EDAN iSE-301 User Manual - page 10

SE-301 Series Electrocardiograph User Manual                                 Safety Guidance 

- 4 - 

WARNING 

26. Do not connect any equipment or accessories that are not approved by the 

manufacturer or that are not IEC/EN 60601-1 approved to the electrocardiograph. 

The operation or use of non-approved equipment or accessories with the 

electrocardiograph is not tested or supported, and electrocardiograph operation and 

safety are not guaranteed. 

27. Any non-medical equipment (such as the external printer) is not allowed to be used 

within the patient vicinity (1.5m/6ft.). 

28. Multiple portable socket-outlets shall not be placed on the floor. 

29. Do not use the additional multiple portable socket-outlet or extension cord in the 

medical electrical system, unless it's specified as part of the system by manufacturer. 

And the multiple portable socket-outlets provided with the system shall only be used 

for supplying power to equipment which is intended to form part of the system. 

30. Accessory equipment connected to the analog and digital interfaces must be certified 

according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data 

processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all 

configurations shall comply with the valid version of the standard IEC/EN 60601-1-1. 

Therefore anybody, who connects additional equipment to the signal input or output 

connector to configure a medical system, must make sure that it complies with the 

requirements of the valid version of the system standard IEC/EN 60601-1-1. If in 

doubt, consult our technical service department or your local distributor. 

31. Connecting any accessory (such as external printer) or other device (such as the 

computer) to this electrocardiograph makes a medical system. In that case, 

additional safety measures should be taken during installation of the system, and the 

system shall provide: 

a)  Within the patient environment, a level of safety comparable to that 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. 

32. 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.