Classifications - Ametek Reichert Phoroptor VRx User Manual

Specifications
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)
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)
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)
Disposal
Dispose of the Phoroptor VRx in accordance with local regulations. The Phoroptor VRx contains 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 Phoroptor VRx complies with:
• IEC 60601-1
• AAMI ES60601-1
• CSA C22.2#60601-1
• IEC 60601-1-6
• IEC 62366
• UL 60601-1
• CSA C22.2#601.1
Device Classification
Electrical Protection:
Ingress Protection Rating:
Instrument Type (60601-1):
Operating Mode (60601-1):
US FDA:
EU Medical Device Directive:
CAN CMDR:
76
(continued)
• IEC 60601-1-4
• IEC 60601-1-2
• CENELEC EN60601-1
• ETSI EN 301 489-1
• ETSI EN 301 489-17
• ISO 15004-1
Class I
IP3X (Central Unit and Controller) or IP2X (Phoroptor Head)
Type B
Continuous
REF 16241 Class I, 21 CFR 886.1770
REF 16242 Class I, 21 CFR 886.1665 and 886.1770
Class I, Rule 12
Class I, Rule 12
35°C
10°C
30%
55°C
-10°C
10%
60°C
-20°C
10%
106 kPa
90%
80 kPa
106 kPa
95%
70 kPa
106 kPa
80%
50 kPa
16241-101 Rev. E