Inactive
Notice ID:W81K00-Q-0027
06-AG-PX1000-US-T3 Aerogen Pro-X Controller Kit (Tier 3) and 06-AG-AS3200 Nebulizer, Aerogen Solo, micropump, intermittent and continuous, single patient use, operates in-line must be compatible with ...
06-AG-PX1000-US-T3 Aerogen Pro-X Controller Kit (Tier 3) and 06-AG-AS3200 Nebulizer, Aerogen Solo, micropump, intermittent and continuous, single patient use, operates in-line must be compatible with Aerogen system. Minimum Clinical Performance Requirements - Intermittent and continuous nebulization - Single patient use - Used on or off ofventilator or other posititve pressure breathing assistance Source Considerations - Power Soure: FRIWO (AG-AP1040-US) AC/DC adapter (input 100 to 240 VAC 50- 60 Hz, output 9V) or internal rechargeable battery (4.8 V nominal output) - Power Consumption: <8 Watts (charging), 2.0 Watts (nebulizing) Biomedical Tech Considerations - Operator manual Certifications - Controller circuitry provides 4 kilovolt patient isolation and complies with IEC/EN 60601-1 - Certified by TUV with respect to electric shock, fire and mechanical hazards