|
Material: |
|
|
Housing/box: |
Transparent polyurethane |
|
Filter: |
filtering membrane: Hydropobic polypropylene microfiber |
|
|
moisture exchange: Hydroscopic cellulose |
|
Luer cap : |
polypropylene |
|
Housing/box: |
Rigid with two ports designed to accept 15mm and 15 mm size tubing and connection. |
|
|
- allows viewing secretions |
|
|
- standard connection: 15M, 15F and 8.5F luer port |
|
|
Compressive volume (dead space) 9 - 10ml |
|
Heat and moister exchanger (HME) |
- Temperature output 30.2 |
|
|
- Moisture output: 27.7mg/L of water |
|
Hydrophobic Filter |
- Hygroscopic cellulose membrane: small pore size membrane providing adequate filtration over longer period of time. |
|
|
- Electrostatic filtration principle which relies on natural electrostatic interactions to remove particles. |
|
|
- water repellent under high pressures (up to 60cmH2O) |
|
|
- Bacterial (BFE) and viral (VFE) filtration efficiency of 99.99 %. |
|
|
- Filtering surface/ area: 9 to 10cm2 |
|
|
- Moisture exchange surface: > 150 cm2 |
|
|
|
|
Resistance to flow: |
- At 5L/min 0.7cm H2O |
|
|
- At 7.5L/min 1.2cm H2O |
|
|
- At 10L/min 1.9 cm H2O |
|
Sampling/capnograph port: |
Luer lock, to measure gas/agents concentration positioned on the anaesthetic breathing system side |
|
Sterilised by : |
Ethylene oxide (EO) |
|
Unit presentation: |
Sterile for single use, in a sealed sachet |
|
Packaging: |
Individual sterilized peel-packssachet made of paper and/or plastic, and multinational instruction of use in on dispenser box |
|
Protective packaging: |
carton |
|
Labelling |
Unit presentation/dispenser box to be clearly marked with Manufacturer name, addressee, expiry date, batch number, manufacturer ref Number, CE+ notify body Nr. |
|
|
Dispenser and transport box same label as above + qty per dispenser, storage information |
|
Quality requirement : |
Comply with Medical Device Directive 93/42/EEC, Annexes II.3 6V (Class Risk IIa) |