CONTEC CMS50M LED Pulse Oximeter

Instructions to User

Dear users, thank you very much for purchasing the 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, the main structure, functions, specifications, and 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 User Manual carefully before using this product. The User Manual which describes the operating procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality, equipment damage, and human injury. The manufacturer is NOT responsible for the safety, reliability, and performance issues and any monitoring abnormality, human injury, and equipment damage due to users’ negligence of the operating 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 that. This product can be used repeatedly. The operating life is 3 years. If you have any questions regarding to the use of this product, please call us at 1-847-562-1702 Monday-Friday from 8:00 AM to 5:00 PM Eastern Time.
WARNING
The uncomfortable or painful feeling may appear if using the device cea~elessly, especially for microcirculation barrier users. It is
recommended that the sensor should not be applied to the same finger for over 2 hours.

• For special users, there should be a more prudent inspection 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 should not stare at the light.
• Users can not use enamel or other makeup.
• The user’s fingernail can not be too long.
• Please refer to the correlative literature about clinical restrictions and caution.
• This device is not intended for treatment.

The User Manual is published by our company. All rights reserved.

Safety

Instructions for Safe Operations

• Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect the user’s safety and monitor the performance of 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 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 is appointed or recommendatory by the manufacturer can be used with this device.
• This product is calibrated before leaving the factory.

Warnings

• Explosive hazard-DO NOT use the oximeter in an environment with inflammable gas such as some ignitable anesthetic agents.
• A person who is allergic to rubber can not use this device.
• The disposal of scrap instruments and their accessories and packing (including batteries, plastic bags, foams, and paper boxes) should follow 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 my 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.

Attention

• 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 a cold environment to a warm or humid environment, please do not use it immediately.
• DO NOT operate keys on the 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 on cleaning and disinfection.
• Does not have the oximeter immersed 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°C.
• As to the fingers which are too thin or too cold, it would probably affect the normal measure of the users’ Sp02 and pulse rate, please clip the thick finger such as the thumb and middle finger deeply enough into the probe.
• Do not use the device on infant or neonatal users.
• The product is suitable for adults(Weight should be between 40kg and to 1IOkg).
• 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 rates.
• If some abnormal conditions appear on the screen during the test process, pull out the finger and reinsert it to restore normal use.
• The hanging rope attached to the product is made from Non- allergic material, if the particular group is 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 to avoid causing harm to the users.
• The instrument does not have a 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 particular, The instrument does not have an 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.

Indication for Use

The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial hemoglobin(Sp02) and the pulse rate of adults in home-use environments. This device is not intended for continuous monitoring. The device can be multi-used. Solely for use in sporting and aviation activities. Intended to monitor heart rate during exercise.

Overview

The pulse oxygen saturation is the percentage of HbOz in the total Hb in the blood, so-called the Oz concentration in the blood. It is an important bio-parameter for respiration. For the purpose of measuring the SpOz more easily and accurately, our 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 is portable. It is only necessary for the user to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show the measured value of Hemoglobin Saturation.

Features

• The 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.
• The power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for 24 hours.
• The product will automatically be powered off when no signal is in the product within 5 seconds.
• Low – battery indicator as battery icon flash manner.

Major Applications and Scope application

The Pulse Oximeter can be used in measuring pulse oxygen saturation and pulse rate through the 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 sports).
Warning: The problem of overrating would emerge when the user is suffering from toxicosis caused by carbon monoxide, the device is not recommended to he used under these circumstances.

Environment Requirements

Storage Environment

• Temperature: -40 C + 60 C
• Relative humidity: 95%
• Atmospheric pressure: 500hPa-1060hPa

Operating Environment

• Temperature: 10 C – 40 C
• Relative Humidity: S75%
• Atmospheric pressure: 700hPa-1060hPa

Principle and Caution

Principle of Measurement

The 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 (HbOz) in glow & near-infrared zones. The 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 wavelengths of light can be focused onto a human nail tip through a 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 microprocessors.

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 SpOz sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position therebetween.
3. The SpOz sensor should not be used at a location or limb tied with an arterial canal or blood pressure cuff or receiving an 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 lamps ~ 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. Users can not use enamel or other makeup.

Clinical Restrictions

1. As the measure is taken on the basis of arteriole pulse, the substantial pulsating blood flow of the subject is required. For a subject with a weak pulse due to shock, low ambient body temperature, major bleeding, or use of the vascular contracting drug, the SpOz 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 drugs (such as methylene blue, indigo green, and acid indigo blue), or carbon monoxide hemoglobin (COHb), methionine (Me+Hb) or this salicylic hemoglobin, and some with icterus problems, the SpOz 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 errors in SpOz measure.
4. As the SpOz value serves as a reference value for judgment of anemic anoxia and toxic anoxia~ some users with serious anemia may also report good SpOz measurement.

Technical Specifications

1. Display Format: Digital tube Display;
   SpO2 Measuring Range: 0% – 100%;
   Pulse Rate Measuring Range: 30 bpm – 250 bpm;
   Pulse Intensity Display: columniation display
2. Power Requirements: 2 x 1.5V AAA alkaline battery, adaptable range: 2.6V-3.6V.
3. Power Consumption: Smaller than 25 RNA.
4. Resolution: 1% for SpOz and 1 bpm for Pulse Rate.
5. Measurement Accuracy: ±2% in the stage of 70%-100% SpOz, and meaningless when the stage is smaller than 70%. ±2 bpm or±2% (select larger) for
   Pulse Rate. Clinical Trial: SpOz regression plot & Bland-Altman plot, Refer to Figure 2 & Figure 3.
6. Measurement Performance in Weak Filling Condition: SpOz and pulse rate can be shown correctly when the 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, indoor natural light, and that of
   darkroom is less than ±l %.
8. It is equipped with a switch function. The Oxirpeter can be powered off when the finger is off the oximeter within 5 seconds.
9. Optical Sensor
   Red light (wavelength is 660nm, 6.65mW)
   Infrared (wavelength is 880nm, 6.75mW)
   

Accessories

• One hanging rope
• Two batteries (optional)
• One User Manual

Installation

View of the Front Panel

Battery

• Step 1. Insert the two AAA-size batteries properly in the right direction.
• Step 2. Put on the cover.
  Please take care when you insert the batteries for improper insertion may damage the device.

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.

Operating Guide

1. Insert the two batteries properly to the direction, and then put the cover.
2. Open the clip.
3. Let the user’s finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then! clip the finger. As shown in Figure 5
   
4. Press the switch button once on the front panel.
5. Do not shake the finger and keep the user at ease during the process. Meanwhile, the human body is not recommended in movement status.
6. Get the information directly from the screen display.
7. In the boot-strap state, press the button, and the device is reset.
   Fingernails and the luminescent tube should be on the same side.

Repairing and Maintenance

• Please change the batteries when the low-voltage is displayed on the screen.
• Please clean the surface of the device before using it. Wipe the device with medical alcohol first, and then let it dry in the air or clean it with dry clean fabric.
• Using medical alcohol to disinfect the product after use, to prevent cross infection for next time use.
• Please take out the batteries if the oximeter is not in use for a long time.
• The packed device can be transported by ordinary conveyance or according to the transport contract. The device can not be transported mixed with toxic,
  harmful, corrosive material.
• The best storage environment of the device is – 40°C to 60°C ambient temperature and not higher than 95% relative humidity. Users are advised to calibrate the device termly (or according to the calibrating program of the hospital). It also can be performed by the state-appointed agent or just contact us for calibration.

Warning:

• 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.

Troubleshooting

Key of Symbols

Function Specification

Appendix

Guidance and manufacture’s declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity – for aU EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEMfor EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING

FAQs

References

• User Manual