
Declaration
of
Conformity
Manufacturer:
Address:
Model
We
classified
93/42/EEC
This
Certification
46001 : 1996
Certificate
Issued
Date:
Certification
Directive
Certificate
Issued
Date:
Place:
Date:
Numbers:
herewith
as
declaration
Number:
by:
TUV
December
No.
Number:
by:
TUV
December
declare
Class
concerning
that
IIb
is
based
of a Ouality
Q1
Product
1998
according
93/42/EEC
G1
Product
1998
Nonin
Plymouth
02
Nonin
2605
Plymouth,
USA
9500
the
aboye
and
complies
medical
on:
System
98 09
Service
to
Annex
concerning
98
12
Service
Medical,
December
Medical,
Fernbrook
mentioned
with
devices.
to
ISO
24497
005
GmbH
II,
Clause 3 of
medical
24497
004
GmbH
Inc.
Minnesota
1998
Inc.
Lane
Minnesota
product
EC
Directive
9001 : 1994/
devices.
North
55447-4755
is
No.
EN
EC
Signature:
Name:
Title:
Authorized
MPS.
Medical
Borngasse
D-35619
CH
EC
Representative:
Product
20
Braunfels,
Jerry
Zweigbaum
CEO
Service
Germany
GmbH

ABOUT
THE
MANUAL
Shaded
The
boxed
ONYX@
is a registered
The
information
is
believed
development,
make
changes
products
boxes
draw
messages
NONIN
to
be
NONIN
and
it
describes
attention
cautions
are
TRADEMARKS
trademark
isa
NONIN
in
this
accurate.
improvements
MEDICAL,
manual
In
MEDICAL,
at
any
to
contraindications,
and
notes.
important.
registered
has
the
time,
Be
of
NONIN
trademark
INC.
been
carefully
interest
INC.
reserves
in
this
manual
without
sure
MEDICAL,
of
continued
notice
warnings,
to
read
of
checked
product
the
right
and
the
or
obligation.
them.
INC.
and
to
e
E-mail:
COPYRIGHT
NONIN
2605
Plymouth,
©
(800)
mail
MEDICAL,
Fernbrook
MN
®
(612)
356-8874
e
Fax
(612)
©nonin.com e http://www.nonin.com
1998
INC.
Lane
North
55447-4755
553-9968
(USA
and
553-7807
USA
Canada)

TABLE
OF
CONTENTS.
CONTRAINDICATIONS,
CAUTIONS...
INTRODUCTION
DESCRIPTION
ONYX
AT A GLANCE.
INTENDED
OPERATING
MAINTENANCE
THEORY
SPECIFICATIONS
PARTS
WARRANTY
TROUBLESHOOTING
INSTRUCTIONS..
GETTING
LANYARD
BATTERY
INSERTING
ACTIVATING
VERIFYING
CONDITIONS
MAINTENANCE
STORAGE
MAINTENANCE
OXIMETRY............
ONYX
AND
ACCESSORIES...
TECHNICAL
STARTED......
AND
REOUIREMENTS....
REQUIREMENTS.
OF
OPERATION
AVERAGING.
ACCESSORIES
mm
WARNINGS,
USE.............
LANYARD
NEW
BATTERIES,
THE
ONYX.
OPERATION.
THAT
....
CHOICES.
SUPPORT.
AFFECT
.
LOCK.
USE.
..
GUIDE.
AND
=
COIN

Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
|.
Top
Bottom
2.
Lanyard
3.
Inserting
4.
Applying
5.
Disengage
6.
Re-engage
7.
Clean
8.
Replace
Digital
Display
Label
and
New
the
the
the
Inner
Surfaces...
the
Gripping
FIGURES
Illustration
Lock
Batteries.
ONYX.
Spring.
Spring.
.
Insert.
and
4
8
10
11
15
15
16
16
GLOSSARY
SYMBOL
Attention,
A
G-
NRTL/C
C €
DOCUMENTS
Type
Type B Equipment
PART
shock).
CANADIAN
Meets
Standards.
CE
0123
Marking
directive
devices.
BF
(Patient
both
OF
SYMBOLS
DEFINITION
Consult
Equipment:
No.
ACCOMPANYING
Isolation
STANDARDS
Canadian
indicating
93/42//EEC
OF
with
an
from
and
United
conformance
concerning
SYMBOL
F-Type
APPLIED
electrical
ASSOCIATION
States
to
medical
EC

CONTRAINDICATIONS,
CONTRAINDICATIONS:
[
Do
not
use
the
ONYX
in
[
Do
not
operate
[
Do
not
use
the
the
ONYX
ONYX
on
CAUTIONS
an
MRI
environment.
in
an
explosive
infant
or
WARNINGS,
atmosphere.
neonatal
patients.
AND
]
|
|
|
Batteries
Federal
a
physician.
Read
Oximeter.
The
of
hemoglobin
affect
Cardiogreen
concentration,
The
accurate
pulse
situations
may
Law
this
entire
ONYX
determines
functional
the
accuracy
ONYX
must
SpO2
measurement
that
©
inadequate
®
excessive
© - oximeter
limb,
leak
or
explode
(USA)
restricts
manual
the
hemoglobin,
such
as
carboxyhemoglobin
of
the
and
other
may
affect
be
able
measurement.
before
may
contribute
perfusion,
patient
and
etc.
WARNINGS:
if
used
or
CAUTIONS:
this
device
carefully
measurement.
intravascular
SpO7
to
blood
before
pércentage
Significant
dyes,
accuracy.
measure
relying
movement,
the
Verify
on
the
to
erroneous
pressure
disposed
to
sale
by
using
the
of
arterial
levels
of
dysfunctional
or
methemoglobin
depending
pulse
properly
that
nothing
SpO2
measurement.
pulse
measurement
of
improperly.
or
on
the
order
Nonin
ONYX
oxygen
saturation
may
on
the
to
obtain
is
hindering
measurement
on
the
same
]
of
the
©
Some
are:

DESCRIPTION
INTRODUCTION
NONIN
and
Oximeter
(1.3"
The
hemoglobin
pulse
(LED)
With
blinks.
or
indicator
respectively.
a
without
during
Two
MEDICAL,
the
electronics
into
one
w. x 1.3"
ONYX
displays
oxygen
rate
(© ) in
digital
displays.
each
detected
Patient
inadequate
pulse-by-pulse
AAA
and
changing
This
requiring
critical
battery
approximately
continuous
batteries
second.
for
battery
operation
are
low,
(Refer
replacement
INC
of
the
unit, the
h. x 2.2"
perfusion
patient
1,000
to
1.)
numerical
saturation
beats
per
pulse,
are
indicated
color
from
sophisticated,
visual
indication
the
user
care
cells
power
spot
between
the
digital
Page 9 for
instructions.)
has
integrated
Nonin
Model
ONYX.
and
light
values
(YSpO2)
minute
the
PERFUSION
signals
are
as
such
green
yet
of
to
perform
situations.
the
ONYX
checks!
or
battery
displays
battery
the
finger
8500
Hand
The
ONYX
is
weight
(two
for
functional
in
percentage
on
light
emitting
O
DISPLAY
graded
as
good,
by
the
perfusion
to
yellow
or
simple
technique
wave
form
signal
complex
twelve
replacement.
will
specifications
and
operate
hours
blink
signal
once
clip
held
very
oz.).
arterial
diode
marginal
red
analysis
it
of
When
per
and
sensor
small
and
provides
quality,
for
the
Page
10

9
9
9
CAUTION:
The
ONYX
and
regularity
9
%SpO2
Numeric
calculated
(Refer
averaging.)
HEART
Numeric
calculated
to
PERFUSION
Provides a visual
blinking
alerting
may
DISPLAY
LEDs
using a four
to
Page
RATE 9 DISPLAY
LEDs
by
Page
19
for
at
the
the
user
affect
the
Green
=
Yellow=
Red
=
may
interpret
as
good
display
17,
an
information
O
corresponding
SpO
good
artifact
inadequate
BATTERY LOW
Numeric
Replace
Inserting
LEDs
the
batteries
New
Batteries.
the
beat
Theory
display
eight
beat
DISPLAY
indication
to
changes
data.
signal
or
motion
perfusion
flash
once
as
value
exponential
of
Operation,
the
pulse
sliding
on
averaging.)
of
the
pulse
in
the
amplitude
marginal
signal
artifact
(green).
per
second
soon
as
of
percent
averaging
for
rate
in
averaging
signal
quality,
rate.
It
pulse
wave
signal
amplitude
amplitude
of
when
possible.
Refer
oxygen
saturation,
technique.
information
beats
per
technique.
while
is a
method
form
signal
sufficient
batteries
to
Page
amplitude
are
on
minute,
(Refer
of
that
low.
10,
e
9
FINGER
A
display
removed.
for
The
serial
indicators.
minus
ten
label
number,
REMOVAL
(-)
when
The
seconds,
on
sign
appears
the
ONYX
last
then
the
bottom
CAUTION
in
the
senses
measured
the
displays
of
the
statement
left
that
SpO
ONYX
most
the
and
go
digit
finger
pulse
blank.
lists
and
battery
the
of
the
has
been
rate
values
model
polarity
%SpO2
freeze
number,

BATTERY
Nonin
Medical,
power
the
system.
REQUIREMENTS.
Inc.
recommends
ONYX.
Two
of
these
using
AAA
batteries
are
alkaline
included
batteries
with
each
to
new
Concerning
Rechargeable
be
used.
replacement
batteries.
WARNING:
Batteries
CAUTION:
Do
not
use
charged
may
leak.
CAUTION:
Batteries
more
than
the
Use
nickel
However,
as
they
may
leak,
different
and
partially
must
be
one
month
of
Rechargeable
cadmium
rechargeable
have
or
types
removed
or
less
capacity
explode
of;batteries
charged
if
the
or
batteries
Batteries:
nickel-metal
batteries
if
cells
used
at
ONYX
may
need
than
non-rechargeable
or
disposed
at
the
the
is
leak.
hydride
more
same
same
going
batteries
frequent
of
improperly.
time
time
as
to
be
stored
may
alkaline
or
mix
the
batteries
fully
for

VERIFYING
1.
When a finger
sequence.
2.
After
completing
pulse
3.
Allow
continuous
patient's
4.
Ifthe
perfusion
5.
Ifyou
stable
refer
to
:CAUTION:
(The
ONYX
and
regularity
CAUTION:
Finger
nail
-SpO
values.
OPERATION.
is
first
inserted,
this
sequence,
(indicated
the
Perfusion O Display
are
readings,
Page
by
system
to
green-colored
pulse)
before
is
not
restricted.
unable
to
remove
23,
Troubleshooting
may
interpret
as
good
polish
may
E
the
blinking
stabilize
Perfusion O pulses
relying
achieve
the
motion
perhision
reduce
the
ONYX
executes
y
the
ONYX
begins
Perfusion O display).
by
observing
on
the
blinks
Try
another
consistent
ONYX
Guide.
displayed
yellow
finger.
green
from
the
at
least ten
or
red,
perfusion
patient's
_
artifact
(green).
light
of
sufficient
transmission
an
initialization
sensing
seconds
(consistent
values.
make
sure
pulses
finger
amplitude
and
thereby
the
with
and
affect
of
the
and
NOTE:
If
the
pulse
„will
automatically
signal
is
inadequate
power
down.
for a two
-
12
minute
period
the
ONYX

MAINTENANCE
MAINTENANCE.
The
solid-state
calibration
Field
to
open
damage
functioning
CAUTION:
A
flexible
the
CAUTION:
pomadas
(cycle).
Follow
or
periodic
repair
of
the
the
ONYX
the
ONYX
properly,
circuit
flex
circuit,
Remove
instructions
‘NOTE:
Hold
the
ONYX
«released.
STORAGE
Store
specifications.,
CAUTION:
Batteries
more
The
REQUIREMENTS.
the
ONYX
must
than
one
circuitry
within
maintenance
ONYX
circuitry
case
or
and
void
refer
connects
CAS
(Ni
battery
in
pene
top
and
two
halves
within
stated
refer
to
Page
be
removed
month
or
the
Nonin
other
is
repair
electronics.
the
warranty.
to
Page
23,
the
two
halves.
ioncieaia
diquda
10,
Inserting
bottom
together
are held
temperature
20,
Specifications.
if
the
ONYX
batteries
y
ONYX
requires
than
battery
not
possible.
If
Troubleshooting
}
DO
Opening
the
ONYX
Do
not
WED
Sige
New
Batteries.
when
the
together
may
and
is
going
leak.
by
the
humidity
to
no
replacement.
NOT
attempt
the
case
will
is
not
Guide.
twist
or
pull
see
spring
İs
flex
circuit
storage
be
stored
for
on
only.
14

SI
Retaining
groove
Distinguish
design
TO
+
Tum
the
+
Following
spring
up
and
then
past
the
finger
Onyx
the
(to
swing
DISENGAGE
bottom
arrows
get
it
out
it
forward,
cavity
THE
SPRING
side
up.
on
the
label,
of
the
retaining
bringing
MAINTENANCE
Cleaning
gently
pull
groove)
the
spring
the
and replacing
spring
for
proper
A
RE-ENGAGE
+
To
clean
+
To
replace
+
To
replace
CHOICES.
M
the
the
the
the
inner
THE
139º — |
ACTUAL
SIZE
amman
surfaces.
spring.
gripping
spring
SPRING
insert
and
Г
TO
CLEAN
THE
INNER
SURFACES:
+
Wipe
exposed
soft
cloth
dampened
isopropyl
alcohol
mild
detergent
with a soft
dry
should
dry
the
lhe old
the
ends
the
finger
insert
secure
fit
to
however
from
surfaces
solution
solution
cloth
or
be
before
spring
spring,
of
the
cavity,
TO
adhered
the
finger.
Nonin
a
an
‘ora
+
Dry
to air
+
Surfaces
thoroughly
re-engaging
q
一
+
Remove
J - insert
past
(
A
gripping
more
insert,
operation,
Carefully
peel
surface
the
gripping
+
Carelully
peel
the
any
the
backing
the
old
residual
paper
new
insert
+
Remove
+
Peel
+
Position
X
insert.
with
with
allow
Bottom
Hatt
TO
REPLACE
caretully
pulling
new
spring
into
then
seat
the
spring
REPLACE
THE
to
the
upper
The
Onyx
recommends
thal
gripping
insert
adhesive
with
off
the
new
as
shown above
an
gripping
2
THE
SPRING:
the
ends
from
the
pivot
holes
into
the
GRIPPING
interior
surface
will
function
the
insert
be
away
from
the
isopropyl
alchohol
insert,
and
gently
Top
SN
Circuit
the
pivot
holes
on
and
swing
the
retaining
groove.
INSERT:
of
the
Onyx
or
without
in
place
during
surface
solution.
it
in
place
provides
the
the
with
uncovering
press
Halt
Gripping
Insert
either
side
spring
up
and
a
gripping
normal
(Top
Half)
Front
Edge
adhesive
back

THEORY
OXIMETRY.
The
pulse
oximeter
detects
the
fluctuating
ratio
of
the
fluctuation
determines
venous
affect
cause
The
producing
manufacturing
Note
light
Characteristics
min
change.
not
light
component
approximate
closely
if
the
the
oxygen
blood
flow,
the
saturation
fluctuations.
function,
f,
the
light.
that
the
oximeter's
intensity,
and
max
material
rather
proportionally,
However,
display
values.
(red
and
infrared),
of
blood.
functional
approximate
dysfunctional
does
such
OF
shines
red
and
signals
caused
of
the
red
saturation
skin
thickness,
reading
because
depend
on
These
physical properties
and
processes.
sp
=4
readings
upon
the
as
thick
skin
if
too
little
Pulse
oximeters
providing
The
oximeter
oxygen
laboratory
hemoglobin
OPERATION
infrared
by arterial
and
infrared
content.
finger
nail-thickness,
they
are
the
physical
min
)
max
min
AL
dø
not
depend
fluctuations
or
skin
pigmentation
thus
the
ratio
light
passes
use
two
the
ability
is
calibrated
saturation
instrument
saturation
values.
light
through
blood
light
signals
Conditions
constant
properties
are
fixed
upon
in
light
intensity.
min/max
through,
the
different
to
determine
to
closely
These
functional
levels
are
negligible.
the
tissue
pulses.
The
received
such
as
steady
etc.,
do
not
and
do
not
of
the
LEDs
by
the
the
absolute
will
affect
the
does
not
oximeter
will
wavelengths
one
values
will
saturation
values
and
of
In
summary,
internal
software
calibration
because
is
needed.
the
oximeter performs
and
there
are
no
critical
17
all
computations
parts
to
drift,
no
re-
from
the

If
the
dysfunctional
methemoglobin,
displayed
determined
dysfunctional
with
by
the
following
the
by
the
hemoglobin
hemoglobin
the
difference
oximeter
and
laboratory
formulas:
is
carboxyhemoglobin
between
the
oxygen
instrument
levels
rise
approximately
Where:
the
oxygen
saturation
will
be
or
saturation value
values
greater
as
the
in
accordance
SpO2=
Sa0)=
O2Hb+COHb+MetHb
區
O,Hb
100-
СОНЬ-
Example
O2Hb
COHb = 0.5
MetHb = 0.6
SpO2
SaO2
Мань.
1
=96
=97
=97.07
SpO2=
O2Hb = Fractional
)
COHb = Carboxyhemoglobin
MetHb = Methemoglobin
SaO2 = Functional
ONYX
numerically
saturation
saturation
in
percent
percent
percent
Example
,;
O2Hb = 88
COHb
MetHb = 2
SpO2
SaO2
determined
displayed
in
percent
oxyhemoglobin
in
percent
saturation
oxygen
2
=8
=98
=97.78
and
oxygen
saturation
in
saturation
in
18

1,
Oxygen
Saturation
Range
2.
Pulse
Rate
3.
Displays
a)
Patient
b)
Digital
4.
Measurement
Wavelengths
a)
Red:
b)
Infrared:
5.
Accuracy
a)
%SpO)
&1SD)
b)
Rate
6.
Temperature
a)
Operating
b)
Storage/
Transportation
7.
Humidity
a)
Operating
b)
Storag/
Transportation
8.
Power
Reguirements
9.
Battery
Life
a)
Operating
b)
Storage
10.
Patient
11.
Leakage
12.
Dimensions
13.
Weight
SPECIFICATIONS
Range
Indicators
Displays
Accuracy
Accuracy
Isolation
Current
0
to
100%
18
to
300
pulses
Tri-color
Two
660
910
70-100% + 2
+3% + |
32°F
-4°F
3-digit
Nanometers
Nanometers
to
to
10
to
90%
10
to
95%
Two
AAA
perfusion
7-Segment
digits
digit
122°F
(0°
122°F
(-20°
Non
Non
Cells
Approximately
operation“
Three
months?
Not
Applicable
Not
Applicable
13"Wx13"Hx2.2"L
5.7
Cmx
Two
alkaline
Cm)
ounces
batteries
(60
per
minute
light
emitting
LEDs
to
+50°C)
to
+50°C)
Condensing
Condensing
twelve
hours
gm),
including
diode
of
continuous
(3.3
Cmx
two
(LED)
3.3
AAA
=
Standard
these
limits.
Using 2 AAA
Deviation
alkaline
(S.D.):
Up
batteries.
to
32%
20
of
the
readings
may
fall
outside

PARTS
PARTS.
AND
ACCESSORIES
PART
NUMBER
1956-000
1817-000
1650-000
1966-000
2031-001
ACCESSORIES.
The following
Model
For
information
local
sales
representative
For
the
sales
at
(800)
447-ONYX.
TECHNICAL
For
technical
NONIN:
9500
BATTERY
GRIPPING
9500
EXTERNAL
LANYARD
LANYARD
accessories
9440
regarding
representative
function
Finger
parts
or
or
distributor.
SUPPORT.
support
and
before
DESCRIPTION
DOOR
INSERT
SPRING
CORD
CORD
with
the
Phantom
(oximeter
and
accessories,
distributor
returning
and
and
in
any
and
LOCK
LOCK
Nonin
your
CONTACT
(Black)
(Yellow)
ONYX:
testing
device)
contact
area
contact
equipment,
your
NONIN
call
(800)
(612)
(612)
356-8874
553-9968
553-7807
(toll
free
(local
(FAX)
21
inside
the
and
international)
U.S.
and
Canada)

WARRANTY
NONIN
ONYX
from
date
defects
of
comparable
purchaser.
remainder
NONIN
the
warranty
MEDICAL,
(excluding
defects
of
delivery.
in
material
charge.
of
of a defect
ONYX
consideration
in
NONIN
unit.
Any
the
in
question.
transferable.
Any
sign
of
tampering
entirety.
warranty
This
thereunder
are
contract,
found
for
to
tort
be
or
DISCLAIMER
THE
EXPRESS
ARE
EXCLUSIVE
KIND,
WHETHER
INCLUDING
PURPOSE
OR
INC.
(NONIN)
batteries,
material
During
or
Shipping
replacement
original
shall be
any
units
defective
by law.
lanyard
and/or
the
warranty
workmanship
reserves
within
the
costs
warranty
the
Proof
by
Nonin
with
the
sole
or
accessories
in
any
AND
EXCLUSIVITY
parts
applicable
of
the
WARRANTIES
AND
NO
OTHER
STATUTORY,
WARRANTIES
MERCHANTABILITY
wagrants
and
lanyard
workmanship
period,
to
conform
right
to
replace
are
the
responsibility
or
units
are
period.
The
warranty
purchase
occurs.
ONYX,
and
manner,
exclusive
delivered
whether
SET
FORTH
may
This
voids
WARRANTIES
WRITTEN,
OF
FITNESS
SHALL
to
the
purchaser
lock)
will
for
one
year
NONIN
to
specifications,
the
ONYX
warranted
purchaser
period,
be
required
warranty
the
warranty
remedy
by
to
the
such
OF
WARRANTY:
IN
THIS
ORAL,
that
be
free
from
will
correct
with
of
the
for
the
must
and
return
before
is
not
in
the
purchaser
purchaser
remedies
MANUAL
OF
ANY
OR
IMPLIED
the
a
notify
FOR A PARTICULAR
APPLY.
the
any
free
any
its
that
be
in
The
purchaser
repair
request
within
specification.
Non-warranty
the
time
of
the
complete
functional
agrees
on
any
work
ONYX
to
pay a $100.00
ONYX
is
charged
return
test
using
sent
to
at
the
to
NONIN.
factory
22
service
NONIN
minimum
All
test
charge
that
is
determined
repair
repairs
include
fixtures.
for a warranty
to
be
rate
effective
a
at

TROUBLESHOOTING
SYMPTOMS
Numeric
blinking
intervals.
ONYX
activate.
perfusion.
Minus
most
%SpOz
Unable
displays
at
one
will
(-)
sign
digit of
display.
to
obtain
second
not
in
the
left
green
POSSIBLE
Batteries
Batteries
inserted,
Depleted
ONYX
patient
ONYX
on finger.
Poor
Finger
ONYX
Low
strength.
Finger
Finger
positioned.
Possible
from:
©
©
©
©
Circulation
because
pressure
ONYX
surface
finger.
Excessive
Excessive
motion.
ONYX
polished
CAUSE
are
low,
incorrectly
batteries.
not
attached
turned
signal.
removal.
not
|
patient
poorly
not
correctly
interference
arterial
blood
pressure
electrosurgical
procedure
infusion
reduced
of
excess
between
and
after
ambient
patient
applied
fingernail.
to | Apply
off
while | Remove
functioning. | Call
pulse
perfused. | Reposition
catheter
cuff
line
hard
inserting
light.
to
GUIDE
POSSIBLE
SOLUTION
Replace
batteries
immediately.
9
and
Check
--|
Page 9 and
Replace
Page
patient.
finger,
finger.
Reposition
Reinsert
NONIN
Service
(800)
Reposition
finger.
finger.
Reposition
finger.
Reduce
interference.
Allow
finger
comfortably
surface.
Reduce
Reduce
Remove
polish.
See
10.
batteries.
10.
batteries.
10.
ONYX
to
See
Page
ONYX
then
reinsert
finger.
finger.
Technical
Department,
356-8874.
ONYX
ONYX
ONYX
or
eliminate
ONYX
to
rest
on
ambient
patient
fingernail
Page
See
See
11.
from
on
on
on
and
light.
motion.
23