KRISTELLER Specula flat hollow 105x33mm Fig.3

KRISTELLER SPECULUM • FLAT 105x33mm • FIG.3 • CE-CLASS I • ISO 13485:2016

Maxi Flat Precision Speculum for Operative Gynecological Procedures

The KRISTELLER Flat Speculum Fig.3 (105x33mm) is a medical device of CE class I according to ISO 13485:2016. The maxi flat design was specifically developed for operative gynecological procedures requiring maximum visibility with minimal tissue pressure.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Maxi flat design 105x33mm – for surgical procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Ultra-flat blade construction – minimal tissue pressure with maximum visibility
✔ Maxi-wide but flat construction – optimal balance for surgeries
✔ Reinforced atraumatic blade edges – patient comfort during major procedures
✔ Industrial locking mechanism – maximum locking stability
✔ Robust 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 Flat Speculum Fig.3 105x33mm:

• Maxi-flat construction for surgical procedures
• Maximum visibility with minimal tissue pressure
• Extremely stable for demanding surgical instrumentation
• Ideal for vaginal surgical procedures with flat profile
• 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 flat Fig.3
• Dimensions: 105mm length, 33mm width (closed)
• Maximum opening width: 50mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Industrial locking mechanism
• Blade shape: Ultra-flat, maxi-wide, reinforced
• Surface: High-gloss polished, satin finish
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C
• Weight: 420g

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