Full Product Manual

Trouble shoong
bite away
®
is not heang up – try an applicaon on another spot and try to feel the heat
– replace baery and try again
bite away
®
without funcon – replace baery and try again
bite away
®
baery empty – replace baery
bite away
®
LED ashes 3 mes and device
beeps simultaneously
– replace baery
bite away
®
LED ashes 5 mes and device
beeps simultaneously
– replace baery and try again
– if the error occurs again contact distributor or manufacturer
Disposal of bite away
®
or baeries
Please do not use the bite away
®
in case of malfuncon, visual defects or in reach of the shelf life.
The shelf life of the bite away
®
is dened up to 5 years. The shelf life of the baeries is indicated on the baeries.
Please dispose the bite away
®
without baeries concerning the naonal regulaons for electronic disposals. Baeries must be
disposed separately as hazardous waste.
Complaint & Service
In case of complaint or service please contact the distributor or the manufacturer.
Manufacturer Distributor
GmbH U.S.
Münchener Straße 15 801 Barton Springs Rd.
06796 Brehna Ausn, TX 78704
Germany USA
e-mail: [e-mail]
Informaon on Electromagnec and Other Interferences
The bite away
®
has been evaluated and deemed compliant with the requirements in EN60601-1-2 Class B for Electromagnec
Compability (EMC). Medical Electrical Equipment needs special precauons regarding EMC and needs to be installed and put
into service according to the EMC informaon provided in this User Manual.
Portable and mobile RF communicaons equipment can aect Medical Electrical Equipment. The bite away
®
should not be
used adjacent to or stacked with other electromagnec equipment. If adjacent or stacked use with other electromagnec
equipment is necessary, verify that the bite away
®
operaon is normal in the conguraon(s) in which it will be used.
The medical equipment bite away
®
needs special precauons regarding EMC and needs to be installed and put into service
according to the EMC informaon provided in this secon of the manual.
Portable and mobile RF communicaons equipment can aect the medical equipment bite away
®
.
The bite away
®
may be interfered with by other equipment, even if that equipment complies emission requirements.
Guidance and manufacturer’s declaraon – electromagnec emissions
The bite away
®
is intended for use in the electromagnec environment specied below. The customer or the user of the bite
away
®
should ensure that it is used in such an environment.
Emissions test Compliance Electromagnec environment – guidance
RF emissions
CISPR 11
Group 1
The bite away
®
uses RF energy only for its internal funcon. Therefore,
its RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11
Class B The bite away
®
is suitable for use in all establishments, including do-
mesc establishments and those directly connected to the public low
voltage power supply network that supplies buildings used for domesc
purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage uctuaons/
icker emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaraon – electromagnec immunity
The bite away
®
is intended for use in the electromagnec environment specied below. The customer or the user of the bite
away
®
should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnec environment –
guidance
Electrostac discharge (ESD)
IEC 61000-4-2
+/- 6kV contact
+/- 8kV air
+/- 6kV contact
+/- 8kV air
Floors should be wood, con-
crete or ceramic le. If oors
are covered with synthec
material, the relave humidity
should be at least 30%.
Electrical fast transient / burst
IEC 61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for input/output
Not applicable
Surge IEC 61000-4-5 +/- 1 kV line(s) to line(s)
+/- 2 kV line(s) to earth
Not applicable
Voltage dips, short interrup-
ons and voltage variaons on
power supply input lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT)
for 0.5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 s
Not applicable
Power frequency
(50/60 Hz) magnec eld
IEC 61000-4-8
3A/m 3A/m Power frequency magnec
elds should be at levels cha-
racterisc of a typical locaon
in a typical commercial or hos-
pital environment.
NOTE UT is the a.c. mains voltage prior to applicaon of the test level.
Guidance and manufacturer’s declaraon – electromagnec immunity
The bite away
®
is intended for use in the electromagnec environment specied below. The customer or the user of the bite
away
®
should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnec environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
Not Applicable
3 V/m
Portable and mobile RF communicaons equip-
ment should be used no closer to any part of
the bite away
®
, including cables, than the re-
commended separaon distance calculated from
the equaon applicable to the frequency of the
transmier.
Recommended separaon distance
Not Applicable
d = 1.17 √P 80 MHz to 800 MHz
d = 2.33 √P 800 MHz to 2.5 GHz
where P is the maximum output power rang
of the transmier in was (W) according to the
transmier manufacturer and d is the recommen-
ded separaon distance in meters (m).
Field strengths from xed RF transmiers, as
determined by an electromagnec site survey,
a
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and reec-
on from structures, objects and people.
a
Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theorecally with accuracy. To assess the electromagnec environment
due to xed RF transmiers, an electromagnec site survey should be considered. If the measured eld strength in the locaon in which
the bite away
®
is used exceeds the applicable RF compliance level above, the bite away
®
should be observed to verify normal operaon.
If abnormal performance is observed, addional measures may be necessary, such as re-orienng or relocang the bite away
®
.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separaon distances between portable and mobile
RF communicaons equipment and the bite away
®
The bite away
®
is intended for use in an electromagnec environment in which radiated RF disturbances are controlled. The
customer or the user of the bite away
®
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
®
as recommended below,
according to the maximum output power of the communicaons equipment.
Rated maximum output
power of transmier
W
Separaon distance according to frequency of transmier
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
0.01 Not applicable 0.1 0.23
0.1 Not applicable 0.4 0.74
1 Not applicable 1.2 2.3
10
Not applicable 3.7 7.4
100 Not applicable 12 23
For transmiers rated at a maximum output power not listed above, the recommended separaon distance d in meters (m)
can be esmated using the equaon applicable to the frequency of the transmier, where P is the maximum output power
rang of the transmier in was (W) according to the transmier manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separaon distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and reec-
on from structures, objects and people.
GI03322-01
GI03322-01_bite_away_US.indd 2 03.05.2019 11:16:17