Intended use: Anatomically accurate full sized adult female lower torso with pelvic cavity and spine. Full term newborn life-size manikin with smooth, soft skull with fontanelles for realistic vacuum delivery.
Light or neutral complexion.
Material and construction
Latex-free construction
Manufactured from medical-grade silicone rubber and/or high-quality synthetic polymers
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.
Functional Features.
The simulator shall support training in the following procedures and scenarios:
- Normal vaginal delivery.
- Cesarean section delivery with simulated incision areaIntrauterine assessment and manipulation of the fetus.
- Breech presentations, including: Complete breech; Frank breech; Footling breech
Fetal head assessment, including palpation of fontanelles.
Placental conditions, including: Placenta previa (partial or total)
Umbilical cord and placenta delivery
Umbilical cord prolapseLeopold’s maneuvers
Compatibility with vacuum-assisted delivery techniques (preferred).
Simulation of episiotomy procedures (preferred).
Additional obstetric scenarios or features may be included.
Supplied with
Instructions for use, including:
Assembly
Operation
Cleaning and disinfectionInstructions provided in:English; French; Spanish.
Replacement or additional umbilical cord(s).
Simulation blood and/or lubrication made from safe, non-hazardous materials.
Carrying or storage bag suitable for transport.
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.
Minimum warranty period: 2 years.
Product shelf life (if applicable): to be specified by manufacturer. Expected 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.
Light or neutral complexion.
Material and construction
Latex-free construction
Manufactured from medical-grade silicone rubber and/or high-quality synthetic polymers
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.
Functional Features.
The simulator shall support training in the following procedures and scenarios:
- Normal vaginal delivery.
- Cesarean section delivery with simulated incision areaIntrauterine assessment and manipulation of the fetus.
- Breech presentations, including: Complete breech; Frank breech; Footling breech
Fetal head assessment, including palpation of fontanelles.
Placental conditions, including: Placenta previa (partial or total)
Umbilical cord and placenta delivery
Umbilical cord prolapseLeopold’s maneuvers
Compatibility with vacuum-assisted delivery techniques (preferred).
Simulation of episiotomy procedures (preferred).
Additional obstetric scenarios or features may be included.
Supplied with
Instructions for use, including:
Assembly
Operation
Cleaning and disinfectionInstructions provided in:English; French; Spanish.
Replacement or additional umbilical cord(s).
Simulation blood and/or lubrication made from safe, non-hazardous materials.
Carrying or storage bag suitable for transport.
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.
Minimum warranty period: 2 years.
Product shelf life (if applicable): to be specified by manufacturer. Expected 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 | $592.05 |
