KRISTELLER Specula flat hollow 105x28mm Fig.2

KRISTELLER SPECULUM • FLAT 105x28mm • FIG.2 • CE-CLASS I • ISO 13485:2016

Extended Flat Precision Speculum for Therapeutic Gynecological Procedures

The KRISTELLER Flat Speculum Fig.2 (105x28mm) is a medical device of CE class I according to ISO 13485:2016. The extended flat design was specifically developed for therapeutic procedures and demanding diagnostic techniques requiring minimal tissue pressure with extended visibility.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Extended flat design 105x28mm – for therapeutic procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Reinforced flat blade construction – minimal tissue pressure with stability
✔ Extended flat construction – optimal balance between visibility and gentleness
✔ Reinforced atraumatic blade edges – maximum patient comfort
✔ Robust locking mechanism – stable locking
✔ Ergonomic comfort handles – for optimal control during procedures
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Flat Speculum Fig.2 105x28mm:

• Reinforced flat construction for therapeutic procedures
• Extended dimensions with flat profile for optimal visibility
• Minimal tissue pressure even during extended procedures
• Ideal for demanding therapeutic interventions
• Perfect for surgical procedures with flat design

Fields of Application:

• Therapeutic procedures on cervix and portio
• Operative conizations
• Extended biopsy sampling
• Removal of cervical polyps and condylomas
• Therapeutic curettages
• Complex colposcopic procedures
• Outpatient surgical gynecological procedures

Technical Specifications:

• Model: KRISTELLER Speculum flat Fig.2
• Dimensions: 105mm length, 28mm width (closed)
• Maximum opening width: 42mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Robust locking mechanism
• Blade shape: Reinforced flat, extended, 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 therapeutic gynecology only
• Special care required during positioning of extended flat speculum
• Check stable fit and correct alignment
• Only for therapeutic procedures with appropriate indication
• Regular inspection of stability and functionality recommended