Contec CMS50DA User Manual

CMS50DA User Manual
P u l s e O x i m e t e r
Contec Medical Systems Co., Ltd.
＆ Technical
Address:No.112 Qinhuang West Street, Economic
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
CMS2.782.027(ZD)(OCH)ESS
Instructions to User
Dear Users, thank you very much for purchasing our product.
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 Manual very carefully before using this equipment. These
instructions describe the operating procedures to be followed strictly, failure to
follow these instructions can cause measuring abnormality, equipment damage
and personal injury. The manufacturer is NOT responsible for the safety,
reliability and performance issues and any monitoring abnormality, personal
injury and equipment damage due to user's 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 can be used repeatedly. Its using life is 3 years.
If you have any questions regarding to the use of this product, please call us at
1-847-979-9008 Monday-Friday from 8:00 AM to 5:00 PM Eastern Time.
WARNING:
 The uncomfortable or painful feeling may appear if using the device
ceaselessly, especially for the microcirculation barrier users. It is
recommended that the sensor should not be applied to the same finger
for over 2 hours.
 For the individual users, there should be a more prudent inspecting in
the placing process. The device can not be clipped on the edema and
tender tissue.
 The light (the infrared is invisible) emitted from the device is harmful
to the eyes, so the user and the maintenance man, can not stare at the
light.
 User can not use enamel or other makeup.
 User's fingernail can not be too long.
 Please peruse the relative content about the clinical restrictions and
caution.
 This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
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 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 Warnings
 Explosive hazard—DO NOT use the oximeter in environment with
inflammable gas such as some ignitable anesthetic agents.
 The person who is allergic to rubber can not use this device.
 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 don't measure this device with function test paper for the device's
related information.
 Parts of the device that are not serviced or maintained while in use with the
user.
 Warning against servicing and maintenance while the me equipment is in
use.
 No modification of this equipment is allowed.
 The user is an intended operator.
 The probe of the device is the applied part.
1.3 Attentions
 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 for 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 users' SpO and pulse rate, please clip the thick finger
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such as thumb and middle finger deeply enough into the probe.
 Do not use the device on infant or neonatal user.
 The product is suitable for adults (Weight should be between 40 kg to 110 kg).
 The device may not work for all users. If you are unable to achieve stable
readings, discontinue use.
 The update period of data is less than 5 seconds, which is changeable according
to different individual pulse rate.
 The waveform is normalized.Please read the measured value when the
waveform on screen is equably and steady-going, Here this measured value is
optimal value. And the waveform at the moment 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 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
attention to the use of the hanging rope , do not wear it around the neck avoiding
cause harm to the user.
 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.
 When the parameter is particularly, The instrument dose not have alarm
function.Do not use the device in situations where alarms are required.
 Batteries must be removed if the device is going to be stored for more than one
month, or else batteries may leak.
 A flexible circuit connects the two parts of the device. Do not twist or pull on
the connection.
1.4.Indication for Use
The Pulse Oximeter is a non-invasive device intended for the spot-check of
saturation of arterial hemoglobin(SpO ) and the pulse rate of adult in home use
2
environments.This device is not intended for continuous monitoring.The device can
be multi-used.Solely for use with sporting and aviation activities.Intended to monitor
heart rate during exercise.
2 Overview
The pulse oxygen saturation is the percentage of HbO in the total Hb in the blood,
2
so-called the O concentration in the blood. It is an important bio-parameter for the
2
respiration. For the purpose of measuring the SpO more easily and accurately, our
2
company developed the Pulse Oximeter. At the same time, the device can measure
the pulse rate simultaneously.
The Pulse Oximeter features in small volume, low power consumption, convenient
operation and being portable. It is only necessary for user to put one of his fingers
into a fingertip photoelectric sensor for diagnosis, and a display screen will directly
show measured value of Hemoglobin Saturation.
2.1 Features

Operation of the product is simple and convenient.

The product is small in volume, light in weight (total weight is about 50g
including batteries) and convenient in carrying.

Power consumption of the product is low and the two originally equipped AAA
batteries can be operated continuously for 20 hours.

The product will automatically be powered off when no signal is in the product
within 5 seconds.

The product will enter standby mode when no signal is in the product within 5
seconds.

Display direction can be changed automatically,easy to view.
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used in measuring pulse oxygen saturation and pulse rate
through finger. The product is suitable for family use(It can be used before or after
doing sports, and it is not recommended to use the device during the process of
doing sport) .
The problem of overrating would emerge when the user 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: ≤95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: 10 ℃ ~ 40 ℃
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700 hP a~ 1060 hPa
3 Principle and Caution
3.1 Principle of Measurement
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
& near-infrared zones. Operation principle of the instrument 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 Operating principle
3.2 Caution
1. The finger should be placed properly (see the attached illustration of this
manual, Figure 7), or else it may cause inaccurate measurement.
2. The SpO sensor and photoelectric receiving tube should be arranged in a way
2
with the subject's arteriole in a position there between．
3. The SpO sensor should not be used at a location or limb tied with arterial canal
2
or blood pressure cuff or receiving intravenous injection.
4. Make sure the optical path is free from any optical obstacles like rubberized
fabric.
5. Excessive ambient light may affect the measuring result. It includes fluorescent
lamp, dual ruby light, infrared heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electrosurgical interference may also
affect the accuracy.
7. User can not use enamel or other makeup.
3.3 Clinical Restrictions
1. 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 waveform (PLETH) will decrease. In this case, the measurement
2
will be more sensitive 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 SpO determination by this monitor may be inaccurate.
2
3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may
also be a major factor blamed for serious error of SpO
4. As the SpO value serves as a reference value for judgement of anemic anoxia
2
and toxic anoxia, some users with serious anemia may also report good SpO
measurement.
4 Technical Specifications
1) Display Format: LCD Display;
SpO Measuring Range: 0% ~ 100%;
2
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
2) Power Requirements: 2× 1.5 V AAA alkaline battery (or using the
rechargeable battery instead), adaptable range: 2.6 V - 3.6 V.
3) Power Consumption: Smaller than 30 mA.
4) Resolution: 1% for SpO and 1 bpm for Pulse Rate.
2
5) Measurement Accuracy: ± 2% in stage of 70% - 100% SpO
when stage being smaller than 70%. ± 2 bpm during the pulse rate range of 30 -
99 bpm and ± 2% during the pulse rate range of 100 ~ 250 bpm . Clinical
Trial :SpO regression plot & Bland–Altman plot,Refer to Figure 2 & Figure 3.
2
6) Measurement Performance in Weak Filling Condition: SpO
can be shown correctly when pulse-filling ratio is 0.4%. SpO
pulse rate error is ± 2 bpm during the pulse rate range of 30 ~ 99 bpm and ± 2%
during the pulse rate range of 100 ~ 250 bpm .
7) Resistance to surrounding light: The deviation between the value measured in
the condition of man-made light or indoor natural light and darkroom is less
than ± 1%.
8) It is equipped with a function switch: The product will enter standby mode
when no signal is in the product within 5 seconds.
9) Optical Sensor
Red light (wavelength is 660 nm, 6.65 mW)
Infrared (wavelength is 880 nm, 6.75 mW)
) in glow
2
Figure 2 SpO regression plot
2
Figure 3 Bland–Altman plot
5 Accessories

One hanging rope;

Two batteries(optional)

One User Manual.
6 Installation
6.1 View of the Front Panel
Figure 4 Front view
measure.
2
2
, and meaningless Figure 5 Batteries installation
2
6.2 Battery
Step 1. Refer to Figure 5. and insert the two AAA size batteries properly in the
and pulse rate right direction.
2
error is ± 4%, Step 2. Put back the cover.
2
Please take care when you insert the batteries for the improper
insertion may damage the device.
6.3 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 6 Mounting the hanging rope