Contec CMS50DL User Manual

CMS50DL 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 support:+86-335-8015431
E-mail: cms@contecmed.com.cn
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: shholding@hotmail.com
CMS2.782.028(CE.USA)ESS/2.1 1.4.01.01.703 2021.02
Instructions to User
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. 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.
 Do NOT strand the lanyard to avoid device drop and damage. The lanyard is made
of insensitive material. Please do not use it if any person is allergic to lanyard. Do
not wrap the lanyard around neck to avoid an accident.
 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.
 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.
 Functional testers can not be used to assess the accuracy of the 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.
 The measured accuracy will be affected by the interference of electrosurgical equipment.
 When several products are used on the same patient 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 patient.
 Avoid maintaining the device during using.
1 Overview
The oxygen saturation is the percentage of HbO 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 in the blood, furthermore, some other causes such as the malfunction of
2
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' SpO is of great help for the doctor to discover the potential danger, and is of great
2
importance in the clinical medical field.
Insert the finger when measuring, the device will directly display the SpO
2
has a 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 Applied range
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate
through finger, and indicate the pulse intensity by the bar-display. The product is suitable for
use in family, hospital(Ordinary sickroom ), Oxygen Bar, social medical organizations and
also the measure of saturation oxygen and pulse rate.
1.3 Environment requirements
Storage Environment
a) Temperature: -40 ℃ ~ + 60 ℃
b) Relative humidity: ≤ 95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: +10 ℃~ + 40 ℃
b) Relative Humidity: ≤ 75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
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 it is carried from cold environment to warm or humid environment, please do not
use it immediately.

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 take out the internal battery before cleaning and disinfection.

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.

Data averaging and signal processing have a delay in the upgrade of SpO
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 hasn't low-voltage prompt function, it only shows the low-voltage, please
change the battery when the battery voltage is used up.

The maximum temperature at the SpO probe -tissue interface should be less than 41℃
2
which is measured by the temperature tester.

During measuring, when abnormal conditions appear on the screen, please pull out your
finger and reinsert it to measure again.

If some unknown error appears during measuring, remove the battery to terminate
operating.

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.

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 5), 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
2
measured accuracy.

The Pulse Oximeter 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 60601-1.
value measured, it 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
(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 patients 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
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
photosensitive element, information acquired through which will be shown on screen through
treatment in electronic circuits and microprocessor.
3 Functions
A. SpO value display
2
B. PR value and bar graph display
data values.
2
C. Low-battery indication: low-battery indication appears when the battery voltage is too low
to work
D. Automatic standby function
4 Installation
4.1 View of the front panel
Figure 2. Front View
4.2 Battery
Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right
direction.
Step 2. Replace the cover.
Please take care when you insert the batteries for the improper insertion may
damage the device.
4.3 Mounting the hanging rope
Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the first one and then tighten it.
waveform 4.4 Structure, accessories and software description
2
A. Structure: main unit.
B. Accessories: one User Manual, one hanging rope.
Please check the device and accessories according to the list to avoid that the
device can not work normally.
C. Software description
Software name: CMS50DL embedded software
Software specification: no
Release version: V2.0
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
Clinical function: calculate SpO
testee' s pulse signal.
5 Operating Guide
5.1 Insert the two batteries properly to the direction, and then replace the
cover.
5.2 Open the clip as shown in Figure 5.
) in glow & near-infrared zones.
2
measured signal can be obtained by a
5.3 Let the patient's finger put into the rubber cushions of the clip (make sure
the finger is in the right position), and then clip the finger.
5.4 Press the button once on front panel.
5.5 Do not shake the finger and keep the patient at ease during the process.Meanwhile,
human body is not recommended in movement status.
5.6 Get the information directly from screen display.
5.7 In boot-strap state,press button ,and the device is reset.
Fingernails and the luminescent tube should be on the same side.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must be turned off before cleaning, and it should not be immersed into
liquid.
Please take out the internal battery before cleaning, do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, and use liquid soap or isopropanol to
wipe the watchband for disinfection, nature dry or clean it with clean and soft cloth. Do
not spray any liquid on the device directly, and avoid liquid penetrating into the device.
6.2 Maintenance
A. 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. It is
recommended that the device should be inspected weekly at least. When there is obvious
damage, stop using it.
B. Please clean and disinfect the device before/after using it according to the User
Manual (6.1).
Figure 3. Batteries Installation
Figure 4. Mounting the hanging rope.
, pulse rate, etc.
2
and pulse rate values by collecting and processing the
2
Figure 5. Put finger in position