Safety Information Regarding Electromagnetic Compatibility - NDD EasyOne Pro Operator's Manual

Safety information
False diagnosis
Network connection
Patient health
hazard and false
diagnosis
2.3

Safety information regarding electromagnetic compatibility

Influence by HF
surgical equipment
Portable wireless
communications
equipment
Increased emissions
or decreased
immunity
Proximity to other
equipment
Operator's Manual V5.0 • EasyOne Pro/LAB Rev. 05
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Non-original respiratory tubes can cause measurement error and false results.
You must only use spirette respiratory tubes by the manufacturer ndd to assure
accuracy, long-life, and full warranty coverage.
List of order numbers and accessories for EasyOne Pro/LAB, 136
Connection of EasyOne Pro/LAB to an IT network that includes other equip-
ment could result in previously unidentified risks to patients, operators, or
third parties.
Subsequent changes to the IT network could introduce new risks and require
additional analysis.
Changes to the IT network include:
• changes in the IT network configuration,
• connection of additional items to the IT network,
• disconnecting items from the IT network,
• update of equipment connected to the IT network, and
• upgrade of equipment connected to the IT network.
It is your responsibility to identify, analyze, evaluate, and control these risks.
IEC 80001-1:2010 provides guidance to address these risks.
EasyOne Pro/LAB measures and presents data reflecting a patient's physio-
logical condition. When reviewed by a qualified physician or clinician, this
data can be useful in determining a diagnosis. However, the data should not
be used as sole means for determining a patient's diagnosis.
Electrical devices with a high RF power output during intended use (e.g. High
frequency (HF) surgical equipment) should not be operated in parallel with
EasyOne Pro/LAB.
Portable wireless communications equipment such as wireless home network
devices, mobile phones, cordless telephones and their base stations, walkie-
talkies, etc. can affect EasyOne Pro/LAB.
Keep a distance of at least 30 cm (12 inches) to any part of EasyOne Pro/LAB.
Accessories, transducers, and cables other than those specified by the manu-
facturer or replacement parts for internal components may result in increased
emissions or decreased immunity of EasyOne Pro/LAB.
EasyOne Pro/LAB should not be used adjacent to or stacked with other equip-
ment.
Should close proximity or stacking be unavoidable, however, the configura-
tion in which it is used needs to be watched closely to ensure that the equip-
ment is functioning normally.
 See Appendix
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