About Xstrahl
PHET_OP_GB Version 7 ©2017 Xstrahl Ltd. All rights reserved
12/02/18 | vii
Intended Use (of
equipment)
The Xstrahl RADiant Therapy System is a low energy X-ray system
intended for superficial radiotherapy and surface electronic
brachytherapy treatment of primary malignant epithelial neoplasms
of the skin and keloids.
Typical applications include treatment for Basal Cell Carcinoma,
Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous
Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma,
Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous
Lymphomas (B and T cell) and Keloids.
Treatment
determined by a licensed medical practitioner. Intended to
be used for single or fractionated treatment. Treatment should always
be determined by a licensed medical practitioner in the jurisdiction
where the system is used
Note:
In the United States, Federal law restricts the sale of these
devices, distribution and use by, or on or order of, a licensed
physician.
Intended Function (of
document)
The intended function of this document is to assist the operator in the
safe and correct operation, application and preventative maintenance
of the equipment. The operator is the authority who has the control
of the equipment and the person(s) who operates and works on the
equipment.
Xstrahl recommends that this document is kept with the equipment at
all times.
Document Amendment
Table
Xstrahl, at their discretion, may update sections of this document
after first issue. Updated document amendments will be marked by
an identifying release date which can be found at the bottom of all
document pages (for example, 22/5/14).
It is the responsibility of the operator to update the following
Document Amendment Table as new document amendments are
issued:
Document
No.
Section
Release Date
Authorised By
Содержание RADiant
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