IEC 60601-2-34:2000 pdf download.Medical electrical equipment
If the EQUIPMENT has been used together with HIGH-FREQUENCY SURGICAL EQUIPMENT it shall return to the previous operating mode within 10 s after exposure to the field produced by a HIGH-FREQUENCY SURGICAL EQUIPMENT without loss of any stored data.
Compliance shall be tested according to Figures 109, 110 and 111. If the TYPE CF isolation is in the TRANSDUCER, the compliance test shall be according to Figures 110 and 111.
The HIGH-FREQUENCY SURGICAL EQUIPMENT which is used shall comply with IEC 60601-2-2,shall have 300 W of minimum power cut mode capability, 100 W of minimum power coagulating mode capability, and a working frequency of 450 kHz±100 kHz.
a) Test in cut mode
Set the blood pressure monitor to a range of 120 mm Hg to 150 mm Hg and the output power of the HIGH-FREQUENCY SURGICAL EQUIPMENT to the 300 W setting. The monitor shall be calibrated with the zero line visible. Any filter shall be in a wideband position.
Touch the metal contact/block in the test set-up (see Figures 109 and 110) with the active electrode and remove the electrode slowly to get a spark.
Repeat the procedure as described five times. Immediately after the operation S1 shall be opened. The test signal shall be recorded/displayed within 10 s.
b) Test in the coagulation mode Repeat the test in item a) except with a maximum output power of 100 W.
Test of the spray coagulation mode is excluded.
The same test pressure as before is applied again to the TRANSDUCER. The deflection shall be the same as that noted at the beginning of this test, the tolerance allowed by the specification in the ACCOMPANYING DOCUMENTS.
If the EQUIPMENT forms part of a medical electrical system, then the system and the EQUIPMENT shall not be subjected to the above test, unless the EQUIPMENT or part of the EQUIPMENT is separable from the system while remaining functional, in which case the said EQUIPMENT or parts of the EQUIPMENT shall be subjected to the above test.
Replacement:TRANSDUCERS and EQUIPMENT parts containing insulation, the failure of which could result in a safety hazard or changes in essential aspects of performance according to this standard, and which in NORMAL USE are subject to immersion in liquids, shall be watertight according to IPX7 of lEC 60529. Connectors are excluded from this requirement. After the test all requirements of this Particular Standard shall be satisfied. The test need not be performed if examination of the construction and circuit arrangement shows that no safety hazard is possible.IEC 60601-2-34 pdf download.