Ecoray HF-525Plus - Essential Performance; Intended Patient Population; Operator Profile; Symbols Marked on HF-525 Plus

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Technical Publication Document NO: SYSTEM-007-ENG (Ver.1.1)
HF-525Plus Installation, Operation and Service Manual
Use in Flammable Atmosphere
Not to be used in presence of flammable an aesthetic gas
2.7 Essential Performance
2.8 Intended Patient Population
2.9 Operator Profile
2.10 Symbols marked on HF-525Plus
ESSENTIAL PERFORMANCE requirements according to IEC 60601-2-54
Accuracy of LOADING FACTORS
Reproducibility of the RADIATION output
Imaging performance
Item
Details
Age
No limitation
Sex
No limitation
Healthy
Except for pregnant women
Except for patients who get an implantable pace makers or implantable
defibrillators transplant.
Nationality
No limitation
Patient state
Not relevant, unless patient is agitated
Item
Details
Age
Age that person can obtain the license of Radiologic Technologist or a
license equal to it.
Sex
No limitation
Nationality
No limitation
Education
Radiologic Technologist or person who has a license equal to it.
Knowledge
Radiologic Technologist or person who has a license equal to it.
Language
Can read and understand English.
Experience
Necessary.
Every operator needs to take training for operating the equipment before
using the equipment.
Permissible
impairments
Corrected visibility is over 0.7 in the decimal number.
To be unimpaired in extremities and trunk
Others
Over 140 cm tall.
Person who can confirm the safety by looking ahead of the equipment
Symbol
Description
EU-Consult instructions for Use: This symbol means read manuals or descriptions
from manufacture.
EU-Warning or Caution:
This symbol indicates hazard.