Blood-giving set with air vent

GENERAL DESCRIPTION:
Blood-giving set is used for the transfusion of blood and blood products contained in glass bottles (Albumin, IVIG).

TECHNICAL SPECIFICATIONS:
Components:
-Flexible tubing, perforator (spike) with air vent, drip-counter chamber, blood filter, flow regulator, injector port.
-All materials are haemocompatibles
Material:
-Tube: PVC-based material
-Perforator: stainless steel, encased in polyamide or moulded from ABS or POM (polyacetal).
-Air inlet: PVC
-Drip-counting chamber: PVC
-Blood filter: polyamide (fibres of PA) (170-200um)
-Flow regulator: polystyrene, ABS
-Injection port: rubber latex free
Tube:
-Transparent (permits air bubble detection), supple, resistant to kinking.
-Length: approx.: 50cm (set has an overall length of 170cm).
-Ends in a male Luer lock or slip connector, with or without a bung; permits its connection to another intravenous system.
Perforator:
-A hollow device situated at the proximal end of the set; permits the set to be connected to the blood container.
-Comprised of a needle or a tapering tube mounted on a base; ensure a good seal between the set and the blood container.
Sterile and single use
non-pyrogenic
sterilized by ETO or Gamma radiation"

Instructions for use:
Used for the transfusion of blood and blood products contained in glass bottles.
Single use device supplied in sterile packaging, check the integrity of each unit before use, do not use if the packaging is damaged.

Supplied with:
Manufacture's instruction for use
Accessories/ spare parts/consumables

PACKAGING AND LABELLING:
Primary packaging: Unit of use One (1) Blood-giving set in an individual sterilised peel pack with information for use
Secondary packaging: xxx

REGULATION & CONFORMITY REQUIREMENTS:
CE mark conforming to Council Directive 93/42/EEC on Medical Devices
CE certificate (for class IIa, with Notified body number)
Classification: Class IIa (MDD 93/42/EEC)

Safety & product Standards:
Comply with the following standards:
ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
EN ISO 3826-1:2003: Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components — Part 3: Blood bag
systems with integrated features
ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components — Part 2: Graphical
symbols for use on labels and instruction leaflets
ISO 1135-3 Transfusion equipment for medical use -- Part 3: Blood-taking set
ISO 1135-4:2010:Transfusion equipment for medical use — Part 4: Transfusion sets for single use
ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-4:2002+ Amd 1:2006: Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-11: 2006: Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices
containing phthalates

PACKAGING AND LABELLING:

Primary packaging: Unit of use.
One (1) Blood-giving set in an individual sterilised pack: plastic pack or blister paper pack.

Secondary packaging: XXX


INSTRUCTIONS FOR USE:
Blood-giving set is a sterile single use device without air vent used for parenteral administration of blood and blood products.

SAFETY PROCESS:
After use, dispose, collect and destroy through incineration in a controlled environment