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Safety precautions
1-5
NOTE:
−
The ECG parameter conforms to IEC 60601-2-27 with the exception of Sub-clause
51.103.2: SILENCE/RESET of PHYSIOLOGICAL ALARMS/Sub-clause 51.104.1: Auditory
manifestation of TECHNICAL ALARMS: A new alarm only triggers a visual indication,
not the audible alarm.
−
Refer IEC 60601-2-49 item for monitor’s performance and warnings.
NOTE:
−
The ECG parameter conforms to IEC 60601-2-27 with the exception of Sub-clause
51.103.3.4: New PHYSIOLOGICAL ALARM(s) beginning after activation of SILENCE/
RESET resumed the auditory and visual ALARM manifestations
−
Refer IEC 60601-2-49 items for monitor’s performance and warnings.
NOTE:
−
The ECG parameter conforms to IEC 60601-2-27 with the exception of Sub-clause
51.104: Both non-latched and latched alarms are selectable for technical alarms.
−
Refer IEC 60601-2-49 items for monitor’s performance and warnings.
•
The NIBP parameter conforms to IEC 60601-2-30, EN 1060-1, EN 1060-3 with the
exception of Sub-clause 22.4.1, 51.103 of IEC 60601-2-30 and Sub-clause 5 of EN 1060-1.
NOTE:
−
The NIBP parameter conforms to IEC 60601-2-30 with the exception of Sub- clause
22.4.1: In single fault condition, the functioning independently of the normal
pressure control system does not prevent immediately.
WARNING
Prolonged use and frequent blood pressure determinations can lead to
venous pooling and congestion. Devices that exert pressure on tissue have
been associated with purpura, skin avulsion, compartmental syndrome,
ischemia, and/or neuropathy. To minimize these potential problems,
especially when monitoring at frequent intervals or over extended periods
of time, make sure the cuff is applied appropriately and examine the cuff
site and the limb distal to the cuff regularly for signs of impeded blood flow.
NOTE:
−
The NIBP parameter conforms to IEC 60601-2-30 with the exception of Sub-clause
51.103: Both non-latched and latched alarms are selectable for technical alarms.
−
Refer IEC 60601-2-49 item for monitor’s performance and warnings.
NOTE:
−
The NIBP parameter conforms to EN1060-1 with the exception of Sub-clause 5:
Abbreviations; “Mean” used instead “M” or “MAP”.
−
The word “Mean” is used in monitor instead of “M” or “MAP” as the value for the NIBP
pressure mean average.
WARNING
The clinical practitioner can understand “Mean” is the abbreviation of NIBP
pressure mean average. The B30 monitor is intended for use by qualified
medical personnel only.
•
The alarm systems of the Monitor conform to IEC 60601-1-8 with the exception of Sub-
clause 6.3.3.1a
NOTE:
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