KRISTELLER Specula deep 110x18mm Fig.00

KRISTELLER SPECULUM • DEEP-CONCAVE 110x18mm • FIG.00 • CE-CLASS I • ISO 13485:2016

Ultra-Narrow Deep-Concave Speculum for Maximum Sensitivity Gynecological Diagnostics

The KRISTELLER Deep-Concave Speculum Fig.00 (110x18mm) is a medical device of CE class I according to ISO 13485:2016. This ultra-narrow speculum with deep-concave construction was specifically developed for highly sensitive examinations of virginal patients, children and in extreme pain conditions.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I
✔ Ultra-narrow deep-concave design 110x18mm – for maximum sensitivity
✔ High-quality stainless steel 1.4021 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993 – for safe application
✔ Deep-concave blade construction – maximum gentleness with minimal insertion depth
✔ Ultra-narrow configuration – for virginal and pediatric anatomy
✔ Strongly conical blade ends – atraumatic insertion
✔ Micro-precision mechanism – extremely fine locking
✔ Ergonomic micro-grips – for maximum sensitivity
✔ Fully autoclavable – up to 135°C
✔ Sterile packaged – individually for immediate use
✔ Multiple use – reusable after sterilization

Advantages of the KRISTELLER Deep-Concave Speculum Fig.00 110x18mm:

• Deep-concave construction for maximum tissue preservation
• Ultra-narrow for children and virginal patients
• Minimal insertion depth with optimal diagnostic capability
• Specifically for highly anxious and traumatized patients
• Ideal for pediatric gynecology

Fields of Application:

• Pediatric gynecological examinations
• Virginal patients with extremely narrow anatomy
• High-grade vaginismus
• Examinations after sexual violence
• Pediatric and adolescent gynecology
• Psychosomatic-gynecological special examinations
• Diagnostics for congenital malformations

Technical Specifications:

• Model: KRISTELLER Speculum deep-concave Fig.00
• Dimensions: 110mm length, 18mm width (closed)
• Maximum opening width: 22mm
• Special feature: Deep-concave blade construction
• Material: Surgical Steel 1.4021
• Design: Multiple use
• Mechanism: Micro-precision mechanism
• Blade shape: Ultra-narrow, deep-concave, strongly conical
• Surface: High-gloss polished
• Risk Class: I according to MDR 2017/745
• Sterilization: Steam sterilization up to 135°C

Important Safety Information:
• For professionals specialized in pediatric and psychosomatic gynecology only
• Extremely sensitive and trauma-aware examination technique required
• Comprehensive education and explicit consent essential
• Discontinue examination immediately at slightest resistance
• Specifically for use in children and highly traumatized patients