KRISTELLER Specula 90x36mm and Retractor 100x32mm Fig.3

KRISTELLER SPECULUM • 90x36mm AND HOLDER • 100x32mm FIG.3 SET • CE-CLASS I • ISO 13485:2016

Ultra-Maxi Complete Set for Complex Vaginal Surgical Procedures

The KRISTELLER Speculum Set (90x36mm speculum with 100x32mm holder Fig.3) is a medical device of CE class I according to ISO 13485:2016. The ultra-maxi set was specifically developed for highly complex vaginal surgical procedures requiring maximum exposure and most stable guidance of specialized instruments.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Ultra-maxi complete set 90x36mm speculum + 100x32mm holder Fig.3
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Ultra-maxi precision speculum – for maximum surgical visibility
✔ Heavy-duty holder Fig.3 – for secure guidance of specialized surgical instruments
✔ Perfectly matched ultra components – specifically for most complex procedures
✔ Reinforced atraumatic edges – maximum patient comfort during major procedures
✔ Industrial oversize handles – for optimal control during lengthy 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 90x36mm with Holder 100x32mm Fig.3:

• Ultra-maxi dimensions for most complex surgical procedures
• Maximum exposure for major vaginal surgeries
• Extremely stable for heaviest surgical instrumentation
• Ideal for reconstructive and oncological vaginal surgery
• Perfectly coordinated for specialized surgical centers

Fields of Application:

• Complex vaginal oncology procedures
• Urogynecological maximum reconstructions
• Reconstruction for high-grade prolapse
• Complex fistula surgical reconstructions
• Vaginal hysterectomies for uterine fibroids
• Extended vaginal plasties with mesh implants
• Special teaching procedures in reference centers

Technical Specifications Speculum:
• Model: KRISTELLER Speculum Ultra-Maxi
• Dimensions: 90mm length, 36mm width (closed)
• Maximum opening width: 55mm
• Material: Surgical Steel 1.4021

Technical Specifications Holder:
• Model: KRISTELLER Holder Fig.3
• Dimensions: 100mm length, 32mm width
• Material: Surgical Steel 1.4021
• Compatibility: Specifically matched to speculum 90x36mm

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. 850g

Important Safety Information:
• Exclusively for highly specialized vaginal surgical professionals
• Special expertise in positioning ultra-maxi instruments required
• Check absolutely stable fit and correct alignment
• Specifically for most complex surgical procedures in specialized centers
• Intensive post-operative monitoring required