User's Manual

CMS50DL1 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: [phone]
Fax: [phone]
Technical support:[phone]
E-mail: [e-mail]
Website: http://www.contecmed.com
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
CMS2.782.179(CE.USA)ESS/1.9 1.4.01.01.701 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
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
patients' 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 display the SpO
2
value measured, it
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
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 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
2
probe -tissue interface should be less than 41℃
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
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.
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 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
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. SpO
2
value display
B. PR value and bar graph display
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 3-1 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.
Sketch map for the back cover in ON/OFF state refer to Figure 3-2:
Figure 3-1 Batteries Installation Figure 3-2 Installation for the Back Cover
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.
Figure 4. Mounting the hanging rope.
4.4 Structure, accessories and software description
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
2
, pulse rate, etc.
Clinical function: calculate SpO
2
and pulse rate values by collecting and processing
the 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.
Figure 5. Put finger in position
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.