tOO
!l{l
85
1m
AV01'l1.llilt
Sa02
and
Sp02
Pules rate Bargraph Dispaly
•
Figure 3 Bland-Altman plot
75
10
Figure
5.
''"'
8
...
Of;
I
7
~
'a.
6
II'>
Ii
((;
g
4
'"
3
~
....
2
....
...
1
Q
~
N
0
~
-]
I,W
-z
<;,
'3
l>!,;
~i'ii
'4
"
~J.
""5
0
-6
"'~
-1
...
5
·8
<It>
II
,"-----
Figure 4. FrontView
•
Pules rate
---
......
~8
88
The display Sp02
------1++++88
~-t+t+!t------
Figure 2
SpOz
regression plot
~
One hanging rope;
~
Two batteries (optional);
~
One User Manual.
5
Accessories.
.
6 Installation
6.1 Viewofthe
Front
Panel
7
Operating
Guide .
6.2
Battery
Step1.Insert the two
AAA
size batteries properly inthe right direction.
Step 2. Putthe cover.
~lease
take
care
when
you
insert
the
batteries for
the
improper
insertion
may
damage
the
device.
6.3
Mounting
the
Hanging
Rope
Step
1.
Put theendofthe rope through·the hole.
Step 2. Put anotherend
of
the rope throughthe first one and then tightenit.
4 Technical Specifications
\
Glow and Infrared-ray
Receipt Tube
instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording
Technology~
so
that two beams
of
different wavelengthoflights 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.
7.4 Press the switch buttononce on front panel.
7.5 Do not shake the fmger andkeep the user at ease during theprocess. Meanwhile, human body is not recommended in movement status.
7.6 Get the information directlyfrom screen display.
7.7 In boot-strap state,pressbutton ,and the device is reset.
~
Fingernails
and
the
luminescent
tube
shouldbeon
the
same side.
Glow and Infrared-ray
Emission Tube
3.2
Caution
1.
The finger shouldbe placed properly (see the attachedillustrationofthis manual ,Figure 7), orelse it may cause inaccurate measurement.
2. The
SpOz
sensor andphotoelectric receiving tube should be arrangedin a way with the subject's arteriolein a position there between.
3.
The SpOz sensor shouldnot be used ata location or limb tied with arterial canal orblood pressure cuffor receiving intravenous injection.
4.
Make sure the opticalpathisfree from any optical obstacles like rubberizedfabric.
5.
Excessive ambient light mayaffect the measuring result. It includes fluorescent
lamp~
dual ruby
light~
infrared heater, directsunlightand etc.
6.
Strenuous actionofthe subject orextreme electrosurgical interference may also affectthe accuracy.
7.
User can not use enamel or othermakeup.
3.3 Clinical Restrictions
1.
As the measure is taken on the basisofarteriole pulse, substantial pulsating blood flowofsubject is required. For a subject with weak pulse due to
shock, low ambientlbody temperature, major bleeding, oruse
of
vascular contracting drug, the
SpOz
waveform (PLETH) will decrease. In this case,
the measurement will be moresensitive to interference.
2. 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 thiosalicylic hemoglobin, and some with icterus problem, the
SpOz determination by this monitor
may be inaccurate.
3.
The drugs like dopamine, procaine, prilocaine, lidocaineand butacaine may also be amajor factor blamed forseriouserrorofSpOz measure.
4. As the SpOz value serves as a reference value for judgement
of
anemic anoxia and toxic
anoxia~
some users with serious anemia may also report
good SpOz measurement.
8 Re airing
and
Maintenance
7.1
Insert thetwobatteries properlytothe direction, and thenput the cover.
7.2 Open the
clip.
7.3 Let the user's finger put into the rubber cushionsofthe clip (make sure the finger is in the right position), and
then!
clip the finger. As shown in
Figure 5
1)
Display
Format:
Digital tube Display;
SpOz
Measuring
Range: 0% - 100%;
Pulse
Rate
Measuring
Range: 30 bpm - 250 bpm;
Pulse IntensityDisplay: columniation display
2) Power Requirements: 2
x1.5V
AAA
alkaline battery, adaptable range: 2.6V-3.6V.
3) Power
Consumption:
Smaller than
25
rnA.
4) Resolution: 1% for
SpOz
and 1 bpmfor Pulse Rate.
5)
Measurement
Accuracy: ±2% in stageof70%-100% SpOz, and meaningless when stage being smaller than 70%. ±2 bpm or±2% (select larger) for
Pulse Rate. Clinical Trial :SpOz regression plot
& Bland-Altman plot,Refer toFigure2 & Figure
3.
6)
Measurement
PerformanceinWeak
Filling Condition: SpOz and pulse rate can be shown correctly when pulse-filling ratio is 0.4%.
SpOz
error
is
±4%, pulse rateerror is ±2 bpm or±2% (select larger).
7) Resistance to
surrounding
light: The deviation between the value measured in the conditionofman-made light, indoor natural light and that
of
darkroomisless than±l%.
8)Itis
equipped with a switch function. The Oxirpeter can be powered offwhen the fingerisoff
the oximeter within 5seconds.
9) Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
Figure
1.
Operating Principle
~
Please change the batterieswhen the low-voltage displayed onthe screen.
~
Please clean the surfaceofthe device before using. Wipe the device with medical alcoholfirst, and then let it dryin air or clean itby dry clean fabric.
~
Using the medical alcoholto disinfect the product afteruse, prevent from cross infectionfor next time use.
~
Please take outthe batteriesifthe oximeter is notin use for a long time.
~
The packed device canbe transported by ordinary conveyance or according to transport contract.The device can notbe transported mixed with toxic,
harmful, corrosive material.
~
The best storageenvironmentofthe device is - 40°C to
60°C
ambient temperature andnot higher than 95%relative humidity.
~
Users are advised to calibrate the device termly (or according to the calibrating programofhospital). It also can be performed at the state-appointed
agent orjust contactus for calibration.
&.
High-pressure sterilization
cannotbeused on
the
device.
&.
Do
not
immerse
the
deviceinliquid.
&.
It
is recommended
that
the
device shouldbekept
in a
dry
environment. Humidity
may
reduce
the
useful lifeofthe
device,oreven
damage
File No.:CMS2.782.395(OCH)ESS/1.0
Release Date: June 2016
1.4.01.01.393
Address:
No.112 Qinhuang WestStreet, Economic &Technical Development Zone,
Qinhuangdao, Hebei Province, PEOPLE'S REPUBLIC OF CHINA
Tel:
0086-335-8015430
Fax: 0086-335-8015588
Technical support: 0086-335-8015431
E-mail:cms@contecmed.com.cn
contec88@gmail.com
Website: http://www.contecmed.com
CONTEC™
Contec
Medical
Systems
Co.,
Ltd.
Instructions to User
recommended tobeused
under
this circumstance.
The pulse oxygen saturation is the percentage
of
HbOz in the total Hb in the blood, so-called theOzconcentration in the blood. It is an important
bio-parameter
for the respiration. For the purposeofmeasuring the
SpOz
more easily and accurately, our company developed the Pulse Oximeter. At the
same time, the device canmeasure the pulse rate simultaneously.
The Pulse Oximeter features in smallvolume, low powerconsumption, convenient operation and being portable. It is only necessary for user to put one
of
his fmgers into a fingertip photoelectric sensorfor diagnosis, and a display screenwill directly show measured valueofHemoglobin Saturation.
2.1 Features
~
Operationofthe product is simple andconvenient.
~
The product is small in volume, light in weight (total weightis about 50gincludingbatteries) and convenient in carrying.
~
Power consumptionofthe product is lowand the two originally equippedAAA batteries canbe operated continuouslyfor24 hours.
~
The product will automatically be powered
off
when no signal is in the productwithin 5 seconds.
~
Low - battery indicatoras battery icon flash manner.
2.2
Major
Applications
and
ScopeofApplication
The Pulse Oximeter can be used in measuring pulse oxygen saturation and pulseratethroughfinger. The product is suitable for family use(It can be used
before orafter doing sports, and it is notrecommended to use the device during the process
of
doing sports) .
~
The
problemofoverrating would emerge when
the
user
is suffering from toxicosis which causedbycarbon
monoxide,
the
device is
not
CMS50M
2 Overview
Dear users, thankyou very much for purchasingthe Pulse Oximeter.
In case
of
modifications and software upgrades, the informationcontained in this document is subject tochangewithout 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 boththe user and equipment.
Refer tothe 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
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'swarranty service does not cover suchfaults.
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 regretfor that.
This product canbe used repeatedly. The operating life is 3years.
If
you have anyquestions regarding to the useofthis product, please callusat 1-847-562-1702 Monday-Friday from 8:00AM to 5:00 PM Eastern Time.
WARNING:
~
Uncomfortableorpainful feeling may
appearifusing
the
device
cea~elessly,
especially for
the
the
microcirculation
barrier
users.Itis
recommended
that
the
sensor should
notbeapplied to
the
same fingerfor
over
2 hours.
r
For
the
special users,
there
shouldbea
more
prudent
inspecting in
the
placing process.
The
device
can
notbeclipped on
the
edema
and
tender
tissue.
~
The
light (the
infrared
is invisible)
emitted
from
the
device is
harmfultothe
eyes, so
the
user
and
the
maintenance
man
should
not
stare
at
the
light.
r User
can
not
use enamelorother
makeup.
r
User's
fingernail can
notbetoo long.
r Please refer to
the
correlative
literature
about
the
clinical restrictions
and
caution.
r This device is
not
intended
for
treatment.
The User Manualispublished by our company. Allrightsreserved.
Pulse
Oximeter
(UJ~~lr
[tMtl~lJillYl~O
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 user'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 oximeter .
~
Necessary maintenance must be performedby qualified engineers
ONLY.
Users are notpermitted to maintain it by themselves.
~
The oximeter cannot be used together with devices not specifiedinUser's Manual.Only the accessory that appointed or recommendatory by
manufacture can beusedwith this device.
~
This product is calibratedbefore leaving factory.
1.2 Warnings
~
Explosive
hazard-DO
NOT use theoximeter in environment with inflammable gas suchassome ignitable anesthetic agents.
~
The personwho is allergic to rubber can not use this device.
~
The disposalofscrap 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 don't measurethis device with function testpaper for the device's related information.
~
Partsofthe device that are notserviced or maintained while in usewith the user.
};-
WarninKagainst servicing and maintenance while themeequipment isinuse.
~
No modificationofthis equipment is allowed.
~
The userisan intended operator.
~
The probeofthe device is the applied part.
1.3 Attentions
G Keep the oximeter awayfromdust, vibration, corrosive substances, explosive materials, high temperature and moisture.
G
If
the oximeter getswet, please stop operating it.
G When it
is
carried from cold environment to warm or humid environment,please do not use it immediately.
G DO NOT operate keys on front panelwith sharp materials.
G High temperature or high pressure steam disinfection
of
the oximeter is notpermitted. Refer to User Manual in the relative chapterfor instructions
of
cleaning and disinfection.
G 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.
G When cleaning the devicewith water, the temperature should belower than 60°C.
G As to the fingers which are too thin or too cold, it would probably affect the normal measure
of
the users'
Sp02
and pulse rate, please clip the thick
finger such as thumb andmiddle finger deeply enough intothe probe.
G Do not usethedeviceon infant or neonatal users.
G The product
is
suitable for adults(Weight shouldbe between 40kg to 1IOkg).
G The device may not work for all users.
If
you are unable toachieve stable readings, discontinue use.
G The update period
of
data is less than 5seconds, whichischangeable according to different individual pulse rate.
G
If
some abnormal conditions appearon the screen during testprocess, pull out the finger and reinsert torestore normal use.
G The hanging rope attached the product is made from Non- allergy material,
if
particular group are sensitive to the hanging rope, stop using it. In
addition, pay attentionto the use
of
the hanging
rope,
do not wearit around the neck avoiding cause harm tothe users.
G The instrument dose not have low-voltage alarm function, it only shows the low-voltage,please change the battery when the battery energy is used
out.
G When the parameter
is
particularly, The instrument dose not have alarm function.Do not use the deviceinsituationswhere alarms are required.
G Batteries must be removed
if
the device is going to be storedfor more than one month, orelse batteries may leak.
G A flexible circuit connectsthe two parts
of
the device. Do nottwist or pull on the connection.
1.4.Indication forUse
The Pulse Oximeteris a non-invasive device intended for the spot-check
of
saturationofarterial hemoglobin(Sp02) andthe pulse rateofadult in home
use environments.This device is not intendedfor continuous monitoring.The device can be multi-used.Solely for use withsporting and aviation
activities.Intended to monitorheart rate during exercise.
2.3
Environment
Requirements
Storage Environment
a) Temperature
:-40°C~+60°C
b) Relative humidity
::::s
95%
c) Atmospheric pressure
:500hPa~1060hPa
Operating Environment
a) Temperature:
:10°C~40°C
b) Relative Humidity
::::S75%
c) Atmospheric
pressure:700hPa~
1060hPa
3 Principle
and
Caution
it.
3.1 Principle
of
Measurement
Principleofthe Oximeter isasfollows: An experience formulaofdata process is established taking useofLambert Beer Law according to Spectrum
Absorption Characteristics
of
Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbOz) in glow & near-infrared zones. Operation principleofthe