KRISTELLER Specula 70x27mm Fig.1

KRISTELLER SPECULUM • 70x27mm • FIG.1 • CE-CLASS I • ISO 13485:2016

Extended Precision Speculum for Therapeutic Gynecological Procedures

The KRISTELLER Speculum Fig.1 (70x27mm) is a medical device of CE class I according to ISO 13485:2016. The extended precision speculum was specifically developed for therapeutic procedures and demanding diagnostic techniques requiring enhanced visibility and more stable instrumentation.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Extended precision design 70x27mm – for therapeutic procedures
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Extended blade width – for optimal procedure visibility
✔ Reinforced locking mechanism – stable locking
✔ Atraumatic rounded edges – maximum patient comfort
✔ Ergonomic handles – for optimal control during procedures
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Speculum Fig.1 70x27mm:

• Extended construction for therapeutic procedures
• Optimal visibility during extended diagnostic procedures
• More stable construction for therapeutic instrumentation
• Ideal for procedures with extended instrumentation
• Perfectly coordinated for demanding 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:

• Model: KRISTELLER Speculum Fig.1
• Dimensions: 70mm length, 27mm width (closed)
• Maximum opening width: 38mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Reinforced locking mechanism
• Blade shape: Extended, stable, atraumatic
• 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 speculum
• Check proper fit and stability
• Only for procedures with appropriate indication
• Regular inspection of functionality recommended