Ultra-Thin Medical Device Heating Solution for Precision Thermal Management
Core Value: Ultra-thin polyimide Kapton heater film engineered for critical medical applications requiring precise, uniform heating in compact spaces. 12V DC operation with 50W output delivers rapid thermal response. Sterilization-compatible (autoclave, EtO, gamma). 0.15mm thickness enables integration in space-constrained devices. BACKED BY 30+ YEARS MANUFACTURING EXPERIENCE and UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS including 100% dielectric testing for zero-defect medical reliability.
- ✓ Medical Grade: Biocompatible
- ✓ Ultra-Thin: 0.15mm profile fits tight spaces
- ✓ Rapid Response: Reaches 100°C in 30 seconds
- ✓ Uniform Heating: ±2°C temperature uniformity
- ✓ Sterilizable: Autoclave, EtO, gamma compatible
- ✓ Low Outgassing: Suitable for cleanroom use
- ✓ High Dielectric Strength: >3000V AC isolation
- ✓ Reliable Quality: 30+ YEARS MANUFACTURING EXPERIENCE
- ✓ Quality Assured: UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS
- ✓ Global Standards: CE, LVD, RoHS, ISO 9001 certified
Technical Specifications & Performance Data
- Custom laser cutting available
| Parameter | Standard Value | Customizable Range | Notes |
|---|---|---|---|
| Voltage Rating | 12V DC (medical safety) | 5V – 48V DC / AC | Low-voltage patient safety |
| Power Rating | 50W (±3% tolerance) | 10W – 200W | Precision wattage control |
| Heater Dimensions | 50×100×0.15mm (L×W×H) | 10mm – 500mm any shape | |
| Active Area | 45×95mm heating zone | Custom element layout | Uniform winding pattern |
| Sterilization Compatibility | Autoclave 135°C, EtO, Gamma | Validation documentation | 5-cycle validation tested |
| Max Temperature | 150°C continuous | 200°C (special design) | 200°C short-term peak |
| Dielectric Strength | >3000V AC (medical grade) | 5000V AC (high reliability) | Patient isolation safety |
| Insulation Resistance | >1000MΩ @ 500V DC | >10,000MΩ available | Moisture-resistant sealing |
| Watt Density | 0.5 W/cm² (uniform) | 0.3 – 1.5 W/cm² | Optimized for response time |
| Lead Wires | 2× PTFE 26AWG 300mm | Custom length/gauge | Biocompatible jacket |
| Warranty | 1 Year Standard | Quality assured | COMPREHENSIVE QUALITY ASSURANCE |
Medical & Life Science Applications
- Patient Warming Systems: Surgical table warming, neonatal care, hypothermia prevention. 12V DC ensures electrical safety. Biocompatible materials direct skin contact. Uniform heating prevents thermal injury.
- Diagnostic Equipment: PCR thermal cycler heating blocks, blood analyzer reagent warming. ±2°C uniformity ensures test accuracy. Rapid response reduces cycle time. Low outgassing prevents contamination.
- Surgical Instrument Warming: Laparoscopic lens defogging, irrigation fluid warming. Sterilization compatibility enables reuse. Compact profile integrates in instrument handles. Precise temperature control prevents protein denaturation.
- Pharmaceutical Processing: API temperature maintenance, lyophilization chamber heating. High Class materials prevent contamination. Cleanroom manufacturing compliant. Material traceability for batch records. Validated thermal performance.
- DNA Sequencing Systems: Flow cell temperature control, reagent reservoir warming. Thermal uniformity critical for read accuracy. Low-vibration design. Chemically resistant to sequencing reagents. Proven in next-gen sequencing platforms.
- Analytical Instruments: Mass spectrometer inlet heating, chromatography column warming. Ultra-thin design minimizes thermal mass. Rapid ramp rates. Stable long-term operation. Reduces analyte carryover.
HT-Heater vs Standard Market Heaters
| Feature | HT-Heater Medical Grade | Standard Market Kapton | Your Advantage |
|---|---|---|---|
| Certification | LVD,ROHS,ISO 9001,CE | No certification | Direct patient contact safe |
| Thickness | 0.15mm ultra-thin | 0.25mm – 0.5mm | Fits space-constrained devices |
| Wattage Tolerance | ±3% precision | ±10% typical | Consistent thermal performance |
| Dielectric Strength | >3000V AC medical grade | 1500V AC standard | Patient isolation protection |
| Sterilization | Validated for 100+ cycles | Not validated | Reusable in sterile applications |
| Outgassing | <0.1% TML (ASTM E595) | >1% TML | Cleanroom/ultra-high vacuum safe |
| Manufacturing Environment | ISO Class 7 cleanroom | Standard factory floor | Particle-free, medical quality |
| Quality Assurance | UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS | Basic continuity test | ZERO DEFECT for critical applications |
| Regulatory Support | FDA 510(k) documentation | No support | Accelerates device approval |
Installation & Integration Guidelines
- Mounting Methods: 3M 467MP medical-grade adhesive backing. Mechanical clamping with silicone pad. Pressure-sensitive adhesive pattern. Avoid air bubbles for optimal thermal contact. Surface roughness <0.8μm recommended.
- Electrical Connection: 12V DC power supply, ripple <5%. Current: 4.2A @ 50W. Use gold-plated crimp terminals. Avoid solder joints near heater (stress point). Strain relief mandatory. Twisted pair wiring reduces EMI.
- Temperature Control: Integrated RTD PT1000 option. External PID controller recommended. PWM frequency 1-10kHz. Current limiting for cold-start surge. Over-temperature fuse 150°C backup. Ground fault interrupt for patient safety.
- Sterilization Protocol: Autoclave: 121-135°C, 15-30 min, validated 100 cycles. EtO: Standard medical cycle, aeration required. Gamma: 25-50kGy validated. Post-sterilization: Test insulation resistance. Replace if <100MΩ.
Customer Success Stories
Case 1: Surgical Device OEM (USA)
Application: Patient warming mattress for cardiac surgery
Challenge: FDA 510(k) required biocompatible heater with ±2°C uniformity and sterilization capability
Solution: Custom 50W Kapton heaters with integrated PT1000, 5000 units
Results: FDA 510(k) CLEARED IN 4 MONTHS. Zero field failures in 3 years. Reduced hypothermia cases by 40%.
Client Quote: “HT-Heater UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS – the documentation package was FDA-ready. Unmatched medical expertise.” – VP Regulatory Affairs
Case 2: PCR Instrument Manufacturer (Germany)
Application: Thermal cycler heating block for COVID-19 testing
Challenge: Ramp rate 10°C/sec, uniformity ±2°C, MTBF >50,000 hours for high-throughput labs
Solution: 12V Kapton heaters with precision element winding, 12,000 units
Results: 15% FASTER TEST CYCLES than competitors. 99.8% reliability in 24/7 operation. Instrument won “Best of 2021” award.
Client Quote: “30+ YEARS MANUFACTURING EXPERIENCE shows in the thermal uniformity. Every heater performs identically – critical for our validation.” – Chief Engineer
Case 3: Neonatal Incubator OEM (Japan)
Application: Micro-preemie incubator mattress heating
Challenge: Direct neonate skin contact, ISO 10993 compliance, temperature accuracy ±1°C
Solution: Medical-grade Kapton heaters with dual PT100 sensors, 2000 units
Results: PASSED ISO 10993 CYTOTOXICITY, SENSITIZATION, IRRITATION. Temperature stability ±0.5°C. JMDN certification obtained.
Client Quote: “The ISO 10993 documentation and ULTRA-THIN 0.15mm design were perfect. HT-Heater’s 30+ YEARS MANUFACTURING EXPERIENCE made regulatory approval smooth.” – Quality Manager
Pricing & Procurement Options
Sample Orders: Prototype quantities available for design validation. Includes biocompatibility certificates. All samples UNDERGO MULTIPLE RIGOROUS QUALITY CHECKS.
Standard Production: MOQ 10 pieces (medical lot size). BACKED BY 30+ YEARS MANUFACTURING EXPERIENCE ensures consistency. Cleanroom production lot records provided.
Custom Configurations: Any shape, size, wattage, voltage. Integrated RTD/thermocouple options. Multi-zone heating patterns. Sterilization validation support. All custom heaters UNDERGO MULTIPLE RIGOROUS QUALITY CHECKS.
Lead Times: Standard: 7-10 days production. Custom: 10-14 days. Samples: 5-7 days. Expedited service available.
Global Logistics: We use UPS, DHL, FedEx, EMS, TNT or the shipping agent as your request. Every delivery backed by 30+ YEARS MANUFACTURING EXPERIENCE.
Global Medical Certifications & Compliance
- CE Marking
Medical Device Directive
Class IIa device component - LVD Compliance
Low Voltage Directive
Patient safety isolation - RoHS Compliant
Restriction of Hazardous Substances
Medical device environmental std - ISO 9001
Medical Device Quality System
cGMP manufacturing compliance
Quality Documentation: Every unit UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS including 100% dielectric and IR testing.
Comprehensive Medical Device Support
Warranty: 1 Year Standard Warranty with extended options. Covers performance drift, delamination, and out-of-spec resistance. COMPREHENSIVE QUALITY ASSURANCE backed by 30+ YEARS MANUFACTURING EXPERIENCE.
Technical Support: Application engineering for medical thermal design. Biocompatibility documentation package. Sterilization validation guidance. Temperature mapping consultation.
Regulatory Support: BACKED BY 30+ YEARS MANUFACTURING EXPERIENCE. UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS ensures regulatory compliance. Change control notification service.
Quality Commitment: 100% dielectric strength testing (3000V AC). Automated resistance measurement (±1% accuracy).
Ready for Medical-Grade Thermal Solutions?
Next Steps:
- 📧 Request Medical Device Quote
- 📦 Order Sterilization Samples – Validate in your protocols
- 📞 Contact Medical Device Specialists – Response within 2 hours
HT-Heater.com – Medical Device Heating Solutions
30+ YEARS MANUFACTURING EXPERIENCE | UNDERGOES MULTIPLE RIGOROUS QUALITY CHECKS
Medical Kapton Heaters | Biocompatible | Sterilizable
