URIT Medical Electronic PFS-30A - User Manual

URIT
PFS-30/PFS-30A
Blood Lipid Analyzer
OPERATION MANUAL
URIT Medical Electronic Co., Ltd.

Summary

Warnings

Operating Instructions

Installation and Change of Batteries

Step-by-step guide for installing and replacing the AAA batteries in the analyzer.

Buttons

Describes the functions and operation modes (short press, press and hold) of the analyzer's buttons.

Display Information

CHD Risk Evaluation Function

Code

Procedure for inserting the code card to match test strips for accurate readings.

Detection of Blood Lipid

Detailed steps for performing blood lipid tests, including preparation, sampling, and detection.

Cautions!

Important safety notes and precautions to be followed during the blood lipid detection process.

Management of Saving Data

Errors & Troubleshooting

Maintenance & Care of analyzer

Technical Paraanalyzers

Overview

1. Function Description
2. Usage Features
3. Operational Workflow
4. Maintenance Features
5. Safety Warnings

The URIT PFS-30/PFS-30A Blood Lipid Analyzer is a medical device designed for the quantitative detection of various blood lipid parameters in human whole blood samples. This analyzer is intended for use by both lay persons and healthcare professionals, making it suitable for daily blood lipid detection in individuals with normal or abnormal blood lipid levels. However, it is not suitable for neonatal testing, and its results should not be used for the sole diagnosis of cardiovascular diseases. The device operates based on reflection photometry, utilizing a built-in microcomputer to control and measure blood lipid content.

Function Description

The primary function of the PFS-30/PFS-30A Blood Lipid Analyzer is to measure total cholesterol (TC), high-density lipoprotein cholesterol (HDL), triglyceride (TG), and low-density lipoprotein cholesterol (LDL) in human whole blood (venous or capillary blood) samples. Additionally, it calculates ratios such as TC/HDL based on these measurements. The analyzer is designed to work exclusively with the corresponding PFS 30 Blood Lipid Test Strips produced by URIT.

The measurement process involves inserting a test strip into the analyzer, which then automatically obtains a blank value. Once prompted, the operator applies a blood sample to the test area of the strip. Chemicals generated by the interaction of the blood sample and the test strip produce an absorption spectrum near 630nm wavelength, altering the optical reflection coefficient of the thin film on the test hole. The analyzer introduces light into the test zone and detects the intensity of the reflected light. A lower detected light intensity indicates a higher concentration of the detected substance, and vice versa. The internal computer then automatically calculates the blood lipid concentration based on the relationship between reflected light intensity and substance concentration, displaying the result on the LCD screen.

The analyzer also includes a CHD (Coronary Heart Disease) risk evaluation function, which can be initiated after successful detection. It offers two evaluation methods: FRA (Framingham CHD Risk Evaluation) and PRO (Procam CHD Risk Evaluation). The FRA method is used for evaluating CHD risk in the next 10 years for males or females aged 30 to 79 years old, while the PRO method is for males aged 35 to 75 years old. To perform a CHD risk evaluation, users input patient history details such as gender, age, smoking history, systolic blood pressure, and medical history for hypertension treatment. The analyzer then calculates and displays the CHD risk percentage.

Usage Features

The URIT PFS-30/PFS-30A analyzer is designed for user-friendly operation with several key features:

• LCD Display: Provides clear operating information and test results.
• Buttons: The device has multiple buttons:
  • (On/OFF Button): Used to turn the analyzer on/off, select items, or confirm selections.
  • M Button: Initiates the inquiry screen and other operating functions when the analyzer is off. Also used to decrease numbers during settings or navigate through results.
  • S Button: Initiates the setting screen and other operating functions when the analyzer is off. Also used to increase numbers during settings or navigate through results.
• Code Card Slot: For inserting the code card that matches the blood lipid test strip batch, ensuring accurate measurements. The analyzer automatically reads the code card upon startup.
• Test Strip Slot: Where the test strip is inserted for detection.
• Battery Cover: Secures the batteries.
• Data Communication and Printer Connector: A universal connector for connecting the analyzer to a computer for data communication or to a portable printer for printing test results.
• Bluetooth Function (PFS-30 only): Allows direct transfer of test data to connected devices like cellphones and tablets.

Operational Workflow:

1. Preparation: Gather the analyzer, test strips, lancing device, lancet, and swab.
2. Battery Installation: The analyzer uses 3 AAA batteries. Ensure correct insertion, with the negative pole inserted first. The analyzer automatically powers off after 5 minutes of inactivity to conserve power. Batteries should be removed if the analyzer will not be used for an extended period.
3. Settings: Before detection, users can access a settings screen by pressing and holding the S button when the analyzer is off. This allows for setting the date and time, enabling/disabling the CHD risk evaluation function, and selecting the measurement unit (mg/dL or mmol/L). The date and time are crucial for accurate record-keeping and are automatically displayed for adjustment if batteries are replaced.
4. Code Setting: Insert the matched code card from the test strip box into the code card slot. The analyzer will automatically read the code and display it. It is critical to verify that the displayed code matches the code on the test strip package.
5. Blood Sampling: Thoroughly wash and dry hands. Disinfect the finger tip with ethanol. Do not use iodine or iodine-containing disinfectants. Use a lancing device and lancet according to their instructions to collect 35-40µL of blood.
6. Test Strip Insertion: Turn on the analyzer. When the "Test Strip Indicator" flashes, insert a test strip. Wait for the "Sampling Indicator" to flash before applying the blood sample to the center of the test area. Do not touch the test area with the blood sampling device.
7. Detection: Once sufficient blood is applied, the "Sampling Indicator" will stop flashing, and "---" will be displayed, indicating that the 120-second detection process has begun.
8. Result Display: After detection, the TC concentration will be displayed first. Users can press the M or S button to view results for HDL, TG, TC/HDL, and LDL.
9. Data Management: The analyzer can store up to 300 test results. When the memory is full, the oldest record is automatically deleted to make space for new data. Users can inquire about saved data by pressing the M button when the analyzer is off, then using M or S buttons to scroll through records.
10. Printing: If a printer is connected, pressing and holding the M button on the "Review Test Result" screen will print the results.
11. Data Deletion: All saved data can be deleted by pressing and holding both S and M buttons simultaneously when the analyzer is off, after initiating the data deletion procedure by pressing and holding the M button. This action is irreversible.

Maintenance Features

Proper maintenance is essential for ensuring the accuracy and longevity of the URIT PFS-30/PFS-30A Blood Lipid Analyzer:

• Cleaning Contamination: If the analyzer is accidentally contaminated with blood, it should be cleaned immediately. Use a wet cotton swab or soft flannel to carefully wipe the contaminated parts.
• Cleaning Test Strip Connector: If excessive blood is applied during sampling, the test strip connector should be cleaned. Soak gauze in an appropriate detergent and use it to clean the connector or any residual blood on the outer casing.
• Cleaning Optical Detection Module: The optical detection module should be cleaned with a wet cotton swab and a small amount of detergent if contaminated by excess blood. Afterward, wipe it dry with a cotton cloth that contains no yarn. The surrounding area near the test strip connector should also be cleaned.
• Avoiding Damage: Do not allow liquid to penetrate the analyzer. Avoid abrasion on the surface of the optical detection module. Do not use strong abrasive or corrosive detergents, as these can damage the analyzer and its optical detection module.
• Storage: If the analyzer will not be used for a long time (e.g., 1 month), remove the batteries. Store the analyzer and its accessories in a place with a temperature between -20°C and 50°C and relative humidity below 90%. Keep it away from heat sources or radiative sources.
• Disposal of Medical Waste: Used test strips and lancets are contaminated with blood samples and should be disposed of as medical waste following standard procedures. Used gloves and swabs should also be placed in special waste containers.
• Environmental Conditions: The analyzer should be used within an environment temperature range of 15°C to 35°C. Using it outside this range may result in "TEP" error.
• Battery Replacement: The analyzer indicates low battery capacity with a symbol, prompting operators to replace batteries.

Safety Warnings:

Users must read the operation manual thoroughly before using the analyzer to prevent damage to the device or inaccurate results. Incorrect use can lead to fire or burns. The device is for external monitoring only and not for diagnosis. Always use the correct code card and test strips provided or recommended by the manufacturer. Do not disassemble the analyzer. Keep it away from children and pets. Avoid high temperature, humid environments, and contact with dust, salt, or sulfur. Do not immerse the analyzer in liquid or place it where it might fall into liquid. Do not place anything on top of the device or use it where aerosol droplets are present. Do not touch surfaces that are too hot. Avoid touching the sample area of the test strip. Do not use damaged or stained test strips or expired test strips. Do not press or move the analyzer or test strip during testing. Avoid direct exposure to strong light. Do not drop anything into the device's openings other than the test strip. The device complies with EN 61326-2-6-2013 and IEC 61010-1-2010 standards. Avoid using it near strong electromagnetic radiation sources. In medical institutions, evaluate the electromagnetic environment before use. Static discharges from synthetic materials can cause erroneous results. Venous blood tests should be performed by medical personnel following relevant operating rules. During detection, avoid touching buttons or the machine body. Wear protective gloves when handling blood samples. Ensure sufficient blood volume is applied the first time; do not reapply.

URIT Medical Electronic PFS-30A Specifications

General

Brand	URIT Medical Electronic
Model	PFS-30A
Category	Measuring Instruments
Language	English