Hettich ROTOLAVIT II Cell Washing Centrifuge
| Brand | Hettich |
|---|---|
| Origin | Germany |
| Model | ROTOLAVIT II |
| Instrument Type | Benchtop Centrifuge |
| Speed Range | 0–3,500 rpm |
| Max RCF | 1,438 × g |
| Rotor Radius | 105 mm |
| Capacity | 24 × standard tubes (10 × 75 mm or 12 × 75 mm) |
| Timer Range | 1 sec – 9 min 59 sec |
| Dimensions (H×W×D) | 330 × 480 × 280 mm |
| Power Supply | 200–240 V AC, 50–60 Hz |
| Compliance | IEC 61010-1, EN 61326-1, CE-marked for in vitro diagnostic use |
Overview
The Hettich ROTOLAVIT II is a purpose-engineered benchtop cell washing centrifuge designed specifically for routine immunohematology and clinical transfusion workflows. Operating on the principle of low-speed sedimentation under controlled gravitational force (RCF), it enables reproducible pelleting and resuspension of red blood cells (RBCs), white blood cells (WBCs), and bacterial suspensions without inducing hemolysis or membrane damage. Its fixed-angle horizontal rotor configuration ensures uniform sample distribution during wash cycles—critical for antigen-antibody interaction integrity in crossmatching, antibody screening, identification, and tuberculin (TB) skin test preparation. Unlike general-purpose centrifuges, the ROTOLAVIT II integrates process-specific timing logic, programmable wash sequences, and real-time saline level monitoring to support GLP-compliant manual and semi-automated blood bank protocols.
Key Features
- Touchscreen interface with intuitive icon-based navigation and storage for up to 24 user-defined wash programs—each configurable with precise time, speed, and acceleration/deceleration profiles.
- Dedicated saline-level sensor with audible and visual alert when wash solution reservoir is depleted, preventing incomplete cell resuspension and ensuring assay validity.
- Compact footprint (330 × 480 × 280 mm) optimized for laminar flow hoods, blood bank workstations, and ISO Class 5 cleanroom environments.
- Fixed horizontal rotor with dual tube carriers accommodating either 12 × 10 × 75 mm or 24 × 12 × 75 mm standard glass or polypropylene tubes—compatible with common blood bank collection and reagent tubes.
- Low-noise brushless motor and precision-balanced rotor assembly delivering long-term mechanical stability at 3,500 rpm (1,438 × g at 105 mm radius), with <±1% speed accuracy across operating range.
- Compliance with IEC 61010-1 (safety) and EN 61326-1 (EMC) standards; CE-marked for in vitro diagnostic (IVD) use per Regulation (EU) 2017/746 (IVDR).
Sample Compatibility & Compliance
The ROTOLAVIT II is validated for processing human whole blood, packed RBCs, washed RBC suspensions, and Mycobacterium tuberculosis antigen preparations per CLSI EP12-A2 and AABB Technical Manual guidelines. Tube compatibility includes standard 10 × 75 mm and 12 × 75 mm round-bottom polystyrene or borosilicate glass tubes used in indirect antiglobulin tests (IAT), direct antiglobulin tests (DAT), and enzyme-linked immunoassays (ELISA) sample prep. All operational parameters—including maximum RCF, dwell time, and rotor inertia—are aligned with ASTM E2915-20 (standard practice for validation of centrifugal separation processes) and support audit readiness for CAP, COLA, and Joint Commission inspections. The device does not require calibration certificates for routine use but supports traceable performance verification via optional external tachometer and RCF validation kits.
Software & Data Management
While the ROTOLAVIT II operates as a standalone instrument without network connectivity, its embedded firmware logs all executed runs—including program ID, start/stop timestamps, actual rpm, RCF, duration, and error flags—in non-volatile memory (retention >10 years). Audit trail data can be exported manually via USB port in CSV format for integration into LIMS or QMS platforms. Firmware versioning follows ISO 13485:2016 requirements, with documented change control and backward-compatible updates available through Hettich’s authorized service network. The system supports 21 CFR Part 11–compliant electronic signatures when paired with validated third-party middleware for electronic record archiving.
Applications
- Red blood cell washing prior to antiglobulin testing in blood bank crossmatches and antibody identification panels.
- Preparation of standardized RBC suspensions for automated or manual serological assays (e.g., gel card, solid-phase, microplate methods).
- Saline replacement and pellet resuspension in TB antigen dilution series for Mantoux test reagent preparation.
- Cell pellet recovery in microbiology workflows involving slow-growing organisms requiring gentle sedimentation.
- QC/QA procedures in reference laboratories performing proficiency testing for immunohematology accreditation (e.g., CAP BB-30000 series).
FAQ
What is the minimum and maximum centrifugation time supported by the ROTOLAVIT II?
The timer is adjustable from 1 second to 9 minutes and 59 seconds in 1-second increments.
Does the ROTOLAVIT II support rotor autoclaving or chemical sterilization?
The horizontal rotor assembly is constructed from anodized aluminum alloy and is compatible with 70% ethanol wipe-down and low-temperature hydrogen peroxide vapor (HPV) decontamination; autoclaving is not recommended.
Can the device be integrated into a laboratory automation system?
No native RS-232, Ethernet, or LIS interface is provided; however, discrete I/O signals (start/stop/error) are available via optional relay module for basic PLC-level integration.
Is the ROTOLAVIT II suitable for washing platelet concentrates?
No—it is engineered exclusively for RBC and bacterial suspension washing; platelet washing requires higher RCF control and temperature regulation not offered by this model.
What documentation is supplied for regulatory compliance in FDA-regulated labs?
Each unit ships with Declaration of Conformity (DoC), Factory Test Report, User Manual (EN/DE/FR/ES), and IVDR technical file summary—fully traceable to serial number and firmware revision.
