Finecare Analyzer

Name: Finecare Analyzer - Amaris Medical Solutions
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The Finecare Analyzer is a Class II medical device (FDA-cleared, CE-marked) fluorescence immunoassay system manufactured by Wondfo Biotech for quantitative detection of cardiac markers (troponin I, CK-MB, myoglobin), inflammatory markers (CRP, procalcitonin), thyroid hormones (TSH, FT3, FT4), diabetes markers (HbA1c), reproductive hormones (LH, FSH, prolactin), tumor markers (AFP, CEA, PSA), and infectious disease markers. Features include time-resolved fluorescence technology, color touchscreen interface, built-in printer (select models), USB/Ethernet connectivity, and internal rechargeable battery for portable use. Test time 3-15 minutes, sample volume 50-100 µL (whole blood, serum, plasma). Primary clinical applications include rapid diagnosis of acute myocardial infarction in chest pain patients, early detection of sepsis and bacterial infections, thyroid disorder diagnosis and monitoring, long-term glycemic control assessment in diabetes, fertility and reproductive health evaluation, cancer screening and surveillance, and infectious disease testing in endemic and clinical settings. Critical safety precautions include proper test cartridge storage (2-8°C), regular quality control, biohazard safety protocols, and operator training. Essential point-of-care testing system for hospitals, clinics, and remote healthcare facilities requiring rapid, quantitative results.

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Categories: DIAGNOSTIC EQUIPMENT, Analyzers, Diagnostic Kits, LABORATORY EQUIPMENT AND SUPPLIES Tags: Cardiac Markers, Fine care Analyzer, Fluorescence Immunoassay, HbA1c, PCT, Point Of Care Testing, Thyroid Testing, Troponin, Tumor Markers, Wondfo

Description

Finecare Analyzer

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Quantitative Detection of Cardiac Markers:

Primary Use: The Finecare Analyzer is a fluorescence immunoassay system used for quantitative measurement of cardiac markers including troponin I (cTnI), CK-MB, and myoglobin in human serum, plasma, or whole blood, enabling rapid diagnosis of acute myocardial infarction and risk stratification in patients presenting with chest pain.
How it helps: Provides emergency physicians with rapid, lab-quality cardiac test results at the bedside, confirming or ruling out heart attacks in minutes so patients receive appropriate care without delay.

2. Inflammation and Sepsis Marker Assessment:

Primary Use: Used to measure procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6 (IL-6) for early detection and monitoring of bacterial infections, sepsis, and systemic inflammatory response syndrome (SIRS) in critically ill patients.
How it helps: Gives intensive care teams early warning of sepsis, allowing them to start antibiotics and other treatments before patients deteriorate, potentially saving lives.

3. Thyroid Function Testing:

Primary Use: Provides quantitative measurement of thyroid-stimulating hormone (TSH), free T3 (FT3), and free T4 (FT4) for diagnosis and monitoring of thyroid disorders including hypothyroidism, hyperthyroidism, and thyroiditis.
How it helps: Helps patients and their doctors understand whether fatigue, weight changes, or mood symptoms are caused by thyroid problems, guiding hormone replacement or suppression therapy.

4. Diabetes Management and Monitoring:

Primary Use: Used for quantitative measurement of hemoglobin A1c (HbA1c) for long-term glycemic control assessment in diabetic patients, enabling treatment adjustments and monitoring of diabetes management effectiveness.
How it helps: Provides diabetics and their healthcare providers with a clear picture of blood sugar control over the past three months, guiding treatment decisions that can prevent devastating complications.

5. Hormone and Reproductive Health Testing:

Primary Use: Measures hormones including luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin (PRL), progesterone, and testosterone for evaluation of fertility issues, menstrual disorders, and endocrine abnormalities.
How it helps: Supports individuals and couples on their journey to parenthood by providing essential hormone data that helps fertility specialists diagnose and treat underlying causes of infertility.

6. Tumor Marker Quantification:

Primary Use: Used for quantitative detection of tumor markers including alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), prostate-specific antigen (PSA), and CA-125 for cancer screening, treatment monitoring, and recurrence surveillance.
How it helps: Helps oncologists track how well cancer treatments are working and monitor for signs of recurrence, providing valuable information that guides ongoing cancer care.

7. Infectious Disease Testing:

Primary Use: Measures specific antibodies or antigens for infectious diseases including dengue, malaria, and hepatitis, providing rapid quantitative results for patient management in endemic and clinical settings.
How it helps: Provides rapid diagnosis of tropical and infectious diseases in areas where they are most common, allowing for prompt treatment and preventing further spread.

SECONDARY & SUPPORTIVE USES

1. Therapeutic Drug Monitoring: Used to measure drug levels in patients on specific medications requiring close monitoring, ensuring therapeutic effectiveness and preventing toxicity.

2. Nutritional Status Assessment: Measures vitamin D, ferritin, and other nutritional markers for assessment of deficiencies, guiding supplementation and dietary interventions.

3. Autoimmune Disease Markers: Quantitative measurement of autoimmune markers for conditions such as rheumatoid arthritis and lupus, aiding in diagnosis and monitoring.

4. Renal Function Assessment: Measurement of cystatin C and other renal markers for kidney disease evaluation, helping detect and monitor kidney problems.

5. Bone Metabolism Markers: Assessment of markers such as vitamin D and PTH for bone health and metabolic bone disease, supporting management of osteoporosis and other bone conditions.

6. Research and Clinical Trials: Used in research settings for quantitative measurement of various analytes in clinical studies, contributing to medical advances.

7. Point-of-Care Testing in Remote Settings: Portable design enables testing in physician offices, community clinics, and remote healthcare facilities, bringing advanced diagnostic capability to underserved areas.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Product Type: Fluorescence immunoassay analyzer for quantitative detection of various clinical biomarkers.
Common Names: Finecare Analyzer, Finecare FIA Meter, Fluorescence Immunoassay Analyzer, Point-of-Care Testing System.
Manufacturer: Wondfo Biotech (Guangzhou Wondfo Biotech Co., Ltd.).
Measurement Principle: Fluorescence immunoassay (FIA) using europium chelate-labeled detection antibodies.
Sample Types: Whole blood (venous or fingerstick), serum, or plasma.
Test Time: 3-15 minutes depending on parameter.
Throughput: Up to 30-60 tests per hour depending on model.
Display: High-resolution color touchscreen (4.3-7 inches depending on model).
Connectivity: USB, Ethernet, and optional Wi-Fi for data transfer and LIS/HIS integration.
Power Source: AC adapter (100-240V) with internal rechargeable battery for portable use.

2. TECHNICAL & PERFORMANCE PROPERTIES

Measurement Method: Time-resolved fluorescence immunoassay.
Detection Sensitivity: pg/mL range for most analytes.
Linearity: High correlation (R² >0.99) with reference methods.
Precision: CV <10% for most assays.
Calibration: Factory calibrated; QC required with each test cartridge.
Test Cartridges: Single-use, disposable cartridges containing all reagents for specific tests.
Onboard Memory: Stores up to 10,000 test results with date, time, and patient ID.
Quality Control: Built-in system controls; external controls available.
Language Options: Multi-language interface.

3. PHYSICAL & OPERATIONAL PROPERTIES

Dimensions: 200-250 mm × 200-250 mm × 150-200 mm (varies by model).
Weight: 2-4 kg (portable).
Display: 4.3-7 inch color touchscreen with intuitive interface.
Printer: Built-in thermal printer on some models; external printer option.
Ports: USB, Ethernet, RS-232.
Barcode Reader: Optional integrated or external barcode scanner.
Operating Temperature: 10-30°C.
Operating Humidity: 10-80% non-condensing.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical device requiring FDA 510(k) clearance; CE marked for IVD use.
Quality Standards: Manufactured under ISO 13485.
Electrical Safety: Compliant with IEC 60601-1.
EMC Compliance: IEC 60601-1-2.
Biocompatibility: Test cartridges meet ISO 10993 for blood contact.
Data Security: Compliant with relevant data protection regulations.
Calibration: Factory calibrated; field calibration not required.
Quality Control: Built-in system checks; external controls available.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store analyzer in clean, dry environment at 10-30°C; protect from dust and direct sunlight.
Test Cartridge Storage: Store at 2-8°C (refrigerated); some cartridges may have different storage requirements.
Sample Handling: Test fresh samples within 4 hours; refrigerate if delayed.
Cleaning: Wipe exterior with soft, damp cloth; use approved disinfectant wipes.
Calibration Verification: Run quality control materials per laboratory protocol.
Battery Maintenance: Keep battery charged for portable use; replace as needed.
Software Updates: Install manufacturer updates as available.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Quantitative measurement of cardiac markers, inflammatory markers, thyroid hormones, diabetes markers, reproductive hormones, tumor markers, and infectious disease markers using fluorescence immunoassay technology.
Test Menu (varies by region and cartridge availability):
- Cardiac: Troponin I, CK-MB, Myoglobin, NT-proBNP, D-dimer.
- Inflammation: CRP, Procalcitonin (PCT), IL-6, SAA.
- Thyroid: TSH, FT3, FT4, T3, T4.
- Diabetes: HbA1c, Microalbumin, Glucose.
- Hormones: LH, FSH, PRL, Progesterone, Testosterone, β-hCG.
- Tumor Markers: AFP, CEA, PSA, CA-125, CA-19-9.
- Infectious Diseases: Dengue NS1, Dengue IgG/IgM, Malaria, Hepatitis B/C.
- Nutritional: Vitamin D, Ferritin, Folate, Vitamin B12.
- Renal: Cystatin C, Microalbumin, Creatinine.
Sample Volume: 50-100 µL typically.
Quality Control: Run controls with each new lot of test cartridges and as required by laboratory protocol.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Electrical Safety: Use only supplied power adapter; protect from liquid spills.
Biohazard Safety: All samples potentially infectious; wear appropriate PPE.
Test Cartridge Handling: Do not use expired cartridges; allow to reach room temperature before use.
Quality Control: Regular QC essential for valid results.
Cleaning: Do not immerse analyzers; use approved cleaning agents.
Calibration: Factory calibrated; do not attempt field calibration.
Data Backup: Regularly export or backup stored results.
Training: Operators should be trained on proper use and QC procedures.

2. FIRST AID MEASURES

Sample Spill: Contain with absorbent material; disinfect area with 10% bleach solution.
Eye Contact with Sample or Reagents: Flush with copious water for 15 minutes; seek medical attention.
Electrical Malfunction: Disconnect power; do not use until serviced.
Needlestick Injury (if using lancets): Wash area vigorously with soap and water; report immediately.

3. FIRE FIGHTING MEASURES

Flammability: Plastic components and reagents are combustible.
Extinguishing Media: For electrical fire, use CO₂ or dry chemical (Class C) extinguisher.
Power Off: Disconnect power if safe to do so.

Finecare Analyzer

Finecare Analyzer

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Quantitative Detection of Cardiac Markers:

How it helps: Provides emergency physicians with rapid, lab-quality cardiac test results at the bedside, confirming or ruling out heart attacks in minutes so patients receive appropriate care without delay.

2. Inflammation and Sepsis Marker Assessment:

Primary Use: Used to measure procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6 (IL-6) for early detection and monitoring of bacterial infections, sepsis, and systemic inflammatory response syndrome (SIRS) in critically ill patients.

How it helps: Gives intensive care teams early warning of sepsis, allowing them to start antibiotics and other treatments before patients deteriorate, potentially saving lives.

3. Thyroid Function Testing:

Primary Use: Provides quantitative measurement of thyroid-stimulating hormone (TSH), free T3 (FT3), and free T4 (FT4) for diagnosis and monitoring of thyroid disorders including hypothyroidism, hyperthyroidism, and thyroiditis.

How it helps: Helps patients and their doctors understand whether fatigue, weight changes, or mood symptoms are caused by thyroid problems, guiding hormone replacement or suppression therapy.

4. Diabetes Management and Monitoring:

Primary Use: Used for quantitative measurement of hemoglobin A1c (HbA1c) for long-term glycemic control assessment in diabetic patients, enabling treatment adjustments and monitoring of diabetes management effectiveness.

How it helps: Provides diabetics and their healthcare providers with a clear picture of blood sugar control over the past three months, guiding treatment decisions that can prevent devastating complications.

5. Hormone and Reproductive Health Testing:

Primary Use: Measures hormones including luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin (PRL), progesterone, and testosterone for evaluation of fertility issues, menstrual disorders, and endocrine abnormalities.

How it helps: Supports individuals and couples on their journey to parenthood by providing essential hormone data that helps fertility specialists diagnose and treat underlying causes of infertility.

6. Tumor Marker Quantification:

Primary Use: Used for quantitative detection of tumor markers including alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), prostate-specific antigen (PSA), and CA-125 for cancer screening, treatment monitoring, and recurrence surveillance.

How it helps: Helps oncologists track how well cancer treatments are working and monitor for signs of recurrence, providing valuable information that guides ongoing cancer care.

7. Infectious Disease Testing:

Primary Use: Measures specific antibodies or antigens for infectious diseases including dengue, malaria, and hepatitis, providing rapid quantitative results for patient management in endemic and clinical settings.

How it helps: Provides rapid diagnosis of tropical and infectious diseases in areas where they are most common, allowing for prompt treatment and preventing further spread.

SECONDARY & SUPPORTIVE USES

1. Therapeutic Drug Monitoring: Used to measure drug levels in patients on specific medications requiring close monitoring, ensuring therapeutic effectiveness and preventing toxicity.

2. Nutritional Status Assessment: Measures vitamin D, ferritin, and other nutritional markers for assessment of deficiencies, guiding supplementation and dietary interventions.

3. Autoimmune Disease Markers: Quantitative measurement of autoimmune markers for conditions such as rheumatoid arthritis and lupus, aiding in diagnosis and monitoring.

4. Renal Function Assessment: Measurement of cystatin C and other renal markers for kidney disease evaluation, helping detect and monitor kidney problems.

5. Bone Metabolism Markers: Assessment of markers such as vitamin D and PTH for bone health and metabolic bone disease, supporting management of osteoporosis and other bone conditions.

6. Research and Clinical Trials: Used in research settings for quantitative measurement of various analytes in clinical studies, contributing to medical advances.

7. Point-of-Care Testing in Remote Settings: Portable design enables testing in physician offices, community clinics, and remote healthcare facilities, bringing advanced diagnostic capability to underserved areas.

1. BASIC IDENTIFICATION ATTRIBUTES

Product Type: Fluorescence immunoassay analyzer for quantitative detection of various clinical biomarkers.

Common Names: Finecare Analyzer, Finecare FIA Meter, Fluorescence Immunoassay Analyzer, Point-of-Care Testing System.

Manufacturer: Wondfo Biotech (Guangzhou Wondfo Biotech Co., Ltd.).

Measurement Principle: Fluorescence immunoassay (FIA) using europium chelate-labeled detection antibodies.

Sample Types: Whole blood (venous or fingerstick), serum, or plasma.

Test Time: 3-15 minutes depending on parameter.

Throughput: Up to 30-60 tests per hour depending on model.

Display: High-resolution color touchscreen (4.3-7 inches depending on model).

Connectivity: USB, Ethernet, and optional Wi-Fi for data transfer and LIS/HIS integration.

Power Source: AC adapter (100-240V) with internal rechargeable battery for portable use.

2. TECHNICAL & PERFORMANCE PROPERTIES

Measurement Method: Time-resolved fluorescence immunoassay.

Detection Sensitivity: pg/mL range for most analytes.

Linearity: High correlation (R² >0.99) with reference methods.

Precision: CV <10% for most assays.

Calibration: Factory calibrated; QC required with each test cartridge.

Test Cartridges: Single-use, disposable cartridges containing all reagents for specific tests.

Onboard Memory: Stores up to 10,000 test results with date, time, and patient ID.

Quality Control: Built-in system controls; external controls available.

Language Options: Multi-language interface.

3. PHYSICAL & OPERATIONAL PROPERTIES

Dimensions: 200-250 mm × 200-250 mm × 150-200 mm (varies by model).

Weight: 2-4 kg (portable).

Display: 4.3-7 inch color touchscreen with intuitive interface.

Printer: Built-in thermal printer on some models; external printer option.

Ports: USB, Ethernet, RS-232.

Barcode Reader: Optional integrated or external barcode scanner.

Operating Temperature: 10-30°C.

Operating Humidity: 10-80% non-condensing.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical device requiring FDA 510(k) clearance; CE marked for IVD use.

Quality Standards: Manufactured under ISO 13485.

Electrical Safety: Compliant with IEC 60601-1.

EMC Compliance: IEC 60601-1-2.

Biocompatibility: Test cartridges meet ISO 10993 for blood contact.

Data Security: Compliant with relevant data protection regulations.

Calibration: Factory calibrated; field calibration not required.

Quality Control: Built-in system checks; external controls available.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store analyzer in clean, dry environment at 10-30°C; protect from dust and direct sunlight.

Test Cartridge Storage: Store at 2-8°C (refrigerated); some cartridges may have different storage requirements.

Sample Handling: Test fresh samples within 4 hours; refrigerate if delayed.

Cleaning: Wipe exterior with soft, damp cloth; use approved disinfectant wipes.

Calibration Verification: Run quality control materials per laboratory protocol.

Battery Maintenance: Keep battery charged for portable use; replace as needed.

Software Updates: Install manufacturer updates as available.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Quantitative measurement of cardiac markers, inflammatory markers, thyroid hormones, diabetes markers, reproductive hormones, tumor markers, and infectious disease markers using fluorescence immunoassay technology.