Intended use:The newborn training simulator intended for use in clinical and educational settings for training in complete newborn care, including but not limited to:
- Basic and advanced newborn handling
- Airway management and resuscitation
- Umbilical cord cutting, clamping, and post-delivery care
Light or neutral 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 anatomically representative newborn manikin with integrated umbilical cord.
Overall size, proportions, and anatomical landmarks suitable for realistic newborn care training.
Realistic facial features including mouth and nostrils suitable for airway management practice.
The simulator shall include the following minimum functional capabilities:
- Airway and Breathing
-Head-tilt and chin-lift functionality enabling airway opening.
- Capability for upper airway suction/aspiration.
- Visible and realistic chest rise during positive pressure ventilation.
Circulation and Heart Activity Assessment
- Simulated heart activity assessable through at least one of the following:
-Palpable umbilical cord pulse beats
- Audible chest heart sounds
Umbilical Cord Care
- Integrated umbilical cord suitable for:
- Cutting
- Clamping or binding
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
One (1) newborn resuscitator with compatible face mask(s); mask sizes to be specified.
One (1) suction device.
One (1) stethoscope.
Two (2) umbilical cord clamps or ties.
Two (2) newborn drying/wrapping sheets.
One (1) newborn head cap.
One (1) transport and/or storage bag.
Transport/storage bag.
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 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
- Basic and advanced newborn handling
- Airway management and resuscitation
- Umbilical cord cutting, clamping, and post-delivery care
Light or neutral 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 anatomically representative newborn manikin with integrated umbilical cord.
Overall size, proportions, and anatomical landmarks suitable for realistic newborn care training.
Realistic facial features including mouth and nostrils suitable for airway management practice.
The simulator shall include the following minimum functional capabilities:
- Airway and Breathing
-Head-tilt and chin-lift functionality enabling airway opening.
- Capability for upper airway suction/aspiration.
- Visible and realistic chest rise during positive pressure ventilation.
Circulation and Heart Activity Assessment
- Simulated heart activity assessable through at least one of the following:
-Palpable umbilical cord pulse beats
- Audible chest heart sounds
Umbilical Cord Care
- Integrated umbilical cord suitable for:
- Cutting
- Clamping or binding
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
One (1) newborn resuscitator with compatible face mask(s); mask sizes to be specified.
One (1) suction device.
One (1) stethoscope.
Two (2) umbilical cord clamps or ties.
Two (2) newborn drying/wrapping sheets.
One (1) newborn head cap.
One (1) transport and/or storage bag.
Transport/storage bag.
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 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 | $448.07 |