Complete Set for Special Gynecological Diagnostics and Procedures
The KRISTELLER Speculum Set (70x15mm speculum with 75x10mm holder Fig.0) is a medical device of CE class I according to ISO 13485:2016. The special set was developed for demanding diagnostic and therapeutic procedures requiring precise guidance and stable positioning.
Product Highlights:
✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Complete set 70x15mm speculum + 75x10mm holder Fig.0
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Precision speculum – for optimal visibility
✔ Special holder Fig.0 – for secure instrument guidance
✔ Perfect coordination – specifically matched components
✔ Atraumatic design – maximum patient comfort
✔ Ergonomic handles – for precise control
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – set complete for immediate use
✔ Multiple use – reusable after sterilization
Advantages of the KRISTELLER Speculum Set 70x15mm with Holder 75x10mm Fig.0:
• Perfectly coordinated set for complex procedures
• Ideal combination of visibility and instrument guidance
• Specifically for demanding diagnostic procedures
• Maximum precision through optimally matched components
• Ideal for teaching and training
Fields of Application:
• Extended colposcopic examinations
• Precise biopsy sampling under visual control
• Therapeutic procedures on the cervix
• Special cervical diagnostics
• Outpatient surgical procedures
• Teaching and diagnostic training
• Complex cytological smear procedures
Technical Specifications Speculum:
• Model: KRISTELLER Speculum
• Dimensions: 70mm length, 15mm width (closed)
• Maximum opening width: 22mm
• Material: Surgical Steel 1.4021
Technical Specifications Holder:
• Model: KRISTELLER Holder Fig.0
• Dimensions: 75mm length, 10mm width
• Material: Surgical Steel 1.4021
• Compatibility: Specifically matched to speculum 70x15mm
Set Details:
• Design: Multiple use
• Surface: High-gloss polished
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C
Important Safety Information:
• For professionals experienced in special gynecological diagnostics only
• Special care required during holder positioning
• Only use as intended with matched set
• Check proper fit of both components before use
• Regular inspection of component compatibility recommended
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