SEMM Specula 100mm/17-20mm

SEMM SPECULUM • 100mm/17-20mm • CE-CLASS I • ISO 13485:2016

Variable Examination Speculum for Extended Gynecological Diagnostics

The SEMM Speculum (100mm/17-20mm) is a medical device of CE class I according to ISO 13485:2016. The extended variable speculum with adjustable width was developed for individual anatomical adaptation during more demanding diagnostic and therapeutic procedures.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Extended variable design 100mm/17-20mm – optimal adaptation
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Extended adjustment range – 17-20mm flexible width adaptation
✔ Elongated blades – for improved depth visibility
✔ Atraumatic blade ends – for tissue-friendly examination
✔ Precise adjustment mechanism – continuous locking
✔ Ergonomic handles – for optimal control
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the SEMM Speculum 100mm/17-20mm:

• Extended variable design for optimal anatomical adaptation
• Flexible width adjustment during diagnostic procedures
• Elongated construction for improved depth visibility
• Ideal for more demanding diagnostic procedures
• Maximum patient comfort through individual adaptation

Fields of Application:

• Extended gynecological examinations
• Colposcopic diagnostics with variable anatomy
• Therapeutic procedures under visual control
• Individually adapted biopsy sampling
• Insertion of intrauterine devices
• Special urogynecological diagnostics
• Outpatient surgical procedures

Technical Specifications:

• Model: SEMM Speculum extended variable model
• Dimensions: 100mm length, 17-20mm variable width
• Maximum opening width: 35mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Precise adjustment mechanism
• Adjustment range: 17-20mm width
• Blade shape: Elongated, variable
• Surface: High-gloss polished
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C

Important Safety Information:
• For experienced gynecological professionals only
• Sterilize before each reuse
• Check adjustment mechanism functionality before use
• Careful adjustment during procedure
• Regular maintenance of adjustment mechanism recommended