TS-Auto Automated Coagulation Analyzer

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The TS-Auto Automated Coagulation Analyzer is a fully automated, multi-channel benchtop coagulation analyzer using dual magnetic bead electromechanical clot detection technology to measure PT (prothrombin time), APTT (activated partial thromboplastin time), TT (thrombin time), and FIB (fibrinogen) in citrated plasma and serum samples . With a test range of 3-999 seconds, repeatability of <3% CV, and multiple independent channels for simultaneous testing, the analyzer delivers rapid, reliable coagulation profiles for preoperative risk assessment, anticoagulant therapy monitoring, and bleeding disorder diagnosis .
The TS-Auto features a large LCD display, built-in thermal printer, reagent and sample pre-warming positions maintained at 37°C ±1°C, open reagent system compatible with any manufacturer’s reagents, and electronic linked pipette with auto-start trigger for hands-free operation . Calibration curve storage for multiple parameters, 12-month QC data storage for PT, APTT, TT, FIB with dot chart display, RS-232 connectivity for LIS integration, and multi-unit result reporting (sec, %, g/L, mg/dL, IU/mL, %-INR, Ratio, Ratio-INR) ensure laboratory standards compliance .
For the anesthesiologist and hematologist, the TS-Auto delivers preoperative coagulation screening to identify high-risk surgical bleeding, INR monitoring for warfarin dose titration in atrial fibrillation and mechanical heart valve patients, APTT monitoring for heparin therapy, fibrinogen quantification for DIC diagnosis, and factor assays for inherited bleeding disorders (hemophilia A/B, factor deficiencies) . For the patient, accurate coagulation testing enables early detection of bleeding disorders before surgery, safe anticoagulation to prevent stroke and hemorrhage, diagnosis of DIC in critical illness, and appropriate factor replacement for hemophilia—preventing catastrophic bleeding, thrombotic complications, and improving survival across surgical, cardiac, and emergency care settings .
Description

TS-Auto Automated Coagulation Analyzer

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Preoperative Coagulation Screening for Surgical Risk Assessment
  • Primary Use: Provides a fully automated, multi-channel coagulation analyzer using dual magnetic bead electromechanical detection technology to perform coagulation screening tests including PT (prothrombin time), APTT (activated partial thromboplastin time), TT (thrombin time), and FIB (fibrinogen), enabling comprehensive assessment of patients prior to elective surgery .
  • How it helps: For the anesthesiologist and surgeon, the TS-Auto delivers critical coagulation parameters that identify patients at risk for perioperative bleeding—enabling informed decisions about surgical delay, transfusion planning, or preoperative correction of coagulation defects. For the patient undergoing elective surgery, preoperative coagulation screening detects unsuspected bleeding disorders, vitamin K deficiency, or liver disease, preventing catastrophic intraoperative hemorrhage and reducing postoperative complication rates.
2. Anticoagulant Therapy Monitoring for Warfarin and DOAC Management
  • Primary Use: Monitors PT, INR (International Normalized Ratio), and APTT in patients receiving oral anticoagulants including warfarin (Coumadin), direct oral anticoagulants (DOACs), and heparin-based therapies, with built-in INR calculation and reporting .
  • How it helps: For the cardiologist and primary care physician, the TS-Auto’s INR measurement capability enables precise warfarin dose titration—maintaining therapeutic INR within the narrow target range (2.0-3.0 for atrial fibrillation, 2.5-3.5 for mechanical heart valves). For the patient with atrial fibrillation, mechanical heart valve, or venous thromboembolism, regular INR monitoring prevents both ischemic stroke (from subtherapeutic anticoagulation) and catastrophic hemorrhage (from supratherapeutic anticoagulation), enabling safe long-term warfarin therapy.
3. Unfractionated Heparin (UFH) and Low Molecular Weight Heparin (LMWH) Monitoring
  • Primary Use: APTT monitoring for unfractionated heparin therapy assesses anticoagulation adequacy during acute management of venous thromboembolism, myocardial infarction, and cardiac surgery requiring cardiopulmonary bypass .
  • How it helps: For the intensivist and cardiac surgeon, the TS-Auto provides rapid APTT results to titrate intravenous heparin infusions—maintaining therapeutic anticoagulation while preventing bleeding complications. For the patient with acute pulmonary embolism, massive deep vein thrombosis, or during cardiac surgery requiring cardiopulmonary bypass, accurate heparin monitoring prevents life-threatening thrombus extension or devastating intraoperative bleeding.
4. Disseminated Intravascular Coagulation (DIC) Diagnosis and Management
  • Primary Use: Performs comprehensive coagulation panel including PT, APTT, TT, and FIB for diagnosis and monitoring of disseminated intravascular coagulation—a life-threatening condition characterized by simultaneous bleeding and thrombosis .
  • How it helps: For the intensivist and hematologist, the TS-Auto’s multi-channel simultaneous testing capability enables rapid DIC panel completion, identifying the characteristic coagulation abnormalities (prolonged PT/APTT, low fibrinogen, elevated FDPs) that distinguish DIC from other coagulopathies. For the patient with sepsis, trauma, obstetric complications, or malignancy, early DIC diagnosis enables timely intervention with clotting factor replacement, anticoagulation, and treatment of the underlying cause—reducing mortality from this critical complication.

SECONDARY & SUPPORTIVE USES

1. Liver Disease and Coagulopathy Assessment: Evaluates synthetic liver function via PT and INR prolongation in patients with cirrhosis, hepatitis, acute liver failure, and alcoholic liver disease—where the liver’s inability to produce clotting factors increases bleeding risk .
2. Vitamin K Deficiency Detection: Identifies patients with fat malabsorption syndromes (celiac disease, cystic fibrosis, biliary obstruction), prolonged antibiotic use, or malnutrition who develop vitamin K-dependent factor deficiency (factors II, VII, IX, X) with elevated PT.
3. Factor Deficiency Evaluation: Performs mixing studies and factor assays for coagulation factors II, V, VII, VIII, IX, X, XI, XII to diagnose inherited bleeding disorders including hemophilia A (factor VIII deficiency), hemophilia B (factor IX deficiency), and von Willebrand disease .
4. Protein C and Protein S Deficiency Screening: Detects inherited thrombophilias (hypercoagulable states) including protein C and protein S deficiencies—conditions predisposing patients to recurrent deep vein thrombosis, pulmonary embolism, and pregnancy loss .
5. Lupus Anticoagulant (Antiphospholipid Syndrome) Testing: Performs dilute Russell viper venom time (dRVVT) and mixing studies to detect lupus anticoagulant—an autoantibody causing arterial and venous thrombosis, recurrent pregnancy loss, and thrombocytopenia requiring lifelong anticoagulation .
6. Fibrinogen (Factor I) Deficiency and Dysfibrinogenemia Assessment: Quantifies fibrinogen levels via Clauss method for diagnosis of inherited (afibrinogenemia, hypofibrinogenemia) and acquired (DIC, liver disease) fibrinogen disorders affecting bleeding risk.
7. Heparin Contamination Detection (Surgical Specimen Monitoring): Monitors heparin levels during cardiopulmonary bypass, ECMO, and cardiac catheterization procedures requiring precise anticoagulation control while preventing heparin-induced bleeding.
8. Emergency Department (ED) Rapid Coagulation Panel: Supports rapid turnaround (3-999s test time) for emergency department patients presenting with bleeding, bruising, or thromboembolic symptoms, enabling immediate anticoagulation decisions .
9. Obstetric and Pregnancy Complication Monitoring: Assesses coagulation status in pregnant women with preeclampsia, HELLP syndrome, placental abruption, and antiphospholipid syndrome—conditions associated with DIC and thrombotic risk.
10. Neonatal and Pediatric Coagulation Testing: Provides coagulation testing for neonates and children with suspected hemophilia, vitamin K deficiency bleeding (VKDB), and liver disease using small sample volumes.
11. Post-Thrombosis Anticoagulation Monitoring: Monitors warfarin or DOAC therapy following treatment for DVT, PE, or cerebral venous sinus thrombosis, ensuring adequate secondary prevention while minimizing bleeding risk.
12. Outpatient Anticoagulation Clinic Management: Supports PT/INR monitoring in dedicated anticoagulation clinics for patients on long-term warfarin, with electronic data storage and LIS connectivity for result tracking.
13. Clinical Research and Drug Trials: Provides coagulation endpoint measurement for clinical trials of anticoagulant medications, antiplatelet agents, and hemostatic therapies with QC data storage and Levey-Jennings charting.
14. Quality Control and Laboratory Accreditation: Built-in QC data storage for PT, APTT, TT, FIB with dot chart display supports laboratory quality assurance programs, Westgard rule application, and ISO accreditation .
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A fully automated, multi-channel coagulation analyzer (automatic blood coagulation analyzer) using dual magnetic bead electromechanical detection technology for hemostasis testing .
  • Designation: TS-Auto Automated Coagulation Analyzer, Automatic Coagulation Analyzer, Multi-Channel Coagulation Analyzer .
  • Key Components:
  • Detection Channels: 4 or more independent channels for simultaneous PT, APTT, TT, and FIB testing 
  • Pre-incubation Positions: Reagent and sample pre-warming positions maintained at 37°C ±1°C 
  • Display: Large LCD screen with graphics display and functional keyboard 
  • Printer: Built-in high-speed thermal printer; external printer support 
  • Sample Handling: Electronic dispensing pipette with linkage start function - auto start trigger for hands-free operation 
  • Data Storage: 12-month QC storage for PT, APTT, TT, FIB with dot chart display 
  • Connectivity: Standard RS-232 interface; external printer port 

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Detection Principle: Dual magnetic stirrer electromagnetic detection (dual magnetic bead) with photoelectric monitoring; electromechanical clot detection system that eliminates interference from hemolysis, icterus, lipemia, and turbid samples 
  • Channels: 4 or more independent testing channels 
  • Test Range: 3-999 seconds 
  • Temperature Control: 37°C ±1.0°C stability with accurate temperature monitoring 
  • Repeatability (CV%): <3% (standard QC material) 
  • Inter-channel Deviation: ≤3% 
  • Accuracy (FIB): Relative deviation ≤±10% 
  • FIB Measuring Range: 1-12 g/L at 1:20 dilution 
  • Timer Accuracy: ≤0.1% internal clock error 
  • Sample Types: Citrated plasma, serum 
  • Power Requirements: 220V, 50Hz ±1Hz
  • Operating Temperature: 10°C to 30°C 
  • Relative Humidity: ≤70% 
  • Safety Certification: Registered medical device

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Benchtop design with durable housing for stationary laboratory use 
  • User Interface: Large LCD with graphics display; functional membrane keyboard; multi-language support including English and Chinese 
  • Operation: Fully automated or semi-automated workflow; operator pipettes sample using electronic linked pipette; test automatically starts upon pipette trigger; results automatically print 
  • Testing Modes: Manual and auto-manual (linked) sample-adding functions; multiple channels can run same or different tests simultaneously 
  • Calibration: Up to 18 calibration parameter storage; FIB negative correlation curve improves accuracy 
  • Data Management: 12-month PT, APTT, TT, FIB QC data storage with dot chart display; results searchable by date 
  • Connectivity: RS-232 standard interface for LIS/HIS integration; external printer port 
  • Result Units: 8 units available (sec, %, g/L, mg/dL, IU/mL, %-INR, Ratio, Ratio-INR) conforming to international reporting standards 
  • Built-in Features: 4 timers with audible alarm on reaction completion; pre-programmed timing management with alert; one-button fast-test function; emergency call STAT function 
  • Reagent Compatibility: Open system, compatible with any manufacturer's reagents 
  • Random Reporting: Unique random reports and "overall coagulation report sheet" printing capabilities for flexible result documentation 

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: In Vitro Diagnostic (IVD) Medical Device; Class II medical device requiring regulatory registration; Medical Device License No. 津食药监械()20122400039
  • Safety Features: Dual magnetic bead technology eliminates interference from hemolysis, icterus, lipemia, and turbid samples; detection results unaffected by bubbles from pipetting 
  • Detection Reliability: Special photoelectric test procedure ensures accurate clot detection under all sample conditions; test result will not be affected by bubble in the plasma 
  • Electrical Safety: 220V, 50Hz ±1Hz power supply
  • Quality Compliance: Manufacturing under quality management systems; 12-month QC storage ensures compliance with laboratory accreditation standards
  • Sample Integrity: Reagent pre-warming positions maintain 37°C pre-test temperature; timer alerts ensure timing accuracy

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in clean, dry laboratory environment at 10-30°C. Protect from dust, vibration, and direct sunlight
  • Cleaning: Follow decontamination and disinfection protocols per facility guidelines; exterior wipe with soft, damp cloth
  • Maintenance: Annual calibration verification recommended; factory-authorized service available; user-replaceable thermal printer paper
  • Consumables: Requires sample cups and magnetic beads; open reagent system accepts any commercial coagulation reagents 
  • Installation: Benchtop installation requires adequate clearance; stable benchtop placement recommended; electrical outlet required; RS-232 LIS connection optional
  • Calibration: Calibration curves stored; FIB calibration using negative correlation curve; verify calibration per laboratory schedule 

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Automated coagulation testing for preoperative risk assessment, anticoagulant monitoring (PT/INR, APTT), DIC diagnosis, and factor deficiency evaluation in clinical laboratories, hospital settings, and physician offices 
  • Clinical Role: Essential diagnostic instrumentation for anesthesiology, cardiology, hematology, obstetrics, pediatrics, and emergency medicine
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Biohazard Exposure: Treat all patient samples (citrated plasma, serum) as potentially infectious; use standard precautions (gloves, lab coat, eye protection); dispose of waste per facility biohazard protocol
  • Electrical Safety: Use properly grounded outlet; disconnect power before maintenance
  • Reagent Handling: Use reagents as directed; open system compatible with any manufacturer's coagulation reagents ; follow SDS for each reagent; avoid skin and eye contact
  • Sample Integrity: Plasma samples and reagents must be pre-warmed to 37°C prior to testing; pre-warming positions maintain required temperature ; verify pre-warming times before running tests
  • Calibration & QC: Run QC materials per laboratory schedule; verify calibration before patient testing; do not report results if QC fails; use 12-month QC storage for trend analysis 
  • Interference: Hemolysis, icterus, lipemia, and turbidity do not affect results (dual magnetic bead technology); however, inspect samples for clots per standard protocol 
  • Training: Only trained laboratory personnel should operate the TS-Auto 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
  • Reagent Spill: Ventilate area; use absorbent materials; dispose as chemical waste per SDS
  • Electrical Malfunction: Disconnect power immediately; do not attempt repair; contact service provider

3. FIRE FIGHTING MEASURES

  • Flammability: Electrical hazard; reagents 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