KRISTELLER Specula deep 110x20mm Fig.0

KRISTELLER SPECULUM • DEEP-CONCAVE 110x20mm • FIG.0 • CE-CLASS I • ISO 13485:2016

Narrow Deep-Concave Speculum for Sensitive Gynecological Diagnostics

The KRISTELLER Deep-Concave Speculum Fig.0 (110x20mm) is a medical device of CE class I according to ISO 13485:2016. This narrow speculum with deep-concave construction was specifically developed for sensitive examinations of virginal patients and adolescents.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Narrow deep-concave design 110x20mm – for sensitive diagnostics
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Deep-concave blade construction – optimal gentleness with good visibility
✔ Narrow configuration – for virginal and adolescent anatomy
✔ Conical blade ends – atraumatic insertion
✔ Precise fine mechanism – sensitive locking
✔ Ergonomic fine grips – for maximum control
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Deep-Concave Speculum Fig.0 110x20mm:

• Deep-concave construction for optimal tissue preservation
• Narrow construction for virginal and adolescent patients
• Good diagnostic possibilities with maximum patient comfort
• Ideal for adolescent gynecology and sensitive initial examinations
• Perfect for transition examinations

Fields of Application:

• Gynecological initial examinations in virginal patients
• Adolescent gynecological diagnostics
• Examinations of sensitive patients
• Sensitive colposcopic procedures
• Diagnostics in narrow anatomy
• Psychosomatic-gynecological examinations
• Transition examinations from adolescence to adulthood

Technical Specifications:

• Model: KRISTELLER Speculum deep-concave Fig.0
• Dimensions: 110mm length, 20mm width (closed)
• Maximum opening width: 28mm
• Special feature: Deep-concave blade construction
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Precise fine mechanism
• Blade shape: Narrow, deep-concave, conical
• 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 gynecology only
• Sensitive and empathetic examination technique required
• Detailed education and patient consent essential
• Discontinue examination immediately if resistance occurs
• Specifically designed for sensitive examination situations