Path medical Senti, Руководство пользователя

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9 Technical Specifications
This section provides a summary of the most important technical specifications. Further
technical details are described in a separate
Technical Specification document, which can
be downloaded from www.pathme.de/support/.
9.1 General Device Information
Device classification
(93/42/EEC)
Device classification
(MDR Canada)
Class II a
Class II
Application part classification
Application parts
Type BF (body floating)
Headphones, insert earphones, ear probe, tympanometry add-on, ear
coupler cable, bone conductor, electrode cable, patient response button
Ingress protection rating
(IP code)
Handheld: IP30
Desktop: IP40
Applied standards DIN EN ISO 389-1, DIN EN ISO 389-2, DIN EN ISO 389-3, DIN
EN ISO 389-4, DIN EN ISO 389-5, DIN EN ISO 389-8
(transducer calibration)
, DIN EN ISO 10993-1
(biocompatibility)
,
DIN EN ISO 15223-1
(manual)
, DIN EN 60601-1
(electrical
safety)
, DIN EN 60601-1-2
(EMC)
, DIN EN 60601-1-4
(PEMS)
,
DIN EN 60601-1-6
(usability)
, DIN EN 60601-2-40
(AEP
equipment)
, DIN EN 60645-1
(pure-tone audiometry)
, DIN EN
60645-5
(tympanometry)
, DIN EN 60645-6
(OAE)
, DIN EN
60645-7
(ABR)
, DIN EN 62304
(software lifecycle)
9.2 Device Characteristics
Device dimension Handheld: ca. 209 x 98 x 52 mm (8.22 x 3.86 x 2.05’’)
Desktop: ca. 150 x 210 x 45 mm (5.91 x 8.27 x 1.77’’)
Device weight
(including battery pack)
Handheld: ca. 500 g
Desktop: ca. 475 g
Display properties 240 x 320 pixel, graphic LCD
Handheld: 3.5‘‘, Desktop: 5.0‘‘
Maximum power consumption from
battery Handheld: ca. 5 V, 0.4 A = 2 W
Desktop: ca. 4 V, 0.5 A = 2 W
Typical power consumption from
power supply unit during charging Handheld: ca. 9 V, 1.0 A = 9 W
Desktop: ca. 12 V, 0.17 A = 2 W