User's Manual

Page 88
any operator settings or stored data, and shall continue to perform its intended function as
described in the ACCOMPANYING DOCUMENTS .
l When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD,
the ME EQUIPMENT shall continue to perform its intended function and maintain
ESSENTIAL PERFORMANCE..
l PATIENT CABLES and TRANSDUCER cables are exempt from this requirement.
<ISO80601-2-61> SpO2
l ME EQUIPMENT shall comply with subclasses 6.2.1.10 of IEC60601-1-2:2007 and shall
continue to provide basic safety and essential performance.
l No permanent degradation or unrecoverable loss of function, due to damage of ME
EQUIPMENT or software, or loss of data shall be observed at any IMMUNITY TEST
LEVEL.
l Operation within the specified measurement accuracy limits (SpO2=90±5%, SpO2_PR=60
±3bpm) or generation of a technical alarm condition.
l In the event of disruption during IMMUNITY tests of IEC60601-1-2 6.2.2, 6.2.4, 6.2.5 and
6.2.7 may show temporary degradation. Within 30 s the ME EQUIPMENT shall resume
normal operation in the previous operating mode, without loss of any operator settings or
stored data, and shall continue to perform its intended function.
This equipment complies with EN 60601-1-2: 2007. However, if portable transmitter or wireless
LAN equipment is used extremely nearby, the electromagnetic influence may largely exceed the
compliance level and may cause unexpected phenomenon such as noise interference on the
waveform, etc.
This equipment should be used in a location specified by each medical institution.
If any unexpected noise interference on the waveform or failure to the peripheral device occurs,
stop using the equipment and follow the instruction of the technical engineer.
The following is the information relating to EMC (Electromagnetic Compatibility).
(When using this equipment, verify that it is used within the environment specified below.)
Compliance to the Electromagnetic Emissions
The DS-101 is intended for use in the electromagnetic environment specified below. The
customer or the user of the DS-101 System should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Emission Test Compliance Electromagnetic Environment - Guidance
RF Emissions
EN 55011
Group 1
The DS-101 uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment
RF Emissions
CISPR 11 Class B
Class B
The DS-101 System is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network which supplies buildings
used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
Flicker Emissions
Complies