Kanomax 3000-0C Condensation Particle Counter (CPC)-Based Respirator Fit Tester
| Brand | Kanomax |
|---|---|
| Origin | Liaoning, China |
| Model | 3000-0C |
| Particle Size Range | 0.02–1.0 µm |
| Concentration Range | 0–100,000 particles/cm³ |
| Sample Flow Rate | 100 cm³/min |
| Total Flow Rate | 700 cm³/min |
| Fit Factor Calculation Method | Direct Cout/Cin Ratio |
| Test Agent | Isopropanol (≥99.5% purity) or Ethanol |
| Display | 7-inch TFT color touchscreen |
| Languages | English, Japanese, Chinese, French, Spanish, Portuguese |
| Compliance Standards | OSHA, CSA Z94.4, ANSI/AIHA RP-01, HSE HSG53, GB 19083–2010, GB 2626–2019, GB/T 32610–2016 |
| Data Storage | USB flash drive |
| Communication Interfaces | USB 2.0, Ethernet (10/100BASE-T), Wi-Fi (802.11b/g/n) |
| Software Compatibility | Windows 7/8/10, .NET Framework 3.5 |
| Report Format | Microsoft Excel (.xlsx) |
| Operating Environment | 10–35 °C, 20–85% RH (non-condensing) |
| Storage Conditions | −20–50 °C, 0–85% RH (non-condensing) |
| Power Supply | AC 110–240 V, 50/60 Hz |
| Dimensions (W×H×D) | 208 × 117 × 262 mm |
| Weight | 2.3 kg |
Overview
The Kanomax 3000-0C is a quantitative respirator fit testing instrument engineered for precision, repeatability, and regulatory compliance in occupational health and safety environments. It employs the Condensation Particle Counter (CPC) principle—where ultrafine ambient particles (0.02–1.0 µm) are grown via controlled isopropanol or ethanol vapor condensation and optically counted—to determine real-time particle concentration both outside (Cout) and inside (Cin) the respirator facepiece. The resulting fit factor (FF = Cout/Cin) provides an objective, numerical metric of seal integrity, eliminating subjectivity inherent in qualitative methods such as saccharin or Bitrex® challenge tests. Designed for laboratory-grade accuracy in field-deployable form, the 3000-0C supports full-cycle fit testing protocols aligned with international respiratory protection standards—including OSHA 1910.134, CSA Z94.4, ANSI/AIHA RP-01, UK HSE HSG53, and key Chinese national standards (GB 19083–2010, GB 2626–2019, GB/T 32610–2016). Its compact architecture (2.3 kg, 208 × 117 × 262 mm), integrated 7-inch high-resolution touchscreen, and dual-sampling configuration (ambient + internal) enable rapid setup and execution in clinical, industrial, and emergency response settings.
Key Features
- Condensation Particle Counter (CPC)-based quantification with detection sensitivity down to 0.02 µm particles and dynamic range up to 100,000 particles/cm³
- Direct fit factor calculation using simultaneous external and internal aerosol sampling (Cout/Cin ratio)
- Integrated 7-inch true-color capacitive touchscreen with intuitive graphical interface and six-language support (English, Japanese, Chinese, French, Spanish, Portuguese)
- Dual-flow system: precise 100 cm³/min sample flow for CPC counting; total 700 cm³/min system flow ensuring stable aerosol delivery and minimal pressure drop across test subjects
- Non-invasive test agent delivery using ≥99.5% purity isopropanol or ethanol—eliminating sensory irritation and regulatory restrictions associated with bitterant or sweetener-based qualitative methods
- Modular hardware design supporting interchangeable mask adapters and dedicated test kits for N95, KN95, FFP2, PAPR, SCBA, elastomeric half/full-face respirators, and surgical masks per ISO 13485-aligned configurations
Sample Compatibility & Compliance
The 3000-0C accommodates a broad spectrum of respiratory protective equipment (RPE), including disposable filtering facepiece respirators (e.g., 3M™, Honeywell™, MSA™, Scott™), reusable elastomeric half- and full-facepieces, powered air-purifying respirators (PAPRs), self-contained breathing apparatus (SCBAs), and chemical cartridge respirators. All testing protocols are implemented in strict accordance with globally recognized occupational hygiene frameworks. Built-in firmware includes preconfigured test sequences compliant with OSHA Appendix A (quantitative fit testing), CSA Z94.4 Annex D, ANSI/AIHA RP-01 Section 6.3, and GB 2626–2019 Clause 6.3. The device supports audit-ready documentation required under GLP and GMP-aligned quality systems, with timestamped raw data export and metadata tagging for traceability. While not FDA-cleared as a medical device, its measurement methodology satisfies ISO 16900-1:2015 requirements for quantitative fit testing instrumentation.
Software & Data Management
The Kanomax FitTest Pro software (Windows 7/8/10, .NET Framework 3.5) enables centralized control of up to four 3000-0C units from a single workstation. It supports automated test sequence execution, real-time fit factor visualization, pass/fail threshold assignment per standard (e.g., FF ≥ 100 for N95, FF ≥ 500 for PAPRs), and customizable reporting templates. All test records—including operator ID, subject ID, respirator model, test date/time, environmental conditions (temperature/humidity), and raw particle counts—are exported in native Microsoft Excel (.xlsx) format for integration into enterprise LIMS or EHS management platforms. Data storage occurs locally on removable USB drives with optional encryption; no cloud dependency ensures data sovereignty and HIPAA/FDA 21 CFR Part 11 alignment when configured with user authentication and electronic signature modules.
Applications
The 3000-0C serves critical roles across multiple sectors requiring evidence-based respiratory protection verification. In healthcare facilities, it validates surgical N95 fit for aerosol-generating procedures under GB 19083–2010 and CDC guidelines. Industrial hygienists deploy it for routine fit testing of manufacturing personnel exposed to silica, metal fumes, or organic vapors—ensuring compliance with OSHA Permissible Exposure Limits (PELs). Fire departments use it to certify SCBA seal integrity prior to structural firefighting operations. Contract testing laboratories leverage its multi-unit scalability and standardized reporting for third-party certification against ISO 16900 series requirements. Educational institutions utilize its intuitive interface and bilingual documentation for hands-on training in occupational safety curricula.
FAQ
What particle size range does the 3000-0C detect, and why is this relevant to respirator testing?
The instrument detects particles from 0.02 µm to 1.0 µm—the most penetrating particle size (MPPS) range for most mechanical filter media. This ensures conservative, worst-case assessment of respirator leakage.
Can the 3000-0C be used for both qualitative and quantitative fit testing?
No—it is exclusively a quantitative instrument based on CPC technology. Qualitative methods (e.g., irritant smoke, saccharin) are not supported or required.
Is calibration traceable to NIST or other national metrology institutes?
Yes. Kanomax provides factory calibration certificates traceable to JCSS (Japan Calibration Service System), with optional annual recalibration services available through authorized service centers.
Does the device meet FDA 21 CFR Part 11 requirements for electronic records?
When deployed with FitTest Pro v3.2+ and configured with password-protected user roles, audit trails, and digital signatures, it satisfies core Part 11 criteria for electronic record integrity.
What consumables require periodic replacement?
Isopropanol reagent (≥99.5%), zero-count filters, and CPC saturator wicks—typical service intervals are every 6 months under standard usage (20 tests/day).
