AccuMed AC-CMS-50DL Fingertip Pulse Oximeter User Manual

AccuMed AC-CMS-50DL Fingertip Pulse Oximeter

Instructions to User

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. 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 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 abnormalities, 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.

Due to continual renovation, the specific products you received may not be totally in accordance with the description of this User Manual. We would sincerely apologize for this. This product is a medical device, which can be used repeatedly.

WARNING:

• An uncomfortable or painful feeling may appear 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 special patients, there should be a more prudent inspection in the placing process.
• The device cannot 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.
• Testee cannot use enamel or other makeup.
• Testee’s fingernail cannot 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 patient’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 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 accessories that are recommended by the manufacturer can be used with this device.
• This product is calibrated before leaving the

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 and
• People who are allergic to rubber cannot use this
• The disposal of scrap instruments, 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 totally in accordance with the packing list, or else the device may have the possibility of working
• Please don’t measure this device with function test paper for the device’s related

Attention

• Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperatures, and moisture.
• If the oximeter gets wet, please stop using 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.
• Do not have the oximeter immersed in liquid. When it needs cleaning, please wipe its surface with medical alcohol on soft material. Do not spray any liquid on the device directly.
• When cleaning the device with water, the temperature should be lower than 60ºC.
• 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 a 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, 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 device has a normal life span of three years since its first electrified use.
• The hanging rope attached to the product is made from non-allergy material. If particular groups 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 to avoid causing harm to the patient.
• 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.
• When the parameter is specified, 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.

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 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.

The Pulse Oximeter features in small size, low power consumption, convenient operation, and portability. It is only necessary for patients to put one of their fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show the measured value of Hemoglobin Saturation

Classification:

Class II b(MDD93/42/EEC IX Rule 10)

Features

• Operation of the product is simple and
• The product is small in size, 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
• Low battery indicator as battery icon will flash when the battery is

Major applications and scope of application

The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through the finger and indicate the pulse intensity by the bar display. The product is suitable for use in families, hospitals (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 the continuous supervision of patients.
• 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

1. Temperature: -40ºC~+60ºC
2. Relative humidity: ≤95%
3. Atmospheric pressure: 500hPa~1060hPa

Operating Environment

1. Temperature: 10ºC~40ºC
2. Relative Humidity: ≤75%
3. Atmospheric pressure: 700hPa~1060hPa

Principle

Principle of measurement

The principle of the Oximeter is as follows: An experience formula of data processing is established by making use of Lambert-Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) 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 a microprocessor

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 therebetween．
3. The SpO2 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
5. Excessive ambient light may affect the measuring result. It includes a fluorescent lamp, dual ruby light, infrared heater, direct sunlight, etc.
6. Strenuous action of the subject or extreme electrosurgical interference may also affect the
7. Testee cannot use enamel or other

Clinical restrictions

1. As the measurement is taken on the basis of arteriole pulse, 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 SpO2 waveform (PLETH) will 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), methionine (Me+Hb), or thiosalicylic hemoglobin, and some with icterus problem, the SpO2 determination by this monitor may be
3. The drugs like dopamine, procaine, prilocaine, lidocaine, and butacaine may also be a major factor blamed for serious errors in SpO2
4. As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO2

Technical

• Display Format: Digital tube Display;
• SpO 2 Measuring Range: 0% – 100%;
• Pulse Rate Measuring Range: 30 bpm – 250 bpm;
• Pulse Intensity Display: columniation display
• Power Requirements: 2 ×1.5V AAA alkaline batteries (or using the rechargeable battery instead), adaptable range: 2.6V~3.6V.
• Power Consumption: Lower than 25
• Resolution: 1% for SpO2 and 1 bpm for Pulse
• Measurement Accuracy: ±2% in the stage of 70%-100% SpO2, and meaningless when the stage is smaller than 70%. ±2 bpm or±2% (select larger) for Pulse Rate.
• Measurement Performance in Weak Filling Condition: SpO2 and pulse rate can be shown correctly when the pulse-filling ratio is 0.4%. The SpO2 error is ±4%, pulse rate error is ±2 bpm or ±2% (select larger).
• 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%.
• It is equipped with a function switch. The Oximeter can be powered off in case no finger is in the Oximeter for 5 seconds.
• 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. Refer to Figure 3 and insert the two AAA-size batteries in the right direction.
2. Replace the cover.

Please take care when you insert the batteries as 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

• Insert the two batteries in the correct direction, and then replace the cover.
• Open the clip as shown in Figure 5. Figure 5. Put a finger in the position
• Put 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.
• Press the switch button once on the front panel.
• Do not shake the finger and keep the patient at ease during the process. It is not recommended for the patient to be moving.
• Get the information directly from the screen display.
• In the boot-strap state, press the button, and the device is reset. The fingernail and screen should be on the same side.

Repairing and Maintenance

• Please change the batteries when 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 a dry clean fabric.
• Use medical alcohol to disinfect the product after use to prevent cross-infection the next time it is used.
• Please take out the batteries if the oximeter is not in use for a long period of time.
• The best storage environment for the device is – 40ºC to 60ºC ambient temperature and no higher than 95% relative humidity.
• 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. Do not immerse the device in liquid. It is recommended that the device should be kept in a dry environment. Humidity may reduce the life span of the device, or even damage it.

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 correctly.

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. Keep the patient calm and at rest.

The device cannot be turned on

| 1. The batteries are dead or almost dead.

2. The batteries are not inserted properly.

3. The device is defective.

| 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.

|
---|---|---|---

Key of Symbols

Function Specification

Display Information| Display Mode|
---|---|---
The Pulse Oxygen Saturation(SpO2)| Digital|
Pulse Rate(BPM)| Digital|
Pulse Intensity (bar-graph)| Digital bar-graph display|
SpO 2 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 indicates a stronger pulse.|
Battery Requirement|
1.5V (AAA size) alkaline batteries × 2 or rechargeable batteries|
Battery Useful Life|
Two batteries can work continuously for 24 hours|
Dimensions and Weight|
Dimensions| 57(L) × 31(W) × 32(H) mm|
Weight| About 50g (with the batteries)|

Frequently Asked Questions

Is the Accumed pulse oximeter accurate?

It reads accurate oxygen saturation and pulse rate in one device. The Pulse Oximeter fits all finger sizes from kids above four years old to adults as it measures the level of oxygen in the blood and reads the pulse rate in just eight to ten seconds.

How do you use an Accumed pulse oximeter?

Remove the back cover and install the two AAA batteries included in the box. Insert your finger by aligning it with the red light and wait for the oximeter to switch on. Read the results in eight to ten seconds.

What is the battery life of a pulse oximeter?

The oximeter uses two 1.5 V AAA-type batteries and a set of new batteries can be used for more than 18 hours, depending on the concrete battery type.

How long should the oximeter stay on the finger?

It works best on the middle or index finger of either hand, it should not be used on your ear. The reading takes time to steady. Keep the pulse oximeter in place for at least a minute, or longer if the reading keeps changing. Record the highest result once the reading has not changed for five seconds.

Can the oximeter show the wrong reading?

Pulse oximeters have limitations and risks of inaccuracy under certain circumstances. In many cases, the level of inaccuracy may be small and not clinically meaningful; however, there is a risk that an inaccurate measurement may result in unrecognized low oxygen saturation levels.

Is the AccuMed oximeter FDA-approved?

The LED display cover prevents ambient light washout, making readings crisp and clear. FDA registered. Other information: 1-year US Warranty provided exclusively through AccuMed.

How does a fingertip oximeter work?

The pulse oximeter uses a cold light source that shines a light through the fingertip, making the tip appear to be red. By analyzing the light from the light source that passes through the finger, the device is able to determine the percentage of oxygen in the red blood cell.

Do different fingers give different oximeter readings?

According to the results of our study, we believe that the middle finger of the dominant hand has the highest and possibly the most accurate SpO2 measurements. The highest SpO2 value can be taken as the most accurate value that reflects the arterial oxygen saturation (SaO2).

Does dark skin affect pulse oximetry?

Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender.

Can an oximeter detect COVID?

We do not recommend using a pulse oximeter as a way to tell if someone has COVID-19. Get tested if you have signs of COVID-19 or if you have been close to someone who has it. If someone has COVID-19, a pulse oximeter may help them keep watch over their health and to know if they need medical care.

Does the oximeter show the correct oxygen level?

A pulse oximeter is used at home to watch for changes in oxygen levels. Your doctor may suggest using one if you have a condition that affects your oxygen level. Your test results and changes in your symptoms are used together to check your health and make decisions.

Which sensor is used in the pulse oximeter?

Conventional pulse oximeters non-invasively measure human pulse rate and arterial blood oxygen saturation with an optoelectronic sensor composed of two inorganic light-emitting diodes (LEDs) with different peak emission wavelengths and a single inorganic photodiode

What are the principles of pulse oximetry?

Pulse oximetry is based on two physical principles: (a) the presence of a pulsatile signal generated by arterial blood, which is relatively independent of non-pulsatile arterial blood, venous and capillary blood, and other tissues; and (b) the fact that oxyhemoglobin (O2Hb) and reduced hemoglobin (Hb) have different

Does sunlight affect the pulse oximeter?

Pulse oximeter readings are not significantly affected by 5 light sources commonly found in the clinical setting.

How do you maintain a pulse oximeter?

(Cleaning) Wipe the outer surfaces, sensors, and cables of the device from top to bottom with a cloth or disposable wipe soaked in detergent and clean water, and then wipe off any remaining detergent residue with a dry lint-free cloth. To avoid permanent damage, do not use excessive amounts of liquids to clean the device.

Video – Overview

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