchased
separately, please ensure that the product meets the regulatory requirements of
the local Ministry of Health, and that it is intended for ultrasound or RF conduction
purposes.

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Contraindications and warnings
Do not use the Vertica® device if you experience any of the following
conditions:
• A cardiac pacemaker implant or suffer from any other form of heart condition
e.g. Arrhythmia
• Any metallic implanted devices, including body piercings located around the
area of treatment.
• Any type of skin damage to the area of intended treatment e.g. lesions
• A blood clot disorder
• Diabetes or autoimmune disease
• Take antiplatelet medication
• Take or have taken in the last 12 months Isotretinoin (Accutane)
• Any Neurostimulator implant
Please consult your physician if you have any concerns
regarding medications or health conditions not listed above.
Possible side effects
Due to the treatment which is heat-based, redness of the skin and minor swelling
may occur. * This is an indication that the proper required heat is applied for the
desired outcome to be achieved. However, after treatment the redness of the skin
and minor swelling will subside.
Additional side effects may occur such as mild local pain, blistering, stinging,
burning, and flaking. These effects can last for several minutes and are expected
to ease over time with subsequent treatments. Discontinue the treatment if any
of the above-mentioned side effects continue for over 24 hours (Please consult
your physician).
Take note that treatment results differ between users due to individual uniqueness
which is not manufacturer guaranteed.
If you have any concerns regarding the sensitivity conditions or side effects, please
consult your physician.
*Energy output will automatically stop once the “smart” sensors detect lack of gel
or lack of contact with the penis.

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What to Expect After Treatment?
Short-term Effect
After a session, an overall warm sensation is felt on the treated area. This effect
subsequently dissipates.
Long-term Effect
For the desired effective result, twice-weekly treatments are recommended.

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Getting to know Your Vertica® device:
Panel interface
Fig 1: Led indicators and control buttons
Indicators Control buttons
1 - Energy is delivered, skin parameters are in correct
range (Indicated by constant white LED) 6 - Decrease energy
level
2- Enabling device to power energy out
(flashing blue LED)
7 - Increase energy
level
3- Charging (Orange LED) 8 - Energy button
4 - Power supply connected (Green LED)
10 - Power and Mode
button
5- Mode indicator
9 - Power Level indication
RING
RING+PAD

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Control buttons and indicators
All control buttons and indicators are situated on the right-side handle.
See fig 1. There are 2 round buttons, and 2 half-round buttons:
1. The Power switch and indicator
The round button on the left is the power switch:
Press the power button to turn the device “ON”. Power “ON” is indicated by lightering
the selected mode (“Ring” or “Ring + Pad”).
The power switch is also used to select between “Ring mode and “Ring + Pad”
mode:
“Ring” means that only the ring electrodes are “on” (those surrounding the penis)
and the pad is “OFF”.
“Ring + Pad” means that, the ring and pad electrodes are both “on”.
How to select “Ring mode”: The device will start by default at “Ring mode”. Each
press on the power button will alternate between the two modes, ‘’Ring” mode and
‘’Ring + Pad” mode.
To turn OFF the device, press and hold the power button for 3seconds.
2. Energy button & Power level indication
This button is the round button on the right:
Press and hold the Energy button to enable energy output; The LEDs will steadily
remain lit when the device is “On” and the energy button it is not pressed.
Important: It is possible to lock this function by a double click. This feature is enabled
only after 3 seconds of single pressing. (Indicated by Constant Blue LED). Press any
button on the device to cancel lock.
The power level LED lights indicate the power level output. The LEDs will flash when
the energy button is pressed. Ranges from 1-6 (low to high).
1. The first minimum power level is indicated by a single white LED light.
2. The second power level is indicated by two white LED lights.
3. The third power level is indicated by three white LED lights.

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4. The fourth power level is indicated by four white LED lights.
5. The fifth power level is indicated by five white LED lights.
6. The sixth power level is the maximum and is indicated by-six white LED
lights.
3. Plus and Minus buttons (+/-)
They are half-round buttons located between the 2 rounded buttons (power switch
and energy buttons):
Press the plus (+) button to increase the energy output. The power level
will increase, as indicated by the LED light circling the energy button on the
right. Press the minus (-) button to decrease the energy level indicated by
one less LED light circling the energy button on the right.
4. Charging LED indicator
During charging, the Orange indicator will turn on. When the device is fully
charged, the indicator will turn OFF. If the indicator flashes, this means
that there is a fault with the Battery or charger. If this happens, please
disconnect the charger from the power outlet and the device.
Wait for a minute before re-connecting to the charger and power outlet. If
the Orange light continues to flash contact customer support.
The device will not permit treatment when the battery needs to be charged. In this
case, the device will not operate.
The magnetic charger must be attached to the charging connector situated on
the left side of the control panel handle (See fig.2). Only then connect the cable to
the electrical outlet

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Fig 2
1. Power supply connector
2. Release handle
3. Electrodes
4. Pad connector
5. User interface
5. Energy output electrodes
All electrodes must be in full contact with the skin area during treatment. Press the
energy button to allow energy release. The LED flashing lights indicate energy
output is active from the electrode tips.
6. Applying the PAD
It is recommended to shave the perineal area before applying the PAD (the
area between the anus and scrotum). We recommend applying the PAD before
inserting the penis into the ring.

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Step 1: Connect the pad extension to the device at the designated connector (fig 3).
Step 2: Place the electrode of the pad (fig 3a) to your skin at the perineum area
(fig 3b) always maintain contact between the electrodes and your skin.
The PAD will activate only when the “Ring & Pad” mode is on.
Fig 3
Fig 3a
Pad-electrodes

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Fig 3b
6. Penis insertion side
Open the ring with the “release” handle and insert penis, (fig 4). Insert the penis
from the back end through to the front end of the device, as indicated in fig 4a.
Fig 4
PAD

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Fig 4a
7. RF energy
The white indicator ( ) means energy delivery is “ON”. The light will switch “ON”
most of the time. When the heat exceeds the preset temperature threshold, it
turns off indicating the energy delivery has stopped until it returns to the pre-set
temperature limits.
Both “Ring” and “Ring & Pad” modes should work for a total of 15 minutes for each
mode. After preforming the process of 15 minutes of Energy delivery (indicated by
White LED), the device will indicate that the session has ended with 3 consecutive
vibrations. Total time of treatment will depend on individual skin characteristics.

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Indicator summary
State Indication light Activity Indication
Device ON Power switch
indicator
The Vertica® device is
on and ready
RF active ON White light ON Skin parameter at
correct range
Energy active Flashing blue
Led
RF energy
active
Charger
connected
External power
indicator ON Vertica® connected to
external power
Charging Charging
indicator ON Device is connected
and actively charging
Battery fully
charged
Charging
indicator OFF
External power
indicator ON
Battery is fully charged
and still connected to
power supply
Energy level
Connected
to the
selected mode
Six Leds around
trigger button
One LED light
indicates power level 1
(minimum)
Two LED lights indicate
power level 2
Three LED lights
indicate power level 3
Four LED lights indicate
power level 4
Five LED lights indicate
power level 5
Six LED lights indicate
power level 6
(maximum)

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Let’s get started!
Treatment procedure:
Start treatment in a seated position making sure the electrodes of the pad are in
contact with the perineum area. In the first stage the treatment is only “Ring mode,
and in the second stage you move to the “Ring+Pad” mode.
It is recommended to shave the perineum area to ensure optimal contact.
Check that the device is fully charged before treatment. The battery LED indicator
on the right means that the device is ready for use.
1. Press the power button to switch the device on. By default, the device
is now in standby mode - both energy level and power indicator show
that the device is “ON” at the minimum power level and in “Ring” mode.
2. Stay on “Ring” mode (default) or switch to “Ring + Pad” mode by pressing
the power button.
3. To Select the desired level of power, press the plus or minus (“+”
or “-”) button to increase or decrease the energy output level. It is
recommended that you start the first treatment at level 1 and increase
according to the sensation of heat you desire. You are able to increase
or decrease the energy level during the treatment. Choose the maximum
heating level that you feel comfortable with during treatment.
4. Apply ultrasound/RF conductive gel along the penis to fully cover the
surface. In order to achieve optimal treatment, a generous layer of gel
should be applied. Make sure that the gel layer covers about 3-5 mm of
the electrode dome as shown in the Figure 5. Add gel as needed during
treatment.
Fig 5