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10.24 Electromagnetic Compatibility
Changes or modifications to this equipment not expressly approved by MAGNAMED may cause EMC
problems with this equipment. Contact MAGNAMED for technical assistance.
This equipment has been designed and tested to comply with the applicable EMC standards as
described below:
•
Immunity: IEC 60601-1-2
•
Emission: CISPR11 (Group 1
– Class A)
•
Approvals: OS / IEC 60601-1
This equipment has been designed and tested to meet the following essential requirements: deliver volume
within alarm limits or generate alarm condition; FiO
2
monitoring; generate PEEP alarm conditions when PEEP
is above or below the alarm limit; monitor expired volume; alarm condition to indicate when the electrical
voltage has fallen below what is necessary to maintain normal operation; alarm condition to indicate when the
battery charge is near the end; technical alarm condition to indicate failure of the air and oxygen network;
limiting the reverse flow between the gas port to values below 100 mL/h; ensure the accuracy of the oxygen
level within the specified range.
•
Use of mobile phones or other radio-frequency (RF) emitting equipment near the
system may cause unexpected or adverse results. Monitor operation if there are
sources of radiofrequency emission in the vicinity.
•
Use of other electrical equipment in or near the system may cause interference. Before
use on the patient, you should check that the equipment functions normally in the set
configuration.
•
The use of this adjacent equipment or other equipment shall be avoided as it may result
in improper operation. If this is necessary, this and other equipment shall be observed
to verify that they are operating normally.
•
The use of accessories, transducers, and cables other than those specified or provided
by Magnamed may result in high electromagnetic emissions or reduced
Storage Conditions
Temperature
-40 to 70 °C
Humidity
15 to 95 %, non-condensing