Contec CMS50D1 Bruksanvisning
Contec
Pulsoximetrar
CMS50D1
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Instructions to User
Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical
devices and harmonized standards. The Manual is written for the current Pulse Oximeter. 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 is medical device, and can be used repeatedly. Its using life is 3 years.
WARNING:
The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the
microcirculation barrier patients. It is recommended that the sensor should not be applied to the
same finger for over 2 hours.
For the individual patients, 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.
Testee can not use enamel or other makeup.
Testee’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 patient’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
monitor.
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.
DO NOT use the oximeter while the testee measured by MRI and CT.
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.
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
patients' SpO2 and pulse rate, please clip the thick finger such as thumb and middle finger deeply enough
into the probe.
Do not use the device on infant or neonatal patients.
The product is suitable for children above four years old and adults(Weight should be between 15kg to
110kg).
The device may not work for all patients. 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 device has normal useful life for three years since the first electrified 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 patient.
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.
2 Overview
The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2
concentration in the blood. It is an important bio-parameter for the respiration. For the purpose of measuring the
SpO2 more easily and accurately, our company developed the Pulse Oximeter. At the same time, the device can
measure the pulse rate simultaneously.
I
The Pulse Oximeter features in small volume, low power consumption, convenient operation and being
portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for
diagnosis, and a display screen will directly show measured value of SpO
2.
2.1 Classification:
Class II b(MDD93/42/EEC IX Rule 10)
Class II (U.S.FDA)
2.2 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.
2.3 Major Applications and Scope of Application
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.
The product is not suitable for use in continuous supervision for patients.
The problem of overrating would emerge when the patient is suffering from toxicosis which
caused by carbon monoxide, the device is not recommended to be used under this
circumstance.
2.4 Environment Requirements
Storage Environment
a) Temperature :-40 ~+60℃ ℃
b) Relative humidity : 95%≤
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature:10 ~40℃ ℃
b) Relative Humidity : 75%≤
c) Atmospheric pressure:700hPa~1060hPa
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 (HbO2) in glow & 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 5), or else it may cause
inaccurate measurement.
2. The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a
position there between.
3. The SpO
2 sensor should not be used at a location or limb tied with arterial canal 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. Testee 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 SpO2 waveform (PLETH) will decrease. In this case, the measurement 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 SpO2 determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for
serious error of SpO2 measure.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients
with serious anemia may also report good SpO2 measurement.
4 Technical Specifications
1. OLED Display;Display Format:
SpO2
Measuring Range: 0% - 100%;
Pulse Rate Measuring Range: 30 bpm - 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
2. 2 ×1.5V AAA alkaline battery(or using the rechargeable battery instead),Power Requirements:
adaptable range: 2.6V~3.6V.
3. Power Consumption: Smaller than 30mA.
4. 1% for SpOResolution: 2 and 1 bpm for Pulse Rate.
5. ±2% in stage of 70%-100% SpOMeasurement Accuracy: 2, and meaningless when stage being smaller
than 70%. ±2 bpm or±2% (select larger) for Pulse Rate.
6. Measurement Performance in Weak Filling Condition: SpO
2 and pulse rate can be shown correctly
when pulse-filling ratio is 0.4%. SpO2 error is ±4%, pulse rate error is ±2 bpm or ±2% (select larger).
7. Resistance to surrounding light: The deviation between the value measured in the condition of man-
made light or indoor natural light and that of darkroom is less than ±1%.
8. It is equipped with a function switch. The Oximeter can be powered off in case no finger is the Oximeter
within 5 seconds.
9. Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
5 Accessories
One hanging rope;
Two batteries (optional);
One User Manual.
6 Installation
6.1 View of the Front Panel
Figure 2. Front View
6.2 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.
Figure 3.
Batteries
Installation
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 4.
Mounting
the hanging
rope
Low-battrey
indication
Pulse bar graph
Pulse
waveform
Button
SpO2 Pulse rate
II
7 Operating Guide
7.1 Insert the two batteries properly to the direction, and then replace the cover.
7.2 Open the clip as shown in Figure 5.
Figure 5. Put
finger in
position
7.3 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.
7.4 Press the switch button once on front panel.
7.5 Do not shake the finger and keep the patient at ease during the process. Meanwhile, human body is not
recommended in movement status.
7.6 Get the information directly from screen display.
7.7 The button has three
functions.When the device is
power off, pressing the button can open it; When the device is power on, pressing the
button shortly can change direction of the screen; When the device is power on,
pressing the button long can change of the screen.brightness
Fingernails and the luminescent tube should be on the same side.
8 Repairing and Maintenance
Please change the batteries when the low-voltage displayed on the screen.
Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then
let it dry in air or clean it by dry clean fabric.
Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time
use.
Please take out the batteries if the oximeter is not in use for a long time.
The best storage environment of the device is - 40ºC to 60ºC ambient temperature and not higher than
95% relative humidity.
Users are advised to calibrate the device termly (or according to the calibrating
program of hospital). It also can be performed at the state-appointed agent or jus
t contact us for calibration.
High-pressure sterilization cannot be used on the device.
Do not immerse the device in liquid.
It is recommended that the device should be kept in a dry environment. Humidity may reduce
the useful life of the device, or even damage it.
9 Troubleshooting
Trouble Possible Reason Solution
The SpO2 and Pulse
Rate can not be
displayed normally
1. The finger is not properly positioned.
2. The patient’s SpO2 is too low to be
detected.
1. Place the finger properly and try
again.
2. Try again; Go to a hospital for a
diagnosis if you are sure the device
works all right.
The SpO2 and Pulse
Rate are not displayed
stably
1. The finger is not placed inside deep
enough.
2. The finger is shaking or the patient is
moving.
1. Place the finger properly and try
again.
2. Let the patient keep calm
The device can not be
turned on
1. The batteries are drained or almost
drained.
2. The batteries are not inserted properly.
3. The malfunction of the device.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the local service
center.
The display is off
suddenly
1. The device will power off
automatically when it gets no signal
within 5 seconds.
2. The batteries are almost drained.
1. Normal.
2. Change batteries.
10 Key of Symbols
Symbol Description
Type BF
Refer to instruction manual/booklet
The pulse oxygen saturation(%)
PRbpm Pulse rate (bpm)
The battery voltage indication is deficient (change the battery in time avoiding the
inexact measure)
1. no finger inserted
2. An indicator of signal inadequacy
battery positive electrode
battery cathode
1.Power switch
2.change direction of the screen
3.Change brightness of the screen
SN Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22 Ingress of liquids rank
European Representative
This item is compliant with Medical Device Directive 93/42/EEC of June 14,
1993, a directive of the European Economic Community.
11 Function Specification
Display Information Display Mode
The Pulse Oxygen Saturation(SpO2) OLED
Pulse Rate(PR) OLED
Pulse Intensity (bar-graph) OLED bar-graph display
Pulse wave OLED
SpO2 Parameter Specification
Measuring range 0%~100%, (the resolution is 1%).
Accuracy 70%~100%: ±2% ,Below 70% unspecified.
Optical Sensor Red light (wavelength is 660nm)
Infrared (wavelength is 880nm)
Pulse Parameter Specification
Measuring range 30bpm~250bpm (the resolution is 1 bpm)
Accuracy ±2bpm or±2% select larger
Pulse Intensity
Range Continuous bar-graph display, the higher display indicate the
stronger pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 20 hours
Dimensions and Weight
Dimensions 61(L) × 36(W) × 32(H) mm
Weight About 57g (with the batteries)
Appendix
Guidance and manufacture’s declaration-electromagnetic emission
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration –electromagnetic emission
The is tended for use in the electromagnetic environmentCMS50D1 Pulse Oximeter
specified below. The customer of the user of the shouldCMS50D1 Pulse Oximeter
assure that it isused in such an environment.
Emission test compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The uses RF CMS50D1 Pulse Oximeter
energy only for their internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class B The is suitableCMS50D1 Pulse Oximeter
III
Produktspecifikationer
| Varumärke: | Contec |
| Kategori: | Pulsoximetrar |
| Modell: | CMS50D1 |
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