KRISTELLER Specula 70x15mm Fig.0

KRISTELLER SPECULUM • 70x15mm • FIG.0 • CE-CLASS I • ISO 13485:2016

Narrow Precision Speculum for Special Diagnostic Procedures

The KRISTELLER Speculum Fig.0 (70x15mm) is a medical device of CE class I according to ISO 13485:2016. The narrow precision speculum was specifically developed for demanding diagnostic procedures in sensitive patients, requiring maximum gentleness and precise visibility.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Narrow precision design 70x15mm – for sensitive diagnostics
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Extra narrow blades – for maximum patient comfort
✔ Precise locking mechanism – finely dosed locking
✔ Atraumatic tapered blade ends – low-pain insertion
✔ Ergonomic fine grips – for optimal control
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Speculum Fig.0 70x15mm:

• Extra narrow construction for sensitive examination situations
• Ideal for virginal patients and adolescents
• Maximum patient comfort through atraumatic design
• Perfect for precise diagnostic procedures
• Particularly suitable for examination anxiety and vaginismus

Fields of Application:

• Gynecological initial examinations
• Virginal patients and adolescents
• Pain-sensitive patients
• Special colposcopic diagnostics
• Precise cervical biopsies
• Pediatric and adolescent gynecology
• Psychosomatic-gynecological examinations

Technical Specifications:

• Model: KRISTELLER Speculum Fig.0
• Dimensions: 70mm length, 15mm width (closed)
• Maximum opening width: 22mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Precise locking mechanism
• Blade shape: Extra narrow, tapered, atraumatic
• 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 sensitive gynecological diagnostics only
• Special empathetic examination technique required
• Comprehensive patient education and consent essential
• Discontinue examination immediately if resistance occurs
• Specifically for sensitive and anxiety-charged examination situations