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User Manual for Handheld Puls e 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. Please follow
these instructions to oper a t e .
No part of this manual may be photocopied, reproduced or
translated into another language without the prior written
consent. Creative reserves the right to revise and amend it at any
time without prior notice.
Versio n of the Manual: Ver 1.1
December 5, 2012
All rights reserved.
Notes:
The contents contained in this manual are subjected to
change without prior notice.
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.
3502-2290040
Instructions for Safe Operations
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Check the device before using it to make sure that th ere is
no visible damage that may affect user’s safety and its
performance. When there is obvious damage, stop using
the device.
Necessary service must be performed by qualified service
engineers ONLY. Users are not permitted to repair it by
themselves.
The oximeter cannot be used together with the devices
not specified in User Manual.
Cautions
Explosive hazard—DO NOT use the oximeter in
environment with inflammable gas such as some ignitable
anesthetic agents.
DO NOT use the oximeter whi le the testee is un der MRI
or CT scanning.
Warnings
The uncomfortable or painful feeling may appear if using
the sensor of this device continuously on the same place
for a long time, especially for the patients with poor
microcirculation. It is recommended that the sensor
should not be applied to the same location for over 2
hours. If any abnormal condition is found, please change
the position of sensor.
For the individual patients, there should be a more
prudent inspecting in the placing process. The sensor can
not be clip pe d on the edema and tender tissue.
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To dispose the device or its accessories, the local law
should be followed.
Attentions
Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and
moisture.
If th e oximeter gets wet, please stop operating it. When it
is carried from cold environment to warm and humid
environment, please do not us e it immediately.
DO NOT operate the button on front panel with sharp
materials.
High temperature or high pressure steam disinfection to
the oximeter is not permitted. Refer to related chapter for
instructions of cleaning and disinfection.
The intended use of this device is not for therapy purpose.
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 Name and Model ............................................................. 2
1.3 Str uc t ur e .......................................................................... 3
1.4 Features ........................................................................... 3
1.5 Scope of Applicat ion ... Hiba! A könyvjelző nem létezik.
1.6 Working Enviro nment ..................................................... 3
2 Inst a llati on of Battery and Holder ....................................... 4
3 SpO2 Probe Connectio n ........................................................ 5
4 Operation ............................................................................... 7
4.1 Defaul t Screen ................................................................. 7
4.2 Indication for No Signal .................................................. 9
4.3 Setting Mode ................................................................... 9
4.4 Low Battery Promption ................................................. 16
5 Technical Specificat ions ...................................................... 17
6 Accessories ........................................................................... 19
7 Repair and Maintenance .................................................... 20
7.1 Maintenance .................................................................. 20
7.2 Cleaning and Disinfecting Instruction ........................... 20
8 Troubleshooting ................................................................... 21
Appendix ................................................................................. 22
Key of Symbols ................................................................... 22
Common Knowledge for SpO
2
Measurement ..................... 23
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1 Overview
1.1 Appearance
Figure 1
1. Display screen: display SpO
2
and PR values etc. data.
2. / (Navigat ion key ):
When on the system setup screen , press it to choose the setting
item or adjust par ameter values.
3. (Setting/OK):
Navigati on key
Setting/OK
Power/Back
Backlight/Mute
Display sc reen
Reserved port
Data interface
SpO
2
probe
connector
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Longtime press: enter setting mode;
Short time press: press to confirm;
4.
(Data interface): used for uploading data.
5. (Reserved port): reserved for future use.
6. (Power/Back):
Longtime press: turn the power on/off;
Short time press: exit the setting mode or back to previous
setting item.
7.
(Backlight/Mute):
Longtime press: make the device stay in mute mode or turn
the sounds on; this function is only effective during
measuring;
Short time press: turn the backlight on/off;
8. Icon: “SpO
2
”: SpO2 Probe Connector.
Key definit ions:
Longtime press: press for 2 seconds or long e r ;
Mute mode: ex cept th e key-press sound, other sounds (i. e. b eat
sound and alarm sound) shall be off.
1.2 Name and Model
Name: Handheld Pulse Oximeter
Model: PC-66A
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1.3 Structure
It consists of the main unit and SpO2 probe.
1.4 Features
It is light, small in size and easy to carry;
Segment LCD d isplay, with LED backlight;
Monitor SpO
2
and PR parameters simultaneously, and
display pulse intensity bar graph as well;
SpO
2
and PR etc. dat a storage and transmission to PC for
viewing and analysis;
Audible & Visual alarm function;
Alkaline batteries or rechargeable batteries can be used
and with power management function;
Time setup and display function;
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
Operatin g t emper ature: 5~40 ℃
Operating humidity: 30~80%
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Atmospheric pressure: 70kPa~106kPa
2 Installation of Battery and Holder
1） Open the rear panel with coin or an ordinary flat
screwdriver, as shown in Figure 2.
Figure 2
2） According to the polarity mark, insert three AA batteries
into battery house, as shown in Figure 3.
Figure 3
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3） Close the bat tery cover and fasten it.
4） Fixing Holder
Figure 4 Fixing Holder
3 SpO2 Probe Connection
Connect the SpO2 probe to the right panel’s connector labeled
“SpO
2
”. After starting the monitor insert one finger into the
probe (index finger, middle finger or ring finger with proper
nail length) according to demonstration, as shown in the
following figure.
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Figure 5 Demonstration for using SpO2 probe (finger clip)
Instructions of Operation
1. The finger should be put properly and correctly.
2. Do not shake the finger and keep at ease during using.
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.
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 valu e is exp ected by waitin g for a whil e, o r a rest art i s
needed when necessary.
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4 Operation
4.1 Default Screen
Longtime press “ ” key to start the Oximeter, then insert fin ger
into rubber cushions of the probe, the screen will display the
default screen, as shown in Figure 6.
Figure 6 Default Screen
Screen Description:
“%SpO2” “99”: SpO2 value; “99” is a percentage valu e;
“
BPM 78”: Pulse rate value: 78bpm.
“
”: Battery indication; when low battery power is
detected b y the o ximeter d u rin g measure ment , this icon will
change to be “
” and blinks for reminding user to
replace bat teries as soon as possible.
“12:00”: Current time;
“ ”：
pulse strength bar-graph;
%SpO
2
BPM
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“ ”: Sound indication；When the icon becomes “ ”, the
oximeter stays in mute mode.
Prompt for Data Storage
If the memo r y is ful l or the total number of the records reaches
256 pieces during measuring, the earliest records will be
overwritten and the icon “ ” will display on the screen for
prompt, as shown in the figure below.
Figure 7
The record in terval i s 2s econd s, that is th e oximeter recor ds a
group of SpO
2
value and PR value every 2 seconds. The
length of data record is limited to 30 seconds at least and
truncated to 2 hours at most.
You can clear the memory (deleting all the records) via
restoring default factory setting or by data manager
software(optional).
Note: It is suggested that the data shall be uploaded to
computer for saving, or the earliest records will be
overwritten.
Memory
Full icon
%SpO
2
BPM
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4.2 Indicatio n for No Signal
If No Signal icon “ ” prompts on screen (as shown in Figure
8), please check whether the probe connects well and whether
the finger is in appropriate position.
Figure 8 No Signal
4.3 Setting Mode
When the oximeter stays in measuring mode, longtime press
“ ” key for entering into setting mode (as shown in Figure 9).
Figure 9 Setting Screen
There are 4 setting icons: “%SpO
2
BPM”, “ ”, “ ”or
“
”, and “ ” on setting screen. When entering into its
corresponding sett ing screen, you may view the current settings,
%SpO
2
BPM
No signal
icon
%SpO
2
BPM
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or may modify them.
Screen Description:
Icon “%SpO
2
BPM” is for setting Low alarm limit of
SpO2 and High/Low alarms of PR;
Icon “ ” is for setting date and ti me;
Icon “ ” or “ ” which indicates the current status of
sound is for setting sound status;
Icon “ ” indicates the data uploading mode;
Operat ion Instruc tions:
1） Press “/” Navigation key to choose the setting item
(icon). The curren t selected setting icon starts to flash.
2） Press “ ” key to confirm and enter into its corresponding
setting screen or data uploading screen.
Note: The measurement will be terminated when entering into
setting mode or data uploading mode.
4.3.1 Sp O
2
/PR Alarm Settings
On the setting screen, select “
” and then press
“
” key for entering into SpO2 alarm setting screen and PR
Hi/Low alarm limit setting screen. The setting screens are as
shown in the following figures.
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Figure 10A SpO2 alarm setting
Figure 10B PR Low limit setting Figure 10C PR Hi lim it sett ing scre e n
Operat ion Instruc tions:
1. “%SpO
2
Lo”: SpO2 alarm setting; default value: “85%”;
Read the following f or t he detailed setting method:
a. When the display screen is SpO
2
alar m setti ng screen , press
“
” key to active S pO2 alarm setting o pt ion, the preset valu e
starts to flash;
b. Press “”/ “” (Navigation key) to adjust numerical value.
“”： short time press it to increase the numerical value
single time; longtime press it to increase the numerical value
continuously;
“”： short time press it to reduce the numerical value single
time; longtime press it to reduce the numerical value
BPM
BPM
%SpO
2
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continuously;
c. Press “ ” key to confirm the modification.
d. Press “”/ “” (Navigation key) circularly, the display
screen will be shift among SpO
2
alarm setting screen, PR
Low limit setting screen and PR Hi limit setting screen.
You can follow the setting steps mentioned abo ve to adjust
PR Low/Hi limit;
e. After completing the settings, short time press “
” key t o
return to menu screen;
2. “ BPM Lo”: High alarm limit setting of pulse rate;
default value: 120bpm;
3. “ BPM HI”: Pulse rate: Low alarm limit setting of
pulse rate; default value: 50 bpm.
When the measuring value exceeds the preset value, the
oximeter will alarm and backlight will be turned on
automatically, the corresponding value displayed on screen will
flash as well. At this time, press “
” key to turn the backligh t
off.
4.3.2 Date and time Settings
On the setting screen , select “
” and then press “ ” key for
entering into date and time setting screen. The sett in g screens are
as shown in the following figures.
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Figure 11A Year Setting Fig ure 11B Month Setting
Figure 11C Day Setting
Figure 11D Hour Setting Fi gure 11E Minute Setting
Operat ion Instruc tions:
1.“
”
：
Year Settin g.
Read the following for the detailed setting method:
a. When th e display screen is Year setting screen, p ress “
”
key to active Year setting option, the preset value starts to
flash;
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b. Press “”/ “” (Navigation key) to adjust year.
“”：short time press it to increase the numerical value
single time; longtime press it to increase the numerical
value continuously;
“”：short time press it to reduce the numerical value single
time; longtime press it to reduce the numerical value
continuously;
c. Press “
” key to confirm the setting.
d. Press “”/ “” (Navigation key) circularly, the display
screen will be shift among Year setting screen, Month
setting screen, Day setting screen, Hour setting screen and
Minute setting screen. You can follow the setting steps
mentioned above to adjust;
e. After completing the settings, short time press“
”ke y t o
return to setting screen;
2. “ ”：Month setting;
3.“ ”： Day setting;
4.“ ”： Hour setting;
5. “ ”： Minute setting;
4.3.3 Sound Sett ing
On the setting screen, s elect “ ” or “ ” and then p ress “ ”
key for entering into Sound setting screen, as shown in the figure
below.
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Figure 12A Sound On Figur e 12B Mute Setting
Operat ion Instruc tions:
Press “”/ “” (Navigation key) to turn the sound on or make
the oximeter stay in mute mode. Default setting is “ON”;
“ON”: the sound setting is ON,
“OFF”: the sound setting is OFF, the oximeter stays in mute
mode.
4.3.4 Upload Dat a
On the setting screen, s elect “
” and then press “ ” ke y for
entering into data uploading screen (as shown in Figure 13).
When you transmit data (SpO
2
and PR values) to your computer,
please let the oximeter stay in connecting status.
Figure 13 Data uploading Screen(Connecting Status)
%SpO
2
BPM
%SpO2
BPM
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4.4 Low Battery Prompt
When the battery is too low, if you power up the oximeter, it
will display as the figure below to indicate low battery. Please
replace th e batteries, or the oximeter may not work.
Figure 14
4.5 Resume Default Setting
When the oximeter is off, press the “
” key, “” key and
“ ”at the same time until the default setting display is shown
on the screen , it indicates the operatio n has succeeded .
Figure 15 default setting screen
After restoring d efault setting, all the record stored in oximeter
will be cleared, but the time will not be changed.
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5 Technical Specifications
A. Displ ay mode：Segment LCD Display
B. Power supply requirement:
3 ×LR6 (AA) alkaline battery or Ni-MH rechargeable
batteries;
Supply voltage: 4.5V
Operating current: <50mA
C. SpO
2
Parameter Specifi cations
Transducer: dual-wavelength LED sensor
Measure ment wavel ength:
Red light: 660 nm, Infrared light: 905 nm.
Maximal optical output power:
Less than 2mW maximum average
Measuring range: 35~99%
Measuring accuracy:
not greater than 3% for SpO
2
range from 70% to 100%
Note: Accuracy is defined as root-mean-square value of
deviation according to ISO 9919.
SpO
2
low alarm limit setting range: 85%~99% (default
85%)
D. Pulse Rate Parameter Specifi cations
Measuring range: 30bpm~240bpm
Accuracy: ±2bpm or ±2% (whichever is greater)
Alarm limit setting range: 30bpm~240bpm
Default alarm limits: High: 120bpm Low: 50bpm
E. Perfus ion Index (P I) Display
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Range: 0~20%
F. Data Record
The record i nterval is 2 second s, that is the oximeter reco rds
a group of SpO
2
value and PR value every 2 seconds. The
length of a record is limited to 30 seconds at least and
truncated 2 hours at most. Up to 12-hour data can be
recorded.
G. Resistance t o i nterference of surrounding light:
The difference bet ween th e value measured in th e con dition
of indoor natural light and that of darkroom is less than
±1%.
H. The performance under low perfusion co nditi on
The accuracy of SpO
2
and PR measurement still meet the
precision described above when the modulation amplitude
is as low as 0.5%.
I. Resistance t o 50Hz/60Hz interference
SpO
2
and PR are precise which have been tested by
BIO-TEK pulse oximeter simulator.
J. Dimensions: 145 mm (L) × 74 mm (W) × 29 mm (H)
Net Weight: 140g (not including batteries and accessories)
K. Classification
The type of protection against el ectric shock:
Internally powered equipment
The degree of protectio n ag ai nst electric s hock:
Type BF applied parts.
The degree of protection against harmful ingress of
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liquids: Ordinary equipment without protection against
ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
6 Accessories
1. A probe
2. A holder
3. Battery（AA）× 3
4. A User M anual
5. A Quality Certificate
6. A dat a cable (op tional)
7. Oximeter Data Man ager software ( optional)
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 life of this device is 5 years. In order to ensure its long
service life, please pay attention to the maintenance.
A. Please change th e batteries when the low-voltage indicator
appears.
B. Please take out the batteries if the oximeter will not be
used for a long time.
C. The recommended storage environment of the device:
Ambient temperature: -20ºC ~60ºC
Relative humidity 10%~95%
Atmospheric pressure: 50kPa~107.4kPa
D. The oximeter is calibr ated in the factory before sale, th ere
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.
7.2 Cleaning and Disi n fecting Instruction
A. 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.
B. Then surface-clean by a dampened cloth and let it air dry
or wipe it with a cloth.
High-pressure sterilization cannot be used on the device.
Do not immerse the device i n liquid.
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8 Troubleshooting
Trouble
Possible Reason
Solution
The SpO
2
and Pulse
Rate
display
instable
1. The f inger is not
placed inside
enough.
2. The finger is
shaking or the
patient is moving.
1. Place the finger
properly and try again.
2. Le t the p atient keep
calm.
Can not
turn on
the device
1. The batteries are
drained or almost
drained.
2. The batteries are
not insert e d
properly.
3. The device’s
malfunction.
1. Change b atteries.
2. Reinstall batteries.
3. Please contact the
local service center.
No
Display
1. The device will
power off
automaticall y when
there is no signal
and no opera ti o n for
1 minute.
2. The batteries are
almost drained.
1. Normal.
2. Change batt eries.
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Appendix
Key of Symbols
Symbol
Description
Symbols
on the
screen
%SpO2
Pulse oxygen saturation
Pulse rate (Unit: beats per minute)
Low battery voltage
Memory full
No signal
Pulse stre ngth bar-graph
Date and time setup
Conneti ng to PC
Sound icon
Mute icon
Symbols
on the
panels
With Ty pe BF applied part
SpO
2
SpO2 probe connector
Power/Back Key
Setting/OK Key
Backlight/Mute Key
/
Navigatio n Key
Data Interface
SN
Serial Number
Separate co llection for t his device.
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Common Knowledge for SpO2 Measurement
1 Meaning of SpO
2
SpO2 is 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:
SpO2 = HbO2/ (H bO2 +Hb)×100%
HbO
2
are the oxyhemoglobins (oxygenized hemoglobin),
Hb are those hemoglobins which release oxygen.
2 Principle of Measurement
Based on Lamber-Beer law, th e light absorbance of a given
substance is directly proportional with its density or
concentration. When the light with certain wavelength
emits on human tissu e, th e 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
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
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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 th e respiratio n
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 b y measure ment
and find the hypoxemia patient earlier, thereby preventing
or reducing accidental death caused by hypoxia effectively.
3 Normal SpO2 Range and Default Low Alarm Limit
In Campagna area, healthy people’s SpO2 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
alarm limit of the oximeter is set as 90% gen erally.
4 Factors affect SpO
2
measuring accuracy (interference
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.
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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 cat heter, or intravascular line
Exposure to the chamber with High pressure
oxygen
There is arterial occlusion proximal to the sensor
Blo od vess el cont raction caused by peripher al vessel
hyperkinesias or body temperature decreasing
5 Factors caused low SpO
2
Measuring value (pathology
reason)
Hypoxemia disease, functional lack of HbO2
Pigmentation or abnormal oxyhemoglobin level
Abnormal oxyhemoglobin variation
Methemoglobin disease
Sulfhemoglobinemia or art erial o cclu sion exists near
sensor
Obvious venous pulsations
Peripheral arterial pulsat ion becomes weak
Peripheral blood supply is not enough
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