SYMBYX PDCare - Responsible Organization and Patient Position; Responsible Organization; Patient Position

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§ Be responsible for educating, instructing and surveying a PATIENT operator.
§ Be responsible for the use of correct eye protection wear (if necessary).
§ Be responsible for contacting the manufacturer or its representative when further education or training is required, as well as
with questions regarding service.
Operator contact with the device
- The operator sits or stands and uses at least one hand to control and operate the device;
- The operator manages the device with dry or normal hand skin condition or with protective gloves; and
- Neither hands nor gloves should have been in contact with any oils, creams, lotions, balms, moisturizers, etc.
§ Oils and creams etc. might damage electrical or mechanical components
§ Oils and creams etc. make the grip slippery. The operator might drop the device
6.18 Responsible organization
The responsible organization should designate the responsibility for the device to one person only (the operator). The responsibilities
the responsible organization has include ensuring that the operator of the device is;
- Educated or trained in the use of the device;
- Well acquainted with the device;
- Familiar with the instructions for use and the accompanying documents; and
- Medically or clinically trained to guide a PATIENT operator.
In addition, the responsibilities incorporate;
- Ensuring the supply of proper and correct eye protection wear (if necessary);
- Ensuring means for technical service or support when needed; and
- Using the device in accordance with local laws, regulations and requirements.
6.19 Patient position
The patient should be sitting, standing or lying down. The patient’s skin must not have been in contact with any oils, creams, lotions,
balms, moisturizers, etc. Oils and creams etc. might damage electrical or mechanical components.
Use with caution in the following circumstances!
Treatment should be avoided or performed under supervision and by medical professionals in the following circumstances:
- In or around the neck region in hyperthyroidism; it has not been observed that laser light can cause direct
damage, but since the thyroid is sensitive to light, it is advised to avoid irradiation over the gland, especially with
large doses;