KRISTELLER Specula deep 110x30mm Fig.2

KRISTELLER SPECULUM • DEEP-CONCAVE 110x30mm • FIG.2 • CE-CLASS I • ISO 13485:2016

Maxi Deep-Concave Speculum for Operative Gynecological Procedures

The KRISTELLER Deep-Concave Speculum Fig.2 (110x30mm) is a medical device of CE class I according to ISO 13485:2016. This maxi speculum with deep-concave construction was specifically developed for operative gynecological procedures requiring maximum visibility with optimal tissue preservation.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Maxi deep-concave design 110x30mm – for surgical procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Deep-concave maxi blade construction – optimal tissue preservation with surgical visibility
✔ Reinforced construction – for stable surgical instrumentation
✔ Atraumatic blade edges – patient comfort during major procedures
✔ Industrial locking mechanism – maximum locking stability
✔ Ergonomic oversize handles – for optimal control during surgeries
✔ 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.2 110x30mm:

• Deep-concave maxi construction for surgical procedures
• Maximum visibility with optimal tissue preservation
• Extremely stable for demanding surgical techniques
• Ideal for vaginal surgical procedures
• Perfectly coordinated for teaching and surgical training

Fields of Application:

• Vaginal hysterectomies
• Operative vaginal plasties
• Urogynecological reconstruction procedures
• Extended conizations and trachelectomies
• Removal of larger pathologies
• Complex fistula surgical procedures
• Reconstructive vaginal surgical techniques

Technical Specifications:

• Model: KRISTELLER Speculum deep-concave Fig.2
• Dimensions: 110mm length, 30mm width (closed)
• Maximum opening width: 45mm
• Special feature: Deep-concave maxi blade construction
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Industrial locking mechanism
• Blade shape: Maxi-wide, deep-concave, reinforced
• Surface: High-gloss polished, satin finish
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C
• Weight: 380g

Important Safety Information:
• For professionals experienced in operative gynecology only
• Special care required during positioning of maxi component
• Check stable fit and correct alignment
• Specifically for surgical procedures with appropriate indication
• Regular inspection of stability and functionality recommended