INSTRUCTIONS FOR USE PIN INDEX MEDICAL GAS REGULATOR PAGE 1. SYMBOLS 2. INTENDED USE OF DEVICE 3. TECHNICAL DESCRIPTION 4. WARNINGS 5. INSTRUCTIONS FOR USE 6. CLEANING AND DISINFECTION 7. INSPECTION AND USER CHECKS 8. MAINTENANCE 9. ACCESSORIES AND SPARE PARTS 10.
Medical Device INTENDED USE OF DEVICE There are two main uses for the Meditech range of Medical Gas Regulators. Units fitted with a pressure outlet, typically 4 bar, are used to provide gas to a device which requires an input at this pressure. Primarily, pneumatically powered medical devices such as a ventilator or Demand Valve.
Units are available with both a pressure outlet and a flow outlet and these can be used for either purpose or both simultaneously. TECHNICAL DESCRIPTION This manual refers to B.N.O.S. Meditech 55B and 55SL medical gas regulators with pin index input fittings. 55B Range regulators are designed for mobile use in demanding conditions. The main material of manufacture is brass.
The connectors fitted to the Regulator are designed specifically for this device. If replacements are needed, they must be approved parts supplied by B.N.O.S. Meditech Ltd. The Regulator must not be disassembled when it is under pressure, as serious injury could result.
7.1.2 If contaminated, the Regulator should be cleaned in accordance with Section 6. 7.1.3 If damaged, the Regulator should be withdrawn from service and returned to B.N.O.S. Meditech for assessment and repair. 7.2 USER CHECKS (to be carried out before and after cleaning). Ensure no blockages of the pressure relief valves (frozen in extreme temperature) 7.2.1 Connect the regulator to a suitable Medical Gas cylinder.
B.N.O.S. Meditech Ltd. for assessment and repair. 8. MAINTENANCE 8.1 Maintenance must be carried out on the unit on a five-yearly basis by B.N.O.S. Meditech or engineers certified by B.N.O.S. Meditech. This activity involves dismantling the unit and replacing all internal seals and any components which show significant wear and tear.
We reserve the right to change design without prior notice. 13. APPLICABLE STANDARDS B.N.O.S. Meditech Ltd. is an ISO 13485:2016 certified company. B.N.O.S. Meditech Regulators are supplied in conformity under a quality system to meet Medical Devices Directive 93/42/EEC Regulators are classified as Class IIb Medical Devices.