How To Use These Operating Instructions; Symbol Meanings; Intended Use; Remaining Risks - Intra-Lock INTRA-SPIN Manual

1

How to use these operating instructions

• Before using the centrifuge, read the operating instructions and observe them.
• The operating instructions are a part of the device. They must always be kept readily available.
• If the device is set up at a different location, the operating instructions must be provided with it.
2

Symbol meanings

Symbol on the device:
Attention, general hazard area.
Before using the device, make sure you read the operating instructions and observe the safety
information!
Symbol in this document:
Attention, general hazard area.
This symbol refers to safety relevant warnings and indicates possibly dangerous situations.
The non-adherence to these warnings can lead to material damage and injury to personal.
Symbol on the device and in this document:
Beware of biohazard.
Symbol in this document:
This symbol refers to important circumstances.
Symbol on the device and in this document:
Symbol for the separate collection of electric and electronic devices according to the guideline
2002/96/EG (WEEE). The device belongs to Group 8 (medical devices).
Applies in the countries of the European Union, as well as in Norway and Switzerland.
3

Intended use

This device is a medical product (laboratory centrifuge) within the context of the Medical Product Directive 93/42/EEC.
The centrifuge was designed only for the separation of substances or mixtures with a density of no more than 1.2
kg/dm³.
The Intra-Spin TM Centrifuge is intended to be used for the safe and rapid separation of autologous blood samples
for the preparation of autologous platelet rich fibrin (PRF). The PRF is used for the preparation of fibrin matrixes
which might be mixed with autograft and/or allograft bone prior to application to a bony defect.
The centrifuge is only meant for this purpose.
Another use or one which goes beyond this, is considered to be non-intended. The company Intra-Lock International,
Inc. is not liable for damage resulting from this.
Observing all information in the operating instructions and complying with the measures described therein is also a
part of the intended use.
If the centrifuge is installed in another device or in a system, the manufacturer of the overall system is responsible for
its safety.
4

Remaining risks

The device is built according to the state-of-the-art and the recognized safety regulations. If used and handled
improperly, there could be life-threatening danger to the user or third parties, or the device could be impaired or there
could be other property damage. The device is only to be used for its intended purpose and only when it is in safe
working condition.
Malfunctions which could affect safety must be corrected immediately.
EN
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