Intended Use; Indications; General Safety - EmCyte Executive Serie Centrifuge II Manuel D'utilisation

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EXECUTIVE SERIES CENTRIFUGE II OPERATION MANUAL

INTENDED USE

The Executive Series Centrifuge II and the Accelerate Executive Series Centrifuge are intended
exclusively for indoor use and for separating autologous whole blood and bone marrow aspirate in the
EmCyte Component Concentrating System.
The centrifuge may only be operated by trained staff. The operating manual should be read carefully,
regardless of whether or not the individual(s) is familiar with the centrifuge.

INDICATIONS

The Executive Series Centrifuge II and the Accelerate Executive Series Centrifuge systems are used in
conjunction with the EmCyte Component Concentrating System in the safe and rapid preparation of
autologous platelet rich plasma (PRP) from a small sample of blood and/or bone marrow aspirate at
the patient's point of care. Autologous PRP, isolated through the use of the Executive Series Centrifuge
II and the Accelerate Executive Series Centrifuge systems and the EmCyte Component Concentrating
System, can be mixed with autograft and allograft bone prior to application to an orthopedic surgical
site or as deemed necessary by the clinical use requirements.

GENERAL SAFETY

To ensure that the centrifuge is operated in a safe manner, avoiding the hazard of injury to personnel
or damage to material goods, the following safety precautions should be followed at all times:

The centrifuge must only be opened by trained personnel competent in its use.

Never use the centrifuge unless the rotor is properly mounted and secure.

Never open, or attempt to open the lid while the centrifuge rotor is still turning.

Only use original parts for the centrifuge.

Never operate the centrifuge if components are missing or damaged.

If the rotor becomes damaged it must be discontinued and replacement fitted.

Only use EmCyte Concentrating Devices. Make sure that concentrating devices are balanced
with equal volume and weight prior to centrifugation. Follow product IFU.

No changes should be made to the mechanical or electrical components.

The centrifuge has not been manufactured from inert materials or to be explosion proof.

Ensure that it is not operated within an environment, or with materials that makes these a
requirement.

ONLY centrifuge whole blood or bone marrow aspirate in the Executive Series
Centrifuge II and the Accelerate Executive Series Centrifuge.

Do not centrifuge corrosive, radioactive, flammable, or explosive substances. Do not
centrifuge substances prone to react briskly with each other. Should any doubt exist regarding
the suitability of a substance, consult safety personnel or call customer support to comply with
national regulations (refer to World Health Organization: Laboratory Biosafety Manual).

Concentrating device and/or Counter Balance MUST be loaded into the centrifuge OPPOSITE
of each other and with each one containing the same volume. Failing to do so may result in
damage to the centrifuge and/or personnel injury.

In order to prevent damage to the compressor following improper transport, the device may
not be switched on until four hours after setting up.

Please remove the transport safety device and keep it for possible use if the device is
subsequently moved again.

Place the centrifuge on a solid, flat, non-resonant lab bench. The condensation water tray
should be inserted from the side.

The surrounding area must be well ventilated and protected against direct sunlight.
 To ensure that the ventilation of the device is not impaired, a fundamental clearance of 30 cm
to the side and a minimum of 15 cm to the back wall must be maintained.

During centrifugation, according to the recommendations set out in EN 61010-2-020 a safety
clearance of 30 cm must be maintained around the centrifuge within which there are no