Ortoalresa Digtor 22 Col Benchtop Centrifuge for Adipose Tissue Concentration
| Brand | Ortoalresa |
|---|---|
| Origin | Spain |
| Model | Digtor 22 Col |
| Type | Benchtop Centrifuge |
| Maximum Speed | 3000 rpm |
| Maximum RCF | 1801 × g |
| Maximum Capacity | 4 × 60 mL |
| Dimensions (W×D×H) | 540 × 650 × 400 mm |
| Noise Level | <60 dB(A) |
| Motor | Brushless Induction Motor |
| Compliance | EN 61010-1, EN 61010-2-020, EN 61326-1, EN 61326-2-6, EN 61010-2-010, EU Directives 2011/65/EU, 2012/19/EU, 2014/30/EU, 2014/35/EU, 98/79/EC |
Overview
The Ortoalresa Digtor 22 Col is a CE-certified benchtop centrifuge engineered specifically for adipose tissue processing in clinical and translational research settings. Designed using Couette-flow sedimentation principles optimized for low-density lipid-phase separation, it delivers precise, reproducible concentration of stromal vascular fraction (SVF) and adipose-derived stem cells (ADSCs) from lipoaspirates. Its operational envelope—3000 rpm (1801 × g) with 4 × 60 mL capacity—is calibrated to preserve cell viability and minimize mechanical shear during the 5-minute concentration cycle required for autologous fat grafting protocols. Developed over three decades of European medical device engineering, the Digtor 22 Col integrates ISO 13485-aligned manufacturing rigor with laboratory-grade safety architecture, making it suitable for GLP-compliant workflows in aesthetic surgery units, regenerative medicine labs, and certified tissue processing facilities.
Key Features
- Microprocessor-controlled operation with TFT color touchscreen interface visible from ≥3 m distance; displays real-time RPM, RCF, elapsed time, acceleration/deceleration profiles (PCBS), and imbalance detection (ULS).
- Programmable speed increments in 10 rpm / 10 × g steps; dual-mode timer (countdown or count-up) with 1 s resolution, adjustable from 1 min to 99 h.
- Progressive Control Braking System (PCBS): 175 selectable acceleration/deceleration ramps to prevent post-centrifugation sample resuspension and maintain layer integrity.
- Unbalance Location System (ULS): Graphically identifies the exact rotor position causing imbalance, enabling rapid corrective action without manual rotor inspection.
- 40 programmable memory slots with password protection; automatic rotor recognition; brushless induction motor for zero-maintenance operation and extended service life.
- Integrated safety architecture: dual electric lid lock, emergency mechanical release, lid-drop protection, calibration port, and stainless-steel centrifuge chamber compatible with autoclaving (121°C, 2 bar).
- Forced-air cooling system mitigates temperature rise during prolonged runs; auto-shutdown after 8 h idle (configurable disable option).
Sample Compatibility & Compliance
The Digtor 22 Col accommodates standard conical polypropylene tubes (up to 60 mL) and is validated for use with FDA-cleared adipose processing kits (e.g., Celution®, Puregraft®). Its rotor geometry supports both native lipoaspirate and enzymatically digested suspensions. All contact surfaces—including rotors, adapters, and chamber liners—are autoclavable per ISO 17665-1, ensuring compliance with AATB and FACT-JACIE standards for human tissue handling. The unit conforms to IEC 61010-1 (safety of laboratory equipment) and IEC 61326-1 (EMC requirements), and meets essential requirements under Directive 98/79/EC (IVDR) for in vitro diagnostic ancillary devices used in cell therapy preparation.
Software & Data Management
While the Digtor 22 Col operates as a standalone instrument, its RS-232 and USB interfaces support bidirectional communication with LIMS and electronic lab notebooks (ELN). Audit trails—including user ID, timestamp, program number, final RCF, run duration, and error logs—are retained in non-volatile memory and exportable in CSV format. Optional PC software enables remote parameter validation, firmware updates, and generation of 21 CFR Part 11–compliant electronic records when deployed in GMP-regulated environments. All configuration changes require authenticated login, and critical parameters (e.g., max speed, timer limits) are protected by hierarchical access levels.
Applications
- Clinical adipose tissue concentration for autologous fat transfer in reconstructive and aesthetic surgery.
- Isolation of stromal vascular fraction (SVF) prior to flow cytometry, colony-forming unit assays, or expansion culture.
- Pre-analytical processing of lipoaspirates for metabolomic profiling, extracellular vesicle isolation, or RNA extraction.
- Bench-scale optimization of centrifugation protocols in regenerative medicine R&D laboratories.
- Standardized sedimentation of low-density biological emulsions where thermal stability and minimal shear are critical.
FAQ
Is the Digtor 22 Col compliant with FDA 21 CFR Part 11 for electronic records?
Yes—when used with optional validated PC software and configured with user authentication, audit trail logging, and electronic signature capability, it supports Part 11 compliance in regulated clinical trial settings.
Can rotors be sterilized in an autoclave?
All standard rotors and adapters are constructed from medical-grade stainless steel (AISI 316) and rated for repeated autoclaving at 121°C, 2 bar, per ISO 17665-1.
What safety certifications does the unit hold?
It carries full CE marking under the Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), RoHS (2011/65/EU), WEEE (2012/19/EU), and IVDR (98/79/EC); certified to EN 61010-1 and EN 61010-2-020.
Does the centrifuge support variable-angle or swing-out rotor configurations?
The Digtor 22 Col is supplied with a fixed-angle rotor optimized for adipose phase separation; swing-out configurations are not available for this model due to RCF and dwell-time constraints inherent to fat concentration protocols.
How is imbalance detected and managed during operation?
The ULS continuously monitors vibration harmonics and triangulates the source tube position on the display screen, triggering immediate deceleration and visual/audible alerts before reaching unsafe thresholds.
