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Sysadvance - Model M Series - Medical Oxygen Generators
SYSADVANCE ´M´ Series Oxygen generators and systems are specially designed to supply Oxygen 93 compliant with European Pharmacopoeia – Oxygen 93 Monograph and are certified according to class IIb European Medical Device aimed at health care facilities, ranging from small clinics to large size hospitals, with operating ICU and OR´s. The Oxygen unit is fully automated and controlled by a PLC.
- ECONOMY - reduction of 90% of Oxygen costs;
- COMFORT - elimination of the logistic and administrative operations;
- CONTINOUS AVAILABILITY - elimination of orders and deliveries;
- SECURITY - low pressure non-cryogenic solution;
- CERTIFICATION
- Certified quality management system according to ISO 13485
- Certified generators and systems according to medical devices directive 93/42/EEC;
- Container and skid-mounted solutions available.
ADVANTAGES OF FULL SYSTEM CERTIFICATION
SYSADVANCE designs and installs Oxygen PSA Generators and Systems to produce according to European Pharmacopoeia Oxygen 93 Monograph.
SYSADVANCE system certification provides health care facilities with oxygen quality and security of supply under Oxygen 93 Monograph requirements.
SYSADVANCE EC Medical Certification comprises generator only or full system*.
Full system certification includes:
- Dimentioning and specification;
- Manufacturing;
- Full test and factory validation including mass spectrometer analysis;
- As-built layout and P&ID;
- Installation, start-up and training;
- On-site validation;
- Certified maintenance program;
- Periodic assessment of gas quality;
- Oxygen monitoring compliance.