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.