KRISTELLER Specula flat 105x26mm and Retractor 115x22mm Fig.1 Set

KRISTELLER SPECULUM • FLAT 105x26mm AND HOLDER • 115x22mm FIG.1 SET • CE-CLASS I • ISO 13485:2016

Flat Complete Set for Extended Gynecological Diagnostics and Therapeutic Procedures

The KRISTELLER Flat Speculum Set (105x26mm speculum with 115x22mm holder Fig.1) is a medical device of CE class I according to ISO 13485:2016. The flat design was specifically developed for extended diagnostic and therapeutic procedures requiring minimal tissue pressure and optimal visibility.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Flat complete design 105x26mm/115x22mm – for extended procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Flat blade construction – minimal tissue pressure
✔ Extended but flat construction – optimal balance
✔ Atraumatic blade edges – maximum patient comfort
✔ Precise locking mechanism – continuous locking
✔ Ergonomic handles – for optimal control
✔ 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 105x26mm/115x22mm:

• Flat construction for minimal tissue pressure
• Extended dimensions with flat profile
• Optimal visibility during therapeutic procedures
• Ideal for patients with sensitive anatomy
• Perfectly coordinated set for demanding diagnostics

Fields of Application:

• Extended colposcopic examinations
• Therapeutic procedures on cervix and portio
• Precise biopsy sampling
• Removal of cervical polyps
• Complex cytological smear procedures
• Outpatient surgical gynecological procedures
• Diagnostics for sensitive patients

Technical Specifications Speculum:
• Model: KRISTELLER Speculum flat
• Dimensions: 105mm length, 26mm width (closed)
• Maximum opening width: 38mm
• Special feature: Flat blade construction
• Material: Surgical Steel 1.4021

Technical Specifications Holder:
• Model: KRISTELLER Holder Fig.1
• Dimensions: 115mm length, 22mm jaw width
• Material: Surgical Steel 1.4021
• Compatibility: Specifically matched to speculum 105x26mm

Set Details:
• Design: Multiple use
• Feature: Flat construction for minimal tissue pressure
• 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 extended gynecological diagnostics only
• Special care required during positioning of flat speculum
• Check proper fit and stability
• Only for procedures with appropriate indication
• Regular inspection of functionality recommended