KRISTELLER Specula 80x30mm and Retractor 85x26mm Fig.2

KRISTELLER SPECULUM • 80x30mm AND HOLDER • 85x26mm FIG.2 SET • CE-CLASS I • ISO 13485:2016

Maxi Complete Set for Operative Gynecological Procedures

The KRISTELLER Speculum Set (80x30mm speculum with 85x26mm holder Fig.2) is a medical device of CE class I according to ISO 13485:2016. The maxi set was specifically developed for operative gynecological procedures requiring maximum visibility and most stable instrument guidance.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Maxi complete set 80x30mm speculum + 85x26mm holder Fig.2
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Maxi precision speculum – for optimal surgical visibility
✔ Industrially reinforced holder Fig.2 – for secure guidance of surgical instruments
✔ Perfectly matched maxi components – specifically for operative procedures
✔ Reinforced atraumatic edges – maximum patient comfort during larger procedures
✔ Robust oversize handles – for optimal control during surgeries
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – set complete for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Speculum Set 80x30mm with Holder 85x26mm Fig.2:

• Maxi dimensions for surgical procedures
• Optimal visibility for complex surgical techniques
• Extremely stable for demanding surgical instrumentation
• Ideal for vaginal surgical procedures
• 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 Speculum:
• Model: KRISTELLER Speculum Maxi
• Dimensions: 80mm length, 30mm width (closed)
• Maximum opening width: 45mm
• Material: Surgical Steel 1.4021

Technical Specifications Holder:
• Model: KRISTELLER Holder Fig.2
• Dimensions: 85mm length, 26mm width
• Material: Surgical Steel 1.4021
• Compatibility: Specifically matched to speculum 80x30mm

Set Details:
• Design: Multiple use
• Surface: High-gloss polished, satin finish
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C
• Total weight: Approx. 600g

Important Safety Information:
• For professionals experienced in operative gynecology only
• Special care required during positioning of maxi components
• Check stable fit and correct alignment of both components
• Specifically for surgical procedures with appropriate indication
• Regular inspection of stability and functionality recommended