LBL-2019-41-v4 OptoMonitor 3 IFU wTAVI_en Rev 2022-03
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1.6
Cybersecurity
•
OpSens makes no representation of warranty that use of the OptoMonitor complies with
applicable laws and regulations concerning data privacy, security and confidentiality.
OptoMonitor needs to be evaluated as a component of your system as you use, control, process
or transfer patient health information.
•
It is hospital responsibility to ensure proper decommissioning process is followed with regard to
patient information stored on device.
•
Access codes and passwords change frequency should be aligned with local hospital password
policies.
•
To protect the integrity of the device as well as the privacy and security of sensitive information,
the system should be located in an access-controlled environment. Use of Locking password (ref
section 8.6.1) is recommended. Locking delay should be aligned with local hospital password
policies.
•
Access codes and passwords are activated by default. Disabling them is accepting that
unauthorized access can be granted
•
Hospital network should be protected using a firewall and an up-to-date antivirus software tool.
2
COMPLIANCE WITH REGULATORY REQUIREMENTS
2.1
Compliance with Standards and Directives
OptoMonitor 3 complies with the applicable portions of the following standards:
CSA Standards:
CAN/CSA-C22.2 No. 60601-1:2014 CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part
1: General Requirements for Basic Safety and Essential Performance
CAN/CSA C22.2 No.60601-1-6:11 +
AMD1
Medical Electrical Equipment – Part 1-6: General Requirements for
basic safety and essential performance – Collateral Standards:
Usability.
(Adopted IEC 60601-1-6:2010, third edition, 2010-01 + A1:2013 –
edition 3.1 This consolidated version consists of the third edition
(2010) and its amendment 1 (2013-10)).
CAN/CSA C22.2 No.60601-2-34:12 Medical Electrical Equipment – Part 2-34: Particular requirements for
the basic safety and essential performance of invasive blood pressure
monitoring equipment.
ANSI/AAMI Standards:
ANSI/AAMI ES60601-
1:2005/(R)2012, AND C1:2009
AND A2:2010(R)2012
(Consolidated text - edition 3.1)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance (IEC 60601-1:2005+A1:2012, MOD).
IEC60601-1-6 :2010 + A1 :2013
Medical Electrical Equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard:
Usability.