Creative PC-60NW User Manual

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User Manual for Fingertip Oximeter
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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.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Version of the Manu al: Ver 1.1 Revised date: July 19, 2012 All rights reserved .
3502-2290047
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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°, burn ing hu rt may occ ur 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 s hould not stare a t 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 finger directly into sensor. Avoid placi ng the d evice on th e sa me limb whi ch
is wrapped with a cuff for blood pressure measurement or during venous infusion.
Do not let anythin g block the emittin g light from
device.
Vigorous exercise and electrosurgical device
interference may affect the measuring accuracy.
The orientation-sensor works on the basis of the
gravit y. A small movab le metal ball is bu ilt in the orientation-sensor for det ecting the orienta tion of
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the oximeter. When you want to change the oximeter’s display direction, if you move the oximeter too slowly, the movable metal ball will also move slowly because of not enough acceleration. Consequently the response of orientation detection would be delayed. Please move the oxi meter with a bit of force i f you want to change the display direction (such as bend/extend your finger quickly), so an acceleration is provided to the orientation-sensor for quick sensing th e orientation change.
Using enamel or other makeup on the nail may
affect the accuracy of measurement, too long fingernail may casue failure of measurement or unaccuracy measurem ent 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 sunshire, etc. may cause unaccuracy 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
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unlikely true, the more stable value is expected by waiting for a while, or a restart is needed when necessary.
Note: Due to the working principle of or ient ation sensor used in oximeter, there is a small metal ball which is movable within its compartment of the orientation-sensor. Therefore you can hear a slight “clatt er” sound when you wave or shake the oxim eter. It is normal and not caused by unwanted part.
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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 D irec tly 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
3.5 Data transmission ............................................... 11
4. Techni c a l S p ecifications .......................................... 12
5. Accessories ............................................................... 15
6. Repair and Maint e nance ......................................... 15
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6.1 Oximeter Maint enan c e ....................................... 15
6.2 C leaning and Disi nfect ing Instru c tion .............. 17
7. Troubleshooting ....................................................... 18
Appendix ...................................................................... 20
A Key of Symbols ...................................................... 20
B SpO
2
Common Knowled ge ..................................... 21
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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 Conforma tion
It consists of main unit and photoelectric sensor, and additional data upload connector.
1.5 Features
Wireless data transmission can communicate with
PC/mobile phone/PDA.
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
Automatic change display direction
Automatic power on/off
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Audible & visible over-limit indication
Pulse beep with pitch tone, pulse beep on/off and
high & low limits can be set via setup menu.
Shift parame te r displ ay betwee n P R a n d P I
2AAA alkaline batteri es with low power consu mption
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 the batteries are correct ly 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.
Figure4A Figure4B
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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;
Wireless symbol
Change displ ay d irection:
Tilt the oximeter to change display direction. It is better for user to read value con veniently.
Shift parameter display between PR and PI during measurement:
Short time press Display Key to shift the 4A and 4B. When shown as 4B, the display will shift 4A automatically after 20 seconds without operation.
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Wireless icon“
The color of “
Definition
”displays gray " Wirel e ss" func tion is disabled
The device fails to setup a
wireless connection with the surrounding host.
flas 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.
No display“ ”icon
Hardware failure of wireless
transmission function.
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When the device fails to try establishing wireless connection within 3 minutes, the icon “
” will become gray and the "Wireless" function is disabled automatically. You have to enable it next time manually.
Notes: Notes: The pulse beep has the pitch-tone feature (when SpO2 value is higher than 90%), that means, the beeping to ne changes acc o rding to th e SpO2 value.
3.2 Over-limit indication and beep silence
When measuring, if SpO
2
value or pulse rate value exceeds the preset 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 followi ng situ ations:
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 sound automatically lat er 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
“Wireless”the wireless on-off button. Transmitting data to PC when it is on. “on” and “off” can be optional. The facto r y def a ul t i s “on”.
“SpO
2
alm Lo SpO2 low limit. 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
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default is 120. “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. Long time press Display Key to active the setting
item, then short time pres s it to modify the se tting parameter;
3. Next, long time press Dis play Key to con firm 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 well, 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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3.5 Data transmission
This oximeter has the function of wireless data transmission. The user could effectively transmit the data to computer through the wireless communication module. Refer to the Oximeter Data Managerfor detai led information.
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4. Technical Specifications
A. Technique: dual-wavele ngth 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%
Note: 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 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 (def ault 120bpm)
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low limit: 30~60bpm (default 50bpm)
D. Perfusion Index(PI) Display
Range: 0.2%~20%
E. Audible &visual over-lim it in dicatio n 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.
F. Display mode
Color OLED Display
G. Power supply requirement:
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 performance under low perfus 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. 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%.
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: Gro u p 1, Class B
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5. Accessories
A. A lan yard B. Two batteries C. A pouc h D. An External SpO
2
Probe (optional) E. A User Manu al F. Quality Certificate G. Installation CD (optional)
Note: The accessories are subject to change. Detailed items and quantity 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 chan ge th e batteries wh en 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.
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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, there is no need to calibrate it du ring 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.
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 devi ce in liquid.
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6.2 Cleaning an d Disinfec ting Instruct ion
Surface-clean sensor with a soft cloth by wet ting
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
Display direction doesn’t change or changes insensitively.
Maybe the oximeter is not used for a long time, the movable metal ball within the orientation-sensor can not move freely.
Please shake the oximeter with a certain force to make the movable metal ball move freely. If the pr o bl e m still exists, maybe the orientation-sensor is not working properly. Please contact the local service cent er.
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.
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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. 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.
No display of the wireless
icon
Hardware failure of wireless transmission function.
Please contact the local service center.
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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
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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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 ski n 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 lAbnormal oxyhemoglobin va riationMethemoglobin 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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