Specifications
(continued)
Operational Conditions
Operating:
Temperature: 10° C (50° F) to 35° C (95° F)
Relative Humidity: 30% to 90%
Atmospheric Pressure: 80 (23.6 in. Hg) to
106 kPa (31.3 in. Hg)
10°C
35°C
30%
90%
106 kPa
80 kPa
Storage:
Temperature: -10° C (14° F) to 55° C (131° F).
Relative Humidity: 10% to 95% (non-condensing)
Atmospheric Pressure: 70 (20.7 in. Hg) to
106 kPa (31.3 in. Hg)
-10°C
55°C
10%
95%
106 kPa
70 kPa
Transportation:
Temperature: -20° C (-4° F) to 60° C (140° F).
Relative Humidity: 10% to 80% (non-condensing)
Atmospheric Pressure: 50 (14.8 in. Hg) to
106 kPa (31.3 in. Hg)
-20°C
60°C
10%
80%
106 kPa
50 kPa
Disposal
Dispose of the Visutron 900
Touch
in accordance with local regulations. The Visutron 900
Touch
con-
tains no hazardous materials.
Software Revision
The software version is located in the Service Menu in the Controller, or by contacting Reichert with the
Central Unit serial number.
Classifications
Compliance
The Visutron 900
Touch
complies with:
• IEC 60601-1
• EN 55032:2015
• FCC 47 CFR Part 15 Subpart 2 15.247
• AAMI ES60601-1
• IEC 60601-1-4
• FCC 47 CFR Part 15 Subpart B
• CSA C22.2#60601-1 • IEC 60601-1-2 Edition 4.0
• ISED ICES-003:2016 Ed. 6
• IEC 60601-1-6
• CENELEC EN60601-1
• Radio Equipment Directive (RED)
2014/53/EU
• IEC 62366
• ETSI EN 301 489-1:2017 Ed. V2.1.1
• UL 60601-1
• ETSI EN 301 489-17:2017 Ed. V3.1.1
• CSA C22.2#601.1
• ISO 15004-1
Device Classification
Electrical Protection:
Class I
Ingress Protection Rating:
IP3X (Central Unit and Controller) or IP2X (Phoroptor Head)
Instrument Type (60601-1):
Type B
Operating Mode (60601-1):
Continuous
US FDA:
REF 16241 Class I, 21 CFR 886.1770
REF 16242 Class I, 21 CFR 886.1665 and 886.1770
EU Medical Device Directive: Class I, Rule 12
CAN CMDR:
Class I, Rule 12
76
16243-101 Rev. G
Summary of Contents for VISUTRON 900 Touch
Page 1: ...VISUTRON 900 Touch User s Guide ...
Page 85: ...Notes 85 16243 101 Rev G ...
Page 86: ...Notes 86 16243 101 Rev G ...
Page 87: ...Notes 87 16243 101 Rev G ...
