Specifications
| Platform | APC Instruments |
| Performance | ISO 21501-4 unit-to-unit accuracy & reproducibility |
| Industry Standards | ISO 21501-4 , 21 CFR Part 11, ISO 14644-1:2015, FCC, CE |
| Light Source | Helium neon laser |
| Particle Size Analysis Range | 0.1 - 5 μm / 0.1 - 5 μm |
| Coincidence Loss | % at 1,765,000 particles/m3 (per ISO 21501-4 method) |
| Sample Volume | 5 µm |
| Throughput | 28.32 L per minute |
| Interfaces & Protocols | RS232, RS485, 802.11 b/g Wireless, 802.3 Ethernet, USB Client (v1.1) & USB Host (v1.1) interfaces, Modbus TCP, Modbus RTU, Serial FX |
| Data Storage | 5000 samples |
| Reporting | EU GMP (2015), ISO 146441-1.2015, FS209E, BS5295, ISO 14644-1:1999 |
| Battery | Lithium ion smart battery (rechargeable, ejectable & hot-swappable) |
| Battery Operating Time | 3 hours (minimum) |
| Battery Recharge Time | 6.75 hours (minimum) - 10 hours (maximum) |
| Pump Type | Air vacuum, rated for continuous use |
| Zero Count | ISO 21501-4 & JIS B 9921 (1 count or less in 5 minutes; 95% Upper Confidence Limit) |
| Counting Efficiency | 50% at 0.1 μm (100% for particles > 0.15 μm per ISO 21501-4 & JIS B 9921) |
| Count Alarms, Display & Cycles | User-defined alarm counts, Raw counts: N/CF, N/CM, N/L in cumulative or differential mode |
| Label Locations | ID: 0 to 999; NAME: Alphanumeric (appears on printout) |
| Environmental Conditions | Indoor Environment |
| Temperature Range | Storage temperature range: -40°C to 50°C, Operating temperature range: 0°C to 40°C |
| Humidity Restrictions | 10%-90% relative humidity (non-condensing) |
| Power Requirements | 24 VDC, 3.2 A with 100-240 VAC, 50/60 Hz adapter (included in ship kit) |
| Operating System | Windows® CE |
| Software | Simply Paperless Secure PDF Option |
| Resolution | 320 x 240 |
| Display | Color 1/4 VGA TFT touch screen |
| Operating Modes | Semi-automated, manual, controlled by operator |
| Autoclavable | No |
| Nonpyrogenic | Yes |
| Weight | 15.9 kg (without battery) |
| Width | 33 cm / 13 in |
| Depth | 56 cm / 22 in |
| Height | 23 cm / 9.1 in |
| Color | Silver |
| Package Quantity | 1 |
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.