Full Product Manual

Product Descripon
The bite away
®
is a patented handheld device that allows the user to apply a therapeuc dose of heat directly to an insect sng
or bite and is clinically proven to provide temporary relief of the resulng itching, pain and swelling. If the device is applied
immediately aer the sng or bite, the symptoms can usually be prevented completely. Even if the device is used slightly later,
the symptoms can sll subside sooner.
bite away
®
works solely by concentrated heat and is thus completely free from chemicals (also suitable for pregnant women,
allergy suerers and children).
The bite away
®
allows the user to choose either a 3 second heat dose or a longer 5 second heat dose. The ceramic contact
surface is heated up to 122 - 127°F (50 - 53°C) by an integrated micro-processor and maintained for 3 or 5 seconds according
to the buon selected.
The bite away
®
is provided with two AA LR6 1.5V baeries to power the device, which have to be placed into the baery
compartment before the rst use (see illustraon below).
Indicaons for Use
The bite away
®
is indicated for use to provide temporary relief of the itching and pain resulng from insect sngs and bites such
as bees, wasps and mosquitoes by temporarily increasing localized blood ow.
User group/paent group:
adults and children aged 12 years and older in self-applicaon / under 12 years only in third party applicaon by adult person
Environment:
all environments except oxygen rich environment
Contraindicaons
– Not for use on mucus membranes (e.g. inside of the mouth, nose, etc.).
– Not for use on or near the eyes. Do not simultaneously use with medicaon and/or cosmecs.
– Not for use in case of heavy or chronic skin inammaon or severe internal diseases, in which the use could cause deterio-
raon, such as:
• open wounds, damaged skin
• scalded or burnt skin
• frostbite
• small-ber neuropathy, allodynia, hyperalgesia
• tumors and malignant changes of the skin
• people with reduced sensivity due to physical or medical complaints.
Direcons of Use
– Remove the snger before applying the bite away
®
to the site of the sng.
– Place the contact surface (round ceramic disc at the p of the device) directly onto the skin where the bite or sng had
occurred and gently press it against the skin.
– Choose either:
3 second treatment me (le buon) for the inial treatment and sensive skin (e.g. paents under 12 years of age in
third party applicaon) or
5 second treatment me (right buon) for regular applicaon.
– Press the buon and release immediately. The ceramic contact surface is heated up to a temperature of around 124°F
(51°C). Once this temperature is reached, the LED will light up. The LED will go o once the device automacally shuts
down aer the end of the chosen treatment me. At the start of the heang-up phase and at the end of the treatment, you
will hear an addional acousc signal.
– For successful treatment, do not interrupt the indicated duraon of the treatment. The treatment of the same insect sng
or bite may be repeated as required. Please leave a treatment interval of at least 2 minutes between each applicaon. Do
not exceed a maximum number of 5 applicaons per hour on the same insect sng or bite.
– The device packaging includes two baeries (2x AA LR6 1.5V). Empty baeries of the bite away
®
are indicated when LED
ashes 3 mes and triple acousc signal is heard.
!
Warnings
– Use carefully - may cause serious burns. Do not use over sensive skin areas or in the presence of poor circulaon. The
unaended use of the bite away
®
by children or incapacitated persons may be dangerous.
– To avoid contaminaon to other person, the bite away
®
is intended to be used by only one person.
Do not apply one bite away
®
to more than one person.
– The heated ceramic surface may reach a maximum temperature of 127°F (53°C).
– If you may use the device repeatedly on the same sng or bite, insure a pause of at least 2 minutes before repeated applica-
on. Do not exceed a maximum number of 5 applicaons per hour on the same insect sng or bite.
– The bite away
®
is not intended to replace medical advice or treatment. If symptoms (e.g. pain) are severe or persistent,
consult a physician.
In the event of severe hypersensivity reacons aer an insect sng or bite (anaphylacc reacon), bite away
®
is not a re-
placement for emergency treatment. You should immediately call a doctor at the rst signs of any such reacon (e.g. increased
itching, reddening, swelling or formaon of a welt, dizziness, nausea, dicules breathing, hypotension or hypertension).
Medical advice should be sought in the following cases:
• persistent symptoms while using bite away
®
.
• worsening symptoms while using bite away
®
. Unl these symptoms have been claried, you should stop using the device.
– Do not use on or near the eye area or on mucus membranes (e.g. inside the mouth or nose).
– Individuals with impaired sensivies due to physical or medical condions should use extreme cauon when using the bite
away
®
. If in queson, consult a physician prior to use.
– Do not use the bite away
®
if damaged or in case of obvious malfuncon. Do not use damaged baeries.
– For external use only.
– The use of other accessories as listed in this IFU may negavely aect the EMC performance or lead to noncompliance.
– If you intend to not use the bite away
®
for a longer me, please remove the baeries to prevent them to leak out.
– The bite away
®
is not intended to be used in oxygen rich environment.
– Please keep away the bite away
®
from young children or babies, because small parts (like a disassembled baery cap) could
be swallowed.
– Electromagnec interference (EMI) from common household products such as security systems, metal detectors, diathermy
equipment, MRI devices, RFID (Radio Frequency Idencaon) eming devices may interfere with the bite away
®
device.
The bite away
®
should not be used adjacent to or stacked with other electromagnec equipment. If the bite away
®
device
is adjacent or stacked with other electromagnec equipment , assure that the bite away
®
operaon is normal by verifying
that the LED light illuminates and the device emits a ‘beep’ when the le and or right buon is pressed prior to contacng
the device with the skin. You can help prevent electromagnec interference by maintaining a minimum distance between
portable and mobile RF communicaons equipment (transmiers) and the bite away
®
.
– Contact with liquids: Do not soak in water, wash or lubricate the bite away
®
, this may damage it. Do not use water, chemicals
or other cleaning soluons to clean the bite away
®
. Furthermore, the device must not be used on moist skin.
!
Precauons
– Not recommended for children under the age of 2 years.
– The bite away
®
is indicated only for self-administraon by adults and children aged 12 years and older. Children under the
age of 12 years should only use the device under the supervision of an adult.
– The bite away
®
is intended for the relief of itching and pain immediately aer an insect sng or bite. In case of an allergy to
these insects (or in the case of connuous pain), consult a physician immediately.
– The bite away
®
is not eecve against venom from spiders, scorpions or snakes.
– The use of bite away
®
may cause reddening of the skin.
– The use of bite away
®
may cause a burn blister if used on the same skin area more than once within a short period of me.
– The use of bite away
®
may cause a snging sensaon or a transient hot feeling.
Maintenance
A periodic maintenance is not dened. Please clean the bite away
®
or replace the baeries if necessary.
Cleaning and Storage
– Please clean the outside of bite away
®
by wiping it with a clean cloth.
– Do not soak in water, wash or lubricate the bite away
®
, this may damage it.
– Do not use water, chemicals or other cleaning soluons to clean the bite away
®
.
– Clean o dirt and dust with a dry cloth.
– Please store the bite away
®
on a safe place, dry, clean, no extreme heat and without direct sunlight.
– Please do not drop the bite away
®
on hard surface.
Warranty
2 years (valid from date of purchase)
Technical data
Heang mes
inial treatment and
persons with sensive skin
child (12 – 18 years of age)* or
child (under 12 years of age)** or
adult (over 18 years of age)*
regular applicaon
child (12 – 18 years of age)* or
child (under 12 years of age)** or
adult (over 18 years of age)*
3s
5s
Range of ceramic p temperature
target treatment temperature
122°F (50°C) – 127°F (53°C)
124°F (51°C)
Internal voltage 2.4 + 3.0 V (2x AA LR6 1.5V baeries)
shelf life of baery: please refer to baery labeling
! Only original baeries containing labeling for shelf life are allowed for use with
the bite away
®
!
* self-applicaon
** only in third party applicaon by adult
Accessories
– 2x AA LR6 1.5V baeries (no rechargeable baeries allowed)
The use of other accessories as listed in this IFU may negavely aect the EMC performance or lead to noncompliance!
Removal or Replacement of Baeries
2x AA LR6 1.5V baeries included in delivery. Before the rst use, place the baeries
into the baery compartment as shown in the illustraon.
Please remove the baeries when you intend to not use the bite away
®
for a longer me,
to prevent the baeries to leak out.
A storage of the baeries at cool temperatures (<30°C) will obtain their lifeme.
If the bite away
®
indicates empty baeries, please replace them.
Environmental Condions
The bite away
®
is intended for storage and operaon in a room-temperature environment.
Condion Temperature Humidity
Pressure
(Altude)
Operang 08°C – 40°C 15% – 93% 700 hPa – 1060 hPa
Storage 08°C – 40°C* 15% – 93% 700 hPa – 1060 hPa
Transport 08°C – 40°C 15% – 93% 700 hPa – 1060 hPa
* in case of longer storage without baeries (please remove the baeries and store them cool < 30°C)
Symbols
Refer to manual
!
Cauon:
Consult instrucons for use
Type BF Applied Part CLASS II equipment
Batch Code
or
Manufacturer
12
6
3
9
1
2
4
5
7
8
10
11
Charge clock Protect against UV rays
Operang temperature
Storage temperature
or
Protect against liquids
Keep away from rain
IP42
Protecon against Ingress
of Solids and Liquids
Disposal of waste products
%
Humidity condions
MR
MRI Unsafe – Keep away
from magnec resonance
imaging (MRI) equipment
Instrucons for Use
PRESS
1
OPEN
2
INSERT BATTERIES
3
86 °F
47 °F
GI03322-01_bite_away_US.indd 1 03.05.2019 11:16:17