Fimi Srl 802161 Manual Do Utilizador
12” LCD ProScribe Xper module Atom
3
Safety and EMC approvals
The 12” LCD ProScribe Xper module Atom meets the following medical safety requirements:
DIRECTIVES
• MD – Safety Requirements: 2006/42/EC.
STANDARDS
• MD – Safety Requirements: 2006/42/EC.
STANDARDS
• IEC 60601-1: 1988 + A1:1991 + A2:1995.
• EN 60601-1: 1990 +A1:1993 +A2:1995
• UL60601-1, 1
st
, 2006
• CAN/CSA-C22.2 No. 60601-1-M90, 2005
• IEC 60601-1: 2005
• EN 60601-1: 2007
• ANSI/AAMI ES 60601-1:2005
• CAN/CSA-C22.2 No. 60601-1:2008
The 12” LCD ProScribe Xper module Atom meets the following EMC a Radio requirements
DIRECTIVES
• R&TTE - Radio and Telecommunication Terminal Equipment: 1999/5/EC.
• FCC (Federal Communications Commission).
• IC (Industry Canada).
STANDARDS
EMC and RADIO (standards)
EMC and RADIO (standards)
• EN 60601-1-2
• EN 300 328 V1.6.1 (2004-11).
• EN 301 489-1 V1.8.1 (2008).
• EN 301 489-17 V2.1.1 (2009).
• 47 CFR FCC Part 15 – Subpart B.
• 47 CFR FCC Part 15 – Subpart C.
• RSS-210
RF EXPOSURE (standards)
• MPE (Max. Permissible Exposure): FCC 47 CFR part 15 Subpart 15.255
• EMF (Electromagnetic. Magnetic Field): EN 50392:2004
NOTE:
This equipment / system is intended for use by healthcare professionals only. This equipment / system may cause radio
interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as
reorienting or relocating
the equipment / system or shielding the location.
This equipment / system is intended for use by healthcare professionals only. This equipment / system may cause radio
interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as
reorienting or relocating
the equipment / system or shielding the location.
RF EXPOSURE WARNING
This EUT is in compliance with MPE for general population / uncontrolled exposure limits and it had been tested in accordance
with the measurement methods and procedures specified in FCC 47 CFR § 1.1310 and 2.1091.
To satisfy FCC RF exposure requirements for mobile transmitting devices, a separation distance of 20 cm or more should be
maintained between the antenna of this device and persons during device operation.
To ensure compliance, operations at closer than this distance are not recommended. The antenna used for this transmitter must not
be co-located in conjunction with any other antenna or transmitter.
with the measurement methods and procedures specified in FCC 47 CFR § 1.1310 and 2.1091.
To satisfy FCC RF exposure requirements for mobile transmitting devices, a separation distance of 20 cm or more should be
maintained between the antenna of this device and persons during device operation.
To ensure compliance, operations at closer than this distance are not recommended. The antenna used for this transmitter must not
be co-located in conjunction with any other antenna or transmitter.
NOTE:
Even if this device has been certified according to medical standards requirements, the use of radio devices in specific clinical
environment may interfere or cause the malfunction of some medical equipment. Before using this device in a medical
environment, contact and ask permission to the local hospital authority.
Even if this device has been certified according to medical standards requirements, the use of radio devices in specific clinical
environment may interfere or cause the malfunction of some medical equipment. Before using this device in a medical
environment, contact and ask permission to the local hospital authority.