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Vi-CELL MetaFLEX

Fast, Low Sample Volume, Reliable

Measuring samples as small as 65 uL and returning results in just 35 seconds, our new Vi-CELL MetaFLEX™ bioanalyte analyzer evaluates pH, pO2, pCO2, glucose, lactate, electrolytes and more. With less maintenance, more reliability and a surprisingly small footprint, it’s a sophisticated research solution that profiles test samples quickly, easily and accurately—keeping your test cell cultures in balance, viable and growing.

Vi-CELL MetaFLEX is available in selected geographies. Please check with your Beckman Coulter representative for availability.

Overview

R&D, QC and Manufacturing Applications

Ideal for micro to large scale cell culture applications, the Vi-CELL MetaFLEX is designed for rapid and accurate Bioanalyte analysis.

Analyzer Performance

Measuring System
Sample volume (all parameters) 65 μL
Measuring time (all parameters) 35 sec*
Cycle time 60 sec*
Throughput 44 samples / per hour*
Average uptime 23.5 hours / per day**

* May vary during startup
** May vary during startup; 2.5 min for system calibration is the longest activity

Sensor Cassette
In-use lifetime 30 days (or until max number of tests)
Shelf life 4 months
Storage temperature 2-8° C / 35-46° F
Automatic QC Yes
Number of tests 300
 
Solution Pack
In-use lifetime 30 days (or until solution pack is empty)
Shelf life 4 months
Storage temperature 2-25° C / 35-77° F
 

Quality Management

Automatic quality management system

 
  • 3 dedicated QC solutions
  • Automatic detection and correction of failures
  • Continuous system and analysis checks
  • Air detection
  • Automatic lockout of parameter that fails QC
  • Customizable QC schedule

Instrument Qualification

 
  • IQ/OQ

Measured Parameters

Type Parameter Units Range of indication
pH pH pH scale 6.3 - 8.0
Cell Culture Gas pCO2 mmHg; Torr 5 - 250
kPa 0.67 - 33.3
pO2 mmHg; Torr 0 - 800
kPa 0 - 107
Electrolyte cK+ mmol/L 0.5 - 25
meq/L 0.5 - 25
cNa+ mmol/L 7 - 350
meq/L 7 - 350
cCa2+ mmol/L 0.1 - 9.99
meq/L 0.2 - 19.98
mg/dL 0.4 - 40.04
cCl- mmol/L 7 - 350
meq/L 7 - 350
Metabolite cGlu mmol/L 0 - 60
mg/dL 0 - 1081
g/L 0 - 10.81
cLac mmol/L –0.1 - 31
meq/L –0.1 - 31
mg/dL –1 - 279
g/L -1 - 2.79

The Range of indication for a parameter is the range within which the analyzer is physically capable of measuring.

Regulatory Compliance

Establishing a strong partnership.

21 CFR Part 11

The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the Food and Drug Administration (FDA) to define the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. Since analytical instrument systems such as the Vi-CELL MetaFLEX generate electronic records, these systems must facilitate compliance with the Electronic Records Rule. The Vi-CELL MetaFLEX features the following key system components to facilitate 21 CFR 11 compliance:

  • Sample results log: 2000
  • Activity log: 5000
  • Calibration adjustment log: 1000
  • Data secured by password protection
  • Electronic signature capability
  • Secure user sign-on
  • 8 user level permissions
  • Administrative configuration tools

Hardware, Software and More

Hardware

 

Computer specifications

  • Processor Intel Celeron® M 600 MHz with 512K L2 Cache
  • 1 GB RAM
  • 2 GB SolidState storage
  • 8.4” color TFT-LCD, resolution 800 × 600 SVGA Touch screen
  • 4” thermal-sensitive printer

Inlet

  • Left/right hand operation
  • Position for syringe as well as capillary and test tube
  • Aspiration from capillary without adapter
  • Aspiration time 5 seconds

Interface

  • Built-in barcode reader for operator & sampler ID
    • Accepted codes: UPC/EAN, Code 128, Code 39, Code 93, I 2 of 5, Discrete 2 of 5, Codabar and more
  • Serial interface RS232 with power for external barcode reader
  • 3 USB connections
  • Optional external keyboard
  • Optional external mouse
  • Optional external barcode reader
 

Software

 

Software platform

  • Windows® XP Embedded
  • Sybase® SQL Anywhere

Data capacity

  • Sample results log: 2000
  • Activity log: 5000
  • Calibration adjustment log: 1000
  • Data secured by password protection
  • 8 different user profiles
  • Unlimited ID access verification
  • Printer display options
  • Auto print (on/off)

Security and QA features

  • Advanced planning of replacement and QC schedules
  • Optional automatic QC at startup and after replacements
  • Customizable QC and calibration schedule

Communication

  • HIS/LIS communication
  • High-level protocols:
    • ASTM
    • HL7
    • POCT1-A
  • Low-level serial protocols:
    • ASTM 1381-91
    • E1394-91
    • Serial RAW
  • Low-level network protocols:
    • TCP/IP
 

Additional Information

 

Dimensions

  • Height
45 cm 17.7 in
  • Width
25 cm 9.8 in
  • Depth
29 cm 11.4 in
  • Weight
11 kg 24.4 lbs

Other

  • Startup time
1.5 hours average (less than 4 hours)
  • Operating environment
15 - 32° C / 59 - 89.6° F, 20 - 80% RH
  • Altitude correction
Up to 4000 m / 13,124 feet above sea level
  • Power
100 - 240 V; 50 - 60 Hz; 250 VAC
  • Thermostat control
Sensor cassette: 37 ± 0.15° C / 98.6 ± 32.27° F

Oximetry: 37 ± 0.30° C / 98.6 ± 32.54° F

Webinars & Symposiums

  • Optimizing Quality Control Electronic Records for 21 CFR Part 11 Compliance

    Tony Harrison Senior Marketing Manager, Beckman Coulter

    Click to play  

    The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures for Quality Control testing and manual transcription of the test results...

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