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4. Important information
Batteries
•
This device uses an RTC battery (Mod. CR-2032) and a Lithium Ion battery pack (Mod. BN2012350-
001LPA-01). Both batteries are not user-replaceable. Do not attempt to replace them, contact Barco
authorized repair facilities.
•
Batteries used with this equipment have been tested for compatibility and should only be replaced
with approved parts.
•
The batteries are not designed to be charged by any other electrical source. Charging could generate
gas and internal short-circuiting, leading to distortion, leakage, overheating, explosion, or fire.
Connection of PEMS by network/data coupling to other equipment (for MNA ver-
sion only)
•
Connection of the PEMS to a network/data coupling that includes other equipment could result in
previously unidentified risks to patients, operators or third parties.
•
The responsible organization should identify, analyze, evaluate and control these risks.
•
Subsequent changes to the network/data coupling could introduce new RISKS and require additional
analysis.
•
Changes to the NETWORK/DATA COUPLING include:
- Changes in NETWORK/DATA COUPLING configuration;
- Connection of additional items to the NETWORK/DATA COUPLING;
- Disconnecting items from the NETWORK/DATA COUPLING;
- Update of equipment connected to the NETWORK/DATA COUPLING;
- Upgrade of equipment connected to the NETWORK/DATA COUPLING.
General warnings
•
All devices and complete setup must be tested and validated before taking into operation.
•
At end user application level, it is necessary to foresee a backup unit in case the equipment fails.
•
The enclosure has to be checked upon collision damage; refer to qualified service personnel.
•
Do not connect to the internet before you have installed an anti-virus software and Internet firewall to
protect the Barco User Interface from viruses.
Technical data
•
The equipment is intended for indoor use.
•
The equipment has been designed to be used in landscape orientation.
•
Class II Equipment, according to the type of protection against electric shock.
•
The equipment is not intended to be sterilized.
•
The equipment has no applied parts. The front side of the equipment and the plastic enclosure have
been treated as applied parts however, because they may accidentally be touched by the patient for
a time <1 minute.
This apparatus conforms to:
Safety:
•
IEC 60601-1: 2012 Edition 3.1 (Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance)
•
EN 60601-1: 2006 +A1:2013 (Medical electrical equipment". Part 1: General requirements basic
safety and essential performance)
•
ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - Med.
El. Equip., Part 1: general req. for basic safety and essential performance.
•
CAN/CSA-C22.2 No. 60601-1: 14 Medical Electrical Equipment - Part 1: General Requirements for
Basic Safety and Essential Performance (Harmonized with Ed. 3.1)
EMC:
18
K5902132 (451920612532) MUIP-2112 30/11/2017
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