Owandy Radiology i-max touch 3D, Руководство пользователя

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User Manual - Revision history
NIMXEN020I
Owandy Radiology SAS
Revision history Manual code NIMXEN020I
Rev. Date Page/s Modification description
0 21.12.16 - Document approval
1 15.11.17 from 21 to 23, 33, 43,
44, from 46 to 53,
64, 66, 69, 70,
from 81 to 83
Added 110-120V version information (MET safety
marking).
Added dimensions for wall mounted with floor
support version.
Updated CDTI information.
Added QC Program description.
Added scanning of dental impression and dental
models feature description.
Exam procedure improvement.
Anatomic exposure parameters updated.
Added Warnings in patient positioning.
(Ref. RDM 8480, RDM 8505, RDM 8644, RDM 8655)
2 14.03.18 2, 4, 17, 27, 29, 31,
35, from 47 to 66,
74, 77, 79, 80, 83,
96, 97
Quality control program improvement.
Cybersecurity information added.
Improvement on patient positioning information
(paediatric patient).
Added FOV for 80x80mm collimator.
Added dimensions for floor mounted version
Minor description improvement.
(Ref. RDM 8651, RDM 8742, RDM 8753)
3 20.11.18 9, 12, 13, 19,
from 24 to 26, 40, 47, 48,
51, 52, from 54 to 61,
63, 64, 69, 70,
from 81 to 83,
from 91 to 93, 102,
103, from 107 to 109
FDA approved revision.
Updated "Warnings" paragraph (added pediatric use
information).
Updated "Cybersecurity measures" paragraph.
Updated "Quality assurance program" chapter.
Added "Metal artefact reduction filter (MAR)" chapter.
Emergency button information added.
Error messages update.
(Ref. RDM 8887, RDM 8888)
4 02.07.19 1, 3, 4, 8,
from 14 to 16,
from 23 to 28, 33, 39,
40, 71, 101, 111
Release of extended volumes functionality.
Compliance to IEC60601-1:AM1.
(Ref. RDM 8923, RDM 8994)
5 09.12.19 26, 28, 101
4
20, from 22 to 24
Correction of extended volumes size
Correction of X-ray beam size for mandibular and
maxillary dentition
Introduction of e-IFU symbol and update of the labels
6 19.05.20 from 72 to 73 Correction of item numbers of chin, bite and TMJ
supports
0G 11.01.21 1, 6, 24, 27, 95, 97, 98
19, 20
22, 23
26, 30
46
97, 98
Alignment of exam names in the document
Update of used symbols at paragraph 3.6
Update of labels at paragraph 5.1
Correction of max line apparent resistance from 0.4
to 0.2 ohm and introduction of line voltage regulation
of <3% @ 99V. Added total
filtration ≥ 2,5 mm Al eq.
@ 86 kV ref. IEC 60601-1-3 Par. 7.1 and update of
inherent filtration at chapter 6 (additional filtration
value was removed)
Added new chapter 7
– Removable part list
Added the acquisition mode selection between