Plus Semi-Automated Urine Analyzer (CL-500)

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The Urine Analyzer Plus Semi-Automated (CL-500) is a high-throughput, semi-automated urine test strip analyzer designed for large-volume clinical laboratories, hospital settings, public health screening programs, and high-volume point-of-care facilities . Using LED reflectance photometry at 550nm, 620nm, and 720nm wavelengths, the analyzer measures up to 14 urinary parameters with a throughput of 550 strips per hour and a test time of 65 seconds .
The analyzer features automatic strip feeding for continuous loading without operator intervention, built-in onboard waste collection, and open system compatibility accepting standard urine test strips. The microprocessor-based system stores 5,000 test results with multilingual support (English, Russian, Spanish, Ukrainian), offers comprehensive connectivity (bidirectional LIS, RS-232, USB, WiFi), and includes a built-in thermal printer .
Measured parameters include leukocytes, ketone, nitrite, protein, glucose, blood, calcium, ascorbic acid, urobilinogen, bilirubin, specific gravity, microalbumin, pH, and creatinine—enabling comprehensive urinalysis for UTI diagnosis, diabetes screening, preeclampsia detection, and chronic kidney disease monitoring .
For the clinical laboratory scientist and public health program manager, the CL-500 Plus enables high-volume UTI diagnosis (550 tests/hour), population-based diabetes screening, proteinuria surveillance in large antenatal services, CKD monitoring for hypertension and diabetes programs, and integrated public health reporting via bidirectional LIS connectivity. For the patient, high-throughput urinalysis enables early detection of urinary tract infections (preventing pyelonephritis and urosepsis), timely diagnosis of diabetes and preeclampsia (reducing complications), and early identification of chronic kidney disease (preserving renal function)—particularly in large-scale screening programs where efficient testing is essential for population health impact .
Description

Plus Semi-Automated Urine Analyzer CL-500 

PRIMARY CLINICAL & DIAGNOSTIC USES

1. High-Throughput Urinary Tract Infection (UTI) Screening
  • Primary Use: Provides a high-throughput semi-automated urine test strip analyzer with automatic strip feeding (up to 550 strips per hour) using LED reflectance photometry at 550nm, 620nm, and 720nm wavelengths to detect leukocytes and nitrites as primary UTI indicators .
  • How it helps: For the clinical laboratory scientist and infectious disease specialist, the CL-500 Plus delivers high-volume, automated processing of UTI screening—eliminating manual strip handling and subjective visual reading while enabling continuous, walk-away operation. For the patient presenting with dysuria, frequency, or suprapubic pain, high-throughput UTI screening enables rapid antibiotic therapy decisions, reducing symptom duration and preventing progression to pyelonephritis, urosepsis, or pregnancy complications.
2. Large-Scale Diabetes and Metabolic Disorder Screening
  • Primary Use: Measures urine glucose and ketones for population-based diabetes screening, diabetic ketoacidosis (DKA) detection, and metabolic disorder surveillance in high-volume public health programs .
  • How it helps: For the endocrinologist and public health physician, the CL-500 Plus’s 550-test-per-hour throughput and automatic strip feeding support mass screening campaigns in community health initiatives, mobile health programs, and public health outreach. For the patient, high-volume screening enables early detection of undiagnosed diabetes, prevention of DKA complications, and identification of individuals needing confirmatory blood glucose testing and diabetes management, particularly in underserved populations with limited routine healthcare access.
3. Preeclampsia and Pregnancy Complication Surveillance
  • Primary Use: Detects proteinuria and microalbuminuria, critical markers for preeclampsia and gestational diabetes screening in large obstetrics practices and antenatal clinics .
  • How it helps: For the obstetrician and midwife in high-volume maternity services, the CL-500 Plus’s automated strip feeding and continuous operation mode enables efficient proteinuria screening for large numbers of pregnant women during routine antenatal visits, particularly in busy maternity hospitals, prenatal clinics, and mobile maternal health programs. For the pregnant patient, early detection of proteinuria triggers timely referral and management, reducing the risk of eclampsia, preterm delivery, placental abruption, and maternal-fetal mortality, especially in resource-limited settings where advanced obstetric care may be distant.
4. Chronic Kidney Disease (CKD) Surveillance and Program Monitoring
  • Primary Use: Measures microalbumin, creatinine, microalbumin-to-creatinine ratio (ACR), and protein for chronic kidney disease surveillance, diabetic nephropathy monitoring, and hypertension-related renal damage assessment in high-volume testing environments .
  • How it helps: For the nephrologist and public health program manager, the CL-500 Plus’s bidirectional LIS connectivity and 5,000-result memory enable efficient integration with electronic medical records for CKD surveillance programs, longitudinal patient monitoring, and public health reporting. For the patient with hypertension, diabetes, or established CKD, regular microalbumin and protein monitoring via high-throughput urinalysis enables early detection of nephropathy progression, timely adjustment of renoprotective therapy (ACE inhibitors, ARBs), and referral to nephrology services—critical for slowing disease progression and preserving residual renal function.

SECONDARY & SUPPORTIVE USES

1. Population Health Screening and Public Health Campaigns: Supports mass screening for diabetes, kidney disease, and UTIs in community health initiatives, workplace wellness programs, and public health outreach across entire districts .
2. Large Clinic and Maternity Hospital Services: Enables efficient urinalysis for busy antenatal clinics, outpatient departments, family medicine centers, and urgent care facilities with high patient volumes.
3. Hospital Central Laboratory Backup: Serves as high-capacity backup urinalysis system for emergency departments, inpatient wards, and outpatient clinics when primary analyzers are unavailable .
4. Centralized Screening for Ministry of Health Programs: Supports government health initiatives for non-communicable disease screening, maternal-child health, and early disease detection at district and regional levels.
5. Diabetes and Prediabetes Community Screening: Supports large-scale community screening for diabetes risk among adults, school-age children, and high-risk populations .
6.  Antenatal Clinic High-Volume Testing: Enables efficient proteinuria and glucose screening in large obstetrics practices, midwife-led units, and maternity hospitals.
7. Hypertension and Cardiovascular Risk Programs: Supports renal function screening in hypertensive patients for early detection of hypertensive nephropathy.
8. NGO and International Health Organization Outreach: Deployable for high-volume screening campaigns in low-resource settings, refugee health programs, and disaster response .
9. Research and Clinical Trials: Supports urinalysis for large clinical trials requiring standardized, high-throughput testing protocols.
10. Occupational Health and Pre-Employment Screening: Enables efficient urinalysis for pre-employment health assessments, occupational health surveillance, and workplace wellness programs.
11. Veterinary Reference Laboratory Testing: Supports high-volume urinalysis in veterinary reference laboratories serving large animal hospitals and clinics.
12. Pharmaceutical and Nutraceutical Clinical Research: Provides standardized urinalysis for clinical trials of diabetes medications, nephroprotective agents, and urinary tract therapeutics.
13. Long-Term Care and Elderly Health Monitoring: Supports routine urinalysis screening for UTIs, dehydration, and kidney function in skilled nursing facilities and assisted living communities.
14. School and University Health Services: Enables efficient urinalysis for student health programs, sports physicals, and disease surveillance in educational institutions.
15. Remote Laboratory Outreach Programs: Deployable for high-volume testing in rural health posts, mobile laboratory services, and community diagnostic camps .
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A high-throughput semi-automated urine test strip analyzer with automatic strip feeding, using reflectance photometry for quantitative measurement of up to 14 urinary parameters .
  • Designation: CL-500 Plus Semi-Automated Urine Analyzer, HTI CL-500 Plus, High-Throughput Urine Analyzer, Automated Urine Test Strip Analyzer .
  • Key Components:
o Optical System: LED reflectance photometry with wavelengths at 550nm, 620nm, and 720nm for optimized parameter detection .
o Strip Feeder: Automatic strip feeding mechanism enabling continuous loading without operator intervention .
o Test Strip Compatibility: Open system design accepting standard urine test strips (multi-parameter strips) .
o Waste Container: Built-in onboard waste collection for used test strips .
o Display: Microprocessor-based control system with real-time alerts and operational messages .
o Printer: Built-in thermal printer (external printer optional) for immediate result documentation .
o Memory: Internal storage for 5,000 test results with full data retention .
o Connectivity: Bidirectional LIS interface, RS-232, PS/2 input, parallel input, WiFi, USB .
o Barcode Scanner: Optional external barcode reader for patient identification .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Methodology: Reflectance photometry (reflectance spectrophotometry) with cold light LED source (long life, high stability) .
  • Measurement Wavelengths: 550nm, 620nm, 720nm .
  • Throughput: Up to 550 strips per hour (continuous operation with automatic feeding) .
  • Maximum Parameters: Up to 14 tests simultaneously per strip .
  • Test Time: 65 seconds .
  • Operating Modes: Continuous operation with automatic strip feeding .
  • Strip Detection: Automatic .
  • Measurement Parameters (14 parameters): Leukocytes, ketone, nitrite, protein, glucose, blood, calcium, ascorbic acid, urobilinogen, bilirubin, specific gravity, microalbumin, pH, creatinine .
  • Memory Capacity: 5,000 test results .
  • Languages: English, Russian, Spanish, Ukrainian .
  • Calibration: Automatic self-checking; internal calibration for strip sensitivity .
  • Quality Control: Automatic self-check with real-time alerts and operational messages .
  • Patient Input: Barcode scanner (optional), numerical sample identification .
  • Operating System: Microprocessor-based .
  • Alerts: Real-time messages, operational alerts for instrument status .
  • Connectivity: Bidirectional LIS, RS-232, PS/2 input, parallel input, WiFi, USB .
  • Power Requirements: 110-240V, 50/60Hz, 30VA .
  • Operating Temperature: 15°C to 30°C .
  • Operating Humidity: 10% to 90% (non-condensing) .
  • Dimensions (W x H x D): 31 cm x 29.5 cm x 33 cm .
  • Weight: 6.5 kg .
  • Manufacturer: High Technology Inc. (HTI), USA .
  • Warranty: Standard manufacturer warranty per HTI policy.

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Benchtop design with durable housing; compact footprint for high-throughput laboratory placement .
  • Portability: Semi-portable at 6.5 kg; designed for fixed laboratory installation rather than field transport.
  • User Interface: Microprocessor-based control system with intuitive menu interface; real-time operational alerts .
  • Operation: Semi-automated high-throughput; operator loads strips into automatic feeder; instrument processes continuously; results automatically printed and stored .
  • Strip Feeding: Continuous automatic strip loading without operator intervention; improves workflow efficiency for high-volume laboratories .
  • Waste Management: Built-in onboard waste collection container; reduces operator contact with used test strips .
  • Timers: Integrated test timing; automatic result generation at 65 seconds .
  • Calibration: Automatic self-checking on startup; internal calibration for strip sensitivity .
  • Quality Control: External QC materials compatible; automatic self-check verification.
  • Data Management: 5,000 result memory; results can be printed, stored, or exported via multiple connectivity options (RS-232, USB, WiFi) .
  • Alerts: Real-time operational alerts for instrument status, strip errors, and maintenance needs .
  • Connectivity: Comprehensive connectivity suite with bidirectional LIS interface for full laboratory information system integration; supports RS-232, USB, WiFi, PS/2, and parallel ports .
  • Patient ID: Optional barcode scanner for efficient patient identification and sample tracking.
  • Maintenance: Minimal daily maintenance; user-replaceable thermal paper; automated internal cleaning protocols.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: In Vitro Diagnostic (IVD) medical device; requires country-specific registration per local regulations. Manufactured by High Technology Inc. (HTI), USA .
  • Safety Certifications: CE marked; compliant with applicable international safety standards.
  • Infection Control: Automatic strip feeding minimizes operator contact with test strips; built-in waste container for safe disposal; standard precautions recommended .
  • Electrical Safety: Wide voltage compatibility (110-240V, 50/60Hz) for international use; low power consumption (30VA) for energy efficiency; ground protection .
  • Operating Environment: Designed for indoor laboratory or clinical point-of-care use at 15-30°C; maximum humidity 90% .
  • Quality Assurance: Automatic self-checking and internal calibration; external QC materials available.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in clean, dry environment at 15-30°C; protect from dust, vibration, and direct sunlight .
  • Cleaning: Wipe exterior with soft, damp cloth using mild detergent; follow standard disinfection protocols for clinical surfaces.
  • Test Strip Storage: Store test strips per manufacturer instructions; protect from humidity; check expiration dates.
  • Waste Disposal: Empty built-in waste container regularly per facility biohazard protocols; dispose of used test strips as biohazard waste.
  • Maintenance: Annual calibration verification recommended; 12-month manufacturer warranty typical.
  • Installation: Benchtop installation requires 31 x 33 cm footprint with access to electrical outlet; connectivity to LIS via RS-232, USB, or WiFi recommended for data management.
  • Connectivity Setup: LIS integration requires IT support for bidirectional interface configuration.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: High-throughput semi-automated urinalysis for UTI diagnosis, diabetes screening, preeclampsia detection, chronic kidney disease monitoring, and liver disease screening in large clinical laboratories, hospital settings, public health programs, and high-volume point-of-care facilities .
  • Clinical Role: Essential high-volume diagnostic instrumentation for public health screening programs, large hospital laboratories, regional referral laboratories, Ministry of Health surveillance programs, NGO health campaigns, antenatal clinics, maternity hospitals, and community health initiatives requiring efficient, high-throughput urinalysis .
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Biohazard Exposure: Treat all samples as potentially infectious; use standard precautions (gloves, lab coat) when handling urine specimens; dispose of used test strips in built-in waste container per facility biohazard protocol .
  • Electrical Safety: Use properly grounded outlet; wide voltage tolerance (110-240V, 50/60Hz) ensures safe international use; 30VA low power consumption .
  • Test Strip Handling: Use only manufacturer-recommended standard urine test strips (open system); do not use expired or improperly stored strips; handle strips by end only to avoid contamination .
  • Quality Control: Run external QC materials per laboratory schedule; verify calibration using automatic self-check before patient testing .
  • Environmental Conditions: Operate within specified temperature (15-30°C) and humidity (10-90%) ranges for accurate results .
  • Waste Management: Empty built-in waste container regularly; do not allow container to overfill; dispose as biohazard waste .
  • Mechanical Safety: Keep automatic strip feeder clear of obstructions; do not insert objects into strip feed mechanism.
  • Cleaning: Clean spills immediately; follow facility disinfection protocols; do not immerse unit in liquid.
  • Training: Only trained laboratory personnel should operate the CL-500 Plus for clinical diagnostic applications.

2. FIRST AID MEASURES

  • Sample Exposure: Wash exposed skin immediately with soap and water; flush eyes with water for 15 minutes; follow institutional exposure management protocol.
  • Electrical Malfunction: Disconnect power immediately; do not attempt repair; contact service provider.
  • Thermal Printer: Printer may become warm during operation; allow to cool before servicing.
  • Mechanical Jam: If strip feeder jams, power off, remove jammed strip carefully using forceps, and restart.

3. FIRE FIGHTING MEASURES

  • Flammability: Electrical hazard; test strips may be combustible.
  • Extinguishing Media: Use CO₂ or dry chemical extinguisher for electrical fires.
  • Fire Response: Disconnect power; use appropriate extinguisher; do not use water on electrical fire.