Gaitnovate Series accurately measures plantar pressure distribution during standing and walking. It assists in assessing foot type, balance ability, gait patterns, and identifying ulcer-prone areas in diabetic patients.
Sighture's precise, reliable plantar pressure systems serve diverse settings like hospital clinics and research institutes. They provide efficient tools for medical professionals, enhancing clinical outcomes.
Foot Type Diagnosis: Identifying flat feet, high arches, and deformities.
Balance Assessment: Quantifying stability during standing/walking.
Gait Abnormality Detection: Revealing irregular walking/running patterns.
Diabetic Foot Risk Mapping: Locating high-pressure ulcer-prone zones.
Rigorous Quality Management System
Our plantar pressure mapping systems undergo strict quality control under a certified ISO 13485-compliant management system. We implement:
Regular internal audits and comprehensive documentation (Quality Manual, SOPs)
Complete lifecycle controls from design to post-market surveillance
Specialized procedures covering:
Raw material procurement
Production floor control
Warehouse management
Product inspection protocols
Sales compliance
Non-conforming product management
Validated equipment SOPs for manufacturing and testing
Detailed process records ensuring full traceability
This integrated framework guarantees consistent product excellence and system effectiveness throughout our plantar pressure gait systems' development, production, and service phases.
Plantar Pressure Balance Tester
Operation & Maintenance Guide
I. Operation Procedure
1. Setup
Secure computer to trolley with screws
Connect power adapter to AC 220V outlet
Plug pressure platform USB into computer (Ports: A for static, B for dynamic)
2. Software Operation
Launch software via desktop icon
Login using credentials (Default: admin/admin)
Create patient profile: Enter name, mobile, height (mandatory)
3. Static Measurement
Patient stands naturally on Platform A/C
Click [Start Measurement] → [End Measurement] after test
Export PDF report (Foot arch index, pressure distribution)
4. Dynamic Measurement
Patient walks on Platform B following footprint guides
Click [Start Measurement] during walking cycle
Export PDF report (Gait time, step length, pressure ratios)
II. Maintenance Protocol
1. Daily Cleaning
Wipe surfaces with sterile water cloth (1-3 passes)
Disinfect with 75% alcohol cloth (1-3 passes, 3min contact)
Frequency: 2x/day
2. Annual Maintenance
Manufacturer-performed sensor calibration
Functional/safety inspection by authorized technicians
Required tools: PhlexSensorPro software
3. Troubleshooting
Issue
Device offline
No pressure data
Computer won't power
Solution
Reconnect USB securely
Verify platform-mode match (Static=A/C, Dynamic=B)
Check power connection
4. Repair Rules
Adapter/sensor replacement: Manufacturer only
Warranty void if:
Unauthorized modifications
Physical damage/lack of maintenance
Warranty seal broken
III. Critical Safety Notes
Contraindications: Severe cardiopulmonary disease, unhealed leg fractures
Precautions:
Use disposable foot film for hygiene
No liquids on device surfaces
Avoid RF interference (keep phones >1.2m away)
Always exit software before shutdown
Document Version: 20250505
Manufacturer: Hebei Sighture Medical Equipment Technology Co., Ltd.
We provide a 24-month warranty starting from the device delivery acceptance date.
Step 1: Troubleshoot using the manual.
Step 2: Contact us for remote online diagnostics.
Step 3: Request on-site repair via local distributors or authorized service units.
Spare wear parts are available; no consumables are required for this device.
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