Use Instructions
iSE Series Electrocardiograph User Manual Introduction
provided by medical electrical equipment complying with IEC/EN 60601-1,
and
b) Outside the patient environment, the level of safety appropriate for
non-medical electrical equipment complying with other IEC or ISO safety
standards.
19. All the accessories connected to system must be installed outside the patient
vicinity, if they do not meet the requirement of IEC/EN 60601-1.
20. If multiple instruments are connected to a patient, the sum of the leakage
currents may exceed the limits given in the IEC/EN 60601-1 and may pose a
safety hazard. Consult your service personnel.
21.Connecting to other devices may decrease the antistatic gradation of the
system during operation.
22.Make sure that there is no intense electromagnetic interference source around
when using the wireless system of iSE.
23. The device shall not be serviced or maintained while in use with a patient.
24. The medical electrical equipment needs to be installed and put into service
according to Appendix 2
EMC information
.
25.Portable and mobile RF communications equipment can affect medical
electrical equipment, refer to the recommended separation distances provided
in Appendix 2
EMC Information
.
26. The equipment should not be used adjacent to or stacked with other equipment,
refer to the recommended separation distances provided in Appendix 2
EMC
Information
.
27.Assembly of the ECG workstation and modifications during actual service life
shall be evaluated based on the requirements of IEC60601-1.
28.Check the gain and speed of the report thoroughly when confirming diagnosis.
29.Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason make sure that all external devices
operated in the vicinity of the device comply with the relevant EMC
requirements. X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic radiation.
30. The electrocardiograph should be placed on a flat surface or EDAN’s trolley.
Avoid it dropping down to cause strong shock.
31.This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions:
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