Intended use: Anatomical simulator designed for training healthcare personnel in newborn cardiopulmonary resuscitation (CPR), airway management, and basic neonatal life support.Suitable for use in neonatal, pediatric, midwifery, and emergency care 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
Full-term, life-size newborn manikin with realistic anatomical features.
Soft, elastic skin texture and molded hair.
Fully articulated head, neck, and jaw, including tongue.
Head-tilt and chin-lift functionality to enable airway opening.
Realistic skin tone; multiple options acceptable.
The simulator shall support the following minimum training functions:
- Airway and Breathing
- Head-tilt and chin-lift functionality to open the airway.
- Oral and nasal suctioning.
- Endotracheal intubation.
- Assisted ventilation with a realistic chest rise.
Cardiopulmonary Resuscitation (CPR)
- Chest compression and ventilation training with realistic resistance and feedback.
- Ability to withstand a defined number of compression cycles; details to be specified by the manufacturer.
- Preferred equipped with a CPR monitoring or feedback device.
Vascular Access and Injection
- Intravenous injection and transfusion simulation via the arm and the femoral vein.
- Umbilical catheterization and infusion.
- Heel-prick procedures for blood sampling.
Observation and Assessment: Pupil observation functionality.
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.
CPR monitor or feedback device (if applicable)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.
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.
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
Full-term, life-size newborn manikin with realistic anatomical features.
Soft, elastic skin texture and molded hair.
Fully articulated head, neck, and jaw, including tongue.
Head-tilt and chin-lift functionality to enable airway opening.
Realistic skin tone; multiple options acceptable.
The simulator shall support the following minimum training functions:
- Airway and Breathing
- Head-tilt and chin-lift functionality to open the airway.
- Oral and nasal suctioning.
- Endotracheal intubation.
- Assisted ventilation with a realistic chest rise.
Cardiopulmonary Resuscitation (CPR)
- Chest compression and ventilation training with realistic resistance and feedback.
- Ability to withstand a defined number of compression cycles; details to be specified by the manufacturer.
- Preferred equipped with a CPR monitoring or feedback device.
Vascular Access and Injection
- Intravenous injection and transfusion simulation via the arm and the femoral vein.
- Umbilical catheterization and infusion.
- Heel-prick procedures for blood sampling.
Observation and Assessment: Pupil observation functionality.
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.
CPR monitor or feedback device (if applicable)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.
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 | $361.79 |