SYMBYX PDCare - Intended Operator and Responsibilities; Operator Responsibilities

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6.16 Intended OPERATOR
Ordinary operator
- An OPERATOR who is medically trained and instructed in the use of the device, and who uses the device in a
day-to-day practice. The OPERATOR performs treatments on PATIENTS.
PATIENT operator
- An OPERATOR who is instructed by, and under the guidance of, an ordinary OPERATOR in how to perform self-
treatment. The ordinary operator shall ensure that the patient operator applies the device in accordance with its
intended use and the accompanying documents. The PATIENT becomes the OPERATOR.
ORDINARY operator education and knowledge:
- Medically trained in a relevant profession (physiotherapist, chiropractor, osteopath, nurse, etc.);
- Educated in the use of the device and competent to make a diagnosis;
- Literate;
- Able to follow the instructions for use and the accompanying documents; and
- Understands hygiene and sanitary control procedures.
PATIENT operator education and knowledge:
- Able to follow the instructions and guidance from an ORDINARY operator;
- Literate;
- Able to follow the instructions for use and the accompanying documents; and
- Understands hygiene and sanitary control procedures.
6.17 Operator responsibilities
It is recommended that every device is under the care of only one person/operator who is well acquainted with its use and functions.
The responsible person for the device should;
§ Read and understand the accompanying documents.
§ Keep or store the accompanying documents.
§ Make sure the accompanying documents and instructions for use are easily accessible when needed.
§ Make sure that he/she is well acquainted with the device before use.
§ Ensure that the device is used in accordance with its intended use, as well as in accordance with the accompanying
documents (user manual).
§ Be responsible for safe storage and transport of the device.