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5.5 Physical Specificaions
Width x Height x Depth ................................. About 33x36x58mm
Weight. ........................................................ About 60g(including the batteries)
5.6 Display
20110
Display
yp
LED
t
e
SpO2%,Puls
a
.Ba
ry i
e r
te
tte
n
Display
t
conten
Ba
g
ap
r
r
h
5.7 LED Wavelengths
Probe LED Specifications
Wav
l
g
e
en
th
RED
660±6
m
n
IR
905±10
m
n
6.Technical Descri tion
The below table shows statistic conclusion of an invasive controlled desaturation study which guided by" ISO
80601-2-61,Annex EE,Guideline for evaluating and documenting SpO2 Accuracy in human subjects" .The
statistic result displayed the accuracy distribution between the range of 70%-100%,which may helpful to user.
70-80(%)
M
a
Bias(Bs)
1.94
e
n
Pr
isi
(Sr
s)
2
ec
on
e
A
u
a
y(A
ms)
1.98
cc
r
c
r
The below is the Bland-Altman graphical plot of samples from invasive controlled desaturation study.
Bland-Altman Graph for SaO2-SpO2
0.5
N
0
0
-0.5
N
0
V,
-1
C:
·.;:;
-1.5
"'
·;;
-2
0
"'
-2.5
C:
-3
V,
0
-3.5
70
60
7. Mai ntenance,clean i ng ,Disinfection
7 .1 Maintenance
The equipment's design life expectancy is about 2 years, keep your equipment and accessories free of dust and
dirt, and follow these rules:
A. Please clean the equipment before use according to chapter 6.2; Remove the batteries inside the battery
cassette if the equipment will not be operated for a long lime;
B. Replace the batteries in time when the battery voltage indicate lamps were empty;
C. It is recommended that the equipment should be kept in a dry environment with no corrosive gases and good
ventilation anytime. The moisture and high-light environments will affect its lifetime and even might damage
the equipment.
D. It is best to preserve the product in a place where the temperature is between -20 to 60°C and the
relative humidity is less than 95%.
E. The packed equipment can be transported by ordinary conveyance. The equipment can not be
transported mixed with toxic, harmful, corrosive materials.
-------------------------------------------------------------------------------------------------------------------------------
WARNING:
No modification of this equipment is allowed.
-------------------------------------------------------------------------------------------------------------------------------
7.2 Disposal
Disp
s
f
puls
xim
r i
a
rda
wi
o
e o
the
e o
ete
n
cco
nce
th
8. Cleani ng/D isi nfection
CAUTIONS
• Never immerse or soak the oximeter.
• We recommend that the oximeter be cleaned and disinfected after use every time or determined by your
hospital's policy,to avoid long term damage to the oximeter.
• Never use cleaning agents/disinfectants other than the recommended.
• The sensor component is not cleaned and disinfected during testing.
8.1 Cleaning
The recommended cleaning agents include: water
A. Shut down the pulse oximeter and remove the battery.
B. Clean the oximeter with cotton or soft cloth moistened with water.
C. After cleaning.wipe off the water with a soft cloth .
D. Allow the oximeter to air dry.
8.2 Disinfection
The recommended disinfectants include:ethanol 70%,isopropanol 70%.
A. Shut down the pulse oximeter and remove the battery.
B. Clean the oximeter as instructed above.
C. Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants.
D. After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with
water.
E. Allow the oximeter to air dry.
9.Accessories
• One lanyard
• Two AAA batteries
• One user manual
Note:
For particular configuration of accessories please refer to the product package list.
1 0.Troubleshooting
10.1 Troubleshopting
---------------------------------------------------------------------------------------------------------------------------------
WARNINGS :
eNecessary
maintenance must be performed by qualified service personal ONLY.
eusers
are NOT permitted to maintain the equipment by themselves.
eThere _
are NO replaceable component s _ in the _ equipment. ___________________________________________ ____________ _
____
Tr
ubl
P
ssibl
o
e
o
e
T
ba
i
s a
mpl
T
Oxim
a
'
u
he
tter
e
re co
he
eter c
n
t t
rn to
m
asur
m
d
A
i
c
ba
y i
e
e
o
e
n
ncorre
t
tter
T
xim
br
akd
he o
eter
e
T
display is
ff sudd
ly T
d
vi
will
u
i
he
o
en
he
e
ce
t
rn
au
ma
i
ally if
to
t
c
there
T
ba
ri
s ar
compl
he
tte
e
e
T
lumi
s
p
T
Sp
2 a
d Puls
he
ne
cent or
he
o
n
e
s
l
r
d by s
m
bj
Ra
display u
s
abl
he
te
e
o
e o
te
n
t
e
Ex
ssiv
m
v
m
ce
e
o
e
ent
di
a
,
c
tor
Radia
P
w
nt
o
er
1.8mW
2.0mW
SaO2-Radi
m
ABL800 FLEX-CO-Oxim
o
eter
eter
80-90(%)
90-100(%)
1.45
0.89
1.55
0.98
1.53
0.96
90
80
100
Mean Sao2-Spo2
l
al
vi
m
a
d was
disp
sal laws a
d
oc
en
ron
ent
n
te
o
h
re
R
as
S
lu
e
on
o
t
ly
x
aus
d
Pl
as
pla
ba
ri
ete
e
h
te
e
e re
ce
tte
e
s
alla
i
V
rify a
d
r
ba
n
t
t
on
e
n
co
rect the
w
Pl
as
a
l
al s
o
n
e
e cont
ct
oc
e
sl
p m
d
P
ss
bu
agai
nto
ee
o
e
re
the
tton
n to re
is
sig
al i
8 s
ds
xim
no
n
n
econ
o
eter
ly
x
aus
d
R
pla
ba
ri
s
ete
e
h
te
e
ce
tte
e
l
ri
wi
d
w is
C
k
lumi
s
hotoe
ect
c
n
o
hec
the
ne
cent
wi
d
w
ect
n
o
S
p movi
g fi
g
r,
a
to
n
n
e
h
n
Tr
ubl
o
e
T
Sp
2 a
d PR ar
he
o
n
e
display
d
ormally
not
e
n
Appendix A
The equipment complies with the requirement of standard EN60601-1-2 "Elecrtromagnetic
Compatibility-Medical Electrical Equipment".
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the Pulse Oximeter should ensure that it is used in such an environment.
Immu
i
y
s
n
t
te
t
r
s
a
i
dis
a
El;
ect
o
t
t
c
ch
(ESD) IEC 61000-4-2
70-100(%)
P
w
fr
qu
y
o
er
e
enc
1.4
(50/60Hz) mag
i
net
c
1.53
NOTE UT is
a.
. mai
the
c
1.52
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the Pulse Oximeter should ensure that it is used in such an environment.
Mean+2SD
Immu
i
y
s
n
t
te
t
C
du
d RF
on
cte
IEC 61000-4-6
Radia
d RF
te
IEC 61000-4-3
110
NOTE 1 A
80 MHz a
t
NOTE 2 T
s
guid
he
e
e
r
fl
i
fr
m s
ru
e
ect
on
o
t
ct
Guidance and manufacturer's declaration - electromagnetic emissions
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer or the user of the Pulse Oximeter should ensure that it is used in such an environment.
Emissi
s
s
on
te
t
RF
missi
s
e
on
CISPR 11
RF
missi
s
e
on
CISPR 11
Ha
m
i
missi
s
gula
i
s.
r
on
c e
on
t
on
I EC 61000-3-2
V
l
ag
flu
ua
i
s
o
t
e
ct
t
on
fli
k
missi
s
c
er e
on
IEC 61000-3-3
Recommended separation distances between portable and mobile RF communications equipment and the
T
Puls
Oxim
r is i
he
e
ete
a
ll
d. T
re contro
e
he c
i
f
r
by mai
nter
e
ence
(
ra
smi
rs) a
d
t
n
tte
n
the
mmu
i
a
i
s
quipm
co
n
c
t
on
e
Ra
d maximum
u
te
o
t
p
w
f
a
smi
o
er o
tr
n
tter
0,01
0, 1
1
10
100
F
r
ra
smit
rs ra
o
t
n
te
te
m
t
rs (m)
an b
stimat
e
e
c
e e
maximum
u
pu
p
w
o
t
t
o
NOTE 1 A
80 MHz a
t
NOTE 2 T
s
guid
he
e
e
r
fl
i
f
m s
u
e
ect
on
ro
tr
ct
11. Applicable models
2011 0(FS1 OE)
Notes:
1. The illustrations used in this manual may differ slightly from the
i
on
appearanceof the actual product.
s
2. The specifications are subject to change without prior notice.
ri
s i
s
alla
i
tte
e
n
t
t
on
rvi
ce
a
iva
ct
te the
a
d p
l
i
n
hotoe
ectr
c
d a
d b
dy
n
o
((�))
d =[�]✓P
d =[�]✓P
P
ssibl
R
as
o
e
e
on
T
fi
g
is
pla
d i
sid
d
p
ug
he
n
er
not
ce
n
e
ee
eno
h
Fi
g
siz
is
wi
i
mm
d
d
n
er
e
not
th
n the reco
en
e
a
g
r
n
e
Ex
ssiv
ambi
lig
ce
e
ent
ht
Puls
ra
valu
f
y
li
al flu
ua
i
s
e
te
e o
the c
c
c
ct
t
on
T
fi
g
r is
p
p
rly p
si
i
d
he
n
e
not
ro
e
o
t
one
T
pa
i
's SpO2 is
l
w
b
d
he
t
ent
too
o
to
e
etecte
Guidance and manufacturer's declaration - electromagnetic immunity
IEC 60601
C
mplia
o
nce
s
l
v
l
l
v
l
te
t
e
e
e
e
Fl
s s
oor
g
+8kv
a
+8kv
a
r
e
cont
ct
cont
ct
+BkV +1skV air fl
rs a
oo
+BkV +1SkV ai
-
' -
-
' -
r
um1d1
h
P
w
r fr
o
e
a
a
30A/m
30A/m
ch
r
cter
fi
ld
e
mm
co
s v
l
ag
pri
r
appli
a
i
f
s
l
v
l.
n
o
t
e
o
to
c
t
on o
the te
t
e
e
Guidance and manufacturer's declaration - electromagnetic immunity
C
mplia
IEC 60601
o
nce
El
c
e
l
v
l
s
l
v
l
te
t
e
e
e
e
P
abl
a
d m
ort
e
n
b
us
d
l
s
3V
ms
3V
ms
e
e
no c
o
r
r
Oxim
r, i
ludi
150 kHz
150 kHz
ete
nc
to
to
s
pa
a
i
dis
e
r
t
on
t
80 MHZ
80 MHZ
f
qu
to the
re
enc
P
d =[
3
.5]✓
v,
10 Vim
10V/m
80 MHz t
o
2,7GHz
800MHz
W
P is
here
the
a
smi
r i
wa
tr
n
tte
n
ma
ufa
u
r a
n
ct
re
dis
a
i
m
t
nce
n
etre
a
smi
rs, as d
tr
n
tte
d 800 MHz,
ig
f
qu
y
a
g
appli
s.
n
the h
her
re
enc
r
n
e
e
li
s may
apply i
all si
ua
i
s. El
r
mag
ne
not
n
t
t
on
ect
o
net
ur
s,
bj
s a
d p
pl
.
e
o
ect
n
eo
e
C
mplia
El
c
r
mag
o
nce
e
t
o
net
T
Puls
Oxim
r us
s RF
rgy
G
up 1
he
e
ete
e
ene
ro
T
fo
, i
s RF
missi
s a
v
here
re
t
e
on
re
e
i
f
r
i
arby
l
r
i
nter
e
ence
n ne
e
ect
on
c e
Class B
T
Puls
Oxim
r is sui
abl
f
r us
he
e
ete
t
e
o
i
ludi
g d
m
s
i
s
ablis
m
s a
nc
n
o
e
t
c e
t
h
ent
l
w-v
l
ag
p
w
r supply
w
rk
N/A
o
o
t
e
o
e
net
o
purp
s
s.
o
e
N/A
Medical PULSE OXIMETER
d
d f
r us
i
a
l
c
r
mag
ic
viro
nten
e
o
e
n
n e
e
t
o
net
en
us
m
us
f
M
di
al Puls
Oxim
to
er or the
er o
the
e
c
e
ai
i
g a mi
imum dis
a
b
w
p
abl
a
nt
n
n
n
t
nce
et
een
ort
e
Puls
Oxim
as r
mm
d
d b
l
w, a
e
eter
eco
en
e
e
o
cco
.
ent
S
pa
a
i
dis
a
a
di
g
e
r
t
on
t
nce
ccor
n
to
pu
t
150 kHz
80 MHZ
80 MHZ
to
to
(W)
V,
0.12
0.04
0.12
0.37
1.17
0.35
3.7
1.11
11.7
d at a maximum
u
pu
p
w
r
lis
d ab
v
,
o
t
t
o
e
not
te
o
e
the reco
d usi
g th
qua
i
n appli
able
th
frequ
e
n
e e
t
o
c
to
e
r
a
i
g
f
tra
smi
r i
wat
s (W) a
rdi
g
e
r
t
n
o
the
n
tte
n
t
cco
n
d 800 MHz,
s
pa
a
i
dis
a
f
r
ig
n
the
e
r
t
on
t
nce
o
the h
her
li
s may
apply i
all si
ua
i
s. El
mag
ne
not
n
t
t
on
ectro
net
u
s,
bj
s a
d p
pl
.
re
o
ect
n
eo
e
E,
S
lu
i
o
t
on
Pla
fi
g
p
p
ly a
d
ry agai
.
ce the
n
er
ro
er
n
t
n
C
a
g
a
fi
g
r
h
n
e
nother
n
e
Av
id
x
ssiv
lig
o
the e
ce
e
ht
T
m
asur
m
is
mal.a
d
he
e
e
ent
nor
n
the
pa
i
is ar
y
mia.
t
ent
rh
th
Pla
fi
g
r p
p
ly a
d
ry agai
.
ce the
n
e
ro
er
n
t
n
d
T
y agai
,GO
a
spi
al f
r a diag
sis
r
n
to
ho
t
o
no
if y
u ar
su
d
vi
w
rks all rig
o
e
re the
e
ce
o
ht
El
mag
i
vi
m
-guida
ectro
net
c en
ron
ent
nce
uld b
w
?d,
�mi
il
.If .
ho
e
o
concret
.
e or cer
c t
e
v
d wi
sy
i
ma
nal,
la
iv
re co
ere
th
nthet
c
te
the re
t
e
y s
uld b
a
l
as
30%
t
ho
e
t
e
t
qu
y mag
i
fi
lds s
uld b
a
l
v
ls
e
enc
net
c
e
ho
e
t
e
e
is
i
f a
ypi
al l
a
i
i
a
ypi
al
t
c o
t
c
oc
t
on
n
t
c
ial
spi
al
vi
o
m
.
erc
or ho
t
en
r
n
ent
r
mag
i
vi
o
m
-guida
t
o
net
c en
r
n
ent
nce
bil
RF
mmu
i
a
i
s
quipm
s
uld
o
e
co
n
c
t
on
e
ent
ho
r
a
y par
f
Puls
e
to
n
t o
the
e
g
abl
s,
a
r
mm
d
d
n
c
e
th
n the
eco
en
e
a
al
ula
d f
m
qua
i
appli
abl
nce c
c
te
ro
the e
t
on
c
e
y
f
ra
smi
.
o
the t
n
tter
80MHz
to
800 MHZ
o
t
2.7 GHz
maximum
u
pu
p
w
a
i
g
f
o
t
t
o
er r
t
n
o
the
s (W) a
di
g
a
smi
tt
ccor
n
to the tr
n
tter
d d is
r
mm
d
d s
parati
n
the
eco
en
e
e
on
s (m). Fi
ld s
g
s f
m fix
d RF
e
tren
th
ro
e
mi
d by a
l
r
mag
i.
eter
ne
n e
ect
o
net
i
p
paga
i
is aff
d by abs
p
i
a
d
c
ro
t
on
ecte
or
t
on
n
i
viro
m
- guida
c en
n
ent
nce
ly f
i
s i
r
al fu
i
.
on
or
t
nte
n
nct
on
ry l
w a
d a
lik
ly
aus
a
y
o
n
re not
e
to c
e
n
quipm
.
ent
i
all
s
ablis
m
s,
e
n
e
t
h
ent
d
s
dir
ly
d
publi
n
tho
e
ect
connecte
to the
c
a
suppli
s buildi
gs us
d f
r d
m
s
i
th
t
e
n
e
o
o
e
t
c
m
t i
w
i
adia
d RF dis
u
ba
s
n
en
n
h
ch r
te
t
r
nce
a
lp p
v
l
mag
i
eterc
n he
re
ent e
ectro
net
c
d m
bil
RF
mmu
i
a
i
s
quipm
n
o
e
co
n
c
t
on
e
ent
rdi
g
maximum
u
pu
p
w
r
f
n
to the
o
t
t
o
e
o
the
f
qu
y
f
a
smi
(m)
re
enc
o
tr
n
tter
800 MHZ
800 MHz
2,7 GHz
to
d=[_.z_NP
E,
0.07
0.23
0.7
2.22
3.5
7.0
mm
d
d s
para
i
dis
a
d i
en
e
e
t
on
t
nce
n
n
y
f th
ansmit
e
, wh
r
P is th
e
c
o
e tr
t
r
e
e
e
ra
smi
r ma
ufa
tur
r.
to the t
n
tte
n
c
e
fr
qu
y ra
g
appli
s.
e
enc
n
e
e
i
p
paga
io
is aff
d by abs
p
i
a
d
c
ro
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