Intuitive User Interface

An intuitive user interface, custom sample types, and intelligent sample sequencing make sample analysis as easy as two taps of the screen. Custom sample types allow users to save personal settings for automatic population of configuration information as well as preferred onboard dilutions and cell inspection settings. Intelligent sample sequencing automatically indexes and assigns a unique number to each sample. A 10.6 inch touchscreen display with onboard digital keyboard eliminates the need for additional peripherals. Quick navigation icons make it possible to reach the most common functions with a single touch of the screen. A notification header at the top of the user interface provides instant access to date and time, pending events, reagent status, and onboard training tutorials.

Automated maintenance

No maintenance is required beyond reagent pack replacements. All fluid path maintenance is performed automatically utilizing cleaning solutions contained within the reagent pack to ensure maximum uptime.

High-capacity, cartridge-based reagent management system

FAST CDV reagent cartridges incorporate RFID technology for auto-recognition of pack installation as well as logging the installation date, time, lot number, expiration date, and quantity of tests available. Reagent packs have a use life of more than 500 samples and up to 60 days once installed.

Full network capabilities

FAST CDV has a multitude of options for data transmission and IT data integrity. Both raw data and images can be sent to user-defined network locations on your existing network. As an OPC-compliant device, a custom OPC server coupled with FAST CDV can add an additional level of encryption while also enabling bi-directional communication. Windows Active Directory is used to simplify user account management and user profiles.

Specifications
Physical Dimensions
Width: 17.5”, Depth: 21.5”, Height: 16.5”

Parameter Linear Range
Measurement range: 50,000 cells/mL to 140,000,000 cells/mL.
This range is accomplished by user-selectable onboard dilutions performed by the analyzer.
No external/manual dilutions are required. User selectable dilution ratios:
Ratio 1:1 0.10 to 35.00 million cells/mL
Ratio 1:2 0.20 to 70.00 million cells/mL
Ratio:1:4 0.40 to 140.00 million cells/mL

Viability Range
0 to 100%

Live Cell Diameter Range
4 to 70 μm

Accuracy Specifications Summary

Units of Measure and Resolution

Analysis Time Requirements
The dual flow path, synchronized design of the Fast CDV analyzer processes samples in the following times:
Time to complete first sample: Less than 130 seconds
Time to process subsequent results (in queue samples): Less than 70 seconds

General Safety
IEC 61010-1:2001
EN 61000-4-2 Electrostatic Discharge
EN 61000-4-3 Radiated Immunity
EN 61000-4-8 Magnetic Field
21 CFR Part 11 Compliant

Though not a Medical Device, the Fast CDV is designed to maintain compliance with cybersecurity requirements outlined in Content for Premarket Submissions for Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff October 2, 2014.