KRISTELLER Specula flat 105x28mm and Retractor 115x24mm Fig.2 Set

KRISTELLER SPECULUM • FLAT 105x28mm AND HOLDER • 115x24mm FIG.2 SET • CE-CLASS I • ISO 13485:2016

Extended Flat Complete Set for Therapeutic Gynecological Procedures

The KRISTELLER Flat Speculum Set (105x28mm speculum with 115x24mm holder Fig.2) 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/115x24mm – 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 – set complete for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Flat Speculum Set 105x28mm/115x24mm:

• 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
• Perfectly coordinated set for surgical procedures

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 Speculum:
• Model: KRISTELLER Speculum flat extended
• Dimensions: 105mm length, 28mm width (closed)
• Maximum opening width: 42mm
• Special feature: Reinforced flat blade construction
• Material: Surgical Steel 1.4021

Technical Specifications Holder:
• Model: KRISTELLER Holder Fig.2
• Dimensions: 115mm length, 24mm jaw width
• Material: Surgical Steel 1.4021
• Compatibility: Specifically matched to speculum 105x28mm

Set Details:
• Design: Multiple use
• Feature: Reinforced flat construction
• 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