Sun Nuclear MapCHECK 3 - Preface; Intended Use; Description; Quality and Regulatory Systems

Preface iii
Preface
Intended Use
Model 1178 MapCHECK 3 is a two-dimensional (2D) radiotherapy beam dosimetry QA system
intended for the measurement of radiation dose distributions for the purpose of comparison with
a simulated dose distribution in the same phantom geometry as calculated by the treatment
planning system (TPS).
CAUTION: Federal law restricts this device to sale by or on the order of a qualified
radiation therapy professional, such as a medical dosimetrist, medical physicist, or
radiation oncologist for use in radiation oncology.
Description
The MapCHECK
®
3 device contains an array of 1,527 SunPoint
®
2 Diode Detectors that measure
ionizing radiation to simulate patient structure during delivery of a treatment plan dose. The SNC
Patient™ software displays the MapCHECK 3 measurement and compares the results against the
imported treatment plan.
For detailed SNC Patient softwar
e instructions, see the SNC Patient online Help or the SNC Patient
Software Reference Guide, available on the Sun Nuclear Support website (see Support Website
on page 15).
Quality and Regulatory Systems
Sun Nuclear meets worldwide standards, including ISO 13485, FDA 21 CFR 820 Quality System
Regulations, Health Canada's Medical Device Regulations, the European Medical Device Directive
93/42/EEC, and all other relevant country regulations. Sun Nuclear is certified and authorized to
affix the CE mark on products for marketing and distribution in the Member States of the European
Union.
Sun Nuclear’s quality systems registrar and European Not
ified Body for Class II medical products
is BSI. Sun Nuclear’s Class I medical products are listed in Europe with the Competent Authority
of Germany.
Sun Nuclear Corporation is an ISO 13485 certified
company.
Health and Safety Information
• Use only the power supply that is provided with the device; it is a medical grade power
supply.
• Never pull on a cable to disconnect it. Alwa
ys grasp the plug or connector.
• The device is not intended to be used in an oxygen rich environment.
• Do not operate the device in any strong magnetic fields (i.e., MRI).
For instructions to report health or safety related concerns, see Reporting Health or Safety Related
Issues or Concerns on page 24.
WARNING: To avoid risk of electric shock, this equipment must only be connected to
a supply mains with protective earth (ground).