Trainer,postpartum suturing

GENERAL DESCRIPTION
Postpartum suturing trainer for episiotomy and vaginal tear.

INTENDED USE
Training of postpartum suturing techniques.

TECHNICAL SPECIFICATIONS:
Trainer for suturing of birth injuries after vaginal births.
Soft genital model and realistic texture tissue can be cut and sutured multiple times.
Light complexion.
Features:
Episiotomy (Median and Mediolateral).
Vaginal tears.
Labial tears.
Perineal tears.
Material:
Soft material to enable suturing procedures.
Non-corrodible hinges or joints.
Free from any hazardous material.

SUPPLIED WITH:
Instructions for use including cleaning and disinfection in English, French and Spanish, or QR code for download.

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 - 30°C / 90% relative humidity.

WEIGHT AND VOLUME (Packaged)
Weight: 1000.00 gr.
Volume: 10.00 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.