Huntleigh Healthcare Limited Huntleigh Diagnostic Products Division SF1US 사용자 설명서
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Speci
fi ca
tions
9.6 Directives and Standards Compliance*
European Directives:
The Sonicaid™ Freedom complies with the essential requirements of the
Medical Devices Directive (93/42/EEC) with amendments by 2007/42/EC and
the Radio and Telecommunications Terminal Equipment Directive (1999/5EU).
Medical Devices Directive (93/42/EEC) with amendments by 2007/42/EC and
the Radio and Telecommunications Terminal Equipment Directive (1999/5EU).
Standards:
Safety
IEC/UL/CSA/EN 60601-1 (Second Edition)
IEC/ANSI/AAMI/CSA/EN60601-1 (Third Edition)
EN60601-1-6:2010, IEC60601-2-37:2007
IEC/ANSI/AAMI/CSA/EN60601-1 (Third Edition)
EN60601-1-6:2010, IEC60601-2-37:2007
Electromagnetic
Compatibility
Compatibility
EN60601-1-2:2007
FCC 47 Part 15 Subpart B
FCC 47 Part 15 Subpart B
Radio
ETSI EN 300 220-2: V2.3.1 (2009-12)
ETSI EN 301 489-1 V1.9.2 (2011-09)
ETSI EN 301 489-3 V1.6.1 (2013-06)
FCC 47 CFR Part 15 Subpart C and Part 95; Subpart H
(WMTS), RSS-210
ETSI EN 301 489-1 V1.9.2 (2011-09)
ETSI EN 301 489-3 V1.6.1 (2013-06)
FCC 47 CFR Part 15 Subpart C and Part 95; Subpart H
(WMTS), RSS-210
Labelling
BS EN15223-1:2012
9.7 Recommended Consumables & Accessories*
WARNING: Use only recommended accessories/consumables
listed in this manual.
listed in this manual.
Item
PN
Aquasonic Gel 5ltr container (each)
ACC-1300-0154
Aquasonic Gel (box of 12 x 250ml)
ACC3
Ultrasonic Gel (box 12 x 60ml tubes)
ACC24
Latex free Reusable transducer belts (pair)
ACC-MI1136
Transducer Clips
ACC-OBS-051
Ultrasound Transducer
ACC-OBS-052
TOCO Transducer
ACC- OBS-053
Transducer Sleeve
ACC-OBS-054
Mounting Bracket (To mount the Receiver to an
FM800E Monitor)
FM800E Monitor)
ACC-OBS-050
Service Manual
778345
*This list is not fully comprehensive