biodex Ultra Pro Operating Instruction [en, fr]

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FN: 08-047 Rev B 12/14
BIODEX
Biodex Medical Systems, Inc.
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,=EC2'C@W,=EC2D@F?5+23=6
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 +23=6,=EC2'C@,=EC2D@F?5-  +23=6,=EC2'C@,=EC2D@F?5-
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+23=6@7@?E6?ED
67:?:E:@?@7*J>3@=D  -
67@C6'C@4665:?8-
 >A@CE2?E*276EJ ?7@C>2E:@? - .2CC2?EJ  /
/(7:,8" #" 
?E6?565,D6  ?5:42E:@?D7@C,D6 6?6C2==62?:?82?5$2:?E6?2?46 ?DECF4E:@?D +23=6'2CED2?55;FDE>6?ED 
/(7:,8!!'" " 
)6=@42E:?8E96E23=6 6:89E5;FDE>6?E  +C6?56=6?3FC8)6G6CD6+C6?56=6?3FC8  @H=6C24<5;FDE>6?E  #6G6=:?8E96+23=6  ?DE2==:?82?5,D:?8&AE:@?2=446DD@C:6D 
@@E@?EC@==6C  CE:4F=2E:?8*42??:?8C>@2C5 *:56)2:=D  625C6DEIE6?D:@?  '2A6C:DA6?D6C 
-'@=6
&D!"! 
&D "!" ! 
&D!"!
Page 4
D
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SSyy mmbbooll DDeeffiinniittiioonn
Carefully read these instructions prior to use
Caution
General Warning
General Mandatory Action
Dangerous Voltage
“On” Power
“Off” Power
Earth (ground)
Alternating Current
Fuse
USB Connector/Cable
Waste in Electrical Equipment
Date of Manufacture
Type B Applied Part
CE Mark
CE Mark for products with EC Certificate
Certified for Safety by ETL Intertek
yy
SS
Ca thdaeryllufer
notiuaC
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Type B Applied P
kraME C
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The following symbols and their associated definitions are used and implied throughout this manual.
Page 5
67@C6'C@4665:?8
NOTE: The warnings, cautions and instructions provided in this manual must be read, followed and kept available for consultation at all times. Observing the information, instructions and procedures presented throughout this manual is essential for using this product both properly and safely.
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U 7E966BF:A>6?E:DFD65:?2>2??6C@E96CE92?DA64:7:65:?E9:D@A6C2E:@?>2?F2=
E96AC@E64E:@?AC@G:5653JE966BF:A>6?E>2J36:>A2:C652?5C6DF=ED4@F=536 4@>AC@>:D65
U %6G6C=62G6A2E:6?EF?2EE6?565@?E23=6
U .96?E96E23=6:DFD65:?2H6E6?G:C@?>6?E:E:DC64@>>6?565E92EE967@@E
4@?EC@==6C364@G6C65H:E92A=2DE:43282?5D62=652DH2E6CE:89E2DA@DD:3=6
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U *:=NBF:A6>6?E6DEFE:=:DN52?DF?6>2?:OC62FEC6BF:?5:BFN52?D46>2?F6=
5@ANC2E:@?=2AC@E64E:@?7@FC?:6A2C=NBF:A6>6?EA6FEPEC65:>:?FN66E=6D CNDF=E2EDA@FCC2:6?EPEC64@>AC@>:D
U %6BF:EE6?E!2>2:D=6A2E:6?ED2?DDFCG6:==2?46DFC=2E23=6
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CAUTION: Federal Law restricts this device to sale by or on the order of a physician, sonographer or other licensed professional.
ATTENTION: La Loi Fédérale restreint cet artifice à la vente par ou sur l'ordre d'un docteur, sonographer ou d'autre professionnel agréé.
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CAUTION: Operation for 058-720: 120 VAC, 60 Hz; 058-725 230 VAC, 50 Hz.
ATTENTION: Opération pour 058-720: 120 VAC, 60 Hz; 058-725 230 VAC, 50 Hz.
WARNING: Only use approved power supplies.
AVERTISSEMENT: N'utiliser que les alimentations homologuées
Page 8
CAUTION: To avoid risk of electric shock, this equipment must only be connected to
supply mains with protective earth.
ATTENTION: Pour éviter le risque de choc électrique, cet équipement doit uniquement être connecté à un approvisionnement conduites avec la terre protectrice.
CAUTION: The plug is considered the method of disconnecting the product from main power. Do not place the product in a position where the plug is not easily accessible.
ATTENTION: Le bouchon est considérée comme la méthode de déconnexion du produit d'alimentation. Ne placez pas le produit dans une position où le bouchon n'est pas facilement accessible.
CAUTION: This product is intended to remain in one location during operation. The product is provided with wheels for relocation and should be used when performing this operation. Once positioned, engage the central locking system lever to ensure stability.
ATTENTION: Le produit est voulu rester dans un emplacement pendant l'opération. Le produit est fourni avec les roues pour la relocalisation, et devrait être utilisé en exécutant cette opération. Une personne peut déplacer le produit.
Page 9
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Page 11
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Page 12
"()3,(8:9(5++1;9:4,5:9
Fowler Back
motor controlled with infinite adjustment through 80°
Durable Hand Controller
Optional Flush-mounted Side Rails
fold beneath the table for unencumbered access
Central Floor Locking System
Leg Section
folds down for stirrup access
Page 13
 DD6>3=J2?5+23=6&A6C2E:@?
,36*(:05."/,"()3,
CAUTION: Before moving the table with a patient, make sure side rails are in the up position and restraining straps in place to secure the patient.
ATTENTION: Avant de déplacer la table avec un patient, assurez-vous que les rails latéraux sont dans les courroies hautes de position et de corps en place pour fixer le patient.
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NOTE: In addition to the central locking system, each wheel can be locked individually by stepping down on the individual wheel lock lever.
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NOTE: The control box, located underneath the tabletop, is labeled with controller specific information.
Figure 2. Hand Controller activates table positions.
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Page 14
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59:(3305.(5+#905.7:065(3**,99680,9
NOTE: The tools needed to install all table accessories are provided with the table. These include a 7/16" wrench, 9/16" wrench and a Phillips screwdriver.
66:65:8633,8
+96@AE:@?2=7@@E4@?EC@==6CFD6DE9C66D6A2C2E6C@4<6CDEJ=6A652=DE@4@?EC@=E23=6E@A96:89E +C6?56=6?3FC8)6G6CD6+C6?56=6?3FC82?5@H=6CA@D:E:@?:?8(See Figure 3.)
CAUTION: When the table is used in a wet environment, it is recommended that the foot controller be covered with a plastic bag and sealed as watertight as possible.
ATTENTION: Quand la table est utilisée dans un environnement mouillé, il est recommandé que le contrôleur de pied soit couvert avec un sac de plastique et cacheté si inattaquable que possible.
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Figure 3. The optional foot controller can be used to adjust tabletop height, Trendelenburg/Reverse Trendelenburg, and Fowler positioning.
Page 15
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Compensator
Adjustment Screw
Receiving tube
Allen Key
Release button
Adjustment Screw
Arm board tube
Angle adjustment knob
Page 16
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Figure 4. Installing the side rails.
Page 17
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Figure 5. Installing the headrest extension
Push to adjust angle.
Push to release.
Page 18
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Mounting Bracket
Mounting Bracket
Figure 6. Using a 7/16" wrench, install the two 1/4-20" hex head screws removed in step 1 through the dispenser mounting bracket and tighten to secure the paper dispenser bracket in place. Repeat steps 1 – 4 for the opposite side.
Figure 7. Place a role of paper on the paper dispenser rod and install the rod between the brackets. Press in on either spring-loaded end of the paper dispenser bar in order to slide it into the brackets.
Page 19
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Figure 8. Installing the I.V. Pole.
Page 20
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Page 21
 ''% / 
This equipment conforms to the following safety standards:
Standard
Edition and/or date
IEC60601-1-2
First edition, 2007
Table 1.1 Safety standards
Accompanying EMC Documents
This medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• Use of accessories, transducers and cables other than those specified, with the exception of
accessories, transducers and cables sold by the manufacturer of this equipment, as replacement parts
for internal and external components, may result in increased emissions or decreased immunity of
the equipment.
• The Ultrasound Table should not be used adjacent to or stacked with other equipment. If the Ultrasound Table is used while positioned adjacent to other equipment, it should be observed to verify normal operation in the configuration in which it will be used.
List of Cable Accessories
The list in Table 1.2 includes all accessory cables supplied with the Ultrasound Table for which the manufacturer of this equipment claims compliance to EN 60601-1-2 when used with the Ultrasound Table.
T
able 1.2 Ultrasound Table cables
Cable description
Part no.
Cable length
N/A
gniynapmocAc
ctnempiuqesiTh
drandaSt
10606CIE-1-2
ats
y
S1.1elbTa
stnemucDoC EMg
asgniwoll
ehtotsmr
noc
dr
nanoit
tsrFi7002,noitied
sdradna
:sdrad
ts
y
a
eta
7
acidemsiTh
eicvre stoin
•
Po
• eUs acces
rfo
the
• eTh
deentnempiuqe
cirtcelela
mr
inCM Ee th
g
indrocc a
mmocF Relibomd
el
t
asrecuds
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cabdanscerudsanrt,esirosacces
opmoc
etxed
la
etni
.tenmpiueq
esartUleblaTound ndluosh
rplaicepssdidaregrsnoi
is th
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munma
ct
mpiqesnoi
cin
cd
pese
r
se
erru
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ybdloseslcab
tlsuer
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stroottneca
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c
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c
emtcmpiueq
xe
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sin
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fo
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e htfIten
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rtUl mnor
List of Cable Accessories
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Tound ile
es uis
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rope
m
List of Cable Accessories
ccal
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Page 22
Declaration of Conformity
Emissions
Manufacturer’s declaration electromagnetic emissions
The Ultrasound Table is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrasound Table should assure that it is used in such an environment
Emission test
Compliance
Electromagnetic environment
RF emissions CISPR 11
Group 1
The Ultrasound Table generates RF energy only for its internal func­tions. Therefore, its RF emission is very low and is not likely to cause any interference in nearby electronic equipment
RF emissions CISPR 11
Class B
The Ultrasound Table is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network supplying buildings used for domestic purposes.
Immunity
Manufacturer’s declaration electromagnetic immunity
The Ultrasound Table is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultrasound Table should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 Test level
IEC 60601-1-2 Compliance level
Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 4 kV contact ± 8 kV air
Contact ± 4 kV Air ± 8 kV
Floor should be wood, concrete or ceramic tiles. If floor is covered with synthetic material, the relative humidity should be at least 30%
Declaration of Conformity
noissiEms
c
s’rer
c
f
nMa
eThsa
Ul
Tound
dnuosartUlelbTaosh
tsetnois
Em
snoissimeRF
11R PSCI
Declaration of Conformity
simec
en
g
mo
elenoitaralc
eblcle ee
es ur
dedn
is
sunidseus iti
erssuadluo
ecnail
p
Co
1puoGr
snoiss
amotricpesnteonmrnviecit
tnemnorivnenahc
mno
vneciten
g
mo
ceEl
eTh dnuosa
Ulel
nege
FRitsfhTtio
orreomtuscheT.owlbed e
tnem
FRse
rne is
r
ynoy
g
eren
likisdloisiois
ofreushe
c
alner
i -
lylik
11R PSCI
snoissimeRF
11R PSCI
BssaCl
meFRits, er
erehT. sntio
ybearnnice en
ertni
y
eThdnuosa
Ul el
u sis
idlucinng citsedom sil
es
owlcipubl - ge
vol srepow
rupcistemodr fo.sepos
likt onisd
wloyevisniosism
tenmpi
eq
c inorectely
emhlisbtasll e a ines
lebitau
ect
co
y
ect
de so
dans
s
dilbuing yiuppls
ne
y
uppl
y
s
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tsne
e thto
d eusngsdi
ytinumIm
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nMa
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m
c
en
g
mo
elenoitaralc
eledn
is cele
n ieus
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y
num
icpesnteonmrnviecitgneaom
orreomtuscheTowlbed e
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eThdnuosa
Ul l
dnuosartUlelbTaosh
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)DS(E
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eledn
is cele
n ieus
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sunidseus iti
erssuadluo
10606CIE-1-2
leveltsTe
eg4± tcaontckV
riaVk8±
icpesnteonmrnviecitgneaom
.tnemnorivnenahc
10606CIE-1-2
lev
ec
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El
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ithwderevocisro
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y
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Page 23
Immunity test
IEC 60601-1-2 Test level
IEC 60601-1-2 Compliance level
Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6
3 Vrms, 150 KHz to 80 MHz
3 Vrms, 150KHz to 80 MHz
Portable and mobile RF communications equipment should be used no closer to any part of the Ultrasound Table, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance: d = 1.2! P 150 KHz to 80 MHz d = 1.2! P 80 MHz to 800 MHz d = 2.3! P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watt (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters
(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3
3 V/m, 80 MHz to2.5 GHz
3 V/m, 80 MHz to2.5 GHz
Note 1. UT is the a.c. mains voltage prior to application of the test level. Note 2. At 80 MHz and 800 MHz, the higher frequency range applies.
Note 3. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections
from structures, objects and people
a
Field strength from mixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM or FM broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Ultrasound Table is used exceeds the applicable RF compliance levels above, the Ultrasound Table should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Ultrasound Table.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
stetyinumIm
10606CIE-1-2
leveltsTe
10606CIE-1-2
lev
ec
p
nemno
vneci
ngmo
c
tn– ecdanigu
RFdetcudnCo
00016CIE-4-6
RFdetaidRa
00016CIE-4-3
,smrV3
o tzHK150 zHM80
,m/V3
zHM80 to2.zHG5
,smrV3
zH150K to zHM80
,m/V3
zHM80 .2tozHG5
cF Relibomdnael
trPomom
onedsue bdluohstenmpi
eq
of dnuosartUlelbTaluc, in
dntioa
pe sdednemmoce reth
otel
cilppnoiqee
mofr
.rittemsna treth
onsi
cunim
yanotersoclt
pa
, thsleba cgindlu ulca cec
is dd
efre
oofy ncque
.rittemsna treth
tsidnoi
rapesdednemmocRe
d.1= !2zHK051P toM80
1.=d zHM80 P!2toM800
2.=d zHM800 P!3to2.G5
u
p
uomumixame
siPerewh
c a)Wtt (a w inrittemsna treth
dn, arertuc
una mrittemsnatr
atsidnoitraapesdednemmocre
).(m
dex
mo
sgne
sdleFi
:ec
t
zHM
zHM
zHG
gni
rrweoptuof togindrocceth
e th is dd
etemniec
rs
sa,sr
ims
gneaom
celen aby d neimretde
pmocehtnahtss elebdluosh
rcyen
eq
each
.ge
b
ehtnir ucco
y
mecnre
etIn
ll
e
iw
m
mpi
eq
setiscitgne yveur,
a
ecnailp l inevle
fo
y
iniciv
y
g
wol:bol
1etNo .c ae th isT. U 2etNo .aHzM08At
3etNo lineidu geseh. T
e
j
os,re
crustmfro
a
Fmo
thgnetr sldie
nd atsadcoabrMFor
ittemsna trF Rde
to
e
hciwhdnuosa
Ul
arepl oamro
re vto
licpp a torior pegltao vsina. m.c
q
e
rehgiheht,HzM008dna
mselin it
isllan iy
ppl
not
y
elpoepdnas tc
bs ahcu, ssrittemsna trdeix mm
tcdieprbe
ctsadcoabrVT
ru site sticengamotrcle en, asritte
del
ppe thsdeecx edes uis ec
rel pa
on
. In
l. evt les tee
ontioalic
.seilp
p
egnarycneu
ga
opaprcitgneaom
celE.onsi
enohple teioda rr
sntiota sesa
y.caurcca
iwy laciteor
d et
. Idereidsno ce blduoh syevr
alsev leec
pmo cF Rle
licp
erusael manitiodd, ade
esb o is
on iptorbsaby d etc
sion it
am, asioda rilebo mdn ladn ase
citgneaom
cele
ssessao T
inthgnetr sld
derusae me th th
e, thevo
dnuosa
Ul el
osh
e rs ahcu, s
ssece ne
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ce
ernd sntio
rutea,oidraAM nvieeudtnemnro eth inntioaclo
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eiororng int
arepl oamro
y
re vto
ehtgnitacolreosa
Ul
b
ycneqe
e
reOv
ec
rel pa
on
. In
dnuoel
. K051eg
re
,HzM08otHz
erusael manitiodd, ade
esb o is
ahtsselebdluohsshtgnertsdle
e rs ahcu, s
y
ssece ne
y
mseor
.
3na
eiororng int
Page 24
Recommended Separation Distances
Operating Temperature
Do not expose the equipment to a temperature change of more than 5° F (3° C) per hour.
Limits of low and high operating temperature ranges are 59° to 86° F (15° C to 30° C).
Recommended separation distances between portable and mobile RF communications equipment and the Ultrasound Table. Table 6
The Ultrasound Table is intended for use in the electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Ultrasound Table can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Ultrasound Table as recommended below, according to the maximum output power of the communication equipment.
Rated maximum output power of transmitter [W]
Separation distance according to frequency of transmitter [m]
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
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
arapsd
nem
cRe bTa 6leb
eTh d
osa
Ulel
is
eThersue
roermotscu
e
tsdi
tporn ee
be
ca,wolebdednemmocre
u
p
uomu
mdetRa
mmocRe
b
rop
b
c
noi
motrcle ee th ines
ednte inis
e
foerdnuosa
Ul el
hcan
tacunimomcFRelobim
ebl
cptuomumiaxme
otgnidrco
tu
aencats
n o
ara
p
natsDinoitarapeSdednem
o
acinum
cRF
ibomdnae
hich
emnoirvn eticegam
nic ietnagmo
eltenevrppelh
nd a)sre
im
(ntepmquieon it
oicatinummcoe
foerwoptup
nsa
f
y
ueqe
f
ng
rocca
secn
t
mpuqesnoe
d anosa
no ce
ecnab
is dF
teiada r
ce en
ertnmang niiantiamby
nd dnuosa
Ul el
as
.tenmpi
eq
no
]
[
re
imns
dnuo
. dlleotrn
ummnii
a
of
pow W[
mns
010.
10.
1
10
100
rFo t a adtea rsrittemsnatr
hetng iusd etamitsebe
]
zHM80 o tzkH150
1.=d P!2
120.
380.
21.
83.
12
t liso
ewot putpu omuimxa mt a
quee
o teblacipplaon itquae
zHM800 o tzHM80
1.=d P!2
120.
380.
21.
83.
12
ednemmoce re, thevo
dtet lis
rhewrettimnsarthetofy ncque
z2.o tzHM800
5
2.=d P!3
230.
730.
32.
37.
23
tee m in dec
is dntioarape sd
powputoutummxiamhetsiPer
zH
na c)
(
srte
repow
mTegnitareOp
pxetonDo
hetng iusd etamitsebe
gnitraim
rthetofrtte
1etNo dn azH M0t 8. A
2etNo elineidu geseh. T
s tce
j
os,erutcu
mofr
erutarepm
pmetaottnempiuqeehteso
quee
o teblacipplaon itquae
e th togindrocc a)
(
ttsa w inr
tais dntioa
pe se, thzH M00 8d
n
itull s a inlyppt ao n
y
mse
.elpoepdnas
ahteromfoeg
hceru
rep
rhew,rettimnsarthetofy ncque
.rertuc
una mrittemsna tr
rycne
e
rehig he thr
ecnta
n
gapor pticengamotrcle. Esn
°3(F°5
repC).hour
powputoutummxiamhetsiPer
.sliepp aegna r
dn antio
p
os
y bdtec
a isn
repow
ntioc
e r
olfostimLi
pmetgni
repohgihd
woer
°68ot°95e aresganre ruater
F).C°03otC°5(1
Page 25
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