AccuMed CMS-50D1 Fingertip Pulse Oximeter User Manual

AccuMed CMS-50D1 Fingertip Pulse Oximeter

Thank you very much for purchasing our product! This Manual is written and compiled in accordance with the council directive MDD 93/42/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, the 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 the user’s negligence of the operating instructions. The manufacturer’s warranty service does not cover such faults. Due to continual re-innovation, the products you received may not be totally in accordance with the description of this User Manual. We would sincerely regret that. This product is a medical device and can be used repeatedly.

WARNING

• An uncomfortable or painful feeling may develop if using the device ceaselessly, especially for microcirculation barrier patients. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
• For individual patients, there should be a more prudent inspection in the measured part. The device can not be placed 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, cannot stare at the light.
• Testee can not use enamel or other makeup.
• Testee’s fingernail should 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.

Overview

The pulse 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 bio parameter for respiration. Many respiratory diseases will cause the body’s SpO 2 to decrease, while the body’s automatic adjustment disorder caused by the anesthesia, big surgery trauma, and some of the damage caused by medical examination, are likely to lead to the patient’s oxygen supply problems and reduce the body’s SpO2, resulting in patient dizziness, weakness, vomiting, and other symptoms. Severe cases will threaten life. So knowing the patient’s SpO 2 in time will help doctors which has great significance in the clinical medical area. The Pulse Oximeter features a small size, low power consumption, convenient operation, and portability. It is only necessary for the patient to put one of his fingers into a fingertip photoelectric sensor for diagnosis. A display screen will directly show the measured value of Hemoglobin Saturation.

Features

• Simple and convenient operation.
• The product is small in size , light in weight and convenient to carry
• Low power consumption.
• Major Applications and Scope of Application

The product is applicable for use in family, hospital, oxygen bar, community medical treatment, and sports health care (it is advised to be used before and after sports and it is not suggested to be used in the process of sport), etc.
Note: The product is not suitable for use in continuous supervision for patients.
Note: The problem of overrating would emerge when the patient is suffering from toxicosis which is caused by carbon monoxide. The device is not recommended to be used under this circumstance.

Environment Requirements

Storage Environment

• a) Tempe rature: 40 ºC ~+60 ºC
• b) Relative humidity: ≤
• c ) Atmospheric pressure: 500hPa~1060hPa

Operating Environment

• a) Temperature 10 ºC ~4 0ºC
• b ) Relative Humidity: ≤
• c) Atmospheric pressure: 700hPa~1060hPa

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 patient’s safety and monitoring performance. It is recommended that the device should be inspected once a week at least. When there is obvious damage, stop using it.
• 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 accessories that are recommended by the manufacturer can be used with this device.
• This product has been calibrated before leaving the factory.

Warnings

• Explosive hazard DO NOT use the oximeter in an environment with flammable gas such as some ignitable anesthetic agents.
• DO NOT use the oximeter while the testee is undergoing an MRI or CT.
• A person who is allergic to the rope cannot use this device.
• 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 the local laws and regulations.
• Please check the packing before use to make sure the device and accessories are in accordance with the packing list, or else the device may have the possibility o f working abnormally.
• Please don t measure this device with function test paper for the device s related information.

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 of cleaning and disinfection.

• Do 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 ºC

• 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 the thumb and middle finger deeply enough into the probe.

• Do not use the device on infants 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, please stop using it.

• The update period of data is less than 5 seconds, which is changeable according to different individual pulse rates.

• The waveform is normalized. Please read the measured value when the waveform on the screen is equably and steadily going. Here this measured value is the optimal value. And the waveform at the moment is the standard one.

• If some abnormal conditions appear on the screen during the test process, pull out the finger and reinsert to restore normal use.

• The device has a normal life span of three years since its first electrified use.

• The hanging rope attached to the product is made from Nonallergy material. If a 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 patient.

• The instrument doesn’t have a low-voltage alarm function. It only shows the low voltage Please change the battery when the battery is dead

• The device doesn’t have an alarm for exceeding a limit. 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.

Principle of Measurement

The principle of the Oximeter is as follows: An experience formula of the data process is established by taking use of Lambert-Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin ( Hb O 2 ) 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 measure d signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessors.

Technical Specifications

Main Performance

1. SpO 2 value display.
2. Pulse rate value, bar graph display.
3. Pulse waveform display.
4. Low battery indication: When the voltage is too low to work, the battery capacity indication appears.
5. Automatically power off function: The product will automatically be powered off when there is no signal within 5 seconds.
6. The display format can be changed.

Main Parameters

1. SpO2 Measuring
   Range: 0%~
   Accuracy: 2% in the stage of 70% 100% SpO 2, and meaningless when the stage is smaller than 70%.

2. Pulse Rate Measuring
   Range: 30 bpm 250 bpm
   Accuracy: ±2 bpm or±2% (select larger)

3. Resolution: 1% for SpO 2 and 1 bpm for Pulse Rate.

4. Resistance to surrounding light: The deviation between the value measured in the condition of man made light or indoor natural light and that of the darkroom is less than ±1%.

5. Working voltage: DC 2.6V~3.6V.

Installation

1. View of the Front Panel

Battery Installation

1. Refer to Figure 3 and insert the two AAA-size batteries properly in the right direction.

2. Replace the cover.
   Warning Please take care with the batteries as improper insertion may damage the device.

3. Mounting the Hanging Rope

4. Put the end of the rope through the hole.

5. Put another end of the rope through the first one and then tighten it

6. Accessories

7. A hanging rope;

8. Two batteries (optional)

9. A User Manual.

Operating Guide

Operation Method

1. Insert the two batteries in the proper direction, and then replace the Please take care with the batteries as improper insertion may damage the device.
2. Open the clip as shown in Figure 6.
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.
   • a. Press the switch button once on the front panel.
   • b. Do not shake the finger and keep the patient calm during the measuring process. It is recommended that the patient be resting and not moving
4. Get the information directly from the screen display.
5. In an operational state, lightly press this button to change the direction of the screen.
6. In the operational state, a long press of this button can change the brightness of the screen.
   Note: Fingernails and the screen should be on the same side.

Caution

• Before use, please fully check the device to make sure that it can work correctly.
• The finger should be placed properly ( see the attached illustration in this manual Figure 6), or else it may cause inaccurate measurement.
• The SpO 2 sensor and photoelectric receiving tube should be arranged in a way with the sub ject’s arteriole in a position there between.
• The SpO 2 sensor should not be used on a limb tied with arterial canal, blood pressure cuff or receiving intravenous injection.
• Make sure the optical path is free from any optical obstacles like rubberized fabric or else it may cause inaccurate SpO 2 and pulse rate.
• Excessive ambient light may affect the measuring result. This includes fluorescent lamps, dual ruby lights, infrared heaters, direct sunlight, etc.
• Strenuous action of the testee or extreme electrosurgical interference may also affect the accuracy.
• Testee can not use enamel or other makeup.
• After use, please refer to the respective chapters about cleaning and disinfection for details.

Clinical Restrictions

1. As the measurement is taken on the basis of arteriole pulse, substantial pulsating blood flow in 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 SpO 2 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), carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicyli c hemoglobin, and some with icterus problem, the SpO 2 determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine, and butacaine may also be major factors blamed for the serious errors in SpO2 measure.
4. As the SpO 2 value serves as a reference value for the judgment of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO 2 measurement.

Maintenance of Transportation and Storage

Cleaning and Disinfecting

After cleaning the device, wipe the surface of the device with ethanol and self-air dry (or clean with a clean, dry cloth).

Maintenance

• Before using, please refer to the respective chapters about cleaning and disinfection for details.
• Please change the batteries when the low voltage is displayed on the screen.
• Please take out the batteries if the oximeter is not in use for a long time.
• Users are advised to calibrate the device periodically (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. High-pressure sterilization cannot be used on the device.

Transportation and Storage

• The device can not be transported mixed with toxic, harmful, or corrosive material.
• The best storage environment for the device is 40ºC to 60 ºC ambient temperature and no higher than 95% relative humidity and in a room with no corrosive material and good ventilation.

Troubleshooting

The SpO 2 and Pulse Rate cannot 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 SpO 2 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 cannot be turned on

| 1. Low battery or no battery.

2. The batteries are not inserted properly.

3. The device is malfunctioning.

| 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 there is no signal within 5 seconds.

2. The batteries are almost drained.

|

1. Normal.

2. Change batteries.

Key of Symbols

Function Specification

SpO 2 Parameter **Specification
Measuring range| 0%~100%, (the resolution is 1%).
Accuracy| 70%~100%: ±2%, Below 70% unspecified.
Pulse Parameter Specification
Measuring range| 30bpm~250 bpm (the resolution is 1 bpm)
Accuracy| ±2bpm or ±2% select larger
Safety type| Internally powered equipment type: BF applied part
Pulse Intensity
Range| Continuous bar-graph display, the higher display indicates a stronger pulse.
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
1.5V,600mAh (AAA size) alkaline batteries × 2 can work continually for 32 hours
Dimensions and Weight**
Dimensions| 61(L) × 36(W) × 32(H) mm
Weight| About 60g (with the batteries)

FAQs

What are the main components of a pulse oximeter?****

The main components consist of a sensor, which looks like a small clip, and a display unit which shows you the results of the test. You attach the sensor to one finger or earlobe and then place the display unit nearby so you can see it easily.

How do I use my new Pulse Oximeter?****

Before using the Pulse Oximeter, read all instructions carefully and follow them carefully to ensure proper operation. If you have any questions about using it, please contact our customer service department at any time before or after purchase!

What is the CMS-50D1 Fingertip Pulse Oximeter from AccuMed?****

A medical device that measures both pulse rate and blood oxygen saturation level is the AccuMed CMS-50D1 Fingertip Pulse Oximeter.

What is the mechanism of the AccuMed CMS-50D1 Fingertip Pulse Oximeter?****

The AccuMed CMS-50D1 Fingertip Pulse Oximeter measures the quantity of light that passes through the fingertip after shining a light through it. Calculating the blood’s oxygen saturation level requires this information.

How reliable is the AccuMed CMS-50D1 Fingertip Pulse Oximeter?****

Yes, it is generally agreed upon that the AccuMed CMS-50D1 Fingertip Pulse Oximeter is accurate and trustworthy.

Who should use the AccuMed CMS-50D1 Fingertip Pulse Oximeter?****

Athletes, pilots, and people with respiratory problems like COPD and asthma frequently utilize the AccuMed CMS-50D1 Fingertip Pulse Oximeter.

How quickly does the AccuMed CMS-50D1 Fingertip Pulse Oximeter provide a reading?****

The AccuMed CMS-50D1 Fingertip Pulse Oximeter normally provides a reading in just a few seconds.

Is it simple to use the AccuMed CMS-50D1 Fingertip Pulse Oximeter?****

It is simple to operate the AccuMed CMS-50D1 Fingertip Pulse Oximeter. To activate it, simply place it on your fingertip and press the button.

Can children use the AccuMed CMS-50D1 Fingertip Pulse Oximeter?****

Children can use the AccuMed CMS-50D1 Fingertip Pulse Oximeter, however, the instrument needs to be suitable for the child’s size and age.

How can I clean the Fingertip Pulse Oximeter AccuMed CMS-50D1?****

With a clean, moist towel, you can clean the AccuMed CMS-50D1 Fingertip Pulse Oximeter. Before using the device once more, make careful to completely dry it.

Video – Product Overview

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