Creative PC 66B User Manual

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User Manual for Handheld Pulse Oximeter
I
Instructions to User
Dear Customer, Thank you for purchasing this quality product. Please read the
manual very carefully before using this device. Failure to follow these instructions can cause measuring abnormality or damage to the Oximeter.
No part of this manual may be photocopied, reproduced or translated into another language without the prior written consent. We reserve the right to revise and amend it at any time without prior notice.
Version of the Manual: Ver 1.2 Issued Date: September 29, 2014
All rights reserved.
Notes:
z
The contents contained in this manual are subject to change without prior notice.
z
Information furnished by Creative is believed to be accurate and reliable. However, no responsibility is assumed by Creative for its use, or any infringements of patents or other rights of third parties that may result from its use.
3502-2490003
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Instructions for Safe Operation
0
Check the device to make sure that there is no visible
damage that may affect user’s safety and measurement performance. It is recommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device.
0 Necessary service must be performed only by qualified
technicians. Users are not permitted to service this device.
0
The oximeter must not be used with the devices and
accessories not specified in User Manual.
Cautions
0 Explosive hazard—DO NOT use the oximeter in
environment with inflammable gas such as some ignitable anesthetic agents.
0
DO NOT use the oximete
r
while the Patient is unde
r
MRI o
r
CT scanning.ThisdeviceisNOTMRI
Compatible.
Warnings
0
Discomfortable or pain may occur if using the sensor of
this device continuously on the same location for a long time, especially for the patients with poor microcirculation. It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours or less if any abnormal condition is found. Frequently check and re-position the Oximeter.
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III
0
For the individual patients, there should be a more
prudent inspecting in the placing process. The sensor can not be placed on the edema and tender tissue.
0
The local law should be followed when disposing of the
expired device or its accessories.
Attentions
Keep the oximeter a way from dust, vibration, corrosive
substances, explosive materials, high temperature and moisture.
If the Oximeter gets wet, please stop operating it and do
not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for the Oximeter to reach ambient temperature.
DO NOT operate the button on the front panel with sharp
materials or sharp point.
DO NOT use high temperature or high pressure steam
disinfection on the oximeter and probes. Refer to related chapter for instructions regarding cleaning and disinfection.
The intended use of this device is not for therapy purpose.
Declaration of Conformity
The manufacture
r
herebydeclares that this device complies
with the following standards:
IEC 60601-1, ISO 9919:2009,ISO 80601-2-61:2011
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and follows the provisions of the council directive MDD93/42/EEC.
Caution: U.S. federal law restricts this device to sale or use by or on the order of a physician.
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Table of Contents
1 Overview.................................................................................. 1
1.1 Appearance....................................................................... 1
1.2 Product Name and Model.................................................. 2
1.3 Structure............................................................................ 3
1.4 Features............................................................................. 3
1.5 Intended Use..................................................................... 3
1.6 Working Environment....................................................... 3
2 Installation of Battery and Holder........................................ 4
3 SpO
2
Probe Connection.......................................................... 6
4 Operation................................................................................ 8
4.1 Power on/off the Oximeter................................................ 8
4.2 Default Display Screen..................................................... 8
4.3 Display Screen with PI Value......................................... 10
4.4 Menu Setup..................................................................... 10
4.5 Data Recall...................................................................... 16
5 Technical Specifications....................................................... 20
6 Over-limit Indication............................................................ 22
6.1 Limit settings.................................................................. 22
6.2 Alert sound mute setting................................................. 22
7 Accessories............................................................................. 23
8 Repair and Maintenance...................................................... 24
8.1 Maintenance.................................................................... 24
8.2 Cleaning and Disinfecting Instruction.............................24
9 Troubleshooting.................................................................... 25
Appendix.................................................................................. 26
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1 Overview
1.1Appearance
Figure 1-1
1. Display screen: display SpO
2
plethysmogram and parameter
values.
2. Navigation key: ¿ : Up/Left/Increase
Data interface
Display Key
Navigation knob
DC power input
Power/Back
Recall/Mute
SpO2probe connector
Mode/OK
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Press this key, the default screen can be shifted to display pulse rate (PR) or perfusion index (PI). If on the system setup screen, press it to move the cursor upwards or to the left and adjust parameter values.
À : Down/Right/Decrease
Its function is similar with the key “¿ : Up/Left/Increase”.
3.
(Mode/OK): press this key, the screen can be shifted
between default screen display and alternative screen display; longtime press it, the menu screen will be displayed; when you finish parameter setting, press this key to confirm.
4.
(Data interface): used for uploading data (Optional
function).
5.
(DC power input): used for connecting external DC
power input for recharging the built-in rechargeable battery.
6.
(Power/Back): Power on/off the device by longtime
pressing; short time press it to back to the previous level of menu while setting menu operation.
7.
(Recall/Mute): Longtime press it to enter SpO2trend data
recall screen; when the device is beeping, short time pressing will mute the indication sound, the mute state will persist for about 90s. After this mute period (90s), then the indication sound will resume.
8. Icon: “SpO2”:SpO2Probe Connector.
1.2 Product Name and Model
Name: Handheld Pulse Oximeter
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Model: PC-66B
1.3 Structure
It consists of the main unit and SpO2probe.
1.4 Features
It is lightweight, small in size and easy to carry
Color LCD to display plethysmogram and parameters
Monitor SpO2and Pulse Rate simultaneously
PI (Perfusion Index) display is available
Up to 384 hours storage and recall of SpO2and PR data.
Audible and visual alert function is available
Data transmission to PC for view and analysis (Optional)
Power saving mode is available
1.5 Intended Use
This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate and functional oxygen saturation (SpO
2
).
It is applicable for monitoring SpO
2
and pulse rate of adult and
pediatric patients in clinical institutions and homes.
1.6 Working Environment
Operating temperature: 5~40
Operating humidity: 30~80% Atmospheric
p
ressure: 70kPa~106kPa
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2 Installation of Battery and Holder
1Open the rear panel with coin or an ordinary flat
screwdriver, as shown in Figure 2-1.
Figure 2-1
2)AAAlkaline batteries or Lithium battery (optional):
If AA alkaline batteries (non-chargeable) are provided, then
according to the polarity mark, insert three AA batteries into battery house, as shown in Figure 2-2.
Figure 2-2 Figure 2-3 Fixing Holder
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If Lithium battery (rechargeable) is provided, place t he
lithium battery into the battery house, and insert its terminal header into the corresponding connector in the
battery compartment. 3)Close the battery cover and lock it. 4)Fixing Holder, as shown in figure 2-3. Notes:
When the device is provided with AA alkaline batteries and it shows low battery, the user should replace the batteries in time.
When the device is provided with lithium battery and it shows low battery, the user should recharge the battery in time. That is, connect one end of the charging cable to the device's DC power input, and connect the other end to the USB power (from PC or DC adapter). When the display screen appears the rolling icon "
", it means the battery is charging; When the
screen shows icon "
", it means the battery is fully charged. Pulling out the charging cable, then the above icon will disappear.
Safety instruction for operation:
0
Do not throw the battery into the water, liquid and fire.
0
Keep the battery out of the reach of the child.
0
Do not disassemble the battery.
Please remove the battery and put it to specified condition if
the device will not be used for a long time.
If the battery is damaged, please replace it with the same
model AA alkaline battery or lithium battery provided by the same manufacturer.
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In order to prolong the lithium battery's using life, please pay
attention to the battery maintenance.
3 SpO2Probe Connection
Connect the SpO2probe to the connector labeled “SpO2”atthe right side of the Oximeter. After starting up the Oximeter, insert one finger (index finger, middle finger or ring finger with proper nail length) into the probe according to the demonstration shown in the following figure.
Figure 3-1 Demonstration for Using SpO2probe (finger clip)
Instructions of Operation
1. The finger should be put in properly and correctly.
2. Do not shake the finger and keep at ease during measurement.
3. Do not put wet finger directly into sensor.
4. Avoid placing the sensor on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion.
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5. Do not let anything block the emitting light from the sensor.
6. Vigorous exercise and electrosurgical device interference may affect the measuring accuracy.
7. Using enamel or other makeup on the nail may affect the measuring accuracy.
8. 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 re-inserting finger is needed when necessary.
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4Operation
4.1 Power on/off the Oximeter
¾
When the device is off, press
power/back key
for 2 seconds to power up the Oximeter, then it will enter into measurement display screen.
¾ If the Oximeter is working, longtime press
power/back key
to power it off.
¾
During measurement, if the "probe off" is detected for longer than one minute, then the device will power off automatically.
¾ If not in the measurement state and there is no
any key operation for 1 minute, the device will power off automatically as well.
4.2 Default Display Screen
Press
power key for 2 seconds to start up the Oximeter, then insert the finger into the rubber cushions of the probe, the screen will display the default screen, as shown in Figure 4-1.
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Figure 4-1 Default Screen
Description:
”: Memory full icon; if the memory is full, the memory
full icon "
" appears on the screen. No display of this icon means the current storing space is not full. If the memory is full, the data storing will continue in such way the new record will overwrite the oldest record, so that it's recommended to upload the stored data into the computer in time.
During the measurement, short time press recall/mute "
" key to turn off (or resume) the pulse beep sound, while the pulse symbol "
" still blinks. For alert sound mute function,
refer to Section 6.2 for detail. Note: The pitch tone of pulse beep (dididi...) is modulated by
the SpO
2
value, that means the pitch tone changes when the
measured SpO2changes. The higher the SpO2value is, the
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higher the tone frequency of pulse beep (sound becomes sharper); The lower the SpO2value is, the lower the tone frequency of pulse beep (sound becomes flatter).
4.3 Display Screen with PI Value
On the default display screen, press “¿ /À ” Navigation key to shift screens between default screen and display screen with PI value. The display screen with PI value is shown below.
Figure 4-2 Display Screen with PI Value
4.4 Menu Setup
On the above mentioned screens, longtime press “ ”keyfor entering into setup menu screen (as shown in Figure 4-3).
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Figure 4-3 Setup Menu Screen
Screen Description
¾ “Setting”: set parameter values, refer to Chapter 4.4.1 for
details.
¾
“Upload data”: enter into data uploading state, refer to Chapter 4.4.2 for details.
¾
"Default": enter into the factory default setting, refer to Chapter 4.4.3 for details.
¾
"
简体中文
": this Oximeter provides the display with two
languages: English and "
简体中文"(
Simplified Chinese).
¾
“Version”: for viewing version number of the software, refer to Chapter 4.4.5 for details.
4.4.1 Setting
On the menu screen, select “Setting” and then press “
”key for entering into system setup screen. The setup screen is as shown in the following figures.
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Figure 4-4 System Setup Screen
Operation Instructions:
¾
Patient: according to the type of SpO
2
probe, the matched patient type should be selected, there are two options:"ADU " for adult, and "NEO " for neonate.
¾
SpO
2
Lo-Limit: SpO2low limit setting; range: 50%~99%,
the step is 1%. The factory default value for adult is 90% and 85% for neonate.
¾
PR Hi-Limit: High limit setting of pulse rate; range: 100~240bpm. From 100 to 150, the step is 1bpm, and from 150 to 240, the step is 5bpm. The factory default value for adult is 120bpm and 160bpm for neonate.
¾ PR Lo-Limit: Low limit setting of pulse rate; range:
30~99bpm, and the step is 1bpm. The factory default
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value for adult is 50bpm and 60bpm for neonate.
¾
Date: Date setting
1When cursor stays on the Year of the date, press “
(Mode/OK) key to active Year option, the cursor flashes on the Year of the date;
2Press ¿/À (Navigation key) to adjust year. 3Press “ ” (Power/back) key or “ ” (Mode/OK) key to
confirm and exit from date setting.
4The procedures of adjusting Month value and Day value
are the same with Year adjustment.
Date Format: yy-mm-dd
Note: T he setting operations of other parameters (such as TIME, PATIENT, RECORDING INTERVAL, POWER SAVING etc.) are the same with date setting.
¾
Time: Time setting
¾
Recording: Time interval for recording data (SpO
2
&
PR), there are five options: “1s, 2s, 4s, 8s” and “OFF”.
1) "1s": the least length of data record is set to 30 seconds, and the maximal length for one record is limited to 1 hour. The total storage time is up to 48 hours.
2) "2s": the least length of data record is set to 60 seconds, and the maximal length for one record is limited to 2 hours. The total storage time is up to 96 hours.
3) "4s": the least length of data record is set to 120 seconds,
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and the maximal l ength for one record is limited to 4 hours. The total storage time is up to 192 hours.
4) "8s": the least length of data record is set to 240 seconds, and the maximal l ength for one record is limited to 8 hours. The total storage time is up to 384 hours.
5) When the option i s set to “OFF”, the device will not store the
measuring data.
¾
Power saving: power saving setting; two options: "on" and "off". The factory default setting is "on". If the power saving mode is on during measurement, and there is no key operation for 2 minutes, the screen display will be dim for power saving. The display brightness will resume to normal condition by pressing any key.
¾
Volume (optional): 3 levels setting: "1", "2" and "3", corresponding to the speaker volume icons of "
", " "
and " " respectively. The speaker volume icon indicates
the volume of any sound generated by the device for key clicks, over-limit alerting, pulse beep and audible probe-off indication etc..
4.4.2 Upload Data
On the menu screen, select “UPLOAD DATA” and then press “
” key for entering into connecting status (as shown in Figure 4-5). Note: Make sure the provided USB data cable is well connected between the device and PC before uploading data.
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When you transmit data (SpO
2
and PR values) to your computer, please let the oximeter stay in connecting status. Do the following operation by the instruction in “Oximeter Data Manager User Manual”. The data uploading will be activated.
Figure 4-5 Connecting Status Screen
4.4.3 Default
On the menu screen, select "Default " and then short time press "
"key for entering into default setting screen (as shown in
Figure 4-6). Press the Navigation "
" key to choose "Yes"
or "No", and press "
" mode/OK key to confirm or exit. Short
time press "
" power/back key to return to the previous menu
screen.
Figure 4-6 Default Setting Screen
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4.4.4 Language Selection
¾
In Simplified Chinese version: on main menu screen, select "English" and then short time press " "key,the display language changes to English.
¾
In English version: on main menu screen, select "Simplified Chinese" and then short time press "
"key,
the display language changes to Simplified Chinese.
4.4.5 Version
On the menu screen, select “VERSION” and then press “
key for entering into version screen (as shown in Figure 4-7).
Figure 4-7
4.5 Data Recall
On the default di spl ay screen, longtime press “ ” ( Recall/mute) key to enter into record list display screen.
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Figure 4-8 Record List
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4.5.1 Data Recall
Choose record in the record list, then press “ ”(mode/OK) key, the display screen will display trend graph, as shown in Figure 4-9A.
Figure 4-9ATrend Graph Display Screen
Operation Instructions:
z
Short time press “
” mode/OK key to shift the trend graph screens (as shown in Figure 4-9A , Figure 4-9B and Figure 4-9C)
z
Short time press "
" power/back key to return to record list
screen.
Figure 4-9B Trend Graph Display Screen
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Figure 4-9C Trend Graph Display Screen
4.5.2 Data Deletion
On the menu screen, longtime press “ ” key and the records list will appear. At this time, longtime pressing “
” key again, an message “Are you sure to delete all?” prompts on the screen, as shown in Figure 4-10.
Figure 4-10
At this time, press "" navigation key to select “Yes” or "No", and press “
” mode/OK key to confirm or exit. Or short
time press "
" power/back key to return to record list screen.
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5 Technical Specifications
A. Display Mode: Color dot-matrix LCD; B. Power Supply:
Supply voltage: d.c. 4.5V(3 AA alkaline batteries),
or d.c. 3.6V (Lithium rechargeable battery)
Operating current:
180mA
C. SpO
2
Measurement
Transducer: dual-wavelength LED sensor with wavelength:
Red light: 663 nm, Infrared light: 890 nm. Maximal optical output power:
< 2mW maximum average Measuring range: 35~100% Measuring accuracy:
Not greater than 3% for SpO
2
range from 70% to 100%
*NOTE: Accuracy defined as root-mean-square value of
deviation according to ISO 9919.
Low limit setting range: 50%~99% (Default setting: 90%).
D. Pulse Rate Measurement
Measuring range: 30bpm~240bpm Accuracy: ±2bpm or ±2% (whichever is greater) Over-limit setting range: 25bpm~250bpm Default setting limit: High -- 120bpm, Low -- 50bpm
E. Perfusion Index Display
Range: 0.2%~20%
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F. Data Update
8 beats moving average for both SpO
2
and pulse rate readings
G. Data Storage
Recording SpO
2
and pulse rate data every 1/2/4/8 second(s),
up to 384–hour records can be stored.
H. Low Perfusion Performance
The accuracy of SpO2and PR measurement still meet the precision described above when the modulation amplitude is as low as 0.5%.
I. Resistance to interference of surrounding light:
The difference between the SpO
2
value measured in the condition of indoor natural light and that of darkroom is less than ±1%.
J. Dimensions: 145 mm (L) × 74 mm (W) × 29 mm (H)
Net Weight: 210g (including batteries)
K. Classification
Type of protection against electric shock:
Internally powered equipment
Degree of protection:
Type BF applied parts.
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 Over-limit Indication
6.1 Limit settings
¾
SpO
2
low limit setting range: 50% ~ 99%.
¾
Pulse Rate limits setting range: High:
100bpm--240bpm Low: 30bpm--99bpm
During the measurement, if the measured value exceeds the preset value, the alert beeping sound will be activated, the value that is over-limit will blink at the same time.
6.2Alert sound mute setting
¾ During the measurement, if the alert sound is set to on,
short time press " " recall/mute key, then the alert sound will mute for 90 seconds, but the over-limited value still
keeps blinking. At this moment, the speaker volume icon becomes "
". If this alert event persists over 90 seconds,
then the alert sound will be activated again.
¾
During the measurement, if the probe is off or disconnected, the message "Check Probe" shows on the display screen. The alert sound starts (interval is 5 seconds) and lasts for about 1 minute. If the probe is still off, the Oximeter will power off a utomatically.
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7 Accessories
1. A probe
2. A holder
3. Battery(AA)×3
4. Charging cable (optional)
5. User Manual
6. Quality Inspection Certificate
7. A data cable (optional)
8. Oximeter Data Manager software (optional)
Note: The accessories are subject to change. See the Packing List for detailed items and quantity.
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8 Repair and Maintenance
8.1 Maintenance
The expectedservice life(not a warranty) of this device is 5 years. In orde
r
to ensure its long service life,
p
leasepay
attention to the maintenance;
y
Please change thebatteries when the low-voltage indicato
r
appears.
y
Please take out the
b
atteries if the oximeterwill notbe
used for a long time.
y
The recommende
d
storage environment of the device:
Ambient temperature: -20ºC ~60ºC Relative humidity 10%~95% Atmospheric pressure: 50kPa~107.4kPa
y
The oximete
r
is calibratedin the factorybefore sale, there
is no nee
d
to calibrate it during its life cycle. However, if it is necessary to verify its accuracy routinely, the use
r
can do the verification
b
y means of SpO2
simulator, o
r
it canbe doneby the local thir
d
p
arty test
house.
8.2 Cleaning and Disinfecting Instruction
y
Surface-clean senso
r
with a soft clothby wetting with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a 1:10bleach solution.
y
Then surface-clean
b
y a dampenedcloth andletitairdry
or wipe it with a cloth.
High-pressure disinfection cannot be used on the device. Do not immerse the device in liquid.
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9 Troubleshootin
g
Trouble Possible Reason Solution
Unstable SpO2and Pulse Rate display
1. The finger is not placed far enough inside.
2. The finger is shaking or the patient is moving.
1. Place the finger correctly inside and try again.
2. Reduce patient movement.
Device will not switch on
1. The batteries are drained or almost drained.
2. The batteries are not inserted properly.
3. The device is malfunctioning.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the local service center.
No Display
1. The device will power off automatically when there is no signal and no operation for 1 minute.
2. The batteries are almost drained.
1. Normal.
2. Change batteries.
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Appendix
Key of Symbols
Symbol
Descri
p
tion
Symbols
on the screen
%SpO
2
The oxygen saturation
PI%
Perfusion Index Pulse rate (Unit: beats per minute) Low battery voltage Battery fully charged icon Speaker mute icon
/ /
Speaker volume icon Memory full
/
(Neonate/Adult) Patient type
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27
S
y
mbol
Descri
p
tion
Symbols
on the
panels
SpO
2
SpO2probe connector Power/Back Key
Mode/OK Key Recall/Mute Key
¿/À Navigation Key
Data Interface CE mark
Serial number Date of manufacture
Authorised representative in the European community
Manufacturer (including address) With Type BF applied part See User Manual
Disposal of this device according to WEEE regulations
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28
Common Knowledge
1 Meaning of SpO
2
SpO2is the saturation percentage 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 physiological parameter to reflect the respiration function; it is calculated by the following method:
SpO
2
=HbO2/(HbO2+Hb)×100%
HbO2are the oxyhemoglobins (oxygenized hemoglobin), Hb are those hemoglobins which release oxygen.
2 Principle of Measurement
Based on Lamber-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 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
)and deoxygenated hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light (600nm~1000nm wavelength), by using these
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29
characteristics, SpO
2
can be determined. SpO2measured 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 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 reducing accidental death caused by hypoxia effectively.
3 Normal SpO
2
Range and Default Low Limit
In campagna area, healthy people’s SpO
2
value is greater than 94%, so the values below 94% are determined as hypoxia. SpO
2
<90% is considered as the default threshold
for determining anoxia by most researchers, so SpO
2
low
limit of the oximeter is set as 90% generally.
4 Factors affecting SpO2accuracy (interference reason)
Intravascular dyes such as indocyanine green or methylene blue
Exposure to e xcessive illumination, such as surgical
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30
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 pressure cuff, arterial catheter, or intravascular line
Exposure to the chamber with High pressure
oxygen
There is an arterial occlusion proximal to the sensor
Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing
5 Factors causing low SpO
2
value (pathology reason)
Hypoxemia disease, functional lack of HbO
2
Pigmentation or abnormal oxyhemoglobin level
Abnormal oxyhemoglobin variation
Methemoglobin disease
Sulfhemoglobinemia or arterial occlusion exists near sensor
Obvious venous pulsations
Peripheral arterial pulsation becomes weak
Peripheral blood supply is not enough
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