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User Manual for Fingertip Oximeter
I
Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please
read the manual very carefully before using this device.
Failure to follow these instructions can cause measuring
abnormality or dama ge to the oximeter.
The manual is published in English and we have the
ultimate right to explain the Manual. No part of this
manua l may be phot ocopie d, repr odu ced or t rans lated into
another language without the prior written consent. We
reserve the right to improve and amend it at any time
without prior notice.
Version of the Manu al: Ver 1.0
Revised date: October 24, 2012
All rights reserved .
3502-2290052
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User Manual for Fingertip Oximeter
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Warnings
Check the device before using it to make sure
that there is n o visible d amage which may affect
user’s safety or its performance with regard to
sensors and clips. It is recommended that the
device should be inspected minimally once a
week. When there is obvious damage, stop using
the device.
Special attention should be paid while the
oximeter is used constantly under the ambient
temperature over 37°C, burning hurt may occur
because of over-heating of the sensor at this
situation.
An uncomfortable or painful feeling may appear
if the oximeter is used continuously on the same
place for a long time, especially for poor
microcirculation patients.
It is recommended that the oximeter should not
be applied to the same location for longer than 2
hours. If any abnormal condition is found, please
change the placing site of oximeter.
Avoid pla cin g th e d evic e on th e s ame limb which
is wrapped with a cuff for blood pressure
measurement or during venous infusion.
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DO NOT clip this device on edema or tender
tissue.
The light (the infrar ed li ght is invisible) emitting
from the device is harmful to the eyes, so service
technician or test ee should not star e at the light.
The oximeter is not a treatment device.
When disposing of this device and its
accessories, the local law should be followed.
Instructions for Operation
The finger should be put in properly and correctly.
Do not shake the finger. Keep at ease during
measurement.
Do not put wet finger directly into sensor.
Do n ot let anythin g block the emittin g light from
the device.
Ensure that there is artery vessel within
mea su r i ng site where the light transmits th r o ugh.
Vigorous exercise and the interference from the
electrosurgical device may affect the measuring
accuracy.
Nail polish may affect the measuring accuracy,
and too long fingernail may cause failure of
measurement or inaccurate result.
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Keep the oximeter away from dust, vibration,
corrosive substances, explosive materials, high
temperature and moisture.
Existen ce of high intensi ve light sources, such as
fluorescence light, ruby lamb, infrared heater or
strong sunshine, etc. may cause inaccuracy of
measurement result. Please put an opaque cover
on the sensor or change the measuring site if
necessary.
If the first reading appears with poor waveform
(irregular or not smooth), then the reading is
unlikely true, the more stable value is expected
by waiting for a while, or a restart is n eeded when
necessary.
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User Manual for Fingertip Oximeter
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Declaratio n of Conformity:
The manufacturer hereby declares that this
device complies with the following standards:
IEC 60601-1
IEC 60601-1-2
ISO 9919
and follows the provisions of the council
directive
MDD 93/42 EEC
Caution:
U.S. federal law restricts this d evice to sale or
use by or on the order of a physician.
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Content
1 Overview ..................................................................... 1
1.1 Appe aran ce ........................................................... 1
1.2 N a me and Model .................................................. 2
1.3 Intended Use ......................................................... 2
1.4 Structure and Conformatio n ............................... 2
1.5 Fe at ures ................................................................. 2
2 Batt e ry Installatio n ..................................................... 3
3 Operatio n .................................................................... 4
3.1 Directly Measurement .......................................... 4
3.2 Ov e r-limit indication and Beep Silence ............... 8
3.3 Setup Me nu Scre en ............................................... 9
3.4 Data transmission ............................................... 10
4. Techn i c a l S p e cifications .......................................... 11
5. Accessories ............................................................... 13
6. Repair and Maint e nance ......................................... 13
6.1 Oximeter Maint enan c e ....................................... 13
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6.2 C leaning and Disi nfect ing Instru c tion .............. 15
7. Troubleshooting ....................................................... 16
Appendix ...................................................................... 17
A. Key of Symbols ..................................................... 17
B. SpO2 Common Knowled ge .................................... 18
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1 Overview
1.1 Appe aran ce
Figure 1 Front/Rear View
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1.2 N a me and Model
Name: Fingertip Oximeter
Model: PC-60NW
1.3 Intended Use
This Fingertip Oximeter is intended for measuring the
pulse rate and functional oxygen saturation (SpO
2
)
through patient’s finger. It is applicable for spot-checking
SpO
2
and pulse rate of adult and pediatric patients in
homes and clinics.
1.4 Structure and Conformation
It consists of main unit and photoe lectric sensor.
1.5 Features
• Wireless data transmission can communicate with
PC/mobile phone/PDA.
• Large true color OLED display of SpO
2
, PR Pulse
Bar, PI & Plethysmogra m
• I nnovative 4 directions display
• Automatic power on/off
• Audible & visible over-limit indication, hi gh & low
limits are adjustab le
• S h ift parameter d is play be tw e en PR and PI
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• 2AAA alkaline batteri es with low power consu mption
• Low batt ery voltage indi cation
2 Battery Installation
Figure 2 Battery Installation
1. Refer to Figure 2, insert t wo AAA size batter ies into
the batter y com pa rtme n t pr operly.
2. Repla ce the cover.
Please make sure that the batteries are c orrect ly
installed since the incorrect installation may
cause the device inoperable.
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3 Operation
3.1 Directly Measurement
1. Ope n t he c l i p a s shown in Figure 3.
Figure 3 Put finger into the Oximeter
2. P ut fin ger int o t he rubb er cushions of the c lip (make
sure the finger is in the correct position), and then
clip the finger.
3. The de vice will p ower on automatically in 2 seconds,
and st a rt to display sof tware ver sion numbe r.
4. Next enter into data display screen (as shown in
Figure 4). The user can read th e values and view th e
waveform from display screen.
Shift parameter display between PR and PI during
measurement:
Short time press Disp lay Key, t he display orientation will
rotate 90 degree, at the same time, PR value shift to PI
value automatically and there is no waveform displayed as
shown in 4B. But if no operation is performed during the
first 20 seconds, the PI value will change to PR value
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automat ically as shown in figure 4C. Press the key again ,
the screen will change its direction as shown in 4D. It
obviously shows that the alternative display between
parameter PR and PI is under the condition that the
direction of screen is rotated to the left and right side,
which is accompanied by no waveform displayed as
shown in 4B and 4 E. After 20 se conds without operation,
the PI wi ll a utom atic ally s hi ft back to PR, as sh own in 4 C
and 4F.
Figure4A Figure4B
Figure4C Figure4D
Figure4E Figure4F
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Screen Description:
“%SpO
2
”: SpO2 symbol; “99”: SpO2 value;
“PR”: Pulse Ra te ic on; “65”: Pulse Rate value;
“
”: Puls e be at symbol ;
“
”: Pulse intensity bar graph;
“PI%”: Perfusion index icon; “1.4”: Perfusion
Index value;
“
”: Wireles s symbol.
Wireless icon“
”:
The color of “ ”
Definition
“ ” fl a s hes blue
The device is being to establish
a wireless connection with the
surrounding host.
“ ” long lights blue
Successful wireless connection
between the device and a host is
established.
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No display“ ”icon
1.
"Wireless" function is
disabled;
2.
The device fails to setup a
wireless connect
ion with the
surrounding host
within 3
minutes;
3. Hardware failure of wireless
transmi ssi on functi on while the
“Wireless” function is enabled.
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3.2 Over-limit indication and Beep Silence
When measuring, if SpO
2
value or pulse rate value
exceeds the preset alarm limit, the device will beep
automat ically and th e value which ex ceeds limit on the
screen will flash. The detailed information refers to
chapter 4.
When th e beep s ound is activat ed by over-limit, it will
become silent at the following situations:
1. The SpO
2
and PR value retur n to normal range.
2. Press Display Key to mute. If this over-limit
event continues, the oximeter will resume beeping
automatically later in 2 minutes.
3. Remove the finger from the oximeter or SpO
2
probe.
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3.3 Setup Menu Screen
Fig ur e 5 Menu Screen
Long time pressing display key could enter the setup
men u screen.
Setup Menu Screen Description：
“Wireless”
：
The wireless on-off button. There are 2
selectable options: “on” and “off”. The device transmits
data to PC w hen it is on.
“SpO2 alm Lo”：SpO2 low limit. The us e r c an modify
the value within 85~99 with “1” as a step.
“PR alm Hi”
：
Pulse Rate high limit. The user can
modify the value within 100~240 with “5” as a step.
“PR alm Lo”
：
Pulse Rate low limit. The user can
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10
modify the value within 30~60 with “1” as a step.
“Save, exit menu”
：
Longtime pressing this item to
store settings and exit to the normal display screen
from the setup menu.
On setup menu screen:
1. Short time press Display Key to choose the
setting item;
2. Longtime press Display Key to activate the
setting item, then short time press it to modify the
setting parameter ;
3. Next, longtime press Display Key to confirm the
modification and exi t from this setti ng item.
4. At last, move the setting item to “Save, exit
menu”, and long time pressing Display Key to
store the modification and exit from the setup
menu.
3.4 Data transmission
This oximeter has the feature of wireless data
transmission，the display reading can be transmitted to
a computer effectively via the wire less communication
function. Refer to the manual “Oximeter Data
Manager” for detailed information.
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4. Technical Specifications
A. SpO2 measurement
Technique:
dual-wavelength LED sensor with wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maximal optical output power: <= 1.5mW
Measuring range: 35%~100%
Mea su ring ac curacy:
A
rms
<= 3% for SpO2 range from 70% to 100%
Not e: A
rms
is defined as root-mean-square value of
deviation according to ISO 9919.
SpO
2
low limit setting range: 85%~99%
B. Pulse Rate measurement
Measuring range: 30bpm~240bpm
Measuring accura cy: ±2bpm or ±2% (whicheve r is
greater)
Pulse Rate limit setting range:
high limit: 100~240bpm
low limit: 30~60bpm
C. Perfusion Index (PI) Display
Range: 0.2%~20%
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D. Audible &visual over-limit indication
Whe n measu ring, if SpO
2
va lu e or pu ls e r at e va lu e
exceeds the preset limit, the device will beep
automatically and the value which exceeds limit
on the screen will flash. The oximeter will shut
down automatically in 8 seconds with no signal.
E. Display mode
：
Color OLED Display
F. Power suppl y requirement :
2 x LR03 (AAA) alkaline batte ries
Supply voltage: 3.0VDC
Operating cur r ent: ≤40mA
G. Environment requirement
Operating Tempera t ure: 5 ~40°C
Operating Humidity: 30~80%
Atmospheric pressure: 70~106kPa
H. The performance under low perfusion condition
The accuracy of SpO
2
and PR measurement still
meets the specification described above when the
pulse modulation amplitude is as low as 0.6%.
I. Resistance to interference o f surroun d ing light:
The difference between the SpO
2
value measured
in t he conditi on of indoor n atural li ght and th at of
darkroom is less than ±1%.
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J. Dimensions: 60 mm (L) × 33 mm (W) × 30 mm (H)
Net W e ight: 35g (including battery)
K. Classification:
The type of protection against electric shock:
Internally powered eq uipment.
The degree of protection against electric shock:
Type B F applied parts.
The degree of protection against harmful ingress
of liquids: Ordinary equipment without protection
against ingress of wat er.
Electro-Magnetic Compatibility: Group I, Class B
5. Accessories
A. A lanyard
B. T wo batteries
C. A pouch
D. A Use r Manual
E. Quality Certificate
Note: The accessories are subject to change. Detailed
items and quantity see the Packing List.
6. Repair and M aintenance
6.1 Oximeter Maintenance
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The service life (not a warranty) of this device is 5
years. In order to ensure its long service life, please pay
attention to the use of maintenance.
P lease cha nge th e batteries when the low-voltage
indicator lightens.
Please clean the surface of the oximeter before
use. Use soft cloth with alcohol to wipe the
oximete r first , and then let it dr y in air or wipe it
dry.
Please take out the batteries if the oximeter will
not be used for a long time.
The recommended storage environment of the
device:
ambient tem pera tur e: -20ºC ~60ºC,
relative humidity 10%~95%,
atmo sp heric pre ss ure: 50 kPa~107.4kPa.
The oximeter is calibrated in the factory before
sale, so there is no need to calibrate it during its
life cycle. However, if it is necessary to verify its
precision routinely, the user can do the
verification by means of SpO
2
si mulator, or it can
be do ne by the lo c a l th ird party te s t ho use.
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Necessary servicing must be performed by
qualified service engineers ONLY. Users are not
permitted to maintain it by themselves.
High-pressure sterilization cannot be used on the
device.
Do not immerse the device in liquid.
6.2 Cleaning an d Disinfec ting Instruct ion
Surface-clean sensor with a soft cloth by wetting
with a solution such as 75% isopropyl alcohol, if
low-level disinfection is required, use a 1:10
bleach solution.
Then surface-clean by soft cloth wet with clean
water an d let air dry or wipe it dry.
Caution: Do not sterilize by irradiation steam, or
ethylene oxide.
Do not use the sensor if it is damaged.
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7. Troubleshooting
Trouble Possible Reason Solution
The SpO2
and Pulse
Rate display
instable
1. T he fing er is
not placed far
eno ug h inside.
2. T he fing er is
shaking or the
patient is moving.
1. Place the
finger correctly
inside and try
again.
2. Let th e patient
keep calm.
Cannot turn
on
the device
1. T he batteries
are drained or
almost drained.
2. T he batteries
are not inserted
properly.
3. T he device is
malfunctioning.
1. Change
batteries.
2. Reinstall
batteries.
3. Please contac t
the local service
center.
No display
1. T he device w il l
power off
automatically
when it gets no
signal for 8
seconds.
2. T he batteries
are almost
drained.
1. Norma l.
2. Change
batteries.
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No display
of the
wireless
icon
“ ”
when it is
enabled
Hardware failure
of wireless
transmission
function.
Please contact the
local service
center.
Appendix
A. Key of Symbols
Symbol
Description
With Type BF applie d part
Warning ─ See User Manu al
%SpO2 Oxygen saturation (percentage)
PR Pulse rate (beats per minute)
Pulse rate icon
Wireless icon
Low battery voltage
SN
Serial number
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B. SpO2 Common Knowledge
1. Meaning of SpO
2
SpO2 is the saturati on percent age of oxygen in th e blood,
so called O
2
concentration in the blood; it is defined by
the percentage of oxyhemoglobin (HbO
2
) in the total
hemoglobin of the arterial blood. SpO
2
is an important
physiologi c al p aram eter t o reflect the respiration function;
it is calculated by the followi ng method:
SpO
2
= HbO2/ (HbO2 +Hb)×100%
HbO
2
are the oxyhemoglobins (oxygenized
hemoglobin), Hb are those hemoglobins which release
oxygen.
2. Principle o f Me asurement
Based on Lamber-Beer law, the light absorbance of a
given subs tance is dir ect ly pr oporti on al with it s d ensit y or
concentration. When the light with certain wavelength
emits on human tissue, the measured intensity of light
after absorption, reflecting and attenuation in tissue can
reflect the structure character of the tissue by which the
light passes. Due to that oxygenated hemoglobin (HbO
2
)
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19
and deoxygenated hemoglobin (Hb) have different
absorption character in the spectrum range from red to
infrared light (600nm~1000nm wavelength), by using
these characteristics, SpO
2
can be determined. SpO2
measured by this oximeter is the functional oxygen
saturation -- a percentage of the hemoglobin that can
transport oxygen. In contrast, hemoximeters report
fractional oxygen saturation – a percentage of all
measured hemoglobin, including dysfunctional
hemoglobin, such as carboxyhemoglobin or
metahemoglobin.
Clinical application of pulse oximeters: SpO
2
is an
important physiological parameter to reflect the
respiration and ventilation function, so SpO
2
monitoring
used in t re at m en t h as b ecom e more popula r. (For ex a mp l e,
such as monitoring patients with serious respiratory
disease, patients under anesthesia during operation and
premature and neonatal infants) The st atus of SpO
2
c an be
determined in timely manner by measurement and will
allow finding the hypoxemia patient earlier, thereby
preventing or reducing accidental death caused by
hypoxia effectively.
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3. Factors affecting SpO2 measuring accuracy
(interferen ce reason)
Intravascular dyes such as indocyanine green or
methylene blue
Exposure to excessive illumination, such as surgical
lamps, bilirubin lamps, fluorescent lights, infrared
heating lamps, or direct sunlight.
Vascular dyes or external used color-up product
such as nail enamel or color skin care
Excessive patient movement
Plac ement of a sensor on an extremity with a blood
pressure cuff, arterial cathete r, or intravascular line
Exposu r e to the chamber with High pressure
oxygen
There is an arteria l occlusion proximal to the
sensor
Blood vessel contraction caused by peripheral
vessel hyperkinesias or body temperature
decreasing
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4. Factors causing low SpO2 Measuring value
(pathology reason)
Hypoxemia disease, functional lack of HbO
2
Pigmentation or abnormal ox yhemoglobin leve l
Abnormal oxyhemoglobin va riation
Methemoglobin disease
Sulfhemoglobinemia or arterial occlusion exists
near sensor
Obvious veno us pul sations
Peripheral arterial pul satio n beco m es we ak
Peripheral blood supply is not enough
Guid ance and m anufacturer’s decl ar ation
The following tables (Table 1 to 4) provide the specific
information regarding this device's compliance to IEC
60601-1-2.
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Table 1
Guid ance and m anufacturer’s decl ar ation -
electromagnetic emissi ons
The device is intended for use in the electromagnetic
environment specified below. The user of this device should
assure that it is used in such an environment.
Emissions test
Compli
ance
Electromagnetic
environment – guidance
RF emissions
CISPR 1 1
Group
1
This device uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low
and are not likely to cause
any interference in nearby
electronic equipmen t.
RF emissions
CISPR 1 1
Class B
This device is suitable for
use in all establishments,
including domestic and
those directly connected to
the public low-voltage
power supply network that
supplies buildings used for
domest ic pur po se s.
Harmonic
emissions
IEC 61000-3-2
N/A
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
N/A
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Table 2
Guid ance and m anufacturer’s decl ar ation - electromagnetic
immunity
The device is intended for use in the electromagnetic
environment specified below. The user of this device should
assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compli
ance
level
Electromagnetic
environment -
guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV
air
Fl oo r s should be
wood, c oncrete or
ceramic tile. If
floors are covered
with syntheti c
material, the
relative humidity
should be at least
30%.
Electrical
fast
transient/bur
st
IEC61000-4
-4
±2 kV for
power
supply lines
±1 kV for
input/output
lines
N/A N/A
Surge
IEC
61000-4-5
±1 kV line
(s) to line(s)
±2 kV
line(s) to
earth
N/A N/A
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24
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 c ycle
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
for 25 cycle s
<5 % UT
(>95 % dip
in UT)
for 5 s
N/A N/A
Power
frequency
(50/60Hz)
magnetic
field
IEC61000-4
-8
3 A/m 3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commer c ial
or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the
test level.
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Table 3
Guid ance and m anufacturer’s declaration – electromagnetic
immunity
The device is intended for use in the electromagnetic
environment specified below. The user of this device should
assure that it is used in such an electromagnetic environment.
Immunity
test
IEC
60601 test
level
Compli
ance
level
Electromagnetic
environment - guidance
Conducte
d RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2. 5
GHz
N/A
3 V/m
Portable and mobile RF
communications
equipment should be
used no closer to any
part of this device,
including cables, than
the recommended
separation distance
calculated from the
equation applicable to
the frequency of the
transmitter.
Recommended
separation distance
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26
Where P is the
maximum output power
rating of the transmitter
in watts (W) according
to the transmitter
manufacture r and d is
the reco mmended
separation distance in
meters (m).
Field strengths fr o m
fixed RF transmitters, as
deter mined by an
electromagnetic site
survey ,a should be less
than the compliance
level in each frequenc y
range .b
Interference may occur
in the vicinity of
equipment marked with
the following symbol.
NOTE 1 : At 80 MHz and 800 MHz, the higher frequency
range applies.
NOTE 2 : These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from st ructures, objects and people.
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27
a: Field strengths from fixed transmitters, such as base stations
for radio (ce llular / cordless) telephones and land mobi le radios,
am
ateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, and
electromagnetic site survey should be considered. If the
measured field strength in the location in which the device is
used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If
abnorm al perform ance is observed, additiona l measures may be
necessary, such as re-orienting or relocating this de vice.
b: Over the frequ ency range 150 kHz to 80 MHz, field stren gths
should be less than 3V/m.
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28
Table 4
Recommended separation distances between
portable and mobile RF communic ations equ ipmen t an d
the device
The device is intended for use in an electromagnetic
envi r o nment in whi c h radia ted RF di s turbances a r e c o ntrol led.
The user of this device can help prevent electromagnetic
interference by maintaining a minimum distance between
portable and mobile RF communications e quipment
(transmitters) and this device as recommended below, according
to the maximum output powe r of the communicati ons
equipment.
Rated
maximum
output power
of transmitter
W
Separation distance according to frequency of
transmitter
m
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GH z
0,01
N/A
0.12
0.23
0,1
N/A
0.38
0.73
1
N/A
1.2
2.3
10
N/A
3.8
7.3
100
N/A
12
23
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29
For transmitters r ated at a maximum outp ut power not list ed
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 maxi mum 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 af fected by absorption and
reflection from st ructures, objects and people.
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