User's Manual

PADECG User Manual Safety Guidance
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WARNING
24. Do not open the battery cover of DX12(iOS) Transmitter when using the wireless
system of PADECG.
25. The iOS tablet shall comply with the valid version of the standard IEC 60950 and be
used outside the patient environment (at least 2 meters away from the patient). The
iOS tablet shall be charged outside the patient environment, and no operations are
permitted during the charging.
26. The device shall not be serviced or maintained while in use with a patient.
27. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC information.
28. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
29. 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.
30. Assembly of the ECG workstation and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
31. Check the gain and speed of the report thoroughly when confirming diagnosis.
32. The device is MR unsafe. It is not intended for use in an MRI environment.
33. 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.