Intended use:Training simulator designed for clinical and educational settings to provide hands-on training in newborn CPR, including basic airway management and assessment of circulation.
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 and elastic skin texture suitable for repeated training use.
Fully articulated head, neck, and jaw, including tongue.
- The simulator shall support the following training functions at minimum:
Airway Management
Head-tilt and chin-lift functionality to open the airway.
Support for positive-pressure ventilation with realistic chest rise.
- Cardiopulmonary Resuscitation (CPR).
- Chest compression training with realistic resistance.
- Ability to withstand a defined number of compression cycles; details to be specified by the manufacturer.
- Circulation Assessment:
Palpable arterial pulse points for training in circulation assessment.
- 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.
Preferably equipped with an electronic CPR monitor; power requirements to be specified if applicable.
Carrying or storage bag
Disposable CPR barrier masks
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 and elastic skin texture suitable for repeated training use.
Fully articulated head, neck, and jaw, including tongue.
- The simulator shall support the following training functions at minimum:
Airway Management
Head-tilt and chin-lift functionality to open the airway.
Support for positive-pressure ventilation with realistic chest rise.
- Cardiopulmonary Resuscitation (CPR).
- Chest compression training with realistic resistance.
- Ability to withstand a defined number of compression cycles; details to be specified by the manufacturer.
- Circulation Assessment:
Palpable arterial pulse points for training in circulation assessment.
- 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.
Preferably equipped with an electronic CPR monitor; power requirements to be specified if applicable.
Carrying or storage bag
Disposable CPR barrier masks
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 | $532.56 |