Analytica AutoStart Infusion System Technical Information Pack

This disc/webpage contains technical information about Analytica's AutoStart Infusion System, compiled for the benefit of biomedical engineers and technicians. It is a work in progress and will be updated as additional information is generated.

USFDA 510(k)

Clearance Letter K092905

ARTG Certificate

Certificate 148892

Third Party Validation Testing

The following test reports were created by US testing firm NAMSA using Validation units built in Sept 2008. These tests are required by ISO 8536-5:2004

Cytotoxicity Study

Pyrogens and bacterial endotoxins

Systemic toxicity

Intracutaneous study

Haemolysis (ASTM)

Sensitisation

Chemical Testing

Internal Validation Testing

Particulate Contamination Testing to ISO 8536-4:2004 Section 6.1

Leak Testing to ISO 8536-4:2004 Section 6.2

Medicine Concentration in the AutoStart® Infusion System following an Automatic Flow Restart Event

Other Items

Example Instruction Card (supplied with each unit)

Trade Show Animation (WMV file)

Sales Brochure