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Packaging Specifications

Description

8‑inch Color LCD Screen 6‑Parameters Patient Monitor

Professional Medical Device Product Description

The 8‑inch color LCD screen 6‑parameters patient monitor is a professional‑grade patient monitoring system designed for healthcare applications. This device integrates advanced biomedical engineering with clinical expertise, and is manufactured to comply with international medical device standards and regulatory requirements.

Engineered for demanding clinical environments, this monitor delivers stable and reliable performance. Adopting state‑of‑the‑art technology and human‑oriented design, it enables efficient operation by trained medical professionals. It is globally applicable to hospitals, clinics, diagnostic centers, imaging facilities and medical research institutions.

Extensive R&D and clinical testing have been carried out for this product to guarantee patient safety, treatment efficacy and equipment operational reliability. Each unit is subject to strict quality‑control testing, meeting or exceeding international regulatory requirements and quality standards.

Key Product Features

‑ Multi‑parameter patient monitoring capability
‑ Real‑time vital signs display and recording
‑ Advanced alarm and alert systems
‑ Data storage and retrieval capability
‑ Network connectivity for remote monitoring
‑ User‑friendly display interface

Detailed Technical Specifications

表格

ParameterSpecification
Product Name8‑inch Color LCD Screen 6‑Parameters Patient Monitor
Product TypePatient Monitoring System
Quality StandardInternational Medical Device Standards (ISO 13485, ISO 10993)
Regulatory CertificationsFDA Approved, CE Marked, ISO 13485 Certified
Sterilization MethodEthylene Oxide (EO) Sterilization or equivalent
Sterility Assurance Level10⁻⁶ (meets ISO 11135 standards)
Shelf Life5 years from sterilization date under proper storage
Storage Conditions15‑25 ℃, dry environment, away from direct sunlight

Clinical Applications & Indications

Intended Use: The 8‑inch color LCD screen 6‑parameters patient monitor shall be used only by trained and qualified medical personnel within professional medical environments. It is applied for diagnosis‑ and therapy‑related monitoring in compliance with applicable medical device regulations and clinical practice guidelines.

‑ ICU monitoring: Critical patient care
‑ Operating room monitoring: Intraoperative patient assessment
‑ Emergency department: Acute patient monitoring
‑ Ward monitoring: General patient care
‑ Ambulatory monitoring: Portable patient assessment

Product Advantages & Competitive Benefits

‑ High‑quality imaging and diagnostic capability
‑ Reliable and consistent performance
‑ Intuitive interface for easy operation
‑ Full safety compliance with complete regulatory certifications
‑ Professional technical support and services
‑ Durable construction for long‑term service life
‑ Conforms to international medical device standards

Regulatory Compliance & International Certifications

FDA Approval: Authorized by the U.S. Food and Drug Administration for commercial distribution and clinical use in the United States.
CE Marking: Compliant with EU Medical Devices Regulation (MDR), available for distribution and application across the European Union.
ISO 13485: Produced under ISO 13485‑certified quality management system to guarantee stable product quality.
ISO 10993: Meets ISO 10993 biocompatibility standards for medical devices.
ISO 11135: EO sterilization process complies with ISO 11135 requirements.
International Standards: Satisfies all applicable international medical device standards and regulations.

Usage Guidelines & Best Practices

Operator Training: Operation must be performed by trained and qualified medical personnel following regulatory requirements and manufacturer’s guidelines.
Safety Protocols: Strictly observe all safety protocols and operating instructions specified in product manuals and training materials.
Maintenance & Calibration: Conduct regular maintenance and calibration to secure device performance, measurement accuracy and service life.
Quality Assurance: Operate the device in accordance with medical device regulations, quality standards and institutional protocols.
Professional Support: Dedicated technical team provides assistance, troubleshooting and training services.
Documentation: Keep complete records of equipment usage, maintenance and service for regulatory compliance and quality‑control purposes.

Quality Assurance & Performance Standards

Every unit undergoes rigorous quality‑control testing and validation:
‑ Functional performance and measurement accuracy under clinical conditions
‑ Safety compliance and effectiveness of protective features
‑ Durability and long‑term reliability in clinical‑use scenarios
‑ Verification of regulatory compliance and certifications
‑ User‑interface functionality and operability assessment
‑ Display image quality and diagnostic accuracy verification

Professional Support & Services

Technical Support: 24/7 technical support and troubleshooting assistance
Training Programs: Complete training courses for operators and clinical staff
Maintenance Services: Preventive maintenance and customized service plans
Replacement Parts: Genuine replacement parts and accessories for all components
Regulatory Assistance: Compliance consulting and document‑related support
Clinical Consultation: Expert clinical consultation for optimized device utilization


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