PROFICARE PC-PO 3104 Pulse Oximeter Instruction Manual

: June 3, 2024
: PROFICARE

PROFICARE PC-PO 3104 Pulse Oximeter

Instructions to User

Thank you for choosing our product.

We hope you will enjoy using the appliance. This instruction 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 instruction 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 instruction manual. We would sincerely regret for that. This product is medical device, and can be used repeatedly. Its using life is 3 years. The use of this Pulse Oximeter is not intended as a substitute for consultation with your physician. Please consult your physician if you have any doubts about the readings. The readings of the Pulse Oximeter are to be considered as guide values. Do not attempt to do any self-diagnosis or self-treatment based on the readings. Please seek professional medical advice if necessary.

Warning

The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation barrier persons. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
For the individual persons, 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, should not stare at the light.
The test person can not use nail polish or other makeup (e. g. artificial fingernails or nail jewellery).
The test person fingernail can not be too long.
Please peruse the relative content about the clinical restrictions and caution.
This device is not intended for treatment.

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 test person’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 Pulse Oximeter cannot be used together with devices not specified in this instruction manual. Only the accessory that appointed or recommendatory by manufacture can be used with this device.
This product is calibrated before leaving factory.

Warnings

Explosive hazard – DO NOT use the Pulse Oximeter in environment with inflammable gas such as some ignitable anesthetic agents.
DO NOT use the Pulse Oximeter while the test person 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.

Attention

Keep the Pulse Oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
If the Pulse 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 Pulse Oximeter is not permitted. Refer to the instruction manual in the relative chapter for instructions of cleaning and disinfection.
Do not have the Pulse 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 °C.
As to the fingers which are too thin or too cold, it would probably affect the normal measure of the persons’ 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 adults.
The device may not work for all persons. 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 instrument dose not have low-voltage alarm function, it only shows the low-voltage. Please change the batteries when the battery energy is used out.
When the parameter is particularly, the instrument does 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.

Intended Purpose

The Pulse Oximeter can be used for measuring the arterial oxygen saturation and pulse rate through the finger. The product is suitable for being used in family, hospital, oxygen bar, community healthcare, physical care in sports (it can be used before or after doing sports, and it is not recommended to use the device during the process of having sport) and etc.

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. The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for the user to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and the display screen will directly show measured value of Haemoglobin Saturation.

Classification

Class a, (MDD93 / 42 / EEC IX Rule 10)

Features

Operation of the product is simple and convenient.
The product is small in volume, light in weight (total weight is about 50 g including batteries) and convenient in carrying.
The appliance’s power consumption is low and, depending on the AAA batteries that are inserted, the appliance can be operated continuously for up to 20 hours.
The device will enter standby mode when no measure accrue within 5 seconds.
The display direction can be changed automatically for an easy reading.

Major Applications and Scope of Application

The Pulse Oximeter can be used to measure human Haemoglobin 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 persons.
The problem of overrating would emerge when the test person is suffering from toxicosis which caused by carbon monoxide, the device is not recommended to be used under this circumstance.

Environment Requirements

Storage Environment

Temperature: −40 °C ~ +60 °C
Relative humidity: ≤95 %
Atmospheric pressure: 500 hPa ~ 1060 hPa

Operating Environment

Temperature: 10 °C ~ 40 °C
Relative Humidity: ≤75 %
Atmospheric pressure: 700 hPa ~ 1060 hPa

Principle and Caution

Principle of Measurement

PROFICARE-PC-PO-3104-Pulse-Oximeter-fig-1

Principle of the Pulse 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 Haemoglobin (Hb) and Oxyhemoglobin (HbO2) in visible & 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 the measured signal can be obtained by a photosensitive element, the information acquired through which will be shown on screen through treatment in electronic circuits and microprocessors.

Caution

The finger should be placed properly (as shown in the figure in the chapter “Operating Guide” in this instruction manual), or else it may cause inaccurate measurement.
The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the test person’s arteriole in a position there between.
The SpO2 sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection.
Make sure the optical path is free from any optical obstacles like rubberised fabric.
Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc.
Strenuous action of the subject or extreme electro-surgical interference may also affect the accuracy.
The test person can not use nail polish or other makeup (e. g. artificial fingernails or nail jewellery).

Clinical Restrictions

As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of the test person is required. For a person 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.
For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or carbon monoxide haemoglobin (COHb), or methionine (Met+Hb) or thiosalicylic haemoglobin, and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.
The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for serious error of SpO2 measure.
As the SpO2 value serves as a reference value for judgement of anaemic anoxia and toxic anoxia, some persons with serious anaemia may also report good SpO2 measurement.

Technical Specifications

Product name: Pulse Oximeter
Model: PC-PO 3104 (PO6)
Display Format: LCD Display;
SpO2 Measuring Range: 0 % ~ 100 %;
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm;
Perfusion Index Measuring Range: 0 % ~ 20 %;
Pulse Wave Display: Columniation display and the waveform display.
Power Requirements: 2 × 1.5 V AAA alkaline battery (or using rechargeable batteries instead), adaptable range: 2.6 V – 3.6 V.
Power Consumption: Smaller than 30 mA.
Resolution: 1 % for SpO2 and 1 bpm Pulse Rate.
Perfusion Index: 0.1 %.
Measurement Accuracy: ±2 % in stage of 70 % ~ 100 % SpO2, and meaningless when stage being smaller than 70 %. ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2 % during the pulse rate range of 100 bpm ~ 250 bpm.
Measurement Performance in Weak Filling Condition: SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4 %. SpO2 error is ±4 %, pulse rate error is ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2 % during the pulse rate range of 100 bpm ~ 250 bpm.
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 %.
It is equipped with a function switch: The product will enter standby mode when no signal is in the product within 5 seconds.
Optical Sensor
Red light (wavelength is 660 nm, 6.65 mW)
Infrared (wavelength is 880 nm, 6.75 mW)

Accessories

Storage bag
Instruction manual

Installation

View of the Front Panel

The display SpO2
Perfusion Index (only shown in one display direction)
Pulse rate
Waveform (only shown in one display direction)
Battery voltage indicator
Pulse rate bar graph

Insert the Batteries (not included in scope of delivery)

Step 1: See illustration opposite.
- Insert 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.

Operating Guide

Open the clip as shown in the figure below.
Slide a finger between the rubber pads of the clip as shown (make sure the finger is in the correct position), and then close the clip.
Press the button once on front panel.
Keep your finger still and do not move during the measurement process. Movements during the measurement are not recommended as they may affect the result.
Get the information directly from screen display.
The button has two functions.
- When the device is in standby mode, pressing the button can exit the standby mode.
- When the device is in operation status, pressing the button long can change brightness of the screen.
The device could change display direction according to the handing direction.

Fingernail and emission tube should be on the same side.

Repairing and Maintenance

Please change the batteries when the low battery symbol is 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 Pulse Oximeter is not in use for a long time.
The best storage environment of the device is −40 ºC to 60 ºC 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 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

PROFICARE-PC-PO-3104-Pulse-Oximeter-fig-5

Key of Symbols

PROFICARE-PC-PO-3104-Pulse-Oximeter-fig-6

Function Specification

EMC

Table 1

Table 2

Table 3

Table 4

PROFICARE-PC-PO-3104-Pulse-Oximeter-fig-12

Warning

Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Active medical devices are subject to special EMC precautions and they must be installed and used in accordance with these guidelines.

Note: When the device is disturbed, the data measured may fluctuate, please measure repeatedly or in another environment to ensure its accuracy.