CMS50S
User Manual
P u l s e O x i m e t e r
Contec Medical Systems Co., Ltd.
Address:No.112 Qinhuang West Street, Economic
＆
Technical Development Zone,Qinhuangdao,Hebei
Province,
PEOPLE’S REPUBLIC OF
CHINA
Tel: +86-335-8015430
Fax:+86-335-8015588
Technical s86-335-8015431
E-mail:[email protected]
Website:http://www.contecmed.com
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Tel:
＋
49-40-2513175
Fax:
＋
49-40-255726
E-mail:
CMS2.782.492(CE)ESS/1.0 1.4.01.01.798 2021.04
User Notice
Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter
referred to as device).
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.
It is a medical device, which can be used repeatedly.
The Manual describes, in accordance with the device
’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 device. Refer to the respective chapters
for details.
Please read the User Manual carefully before using this device. The User Manual
which describes the operating procedures should be followed strictly. Failure to
follow the User Manual may cause measuring abnormality, device damage and
human injury. The manufacturer is NOT responsible for the safety, reliability and
performance issues and any monitoring abnormality, human injury and device
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.
Our company has the final interpretation to this manual. The content of this manual is
subject to change without prior notice.
Warnings
Remind that it may cause serious consequences to tester, user or environment.
Explosive hazard
—
DO NOT use the device in environment with inflammable
gas such as anesthetic.
DO NOT use the device while examining by MRI or CT, as the induced current
may cause burn.
Do not take the information displayed on the device as the sole basis for clinical
diagnosis. The device is only used as an auxiliary means in diagnosis. And it must be
used in conjunction with doctor’s advice, clinical manifestations and symptoms.
The maintenance to the device or replacement of the batterycan only be
performed by qualified service personnel specified by manufacturer, dangers
(such as over-temperature, fire or explosion) may occur when replacing the
battery by the personnel not fully trained. Users are not permitted to maintain or
refit the device by themselves.
Uncomfortable or painful feeling may appear if using the device ceaselessly,
especially for the microcirculation disturbance users. It is not recommended that
the sensor is used on the same finger for more than 2 hours.
For some special users who need a more careful inspection on the test site,
please don’t place the device on the edema or tender tissue.
Please do not stare at the red and infrared light emitter (the infrared light is
invisible) after turning on the device, including the maintenance staff, as it may
be harmful to the eyes.
The device contains silicone, PVC, TPU, TPE and ABS materials, whose
biocompatibility has been tested in accordance with the requirements in ISO
10993-1, and it has passed the recommended biocompatibility test. The person
who is allergic to silicone, PVC, TPU, TPE or ABS can not use this device.
The disposal of scrap device, its accessories and packaging should follow the local
laws and regulations, to avoid polluting to the local environment. And the packaging
materials must be placed in the region where the children are out of reaching.
The device can not be used with the equipment not specified in the Manual. Only the
accessories appointed or recommended by the manufacturer can be used, otherwise it
may cause injury to the tester and operator or damage to the device.
The SpO
2
probe accompanied is only suitable for using with the device. The
device can only use the SpO
2
probe described in the Manual, so the operator has
the responsibility to check the compatibility between the device and the SpO
2
probe before using, incompatible accessories may cause device performance
degradation, device damage or user injury.
Do not reprocess the accompanying SpO
2
probe.
Check the device before use to make sure that there is no visible damage that
may affect user’s safety and device performance. When there is obvious damage, please
replace the damaged parts before use.
When the message ―Sensor Off‖ or ―Sensor Fault‖ appears, it indicates that the SpO
2
probe is disconnected or line fault occurs. Check the connection of the SpO
2
probe and
whether there is damage for the probe, if necessary, please replace the probe to avoid
risks. The probe fault will not result in a safety hazard.
Functional testers can not be used to assess the accuracy of the SpO
2
probe and Pulse
Oximeter.
Some functional testers or patient simulators can be used to verify whether the device
works normally, for example, INDEX-2LFE Simulator (software version: 3.00), please
refer to the Manual for the detailed operation steps.
Some functional testers or patient simulators can measure the accuracy of the device
copied calibration curve, but they can not be used to evaluate the device accuracy.
When using the device, please keep it away from the equipment which can generate strong
electric field or strong magnetic field. Using the device in an inappropriate environment may
cause interference to the surrounding radio equipment or affect its working.
When storing the device, keep it away from children, pets and insects to avoid affecting its
performance.
Do not place the device in places exposed to direct sunlight, high temperature, humidity, dust,
cotton wool or easy to splash water, to avoid affecting its performance.
The measured accuracy will be affected by the interference of electrosurgical equipment.
When several products are used on the same people simultaneously, danger may occur
which is arisen from the overlap of leakage current.
CO poisoning will appear excessive estimation, so it is not recommended to use the device.
This device is not intended for treatment.
The intended operator of the device may be a user.
Avoid maintaining the device during using.
The device should be operated by medical personnel via professional training,or
non-medical personnel who have been guided.
1 Overview
The oxygen saturation is the percentage of HbO
2
in the total Hb in the blood, so-called the O
2
concentration in the blood, it is an important physiological parameter for the respiratory and
circulatory system. A number of diseases related to respiratory system may cause the
decrease of SpO
2
in 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
users' SpO
2
is of great help for the doctor to discover the potential danger, and is of great
importance in the clinical medical field.
Insert the finger when measuring, the device will directly record the SpO
2
value measured, it
has higher accuracy and repeatability.
1.1 Features
A. Easy to use.
B. Small in volume, light in weight, convenient to carry.
C. Low power consumption.
1.2 Indication for Use
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, oxygen bar, 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.
1.3 Environment requirements
Storage Environment
a) Temperature: -40
℃
~+60
℃
b) Relative humidity:
≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Tempe5
℃
~+40
℃
b) Relative Humidity:
≤
90%
c) Atmospheric pressure: 700hPa~1060hPa
1.4 Precautions
1.4.1 Attention
Point out conditions or practices that may cause damage to the device or other
properties.
Before using the device, make sure that it locates in normal working state and operating
environment.
In order to get a more accurate measurement, it should be used in a quiet and
comfortable environment.
When the device is carried from cold environment to warm or humid environment,
please do not use it immediately, wait four hours at least is recommended.
If some unknown error appears during measuring, press button to reset it.
If the device is splashed or coagulated by water, please stop operating.
DO NOT operate the device with sharp things.
High temperature, high pressure, gas sterilizing or immersion disinfection for the device
is not permitted. Refer to User Manual in the relative chapter (6.1) for cleaning and
disinfection. Please set the device to standby mode before cleaning and disinfecting.
The device is suitable for children and adult.
The device may not be suitable for all users, if you can't get a satisfactory result, please
stop using it.
During measuring, when abnormal conditions appear, please pull out your finger and
reinsert it to measure again.
Data averaging and signal processing have a delay in the upgrade of SpO
2
data values.
When the data update period is less than 30 seconds, the time for obtaining dynamic
average values will increase, which is arisen from signal degradation, low perfusion or
other interference, it depends on the PR value.
The device has 3-year service life, date of manufacture: see the label.
The device does not provide over-limit alarm function for SpO
2
and PR, so it is
inapplicable for using in the place where need such function.
The maximum temperature at the SpO2 probe -tissue interface should be less than 41
℃
which is measured by the temperature tester.
Do not contort or drag the wire of the device.
The plethysmographic waveform is not normalized, as a signal inadequacy indicator,
when it is not smooth and stable, the accuracy of the measured value may degrade.
When it tends to be smooth and stable, the measured value read is the optimal and the
waveform at this time is also the most standard.
The device can not be used during charging.
If necessary, please visit our official website to get the information about SpO
2
probe
that can be used with this device.
If the device or component is intended for single-use, then the repeated use of these
parts will pose risks on the parameters and technical parameters of the equipment known
to the manufacturer.
If necessary, our company can provide some information (such as circuit diagrams,
component lists, illustrations, etc.), so that the qualified technical personnel of the user
can repair the device components designated by our company.
The measured results will be influenced by the external colouring agent (such as nail
polish, colouring agent or color skin care products, etc.), so don't use them on the test
site.
As to the fingers which are too cold or too thin or whose fingernail is too long, it may
affect the measured results, so please insert the thicker finger such as thumb or middle
finger deeply enough into the probe when measuring.
The finger should be placed correctly (see Attached figure 3), as improper installation or
improper contact position for sensor will influence the measurement.
The light between the photoelectric receiving tube and the light-emitting tube of the
device must pass through the subject’s arteriole. Make sure the optical path is free from
any optical obstacles like rubberized fabric, to avoid inaccurate results.
Excessive ambient light may affect the measured results, such as surgical light
(especially xenon light sources), bilirubin lamp, fluorescent lamp, infrared heater and
direct sunlight, etc. In order to prevent interference from ambient light, make sure to
place the sensor properly and cover the sensor with opaque material.
Frequent movement (active or passive) of the subject or severe activity can affect the
measured accuracy.
The SpO
2
probe should not be placed on a limb with the blood pressure cuff, arterial
ductus or intraluminal tube.
The measured value may be inaccurate during defibrillation and in a short period after
defibrillation, as it has not defibrillation function.
The device has been calibrated before leaving factory.
The device is calibrated to display functional oxygen saturation.
The equipment connected with the Oximeter interface should comply with the
requirements of IEC 60601-
Please select medical power adapter to charge it, when connecting the special adapter
with the socket, make sure there is no shelter near the socket and it is easy to plug and
unplug, otherwise the power will not be cut off in time when necessary, causes damage.
1.4.2 Clinical restriction
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 SpO
2
waveform
(PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
B. The measurement will be influenced by intravascular staining agents (such as indocyanine
green or methylene blue), skin pigmentation.
C. The measured value may be normal seemingly for the tester who has anemia or
dysfunctional hemoglobin(such as carboxyhaemoglobin (COHb), methaemoglobin (MetHb)
and sulfhaemoglobin (SuHb)), but the tester may appear hypoxia, it is recommended to
perform further assessment according the clinical situations and symptoms.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some severe
anemia users still show better pulse oxygen measured valued.
E. Contraindication: no
2 Principle
Figure 1 Operating 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 (HbO
2
) 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.
3 Functions
a.
Low-battery indication: low-battery indication appears when the battery voltage is
too low to work.
b.
Automatic standby function.
c.
Memory function.
d.
The data measured can be upload to the terminal equipment by wireless mode.
e.
Charging function.
4 Installation
4.1 Appearance
Figure 2 Appearance
USB interface: connect with USB cable or SpO
2
probe
Button: exit/enter the standby mode.
4.2 Installation of SpO
2
probe
Open the USB plug of the device, then insert the SpO
2
probe interface into the USB
port of the device.
4.3 Connection of USB cable
Open the USB plug of the device, insert the micro end into the interface of the device,
the other end to the power adapter.
4.4 Structure and accessories and software description
A. Structure: main unit, SpO
2
probe, USB cable, power adapter (optional) and
Bluetooth adapter (optional).
B. Accessories: one SpO
2
probe, one USB cable, one power adapter (optional), one
User Manual, Bluetooth adapter (optional).
Please check the device and accessories according to the list to avoid that the device
can not work normally.
C.Software description
Software name: CMS50S embedded software
Software specification: no
Release version: 2.0
Naming rule for version: V <Major enhancive software upgrade>.<Minor enhancive
software upgrade>.<Improvement software upgrade>
Involved algorithm: name: plethysmography; type: mature arithmetic
Purpose: be used to measure SpO
2
, pulse rate, etc.
Clinical function: calculate SpO
2
and pulse rate values by collecting and processing
the testee’ s pulse signal,
5 Operating
5.1 Measurement
A. Insert the finger into the probe as shown in Figure 3.
Figure 3 Sketch map for finger placement
(The appearance of actual probe may be different with the one shown as Figure 3,
please refer to the actual probe.)
Note: when inserting the finger, the light emitting from the sensor must be
directly irradiated to the side of the fingernail.
Note: during measuring, do not shake the finger and keep quiet, not move.
A.
Long press the Button to exit the standby mode.
B.
The device measures and saves the data automatically, the data need to be
uploaded to PC for checking.
Note: please synchronize the time with the master device when using it for the
first time, refer to chapter 5.5 for relative operations.
5.2 Exit/enter standby mode
a.
Under the standby state, long press the Button to exit from it.
b.
Under non-memory state, long press the Button to enter the standby mode.
c.
If the device has not stored data, it will automatically enter standby mode after 30
s; Button operation, Bluetooth communication and device charging can reset the
standby time.
5.3 Insufficient storage time
The device will prompt by LED when the memory space is full, memory space is not
enough to store 8 hours or battery power is not enough to test 8 hours. Refer to
section 5.7 for LED status.
