Intended use: Simulator intended for training of vascular access and airway management (including intubation) in newborns in clinical and educational settings.Life-size full-term newborn manikin with anatomically realistic proportions and landmarks.
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
Anatomy and Airway
Anatomically realistic head, neck, and upper airway.
Head tilt / chin lift functionality enabling opening of the airway.
Supports oral and nasal airway access.
Skin and Veins
Soft, flexible, and realistic skin texture, allowing visualization of underlying venous structures.
Translucent or semi-translucent skin to facilitate vein identification.
Correct anatomical positioning of the following veins: Jugular; Basilic; Cephalic; Saphenous.
Training Features
Vascular Access
Veins suitable for: Injection; Blood withdrawal; Fluid infusion; Umbilical catheterization and infusion site suitable for neonatal training.
Airway Management
Capability for: Airway suctioning; Oral intubation; Nasal intubation.
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
Simulated blood, made from non-hazardous, safe-to-use materials (minimum one bottle).
Carrying or storage case suitable for transport and protection of the manikin.
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 standardsCertified 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
Anatomy and Airway
Anatomically realistic head, neck, and upper airway.
Head tilt / chin lift functionality enabling opening of the airway.
Supports oral and nasal airway access.
Skin and Veins
Soft, flexible, and realistic skin texture, allowing visualization of underlying venous structures.
Translucent or semi-translucent skin to facilitate vein identification.
Correct anatomical positioning of the following veins: Jugular; Basilic; Cephalic; Saphenous.
Training Features
Vascular Access
Veins suitable for: Injection; Blood withdrawal; Fluid infusion; Umbilical catheterization and infusion site suitable for neonatal training.
Airway Management
Capability for: Airway suctioning; Oral intubation; Nasal intubation.
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
Simulated blood, made from non-hazardous, safe-to-use materials (minimum one bottle).
Carrying or storage case suitable for transport and protection of the manikin.
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 standardsCertified 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 | $450.65 |