Precision Amniotome for Controlled Amniotomy in Obstetrics
The BEACHAM Amniotome 26 cm is a medical device of CE class I according to ISO 13485:2016. This precision amniotome with its safe hook design and rounded tip is designed for the controlled rupture of fetal membranes under sterile conditions during obstetric care.
Product Highlights:
✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Directive 93/42/EEC)
✔ Precision amniotome according to Beacham
✔ Rounded, safe hook design
✔ High-quality stainless steel 1.4301 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993
✔ Atraumatic tip for maximum patient safety
✔ Optimal length for safe accessibility
✔ Sterilizable and reusable
Advantages of the Precision Amniotome:
• Safe Hook Design: Specially developed rounded tip minimizes injury risk
• Atraumatic Application: Gentle rupture of fetal membranes without tissue trauma
• Optimal Length: 26 cm for safe accessibility and precise guidance
• Easy Handling: Ergonomic design for controlled application
• Controlled Perforation: Precise rupture of amniotic membrane
Technical Specifications:
• Model: BEACHAM Amniotome
• Total Length: 26 cm
• Hook Design: Rounded, atraumatic, curved
• Material: Stainless Steel 1.4301
• Tip: Blunt rounded, safe
• Design: Ergonomic handle for precise control
• Risk Class: I according to Directive 93/42/EEC
Fields of Application:
• Planned amniotomy during labor
• Rupture of membranes with prolonged latent phase
• Amniotomy for labor induction
• Selective membrane rupture in active labor phase
• Controlled amniotomy under sterile conditions
Special Safety Notes:
• STRICTLY for obstetric specialists only
• Apply only with sufficiently dilated cervix
• Strict sterile technique required
• Check for damage and surface integrity before use
• Use only with engaged fetal head
• Strictly adhere to reprocessing guidelines for reuse
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