Pump,breast,manual,w/access

GENERAL DESCRIPTION
Manually operated breast pump for milk extraction and collection.

INTENDED USE
A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

TECHNICAL SPECIFICATIONS
Including screw-fit, graduated collection bottle with a minimum capacity of 150 ml.
Includes: a cap, screw ring and sealing disk.
Equipped with lever to operate the pump, a valve, and diaphragm.
Allows for complete disassembly.
At a minimum should be able to withstand 5 minutes in boiling water for cleaning.
Ergonomic design for single-handed operation, with swivel lever for smooth milk extraction.
Comes including comfortable breast shield.
Low-force operating lever.
Bottle, pump mechanism, cap and stand: polypropylene, polyethylene or TPE.
Membrane and seal: silicone.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x standard size membrane breast shield.
1 x valve system with swivel handle.
2 x spare valve membranes.
1 collection bottle with cap.
1 x stand.

ESTIMATED LIFE SPAN
Three to five years.

WARRANTY
One year.

ENVIRONMENTAL CONDITIONS
Storage conditions: -20 - 50°C / 20 – 90 % RH.
Operating conditions: 10 - 40°C / 20 - 80% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 500 gr.
Volume: 5.00 dm³.

INSTALLATION / COMMISSIONING REQUIREMENTS
Other than assembling the unit there is no installation or commissioning required.

TRAINING REQUIREMENTS
The user manual provides sufficient user instructions.

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

COMPONENT OF A KIT
No.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

SAFETY AND PRODUCT STANDARDS
- EU-Framework Regulation on materials and articles intended for food contact: (EC) No 1935/2004.
- Commission Regulation (EC) No 2023/2006 on good manufacturing practice (GMP) for materials and articles intended to come into contact with food.
- Commission Regulation (EC) No 10/2011 on plastic materials and articles intended to come in contact with food.
- EN 14350 Child use and care articles - Drinking equipment.
- Swiss Regulation on Food Contact Materials SR 817.023.21 (Bedarfsgegenstände VO) of 23.11.2005, updated 01.05.2017

NOMENCLATURE
GMDN Code: 38477