mibeTec HERPOtherm User manual

Intended use
HERPOtherm®is a patented medical device for the local treatment of symptoms that accom-
pany cold sores (herpes simplex labialis) such as itching, burning, ngling or ghtness.
HERPOtherm®can normally prevent the development of cold sore blisters if applied early
enough. If applied later, the severity of symptoms may be lessened, or they may fade sooner.
The rst signs of an outbreak (so-called prodromal symptoms) are generally itching, burning,
ngling or ghtness.
How it works
HERPOtherm® works solely by concentrated heat and is thus completely free from chemicals.
Hence, HERPOtherm® is also suitable for pregnant women, allergy suerers and children.
The applicaon of concentrated heat (local hyperthermia) is a physical mode of acon based
on a brief, concentrated applicaon of heat to a small, limited area of skin. Even a localised
pulse of heat may be sucient to relieve symptoms such as itching, burning, ngling or ght-
ness and, if applied early enough to normally prevent the formaon of cold sore blisters.
Administraon
HERPOtherm®is very simple to use:
– Remove the protecve cap from the device. Place the ceramic contact plate of the device
onto the aected skin area and gently press it against the skin.
– Press the buon and the ceramic contact plate will heat up to a temperature of around
51°C. Once this temperature is reached, a LED will light up. The LED will go o once the
device automacally shuts down aer 3 seconds of use. At the start of the heang-up
phase and at the end of treatment, you will hear an addional acousc signal.
– Place the protecve cap on the device.
For persistent or recurrent symptoms, mulple treatment of the same skin site is possible.
Please leave a treatment interval of at least 2 minutes between each applicaon. Do not ex-
ceed a maximum number of 5 applicaons per hour on the same skin area.
Direcons for use
HERPOtherm® is indicated only for self-administraon by adults and children aged 12 years
and older. In children under 12 years of age, it should be used only with the assistance of an
adult.
To prevent virus transmission and for reasons of hygiene, HERPOtherm®should only ever be
used by one person.
Cold sores are a viral disease caused by the herpes simplex virus. It is transmied by droplet
infecon, by direct contact or as a smear infecon.
There is no permanent cure for infecon with the herpes simplex virus.
Cleaning informaon:
The ceramic contact plate of the device can be easily cleaned with a standard alcohol disin-
fectant wipe; all other external surfaces, for example, with a clean cloth.
Baery replacement:
To change the baery, the protecve cap and baery cap must be removed and reed aer
inserng the baery (see illustraon).
When the baery needs changing, the LED will ash 3 mes and the acousc signal will
sound 3 mes.
Do not use rechargeable baeries.
Warnings
HERPOtherm®must not be used in or on
– eyes and eyelids
– mucous membranes
– open wounds, damaged skin (e.g. open blisters)
– scalded or burnt skin
– frostbite
– small-bre neuropathy, allodynia, hyperalgesia
– tumours and malignant changes of the skin
– people with reduced sensivity due to physical or medical complaints
– sensive skin areas or skin areas with poor blood supply.
Medical advice should be sought in the following cases:
– persistent symptoms while using HERPOtherm®.
– worsening symptoms while using HERPOtherm®. Unl these have been claried, you
should stop using the device.
Furthermore, the device must not be used:
– immediately aer applicaon of ointments, creams, loons etc. on the aected site.
– on moist skin.
Depending on sensivity, the treatment temperature may cause some discomfort.
In sensive individuals, a temporary reddening of the skin may occur aer use. In rare cases,
users with sensive skin types may experience skin irritaon.
The device indicates failure by ashing the LED 5 mes and sounding the acousc signal
5 mes. This may occur if used incorrectly, e.g. if the user triggers and operates the device
in the air instead of on the skin. If this error message occurs repeatedly despite proper use,
please contact the manufacturer or distributor.
Do not use the device if damaged or in case of obvious malfuncon. Do not use damp or
damaged baeries. Protect the device from moisture.
Storage instrucons
Store the device protected from direct sunlight and in a dry place.
Do not use the baery beyond the expiry date which is stated on the baery. In order to avoid
damage to HERPOtherm® due to leaking baery acid, the baery should be taken out during
prolonged periods of non-use (inacvity).
Simple quick well-tolerated
A medical device for the symptomac treatment of cold sores
UNSCREW
1
PULL OFF
2
INSERT BATTERY (CR2 3V)
3
Instrucons for use
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Manufacturer:
GmbH
Münchener Strasse 15
06796 Brehna
Germany
Tel.: [phone]
Fax: [phone]
Distributor:
Mibe Pharma UK Ltd
Marco Polo House
3-5 Lansdowne Road,
Croydon,
United Kingdom, CR0 2BX
Tel.: [phone]
E-mail: [email protected]
www.herpotherm.eu
Please contact the manufacturer or distributor if you have any quesons about the device or
how it works.
Date of revision of the text: December 2018
Please read the instrucons for use. Protect the device from direct sunlight and
store in a dry place/protect from moisture.
See device for batch number Do not dispose with household waste
Technical data:
CR2 3V Applied part Type BF
Baery type/-voltage according to EN 60601-1
0123
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