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Xstrahl 150 - Intended Use (of Equipment); Intended Function (of Document); Document Amendment Table

Xstrahl 150
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150_OPMAN_GB Version 10 © Xstrahl Ltd. All Rights Reserved
15/01/2020
vi
Intended Use (of
equipment)
Xstrahl® (100, 150, 200 and 300) X-Ray Therapy Systems are
intended to be used for radiation treatment of superficial skin
disorders, boney metastases and diseases of the skin, as determined
by a licensed medical practitioner where the system is being used.
They are intended to be used for single or fractionated treatment
(dose or time depending on system). Treatment should always be
determined by a licensed medical practitioner in the jurisdiction
where the system is being 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, 16/4/14).
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

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