Simulator,gynecological examination

GENERAL DESCRIPTION
Gynecological examination simulator.

INTENDED USE
Training of gynaecological examination and procedures.

TECHNICAL SPECIFICATION
Anatomically accurate adult female torso with abdomen, outer genitalia and reproductive organs.
With set of uteri models with external uterine abnormalities.
With cervixes with cervical abnormalities.
Light complexion.
Material:
Free from any hazardous material.
Features, enable the examination of:
Normal cervix.
Cervical pathology.
Normal uterus.
Abnormal uterus.
Gravid uterus (five-months foetus).
Ectopic pregnancy.
Fallopian tube obstruction.
IUD insertion.

SUPPLIED WITH:
Instructions for use including cleaning and disinfection in English, French and Spanish.
Carrying case/bag.

ESTIMATED LIFE SPAN
5 years.

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:
0 - 40°C / 90% relative humidity.
Operating conditions:
10 to 40 °C, 90% relative humidity.

WEIGHT AND VOLUME (Packaged)
Weight: 10300.00 gr.
Volume: 70.00 dm³.

PACKAGING:
One (1) unit in a single 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.