FaceLake CMS-50D Plus User manual

I
Instructions to User
Dear users, thank you very much for purchasing the
Pulse Oximeter.
This Manual is written and compiled in accordance
with the council directive MDD93/42/EEC for
medical devices and harmonized standards. In case
of modifications and software upgrades, the
information contained in this document is subject to
change without notice.
The Manual describes, in accordance with the Pulse
Oximeter’s features and requirements, main
structure, functions, specifications, correct methods
for transportation, installation, usage, operation,
repair, maintenance and storage, etc. as well as the
safety procedures to protect both the user and
equipment. Refer to the respective chapters for
details.
Please read the User Manual carefully before using
this product. The User Manual which describes the
operating procedures should be followed
strictly.Failure to follow the User Manual may cause
measuring abnormality, equipment damage and
human injury. The manufacturer is NOT responsible

II
for the safety, reliability and performance issues and
any monitoring abnormality, human injury and
equipment damage due to users' negligence of the
operation instructions. The manufacturer’s warranty
service does not cover such faults.
Owing to the forthcoming renovation, the specific
products you received may not be totally in
accordance with the description of this User Manual.
We would sincerely regret for that.
This product is medical device, which can be used
repeatedly.
WARNING:
Uncomfortable or painful feeling may appear
if using the device ceaselessly, especially for
the microcirculation barrier patients. It is
recommended that the sensor should not be
applied to the same finger for over 2 hours.
For the special patients, there should be a
more prudent inspecting in the placing
process. The device can not be clipped on the
edema and tender tissue.
III
The light (the infrared is invisible) emitted
from the device is harmful to the eyes, so the
user and the maintenance man should not
stare at the light.
Testee can not use enamel or other makeup.
Testee’s fingernail can not be too long.
Please refer to the correlative literature about
the clinical restrictions and caution.
This device is not intended for treatment.
The User Manual is published by our company. All
rights reserved.

IV
CONTENTS
1 Safety ...................................................................1
1.1 Instructions for safe operations ................ 1
1.2 Warning ..................................................... 1
1.3 Attention .................................................... 2
2 Overview ............................................................. 4
2.1 Features...................................................... 5
2.2 Major applications and scope of
application........................................................... 5
2.3 Environment requirements ....................... 5
3 Principle.............................................................. 6
4 Technical specifications ....................................7
4.1 Main performance..................................... 7
4.2 Main Parameters ....................................... 7
5 Installation..........................................................8
5.1 View of the front panel............................. 8
5.2 Battery installation.................................... 8
5.3 Accessories................................................ 9
6 Operating Guide ................................................ 9
6.1 Application method................................... 9
6.2 Attention for operation ......................... 14
6.3 Clinical restrictions................................. 15
7 Maintain、transportation and storage........16
7.1 Cleaning and Disinfecting...................... 16
7.2 Maintain................................................... 16
7.3 Transportation and storage ..................... 17
8 Troubleshooting ...............................................17
9 Key of Symbols ................................................19
10 Function Specification .....................................21
1
1 Safety
1.1 Instructions for safe operations
Check the main unit and all accessories
periodically to make sure that there is no visible
damage that may affect patient’s safety and
monitoring performance about cables and
transducers. It is recommended that the device
should be inspected once a week at least. When there
is obvious damage, stop using the device.
Necessary maintenance must be performed by
qualified service engineers ONLY. Users are not
permitted to maintain it by themselves.
The oximeter cannot be used together with
devices not specified in User’s Manual.Only the
accessory that appointed or recommendatory by
manufacture can be used with this device.
This product is calibrated before leaving factory.
1.2 Warning
Explosive hazard—DO NOT use the oximeter in
environment with inflammable gas such as some
ignitable anesthetic agents.
DO NOT use the oximeter while the testee
measured by MRI and CT.
The person who is allergic to rubber can not use
this device.

2
The disposal of scrap instrument and its
accessories and packings(including battery, plastic
bags, foams and paper boxes) should follow the
local laws and regulations.
Please check the packing before use to make
sure the device and accessories are totally in
accordance with the packing list, or else the device
may have the possibility of working abnormally.
Please choose the accessories and probe which
are approved or manufactured by the manufacturer,
or else it may damage the device.
Please don't measure this device with functional
tester for the device's related information.
1.3 Attention
Keep the oximeter away from dust, vibration,
corrosive substances, explosive materials, high
temperature and moisture.
If the oximeter gets wet, please stop operating it.
When it is carried from cold environment to
warm or humid environment, please do not use it
immediately.
DO NOT operate keys on front panel with sharp
materials.
High temperature or high pressure steam
disinfection of the oximeter is not permitted. Refer
to User Manual in the relative chapter (7.1)for
3
instructions of cleaning and disinfection.
Do not have the oximeter immerged in liquid.
When it needs cleaning, please wipe its surface with
medical alcohol by soft material. Do not spray any
liquid on the device directly.
When cleaning the device with water, the
temperature should be lower than 60℃.
As to the fingers which are too thin or too cold,
it would probably affect the normal measure of the
patients' SpO2and pulse rate, please clip the thick
finger such as thumb and middle finger deeply
enought into the probe.
The update period of data is less than 5 seconds,
which is changeable according to different
individual pulse rate.
Please read the measured value when the
waveform on screen is equably and steady-going,
This measured value is optimal value. And the
waveform at the monment is the standard one.
If some abnormal conditions appear on the
screen during test process, pull out the finger and
reinsert to restore normal use.
The device has normal useful life for three years
since the first electrified use.
The device may not work for all patients. If you
are unable to achieve stable readings, discontinue

4
use.
2 Overview
The pulse oxygen saturation is the percentage of
HbO2in the total Hb in the blood, so-called the O2
concentration in the blood. It is an important
bio-parameter for the respiration. A number of
diseases relating to respiratory system may cause the
decrease of SpO2in the blood, furthermore, some
other causes such as the malfunction of human
body's self-adjustment, damages during surgery, and
the injuries caused by some medical checkup would
also lead to the difficulty of oxygen supply in human
body, and the corresponding symptoms would
appear as a consequence, such as vertigo, impotence,
vomit etc. Serious symptoms might bring danger to
human's life. Therefore, prompt information of
patients' SpO2is of great help for the doctor to
discover the potential danger, and is of great
importance in the clinical medical field.
The Pulse Oximeter features in small volume, low
power consumption, convenient operation and being
portable.It is only necessary for patients to put one of
his fingers into a probe for diagnosis, and a display
screen will directly show the measured value of pulse
oxygen saturation with the high veracity and
5
repetition.
2.1 Features
A. Operation of the product is simple and convenient.
B. The product is small in volume, light in weight and
convenient in carrying.
C. Low power consumption
2.2 Major applications and scope of application
The Pulse Oximeter can be used in measuring the
pulse oxygen saturation and pulse rate through finger.
The product is suitable for being used in family,
hospital, oxygen bar, community healthcare, physical
care in sports (It can be used before or after doing
sports, and it is not recommended to use the device
during the process of having sport) and etc.
The problem of overrating would emerge
when the patient is suffering from toxicosis which
caused by carbon monoxide, the device is not
recommended to be used under this
circumstance.
2.3 Environment requirements
Storage Environment
a) Temperature :-40℃～+60℃
b) Relative humidity :5%～95%
c) Atmospheric pressure :500hPa～1060hPa
Operating Environment
a) Temperature:10℃～40℃

6
b) Relative Humidity :30%～75%
c) Atmospheric pressure:700hPa～1060hPa
3 Principle
Principle of the Oximeter is as follows: An
experience formula of data process is established
taking use of Lambert Beer Law according to
Spectrum Absorption Characteristics of Reductive
Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in
glow & near-infrared zones. Operation principle of
the device is: Photoelectric Oxyhemoglobin
Inspection Technology is adopted in accordance with
Capacity Pulse Scanning & Recording Technology,
so that two beams of different wavelength of lights
can be focused onto human nail tip through
perspective clamp finger-type sensor. Then
measured signal can be obtained by a photosensitive
element, information acquired through which will be
shown on screen through treatment in electronic
circuits and microprocessor.
Figure 1.
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4 Technical specifications
4.1 Main performance
A. SpO2value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator
appears before working abnormally which is due to
low-voltage
E. The display mode can be changed
F.With SpO2value and pulse rate value of storage,
the stored data can be uploaded to computers
4.2 Main Parameters
A. Measurement of SpO2
Measuring range: 0%～100％
Accuracy:
When the SpO2measuring range is 70%～100％,the
permission of absolute error is ±2％；
below 70% unspecified
B. Measurement of pulse rate
Measuring range:30bpm～250bpm
Accuracy: ±2 bpm or ±2% (select larger)
C. Resolution
SpO2: 1%, Pulse rate: 1bpm.
D. Measurement Performance in Weak Filling
Condition

8
SpO2and pulse rate can be shown correctly when
pulse-filling ratio is 0.4%. SpO2error is ±4%,
pulse rate error is ±2 bpm or ±2% (select larger).
E. Resistance to surrounding light
The deviation between the value measured in the
condition of man-made light or indoor natural light
and that of darkroom is less than ±1%.
F. Power supply requirement: : 2.6 V DC ~ 3.6V
DC.
G. Optical Sensor
Red light (wavelength is 660nm，6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
5 Installation
5.1 View of the front panel
Figure 2. front view
5.2 Battery installation
A. Refer to Figure 3. and insert the two AAA size
batteries properly in the right direction.
9
B. Replace the cover.
Please take care when you insert the batteries
for the improper insertion may damage the
device.
Figure 3.
5.3 Accessories
A. One hanging rope
B. Two dry batteries(AAA)
C. A User Manual
D. a data line
E. a disk (PC software)
6 Operating Guide
6.1 Application method
A.
a) Insert the two batteries properly to the direction,
and then replace the cover.
b) Open the clip as shown in Figure 4.
c) Let the patient’s finger put into the rubber

10
cushions of the clip (make sure the finger is in the
right position), and then clip the finger.
d) Do not shake the finger and keep the patient in
a stable state during the process.
e) The data can be read directly from the screen on
the measuring interface.
Fingernails and the luminescent tube should
be on the same side.
Figure 4.
Put finger in position
B. Change display direction
On the measuring interface, short press the button
to change the display.
C. Real-time data transmission setting
Firstly, please install the affiliated software into the
computer, and two icons would appear on the
desktop after installation. The icon of "SpO2 "is a
program for receiving real-time data which is shown
as figure 5; the icon of "SpO2 Review" is a program
for receiving stored data which is shown as figure 6.
11
a. Please connect the device to computer with the
affiliated data line , then double click the "SpO2
"icon to start the program.
b. When you unplug the data line from computer,
there is a dialog box "Save data at view" appearing
on the desktop, in which you can input some
patient's basic information.
Figure 5. SpO2program
Figure 6. SpO2 Review program
If the users choose to turn on the
synchronizing display function on computer, it
would probably take several seconds for the data
to appear on the computer screen.
D. Menu operations
When the device is under the measuring interface,
Press the button for about 1 second in order to enter

12
the menu interface shown as figure 7. Users can
adjust the setting through the main menu, such as
data storage. The specific operation methods are as
the following:
Figure 7. Main Menu Interface
a) Data storage setting
This instrument has the ability to store 24 hours
worth of data. It can store the measured pulse rate
and SpO2value accurately, transfer the data to the
computer, display the data and print reports (with the
included SpO2Software - Green Heart)
a. On the main menu interface, short press the
button to select “Record”, then long press the button
to choose whether store the data or not, choose “on”
to permit storing, choose “off”to forbid storing.
b. If the data storage function is being turned on,
when return to the measuring interface, a flashing
yellow dot would appear on screen, which means the
device is in a state of storing.
c. In the state of storing, the device is on
measuring interface, the sign "Recording" would
13
appear on the screen in 30 seconds, and then the
screen will be automatically shut down, only a
flashing yellow dot appear on screen.If short press
the button at this moment, the sign "Recording"
would appear on the screen, and then the screen will
be automatically shut down again; if long press the
button, the device would return to the measuring
interface.
d. If turning on the data storage function, the
former data storage will be automatically removed.
e. In the state of data storing, after the screen is
automatically shut down, the pulse sound indication
would be off for saving power.
f. When the storage space is full, it displays
“Memory is full”on the screen, and then shut down
in a few seconds. But it will still display “Memory is
full”by the next time you turn on the device on the
purpose of warning the user, and a few seconds later
enter the measuring interface.
b）Uploading the data to the PC after recording
a. Please connect the device with computer by the
data line which is equipped with the device, then
double click "SpO2 Review" icon to open"SpO2
Review" program, click the ‘New Session’Icon in
the software, enter the patient data and then click
‘ok’. The Software will then display “device

14
connected, waiting for data”.
b. on the main menu interface,the users to upload
the stored date to computer when the
symbol"Record"shows"off".
c. In the state of storing, it is not applicable for the
users to upload the stored date to computer.
c）Exit the main menu
On the main menu interface, Click the button to
select "Exit", then long press the button to exit the
main menu.
E. Power off
If the measuring finger out of the device on the
measuring interface,The device will power off
automatically when it gets no signal within 5
seconds.The device can't being power off when it is
in a state of storing.
6.2 Attention for operation
A. Please check the device before using, and
confirm that it can work normally.
B.The finger should be in a proper position (see the
attached illustration of figure 4 for reference), or else
it may result in inaccurate measure.
C.The SpO2sensor and photoelectric receiving
tube should be arranged in a way with the subject’s
arteriole in a position there between.
D.The SpO2sensor should not be used at a location
15
or limb tied with arterial canal or blood pressure
cuff or receiving intravenous injection.
E.Do not fix the SpO2sensor with adhesive or else
it may result in venous pulsation and inaccurate
measure of SpO2and pulse rate.
F.Excessive ambient light may affect the
measuring result. It includes fluorescent lamp, dual
ruby light, infrared heater, direct sunlight and etc.
G.Strenuous action of the subject or extreme
electrosurgical interference may also affect the
accuracy.
H.Testee can not use enamel or other makeup.
I.Please clean and disinfect the device after
operating according to the User Manual(7.1).
6.3 Clinical restrictions
A. As the measure is taken on the basis of arteriole
pulse, substantial pulsating blood flow of subject is
required. For a subject with weak pulse due to shock,
low ambient/body temperature, major bleeding, or
use of vascular contracting drug, the SpO2waveform
(PLETH) will decrease. In this case, the
measurement will be more sensitive to interference.
B.For those with a substantial amount of staining
dilution drug (such as methylene blue, indigo green
and acid indigo blue), or carbon monoxide
hemoglobin (COHb), or methionine (Me+Hb) or

16
thiosalicylic hemoglobin, and some with icterus
problem, the SpO2determination by this monitor
may be inaccurate.
C.The drugs like dopamine, procaine, prilocaine,
lidocaine and butacaine may also be a major factor
blamed for serious error of SpO2measure.
D.As the SpO2value serves as a reference value for
judgement of anemic anoxia and toxic anoxia, some
patients with serious anemia may also report good
SpO2measurement.
7 Maintain 、transportation and
storage
7.1 Cleaning and Disinfecting
Using medical alcohol to disinfect the device, nature
dry or clean it with clean soft cloth.
7.2 Maintain
A. Please clean and disinfect the device before using
according to the User Manual(7.1).
B. Please change the battery when the screen shows
.
C. Take out the battery if leave the equipment
unused for long time.
D. The device needs to be calibrated once a year (or
according to the calibrating program of hospital). It
also can be performed at the state-appointed agent or
17
just contact us for calibration.
7.3 Transportation and storage
A. The packed device can be transported by ordinary
conveyance or according to transport contract. The
device can not be transported mixed with toxic,
harmful, corrosive material .
B. The packed device should be stored in room with
no corrosive gases and good ventilation.
Temperature: -40°C~60°C; Humidity: ≤95%
8 Troubleshooting
Trouble Possible
Reason Solution
The
SpO2
and
Pulse
Rate
can not
be
displaye
d
normall
y
1. The finger
is not properly
positioned.
2. The
patient’s SpO2
is too low to
be detected.
1. Place the
finger properly
and try again.
2. Try again;
Go to a
hospital for a
diagnosis if
you are sure
the device
works all right.

18
The
SpO2
and
Pulse
Rate
are not
displaye
d stably
1. The finger
is not placed
inside deep
enough.
2. The finger
is shaking or
the patient is
moving.
1. Place the
finger properly
and try again.
2. Let the
patient keep
calm
The
device
can not
be
turned
on
1. 1. The
battery is
drained away
or almost
drained away.
2. The battery
is installed
incorrectly.
3.The
malfunction of
the device.
1.Please
change
batteries.
2.Please Install
the battery
again.
3. Please
contact the
local service
center.
The
display
is off
suddenl
y
1. The
device’s
malfunction.
2. The battery
is drained
away or almost
drained away.
1. Please
contact the
local service
center.
2.Please
change
batteries.
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9 Key of Symbols
Signal Description
Warning –See User Manual
%SpO2The pulse oxygen saturation(%)
PRbpm Pulse rate (bpm)
Low-voltage
menu button/power
button/function button
Type BF
SN Serial number
1. the finger clip falls off ( no
finger inserted)]
2. Probe error
3. Signal inadequacy indicator

20
battery positive electrode
battery cathode
USB
IPX1 Ingress of liquids rank
WEEE (2002/96/EC)
21
10 Function Specification
Information Display Mode
The Pulse
Oxygen
Saturation
（SpO2）
2-digit digital OLED
display
Pulse Rate（PR）3-digit digital OLED
display
Pulse Intensity
(bar-graph)
bar-graph OLED
display
SpO2Parameter Specification
Measuring range 0%～100%, (the
resolution is 1%).
Accuracy 70%～100%：±2% ,Below
70% unspecified.

22
Average value
Calculate the Average
value in every 4 measure
value.
The deviation between
average value and true
value does not exceed 1%.
Pulse Parameter Specification
Measuring range 30bpm～250bpm, (the
resolution is 1bpm)
Accuracy ±2bpm or±2% (select
larger)
Average pulse
rate
Moving calculate the
Average pulse rate every 4
cardio-beat,s cycle.
The deviation between
average value and true
value does not exceed 1%
Safety Type Interior Battery，ＢＦ
Type
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Pulse Intensity
Range
Continuous bar-graph
display, the higher display
indicate the stronger
pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries ×2 or
rechargeable battery
Battery working life
Two1.5V (AAA size)600mAh alkaline batteries
can work continually for 24 hours
Dimensions and Weight

24
Dimensions 58.5(L) ×31(W) ×32 (H)
mm
Weight About 50g (with the
batteries)

File Ver.: 0.9
Release Date: March. 2009