Ametek Reichert Phoroptor VRx User Manual page 105

Specifications
Environmental:
The environmental conditions are as follows:
Operating:
Temperature: 10° to 35° C (50° to 95° F)
Relative Air Humidity: 30 to 90%
Air Pressure: 80 kPa to 106 kPa
Transportation and Storage:
Temperature: -10° to 55° C (14° to 131° F)
Relative Air Humidity: 10 to 95%
Air Pressure: 70 kPa to 106 kPa
Operation permitted in explosion proof atmosphere only.
Disposal
Dispose of the Phoroptor VRx in accordance with local regulations. The Phoroptor VRx contains no
hazardous materials.
Software Revision
You can obtain the software version by opening up 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
IEC 60601-1-4
IEC 60601-1-2
CENELEC EN60601-1
ETSI EN 301 489-1
ETSI EN 301 489-17
ISO 15004-1
Device Classification
Electrical Protection:
Ingress Protection Rating:
Instrument Type (60601-1):
Operating Mode (60601-1):
US FDA:
EU Medical Device Directive: Class I, Rule 12
CAN CMDR:
16241-101 Rev. D
(continued)
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
55° C
-10° C
95%
10%
106 kPa
70 kPa
105