KRISTELLER Specula deep 110x27mm and Retractor 115x23mm Fig.1 Set

KRISTELLER SPECULUM • DEEP-CONCAVE 110x27mm AND HOLDER • 115x23mm FIG.1 SET • CE-CLASS I • ISO 13485:2016

Extended Deep-Concave Set for Therapeutic Gynecological Procedures

The KRISTELLER Deep-Concave Set (110x27mm speculum with 115x23mm holder Fig.1) is a medical device of CE class I according to ISO 13485:2016. This extended set with deep-concave construction was specifically developed for therapeutic procedures and demanding diagnostic techniques.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Extended deep-concave design 110x27mm/115x23mm – for therapeutic procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Deep-concave blade construction – optimal tissue preservation with extended visibility
✔ Reinforced configuration – for therapeutic instrumentation
✔ Atraumatic blade edges – maximum patient comfort
✔ Robust locking mechanism – stable locking
✔ Reinforced holder – secure instrument guidance
✔ Ergonomic 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 Deep-Concave Set 110x27mm/115x23mm:

• Deep-concave construction for therapeutic procedures
• Extended visibility with optimal tissue preservation
• Stable construction for demanding procedures
• Ideal for extended diagnostic and therapeutic interventions
• Perfectly coordinated for outpatient surgical procedures

Fields of Application:

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

Technical Specifications Speculum:
• Model: KRISTELLER Speculum deep-concave Fig.1
• Dimensions: 110mm length, 27mm width (closed)
• Maximum opening width: 38mm
• Special feature: Deep-concave blade construction
• Material: Surgical Steel 1.4021

Technical Specifications Holder:
• Model: KRISTELLER Holder Fig.1
• Dimensions: 115mm length, 23mm jaw width
• Material: Surgical Steel 1.4021
• Compatibility: Specifically matched to speculum 110x27mm

Set Details:
• Design: Multiple use
• Feature: Deep-concave and reinforced
• 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
• Care required during positioning of extended speculum
• Check stable fit and correct alignment
• Only for procedures with appropriate indication
• Regular inspection of functionality recommended