Simulator, vacuum delivery

GENERAL DESCRIPTION
Vacuum delivery simulator.

INTENDED USE
Obstetric training in vacuum delivery.

TECHNICAL SPECIFICATIONS:
Obstetrical simulator with focus on vacuum and forceps delivery.
Anatomically accurate full sized adult female lower torso with pelvic cavity and spine.
Full term newborn life-size manikin with umbilical cord.
Additional premature life-size manikin.
Light complexion.
Baby manikins can be filled with water to provide a more life like weight distribution.
Durable, easy to clean and maintain.
Material:
Non-corrodible hinges or joints.
Free from any hazardous material.

SUPPLIED WITH:
Instructions for use including cleaning and disinfection in English. French and Spanish can be provided upon request.
Simulated blood powder.
Extra vulva.
Carry bag.

WARRANTY
Two years.

ENVIRONMENTAL CONDITIONS:
Do not expose the item to extreme variations in temperature, keep in a dry place, away from direct sunlight.
Storage conditions:
16 - 26°C on a (non-condensing) relative humidity free environment.
Operating conditions:
16 - 26°C on a (non-condensing) relative humidity free environment.

WEIGHT AND VOLUME (Packaged)
Weight: 9000.00 gr.
Volume: 80.00 dm³.

PACKAGING:
One (1) unit in a box.

TRAINING REQUIREMENTS
Where staff has experience with these types of devices, no user training will be required.

MAINTENANCE/USER REQUIREMENTS
Other than cleaning in accordance with manufactures instructions there are not specific maintenance requirements.

QUALITY MANAGEMENT SYSTEM
- Supplier is certified for ISO 9001 Quality management systems – Requirements.
- Manufacturer is certified for ISO 9001 Quality management systems.

CLASSIFICATION
This device is not classified as a medical device.