EDAN SE-601 Series User Manual page 9

voltage equipment which may generate sparks.
9. This equipment is not designed for internal use or direct cardiac application.
10. Only the patient cable and other accessories supplied by the manufacturer can
be used. Or else, the performance and electric shock protection can not be
guaranteed.
11. Make sure that all electrodes are connected to the patient correctly before
operation.
12. Ensure that the conductive parts of electrodes and associated connectors,
including neutral electrodes, do not come in contact with earth or any other
conducting objects.
13. Electrodes with defibrillator protection should be used while defibrillating.
14. If reusable electrodes with electrode gel are used during defibrillation, ECG
recovery will take more than 10 seconds. The manufacturer recommends the
use of disposable electrodes at all times.
15. Electrodes of dissimilar metals should not be used; otherwise it may cause a
high polarization voltage.
16. There is no danger for patients to use pacemakers. However, if a pacemaker is
used, the results given by the equipment may be invalid, or lose the clinical
significance.
17. Do not touch the patient, bed, table or the equipment while using the ECG
together with a defibrillator or a pacemaker.
18. In order to avoid being burnt, please keep the electrodes far away from the
radio knife while using electrosurgical equipment.
19. 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 60601-1-1. 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.
20. The summation of leakage current should never exceed leakage current limits
while several other units are used at the same time.
21. The potential equalization bar can be connected to that of other equipment
when necessary. Make sure that all these devices are connected to the
potential equalization terminal.
22. The EQUIPMENT is protected against malfunctions caused by electrosurgery
according to the clause 36.202.101 in the standard IEC60601-2-25.
23. The disposable electrodes can only be used for one time.
SE-601 Series Electrocardiograph User Manual
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