|Industry Standards||21 CFR Part 11, ISO 14644-1:2015, CE, FCC|
|Particle Size Analysis Range||0.5 - 5 μm|
|Coincidence Loss||10% at 4,000,000 particles/ft³|
|Sample Volume||5 µm|
|Throughput||2.83 L per minute|
|Interfaces & Protocols||USB Client (v1.1), USB Host (v1.1)|
|Data Storage||10,000 records|
|Battery||Lithium Ion (rechargeable) battery|
|Battery Operating Time||10+ hours (typical use) / minimum 5.5 hours (continuous sampling)|
|Battery Recharge Time||3.5 hours|
|Pump Accuracy||±5% Flow Rate|
|Pump Repeatability||±5% Flow Rate|
|Zero Count||Conforms to JIS B9921 (1 count or less in 5 min; 95% UCL)|
|Counting Efficiency||50% at 0.5 µm (100% for particles > 0.75 µm)|
|Count Alarms, Display & Cycles||User-defined alarm counts, Raw counts: N/CF, N/CM, N/L in cumulative or differential mode|
|Label Locations||Alphanμmeric Location Names|
|Environmental Conditions||Indoor Environment|
|Temperature Range||Operating temperature range: 10°C to 40°C, Storage temperature range: -10°C to 50°C|
|Humidity Restrictions||< 95% non-condensing|
|Power Requirements||100-240 VAC, 50/60 Hz, 1.0 A|
|Resolution||320 x 240|
|Display||3.5" high-resolution (320 x 240) color display|
|Operating Modes||Semi-automated, manual, controlled by operator|
|Weight||0.7 kg(1.5 lb)|
|Width||27 cm(10.6 in)|
|Depth||10 cm(3.9 in)|
|Height||5.3 cm(2.1 in)|
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.