User's Manual

SE-1515 PC ECG User Manual Safety Guidance
- 4 -
WARNING
27. You should purchase computer, printer, treadmill, ergometer, BP monitor and bar code
reader from the manufacturer. Otherwise, the manufacturer will not be held
responsible for the maintenance of the PC hardware, operating system and other
accessories.
28. 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.
29. Connecting to other devices may decrease the antistatic gradation of the system
during operation.
30. The system shall not be serviced or maintained while in use with a patient.
31. The appliance coupler or mains plug is used as isolation means from supply mains.
Position the ECG workstation in a location where the operator can easily access the
disconnection device.
32. The medical electrical equipment needs to be installed and put into service according
to Appendix 2 EMC information.
33. Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to the recommended separation distances provided in Appendix 2
EMC Information.
34. 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.
35. Assembly of the ECG workstation and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
36. The device is MR unsafe. It is not intended for use in an MRI environment.
37. 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.
1.2.2 General Cautions
CAUTION
1. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5ºC and 40ºC during operation, and it should be kept between -20ºC and
55º C during transportation and storage.
2. Do not use the equipment in a dusty environment with bad ventilation or in the
presence of corrosive.