Creative PC-68B User Manual

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User Manual for Wrist Oximeter
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Instructions to User
PC-68B Wrist Oximeter is a precision measuring device, please read the manual very carefully before using this device. Failure to follow these instructions may cause measur ing abnormality or damage to the oximeter.
Version of This Manual: Ver 1.4 Revised date: July 26, 2012 All rights reser ved.
3502-2290033
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User Manual for Wrist Oximeter
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Notes:
The contents contained in this manual are subject to
change without prior notice.
Information furnished by Creative is believed to be
accurate and reliable. However, no responsibility is assumed by us for its use, or any infringements of patents or other rights of third parties that may result from its use.
Instructions for Safe Operations
Check the device to make sure that there is no
visible damage that may affect user’s safety and measurement performance. When there is obvious damage, stop using the device.
Necessary servicing must be performed by
qualified service engineers ONLY. Users are not permitted to mainta in it by themselves.
The oximeter cannot be used together with the
devi c es not s pecified in U ser M anual .
Cautions
Explosive hazard—DO NOT use the oximeter in
environment with inflammable gas such as some ignitable anesthetic agents.
DO NOT u se th e oximeter while the testee is under
MRI or CT scanning.
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Warnings
For individual patients, there should be a more
prudent inspecting in the placing process. The device can not be clipped on the edema and tender tissue.
The light (the infrared light is invisible) emitted
fr o m the se nso r is harmful to the eyes, so t he user or even the service engineer should not stare at the ligh t emitting comp onents.
To dispose the device, the local law should be
followed.
Attentions
Keep the oximeter away from dust, vibration,
corrosive substances, explosive materials, high temperature and moisture.
The device should be kept out of the reach of
children.
If the oximeter gets wet, please stop operating it.
When it is carried from cold environment to warm and humid environment, please do not use it immediately.
DO NOT operate the button on front panel with
sharp materials.
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High temperature or high pressure steam
disinfection to the oximeter is not permitted. Refer to related chapter for instructions of cleaning and disinfection.
Declaration of Conformity:
The manufacturer hereby declares that this device complies with the following standards:
IEC 6060 1-1 ISO 9919 and follows the provisions of the council directive
MDD93/42/EEC.
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User Manual for Wrist Oximeter
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Table of Contents
1 OVERVIEW .................................................................. 1
1.1 Appe aran ce .............................................................. 1
1.2 N a me and Mod el ...................................................... 2
1.3 Conformation ........................................................... 3
1.4 Fe at ures .................................................................... 3
1.5 Intended Use ............................................................ 4
1.6 Key of Sy mb ols ........................................................ 5
2 BAT TERY INSTALLATION........................................ 6
3 OPERATION ................................................................. 7
3.1 M e a su r ing Operat io n .............................................. 7
3.2 M e nu O pe ratio n .................................................... 15
3.3 Upload Data ........................................................... 21
3.4 Low Battery Indication ......................................... 22
4 ADDITIONAL ADV ICE FO R OPERATION............ 23
5 TECHNICAL SPECIFICATIONS ............................. 24
6 ACCESSORIES ........................................................... 27
7 REP AIR AND MAINTENANCE ............................... 28
7.1 Maintenance ........................................................... 28
7.2 C leaning and Di si nfect ing Instruction.................. 29
8 TROUBLESH OOTING .............................................. 30
9 APPENDIX .................................................................. 32
A Common Knowle dge for SpO
2
Measurement ........ 32
B Wrist band Installatio n and D i sasse mbly ................ 36
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1 Overview
1.1 Appearance
Figure 1 Front Vie w
1. LCD sc reen
2. Set key: shift display modes, confirm the
oper a tion etc.
3. Scroll key: short press: move display cursor, modify
parameter valu es et c.
Longtime press: choose display always on or not which will be eff ective during measuring.
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Figure 2 Frontal Side View
4. Buzzer
5. Dat a in terf ac e
6. Wristband Underlay
Figure 3 Right Side View
7. SpO2 pro be receptacl e
1.2 Name and Model
Name: Wrist Oximeter Model: PC-68B
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1.3 Conformation
It compr ises the main unit and SpO2 probe.
1.4 Features
Wrist Oximeter can be used to monitor pulse oxygen saturation (SpO
2
) and pulse rate accurately. Simply put
your finger into sensor, SpO
2
value and pulse rate value
will be displayed on screen and stored in the device.
It is lightweight, small in size and easy to carry; Color OLED display; Perfusion ind ex (PI) display is available;  Automatic starts to measure SpO
2
and Pulse
Rate(PR);
Real-time clock display and set; Audible & visible over-limit indication, high & low
limits are adjust able;
It is convenient for you to monitor SpO
2
in long-term
while sleeping or at other daily activity.
Rec ord in t erval can b e s e lected, up t o 48 0 hours d ata
memory;
Applicable for longtime continuous monitoring;
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PR trend curve and SpO2 trend curve view;  Data storage and transmission to PC for view and
analysis(Optional);
Smart battery power management with low battery
indication;
1. 5 Inte nded Use
This Wrist Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO
2
). It is
appli cable for long-ter m measu rement of adult’s SpO
2
and
pulse rate in home and clinics.
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1.6 Key of Symbols
Symbol
Description
%SpO
Pulse Oxygen Saturation
PI%
Perfu sion Index
PR
Pulse Rate
Pulse rate symbol
Low battery voltage
Symbol for display always on
Memor y full.
Seria l number
Date of manufacture
Aut ho rised representat ive in t he Europe an community
Manu facturer (including address) Wit h Type BF applied part
Warning
See User Manual
Disposal of this device according to
WEEE regu lations
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2 Battery Installation
Figu re 4 Batt ery Installation
1. Lift up the cloth covered on the battery cover. Then, use
your index finger and midd le finger t o press against the battery cover. Meanwhile, slide it towards the side with SpO
2
probe (as shown in Figure 4).
2. Refer to Fi gure 4, insert t wo AAA size batte ries int o the
battery compartment properly in the right direction.
3. Replace the cover. Remark: After finishing battery installation, the oximeter
will automatically power on and display software version number firstly.
Please take care when you insert the batteries, as the
improper insertion may make the device not work.
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3 Operation
3.1 Measuring Operat ion
1. Insert the external SpO2 probe connector into SpO2 probe rece ptacl e properly.
Figu re 5 Sp02 Probe Connection
2. Fix the oximete r on your left wrist (Figure 6);
3. Then, hold the probe with its opening towards your index finger. The probe should be oriented in such a way that the sensor side with a finger tip sign is positioned on the top (Figure 6).
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Figure 6 Placement Demonstration
4. Next, insert your index finger into the probe until the fingernail tip rests against the stop at the end of the probe (Figure 7). Adjust the finger to be placed evenly on the middle base of the sensor (make sure the finger is in the right position). If the index finger cannot be positioned correctly, or is not available, other finger can be used.
Figure 7
Finger tip sign
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Wrong Placement of the Probe:
Figure 8
5. The oximeter will automatically start measurement in 2 seconds. Then the defau lt screen will be disp layed (Fi gure 9A). User can read the valu es and view the waveform from the display screen.
Figure 9 A Defau lt Screen
“%SpO
2
”: SpO2 symbol; “99”: SpO2 value;
“PR”: Pulse rate icon; “65”: Pulse rate value;
”: Pulse beat sym bo l;
”: Batte ry indicator;
”: Puls e intensity bargraph.
The waveform displayed in the lower area is SpO
2
plethysmogram.
Finger out Not deep enough
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Key Operations:
Short time press
” key to switch display modes
circularly, dis pla y screen will be switched am ong the screens as shown in Figure 9A, Figure 9C and Figure 9D.
Longtime press “
” key: choose display always on
or not which will be effective during measuring. If you choose display always on, the symbol for “display always on” will appear on the screen as shown in Figur e 9B.
Short time press “
” key, the display screen can
shif t 180
Figure 9B
”: Symbol for dis play always on, it indicat es that
the LCD screen is always on during meas urin g. If the symbol is disappeared, it indicates that the LCD screen will be off after a period of display time during measuring for power saving.
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Figure 9C
“PI%”: Perfusion index symbol;
Figure 9D Real Time Clock
“12:30”: the current time;
Key Operations:
Longtime press “
” key, menu screen will be
disp layed, refer to section 3.2 for details;
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6. Prompt information
During monitoring, if you haven’t inserted your
finge r into th e probe, “Finger out ” will b e p romp ted on the screen.
During monitoring, if the probe is not connected to
the oxi met er or the pr ob e is off, “No Si gn a l!” will b e promp ted on the screen, as shown in Figur e 10.
Figure 10 No Signal
During measuring, if the memory is full or the total
number of the records is 1024 pieces, the earliest records will be overwritten and the icon “ ” will appear on the screen for prompt, as shown in Figure
11.
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Figure 11 Memo r y Full
Note: It is suggested that the data shall be uploaded
to compu ter for saving, or the ear liest records will b e overwritten.
W orking Mode
The measurement will start automatically when the
finger is inserted into the soft rubber of the se nsor, so the data recording (SpO
2
and PR values) starts simultaneously as well. The display is as shown in Figure 9A
During measuring, if the display mod e is n ot display
always on (the symbol for “display always on” i s n ot shown on s creen) and no key button operation for 1 minute, the LCD display will be blank for power saving even when the measurement and data recording are still undergoin g, but long time pressing
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any key will activate the display for viewing the current measuring information again.
If there is no signal to be detected (e.g. finger off) for
20 seconds, th e device wi ll be at idle state (i.e. blank scr een and standby for measurement).
When the device is at idle state, long time pressing
any key will act ivate th e LCD display for measuring default screen, or once the finger is inserted in the soft rubber of the sensor, the measurement will s tart and LCD dis play will be activated as well.
Note: During measuring, there is a green-dot flashing on the screen for indicating the measurement and data recording are undergoing when the display screen is blank, and if SpO2 or/and PR values exceed the preset limit, it will active the display and the value exceeded limit will flas h.
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3.2 Menu Operation
On display screen, longtime press “” key menu screen wil l be displayed on the sc reen, as shown in Fig ure 12.
Figure 12 Menu Screen
Rec Interval: set the interval to record SpO
2
and
pul se r ate da ta;
Alarm: set SpO
2
low limit and puls e rate high/low
limit;
Time: set current time;  Trend Review: view SpO
2
and pulse rate trend
graph ;
Delete Data: delete all the records.
Operation In st r uctions:
Short time press “
” key: shif t cursor circ ul a r l y;
Short time press “
” key: confirm the selection
and ent er into the corresponding screen;
Longtime press
” key: back to the default
screen;
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3.2. 1 Record Interval Setting s
On menu screen, select “Rec Interval” and press “
” key
to enter Record Interval Setting screen, as shown in Figure
13.
Figu re 13 Record Int erv al Sett in g
Operation In st r uctions:
Short time press “
” key: active the option;
Short time press “
” key: select record interval;
three options: “1s”, “4s” and “8s;
Short time press “
” key: confirm the sele ction;
Longtime press
” key: back to the menu screen;
Note: The len gth of data record is limited to 30 seconds at least, and the maximal length for one record is also limited to 60 hours (for 1 second interval) , 240 hours (for 4 second interval) or 480 hours (for 8 second interval).
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3.2. 2 O v e r-li mi t indication Settings
On m enu screen, select “Alarm Limit” and p ress “
” key
to enter Alarm Limit Settings screen, as shown in Figure
14.
Figu re 14 Over-l i mit indic ation Settings
SpO
2
Lo: set SpO2 low limit; Setting
range:85%~95%, default setting: 85%;
PR Lo: set pulse rate low limit; Setting
ran ge:25bpm~99bpm , de fault sett ing: 50bpm;
PR Hi: set pulse rate high limit; Setting range:
100bpm~250bpm, default setting: 120bpm;
Alarm: enable/disable the audible & visual limit
indication function.
If SpO
2
value or/and PR value exceeds its/their preset limits during measuring, the oximeter will beep and the numerical value exceeded limit will flash. Pressing “
key can suspend the cur rent beep sound.
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Operation In st r uctions:
Short time press “
” key: shif t cursor circ ul a r l y;
Short time press “
” key: active the option;
Short time press “
” key: increase numerical value
one time;
Long tim e press
” key: increase numerical values
continuously;
Short time press “
■” key: confirm the sele ction;
Longtime press “
” key: back to the menu screen;
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3.2. 3 T im e Sett in gs
On menu screen, select “Time” and press “
” key to ente r
Time Settings screen, as shown in Figure 15.
Figu re 15 Time Settings
Date format: MM/DD/YYYY; Time format: hh:mm:ss;
Operation In st r uctions:
Short time press “
” key: shif t cursor circ ul a r l y;
Short time press “
” key: active the option;
Short time press “
” key: increase numerical value
one time;
Longtime press “
” key: increase numerical value
continuously;
Short time press “
” key: confirm the modification;
Longtime press
” key: back to the menu screen;
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3.2.4 Trend Review
On menu screen, sele ct “Trend Review” and press “
” key
to enter Trend Review screen, as shown in Figure 1 6.
Figu re 16 Trend Re view Screen
“03/06/2008”: date of th e measurement “11:20:35”: initial time of trend graph displayed
on th i s sc reen;
”: Page scroll (left/ right) symbol;
Cur v es in the mid d le area:
Green curve: indicate pulse ra t e tr end curve; Orange curve: indicate SpO
2
trend curve;
Operation In st r uctions:
Short time press “
” key: Page scroll right;
Short time press “
” key: Page scroll left;
Longtime press
” key: back to the menu screen;
Note: when the display screen is menu screen or its submenu screen , the mea sur em ent will be interrupt ed.
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3.2.5 Delete Data
On menu screen, select “Delete Data” and press “” key to enter into Deletion Confirmation screen. Then, select “Yes” with “” key(short time press), after short time pressing “” key, all the records will be deleted.
Figu re 17 Delete Recor ds
3.3 Upload Data
Before uploading the data to PC, p lease quit from the menu screen if you are doing the setup or trend view operation. When start uploading, connect the data cable between the device and PC, do the following operation by the instruction in “Oximeter Data Manager User Manual”, then the data uploadi ng will be activated.
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3.4 Low Battery Indication
If “ ” occurs on the screen, it indicates ba tter y power is not enough, please change batteries. If you keep on using, after a while, when the batteries are exhausted, “Low Battery!” indication will be displayed and the oxime ter will be off in 5 seconds.
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4 Additional Advice for Operation
The finge r should be put properly and correctly. Avoid shaking finger as possible as you can during
measuring;
Do not put wet finger directly into sensor. Avoid placing the de vice on the same limb whic h is
wrapp ed with a cuff for blood pressure measur ement or during venous infusion.
Do not let anything block the emitting light from
device.
Electrosurgical device interference may affect the
measuring accuracy.
Using enamel or other makeup on the nai l may affect
the measuring accuracy.
If the first reading appears with poor waveform
(irregular or n ot 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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5 Technical Specifications
A. Di splay mode Color OLED Display B. Power supply requirement:
2 x LR03 (AAA) alkaline batteries or Ni-MH rechargeable batteries
Supply voltage: 3.0VDC
Continues workin g time (display is off): 70hours
C. Operating curren t: 40mA D. SpO
2
Parameter Specifications
T ransducer: dual-wavelength LED Measur ement wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maxi mal optical outpu t power: less than 1.5mW maxi mum average Measuring range: 35~100% Measur ing accuracy: Not gre ater than 3% for SpO
2
range from 70% to 100%
*NOTE: A
rms
is defined as root-mean-square value of
deviation according to ISO 9919.
E. Pu lse Rate P arameter Speci f icatio n s
Measuring range: 30bpm~240bpm Accuracy: ±2bpm or ±2% (whiche ver is greater)
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F. Preset limit s:
SpO
2
Low limit setting: 85%
Pulse Rate limit setting range:
Upper limit: 120bpm Lower limit: 50bpm
G. Update rate:
6 sec onds moving average for SpO
2
an d 8 beats
average for Pulse Rate readings.
H. Perfusion Index Display
Range: 0.2%~20%
I. Performanc e u n der low perfusion con dition
The accuracy of SpO
2
and PR measurement still meets the specification described above when the modula tion amplitu de is as low as 0.6%.
J. Resistance to interference o f su r rounding light:
The difference between the SpO
2
value measured in the condition of indoor natural light and that of dar kroom is less than ±1%.
K. Resistance to 5 0Hz /60Hz interference:
SpO
2
and PR are precise which have been tested by
BIO-TEK pulse oximeter simulator.
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L. Dimensions: W 59mm×D 49mm×H 22mm Net W eight: about 60g (not includi ng batteries) M. Classification
The type of protection against electric shock:
Internally p owered equipment.
The degree of protection against electric shock:
Type B F applied part.
The degree of protection against harmful ingress of liquids: Ordinary equipment without protection against ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
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6 Accessories
A data cable (optional) Oximeter Dat a Manager software (optional) A Wristband A SpO
2
Probe
Two batteries (AAA) A User Manua lQuality Certificate
Note: The accessories are subject to change. See the Packing List for detailed items and quantity.
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7 Repair and Maintenance
7.1 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 th e maintenance.
Please change the batteries when the low-voltage
indicator lightens.
Please clean the surface of the device before using.
Use cloth with alcohol to wipe the device first, and then let it dry 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 per atur e: -20ºC ~60ºC, relative humidity 10%~95%, atmospheric pressure: 50kPa~107.4kPa.
The oximeter is calibrated in the factory before sale,
there is no need to calibrate it during its life cycle. However, if it is necessary to verify its accuracy routinely, the user can do the verification by means of SpO
2
simulator, or it can be done by the local third
party test house.
High-pressure sterilization cannot be used on the
device.
Do n ot immerse the device in liquid.
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7.2 Cl eaning a nd Dis infecting Instruc tio n
Surface-clean sensor with a soft gauze 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 with a damp cloth and dry with a piece of cloth.
Clean the wristband with soap y water. Pleas e detach
the wristband from the oximeter firstly.(Refer to Appendix for detailed disassembly method)
Caution: Do n ot ste rilize b y irr adiati on ste am, or ethylen e
oxide. Do not use the sensor if it is damaged.
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8 Troubleshooting
Trouble
Possi ble Reason
Solution
The SpO
2
and Pulse Rate display
instable
1. The finger is
not
placed far enough inside.
1. Place the finger corre ctly inside
and
try again.
Can not turn on the device
1. T
he batteries are
drained or almost drained.
2. T
he batteries are
not ins erted properly.
3. The device is malfunctioning.
1. Change batte r i e s .
2. Reinstall batteries.
3. Please contac t the
local s ervice center.
Fragmental trend curve of SpO
2
and PR
1. Your finger is out of pr oper lo ca tion in the probe.
2. Blood flow in the finger blocked.
3.
Extreme
movement
1. Adjust your finger
location properly.
2. Make
sure there is
no obj ect may occlude the blood flow.
3. Extreme movemen t may caus e invalid
measur ing result.
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Trouble Possi ble Reason Solution
Always display “No Signal”
1. T he probe is no t
connected to the oximeter properly.
2. The finger is
not
placed well.
3. The probe connector or the prob e sensor is broken.
1. Connect the
probe to the oximeter properly and tr y again.;
2. Place the finger prope rly and try again.
3. Please contac t the local service
center.
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9 Appendix
A Common Kn o wledge for SpO2 Measurement
1 Meaning of SpO
2
SpO2 is the saturation percentage of oxygen in the blood, so called O
2
concent rati on in th e blood; it is defined by the
percentage of oxyhemoglobin (HbO
2
) in the total
hemoglobin of the arterial blood. SpO
2
is an important physiological parameter to reflect the respiration function; it is calculated by the following method:
SpO
2
= HbO2/ (HbO2 +Hb)×100%
HbO
2
are the oxyhemoglobins (oxygenized hemoglobin),
Hb are those hemoglobins which release oxygen.
2 Principle of Measurement
Based on Lamb er-Beer law, the light absorbance of a given substance is directly proportional with its density or concentration. When the light with certain wavelength emits on human tissue, the measured intensity of li gh t a ft er absorption, reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light
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passes. Due to that oxygenated hemoglobin (HbO2) 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 per centa ge of th e hem oglobi n that can transp ort oxygen . In contrast, hemoxi meters report fractional oxygen saturation – a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin.
Clinical application of pulse oximeters: SpO2 is an important physiological parameter to reflect the r espirati on and ventilation function, so SpO
2
monitoring used in clinical becomes more popularly, such as monitoring the patient with serious respiratory disease, the patient under anesthesia during operation, premature and neonate. The status of SpO
2
can be determined in time by measurement and find the hypoxemia patient earlier, thereby preventing or reduc ing accidental death caused by hypoxia effectively.
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3 Factors affecting SpO2 measuring accuracy (interference reason)
Intravascular dyes such as indocyanine green or
met hylene 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 Placement of a sensor on an extremity with a blood
press ure cuff, arte rial catheter, or intr avascular line
Exposu r e to the chamber with High pressure oxygen There i s an ar te rial occ lusion pr o x imal 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 (pa thology reason)
Hypoxemia disease, functional lack of HbO
2
Pigmentation or abnormal oxyhemoglobin levelAbnormal oxyhemoglobin variationMethemoglobin disease Sulfhemoglobinemia or arteria l occlusion ex ists near
sensor
Obvious veno us pulsatio ns Peripheral arter ial pul sa tio n beco mes weak Peripheral blood supply is not enough
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B Wristband Installation and Disassembly
Step 1: Fi x the wristband on your left wrist(Fig.A).
Step 2: Put the oximeter on the propriate site of the
wristband. Then press the oximeter to ma ke the wristb and underlay(Fig.B) st ick to t he wri stband firmly. Ne xt, follow the Fi g.C to fix the oxim eter well.
St e p 3: The process of wristband disassembly is similar to the installation method, but with reverse procedure.
Note: Please detach the wristband from the
oximeter before cleaning the wristband.
Wristband
underlay
Fig. A
Fig.C
Fig . B
Wristband
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