dance and M
Manufacturerr’s Declaratio
on Electrom agnetic Emissions & Imm
munity
Guid
Phon
nak SPICE, S
SPICE+ and QUEST
Q
Heariing Aids
nt (e.g.
With the increased number of elecctronic devices such as PC’s aand other portaable and mobile radio frequenncy communicaation equipmen
mobile phones), meddical devices in use may be susceptible to eleectromagnetic interference fro
om other devicees. The use of accessories and cables
han Phonak orig
ginal parts) mayy result in increeased emissionss or decreased im
otherr than those speecified (other th
mmunity of thee unit.
The EMC
E
(Electro M
Magnetic Compaatibility) standaard IEC60601-1 -2 defines the levels of immu
unity to these eelectromagneticc interferences.. From
the other
o
hand, meddical devices must
m
not interfeere with other devices. IEC606
601-1-2 also defines the maxximum levels off emissions for these
mediccal devices. Phoonak wireless Hearing Aids con
nform to this IE C60601-1-2 standard for imm
munity and emisssion.
Nevertheless, mediccal equipment needs
n
special precautions
p
reggarding EMC an
nd needs to be installed and put into servicce according too EMC
mation providedd in this docum
ment. This declaration currentlyy applies for wireless Phonak SPICE,
S
SPICE+ a nd QUEST Hearring Aids collecttions.
inform
Table 1: Guidancee and manufactturer’s declarattion – electrom
magnetic emissions
The Phonak wirelesss Hearing Aids are intended for
f use in the e lectromagnetic environment specified below. The customer or
o the user of the
Pho
onak wireless Heearing Aids should assure that it is used in suuch an environm
ment.
Emiissions test
Compliance
RF emissions
e
Group 2
Th
he wireless Hea
aring Aids musst emit electromagnetic energgy in
order to perform its intendded function. Nearby electrronic
eq
quipment may be
b affected.
Class B
Th
he wireless Hearing
H
Aids are suitable for use in all
esstablishments other
o
than dom estic and thosee directly conneected
to
o the public lo
ow-voltage pow
wer supply nettwork that suppplies
buildings used fo
or domestic purrposes.
CISP
PR 11
RF emissions
e
CISP
PR 11
Electromagneticc environment – guidance
Harmonic emissionns
IEC 61000-3-2
Not applicable
Volttage fluctuationns/ flicker
emissions IEC 610000-3-3
Not applicable
Table 2: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The Phonak wirelesss Hearing Aids are intended for
f use in the e lectromagnetic environment specified below. The customer or
o the user of the
Pho
onak wireless Heearing Aids should assure that it is used in suuch an environm
ment.
Electrom
magnetic environment –
guidancce
Imm
munity test
IEC 60601 testt level
Compliance levvel
Elecctrostatic dischaarge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contactt
± 8 kV air
Elecctrical fast transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
Not applicab
ble
Not appplicable
Surg
ge
IEC 61000-4-5
± 1 kV line(s) to
o line(s)
± 2 kV line(s) to
o earth
Not applicab
ble
Not appplicable
Volttage dips, shortt
inteerruptions and vvoltage
variations on poweer supply
ut lines IEC 610000-4-11
inpu
<5 % UT (>95 % dip in UT) forr 0,5 cycle
Not applicab
ble
Not appplicable
Pow
wer frequency (550/60 Hz)
mag
gnetic field
IEC 61000-4-8
3 A/m
Floors should be wood,
w
concretee or
ceramicc tile. If floorss are covered with
synthetiic material, the relative hum
midity
should bbe at least 30 %.
%
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 225 cycles
<5 % UT (>95 % dip in UT) forr 5 s
3 A/m
Power ffrequency magnetic fields sh
hould
be at llevels characteeristic of a typical
locationn in a typical commercial or
hospitall environment.
NOTTE UT is the a.c. mains voltage prior to application of
o the test level.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 1/11
Table 4: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The Phonak wirelesss Hearing Aids are intended for
f use in the e lectromagnetic environment specified below. The customer or
o the user of the
Pho
onak wireless Heearing Aids should assure that it is used in suuch an environm
ment.
Immunity test
IEC 6060
01 test level
Compliance level
Electro
omagnetic enviironment – guidance
Portable and mobile
e RF communiccations equipment should be used
oser to any parrt of the Phonaak wireless Hearing Aids, inclu
uding
no clo
cables, than the reccommended sepparation distan
nce calculated from
the eq
quation applicable to the frequuency of the traansmitter.
Recom
mmended separration distancee
Con
nducted
RF IEC 61000-4-6
3 Vrms
150 kHz too 80 MHz
Not applicaable
Radiated
RF IEC 61000-4-3
3 V/m
80 MHz too 2,5 GHz
3 V/m
d = 1,2 P
d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 800 MHzz to 2,5 GHz
wheree P is the maxiimum output ppower rating off the transmitter in
wattss (W) according
g to the transm
mitter manufaccturer and d iss the
recom
mmended separa
ation distance iin metres (m).
Field strengths from
m fixed RF traansmitters, as determined byy an
e survey, a shoould be less th
han the compliance
electrromagnetic site
level in each frequen
ncy range. b
h the
Interfference may occcur in the vicinnity of equipment marked with
follow
wing symbol:
NOTTE 1 At 80 MHz annd 800 MHz, the higher frequencyy range applies.
NOTTE 2 These guidellines may not appply in all situations. Electromagnnetic propagation
n is affected by absorption and rreflection from sttructures, objectss and
peop
ple.
a Field strengths frrom fixed transsmitters, such as base stationss for radio (cellu
ular/cordless) te
elephones and land mobile rad
dios, amateur radio,
T broadcast cannot be predictted theoretically with accuracyy. To assess thee electromagnettic environmentt due
AM and FM radio bbroadcast and TV
to fixed
f
RF transm
mitters, an electromagnetic sitte survey shoulld be considereed. If the measured field strenngth in the loccation in which
h the
Pho
onak wireless Hearing Aids aree used exceeds the applicable RF compliancee level above, the
t wireless Heearing Aids sho
ould be observeed to
verify normal operration. If abnormal performancce is observed, additional meaasures may be necessary, suchh as re-orientin
ng or relocatingg the
wireeless Hearing A
Aids.
b Ovver the frequenncy range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6: Recomm
mended separattion distances between
b
portabble and mobile RF communica
ations equipmennt and the
Phonak wireless Hearin
ng Aid
The Phonak wireless Hearing Aidss are intended for use in an eelectromagneticc environment in which radiatted RF disturbances are controolled.
The customer or the user of the wireless Hearing Aids can heelp prevent electromagnetic interference by maintaining a minimum distance
betw
ween portable aand mobile RF communication
ns equipment (ttransmitters) and the wirelesss Hearing Aids aas recommendeed below, accorrding
to the maximum output power off the communications equipmeent.
Rated maximum ooutput
po
ower of transmitter
W
0.01
0.1
1
10
100
Separationn distance acco
ording to frequ
uency of transm
mitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
M
800 MHzz to 2,5 GHz
d = 1,2 P
d = 1,2 P
P
d = 2,3
2
0.12
2
0.38
8
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0
0.73
0
2.3
7.3
23
For transmitters raated at a maxim
mum output pow
wer not listed aabove, the recommended separation distancee d in metres (m
m) can be estim
mated
usin
ng the equationn applicable to the frequency of the transmittter, where P iss the maximum output power rating of the transmitter
t
in watts
w
(W) according to thhe transmitter manufacturer.
NOTTE 1 At 80 MHz annd 800 MHz, the separation distan
nce for the highe r frequency rangee applies.
NOTTE 2 These guidelines may not apply in all situations. Electromagnetiic propagation is affected by absorption and reflecttion from structu
ures, objects and
peop
ple.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 2/11
dance and M
Manufacturerr’s Declaratio
on Electrom agnetic Emissions & Imm
munity
Guid
Phon
nak ComPiloot
nt (e.g.
With the increased number of elecctronic devices such as PC’s aand other portaable and mobile radio frequenncy communicaation equipmen
mobile phones), meddical devices in use may be susceptible to eleectromagnetic interference fro
om other devicees. The use of accessories and cables
han Phonak orig
ginal parts) mayy result in increeased emissionss or decreased im
otherr than those speecified (other th
mmunity of thee unit.
The EMC
E
(Electro M
Magnetic Compaatibility) standaard IEC60601-1 -2 defines the levels of immu
unity to these eelectromagneticc interferences.. From
the other
o
hand, meddical devices must
m
not interfeere with other devices. IEC606
601-1-2 also defines the maxximum levels off emissions for these
mediccal devices. Phoonak ComPilot conform
c
to this IEC60601-1-2 standard for im
mmunity and em
mission.
Nevertheless, mediccal equipment needs
n
special precautions
p
reggarding EMC an
nd needs to be installed and put into servicce according too EMC
mation providedd in this docum
ment. This declaration currentlyy applies for thee Phonak ComPilot device.
inform
Table 1: Guidancee and manufactturer’s declarattion – electrom
magnetic emissions
The Phonak ComPilot is intended for use in the electromagnetic
e
c environment specified
s
below. The customer or the user of the
t Phonak
Com
mPilot should asssure that it is used
u
in such an
n environment.
Emiissions test
Compliance
RF emissions
e
Group 2
Th
he Phonak Com
mPilot must emiit electromagneetic energy in order
o
to
o perform its intended functiion. Nearby eleectronic equipm
ment
may
m be affected.
Class B
Th
he Phonak Com
mPilot is suitabble for use in all establishm
ments
otther than dome
estic and thosee directly connected to the public
lo
ow-voltage pow
wer supply netw
work that supp
plies buildings used
fo
or domestic purposes.
CISP
PR 11
RF emissions
e
CISP
PR 11
Electromagneticc environment – guidance
Harmonic emissionns
IEC 61000-3-2
Not applicable
Volttage fluctuationns/ flicker
emissions IEC 610000-3-3
Not applicable
Table 2: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The Phonak ComPilot is intended for use in the electromagnetic
e
c environment specified
s
below. The customer or the user of the
t Phonak
Com
mPilot should asssure that it is used
u
in such an
n environment.
Electrom
magnetic environment –
guidancce
Imm
munity test
IEC 60601 testt level
Compliance levvel
Elecctrostatic dischaarge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contactt
± 8 kV air
Elecctrical fast transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
Not applicab
ble
Not appplicable
Surg
ge
IEC 61000-4-5
± 1 kV line(s) to
o line(s)
± 2 kV line(s) to
o earth
Not applicab
ble
Not appplicable
Volttage dips, shortt
inteerruptions and vvoltage
variations on poweer supply
ut lines IEC 610000-4-11
inpu
<5 % UT (>95 % dip in UT) forr 0,5 cycle
Not applicab
ble
Not appplicable
Pow
wer frequency (550/60 Hz)
mag
gnetic field
IEC 61000-4-8
3 A/m
Floors should be wood,
w
concretee or
ceramicc tile. If floorss are covered with
synthetiic material, the relative hum
midity
should bbe at least 30 %.
%
40 % UT (60 % dip in UT) for 5 cycles
70 % UT (30 % dip in UT) for 225 cycles
<5 % UT (>95 % dip in UT) forr 5 s
3 A/m
Power ffrequency magnetic fields sh
hould
be at llevels characteeristic of a typical
locationn in a typical commercial or
hospitall environment.
NOTTE UT is the a.c. mains voltage prior to application of
o the test level.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 3/11
Table 4: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The Phonak ComPilot is intended for use in the electromagnetic
e
c environment specified
s
below. The customer or the user of the
t Phonak
Com
mPilot should asssure that it is used
u
in such an
n environment.
Immunity test
IEC 6060
01 test level
Compliance level
Electro
omagnetic enviironment – guidance
Portable and mobile
e RF communiccations equipment should be used
oser to any parrt of the Phona k ComPilot, inccluding cables, than
no clo
the reecommended se
eparation distaance calculated from the equaation
appliccable to the frequency of the ttransmitter.
Recom
mmended separration distancee
Con
nducted
RF IEC 61000-4-6
3 Vrms
150 kHz too 80 MHz
Not applicaable
Radiated
RF IEC 61000-4-3
3 V/m
80 MHz too 2,5 GHz
3 V/m
d = 1,2 P
d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 800 MHzz to 2,5 GHz
wheree P is the maxiimum output ppower rating off the transmitter in
wattss (W) according
g to the transm
mitter manufaccturer and d iss the
recom
mmended separa
ation distance iin metres (m).
Field strengths from
m fixed RF traansmitters, as determined byy an
e survey, a shoould be less th
han the compliance
electrromagnetic site
level in each frequen
ncy range. b
h the
Interfference may occcur in the vicinnity of equipment marked with
follow
wing symbol:
NOTTE 1 At 80 MHz annd 800 MHz, the higher frequencyy range applies.
NOTTE 2 These guidellines may not appply in all situations. Electromagnnetic propagation
n is affected by absorption and rreflection from sttructures, objectss and
peop
ple.
a Field strengths frrom fixed transsmitters, such as base stationss for radio (cellu
ular/cordless) te
elephones and land mobile rad
dios, amateur radio,
T broadcast cannot be predictted theoretically with accuracyy. To assess thee electromagnettic environmentt due
AM and FM radio bbroadcast and TV
to fixed
f
RF transm
mitters, an electromagnetic sitte survey shoulld be considereed. If the measured field strenngth in the loccation in which
h the
Pho
onak ComPilot is used exceedds the applicab
ble RF complia nce level abovve, the Phonak ComPilot shouuld be observeed to verify noormal
operation. If abnoormal performaance is observeed, additional m
measures may be necessary, such as re-orrienting or relo
ocating the Phonak
Com
mPilot.
b Ovver the frequenncy range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6: Recomm
mended separattion distances between
b
portabble and mobile RF communica
ations equipmennt and the
Phonak ComPilot
The Phonak ComPilot is intended for use in an electromagnetic environment in
n which radiated RF disturbancces are controlled. The customer or
the user of the Phhonak ComPilott can help prevent electromaggnetic interference by maintaining a minimuum distance bettween portablee and
mob
bile RF communications equippment (transmitters) and the Phonak ComPilot as recomme
ended below, aaccording to the maximum ou
utput
pow
wer of the comm
munications equ
uipment.
Rated maximum ooutput
po
ower of transmitter
W
0.01
0.1
1
10
100
Separationn distance acco
ording to frequ
uency of transm
mitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
M
800 MHzz to 2,5 GHz
d = 1,2 P
d = 1,2 P
P
d = 2,3
2
0.12
2
0.38
8
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0
0.73
0
2.3
7.3
23
For transmitters raated at a maxim
mum output pow
wer not listed aabove, the recommended separation distancee d in metres (m
m) can be estim
mated
usin
ng the equationn applicable to the frequency of the transmittter, where P iss the maximum output power rating of the transmitter
t
in watts
w
(W) according to thhe transmitter manufacturer.
NOTTE 1 At 80 MHz annd 800 MHz, the separation distan
nce for the highe r frequency rangee applies.
NOTTE 2 These guidelines may not apply in all situations. Electromagnetiic propagation is affected by absorption and reflecttion from structu
ures, objects and
peop
ple.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 4/11
dance and M
Manufacturerr’s Declaratio
on Electrom agnetic Emissions & Imm
munity
Guid
Phon
nak iCube
nt (e.g.
With the increased number of elecctronic devices such as PC’s aand other portaable and mobile radio frequenncy communicaation equipmen
mobile phones), meddical devices in use may be susceptible to eleectromagnetic interference fro
om other devicees. The use of accessories and cables
han Phonak orig
ginal parts) mayy result in increeased emissionss or decreased im
otherr than those speecified (other th
mmunity of thee unit.
The EMC
E
(Electro M
Magnetic Compaatibility) standaard IEC60601-1 -2 defines the levels of immu
unity to these eelectromagneticc interferences.. From
the other
o
hand, meddical devices must
m
not interfeere with other devices. IEC606
601-1-2 also defines the maxximum levels off emissions for these
mediccal devices. Phoonak iCube confform to this IEC
C60601-1-2 staandard for immu
unity and emisssion.
Nevertheless, mediccal equipment needs
n
special precautions
p
reggarding EMC an
nd needs to be installed and put into servicce according too EMC
mation providedd in this docum
ment. This declaration currentlyy applies for thee Phonak iCube device.
inform
Table 1: Guidancee and manufactturer’s declarattion – electrom
magnetic emissions
The iCube is intendded for use in th
he electromagnetic environmeent specified below. The custom
mer or the user of the iCube sh
hould assure thaat it
is used in such an environment.
Emiissions test
Compliance
RF emissions
e
Electromagneticc environment – guidance
Group 2
Th
he iCube must emit electromaagnetic energy in order to perform
its intended function. Nearbyy electronic equipment
e
mayy be
afffected.
Class B
Th
he iCube is suitable for use in all establishments other than
do
omestic and those directly connnected to the public low-volltage
po
ower supply ne
etwork that suppplies buildingss used for domestic
purposes.
CISP
PR 11
RF emissions
e
CISP
PR 11
Harmonic emissionns
IEC 61000-3-2
Not applicable
Volttage fluctuationns/ flicker
emissions IEC 610000-3-3
Not applicable
Table 2: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The iCube is intendded for use in th
he electromagnetic environmeent specified below. The custom
mer or the user of the iCube sh
hould assure thaat it
is used in such an environment.
Imm
munity test
IEC 606
601 test level
Compliance level
Electromaagnetic environ
nment – guidan
nce
Elecctrostatic
disccharge (ESD)
IEC 61000-4-2
± 6 kV contact
c
± 8 kV air
a
± 6 kV contacct
± 8 kV air
Floors shoould be wood, concrete
c
or ceramic
tile. If flooors are covered with synth
hetic
material, tthe relative humidity should be
b at
least 30 %
%.
Elecctrical fast
tran
nsient/burst
IEC 61000-4-4
± 2 kV for
f power supply lines
± 1 kV for
f input/outputt lines
± 2 kV for power supply lines
± 1 kV for inp
put/output liness
Mains poower quality sh
hould be that of a
ospital environm
ment.
typical co mmercial or ho
Surg
ge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line to
o line; 1,2/50μs
± 2 kV line to
o earth; 1,2/50μ
μs
Mains poower quality sh
hould be that of a
ospital environm
ment.
typical co mmercial or ho
Volttage dips, shortt
inteerruptions and
volttage variations on
pow
wer supply inputt
lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5
cycle
>95%; 10 mss
40 % UT (60 % dip in UT) for 5 cycles
40%; 100 ms
70%, 500 ms
<5 % UT (>95 % dip in UT) for 5 s
>95%; 5000 ms
Mains poower quality sh
hould be that of a
ospital environm
ment.
typical coommercial or ho
If the useer of the iCube requires continued
operation
during
power
m
mains
interruptioons, it is recommended thatt the
iCube be powered from an uninterrupptible
power suppply or a battery.
Pow
wer frequency
(50//60 Hz) magnettic
field
d IEC 61000-4--8
3 A/m
3 A/m
70 % UT (30 % dip in UT) for 25
cycles
Power freequency magnetic fields should be
o a typical locaation
at levels ccharacteristic of
in a tyypical commercial or hosspital
environmeent.
NOTTE UT is the a.c. mains voltage prior to application of
o the test level.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 5/11
Table 4: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The iCube is intendded for use in th
he electromagnetic environmeent specified below. The custom
mer or the user of the iCube sh
hould assure thaat it
is used in such an environment.
Immunity test
IEC 6060
01 test level
Compliance level
Electro
omagnetic enviironment – guidance
Portable and mobile
e RF communiccations equipment should be used
p
of the iCCube, including
g cables, than the
no clloser to any part
recom
mmended separation distancee calculated from
f
the equaation
appliccable to the frequency of the ttransmitter.
Recom
mmended separration distancee
Con
nducted
RF IEC 61000-4-6
3 Vrms
150 kHz too 80 MHz
Not applicaable
Radiated
RF IEC 61000-4-3
3 V/m
80 MHz too 2,5 GHz
3 V/m
d = 1,2 P
d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 800 MHzz to 2,5 GHz
wheree P is the maxiimum output ppower rating off the transmitter in
wattss (W) according
g to the transm
mitter manufaccturer and d iss the
recom
mmended separa
ation distance iin metres (m).
Field strengths from
m fixed RF traansmitters, as determined byy an
e survey, a shoould be less th
han the compliance
electrromagnetic site
level in each frequen
ncy range. b
h the
Interfference may occcur in the vicinnity of equipment marked with
follow
wing symbol:
NOTTE 1 At 80 MHz annd 800 MHz, the higher frequencyy range applies.
NOTTE 2 These guidellines may not appply in all situations. Electromagnnetic propagation
n is affected by absorption and rreflection from sttructures, objectss and
peop
ple.
a Field strengths frrom fixed transsmitters, such as base stationss for radio (cellu
ular/cordless) te
elephones and land mobile rad
dios, amateur radio,
T broadcast cannot be predictted theoretically with accuracyy. To assess thee electromagnettic environmentt due
AM and FM radio bbroadcast and TV
to fixed
f
RF transm
mitters, an electromagnetic sitte survey shoulld be considereed. If the measured field strenngth in the loccation in which
h the
iCub
be is used exceeds the applicable RF comp
pliance level abbove, the iCubee should be ob
bserved to veriify normal operation. If abnoormal
perfformance is obsserved, addition
nal measures maay be necessaryy, such as re-orienting or relocating the iCubee.
b Ovver the frequenncy range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6: Recomm
mended separattion distances between
b
portabble and mobile RF communica
ations equipmennt and the
Phonak iCube
The iCube is intendded for use in an
a electromagn
netic environmeent in which radiated RF disturbances are coontrolled. The cu
ustomer or the user
of the iCube cann help preventt electromagneetic interferencce by maintain
ning a minimu
um distance bbetween portab
ble and mobilee RF
mmunications eequipment (transmitters) and
d the iCube a s recommendeed below, acco
ording to the maximum outtput power off the
com
com
mmunications eqquipment.
Rated maximum ooutput
po
ower of transmitter
W
0.01
0.1
1
10
100
Separationn distance acco
ording to frequ
uency of transm
mitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
M
800 MHzz to 2,5 GHz
d = 1,2 P
d = 1,2 P
P
d = 2,3
2
0.12
2
0.38
8
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0
0.73
0
2.3
7.3
23
For transmitters raated at a maxim
mum output pow
wer not listed aabove, the recommended separation distancee d in metres (m
m) can be estim
mated
usin
ng the equationn applicable to the frequency of the transmittter, where P iss the maximum output power rating of the transmitter
t
in watts
w
(W) according to thhe transmitter manufacturer.
NOTTE 1 At 80 MHz annd 800 MHz, the separation distan
nce for the highe r frequency rangee applies.
NOTTE 2 These guidelines may not apply in all situations. Electromagnetiic propagation is affected by absorption and reflecttion from structu
ures, objects and
peop
ple.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 6/11
dance and M
Manufacturerr’s Declaratio
on Electrom agnetic Emissions & Imm
munity
Guid
Phon
nak myPilot
nt (e.g.
With the increased number of elecctronic devices such as PC’s aand other portaable and mobile radio frequenncy communicaation equipmen
mobile phones), meddical devices in use may be susceptible to eleectromagnetic interference fro
om other devicees. The use of accessories and cables
han Phonak orig
ginal parts) mayy result in increeased emissionss or decreased im
otherr than those speecified (other th
mmunity of thee unit.
The EMC
E
(Electro M
Magnetic Compaatibility) standaard IEC60601-1 -2 defines the levels of immu
unity to these eelectromagneticc interferences.. From
the other
o
hand, meddical devices must
m
not interfeere with other devices. IEC606
601-1-2 also defines the maxximum levels off emissions for these
mediccal devices. Phoonak myPilot coonform to this IEC60601-1-2 sstandard for immunity and emission.
Nevertheless, mediccal equipment needs
n
special precautions
p
reggarding EMC an
nd needs to be installed and put into servicce according too EMC
mation providedd in this docum
ment. This declaration currentlyy applies for thee myPilot device
e.
inform
Table 1: Guidancee and manufactturer’s declarattion – electrom
magnetic emissions
The Phonak myPiloot is intended foor use in the eleectromagnetic eenvironment specified below. The
T customer orr the user of the Phonak myPillot
should assure that it is used in such an environm
ment.
Emiissions test
Compliance
RF emissions
e
Electromagneticc environment – guidance
Group 2
Th
he myPilot must emit electtromagnetic energy in ordeer to
peerform its inten
nded function. Nearby electronic equipment may
bee affected.
Class B
Th
he myPilot is suitable for usee in all establisshments other than
do
omestic and those directly connnected to the public low-volltage
po
ower supply ne
etwork that suppplies buildingss used for domestic
purposes.
CISP
PR 11
RF emissions
e
CISP
PR 11
Harmonic emissionns
IEC 61000-3-2
Not applicable
Volttage fluctuationns/ flicker
emissions IEC 610000-3-3
Not applicable
Table 2: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The myPilot is intended for use in the electromag
gnetic environm
ment specified below.
b
The customer or the useer of the myPilo
ot should assuree
thatt it is used in suuch an environm
ment.
Imm
munity test
IEC 606
601 test level
Compliance level
Electromaagnetic environ
nment – guidan
nce
Elecctrostatic
disccharge (ESD)
IEC 61000-4-2
± 6 kV contact
c
± 8 kV air
a
± 6 kV contacct
± 8 kV air
Floors shoould be wood, concrete
c
or ceramic
tile. If flooors are covered with synth
hetic
material, tthe relative humidity should be
b at
least 30 %
%.
Elecctrical fast
tran
nsient/burst
IEC 61000-4-4
± 2 kV for
f power supply lines
± 1 kV for
f input/outputt lines
± 2 kV for power supply lines
Not applicable
Mains poower quality sh
hould be that of a
ospital environm
ment.
typical co mmercial or ho
Surg
ge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line to
o line; 1,2/50μs
Not applicable
Mains poower quality sh
hould be that of a
ospital environm
ment.
typical co mmercial or ho
Volttage dips, shortt
inteerruptions and
volttage variations on
pow
wer supply inputt
lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5
cycle
<5%; for 0,5 cycle
c
40 % UT (60 % dip in UT) for 5 cycles
40%; for 5 cycles
70%, for 25 cycles
<5 % UT (>95 % dip in UT) for 5 s
<5%; for 5 s
Mains poower quality sh
hould be that of a
ospital environm
ment.
typical coommercial or ho
If the uuser of the myPilot requires
continuedd operation du
uring power mains
m
interruptioons, it is recommended thatt the
myPilot bee powered from
m an uninterrupptible
power suppply or a battery.
Pow
wer frequency
(50//60 Hz) magnettic
field
d IEC 61000-4--8
3 A/m
3 A/m
70 % UT (30 % dip in UT) for 25
cycles
Power freequency magnetic fields should be
o a typical locaation
at levels ccharacteristic of
in a tyypical commercial or hosspital
environmeent.
NOTTE UT is the a.c. mains voltage prior to application of
o the test level.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 7/11
Table 4: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The Phonak myPiloot is intended foor use in the eleectromagnetic eenvironment specified below. The
T customer orr the user of the Phonak myPillot
should assure that it is used in such an environm
ment.
Immunity test
IEC 6060
01 test level
Compliance level
Electro
omagnetic enviironment – guidance
Portable and mobile
e RF communiccations equipment should be used
no closer to any part of the myyPilot, including cables, than the
mmended separation distancee calculated from
f
the equaation
recom
appliccable to the frequency of the ttransmitter.
Recom
mmended separration distancee
Con
nducted
RF IEC 61000-4-6
3 Vrms
150 kHz too 80 MHz
3 Vrms
d = 1,2 P
Radiated
RF IEC 61000-4-3
3 V/m
80 MHz too 2,5 GHz
3 V/m
d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 800 MHzz to 2,5 GHz
wheree P is the maxiimum output ppower rating off the transmitter in
wattss (W) according
g to the transm
mitter manufaccturer and d iss the
recom
mmended separa
ation distance iin metres (m).
Field strengths from
m fixed RF traansmitters, as determined byy an
e survey, a shoould be less th
han the compliance
electrromagnetic site
level in each frequen
ncy range. b
h the
Interfference may occcur in the vicinnity of equipment marked with
follow
wing symbol:
NOTTE 1 At 80 MHz annd 800 MHz, the higher frequencyy range applies.
NOTTE 2 These guidellines may not appply in all situations. Electromagnnetic propagation
n is affected by absorption and rreflection from sttructures, objectss and
peop
ple.
a Field strengths frrom fixed transsmitters, such as base stationss for radio (cellu
ular/cordless) te
elephones and land mobile rad
dios, amateur radio,
T broadcast cannot be predictted theoretically with accuracyy. To assess thee electromagnettic environmentt due
AM and FM radio bbroadcast and TV
to fixed
f
RF transm
mitters, an electromagnetic sitte survey shoulld be considereed. If the measured field strenngth in the loccation in which
h the
Pho
onak myPilot is used exceeds the applicable RF compliancee level above, the myPilot sh
hould be observved to verify normal
n
operatioon. If
abnormal performaance is observedd, additional meeasures may bee necessary, succh as re-orientin
ng or relocatingg the myPilot.
b Ovver the frequenncy range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6: Recomm
mended separattion distances between
b
portabble and mobile RF communica
ations equipmennt and the
Phonak myPilot
The Phonak myPiloot is intended foor use in an eleectromagnetic eenvironment in which radiated
d RF disturbancces are controlled. The customer or
the user of the myyPilot can help prevent electro
omagnetic inte rference by maintaining a min
nimum distancee between porttable and mobille RF
com
mmunications eequipment (transmitters) and the myPilot as recommend
ded below, acccording to the maximum output power off the
com
mmunications eqquipment.
Rated maximum ooutput
po
ower of transmitter
W
0.01
0.1
1
10
100
Separationn distance acco
ording to frequ
uency of transm
mitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
M
800 MHzz to 2,5 GHz
d = 1,2 P
d = 1,2 P
P
d = 2,3
2
0.12
2
0.38
8
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0
0.73
0
2.3
7.3
23
For transmitters raated at a maxim
mum output pow
wer not listed aabove, the recommended separation distancee d in metres (m
m) can be estim
mated
usin
ng the equationn applicable to the frequency of the transmittter, where P iss the maximum output power rating of the transmitter
t
in watts
w
(W) according to thhe transmitter manufacturer.
NOTTE 1 At 80 MHz annd 800 MHz, the separation distan
nce for the highe r frequency rangee applies.
NOTTE 2 These guidelines may not apply in all situations. Electromagnetiic propagation is affected by absorption and reflecttion from structu
ures, objects and
peop
ple.
V3.00/22013-09/na © Phonak AG
A All rights reserved/ppage 8/11
Guidance and Manufacturer’s Declaration Electromagnetic Emissions & Immunity
Phonak PilotOne
With the increased number of electronic devices such as PC’s and other portable and mobile radio frequency communication equipment (e.g.
mobile phones), medical devices in use may be susceptible to electromagnetic interference from other devices. The use of accessories and cables
other than those specified (other than Phonak original parts) may result in increased emissions or decreased immunity of the unit.
The EMC (Electro Magnetic Compatibility) standard IEC60601-1-2 defines the levels of immunity to these electromagnetic interferences. From
the other hand, medical devices must not interfere with other devices. IEC60601-1-2 also defines the maximum levels of emissions for these
medical devices. Phonak PilotOne conform to this IEC60601-1-2 standard for immunity and emission.
Nevertheless, medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC
information provided in this document. This declaration currently applies for the PilotOne device.
Table 1: Guidance and manufacturer’s declaration – electromagnetic emissions
The Phonak PilotOne is intended for use in the electromagnetic environment specified below. The customer or the user of the Phonak PilotOne
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 2
The PilotOne must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment may
be affected.
RF emissions
CISPR 11
Class B
The PilotOne is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
No power network input
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
No power network input
Table 2: Guidance and manufacturer’s declaration – electromagnetic immunity
The PilotOne is intended for use in the electromagnetic environment specified below. The customer or the user of the PilotOne should assure
that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative 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 lines
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
No power network input
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5
cycle
<5%; for 0,5 cycle
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the PilotOne requires
continued operation during power mains
interruptions, it is recommended that the
PilotOne
be
powered
from
an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3 A/m
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 sec
No cables
40%; for 5 cycles
70%, for 25 cycles
<5%; for 5 s
No power network input
30 A/m
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
V3.00/2013-09/na © Phonak AG All rights reserved/page 9/11
Table 4: Guidancce and manufaccturer’s declara
ation – electrom
magnetic immu
unity
The Phonak PilotOnne is intended for
f use in the ellectromagnetic environment specified below. The customer oor the user of the Phonak PilottOne
should assure that it is used in such an environm
ment.
Immunity test
IEC 6060
01 test level
Compliance level
Electro
omagnetic enviironment – guidance
Portable and mobile
e RF communiccations equipment should be used
art of the PilootOne, including cables, than
n the
no closer to any pa
mmended separation distancee calculated from
f
the equaation
recom
appliccable to the frequency of the ttransmitter.
Recom
mmended separration distancee
Con
nducted
RF IEC 61000-4-6
3 Vrms
150 kHz too 80 MHz
No cables
Radiated
RF IEC 61000-4-3
3 V/m
80 MHz too 2,5 GHz
10 V/m
d = 0.35 P 80 MHzz to 800 MHz
Hz to 2,5 GHz
d = 0.70 P 800 MH
wheree P is the maxiimum output ppower rating off the transmitter in
wattss (W) according
g to the transm
mitter manufaccturer and d iss the
recom
mmended separa
ation distance iin metres (m).
Field strengths from
m fixed RF traansmitters, as determined byy an
e survey, a shoould be less th
han the compliance
electrromagnetic site
level in each frequen
ncy range. b
h the
Interfference may occcur in the vicinnity of equipment marked with
follow
wing symbol:
NOTTE 1 At 80 MHz annd 800 MHz, the higher frequencyy range applies.
NOTTE 2 These guidellines may not appply in all situations. Electromagnnetic propagation
n is affected by absorption and rreflection from sttructures, objectss and
peop
ple.
a Field strengths frrom fixed transsmitters, such as base stationss for radio (cellu
ular/cordless) te
elephones and land mobile rad
dios, amateur radio,
T broadcast cannot be predictted theoretically with accuracyy. To assess thee electromagnettic environmentt due
AM and FM radio bbroadcast and TV
to fixed
f
RF transm
mitters, an electromagnetic sitte survey shoulld be considereed. If the measured field strenngth in the loccation in which
h the
Pho
onak PilotOne iss used exceedss the applicablee RF compliancce level above, the PilotOne should be obserrved to verify normal
n
operatioon. If
abnormal performaance is observedd, additional meeasures may bee necessary, succh as re-orientin
ng or relocatingg the PilotOne.
b Ovver the frequenncy range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6: Recomm
mended separattion distances between
b
portabble and mobile RF communica
ations equipmennt and the
Phonak PilotOne
The Phonak PilotOnne is intended for
f use in an eleectromagnetic environment in
n which radiated
d RF disturbancces are controlled. The customer or
the user of the PilootOne can helpp prevent electrromagnetic inteerference by maaintaining a minimum distancee between porttable and mobille RF
com
mmunications eequipment (transmitters) and the PilotOne as recommend
ded below, acccording to thee maximum output power off the
com
mmunications eqquipment.
Rated maximum ooutput
po
ower of transmitter
W
0.01
0.1
1
10
100
Separationn distance acco
ording to frequ
uency of transm
mitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
M
800 MHzz to 2,5 GHz
d = 0.4 P
P
d = 0.7
0
0.04
0.13
0.40
1.3
4.0
0.07
0
0.22
0
0.70
0
2.2
7.0
For transmitters raated at a maxim
mum output pow
wer not listed aabove, the recommended separation distancee d in metres (m
m) can be estim
mated
usin
ng the equationn applicable to the frequency of the transmittter, where P iss the maximum output power rating of the transmitter
t
in watts
w
(W) according to thhe transmitter manufacturer.
NOTTE 1 At 80 MHz annd 800 MHz, the separation distan
nce for the highe r frequency rangee applies.
NOTTE 2 These guidelines may not apply in all situations. Electromagnetiic propagation is affected by absorption and reflecttion from structu
ures, objects and
peop
ple.
V3.00/20013-09/na © Phonak AG
G All rights reserved/paage 10/11
Statements
The Phonak wireless devices listed in the current document are a MEDICAL ELECTRICAL EQUIPMENT and need special precautions regarding
EMC and need to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT!
Warning
The Phonak wireless devices listed in the current document should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary the Phonak wireless devices listed in the current document should be observed to verify normal operation in the
configuration in which they will be used.
Declaration
The hearing aid devices under test have no essential performance.
For surveillance purposes, the audio signal was monitored at the hearing aid output.
The hearing aid accessories under test have no essential performance.
For surveillance purposes, the periodic blinking of the LED was monitored.
V3.00/2013-09/na © Phonak AG All rights reserved/page 11/11