Simulator,childbirth,normal,light

GENERAL DESCRIPTION
Simulator for obstetric training in deliveries and early postpartum management. Light complexion.

INTENDED USE
Obstetric training in normal deliveries and early postpartum management.

TECHNICAL SPECIFICATIONS:
Birthing simulator with adult female uterus with cervix landmark.
Full term newborn life-size manikin with palpable.
Light complexion.
Simulation will cover the following obstetric procedures:
- Normal vaginal delivery.
- Breech delivery.
- Assisted delivery: forceps.
- Complete or incomplete placenta delivery and examination.
- Umbilical cord cutting and clamping.
- Suctioning simulation.
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.
- 1 x removable palpable abdominal wall cover for foetus positioning.
- 1 x foetus as specified in general design requirements.
- 1 x placenta with membranes.
- 1 x umbilical cord.
- 2 x umbilical clamps or ties.
- Carrying case/bag.
- Simulation blood (depending on the supplier/model).

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: Temperatures around 20°C, Humidity 40-60% RH.
Operating conditions: Temperatures 15 to 40 °C, Humidity 40 - 60% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 14000.00 gr.
Volume: 220.00 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.