Intended use: Anatomical simulator designed for training healthcare personnel in the suturing of birth-related injuries, including episiotomies and vaginal tears, following vaginal childbirth.
Suitable for medical, midwifery, and obstetric skills training programs.
Neutral / Universal complexion
Material and construction: Latex-free construction. Manufactured from medical-grade silicone rubber and/or; alternative plastics may be accepted if specified by the manufacturer.
Materials shall be:
- Durable
- Non-toxic
- Free from hazardous or restricted substance
Any hinges, joints, or movable components shall be:
- Non-corrodible
- Manufactured from materials suitable for repeated training use
Materials used shall allow for safe cleaning and disinfection
Desgin and Functional Features
Soft genital model with realistic tissue texture, designed to withstand multiple cuts and suturing sessions.
Simulates anatomical structures relevant to episiotomy and vaginal tear repair, including:
- Median, mediolateral, and lateral episiotomies
Vaginal tears
Labial tears
Perineal tears
Muscle and skin layers may be sutured separately to simulate layered repair.
Compatibility with advanced childbirth simulators Advanced childbirth simulator (Light, Dark)
The simulator shall support training in:
- Episiotomy repair (median, mediolateral, lateral)
- Repair of vaginal, labial, and perineal tears
- Layered suturing of muscle and skin
- Additional training functions may be included if specified by the manufacturer
Supplied with:
Instructions for use, including:
- Assembly
- Operation
-Cleaning and disinfectionInstructions provided in: English; French; Spanish
Sutures and needles (preferable)
Carrying case or protective cover
Any additional accessories required for full functionality shall be listed
Operating and Environmental Conditions
Storage and transport conditions: Temperature range: approximately 0°C to 50°C
Relative humidity: up to 90%Operating conditions:
Temperature range: approximately 10°C to 40°C
Relative humidity: up to 90
Manufacturer to specify validated environmental limits
Warranty and Lifecycle:
Minimum warranty period: 2 years
Product shelf life (if applicable): to be specified by manufacture. rExpected product lifespan under normal training conditions: to be specified by manufacturer.
Guidance for disposal, recycling, or recovery at end of product life shall be provided in accordance with applicable environmental and waste management regulation
Safety, performance and quality standards
Certified quality management system:
Mandatory: ISO 9001
Preferable: ISO 13485, or good manufacturing practice (GMP) for anatomical models
Risk management ISO 14971 (by analogy)
FSC or Certificate for exportation of the offered product provided by the authority in the manufacturing country.
Compliance with ISO 10993-1 if appropriate
Material safety Declaration: REACH / non-toxic / latex free
Suitable for medical, midwifery, and obstetric skills training programs.
Neutral / Universal complexion
Material and construction: Latex-free construction. Manufactured from medical-grade silicone rubber and/or; alternative plastics may be accepted if specified by the manufacturer.
Materials shall be:
- Durable
- Non-toxic
- Free from hazardous or restricted substance
Any hinges, joints, or movable components shall be:
- Non-corrodible
- Manufactured from materials suitable for repeated training use
Materials used shall allow for safe cleaning and disinfection
Desgin and Functional Features
Soft genital model with realistic tissue texture, designed to withstand multiple cuts and suturing sessions.
Simulates anatomical structures relevant to episiotomy and vaginal tear repair, including:
- Median, mediolateral, and lateral episiotomies
Vaginal tears
Labial tears
Perineal tears
Muscle and skin layers may be sutured separately to simulate layered repair.
Compatibility with advanced childbirth simulators Advanced childbirth simulator (Light, Dark)
The simulator shall support training in:
- Episiotomy repair (median, mediolateral, lateral)
- Repair of vaginal, labial, and perineal tears
- Layered suturing of muscle and skin
- Additional training functions may be included if specified by the manufacturer
Supplied with:
Instructions for use, including:
- Assembly
- Operation
-Cleaning and disinfectionInstructions provided in: English; French; Spanish
Sutures and needles (preferable)
Carrying case or protective cover
Any additional accessories required for full functionality shall be listed
Operating and Environmental Conditions
Storage and transport conditions: Temperature range: approximately 0°C to 50°C
Relative humidity: up to 90%Operating conditions:
Temperature range: approximately 10°C to 40°C
Relative humidity: up to 90
Manufacturer to specify validated environmental limits
Warranty and Lifecycle:
Minimum warranty period: 2 years
Product shelf life (if applicable): to be specified by manufacture. rExpected product lifespan under normal training conditions: to be specified by manufacturer.
Guidance for disposal, recycling, or recovery at end of product life shall be provided in accordance with applicable environmental and waste management regulation
Safety, performance and quality standards
Certified quality management system:
Mandatory: ISO 9001
Preferable: ISO 13485, or good manufacturing practice (GMP) for anatomical models
Risk management ISO 14971 (by analogy)
FSC or Certificate for exportation of the offered product provided by the authority in the manufacturing country.
Compliance with ISO 10993-1 if appropriate
Material safety Declaration: REACH / non-toxic / latex free
| Pack Size | Avg. Price |
|---|---|
| Each | $285.60 |
