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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 1.1
Revised date: July 19, 2012
All rights reserved .
3502-2290049
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Warnings
Check the device to make sure that there is no
visible damage that may affect user’s safety or
measurement 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 continuously under the ambient
temperature exceeds 37°, burnin g hurt m ay occur
because of over-heating on the s ensor.
An uncomfortable or painful feeling may appear
if using the oximeter 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 position 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 infrared light is invisible) emitted
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 the monitor 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 fin ger directly into sensor.
Avoid placi n g the d evic e on th e sa me limb whi ch
is wrapped with a cuff for blood pressure
measurement or during venous infusion.
Do not let anythi ng block the emittin g light from
device.
Vigorous exercise and electrosurgical device
interference may affect the measuring accuracy.
Using enamel or other makeup on the nail may
affect the accuracy of measurement, too long
fingernail may cause failure of measurement or
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User Manual for Fingertip Oximeter
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inaccuracy measurement result.
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 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 needed when
necessary.
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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. f ederal 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 Appearance ........................................................... 1
1.2 N a me and Model .................................................. 2
1.3 Intended Use ......................................................... 2
1.4 Structure and Conformation ............................... 2
1.5 Fe at ures ................................................................. 2
2 Batt e ry Installatio n ..................................................... 3
3 Operation .................................................................... 4
3.1 Directly Measurement .......................................... 4
3.2 Ov e r-limit indication and Beep Silence ............... 7
3.3 Setup Me nu Scre en ............................................... 8
3.4 External Sp O
2
Probe Connection ...................... 10
4. Techni c a l S p ecifications .......................................... 11
5. Accessories ............................................................... 14
6. Repair and Maint e nance ......................................... 14
6.1 Oximeter Maint enan c e ....................................... 14
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6.2 C leaning and Disi nfect ing Instru c tion .............. 16
7. Troubleshooting ....................................................... 17
Appendix ...................................................................... 18
A Key of Symbols ...................................................... 18
B SpO
2
Common Knowled ge ..................................... 19
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1 Overview
1.1 Appe aran ce
Fig ur e 1 Front/Rear View
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1.2 N a me and Model
Name: Fingertip Oximeter
Model: PC-60N
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 Conforma tion
It consists of main unit and photoelectric sensor, and
additional data upload connector.
1.5 Features
• Exter n a l pe d iatric SpO
2
probe available
• Large true color OLED display of SpO
2
, PR Pulse
Bar, PI & Plethysmogra m
• Innovative 4 directions display
• Automatic power on/off
• Audible & visible over-limit i ndication, h igh & low
limits are adjustab le
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• Shift parame te r displ ay betwee n P R a n d P I
• 2AAA alkaline batteries with low p ower consumpti on
• Low battery voltage indication
2 Battery Installation
Figure 2 Battery Installation
1. Refer to Figure2, insert two AAA size batteries into
the batter y com pa rtme n t pr operly.
2. Repla ce the cover.
Please make sure that th e batteries are correctly
insta lled, or inc orrect installation ma y cause the
device not to work.
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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. Put 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 device will power 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). User can read the values and view the
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 is shifted to
PI value automatically (as shown in 4B). When shown as
4B, the display will shift to 4C automatically after 20
seconds with out ope ration. Press t he key aga i n, t he s c reen
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will change another direction (as shown in 4D). It
obviously shows that shifting parameter between PR and
PI is under the condition of the display orientation
rotating to a side, as shown in 4B and 4E. After 20
seconds without operation, the PI will automatically shift
back to PR, as shown in 4C 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;
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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 silence at the following situations:
1. When SpO
2
and PR value return 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
menu screen.
Setup Menu Screen Description：
“SpO2 alm Lo
”
：SpO2 lower limit. The user can
modify the value within 85~99, the step is “1”, the
default is 90.
“PR alm Hi”：Pulse Rate high limit. The user can
modify the value within 100~240, the step is “5”, the
default is 120.
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“PR alm Lo”：Pulse Rate low limit. The user can
modify the value within 30~60, the step is “1”, the
default is 50.
“Pul se beep”：Pulse beep option. If it is set to on, every
pulse beat ma kes a beep , and the pitch ton e of this beep
changes a cc o rding to SpO
2
val ue (within 90~99%).
“Save, e xit me nu ”：Long time pressing this item
to store settings and exit from the setup menu to the
normal display screen.
“Restore default”：Restore default setting. Refer to
Figure 5 for each default value.
On setup menu screen:
1. Short time press Display Key to choose the
setting item;
2. Longtim e press Display Key to acti ve 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.
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3.4 External SpO2 Probe Connection
1. Connect the external SpO
2
probe to SpO2 sensor
connector in the following way. Make sure the side
with “Arrow” faces up wards.
Figure 6 Probe Connection
Note: wh en th e exter nal SpO2 probe i s conne cted we ll,
the built-in finger clip sensor will be disabled. The
measurement is detected from the external SpO2 probe.
2. The finger should be put in SpO2 probe properly and
correctly.
3. The oxi meter will power on aut omatically 2 s econds
later, then display softw a r e ve rsion num ber.
4. Other operation is similar to chapter 3.1 directly
measurement.
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4. Technical Specifications
A. Technique: dual-wavelength LED sensor,
LED sensor wavelength:
Red light: 663 nanomete rs,
Infrared light: 890 nanometers.
Maximal optical output power:
less than 1.5mW maximum average.
B. SpO
2
measurement
Measuring range: 70%~100%
Mea su ring ac curacy:
A
rms
is not greater than 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% (default 90%)
C. Pulse Ra te measurement
Measuring range: 30bpm~240bpm
Measuring accurac y: ±2bpm or ±2 % (whichever is
greater)
Pulse Rate limit setting range:
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high limit: 100~240bpm (def ault 120bpm)
low limit: 30~60bpm (default 50bpm)
D. Perfusion Index(PI) Display
Range: 0.2%~20%
E. Audible &visual over-limit indicatio n
Whe n measuring, 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.
F. Display mode
：
Color OLED Display
G. Po wer su pply requirem en t :
2 x LR03 (AAA) alkaline batte ries
Supply voltage: 3.0VDC
Operating cur r ent: ≤40mA
H. Environment requirement
Operating Temperature: 5 ~40°C
Operating Humidity: 30~80%
Atmospheric pressure: 70~106kPa
I. The perfo rmance under low p erfus ion condition
The accuracy of SpO
2
and PR measurement still
meets the specification described above when the
modulation amplitu de is as low as 0.6%.
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J. Resis tance 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%.
K. Dimensions:
60 mm (L) × 33 mm (W) × 30 mm (H)
Net W e ight: 35g (including battery)
L. 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
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5. Accessories
A. A lanyard
B. Two batteries
C. A pouch
D. An External SpO
2
Probe (optional)
E. A User Manual
F. Quality Certificate
Note: The accessories are subject to change. Detailed
items an d q uantity see the Packing List.
6. Repair and M a intenance
6.1 Oximeter Maintenance
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.
Please 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
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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, there is no need to calibrate it during its li fe
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.
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.
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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.
Can not 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. Cha nge
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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Appendix
A Key of Symbols
Symbol
Description
With Type BF applie d part
Warning ─ See User Manu al
%SpO2 The pulse oxyg e n satura t ion
PR Pulse rate (beats per minute)
Pulse rate icon
Low battery voltage
SN
Serial number
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B SpO2 Common Knowledge
1. Meaning of SpO
2
SpO2 is the saturation percent age of oxygen in the 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 respi rati on 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 ta nce is di re ctly p ropor ti ona l with its d ens ity 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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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 tre a tm en t has b ec ome more p opular. (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 car e
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 oxyhem oglobin variation
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
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