User's Manual

PADECG User Manual Safety Guidance
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WARNING
16. Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
17. 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 configuration
shall comply with the valid version of the standard IEC/EN 60601-1. 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. If in doubt, consult our
technical service department or your local distributor.
18. Connecting any accessory (such as external printer) or other device (such as the
computer) to this system 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.
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. You are recommended to purchase the iOS tablet from the manufacturer. Otherwise,
the manufacturer will not be held responsible for the maintenance of the hardware,
operating system and other accessories.
21. 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.
22. Connecting to other devices may decrease the antistatic gradation of the system
during operation.
23. Make sure that there is no intense electromagnetic interference source around when
using the wireless system of PADECG. Furthermore, Keep a unobstructed distance of
at most 3 meters between DX12(iOS) Transmitter and the iOS tablet.