
PRO ECG Recorder - User Manual
DIR 80012763 Ver. F 6 / 26
Patient and Operational Safety
The cardiograph isolates all connections to the patient from electrical ground and all other
conductive circuits in the cardiograph. This reduces the possibility of hazardous currents
passing from the cardiograph through the patient’s heart to ground. To ensure the patient’s
safety and your own please observe the following:
When integrating CardioPerfect devices with non-medical rated equipment, such as a
computer, the addition of an additional protective earth ground or the use of a medically
approved isolation transformer is required for compliance to the IEC 60601-1-1 Medical
System Safety Standard.
Any system components (e.g. treadmill, personal computer, ergo meter) that require to be
connected to an outlet socket shall use only grounded power cords (three-wire power cords
with grounded plugs). Also make sure the outlet accepts the plug and is grounded. Never
adapt a grounded plug to fit an ungrounded outlet by removing the ground prong or ground
clip.
Do not connect Multiple Portable Socket Outlets (MPSO’s) or extension cords to the system.
Do not connect items which are not part of the system. The use of multiple portable socket
outlets and other non-medical electrical equipment poses a safety hazard. Refer to the
Medical System Safety Standard IEC 60601-1 for the requirements of such attachments.
Multiple portable outlet sockets shall not be placed on the floor. Multiple portable outlet
sockets or extension cord shall not be connected to the system. Do not connect items which
are not part of the system. The use of multiple (non-) medical electrical equipment connected
to the same patient may pose a safety hazard due to the summation of leakage currents from
each instrument. Any combination of (non-) medical electrical equipment should be evaluated
by local safety personnel before put into service. Multiple portable outlet sockets use without
an isolation transformer is disapproved unless casual access for additional equipment is
impeded or prevented.
Accessories
Use of accessories other than those recommended by Welch Allyn may compromise product
performance. The Welch Allyn warranty can only be honored if you use Welch Allyn approved
accessories and replacement parts.
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