Miltenyi Biotec CliniMACS Plus System

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Overview

Function Description
Important Technical Specifications
Usage Features
Maintenance Features

The CliniMACS® Plus System is a medical device designed for the in vitro separation of human cells from heterogeneous cell populations. It leverages magnetic cell separation technology (MACS® Technology) developed by Miltenyi Biotec B.V. & Co. KG. The system is intended for use in combination with CliniMACS Tubing Sets, CliniMACS Reagents, and CliniMACS PBS/EDTA Buffer only.

Function Description

The CliniMACS Plus System automates cell separation procedures. Its key components include an integrated computer, a magnetic separation unit, a peristaltic pump, a liquid sensor, and pinch valves.

The integrated microcomputer controls all electromechanical components and directs the system through standard procedures. The keypad and display guide the operator through set-up and allow monitoring of automatic system operations.

The magnetic separation unit contains a movable permanent magnet and a separation column holder. During separation, magnetically labeled cells are retained in the separation column within the magnetic field, while unlabeled cells pass through. When the magnet is disengaged, the retained cells are released.

The peristaltic pump controls the flow rate through the tubing sets. The liquid sensor monitors fluid flow, automatically advancing the separation program to the next phase upon detecting an empty Cell Preparation Bag. Eleven pinch valves ensure controlled flow of buffer and cell suspension throughout the procedure.

The CliniMACS Plus Software offers various separation programs, including enrichment strategies (e.g., CD34 SELECTION 1/2) and depletion strategies (e.g., DEPLETION 2.1 and DEPLETION 3.1). These programs allow for the enrichment or depletion of specific cell subsets from a mixed cell population. The system operates in a closed and sterile environment.

Important Technical Specifications

Model: CS3
REF: 151-01
Dimensions: Width: 70 cm, Height: 90–140 cm, Depth: 60 cm
Weight: 35 kg
Input voltage: 100–240 VAC (Single phase alternating current)
Power consumption: 350 VA
Power source: An uninterruptible power source (UPS) is recommended (e.g., APC Smart-UPS 1500 VA USB & Serial 230 V or equivalent).
Instrument power inlet: IEC-320-C13. A country-specific power cord is supplied.
Frequency: 50/60 Hz
Fuses: 2× T4A/250V, 5×20 mm (UL and European approvals, acc. to IEC 127-2/III, EN 60127-2/III, DIN 41662).
Operation conditions: +10 °C to +30 °C (+50 °F to +86 °F) with 0% to 85% humidity at an altitude of max. 2000 m. Supply voltage fluctuations up to ±10% of nominal voltage. Transient over-voltages present on mains supply: category II. Rated pollution degree 2. Intended for indoor use only.
Storage conditions: –10 °C to +60 °C (+14 °F to +140 °F) with 0% to 85% humidity, when contained and sealed in the outer packaging provided by the manufacturer.
Software version: 2.4x
Regulatory information: CE-marked medical device (MD 0123), UL Listed (laboratory equipment), conforms to IEC/EN/SN EN 61010-1, UL 61010-1, CAN/CSA-C22.2 No. 61010-1, IEC 60601-1-2, EN 60601-1-2, and Directive 2011/65/EU (RoHS).
Electromagnetic compatibility (EMC): CISPR 11 Group 1, Class A for RF Emissions and Harmonic emissions (IEC 61000-3-2), Complies with Voltage fluctuations/Flicker emissions (IEC 61000-3-3). Immunity tests conform to IEC 60601-1-2 for Electrostatic discharge, Electrical fast transients, Surges, Voltage dips, interruptions, and variations, Rated power frequency magnetic field, Conducted disturbances induced by RF fields, Radiated RF EM fields, and Proximity fields from RF wireless communication equipment.

Usage Features

The CliniMACS Plus System offers a user-friendly interface with a touchscreen display and keypad.

Language Selection: The operator can choose between English, German, French, Spanish, Italian, and Dutch.
Service Menu: Provides access to various programs, including date and time setting, process code inspection, and access to additional separation programs (requires Miltenyi Biotec authorization).
Process Code Inspection: Allows retrieval of process codes from the last 15 separations, useful for tracking and troubleshooting.
Tubing Set Installation: Guided installation of sterile tubing sets, including attachment of bags (Cell Collection Bag, Priming Waste Bag, Buffer Waste Bag, Negative Fraction Bag, Reapplication Bag, Non-Target Cell Bag), insertion of pre-column and separation column, and loading of valves and pump tubing. Visual and auditory prompts assist the operator.
Priming: An automated phase where the tubing set is filled with buffer, circulated through columns, and waste is collected.
Integrity Test: Automated test sequences for both upper and lower parts of the tubing set to check for leaks, ensuring safety and proper function.
Cell Preparation and Magnetic Labeling (STEP 1): Detailed instructions for preparing the leukapheresis product, including dilution, centrifugation, volume adjustment, and incubation with CliniMACS Reagents (e.g., CD34, CD19, TCRα/β-Biotin, Anti-Biotin). This step involves careful handling of bags, use of heat sealers, and orbital rotators.
Start of Instrument and Program Choice (STEP 2): Guides the operator through switching on the instrument, selecting the appropriate separation program (e.g., CD34 SELECTION 1/2, DEPLETION 2.1, DEPLETION 3.1), and entering sample parameters (WBC concentration, percentage of labeled cells, final volume). The system performs material checks to ensure compatibility of tubing sets and reagents.
CliniMACS Plus Separation (STEP 4): Automated cell separation procedure where labeled cells are retained or depleted based on the chosen strategy. Includes column washes, cell release, and collection into specified bags.
Disconnect Bags and Record Process Code: Instructions for safely disconnecting bags after separation and recording process data.
Unload Tubing Set and Shutdown: Guidance for removing the used tubing set and shutting down the instrument.
Analysis of Cells: Emphasizes the importance of analyzing target cells for quality and quantity, including total leukocytes, percentage of positive cells, viability, purity, and recovery.

Maintenance Features

Cleaning: The instrument surface should be cleaned regularly and after each application with an antiseptic solution (e.g., Bacillol® plus or Meliseptol®). It is crucial to clean only when the instrument is switched off and unplugged, avoiding excessive liquid ingress into valves.
Routine Maintenance: The CliniMACS Plus Instrument does not contain operator-serviceable parts. Routine and preventative maintenance, including calibration, should be conducted by the manufacturer’s authorized service personnel at least once a year.
Instrument Disposal: The instrument must be collected separately according to the European directive of waste of electrical and electronic equipment (WEEE) and returned to Miltenyi Biotec for final disposal after cleaning.
Troubleshooting: The manual provides a comprehensive troubleshooting guide for unexpected events, including error messages, issues during loading and priming of the tubing set, pump motor stalls, liquid sensor malfunctions, and problems with cell separation performance. It advises contacting Miltenyi Biotec Technical Support for issues that cannot be resolved by the operator.