KRISTELLER Specula flat hollow 105x26mm Fig.1

KRISTELLER SPECULUM • FLAT 105x26mm • FIG.1 • CE-CLASS I • ISO 13485:2016

Flat Precision Speculum for Extended Gynecological Diagnostics

The KRISTELLER Flat Speculum Fig.1 (105x26mm) 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 precision design 105x26mm – 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 – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Flat Speculum Fig.1 105x26mm:

• Flat construction for minimal tissue pressure
• Extended dimensions with flat profile
• Optimal visibility during therapeutic procedures
• Ideal for patients with sensitive anatomy
• Perfect for demanding diagnostics and therapy

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:

• Model: KRISTELLER Speculum flat Fig.1
• Dimensions: 105mm length, 26mm width (closed)
• Maximum opening width: 38mm
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Precise locking mechanism
• Blade shape: Flat, extended, 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 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