Type 1810 or Type 1800? Two versions, two regulatory frameworks

The EBA 200 name covers different regulatory versions. This article focuses on the EBA 200 MD Type 1810, a Class IIa medical device under the MDR. EBA 200 Type 1800 is the IVD version under the IVDR.

The difference is not higher performance. It is the manufacturer-defined intended purpose and the workflow for which the device is placed on the market. Always verify the type number when purchasing and documenting the device.

Technical data of Type 1810

Why the MD version matters in autologous blood processing

PRP and PRF workflows process blood outside the body and obtain a blood fraction for subsequent use. Device selection therefore depends on the intended purpose defined by the manufacturer.

In Germany, Section 4 of the Medical Devices Operator Ordinance requires medical devices to be operated according to their intended purpose and manufacturer information. This does not replace the assessment of the tube or PRP/PRF preparation system.

E4413 rotor: Why tube dimensions and effective radius matter

For Type 1810, Hettich documents the E4413 eight-place fixed-angle rotor at 33°. The current product presentation states 8 × 10 ml, while broader Hettich documents contain capacity information that is not fully consistent. For a specific tube, use the E4413 rotor table, outer diameter, tube length, adapters and the tube manufacturer’s approval.

The effective radius is not identical for every vessel. Depending on the vessel configuration, the E4413 documentation includes values around 67 mm and 86 mm. That radius is required for converting between RPM and RCF.

RCF instead of RPM: only the g-force can be transferred meaningfully

RCF describes the relative centrifugal acceleration acting on the sample. RPM only describes rotor speed. Without the rotor radius, an RPM value cannot be transferred to another centrifuge.

RCF reference for E4413 at 67 mm and 86 mm

These are calculated reference values, not PRP or PRF protocols.

PRP with the EBA 200 MD: system-specific, not a universal recipe

PRP systems differ in anticoagulant, separation gel, tube geometry, fill volume and centrifugation workflow. There is therefore no universal “PRP setting” for the EBA 200 MD.

Single-spin and double-spin are different preparation strategies. The intended strategy is defined by the relevant system; the number of spins alone does not establish the quality of the resulting PRP.

Document as well

• tube/system and lot
• target RCF and run time
• rotor and effective radius
• loading and balancing
• braking/deceleration profile if specified by the system

From the system protocol to the device setting: Vi PRP-PRO

For Vi PRP-PRO, a system-specific reference protocol of 1,200 × g for 7 minutes is documented. This value belongs to the tube system, not to the centrifuge.

At an effective radius of 86 mm, 1,200 × g corresponds to approximately 3,530 rpm. At 67 mm it would require about 4,000 rpm. The actual tube radius in the E4413 is therefore essential.

PRF: centrifugation is only one part of the workflow

PRF systems generally operate without anticoagulant. The interval between blood collection, filling and centrifuge start therefore becomes a relevant process parameter. Tube material, surface, rotor geometry, RCF, run time and deceleration may also matter.

Published values for i-PRF, A-PRF or other PRF variants describe specific study configurations. They are not manufacturer-approved EBA 200 MD protocols.

PRF protocols from the literature: examples, not EBA 200 MD settings

The following values describe defined study configurations. They are included for scientific context and are not manufacturer-approved settings for the EBA 200 MD or for another tube system.

Manufacturer-backed, calculated, literature-based or unsupported?

For SOPs and training, it should be obvious what status each number has. This avoids mixing manufacturer instructions with literature values or internal calculations.

Example of a traceable protocol overview

Moving from another centrifuge: what can be transferred?

The intended RCF and run time of a validated system protocol may be the starting point. RPM must be recalculated using the effective radius of the new rotor.

Tube dimensions, rotor approval, loading, brake profile and all manufacturer instructions must also be checked. A mathematically equivalent g-force does not by itself prove full system compatibility.

What is transferable when changing centrifuges?

Seven common errors in PRP/PRF centrifugation

Most errors result from mixing device specifications, tube-system protocols and literature values rather than from the centrifuge itself.

Common errors

• copying RPM from another centrifuge
• using the maximum radius for every tube
• confusing Type 1800 with Type 1810
• checking only nominal ml capacity instead of dimensions
• failing to document loading and balance
• presenting a literature protocol as manufacturer approval
• ignoring braking profile and the defined system workflow

Where the EBA 200 MD fits – and where its limits remain

The EBA 200 MD is therefore a technical platform for defined centrifugation workflows. Suitability for a specific PRP or PRF system depends on intended purpose, tube approval and process parameters together.

Strengths

• MDR medical device Type 1810 with documented intended purpose
• E4413 fixed-angle rotor with 8 positions
• up to 6,000 rpm and 3,461 × g
• RCF/RPM conversion using a documented radius
• compact footprint for practice and clinic

Limits

• no manufacturer-defined universal PRP/PRF preset
• tube compatibility must be assessed individually
• fixed-angle rather than swing-out rotor
• no active refrigeration
• throughput limited to 8 rotor positions